16 Del. Admin. Code — Health and Safety

# 16 Del. Admin. Code — Health and Safety

## **Department of Health and Social Services** Department of Health and Social Services

### **2000** Division of Developmental Disabilities Services

#### **2100** Eligibility Criteria

##### **16 Del. Admin. Code § 2100-1.0** Purpose {#sec-2100-1.0 omnilex-key=us-de-regs-official--title-16--2100-1.0}

The purpose of the 16 DE Admin. Code 2100 Eligibility Criteria is to set forth standards to determine an applicant's eligibility for the Division of Developmental Disabilities Services (DDDS) supports and services.

**History**
- *4 DE Reg. 228 (07/01/00)*
- *11 DE Reg. 1237 (03/01/08)*
- *26 DE Reg. 391 (11/01/22)*

##### **16 Del. Admin. Code § 2100-2.0** Eligibility Requirements {#sec-2100-2.0 omnilex-key=us-de-regs-official--title-16--2100-2.0}

2.1 Eligibility is established by the following criteria, all of which must be met except when explicitly stated otherwise:

2.1.1 Residency

2.1.1.1 The applicant must be a resident of the State of Delaware; and

2.1.1.2 The applicant must be a U.S. citizen or qualified alien according to DE Medicaid requirements (16 DE Admin. Code 14310). The five-year bar, which qualified aliens are subjected to before Medicaid eligibility, does not apply to non-Medicaid DDDS services.

2.1.2 Age

2.1.2.1 The applicant must have attained a minimum age of 3.

2.1.2.2 The applicant must have documented evidence that the disability originated prior to the age of 22.

2.1.2.3 DDDS may accept a comprehensive assessment and diagnosis of a qualifying condition by a licensed practitioner completed after age 22 after unsuccessful attempts to obtain assessments and records from the developmental period.

2.1.3 Clinical Requirements

2.1.3.1 The applicant must have a disabling condition that meets at least one of the following criteria:

2.1.3.1.1 Intellectual Disability (ID), which can be caused by a brain injury or other neurologically disabling condition. An intellectual disability is characterized by significantly below-average general intellectual functioning with a valid intelligence quotient (IQ) or IQ-equivalent score of approximately 70 or below on a normed and standardized assessment;

2.1.3.1.2 Autism Spectrum Disorder (ASD), as defined by the current version of the American Psychiatric Association's Diagnostic and Statistical Manual (DSM) determined through a comprehensive evaluation by a licensed practitioner or school psychologist, including a detailed developmental history that documents behavioral characteristics of ASD based on the current version of the DSM;

2.1.3.1.3 Prader-Willi Syndrome diagnosis by a licensed practitioner.

2.1.3.2 The applicant must also have significant limitations in adaptive behavior functioning which includes conceptual, social, and practical skills that are learned and performed by people in their everyday lives, as established by the following:

2.1.3.2.1 Score of approximately 70 or below, on the composite score or in at least one domain of a standardized adaptive behavior functioning assessment.

2.1.3.2.2 If there are ratings from two different respondents, scores from different raters should be consistent with one another and approximately 70 or below as noted in section 2.1.3.2.1.

2.1.4 Assessment Requirements

2.1.4.1 Assessments must be performed by a licensed practitioner or school psychologist using the most recent editions of standardized assessments for the period accepted by the Division. Accepted standardized assessments are published on the DDDS website. DDDS may accept other assessments if they are comprehensive, structured, and use instruments that are normed and standardized.

2.1.4.2 The assessment for ASD must include a detailed developmental history with evidence that behavioral characteristics of ASD (based on the current DSM) were present during the developmental period. A detailed developmental history interview is necessary because standardized measures to diagnose ASD retrospectively do not exist.

**History**
- *4 DE Reg. 228 (07/01/00)*
- *11 DE Reg. 1237 (03/01/08)*
- *26 DE Reg. 391 (11/01/22)*

##### **16 Del. Admin. Code § 2100-3.0** Exception to Clinical Requirements for Applicants Aged Three Through Age Eight {#sec-2100-3.0 omnilex-key=us-de-regs-official--title-16--2100-3.0}

3.1 If the requirements in subsection 2.1.3 cannot be met for an applicant aged three through eight, provisional eligibility may be granted with clinical documentation to support a minimum of one of the following conditions:

3.1.1 There exists the possibility of a qualifying condition listed in subsection 2.1.3, however, additional assessment is required; or

3.1.2 A minimum of two delays in the following developmental domains:

3.1.2.1 Cognition;

3.1.2.2 Communication (expressive or receptive);

3.1.2.3 Physical (gross or fine motor);

3.1.2.4 Social;

3.1.2.5 Emotional;

3.1.2.6 Adaptive behavior; or

3.1.3 A diagnosed congenital or acquired condition with documentation that indicates that the condition results in a high probability of a future intellectual/developmental disability as an alternative to those described in subsection 2.1.3.

3.2 When the applicant reaches age 9, provisional eligibility ends and assessments must support a disabling condition as defined in subsection 2.1.3.

**History**
- *4 DE Reg. 228 (07/01/00)*
- *11 DE Reg. 1237 (03/01/08)*
- *26 DE Reg. 391 (11/01/22)*

##### **16 Del. Admin. Code § 2100-4.0** Eligibility Determined Without All Documentation {#sec-2100-4.0 omnilex-key=us-de-regs-official--title-16--2100-4.0}

4.1 In cases of bona fide extraordinary or exigent circumstances, DDDS may determine eligibility without one or more of the required pieces of documentation.

4.2 If eligibility is determined without the required documentation, DDDS reserves the right to redetermine eligibility if such documentation becomes available later.

**History**
- *4 DE Reg. 228 (07/01/00)*
- *11 DE Reg. 1237 (03/01/08)*
- *26 DE Reg. 391 (11/01/22)*

##### **16 Del. Admin. Code § 2100-5.0** Review of Updated Assessments and Redetermination of Eligibility {#sec-2100-5.0 omnilex-key=us-de-regs-official--title-16--2100-5.0}

Until an individual reaches the age of 22, DDDS reserves the right to review updated assessments and redetermine eligibility at any time, including requiring additional testing that must be completed prior to the age of 22.

**History**
- *4 DE Reg. 228 (07/01/00)*
- *11 DE Reg. 1237 (03/01/08)*
- *26 DE Reg. 391 (11/01/22)*

#### **2101** Agency Appeal Process

##### **16 Del. Admin. Code § 2101-1.0** Definitions {#sec-2101-1.0 omnilex-key=us-de-regs-official--title-16--2101-1.0}

The following words and terms, when used in this regulation, shall have the following meaning unless the context clearly indicates otherwise:

“Appeal” means a DDDS internal evidentiary review of a decision by an objective committee assigned by the Division Director or designee.

“Applicant” means any person who is applying for services from the DDDS.

“Individual Rights Complaint” means the DDDS formal process for asserting that the rights of an individual served have been violated, an internal review concerning the reported rights violation and the identification of a plan to improve the situation.

“Risk Management Committee” means the internal Division committee responsible for reviewing identified focus areas situations that present actual or potential danger to individuals served and staff; subsequently developing risk reduction strategies.

**History**
- *13 DE Reg. 1458 (05/01/10)*

##### **16 Del. Admin. Code § 2101-2.0** Situations/issues eligible for review. {#sec-2101-2.0 omnilex-key=us-de-regs-official--title-16--2101-2.0}

Situtions/issues to be reviewed via the DDDS appeals process include the following:

2.1 Decisions that involve the omission of choice between institutional care and home and community based services.

2.2 Denial of eligibility for DDDS services.

2.3 Denial of service provider of choice.

2.4 Denial, reduction, suspension or termination of services.

2.5 Dissatisfaction with the outcome of an Individual Rights Complaint.

**History**
- *13 DE Reg. 1458 (05/01/10)*

##### **16 Del. Admin. Code § 2101-3.0** Resolution Prior to Appeal Request {#sec-2101-3.0 omnilex-key=us-de-regs-official--title-16--2101-3.0}

The Division encourages the appellant to attempt to resolve the situation being contested, prior to requesting an appeal, although all informal resolution avenues do not need to be exhausted, as a pre-requisite.

**History**
- *13 DE Reg. 1458 (05/01/10)*

##### **16 Del. Admin. Code § 2101-4.0** Decision Implementation. {#sec-2101-4.0 omnilex-key=us-de-regs-official--title-16--2101-4.0}

The implementation of a DDDS decision shall be postponed pending the decision of a DDDS appeal or Medicaid Fair Hearing, unless it has already been implemented or by agreement of the appellant and the Division.

**History**
- *13 DE Reg. 1458 (05/01/10)*

##### **16 Del. Admin. Code § 2101-5.0** Medicaid Fair Hearing Request. {#sec-2101-5.0 omnilex-key=us-de-regs-official--title-16--2101-5.0}

A Medicaid recipient may request a Division of Social Services (DSS) Medicaid Fair hearing at any point in the appeals process, up to ninety (90) days following receipt of a written notice of the DDDS decision that the recipient decides to appeal.

**History**
- *13 DE Reg. 1458 (05/01/10)*

##### **16 Del. Admin. Code § 2101-6.0** Appellant Contact {#sec-2101-6.0 omnilex-key=us-de-regs-official--title-16--2101-6.0}

The DDDS Appeals Committee chairperson shall make efforts to contact the appellant within five (5) working days of receiving the appeals request, unless that appeal is for a disputed eligibility decision. In that case, the DDDS Appeals Committee chairperson shall request a copy of the appellant’s intake record within five (5) days of receiving the appeal request and make efforts to contact the appellant within five (5) working days of receiving a copy of the intake record.

**History**
- *13 DE Reg. 1458 (05/01/10)*

##### **16 Del. Admin. Code § 2101-7.0** Appeals Request Review. {#sec-2101-7.0 omnilex-key=us-de-regs-official--title-16--2101-7.0}

The DDDS Appeals Committee chairperson shall review the appeals request with the appellant, provide clarification as necessary, explain the appeals process and schedule an appeal review at the following month’s appeal hearing contingent on providing a 14 calendar days notice.

**History**
- *13 DE Reg. 1458 (05/01/10)*

##### **16 Del. Admin. Code § 2101-8.0** Meeting with the Appellant. {#sec-2101-8.0 omnilex-key=us-de-regs-official--title-16--2101-8.0}

The DDDS Appeals Committee shall meet with the appellant in person, unless otherwise requested, and listen to the reason(s) that a decision is disputed. The appellant has the right to invite guests to the appeal hearing and present additional information for consideration. The appellant shall have the opportunity to ask questions, request clarification and receive answers. The person or designee who initially made the decision being disputed shall also appear at the appeal hearing and explain the rationale for his/her decision.

**History**
- *13 DE Reg. 1458 (05/01/10)*

##### **16 Del. Admin. Code § 2101-9.0** Division Director Notification {#sec-2101-9.0 omnilex-key=us-de-regs-official--title-16--2101-9.0}

The Division Director shall be notified of the Appeals Committee’s recommendations relative to the issue(s) being appealed, with five (5) working days of the appeal hearing.

**History**
- *13 DE Reg. 1458 (05/01/10)*

##### **16 Del. Admin. Code § 2101-10.0** Notice of Final appeal Disposition. {#sec-2101-10.0 omnilex-key=us-de-regs-official--title-16--2101-10.0}

The Division Director shall send written notification to the appellant of the final appeal disposition, within fifteen (15) working days of the appeal hearing. The notification shall include a notice regarding the right to request a Division of Social Services (DSS) Medicaid Fair Hearing, if the aggrieved person is a Medicaid recipient or applying for a Medicaid service.

**History**
- *13 DE Reg. 1458 (05/01/10)*

##### **16 Del. Admin. Code § 2101-11.0** Effect of Appeal on Medicaid Fair Hearing or other Review Processess. {#sec-2101-11.0 omnilex-key=us-de-regs-official--title-16--2101-11.0}

A DDDS Appeal shall not be a pre-requisite for requesting a DSS Medicaid Fair Hearing nor shall the availability of a DDDS Appeal take the place of or prevent access to other review processes otherwise available under law or Departmental policy.

**History**
- *13 DE Reg. 1458 (05/01/10)*

##### **16 Del. Admin. Code § 2101-12.0** Appeal Statistics and Trends. {#sec-2101-12.0 omnilex-key=us-de-regs-official--title-16--2101-12.0}

The DDDS Risk Management Committee shall review appeal statistics and trends, on an annual basis or as requested by the committee chair or Division Director.

**History**
- *13 DE Reg. 1458 (05/01/10)*

#### **2102** Autism Service Providers

##### **16 Del. Admin. Code § 2102-1.0** Purpose {#sec-2102-1.0 omnilex-key=us-de-regs-official--title-16--2102-1.0}

Title 18, Sections 3361(f) and 3570A of the Delaware Code require that the Department of Health and Social Services promulgate regulations establishing standards for certifying qualified autism services providers. Once the regulations are promulgated, payment for the treatment of autism spectrum disorders covered under Sections 3361(f) and 3570A shall only be required to be made to autism services providers who meet the standards.

**History**
- *16 DE Reg. 1170 (05/01/13)*

##### **16 Del. Admin. Code § 2102-2.0** Definitions {#sec-2102-2.0 omnilex-key=us-de-regs-official--title-16--2102-2.0}

“Applied behavior analysis” or “ABA” means the design, implementation, and evaluation of environmental modifications, using behavioral stimuli and consequences, to produce socially significant improvement in human behavior, including the use of direct observation, measurement, and functional analysis of the relationship between environment and behavior.

“Autism services provider” means any person, entity, or group authorized by this regulation that designs, supervises, and/or provides treatment of autism spectrum disorders. This includes licensed physicians, psychologists or their assistants, psychiatrists, speech therapists or their aides, occupational therapists or their aides, physical therapists or their assistants, practitioners with the national certification of board-certified behavior analyst (Board Certified Behavior Analyst-Doctoral® (BCBA-D®), Board Certified Behavior Analyst ® (BCBA®), Board Certified Assistant Behavior Analyst ® (BCaBA®) working under supervision), and behavioral technicians working under the supervision of a board-certified behavior analyst (BCBA® or BCBA-D®), licensed professional counselors of mental health, licensed clinical social workers, and advanced practice nurses.

“Autism spectrum disorders” means any of the pervasive developmental disorders as defined by the most recent edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM), including Autistic Disorder, Asperger’s Disorder and Pervasive Developmental Disorder Not Otherwise Specified, as such may be amended hereafter from time to time.

“Behavioral health treatment” means professional counseling, guidance services or treatment programs, including applied behavior analysis, that are necessary to develop, maintain, or restore, to the maximum extent practicable, the functioning of an individual. This definition also applies to treatment or counseling to improve social skills and function.

“Behavioral Technician” means a person meeting the requirements set forth in Section 3 of this regulation who implements components of an applied behavior analysis treatment plan designed and supervised by a Board Certified Behavior Analyst® (BCBA) or a Board Certified Behavior Analyst-Doctoral® (BCBA-D).

“Medically necessary” means reasonably expected to do the following:

“Pharmacy care” means medications prescribed by a licensed practitioner and any health-related services deemed medically necessary to determine the need or effectiveness of the medications.

“Psychiatric care” means direct or consultative services provided by a psychiatrist licensed in the state in which the psychiatrist practices.

“Psychological care” means direct or consultative services provided by a psychologist licensed in the state in which the psychologist practices or by a psychological assistant acting under the supervision of a psychologist.

“Screening and diagnosis of autism spectrum disorders” means medically necessary assessments, evaluations, or tests to diagnose whether an individual has or is at risk for one of the autism spectrum disorders.

“Therapeutic care” means services provided by speech, occupational, or physical therapists or an aide or assistant acting under their supervision.

“Treatment for autism spectrum disorders” shall include the following care prescribed or ordered for an individual diagnosed with one of the autism spectrum disorders by a licensed physician or licensed psychologist who determines the care to be medically necessary:

**History**
- *16 DE Reg. 1170 (05/01/13)*

##### **16 Del. Admin. Code § 2102-3.0** Qualified Autism Service Providers {#sec-2102-3.0 omnilex-key=us-de-regs-official--title-16--2102-3.0}

3.1 If an autism services provider is currently certified as a BCBA or BCBA-D, such autism services provider shall be deemed to have met the standards established under this section to provide applied behavior analysis services. The Behavior Analyst Certification Board sets forth a task list of acceptable activities of an individual it certifies and maintains disciplinary and ethical standards. Certified individuals must act within the scope of these documents and their certification, as currently set forth and as subsequently amended by the Behavior Analyst Certification Board (BACB).

3.2 Professionals and their aides and assistants listed in 2.0 may provide treatment for autism spectrum disorders, provided that such services are medically necessary and within the professional’s scope of practice and scope of competence and training. Aides and assistants must work under the direction and supervision of the professional. Only people certified as a BCBA or BCBA-D or behavioral technicians who work under the supervision of a BCBA or BCBA-D are considered qualified, under these regulations, to provide applied behavior analysis.

3.3 Behavioral Technicians who work under the supervision of a BCBA or BCBA-D and who meet the criteria listed below may implement components of applied behavior analysis treatment plans. The supervising BCBA or BCBA-D must verify that the criteria set forth have been met.

3.3.1 Supervision by a BCBA or BCBA-D includes clinical management and case supervision and may include direct treatment. The ratio of such supervision hours provided by the BCBA or BCBA-D to those direct treatment hours provided by a behavioral technician should reflect the needs of the client but shall not be less than 1.5:10 per week. In the case that less than 10 hours per week of ABA is prescribed and delivered, a minimum of 1 hour of supervision per week is required.

3.3.2 Other requirements for behavioral technicians:

3.3.2.1 High School Diploma or GED;

3.3.2.2 Proof of passing a federal and state criminal background and child and adult abuse registry check;

3.3.2.3 Annual CPR certification;

3.3.2.4 Annual signed statement that they have read and understand an explanation of Delaware’s mandatory child abuse reporting law (including hotline);

3.3.2.5 Signed statement that they have read and understand an explanation of HIPAA;

3.3.2.6 Proof of successful completion of an online or in-person course on Autism Spectrum Disorders that is offered by a provider on the list of continuing education providers authorized by the BACB, provided by any accredited two or four year college (online or in-person), or provided by an ABA or behavioral health agency training its own staff.

3.3.2.7 Proof of completion of competency-based training in implementing applied behavior analysis procedures delivered and verified by the supervising BCBA, or BCBA-D. A person holding a current certification of board certified assistant behavior analyst (BCaBA) is deemed to have met this requirement.

3.3.2.8 Proof of successful completion of an online or in-person course on Applied Behavior Analysis principles that is offered by a provider on the list of continuing education providers authorized by the BACB, provided by any accredited two or four year college (online or in-person), or provided by an ABA or behavioral health agency training its own staff so long as such training is done by a BCBA or BCBA-D.

3.3.2.9 After completion of the above, a minimum of 10 hours of competency-based training and direct service, observed by the BCBA or BCBA-D, before providing one-on-one service.

**History**
- *16 DE Reg. 1170 (05/01/13)*

##### **16 Del. Admin. Code § 2102-4.0** Disqualification of Autism Service Providers {#sec-2102-4.0 omnilex-key=us-de-regs-official--title-16--2102-4.0}

4.1 A person who meets a definition of an Autism Service Provider under section 3.0 becomes disqualified if

4.1.1 The BCBA or BCBA-D no longer has a credential issued by the Behavior Analyst Certification Board.

4.1.2 The professional license under which a person practices is suspended or revoked;

4.1.3 The person is under investigation and review for or is substantiated for or convicted of abuse, mistreatment, neglect, or exploitation; or

4.1.4 An aide, assistant, or behavioral technician ceases employment or the agreement under which the person is supervised by the Autism Service Provider is terminated.

**History**
- *16 DE Reg. 1170 (05/01/13)*

### **3000** Division of Health Care Quality

#### **3101** Adult Abuse Registry

##### **16 Del. Admin. Code § 3101-1.0** Definitions {#sec-3101-1.0 omnilex-key=us-de-regs-official--title-16--3101-1.0}

"Abuse" shall have the same meaning as contained in 16 Del.C. §1131, and shall include mistreatment, neglect and financial exploitation as defined therein.

"Child Care Facility" means any child care facility which is required to be licensed by the Department of Services for Children, Youth and Their Families.

"Contractor" means an entity under contract to provide services for more than 20 hours per week (aggregate) and for more than six weeks in a twelve month period for a health care service provider, and whose employees have the opportunity for direct access to persons receiving care. For purposes of these regulations, contractor does not include construction contractors.

"Department" means the Department of Health and Social Services.

"Direct Access" means the opportunity to have personal contact with persons receiving care during the course of one's assigned duties.

“Division" means the Division of Long Term Care Residents Protection.

"Health Care Service Provider" means any person or entity that provides services in a custodial or residential setting where health, nutritional or personal care is provided for persons receiving care, including but not limited to, hospitals, home health care agencies, adult care facilities, temporary employment agencies and contractors that place employees or otherwise provide services in custodial or residential settings for persons receiving care, and hospice agencies. Health Care Service Provider does not include any private individual who is seeking to hire a self-employed health caregiver in a private home.

"Nursing Facility and Similar Facility" means any facility required to be licensed under 16 Del.C. Ch. 11. This includes, but is not limited to, facilities commonly called nursing homes, assisted living facilities, intermediate care facilities for persons with mental retardation, neighborhood group homes, family care homes and rest residential care facilities. Also included are the Stockley Center, the Delaware Psychiatric Center and hospitals certified by the Department of Health and Social Services pursuant to 16 Del.C. §5001 or 5136.

“Person Receiving Care" means any person who, because of his/her physical or mental condition, requires a level of care and services suitable to his/her needs to contribute to his/her health, comfort and welfare.

"Person Seeking Employment" means any person applying for employment with or in a health care service provider, nursing facility or similar facility that may afford direct access to persons receiving care at such facility, or a person applying for licensure to operate a child care facility or nursing facility and similar facility. It shall also include a self-employed health caregiver who has direct access in any private home.

"Substantiated Pending Appeal" refers to a placement on the Registry based on an investigative finding prior to the subject exercising his/her right to appeal.

"Substantiated Abuse" means that, weighing the facts and circumstances, a reasonable person has concluded by a preponderance of evidence that the identified individual has committed adult abuse for the purpose of placement on the Adult Abuse Registry.

**History**
- *5 DE Reg. 1073 (11/1/01)*
- *13 DE Reg. 1308 (04/01/10)*
- *5 DE Reg. 1073 (11/1/01)*
- *13 DE Reg. 1314 (04/01/10)*
- *5 DE Reg. 1073 (11/1/01)*
- *5 DE Reg. 1073 (11/1/01)*
- *7 DE Reg. 82 (7/1/03)*
- *13 DE Reg. 1314 (04/01/10)*
- *5 DE Reg. 1073 (11/1/01)*
- *5 DE Reg. 1073 (11/1/01)*
- *13 DE Reg. 1314 (04/01/10)*
- *5 DE Reg. 1073 (11/1/01)*
- *5 DE Reg. 1073 (11/1/01)*

##### **16 Del. Admin. Code § 3101-2.0** Use of Registry {#sec-3101-2.0 omnilex-key=us-de-regs-official--title-16--3101-2.0}

2.1 No health care service provider, to include nursing and similar facilities, or child care facility shall hire any person seeking employment or retain any contractors without conducting a check of the person through the on-line Adult Abuse Registry available at the Division's website. The provider shall maintain a copy of the results of the check to demonstrate compliance with this requirement.

2.1.1 When exigent circumstances exist which require an employer to fill a position in order to maintain the required or desired level of service, the employer may hire a person seeking employment on a conditional basis after the employer has requested an Adult Abuse Registry check.

2.1.2 The person shall be informed in writing, and shall acknowledge in writing, that his or her employment is conditional, and contingent upon receipt of the Adult Abuse Registry check.

2.2 Private individuals seeking to hire an individual to provide health care services in a private residence may conduct a check of the on-line Adult Abuse Registry available at the Division's website. An individual who does not have access to the internet may submit a short letter of request to the Division of Long Term Care Residents Protection (DLTCRP) # 3 Mill Road, Suite 308, Wilmington, DE 19806, fax number (302) 577-6673 by mail or fax.

**History**
- *5 DE Reg. 1073 (11/1/01)*
- *13 DE Reg. 1308 (04/01/10)*
- *5 DE Reg. 1073 (11/1/01)*
- *13 DE Reg. 1314 (04/01/10)*
- *5 DE Reg. 1073 (11/1/01)*
- *5 DE Reg. 1073 (11/1/01)*
- *7 DE Reg. 82 (7/1/03)*
- *13 DE Reg. 1314 (04/01/10)*
- *5 DE Reg. 1073 (11/1/01)*
- *5 DE Reg. 1073 (11/1/01)*
- *13 DE Reg. 1314 (04/01/10)*
- *5 DE Reg. 1073 (11/1/01)*
- *5 DE Reg. 1073 (11/1/01)*

##### **16 Del. Admin. Code § 3101-3.0** Investigation of Adult Abuse {#sec-3101-3.0 omnilex-key=us-de-regs-official--title-16--3101-3.0}

3.1 The Division shall investigate any individual against whom an allegation of adult abuse has been made in accordance with the time frames delineated in 16 Del.C. §1134(d).

3.2 If the investigation substantiates pending appeal that the alleged abuse occurred, the Division's Investigations Unit Chief shall enter on the Adult Abuse Registry, with a finding of "Substantiated Pending Appeal," the individual's name, date/time of the incident, a description of same and the length of time the finding shall remain on the Registry.

3.3 The Division may accept preliminary investigations by a state agency or an entity contracted by a state agency. The Division will review and may revise the findings upon further investigation.

3.4 Upon placement of a person on the Adult Abuse Registry, the Division will notify the facility from which the complaint originated as well as the current employer, if different, and the victim that the person is on the Registry as "Substantiated Pending Appeal."

**History**
- *5 DE Reg. 1073 (11/1/01)*
- *13 DE Reg. 1308 (04/01/10)*
- *5 DE Reg. 1073 (11/1/01)*
- *13 DE Reg. 1314 (04/01/10)*
- *5 DE Reg. 1073 (11/1/01)*
- *5 DE Reg. 1073 (11/1/01)*
- *7 DE Reg. 82 (7/1/03)*
- *13 DE Reg. 1314 (04/01/10)*
- *5 DE Reg. 1073 (11/1/01)*
- *5 DE Reg. 1073 (11/1/01)*
- *13 DE Reg. 1314 (04/01/10)*
- *5 DE Reg. 1073 (11/1/01)*
- *5 DE Reg. 1073 (11/1/01)*

##### **16 Del. Admin. Code § 3101-4.0** Administrative Hearings {#sec-3101-4.0 omnilex-key=us-de-regs-official--title-16--3101-4.0}

4.1 An individual against whom an allegation is substantiated pending appeal shall be notified by certified mail at his/her home address, to be followed by written notice in care of his/her current employer at the discretion of the Division, that his/her name has been entered on the Adult Abuse Registry and shall be offered a right to an administrative hearing. The burden of proof in such hearing shall be on the Division. Individuals shall be informed upon completion of the investigation of the following:

4.1.1 The date and time of the incident if known.

4.1.2 The name and type of facility where the incident occurred.

4.1.3 A brief description of the incident.

4.1.4 Length of time the finding remains on the Adult Abuse Registry.

4.2 All requests for an administrative hearing must be received in writing, postmarked within 30 days of the date of the notice that a finding of abuse has been substantiated pending appeal. The Director or his/her designee shall dismiss untimely requests for hearing except when the individual submits evidence of good cause.

4.3 An individual who fails to request an administrative hearing as described above shall have his/her name and information regarding the incident changed from a finding of "Substantiated Pending Appeal" to a finding of "Substantiated Abuse" on the Adult Abuse Registry. At that time the Division shall notify the individual, the facility from which the complaint originated as well as the current employer, if different, and the victim that the individual is on the Registry with a finding of "Substantiated Abuse."

4.4 An individual who has entered a plea or who has been convicted by a court of law of a criminal offense based on the same conduct that resulted in placement on the Adult Abuse Registry shall have the right to an administrative hearing solely to challenge the proposed length of time of registration on the Adult Abuse Registry.

4.5 The hearing officer shall have the power to compel the attendance of witnesses and the production of evidence. Under no circumstance shall the hearing officer order the release of the investigative report and documents attached thereto, provided however, the hearing officer may order the release of statements of witnesses.

4.6 The hearing officer should receive requests for witnesses and/or the production of evidence no less than ten business days prior to the hearing date.

4.7 The individual shall be afforded an opportunity to appear with or without an attorney, submit documentary evidence, present witnesses, and question any witness the Division presents. Limited continuances shall be granted for good cause.

4.8 If, at the conclusion of the hearing, the hearing officer concludes by a preponderance of evidence, that the identified individual has committed adult abuse, for the purpose of placement on the Adult Abuse Registry, a notice of "Substantiated Abuse" shall be placed on the Adult Abuse Registry. If, at the conclusion of the hearing, the hearing officer concludes that the individual has not committed adult abuse, the finding of "Substantiated Pending Appeal" shall be removed from the Adult Abuse Registry.

4.9 The hearing officer shall render a written decision within thirty working days of the hearing and will notify the individual, the Division, the facility and the victim of the decision. The notice will specify the reasons for the decision and, if the finding is substantiated, the length of time the finding of substantiated abuse shall remain on the Adult Abuse Registry.

4.10 Any person placed on the Adult Abuse Registry shall have the right to appeal the decision within thirty days of the finding. The decision of the hearing officer may be appealed on the record to Superior Court. Appeals of hearing officer decisions are governed by the Administrative Procedures Act, Title 29, Chapter 101.

**History**
- *5 DE Reg. 1073 (11/1/01)*
- *13 DE Reg. 1308 (04/01/10)*
- *5 DE Reg. 1073 (11/1/01)*
- *13 DE Reg. 1314 (04/01/10)*
- *5 DE Reg. 1073 (11/1/01)*
- *5 DE Reg. 1073 (11/1/01)*
- *7 DE Reg. 82 (7/1/03)*
- *13 DE Reg. 1314 (04/01/10)*
- *5 DE Reg. 1073 (11/1/01)*
- *5 DE Reg. 1073 (11/1/01)*
- *13 DE Reg. 1314 (04/01/10)*
- *5 DE Reg. 1073 (11/1/01)*
- *5 DE Reg. 1073 (11/1/01)*

##### **16 Del. Admin. Code § 3101-5.0** Length of Time on the Adult Abuse Registry {#sec-3101-5.0 omnilex-key=us-de-regs-official--title-16--3101-5.0}

5.1 The length of time on the Adult Abuse Registry shall be based on the seriousness of the incident and whether there exists a pattern of adult abuse. Evidence of mitigating circumstances may be considered.

5.2 The names of registrants with findings of abuse, neglect or misappropriation entered on the Registry of Nurse Aides created pursuant to 42 CFR §483 shall be entered on the Adult Abuse Registry with a finding of substantiated abuse. There shall be a right of appeal for findings entered on the Adult Abuse Registry under this section solely to challenge the proposed length of time of registration on the Adult Abuse Registry.

5.3 Upon final disposition of the allegation, the Division shall notify, in writing, the victim, the facility where the incident occurred as well as the current employer of the individual, if different, of the final disposition.

**History**
- *5 DE Reg. 1073 (11/1/01)*
- *13 DE Reg. 1308 (04/01/10)*
- *5 DE Reg. 1073 (11/1/01)*
- *13 DE Reg. 1314 (04/01/10)*
- *5 DE Reg. 1073 (11/1/01)*
- *5 DE Reg. 1073 (11/1/01)*
- *7 DE Reg. 82 (7/1/03)*
- *13 DE Reg. 1314 (04/01/10)*
- *5 DE Reg. 1073 (11/1/01)*
- *5 DE Reg. 1073 (11/1/01)*
- *13 DE Reg. 1314 (04/01/10)*
- *5 DE Reg. 1073 (11/1/01)*
- *5 DE Reg. 1073 (11/1/01)*

##### **16 Del. Admin. Code § 3101-6.0** Removal of a Person from the Adult Abuse Registry {#sec-3101-6.0 omnilex-key=us-de-regs-official--title-16--3101-6.0}

6.1 The Department shall be authorized to remove a person from the Adult Abuse Registry before the expiration of his/her registration period when the Department deems that the person no longer poses a threat to any person receiving care in accordance with 11 Del.C. §8564(g) or where equity requires.

6.2 A person whose name has been placed on the Adult Abuse Registry shall have the right to petition the Division, in writing, for the removal of his/her name from the Registry. Said petitioner must demonstrate:

6.2.1 A minimum of twelve months has passed since his/her placement on the Registry.

6.2.2 Affirmative steps have been taken to correct behavior that led to placement on the Registry, i.e. anger management counseling, drug/alcohol treatment, sensitivity training, etc.

6.2.3 Demonstrated improved behavior through work references.

6.3 The Division will evaluate the information provided by the petitioner and respond in writing within 60 days of receipt of all information provided by the petitioner. The Division is authorized to grant or deny the removal based on the review of the information presented. If the Division denies the request, the petitioner may request a hearing to appeal the denial, or reapply for the removal after 6 months or when the petitioner can produce evidence of performance of the affirmative steps listed above.

**History**
- *5 DE Reg. 1073 (11/1/01)*
- *13 DE Reg. 1308 (04/01/10)*
- *5 DE Reg. 1073 (11/1/01)*
- *13 DE Reg. 1314 (04/01/10)*
- *5 DE Reg. 1073 (11/1/01)*
- *5 DE Reg. 1073 (11/1/01)*
- *7 DE Reg. 82 (7/1/03)*
- *13 DE Reg. 1314 (04/01/10)*
- *5 DE Reg. 1073 (11/1/01)*
- *5 DE Reg. 1073 (11/1/01)*
- *13 DE Reg. 1314 (04/01/10)*
- *5 DE Reg. 1073 (11/1/01)*
- *5 DE Reg. 1073 (11/1/01)*

##### **16 Del. Admin. Code § 3101-7.0** Disclosure of Adult Abuse Registry Records {#sec-3101-7.0 omnilex-key=us-de-regs-official--title-16--3101-7.0}

Except as otherwise provided in these regulations, the dissemination of information contained in the Adult Abuse Registry shall be limited as follows:

7.1 Hearing Officer Opinions shall be released upon request to the following:

7.1.1 The subject of the hearing.

7.1.2 A victim identified by name in the record or his/her legal representative.

7.1.3 Law enforcement officials pursuant to an official investigation.

7.1.4 The Long Term Care Ombudsman pursuant to a complaint from a victim identified in the record.

7.1.5 The Medicaid Fraud Control Unit of the Department of Justice.

7.1.6 The Division of Professional Regulation if a finding of substantiated abuse pertains to a licensed professional.

7.2 Investigative files shall be released upon request to:

7.2.1 Law enforcement officials pursuant to an official investigation.

7.2.2 The Medicaid Fraud Control Unit of the Department of Justice.

7.2.3 Rights protection agencies otherwise entitled under applicable federal or state law.

Addendum Reporting To Nurse Aide Registry

In accordance with 42 CFR §483, the Division of Long Term Care Residents Protection will report findings of abuse to the Nurse Aide Registry under the following procedure:

1. When the Division has substantiated pending appeal a finding of abuse, neglect, mistreatment or financial exploitation against a certified nurse assistant, a determination will be made whether the substantiated findings meet the criteria required in the federal regulations or the criteria in state statute and regulations.

2. If the findings support the criteria for abuse, mistreatment or misappropriation of property in the federal regulations, the certified nurse assistant will be notified that his/her name is both reported to the Nurse Aide Registry and placed on the Adult Abuse Registry, and that he/she has a right to a hearing. The CNA will also be notified that, with regard to the Nurse Aide Registry, a substantiated finding will result in a lifetime prohibition against employment in a federally certified facility.

3. If the findings support the criteria for neglect in the federal regulations, the certified nurse assistant will be notified that his/her name is both reported to the Nurse Aide Registry and placed on the Adult Abuse Registry, and that he/she has a right to a hearing. The CNA will also be notified that, with regard to the Nurse Aide Registry, a substantiated finding of neglect will result in a lifetime prohibition against employment in a federally certified facility. However, the CNA will be further informed of his/ her right to petition the Division to have the report removed from the Nurse Aide Registry in accordance with §1819(g)(1)(D) of the Social Security Act.

4. The notice to the certified nurse assistant will include an explanation that the hearing described in the Adult Abuse Registry regulations will also consider the placement of the CNA on the Nurse Aide Registry. The CNA will be informed that if the evidence presented at a hearing does not warrant a finding of abuse, neglect, mistreatment or misappropriation of property under the federal regulations, the evidence will be considered to determine whether it meets the criteria for abuse, neglect, mistreatment or financial exploitation under the state Adult Abuse statute.

**History**
- *5 DE Reg. 1073 (11/1/01)*
- *13 DE Reg. 1308 (04/01/10)*
- *5 DE Reg. 1073 (11/1/01)*
- *13 DE Reg. 1314 (04/01/10)*
- *5 DE Reg. 1073 (11/1/01)*
- *5 DE Reg. 1073 (11/1/01)*
- *7 DE Reg. 82 (7/1/03)*
- *13 DE Reg. 1314 (04/01/10)*
- *5 DE Reg. 1073 (11/1/01)*
- *5 DE Reg. 1073 (11/1/01)*
- *13 DE Reg. 1314 (04/01/10)*
- *5 DE Reg. 1073 (11/1/01)*
- *5 DE Reg. 1073 (11/1/01)*

#### **3102** Long Term Care Transfer, Discharge and Readmission Procedures

##### **16 Del. Admin. Code § 3102-1.0** Purpose {#sec-3102-1.0 omnilex-key=us-de-regs-official--title-16--3102-1.0}

This regulation applies to decisions by licensed facilities to transfer or discharge a resident. It prescribes the process for providing an impartial hearing to a resident.

This regulation does not extend to decisions of DHSS, or any of its Divisions, to deny, suspend, delay, reduce, or terminate benefits. The regulations governing appeals related to benefit eligibility are found at 16 DE Admin. Code §5000. Be aware that the appeal requirements are different from the requirements in this regulation.

**History**
- *24 DE Reg. 275 (09/01/20)*
- *24 DE Reg. 275 (09/01/20)*
- *24 DE Reg. 275 (09/01/20)*
- *24 DE Reg. 275 (09/01/20)*
- *16 DE Reg. 296 (09/01/12)*
- *24 DE Reg. 275 (09/01/20)*

##### **16 Del. Admin. Code § 3102-2.0** Definitions {#sec-3102-2.0 omnilex-key=us-de-regs-official--title-16--3102-2.0}

“DHSS” means the Department of Health and Social Services

“Division” means the Division of Health Care Quality.

“Legal representative” or “authorized representative” means a resident’s: guardian; agent pursuant to a power of attorney, advanced health care directive, or similar document; or authorized representative pursuant to 16 Del.C. §1122.

“Party” means the resident or resident’s legal or authorized representative and the facility.

“Resident” means resident or patient.

**History**
- *24 DE Reg. 275 (09/01/20)*
- *24 DE Reg. 275 (09/01/20)*
- *24 DE Reg. 275 (09/01/20)*
- *24 DE Reg. 275 (09/01/20)*
- *16 DE Reg. 296 (09/01/12)*
- *24 DE Reg. 275 (09/01/20)*

##### **16 Del. Admin. Code § 3102-3.0** Transfer, discharge and readmission rights of residents in a certified skilled nursing facility or a certified nursing facility as defined in 42 CFR §483.5 or an Intermediate Care facility (ICF/MR) as defined in 42 CFR §440.150. {#sec-3102-3.0 omnilex-key=us-de-regs-official--title-16--3102-3.0}

3.1 Transfer and discharge requirements. The facility must permit each resident to remain in the facility, and not transfer or discharge the resident from the facility unless:

3.1.1 The transfer or discharge is necessary for the resident's welfare and the resident's needs cannot be met in the facility. If the resident appeals a notice of discharge based on this section, the facility will not be cited during the pendency of the appeal for housing a resident whose needs exceed the permitted level of care in that facility.

3.1.2 The transfer or discharge is appropriate because the resident's health has improved sufficiently so the resident no longer needs the services provided by the facility;

3.1.3 The safety of individuals in the facility is endangered;

3.1.4 The health of individuals in the facility would otherwise be endangered;

3.1.5 The resident has failed, after reasonable and appropriate notice, to pay for (or to have paid under Medicare or Medicaid) a stay at the facility. For a resident who becomes eligible for Medicaid after admission to a facility, the facility may charge a resident only allowable charges under Medicaid; or

3.1.6 The facility ceases to operate.

3.2 Documentation. When the facility transfers or discharges a resident under any of the circumstances specified in subsections 3.1.1 through 3.1.5 of this regulation, the resident's clinical record must be documented. The documentation must be made by:

3.2.1 The resident's physician when transfer or discharge is necessary in subsection 3.1.1 or subsection 3.1.2 of this regulation; and

3.2.2 A physician when transfer or discharge is necessary in subsection 3.1.4 of this regulation.

3.3 Notice before transfer. Before a facility transfers or discharges a resident, the facility must:

3.3.1 Notify the resident and, if known, a family member or legal representative of the resident of the transfer or discharge and the reasons for the move in writing and in a language and manner they understand;

3.3.2 Provide a copy of the notice to the Division; the State Long-Term Care (LTC) Ombudsman; the resident’s Delaware Medicaid managed care organization (MCO), if any; any DHSS agency involved in the resident’s placement in the facility, including Adult Protective Services (APS); and the protection and advocacy agency as defined in 16 Del.C. §1102(7) if the resident is an individual with a developmental disability or mental illness;

3.3.3 Record the reasons in the resident's clinical record; and

3.3.4 Include in the notice the items described in subsection 3.5 of this regulation.

3.4 Timing of the notice.

3.4.1 Except as specified in subsections 3.4.2 and 3.8 of this regulation, the notice of transfer or discharge required in subsection 3.3 of this regulation must be made by the facility at least 30 days before the resident is transferred or discharged.

3.4.2 Notice may be made as soon as practicable before transfer or discharge when:

3.4.2.1 The safety of individuals in the facility would be endangered in subsection 3.1.3 of this regulation;

3.4.2.2 The health of individuals in the facility would be endangered, in subsection 3.1.4 of this regulation;

3.4.2.3 The resident's health improves sufficiently to allow a more immediate transfer or discharge, in subsection 3.1.2 of this regulation; or

3.4.2.4 An immediate transfer or discharge is required by the resident's urgent medical needs in subsection 3.1.1 of this regulation.

3.5 Contents of the notice. The written notice specified in subsection 3.3 of this regulation must include the following:

3.5.1 A detailed individualized explanation of the reason or reasons for the action being taken which includes, in terms understandable to the resident:

3.5.1.1 A statement of what action the agency intends to take;

3.5.1.2 The reasons for the intended action, including any information needed for the resident to determine from the notice alone the accuracy of the facility’s intended action. When the reason is non-payment, an itemized statement of the resident’s account for the preceding 12 months; and

3.5.1.3 The specific policy or regulation supporting such action.

3.5.2 The effective date of transfer or discharge;

3.5.3 The location to which the resident will be transferred or discharged;

3.5.4 A statement of the resident’s right to a fair hearing as provided in this section;

3.5.5 The method by which the resident may request a fair hearing;

3.5.6 A statement that the resident may represent him or herself or may be represented by counsel or by another person; and

3.5.7 The name, address and telephone number of the State LTC Ombudsman;

3.6 Orientation for transfer or discharge. A facility must provide sufficient preparation and orientation to residents to ensure safe and orderly transfer or discharge from the facility.

3.7 Notice in advance of facility closure. In the case of facility closure, the individual who is the administrator of the facility must provide written notification prior to the impending closure to the Secretary, the State LTC Ombudsman, residents of the facility, and the legal representatives of the residents or other responsible parties, as well as the plan for the transfer and adequate relocation of the residents, as required at 42 CFR §483.75(r).

3.8 Room changes in a composite distinct part. Room changes in a facility that is a composite distinct part (as defined in 42 CFR §483.5(c)) must be limited to moves within the particular building in which the resident resides, unless the resident voluntarily agrees to move to another of the composite distinct part's locations. A facility’s discretion to transfer residents to another room is limited by 16 Del.C. §1121(b)(34).

3.9 Notice of bed-hold policy and readmission.

3.9.1 Notice before transfer. Before a nursing facility transfers a resident to a hospital or allows a resident to go on therapeutic leave, the nursing facility must provide written information to the resident and a family member or legal representative that specifies;

3.9.1.1 Notice of State bed-hold. The duration of the bed-hold policy under the State plan, if any during which the resident is permitted to return and resume residence in the nursing facility, See DHSS Long Term Care Institutional Provider Specific Policy Manual at Section 4.5; and

3.9.1.2 Facility policies. The nursing facility's policies regarding bed-hold periods, which must be consistent with subsection 3.9.3 of this regulation, permitting a resident to return.

3.9.2 Bed-hold notice upon transfer. At the time of transfer of a resident for hospitalization or therapeutic leave, a nursing facility must provide to the resident and a family member or legal representative written notice which explains the bed-hold policy described in subsection 3.9.1.1 of this regulation.

3.9.3 Permitting resident to return to facility. A nursing facility must establish and follow a written policy under which a resident, whose hospitalization or therapeutic leave exceeds the bed-hold period under the State plan, is readmitted to the facility immediately upon the first availability of a bed in a semi-private room if the resident:

3.9.3.1 Requires the services provided by the facility; and

3.9.3.2 Is eligible for Medicaid nursing facility services.

3.9.3.3 Additional protection for readmission is found at 16 Del.C. §1127(h).

3.10 Readmission to a composite distinct part. When the nursing facility to which a resident is readmitted is a composite distinct part (as defined in 42 CFR§483.5(c)), the resident must be permitted to return to an available bed in the particular location of the composite distinct part in which he or she resided previously. If a bed is not available in that location at the time of readmission, the resident must be given the option to return to that location upon the first availability of a bed there.

**History**
- *24 DE Reg. 275 (09/01/20)*
- *24 DE Reg. 275 (09/01/20)*
- *24 DE Reg. 275 (09/01/20)*
- *24 DE Reg. 275 (09/01/20)*
- *16 DE Reg. 296 (09/01/12)*
- *24 DE Reg. 275 (09/01/20)*

##### **16 Del. Admin. Code § 3102-4.0** Transfer, discharge and readmission rights of residents of a Long-Term Care Facility as defined in 16 Del.C. §1102(b)(4). See 16 Del.C. §1127. {#sec-3102-4.0 omnilex-key=us-de-regs-official--title-16--3102-4.0}

4.1 “Transfer and discharge” includes movement of a resident to a location outside of the licensed facility.

4.2 Transfer and discharge requirements. The facility must permit each resident to remain in the facility, and not transfer or discharge the resident from the facility except for:

4.2.1 Medical needs which cannot be met in the facility;

4.2.2 The resident's own welfare;

4.2.3 The welfare of the other individuals in the facility;

4.2.4 Nonpayment of justified charges, after appropriate notice; or

4.2.5 Termination of facility operation.

4.3 Documentation. When the facility transfers or discharges a resident under any of the circumstances specified in subsection 4.2.1 or 4.2.2 of this regulation, the resident's clinical record must be documented. The documentation must be made by:

4.3.1 The resident's physician when transfer or discharge is necessary in subsection 4.2.1 or 4.2.2 of this regulation; and

4.3.2 A physician when transfer or discharge is necessary in subsection 4.2.3 of this regulation.

4.4 Notice before transfer. Before a facility transfers or discharges a resident, the facility must:

4.4.1 Notify the resident and, if known, a family member or legal representative, of the resident of the transfer or discharge and the reasons for the move in writing and in a language and manner they understand.

4.4.2 Record the reasons in the resident's clinical record; and

4.4.3 Include in the notice the items described in subsection 4.6 of this regulation.

4.5 Timing of the notice. Except as specified in subsections 4.5.1 and 4.9 of this regulation, the notice of transfer or discharge required in subsection 4.4 of this regulation must be made by the facility at least 30 days before the resident is transferred or discharged.

4.5.1 Notice may be made as soon as practicable before or after transfer or discharge when:

4.5.1.1 The welfare of individuals in the facility would be endangered in subsection 4.2.3 of this regulation; or

4.5.1.2 An immediate transfer or discharge is required by the resident's urgent medical needs, in subsection 4.2.1 of this regulation;

4.6 Contents of the notice. The written notice specified in subsection 4.4 of this regulation must include the following:

4.6.1 The reason for transfer or discharge. A detailed individualized explanation of the reason or reasons for the action being taken which includes, in terms understandable to the resident:

4.6.1.1 A statement of what action the agency intends to take;

4.6.1.2 The reasons for the intended action, including any information needed for the resident to determine from the notice alone the accuracy of the facilities intended action. When the reason is non-payment, an itemized statement of the resident’s account for the preceding 12 months; and

4.6.1.3 The specific policy or regulation supporting such action.

4.6.2 The effective date of transfer or discharge;

4.6.3 The location to which the resident will be transferred or discharged;

4.6.4 A statement of the resident’s right to a fair hearing as provided in this section:

4.6.4.1 The method by which the resident may request a fair hearing; and

4.6.4.2 A statement that the resident may represent him or herself or may be represented by counsel or by another person.

4.6.5 The name, address and telephone number of the State LTC Ombudsman; and

4.6.6 For nursing facility residents with a developmental disability or mental illness, the mailing address and telephone number of the Delaware protection and advocacy agency as defined in 16 Del.C. §1102(7).

4.7 Orientation for transfer or discharge. A facility must provide sufficient preparation and orientation to residents to ensure safe and orderly transfer or discharge from the facility.

4.8 Notice in advance of facility closure. In the case of facility closure, the individual who is the administrator of the facility must provide written notification prior to the impending closure to Division, the State LTC Ombudsman, residents of the facility, and the legal representatives of the residents or other responsible parties, as well as the plan for the transfer and adequate relocation of the residents. The notice shall be provided as far in advance of closure as possible.

4.9 Room changes.

4.9.1 Room changes in a facility must be limited to moves within the particular building in which the resident resides, unless the resident voluntarily agrees to move to another location. A facility’s discretion to transfer residents to another room is limited by 16 Del.C. §1121(b)(34).

4.9.2 The facility must give reasonable notice before the resident’s room or roommate is changed, except in emergencies.

4.9.3 The facility shall endeavor to honor roommate requests whenever possible.

4.10 Notice of bed-hold policy and readmission.

4.10.1 Notice before transfer. When a nursing facility transfers a resident out of a facility to an acute care facility it must provide written information to the resident and a family member or legal representative that specifies that the facility must accept the patient or resident back into the facility when the resident no longer needs acute care and there is space available in the facility. If no space is available, the resident shall be accepted into the next available bed.

4.10.2 Permitting resident to return to facility. A nursing facility must establish and follow a written policy for implementing its obligation to immediately offer the first available bed to a resident who is entitled to be readmitted to the facility when acute care is no longer required.

**History**
- *24 DE Reg. 275 (09/01/20)*
- *24 DE Reg. 275 (09/01/20)*
- *24 DE Reg. 275 (09/01/20)*
- *24 DE Reg. 275 (09/01/20)*
- *16 DE Reg. 296 (09/01/12)*
- *24 DE Reg. 275 (09/01/20)*

##### **16 Del. Admin. Code § 3102-5.0** Fair Hearing Practice and Procedures which pertain to grievances in either Section 3.0 or 4.0 of this regulation. {#sec-3102-5.0 omnilex-key=us-de-regs-official--title-16--3102-5.0}

5.1 Right to hearing. An impartial hearing may be requested by a resident who believes a facility has erroneously determined that he or she must be transferred or discharged.

5.1.1 The hearing request must:

5.1.1.1 Be in writing;

5.1.1.2 Be received by the facility within 30 days from the date that the discharge notice is received by the resident or the resident’s legal representative; and

5.1.1.3 Be copied to the Division and the State LTC Ombudsman.

5.2 DHSS may deny or dismiss a request for a hearing if:

5.2.1 The resident withdraws the request in writing; or

5.2.2 The resident or his or her legal representative fails to appear at a scheduled hearing without good cause.

5.3 Impartial hearing must be conducted:

5.3.1 At a reasonable time, date and place;

5.3.2 After adequate written notice of the hearing;

5.3.3 By an impartial fact-finder who has not been directly involved in the initial determination of the action in question; and

5.3.4 With appropriate translation services available to parties or witnesses as needed to be provided at State expense.

5.4 If the hearing involves medical issues as the basis for the transfer or discharge and if the impartial fact finder considers it necessary to have a medical assessment other than that of the facility involved in making the transfer or discharge decision, such a medical assessment must be obtained at State expense and made part of the record.

5.5 Procedural rights. The parties must be given the opportunity to:

5.5.1 Examine at a reasonable time before the date of the hearing and during the hearing all documents and records to be used by either party at the hearing;

5.5.2 Bring witnesses;

5.5.3 Establish all pertinent facts and circumstances;

5.5.4 Present an argument without undue interference; and

5.5.5 Question or refute any testimony or evidence, including the opportunity to confront and cross-examine adverse witnesses.

5.5.6 Exercise additional rights for residents within the scope of Section 3.0, as provided in 42 CFR §483.10(b)(2). All residents have additional rights under 16 Del.C. §1121(b)(21).

5.6 Hearing decisions must be based exclusively on evidence introduced at the hearing.

5.7 The record must consist only of:

5.7.1 The transcript or recording of testimony and exhibits;

5.7.2 All papers and requests filed in the proceeding; and

5.7.3 The decision of the hearing officer.

5.8 The parties must have the access to the record at a convenient place and time in order to review or to secure a transcript at the party’s expense.

5.9 The impartial decision must:

5.9.1 Summarize the facts;

5.9.2 Identify the statutes or regulations pertinent to the decision;

5.9.3 Specify the reasons for the decisions; and

5.9.4 Identify the supporting evidence and apply the relevant legal principles.

5.10 The impartial fact-finder must:

5.10.1 Notify the parties of the decision, in writing.

5.10.2 Notify the parties that this is the final decision of DHSS with the right to an appeal pursuant to the Administrative Procedures Act, Title 29, Chapter 101.

**History**
- *24 DE Reg. 275 (09/01/20)*
- *24 DE Reg. 275 (09/01/20)*
- *24 DE Reg. 275 (09/01/20)*
- *24 DE Reg. 275 (09/01/20)*
- *16 DE Reg. 296 (09/01/12)*
- *24 DE Reg. 275 (09/01/20)*

#### **3105** Criminal History and Drug Testing For Nursing and Similar Facilities

##### **16 Del. Admin. Code § 3105-1.0** Legal Basis {#sec-3105-1.0 omnilex-key=us-de-regs-official--title-16--3105-1.0}

The legal basis for these regulations is 16 Del.C. §§1141 and 1142 and 29 Del.C. §7972.

**History**
- *13 DE Reg. 1308 (04/01/10)*
- *16 DE Reg. 974 (03/01/13)*

##### **16 Del. Admin. Code § 3105-2.0** Purpose {#sec-3105-2.0 omnilex-key=us-de-regs-official--title-16--3105-2.0}

The overall purpose of these regulations is to ensure the safety and well-being of residents of facilities licensed pursuant to 16 Del.C., Ch 11. To that end, persons selected for employment in facilities will be subject to pre-employment background checks and pre-employment drug testing.

**History**
- *13 DE Reg. 1308 (04/01/10)*
- *16 DE Reg. 974 (03/01/13)*

##### **16 Del. Admin. Code § 3105-3.0** Definitions {#sec-3105-3.0 omnilex-key=us-de-regs-official--title-16--3105-3.0}

“Applicant” is a person seeking employment in a facility as defined below; a current employee of a facility who seeks a promotion in the facility; a self-employed person or a person employed by an agency for work in a facility; a current employee, regardless of when hired, who the Department has a reasonable basis to suspect has been arrested for a disqualifying crime since becoming employed or commencing work; a former employee who consents prior to leaving employment to periodic review of his or her criminal background for a fixed time period. See 16 Del.C. 1141.

“Background Check Center (BCC)” means the electronic system which combines data streams from various sources within and outside the State in order to assist an employer in determining the suitability of a person for employment in a nursing facility or similar facility, or home care agency as those terms are defined in the enabling statute. See 29 Del.C. §7972.

“BCC disclosures” means the data on an Applicant that is generated by the BCC system.

“BCC consent form” means the form provided by DHSS which informs the Applicant of the scope of the BCC, the Applicant’s legal obligations, and the legal sanctions for failure to provide complete and accurate information.

“Criminal background check (CBC)”: The process conducted by the State Bureau of Identification of using an individual’s fingerprints to identify the person and to conduct both a State and a federal criminal background check.

“Criminal History” means a report from DLTCRP regarding its review of the Applicant’s entire federal criminal history from the Federal Bureau of Investigation, pursuant to Public Law 92-544 and amended (28U.S.C. § 534) and his or her Delaware record from the State Bureau of Identification. The Criminal History shall not include arrests that did not result in a conviction. It shall be limited to convictions and arrests for which no disposition is available.

“Delaware Health Information Network (DHIN)” means the State’s sanctioned provider of health information exchange services. 16 Del.C. Ch. 103

“Department” or “DHSS” means the Department of Health and Social Services. DHSS owns and operates the BCC.

“Delaware Judicial Information System (DELJIS)” means the agency which maintains all records of criminal arrests and convictions in the State of Delaware.

“Division” or “DLTCRP” means the Division of Long Term Care Residents Protection, Department of Health and Social Services. The Division is responsible for background checks for licensed facilities.

“Facility” means a nursing facility or similar facility licensed pursuant to 16 Del.C. Ch. 11.

“Grandfathered employee” is a current employee who was employed by a facility prior to March 31, 1999, and thus was exempted from the requirement enacted at that time that all facility employees have a criminal background check.

“Grandfathered employee consent form” is a consent form to be used for Grandfathered employees who are not subject to the entire review process of the BCC, and thus need consent only to the assignment of an SBI number, which may involve providing fingerprints at SBI. All Grandfathered persons must be on the BCC Master List within 120 days from commencement of the BCC system.

“Individualized Assessment” is the process of evaluating the suitability of an individual with a criminal history for employment.

“Master List” is the list maintained by the BCC for each employer. The list contains the names of all persons who:

“Master List retention form” means the form provided by DHSS which an employee whose employment is terminating may choose to execute in order to stay on the Master List for up to 3 years post-fingerprinting in order to facilitate re-employment.

“Rap-back” is the process of continuous monitoring an employee’s arrest and conviction record through DELJIS. The process is limited to Delaware arrests and convictions.

“SBI” means the State Bureau of Identification. It is the agency which processes all criminal background checks in the State of Delaware.

“Service Letter” means a letter containing specific information about a prospective employee’s prior employment. Service Letters are a statutory requirement found at 19 Del.C. §708.

**History**
- *13 DE Reg. 1308 (04/01/10)*
- *16 DE Reg. 974 (03/01/13)*

##### **16 Del. Admin. Code § 3105-4.0** Persons Subject to the Law {#sec-3105-4.0 omnilex-key=us-de-regs-official--title-16--3105-4.0}

4.1 All persons working in facilities are required to be on the Master List of the BCC. New Applicants must be processed through the BCC and will automatically be placed on the Master List if hired. Current employees, whether grandfathered or not, must be added to the Master List through the process directed by DLTCRP.

4.2 No employer is permitted to continue to employ a grandfathered employee who has not been assigned an SBI number (through fingerprinting or retrieval by DLTCRP of an SBI# previously assigned) and entered into the BCC within 120 days from the date of BCC implementation.

4.3 Non-grandfathered current employees must be entered into the BCC by September 30, 2013

**History**
- *13 DE Reg. 1308 (04/01/10)*
- *16 DE Reg. 974 (03/01/13)*

##### **16 Del. Admin. Code § 3105-5.0** Rap-back {#sec-3105-5.0 omnilex-key=us-de-regs-official--title-16--3105-5.0}

5.1 The BCC Rap back is designed to accomplish two objectives:

5.1.1 To provide the employer with refreshed information related to the criminal convictions of an employee in order to ensure the safety of the residents served and;

5.1.2 To reduce the frequency of criminal background checks by maintaining current information regarding each employee’s criminal record, avoiding the need to repeat the processing of criminal histories.

5.2 The BCC automatically conducts a Rap-back on all employees listed on the Master List. The Rap-back process will provide DLTCRP with information regarding any new arrest or conviction in the state. DLTCRP will determine, at its discretion and depending of the nature of the alleged crime, whether or not to inform the employer of the arrest. DLTCRP will monitor the charge until there is a disposition. When the disposition is known, DLTCRP will inform the Employer of the outcome.

5.3 The Rap-back does not include convictions reported through the FBI. In order to capture that information, a person who is an Applicant is subject to a criminal background check if the previous check is 3 years old or older.

6.0 Consent forms

6.1 An employee must execute a BCC consent form as a condition of employment. The consent ends when the employment ends unless the employee choses to extend the consent to expedite rehire by avoiding the need for repeat fingerprinting if last fingerprinted within 3 years.

6.2 An employee whose employment is terminating may, at the time of separation, execute a Master List retention form in order to remain on the Master List of the BCC. The consent period is 3 years from the date last fingerprinted, less the intervening time. E.g. A person fingerprinted on June 1 of year X; can consent to remain on the Master List until May 30 of year x+3 [June 1, 2013 to May 30, 2016]. Consent cannot extend beyond 3 years from the date last fingerprinted.

6.3 The original Grandfathered employee consent form shall accompany the employee to SBI for fingerprinting if so directed by DLTCRP because an SBI# is not already known by DLTCRP due to prior fingerprinting. A copy of the Grandfathered employee consent form shall be maintained in a discrete file which is readily accessible, without delay, upon request by an agent of DLTCRP.

6.4 A copy of the BCC consent form executed by an Applicant for employment and a copy of the Master List Retention form executed by an employee who seeks to continue inclusion on the Master List pursuant to 6.2 above shall be maintained in separate discrete files which are readily accessible, without delay, upon request by an agent of DLTCRP.

**History**
- *13 DE Reg. 1308 (04/01/10)*
- *16 DE Reg. 974 (03/01/13)*

##### **16 Del. Admin. Code § 3105-7.0** Service Letters {#sec-3105-7.0 omnilex-key=us-de-regs-official--title-16--3105-7.0}

7.1 Before hiring an Applicant, employers are generally required by law to obtain from prior employers and to provide to prospective employers Service Letters which provide specific information as required by the Department of Labor. 19 Del.C. §708.

7.2 When an employee hired after the effective date of the BCC is terminated, the employer shall promptly complete a Service Letter which will be stored by the BCC and available to the next prospective employer. The Service Letter shall expire after 5 years.

**History**
- *13 DE Reg. 1308 (04/01/10)*
- *16 DE Reg. 974 (03/01/13)*

##### **16 Del. Admin. Code § 3105-8.0** Criminal History {#sec-3105-8.0 omnilex-key=us-de-regs-official--title-16--3105-8.0}

8.1 The SBI is authorized to furnish information pertaining to the identification and conviction data for any person to employers or prospective employers so long as the information is used solely for purposes of making an employment decision. 11 Del.C. 8513(c) and(c)(1).

8.2 Disqualifying convictions. No facility shall employ a person who has, within the past 15 years, been convicted of abusing, neglecting or mistreating a resident of a facility, or an adult who is impaired. See 11 Del.C. 8564 and 42 CFR §483.13(c)(1)(ii).

8.3 DHSS adopts the guidance from the Equal Employment Opportunity Commission, Consideration of Arrest and Conviction Records in Employment Decisions Under Title VII of the Civil Rights Act of 1964, 915.002, issued 4/25/2012

8.4 Notification of Criminal History review - If the Criminal History review reveals no criminal history, DLTCRP has no duty to inform the Applicant. If a criminal history is revealed, DLTCRP shall inform the Applicant by United States Mail, or in whatever alternate method the Applicant requests, such as e-mail or text message.

**History**
- *13 DE Reg. 1308 (04/01/10)*
- *16 DE Reg. 974 (03/01/13)*

##### **16 Del. Admin. Code § 3105-9.0** Drug Tests {#sec-3105-9.0 omnilex-key=us-de-regs-official--title-16--3105-9.0}

9.1 The BCC provides an electronic conduit through the Delaware Health Information Network (DHIN) to transmit the results of a drug test from a DHIN participating laboratory to the employer. An employer that chooses not to engage a DHIN-participating laboratory will certify that a drug test has been secured by checking a box in the BCC. If the box is checked, it constitutes a representation that a drug test which complies with statutory requirements, 11 Del.C. 1142, has been secured prior to hiring.

9.2 Evidence of all drug tests not transmitted through the BCC which have been represented to have been secured must be maintained in a discrete file and be available for inspection, without delay, upon request from an agent of DLTCRP.

10.0 Further Facility/Employer Responsibilities

10.1 An employer whose facility includes both licensed and unlicensed areas must ensure that all persons who perform services in the licensed areas comply with the law.

10.2 The employer shall ensure that every application for employment at a facility executes the BCC consent form.

10.3 The employer shall ensure that copies of all BCC consent forms signed by Applicants are maintained in a discrete file which is immediately available, upon request, from any agent of DLTCRP.

10.4 The employer must ensure that no Applicant is employed without first receiving the results of the Applicant’s mandatory drug test.

10.5 The employer must maintain an accurate BCC Master List by promptly reflecting the termination of any person no longer working in the facility.

10.6 An employee whose employment is terminated may remain on the Master List to facilitate reemployment by the same or another facility up to 3 years beyond the date the individual was last fingerprinted. See 6.2 above. When that date is reached the employee will automatically be removed from the Master List without further action by the employer.

10.7 An Applicant who is entered into the BCC whose employment status (withdrawn, hired) is not completed by the employer within 30 days will be dropped from the BCC system.

10.8 The employer is prohibited from sharing BCC disclosure information with any other person, employer or agency.

10.9 The employer shall use the BCC disclosures solely for the purpose of determining the suitability of an Applicant for employment.

**History**
- *13 DE Reg. 1308 (04/01/10)*
- *16 DE Reg. 974 (03/01/13)*

##### **16 Del. Admin. Code § 3105-11.0** Responsibilities of non-facility employers who are within the scope of the BCC. {#sec-3105-11.0 omnilex-key=us-de-regs-official--title-16--3105-11.0}

Any non-facility employer working or providing workers to a facility is subject to the following requirements:

11.1 All the requirements listed in Section 10 above.

11.2 The obligation to provide BCC disclosures to any facility or individual who will be receiving the services of the employee.

**History**
- *13 DE Reg. 1308 (04/01/10)*
- *16 DE Reg. 974 (03/01/13)*

##### **16 Del. Admin. Code § 3105-12.0** Confidentiality {#sec-3105-12.0 omnilex-key=us-de-regs-official--title-16--3105-12.0}

12.1 DHSS shall store written and electronically-recorded BCC disclosures in a secure manner, to provide for the confidentiality of records and to protect against any possible threats to the security or integrity of the information.

12.2 DHSS shall limit the use of BCC disclosures to the sole objective of assisting employers determining the suitability of an Applicant for employment.

12.3 DHSS shall not release to employers copies of actual electronic reports of criminal history records prepared by the Federal Bureau of Investigation.

12.4 The BCC is designed to allow participants to put information regarding their facility or organization on a dedicated page titled “Employment Information”. The page was designed to provide an additional resource to the public, and to provide a vehicle for the posting of available employment opportunities. DHSS retains the authority to block or edit material placed on the BCC which it deems false, misleading, or otherwise inappropriate.

12.5 The following procedure shall be established to permit the review of personal BCC disclosures by an Applicant:

12.5.1 An Applicant shall submit a request in writing to the Department for an on-site review of his BCC disclosures.

12.5.2 DLTCRP shall schedule an appointment at a mutually convenient time to enable the Applicant to review the BCC disclosures. Photo identification will be required at the time of the appointment.

12.5.3 The BCC disclosures shall be reviewed in the presence of a DLTCRP employee.

12.5.4 Written documentation of the date and time of the review and the names of those present shall be maintained by DLTCRP.

12.5.5 DLTCRP shall assist the Applicant who wishes to challenge the BCC disclosures by providing information about the source of the data and the way to pursue an appeal.

**History**
- *13 DE Reg. 1308 (04/01/10)*
- *16 DE Reg. 974 (03/01/13)*

#### **3110** Background Checks and Drug Testing for Home Care Agencies

##### **16 Del. Admin. Code § 3110-1.0** Legal Basis {#sec-3110-1.0 omnilex-key=us-de-regs-official--title-16--3110-1.0}

The legal basis for these regulations is 16 Del.C. §§1145 and 1146 and 29 Del.C. §7972.

**History**
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *6 DE Reg. 1208 (3/1/03)*
- *13 DE Reg. 1317 (04/01/10)*
- *16 DE Reg. 978 (03/01/13)*

##### **16 Del. Admin. Code § 3110-2.0** Purpose {#sec-3110-2.0 omnilex-key=us-de-regs-official--title-16--3110-2.0}

The overall purpose of these regulations is to ensure the safety and well-being of individuals in the care of home care agencies licensed pursuant to 16 Del.C., Ch 11. To that end, persons selected for employment will be subject to pre-employment background checks and pre-employment drug testing.

**History**
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *6 DE Reg. 1208 (3/1/03)*
- *13 DE Reg. 1317 (04/01/10)*
- *16 DE Reg. 978 (03/01/13)*

##### **16 Del. Admin. Code § 3110-3.0** Definitions {#sec-3110-3.0 omnilex-key=us-de-regs-official--title-16--3110-3.0}

“Agency” means all programs or home care agencies licensed pursuant to 16 Del.C. §122(3(m), or (3)(0), or (3)(x).

“Applicant” is a person seeking employment with an employer as defined in 16 Del.C. §1145(b)(1).

“Background Check Center (BCC)” means the electronic system which combines data streams from various sources within and outside the State in order to assist an employer in determining the suitability of a person for employment in a nursing facility or similar facility, or home care agency as those terms are defined in the enabling statute. See 29 Del.C. §7972.

“BCC disclosures” means the data on an Applicant that is collected and generated by the BCC system.

“BCC consent form” means the form provided by DHSS which informs the Applicant of the scope of the BCC, the Applicant’s legal obligations, and the legal sanctions for failure to provide complete and accurate information.

“Criminal background check (CBC)” means the process conducted by the State Bureau of Identification of using an individual’s fingerprints to identify the person and to conduct both a State and a federal criminal background check.

“Criminal History” means a report from DLTCRP regarding its review of the Applicant’s entire federal criminal history from the Federal Bureau of Investigation, pursuant to Public Law 92-544 and amended (28U.S.C. § 534) and his or her Delaware record from the State Bureau of Identification. The criminal history shall not include arrests that did not result in a conviction. It shall be limited to convictions and arrests for which no disposition is available.

“Delaware Health Information Network (DHIN)” means the State’s sanctioned provider of health information exchange services. 16 Del.C. Ch. 103

“Department” or “DHSS” means the Department of Health and Social Services. DHSS owns and operates the BCC.

“Delaware Judicial Information System (DELJIS)” means the agency which maintains all records of criminal arrests and convictions in the State of Delaware.

“Division” or “DLTCRP” means the Division of Long Term Care Residents Protection, Department of Health and Social Services. The Division is responsible for background checks for programs and home health agencies.

“Facility” means a nursing facility or similar facility licensed pursuant to 16 Del.C. Chapter 11.

“Grandfathered employee” is a current employee who was employed by an agency prior to July 1, 2001, and thus was exempted from the requirement enacted at that time that all agency employees have a criminal background check.

“Grandfathered employee consent form” is a consent form to be used for Grandfathered employees who are not subject to the entire review process of the BCC, and thus need consent only to the assignment of an SBI number, which may involve providing fingerprints at SBI. All Grandfathered persons must be on the BCC Master List within 120 days from commencement of the BCC system.

“Individualized Assessment” is the process of evaluating the suitability of an individual with a criminal history for employment.

“Master List” is the list maintained by the BCC for each employer. The list contains the names of all persons who:

“Master List retention form” means the form provided by DHSS which an employee whose employment is terminating may choose to execute in order to stay on the Master List for up to 3 years post-fingerprinting in order to facilitate re-employment.

“Rap-back” is the process of continuous monitoring an employee’s arrest and conviction record through DELJIS. The process is limited to Delaware arrests and convictions.

“SBI” means the State Bureau of Identification. It is the agency which processes all criminal background checks in the State of Delaware.

“Service Letter” means a letter containing specific information about a prospective employee’s prior employment. Service Letters are a statutory requirement found at 19 Del.C. §708.

**History**
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *6 DE Reg. 1208 (3/1/03)*
- *13 DE Reg. 1317 (04/01/10)*
- *16 DE Reg. 978 (03/01/13)*

##### **16 Del. Admin. Code § 3110-4.0** Persons Subject to the Law {#sec-3110-4.0 omnilex-key=us-de-regs-official--title-16--3110-4.0}

4.1 All persons working for agencies are required to be on the Master List of the BCC. New Applicants must be processed through the BCC and will automatically be placed on the Master List if hired. Current employees, whether grandfathered or not, must be added to the Master List through the process directed by DLTCRP.

4.2 No employer is permitted to continue to employ a grandfathered employee who has not been assigned an SBI number (through fingerprinting or retrieval by DLTCRP of an SBI number previously assigned) and entered into the BCC within 120 days from the date of BCC implementation.

4.3 Non-grandfathered current employees must be entered into the BCC by September 30, 2013.

**History**
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *6 DE Reg. 1208 (3/1/03)*
- *13 DE Reg. 1317 (04/01/10)*
- *16 DE Reg. 978 (03/01/13)*

##### **16 Del. Admin. Code § 3110-5.0** Rap-back {#sec-3110-5.0 omnilex-key=us-de-regs-official--title-16--3110-5.0}

5.1 The BCC Rap back is designed to accomplish two objectives:

5.1.1 To provide the employer with refreshed information related to the criminal convictions of an employee in order to ensure the safety of the individuals served and;

5.1.2 To reduce the frequency of criminal background checks by maintaining current information regarding each employee’s criminal record, avoiding the need to repeat the processing of criminal histories.

5.2 The BCC automatically conducts a Rap-back on all employees listed on the Master List. The Rap-back process will provide DLTCRP with information regarding any new arrest or conviction in the state. DLTCRP will determine, at its discretion and depending of the nature of the alleged crime, whether or not to inform the employer of the arrest. DLTCRP will monitor the charge until there is a disposition. When the disposition is known, DLTCRP will inform the Employer of the outcome.

5.3 The Rap-back does not include convictions reported through the FBI. In order to capture that information, a person who is an Applicant is subject to a criminal background check if the previous check is 3 years old or older.

**History**
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *6 DE Reg. 1208 (3/1/03)*
- *13 DE Reg. 1317 (04/01/10)*
- *16 DE Reg. 978 (03/01/13)*

##### **16 Del. Admin. Code § 3110-6.0** Consent forms {#sec-3110-6.0 omnilex-key=us-de-regs-official--title-16--3110-6.0}

6.1 An employee must execute a BCC consent form as a condition of employment. The consent ends when the employment ends unless the employee choses to extend the consent to expedite rehire by avoiding the need for repeat fingerprinting if last fingerprinted within 3 years.

6.2 An employee whose employment is terminating may, at the time of separation, execute a Master List retention form in order to remain on the Master List of the BCC. The consent period is 3 years from the date last fingerprinted, less the intervening time. E.g. A person fingerprinted on June 1 of year X; can consent to remain on the Master List until May 30 of year x+3 [June 1, 2013 to May 30, 2016]. Consent cannot extend beyond 3 years from the date last fingerprinted.

6.3 The original Grandfathered employee consent form shall accompany the employee to SBI for fingerprinting if so directed by DLTCRP because an SBI number is not already known by DLTCRP due to prior fingerprinting. A copy of the Grandfathered employee consent form shall be maintained in a discrete file which is readily accessible, without delay, upon request by an agent of DLTCRP.

6.4 A copy of the BCC consent form executed by an Applicant for employment and a copy of the Master List Retention form executed by an employee who seeks to continue inclusion on the Master List pursuant to 6.2 above shall be maintained in separate discrete files which are readily accessible, without delay, upon request by an agent of the Department.

**History**
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *6 DE Reg. 1208 (3/1/03)*
- *13 DE Reg. 1317 (04/01/10)*
- *16 DE Reg. 978 (03/01/13)*

##### **16 Del. Admin. Code § 3110-7.0** Service Letters {#sec-3110-7.0 omnilex-key=us-de-regs-official--title-16--3110-7.0}

7.1 Before hiring an Applicant, employers are required by law to obtain from prior employers and to provide to prospective employers Service Letters which provide specific information as required by the Department of Labor. 19 Del.C. §708.

7.2 When an employee hired after the effective date of the BCC is terminated, the employer shall promptly complete a Service Letter which will be stored by the BCC and available to the next prospective employer. The Service Letter shall expire after 5 years.

**History**
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *6 DE Reg. 1208 (3/1/03)*
- *13 DE Reg. 1317 (04/01/10)*
- *16 DE Reg. 978 (03/01/13)*

##### **16 Del. Admin. Code § 3110-8.0** Criminal History – {#sec-3110-8.0 omnilex-key=us-de-regs-official--title-16--3110-8.0}

8.1 The SBI is authorized to furnish information pertaining to the identification and conviction data for any person to employers or prospective employers so long as the information is used solely for purposes of making an employment decision. 11 Del.C. 8513(c) and(c)(1) or any theft-related misdemeanor conviction within the past 18 months, or theft-related felony within the past 10 years.

8.2 Disqualifying convictions. No agency shall employ a person who has, within the past 15 years, been convicted of abusing, neglecting or mistreating a resident of a facility, or an adult who is impaired, or of a theft-related misdemeanor within the past 2 years, or of a theft-related felony within the past 10 years. See 11 Del.C. 8564 and 42 CFR §483.13(c)(1)(ii).

8.3 DHSS adopts the guidance from the Equal Employment Opportunity Commission, Consideration of Arrest and Conviction Records in Employment Decisions Under Title VII of the Civil Rights Act of 1964, 915.002, issued 4/25/2012

8.4 Notification of Criminal History review - If the Criminal History review reveals no criminal history, DLTCRP has no duty to inform the Applicant. If a criminal history is revealed, DLTCRP shall inform the Applicant by United States Mail, or in whatever alternate method the Applicant requests, such as e-mail or text message.

**History**
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *6 DE Reg. 1208 (3/1/03)*
- *13 DE Reg. 1317 (04/01/10)*
- *16 DE Reg. 978 (03/01/13)*

##### **16 Del. Admin. Code § 3110-9.0** Drug Tests {#sec-3110-9.0 omnilex-key=us-de-regs-official--title-16--3110-9.0}

9.1 The BCC provides an electronic conduit through the Delaware Health Information Network (DHIN) to transmit the results of a drug test from a DHIN participating laboratory to the employer. An employer that chooses not to engage a DHIN-participating laboratory will certify that a drug test has been secured by checking a box in the BCC. If the box is checked, it constitutes a representation that a drug test which complies with statutory requirements, 11 Del.C. 1142, has been secured prior to hiring.

9.2 Evidence of all drug tests not transmitted through the BCC which have been represented to have been secured must be maintained in a discrete file and be available for inspection, without delay, upon request from an agent of DLTCRP.

**History**
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *6 DE Reg. 1208 (3/1/03)*
- *13 DE Reg. 1317 (04/01/10)*
- *16 DE Reg. 978 (03/01/13)*

##### **16 Del. Admin. Code § 3110-10.0** Further Employer Responsibilities {#sec-3110-10.0 omnilex-key=us-de-regs-official--title-16--3110-10.0}

10.1 An employer must ensure that all persons who perform services for the agency comply with the law.

10.2 The employer shall ensure that every application for employment executes the BCC consent form.

10.3 The employer shall ensure that copies of all BCC consent forms signed by Applicants are maintained in a discrete file which is immediately available, upon request, from any agent of the Department.

10.4 The employer must ensure that no Applicant is employed without first receiving the results of the Applicant’s mandatory drug test.

10.5 The employer must maintain an accurate Master List by promptly reflecting the termination of any person no longer working in the agency.

10.6 An employee whose employment is terminated may remain on the Master List to facilitate reemployment by the same or another agency up to 3 years beyond the date the individual was last fingerprinted. See 6.2 above. When that date is reached the employee will automatically be removed from the Master List without further action by the employer.

10.7 An Applicant who is entered into the BCC whose employment status (withdrawn, hired) is not completed by the employer within 30 days will be dropped from the BCC system.

10.8 The employer is prohibited from sharing BCC disclosure information with other person, agency, or facility except when requested because the subject of the BCC disclosure will be working for that employer in a facility or in the personal private residence of the requesting party.

10.9 The employer shall use the BCC disclosures solely for the purpose of determining the suitability of an Applicant for employment.

**History**
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *6 DE Reg. 1208 (3/1/03)*
- *13 DE Reg. 1317 (04/01/10)*
- *16 DE Reg. 978 (03/01/13)*

##### **16 Del. Admin. Code § 3110-11.0** Confidentiality {#sec-3110-11.0 omnilex-key=us-de-regs-official--title-16--3110-11.0}

11.1 DHSS shall store written and electronically-recorded BCC disclosures in a secure manner, to provide for the confidentiality of records and to protect against any possible threats to the security or integrity of the information.

11.2 DHSS shall limit the use of BCC disclosures to the sole objective of assisting employers determining the suitability of an Applicant for employment.

11.3 DHSS shall not release to employers copies of actual electronic reports of criminal history records prepared by the Federal Bureau of Investigation.

11.4 The BCC is designed to allow participants to put information regarding their agency or organization on a dedicated page titled “Employment Information”. The page was designed to provide an additional resource to the public, and to provide a vehicle for the posting of available employment opportunities. DHSS retains the authority to block or edit material placed on the BCC which it deems false, misleading, or otherwise inappropriate.

11.5 The following procedure shall be established to permit the review of personal BCC disclosures by an Applicant:

11.5.1 An Applicant shall submit a request in writing to the Department for an on-site review of his BCC disclosures.

11.5.2 DLTCRP shall schedule an appointment at a mutually convenient time to enable the Applicant to review the BCC disclosures. Photo identification will be required at the time of the appointment.

11.5.3 The BCC disclosures shall be reviewed in the presence of a DLTCRP employee.

11.5.4 Written documentation of the date and time of the review and the names of those present shall be maintained by DLTCRP.

11.5.5 DLTCRP shall assist the Applicant who wishes to challenge the BCC disclosures by providing information about the source of the data and the way to pursue an appeal.

**History**
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *16 DE Reg. 978 (03/01/13)*
- *6 DE Reg. 1208 (3/1/03)*
- *13 DE Reg. 1317 (04/01/10)*
- *16 DE Reg. 978 (03/01/13)*

#### **3201** Skilled and Intermediate Care Nursing Facilities

##### **16 Del. Admin. Code § 3201-1.0** Scope {#sec-3201-1.0 omnilex-key=us-de-regs-official--title-16--3201-1.0}

1.1 A Nursing facility (NF) is a residential institution, as defined in 16 Delaware Code, §1102(4), which provides services to residents which include resident beds, continuous nursing services, and health and treatment services for individuals who do not currently require continuous hospital care. Care is given in accordance with a physician's orders and requires the competence of a registered nurse (RN).

1.2 Nursing facilities shall be subject to all applicable local, state and federal code requirements. The provisions of 42 CFR Ch. IV Part 483, Subpart B, requirements for Long Term Care Facilities, and any amendments or modifications thereto, are hereby adopted as the regulatory requirements for skilled and intermediate care nursing facilities in Delaware. Subpart B of Part 483 is hereby referred to, and made part of this Regulation, as if fully set out herein. All applicable code requirements of the State Fire Prevention Commission are hereby adopted and incorporated by reference.

**History**
- *13 DE Reg. 1322 (04/01/10)*
- *13 DE Reg. 1322 (04/01/10)*
- *24 DE Reg. 574 (12/01/20)*
- *14 DE Reg. 1360 (06/01/11)*
- *13 DE Reg. 1322 (04/01/10)*
- *15 DE Reg. 192 (08/01/11)*
- *24 DE Reg. 574 (12/01/20)*
- *13 DE Reg. 1322 (04/01/10)*
- *15 DE Reg. 79 (07/01/11)*
- *24 DE Reg. 574 (12/01/20)*
- *25 DE Reg. 759 (02/01/22)*
- *13 DE Reg. 1322 (04/01/10)*
- *16 DE Reg. 861 (02/01/13)*
- *24 DE Reg. 574 (12/01/20)*
- *13 DE Reg. 1322 (04/01/10)*
- *13 DE Reg. 1322 (04/01/10)*
- *12 DE Reg. 960 (01/01/09)*
- *13 DE Reg. 1322 (04/01/10)*
- *16 DE Reg. 861 (02/01/13)*
- *24 DE Reg. 574 (12/01/20)*
- *25 DE Reg. 759 (02/01/22)*

##### **16 Del. Admin. Code § 3201-2.0** Definitions {#sec-3201-2.0 omnilex-key=us-de-regs-official--title-16--3201-2.0}

2.1 Activities of Daily Living (ADLs) - Normal daily activities including but not limited to ambulating, transferring, range of motion, grooming, bathing, dressing, eating and toileting.

2.2 Advance Directive - Written instructions such as a living will or durable power of attorney for health care, in accordance with 16 Delaware Code, Chapter 25, relating to the provision of health care should the individual become incapacitated.

2.3 Associated Entity - The partially or wholly owned subsidiary, parent company or partner of the applicant for licensure or any other entity identified on the corporation formation documents.

2.4 Department/DHSS - Department of Health and Social Services

2.5 Division - Division of Long Term Care Residents Protection

2.6 Extensive Remodeling - Renovations or alterations within the facility that modify the square footage of any room intended for resident use.

2.7 Food Service Manager -

2.7.1 For facilities subject to 16 Delaware Code, §1164, an individual who meets the statutory requirements for a food service manager. A facility may seek a waiver of the statutory requirements if an insufficient pool of applicants exists. The facility must demonstrate the inability to hire a person who meets the requirements after a recruitment process of at least 90 days duration that included advertising in at least two newspapers of general circulation and one trade journal, offering a competitive salary. If those conditions are met, the Division may waive the education requirement for an applicant who meets the requirements of a "person in charge" as defined in the current Delaware Food Code.

2.7.2 For facilities not subject to 16 Delaware Code, §1164, an individual who, at a minimum, meets the requirements of a "person in charge" as defined in the current Delaware Food Code.

2.8 Full-time - Forty hours per week or the standard workweek established by the facility.

2.9 Incident - An occurrence or event, a record of which must be maintained in facility files, which includes all reportable incidents and the additional occurrences or events listed in Section 9.7 of these regulations.

2.10 Nursing Home Administrator - A licensee of the Delaware Board of Examiners of Nursing Home Administrators who manages the facility on a full-time basis, and is responsible for the delivery quality care to its residents and for the implementation of the policies and procedures of the facility.

2.11 Nursing Services - Those curative, restorative, preventive or palliative health care services provided by certified nursing assistants, licensed practical nurses and registered nurses to assist a resident to attain or maintain his or her highest practicable physical, mental, and psychosocial well-being as determined by the resident's assessment and individual care plan.

2.12 Pediatric resident - A person residing in a nursing facility who is under 18 years of age and for who there is a care plan including medical care, treatment and other related services in accordance with the Regulations for Nursing Homes Admitting Pediatric Residents.

2.13 Physician - A medical doctor or doctor of osteopathy licensed to practice medicine in the State of Delaware.

2.14 Rehabilitation - The actions and services such as physical therapy, occupational therapy, speech therapy and psychosocial services provided or required to restore an ill or injured person to self-sufficiency at his or her highest attainable level.

2.15 Reportable Incident - An occurrence or event which must be reported immediately to the Division and for which there is reasonable cause to believe that a resident has been abused, neglected, mistreated or subjected to financial exploitation/misappropriation of their property as those terms are defined in 16 Delaware Code, §1131 and/or 42 CFR 483.13(c). Reportable incident also includes an occurrence or event listed in Section 9.8 of these regulations.

2.16 Resident - A person admitted to a nursing facility because of illness or impairment, under a physician's care, for whom there is planned continuing health care directed toward improvement in health or for whom palliative medical and nursing measures are required.

2.17 Restraint - A physical or chemical means of restricting or controlling a resident. Specifically, a mechanical device, material or equipment attached or adjacent to a resident's body that the resident cannot remove easily, and which restricts freedom of movement or normal access to the resident's body.

2.18 Satisfactory Compliance History - A sworn affidavit, as required by 16 Delaware Code, §1104(d), attesting to a licensure applicant's provision of quality care in a nursing facility, during the five years preceding the initial application, as determined by the absence of the following:

2.18.1 Termination or denial of participation in the Medicare or Medicaid program

2.18.2 State licensure revocation

2.18.3 Financial insolvency

2.18.4 Outstanding civil actions for debt

2.18.5 Outstanding civil money penalty

2.19 Social worker - For facilities subject to 16 Delaware Code, §1165, with at least 100 beds, an individual with a bachelor's degree in social work, or a bachelor's degree in a human services field including, but not limited to, sociology, special education, rehabilitation counseling, and psychology; and one year of supervised social work experience in a health care setting working directly with individuals. For facilities with fewer than 100 beds, the facility may designate the director of admissions or a nurse to assume the duties of the social worker.

2.20 Supervision - The oversight and direction of personnel necessary to ensure the safety, comfort and well-being of residents.

2.21 Vendor – Any individual who is not employed by the facility but provides direct services to one or more facility residents.

**History**
- *13 DE Reg. 1322 (04/01/10)*
- *13 DE Reg. 1322 (04/01/10)*
- *24 DE Reg. 574 (12/01/20)*
- *14 DE Reg. 1360 (06/01/11)*
- *13 DE Reg. 1322 (04/01/10)*
- *15 DE Reg. 192 (08/01/11)*
- *24 DE Reg. 574 (12/01/20)*
- *13 DE Reg. 1322 (04/01/10)*
- *15 DE Reg. 79 (07/01/11)*
- *24 DE Reg. 574 (12/01/20)*
- *25 DE Reg. 759 (02/01/22)*
- *13 DE Reg. 1322 (04/01/10)*
- *16 DE Reg. 861 (02/01/13)*
- *24 DE Reg. 574 (12/01/20)*
- *13 DE Reg. 1322 (04/01/10)*
- *13 DE Reg. 1322 (04/01/10)*
- *12 DE Reg. 960 (01/01/09)*
- *13 DE Reg. 1322 (04/01/10)*
- *16 DE Reg. 861 (02/01/13)*
- *24 DE Reg. 574 (12/01/20)*
- *25 DE Reg. 759 (02/01/22)*

##### **16 Del. Admin. Code § 3201-3.0** General Requirements {#sec-3201-3.0 omnilex-key=us-de-regs-official--title-16--3201-3.0}

3.1 The term "nursing home" or "nursing facility" shall not be used as part of the name of any facility in this State unless it has been so licensed by the Division.

3.2 Each nursing facility shall develop written policies pertaining to the services provided.

3.3 A nursing facility shall not adopt any policy which conflicts with applicable statutes or regulations.

3.4 Inspections and monitoring by the Division shall be carried out in accordance with 16 Delaware Code, §1107.

3.5 Upon receipt of a report of any violation(s) of these regulations, the facility shall submit a written plan of action to correct cited deficiencies within 10 working days or such other time period as may be specified. The plan of action shall address corrective actions and include all measures and completion dates to prevent their recurrence as follows:

3.5.1 How the corrective action will be accomplished for a resident(s) affected by the deficient practice;

3.5.2 How the facility will identify other residents having the potential to be affected by the same deficient practice;

3.5.3 What measures or systemic changes will be put in place to ensure that the deficient practice will not recur;

3.5.4 What program will be put into place to monitor the continued effectiveness of the corrective actions.

3.6 The Division shall be notified, in writing, upon any changes in the administrator, assistant administrator or director of nursing positions.

3.7 The nursing facility shall comply with 42 CFR 483.10, 483.12, 483.13, 483.15 and/or 16 Delaware Code, §1121 regarding the rights of residents. Those rights shall be made available in writing to residents, guardians, representatives or next of kin.

3.8 Each facility shall provide, in writing, the refund and prepayment policy at the time of admission, and in the case of residents admitted while awaiting approval of third-party payment, an exact statement of responsibility in the event of retroactive denial. The facility shall notify residents, in writing, at least 30 days prior to a rate increase.

3.9 A facility may require an individual who has legal access to a resident's income or resources available to pay for facility care to sign a contract to provide for facility payment from the resident's income or resources. However, in doing so, the facility shall not require a third party to incur personal financial liability for the nursing facility expenses.

3.10 The nursing facility shall cooperate fully with the state protection and advocacy agency, as defined in 16 Del.C. §1102(7), in fulfilling functions authorized by Title 16, Chapter 11.

**History**
- *13 DE Reg. 1322 (04/01/10)*
- *13 DE Reg. 1322 (04/01/10)*
- *24 DE Reg. 574 (12/01/20)*
- *14 DE Reg. 1360 (06/01/11)*
- *13 DE Reg. 1322 (04/01/10)*
- *15 DE Reg. 192 (08/01/11)*
- *24 DE Reg. 574 (12/01/20)*
- *13 DE Reg. 1322 (04/01/10)*
- *15 DE Reg. 79 (07/01/11)*
- *24 DE Reg. 574 (12/01/20)*
- *25 DE Reg. 759 (02/01/22)*
- *13 DE Reg. 1322 (04/01/10)*
- *16 DE Reg. 861 (02/01/13)*
- *24 DE Reg. 574 (12/01/20)*
- *13 DE Reg. 1322 (04/01/10)*
- *13 DE Reg. 1322 (04/01/10)*
- *12 DE Reg. 960 (01/01/09)*
- *13 DE Reg. 1322 (04/01/10)*
- *16 DE Reg. 861 (02/01/13)*
- *24 DE Reg. 574 (12/01/20)*
- *25 DE Reg. 759 (02/01/22)*

##### **16 Del. Admin. Code § 3201-4.0** Licensing Requirements and Procedures {#sec-3201-4.0 omnilex-key=us-de-regs-official--title-16--3201-4.0}

4.1 Licenses and renewals shall be issued to a nursing facility which meets the requirements of 16 Delaware Code, §1104. For initial licensure, the nursing facility shall also demonstrate during a physical inspection of the premises that the facility complies with all applicable regulations.

4.2 A new applicant for licensure shall substantiate a satisfactory compliance history as defined in these regulations.

4.3 The Division may consider sanctions or other information which, in combination, may impact licensure eligibility. Accordingly, the applicant shall disclose the following:

4.3.1 The imposition of temporary management by the Centers for Medicare and Medicaid Services (CMS) or any state jurisdiction against the applicant or associated entity during the preceding five years

4.3.2 The imposition of immediate jeopardy by CMS against the applicant or associated entity during the preceding five years

4.3.3 A substandard survey by CMS or any state jurisdiction against the applicant or associated entity during the preceding five years

4.3.4 The imposition of a civil money penalty by any state jurisdiction against the applicant or associated entity during the preceding five years

4.3.5 A ban on admissions by any state jurisdiction against the applicant or associated entity during the preceding five years

4.3.6 A list of all facilities managed, owned or controlled by the applicant or associated entity in any jurisdiction during the preceding five years

4.3.7 Information as required by 16 Delaware Code, §1104(e)

4.4 Financial information disclosed to the Division as required by 16 Delaware Code, §1104(e) shall not be subject to Freedom of Information Act requests except as follows:

4.4.1 Any information known to the Division regarding a civil action for debt owed by a facility

4.4.2 Any information known to the Division regarding current facility bankruptcy proceedings

4.4.3 The name of any facility currently under intensive Division review for potential financial incapability

4.5 Each license shall be renewed on the anniversary date of initial licensure. Each license holder shall file an application for renewal at least 30 days prior to the expiration of the current license and pay the applicable fee as established in 16 Delaware Code, §1106(a).

4.6 A new license shall be required in the event of a change in the nursing home management company, building owner or controlling person as defined in 16 Delaware Code, §1102(1).

4.7 Each license shall specify the number of licensed beds. A facility seeking to change the number of licensed beds shall apply to the Division for a modified license authorizing the revised number of beds.

4.8 Separate licenses are required for facilities maintained in separate locations, even though operated under the same management. A separate license is not required for separate buildings maintained by the same management on the same grounds.

4.9 When a facility plans to construct or extensively remodel a licensed facility or convert a building to a licensed facility, it shall submit one copy of properly prepared plans and specifications for the entire facility to the Division. An approval, in writing, shall be obtained before such work is begun. After the work is completed, in accordance with the plans and specifications, a modified license to operate shall be issued. All completed construction, extensive remodeling or conversions shall remain in accordance with the plans and specifications, as approved by the Division.

**History**
- *13 DE Reg. 1322 (04/01/10)*
- *13 DE Reg. 1322 (04/01/10)*
- *24 DE Reg. 574 (12/01/20)*
- *14 DE Reg. 1360 (06/01/11)*
- *13 DE Reg. 1322 (04/01/10)*
- *15 DE Reg. 192 (08/01/11)*
- *24 DE Reg. 574 (12/01/20)*
- *13 DE Reg. 1322 (04/01/10)*
- *15 DE Reg. 79 (07/01/11)*
- *24 DE Reg. 574 (12/01/20)*
- *25 DE Reg. 759 (02/01/22)*
- *13 DE Reg. 1322 (04/01/10)*
- *16 DE Reg. 861 (02/01/13)*
- *24 DE Reg. 574 (12/01/20)*
- *13 DE Reg. 1322 (04/01/10)*
- *13 DE Reg. 1322 (04/01/10)*
- *12 DE Reg. 960 (01/01/09)*
- *13 DE Reg. 1322 (04/01/10)*
- *16 DE Reg. 861 (02/01/13)*
- *24 DE Reg. 574 (12/01/20)*
- *25 DE Reg. 759 (02/01/22)*

##### **16 Del. Admin. Code § 3201-5.0** Personnel/Administrative {#sec-3201-5.0 omnilex-key=us-de-regs-official--title-16--3201-5.0}

5.1 The administrator(s) shall be responsible for complying with all applicable laws and regulations.

5.2 Each nursing facility shall have a full-time administrator. When an administrator will be temporarily absent for a period of two weeks or more, a management employee shall be designated to be in charge. The Division shall be notified in writing upon such designation.

5.3 The nursing facility shall designate a physician to serve as the medical director who shall be responsible for implementation of resident care policies and the coordination of medical care in the facility.

5.4 Nursing facilities shall provide professional nursing, nursing services direct care and other services as follows:

5.4.1 Nursing facilities subject to 16 Delaware Code, §1161 to §1165 shall provide professional nursing, nursing services direct care and other services in accordance with statutory requirements.

5.4.2 Nursing facilities not subject to 16 Delaware Code, §1161 to §1165 shall provide professional nursing, nursing services direct care and other services as follows:

5.4.2.1 The facility shall provide a sufficient number of nursing services direct care staff to provide a minimum of 2.25 hours of direct care and treatment per resident per day.

5.4.2.2 In addition to the requirement above, the nursing facility shall have a full-time director of nursing who is a registered nurse. The director of nursing shall have overall responsibility for the coordination, supervision and provision of nursing services.

5.4.2.3 At a minimum, a registered nurse or licensed practical nurse shall be on duty at all times during the first and second shifts.

5.4.2.4 At a minimum, in the absence of a nurse on the third shift, a registered nurse or licensed practical nurse shall be on call.

5.4.2.5 Facilities not subject to 16 Delaware Code, §1164 may increase the level of care and services for a current resident whose condition requires such an increase in the level of care and services as an alternative to discharge to another facility. Such increased care and services shall be provided by a qualified caregiver(s) whose scope of practice includes the provision of such care and services, and shall be available during any shift when the resident's needs require such care and services.

5.4.2.6 All other nursing services direct caregivers shall be certified nursing assistants.

5.4.2.7 The facility shall employ an activities director who shall ensure the provision of activities as described in these regulations.

5.5 The facility shall have written personnel policies and procedures. Personnel records shall be kept current and available for each employee, and include the following:

5.5.1 Results of tuberculosis screening

5.5.2 Documentation of annual influenza vaccination or refusal.

5.5.3 Results of criminal background check

5.5.4 Results of mandatory drug testing

5.5.5 Result of Adult Abuse Registry check

5.5.6 Titles and hours of in-service training

5.5.7 If applicable, license number and expiration date

5.5.8 If applicable, certification expiration date

5.5.9 Results of COVID-19 testing

5.6 Dementia Training

5.6.1 Nursing facilities that provide direct healthcare services to persons diagnosed as having Alzheimer’s disease or other forms of dementia shall provide dementia specific training each year to those healthcare providers who must participate in continuing education programs. This section shall not apply to persons certified to practice medicine under the Medical Practice Act, Chapter 17 of Title 24 of the Delaware Code.

5.6.2 The mandatory training must include: communicating with persons diagnosed as having Alzheimer’s disease or other forms of dementia; the psychological, social, and physical needs of those persons; and safety measures which need to be taken with those persons.

**History**
- *13 DE Reg. 1322 (04/01/10)*
- *13 DE Reg. 1322 (04/01/10)*
- *24 DE Reg. 574 (12/01/20)*
- *14 DE Reg. 1360 (06/01/11)*
- *13 DE Reg. 1322 (04/01/10)*
- *15 DE Reg. 192 (08/01/11)*
- *24 DE Reg. 574 (12/01/20)*
- *13 DE Reg. 1322 (04/01/10)*
- *15 DE Reg. 79 (07/01/11)*
- *24 DE Reg. 574 (12/01/20)*
- *25 DE Reg. 759 (02/01/22)*
- *13 DE Reg. 1322 (04/01/10)*
- *16 DE Reg. 861 (02/01/13)*
- *24 DE Reg. 574 (12/01/20)*
- *13 DE Reg. 1322 (04/01/10)*
- *13 DE Reg. 1322 (04/01/10)*
- *12 DE Reg. 960 (01/01/09)*
- *13 DE Reg. 1322 (04/01/10)*
- *16 DE Reg. 861 (02/01/13)*
- *24 DE Reg. 574 (12/01/20)*
- *25 DE Reg. 759 (02/01/22)*

##### **16 Del. Admin. Code § 3201-6.0** Services To Residents {#sec-3201-6.0 omnilex-key=us-de-regs-official--title-16--3201-6.0}

6.1 General Services. Any nursing facility not providing skilled services shall implement each resident's physician's orders obtained on the day of admission and renewed or revised every 60 days thereafter.

6.2 Medical Services

6.2.1 All persons admitted to a nursing facility shall be under the care of a physician licensed to practice in Delaware.

6.2.2 All nursing facilities shall arrange for one or more licensed physicians to be called in an emergency. Names, telephone and fax numbers of these physicians shall be posted at all nurses' stations.

6.2.3 For a resident admitted or readmitted from the hospital with orders for nine or more medications (excluding over-the-counter medications), the attending physician or designee or medical director shall conduct a comprehensive medication review and reconciliation of past and present medications within 5 days.

6.2.4 All written or verbal physician orders shall be signed by the attending physician or prescriber within 10 days.

6.2.5 After the initial physician visit, an advanced practice nurse or physician's assistant, affiliated with the physician, may alternate with the physician, making every other required visit.

6.2.6 A progress note shall be written and signed by the physician or designee (an advanced practice nurse or physician's assistant) after examining the resident at each visit

6.3 Nursing Administration

6.3.1 The facility's director of nursing shall:

6.3.1.1 Develop and/or maintain nursing policy and procedure manuals

6.3.1.2 Assign duties to and supervise all levels of nursing services direct caregivers

6.3.1.3 Coordinate nursing services with medical, therapy, dietary, pharmaceutical, recreational, and other ancillary services

6.3.1.4 Coordinate orientation programs for new nursing services direct caregivers (including temporary staff) and in-service education, as appropriate, for such staff. Written records of the content of each in-service program and the attendance records shall be maintained for two years

6.3.1.5 Participate in the selection of prospective residents by evaluating the nursing services required and the facility's ability to competently provide those required services or ensure that such an evaluation is conducted by a designated registered nurse

6.3.2 Treatments and medications ordered by a physician shall be administered using professionally accepted techniques in accordance with 24 Delaware Code, Chapter 19.

6.3.3 Within 14 days of admission, the facility shall make a comprehensive assessment of each resident's needs. This assessment shall include, at a minimum, the following information:

6.3.3.1 Identification, background and demographic information

6.3.3.2 Customary routine

6.3.3.3 Cognitive patterns

6.3.3.4 Communication

6.3.3.5 Vision

6.3.3.6 Mood and behavior patterns

6.3.3.7 Psychosocial well-being

6.3.3.8 Physical functioning and structural problems

6.3.3.9 Continence

6.3.3.10 Disease diagnoses and health conditions

6.3.3.11 Dental and nutritional status

6.3.3.12 Skin condition

6.3.3.13 Activity pursuits

6.3.3.14 Medications

6.3.3.15 Special treatments and procedures

6.3.3.16 Discharge potential

6.3.4 The resident assessment shall include a screening instrument for mental illness, mental retardation, and developmental disabilities to assess if an individual has an active treatment need for one of these conditions.

6.3.5 Based on the physician's admission orders and the admission information for each resident, an interim individual nursing care plan shall be developed within 24 hours of admission pending the completion of a comprehensive resident assessment.

6.3.6 A comprehensive care plan shall be developed to address medical, nursing, nutritional and psychosocial needs within 7 days of completion of the comprehensive assessment. Care plan development shall include the interdisciplinary team that includes the attending physician, an RN/LPN and other appropriate staff as determined by the resident's needs. With the resident's consent, the resident, the resident's family or the resident's legal representative may attend care plan meetings.

6.3.7 The assessment and care plan for each resident shall be reviewed/revised as needed when a significant change in physical or mental condition occurs, and at least quarterly. A complete comprehensive assessment shall be conducted and a comprehensive care plan shall be developed at least yearly from the date of the last full assessment.

6.3.8 The resident has the right to be free from any physical or chemical restraints imposed for purposes of discipline or convenience, and not required to treat the resident's medical symptoms.

6.3.8.1 The resident's comprehensive assessment shall document the medical symptom(s) potentially requiring the use of restraints.

6.3.8.2 The facility shall follow a comprehensive, systematic process of evaluation and care planning to ameliorate medical and psychosocial indicators prior to restraint use.

6.3.8.3 The resident's care plan shall document the facility's use of interventions, such as modifying the resident's environment to increase safety, and use of assistive devices to enhance monitoring in order to avoid the use of restraints.

6.3.8.4 Should such interventions and assistive devices fail to provide for the resident's safety, a physician's written order permitting the use of restraints shall be required and shall specify the type of restraint ordered.

6.3.8.5 The facility shall be accountable for the safe and effective implementation of the physician's order permitting the use of restraints.

6.3.8.6 When the use of restraints has been implemented, the facility shall initiate a systematic process, on an ongoing basis, documented in the care plan, in an effort to employ the least restrictive restraint.

6.3.8.7 In an emergency, when the resident's unanticipated violent or aggressive behavior places him/her or others in imminent danger, restraints may be used as a last resort to protect the safety of the resident or others, and such use shall not extend beyond the immediate episode.

6.3.9 The facility shall ensure that each nursing and ancillary staff member providing care to a resident under 18 years of age meets the standards as defined in regulations for nursing facilities admitting pediatric residents.

6.3.10 The facility shall ensure that all licensed or certified direct care staff receive CPR certification and shall ensure that at least one staff person with current CPR certification is present in the facility during all shifts.

6.4 Social Services

6.4.1 The facility shall identify each resident's need for social services to attain or maintain the highest practicable physical, mental and psychosocial well-being of each resident; and shall assist each resident to obtain all required services to meet the individual resident's needs. These social services shall include, but not be limited to:

6.4.1.1 Making arrangements for obtaining needed adaptive equipment, clothing and personal items

6.4.1.2 Making referrals and obtaining services from outside entities

6.4.1.3 Assisting residents with financial and legal matters, according to facility policy

6.4.1.4 Discharge planning services

6.4.1.5 Assisting residents to determine how they would like to make decisions about their health care, and whether or not they would like anyone else to be involved in those decisions

6.4.1.6 Meeting the needs of residents who are grieving

6.5 Food Service

6.5.1 Meals. Therapeutic diets, mechanical alterations and changes in either must be prescribed by an attending physician within 72 hours of implementation. All meals and snacks shall be served in accordance with the therapeutic diet, if prescribed.

6.5.2 Menus

6.5.2.1 Menus shall be planned in advance and a copy of the current week's menu shall be posted in the kitchen and in a public area. Portion sizes shall be listed on a menu in the food service area.

6.5.2.2 Menus showing food actually served each day shall be kept on file for at least 3 months. When changes in the menu are necessary, substitutions of similar nutritive value shall be provided.

6.5.2.3 A 3-day supply of food shall be kept on the premises at all times.

6.5.2.4 A copy of a recent dietary manual shall be available for planning therapeutic menus and as a resource for staff.

6.5.3 Nutritional Assessment

6.5.3.1 The immediate nutritional needs of each resident shall be addressed upon admission.

6.5.3.2 A comprehensive nutritional assessment which includes an evaluation of each resident's caloric, protein, and fluid requirements shall be completed within 14 days of admission in consultation with a dietitian.

6.5.3.3 The facility shall have an ongoing evaluation and assessment program to meet the nutritional needs of all residents.

6.5.3.4 The facility shall obtain and document each resident's weight at least monthly.

6.6 Housekeeping and Laundry Services

6.6.1 The facility shall maintain a safe, clean, and orderly environment, free from offensive odors, for the interior and exterior of the facility.

6.6.2 A full-time employee shall be designated responsible for housekeeping services and for supervision and training of personnel.

6.6.3 The facility shall have written policies and procedures and schedules for cleaning all areas of the facility.

6.6.4 The facility shall maintain a supply, in the amount of 3 sets per resident, of towels, washcloths, sheets and pillowcases changed weekly or whenever soiled.

6.6.5 The facility's handling, storage, processing and transporting of linens shall comply with facility infection control policies and procedures.

6.6.6 The facility shall contract with a licensed pest control vendor to ensure that the entire facility is free of live insects and other vermin.

6.7 Pharmacy Services

6.7.1 Each nursing facility shall have a consultant pharmacist who shall be responsible for the general supervision of the nursing facility's pharmaceutical services.

6.7.2 For a resident admitted or readmitted from the hospital with orders for nine or more medications (excluding over-the-counter medications), the facility shall complete an on-site or off-site pharmacy review within 10 days of admission or readmission.

6.8 Medications

6.8.1 Medication Administration

6.8.1.1 All medications (prescription and over-the-counter) shall be administered to residents in accordance with orders which are signed and dated by the ordering physician or prescriber. Each medication shall have a documented supporting diagnosis. Verbal or telephone orders shall be written by the nurse receiving the order and then signed by the ordering physician or prescriber within 10 days.

6.8.1.2 Standing orders may be established for over-the-counter medications that have been approved by the resident's attending physician.

6.8.1.3 Standing orders shall be initiated by licensed nurses, but shall not be used for more than 72 hours without approval by the physician.

6.8.1.4 When any standing order is initiated, it shall be written as a complete order on the MAR for the specified time period and charted when administered.

6.8.1.5 Medications shall be given only to the individual resident for whom the prescription or order was issued, and shall be given in accordance with the prescriber's instructions.

6.8.1.6 An individual resident may self-administer medications upon the written order of the physician, following determination by the interdisciplinary team that this practice is safe. The facility shall establish policies and procedures pertaining to the security of self-administered medication.

6.8.1.7 The facility's policies and procedures shall not prohibit or restrict a resident from receiving medications from the pharmacy of the resident's choice. However, the resident and/or his representative shall be informed of any ramifications of ordering medications from other than the facility's pharmacy, such as cost differences, responsibility for delivery of medication to the facility and length of ordering time.

6.8.1.8 Only licensed nurses shall administer medications and then record the administration on the resident's Medication Administration Record (MAR) immediately after administration to that resident.

6.8.1.9 The facility shall ensure that licensed nurses administering medications count controlled substances at the beginning and end of each shift. The on-coming medication nurse shall conduct, verify, and document the controlled substance count in the presence of the off-going medication nurse.

6.8.1.10 Any medications removed but not administered to the resident shall not be returned to the original container. In circumstances such as refusal of drugs by the resident, the drugs shall be discarded and the refusal recorded on the resident's Medication Administration Record (MAR). If the medication is a controlled substance, the signature of the administering nurse is required on the record of the controlled substance count.

6.8.1.11 Each nursing home shall have available a current edition of at least one drug reference text for the nursing staff.

6.8.1.12 Medication shall be released to residents on discharge or transfer only by the written authorization of the resident's physician. A resident who leaves the nursing facility on a short leave may be issued a quantity of medication to meet his/her needs, with the approval of the resident's physician.

6.8.1.13 The barrel, plunger, needle and contents of disposable hypodermic syringes shall be properly discarded in accordance with OSHA regulations immediately after use.

6.8.1.14 The administrator or designee shall notify the Office of Controlled Substances in the Division of Professional Regulation and the Division of Long Term Care Residents Protection of any unexplained loss of controlled substances, syringes, needles, or prescription pads within 8 hours of discovery of such loss or theft.

6.8.2 Medication Storage and Stocks

6.8.2.1 Stock supplies of drugs available without a prescription (over-the-counter drugs such as antacids, aspirin, laxatives) may be kept in the facility. These over-the-counter drugs shall be labeled "house stock”.

6.8.2.2 All medications shall be stored in a locked cabinet. The key to the cabinet shall be kept in the control of the licensed nurse responsible for the administration of medications.

6.8.2.3 Prescription medications for emergency or interim use may be stocked by the facility subject to Board of Pharmacy regulations.

6.8.3 Medication Labeling

6.8.3.1 Medications shall be labeled in accordance with 24 Delaware Code, §2522 and the regulations of the Board of Pharmacy.

6.8.3.2 Medications dispensed using a unit dose system shall be pharmacy-prepared or manufacturer-prepared in individually packaged and sealed doses that are identifiable and properly labeled. The label shall include, at a minimum, the brand and/or generic name of the medication, strength, and lot number and expiration date.

6.9 Communicable Diseases

6.9.1 General Requirements

6.9.1.1 The facility shall follow Division of Public Health regulations for the Control of Communicable and Other Disease Conditions and Centers for Disease Control guidelines for communicable diseases.

6.9.1.2 The facility shall establish written policies and procedures implementing the Division of Public Health regulations and Centers for Disease Control guidelines for communicable diseases.

6.9.1.3 The nursing facility shall ensure that the necessary precautions stated in the policies and procedures are followed.

6.9.1.4 A resident, when suspected or diagnosed as having a communicable disease, shall be placed on the appropriate precautions as recommended for that disease by the Centers for Disease Control. Residents infected or colonized with the same organism may share a room based on current standard of practice.

6.9.1.5 The admission of a resident with or the occurrence of a disease or condition on the Division of Public Health List of Notifiable Diseases/Conditions within a nursing facility shall be reported to the resident's physician and the facility's medical director. The facility shall also report such an admission or occurrence to the Division of Public Health's Health Information and Epidemiology office.

6.9.2 Specific Requirements for Tuberculosis

6.9.2.1 A resident diagnosed with active tuberculosis in an infectious stage shall not continue to reside in a nursing facility unless that facility has a room with negative pressure ventilation and staff trained to care for residents requiring respiratory isolation.

6.9.2.2 A resident of any facility unable to provide care as described above who is diagnosed with active tuberculosis in an infectious stage shall be transferred to an acute care hospital, and the facility shall notify the Division of Public Health's Health Information and Epidemiology office immediately.

6.9.2.3 The facility shall have on file the results of tuberculin testing performed on all newly placed residents.

6.9.2.4 Minimum requirements for pre-employment tuberculosis (TB) testing require all employees to have a base line two step tuberculin skin test (TST) or single Interferon Gamma Release Assay (IGRA or TB blood test) such as QuantiFeron. Any required subsequent testing according to risk category shall be in accordance with the recommendations of the Centers for Disease Control and Prevention of the U.S. Department of Health and Human Services. Should the category of risk change, which is determined by the Division of Public Health, the facility shall comply with the recommendations of the Center for Disease Control for the appropriate risk category.

6.9.2.4.1 No person, including volunteers, found to have active tuberculosis in an infectious stage shall be permitted to give care or service to residents.

6.9.2.4.2 Any person having a positive skin test but a negative X-ray shall receive an annual evaluation for signs and symptoms of active TB if they can not provide documentation of completion of treatment for LTBI (latent TB infection).

6.9.2.4.3 Persons with a prior BCG vaccination are required to be tested as set forth in 6.9.2.4.

6.9.3 Immunizations

6.9.3.1 All facilities shall have on file evidence of annual vaccination against influenza for all residents, as recommended by the Immunization Practice Advisory Committee of the Centers for Disease Control, unless medically contraindicated.

6.9.3.2 All facilities shall have on file evidence of vaccination against pneumococcal pneumonia for all residents older than 65 and as recommended by the Immunization Practice Advisory Committee of the Centers for Disease Control unless medically contraindicated.

6.9.3.3 A resident who refuses to be vaccinated against influenza or pneumococcal pneumonia shall be informed by the facility of the health risks involved. The reason for the refusal(s) shall be documented in the resident's medical record annually.

6.9.4 Employee Health

6.9.4.1 All employees shall receive education and training on standard precautions, use of personal protective equipment, the importance of hand hygiene, the facility's infection control policies and reporting of exposures to blood or other potentially infectious materials.

6.9.4.2 Personal protective equipment, as required by Centers for Disease Control guidelines, shall be made available by the facility for employee use.

6.9.4.3 If an accidental exposure to blood or other potentially infectious materials occurs (specifically to eye, mouth, other mucous membrane or non-intact skin), appropriate first aid treatment shall be given immediately and follow-up testing and counsel initiated. A copy of the exposure incident and follow-up treatment shall be maintained in the employee's personnel file.

6.9.4.4 Facilities shall establish procedures in accordance with Division of Public Health requirements and Centers for Disease Control guidelines for exclusion from work and authorization to return to work for staff with communicable diseases.

6.10 Infection Control

6.10.1 Infection Prevention and Control Program

6.10.1.1 The nursing facility shall establish an infection prevention and control program (or a subcommittee of an overall quality control program) of professional staff whose responsibility shall be to manage the infection control program in the facility. One member of the program shall be designated the infection control coordinator.

6.10.1.2 The infection prevention and control program shall consist of members of the medical and nursing staffs, administration, dietetic department, pharmacy, housekeeping, maintenance, and therapy services.

6.10.1.3 The infection prevention and control program shall be based upon the Centers for Disease Control and Prevention and other nationally recognized infection prevention and control guidelines.

6.10.1.3.1 The infection prevention and control program must cover all services and all areas of the nursing facility, including provision of the appropriate personal protective equipment for all patients/residents, staff, and visitors.

6.10.1.4 The infection control coordinator must:

6.10.1.4.1 Develop and implement a comprehensive plan that includes actions to prevent, identify and manage infections and communicable diseases. The plan must include mechanisms that result in immediate action to take preventive or corrective measures that improve the nursing facility’s infection control outcomes.

6.10.1.4.2 Maintain records of all nosocomial infections and corrective actions related to those infections to enable the committee to analyze clusters or significant increases in the rate of infection and to make recommendations for the prevention and control of additional cases.

6.10.1.5 The infection control committee shall establish the infection control training of staff and volunteers, and disseminate current information on health practices.

6.10.2 Infectious Waste

6.10.2.1 The facility shall establish and implement policies and procedures for the collection, storage, handling and disposition of all pathological and infectious wastes within the facility as well as for those to be removed from the facility including the following:

6.10.2.1.1 Needles, syringes and other solid, sharp, or rigid items shall be placed in a puncture resistant container prior to disposal by an infectious waste hauler approved by the Department of Natural Resources and Environmental Control (DNREC).

6.10.2.1.2 Non-rigid items, such as blood tubing and disposable equipment and supplies, shall be placed in double, heavy duty, impervious plastic bags prior to disposal by an infectious waste hauler approved by DNREC.

6.11 Specific Requirements for COVID-19

6.11.1 Residents

6.11.1.1 All residents should be tested upon identification of another resident with symptoms consistent with COVID-19, or if facility staff have tested positive for COVID-19.

6.11.1.2 All other resident testing should be consistent with Division of Public Health guidance for the duration of the public health emergency.

6.11.1.3 All testing and test results must be documented in the resident medical record.

6.11.1.4 Facilities must report all resident testing and test results, to the Delaware Division of Public Health.

6.11.2 Staff, vendors and volunteers

6.11.2.1 Prior to their start date, all new staff, vendors and volunteers must be tested in accordance with the Delaware Division of Public Health guidance.

6.11.2.2 All staff, vendors and volunteers who test negative must be retested consistent with Division of Public Health guidance for the duration of the public health emergency.

6.11.2.3 Facilities must report all staff, vendor and volunteer testing and test results, to the Delaware Division of Public Health.

6.11.2.4 Facilities must follow recommendations of the Centers for Disease Control and Prevention of the U.S. Department of Health and Human Services and the Division of Public Health regarding the provision of care or services to residents by staff, vendor or volunteer found to be positive for COVID-19 in an infectious stage.

6.11.2.5 Facilities shall amend their policies and procedures for communicable disease to include:

6.11.2.5.1 Work exclusion and return to work protocols for staff tested positive for COVID-19.

6.11.2.5.2 Staff refusals to participate in COVID-19 testing.

6.11.2.5.3 Staff refusals to authorize release of their testing results to the nursing facility.

6.11.2.5.4 Procedures to obtain staff authorizations for release of laboratory test results to the facility so as to inform infection control and prevention strategies.

6.11.2.5.5 Plans to address staffing shortages and facility demands should a COVID-19 outbreak occur.

**History**
- *13 DE Reg. 1322 (04/01/10)*
- *13 DE Reg. 1322 (04/01/10)*
- *24 DE Reg. 574 (12/01/20)*
- *14 DE Reg. 1360 (06/01/11)*
- *13 DE Reg. 1322 (04/01/10)*
- *15 DE Reg. 192 (08/01/11)*
- *24 DE Reg. 574 (12/01/20)*
- *13 DE Reg. 1322 (04/01/10)*
- *15 DE Reg. 79 (07/01/11)*
- *24 DE Reg. 574 (12/01/20)*
- *25 DE Reg. 759 (02/01/22)*
- *13 DE Reg. 1322 (04/01/10)*
- *16 DE Reg. 861 (02/01/13)*
- *24 DE Reg. 574 (12/01/20)*
- *13 DE Reg. 1322 (04/01/10)*
- *13 DE Reg. 1322 (04/01/10)*
- *12 DE Reg. 960 (01/01/09)*
- *13 DE Reg. 1322 (04/01/10)*
- *16 DE Reg. 861 (02/01/13)*
- *24 DE Reg. 574 (12/01/20)*
- *25 DE Reg. 759 (02/01/22)*

##### **16 Del. Admin. Code § 3201-7.0** Plant, Equipment and Physical Environment {#sec-3201-7.0 omnilex-key=us-de-regs-official--title-16--3201-7.0}

7.1 All new construction, extensive remodeling or conversions to a nursing facility shall comply with the standards and guidelines set forth under the "Nursing Facilities" section of the current edition of Guidelines for Design and Construction of Health Care Facilities, a publication of the American Institute of Architects Committee on Architecture for Health with assistance of the U.S. Department of Health and Human Services.

7.2 The facility shall be handicapped accessible and meet applicable American National Standards Institute (A.N.S.I.) standards.

7.3 Facility Systems Requirements

7.3.1 Water Supply and Sewage Disposal

7.3.1.1 The facility water supply and sewage disposal system shall comply with Division of Public Health and Department of Natural Resources and Environmental Control standards, respectively.

7.3.1.2 The water system shall supply hot and cold water under sufficient pressure to satisfy facility needs at peak demand.

7.3.1.3 Hot water accessible to residents shall not exceed 110° F.

7.3.2 Heating, Ventilation, Air Conditioning. The HVAC system for all areas used by residents shall be safe and easily controlled.

7.3.3 Facility lighting shall meet current standards of the Guidelines for Design and Construction of Health Care Facilities.

7.3.4 The facility shall be equipped with a resident call system which meets the current standards of the Guidelines for Design and Construction of Health Care Facilities. An intermediate care facility serving only developmentally disabled residents shall be exempt from this regulation.

7.4 Physical Environment Requirements

7.4.1 Safety Requirements

7.4.1.1 Stairs shall have stair treads and handrails.

7.4.1.2 Hallways shall have handrails on both sides of corridors. An intermediate care facility serving only developmentally disabled residents shall be exempt from this regulation.

7.4.1.3 Non-skid flooring materials shall be used and maintained in good condition.

7.4.2 Bedrooms

7.4.2.1 Each resident shall be provided with a reading light. At least one bedroom light shall be controlled by a switch at the bedroom entrance.

7.4.2.2 The facility shall provide at least one room with private toilet and hand washing sink for residents who require isolation.

7.4.3 Bathrooms

7.4.3.1 Bathroom walls and floors shall be impervious to water. Bathrooms shall have at least one window or mechanical ventilation exhausted to the outside.

7.4.3.2 A minimum of one bathtub or shower shall be provided for every 20 residents not otherwise served by bathing facilities within residents' rooms. Each nursing unit shall have at least one bathtub.

7.4.3.3 Each tub or shower in a central bathing facility shall be in an individual room or enclosure with space for the private use of the tub or shower, for drying and dressing, and for a wheelchair and attendant. Showers shall be at least four feet square without curbs. Toilets in central bathing facilities shall have provisions for privacy.

7.4.3.4 Each resident's room shall have direct access to a hand washing sink and a toilet.

7.4.3.5 A wall-mounted hand grip shall be provided at each resident toilet, bath tub and shower.

7.4.3.6 Separate bathroom and hand washing sinks shall be provided for the staff.

7.4.4 Resident Common Areas

7.4.4.1 Areas for resident recreational and social activities shall provide at least 30 square feet per bed for the first 100 beds and 27 square feet per bed for beds in excess of 100.

7.4.4.2 The dining areas shall accommodate all residents.

7.4.4.3 Facilities for resident hair care and grooming shall be separate from resident rooms.

7.4.4.4 Equipment and materials for resident hair care and grooming shall comply with facility infection control policies and procedures.

7.5 Kitchen and Food Storage Areas. Facilities shall comply with the Delaware Food Code.

7.6 Sanitation and Laundry

7.6.1 The facility shall provide for the safe storage of cleaning materials, pesticides and other potentially toxic materials.

7.6.2 Each facility shall have a janitor's closet containing a service sink.

7.6.3 For on-site laundry processing, the facility shall:

7.6.3.1 Provide a room under negative air pressure for receiving, sorting, and washing soiled linen.

7.6.3.1.1 If hot water is used for destroying micro-organisms, washers must be supplied with water heated to a minimum of 160º F.

7.6.3.1.2 If low temperature laundry cycles are used, a total available chlorine residual of 50-150 ppm must be present and monitored during the wash cycle.

7.6.3.2 Provide a room under positive air pressure for drying and folding clean linen, equipped with a hand washing sink.

7.6.4 For off-site laundry processing, the facility shall:

7.6.4.1 Contract with a commercial laundry.

7.6.4.2 Provide a soiled linen holding room (or a designated area in the soiled utility room) under negative air pressure for the storage of soiled linen.

7.6.4.3 Provide a clean linen storage area.

7.6.5 The facility shall have a soiled utility room under negative pressure for storage of infectious waste and for disposal of body fluids. The room shall have a work counter, hand washing sink, and clinical sink or other bed pan cleaning device.

7.7 Equipment and Supplies

7.7.1 The facility shall supply sufficient equipment and supplies for nursing care to meet the needs of each resident. The facility shall obtain specific items when indicated for individual residents and approved by the attending physician or director of nursing.

7.7.2 The facility shall provide each resident with:

7.7.2.1 A hospital bed of appropriate size with a mattress covered with non-porous material. Modifications or attachments to the bed shall conform to manufacturer's specifications.

7.7.2.2 A bedside stand with a drawer and storage space for a bedpan, urinal, emesis basin and washbasin.

7.7.2.3 A minimum of two drawers in a dresser or chest of drawers.

7.7.2.4 A closet or wardrobe.

7.7.2.5 A chair suitable for resident relaxation.

7.7.2.6 An over-bed table.

7.7.3 The facility shall provide cubicle curtains around each bed in bedrooms occupied by more than one resident.

7.7.4 The facility shall provide sufficient storage space on each nursing unit for nursing supplies and equipment.

7.7.5 The facility shall provide safe storage for residents' valuables.

7.7.6 The facility shall maintain a functioning scale, calibrated quarterly, capable of accurately weighing each resident.

**History**
- *13 DE Reg. 1322 (04/01/10)*
- *13 DE Reg. 1322 (04/01/10)*
- *24 DE Reg. 574 (12/01/20)*
- *14 DE Reg. 1360 (06/01/11)*
- *13 DE Reg. 1322 (04/01/10)*
- *15 DE Reg. 192 (08/01/11)*
- *24 DE Reg. 574 (12/01/20)*
- *13 DE Reg. 1322 (04/01/10)*
- *15 DE Reg. 79 (07/01/11)*
- *24 DE Reg. 574 (12/01/20)*
- *25 DE Reg. 759 (02/01/22)*
- *13 DE Reg. 1322 (04/01/10)*
- *16 DE Reg. 861 (02/01/13)*
- *24 DE Reg. 574 (12/01/20)*
- *13 DE Reg. 1322 (04/01/10)*
- *13 DE Reg. 1322 (04/01/10)*
- *12 DE Reg. 960 (01/01/09)*
- *13 DE Reg. 1322 (04/01/10)*
- *16 DE Reg. 861 (02/01/13)*
- *24 DE Reg. 574 (12/01/20)*
- *25 DE Reg. 759 (02/01/22)*

##### **16 Del. Admin. Code § 3201-8.0** Emergency Preparedness {#sec-3201-8.0 omnilex-key=us-de-regs-official--title-16--3201-8.0}

8.1 Nursing facilities shall comply with the rules and regulations adopted and enforced by the State Fire Prevention Commission or the municipality with jurisdiction.

8.2 Regular fire drills shall be held at least quarterly on each shift. Written records shall be kept of attendance at such drills.

8.3 Each facility shall develop and maintain all-hazard emergency plans for evacuation and sheltering in place. The plan must be submitted to the Division and DEMA in a digital format and it must conform to the template prescribed by the Division. The all-hazard emergency plan must include plans to address staffing shortages and facility demands.

8.4 The staff on all shifts shall be trained on emergency and evacuation plans. Evacuation routes shall be posted in a conspicuous place at each nursing station.

8.5 In the event of a facility evacuation, the evacuation plan shall, at a minimum, provide for the transfer or availability of resident medications and records.

8.6 Each facility shall submit with an application for a license and annual renewal of a license:

8.6.1 A current all hazards emergency plan, and

8.6.2 Copies of the FEMA certificate of achievement which demonstrate that at least two active, full-time employees have completed FEMA training in ICS-100 and NIMS-700a in the past 24 months.

8.7 The Division may grant an extension of time for either requirement in 8.6 upon request and for good cause shown.

**History**
- *13 DE Reg. 1322 (04/01/10)*
- *13 DE Reg. 1322 (04/01/10)*
- *24 DE Reg. 574 (12/01/20)*
- *14 DE Reg. 1360 (06/01/11)*
- *13 DE Reg. 1322 (04/01/10)*
- *15 DE Reg. 192 (08/01/11)*
- *24 DE Reg. 574 (12/01/20)*
- *13 DE Reg. 1322 (04/01/10)*
- *15 DE Reg. 79 (07/01/11)*
- *24 DE Reg. 574 (12/01/20)*
- *25 DE Reg. 759 (02/01/22)*
- *13 DE Reg. 1322 (04/01/10)*
- *16 DE Reg. 861 (02/01/13)*
- *24 DE Reg. 574 (12/01/20)*
- *13 DE Reg. 1322 (04/01/10)*
- *13 DE Reg. 1322 (04/01/10)*
- *12 DE Reg. 960 (01/01/09)*
- *13 DE Reg. 1322 (04/01/10)*
- *16 DE Reg. 861 (02/01/13)*
- *24 DE Reg. 574 (12/01/20)*
- *25 DE Reg. 759 (02/01/22)*

##### **16 Del. Admin. Code § 3201-9.0** Records and Reports {#sec-3201-9.0 omnilex-key=us-de-regs-official--title-16--3201-9.0}

9.1 There shall be a separate clinical record maintained on each resident as a chronological history of the resident's stay in the nursing facility. Each resident's record shall contain current and accurate information including the following:

9.1.1 Admission record which shall include the resident's name, birth date, home address prior to entering the facility, identification numbers (including Social Security), date of admission, physician's name, address and telephone number, admitting diagnoses, name, address and telephone number of resident's representative, the facility's medical record number, and advance directive(s) if applicable.

9.1.2 History and physical examination prepared by a physician within 14 days of the resident's admission to the nursing facility. If the resident has been admitted to the facility from a hospital, the resident's summary and history prepared at the hospital and the resident's physical examination performed at the hospital, if performed within 14 days prior to admission to the facility, may be substituted. A record of subsequent annual medical evaluations performed by a physician must be contained in each resident's file.

9.1.3 A record of post-admission diagnoses.

9.1.4 Physician's orders which include a complete list of medications, dosages, frequency and route of administration, indication for usage, treatments, diets, restrictions on level of permitted activity if any, and use of restraints if applicable.

9.1.5 Physician's progress notes.

9.1.6 Nursing notes, which shall be recorded by each person providing professional nursing services to the resident, indicating date, time, scope of service provided and signature of the provider of the service. Nursing notes shall include care issues, nursing observations, resident change of status and other significant events.

9.1.7 Medication administration record (MAR) including medications, dosages, frequency, route of administration, and initials of the nurse administering each dose. The record shall include the signature of each nurse whose initials appear on the MAR.

9.1.8 Inventory of resident's personal effects upon admission.

9.1.9 Results of laboratory tests, x-ray reports and results of other tests ordered by the physician.

9.1.10 Discharge record which includes date and time, discharge location, and condition of resident.

9.1.11 Special service notes, e.g., social services, activities, specialty consultations, physical therapy, dental, podiatry.

9.1.12 Interagency transfer form, if applicable.

9.1.13 Copies of power(s) of attorney and guardianship, if applicable.

9.1.14 Nutrition progress notes and record of resident weights.

9.1.15 CNA flow sheets.

9.2 Confidentiality of resident records shall be maintained in accordance with the federal Health Insurance Portability and Accountability Act (HIPAA) and 16 Delaware Code, §1121(6).

9.3 Records shall be retained for 6 years after discharge. For a minor, records shall be retained for three years after age of majority.

9.4 Electronic Record keeping

9.4.1 Where facilities maintain residents' records in electronic format by computer or other devices, electronic signatures shall be acceptable.

9.4.2 The facility shall have a written attestation policy.

9.4.3 The computer network and all devices used to maintain resident medical records shall have safeguards to prevent unauthorized access and alteration of records.

9.4.4 All data entry devices shall require user authentication to access the computer network.

9.4.5 The computer program shall control each person's extent of access to residents' records based on that individual's personal identifier.

9.4.6 The computer's internal clock shall record the date and time of each entry.

9.4.7 An entry, once recorded, shall not be deleted. Alterations or corrections shall supplement the original record.

9.4.8 All entries shall have the date and time of the entry and the individual's personal identifier logged in a file which is accessible to designated administrative staff only.

9.4.9 The computer system shall back up all data to ensure record retention.

9.4.10 The facility shall provide independent computer access to electronic records to satisfy the requirements of the survey and certification process.

9.5 Incident reports, with adequate documentation, shall be completed for each incident. Adequate documentation shall consist of the name of the resident(s) involved; the date, time and place of the incident; a description of the incident; a list of other parties involved, including witnesses; the nature of any injuries; resident outcome; and follow-up action, including notification of the resident's representative or family, attending physician and licensing or law enforcement authorities, when appropriate.

9.6 All incident reports whether or not required to be reported shall be retained in facility files for three years. Reportable incidents shall be communicated immediately, which shall be within eight hours of the occurrence of the incident, to the Division of Long Term Care Residents Protection. The method of reporting shall be as directed by the Division.

9.7 Incident reports which shall be retained in facility files are as follows:

9.7.1 All reportable incidents as detailed below.

9.7.2 Falls without injury and falls with minor injuries that do not require transfer to an acute care facility or neurological reassessment of the resident.

9.7.3 Errors or omissions in treatment or medication.

9.7.4 Injuries of unknown source.

9.7.5 Lost items which are not subject to financial exploitation.

9.7.6 Skin tears.

9.7.7 Bruises of unknown origin.

9.8 Reportable incidents are as follows:

9.8.1 Abuse as defined in 16 Delaware Code, §1131.

9.8.1.1 Physical abuse with injury if resident to resident and physical abuse with or without injury if staff to resident or any other person to resident.

9.8.1.2 Any sexual act between staff and a resident and any non-consensual sexual act between residents or between a resident and any other person such as a visitor.

9.8.1.3 Emotional abuse whether staff to resident, resident to resident or any other person to resident.

9.8.2 Neglect, mistreatment or financial exploitation as defined in 16 Delaware Code, §1131.

9.8.3 Resident elopement under the following circumstances:

9.8.3.1 A resident's whereabouts on or off the premises are unknown to staff and the resident suffers harm.

9.8.3.2 A cognitively impaired resident's whereabouts are unknown to staff and the resident leaves the facility premises.

9.8.3.3 A resident cannot be found inside or outside a facility and the police are summoned.

9.8.4 Significant injuries.

9.8.4.1 Injury from an incident of unknown source in which the initial investigation or evaluation supports the conclusion that the injury is suspicious. Circumstances which may cause an injury to be suspicious are: the extent of the injury, the location of the injury (e.g., the injury is located in an area not generally vulnerable to trauma), the number of injuries observed at one particular point in time, or the incidence of injuries over time.

9.8.4.2 Injury which results in transfer to an acute care facility for treatment or evaluation or which requires periodic neurological reassessment of the resident's clinical status by professional staff for up to 24 hours.

9.8.4.3 Areas of contusions or bruises caused by staff to a dependent resident during ambulation, transport, transfer or bathing.

9.8.4.4 Significant error or omission in medication/treatment, including drug diversion, which causes the resident discomfort, jeopardizes the resident's health and safety or requires periodic monitoring for up to 48 hours.

9.8.4.5 A burn greater than first degree.

9.8.4.6 Any serious unusual and/or life-threatening injury.

9.8.5 Entrapment which causes the resident injury or immobility of body or limb or which requires assistance from another person for the resident to secure release.

9.8.6 Suicide or attempted suicide.

9.8.7 Poisoning.

9.8.8 Fire within a facility.

9.8.9 Utility interruption lasting more than eight hours in one or more major service including electricity, water supply, plumbing, heating or air conditioning, fire alarm, sprinkler system or telephones.

9.8.10 Structural damage or unsafe structural conditions.

9.8.11 Water damage which impacts resident health, safety or comfort.

9.9 The facility shall maintain written policies and procedures, in accordance with 16 Delaware Code Chapter 25, regarding health care decisions including advance directives. The facility shall provide written information to all residents explaining such policies and procedures.

**History**
- *13 DE Reg. 1322 (04/01/10)*
- *13 DE Reg. 1322 (04/01/10)*
- *24 DE Reg. 574 (12/01/20)*
- *14 DE Reg. 1360 (06/01/11)*
- *13 DE Reg. 1322 (04/01/10)*
- *15 DE Reg. 192 (08/01/11)*
- *24 DE Reg. 574 (12/01/20)*
- *13 DE Reg. 1322 (04/01/10)*
- *15 DE Reg. 79 (07/01/11)*
- *24 DE Reg. 574 (12/01/20)*
- *25 DE Reg. 759 (02/01/22)*
- *13 DE Reg. 1322 (04/01/10)*
- *16 DE Reg. 861 (02/01/13)*
- *24 DE Reg. 574 (12/01/20)*
- *13 DE Reg. 1322 (04/01/10)*
- *13 DE Reg. 1322 (04/01/10)*
- *12 DE Reg. 960 (01/01/09)*
- *13 DE Reg. 1322 (04/01/10)*
- *16 DE Reg. 861 (02/01/13)*
- *24 DE Reg. 574 (12/01/20)*
- *25 DE Reg. 759 (02/01/22)*

##### **16 Del. Admin. Code § 3201-10.0** Facility Closure {#sec-3201-10.0 omnilex-key=us-de-regs-official--title-16--3201-10.0}

10.1 In the event of the closing of a facility, the facility shall:

10.1.1 Notify the Division of Long Term Care Residents Protection, the Ombudsman, the Division of Public Health and, if applicable, the Division of Medicaid and Medical Assistance and the Centers for Medicare and Medicaid Services at least 90 days before the planned closure.

10.1.2 Notify each resident directly and his/her attending physician and, if applicable, his/her responsible party by telephone and in writing at least 90 days before the planned closure.

10.1.3 Give the resident or the resident's responsible person an opportunity to designate a preference for relocation to a specific facility or for other arrangements.

10.1.4 Arrange for relocation to other facilities in accordance with the resident's preference, if possible.

10.1.5 Ensure that all resident records, medications, and personal belongings are transferred with the resident and, if to another facility, accompanied by the interagency transfer form.

10.1.6 Provide an accounting of resident trust fund accounts which shall be transferred to each resident's possession or to the facility to which the resident relocates. A record of the accounting of the funds shall be maintained by the closing facility for audit purposes.

10.1.7 Advise any applicant for admission to a facility which has a planned closure date in writing of the planned closure date prior to admission.

**History**
- *13 DE Reg. 1322 (04/01/10)*
- *13 DE Reg. 1322 (04/01/10)*
- *24 DE Reg. 574 (12/01/20)*
- *14 DE Reg. 1360 (06/01/11)*
- *13 DE Reg. 1322 (04/01/10)*
- *15 DE Reg. 192 (08/01/11)*
- *24 DE Reg. 574 (12/01/20)*
- *13 DE Reg. 1322 (04/01/10)*
- *15 DE Reg. 79 (07/01/11)*
- *24 DE Reg. 574 (12/01/20)*
- *25 DE Reg. 759 (02/01/22)*
- *13 DE Reg. 1322 (04/01/10)*
- *16 DE Reg. 861 (02/01/13)*
- *24 DE Reg. 574 (12/01/20)*
- *13 DE Reg. 1322 (04/01/10)*
- *13 DE Reg. 1322 (04/01/10)*
- *12 DE Reg. 960 (01/01/09)*
- *13 DE Reg. 1322 (04/01/10)*
- *16 DE Reg. 861 (02/01/13)*
- *24 DE Reg. 574 (12/01/20)*
- *25 DE Reg. 759 (02/01/22)*

##### **16 Del. Admin. Code § 3201-11.0** Waivers and Severability {#sec-3201-11.0 omnilex-key=us-de-regs-official--title-16--3201-11.0}

11.1 Waivers may be granted by the Division of Long Term Care Residents Protection for good cause.

11.2 Should any section, sentence, clause or phrase of these regulations be legally declared unconstitutional or invalid for any reason, the remainder of said regulations shall not be affected thereby.

**History**
- *13 DE Reg. 1322 (04/01/10)*
- *13 DE Reg. 1322 (04/01/10)*
- *24 DE Reg. 574 (12/01/20)*
- *14 DE Reg. 1360 (06/01/11)*
- *13 DE Reg. 1322 (04/01/10)*
- *15 DE Reg. 192 (08/01/11)*
- *24 DE Reg. 574 (12/01/20)*
- *13 DE Reg. 1322 (04/01/10)*
- *15 DE Reg. 79 (07/01/11)*
- *24 DE Reg. 574 (12/01/20)*
- *25 DE Reg. 759 (02/01/22)*
- *13 DE Reg. 1322 (04/01/10)*
- *16 DE Reg. 861 (02/01/13)*
- *24 DE Reg. 574 (12/01/20)*
- *13 DE Reg. 1322 (04/01/10)*
- *13 DE Reg. 1322 (04/01/10)*
- *12 DE Reg. 960 (01/01/09)*
- *13 DE Reg. 1322 (04/01/10)*
- *16 DE Reg. 861 (02/01/13)*
- *24 DE Reg. 574 (12/01/20)*
- *25 DE Reg. 759 (02/01/22)*

#### **3210** Nursing Homes Admitting Pediatric Residents

##### **16 Del. Admin. Code § 3210-1.0** Purpose {#sec-3210-1.0 omnilex-key=us-de-regs-official--title-16--3210-1.0}

1.1 As set forth in 16 Del.C., Ch. 11 §1101:

1.1.1 the primary purpose of the licensing and regulation of nursing facilities and similar facilities is to ensure that these facilities provide a high quality of care and quality of life to their residents.î

1.1.2 Given that most nursing facilities and similar facilities provide services to adults who are elderly and/or physically disabled, children with special needs housed in these facilities require unique and carefully coordinated plans of pediatric care as well as developmentally appropriate, family-friendly environments.

1.1.3 These regulations outline minimum acceptable levels of care and treatment for this population.

1.1.4 A facility must be in compliance with all state and local laws and regulations applicable to facility personnel, provision of services and physical plant.

**History**
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *25 DE Reg. 760 (02/01/22)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *25 DE Reg. 760 (02/01/22)*

##### **16 Del. Admin. Code § 3210-2.0** Authority and Applicability {#sec-3210-2.0 omnilex-key=us-de-regs-official--title-16--3210-2.0}

2.1 These regulations are adopted in implementation of 16 Del.C. Ch. 11 and are applicable to any licensed nursing facility which provides care or services to one or more persons under 18 years of age.

2.2 These regulations are intended to supplement, and not supplant, general regulations promulgated in conformity with 16 Del.C. Ch. 11 and other applicable laws.

**History**
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *25 DE Reg. 760 (02/01/22)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *25 DE Reg. 760 (02/01/22)*

##### **16 Del. Admin. Code § 3210-3.0** Definitions {#sec-3210-3.0 omnilex-key=us-de-regs-official--title-16--3210-3.0}

“Adult Resident” - any person residing in the facility 18 years of age and older.

“Care Plan” - a specific document that includes, but is not limited to, identified resident-based goals and defined action steps for providing appropriate care and treatment.

“Certified Nursing Assistant” - an individual certified in accordance with 16 Del.C., Ch. 30A, under the supervision of a licensed nurse, who provides care which does not require the judgment and skills of a licensed nurse. The care may include, but is not limited to, the following: bathing, dressing, grooming, toileting, ambulating, transferring and feeding, observing and reporting the general well-being of the persons(s) to whom they are providing care.

“Department”- Department of Health and Social Services.

“Division”- Division of Health Care Quality.

“Licensee” - the person or organization to whom a license is granted and who has full legal authority and responsibility for the governance and operation of a nursing home and/or similar facility.

“Pediatric Resident” - any person residing in a nursing facility under 18 years of age and for whom there is a care plan including medical care, treatment and other related services.

“Primary Care Nurse (PCN)” - a Registered Nurse with at least a Bachelor’s Degree in nursing with expertise in the care of children with special needs. The PCN is responsible for the day to day delivery of all services specified in the care plan.

“Primary Care Provider (PCP)” - a physician licensed to practice in the State of Delaware with expertise in the care of children with special needs designated to coordinate medical care on a day to day basis.

“Social Worker” - an individual with a bachelor’s degree in social work or in a human services field including but not limited to sociology, special education, rehabilitation counseling, and psychology. An individual with a bachelor’s degree in any other related field may qualify if the individual can demonstrate competency in coordinating care for medically fragile populations either through course work or experience. A minimum of one year of supervised experience is required in a long term care setting working directly with individuals and their families.

**History**
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *25 DE Reg. 760 (02/01/22)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *25 DE Reg. 760 (02/01/22)*

##### **16 Del. Admin. Code § 3210-4.0** General Requirements {#sec-3210-4.0 omnilex-key=us-de-regs-official--title-16--3210-4.0}

4.1 Prior to admission, an interdisciplinary team of healthcare professionals shall evaluate the potential pediatric resident to determine whether the licensee can meet the pediatric resident’s needs. The care plan must contain documentation of the per-admission assessment with approval by the primary care provider and parents/guardian with notification to the responsible state agencies.

4.2 The licensee shall admit and retain only children with special needs whose specific medical, nursing, and psychosocial needs the licensee can meet.

4.3 The licensee through licensed healthcare professionals shall ensure that an interdisciplinary team is formulated for each pediatric resident. The interdisciplinary team shall include, but not be limited to, the Primary Care Nurse, a representative from each pediatric service received by the pediatric resident, a nutritionist, a representative from the educational program, social worker, Primary Care Provider and the parents/family/guardian. The team shall meet quarterly or more frequently as needed and review and document the care plan, and the Individual Education Plan (IEP) or Individualized Family Services Plan (IFSP) formulated for the pediatric resident.

**History**
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *25 DE Reg. 760 (02/01/22)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *25 DE Reg. 760 (02/01/22)*

##### **16 Del. Admin. Code § 3210-5.0** Facility Requirements {#sec-3210-5.0 omnilex-key=us-de-regs-official--title-16--3210-5.0}

5.1 Pediatric residents shall only share rooms with other residents of the same sex.

5.2 The licensee must provide a tobacco-free environment for pediatric residents.

5.3 The licensee must provide and maintain all clinically indicated pediatric resuscitation equipment for children with special needs. For rooms occupied by such children, oxygen, suction equipment and electrical outlets must be at each bedside with access to an emergency power system. A pediatric resuscitation cart shall be provided on each pediatric unit/wing and shall include: dosage appropriate emergency drugs, resuscitation equipment including a pediatric backboard for cardiopulmonary resuscitation (CPR), and an easily readable list of drug dosages. A defibrillator designed for pediatric use with paddle sizes appropriate for pediatric residents and an easily readable chart indicating jolt dosages must be provided on each pediatric unit/wing. Equipment must be in good working order and must be checked daily by a registered nurse for proper functioning and must be documented as such.

5.4 A nursing staff member certified in Pediatric Advanced Life Support (PALS) shall be present in the unit where pediatric residents reside and when pediatric residents are present.

5.5 All nurses caring for pediatric residents must be certified in infant and pediatric cardiopulmonary resuscitation (CPR).

5.6 An audio monitoring system shall be utilized whenever a pediatric resident is left unattended. The monitoring system must include heart rate and respiratory rate alarms audible to the nursing station. Any pediatric resident with a tracheotomy and/or ventilator must also be monitored by a pulse oximetry with alarms audible to the nursing station. The monitors must be used when pediatric residents are unsupervised and/or in their rooms for quiet time and nap/bed time. A plan to answer and respond to alarms must be in place and reviewed by all facility staff members.

5.7 The licensee through licensed healthcare professionals shall ensure that each pediatric resident is assessed by appropriate professionals for the need for assistive technology. The licensee shall ensure provision of appropriate assistive technology as prescribed as well as training in its use for staff members. Parents/family/guardian may also be trained when determined to be appropriate by the interdisciplinary team.

**History**
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *25 DE Reg. 760 (02/01/22)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *25 DE Reg. 760 (02/01/22)*

##### **16 Del. Admin. Code § 3210-6.0** Medical Services {#sec-3210-6.0 omnilex-key=us-de-regs-official--title-16--3210-6.0}

6.1 The licensee through licensed healthcare professionals shall ensure the delivery of individualized, comprehensive services to each pediatric resident in conformity with a care plan.

6.2 The PCN shall be the liaison among treating physicians.

6.3 Pediatric services must be multidisciplinary and individualized. The services provided to each pediatric resident must be developmentally specific and appropriate to the age group being served.

6.4 The licensee shall provide access to emergency medical care 24 hours a day, 7 days a week, as outlined in a written policy which is updated annually. The policy shall be reviewed with all staff members and mock situations performed and documented at least twice a year.

6.5 The licensee through licensed healthcare professionals shall ensure complete physical assessments are performed on pediatric residents by the PCP or a Primary Care Nurse on admission/readmission and monthly thereafter. Documentation of complete physical assessment must be included in the pediatric resident’s chart for review by all medical and nursing staff.

6.6 The licensee through licensed healthcare professionals shall ensure that each pediatric resident receives immunizations in accordance with current national pediatric standards.

6.7 The licensee through licensed healthcare professionals shall ensure timely medically necessary referrals to pediatric medical sub-specialists and pediatric surgical specialists as needed.

6.8 The licensee through licensed healthcare professionals shall ensure that each pediatric resident over the age of 3 years receives dental exams according to current national dentistry standards and necessary treatment.

**History**
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *25 DE Reg. 760 (02/01/22)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *25 DE Reg. 760 (02/01/22)*

##### **16 Del. Admin. Code § 3210-7.0** Therapy Services {#sec-3210-7.0 omnilex-key=us-de-regs-official--title-16--3210-7.0}

7.1 The licensee shall ensure that qualified individuals specializing in the healthcare of children with special needs (e.g., physical therapist, occupational therapist, speech therapist, nutritionist, qualified interpreter) plan and administer the treatments for each pediatric resident.

7.2 The licensee through licensed healthcare professionals shall ensure that the plan for therapy and progress toward goals is reviewed and revised at least quarterly and is incorporated into the care plan. The nature, duration, frequency, and provider of therapy services shall be specified in the care plan.

**History**
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *25 DE Reg. 760 (02/01/22)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *25 DE Reg. 760 (02/01/22)*

##### **16 Del. Admin. Code § 3210-8.0** Nutritional Services {#sec-3210-8.0 omnilex-key=us-de-regs-official--title-16--3210-8.0}

8.1 The licensee through licensed healthcare professionals shall ensure that each pediatric resident has an individually appropriate care plan that addresses the nutritional needs of that resident including the recommended daily allowance (RDA) of vitamins and minerals according to current national pediatric standards.

8.2 The licensee through licensed healthcare professionals shall ensure that infants and children are held during oral feeding as needed.

8.3 The licensee through licensed healthcare professionals shall consult with the PCP regarding the introduction of solid foods and the pediatric resident’s progress in advancing to table foods.

8.4 The licensee through licensed healthcare professionals shall ensure each pediatric resident is meeting his/her optimal developmental potential regarding eating habits/eating techniques.

8.5 The licensee through licensed healthcare professionals and support staff shall assist pediatric residents to convene in a common dining area and partake in social gatherings around meal times, including children who are fed by tube.

8.6 The licensee shall ensure proper documentation of meal intake every shift.

**History**
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *25 DE Reg. 760 (02/01/22)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *25 DE Reg. 760 (02/01/22)*

##### **16 Del. Admin. Code § 3210-9.0** Nursing Services {#sec-3210-9.0 omnilex-key=us-de-regs-official--title-16--3210-9.0}

9.1 The licensee shall ensure that at least one registered nurse is present on every shift. That nurse must have at least one year of previous employment in a pediatric setting. This nurse may be the Primary Care Nurse (PCN).

9.2 The licensee through licensed healthcare professionals shall ensure that a sufficient number of nursing staff are assigned to the pediatric care unit to provide care in accordance with each pediatric resident's care plan and to meet each pediatric resident’s needs. The licensee shall provide sufficient nursing and support staff so that each pediatric resident receives daily interaction from a variety of staff members. Interaction includes, but is not limited to, frequent conversation, play and holding/cuddling of pediatric residents to provide daily stimulation.

9.3 The licensee shall ensure that all pediatric nursing procedures are written in a policy and procedure manual. The manual must be accessible to all staff members caring for pediatric residents. Each individual policy must be reviewed and updated at least annually.

9.4 In addition to the facility standard orientation, the licensee shall ensure that upon hiring, all pediatric nursing and support staff complete an orientation to the pediatric unit/wing which is documented in the staff members’ personnel files.

9.5 The licensee shall ensure that each nursing and support staff member providing care to pediatric residents receives training and demonstrates competence prior to performing any specialized skill or procedure on a pediatric resident. Written evidence of training and demonstration of competence must be included in each nursing and support staff member’s personnel file.

9.6 The licensee through licensed healthcare professionals and support staff shall ensure that mouth care, skin care, passive range of motion, hygiene and other dependent care activities are performed as specified in the care plan.

**History**
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *25 DE Reg. 760 (02/01/22)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *25 DE Reg. 760 (02/01/22)*

##### **16 Del. Admin. Code § 3210-10.0** Educational Services {#sec-3210-10.0 omnilex-key=us-de-regs-official--title-16--3210-10.0}

10.1 The licensee in coordination with appropriate educational professionals shall ensure that each pediatric resident eligible for services under the Individuals with Disabilities Education Act (IDEA) is offered such services in conformity with 14 Del.C., Ch. 31 and 16 Del.C., Ch. 2, Subchapter II, and any regulations implemented under those laws.

10.2 The licensee shall maximize the coordination of each pediatric resident’s care plan with any Individual Education Plan (IEP) or Individual Family Service Plan (IFSP) to ensure consistency and promotion of the pediatric resident’s optimal benefit. In implementation of this duty, the PCN and Social Worker shall collaborate with responsible schools or school districts in development and revision of care plans, IEPs, and IFSPs.

**History**
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *25 DE Reg. 760 (02/01/22)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *25 DE Reg. 760 (02/01/22)*

##### **16 Del. Admin. Code § 3210-11.0** Family Services {#sec-3210-11.0 omnilex-key=us-de-regs-official--title-16--3210-11.0}

11.1 The Social Worker and other involved staff members shall promote positive family interaction and provide comprehensive instruction in providing care, as needed. The licensee shall have written guidelines for:

11.2 The Social Worker and other involved staff members shall ensure that family support services are provided which include, but are not limited to, transportation, health education, counseling/support groups, home visiting, and coordination of care. The provision of quality services shall be family-based, community-based and culturally appropriate.

11.3 The Social Worker shall provide assistance to families to obtain services including Social Security, Medicaid, and other public/private assistance programs.

11.4 The licensee through licensed healthcare professionals shall facilitate discharge planning and coordination of outside resources. The licensee shall encourage the option of discharging the pediatric resident to the home if resources are available and the family is willing.

**History**
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *25 DE Reg. 760 (02/01/22)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *25 DE Reg. 760 (02/01/22)*

##### **16 Del. Admin. Code § 3210-12.0** Emergency Preparedness {#sec-3210-12.0 omnilex-key=us-de-regs-official--title-16--3210-12.0}

12.1 Nursing facilities shall comply with the rules and regulations adopted and enforced by the State Fire Prevention Commission or the municipality with jurisdiction.

12.2 Regular fire drills shall be held at least quarterly on each shift. Written records shall be kept of attendance at such drills.

12.3 Each facility shall develop and maintain all-hazard emergency plans for evacuation and sheltering in place. The plan must be submitted to the Division and DEMA in a digital format and it must conform to the template prescribed by the Division.

12.4 The staff on all shifts shall be trained on emergency and evacuation plans. Evacuation routes shall be posted in a conspicuous place at each nursing station.

12.5 In the event of a facility evacuation, the evacuation plan shall, at a minimum, provide for the transfer or availability of resident medications and records.

12.6 Each facility shall submit with an application for a license and annual renewal of a license:

12.6.1 A current all hazards emergency plan, and

12.6.2 Copies of the FEMA certificate of achievement which demonstrates that at least two active, full-time employees have completed FEMA training in ICS-100 and NIMS-700a in the past 24 months.

12.7 The Division may grant an extension of time for either requirement in 12.6 upon request and for good cause shown.

**History**
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *25 DE Reg. 760 (02/01/22)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *25 DE Reg. 760 (02/01/22)*

##### **16 Del. Admin. Code § 3210-13.0** Miscellaneous Services {#sec-3210-13.0 omnilex-key=us-de-regs-official--title-16--3210-13.0}

13.1 The licensee shall ensure that each pediatric resident has adequate, clean, well-fitting clothing that is weather appropriate. Clothing must be used exclusively by one pediatric resident and not shared in common.

13.2 The licensee shall ensure that each pediatric resident has individual personal hygiene items that are in proper condition for use and are not shared for use with other residents. These items include, but are not limited to, bathing soap, toothbrush, toothpaste, hair brushes/comb, and other toiletries.

13.3 The licensee through licensed healthcare and educational professionals shall ensure that each pediatric resident engages in activities on a daily basis which directly relate to the following developmental areas:

13.4 The licensee shall ensure adequate staff to enable pediatric residents to participate in daily play activities and crafts. The licensee shall provide indoor and outdoor play and activity equipment that is appropriate for the ages and developmental levels of the pediatric residents.

13.5 The licensee shall provide recreational therapy for the pediatric residents which will include supervised outdoor activity and play time, weather permitting and the pediatric resident’s condition permitting.

13.6 The licensee though the Activities Director shall ensure that appropriate alternative recreational activities are provided for pediatric residents unable to participate in group activities.

13.7 The licensee shall ensure that all shared play equipment is properly disinfected and that needed infection control precautions are taken.

13.8 The licensee shall ensure that pediatric residents are transported in accordance with current national safety standards.

13.9 A registered nurse must accompany pediatric residents on all school-related field trips. Portable resuscitation equipment must be supplied and accompany the pediatric residents.

**History**
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *25 DE Reg. 760 (02/01/22)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *25 DE Reg. 760 (02/01/22)*

##### **16 Del. Admin. Code § 3210-14.0** Resuscitation Orders {#sec-3210-14.0 omnilex-key=us-de-regs-official--title-16--3210-14.0}

14.1 Upon admission to the facility, the PCP and PCN shall discuss with the parents/guardian of the pediatric resident procedures to follow in terms of a Do Not Resuscitate (DNR) status and shall include in the pediatric resident’s chart, documentation of either DNR or Full Code status.

14.2 The DNR status of a pediatric resident shall not prohibit full participation by that pediatric resident in school/recreational field trips and/or events.

**History**
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *25 DE Reg. 760 (02/01/22)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *25 DE Reg. 760 (02/01/22)*

##### **16 Del. Admin. Code § 3210-15.0** Waiver {#sec-3210-15.0 omnilex-key=us-de-regs-official--title-16--3210-15.0}

Waivers may be granted by the Division for good cause.

**History**
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *25 DE Reg. 760 (02/01/22)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *25 DE Reg. 760 (02/01/22)*

##### **16 Del. Admin. Code § 3210-16.0** Severability {#sec-3210-16.0 omnilex-key=us-de-regs-official--title-16--3210-16.0}

Should any section, sentence, clause or phrase of these regulations be legally declared unconstitutional or invalid for any reason, the remainder of said regulations shall not be affected thereby.

**History**
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *25 DE Reg. 760 (02/01/22)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *25 DE Reg. 760 (02/01/22)*

##### **16 Del. Admin. Code § 3210-17.0** Infection Prevention and Control Program {#sec-3210-17.0 omnilex-key=us-de-regs-official--title-16--3210-17.0}

17.1 The licensee shall establish and implement an infection prevention and control program which shall be based upon Centers for Disease Control and Prevention and other nationally recognized infection prevention and control guidelines.

17.1.1 The infection prevention and control program must cover all services and all areas of the facility, including provision of the appropriate personal protective equipment for all residents, staff, and visitors.

17.2 The individual designated to lead the licensee's infection prevention and control program must develop and implement a comprehensive plan that includes actions to prevent, identify, and manage infections and communicable diseases. The plan must include mechanisms that result in immediate action to take preventive or corrective measures that improve the licensee's infection control outcomes.

17.3 All licensee's staff shall receive orientation at the time of employment and annual in-service education regarding the infection prevention and control program.

17.4 Specific Requirements for COVID-19

17.4.1 Before their start date, all new staff, vendors and volunteers must be tested for COVID-19 in accordance with Division of Public Health guidance.

17.4.2 All staff, vendors and volunteers must be tested for COVID-19 in a manner consistent with Division of Public Health guidance.

17.4.3 The licensee must follow recommendations of the Centers for Disease Control and Prevention and the Division of Public Health regarding the provision of care or services to residents by staff, vendor or volunteer found to be positive for COVID-19 in an infectious stage.

17.5 The licensee shall amend their policies and procedures to include:

17.5.1 Work exclusion and return to work protocols for staff tested positive for COVID-19;

17.5.2 Staff refusals to participate in COVID-19 testing;

17.5.3 Staff refusals to authorize release of testing results or vaccination status to the licensee;

17.5.4 Procedures to obtain staff authorizations for release of laboratory test results to the licensee to inform infection control and prevention strategies; and

17.5.5 Plans to address staffing shortages and licensee demands should a COVID-19 outbreak occur.

**History**
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *25 DE Reg. 760 (02/01/22)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *5 DE Reg. 2126 (05/01/02)*
- *6 DE Reg. 79 (07/01/02)*
- *16 DE Reg. 863 (02/01/13)*
- *25 DE Reg. 760 (02/01/22)*

#### **3215** Training of Paid Feeding Assistants

##### **16 Del. Admin. Code § 3215-1.0** Introduction {#sec-3215-1.0 omnilex-key=us-de-regs-official--title-16--3215-1.0}

These regulations allow for the use of Paid Feeding Assistants, as single task workers, to provide feeding assistance in nursing facilities and assisted living facilities. To ensure consistency in the training of Feeding Assistants, the Division of Long Term Care Residents Protection has developed minimum requirements for Feeding Assistant training programs. Each Feeding Assistant training program shall be approved by the Division of Long Term Care Residents Protection. The intent of these regulations is to provide more residents with help in eating and drinking, or encouraging the resident so that more of the meal is consumed, making mealtime a more pleasant experience, and potentially reducing the incidence of unplanned weight loss and dehydration. The determination of which residents may receive assistance from a Feeding Assistant shall be based on the needs and potential risks to a resident as observed and documented in the resident’s plan of care and the comprehensive assessment of the resident’s functional capacity. While these regulations are not applicable to volunteers and family members, those individuals are encouraged to complete a Feeding Assistant training program.

**History**
- *7 DE Reg. 1186 (3/1/04)*

##### **16 Del. Admin. Code § 3215-2.0** Definitions {#sec-3215-2.0 omnilex-key=us-de-regs-official--title-16--3215-2.0}

“Division” The Division of Long Term Care Residents Protection.

“Feeding Assistant” An unlicensed, uncertified person trained to assist residents with nutrition and hydration who has successfully completed an initial training program and has demonstrated competency.

“Feeding Assistant Program” Policies and procedures established by a facility to provide supervision of Feeding Assistants, resident selection criteria, and implementation of Section 3.0 of these regulations.

“Instructors” Registered nurses, advanced practice nurses, dietitians, speech pathologists, or a combination of such professionals, who train Feeding Assistants. Occupational therapists may be defined as instructors for purposes of training in special needs as described in Section 3.0 of these regulations

“Resident” A person admitted to a nursing facility or assisted living facility licensed pursuant to 16 Del.C. Ch. 11.

“Student” A person enrolled in an approved Feeding Assistant training program.

“Supervision” Direct oversight by a registered nurse or licensed practical nurse who is in the unit or on the floor where feeding assistance is furnished.

“Supervisory Nurse” The nurse who is responsible for a specific area of a facility such as a floor or unit.

**History**
- *7 DE Reg. 1186 (3/1/04)*

##### **16 Del. Admin. Code § 3215-3.0** General Requirements {#sec-3215-3.0 omnilex-key=us-de-regs-official--title-16--3215-3.0}

3.1 Facilities implementing Feeding Assistant programs shall have written policies and procedures in place that include each item in Section 3.1.

3.2 Facilities implementing Feeding Assistant Programs shall strictly limit the responsibilities of each Feeding Assistant.

3.2.1 The facility shall ensure that each Feeding Assistant performs only those duties for which he/she has been specifically trained.

3.2.2 The facility shall ensure that each Feeding Assistant seeks assistance from other members of the resident care team for all resident needs other than nutrition/hydration.

3.3 Each Feeding Assistant employed by any facility either as facility or contract/agency staff shall be required to meet the following:

3.3.1 Each unlicensed or uncertified individual who feeds and hydrates residents in a facility, with the exception of family members and volunteers, shall successfully complete a Feeding Assistant training program approved by the Division of Long Term Care Residents Protection.

3.3.2 Feeding Assistants shall be required to successfully complete an approved Feeding Assistant training program before providing nutrition/hydration to residents.

3.3.3 A Feeding Assistant may provide nutrition/hydration to a resident only under the supervision of a registered nurse or licensed practical nurse who is present in the unit or on the floor where the task is performed and is readily available to provide assistance to the Feeding Assistant when needed.

3.3.4 A Feeding Assistant may provide nutrition/hydration only for those residents who have been assessed and approved by the supervisory nurse for such assistance. The resident assessment shall be based on the needs of, and potential risks to, the resident as observed and documented in the resident’s written plan of care and the latest comprehensive assessment of the resident’s functional capacity.

3.3.5 A Feeding Assistant shall not feed residents who are assessed to have complicated feeding problems such as recurrent lung aspirations, difficulty swallowing, feeding tubes, parenteral/IV feedings, chronic coughing or choking.

3.4 Participating facilities shall maintain records regarding the following:

3.4.1 The names of Feeding Assistants hired solely to provide nutrition and hydration.

3.4.2 The names of Feeding Assistants performing additional paid tasks in the facility.

3.4.3 The names of residents served by the Feeding Assistants.

3.5 The facility shall have policies and procedures in place to assure that Feeding Assistants report and record appropriate observations made while providing nutrition and hydration to nursing staff.

3.6 The resident’s record shall have documentation that the residents may be fed by a Feeding Assistant. Examples of such documentation include care plans, minimum data sets, uniform assessment instruments and flow charts.

3.7 The supervisory nurse shall request a physician referral to a speech pathologist for an assessment of a resident served by a Feeding Assistant when indicated, e.g., when there has been a change in the resident’s swallowing ability.

3.8 The facility shall maintain a list of facility staff qualified to train Feeding Assistants.

3.9 Feeding Assistants shall not be counted toward meeting any minimum staffing requirements.

**History**
- *7 DE Reg. 1186 (3/1/04)*

##### **16 Del. Admin. Code § 3215-4.0** Feeding Assistant Training Program Requirements {#sec-3215-4.0 omnilex-key=us-de-regs-official--title-16--3215-4.0}

4.1 General Training Requirements

4.1.1 Each Feeding Assistant training program shall be approved by the Division.

4.1.2 To obtain approval, the curriculum content for the Feeding Assistant training programs shall meet each of the following requirements:

4.1.2.1 The program shall be a minimum of 12 hours to include classroom instruction and demonstrated competency.

4.1.2.2 Classroom instruction and demonstrated competency in each requirement shall be completed prior to students providing resident nutrition/hydration. Programs shall maintain documentation of completion of requirements.

4.1.2.3 At the completion of training, each student who has satisfactorily completed a Feeding Assistant training program shall be provided with documentation of completion of a Delaware Feeding Assistant Program which shall be transferable among facilities with Feeding Assistant programs.

4.1.2.4 The instructor shall directly supervise students at all times while students are demonstrating competency.

4.1.2.5 Programs shall notify the Division in writing when changes to the program or the instructors are made.

4.2 Curriculum Content

4.2.1 Feeding Assistant Role and Function

4.2.1.1 On-the-job conduct, appearance, grooming, personal hygiene and ethical behavior.

4.2.1.2 Responsibilities and limitations of a Feeding Assistant.

4.2.1.2.1 A Feeding Assistant shall perform only those duties for which he/she has been specifically trained.

4.2.1.2.2 A Feeding Assistant shall seek assistance from other members of the resident care team for all resident needs other than nutrition/hydration.

4.2.1.3 Reporting and documenting incidents.

4.2.1.4 Knowledge of the “chain of command” in the facility.

4.2.1.5 Importance of punctuality and commitment to the job.

4.2.2 Resident Rights

4.2.2.1 Providing dignity and maintaining confidentiality.

4.2.2.2 Promoting the resident’s right to make personal choices to accommodate individual needs.

4.2.2.3 Maintaining care and security of resident’s personal possessions.

4.2.2.4 Providing care which ensures that the resident is free from abuse, mistreatment, neglect or financial exploitation.

4.2.3 Psychosocial Factors

4.2.3.1 Verbal and non-verbal communication and interpersonal skills with residents, including those with dementia.

4.2.3.2 Religious, ethnic and personal food preferences.

4.2.4 Appropriate Responses to Resident Behaviors

4.2.4.1 Identifying behaviors which require assistance from professional staff.

4.2.4.2 Recognizing and reporting changes in residents that are inconsistent with their normal behavior.

4.2.4.3 Distinguishing between normal eating and drinking behaviors and those which need to be reported.

4.2.5 Safety and Emergency Procedures

4.2.5.1 Recognizing emergencies which require assistance from other members of the resident care team.

4.2.5.2 Learning appropriate use of the resident call system.

4.2.5.3 Identifying when a resident is choking.

4.2.5.4 Learning how to perform the Heimlich maneuver.

4.2.6 Nutrition/Hydration

4.2.6.1 Understanding of therapeutic diets, supplements and dietary restrictions, including consistency restrictions.

4.2.6.2 Understanding of fluid needs and restrictions.

4.2.6.3 Understanding tips to encourage intake.

4.2.6.4 Understanding of food substitution policy.

4.2.6.5 Understanding use of special feeding devices, including use of straws when deemed appropriate and beneficial to a resident.

4.2.6.6 Understanding the components of a healthy diet.

4.2.6.7 Understanding factors that cause higher risk for nutrition and hydration problems.

4.2.7 Infection Control

4.2.7.1 Knowledge of proper hand washing and hygiene.

4.2.7.2 Knowledge of disease transmission and infection prevention.

4.2.8 Monitoring and Reporting Intake

4.2.8.1 Fluids

4.2.8.1.1 Identifying amounts consumed according to facility policy and procedures.

4.2.8.1.2 Identifying items that are liquid or classified as liquid.

4.2.8.1.3 Recording liquid intake accurately.

4.2.8.2 Foods

4.2.8.2.1 Identifying percentage of food consumed according to facility policy and procedure.

4.2.8.2.2 Recording amount eaten accurately.

4.2.8.2.3 Reporting food-related resident problems.

4.3 Competencies

4.3.1 Feeding Techniques

4.3.1.1 Check resident’s identification and diet card to ensure that resident has received the correct tray.

4.3.1.2 Provide resident with napkin and clothing protector, as needed.

4.3.1.3 Describe selection and location of foods on tray.

4.3.1.4 Assist resident with food preparation, as needed.

4.3.1.5 Observe to make sure each mouthful of food is swallowed before more is ingested.

4.3.1.6 Offer liquids at intervals with solid food.

4.3.1.7 Record food and fluid intake separately and accurately.

4.3.2 Social/Environmental Factors

4.3.2.1 Encourage resident to eat independently, if appropriate.

4.3.2.2 Provide cuing and prompting during meals as needed.

4.3.2.3 Make pleasant conversation, but refrain from asking questions while the resident has food in his/her mouth or asking questions that require lengthy answers.

4.3.2.4 Never rush the resident while feeding.

4.3.2.5 Sit next to the resident to convey an unhurried feeling.

4.3.2.6 Keep the resident focused on eating. Avoid distractions.

4.3.2.7 Be aware of infection control techniques, including avoidance of blowing on hot food and sharing or sampling resident’s meal.

4.3.3 Special Needs

4.3.3.1 Use hand on hand to assist resident, as needed.

4.3.3.2 Help resident to grasp eating utensils and beverage containers.

4.3.3.3 Help resident with assistive devices such as plate guards and adaptive eating utensils.

**History**
- *7 DE Reg. 1186 (3/1/04)*

#### **3220** Training and Qualifications for Certified Nursing Assistants

##### **16 Del. Admin. Code § 3220-1.0** Definitions {#sec-3220-1.0 omnilex-key=us-de-regs-official--title-16--3220-1.0}

"Activities of Daily Living (ADLs)" means normal daily activities including but not limited to ambulating, transferring, range of motion, grooming, bathing, dressing, eating and toileting.

"Advanced Practice Nurse" means an individual whose education and licensure meet the criteria outlined in 24 Del.C. Ch. 19.

"Certified Nursing Assistant (CNA)" means a duly certified individual under the supervision of a nurse, who provides care which does not require the judgment and skills of a nurse.

"Chemical Restraint" means psychopharmacologic drugs that are used for discipline or convenience and not required to treat medical symptoms.

"Department" means the Department of Health and Social Services.

"Direct Supervision" means actually observing students performing tasks.

“Facility" means a Nursing Facility, Assisted Living Facility or Intermediate Care Facility for Persons with Intellectual Disabilities licensed pursuant to 16 Del.C. Ch. 11.

"Full-Time" means working a minimum of 35 clock hours per week.

"General Supervision" means providing necessary guidance for the program and maintaining ultimate responsibility.

"Nurse" means a licensed practical nurse (LPN), registered nurse (RN) and/or advanced practice nurse (APRN) whose education and licensure meet the criteria in 24 Del.C. Ch. 19.

"Nursing Related Services" means services that include but are not limited to the following: bathing, dressing, grooming, toileting, ambulating, transferring and feeding, observing and reporting the general well-being of the person(s) to whom a qualified person is providing care.

"Physical Restraint" means any manual method or physical or mechanical device, material or equipment attached or adjacent to the resident's/patient's body that the individual cannot remove easily which restricts freedom of movement or normal access to one's body.

"Resident/Patient" means a person residing in a facility licensed pursuant to 16 Del.C. Ch. 11 or a person receiving care in a licensed acute or outpatient healthcare setting.

"Student" means a person enrolled in a course offering certification as a CNA.

**History**
- *26 DE Reg. 107 (08/01/22)*
- *26 DE Reg. 107 (08/01/22)*
- *26 DE Reg. 107 (08/01/22)*
- *26 DE Reg. 107 (08/01/22)*
- *26 DE Reg. 107 (08/01/22)*
- *26 DE Reg. 107 (08/01/22)*
- *5 DE Reg. 1908 (04/01/02)*
- *6 DE Reg. 1505 (05/01/03)*
- *8 DE Reg. 1014 (01/01/05)*
- *14 DE Reg. 169 (09/01/10)*
- *15 DE Reg. 192 (08/01/11)*
- *15 DE Reg. 1010 (01/01/12)*
- *16 DE Reg. 632 (12/01/12)*
- *20 DE Reg. 901 (05/01/17)*
- *26 DE Reg. 107 (08/01/22)*

##### **16 Del. Admin. Code § 3220-2.0** Requirements and Procedures for CNA Certification {#sec-3220-2.0 omnilex-key=us-de-regs-official--title-16--3220-2.0}

2.1 Initial certification

2.1.1 To be eligible to take the examination for certification for CNA, the applicant must be a graduate of a Department approved program for CNA.

2.1.2 A certificate of completion must be issued from the approved program before filing an application for testing.

2.1.2.1 The certificate of completion must be dated within 24 months of the testing date.

2.1.2.2 Certificates of completion older than 24 months are no longer valid.

2.1.3 An application for testing shall be filed, along with a non-refundable fee, with the test vendor approved by the Department.

2.1.4 Students must take and pass both the written and clinical portions of the competency test to become certified.

2.1.5 Students who fail to obtain a passing score may repeat the test two additional times.

2.1.5.1 Students who fail to obtain a passing score after testing three times must repeat the CNA training program before retaking the test.

2.1.6 Nursing students who are currently enrolled in a nursing program will be deemed to meet the CNA educational requirements provided they have:

2.1.6.1 Satisfactorily completed a Fundamentals/Basic Nursing course and

2.1.6.2 Satisfactorily completed a specific number of hours of supervised clinical practicum in either a facility or a hospital licensed pursuant to 16 Del.C. Ch. 10 setting, under the direct supervision of a nurse. The total clock hours of clinical training required for certification shall be determined by the Department through written order signed by the Secretary. At no time may the number of clock hours be less than those required by the Centers for Medicare and Medicaid Services.

2.1.6.3 Nursing students will be approved to take the CNA competency test upon submission of a letter from their school of nursing attesting to current enrollment status and a transcript showing satisfactory course completion as described.

2.1.7 Individuals who have graduated from an RN or LPN program in the United States:

2.1.7.1 Within 24 months prior to application for certification are deemed qualified to meet the Department's nurse aide training and competency evaluation program requirements and are eligible for certification upon submission of a sealed copy of their diploma.

2.1.7.2 More than 24 months prior to application for certification are deemed qualified to meet the Department's nurse aide training program requirements and are eligible to take the competency test upon submission of a sealed copy of their diploma.

2.1.8 Foreign trained nurses are eligible to sit for the state competency test if they meet the following requirements:

2.1.8.1 The nurse must have been issued a certificate of licensure by the licensing agency in the state, territory or country where the nursing program is located.

2.1.8.2 The nurse must submit a certificate issued by the Commission on Graduates of Foreign Nursing Schools or other Board of Nursing approved agency as evidence of the educational requirements of a curriculum for the preparation of professional nurses which is equivalent to the approved professional schools in Delaware.

2.1.8.3 The nurse must submit official English translations of all required credentials.

2.1.9 CNA certification shall be granted, for a period of 2 years (24 months) to all CNAs who meet the requirements.

2.2 Reciprocity

2.2.1 Delaware CNA certification is required prior to being employed as a CNA in the State.

2.2.2 A CNA trained and certified in a State other than Delaware must have completed a program that equals or exceeds the federal nurse aide training program requirements in the Code of Federal Regulations §483.152.

2.2.3 The Department will grant reciprocity to the out-of-state applicant provided the CNA:

2.2.3.1 Has a current CNA certificate from the jurisdiction where he or she currently practices.

2.2.3.1.1 Applicants from the State of Maryland must hold a current Geriatric Nursing Assistant certificate.

2.2.3.2 Within the last 24 months, has completed 3 months of full-time experience, equal to 420 clock hours, as a CNA performing nursing related services for pay under the supervision of a nurse or physician, or has completed a training and competency evaluation program with the number of hours at least equal to that required by the State of Delaware.

2.2.3.3 Is in good standing in the jurisdiction where he/she is currently certified.

2.2.3.4 Has submitted the required reciprocity fee along with the application.

2.2.4 CNA certification shall be granted, for a period of 2 years (24 months) to all CNAs who meet the requirements.

2.3 Certification Renewal

2.3.1 CNA certification shall be effective for 2 years following the date of issue and shall expire 2 years following such date, unless it is suspended, revoked, or surrendered prior to the expiration date.

2.3.2 CNAs must apply for certification renewal at least 30 days prior to the expiration date of the certification.

2.3.2.1 The required renewal fee must accompany the application for renewal.

2.3.2.2 The CNA must be able to prove that he/she has completed the requirements outlined in subsection 2.3.4.

2.3.3 A certification renewal will not be issued to a CNA who has not completed the requirements for renewal as outlined in subsection 2.3.4 and/or has not submitted an application for renewal and/or has not submitted the renewal fee.

2.3.4 In order to qualify for recertification, a CNA must complete the following during each 24 month certification period and prior to certification expiration:

2.3.4.1 24 hours of Department approved continuing education which must include:

2.3.4.1.1 Six (6) hours of dementia training and

2.3.4.1.2 Two (2) hours of resident/patient abuse/neglect/mistreatment prevention training.

2.3.4.2 Perform at least 64 hours of nursing related services for pay under the supervision of a nurse.

2.3.5 A CNA who fails to complete the requirements outlined in subsection 2.3.4 must take and pass the competency test again.

2.3.5.1 Payment of the testing fee is required when applying to take the competency test.

2.3.6 A CNA who fails to renew the certification prior to the expiration date but has completed the requirements outlined in subsection 2.3.4 may still renew the certification up to 30 days past the certification's expiration.

2.3.6.1 A late payment fee of $25.00 (in addition to the renewal fee) must be submitted with the renewal application.

2.3.7 The certification of any CNA who is on active military duty with the armed forces of the United States and serving in a theater of hostilities on the date that recertification is due shall be deemed to be current and in full compliance with this chapter until the expiration of 30 days after such CNA is no longer on active military duty in a theater of hostilities.

2.3.8 The certification of a CNA who fails to renew on time or during the 30-day late renewal period is considered lapsed.

2.3.8.1 A CNA with a lapsed certification is not permitted to work as a CNA in the State of Delaware.

2.3.8.2 The CNA must take and pass the CNA competency test in order to work as a CNA in the State of Delaware.

2.3.9 Individuals who fail to obtain a passing score on the written and/or clinical portions of the competency test after testing three times must repeat the CNA training program before additional testing will be permitted.

2.3.10 A CNA, who is certified in Delaware, may not use the certification from another State for the purpose of applying for reciprocity to avoid Delaware's continuing education requirements.

**History**
- *26 DE Reg. 107 (08/01/22)*
- *26 DE Reg. 107 (08/01/22)*
- *26 DE Reg. 107 (08/01/22)*
- *26 DE Reg. 107 (08/01/22)*
- *26 DE Reg. 107 (08/01/22)*
- *26 DE Reg. 107 (08/01/22)*
- *5 DE Reg. 1908 (04/01/02)*
- *6 DE Reg. 1505 (05/01/03)*
- *8 DE Reg. 1014 (01/01/05)*
- *14 DE Reg. 169 (09/01/10)*
- *15 DE Reg. 192 (08/01/11)*
- *15 DE Reg. 1010 (01/01/12)*
- *16 DE Reg. 632 (12/01/12)*
- *20 DE Reg. 901 (05/01/17)*
- *26 DE Reg. 107 (08/01/22)*

##### **16 Del. Admin. Code § 3220-3.0** CNA Training Program Requirements {#sec-3220-3.0 omnilex-key=us-de-regs-official--title-16--3220-3.0}

3.1 Program approval must be obtained from the Department prior to operating a CNA program.

3.2 All training must be done by or under the general supervision of an RN.

3.2.1 The RN must possess a minimum of two years of RN experience, at least 1 year of which must be in the provision of nursing home facility services that meets federal skilled nursing home requirements.

3.2.1.1 The required one year of full-time nursing facility experience can be met by work experience in, or supervision or teaching of students, in a Delaware licensed nursing facility.

3.2.1.2 The RN supervisor shall:

3.2.1.2.1 Be available to all instructors;

3.2.1.2.2 Assist in developing lesson plans based on experience in taking care of nursing facility residents;

3.2.1.2.3 Ensure that instructors are qualified and proficient in teaching the CNA curriculum;

3.2.1.2.4 Evaluate and document the proficiency of instructor every 6 months; and

3.2.1.2.5 Ensure that the program is operating in accordance with all state and federal regulations.

3.3 All instructors (classroom and clinical) must have:

3.3.1 Completed a Department approved course in teaching adults; or

3.3.2 Experience teaching adults in a group classroom/clinical setting; or

3.3.3 In the case of high school programs, met the requirements for teaching as required by the Department of Education.

3.4 LPN instructors can assist the supervising RN instructors in laboratory skills, but are otherwise limited to instruction of students during the clinical phase of the CNA training program.

3.4.1 LPN instructors must have at least three years of LPN experience; and

3.4.2 LPN instructors must work under the general supervision of an RN.

3.5 Clinical instructors shall provide general supervision of students at all times during clinical instruction.

3.5.1 Clinical instructors shall provide direct supervision to students in the clinical setting while the student is learning a competency until proficiency has been both demonstrated and documented.

3.6 Personnel from other health professions may assist the nurse instructor as supplemental personnel.

3.6.1 Supplemental personnel must have at least 1 year of experience in their respective fields.

3.6.2 Supplemental personnel may include: RNs, LPNs, pharmacists, dieticians, social workers, sanitarians, fire safety experts, nursing home administrators, gerontologists, psychologists, physical and occupational therapists, activity specialist, speech/language/hearing therapists, resident/patient rights experts and others.

3.7 Programs must notify the Department in writing at least 30 days prior to implementing permanent and/or substantial changes to the program or the program's personnel.

3.7.1 Substantial changes include, but are not limited to: instructor(s), clinical or classroom site, major revision of course structure, change in textbook.

3.7.2 The program may request a waiver of the 30-day time period for good cause.

3.8 Classroom ratios of student to instructor shall not exceed 24:1.

3.9 Clinical and laboratory ratios of student to RN or LPN instructor shall not exceed 8:1.

3.10 Minimum equipment required:

3.10.1 Audio/Visual

3.10.2 Teaching Mannequin, Adult, for catheter and perineal care

3.10.3 Hospital Bed

3.10.4 Bedpan/Urinal

3.10.5 Bedside commode

3.10.6 Wheelchair

3.10.7 Scale

3.10.8 Overbed Table

3.10.9 Sphygmomanometer

3.10.10 Stethoscope

3.10.11 Resident/patient gowns, linens and at least four (4) pillows

3.10.12 Thermometers

3.10.13 Crutches

3.10.14 Canes (Variety)

3.10.15 Walker

3.10.16 Gait Belt

3.10.17 Miscellaneous supplies: i.e., bandages, compresses, heating pad, hearing aid, dentures, toothbrushes, razors, bath and emesis basins and compression stockings.

3.10.18 Foley Catheter and Drainage Bag

3.10.19 Mechanical lift

3.10.20 Adaptive eating utensils/equipment

3.10.21 Personal protective equipment

3.11 Curriculum Content and Competencies

3.11.1 The curriculum content for the CNA training programs shall meet each of the following requirements:

3.11.1.1 The material will provide a basic level of both knowledge and demonstrable skills for each individual completing the program.

3.11.1.2 The total, minimum clock hours of classroom instruction and clinical training required for certification shall be determined by the Department through written order signed by the Department Secretary. At no time may the number of clock hours be less than those required by the Centers for Medicare and Medicaid Services.

3.11.1.2.1 Additional hours may be added by the training program in either or both of the classroom instruction or clinical training components.

3.11.2 Specific curriculum content and expected competencies are outlined in APPENDIX A.

3.12 Students must master each skill competency as observed by the RN instructor prior to performing the skill on a resident/patient in a nursing facility. All demonstrable competencies for each student must be documented by the RN instructor as the competency is mastered by the student in order for a student to qualify as successfully having completed that section of programming.

3.13 A student may not work in a facility as a CNA until he/she has completed a CNA training program and passed the CNA competency test.

3.14 Immunizations requirements

3.14.1 The provisions of the State of Delaware, Department of Education, 14 DE Admin. Code 804, are hereby adopted as the regulatory requirements for CNA Training programs in Delaware and are hereby referred to, and made part of this regulation, as if full set out herein.

3.14.2 The provisions of the State of Delaware, Department of Health and Social Services, Division of Public Health, 16 DE Admin. Code 4202 are hereby adopted as the regulatory requirements for CNA Training programs in Delaware and are hereby referred to, and made part of this regulation, as if fully set out herein.

3.14.3 Students that do not meet the minimum vaccination requirements shall not be permitted to participate in clinical training.

3.15 Minimum requirements for tuberculosis (TB) testing of clinical instructors and students are those currently recommended by the Centers for Disease Control and Prevention of the U.S. Department of Health and Human Services:

3.15.1 A baseline testing must be completed before providing clinical services and, thereafter, as determined by a TB risk assessment.

3.15.2 No person found to have active TB in an infectious stage shall be permitted to participate in clinical training.

3.15.3 Any person having a positive skin test, but a negative chest X-ray must complete a statement annually attesting that they have experienced no symptoms which may indicate active TB infection.

**History**
- *26 DE Reg. 107 (08/01/22)*
- *26 DE Reg. 107 (08/01/22)*
- *26 DE Reg. 107 (08/01/22)*
- *26 DE Reg. 107 (08/01/22)*
- *26 DE Reg. 107 (08/01/22)*
- *26 DE Reg. 107 (08/01/22)*
- *5 DE Reg. 1908 (04/01/02)*
- *6 DE Reg. 1505 (05/01/03)*
- *8 DE Reg. 1014 (01/01/05)*
- *14 DE Reg. 169 (09/01/10)*
- *15 DE Reg. 192 (08/01/11)*
- *15 DE Reg. 1010 (01/01/12)*
- *16 DE Reg. 632 (12/01/12)*
- *20 DE Reg. 901 (05/01/17)*
- *26 DE Reg. 107 (08/01/22)*

##### **16 Del. Admin. Code § 3220-4.0** Mandatory Orientation Period {#sec-3220-4.0 omnilex-key=us-de-regs-official--title-16--3220-4.0}

4.1 Nursing Facilities General Requirements

4.1.1 All CNAs hired to work in a facility shall undergo a minimum number of clock hours of orientation. The requirements for certified nursing assistant orientation shall be specified by the Department in a written order signed by the Secretary.

4.1.2 Any CNA undergoing orientation may be considered a facility employee for purposes of satisfying the minimum facility staffing requirements. Orientation may also be considered as part of the 64 hour work requirement for certification renewal.

4.1.3 If a CNA who is not employed, or does not have an offer to be employed as a CNA, becomes employed by, or receives an offer of employment from a federally certified nursing facility not later than 12 months after completing a nurse aide training and competency evaluation program, the federally certified nursing facility shall reimburse all documented personally incurred costs in completing the CNA Training program.

4.1.3.1 Facilities shall accept as documentation: canceled checks, paid receipts, written verification from a training program or other written evidence which reasonably establishes the CNA's personally incurred costs.

4.1.3.2 Such costs include tuition, tests taken and fees for textbooks or other required course materials.

4.1.3.3 Such costs shall be reimbursed in equal quarterly payments with full reimbursement to coincide with the CNA's completion of one year of employment including the orientation period.

4.1.3.4 Any nursing facility which reimburses a CNA for documented personally incurred costs of a nurse aide training and competency evaluation program shall notify the Department of such reimbursement.

4.1.3.5 Notice of such reimbursement shall be entered in the CNA Registry database and information regarding such reimbursement shall be available to facilities upon request.

4.2 Orientation Program Requirements

4.2.1 The mandatory orientation program shall be under the supervision of a nurse and must include:

4.2.1.1 Tour of the facility and assigned residents' rooms

4.2.1.2 Fire and disaster plans

4.2.1.3 Emergency equipment and supplies

4.2.1.4 Communication (including the facility chain of command) and documentation requirements

4.2.1.5 Process for reporting emergencies, change of condition and shift report

4.2.1.6 Operation of facility equipment and supplies, including scales, lifts, special beds and tubs

4.2.1.7 Review of the plan of care for each assigned resident/patient including:

4.2.1.7.1 ADL/personal care needs

4.2.1.7.2 Nutrition, hydration and feeding techniques and time schedules

4.2.1.7.3 Bowel and bladder training programs

4.2.1.7.4 Infection control procedures

4.2.1.7.5 Safety needs

4.2.1.8 Role and function of the CNA

4.2.1.9 Resident/patient rights; abuse reporting

4.2.1.10 Safety and body mechanics; transfer techniques

4.2.1.11 Vital signs

4.2.1.12 Psychosocial needs

4.2.1.13 Facility policies and procedures

4.3 Temporary Agency Requirements

4.3.1 All CNAs employed by temporary agencies and placed in a facility in which they have not worked within the previous 6 months shall undergo a minimum of 2 hours of orientation prior to beginning their first shift at the facility.

4.3.2 Any CNA employed by a temporary agency and undergoing orientation shall not be considered a facility employee for purposes of satisfying the minimum facility staffing requirements.

4.3.3 The mandatory two-hour orientation program shall be under the supervision of a nurse and must include:

4.3.3.1 Tour of the facility and assigned resident/patient rooms

4.3.3.2 Fire and disaster plans

4.3.3.3 Emergency equipment and supplies

4.3.3.4 Communication and documentation requirements

4.3.3.5 Process for reporting emergencies, change of condition and shift report

4.3.3.6 Operation of facility equipment and supplies including but not limited to scales, lifts, special beds and tubs

4.3.3.7 Review of the plan of care for each assigned resident/patient including:

4.3.3.7.1 ADL/personal care needs

4.3.3.7.2 Nutrition, hydration and feeding techniques and time schedules

4.3.3.7.3 Bowel and bladder training programs

4.3.3.7.4 Infection control procedures

4.3.3.7.5 Safety needs

**History**
- *26 DE Reg. 107 (08/01/22)*
- *26 DE Reg. 107 (08/01/22)*
- *26 DE Reg. 107 (08/01/22)*
- *26 DE Reg. 107 (08/01/22)*
- *26 DE Reg. 107 (08/01/22)*
- *26 DE Reg. 107 (08/01/22)*
- *5 DE Reg. 1908 (04/01/02)*
- *6 DE Reg. 1505 (05/01/03)*
- *8 DE Reg. 1014 (01/01/05)*
- *14 DE Reg. 169 (09/01/10)*
- *15 DE Reg. 192 (08/01/11)*
- *15 DE Reg. 1010 (01/01/12)*
- *16 DE Reg. 632 (12/01/12)*
- *20 DE Reg. 901 (05/01/17)*
- *26 DE Reg. 107 (08/01/22)*

##### **16 Del. Admin. Code § 3220-5.0** Discipline {#sec-3220-5.0 omnilex-key=us-de-regs-official--title-16--3220-5.0}

5.1 Reasons for Disciplinary Action Include but are not limited to:

5.1.1 A conviction or substantiation of a crime or offense relating to the provision of care/services in a court of law.

5.1.2 Behavior that fails to conform to legal and accepted healthcare standards and thus may adversely affect the health and welfare of a resident/patient.

5.1.3 Performing acts beyond the authorized scope of the CNA.

5.1.4 Inaccurately and willfully recording, falsifying, or altering a resident/patient or agency/facility record related to care provision.

5.1.5 Abuse, neglect, mistreatment or financial exploitation of a resident/patient.

5.1.6 Leaving a resident/patient assignment except in documented emergency situations.

5.1.7 Failing to safeguard resident/patient dignity and right to privacy when providing services.

5.1.8 Violating the confidentiality of information concerning residents/patients.

5.1.9 Performing CNA duties when unfit to perform procedures and make decisions because of physical or mental impairment or dependence on alcohol or drugs.

5.1.10 Practicing as a CNA with an expired certification.

5.1.11 Allowing another person to use her/his CNA certification or impersonating another person holding a certificate,

5.1.12 Committing fraud, misrepresentation or deceit in taking the CNA test or in obtaining certification.

5.1.13 Failing to comply with the requirements for mandatory continuing education.

5.1.14 Failing to take appropriate action or follow policies and procedures designed to safeguard the resident/patient.

5.1.15 Having a certificate revoked or suspended in another state for reasons which would preclude certification in this state.

5.1.16 Failing to report abuse, neglect, mistreatment or financial exploitation of a resident/patient.

5.2 Types of Disciplinary Action

5.2.1 Refusal to issue a certification.

5.2.2 Revocation or suspension of a certification.

5.2.3 Issuance of a letter of reprimand.

5.2.4 Refusal to renew a certification.

5.2.5 Placement on the Adult Abuse Registry.

5.2.6 Flag on the CNA Registry.

5.3 Administrative Hearings

5.3.1 All hearings shall be conducted in accordance with the Administrative Procedures Act, 29 Del.C. Ch. 101.

5.3.2 A CNA for whom disciplinary action is recommended shall be notified by certified mail at his/her home address of the disciplinary action that shall be imposed.

5.3.3 A CNA for whom disciplinary action is recommended shall be offered a right to an administrative hearing.

5.3.4 All requests for an administrative hearing must be received in writing, postmarked within 20 calendar days of the date of the notice of disciplinary action.

5.3.5 Failure to request an administrative hearing within the appropriate timeframe will lead to imposition of the disciplinary action.

5.3.6 Procedural rights. The parties shall be given the opportunity to:

5.3.6.1 Examine, at a reasonable time before the date of the hearing and during the hearing, all documents and records to be used by either party at the hearing;

5.3.6.2 Bring witnesses;

5.3.6.3 Establish all pertinent facts and circumstances;

5.3.6.4 Present an argument without undue interference;

5.3.6.5 Question or refute any testimony or evidence, including the opportunity to confront and cross-examine adverse witnesses; and

5.3.6.6 Be represented by an attorney of the individual’s choice.

5.3.7 Hearing decisions must be based exclusively on evidence introduced at the hearing.

5.3.8 The record must consist only of:

5.3.8.1 The transcript or recording of testimony and exhibits;

5.3.8.2 All papers and requests filed in the proceeding; and

5.3.8.3 The decision of the hearing officer.

5.3.9 The impartial decision must:

5.3.9.1 Summarize the facts;

5.3.9.2 Identify the regulations pertinent to the decision; and

5.3.9.3 Specify the reasons for the decisions.

5.3.10 The hearing officer shall:

5.3.10.1 Render a written decision within thirty business days of the hearing and notify the individual and the Department.

5.3.10.2 Notify the parties that this is the final decision of the Department with the right to an appeal pursuant to the Administrative Procedures Act, 29 Del.C. Ch. 101.

APPENDIX A

MODULE: The Nursing Assistant Role and Function

COMPETENCIES:

MODULE: Environmental Needs of the Resident/Patient

COMPETENCIES:

MODULE: Psychosocial Needs of the Resident/Patient

COMPETENCIES:

MODULE: Physical Needs of the Resident/Patient

COMPETENCIES:

**History**
- *26 DE Reg. 107 (08/01/22)*
- *26 DE Reg. 107 (08/01/22)*
- *26 DE Reg. 107 (08/01/22)*
- *26 DE Reg. 107 (08/01/22)*
- *26 DE Reg. 107 (08/01/22)*
- *26 DE Reg. 107 (08/01/22)*
- *5 DE Reg. 1908 (04/01/02)*
- *6 DE Reg. 1505 (05/01/03)*
- *8 DE Reg. 1014 (01/01/05)*
- *14 DE Reg. 169 (09/01/10)*
- *15 DE Reg. 192 (08/01/11)*
- *15 DE Reg. 1010 (01/01/12)*
- *16 DE Reg. 632 (12/01/12)*
- *20 DE Reg. 901 (05/01/17)*
- *26 DE Reg. 107 (08/01/22)*

#### **3225** Assisted Living Facilities

##### **16 Del. Admin. Code § 3225-1.0** Purpose {#sec-3225-1.0 omnilex-key=us-de-regs-official--title-16--3225-1.0}

The Department of Health and Social Services is issuing these regulations to promote and ensure the health, safety, and well-being of all residents of assisted living facilities. These regulations are also meant to ensure that service providers will be accountable to their residents and the Department, and to differentiate assisted living care from skilled nursing care. The essential nature of assisted living is to offer living arrangements to medically stable persons who do not require skilled nursing services and supervision. The regulations establish the minimal acceptable level of services for residents of assisted living facilities.

**History**
- *8 DE Reg. 85 (07/01/04)*
- *15 DE Reg. 81 (07/01/11)*
- *15 DE Reg. 1156 (02/01/12)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*
- *8 DE Reg. 85 (07/01/04)*
- *13 DE Reg. 1328 (04/01/10)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 192 (08/01/11)*
- *15 DE Reg. 81 (07/01/11)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 81 (07/01/11)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 81 (07/01/11)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*
- *13 DE Reg. 1328 (04/01/10)*
- *13 DE Reg. 1328 (04/01/10)*
- *8 DE Reg. 85 (07/01/04)*
- *16 DE Reg. 865 (02/01/13)*
- *24 DE Reg. 579 (12/01/20)*
- *8 DE Reg. 85 (07/01/04)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 1156 (02/01/12)*
- *6 DE Reg. 525 (10/01/02)*
- *14 DE Reg. 1190 (05/01/11)*
- *15 DE Reg. 81 (07/01/11)*
- *15 DE Reg. 1156 (02/01/12)*
- *16 DE Reg. 865 (02/01/13)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*

##### **16 Del. Admin. Code § 3225-2.0** Authority and Applicability {#sec-3225-2.0 omnilex-key=us-de-regs-official--title-16--3225-2.0}

These regulations are promulgated in accordance with 16 Del.C. Ch. 11 and shall apply to any facility providing assisted living to elderly individuals or adults with disabilities. The term “assisted living” shall not be used as part of the official name of any facility in this State unless the facility has been so licensed by the Department of Health and Social Services.

**History**
- *8 DE Reg. 85 (07/01/04)*
- *15 DE Reg. 81 (07/01/11)*
- *15 DE Reg. 1156 (02/01/12)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*
- *8 DE Reg. 85 (07/01/04)*
- *13 DE Reg. 1328 (04/01/10)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 192 (08/01/11)*
- *15 DE Reg. 81 (07/01/11)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 81 (07/01/11)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 81 (07/01/11)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*
- *13 DE Reg. 1328 (04/01/10)*
- *13 DE Reg. 1328 (04/01/10)*
- *8 DE Reg. 85 (07/01/04)*
- *16 DE Reg. 865 (02/01/13)*
- *24 DE Reg. 579 (12/01/20)*
- *8 DE Reg. 85 (07/01/04)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 1156 (02/01/12)*
- *6 DE Reg. 525 (10/01/02)*
- *14 DE Reg. 1190 (05/01/11)*
- *15 DE Reg. 81 (07/01/11)*
- *15 DE Reg. 1156 (02/01/12)*
- *16 DE Reg. 865 (02/01/13)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*

##### **16 Del. Admin. Code § 3225-3.0** Glossary of Terms {#sec-3225-3.0 omnilex-key=us-de-regs-official--title-16--3225-3.0}

“Activities of Daily Living” (“ADLs”) - Normal daily activities including but not limited to ambulating, transferring, range of motion, grooming, bathing, dressing, eating, and toileting.

“Administration of Medication” - The process whereby a single dose of a prescribed drug is given to a resident by an authorized licensed person, as described in 24 Del.C. §1902.

“Assisted Living” - A special combination of housing, supportive services, supervision, personalized assistance and health care designed to respond to the individual needs of those who need help with activities of daily living and/or instrumental activities of daily living.

“Assisted Living Facility” – A licensed entity that provides the services described in Assisted Living.

“Assistive Technology” - Any item, piece of equipment or product system whether acquired commercially off the shelf, modified, or customized that is used to increase or improve functional capabilities of adults with disabilities.

“Assistance with Self-Administration of Medication” (“AWSAM”) - Assistance with medication provided by facility personnel who are not nurses or nurse practitioners but who have successfully completed a Board of Nursing-approved medication training program in accordance with the Delaware Nurse Practice Act, 24 Del.C. Ch. 19, and applicable rules and regulations. Assistance with medication includes holding the container, opening the container, and assisting the resident in taking the medication, other than by injection, following the directions of the original container, and documenting in the medication log that each medication has been taken by the residents.

“Communicable Disease” - An illness caused by a microorganism or its toxin characterized by spread from host to victim by air, contact, blood, or bodily fluids.

“Contract” – A legally binding written agreement between the facility and the resident which enumerates all charges for services, materials, and equipment, as well as non-financial obligations of both parties, as specified in these regulations.

“Cuing” - The act of guiding residents, verbally or by gestures, to facilitate memory and/or organize verbal and/or behavioral responses.

“Department” - Department of Health and Social Services.

“Division” - Division of Health Care Quality.

“Durable Medical Equipment” - Equipment capable of withstanding repeated use, primarily and customarily used to serve a medical purpose, generally not useful to a person in the absence of an illness or injury, and needed to maintain the resident in the facility, e.g., wheelchairs, hospital beds, oxygen tanks.

“Homelike” - Having the qualities of a home, including privacy, comfortable surroundings supported by the use of residential building materials and furnishings, and the opportunity to modify one’s living area to suit one’s individual preferences, in accordance with the facility’s policies. A homelike environment provides residents with an opportunity for self-expression and encourages interaction with community, family, and friends.

“Hospice” - An agency licensed by the State of Delaware that provides palliative and supportive medical and other health services to terminally ill residents and their families.

“Incident” - An occurrence or event, a record of which must be maintained in facility files, which includes all reportable incidents and the additional occurrences or events listed in Section 19.5 of these regulations. (Also see Reportable Incident, 19.6 and 19.7)

“Individual Living Unit” - A separate dwelling area within an assisted living facility which has living and sleeping space for one or more residents, as prescribed in these regulations.

“Instrumental Activities of Daily Living” (“IADLs”) - Home management skills, such as shopping for food and personal items, preparing meals, or handling money.

“Managed/Negotiated Risk Agreement” – A signed document between the resident and the facility, and any other involved party, which describes mutually agreeable action balancing resident choice and independence with the health and safety of the resident or others.

“Medication Log” – A written document in which licensed personnel and unlicensed personnel who have completed AWSAM training record administration/ assistance with the resident’s medications. The log shall list the resident’s name; date of birth; allergies; reason the medication is given; special instructions; and the dosage, route(s), and time(s), for all medications received/taken with staff administration or staff assistance. The log is signed/initialed by a staff member after each resident has received/taken the appropriate medication, or when the medication was not taken/given as prescribed.

“Medication Management by an Adult Family Member/Support Person” – Any help with prescription or non-prescription medication provided by an adult family member/support person, as identified in the resident’s contract and service agreement.

“Personal Care Supplies” - Those supplies, often disposable, used by a resident, such as incontinence products and hygiene supplies.

“Reportable Incident” - An occurrence or event which must be reported immediately to the Division and for which there is reasonable cause to believe that a resident has been abused, neglected, mistreated or subjected to financial exploitation as those terms are defined in 16 Del.C. §1131. Reportable incident also includes an occurrence or event listed in Sections 19.6 and 19.7 of these regulations. (Also see Incident, 19.5.)

“Representative” - A person acting on behalf of the resident pursuant to Delaware law.

“Resident” - An individual 18 years old or older who lives in an assisted living facility. Where appropriate in the context of these regulations, “resident” as used herein includes an authorized representative as defined in 3.0.

“Resident Assessment” - Evaluation of a resident’s physical, medical, and psychosocial status as documented in a Uniform Assessment Instrument (UAI), by a registered nurse.

“Resident Assistant” – Any unlicensed direct caregiver who, under the supervision of the assisted living director or director of health services, assists the resident with personal needs and monitors the activities of the resident while on the premises to ensure his/her health, safety, and well-being.

“Secretary” - Secretary of the Department of Health and Social Services.

“Service Agreement” - A written document developed with each resident which describes what services will be provided, who will provide the services, when the services will be provided, how the services will be provided, and, if applicable, the expected outcome.

“Shared Responsibility” - The concept that residents and assisted living facilities share responsibility for planning and decision-making affecting the resident.

“Significant Change” - A major deterioration or improvement in a resident’s health status or ability to perform ADLs; a major alteration in behavior or mood resulting in ongoing problematic behavior or the elimination of that behavior on a sustained basis. Significant change does not include ordinary, day-to-day fluctuations in health status, functioning, and behavior, or a short-term illness such as a cold, unless these fluctuations continue to recur, nor does it include deterioration that will normally resolve without further intervention.

“Significant Medication Error” – means one which causes the resident discomfort or jeopardizes his or her health or safety.

“Social Services” - Services provided to assist residents in maintaining or improving their ability to manage their everyday physical, mental and psychosocial needs.

“Third-Party Provider” - Any party, including a family member, other than the assisted living facility which furnishes services/supplies to a resident.

“Uniform Assessment Instrument” (“UAI”) - A document setting forth standardized criteria developed by the Division to assess each resident’s functional, cognitive, physical, medical, and psychosocial needs and status. The assisted living facility shall be required to use the UAI to evaluate each resident on both an initial and ongoing basis in accordance with these regulations.

“Vendor” – Any individual who is not employed by the facility but provides direct services to one or more facility residents.

**History**
- *8 DE Reg. 85 (07/01/04)*
- *15 DE Reg. 81 (07/01/11)*
- *15 DE Reg. 1156 (02/01/12)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*
- *8 DE Reg. 85 (07/01/04)*
- *13 DE Reg. 1328 (04/01/10)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 192 (08/01/11)*
- *15 DE Reg. 81 (07/01/11)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 81 (07/01/11)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 81 (07/01/11)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*
- *13 DE Reg. 1328 (04/01/10)*
- *13 DE Reg. 1328 (04/01/10)*
- *8 DE Reg. 85 (07/01/04)*
- *16 DE Reg. 865 (02/01/13)*
- *24 DE Reg. 579 (12/01/20)*
- *8 DE Reg. 85 (07/01/04)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 1156 (02/01/12)*
- *6 DE Reg. 525 (10/01/02)*
- *14 DE Reg. 1190 (05/01/11)*
- *15 DE Reg. 81 (07/01/11)*
- *15 DE Reg. 1156 (02/01/12)*
- *16 DE Reg. 865 (02/01/13)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*

##### **16 Del. Admin. Code § 3225-4.0** Licensing Requirements And Procedures {#sec-3225-4.0 omnilex-key=us-de-regs-official--title-16--3225-4.0}

4.1 No entity shall hold itself out as being an assisted living facility unless such entity has been duly licensed under these regulations and in accordance with state law. The Secretary or his/her designee shall issue a provisional or annual license for a specified number of beds.

4.2 Procedures for assisted living facility applications and for issuance, posting, and renewal of licenses shall be in accordance with 16 Del.C. Ch. 11, Subchapter I, Licensing by the State.

4.3 Inspections and monitoring shall be conducted in accordance with 16 Del.C. Ch. 11, Subchapter I., Licensing By The State.

4.4 Upon receipt of written notice of a violation of these regulations, the assisted living facility shall submit a written plan of action to correct deficiencies cited within 10 working days or such other time period as may be required by the Department. The plan of action shall address corrective actions to be taken and include all measures and completion dates to prevent their recurrence: 1) how the corrective action will be accomplished for those residents found to have been affected by the deficient practice; 2) how the facility will identify other residents having the potential to be affected by the same deficient practice; 3) what measures will be put into place or systemic changes made to ensure that the deficient practice will not recur; and 4) how the facility will monitor its corrective actions to ensure that the deficient practice is being corrected and will not recur, i.e., what program will be put into place to monitor the continued effectiveness of the systemic changes.

4.5 The Department may impose civil money penalties and/or other enforcement remedies in accordance with the procedures outlined in 16 Del.C. Ch. 11, Subchapter I., Licensing by the State.

4.6 The Department may suspend or revoke a license, or refuse to renew it, in accordance with 16 Del.C. Ch. 11, Subchapter I., Licensing by the State.

4.7 Separate licenses are required for agencies maintained in separate locations, even though operated under the same management. A separate license is not required for separate buildings maintained by the same management on the same grounds. Under conditions of assignment or transfer of ownership, a new license shall be required.

4.8 If a facility or part of a facility plans to close:

4.8.1 The assisted living facility shall notify representatives of the appropriate state agencies of the plan of closure at least 90 days before the planned closure.

4.8.2 The facility staff must notify each resident advising him/her of the action in progress at least 90 days before the planned closure.

4.8.3 The resident must be given the opportunity to designate a preference for a specific facility or for other arrangements.

4.8.4 The assisted living facility must arrange for the relocation to other facilities in the area in accordance with the residents’ preference, if possible.

4.8.5 Any applicant for admission to the assisted living facility shall be advised of the planned closure date.

4.8.6 All residents’ records and any medications must accompany the residents to their new residences.

4.9 The Department may adopt, amend or repeal regulations governing the operation of the agencies defined in 16 Del.C. Ch. 11, Subchapter I., Licensing By The State.

**History**
- *8 DE Reg. 85 (07/01/04)*
- *15 DE Reg. 81 (07/01/11)*
- *15 DE Reg. 1156 (02/01/12)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*
- *8 DE Reg. 85 (07/01/04)*
- *13 DE Reg. 1328 (04/01/10)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 192 (08/01/11)*
- *15 DE Reg. 81 (07/01/11)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 81 (07/01/11)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 81 (07/01/11)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*
- *13 DE Reg. 1328 (04/01/10)*
- *13 DE Reg. 1328 (04/01/10)*
- *8 DE Reg. 85 (07/01/04)*
- *16 DE Reg. 865 (02/01/13)*
- *24 DE Reg. 579 (12/01/20)*
- *8 DE Reg. 85 (07/01/04)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 1156 (02/01/12)*
- *6 DE Reg. 525 (10/01/02)*
- *14 DE Reg. 1190 (05/01/11)*
- *15 DE Reg. 81 (07/01/11)*
- *15 DE Reg. 1156 (02/01/12)*
- *16 DE Reg. 865 (02/01/13)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*

##### **16 Del. Admin. Code § 3225-5.0** General Requirements {#sec-3225-5.0 omnilex-key=us-de-regs-official--title-16--3225-5.0}

5.1 All written information provided by the assisted living facility including the written application process shall be accurate, precise, easily understood and readable by a resident, and in compliance with all applicable laws. If an applicant is rejected the facility shall provide clear reasons for the rejection in writing upon request.

5.2 All records maintained by the assisted living facility shall at all times be open to inspection and copying by the authorized representatives of the Department, as well as other agencies as required by state and federal laws and regulations. Such records shall be made available in accordance with 16 Del.C. Ch. 11, Subchapter I., Licensing by the State.

5.3 The assisted living facility shall adopt internal written policies and procedures pursuant to these regulations. No policies shall be adopted by the assisted living facility which are in conflict with these regulations.

5.4 The assisted living facility shall establish and adhere to written policies and procedures regarding the rights and responsibilities of residents, and these policies and procedures shall be made available to authorized representatives of the Department, facility staff, and residents.

5.5 The assisted living facility shall develop and adhere to policies and procedures to prevent residents with diagnosed memory impairment from wandering away from safe areas. However, residents may be permitted to wander safely within the perimeter of a secured unit.

5.6 The assisted living facility shall arrange for emergency transportation and care.

5.7 Inspection summaries and compliance history information shall be posted by the facility in accordance with 16 Del.C. Ch. 11, Subchapter I., Licensing by the State.

5.8 An assisted living facility shall recognize the authority of a representative acting on the resident’s behalf pursuant to Delaware law, as long as such representative does not exceed his/her authority. The facility shall request and keep on file any documents such as an advance directive, living will, do not resuscitate, and power(s) of attorney.

5.9 An assisted living facility shall not admit, provide services to, or permit the provision of services to individuals who, as established by the resident assessment:

5.9.1 Require care by a nurse that is more than intermittent or for more than a limited period of time;

5.9.2 Require skilled monitoring, testing, and aggressive adjustment of medications and treatments where there is the presence of, or reasonable potential of, an acute episode unless there is an RN to provide appropriate care;

5.9.3 Require monitoring of a chronic medical condition that is not essentially stabilized through available medications and treatments;

5.9.4 Are bedridden for more than 14 days;

5.9.5 Have developed stage three or four skin ulcers;

5.9.6 Require a ventilator;

5.9.7 Require treatment for a disease or condition which requires more than contact isolation;

5.9.8 Have an unstable tracheostomy or have a stable tracheostomy of less than 6 months’ duration;

5.9.9 Have an unstable peg tube;

5.9.10 Require an IV or central line with an exception for a completely covered subcutaneously implanted venous port provided the assisted living facility meets the following standards:

5.9.10.1 Facility records shall include the type, purpose and site of the port, the insertion date, and the last date medication was administered or the port flushed.

5.9.10.2 The facility shall document the presence of the port on the Uniform Assessment Instrument, the service plan, interagency referrals and any facility reports,

5.9.10.3 The facility shall not permit the provision of care to the port or surrounding area, the administration of medication or the flushing of the port or the surgical removal of the port within the facility by facility staff, physicians or third party providers;

5.9.11 Wander such that the assisted living facility would be unable to provide adequate supervision and/or security arrangements;

5.9.12 Exhibit behaviors that present a threat to the health or safety of themselves or others, such that the assisted living facility would be unable to eliminate the threat either through immediate discharge or use of immediate appropriate treatment modalities with measurable documented progress within 45 days; and

5.9.13 Are socially inappropriate as determined by the assisted living facility such that the facility would be unable to manage the behavior after documented, reasonable efforts such as clinical assessments and counseling for a period of no more than 60 days.

5.10 The provisions of section 5.9 above do not apply to residents under the care of a Hospice program licensed by the Department as long as the Hospice program provides written assurance that, in conjunction with care provided by the assisted living facility, all of the resident’s needs will be met without placing other residents at risk.

5.11 The Assisted Living facility shall cooperate fully with the state protection and advocacy agency, as defined in 16 Del.C. §1102(7), in fulfilling functions authorized by Title 16, Chapter 11.

5.12 An assisted living facility that provides direct healthcare services to persons diagnosed as having Alzheimer’s disease or other forms of dementia shall provide dementia specific training each year to those healthcare providers who must participate in continuing education programs. The mandatory training must include: communicating with persons diagnosed as having Alzheimer’s disease or other forms of dementia; the psychological, social, and physical needs of those persons; and safety measures which need to be taken with those persons. This paragraph shall not apply to persons certified to practice medicine under the Medical Practice Act, Chapter 17 of Title 24 of the Delaware Code.

**History**
- *8 DE Reg. 85 (07/01/04)*
- *15 DE Reg. 81 (07/01/11)*
- *15 DE Reg. 1156 (02/01/12)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*
- *8 DE Reg. 85 (07/01/04)*
- *13 DE Reg. 1328 (04/01/10)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 192 (08/01/11)*
- *15 DE Reg. 81 (07/01/11)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 81 (07/01/11)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 81 (07/01/11)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*
- *13 DE Reg. 1328 (04/01/10)*
- *13 DE Reg. 1328 (04/01/10)*
- *8 DE Reg. 85 (07/01/04)*
- *16 DE Reg. 865 (02/01/13)*
- *24 DE Reg. 579 (12/01/20)*
- *8 DE Reg. 85 (07/01/04)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 1156 (02/01/12)*
- *6 DE Reg. 525 (10/01/02)*
- *14 DE Reg. 1190 (05/01/11)*
- *15 DE Reg. 81 (07/01/11)*
- *15 DE Reg. 1156 (02/01/12)*
- *16 DE Reg. 865 (02/01/13)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*

##### **16 Del. Admin. Code § 3225-6.0** Resident Waivers {#sec-3225-6.0 omnilex-key=us-de-regs-official--title-16--3225-6.0}

6.1 An assisted living facility may request a resident-specific waiver so that it may serve a current resident who temporarily requires care otherwise excluded in section 5.9. A waiver request shall contain documentation by a physician stating that the resident’s condition is expected to improve within 90 days.

6.2 The facility shall provide interim needed services by appropriate health care professionals while any waiver request is pending.

6.3 The assisted living facility shall submit in writing a request for a waiver, which shall include the following information:

6.3.1 An explanation of why the assisted living facility is seeking the waiver, to include physician documentation and a service agreement which details how staff will provide care;

6.3.2 An explanation of why denial of the waiver will impose a substantial hardship for the resident;

6.3.3 An explanation of why the waiver will not adversely affect the resident for whom the waiver is sought or other residents; and

6.3.4 The duration of the waiver, not to exceed 90 days for each incident or condition.

6.4 In evaluating a waiver request submitted under this regulation, the Department shall review the statements in the application and may:

6.4.1 Inspect the assisted living facility;

6.4.2 Confer with the Assisted Living Director or his/her designee;

6.4.3 Discuss the request with the resident to determine whether he/she believes a waiver is in his/her best interest; and/or

6.4.4 Review other waivers currently in place at the assisted living facility.

6.5 The Department shall issue a written decision on a waiver request submitted pursuant to these regulations within 5 business days of receipt of the request. If the Department grants the waiver, the written decision shall include the waiver’s duration. If the Department denies the waiver, the written decision shall explain the reason(s) for the denial. The assisted living facility may submit a revised waiver request no later than five days after the receipt of the denial. While the second waiver request is pending, the facility shall provide needed services by health care professionals as outlined in the second waiver request.

6.6 If an assisted living facility violates any condition of a waiver, or if it appears to the Department that the health or safety of the resident will be adversely affected by the continuation of a waiver, the Department may revoke it. The revocation may be appealed; however, transfer or discharge procedures in accordance with 16 Del.C. §1121(18), shall be commenced immediately.

**History**
- *8 DE Reg. 85 (07/01/04)*
- *15 DE Reg. 81 (07/01/11)*
- *15 DE Reg. 1156 (02/01/12)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*
- *8 DE Reg. 85 (07/01/04)*
- *13 DE Reg. 1328 (04/01/10)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 192 (08/01/11)*
- *15 DE Reg. 81 (07/01/11)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 81 (07/01/11)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 81 (07/01/11)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*
- *13 DE Reg. 1328 (04/01/10)*
- *13 DE Reg. 1328 (04/01/10)*
- *8 DE Reg. 85 (07/01/04)*
- *16 DE Reg. 865 (02/01/13)*
- *24 DE Reg. 579 (12/01/20)*
- *8 DE Reg. 85 (07/01/04)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 1156 (02/01/12)*
- *6 DE Reg. 525 (10/01/02)*
- *14 DE Reg. 1190 (05/01/11)*
- *15 DE Reg. 81 (07/01/11)*
- *15 DE Reg. 1156 (02/01/12)*
- *16 DE Reg. 865 (02/01/13)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*

##### **16 Del. Admin. Code § 3225-7.0** Specialized Care for Memory Impairment {#sec-3225-7.0 omnilex-key=us-de-regs-official--title-16--3225-7.0}

7.1 Any assisted living facility which offers to provide specialized care for residents with memory impairment shall be required to disclose its policies and procedures which describe the form of care or treatment provided, in addition to that care and treatment required by the rules and regulations herein.

7.2 Said disclosure shall be made to the Department and to any person seeking specialized care for memory impairment in an assisted living facility.

7.3 The information disclosed shall explain the additional care that is provided in each of the following areas:

7.3.1 Philosophy: a written statement of the agency’s overall philosophy and mission which reflects the needs of residents affected by memory impairment;

7.3.2 Resident Population: a description of the resident population to be served; the service agreement and its implementation;

7.3.3 Pre-Admission, Admission & Discharge: the process and criteria for placement, transfer or discharge from this specialized care;

7.3.4 Assessment, Care Planning & Implementation: the process used for assessment and establishing and updating the service agreement and its implementation,

7.3.5 Staffing Plan & Training Policies: staffing plan, orientation, and regular in-service education for specialized care;

7.3.6 Physical Environment: the physical environment and design features, including security systems, appropriate to support the functioning of adults with memory impairment;

7.3.7 Resident Activities: the frequency and types of resident activities;

7.3.8 Family Role in Care: the family involvement and family support programs;

7.3.9 Psychosocial Services: the process for addressing the mental health, behavior management, and social functioning needs of the resident;

7.3.10 Nutrition/Hydration: the frequency and types of nutrition and hydration services provided; and

7.3.11 Program Costs: the cost of care and any additional fees.

7.4 Any significant changes in the information provided by the assisted living facility shall be reported to the Department at the time the changes are made.

**History**
- *8 DE Reg. 85 (07/01/04)*
- *15 DE Reg. 81 (07/01/11)*
- *15 DE Reg. 1156 (02/01/12)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*
- *8 DE Reg. 85 (07/01/04)*
- *13 DE Reg. 1328 (04/01/10)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 192 (08/01/11)*
- *15 DE Reg. 81 (07/01/11)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 81 (07/01/11)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 81 (07/01/11)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*
- *13 DE Reg. 1328 (04/01/10)*
- *13 DE Reg. 1328 (04/01/10)*
- *8 DE Reg. 85 (07/01/04)*
- *16 DE Reg. 865 (02/01/13)*
- *24 DE Reg. 579 (12/01/20)*
- *8 DE Reg. 85 (07/01/04)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 1156 (02/01/12)*
- *6 DE Reg. 525 (10/01/02)*
- *14 DE Reg. 1190 (05/01/11)*
- *15 DE Reg. 81 (07/01/11)*
- *15 DE Reg. 1156 (02/01/12)*
- *16 DE Reg. 865 (02/01/13)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*

##### **16 Del. Admin. Code § 3225-8.0** Medication Management {#sec-3225-8.0 omnilex-key=us-de-regs-official--title-16--3225-8.0}

8.1 An assisted living facility shall establish and adhere to written medication policies and procedures which shall address:

8.1.1 Obtaining and refilling medication;

8.1.2 Storing and controlling medication;

8.1.3 Disposing of medication; and

8.1.4 Administration of medication, self-administration of medication, assistance with self-administration of medication, and medication management by an adult family member/support person.

8.1.5 Provision for a quarterly pharmacy review conducted by a pharmacist which shall include:

8.1.5.1 Assisting the facility with the development and implementation of medication-related policies and procedures;

8.1.5.2 Physical inspection of the medication storage areas;

8.1.5.3 Review of each resident’s medication regimen with written reports noting any identified irregularities or areas of concern.

8.2 Each assisted living facility shall have a drug reference guide, with a copyright date no older than 2 years, available and accessible for use by employees.

8.3 Medication stored by the assisted living facility shall be stored and controlled as follows:

8.3.1 Medication shall be stored in a locked container, cabinet, or area that is only accessible to authorized personnel;

8.3.2 Medication that is not in locked storage shall not be left unattended and shall not be accessible to unauthorized personnel;

8.3.3 Medication shall be stored in the original labeled container;

8.3.4 A bathroom or laundry room shall not be used for medication storage; and

8.3.5 All expired or discontinued medication, including those of deceased residents, shall be disposed of according to the assisted living facility’s medication policies and procedures.

8.4 Residents who self-administer medication shall be provided with a lockable container or cabinet. This requirement does not apply to medications which are kept in the immediate control of the individual resident, such as in a pocket or in a purse. Facility policies must require that medications be secured in a locked container or in a locked room.

8.5 A separate medication log must be maintained for each resident documenting administration of medication by staff and staff assistance with self-administration.

8.6 Within 30 days after a resident’s admission and concurrent with all UAI-based assessments, the assisted living facility shall arrange for an on-site review by an RN of the resident’s medication regime if he or she self-administers medication. The purpose of the on-site review is to assess the resident’s cognitive and physical ability to self-administer medication or the need for assistance with or staff administration of medication.

8.7 The assisted living facility shall ensure that the review required by section 8.6 is documented in the resident’s records, including any recommendations given by the reviewer.

8.8 Concurrently with all UAI-based assessments, the assisted living facility shall arrange for an on-site medication review by a registered nurse, for residents who need assistance with self-administration or staff administration of medication, to ensure that:

8.8.1 Medications are properly labeled, stored and maintained;

8.8.2 Each resident receives the medications that have been specifically prescribed in the manner that has been ordered;

8.8.3 The desired effect of each medication is achieved, and if not, that the appropriate authorized prescriber is so informed;

8.8.4 Any undesired side effects, adverse drug reactions, and medication errors are identified and reported to the appropriate authorized prescriber; and

8.8.5 Any unresolved discrepancy of controlled substances shall be reported to the Delaware Office of Narcotics and Dangerous Drugs.

8.9 Records shall be kept on file at the facility for those who have completed the AWSAM course which is required by 24 Del.C. Ch. 19 for those who assist the residents with self-administration of medication.

8.10 Each assisted living facility shall complete an annual AWSAM report on the form provided by the Board of Nursing. The report must be submitted pursuant to the Delaware Nurse Practice Act, 24 Del.C. Ch. 19.

**History**
- *8 DE Reg. 85 (07/01/04)*
- *15 DE Reg. 81 (07/01/11)*
- *15 DE Reg. 1156 (02/01/12)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*
- *8 DE Reg. 85 (07/01/04)*
- *13 DE Reg. 1328 (04/01/10)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 192 (08/01/11)*
- *15 DE Reg. 81 (07/01/11)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 81 (07/01/11)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 81 (07/01/11)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*
- *13 DE Reg. 1328 (04/01/10)*
- *13 DE Reg. 1328 (04/01/10)*
- *8 DE Reg. 85 (07/01/04)*
- *16 DE Reg. 865 (02/01/13)*
- *24 DE Reg. 579 (12/01/20)*
- *8 DE Reg. 85 (07/01/04)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 1156 (02/01/12)*
- *6 DE Reg. 525 (10/01/02)*
- *14 DE Reg. 1190 (05/01/11)*
- *15 DE Reg. 81 (07/01/11)*
- *15 DE Reg. 1156 (02/01/12)*
- *16 DE Reg. 865 (02/01/13)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*

##### **16 Del. Admin. Code § 3225-9.0** Infection Control {#sec-3225-9.0 omnilex-key=us-de-regs-official--title-16--3225-9.0}

9.1 The assisted living facility shall establish written procedures to be followed in the event that a resident with a communicable disease is admitted or an episode of communicable disease occurs. It is the responsibility of the assisted living facility to see that:

9.1.1 The necessary precautions stated in the written procedures are followed; and

9.1.2 All rules of the Delaware Division of Public Health are followed so there is minimal danger of transmission to staff and residents.

9.2 Any resident found to have active tuberculosis in an infectious stage may not continue to reside in an assisted living facility.

9.3 A resident, when suspected or diagnosed as having a communicable disease, shall be placed on the appropriate isolation or precaution as recommended for that disease by the Centers for Disease Control. Those with a communicable disease which has been determined by the Director of the Division of Public Health to be a health hazard to visitors, staff, and other residents shall be placed on isolation care until they can be moved to an appropriate room or transferred.

9.4 The admission of a resident with or the occurrence of a disease or condition on the Division of Public Health List of Notifiable Diseases/Conditions within a nursing facility shall be reported to the resident's physician and the facility's medical director. The facility shall also report such an admission or occurrence to the Division of Public Health's Health Information and Epidemiology office.

9.4.1 The assisted living facility shall have policies and procedures for infection control as it pertains to staff, residents, and visitors.

9.4.2 All assisted living facility staff shall be required to use Standard Precautions.

9.5 Requirements for tuberculosis and immunizations:

9.5.1 The facility shall have on file the results of tuberculin testing performed on all newly placed residents.

9.5.2 Minimum requirements for pre-employment require all employees to have a base line two step tuberculin skin test (TST) or single Interferon Gamma Release Assay (IGRA or TB blood test) such as QuantiFeron. Any required subsequent testing according to risk category shall be in accordance with the recommendations of the Centers for Disease Control and Prevention of the U.S. Department of Health and Human Services. Should the category of risk change, which is determined by the Division of Public Health, the facility shall comply with the recommendations of the Center for Disease Control for the appropriate risk category.

9.5.2.1 No person, including volunteers, found to have active tuberculosis in an infectious stage shall be permitted to give care or service to residents.

9.5.2.2 Any person having a positive skin test but a negative X-ray shall receive an annual evaluation for signs and symptoms of active TB if they cannot provide documentation of completion of treatment for LTBI (latent TB infection).

9.5.2.3 Persons with a prior BCG vaccination are required to be tested as set forth in 9.5.2.

9.5.2.4 A report of all test results shall be kept on file at the facility of employment.

9.6 The assisted living facility shall have on file evidence of annual vaccination against influenza for all residents, as recommended by the Immunization Practice Advisory Committee of the Centers for Disease Control, unless medically contraindicated. All residents who refuse to be vaccinated against influenza must be fully informed by the facility of the health risks involved. The reason for the refusal shall be documented in the resident’s medical record.

9.7 The assisted living facility shall have on file evidence of vaccination against pneumococcal pneumonia for all residents older than 65 years, or those who received the pneumococcal vaccine before they became 65 years and 5 years have elapsed, and as recommended by the Immunization Practice Advisory Committee of the Centers for Disease Control, unless medically contraindicated. All residents who refuse to be vaccinated against pneumococcal pneumonia must be fully informed by the facility of the health risks involved. The reason for the refusal shall be documented in the resident’s medical record.

9.8 Specific Requirements for COVID-19:

9.8.1 Residents

9.8.1.1 All residents should be tested upon identification of another resident with symptoms consistent with COVID-19, or if facility staff have tested positive for COVID-19.

9.8.1.2 All other resident testing should be consistent with Division of Public Health guidance for the duration of the public health emergency.

9.8.1.3 All testing and test results must be documented in the resident medical record.

9.8.1.4 Facilities must report all resident testing and test results, to the Delaware Division of Public Health.

9.8.2 Staff, vendors and volunteers

9.8.2.1 Prior to their start date, all new staff, vendors and volunteers must be tested in accordance with the Delaware Division of Public Health guidance.

9.8.2.2 All staff, vendors and volunteers who test negative must be retested consistent with Division of Public Health guidance for the duration of the public health emergency.

9.8.2.3 Facilities must report all staff, vendor and volunteer testing and test results, to the Delaware Division of Public Health.

9.8.2.4 Facilities must follow recommendations of the Centers for Disease Control and Prevention of the U.S. Department of Health and Human Services and the Division of Public Health regarding the provision of care or services to residents by staff, vendor or volunteer found to be positive for COVID-19 in an infectious stage.

9.8.2.5 Facilities shall amend their policies and procedures to include:

9.8.2.5.1 Work exclusion and return to work protocols for staff tested positive for COVID-19.

9.8.2.5.2 Staff refusals to participate in COVID-19 testing.

9.8.2.5.3 Staff refusals to authorize release of their testing results to the facility.

9.8.2.5.4 Procedures to obtain staff authorizations for release of laboratory test results to the facility so as to inform infection control and prevention strategies.

9.8.2.5.5 Plans to address staffing shortages and facility demands should a COVID-19 outbreak occur.

9.9 Infection Prevention and Control Program

9.9.1 The assisted living facility shall establish an infection prevention and control program with shall be based upon Centers for Disease Control and Prevention and other nationally recognized infection prevention and control guidelines.

9.9.1.1 The infection prevention and control program must cover all services and all areas of the assisted living facilities, including provision of the appropriate personal protective equipment for all residents, staff and visitors.

9.9.2 The individual designated to lead the assisted living facility’s infection prevention and control program must develop and implement a comprehensive plan that includes actions to prevent, identify, and manage infections and communicable diseases. The plan must include mechanisms that result in immediate action to take preventive or corrective measures that improve the assisted living facility’s infection control outcomes.

9.9.3 All assisted living facility staff shall receive orientation at the time of employment and annual in-service education regarding the infection prevention and control program.

**History**
- *8 DE Reg. 85 (07/01/04)*
- *15 DE Reg. 81 (07/01/11)*
- *15 DE Reg. 1156 (02/01/12)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*
- *8 DE Reg. 85 (07/01/04)*
- *13 DE Reg. 1328 (04/01/10)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 192 (08/01/11)*
- *15 DE Reg. 81 (07/01/11)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 81 (07/01/11)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 81 (07/01/11)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*
- *13 DE Reg. 1328 (04/01/10)*
- *13 DE Reg. 1328 (04/01/10)*
- *8 DE Reg. 85 (07/01/04)*
- *16 DE Reg. 865 (02/01/13)*
- *24 DE Reg. 579 (12/01/20)*
- *8 DE Reg. 85 (07/01/04)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 1156 (02/01/12)*
- *6 DE Reg. 525 (10/01/02)*
- *14 DE Reg. 1190 (05/01/11)*
- *15 DE Reg. 81 (07/01/11)*
- *15 DE Reg. 1156 (02/01/12)*
- *16 DE Reg. 865 (02/01/13)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*

##### **16 Del. Admin. Code § 3225-10.0** Contracts {#sec-3225-10.0 omnilex-key=us-de-regs-official--title-16--3225-10.0}

10.1 The assisted living facility shall supply a written contract that is precise, easily understood and readable by a resident, and in compliance with all applicable laws.

10.2 The assisted living facility shall recommend review of the contract by an attorney or other representative chosen by the resident.

10.3 Prior to executing the contract, each assisted living facility shall provide to the prospective resident a complete statement enumerating all charges for services, materials and equipment which shall, or may be, furnished to the resident during the period of occupancy.

10.4 The resident shall sign a contract within 3 business days after admission that:

10.4.1 Is a clear and complete reflection of commitments agreed to by the parties and the actual practices that will occur in the assisted living program;

10.4.2 Is accurate, precise, legible, and written in plain language; and

10.4.3 Conforms to all relevant state and local laws and regulations.

10.5 The assisted living facility shall retain the contract on-site and make it available for review by the Department or its designee. The facility shall also provide a copy to the resident.

10.6 The contract or service agreement shall include, at a minimum, the following non-financial provisions:

10.6.1 A listing of basic and optional services provided by the assisted living facility including the availability of licensed nursing staff;

10.6.2 A listing of optional services that may be provided by third parties;

10.6.3 A statement of the resident’s rights, as set forth in 16 Del.C. Ch. 11, Subchapter II and an explanation of the assisted living facility’s grievance procedures;

10.6.4 Occupancy provisions, including:

10.6.4.1 Policies regarding bed and room assignment, including the specific room and bed assigned to the resident at the time of admission;

10.6.4.2 Policies regarding residents modifying their living area;

10.6.4.3 Procedures to be followed when the assisted living facility temporarily or permanently changes the resident’s accommodation by:

10.6.4.3.1 Relocating the resident within the facility;

10.6.4.3.2 Making a change in roommate assignment; and

10.6.4.3.3 Increasing or decreasing the number of individuals occupying a room.

10.6.4.4 Procedures to be followed in transferring the resident to another facility;

10.6.4.5 Security procedures which the licensee shall implement to protect the resident and the resident’s property;

10.6.4.6 The staff’s right to enter a resident’s room;

10.6.4.7 The resident’s rights and obligations concerning use of the facility, including common areas;

10.6.4.8 The assisted living facility’s policy in case of unavoidable or optional absences such as hospitalizations, recuperative stays in other settings, or vacation, and payment terms;

10.6.4.9 Provisions for interim service in the event of an emergency; and

10.6.4.10 An acknowledgment that the resident has reviewed all assisted living facility rules, requirements, restrictions, or special conditions that the facility will impose on the resident.

10.6.5 Discharge/temporary absence policies and procedures, including:

10.6.5.1 Those actions, circumstances, or conditions that temporarily disqualify individuals from continued residence in the assisted living facility or may result in the resident’s discharge from the facility;

10.6.5.2 The procedures which the assisted living facility shall follow if it intends to discharge a resident and thereby terminate the contract, including a provision under which the assisted living facility shall give at least 30 days notice to the resident before the effective date of the discharge and termination of the contract, except in the case of a health emergency or substantial risk to the health and safety of the other residents or facility staff;

10.6.5.3 The procedures which the resident shall follow if the resident wishes to terminate the contract, including a provision that the resident, or appropriate representative, shall give at least 30 days notice to the assisted living facility before the effective date of the termination, except in the case of a health emergency;

10.6.5.4 The procedures which the assisted living facility shall follow in helping the resident find an appropriate placement;

10.6.5.5 In a living unit in which more than one resident is the contracting party, the terms under which the contract may be modified in the event of one of the resident’s discharge or death, including the provisions for termination of the contract and appropriate refunds.

10.6.6 Obligations of the facility and the resident as to:

10.6.6.1 Arranging for or overseeing medical care; and

10.6.6.2 Monitoring of the status of the resident.

10.6.7 The assisted living facility’s formal internal grievance process which shall protect residents from reprisal by the facility or its employees.

10.6.8 An inventory of the resident’s personal belongings, if the resident so desires.

10.7 The contract shall include, at a minimum, the following financial provisions:

10.7.1 Party responsible for:

10.7.1.1 Handling the finances of the resident;

10.7.1.2 Purchasing or renting essential or desired equipment and supplies;

10.7.1.3 Arranging and contracting for services not covered by the contract;

10.7.1.4 Ascertaining the cost of and purchasing durable medical equipment; and

10.7.1.5 Disposing of the resident’s property upon discharge or death of the resident.

10.7.2 Rate structure and payment provisions including:

10.7.2.1 All rates to be charged to the resident, including, but not limited to:

10.7.2.1.1 Service packages;

10.7.2.1.2 Fee for service rates; and

10.7.2.1.3 Other ancillary charges.

10.7.2.2 Notification of the rate structure and the criteria to be used for imposing additional charges for the provision of additional services, if the resident’s service and care needs change;

10.7.2.3 Identification of the persons responsible for payment of all fees and charges and a clear indication of whether the person’s responsibility is or is not limited to the extent of the resident’s funds;

10.7.2.4 A provision which provides at least 60 days notice of any rate increase, except if necessitated by a change in the resident’s medical condition;

10.7.2.5 Billing, payment, and credit policies, including the procedures that the assisted living facility will follow in the event the resident can no longer pay for services provided or for services or care needed by the resident; and

10.7.2.6 A description of any prepaid fees or charges and the terms governing refund of those fees or charges in the event of a resident’s discharge from the assisted living facility or termination of the contract.

10.8 The contract shall be amended by the parties to reflect any applicable increase or decrease in charges. Modification may be done by an addendum to the contract.

10.9 All notices to be provided pursuant to an assisted living contract shall be in writing and mailed or hand-delivered to the resident.

10.10 No contract shall be signed before a full assessment of the resident has been completed and a service agreement has been executed. If a deposit is required prior to move-in, the deposit shall be fully refundable if the parties cannot agree on the services and fees upon completion of the assessment.

**History**
- *8 DE Reg. 85 (07/01/04)*
- *15 DE Reg. 81 (07/01/11)*
- *15 DE Reg. 1156 (02/01/12)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*
- *8 DE Reg. 85 (07/01/04)*
- *13 DE Reg. 1328 (04/01/10)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 192 (08/01/11)*
- *15 DE Reg. 81 (07/01/11)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 81 (07/01/11)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 81 (07/01/11)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*
- *13 DE Reg. 1328 (04/01/10)*
- *13 DE Reg. 1328 (04/01/10)*
- *8 DE Reg. 85 (07/01/04)*
- *16 DE Reg. 865 (02/01/13)*
- *24 DE Reg. 579 (12/01/20)*
- *8 DE Reg. 85 (07/01/04)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 1156 (02/01/12)*
- *6 DE Reg. 525 (10/01/02)*
- *14 DE Reg. 1190 (05/01/11)*
- *15 DE Reg. 81 (07/01/11)*
- *15 DE Reg. 1156 (02/01/12)*
- *16 DE Reg. 865 (02/01/13)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*

##### **16 Del. Admin. Code § 3225-11.0** Resident Assessment {#sec-3225-11.0 omnilex-key=us-de-regs-official--title-16--3225-11.0}

11.1 Each assisted living facility shall use a Uniform Assessment Instrument (UAI) developed by the Division. The UAI shall be used in conducting all resident assessments.

11.2 A resident seeking entrance shall have an initial UAI-based resident assessment completed by a registered nurse (RN) acting on behalf of the assisted living facility no more than 30 days prior to admission. In all cases, the assessment shall be completed prior to admission. Such assessment shall be reviewed by an RN within 30 days after admission and, if appropriate, revised. If the resident requires specialized medical, therapeutic, nursing services, or assistive technology, that component of the assessment must be performed by personnel qualified in that specialty area.

11.3 Within 30 days prior to admission, a prospective resident shall have a medical evaluation completed by a physician.

11.4 The resident assessment shall be completed in conjunction with the resident.

11.5 The UAI, developed by the Department, shall be used to update the resident assessment. At a minimum, regular updates must occur 30 days after admission, annually and when there is a significant change in the resident’s condition.

11.6 If the needs of a resident exceed the care which the assisted living facility can provide and a waiver has not been requested, the facility shall assist the resident in making arrangements for an appropriate transfer within 30 days. While a transfer is pending, the assisted living facility shall coordinate the provision of services needed by the resident.

11.7 The assisted living facility shall provide an instrument to assess interests, strengths, talents, skills and preferences of each resident within 30 days of admission to be used in activity planning.

**History**
- *8 DE Reg. 85 (07/01/04)*
- *15 DE Reg. 81 (07/01/11)*
- *15 DE Reg. 1156 (02/01/12)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*
- *8 DE Reg. 85 (07/01/04)*
- *13 DE Reg. 1328 (04/01/10)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 192 (08/01/11)*
- *15 DE Reg. 81 (07/01/11)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 81 (07/01/11)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 81 (07/01/11)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*
- *13 DE Reg. 1328 (04/01/10)*
- *13 DE Reg. 1328 (04/01/10)*
- *8 DE Reg. 85 (07/01/04)*
- *16 DE Reg. 865 (02/01/13)*
- *24 DE Reg. 579 (12/01/20)*
- *8 DE Reg. 85 (07/01/04)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 1156 (02/01/12)*
- *6 DE Reg. 525 (10/01/02)*
- *14 DE Reg. 1190 (05/01/11)*
- *15 DE Reg. 81 (07/01/11)*
- *15 DE Reg. 1156 (02/01/12)*
- *16 DE Reg. 865 (02/01/13)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*

##### **16 Del. Admin. Code § 3225-12.0** Services {#sec-3225-12.0 omnilex-key=us-de-regs-official--title-16--3225-12.0}

12.1 The assisted living facility shall ensure that:

12.1.1 Three meals, snacks and prescribed food supplements are available during each 24-hour period, 7 days per week;

12.1.2 Meals and snacks are varied, palatable, and of sufficient quality and quantity to meet the daily nutritional needs of each resident with specific attention given to the special dietary needs of each resident;

12.1.3 Food service complies with the Delaware Food Code; and

12.1.4 A resident who chooses not to follow prescribed dietary recommendations shall be provided documented counseling on potential adverse outcomes.

12.2 As part of the licensure approval and renewal process, an assisted living applicant or licensee shall submit at least a 4-week menu cycle with documentation by a dietician or nutritionist that the menus are nutritionally adequate. Thereafter, menus are to be written at least one week in advance and maintained on file, as served, for two months.

12.3 The assisted living facility shall ensure that the resident’s service agreement is being properly implemented.

12.4 In accordance with the service agreement, the assisted living facility shall provide or ensure the provision of all necessary personal services, including all activities of daily living, and shall ensure that personal care supplies are available.

12.5 The assisted living facility shall ensure that laundry and housekeeping services are offered and that all areas of the facility are maintained in a clean and orderly condition.

12.6 In accordance with the service agreement, the assisted living facility shall be responsible for facilitating access to appropriate health care and social services for the resident.

12.7 The assisted living facility shall assess each resident and provide or arrange appropriate opportunities for social interaction and leisure activities which promote the physical and mental well-being of each resident, including facilitating access to spiritual activities consistent with the preferences and background of the resident.

**History**
- *8 DE Reg. 85 (07/01/04)*
- *15 DE Reg. 81 (07/01/11)*
- *15 DE Reg. 1156 (02/01/12)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*
- *8 DE Reg. 85 (07/01/04)*
- *13 DE Reg. 1328 (04/01/10)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 192 (08/01/11)*
- *15 DE Reg. 81 (07/01/11)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 81 (07/01/11)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 81 (07/01/11)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*
- *13 DE Reg. 1328 (04/01/10)*
- *13 DE Reg. 1328 (04/01/10)*
- *8 DE Reg. 85 (07/01/04)*
- *16 DE Reg. 865 (02/01/13)*
- *24 DE Reg. 579 (12/01/20)*
- *8 DE Reg. 85 (07/01/04)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 1156 (02/01/12)*
- *6 DE Reg. 525 (10/01/02)*
- *14 DE Reg. 1190 (05/01/11)*
- *15 DE Reg. 81 (07/01/11)*
- *15 DE Reg. 1156 (02/01/12)*
- *16 DE Reg. 865 (02/01/13)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*

##### **16 Del. Admin. Code § 3225-13.0** Service Agreements {#sec-3225-13.0 omnilex-key=us-de-regs-official--title-16--3225-13.0}

13.1 A service agreement based on the needs identified in the UAI shall be completed prior to or no later than the day of admission. The resident shall participate in the development of the agreement. The resident and the facility shall sign the agreement and each shall receive a copy of the signed agreement. All persons who sign the agreement must be able to comprehend and perform their obligations under the agreement.

13.2 The service agreement or contract shall address the physical, medical, and psychosocial services that the resident requires as follows:

13.2.1 Assistance with activities of daily living and instrumental activities of daily living;

13.2.2 Services provided by licensed nurses;

13.2.3 Food, nutrition, and hydration services;

13.2.4 Environmental services including housekeeping, laundry, safety, trash removal;

13.2.5 Psychosocial/emotional services including those related to memory impairment and other cognitive deficits;

13.2.6 Banking, record keeping, and personal spending services;

13.2.7 Transportation services;

13.2.8 Individual living unit furnishings;

13.2.9 Notification procedures when an incident occurs or there is a change in the health status of the resident;

13.2.10 Assistive technology and durable medical equipment;

13.2.11 Rehabilitation services;

13.2.12 Qualified interpreters for people who have a hearing impairment or do not speak English; and

13.2.13 Reasonable accommodations for persons with disabilities as defined by applicable state and federal law.

13.3 The resident’s personal attending physician(s) shall be identified in the service agreement by name, address, and telephone number.

13.4 The facility shall be responsible for appropriate documentation in the service agreement for services provided or arranged by the facility.

13.5 The service agreement shall be developed and followed for each resident consistent with that person’s unique physical and psychosocial needs with recognition of his/her capabilities and preferences.

13.6 The service agreement shall be reviewed when the needs of the resident have changed and, minimally, in conjunction with each UAI. Within 10 days of such assessment, the resident and the assisted living facility shall execute a revised service agreement, if indicated.

13.7 The service agreement shall be based on the concepts of shared responsibility and resident choice. To participate fully in shared responsibility, residents shall be provided with clear and understandable information about the possible consequences of their decision-making. If a resident’s preference or decision places the resident or others at risk or is likely to lead to adverse consequences, a managed/negotiated risk agreement section may be included in the service agreement.

13.8 The following are criteria for a managed/ negotiated risk agreement:

13.8.1 The risks are tolerable to all parties participating in the development of the managed/negotiated risk agreement;

13.8.2 Mutually agreeable action is negotiated to provide the greatest amount of resident autonomy with the least amount of risk; and

13.8.3 The resident living in the facility is capable of making choices and decisions and understanding consequences.

13.9 If a managed/negotiated risk agreement is made a part of the service agreement, it shall:

13.9.1 Clearly describe the problem, issue or service that is the subject of the managed/negotiated risk agreement;

13.9.2 Describe the choices available to the resident as well as the risks and benefits associated with each choice, the assisted living facility’s recommendations or desired outcome, and the resident’s desired preference;

13.9.3 Indicate the agreed-upon option;

13.9.4 Describe the agreed upon responsibilities of the assisted living facility, the resident, and any third parties;

13.9.5 Become a part of the service agreement, be signed separately by the resident, the assisted living facility, and any third party with obligations under the managed/ negotiated risk agreement that the third party is able to fully comprehend and perform; and

13.9.6 Include a time frame for review.

13.10 The assisted living facility shall have sufficient staff to meet its responsibilities under the managed/negotiated risk agreement.

13.11 The assisted living facility shall not use managed/negotiated risk agreements to provide care to residents with needs beyond the capability of the facility. A managed/negotiated risk agreement shall not be used to supersede any requirements of these regulations.

13.12 The assisted living facility shall make no attempt to use the managed/negotiated risk portion of the service agreement to abridge a resident’s rights or to avoid liability for harm caused to a resident by the negligence of the assisted living facility and any such abridgement or disclaimer shall be void.

**History**
- *8 DE Reg. 85 (07/01/04)*
- *15 DE Reg. 81 (07/01/11)*
- *15 DE Reg. 1156 (02/01/12)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*
- *8 DE Reg. 85 (07/01/04)*
- *13 DE Reg. 1328 (04/01/10)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 192 (08/01/11)*
- *15 DE Reg. 81 (07/01/11)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 81 (07/01/11)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 81 (07/01/11)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*
- *13 DE Reg. 1328 (04/01/10)*
- *13 DE Reg. 1328 (04/01/10)*
- *8 DE Reg. 85 (07/01/04)*
- *16 DE Reg. 865 (02/01/13)*
- *24 DE Reg. 579 (12/01/20)*
- *8 DE Reg. 85 (07/01/04)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 1156 (02/01/12)*
- *6 DE Reg. 525 (10/01/02)*
- *14 DE Reg. 1190 (05/01/11)*
- *15 DE Reg. 81 (07/01/11)*
- *15 DE Reg. 1156 (02/01/12)*
- *16 DE Reg. 865 (02/01/13)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*

##### **16 Del. Admin. Code § 3225-14.0** Resident Rights {#sec-3225-14.0 omnilex-key=us-de-regs-official--title-16--3225-14.0}

14.1 Assisted living facilities are required by 16 Del.C. Ch. 11, Subchapter II, to comply with the provisions of the Rights of Patients covered therein.

14.2 Each resident has the right of privacy in his/her room, including a door that locks, consistent with the safety needs of the resident.

**History**
- *8 DE Reg. 85 (07/01/04)*
- *15 DE Reg. 81 (07/01/11)*
- *15 DE Reg. 1156 (02/01/12)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*
- *8 DE Reg. 85 (07/01/04)*
- *13 DE Reg. 1328 (04/01/10)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 192 (08/01/11)*
- *15 DE Reg. 81 (07/01/11)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 81 (07/01/11)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 81 (07/01/11)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*
- *13 DE Reg. 1328 (04/01/10)*
- *13 DE Reg. 1328 (04/01/10)*
- *8 DE Reg. 85 (07/01/04)*
- *16 DE Reg. 865 (02/01/13)*
- *24 DE Reg. 579 (12/01/20)*
- *8 DE Reg. 85 (07/01/04)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 1156 (02/01/12)*
- *6 DE Reg. 525 (10/01/02)*
- *14 DE Reg. 1190 (05/01/11)*
- *15 DE Reg. 81 (07/01/11)*
- *15 DE Reg. 1156 (02/01/12)*
- *16 DE Reg. 865 (02/01/13)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*

##### **16 Del. Admin. Code § 3225-15.0** Quality Assurance {#sec-3225-15.0 omnilex-key=us-de-regs-official--title-16--3225-15.0}

The assisted living facility shall develop, implement, and adhere to a documented, ongoing quality assurance program that includes an internal monitoring process that tracks performance and measures resident satisfaction.

**History**
- *8 DE Reg. 85 (07/01/04)*
- *15 DE Reg. 81 (07/01/11)*
- *15 DE Reg. 1156 (02/01/12)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*
- *8 DE Reg. 85 (07/01/04)*
- *13 DE Reg. 1328 (04/01/10)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 192 (08/01/11)*
- *15 DE Reg. 81 (07/01/11)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 81 (07/01/11)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 81 (07/01/11)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*
- *13 DE Reg. 1328 (04/01/10)*
- *13 DE Reg. 1328 (04/01/10)*
- *8 DE Reg. 85 (07/01/04)*
- *16 DE Reg. 865 (02/01/13)*
- *24 DE Reg. 579 (12/01/20)*
- *8 DE Reg. 85 (07/01/04)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 1156 (02/01/12)*
- *6 DE Reg. 525 (10/01/02)*
- *14 DE Reg. 1190 (05/01/11)*
- *15 DE Reg. 81 (07/01/11)*
- *15 DE Reg. 1156 (02/01/12)*
- *16 DE Reg. 865 (02/01/13)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*

##### **16 Del. Admin. Code § 3225-16.0** Staffing {#sec-3225-16.0 omnilex-key=us-de-regs-official--title-16--3225-16.0}

16.1 As used herein “staff” includes permanent employees of the assisted living facility and independent contractors, including “temps.”

16.2 A staff of persons sufficient in number and adequately trained, certified or licensed to meet the requirements of the residents shall be employed and shall comply with applicable state laws and regulations.

16.3 All direct care staff shall be familiar with the service agreement for each resident for whom they provide care.

16.4 Every assisted living facility shall have a Director. Facilities licensed for 25 beds or more shall have a full-time Nursing Home Administrator. Facilities licensed for 5 through 24 beds shall have a part-time Nursing Home Administrator on-site and on-duty at least 20 hours a week. If the assisted living facility is part of a continuing care retirement community (CCRC) or part of a campus under the same ownership, the CCRC or campus may operate under one licensed Nursing Home Administrator.

16.5 The Nursing Home Administrator shall comply with the provisions of 24 Del.C. Ch. 52, and the Board’s Rules and Regulations.

16.6 The Director/Nursing Home Administrator shall have overall responsibility for managing the assisted living facility such that all requirements of state law and regulations are met.

16.7 The Director of a facility for 4 beds or fewer shall meet one of the following criteria:

16.7.1 A baccalaureate degree in a health or social services field or business administration; or

16.7.2 An associates degree in a health or social services field or business administration and at least 2 years of full-time equivalent work experience in these disciplines; or

16.7.3 An RN with a combined total of 4 years full-time equivalent education and related work experience; or

16.7.4 At least 4 years full-time equivalent work experience as an LPN, or 5 years full-time equivalent work experience in a health or social services field or business administration.

16.8 The Director of a Facility for 4 beds or fewer shall be on-site at least 8 hours a week.

16.9 Each facility for 4 beds or fewer shall have a full-time, on-site house manager who shall at a minimum:

16.9.1 Possess a high school diploma or its equivalent;

16.9.2 Be certified as a CNA with at least three years experience providing care in a health care setting;

16.9.3 Complete an orientation program in accordance with the CNA regulations; and

16.9.4 Receive, at a minimum, 12 hours of regular in-service education annually, which may include but not be limited to the topics listed below:

16.9.4.1 The health and psychosocial needs of the population being served;

16.9.4.2 The resident assessment process;

16.9.4.3 Use of service agreements;

16.9.4.4 Cuing, coaching, and monitoring residents who self-administer medications, with or without assistance;

16.9.4.5 Providing assistance with ambulation, personal hygiene, dressing, toileting, and feeding;

16.9.4.6 16 Del.C. Ch. 11, pertaining to resident’s rights; reporting of abuse, neglect, mistreatment, and financial exploitation; and the Ombudsman Program;

16.9.4.7 Fire and life safety, and emergency disaster plans;

16.9.4.8 Infection control, including Standard Precautions;

16.9.4.9 Basic food safety;

16.9.4.10 Basic first aid, CPR, and the Heimlich Maneuver; and

16.9.4.11 Hospice services.

16.10 Assisted living facilities administering therapies and/or treatments shall have staff adequate in number and appropriately qualified and/or licensed.

16.11 Every assisted living facility shall have a Director of Nursing who is a registered nurse. Facilities licensed for 25 assisted living beds or more shall have a full-time Director of Nursing. Facilities licensed for 5 through 24 assisted living beds shall have a part-time Director of Nursing on-site and on-duty at least 20 hours a week. The nursing director of a facility for 4 assisted living beds or fewer shall be on-site at least 8 hours a week.

16.12 The Director of Nursing shall comply with the provisions of 24 Del.C. Ch. 19 and the rules and regulations of the Board of Nursing.

16.13 The Director of Nursing shall have overall responsibility for the coordination, supervision and provision of the nursing department /services.

16.14 Assisted living facility resident assistants shall, at a minimum:

16.14.1 Be at least 18 years old;

16.14.2 Participate in a facility-specific orientation program that covers the following topics:

16.14.2.1 Fire and life safety, and emergency disaster plans;

16.14.2.2 Infection control, including Standard Precautions;

16.14.2.3 Basic food safety;

16.14.2.4 Basic first aid and the Heimlich Maneuver;

16.14.2.5 Job responsibilities;

16.14.2.6 The health and psychosocial needs of the population being served;

16.14.2.7 The resident assessment process; and

16.14.2.8 The use of service agreements;

16.14.2.9 16 Del.C. Ch. 11, pertaining to residents’ rights; reporting of abuse, neglect, mistreatment, and financial exploitation; and the Ombudsman Program;

16.14.2.10 Hospice services.

16.14.3 Receive, at a minimum, 12 hours of regular in-service education annually which may include but not be limited to the topics listed in 16.14.2;

16.14.4 Receive training to competently assist in activities of daily living or provide documentation of such training, and

16.14.5 Complete a Delaware Board of Nursing-approved AWSAM training course if assisting with self-administration of medications.

16.15 The assisted living facility shall have a staffing plan which shall specify supervisory responsibilities, including the person responsible in the Assisted Living Director’s absence.

16.16 The assisted living facility shall maintain staffing records which document what personnel were on duty as well as specific hours worked for each day.

16.17 The assisted living facility shall maintain a copy of each employee’s signature and handwritten initials.

16.18 The assisted living facility shall maintain records of each employee’s regular in-service education hours.

16.19 The assisted living facility shall provide orientation training to all new staff.

16.20 Temporary agency staff placed in a facility in which they have not worked within the past 6 months shall undergo an orientation prior to beginning their first shift. The orientation shall cover the following topics:

16.20.1 Tour of the facility;

16.20.2 Fire and disaster plans;

16.20.3 Emergency equipment and supplies;

16.20.4 Communication and documentation requirements of the facility;

16.20.5 Process for reporting emergencies and change of condition; and

16.20.6 Review of current assigned resident issues/ needs.

16.21 All personnel records for permanent employees, including employment applications, shall be maintained for a minimum of five years consistent with the assisted living facility policies and applicable state laws.

16.22 At a minimum, every assisted living facility shall have an awake staff person on-site 24 hours per day who is qualified to administer or assist with self-administration of medication (“AWSAM”) and who has knowledge of emergency procedures, basic first aid, CPR, and the Heimlich Maneuver.

16.23 Written policies and procedures shall be required and adhered to for any assisted living facility utilizing volunteers.

**History**
- *8 DE Reg. 85 (07/01/04)*
- *15 DE Reg. 81 (07/01/11)*
- *15 DE Reg. 1156 (02/01/12)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*
- *8 DE Reg. 85 (07/01/04)*
- *13 DE Reg. 1328 (04/01/10)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 192 (08/01/11)*
- *15 DE Reg. 81 (07/01/11)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 81 (07/01/11)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 81 (07/01/11)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*
- *13 DE Reg. 1328 (04/01/10)*
- *13 DE Reg. 1328 (04/01/10)*
- *8 DE Reg. 85 (07/01/04)*
- *16 DE Reg. 865 (02/01/13)*
- *24 DE Reg. 579 (12/01/20)*
- *8 DE Reg. 85 (07/01/04)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 1156 (02/01/12)*
- *6 DE Reg. 525 (10/01/02)*
- *14 DE Reg. 1190 (05/01/11)*
- *15 DE Reg. 81 (07/01/11)*
- *15 DE Reg. 1156 (02/01/12)*
- *16 DE Reg. 865 (02/01/13)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*

##### **16 Del. Admin. Code § 3225-17.0** Environment and Physical Plant {#sec-3225-17.0 omnilex-key=us-de-regs-official--title-16--3225-17.0}

17.1 Each assisted living facility shall comply with applicable federal, state and local laws including:

17.1.1 Rehabilitation Act, Section 504;

17.1.2 Fair Housing Act as amended; and

17.1.3 Americans with Disabilities Act.

17.2 Assisted living facilities shall:

17.2.1 Be in good repair;

17.2.2 Be clean;

17.2.3 Have a hazard-free environment; and

17.2.4 Have an effective pest control program.

17.3 Heating and cooling systems in common areas shall be maintained at a temperature between 71°F and 81°F. A resident with an individual temperature-controlled residential room or unit may heat and cool to provide individual comfort.

17.4 Common areas shall be lighted to assure resident safety.

17.5 For all new construction and conversions of assisted living facilities with more than 10 beds, there shall be at least 100 square feet of floor space, excluding alcoves, closets, and bathroom, for each resident in a private bedroom and at least 80 square feet of floor space for each resident sharing a bedroom.

17.5.1 Sharing of a bedroom shall be limited to 2 residents;

17.5.2 Each facility shall have locked storage available for the resident’s valuables, in accordance with the facility’s policies;

17.5.3 Bedrooms and all bathrooms used by residents in assisted living facilities, except in specialized care units for memory impairment, shall be equipped with an intercom or other mechanical means of communication for resident emergencies. For specialized care units for memory impairment, staff must be equipped to communicate resident emergencies immediately.

17.6 Resident kitchens shall be available to residents either in their individual living unit or in an area readily accessible to each resident. Residents shall have access to a microwave or stove/conventional oven, refrigerator, and sink. The assisted living facility shall establish and adhere to policies and procedures to ensure that common kitchens are used and maintained in such a way as to provide:

17.6.1 A clean and sanitary environment;

17.6.2 Safe storage of food; and

17.6.3 A means to enable hand washing and sanitizing of dishes, utensils and food preparation equipment.

17.7 Bathroom facilities shall be available to residents either in their individual living units or in an area readily accessible to each resident. There shall be at least 1 working toilet, sink, and tub/shower for every 4 residents.

17.8 Hot water at resident bathing and hand-washing facilities shall not exceed 120 degrees Fahrenheit.

**History**
- *8 DE Reg. 85 (07/01/04)*
- *15 DE Reg. 81 (07/01/11)*
- *15 DE Reg. 1156 (02/01/12)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*
- *8 DE Reg. 85 (07/01/04)*
- *13 DE Reg. 1328 (04/01/10)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 192 (08/01/11)*
- *15 DE Reg. 81 (07/01/11)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 81 (07/01/11)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 81 (07/01/11)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*
- *13 DE Reg. 1328 (04/01/10)*
- *13 DE Reg. 1328 (04/01/10)*
- *8 DE Reg. 85 (07/01/04)*
- *16 DE Reg. 865 (02/01/13)*
- *24 DE Reg. 579 (12/01/20)*
- *8 DE Reg. 85 (07/01/04)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 1156 (02/01/12)*
- *6 DE Reg. 525 (10/01/02)*
- *14 DE Reg. 1190 (05/01/11)*
- *15 DE Reg. 81 (07/01/11)*
- *15 DE Reg. 1156 (02/01/12)*
- *16 DE Reg. 865 (02/01/13)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*

##### **16 Del. Admin. Code § 3225-18.0** Emergency Preparedness {#sec-3225-18.0 omnilex-key=us-de-regs-official--title-16--3225-18.0}

18.1 Nursing facilities shall comply with the rules and regulations adopted and enforced by the State Fire Prevention Commission or the municipality with jurisdiction.

18.2 Regular fire drills shall be held at least quarterly on each shift. Written records shall be kept of attendance at such drills.

18.3 Each facility shall develop and maintain all-hazard emergency plans for evacuation and sheltering in place. The plan must be submitted to the Division and DEMA in a digital format and it must conform to the template prescribed by the Division. The all-hazard emergency plan must include plans to address staffing shortages and facility demands.

18.4 The staff on all shifts shall be trained on emergency and evacuation plans. Evacuation routes shall be posted in a conspicuous place at each nursing station.

18.5 In the event of a facility evacuation, the evacuation plan shall, at a minimum, provide for the transfer or availability of resident medications and records.

18.6 Each facility shall submit with an application for a license and annual renewal of a license:

18.6.1 A current all hazards emergency plan, and

18.6.2 Copies of the FEMA certificate of achievement which demonstrate that at least two active, full-time employees have completed FEMA training in ICS-100 and NIMS-700a in the past 24 months.

18.7 The Division may grant an extension of time for either requirement in 18.6 upon request and for good cause shown.

**History**
- *8 DE Reg. 85 (07/01/04)*
- *15 DE Reg. 81 (07/01/11)*
- *15 DE Reg. 1156 (02/01/12)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*
- *8 DE Reg. 85 (07/01/04)*
- *13 DE Reg. 1328 (04/01/10)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 192 (08/01/11)*
- *15 DE Reg. 81 (07/01/11)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 81 (07/01/11)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 81 (07/01/11)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*
- *13 DE Reg. 1328 (04/01/10)*
- *13 DE Reg. 1328 (04/01/10)*
- *8 DE Reg. 85 (07/01/04)*
- *16 DE Reg. 865 (02/01/13)*
- *24 DE Reg. 579 (12/01/20)*
- *8 DE Reg. 85 (07/01/04)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 1156 (02/01/12)*
- *6 DE Reg. 525 (10/01/02)*
- *14 DE Reg. 1190 (05/01/11)*
- *15 DE Reg. 81 (07/01/11)*
- *15 DE Reg. 1156 (02/01/12)*
- *16 DE Reg. 865 (02/01/13)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*

##### **16 Del. Admin. Code § 3225-19.0** Records and Reports {#sec-3225-19.0 omnilex-key=us-de-regs-official--title-16--3225-19.0}

19.1 The assisted living facility shall be responsible for maintaining appropriate records for each resident. These records shall document the implementation of the service agreement for each resident.

19.2 Records shall be available, along with the equipment to read them if electronically maintained, at all times to legally authorized persons; otherwise such records shall be held confidential.

19.3 The assisted living facility resident clinical records shall be retained for a minimum of 5 years following discharge or 3 years after death before being destroyed.

19.4 In cases in which facilities have created the option for an individual’s record to be maintained by computer, rather than hard copy, electronic signatures shall be acceptable. In cases when such attestation is done on computer records, safeguards to prevent unauthorized access and reconstruction of information must be in place. The following is an example of how such a system may be set up:

19.4.1 There is a written policy, at the assisted living facility, describing the attestation policy(ies) force at the facility;

19.4.2 The computer has built-in safeguards to minimize the possibility of fraud;

19.4.3 Each person responsible for an attestation has an individualized identifier;

19.4.4 The date and time is recorded from the computer’s internal clock at the time of entry;

19.4.5 An entry is not to be changed after it has been recorded; and

19.4.6 The computer program controls what sections/ areas any individual can access/enter data based on the individual’s personal identifier.

19.5 Incident reports, with adequate documentation, shall be completed for each incident. Records of incident reports shall be retained in facility files for the following:

19.5.1 All reportable incidents.

19.5.2 Falls without injury and falls with injuries that do not require transfer to an acute care facility or do not require reassessment of the resident.

19.5.3 Errors or omissions in treatment or medication.

19.5.4 Injuries of unknown source.

19.5.5 Lost items, in accordance with facility policy, which are not subject to financial exploitation. Adequate documentation shall consist of the name of the resident(s) involved; the date, time and place of the incident; a description of the incident; a list of other parties involved, including witnesses and any accused persons; the nature of any injuries; resident outcome; and follow-up action, including notification of the resident’s representative or family, attending physician and licensing or law enforcement authorities when appropriate.

19.6 Reportable incidents shall be reported immediately, which shall be within 8 hours of the occurrence of the incident, to the Division. The method of reporting shall be as directed by the Division.

19.7 Reportable incidents include:

19.7.1 Abuse as defined in 16 Del.C. §1131.

19.7.1.1 Physical abuse.

19.7.1.1.1 Staff to resident with or without injury.

19.7.1.1.2 Resident to resident with or without injury.

19.7.1.1.3 Other (e.g., visitor, relative) to resident with or without injury.

19.7.1.2 Sexual abuse.

19.7.1.2.1 Staff to resident sexual acts.

19.7.1.2.2 Resident to resident non-consensual sexual acts.

19.7.1.2.3 Other (e.g., visitor, relative) to resident non-consensual sexual acts.

19.7.1.3 Emotional abuse.

19.7.1.3.1 Staff to resident.

19.7.1.3.2 Resident to resident.

19.7.1.3.3 Other (e.g., visitor, relative) to resident.

19.7.2 Neglect as defined in 16 Del.C. §1131.

19.7.3 Mistreatment as defined in 16 Del.C. §1131.

19.7.4 Financial exploitation as defined in 16 Del.C. §1131.

19.7.5 Resident elopement.

19.7.5.1 Any circumstance in which a resident’s whereabouts are unknown to staff and the resident suffers harm.

19.7.5.2 Any circumstance in which a cognitively impaired resident, whose whereabouts are unknown to staff, exits the facility.

19.7.5.3 Any circumstance in which a resident cannot be found inside or outside a facility and the police are summoned.

19.7.6 Death of a resident in a facility or within 5 days of transfer to an acute care facility.

19.7.7 Significant injuries.

19.7.7.1 Injury from an incident of unknown source in which the initial investigation concludes that there is reasonable basis to suspect that the injury is suspicious. An injury is suspicious based on; the extent of the injury, the location of the injury (e.g., the injury is located in an area not generally vulnerable to trauma), the number of injuries observed at one particular point in time or the incidence of injuries over time.

19.7.7.2 Injury from a fall which results in transfer to an acute care facility for treatment or evaluation or which requires periodic reassessment of the resident’s clinical status by facility professional staff for up to 48 hours.

19.7.7.3 Injury sustained while a resident is physically restrained.

19.7.7.4 Injury sustained by a resident dependent on staff for toileting, mobility, transfer and/or bathing.

19.7.7.5 Medication error or omission which causes or prolongs the resident’s discomfort, jeopardizes the resident’s health or safety, or requires periodic reassessment of the resident’s clinical status by facility professional staff.

19.7.7.6 Treatment error or omission which causes or prolongs the resident’s discomfort, jeopardizes the resident’s health or safety, or requires periodic reassessment of the resident’s clinical status by facility professional staff.

19.7.7.7 A burn greater than first degree.

19.7.7.8 Choking resulting in transfer to an acute care facility.

19.7.7.9 Areas of contusions or lacerations which may be attributable to abuse or neglect.

19.7.7.10 Serious unusual and/or life-threatening injury.

19.7.8 Attempted suicide.

19.7.9 Poisoning.

19.7.10 Epidemic outbreak or quarantine.

19.7.11 Circumstances which provide a reasonable basis to suspect that a resident’s drugs have been diverted.

19.7.12 Utility interruption lasting more than 8 hours in one or more major service including electricity, water supply, plumbing, heating or air conditioning, fire alarm, sprinkler system or telephone system.

19.7.13 Structural damage or unsafe structural conditions.

19.7.13.1 Structural damage to a facility due to natural disasters such as hurricanes, tornadoes, flooding or earthquakes.

19.7.13.2 Water damage which impacts resident health, safety or comfort.

**History**
- *8 DE Reg. 85 (07/01/04)*
- *15 DE Reg. 81 (07/01/11)*
- *15 DE Reg. 1156 (02/01/12)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*
- *8 DE Reg. 85 (07/01/04)*
- *13 DE Reg. 1328 (04/01/10)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 192 (08/01/11)*
- *15 DE Reg. 81 (07/01/11)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 81 (07/01/11)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 81 (07/01/11)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*
- *13 DE Reg. 1328 (04/01/10)*
- *13 DE Reg. 1328 (04/01/10)*
- *8 DE Reg. 85 (07/01/04)*
- *16 DE Reg. 865 (02/01/13)*
- *24 DE Reg. 579 (12/01/20)*
- *8 DE Reg. 85 (07/01/04)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 1156 (02/01/12)*
- *6 DE Reg. 525 (10/01/02)*
- *14 DE Reg. 1190 (05/01/11)*
- *15 DE Reg. 81 (07/01/11)*
- *15 DE Reg. 1156 (02/01/12)*
- *16 DE Reg. 865 (02/01/13)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*

##### **16 Del. Admin. Code § 3225-20.0** Waivers and Severability {#sec-3225-20.0 omnilex-key=us-de-regs-official--title-16--3225-20.0}

20.1 Waivers may be granted by the Division for good cause.

20.2 Should any section, sentence, clause or phrase of these regulations be legally declared unconstitutional or invalid for any reason, the remainder of said regulations shall not be affected thereby.

**History**
- *8 DE Reg. 85 (07/01/04)*
- *15 DE Reg. 81 (07/01/11)*
- *15 DE Reg. 1156 (02/01/12)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*
- *8 DE Reg. 85 (07/01/04)*
- *13 DE Reg. 1328 (04/01/10)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 192 (08/01/11)*
- *15 DE Reg. 81 (07/01/11)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 81 (07/01/11)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 81 (07/01/11)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*
- *13 DE Reg. 1328 (04/01/10)*
- *13 DE Reg. 1328 (04/01/10)*
- *8 DE Reg. 85 (07/01/04)*
- *16 DE Reg. 865 (02/01/13)*
- *24 DE Reg. 579 (12/01/20)*
- *8 DE Reg. 85 (07/01/04)*
- *13 DE Reg. 1328 (04/01/10)*
- *15 DE Reg. 1156 (02/01/12)*
- *6 DE Reg. 525 (10/01/02)*
- *14 DE Reg. 1190 (05/01/11)*
- *15 DE Reg. 81 (07/01/11)*
- *15 DE Reg. 1156 (02/01/12)*
- *16 DE Reg. 865 (02/01/13)*
- *24 DE Reg. 579 (12/01/20)*
- *25 DE Reg. 761 (02/01/22)*

#### **3230** Rest (Residential) Home Regulations

##### **16 Del. Admin. Code § 3230-1.0** Scope {#sec-3230-1.0 omnilex-key=us-de-regs-official--title-16--3230-1.0}

1.1 "Rest (Residential) Home" is a facility that provides resident beds and personal care services in a homelike environment for persons who are normally able to manage activities of daily living. The home should provide friendly understanding to persons living there as well as appropriate supportive care in order that the resident's self-esteem, self-image, and role as a contributing member of the community may be reinforced. The regulations contained here within are based on the common needs of the rest (Residential) care recipients and are minimal health standards.

1.2 The facility must be in compliance with all State and local laws and regulations applicable to the facility's personnel, provision of services and the physical plant.

**History**
- *24 DE Reg. 584 (12/01/20)*
- *24 DE Reg. 584 (12/01/20)*
- *24 DE Reg. 584 (12/01/20)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 192 (08/01/11)*
- *16 DE Reg. 637 (12/01/12)*
- *24 DE Reg. 584 (12/01/20)*

##### **16 Del. Admin. Code § 3230-2.0** Definitions {#sec-3230-2.0 omnilex-key=us-de-regs-official--title-16--3230-2.0}

“Activities of Daily Living" ("ADLs") means normal daily activities including but not limited to ambulating, transferring, range of motion, grooming, bathing, dressing, eating, and toileting.

“Continuous” means available at all times without cessation, break or interruption.

“Direction” means authoritative policy or procedural guidance for the accomplishment of a function or activity.

“Department” means Department of Health and Social Services

“Division” means Division of Long Term Care Residents Protection.

“Facility” means the site, physical structure and equipment necessary to provide the required services.

“Homelike” means having the qualities of a home, including privacy, comfortable surroundings supported by the use of residential building materials and furnishings, and the opportunity to modify one's living area to suit one's individual preferences, in accordance with the facility's policies. A homelike environment provides residents with an opportunity for self-expression and encourages interaction with community, family, and friends.

“Incident” means an occurrence or event, a record of which must be maintained in facility files, which includes all reportable incidents and the additional occurrences or events listed in Section 10.6 and 10.7 of these regulations. (Also see Reportable Incident, 10.7)

“Legal Representative” means a resident's guardian, agent acting through a power of attorney, advanced health care directive or similar document or authorized representative pursuant to Title 16 Del.C. §1121(34) and 1122.

“Licensed Nurse” means an individual who has the "authorization to practice nursing within this State granted by the Delaware Board of Nursing and includes the authorization to practice in Delaware under the Interstate Nurse Licensure Compact" Title 24 Del.C. §1902(h).

“Licensed Nursing Home Administrator” means a person who is licensed by the Board of Examiners of Nursing Home Administrators of the State of Delaware.

“Nurse Aide/Nurse Assistant/Resident Assistant” means an individual who provides care that does not require the judgment and skills of a licensed nurse. The care may include but is not limited to the following: bathing, dressing, grooming, toileting, ambulating, transferring and feeding, observing and reporting the general well being of the resident for whom care is provided.

“Personal Care Services” means those services that include general supervision of, and direct assistance to, individuals in their activities of daily living to ensure their safety, comfort, nutritional needs and well being.

“Physician" means an allopathic doctor of medicine and surgery or a doctor of osteopathic medicine and surgery who is registered and certified to practice medicine" pursuant to 24 Del.C. §1702(8).

“Rehabilitation” means the restoration of an ill or injured person to self sufficiency at his or her highest attainable level.

“Reportable Incident” means an occurrence or event which must be reported immediately to the Division and for which there is reasonable cause to believe that a resident has been abused, neglected, mistreated or subjected to financial exploitation as those terms are defined in 16 Del.C. §1131. Reportable incident also includes an occurrence or event listed in Section 10.7 of these regulations.

“Resident” means an individual 18 years old or older who lives in a Rest Residential Home. Where appropriate in the context of these regulations, "resident" as used herein includes a legal representative as defined in 2.0.

“Resident Beds” means accommodations with supportive services (such as: food, laundry and housekeeping) for persons who generally stay in excess of twenty four (24) hours.

“Supervision” means direct overseeing and inspection of the act of accomplishing a function or activity by a responsible person who is not a resident.

“Vendor” means any individual who is not employed by the facility but provides direct services to one or more facility residents.

**History**
- *24 DE Reg. 584 (12/01/20)*
- *24 DE Reg. 584 (12/01/20)*
- *24 DE Reg. 584 (12/01/20)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 192 (08/01/11)*
- *16 DE Reg. 637 (12/01/12)*
- *24 DE Reg. 584 (12/01/20)*

##### **16 Del. Admin. Code § 3230-3.0** General Requirements {#sec-3230-3.0 omnilex-key=us-de-regs-official--title-16--3230-3.0}

3.1 The term "Rest Residential Home" shall not be used as part of the name of any facility in this State unless it has been so licensed by the Division.

3.2 Each Rest Residential Home shall develop written policies pertaining to the services provided.

3.3 A Rest Residential Home shall not adopt any policy which conflicts with applicable statutes or regulations.

3.4 Inspections and monitoring by the Division shall be carried out in accordance with 16 Del.C. §1107.

3.5 Upon receipt of a report of any violation(s) of these regulations, the facility shall submit a written plan of action to correct cited deficiencies within 10 working days or such other time period as may be specified. The plan of action shall address corrective actions and include all measures and completion dates to prevent their recurrence as follows:

3.5.1 How the corrective action will be accomplished for a resident(s) affected by the deficient practice;

3.5.2 How the facility will identify other residents having the potential to be affected by the same deficient practice;

3.5.3 What measures or systemic changes will be put in place to ensure that the deficient practice will not recur;

3.5.4 What program will be put into place to monitor the continued effectiveness of the corrective actions.

3.6 The Division shall be notified, in writing, upon any changes in the administrator, assistant administrator or director of nursing positions.

3.7 The Rest Residential Home shall comply with 16 Del.C. §1121 regarding the rights of residents. Those rights shall be made available in writing to residents, guardians, representatives or next of kin.

3.8 Each facility shall provide, in writing, the refund and prepayment policy at the time of admission, and in the case of residents admitted while awaiting approval of third-party payment, an exact statement of responsibility in the event of retroactive denial. The facility shall notify residents, in writing, at least 30 days prior to a rate increase.

3.9 A facility may require an individual who has legal access to a resident's income or resources available to pay for facility care to sign a contract to provide for facility payment from the resident's income or resources. However, in doing so, the facility shall not require the individual to incur personal financial liability for the facility expenses.

3.10 The Residential Home shall cooperate fully with the state protection and advocacy agency, as defined in 16 Del.C. §1102(7), in fulfilling functions authorized by Title 16, Chapter 11.

3.11 The Patient's Bill of Rights (Title 16) is posted in a conspicuous location within the residence to ensure easy access by individuals served.

**History**
- *24 DE Reg. 584 (12/01/20)*
- *24 DE Reg. 584 (12/01/20)*
- *24 DE Reg. 584 (12/01/20)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 192 (08/01/11)*
- *16 DE Reg. 637 (12/01/12)*
- *24 DE Reg. 584 (12/01/20)*

##### **16 Del. Admin. Code § 3230-4.0** Licensing Requirements and Procedures {#sec-3230-4.0 omnilex-key=us-de-regs-official--title-16--3230-4.0}

4.1 Licenses and renewals shall be issued to a Rest Residential Home which meets the requirements of 16 Del.C. §1104. For initial licensure, the Rest Residential Home shall also demonstrate during a physical inspection of the premises that the facility complies with all applicable regulations.

4.2 The Division shall consider the applicant's compliance history in determining licensure eligibility. Accordingly, the applicant shall disclose the following;

4.2.1 The imposition of temporary management by any state jurisdiction against the applicant or associated entity during the preceding five years

4.2.2 The imposition of immediate jeopardy against the applicant or associated entity during the preceding five years

4.2.3 A substandard survey by any state jurisdiction against the applicant or associated entity during the preceding five years

4.2.4 The imposition of a civil money penalty by any state jurisdiction against the applicant or associated entity during the preceding five years

4.2.5 A ban on admissions by any state jurisdiction against the applicant or associated entity during the preceding five years

4.2.6 A list of all facilities managed, owned or controlled by the applicant or associated entity in any jurisdiction during the preceding five years

4.2.7 Information as required by 16 Del.C. §1104(e)

4.2.8 The disclosure shall be supported by a sworn affidavit pursuant to 16 Del.C. §1104(d).

4.3 Financial information disclosed to the Division as required by 16 Del.C. §1104(e) shall not be subject to Freedom of Information Act requests except as follows;

4.3.1 Any information known to the Division regarding a civil action for debt owed by a facility

4.3.2 Any information known to the Division regarding current facility bankruptcy proceedings

4.3.3 The name of any facility currently under intensive Division review for potential financial incapability

4.4 Each license shall be renewed on the anniversary date of initial licensure or as directed by the Division. Each license holder shall file an application for renewal at least 30 days prior to the expiration of the current license and pay the applicable fee as established in 16 Del.C. §1106(a).

4.5 A new license shall be required in the event of a change in the Rest Residential Home management company, building owner or controlling person as defined in 16 Del.C. §1102(1).

4.6 Each license shall specify the number of licensed beds. A facility seeking to change the number of licensed beds shall apply to the Division for a modified license authorizing the revised number of beds.

4.7 Separate licenses are required for facilities maintained in separate locations, even though operated under the same management.

4.8 When a facility plans to construct or extensively remodel a licensed facility or convert a building to a licensed facility, it shall submit one copy of properly prepared plans and specifications for the entire facility to the Division. An approval, in writing, shall be obtained before such work is begun. After the work is completed, in accordance with the plans and specifications, a modified license to operate shall be issued. All completed construction, extensive remodeling or conversions shall remain in accordance with the plans and specifications, as approved by the Division.

**History**
- *24 DE Reg. 584 (12/01/20)*
- *24 DE Reg. 584 (12/01/20)*
- *24 DE Reg. 584 (12/01/20)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 192 (08/01/11)*
- *16 DE Reg. 637 (12/01/12)*
- *24 DE Reg. 584 (12/01/20)*

##### **16 Del. Admin. Code § 3230-5.0** Plant, Equipment and Physical Environment {#sec-3230-5.0 omnilex-key=us-de-regs-official--title-16--3230-5.0}

5.1 Site Provisions. Each Rest Residential Home shall be located on a site which is considered suitable by the Department of Health and Social Services. Site must have good drainage, be suitable for disposal of sewage and provide a potable water supply.

5.2 Water Supply and Sewage Disposal:

5.2.1 The water supply and the sewage disposal system shall be approved by the Division of Public Health and the Department of Natural Resources and Environmental Control, respectively.

5.2.2 The water system shall be designed to supply adequate hot and cold water, under pressure, at all times.

5.3 Building:

5.3.1 All new construction, extensive remodeling or conversions shall comply with the applicable parts of the standards as set forth under the most recent edition of the Guidelines for Design and Construction of Health Care Facilities, a publication of the Department of Health, and Human Services, and its amendments.

5.3.2 Existing Facilities shall have:

5.3.2.1 Window space shall not be less than one-tenth (1/10) of the floor space. Up to a twenty-five (25%) reduction can be allowed when approved mechanical ventilation, is utilized in multi-bedrooms.

5.3.2.2 All windows in rooms to be used by residents are to be so constructed to eliminate drafts and to provide adequate light and ventilation.

5.3.2.3 Residents' rooms shall open directly into a corridor.

5.3.2.4 Existing facilities accommodating residents who regularly require wheelchairs shall comply with the Americans With Disabilities Act standards.

5.4 The plumbing shall meet the requirements of all municipal and county codes. Where there are no local codes, the provisions of the Division of Public Health's Sanitary Plumbing Code shall prevail.

5.5 Heating and cooling systems (HVAC) in common areas shall be maintained at a temperature between 71°F and 81°F. A resident with an individual temperature controlled residential room or unit may heat and cool to provide individual comfort.

5.6 Lighting. Each room shall be suitably lighted at all times for maximum safety, comfort, sanitation and efficiency of operation. A minimum of thirty (30) foot candles of light shall be provided for all working and reading surfaces, and a minimum of ten (10) foot candles of light on all other areas. This includes hallways, stairways, storerooms, and bathrooms.

5.7 Safety Equipment:

5.7.1 To prevent slipping, staircases shall have stair treads and sturdy handrails.

5.7.2 Stairways shall be well lighted, with electric switches at both the top and bottom or continuous illumination or motion activated illumination.

5.7.3 Hallways shall have night lights

5.7.4 Low windows, open porches, changes in floor levels and areas on the ground shall not present safety hazards.

5.7.5 Floor surfaces shall not be slippery and shall be kept in good repair. If rugs are used, they should be free of such hazards as curled edges, rips or potential for slipping.

5.7.6 All doors for areas used by residents shall be capable of being opened from either side and comply with the Americans With Disabilities Act standards.

5.8 Bedrooms:

5.8.1 Each bedroom shall be well lighted and well ventilated. Each bedroom shall be an outside room with at least one (1) window opening directly to the outside. The window sill shall be no more than three (3) feet above the floor and above grade. Windows shall be so constructed as to allow a maximum of sunlight and air and to eliminate drafts, and easy to open and close.

5.8.2 Bedrooms for one (1) person shall be at least one hundred (100) square feet in size and bedrooms for more than one (1) person shall provide eighty (80) square feet of floor space per person, and be arranged for comfort. The ceiling shall not be less than seven (7) feet from the floor.

5.8.3 Each bedroom is to have walls that go to the ceiling, and have a door that can be closed.

5.8.4 The beds shall be at least four (4) feet apart in multi bedrooms.

5.8.5 Adequate electrical outlets shall be conveniently located in each bedroom. A reading light shall be provided for each resident. At least one (1) light fixture shall be switched at the entrance of each bedroom.

5.8.6 Walls shall be finished in colors which are light and cheerful.

5.8.7 Facilities shall ensure adequate privacy.

5.8.8 The maximum capacity per bedroom shall be two (2) residents.

5.9 Bathrooms:

5.9.1 Bathrooms shall be constructed so that the walls and floors are impervious to water. At least one (1) window or mechanical ventilation to the outside shall be provided. Floors shall not be slippery.

5.9.2 Bathtubs or showers shall be provided at the rate of one (1) for every four (4) residents. Each tub or shower shall be located in an individual room or enclosure which provides space for the private use or the bathing fixture and for drying and dressing.

5.9.3 At least one (1) toilet for every four (4) residents and one (1) washbasin, with hot and cold water, for every four (4) residents shall be located on the floor occupied by the residents. When more than one (1) toilet is located in the same room, provisions for private use shall be made.

5.9.4 Each toilet, bathtub or shower used by residents shall be provided with a substantial hand-grip.

5.9.5 Hot water as shower, bathing and hand-washing facilities shall not exceed 115 degrees Fahrenheit.

5.10 Dayroom and Dining Area:

5.10.1 There shall be provided one (1) or more areas that are adequate in size and furnished for resident dining, recreational and social activities. At least thirty (30) square feet per resident will be assigned to these areas.

5.10.2 When a multi purpose room is used, it shall have sufficient space to prevent interference of one activity with another.

5.11 Kitchen and Food Storage Areas. Facilities shall comply with the Delaware Food Code.

5.12 Sanitation and Housekeeping:

5.12.1 Waste materials, obsolete and unnecessary articles, tin cans, rubbish and other litter shall not be permitted to accumulate on the premises of the home.

5.12.2 All rooms and every part of the building shall be kept clean, orderly and free of offensive odors.

5.12.3 Infectious waste shall be stored in sanitary containers and disposed of in a sanitary manner.

5.12.4 When a separate sink is not provided for janitorial duties, the sink shall be sanitized after each use.

5.12.5 No laundry or janitorial operations can be carried out where food is prepared, served or stored.

5.12.6 If linen chutes are used, they will be provided with adequate means of cleaning.

5.12.7 All areas used for soiled linen are to be vented outside and have a higher air removal rate than the surrounding area.

5.12.8 The laundry room shall provide for keeping the soiled linen separate from the clean, and have hand washing facilities accessible to this area. The laundry shall contain equipment sufficient to take care of a minimum of seven (7) days' needs. A laundry room is not required if all laundry is processed outside the facility.

5.12.9 All bathrooms shall include hand washing facilities, soap and individual towels.The water temperature shall not exceed 115 degrees Fahrenheit.

5.12.10 The facility shall contract with a licensed pest control vendor to ensure that the entire facility is free of live insects and other vermin. Preventive measures for insect and rodent control must be in effect. All exterior openings used for outside ventilation shall be effectively screened during the fly season. Screen doors shall open outward. All screening shall have at least sixteen (16) mesh per inch.

5.13 Equipment and Supplies:

5.13.1 Each resident shall be provided with:

5.13.1.1 A bed in good repair and having a comfortable, well constructed mattress. This mattress shall be covered or protected with non porous material.

5.13.1.2 A bedside stand.

5.13.1.3 A minimum of two (2) drawers in a chest of drawers.

5.13.1.4 A private and enclosed space of at least two (2) linear feet for hanging clothing.

5.13.1.5 A chair.

5.13.1.6 A means of communication shall be provided for residents to alert staff.

**History**
- *24 DE Reg. 584 (12/01/20)*
- *24 DE Reg. 584 (12/01/20)*
- *24 DE Reg. 584 (12/01/20)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 192 (08/01/11)*
- *16 DE Reg. 637 (12/01/12)*
- *24 DE Reg. 584 (12/01/20)*

##### **16 Del. Admin. Code § 3230-6.0** Emergency Preparedness {#sec-3230-6.0 omnilex-key=us-de-regs-official--title-16--3230-6.0}

6.1 Rest Residential Homes shall comply with the rules and regulations adopted and enforced by the State Fire Prevention Commission or the municipality with jurisdiction. Evidence of written notification of compliance with the Rules and Regulations of the State Fire Prevention Commission shall be provided to the Division to obtain an initial license. Written notification to the Division by the State Fire Marshal of noncompliance with these Rules and Regulations shall be grounds for revocation of license.

6.2 Regular fire drills shall be held at least quarterly on each shift. Written records shall be kept of attendance at such drills.

6.3 Each facility shall develop and maintain all-hazard emergency plans for evacuation and sheltering in place. The emergency plan shall conform to the template provided by the Division. The all-hazard emergency plan must include plans to address staffing shortages and facility demands.

6.4 The staff on all shifts shall be trained on emergency and evacuation plans. Evacuation routes shall be posted in a conspicuous place at each nursing station.

6.5 Each facility shall submit its all hazards emergency plan with their annual license renewal unless a different time is directed by the Division.

**History**
- *24 DE Reg. 584 (12/01/20)*
- *24 DE Reg. 584 (12/01/20)*
- *24 DE Reg. 584 (12/01/20)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 192 (08/01/11)*
- *16 DE Reg. 637 (12/01/12)*
- *24 DE Reg. 584 (12/01/20)*

##### **16 Del. Admin. Code § 3230-7.0** Personnel/Administrative {#sec-3230-7.0 omnilex-key=us-de-regs-official--title-16--3230-7.0}

7.1 Administrator:

7.1.1 All administrators must be licensed by the Board of Examiners of Nursing Home Administrators. Administrators in a facility of 25 beds or more must be a full time employee. Administrators in a facility of 25 beds or less must be on duty at least 4 hours per day, 5 days per week. When an administrator is responsible for more than one licensed entity on the same campus, the criteria for the highest level of care would determines the administrator requirements for the entire facility.

7.1.2 The administrator enforces the rules and regulations relating to the level of health care and safety of residents, and to the protection of their personal. and property rights.

7.1.3 The administrator plans, organizes and directs the overall responsibilities of the facility.

7.1.4 The administrator of a resident care facility shall be physically and mentally capable of performing the duties and responsibilities of the job.

7.1.5 In the absence of the administrator, an employee shall be authorized in writing, to act on the administrator's behalf.

7.2 Nursing Services

7.2.1 The licensed nurse shall administer medications to residents who do not self administer.

7.2.2 The Licensed Nurse shall ensure that an onsite review of the resident's cognitive ability is completed as specified in sections 8.1.6 and 8.1.7 for those residents who self medicate.

7.2.3 The licensed nurse shall ensure that an on-site medication review is conducted as specified in section 8.1.8.

7.2.4 Nursing and Nurse Aide/Nurse Assistant/Resident Assistant staff sufficient in number and adequately trained to meet the requirements of the residents shall be employed and must provide to at least 1.75 hours direct care per twenty four (24) hour period, per resident.

7.3 The Rest Residential Home shall have written personnel policies and procedures that support sound resident care. An application for employment and personnel records shall be maintained for all employees.

7.4 No person having a communicable disease shall be permitted to give care or service. All reportable communicable diseases shall be reported to the Division of Public Health and the Division of Long Term Care Residents Protection.

7.5 Separate bathroom facilities shall be provided for the staff.

7.6 Adequate facilities shall be provided for the orderly storage of employee's clothing and personal belongings.

**History**
- *24 DE Reg. 584 (12/01/20)*
- *24 DE Reg. 584 (12/01/20)*
- *24 DE Reg. 584 (12/01/20)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 192 (08/01/11)*
- *16 DE Reg. 637 (12/01/12)*
- *24 DE Reg. 584 (12/01/20)*

##### **16 Del. Admin. Code § 3230-8.0** Services to Residents {#sec-3230-8.0 omnilex-key=us-de-regs-official--title-16--3230-8.0}

8.1 Medication Management

8.1.1 A Rest Residential Home shall establish and adhere to written medication policies and procedures which shall address:

8.1.1.1 Obtaining and refilling medication;

8.1.1.2 Storing and controlling medication;

8.1.1.3 Disposing of medication; and

8.1.1.4 Administration of medication, self-administration of medication and medication management by an adult family member/support person.

8.1.1.5 Provision for a quarterly pharmacy review conducted by a pharmacist which shall include:

8.1.1.5.1 Rest Residential Home with the development and implementation of medication-related policies and procedures;

8.1.1.5.2 Physical inspection of the medication storage areas;

8.1.1.5.3 Review of each resident's medication regimen with written reports noting any identified irregularities or areas of concern.

8.1.2 Each Rest Residential Home shall have a drug reference guide, with a copyright date no older than 2 years, available and accessible for use by employees.

8.1.3 Medication stored by the Rest Residential Home shall be stored and controlled as follows:

8.1.3.1 Medication shall be stored in a locked container, cabinet, or area that is only accessible to authorized personnel;

8.1.3.2 Medication that is not in locked storage shall not be left unattended and shall not be accessible to unauthorized personnel;

8.1.3.3 Medication shall be stored in the original labeled container;

8.1.3.4 A bathroom or laundry room shall not be used for medication storage unless it is kept in a locked container under the circumstances addressed in 8.1.4; and

8.1.3.5 All expired or discontinued medication, including those of deceased residents, shall be disposed of according to the Rest Residential Home's medication policies and procedures.

8.1.4 Residents who self-administer medication shall be provided with a lockable container or cabinet. This requirement does not apply to medications which are kept in the immediate control of the individual resident, such as in a pocket or in a purse. Facility policies must require that medications be secured in a locked container or in a locked room.

8.1.5 A separate medication log must be maintained for each resident documenting administration of medication by staff.

8.1.6 Within 30 days after a resident's admission the Rest Residential Home shall arrange for an on-site review by an RN of the resident's medication regime if he or she self-administers medication. The purpose of the on-site review is to assess the resident's cognitive and physical ability to self-administer medication or the need for staff administration of medication.

8.1.7 The Rest Residential Home shall ensure that the review required by section 8.1.6 is documented in the resident's records, including any recommendations given by the reviewer.

8.1.8 The Rest Residential Home shall arrange for an on-site medication review by a registered nurse, for residents who self-administer or staff administration of medication, to ensure that:

8.1.8.1 Medications are properly labeled, stored and maintained;

8.1.8.2 Each resident receives the medications that have been specifically prescribed in the manner that has been ordered;

8.1.8.3 The desired effect of each medication is achieved, and if not, that the appropriate authorized prescriber is so informed;

8.1.8.4 Any undesired side effects, adverse drug reactions, and medication errors are identified and reported to the appropriate authorized prescriber; and

8.1.8.5 Any unresolved discrepancy of controlled substances shall be reported to the Delaware Office of Narcotics and Dangerous Drugs.

8.2 Food Service

8.2.1 A minimum of three (3) meals shall be available and/or served in each twenty four (24) hour period.

8.2.2 The food served shall be suitably prepared and of sufficient quantity and quality to meet the nutritional needs of the residents.

8.2.3 Special diets served shall be, on the written prescription of the resident's physician.

8.2.4 A copy of the current week's menus regular and therapeutic shall be posted in the kitchen.

8.2.5 A copy of a recent diet manual shall be available for planning therapeutic menus and as a resource for physicians.

8.2.6 Menus showing food actually served each day shall be kept on file for three (3) months.

8.2.7 A Three (3) day supply of food for emergency feeding shall be on the premises.

**History**
- *24 DE Reg. 584 (12/01/20)*
- *24 DE Reg. 584 (12/01/20)*
- *24 DE Reg. 584 (12/01/20)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 192 (08/01/11)*
- *16 DE Reg. 637 (12/01/12)*
- *24 DE Reg. 584 (12/01/20)*

##### **16 Del. Admin. Code § 3230-9.0** Communicable Diseases {#sec-3230-9.0 omnilex-key=us-de-regs-official--title-16--3230-9.0}

9.1 General Requirements

9.1.1 The facility shall follow Division of Public Health regulations for the Control of Communicable and Other Disease Conditions and Centers for Disease Control guidelines for communicable diseases.

9.1.2 The facility shall establish written policies and procedures implementing the Division of Public Health regulations and Centers for Disease Control guidelines for communicable diseases.

9.1.3 The Rest Residential Home shall ensure that the necessary precautions stated in the policies and procedures are followed.

9.1.4 A resident, when suspected or diagnosed as having a communicable disease, shall be placed on the appropriate precautions as recommended for that disease by the Centers for Disease Control. Residents infected or colonized with the same organism may share a room based on current standard of practice.

9.1.5 The admission of a resident with or the occurrence of a disease or condition on the Division of Public Health List of Notifiable Diseases/Conditions within a Rest Residential Home shall be reported to the resident's physician. The facility shall also report such an admission or occurrence to the Division of Public Health's Health Information and Epidemiology office and the Division of Long term Care Residents Protection.

9.2 Specific Requirements for Tuberculosis

9.2.1 A resident diagnosed with active tuberculosis in an infectious stage shall not continue to reside in a Rest Residential Home unless that facility has a room with negative pressure ventilation and staff trained to care for residents requiring respiratory isolation.

9.2.2 A resident of any facility unable to provide care as described above who is diagnosed with active tuberculosis in an infectious stage shall be transferred to an acute care hospital and the facility shall notify the Division of Public Health's Health Information and Epidemiology office immediately.

9.2.3 The facility shall have on file the results of tuberculin testing performed on all newly placed residents.

9.2.4 Minimum requirements for new employee tuberculosis (TB) testing require all employees to have a base line two step tuberculin skin test (TST) or single Interferon Gamma Release Assay (IGRA or TB blood test) such as QuantiFeron. Any required subsequent testing according to risk category shall be in accordance with the recommendations of the Centers for Disease Control and Prevention of the U.S. Department of Health and Human Services. Should the category of risk change, which is determined by the Division of Public Health, the facility shall comply with the recommendations of the Center for Disease Control for the appropriate risk category.

9.2.4.1 No person, including volunteers, found to have active tuberculosis in an infectious stage shall be permitted to give care or service to residents.

9.2.4.2 Any person having a positive skin test but a negative X-ray shall receive an annual evaluation for signs and symptoms of active TB if they cannot provide documentation of completion of treatment for LTBI (latent TB infection).

9.2.4.3 Persons with a prior BCG vaccination are required to be tested as set forth in 9.2.4.

9.3 Specific Requirements for COVID-19

9.3.1 Residents

9.3.1.1 All residents should be tested upon identification of another resident with symptoms consistent with COVID-19, or if facility staff have tested positive for COVID-19.

9.3.1.2 All other resident testing should be consistent with Division of Public Health guidance for the duration of the public health emergency.

9.3.1.3 All testing and test results must be documented in the resident medical record.

9.3.1.4 Facilities must report all resident testing and test results, to the Delaware Division of Public Health.

9.3.2 Staff, vendors and volunteers

9.3.2.1 Prior to their start date, all new staff, vendors and volunteers must be tested in accordance with the Delaware Division of Public Health guidance.

9.3.2.2 All staff, vendors and volunteers who test negative must be retested consistent with Division of Public Health guidance for the duration of the public health emergency.

9.3.2.3 Facilities must report all staff, vendor and volunteer testing and test results, to the Delaware Division of Public Health.

9.3.2.4 Facilities must follow recommendations of the Centers for Disease Control and Prevention of the U.S. Department of Health and Human Services and the Division of Public Health regarding the provision of care or services to residents by staff, vendor or volunteer found to be positive for COVID-19 in an infectious stage.

9.3.2.5 Facilities shall amend their policies and procedures for communicable disease to include:

9.3.2.5.1 Work exclusion and return to work protocols for staff tested positive for COVID-19.

9.3.2.5.2 Staff refusals to participate in COVID-19 testing.

9.3.2.5.3 Staff refusals to authorize release of their testing results to the facility.

9.3.2.5.4 Procedures to obtain staff authorizations for release of laboratory test results to the facility so as to inform infection control and prevention strategies.

9.3.2.5.5 Plans to address staffing shortages and facility demands should a COVID-19 outbreak occur.

**History**
- *24 DE Reg. 584 (12/01/20)*
- *24 DE Reg. 584 (12/01/20)*
- *24 DE Reg. 584 (12/01/20)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 192 (08/01/11)*
- *16 DE Reg. 637 (12/01/12)*
- *24 DE Reg. 584 (12/01/20)*

##### **16 Del. Admin. Code § 3230-10.0** Records and Reports {#sec-3230-10.0 omnilex-key=us-de-regs-official--title-16--3230-10.0}

10.1 There shall be a separate record maintained on each resident. Every resident record shall contain:

10.1.1 Admission record: Including resident's name, birth date, home address prior to entering the facility, identification numbers such as social security, Medicaid, Medicare, etc., date of admission, physician's name, address and phone number, next of kin (relationship, name, address and phone number).

10.1.2 History and physical examination: Prepared by physician within (14) days of the residents admission to the home. If the resident has been admitted to the home immediately after discharge from a hospital, the resident's discharge summary, physical examination and history which were prepared at the hospital, if performed within seven (7) days prior to admission to the home, may be substituted in lieu of the above records. Additionally, a record of an annual medical evaluation performed by a physician must be contained in each resident's file.

10.1.3 A current individual medication inventory shall be maintained.

10.1.4 Accident reports.

10.1.5 Discharge records or notes, including place to which discharged.

10.1.6 Inter-agency transfer form, if the resident was admitted from an acute facility or any other long term care facility.

10.2 Records shall be made available to the resident or the resident's legal representative upon reasonable notice. Otherwise such records shall be held confidential. The consent of the resident or the resident's legal representative shall be obtained before any personal information is released.

10.3 Records shall be retained for five (5) years after discharge or three (3) years after death before being destroyed.

10.4 Incident reports, with adequate documentation, shall be completed for each incident. Adequate documentation shall consist of the name of the resident(s) involved; the date, time and place of the incident; a description of the incident; a list of other parties involved, including witnesses; the nature of any injuries; resident outcome; and follow-up action, including notification of the resident's representative or family, attending physician and licensing or law enforcement authorities, when appropriate.

10.5 All incident reports whether or not required to be reported shall be retained in facility files for three years. Reportable incidents shall be communicated immediately, which shall be within eight hours of the occurrence of the incident, to the Division of Long Term Care Residents Protection. The method of reporting shall be as directed by the Division.

10.6 Incident reports which shall be retained in facility files are as follows:

10.6.1 All reportable incidents as detailed below.

10.6.2 Falls without injury and falls with minor injuries that do not require transfer to an acute care facility or neurological reassessment of the resident.

10.6.3 Errors or omissions in treatment or medication.

10.6.4 Injuries of unknown source.

10.6.5 Lost items which are not subject to financial exploitation.

10.6.6 Skin tears.

10.6.7 Bruises of unknown origin.

10.7 Reportable incidents are as follows:

10.7.1 Abuse as defined in 16 Del.C. §1131.

10.7.1.1 Physical abuse with injury if resident to resident and physical abuse with or without injury if staff to resident or any other person to resident.

10.7.1.2 Any sexual act between staff and a resident and any non-consensual sexual act between residents or between a resident and any other person such as a visitor.

10.7.1.3 Emotional abuse whether staff to resident, resident to resident or any other person to resident.

10.7.2 Neglect, mistreatment or financial exploitation as defined in 16 Del.C. §1131.

10.7.3 Resident elopement under the following circumstances:

10.7.3.1 A resident's whereabouts on or off the premises are unknown to staff and the resident suffers harm.

10.7.3.2 A cognitively impaired resident's whereabouts are unknown to staff and the resident leaves the facility premises.

10.7.3.3 A resident cannot be found inside or outside a facility and the police are summoned.

10.7.4 Significant injuries.

10.7.4.1 Injury from an incident of unknown source in which the initial investigation or evaluation supports the conclusion that the injury is suspicious. Circumstances which may cause an injury to be suspicious are: the extent of the injury, the location of the injury (e.g., the injury is located in an area not generally vulnerable to trauma), the number of injuries observed at one particular point in time, or the incidence of injuries over time.

10.7.4.2 Injury which results in transfer to an acute care facility for treatment or evaluation or which requires periodic neurological reassessment of the resident's clinical status by professional staff for up to 24 hours.

10.7.4.3 Areas of contusions or bruises caused by staff to a dependent resident during ambulation, transport, transfer or bathing.

10.7.4.4 Significant error or omission in medication/treatment, including drug diversion, which causes the resident discomfort, jeopardizes the resident's health and safety or requires periodic monitoring for up to 48 hours.

10.7.4.5 A burn greater than first degree.

10.7.4.6 Any serious unusual and/or life-threatening injury.

10.7.5 Entrapment which causes the resident injury or immobility of body or limb or which requires assistance from another person for the resident to secure release.

10.7.6 Suicide or attempted suicide.

10.7.7 Poisoning.

10.7.8 Fire within a facility.

10.7.9 Utility interruption lasting more than eight hours in one or more major service including electricity, water supply, plumbing, heating or air conditioning, fire alarm, sprinkler system or telephones.

10.7.10 Structural damage or unsafe structural conditions.

10.7.11 Water damage which impacts resident health, safety or comfort.

10.8 The facility shall maintain written policies and procedures, in accordance with 16 Del. C. Chapter 25, regarding health care decisions including advance directives. The facility shall provide written information to all residents explaining such policies and procedures.

**History**
- *24 DE Reg. 584 (12/01/20)*
- *24 DE Reg. 584 (12/01/20)*
- *24 DE Reg. 584 (12/01/20)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 192 (08/01/11)*
- *16 DE Reg. 637 (12/01/12)*
- *24 DE Reg. 584 (12/01/20)*

##### **16 Del. Admin. Code § 3230-11.0** Facility Closure {#sec-3230-11.0 omnilex-key=us-de-regs-official--title-16--3230-11.0}

11.1 In the event of the closing of a facility, the facility shall:

11.1.1 Notify the Division of Long Term Care Residents Protection, the Ombudsman, the Division of Public Health and, if applicable, the Division of Medicaid and Medical Assistance and the Centers for Medicare and Medicaid Services at least 90 days before the planned closure.

11.1.2 Notify each resident directly and his/her attending physician and, if applicable, his/her responsible party by telephone and in writing at least 90 days before the planned closure.

11.1.3 Give the resident or the resident's responsible person an opportunity to designate a preference for relocation to a specific facility or for other arrangements.

11.1.4 Arrange for relocation to other facilities in accordance with the resident's preference, if possible.

11.1.5 Ensure that all resident records, medications, and personal belongings are transferred with the resident and, if to another facility, accompanied by the interagency transfer form.

11.1.6 Provide an accounting of resident trust fund accounts which shall be transferred to each resident's possession or to the facility to which the resident relocates. A record of the accounting of the funds shall be maintained by the closing facility for audit purposes.

11.1.7 Advise any applicant for admission to a facility which has a planned closure date in writing of the planned closure date prior to admission.

**History**
- *24 DE Reg. 584 (12/01/20)*
- *24 DE Reg. 584 (12/01/20)*
- *24 DE Reg. 584 (12/01/20)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 192 (08/01/11)*
- *16 DE Reg. 637 (12/01/12)*
- *24 DE Reg. 584 (12/01/20)*

##### **16 Del. Admin. Code § 3230-12.0** Severability {#sec-3230-12.0 omnilex-key=us-de-regs-official--title-16--3230-12.0}

Should any section, sentence, clause or phrase of these regulations be legally declared unconstitutional or invalid for any reason, the remainder of said regulations shall not be affected thereby.

**History**
- *24 DE Reg. 584 (12/01/20)*
- *24 DE Reg. 584 (12/01/20)*
- *24 DE Reg. 584 (12/01/20)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 192 (08/01/11)*
- *16 DE Reg. 637 (12/01/12)*
- *24 DE Reg. 584 (12/01/20)*

#### **3301** Group Home Facilities for Persons with AIDS

##### **16 Del. Admin. Code § 3301** Group Home Facilities for Persons with AIDS {#sec-3301 omnilex-key=us-de-regs-official--title-16--3301}

These regulations are promulgated in accordance with 16 Del.C. Ch. 11. All facilities must comply with applicable local, state and federal laws and regulations.

**History**
- *5 DE Reg. 1079 (11/01/01)*
- *25 DE Reg. 762 (02/01/22)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *14 DE Reg. 1360 (06/01/11)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *15 DE Reg. 192 (08/01/11)*
- *5 DE Reg. 1079 (11/01/01)*
- *25 DE Reg. 762 (02/01/22)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *25 DE Reg. 762 (02/01/22)*

##### **16 Del. Admin. Code § 3301-1.0** Definition {#sec-3301-1.0 omnilex-key=us-de-regs-official--title-16--3301-1.0}

The following regulations are designed specifically for Group Homes for sixteen (16) or less persons with AIDS and establish the minimal acceptable level of living and programmatic conditions in such homes. Only those residents shall be admitted with an established diagnosis and disease progression such that the resident requires a routine and frequent combination of physician, professional nursing and supportive services. Provisions shall be made for the transfer and/or discharge of residents When acute care (hospital) services am required or requested.

**History**
- *5 DE Reg. 1079 (11/01/01)*
- *25 DE Reg. 762 (02/01/22)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *14 DE Reg. 1360 (06/01/11)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *15 DE Reg. 192 (08/01/11)*
- *5 DE Reg. 1079 (11/01/01)*
- *25 DE Reg. 762 (02/01/22)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *25 DE Reg. 762 (02/01/22)*

##### **16 Del. Admin. Code § 3301-2.0** Glossary of Terms {#sec-3301-2.0 omnilex-key=us-de-regs-official--title-16--3301-2.0}

“Activities of Daily Living” - Normal daily activities including but not limited to ambulating, transferring, range of motion, grooming, bathing, dressing, eating and toileting.

“Certified Nursing Assistant” - An individual certified in accordance with 16 Del.C., Ch. 30A who provides care that does not require the judgment and skills of a licensed nurse.

“Continuous” - Available at all times without cessation, break or interruption.

“Department” - Department of Health and Social Services

“Dietitian” - A person currently registered by the Commission on Dietetic Registration of the American Dietetic Association and/or a Certified Dietitian/Nutritionist in the State of Delaware.

“Direction” - Authoritative policy or procedural guidance for the accomplishment of a function or activity.

“Division “- Division of Health Care Quality.

“Facilities” - The site, physical structure and equipment necessary to provide the required service.

“Group Home Administrator” - The individual responsible for the operation of the group home.

“Incident” - An occurrence or event, a record of which must be maintained in facility files, that results or might result in harm to a resident. Incident includes alleged abuse, neglect, mistreatment and financial exploitation; incidents of unknown source which might be attributable to abuse, neglect or mistreatment; all deaths; falls; and errors or omissions in medication/treatment. (Also see Reportable Incident)

“Licensed Practical Nurse” - A nurse who is licensed to practice as a practical nurse in the State of Delaware or whose license is recognized to practice in Delaware.

“Licensee” - The person or organization to whom the group home for persons with AIDS license is granted. The licensee has full legal authority and responsibility for the governance and operation of the group home.

“Medical and Nursing Services” - The services pertaining to medical care and performed at the direction of a physician on behalf of residents by physicians, nurses, or any other professional or technical personnel such as an advanced nurse practitioner or physician's assistant and which may include the curative, restorative, preventive and palliative aspects of nursing care.

“Notifiable Diseases” - A communicable disease or condition of public health significance required to be reported to the Division of Public Health in accordance with the Delaware Department of Health and Social Services Regulations for the Control of Communicable and other Disease Conditions.

“Nursing Service Personnel” - Those licensed or unlicensed persons giving direct services to the residents, pertaining to the curative, restorative, preventive or palliative aspects of nursing care and who are supervised by either a registered professional nurse or a licensed practical nurse.

“Personal Care Services” - Those health related services that include general supervision of and direct assistance to, individuals in their activities of daily living.

“Physician” - A physician licensed to practice in the State of Delaware.

“Registered Nurse” - A nurse who is a graduate of an approved school of professional nursing and who is licensed to practice in the State of Delaware or whose license is recognized to practice in Delaware.

“Reportable Incident” - An occurrence or event which must be reported at once to the Division and for which there is reasonable cause to believe that a resident has been abused, neglected, mistreated or subjected to financial exploitation. Reportable incident also includes an incident of unknown source which might be attributable to abuse, neglect or mistreatment; all deaths; falls with injuries; and significant errors or omissions in medication/treatment which cause the resident discomfort or jeopardize the resident's health and safety. (Also see Incident)

“Resident Beds” - Accommodations with supportive services (such as: food, laundry, housekeeping) for persons who generally stay in excess of twenty-four (24) hours.

“Supervision” - That degree of oversight and inspection of licensed and unlicensed personnel necessary to ensure the safety, comfort and well-being of residents.

**History**
- *5 DE Reg. 1079 (11/01/01)*
- *25 DE Reg. 762 (02/01/22)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *14 DE Reg. 1360 (06/01/11)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *15 DE Reg. 192 (08/01/11)*
- *5 DE Reg. 1079 (11/01/01)*
- *25 DE Reg. 762 (02/01/22)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *25 DE Reg. 762 (02/01/22)*

##### **16 Del. Admin. Code § 3301-3.0** Licensing Requirements and Procedures {#sec-3301-3.0 omnilex-key=us-de-regs-official--title-16--3301-3.0}

3.1 When a facility is classified under this law or regulation and plans to construct, extensively remodel or convert any buildings, one (1) copy of property prepared plans and specifications for the entire facility are to be submitted to the Division. An approval in writing is to be obtained before such work is begun. After the work is completed, in accordance with the plans and specifications, a new license to operate will be issued.

3.2 Separate licenses are required for facilities, maintained in separate locations, even though operated under the same management. A separate license is not required for separate buildings maintained by the same management on the same grounds. Under conditions of assignment or transfer of ownership, a new license will be issued.

3.3 Inspections

Every group home for persons with AIDS for which a license has been issued under this chapter shall be periodically inspected by a representative of the Division of Public Health.

3.3.1 Issuance of Licenses

Licenses shall be issued in the following categories:

3.3.1.1 Annual License. An annual license (12 months) may be renewed yearly if the holder is in full compliance with the provisions of 16 Del.C. Ch. 11 and the rules and regulations of the Department of Health and Social Services.

3.3.1.2 Provisional License. A provisional license shall be granted for a term of ninety (90) days only, and shall be granted to a group home during its first 90 days of operation. A provisional license may also be granted to a group home, which although not in full compliance, is nevertheless demonstrating evidence of improvement.

3.4 The Division may adopt, amend, or repeal regulations governing the operation of facilities defined under 16 Del.C. Ch. 11, Subchapter I., Licensing By The State, and shall establish reasonable standards of equipment, capacity, sanitation, and any other conditions which might influence the health or welfare of the residents of such institutions.

**History**
- *5 DE Reg. 1079 (11/01/01)*
- *25 DE Reg. 762 (02/01/22)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *14 DE Reg. 1360 (06/01/11)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *15 DE Reg. 192 (08/01/11)*
- *5 DE Reg. 1079 (11/01/01)*
- *25 DE Reg. 762 (02/01/22)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *25 DE Reg. 762 (02/01/22)*

##### **16 Del. Admin. Code § 3301-4.0** General Requirements {#sec-3301-4.0 omnilex-key=us-de-regs-official--title-16--3301-4.0}

4.1 All required records maintained by the group home for persons with AIDS shall be open to inspection by the authorized representatives of the Division.

4.2 The term "Group Home" shall not be used as part of the name of any facility in this State, unless it has been so classified by the Department of Health and Social Services.

4.3 No rules shall be adopted by the licensee or administrator which are in conflict with these regulations.

4.4 The Division shall be notified, in writing, of any changes in the Administrator.

4.5 The group home shall establish written polices regarding the rights and responsibilities of residents, and these policies and procedures are to be made available to sponsoring agency(ies), and authorized representatives of the Division.

4.6 Each facility shall make known, in writing, the refund and prepayment policy at the time of admission, and in the case of thirdparty payment, an exact statement of responsibility in the event of retroactive denial.

4.7 The group home shall provide safe storage for resident's valuables.

4.8 The group home provider shall assure emergency transportation and care through use of appropriate transfer agreements with local medical facilities

4.9 All residents shall be afforded all protections and privileges contained in the Delaware Patients Bill of Rights.

4.10 The facility shall cooperate fully with the state protection and advocacy agency, as defined in 16 Del.C. §1102(7), in fulfilling functions authorized by Title 16, Chapter 11.

**History**
- *5 DE Reg. 1079 (11/01/01)*
- *25 DE Reg. 762 (02/01/22)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *14 DE Reg. 1360 (06/01/11)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *15 DE Reg. 192 (08/01/11)*
- *5 DE Reg. 1079 (11/01/01)*
- *25 DE Reg. 762 (02/01/22)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *25 DE Reg. 762 (02/01/22)*

##### **16 Del. Admin. Code § 3301-5.0** Plant, Equipment and Physical Environment {#sec-3301-5.0 omnilex-key=us-de-regs-official--title-16--3301-5.0}

5.1 Site Provisions:

Each group home for persons with AIDS shall be located on a site which is considered suitable by the Division of Public Health. The site must be safe easily drained, suitable for the disposal of sewage, and for the furnishing of a potable water supply.

5.2 Water Supply and Sewage Disposal:

5.2.1 The water supply and the sewage, disposal system shall be approved by the Division of Public Health and the Department of Natural Resources and Environmental Control respectively.

5.2.2 The water system shall be designed to supply adequate hot and cold water, under pressure, at all times.

5.2.3 Hot water at shower, bathing and hand washing facilities shall not exceed 110°F (43°C).

5.3 Building:

5.3.1 The building shall be so constructed and maintained to prevent the entrance or existence of rodents and insects at all times. An exterior openings shall be effectively screened during the fly season. Screen doors shall open outward. All screening shall have at least sixteen (16) mesh per inch.

5.3.2 The root exterior walls, doors, sky lights and windows shall be weather tight and watertight and shall be kept in sound condition and good repair.

5.3.3 The exterior of the site shall be free from hazards and also from the accumulation of litter.

5.3.4 Floor and wall surfaces of bathrooms, kitchens, and soiled utility rooms shall be constructed and maintained to be impervious to water and to permit the floor and walls to be easily kept in a clean condition.

5.3.5 Basements shall be of such construction that they can be maintained in a dry and sanitary condition.

5.3.6 Main entrance areas shall open into general or group function areas, usually living rooms.

5.3.7 The group home facility must be handicapped accessible. The entrance and circulation areas shall meet appropriate American National Standards Institute ('A.N.S.I.') standards and all other State and Federal standards.

5.3.8 One of the main points of entry for the facility shall provide entry closet capacity for outdoor and foul weather clothing.

5.3.9 Traffic to and from any room shall not be through a bedroom bathroom, utility room or kitchen except where a utility room, toilet room or bathroom opens directly off the room it serves.

5.4 Plumbing:

The plumbing shall meet the requirements of all municipal or county codes. Where there is no local law, the provisions of the Division of Public Health Sanitary Plumbing Code shall prevail.

5.5 Heating Ventilation and Air Conditioning:

5.5.1 The heating equipment for all living and sleeping quarters shall be adequate, safe, protected, and easily controlled. It shag be capable of maintaining the temperature in each room used by residents at a minimum of 72°F (21°C). Portable heating devices shall not be used.

5.5.2 The group home must be adequately ventilated. Air conditioning equipment must be adequate and capable of maintaining the temperature in each room used by residents between 72°F 82°F.

5.6 Lighting:

Each room must be suitably lighted at all times for maximum safety, comfort sanitation and efficiency of operation. A minimum of 30 foot candles of fight shall be provided for all working and reading surfaces, and a minimum of 10 foot candles of fight on all other areas. This includes hallways, stairways, storerooms and bathrooms.

5.7 Safety Equipment:

5.7.1 To prevent slipping, staircases shall have stair treads and sturdy handrails.

5.7.2 Floor surfaces, especially in heavy traffic areas shall be durable, yet non abrasive and slip-resistant. Area rugs on hand finished floors shall have a non skid backing. Carpeting shall be maintained in a clean and slip-resistant condition.

5.7.3 All doors for areas used by residents shall be capable of being opened from both sides.

5.8 Bedrooms:

5.8.1 Each room shall be an outside room with at least one (1) window opening directly to the outside. The windowsill shall be at least three (3) feet above the floor and above grade. Windows shall be constructed to allow a maximum of sunlight and air, to eliminate drafts, and be easy to open and close. Window area shall be no less than the equivalent of one-tenth (1/10) of the floor space.

5.8.2 Bedrooms for one (1) person shall be at least 100 square feet in size; and bedrooms for more than one (1) person shall provide at least 80 square feet of floor space per person and be adequately spaced for resident care. (Minimum room areas are exclusively of toilet rooms, closets lockers, wardrobes, alcoves or vestibules). The ceiling shall not be less than seven (7) feet from the floor.

5.8.3 Each bedroom is to have walls that go to the ceiling and a door that can be closed.

5.8.4 Adequate electrical outlets shall be conveniently located in each room and each room shall have general lighting and night lighting. A reading light shall be provided for each resident. At least one light fixture shall be switched at the entrance to each bedroom.

5.8.5 Facilities shall ensure adequate privacy and separation of sexes in sleeping arrangements except in cases of husband or wife or other long term consensual partnership arrangements.

5.8.6 If bedroom doors of residents are locked by residents for privacy reasons, all persons on duty must carry a master key for these locks.

5.8.7 Bedrooms shall accommodate no more than two residents per room.

5.8.8 Bedrooms shall contain a separate bed of proper size and height for each resident.

5.8.9 Each resident shall be provided with at least one chair, chest-of-drawers, closet space with a clothes rack and shelves, and a mirror.

5.8.10 Bedroom windows shall have window treatment(s) that close for privacy.

5.8.11 Bedroom doors shall open directly into corridors or hallways.

5.9 Bathrooms and Hand Washing Facilities:

5.9.1 At least one (1) window or mechanical ventilation to the outside shall be provided.

5.9.2 Bathroom design shall bee handicapped accessible and meet appropriate American National Standards Institute (ANSI) Standards.

5.9.3 Toilets, showers, bathtubs and wash basins shall provide accessible traffic patterns for all resident rooms.

5.9.4 Toilets, bathing and toileting appliances shall be equipped for use by multiple handicapped residents.

5.9.5 There shall be at least one toilet of appropriate size for every four clients:

5.9.5.1 Each toilet shall be equipped with a toilet seat and toilet tissue.

5.9.5.2 Separate toilet facilities with hand washing must be provided for staff.

5.9.6 There shall be at least one hand washing sink for every four clients. Hand washing facilities shall be readily accessible to residents and staff. Hand washing facilities shall be provided in each resident room or located in an adjoining toilet room available at a reasonable distance from the resident room.

5.9.7 There shall be at least one tub or shower equipped with grip bars and slip resistant surfaces for every four residents. At least one shower must be handicapped accessible without curbs.

5.9.8 Wash basins shall be available in or immediately adjacent to bathrooms and toilet rooms.

5.9.9 Bathroom areas shall be equipped with mirrors for personal grooming. Mirrors shall be installed in such a way to minimize the danger or breakage.

5.10 Day Room and Dining Area:

5.10.1 There shall be at least 30 square feet per client within the house, not including client bedrooms, for recreation, dining and program activities.

5.10.2 When a multi-purpose room is used for dining and recreation, it shall have sufficient space to accommodate all activities and to prevent interference among activities.

5.10.3 Basement space may be used for recreation activities if there are a minimum of two fire exits.

5.10.4 Appropriate leisure and mealtime furniture, as well as comfortable seating shall be provided for each resident.

5.11 Kitchen and Pantry/Storage Areas:

5.11.1 The kitchen shall provide sufficient space to carry out proper food preparation and dishwashing operations and shall have:

5.11.1.1 Walls, floors and counters with coverings which are easily cleaned and impervious to water. Food contact surfaces, utensils and equipment shall be of approved material, cleanable and shall be kept in good repair.

5.11.1.2 At least one (1) refrigerator in proper working order, capable of maintaining foods at 41°F, or below, as determined in the warmest part of the refrigerator, and one (1) freezing unit, in proper working order capable of maintaining frozen foods in a continuous frozen state.

5.11.1.3 At least one (1) four burner range and one (1) oven which are in proper working order.

5.11.1.4 A dishwasher shall be provided to effectively remove food sod and soaps or detergents from dishes, utensils and equipment used in food storage, preparation and service. The dishwasher must be supplied with hot water of 165°F. If a dishwasher is not used, dishes, equipment, and utensils shall first be washed, next rinsed, and then sanitized according to the following:

5.11.1.4.1 Immersion for at least one-half (1/2) minute in clean, hot water of a temperature of at least 1700 F;

5.11.1.4.2 Immersion for at least one (1) minute in a clean solution containing at least fifty (50) parts per million of available chlorine as a hypochlorite (household bleach or the equivalent) and having a temperature of at least 750F.

5.11.2 Cleaned dishes, utensils and equipment shall be stored in a clean dry area protected from contamination by splash, dust or other means.

5.12 Sanitation and Housekeeping:

5.12.1 All rooms and every part of the building shall be kept clean, orderly and free of offensive odors.

5.12.2 Policy manuals shall be prepared and followed which outline maintenance and cleaning procedures safe storage of cleaning materials and pesticides and other potentially toxic materials, and safe storage and handling of linen and other matters which pertain to the comfort and safety of the residents.

5.12.3 There shall be a minimum of three sets of towels, washcloths, sheets and pillowcases for each resident which shall be changed at least weekly or whenever soiled.

5.12.4 There shall be separate areas for storage of

5.12.4.1 Food items.

5.12.4.2 Cleaning agents, disinfectants and polishes.

5.12.4.3 Poisons, chemicals and pesticides.

5.12.4.4 Eating, serving and cooking utensils.

5.12.5 A ventilated janitors closet must be provided containing a service sink for storage and use of housekeeping items.

5.12.6 Laundry processing must limit the handling of laundry and must utilize universal precautions in the handling of all soiled laundry.

5.12.6.1 On-site laundry processing area must include:

5.12.6.1.1 One room with areas for receiving, sorting, and washing of soiled linen. Washers must be supplied with hot water of 160°F. Room must be property ventilated with air flow under negative pressure in relation to adjacent areas.

5.12.6.1.2 One room for drying and folding of clean linen. Room must have hand washing immediately accessible and be properly ventilated with air flow under positive pressure in relation to adjacent areas.

5.12.6.2 Off-site laundry processing must comply with the following:

5.12.6.2.1 A contract with a commercial laundry must be obtained for the proper processing of soiled linen.

5.12.6.2.2 A property ventilated soiled linen holding room (ventilated directly outside, with an air flow under negative pressure) or a designated area in the soiled utility room shall be provided for the storage of soiled linen.

5.12.6.2.3 A clean linen storage closet sufficient for the storage of clean linen must be provided.

5.12.7 Soiled utility room for storage of regulated infectious waste, sharps and disposal of body fluids must be provided and must contain a work counter, hand washing facilities, clinical sink or other bed pan cleaning device. This room must be property ventilated directly outside with air flow under negative pressure in relation to adjacent area (10 total air exchanges per hour).

5.13 Nursing Equipment and Supplies:

5.13.1 There shall be sufficient equipment and supplies for nursing care to meet the needs of each resident. It shall be the responsibility of the administrator to obtain specific items required for individual cases.

5.13.2 Over the bed tables shall be provided for residents who may not be able to be served a meal in the dining room.

5.13.3 There shall be sufficient space and facilities available for the proper cleansing, disinfection, sterilization (if done on premises) and storage of nursing supplies and equipment.

5.13.4 A call system shall be provided for each resident. This system shall be accessible to each bed, each toilet room bathroom and shower room used by residents.

5.13.5 The facility shall maintain a scale on the premises which can accommodate the physical condition of each resident.

5.13.6 The group home provider shall provide bag and mask for assisted ventilation.

**History**
- *5 DE Reg. 1079 (11/01/01)*
- *25 DE Reg. 762 (02/01/22)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *14 DE Reg. 1360 (06/01/11)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *15 DE Reg. 192 (08/01/11)*
- *5 DE Reg. 1079 (11/01/01)*
- *25 DE Reg. 762 (02/01/22)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *25 DE Reg. 762 (02/01/22)*

##### **16 Del. Admin. Code § 3301-6.0** Fire Safety {#sec-3301-6.0 omnilex-key=us-de-regs-official--title-16--3301-6.0}

6.1 Fire safety in group homes shall comply with the adopted rules and regulations of the State Fire Prevention Commission. Enforcement of Fire Regulations is the responsibility of the State Fire Prevention Commission. All applications for a license or renewal of a license must include, with the application, a letter certifying compliance by the Fire Marshal having jurisdiction. Notification of noncompliance with the Rules and Regulations of the State Fire Prevention commission shall be grounds for revocation of a license.

6.2 There must be sufficient staff (a minimum of two) awake and on duty at all times including the night shift, to evacuate all residents in case of fire. More than two staff shall be on duty at all times if the Fire Marshal determines that more staff is required to evacuate residents timely in case of fire.

6.3 Residents and all staff on each shift shall be trained in executing the evacuation plan.

6.4 Evacuation drills must be held at least quarterly on each shift for all staff and residents.

**History**
- *5 DE Reg. 1079 (11/01/01)*
- *25 DE Reg. 762 (02/01/22)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *14 DE Reg. 1360 (06/01/11)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *15 DE Reg. 192 (08/01/11)*
- *5 DE Reg. 1079 (11/01/01)*
- *25 DE Reg. 762 (02/01/22)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *25 DE Reg. 762 (02/01/22)*

##### **16 Del. Admin. Code § 3301-7.0** Personnel/Administrative {#sec-3301-7.0 omnilex-key=us-de-regs-official--title-16--3301-7.0}

7.1 There must be a licensee of the facility. The licensee must:

7.1.1 Exercise general policy, budget, and operating direction over the facility;

7.1.2 Appoint the administrator of the facility who shall have:

7.1.2.1 An associates degree or higher from an accredited college or university plus three (3) years experience in a health or human services field; or

7.1.2.2 A bachelor's degree or higher in a health, business, or related field and a minimum of one year's work experience in a health or human service field.

7.1.2.3 Insure all operations of the group home facility are conducted in accordance with these regulations and applicable Federal, state and local laws and requirements.

7.2 The licensee and the administrator shall be responsible for complying with the regulations herein contained. In the absence of the administrator, a qualified substitute shall be authorized, in writing, to be in charge.

7.3 The administrator must be on duty and on site in the home a minimum of four (4) hours a day, five (5) days a week.

7.4 In addition to the staff engaged in the direct care and treatment of residents, there must be sufficient personnel to provide basic services such as: food service, laundry, housekeeping and plant maintenance. Nursing service personnel shall not be engaged in food service, laundry, housekeeping and plant maintenance.

7.5 All personnel shall submit to and pass a criminal background check and drug testing in accordance with 16 Del.C. Ch. 11, Subchapter IV., Criminal Background Checks and Mandatory Drug Testing.

7.6 No employee shall be less than 18 years of age and no person shall be employed who has been convicted of a disqualifying crime as set forth in the Criminal Background Check regulations of the Division of Long Term Care Residents Protection.

7.7 The facility shall have written personnel policies and procedures that adequately support sound resident care. Personnel records of each employee shall be kept current and available upon request by the Division representatives and shall contain sufficient information to support placement in the positions to which assigned.

7.8 Minimum requirements for employee physical examinations include:

7.8.1 The facility shall have on file results of tuberculin tests performed annually for all employees, including volunteers who are involved in the care of residents. The tuberculin test to be used is the Mantoux test containing 5 TU-PPD stabilized with Tween, injected intradermally, using a needle and syringe, usually on the volar surface of the forearm. Persons found to have a significant reaction (defined as 10 mm of induration or greater) to tests shall be reported to the Division of Public Health and managed according to recommended medical practice. A tuberculin test as specified, done within the twelve months prior to employment or a chest x-ray showing no evidence of active tuberculosis shall satisfy this requirement for asymptomatic individuals. A report of this skin test shall be kept on file.

7.8.2 Employees who do not have a significant reaction to the initial tuberculin test (those individuals who have less than 10 mm induration) should be retested within 7 - 21 days to identify those who demonstrate delayed reactions. Tests done within one year of a previous test need not be repeated in 7 -21 days.

7.8.3 No person, including volunteers, found to have active tuberculosis in an infectious stage shall be permitted to give care and service to residents.

7.9 Each applicant of a group home must have a medical evaluation for tuberculosis before being admitted to a group home. Any resident found to have active tuberculosis in an infectious stage may not be admitted or continue to reside in a group home.

7.10 The licensee shall approve written policies and procedures pertaining to the services the group home provides. Such policies and procedures should reflect the philosophy and objectives of the home to provide on a continuing basis good medical, nursing and psychosocial care for all persons admitted to the home who require such care, Such policies and procedures shall reflect the requirements of Section 62.7 and include:

7.10.1 Admission, transfer and discharge policies

7.10.2 Categories of residents accepted or not accepted

7.10.3 Physician services

7.10.4 Nursing services

7.10.5 Food and nutrition services including kitchen sanitation, food handling and storage

7.10.6 Rehabilitative services

7.10.7 Pharmaceutical services

7.10.8 Diagnostic services

7.10.9 Housekeeping services

7.10.10 A written policy and procedure denoting care of residents

7.10.10.1 In an emergency

7.10.10.2 During a communicable disease episode

7.10.10.3 In case of critical illness or mental disturbance

7.10.11 Dental services

7.10.12 Social services

7.10.13 Resident activities, recreational, social, religious

7.10.14 Clinical records

7.10.15 Fire and safety policies

7.10.16 Advance directives to include:

7.10.16.1 On admission, inform residents in writing of their right 1) to accept or refuse treatment, 2) to give written instructions concerning their care and 3) to appoint an agent or proxy to make health cue decisions.

7.10.16.2 Documenting in medical records whether or not residents have executed advance directives.

7.10.16.3 Ensuring compliance with requirements of state law on advance directives.

7.10.16.4 Providing education for staff on issues concerning advance directives.

7.10.17 Infection control.

7.11 A group home that provides direct healthcare services to persons diagnosed as having Alzheimer’s disease or other forms of dementia shall provide dementia specific training each year to those healthcare providers who must participate in continuing education programs. The mandatory training must include: communicating with persons diagnosed as having Alzheimer’s disease or other forms of dementia; the psychological, social, and physical needs of those persons; and safety measures which need to be taken with those persons. This paragraph shall not apply to persons certified to practice medicine under the Medical Practice Act, Chapter 17 of Title 24 of the Delaware Code.

**History**
- *5 DE Reg. 1079 (11/01/01)*
- *25 DE Reg. 762 (02/01/22)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *14 DE Reg. 1360 (06/01/11)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *15 DE Reg. 192 (08/01/11)*
- *5 DE Reg. 1079 (11/01/01)*
- *25 DE Reg. 762 (02/01/22)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *25 DE Reg. 762 (02/01/22)*

##### **16 Del. Admin. Code § 3301-8.0** Services to Residents {#sec-3301-8.0 omnilex-key=us-de-regs-official--title-16--3301-8.0}

8.1 Group Home Services:

8.1.1 The group home, shall provide to all residents the care deemed necessary for their comfort, safety nutritional requirements and general well being

8.1.2 The group home shall have in effect a written transfer agreement with one (1) or more hospitals, which provides the basis for an effective working arrangement under which inpatient hospital care, or other hospital services, are available promptly to the facilities residents, when needed.

8.1.3 The group home shall have a written contract agreement for promptly obtaining required laboratory, x-ray and other diagnostic services. These services may be obtained from other facilities that meet applicable local, state and Federal laws and regulations.

8.1.4 The group home shall have arrangements for the provision of all other services and supplies to meet the health and psychosocial needs of each resident. Such arrangements may be other met by appropriately licensed facility staff or by contractual agreements with organizations or individuals licensed as applicable by the State of Delaware.

8.1.5 The group home shall immediately inform the attending or emergency physician, registered nurse and if known, notify the resident's legal representative, interested family member, or other parties as designated by the resident when there is:

8.1.5.1 an accident involving the resident.

8.1.5.2 a significant change in the resident's physical, mental, or psychosocial status (i.e., a deterioration in health, mental or psychosocial status in either life threatening conditions or clinical complications);

8.1.5.3 a need to alter treatment significantly (i.e., a need to discontinue an existing form of treatment due to adverse consequences, or to commence a new form of treatment).

8.2 Medical and Nursing Services:

8.2.1 The group home shall provide for medical and nursing services either directly or through contract arrangements with organizations or individuals licensed as applicable by the State of Delaware.

8.2.2 All persons admitted to a group home shall be under the care of a licensed physician and shall be seen by their attending physician at least every 30 days, unless Justified otherwise and documented by the attending physician.

8.2.3 All group homes shall arrange for one (1) or more licensed physicians to be called in an emergency. Names and phone numbers of these physicians shall be posted in a conspicuous location.

8.2.4 All orders for medications, treatments, diets, and diagnostic services shall be in writing and signed by the attending physician. Telephone orders shall be countersigned by the physician within fourteen (14) working days.

8.2.5 All statements of medical treatment goals and treatment plans shall be reviewed and updated as needed by the attending physician, to insure continuing appropriateness of the goals, consistency of management methods with the goals and the achievement of progress towards the goals.

8.2.6 A progress note shall be written and signed by the physician if he/she makes an on-site visit.

8.2.7 The nursing services provided either directly or through contractual arrangements include:

8.2.7.1 An assessment of the resident upon admission, by a registered nurse and development of written resident care plans in conjunction with the physician and other professionals as needed.

8.2.7.1.1 Individual written resident care plans to meet the resident's needs shall be developed within seven (7) days of admission and reviewed at least every 62 days by registered nurses and other professional disciplines, as required.

8.2.7.1.2 In the event that there is a significant change in the resident's medical or psychosocial condition the care plan shall be modified to meet the needs of the resident.

8.2.7.2 The coordination and monitoring of resident care and services with the physician and other health professionals by a registered nurse who visits the group home at least weekly.

8.2.7.3 A supervisory visit to the group home at least every two weeks by a registered nurse who conducts an assessment of the care provided by the certified nurse assistants.

8.2.7.4 The administration of treatments and medications by licensed nurses in accordance with the Nurse Practice Act.

8.2.8 There must be a sufficient number of trained personnel to provide for direct care of residents with a minimum of two (2) nursing service personnel on duty at all times. However, should all residents be ambulatory and capable of self-evacuation, only one nursing service personnel shall be required on duty at all times. Each nurse assistant employed by the group home shall have met the training and testing requirements for certification and be registered in good standing on the Delaware Nurse Aide Registry.

8.3 Infection Control:

8.3.1 Prevention and Control Services

The facility shall establish and implement an infection prevention and control program. The Administrator shall ensure the development and implementation of the program.

The facility shall establish and implement written policies and procedures regarding infection prevention and control including, but not limited to:

8.3.1.1 Universal Precautions as established by the Centers for Disease Control and Prevention (CDC).

8.3.1.2 A system for investigating, reporting, and evaluating the occurrence of all infections, diseases, or conditions which are reportable to the Division of Public Health that may be related to staff activities and procedures of the facility;

8.3.1.3 Notifiable diseases shall be reported to the County Public Health Administrator;

8.3.1.4 Care of residents with communicable diseases;

8.3.1.5 Policies and procedures for exclusion from work and authorization to return to work for personnel with communicable diseases;

8.3.1.6 Surveillance techniques to minimize sources and transmission of infection;

8.3.1.7 Disinfection, cleaning and care practices and techniques used in the facility including, but not limited to the following:

8.3.1.7.1 Care of utensils, instruments, solutions, dressings, articles and surfaces;

8.3.1.7.2 Selection, storage, use and disposition of disposable and non-disposable resident care item;

8.3.1.7.3 Methods to ensure that sterilized materials are packaged and labeled to maintain sterility and to permit identification of expiration dates;

8.3.1.7.4 Procedures for care of equipment and other devices that provide a portal of entry for pathogenic micro-organisms;

8.3.1.7.5 Techniques to be used during each resident contact including hand washing before and after caring for a resident;

8.3.1.7.6 Criteria and procedures for isolation of residents.

8.3.1.7.7 All personnel shall receive orientation at the time of employment and annual in-service education regarding the infection prevention and control program

8.3.2 Infectious Disease and Waste Removal

The facility shall establish and implement policies and procedures for the collection, storage, handling and disposition of all pathological and infectious wastes within the facility, and for the collection, storage, handling and disposition of all pathological and infectious wastes to be removed from the facility, including, but not limited to the following:

8.3.2.1 Needles and syringes and other solid, sharp, or rigid items shall be placed in a puncture resistant container and incinerated or compacted prior to disposal.

8.3.2.2 Needles and syringes shall be destroyed or disposed of in a safe and proper manner by an infectious waste hauler approved by the Department of Natural Resources and Environmental Control.

8.3.2.3 Non-rigid items, such as blood tubing and disposable equipment and supplies, shall be incinerated or placed in double, heavy duty, impervious plastic bags and disposed of by an infectious waste hauler approved by the Department of Natural Resources and Environmental Control.

8.3.2.4 Fecal matter and liquid waste, such as blood and blood products, shall be flushed into, the sewage system or otherwise disposed of in accordance with federal, state and local standards or regulations.

8.3.2.5 All pathology specimens, tissue and waste, including gross and microscopic tissue removed surgically or by any other procedure and products of conception must be disposed of in compliance with OSHA (Occupational Safety and Health Administration), EPA (Environmental Protection Agency), DNREC (Department of Natural Resources and Environmental Control) and other state and local standards covering the treatment of medical waste.

8.3.2.6 Collection, storage, handling and disposition procedures of all pathological and infectious wastes within the facility shall meet the of all state and federal codes.

8.3.3 Specific Requirements for COVID-19

8.3.3.1 Before their start date, all new staff, vendors and volunteers must be tested for COVID-19 in accordance with Division of Public Health guidance.

8.3.3.2 All staff, vendors and volunteers must be tested for COVID-19 in a manner consistent with Division of Public Health guidance.

8.3.3.3 The facility must follow recommendations of the Centers for Disease Control and Prevention and the Division of Public Health regarding the provision of care or services to residents by staff, vendor or volunteer found to be positive for COVID-19 in an infectious stage.

8.3.4 The facility shall amend their policies and procedures to include:

8.3.4.1 Work exclusion and return to work protocols for staff tested positive for COVID-19;

8.3.4.2 Staff refusals to participate in COVID-19 testing;

8.3.4.3 Staff refusals to authorize release of testing results or vaccination status to the facility;

8.3.4.4 Procedures to obtain staff authorizations for release of laboratory test results to the facility to inform infection control and prevention strategies; and

8.3.4.5 Plans to address staffing shortages and facility demands should a COVID-19 outbreak occur.

8.4 Medications:

8.4.1 All medication administered to residents shall be ordered in writing, dated and signed by the attending physician. All prescription medications shall be properly labeled in accordance with 24 Del.C. Ch. 25 and the regulations of the Delaware Board of Pharmacy. The label shall contain the following information:

8.4.1.1 The prescription number;

8.4.1.2 The date such drugs were originally dispensed to the resident;

8.4.1.3 The resident's full name;

8.4.1.4 The brand or established name and strength of the drug to the extent that it can be measured;

8.4.1.5 The physician's directions as found on the prescription;

8.4.1.6 The physician's name;

8.4.1.7 The name and address of the dispensing pharmacy or physician.

8.4.2 Medications may be self-administered or administered in accordance with the Nurse Practice Act. Those residents who, upon admission, are incapable of self-administration or who become incapable of self-administration will have the medications administered according to the Nurse Practice Act.

8.4.3 The group home provider licensee shall maintain a record of all medication provided to a resident indicating time of day, type of medication, dose, route of self-administration/administration, by whom given and any reactions noted.

8.4.4 Medication Storage

8.4.4.1 Provisions for the locked storage of medications shall be provided. Medication storage area shall contain a work counter, refrigerator and hand sink. The key to the medication storage must be in the possession of or accessible only to personnel responsible for the distribution for self-administration/administration of medications. If secure storage of medications is provided in resident rooms for those residents capable of self-administration the key to the medication storage must be in the possession of the resident.

8.4.4.1.1 No stock supplies of drugs except those approved for the emergency drug kit and those commonly available without prescription (non-legend drugs), e.g., antacids, aspirin, laxatives, shall be kept in the facility.

8.4.4.1.2 Prescription medication not requiring refrigeration shall be kept in the original container stored in a locked cabinet or drawer, and clearly labeled for the specific resident. These medications shall be stored within the U.S.P. recommended temperature range of 59 - 86°F unless the manufacturer's labeling suggests otherwise.

8.4.4.1.3 Prescription medication requiring refrigeration shall be stored in a separate and secure locked container within the refrigerator. The temperature range must be maintained within U.S.P. requirements.

8.4.4.1.4 Schedule II substances/prescriptions shall be kept in separately locked, securely fixed boxes or drawers in the locked medication cabinet; hence, under two (2) locks.

Schedule II substances shall be handled in the manner outlined by the State and Federal laws and regulations. AD unused Schedule 11 substances shall be returned to the pharmacist for disposition.

8.4.4.1.5 Internal medications shall be stored separately from external medications.

8.4.4.2 The group home provider shall insure that prescription medication is not used by other than the resident for whom the medication was prescribed.

8.4.4.3 The group home provider is responsible for maintaining an adequate supply of medication at all times.

8.4.4.4 Prescription medication which is no longer needed by a resident shall be disposed of by a physician, pharmacist or other designee who must be a licensed medical professional in accordance with Delaware Board of Pharmacy Regulations. All unused portions of any resident's discontinued or expired prescriptions shall be immediately isolated and destroyed or returned to the pharmacist or provider pharmacy supplying pharmaceutical services within 72 hours. The appropriate notation of such return or destruction, providing a quantity, description and date on the resident's medical administration record shall be prowled. The person performing the return or destruction shall initial this document.

8.4.4.5 The facility may keep on the premises an emergency drug kit with quantities of medications approved by the Board of Pharmacy. These medications shall only be used by licensed physicians or licensed nurses in an emergency situation. Stocking of this kit shall be arranged with a pharmacist who checks the contents after use and/or periodically.

8.5 Food Service:

8.5.1 A minimum of three (3) meals or equivalent shall be served in each twenty-four (24) hour period. Meals shall be served at regular times comparable to normal mealtimes in the community. There must not be more than a fourteen (14) hour span between the evening meal and breakfast.

8.5.2 Meals shall provide nutrients and calories for each resident based upon compliance with current recommended dietary allowances of the Food and Nutrition Board of the National Academy of Sciences, National Research Council, except as ordered by a physician.

8.5.3 Food preparation methods that conserve nutrients shall be utilized. Excessive exposure to light, prolonged storage, and prolonged cooking in a large quantity of water shall be avoided.

8.5.4 Food shall be prepared so that it will have an appetizing aroma and appearance. Food shall be held and served at proper temperatures in accordance with the current Delaware Food Code.

8.5.5 Food shall be prepared in a form designated to meet individual needs.

8.5.6 When residents refuse food served, substitutes of similar nutritive value shall be offered.

8.5.7 Bedtime snacks shall be offered routinely to all residents to the extent medical orders permit.

8.5.8 Diets and nutritional supplements shall be saved as prescribed by the physician. Meal and supplement intake shall be monitored by nursing service personnel and recorded in each resident's clinical record.

8.5.9 A copy of a recent diet manual shall be available for planning therapeutic menus and as a resource.

8.5.10 Menus shall be planned in advance and a copy of the current week's menus shall be posted in the kitchen and in a public area.

8.5.10.1 Portion sizes shall be listed on a menu in the food service area.

8.5.10.2 The names of fruit, vegetables or starch shall be specified on the menu (for example: orange juice, green beans, rice).

8.5.10.3 All menus, both regular and therapeutic, shall be approved by the dietitian.

8.5.11 Menus showing food actually served each day shall be kept on file for at least one (1) month. When changes in the menu are necessary, substitutions of similar nutritive value shall be provided.

8.5.12 A three (3) day supply of food shall be kept on the premises at all times.

8.5.13 A suspected occurrence of food poisoning shall be reported immediately, by telephone, to the County Public Health Administrator.

8.6 Nutrition Services

8.6.1 The facility must employ a dietitian directly or through contractual arrangements, either full time, part time or on a consultant basis, and provide on-site services to residents as needed.

8.6.2 The immediate nutritional needs of residents shall be addressed upon admission with consultation by the dietitian as needed. A comprehensive nutritional assessment which includes height and weight and an evaluation of calories, protein and fluid requirements shall be completed by the dietitian and updated and reviewed as indicated by the resident's condition.

8.6.3 The facility shall obtain residents' weights monthly or more often as needed.

8.6.4 Weight changes of 5 pounds or 5% of body weight in one month shall be reported to the physician and dietitian.

8.7 Records and Reports:

8.7.1 There shall be a separate clinical record maintained at the group home on each resident which shall be a chronological history of the resident's stay in the group home. Each resident's records shall contain:

8.7.1.1 Admission record: Including resident's name, birth date, home address prior to entering the facility, identification numbers, such as social security, Medicaid, Medicare, date of admission, physician's name, address and phone number, admitting diagnosis, next of kin (relationship, name, address and phone number).

8.7.1.2 History and physical examination: Prepared by physician within seven (7) days of the resident's admission. A summary and history which was prepared at the hospital and the resident's physician examination which was performed at the hospital, if performed within seven (7) days prior to admission to the home, may be substituted. Additionally, a record of an annual medical evaluation performed by a physician must be contained in each resident's file.

8.7.1.3 Statement of complete diagnosis and prognosis.

8.7.1.4 Physician's orders shall include:

8.7.1.4.1 Complete list of medications, medication name, dosage, frequency and route of administration, indication for usage;

8.7.1.4.2 If "as needed" medications are ordered, the reason why the resident takes the medication and the maximum dose in a 24 hour period;

8.7.1.4.3 Treatments, diets and level of permitted activity.

8.7.1.5 Physician's progress notes with each on-site visit. If medical services are obtained in the physician's office a summary including diagnosis and prognosis, changes in medication mid therapy and necessary follow-up will be provided.

8.7.1.6 Nursing notes, shall be recorded by each person providing professional nursing services to the resident, indicating date, time, scope of service provided and signed by the provider of the service.

8.7.1.7 Medication sheets: Including medication, name, dosage, frequency and route of administration, space for the resident to record his/her initials if medication is self-administered or for recording the initials of the medical professional authorized and responsible for administration of the medication.

8.7.1.8 Inventory of personal effects both upon admission and at time of transfer and/or discharge.

8.7.1.9 For discharged or transferred residents, the records shall contain the following:

8.7.1.9.1 A discharge summary containing the:

8.7.1.9.1.1 Date and time of discharge,

8.7.1.9.1.2 Place to which the resident was discharged;

8.7.1.9.1.3 Condition of resident at time of discharge.

8.7.1.9.2 The resident's written consent for discharge or discharge order from the resident's physician.

8.7.1.9.3 Copies of the name of the resident's guardian, powers of attorney and advance directives, if applicable.

8.7.1.10 Special service notes: e.g., social services and activities, results of special consultations, requested by the physician such as physical therapy, dental and podiatry if services me provided in the group home.

8.7.1.11 Nutrition progress notes.

8.7.1.12 Copy of an interagency transfer form if the resident was admitted from an acute care facility or any other long term care facility or transferred to an acute care or other type of health care facility.

8.7.1.13 Documentation of the percentage of intake for each meal.

8.7.1.14 Recording of weights obtained including the date the weight was obtained.

8.7.1.15 Laboratory work, special tests, and x-rays ordered by the physician.

8.7.2 Records shall be available at all times to legally authorized persons; otherwise, such records shall be held confidential.

8.7.3 Clinical records shall be retained for five (5) years from the date of discharge.

8.7.4 Should the facility cease operation, all resident records shall be transferred with the resident to another home or facility, with written receipt acknowledging the transfer which shall be signed by the resident and the new administrator.

8.7.5 If a facility ceases operation, arrangements, shall be made to retain discharge records for five (5) years following closure.

8.7.6 Incident reports, with adequate documentation, shall be completed for each incident. Adequate documentation shall consist of the name of the resident(s) involved; the date, time and place of the incident; a description of the incident; a list of other parties involved, including witnesses; the nature of any injuries; resident outcome; and follow-up action, including notification of the resident's representative or family, attending physician and licensing or law enforcement authorities when appropriate.

Incident reports shall be kept on file in the facility. Reportable incidents shall be communicated immediately to the Division of Long Term Care Residents Protection, 3 Mill Road, Suite 308, Wilmington, DE 19806; phone number: 1-877-453-0012; fax number: 1-877-264-8516.

**History**
- *5 DE Reg. 1079 (11/01/01)*
- *25 DE Reg. 762 (02/01/22)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *14 DE Reg. 1360 (06/01/11)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *15 DE Reg. 192 (08/01/11)*
- *5 DE Reg. 1079 (11/01/01)*
- *25 DE Reg. 762 (02/01/22)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *25 DE Reg. 762 (02/01/22)*

##### **16 Del. Admin. Code § 3301-9.0** Waiver of Standards {#sec-3301-9.0 omnilex-key=us-de-regs-official--title-16--3301-9.0}

9.1 Specific standards may be waived by the Division provided that each of the following conditions are met:

9.1.1 Strict enforcement of the standard would result in unreasonable hardship on the group home.

9.1.2 The waiver is in accordance with the particular needs of any resident of the group home.

9.1.3 A waiver must not adversely affect the health, safety, welfare, or rights of any resident of the group home.

9.1.4 The request for a waiver must be made to the Division in writing by the group home with substantial detail justifying the request.

9.1.5 Prior to filing a request for a waiver, the facility shall provide written notice of the request to each resident, each court-appointed guardian of any resident, each person appointed in the durable power of attorney of any resident, each person appointed to be any resident's health care agent under the Death with Dignity Act and each spouse and adult child of any resident. Prior to filing a request for a waiver, the facility shall also provide written notice of the request to the Office of Long Term Care Ombudsman. The notice shall state that the recipient has the right to object to the waiver request in writing to the Division.

9.1.6 A waiver granted by the Division is not transferable to another group home in the event of a change of ownership.

9.1.7 A waiver shall be granted for a period up to the term of the license.

PART II

APPENDIX A

Notifiable Diseases

Acquired Immune Deficiency Syndrome (S)

Anthrax (T)

Botulism (T)

Brucellosis

Campylobacteriosis

Chancroid (S)

Cholera

Cryptosporidiosis

Cyclosporidiosis

Diphtheria (T)

E. Coli 0157:H7 infection (T)

Encephalitis

Ehrlichiosis

Foodborne Disease Outbreaks (T)

Giardiasis

Gonococcal infections (S)

Granuloma Inguinale (S)

Hansen's Disease (Leprosy)

Hantavirus infection (T)

Hemolytic uremic syndrome (HUS)

Hepatitis A (T)

Hepatitis B (S)

Hepatitis C & unspecified

Herpes (congenital) (S)

Herpes (genital) (N)

Histoplasmosis

Human Immunodeficiency Virus (HIV) (N)

Human papillomavirus (genital warts) (N)

Influenza (N)

Lead Poisoning

Legionnaires Disease

Leptospirosis

Lyme Disease

Lymphogranuloma Venereum (S)

Malaria

Measles

Meningitis (all types other than meningoccal)

Meningococcal infections (all types) (T)

Mumps (T)

Pelvic Inflammatory Disease (resulting from Chlamydia trachomatis infections (S) gonococcal and/or chlamydial infections) (S)

Pertussis (T)

Plague (T)

Poliomyelitis (T)

Psittacosis

Rabies (man, animal) (T)

Reye's Syndrome

Rocky Mountain Spotted Fever

Rubella (T)

Rubella (congenital)(T)

Salmonellosis

Shigellosis

Smallpox (T)

Streptococcal disease (invasive group A)

Streptococcal toxic shock syndrome

(STSS)

Syphilis (S)

Syphilis (congenital) (T)

Tetanus

Toxic Shock Syndrome

Trichinosis

Tuberculosis

Tularemia

Typhoid Fever (T)

Vaccine Adverse Reactions

Varicella

Waterborne Disease Outbreaks (T)

Yellow Fever (T

(T) report by rapid means

(N) report in number only when so requested

For all diseases not marked by (T) or (N):

(S) - sexually transmitted disease, report

required in 1 day

Others - report required in 2 days

APPENDIX B

Drug Resistant Organisms Required to be Reported

Staphylococcus aureus intermediate or resistance to Vancomycin (MIC > 8 ug/ml)

Streptococcus pneumoniae drug resistant, invasive disease

**History**
- *5 DE Reg. 1079 (11/01/01)*
- *25 DE Reg. 762 (02/01/22)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *14 DE Reg. 1360 (06/01/11)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *15 DE Reg. 192 (08/01/11)*
- *5 DE Reg. 1079 (11/01/01)*
- *25 DE Reg. 762 (02/01/22)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *5 DE Reg. 1079 (11/01/01)*
- *25 DE Reg. 762 (02/01/22)*

#### **3305** Group Homes for Persons with Mental Illness

##### **16 Del. Admin. Code § 3305** Group Homes for Persons with Mental Illness {#sec-3305 omnilex-key=us-de-regs-official--title-16--3305}

PART I - STATE APPROVAL

**History**
- *25 DE Reg. 764 (02/01/22)*
- *14 DE Reg. 1360 (06/01/11)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *6 DE Reg. 323 (09/01/02)*
- *6 DE Reg. 654 (11/01/02)*
- *25 DE Reg. 764 (02/01/22)*

##### **16 Del. Admin. Code § 3305-1.0** Purpose {#sec-3305-1.0 omnilex-key=us-de-regs-official--title-16--3305-1.0}

The Department is issuing these regulations to promote the health, safety and well-being of all residents of group homes. These regulations are also meant to insure that service providers will be accountable to their residents and the Department. They are not intended to limit additional contract standards for community support programs with which a service provider may be expected to comply.

**History**
- *25 DE Reg. 764 (02/01/22)*
- *14 DE Reg. 1360 (06/01/11)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *6 DE Reg. 323 (09/01/02)*
- *6 DE Reg. 654 (11/01/02)*
- *25 DE Reg. 764 (02/01/22)*

##### **16 Del. Admin. Code § 3305-2.0** Authority and Applicability {#sec-3305-2.0 omnilex-key=us-de-regs-official--title-16--3305-2.0}

The Department is authorized by 16 Del.C., Ch. 11 to license and regulate group homes for adults. These regulations shall apply to group homes as defined in Section 3.0. These regulations address the minimum acceptable level of living and programmatic conditions for residents of group homes. The term "Group Homes for Persons with Mental Illness" shall not be used as part of the official name of any facility in this State, unless it has been so licensed by the Department.

**History**
- *25 DE Reg. 764 (02/01/22)*
- *14 DE Reg. 1360 (06/01/11)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *6 DE Reg. 323 (09/01/02)*
- *6 DE Reg. 654 (11/01/02)*
- *25 DE Reg. 764 (02/01/22)*

##### **16 Del. Admin. Code § 3305-3.0** Definitions {#sec-3305-3.0 omnilex-key=us-de-regs-official--title-16--3305-3.0}

The following terms found in these regulations shall have these specific meanings:

"Department" - The Department of Health and Social Services, the legal successor to the State Board of Health.

"Group Home" - Group home residence to provide mental health treatment, rehabilitation and housing, staffed substantially full-time when residents are present for between three (3) and ten (10) adults with primary diagnosis of psychiatric disabilities, licensed pursuant to 16 Del.C., Section 1101. Group home does not include supervised apartments or a residence licensed as an ICF/MR group home or neighborhood home under 16 Del.C., Ch. 11.

“Incident" - An occurrence or event, a record of which must be maintained in facility files, that results or might result in harm to a resident. Incident includes alleged abuse, neglect, mistreatment and financial exploitation; incidents of unknown source which might be attributable to abuse, neglect or mistreatment; all deaths; falls; and errors or omissions in medication/treatment.

"Program" - System of treatment and residential services developed by the service provider for use in a group home.

"Reportable Incident" - An occurrence or event which must be reported at once to the Division of Health Care Quality and for which there is reasonable cause to believe that a resident has been abused, neglected, mistreated or subjected to financial exploitation. Reportable incident also includes an incident of unknown source which might be attributable to abuse, neglect or mistreatment; all deaths; falls with injuries; and significant errors or omissions in medication/treatment which cause the resident discomfort or jeopardize the resident's health and safety.

"Residence Manager" - An individual meeting the requirements for a Clinician as contained in Section 5.3.1.1.2 and to whom the overall responsibility for the day to day operation of the group home has been delegated by those persons with the legal authority to manage the affairs of the entity.

"Resident" - An individual who lives in a group home. As the context may require, the term resident may also refer to the individual's legal representatives.

"Resident's Treatment Team" - A group consisting of a psychiatrist, residence manager, resident and other professionals with expertise or background relevant to the resident's needs and supports.

"Satisfactory Compliance History" - Any facility operated by the applicant in any state or other jurisdiction that has not had a license revoked, terminated or otherwise withdrawn by the issuing authority or voluntarily surrendered a license during a period of restriction or regulatory investigation of incidents involving serious harm, injury, impairment or death of a resident within the past five (5) years.

"Service Provider" - A legally recognized entity (e.g. corporation, partnership, sole proprietorship) required to be licensed under Section 2.0.

**History**
- *25 DE Reg. 764 (02/01/22)*
- *14 DE Reg. 1360 (06/01/11)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *6 DE Reg. 323 (09/01/02)*
- *6 DE Reg. 654 (11/01/02)*
- *25 DE Reg. 764 (02/01/22)*

##### **16 Del. Admin. Code § 3305-4.0** Licensing by the Department {#sec-3305-4.0 omnilex-key=us-de-regs-official--title-16--3305-4.0}

4.1 The service provider shall maintain a license issued by the Department for each group home. The license shall be posted in a conspicuous place in the group home to which it applies. The license shall not be transferable directly or indirectly from one service provider to another.

4.2 Separate licenses are required for group homes maintained in separate locations, even though operated by the same service provider. A license shall not be transferable from one group home to another or from one location to another.

4.3 Application for a license for a group home shall be made on forms provided by the Department. The application shall bear the notice that false statements therein are punishable. The application shall be accompanied by:

4.3.1 Certification that the service provider shall comply with all applicable state and federal laws including, but not limited to, non-discrimination based on age, sex, race, nationality, religion, sexual orientation, or disability, including the Americans with Disabilities Act, Section 504 of the Rehabilitation Act of 1973, and the Fair Housing Act;

4.3.2 A sworn affidavit of a satisfactory compliance history as defined in 16 Del.C., §1104(d) and other information to substantiate a satisfactory compliance history relating to each state or other jurisdiction in which the applicant operated a facility any time during the five year period preceding the date on which the application is made.

4.3.3 The applicable license fee;

4.3.4 Training and staff development plans offered by the service provider to staff, required by Section 5.3.2.;

4.3.5 Written operations and personnel policies & procedures manual, and quality assurance plan required by Sections 5.0 and 7.10;

4.3.6 A set of program plans which describe the service provider's capacity to implement Section 7.2.5;

4.3.7 Written policies on periodic physical examinations, required by Section 9.3;

4.3.8 Evidence of the ability to transport residents on an as needed basis, including provisions for emergency transportation, required by Sections 12.10 and 12.11;

4.3.9 Written policies on medication maintenance and storage, required by Sections 10.;

4.3.10 A letter from the Fire Marshal having jurisdiction certifying compliance by the group home with the rules and regulations of the State Fire Prevention Commission, required by Section 14.1;

4.3.11 An evacuation plan required by Section 14.5;

4.3.12 A staffing and work schedule;

4.3.13 An identification of those persons and entities listed in 16 Del.C., §1104(c);

4.3.14 An outline of arrangements for the provision of primary medical, emergency medical and dental care, in addition to access to community support services such as employment and day programming;

4.3.15 An operating budget;

4.3.16 A blueprint (or similar plan) of the group home;

4.3.17 A specific plan for the safe and confidential storage of residents' records and medication including anticipated compliance with Section 8.1 and Section 10.0.

4.4 The Department shall grant a provisional license to any new applicant provided that the requirements of these regulations are met. The term of such provisional license shall be ninety (90) days, and thereafter, the applicant shall be entitled to an annual license, provided that the requirements of these regulations are met.

4.5 All applications for renewal of licenses shall be filed with the Department at least ninety (90) days prior to expiration and shall be accompanied by the attachments set forth in Section 4.3. Licenses may be issued for a period not to exceed one year (12 months) from the date of issuance.

4.6 The program will affirmatively notify the Department of any change in circumstances which precludes compliance with any of the regulations of this part.

4.7 The Department shall monitor compliance with its regulations and procedures. The service provider shall make all documentation and records deemed necessary by the Department available for the Department's review, and site visits shall be permitted at any time. The Department shall have the right of access to any information directly or indirectly related to the service provider's operation of the group home.

4.8 A service provider shall operate the group home in accordance with its application for licensure. A service provider shall immediately report any deviations from such operation to the Department.

4.9 The service provider shall cooperate fully with the state protection and advocacy agency, as defined in 16 Del.C. §1102(7), in fulfilling functions authorized by Title 16, Chapter 11.

PART II - ADMINISTRATION

**History**
- *25 DE Reg. 764 (02/01/22)*
- *14 DE Reg. 1360 (06/01/11)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *6 DE Reg. 323 (09/01/02)*
- *6 DE Reg. 654 (11/01/02)*
- *25 DE Reg. 764 (02/01/22)*

##### **16 Del. Admin. Code § 3305-5.0** Policies and Procedures Manual {#sec-3305-5.0 omnilex-key=us-de-regs-official--title-16--3305-5.0}

5.1 The service provider shall maintain and comply with a written procedures manual for its staff. A mechanism shall be in place to ensure that this manual is updated continuously to comply with changes in state and/or federal laws and regulations. The staff of the group home is to be notified promptly of changes. The manual shall be composed of two (2) sections, Operations and Personnel, as follows:

5.2 Operations

5.2.1 A statement of the group home program's values, mission and objectives;

5.2.2 Policies and procedures that:

5.2.2.1 Facilitate resident referral, admission, and discharge;

5.2.2.2 Provide detailed instructions for assessment, service planning and documentation procedures;

5.2.2.3 Describe the handling of on-call responsibilities and resident emergencies;

5.2.2.4 Provide detailed instructions for application to, and communication with, public benefit agencies such as Medicaid, Medicare, Division of Vocational Rehabilitation, etc.;

5.2.2.5 Outline the conditions underlying the lawful sharing of information about residents with family members or others;

5.2.2.6 Provide direction regarding handling financial resources of the group home;

5.2.2.7 Describe the management of residents' funds for whom the service provider has been designated payee;

5.2.2.8 Outline the management of resident medication and the monitoring of medication effects;

5.2.2.9 Involve the services of a crisis intervention service in the event of psychiatric emergencies;

5.2.2.10 Comply with state and federal laws and regulations for receiving and resolving resident grievances;

5.2.2.11 Describe the process of resident transition or termination from the program which is in compliance with state and federal laws and regulations and are intended to ensure continuity of service;

5.2.2.12 In conformity with 16 Del.C., Ch. 11, describe the system for reporting and processing of abuse/neglect, mistreatment and/or financial exploitation allegations;

5.2.2.13 Describe a procedure for open communication with other residents of the community in which the home is located in order to facilitate group home residents' integration and social skills development; and

5.2.2.14 Include a provision for the development of any other policies and procedures otherwise required to be included by Departmental policy.

5.3 Personnel

5.3.1 Staff

5.3.1.1 The minimum qualifications for staff associated with a group home shall be as follows:

5.3.1.1.1 Psychiatrist: A psychiatrist shall be a person with a medical degree or Doctor of Osteopathy degree, who is licensed to practice medicine in Delaware and is board certified in psychiatry or has served a residency in psychiatry.

5.3.1.1.2 Clinician: A clinician shall be a person with a doctoral or master's degree in clinical or counseling psychology, clinical social work, vocational/psychiatric rehabilitation or education from an accredited college or university; a registered nurse with certification in mental health nursing from the American Nurses Association; or a person with a bachelor's degree with five (5) years experience in mental health service delivery with at least two (2) years experience in residential services.

5.3.1.1.3 Associate Clinician: An associate clinician shall be a person with a bachelor's degree in clinical or counseling psychology, social work, nursing, vocational/psychiatric rehabilitation, education or other mental health field from an accredited college or university; or a registered nurse. An associate clinician shall have had direct experience in mental health service.

5.3.1.1.4 Residential Service Assistant: A residential service assistant shall be a person who has a high school diploma or GED.

5.3.1.2 The group home shall have a residence manager who shall be responsible for the operation of the group home and shall have the qualifications as defined in Section 5.3.1.1.2 The residence manager shall be responsible for the supervision of residents' treatment plans.

5.3.1.3 Associate Clinicians and Residential Service Assistants shall have qualifications for the treatment activities in which they engage and shall be supervised by the residence manager. At least seventy-five (75) percent of the group home staff, including the residence manager, shall be clinicians or associate clinicians. Nothing in these regulations shall be construed to exempt or limit the application of professional licensing requirements, including those pertaining to professional counselors, psychologists, and clinical social workers under 24 Del.C., Chs. 30, 35, and 39, respectively.

5.3.1.4 The service provider shall maintain a current personnel policies and procedures manual that sets forth grounds for termination, adequately supports sound resident care and is made readily available to the program's staff in each home. The service provider shall comply with the provisions of such manual. The manual shall contain an explanation of the residents' rights pursuant to 16 Del.C. §1121 and applicable federal law.

5.3.1.5 The service provider shall comply with criminal background check and drug testing laws [16 Del.C., Sections 1141 and 1142] and implementing regulations.

5.3.2 Training and Core Competencies

5.3.2.1 The above staff shall meet competency and training standards compiled by the Department.

5.3.2.2 In order to be approved by the Department, the training required of the service provider staff shall, at a minimum, include each of the following topics:

5.3.2.2.1 A complete course in medications used in the treatment of mental illness including the medications' effects and side effects used alone or in combination with other prescription and non-prescription medication and alcoholic or caffeinated beverages;

5.3.2.2.2 A course in mental illness including symptoms of the major mental illnesses, mood and personality disorders and indications of deterioration of an individual's mental condition;

5.3.2.2.3 A course in first aid, including CPR training;

5.3.2.2.4 An explanation of the rights of adults with psychiatric disabilities in residential care in Delaware;

5.3.2.2.5 Expectations for confidentiality and ethical behavior towards residents who will reside in the group home;

5.3.2.2.6 Policies and procedures that apply to a group home on both a daily and emergency basis;

5.3.2.2.7 Fire safety and evacuation procedures;

5.3.2.2.8 Health care, sanitation, and safe handling of food;

5.3.2.2.9 Familiarization with community mental health services available in the county in which the group home is located;

5.3.2.2.10 Orientation to situational counseling, behavioral deescalation techniques, stress management and social interaction.

5.3.2.2.11 Training in appropriate activities and entertainment for residents;

5.3.2.2.12 Demonstration of a clear understanding of these regulations; and

5.3.2.2.13 A plan for the continuing education and development of staff.

5.3.2.3 This list of topics is not intended to be exhaustive and shall in no way limit the training requirements set forth by the Department.

5.3.2.4 A service provider need not require training in discrete areas in which the staff person has demonstrated competency through satisfactory job performance or previous experience to the satisfaction of the service provider and the Department.

5.3.2.5 Staff may be provisionally hired and perform job duties pending completion of training within thirty (30) days. Such provisional staff shall not be on duty without on-site supervision.

PART III - PROGRAM

**History**
- *25 DE Reg. 764 (02/01/22)*
- *14 DE Reg. 1360 (06/01/11)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *6 DE Reg. 323 (09/01/02)*
- *6 DE Reg. 654 (11/01/02)*
- *25 DE Reg. 764 (02/01/22)*

##### **16 Del. Admin. Code § 3305-6.0** Admission and Discharge {#sec-3305-6.0 omnilex-key=us-de-regs-official--title-16--3305-6.0}

Admission

6.1 The purpose of a group home is to provide a supportive and rehabilitative environment for consumers of mental health services who are unable to live independently at a given time, who demonstrate a willingness to develop the skills for independent living, and who would benefit from group living as an alternative to their existing living situation.

6.2 A service provider shall ensure that no applicant is denied any benefits or services or is subject to illegal discrimination based on age, sex, race, nationality, religion, sexual orientation or disability.

6.3 Unless otherwise authorized by statute, admission to a group home shall be limited to adults with a psychiatric disability who apply for admission to the group home, meet the criteria contained in Section 6.4, and require intensive home and community-based support services as a result of the degree of their psychiatric disability.

6.4 In order to be accepted as a resident of a group home, the following criteria must be met:

6.4.1 Be eighteen (18) years of age or older;

6.4.2 Require a twenty-four (24) hour supervised community residence because of a primary diagnosis of serious mental illness and not require the services of a psychiatric hospital;

6.4.3 Agree to abide by the rules and regulations of the program;

6.4.4 Be assessed not likely to be dangerous consistent with the following standard:

6.4.4.1 Individuals shall not be eligible for group home admission if their residency, even with reasonable accommodation, would either constitute a direct threat to the health or safety of self or others, or result in substantial physical damage to the property of others. Such determination shall be made on an individualized basis by a multi-disciplinary team of the group home, which shall include a psychiatrist.

6.4.4.2 Individuals shall agree to comply with treatment plans.

6.4.5 Not be a current user of illegal drugs during the assessment period. A drug-screening test may be required to demonstrate the remission or current nonuse of illegal drugs at the time of admission.

6.5 Prior to admission, the service provider shall provide the applicant or legal representative an admission agreement, including the following:

6.5.1 An itemized statement of services, equipment, and supplies expected to be furnished to the applicant during the period of residency;

6.5.2 The cost and expected source of funding for each item, highlighting any items chargeable to the applicant's personal funds;

6.5.3 Discharge standards;

6.5.4 By attachment, the Patients' Bill of Rights Act (16 Del.C., §1121). Receipt shall be acknowledged by signature of the applicant or legal representative and retained in the service provider's file; and

6.5.5 Each provider shall adopt a reasonable fee schedule, which shall be shared with an applicant in writing prior to admission and at such intervals thereafter as prescribed by the Department. Fees charged residents receiving state and/or federal financial assistance shall not exceed amounts available to such persons under law. Residents of all group homes shall be given thirty (30) days written notice of any increase in fees.

6.6 The service provider shall complete an assessment, using a format approved by the Division of Substance Abuse and Mental Health, prior to each resident's admission to the group home with the assistance of the group home's psychiatrist.

A written summary of the assessment completed by the applicant's primary clinician must be clearly explained to the applicant. The summary of the assessment shall address, at a minimum, the following:

6.6.1 Current psychiatric or behavioral health symptomatology and mental status;

6.6.2 Compliance with and response to prescribed medical/psychiatric treatment;

6.6.3 Medical, dental, and visual needs;

6.6.4 Recent key life events and current social functioning;

6.6.5 Vocational and educational functioning;

6.6.6 Accommodations and supports to facilitate activities of daily living;

6.6.7 Recommendations pertaining to limitations on the applicant's diet or activities, if any, signed by a licensed physician; and

6.6.8 Drug and alcohol history and history of assaultive behavior up to five (5) years prior to institutionalization.

6.7 Based on the results of the assessment, the service provider and resident shall develop an initial individualized treatment plan no later than the date of the resident's admission to the group home. The service provider shall comply with the provisions of such plan. Copies of such plan and all amendments shall promptly be provided to the resident. In addition, copies of such plans shall be maintained for each resident at the resident's group home and shall be available for inspection by the Department upon request.

6.8 Discharge. Consistent with 16 Del.C., Section 1121, a provider may seek discharge of a resident for good cause. Prior to discharge, the provider shall ensure the development of a written discharge plan in consultation with the resident; his guardian or legal representative, if any; anticipated post-discharge providers; and a multidisciplinary team which shall include a psychiatrist.

6.8.1 Content of a Discharge Plan

At a minimum, the discharge plan shall include:

6.8.1.1 A realistic assessment of the resident's post discharge social financial, vocational, housing, and treatment needs;

6.8.1.2 Identification of available support services and provider linkages necessary to meet the assessed needs; and

6.8.1.3 Identification and a timetable of discrete, predischarge activities necessary to promote the resident's successful transition to the post-discharge setting.

6.8.2 Good Cause

Good cause for discharge includes the following:

6.8.2.1 The resident has demonstrated the ability and willingness to live in a less restrictive setting;

6.8.2.2 The resident, even with reasonable accommodation, poses either a direct threat to the health or safety of self or others; or direct threat of substantial physical damage to the property of others;

6.8.2.3 The resident requires a level of care beyond the scope of that reasonably available within the group home; or

6.8.2.4 The resident has materially violated essential rules of operation of the group home and such violation seriously affects the welfare of the resident or other residents of the group home.

6.9 A resident to be discharged shall be given thirty (30) days prior notice of the discharge and the reasons therefore, and shall be entitled to an impartial hearing to challenge the discharge. In emergency situations, a resident may be discharged without notice and a hearing, provided that as soon as practical a resident will be provided an opportunity to challenge the discharge through a hearing after the discharge has occurred, and further provided that no resident may be discharged before the service provider develops and implements an emergency discharge plan adequate to protect the resident's safety and welfare until the discharge hearing.

The emergency plan shall address the resident's need for housing. For purposes of this subsection, a situation is an emergency when the behavior of a resident is causing or threatens to imminently cause physical injury or death to the resident, other residents, staff, or others.

No resident shall be discharged on an emergency basis without prompt notification to the Division of Substance Abuse and mental Health.

6.10 Short-term transfer to a medical treatment setting, including a psychiatric hospital, shall not result in discharge.

**History**
- *25 DE Reg. 764 (02/01/22)*
- *14 DE Reg. 1360 (06/01/11)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *6 DE Reg. 323 (09/01/02)*
- *6 DE Reg. 654 (11/01/02)*
- *25 DE Reg. 764 (02/01/22)*

##### **16 Del. Admin. Code § 3305-7.0** Care, Treatment and Quality Assurance {#sec-3305-7.0 omnilex-key=us-de-regs-official--title-16--3305-7.0}

7.1 The service provider shall operate the group home in a manner such that residents will be able to maximize their quality of life as a result of the following:

7.1.1 Involvement and choice in all aspects of their care, rehabilitation and support;

7.1.2 Development and maintenance of supportive social networks;

7.1.3 Access to services, programs, and activities in the most integrated setting; and

7.1.4 Access to rehabilitative support during the course of day to day activities.

7.2 The following requirements represent minimum guidelines to implement these principles:

7.2.1 The service provider shall maintain the following staffing pattern:

7.2.1.1 Between the hours of 8 AM and 10 PM:

7.2.1.1.1 A minimum of one (1) clinician or associate clinician shall be on duty and on site for every one (1) to five (5) residents present in the home.

7.2.1.1.2 A minimum of two (2) staff members, at least one (1) of whom shall be a clinician or associate clinician, shall be on duty and on site whenever six (6) or more residents are present in the home.

7.2.1.2 At all other times, a minimum of one (1) clinician or associate clinician shall be on duty and on site whenever any residents are present in the home.

7.2.1.3 At all times, at least one (1) clinician, associate clinician, or residential service assistant shall be available on call. When a staff member is on duty and on site alone, the on-call person must be a clinician or associate clinician.

7.2.1.4 The Department may require a modified staffing pattern based on extenuating circumstances or resident need.

7.2.2 The service provider shall develop procedures for facility and resident emergencies/crises and shall train all staff to implement such procedures prior to their assumption of an in-home resident support role. Emergency procedures shall include prompt methods for acquiring assistance of the following: facility on-call and other appropriate staff; 911 personnel; and medical/psychiatric personnel, including the area's crisis intervention service and local hospital/medical aid unit's emergency room. Psychiatric on-call coverage must be available at all times.

7.2.3 Each resident shall have his/her progress and continuing treatment needs thoroughly reassessed at least once every six (6) months. The reassessment will be conducted by a the resident’s treatment team, which shall include a psychiatrist.

7.2.4 A service provider shall employ, or have under contract, a psychiatrist who shall participate in staff support and training, resident intake evaluation, emergency responses, and staff performance plans and reviews in each group home. This psychiatrist may be a physician other than the primary treating physician for one or all of the patients. The psychiatrist shall visit the group home at least once a week and spend a minimum of one-half hour per resident per month providing direct services to residents on site, participating in the assessment of residents' needs, planning service provision, and providing supervision/consultation to other program staff.

7.2.5 The service provider shall offer a full range of rehabilitation, treatment and support services for each resident including, but not limited to, the following:

7.2.5.1 Three hundred sixty-five (365) day per year services, with on-site staff available to make face-to-face contact on a twenty-four (24) hour basis;

7.2.5.2 Psychiatric treatment and linkage to community support programs or day hospital programs;

7.2.5.3 Clinical liaison during periods of psychiatric hospitalization;

7.2.5.4 Outreach and crisis response;

7.2.5.5 Social networking in an effort to promote a stable social network for the resident;

7.2.5.6 Support to ensure educational and vocational training opportunities and help residents to get and keep a job;

7.2.5.7 Teaching and counseling on-site to improve interpersonal skills and to assist residents to control psychiatric symptoms;

7.2.5.8 Support and assistance in on-site activities of daily living such as personal hygiene, care and grooming, and training in community living;

7.2.5.9 Support and assistance in the receipt of entitlements and social services;

7.2.5.10 Provision and encouragement of participation in activities outside of the home, to the maximum extent possible. In addition, providers shall create incentives for residents to become involved in the activities of their choice;

7.2.5.11 Transportation of residents to community activities; and

7.2.5.12 Support and encouragement to promote resident participation in mutual support and self-advocacy groups.

7.3 The service provider shall designate a clinician or associate clinician to be the primary clinician for each resident who shall:

7.3.1 Maintain the clinical file for the resident;

7.3.2 Conduct and participate in treatment planning and case conferences with other staff of the group home, and other appropriate agencies;

7.3.3 Maintain a therapeutic alliance with the resident;

7.3.4 Refer and link the resident to all needed services provided outside the program;

7.3.5 Follow up to ensure that all needed services provided outside of the group home are received and monitor the resident's benefit from those services;

7.3.6 Coordinate the provision of emergency services and hospital liaison services when a resident is in crisis;

7.3.7 Coordinate overall independent living assistance services and work with community agencies to develop needed resources including housing, employment options and income assistance; and

7.3.8 Support and consult with the resident's family.

7.4 The duties of the service coordinator notwithstanding, all staff of the program shall share responsibility for resident care to the extent they are credentialed to provide such care.

7.5 Within thirty (30) days of the resident's admission, the individualized treatment plan shall be revised and updated by the resident and the resident's treatment team.

7.6 The treatment plan shall include both short-range and long-range goals, stated in measurable terms and including criteria for revision of goals. It shall include the specific treatment, rehabilitation and support interventions, and their frequency, planned to achieve treatment goals.

7.7 The resident's participation in the development of treatment goals shall be documented. With the permission of the resident, the resident's treatment team shall engage the involvement of other service providers and members of the resident's social network in formulating treatment plans.

7.8 The treatment plan shall be prepared on forms which are subject to Departmental approval. It shall be signed by members of the resident's treatment team and the resident.

7.9 The treatment plan shall be reviewed in full at least every six (6) months by the resident and the resident's treatment team. The date, results of the review, and any changes in the treatment plan shall be recorded.

7.10 The service provider shall develop, implement, and adhere to a documented, ongoing, quality assurance program that includes an internal monitoring process that tracks performance and measures resident satisfaction.

**History**
- *25 DE Reg. 764 (02/01/22)*
- *14 DE Reg. 1360 (06/01/11)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *6 DE Reg. 323 (09/01/02)*
- *6 DE Reg. 654 (11/01/02)*
- *25 DE Reg. 764 (02/01/22)*

##### **16 Del. Admin. Code § 3305-8.0** Records {#sec-3305-8.0 omnilex-key=us-de-regs-official--title-16--3305-8.0}

8.1 The service provider shall maintain an on-site treatment record for each resident that includes sufficient documentation of assessments, treatment plans and treatment to permit a clinician not familiar with the resident to evaluate the course of treatment. Resident treatment records shall be kept confidential and safeguarded in a manner consistent with the requirements of 16 Del.C., §1121, applicable federal law and Departmental guidelines adopted in conformity with 16 Del.C., §1119 A.

The resident's records shall be maintained by the service provider in their entirety for at least seven (7) years after the date of discharge or as otherwise directed by the Department.

The resident's record shall contain the following:

8.1.1 An up-to-date face sheet and resident consent to treatment and consent to any occasion of release of treatment information;

8.1.2 Results of all pertinent examinations, tests and other assessment information, reports from referral sources and clinical consults, and hospital discharge summaries;

8.1.3 Assessments and summary of assessments;

8.1.4 A treatment plan;

8.1.5 Weekly and monthly progress notes;

8.1.6 Documentation of at least semiannual reviews of treatment, including reassessment of current functioning, summary of progress and treatment plan revisions;

8.1.7 Medication history and orders including the following:

8.1.7.1 The brand or established name and strength of medication to extent measurable;

8.1.7.2 Identity of dispensing pharmacy;

8.1.7.3 Identity of prescribing physician;

8.1.7.4 Date of order;

8.1.7.5 Dose;

8.1.7.6 Special instructions included on the prescription;

8.1.7.7 Frequency and, if specified, time period of intended administration; and

8.1.7.8 For each discrete self-administration/administration of medication, the following:

8.1.7.8.1 Time and date;

8.1.7.8.2 Amount or dose;

8.1.7.8.3 Route of administration;

8.1.7.8.4 Identity of person administering, assisting with administration, or, if applicable, monitoring self-administration of medication; and

8.1.7.8.5 Any adverse reactions.

8.1.8 Discharge plan developed in conformity with Sections 6.8, 6.9 and 6.10.

8.2 Incident reports, with adequate documentation, shall be completed for each incident. Adequate documentation shall consist of the name of the resident(s) involved; the date, time and place of the incident; a description of the incident; a list of other parties involved, including witnesses; the nature of any injuries; resident outcome; and follow-up action, including notification of the resident's representative or family, attending physician and licensing or law enforcement authorities when appropriate. Incident reports shall be kept on file in the facility. Reportable incidents shall be communicated immediately to the Division of Health Care Quality, 3 Mill Road, Suite 308, Wilmington, DE 19806; telephone number: 1-877-453-0012; fax number: 1-877-264-8516.

**History**
- *25 DE Reg. 764 (02/01/22)*
- *14 DE Reg. 1360 (06/01/11)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *6 DE Reg. 323 (09/01/02)*
- *6 DE Reg. 654 (11/01/02)*
- *25 DE Reg. 764 (02/01/22)*

##### **16 Del. Admin. Code § 3305-9.0** General Health Care {#sec-3305-9.0 omnilex-key=us-de-regs-official--title-16--3305-9.0}

9.1 The service provider shall ensure that residents receive needed medical, dental, visual and behavioral health care. Residents shall have a complete physical examination by a physician within thirty (30) days of admission to the group home unless they have had one within one (1) year of admission and their medical records are available to their current primary care physician.

9.2 The service provider shall identify generic medical services and the professional providing the services, including a physician and dentist, for each resident.

9.3 The service provider shall ensure that each resident has an annual physical exam.

9.4 The service provider shall ensure that dental evaluations and preventive care are provided at least annually.

9.5 Upon confirmation of a reportable disease, the service provider shall notify the appropriate County Health Officer of the Division of Public Health.

9.6 The service provider shall provide or arrange transportation for the resident's routine medical and dental care.

9.7 Unless otherwise prescribed, the daily diet for each resident shall include a minimum of three balanced meals a day.

9.8 The service provider shall immediately report, by telephone, a suspected occurrence of food poisoning to the County Health Officer of the Division of Public Health, and the resident's physician.

9.9 If the service provider's staff does not include a registered nurse, the service provider shall train sufficient staff to ensure that, at all times, one or more members of the staff on duty in the group home has basic knowledge in first aid (including CPR), prevention of disease, proper handling of food, and care of sick persons. Reference materials on nutrition, drugs, and illness shall be available to the staff.

9.10 All group homes shall have on file results of tuberculin tests performed annually for all group home staff and residents. Mantoux techniques (5TU-PPD-T) is the tuberculin skin test recommended by the Division of Public Health. The service provider shall report the test results of any staff or resident found to react significantly to the skin test (ten (10) mm induration or greater) to the Division of Public Health.

9.11 New group home staff and new residents fifty (50) years of age or older who have a nonsignificant reaction to the tuberculin test, defined as less than ten (10) mm induration, should be retested within ten (10) to fourteen (14) days to identify those who demonstrate delayed reactions.

9.12 Group home staff and residents who have a documented history of a significant tuberculin test should not be retested, ever. Clinical histories on such group home staff and residents should be taken and those with symptoms of pulmonary tuberculosis should have chest x-rays.

9.13 The Department may require a group home to conduct more frequent tuberculin screening should the Department judge that the risk of tuberculosis in the group home warrants such action.

**History**
- *25 DE Reg. 764 (02/01/22)*
- *14 DE Reg. 1360 (06/01/11)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *6 DE Reg. 323 (09/01/02)*
- *6 DE Reg. 654 (11/01/02)*
- *25 DE Reg. 764 (02/01/22)*

##### **16 Del. Admin. Code § 3305-10.0** Medications {#sec-3305-10.0 omnilex-key=us-de-regs-official--title-16--3305-10.0}

10.1 Medication monitoring is to be conducted as follows:

10.1.1 The psychiatrist shall evaluate each resident's response to prescribed medication at least every two (2) weeks;

10.1.2 The service provider shall monitor and document, as required in Section 8.1.7, resident compliance in following prescribed medication treatment and medication effects and side effects. The service provider shall assist the resident in reporting side effects to the psychiatrist or other physician prescribing the medication. Suspected drug reactions shall be noted in the medication record and reported to the psychiatrist immediately;

10.1.3 A registered nurse or licensed practical nurse may administer medications, including injections, at the direction of the prescribing physician; and

10.1.4 Residents shall retrieve and take their medications under the direct supervision of a qualified staff member except as specifically authorized by the treatment plan.

10.2 Residents receiving medication shall be trained to take their own medication, where possible. Staff who have successfully completed a Board of Nursing approved medication training program may assist residents in the taking of medication provided that the medication is in the original container and properly labeled. The medication must be taken exactly as indicated on the label.

10.3 No prescription medication shall be administered to a resident without an order by a physician or other legally authorized person.

10.4 No person other than a physician or licensed nurse shall administer injectable medication.

10.5 Group home staff shall immediately report medication errors to the prescribing physician.

10.6 A minimum of a three (3) day supply of each resident's medication shall be available at all times.

10.7 The service provider shall be responsible for the storage of medication. Medications not in the authorized possession of residents are to be kept in a locked cabinet or in a locked box in a refrigerator, in a locked room.

**History**
- *25 DE Reg. 764 (02/01/22)*
- *14 DE Reg. 1360 (06/01/11)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *6 DE Reg. 323 (09/01/02)*
- *6 DE Reg. 654 (11/01/02)*
- *25 DE Reg. 764 (02/01/22)*

##### **16 Del. Admin. Code § 3305-11.0** Resident Rights and Responsibilities {#sec-3305-11.0 omnilex-key=us-de-regs-official--title-16--3305-11.0}

11.1 Consistent with Section 4.3.1, residents may solicit, and the service provider shall consider, resident requests for reasonable accommodation based on disability. Residents should review their admissions agreements and shall have an opportunity to accept or reject admission to the group home program prior to enrollment.

11.2 Residents shall be kept informed through written guidelines and documentation in their clinical records of their rights and responsibilities contained in written policies and procedures including reference to:

11.2.1 Behavioral expectations and limitations including:

11.2.1.1 Prohibition against the use of alcohol or other drugs other than those prescribed by their physicians;

11.2.1.2 Respect for privacy rights of fellow residents and others and respect for laws regarding conduct outside the group home; and

11.2.1.3 Cooperation with treatment;

11.2.2 Confidentiality; and

11.2.3 All applicable appeal processes.

11.3 Each service provider shall maintain a fair, timely, and impartial grievance system, whose operational standards may be prescribed by the Department, to address resident complaints. The availability of such system shall not preclude or diminish a resident's right to pursue remedies in alternate forums, including those authorized by 16 Del.C., §§1121, 1125, and 1152.

11.4 Subject to 16 Del.C., §1121, the service provider shall adopt reasonable program or house rules which promote resident safety and responsibility without unnecessarily compromising individual self- determination and choice. On a case-by-case basis, a resident's treatment team may authorize a variance from application of such rules (e.g. during transition to and from the residence). Any variance that restricts personal activities within the general scope of adult discretion shall be based on clinical necessity and the specific rationale included in the resident's treatment plan.

11.5 The service provider shall comply with all applicable state laws, regulations, and policies regarding reporting and responding to allegations of abuse and neglect.

11.6 The service provider shall comply with the applicable posting and disclosure requirements of 16 Del.C., §1108.

11.7 The service provider shall comply with the Patient's Bill of Rights set forth in 16 Del.C., §1121. A copy of the Patient's Bill of Rights shall be conspicuously posted within the home.

PART IV - QUALITY AND SAFETY OF LIVING ARRANGEMENTS

**History**
- *25 DE Reg. 764 (02/01/22)*
- *14 DE Reg. 1360 (06/01/11)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *6 DE Reg. 323 (09/01/02)*
- *6 DE Reg. 654 (11/01/02)*
- *25 DE Reg. 764 (02/01/22)*

##### **16 Del. Admin. Code § 3305-12.0** Physical Facility Standards {#sec-3305-12.0 omnilex-key=us-de-regs-official--title-16--3305-12.0}

12.1 Rooms or other areas of the group home that are not sleeping rooms shall not be used for sleeping accommodations.

12.2 Sleeping rooms shall be rooms with one (1) outside wall and shall provide for quiet and privacy.

12.2.1 Each bedroom shall have walls that go to the ceiling, a door that can be closed and that opens directly into a corridor, and at least one (1) window that opens directly to the outside.

12.2.2 Bedrooms for one (1) individual shall be at least one hundred (100) square feet in size and bedrooms for more than one (1) individual shall provide at least eighty (80) square feet of floor space per individual and be adequately spaced for resident care. Minimum room measurements shall not include toilet rooms, closets, lockers, wardrobes, alcoves or vestibules. The ceiling shall not be less than seven (7) feet from the floor. Each bedroom shall accommodate no more than two (2) residents.

12.2.3 Each resident shall have a separate bed of appropriate size and height and in good repair with a comfortable, well-constructed mattress. There shall be closet space and a minimum of two (2) drawers in a chest of drawers for storing personal belongings. There shall be a sturdy bedside stand and reading light for each resident.

12.2.4 Electrical outlets shall be conveniently located in each room with at least one (1) light fixture switch at the entrance to the bedroom.

12.2.5 The service provider shall ensure adequate privacy and separation of sexes in sleeping arrangements, except in cases of husband and wife.

12.2.6 If bedroom doors of residents are locked by residents for privacy reasons, a master key shall be available to staff persons.

12.2.7 Bedroom windows shall have window treatments that close for privacy.

12.3 Every resident shall receive notice before the resident's room or roommate is changed, except in emergencies. The service provider shall endeavor to honor the room or roommate requests of the resident whenever possible. Smoking and non-smoking residents, where practical, shall not share a room except by mutual agreement.

12.4 There shall be a telephone in the group home accessible to staff and residents.

12.5 There shall be sufficient heating, ventilation, and light in all living and sleeping quarters to provide a comfortable atmosphere.

12.6 The exterior of the group home site shall be free from hazards as well as the accumulation of litter.

12.7 The group home and grounds shall be clean and orderly and maintained in an attractive appearance reasonably consistent with the character of the immediate area in which the group home is located.

12.8 There shall be provided one (1) or more areas that are adequate in size and furnished for resident dining, recreational, and social activities, and which shall include TV, radio and entertainment. At least thirty (30) square feet per resident shall be assigned to these areas. Basement space may be used for recreation activities if there is a minimum of two (2) means of egress from the basement.

12.9 Any physical alteration of a group home shall be approved by the Department in writing prior to the commencement of the alteration. One (1) copy of the building permit for the alteration, the application for the building permit and accompanying plans and specifications shall be submitted to the Department before the alteration may be considered.

12.10 All vehicles used to transport residents by the service provider shall be equipped with a seat belt for each resident, a means of communication, and shall comply with applicable safety and licensing standards established by the Delaware Division of Motor Vehicles. The service provider shall maintain liability insurance as required by Delaware law. A driver of a vehicle used to transport residents shall have a valid license.

12.11 Emergency transportation shall be available on a twenty-four (24) hour basis. Each group home shall demonstrate the ability to transport residents on an as-needed basis, including provisions for emergency transportation, as a condition of licensure.

**History**
- *25 DE Reg. 764 (02/01/22)*
- *14 DE Reg. 1360 (06/01/11)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *6 DE Reg. 323 (09/01/02)*
- *6 DE Reg. 654 (11/01/02)*
- *25 DE Reg. 764 (02/01/22)*

##### **16 Del. Admin. Code § 3305-13.0** Health and Sanitation {#sec-3305-13.0 omnilex-key=us-de-regs-official--title-16--3305-13.0}

13.1 The group home site shall be easily drained, suitable for the disposal of sewage, and furnished with a potable water supply that meets requirements of the appropriate State agencies.

13.2 The water system in the group home shall be designed to supply adequate hot and cold water, under pressure, at all times.

13.3 Hot water at shower, bathing and hand washing faucets in the group home shall not exceed 120º F.

13.4 The plumbing in the group home shall meet the requirements of all applicable municipal, county, and state codes. Where there are no municipal or county codes, the plumbing in the group home shall meet the provisions of the Department's Sanitary Plumbing Code.

13.5 There shall be private bathroom facilities with a toilet, shower or tub, and wash basin in each group home. These facilities shall be accessible to each resident according to his/her individual needs.

13.5.1 Traffic to and from any room shall not be through a bedroom or bathroom except where a bathroom opens directly off the room it serves.

13.5.2 There shall be at least one (1) window or mechanical ventilation to the outside of the bathroom.

13.5.3 Toilets, bathing and toileting appliances shall be equipped for use by residents with physical disabilities, as dictated by such residents' needs.

13.5.4 There shall be at least one (1) toilet of appropriate size for each four (4) residents. Each toilet shall be equipped with a toilet seat and toilet tissue.

13.5.5 There shall be at least one (1) wash basin and one (1) tub or shower for each four residents.

13.5.6 Wash basins with soap and towels shall be available in or immediately adjacent to bathrooms and/or toilet rooms.

13.5.7 Shower and tub areas shall be equipped with substantial hand-grip bars and slip-resistant surfaces.

13.5.8 Bathroom areas shall be equipped with mirrors for personal grooming. Mirrors shall be installed in such a way as to minimize the danger of breakage.

13.6 All group homes shall prepare regular and therapeutic menus. A copy of a recent diet manual shall be available for planning menus.

13.7 A minimum of three (3) meals shall be served in each twenty-four (24) hour period. There shall not be more than a fourteen (14) hour span between the evening meal and breakfast.

13.8 The food served shall be suitably prepared and of sufficient quality and quantity to meet the nutritional needs of the residents.

13.9 Special diets shall be served on the written prescription of the physician.

13.10 A registered dietitian shall plan, review, revise and document menus with resident input.

13.11 Menus showing food actually served shall be kept on file for at least one (1) month.

13.12 A three (3) day supply of food for emergency feeding shall be kept on the premises.

13.13 There shall be refrigeration for perishable foods in the group home. There shall be at least one (1) refrigerator and one (1) freezing unit in proper working order and capable of maintaining frozen foods in the frozen state and refrigerated foods at 41º F. or below.

13.14 Food returned from individual plates shall not be used in preparation of other food dishes or served again.

13.15 There shall be at least one (1) four (4) burner range and one (1) oven (or combination thereof) that is in proper working order.

13.16 There shall be at least one (1) sanitary trash or garbage receptacle.

13.17 There shall be adequate cleaning and disinfecting agents and supplies.

13.18 There shall be separate areas of storage for:

13.18.1 Food items;

13.18.2 Cleaning agents, disinfectants and polishes;

13.18.3 Poisons, chemicals and pesticides; and

13.18.4 Eating, serving and cooking utensils.

13.19 All containers of poisonous and toxic materials kept in a group home shall be prominently and distinctly marked or labeled for easy identification as to contents and shall be used only in such manner and under such conditions as will not contaminate food or constitute a hazard to the residents and staff. All poisonous or toxic materials shall be locked in secure storage spaces.

13.20 All outside doors and windows shall have screens if used for ventilation.

13.21 There shall be a dishwasher or facilities for performing a wash, rinse, and a final sanitizing rinse.

13.22 The kitchen shall be equipped with at least one (1) operable window or exhaust system for removal of smoke, odors and fumes.

13.23 There shall be walls and floors that are cleanable and counters that are both cleanable and impervious to water.

13.24 Every part of the building shall be kept free of offensive odors. Floors, walls, ceilings, and other surfaces shall be kept clean and in good repair.

13.25 Written policies that outline maintenance, electrical maintenance, cleaning procedures, storage of cleaning material, pesticides and other potentially toxic materials shall be prepared and followed.

13.26 There shall be a minimum of two (2) sets of towels, wash cloths, sheets and pillowcases per resident that shall be changed at least weekly, or more often if soiled.

13.27 Laundry should not be done in the kitchen area.

13.28 Exterminator services shall be required when there is evidence of any infestation.

**History**
- *25 DE Reg. 764 (02/01/22)*
- *14 DE Reg. 1360 (06/01/11)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *6 DE Reg. 323 (09/01/02)*
- *6 DE Reg. 654 (11/01/02)*
- *25 DE Reg. 764 (02/01/22)*

##### **16 Del. Admin. Code § 3305-14.0** Safety {#sec-3305-14.0 omnilex-key=us-de-regs-official--title-16--3305-14.0}

14.1 Fire safety in group homes shall comply with the adopted rules and regulations of the State Fire Prevention Commission. All applications for the license or renewal of a license shall include, with the application, a letter certifying compliance by the Fire Marshal having jurisdiction. Notification of non-compliance with the rules and regulations of the State Fire Prevention Commission shall be grounds for revocation of a license.

14.2 The group home shall have a minimum of two (2) doors to the outside and windows that can be opened.

14.3 The group home shall have an adequate number of UL (Underwriter's Laboratory) approved smoke detectors in working order:

14.3.1 In a single level group home, a minimum of one (1) smoke detector placed between the bedroom area and the remainder of the group home.

14.3.2 In a multistory group home, a minimum of one (1) smoke detector on each level. On levels that have bedrooms, the detector shall be placed between the bedroom area and the remainder of the group home.

14.4 There shall be two (2) five (5) pound ABC Fire Extinguishers that are readily accessible and visible in the group home. Extinguishers are to be checked annually.

14.5 The group home shall have a written posted evacuation plan with specific responsibilities of each resident and staff member identified in case of fire or emergencies. Residents and staff shall be trained in executing the evacuation plan. Sufficient staff will be present to ensure timely resident evacuation in the event of an emergency.

14.6 Evacuation drills shall be held quarterly for each shift of group home personnel. Drills shall be held on different days of the week. Drills shall be held at different times of the day, including times when residents are asleep.

14.7 The service provider shall prohibit firearms, and other dangerous weapons within the buildings or on the grounds of the group home.

14.8 Emergency telephone numbers, including telephone numbers for fire, police, physicians, psychiatrists, poison control, crisis intervention services, and ambulance shall be conspicuously posted adjacent to the telephones.

14.9 Glass shower doors shall be marked for safety.

14.10 Smoking shall be limited to designated smoking areas.

14.11 Stairways, ramps, and open-sided approaches shall have adequate lighting and handrails for safety. Non-skid surfaces shall be used when slippery surfaces present a hazard.

14.12 All stairways and hallways shall be kept free and clear of obstructions at all times.

14.13 Floors, walls, ceilings, and other surfaces shall be kept clean and in good repair. Floor surfaces shall not be slippery. If rugs are used, they should be free of such hazards as curled edges, rips, and other irregularities that have a potential for tripping residents.

**History**
- *25 DE Reg. 764 (02/01/22)*
- *14 DE Reg. 1360 (06/01/11)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *6 DE Reg. 323 (09/01/02)*
- *6 DE Reg. 654 (11/01/02)*
- *25 DE Reg. 764 (02/01/22)*

##### **16 Del. Admin. Code § 3305-15.0** Infection Prevention and Control Program {#sec-3305-15.0 omnilex-key=us-de-regs-official--title-16--3305-15.0}

15.1 The group home shall establish and implement an infection prevention and control program which shall be based upon Centers for Disease Control and Prevention and other nationally recognized infection prevention and control guidelines.

15.1.1 The infection prevention and control program must cover all services and all areas of the group home, including provision of the appropriate personal protective equipment for all patients/residents, staff and visitors.

15.2 The individual designated to lead the group home’s infection prevention and control program must develop and implement a comprehensive plan that includes actions to prevent, identify, and manage infections and communicable diseases. The plan must include mechanisms that result in immediate action to take preventive or corrective measures that improve the group home’s infection control outcomes.

15.3 All group home staff shall receive orientation at the time of employment and annual in-service education regarding the infection prevention and control program.

15.4 Specific Requirements for COVID-19

15.4.1 Before their start date, all new staff, vendors and volunteers must be tested for COVID-19 in accordance with Division of Public Health guidance.

15.4.2 All staff, vendors and volunteers must be tested for COVID-19 in a manner consistent with Division of Public Health guidance.

15.4.3 The group home must follow recommendations of the Centers for Disease Control and Prevention and the Division of Public Health regarding the provision of care or services to patients/residents by staff, vendor or volunteer found to be positive for COVID-19 in an infectious stage.

15.5 The group home shall amend their policies and procedures to include:

15.5.1 Work exclusion and return to work protocols for staff tested positive for COVID-19;

15.5.2 Staff refusals to participate in COVID-19 testing;

15.5.3 Staff refusals to authorize release of testing results or vaccination status to the licensee;

15.5.4 Procedures to obtain staff authorizations for release of laboratory test results to the group home to inform infection control and prevention strategies; and

15.5.5 Plans to address staffing shortages and licensee demands should a COVID-19 outbreak occur.

**History**
- *25 DE Reg. 764 (02/01/22)*
- *14 DE Reg. 1360 (06/01/11)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *6 DE Reg. 323 (09/01/02)*
- *6 DE Reg. 654 (11/01/02)*
- *25 DE Reg. 764 (02/01/22)*

##### **16 Del. Admin. Code § 3305-16.0** Noncompliance {#sec-3305-16.0 omnilex-key=us-de-regs-official--title-16--3305-16.0}

16.1 Upon receipt of written notice of a violation of these regulations, the service provider shall submit a written plan of action to correct deficiencies cited within ten (10) days or such other time period as may be required by the Department. The plan of action shall address the corrective actions to be taken and include all measures to prevent their recurrence.

16.2 The Department may impose civil money penalties and/or other enforcement remedies in accordance with the procedures outlined in 16 Del.C., Ch. 11, Subchapter I, Licensing by the State.

16.3 The Department may suspend or revoke a license, or refuse to renew it, in accordance with 16 Del.C., Ch. 11, Subchapter I, Licensing by the State.

**History**
- *25 DE Reg. 764 (02/01/22)*
- *14 DE Reg. 1360 (06/01/11)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *6 DE Reg. 323 (09/01/02)*
- *6 DE Reg. 654 (11/01/02)*
- *25 DE Reg. 764 (02/01/22)*

##### **16 Del. Admin. Code § 3305-17.0** Waiver of Standards {#sec-3305-17.0 omnilex-key=us-de-regs-official--title-16--3305-17.0}

Waivers may be granted by the Division of Health Care Quality for good cause.

**History**
- *25 DE Reg. 764 (02/01/22)*
- *14 DE Reg. 1360 (06/01/11)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *6 DE Reg. 323 (09/01/02)*
- *6 DE Reg. 654 (11/01/02)*
- *25 DE Reg. 764 (02/01/22)*

##### **16 Del. Admin. Code § 3305-18.0** Severability {#sec-3305-18.0 omnilex-key=us-de-regs-official--title-16--3305-18.0}

Should any section, sentence, clause or phrase of these regulations be legally declared unconstitutional or invalid for any reason, the remainder of the regulations shall not be affected.

**History**
- *25 DE Reg. 764 (02/01/22)*
- *14 DE Reg. 1360 (06/01/11)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *25 DE Reg. 764 (02/01/22)*
- *6 DE Reg. 323 (09/01/02)*
- *6 DE Reg. 654 (11/01/02)*
- *25 DE Reg. 764 (02/01/22)*

#### **3310** Neighborhood Homes for Individuals with Intellectual and/or Developmental Disabilities

##### **16 Del. Admin. Code § 3310-1.0** Purpose {#sec-3310-1.0 omnilex-key=us-de-regs-official--title-16--3310-1.0}

To promote the health, safety and well-being of all individuals living in neighborhood homes and to ensure that the providers are held accountable for services provided. In addition to these regulations, providers must comply with the requirements of Division of Developmental Disabilities Services (DDDS).

**History**
- *25 DE Reg. 765 (02/01/22)*
- *25 DE Reg. 765 (02/01/22)*
- *25 DE Reg. 765 (02/01/22)*
- *25 DE Reg. 765 (02/01/22)*
- *7 DE Reg. 505 (10/01/03)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 1477 (04/01/12)*
- *21 DE Reg. 229 (09/01/17)*
- *25 DE Reg, 765 (02/01/22)*

##### **16 Del. Admin. Code § 3310-2.0** Definitions {#sec-3310-2.0 omnilex-key=us-de-regs-official--title-16--3310-2.0}

"Abuse" means the term as defined in 16 Del.C. Ch. 11.

"Authorized Representative" means the person, on behalf of an individual without decision-making capacity, who has the highest priority to act for the individual under law, and who has the authority to make decisions on behalf of the individual. The individual's authorized representative could be a person designated by an individual under an advance health-care directive, an agent under a medical durable power of attorney for health-care decisions or financial decisions, a guardian of the person appointed pursuant to 12 Del.C. Chs. 39 and 39A, in accordance with the authority granted by the appointing court, a surrogate appointed under 16 Del.C. Ch. 25, a person designated by an individual pursuant to 16 Del.C. Ch. 94A, or an individual who is otherwise authorized under applicable law to make the decisions on the individual's behalf, if the individual lacks decision-making capacity.

"Aversive Interventions" means those interventions intended to inflict pain, discomfort and/or social humiliation or any intervention as perceived by the individual to inflict pain, discomfort or social humiliation in order to reduce behavior. Examples of aversive interventions include, but are not limited to, electric skin shock, liquid spray to one's face and strong, non-preferred taste applied to the mouth. (National Association of State Directors of Developmental Disabilities Services (NASDDDS) Research Committee-11/11/2014)

"Choice" means the process by which people make selections from an array of options.

"DDDS" means the Division of Developmental Disabilities Services.

"Department" means the Department of Health and Social Services.

“DHCQ” means the Division of Health Care Quality.

"Financial Exploitation" means the term as defined in 16 Del.C. Chapter 11.

"Incident" means an unexpected and usually unpleasant occurrence that interrupts normal procedure or functioning.

"Individual" means a person living in a neighborhood home in the community who receives authorized services and/or supports through the DDDS.

"Mistreatment" means the term as defined in 16 Del.C. Chapter 11.

"Neglect" means the term as defined in 16 Del.C. Chapter 11.

"Neighborhood Home" means a residence for no more than five (5) individuals that is fully integrated in the community, not on the grounds of an institution, has shared common living areas and is where the individual chooses to live. These homes offer 24 hour supports to individuals with intellectual and/or developmental disabilities.

"Person Centered Plan" means the Life Span Plan or other plan approved by DDDS. This plan includes the following elements: people chosen by the individual; cultural considerations; plain language; strategies for solving disagreements; informed choices to the individual regarding services and supports that the individual receives and from whom; and a method to request updates.

"Provider" means an entity that has been authorized and approved in accordance with the standards of DDDS to provide services to meet the specialized needs of individuals' with intellectual and developmental disabilities.

"Reportable Incident" means an occurrence, event or suspicion of same which must be reported immediately to the DDDS and within 8 hours to the DHCQ.

"Rights Complaint" means an allegation that an individual's rights have been violated.

"Safety" means the absence of recognizable hazards in the design, construction and maintenance of any component of the physical environment including equipment and the establishment of procedures to evaluate and to reduce risks of physical harm.

"Sanitation" means the promotion of hygiene and prevention of disease by the maintenance of uncontaminated conditions.

"Support" means those methods designed to help an individual achieve a meaningful life and to function to his/her fullest capacity.

**History**
- *25 DE Reg. 765 (02/01/22)*
- *25 DE Reg. 765 (02/01/22)*
- *25 DE Reg. 765 (02/01/22)*
- *25 DE Reg. 765 (02/01/22)*
- *7 DE Reg. 505 (10/01/03)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 1477 (04/01/12)*
- *21 DE Reg. 229 (09/01/17)*
- *25 DE Reg, 765 (02/01/22)*

##### **16 Del. Admin. Code § 3310-3.0** Licensing and General Requirements {#sec-3310-3.0 omnilex-key=us-de-regs-official--title-16--3310-3.0}

3.1 No person shall establish, conduct or maintain in this State any neighborhood home without first obtaining a license from the Department.

3.1.1 Issuance of Licenses

3.1.1.1 Initial License

3.1.1.1.1 An initial license approval will be granted to those applicants who meet the requirements for licensure.

3.1.1.1.2 Once an initial license approval has been issued the applicant may accept residents.

3.1.1.1.3 An initial license shall be issued when the first resident moves in and shall be for a term of six (6) months, during which a follow-up inspection will be conducted.

3.1.1.1.3.1 If the applicant meets the licensing requirement at the end of the six (6) month period, an annual license for the remainder of the licensure year will be issued.

3.1.1.1.3.2 If the applicant does not meet the requirements but shows the ability to meet the requirements a provisional licensed may be issued for a period of 90 days pending the implementation of corrective actions.

3.1.1.2 Provisional License:

3.1.1.2.1 A provisional license may be granted for a period of 90 days to a neighborhood home that, after inspection by the Department, is not in substantial compliance with these rules and regulations but has demonstrated the ability and willingness to comply within the 90-day period.

3.1.1.2.2 The Department shall designate the conditions and the time period under which a provisional license is issued.

3.1.1.2.3 A provisional license may not be renewed.

3.1.1.2.4 A license will not be granted pursuant to subsection 3.1.1.2 after the provisional licensure period to any neighborhood home that is not in substantial compliance with these rules and regulations.

3.1.1.3 Annual License:

3.1.1.3.1 A license shall be granted, for a period of one year (12 months), to all neighborhood homes which are and remain in substantial compliance with these rules and regulations.

3.1.1.3.2 A license shall be effective for a twelve-month period following date of issue and shall expire one year following such date, unless it is: modified to a provisional license, suspended, revoked, or surrendered prior to the expiration date.

3.1.1.3.3 All applications for renewal of licenses shall be filed with the Department at least 30 days prior to expiration.

3.1.1.3.4 A license will not be issued to a neighborhood home which is not in substantial compliance with these regulations and/or whose deficient practices present an immediate threat to the health and safety of its residents.

3.1.2 Suspension or Revocation of Licenses

3.1.2.1 The Department may suspend or revoke a license issued under this chapter for good cause, including but not limited to the following:

3.1.2.1.1 Violation of any of the provisions of these rules and regulations or 16 Del.C. Ch. 11.

3.1.2.1.2 Deficiencies which present a threat to the health and safety of residents.

3.1.2.1.3 Permitting, aiding, or abetting the commission of any illegal act in the neighborhood home.

3.1.2.1.4 Conduct or practices which the Department determines pose a serious threat to the health and safety of a resident or residents.

3.1.2.1.5 Refusal to allow the Department access to the neighborhood home to conduct surveys/investigations as deemed necessary by the Department.

3.1.2.2 Before any license issued under this chapter is suspended or revoked, the Department shall give 10 calendar days written notice to the holder of the license, during which the holder may appeal for a hearing before the Secretary of the Department or her/his designee.

3.1.2.3 The holder of the license may, within such 10-day period, give written notice of the desire to have a hearing.

3.1.2.3.1 The due process protections of notice and opportunity to be heard shall be provided to facilities and the hearing process shall be consistent with the Administrative Procedures Act, 29 Del.C. Ch. 101.

3.1.3 Fees

3.1.3.1 Fees shall be in accordance with 16 Del.C. Ch. 11.

3.1.4 A license is not transferable from provider to another or from one location to another.

3.1.5 A new license shall be required in the event of a change in the neighborhood home management company, building owner or controlling person.

3.1.6 The license shall be readily available in the neighborhood home for which it was issued.

3.2 Inspection

3.2.1 Every neighborhood home for which a license has been issued under this chapter shall be inspected at least annually.

3.3 Application Process

3.3.1 All persons or entities applying for a license shall request a licensure application from the Department.

3.3.2 The issuance of an application form is in no way a guarantee that the completed application will be accepted or that a license will be issued by the Department.

3.3.3 Providers applying for an initial license, must submit:

3.3.3.1 Evidence of a satisfactory compliance history, as appropriate, during the preceding five years.

3.3.3.2 A list of all facilities managed, owned or controlled by the applicant or associated entity in any jurisdiction during the preceding five years.

3.3.3.3 Financial information as required by the Department.

3.3.3.3.1 Financial information disclosed to the Department shall not be subject to Freedom of Information Act requests.

3.4 Separate licenses are required for separate homes maintained in separate locations, regardless of their proximity, even though operated by the same provider.

3.5 All required records maintained by the Neighborhood Home shall be open to inspection by the authorized representatives of the DHCQ and DDDS.

3.6 The term "neighborhood home" shall not be used as part of the name of any program in this State unless the home is licensed under these regulations.

3.7 No neighborhood home provider shall adopt rules that conflict with these regulations.

3.8 The Department shall be notified in writing of any changes in the ownership or management of a neighborhood home.

3.9 Each provider shall provide a complete statement listing all charges for services, materials and equipment that shall, or may be, furnished to the individual during the period of residency as part of the admission agreement to all individuals and authorized representatives.

3.10 Each provider shall provide a written statement at the time of admission that includes the refund and prepayment policy; and clarifies responsibility in the event of a retroactive denial in the case of a third party payment.

3.11 Each provider shall cooperate fully with the Medicaid Fraud Control Unit and the state protection and advocacy agency, as defined in 16 Del.C. §1102(7), in fulfilling functions authorized by 16 Del.C. Ch. 11.

**History**
- *25 DE Reg. 765 (02/01/22)*
- *25 DE Reg. 765 (02/01/22)*
- *25 DE Reg. 765 (02/01/22)*
- *25 DE Reg. 765 (02/01/22)*
- *7 DE Reg. 505 (10/01/03)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 1477 (04/01/12)*
- *21 DE Reg. 229 (09/01/17)*
- *25 DE Reg, 765 (02/01/22)*

##### **16 Del. Admin. Code § 3310-4.0** Policies and Procedures {#sec-3310-4.0 omnilex-key=us-de-regs-official--title-16--3310-4.0}

4.1 The provider shall maintain and comply with a written policy and procedure manual.

4.1.1 The manual must be updated as necessary to comply with changes in state and/or federal laws and regulations.

4.1.2 The manual must be reviewed at least annually.

4.1.3 Staff must be notified promptly of changes and provided necessary education.

4.2 The provider shall establish written policies and procedures regarding:

4.2.1 Individuals owning, renting, or occupying the premises:

4.2.1.1 Under a legally enforceable agreement have the same protections from eviction that other tenants have under the Delaware Landlord Tenant Code 25 Del.C. Ch. 53.

4.2.1.2 Are protected under Delaware Administrative Code 3102 Long Term Care Transfer, Discharge and Readmission Procedures.

4.2.2 Behavior support that uses person-centered positive behavior support techniques that are consistent with the DDDS policies/standards and that are monitored by DDDS.

4.2.3 The utilization of reportable incident data to track trends in and help prevent further incidents.

4.2.4 The system for reporting and processing of reportable incidents.

4.2.5 Open communication with persons of the community in which the neighborhood home is located in order to facilitate the individual's community integration.

4.2.6 Criminal background check and drug testing laws as required under 16 Del.C. Ch. 11.

4.2.7 The implementation and documentation of the person-centered plan.

4.2.8 Employment/Personnel which shall include:

4.2.8.1 Qualifications, responsibilities and requirements for each job classification;

4.2.8.2 Pre-employment requirements;

4.2.8.3 Position descriptions;

4.2.8.4 Orientation for all employees and contractors including any guidelines for specialized training;

4.2.8.5 Inservice education policy; and

4.2.8.6 Annual performance review and competency testing.

4.2.9 The rights of individuals and individual rights complaints.

4.2.10 The safeguarding of the individuals' funds while still allowing access to the individuals' funds at all times.

4.2.11 Control of the exposure of individuals and staff to persons with communicable diseases.

4.2.12 Infection prevention and control.

4.2.13 Limited lay administration of medication (LLAM).

4.2.14 Maintenance (including electrical maintenance) and cleaning procedures, storage of cleaning materials and/or pesticides and other toxic materials.

4.2.15 The prohibition of firearms on the premises of the neighborhood home.

**History**
- *25 DE Reg. 765 (02/01/22)*
- *25 DE Reg. 765 (02/01/22)*
- *25 DE Reg. 765 (02/01/22)*
- *25 DE Reg. 765 (02/01/22)*
- *7 DE Reg. 505 (10/01/03)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 1477 (04/01/12)*
- *21 DE Reg. 229 (09/01/17)*
- *25 DE Reg, 765 (02/01/22)*

##### **16 Del. Admin. Code § 3310-5.0** Environment {#sec-3310-5.0 omnilex-key=us-de-regs-official--title-16--3310-5.0}

5.1 Site Provisions

5.1.1 Each neighborhood home shall be located on a site which is considered suitable by the Department.

5.1.2 The site must be safe, easily drained, must be suitable for disposal of sewage and furnishing a potable water supply.

5.1.3 The exterior of the site shall be free from hazards and also from the accumulation of waste materials, obsolete and unnecessary articles, tin cans, rubbish, and other litter.

5.2 The neighborhood home must have a safe and sanitary environment, properly constructed, equipped, and maintained to protect the health and safety of residents.

5.3 The neighborhood home shall comply with all local and state building codes and ordinances as pertain to this occupancy.

5.4 Physical Plant

5.4.1 All construction - new, renovations, or remodeling - must conform to the local building codes, current at the time of construction.

5.4.2 When a neighborhood home plans to construct or extensively remodel a licensed home or convert a building to a licensed home, it shall submit one copy of properly prepared plans and specifications for the entire home to the Department.

5.4.2.1 An approval, in writing, shall be obtained before such work is begun.

5.4.2.2 All completed construction, extensive remodeling or conversions shall remain in accordance with the plans and specifications, as approved by the Department.

5.4.2.3 The Department must visit the site upon completion of the work to ensure that the work was completed according to plans submitted.

5.4.3 Windows

5.4.3.1 Window space shall not be less than one tenth (1/10) of the floor space.

5.4.3.1.1 Up to 25% reduction may be allowed when approved mechanical ventilation is utilized in multi-bed rooms.

5.4.3.2 All windows in rooms to be used by individuals are to be constructed to eliminate drafts and to provide adequate light and ventilation.

5.4.3.3 All windows designed to open and shut must be functional.

5.4.4 The building shall be constructed and maintained to prevent the entrance, and control the existence, of rodents and insects.

5.4.4.1 All exterior openings shall be effectively screened.

5.4.4.2 Screen doors shall open outward and shall be equipped with self-closing devices.

5.4.4.3 All screening shall have at least 16 mesh per inch.

5.4.5 Individual bedrooms shall open directly into a corridor.

5.4.6 The physical dimensions of the home will provide, as a minimum, 150 square feet of common living space for the first occupant and 100 square feet of living space for each additional occupant.

5.4.7 Neighborhood homes with below grade accommodations must have a direct means of egress to the outside from that level.

5.4.8 The roof, exterior walls, doors, skylights and windows shall be weather tight and watertight and shall be kept in sound condition and good repair.

5.5 Water supply and sewage disposal

5.5.1 Non-public water systems must be approved by the Department.

5.5.1.1 Providers must sample non-public water annually and have it tested by the Department.

5.5.1.1.1 A copy of all water testing results must be kept on site at the neighborhood home.

5.5.2 Non-public sewage disposal systems must be approved by the Department of Natural Resources and Environmental Control.

5.5.3 The water system must supply adequate hot and cold water, under pressure, at all times.

5.5.4 The plumbing shall meet the requirements of all municipal or county codes. Where there are no local codes, the provisions of the Department Sanitary Plumbing Code shall prevail.

5.5.5 Hot water at shower, bathing and hand washing facilities shall not exceed 115°F (46°C).

5.6 A licensee must ensure that the home's premises and equipment accessible to or used by residents are free from any danger to their health, safety and well-being.

5.7 Electric shall meet all municipal, county and State requirements and laws.

5.8 Each room and access way shall be suitably lighted at all times for maximum safety, comfort, sanitation and efficiency of operation particularly in areas that present safety hazards. Careful attention shall be given to avoid glare.

5.9 Safety equipment

5.9.1 Stairways shall have non-slip surfaces and sturdy handrails to prevent slipping. Stairways over six (6) feet in width shall have handrails on both sides.

5.9.2 Working electric switches shall be located at the top and the bottom of stairways.

5.9.3 Hallways shall be equipped with working night-lights.

5.9.4 Floor surfaces shall be durable, yet non-abrasive and slip-resistant. Floor surfaces shall be kept in good repair. Area rugs on hard finished floors shall have a non-skid backing. Carpeting shall be maintained in a clean condition.

5.9.5 All interior doors in areas used by individuals shall be capable of being opened from either side at all times.

5.9.6 Cameras or monitoring devices are not permitted in individual bedrooms or bathrooms unless written permission by individual(s) or authorized representative(s) is on file.

5.10 Bedrooms

5.10.1 Each bedroom shall be well-ventilated.

5.10.2 Each bedroom shall be an outside room with at least one (1) window opening directly to the outside. The window sill shall be at least three (3) feet above the floor and above grade.

5.10.3 A one (1) person bedroom shall be at least 100 square feet.

5.10.4 Multi-bed bedrooms shall:

5.10.4.1 Provide at least eighty (80) square feet of floor space per person.

5.10.4.2 Be adequately spaced for comfort.

5.10.4.3 Have the beds spaced at least three (3) feet apart. Bunk beds are prohibited.

5.10.5 The ceiling height shall be not less than seven (7) feet from the floor on average. Areas where the height of the ceiling is less than five (5) feet shall not be counted in the determination of the room size.

5.10.6 Walls must extend from the floor to the ceiling.

5.10.7 Doors must be closable and lockable by the individual with only appropriate staff having keys to the doors.

5.10.8 Each bedroom must have adequate electrical outlets which are conveniently located.

5.10.9 At least one (1) light fixture shall be switched at the entrance to each bedroom.

5.10.10 Walls shall be cleanable.

5.10.11 Each bedroom shall ensure adequate privacy.

5.10.12 No more than two (2) individuals may share a bedroom.

5.10.13 Individuals may furnish and decorate their own bedrooms.

5.10.14 Mattresses shall be covered or protected with non-porous material.

5.10.15 Each bedroom shall provide storage space for clothing and storage space for personal items to include, minimally, closet space.

5.10.16 Bedrooms shall contain space, as needed, for bedside assistance and to accommodate the use and storage of mobility devices and prosthetic equipment.

5.11 Bathrooms

5.11.1 Floor and wall surfaces shall be constructed and maintained to be impervious to water and to permit the floor and walls to be easily kept in a clean condition.

5.11.2 At least one (1) window or mechanical ventilation to the outside shall be provided.

5.11.3 Floor surfaces shall be durable, yet non-abrasive and slip-resistant. Floor surfaces shall be kept in good repair.

5.11.4 There shall be at least one (1) bathtub or shower for every four (4) individuals.

5.11.4.1 Each bathtub or shower shall be in an individual room or enclosure which provides private space for bathing, drying and dressing.

5.11.4.2 Each bathtub or shower shall be equipped with substantial grab bars and slip-resistant surfaces.

5.11.5 There shall be at least one (1) toilet of appropriate size for each four (4) individuals which shall be located on the same level as the individuals' bedrooms.

5.11.5.1 When more than one (1) toilet is located in the same room, provisions for private use shall be made.

5.11.5.2 Each toilet shall be equipped with a substantial grab bar.

5.11.5.3 Each toilet shall be equipped with a toilet seat and toilet tissue.

5.11.6 There shall be at least one (1) hand washing sink for every four (4) individuals which shall be located on the same level as the individual's bedrooms.

5.11.6.1 The hand washing sink shall have hot and cold water.

5.11.6.2 Hand washing sinks shall be available in or immediately adjacent to bathrooms and/or toilet rooms.

5.11.7 Mirrors shall be furnished in bathrooms, including mirrors that are accessible by individuals who use wheelchairs.

5.12 Kitchen

5.12.1 Floor, wall and counter surfaces shall be constructed and maintained to be impervious to water (to the level of splash) and to permit the floor and walls to be easily kept in a clean condition.

5.12.2 There shall be:

5.12.2.1 At least one (1) refrigerator and one (1) freezing unit, in proper working order and capable of maintaining frozen foods in the frozen state and refrigerated foods at 41 degrees F. or below, as determined in the warmest part of the refrigerator.

5.12.2.1.1 Each refrigerator shall be equipped with a refrigerator thermometer.

5.12.2.2 At least one (1) four-burner range and one (1) oven (or combination thereof) which is in proper working order.

5.12.2.3 A dishwasher that has a sanitizing cycle or the home must use a dishwasher detergent with bleach.

5.12.2.4 At least one (1) clean trash receptacle.

5.12.2.5 At least one (1) operable window or suitable exhaust system for removal of smoke, odors and fumes.

5.12.2.6 Adequate cleaning/disinfecting agents and supplies.

5.12.2.7 Storage areas with separate storage for:

5.12.2.7.1 Food, which must be stored off of the floor.

5.12.2.7.1.1 Dry or staple food items shall be stored at least six (6) inches above the floor in a ventilated room that is not subject to waste water back flow or to contamination by condensation or leakage.

5.12.2.7.2 Cleaning agents, disinfectants and polishes.

5.12.2.7.3 Poisons, pesticides or other toxic chemicals which must be stored in locked cabinets/storage areas.

5.12.2.7.3.1 Material Safety Data Sheets (MSDS) must be available for any poisons, pesticides or toxic chemicals stored on-site.

5.12.2.7.4 Eating and serving utensils, pots, pans and cooking utensils which must be stored off of the floor.

5.12.3 All food items shall be stored in closed or sealed containers or wrapping.

5.12.4 Food storage areas shall be free of food particles, dust and dirt.

5.12.5 Food preparation areas, utensils and appliances shall be cleaned following each meal prepared.

5.12.6 Opened foods that are to be stored shall immediately be dated with the date that the foods were opened.

5.12.7 Prepared and leftover foods requiring refrigeration must be kept for no more than three (3) days.

5.13 Dining and dayroom area

5.13.1 There shall be provided one (1) or more areas that are adequate in size and furnished for resident dining, recreational and social activities.

5.13.2 The furniture shall be of such condition so as not to pose a safety hazard and arranged and located as to provide convenient access to the individuals.

5.13.3 When a multi-purpose room is used, it shall have sufficient space to accommodate activities in order to prevent interference of one (1) activity with another.

5.14 Sanitation and housekeeping

5.14.1 All rooms and every part of the building shall be kept clean, orderly, in good repair and free of offensive odors.

5.14.2 Waste material, obsolete and unnecessary articles, tin cans, rubbish and other litter shall not be permitted to accumulate in the home.

5.14.3 Sharps shall be stored in sanitary containers and disposed of in a sanitary manner.

5.14.4 When a separate sink is not provided for janitorial or laundry duties, the sink shall be sanitized with bleach after each use.

5.14.5 No laundry may be done in the food service area during the preparation or serving of food.

5.14.6 Laundry

5.14.6.1 Bed linens and towels must be changed at least weekly or more often as necessary.

5.14.6.2 If linen chutes are used, they will maintained in a sanitary condition.

5.14.6.3 If the clothes washing machine is in the kitchen, soiled laundry shall not be taken into the kitchen until it is ready to be washed.

5.14.6.4 The authorized provider will complete laundry for individuals who are incapable of doing so on their own.

5.15 Providers shall ensure a home-like environment for each licensed home. Functional arrangement of rooms, furnishings, and decor shall be compatible with the need for accessibility.

5.16 Furniture and furnishings shall be safe, comfortable, cleanable and in good repair and shall resemble those in homes in the local community, to the extent compatible with individuals' choice and the physical needs of the individuals living in the home. To the extent possible, personal furniture shall be chosen by individuals.

5.17 Heating apparatus shall not constitute a burn, smoke or carbon monoxide hazard to individuals served or their support staff.

5.18 Temperature, humidity, ventilation, and light in all living and sleeping quarters shall be maintained to provide a comfortable atmosphere.

5.19 Use of security or observational devices shall constitute a restrictive procedure and require consent and review by the human rights committee. The need for such devices shall be documented in the individual's behavior support plan.

5.20 Basement space may be used for activities for people in the home if there is a minimum of two (2) fire exits.

**History**
- *25 DE Reg. 765 (02/01/22)*
- *25 DE Reg. 765 (02/01/22)*
- *25 DE Reg. 765 (02/01/22)*
- *25 DE Reg. 765 (02/01/22)*
- *7 DE Reg. 505 (10/01/03)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 1477 (04/01/12)*
- *21 DE Reg. 229 (09/01/17)*
- *25 DE Reg, 765 (02/01/22)*

##### **16 Del. Admin. Code § 3310-6.0** Records and Reports {#sec-3310-6.0 omnilex-key=us-de-regs-official--title-16--3310-6.0}

6.1 There shall be a separate record maintained on each individual as per DDDS standards.

6.2 There shall be a medication administration record (MAR) including medications, dosages, frequency, route of administration, and initials of the person administering each dose. The record shall include the identity of each person administering medication.

6.3 Confidentiality of individuals' records shall be maintained in accordance with the federal Health Insurance Portability and Accountability Act (HIPAA) and 16 Del.C. §1121(6).

6.4 Records shall be retained for 6 years after discharge. For a minor, records shall be retained for three years after age of majority.

6.5 Incident reporting

6.5.1 All incidents shall be adequately documented. Adequate documentation shall include:

6.5.1.1 The name of the individual(s) involved;

6.5.1.2 The date, time and place of the incident;

6.5.1.3 A detailed description of the incident;

6.5.1.4 A list of other parties involved, including witnesses;

6.5.1.5 Witness statements;

6.5.1.6 The nature of any injuries sustained;

6.5.1.7 individual(s) outcome(s); and

6.5.1.8 Follow-up action:

6.5.1.8.1 Notification of the individual(s) authorized representative(s), attending physician and licensing or law enforcement authorities, when appropriate;

6.5.1.8.2 The corrective action taken immediately for each individual or area impacted;

6.5.1.8.3 How the staff will act to protect individuals in a similar situation;

6.5.1.8.4 What measures will be taken or what systems will be changed to ensure that the incident does not recur;

6.5.1.8.5 How the staff will measure the success of the interventions put in place.

6.6 All reports of incidents, whether or not required to be reported, shall be retained for three years.

6.7 Reportable incidents shall be communicated immediately to the DDDS and within 8 hours to the DHCQ.

6.8 Reportable incidents are as follows:

6.8.1 Abuse as defined in 16 Del.C. §1131, or reasonable suspicion of same.

6.8.1.1 Physical abuse with injury if individual to individual and physical abuse with or without injury if staff to individual or any other person to individual.

6.8.1.2 Any sexual act between staff and an individual and any non-consensual sexual act between individuals or between an individual and any other person such as a visitor.

6.8.1.3 Emotional abuse whether staff to individual, individual to individual or any other person to individual.

6.8.2 Neglect, mistreatment or financial exploitation as defined in 16 Del.C. §1131, or reasonable suspicion of same.

6.8.3 Individual elopement under the following circumstances:

6.8.3.1 An individual's whereabouts on or off the premises is unknown to staff and the individual suffers harm.

6.8.3.2 A cognitively impaired individual's whereabouts are unknown to staff and the individual leaves the neighborhood home premises.

6.8.3.3 An individual cannot be found inside or outside the neighborhood home and the police are summoned.

6.8.4 Significant injuries.

6.8.4.1 Injury from an incident of unknown source in which the initial evaluation supports the conclusion that the injury is suspicious.

6.8.4.1.1 Circumstances which may cause an injury to be suspicious are:

6.8.4.1.1.1 The extent of the injury;

6.8.4.1.1.2 The location of the injury (e.g., the injury is located in an area not generally vulnerable to trauma);

6.8.4.1.1.3 The number of injuries observed at one particular point in time; or

6.8.4.1.1.4 The incidence of injuries over time.

6.8.4.2 Injury which results in medical or dental treatment other than first aid provided in the home.

6.8.4.3 Areas of contusions or bruises caused by staff to a dependent individual during ambulation, transport, transfer or bathing.

6.8.4.4 Significant error or omission in medication/treatment, including drug diversion, which causes the individual discomfort or jeopardizes the individual's health and safety.

6.8.4.5 A burn greater than first degree.

6.8.4.6 Any serious unusual and/or life-threatening injury.

6.8.5 Entrapment which causes the individual injury or immobility of body or limb or which requires assistance from another person for the individual to secure release.

6.8.6 Suicide or attempted suicide.

6.8.7 Poisoning.

6.8.8 Fire within a neighborhood home.

6.8.9 Utility interruption lasting more than eight hours in one or more major service(s) including electricity, water supply, plumbing, heating or air conditioning, fire alarm, sprinkler system or telephones.

6.8.10 Structural damage or unsafe structural conditions.

6.8.11 Water damage which impacts individual health, safety or comfort.

6.8.12 Deaths.

6.9 The authorized provider shall maintain records and reports of fire safety, health, sanitation, and environmental inspections required by local and state laws and regulations.

6.9.1 The provider shall document actions taken to correct deficiencies noted in these reports. Corrective actions shall include:

6.9.1.1 The corrective action taken immediately for each individual or area impacted;

6.9.1.2 How the staff will act to protect individuals in a similar situation;

6.9.1.3 What measures will be taken or what systems will be changed to ensure that the incident does not recur;

6.9.1.4 How the staff will measure the success of the interventions put in place.

**History**
- *25 DE Reg. 765 (02/01/22)*
- *25 DE Reg. 765 (02/01/22)*
- *25 DE Reg. 765 (02/01/22)*
- *25 DE Reg. 765 (02/01/22)*
- *7 DE Reg. 505 (10/01/03)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 1477 (04/01/12)*
- *21 DE Reg. 229 (09/01/17)*
- *25 DE Reg, 765 (02/01/22)*

##### **16 Del. Admin. Code § 3310-7.0** Emergencies and Disasters {#sec-3310-7.0 omnilex-key=us-de-regs-official--title-16--3310-7.0}

7.1 Fire safety in neighborhood homes shall comply with the rules and regulations of the State Fire Prevention Commission or the appropriate local jurisdiction.

7.2 The home shall have a minimum of two means of egress.

7.3 The home shall have an adequate number of UL approved smoke detectors in working order.

7.3.1 In a single level home, a minimum of one smoke detector shall be placed between the bedroom area and the remainder of the home.

7.3.2 In a multi-story home, a minimum of one smoke detector shall be on each level. On levels which have bedrooms, the detector shall be placed between the bedroom area and the remainder of the home.

7.4 There shall be at least one functional two and one-half to five pound ABC fire extinguisher on each floor of living space in the home that is readily accessible, visible and mounted on the wall. Each extinguisher shall be checked annually.

7.5 The service provider shall have written procedures for meeting all emergencies and disasters such as fire, severe weather, and missing individuals; and such procedures shall be communicated to all staff.

7.5.1 The procedures shall assign staff on duty to specific tasks and responsibilities.

7.5.2 The procedures shall contain instructions related to the use of alarm and signal systems. Provisions shall be made to alert individuals living in the home according to their abilities, and these provisions shall be included in the procedures.

7.6 The provider shall maintain an adequate communication system to ensure that on and off-duty personnel and local fire and safety authorities are notified promptly in the event of an emergency or disaster.

7.7 The telephone numbers of the nearest poison control center and the nearest source of emergency medical services shall be posted.

7.8 Provisions shall be made for emergency auxiliary heat and lighting by means of alternate sources of electric power, alternate fuels, and stand-by equipment, or arrangements with neighbors, other agencies or community resources.

7.9 Evacuation Drills

7.9.1 Drills shall be held quarterly and on different days and at different times. Drills are not to be held at night, during individuals' sleep time, nor are they to be held in inclement weather.

7.9.2 The location of egress during these evacuation drills shall be varied, with window evacuation procedures discussed as an alternative, if not practiced.

7.9.3 During drills, individuals shall be evacuated with staff assistance to the designated safe area outside of the home.

7.9.4 As evidenced by evacuation drill reports that are maintained by the neighborhood home, drills shall assure that all individuals and staff are familiar with the evacuation requirements and procedures.

7.9.4.1 Any problems individuals have evacuating a building during a drill shall result in a written plan of specific corrective action(s) to be taken.

**History**
- *25 DE Reg. 765 (02/01/22)*
- *25 DE Reg. 765 (02/01/22)*
- *25 DE Reg. 765 (02/01/22)*
- *25 DE Reg. 765 (02/01/22)*
- *7 DE Reg. 505 (10/01/03)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 1477 (04/01/12)*
- *21 DE Reg. 229 (09/01/17)*
- *25 DE Reg, 765 (02/01/22)*

##### **16 Del. Admin. Code § 3310-8.0** Individual Rights {#sec-3310-8.0 omnilex-key=us-de-regs-official--title-16--3310-8.0}

Neighborhood homes must comply with 16 Del.C. Ch.11, Subchapter II, regarding the rights of the individuals residing in the neighborhood homes.

**History**
- *25 DE Reg. 765 (02/01/22)*
- *25 DE Reg. 765 (02/01/22)*
- *25 DE Reg. 765 (02/01/22)*
- *25 DE Reg. 765 (02/01/22)*
- *7 DE Reg. 505 (10/01/03)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 1477 (04/01/12)*
- *21 DE Reg. 229 (09/01/17)*
- *25 DE Reg, 765 (02/01/22)*

##### **16 Del. Admin. Code § 3310-9.0** Individual Services {#sec-3310-9.0 omnilex-key=us-de-regs-official--title-16--3310-9.0}

9.1 Healthcare

9.1.1 The provider shall ensure that individuals receive needed medical, dental, visual and behavioral care.

9.1.2 Necessary screenings/appointments are scheduled within five (5) business days of receipt of an order.

9.1.3 Providers assist individuals to the carry out all health related orders as determined by the health care professionals.

9.1.4 Each resident shall have a physical/medical examination annually or more frequently as required by a physician or the affiliated social agency/program.

9.1.5 Medications

9.1.5.1 Medications prescribed for residents shall be kept locked in a cabinet or a lock box set aside for that exclusive purpose.

9.1.5.2 Medications requiring refrigeration shall be kept locked in a separate box within the refrigerator.

9.1.5.3 Medications shall be self-administered or distributed directly to the resident from the prescription container in strict accordance with the prescription directions.

9.1.5.3.1 Administration of medications must be in accordance with the requirements in 24 Del.C. Ch.19, §1932.

9.1.5.4 The authorized provider shall ensure that prescription medication is not used by other than the resident for whom the medication was prescribed.

9.1.5.5 Topical (external) medications must be stored separately from oral (internal) medications.

9.1.5.6 Controlled substances must be under a double lock whether stored in a cupboard or refrigerator. A lock on an outside access door can be considered the first lock.

9.1.5.7 Medication must be stored at room temperature (59-86F) unless otherwise indicated by the labeling in a manner that protects the product itself from deterioration or container breakage.

9.1.6 Communicable disease

9.1.6.1 An individual with an active communicable disease must receive prompt medical treatment and supervision.

9.1.6.2 The provider shall assume responsibility for seeing that necessary precautions are taken and that there is a minimum danger of transmission of a communicable disease to any occupant of the home.

9.1.6.3 Minimum requirements for tuberculosis (TB) testing require all occupants to have a base line two step tuberculin skin test.

9.1.6.4 All homes shall have on file evidence of an annual vaccination against influenza for all residents unless refused or medically contraindicated.

9.2 The provider shall provide or assist to arrange for transportation for an individual's appointments.

9.3 Food service

9.3.1 A minimum of three (3) meals shall be available and/or served in each 24 hour period.

9.3.2 There shall not be more than a 14 hour span between the evening and breakfast meals unless suitable nourishment is provided in the interim.

9.3.3 Individuals shall have access to food at all times.

9.3.4 The food served shall be suitably prepared and of sufficient quantity and quality to meet the nutritional needs of the residents.

9.3.5 Special diets shall be served on the written prescription of the resident's physician.

9.3.6 There shall be three day supply of food and water in each home at all times.

**History**
- *25 DE Reg. 765 (02/01/22)*
- *25 DE Reg. 765 (02/01/22)*
- *25 DE Reg. 765 (02/01/22)*
- *25 DE Reg. 765 (02/01/22)*
- *7 DE Reg. 505 (10/01/03)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 1477 (04/01/12)*
- *21 DE Reg. 229 (09/01/17)*
- *25 DE Reg, 765 (02/01/22)*

##### **16 Del. Admin. Code § 3310-10.0** Personnel {#sec-3310-10.0 omnilex-key=us-de-regs-official--title-16--3310-10.0}

10.1 Personnel records shall be kept current and available for each employee, and include the following:

10.1.1 Results of tuberculosis screening.

10.1.2 Documentation of annual influenza vaccination or refusal.

10.1.3 Result of criminal background check.

10.1.4 Result of mandatory drug testing.

10.1.5 Result of Adult Abuse Registry check.

10.1.6 Titles and hours of in-service training.

10.1.7 If applicable, license/certification number and expiration date.

10.2 Each neighborhood home must have at least one (1) staff person on duty at all times when individuals are present in the home.

10.2.1 Staffing must conform to the specific needs of the individuals as recorded on the person-centered plan.

10.3 Each neighborhood home must have at least one (1) staff person, on duty at all times, trained in first aid and CPR.

10.4 Each neighborhood home must have a nurse on-call at all times for consultation.

**History**
- *25 DE Reg. 765 (02/01/22)*
- *25 DE Reg. 765 (02/01/22)*
- *25 DE Reg. 765 (02/01/22)*
- *25 DE Reg. 765 (02/01/22)*
- *7 DE Reg. 505 (10/01/03)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 1477 (04/01/12)*
- *21 DE Reg. 229 (09/01/17)*
- *25 DE Reg, 765 (02/01/22)*

##### **16 Del. Admin. Code § 3310-11.0** Infection Prevention and Control Program {#sec-3310-11.0 omnilex-key=us-de-regs-official--title-16--3310-11.0}

11.1 The provider shall establish an infection prevention and control program which shall be based upon Centers for Disease Control and Prevention and other nationally recognized infection prevention and control guidelines.

11.1.1 The infection prevention and control program must cover all services and all areas of the facility, including provision of the appropriate personal protective equipment for all residents, staff and visitors.

11.2 The individual designated to lead the provider’s infection prevention and control program must develop and implement a comprehensive plan that includes actions to prevent, identify, and manage infections and communicable diseases. The plan must include mechanisms that result in immediate action to take preventive or corrective measures that improve the provider’s infection control outcomes.

11.3 All staff shall receive orientation at the time of employment and annual in-service education regarding the infection prevention and control program.

11.4 Specific Requirements for COVID-19

11.4.1 Before their start date, all new staff, vendors and volunteers must be tested for COVID-19 in accordance with Division of Public Health guidance.

11.4.2 All staff, vendors and volunteers must be tested for COVID-19 in a manner consistent with Division of Public Health guidance.

11.4.3 The provider must follow recommendations of the Centers for Disease Control and Prevention and the Division of Public Health regarding the provision of care or services to residents by staff, vendor or volunteer found to be positive for COVID-19 in an infectious stage.

11.5 The provider shall amend their policies and procedures to include:

11.5.1 Work exclusion and return to work protocols for staff tested positive for COVID-19;

11.5.2 Staff refusals to participate in COVID-19 testing;

11.5.3 Staff refusals to authorize release of testing results or vaccination status to the provider;

11.5.4 Procedures to obtain staff authorizations for release of laboratory test results to the provider to inform infection control and prevention strategies; and

11.5.5 Plans to address staffing shortages and provider demands should a COVID-19 outbreak occur.

**History**
- *25 DE Reg. 765 (02/01/22)*
- *25 DE Reg. 765 (02/01/22)*
- *25 DE Reg. 765 (02/01/22)*
- *25 DE Reg. 765 (02/01/22)*
- *7 DE Reg. 505 (10/01/03)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 1477 (04/01/12)*
- *21 DE Reg. 229 (09/01/17)*
- *25 DE Reg, 765 (02/01/22)*

##### **16 Del. Admin. Code § 3310-12.0** Severability {#sec-3310-12.0 omnilex-key=us-de-regs-official--title-16--3310-12.0}

Should any section, sentence, clause or phrase of these regulations be legally declared unconstitutional or invalid for any reason, the remainder of said regulations shall not be affected thereby.

**History**
- *25 DE Reg. 765 (02/01/22)*
- *25 DE Reg. 765 (02/01/22)*
- *25 DE Reg. 765 (02/01/22)*
- *25 DE Reg. 765 (02/01/22)*
- *7 DE Reg. 505 (10/01/03)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 1477 (04/01/12)*
- *21 DE Reg. 229 (09/01/17)*
- *25 DE Reg, 765 (02/01/22)*

#### **3315** Family Care Homes

##### **16 Del. Admin. Code § 3315-1.0** Purpose {#sec-3315-1.0 omnilex-key=us-de-regs-official--title-16--3315-1.0}

These regulations are developed and promulgated to promote and ensure the health, safety and well-being of all residents of Family Care Homes. These regulations also ensure that Family Care Homes will be responsible and accountable to their residents. The regulations establish the minimal acceptable level of services for residents of Family Care Homes.

**History**
- *25 DE Reg. 766 (02/01/22)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 192 (08/01/11)*
- *18 DE Reg. 569 (01/01/15)*
- *25 DE Reg. 766 (02/01/22)*

##### **16 Del. Admin. Code § 3315-2.0** Definitions {#sec-3315-2.0 omnilex-key=us-de-regs-official--title-16--3315-2.0}

The following words and terms, when used in this regulation, should have the following meaning unless the context clearly indicates otherwise:

"Activities of Daily Living" (ADL) means the tasks for self-care which are performed either independently, with supervision, or with assistance. Activities of daily living include but are not limited to ambulating, transferring, grooming, bathing, dressing, eating and toileting.

"Affiliated Social Agency/Program" means an agency which has entered into an agreement with the Department of Health and Social Services to ensure that the health and welfare needs of the resident are met.

"Case Manager" means an individual from an affiliated social agency/program who works with the residents, the family care provider and others to assist the residents in adjusting to and maintaining themselves in the community. This includes planning, organizing, coordinating and/or advocating so that effective services are provided.

"Department" means the Delaware Department of Health and Social Services.

"Family Care Home" (FCH) means a home (physical structure and necessary equipment) that provides beds and personal care services for 2 or 3 residents who cannot live independently and who need or could benefit from a family living situation. The home provides shelter, housekeeping services, food/meals and personal care for residents.

"Family Care Provider" means a person, the holder of the license, who is responsible for providing direct supervision and care for residents. The family care provider is to provide consumer-driven services which maximize independence through individual choice, enable individuals to continue living active and productive lives and protect those who are vulnerable and at risk.

"Level of Care" means a written determination of the amount of assistance a resident requires in the areas of, activities of daily living, medication, treatments and therapies, mobility, behavior management and supervision. The document will also contain the amount of time a resident can be left unsupervised while the FCH provider is out of the residence.

"Licensed Independent Practitioner" means a physician; a physician's assistant; or a nurse practitioner licensed under 24 Del.C. Chs. 17 or 19.

"Occupant" means any person living in a home on a 24 hour continuing basis, in excess of 48 hours per week, or more than 30 days per year. Included are: residents, family care provider and family care provider family members.

"Physician" means an individual currently licensed as such by 24 Del.C. Ch. 17.

"Resident" means an individual residing in a family care home.

"Supervision" means direct oversight of a function or activity by a responsible person who is not a resident.

**History**
- *25 DE Reg. 766 (02/01/22)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 192 (08/01/11)*
- *18 DE Reg. 569 (01/01/15)*
- *25 DE Reg. 766 (02/01/22)*

##### **16 Del. Admin. Code § 3315-3.0** Licensing Requirements and Procedures {#sec-3315-3.0 omnilex-key=us-de-regs-official--title-16--3315-3.0}

3.1 No person shall establish, conduct or maintain in this State any FCH without first obtaining a license from the Department.

3.1.1 Issuance of Licenses

3.1.1.1 Initial License

3.1.1.1.1 An initial license approval will be granted to those applicants who meet the requirements for licensure.

3.1.1.1.2 Once an initial license approval has been issued the applicant may accept residents.

3.1.1.1.3 An initial license shall be issued when the first resident moves in and shall be for a term of six (6) months, during which a follow-up inspection will be conducted. If the applicant meets the licensing requirement at that time an annual license for the remainder of the licensure year will be issued.

3.1.1.1.4 If the applicant does not meet the requirements but shows the ability to meet the requirements a provisional licensed may be issued for a period of 90 days pending the implementation of the corrective actions.

3.1.1.2 Provisional License:

3.1.1.2.1 A provisional license may be granted for a period of 90 days to an FCH that, after inspection by the Department, is not in substantial compliance with these rules and regulations but has demonstrated the ability and willingness to comply within the 90-day period.

3.1.1.2.2 The Department shall designate the conditions and the time period under which a provisional license is issued.

3.1.1.2.3 A provisional license may not be renewed unless a Plan for Corrective Action has been approved by the Department and implemented by the FCH.

3.1.1.2.4 A license will not be granted pursuant to 3.1.1.2 after the provisional licensure period to any FCH that is not in substantial compliance with these rules and regulations.

3.1.1.3 Annual License:

3.1.1.3.1 A license shall be granted, for a period of one year (12 months), to all FCHs which are and remain in substantial compliance with these rules and regulations.

3.1.1.3.2 A license shall be effective for a twelve-month period following date of issue and shall expire one year following such date, unless it is: modified to a provisional license, suspended, revoked, or surrendered prior to the expiration date.

3.1.1.3.3 FCHs must apply for licensure at least 30 days prior to the expiration date of the license.

3.1.1.3.4 A license will not be issued to an FCH which is not in substantial compliance with these regulations and/or whose deficient practices present an immediate threat to the health and safety of its residents.

3.1.2 Suspension or Revocation of Licenses

3.1.2.1 The Department may suspend or revoke a license issued under this chapter for good cause, including but not limited to the following:

3.1.2.1.1 Violation of any of the provisions of these rules and regulations or 16 Del.C. Ch. 11.

3.1.2.1.2 Deficiencies which present a threat to the health and safety of residents.

3.1.2.1.3 Permitting, aiding, or abetting the commission of any illegal act in the FCH.

3.1.2.1.4 Conduct or practices detrimental to the welfare of the resident.

3.1.2.1.5 Refusal to allow the Department access to the FCH to conduct surveys/investigations as deemed necessary by the Department.

3.1.2.2 Before any license issued under this chapter is suspended or revoked, the Department shall give 10 calendar days written notice to the holder of the license, during which (s)he may appeal for a hearing before the Secretary of the Department or her/his designee.

3.1.2.3 The holder of the license may, within such 10-day period, give written notice of her/his desire to have a hearing. Proceedings in regard to such hearing shall be conducted in accordance with provisions for case decisions as set forth in 29 Del.C. Ch. 101 and in accordance with applicable rules and regulations of the Department.

3.1.3 Fees

3.1.3.1 Fees shall be in accordance with 16 Del.C. Ch. 11.

3.1.4 A license is not transferable from person to person or from one location to another.

3.1.5 The license shall be posted in a conspicuous place on the licensed premises.

3.2 Inspection

3.2.1 Every FCH for which a license has been issued under this chapter shall be periodically inspected by a representative of the Department.

3.3 Application Process

3.3.1 All persons or entities applying for a license shall request a licensure application from the Department.

3.3.2 The issuance of an application form is in no way a guarantee that the completed application will be accepted or that a license will be issued by the Department.

3.3.2 Applicants shall submit, to the Department, the names, ages and relationship to the family care provider of each person living in the home.

3.4 Financial Requirement

3.4.1 Each family care provider shall submit financial documentation to the Department that will be used solely to determine financial capability.

**History**
- *25 DE Reg. 766 (02/01/22)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 192 (08/01/11)*
- *18 DE Reg. 569 (01/01/15)*
- *25 DE Reg. 766 (02/01/22)*

##### **16 Del. Admin. Code § 3315-4.0** General Requirements {#sec-3315-4.0 omnilex-key=us-de-regs-official--title-16--3315-4.0}

4.1 Admission to an FCH shall be limited to residents whose needs can be met with the following services: assistance with activities of daily living where the resident needs moderate, standby or "hands on" assistance; assistance with/and or administration of medications, interventions to manage occasional behaviors and; scheduling of and, if necessary, transportation to scheduled treatments or therapies.

4.2 The holder of the license must be living in the home full-time.

4.3 The FCH must meet and maintain compliance with all applicable federal, state, and local laws and regulations.

4.4 The affiliated social agency/program or a licensed independent practitioner with the placement agency will establish a level of care. The level of care determination shall be made in consultation with the resident’s personal primary care licensed independent practitioner if any, and will include an assessment of the physical and mental status of the resident prior to admission to the FCH and annually thereafter.

4.4.1 A copy of the level of care must be maintained by the licensee.

4.5 When a licensed independent practitioner with the placement agency determines that a resident requires additional medical services, it is the responsibility of the family care provider to ensure that those services are received by the resident.

4.6 All required records maintained by the FCH shall be open to inspection by authorized representatives of the Department and an affiliated social agency/program.

4.7 A resident who is not sponsored by an affiliated social agency/program will arrange with a licensed independent practitioner to establish a level of care. The level of care will include an assessment of the physical and mental status of the resident prior to placement in the FCH and annually thereafter.

4.7.1 A copy of the level of care must be maintained by the licensee.

4.8 An FCH licensed under these regulations shall not admit any person under the age of 18 years as a resident.

4.8.1 The FCH may request a waiver of this provision, through the Department for residents with specific medical or social needs.

4.8.2 If a waiver is granted and a juvenile resident is to be housed on the same floor as an adult resident, the juvenile's affiliated social service agency/program must also give written approval to the FCH and provide a copy to the Department. The affiliated social service agency/program shall also ensure the placement is appropriate given the physical, emotional and medical conditions of the other residents.

4.9 A resident must be provided a bedroom separate from the family care provider and her/his family members.

4.10 The holder of the license must notify the Department at least 30 days before any change in the family care provider or a change in the FCH ownership.

4.11 The family care provider may not leave the FCH when residents are present without delegating care duties to a responsible adult unless the resident’s Level of Care documentation contains an amount of time that the resident can be left unsupervised. In any case, the maximum amount of time the provider can be away is 12 hours.

4.11.1 The name and contact information for the alternate responsible adult must be on file with the Department.

4.12 The family care provider must notify the Department, in advance when possible, of any absence of 1 week or longer.

4.13 Each FCH shall cooperate fully with the state protection and advocacy agency, as defined in 16 Del.C. §1102(7), in fulfilling functions authorized by 16 Del.C. Ch. 11.

4.14 A family care provider that provides services to persons diagnosed as having Alzheimer's disease or other forms of dementia shall receive annual dementia specific training that includes: communicating with persons diagnosed as having Alzheimer's disease or other forms of dementia; the psychological, social, and physical needs of those persons; and safety measures which need to be taken with those persons.

4.15 Family pets must have all necessary yearly updated vaccinations from a veterinarian and there will be no vicious or dangerous animals residing in the home that could pose a risk of harm to a resident.

**History**
- *25 DE Reg. 766 (02/01/22)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 192 (08/01/11)*
- *18 DE Reg. 569 (01/01/15)*
- *25 DE Reg. 766 (02/01/22)*

##### **16 Del. Admin. Code § 3315-5.0** Environment {#sec-3315-5.0 omnilex-key=us-de-regs-official--title-16--3315-5.0}

5.1 Site Provisions

5.1.1 Each FCH shall be located on a site which is considered suitable by the Department.

5.1.2 The site must be safe, easily drained, must be suitable for disposal of sewage and furnishing a potable water supply.

5.1.3 The exterior of the site shall be free from hazards and also from the accumulation of waste materials, obsolete and unnecessary articles, tin cans, rubbish, and other litter.

5.2 The FCH must have a safe and sanitary environment, properly constructed, equipped, and maintained to protect the health and safety of residents.

5.3 The FCH shall comply with all local and state building codes and ordinances as pertain to this occupancy.

5.4 Physical Plant

5.4.1 All construction - new, renovations, or remodeling - must conform to the local building codes, current at the time of construction.

5.4.2 When an FCH plans to construct, renovate or extensively remodel, the holder of the license must submit a copy of properly prepared plans and specifications to the Department for approval.

5.4.2.1 The Department must issue an approval in writing before any work is done.

5.4.2.2 The Department must visit the site upon completion of the work to ensure that the work was completed according to plans submitted.

5.4.3 Windows

5.4.3.1 Window space shall not be less than one tenth (1/10) of the floor space.

5.4.3.1.1 Up to 25% reduction may be allowed when approved mechanical ventilation is utilized in multi-bed rooms.

5.4.3.2 All windows in rooms to be used by residents are to be constructed to eliminate drafts and to provide adequate light and ventilation.

5.4.4 The building shall be constructed and maintained to prevent the entrance, and control the existence, of rodents and insects.

5.4.4.1 All exterior openings shall be effectively screened.

5.4.4.2 Screen doors shall open outward and shall be equipped with self-closing devices.

5.4.4.3 All screening shall have at least 16 mesh per inch.

5.4.5 Resident bedrooms shall open directly into a corridor.

5.4.6 FCHs accommodating residents who regularly require wheelchairs shall be equipped with ramps.

5.4.6.1 Egress ramps must be located at the primary means of egress.

5.4.6.1.1 A secondary means of egress that is independent and remotely located from the primary means of egress must be provided to the outside of the dwelling at street/ground level or open to an exterior balcony.

5.4.6.2 A ramp must be compliant with the standards outlined in Americans with Disabilities Act (ADA).

5.4.7 The physical dimensions of the home will provide, as a minimum, 150 square feet of common living space for the first occupant and 100 square feet of living space for each additional occupant.

5.4.8 FCHs with below grade accommodations must have a direct means of egress to the outside from that level.

5.4.9 The roof, exterior walls, doors, skylights and windows shall be weather tight and watertight and shall be kept in sound condition and good repair.

5.5 Water supply and sewage disposal

5.5.1 Non-public water systems must be approved by the Department.

5.5.2 Non-public sewage disposal systems must be approved by the Department of Natural Resources and Environmental Control.

5.5.3 The water system must supply adequate hot and cold water, under pressure, at all times.

5.5.4 The plumbing shall meet the requirements of all municipal or county codes. Where there are no local codes, the provisions of the Department Sanitary Plumbing Code shall prevail.

5.5.5 Hot water at shower, bathing and hand washing facilities shall not exceed 110°F (43°C).

5.6 A licensee must ensure that the facility’s or program’s premises and equipment accessible to or used by residents are free from any danger to their health, safety and well-being.

5.7 Electric shall meet all municipal, county and State requirements and laws.

5.8 Each room and access way shall be suitably lighted at all times for maximum safety, comfort, sanitation and efficiency of operation particularly in areas that present safety hazards. Careful attention shall be given to avoid glare.

5.9 Safety equipment

5.9.1 Stairways shall have non-slip surfaces and sturdy handrails to prevent slipping. Stairways over six (6) feet in width shall have handrails on both sides.

5.9.2 Working electric switches shall be located at the top and the bottom of stairways.

5.9.3 Hallways shall be equipped with working night-lights.

5.9.4 Floor surfaces shall be durable, yet non-abrasive and slip-resistant. Floor surfaces shall be kept in good repair. Area rugs on hard finished floors shall have a non-skid backing. Carpeting shall be maintained in a clean condition.

5.9.5 All interior doors in areas used by residents shall be capable of being opened from either side at all times.

5.9.6 Cameras or monitoring devices are not permitted in resident bedrooms or bathrooms unless written permission by resident(s), resident guardian(s) is on file.

5.10 Resident bedrooms

5.10.1 Each bedroom shall be well-ventilated.

5.10.2 Each bedroom shall be an outside room with at least one (1) window opening directly to the outside. The window sill shall be at least three (3) feet above the floor and above grade.

5.10.3 A one (1) person bedroom shall be at least seventy (70) square feet.

5.10.4 Multi-person bedrooms shall:

5.10.4.1 Provide at least fifty (50) square feet of floor space per person.

5.10.4.2 Be adequately spaced for comfort.

5.10.4.3 Have the beds spaced at least three (3) feet apart. Bunk beds are prohibited.

5.10.5 The ceiling height shall be not less than seven (7) feet from the floor on average. Areas where the height of the ceiling is less than five (5) feet shall not be counted in the determination of the room size.

5.10.6 Walls must extend from the floor to the ceiling.

5.10.7 Doors must be closable.

5.10.8 Each bedroom must have adequate electrical outlets which are conveniently located.

5.10.9 At least one (1) light fixture shall be switched at the entrance of each bedroom.

5.10.10 Walls shall be cleanable.

5.10.11 Each bedroom shall ensure adequate privacy.

5.10.12 No more than two (2) residents may share a bedroom.

5.11 Bedroom furnishings for each resident must include:

5.11.1 A reading light.

5.11.2 A bed in good repair with a frame.

5.11.3 A comfortable well constructed mattress.

5.11.3.1 The mattress shall be covered or protected with non porous material.

5.11.3.2 A resident may choose to provide an individual mattress to be used only by that resident.

5.11.4 A sturdy bedside stand and chair.

5.11.5 A chest of drawers with at least 2 drawers.

5.11.6 At least two (2) linear feet in a closet for hanging clothes.

5.12 Bathrooms

5.12.1 Floor and wall surfaces shall be constructed and maintained to be impervious to water and to permit the floor and walls to be easily kept in a clean condition.

5.12.2 At least one (1) window or mechanical ventilation to the outside shall be provided.

5.12.3 Floor surfaces shall be durable, yet non-abrasive and slip-resistant. Floor surfaces shall be kept in good repair.

5.12.4 There shall be one (1) bathtub or shower for every six (6) occupants.

5.12.4.1 Each bathtub or shower shall be in an individual room or enclosure which provides private space for bathing, drying and dressing.

5.12.4.2 Each bathtub or shower shall be equipped with grab bars and slip-resistant surfaces.

5.12.5 There shall be at least one (1) toilet for every eight (8) occupants which shall be located on the same level as the resident's bedroom(s).

5.12.5.1 When more than one (1) toilet is located in the same room, provisions for private use shall be made.

5.12.5.2 Each toilet shall be equipped with a substantial grab bar.

5.12.6 There shall be at least one (1) hand washing sink for every eight (8) occupants which shall be located on the same level as the resident's bedroom(s).

5.12.6.1 The hand washing sink shall have hot and cold water.

5.13 Kitchen

5.13.1 Floor, wall and counter surfaces shall be constructed and maintained to be impervious to water (to the level of splash) and to permit the floor and walls to be easily kept in a clean condition.

5.13.2 There shall be:

5.13.2.1 At least one (1) refrigerator and one (1) freezing unit, in proper working order and capable of maintaining frozen foods in the frozen state and refrigerated foods at 42°F, or below, as determined in the warmest part of the refrigerator.

5.13.2.1.1 Each refrigerator shall be equipped with a refrigerator thermometer.

5.13.2.2 At least one (1) four-burner range and one (1) oven in proper working order.

5.13.2.3 A dishwasher that has a sanitizing cycle or the provider must use a dish-washing detergent containing bleach.

5.13.2.4 At least one (1) clean trash receptacle.

5.13.2.5 At least one (1) operable window or suitable exhaust system for removal of smoke, odors and fumes.

5.13.2.6 Adequate cleaning/disinfecting agents and supplies.

5.13.2.7 Storage areas with separate storage for:

5.13.2.7.1 Food, which must be stored off of the floor.

5.13.2.7.2 Cleaning agents, disinfectants and polishes.

5.13.2.7.3 Poisons, pesticides or other toxic chemicals which must be stored in locked cabinets/storage areas.

5.13.2.7.4 Eating and serving utensils, pots, pans and cooking utensils which must be stored off of the floor.

5.13.3 All food items shall be stored in closed or sealed containers or wrapping.

5.13.4 Food storage areas shall be free of food particles, dust and dirt.

5.13.5 Food preparation areas, utensils and appliances shall be cleaned following each meal prepared.

5.14 Dining and dayroom area

5.14.1 There shall be provided one (1) or more areas that are adequate in size and furnished for resident dining, recreational and social activities.

5.14.2 The furniture shall be of such condition so as not to pose a safety hazard and arranged and located as to provide convenient access to the residents.

5.14.3 When a multi-purpose room is used, it shall have sufficient space to accommodate activities in order to prevent interference of one (1) activity with another.

5.15 Sanitation and housekeeping

5.15.1 All rooms and every part of the building shall be kept clean, orderly, in good repair and free of offensive odors.

5.15.2 Waste material, obsolete and unnecessary articles, tin cans, rubbish and other litter shall not be permitted to accumulate in the home.

5.15.3 Sharps shall be stored in sanitary containers and disposed of in a sanitary manner.

5.15.4 When a separate sink is not provided for janitorial or laundry duties, the sink shall be sanitized with bleach after each use.

5.15.5 No laundry may be done in the food service area during the preparation or serving of food.

5.15.6 Laundry

5.15.6.1 Bed linens and towels must be changed at least weekly or more often as necessary.

5.15.6.2 If linen chutes are used, they will maintained in a sanitary condition.

5.15.6.3 If the clothes washing machine is in the kitchen, soiled laundry shall not be taken into the kitchen until it is ready to be washed.

5.15.6.4 The family care provider will complete laundry for residents who are incapable of doing so on their own.

**History**
- *25 DE Reg. 766 (02/01/22)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 192 (08/01/11)*
- *18 DE Reg. 569 (01/01/15)*
- *25 DE Reg. 766 (02/01/22)*

##### **16 Del. Admin. Code § 3315-6.0** Fire Safety {#sec-3315-6.0 omnilex-key=us-de-regs-official--title-16--3315-6.0}

6.1 There must be a functioning UL approved smoke detector on each level of the residence and in the hall adjacent to the resident bedrooms.

6.2 There shall be at least one functional fire extinguisher, that is readily accessible, on each floor of living space in the home.

6.3 Written notification to the Department by the State Fire Marshal of the existence of a fire hazard in the FCH may be grounds for revocation of a license.

6.4 The Department may require an inspection by a certified electrician at any time for good cause.

**History**
- *25 DE Reg. 766 (02/01/22)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 192 (08/01/11)*
- *18 DE Reg. 569 (01/01/15)*
- *25 DE Reg. 766 (02/01/22)*

##### **16 Del. Admin. Code § 3315-7.0** Resident Services {#sec-3315-7.0 omnilex-key=us-de-regs-official--title-16--3315-7.0}

7.1 Healthcare

7.1.1 Each resident shall have a physical/medical examination within 90 days prior to placement.

7.1.2 Each resident shall have a physical/medical examination annually or more frequently as required by a physician or the affiliated social agency/program.

7.1.3 Medications

7.1.3.1 Medications prescribed for residents shall be kept locked in a cabinet or a lock box set aside for that exclusive purpose.

7.1.3.2 Medications requiring refrigeration shall be kept locked in a separate box within the refrigerator.

7.1.3.3 Medications shall be self-administered or distributed directly to the resident from the prescription container in strict accordance with the prescription directions.

7.1.3.4 The family care provider shall ensure that prescription medication is not used by other than the resident for whom the medication was prescribed.

7.1.4 The family care provider shall maintain a list of each resident's licensed independent practitioner(s), the contact information for each and all medications taken by the resident.

7.1.5 Communicable disease

7.1.5.1 A person with an active communicable disease may not be admitted to an FCH until the individual is no longer contagious.

7.1.5.2 A resident with an active communicable disease must receive prompt medical treatment and supervision.

7.1.5.3 The family care provider shall assume responsibility for seeing that necessary precautions are taken and that there is a minimum danger of transmission of a communicable disease to any occupant of the home.

7.1.5.4 Minimum requirements for tuberculosis (TB) testing require all occupants to have a base line two step tuberculin skin test.

7.1.5.4.1 Original home occupants must complete the baseline PPD testing prior to acceptance of any resident.

7.1.5.4.2 Potential residents must have baseline testing within the six (6) month period prior to admission.

7.1.5.5 All homes shall have on file evidence of an annual vaccination against influenza for all residents unless refused or medically contraindicated.

7.2 Food service

7.2.1 A minimum of three (3) meals shall be available and/or served in each twenty-four (24) hour period.

7.2.2 There shall not be more than a 14 hour span between the evening and breakfast meals unless suitable nourishment is provided in the interim.

7.2.3 The food served shall be suitably prepared and of sufficient quantity and quality to meet the nutritional needs of the residents.

7.2.4 Special diets shall be served on the written prescription of the resident's physician.

7.2.5 A three (3) day supply of food and water for emergency feeding shall be on the premises.

**History**
- *25 DE Reg. 766 (02/01/22)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 192 (08/01/11)*
- *18 DE Reg. 569 (01/01/15)*
- *25 DE Reg. 766 (02/01/22)*

##### **16 Del. Admin. Code § 3315-8.0** Resident Rights {#sec-3315-8.0 omnilex-key=us-de-regs-official--title-16--3315-8.0}

8.1 Every resident shall have the right to receive considerate, respectful, and appropriate care, treatment and services, recognizing each person's basic personal and property rights which include dignity and individuality.

8.2 Prior to the admission of a resident, the family care provider shall provide to the resident a complete statement enumerating all charges for services, materials and equipment which may be furnished during the period of residence.

8.2.1 Each resident or legal representative shall be made aware of these charges and sign a statement of agreement prior to admission.

8.2.2 The care provider will not engage in financial transactions with a resident other than the agreed upon rate and approved incidental expenses.

8.2.3 Any revocation and/or change in any part of the financial agreement shall be coordinated with the Affiliated Social Agency/Program, placement agency, or State Long Care Ombudsman.

8.3 Every resident shall receive respect and privacy in the resident's own medical care program.

8.4 Every resident shall be free from chemical and physical restraints imposed for purposes of discipline and convenience.

8.5 Every resident shall receive from the family care provider a courteous, timely and reasonable response to requests, and the family care provider shall make prompt efforts to resolve grievances. Responses to requests and grievances shall be made in writing upon written request by the resident.

8.6 Every resident may associate and communicate, including visits and visitation, privately and without restriction with persons and groups of the resident's own choice at any reasonable hour.

8.7 Every resident may send and shall receive mail promptly and unopened.

8.8 Every resident shall have access at any reasonable hour to a telephone where the resident may speak privately.

8.9 Every resident shall have access to writing instruments, stationery and postage.

8.10 Every resident has the right to manage her/his financial affairs.

8.10.1 If, by written request signed by the resident or the legal representative, the family care provider manages the resident's financial affairs, the family care provider shall:

8.10.1.1 Have a monthly accounting of expenditures available for inspection; and,

8.10.1.2 Shall furnish the resident or resident's legal representative with a quarterly statement of the resident's account.

8.10.1.3 The resident shall have unrestricted access to such account at reasonable hours.

8.11 If married, every resident shall enjoy privacy in visits by the resident's spouse.

8.12 Every resident has the right of privacy in the resident's own room and the family care provider shall respect this right by knocking on the door before entering the resident's room.

8.13 A resident shall not be required to perform services for the FCH.

8.14 Every resident shall have the right to retain and use the resident's own personal clothing and possessions where reasonable, and shall have the right to security in the storage and use of such clothing and possessions.

8.15 Every resident shall be fully informed, in language the resident can understand, of the resident's rights and all rules and regulations governing resident conduct and the resident's responsibilities during the stay at the FCH.

8.16 Every resident shall have the right to choose a personal attending physician.

8.17 Every resident shall have the right to examine the results of the most recent survey of the FCH.

8.18 Every resident shall have the right to receive information from the protection and advocacy agency and agencies acting as client advocates and be afforded the opportunity to contact those agencies.

8.19 Every resident shall be free from verbal, physical or mental abuse, cruel and unusual punishment, involuntary seclusion, withholding of monetary allowance, withholding of food and deprivation of sleep.

8.20 Every resident shall be free to make choices regarding activities, roommates, schedules, health care and other aspects of the resident's life that are significant to the resident, as long as such choices do not compromise the health or safety of the resident or other residents within the FCH.

8.21 Every resident has the right to participate in an ongoing program of activities designed to meet the resident's interests and physical, mental and psychosocial well-being.

8.22 Every resident shall have the right to participate in social, religious and community activities that do not interfere with the rights of other residents.

8.23 Every resident shall receive notice before the resident's room or roommate is changed, except in emergencies.

8.24 Every resident shall be encouraged to exercise the resident's own rights as a citizen of the State and the United States of America.

8.25 Each resident will be encouraged to be out of bed during the day unless ill.

**History**
- *25 DE Reg. 766 (02/01/22)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 192 (08/01/11)*
- *18 DE Reg. 569 (01/01/15)*
- *25 DE Reg. 766 (02/01/22)*

##### **16 Del. Admin. Code § 3315-9.0** Records and Reports {#sec-3315-9.0 omnilex-key=us-de-regs-official--title-16--3315-9.0}

9.1 The family care provider must maintain the following records for each resident:

9.1.1 Resident's name, social security number and other appropriate information;

9.1.2 Date of admission to the FCH;

9.1.3 Physician(s) name(s) and contact information;

9.1.4 Next of kin's name and contact information;

9.1.5 A list of all medications taken by the resident;

9.1.6 Certificate as to required level of care; and,

9.1.7 Burial plans.

**History**
- *25 DE Reg. 766 (02/01/22)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 192 (08/01/11)*
- *18 DE Reg. 569 (01/01/15)*
- *25 DE Reg. 766 (02/01/22)*

##### **16 Del. Admin. Code § 3315-10.0** Disciplinary Actions {#sec-3315-10.0 omnilex-key=us-de-regs-official--title-16--3315-10.0}

10.1 Any person who fails to comply with these regulations shall be fined not less than $100 and not more than $1000, together with costs, unless otherwise provided by law.

10.2 Before any disciplinary action is taken:

10.2.1 The Department shall give ten calendar days written notice to the holder of the license, setting forth the reasons for the determination.

10.2.2 The disciplinary action shall become final ten calendar days after the mailing of the notice unless the licensee, within such ten calendar day period, shall give written notice of the desire for a hearing.

10.2.2.1 If the licensee gives such notice, the licensee shall be given a hearing before the Secretary of the Department or her/his designee and may present such evidence as may be proper.

10.2.2.2 The Secretary of the Department or her/his designee shall make a determination based upon the evidence presented.

10.2.2.3 A written copy of the determination and the reasons upon which it is based shall be sent to the licensee.

10.2.2.4 The decision shall become final ten calendar days after the mailing of the determination letter unless the licensee, within the ten calendar day period, appeals the decision to the appropriate court of the State.

**History**
- *25 DE Reg. 766 (02/01/22)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 192 (08/01/11)*
- *18 DE Reg. 569 (01/01/15)*
- *25 DE Reg. 766 (02/01/22)*

##### **16 Del. Admin. Code § 3315-11.0** Infection Prevention and Control Program {#sec-3315-11.0 omnilex-key=us-de-regs-official--title-16--3315-11.0}

11.1 The FCH shall establish an infection prevention and control program which shall be based upon Centers for Disease Control and Prevention and other nationally recognized infection prevention and control guidelines.

11.1.1 The infection prevention and control program must cover all services and all areas of the FCH, including provision of the appropriate personal protective equipment for all occupants of the FCH and visitors.

11.2 The individual designated to lead the FCH's infection prevention and control program must develop and implement a comprehensive plan that includes actions to prevent, identify, and manage infections and communicable diseases. The plan must include mechanisms that result in immediate action to take preventive or corrective measures that improve the FCH's infection control outcomes.

11.3 All staff shall receive orientation at the time of employment and annual in-service education regarding the infection prevention and control program.

11.4 Specific Requirements for COVID-19

11.4.1 Before their start date, all new staff, vendors and volunteers must be tested for COVID-19 in accordance with Division of Public Health guidance.

11.4.2 All staff, vendors and volunteers must be tested for COVID-19 in a manner consistent with Division of Public Health guidance.

11.4.3 The FCH must follow recommendations of the Centers for Disease Control and Prevention and the Division of Public Health regarding the provision of care or services to residents by staff, vendor or volunteer found to be positive for COVID-19 in an infectious stage.

11.5 The FCH shall amend their policies and procedures to include:

11.5.1 Work exclusion and return to work protocols for staff tested positive for COVID-19;

11.5.2 Staff refusals to participate in COVID-19 testing;

11.5.3 Staff refusals to authorize release of testing results or vaccination status to the FCH;

11.5.4 Procedures to obtain staff authorizations for release of laboratory test results to the FCH to inform infection control and prevention strategies; and

11.5.5 Plans to address staffing shortages and FCH demands should a COVID-19 outbreak occur.

**History**
- *25 DE Reg. 766 (02/01/22)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 192 (08/01/11)*
- *18 DE Reg. 569 (01/01/15)*
- *25 DE Reg. 766 (02/01/22)*

##### **16 Del. Admin. Code § 3315-12.0** Severability {#sec-3315-12.0 omnilex-key=us-de-regs-official--title-16--3315-12.0}

Should any section, sentence, clause or phrase of these regulations be legally declared unconstitutional or invalid for any reason, the remainder of said regulations shall not be affected thereby.

State Board of Health Regulations adopted pursuant to 16 Del.C. 1109 July 1, 1956. Amended March 13, 1962. December 18, 1969, November 24, 1971, February 17, 1972, December 27, 1972, May 23, 1973, August ‑21, 1975, August 8, 1977, January 25, 1978, September 19, 1978, October 17, 1978, October 14,1980, April 14, 1981, March 3, 1983, to be effective April 1,1983, February 1, 1989, and March 3, 1993, to be effective March 4, 1993.

**History**
- *25 DE Reg. 766 (02/01/22)*
- *14 DE Reg. 1360 (06/01/11)*
- *15 DE Reg. 192 (08/01/11)*
- *18 DE Reg. 569 (01/01/15)*
- *25 DE Reg. 766 (02/01/22)*

#### **3320** Intensive Behavioral Support and Educational Residence

##### **16 Del. Admin. Code § 3320-1.0** Definitions {#sec-3320-1.0 omnilex-key=us-de-regs-official--title-16--3320-1.0}

The following words and terms, when used in this regulation, have the following meaning unless the context clearly indicates otherwise:

“Authorized Representative” means the person, on behalf of a resident without decision-making capacity, who has the highest priority to act for the resident under law, and who has the authority to make decisions on behalf of the resident. The resident's authorized representative could be a person designated by a resident under an advance health-care directive, an agent under a medical durable power of attorney for health-care decisions or financial decisions, a guardian of the person appointed pursuant to 12 Del.C. Chs. 39 and 39A, in accordance with the authority granted by the appointing court, a surrogate appointed under 16 Del.C. Ch. 25, a person designated by a resident pursuant to 16 Del.C. Ch. 94A, or an individual who is otherwise authorized under applicable law to make the decisions on the resident's behalf, if the resident lacks decision-making capacity.

“Behavior Management Committee” or “BMC” means the group that establishes and reviews each resident’s Specialized Behavior Support Plan (SBS Plan).

“Chemical Restraint" means the use of any medication that is used for discipline or convenience to effect control over a resident's behavior, and is not required to treat a medical symptom. Chemical restraint is prohibited.

“Department” means the Department of Health and Social Services.

“Director” means the individual employed by the IBSER and responsible for oversight of the Delaware facilities.

“Human Rights Committee” or “HRC” means an advisory group established to monitor the rights and welfare of persons receiving services from an IBSER.

“Incident” means an unexpected and usually unpleasant occurrence that interrupts normal procedure or functioning.

“Intensive Behavioral Support and Educational Residence” or “IBSER” means a residential dwelling for no more than ten residents which provides services to residents 18 years and over with autism and/or intellectual/developmental disabilities and who also have specialized behavioral needs. These homes offer 24 hour supports to residents with intellectual/developmental disabilities with specialized behavioral needs.

“Intervention Tracking Sheet” means a form, approved by the Department, which documents types of physical interventions used when residents are not able to control their own behavior.

“Licensed Independent Practitioner” means a person currently licensed as an advanced practice nurse pursuant to 24 Del.C. Ch. 17 of the Delaware Code, a person currently licensed as a physician’s assistant pursuant to 24 Del.C. Ch. 19 of the Delaware Code, or a person currently licensed as a physician pursuant to 24 Del.C. Ch. 19 of the Delaware Code.

“Limited Lay Administration of Medication” means the administration of medication by unlicensed assistive personnel as defined in 24 Del.C. §1932.

“Physical Intervention” means use of manual holding to suppress challenging behavior. Physical restraint by means of a device is prohibited.

“Reportable Incident” means an occurrence, event or suspicion of same which must be reported immediately to the Director and within 8 hours to the Department. An allegation of abuse must be reported to the Department within 2 hours of the occurrence.

“Resident” means the individual residing in an IBSER.

“Specialized Behavior Support Plan” or “SBS Plan” means a written document which describes the resident’s plan of care. The SBS is developed in conjunction with the resident and authorized representative.

“Timeout” means voluntary confinement of the resident in an area removed from other residents.

**History**
- *25 DE Reg. 767 (02/01/22)*
- *15 DE Reg. 1603 (05/01/12)*
- *23 DE Reg. 43 (07/01/19)*
- *25 DE Reg. 767 (02/01/22)*

##### **16 Del. Admin. Code § 3320-2.0** Licensing and General Requirement {#sec-3320-2.0 omnilex-key=us-de-regs-official--title-16--3320-2.0}

2.1 No person shall establish, conduct or maintain in this State any IBSER without first obtaining a license from the Department.

2.1.1 Issuance of Licenses

2.1.1.1 Initial License

2.1.1.1.1 An initial license approval will be granted to those applicants who meet the requirements for licensure.

2.1.1.1.2 Once an initial license approval has been issued, the applicant may accept residents.

2.1.1.1.3 An initial license shall be issued when the first residents move in and shall be for a term of six (6) months, during which a follow-up inspection will be conducted.

2.1.1.1.3.1 If the applicant meets the licensing requirement at the end of the six (6) month period, an annual license for the remainder of the licensure year will be issued.

2.1.1.1.3.2 If the applicant does not meet the requirements but shows the ability to meet the requirements, a provisional licensed may be issued for a period of 90 days pending the implementation of corrective actions.

2.1.1.2 Provisional License

2.1.1.2.1 A provisional license may be granted for a period of 90 days to an IBSER that, after inspection by the Department, is not in substantial compliance with these rules and regulations but has demonstrated the ability and willingness to comply within the 90-day period.

2.1.1.2.2 The Department shall designate the conditions and the time period under which a provisional license is issued.

2.1.1.2.3 A provisional license may not be renewed.

2.1.1.2.4 A license will not be granted pursuant to subsection 2.1.1.3 after the provisional licensure period to any IBSER that is not in substantial compliance with these rules and regulations.

2.1.1.3 Annual License

2.1.1.3.1 A license shall be granted, for a period of one year (12 months), to all IBSERs which are and remain in substantial compliance with these rules and regulations.

2.1.1.3.2 A license shall be effective for a twelve-month period following date of issue and shall expire one year following such date, unless it is: modified to a provisional license, suspended, revoked, or surrendered prior to the expiration date.

2.1.1.3.3 All applications for renewal of licenses shall be filed with the Department at least 45 days prior to expiration.

2.1.1.3.4 A license will not be issued to an IBSER which is not in substantial compliance with these regulations and/or whose deficient practices present an immediate threat to the health and safety of its residents.

2.1.2 Suspension or Revocation of Licenses

2.1.2.1 The Department may suspend or revoke a license issued under this Section for good cause, including but not limited to the following:

2.1.2.1.1 Violation of any of the provisions of these rules and regulations or 16 Del.C. Ch. 11.

2.1.2.1.2 Deficiencies which present a threat to the health and safety of residents.

2.1.2.1.3 Permitting, aiding, or abetting the commission of any illegal act in the IBSER.

2.1.2.1.4 Conduct or practices which the Department determines pose a serious threat to the health and safety of a resident or residents.

2.1.2.1.5 Refusal to allow the Department access to the IBSER to conduct surveys/investigations as deemed necessary by the Department.

2.1.2.2 Before any license issued under this Section is suspended or revoked, the Department shall give 10 calendar days written notice to the holder of the license, during which the holder may appeal, in writing, for a hearing before the Secretary of the Department or her/his designee.

2.1.3 Imposition of Disciplinary Action

2.1.3.1 Before any other enforcement action is taken under this Section, the Department shall give 20 calendar days written notice to the holder of the license, during which the holder may appeal, in writing, for a hearing before the Secretary of the Department or her/his designee.

2.1.3.2 The due process protections of notice and opportunity to be heard shall be provided to facilities and the hearing process shall be consistent with the Administrative Procedures Act, 29 Del.C. Ch. 101.

2.1.4 Fees

2.1.4.1 Fees shall be in accordance with 16 Del.C. Ch. 11.

2.1.5 A license is not transferable from one IBSER to another or from one location to another.

2.1.6 A new license shall be required in the event of a change in the IBSER management company, building owner or controlling person.

2.1.7 The license shall be readily available in the IBSER for which it was issued.

2.2 Inspection

2.2.1 Every IBSER for which a license has been issued under this Section shall be inspected regularly and as determined necessary by the Department.

2.3 Application Process

2.3.1 All persons or entities applying for a license shall request a licensure application from the Department.

2.3.2 The issuance of an application form is in no way a guarantee that the completed application will be accepted or that a license will be issued by the Department.

2.3.3 IBSERs applying for an initial license, must submit:

2.3.3.1 Evidence of a satisfactory compliance history, as appropriate, during the preceding five years.

2.3.3.2 A list of all facilities managed, owned or controlled by the applicant or associated entity in any jurisdiction during the preceding five years.

2.3.3.3 Financial information as required by the Department.

2.3.3.3.1 Financial information disclosed to the Department shall not be subject to Freedom of Information Act requests.

2.4 Separate licenses are required for separate homes maintained in separate locations, regardless of their proximity, even though operated by the same IBSER.

2.5 The term “IBSER” shall not be used as part of the name of any program in this State unless the home is licensed under these regulations.

2.6 No IBSER shall adopt rules that conflict with these regulations.

2.7 The Department shall be notified in writing at least 90 days before any changes in the ownership or management of an IBSER.

2.8 Each IBSER shall provide, to all residents and authorized representatives, a complete statement listing all charges for services, materials and equipment that shall (or may be) furnished to the resident during the period of residency as part of the admission agreement.

2.9 Each IBSER shall provide a written statement at the time of admission that includes the refund and prepayment policy; and clarifies responsibility in the event of a retroactive denial in the case of a third party payment.

2.10 All required records maintained by the residence must be open to inspection by authorized representatives of the Department.

2.11 No rules may be adopted by the licensee or administrators which are in conflict with these regulations.

2.12 The Department must be notified, in writing, within 10 calendar days of any change in the Director.

2.13 The IBSER must provide safe storage for residents' valuables.

2.14 Each IBSER shall cooperate fully with the Medicaid Fraud Control Unit and the state protection and advocacy agency, as defined in 16 Del.C. §1102(7), in fulfilling functions authorized by 16 Del.C. Ch. 11.

2.15 Each facility shall prominently and conspicuously post for display in a public area of the facility that is readily available to residents, employees, and visitors a sign, prescribed by the Department, that specifies complaint and abuse reporting procedures and provides the "1-800" hotline number to receive complaints 24 hours a day, 7 days a week.

**History**
- *25 DE Reg. 767 (02/01/22)*
- *15 DE Reg. 1603 (05/01/12)*
- *23 DE Reg. 43 (07/01/19)*
- *25 DE Reg. 767 (02/01/22)*

##### **16 Del. Admin. Code § 3320-3.0** Policies and Procedures {#sec-3320-3.0 omnilex-key=us-de-regs-official--title-16--3320-3.0}

3.1 The IBSER shall maintain and comply with a written policy and procedure manual.

3.1.1 The manual must be updated as necessary to comply with changes in state and/or federal laws and regulations.

3.1.2 The manual must be reviewed at least annually.

3.1.3 Staff must be notified promptly of changes and provided necessary education.

3.2 The IBSER shall establish written policies and procedures regarding:

3.2.1 Transfer, discharge and readmission.

3.2.2 Behavior support that uses person-centered positive behavior support techniques that are consistent with the policies/standards and that are monitored by the Human Rights Committee.

3.2.3 The utilization of reportable incident data to track trends in and help prevent further incidents.

3.2.4 The system for reporting and processing of reportable incidents.

3.2.5 Open communication with persons of the community in which the IBSER is located in order to facilitate the resident’s community integration.

3.2.6 Criminal background check and drug testing laws as required under 16 Del.C. Ch. 11.

3.2.7 The implementation and documentation of the person-centered plan.

3.2.8 Employment/Personnel which shall include:

3.2.8.1 Qualifications, responsibilities and requirements for each job classification;

3.2.8.2 Pre-employment requirements;

3.2.8.3 Position descriptions;

3.2.8.4 Supervision, promotion and discipline;

3.2.8.5 Orientation for all employees and contractors including any guidelines for specialized training;

3.2.8.6 In-service education policy; and

3.2.8.7 Annual performance review and competency testing.

3.2.9 The rights of residents.

3.2.10 The safeguarding of the residents’ funds while still allowing access to the residents’ funds at all times.

3.2.11 The safeguarding of the residents’ personal information.

3.2.12 Infection prevention and control.

3.2.13 Administration, limited lay administration (LLAM) and self-administration of medication.

3.2.14 Maintenance (including electrical maintenance) and cleaning procedures, storage of cleaning materials and/or pesticides and other toxic materials.

3.2.15 The prohibition of firearms on the premises of the IBSER.

3.2.16 Abuse, neglect, mistreatment and financial exploitation.

3.2.17 Health care decisions in accordance with 16 Del.C. Ch. 25.

3.2.17.1 Verification that this information was given to the resident/authorized representative must be filed in the resident’s record.

3.2.18 All hazards emergency procedures.

**History**
- *25 DE Reg. 767 (02/01/22)*
- *15 DE Reg. 1603 (05/01/12)*
- *23 DE Reg. 43 (07/01/19)*
- *25 DE Reg. 767 (02/01/22)*

##### **16 Del. Admin. Code § 3320-4.0** Environment {#sec-3320-4.0 omnilex-key=us-de-regs-official--title-16--3320-4.0}

4.1 Site Provisions

4.1.1 Each IBSER shall be located on a site which is considered suitable by the Department.

4.1.2 The site must be safe, easily drained, must be suitable for disposal of sewage and furnishing a potable water supply.

4.1.3 The exterior of the site shall be free from hazards and also from the accumulation of waste materials, obsolete and unnecessary articles, tin cans, rubbish, and other litter.

4.2 The IBSER must have a safe and sanitary environment, properly constructed, equipped, and maintained to protect the health and safety of residents.

4.3 The IBSER shall comply with all local and state building codes and ordinances as pertain to this occupancy.

4.4 Physical Plant

4.4.1 All construction - new, renovations, or remodeling - must conform to the local building codes, current at the time of construction.

4.4.2 When an IBSER plans to construct or extensively remodel a licensed home or convert a building to a licensed home, it shall submit one copy of properly prepared plans and specifications for the entire home to the Department.

4.4.2.1 An approval, in writing, shall be obtained before such work is begun.

4.4.2.2 All completed construction, extensive remodeling or conversions shall remain in accordance with the plans and specifications, as approved by the Department.

4.4.2.3 The Department must visit the site upon completion of the work to ensure that the work was completed according to plans submitted.

4.4.3 Windows

4.4.3.1 Window space shall not be less than one tenth (1/10) of the floor space.

4.4.3.1.1 Up to 25% reduction may be allowed when approved mechanical ventilation is utilized in multi-bed rooms.

4.4.3.2 All windows in rooms to be used by residents are to be constructed to eliminate drafts and to provide adequate light and ventilation.

4.4.3.3 All windows designed to open and shut must be functional.

4.4.4 The building shall be constructed and maintained to prevent the entrance, and control the existence, of rodents and insects.

4.4.4.1 All exterior openings shall be effectively screened.

4.4.4.2 Screen doors shall open outward and shall be equipped with self-closing devices.

4.4.4.3 All screening shall have at least 16 mesh per inch.

4.4.5 Resident bedrooms shall open directly into a corridor.

4.4.6 IBSERs accommodating individuals who regularly require wheelchairs shall be equipped with ramps.

4.4.6.1 Egress ramps must be located at the primary means of egress.

4.4.6.1.1 A secondary means of egress that is independent and remotely located from the primary means of egress must be provided to the outside of the dwelling at street/ground level or open to an exterior balcony.

4.4.6.2 Ramps must be compliant with the standards outlined in Americans with Disabilities Act (ADA).

4.4.7 The physical dimensions of the home will provide, as a minimum, 150 square feet of common living space for the first occupant and 100 square feet of living space for each additional occupant.

4.4.8 The roof, exterior walls, doors, skylights and windows shall be weather tight and watertight and shall be kept in sound condition and good repair.

4.5 Water supply and sewage disposal

4.5.1 Non-public water systems must be approved by the Department.

4.5.1.1 Providers must sample non-public water annually and have it tested by the Department.

4.5.1.1.1 A copy of all water testing results must be kept on site at the IBSER.

4.5.2 Non-public sewage disposal systems must be approved by the Department of Natural Resources and Environmental Control.

4.5.3 The water system must supply adequate hot and cold water, under pressure, at all times.

4.5.4 The plumbing shall meet the requirements of all municipal or county codes. Where there are no local codes, the provisions of the Department Sanitary Plumbing Code shall prevail.

4.5.5 Hot water at shower, bathing and hand washing facilities shall not exceed 115°F (46°C).

4.6 A licensee must ensure that the home’s premises and equipment accessible to or used by residents are free from any danger to their health, safety and well-being.

4.7 Electric shall meet all municipal, county and State requirements and laws.

4.8 Each room and access way shall be suitably lighted at all times for maximum safety, comfort, sanitation and efficiency of operation particularly in areas that present safety hazards. Careful attention shall be given to avoid glare.

4.9 Safety equipment

4.9.1 Stairways shall have non-slip surfaces and sturdy handrails to prevent slipping. Stairways over six (6) feet in width shall have handrails on both sides.

4.9.2 Working electric switches shall be located at the top and the bottom of stairways.

4.9.3 Hallways shall be equipped with working night-lights.

4.9.4 Floor surfaces shall be durable, yet non-abrasive and slip-resistant. Floor surfaces shall be kept in good repair. Area rugs on hard finished floors shall have a non-skid backing. Carpeting shall be maintained in a clean condition.

4.9.5 All interior doors in areas used by residents shall be capable of being opened from either side at all times.

4.9.6 Cameras or monitoring devices are not permitted in resident bedrooms or bathrooms unless written permission by resident(s) or authorized representative(s) is on file.

4.10 Bedrooms

4.10.1 Each bedroom shall be well-ventilated.

4.10.2 Each bedroom shall be an outside room with at least one (1) window opening directly to the outside.

4.10.3 A one (1) person bedrooms shall be at least 100 square feet.

4.10.4 Multi-bed bedrooms shall:

4.10.4.1 Provide at least eighty (80) square feet of floor space per person.

4.10.4.2 Be adequately spaced for comfort.

4.10.4.3 Have the beds spaced at least three (3) feet apart. Bunk beds are prohibited.

4.10.5 The ceiling height shall be not less than seven (7) feet from the floor on average. Areas where the height of the ceiling is less than five (5) feet shall not be counted in the determination of the room size.

4.10.6 Walls must extend from the floor to the ceiling.

4.10.7 Doors must be closable and lockable.

4.10.8 Each bedroom must have adequate electrical outlets which are conveniently located.

4.10.9 At least one (1) light fixture shall be switched at the entrance to each bedroom.

4.10.10 Walls shall be cleanable.

4.10.11 Each bedroom shall ensure adequate privacy.

4.10.12 No more than two (2) residents may share a bedroom.

4.10.13 Residents may furnish and decorate their own bedrooms.

4.10.14 Mattresses shall be covered or protected with non-porous material.

4.10.15 Each bedroom shall provide storage space for clothing and storage space for personal items to include, minimally, closet space.

4.10.16 Bedrooms shall contain space, as needed, for bedside assistance and to accommodate the use and storage of mobility devices and prosthetic equipment.

4.11 Bathrooms

4.11.1 Floor and wall surfaces shall be constructed and maintained to be impervious to water and to permit the floor and walls to be easily kept in a clean condition.

4.11.2 At least one (1) window or mechanical ventilation to the outside shall be provided.

4.11.3 Floor surfaces shall be durable, yet non-abrasive and slip-resistant. Floor surfaces shall be kept in good repair.

4.11.4 There shall be at least one (1) bathtub or shower for every four (4) residents.

4.11.4.1 Each bathtub or shower shall be in an individual room or enclosure which provides private space for bathing, drying and dressing.

4.11.4.2 Each bathtub or shower shall be equipped with substantial grab bars and slip-resistant surfaces.

4.11.5 There shall be at least one (1) toilet of appropriate size for each four (4) residents which shall be located on the same level as the residents’ bedrooms.

4.11.5.1 When more than one (1) toilet is located in the same room, provisions for private use shall be made.

4.11.5.2 Each toilet shall be equipped with a substantial grab bar.

4.11.5.3 Each toilet shall be equipped with a toilet seat and toilet tissue.

4.11.6 There shall be at least one (1) hand washing sink for every four (4) residents which shall be located on the same level as the residents’ bedrooms.

4.11.6.1 The hand washing sink shall have hot and cold water.

4.11.6.2 Hand washing sinks shall be available in or immediately adjacent to bathrooms and/or toilet rooms.

4.11.7 Unbreakable mirrors, fastened to the wall, shall be furnished in bathrooms, including mirrors that are accessible by residents who use wheelchairs.

4.12 Kitchen

4.12.1 Floor, wall and counter surfaces shall be constructed and maintained to be impervious to water (to the level of splash) and to permit the floor and walls to be easily kept in a clean condition.

4.12.2 There shall be:

4.12.2.1 At least one (1) refrigerator and one (1) freezing unit, in proper working order and capable of maintaining frozen foods in the frozen state and refrigerated foods at 41 degrees Fahrenheit or below, as determined in the warmest part of the refrigerator.

4.12.2.1.1 Each refrigerator shall be equipped with a refrigerator thermometer.

4.12.2.2 At least one (1) four-burner range and one (1) oven (or combination thereof) which is in proper working order.

4.12.2.3 A commercial dishwasher or the home must use a dishwasher detergent with sanitizer.

4.12.2.4 At least one (1) clean trash receptacle.

4.12.2.5 At least one (1) operable window or suitable exhaust system for removal of smoke, odors and fumes.

4.12.2.6 Adequate cleaning/disinfecting agents and supplies.

4.12.2.7 Storage areas with separate storage for:

4.12.2.7.1 Food, which must be stored off of the floor.

4.12.2.7.1.1 Dry or staple food items shall be stored at least six (6) inches above the floor in a ventilated room that is not subject to waste water back flow or to contamination by condensation or leakage.

4.12.2.7.2 Cleaning agents, disinfectants and polishes.

4.12.2.7.3 Poisons, pesticides or other toxic chemicals which must be stored in locked cabinets/storage areas.

4.12.2.7.3.1 Safety Data Sheets (SDS) must be available for any poisons, pesticides or toxic chemicals stored on-site.

4.12.2.7.4 Eating and serving utensils, pots, pans and cooking utensils which must be stored off of the floor.

4.12.3 All food items shall be stored in closed or sealed containers or wrapping.

4.12.4 Food storage areas shall be free of food particles, dust and dirt.

4.12.5 Food preparation areas, utensils and appliances shall be cleaned following each meal prepared.

4.12.6 Opened foods that are to be stored shall immediately be dated with the date that the foods were opened.

4.12.7 Prepared and leftover foods requiring refrigeration must be kept for no more than three (3) days.

4.13 Dining and dayroom area

4.13.1 There shall be provided one (1) or more areas that are adequate in size and furnished for resident dining, recreational and social activities.

4.13.2 The furniture shall be of such condition so as not to pose a safety hazard and arranged and located as to provide convenient access to the residents.

4.13.3 When a multi-purpose room is used, it shall have sufficient space to accommodate activities in order to prevent interference of one (1) activity with another.

4.14 Sanitation and housekeeping

4.14.1 All rooms and every part of the building shall be kept clean, orderly, in good repair and free of offensive odors.

4.14.2 Waste material, obsolete and unnecessary articles, tin cans, rubbish and other litter shall not be permitted to accumulate in the home.

4.14.3 Sharps shall be stored in sanitary containers and disposed of in a medical and disposable sharps container.

4.14.4 When a separate sink is not provided for janitorial or laundry duties, the sink shall be sanitized after each use.

4.14.5 No laundry may be done in the food service area during the preparation or serving of food.

4.14.6 Premise must be free of pests, insects and rodents.

4.14.7 Laundry

4.14.7.1 Bed linens and towels must be changed at least weekly or more often as necessary.

4.14.7.2 If linen chutes are used, they will be maintained in a sanitary condition.

4.14.7.3 If the clothes washing machine is in the kitchen, soiled laundry shall not be taken into the kitchen until it is ready to be washed.

4.14.7.4 The authorized provider will complete laundry for residents who are incapable of doing so on their own.

4.15 Providers shall ensure a home-like environment for each licensed home. Functional arrangement of rooms, furnishings, and decor shall be compatible with the need for accessibility.

4.16 Furniture and furnishings shall be safe, comfortable, cleanable and in good repair and shall resemble those in homes in the local community, to the extent compatible with residents’ choice and the physical needs of the residents living in the home. To the extent possible, personal furniture shall be chosen by residents.

4.17 Heating apparatus shall not constitute a burn, smoke or carbon monoxide hazard to residents served or their support staff.

4.18 Temperature, humidity, ventilation, and light in all living and sleeping quarters shall be maintained to provide a comfortable atmosphere.

4.19 Basement space may be used for activities for people in the home if there is a minimum of two (2) fire exits.

**History**
- *25 DE Reg. 767 (02/01/22)*
- *15 DE Reg. 1603 (05/01/12)*
- *23 DE Reg. 43 (07/01/19)*
- *25 DE Reg. 767 (02/01/22)*

##### **16 Del. Admin. Code § 3320-5.0** Records and Reports {#sec-3320-5.0 omnilex-key=us-de-regs-official--title-16--3320-5.0}

5.1 There shall be a separate record maintained on each resident as per acceptable standards of practice.

5.2 There shall be a medication administration record (MAR) including medications, dosages, frequency, route of administration, and initials of the person administering each dose. The record shall include the identity of each person administering medication.

5.3 Confidentiality of residents’ records shall be maintained in accordance with the federal Health Insurance Portability and Accountability Act (HIPAA) and 16 Del.C. §1121(6).

5.4 Records shall be retained for 6 years after discharge.

5.5 Incident reporting

5.5.1 All incidents shall be adequately documented. Adequate documentation shall include:

5.5.1.1 The name of the resident(s) involved and whether they are able to provide information regarding the incident;

5.5.1.2 The date, time and place of the incident;

5.5.1.3 A detailed description of the incident;

5.5.1.4 A list of other parties involved, including witnesses;

5.5.1.5 Witness statements;

5.5.1.6 The nature of any injuries sustained;

5.5.1.7 Resident(s) outcome(s); and

5.5.1.8 Follow-up action:

5.5.1.8.1 Notification of the resident(s) authorized representative(s), attending physician and licensing or law enforcement authorities, when appropriate;

5.5.1.8.2 The corrective action taken immediately for each resident or area impacted;

5.5.1.8.3 How the staff will act to protect residents in a similar situation;

5.5.1.8.4 What measures will be taken or what systems will be changed to ensure that the incident does not recur;

5.5.1.8.5 How the staff will measure the success of the interventions put in place.

5.6 All reports of incidents, whether or not required to be reported, shall be retained for three years.

5.7 Reportable incidents are as follows:

5.7.1 Abuse, neglect, mistreatment or exploitation as defined in 16 Del.C. Ch. 11, Subch. III, or reasonable suspicion of same.

5.7.2 Individual elopement under the following circumstances:

5.7.2.1 An individual's whereabouts on or off the premises is unknown to staff and the individual suffers harm.

5.7.2.2 A cognitively impaired individual's whereabouts are unknown to staff and the individual leaves the neighborhood home premises.

5.7.2.3 An individual cannot be found inside or outside the neighborhood home and the police are summoned.

5.7.3 Significant injuries:

5.7.3.1 Injury from an incident of unknown source in which the initial evaluation supports the conclusion that the injury is suspicious.

5.7.3.1.1 Circumstances which may cause an injury to be suspicious are:

5.7.3.1.1.1 The extent of the injury;

5.7.3.1.1.2 The location of the injury (e.g., the injury is located in an area not generally vulnerable to trauma);

5.7.3.1.1.3 The number of injuries observed at one particular point in time; or

5.7.3.1.1.4 The incidence of injuries over time.

5.7.3.2 Injury that results in transfer to an acute care facility for treatment or evaluation;

5.7.3.3 Injury that requires periodic neurologic reassessment as ordered by a licensed independent practitioner up to 24 hours;

5.7.3.4 Areas of contusions or bruises caused by staff to a dependent individual;

5.7.3.5 Injury sustained by a totally dependent individual;

5.7.3.6 A burn greater than first degree;

5.7.3.7 Any serious unusual and/or life-threatening injury.

5.7.4 Entrapment which causes the individual injury or immobility of body or limb or which requires assistance from another person for the individual to secure release.

5.7.5 Suicide or attempted suicide.

5.7.6 Poisoning.

5.7.7 Any drug overdose including a drug overdose from illegal drugs.

5.7.8 Medication/treatment error or omission when:

5.7.8.1 It results in discomfort for the individual;

5.7.8.2 It jeopardizes the individual’s health or safety; or

5.7.8.3 It requires monitoring as ordered by a licensed independent practitioner for up to 48 hours

5.7.9 Fire within an IBSER home.

5.7.10 Utility interruption lasting more than eight hours in one or more major service(s) including electricity, water supply, plumbing, heating or air conditioning, fire alarm, sprinkler system or telephones.

5.7.11 Structural damage or unsafe structural conditions.

5.7.12 Water damage that impacts individual health, safety or comfort.

5.7.13 Unexpected deaths.

5.7.14 An epidemic outbreak or illness requiring social distancing.

5.8 Incidents of alleged abuse, neglect or mistreatment must be reported to the Department within 2 hours of occurrence. Other reportable incidents shall be communicated to the Department within 8 hours of occurrence.

5.9 All reportable incidents must be thoroughly investigated by the IBSER and a written report provided to the Department within 5 business days of the incident. The written report must include all information as outlined in subsection 5.5.

5.10 The authorized provider shall maintain records and reports of fire safety, health, sanitation, and environmental inspections required by local and state laws and regulations.

5.10.1 The provider shall document actions taken to correct deficiencies noted in these reports. Corrective actions shall include:

5.10.1.1 The corrective action taken immediately for each resident or area impacted;

5.10.1.2 How the staff will act to protect residents in a similar situation;

5.10.1.3 What measures will be taken or what systems will be changed to ensure that the incident does not recur; and

5.10.1.4 How the staff will measure the success of the interventions put in place.

5.10.2 All corrective action plans must be sent to the Department for approval within 10 business days of the receipt of the report.

5.11 Personnel Records:

5.11.1 A licensee must develop, adopt and maintain on file a personnel record for every employee and volunteer.

5.11.2 The personnel record must contain the following:

5.11.2.1 Employment application;

5.11.2.2 Name, current address and phone number of the employee;

5.11.2.3 Verification of education where specified by these requirements;

5.11.2.4 Documentation of training received prior to and during employment at the IBSER or program, including titles and hours of in-service training;

5.11.2.5 Work history;

5.11.2.6 Three references from persons who are unrelated to the employee or volunteer, one of which must be from any previous employer;

5.11.2.7 Results of tuberculosis screening

5.11.2.8 Documentation of annual influenza vaccination or refusal.

5.11.2.9 Verification of completed criminal history record information check and abuse registry information check;

5.11.2.10 Verification of drug screening;

5.11.2.11 Employee job description;

5.11.2.12 Verification of receipt by the employee or volunteer of his or her current job description;

5.11.2.13 A copy of a valid Driver’s License if required to transport residents;

5.11.2.14 An annual employee performance evaluation;

5.11.2.15 Annual competency evaluation for LLAM trained employees;

5.11.2.16 Employee disciplinary actions and history;

5.11.2.17 If applicable, license/certification number and expiration date; and

5.11.2.18 All other reports required by statute or regulation.

**History**
- *25 DE Reg. 767 (02/01/22)*
- *15 DE Reg. 1603 (05/01/12)*
- *23 DE Reg. 43 (07/01/19)*
- *25 DE Reg. 767 (02/01/22)*

##### **16 Del. Admin. Code § 3320-6.0** Emergencies and Disaster Preparedness {#sec-3320-6.0 omnilex-key=us-de-regs-official--title-16--3320-6.0}

6.1 Fire safety in IBSER’s must comply with the rules and regulations of the State Fire Prevention Commission or the appropriate local jurisdiction.

6.2 The IBSER must have a minimum of two means of egress.

6.3 The IBSER must have an adequate number of UL approved smoke/carbon monoxide detectors in working order.

6.3.1 In a single level IBSER, a minimum of one smoke/carbon monoxide detector must be placed between the bedroom area and the remainder of the IBSER.

6.3.2 In a multi-story IBSER, a minimum of one smoke/carbon monoxide detector must be on each level. On levels which have bedrooms, the detector must be placed between the bedroom area and the remainder of the IBSER.

6.4 There must be at least one functional two and one-half to five pound ABC fire extinguisher on each floor of living space in the IBSER that is readily accessible to staff. Each extinguisher must be checked annually.

6.5 Evacuation drills

6.5.1 Drills shall be held quarterly on different days and at different times.

6.5.2 Drills are not to be held at night, during individuals’ sleep time, nor are they to be held in inclement weather.

6.5.3 Emergency evacuation drills must include all persons on the premises, including employees, volunteers, residents and visitors.

6.5.4 The location of egress during these evacuation drills must be varied, with window evacuation procedures discussed as an alternative, if not practiced.

6.5.5 During drills, persons must be evacuated with staff assistance to the designated safe area outside of the IBSER.

6.5.6 As evidenced by evacuation drill reports that are maintained by the IBSER, drills must assure that all persons and staff are familiar with the evacuation requirements and procedures.

6.5.6.1 Any problems persons have evacuating a building during a drill must result in a written plan of specific corrective action(s) to be taken.

6.5.7 Persons who are unable to achieve the exit schedule prescribed by the Life/Safety Code with available assistance must be provided with additional assistance.

6.6 A licensee must ensure that each newly admitted resident is provided an orientation regarding emergency procedures and the location of all exits within 48 hours of admission.

6.7 The IBSER must maintain an adequate communication system to ensure that on and off-duty personnel and local fire and safety authorities are notified promptly in the event of an emergency or disaster.

6.8 The telephone numbers of the nearest poison control center and the nearest source of emergency medical services must be posted.

6.9 Provisions must be made for emergency auxiliary heat and lighting by means of alternate sources of electric power, alternate fuels, and stand-by equipment, or arrangements with neighbors, other agencies or community resources.

6.10 Providers must identify an alternative relocation site in the event of an emergency requiring evacuation.

6.11 A licensee must prohibit the storage or use of any firearms or other weapons on the grounds of the IBSER or program or in any building used by residents.

**History**
- *25 DE Reg. 767 (02/01/22)*
- *15 DE Reg. 1603 (05/01/12)*
- *23 DE Reg. 43 (07/01/19)*
- *25 DE Reg. 767 (02/01/22)*

##### **16 Del. Admin. Code § 3320-7.0** Resident Rights {#sec-3320-7.0 omnilex-key=us-de-regs-official--title-16--3320-7.0}

IBSERs must comply with 16 Del.C. Ch. 11, Subch. II, regarding the rights of residents.

**History**
- *25 DE Reg. 767 (02/01/22)*
- *15 DE Reg. 1603 (05/01/12)*
- *23 DE Reg. 43 (07/01/19)*
- *25 DE Reg. 767 (02/01/22)*

##### **16 Del. Admin. Code § 3320-8.0** Resident Services {#sec-3320-8.0 omnilex-key=us-de-regs-official--title-16--3320-8.0}

8.1 The SBS Plan:

8.1.1 Must be developed by the resident, or the authorized representative, and the BMC within 5 days of admission to the IBSER.

8.1.1.1 The BMC must include:

8.1.1.1.1 A properly credentialed professional with documented training and experience in behavioral treatment of severe behavior disorders, and

8.1.1.1.2 A licensed independent practitioner.

8.1.2 Must conform to current best practices and ethical standards pertaining to the behavioral treatment of severe problem behavior.

8.1.3 Must be reviewed by the HRC to ensure that it conforms to current best practices and to ethical standards.

8.1.4 Must be adjusted as needed based on frequent review by the treatment team of data representing objectively measured occurrences of the problem behavior, and the impact of the intervention procedures.

8.1.5 Must be reviewed at least monthly for the first 90 days and then at least quarterly thereafter.

8.1.6 Must include informed consent rendered voluntarily and in writing by the resident or authorized representative after they have been provided with complete, accurate, and understandable information about all aspects of the intervention techniques that may be utilized with the resident.

8.1.7 Must include safeguards to minimize risks of harm and insure the resident’s safety at all times, including during physical interventions.

8.2 Healthcare

8.2.1 The provider shall ensure that residents receive needed medical, dental, visual and behavioral care.

8.2.2 The provider shall ensure that necessary screenings/appointments are scheduled within five (5) business days of receipt of an order.

8.2.3 Providers shall assist individuals to the carry out all health related orders as determined by the health care professionals.

8.2.4 Each resident shall have a physical/medical examination annually or more frequently as required by a licensed independent practitioner or the affiliated social agency/program.

8.2.5 The provider shall provide or assist to arrange for transportation for a resident’s appointments.

8.3 Medications

8.3.1 Storing and controlling medications.

8.3.1.1 Storage must be in a locked container, cabinet, refrigerator or area that is only accessible to authorized personnel. A bathroom or laundry room may not be used for medication storage.

8.3.1.2 Medications must be attended at all times; may not be left unattended and may not be accessible to unauthorized personnel.

8.3.1.3 Medications must be stored in the original labeled container.

8.3.1.4 Medications requiring refrigeration shall be kept locked in a separate box within the refrigerator.

8.3.1.5 Medications must be stored at room temperature (59-86F), unless otherwise indicated by the labeling, in a manner that protects the product itself from deterioration or container breakage.

8.3.2 Medications shall be self-administered (as approved by the BMC based on an assessment of the resident’s capabilities) or distributed directly to the resident from the prescription container in strict accordance with the prescription directions.

8.3.3 Administration of medications must be in accordance with the requirements in 24 Del.C. §1932.

8.3.3.1 LLAM trained personnel must have documentation on file that they have completed LLAM training as required by 24 Del.C. Ch. 19.

8.3.3.2 LLAM trained personnel must complete annual competencies and have documentation of same as required by 24 Del.C. Ch. 19.

8.3.3.3 Each IBSER must complete an annual LLAM report on the form provided by the Board of Nursing. The report must be submitted pursuant to 24 Del.C. Ch. 19.

8.3.4 The authorized provider shall ensure that prescription medication is not used by other than the resident for whom the medication was prescribed.

8.3.5 Topical (external) medications must be stored separately from oral (internal) medications.

8.3.6 Controlled substances must be under a double lock whether stored in a cupboard or refrigerator. A lock on an outside access door can be considered the first lock.

8.3.7 Medication must be stored at room temperature (59-86F) unless otherwise indicated by the labeling in a manner that protects the product itself from deterioration or container breakage.

8.3.8 Employees must observe for any changes in resident behavior or cognition and report same per policy requirements.

8.3.9 Documentation of medication administration.

8.3.9.1 A separate medication log must be maintained for each resident.

8.3.9.2 Each medication administered by a licensed or LLAM trained staff member must be documented.

8.3.9.3 The log must clearly document whether the medication was self-administered or administered by staff.

8.3.9.4 Staff members administering medications must legibly document their name and initials on the log.

8.3.9.5 Refused medication or resident unavailability must be documented.

8.3.10 Medications must be disposed of according to policy.

8.3.11 Psychotropic medications

8.3.11.1 Are prohibited for disciplinary purposes, for the convenience of staff or as a substitute for appropriate treatment service.

8.3.11.2 An informed, written consent of the resident or authorized representative must be secured and maintained in the resident’s file prior to the administration of any psychotropic medication.

8.3.11.3 Residents admitted or placed on a psychotropic medication must be seen and evaluated on a regular basis by a licensed independent practitioner with expertise in mental health treatment.

8.3.11.4 Documentation of such evaluations must be maintained in the resident record.

8.3.12 Residents admitted or placed on medication for chronic illness must be seen and evaluated on a regular basis by a licensed independent practitioner.

8.3.12.1 Documentation of such evaluations should be maintained in the resident record.

8.3.13 No person other than a licensed healthcare professional approved by the Division of Professional Regulation may administer medication by injection.

8.4 Communicable disease

8.4.1 A resident with an active communicable disease must receive prompt medical treatment and supervision.

8.4.2 The provider shall assume responsibility for seeing that necessary precautions are taken and that there is a minimum danger of transmission of a communicable disease to any occupant of the home.

8.4.3 Minimum requirements for tuberculosis (TB) testing require all residents to have a base line two step tuberculin skin test prior to admission.

8.4.4 All IBSERs shall have on file evidence of an annual vaccination against influenza for all residents unless refused or medically contraindicated.

8.4.4.1 The provider must document and keep on file each resident’s acceptance or refusal of the flu vaccine.

8.5 Food service

8.5.1 A minimum of three (3) meals shall be available and/or served in each 24 hour period.

8.5.2 There shall not be more than a 14 hour span between the evening and breakfast meals unless suitable nourishment is provided in the interim.

8.5.3 Individuals shall have access to food at all times.

8.5.4 The food served shall be suitably prepared and of sufficient quantity and quality to meet the nutritional needs of the residents.

8.5.5 Special diets shall be served on the written prescription of the resident's licensed independent practitioner.

8.5.6 There shall be three day supply of food and water in each home at all times as posted on the menus.

8.6 Physical Intervention

8.6.1 Physical intervention utilized must be from a training program approved by the Department.

8.6.2 All staff must be trained in the use of physical intervention techniques.

8.6.2.1 Implementation must be by personnel with documented training and experience in behavioral treatment of severe behavior disorders to insure that it is done competently, safely and ethically.

8.6.3 Physical intervention may be employed only when:

8.6.3.1 The resident is exhibiting a problem behavior that is so severe that it poses an imminent risk of serious bodily injury to self or others.

8.6.3.2 It is part of a SBS Plan that incorporates all of the elements cited below:

8.6.3.2.1 An initial medical evaluation to assess and address medical conditions that may be contributing to the problem behavior;

8.6.3.2.2 A licensed independent practitioner has determined that there are no contraindications to the use of the intervention;

8.6.3.2.3 It has been determined that less-restrictive alternative interventions are not safe, feasible or effective; and

8.6.3.2.4 A functional behavioral assessment has been conducted to identify the situations and conditions that trigger and/or maintain the severe problem behavior and means have been taken to address and correct those conditions.

8.6.4 Upon initiation of the physical intervention the following must occur:

8.6.4.1 Notification of the on-site supervisor.

8.6.4.2 Continuous monitoring of the resident during the physical intervention.

8.6.4.2.1 If the resident is observed to be in medical distress, e.g., exhibiting labored breathing, or there is evidence of physical injury, the resident must immediately be released from the physical intervention, and medical attention provided.

8.6.5 The physical intervention must be terminated when there is no imminent risk to either the resident or others.

8.6.6 At the termination of the intervention the resident must be observed by both the staff terminating the procedure and a second staff person to evaluate the resident’s medical and emotional condition.

8.6.7 If any signs of medical or emotional distress are observed, a medical and/or behavioral clinical professional must be contacted and decisions made about the next steps to resolve the situation.

8.6.8 Following the conclusion of each incident of physical intervention, the resident, staff, and any witnesses, shall participate in debriefing(s).

8.6.8.1 Debriefing for the resident shall occur as soon as possible, or within 24 hours of the incident unless the resident is unavailable or there is a documented clinical contraindication.

8.6.8.2 Staff should also debrief as soon as possible, or within 24 hours to conduct a thorough review and analysis of each incident in an effort to use the knowledge gained from the debriefing to inform policy, procedures and practices to avoid repeated use in the future, and to improve treatment outcomes.

8.6.9 Documentation of physical intervention utilization must include:

8.6.9.1 Date and time;

8.6.9.2 Staff involved;

8.6.9.3 Location;

8.6.9.4 Activity;

8.6.9.5 Antecedent conditions;

8.6.9.6 Specific behaviors observed;

8.6.9.7 Interventions implemented;

8.6.9.8 Duration of intervention;

8.6.9.9 Well-being checks;

8.6.9.10 Clinical review and approval by the Director or designee for interventions longer than 15 minutes;

8.6.9.11 Physical examination for possible injury after the termination of the intervention utilization;

8.6.9.12 Treatment provided;

8.6.9.13 Supervisor signature; and

8.6.9.14 Review by the Director or designee within one business day of an intervention when a physical intervention utilization event is less than 15 minutes.

8.6.10 A report of all episodes of physical intervention utilization must be provided to the Department on the fifth day of each month for the previous month in a manner prescribed by the Department.

8.6.11 Individual and aggregate clinical data on physical interventions for each resident must be provided to the BMC and the HRC.

8.6.12 If a resident experiences the use of a physical intervention six or more times in a 30 day period, that resident’s SBS Plan must be reviewed and, if necessary, modified.

8.6.13 Any physical intervention not in the approved physical intervention procedure and training manual is prohibited.

8.6.14 The use of any physical intervention technique that is medically contraindicated for a resident is prohibited.

8.6.15 The use of involuntary seclusion is prohibited.

8.7 Human Rights Committee (HRC)

8.7.1 Membership:

8.7.1.1 At least five licensed professionals (social worker, psychologist, registered nurse, licensed independent practitioner), two of whom must be professionally knowledgeable or experienced in the theory and ethical application of various treatment techniques used to address behavioral problems.

8.7.1.2 One member from the community or parent of a resident.

8.7.1.3 One member a licensed mental health professional (a licensed independent practitioner, a licensed clinical psychologist, or a clinical social worker).

8.7.2 A majority of Committee members must be external to the licensee or its parent organization.

8.7.3 The Committee must meet at least bi-monthly.

8.7.4 The Human Rights Committee is responsible for:

8.7.4.1 Determining that residents are receiving humane and proper treatment;

8.7.4.2 Reviewing and making recommendations regarding the policies and procedures governing the use of physical intervention;

8.7.4.3 Reviewing the physical intervention records, and reviewing incident reports required by these regulations related to the use of physical intervention; ensuring that the appropriate intervention was utilized for the documented behavior according to the approved manual and the resident’s SBS; and, advising the Director accordingly;

8.7.4.4 Recording and maintaining on file written minutes of all of its meetings, and providing the Director with a copy of these minutes;

8.7.4.5 Making inquiries into any allegations of abusive techniques or the misuse of physical intervention procedures. A report of the inquiry must be provided by the Committee to the Director and sent to the Department;

8.7.4.6 Monitoring the qualifications and training of employees who have been given responsibility for administering physical intervention procedures and to make recommendations to the Director accordingly; and

8.7.4.7 Reviewing and making recommendations on all SBS Plans.

8.8 Behavior Management Committee (BMC)

8.8.1 The BMC is also known as the professional interdisciplinary treatment team.

8.8.2 In conjunction with the resident or authorized representative, the BMC establishes and reviews the SBS Plan.

8.8.3 The development and review of the SBS must include:

8.8.3.1 The clinical efficacy and ethical acceptability of the plan;

8.8.3.2 A description of the results of the most recent functional assessment to identify environmental factors that correlate with the occurrence of dangerous target behaviors;

8.8.3.3 A description of the resident and his or her clinical/educational/vocational progress;

8.8.3.4 A description of positive reinforcement components that are designed to teach and strengthen appropriate behaviors;

8.8.3.5 A description of the most recent mental health review and recent changes in medication or other psychiatric interventions;

8.8.3.6 A description of any medical conditions that might be expected to impact on the occurrence of dangerous behaviors;

8.8.3.7 A description of any familial or other emotional variables that might be expected to impact on the occurrence of dangerous behaviors;

8.8.3.8 A summary of the risk benefit analysis for each proposed intervention; and

8.8.3.9 A summary statement as to the general effectiveness of the SBS Plan and a recommendation for future use.

8.8.4 Following approval by the BMC, the HRC must review the SBS Plan at their next meeting.

**History**
- *25 DE Reg. 767 (02/01/22)*
- *15 DE Reg. 1603 (05/01/12)*
- *23 DE Reg. 43 (07/01/19)*
- *25 DE Reg. 767 (02/01/22)*

##### **16 Del. Admin. Code § 3320-9.0** Personnel {#sec-3320-9.0 omnilex-key=us-de-regs-official--title-16--3320-9.0}

9.1 Director

9.1.1 Qualifications

9.1.1.1 Must be at least 21 years of age and must possess one of the following:

9.1.1.1.1 A master’s degree in social work, sociology, psychology, guidance and counseling, a human behavioral science or a related field from an accredited college, and three years of full-time work experience in human services or a related field, at least two years of which must have been in an administrative or supervisory capacity; or

9.1.1.1.2 A bachelor’s degree in social work, sociology, psychology, guidance and counseling, a human behavioral science or a related field from an accredited college, and five years of post-bachelor’s degree full-time work experience in human services or a related field, at least two years of which must have been in an administrative or supervisory capacity.

9.1.2 The director must adopt and implement a chain of command that ensures the proper and effective supervision and monitoring of employees and volunteers.

9.1.3 The director must be employed full-time.

9.2 Supervisor

9.2.1 Qualifications

9.2.1.1 Must be at least 21 years of age and must possess at least one of the following:

9.2.1.1.1 A master’s degree in social work, sociology, psychology, guidance and counseling, human behavioral science or a related field from an accredited college and at least two years of full-time work experience in social work, human services, counseling or a related field; or

9.2.1.1.2 A bachelor’s degree in social work, sociology, psychology, guidance and counseling, human behavioral science or a related field from an accredited college and at least four years of full-time work experience in social work, human services, counseling or a related field; or

9.2.1.1.3 An associate degree in social work, sociology, psychology, guidance and counseling, human behavioral science or a related field from an accredited college and three years of full-time work experience in an IBSER.

9.2.2 The supervisor must be employed full-time.

9.3 Direct Care Worker

9.3.1 Qualifications

9.3.1.1 Must be at least 21 years of age and must possess a high school diploma or an equivalent.

9.3.2 Each IBSER shall have dedicated direct care workers in numbers adequate to meet the care needs of each resident.

9.4 Administrative Oversight and Supervisor-to-Staff Ratios

9.4.1 The Director must ensure that there is a sufficient number of administrative, supervisory, social service, educational, recreational, direct care, and support employees or volunteers to perform the functions prescribed by these requirements and to provide for the care, needs, protection and supervision of residents.

9.4.2 The ratio of direct care workers to residents during off-grounds activities or excursions must be the same as the ratio of direct care workers to residents that are required during on-grounds activities.

9.4.3 There must be a full-time director for 1 or more IBSERs.

9.4.4 Each IBSER must have a full-time supervisor.

9.4.5 The director or supervisor must be on-call and available to the direct care workers at all times.

9.4.6 A minimum of 2 direct care workers must be on site and awake at all times when residents are present in the IBSER.

9.4.6.1 The number of direct care workers on duty must be based upon the assessment of the residents needs.

9.5 Orientation and Training of Employees and Volunteers

9.5.1 All employees and volunteers must complete a minimum of 40 hours of orientation before commencing work. This orientation will include:

9.5.1.1 The purpose, policies and procedures of the IBSER;

9.5.1.2 Their role and responsibilities for the protection of residents;

9.5.1.3 The requirements to report allegations of abuse, neglect, mistreatment and financial exploitation;

9.5.1.4 Emergency procedures and the location of emergency exits and emergency equipment, including first aid kits;

9.5.1.5 Confidentiality requirements, including Health Insurance Portability and Accountability Act (HIPAA); and

9.5.1.6 Crisis management and safety.

9.5.2 Employees must be deemed competent in physical intervention techniques prior to working with residents.

9.5.3 In addition to an initial orientation, all direct care workers must receive 40 hours of training annually to maintain, enhance or improve their knowledge and skills in carrying out their job responsibilities. Instruction must include:

9.5.3.1 Cardiopulmonary resuscitation (CPR);

9.5.3.2 First aid;

9.5.3.3 Cultural sensitivity;

9.5.3.4 Behavior management; and

9.5.3.5 Physical intervention techniques.

9.5.4 All orientation and training documents must be kept on file to document the delivery of the training to each employee/volunteer.

9.6 Volunteers

9.6.1 The qualifications of volunteers must be appropriate to the duties they perform.

9.6.2 A designated employee must be assigned to supervise volunteers.

9.6.3 Any volunteer who provides services or assistance on a routine basis is subject to the same background check as employees.

9.6.4 Volunteers are not permitted to perform physical interventions.

9.7 Health

9.7.1 All prospective employees and volunteers must have, on file, the results of a general physical examination within 12 months prior to the date of employment or volunteering.

9.7.2 All prospective employees and volunteers must have, on file, evidence that they have had a medically accepted procedure for screening for tuberculosis (TB) within 3 months prior to the date of employment or volunteering.

9.7.2.1 Minimum requirements for TB testing are those currently recommended by the Centers for Disease Control and Prevention of the U.S. Department of Health and Human Services.

9.7.3 To be eligible to work in the IBSER or program, an employee or volunteer must be free from communicable disease.

9.7.4 All IBSERs shall have on file evidence of an annual vaccination against influenza for all employees and volunteers unless refused or medically contraindicated.

9.7.4.1 The provider must document and keep on file each employee’s/volunteer’s acceptance or refusal of the flu vaccine.

**History**
- *25 DE Reg. 767 (02/01/22)*
- *15 DE Reg. 1603 (05/01/12)*
- *23 DE Reg. 43 (07/01/19)*
- *25 DE Reg. 767 (02/01/22)*

##### **16 Del. Admin. Code § 3320-10.0** Infection Prevention and Control Program {#sec-3320-10.0 omnilex-key=us-de-regs-official--title-16--3320-10.0}

10.1 The IBSER shall establish and implement an infection prevention and control program which shall be based upon Centers for Disease Control and Prevention and other nationally recognized infection prevention and control guidelines.

10.1.1 The infection prevention and control program must cover all services and all areas of the IBSER, including provision of the appropriate personal protective equipment for all residents, staff and visitors.

10.2 The individual designated to lead the IBSER's infection prevention and control program must develop and implement a comprehensive plan that includes actions to prevent, identify, and manage infections and communicable diseases. The plan must include mechanisms that result in immediate action to take preventive or corrective measures that improve the IBSER's infection control outcomes.

10.3 All IBSER staff shall receive orientation at the time of employment and annual in-service education regarding the infection prevention and control program.

10.4 Specific Requirements for COVID-19

10.4.1 Before their start date, all new staff, vendors and volunteers must be tested for COVID-19 in accordance with Division of Public Health guidance.

10.4.2 All staff, vendors and volunteers must be tested for COVID-19 in a manner consistent with Division of Public Health guidance.

10.4.3 The IBSER must follow recommendations of the Centers for Disease Control and Prevention and the Division of Public Health regarding the provision of care or services to residents by staff, vendor or volunteer found to be positive for COVID-19 in an infectious stage.

10.5 The IBSER shall amend their policies and procedures to include:

10.5.1 Work exclusion and return to work protocols for staff tested positive for COVID-19;

10.5.2 Staff refusals to participate in COVID-19 testing;

10.5.3 Staff refusals to authorize release of testing results or vaccination status to the IBSER;

10.5.4 Procedures to obtain staff authorizations for release of laboratory test results to the IBSER to inform infection control and prevention strategies; and

10.5.5 Plans to address staffing shortages and IBSER demands should a COVID-19 outbreak occur.

**History**
- *25 DE Reg. 767 (02/01/22)*
- *15 DE Reg. 1603 (05/01/12)*
- *23 DE Reg. 43 (07/01/19)*
- *25 DE Reg. 767 (02/01/22)*

##### **16 Del. Admin. Code § 3320-11.0** Severability {#sec-3320-11.0 omnilex-key=us-de-regs-official--title-16--3320-11.0}

Should any section, sentence, clause or phrase of these regulations be legally declared unconstitutional or invalid for any reason, the remainder of said regulations shall not be affected thereby.

**History**
- *25 DE Reg. 767 (02/01/22)*
- *15 DE Reg. 1603 (05/01/12)*
- *23 DE Reg. 43 (07/01/19)*
- *25 DE Reg. 767 (02/01/22)*

#### **3325** Financial Capability Reporting

##### **16 Del. Admin. Code § 3325-1.0** Authority {#sec-3325-1.0 omnilex-key=us-de-regs-official--title-16--3325-1.0}

This regulation is promulgated and adopted pursuant to 29 Del.C. §7971(d).

**History**
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *19 DE Reg. 52 (07/01/15)*
- *23 DE Reg. 45 (07/01/19)*

##### **16 Del. Admin. Code § 3325-2.0** Purpose and Scope {#sec-3325-2.0 omnilex-key=us-de-regs-official--title-16--3325-2.0}

2.1 The purpose of this regulation is to detail the Department of Health and Social Services’ (DHSS) authority to monitor the financial capability of licensed long term care (LTC) providers. It details the level of information that must be provided by the licensee, or potential licensee, under various circumstances. It also defines when and in what form the Department will require the submission of audited financial statements reporting the financial position and the results of operations of facilities by accountants.

2.2 Every facility (as defined in 16 Del.C. §1102(4)) licensed to provide care for more than three (3) residents shall be subject to this regulation, with the exception of state owned/operated facilities. Facilities licensed to provide care for 3 or fewer residents licensed as Family Care Homes shall only be required to submit documentation demonstrating financial capability as required by DHSS in Section 13.0 of these regulations.

2.3 This regulation shall not prohibit, preclude or in any way limit DHSS from ordering, conducting or performing examinations of facilities under the rules and regulations of the Delaware Department of Health and Social Services and the practices and procedures of its regulations.

**History**
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *19 DE Reg. 52 (07/01/15)*
- *23 DE Reg. 45 (07/01/19)*

##### **16 Del. Admin. Code § 3325-3.0** Definitions {#sec-3325-3.0 omnilex-key=us-de-regs-official--title-16--3325-3.0}

“Accountant” means a Certified Public Accountant or Public Accountant in good standing, as those terms are defined at 24 Del.C. §102.

An “Affiliate” of, or person “Affiliated” with, means a person that directly or indirectly, through one or more intermediaries, controls, or is controlled by, or is under common control of the facility specified.

“Audited Financial Report” means and includes those items specified in subsection 7.4 of this regulation.

“Controlling Organization” means an entity that has a majority ownership interest in the licensed facility.

“DHSS” means the Delaware Department of Health and Social Services.

“Division” means the DHSS Division of Health Care Quality (DHCQ).

“Domicile” means the location of the headquarters of the business.

“Facility” means a long term care facility as defined in 16 Del.C. §1102(4) which is licensed under 16 Del.C. §1103 to provide care and services to more than three (3) residents.

"Family Care Home" means a home as defined in 16 Del.C. §1102(4).

“Financial Distress” means a finding by the Department following the analysis of an audit, complaint or data indicating that the financial condition of the facility threatens the health or safety of a resident(s) of a facility.

“Generally Accepted Accounting Principles (GAAP)” means those principles that are recognized as the standard framework of guidelines for financial accounting.

"Local Financial Institution" means a bank or other institution offering financial services with headquarters or branch offices in Delaware.

“Material Adverse Change” means a change in the financial position of the facility or the controlling organization that threatens the health or safety of a resident(s) of a facility.

“Reasonable Profit” means a net profit of 1-1.5 percent of Gross Receipts/Sales/Revenue.

**History**
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *19 DE Reg. 52 (07/01/15)*
- *23 DE Reg. 45 (07/01/19)*

##### **16 Del. Admin. Code § 3325-4.0** Requirements for the Submission of Financial Documents Upon Application for Renewal of a License. {#sec-3325-4.0 omnilex-key=us-de-regs-official--title-16--3325-4.0}

4.1 With the exception of Family Care Homes, which are addressed in Section 13.0 of these regulations, all annual applications for renewal of a license shall be submitted at least thirty (30) calendar days prior to the expiration date of the license. The application must include a transmittal letter containing:

4.1.1 The type of ownership for the facility as well as senior, subordinate and affiliated organizations, i.e. proprietorship, partnership, corporation, Subchapter S Corporation or Limited Liability Company and;

4.1.2 The place of incorporation/registration, including names and addresses for all persons/entities with a 5% or greater ownership;

4.1.3 Year-end financial statement(s) – balance sheet, income statement, and statement of cash flows for the facility (most recent year at year-end). If the year-end statement that is provided is three (3) or more months old when it is received by the Department a supplemental statement through the most recent month must be submitted. If the supplemental statement(s) is not prepared by independent accountants, it is to be attested to by the treasurer and a second officer;

4.1.4 Evidence of a surety bond in an amount equal to or greater than the sum of the previous four (4) months of all expenses as indicated on the most recent year-end profit and loss statement.

4.1.5 A copy of the Memorandum of Understanding executed by and between the principal and chief financial officer of the facility and the DHSS Cabinet Secretary, or their designee, agreeing and acknowledging any and all expenditures from this account will be at the call of and with the express written consent of DHSS for the emergency maintenance of the health, housing and welfare of the residents.

4.1.6 A list of officers with addresses;

4.1.7 Organization charts with names and titles (personnel – facility and controlling organization);

4.1.8 Organization chart (corporate structure), delineating senior, subordinate and affiliated organizations, lines of authority/ownership, and domicile;

4.1.9 Facility address (domicile), all aliases and E.I.N. (employer identification number);

4.1.10 Information on the ownership of the real estate on which the facility is located including: name of the organization, address (domicile), E.I.N and principals with 5% or greater ownership;

4.1.11 Name, address (domicile, and E.I.N. of the management entity involved in the operation of the facility, if any;

4.1.12 All items submitted separately must bear the signed certification statement: “I certify, under penalty of perjury, the attached statement is true, complete and correct”;

4.1.13 Information on the controlling organization to include:

4.1.13.1 The most recent year-end financial statements for the controlling organization;

4.1.13.2 The most recent year-end personal financial statements of the proprietors or partners if the Controlling Organization is a proprietorship or partnership; and

4.1.13.3 The most recent year-end personal financial statement for guarantors of a corporate transaction if the Controlling Organization is a proprietorship or partnership.

4.2 Any material adverse change to the facility’s financial position must be reported to the Department by the facility in writing within five (5) business days of its occurrence or discovery.

**History**
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *19 DE Reg. 52 (07/01/15)*
- *23 DE Reg. 45 (07/01/19)*

##### **16 Del. Admin. Code § 3325-5.0** Requirements for the Submission of Financial Documents Upon Application for New Facility/Change of Ownership {#sec-3325-5.0 omnilex-key=us-de-regs-official--title-16--3325-5.0}

5.1 All applications for a license for a new facility or for a change of ownership for an existing facility shall include with the application a transmittal letter to include all the items listed in subsection 4.1, except 4.1.3 and:

5.2 Transaction Documents to include:

5.2.1 Sale/Purchase Agreement

5.2.2 Closing Statement

5.2.3 Notes (must include all terms and conditions, including but not limited to balance, payment amount, payment period, interest rate and mandated ratios)

5.2.4 Mortgages (see 5.2.3)

5.2.5 Leases (Complete)

5.2.6 The above listed items must include all attachments, addendums, revisions and reference items.

5.3 Financial Documents to include:

5.3.1 Projected statement of Revenue and Expenses for thirty-six (36) months;

5.3.2 Projected statement of Revenue and Expenses converted to cash flow (for 36 months);

5.3.3 Beginning Pro Forma Balance Sheet for the first three years of operation;

5.3.4 Ending Pro Forma Balance Sheets for the first three years of operation;

5.3.5 The documents shall be prepared in a month–by-month format for 36 months.

5.3.6 Any newly established Facility without a parent, or any new or newly owned facility with a newly established parent without a financial history of at least thirty-six (36) months must provide evidence of capital availability in the name of the facility equal to four (4) months of anticipated facility expenses as evidenced on the pro forma profit and loss statement.

5.3.6.1 The capital availability shall be in the form of Cash or Surety Bond.

5.3.6.1.1 All cash and surety bonds shall be in the name of the facility and the DHCQ.

5.3.6.1.2 Further, a Memorandum of Understanding will be executed by and between the principal and Chief Financial Officer of the facility and the Director of DHCQ agreeing and acknowledging any and all expenditures from this account will be at the call of and with the express written consent, direction and supervision of the DHCQ for the emergency health, housing and welfare of the residents.

5.3.6.1.3 Said capital availability shall be maintained at a local financial institution for the first twenty-four (24) months of operation of the facility, and the facility will provide a copy of a letter from it to the local financial institution instructing it to notify DHSS immediately if the agreed upon balance is not maintained.

5.3.7 Information on the controlling organization to include:

5.3.7.1 The most recent three (3) years of audited year-end financial statements for the controlling organization;

5.3.7.2 The most recent three (3) years of audited personal financial statements for the proprietors or partners if the Controlling Organization is a proprietorship or partnership;

5.3.7.3 The most recent three (3) years of audited personal financial statements for guarantors of a corporate transaction if the Controlling Organization is a proprietorship or partnership;

5.3.7.4 If the controlling organization is an affiliation of individuals each individual shall provide certified financial statements for the most recent three (3) years, or recent financial information acceptable to DHSS on which an analysis and judgement of financial strength and capability can be determined.

5.3.8 DHSS may accept draft transaction documents and unaudited financial statements pending the receipt of executed transaction documents and audited financial statements and reserves the right to require the submission of additional information upon initial review; and

5.3.9 Additional materials which will facilitate analysis are encouraged.

5.4 Effective upon the date of purchase or change of ownership the facility will provide monthly financial information to DHSS 30 days past the month reported. All in-house prepared financial information is to include the following certification signed by the Chief Financial Officer: “All financial information provided herewith is certified to be true and correct to the best of my knowledge and belief, under penalty of perjury.” The information will include:

5.4.1 Balance sheet;

5.4.2 Profit/Loss statement;

5.4.3 Statement of cash flow; and

5.4.4 Current resident census.

5.5 Any material adverse change to the facility’s cash flow or financial position must be reported to DHSS by the facility in writing within five (5) business days of its occurrence or discovery.

**History**
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *19 DE Reg. 52 (07/01/15)*
- *23 DE Reg. 45 (07/01/19)*

##### **16 Del. Admin. Code § 3325-6.0** Resident Trust Funds {#sec-3325-6.0 omnilex-key=us-de-regs-official--title-16--3325-6.0}

6.1 Every facility that receives, holds or disburses funds belonging to the residents shall maintain and retain the below listed documentation. The documentation must be provided to DHSS upon request.

6.1.1 Copy of the current Surety Bond covering Resident Trust Funds.

6.1.2 Copies of appropriate account statements for the Fund (bank statements) for the most recent month.

6.1.3 Copies of ledger account records for each resident having funds in the account corresponding to the most recent account statement.

6.1.4 If reconciliations are performed, copies of the statement of reconciliation for the appropriate month.

6.1.5 A record of all residents for whom the facility held funds discharged from the facility during the previous twelve (12) months. For each such discharged resident the facility shall document the following:

6.1.5.1 Date of departure;

6.1.5.2 Reason for departure;

6.1.5.3 Resident balance in trust fund at date of departure;

6.1.5.4 Date and disposition of resident funds.

**History**
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *19 DE Reg. 52 (07/01/15)*
- *23 DE Reg. 45 (07/01/19)*

##### **16 Del. Admin. Code § 3325-7.0** Audited Financial Disclosure Requirement {#sec-3325-7.0 omnilex-key=us-de-regs-official--title-16--3325-7.0}

7.1 When DHSS determines that financial conditions exist which threaten the health or safety of a resident(s) in a facility, DHSS may require the facility to submit certified in-house financial statements within 15 days of request and an audited financial report prepared by an accountant within 60 days. The foregoing time frames may be extended by DHSS upon written request.

7.2 Conditions which may prompt DHSS to require audited financial disclosure include but are not limited to:

7.2.1 Substandard Quality of Care.

7.2.2 A material adverse change to the facility’s financial position.

7.2.3 Facility/Equipment maintenance inadequacies.

7.2.4 Repeated or frequent payroll interruptions or shortages.

7.2.5 Confirmed delinquencies on invoices from suppliers or attendant court actions.

7.2.6 Personnel shortages (understaffing and /or under-qualification of staff).

7.2.7 Delinquent tax payments.

7.2.8 Bankruptcy, reorganization or closure.

7.3 Audits may initially be transmitted to DHSS by electronic means. The electronic submission must be followed by an original, bound, signed audit, prepared by an accountant.

7.4 Contents of an Audited Financial Report:

7.4.1 The audited financial report shall indicate the current financial position of the facility and the results of its operations, cash flows and changes in capital. The report shall conform to GAAP practices. It shall include:

7.4.1.1 Report of accountant;

7.4.1.2 Balance sheet reporting assets, liabilities, and capital;

7.4.1.3 Statement of operations;

7.4.1.4 Statement of cash flows;

7.4.1.5 Statement of changes in capital; and

7.4.1.6 Notes to financial statements. These notes shall be those required by GAAP.

**History**
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *19 DE Reg. 52 (07/01/15)*
- *23 DE Reg. 45 (07/01/19)*

##### **16 Del. Admin. Code § 3325-8.0** Qualifications of Accountants {#sec-3325-8.0 omnilex-key=us-de-regs-official--title-16--3325-8.0}

In order for DHSS to recognize a person or firm as a qualified accountant, the person or firm must be in good standing with the Delaware Board of Accountancy.

**History**
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *19 DE Reg. 52 (07/01/15)*
- *23 DE Reg. 45 (07/01/19)*

##### **16 Del. Admin. Code § 3325-9.0** Consolidated Financial Statements {#sec-3325-9.0 omnilex-key=us-de-regs-official--title-16--3325-9.0}

9.1 A facility may make written application to DHSS for approval to file consolidated financial statements in lieu of separate annual financial statements if the facility is part of a group. Consolidated statements must meet the following requirements:

9.1.1 Amounts shown on the consolidated audited financial report shall be shown on the worksheet;

9.1.2 Amounts for each separately licensed facility subject to this section shall be stated separately;

9.1.3 Non-facility operations may be shown on the worksheet on a consolidated or individual basis;

9.1.4 Explanations of consolidating and eliminating entries shall be included;

9.1.5 A reconciliation of any differences between the amounts shown in the individual facility columns of the worksheet and comparable amounts shown on the annual statements of the facilities shall be included;

9.1.6 Notes on each facility included in a consolidated financial statement will be included with the notes of the consolidation with each separate facility clearly identified; and

9.1.7 Any statements completed in excess of 30 days after the closing of the audited period will be accompanied by an in-house prepared financial statement for each separately licensed facility. The period covered by the in-house statement will be from the audit end-date through the most recent facility monthly statement. The statement will be dated and certified as correct by the signature of the Chief Financial Officer.

**History**
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *19 DE Reg. 52 (07/01/15)*
- *23 DE Reg. 45 (07/01/19)*

##### **16 Del. Admin. Code § 3325-10.0** Scope of Audit and Report By Accountant {#sec-3325-10.0 omnilex-key=us-de-regs-official--title-16--3325-10.0}

Financial statements furnished pursuant to subsection 7.4 shall be examined by the accountant. The audit of the facility’s financial statements shall be conducted in accordance with generally accepted auditing standards. The accountant should obtain an understanding of internal control sufficient to plan the audit.

**History**
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *19 DE Reg. 52 (07/01/15)*
- *23 DE Reg. 45 (07/01/19)*

##### **16 Del. Admin. Code § 3325-11.0** Notification of Adverse Financial Condition {#sec-3325-11.0 omnilex-key=us-de-regs-official--title-16--3325-11.0}

11.1 A facility that is required to furnish an annual audited financial report shall require the accountant to report, in writing, within five (5) business days to the board of directors or its audit committee any determination by the accountant that the facility has materially misstated its financial condition to DHSS. A facility that receives a report pursuant to this paragraph shall forward a copy of the report to DHSS within five (5) business days of receipt of the report accompanied by any amended or corrected audit generated as a result of the misstatement.

11.2 No accountant shall be liable in any manner to any person for any statement made in connection with the above paragraph if the statement is made in good faith in compliance with Section 10.0.

11.3 If the accountant, subsequent to the date of the audited financial report filed pursuant to this regulation, becomes aware of facts that might have affected his or her report, DHSS notes the obligation of the accountant to take such action as prescribed by the Delaware Board of Accountancy.

**History**
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *19 DE Reg. 52 (07/01/15)*
- *23 DE Reg. 45 (07/01/19)*

##### **16 Del. Admin. Code § 3325-12.0** Conduct of Facility in Connection with the Preparation of Required Reports and Documents {#sec-3325-12.0 omnilex-key=us-de-regs-official--title-16--3325-12.0}

12.1 No director or officer of a facility shall, directly or indirectly:

12.1.1 Make or cause to be made a materially false or misleading statement to an accountant in connection with any audit, review or communication required under this regulation; or

12.1.2 Fail to accurately report any material fact or information to the accountant in connection with any audit or review required under this regulation; or

12.1.3 Directly or indirectly coerce, manipulate, mislead or fraudulently influence any accountant engaged in the performance of an audit pursuant to this regulation that results in the submission of materially misleading financial statements.

**History**
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *19 DE Reg. 52 (07/01/15)*
- *23 DE Reg. 45 (07/01/19)*

##### **16 Del. Admin. Code § 3325-13.0** Facilities With Three or Fewer Residents/Family Care Homes {#sec-3325-13.0 omnilex-key=us-de-regs-official--title-16--3325-13.0}

13.1 Facilities licensed to house 3 or fewer residents are private family residences. As such, they have no corporate structure or accounting procedures by which the Division is able to assess their financial capability.

13.2 An annual application for renewal of a license shall be submitted at least thirty (30) calendar days prior to the expiration date of the current license.

13.3 The financial capability of Family Care Homes will be measured by an analysis of the license-holder’s credit worthiness through credit checks at the discretion of DHSS. These will be conducted by a nationally recognized credit check agency at the time of license renewal, inception or at the discretion of DHSS.

13.3.1 To facilitate this process it will be necessary for every license-holder to submit identification information including full name, address, date of birth and Social Security Identification number annually on their application for a license or license renewal.

**History**
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *19 DE Reg. 52 (07/01/15)*
- *23 DE Reg. 45 (07/01/19)*

##### **16 Del. Admin. Code § 3325-14.0** Enforcement and Oversight Authority {#sec-3325-14.0 omnilex-key=us-de-regs-official--title-16--3325-14.0}

14.1 DHSS is authorized to impose the below listed actions to monitor the financial capability of a facility it has determined to be in financial distress. Noncompliance with any imposed action may result in the imposition of civil penalties or other remedies for compliance as authorized by 16 Del.C., Chapter 11, Subchapter I.

14.1.1 Monthly submission within thirty (30) calendar days of the end of the month of monthly financial information from the facility to include:

14.1.1.1 Balance Sheet, Profit and Loss Statement, Statement of Cash Flows, Census Information; and

14.1.1.2 Certification by the Chief Financial or Corporate Officer with the following statement: “All financial information provided herein is certified to be true and correct to the best of my knowledge and belief, under penalty of perjury.”

14.1.2 Submission of monthly certifications from the facility that all required licenses, taxes and insurances are paid-to-date, are current and in effect.

14.1.3 Attendance of facility and corporate staff at periodic meetings with DHSS to discuss past performance and expectations for future performance, to include:

14.1.4 Requirement of a written plan from the facility indicating how it will return to profitability.

14.1.5 Reclassification of the facility license from annual to provisional status.

14.1.6 Requirement that the Controlling Organization (if any) of the facility provide a written assurance to DHSS that the Controlling Organization will step in to provide financial support to ensure that the residents continue to receive quality care. The written assurance is to include text as provided by DHSS.

14.1.7 Query courts of local jurisdiction for pending or past legal actions or judgments against the facility by suppliers and/or government agencies

14.1.8 Notification to The Centers for Medicare and Medicaid Services of the facility’s financial difficulty (federally certified facilities).

14.1.9 The issuance of an emergency order temporarily transferring the management of the facility to another qualified entity in cases where the physical health or safety of a resident(s) is in imminent risk.

14.1.9.1 The terms and conditions of the emergency order including costs of implementation are to be determined by DHSS. The terms and conditions of the emergency order are effective until DHSS conducts an administrative hearing to determine the facility management’s ongoing licensure status, which hearing must be conducted within 60 days from the date of the issuance of the order unless the facility requests a continuance of the hearing date. At the conclusion of the hearing DHSS will make a final determination regarding the costs of implementation of such management and the facility’s ongoing licensure status.

14.1.9.2 Any costs associated with the actions taken in subsection 14.1.9.1 will be paid via the reserve fund established under subsection 5.3.5.

14.1.10 Require written notification from the facility, to each individual resident and, if known, a family member or legal representative that the financial capability of the facility is under review by DHSS. The notification must be written in a language and manner that is easily understood by the individual resident and/or individual resident’s representative.

14.1.10.1 Provide a copy of the notice to the DHSS; the State Long Term Care Ombudsman; managed care organization (MCO), as appropriate; any DHSS agency involved in the resident placement in the facility, including Adult Protective Services; and the protection and advocacy agency as defined in 16 Del.C. §1102 if the resident is an individual with a developmental disability or mental illness.

**History**
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *19 DE Reg. 52 (07/01/15)*
- *23 DE Reg. 45 (07/01/19)*

##### **16 Del. Admin. Code § 3325-15.0** Confidentiality of Facility Financial Records {#sec-3325-15.0 omnilex-key=us-de-regs-official--title-16--3325-15.0}

15.1 DHSS shall maintain the financial documents submitted by facilities in a secure and confidential manner.

15.2 DHSS will consider financial documents submitted pursuant to these regulations as exempt from public disclosure consistent with 29 Del.C. §10002(l)(2) and 16 Del.C. §1104(e).

**History**
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *19 DE Reg. 52 (07/01/15)*
- *23 DE Reg. 45 (07/01/19)*

##### **16 Del. Admin. Code § 3325-16.0** Severability Provision {#sec-3325-16.0 omnilex-key=us-de-regs-official--title-16--3325-16.0}

If any section or portion of a section of this regulation or its applicability to any person or circumstance is held invalid by a court, the remainder of the regulation or the applicability of the provision to other persons or circumstances shall not be affected.

**History**
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *23 DE Reg. 45 (07/01/19)*
- *19 DE Reg. 52 (07/01/15)*
- *23 DE Reg. 45 (07/01/19)*

#### **3330** Regulations Governing Dialysis Centers

##### **16 Del. Admin. Code § 3330-1.0** Purpose {#sec-3330-1.0 omnilex-key=us-de-regs-official--title-16--3330-1.0}

Delaware Department of Health and Social Services adopts these regulations pursuant to the authority vested by 16 Del.C. §122(3)(aa). These regulations establish standards with respect to the operation and emergency energy sources of dialysis centers.

**History**
- *25 DE Reg. 769 (02/01/22)*
- *22 DE Reg. 853 (04/01/19)*
- *25 DE Reg. 769 (02/01/22)*

##### **16 Del. Admin. Code § 3330-2.0** Definitions {#sec-3330-2.0 omnilex-key=us-de-regs-official--title-16--3330-2.0}

The following words and terms, when used in this regulation, shall have the following meaning unless the context clearly indicates otherwise:

“Administrator” means a person who is delegated the responsibility for the implementation and proper application of policies, programs, and services established for the dialysis center.

“Adverse Event” means an unintended consequence or injury to resulting from or contributed to by the care, or lack thereof, that requires additional investigation, monitoring, treatment, hospitalization, or results in death.

“All-Hazards Approach” means an integrated approach to emergency preparedness that focuses on identifying hazards and developing emergency preparedness capacities and capabilities that can address those in addition to a wide spectrum of emergencies or disasters.

“Department” means the Department of Health and Social Services.

“Dialysis Center” means an independent or hospital-based unit approved and licensed to furnish outpatient dialysis services (maintenance dialysis services, home dialysis training and support services or both) directly to end stage renal disease (ESRD) patient(s).

“Disaster” means an event that can affect the facility internally as well as the staff, patients, community or geographic area by causing adverse physical, social, psychological, economic or political effects that challenges the ability to respond rapidly and effectively.

“Dummy Drip Chamber” means a fluid-filled chamber used to bypass the dialysis machines air detectors.

“Emergency” means an event that can affect the facility internally as well as the staff, patients, community or geographic area by causing adverse physical, social, psychological, economic or political effects that challenges the ability to respond rapidly and effectively.

“Emergency Preparedness Program” means the dialysis center’s comprehensive approach to meeting the health, safety and security needs of the facility, staff, patient population and community prior to, during and after an emergency or disaster. The program encompasses four core elements:

“ESRD” means end stage renal disease.

“Facility” means the dialysis center.

“Full-time” means the number of hours the dialysis center is open or requires for full-time employment.

“Hazard Vulnerability Assessment” means a comprehensive process the dialysis center uses to assess and document potential hazards that are likely to impact their geographical region, community, facility and patient population and identify gaps and challenges that should be considered and addressed in developing the emergency preparedness program.

“Home Dialysis Service” means dialysis performed at the patient’s residence by an ESRD patient or caregiver who has completed a dialysis center’s required training.

“Incompetence” means the inability to function at a safe level or to provide care that is consistent with standards of practice.

“Interdisciplinary Team” means a team, which at a minimum consists of the patient or patient’s designee (if the patient chooses), a registered nurse, a physician treating the patient for end stage renal disease, a social worker and a dietitian.

“ISO” means International Organization for Standardization.

“Long Term Care Facility” means a facility licensed pursuant to Title 16, Chapter 11 of the Delaware Code.

“Misconduct” means behavior that is professionally unethical, immoral and/or illegal.

“Modality” means the different treatment options and settings for patients with end stage renal disease, for example, in-center dialysis, home hemodialysis, peritoneal dialysis, self-care dialysis, nocturnal dialysis, and transplantation.

“Modification of Ownership and Control” means a change of ownership or transfer of responsibility for the dialysis center’s operation.

“Negligence” means an act or omission of care that deviates from the accepted standard of care and can lead to illness, disability or death.

“Non-physician Provider” means a person currently licensed as an advanced practice nurse pursuant to Title 24, Chapter 17 of the Delaware Code, or a person currently licensed as a physician’s assistant pursuant to Title 24, Chapter 19 of the Delaware Code.

“Patient” means a person who receives health care services from a dialysis center.

“Patient Care Technician” means any person who provides direct care to patients and who is not classified as another professional (i.e. registered nurse, dietitian, social worker, etc.).

“Physician” means a person currently licensed as a physician by Title 24, Chapter 17 of the Delaware Code.

“Plan of Correction” means a written document that includes specific measures to correct identified problems or areas of concern; identifies strategies for implementing system improvements; and includes outcome measures to indicate the effectiveness of system improvements in reducing, controlling or eliminating identified problem areas.

“Quality Assessment and Performance Improvement” (QAPI) means an ongoing program that measures, analyzes, and tracks quality indicators related to improving health outcomes and patient care emphasizing a multidisciplinary approach. The program implements plans and evaluates the implementation until resolution is achieved.

“Registered Nurse” means a person currently licensed as a registered nurse pursuant to Title 24, Chapter 19 of the Delaware Code.

“Reprocessing” means the process of cleaning and the installation of germicide into a dialyzer.

“Reuse” means the clinical use of a reprocessed dialyzer.

"Serious Injury" means physical injury that creates a substantial risk of death, or that causes serious disfigurement, prolonged impairment of health or prolonged loss or impairment of the function of any bodily organ.

**History**
- *25 DE Reg. 769 (02/01/22)*
- *22 DE Reg. 853 (04/01/19)*
- *25 DE Reg. 769 (02/01/22)*

##### **16 Del. Admin. Code § 3330-3.0** Licensure Requirements and Procedures {#sec-3330-3.0 omnilex-key=us-de-regs-official--title-16--3330-3.0}

3.1 General Requirements

3.1.1 No person shall establish, conduct or maintain in this State any dialysis center without first obtaining a license from the Department.

3.1.2 A license issued hereunder shall be subject, at any time, to revision or revocation by the State.

3.1.3 A license is not transferable from person to person, entity to entity or from one location to another.

3.1.4 The license shall be posted in a conspicuous place on the licensed premises, at or near the entrance in a manner which is plainly visible and easily read by the public.

3.1.5 Separate licenses are required for dialysis centers maintained in separate locations, even though operated under the same management.

3.1.6 Any dialysis center that undergoes a modification of ownership and control is required to re-apply as a new dialysis center and must meet the current design and construction standards recognized by the Department.

3.1.7 The submission of an application is in no way a guarantee that the completed application will be accepted or that a license will be issued by the Department.

3.1.8 Patients shall not be admitted to a dialysis center until a license has been issued.

3.1.9 The dialysis center shall advise the Department in writing at least 30 calendar days prior to closure of the dialysis center and voluntary surrender of a license.

3.1.10 The dialysis center shall notify the Department in writing at least 30 calendar days prior to adding/removing a service or modifying the station count.

3.2 Application Process

3.2.1 All persons or entities wanting to apply to open a dialysis center shall submit to the Department the following information:

3.2.1.1 A Statement of Intent describing the services to be offered at the dialysis center;

3.2.1.2 A completed application for licensure;

3.2.1.3 The names, addresses and types of facilities previously and currently owned or managed by the applicant;

3.2.1.4 Identity of:

3.2.1.4.1 Each officer and director of the corporation, if the entity is organized as a corporation;

3.2.1.4.2 Each general partner or managing member, if the entity is organized as an unincorporated entity;

3.2.1.4.3 The governing body; and

3.2.1.4.4 Any officers/directors, partners, or managing members, or members of a governing body who have a financial interest in a licensee’s operation or related business.

3.2.1.5 Proof of not-for-profit status, if claiming tax-exempt status;

3.2.1.6 Disclosure of any officer, director, partner, employee, managing member or member of the governing body with a felony criminal record;

3.2.1.7 Name of the director and the person designated to act in the absence of the director;

3.2.1.8 A list of management personnel, including credentials;

3.2.1.9 A plan for providing orientation, continuing education, and training for personnel or contractors during the first year of operation;

3.2.1.10 Policy and procedure manuals; and

3.2.1.11 Any other information required by the Department.

3.3 Issuance of Licenses

3.3.1 Initial License

3.3.1.1 An initial license shall be issued for a period of three (3) calendar months to those applicants who meet the requirements for licensure.

3.3.1.2 Once an initial license has been issued, the dialysis center may begin to offer services to patients.

3.3.1.3 All dialysis centers shall have an on-site survey, conducted by the Department, during the first three (3) calendar months of operation.

3.3.1.3.1 If the dialysis center meets the licensure requirements, as contained within these regulations, is in operation and caring for patients at the time of the initial on-site survey, an annual license for the remainder of the licensure year will be issued.

3.3.1.3.2 Facilities that, at the time of the on-site survey, do not meet the definition of a dialysis center or that are not in substantial compliance with these regulations will not be granted a license.

3.3.1.4 An initial license may not be renewed.

3.3.2 Provisional License

3.3.2.1 A provisional license shall be granted, for a period of less than one year, to all dialysis centers that:

3.3.2.1.1 Are not in substantial compliance with these rules and regulations; or

3.3.2.1.2 Fail to renew a license within the timeframe prescribed by these regulations.

3.3.2.2 The Department shall designate the conditions and the time period under which a provisional license is issued.

3.3.2.3 A provisional license may not be renewed unless a plan of correction for coming into substantial compliance with these rules and regulations has been approved by the Department and implemented by the dialysis center.

3.3.2.4 A license will not be granted pursuant to subsection 3.3.2 after the provisional licensure period to any dialysis center that is not in substantial compliance with these rules and regulations.

3.3.3 Annual License

3.3.3.1 An annual license shall be granted, for a period of one year (12 months) to all dialysis centers which are and remain in substantial compliance with these rules and regulations.

3.3.3.2.1 Modified to a provisional license;

3.3.3.2.2 Suspended;

3.3.3.2.3 Revoked; or

3.3.3.2.4 Surrendered prior to the expiration date.

3.3.3.3 All applications for renewal of licenses shall be filed with the Department at least thirty (30) days prior to the expiration date of the license.

3.3.3.4 Dialysis centers which have not been inspected/surveyed during a licensure year may apply for, and be issued, a new license until an inspection/survey is completed.

3.3.3.5 A license may not be issued to a dialysis center which is not in substantial compliance with these regulations or whose deficient practices present an immediate threat to the health and safety of its patients.

3.4 Disciplinary Sanctions

3.4.1 The Department may impose sanctions singly or in combination when it finds a licensee or former licensee has:

3.4.1.1 Violated any of these regulations;

3.4.1.2 Failed to submit a reasonable timetable for correction of deficiencies;

3.4.1.3 Failed to correct deficiencies in accordance with a timetable submitted by the applicant and agreed upon by the Department;

3.4.1.4 Exhibited a pattern of cyclical deficiencies which extends over a period of 2 or more years;

3.4.1.5 Engaged in any conduct or practices detrimental to the welfare of the patients;

3.4.1.6 Exhibited incompetence, negligence or misconduct in operating the dialysis center in providing services to patients;

3.4.1.7 Mistreated or abused patients cared for by the dialysis center;

3.4.1.8 Violated any statutes relating to medical assistance or Medicare reimbursement for those facilities who participate in those programs; or

3.4.1.9 Refused to allow the Department access to the dialysis center or records for the purpose of conducting inspections/surveys/investigations as deemed necessary by the Department.

3.4.2 Disciplinary sanctions include any of the following:

3.4.2.1 Permanent revocation of a license which extends to:

3.4.2.1.1 The dialysis center;

3.4.2.1.2 Any owner;

3.4.2.1.3 Officers/directors, partners, managing members or members of a governing body who have financial interest of 5% or more in the dialysis center; or

3.4.2.1.4 Corporation officers.

3.4.2.2 Suspension of a license;

3.4.2.3 A letter of reprimand;

3.4.2.4 Placement on provisional status with the following requirements:

3.4.2.4.1 Report regularly to the Department upon the matters which are the basis of the provisional status;

3.4.2.4.2 Limit practice to those areas prescribed by the Department; and/or

3.4.2.4.3 Suspend operations.

3.4.2.5 Refusal of a license;

3.4.2.6 Refusal to renew a license;

3.4.2.7 Other disciplinary action as appropriate.

3.4.3 The Department may request the Superior court impose a civil penalty of not more than $10,000 for a violation of these regulations. Each day a violation continues constitutes a separate violation.

3.4.3.1 In lieu of seeking a civil penalty, the Department, in its discretion, may impose an administrative penalty of not more than $10,000 for a violation of these regulations. Each day constitutes a separate violation.

3.4.3.2 In determining the amount of any civil or administrative penalty imposed, the Court or the Department shall consider the following factors:

3.4.3.2.1 The seriousness of the violation, including the nature, circumstances, extent and gravity of the violation and the threat or potential threat to the health or safety of the patient;

3.4.3.2.2 The history of violations committed by the person or the person’s affiliate, agent, employee or controlling person;

3.4.3.2.3 The efforts made by the dialysis center to correct the violation(s);

3.4.3.2.4 Any misrepresentation made to the Department; and

3.4.3.2.5 Any other matter that affects the health, safety or welfare of a patient.

3.4.4 Imposition of a disciplinary action

3.4.4.1 Before any disciplinary action is taken the following shall occur:

3.4.4.1.1 The Department shall give 20 calendar days written notice to the holder of the license, setting forth the reasons for the determination;

3.4.4.1.2 The disciplinary action shall become final 20 calendar days after the mailing of the notice unless the licensee, within such 20-calender-day period, shall give written notice of the dialysis centers desire for a hearing;

3.4.4.1.3 If the licensee give such notice, the dialysis center shall be given a hearing before the Secretary of the Department or his/her designee and may present such evidence as may be proper;

3.4.4.1.4 The Secretary of the Department or his/her designee shall make a determination based upon the evidence presented.

3.4.4.1.5 A written copy of the determination and the reasons upon which it is based shall be sent to the dialysis center;

3.4.4.1.6 The decision shall become final 20 calendar days after the mailing of the determination letter unless the licensee, within the 20-calender-day period, appeals the decision to the appropriate court of the State.

3.4.5 Order to immediately suspend a license

3.4.5.1 In the event the Department identifies activities which the Department determines present an immediate jeopardy or imminent danger to the public health, welfare and safety requiring emergency action, the Department may issue an order temporarily suspending the licensee’s license, pending a final hearing on the complaint. No order temporarily suspending a license shall be issued by the Department, with less than 24 hours prior written or oral notice to the licensee or the licensee’s attorney so that the licensee may be heard in opposition to the proposed suspension. An order of temporary suspension under this section shall remain in effect for a period not longer than 60 calendar days from the date of the issuance of said order, unless the suspended licensee requests a continuance of the date for the final hearing before the Department. If a continuance is requested, the order of temporary suspension shall remain in effect until the Department has rendered a decision after the final hearing.

3.4.5.2 The licensee, whose license has been temporarily suspended, shall be notified forthwith in writing. Notification shall consist of a copy of the deficiency report and the order of temporary suspension pending a hearing and shall be personally served upon the licensee or sent by mail, return receipt requested, to the licensee’s last known address.

3.4.5.3 A licensee whose license has been temporarily suspended pursuant to this section may request an expedited hearing. The Department shall schedule the hearing on an expedited basis provided that the Department receives the licensee’s written request for an expedited hearing within 5 calendar days from the date on which the licensee received notification of the Department’s decision to temporarily suspend the licensee’s license.

3.4.5.4 As soon as possible, but in no event later than 60 calendar days after the issuance of the order of temporary suspension, the Department shall convene a hearing on the reasons for suspension. In the event that a licensee, in a timely manner, requests an expedited hearing, the Department shall convene within 15 calendar days of the receipt by the Department of such a request and shall render a decision within 30 calendar days.

3.4.5.5 In no event shall an order of temporary suspension remain in effect for longer than 60 calendar days unless the suspended licensee requests an extension of the order of temporary suspension pending a final decision of the Department. Upon a final decision of the Department, the order of temporary suspension may be vacated in favor of the disciplinary action ordered by the Department.

3.5 Application for licensure after revocation or voluntary surrender of a license in avoidance of revocation action

3.5.1 The application for license after termination of rights to provide services shall follow the procedure for the initial licensure application.

3.5.2 In addition to the initial licensure application, the dialysis center must also submit and obtain approval of a detailed plan of correction regarding how the dialysis center intends to correct the deficient practices that led to the original termination action. Submission of evidence supporting compliance with the plan of correction and cooperation with Department monitoring during initial licensure status is required for reinstatements to full licensure status.

3.5.3 Upon successful completion of the initial licensure period, the dialysis center will be granted a provisional license for a period of no more than 1 year. The provisional period will be identified by the Department after having considered the circumstances that created the original action for license revocation.

3.5.4 A license will be granted to the dialysis center after the provisional licensure period if:

3.5.4.1 The dialysis center has remained in compliance with these rules and regulations; and

3.5.4.2 The dialysis center fulfilled the expectations of the detailed plan of correction that was created to address the deficient practices that gave rise to the license termination action.

3.5.5 A license will not be granted after the provisional licensure period to any dialysis center that is not in compliance with these rules and regulations.

3.6 Modification of Ownership and Control (MOC)

3.6.1 Any proposed MOC must be reported to the Department in writing a minimum of 30 calendar days prior to the change.

3.6.2 A MOC occurs whenever the ultimate legal authority for the responsibility of the dialysis center’s operation is transferred.

3.6.3 A MOC voids the current license in possession of the dialysis center.

3.6.4 A MOC will be treated as an initial license and the dialysis center must meet the current design and construction standards recognized by the Department.

3.6.5 A MOC may include but is not limited to:

3.6.5.1 Transfer of the dialysis center’s legal title;

3.6.5.2 Transfer of the full ownership rights;

3.6.5.3 Transfer of the majority interest;

3.6.5.4 Transfer of ownership interest that results in the owner with the majority interest becoming a minority interest owner;

3.6.5.5 Transfer or re-organization that results in an additional majority interest that is equal in ownership rights;

3.6.5.6 Transfer resulting in a measurable impact upon the operational control of the dialysis center;

3.6.5.7 Dissolution of any partnership that owns a controlling interest in the dialysis center;

3.6.5.8 Merger of a dialysis center owner (a corporation) into another corporation where, after the merger, the owner’s shares of capitol stock are cancelled; or

3.6.5.9 The consolidation of a corporate dialysis center owner with one or more corporations.

3.6.6 Transactions which do not constitute an MOC include, but are not limited to the following:

3.6.6.1 Changes in the membership of a corporate board of directors or board of trustees;

3.6.6.2 Two or more corporations merge and the originally licensed corporation survives;

3.6.6.3 Changes in the membership of a non-profit corporation; or

3.6.6.4 Corporate stock transfers or sales that do not result in a transfer of interest or ownership.

3.6.7 Applications for licensure, as a result of an MOC must include a description of:

3.6.7.1 Any actual or anticipated change in the health care services provided before the MOC;

3.6.7.2 Any actual or anticipated change in staff, including the composition of staff;

3.6.7.3 Any actual or anticipated change in the policies and procedures; and

3.6.7.4 Any change in the manner of delivery of health care services.

3.7 Fees. Fees shall be in accordance with 16 Del.C. §122(3)aa.

3.8 Inspection. A representative of the Department shall periodically inspect every dialysis center for which a license has been issued under this chapter. Inspections by authorized representatives of the Department may occur at any time and may be scheduled or unannounced.

**History**
- *25 DE Reg. 769 (02/01/22)*
- *22 DE Reg. 853 (04/01/19)*
- *25 DE Reg. 769 (02/01/22)*

##### **16 Del. Admin. Code § 3330-4.0** Governing Body {#sec-3330-4.0 omnilex-key=us-de-regs-official--title-16--3330-4.0}

4.1 Each dialysis center shall have an identified, organized governing body (governing authority, owner or person(s) designated by the owner) fully responsible for the organization, management, control, and operation of the facility.

4.2 The governing body responsibilities include, but are not limited to:

4.2.1 Appointing an administrator in writing;

4.2.1.1 The administrator exercises the responsibility for the management of the dialysis center and the provision of dialysis services, including but not limited to:

4.2.1.1.1 Maintenance of sound fiscal operations;

4.2.1.1.2 The relationship with the ESRD Network 4; and

4.2.1.1.3 Allocation of necessary staff and resources for the dialysis center’s quality assessment and performance improvement program.

4.2.2 Appointing a qualified medical director (refer to subsection 5.2) in writing;

4.2.3 Appointing members of the medical and clinical staff, ensuring their competence and delineating their job responsibilities;

4.2.4 Ensuring all staff, including the medical director and medical staff, have appropriate orientation to the dialysis center and their work responsibilities;

4.2.5 Ensuring an adequate number of qualified personnel are present in the dialysis center whenever patients are undergoing dialysis;

4.2.6 Ensuring the registered nurse, social worker and dietitian of the interdisciplinary team are available to meet the patients’ clinical needs;

4.2.7 Offering opportunities for continuing education and related development activities for all employees;

4.2.8 Establishing, adopting, implementing, and enforcing written policies and procedures for the total operation of and all services provided by the dialysis center;

4.2.9 Documentation of annual review and evaluation of the dialysis center policies and services;

4.2.10 Ensuring that all services, whether furnished directly or under contract, are provided in a safe and effective manner that permits the facility to comply with all applicable rules and standards;

4.2.11 Conducting meetings, when the governing body is more than one person, at least annually and maintaining written minutes of the meetings;

4.2.12 Adopting governing body and medical staff bylaws for the orderly development and management of the dialysis center;

4.2.12.1 Bylaws shall be reviewed annually by the governing body and so dated. Revisions shall be completed as necessary.

4.2.13 Ensuring a physical environment that protects the health and safety of patients, personnel, and the public;

4.2.14 Ensuring that all equipment utilized by dialysis center staff or by patients is properly used and maintained per manufacturer’s recommendations;

4.2.15 Adopting, implementing and enforcing policies and procedures related to emergency planning and disaster preparedness. The governing body shall review the dialysis center’s emergency preparedness plan, and associated policies and procedures at least annually;

4.2.16 Ensuring there is a quality assessment and performance improvement (QAPI) program to evaluate the provision of patient care. The governing body shall review and monitor QAPI activities quarterly;

4.2.17 Implementing an internal grievance process for patients to file an oral or written grievance with the dialysis center.

4.2.17.1 The dialysis center must ensure that there will be no reprisal or denial of services for any patient or patient representative that files a grievance.

4.2.17.2 The grievance process must include:

4.2.17.2.1 The procedure to submit a grievance;

4.2.17.2.2 Timeframes for the review of the grievance; and

4.2.17.2.3 An explanation of how the patient or patient representative will be informed of the steps taken to resolve the grievance.

4.2.18 Ensuring that all staff follow the dialysis center’s involuntary discharge and transfer policies.

4.2.19 Ensuring emergency coverage;

4.2.19.1 The dialysis center must:

4.2.19.1.1 Provide patients and staff with written instructions for obtaining emergency medical care;

4.2.19.1.2 Have a written plan for physician coverage and contact numbers to be called for emergencies;

4.2.19.1.3 Have an agreement with a hospital that can promptly provide inpatient care, routine and emergency services which is available 24 hours a day, 7 days a week.

4.3 The governing body shall provide for full disclosure of ownership to the Department.

**History**
- *25 DE Reg. 769 (02/01/22)*
- *22 DE Reg. 853 (04/01/19)*
- *25 DE Reg. 769 (02/01/22)*

##### **16 Del. Admin. Code § 3330-5.0** Administration/Personnel {#sec-3330-5.0 omnilex-key=us-de-regs-official--title-16--3330-5.0}

5.1 All dialysis center staff (whether employees or contractors) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients.

5.2 The medical director must:

5.2.1 Be a physician;

5.2.2 Be board-certified in internal medicine, pediatrics, nephrology or pediatric nephrology by a professional board;

5.2.3 Have completed a board-approved training program in nephrology; and

5.2.4 Have at least 12-months of experience providing care to patients receiving dialysis.

5.3 The medical director shall have the overall authority and responsibility for the daily operation and management of the dialysis center.

5.4 The medical director shall be accountable to the governing body for the quality of medical care provided to patients.

5.5 The medical director shall be responsible for the direction, provision and quality of medical care.

5.6 The authority, duties and responsibilities of the medical director shall be defined in writing and shall include but not be limited to:

5.6.1 Program planning, budgeting, management and program evaluation;

5.6.2 Development and approval of the policies and procedures manual;

5.6.3 Reviewing policies and procedures at least annually, and reporting, in writing, to the governing body on the review;

5.6.4 Staff education, training and performance;

5.6.5 Ensuring all individuals, including attending physicians and non-physician providers, providing patient care adhere to all policies and procedures pertaining to patient admissions/discharge/transfers, patient care, infection control and safety;

5.6.6 Maintenance of the dialysis center’s compliance with federal and state licensure regulations and standards;

5.6.7 An ongoing QAPI program;

5.6.8 Documentation of complaints relating to the conduct or actions by employees/contractors/medical staff and action taken secondary to the complaints; and

5.6.9 Conducting or supervising the resolution of complaints received from patients/patient representatives regarding the delivery of care or services.

5.7 The medical director shall designate, in writing, a person who meets the medical director qualifications to act in the absence of the medical director.

5.8 The dialysis center shall advise the Department in writing within 15 calendar days following any change in the designation of the medical director.

5.9 Supervision of clinical services

5.9.1 The governing body shall appoint, in writing, a full-time employee of the facility as the nurse manager.

5.9.2 The nurse manager shall be responsible for implementing, coordinating and assuring quality of patient care services at only one (1) dialysis center.

5.9.3 The nurse manager shall:

5.9.3.1 Be a registered nurse with at least:

5.9.3.1.1 One (1) year of full-time experience in clinical nursing;

5.9.3.1.2 Six (6) months of experience providing maintenance dialysis; and

5.9.3.1.3 Six (6) months experience in maintenance dialysis supervision/administration.

5.9.3.2 Provide general supervision and direction of the services offered by the dialysis center.

5.9.4 The medical director shall designate, in writing, a person who meets the nurse manager qualifications to act in the absence of the nurse manager.

5.9.5 The dialysis center shall advise the Department in writing within 15 calendar days following any change in the designation of the nurse manager.

5.10 Contract services

5.10.1 The dialysis center maintains responsibility for all services provided to the patient.

5.10.2 Services provided by the dialysis center through arrangements with a contractor agency or individual shall be set forth in a written contract which clearly specifies:

5.10.2.1 The services to be provided by the contractor;

5.10.2.2 The necessity to conform to all dialysis center policies;

5.10.2.3 The procedure for annual assurance of clinical competence of all individuals utilized under contract;

5.10.2.4 The procedure for supervision of services of the contracted individuals; and

5.10.2.5 The frequency for contract renewal.

5.10.3 The dialysis center must ensure that personnel and services contracted meet the requirements specified in these regulations for dialysis center personnel and services.

5.11 Medical Staff

5.11.1 Members of the medical staff may include physicians and non-physician practitioners with training or demonstrated experience in the care of patients with end stage renal disease.

5.11.2 All members of the dialysis center medical staff must be:

5.11.2.1 Individually credentialed to ensure the individual is deemed qualified; and

5.11.2.2 Appointed to their position within the dialysis center by the governing body.

5.11.3 Medical staff privileges must be granted by the governing body, in writing.

5.11.4 Medical staff privileges must be reappraised by the dialysis center at least every 24 months.

5.11.4.1 Reappraisals must include assessment of current competence by the dialysis center medical director.

5.11.5 The medical staff shall adopt, implement and enforce written bylaws to carry out its responsibilities. The bylaws shall:

5.11.5.1 Be approved by the governing body;

5.11.5.2 Include a statement of the duties and privileges of each category of medical staff;

5.11.5.3 Describe the organization of the medical staff; and

5.11.5.4 Include criteria for privileges to be granted and a procedure for applying the criteria to individuals requesting privileges.

5.12 Nursing services

5.12.1 There shall be an organized nursing services which must be under the direction of the nurse manager.

5.12.2 There must be sufficient nursing staff with the appropriate qualifications to assure the nursing needs of all dialysis patients are met.

5.12.3 Nursing services must be provided in accordance with recognized standards of practice.

5.12.4 Charge nurse

5.12.4.1 Each charge nurse must:

5.12.4.1.1 Be a registered nurse; and

5.12.4.1.2 Have at least twelve (12) months full-time nursing experience; and

5.12.4.1.3 Have at least six (6) months full-time experience, within the last twenty-four (24) months, providing nursing care to patients on maintenance dialysis.

5.12.4.2 There must be at least one (1) charge nurse present and designated at all times during the operating hours of the dialysis center.

5.12.4.3 The charge nurse responsibilities include, but are not limited to:

5.12.4.3.1 Making daily patient care assignments based on individual patient needs;

5.12.4.3.2 Providing immediate supervision of direct patient care;

5.12.4.3.3 Patient assessment when indicated; and

5.12.4.3.4 Communicating with other members of the healthcare team.

5.12.5 Staff nurse

5.12.5.1 There must be a registered nurse present and immediately available in the facility at all times in-center dialysis patients are being treated.

5.12.6 Self-care and home dialysis training and support nurse

5.12.6.1 Each nurse responsible for self-care and/or home training and support must:

5.12.6.1.1 Be a registered nurse; and

5.12.6.1.2 Have at least twelve (12) months full-time nursing experience; and

5.12.6.1.3 Have at least three (3) months full-time experience, within the last twenty-four (24) months, in each specific modality for which the nurse will provide training.

5.13 Dietitian

5.13.1 The dialysis center must have a dietitian:

5.13.1.1 Registered with the Commission on Dietetic Registration; and

5.13.1.2 With a minimum of one (1) year professional work experience in clinical nutrition as a registered dietitian.

5.13.2 One full-time equivalent of dietitian time shall be available for up to 100 patients, with the maximum patient load per full-time equivalent of dietitian time being 125 patients for all modalities.

5.14 Social Worker

5.14.1 The dialysis center must have a social worker with a master’s degree in social work with a specialization in clinical practice from a school of social work accredited by the Council on Social Work Education.

5.14.2 Each facility shall employ or contract with a social worker(s) to meet the psychosocial needs of the patients.

5.14.2.1 One (1) full-time equivalent qualified social worker time shall be available for up to 100 patients.

5.14.2.2 If the patient load exceeds 100 patients, personnel shall be assigned to assist a social worker(s) with ancillary tasks (e.g., assistance with financial services, transportation, administrative, clerical, etc.). The maximum patient load, including all modalities, per full-time equivalent qualified social worker, with assigned personnel assistance, is 125 patients.

5.15 Patient Care Technicians

5.15.1 Patient care technicians must:

5.15.1.1 Have a high school diploma or the equivalent;

5.15.1.2 Complete a training program which includes the following subjects:

5.15.1.2.1 The principles of dialysis;

5.15.1.2.2 Care of patients with end stage renal disease;

5.15.1.2.3 Communication and interpersonal skills with end stage renal disease, including:

5.15.1.2.3.1 Patient sensitivity training; and

5.15.1.2.3.2 Care of difficult patients.

5.15.1.2.4 Dialysis procedures and documentation, including:

5.15.1.2.4.1 Initiation of dialysis;

5.15.1.2.4.2 Proper cannulation techniques;

5.15.1.2.4.3 Monitoring during the dialysis treatment;

5.15.1.2.4.4 Termination of dialysis.

5.15.1.2.5 Possible complications of dialysis;

5.15.1.2.6 Water treatment and dialysate preparation;

5.15.1.2.7 Infection control and prevention; and

5.15.1.2.8 Safety.

5.15.1.3 Demonstrate competency in the knowledge and skills of each component of the training program before independently providing patient care; and

5.15.1.3.1 Until the patient care technician has demonstrated competency in each component of the training program, he/she may only provide patient care as part of the training program under the direct supervision of the assigned preceptor.

5.15.1.4 Be certified by a state or national commercially available certification program within 18 months of the hire.

5.16 Water Treatment System Technicians

5.16.1 Prior to performing water treatment task independently, the staff member must complete a training program approved by the medical director and governing body.

5.17 Personnel records

5.17.1 Records of each dialysis center employee/contractor shall be available upon request by authorized representatives of the Department.

5.17.2 The dialysis center shall maintain current individual personnel records for each employee/contractor on-site which shall at a minimum include:

5.17.2.1 Written verification of compliance with pre-employment requirements;

5.17.2.2 Documentation of clinical competence;

5.17.2.3 Evidence of current professional licensure, registration or certification as appropriate;

5.17.2.4 Educational preparation and work history;

5.17.2.5 Written performance evaluations conducted, at least, annually; and

5.17.2.6 A written and signed job description.

5.18 Staff development

5.18.1 All employees/contractors, including medical staff, are required to complete an orientation program.

5.18.2 An orientation/training program should be based on an instruction plan that includes learning objectives, clinical content and minimum acceptable performance standards, and shall include but not be limited to:

5.18.2.1 Organizational structure of the dialysis center;

5.18.2.2 Patient care policies and procedures;

5.18.2.3 Infection control;

5.18.2.4 Philosophy of patient care;

5.18.2.5 Patient rights;

5.18.2.6 Personnel and administrative policies;

5.18.2.7 Job description;

5.18.2.8 Emergency preparedness; and

5.18.2.9 Applicable state regulations governing the delivery of services.

5.18.3 Documentation of orientation must include the date and hours, content, and name and title of the person providing the orientation.

5.18.4 It is the responsibility of the dialysis center to ensure that employees/contractors are proficient to carry out the assigned care in a safe, effective and efficient manner.

5.18.5 Nothing in these regulations is intended to restrict the practice of licensed independent practitioners practicing in accordance with Delaware law.

5.18.6 All newly hired employees and contractors must have a written validation of competency upon orientation, prior to providing care to patients, and annually thereafter.

5.18.7 Attendance records must be kept for all orientation and continuing education programs.

**History**
- *25 DE Reg. 769 (02/01/22)*
- *22 DE Reg. 853 (04/01/19)*
- *25 DE Reg. 769 (02/01/22)*

##### **16 Del. Admin. Code § 3330-6.0** Infection Prevention and Control {#sec-3330-6.0 omnilex-key=us-de-regs-official--title-16--3330-6.0}

6.1 The dialysis center shall establish and implement an infection prevention and control program which shall be based upon nationally recognized infection prevention/control guidelines/standards (such as those developed by the Centers for Disease Control and Prevention).

6.1.1 The infection prevention and control program must include all services and each particular area of the dialysis center.

6.2 The dialysis center must designate in writing, a qualified licensed healthcare professional who will lead the facility’s infection prevention and control program. The dialysis center must determine that the individual has had training in the principles and methods of infection prevention and control.

6.2.1 The individual designated to lead the dialysis center’s infection prevention and control program must develop and implement a comprehensive plan that includes actions to prevent, identify and manage infections and communicable diseases. The plan of action must include mechanisms that result in immediate action to take preventive or corrective measures that improve the dialysis center’s infection control outcomes.

6.3 All dialysis center staff shall receive orientation at the time of employment and annual in-service education regarding the infection prevention and control program.

6.4 Specific Requirements for COVID-19

6.4.1 Before their start date, all new staff, vendors and volunteers must be tested for COVID-19 in accordance with Division of Public Health guidance.

6.4.2 All staff, vendors and volunteers must be tested for COVID-19 in a manner consistent with Division of Public Health guidance.

6.4.3 The dialysis center must follow recommendations of the Centers for Disease Control and Prevention and the Division of Public Health regarding the provision of care or services to patients by staff, vendor or volunteer found to be positive for COVID-19 in an infectious stage.

6.5 The dialysis center shall amend their policies and procedures to include:

6.5.1 Work exclusion and return to work protocols for staff tested positive for COVID-19;

6.5.2 Staff refusals to participate in COVID-19 testing;

6.5.3 Staff refusals to authorize release of testing results or vaccination status to the dialysis center;

6.5.4 Procedures to obtain staff authorizations for release of laboratory test results to the dialysis center to inform infection control and prevention strategies; and

6.5.5 Plans to address staffing shortages and the dialysis center demands should a COVID-19 outbreak occur.

**History**
- *25 DE Reg. 769 (02/01/22)*
- *22 DE Reg. 853 (04/01/19)*
- *25 DE Reg. 769 (02/01/22)*

##### **16 Del. Admin. Code § 3330-7.0** Pharmaceutical Services {#sec-3330-7.0 omnilex-key=us-de-regs-official--title-16--3330-7.0}

7.1 Drugs shall be properly secured and accessible only to authorized personnel.

7.2 Drugs must be prepared and administered according to acceptable standards of practice.

7.3 The dialysis center must designate a specific licensed healthcare professional to provide direction to the dialysis center’s pharmaceutical service.

7.4 Orders given verbally for drugs and biologicals must be followed by a written order and signed by the prescribing physician.

7.5 The dialysis center must maintain compliance with all federal and state laws, regulations and guidelines governing pharmaceutical services.

**History**
- *25 DE Reg. 769 (02/01/22)*
- *22 DE Reg. 853 (04/01/19)*
- *25 DE Reg. 769 (02/01/22)*

##### **16 Del. Admin. Code § 3330-8.0** Reprocessing/Reuse of Hemodialyzers and Bloodlines {#sec-3330-8.0 omnilex-key=us-de-regs-official--title-16--3330-8.0}

The reprocessing and reuse of hemodialyzers, bloodlines and transducer filters is prohibited.

**History**
- *25 DE Reg. 769 (02/01/22)*
- *22 DE Reg. 853 (04/01/19)*
- *25 DE Reg. 769 (02/01/22)*

##### **16 Del. Admin. Code § 3330-9.0** Physical Environment {#sec-3330-9.0 omnilex-key=us-de-regs-official--title-16--3330-9.0}

9.1 The dialysis center must be designed, constructed, equipped and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment.

9.1.1 The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, staff and the public.

9.1.2 The dialysis center must implement and maintain a program to ensure that all equipment used at the dialysis center and by home dialysis patients is maintained and operated in accordance with the manufacturer’s recommendations.

9.1.2.1 The use of “dummy” drip chambers is acceptable only for machine maintenance purposes and shall not be present in the patient treatment areas.

9.1.2.2 The dialysis center shall have a plan of operation and routine maintenance that, at a minimum, includes:

9.1.2.2.1 Hemodialysis delivery system;

9.1.2.2.2 Water treatment system;

9.1.2.2.3 Ancillary equipment;

9.1.2.2.4 Emergency equipment; and

9.1.2.2.5 Furniture.

9.1.3 The area for treating each patient must be sufficient to provide needed care and services, prevent contamination, and to accommodate medical emergency equipment and staff.

9.1.4 The dialysis center must make accommodations to provide for patient privacy any time body exposure is required during treatment or examination.

9.1.5 Each patient, including the face, vascular access site and bloodline connections, must be in view of staff at all times during hemodialysis treatment.

9.1.5.1 Video surveillance does not meet this requirement.

9.1.6 Emergency equipment, including but not limited to, oxygen, airways, suction, defibrillator, artificial resuscitator, and emergency drugs, must be on the premises at all times and immediately available for use.

9.2 Fire Safety

9.2.1 The dialysis center shall comply with the rules and regulations of the State Fire Prevention Commission.

9.2.2 The dialysis center must be inspected annually by the fire marshal having jurisdiction, and all applications for license (new and renewal) must include documentation, dated within the past 12 months, indicating compliance to all applicable fire code regulations.

9.2.2.1 Failure to provide documentation from the fire marshal having jurisdiction, dated within the past 12 months, indicating compliance with all applicable fire code regulations shall be grounds for licensure discipline.

9.2.3 An evacuation floor plan shall be prominently and conspicuously posted for display throughout the facility in areas that are readily visible to patients, staff, and visitors.

9.2.4 The dialysis center shall conduct one (1) fire drill per shift per quarter.

9.2.4.1 Fire drills shall include the transmission of the fire alarm signal and simulation of the emergency fire condition, simulation of evacuation of patients and other occupants, and use of fire-fighting equipment.

9.2.4.2 Written reports shall be maintained to include evidence of patient and staff participation.

9.3 Construction

9.3.1 The provisions of the Facility Guidelines Institute’s Guidelines for Design and Construction of Health Care Facilities, 2018 edition, are hereby adopted as the regulatory requirements for dialysis centers in Delaware and are hereby referred to, and made part of this Regulation, as if fully set out herein.

9.3.1.1 When a dialysis center is classified under this law or regulation and plans to construct, extensively remodel or convert any buildings, two (2) copies of the properly prepared plans and specifications for the entire dialysis center shall be submitted to the Department.

9.3.1.2 An approval, in writing shall be obtained from the Department before construction/renovation/remodeling work is begun.

9.3.1.3 Upon completion of construction/renovation/remodeling, in accordance with the plans and specifications, the Department will inspect and approve the site prior to occupancy/use by the dialysis center.

9.3.1.4 All facilities shall either be at grade level or shall be equipped with ramps and elevators to allow easy access for persons with disabilities.

9.3.1.5 The dialysis center shall comply with all local and state building codes and ordinances as pertains to this occupancy.

9.3.1.6 Waiver of a standard requires Department approval. Waiver requests must be made in writing, include the full justification behind the request and address issues of safety and infection control. Waivers are an exception to established standards and will only be approved for compelling reasons.

9.3.1.7 Dialysis centers existing prior to the implementation of this regulation shall continue, at a minimum, to meet the building requirements specified in the original approval.

**History**
- *25 DE Reg. 769 (02/01/22)*
- *22 DE Reg. 853 (04/01/19)*
- *25 DE Reg. 769 (02/01/22)*

##### **16 Del. Admin. Code § 3330-10.0** Patient Rights {#sec-3330-10.0 omnilex-key=us-de-regs-official--title-16--3330-10.0}

10.1 The dialysis center must inform the patient, or patient’s representative of the patient’s rights and responsibilities:

10.1.1 In a language and manner that the patient or patient representative understands; and

10.1.2 Within the first six (6) hemodialysis treatments after admission.

10.2 Documentation must confirm that the dialysis center informed the patient, or patient’s representative of the patient’s rights and responsibilities.

10.3 The patient’s rights shall be posted in a conspicuous place in the facility’s waiting room and must include the address and telephone number of the Department and Quality Insights Renal Network 4 to which patients may report complaints.

10.4 Written notice to the patient shall include the patient’s right to:

10.4.1 Be treated with respect, dignity, and recognition of his/her individuality and personal needs;

10.4.2 Receive care in a safe and sanitary environment;

10.4.3 Receive all information in a language and manner that he/she can understand;

10.4.4 Privacy and confidentiality in all aspects of treatment and personal medical records;

10.4.5 Be free from abuse, neglect, and exploitation;

10.4.6 Be informed about and participate, if desired, in all aspects of his/her care, including the right to refuse or discontinue treatment, and the consequences of such decisions;

10.4.7 Be informed about his/her right to execute an advance directive and the dialysis center’s policy regarding advance directives;

10.4.8 Be informed about all dialysis treatment modalities and options (i.e. alternative scheduling options) including those dialysis modalities and options not offered by the dialysis center;

10.4.9 Be informed of the dialysis center’s policies regarding patient care, including but not limited to the isolation of patients;

10.4.10 Be informed by the physician or non-physician practitioner treating the patient for ESRD of his/her own medical status, unless the medical record contains a documented contraindication;

10.4.11 Be informed of the services available in the facility and charges for such services;

10.4.12 Be informed of the dialysis center’s internal grievance process and external grievance mechanisms;

10.4.13 File grievances regarding treatment or care that is (or fails to be) furnished; and

10.4.14 Be informed of the dialysis centers policies for transfer, routine or involuntary discharge, and discontinuation of services.

**History**
- *25 DE Reg. 769 (02/01/22)*
- *22 DE Reg. 853 (04/01/19)*
- *25 DE Reg. 769 (02/01/22)*

##### **16 Del. Admin. Code § 3330-11.0** Patient Assessment {#sec-3330-11.0 omnilex-key=us-de-regs-official--title-16--3330-11.0}

11.1 The dialysis center interdisciplinary team:

11.1.1 Must consist of at a minimum:

11.1.1.1 The patient or patient representative;

11.1.1.2 A registered nurse;

11.1.1.3 A social worker;

11.1.1.4 A dietitian; and

11.1.1.5 A physician treating the patient for ESRD.

11.1.2 Is responsible to conduct an individualized and comprehensive assessment of each patient, which is used to develop the patient’s treatment plan and expectations of care.

11.2 Each comprehensive assessment must include, but is not limited to evaluation and documentation of the following:

11.2.1 The current health status and medical conditions;

11.2.2 The appropriateness of the dialysis prescription;

11.2.3 Blood pressure and fluid management needs, including:

11.2.3.1 Pre/intra/post and interdialytic blood pressures;

11.2.3.2 Interdialytic weight gains;

11.2.3.3 Target weights; and

11.2.3.4 Intradialytic symptoms.

11.2.4 Laboratory profile;

11.2.5 Immunization history, including but not limited to:

11.2.5.1 Pneumococcal immunization;

11.2.5.2 Hepatitis immunization;

11.2.5.3 Influenza immunization; and

11.2.5.4 Tuberculosis screening.

11.2.6 Medication history, including allergies and all medications (prescription and over the counter) and supplements;

11.2.7 Factors associated with anemia;

11.2.8 Factors associated with renal bone disease;

11.2.9 Nutritional status by the dietitian;

11.2.10 Psychosocial needs by the social worker;

11.2.11 Dialysis access type and maintenance;

11.2.12 The patient’s abilities, interests, preferences, and goals, including the desired level of participation in the dialysis care process;

11.2.13 The preferred modality (hemodialysis or peritoneal dialysis) and setting (in-center or home);

11.2.14 The patient’s expectations for care outcomes;

11.2.15 The suitability, or reason for non-referral, of a transplant referral;

11.2.16 Family and/or other support systems;

11.2.17 Current physical activity level to determine if the patient is a candidate for referral to vocational and/or physical rehabilitation services;

11.3 Frequency of comprehensive assessments for patients new to dialysis

11.3.1 Patients changing dialysis modalities or returning to dialysis from a failed transplant are considered new patients.

11.3.2 An initial comprehensive assessment must be completed on each new patient within the latter of 30 calendar days, or 13 hemodialysis treatments, of admission.

11.3.3 A follow up comprehensive assessment must be completed three (3) months after the completion of the initial comprehensive assessment.

11.4 Comprehensive reassessments must be completed as follows:

11.4.1 Annually for stable patients; and

11.4.2 At least monthly for patients with the following:

11.4.2.1 More than three (3) hospitalizations in one (1) month;

11.4.2.2 Marked deteriorations;

11.4.2.3 Any event that interferes with the patient’s ability to follow the treatment plan; or

11.4.2.4 Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis.

11.5 Adequacy of the dialysis prescription must be assessed as follows:

11.5.1 Hemodialysis patients

11.5.1.1 At least monthly calculations of the Kt/V or an equivalent measurement.

11.5.2 Peritoneal dialysis patients

11.5.2.1 At least every four (4) months by calculations of delivered weekly Kt/V or an equivalent measurement.

**History**
- *25 DE Reg. 769 (02/01/22)*
- *22 DE Reg. 853 (04/01/19)*
- *25 DE Reg. 769 (02/01/22)*

##### **16 Del. Admin. Code § 3330-12.0** Patient Plan of Care {#sec-3330-12.0 omnilex-key=us-de-regs-official--title-16--3330-12.0}

12.1 The interdisciplinary team must develop and implement a written, comprehensive, individualized plan of care for each patient based on the comprehensive assessment which:

12.1.1 Specifies the services necessary to address the patient’s needs; and

12.1.2 Includes measureable and expected outcomes and estimated timetables to achieve these outcomes.

12.1.2.1 Outcomes must be consistent with current evidence-based professionally-accepted clinical standards of practice.

12.2 The plan of care must address:

12.2.1 Dose of dialysis;

12.2.2 Dialysis adequacy;

12.2.3 Nutritional status;

12.2.4 Mineral metabolism;

12.2.5 Anemia;

12.2.6 Vascular access;

12.2.7 Psychosocial status;

12.2.8 Modality;

12.2.9 Transplantation status;

12.2.10 Rehabilitation status; and

12.2.11 Patient education and training.

12.3 The plan of care shall include evidence of coordination with other providers (i.e. hospitals, long term care facilities, home and community support services, transportation services, etc.) as needed to assure the provision of safe care.

12.4 Implementation of the plan of care

12.4.1 The plan of care must be signed and dated by all members of the interdisciplinary team.

12.4.1.1 If the patient chooses not to sign the plan of care, this choice must be documented along with the rationale the signature was not provided.

12.4.2 The initial plan of care must be implemented within the latter of 30 calendar days after admission to the dialysis center or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session.

12.4.3 Implementation of monthly or annual updates of the plan of care must be performed within 15 days of the completion of the comprehensive assessment as required by subsection 12.4.

12.4.4 If the expected outcome is not achieved, the interdisciplinary team must:

12.4.4.1 Revise the plan of care to reflect the patient’s current condition;

12.4.4.2 Document the reason(s) why the patient was unable to achieve the goal; and

12.4.4.3 Implement the revisions to the plan of care.

12.5 The dialysis center must ensure that all dialysis patients are seen and evaluated by a physician or non-physician provider providing ESRD care at least monthly and at least quarterly while the patient is receiving in-center hemodialysis, as evidenced by documentation in the medical record.

**History**
- *25 DE Reg. 769 (02/01/22)*
- *22 DE Reg. 853 (04/01/19)*
- *25 DE Reg. 769 (02/01/22)*

##### **16 Del. Admin. Code § 3330-13.0** Home Dialysis Service {#sec-3330-13.0 omnilex-key=us-de-regs-official--title-16--3330-13.0}

13.1 A dialysis center that provides home dialysis training and support must be approved to provide home dialysis services, and ensure through its interdisciplinary team that home dialysis services are at least equivalent to those services provided to in-center patients.

13.2 The interdisciplinary team must oversee the training of the home dialysis patient, the designated caregiver(s), or self-dialysis patient before the initiation of home dialysis or self-dialysis and when the home dialysis caregiver(s) or modality changes.

13.3 The home dialysis training program must:

13.3.1 Be provided by a dialysis center that is licensed to provide home dialysis services;

13.3.2 Be approved by the medical director;

13.3.3 Be conducted by a registered nurse who meets the requirements set forth in subsection 5.11.6.1;

13.3.4 Be conducted for each home dialysis patient and at a minimum address the specific needs of the patient in the following areas:

13.3.4.1 The nature and management of ESRD;

13.3.4.2 The full range of techniques associated with the treatment modality selected, including:

13.3.4.2.1 Effective use of dialysis supplies and equipment in achieving and delivering the physician’s prescription; and

13.3.4.2.2 Safe storage and administration of erythropoiesis-stimulating agent(s) (if applicable) to achieve and maintain the target level hemoglobin and/or hematocrit as written in the patient’s plan of care.

13.3.4.3 How to detect, report, and manage potential dialysis complications, including water treatment problems;

13.3.4.4 Availability of support resources and how to access and use those resources;

13.3.4.5 How to self-monitor health status and document and report health status information;

13.3.4.6 How to handle medical and non-medical emergencies;

13.3.4.7 Infection control and prevention precautions; and

13.3.4.8 Proper waste storage and disposal.

13.4 Home dialysis monitoring

13.4.1 The dialysis center must:

13.4.1.1 Document in the medical record that the patient, patient’s caregiver(s) or both received and demonstrated adequate comprehension of the training;

13.4.1.2 Retrieve and review complete self-monitoring data from home dialysis patients, or their designated caregiver(s) at least every two (2) months;

13.4.1.3 Maintain documentation and self-monitoring data in the patient’s medical record; and

13.4.1.4 If the patient or designated caregiver has not provided appropriate self-monitoring data at least every two (2) months, dialysis center staff must make and document all reasonable efforts to obtain these records (if applicable).

13.5 A dialysis center that provides home dialysis training and support must furnish home dialysis support services regardless of whether dialysis supplies are provided by the dialysis center or a durable medical equipment company.

13.5.1 Support services must include, but are not limited to:

13.5.1.1 Periodic monitoring of the patient’s home adaptation, including visits to the patient’s home in accordance with the plan of care;

13.5.1.1.1 A home visit must be conducted at the initiation of home dialysis, annually and whenever a health or treatment problem is identified that could be related to the home dialysis.

13.5.1.2 Coordination of the home dialysis patient’s care by a designated member of the interdisciplinary team;

13.5.1.3 Patient consultation with members of the interdisciplinary team as needed;

13.5.1.4 Monitoring of the home hemodialysis patient’s water quality and dialysate, including:

13.5.1.4.1 Conducting an onsite evaluation; and

13.5.1.4.2 Testing the water and dialysate:

13.5.1.4.2.1 Prior to the initiation of home dialysis;

13.5.1.4.2.2 In accordance with the manufacturer’s instructions; and

13.5.1.4.3 Correcting any water and/or dialysate quality issues, and if necessary, arrange for backup dialysis until the issues are resolved if:

13.5.1.4.3.1 Analysis of water and/or dialysate indicates contamination; or

13.5.1.4.3.2 The home dialysis patient demonstrates clinical symptoms associated with contaminated water and dialysate.

13.5.1.5 Purchasing, leasing, renting, delivering, installing, repairing and maintaining medically necessary home dialysis supplies and equipment;

13.5.1.6 Identifying a plan and arranging for emergency back-up dialysis when necessary.

13.6 Coordination of Services when providing home dialysis in a long term care facility:

13.6.1 Prior to providing home dialysis in a long term care facility, the dialysis center and long term care facility must have a written coordination agreement that outlines clear lines of responsibility and accountability.

13.6.1.1 There must be a written coordination agreement with each long term care facility in which home dialysis patients reside.

13.6.1.2 Each written coordination agreement shall be reviewed and updated at least annually.

13.6.2 The dialysis center is primarily responsible for the quality and safety of the dialysis treatments, including:

13.6.2.1 Training of the patient and each long term care facility staff member that provides home dialysis services;

13.6.2.2 Monitoring of the patient and the home dialysis environment;

13.6.2.3 Availability of social work and nutritional consultation;

13.6.2.4 Assuring continuity of care;

13.6.2.5 Installing and maintaining home dialysis equipment;

13.6.2.5.1 There must be one machine used exclusively for each individual patient’s home dialysis treatments. The same dialysis machine must not be used for multiple home dialysis patients.

13.6.2.6 Testing and treating of water; and

13.6.2.7 Ordering dialysis-related supplies.

13.6.3 The dialysis center must maintain documentation that each long term care facility staff member has received, and demonstrated adequate comprehension, of the training specific to each patient that he/she will be providing home dialysis services.

**History**
- *25 DE Reg. 769 (02/01/22)*
- *22 DE Reg. 853 (04/01/19)*
- *25 DE Reg. 769 (02/01/22)*

##### **16 Del. Admin. Code § 3330-14.0** Medical Records {#sec-3330-14.0 omnilex-key=us-de-regs-official--title-16--3330-14.0}

14.1 The dialysis center shall develop and maintain a system for the collection, processing, maintenance, storage, retrieval, authentication and distribution of patient medical records. Records may exist in hard copy, electronic format, or a combination of the two media.

14.1.1 There shall be an identified locked area for medical record storage at the dialysis center.

14.2 A complete, accurate, legible and accessible medical record must be maintained on every individual receiving care in the dialysis center.

14.2.1 Each medical record shall include, but is not limited to the following:

14.2.1.1 Identifying information;

14.2.1.2 Consents;

14.2.1.3 Medical and surgical history;

14.2.1.4 Record of the creation and revision of the dialysis access;

14.2.1.5 A comprehensive history and physical examination completed within thirty (30) days of the patient’s admission to the dialysis center, and no less than annually thereafter;

14.2.1.5.1 For a patient new to dialysis, the physician is responsible to complete the comprehensive history and physical examination.

14.2.1.5.1.1 Prior to the first treatment in the dialysis center, the physician shall inform the registered nurse functioning in the charge role of at least the patient’s diagnoses, medications, hepatitis status, allergies, and dialysis treatment prescription.

14.2.1.5.2 For established dialysis patients, the physician or non-physician practitioners may complete the comprehensive history and physical examination.

14.2.1.6 Physician orders, including dialysis treatment orders;

14.2.1.7 Progress notes regarding the condition and care of the patient;

14.2.1.8 Medication administration records (this can be documented on the treatment sheets);

14.2.1.9 A list of medications, including those the patient takes at home, and allergies;

14.2.1.10 Transfusion records;

14.2.1.11 Laboratory and diagnostic study reports;

14.2.1.12 Evidence of patient education;

14.2.1.13 Dialysis treatment records;

14.2.1.14 Patient assessments;

14.2.1.15 Patient plans of care;

14.2.1.16 Documentation regarding the patient’s advance directive status;

14.2.1.17 Hospitalization reports; and

14.2.1.18 A discharge summary (if applicable).

14.2.2 Home dialysis patient medical records must include:

14.2.2.1 Treatment records maintained by the patient, retrieved and reviewed for adherence to the treatment prescription every two (2) months;

14.2.2.1.1 If the home dialysis patient is a resident of a long term care facility, the treatment records must indicate the name of the long term care facility staff member that provided home dialysis services.

14.2.2.2 Documentation of home dialysis training and adequate comprehension of the training;

14.2.2.3 The provision of home dialysis support services (i.e. dialysis supplies and durable medical equipment); and

14.2.2.4 Periodic home visits and monitoring of the patient’s home adaption.

14.2.3 All entries in the medical record shall be dated, timed and authenticated by the responsible person in accordance with the dialysis center's policies and procedures.

14.2.4 Signature stamps may not be used to authenticate medical record entries.

14.3 Medical records shall be protected from loss, tampering, alteration, improper destruction, and unauthorized or inadvertent use.

14.3.1 The dialysis center must:

14.3.1.1 Maintain compliance with all federal and state laws, regulations and guidelines governing patient privacy and medical records;

14.3.1.2 Ensure that each medical record is treated with confidentiality and is maintained according to professional standards of practice; and

14.3.1.3 Obtain written permission from the patient or the patient’s legal representative before releasing information that is not authorized by law.

14.3.2 Medical records shall be retained in a retrievable form until destroyed.

14.3.2.1 Medical records of adults (18 years of age and older) shall be retained for a minimum of six (6) years after the patient’s discharge, transfer or death before being destroyed.

14.3.2.2 Records of minors (less than 18 years of age) shall be retained for a minimum of six (6) years after the patient reached 18 years of age.

14.3.2.3 The dialysis center shall not destroy medical records that relate to any matter that is involved in litigation if the facility knows the litigation has not been fully resolved.

14.3.2.4 All records must be disposed of by shredding, burning or other similar protective measure in order to preserve the patient’s right to confidentiality.

14.3.2.5 The dialysis center must establish procedures for the notification to patients regarding the pending destruction of the medical records.

14.3.2.6 Documentation of medical record destruction must be maintained by the dialysis center.

14.4 When a dialysis patient is transferred to another dialysis center, the dialysis center releasing the patient must send all medical record information to the receiving facility within one (1) working day of the transfer.

14.5 Prior to providing dialysis treatment to a transient patient, a dialysis center shall obtain:

14.5.1 Orders for dialysis treatment;

14.5.2 A list of medications and allergies;

14.5.3 Reports of laboratory work, including screening for hepatitis B status, that was performed no more than one (1) month prior to treatment at the dialysis center;

14.5.4 The most current plan of care; and

14.5.5 The most current treatment records from the referring facility.

14.6 If the dialysis center plans to close, the facility shall notify the Department in writing at the time of closure of the disposition of the medical records, including where the medical records will be stored, and the name, address, and phone number of the custodian of the records.

14.7 All patient records shall be available for review by authorized representatives of the Department and to legally authorized persons.

14.8 Computerized patient records must be printed by the dialysis center as requested by authorized representatives of the Department.

**History**
- *25 DE Reg. 769 (02/01/22)*
- *22 DE Reg. 853 (04/01/19)*
- *25 DE Reg. 769 (02/01/22)*

##### **16 Del. Admin. Code § 3330-15.0** Laboratory Services {#sec-3330-15.0 omnilex-key=us-de-regs-official--title-16--3330-15.0}

15.1 The dialysis center must provide, or make available, laboratory services (except tissue pathology and histocompatibility) to meet the needs of the ESRD patient.

15.2 Any laboratory services must be furnished by, or obtained from, a facility that meets the requirements set forth in 42 CFR Part 493.

15.3 Contracts for laboratory services must be in writing and shall specify:

15.3.1 The types of laboratory test to be performed;

15.3.2 Methods for collection and handling of specimens; and

15.3.3 How results are delivered, including a timeline for reporting “panic” values to a responsible person.

**History**
- *25 DE Reg. 769 (02/01/22)*
- *22 DE Reg. 853 (04/01/19)*
- *25 DE Reg. 769 (02/01/22)*

##### **16 Del. Admin. Code § 3330-16.0** Quality Assessment and Performance Improvement {#sec-3330-16.0 omnilex-key=us-de-regs-official--title-16--3330-16.0}

16.1 The dialysis center must develop, implement, maintain, and evaluate an effective, ongoing facility-wide, data driven, interdisciplinary QAPI program.

16.2 The QAPI program shall reflect the complexity of the dialysis center’s organization and services, including those services furnished under contract or arrangement, and must focus on indicators related to improved health outcomes and the prevention and reduction of medical errors.

16.2.1 There must be an operationalized, written plan describing the QAPI program scope, objectives, organizations, responsibilities of all participants, and procedures for overseeing the effectiveness of monitoring, assessing and problem solving activities.

16.3 The QAPI program shall include:

16.3.1 An ongoing review of key elements of care using comparative and trend data to include aggregate patient data;

16.3.2 Identification of areas where performance measures or outcomes indicate an opportunity for improvement;

16.3.3 Appointment of an interdisciplinary team to:

16.3.3.1 Identify, measure, analyze and track indicators for variation from desired outcomes;

16.3.3.2 Create and implement improvement plan(s);

16.3.3.3 Evaluate the implementation of the improvement plan(s); and

16.3.3.4 Continuously monitor performance, take actions that result in performance improvements and track performance to ensure that improvements are sustained over time.

16.3.4 Establishment and monitoring of quality indicators related to improved health outcomes and the identification and reduction of medical errors. For each quality assessment indicator, the facility shall establish and monitor a level of performance consistent with current professional knowledge. These performance components shall influence or relate to the desired outcomes themselves. At a minimum, the following indicators shall be measured, analyzed, and tracked on a monthly basis:

16.3.4.1 Water and dialysate quality;

16.3.4.2 Dialysis equipment repair and maintenance;

16.3.4.3 Dialysis adequacy;

16.3.4.4 Nutritional status;

16.3.4.5 Mineral metabolism and renal disease bone management;

16.3.4.6 Anemia management;

16.3.4.7 Fluid and blood pressure management;

16.3.4.8 Vascular and/or peritoneal dialysis access;

16.3.4.9 Patient modality choice and transplant referral;

16.3.4.10 Personnel qualifications and issues;

16.3.4.11 Infection prevention and control;

16.3.4.12 Medical errors and medical injuries;

16.3.4.13 Adverse occurrences;

16.3.4.14 Patient satisfaction and grievances;

16.3.4.15 Physical plant safety audits;

16.3.4.16 ESRD Network 4 relationship and communications; and

16.3.4.17 Morbidity and mortality.

16.4 The dialysis center must set priorities for performance improvement, considering prevalence and severity of identified problems and giving priority to improvement activities that affect clinical outcomes or patient safety.

16.5 The dialysis center shall immediately correct any identified problems that threaten the health and safety of patients.

16.6 The Department may review the dialysis center’s QAPI activities to determine compliance with these requirements.

**History**
- *25 DE Reg. 769 (02/01/22)*
- *22 DE Reg. 853 (04/01/19)*
- *25 DE Reg. 769 (02/01/22)*

##### **16 Del. Admin. Code § 3330-17.0** General Requirements {#sec-3330-17.0 omnilex-key=us-de-regs-official--title-16--3330-17.0}

17.1 The provisions of 42 CFR Ch. IV, Part 494, Subparts A, B, C and D are hereby adopted as the regulatory requirements for dialysis centers in Delaware and are hereby referred to, and made part of this Regulation, as if fully set out herein.

17.2 The provisions of the 2012 National Fire Protection Association’s Life Safety Code, as adopted and modified by the State Fire Prevention Regulations, are hereby adopted as the regulatory requirements for dialysis centers in Delaware and are hereby referred to, and made part of this Regulation, as if fully set out herein.

17.3 The provisions of the Centers for Disease Control and Prevention Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, available at: https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5417a1.htm are hereby adopted as the regulatory requirements for dialysis centers in Delaware and are hereby referred to, and made part of this Regulation, as if fully set out herein.

17.4 The provisions of the State of Delaware, Department of Natural Resources and Environmental Control, Regulations Governing Solid Waste, 7 DE Admin. Code 1301 are hereby adopted as the regulatory requirements for dialysis centers in Delaware and are hereby referred to, and made part of this Regulation, as if fully set out herein.

17.5 The provisions of the Centers for Disease Control and Prevention recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients, Morbidity and Mortality Weekly Report, available at: https://www.cdc.gov/mmwr/pdf/rr/rr5005.pdf are hereby adopted as the regulatory requirements for dialysis centers in Delaware and are hereby referred to, and made part of this Regulation, as if fully set out herein.

17.6 No policies shall be adopted by the dialysis center which are in conflict with these regulations.

17.7 The dialysis center may contract for services to be provided to its patients. Individuals providing services under contract must meet the same requirements as those persons employed directly by the dialysis center.

17.8 All records maintained by the dialysis center shall at all times be open to inspection by authorized representatives of the Department.

17.8.1 The dialysis center must permit photocopying of any records or other information by, or on behalf of authorized representatives of the Department, as necessary to determine or verify compliance with these regulations.

17.9 Reports of adverse events shall be kept on file at the dialysis center for a minimum of five (5) years.

17.10 Report of major adverse events

17.10.1 The dialysis center must report all major adverse events involving a patient to the Department within 48 hours in addition to other reporting requirements required by law.

17.10.2 A major adverse event includes but is not limited to:

17.10.2.1 Suspected abuse, neglect, mistreatment, financial exploitation, solicitation or harassment of patients;

17.10.2.2 Death of a patient during a dialysis treatment;

17.10.2.3 A medication error with the potential to result in adverse health outcomes for the patient;

17.10.2.4 Conversion of staff or a patient to hepatitis B surface antigen positive;

17.10.2.5 Involuntary transfer or discharge of a patient; and

17.10.2.6 A fire in the dialysis center.

17.10.3 Major adverse events must be investigated by the dialysis center.

17.10.4 The dialysis center must submit a complete report to the Department within 30 calendar days of the event.

17.11 Each dialysis center shall designate at least one (1) patient representative for the Quality Insights Renal Network 4 Program.

**History**
- *25 DE Reg. 769 (02/01/22)*
- *22 DE Reg. 853 (04/01/19)*
- *25 DE Reg. 769 (02/01/22)*

##### **16 Del. Admin. Code § 3330-18.0** Emergency Preparedness {#sec-3330-18.0 omnilex-key=us-de-regs-official--title-16--3330-18.0}

18.1 The provisions of 42 CFR Ch. IV, Part 494.62 are hereby adopted as the regulatory requirements for dialysis centers in Delaware and are hereby referred to, and made part of this Regulation, as if fully set out herein.

18.2 The dialysis center must be connected to an emergency power source to ensure that all dialysis machines will operate for at least four (4) hours following a power shutdown or outage.

18.2.1 The emergency power source must be in working condition at all times.

18.2.2 The dialysis center must conduct and document at least a monthly test of those emergency power sources.

18.3 In the event of inclement weather, or any other interruption of dialysis center’s normal business hours, the dialysis center must report the status of the facility’s operation by completing and submitting the “Facility Status Reporting Tool” located on the Quality Insights Renal Network 4 website.

**History**
- *25 DE Reg. 769 (02/01/22)*
- *22 DE Reg. 853 (04/01/19)*
- *25 DE Reg. 769 (02/01/22)*

##### **16 Del. Admin. Code § 3330-19.0** Severability {#sec-3330-19.0 omnilex-key=us-de-regs-official--title-16--3330-19.0}

In the event any particular clause or section of these regulations should be declared invalid or unconstitutional by any court of competent jurisdiction, the remaining portions shall remain in full force and effect.

**History**
- *25 DE Reg. 769 (02/01/22)*
- *22 DE Reg. 853 (04/01/19)*
- *25 DE Reg. 769 (02/01/22)*

#### **3335** Office-Based Surgery

##### **16 Del. Admin. Code § 3335-1.0** Purpose {#sec-3335-1.0 omnilex-key=us-de-regs-official--title-16--3335-1.0}

Delaware Department of Health and Social Services adopts these regulations pursuant to the authority vested by 16 Del.C. §122(3)(y and z). These regulations establish standards with respect to the safe and sanitary conditions, and require the accreditation of any facility that performs office-based surgery. These regulations also provide for the investigation of any patient or current facility employee complaints involving the unsafe and/or unsanitary conditions in such facilities.

**History**
- *23 DE Reg. 125 (08/01/19)*
- *18 DE Reg. 862 (05/01/15)*
- *23 DE Reg. 125 (08/01/19)*
- *23 DE Reg. 125 (08/01/19)*
- *25 DE Reg. 770 (02/01/22)*
- *23 DE Reg. 125 (08/01/19)*
- *23 DE Reg. 125 (08/01/19)*
- *17 DE Reg. 848 (02/01/14)*
- *18 DE Reg. 862 (05/01/15)*
- *23 DE Reg. 125 (08/01/19)*
- *25 DE Reg. 770 (02/01/22)*

##### **16 Del. Admin. Code § 3335-2.0** Definitions {#sec-3335-2.0 omnilex-key=us-de-regs-official--title-16--3335-2.0}

The following words and terms, when used in this regulation, should have the following meaning unless the context clearly indicates otherwise:

"Accredited Facility" means a facility that is accredited by an accrediting organization approved by the Department. Approval requires an accrediting organization to be independent from the facility.

"Accrediting Organization" means an organization able to measure the quality of facility's services and performance against nationally-recognized and evidenced-based standards that focus on (1) ensuring quality health care and provider competence, (2) reducing risks, (3) monitoring standards of practice (4) promoting continuous quality improvement, and (5) demonstrating accountability. The organization requires facilities to complete self-assessments and expert surveyors to conduct thorough reviews.

"Adverse Event" means the death or serious injury of any patient at a facility; a reasonable determination by the Department that death or serious injury may result from any unsafe or unsanitary condition at a facility; or the initiation of any criminal investigation arising out of or relating to any diagnosis, treatment or other medical care at a facility.

"Anesthesia" means anxiolysis, conscious sedation, deep sedation, major conduction anesthesia, minimal sedation, moderate sedation or general anesthesia and all anesthesia, including local anesthesia, used for surgical abortions. For office-based surgery other than surgical abortions, the following shall be excluded from the definition of anesthesia: (1) local anesthesia, (2) the administration of less than 50% nitrous oxide in oxygen with or without local anesthesia but with no other sedative or analgesic medications by any route, or (3) the administration of a single, oral sedative or analgesic medication in doses appropriate for the unsupervised treatment of insomnia, anxiety, or pain with or without local anesthesia.

"Anxiolysis" means minimal sedation.

"ASA Classification" means the American Society of Anesthesiologists's physical status classification of preoperative patients for anesthetic risk assessment.

"Certified Registered Nurse Anesthetist" means an individual currently licensed as an advanced practice nurse under 24 Del.C. Ch.19.

"Complaint" means a complaint filed by a patient or current facility employee in writing, in such format as the Department requires.

"Conscious Sedation" means moderate sedation.

"Deep Sedation" means a drug-induced depression of consciousness during which: (1) patients cannot be easily aroused but respond purposefully following repeated or painful stimulation, (2) the ability to independently maintain ventilatory function may be impaired, (3) patients may require assistance in maintaining a patent airway, and spontaneous ventilation may be inadequate, and (4) cardiovascular function is usually maintained.

"Dentist" means an individual currently licensed as a dentist under 24 Del.C. Ch. 11.

"Department" means the Delaware Department of Health and Social Services or its designee.

"Facility" means a location at which any office-based surgery is performed, but does not include any hospital, as defined in 16 Del.C. §1001, or any freestanding birthing center, freestanding surgical center or freestanding emergency department as such terms are defined in 16 Del.C. §122(3)p.

"General Anesthesia" means a drug-induced loss of consciousness during which: (1) patients are not arousable, even by painful stimulation, (2) the ability to independently maintain ventilatory function is often impaired, (3) patients often require assistance in maintaining a patent airway, and positive pressure ventilation may be required because of depressed spontaneous ventilation or drug-induced depression of neuromuscular function, and (4) cardiovascular function may be impaired.

"Local Anesthesia" means the injection of the skin or muscle, or application of an anesthetic drug to a specific area of the body, to prevent patients from feeling pain directly where the pain will occur during a medical, surgical or dental procedure. Local anesthesia can be divided into four groups: injectable, topical, dental (non-injectable) and ophthalmic.

"Major Conduction Anesthesia" means the administration of a drug, or a combination of drugs, to interrupt nerve impulses without loss of consciousness, e.g. epidural, caudal, or spinal anesthesia, lumbar or brachial plexus blocks, and intravenous regional anesthesia. However, isolated blockade of small peripheral nerves, such as digital nerves are not included.

"Minimal Sedation" means a drug-induced state during which: (1) patients respond normally to verbal commands, and (2) cognitive and physical coordination may be impaired but airway reflexes and ventilatory and cardiovascular functions are unaffected.

"Moderate Sedation" means a drug-induced depression of consciousness during which: (1) patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation, (2) no interventions are required to maintain a patent airway, (3) spontaneous ventilation is adequate, and (4) cardiovascular function is usually maintained.

“Musculoskeletal Injection” means a trigger point injection, lumbar puncture, or injection that targets a joint, including shoulder, hip, knee, elbow, hand, wrist, foot, ankle, and sacroiliac joint. Musculoskeletal injections do not include any other injection in which the spine is the target of the injection.

“Office-Based Surgery” means any medical procedure, including dental and podiatric procedures, which include any of the following: (1) Surgical abortions, (2) Procedures in which the facility utilizes anesthesia, major conduction anesthesia or sedation, (3) Procedures in which the spine (i.e. epidural, facet joint) is the target of an injection, or (4) Procedures in which the accepted standard of care requires anesthesia, major conduction anesthesia or sedation. Office-based surgery does not include musculoskeletal injections.

"Patient" means a person, person's spouse, parent, legal guardian, or legal custodian of a person under 18 or any legal guardian or legal custodian of a person who is an adult, who has received diagnosis, treatment or other medical care at a facility.

"Physician" means an individual currently licensed as a physician under 24 Del.C. Ch. 17.

"Physician Assistant" means an individual currently licensed as a physician assistant under 24 Del.C. Ch. 17.

"Plan of Correction" means a facility's written response to findings of regulatory non-compliance. Plans must adhere to the format specified by the Department, include acceptable timeframes in which deficiencies will be corrected and must be approved by the Department.

"Podiatrist" means an individual currently licensed as a podiatrist under 24 Del.C. Ch. 5.

"Procedure" means office-based surgery.

"Registered Nurse" means an individual currently licensed as a registered nurse under 24 Del.C. Ch.19.

"Serious Injury" means physical injury that creates a substantial risk of death, or that causes serious disfigurement, prolonged impairment of health or prolonged loss or impairment of the function of any bodily organ or which causes the termination of a pregnancy without the consent of the pregnant female.

"Time-out" means a pause in action conducted in the procedure room immediately before the procedure is to begin. The time-out (1) involves the entire operative team, including the patient, (2) uses active communication, and (3) includes correctly identifying: the patient, the procedure, and the site.

**History**
- *23 DE Reg. 125 (08/01/19)*
- *18 DE Reg. 862 (05/01/15)*
- *23 DE Reg. 125 (08/01/19)*
- *23 DE Reg. 125 (08/01/19)*
- *25 DE Reg. 770 (02/01/22)*
- *23 DE Reg. 125 (08/01/19)*
- *23 DE Reg. 125 (08/01/19)*
- *17 DE Reg. 848 (02/01/14)*
- *18 DE Reg. 862 (05/01/15)*
- *23 DE Reg. 125 (08/01/19)*
- *25 DE Reg. 770 (02/01/22)*

##### **16 Del. Admin. Code § 3335-3.0** Patient Care {#sec-3335-3.0 omnilex-key=us-de-regs-official--title-16--3335-3.0}

3.1 The physician/dentist/podiatrist must determine that the facility is an appropriate forum for the particular procedure(s) to be performed on the particular patient.

3.2 The physician/dentist/podiatrist and/or when involved, the certified registered nurse anesthetist, must determine whether the patient is an appropriate candidate for the anesthesia to be provided in the facility using the ASA classification system.

3.2.1 The physician/dentist/podiatrist or certified registered nurse anesthetist must examine the patient immediately before the procedure to evaluate the risk of anesthesia and of the procedure to be performed.

3.3 The facility must maintain written protocols for the timely and safe transfer of a patient to a hospital for emergency care or hospitalization if necessary.

3.4 At least one attending clinical team member must be certified in Advanced Cardiac Life Support.

3.5 The facility must maintain equipment and supplies, unless precluded or invalidated by the nature of the patient, procedure, or equipment, including but not limited to:

3.5.1 Age-appropriate and size-appropriate monitors, resuscitative equipment, supplies and medication in accordance with the scope of the procedures and the anesthesia services provided, including, but not limited to:

3.5.1.1 Electrocardiographic monitor;

3.5.1.2 Blood pressure monitor;

3.5.1.3 Pulse oximeter;

3.5.1.4 Continuous suction device;

3.5.1.5 Positive pressure ventilation device;

3.5.1.6 Oxygen;

3.5.1.7 Emergency intubation equipment;

3.5.1.8 IV solutions and IV tubing;

3.5.1.9 Sufficient ampoules of dantrolene sodium or similar FDA approved drug, if the facility utilizes anesthetic agents that trigger malignant hyperthermia;

3.5.1.10 Esophageal or precordial stethoscope;

3.5.1.11 Temperature monitoring device;

3.5.1.12 End tidal CO2 monitor;

3.5.1.13 Crash cart which shall include:

3.5.1.13.1 Appropriate resuscitative equipment; and

3.5.1.13.2 Medications for surgical, procedural or anesthetic complications;

3.5.2 Appropriate sterilization equipment; and

3.5.3 Adequate procedure room lighting.

3.6 Written informed consent is required prior to the procedure reflecting:

3.6.1 The patient's knowledge of the identified risks of the procedure (including anesthesia);

3.6.2 The consent to the procedure;

3.6.3 The licensed individual performing the procedure;

3.6.4 The type of anesthesia to be administered; and

3.6.5 The anesthesia provider.

3.7 The facility must maintain a policy/procedure for a time-out to ensure the risk of medical error is minimized.

3.8 A registered nurse with post-anesthesia care experience and certification in Advanced Cardiac Life Support or a physician/dentist/podiatrist/physician assistant/certified registered nurse anesthetist must monitor the patient until the patient has met the facility's criteria for discharge.

3.9 A physician/dentist/podiatrist must be available onsite during patient treatment and until the patients are medically discharged.

**History**
- *23 DE Reg. 125 (08/01/19)*
- *18 DE Reg. 862 (05/01/15)*
- *23 DE Reg. 125 (08/01/19)*
- *23 DE Reg. 125 (08/01/19)*
- *25 DE Reg. 770 (02/01/22)*
- *23 DE Reg. 125 (08/01/19)*
- *23 DE Reg. 125 (08/01/19)*
- *17 DE Reg. 848 (02/01/14)*
- *18 DE Reg. 862 (05/01/15)*
- *23 DE Reg. 125 (08/01/19)*
- *25 DE Reg. 770 (02/01/22)*

##### **16 Del. Admin. Code § 3335-4.0** General Requirements {#sec-3335-4.0 omnilex-key=us-de-regs-official--title-16--3335-4.0}

4.1 All records maintained by the facility shall be open to inspection by the authorized representatives of the Department.

4.2 The facility must permit photocopying of any records or other information by, or on behalf of authorized representatives of the Department, as necessary to determine or verify compliance with these regulations or accepted standards of practice. The Department shall keep patient information confidential in accordance with state and federal laws.

4.3 Report of adverse events:

4.3.1 The facility must report all adverse events to the Department within forty-eight (48) business hours of the occurrence.

4.3.2 The facility must conduct an investigation of all adverse events.

4.3.3 The facility must forward a complete investigative report to the Department within 30 calendar days of the event.

4.4 The facility must keep reports of adverse events, accidents and medical emergencies on file at the facility for a minimum of five years.

4.5 Facility procedures shall not:

4.5.1 Generally result in blood loss of more than ten percent of estimated blood volume in a patient with a normal hemoglobin; or

4.5.2 Be generally emergent or life-threatening in nature.

4.6 All personnel who provide clinical care in a facility must be qualified to perform services commensurate with appropriate levels of education, training and experience and in keeping with practice standards. Nothing in these regulations shall prohibit a licensed individual from performing procedures within his/her scope of practice.

4.7 All services shall be provided in a safe and effective manner in accordance with accepted standards of practice.

4.7.1 The facility shall maintain policies and procedures based upon accepted standards of practice.

4.8 Back-up power sufficient to ensure patient protection in the event of an emergency shall be immediately available.

4.9 There must be sufficient space in the room in which the procedure is being performed.

4.9.1 The room shall accommodate all necessary equipment and personnel allowing for expeditious access to the patient and all resuscitation and monitoring equipment.

4.10 All equipment shall be maintained and functional to ensure patient safety.

4.11 A facility that chooses to stop performing office-based surgery and voluntarily surrenders accreditation must notify the Department in writing, 30 days prior to the voluntary surrender of accreditation or cessation of office-based surgery.

**History**
- *23 DE Reg. 125 (08/01/19)*
- *18 DE Reg. 862 (05/01/15)*
- *23 DE Reg. 125 (08/01/19)*
- *23 DE Reg. 125 (08/01/19)*
- *25 DE Reg. 770 (02/01/22)*
- *23 DE Reg. 125 (08/01/19)*
- *23 DE Reg. 125 (08/01/19)*
- *17 DE Reg. 848 (02/01/14)*
- *18 DE Reg. 862 (05/01/15)*
- *23 DE Reg. 125 (08/01/19)*
- *25 DE Reg. 770 (02/01/22)*

##### **16 Del. Admin. Code § 3335-5.0** Infection Control {#sec-3335-5.0 omnilex-key=us-de-regs-official--title-16--3335-5.0}

5.1 The facility must provide and maintain a functional and sanitary environment to avoid sources and transmission of infections and communicable diseases.

5.2 The facility shall establish and implement an ongoing infection prevention and control program which shall be based upon nationally-recognized infection control guidelines/standards (i.e. CDC, AORN, etc.) to prevent, control and investigate infections and communicable diseases.

5.2.1. The ongoing infection prevention and control program must:

5.2.1.1 Include an active surveillance component that covers both patients and personnel working in the facility.

5.2.1.1.1 Surveillance includes infection detection through ongoing data collection and analysis.

5.2.1.2 Include mechanisms that result in immediate action to take preventive or corrective measures that improve the facility's infection control outcomes.

5.2.1.3 Target its plan to be specific to each particular area of the facility, including, but not limited to, the waiting room(s), the recovery room(s) and the procedure areas.

5.3 Specific Requirements for COVID-19

5.3.1 Before their start date, all new staff, vendors and volunteers must be tested for COVID-19 in accordance with Division of Public Health guidance.

5.3.2 All staff, vendors and volunteers must be tested for COVID-19 in a manner consistent with Division of Public Health guidance.

5.3.3 The facility must follow recommendations of the Centers for Disease Control and Prevention and the Division of Public Health regarding the provision of care or services to patients by staff, vendor or volunteer found to be positive for COVID-19 in an infectious stage.

5.4 The facility shall amend their policies and procedures to include:

5.4.1 Work exclusion and return to work protocols for staff tested positive for COVID-19;

5.4.2 Staff refusals to participate in COVID-19 testing;

5.4.3 Staff refusals to authorize release of testing results or vaccination status to the facility;

5.4.4 Procedures to obtain staff authorizations for release of laboratory test results to the facility to inform infection control and prevention strategies; and

5.4.5 Plans to address staffing shortages and facility demands should a COVID-19 outbreak occur.

**History**
- *23 DE Reg. 125 (08/01/19)*
- *18 DE Reg. 862 (05/01/15)*
- *23 DE Reg. 125 (08/01/19)*
- *23 DE Reg. 125 (08/01/19)*
- *25 DE Reg. 770 (02/01/22)*
- *23 DE Reg. 125 (08/01/19)*
- *23 DE Reg. 125 (08/01/19)*
- *17 DE Reg. 848 (02/01/14)*
- *18 DE Reg. 862 (05/01/15)*
- *23 DE Reg. 125 (08/01/19)*
- *25 DE Reg. 770 (02/01/22)*

##### **16 Del. Admin. Code § 3335-6.0** Medical Record {#sec-3335-6.0 omnilex-key=us-de-regs-official--title-16--3335-6.0}

6.1 A legible, comprehensive and accurate medical record must be maintained for each patient evaluated or treated.

6.2 The medical record must include:

6.2.1 Patient identifying information;

6.2.2 Patient's medical history and a physical examination:

6.2.2.1 Inclusive of the cardiorespiratory system and other systems related to the diagnosis;

6.2.2.2 Completed within 30 days prior to the procedure;

6.2.3 Diagnosis and plan of care;

6.2.4 Appropriate diagnostic reports;

6.2.5 Informed consent;

6.2.6 Documentation of the time-out;

6.2.7 Operative/procedure report;

6.2.8 Pathology reports, if applicable;

6.2.9 Outcome and follow-up plans;

6.2.10 A separate anesthesia record for each administration of anesthesia which must include:

6.2.10.1 Type of anesthesia;

6.2.10.2 Drug type, dose and route;

6.2.10.3 Time of administration;

6.2.10.4 Fluids administered;

6.2.10.5 Patient weight;

6.2.10.6 Vital signs monitoring;

6.2.10.7 Estimated blood loss;

6.2.10.8 Duration of procedure; and

6.2.10.9 Any complication or unusual event related to the procedure or anesthesia.

6.2.11 Intra-procedure and post-procedure monitoring.

6.3 The facility must ensure the security and confidentiality of the medical record in accordance with state and federal laws.

**History**
- *23 DE Reg. 125 (08/01/19)*
- *18 DE Reg. 862 (05/01/15)*
- *23 DE Reg. 125 (08/01/19)*
- *23 DE Reg. 125 (08/01/19)*
- *25 DE Reg. 770 (02/01/22)*
- *23 DE Reg. 125 (08/01/19)*
- *23 DE Reg. 125 (08/01/19)*
- *17 DE Reg. 848 (02/01/14)*
- *18 DE Reg. 862 (05/01/15)*
- *23 DE Reg. 125 (08/01/19)*
- *25 DE Reg. 770 (02/01/22)*

##### **16 Del. Admin. Code § 3335-7.0** Patient Rights {#sec-3335-7.0 omnilex-key=us-de-regs-official--title-16--3335-7.0}

7.1 The facility must post written notice of patient rights in a conspicuous place, at or near the entrance in a manner which is plainly visible and easily read by the patients (or their representatives, if applicable) waiting for treatment.

7.1.1 The facility's notice of rights must include the names, addresses, and telephone numbers of the State agencies and accrediting organization to whom patients can report complaints.

7.1.1.1 Complaints received by the Department will be investigated as appropriate.

7.1.1.2 Complainants (unless anonymous) will be notified of the outcome of any investigation.

7.2 The patient has the right to:

7.2.1 High-quality care delivered in a safe, timely, efficient and cost-effective manner and assurance the expected results can be reasonably anticipated.

7.2.2 Dignity, respect and consideration of legitimate concerns.

7.2.3 Privacy and confidentiality.

7.2.4 Be involved in all aspects of care:

7.2.4.1 Informed consent must be obtained after discussion of the risks, benefits and alternatives for the procedure.

7.2.4.2 The patient must be given information about the current diagnosis, treatment and prognosis.

7.2.5 Refuse any procedure or treatment and to be advised of the likely medical consequences of such refusal.

7.2.6 Know who will be delivering the care and the qualifications of such individuals.

7.2.7 Exercise her/his rights without being subjected to discrimination or reprisal.

7.2.8 Voice grievances regarding treatment or care that is (or fails to be) furnished.

7.2.9 Be free from all forms of abuse, mistreatment, neglect or harassment.

7.2.10 Receive care from individuals who are properly trained and competent to perform their duties.

7.2.11 Request and receive a copy of the posted written notice of the patient rights.

**History**
- *23 DE Reg. 125 (08/01/19)*
- *18 DE Reg. 862 (05/01/15)*
- *23 DE Reg. 125 (08/01/19)*
- *23 DE Reg. 125 (08/01/19)*
- *25 DE Reg. 770 (02/01/22)*
- *23 DE Reg. 125 (08/01/19)*
- *23 DE Reg. 125 (08/01/19)*
- *17 DE Reg. 848 (02/01/14)*
- *18 DE Reg. 862 (05/01/15)*
- *23 DE Reg. 125 (08/01/19)*
- *25 DE Reg. 770 (02/01/22)*

##### **16 Del. Admin. Code § 3335-8.0** Disciplinary Actions {#sec-3335-8.0 omnilex-key=us-de-regs-official--title-16--3335-8.0}

8.1 The Department may impose sanctions singly or in combination when it finds a facility has:

8.1.1 Violated any of these regulations;

8.1.2 Violated standards for safe and sanitary care in a facility;

8.1.3 Failed to correct deficiencies in accordance with a timetable submitted by the facility and agreed upon by the Department;

8.1.4 Engaged in any conduct or practices detrimental to the welfare of the patients; or

8.1.5 Refused to allow the Department access to the facility or records for the purpose of conducting inspections/surveys/investigations as deemed necessary by the Department based on the receipt of a complaint or report of an adverse event.

8.2 Disciplinary sanctions:

8.2.1 The Department may make and enforce such emergency orders as it deems necessary to protect the health and safety of the public.

8.2.1.1 If the Department determines during the course of any investigation or inspection that any facility poses an immediate and substantial risk to the health or safety of any person, the Department may order that such facility be closed until such time as it no longer poses a substantial risk.

8.2.1.1.1 An order of closure under this section shall remain in effect for a period not longer than 90 calendar days from the date of the issuance of said order, unless the facility requests a continuance of the date for the final hearing before the Department.

8.2.1.2 If the Department determines during the course of any investigation or inspection that any facility poses a possible risk to the health or safety of any person, the Department may:

8.2.1.2.1 Issue of a letter of reprimand; and/or

8.2.1.2.2 Require the facility to complete a plan of correction.

8.3 Imposition of Disciplinary Action

8.3.1 The Department may issue an order to close the facility immediately.

8.3.1.1 An order to close may apply to the performance of office-based surgery.

8.3.1.2 An order to close may apply to the facility as a whole.

8.3.2 The facility shall be notified forthwith in writing. The order to close shall be personally served upon the facility or sent by mail, return receipt requested, to the facility's last address of record.

8.3.2.1 A statement of deficiencies (identified during the investigation/inspection) will be forwarded to the facility within 48 hours of completion of the investigation/inspection.

8.3.3 In response to the order to close, the facility may:

8.3.3.1 Take no action, in which case the order to close shall remain in effect.

8.3.3.2 Take action to correct the unsafe and unsanitary practices identified during the survey.

8.3.3.2.1 The facility may submit evidence through a written plan of correction showing that the deficient practices, identified during the investigation, have been addressed and corrected.

8.3.3.2.1.1 A change of location for the facility does not nullify an order to close and an acceptable plan of correction must still be submitted.

8.3.3.2.2 The Department shall determine if the plan of correction is acceptable.

8.3.3.2.3 Once accepted, the Department shall schedule a revisit as soon as possible.

8.3.3.3 Request, in writing, an administrative hearing with the Secretary of the Department to contest the order to close.

8.3.3.3.1 Such request must be received within 20 calendar days from the date on which the order to close was issued.

8.3.3.3.1.1 As soon as possible, but in no event later than 60 calendar days after the issuance of the closure order, the Department shall convene a hearing on the reasons for closure.

8.3.3.3.1.2 The Department shall make a determination based upon the evidence presented.

8.3.3.3.1.3 A written copy of the determination and the reasons upon which it is based shall be sent to the facility within 30 calendar days.

8.3.3.3.2 A facility may request an expedited hearing.

8.3.3.3.2.1 The Department shall schedule the hearing on an expedited basis provided that the Department receives the facility's written request for an expedited hearing within five (5) calendar days from the date on which the facility received notification of the Department's decision to close the facility.

8.3.3.3.2.2 The Department shall convene an expedited hearing within 15 calendar days of the receipt by the Department of such a request.

8.3.3.3.2.3 The Department shall make a determination based upon the evidence presented.

8.3.3.3.2.4 A written copy of the determination and the reasons upon which it is based shall be sent to the facility within 30 calendar days.

8.3.4 During an administrative hearing:

8.3.4.1 The facility has the right to be represented by counsel.

8.3.4.2 All statements made shall be under oath.

8.3.4.3 The facility has the right to examine and cross-examine witnesses.

8.3.4.4 A stenographic recording will be made by a qualified court reporter. At the request and expense of any party, such record shall be transcribed with a copy to the other party.

8.3.4.5 The decision of the Department shall be based upon sufficient legal evidence. If the charges are supported by such evidence, the Department may continue, modify or revoke the closure order.

8.3.5 Upon reaching its conclusion of law and determining an appropriate disciplinary action, the Department shall issue a written decision and order in accordance with § 10128 of Title 29.

8.3.6 All decisions of the Department shall be final and conclusive. Where the facility is in disagreement with the action of the Department, the facility may appeal the Department's decision to the Superior Court within 30 days of service or of the postmarked date of the copy of the decision mailed to the facility. The appeal shall be on the record to the Superior Court and shall be as provided in §§ 10142 - 10145 of Title 29.

**History**
- *23 DE Reg. 125 (08/01/19)*
- *18 DE Reg. 862 (05/01/15)*
- *23 DE Reg. 125 (08/01/19)*
- *23 DE Reg. 125 (08/01/19)*
- *25 DE Reg. 770 (02/01/22)*
- *23 DE Reg. 125 (08/01/19)*
- *23 DE Reg. 125 (08/01/19)*
- *17 DE Reg. 848 (02/01/14)*
- *18 DE Reg. 862 (05/01/15)*
- *23 DE Reg. 125 (08/01/19)*
- *25 DE Reg. 770 (02/01/22)*

##### **16 Del. Admin. Code § 3335-9.0** Accreditation Requirements and Procedures {#sec-3335-9.0 omnilex-key=us-de-regs-official--title-16--3335-9.0}

9.1 General requirements

9.1.1 All facilities must register with the Department at least 15 days prior to the first day of operation using a form created by the Department. It will include:

9.1.1.1 The facility name;

9.1.1.2 Facility address;

9.1.1.3 Facility phone number;

9.1.1.4 A contact person; and

9.1.1.5 Acknowledgment that office-based surgery is performed in the facility.

9.1.2 No person shall establish, conduct or maintain in this State any facility without obtaining accreditation from an accrediting organization that is approved by the Department.

9.1.2.1 The Department shall maintain a list of approved accrediting organizations.

9.1.3 All facilities must provide proof of accreditation to the Department within 12 months of the first day of operation of such facility.

9.1.4 The accreditation certificate shall be posted in a conspicuous place on the facility premises, at or near the entrance, in a manner which is plainly visible and easily read by the public.

9.1.5 The facility must submit an accreditation certificate to the Department within 30 days of each accrediting organization survey.

9.1.5.1 The Department may request and the facility must submit a copy of the entire accreditation report.

9.1.5.2 Facilities required to submit a plan of correction to an accrediting organization will also be required to submit a copy of the plan of correction to the Department.

9.1.6 The accreditation organization shall report to the Department, at a minimum, all of the following regarding facilities the organization has accredited:

9.1.6.1 The findings of surveys;

9.1.6.2 The findings of complaint and incident investigations; and

9.1.6.3 Data for all facilities that perform office-based surgery.

9.2 Accreditation termination

9.2.1 Termination of accreditation may occur secondary to:

9.2.1.1 Voluntary surrender of accreditation by the facility.

9.2.1.2 Revocation of accreditation by the accrediting organization.

9.2.2 Any facility that fails to maintain accreditation shall immediately cease to operate.

9.2.2.1 The facility may be required to remain open for administrative purposes for a period of time to be determined by the Department.

9.3 Inspection

9.3.1 Unannounced inspections of any facility by authorized representatives of the Department may occur:

9.3.1.1 Anytime upon receipt of a complaint by a current facility employee or patient or upon the occurrence of any adverse event.

9.3.1.2 Anytime upon receipt of a referral from the Division of Professional Regulation.

9.3.2 Facilities certified by the Centers for Medicare and Medicaid Services (CMS) will be inspected pursuant to the process required by CMS rather than otherwise stated in these regulations.

9.4 Notice to patients

9.4.1 The facility shall notify each patient (or the patient's authorized representative) scheduled for an upcoming office-based surgery of an accreditation termination, or as directed under an order issued by the Department.

9.4.2 The facility shall include in the notification information regarding alternative healthcare providers.

9.5 Exclusions from accreditation

9.5.1 The following persons, associations or organizations are not required to obtain accreditation as facilities:

9.5.1.1 Those facilities required to be licensed under Title16 of the Delaware Code.

**History**
- *23 DE Reg. 125 (08/01/19)*
- *18 DE Reg. 862 (05/01/15)*
- *23 DE Reg. 125 (08/01/19)*
- *23 DE Reg. 125 (08/01/19)*
- *25 DE Reg. 770 (02/01/22)*
- *23 DE Reg. 125 (08/01/19)*
- *23 DE Reg. 125 (08/01/19)*
- *17 DE Reg. 848 (02/01/14)*
- *18 DE Reg. 862 (05/01/15)*
- *23 DE Reg. 125 (08/01/19)*
- *25 DE Reg. 770 (02/01/22)*

##### **16 Del. Admin. Code § 3335-10.0** Severability {#sec-3335-10.0 omnilex-key=us-de-regs-official--title-16--3335-10.0}

In the event any particular clause or section of these regulations should be declared invalid or unconstitutional by any court of competent jurisdiction, the remaining portions shall remain in full force and effect.

**History**
- *23 DE Reg. 125 (08/01/19)*
- *18 DE Reg. 862 (05/01/15)*
- *23 DE Reg. 125 (08/01/19)*
- *23 DE Reg. 125 (08/01/19)*
- *25 DE Reg. 770 (02/01/22)*
- *23 DE Reg. 125 (08/01/19)*
- *23 DE Reg. 125 (08/01/19)*
- *17 DE Reg. 848 (02/01/14)*
- *18 DE Reg. 862 (05/01/15)*
- *23 DE Reg. 125 (08/01/19)*
- *25 DE Reg. 770 (02/01/22)*

#### **3340** Free Standing Emergency Departments

##### **16 Del. Admin. Code § 3340-1.0** Purpose {#sec-3340-1.0 omnilex-key=us-de-regs-official--title-16--3340-1.0}

Delaware Department of Health and Social Services adopts these regulations pursuant to the authority vested by 16 Del.C. §122(3)p.

**History**
- *25 DE Reg. 771 (02/01/22)*
- *24 DE Reg. 692 (01/01/21)*
- *25 DE Reg. 771 (02/01/22)*

##### **16 Del. Admin. Code § 3340-2.0** Definitions {#sec-3340-2.0 omnilex-key=us-de-regs-official--title-16--3340-2.0}

The following words and terms, when used in this regulation, have the following meaning unless the context clearly indicates otherwise:

“Abuse” means the infliction of injury, unreasonable confinement, intimidation, or punishment with resulting physical harm, pain, or mental anguish and includes all of the following:

a. Physical abuse. — "Physical abuse" means the unnecessary infliction of pain or injury to a patient or resident. "Physical abuse" includes hitting, kicking, punching, slapping, or pulling hair. If any act constituting physical abuse has been proven, the infliction of pain is presumed.

b. Sexual abuse. — "Sexual abuse" includes any sexual contact, sexual penetration, or sexual intercourse, as those terms are defined in §761 of Title 11, with a patient or resident by an employee or volunteer working at a facility. It is not a defense that the sexual contact, sexual penetration, or sexual intercourse was consensual.

c. Emotional abuse. — "Emotional abuse" means the use of oral, written, or gestured language that includes disparaging and derogatory terms to patients, residents, their families, or within their hearing distance, regardless of their age, ability to comprehend, or disability. "Emotional abuse" includes the violation of resident rights and privacy through the posting of inappropriate materials on social media. "Emotional abuse" includes all of the following: ridiculing, demeaning, humiliating, or cursing at a patient or resident; punishment or deprivation; or threatening a patient or resident with physical harm.

d. 1. Medication diversion. — "Medication diversion" means the knowing or intentional interruption, obstruction, or alteration of the delivery, or administration of a prescription drug to a patient or resident, if both of the following apply:

A. The prescription drug was prescribed or ordered by a licensed independent practitioner for the patient or resident.

B. The interruption, obstruction, or alteration occurred without the prescription or order of a licensed independent practitioner.

2. "Medication diversion" does not mean conduct performed by any of the following:

A. A licensed independent practitioner or licensed health-care professional who acted in good faith within the scope of the individual's practice or employment.

B. An individual acting in good faith while rendering emergency care at the scene of an emergency or accident.

“Adverse Incident” means an event that results in unintended harm to the patient by an act of commission or omission rather than by the underlying disease or condition of the patient.

“Clinical Director” means a registered nurse, currently licensed to practice nursing pursuant to Title 24, Chapter 19 of the Delaware Code who is sufficiently qualified to provide general supervision and direction of the services offered by the FSED.

“Department” means the Delaware Department of Health and Social Services.

“Director” means a full-time physician who is board certified in emergency medicine.

“Emergency Care” means services provided in a free standing emergency department on an outpatient basis for medical conditions that include those manifested by symptoms of sufficient severity that, in the absence of immediate medical attention, could result in (1) placing the patient’s health in jeopardy, (2) serious impairment to bodily functions, (3) serious dysfunction of any bodily organ or part, or (4) development or continuance of severe pain.

“Exploitation” means the illegal or improper use of a patient’s resources or financial rights by another person, whether for profit or other advantage.

“Facility” means a free standing emergency department.

"Free Standing Emergency Department" or “FSED” means a facility, physically separate from a hospital, which is established, maintained and operated twenty-four (24) hours per day, seven (7) days per week for the purpose of providing immediate and emergency care to individuals suffering from a life-threatening medical condition. A free standing emergency department that is owned and operated by a hospital and deemed by an accreditation organization approved by the Centers for Medicare and Medicaid Services is exempt from licensure and this set of regulations.

“Governing Body” means the individual, group or corporation appointed, elected, or otherwise designated, in which the ultimate responsibility and authority for the conduct of the FSED is vested.

“Hospital” means a facility currently licensed as a hospital pursuant to Title 16, Chapter 10 of the Delaware Code.

“Incident” means a circumstance or occurrence that may be injurious to a patient or that may result in an adverse outcome to the patient.

“Medical Staff” means a physician or non-physician provider who by action of the FSED’s governing body are privileged to work in and use the facility.

“Modification of Ownership and Control” means a change of ownership or transfer of responsibility for the FSED’s operation.

“Neglect” means the failure to provide goods or services that are necessary to avoid adversely affecting the physical, mental, or emotional welfare of the patient.

“Non-physician Provider” means a person currently licensed as an advanced practice nurse pursuant to Title 24, Chapter 17 of the Delaware Code, or a person currently licensed as a physician’s assistant pursuant to Title 24, Chapter 19 of the Delaware Code.

“Patient” means a person who receives health care services from a FSED.

“Physician” means a person currently licensed as a physician by Title 24, Chapter 17 of the Delaware Code.

“Plan of Correction” means a written document that includes specific measures to correct identified problems or areas of concern; identifies strategies for implementing system improvements; and includes outcome measures to indicate the effectiveness of system improvements in reducing, controlling or eliminating identified problem areas.

“Quality Assessment and Performance Improvement” or “QAPI” means an ongoing program that measures, analyzes, and tracks quality indicators related to improving health outcomes and patient care emphasizing a multidisciplinary approach. The program implements plans and evaluates the implementation until resolution is achieved.

“Registered Nurse” means a person currently licensed as a registered nurse pursuant to Title 24, Chapter 19 of the Delaware Code.

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

“Renovation” means 1) the strengthening or upgrading of building elements, materials, equipment, or fixtures that does not result in a reconfiguration of the building spaces within; or 2) any reconfiguration of a space that affects an exit, a corridor, or any component of a means of egress; or 3) work that changes the current designated purpose or occupancy classification of a building space. Cosmetic changes such as repainting or changing carpeting are not considered renovations.

“Resident Physician” means a person who currently holds physician training licensure by Title 24, Chapter 17 of the Delaware Code.

“Serious Injury” means physical injury that creates a substantial risk of death, or that causes serious disfigurement, prolonged impairment of health or prolonged loss or impairment of the function of any bodily organ.

“Stabilization” means to provide necessary medical treatment of an emergency medical condition to ensure, within reasonable medical probability, that the condition is not likely to deteriorate materially from or during the transfer of the individual from the facility.

“Substantial Compliance” means a level of compliance with the requirements such that any identified deficiencies pose no greater risk to patient health or safety than the potential for causing minimal harm.

“Unethical Conduct” means conduct prohibited by ethical standards adopted by state or national professional organizations for their respective professions or by rules adopted by the state licensing agency for the respective profession.

“Unprofessional Conduct” means conduct prohibited under rules adopted by the state licensing agency for the respective profession.

**History**
- *25 DE Reg. 771 (02/01/22)*
- *24 DE Reg. 692 (01/01/21)*
- *25 DE Reg. 771 (02/01/22)*

##### **16 Del. Admin. Code § 3340-3.0** Licensure Requirements and Procedures {#sec-3340-3.0 omnilex-key=us-de-regs-official--title-16--3340-3.0}

3.1 General Requirements

3.1.1 No person shall establish, conduct or maintain in this State any FSED without first obtaining a license from the Department.

3.1.2 No FSED, treatment facility, office or station shall be authorized to exhibit any emergency trailblazing signs, symbols or directional signs by the Delaware Department of Transportation unless such facility has been duly licensed under the provisions of these regulations.

3.1.3 A license is not transferable from person to person, entity to entity or from one location to another.

3.1.4 The license shall be posted in a conspicuous place on the licensed premises, at or near the entrance in a manner which is plainly visible and easily read by the public.

3.1.5 Separate licenses are required for FSEDs maintained in separate locations, even though operated under the same management.

3.1.6 Any FSED that undergoes a modification of ownership and control is required to re-apply as a new FSED and must meet the current design and construction standards recognized by the Department.

3.1.7 The submission of an application is in no way a guarantee that the completed application will be accepted or that a license will be issued by the Department.

3.1.8 Patients shall not be admitted to a FSED until a license has been issued.

3.1.9 The FSED shall advise the Department in writing at least 30 calendar days prior to closure of the FSED and voluntary surrender of a license.

3.2 Application Process

3.2.1 All persons or entities wanting to apply to open a FSED shall submit to the Department the following information:

3.2.1.1 A Statement of Intent describing the services to be offered at the FSED;

3.2.1.2 A completed application for licensure;

3.2.1.3 The names, addresses and types of facilities previously and currently owned or managed by the applicant;

3.2.1.4 Identity of:

3.2.1.4.1 Each officer and director of the corporation, if the entity is organized as a corporation;

3.2.1.4.2 Each general partner or managing member, if the entity is organized as an unincorporated entity;

3.2.1.4.3 The governing body; and

3.2.1.4.4 Any officers/directors, partners, or managing members, or members of a governing body who have a financial interest in a licensee’s operation or related business.

3.2.1.5 Proof of not-for-profit status, if claiming tax-exempt status;

3.2.1.6 Disclosure of any officer, director, partner, employee, managing member or member of the governing body with a felony criminal record;

3.2.1.7 Name of the director and the person designated to act in the absence of the director;

3.2.1.8 A list of management personnel, including credentials;

3.2.1.9 A plan for providing orientation, continuing education, and training for personnel or independent contractors during the first year of operation;

3.2.1.10 Policy and procedure manuals; and

3.2.1.11 Any other information required by the Department.

3.3 Issuance of Licenses

3.3.1 Initial License

3.3.1.1 An initial license shall be granted for a period of three (3) calendar months to every FSED that completes the application process consistent with those regulations and whose policies and procedures demonstrate compliance with the rules and regulations pertaining to FSED licensure.

3.3.1.2 An initial license will permit a FSED to hire or contract with personnel and begin to offer services.

3.3.1.3 All FSED shall have an on-site survey, conducted by the Department, during the first three (3) calendar months of operation.

3.3.1.4 A FSED at the time of an initial on-site survey, must meet the definition of a free standing emergency department as contained within these regulations and must be in operation and caring for patients. Facilities that, at the time of the onsite survey, do not meet the definition of a FSED or that are not in substantial compliance with these regulations will not be granted an annual license.

3.3.1.5 An initial license may not be renewed.

3.3.2 Provisional License

3.3.2.1 A provisional license shall be granted, for a period of less than one year, to all FSEDs that:

3.3.2.1.1 Are not in substantial compliance with these rules and regulations; or

3.3.2.1.2 Fail to renew a license within the timeframe prescribed by these regulations.

3.3.2.2 Upon issuance of a provisional license, the Department shall designate the conditions and the time period in writing.

3.3.2.3 A provisional license may not be renewed unless a Plan of Correction for coming into substantial compliance with these rules and regulations has been approved by the Department and implemented by the FSED.

3.3.2.4 A license will not be granted after the provisional licensure period to any FSED that is not in substantial compliance with these rules and regulations.

3.3.3 Annual License

3.3.3.1 An annual license shall be effective for a twelve (12) month period following the date of issue and shall expire one year following such date, unless it is modified, suspended, revoked or surrendered prior to the expiration date.

3.3.3.2 All applications for renewal of licenses must be filed with the Department at least thirty (30) days prior to the expiration date of the license.

3.3.3.3 FSEDs which have not been inspected/surveyed during a licensure year may apply for, and be issued, a new license until an inspection/survey is completed.

3.3.3.4 An annual license may not be issued to a FSED which is not in substantial compliance with these regulations or whose deficient practices present an immediate threat to the health and safety of its patients.

3.4 The Department may deny a licensure renewal or suspend or revoke a license issued under these regulations on any of the following grounds:

3.4.1 Violation of any of the provisions of 16 Del.C. §122(3)p or these regulations.

3.4.2 Permitting, aiding or abetting the commission of any illegal act in the facility.

3.4.3 Conducts or practices detrimental to the welfare of a patient.

3.4.4 Imposition of a disciplinary action.

3.4.4.1 The Department shall give 20 calendar days written notice to the holder of the license, setting forth the reasons for the determination;

3.4.4.2 The disciplinary action shall become final 20 calendar days after the mailing of the notice unless the licensee, within such 20-calender-day period, shall give written notice of the FSED desire for a hearing;

3.4.4.3 If the licensee gives such notice, the FSED shall be given a hearing before the Secretary of the Department or the Secretary’s designee and may present such evidence as may be proper;

3.4.4.4 The Secretary of the Department or the Secretary’s designee shall make a determination based upon the evidence presented.

3.4.4.5 A written copy of the determination and the reasons upon which it is based shall be sent to the FSED;

3.4.4.6 The decision shall become final 20 calendar days after the mailing of the determination letter unless the licensee, within the 20-calender-day period, appeals the decision to the appropriate court of the State

3.5 Order to immediately suspend a license.

3.5.1 In the event the Department identifies activities which the Department determines present an immediate jeopardy or imminent danger to the public health, welfare and safety requiring emergency action, the Department may issue an order temporarily suspending the licensee’s license, pending a final hearing on the complaint. No order temporarily suspending a license shall be issued by the Department, with less than 24 hours prior written or oral notice to the licensee or the licensee’s attorney so that the licensee may be heard in opposition to the proposed suspension. An order of temporary suspension under this section shall remain in effect for a period not longer than 60 calendar days from the date of the issuance of said order, unless the suspended licensee requests a continuance of the date for the final hearing before the Department. If a continuance is requested, the order of temporary suspension shall remain in effect until the Department has rendered a decision after the final hearing.

3.5.2 The licensee, whose license has been temporarily suspended, shall be notified forthwith in writing. Notification shall consist of a copy of the deficiency report and the order of temporary suspension pending a hearing and shall be personally served upon the licensee or sent by mail, return receipt requested, to the licensee’s last known address.

3.5.3 A licensee whose license has been temporarily suspended pursuant to this section may request an expedited hearing. The Department shall schedule the hearing on an expedited basis provided that the Department receives the licensee’s written request for an expedited hearing within 5 calendar days from the date on which the licensee received notification of the Department’s decision to temporarily suspend the licensee’s license.

3.5.4 As soon as possible, but in no event later than 60 calendar days after the issuance of the order of temporary suspension, the Department shall convene a hearing on the reasons for suspension. In the event that a licensee, in a timely manner, requests an expedited hearing, the Department shall convene within 15 calendar days of the receipt by the Department of such a request and shall render a decision within 30 calendar days.

3.5.5 In no event shall an order of temporary suspension remain in effect for longer than 60 calendar days unless the suspended licensee requests an extension of the order of temporary suspension pending a final decision of the Department. Upon a final decision of the Department, the order of temporary suspension may be vacated in favor of the disciplinary action ordered by the Department.

3.6 Renewal of License After Suspension or Revocation

3.6.1 If and when the conditions upon which the suspension or revocation of a license are based have been corrected and after a proper inspection has been made, a new license may be granted.

3.7 Modification of Ownership and Control (MOC)

3.7.1 Any proposed MOC must be reported to the Department in writing a minimum of 30 calendar days prior to the change.

3.7.2 A MOC occurs whenever the ultimate legal authority for the responsibility of the FSED’s operation is transferred.

3.7.3 A MOC voids the current license in possession of the FSED.

3.7.4 A MOC will be treated as an initial license and the FSED must meet the current design and construction standards recognized by the Department.

3.7.5 A MOC may include but is not limited to:

3.7.5.1 Transfer of the FSED’s legal title;

3.7.5.2 Transfer of the full ownership rights;

3.7.5.3 Transfer of the majority interest;

3.7.5.4 Transfer of ownership interest that results in the owner with the majority interest becoming a minority interest owner;

3.7.5.5 Transfer or re-organization that results in an additional majority interest that is equal in ownership rights;

3.7.5.6 Transfer resulting in a measurable impact upon the operational control of the FSED;

3.7.5.7 Dissolution of any partnership that owns, or owns a controlling interest in the FSED;

3.7.5.8 Merger of a FSED owner (a corporation) into another corporation where, after the merger, the owner’s shares of capitol stock are cancelled; or

3.7.5.9 The consolidation of a corporate FSED owner with one or more corporations;

3.7.6 Transactions which do not constitute an MOC include, but are not limited to the following:

3.7.6.1 Changes in the membership of a corporate board of directors or board of trustees;

3.7.6.2 Two or more corporations merge and the originally licensed corporation survives;

3.7.6.3 Changes in the membership of a non-profit corporation; or

3.7.6.4 Corporate stock transfers or sales that do not result in a transfer of interest or ownership.

3.7.7 Applications for licensure, as a result of an MOC must include a description of:

3.7.7.1 Any actual or anticipated change in the health care services provided before the MOC;

3.7.7.2 Any actual or anticipated change in staff, including the composition of staff;

3.7.7.3 Any actual or anticipated change in the policies and procedures; and

3.7.7.4 Any change in the manner of delivery of health care services.

3.8 Fees. Fees shall be in accordance with 16 Del.C. §122(3)p.

3.9 Inspection. A representative of the Department shall periodically inspect every FSED for which a license has been issued under these regulations. Inspections by authorized representatives of the Department may occur at any time and may be scheduled or unannounced.

3.10 Whoever operates a FSED in violation of these regulations shall be fined not less than $100.00 nor more than $1000.00 for each offense. Every day such violation continues shall constitute a separate and distinct offense.

**History**
- *25 DE Reg. 771 (02/01/22)*
- *24 DE Reg. 692 (01/01/21)*
- *25 DE Reg. 771 (02/01/22)*

##### **16 Del. Admin. Code § 3340-4.0** General Requirements {#sec-3340-4.0 omnilex-key=us-de-regs-official--title-16--3340-4.0}

4.1 When a facility is classified under this law or regulation and plans to construct or renovate any building, one (1) copy of properly prepared plans and specifications for the entire FSED are to be submitted to the Department. An approval, in writing, is to be obtained before such work is begun.

4.2 All records maintained by the FSED shall be open to inspection by authorized representatives of the Department.

4.3 The FSED must permit photocopying of any records or other information by, or on behalf of authorized representatives of the Department, as necessary to determine or verify compliance with these regulations.

4.4 The term “emergency” or symbols which imply or indicate to the public that emergency medical treatment is available to individuals suffering from a life threatening medical condition shall not be used as part of the name of any facility in this State, unless the facility has been licensed by the Department as a FSED or hospital.

4.5 No policies shall be adopted by the licensee or FSED which are in conflict with these regulations.

4.6 The Department shall be notified, in writing within thirty (30) days of any changes in the director or clinical director of the facility.

4.7 The FSED must establish written policies regarding the rights and responsibilities of patients, and these policies and procedures are to be made available to patients, guardians, next of kin or sponsoring agency or agencies.

4.8 Each facility shall make available upon request to all patients or their representative, a complete statement enumerating all charges for service, materials and equipment which were furnished to the patient.

4.9 Each facility shall conspicuously post the prepayment policy. In the event of third-party payment denial, a policy statement must be developed in writing and available upon request as to the responsibility for payment.

4.10 A facility licensed under the provisions of this regulation as a "Free Standing Emergency Department", shall not refuse to render a needed, medically appropriate emergency service to any person.

4.11 A facility licensed as a FSED shall maintain the services, staff, equipment and drugs necessary to provide an appropriate medical screening evaluation and stabilization of a patient of any age who presents at the facility.

4.12 Each facility shall coordinate with the Office of Emergency Medical Services in regards to transfer agreements, communications requirements and disaster planning and preparedness.

4.13 The Office of Emergency Medical Services and the Office of Narcotics and Dangerous Drugs shall be notified by the Office of Health Facilities Licensing and Certification of any proposal of licensing of FSEDs.

4.14 The FSED must have a written transfer agreement, including a plan for transportation, in effect with one or more general acute care hospitals that provide basic or comprehensive emergency medical services wherein patients requiring more definitive care will be expeditiously transferred to receive prompt hospital care.

4.15 The FSED shall be in compliance with federal, state and local laws and codes.

4.16 The provisions of the Centers for Disease Control and Prevention Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005, are hereby adopted as the regulatory requirements for FSEDs in Delaware and are hereby referred to, and made part of this Regulation, as if fully set out herein.

4.17 The provisions of the 2018 Facility Guidelines Institute’s Guidelines for Design and Construction of Health Care Facilities, are hereby adopted as the regulatory requirements for FSEDs in Delaware and are hereby referred to, and made part of this Regulation, as if fully set out herein.

4.17.1 When a FSED is classified under this law or regulation and plans to construct or renovate any buildings, one (1) copy of the properly prepared plans and specifications for the entire FSED shall be submitted to the Department.

4.17.2 An approval, in writing shall be obtained from the Department before construction/renovation work is begun.

4.17.3 Upon completion of construction/renovation, in accordance with the plans and specifications, the Department will inspect and approve the site prior to occupancy/use by the FSED.

4.17.4 All facilities shall either be at grade level or shall be equipped with ramps and elevators to allow easy access for persons with disabilities.

4.17.5 The FSED shall comply with all local and state building codes and ordinances as pertains to this occupancy.

4.17.6 Waiver of a standard requires Department approval. Waiver requests must be made in writing, include the full justification behind the request and address issues of safety and infection control. Waivers are an exception to established standards and will only be approved for compelling reason.

4.18 The provisions of the State of Delaware Food Code, 16 DE Admin. Code 4458, are hereby adopted as the regulatory requirements for FSEDs in Delaware and are hereby referred to, and made part of this Regulation, as if fully set out herein.

4.19 The FSED may contract for services to be provided to its patients. Individuals providing services under contract must meet the same requirements as those persons employed directly by the FSED.

4.20 Major Adverse Incidents

4.20.1 A major adverse incident includes but is not limited to:

4.20.1.1 Suspected abuse, neglect, mistreatment, exploitation, solicitation or harassment of patients;

4.20.1.2 An accident that causes serious injury to a patient;

4.20.1.3 A medication error with the potential to result in adverse health outcomes for the patient;

4.20.1.4 The unexpected death of a patient while under care of the facility;

4.20.1.5 A patient stay exceeding 23 hours; and

4.20.1.6 Activation of 9-1-1.

4.20.2 Reports of major adverse incidents shall be kept on file at the FSED for a minimum of five (5) years.

4.20.3 The FSED must report all major adverse incidents to the Department within 48 hours in addition to other reporting requirements required by law.

4.20.4 Major adverse incidents must be investigated by the FSED.

4.20.5 The FSED must submit a complete investigation report to the Department within 30 calendar days of the incident.

4.21 The FSED shall participate in the Delaware Health Information Network as data senders and end users.

4.22 To receive emergency medical services patients, the FSED must comply with the requirements and procedures for medical command facility designation set forth by the Division of Public Health’s Office of Emergency Medical Services.

4.23 The provisions of the Americans with Disabilities Act of 1990 are hereby adopted as the regulatory requirements for FSEDs in Delaware and are hereby referred to, and made part of this Regulation, as if fully set out herein.

4.24 The provisions of Section 504 of the Rehabilitation Act of 1973. are hereby adopted as the regulatory requirements for FSEDs in Delaware and are hereby referred to, and made part of this Regulation, as if fully set out herein.

**History**
- *25 DE Reg. 771 (02/01/22)*
- *24 DE Reg. 692 (01/01/21)*
- *25 DE Reg. 771 (02/01/22)*

##### **16 Del. Admin. Code § 3340-5.0** Governing Body {#sec-3340-5.0 omnilex-key=us-de-regs-official--title-16--3340-5.0}

5.1 Each FSED shall have an identified, organized governing body (governing authority, owner or person or persons designated by the owner) fully responsible for the organization, management, control, and operation of the facility.

5.2 The governing body responsibilities include:

5.2.1 Appointing a qualified director in writing;

5.2.2 Appointing members of the medical and clinical staff, ensuring their competence and delineating their job responsibilities;

5.2.3 Adopting, implementing, and enforcing written policies and procedures for the total operation and all services provided by the facility;

5.2.4 Documentation of annual review and evaluation of the FSED policies and services;

5.2.5 All services furnished by the facility, whether furnished directly or under contract are provided in a safe and effective manner that permits the facility to comply with all applicable rules and standards;

5.2.6 Conducting meetings, when the governing body is more than one person, at least annually and maintaining written minutes of the meetings;

5.2.7 Adopting governing body and medical staff bylaws for the orderly development and management of the FSED.

5.2.7.1 Bylaws shall be reviewed annually by the governing body and so dated. Revisions shall be completed as necessary.

5.2.8 Determining the mission, goals, and objectives of the facility;

5.2.9 Ensuring that the physical environment protects the health and safety of patients, personnel, and the public;

5.2.10 Establishing an organizational structure and specifying functional relationships among various components of the facility;

5.2.11 Reviewing and approving the facility’s training program for staff;

5.2.12 Ensuring that all equipment utilized by facility staff or by patients is properly used and maintained per manufacturer’s recommendations;

5.2.13 Adopting, implementing and enforcing policies and procedures related to emergency planning and disaster preparedness. The governing body shall review the facility’s disaster preparedness plan at least annually;

5.2.14 Ensuring there is a quality assessment and performance improvement (QAPI) program to evaluate the provision of patient care. The governing body shall review and monitor QAPI activities quarterly;

5.2.15 Reviewing legal and ethical matters concerning the facility and its staff when necessary and responding accordingly;

5.2.16 Maintaining effective communication throughout the facility;

5.2.17 Approving all contracts or arrangements affecting the medical care provided under its auspices;

5.3 There shall be a description of each type of service offered.

5.4 The governing body shall provide for full disclosure of ownership to the Department.

**History**
- *25 DE Reg. 771 (02/01/22)*
- *24 DE Reg. 692 (01/01/21)*
- *25 DE Reg. 771 (02/01/22)*

##### **16 Del. Admin. Code § 3340-6.0** Administration/Personnel {#sec-3340-6.0 omnilex-key=us-de-regs-official--title-16--3340-6.0}

6.1 Director

6.1.1 There shall be a full-time physician serving as director who is board certified in emergency medicine.

6.1.2 The director shall have the overall authority and responsibility for the daily operation and management of the FSED.

6.1.3 The director shall be responsible for the direction, provision and quality of medical care.

6.1.4 The authority, duties and responsibilities of the director shall be defined in writing and shall include but not be limited to:

6.1.4.1 Interpretation and execution of the policies adopted by the governing body;

6.1.4.2 Program planning, budgeting, management and program evaluation;

6.1.4.3 Maintenance of the FSED’s compliance with licensure regulations and standards;

6.1.4.4 Preparation and submission of required reports;

6.1.4.5 Distribution of a written plan for the delegation of administrative responsibilities and functions in the absence of the director;

6.1.4.6 Documentation of complaints relating to the conduct or actions by employees/contractors/medical staff and action taken secondary to the complaints;

6.1.4.7 Conducting or supervising the resolution of complaints received from patients regarding the delivery of care or services; and

6.1.4.8 Reviewing policies and procedures at least annually, and reporting, in writing, to the governing body on the review.

6.1.5 The director shall designate, in writing, a person who meets the director qualifications to act in the absence of the director.

6.2 Supervision of clinical services

6.2.1 The director shall appoint, in writing, a full-time employee as the clinical director.

6.2.2 The clinical director shall be responsible for implementing, coordinating and assuring quality of patient care services.

6.2.3 The clinical director shall:

6.2.3.1 Be a registered nurse with evidence of substantial education, experience and competence in emergency nursing. The Certified Emergency Nurse (CEN) credential is preferred, but not required; and

6.2.3.2 Show evidence of competence in management/administration/supervision of the clinical services of the FSED; and

6.2.3.3 Provide general supervision and direction of the services offered by the FSED.

6.2.4 The director shall designate, in writing, a person who meets the clinical director qualifications to act in the absence of the clinical director.

6.3 Contract services

6.3.1 The FSED maintains responsibility for all services provided to the patient.

6.3.2 Services provided by the FSED through arrangements with a contractor agency or individual shall be set forth in a written contract which clearly specifies:

6.3.2.1 The services to be provided by the contractor;

6.3.2.2 The necessity to conform to all FSED policies;

6.3.2.3 The procedure for annual assurance of clinical competence of all individuals utilized under contract;

6.3.2.4 The procedure for supervision of services of the contracted individuals; and

6.3.2.5 The frequency of contract renewal.

6.3.3 The FSED must ensure that personnel and services contracted meet the requirements specified in these regulations for FSED personnel and services.

6.4 Written policies

6.4.1 Policy manuals which outline the procedures and practices of the FSED shall be prepared and followed.

6.4.2 The FSED shall establish written policies which include:

6.4.2.1 Compliance with state licensure law;

6.4.2.2 Governing body and management;

6.4.2.3 Emergency services;

6.4.2.4 Quality assessment and performance improvement;

6.4.2.5 Environment;

6.4.2.6 Medical staff;

6.4.2.7 Nursing services;

6.4.2.8 Medical records;

6.4.2.9 Pharmaceutical services;

6.4.2.10 Laboratory and radiologic services;

6.4.2.11 Patient rights;

6.4.2.12 Infection control;

6.4.2.13 Patient admission, assessment, discharge and transfer;

6.4.2.14 The investigation and documentation of incidents, accidents and major adverse incidents;

6.4.2.15 Reporting of all reportable communicable diseases to the Department; and

6.4.2.16 Employment/Personnel. Such policies shall include:

6.4.2.16.1 Qualifications, responsibilities and requirements for each job classification;

6.4.2.16.2 Pre-employment requirements;

6.4.2.16.3 Position descriptions;

6.4.2.16.4 Orientation;

6.4.2.16.5 In-service education;

6.4.2.16.6 Annual performance review and competency testing; and

6.4.2.16.7 The process of appointment to the professional staff whereby it can satisfactorily be determined that the individual is appropriately licensed and qualified for the privileges and responsibilities to be given.

6.4.3 Policies shall be made available to representatives of the Department upon request.

6.5 Personnel records

6.5.1 Records of each employee/contractor shall be available upon request by authorized representatives of the Department.

6.5.2 For all employees/contractors, the FSED shall maintain current individual personnel records on-site which shall contain at least:

6.5.2.1 Written verification of compliance with pre-employment requirements;

6.5.2.2 Documentation of clinical competence;

6.5.2.3 Evidence of current professional licensure, registration or certification as appropriate;

6.5.2.4 Educational preparation and work history;

6.5.2.5 Written performance evaluations conducted, at least, annually; and

6.5.2.6 A written and signed job description.

6.6 Staff development

6.6.1 All employees/contractors, including medical staff, are required to complete an orientation program.

6.6.2 An orientation/training program should be based on an instruction plan that includes learning objectives, clinical content and minimum acceptable performance standards, and shall include but not be limited to:

6.6.2.1 Organizational structure of the FSED;

6.6.2.2 Patient care policies and procedures;

6.6.2.3 Infection control;

6.6.2.4 Philosophy of patient care;

6.6.2.5 Patient rights;

6.6.2.6 Personnel and administrative policies;

6.6.2.7 Job description;

6.6.2.8 Disaster preparedness; and

6.6.2.9 Applicable state regulations governing the delivery of services.

6.6.3 Documentation of orientation must include the date and hours, content, and name and title of the person providing the orientation.

6.6.4 It is the responsibility of the FSED to ensure that employees/contractors are proficient to carry out the assigned care in a safe, effective and efficient manner. Nothing in these regulations is intended to restrict the practice of licensed independent practitioners practicing in accordance with Delaware law.

6.6.5 All newly hired employees and contractors must have a written validation of competency upon orientation, prior to providing care to patients, and annually thereafter.

6.6.6 Attendance records must be kept for all orientation and continuing education programs.

6.7 Medical Staff

6.7.1 Each physician practicing in the FSED shall be licensed to practice in this State and:

6.7.1.1 Be board-certified in emergency medicine;

6.7.1.2 Be board-eligible for certification in emergency medicine and attain certification within three years of completion of a residency program; or

6.7.1.3 Have at least three years of full-time clinical experience in emergency medicine within the past five years, be American Board of Medical Specialties or American Osteopathic Association certified in a medical specialty, and hold current certifications in advanced cardiac life support, advanced pediatric life support, and advanced trauma life support.

6.7.2 One (1) or more physicians shall be in attendance at the FSED at all times.

6.7.3 All members of the FSED medical staff must be:

6.7.3.1 Individually credentialed to ensure the individual is deemed qualified; and

6.7.3.2 Appointed to their position within the FSED by the governing body.

6.7.4 Medical staff privileges must be granted by the governing body, in writing.

6.7.5 Medical staff privileges must be reappraised by the FSED at least every 24 months.

6.7.5.1 Reappraisals must include assessment of current competence by the FSED Director.

6.7.6 Resident physicians and non-physician providers may work in the FSED as long as there are procedures in place for prompt consultation and communication with an on-site physician.

6.7.7 If the FSED assigns patient care responsibilities to resident physicians or non-physician providers, it must have:

6.7.7.1 Established credentialing and privileging procedures approved by the governing body; and

6.7.7.2 Policies and procedures, approved by the governing body, for overseeing and evaluating clinical activities.

6.7.8 The medical staff shall adopt, implement and enforce written bylaws to carry out its responsibilities. The bylaws shall:

6.7.8.1 Be approved by the governing body;

6.7.8.2 Include a statement of the duties and privileges of each category of medical staff (i.e. active, consultant);

6.7.8.3 Describe the organization of the medical staff; and

6.7.8.4 Include criteria for privileges to be granted and a procedure for applying the criteria to individuals requesting privileges.

6.8 Nursing services

6.8.1 There shall be an organized nursing services which must be under the direction of the clinical director.

6.8.2 Each registered nurse practicing in the FSED shall:

6.8.2.1 Be licensed as a registered nurse in this State;

6.8.2.2 Hold, or attain within 6 months of hire, certifications, or the equivalents as approved by the Department, in advanced cardiac life support and pediatric advanced life support; and

6.8.2.3 Hold and maintain current certification in Basic Cardiac Life Support.

6.8.3 There must be sufficient nursing staff with the appropriate qualifications to ensure the nursing needs of all FSED patients are met.

6.8.4 Patient care responsibilities must be delineated for all nursing service personnel.

6.8.5 Nursing services must be provided in accordance with recognized standards of practice.

6.9 There must be at least one physician that meets the requirements set forth in these regulations, and one registered nurse with current certifications, or equivalents as approved by the Department, in advanced cardiac life support and pediatric advanced life support in the FSED at all times.

6.10 There shall be adequate medical and nursing personnel qualified in emergency care to meet the written emergency procedures and needs anticipated by the facility.

6.11 Schedules, names, and telephone numbers of all physicians and others on emergency call duty, including alternates, shall be maintained. The facility shall retain all schedules for at least one year.

**History**
- *25 DE Reg. 771 (02/01/22)*
- *24 DE Reg. 692 (01/01/21)*
- *25 DE Reg. 771 (02/01/22)*

##### **16 Del. Admin. Code § 3340-7.0** Emergency Services {#sec-3340-7.0 omnilex-key=us-de-regs-official--title-16--3340-7.0}

7.1 Adequate age-appropriate supplies and equipment shall be immediately available and in readiness for use.

7.1.1 At a minimum, the age-appropriate equipment and supplies shall include:

7.1.1.1 Emergency call system;

7.1.1.2 Oxygen;

7.1.1.3 Blood pressure monitoring equipment;

7.1.1.4 Pulse oximeter, or similar device to measure blood oxygenation;

7.1.1.5 Mechanical ventilator assistance equipment, including airways, manual breathing bag, and mask;

7.1.1.6 Laryngoscopes and endotracheal tubes;

7.1.1.7 Tracheostomy trays;

7.1.1.8 Suction equipment and supplies;

7.1.1.9 Electrocardiograph;

7.1.1.10 Cardiac monitoring and defibrillator with battery pack;

7.1.1.11 Cardiac pacing system;

7.1.1.12 Central venous catheter trays;

7.1.1.13 Infusion pumps;

7.1.1.14 Intravenous fluids and administration sets;

7.1.1.15 Gastric lavage supplies, including large lumen tubes and bite blocks;

7.1.1.16 Urinary catheters and appropriate collection equipment;

7.1.1.17 Lumbar puncture sets;

7.1.1.18 Intraosseous needles and placement equipment;

7.1.1.19 Blanket warmer;

7.1.1.20 Emergency medications and supplies specified by medical staff;

7.1.1.21 Stabilization devices for spinal injuries; and

7.1.1.22 Emergency obstetrical pack.

7.2 Emergency equipment shall be tested and maintained in accordance with manufacturer’s recommendations.

7.3 If the FSED does not provide diagnosis or treatment services to victims of sexual assault, the FSED must refer a victim seeking forensic medical examination to a hospital that provides services to those victims.

7.4 All patients discharged or transferred from the FSED must receive specific, printed, legible written aftercare instructions, including any referrals.

**History**
- *25 DE Reg. 771 (02/01/22)*
- *24 DE Reg. 692 (01/01/21)*
- *25 DE Reg. 771 (02/01/22)*

##### **16 Del. Admin. Code § 3340-8.0** Infection Prevention and Control {#sec-3340-8.0 omnilex-key=us-de-regs-official--title-16--3340-8.0}

8.1 The FSED shall establish and implement an infection prevention and control program which shall be based upon nationally recognized infection prevention/control guidelines/standards (i.e. the Centers for Disease Control and Prevention).

8.2 The FSED must designate in writing, a qualified licensed healthcare professional who will lead the facility’s infection prevention and control program. The FSED must determine that the individual has had training in the principles and methods of infection prevention and control.

8.2.1 The individual designated to lead the FSED’s infection prevention and control program must develop and implement a comprehensive plan that includes actions to prevent, identify and manage infections and communicable diseases. The plan of action must include mechanisms that result in immediate action to take preventive or corrective measures that improve the FSED’s infection control outcomes.

8.3 The FSED must maintain an ongoing program to prevent, control and investigate infections and communicable diseases. As part of this program, the FSED must have an active surveillance program that covers both patients and personnel working in the FSED.

8.3.1 The infection prevention and control program shall include policies and procedures including, but not limited to the following:

8.3.1.1 A system for investigating, reporting and evaluating the occurrence of all infections or diseases which are reportable or conditions which may be related to activities and procedures of the facility and maintaining records for all patients or personnel having these infections, diseases or conditions;

8.3.1.2 Care of patients with communicable diseases;

8.3.1.3 Exclusion from work and authorization to return to work for personnel with communicable diseases;

8.3.1.4 Surveillance techniques to minimize sources and transmission of infection;

8.3.1.5 The collection, storage, handling and disposition of all pathological and infectious wastes within the facility and to be removed from the facility;

8.3.1.6 Sterilization, disinfecting and cleaning practices and techniques used in the facility, including but not limited to:

8.3.1.6.1 Care of utensils, instruments, solutions, dressings, articles and surfaces;

8.3.1.6.2 Selection, storage, use and disposition of disposable and non-disposable patient care items. Disposable items shall not be reused;

8.3.1.6.3 Methods to ensure that sterilized materials are packaged and labeled to maintain sterility and to permit identification of expiration dates;

8.3.1.6.4 Procedures for care of equipment and other devices that provide a portal of entry for pathogenic microorganisms;

8.3.1.6.5 Techniques to be used during each patient contact, including handwashing before and after each patient contact; and

8.3.1.6.6 Criteria and procedures for isolation of patients.

8.3.2 The infection prevention and control program should be specific to each particular area of the FSED.

8.4 The FSED must provide and maintain a functional and sanitary environment to avoid sources and transmission of infections and communicable diseases.

8.5 The FSED’s infection prevention and control program must be integrated into its QAPI program. Infection control data and program activities are an ongoing component of the quality improvement program and actions are taken in response to the data analyses to improve the FSED’s infection control performance.

8.6 Reportable diseases shall be reported to the Division of Public Health.

8.7 All FSED personnel shall receive orientation at the time of employment and annual in-service education regarding the infection prevention and control program.

8.8 Specific Requirements for COVID-19

8.8.1 Before their start date, all new staff, vendors and volunteers must be tested for COVID-19 in accordance with Division of Public Health guidance.

8.8.2 All staff, vendors and volunteers must be tested for COVID-19 in a manner consistent with Division of Public Health guidance.

8.8.3 The FSED must follow recommendations of the Centers for Disease Control and Prevention and the Division of Public Health regarding the provision of care or services to patients by staff, vendor or volunteer found to be positive for COVID-19 in an infectious stage.

8.9 The FSED shall amend their policies and procedures to include:

8.9.1 Work exclusion and return to work protocols for staff tested positive for COVID-19;

8.9.2 Staff refusals to participate in COVID-19 testing;

8.9.3 Staff refusals to authorize release of testing results or vaccination status to the FSED;

8.9.4 Procedures to obtain staff authorizations for release of laboratory test results to the FSED to inform infection control and prevention strategies; and

8.9.5 Plans to address staffing shortages and FSED demands should a COVID-19 outbreak occur.

**History**
- *25 DE Reg. 771 (02/01/22)*
- *24 DE Reg. 692 (01/01/21)*
- *25 DE Reg. 771 (02/01/22)*

##### **16 Del. Admin. Code § 3340-9.0** Quality Assessment Performance Improvement {#sec-3340-9.0 omnilex-key=us-de-regs-official--title-16--3340-9.0}

9.1 The FSED shall develop, implement, maintain, and evaluate an effective, ongoing facility-wide, data driven, interdisciplinary QAPI program.

9.2 The QAPI program shall reflect the complexity of the facility’s organization and services. All facility services (including those services furnished under contract or arrangement) shall focus on indicators related to improved health outcomes and the prevention and reduction of medical errors.

9.3 The FSED shall measure, analyze and track quality indicators or other aspects of performance that the facility adopts or develops that reflects processes of care and facility operations.

9.4 The facility’s ongoing QAPI program shall include:

9.4.1 An ongoing review of key elements of care using comparative and trend data to include aggregate patient data;

9.4.2 Identification of areas where performance measures or outcomes indicate an opportunity for improvement;

9.4.3 Appointment of an interdisciplinary team to:

9.4.3.1 Identify, measure, analyze and track indicators for variation from desired outcomes;

9.4.3.2 Create and implement improvement plan or plans;

9.4.3.3 Evaluate the implementation of the improvement plan or plans; and

9.4.3.4 Continue monitoring and improvement activities until resolution of the improvement plan.

9.4.4 Establishment and monitoring of quality indicators related to improved health outcomes. For each quality assessment indicator, the facility shall establish and monitor a level of performance consistent with current professional knowledge. These performance components shall influence or relate to the desired outcomes themselves. At a minimum, the following indicators shall be measured, analyzed, and tracked on a monthly basis:

9.4.4.1 Infection control (staff and patient screening, standard precautions);

9.4.4.2 Adverse incidents;

9.4.4.3 Mortality (review of each death and monitoring modality specific mortality rates);

9.4.4.4 Complaints and suggestions;

9.4.4.5 Staffing;

9.4.4.6 Safety; and

9.4.4.7 Clinical record reviews to include treatment and medication errors.

9.5 The facility shall continuously monitor performance, take actions that result in performance improvement and track performance to ensure that improvements are sustained over time. The facility shall immediately correct any identified problems that threaten the health and safety of patients.

**History**
- *25 DE Reg. 771 (02/01/22)*
- *24 DE Reg. 692 (01/01/21)*
- *25 DE Reg. 771 (02/01/22)*

##### **16 Del. Admin. Code § 3340-10.0** Environment {#sec-3340-10.0 omnilex-key=us-de-regs-official--title-16--3340-10.0}

10.1 The FSED must have a safe and sanitary environment, properly constructed, equipped and maintained to protect the health and safety of patients and staff.

10.2 Linen and laundry services

10.2.1 An adequate supply of clean linen or disposable materials shall be maintained.

10.2.2 Clean linen shall be stored, handled and transported to prevent contamination.

10.2.3 Linens shall be maintained in good repair.

10.2.4 There shall be separate and distinct areas for the storage and handling of clean and soiled linens.

10.2.5 Soiled linen shall be handled, transported, stored and processed in a manner to prevent leakage and the spread of infection.

10.2.6 Soiled linen not processed on a daily basis must be stored in a separate properly ventilated storage area.

10.2.7 Carts used to transport soiled linen must be constructed of impervious materials and must be cleaned and disinfected after each use.

10.2.8 Linen shall be processed according to nationally recommended standards for healthcare laundry.

10.2.9 For laundry reprocessed off-site:

10.2.9.1 The FSED must have a contract with a commercial or hospital laundry.

10.2.9.2 Clean linens returned to the FSED must be completely wrapped or covered to protect against contamination.

10.3 Sanitation and housekeeping

10.3.1 The FSED shall provide housekeeping services to maintain a clean, sanitary, safe environment which is free from odors.

10.3.2 Treatment areas/rooms shall be thoroughly cleaned after each use.

10.3.3 All cleaning materials, solutions, cleaning compounds and hazardous substances shall be:

10.3.3.1 Properly identified;

10.3.3.2 Stored in a safe place; and

10.3.3.3 Stored separate from patient care items and food.

10.3.4 Cleaning shall be performed in a manner which minimizes the spread of pathogenic organisms in the environment.

10.3.5 The FSED shall be kept free of insects and rodents. A contract with a pest control agency shall be executed and available for review.

10.3.6 Blood spills shall be cleaned immediately or as soon as is practical with a disposable cloth and an appropriate chemical disinfectant.

10.3.6.1 The surface shall be subjected to intermediate level disinfection in accordance with the manufacturer’s directions for use, if a commercial liquid chemical disinfectant is used.

10.3.6.2 If a solution of chlorine bleach (sodium hypochlorite) is used, the solution shall be at least 1:100 sodium hypochlorite and mixed in accordance with the manufacturer’s directions for use. The surface to be treated shall be compatible with this type of chemical treatment.

10.3.6.3 The facility shall use dedicated cleaning supplies for the cleaning of blood spills.

10.4 Waste and waste disposal

10.4.1 All waste receptacles shall be impervious, lined and clean.

10.4.2 Waste receptacles shall be conveniently available in all toilet rooms, patient areas, staff work areas, and waiting rooms.

10.4.3 All rubbish and refuse shall be collected, stored and disposed of in a manner designed to prevent transmission of disease.

10.4.4 The provisions of the State of Delaware, Department of Natural Resources and Environmental Control, Regulations Governing Solid Waste, 7 DE Admin. Code 1301, are hereby adopted as the regulatory requirements for FSEDs in Delaware and are hereby referred to, and made part of this Regulation, as if fully set out herein.

10.4.5 Regulated waste must be placed in an approved "red" bag which is marked with the International Biohazard Symbol. It must then be disposed of by a waste hauler approved by the Delaware Department of Natural Resources and Environmental Control. Sharps ready for disposal shall be disposed of in approved sharps containers. Contaminated waste which does not release liquid blood or body fluids when compressed or does not release dried blood or body fluids when handled may be placed in a receptacle and disposed of through normal, approved disposal methods.

**History**
- *25 DE Reg. 771 (02/01/22)*
- *24 DE Reg. 692 (01/01/21)*
- *25 DE Reg. 771 (02/01/22)*

##### **16 Del. Admin. Code § 3340-11.0** Medical Records {#sec-3340-11.0 omnilex-key=us-de-regs-official--title-16--3340-11.0}

11.1 The FSED shall develop and maintain a system for the collection, processing, maintenance, storage, retrieval, authentication and distribution of patient medical records. Records may exist in hard copy, electronic format, or a combination of the two media.

11.2 An accurate and legible medical record must be maintained on every individual receiving care in the FSED.

11.3 Medical records shall be protected from loss, tampering, alteration, improper destruction, and unauthorized or inadvertent use.

11.4 The FSED shall ensure that each medical record is treated with confidentiality and is maintained according to professional standards of practice.

11.5 The FSED shall designate a person to be in charge of medical records. This person’s responsibilities include, but are not limited to:

11.5.1 The confidentiality, security, and safe storage of medical records;

11.5.2 The timely retrieval of individual medical records upon request;

11.5.3 The specific identification of each patient’s medical records;

11.5.4 The supervision of the collection, processing, maintenance, storage, retrieval, and distribution of medical records; and

11.5.5 The maintenance of a predetermined organized medical record format.

11.6 Medical records shall be retained in a retrievable form until destroyed.

11.6.1 Medical records of adults (18 years of age and older) shall be retained for a minimum of five (5) years after the last date of service before being destroyed.

11.6.2 Records of minors (less than 18 years of age) shall be retained for a minimum of five (5) years after the patient reaches 18 years of age.

11.6.3 The FSED shall not destroy medical records that relate to any matter that is involved in litigation if the facility knows the litigation has not been fully resolved.

11.6.4 All records must be disposed of by shredding, burning or other similar protective measure in order to preserve the patient’s right to confidentiality.

11.6.5 The FSED must establish procedures for the notification to patients regarding the pending destruction of the medical records.

11.6.6 Documentation of medical record destruction must be maintained by the FSED.

11.7 If the FSED plans to close, the facility shall notify the Department in writing at the time of closure of the disposition of the medical records, including where the medical records will be stored, and the name, address, and phone number of the custodian of the records.

11.8 Each time the patient visits the FSED the medical record shall contain sufficient accurate information. This information must include, but is not limited to:

11.8.1 Complete patient identification;

11.8.2 Date, time and means of arrival and transfer or discharge;

11.8.3 Allergies and untoward reactions to drugs recorded in a prominent and uniform location;

11.8.4 A complete description of any care given to the patient before the patient’s arrival at the facility;

11.8.5 Pertinent history of the illness or injury and results of the physical examination, including the patient’s vital signs;

11.8.6 A complete detailed description of treatment and procedures performed in the FSED;

11.8.7 Clinical observations including the results of treatments, procedures, and tests;

11.8.8 Diagnostic impressions;

11.8.9 All medication and treatment orders signed by the prescribing physician or non-physician provider;

11.8.10 All medications administered, including the drug name, dose, route of administration and time of administration;

11.8.11 All medications dispensed to the patient by the FSED, including the drug name, dose, route and frequency of administration;

11.8.12 Documentation of a properly executed informed consent when necessary;

11.8.13 For patients with a length of stay greater than eight (8) hours, an evaluation of nutritional needs and evidence of how identified needs were met;

11.8.14 Evidence of evaluation of the patient by a physician or non-physician provider prior to discharge or transfer; and

11.8.15 Conclusion at the termination of evaluation or treatment, including final disposition, the patient’s condition on discharge or transfer, and any instructions given to the patient or family for follow-up care.

11.9 All entries in the medical record shall be legible, accurate, complete, dated, timed and authenticated by the person responsible for providing or evaluating the service provided no later than 48 hours after discharge.

11.10 To ensure continuity of care, summaries or photocopies of the patient’s medical record shall be transferred to the facility where future care will be rendered.

11.11 The FSED shall maintain the following:

11.11.1 A log identifying each individual who presents to the FSED for treatment and services including name, date and the time of arrival.

11.11.2 Statistical information concerning admissions, transfers, discharges, deaths and adverse incidents required for the effective administration of the facility.

**History**
- *25 DE Reg. 771 (02/01/22)*
- *24 DE Reg. 692 (01/01/21)*
- *25 DE Reg. 771 (02/01/22)*

##### **16 Del. Admin. Code § 3340-12.0** Pharmaceutical Services {#sec-3340-12.0 omnilex-key=us-de-regs-official--title-16--3340-12.0}

12.1 The FSED shall provide drugs, controlled substances and biologicals in a safe and effective manner in accordance with acceptable standards of practice.

12.2 The FSED must maintain compliance with all state and federal laws, regulations and guidelines governing pharmaceutical services.

12.3 The FSED must be properly registered under State and Federal Controlled Substance Acts.

12.4 Drugs, controlled substances and biologicals shall be properly stored and accessible only to authorized personnel.

12.4.1 Schedule II medication must be under double lock.

12.5 Drugs, controlled substances and biologicals must be prepared and administered according to acceptable standards of practice.

12.6 Verbal orders must be countersigned by the prescriber within 48 hours of receipt.

**History**
- *25 DE Reg. 771 (02/01/22)*
- *24 DE Reg. 692 (01/01/21)*
- *25 DE Reg. 771 (02/01/22)*

##### **16 Del. Admin. Code § 3340-13.0** Laboratory and Radiologic Services {#sec-3340-13.0 omnilex-key=us-de-regs-official--title-16--3340-13.0}

13.1 The FSED shall provide on-the-premises clinical laboratory services and diagnostic radiology services during all hours of operation.

13.2 Laboratory Services

13.2.1 Clinical laboratory services shall include collection, processing and provision of results to meet a patient’s emergency laboratory needs.

13.2.2 Laboratory Services shall comply with the Clinical Laboratory Improvement Amendments of 1988 (CLIA 1988), in accordance with the requirements specified in 42 Code of Federal Regulations §§493.1 – 493.1780.

13.2.3 When blood and blood components are stored, the FSED shall have written procedures readily available containing directions on how to maintain the blood and blood components within permissible temperatures and including instructions to follow in the event of a power failure or other disruption of refrigeration.

13.2.3.1 Blood transfusions shall be prescribed in accordance with facility policy and administered in accordance with a written protocol for the administration of blood and blood components and the use of infusion devices and ancillary equipment.

13.2.3.2 Personnel administering blood transfusions and intravenous medications shall have special training for this duty according to adopted, implemented, and enforced facility policy.

13.2.3.3 Blood and blood components shall be transfused through a sterile, pyrogen-free transfusion set that has a filter designed to retain particles potentially harmful to the recipient.

13.2.3.4 Facility staff must observe the patient for potential adverse reactions during the transfusion and for an appropriate time thereafter, and document the observations and patient’s response.

13.2.3.5 Pre-transfusion and post-transfusion vital signs shall be recorded.

13.2.3.6 Following the transfusion, the blood transfusion record or copy shall be made a part of the patient’s medical record.

13.2.4 The FSED shall establish a mechanism for ensuring that the patient’s physician or other licensed health care professional is made aware of critical lab value results, as established by the medical staff, before or after the patient is discharged. A physician or non-physician practitioner shall read, date, sign and authenticate all laboratory reports.

13.3 Radiology Services

13.3.1 The FSED shall provide radiological services including but not limited to: x-ray, computed tomography scan and ultrasound.

13.3.2 The radiology department shall meet all applicable federal, state and local laws, codes, rules, regulations and ordinances.

13.3.3 The FSED must adopt and implement policies and procedures that provide safety for patients and personnel, including but not limited to:

13.3.3.1 Adequate shielding for patients, personnel and surrounding areas;

13.3.3.2 Labeling of radioactive materials, waste and hazardous areas;

13.3.3.3 Transportation of radioactive materials between locations within the FSED;

13.3.3.4 Security of radioactive materials, including determining who may have access to radioactive materials and controlling access to radioactive materials;

13.3.3.5 Testing of equipment for radiation;

13.3.3.6 Maintenance of personal radiation monitoring devices;

13.3.3.7 Proper storage of radiation monitoring badges when not in use;

13.3.3.8 Storage of radio nuclides and radio pharmaceuticals as well as radioactive waste; and disposal of radio nuclides, unused radio pharmaceuticals, and radioactive waste; and

13.3.3.9 Methods of identifying pregnant patients.

13.3.4 Policy and procedure manuals shall include procedures for all examinations performed, infection control for the facility, treatment/examination rooms, dress codes of personnel, and cleaning of equipment.

13.3.5 The FSED must have policies and procedures in place to ensure that periodic inspections of radiology equipment are conducted and current, and that problems identified are corrected in a timely manner. The FSED must ensure that equipment is inspected in accordance with manufacturer’s instructions, federal and state laws, regulations, guidelines and FSED policy.

13.3.6 Employees/contractors must be checked periodically, by use of exposure meters or badge tests, for amount of radiation exposure.

13.3.7 Radiology services shall only be performed upon a written order of a physician or non-physician practitioner.

13.3.8 A physician shall read, date, sign and authenticate all examination reports.

**History**
- *25 DE Reg. 771 (02/01/22)*
- *24 DE Reg. 692 (01/01/21)*
- *25 DE Reg. 771 (02/01/22)*

##### **16 Del. Admin. Code § 3340-14.0** Patient Rights {#sec-3340-14.0 omnilex-key=us-de-regs-official--title-16--3340-14.0}

14.1 The FSED must provide the patient, or patient’s representative verbal and written notice of the patient’s rights in a language and manner that the patient or patient representative understands.

14.2 The patient’s rights shall be posted in a conspicuous place in the facility’s waiting room and must include the address and telephone number of the Department to which patients may report complaints.

14.3 The patient has the right to:

14.3.1 Be treated with respect, consideration and dignity;

14.3.2 Receive care in a safe setting;

14.3.3 Be provided appropriate privacy;

14.3.4 Be free from abuse, neglect and exploitation;

14.3.5 Be provided to the degree known, appropriate information concerning their diagnosis, treatment, and prognosis. When it is medically inadvisable to give such information to a patient, the information shall be provided to a person designated by the patient or to a legally authorized person;

14.3.6 Be given the opportunity to participate in decisions involving the health care, except when the patient’s participation is contradicted for medical reasons; and

14.3.7 Voice grievances regarding treatment or care that is (or fails to be) furnished.

14.4 Information shall be available to patients and staff concerning:

14.4.1 Patient rights;

14.4.2 Patient conduct and responsibilities;

14.4.3 Services available at the facility;

14.4.4 Fees for services;

14.4.5 Payment policies; and

14.4.6 Methods for expressing complaints and suggestions to the facility.

14.5 Patient records shall be treated confidentially.

14.6 Incidents of abuse, neglect, exploitation and unprofessional conduct shall be reported to the Department and appropriate regulatory agency.

14.7 Any person associated with the FSED who reasonably believes or knows of information that would reasonably cause a person to believe that an incident of abuse, neglect or exploitation perpetrated by any person has, is or will occur shall report the incident to the Department and appropriate regulatory agency.

14.8 Any person associated with the FSED who reasonably believes or knows of information that would reasonably cause a person to believe that the facility or an employee or health care professional associated with the facility has, is, or will be engaged in conduct that is or might be illegal, unprofessional, or unethical and that relates to the operation of the facility shall report the information to the Department and appropriate regulatory agency.

**History**
- *25 DE Reg. 771 (02/01/22)*
- *24 DE Reg. 692 (01/01/21)*
- *25 DE Reg. 771 (02/01/22)*

##### **16 Del. Admin. Code § 3340-15.0** Disaster Preparedness {#sec-3340-15.0 omnilex-key=us-de-regs-official--title-16--3340-15.0}

15.1 The FSED shall implement written procedures which describe staff and patient actions to manage potential medical and non-medical emergencies, including but not limited to fire, equipment failure, power outages, medical emergencies, and natural or other disasters which are likely to threaten the health, welfare, or safety of facility patients, staff, or the public.

15.2 The FSED shall maintain a disability inclusive written disaster preparedness plan for natural and other disasters specific to the facility. The plan shall be based on an assessment of the probability and type of disasters in the region and the local resources available to the facility.

15.2.1 Contact shall be made annually with the local disaster management representative to assess the need to revise the plan and to ensure that local agencies are aware of the facility, its provision of life-saving treatment, and the patient population served.

15.2.2 The plan shall include:

15.2.2.1 Procedures to minimize harm to patients and staff along with ensuring safe facility operations;

15.2.2.2 Provisions for responsibility of direction and control, communications, alerting and warning systems, evacuation, and closure.

15.2.3 The FSED shall designate in writing a person to monitor and coordinate disaster preparedness activities.

15.2.4 The FSED shall maintain documentation of the monitoring and coordination of disaster preparedness activities.

**History**
- *25 DE Reg. 771 (02/01/22)*
- *24 DE Reg. 692 (01/01/21)*
- *25 DE Reg. 771 (02/01/22)*

##### **16 Del. Admin. Code § 3340-16.0** Fire Safety {#sec-3340-16.0 omnilex-key=us-de-regs-official--title-16--3340-16.0}

16.1 The FSED shall comply with the rules and regulations of the State Fire Prevention Commission.

16.2 The FSED must be inspected annually by the fire marshal having jurisdiction, and all applications for license (new and renewal) must include documentation, dated within the past 12 months, indicating compliance to all applicable fire code regulations.

16.3 Failure to provide documentation from the fire marshal having jurisdiction, dated within the past 12 months, indicating compliance to all applicable fire code regulations shall be grounds for licensure action.

16.4 An evacuation floor plan shall be prominently and conspicuously posted for display throughout the facility in areas that are readily visible to patients, staff, and visitors.

16.5 All employees shall be trained in procedures to be followed in the event of a fire or fire-related emergency. Training shall be:

16.5.1 Part of the initial employee orientation; and

16.5.2 Conducted annually thereafter.

16.6 The FSED shall conduct one fire drill per shift per quarter.

16.6.1 Fire drills shall include the transmission of the fire alarm signal and simulation of the emergency fire condition, simulation of evacuation of patients and other occupants, and use of fire-fighting equipment.

16.6.2 Written reports shall be maintained to include evidence of patient and staff participation.

**History**
- *25 DE Reg. 771 (02/01/22)*
- *24 DE Reg. 692 (01/01/21)*
- *25 DE Reg. 771 (02/01/22)*

##### **16 Del. Admin. Code § 3340-17.0** Severability {#sec-3340-17.0 omnilex-key=us-de-regs-official--title-16--3340-17.0}

Should any section, sentence, clause or phrase of these regulations be legally declared unconstitutional or invalid for any reason, the remainder of said regulations shall not be thereby affected.

**History**
- *25 DE Reg. 771 (02/01/22)*
- *24 DE Reg. 692 (01/01/21)*
- *25 DE Reg. 771 (02/01/22)*

#### **3345** Personal Assistance Services Agencies

##### **16 Del. Admin. Code § 3345-1.0** Definitions {#sec-3345-1.0 omnilex-key=us-de-regs-official--title-16--3345-1.0}

The following words and terms, when used in this regulation, should have the following meaning unless the context clearly indicates otherwise:

“Activities of Daily Living” means the tasks for self-care which are performed either independently, with supervision, or with assistance. Activities of daily living include but are not limited to ambulating, transferring, grooming, bathing, dressing, eating and toileting. Assistance with transfers is not permitted if the consumer is unable to physically assist with the transfer (i.e. use of transfer boards, mechanical lifts are not permitted).

“Agency” means a personal assistance services agency licensed by the Department of Health and Social Services.

“Appropriate Capacity” means an individual’s ability to comprehend both the nature and consequences of one's acts.

“Change of Ownership (CHOW)” see "Modification of Ownership and Control (MOC)".

“Companion” means a person who provides social interaction for an individual primarily in the individual’s place of residence. A companion may provide such services as cooking, housekeeping, errands, etc.

“Complaint” means a consumer issue that can be immediately addressed by staff who are present at the time of the complaint.

“Consumer” means a person, person’s spouse, parent, legal guardian, or legal custodian of a person under 18, or any legal guardian, legal custodian or surrogate of a person who is an adult, requesting and receiving personal assistance services as defined in this chapter, primarily in the consumer’s residence.

“Consumer Record” means a written account of all services provided to a consumer by the personal assistance services agency, as well as other pertinent information necessary to provide care.

“Contractor” means an individual (subcontractor, independent contractor or other designation used) that does not meet the definition of employee, who holds a valid business license and provides services for the agency.

“Department” means the Delaware Department of Health and Social Services.

“Direct Care Worker” means those individuals (aide, assistant, caregiver, technician or other designation used) employed by or under contract to a personal assistance services agency to provide personal care services, companion services, homemaker services, transportation services and those services as permitted in 24 Del.C. Section 1921(a)(15) to consumers. The direct care worker provides these services to an individual primarily in their place of residence.

“Director” means a job-descriptive term used to identify the individual appointed by the governing body to act on its behalf in the overall management of the personal assistance services agency. Job titles may include administrator, superintendent, director, executive director, president, vice-president, or executive vice-president. The director shall have at least an associates degree plus 2 years healthcare or home care supervisory experience. A Director in place as of June 1, 2020 will be exempt from this requirement.

“Full-Time” means the established hours of the personal assistance services agency.

“Governing Body or Other Legal Authority” means the individual, partnership, agency, group, or corporation designated to assume full legal responsibility for the policy determination, management, operation and financial liability of the personal assistance services agency.

“Grievance” means a written or verbal report of a concern that is made to the agency by a consumer. A grievance cannot be immediately resolved by staff present at the time of the report.

"Healthcare Experience" means the direct participation of an individual in the maintenance or improvement of health via the prevention, diagnosis, treatment, recovery, or cure of disease, illness, injury, and other physical and mental impairments in patients.

"Healthcare Facility" means any facility licensed under 16 Del.C. Ch. 10 or 11.

"Home Care Experience" means the provision of services that do not require the judgment and skills of a licensed nurse or other healthcare professional. The services are limited to individual assistance with, or supervision of activities of, daily living and instrumental activities of daily living.

“Homemaker” means a person who performs household chores for an individual primarily in the individual’s place of residence. Household chores may include but are not necessarily limited to housekeeping, meal preparation and shopping.

“Home Visit” is a visit to the consumer's residence by an agency director, or designee, for the purpose of initial consumer need evaluation and update and revision of the service plan.

“Immediate Jeopardy” means a crisis situation in which the health and safety of consumers is at risk. It is a deficient practice which indicates an inability to furnish safe care and services.

“Legal Entity” means a business organizational structure that is recognized as such by Title 6 or Title 8 of the Delaware Code.

“License” means a license issued by the Department.

“Licensee” means the individual, corporation, or legal entity with whom rests the ultimate responsibility for maintaining approved standards for the personal assistance services agency.

“Majority Interest” means the largest percentage of ownership interest.

“Medication Administration” means the process whereby a single dose of a prescription or non-prescription medication is given to a consumer by a direct care worker. The responsible caregiver must provide prepackaged medication. The responsible caregiver must provide the direct care worker with written instructions regarding the administration procedure.

“Medication Reminder” means a verbal prompt to the consumer to take their medication. A medication reminder does not include the administration of or any physical contact with the medication.

“Minority Interest” means any percentage of ownership less than the majority interest.

“Modification of Ownership and Control (MOC)” means the sale, purchase, transfer or re-organization of ownership rights.

“Office” means the physical location in which the business of the personal assistance services agency is conducted and in which the records of personnel, contractors and consumers of the agency are stored. The office shall be located in the State of Delaware.

“Owner” means an individual or legal entity with ownership rights of the agency.

“Ownership” means the state or fact of exclusive possession and control of the agency.

“Ownership Interest” means the percentage of ownership an individual or legal entity possesses.

“Personal Assistance Services” means the provision of services for compensation that do not require the judgment and skills of a licensed nurse or other professional. The services are limited to individual assistance with/or supervision of activities of daily living, companion services, transportation services, homemaker services, reporting changes in consumer's condition, medication reminders and completing reports. Medication administration is permitted if all of the requirements under subsection 5.4.3 of these regulations are met. These services do not require physician's orders.

“Personal Assistance Services Agency” means any business entity or subdivision thereof, whether public or private, proprietary or not-for-profit, which refers direct care workers to provide personal assistance services to individuals primarily in their home or private residence.

“Plan of Correction” means a personal assistance services agency's written response to findings of regulatory non-compliance. Plans must adhere to the format specified by the licensing agency, must include acceptable timeframes in which deficiencies will be corrected and must be approved by the licensing agency.

“Prepackaged Medication” means medication labeled with the consumer name, medication name, medication dosage, and the date and time the medication is to be administered. Each medication must be packaged separately and labeled.

“Representative” means a person acting on behalf of the consumer, as permitted by Delaware law.

“Residence” means the domicile of the consumer either personally owned by that consumer or considered the place of residence of that consumer.

“Responsible Caregiver” means an individual 18 years old or older who is the primary caretaker for an adult consumer.

“Safety Supervision” means the services provided by a direct care worker to help prevent wandering and other occurrences sometimes associated with dementia or diminished capacity.

“Serious Injury” means physical injury that creates a substantial risk of death, or that causes serious disfigurement, serious impairment of health or serious loss or impairment of the function of any bodily organ.

“Service Area” means the county in the state of Delaware in which the agency office is located and the county or counties in the state of Delaware which are immediately adjacent.

“Service Plan” means a written plan that specifies scope, frequency and duration of services.

"Telehealth Mechanism" means the use of information exchange from 1 site to another via an electronic interactive telecommunication system. Telehealth is provided with specialized equipment at each site including real-time streaming via the use of video streaming and audio equipment. The telecommunications must permit real-time encryption of the interactive audio and video exchanges with the personal assistance services agency. The consumer must consent to the use of telehealth.

**History**
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *27 DE Reg. 43 (07/01/23)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *15 DE Reg. 220 (08/01/11)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *27 DE Reg. 43 (07/01/23)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *27 DE Reg. 43 (07/01/23)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *23 DE Reg. 1033 (06/01/20)*
- *25 DE Reg. 772 (02/01/22)*
- *11 DE Reg. 196 (08/01/07)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *25 DE Reg. 772 (02/01/22)*
- *27 DE Reg. 43 (07/01/23)*

##### **16 Del. Admin. Code § 3345-2.0** Licensing Requirements and Procedures {#sec-3345-2.0 omnilex-key=us-de-regs-official--title-16--3345-2.0}

2.1 General Requirements

2.1.1 No person shall establish, conduct, or maintain in this State any personal assistance services agency without first obtaining a license from the Department.

2.1.2 A separate license shall be required for each office maintained by a personal assistance services agency.

2.1.3 The personal assistance services agency shall advise the Department in writing at least 30 calendar days prior to any change in office location.

2.1.4 Any agency that undergoes a change of ownership is required to re-apply as a new agency.

2.1.5 A license is not transferable from person to person or from entity to entity.

2.1.6 The license shall be posted in a conspicuous place on the licensed premises.

2.1.7 The agency shall only provide services in the service area.

2.1.7.1 The agency may provide personal assistance services to a consumer during time-limited travel outside the service area.

2.2 Application Process

2.2.1 All persons or entities applying for a license shall submit a written statement of intent to the Department describing the services to be offered by the agency and requesting a licensure application from the Department.

2.2.1.1 The issuance of an application form is in no way a guarantee that the completed application will be accepted or that a license will be issued by the Department.

2.2.1.2 No person or entity shall hold themselves out to the public as being a personal assistance services agency until a license has been issued.

2.2.2 In addition to a completed application for licensure, applicants shall submit to the Department the following information:

2.2.2.1 The names, addresses and types of facilities owned or managed by the applicant;

2.2.2.2 A copy of the applicant's policies and procedures manual as outlined in subsection 4.3;

2.2.2.3 Identity of:

2.2.2.3.1 Each officer and director of the corporation if the entity is organized as a corporation;

2.2.2.3.2 Each general partner or managing member if the entity is organized as an unincorporated entity;

2.2.2.3.3 The governing body;

2.2.2.3.4 Proof of not-for-profit status if claiming tax-exempt status; and,

2.2.2.3.5 Any officers/directors, partners, or managing members, or members of a governing body who have a financial interest of 5% or more in a licensee's operation or related businesses;

2.2.2.4 Disclosure of any officer, director, partner, employee, direct care worker, managing member, or member of the governing body with a felony criminal record;

2.2.2.5 Name of the individual (director/administrator/etc.) who is responsible for the management of the personal assistance services agency;

2.2.2.6 A list of management personnel, including credentials;

2.2.2.7 A copy of the test to be given to each direct care worker, as required by subsection 4.5;

2.2.2.8 Proof of insurance and bonding as required in Section 7.0.

2.2.2.9 Any other information required by the Department.

2.3 Issuance of Licenses

2.3.1 Initial license

2.3.1.1 An initial license shall be granted for a period of 90 calendar days to every agency that completes the application process consistent with these regulations.

2.3.1.2 All personal assistance services agencies shall have an on-site survey during the first 90 days of operation. A personal assistance services agency, at the time of an initial on-site survey, must meet the definition of a personal assistance services agency as contained within these regulations and must be in operation and caring for consumers. Personal assistance services agencies that, at the time of an on-site survey, do not meet the definition of a personal assistance services agency or that are not in substantial compliance with these regulations will not be granted a license.

2.3.1.3 An initial license will permit an agency to hire or contract with direct care workers and establish a consumer caseload.

2.3.1.4 An initial license may not be renewed.

2.3.2 Provisional license

2.3.2.1 A provisional license may be granted, for a period of less than 1 year, to all personal assistance services agencies that:

2.3.2.1.1 Are not in substantial compliance with these regulations; or

2.3.2.1.2 Fail to renew a license within the timeframe prescribed by these regulations.

2.3.2.2 The Department shall designate the conditions and the time period under which a provisional license is issued.

2.3.2.3 A provisional license issued to an agency that is not in substantial compliance with these regulations may not be renewed unless a plan of correction has been approved by the Department and implemented by the personal assistance services agency.

2.3.2.4 A license will not be granted after the provisional licensure period to any agency that is not in substantial compliance with these regulations.

2.3.2.5 A license will be granted to the personal assistance services agency after the provisional licensure period if:

2.3.2.5.1 The agency has regained substantial compliance with these regulations and

2.3.2.5.2 The agency fulfilled the expectations of the plan of correction that was created to address the deficient practices that gave rise to the license action.

2.3.3 Annual License

2.3.3.1 An annual license shall be granted, for a period of 1 year (12 months) to all personal assistance services agencies which are and remain in substantial compliance with these regulations.

2.3.3.2 An annual license shall be effective for a 12-month period following date of issue and shall expire 1 year following the issue date, unless it is: modified to a provisional license, suspended, revoked, or surrendered prior to the expiration date.

2.3.3.3 Existing personal assistance services agencies must apply for licensure at least 30 calendar days prior to the expiration date of the license.

2.3.3.4 A license may not be issued to a personal assistance services agency;

2.3.3.4.1 Which does not meet the definition of a personal assistance services agency as contained within these regulations;

2.3.3.4.2 Which is not in substantial compliance with these regulations; or

2.3.3.4.3 Whose deficient practices present an immediate threat to the health and safety of its consumers.

2.4 Disciplinary proceedings

2.4.1 The Department may impose any of the following sanctions (subsection 2.4.2 of this section) singly or in combination when it finds a licensee or former licensee is guilty of any offense described herein:

2.4.1.1 Violated any of these regulations;

2.4.1.2 Failed to submit a reasonable timetable for correction of deficiencies;

2.4.1.3 Exhibited a pattern of cyclical deficiencies which extends over a period of 2 or more years;

2.4.1.4 Failed to correct deficiencies in accordance with a timetable submitted by the applicant and agreed upon by the Department;

2.4.1.5 Engaged in any conduct or practices detrimental to the welfare of the consumers;

2.4.1.6 Exhibited incompetence, negligence, or misconduct in operating the personal assistance services agency or in providing services to individuals;

2.4.1.7 Mistreated or abused individuals cared for by the personal assistance services agency; or

2.4.1.8 Refused to allow the Department access to the agency or records for the purpose of conducting inspections/surveys/investigations as deemed necessary by the Department.

2.4.2 Disciplinary sanctions include:

2.4.2.1 Permanently revoke a license.

2.4.2.2 Suspend a license.

2.4.2.3 Issue a letter of reprimand.

2.4.2.4 Place a licensee on provisional status and require the licensee to:

2.4.2.4.1 Report regularly to the Department upon the matters which are the basis of the provisional status.

2.4.2.4.2 Limit practice to those areas prescribed by the Department.

2.4.2.4.3 Suspend new intakes and admissions.

2.4.2.5 Refuse a license.

2.4.2.6 Refuse to renew a license.

2.4.2.7 The Department may request the Superior Court to impose a civil penalty of not more than $5,000 for a violation of these regulations. Each day a violation continues constitutes a separate violation.

2.4.2.7.1 In lieu of seeking a civil penalty, the Department, in its discretion, may impose an administrative penalty of not more than $5,000 for a violation of these regulations. Each day a violation continues constitutes a separate violation.

2.4.2.7.2 In determining the amount of any civil or administrative penalty imposed, the Court or the Department shall consider the following factors:

2.4.2.7.2.1 The seriousness of the violation, including the nature, circumstances, extent and gravity of the violation and the threat or potential threat to the health or safety of a consumer;

2.4.2.7.2.2 The history of violations committed by the person or the person's affiliates, agents, employees, or controlling persons;

2.4.2.7.3 The efforts made by the agency to correct the violations;

2.4.2.7.4 Any misrepresentation made to the Department; and

2.4.2.7.5 Any other matter that affects the health, safety or welfare of a consumer.

2.4.2.8 Or otherwise discipline.

2.4.3 Imposition of Disciplinary Action

2.4.3.1 Before any disciplinary action under this chapter is taken (except as authorized by subsection 2.4.4):

2.4.3.1.1 The Department shall give 20 calendar days written notice to the holder of the license, setting forth the reasons for the determination.

2.4.3.1.2 The disciplinary action shall become final 20 calendar days after the mailing of the notice unless the licensee, within such 20 calendar-day period, shall give written notice of the agency's desire for a hearing.

2.4.3.1.3 If the licensee gives such notice, the agency shall be given a hearing before the Secretary of the Department or the Secretary’s designee and may present such evidence as may be proper.

2.4.3.1.4 The Secretary of the Department or the Secretary’s designee shall make a determination based upon the evidence presented.

2.4.3.1.5 A written copy of the determination and the reasons upon which it is based shall be sent to the agency.

2.4.3.1.6 The decision shall become final 20 days after the mailing of the determination letter unless the licensee, within the 20 day period, appeals the decision to the appropriate court of the State.

2.4.4 Order to immediately suspend a license

2.4.4.1 In the event the Department identifies activities which the Department determines present an immediate or imminent danger to the public health, welfare and safety requiring emergency action, the Department may issue an order temporarily suspending the licensee's license, pending a final hearing on the complaint. No order temporarily suspending a license shall be issued by the Department, with less than 24 hours prior written or oral notice to the licensee or the licensee's attorney so that the licensee may be heard in opposition to the proposed suspension. An order of temporary suspension under this section shall remain in effect for a period not longer than 60 days from the date of the issuance of said order, unless the suspended licensee requests a continuance of the date for the final hearing before the Department. If a continuance is requested, the order of temporary suspension shall remain in effect until the Department has rendered a decision after the final hearing.

2.4.4.2 The licensee, whose license has been temporarily suspended, shall be notified forthwith in writing. Notification shall consist of a copy of the deficiency report and the order of temporary suspension pending a hearing and shall be personally served upon the licensee or sent by certified mail, return receipt requested, to the licensee's last known address.

2.4.4.3 A licensee whose license has been temporarily suspended pursuant to this section may request an expedited hearing. The Department shall schedule the hearing on an expedited basis provided that the Department receives the licensee's request for an expedited hearing within 5 calendar days from the date on which the licensee received notification of the Department's decision to temporarily suspend the licensee's license.

2.4.4.4 As soon as possible, but in no event later than 60 days after the issuance of the order of temporary suspension, the Department shall convene for a hearing on the reasons for suspension. In the event that a licensee, in a timely manner, requests an expedited hearing, the Department shall convene within 15 days of the receipt by the Department of such a request and shall render a decision within 30 days.

2.4.4.5 In no event shall an order of temporary suspension remain in effect for longer than 60 days unless the suspended licensee requests an extension of the order of temporary suspension pending a final decision of the Department. Upon a final decision of the Department, the order of temporary suspension shall be vacated in favor of the disciplinary action ordered by the Department.

2.4.5 Termination of license

2.4.5.1 Termination of a license to provide services as a personal assistance services agency occurs secondary to:

2.4.5.1.1 Revocation of a license or the voluntary surrender of a license in avoidance of revocation action.

2.4.5.1.2 Termination of rights to provide services extends to:

2.4.5.1.2.1 Agency;

2.4.5.1.2.2 Owners;

2.4.5.1.2.3 Officers/Directors, partners, managing members, or members of a governing body who have a financial interest of 5% or more in the personal assistance services agency; and

2.4.5.1.2.4 Corporation officers.

2.5 Modification of Ownership and Control (MOC)

2.5.1 Any proposed MOC must be reported to the Department a minimum of 30 calendar days prior to the change.

2.5.2 A MOC voids the current license in possession of the agency.

2.5.3 A MOC may include but is not limited to:

2.5.3.1 Transfer of full ownership rights.

2.5.3.2 Transfer of the majority interest.

2.5.3.3 Transfer of ownership interests that result in the owner with the majority interest becoming a minority interest owner.

2.5.3.4 Transfer or re-organization that results in an additional majority interest that is equal in ownership rights.

2.5.3.5 Transfer resulting in a measurable impact upon the operational control of the agency.

2.6 Fees. Fees shall be in accordance with 16 Del.C. §122 (3)x.

2.7 Inspection. A representative of the Department shall periodically inspect every personal assistance services agency for which a license has been issued under this chapter. Inspections by authorized representatives of the Department may occur at any time and may be scheduled or unannounced.

2.8 Notice to Consumers. The personal assistance services agency shall notify each consumer or the consumer's authorized representative, and any third-party payers at least 30 calendar days before the voluntary surrender of its license or as directed under an order of denial, revocation, or suspension of license issued by the Department.

2.9 Exclusions from Licensure

2.9.1 The following persons, associations or organizations are not required to obtain a personal assistance services agency license:

2.9.1.1 Those individuals who contract directly with a consumer to provide services for that consumer, where the consumer pays the individual for services rendered and neither the consumer nor the individual pays an agency on a periodic basis.

2.9.1.2 Those agencies that provide only durable medical equipment and supplies for in-home use.

2.9.1.3 Those agencies that provide staff to licensed personal assistance services agencies, such as temporary employment/staffing agencies.

2.9.1.3.1 Temporary employment/staffing agencies may not provide services under direct agreements with consumers.

2.9.1.3.2 Temporary employment/staffing agencies must be contractually bound to perform services under the contracting providers' direction and supervision.

2.9.1.3.3 Temporary staff working for a licensed provider must meet the requirements of these regulations.

2.9.1.4 Any visiting nurse service or personal assistance services conducted by and for those who rely upon spiritual means through prayer alone for healing in accordance with the tenets and practices of a registered church or religious denomination.

2.9.1.5 An agency which solely provides services as defined in 16 Del.C. Ch. 94, the Community Based Attendant Services Act.

2.9.1.6 A home health agency which solely provides services defined in 16 Del.C. §122(3)o.

**History**
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *27 DE Reg. 43 (07/01/23)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *15 DE Reg. 220 (08/01/11)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *27 DE Reg. 43 (07/01/23)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *27 DE Reg. 43 (07/01/23)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *23 DE Reg. 1033 (06/01/20)*
- *25 DE Reg. 772 (02/01/22)*
- *11 DE Reg. 196 (08/01/07)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *25 DE Reg. 772 (02/01/22)*
- *27 DE Reg. 43 (07/01/23)*

##### **16 Del. Admin. Code § 3345-3.0** General Requirements {#sec-3345-3.0 omnilex-key=us-de-regs-official--title-16--3345-3.0}

3.1 The personal assistance services agency shall neither knowingly admit, nor continue to care for, consumers whose needs cannot be met by a personal assistance services agency.

3.2 The personal assistance services agency shall establish written policies regarding the rights and responsibilities of consumers.

3.3 The personal assistance services agency shall establish policies and procedures that address the handling and documentation of incidents, accidents and medical emergencies.

3.4 Reports of incidents, accidents and medical emergencies shall be kept on file at the agency for a minimum of 6 years.

3.5 The personal assistance services agency shall establish policies which control the exposure of consumers and staff to persons with communicable diseases.

3.6 A procedure including the consumers and families right to report concerns/complaints to the Department at a telephone number established for that purpose, shall be established to enable consumers and their families or representatives, if any, to have their concerns addressed without fear of reprisal.

3.7 The personal assistance services agency shall advise the Department in writing within 15 calendar days following any change in the designation of the director/administrator or other management personnel within the agency.

3.8 The personal assistance services agency may contract for services to be provided to its consumers by direct care workers. Individuals providing services under contract must meet the same requirements as the direct care workers employed by the agency.

3.9 The director or a designee of any agency shall be available to consumers at all times during the operating hours of the personal assistance services agency.

3.10 The agency shall have policies and an operational system which assure uninterrupted implementation of the service plan. In furtherance of this requirement, the agency shall, at a minimum: 1) maintain a sufficient pool of qualified direct care workers to fulfill service plans and provide scheduled services; and 2) develop and maintain a back-up system to provide substitute direct care workers if regularly scheduled direct care workers are unavailable.

3.11 The personal assistance services agency shall permit photocopying of any records or other information by authorized representatives of the Department, as necessary to determine or verify compliance with these regulations.

3.12 Prior to the provision of personal care services in a healthcare facility, the personal assistance services agency must:

3.12.1 Disclose the personal assistance services agency’s and the direct care worker's status with respect to attendant tax, worker's compensation and liability insurance obligations, insurance coverage or the lack thereof to each healthcare facility in which services are provided.

3.12.2 Obtain written permission from each healthcare facility in which personal care services will be provided.

3.13 The personal assistance services agency must not use the word "healthcare", or any other language which implies or indicates the provision of healthcare services, in its title or in its advertising.

3.14 The agency shall be in compliance with federal, state and local laws and codes.

**History**
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *27 DE Reg. 43 (07/01/23)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *15 DE Reg. 220 (08/01/11)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *27 DE Reg. 43 (07/01/23)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *27 DE Reg. 43 (07/01/23)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *23 DE Reg. 1033 (06/01/20)*
- *25 DE Reg. 772 (02/01/22)*
- *11 DE Reg. 196 (08/01/07)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *25 DE Reg. 772 (02/01/22)*
- *27 DE Reg. 43 (07/01/23)*

##### **16 Del. Admin. Code § 3345-4.0** Administration {#sec-3345-4.0 omnilex-key=us-de-regs-official--title-16--3345-4.0}

4.1 Agency Director

4.1.1 Every agency shall have a full-time agency director.

4.1.2 The director shall appoint, in writing, a similarly qualified person to act in the director's absence. A designee in place at the time of the final publication of these regulations will be exempt from this requirement.

4.1.3 The director shall have full authority and responsibility to plan, staff, direct and implement the programs and manage the affairs of the agency.

4.1.4 The director must ensure that the personal assistance services agency adheres to its policies and procedures.

4.2 Purchase of Contracted Services

4.2.1 The personal assistance services agency maintains responsibility for all services provided to the consumer.

4.2.2 The personal assistance services agency shall establish a written contractual arrangement with a contractor for the provision of all services which are not provided directly by employees of the agency.

4.3 Written Policies

4.3.1 The personal assistance services agency shall have written policies regarding qualifications, responsibilities and requirements for employment/referral for each job classification.

4.3.2 The written policies shall include but not be limited to:

4.3.2.1 Pre-employment/referral requirements;

4.3.2.2 Position descriptions;

4.3.2.3 Orientation policy and procedure for all direct care workers;

4.3.2.4 Annual performance review and competency testing policy and procedure; and

4.3.2.5 Program review and evaluation of its program.

4.3.3 Policies shall be reviewed and dated annually and revised as necessary.

4.4 Personnel and Direct Care Worker Records

4.4.1 Records of all personnel, including each direct care worker shall be kept current and available upon request by authorized representatives of the Department.

4.4.2 For all personnel, including direct care workers, the agency shall maintain individual records which shall contain at least:

4.4.2.1 Written verification of compliance with pre-employment/referral requirements;

4.4.2.2 Documentation of competence;

4.4.2.3 Educational preparation and work history;

4.4.2.4 Written performance evaluations annually; and

4.4.2.5 A letter of appointment specifying conditions of employment/referral.

4.4.2.6 Health History

4.4.2.6.1 Minimum requirements for pre-employment/referral and annual tuberculosis (TB) testing are those currently recommended by the Centers for Disease Control and Prevention of the U.S. Department of Health and Human Services.

4.4.2.6.2 No person, including volunteers, found to have active tuberculosis in an infectious stage shall be permitted to give care or service to consumers.

4.4.2.6.3 Any person having a positive skin test but a negative X-ray must complete a statement annually attesting that they have experienced no symptoms which may indicate active TB infection.

4.4.2.6.4 A report of all test results and all attestation statements shall be on file at the agency.

4.4.2.6.5 All new personnel, including direct care workers shall be required to have a physical examination prior to providing care:

4.4.2.6.5.1 The physical examination must have been completed within 12 months prior to employment/referral; and

4.4.2.6.5.2 A copy of the physical examination shall be maintained in the individual's file.

4.4.2.6.6 Any individual who cannot adequately perform the duties required or who may jeopardize the health or safety of the consumers shall be relieved of their duties and removed from the agency until such time as the condition is resolved. This includes infections of a temporary nature.

4.5 Orientation and Testing

4.5.1 All direct care workers are required to complete an orientation program given by the Agency before providing services to a consumer.

4.5.2 The orientation program shall include but not be limited to:

4.5.2.1 Organizational structure of the agency;

4.5.2.2 Agency consumer care policies and procedures;

4.5.2.3 Philosophy of consumer care;

4.5.2.4 Description of consumer population and geographic location served;

4.5.2.5 Consumer rights;

4.5.2.6 Agency personnel and administrative policies;

4.5.2.7 Principles of good nutrition;

4.5.2.8 Process of growth, development and aging;

4.5.2.9 Principles of infection control;

4.5.2.10 Observation, reporting and documentation of consumer status;

4.5.2.11 Maintaining a least restrictive environment;

4.5.2.12 Verbal/non-verbal communication skills;

4.5.2.13 Principles of body mechanics;

4.5.2.14 The needs of the elderly and persons with disabilities;

4.5.2.15 Activities of daily living;

4.5.2.16 Introduction to common assistive technology;

4.5.2.17 Meal planning, food purchasing and preparation of meals, including special diets;

4.5.2.18 Information on the emotional and physical problems accompanying illness, disability or aging;

4.5.2.19 Principles and practices in maintaining a clean, healthy, pleasant and safe environment that encourages morale building and self-help;

4.5.2.20 Items requiring referral to the personal assistance services agency, including changes in the consumer's condition or family situation;

4.5.2.21 Confidentiality of consumer information;

4.5.2.22 Service plan specific description;

4.5.2.23 Applicable state regulations governing the delivery of personal assistance services to consumers.

4.5.2.24 Dementia-specific training must include: communications with persons diagnosed as having Alzheimer’s disease or other forms of dementia; the psychological, social, and physical needs of those persons; and safety measures which need to be taken with those persons.

4.5.3 All direct care workers must pass a competency test prior to providing care to consumers and annually thereafter.

4.5.3.1 The competency test must include questions addressing the competencies listed in subsection 4.5.2.

4.5.3.2 It is the responsibility of the personal assistance services agency to ensure that direct care workers are proficient to carry out the care assigned in a safe, effective and efficient manner.

4.5.4 A personal assistance services agency that provides services to persons diagnosed as having Alzheimer’s disease or other forms of dementia shall provide annual dementia-specific training to all direct care workers. The mandatory training must include: communicating with persons diagnosed as having Alzheimer’s disease or other forms of dementia; the psychological, social, and physical needs of those persons; and safety measures which need to be taken with those persons.

4.6 A direct care worker that has successfully completed a Department approved administration of medications training program may administer medication to a consumer if all other requirements specified in these regulations are met.

**History**
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *27 DE Reg. 43 (07/01/23)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *15 DE Reg. 220 (08/01/11)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *27 DE Reg. 43 (07/01/23)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *27 DE Reg. 43 (07/01/23)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *23 DE Reg. 1033 (06/01/20)*
- *25 DE Reg. 772 (02/01/22)*
- *11 DE Reg. 196 (08/01/07)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *25 DE Reg. 772 (02/01/22)*
- *27 DE Reg. 43 (07/01/23)*

##### **16 Del. Admin. Code § 3345-5.0** Consumer Care Management {#sec-3345-5.0 omnilex-key=us-de-regs-official--title-16--3345-5.0}

5.1 Admission/Intake

5.1.1 The personal assistance services agency shall have written policies governing intake procedures of consumers to agency services, referral of direct care workers and case closures.

5.1.2 The intake policies shall be discussed with each consumer or the consumer's representative.

5.1.3 The personal assistance services agency shall disclose to all consumers the personal assistance services agency's and the direct care worker's status with respect to attendant tax, worker's compensation and liability insurance obligations, insurance coverage or the lack thereof. Disclosure of this information shall be on a form developed by the Department.

5.1.4 There shall be a written agreement between the consumer and the personal assistance services agency. The agreement shall:

5.1.4.1 Specify the services to be provided by the agency, including but not limited to: hours per day or week and days per week, transportation agreements as appropriate, emergency procedures and procedures for termination of services.

5.1.4.2 Specify financial agreement which shall minimally include:

5.1.4.2.1 A description of services purchased and the associated cost;

5.1.4.2.2 An acceptable method of payment for these services; and

5.1.4.2.3 An outline of the billing procedures.

5.1.4.3 Be signed by the consumer or their representative and the representative of the personal assistance services agency.

5.1.4.4 Be given to the consumer or representative and a copy shall be kept at the agency in the consumer record.

5.1.4.5 Be reviewed and updated as necessary to reflect any change in the terms.

5.2 Home Visits

5.2.1 An initial home visit and consumer evaluation shall be performed by the agency director, or designee.

5.2.2 The initial home visit must be performed in the consumer's residence prior to the provision of services. The purpose of the home visit is to determine whether the agency has the ability to provide the necessary services in a safe manner.

5.2.3 At a minimum, the following must be evaluated and included in an itemized written description of the consumer prior to providing personal assistance services:

5.2.3.1 Physical condition, including ability to perform activities of daily living and sensory limitations;

5.2.3.2 Social situation, including living arrangements and the availability of family and community support; and

5.2.3.3 Mental status, including any cognitive impairment and known psychiatric, emotional and behavioral problems.

5.2.4 Follow-up home visits shall occur at regular intervals based upon the consumer's condition and needs, but no less often than every 90 calendar days.

5.2.4.1 Every other follow up visit must be completed in person.

5.2.4.2 Follow up visits not completed in person must be completed by a telehealth mechanism.

5.2.5 A follow-up home visit, performed by the agency director or designee, shall be conducted when the needs of the consumer change which indicate a revision to the service plan is needed.

5.2.6 The results of the initial home visit and follow-up home visits shall become a permanent part of the consumer's record.

5.3 Service Plan

5.3.1 The personal assistance services agency shall provide services in accordance with a written service plan developed under the supervision of the agency director.

5.3.2 A service plan shall be developed at intake based upon the initial home visit of the consumer.

5.3.3 The service plan shall be developed in consultation with the consumer or the consumer's representative.

5.3.4 The service plan shall be reviewed no less often than every 90 calendar days and revised as necessary.

5.4 Scope of Services

5.4.1 Competent consumers who do not reside in a medical facility or a facility regulated pursuant to 16 Del.C. Ch. 11 may delegate personal care services to direct care workers provided:

5.4.1.1 The nature of the service/task is not excluded by law or other state or federal regulation.

5.4.1.2 The services/tasks are those competent consumers could normally perform themselves but for functional limitation.

5.4.1.3 The delegation decision is entirely voluntary.

5.4.2 Personal assistance services shall be limited by the following:

5.4.2.1 Skin Care

5.4.2.1.1 Skin care which is preventive rather than therapeutic may be provided and may include: application of non-medicated or non-prescribed lotions or creams, massaging of non-reddened areas and application of preventive spray on unbroken skin areas that may be susceptible to development of pressure sores. Also permitted is the application of band aids to minor skin breaks.

5.4.2.1.2 Skin care which may not be provided includes sterile invasive procedures involving a wound or anatomical site and application of prescription medications.

5.4.2.2 Nail Care

5.4.2.2.1 Fingernail care includes: soaking of nails and filing/polishing of nails.

5.4.2.2.2 Fingernail care may not be provided in the presence of medical conditions that may involve peripheral circulatory problems or loss of sensation. Toenail care may not be provided.

5.4.2.3 Mouth Care

5.4.2.3.1 Mouth care includes denture care and basic oral hygiene.

5.4.2.3.2 Mouth care may not be provided when the consumer is unconscious or when oral suctioning is required.

5.4.2.4 Shaving

5.4.2.4.1 Shaving may be performed only with the consumer's personal electric razor.

5.4.2.4.2 Shaving may not be performed on an area where there is the presence of an injury or infection.

5.4.2.5 Feeding

5.4.2.5.1 Feeding includes assistance with eating by mouth, using common or adaptive feeding utensils.

5.4.2.5.2 Feeding may not be provided when oral suctioning is also needed or when there is a high risk of choking that could result in the need for emergency measures such as cardiopulmonary resuscitation. Tube and syringe feeding are not permitted.

5.4.2.6 Adult Transfers

5.4.2.6.1 Assistance with transfer may be provided when the consumer has sufficient balance and strength to assist with the transfer to some extent.

5.4.2.6.2 Assistance with transfer is not permitted if the consumer is unable to assist with the transfer.

5.4.2.7 Bladder Care

5.4.2.7.1 Bladder care includes assistance to and from the bathroom; assistance with bedpans, urinals or commodes; and changing of pads or diapers used for the care of incontinence.

5.4.2.7.2 Bladder care does not include insertion or removal of a foley or suprapubic catheter; care of a foley or suprapubic catheter; and care for an ostomy.

5.4.2.8 Bowel Care

5.4.2.8.1 Bowel care includes assistance to and from the bathroom; assistance with bedpans or commodes; and changing of pads or diapers used for the care of incontinence.

5.4.2.8.2 Bowel care does not include digital stimulation; enemas; and care for an ostomy.

5.4.3 Medication Administration Authorized by a Responsible Caregiver

5.4.3.1 A responsible caregiver with appropriate capacity may authorize a direct care worker to administer prescription or non-prescription medications to an adult consumer if all of the following are met:

5.4.3.1.1 The responsible caregiver and personal assistance services agency enter into an agreement regarding the administration of medication. The agreement must include confirmation by the responsible caregiver that both the medication to be administered and the process for administering the medication are safe and appropriate.

5.4.3.1.2 The responsible caregiver provides prepackaged medication to be given by the direct care worker by date and time and provides direct care worker with written instructions regarding the administration procedure.

5.4.3.1.2.1 Each medication must be packaged separately and labeled with the consumer name, medication name, medication dosage and date and time to be administered. The responsible caregiver may decide which medication is to be given to the adult consumer by the direct care worker.

5.4.3.1.3 Medications may not be administered via the following routes:

5.4.3.1.3.1 Injection;

5.4.3.1.3.2 Intravenous therapy;

5.4.3.1.3.3 Through the rectum or vagina;

5.4.3.1.3.4 Through a catheter; or

5.4.3.1.3.5 Through a feeding tube, including nasogastric, gastrostomy, or jejunostomy tube.

5.4.3.1.4 Medications listed as Schedule II or Schedule IV under Subchapter 11 of Chapter 47 of Title 16 of Delaware Code may not be administered by a direct care worker.

5.5 Records and Reports

5.5.1 There shall be a separate record maintained at the personal assistance services agency for each consumer which shall contain:

5.5.1.1 Intake data including:

5.5.1.1.1 Consumer's name;

5.5.1.1.2 Consumer's birth date;

5.5.1.1.3 Consumer's home address;

5.5.1.1.4 Consumer's identification for purposes of third-party billing, if applicable.

5.5.1.1.5 Consumer's date of intake;

5.5.1.1.6 Consumer's primary physician's name, address and telephone number; and

5.5.1.1.7 Names, addresses and telephone numbers of family members, friends, or other designated people to be contacted in the event of illness or an emergency.

5.5.1.2 Request for Services or Consumer Intake Form;

5.5.1.3 Records of home visits (initial and follow-up);

5.5.1.4 Individual service plan (initial and reviews);

5.5.1.5 Direct care worker activity logs documenting services provided on a daily basis;

5.5.1.6 A copy of the written agreement between the consumer and the personal assistance services agency including any updates made to the original reflecting changes in services or arrangements;

5.5.1.7 Written acknowledgment that the consumer or the consumer's representative has been fully informed of the consumer's rights;

5.5.1.8 Consumer satisfaction survey results.

5.5.1.9 Signed disclosure form required by subsection 5.1.3; and

5.5.1.10 Case closure documents.

5.5.2 Direct care worker activity logs shall contain the following information:

5.5.2.1 Dates on which services are provided;

5.5.2.2 Hours of services provided;

5.5.2.3 Types of services provided; and

5.5.2.4 Observations/problems/comments, as necessary.

5.5.2.5 If medication administration services are provided to the consumer:

5.5.2.5.1 The direct care worker who administers medication to the consumer must document in writing the medication name, dosage, date and time administered; and

5.5.2.5.2 Provide this documentation to the agency.

5.5.3 Activity logs shall be signed and dated by the direct care worker on the day that the service is rendered.

5.5.4 Copies of all activity logs shall be electronically available or maintained at the residence of the consumer.

5.5.5 Original activity log notes must be incorporated into the consumer's record located at the Agency no less often than every 2 weeks.

5.5.6 All agency records shall be available at all times for review by authorized representatives of the Department and to legally authorized persons; otherwise consumer records shall be held confidential. The consent of the consumer or his representative if the consumer is incapable of making decisions shall be obtained before any personal information is released from his records as authorized by these regulations or Delaware law.

5.5.7 The personal assistance services agency records shall be retained in a retrievable form until destroyed.

5.5.7.1 Records of adults (18 years of age and older) shall be retained for a minimum of 6 years after the last date of service before being destroyed.

5.5.7.2 Records of minors (less than 18 years of age) shall be retained for a minimum of 6 years after the consumer reaches eighteen (18) years of age.

5.5.7.3 All records must be disposed of by shredding, burning, or other similar protective measure in order to preserve the consumers' rights of confidentiality.

5.5.7.4 Documentation of record destruction must be maintained by the personal assistance services agency.

5.5.8 Records shall be protected from loss, damage and unauthorized use.

5.5.9 All notes and reports in the consumer's record shall be legibly written in ink or typed, dated and signed by the recording person with his full name and title.

5.5.10 The personal assistance services agency must develop acceptable policies for authentication of any computerized records.

5.5.11 The agency must have written policies regarding the use and removal of records and the conditions for release of information.

5.5.12 Report of Major Adverse Incidents

5.5.12.1 The personal assistance services agency must report all major adverse incidents occurring in the presence of a direct care worker involving a consumer to the Department within 48 hours in addition to other reporting requirements required by law.

5.5.12.2 A major adverse incident includes but is not limited to:

5.5.12.2.1 Suspected abuse, neglect, mistreatment, financial exploitation, solicitation or harassment;

5.5.12.2.2 An accident that causes serious injury to a consumer;

5.5.12.2.3 The unexpected death of a consumer;

5.5.12.2.4 Medication diversion; and

5.5.12.2.5 Medication error or omission.

5.5.12.3 Major adverse incidents must be investigated by the Agency. A complete report will be forwarded to the Department within 30 calendar days of occurrence or of the date that the agency first became aware of the incident.

5.5.13 The personal assistance services agency must ensure all consumer records are accurate and complete.

5.6 Case Closure

5.6.1 The consumer or the consumer's representative shall be informed of and participate in planning for case closure.

5.6.2 The personal assistance services agency shall develop a written plan of case closure which includes a summary of services provided and outlines the services needed by the consumer upon case closure.

5.6.3 When an agency decides to close a case against that consumer's wishes, a minimum of 2 weeks’ notice will be provided to permit the consumer to obtain an alternate service provider. Exceptions to the 2-week notice provision would include:

5.6.3.1 The closure of a case when service goals have been met;

5.6.3.2 The closure of a case when service needs undergo a change which necessitates transfer to a higher level of care;

5.6.3.3 The closure of a case when there is documented non-compliance with the service plan or the admission agreement (including, but not limited to, non-payment of justified charges); or

5.6.3.4 The closure of a case when activities or circumstances in the home jeopardize the welfare and safety of the personal assistance services agency direct care worker.

**History**
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *27 DE Reg. 43 (07/01/23)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *15 DE Reg. 220 (08/01/11)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *27 DE Reg. 43 (07/01/23)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *27 DE Reg. 43 (07/01/23)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *23 DE Reg. 1033 (06/01/20)*
- *25 DE Reg. 772 (02/01/22)*
- *11 DE Reg. 196 (08/01/07)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *25 DE Reg. 772 (02/01/22)*
- *27 DE Reg. 43 (07/01/23)*

##### **16 Del. Admin. Code § 3345-6.0** Consumer Rights {#sec-3345-6.0 omnilex-key=us-de-regs-official--title-16--3345-6.0}

6.1 The personal assistance services agency shall establish and implement policies and procedures regarding the rights and responsibilities of consumers.

6.2 The personal assistance services agency must provide the consumer with a written notice of the consumer's rights and responsibilities during the initial home visit or before initiation of services.

6.3 Each consumer shall have the right to:

6.3.1 Be treated with courtesy, consideration, respect and dignity;

6.3.2 Be encouraged and supported in maintaining one's independence to the extent that conditions and circumstances permit and to be involved in a program of services designed to promote personal independence;

6.3.3 Self-determination and choice, including the opportunity to participate in developing one's service plan;

6.3.4 Privacy and confidentiality;

6.3.5 Be protected from abuse, neglect, mistreatment, financial exploitation, solicitation and harassment;

6.3.6 Voice grievances without discrimination or reprisal;

6.3.7 Be fully informed, as evidenced by the consumer's written acknowledgment of these rights, of all regulations regarding consumer conduct and responsibilities;

6.3.8 Be fully informed, at the time of admission into the program, of services and activities available and related charges, including the disclosure required by subsection 5.1.3; and

6.3.9 Be served by individuals who are competent to perform their duties.

6.4 The agency must establish a process for prompt resolution of consumer/representative grievances, which must include:

6.4.1 The procedure for the submission of a written or verbal grievance;

6.4.2 The timeframes for review of the grievance and the provision of a response; and

6.4.3 A written notice of the decision to the consumer/representative that contains the name of the agency contact person, the steps taken on behalf of the consumer to investigate the grievance, the results of the grievance process, and the date of completion.

**History**
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *27 DE Reg. 43 (07/01/23)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *15 DE Reg. 220 (08/01/11)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *27 DE Reg. 43 (07/01/23)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *27 DE Reg. 43 (07/01/23)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *23 DE Reg. 1033 (06/01/20)*
- *25 DE Reg. 772 (02/01/22)*
- *11 DE Reg. 196 (08/01/07)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *25 DE Reg. 772 (02/01/22)*
- *27 DE Reg. 43 (07/01/23)*

##### **16 Del. Admin. Code § 3345-7.0** Insurance and Bonding {#sec-3345-7.0 omnilex-key=us-de-regs-official--title-16--3345-7.0}

7.1 The personal assistance services agency shall have appropriate insurance coverage in force to compensate consumers for injuries and losses resulting from services provided by the agency.

7.2 The following types and minimum amounts of coverage shall be in force at all times:

7.2.1 General liability insurance covering personal property damages, bodily injury, libel and slander:

7.2.1.1 $1 million comprehensive general liability per occurrence; and

7.2.1.2 $500,000 single limit coverage.

**History**
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *27 DE Reg. 43 (07/01/23)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *15 DE Reg. 220 (08/01/11)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *27 DE Reg. 43 (07/01/23)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *27 DE Reg. 43 (07/01/23)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *23 DE Reg. 1033 (06/01/20)*
- *25 DE Reg. 772 (02/01/22)*
- *11 DE Reg. 196 (08/01/07)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *25 DE Reg. 772 (02/01/22)*
- *27 DE Reg. 43 (07/01/23)*

##### **16 Del. Admin. Code § 3345-8.0** Disaster Preparedness {#sec-3345-8.0 omnilex-key=us-de-regs-official--title-16--3345-8.0}

8.1 Each personal assistance services agency shall prepare and maintain a comprehensive emergency management plan that is consistent with the national standards (i.e. FEMA, ASPR, TRACIE) and consistent with the local and state plans.

8.2 The plan shall:

8.2.1 Provide for continuing personal assistance services during an emergency that interrupts consumer care or services in the consumer’s home; and

8.2.2 Describe how the personal assistance services agency establishes and maintains an effective response to emergencies and disasters, including:

8.2.2.1 Notification of staff when emergency response measures are initiated;

8.2.2.2 Provision for communication with and between staff members, local emergency management agencies, the state emergency management agency and consumers;

8.2.2.3 Provision for a backup system;

8.2.2.4 Identification of resources necessary to continue essential care and services; and

8.2.2.5 Prioritization of consumer care needs and services.

8.3 All agency staff must be oriented to the disaster preparedness plan(s). Records of staff attendance must be maintained for 6 years.

8.4 A copy of the disaster preparedness plan or plans shall be available to all staff.

8.5 Each personal assistance services agency shall inform consumers and consumers’ representative, upon admission, of the agency’s procedures during and immediately following an emergency.

**History**
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *27 DE Reg. 43 (07/01/23)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *15 DE Reg. 220 (08/01/11)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *27 DE Reg. 43 (07/01/23)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *27 DE Reg. 43 (07/01/23)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *23 DE Reg. 1033 (06/01/20)*
- *25 DE Reg. 772 (02/01/22)*
- *11 DE Reg. 196 (08/01/07)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *25 DE Reg. 772 (02/01/22)*
- *27 DE Reg. 43 (07/01/23)*

##### **16 Del. Admin. Code § 3345-9.0** Infection Prevention and Control Program {#sec-3345-9.0 omnilex-key=us-de-regs-official--title-16--3345-9.0}

9.1 The agency shall establish and implement an infection prevention and control program which shall be based upon Centers for Disease Control and Prevention and other nationally recognized infection prevention and control guidelines. The infection prevention and control program must cover all services provided by the agency, including provision of the appropriate personal protective equipment for all customers and staff.

9.2 The individual designated to lead the agency's infection prevention and control program must develop and implement a comprehensive plan that includes actions to prevent, identify, and manage infections and communicable diseases. The plan must include mechanisms that result in immediate action to take preventive or corrective measures that improve the agency's infection control outcomes.

9.3 All agency staff shall receive orientation at the time of employment and annual in-service education regarding the infection prevention and control program.

9.4 Specific Requirements for COVID-19

9.4.1 Before their start date, all new staff, vendors and volunteers must be tested for COVID-19 in accordance with Division of Public Health guidance.

9.4.2 All staff, vendors and volunteers must be tested for COVID-19 in a manner consistent with Division of Public Health guidance.

9.4.3 The agency must follow recommendations of the Centers for Disease Control and Prevention and the Division of Public Health regarding the provision of care or services to consumers by staff, vendor or volunteer found to be positive for COVID-19 in an infectious stage.

9.5 The agency shall amend their policies and procedures to include:

9.5.1 Work exclusion and return to work protocols for staff tested positive for COVID-19;

9.5.2 Staff refusals to participate in COVID-19 testing;

9.5.3 Staff refusals to authorize release of testing results or vaccination status to the agency;

9.5.4 Procedures to obtain staff authorizations for release of laboratory test results to the agency to inform infection control and prevention strategies; and

9.5.5 Plans to address staffing shortages and agency demands should a COVID-19 outbreak occur.

**History**
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *27 DE Reg. 43 (07/01/23)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *15 DE Reg. 220 (08/01/11)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *27 DE Reg. 43 (07/01/23)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *27 DE Reg. 43 (07/01/23)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *23 DE Reg. 1033 (06/01/20)*
- *25 DE Reg. 772 (02/01/22)*
- *11 DE Reg. 196 (08/01/07)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *25 DE Reg. 772 (02/01/22)*
- *27 DE Reg. 43 (07/01/23)*

##### **16 Del. Admin. Code § 3345-10.0** Severability {#sec-3345-10.0 omnilex-key=us-de-regs-official--title-16--3345-10.0}

In the event any particular clause or section of these regulations should be declared invalid or unconstitutional by any court of competent jurisdiction, the remaining portions shall remain in full force and effect.

**History**
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *27 DE Reg. 43 (07/01/23)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *15 DE Reg. 220 (08/01/11)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *27 DE Reg. 43 (07/01/23)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *27 DE Reg. 43 (07/01/23)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *23 DE Reg. 1033 (06/01/20)*
- *25 DE Reg. 772 (02/01/22)*
- *11 DE Reg. 196 (08/01/07)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*
- *25 DE Reg. 772 (02/01/22)*
- *27 DE Reg. 43 (07/01/23)*

#### **3350** Skilled Home Health Agencies (Licensure)

##### **16 Del. Admin. Code § 3350-1.0** Definitions {#sec-3350-1.0 omnilex-key=us-de-regs-official--title-16--3350-1.0}

The following words and terms, when used in this regulation, should have the following meaning unless the context clearly indicates otherwise:

“Activities of daily living” means the tasks for self-care which are performed either independently, with supervision or with assistance. Activities of daily living include ambulating, transferring, grooming, bathing, dressing, eating and toileting.

“Agency” means a home health agency licensed by the Department.

“Allowable provider” means a person currently licensed as an advanced practice nurse pursuant to 24 Del.C. Ch. 17, or a person currently licensed as a physician’s assistant pursuant to 24 Del.C. Ch. 19.

“Audiologist” means an individual who is licensed to practice audiology pursuant to 24 Del.C. Ch. 37 and who offers the services to the public under any title or description of services incorporating the words "audiologist”, "hearing clinician”, "hearing therapist”, "aural rehabilitator" or any other similar title or description of service.

“Audiology aide” means an individual who is certified by the Council of Accreditation of Occupational Hearing Conservationists pursuant to 24 Del.C. Ch. 37 and who performs services only under the direct supervision of an audiologist licensed in this State.

“Audiology services” means those services defined pursuant to 24 Del.C. Ch. 37.

“Bylaws” means a set of rules adopted by a home health agency for governing the agency’s operation.

“Caregivers” means those individuals employed by or under contract to a home health agency to provide personal care services or health care services to patients.

“Change of ownership (CHOW)” see “Modification of ownership and control (MOC)”.

“Clinical Director” means a registered nurse who is sufficiently qualified to provide general supervision and direction of the services offered by the home health agency and who has at least 1 year of home health care experience and at least 1 year of administrative or supervisory health care experience. The "Clinical Director" and "Director" may be the same individual if that individual is dually qualified.

“Companion” means a person who provides social interaction for an individual primarily in her/his place of residence. A companion may provide such services as cooking, housekeeping, errands, etc.

“Complaint” means a formal or informal written or verbal notification of patient issues that can be immediately addressed by staff who are present at the time of the complaint.

“Contractor” means an entity or individual that does not meet the definition of employee, who holds a valid business license and provides services for the agency.

“Department” means the Delaware Department of Health and Social Services.

“Dietitian” means an individual who engages in the provision of nutrition services pursuant to 24 Del.C. Ch. 38. The terms nutritionist and dietitian are used interchangeably.

“Director” means the individual appointed by the governing body to act on its behalf in the overall management of the home health agency. The director shall:

(1) Have a baccalaureate degree with 5 years health care experience and at least 1 year supervisory experience (full-time or equivalent) in home health care, or

(2) Be a registered nurse with 5 years health care experience and at least 1 year of supervisory experience (full-time or equivalent) in home health care.

"Full-time" means the established business hours of the home health agency.

“Governing Body or Other Legal Authority” means the individual, partnership, agency, group, or corporation designated to assume full legal responsibility for the policy determination, management, operation and financial liability of the home health agency.

“Grievance” means a formal or informal written or verbal complaint that is made to the agency by a patient, or the patient’s representative. A grievance cannot be immediately resolved by staff present at the time of the complaint.

“Health care experience” means the direct participation of an individual in the maintenance or improvement of health via the prevention, diagnosis, treatment, recovery, or cure of disease, illness, injury, and other physical and mental impairments in patients.

"Health care facility" means any facility that is licensed under 16 Del.C. Ch. 10 or 11.

“Home health agency” or “HHA” means any business entity or sub-division thereof, whether public or private, proprietary or not-for-profit, which provides, to an individual primarily in their place of residence, 2 or more home care services, 1 of which must be either licensed nursing services or home health aide services.

“Home health aide” means a non-licensed person who provides personal care services, companion services, homemaker services and who may perform tasks delegated by a licensed nurse as permitted by 24 Del.C. Ch. 19. A home health aide (A) has at least 1 year of practical experience in a Department licensed or approved hospital, nursing home, or home care setting; or (B) has satisfactorily completed an appropriate home care course which includes the training requirements contained within these regulations; or (C) is a student nurse pursuing a degree in nursing who has completed the clinical practicum portion of their training.

“Home health aide care plan” means a written plan developed by the nurse or professional therapist that specifies the tasks that are to be performed by the aide primarily in the patient’s residence. The written plan specifies scope, frequency and duration of services.

“Home health aide services” means services, provided to an individual primarily in their place of residence, that are limited to personal care services, companion services, homemaker services, medication reminders and tasks delegated by a licensed nurse as permitted by 24 Del.C. Ch. 19.

“Home health care experience” means the provision of services by a home health agency to meet the needs of patients being cared for in their residence for an illness or injury.

“Home health care services” means services, provided to an individual primarily in her/his place of residence, that include but are not limited to: (A) licensed nursing services; (B) physical therapy services; (C) speech therapy services; (D) audiology services; (E) occupational therapy services; (F) nutritional services; (G) social services; or (H) home health aide services.

“Homemaker” means a person who performs household chores for an individual primarily in her/his place of residence. Household chores may include but are not necessarily limited to housekeeping, meal preparation and shopping.

“Immediate jeopardy” means a crisis situation in which the health and safety of patients is at risk. It is a deficient practice which indicates an inability to furnish safe care and services.

“Legal entity” means a business organizational structure that is recognized as such by 6 Del.C. or 8 Del.C.

“License” means a license issued by the Department.

“Licensed clinical social worker” means an individual licensed pursuant to 24 Del.C. Ch. 39.

“Licensed nursing services” means those services defined pursuant to 24 Del.C. Ch. 19.

“Licensee” means the individual, corporation or legal entity with whom rests the ultimate responsibility for maintaining approved standards for the home health agency.

“Located” means the physical address of the agency’s business office.

“Majority interest” means the largest percentage of ownership interest.

“Medication reminder” means a verbal prompt to the patient to take their medication. A medication reminder does not include the administration or any physical touching of the medication.

“Minority interest” means any percentage of ownership less than the majority interest.

“Modification of ownership and control (MOC)” means the sale, purchase, transfer or re-organization of ownership rights.

“Nurse” means an individual who is currently licensed to practice nursing pursuant to 24 Del.C. Ch. 19.

“Nutritional services” means those services defined pursuant to 24 Del.C. Ch. 38.

“Occupational therapist” means an individual who is currently licensed to practice occupational therapy pursuant to 24 Del.C. Ch. 20 and who offers the services to the public under any title incorporating the words "occupational therapy," "occupational therapist" or any similar title or description of occupational therapy services.

“Occupational therapist assistant” means an individual licensed to assist in the practice of occupational therapy pursuant to 24 Del.C. Ch. 20, under the supervision of an occupational therapist.

“Occupational therapy services” means those services defined pursuant to 24 Del.C. Ch. 20.

“Office” means the physical location in which the business of the home health agency is conducted and in which the records of personnel, contractors and patients of the agency are stored. The office shall be located in the State of Delaware.

“Owner” means an individual or legal entity with ownership rights of the agency.

“Ownership” means the state or fact of exclusive possession and control of the agency.

“Ownership interest” means the percentage of ownership an individual or legal entity possesses.

“Patient” means the individual receiving home health agency services as defined in this chapter.

“Patient record” means a written account of all services provided to a patient by the home health agency, as well as other pertinent information necessary to provide care.

“Personal care services” means the provision of services that do not require the judgment and skills of a licensed nurse or other professional. The services are limited to individual assistance with/or supervision of activities of daily living, companion services, transportation services, homemaker services, reporting changes in patient's condition and completing reports.

“Physical therapist” means an individual who is currently licensed to practice physical therapy pursuant to 24 Del.C. Ch. 26.

“Physical therapist assistant” means an individual who assists licensed physical therapists pursuant to 24 Del.C. Ch. 26.

“Physical therapy services” means those services defined pursuant to 24 Del.C. Ch. 26.

“Physician” means an individual currently licensed as such by 24 Del.C. Ch. 17.

“Plan of care” means a written plan that specifies scope, frequency and duration of services.

“Plan of correction” means a home health agency’s written response to findings of regulatory non-compliance. Plans must adhere to the format specified by the licensing agency, must include acceptable timeframes in which deficiencies will be corrected and must be approved by the licensing agency.

“Professional” means a person currently licensed in the State as an advance practice nurse, registered nurse, physician, physician assistant, physical therapist, occupational therapist, speech therapist, dentist, dietitian, social worker, respiratory care practitioner or psychologist.

“Professional therapy” means those services provided by a licensed professional in 1 of the following areas: physical therapy, occupational therapy, speech therapy, audiology or nutrition.

“Qualified professional” means an occupational therapist, a physical therapist, or a speech/language pathologist.

“Representative” means a person acting on behalf of the patient under Delaware law.

"Residence" means the domicile of the patient either personally owned by that patient or considered the place of residence of that patient where the home health care services will be provided.

“Serious injury” means physical injury that creates a substantial risk of death, or that causes serious disfigurement, serious impairment of health or serious loss or impairment of the function of any bodily organ.

“Service area” means the county in the state of Delaware in which the agency office is located and may also include the county or counties in the state of Delaware which are immediately adjacent.

“Skilled services” means those services provided directly by a licensed professional for the purpose of promoting, maintaining, or restoring the health of an individual or to minimize the effects of injury, illness or disability. Skilled services must be ordered by a physician or an allowable provider.

“Social services” means activity designed to promote social well-being. The services provided by the social worker depend on the needs of the patient. The social worker acts as an advocate to secure the patient's rights, directly counsels the patient and the patent's family, and refers the patient to other social agencies, community resources or facilities that can meet the patient's immediate and long-term needs.

“Social work assistant” means an individual with a baccalaureate degree in social work, psychology, sociology or other related field and has had at least 1 year of social work experience in a health care setting or has an associate degree in psychology, sociology or other related field and has had at least 2 years of social work experience in a health care setting. This individual works under the supervision of a social worker.

“Social worker” means an individual who has met the requirements of a graduate curriculum, leading to a master's degree, in a school of social work that is accredited by the council on Social Work Education.

“Speech/language pathologist” means an individual who is currently licensed pursuant to 24 Del.C. Ch. 37 and who offers the services to the public under any title or description of services incorporating the words "speech/language pathologist," "speech pathologist," "language pathologist," "speech and/or language therapist," "speech and/or language correctionist," "speech and/or language clinician," "voice therapist," "communicologist," "aphasiologist" or any other similar title or description of service.

“Speech pathology aide” means an individual who meets minimum qualifications pursuant to 24 Del.C. Ch. 37, which permit a speech pathology aide to assist speech/language pathologists in their professional endeavors, but only while under the direct supervision of a licensed speech/language pathologist.

“Speech therapy services” means those services defined pursuant to 24 Del.C. Ch. 37.

“Supervision of services” means authoritative procedural guidance by a qualified person for the accomplishment of a function or activity with initial direction and periodic inspection of the actual act of accomplishing the function or activity.

"Telehealth Mechanism" means the use of information exchange from 1 site to another via an electronic interactive telecommunication system. Telehealth is provided with specialized equipment at each site including real-time streaming via the use of video streaming and audio equipment. The telecommunications must permit real-time encryption of the interactive audio and video exchanges with the home health agency. The consumer must consent to the use of telehealth.

**History**
- *12 DE Reg. 1217 (03/01/09)*
- *18 DE Reg. 133 (08/01/14)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *27 DE Reg. 44 (07/01/23)*
- *12 DE Reg. 1217 (03/01/09)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *12 DE Reg. 1217 (03/01/09)*
- *15 DE Reg. 220 (08/01/11)*
- *19 DE Reg. 641 (01/01/16)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *27 DE Reg. 44 (07/01/23)*
- *12 DE Reg. 1217 (03/01/09)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *25 DE Reg. 773 (02/01/22)*
- *27 DE Reg. 44 (07/01/23)*
- *12 DE Reg. 1217 (03/01/09)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *12 DE Reg. 1217 (03/01/09)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *18 DE Reg. 133 (08/01/14)*
- *25 DE Reg. 527 (11/01/21)*
- *25 DE Reg. 773 (02/01/22)*
- *27 DE Reg. 44 (07/01/23)*

##### **16 Del. Admin. Code § 3350-2.0** Licensing Requirements and Procedures {#sec-3350-2.0 omnilex-key=us-de-regs-official--title-16--3350-2.0}

2.1 General Requirements

2.1.1 No person shall establish, conduct or maintain in this State any home health agency without first obtaining a license from the Department.

2.1.2 A separate license shall be required for each office maintained by a home health agency.

2.1.3 The home health agency shall advise the Department in writing at least 30 calendar days prior to any change in office location.

2.1.4 Any agency that undergoes a modification of ownership and control is required to re-apply as a new agency.

2.1.5 A license is not transferable from person to person or from entity to entity.

2.1.6 The license shall be posted in a conspicuous place on the licensed premises.

2.1.7 The agency shall only provide services in the service area. The agency may provide services to a patient during the patient’s time-limited travel outside the service area.

2.2 Application Process

2.2.1 All persons or entities applying for a license shall submit a written statement of intent to the Department describing the services to be offered by the agency and requesting a licensure application from the Department.

2.2.1.1 The issuance of an application form is in no way a guarantee that the completed application will be accepted or that a license will be issued by the Department.

2.2.1.2 No person or entity shall hold themselves out to the public as being a home health agency until a license has been issued by the Department.

2.2.2 In addition to a completed application for licensure, applicants shall submit to the Department the following information:

2.2.2.1 The names, addresses and types of agencies owned or managed by the applicant;

2.2.2.2 A copy of the applicant’s policies and procedures manual as requested by the Department;

2.2.2.3 Identity of:

2.2.2.3.1 Each officer and director of the corporation if the entity is organized as a corporation;

2.2.2.3.2 Each general partner or managing member if the entity is organized as an unincorporated entity;

2.2.2.3.3 The governing body;

2.2.2.3.4 Any officers/directors, partners, managing members or members of a governing body who have a financial interest of 5% or more in a licensee’s operation or related businesses;

2.2.2.4 Disclosure of any officer, director, partner, employee, managing member or member of the governing body with a felony criminal record;

2.2.2.5 Name of the individual (director) who is responsible for the management of the home health agency;

2.2.2.6 A list of management personnel, including credentials;

2.2.2.7 A plan for providing continuing education and training for agency personnel or contractors during the first year of operation; and

2.2.2.8 Any other information required by the Department.

2.3 Issuance of Licenses

2.3.1 Initial license

2.3.1.1 An initial license shall be granted for a period of 90 calendar days to every agency that completes the application process consistent with these regulations and whose policies and procedures demonstrate compliance with the rules and regulations pertaining to skilled home health agency licensure.

2.3.1.2 All home health agencies shall have an on-site survey during the first 90 calendar days of operation.

2.3.1.3 A home health agency, at the time of an initial on-site survey, must meet the definition of a home health agency as contained within these regulations and must be in operation and caring for patients. Agencies that, at the time of an on-site survey, do not meet the definition of a home health agency or that are not in substantial compliance with these regulations will not be granted a license.

2.3.1.4 An initial license will permit an agency to hire or contract with personnel and establish a patient caseload.

2.3.1.5 An initial license may not be renewed.

2.3.2 Provisional license

2.3.2.1 A provisional license may be granted for a period of less than 1 year to all home health agencies that:

2.3.2.1.1 Are not in substantial compliance with these rules and regulations; or

2.3.2.1.2 Fail to renew a license within the timeframe prescribed by these regulations.

2.3.2.2 The Department shall designate the conditions and the time period under which a provisional license is issued.

2.3.2.3 A provisional license may not be renewed unless a plan of correction for coming into substantial compliance with these rules and regulations has been approved by the Department and implemented by the home health agency.

2.3.2.4 A license will not be granted after the provisional licensure period to any agency that is not in substantial compliance with these rules and regulations.

2.3.3 Annual License

2.3.3.1 An annual license shall be granted for a period of 1 year (12 months) to all home health agencies which are in substantial compliance with these rules and regulations at the time of application.

2.3.3.2 An annual license shall be effective for a 12-month period following date of issue and shall expire 1 year following the issue date, unless it is: modified to a provisional, suspended or revoked, or surrendered prior to the expiration date.

2.3.3.3 Existing home health agencies must apply for renewal of licensure at least 30 calendar days prior to the expiration date of the license.

2.3.3.4 A license may not be issued to a home health agency:

2.3.3.4.1 Which does not meet the definition of a home health agency as contained within these regulations;

2.3.3.4.2 Which is not in substantial compliance with these regulations; or

2.3.3.4.3 Whose deficient practices present an immediate threat to the health and safety of its patients.

2.4 Disciplinary proceedings

2.4.1 The Department may impose sanctions (subsection 2.4.2 of this regulation) singly or in combination when it finds a licensee or former licensee has:

2.4.1.1 Violated any of these regulations;

2.4.1.2 Failed to submit a reasonable timetable for correction of deficiencies;

2.4.1.3 Exhibited a pattern of cyclical deficiencies which extends over a period of 2 or more years;

2.4.1.4 Failed to correct deficiencies in accordance with a timetable submitted by the applicant and agreed upon by the Department;

2.4.1.5 Engaged in any conduct or practices detrimental to the welfare of the patients;

2.4.1.6 Exhibited incompetence, negligence or misconduct in operating the home health agency or in providing services to individuals;

2.4.1.7 Mistreated or abused individuals cared for by the home health agency;

2.4.1.8 Violated any statutes relating to Medical Assistance or Medicare reimbursement for those agencies who participate in those programs; or

2.4.1.9 Refused to allow the Department access to the agency or records for the purpose of conducting inspections/surveys/investigations as deemed necessary by the Department.

2.4.2 Disciplinary sanctions may include:

2.4.2.1 Permanently revoke a license.

2.4.2.2 Suspend a license.

2.4.2.3 Issue a letter of reprimand.

2.4.2.4 Place a licensee on provisional status and require the licensee to:

2.4.2.4.1 Report regularly to the Department upon the matters which are the basis of the provisional status;

2.4.2.4.2 Limit practice to those areas prescribed by the Department; and

2.4.2.4.3 Suspend new intakes and admissions.

2.4.2.5 Refuse a license.

2.4.2.6 Refuse to renew a license.

2.4.2.7 The Department may request the Superior Court to impose a civil penalty of not more than $10,000 for a violation of these regulations. Each day a violation continues constitutes a separate violation.

2.4.2.7.1 In lieu of seeking a civil penalty, the Department, in its discretion, may impose an administrative penalty of not more than $10,000 for a violation of these regulations. Each day a violation continues constitutes a separate violation.

2.4.2.7.2 In determining the amount of any civil or administrative penalty imposed, the Court or the Department shall consider the following factors:

2.4.2.7.2.1 The seriousness of the violation, including the nature, circumstances, extent and gravity of the violation and the threat or potential threat to the health or safety of any patient;

2.4.2.7.2.2 The history of violations committed by the person or the person's affiliate(s), agents, employee(s) or controlling person(s);

2.4.2.7.2.3 The efforts made by the agency to correct the violation(s);

2.4.2.7.2.4 Any misrepresentation made to the Department; and

2.4.2.7.2.5 Any other matter that affects the health, safety or welfare of a patient(s).

2.4.2.8 Otherwise discipline.

2.4.3 Imposition of Disciplinary Action

2.4.3.1 Before any disciplinary action is taken (except as authorized by subsection 2.4.4):

2.4.3.1.1 The Department shall give 20 calendar days written notice to the holder of the license, setting forth the reasons for the determination.

2.4.3.1.2 The disciplinary action shall become final 20 calendar days after the mailing of the notice unless the licensee, within such 20 calendar day period, shall give written notice of the agency’s desire for a hearing.

2.4.3.1.3 If the licensee gives such notice, the agency shall be given a hearing before the Secretary of the Department or her/his designee and may present such evidence as may be proper.

2.4.3.1.4 The Secretary of the Department or her/his designee shall make a determination based upon the evidence presented.

2.4.3.1.5 A written copy of the determination and the reasons upon which it is based shall be sent to the agency.

2.4.3.1.6 The decision shall become final 20 calendar days after the mailing of the determination letter unless the licensee, within the 20 calendar day period, appeals the decision to the appropriate court of the State.

2.4.4 Order to immediately suspend a license

2.4.4.1 In the event the Department identifies activities which the Department determines present an immediate jeopardy or imminent danger to the public health, welfare and safety requiring emergency action, the Department may issue an order temporarily suspending the licensee's license, pending a final hearing on the complaint. No order temporarily suspending a license shall be issued by the Department, with less than 24 hours prior written or oral notice to the licensee or the licensee's attorney so that the licensee may be heard in opposition to the proposed suspension. An order of temporary suspension under this section shall remain in effect for a period not longer than 60 calendar days from the date of the issuance of said order, unless the suspended licensee requests a continuance of the date for the final hearing before the Department. If a continuance is requested, the order of temporary suspension shall remain in effect until the Department has rendered a decision after the final hearing.

2.4.4.2 The licensee, whose license has been temporarily suspended, shall be notified forthwith in writing. Notification shall consist of a copy of the deficiency report and the order of temporary suspension pending a hearing and shall be personally served upon the licensee or sent by mail, return receipt requested, to the licensee's last known address.

2.4.4.3 A licensee whose license has been temporarily suspended pursuant to this section may request an expedited hearing. The Department shall schedule the hearing on an expedited basis provided that the Department receives the licensee's written request for an expedited hearing within 5 calendar days from the date on which the licensee received notification of the Department's decision to temporarily suspend the licensee's license.

2.4.4.4 As soon as possible, but in no event later than 60 calendar days after the issuance of the order of temporary suspension, the Department shall convene for a hearing on the reasons for suspension. In the event that a licensee, in a timely manner, requests an expedited hearing, the Department shall convene within 15 calendar days of the receipt by the Department of such a request and shall render a decision within 30 calendar days.

2.4.4.5 In no event shall an order of temporary suspension remain in effect for longer than 60 calendar days unless the suspended licensee requests an extension of the order of temporary suspension pending a final decision of the Department. Upon a final decision of the Department, the order of temporary suspension may be vacated in favor of the disciplinary action ordered by the Department.

2.4.5 Termination of license

2.4.5.1 Termination of a license to provide services as a home health agency occurs secondary to:

2.4.5.1.1 Revocation of a license or the voluntary surrender of a license in avoidance of revocation action.

2.4.5.2 Termination of rights to provide services extends to:

2.4.5.2.1 Agency;

2.4.5.2.2 Owner(s);

2.4.5.2.3 Officers/Directors, partners, managing members or members of a governing body who have a financial interest of 5% or more in the home health agency; and

2.4.5.2.4 Corporation officers.

2.5 Modification of Ownership and Control (MOC)

2.5.1 Any proposed MOC must be reported to the Department a minimum of 30 calendar days prior to the change.

2.5.2 A MOC voids the current license in possession of the agency.

2.5.3 A MOC may include but is not limited to:

2.5.3.1 Transfer of full ownership rights;

2.5.3.2 Transfer of the majority interest;

2.5.3.3 Transfer of ownership interests that result in the owner with the majority interest becoming a minority interest owner;

2.5.3.4 Transfer or re-organization that results in an additional majority interest that is equal in ownership rights; or

2.5.3.5 Transfer resulting in a measurable impact upon the operational control of the agency.

2.6 Fees. Fees shall be in accordance with 16 Del.C. §122(3)o.

2.7 Inspection. A representative of the Department shall periodically inspect every home health agency for which a license has been issued under this chapter. Inspections by authorized representatives of the Department may occur at any time and may be scheduled or unannounced.

2.8 Notice to Patients. The home health agency shall notify each patient or the patient's authorized representative, the patient's attending physician or allowable provider (as appropriate), and any third-party payers at least 30 calendar days before the voluntary surrender of its license, or as directed under an order of denial, revocation or suspension of license issued by the Department.

2.9 Exclusions from Licensure. The following persons, associations or organizations are not required to obtain a home health agency license:

2.9.1 Those individuals who contract directly with a patient to provide services for that patient, where the patient pays the individual for services rendered and neither the patient nor the individual pays an agency on a periodic basis.

2.9.2 Those agencies that provide only durable medical equipment and supplies for in-home use.

2.9.3 Those agencies that provide staff to licensed home health agencies, such as temporary employment/staffing agencies, provided that:

2.9.3.1 Temporary employment/staffing agencies may not provide services under direct agreements with patients.

2.9.3.2 Temporary employment/staffing agencies must be contractually bound to perform services under the contracting providers’ direction and supervision.

2.9.3.3 Temporary staff working for a licensed provider must meet the requirements of these regulations.

2.9.4 Any visiting nurse service or home health services conducted by and for those who rely upon spiritual means through prayer alone for healing in accordance with the tenets and practices of a registered church or religious denomination.

2.9.5 An agency which solely provides services as defined in 16 Del.C. Ch. 94, the Community Based Attendant Services Act.

2.9.6 A Personal Assistance Services Agency which solely provides services defined in 16 Del.C. §122(3)x.

**History**
- *12 DE Reg. 1217 (03/01/09)*
- *18 DE Reg. 133 (08/01/14)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *27 DE Reg. 44 (07/01/23)*
- *12 DE Reg. 1217 (03/01/09)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *12 DE Reg. 1217 (03/01/09)*
- *15 DE Reg. 220 (08/01/11)*
- *19 DE Reg. 641 (01/01/16)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *27 DE Reg. 44 (07/01/23)*
- *12 DE Reg. 1217 (03/01/09)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *25 DE Reg. 773 (02/01/22)*
- *27 DE Reg. 44 (07/01/23)*
- *12 DE Reg. 1217 (03/01/09)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *12 DE Reg. 1217 (03/01/09)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *18 DE Reg. 133 (08/01/14)*
- *25 DE Reg. 527 (11/01/21)*
- *25 DE Reg. 773 (02/01/22)*
- *27 DE Reg. 44 (07/01/23)*

##### **16 Del. Admin. Code § 3350-3.0** General Requirements {#sec-3350-3.0 omnilex-key=us-de-regs-official--title-16--3350-3.0}

3.1 All records maintained by the home health agency shall at all times be open to inspection by the authorized representatives of the Department.

3.2 No policies shall be adopted by the home health agency which are in conflict with these regulations.

3.3 Reports of incidents, accidents and medical emergencies shall be kept on file at the agency for a minimum of six years.

3.4 The home health agency shall advise the Department in writing within 30 calendar days following any change in the designation of the director or clinical director within the agency.

3.5 The home health agency may contract for services to be provided to its patients. Individuals providing services under contract must meet the same requirements as those persons employed directly by the agency.

3.6 The director or clinical director shall be available at all times during the operating hours of the home health agency.

3.7 The home health agency shall advise the Department in writing at least 30 calendar days prior to any change in office location.

3.8 The home health agency must permit photocopying of any records or other information by, or on behalf of authorized representatives of the Department, as necessary to determine or verify compliance with these regulations.

3.9 The agency shall have policies and an operational system which assure uninterrupted implementation of the plan of care. In furtherance of this requirement, the agency shall, at a minimum: 1) maintain a sufficient pool of qualified employees/contractors to fulfill plans of care and provide scheduled services; and 2) develop and maintain a back-up system to provide substitute employees/contractors if regularly scheduled employees/contractors are unavailable.

3.10 The agency shall be in compliance with federal, state and local laws and codes.

3.11 Prior to the provision of services in a health care facility, the home health agency must obtain written permission from each health care facility in which services will be provided.

**History**
- *12 DE Reg. 1217 (03/01/09)*
- *18 DE Reg. 133 (08/01/14)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *27 DE Reg. 44 (07/01/23)*
- *12 DE Reg. 1217 (03/01/09)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *12 DE Reg. 1217 (03/01/09)*
- *15 DE Reg. 220 (08/01/11)*
- *19 DE Reg. 641 (01/01/16)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *27 DE Reg. 44 (07/01/23)*
- *12 DE Reg. 1217 (03/01/09)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *25 DE Reg. 773 (02/01/22)*
- *27 DE Reg. 44 (07/01/23)*
- *12 DE Reg. 1217 (03/01/09)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *12 DE Reg. 1217 (03/01/09)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *18 DE Reg. 133 (08/01/14)*
- *25 DE Reg. 527 (11/01/21)*
- *25 DE Reg. 773 (02/01/22)*
- *27 DE Reg. 44 (07/01/23)*

##### **16 Del. Admin. Code § 3350-4.0** Governing Body {#sec-3350-4.0 omnilex-key=us-de-regs-official--title-16--3350-4.0}

4.1 Each home health agency shall have an organized governing body (governing authority, owner or person(s) designated by the owner).

4.2 The governing body shall be ultimately responsible for:

4.2.1 The management and control of the agency;

4.2.2 The assurance of quality care and services;

4.2.3 Compliance with all federal, state and local laws and regulations;

4.2.4 Adoption of written policies and procedures which describe the functions and services of the agency;

4.2.5 Providing a sufficient number of appropriately qualified personnel;

4.2.6 Providing physical resources and equipment, supplies and services for the provision of safe, effective and efficient delivery of care services;

4.2.7 Developing an organizational structure establishing lines of authority and responsibility;

4.2.8 Appointing a qualified director;

4.2.9 Appointing members of the clinical staff, ensuring their competence and delineating their clinical privileges;

4.2.10 Conducting meetings, when the governing body is more than 1 person, at least annually and maintaining written minutes of the meeting(s);

4.2.11 Annual review and evaluation of the agency policies and services; and

4.2.12 Other relevant health and safety requirements.

4.3 There shall be a description of each type of service offered.

4.4 There shall be written policies and procedures pertaining to each service offered.

4.5 There shall be a description of the system for the maintenance of patient records.

4.6 Bylaws shall be reviewed annually by the governing body and so dated. Revisions shall be completed as necessary.

**History**
- *12 DE Reg. 1217 (03/01/09)*
- *18 DE Reg. 133 (08/01/14)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *27 DE Reg. 44 (07/01/23)*
- *12 DE Reg. 1217 (03/01/09)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *12 DE Reg. 1217 (03/01/09)*
- *15 DE Reg. 220 (08/01/11)*
- *19 DE Reg. 641 (01/01/16)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *27 DE Reg. 44 (07/01/23)*
- *12 DE Reg. 1217 (03/01/09)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *25 DE Reg. 773 (02/01/22)*
- *27 DE Reg. 44 (07/01/23)*
- *12 DE Reg. 1217 (03/01/09)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *12 DE Reg. 1217 (03/01/09)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *18 DE Reg. 133 (08/01/14)*
- *25 DE Reg. 527 (11/01/21)*
- *25 DE Reg. 773 (02/01/22)*
- *27 DE Reg. 44 (07/01/23)*

##### **16 Del. Admin. Code § 3350-5.0** Administration/Personnel {#sec-3350-5.0 omnilex-key=us-de-regs-official--title-16--3350-5.0}

5.1 Director

5.1.1 There shall be a full-time agency director.

5.1.2 The director shall have the overall authority and responsibility for the daily operation and management of the agency.

5.1.3 The authority, duties and responsibilities of the director shall be defined in writing and shall include but not be limited to:

5.1.3.1 Interpretation and execution of the policies adopted by the governing body;

5.1.3.2 Program planning, budgeting, management and program evaluation;

5.1.3.3 Maintenance of the agency’s compliance with licensure regulations and standards;

5.1.3.4 Preparation and submission of required reports;

5.1.3.5 Distribution of a written plan for the delegation of administrative responsibilities and functions in the absence of the director;

5.1.3.6 Documentation of complaints and grievances relating to the conduct or actions by employees/contractors and action taken secondary to the complaints or grievances; and

5.1.3.7 Conducting or supervising the resolution of complaints and grievances received from patients in the delivery of care or services by the agency.

5.1.3.8 Reviewing policies and procedures at least annually and reporting, in writing, to the governing body on the review.

5.1.4 The director shall designate, in writing, a similarly qualified person to act in the absence of the director.

5.2 Supervision of Clinical Services

5.2.1 The director shall appoint a full-time employee as the clinical director.

5.2.2 The clinical director shall be responsible for implementing, coordinating and assuring quality of patient care services.

5.2.3 The clinical director shall:

5.2.3.1 Be a registered nurse with at least 1 year of home health and administrative/supervisory experience;

5.2.3.2 Be available at all times during operating hours of the home health agency;

5.2.3.3 Participate in all activities related to the services provided, including the qualifications of personnel and contractors as related to their assigned duties; and

5.2.3.4 Provide general supervision and direction of the services offered by the home health agency.

5.2.4 In the absence of the clinical director, an equally qualified designee must be appointed.

5.3 Contract Services

5.3.1 The home health agency maintains responsibility for all services provided to the patient.

5.3.2 Services provided by the home health agency through arrangements with a contractor agency or individual shall be set forth in a written contract which clearly specifies:

5.3.2.1 That the patient’s contract for care is with the home health agency;

5.3.2.2 The services to be provided by the contractor;

5.3.2.3 The necessity to conform to all home health agency policies;

5.3.2.4 The procedure for submitting clinical and progress notes, scheduling visits, periodic patient evaluation, and determining charges and reimbursement;

5.3.2.5 The procedure for annual assurance of clinical competence of all individuals utilized under contract;

5.3.2.6 The procedure for supervision of services of the contracted individuals;

5.3.2.7 That all payments by the patient for services rendered shall be made directly to the agency or its billing representative and no payments shall be made to or in the name of contractors of the agency;

5.3.2.8 That patients are accepted only by the home health agency. Patients may not be admitted for services by a contracted individual without prior review of the case and acceptance of the patient by the home health agency in accordance with agency policies; and

5.3.2.9 That the written contractual arrangement must contain a renewal clause or be renewed annually.

5.3.3 The agency must ensure that personnel and services contracted meet the requirements specified in these regulations for home health agency personnel and services.

5.4 Written Policies

5.4.1 Policy manuals shall be prepared and followed which outline the procedures and practices of the agency.

5.4.2 The home health agency shall establish written policies regarding:

5.4.2.1 The rights and responsibilities of patients;

5.4.2.2 The handling and documentation of incidents, accidents and medical emergencies;

5.4.2.2.1 Reports of these events shall be kept on file at the agency.

5.4.2.3 Control of the exposure of patients and staff to persons with communicable diseases;

5.4.2.4 Reporting of all reportable communicable diseases to the Department;

5.4.2.5 The patient’s (and family or representative, if any) right to have concerns addressed without fear of reprisal. This policy must include the mechanism for informing the patient of her/his right to report concerns/complaints to the Department at a telephone number established for that purpose.

5.4.2.6 The procedure to be followed in the event that the home health agency is not able to provide services scheduled for any particular day or time. This policy shall include at a minimum:

5.4.2.6.1 The procedure for contacting the patient prior to the missed visit;

5.4.2.6.2 The procedure for attempts to find a substitute caregiver; and

5.4.2.6.3 Documentation of the missed visit and patient contact.

5.4.2.7 Infection control.

5.4.2.8 Employment/Personnel which shall include:

5.4.2.8.1 Qualifications, responsibilities and requirements for each job classification;

5.4.2.8.2 Pre-employment requirements;

5.4.2.8.3 Position descriptions;

5.4.2.8.4 Orientation policy and procedure for all employees and contractors;

5.4.2.8.5 Inservice education policy;

5.4.2.8.6 Annual performance review and competency testing; and

5.4.2.8.7 The process of appointment to the professional staff whereby it can satisfactorily be determined that the individual is appropriately licensed and qualified for the privileges and responsibilities to be given.

5.4.2.9 Referrals received, admission of patients to agency services, delivery of those services and discharge of patients.

5.4.2.10 The use and removal of records and the conditions for release of information in accordance with statutory provisions pertaining to confidentiality.

5.4.3 The home health agency shall review its written policies at least annually, and revise them as necessary.

5.4.4 Policies shall be made available to representatives of the Department upon request.

5.5 Personnel Records

5.5.1 Records of each employee/contractor shall be kept current and available upon request by authorized representatives of the Department.

5.5.2 For individuals utilized via contract with another agency, the home health agency shall obtain, upon request, any records as required by the Department.

5.5.3 For all individuals, the agency shall maintain individual personnel records which shall contain at least:

5.5.3.1 Written verification of compliance with pre-employment requirements;

5.5.3.2 Documentation of clinical competence;

5.5.3.3 Evidence of current professional licensure, registration or certification as appropriate;

5.5.3.4 Educational preparation and work history;

5.5.3.5 Written performance evaluations (annually); and

5.5.3.6 A written and signed job description.

5.6 Health History

5.6.1 All new employees/contractors shall be required to have a physical examination prior to providing care:

5.6.1.1 The physical examination must have been completed within 12 months prior to employment/referral and

5.6.1.2 A copy of the physical examination shall be maintained in individual files.

5.6.2 Minimum requirements for tuberculosis (TB) testing are those currently recommended by the Centers for Disease Control and Prevention of the U.S. Department of Health and Human Services:

5.6.2.1 A baseline testing must be completed upon hire and, thereafter, as determined by a TB risk assessment.

5.6.2.2 No person found to have active TB in an infectious stage shall be permitted to give care or service to patients.

5.6.2.3 Any person having a positive skin test but a negative chest X-ray must complete a statement annually attesting that they have experienced no symptoms which may indicate active TB infection.

5.6.2.4 A report of all TB test results and all attestation statements shall be on file at the home health agency.

5.6.3 Any individual who cannot adequately perform the duties required or who may jeopardize the health or safety of the patient or patients shall be relieved of their duties and removed from the agency until such time as the condition is resolved. This includes infections of a temporary nature.

5.7 Staff Development

5.7.1 Staff development must be supervised by a registered nurse with at least 1 year of home health and administrative/supervisory experience.

5.7.2 All employees/contractors are required to complete an orientation program.

5.7.3 An orientation/training program should be based on an instruction plan that includes learning objectives, clinical content and minimum acceptable performance standards. and shall include but not be limited to:

5.7.3.1 Organizational structure of the agency;

5.7.3.2 Agency patient care policies and procedures;

5.7.3.3 Philosophy of patient care;

5.7.3.4 Description of patient population and geographic location served;

5.7.3.5 Patient rights;

5.7.3.6 Agency personnel and administrative policies;

5.7.3.7 Job description;

5.7.3.8 Disaster Preparedness; and

5.7.3.9 Applicable state regulations governing the delivery of home health care services.

5.7.4 All newly hired/contracted aides shall be required to complete or show evidence of having completed a minimum of 75 hours of training which shall include instruction and supervised practicum and which addresses:

5.7.4.1 Personal care services;

5.7.4.2 Principles of good nutrition;

5.7.4.3 Process of growth, development and aging;

5.7.4.4 Principles of infection control;

5.7.4.5 Observation, reporting and documentation of patient status;

5.7.4.6 Maintaining a clean, safe and healthy environment;

5.7.4.7 Maintaining a least restrictive environment;

5.7.4.8 Verbal/non-verbal communication skills;

5.7.4.9 Reading and recording temperature, pulse and respiration;

5.7.4.10 Safe transfer techniques and ambulation;

5.7.4.11 Normal range of motion and positioning;

5.7.4.12 Principles of body mechanics; and

5.7.4.13 The needs of the elderly and persons with disabilities.

5.7.5 Aides who experience a break in service for greater than 2 calendar years will be required to:

5.7.5.1 Repeat the minimum of 75 hour training requirement; or

5.7.5.2 Successfully demonstrate competence in each of the required training areas.

5.7.6 Ongoing staff development is required to maintain and improve the skills of the caregiver. Aides shall attend at least 12 hours annually of staff development activities which shall consist of in-service training programs, workshops, or conferences related to home health care or specific needs of patients and which shall include but not be limited to:

5.7.7 Documentation of orientation and continuing education must include the dates and hours, content, and name and title of the person providing the orientation/education.

5.7.8 It is the responsibility of the home health agency to ensure that employees/contractors are proficient to carry out the care assigned in a safe, effective and efficient manner.

5.7.9 All employees and contractors must pass a competency evaluation test prior to providing care to patients and annually thereafter.

5.7.10 The time allotted for training shall be sufficient to foster safe and skillful services to the patient.

5.7.11 Attendance records must be kept for all orientation and continuing education programs.

5.7.12 All employees/contractors providing direct patient care must complete annual demential-specific training that includes: communicating with persons diagnosed as having Alzheimer's disease or other forms of dementia; the psychological, social, and physical needs of those persons; and safety measures which need to be taken with those persons.

**History**
- *12 DE Reg. 1217 (03/01/09)*
- *18 DE Reg. 133 (08/01/14)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *27 DE Reg. 44 (07/01/23)*
- *12 DE Reg. 1217 (03/01/09)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *12 DE Reg. 1217 (03/01/09)*
- *15 DE Reg. 220 (08/01/11)*
- *19 DE Reg. 641 (01/01/16)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *27 DE Reg. 44 (07/01/23)*
- *12 DE Reg. 1217 (03/01/09)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *25 DE Reg. 773 (02/01/22)*
- *27 DE Reg. 44 (07/01/23)*
- *12 DE Reg. 1217 (03/01/09)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *12 DE Reg. 1217 (03/01/09)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *18 DE Reg. 133 (08/01/14)*
- *25 DE Reg. 527 (11/01/21)*
- *25 DE Reg. 773 (02/01/22)*
- *27 DE Reg. 44 (07/01/23)*

##### **16 Del. Admin. Code § 3350-6.0** Patient Care Management {#sec-3350-6.0 omnilex-key=us-de-regs-official--title-16--3350-6.0}

6.1 Admission

6.1.1 The admission policies shall be discussed with each patient entering the program or their representative, if applicable.

6.1.2 The home health agency shall only admit those individuals whose needs can be met by the agency.

6.1.3 There shall be a written agreement between the patient and the home health agency. The agreement shall:

6.1.3.1 Specify the services to be provided by the agency, including but not limited to: frequency of visits including hours per day or week and days per week, transportation agreements as appropriate, emergency procedures and conditions for discharge and appeal.

6.1.3.2 Specify the procedure to be followed when the agency is not able to keep a scheduled patient visit.

6.1.3.3 Specify financial arrangements which shall minimally include:

6.1.3.3.1 A description of services purchased and the associated cost;

6.1.3.3.2 An acceptable method of payment(s) for these services;

6.1.3.3.3 An outline of the billing procedures; and

6.1.3.3.4 That all payments by the patient for services rendered shall be made directly to the agency or its billing representative and no payments shall be made to or in the name of individual employees/contractors of the agency.

6.1.3.4 Be signed by the patient, if (s)he is able, or representative, if any, and the representative of the home health agency.

6.1.3.5 Be given to the patient or representative, if any, and a copy shall be kept at the agency in the patient record.

6.1.3.6 Be reviewed and updated as necessary to reflect any change in the services or the financial arrangements.

6.2 Assessment

6.2.1 An initial assessment of the patient must be performed by a registered nurse or qualified professional and must be completed:

6.2.1.1 Within 48 hours of referral if patient is currently in their residence; or

6.2.1.2 Within 48 hours of discharge from a health care facility; or

6.2.1.3 On the physician or allowable provider ordered start of care date.

6.2.2 Prior to the provision of services, at a minimum, the initial assessment must include evidence of the following:

6.2.2.1 Physical condition, including ability to perform activities of daily living and sensory limitations;

6.2.2.2 Social situation, including living arrangements and the availability of family and community support;

6.2.2.3 Mental status, including any cognitive impairment and known psychiatric, emotional, and behavioral problems; and

6.2.2.4 Current medication regimen.

6.2.2.5 A visit to the patient’s residence to determine whether the agency has the ability to provide the necessary services in a safe manner.

6.2.3 Reassessments must include, at a minimum, a description of the patient’s:

6.2.3.1 Physical condition, including ability to perform activities of daily living and sensory limitations;

6.2.3.2 Social situation, including living arrangements and the availability of family and community support;

6.2.3.3 Mental status, including any cognitive impairment and known psychiatric, emotional, and behavioral problems; and

6.2.3.4 Current medication regimen.

6.2.4 Patient reassessments and monitoring must occur at regular intervals based upon the patient’s condition and needs, but no less often than every 60 calendar days. A registered nurse, or a qualified professional of the appropriate discipline, must participate in the reassessment and monitoring of the patient.

6.2.4.1 Every other patient reassessment must be completed in person.

6.2.4.2 Patient reassessments not completed in person must be completed by a telehealth mechanism.

6.2.5 A reassessment shall be conducted when the needs of the patient change which indicate a revision to the plan of care is needed.

6.2.6 The initial assessment and reassessments shall become a permanent part of the patient’s record.

6.3 Plan of Care

6.3.1 The home health agency must provide services in accordance with an individualized written plan of care:

6.3.1.1 The individualized written plan of care for patients receiving skilled services must be established by the physician or allowable provider and developed in consultation with a registered nurse or qualified professional of the appropriate discipline and the patient/patient representative (if the patient/patient representative chooses).

6.3.1.2 The written plan of care for patients receiving aide only services must be established and developed by the registered nurse or qualified professional of the appropriate discipline and the patient/patient representative (if the patient/patient representative chooses).

6.3.2 A plan of care is developed on admission based upon the initial assessment of the patient.

6.3.3 The plan of care shall include reference to at least the following:

6.3.3.1 Pertinent diagnoses;

6.3.3.2 Prognosis, including short-term and long-term objectives of treatment;

6.3.3.3 Types of services (such as nursing, other therapeutic, or support services), frequency and duration of services to be provided, medications, diet, treatments, procedures, equipment and transportation required;

6.3.3.4 Functional limitations of the patient;

6.3.3.5 Activities permitted; and

6.3.3.6 Safety measures required to protect the patient from injury;

6.3.4 The plan of care must be reviewed as often as the severity of the patient’s condition requires, but at least every 60 calendar days.

6.3.4.1 The plan of care for patients receiving skilled services must be reviewed by the physician or allowable provider and with a registered nurse or qualified professional of the appropriate discipline.

6.3.4.2 The plan of care for patients receiving aide only services must be reviewed by the registered nurse or qualified professional of the appropriate discipline.

6.3.5 The home health agency must have policies and procedures describing the method to obtain and incorporate the physician or allowable provider’s orders into the plan of care.

6.3.6 The home health agency shall promptly alert the attending physician or allowable provider to any changes in the patient’s condition that suggest a need to alter the plan of care.

6.3.7 The home health agency shall consider benefits versus risks of treatment as well as patient choice and independence in the development and subsequent revisions of the plan of care.

6.4 Home Health Aide Care Plan

6.4.1 The home health agency must develop a written home health aide care plan for each patient receiving home health aide services.

6.4.2 A copy of the home health aide care plan is kept at the patient’s residence.

6.4.3 The written home health aide care plan must be established by a registered nurse or qualified professional of the appropriate discipline.

6.4.4 A home health aide care plan is developed on admission based upon the initial assessment of the patient.

6.4.5 The home health aide care plan must be reviewed by a registered nurse or other qualified professional of the appropriate discipline as often as the severity of the patient’s condition requires, but at least every 60 calendar days.

6.5 Medication and Treatment Management

6.5.1 Medication shall not be administered to a patient unless prescribed by a licensed practitioner with independent prescriptive authority as provided by Delaware Code.

6.5.2 All medication administered to patients by the home health agency shall be ordered in writing, dated and signed by the prescribing licensed practitioner.

6.5.3 All prescription medications shall be properly labeled.

6.5.4 Appropriately licensed individuals must immediately record, sign, and date verbal orders for medications and treatments. The signature of the licensed practitioner ordering the medications or treatments must be obtained as soon as possible.

6.5.5 Medications and treatments may be self-administered or, when administered by the home health agency, shall be administered in accordance with all State and Federal laws, including the State of Delaware Board of Professional Regulation’s requirements. Those patients who, upon admission, are incapable of self-administration or who become incapable of self-administration shall have their medications/treatments administered according to the requirements of the Board of Professional Regulation, when the medications/treatments are administered by the home health agency.

6.5.6 The home health agency shall maintain a record of all medication and treatments administered to a patient indicating date, time of day, type of medication/treatment, dose, route of self-administration/administration, by whom given and any reactions noted.

6.6 Patient Services

6.6.1 Nursing

6.6.1.1 Services are provided by registered and licensed practical nurses.

6.6.1.2 The home health agency must maintain verification of current licensure as required by the Delaware Board of Nursing.

6.6.1.3 Services must be provided in accordance with the written plan of care and acceptable standards of practice.

6.6.1.4 Services are provided under the supervision and direction of the clinical director.

6.6.2 Professional Therapy

6.6.2.1 Services are provided by, or under the supervision of, the appropriate professional therapist (physical therapy, occupational therapy, speech therapy, audiology, nutrition).

6.6.2.2 The home health agency must maintain verification of current licensure/registration as required by the Delaware Division of Professional Regulation.

6.6.2.3 Services must be provided in accordance with the written plan of care and acceptable standards of practice.

6.6.2.4 Services are provided under the supervision and direction of the clinical director.

6.6.3 Social Services. Social services, when provided, are given by a qualified social worker and in accordance with the written plan of care.

6.6.4 Home Health Aide

6.6.4.1 Services are provided under the supervision and direction of the clinical director or the appropriate qualified professional.

6.6.4.2 On-site professional supervisory visits are required for all patients receiving home health aide services.

6.6.4.2.1 When patients are receiving home health aide services as well as another skilled service, a registered nurse (or another professional therapist if the patient is not receiving nursing services) must make an on-site supervisory visit to the patient’s residence no less frequently than every 2 weeks.

6.6.4.2.2 When home health aide services are being provided in the absence of a skilled service, a registered nurse must make an on-site supervisory visit to the patient’s residence (while the home health aide is providing care) no less frequently than every 60 calendar days.

6.6.4.2.3 Every other supervisory visit must be completed in person.

6.6.4.2.4 Supervisory visits not completed in person must be completed by a telehealth mechanism.

6.6.4.3 Services must be provided in accordance with a written home health aide care plan.

6.6.5 A home health agency is responsible for coordination of services to assure that the services effectively complement 1 another and support the objective(s) outlined in the plan of care.

6.6.6 Competent patients who do not reside in a medical facility or a facility regulated pursuant to 16 Del.C. Ch. 11 may delegate personal care services to home health aides provided:

6.6.6.1 The nature of the service/task is not excluded by law or other state or federal regulation;

6.6.6.2 The services/tasks are those competent patients could normally perform themselves but for functional limitation; and

6.6.6.3 The delegation decision is entirely voluntary.

6.6.7 Services provided to patients who are not able to delegate services/tasks due to impaired cognitive function shall be those delegated by the registered nurse as permitted by law.

6.7 Records and Reports

6.7.1 There shall be a separate record maintained at the home health agency for each patient which shall contain:

6.7.1.1 Admission record including:

6.7.1.1.1 Name;

6.7.1.1.2 Birth date;

6.7.1.1.3 Home address;

6.7.1.1.4 Telephone number;

6.7.1.1.5 Identification number(s) (i.e. Social Security, Medicaid, Medicare);

6.7.1.1.6 Date of admission;

6.7.1.1.7 Physician or allowable provider’s name, address and telephone number; and

6.7.1.1.8 Names, addresses and telephone numbers of family members, friends or other designated people to be contacted in the event of illness or an emergency.

6.7.1.2 Referral Form and Request for Services Form.

6.7.1.3 Assessment (initial and reassessments).

6.7.1.4 Individual plan of care (initial, reviews and revisions).

6.7.1.5 Home health aide care plan.

6.7.1.6 Progress notes, chronological and timely.

6.7.1.7 Advance health-care directive form that complies with 16 Del.C. Ch. 25, a statement that a copy of the advance health-care directive form has been requested, or a statement that none has been signed.

6.7.1.8 A copy of the written agreement between the patient and the home health agency including any updates made to the original reflecting changes in services or arrangements.

6.7.1.9 Written acknowledgment that the patient or the patient’s representative has been fully informed of the patient’s rights.

6.7.1.10 Medication orders.

6.7.1.11 Nutrition orders.

6.7.1.12 Treatment orders.

6.7.1.13 Activity orders.

6.7.1.14 Copies of any summary reports requested by the physician or allowable provider.

6.7.1.15 A discharge summary.

6.7.2 Aide notes must contain the following information:

6.7.2.1 Date(s) on which service(s) are provided;

6.7.2.2 Hour(s) of service(s) provided;

6.7.2.3 Type(s) of service(s) provided; and

6.7.2.4 Observations/problems/comments.

6.7.3 All notes written in the patient’s record must be signed and dated or authenticated by the employee/contractor on the day that the service is rendered.

6.7.4 All notes and reports in the patient’s record shall be electronic or legibly written in ink, dated and signed by the recording person with her/his full name and title.

6.7.5 All notes must be incorporated into the patient’s record no less often than every 30 days.

6.7.6 All patients’ records shall be maintained in accordance with professional standards.

6.7.7 All patient records shall be available for review by authorized representatives of the Department and to legally authorized persons; otherwise patient records shall be held confidential. The consent of the patient or her/his representative, if the patient is incapable of making decisions, shall be obtained before any personal information is released from her/his records as authorized by these regulations or Delaware law.

6.7.8 Computerized patient records must be printed by the agency as requested by authorized representatives of the Department.

6.7.9 The home health agency records shall be retained in a retrievable form until destroyed.

6.7.9.1 Records of adults (18 years of age and older) shall be retained for a minimum of 6 years after the last date of service before being destroyed.

6.7.9.2 Records of minors (less than 18 years of age) shall be retained for a minimum of 6 years after the patient reaches 18 years of age.

6.7.9.3 All records must be disposed of by shredding, burning, or other similar protective measure in order to preserve the patients’ rights of confidentiality.

6.7.9.4 Documentation of record destruction must be maintained by the home health agency.

6.7.9.5 At least 30 calendar days before the home health agency discontinues operations, it must inform the Department where patient records will be maintained.

6.7.10 Records shall be protected from loss, damage and unauthorized use.

6.7.11 The home health agency must develop acceptable policies for authentication of any computerized records.

6.7.12 Report of Major Adverse Incidents

6.7.12.1 The home health agency must report all major adverse incidents, occurring in the presence of a home health employee/contractor, involving a patient to the Department within 48 hours in addition to other reporting requirements required by law.

6.7.12.2 A major adverse incident includes but is not limited to:

6.7.12.2.1 Suspected abuse, neglect, mistreatment, financial exploitation, solicitation or harassment;

6.7.12.2.2 An accident that causes serious injury to a patient;

6.7.12.2.3 A medication error with the potential to result in adverse health outcomes for the patient; or

6.7.12.2.4 The unexpected death of a patient.

6.7.12.3 Major adverse incidents must be investigated by the agency.

6.7.12.4 A complete report will be forwarded to the Department within 30 calendar days of occurrence or of the date that the agency first became aware of the incident.

6.8 Discharge

6.8.1 The patient, or her/his representative if any, shall be informed of and participate in discharge planning.

6.8.2 The home health agency shall develop a written plan of discharge which includes a summary of services provided and outlines the services needed by the patient upon discharge.

6.8.2.1 The plans for the patient’s discharge and any revisions must be communicated to all physicians and allowable providers participating in the patient’s care and the patient’s primary physician or allowable provider or other health care professionals who will be responsible for providing care and services to the patient after discharge (if any).

6.8.3 When discharging a patient who does not wish to be discharged, a minimum of 2 weeks notice will be provided to permit the patient to obtain an alternate service provider. Exceptions to the 2-week notice provision would include:

6.8.3.1 The discharge of patients when care goals have been met.

6.8.3.2 The discharge of patients when care needs undergo a change which necessitates transfer to a higher level of care and for whom a new discharge plan needs to be developed.

6.8.3.3 The discharge of patients when there is documented non-compliance with the plan of care or the admission agreement (including, but not limited to, non-payment of justified charges).

6.8.3.4 The discharge of patients when activities or circumstances in the home jeopardize the welfare and safety of the home health agency caregiver.

6.9 Infection Prevention and Control

6.9.1 The agency shall establish an infection prevention and control program which shall be based upon Centers for Disease Control and Prevention and other nationally recognized infection prevention and control guidelines. The infection prevention and control program must include all services offered by the agency, including the appropriate personal protective equipment for all patients and staff.

6.9.2 The individual designated to lead the agency’s infection prevention and control program must develop and implement a comprehensive plan that includes actions to prevent, identify and manage infections and communicable diseases. The plan of action must include mechanisms that result in immediate action to take preventive or corrective measures that improve the Skilled Home Health Agency’s infection control outcomes.

6.9.3 All agency staff shall receive orientation at the time of employment and annual in-service education regarding the infection prevention and control program.

6.9.4 Specific Requirements for COVID-19

6.9.4.1 Before their start date, all new staff, vendors, and volunteers must be tested for COVID-19 in accordance with Division of Public Health guidance.

6.9.4.2 All staff, vendors, and volunteers must be tested for COVID-19 in a manner consistent with Division of Public Health guidance.

6.9.4.3 The skilled home health agency must follow recommendations of the Centers for Disease Control and Prevention and the Division of Public Health regarding the provision of care or services to patients by staff, vendor or volunteer found to be positive for COVID-19 in an infectious stage.

6.9.5 The skilled home health agency shall amend their policies and procedures to include:

6.9.5.1 Work exclusion and return to work protocols for staff tested positive for COVID-19;

6.9.5.2 Staff refusals to participate in COVID-19 testing;

6.9.5.3 Staff refusals to authorize release of testing results or vaccination status to the skilled home health agency;

6.9.5.4 Procedures to obtain staff authorizations for release of laboratory test results to the skilled home health agency to inform infection control and prevention strategies; and

6.9.5.5 Plans to address staffing shortages and the skilled home health agency demands should a COVID-19 outbreak occur.

**History**
- *12 DE Reg. 1217 (03/01/09)*
- *18 DE Reg. 133 (08/01/14)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *27 DE Reg. 44 (07/01/23)*
- *12 DE Reg. 1217 (03/01/09)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *12 DE Reg. 1217 (03/01/09)*
- *15 DE Reg. 220 (08/01/11)*
- *19 DE Reg. 641 (01/01/16)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *27 DE Reg. 44 (07/01/23)*
- *12 DE Reg. 1217 (03/01/09)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *25 DE Reg. 773 (02/01/22)*
- *27 DE Reg. 44 (07/01/23)*
- *12 DE Reg. 1217 (03/01/09)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *12 DE Reg. 1217 (03/01/09)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *18 DE Reg. 133 (08/01/14)*
- *25 DE Reg. 527 (11/01/21)*
- *25 DE Reg. 773 (02/01/22)*
- *27 DE Reg. 44 (07/01/23)*

##### **16 Del. Admin. Code § 3350-7.0** Patient Rights {#sec-3350-7.0 omnilex-key=us-de-regs-official--title-16--3350-7.0}

7.1 The home health agency must provide the patient with a written notice of the patient’s rights during the initial assessment visit or before initiation of care.

7.2 Each patient shall have the right to:

7.2.1 Be treated with courtesy, consideration, respect and dignity;

7.2.2 Be encouraged and supported in maintaining one’s independence to the extent that conditions and circumstances permit, and to be involved in a program of services designed to promote personal independence;

7.2.3 Self-determination and choice, including the opportunity to participate in developing one’s plan of care;

7.2.4 Privacy and confidentiality;

7.2.5 Be protected from abuse, neglect, mistreatment, financial exploitation, solicitation and harassment;

7.2.6 Voice grievances without discrimination or reprisal;

7.2.7 Be fully informed, as evidenced by the patient’s written acknowledgment of these rights, and of all rules and regulations regarding patient conduct and responsibilities;

7.2.8 Be fully informed, at the time of admission into the program, of services and activities available and related charges;

7.2.9 Be served by individuals who are properly trained and competent to perform their duties; and

7.2.10 Refuse care and to be informed of possible health consequences of the refusal.

7.3 The agency must establish a process for the prompt resolution of grievances, which must include:

7.3.1 The procedure for the submission of a written or verbal grievance;

7.3.2 The timeframes for review of the grievance and the provision of a response; and

7.3.3 A written notice of the decision to the patient/representative that contains the name of the agency contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion.

**History**
- *12 DE Reg. 1217 (03/01/09)*
- *18 DE Reg. 133 (08/01/14)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *27 DE Reg. 44 (07/01/23)*
- *12 DE Reg. 1217 (03/01/09)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *12 DE Reg. 1217 (03/01/09)*
- *15 DE Reg. 220 (08/01/11)*
- *19 DE Reg. 641 (01/01/16)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *27 DE Reg. 44 (07/01/23)*
- *12 DE Reg. 1217 (03/01/09)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *25 DE Reg. 773 (02/01/22)*
- *27 DE Reg. 44 (07/01/23)*
- *12 DE Reg. 1217 (03/01/09)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *12 DE Reg. 1217 (03/01/09)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *18 DE Reg. 133 (08/01/14)*
- *25 DE Reg. 527 (11/01/21)*
- *25 DE Reg. 773 (02/01/22)*
- *27 DE Reg. 44 (07/01/23)*

##### **16 Del. Admin. Code § 3350-8.0** Quality Improvement {#sec-3350-8.0 omnilex-key=us-de-regs-official--title-16--3350-8.0}

8.1 Each home health agency shall develop and implement a documented ongoing quality improvement program. The program shall include at a minimum:

8.1.1 An internal monitoring process that tracks performance measures;

8.1.2 A review of the program’s goals and objectives at least annually;

8.1.3 A review of the grievance/complaint process;

8.1.4 A review of all unexpected patient deaths;

8.1.5 A review of all medication errors;

8.1.6 A review of actions taken to address identified issues; and

8.1.7 A process to monitor the satisfaction of the patients or their representatives with the program.

**History**
- *12 DE Reg. 1217 (03/01/09)*
- *18 DE Reg. 133 (08/01/14)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *27 DE Reg. 44 (07/01/23)*
- *12 DE Reg. 1217 (03/01/09)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *12 DE Reg. 1217 (03/01/09)*
- *15 DE Reg. 220 (08/01/11)*
- *19 DE Reg. 641 (01/01/16)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *27 DE Reg. 44 (07/01/23)*
- *12 DE Reg. 1217 (03/01/09)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *25 DE Reg. 773 (02/01/22)*
- *27 DE Reg. 44 (07/01/23)*
- *12 DE Reg. 1217 (03/01/09)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *12 DE Reg. 1217 (03/01/09)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *18 DE Reg. 133 (08/01/14)*
- *25 DE Reg. 527 (11/01/21)*
- *25 DE Reg. 773 (02/01/22)*
- *27 DE Reg. 44 (07/01/23)*

##### **16 Del. Admin. Code § 3350-9.0** Insurance {#sec-3350-9.0 omnilex-key=us-de-regs-official--title-16--3350-9.0}

The home health agency shall have appropriate insurance coverage in force to compensate patients for injuries and losses resulting from services provided by the agency.

**History**
- *12 DE Reg. 1217 (03/01/09)*
- *18 DE Reg. 133 (08/01/14)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *27 DE Reg. 44 (07/01/23)*
- *12 DE Reg. 1217 (03/01/09)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *12 DE Reg. 1217 (03/01/09)*
- *15 DE Reg. 220 (08/01/11)*
- *19 DE Reg. 641 (01/01/16)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *27 DE Reg. 44 (07/01/23)*
- *12 DE Reg. 1217 (03/01/09)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *25 DE Reg. 773 (02/01/22)*
- *27 DE Reg. 44 (07/01/23)*
- *12 DE Reg. 1217 (03/01/09)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *12 DE Reg. 1217 (03/01/09)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *18 DE Reg. 133 (08/01/14)*
- *25 DE Reg. 527 (11/01/21)*
- *25 DE Reg. 773 (02/01/22)*
- *27 DE Reg. 44 (07/01/23)*

##### **16 Del. Admin. Code § 3350-10.0** Disaster Preparedness {#sec-3350-10.0 omnilex-key=us-de-regs-official--title-16--3350-10.0}

10.1 Each home health agency shall prepare and maintain a comprehensive emergency management plan that is consistent with the national standards (i.e., FEMA, ASPR, TRACIE) and consistent with the local and State plans.

10.2 The plan shall:

10.2.1 Provide for continuing home health services during an emergency that interrupts patient care or services in the patient's home;

10.2.2 Describe how the home health agency establishes and maintains an effective response to emergencies and disasters, including:

10.2.2.1 Notification of staff when emergency response measures are initiated;

10.2.2.2 Provision for communication with and between staff members, local emergency management agencies, the State emergency management agency and patients;

10.2.2.3 Provision for a backup system;

10.2.2.4 Identification of resources necessary to continue essential care and services; and

10.2.2.5 Prioritization of patient care needs and services.

10.3 All agency staff must be oriented to the disaster preparedness plan(s). Records of staff attendance must be maintained.

10.4 A copy of the disaster preparedness plan(s) shall be available to all staff.

10.5 Each home health agency shall inform patients and patients’ caregivers, upon admission, of the agency’s procedures during and immediately following an emergency.

**History**
- *12 DE Reg. 1217 (03/01/09)*
- *18 DE Reg. 133 (08/01/14)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *27 DE Reg. 44 (07/01/23)*
- *12 DE Reg. 1217 (03/01/09)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *12 DE Reg. 1217 (03/01/09)*
- *15 DE Reg. 220 (08/01/11)*
- *19 DE Reg. 641 (01/01/16)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *27 DE Reg. 44 (07/01/23)*
- *12 DE Reg. 1217 (03/01/09)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *25 DE Reg. 773 (02/01/22)*
- *27 DE Reg. 44 (07/01/23)*
- *12 DE Reg. 1217 (03/01/09)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *12 DE Reg. 1217 (03/01/09)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *18 DE Reg. 133 (08/01/14)*
- *25 DE Reg. 527 (11/01/21)*
- *25 DE Reg. 773 (02/01/22)*
- *27 DE Reg. 44 (07/01/23)*

##### **16 Del. Admin. Code § 3350-11.0** Severability {#sec-3350-11.0 omnilex-key=us-de-regs-official--title-16--3350-11.0}

In the event any particular clause or section of these regulations should be declared invalid or unconstitutional by any court of competent jurisdiction, the remaining portions shall remain in full force and effect.

**History**
- *12 DE Reg. 1217 (03/01/09)*
- *18 DE Reg. 133 (08/01/14)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *27 DE Reg. 44 (07/01/23)*
- *12 DE Reg. 1217 (03/01/09)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *12 DE Reg. 1217 (03/01/09)*
- *15 DE Reg. 220 (08/01/11)*
- *19 DE Reg. 641 (01/01/16)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *27 DE Reg. 44 (07/01/23)*
- *12 DE Reg. 1217 (03/01/09)*
- *19 DE Reg. 849 (03/01/16)*
- *25 DE Reg. 527 (11/01/21)*
- *25 DE Reg. 773 (02/01/22)*
- *27 DE Reg. 44 (07/01/23)*
- *12 DE Reg. 1217 (03/01/09)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *12 DE Reg. 1217 (03/01/09)*
- *25 DE Reg. 527 (11/01/21)*
- *12 DE Reg. 1217 (03/01/09)*
- *18 DE Reg. 133 (08/01/14)*
- *25 DE Reg. 527 (11/01/21)*
- *25 DE Reg. 773 (02/01/22)*
- *27 DE Reg. 44 (07/01/23)*

#### **3351** Home Health Agencies--Aide Only (Licensure)

##### **16 Del. Admin. Code § 3351-1.0** Definitions {#sec-3351-1.0 omnilex-key=us-de-regs-official--title-16--3351-1.0}

The following words and terms, when used in this regulation, should have the following meaning unless the context clearly indicates otherwise:

“Activities of daily living” means the tasks for self-care which are performed either independently, with supervision, or with assistance. Activities of daily living include ambulating, transferring, grooming, bathing, dressing, eating and toileting.

“Agency” means a home health agency licensed by the Department.

“Bylaws” means a set of rules adopted by a home health agency for governing the agency’s operation.

“Change of Ownership (CHOW)” see “Modification of Ownership and Control (MOC)”.

“Clinical Director” means a registered nurse who is sufficiently qualified to provide general supervision and direction of the services offered by the home health agency and who has at least 1 year of home health care and administrative/supervisory health care experience. The “Clinical Director” and “Director” may be the same individual if that individual is dually qualified.

“Companion Services” means provision of social interaction for an individual primarily in her/his place of residence. A companion may provide such services as cooking, housekeeping, errands, etc.

“Complaint” means a formal or informal written or verbal notification of patient issues that can be immediately addressed by staff who are present at the time of the complaint.

“Contractor” means an agency that holds a valid business license and provides staffing services to the home health agency.

“Department” means the Delaware Department of Health and Social Services.

“Director” means the individual appointed by the governing body to act on its behalf in the overall management of the home health agency. The director shall:

(1) Have a baccalaureate degree with 5 years health care experience and at least 1 year supervisory experience (full-time or equivalent) in home health care; or

(2) Be a registered nurse with 5 years health care experience and at least 1 year of supervisory experience (full-time or equivalent) in home health care.

“Full-time” means the established business hours of the home health agency.

“Governing Body or Other Legal Authority” means the individual, partnership, agency, group, or corporation designated to assume full legal responsibility for the policy determination, management, operation and financial liability of the home health agency.

“Grievance” means a formal or informal written or verbal complaint that is made to the agency by a patient, or the patient’s representative. A grievance cannot be immediately resolved by staff present at the time of the complaint.

“Health care Experience” means the direct participation of an individual in the maintenance or improvement of health via the prevention, diagnosis, treatment, recovery, or cure of disease, illness, injury, and other physical and mental impairments in patients.

“Health Care Facility” means any facility licensed under 16 Del.C. Ch.10 or 11.

“Home Health Agency (HHA)” means any business entity or sub-division thereof, whether public or private, proprietary or not-for-profit, which provides home health aide services, medication reminders, to an individual primarily in their place of residence.

“Home Health Aide” means a non-licensed person employed by the agency who provides personal care services, companion services, homemaker services, transportation services and who may perform tasks delegated by a licensed nurse as permitted by 24 Del.C. Ch. 19. A home health aide (A) has at least 1 year of practical experience in a Department licensed or approved hospital, nursing home, or home care setting; or (B) has satisfactorily completed an appropriate home care course which includes the training requirements contained within these regulations; or (C) is a student nurse pursuing a degree in nursing who has completed the clinical practicum portion of their training.

“Home Health Aide Care Plan” means a written plan developed by the nurse that specifies the tasks that are to be performed by the aide primarily in the patient’s residence. The written plan specifies scope, frequency and duration of services.

“Home Health Aide Services” means services, provided to an individual primarily in their place of residence, that are limited to personal care services, companion services, homemaker services, medication reminders, and tasks delegated by a licensed nurse as permitted by 24 Del.C. Ch. 19.

“Home Health Care Experience” means the provision of services by a home health agency to meet the needs of patients being cared for in their residence for an illness or injury.

“Homemaker Services” means performance of household chores for an individual, primarily in her/his place of residence. Household chores may include but are not necessarily limited to housekeeping, meal preparation and shopping.

“Immediate Jeopardy” means a crisis situation in which the health and safety of patients is at risk. It is a deficient practice which indicates an inability to furnish safe care and services.

“Legal Entity” means a business organizational structure that is recognized as such by 6 Del.C. or 8 Del.C.

“License” means a license issued by the Department.

“Licensee” means the individual, corporation or legal entity with whom rests the ultimate responsibility for maintaining approved standards for the home health agency.

“Located” means the physical address of the agency’s business office.

“Majority Interest” means the largest percentage of ownership interest.

“Medication Reminder” means a verbal prompt to the patient to take their medication. A medication reminder does not include the administration or any physical touching of the medication.

“Minority Interest” means any percentage of ownership less than the majority interest.

“Modification of Ownership and Control (MOC)” means the sale, purchase, transfer or re-organization of ownership rights.

“Nurse” means an individual who is currently licensed to practice nursing pursuant to 24 Del.C. Ch. 19.

“Office” means the physical location in which the business of the home health agency is conducted and in which the records of personnel, contractors and patients of the agency are stored. The office shall be located in the State of Delaware.

“Owner” means an individual or legal entity with ownership rights of the agency.

“Ownership” means the state or fact of exclusive possession and control of the agency.

“Ownership Interest” means the percentage of ownership an individual or legal entity possesses.

“Patient” means the individual receiving home health agency services as defined in this chapter.

“Patient Record” means a written account of all services provided to a patient by the home health agency, as well as other pertinent information necessary to provide care.

“Personal Care Services” means the provision of services that do not require the judgment and skills of a licensed nurse or other professional. The services are limited to individual assistance with/or supervision of activities of daily living, companion services, transportation services, homemaker services, reporting changes in patient's condition and completing reports.

“Plan of Care” see “Home Health Aide Care Plan”.

“Plan of Correction” means a home health agency’s written response to findings of regulatory non-compliance. Plans must adhere to the format specified by the licensing agency, must include acceptable timeframes in which deficiencies will be corrected and must be approved by the licensing agency.

“Representative” means a person acting on behalf of the patient under Delaware law.

“Residence” means the domicile of the patient either personally owned by that patient or considered the place of residence of that patient where the home health aide services will be provided.

“Serious Injury” means physical injury that creates a substantial risk of death, or that causes serious disfigurement, serious impairment of health or serious loss or impairment of the function of any bodily organ.

“Service Area” means the county in the state of Delaware in which the agency office is located and may include the county or counties in the state of Delaware which are immediately adjacent.

“Supervision of Services” means authoritative procedural guidance by a qualified person for the accomplishment of a function or activity with initial direction and periodic inspection of the actual act of accomplishing the function or activity.

"Telehealth Mechanism" means the use of information exchange from 1 site to another via an electronic interactive telecommunication system. Telehealth is provided with specialized equipment at each site including real-time streaming via the use of video streaming and audio equipment. The telecommunications must permit real-time encryption of the interactive audio and video exchanges with the home health agency. The consumer must consent to the use of telehealth.

**History**
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *27 DE Reg. 45 (07/01/23)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *12 DE Reg. 1209 (03/01/09)*
- *15 DE Reg. 220 (08/01/11)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *27 DE Reg. 45 (07/01/23)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *27 DE Reg. 45 (07/01/23)*
- *12 DE Reg. 1209 (03/01/09)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *12 DE Reg. 1209 (03/01/09)*
- *25 DE Reg. 521 (11/01/21)*
- *25 DE Reg. 521 (11/01/21)*
- *25 DE Reg. 774 (02/01/22)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *25 DE Reg. 774 (02/01/22)*
- *27 DE Reg. 45 (07/01/23)*

##### **16 Del. Admin. Code § 3351-2.0** Licensing Requirements and Procedures {#sec-3351-2.0 omnilex-key=us-de-regs-official--title-16--3351-2.0}

2.1 General Requirements

2.1.1 No person, shall establish, conduct or maintain in this state any home health agency without first obtaining a license from the Department.

2.1.2 A separate license shall be required for each office maintained by a home health agency.

2.1.3 The home health agency shall advise the Department in writing at least 30 calendar days prior to any change in office location.

2.1.4 Any agency that undergoes a modification of ownership and control is required to re-apply as a new agency.

2.1.5 A license is not transferable from person to person or from entity to entity.

2.1.6 The license shall be posted in a conspicuous place on the licensed premises.

2.1.7 The agency shall only provide services in the service area. The agency may provide services to a patient during the patient’s time-limited travel outside the service area.

2.2 Application Process

2.2.1 All persons or entities applying for a license shall submit a written statement of intent to the Department describing the services to be offered by the agency and requesting a licensure application from the Department.

2.2.1.1 The issuance of an application form is in no way a guarantee that the completed application will be accepted or that a license will be issued by the Department.

2.2.1.2 No person or entity shall hold themselves out to the public as being a home health agency until a license has been issued by the Department.

2.2.2 In addition to a completed application for licensure, applicants shall submit to the Department the following information:

2.2.2.1 The names, addresses and types of agencies owned or managed by the applicant;

2.2.2.2 A copy of the applicant’s policies and procedures manual as requested by the Department;

2.2.2.3 Identity of:

2.2.2.3.1 Each officer and director of the corporation if the entity is organized as a corporation;

2.2.2.3.2 Each general partner or managing member if the entity is organized as an unincorporated entity;

2.2.2.3.3 The governing body;

2.2.2.3.4 Any officers/directors, partners, managing members or members of a governing body who have a financial interest of 5% or more in a licensee’s operation or related businesses;

2.2.2.4 Disclosure of any officer, director, partner, employee, managing member or member of the governing body with a felony criminal record;

2.2.2.5 Name of the individual (director) who is responsible for the management of the home health agency;

2.2.2.6 A list of management personnel, including credentials;

2.2.2.7 A plan for providing continuing education and training for agency personnel or contractors during the first year of operation; and

2.2.2.8 Any other information required by the Department.

2.3 Issuance of Licenses

2.3.1 Initial license

2.3.1.1 An initial license shall be granted for a period of 90 calendar days to every agency that completes the application process consistent with these regulations and whose policies and procedures demonstrate compliance with the rules and regulations pertaining to home health agency – aide only licensure.

2.3.1.2 All home health agencies shall have an on-site survey during the first 90 calendar days of operation.

2.3.1.3 A home health agency, at the time of an initial on-site survey, must meet the definition of a home health agency as contained within these regulations and must be in operation and caring for patients. Agencies that, at the time of an on-site survey, do not meet the definition of a home health agency or that are not in substantial compliance with these regulations will not be granted a license.

2.3.1.4 An initial license will permit an agency to hire home health aides and establish a patient caseload.

2.3.1.5 An initial license may not be renewed.

2.3.2 Provisional license

2.3.2.1 A provisional license may be granted for a period of less than 1 year to all home health agencies that:

2.3.2.1.1 Are not in substantial compliance with these rules and regulations; or

2.3.2.1.2 Fail to renew a license within the timeframe prescribed by these regulations.

2.3.2.2 The Department shall designate the conditions and the time period under which a provisional license is issued.

2.3.2.3 A provisional license, issued to an agency that is not in substantial compliance with these regulations, may not be renewed unless a plan of correction for coming into substantial compliance with these rules and regulations has been approved by the Department and implemented by the home health agency.

2.3.2.4 A license will not be granted pursuant to 2.3.3 after the provisional licensure period to any agency that is not in substantial compliance with these rules and regulations.

2.3.3 Annual License

2.3.3.1 An annual license shall be granted for a period of 1 year (12 months) to all home health agencies which are in substantial compliance with these rules and regulations at the time of application.

2.3.3.2 An annual license shall be effective for a 12-month period following date of issue and shall expire 1 year following the issue date, unless it is: modified to a provisional, suspended or revoked, or surrendered prior to the expiration date.

2.3.3.3 Existing home health agencies must apply for renewal of licensure at least 30 calendar days prior to the expiration date of the license.

2.3.3.4 A license may not be issued to a home health agency:

2.3.3.4.1 Which does not meet the definition of a home health agency as contained within these regulations;

2.3.3.4.2 Which is not in substantial compliance with these regulations; or

2.3.3.4.3 Whose deficient practices present an immediate threat to the health and safety of its patients.

2.4 Disciplinary proceedings

2.4.1 The Department may impose sanctions (subsection 2.4.2 of this section) singly or in combination when it finds a licensee or former licensee has:

2.4.1.1 Violated any of these regulations;

2.4.1.2 Failed to submit a reasonable timetable for correction of deficiencies;

2.4.1.3 Exhibited a pattern of cyclical deficiencies which extends over a period of two or more years;

2.4.1.4 Failed to correct deficiencies in accordance with a timetable submitted by the applicant and agreed upon by the Department;

2.4.1.5 Engaged in any conduct or practices detrimental to the welfare of the patients;

2.4.1.6 Exhibited incompetence, negligence, or misconduct in operating the home health agency or in providing services to patients;

2.4.1.7 Mistreated or abused patients cared for by the home health agency;

2.4.1.8 Violated any statutes relating to Medical Assistance or Medicare reimbursement for those agencies who participate in those programs; or

2.4.1.9 Refused to allow the Department access to the agency or records for the purpose of conducting inspections/surveys/investigations as deemed necessary by the Department.

2.4.2 Disciplinary sanctions may include:

2.4.2.1 Permanently revoke a license.

2.4.2.2 Suspend a license.

2.4.2.3 Issue a letter of reprimand.

2.4.2.4 Place a licensee on provisional status and require the licensee to:

2.4.2.4.1 Report regularly to the Department upon the matters which are the basis of the provisional status;

2.4.2.4.2 Limit practice to those areas prescribed by the Department; or

2.4.2.4.3 Suspend new intakes and admissions.

2.4.2.5 Refuse a license.

2.4.2.6 Refuse to renew a license.

2.4.2.7 The Department may request the Superior Court to impose a civil penalty of not more than $10,000 for a violation of these regulations. Each day a violation continues constitutes a separate violation.

2.4.2.7.1 In lieu of seeking a civil penalty, the Department, at its discretion, may impose an administrative penalty of not more than $10,000 for a violation of these regulations. Each day a violation continues constitutes a separate violation.

2.4.2.7.2 In determining the amount of any civil or administrative penalty imposed, the Court or the Department shall consider the following factors:

2.4.2.7.2.1 The seriousness of the violation, including the nature, circumstances, extent and gravity of the violation and the threat or potential threat to the health or safety of a patient(s);

2.4.2.7.2.2 The history of violations committed by the person or the person's affiliate(s), agents, employee(s) or controlling person(s);

2.4.2.7.2.3 The efforts made by the agency to correct the violation(s);

2.4.2.7.2.4 Any misrepresentation made to the Department; and

2.4.2.7.2.5 Any other matter that affects the health, safety or welfare of a patient(s).

2.4.2.8 Otherwise discipline.

2.4.3 Imposition of Disciplinary Action

2.4.3.1 Before any disciplinary action is taken (except as authorized by 2.4.4):

2.4.3.1.1 The Department shall give 20 calendar days written notice to the holder of the license, setting forth the reasons for the determination.

2.4.3.1.2 The disciplinary action shall become final 20 calendar days after the mailing of the notice unless the licensee, within such 20 calendar day period, shall give written notice of the agency’s desire for a hearing.

2.4.3.1.3 If the licensee gives such notice, the agency shall be given a hearing before the Secretary of the Department or her/his designee and may present such evidence as may be proper.

2.4.3.1.4 The Secretary of the Department or her/his designee shall make a determination based upon the evidence presented.

2.4.3.1.5 A written copy of the determination and the reasons upon which it is based shall be sent to the agency.

2.4.3.1.6 The decision shall become final 20 calendar days after the mailing of the determination letter unless the licensee, within the 20 calendar day period, appeals the decision to the appropriate court of the state.

2.4.4 Order to immediately suspend a license

2.4.4.1 In the event the Department identifies activities which the Department determines present an immediate jeopardy or imminent danger to the public health, welfare and safety requiring emergency action, the Department may issue an order temporarily suspending the licensee's license, pending a final hearing on the complaint. No order temporarily suspending a license shall be issued by the Department, with less than 24 hours prior written or oral notice to the licensee or the licensee's attorney so that the licensee may be heard in opposition to the proposed suspension. An order of temporary suspension under this section shall remain in effect for a period not longer than 60 calendar days from the date of the issuance of said order, unless the suspended licensee requests a continuance of the date for the final hearing before the Department. If a continuance is requested, the order of temporary suspension shall remain in effect until the Department has rendered a decision after the final hearing.

2.4.4.2 The licensee, whose license has been temporarily suspended, shall be notified forthwith in writing. Notification shall consist of a copy of the deficiency report and the order of temporary suspension pending a hearing and shall be personally served upon the licensee or sent by mail, return receipt requested, to the licensee's last known address.

2.4.4.3 A licensee whose license has been temporarily suspended pursuant to this section may request an expedited hearing. The Department shall schedule the hearing on an expedited basis provided that the Department receives the licensee's written request for an expedited hearing within 5 calendar days from the date on which the licensee received notification of the Department's decision to temporarily suspend the licensee's license.

2.4.4.4 As soon as possible, but in no event later than 60 calendar days after the issuance of the order of temporary suspension, the Department shall convene for a hearing on the reasons for suspension. In the event that a licensee, in a timely manner, requests an expedited hearing, the Department shall convene within 15 calendar days of the receipt by the Department of such a request and shall render a decision within 30 calendar days.

2.4.4.5 In no event shall an order of temporary suspension remain in effect for longer than 60 calendar days unless the suspended licensee requests an extension of the order of temporary suspension pending a final decision of the Department. Upon a final decision of the Department, the order of temporary suspension may be vacated in favor of the disciplinary action ordered by the Department.

2.4.5 Termination of license

2.4.5.1 Termination of a license to provide services as a home health agency occurs secondary to:

2.4.5.1.1 Revocation of a license or the voluntary surrender of a license in avoidance of revocation action.

2.4.5.2 Termination of rights to provide services extends to:

2.4.5.2.1 Agency;

2.4.5.2.2 Owner(s);

2.4.5.2.3 Officers/Directors, partners, managing members, or members of a governing body who have a financial interest of 5% or more in the home health agency; and

2.4.5.2.4 Corporation officers.

2.5 Modification of Ownership and Control (MOC)

2.5.1 Any proposed MOC must be reported to the Department a minimum of 30 calendar days prior to the change.

2.5.2 A MOC voids the current license in possession of the agency.

2.5.3 A MOC may include but is not limited to:

2.5.3.1 Transfer of full ownership rights;

2.5.3.2 Transfer of the majority interest;

2.5.3.3 Transfer of ownership interests that result in the owner with the majority interest becoming a minority interest owner;

2.5.3.4 Transfer or re-organization that results in an additional majority interest that is equal in ownership rights; or

2.5.3.5 Transfer resulting in a measurable impact upon the operational control of the agency.

2.6 Fees. Fees shall be in accordance with 16 Del.C. §122 (3)o.

2.7 Inspection. A representative of the Department shall periodically inspect every home health agency for which a license has been issued under this chapter. Inspections by authorized representatives of the Department may occur at any time and may be scheduled or unannounced.

2.8 Notice to Patients. The home health agency shall notify each patient or the patient's authorized representative, the patient's attending physician (as appropriate), and any third-party payers at least thirty (30) calendar days before the voluntary surrender of its license, or as directed under an order of denial, revocation, or suspension of license issued by the Department.

2.9 Exclusions from Licensure. The following persons, associations or organizations are not required to obtain a home health agency license:

2.9.1 Those individuals who contract directly with a patient to provide services for that patient, where the patient pays the individual for services rendered and neither the patient nor the individual pays an agency on a periodic basis.

2.9.2 Those agencies that provide only durable medical equipment and supplies for in-home use.

2.9.3 Those agencies that provide staff to licensed home health agencies, such as temporary employment/staffing agencies.

2.9.3.1 Temporary employment/staffing agencies may not provide services under direct agreements with patients.

2.9.3.2 Temporary employment/staffing agencies must be contractually bound to perform services under the contracting providers’ direction and supervision.

2.9.3.3 Temporary staff working for a licensed provider must meet the requirements of these regulations.

2.9.4 Any visiting nurse service or home health services conducted by and for those who rely upon spiritual means through prayer alone for healing in accordance with the tenets and practices of a registered church or religious denomination.

2.9.5 An agency which solely provides services as defined in 16 Del.C. Ch. 94, the Community Based Attendant Services Act.

2.9.6 A Personal Assistance Services Agency which solely provides services defined in 16 Del.C. §122(3)x.

**History**
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *27 DE Reg. 45 (07/01/23)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *12 DE Reg. 1209 (03/01/09)*
- *15 DE Reg. 220 (08/01/11)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *27 DE Reg. 45 (07/01/23)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *27 DE Reg. 45 (07/01/23)*
- *12 DE Reg. 1209 (03/01/09)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *12 DE Reg. 1209 (03/01/09)*
- *25 DE Reg. 521 (11/01/21)*
- *25 DE Reg. 521 (11/01/21)*
- *25 DE Reg. 774 (02/01/22)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *25 DE Reg. 774 (02/01/22)*
- *27 DE Reg. 45 (07/01/23)*

##### **16 Del. Admin. Code § 3351-3.0** General Requirements {#sec-3351-3.0 omnilex-key=us-de-regs-official--title-16--3351-3.0}

3.1 All records maintained by the home health agency shall at all times be open to inspection by the authorized representatives of the Department.

3.2 No policies shall be adopted by the home health agency which are in conflict with these regulations.

3.3 Reports of incidents, accidents and medical emergencies shall be kept on file at the agency for a minimum of 6 years.

3.4 The home health agency shall advise the Department in writing within 30 calendar days following any change in the designation of the director or clinical director within the agency.

3.5 The home health agency may contract with a staffing agency for services to be provided to its patients when the home health agency is not able to meet staffing needs. Individuals providing services under contract must meet the same requirements as those persons employed directly by the agency.

3.6 The director or clinical director shall be available at all times during the operating hours of the home health agency.

3.7 The home health agency shall advise the Department in writing at least 30 calendar days prior to any change in office location.

3.8 The home health agency must permit photocopying of any records or other information by, or on behalf of authorized representatives of the Department, as necessary to determine or verify compliance with these regulations.

3.9 The agency shall have policies and an operational system which assure uninterrupted implementation of the plan of care. In furtherance of this requirement, the agency shall, at a minimum: 1) maintain a sufficient pool of qualified employees/contractors to fulfill plans of care and provide scheduled services; and 2) develop and maintain a back-up system to provide substitute employees/contractors if regularly scheduled employees/contractors are unavailable.

3.10 The agency shall be in compliance with federal, state and local laws and codes.

3.11 Prior to the provision of services in a health care facility, the home health agency must obtain written permission from each health care facility in which services will be provided.

**History**
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *27 DE Reg. 45 (07/01/23)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *12 DE Reg. 1209 (03/01/09)*
- *15 DE Reg. 220 (08/01/11)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *27 DE Reg. 45 (07/01/23)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *27 DE Reg. 45 (07/01/23)*
- *12 DE Reg. 1209 (03/01/09)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *12 DE Reg. 1209 (03/01/09)*
- *25 DE Reg. 521 (11/01/21)*
- *25 DE Reg. 521 (11/01/21)*
- *25 DE Reg. 774 (02/01/22)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *25 DE Reg. 774 (02/01/22)*
- *27 DE Reg. 45 (07/01/23)*

##### **16 Del. Admin. Code § 3351-4.0** Governing Body {#sec-3351-4.0 omnilex-key=us-de-regs-official--title-16--3351-4.0}

4.1 Each home health agency shall have an organized governing body (governing authority, owner or person(s) designated by the owner).

4.2 The governing body shall be ultimately responsible for:

4.2.1 The management and control of the agency;

4.2.2 The assurance of quality care and services;

4.2.3 Compliance with all federal, state and local laws and regulations;

4.2.4 Adoption of written policies and procedures which describe the functions and services of the agency;

4.2.5 Providing a sufficient number of appropriately qualified personnel;

4.2.6 Providing physical resources and equipment, supplies and services for the provision of safe, effective and efficient delivery of care services;

4.2.7 Developing an organizational structure establishing lines of authority and responsibility;

4.2.8 Appointing a qualified director;

4.2.9 Appointing members of the clinical staff, ensuring their competence and delineating their clinical privileges;

4.2.10 Conducting meetings, when the governing body is more than 1 person, at least annually and maintaining written minutes of the meeting(s);

4.2.11 Annual review and evaluation of the agency policies and services; and

4.2.12 Other relevant health and safety requirements.

4.3 There shall be a description of each type of service offered.

4.4 There shall be written policies and procedures pertaining to each service offered.

4.5 There shall be a description of the system for the maintenance of patient records.

4.6 Bylaws shall be reviewed annually by the governing body and so dated. Revisions shall be completed as necessary.

**History**
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *27 DE Reg. 45 (07/01/23)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *12 DE Reg. 1209 (03/01/09)*
- *15 DE Reg. 220 (08/01/11)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *27 DE Reg. 45 (07/01/23)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *27 DE Reg. 45 (07/01/23)*
- *12 DE Reg. 1209 (03/01/09)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *12 DE Reg. 1209 (03/01/09)*
- *25 DE Reg. 521 (11/01/21)*
- *25 DE Reg. 521 (11/01/21)*
- *25 DE Reg. 774 (02/01/22)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *25 DE Reg. 774 (02/01/22)*
- *27 DE Reg. 45 (07/01/23)*

##### **16 Del. Admin. Code § 3351-5.0** Administration/Personnel {#sec-3351-5.0 omnilex-key=us-de-regs-official--title-16--3351-5.0}

5.1 Director

5.1.1 There shall be a full-time agency director.

5.1.2 The director shall have the overall authority and responsibility for the daily operation and management of the agency.

5.1.3 The authority, duties and responsibilities of the director shall be defined in writing and shall include but not be limited to:

5.1.3.1 Interpretation and execution of the policies adopted by the governing body;

5.1.3.2 Program planning, budgeting, management and program evaluation;

5.1.3.3 Maintenance of the agency’s compliance with licensure regulations and standards;

5.1.3.4 Preparation and submission of required reports;

5.1.3.5 Distribution of a written plan for the delegation of administrative responsibilities and functions in the absence of the director;

5.1.3.6 Documentation of complaints and grievances relating to the conduct or actions by employees/contractors and action taken secondary to the complaints or grievances;

5.1.3.7 Conducting or supervising the resolution of complaints and grievances received from patients in the delivery of care or services by the agency; and

5.1.3.8 Reviewing policies and procedures at least annually and reporting, in writing, to the governing body on the review.

5.1.4 The director shall designate, in writing, a similarly qualified person to act in the absence of the director.

5.2 Supervision of Services

5.2.1 The director shall appoint a full-time employee as the clinical director.

5.2.2 The clinical director shall be responsible for implementing, coordinating and assuring quality of patient care services.

5.2.3 The clinical director shall:

5.2.3.1 Be available at all times during operating hours of the home health agency;

5.2.3.2 Participate in all activities related to the services provided, including the qualifications of personnel and contractors as related to their assigned duties; and

5.2.3.3 Provide general supervision and direction of the services offered by the home health agency.

5.2.4 In the absence of the clinical director, an equally qualified designee must be appointed.

5.3 Contract Services

5.3.1 The home health agency maintains responsibility for all services provided to the patient.

5.3.2 Services provided by the home health agency through arrangements with a contractor agency shall be set forth in a written contract which clearly specifies:

5.3.2.1 That the patient’s contract for care is with the home health agency;

5.3.2.2 The services to be provided by the contractor;

5.3.2.3 The necessity to conform to all home health agency policies;

5.3.2.4 The procedure for recording services delivered and scheduling of visits;

5.3.2.5 The procedure for annual assurance of competence of all individuals utilized under contract;

5.3.2.6 The procedure for supervision of services of the contracted individuals;

5.3.2.7 That all payments by the patient for services rendered shall be made directly to the agency or its billing representative and no payments shall be made to or in the name of contractors of the agency;

5.3.2.8 That patients are accepted only by the home health agency. Patients may not be admitted for home health aide services by a contracted individual without prior review of the case and acceptance of the patient by the home health agency in accordance with agency policies; and

5.3.2.9 That the written contractual arrangement must contain a renewal clause or be renewed annually.

5.3.3 The agency must ensure that personnel and services contracted meet the requirements specified in these regulations for home health agency personnel and services.

5.4 Written Policies

5.4.1 Policy manuals shall be prepared which outline the procedures and practices to be followed by employees/contractors of the agency.

5.4.2 The home health agency shall establish written policies regarding:

5.4.2.1 The rights and responsibilities of patients;

5.4.2.2 The handling and documentation of incidents, accidents and medical emergencies;

5.4.2.2.1 Reports of these events shall be kept on file at the agency.

5.4.2.3 Control of the exposure of patients and staff to persons with communicable diseases;

5.4.2.4 Reporting of all reportable communicable diseases to the Department;

5.4.2.5 The patient’s (and family or representative, if any) right to have concerns addressed without fear of reprisal. This policy must include the mechanism for informing the patient of her/his right to report concerns/complaints to the Department at a telephone number established for that purpose.

5.4.2.6 The procedure to be followed in the event that the home health agency is not able to provide services scheduled for any particular day or time. This policy shall include at a minimum:

5.4.2.6.1 The procedure for contacting the patient prior to the missed visit;

5.4.2.6.2 The procedure for attempts to find a substitute home health aide; and

5.4.2.6.3 Documentation of the missed visit and patient contact.

5.4.2.7 Infection control.

5.4.2.8 Employment/Personnel which shall include:

5.4.2.8.1 Qualifications, responsibilities and requirements for each job classification;

5.4.2.8.2 Pre-employment requirements;

5.4.2.8.3 Position descriptions;

5.4.2.8.4 Orientation for all employees and contractors;

5.4.2.8.5 Inservice education;

5.4.2.8.6 Annual performance review and competency testing; and

5.4.2.8.7 The process of appointment to the professional staff whereby it can satisfactorily be determined that the individual is appropriately licensed and qualified for the privileges and responsibilities to be given.

5.4.2.9 Referrals received, admission of patients to agency services, delivery of those services and discharge of patients.

5.4.2.10 The use and removal of records and the conditions for release of information in accordance with statutory provisions pertaining to confidentiality.

5.4.3 The home health agency shall review its written policies at least annually and revise them as necessary.

5.4.4 Policies shall be made available to representatives of the Department upon request.

5.5 Personnel Records

5.5.1 Records of each home health aide shall be kept current and available upon request by authorized representatives of the Department.

5.5.2 For individuals utilized via contract with another agency, the home health agency shall obtain, upon request, any records as required by the Department.

5.5.3 For all individuals, the agency shall maintain individual personnel records which shall contain at least:

5.5.3.1 Written verification of compliance with pre-employment requirements;

5.5.3.2 Documentation of competence;

5.5.3.3 Evidence of current professional licensure, registration or certification as appropriate;

5.5.3.4 Educational preparation and work history;

5.5.3.5 Written performance evaluations (annually); and

5.5.3.6 A written and signed job description.

5.6 Health History

5.6.1 All new employees/contractors shall be required to have a physical examination prior to providing care:

5.6.1.1 The physical examination must have been completed within 12 months prior to employment/referral and

5.6.1.2 A copy of the physical examination shall be maintained in individual files.

5.6.2 Minimum requirements for tuberculosis (TB) testing are those currently recommended by the Centers for Disease Control and Prevention of the U.S. Department of Health and Human Services:

5.6.2.1 A baseline testing must be completed upon hire and, thereafter, as determined by a TB risk assessment.

5.6.2.2 No person found to have active TB in an infectious stage shall be permitted to give care or service to patients.

5.6.2.3 Any person having a positive skin test but a negative chest X-ray must complete a statement annually attesting that they have experienced no symptoms which may indicate active TB infection.

5.6.2.4 A report of all TB test results and all attestation statements shall be on file at the home health agency.

5.6.3 Any individual who cannot adequately perform the duties required or who may jeopardize the health or safety of the patient or patients shall be relieved of their duties and removed from the agency until such time as the condition is resolved. This includes infections of a temporary nature.

5.7 Staff Development

5.7.1 Staff development must be supervised by a registered nurse with at least 1 year of home health and administrative/supervisory experience.

5.7.2 All employees/contractors are required to complete an orientation program.

5.7.3 An orientation/training program should be based on an instruction plan that includes learning objectives, clinical content and minimum acceptable performance standards and shall include but not be limited to:

5.7.3.1 Organizational structure of the agency;

5.7.3.2 Agency patient care policies and procedures;

5.7.3.3 Philosophy of patient care;

5.7.3.4 Description of patient population and geographic location served;

5.7.3.5 Patient rights;

5.7.3.6 Agency personnel and administrative policies;

5.7.3.7 Job description;

5.7.3.8 Disaster Preparedness; and

5.7.3.9 Applicable state regulations governing the delivery of home health care services.

5.7.4 All newly hired/contracted aides shall be required to complete or show evidence of having completed a minimum of 75 hours of training which shall include instruction and supervised practicum and which addresses:

5.7.4.1 Personal care services;

5.7.4.2 Principles of good nutrition;

5.7.4.3 Process of growth, development and aging;

5.7.4.4 Principles of infection control;

5.7.4.5 Observation, reporting and documentation of patient status;

5.7.4.6 Maintaining a clean, safe and healthy environment;

5.7.4.7 Maintaining a least restrictive environment;

5.7.4.8 Verbal/non-verbal communication skills;

5.7.4.9 Reading and recording temperature, pulse and respiration;

5.7.4.10 Safe transfer techniques and ambulation;

5.7.4.11 Normal range of motion and positioning;

5.7.4.12 Introduction to common assistive technology;

5.7.4.13 Principles of body mechanics; and

5.7.4.14 The needs of the elderly and persons with disabilities.

5.7.5 Aides who experience a break in service for greater than 2 calendar years will be required to:

5.7.5.1 Repeat the minimum 75-hour training requirement; or

5.7.5.2 Successfully demonstrate competence in each of the required training areas.

5.7.6 Ongoing staff development is required to maintain and improve the skills of the home health aide. Aides shall attend at least 12 hours annually of staff development activities which shall consist of in-service training programs, workshops or conferences related to home health care or specific needs of patients and which shall include but not be limited to:

5.7.6.1 Instruction in how to assist patients to achieve maximum self-reliance through re-learning and modifying activities of daily living;

5.7.6.2 Principles of good nutrition;

5.7.6.3 Meal planning, food purchasing and preparation of meals, including special diets;

5.7.6.4 Information on the emotional and physical problems accompanying illness, disability or aging;

5.7.6.5 Principles and practices in maintaining a clean, healthy, pleasant and safe environment that encourages morale building and self-help;

5.7.6.6 Items requiring referral to the clinical director, including changes in the patient's condition or family situation;

5.7.6.7 Observation, reporting and documentation of patient status;

5.7.6.8 Policies and objectives of the agency;

5.7.6.9 Confidentiality of patient information;

5.7.6.10 Patient rights;

5.7.6.11 Principles of infection control;

5.7.6.12 Verbal/non-verbal communication skills; and

5.7.6.13 Principles of body mechanics.

5.7.6.14 Dementia specific training that includes: communicating with persons diagnosed as having Alzheimer’s disease or other forms of dementia; the psychological, social, and physical needs of those persons; and safety measures which need to be taken with those persons.

5.7.7 Documentation of orientation and continuing education must be in each individual’s personnel record and must include the date(s) and hour(s), content, and name and title of the person providing the orientation/education.

5.7.8 It is the responsibility of the home health agency to ensure that employees/contractors are proficient to carry out the care assigned in a safe, effective, and efficient manner.

5.7.9 All employees and contractors must pass a competency evaluation test prior to providing care to patients and annually thereafter.

5.7.10 The time allotted for training shall be sufficient to foster safe and skillful services to the patient.

5.7.11 Attendance records must be kept for all orientation and continuing education programs.

**History**
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *27 DE Reg. 45 (07/01/23)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *12 DE Reg. 1209 (03/01/09)*
- *15 DE Reg. 220 (08/01/11)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *27 DE Reg. 45 (07/01/23)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *27 DE Reg. 45 (07/01/23)*
- *12 DE Reg. 1209 (03/01/09)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *12 DE Reg. 1209 (03/01/09)*
- *25 DE Reg. 521 (11/01/21)*
- *25 DE Reg. 521 (11/01/21)*
- *25 DE Reg. 774 (02/01/22)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *25 DE Reg. 774 (02/01/22)*
- *27 DE Reg. 45 (07/01/23)*

##### **16 Del. Admin. Code § 3351-6.0** Patient Care Management {#sec-3351-6.0 omnilex-key=us-de-regs-official--title-16--3351-6.0}

6.1 Admission

6.1.1 The admission policies shall be discussed with each patient entering the program or her/his representative, if applicable.

6.1.2 The home health agency shall only admit those individuals whose needs can be met by the agency.

6.1.3 There shall be a written agreement between the patient and the home health agency. The agreement shall:

6.1.3.1 Specify the services to be provided by the agency, including but not limited to: frequency of visits including hours per day or week, and days per week, transportation agreements as appropriate, emergency procedures and conditions for discharge and appeal.

6.1.3.2 Specify the procedure to be followed when the agency is not able to keep a scheduled patient visit.

6.1.3.3 Specify financial arrangements which shall minimally include:

6.1.3.3.1 A description of services purchased and the associated cost;

6.1.3.3.2 An acceptable method of payment(s) for these services;

6.1.3.3.3 An outline of the billing procedures; and

6.1.3.3.4 That all payments by the patient for services rendered shall be made directly to the agency or its billing representative and no payments shall be made to or in the name of individual employees/contractors of the agency.

6.1.3.4 Be signed by the patient, if (s)he is able, or a representative, if any, and the representative of the home health agency.

6.1.3.5 Be given to the patient and representative, if any, and a copy shall be kept at the agency in the patient record.

6.1.3.6 Be reviewed and updated as necessary to reflect any change in the services or the financial arrangements.

6.2 Assessment

6.2.1 All assessments of the patient must be performed by a registered nurse.

6.2.2 Prior to the provision of services, at a minimum, the initial assessment must include evidence of the following:

6.2.2.1 Physical condition, including ability to perform activities of daily living and sensory limitations;

6.2.2.2 Social situation, including living arrangements and the availability of family and community support;

6.2.2.3 Mental status, including any cognitive impairment and known psychiatric, emotional, and behavioral problems; and

6.2.2.4 Current medication regimen.

6.2.2.5 A visit to the patient’s residence to determine whether the agency has the ability to provide the necessary services in a safe manner.

6.2.3 Reassessments must include, at a minimum, a description of the patient’s:

6.2.3.1 Physical condition, including ability to perform activities of daily living and sensory limitations;

6.2.3.2 Social situation, including living arrangements and the availability of family and community support;

6.2.3.3 Mental status, including any cognitive impairment and known psychiatric, emotional, and behavioral problems; and

6.2.3.4 Current medication regimen.

6.2.4 Patient reassessments and monitoring occur at regular intervals based upon the patient’s condition and needs, but no less often than every 60 calendar days.

6.2.4.1 Every other patient reassessment must be completed in person.

6.2.4.2 Patient reassessments not completed in person must be completed by a telehealth mechanism.

6.2.5 A reassessment shall be conducted when the needs of the patient change which indicate a revision to the home health aide care plan is needed.

6.2.6 The initial assessment and reassessments shall become a permanent part of the patient’s record.

6.3 Home Health Aide Care Plan

6.3.1 The home health agency must provide services in accordance with a written plan of care established by the registered nurse.

6.3.2 A plan of care is developed on admission based upon the initial assessment of the patient.

6.3.3 The patient plan of care shall include reference to at least the following:

6.3.3.1 Types of aide services, scope of services, frequency and duration of services to be provided, including any diet, procedures and transportation required;

6.3.3.2 Functional limitations of the patient;

6.3.3.3 Activities permitted; and

6.3.3.4 Safety measures required to protect the patient from injury.

6.3.4 The plan of care must be reviewed by the registered nurse at least every 60 calendar days.

6.3.5 The home health agency shall consider benefits versus risks of care as well as patient choice and independence in the development and subsequent revisions of the plan of care.

6.3.6 A copy of the plan of care is kept at the patient’s residence; the original is kept in the patient’s record at the agency.

6.4 Scope of Services

6.4.1 Competent patients who do not reside in a medical facility or a facility regulated pursuant to 16 Del.C. Ch. 11 may delegate personal care services to home health aides provided:

6.4.1.1 The nature of the service/task is not excluded by law or other state or federal regulation;

6.4.1.2 The services/tasks are those competent patients could normally perform themselves but for functional limitation; and

6.4.1.3 The delegation decision is entirely voluntary.

6.4.2 Services provided to patients who are not able to delegate services/tasks due to impaired cognitive function shall be those delegated by the registered nurse as permitted by law.

6.4.3 Services are provided under the supervision and direction of the registered nurse.

6.4.3.1 On-site professional supervisory visits are required for all patients receiving home health aide services.

6.4.3.1.1 The registered nurse must make an on-site supervisory visit to the patient’s residence (while the home health aide is providing care) no less frequently than every 60 calendar days.

6.4.3.1.1.1 Every other supervisory visit must be completed in person.

6.4.3.1.1.2 Supervisory visits not completed in person must be completed by a telehealth mechanism.

6.4.3.1.2 A report of the supervisory visit should be kept with the patient’s record.

6.5 Records and Reports

6.5.1 There shall be a separate record maintained at the home health agency for each patient, in accordance with accepted standards, which shall contain:

6.5.1.1 Admission record including patient’s:

6.5.1.1.1 Name;

6.5.1.1.2 Birth date;

6.5.1.1.3 Home address;

6.5.1.1.4 Telephone number; and

6.5.1.1.5 Date of admission.

6.5.1.2 Assessment (initial and reassessments) including but not limited to:

6.5.1.3 Home health aide care plan.

6.5.1.4 A copy of the written agreement between the patient and the home health agency including any updates made to the original reflecting changes in services or arrangements.

6.5.1.5 Written acknowledgment that the patient or the patient’s representative has been fully informed of the patient’s rights.

6.5.1.6 Aide notes which must contain the following information:

6.5.1.6.1 Date(s) on which service(s) are provided;

6.5.1.6.2 Hour(s) of service(s) provided;

6.5.1.6.3 Type(s) of service(s) provided; and

6.5.1.6.4 Observations/problems/comments.

6.5.1.7 A discharge statement.

6.5.1.8 Names, addresses and telephone numbers of family members, friends or other designated people to be contacted in the event of illness or an emergency.

6.5.2 All notes written in the patient’s record must be signed and dated or authenticated on the day that the service is rendered.

6.5.3 All notes and reports in the patient’s record shall be electronic or legibly written in ink, dated and signed by the recording person with her/his full name and title.

6.5.4 Original notes must be incorporated into the patient’s record located at the agency no less often than every 30 days.

6.5.5 All patient records shall be available at all times for review by authorized representatives of the Department and to legally authorized persons; otherwise patient records shall be held confidential. The written consent of the patient or her/his representative, if the patient is incapable of making decisions, shall be obtained before any personal information is released from her/his records as authorized by these regulations or Delaware law.

6.5.6 Computerized patient records must be printed by the agency as requested by authorized representatives of the Department.

6.5.7 The agency must develop acceptable policies for authentication of any computerized records.

6.5.8 The home health agency records shall be retained in a retrievable form until destroyed.

6.5.8.1 Records of adults (18 years of age and older) shall be retained for a minimum of 6 years after the last date of service before being destroyed.

6.5.8.2 Records of minors (less than 18 years of age) shall be retained for a minimum of 6 years after the patient reaches 18 years of age.

6.5.8.3 All records must be disposed of by shredding, burning, or other similar protective measure in order to preserve the patients’ rights of confidentiality.

6.5.8.4 Documentation of record destruction must be maintained by the home health agency.

6.5.8.5 At least 30 calendar days before the agency discontinues operations, it must inform the Department where patient records will be maintained.

6.5.9 Records shall be protected from loss, damage, and unauthorized use.

6.5.10 Report of Major Adverse Incidents

6.5.10.1 The home health agency must report all major adverse incidents, occurring in the presence of a home health home health aide, involving a patient to the Department within 48 hours in addition to other reporting requirements required by law.

6.5.10.2 A major adverse incident includes but is not limited to:

6.5.10.2.1 Suspected abuse, neglect, mistreatment, financial exploitation, solicitation or harassment;

6.5.10.2.2 An accident that causes serious injury to a patient; and

6.5.10.2.3 The unexpected death of a patient.

6.5.10.3 Major adverse incidents must be investigated by the agency.

6.5.10.4 A complete report will be forwarded to the Department within 30 calendar days of occurrence or of the date that the agency first became aware of the incident.

6.6 Discharge

6.6.1 The patient or her/his representative if any, shall be informed of and participate in discharge planning.

6.6.2 The home health agency shall develop a written plan of discharge which includes a summary of services provided and outlines the services needed by the patient upon discharge.

6.6.3 When discharging a patient who does not wish to be discharged, a minimum of 2 weeks notice will be provided to permit the patient to obtain an alternate service provider. Exceptions to the 2 week notice provision would include:

6.6.3.1 The discharge of patients when care goals have been met.

6.6.3.2 The discharge of patients when care needs undergo a change which necessitates transfer to a higher level of care.

6.6.3.3 The discharge of patients when there is documented non-compliance with the plan of care or the admission agreement (including, but not limited to, non-payment of justified charges).

6.6.3.4 The discharge of patients when activities or circumstances in the home jeopardize the welfare and safety of the home health aide.

**History**
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *27 DE Reg. 45 (07/01/23)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *12 DE Reg. 1209 (03/01/09)*
- *15 DE Reg. 220 (08/01/11)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *27 DE Reg. 45 (07/01/23)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *27 DE Reg. 45 (07/01/23)*
- *12 DE Reg. 1209 (03/01/09)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *12 DE Reg. 1209 (03/01/09)*
- *25 DE Reg. 521 (11/01/21)*
- *25 DE Reg. 521 (11/01/21)*
- *25 DE Reg. 774 (02/01/22)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *25 DE Reg. 774 (02/01/22)*
- *27 DE Reg. 45 (07/01/23)*

##### **16 Del. Admin. Code § 3351-7.0** Patient Rights {#sec-3351-7.0 omnilex-key=us-de-regs-official--title-16--3351-7.0}

7.1 The home health agency must provide the patient with a written notice of the patient’s rights during the initial assessment visit or before initiation of care.

7.2 Each patient shall have the right to:

7.2.1 Be treated with courtesy, consideration, respect, and dignity;

7.2.2 Be encouraged and supported in maintaining one’s independence to the extent that conditions and circumstances permit, and to be involved in a program of services designed to promote personal independence;

7.2.3 Self-determination and choice, including the opportunity to participate in developing one’s plan of care;

7.2.4 Privacy and confidentiality;

7.2.5 Be protected from abuse, neglect, mistreatment, financial exploitation, solicitation and harassment;

7.2.6 Voice grievances without discrimination or reprisal;

7.2.7 Be fully informed, as evidenced by the patient’s written acknowledgment of these rights, and of all rules and regulations regarding patient conduct and responsibilities;

7.2.8 Be fully informed, at the time of admission into the program, of services and activities available and related charges;

7.2.9 Be served by individuals who are properly trained and competent to perform their duties; and

7.2.10 Refuse care and to be informed of possible health consequences of the refusal.

7.3 The agency must establish a process for the prompt resolution of grievances, which must include:

7.3.1 The procedure for the submission of a written or verbal grievance;

7.3.2 The timeframes for review of the grievance and the provision of a response; and

7.3.3 A written notice of the decision to the patient/representative that contains the name of the agency contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion.

**History**
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *27 DE Reg. 45 (07/01/23)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *12 DE Reg. 1209 (03/01/09)*
- *15 DE Reg. 220 (08/01/11)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *27 DE Reg. 45 (07/01/23)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *27 DE Reg. 45 (07/01/23)*
- *12 DE Reg. 1209 (03/01/09)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *12 DE Reg. 1209 (03/01/09)*
- *25 DE Reg. 521 (11/01/21)*
- *25 DE Reg. 521 (11/01/21)*
- *25 DE Reg. 774 (02/01/22)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *25 DE Reg. 774 (02/01/22)*
- *27 DE Reg. 45 (07/01/23)*

##### **16 Del. Admin. Code § 3351-8.0** Quality Improvement {#sec-3351-8.0 omnilex-key=us-de-regs-official--title-16--3351-8.0}

8.1 Each home health agency shall develop and implement a documented ongoing quality improvement program. The program shall include at a minimum:

8.1.1 An internal monitoring process that tracks performance measures;

8.1.2 A review of the program’s goals and objectives at least annually;

8.1.3 A review of the grievance/complaint process;

8.1.4 A review of all unexpected patient deaths;

8.1.5 A review of actions taken to address identified issues; and

8.1.6 A process to monitor the satisfaction of the patients or their representatives with the program.

**History**
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *27 DE Reg. 45 (07/01/23)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *12 DE Reg. 1209 (03/01/09)*
- *15 DE Reg. 220 (08/01/11)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *27 DE Reg. 45 (07/01/23)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *27 DE Reg. 45 (07/01/23)*
- *12 DE Reg. 1209 (03/01/09)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *12 DE Reg. 1209 (03/01/09)*
- *25 DE Reg. 521 (11/01/21)*
- *25 DE Reg. 521 (11/01/21)*
- *25 DE Reg. 774 (02/01/22)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *25 DE Reg. 774 (02/01/22)*
- *27 DE Reg. 45 (07/01/23)*

##### **16 Del. Admin. Code § 3351-9.0** Insurance {#sec-3351-9.0 omnilex-key=us-de-regs-official--title-16--3351-9.0}

The home health agency shall have appropriate insurance coverage in force to compensate patients for injuries and losses resulting from services provided by the agency.

**History**
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *27 DE Reg. 45 (07/01/23)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *12 DE Reg. 1209 (03/01/09)*
- *15 DE Reg. 220 (08/01/11)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *27 DE Reg. 45 (07/01/23)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *27 DE Reg. 45 (07/01/23)*
- *12 DE Reg. 1209 (03/01/09)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *12 DE Reg. 1209 (03/01/09)*
- *25 DE Reg. 521 (11/01/21)*
- *25 DE Reg. 521 (11/01/21)*
- *25 DE Reg. 774 (02/01/22)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *25 DE Reg. 774 (02/01/22)*
- *27 DE Reg. 45 (07/01/23)*

##### **16 Del. Admin. Code § 3351-10.0** Disaster Preparedness {#sec-3351-10.0 omnilex-key=us-de-regs-official--title-16--3351-10.0}

10.1 Each home health agency shall prepare and maintain a comprehensive emergency management plan that is consistent with the national standards (i.e., FEMA, ASPR, TRACIE) and consistent with the local and state plans.

10.2 The plan shall:

10.2.1 Provide for continuing home health services during an emergency that interrupts patient care or services in the patient's home; and

10.2.2 Describe how the home health agency establishes and maintains an effective response to emergencies and disasters, including:

10.2.2.1 Notification of staff when emergency response measures are initiated;

10.2.2.2 Provision for communication with and between staff members, local emergency management agencies, the state emergency management agency and patients;

10.2.2.3 Provision for a backup system;

10.2.2.4 Identification of resources necessary to continue essential care and services; and

10.2.2.5 Prioritization of patient care needs and services.

10.3 All agency staff must be oriented to the disaster preparedness plan. Records of staff attendance must be maintained.

10.4 A copy of the disaster preparedness plan shall be available to all staff.

10.5 Each home health agency shall inform patients and patients’ representative, upon admission, of the agency’s procedures during and immediately following an emergency.

**History**
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *27 DE Reg. 45 (07/01/23)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *12 DE Reg. 1209 (03/01/09)*
- *15 DE Reg. 220 (08/01/11)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *27 DE Reg. 45 (07/01/23)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *27 DE Reg. 45 (07/01/23)*
- *12 DE Reg. 1209 (03/01/09)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *12 DE Reg. 1209 (03/01/09)*
- *25 DE Reg. 521 (11/01/21)*
- *25 DE Reg. 521 (11/01/21)*
- *25 DE Reg. 774 (02/01/22)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *25 DE Reg. 774 (02/01/22)*
- *27 DE Reg. 45 (07/01/23)*

##### **16 Del. Admin. Code § 3351-11.0** Infection Control {#sec-3351-11.0 omnilex-key=us-de-regs-official--title-16--3351-11.0}

11.1 The Agency shall establish an infection prevention and control program which shall be based upon Centers for Disease Control and Prevention and other nationally recognized infection prevention and control guidelines. The infection prevention and control program must include all services offered by the Agency, including the appropriate personal protective equipment for all patients and staff.

11.2 The individual designated to lead the Agency’s infection prevention and control program must develop and implement a comprehensive plan that includes actions to prevent, identify and manage infections and communicable diseases. The plan must include mechanisms that result in immediate action to take preventive or corrective measures that improve the Agency’s infection control outcomes.

11.3 All Agency staff shall receive orientation at the time of employment and annual in-service education regarding the infection prevention and control program.

11.4 Specific Requirements for COVID-19

11.4.1 Before their start date, all new staff, vendors, and volunteers must be tested for COVID-19 in accordance with Division of Public Health guidance.

11.4.2 All staff, vendors, and volunteers must be tested for COVID-19 in a manner consistent with Division of Public Health guidance.

11.4.3 The agency must follow recommendations of the Centers for Disease Control and Prevention and the Division of Public Health regarding the provision of care or services to patients by staff, vendor or volunteer found to be positive for COVID-19 in an infectious stage.

11.5 The agency shall amend their policies and procedures to include:

11.5.1 Work exclusion and return to work protocols for staff tested positive for COVID-19;

11.5.2 Staff refusals to participate in COVID-19 testing;

11.5.3 Staff refusals to authorize release of testing results or vaccination status to the agency;

11.5.4 Procedures to obtain staff authorizations for release of laboratory test results to the agency to inform infection control and prevention strategies; and

11.5.5 Plans to address staffing shortages and agency demands should a COVID-19 outbreak occur.

**History**
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *27 DE Reg. 45 (07/01/23)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *12 DE Reg. 1209 (03/01/09)*
- *15 DE Reg. 220 (08/01/11)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *27 DE Reg. 45 (07/01/23)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *27 DE Reg. 45 (07/01/23)*
- *12 DE Reg. 1209 (03/01/09)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *12 DE Reg. 1209 (03/01/09)*
- *25 DE Reg. 521 (11/01/21)*
- *25 DE Reg. 521 (11/01/21)*
- *25 DE Reg. 774 (02/01/22)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *25 DE Reg. 774 (02/01/22)*
- *27 DE Reg. 45 (07/01/23)*

##### **16 Del. Admin. Code § 3351-12.0** Severability {#sec-3351-12.0 omnilex-key=us-de-regs-official--title-16--3351-12.0}

In the event any particular clause or section of these regulations should be declared invalid or unconstitutional by any court of competent jurisdiction, the remaining portions shall remain in full force and effect.

**History**
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *27 DE Reg. 45 (07/01/23)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *12 DE Reg. 1209 (03/01/09)*
- *15 DE Reg. 220 (08/01/11)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *27 DE Reg. 45 (07/01/23)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *27 DE Reg. 45 (07/01/23)*
- *12 DE Reg. 1209 (03/01/09)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *25 DE Reg. 521 (11/01/21)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *12 DE Reg. 1209 (03/01/09)*
- *25 DE Reg. 521 (11/01/21)*
- *25 DE Reg. 521 (11/01/21)*
- *25 DE Reg. 774 (02/01/22)*
- *12 DE Reg. 1209 (03/01/09)*
- *19 DE Reg. 847 (03/01/16)*
- *25 DE Reg. 521 (11/01/21)*
- *25 DE Reg. 774 (02/01/22)*
- *27 DE Reg. 45 (07/01/23)*

#### **3355** Free Standing Surgical Centers

##### **16 Del. Admin. Code § 3355-1.0** Purpose {#sec-3355-1.0 omnilex-key=us-de-regs-official--title-16--3355-1.0}

Delaware Department of Health and Social Services adopts these regulations pursuant to the authority vested by 16 Del.C. §122(3)(p). These regulations establish standards with respect to the operation of free standing surgical centers.

**History**
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *26 DE Reg. 211 (09/01/22)*
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *18 DE Reg. 378 (11/01/14)*
- *25 DE Reg. 627 (12/01/21)*
- *26 DE Reg. 211 (09/01/22)*

##### **16 Del. Admin. Code § 3355-2.0** Definitions {#sec-3355-2.0 omnilex-key=us-de-regs-official--title-16--3355-2.0}

The following words and terms, when used in these regulations, shall have the meanings ascribed to them in this section, except where the context indicates a different meaning:

“Certified Registered Nurse Anesthetist” means an individual currently licensed as an advanced practice nurse pursuant to Title 24, Chapter 19 of the Delaware Code.

“Clinical Director” means a registered nurse, currently licensed to practice nursing pursuant to Title 24, Chapter 19 of the Delaware Code who is sufficiently qualified to provide general supervision and direction of the services offered by the free standing surgical center. The "Clinical Director" and "Director" may be the same individual if that individual is dually qualified.

“Department” means the Delaware Department of Health and Social Services.

“Dentist” means a person currently licensed as a dentist by Title 24, Chapter 11 of the Delaware Code.

“Dietitian” means a person currently licensed as a dietitian by Title 24, Chapter 38 of the Delaware Code.

“Director” means the individual appointed by the governing body to act on its behalf in the overall management of the free standing surgical center. The director shall have: 1) a Baccalaureate Degree; 2) five (5) years healthcare experience; and 3) one (1) year supervisory experience in a surgical setting.

“Free Standing Surgical Center", abbreviated as FSSC, means a facility, other than a hospital or the office of a physician, dentist or podiatrist, or professional association thereof, which is maintained and operated for the purpose of providing surgical services and in which the expected duration of services would not exceed 23 hours 59 minutes following an admission.

“Governing Body” means the individual, group or corporation appointed, elected, or otherwise designated, in which the ultimate responsibility and authority for the conduct of the FSSC is vested.

“Healthcare Professional” means a person currently licensed as a physician, dentist, podiatrist, licensed independent practitioner or registered nurse.

“Incident” means a circumstance or occurrence that may be injurious to a patient or that may result in an adverse outcome to the patient.

“Licensed Independent Practitioner” means a person currently licensed as an advanced practice nurse pursuant to Title 24, Chapter 17 of the Delaware Code, or a person currently licensed as a physician’s assistant pursuant to Title 24, Chapter 19 of the Delaware Code.

“Modification of Ownership and Control” means a change of ownership or transfer of responsibility for the FSSC’s operation.

“Patient” means a person who receives health care services from a FSSC.

“Physician” means a person currently licensed as a physician by Title 24, Chapter 17 of the Delaware Code.

“Plan of Correction” means a written document that includes specific measures to correct identified problems or areas of concern; identifies strategies for implementing system improvements; and includes outcome measures to indicate the effectiveness of system improvements in reducing, controlling or eliminating identified problem areas.

“Podiatrist” means a person currently licensed as a podiatrist by Title 24, Chapter 5 of the Delaware Code.

“Registered Nurse” means a person currently licensed as a registered nurse pursuant to Title 24, Chapter 19 of the Delaware Code.

“Serious Injury” means physical injury that creates a substantial risk of death, or that causes serious disfigurement, serious impairment of health or serious loss or impairment of the function of any bodily organ.

“Surgery” means a procedure performed for the purpose of structurally altering the human body by the incision or destruction of tissues and is part of the practice of medicine. Surgery also is the diagnostic or therapeutic treatment of conditions or disease processes by any instruments causing localized alteration or transposition of live human tissue which include lasers, ultrasound, ionizing radiation, scalpels, probes and needles. The tissue can be cut, burned, vaporized, frozen, sutured, probed, or manipulated by closed reductions for major dislocations or fractures, or otherwise altered by mechanical, thermal, light-based, electromagnetic or chemical means. Injection of diagnostic or therapeutic substances into body cavities, internal organs, joints, sensory organs, and the central nervous system, is also considered to be surgery. The term surgery as used in these Regulations does not include the administration by nursing personnel of some injections – subcutaneous, intramuscular, or intravenous – when ordered by a physician. All of these surgical procedures are invasive, including those that are performed with lasers, and the risks of any surgical procedure are not eliminated by using a light knife or laser in place of a metal knife, or scalpel.

**History**
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *26 DE Reg. 211 (09/01/22)*
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *18 DE Reg. 378 (11/01/14)*
- *25 DE Reg. 627 (12/01/21)*
- *26 DE Reg. 211 (09/01/22)*

##### **16 Del. Admin. Code § 3355-3.0** Licensure Requirements and Procedures {#sec-3355-3.0 omnilex-key=us-de-regs-official--title-16--3355-3.0}

3.1 General requirements

3.1.1 No person shall establish, conduct or maintain in this State any FSSC without first obtaining a license from the Department.

3.1.2 A license issued hereunder shall be subject, at any time, to revision or revocation by the State.

3.1.3 A license is not transferable from person to person, entity to entity or from one location to another.

3.1.4 The license shall be posted in a conspicuous place on the licensed premises, at or near the entrance in a manner which is plainly visible and easily read by the public.

3.1.5 Each license shall be issued for a specific number and class of operating rooms along with the specific number of pre-operative and post-anesthesia recovery beds to support them. The number of admitted patients shall not exceed the total number of licensed beds.

3.1.6 Separate licenses are required for FSSCs maintained in separate locations, even though operated under the same management.

3.1.7 Any FSSC that undergoes a modification of ownership and control is required to re-apply as a new FSSC and must meet the current design and construction standards recognized by the Department.

3.1.8 Licenses will be issued for specific hours of operation and FSSCs may not operate beyond those hours for which it is licensed.

3.1.9 The submission of an application form is in no way a guarantee that the completed application will be accepted or that a license will be issued by the Department.

3.1.10 Patients shall not be admitted to a FSSC until a license has been issued.

3.2 Application process

3.2.1 All persons or entities wanting to apply to open a FSSC shall submit to the Department the following information:

3.2.1.1 A Statement of Intent describing the services to be offered by the FSSC;

3.2.1.2 A completed application for licensure;

3.2.1.3 The names, addresses and types of facilities previously and currently owned or managed by the applicant;

3.2.1.4 Identity of:

3.2.1.4.1 Each officer and director of the corporation, if the entity is organized as a corporation;

3.2.1.4.2 Each general partner or managing member, if the entity is organized as an unincorporated entity;

3.2.1.4.3 The governing body; and

3.2.1.4.4 Any officers/directors, partners, or managing members, or members of a governing body who have a financial interest in a licensee’s operation or related businesses.

3.2.1.5 Proof of not-for-profit status, if claiming tax-exempt status;

3.2.1.6 Disclosure of any officer, director, partner, employee, managing member or member of the governing body with a felony criminal record;

3.2.1.7 Name of the director and the person designated to act in the absence of the director;

3.2.1.8 A list of management personnel, including credentials;

3.2.1.9 A plan for providing orientation, continuing education, and training for personnel or independent contractors during the first year of operation;

3.2.1.10 Policy and procedure manuals;

3.2.1.11 Applicants wanting to open a FSSC to accommodate patient stays of 23 hours and 59 minutes must have written approval from the local government having jurisdiction certifying that the proposed use will not conflict with any zoning restrictions, deed restrictions and local noise ordinances prior to applying for licensure to the Department; and

3.2.1.12 Any other information required by the Department.

3.2.2 A currently licensed FSSC wishing to change its hours of operation to accommodate patient stays of 23 hours and 59 minutes must request approval in writing from the local government having jurisdiction. Once written approval is received from the local government having jurisdiction, the FSSC may then apply to the Department for approval of the extended hours.

3.3 Issuance of licenses

3.3.1 Initial license:

3.3.1.1 An initial license shall be granted for a period of nine (9) calendar months to every FSSC that completes the application process consistent with these regulations and whose policies and procedures demonstrate compliance with the rules and regulations pertaining to FSSC licensure.

3.3.1.2 An initial license will permit a FSSC to hire or contract with personnel and begin to offer services.

3.3.1.3 All FSSCs shall have an on-site survey, conducted by the Department, during the first nine (9) calendar months of operation.

3.3.1.4 A FSSC, at the time of an initial on-site survey, must meet the definition of a FSSC as contained within these regulations and must be in operation and caring for patients. Facilities that, at the time of an on-site survey, do not meet the definition of a FSSC or that are not in substantial compliance with these regulations will not be granted a license.

3.3.1.5 An initial license may not be renewed.

3.3.2 Provisional license:

3.3.2.1 A provisional license shall be granted, for a period of less than one year, to all FSSCs that:

3.3.2.1.1 Are not in substantial compliance with these rules and regulations; or

3.3.2.1.2 Fail to renew a license within the timeframe prescribed by these regulations.

3.3.2.2 The Department shall designate the conditions and the time period under which a provisional license is issued.

3.3.2.3 A provisional license may not be renewed unless a Plan of Correction for coming into substantial compliance with these rules and regulations has been approved by the Department and implemented by the FSSC.

3.3.2.4 A license will not be granted after the provisional licensure period to any FSSC that is not in substantial compliance with these rules and regulations.

3.3.3 Annual License:

3.3.3.1 An annual license shall be granted, for a period of one year (12 months) to all FSSCs which are, and remain, in substantial compliance with these rules and regulations.

3.3.3.2 An annual license shall be effective for a twelve-month period following date of issue and shall expire one year following such date, unless it is modified to a provisional, suspended, revoked or surrendered prior to the expiration date.

3.3.3.3 FSSCs must reapply for licensure at least 30 days prior to the expiration date of the license.

3.3.3.4 FSSCs which have not been inspected/surveyed during a licensure year may apply for, and be issued, a new license until an inspection/survey is completed.

3.3.3.5 An annual license may not be issued to a FSSC which is not in substantial compliance with these regulations or whose deficient practices present an immediate threat to the health and safety of its patients.

3.4 Modification of ownership and control (MOC)

3.4.1 Any proposed MOC must be reported to the Department a minimum of 30 calendar days prior to the change.

3.4.2 An MOC occurs whenever the ultimate legal authority for the responsibility of the FSSC’s operation is transferred.

3.4.3 An MOC voids the current license in possession of the FSSC.

3.4.4 An MOC will be treated as an initial license and the FSSC must meet the current design and construction standards recognized by the Department.

3.4.5 An MOC may include but is not limited to:

3.4.5.1 Transfer of the FSSC’s legal title;

3.4.5.2 Transfer of full ownership rights;

3.4.5.3 Transfer of the majority interest;

3.4.5.4 Transfer of ownership interests that result in the owner with the majority interest becoming a minority interest owner;

3.4.5.5 Transfer or re-organization that results in an additional majority interest that is equal in ownership rights;

3.4.5.6 Transfer resulting in a measurable impact upon the operational control of the FSSC;

3.4.5.7 Dissolution of any partnership that owns, or owns a controlling interest in the FSSC;

3.4.5.8 Merger of a FSSC owner (a corporation) into another corporation where, after the merger, the owner’s shares of capital stock are canceled; or

3.4.5.9 The consolidation of a corporate FSSC owner with one or more corporations.

3.4.5.10 Any other transfer or action under 8 Del.C. is considered an MOC under these regulations.

3.4.6 Transactions which do not constitute an MOC include, but are not limited to the following:

3.4.6.1 Changes in the membership of a corporate board of directors or board of trustees;

3.4.6.2 Two or more corporations merge and the originally licensed corporation survives;

3.4.6.3 Changes in the membership of a non-profit corporation; or

3.4.6.4 Corporate stock transfers or sales that do not result in a transfer of interest or ownership.

3.4.7 Applications for licensure, as a result of an MOC must include a description of:

3.4.7.1 Any actual or anticipated change in the health care services provided before the MOC;

3.4.7.2 Any actual or anticipated change in staff, including the composition of staff;

3.4.7.3 Any actual or anticipated change in policies and procedures; and

3.4.7.4 Any change in the manner of delivery of health care services.

3.5 Fees. Fees shall be in accordance with 16 Del.C. §122 (3)p.

3.6 Inspection. A representative of the Department shall periodically inspect every FSSC for which a license has been issued under this chapter. Inspections by authorized representatives of the Department may occur at any time and may be scheduled or unannounced.

3.7 Notice to patients. The FSSC shall notify each patient (or the patient's authorized representative) scheduled for an upcoming surgical procedure of the voluntary surrender of its license, or as directed under an order of denial, revocation or suspension of license issued by the Department.

3.8 Exclusions from licensure. The following persons, associations or organizations are not required to obtain a FSSC license:

3.8.1 A FSSC that is directly adjacent to and licensed as part of a hospital; or

3.8.2 A FSSC which is used as an office for the private practice of a physician, podiatrist or dentist.

**History**
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *26 DE Reg. 211 (09/01/22)*
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *18 DE Reg. 378 (11/01/14)*
- *25 DE Reg. 627 (12/01/21)*
- *26 DE Reg. 211 (09/01/22)*

##### **16 Del. Admin. Code § 3355-4.0** General Requirements {#sec-3355-4.0 omnilex-key=us-de-regs-official--title-16--3355-4.0}

4.1 The FSSC shall be in compliance with federal, state and local laws and codes.

4.2 The provisions of 42 CFR Ch. IV, Part 416, Subparts A, B and C, are hereby adopted as the regulatory requirements for FSSCs in Delaware. 42 CFR Ch. IV, Part 416 is hereby referred to, and made part of this Regulation, as if fully set out herein.

4.3 The provisions of the National Fire Protection Association’s Life Safety Code, as adopted and modified by the State Fire Prevention Regulations, are hereby adopted as the regulatory requirements for FSSCs in Delaware and are hereby referred to, and made part of this Regulation, as if fully set out herein.

4.4 The provisions of the Centers for Disease Control and Prevention Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, are hereby adopted as the regulatory requirements for FSSCs in Delaware and are hereby referred to, and made part of this Regulation, as if fully set out herein.

4.5 The provisions of the 2022 Facility Guidelines Institute’s Guidelines for Design and Construction of Health Care Facilities, are hereby adopted as the regulatory requirements for FSSCs in Delaware and are hereby referred to, and made part of this Regulation, as if fully set out herein.

4.5.1 When a FSSC is classified under this law or regulation and plans to construct, extensively remodel or convert any buildings, one (1) copy of properly prepared plans and specifications for the entire FSSC shall be submitted to the Department.

4.5.2 An approval, in writing, shall be obtained from the Department before construction/renovation/remodeling work is begun.

4.5.3 Upon completion of construction/renovation/remodeling, in accordance with the plans and specifications, the Department will inspect and approve the site prior to occupancy/use by the FSSC.

4.5.4 All facilities shall either be at grade level or shall be equipped with ramps or elevators to allow easy access for persons with disabilities.

4.5.5 The FSSC shall comply with all local and state building codes and ordinances as pertain to this occupancy.

4.5.6 Waiver of a standard requires Department approval. Waiver requests must be made in writing, include the full justification behind the request and address issues of safety and infection control. Waivers are an exception to established standards and will only be approved for compelling reason.

4.6 The provisions of the State of Delaware Food Code, 16 DE Admin. Code 4458, are hereby adopted as the regulatory requirements for FSSCs in Delaware and are hereby referred to, and made part of this Regulation, as if fully set out herein.

4.7 The provisions of the State of Delaware, Department of Natural Resources and Environmental Control, Regulations Governing Solid Waste, 7 DE Admin. Code 1301, are hereby adopted as the regulatory requirements for FSSCs in Delaware and are hereby referred to, and made part of this Regulation, as if fully set out herein.

4.8 No policies shall be adopted by the FSSC which are in conflict with these regulations.

4.9 The FSSC shall advise the Department in writing within 15 calendar days following any change in the designation of the director or clinical director within the FSSC.

4.10 The FSSC may contract for services to be provided to its patients. Individuals providing services under contract must meet the same requirements as those persons employed directly by the FSSC.

4.11 The FSSC shall advise the Department in writing at least 30 calendar days prior to closure of the FSSC and voluntary surrender of a license.

4.12 All records maintained by the FSSC shall at all times be open to inspection by authorized representatives of the Department.

4.13 The FSSC must permit photocopying of any records or other information by, or on behalf of authorized representatives of the Department, as necessary to determine or verify compliance with these regulations.

4.14 Reports of incidents, accidents and medical emergencies shall be kept on file at the FSSC for a minimum of five (5) years.

4.15 Report of major adverse incidents

4.15.1 The FSSC must report all major adverse incidents involving a patient to the Department within 48 hours in addition to other reporting requirements required by law.

4.15.2 A major adverse incident includes but is not limited to:

4.15.2.1 Suspected abuse, neglect, mistreatment, financial exploitation, solicitation or harassment of patients;

4.15.2.2 An accident that causes serious injury to a patient;

4.15.2.3 A medication error with the potential to result in adverse health outcomes for the patient;

4.15.2.4 Surgery on the wrong patient or wrong body part; or

4.15.2.5 The unexpected death of a patient.

4.15.3 Major adverse incidents must be investigated by the FSSC.

4.15.4 The FSSC must submit a complete report to the Department within 30 calendar days of the incident.

4.16 For those FSSCs that apply for and receive approval to remain open overnight:

4.16.1 Patients admitted to the FSSC will be permitted to stay 23 hours and 59 minutes, starting from the time of admission.

4.16.2 The time calculation begins when the patient is moved from the waiting room to begin the preparation for surgical services.

4.16.3 This time must be documented in the patient’s medical record.

4.16.4 The discharge occurs when the physician has signed the discharge order and the patient has left the recovery room.

**History**
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *26 DE Reg. 211 (09/01/22)*
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *18 DE Reg. 378 (11/01/14)*
- *25 DE Reg. 627 (12/01/21)*
- *26 DE Reg. 211 (09/01/22)*

##### **16 Del. Admin. Code § 3355-5.0** Governing Body {#sec-3355-5.0 omnilex-key=us-de-regs-official--title-16--3355-5.0}

5.1 Each FSSC shall have an organized governing body (governing authority, owner or person(s) designated by the owner).

5.2 The governing body responsibilities include, but are not limited to:

5.2.1 Appointing a qualified director in writing;

5.2.2 Appointing members of the clinical staff, ensuring their competence and delineating their job responsibilities;

5.2.3 Annual review and evaluation of the FSSC policies and services;

5.2.4 Conducting meetings, when the governing body is more than one person, at least annually and maintaining written minutes of the meetings; and

5.2.5 Adopting governing body and medical staff bylaws for the orderly development and management of the FSSC.

5.2.5.1 Bylaws shall be reviewed annually by the governing body and so dated. Revisions shall be completed as necessary.

5.3 There shall be a description of each type of service offered.

5.4 The governing body shall provide for full disclosure of ownership to the Department.

**History**
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *26 DE Reg. 211 (09/01/22)*
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *18 DE Reg. 378 (11/01/14)*
- *25 DE Reg. 627 (12/01/21)*
- *26 DE Reg. 211 (09/01/22)*

##### **16 Del. Admin. Code § 3355-6.0** Administration/Personnel {#sec-3355-6.0 omnilex-key=us-de-regs-official--title-16--3355-6.0}

6.1 Director

6.1.1 There shall be a full-time FSSC director.

6.1.2 The director shall have the overall authority and responsibility for the daily operation and management of the FSSC.

6.1.3 The authority, duties and responsibilities of the director shall be defined in writing and shall include but not be limited to:

6.1.3.1 Interpretation and execution of the policies adopted by the governing body;

6.1.3.2 Program planning, budgeting, management and program evaluation;

6.1.3.3 Maintenance of the FSSC’s compliance with licensure regulations and standards;

6.1.3.4 Preparation and submission of required reports;

6.1.3.5 Distribution of a written plan for the delegation of administrative responsibilities and functions in the absence of the director;

6.1.3.6 Documentation of complaints relating to the conduct or actions by employees/contractors/medical staff and action taken secondary to the complaints;

6.1.3.7 Conducting or supervising the resolution of complaints received from patients regarding the delivery of care or services; and

6.1.3.8 Reviewing policies and procedures at least annually, and reporting, in writing, to the governing body on the review.

6.1.4 The director shall designate, in writing, a person who meets the director qualifications to act in the absence of the director.

6.2 Supervision of clinical services

6.2.1 The director shall appoint, in writing, a full-time employee as the clinical director.

6.2.2 The clinical director shall be responsible for implementing, coordinating and assuring quality of patient care services.

6.2.3 The clinical director shall:

6.2.3.1 Be a registered nurse with at least one year of surgical and administrative/supervisory experience;

6.2.3.2 Participate in all activities related to the services provided, including the qualifications of personnel and contractors as related to their assigned duties; and

6.2.3.3 Provide general supervision and direction of the services offered by the FSSC.

6.2.4 The director shall designate, in writing, a person who meets the clinical director qualifications to act in the absence of the clinical director.

6.3 Contract services

6.3.1 The FSSC maintains responsibility for all services provided to the patient.

6.3.2 Services provided by the FSSC through arrangements with a contractor agency or individual shall be set forth in a written contract which clearly specifies:

6.3.2.1 The services to be provided by the contractor;

6.3.2.2 The necessity to conform to all FSSC policies;

6.3.2.3 The procedure for annual assurance of clinical competence of all individuals utilized under contract;

6.3.2.4 The procedure for supervision of services of the contracted individuals; and

6.3.2.5 A renewal clause or language that states the contract will be renewed annually.

6.3.3 The FSSC must ensure that personnel and services contracted meet the requirements specified in these regulations for FSSC personnel and services.

6.4 Written policies

6.4.1 Policy manuals shall be prepared and followed which outline the procedures and practices of the FSSC.

6.4.2 The FSSC shall establish written policies which include, but are not limited to:

6.4.2.1 Compliance with state licensure law;

6.4.2.2 Governing body and management;

6.4.2.3 Surgical services;

6.4.2.4 Quality assessment and performance improvement;

6.4.2.5 Environment;

6.4.2.6 Medical staff;

6.4.2.7 Nursing services;

6.4.2.8 Medical records;

6.4.2.9 Pharmaceutical services;

6.4.2.10 Laboratory and radiologic services;

6.4.2.11 Patient rights;

6.4.2.12 Infection control;

6.4.2.13 Patient admission, assessment and discharge;

6.4.2.14 The handling and documentation of incidents, accidents and medical emergencies;

6.4.2.15 The procedure to be followed in the event that the FSSC is not able to provide services scheduled for any particular day or time;

6.4.2.16 Reporting of all reportable communicable diseases to the Department; and

6.4.2.17 Employment/Personnel. Such policies shall include:

6.4.2.17.1 Qualifications, responsibilities and requirements for each job classification;

6.4.2.17.2 Pre-employment requirements;

6.4.2.17.3 Position descriptions;

6.4.2.17.4 Orientation;

6.4.2.17.5 Inservice education;

6.4.2.17.6 Annual performance review and competency testing; and

6.4.2.17.7 The process of appointment to the professional staff whereby it can satisfactorily be determined that the individual is appropriately licensed and qualified for the privileges and responsibilities to be given.

6.4.3 The FSSC shall review its written policies at least annually, and revise them as necessary. Documentation of the annual review must be maintained by the FSSC.

6.4.4 Policies shall be made available to representatives of the Department upon request.

6.5 Personnel records

6.5.1 Records of each employee/contractor shall be available upon request by authorized representatives of the Department.

6.5.2 For all employees/contractors, the FSSC shall maintain current individual personnel records on-site which shall contain at least:

6.5.2.1 Written verification of compliance with pre-employment requirements;

6.5.2.2 Documentation of clinical competence;

6.5.2.3 Evidence of current professional licensure, registration or certification as appropriate;

6.5.2.4 Educational preparation and work history;

6.5.2.5 Written performance evaluations conducted, at least, annually; and

6.5.2.6 A written and signed job description.

6.6 Staff development

6.6.1 All employees/contractors, including medical staff, are required to complete an orientation program.

6.6.2 An orientation/training program should be based on an instruction plan that includes learning objectives, clinical content and minimum acceptable performance standards, and shall include but not be limited to:

6.6.2.1 Organizational structure of the FSSC;

6.6.2.2 Patient care policies and procedures;

6.6.2.3 Infection control;

6.6.2.4 Philosophy of patient care;

6.6.2.5 Patient rights;

6.6.2.6 Personnel and administrative policies;

6.6.2.7 Job description;

6.6.2.8 Disaster preparedness; and

6.6.2.9 Applicable state regulations governing the delivery of services.

6.6.3 Documentation of orientation must include the date and hours, content, and name and title of the person providing the orientation.

6.6.4 It is the responsibility of the FSSC to ensure that employees/contractors are proficient to carry out the assigned care in a safe, effective and efficient manner. Nothing in these regulations is intended to restrict the practice of licensed independent practitioners practicing in accordance with Delaware law.

6.6.5 All newly hired employees and contractors must have a written validation of competency upon orientation, prior to providing care to patients, and annually thereafter.

6.6.6 Attendance records must be kept for all orientation and continuing education programs.

6.7 Medical staff

6.7.1 All persons admitted to the FSSC shall be under the care of a physician.

6.7.2 One (1) or more physicians should be in attendance in the FSSC, or in the case of overnight care, immediately available via electronic communication, at all times during patient treatment and recovery and until patients are medically discharged.

6.7.3 A medical director shall be appointed and shall be responsible for the direction, provision and quality of medical care.

6.7.4 All members of the FSSC’s medical staff must be appointed to their position within the FSSC by the governing body.

6.7.5 Medical staff privileges must be granted by the governing body, in writing, and must specify, in detail, the types of procedures that each physician may perform within the FSSC.

6.7.6 Medical staff privileges must be reappraised by the FSSC at least every 24 months.

6.7.7 If the FSSC assigns patient care responsibilities to licensed independent practitioners other than physicians, it must have:

6.7.7.1 Established credentialing and privileging procedures approved by the governing body; and

6.7.7.2 Policies and procedures, approved by the governing body, for overseeing and evaluating clinical activities.

6.8 Nursing services

6.8.1 Nursing services must be under the direction of a clinical director.

6.8.2 There must be sufficient nursing staff with the appropriate qualifications to assure the nursing needs of all FSSC patients are met.

6.8.3 Patient care responsibilities must be delineated for all nursing service personnel.

6.8.4 Nursing services must be provided in accordance with recognized standards of practice.

6.8.5 A registered nurse, qualified by education and experience in operating room nursing, shall be present as a circulating nurse in each operating room where moderate/deep/general anesthesia/sedation is administered during operative procedures.

6.8.6 Individual patient assignments on a given day must be documented clearly on an assignment sheet which must be kept on file for one (1) year from date of procedure.

**History**
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *26 DE Reg. 211 (09/01/22)*
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *18 DE Reg. 378 (11/01/14)*
- *25 DE Reg. 627 (12/01/21)*
- *26 DE Reg. 211 (09/01/22)*

##### **16 Del. Admin. Code § 3355-7.0** General Patient Care Management {#sec-3355-7.0 omnilex-key=us-de-regs-official--title-16--3355-7.0}

7.1 The admission policies shall be discussed with each patient entering the FSSC or their representative, if applicable.

7.2 The FSSC must develop and maintain a policy that identifies those patients who require a medical history and physical examination prior to surgery. The policy must:

7.2.1 Include the timeframe for medical history and physical examination to be completed prior to surgery.

7.2.2 At a minimum, address the following factors:

7.2.2.1 Patient age;

7.2.2.2 Diagnosis;

7.2.2.3 The type and number of procedures scheduled to be performed on the same surgery date;

7.2.2.4 Known comorbidities;

7.2.2.5 Planned anesthesia level; and

7.2.2.6 Be based on nationally recognized standards of practice and guidelines.

7.3 Upon admission to the FSSC, each patient must have a pre-surgical assessment completed by the physician or licensed independent practitioner. The patient’s medical record must include documentation that the patient was examined prior to the commencement of surgery for changes since the comprehensive medical history and physical assessment.

7.4 Surgical procedures must be performed in a safe manner and in accordance with acceptable standards of practice.

7.5 Before discharge from the FSSC, each patient must be evaluated by a physician or certified registered nurse anesthetist for proper anesthesia recovery. It is expected that a patient will actually leave the FSSC within 15 – 30 minutes of the time when the physician signs the discharge order.

7.6 The FSSC must provide each patient with written discharge instructions and overnight supplies. Patients shall be informed, prior to leaving the FSSC, of their prescriptions, post-operative instructions, and physician contact information for follow-up care. When appropriate, the FSSC shall make a follow-up appointment for the patient with their physician.

7.7 The FSSC shall provide nutritional services for patients as follows:

7.7.1 Assure the availability of meals, beverages and supplemental snacks in accordance with each patient’s individual needs.

7.7.2 Provide or make arrangements for a minimum of one (1) meal which is of suitable quality and quantity for patients who are in the FSSC for six (6) or more hours. The meal shall meet at least 1/3 of an adult’s current recommended dietary allowance (RDA) of the Food and Nutrition Board, National Academy of Sciences-National Research Council.

7.7.3 Provide or make arrangements for a minimum of two (2) meals which are of suitable quality and quantity for patients who are in the FSSC for 12 or more hours. The meals shall meet at least 2/3 of an adult’s current recommended dietary allowance (RDA) of the Food and Nutrition Board, National Academy of Sciences-National Research Council.

7.7.4 Provide therapeutic diets as necessary in accordance with each patient’s individual needs.

7.7.5 Meals prepared on-site must be approved by a dietitian.

7.7.6 All employees/contractors involved in direct patient care shall be trained on basic and special nutritional needs and proper food handling techniques. Training shall be part of the initial orientation and shall be conducted annually thereafter.

7.7.7 Appropriate food containers and utensils shall be available as needed for use by disabled patients.

7.7.8 The provision and consumption of meals and snacks shall be documented in the patient’s medical record.

7.8 There must be healthcare professionals with specialized training or experience in emergency care including current Advance Cardiac Life Support certification, available in the FSSC to provide emergency treatment at all times when patients are present.

**History**
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *26 DE Reg. 211 (09/01/22)*
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *18 DE Reg. 378 (11/01/14)*
- *25 DE Reg. 627 (12/01/21)*
- *26 DE Reg. 211 (09/01/22)*

##### **16 Del. Admin. Code § 3355-8.0** Infection Control {#sec-3355-8.0 omnilex-key=us-de-regs-official--title-16--3355-8.0}

8.1 The FSSC shall establish and implement an infection prevention and control program which shall be based upon nationally recognized infection control guidelines/standards (i.e. CDC, AORN, etc.).

8.2 The FSSC must provide and maintain a functional and sanitary environment for surgical services, to avoid sources and transmission of infections and communicable diseases.

8.3 The FSSC must maintain an ongoing program to prevent, control and investigate infections and communicable diseases. As part of this ongoing program, the FSSC must have an active surveillance component that covers both patients and personnel working in the FSSC. Surveillance includes infection detection through ongoing data collection and analysis.

8.4 The FSSC must designate in writing, a qualified licensed healthcare professional who will lead the FSSC’s infection control program. The FSSC must determine that the individual has had training in the principles and methods of infection control.

8.5 The individual designated to lead the FSSC’s infection control program must develop and implement a comprehensive plan that includes actions to prevent, identify and manage infections and communicable diseases within the FSSC. The plan of action must include mechanisms that result in immediate action to take preventive or corrective measures that improve the FSSC’s infection control outcomes. The plan should be specific to each particular area of the FSSC, including, but not limited to, the waiting room(s), the recovery room(s) and the surgical areas.

8.6 The FSSC’s infection control program must be integrated into its quality improvement program. Infection control data and program activities are an ongoing component of the quality improvement program and actions are taken in response to data analyses to improve the FSSC’s infection control performance.

8.7 Specific Requirements for COVID-19

8.7.1 Before their start date, all new staff, vendors and volunteers must be tested for COVID-19 in accordance with Delaware Division of Public Health Guidance.

8.7.2 All staff, vendors and volunteers must be tested for COVID-19 in a manner consistent with Division of Public Health Guidance.

8.7.3 Facilities must follow recommendations of the Centers for Disease Control and Prevention and the Division of Public Health regarding the provision of care or services to patients by staff, vendor or volunteer found to be positive for COVID-19 in an infectious stage.

8.8 The FSSC shall amend their policies and procedures to include:

8.8.1 Work exclusion and return to work protocols for staff tested positive for COVID-19;

8.8.2 Staff refusals to participate in COVID-19 testing;

8.8.3 Staff refusals to authorize release of testing results or vaccination status to the FSSC;

8.8.4 Procedures to obtain staff authorizations for release of laboratory test results to the facility to inform infection control and prevention strategies; and

8.8.5 Plans to address staffing shortages and facility demands should a COVID-19 outbreak occur.

**History**
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *26 DE Reg. 211 (09/01/22)*
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *18 DE Reg. 378 (11/01/14)*
- *25 DE Reg. 627 (12/01/21)*
- *26 DE Reg. 211 (09/01/22)*

##### **16 Del. Admin. Code § 3355-9.0** Quality/Performance Improvement Program {#sec-3355-9.0 omnilex-key=us-de-regs-official--title-16--3355-9.0}

The FSSC must take a proactive, comprehensive and ongoing approach to improving the quality and safety of the surgical services it delivers.

**History**
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *26 DE Reg. 211 (09/01/22)*
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *18 DE Reg. 378 (11/01/14)*
- *25 DE Reg. 627 (12/01/21)*
- *26 DE Reg. 211 (09/01/22)*

##### **16 Del. Admin. Code § 3355-10.0** Environment {#sec-3355-10.0 omnilex-key=us-de-regs-official--title-16--3355-10.0}

10.1 The FSSC must have a safe and sanitary environment, properly constructed, equipped, and maintained to protect the health and safety of patients.

10.2 Laundry and linens

10.2.1 An adequate supply of clean linen or disposable materials shall be maintained.

10.2.2 Clean linen shall be stored, handled and transported to prevent contamination.

10.2.3 Linens shall be maintained in good repair.

10.2.4 There shall be separate and distinct areas for the storage and handling of clean and soiled linens.

10.2.5 Soiled linen shall be handled, transported, stored and processed in a manner to prevent leakage and the spread of infection.

10.2.6 Soiled linen not processed on a daily basis must be stored in a separate properly ventilated storage area.

10.2.7 Soiled linen must be removed from the operating/procedure room after each procedure.

10.2.8 Carts used to transport soiled linen must be constructed of impervious materials and must be cleaned and disinfected after each use.

10.2.9 Laundry processed on-site:

10.2.9.1 The laundry processing area shall be arranged to allow for an orderly progressive flow of work from the soiled to the clean area.

10.2.9.2 The temperature of water during the washing process shall be controlled to provide a minimum temperature of 165° Fahrenheit for 25 minutes or 130° Fahrenheit if the soap/detergent supplier will verify that their products will work effectively at that lower temperature. A label indicating same shall be affixed to the laundry machine.

10.2.10 Laundry processed off-site:

10.2.10.1 The FSSC must have a contract with a commercial or hospital laundry.

10.2.10.2 Clean linens returned to the FSSC must be completely wrapped or covered to protect against contamination.

10.3 Sanitation and housekeeping

10.3.1 The FSSC shall provide housekeeping services to maintain a clean, sanitary, safe environment which is free from odors.

10.3.2 Operating/procedure rooms shall be thoroughly cleaned after each use.

10.3.3 All cleaning materials, solutions, cleaning compounds and hazardous substances shall be:

10.3.3.1 Properly identified;

10.3.3.2 Stored in a safe place; and

10.3.3.3 Stored separate from patient care items and food.

10.3.4 Cleaning shall be performed in a manner which minimizes the spread of pathogenic organisms in the environment.

10.3.5 The FSSC shall be kept free of insects and rodents. A contract with a pest control agency shall be executed and available for review.

10.4 Waste storage and disposal

10.4.1 All rubbish and refuse containers shall be impervious, lined and clean.

10.4.2 All rubbish and refuse shall be collected, stored and disposed of in a manner designed to prevent transmission of disease.

10.4.3 All contaminated dressings, pathological or similar waste shall be properly disposed of.

10.4.4 All personnel must wash their hands immediately after handling rubbish or refuse.

10.5 Fire safety

10.5.1 The FSSC must be inspected annually by the fire marshal having jurisdiction and all applications for license (new and renewal) must include documentation, dated within the past 12 months, indicating compliance to all applicable fire code regulations.

10.5.2 Failure to provide documentation from the fire marshal having jurisdiction, dated within the past 12 months, indicating compliance to all applicable fire code regulations shall be grounds for licensure action.

10.5.3 All employees shall be trained in procedures to be followed in the event of a fire and emergency. Training shall be part of initial employee orientation and shall be conducted quarterly thereafter.

**History**
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *26 DE Reg. 211 (09/01/22)*
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *18 DE Reg. 378 (11/01/14)*
- *25 DE Reg. 627 (12/01/21)*
- *26 DE Reg. 211 (09/01/22)*

##### **16 Del. Admin. Code § 3355-11.0** Medical Records {#sec-3355-11.0 omnilex-key=us-de-regs-official--title-16--3355-11.0}

11.1 Medical records must include an advance health-care directive form that complies with 16 Del.C. Ch. 25, a statement that a copy of the advance health-care directive form has been requested, or a statement that none has been signed.

11.2 The FSSC must have a documented system that enables it to systematically develop a unique medical record for each patient, permit timely access to the medical record to support the delivery of care, and store records. Records may exist in hard copy, electronic format, or a combination of the two media.

11.3 All entries in the medical record must be signed and dated by the responsible person in accordance with the FSSC's policies and procedures.

11.4 A person knowledgeable in the management of medical records shall be responsible for the proper administration and functioning of the medical records section.

11.5 There shall be an identified locked area for medical record storage at the FSSC.

11.6 Medical records shall be protected from loss, damage and unauthorized use.

11.7 The FSSC shall ensure that each medical record is treated with confidentiality and is maintained according to professional standards of practice.

11.8 The FSSC must develop acceptable policies for authentication of any computerized records.

11.9 All patient records shall be available for review by authorized representatives of the Department and to legally authorized persons; otherwise, patient records shall be held confidential. The consent of the patient or her/his representative, if the patient is incapable of making decisions, shall be obtained before any personal information is released from her/his records as authorized by these regulations and Delaware law.

11.10 Computerized patient records must be printed by the FSSC as requested by authorized representatives of the Department.

11.11 Medical records shall be retained in a retrievable form until destroyed.

11.11.1 Records of adults (18 years of age and older) shall be retained for a minimum of five (5) years after the last date of service before being destroyed.

11.11.2 Records of minors (less than 18 years of age) shall be retained for a minimum of five (5) years after the patient reaches 18 years of age.

11.11.3 All records must be disposed of by shredding, burning or other similar protective measure in order to preserve the patient’s rights of confidentiality.

11.11.4 The FSSC must establish procedures for the notification to patients regarding the pending destruction of medical records.

11.11.5 Documentation of record destruction must be maintained by the FSSC.

11.12 The FSSC must maintain compliance with all federal and state laws, regulations and guidelines governing patient privacy and medical records.

**History**
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *26 DE Reg. 211 (09/01/22)*
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *18 DE Reg. 378 (11/01/14)*
- *25 DE Reg. 627 (12/01/21)*
- *26 DE Reg. 211 (09/01/22)*

##### **16 Del. Admin. Code § 3355-12.0** Pharmaceutical Services {#sec-3355-12.0 omnilex-key=us-de-regs-official--title-16--3355-12.0}

12.1 Drugs shall be properly secured and accessible only to authorized personnel.

12.2 Drugs must be prepared and administered according to acceptable standards of practice.

12.3 The FSSC must designate a specific licensed healthcare professional to provide direction to the FSSC’s pharmaceutical service.

12.4 Orders given orally for drugs and biologicals must be followed by a written order and signed by the prescribing physician.

12.5 The FSSC must maintain compliance with all federal and state laws, regulations and guidelines governing pharmaceutical services.

**History**
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *26 DE Reg. 211 (09/01/22)*
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *18 DE Reg. 378 (11/01/14)*
- *25 DE Reg. 627 (12/01/21)*
- *26 DE Reg. 211 (09/01/22)*

##### **16 Del. Admin. Code § 3355-13.0** Laboratory and Radiologic Services {#sec-3355-13.0 omnilex-key=us-de-regs-official--title-16--3355-13.0}

13.1 FSSCs that perform laboratory services must meet federal and state requirements.

13.2 The scope and complexity of radiological services provided within the FSSC, either directly or under arrangement, as an integral part of the FSSC’s surgical services shall be specified in writing and approved by the governing body.

13.3 FSSCs that provide radiological services must meet professionally approved standards for safety and personnel qualifications.

13.3.1 The scope and complexity of radiological services offered should be specified in writing and approved by the medical staff and governing body.

13.3.2 Acceptable standards of practice include maintaining compliance with applicable federal and state laws, regulations and guidelines governing radiological services.

13.3.3 The FSSC must adopt and implement policies and procedures that provide safety for patients and personnel including but not limited to:

13.3.3.1 Adequate shielding for patients, personnel and surrounding areas;

13.3.3.2 Labeling of radioactive materials, waste and hazardous areas;

13.3.3.3 Transportation of radioactive materials between locations within the FSSC;

13.3.3.4 Security of radioactive materials, including determining who may have access to radioactive materials and controlling access to radioactive materials;

13.3.3.5 Testing of equipment for radiation hazards;

13.3.3.6 Maintenance of personal radiation monitoring devices;

13.3.3.7 Proper storage of radiation monitoring badges when not in use;

13.3.3.8 Storage of radio nuclides and radio pharmaceuticals as well as radioactive waste; and disposal of radio nuclides, unused radio pharmaceuticals, and radioactive waste; and

13.3.3.9 Methods of identifying pregnant patients.

13.3.4 The FSSC must have policies and procedures in place to ensure that periodic inspections of radiology equipment are conducted and current, and that problems identified are corrected in a timely manner. The FSSC must ensure that equipment is inspected in accordance with manufacturer’s instructions, federal and state laws, regulations, guidelines and FSSC policy.

13.3.5 Employees/contractors must be checked periodically, by the use of exposure meters or badge tests, for amount of radiation exposure.

**History**
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *26 DE Reg. 211 (09/01/22)*
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *18 DE Reg. 378 (11/01/14)*
- *25 DE Reg. 627 (12/01/21)*
- *26 DE Reg. 211 (09/01/22)*

##### **16 Del. Admin. Code § 3355-14.0** Patient Rights {#sec-3355-14.0 omnilex-key=us-de-regs-official--title-16--3355-14.0}

14.1 The FSSC must, prior to the start of a surgical procedure, provide the patient or the patient’s representative with verbal and written notice of the patient’s rights, in a language and manner that the patient or the patient’s representative understands.

14.2 The patient has the right to:

14.2.1 Receive care in a safe setting;

14.2.2 Be fully informed about a treatment or procedure and the expected outcome before it is performed; and

14.2.3 Voice grievances regarding treatment or care that is (or fails to be) furnished;

**History**
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *26 DE Reg. 211 (09/01/22)*
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *18 DE Reg. 378 (11/01/14)*
- *25 DE Reg. 627 (12/01/21)*
- *26 DE Reg. 211 (09/01/22)*

##### **16 Del. Admin. Code § 3355-15.0** Disaster Preparedness {#sec-3355-15.0 omnilex-key=us-de-regs-official--title-16--3355-15.0}

The FSSC must maintain a written disaster preparedness plan that provides for the emergency care of patients, staff and others in the FSSC in the event of fire, natural disaster, functional failure of equipment, or other unexpected events or circumstances that are likely to threaten the health and safety of those in the FSSC.

**History**
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *26 DE Reg. 211 (09/01/22)*
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *18 DE Reg. 378 (11/01/14)*
- *25 DE Reg. 627 (12/01/21)*
- *26 DE Reg. 211 (09/01/22)*

##### **16 Del. Admin. Code § 3355-16.0** Severability {#sec-3355-16.0 omnilex-key=us-de-regs-official--title-16--3355-16.0}

In the event any particular clause or section of these regulations should be declared invalid or unconstitutional by any court of competent jurisdiction, the remaining portions shall remain in full force and effect.

**History**
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *26 DE Reg. 211 (09/01/22)*
- *25 DE Reg. 627 (12/01/21)*
- *25 DE Reg. 627 (12/01/21)*
- *18 DE Reg. 378 (11/01/14)*
- *25 DE Reg. 627 (12/01/21)*
- *26 DE Reg. 211 (09/01/22)*

#### **3360** Regulations for Adult Day Care Facilities

##### **16 Del. Admin. Code § 3360-1.0** Purpose {#sec-3360-1.0 omnilex-key=us-de-regs-official--title-16--3360-1.0}

The regulations for Adult Day Care Facilities apply to any program that provides health, social, and related support services as described in these regulations for four or more functionally impaired adults who reside in the community and are in need of these services as determined by a pre-admission assessment. Adult Day Care facilities do not include programs intended exclusively or primarily to provide activities or training to persons with developmental disabilities or mental illness. These services are provided to adults for a period of less than 12 hours during the day and are provided in a setting other than a participant’s home or the residence of the facility operator.

**History**
- *6 DE Reg. 83 (07/01/02)*
- *6 DE Reg. 83 (07/01/02)*
- *6 DE Reg. 83 (07/01/02)*
- *15 DE Reg. 220 (08/01/11)*
- *25 DE Reg. 776 (02/01/22)*
- *6 DE Reg. 83 (07/01/02)*
- *15 DE Reg. 220 (08/01/11)*
- *25 DE Reg. 776 (02/01/22)*

##### **16 Del. Admin. Code § 3360-2.0** Glossary Of Terms {#sec-3360-2.0 omnilex-key=us-de-regs-official--title-16--3360-2.0}

“Accessible” means an environment which allows an individual using a wheelchair or support appliance to enter, exit and move about freely with no assistance from another person.

“Activities of Daily Living” means the tasks for selfcare which are performed either independently or with supervision or assistance. Activities of daily living include ambulating, transferring, grooming, bathing, dressing, eating, and toileting.

“Adult” means any person 18 years of age or older.

“Aide/Assistant/Technician” means individuals who provide care that does not require the judgment and skills of a licensed nurse. The care may include but is not limited to the following: bathing, dressing, grooming, toileting, ambulating, transferring and feeding, observing and reporting the general well-being for the person(s) to whom they are providing care.

“Department” means the Delaware Department of Health and Social Services.

“Dietitian” means a person currently registered by the Commission on Dietetic Registration of the American Dietetic Association and/or a Certified Dietitian/Nutritionist in the State of Delaware.

“Functionally Impaired Adult” means an adult who requires supervision due to cognitive or physical impairment or who cannot independently perform one or more Activities of Daily Living.

“Nursing Services” means those procedures commonly employed in providing for the physical, emotional and rehabilitation needs of functionally impaired adults which require technical skills and knowledge beyond that which the untrained person possesses, including, but not limited to, such procedures as: irrigations; catheterization; application of dressings; supervision of special diets; objective observation of changes in participant condition as a means of determining required nursing care and the need for further medical diagnosis and treatment; special procedures contributing to rehabilitation; administration of medication and carrying out treatments prescribed by a physician or an Advanced Practice Nurse in accordance with the Rules and Regulations related to the law regulating the practice of nursing in Delaware which involve a like level of complexity and skill in administration.

“Participant” means an individual receiving services in an adult day care facility.

“Representative” means a person acting on behalf of the participant under Delaware law.

**History**
- *6 DE Reg. 83 (07/01/02)*
- *6 DE Reg. 83 (07/01/02)*
- *6 DE Reg. 83 (07/01/02)*
- *15 DE Reg. 220 (08/01/11)*
- *25 DE Reg. 776 (02/01/22)*
- *6 DE Reg. 83 (07/01/02)*
- *15 DE Reg. 220 (08/01/11)*
- *25 DE Reg. 776 (02/01/22)*

##### **16 Del. Admin. Code § 3360-3.0** Licensing Requirements And Procedures {#sec-3360-3.0 omnilex-key=us-de-regs-official--title-16--3360-3.0}

3.1 No person shall establish, conduct or maintain in this State any adult day care facility without first obtaining a license from the Department of Health and Social Services.

3.1.1 Issuance of Licenses

3.1.1.1 Provisional License:

3.1.1.1.1 A provisional license shall be granted, for a period of less than one year, to all agencies/facilities:

3.1.1.1.1.1 which have completed the application process pending an on-site survey during the first ninety (90) days of operation; or,

3.1.1.1.1.2 which have experienced a change of ownership (CHOW), have completed the application process, and are pending an on-site survey during the first ninety (90) days of operation; or,

3.1.1.1.1.3 which are not in substantial compliance with these rules and regulations.

3.1.1.1.2 The Department shall designate the conditions and the time period under which a provisional license is issued.

3.1.1.1.3 A provisional license may not be renewed unless a Plan for Corrective Action has been approved by the Department and implemented by the agency/facility.

3.1.1.2 License:

3.1.1.2.1 A license shall be granted, for a period of one year (12 months), to all agencies/facilities which are and remain in substantial compliance with these rules and regulations.

3.1.1.2.2 A license shall be effective for a twelve-month period following date of issue and shall expire one year following such date, unless it is: modified to a provisional, suspended or revoked, or surrendered prior to the expiration date.

3.1.1.2.3 Agencies/Facilities must apply for licensure at least thirty (30) days prior to the expiration date of the license.

3.1.1.2.4 Agencies/Facilities which have not been inspected/surveyed during a licensure year may apply for and be issued a new license until an inspection/survey is completed.

3.1.1.2.5 A license may not be issued to an agency/facility which is not in substantial compliance with these regulations and/or whose deficient practices present an immediate threat to the health and safety of its patients/clients.

3.1.2 Suspension or Revocation of Licenses

3.1.2.1 The Department may suspend or revoke a license issued under this chapter for good cause, including but not limited to the following:

3.1.2.1.1 Violation of any of the provisions of these rules and regulations.

3.1.2.1.2 Deficiencies which present a threat to the health and safety of participants.

3.1.2.1.3 Permitting, aiding, or abetting the commission of any illegal act in the facility.

3.1.2.1.4 Conduct or practices detrimental to the welfare of the participant.

3.1.2.1.5 Refusal to allow the Department access to the facility to conduct surveys/investigations as deemed necessary by the Department.

3.1.2.2 Before any license issued under this chapter is suspended or revoked, the Department shall give ten (10) calendar days written notice to the holder of the license, during which he/she may appeal for a hearing before the Secretary of the Department or her/his designee.

3.1.2.3 The holder of the license may, within such 10-day period, give written notice of their desire to have a hearing. Proceedings in regard to such hearing shall be conducted in accordance with provisions for case decisions as set forth in the Administrative Procedures Act, Title 29, Chapter 101 of the Delaware Code and in accordance with applicable rules and regulations of the Department.

3.1.3 Order to Suspend a License

3.1.3.1 The Department may immediately suspend a license upon issuance of a written suspension order if the health, safety, or well-being of the participants is in jeopardy or imminent danger. The order shall state the reason(s) for the suspension.

3.1.3.2 Within ten (10) working days of the issuance of the suspension order, the Department shall hold a hearing with the licensee unless, prior to such hearing, the conditions upon which the suspension were based have been corrected and a new license issued.

3.1.4 Renewal of License after Suspension or Revocation

3.1.4.1 If and when the conditions upon which the suspension or revocation of a license are based have been corrected and after a proper inspection has been made, a new license may be granted.

3.1.5 Fees

3.1.5.1 Fees shall be in accordance with DE Code, Title 16, Part I, Chapter 1, Subchapter II, Section 122(3).s.2.

3.1.6 A license is not transferable from person to person or from one location to another.

3.1.7 The license shall be posted in a conspicuous place on the licensed premises.

3.2 Separate Licenses

3.2.1 Separate licenses are required for facilities maintained in separate locations, even though operated under the same management.

3.2.2 A separate license is not required for separate buildings maintained by the same management on the same grounds.

3.3 Inspection

3.3.1 Every adult day care facility for which a license has been issued under this chapter shall be periodically inspected by a representative of the Department. Regular inspections shall occur at least once every three years.

3.4 Application Process

3.4.1 All persons or entities applying for a license shall request a licensure application from the Department.

3.4.2 Applicants shall submit to the Department the following information:

3.4.2.1 The names, addresses and types of facility owned or managed by the applicant;

3.4.2.2 Identity of:

3.4.2.2.1 each officer and director of the corporation if the entity is organized as a corporation;

3.4.2.2.2 each general partner or managing member if the entity is organized as an unincorporated entity;

3.4.2.2.3 the governing body if the entity is government operated;

3.4.2.2.4 proof of not-for-profit status if claiming tax-exempt status; and

3.4.2.2.5 any officers/directors, partners, or managing members, or members of a governing body who have a financial interest of five (5) percent or more in a licensee’s operation or related businesses.

3.4.2.3 Disclosure of any officer, director, partner, employee, managing member, or member of the governing body with a felony criminal record;

3.4.2.4 Name of the individual (director/administrator/etc.) who is responsible for the management of the adult day care facility; and

3.4.2.5 Policy and procedure manuals and any other information required by the Department.

**History**
- *6 DE Reg. 83 (07/01/02)*
- *6 DE Reg. 83 (07/01/02)*
- *6 DE Reg. 83 (07/01/02)*
- *15 DE Reg. 220 (08/01/11)*
- *25 DE Reg. 776 (02/01/22)*
- *6 DE Reg. 83 (07/01/02)*
- *15 DE Reg. 220 (08/01/11)*
- *25 DE Reg. 776 (02/01/22)*

##### **16 Del. Admin. Code § 3360-4.0** General Requirements {#sec-3360-4.0 omnilex-key=us-de-regs-official--title-16--3360-4.0}

4.1 The adult day care provider shall neither knowingly admit, nor continue to care for, participants whose needs cannot be met by the program.

4.2 All records maintained by the adult day care facility shall at all times be open to inspection by the authorized representatives of the Department.

4.3 No policies shall be adopted by the adult day care facility which are in conflict with these regulations.

4.4 The adult day care facility shall establish written policies regarding the rights and responsibilities of participants, and these policies and procedures shall be made available to authorized representatives of the Department.

4.5 The adult day care facility shall establish policies and procedures that address the handling and documentation of incidents, accidents, medical emergencies and the prevention of wandering away from safe areas by participants with cognitive disabilities. Reports of these events shall be kept on file at the facility.

4.6 Emergency telephone numbers for each participant shall be available to staff at all times.

4.7 A procedure, approved by the Department, and including the participants and families right to report concerns/complaints to the Department of Health and Social Services, shall be established to enable participants and their families or representatives, if any, to have their concerns addressed without fear of reprisal.

4.8 The adult day care facility shall advise the Department in writing within fifteen (15) days following any change in the designation of the director/administrator of the facility.

**History**
- *6 DE Reg. 83 (07/01/02)*
- *6 DE Reg. 83 (07/01/02)*
- *6 DE Reg. 83 (07/01/02)*
- *15 DE Reg. 220 (08/01/11)*
- *25 DE Reg. 776 (02/01/22)*
- *6 DE Reg. 83 (07/01/02)*
- *15 DE Reg. 220 (08/01/11)*
- *25 DE Reg. 776 (02/01/22)*

##### **16 Del. Admin. Code § 3360-5.0** Plant, Equipment And Physical Environment {#sec-3360-5.0 omnilex-key=us-de-regs-official--title-16--3360-5.0}

5.1 Construction

5.1.1 Minimum construction requirements are set forth herein.

5.1.2 All construction, new/renovations/remodeling, must conform to the design and construction standards recognized by the Department.

5.1.3 In the event that there is a conflict between the design and construction standard utilized by the Department and the minimum standard set forth herein, the higher standard or requirement shall prevail.

5.1.4 When a facility is classified under this law or regulation and plans to construct, extensively remodel or convert any buildings, one (1) copy of properly prepared plans and specifications for the entire facility shall be submitted to the Department.

5.1.5 An approval, in writing, shall be obtained from the Department before construction/renovation/remodeling work is begun.

5.1.6 Upon completion of construction/renovation/remodeling, in accordance with the plans and specifications, the Department will inspect and approve the site prior to occupancy/use by the agency/facility.

5.2 Site Provisions

5.2.1 Each adult day care facility shall be located on a site which is approved in advance and considered suitable by the Department. Site must be safe, easily drained, must be suitable for disposal of sewage and furnishing a potable water supply.

5.3 The adult day care facility shall comply with all local and state building codes and ordinances as pertain to this occupancy.

5.4 Building

5.4.1 All facilities shall either be at grade level or shall be equipped with ramps or elevators to allow easy access for persons with disabilities.

5.4.2 The building shall be so constructed and maintained to prevent the entrance or existence of rodents and insects at all times. All exterior openings used for ventilation shall be effectively screened. Screen doors shall open outward and shall be equipped with self-closing devices.

5.4.3 The roof, exterior walls, doors, skylights and windows shall be weather tight and watertight and shall be kept in sound condition and good repair.

5.4.4 The exterior of the site shall be free from hazards and also from the accumulation of waste materials, obsolete and unnecessary articles, tin cans, rubbish, and other litter.

5.4.5 Floor and wall surfaces of bathrooms and kitchens shall be constructed and maintained to be impervious to water and to permit the floor and walls to be easily kept in a clean condition.

5.4.6 The adult day care facility must be accessible as defined at Section 2.0. The entrance and circulation areas shall meet appropriate American National Standards Institute (A.N.S.I.) standards and all applicable State and Federal standards.

5.4.7 Each adult day care facility, when located in a facility housing other services, shall have its own separate identifiable space.

5.4.8 Outdoor recreation and/or relaxation area for participants, if provided, shall be safe, secure, free of accident hazards, accessible to indoor areas and accessible to those with disabilities. Outdoor areas shall have a fence or landscaping to create a boundary which prevents participants from wandering away and shall be easily supervised.

5.5 Water Supply and Sewage Disposal

5.5.1 The plumbing shall meet the requirements of all municipal or county codes. Where there are no local codes, the provisions of the Department Sanitary Plumbing Code shall prevail.

5.5.2 The water supply and the sewage disposal system shall be approved by the Department and the Department of Natural Resources and Environmental Control respectively.

5.5.3 The water system shall be designed to supply adequate hot and cold water, under pressure, at all times.

5.5.4 Hot water at shower, bathing and hand washing facilities shall not exceed 110°F (43°C).

5.6 Heating, Ventilation and Air Conditioning

5.6.1 The heating equipment for all areas shall be adequate, safe, protected, and easily controlled. It shall be capable of maintaining the temperature in each room used by participants between 70ºF and 80ºF. Portable heating devices shall not be used.

5.6.2 The adult day care facility shall be adequately ventilated. Air conditioning equipment shall be adequate and capable of maintaining the temperature in each room used by participants between 70ºF and 80ºF.

5.7 Lighting

5.7.1 Each room shall be suitably lighted at all times for maximum safety, comfort, sanitation and efficiency of operation particularly in areas that present safety hazards. Careful attention shall be given to avoid glare.

5.8 Safety Equipment

5.8.1 To prevent slipping, staircases shall have stair treads and sturdy handrails.

5.8.2 Stairways, ramps and porches shall have adequate lighting and handrails.

5.8.3 Hallways shall have handrails located on at least one side.

5.8.4 Floor surfaces, especially in heavy traffic areas shall be durable, yet non-abrasive and slip-resistant. Area rugs on hard finished floors shall have a non-skid backing. Carpeting shall be maintained in a clean and slip-resistant condition.

5.9 Bathrooms and Hand Washing Facilities

5.9.1 At least one (1) window or mechanical ventilation to the outside shall be provided in each bathroom. Floors shall not be slippery.

5.9.2 Bathroom design shall be accessible as defined at Section 2.0 and meet appropriate American National Standards Institute (A.N.S.I.) Standards.

5.9.3 Toilets, bathing and toileting appliances shall be equipped for use by participants with multiple disabilities.

5.9.4 There shall be at least one toilet of appropriate size for every twelve participants.

5.9.4.1 Each toilet shall be equipped with a toilet seat.

5.9.4.2 Toilet tissue shall be readily accessible at each toilet.

5.9.5 There shall be at least one hand-washing sink for every two toilets. The sink(s) shall be proximate to the toilets. Hand washing facilities shall be readily accessible to participants and staff.

5.9.6 Shower and tub areas, if provided, shall be equipped with grab bars and slip-resistant surfaces.

5.9.7 Bathroom areas shall be equipped with mirrors for personal grooming. Mirrors shall be installed in such a way to minimize the danger of breakage.

5.9.8 Soap, paper towels and a trash receptacle(s) shall be provided at all times and shall be within reach of the participants.

5.9.9 Signaling devices shall be installed or placed in the bathroom areas, restroom stalls, and showers, if any.

5.10 Program Area

5.10.1 When a multipurpose room is used, it shall have sufficient space to accommodate all activities and to prevent interference with each other. There shall be sufficient space to permit privacy and confidentiality.

5.10.2 Square Footage

5.10.2.1 Minimum space requirements are as follows:

5.10.2.1.1 100 square feet for each of the first five participants; and

5.10.2.1.2 60 square feet for each of the participants thereafter.

5.10.2.2 Space requirements do not include office space, bathrooms, storage, examination room, or dining room (unless the dining room is also used for activities).

5.10.3 A telephone shall be available to participants to make and receive calls. Telephones shall be in an area which affords privacy during use.

5.10.4 The adult day care facility shall maintain comfortable sound levels. Background noise shall be minimized and sound transmission shall be controlled. Sound transmission may be controlled by use of acoustical ceiling surfaces, partitions between activity areas, and separation of noisy rooms. Sound levels shall enhance privacy and encourage interaction when social participation is desired.

5.10.5 There shall be adequate storage space for program supplies and for participants’ outer garments and possessions.

5.10.6 The dining area shall be large enough to provide table and chair space to accommodate all participants.

5.10.7 The adult day care facility shall provide a separate rest area to permit privacy for assessments and to isolate participants who become ill. A bed, cot or other appropriate lounging or reclining furniture shall be available for participants in this area.

5.10.8 Adult day care facilities which provide rehabilitation services shall have separate additional space and equipment for carrying out each type of therapy that may be provided. At a minimum, the following shall be provided:

5.10.8.1 Provisions for wheelchair participants;

5.10.8.2 Additional storage for supplies and equipment;

5.10.8.3 Provisions for participant privacy; and

5.10.8.4 Hand washing facilities within the rehabilitation area.

5.11 Furnishings

5.11.1 Furniture shall be sturdy and secure so that it cannot easily tip when used for support while walking or seating. Furniture shall be scaled so that it is easily used by persons with limited agility and shall permit feet to rest on the floor. Chairs used for dining shall have armrests or be free of armrests in accordance with each participant’s physical needs and preferences.

5.11.2 All rugs and floor coverings shall be tacked down securely. Any mat used at a doorway shall be non-slip with edges that do not cause a tripping hazard.

5.11.3 All equipment and furnishings shall be in good condition and safe for usage by participants and staff. The adult day care facility shall provide:

5.11.3.1 One chair for each participant and staff person;

5.11.3.2 Adequate table space for all participants; and

5.11.3.3 Reclining lounge chairs, the number to be determined by the needs and numbers of participants.

5.12 Emergency Equipment and Supplies

5.12.1 The adult day care facility shall provide adequate emergency equipment and supplies readily available for treating shock, burns and wounds, including:

5.12.1.1 First aid kit containing sterile gauze dressings and bandages, antiseptic, tape and scissors;

5.12.1.2 Thermometers; and,

5.12.1.3 Sphygmomanometers and stethoscopes.

5.12.2 Special equipment as needed by the participant (i.e. suction equipment, oxygen, etc.) may be supplied by the adult day care facility or the participant.

5.13 Sanitation and Housekeeping

5.13.1 All rooms and every part of the building shall be kept clean, orderly and free of offensive odors.

5.13.2 Policy manuals shall be prepared and followed which outline maintenance and cleaning procedures, safe storage of cleaning materials and pesticides and other potentially toxic materials, and safe storage and handling of soiled linen and clothing.

5.13.3 A ventilated janitor’s closet shall contain a service sink and provide for the locked safe storage and use of housekeeping items.

5.13.4 Chemicals and disinfection agents shall be stored separate from participant care items and food.

5.14 Existing Facilities

5.14.1 Adult day care facilities that have been in operation before the adoption of these regulations and do not meet the minimum square footage, dining area and bathroom ratio requirements set forth in Section 5.0 must be brought into full compliance within a five (5) year period. All other provisions of these regulations apply upon their adoption except as otherwise expressly provided.

5.15 Waiver of Requirements

5.15.1 Waiver of a standard requires Department approval. Waiver requests must be made in writing, include the full justification behind the request and address issues of safety and infection control. They are an exception to established standards and will only be approved for compelling reason.

5.15.1.1 Waiver requests which could potentially impact the health, safety or welfare of the participants must be shared with the participants and their representatives prior to submission of the waiver request to the Department.

5.15.1.1.1 Participants must be informed that they may voice their objections to any waiver request by contacting the Department.

**History**
- *6 DE Reg. 83 (07/01/02)*
- *6 DE Reg. 83 (07/01/02)*
- *6 DE Reg. 83 (07/01/02)*
- *15 DE Reg. 220 (08/01/11)*
- *25 DE Reg. 776 (02/01/22)*
- *6 DE Reg. 83 (07/01/02)*
- *15 DE Reg. 220 (08/01/11)*
- *25 DE Reg. 776 (02/01/22)*

##### **16 Del. Admin. Code § 3360-6.0** Fire Safety {#sec-3360-6.0 omnilex-key=us-de-regs-official--title-16--3360-6.0}

6.1 Fire safety in adult day care facilities shall comply with the adopted rules and regulations of the State Fire Prevention Commission. Enforcement of Fire Regulations is the responsibility of the State Fire Prevention Commission. All applications for a license or renewal of a license must include, with the application, a letter certifying compliance by the Fire Marshal having jurisdiction. Notification of noncompliance with the Rules and Regulations of the State Fire Prevention Commission shall be grounds for revocation of a license.

6.2 The adult day care facility shall have a minimum of two (2) exits remote from each other which shall be clearly marked.

6.3 Staff and participants shall be trained in executing the evacuation plan. A written record of fire safety training, including content of the training and persons attending shall be maintained.

6.4 Evacuation fire drills shall be held and documented at least quarterly for all staff and participants.

**History**
- *6 DE Reg. 83 (07/01/02)*
- *6 DE Reg. 83 (07/01/02)*
- *6 DE Reg. 83 (07/01/02)*
- *15 DE Reg. 220 (08/01/11)*
- *25 DE Reg. 776 (02/01/22)*
- *6 DE Reg. 83 (07/01/02)*
- *15 DE Reg. 220 (08/01/11)*
- *25 DE Reg. 776 (02/01/22)*

##### **16 Del. Admin. Code § 3360-7.0** Admission Agreement, Assessment And Discharge {#sec-3360-7.0 omnilex-key=us-de-regs-official--title-16--3360-7.0}

7.1 The adult day care facility shall have written admission policies which describe admission and discharge criteria.

7.2 The admission policies shall be discussed with each participant entering the program, and their representative, if any.

7.3 The adult day care facility shall only admit those individuals whose needs can be met by the facility.

7.4 All participants shall be 18 years of age or older and functionally impaired as defined at Section 2.0.

7.5 There shall be a written agreement between the participant and the adult day care program. The agreement shall:

7.5.1 Specify the services to be provided by the facility, scheduled days, financial arrangements, transportation agreements, emergency procedures and conditions for dismissal or discharge and appeal;

7.5.2 Be signed by the participant, if he is able, and representative, if any, and the adult day care facility;

7.5.3 Be given to the participant and representative, if any, and a copy shall be kept at the facility; and

7.5.4 Be reviewed and updated as necessary to reflect the change in the services or the financial arrangements.

7.6 Assessment

7.6.1 The facility shall be responsible for conducting a written assessment of an applicant within 30 days prior to admission. The assessment shall include input as required from physicians, licensed nurses, social workers, physical and occupational therapists, and other personnel with expertise as required by the participant’s needs.

7.6.2 The assessment shall be completed by the adult day care facility in conjunction with the participant and her/his representative, if any.

7.6.3 The assessment shall include at a minimum a description of the participant’s:

7.6.3.1 Physical condition, including ability to perform activities of daily living, such as ambulating, eating, toileting, and sensory limitations such as sight, hearing, and speech completed by a licensed nurse;

7.6.3.2 Social situation, including living arrangements and the availability of family and community support; and,

7.6.3.3 Mental status, including any cognitive impairment and known psychiatric, emotional, and behavioral problems.

7.6.4 The initial assessment shall be reviewed and updated on a scheduled basis, but at least annually. This reassessment shall become a permanent part of the participant’s record.

7.6.5 A reassessment shall be conducted when the needs of the participant change which indicate a revision to the plan of care is needed.

7.7 Discharge

7.7.1 No participant shall be discharged from an adult day care facility except for the following:

7.7.1.1 The participant’s needs can no longer be met by the program of care;

7.7.1.2 Medical reasons;

7.7.1.3 Non-participation in the plan of care or non-compliance with the written admission agreement;

7.7.1.4 The participant’s own welfare or the welfare of the other participants; or

7.7.1.5 Nonpayment of justified charges.

7.7.2 The participant and her/his representative, if any, shall be informed of and participate in discharge planning. A minimum of 2 weeks notice shall be given by the adult day care facility to the participant and representative, if any. However, the notice period may be waived if the care needs of the participant undergo a sudden change which necessitates immediate transfer to a facility or program able to provide a higher level of care. If the notice provisions are waived, the facility shall be responsible for assisting in suitable placement for the participant.

7.7.3 The adult day care facility shall develop a written plan of discharge which outlines the services needed by the participant upon discharge.

**History**
- *6 DE Reg. 83 (07/01/02)*
- *6 DE Reg. 83 (07/01/02)*
- *6 DE Reg. 83 (07/01/02)*
- *15 DE Reg. 220 (08/01/11)*
- *25 DE Reg. 776 (02/01/22)*
- *6 DE Reg. 83 (07/01/02)*
- *15 DE Reg. 220 (08/01/11)*
- *25 DE Reg. 776 (02/01/22)*

##### **16 Del. Admin. Code § 3360-8.0** Plan Of Care {#sec-3360-8.0 omnilex-key=us-de-regs-official--title-16--3360-8.0}

8.1 Prior to admission, a preliminary written plan of care, based upon the initial assessment shall be developed for each participant.

8.2 A written individual plan of care shall be developed within thirty (30) calendar days of the participant’s first day in the program. The plan shall be based on a functional assessment and information obtained from the participant, participant’s family, physician, and the referring agency (if appropriate).

8.3 The plan shall be developed to improve or maintain the functional capabilities of the participant. The plan shall include:

8.3.1 A description of the participant’s needs;

8.3.2 The activities, programming and services in which the person will participate in order to meet those needs; and

8.3.3 Realistic goals for the participant, designated roles of the responsible parties, and if appropriate, the timeline for each goal.

8.4 The written plan of care and personal information shall be revised as frequently as warranted by the participant’s condition, but shall be reviewed at least every six (6) months with the participant and representative, if any, and updated on an annual basis. All revisions to the plan of care shall be in writing.

**History**
- *6 DE Reg. 83 (07/01/02)*
- *6 DE Reg. 83 (07/01/02)*
- *6 DE Reg. 83 (07/01/02)*
- *15 DE Reg. 220 (08/01/11)*
- *25 DE Reg. 776 (02/01/22)*
- *6 DE Reg. 83 (07/01/02)*
- *15 DE Reg. 220 (08/01/11)*
- *25 DE Reg. 776 (02/01/22)*

##### **16 Del. Admin. Code § 3360-9.0** Support Services {#sec-3360-9.0 omnilex-key=us-de-regs-official--title-16--3360-9.0}

9.1 Aide/Assistant/Technician as defined at Section 2.0 or licensed nurses shall provide supervision and assistance in activities of daily living, such as feeding and toileting, to participants who require those services. Facilities that have been in operation before the adoption of these regulations shall comply with this requirement within 12 months of the adoption date of the regulations.

9.2 Rehabilitation services, including occupational therapy, physical therapy, and speech therapy, if provided, shall be ordered by the participant’s physician and be performed by qualified therapists or therapy aides under supervision of a qualified therapist.

9.3 Medication Management

9.3.1 Medication shall not be administered to a participant unless prescribed by a licensed practitioner with independent prescriptive authority as provided by Delaware Code.

9.3.2 All adult day care programs shall have an up-to-date drug reference manual/compendium which lists drug actions, interactions, and side effects.

9.3.3 All medication administered to participants shall be ordered in writing, dated and signed by the attending physician. All prescription medications shall be properly labeled in accordance with DE Code, Title 24, Chapter 25, Subchapter III, §2536. The label shall contain the following information:

9.3.3.1 The prescription number;

9.3.3.2 The date such drugs were originally dispensed to the participant;

9.3.3.3 The participant’s full name;

9.3.3.4 The brand or established name and strength of the drug to the extent that it can be measured;

9.3.3.5 The physician’s directions as found on the prescription;

9.3.3.6 The physician’s name;

9.3.3.7 The name and address of the dispensing pharmacy or physician.

9.3.4 Medications may be self-administered or administered in accordance with all State and Federal laws, including the State of Delaware Nurse Practice Act. Those participants who, upon admission, are incapable of self-administration or who become incapable of self-administration shall have their medications administered according to the Nurse Practice Act.

9.3.5 The adult day care facility shall maintain a record of all medication provided to a participant indicating time of day, type of medication, dose, route of self-administration/administration, by whom given and any reactions noted.

9.3.6 Medication Storage

9.3.6.1 If medications are administered on site, provisions for the locked storage of medications shall be provided. The key to the medication storage must be in the possession of or accessible only to authorized licensed personnel responsible for the distribution for self-administration/administration of medications.

9.3.6.2 Prescription medication not requiring refrigeration shall be kept in the original container stored in a locked cabinet or drawer, and clearly labeled for the specific participant. These medications shall be stored within the U.S.P. recommended temperature range of 59° - 86°F unless the manufacturer’s labeling states otherwise.

9.3.6.2 Prescription medication requiring refrigeration shall be stored in a separate and secured locked container within the refrigerator. The temperature must be maintained within the U.S.P. recommended range of 36º - 46ºF.

9.3.6.3 For the safety and welfare of all participants, medication to be self-administered shall be stored as noted and distributed to the participant as requested.]

9.3.6.4 Schedule II substances/prescriptions shall be kept in separately locked, securely fixed boxes (approved under Delaware law and standards) or drawers in the secure locked medication cabinet. Medication cabinets utilized will have a 2-lock system.

9.3.6.4.1 Schedule II substances shall be handled in the manner outlined by the State and Federal laws and regulations.

9.3.6.4.2 Schedule II substances brought to the facility by the participant/family on a daily basis shall be counted with the participant/family when received in the facility and shall be counted with the participant/family before removed from the facility.

9.3.6.4.3 Schedule II substances brought to the facility and remaining in the facility shall be counted with the participant/family when received in the facility and the empty container shall be returned to the participant/family for disposition.]

9.3.6.4.4 All unused Schedule II substances shall be returned to the participant or representative for disposition.

9.3.6.4.5 The adult day care facility must develop policies to prevent possible diversion of controlled substances.

9.3.6.5 Internal medications shall be stored separately from external medications.

9.3.7 The adult day care facility shall ensure that prescription medication is not used by other than the participant for whom the medication was prescribed.

9.3.8 The adult day care facility shall develop policies to permit those participants who are able to self-administer medication to keep and use such over-the-counter products as cough drops, lip balm and skin moisturizer.

9.3.9 The center may maintain a supply of over-the-counter medications, such as antacids and aspirin. However, over-the-counter medications shall only be administered upon the order of the participant’s physician.

9.3.10 Used needles and syringes shall not be recapped, but placed immediately after use into an approved and secured Sharps container and disposed of properly.

9.4 Transportation Services

9.4.1 When transportation services are provided directly or under contract by the adult day care facility:

9.4.1.1 The vehicle shall be accessible and appropriate to the participants using it, considering any physical disabilities and impairments.

9.4.1.2 Every participant shall have a seat in the vehicle, except those participants who remain in their wheelchairs.

9.4.1.3 Wheelchairs shall be secured when the vehicle is in motion.

9.4.1.4 Each participant shall be seated while the vehicle is in motion.

9.4.1.5 Vehicles shall have adequate seat belt and securement devices for ambulatory and wheelchair bound passengers.

9.4.1.6 Participants shall not be left unsupervised (must always be within eyesight of the driver/attendant) while in a vehicle.

9.4.1.7 Assistance by a driver or attendant shall be provided from the ground floor of the passenger’s residence to the ground floor of the day care facility.

9.4.1.8 The driver shall have a valid and appropriate Delaware driver’s license. The driver shall meet any state requirements for licensure or certification for the vehicle operated.

9.4.1.9 Each vehicle shall have a first aid kit, along with fire extinguisher and safety triangles.

9.4.1.10 The driver or attendant shall be trained in first aid procedures which include but are not necessarily limited to the following:

9.4.1.10.1 Cardiopulmonary Resuscitation (CPR);

9.4.1.10.2 Care during a seizure;

9.4.1.10.3 Care of minor scrapes and abrasions; and,

9.4.1.10.4 Summoning help in the event of an emergency.

9.4.1.11 The driver or attendant shall have medical and emergency information in the vehicle for participants being transported.

9.4.1.12 All transportation vehicles shall be equipped with a device for two-way communication.

9.5 Nutrition and Food Services

9.5.1 Kitchen and Food Storage Areas

9.5.1.1 If meals are prepared by the adult day care facility the State of Delaware Food Code shall apply.

9.5.2 The adult day care facility shall assure the availability of meals and supplemental snacks in accordance with each participant’s individual plan of care.

9.5.3 The adult day care facility shall provide or make arrangements for a minimum of one meal daily which is of suitable quality and quantity for participants who are in the center for four (4) or more hours. The meal shall meet at least one-third (1/3) of an adult’s current recommended dietary allowance (RDA) of the Food and Nutrition Board, National Academy of Sciences-National Research Council.

9.5.4 A morning snack shall be offered daily to participants. Those participants remaining in the facility for more than three (3) hours after completion of lunch shall be offered a mid-afternoon snack. Facilities open in the evening shall serve an evening meal. Evening meals shall be served approximately four (4) hours after completion of lunch, but no later than seven (7) p.m. Beverages shall be available to participants at all times and shall be offered periodically to promote good hydration. Snacks shall have nutritional value.

9.5.5 Food shall be stored, prepared, served, or any combination of these on site in accordance with the State of Delaware Food Code.

9.5.6 Food that is prepared for the adult day facility at an alternate site shall be prepared in a facility which is in compliance with the State of Delaware Food Code and has been issued a permit.

9.5.7 Menus shall be planned and written for a minimum of a two-week cycle, if meals are prepared on-site, and approved by a dietitian.

9.5.8 The menu shall be dated for the week of service and posted in a prominent area for the availability to the participant and representative, if any.

9.5.9 A therapeutic diet shall be provided for a participant when prescribed in writing by a physician. Therapeutic diet menus shall be prepared by a dietitian.

9.5.10 A dietitian shall be available for consultation with staff on basic and special nutritional needs and proper food handling techniques and shall provide in-service training to staff on these topics at least annually.

9.5.11 Appropriate food containers and utensils shall be available as needed for use by disabled participants.

9.5.12 Equipment for adequate refrigeration to maintain foods at 40°F and for the heating of foods shall be provided if needed to assist in the provision of meals and snacks.

9.5.13 Drinking water shall be easily accessible to the participants and provided by either an angle jet drinking fountain with mouth guard or by a running water supply with individual service drinking cups.

9.6 Nursing Services

9.6.1 Nursing services may be provided by the adult day care facility in accordance with the Delaware Nurse Practice Act and shall meet the needs of the participants.

**History**
- *6 DE Reg. 83 (07/01/02)*
- *6 DE Reg. 83 (07/01/02)*
- *6 DE Reg. 83 (07/01/02)*
- *15 DE Reg. 220 (08/01/11)*
- *25 DE Reg. 776 (02/01/22)*
- *6 DE Reg. 83 (07/01/02)*
- *15 DE Reg. 220 (08/01/11)*
- *25 DE Reg. 776 (02/01/22)*

##### **16 Del. Admin. Code § 3360-10.0** Activities {#sec-3360-10.0 omnilex-key=us-de-regs-official--title-16--3360-10.0}

10.1 Each facility licensed under these regulations shall provide appropriate programming for each participant. Programming shall take into consideration individual differences in age, health status, sensory deficits, lifestyle, ethnicity, religious affiliation, values, experiences, needs, interests, abilities, and skills by providing opportunities for a variety of types and levels of involvement.

10.2 Activities shall be planned to support the plans of care for the participants, and shall be consistent with the program statement and the admission policies.

10.3 Activities shall be planned and shall include:

10.3.1 Group activities for all participants; and

10.3.2 Personalized options for individuals with varying interests and needs.

10.4 Activity Schedule

10.4.1 The adult day care program shall provide planned activities during at least sixty-five percent (65%) of the time that the program is open for daily operations.

10.4.2 A written schedule of activities shall be developed at least monthly.

10.4.3 Changes in activities shall be noted on the schedule.

10.4.4 The current month’s schedule of activities shall be posted in a conspicuous place and made available to participants and their representatives, where applicable, including the name or type, date and hour of the activity.

10.4.5 The schedule of activities for the past twelve months shall be maintained by the adult day care facility.

10.5 Activities Coordinator

10.5.1 There shall be an Activities Coordinator who shall have either:

10.5.1.1 A Bachelor’s Degree plus one year of experience (full-time or equivalent) in developing and conducting activities for the population to be served; or

10.5.2 An Associates Degree in a related field plus two years of appropriate experience; or

10.5.3 National Certification as an activity or therapeutic recreational professional plus two years of appropriate experience.

10.5.4 A high school diploma or equivalent plus three years of experience in developing and conducting activities for the population to be served in the program.

10.5.5 Existing facilities shall have twelve (12) months from the adoption of these regulations to comply with this requirement.

10.6 Equipment and Supplies

10.6.1 The facility shall provide equipment to encourage active participation and group interaction and materials shall be geared to the interests and backgrounds of the participants.

10.6.2 Environmental aids and supplies for activities shall be provided as required by the participants’ needs and the goals of the program.

**History**
- *6 DE Reg. 83 (07/01/02)*
- *6 DE Reg. 83 (07/01/02)*
- *6 DE Reg. 83 (07/01/02)*
- *15 DE Reg. 220 (08/01/11)*
- *25 DE Reg. 776 (02/01/22)*
- *6 DE Reg. 83 (07/01/02)*
- *15 DE Reg. 220 (08/01/11)*
- *25 DE Reg. 776 (02/01/22)*

##### **16 Del. Admin. Code § 3360-11.0** Rights Of Participants {#sec-3360-11.0 omnilex-key=us-de-regs-official--title-16--3360-11.0}

11.1 Each participant shall be treated as an adult, with respect and dignity.

11.2 Each participant shall have the right to participate in a program of services and activities which promotes positive attitudes regarding one’s usefulness and capabilities.

11.3 Each participant shall have the right to participate in a program of services designed to encourage learning, growth and awareness of constructive ways to develop one’s interests and talents.

11.4 Each participant shall have the right to be encouraged and supported in maintaining one’s independence to the extent that conditions and circumstances permit, and to be involved in a program of services designed to promote personal independence.

11.5 Each participant shall have the right to self-determination and choice within the adult day care setting, including the opportunity to:

11.5.1 Participate in developing one’s plan for services;

11.5.2 Decide whether or not to participate in any given activity; and

11.5.3 Be involved, to the greatest extent possible, in program planning and operation.

11.6 Each participant shall have the right to privacy and confidentiality.

11.7 Each participant shall have the right to be protected from abuse, neglect, mistreatment, financial exploitation, solicitation and harassment.

11.8 Each participant shall have the right to voice grievances without discrimination or reprisal.

11.9 Each participant shall have the right to be free from physical and chemical restraints. When a restraint becomes necessary, the facility must comply with federal law 42 CFR 482.13 and 42 CFR 483.13 and state law (16 Del.C. §1121).

11.10 Each participant shall have the right to be fully informed, as evidenced by the participant’s written acknowledgment of these rights, and of all rules and regulations regarding participant conduct and responsibilities.

11.11 Each participant shall have the right to be fully informed, at the time of acceptance into the program, of services and activities available and related charges.

**History**
- *6 DE Reg. 83 (07/01/02)*
- *6 DE Reg. 83 (07/01/02)*
- *6 DE Reg. 83 (07/01/02)*
- *15 DE Reg. 220 (08/01/11)*
- *25 DE Reg. 776 (02/01/22)*
- *6 DE Reg. 83 (07/01/02)*
- *15 DE Reg. 220 (08/01/11)*
- *25 DE Reg. 776 (02/01/22)*

##### **16 Del. Admin. Code § 3360-12.0** Staffing {#sec-3360-12.0 omnilex-key=us-de-regs-official--title-16--3360-12.0}

12.1 There shall be at least two adult day care facility staff on duty at all times when participants are present. If separate sections are established within each facility, each separate section shall independently comply with the staffing requirements of this section. The minimum staffing requirements shall not include volunteers or employees who have not yet completed the required orientation program.

12.2 For facilities with more than sixteen (16) participants there shall be a minimum of one adult staff person on duty for each eight participants (1:8). Facilities may not use rounding in determining staffing requirements, i.e., for seventeen to twenty-four (17-24) participants at least three (3) staff members would be required, for twenty-five to thirty-two (25-32) participants at least four (4) staff members, etc.

12.2.1 As the number or acuity of participants with functional and cognitive impairments increase the staff-participant ratio shall be adjusted accordingly to meet the needs of the participants.

12.2.2 Supervision of each participant shall be based upon the comprehensive assessment of the individual’s needs.

12.3 Programs serving mainly participants with severe cognitive or physical disabilities shall have a staff-participant ratio of at least one to four (1:4) for all severely disabled participants.

12.4 There shall be at least one RN or LPN on the premises at all times, when participants are present, for those facilities serving participants requiring nursing services as defined at 2.0.

12.5 There shall be at least one employee on the premises at all times, when participants are present, who is certified in cardiovascular pulmonary resuscitation (CPR).

12.6 The individual (director/administrator/etc.) or designee responsible for the management of the adult day care program shall be present and in charge during all hours that participants are on the premises.

**History**
- *6 DE Reg. 83 (07/01/02)*
- *6 DE Reg. 83 (07/01/02)*
- *6 DE Reg. 83 (07/01/02)*
- *15 DE Reg. 220 (08/01/11)*
- *25 DE Reg. 776 (02/01/22)*
- *6 DE Reg. 83 (07/01/02)*
- *15 DE Reg. 220 (08/01/11)*
- *25 DE Reg. 776 (02/01/22)*

##### **16 Del. Admin. Code § 3360-13.0** Personnel/administrative {#sec-3360-13.0 omnilex-key=us-de-regs-official--title-16--3360-13.0}

13.1 Adult day care providers must comply with the special employment practices relating to health care and child care facilities (19 Del.C. §708 and 11 Del.C. §8563) and adult abuse registry check (11 Del.C. §8564) and the regulations promulgated by the Department of Labor regarding same.

13.2 No employee shall be less than 18 years of age and no person shall be employed who has been convicted of a crime where the victim was a person regardless of whether the crime was a felony or a misdemeanor.

13.3 The facility shall have written personnel policies and procedures that adequately support sound care and services to participants.

13.4 Personnel records of each employee shall be kept current and available upon request by the Department’s representatives and shall contain sufficient information to support placement in the positions to which assigned.

13.5 Minimum requirements for pre-employment and annual tuberculosis (TB) testing are those currently recommended by the Centers for Disease Control and Prevention of the U.S. Department of Health and Human Services.

13.5.1 No person, including volunteers, found to have active tuberculosis in an infectious stage shall be permitted to give care or service to participants.

13.5.2 Any person having a positive skin test but a negative X-ray must complete a statement annually attesting that they have experienced no symptoms which may indicate active TB infection.

13.5.3 A report of all test results and all attestation statements shall be on file at the facility of employment.

13.6 All new employees shall be required to have a pre-employment physical examination. A copy of the pre-employment physical examination shall be maintained in individual personnel files.

13.7 Any individual who cannot adequately perform her/his duties or who may jeopardize the health or safety of the participants shall be relieved of his duties and removed from the center until such time as the condition is resolved. This includes infections of a temporary nature.

13.8 The adult day care provider shall provide for systematic performance review to communicate expectations and responsibilities, recognize achievement, and identify areas for skill development and work performance improvement. Performance reviews shall be completed annually and shall be maintained in the employee personnel record.

13.9 The director/administrator shall be responsible for complying with the regulations herein contained. In the absence of the director, a qualified substitute shall be authorized, in writing, to be in charge.

13.10 The director’s/administrator’s responsibilities shall include, but not be limited to, the following areas:

13.10.1 The development of the content of the program offered to the participants;

13.10.2 Programmatic functions, including orientation, training, and scheduling of all staff whether or not the director personally performs these functions; and

13.10.3 Assignment of a sufficient number of qualified staff to meet the participant’s needs for:

13.10.3.1 Adequate nutrition;

13.10.3.2 Health supervision and maintenance;

13.10.3.3 Personal care;

13.10.3.4 Socialization;

13.10.3.5 Recreation;

13.10.3.6 Activities and stimulation; and,

13.10.3.7 Supervision, protection, and safety.

13.11 The director shall have a Bachelor’s Degree in health or social services or a related field, with one (1) year supervisory experience (full-time or equivalent) in a social or health service setting; have comparable technical and human service training with demonstrated competence and experience managing in a health or human service setting; or, be a registered nurse with two (2) years of supervisory experience (full-time or equivalent) in a social or healthcare setting.

13.12 Volunteers

13.12.1 All volunteers shall be under the supervision of the director/administrator or designated staff person.

13.12.2 The duties of volunteers shall be clearly defined.

13.12.3 The adult day care facility shall maintain a record of volunteer hours/activities and provide appropriate supervision of volunteers.

13.13 Aides/Assistants/Technicians

13.13.1 All aides must meet the following minimum criteria:

13.13.1.1 Completion of an orientation/training program which meets the requirements contained within these regulations; AND,

13.13.1.2 Certification as a nurse aide (CNA); or,

13.13.1.3 Possession of one year of experience in a health care setting; or,

13.13.1.4 Enrollment in a nursing program and completion of a medical surgical clinical practicum.

13.13.2 All aides must pass a competency evaluation test prior to providing unsupervised care to participants in the program.

13.13.3 It is the responsibility of the adult day care program to ensure that aides are proficient to carry out the care assigned in a safe, effective, and efficient manner.

13.14 Staff Training and Development

13.14.1 Prior to assuming job responsibilities, all personnel shall receive training in:

13.14.1.1 Their individual responsibilities in the event of fire, including the location and operation of any fire extinguisher and fire alarm box;

13.14.1.2 Their individual responsibilities in the event of illness or injuries, including the location and use of the first aid emergency supplies;

13.14.1.3 Their individual responsibilities in the event of any emergency;

13.14.1.4 Infection control, body mechanics and first aid; and

13.14.1.5 Special needs of the elderly, persons with cognitive disabilities or persons with other disabilities, including the specific needs of the participants being served.

13.14.2 Ongoing staff development is required to maintain and improve the skills of the adult day care team and should include:

13.14.2.1 The needs of the elderly and persons with disabilities.

13.14.2.2 Assisting participants to achieve maximum self-reliance through re-learning and modifying activities of daily living.

13.14.2.3 Physical restraint and the use of less restrictive alternatives.

13.14.2.4 Maintaining an environment that encourages morale building and self-help.

13.14.2.5 Review of participant care policies and procedures.

13.14.2.6 Prevention and control of infection.

13.14.2.7 Confidentiality of participant information.

13.14.2.8 Rights of participants.

13.14.3 Personnel who are primarily responsible for the direct care of the participants shall attend at least twelve (12) hours annually of staff development activities which shall consist of in-service training programs, workshops, or conferences related to adult day care or specific needs of participants.

13.15 Aide Orientation and Training

13.15.1 An orientation/training program should be based on an instruction plan that includes learning objectives, clinical content and minimum acceptable performance standards.

13.15.2 The orientation program must include at least forty (40) hours of instruction and supervised practicum.

13.15.3 An orientation/training program must include the following:

13.15.3.1 The aide’s role as a member of the adult day care team.

13.15.3.2 Personal care services.

13.15.3.3 Principles of good nutrition.

13.15.3.4 Process of growth, development, and aging.

13.15.3.5 Principles of infection control.

13.15.3.6 Observation, reporting, and documentation of participant status.

13.15.3.7 Maintaining a clean, safe, and healthy environment.

13.15.3.8 Maintaining a least restrictive environment.

13.15.3.9 Verbal/nonverbal communication skills.

13.15.3.10 Principles of body mechanics.

13.16 The adult day care program must maintain sufficient documentation to demonstrate that all requirements of this section have been met.

13.17 An Adult Day Care facility that provides direct healthcare services to persons diagnosed as having Alzheimer’s disease or other forms of dementia shall provide dementia specific training each year to those healthcare providers who must participate in continuing education programs. The mandatory training must include: communicating with persons diagnosed as having Alzheimer’s disease or other forms of dementia; the psychological, social, and physical needs of those persons; and safety measures which need to be taken with those persons. This paragraph shall not apply to persons certified to practice medicine under the Medical Practice Act, Chapter 17 of Title 24 of the Delaware Code.

**History**
- *6 DE Reg. 83 (07/01/02)*
- *6 DE Reg. 83 (07/01/02)*
- *6 DE Reg. 83 (07/01/02)*
- *15 DE Reg. 220 (08/01/11)*
- *25 DE Reg. 776 (02/01/22)*
- *6 DE Reg. 83 (07/01/02)*
- *15 DE Reg. 220 (08/01/11)*
- *25 DE Reg. 776 (02/01/22)*

##### **16 Del. Admin. Code § 3360-14.0** Quality Improvement {#sec-3360-14.0 omnilex-key=us-de-regs-official--title-16--3360-14.0}

14.1 Each adult day care facility shall develop and implement a documented ongoing quality improvement program. The program shall include at a minimum:

14.1.1 An internal monitoring process that tracks performance measures;

14.1.2 A review of the program’s goals and objectives at least annually;

14.1.3 A review of the grievance/complaint process;

14.1.4 A review of actions taken to address identified issues; and

14.1.5 A process to monitor the satisfaction of the participants and/or their representatives with the program.

**History**
- *6 DE Reg. 83 (07/01/02)*
- *6 DE Reg. 83 (07/01/02)*
- *6 DE Reg. 83 (07/01/02)*
- *15 DE Reg. 220 (08/01/11)*
- *25 DE Reg. 776 (02/01/22)*
- *6 DE Reg. 83 (07/01/02)*
- *15 DE Reg. 220 (08/01/11)*
- *25 DE Reg. 776 (02/01/22)*

##### **16 Del. Admin. Code § 3360-15.0** Records And Reports {#sec-3360-15.0 omnilex-key=us-de-regs-official--title-16--3360-15.0}

15.1 There shall be a separate record maintained at the adult day care facility for each participant which shall contain:

15.1.1 Admission record: Including participant’s name, birth date, home address, identification numbers, such as social security, Medicaid, Medicare, date of admission, physician’s name, address and telephone number, diagnosis, names, addresses and telephone numbers of family members, friends, or other designated people to be contacted in the event of illness or an emergency;

15.1.2 A written history and physical examination performed by or under the direction of a physician within 6 months prior to admission;

15.1.3 Results of a medical evaluation or screening test for tuberculosis indicating the absence of active tuberculosis in an infectious stage within 1 year prior to admission;

15.1.4 Application and enrollment forms;

15.1.5 Assessment (initial and reassessments);

15.1.6 Nutritional status assessment as needed;

15.1.7 Individual plan of care (initial and reviews) and revisions;

15.1.8 Signed authorizations for releases of medical information and photos, as appropriate;

15.1.9 Signed authorization for participant to receive emergency medical care if necessary;

15.1.10 Ancillary reports;

15.1.11 Attendance and service records;

15.1.12 Transportation plans;

15.1.13 Where appropriate, medical information sheet; documentation of physicians’ order; treatment, therapy, medication, and professional notes;

15.1.14 Progress notes, chronological and timely, including a monthly assessment of health, functional, and psychosocial status of participants;

15.1.15 Discharge plan;

15.1.16 Current photograph (taken as necessary) depicting an accurate likeness of the participant;

15.1.17 Advance healthcare directive form that complies with DE Code, Title 16, Part II, Chapter 25 or a statement that none has been signed.

15.1.18 A copy of the written agreement between the participant and the adult day care program including any updates made to the original reflecting changes in services or arrangements; and,

15.1.19 Written acknowledgment that the participant or the participant’s representative has been fully informed of the participant’s rights.

15.2 All participants’ medical records shall be maintained in accordance with professional standards.

15.3 All program records shall be available for review by authorized representatives of the Department and to legally authorized persons; otherwise such records shall be held confidential. The consent of the participant or her/his representative if the participant is incapable of making decisions shall be obtained before any personal information is released from her/his records as authorized by these regulations or Delaware law.

15.4 The adult day care facility records shall be retained for a minimum of five (5) years before being destroyed.

15.5 Records shall be protected from loss, damage, and unauthorized use.

**History**
- *6 DE Reg. 83 (07/01/02)*
- *6 DE Reg. 83 (07/01/02)*
- *6 DE Reg. 83 (07/01/02)*
- *15 DE Reg. 220 (08/01/11)*
- *25 DE Reg. 776 (02/01/22)*
- *6 DE Reg. 83 (07/01/02)*
- *15 DE Reg. 220 (08/01/11)*
- *25 DE Reg. 776 (02/01/22)*

##### **16 Del. Admin. Code § 3360-16.0** Infection Prevention and Control Program {#sec-3360-16.0 omnilex-key=us-de-regs-official--title-16--3360-16.0}

16.1 The adult day care facility shall establish and implement an infection prevention and control program which shall be based upon Centers for Disease Control and Prevention and other nationally recognized infection prevention and control guidelines.

16.1.1 The infection prevention and control program must cover all services and all areas of the adult day care facility, including provision of the appropriate personal protective equipment for all participants, staff and visitors.

16.2 The individual designated to lead the adult day care facility's infection prevention and control program must develop and implement a comprehensive plan that includes actions to prevent, identify, and manage infections and communicable diseases. The plan must include mechanisms that result in immediate action to take preventive or corrective measures that improve the adult day care facility's infection control outcomes.

16.3 All adult day care facility staff shall receive orientation at the time of employment and annual in-service education regarding the infection prevention and control program.

16.4 Specific Requirements for COVID-19

16.4.1 Before their start date, all new staff, vendors and volunteers must be tested for COVID-19 in accordance with Division of Public Health guidance.

16.4.2 All staff, vendors and volunteers must be tested for COVID-19 in a manner consistent with Division of Public Health guidance.

16.4.3 The adult day care facility must follow recommendations of the Centers for Disease Control and Prevention and the Division of Public Health regarding the provision of care or services to participants by staff, vendor or volunteer found to be positive for COVID-19 in an infectious stage.

16.5 The adult day care facility shall amend their policies and procedures to include:

16.5.1 Work exclusion and return to work protocols for staff tested positive for COVID-19;

16.5.2 Staff refusals to participate in COVID-19 testing;

16.5.3 Staff refusals to authorize release of testing results or vaccination status to the adult day care facility;

16.5.4 Procedures to obtain staff authorizations for release of laboratory test results to the adult day care facility to inform infection control and prevention strategies; and

16.5.5 Plans to address staffing shortages and adult day care facility demands should a COVID-19 outbreak occur.

**History**
- *6 DE Reg. 83 (07/01/02)*
- *6 DE Reg. 83 (07/01/02)*
- *6 DE Reg. 83 (07/01/02)*
- *15 DE Reg. 220 (08/01/11)*
- *25 DE Reg. 776 (02/01/22)*
- *6 DE Reg. 83 (07/01/02)*
- *15 DE Reg. 220 (08/01/11)*
- *25 DE Reg. 776 (02/01/22)*

##### **16 Del. Admin. Code § 3360-17.0** Severability {#sec-3360-17.0 omnilex-key=us-de-regs-official--title-16--3360-17.0}

In the event any particular clause or section of these Regulations should be declared invalid or unconstitutional by any court of competent jurisdiction, the remaining portions shall remain in full force and effect.

**History**
- *6 DE Reg. 83 (07/01/02)*
- *6 DE Reg. 83 (07/01/02)*
- *6 DE Reg. 83 (07/01/02)*
- *15 DE Reg. 220 (08/01/11)*
- *25 DE Reg. 776 (02/01/22)*
- *6 DE Reg. 83 (07/01/02)*
- *15 DE Reg. 220 (08/01/11)*
- *25 DE Reg. 776 (02/01/22)*

#### **3365** Free Standing Birthing Centers

##### **16 Del. Admin. Code § 3365-1.0** Definitions {#sec-3365-1.0 omnilex-key=us-de-regs-official--title-16--3365-1.0}

1.1 The following words and terms, when used in this regulation, should have the following meaning unless the context clearly indicates otherwise:

“Acute Postpartum Period” means a minimum of two hours following delivery of the placenta and until the patient is clinically stable.

“Administrator” means a person who is delegated the responsibility for the implementation and proper application of policies, programs and services established for the birthing center.

“Birthing Center” means a public or private health facility other than a hospital which is established for the purpose of delivering babies and providing immediate postpartum care. Non-emergency births are planned to occur away from the mother’s usual residence following a documented period of prenatal care for a normal uncomplicated pregnancy which has been determined to be low risk through a formal risk scoring examination.

“Birthing Service” means the prenatal, intrapartum and postpartum care provided for individuals with uncomplicated pregnancy, labor and vaginal birth and newborns during the recovery period. Services provided in a birthing center shall be provided by a licensed physician, certified nurse midwife or certified professional midwife and a registered nurse. Services provided in a birthing center shall be limited in the following manner:

(1) surgical services shall be limited to those normally performed during uncomplicated childbirth, such as episiotomy and repair, and shall not include operative obstetrics or cesarean sections;

(2) surgical repair of a fourth degree laceration is beyond the scope of practice for the midwife;

(3) labor shall not be inhibited, stimulated or augmented with chemical agents during the first or second stage of labor;

(4) systemic analgesia may be administered and local anesthesia for pudendal block and episiotomy repair may be performed;

(5) general and conductive anesthesia shall not be administered at birthing centers;

(6) patients shall not routinely remain in the facility in excess of twenty-four (24) hours.

“Bylaws” means a set of rules adopted by a birthing center for governing the facility’s operation.

“Certified Midwife” means either a Certified Nurse Midwife or a Certified Professional Midwife as defined in these regulations.

“Certified Nurse Midwife” means an individual who is currently licensed to practice nursing as a nurse midwife pursuant to 24 Del.C. Ch. 19.

“Certified Professional Midwife” means an individual who is currently certified to practice midwifery pursuant to 16 Del.C. §122(3)h and who holds a permit from the Division of Public Health.

“Change of Ownership (CHOW)” see “Modification of Ownership and Control (MOC)”.

“Clinical Record” means a written account of all services provided to a patient by the birthing center, as well as other pertinent information necessary to provide care.

“Department” means the Delaware Department of Health and Social Services.

“Governing Body or Other Legal Authority” means the individual, partnership, agency, group, or corporation designated to assume full legal responsibility for the policy determination, management, operation and financial liability of the birthing center.

“Hospital” means a place devoted primarily to the maintenance and operation of facilities for the diagnosis, treatment or care for not less than 24 hours in any week of 4 or more non-related individuals suffering from illness, disease, injury or deformity or a place devoted primarily to providing for not less than 24 hours in any week of obstetrical or other medical or nursing care for 2 or more non-related individuals but does not include sanatoriums, rest homes, nursing homes or boarding homes.

“Immediate Jeopardy” means a crisis situation in which the health and safety of patients is at risk. It is a deficient practice which indicates an inability to furnish safe care and services.

“Legal Entity” means a business organizational structure that is recognized as such by 6 Del.C. or 8 Del.C.

“License” means the document issued by the Department which constitutes the authority to receive patients and perform services included within the scope of these regulations.

“Licensee” means the individual, corporation, or public entity with whom rests the ultimate responsibility for maintaining approved standards for the birthing center.

“Low Risk” means normal, uncomplicated prenatal course as determined by adequate prenatal care and prospects for a normal, uncomplicated birth as defined by reasonable and generally accepted criteria of maternal and fetal health.

“Majority Interest” means the largest percentage of ownership interest.

“Minority Interest” means any percentage of ownership less than the majority interest.

“Modification of Ownership and Control (MOC)” means the sale, purchase, transfer or re-organization of ownership rights.

“Owner” means an individual or legal entity with ownership rights of the facility.

“Ownership” means the state or fact of exclusive possession and control of the facility.

“Ownership Interest” means the percentage of ownership an individual or legal entity possesses.

“Patient” means a pregnant female who plans to deliver away from her usual residence following a documented period of prenatal care for a normal uncomplicated pregnancy which has been determined to be low risk through risk status criteria.

“Physician” means an individual currently licensed as such pursuant to 24 Del.C. Ch. 17.

“Plan of Correction” means a birthing center’s written response to findings of regulatory non-compliance. Plans must adhere to the format specified by the licensing agency, must include acceptable timeframes in which deficiencies will be corrected and must be approved by the licensing agency.

“Recovery Period” means that period of time starting at the birth and ending with the discharge of the patient from the birthing center.

“Registered Nurse” means an individual who is currently licensed to practice nursing pursuant to 24 Del.C. Ch. 19.

“Risk Status Criteria” means

(1) patients are limited to those women who are initially determined to be at low maternity risk and who are evaluated regularly throughout pregnancy to assure that they remain at low risk for a poor pregnancy outcome;

(2) an established written risk assessment system;

(3) determination of general health status and risk assessment by a physician or certified midwife after obtaining a detailed medical history, performing a physical examination and taking into account family circumstances and other social and psychological factors;

(4) acceptance for and continuation of care throughout pregnancy and labor is limited to those women for whom it is appropriate to give birth in a setting where anesthesia is limited to local infiltration of the perineum or a pudendal block and where analgesia is limited;

(5) minimum risk factor criteria shall be applied to all patients prior to acceptance for birthing center services and throughout the pregnancy for continuation of services.

“Survey” means an inspection conducted by a representative of the Department to determine if a licensee is in compliance with Del.C. and this chapter.

“Transfer Agreement” means an agreement with a hospital which has an organized obstetrical services with an obstetrician and a pediatrician on active staff and 24-hour emergency care and cesarean section capability within thirty (30) minutes, providing such service on a continuing basis, stating that said hospital agrees to accept from the birthing center such cases as may need to be referred for whatever reason, and agrees to accept phone consultation for problems that arise in the birthing center.

**History**
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *25 DE Reg. 777 (02/01/22)*
- *12 DE Reg. 235 (08/01/08)*
- *25 DE Reg. 777 (02/01/22)*

##### **16 Del. Admin. Code § 3365-2.0** Licensing Requirements and Procedures {#sec-3365-2.0 omnilex-key=us-de-regs-official--title-16--3365-2.0}

2.1 General Requirements

2.1.1 No person shall establish, conduct, or maintain in this State any birthing center without first obtaining a license from the Department.

2.1.2 Separate licenses are required for facilities maintained in separate locations, even though operated under the same management.

2.1.3 A license is not transferable from person to person or from one location to another.

2.1.4 The license shall be posted in a conspicuous place on the licensed premises.

2.1.5 Any facility that undergoes a change of ownership is required to re-apply as a new facility.

2.2 Application Process

2.2.1 All persons or entities applying for a license shall submit a written statement of intent to the Department describing the services to be offered by the facility and requesting a licensure application from the Department.

2.2.1.1 The issuance of an application form is in no way a guarantee that the completed application will be accepted or that a license will be issued by the Department.

2.2.1.2 Patients shall not be admitted to a facility until a license has been issued.

2.2.1.3 Applicants shall not hold themselves out to the public as being a birthing center until a license has been issued.

2.2.2 Applicants shall submit to the Department the following information:

2.2.2.1 The names, addresses and types of facilities owned or managed by the applicant;

2.2.2.2 Identity of:

2.2.2.2.1 Each officer and director of the corporation if the entity is organized as a corporation;

2.2.2.2.2 Each general partner or managing member if the entity is organized as an unincorporated entity;

2.2.2.2.3 The governing body;

2.2.2.2.4 Proof of not-for-profit status if claiming tax-exempt status; and,

2.2.2.2.5 Any officers/directors, partners, or managing members, or members of a governing body who have a financial interest of five percent (5%) or more in a licensee’s operation or related businesses.

2.2.2.3 Disclosure of any officer, director, partner, employee, managing member, or member of the governing body with a felony criminal record;

2.2.2.4 Name of the individual (administrator) who is responsible for the management of the birthing center;

2.2.2.5 Policy and procedure manuals as requested;

2.2.2.6 A list of management personnel, including qualifications; and,

2.2.2.7 Any other information required by the Department.

2.3 Issuance of Licenses

2.3.1 Probationary license

2.3.1.1 A probationary license shall be granted for a period of one (1) year to all birthing centers:

2.3.1.1.1 Which have completed the blueprint and construction approval processes; and

2.3.1.1.2 Which have completed the application process and whose policies and procedures have demonstrated willingness to comply with the rules and regulations pertaining to birthing center licensure; or

2.3.1.1.3 Which have experienced a change of ownership (CHOW) and have completed the application process demonstrating a willingness to continue to comply with the rules and regulations pertaining to birthing center licensure.

2.3.1.2 All birthing centers shall have an on-site survey during the first year of operation.

2.3.1.3 A probationary license will permit a facility to hire personnel and establish a patient caseload.

2.3.1.4 A probationary license may not be renewed. A birthing center, at the time of an initial on-site survey, must meet the definition of a birthing center as contained within these regulations and must be in operation and caring for patients.

2.3.1.5 Birthing centers which, at the time of an on-site survey, do not meet the definition of a birthing center or which are not in substantial compliance with these regulations will not be granted a license.

2.3.2 Provisional license

2.3.2.1 A provisional license shall be granted, for a period of less than one year, to all birthing centers

2.3.2.1.1 Which are not in substantial compliance with these rules and regulations; or

2.3.2.1.2 Which fail to renew a license within the timeframe prescribed by these regulations.

2.3.2.2 The Department shall designate the conditions and the time period under which a provisional license is issued.

2.3.2.3 A provisional license may not be renewed unless a Plan of Correction for coming into substantial compliance with these rules and regulations, has been approved by the Department and implemented by the birthing center.

2.3.2.4 A license will not be granted pursuant to 2.3.3. after the provisional licensure period to any facility that is not in substantial compliance with these rules and regulations.

2.3.3 License

2.3.3.1 A license shall be granted, for a period of one year (12 months), to all birthing centers which are in substantial compliance with these rules and regulations at the time of application.

2.3.3.2 A license shall be effective for a twelve-month period following date of issue and shall expire one year following the issue date, unless it is: modified to a provisional, suspended or revoked, or surrendered prior to the expiration date.

2.3.3.3 Existing birthing centers must apply for renewal of licensure at least thirty (30) calendar days prior to the expiration date of the license.

2.3.3.4 A license may not be issued to a birthing center which is not in substantial compliance with these regulations or whose deficient practices present an immediate threat to the health and safety of its patients.

2.4 Disciplinary proceedings

2.4.1 The Department may impose any of the following sanctions (subsection 2.4.2 of this section) singly or in combination when it finds a licensee or former licensee is guilty of any offense described herein:

2.4.1.1 Violated any of these regulations;

2.4.1.2 Failed to submit a reasonable timetable for correction of deficiencies;

2.4.1.3 Exhibited a pattern of cyclical deficiencies which extends over a period of two or more years;

2.4.1.4 Failed to correct deficiencies in accordance with a timetable submitted by the applicant and agreed upon by the Department;

2.4.1.5 Engaged in any conduct or practices detrimental to the welfare of the patients;

2.4.1.6 Exhibited incompetence, negligence, or misconduct in operating the birthing center or in providing services to patients;

2.4.1.7 Mistreated or abused patients cared for by the birthing center; or

2.4.1.8 Refused to allow the Department access to the facility or records for the purpose of conducting surveys as deemed necessary by the Department.

2.4.2 Disciplinary sanctions:

2.4.2.1 Permanently revoke a license.

2.4.2.2 Suspend a license.

2.4.2.3 Issue a letter of reprimand.

2.4.2.4 Place a licensee on provisional status and require the licensee to:

2.4.2.4.1 Report regularly to the Department upon the matters which are the basis of the provisional status.

2.4.2.4.2 Limit practice to those areas prescribed by the Department.

2.4.2.4.3 Suspend all admissions.

2.4.2.5 Refuse a license.

2.4.2.6 Refuse to renew a license.

2.4.2.7 Otherwise discipline.

2.4.3 Imposition of Disciplinary Action

2.4.3.1 Before any disciplinary action under this chapter is taken (except as authorized by 2.4.4):

2.4.3.1.1 The Department shall give twenty (20) calendar days written notice to the holder of the license, setting forth the reasons for the determination.

2.4.3.1.2 The suspension or revocation shall become final twenty (20) calendar days after the mailing of the notice unless the licensee, within such twenty (20) calendar day period, shall give written notice of the facility’s desire for a hearing.

2.4.3.1.3 If the licensee gives such notice, the facility shall be given a hearing before the Secretary of the Department or her/his designee and may present such evidence as may be proper.

2.4.3.1.4 The Secretary of the Department or her/his designee shall make a determination based upon the evidence presented.

2.4.3.1.5 A written copy of the determination and the reasons upon which it is based shall be sent to the facility.

2.4.3.1.6 The decision shall become final twenty (20) calendar days after the mailing of the determination letter unless the licensee, within the twenty (20) calendar day period, appeals the decision to the appropriate court of the State.

2.4.4 Order to immediately suspend a license

2.4.4.1 In the event the Department identifies activities which the Department determines present an immediate or imminent danger to the public health, welfare and safety requiring emergency action, the Department may issue an order temporarily suspending the licensee's license, pending a final hearing on the complaint. No order temporarily suspending a license shall be issued by the Department, with less than 24 hours prior written or oral notice to the licensee or the licensee's attorney so that the licensee may be heard in opposition to the proposed suspension. An order of temporary suspension under this section shall remain in effect for a period not longer than 60 calendar days from the date of the issuance of said order, unless the suspended licensee requests a continuance of the date for the final hearing before the Department. If a continuance is requested, the order of temporary suspension shall remain in effect until the Department has rendered a decision after the final hearing.

2.4.4.2 The licensee, whose license has been temporarily suspended, shall be notified forthwith in writing. Notification shall consist of a copy of the deficiency report and the order of temporary suspension pending a hearing and shall be personally served upon the licensee or sent by certified mail, return receipt requested, to the licensee's last known address.

2.4.4.3 A licensee whose license has been temporarily suspended pursuant to this section may request an expedited hearing. The Department shall schedule the hearing on an expedited basis provided that the Department receives the licensee's request for an expedited hearing within 5 calendar days from the date on which the licensee received notification of the Department's decision to temporarily suspend the licensee's license.

2.4.4.4 As soon as possible, but in no event later than 60 calendar days after the issuance of the order of temporary suspension, the Department shall convene for a hearing on the reasons for suspension. In the event that a licensee, in a timely manner, requests an expedited hearing, the Department shall convene within 15 calendar days of the receipt by the Department of such a request and shall render a decision within 30 calendar days.

2.4.4.5 In no event shall an order of temporary suspension remain in effect for longer than 60 calendar days unless the suspended licensee requests an extension of the order of temporary suspension pending a final decision of the Department. Upon a final decision of the Department, the order of temporary suspension shall be vacated in favor of the disciplinary action ordered by the Department.

2.4.5 Termination of license

2.4.5.1 Termination of a license to provide services as a birthing center occurs secondary to:

2.4.5.1.1 Revocation of a license or the voluntary surrender of a license in avoidance of revocation action.

2.4.5.2 Termination of rights to provide services extends to:

2.4.5.2.1 Facility;

2.4.5.2.2 Owner(s);

2.4.5.2.3 Officers/Directors, partners, managing members, or members of a governing body who have a financial interest of five percent (5%) or more in the birthing center; and

2.4.5.2.4 Corporation officers.

2.5 Modification of Ownership and Control (MOC)

2.5.1 Any proposed MOC must be reported to the Department a minimum of thirty (30) calendar days prior to the change.

2.5.2 A MOC voids the current license in possession of the facility.

2.5.3 A MOC may include but is not limited to:

2.5.3.1 Transfer of full ownership rights to a new owner;

2.5.3.2 Transfer of the majority interest to a new owner;

2.5.3.3 Transfer of ownership interests that result in the owner with the majority interest becoming a minority interest owner;

2.5.3.4 Transfer or re-organization that results in an additional majority interest that is equal in ownership rights; or,

2.5.3.5 Transfer resulting in a measurable impact upon the operational control of the facility.

2.6 Fees

2.6.1 Fees shall be in accordance with 16 Del.C. §122 (3)p.

2.7 Inspection

2.7.1 A representative of the Department shall periodically inspect every birthing center for which a license has been issued under this chapter. Inspections by authorized representatives of the Department may occur at any time and may be scheduled or unannounced.

2.8 Notice to Patients

2.8.1 The birthing center shall notify each patient, the patient's attending physician (as appropriate) and any third-party payers at least thirty (30) calendar days before the voluntary surrender of its license, or as directed under an order of denial, revocation, or suspension of license issued by the Department.

**History**
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *25 DE Reg. 777 (02/01/22)*
- *12 DE Reg. 235 (08/01/08)*
- *25 DE Reg. 777 (02/01/22)*

##### **16 Del. Admin. Code § 3365-3.0** General Requirements {#sec-3365-3.0 omnilex-key=us-de-regs-official--title-16--3365-3.0}

3.1 The birthing center shall not admit, nor continue to care for, patients whose needs cannot be met by the facility.

3.1.1 A physician or certified midwife shall make a determination of general health status and risk factors after obtaining a detailed medical history, performing a physical examination and taking into account family circumstances and other social and psychological factors.

3.1.2 Acceptance for and continuation of care throughout pregnancy and labor is limited to those women for whom it is appropriate to give birth in a setting where anesthesia is limited to local infiltration of the perineum or a pudendal block and where analgesia is limited.

3.2 The birthing center shall utilize an established written risk assessment system.

3.2.1 Minimum risk factor criteria shall be applied to all patients prior to acceptance for birthing center services and throughout the pregnancy for continuation of services.

3.2.2 Patients with any minimum risk factors, including but not limited to those listed in 3.2.3, shall be referred to a physician for continuing maternity care and hospital delivery.

3.2.3 Minimum risk factors include but may not be limited to:

3.2.3.1 Patient is less than 16 years of age.

3.2.3.2 Major medical problems including but not limited to:

3.2.3.2.1 Chronic hypertension;

3.2.3.2.2 Chronic heart disease;

3.2.3.2.3 Pulmonary embolus;

3.2.3.2.4 Congenital heart defects;

3.2.3.2.5 Severe renal disease;

3.2.3.2.6 Lupus erythematosus;

3.2.3.2.7 Drug or alcohol addiction;

3.2.3.2.8 Required use of anticonvulsant drugs;

3.2.3.2.9 Bleeding disorder or hemolytic disease;

3.2.3.2.10 Paraplegia/quadriplegia;

3.2.3.2.11 Diabetes mellitus;

3.2.3.2.12 Cognitive impairment that would interfere with the ability to follow directions;

3.2.3.2.13 Morbid obesity;

3.2.3.2.14 Active genital herpes, syphilis or HIV positive;

3.2.3.2.15 The need for general or conduction anesthesia;

3.2.3.2.16 The need for a caesarian section; or

3.2.3.2.17 Serious congenital anomaly in a previous birth whose recurrence cannot be ruled out by antenatal evaluation.

3.2.3.3 Previous history of significant obstetrical complications including but not limited to:

3.2.3.3.1 Rh sensitization;

3.2.3.3.2 Previous uterine wall surgery including cesarean section;

3.2.3.3.3 Five or more term pregnancies with other risk factors;

3.2.3.3.4 Nullipara of greater than 40 years of age with other risk factors;

3.2.3.3.5 Multipara over 45 years of age with other risk factors; or

3.2.3.3.6 Previous placenta abruption.

3.2.3.4 Significant signs or symptoms of:

3 2.3.4.1 Hypertension;

3.2.3.4.2 Toxemia;

3.2.3.4.3 Polyhydramnios or oligohydramnios;

3.2.3.4.4 Abruption placenta;

3.2.3.4.5 Chorioamnionitis;

3.2.3.4.6 Malformed fetus;

3.2.3.4.7 Fetal distress;

3.2.3.4.8 Multiple gestation;

3.2.3.4.9 Intrauterine growth retardation or macrosomia;

3.2.3.4.10 Thrombophlebitis; or

3.2.3.4.11 Pyelonephritis.

3.3 All records maintained by the birthing center shall at all times be open to inspection by the authorized representatives of the Department.

3.4 No policies shall be adopted by the birthing center which are in conflict with these regulations.

3.5 The birthing center shall establish written policies regarding the rights and responsibilities of patients.

3.6 The birthing center shall establish policies and procedures that address the handling and documentation of incidents, accidents and medical emergencies.

3.7 Reports of incidents, accidents and medical emergencies shall be kept on file at the facility.

3.8 The birthing center shall establish policies which control the exposure of patients and staff to persons with communicable diseases.

3.9 The birthing center shall establish policies which require reporting of all reportable communicable diseases to the Department.

3.10 A procedure, approved by the Department and including the patients and families right to report concerns/complaints to the Department at a telephone number established for that purpose, shall be established to enable patients and their families to have their concerns addressed without fear of reprisal.

3.11 The birthing center shall advise the Department in writing within fifteen (15) calendar days following any change in the designation of the director/administrator or other administrative personnel within the facility.

3.12 The birthing center may not establish separate facilities without first contacting and receiving approval from the Department.

3.13 The birthing center may contract for services to be provided to its patients. Individuals providing services under contract must meet the same requirements as those persons employed directly by the facility.

3.14 The director/designee shall be available at all times during the operating hours of the birthing center.

3.15 The birthing center must permit photocopying of any records or other information by, or on behalf of authorized representatives of the Department, as necessary to determine or verify compliance with these regulations.

3.16 Report of Major Adverse Incidents

3.16.1 The facility must report all major adverse incidents involving a patient to the Department within forty-eight (48) hours in addition to other reporting requirements required by law.

3.16.2 A major adverse incident includes but is not limited to:

3.16.2.1 Suspected abuse, neglect, mistreatment, financial exploitation of a patient, solicitation or harassment;

3.16.2.2 An accident that causes injury to a patient; and

3.16.2.3 The unexpected death of a patient.

3.16.3 Major adverse incidents must be investigated by the facility and a report must be generated.

3.16.4 A complete report will be forwarded to the Department within thirty (30) calendar days of occurrence or of the date that the facility first became aware of the incident.

**History**
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *25 DE Reg. 777 (02/01/22)*
- *12 DE Reg. 235 (08/01/08)*
- *25 DE Reg. 777 (02/01/22)*

##### **16 Del. Admin. Code § 3365-4.0** Governing Body {#sec-3365-4.0 omnilex-key=us-de-regs-official--title-16--3365-4.0}

4.1 Each birthing center shall have an organized governing body (governing authority, owner or person(s) designated by the owner).

4.2 The governing body shall be ultimately responsible for:

4.2.1 The management and control of the facility;

4.2.2 The assurance of quality care and services;

4.2.3 Compliance with all federal, state and local laws and regulations;

4.2.4 Adoption of written policies and procedures which describe the functions and services of the birthing center;

4.2.5 Providing a sufficient number of appropriately qualified personnel;

4.2.6 Providing physical resources and equipment, supplies and services for the provision of safe, effective and efficient delivery of services for normal uncomplicated pregnancies to low risk mothers;

4.2.7 Developing an organizational structure establishing lines of authority and responsibility;

4.2.8 Appointing a qualified administrator;

4.2.9 Appointing members of the clinical staff, ensuring their competence and delineating their clinical privileges;

4.2.10 Conducting meetings, when the governing body is more than one person, at least annually and maintaining written minutes of the meeting(s);

4.2.11 Annual review and evaluation of the birthing center policies and services; and

4.2.12 Other relevant health and safety requirements.\

**History**
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *25 DE Reg. 777 (02/01/22)*
- *12 DE Reg. 235 (08/01/08)*
- *25 DE Reg. 777 (02/01/22)*

##### **16 Del. Admin. Code § 3365-5.0** Administration/Personnel {#sec-3365-5.0 omnilex-key=us-de-regs-official--title-16--3365-5.0}

5.1 Administrator

5.1.1 There shall be a full-time facility administrator.

5.1.2 The administrator shall be responsible for implementing the policies adopted by the governing body.

5.1.3 The administrator shall have the overall authority and responsibility for the daily operation and management of the facility.

5.1.4 The administrator shall designate, in writing, a qualified person to act in her/his behalf during her/his absence.

5.1.5 The administrator shall review facility policies and procedures at least annually and report to the governing body on the review.

5.1.6 The authority, duties and responsibilities of the administrator shall be defined in writing and shall include but not be limited to:

5.1.6.1 Interpretation and execution of the policies of the facility;

5.1.6.2 Program planning, budgeting, management and evaluation;

5.1.6.3 Maintenance of the facility's compliance with licensure regulations and standards;

5.1.6.4 Preparation and submission of required reports;

5.1.6.5 Distribution of a written plan for the delegation of administrative responsibilities and functions in the absence of the director;

5.1.6.6 Documentation of complaints relating to the conduct or actions by licensed health care professionals and action taken secondary to the complaints; and

5.1.6.7 Conducting or supervising the resolution of complaints received from patients in the delivery of care or services received at the facility.

5.2 Clinical Director

5.2.1 The clinical director shall be responsible for implementing, coordinating and assuring quality of patient care services.

5.2.2 The clinical director shall:

5.2.2.1 Be currently licensed as a physician or nurse midwife; and

5.2.2.2 Have training and expertise in obstetric and newborn services to ensure adequate supervision of patient care services.

5.2.3 The authority, duties and responsibilities of the clinical director shall be defined in writing and shall include but not be limited to:

5.2.3.1 Review and update of facility policies, procedures and protocols;

5.2.3.2 Review and evaluate clinical staff privileges;

5.2.3.3 Recommend, to the governing body, names of qualified personnel to perform approved procedures and the corresponding clinical staff privileges to be granted;

5.2.3.4 Coordinate, direct and evaluate clinical operations of the facility;

5.2.3.5 Evaluate and recommend to the administrator the type and amount of equipment needed in the facility;

5.2.3.6 Ensure that qualified staff are on the premises when patients are in the facility;

5.2.3.7 Ensure clinical staff documentation is recorded immediately and reflects a description of care given;

5.2.3.8 Ensure that planned birthing center services are within the scope of privileges granted to the clinical staff;

5.2.3.9 Ensure the accuracy of public education information materials and activities in relation to pregnancy and birth, mother and infant care, and the facility; and,

5.2.3.10 Recommend to the administrator appropriate remedial action and disciplinary action, when necessary, to correct violations of clinical protocols.

5.3 Clinical Staff

5.3.1 There shall be a single organized professional staff consisting of physicians, nurse midwives or certified professional midwives and registered nurses.

5.3.2 The organized professional staff shall have the overall responsibility for the quality of all clinical care provided to patients.

5.3.3 There shall be sufficient, qualified personnel available to perform the services offered by the facility.

5.3.4 All clinical staff who perform services in the facility who are required by state law to be licensed, registered or certified shall have valid licenses, registrations or certificates.

5.3.5 A physician certified by the American Board of Obstetrics and Gynecology or who is qualified and authorized by training and experience in obstetrics and gynecology shall be immediately available by telephone twenty-four hours a day.

5.3.6 Each physician providing services for the facility must demonstrate hospital admitting privileges for patients who develop complications.

5.3.7 Each certified mid-wife (nurse or professional) providing services for the facility must provide proof of a back-up agreement with a physician who will accept consultation calls and referrals twenty-four (24) hours a day, seven (7) days a week.

5.3.7.1 The back-up physician must demonstrate hospital admitting privileges for patients who develop complications.

5.3.8 The facility shall establish a job description for each classification of position, which clearly delineates qualifications, duties, authority, and responsibilities inherent in each position.

5.3.9 A physician or certified mid-wife shall be present at each birth and until the woman and newborn are stable postpartum.

5.3.9.1 A second person in addition to the above, who is a registered nurse with adult and infant resuscitation skills, shall be present during the delivery.

5.3.10 A certified mid-wife or registered nurse with adult and infant resuscitation skills shall be present at the facility at all times when a patient is present.

5.3.11 Clinical staff shall comply with facility policies and procedures.

5.3.12 Clinical staff shall comply with applicable professional practice standards.

5.4 Written Policies

5.4.1 Policy manuals shall be prepared and followed which outline the procedures and practices of the facility.

5.4.2 There shall be written policies regarding the screening criteria, risk status criteria and procedures for identifying:

5.4.2.1 Low-risk patients who shall be eligible for birthing services offered by the birthing center, and

5.4.2.2 Individuals who shall be ineligible for birthing services at the birthing center.

5.4.3 There shall be written policies regarding:

5.4.3.1 Identification and transfer of patients who, during the course of pregnancy, are determined to be ineligible, and

5.4.3.2 Identification and transfer of patients who, during the course of labor or recovery, are determined to be ineligible for continued care in the birthing center.

5.4.4 There shall be written policies for:

5.4.4.1 Consultation, back-up services, transfer and transport of a newborn or maternal patient to a hospital;

5.4.4.2 Routine and emergency care of both the maternal and the fetus or newborn patient until completion of care by the birthing center either through completion of the care program or through transfer to another level of care;

5.4.4.3 Care following discharge for both the patient and the newborn;

5.4.4.4 The provision of education to patients, family and support persons in childbirth and newborn care;

5.4.4.5 Birth reporting requirements; and

5.4.4.6 Infection control.

5.4.5 There shall be written personnel policies, including but not limited to:

5.4.5.1 Pre-employment requirements;

5.4.5.2 Position descriptions;

5.4.5.3 Orientation of all new employees;

5.4.5.4 Inservice education;

5.4.5.5 Annual performance review and competency; and

5.4.5.6 The process of appointment to the professional staff whereby it can satisfactorily be determined that the individual is appropriately licensed and qualified for the privileges and responsibilities to be given.

5.4.6 There shall be written policies designed to enhance safety within the facility and on its premises and to minimize hazards to patients, staff and visitors including:

5.4.6.1 Rules and practices pertaining to personnel, equipment, liquids, drugs and hazards to children including but not limited to electrical outlets, unsafe toys, stairs, storage cabinets, kitchen cabinets and outdoor areas;

5.4.6.2 Reporting and investigation of accidental events and corrective action taken;

5.4.6.3 Dissemination of safety-related information to employees and users of the facility;

5.4.6.4 Syringe and needle storage, handling and disposal;

5.4.6.5 Storage and handling of drugs and biologicals;

5.4.6.6 A preventative maintenance program which is implemented to keep the entire facility and equipment in good repair and to provide for the safety, welfare and comfort of the occupants of the building(s);

5.4.6.7 Housekeeping;

5.4.6.8 Safe storage of cleaning materials and pesticides and other potentially toxic materials;

5.4.6.9 Safe storage and handling of soiled linen and clothing;

5.4.6.10 Pest control; and

5.4.6.11 Waste disposal.

5.4.7 Policies shall be reviewed and dated annually and revised as necessary.

5.4.8 Policies shall be made available to representatives of the Department upon request.

5.5 Personnel Records

5.5.1 Records of each employee/contractor shall be kept current and available upon request by authorized representatives of the Department.

5.5.2 The facility shall maintain individual personnel records which shall contain at least:

5.5.2.1 Written verification of compliance with pre-employment requirements;

5.5.2.2 Documentation of participation in a formal orientation program to the facility;

5.5.2.3 Copies of professional licenses, registrations or certifications;

5.5.2.4 Documentation of competence;

5.5.2.5 Educational preparation and work history;

5.5.2.6 Written performance reviews (annually); and

5.5.2.7 A letter of appointment specifying conditions of employment.

5.6 Employment Practices

5.6.1 Health History

5.6.1.1 All new personnel shall be required to have a physical examination prior to providing care.

5.6.1.1.1 The physical examination must have been completed within 3 months prior to initial employment.

5.6.1.1.2 A copy of the physical examination shall be maintained in individual files.

5.6.1.2 Minimum requirements for tuberculosis (TB) testing are those currently recommended by the Centers for Disease Control and Prevention of the U.S. Department of Health and Human Services. Testing must be completed within ninety (90) calendar days prior to provision of birthing center services and annually thereafter.

5.6.1.2.1 No person found to have active TB in an infectious stage shall be permitted to give care or service to patients.

5.6.1.2.2 Any person having a positive skin test but a negative chest X-ray must complete a statement annually attesting that they have experienced no symptoms which may indicate active TB infection.

5.6.1.2.3 A report of all TB test results and all attestation statements shall be on file.

5.6.2 It is the responsibility of the birthing center to ensure that personnel are proficient to carry out the care assigned in a safe, effective and efficient manner.

5.6.3 Any individual who cannot adequately perform her/his duties or who may jeopardize the health or safety of the patients shall be relieved of his duties and removed from the facility until such time as the condition is resolved. This includes infections of a temporary nature.

**History**
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *25 DE Reg. 777 (02/01/22)*
- *12 DE Reg. 235 (08/01/08)*
- *25 DE Reg. 777 (02/01/22)*

##### **16 Del. Admin. Code § 3365-6.0** Patient Care {#sec-3365-6.0 omnilex-key=us-de-regs-official--title-16--3365-6.0}

6.1 Admissions

6.1.1 Only those mothers who demonstrate the potential for a normal uncomplicated course of pregnancy and labor may be accepted for childbirth at the facility.

6.1.1.1 The facility must utilize a written risk assessment system to determine risk status criteria.

6.1.1.2 Those mothers determined to be at risk as defined in Sec. 3.2 must be referred to a physician for care.

6.1.2 All patients admitted to the facility shall be under the direct care of a member of the clinical staff and agree to remain at the facility not less than four (4) hours postpartum.

6.1.3 The facility and the patient shall have a written agreement for services which shall include:

6.1.3.1 An explanation of the services available;

6.1.3.2 An explanation of services not available, including types of anesthesia;

6.1.3.3 The location (distance and driving time) of the nearest hospital providing obstetrical/gynecological/pediatric services; and

6.1.3.4 A statement of charges for services.

6.1.4 Every woman seeking birthing center services shall have an initial assessment by a professional member of the staff to determine eligibility for admission.

6.2 Prenatal Care

6.2.1 A childbirth education program shall be provided or made available by the birthing center. The program shall include but not be limited to:

6.2.1.1 Prenatal care and its outcome;

6.2.1.2 Care of the newborn;

6.2.1.3 Instruction regarding labor and delivery; and

6.2.1.4 Preparation for participation in the childbirth process.

6.2.2 Prenatal care shall be in accordance with acceptable standards.

6.2.3 When, in the course of prenatal care, risk factors are identified which preclude childbirth at the facility, the patient shall be referred for care to a qualified physician.

6.2.4 Prenatal visits shall be scheduled:

6.2.4.1 At least every four (4) weeks until the twenty-eighth (28th) week;

6.2.4.2 At least every two (2) weeks between the twenty-eighth (28th) week and the thirty-sixth (36th) week; and

6.2.4.3 At least every week between the thirty-sixth (36th) week and delivery.

6.3 Intrapartum Care

6.3.1 A professional staff member must be present and available to the patient at all times during her stay at the facility.

6.3.2 The professional staff shall monitor the progress of labor and the condition of the patient and fetus at sufficient frequent intervals to identify abnormalities or complications at the earliest possible time.

6.3.3 If complications occur in the course of labor and delivery, it is the responsibility of the professional staff to arrange for the patient to be transferred to the hospital.

6.3.4 The family or support persons shall be instructed as needed to assist the patient during labor and delivery.

6.3.5 Interventions shall be limited to those required to accomplish a vaginal delivery.

6.3.6 Labor shall not be inhibited, stimulated or augmented with chemical agents.

6.3.7 No surgical procedures shall be performed except episiotomy, repair of episiotomy or laceration, or circumcision.

6.3.8 Systemic analgesics and local anesthesia may be administered under the following conditions:

6.3.8.1 The professional staff member who administers the systemic analgesic is legally authorized to do so;

6.3.8.2 The dosage and drug are specifically noted in the protocols for clinical services; and

6.3.8.3 The use of such drugs is in conformance with the policies and procedures of the facility and with national standards.

6.3.9 General and conduction anesthesia shall not be administered.

6.4 Postpartum Care

6.4.1 The patient shall remain at the facility a minimum of four (4) hours postpartum after a normal uncomplicated birth.

6.4.2 Postpartum care shall be delivered in accordance with acceptable professional standards and legal requirements.

6.4.3 The newborn shall be referred to a physician or a hospital for any condition requiring medical care.

6.4.4 The condition of the patient shall be monitored frequently to detect signs of hemorrhage or other complications requiring prompt transfer to a hospital.

6.4.5 The patient shall be counseled regarding breast feeding, perineal care, family planning, signs of common complications, activities and exercise, sexual relations, care and feeding of the newborn and changing family relationships.

6.4.6 A member of the facility's professional staff must be accessible to patients by telephone, twenty-four (24) hours a day.

6.4.7 The facility must make provisions for appropriate follow-up care for the patient and newborn after discharge.

6.5 Management of Emergencies

6.5.1 Criteria shall be established to determine risk status which requires medical consultation or transfer to a hospital and shall include but not be limited to:

6.5.1.1 Premature labor (occurring at less than thirty-seven (37) weeks gestation);

6.5.1.2 Development of hypertension or pre-eclampsia;

6.5.1.3 Non-vertex presentation

6.5.1.4 Failure to progress in labor

6.5.1.5 Evidence of an infectious process;

6.5.1.6 Suspected placenta previa or abruption;

6.5.1.7 Hemorrhage of greater than 500 cc of blood;

6.5.1.8 Premature rupture of the membranes (occurring within a timeframe agreed upon by the certified midwife and back-up physician in their collaborative agreement);

6.5.1.9 Suspected congenital anomaly;

6.5.1.10 Anemia consisting of less than ten (10) grams of hemoglobin per one hundred (100) milliliters of blood or thirty (30) percent hematocrit;

6.5.1.11 Persistent fetal tachycardia (heart rate greater than 160 beats per minute), repetitive fetal bradycardia (heart rate less than 120 beats per minute) or undiagnosed abnormalities of the fetal heart tones;

6.5.1.12 Rising antibody titre of any type that is known to affect fetal well-being;

6.5.1.13 Excessive need for analgesia during labor, or for anesthesia other than pudendal or local; or

6.5.1.14 Persistent hypothermia in the newborn.

6.5.2 Criteria shall be established to determine risk status which requires immediate emergency transfer to a hospital and shall include but not be limited to:

6.5.2.1 Prolapsed cord;

6.5.2.2 Uncontrolled hemorrhage;

6.5.2.3 Need for transfusion;

6.5.2.4 Placenta abruption;

6.5.2.5 Retained placenta greater than sixty (60) minutes;

6.5.2.6 Convulsions;

6.5.2.7 Thick meconium staining at the time of membrane rupture;

6.5.2.8 Apgar score of seven (7) or less at five (5) minutes;

6.5.2.9 Fetal heart rate of ninety (90) or less beats per minute for three (3) minutes;

6.5.2.10 Major anomaly of the newborn;

6.5.2.11 Respiratory distress in the newborn;

6.5.2.12 Newborn weight less than 2500 grams;

6.5.2.13 Newborn need for oxygen beyond five (5) minutes; or

6.5.2.14 Signs of prematurity.

6.6 Food Service

6.6.1 The facility may provide patients and families with nutritious liquids and snacks as needed.

6.6.2 When the facility policy allows for the preparation and/or storage of food brought in by the patients or families:

6.6.2.1 There shall be refrigerator able to maintain cold foods at a temperature of 45° Fahrenheit or lower;

6.6.2.2 There shall be a stove and/or a microwave oven;

6.6.2.3 There shall be dry storage and counter space; and

6.6.2.4 There shall be a dishwashing machine and/or a sink.

6.6.3 Food may not be stored together with medications requiring refrigeration.

6.6.4 All refrigerated food items must be labeled and dated.

6.6.5 If applicable, the facility's food services will be subject to the food establishment requirements.

6.7 Pharmaceutical Service

6.7.1 Medicines and drugs maintained at the facility shall be properly stored and secured in specifically designated cabinets, closets, drawers or storerooms.

6.7.2 Only authorized persons shall have access to storage enclosures.

6.7.3 Controlled drugs shall be stored in accordance with state and federal laws.

6.7.3.1 Records shall be kept on the receipt and disposition of all controlled substances.

6.7.4 Medicines and drugs shall not be administered to patients unless ordered by an independent licensed practitioner with prescriptive authority.

6.7.4.1 Orders for medicines and drugs must be in writing and must be signed by the prescribing licensed practitioner.

6.7.4.1.1 Verbal and telephone orders may only be received by a registered nurse, midwife, physician or pharmacist.

6.7.4.1.2 All verbal and telephone orders must be countersigned by the ordering practitioner within forty-eight (48) hours of the order.

6.7.4.2 Pain control should depend primarily on close emotional support and adequate preparation for the birth experience.

6.7.5 All medicines and drugs must be properly labeled according to state and federal law.

6.7.6 Medicines and drugs requiring refrigeration must be stored and secured in a refrigerator for that purpose.

6.7.7 Medicines and drugs shall be administered only by persons authorized and licensed to administer medicines and drugs.

6.7.8 When the facility maintains its own pharmaceutical services, it shall comply with applicable state laws and regulations.

6.8 Laboratory Service

6.8.1 Clinical pathology services shall be available as required by the needs of the patients and as determined by the facility staff.

6.8.2 The facility may either provide a clinical laboratory or make contractual arrangement with an outside laboratory.

**History**
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *25 DE Reg. 777 (02/01/22)*
- *12 DE Reg. 235 (08/01/08)*
- *25 DE Reg. 777 (02/01/22)*

##### **16 Del. Admin. Code § 3365-7.0** Clinical Record {#sec-3365-7.0 omnilex-key=us-de-regs-official--title-16--3365-7.0}

7.1 A clinical record shall be maintained for every patient and newborn admitted to and cared for in the facility.

7.2 A person knowledgeable in the management of clinical records shall be responsible for the proper administration and functioning of the clinical records section.

7.3 There shall be an identified locked area for clinical record storage at the facility.

7.4 Clinical records shall be protected from loss, damage and unauthorized use.

7.5 The facility shall ensure that each clinical record is treated with confidentiality and is maintained according to professional standards of practice.

7.6 The clinical records shall contain sufficient accurate documentation of significant clinical information pertaining to the patient and newborn to justify the diagnosis and warrant the treatment and end results including but not limited to:

7.6.1 Complete patient identification including a unique identification number;

7.6.2 Admission date and time;

7.6.3 Discharge date and time;

7.6.4 Admission diagnosis;

7.6.5 Medical history;

7.6.6 Physical examination completed prior to the birth;

7.6.7 Labor and delivery record;

7.6.8 Diagnostic tests, laboratory and x-ray reports when appropriate;

7.6.9 Progress notes;

7.6.10 Properly executed informed consent;

7.6.11 Record of anesthesia, analgesia and medications administered during the course of labor, delivery and postpartum;

7.6.12 Condition upon discharge;

7.6.13 Final diagnosis;

7.6.14 Instructions for follow-up care of the patient and newborn;

7.6.15 Prenatal care record including at least:

7.6.15.1 Hemoglobin/Hematocrit;

7.6.15.2 Urine screening;

7.6.15.3 Prenatal blood serology;

7.6.15.4 RH factor determination;

7.6.15.5 Rubella titre; and

7.6.15.6 Prenatal instructions.

7.7 Newborn clinical records shall be maintained separately and shall include:

7.7.1 Date and hour of birth;

7.7.2 Birth weight;

7.7.3 Birth length;

7.7.4 Period of gestation;

7.7.5 Sex;

7.7.6 Condition of newborn on delivery, including APGAR rating and any resuscitative measures taken;

7.7.7 Mother's name and unique identification number;

7.7.8 Record of:

7.7.8.1 Ophthalmic prophylaxis;

7.7.8.2 Administration of RH immune globulin as appropriate;

7.7.8.3 Genetic screening; and

7.7.8.4 Fetal monitoring.

7.7.9 Birth and discharge physical examination;

7.7.10 Copy of birth certificate; and

7.7.11 Instructions for follow-up care.

7.8 All entries in the clinical record must be signed and dated by the responsible person in accordance with the facility's policies and procedures.

7.9 Computerized clinical records must be printed by the facility as requested by authorized representatives of the Department.

7.10 The facility records shall be retained in a retrievable form until destroyed.

7.10.1 Records of adults (18 years of age and older) shall be retained for a minimum of six (6) years after the last date of service before being destroyed.

7.10.2 Records of minors (less than 18 years of age) shall be retained for a minimum of six (6) years after the patient reaches eighteen (18) years of age.

7.10.3 The facility must establish procedures for the notification to patients regarding the pending destruction of clinical records.

7.10.4 All records must be disposed of by shredding, burning, or other similar protective measure in order to preserve the patients' rights of confidentiality.

7.10.5 Documentation of record destruction must be maintained by the facility.

7.11 The facility must develop acceptable policies for authentication of any computerized records.

**History**
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *25 DE Reg. 777 (02/01/22)*
- *12 DE Reg. 235 (08/01/08)*
- *25 DE Reg. 777 (02/01/22)*

##### **16 Del. Admin. Code § 3365-8.0** Physical Environment {#sec-3365-8.0 omnilex-key=us-de-regs-official--title-16--3365-8.0}

8.1 Laundry and Linens

8.1.1 An adequate supply of clean linen or disposable materials shall be maintained.

8.1.2 Clean linen shall be stored, handled and transported to prevent contamination.

8.1.3 Linens shall be maintained in good repair.

8.1.4 Soiled linen shall be handled, transported, stored and processed in a manner to prevent leakage and the spread of infection.

8.1.5 There shall be distinct areas for the storage and handling of clean and soiled linens.

8.1.6 Soiled linen not processed on a daily basis must be stored in a separate properly ventilated storage area.

8.1.7 Soiled linen must be removed from the birth room after each procedure.

8.1.8 Carts used to transport soiled linen must be constructed of impervious materials and must be cleaned and disinfected after each use.

8.1.9 Laundry processed on-site:

8.1.9.1 The laundry processing area shall be arranged to allow for an orderly progressive flow of work from the soiled to the clean area.

8.1.9.2 The temperature of water during the washing process shall be controlled to provide a minimum temperature of 165° Fahrenheit for 25 minutes or 130° Fahrenheit if the soap/detergent supplier will verify that their products will work effectively at that lower temperature. A label indicating same shall be affixed to the laundry machine.

8.1.10 Laundry processed off-site:

8.1.10.1 The facility must have a contract with a commercial or hospital laundry.

8.1.10.2 Clean linens returned to the facility must be completely wrapped or covered to protect against contamination.

8.2 Sanitation and Housekeeping

8.2.1 The facility shall provide housekeeping services to maintain a clean, sanitary, safe environment which is free from odors.

8.2.2 Birth rooms shall be thoroughly cleaned after each use.

8.2.3 All cleaning materials, solutions, cleaning compounds and hazardous substances shall be:

8.2.3.1 Properly identified;

8.2.3.2 Stored in a safe place; and

8.2.3.3 Stored separate from care items and food.

8.2.4 Cleaning shall be performed in a manner which minimizes the spread of pathogenic organisms in the environment.

8.2.5 The facility shall be kept free of insects and rodents. A contract with a pest control agency shall be executed and available for review.

8.3 Waste Storage and Disposal

8.3.1 All rubbish and refuse containers shall be impervious, lined and clean.

8.3.2 All rubbish and refuse shall be collected, stored and disposed of in a manner designed to prevent transmission of disease.

8.3.3 All contaminated dressings, pathological or similar waste shall be properly disposed of.

8.3.4 All personnel must wash their hands immediately after handling rubbish or refuse.

8.4 Maintenance

8.4.1 The facility shall establish and implement a written program of preventive maintenance to ensure that all essential mechanical, electrical and patient care equipment is in safe operating condition.

8.4.2 Stairwells and corridors shall be kept free from obstruction at all times.

8.5 Safety

8.5.1 Fire safety:

8.5.1.1 The facility shall comply with the rules and regulations of the State Fire Prevention Commission.

8.5.1.2 The facility must be inspected annually by the fire marshal having jurisdiction and all applications for license (new and renewal) must include a letter certifying compliance by the fire marshal having jurisdiction.

8.5.1.3 Notification of non-compliance with the rules and regulations of the State Fire Prevention Commission shall be grounds for licensure action.

8.5.1.4 A simulated fire drill shall be performed every quarter on each work shift.

8.5.1.4.1 A written record of each fire drill shall be kept on file at the facility.

8.5.1.4.2 The written record must include the following:

8.5.1.4.2.1 Date and time of the drill;

8.5.1.4.2.2 Description of the simulated emergency fire condition;

8.5.1.4.2.3 Signatures and titles of those participating in the drill;

8.5.1.4.2.4 Duration of the drill; and,

8.5.1.4.2.5 Evaluation of the drill.

8.5.2 Facility safety:

8.5.2.1 The facility shall make provisions for the reporting and investigation of and corrective action for accidental events regarding patients, visitors and personnel.

8.5.2.2 Needles and syringes shall be disposed of appropriately.

8.5.2.3 Every bathroom door lock shall be designed to permit the opening of the locked door from the outside in an emergency.

8.5.2.4 Each birthing room shall have a nurse call system.

8.5.2.5 Each toilet and bathing area shall have grab bars and a nurse call system.

8.5.2.6 The temperature of the water supply to shower, bathing and handwashing facilities shall be automatically regulated not to exceed 110° Fahrenheit.

8.5.2.7 Emergency numbers shall be located near the telephone.

8.5.2.8 There shall be a written evacuation plan for the removal of patients in the event of an emergency.

8.5.2.8.1 The evacuation plan shall be posted in a conspicuous place on each floor of the building.

**History**
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *25 DE Reg. 777 (02/01/22)*
- *12 DE Reg. 235 (08/01/08)*
- *25 DE Reg. 777 (02/01/22)*

##### **16 Del. Admin. Code § 3365-9.0** Physical Plant {#sec-3365-9.0 omnilex-key=us-de-regs-official--title-16--3365-9.0}

9.1 Minimum construction requirements are set forth herein.

9.2 All construction, new/renovations/remodeling, must conform to the design and construction standards recognized by the Department.

9.3 In the event that there is a conflict between the design and construction standard utilized by the Department and the minimum standard set forth herein, the higher standard or requirement shall prevail.

9.4 When a facility is classified under this law or regulation and plans to construct, extensively remodel or convert any building, one (1) copy of properly prepared plans and specifications for the entire facility shall be presented to the Department.

9.4.1 An approval, in writing, shall be obtained from the Department before construction/renovation/remodeling work is begun.

9.4.2 Upon completion of construction/renovation/remodeling, in accordance with the plans and specifications, the Department will inspect and approve the site prior to occupancy/use by the facility.

9.5 All facilities shall either be at grade level or shall be equipped with ramps or elevators to allow easy access for persons with disabilities.

9.6 The facility shall comply with all local and state building codes and ordinances as pertain to this occupancy.

**History**
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *25 DE Reg. 777 (02/01/22)*
- *12 DE Reg. 235 (08/01/08)*
- *25 DE Reg. 777 (02/01/22)*

##### **16 Del. Admin. Code § 3365-10.0** Equipment and Supplies {#sec-3365-10.0 omnilex-key=us-de-regs-official--title-16--3365-10.0}

10.1 The facility shall be equipped with those items needed to provide low risk maternity care and shall include equipment to initiate emergency procedures in life-threatening events to mother and newborn.

10.2 Equipment shall include but not be limited to:

10.2.1 Furnishings suitable for labor, delivery and recovery;

10.2.2 Oxygen with flow meters and masks or equivalent;

10.2.3 Mechanical and bulb suction;

10.2.4 Resuscitation equipment for the mother and newborn;

10.2.5 Emergency medications, intravenous fluids and related supplies and equipment for both the mother and newborn;

10.2.6 Fetal monitoring equipment;

10.2.7 A means for monitoring and maintaining the optimum body temperature of the newborn;

10.2.8 An infant scale;

10.2.9 A clock with a sweep second hand;

10.2.10 Sterile suturing equipment and supplies; and

10.2.11 An adjustable examination light.

**History**
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *25 DE Reg. 777 (02/01/22)*
- *12 DE Reg. 235 (08/01/08)*
- *25 DE Reg. 777 (02/01/22)*

##### **16 Del. Admin. Code § 3365-11.0** Patient Rights {#sec-3365-11.0 omnilex-key=us-de-regs-official--title-16--3365-11.0}

11.1 The facility shall establish and implement policies and procedures regarding the rights of patients.

11.2 The facility must provide the patient with a written notice of the patient's rights during the initial assessment visit or before admission for services.

11.3 Each patient shall have the right to:

11.3.1 Be treated with courtesy, consideration, respect and dignity;

11.3.2 Self-determination and choice, including the opportunity to participate in developing one's plan for care;

11.3.3 Privacy and confidentiality;

11.3.4 Be protected from abuse, neglect, mistreatment, financial exploitation, solicitation and harassment;

11.3.5 Voice grievances without discrimination or reprisal;

11.3.6 Be fully informed, as evidenced by the patient's written acknowledgment of these rights, of all rules and regulations regarding patient conduct and responsibilities;

11.3.7 Be fully informed, at the time of admission, of services and activities available and related charges;

11.3.8 Be served by individuals who are properly trained and competent to perform their duties;

11.3.9 Refuse services and to be informed of possible negative consequences of her refusal;

11.3.10 To refuse to participate in experimental research;

11.3.11 Receive all the information needed to give informed consent for any proposed procedure or treatment. This information shall include the possible risks and benefits of the procedure or treatment; and,

11.3.12 Request transfer from the facility to another health care facility.

**History**
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *25 DE Reg. 777 (02/01/22)*
- *12 DE Reg. 235 (08/01/08)*
- *25 DE Reg. 777 (02/01/22)*

##### **16 Del. Admin. Code § 3365-12.0** Disaster Preparedness {#sec-3365-12.0 omnilex-key=us-de-regs-official--title-16--3365-12.0}

12.1 The facility shall have a current internal emergency plan(s) that provides for fires, bomb threats, severe weather, utility service failures and other disasters such as earthquakes, flooding, chemical spills and toxic fumes.

12.2 The disaster preparedness plan(s) must include provisions for relocation of persons within the building and/or partial or total evacuation.

12.3 All facility staff must be oriented to the disaster preparedness plan(s).

12.3.1 Records of staff attendance must be maintained in the employee file.

12.4 A copy of the disaster preparedness plan(s) shall be available to all staff.

**History**
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *25 DE Reg. 777 (02/01/22)*
- *12 DE Reg. 235 (08/01/08)*
- *25 DE Reg. 777 (02/01/22)*

##### **16 Del. Admin. Code § 3365-13.0** Quality Improvement {#sec-3365-13.0 omnilex-key=us-de-regs-official--title-16--3365-13.0}

13.1 Each facility shall develop and implement a documented ongoing quality improvement program. The program shall include at a minimum:

13.1.1 An internal monitoring process that tracks performance measures;

13.1.2 A review of the program's goals and objectives at least annually;

13.1.3 A review of the grievance/complaint process;

13.1.4 A review of all major adverse incidents;

13.1.5 A review of actions taken to address identified issues; and

13.1.6 A process to monitor the satisfaction of the patients with the services of the facility.

**History**
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *25 DE Reg. 777 (02/01/22)*
- *12 DE Reg. 235 (08/01/08)*
- *25 DE Reg. 777 (02/01/22)*

##### **16 Del. Admin. Code § 3365-14.0** Infection Prevention and Control Program {#sec-3365-14.0 omnilex-key=us-de-regs-official--title-16--3365-14.0}

14.1 The birthing center shall establish and implement an infection prevention and control program which shall be based upon Centers for Disease Control and Prevention and other nationally recognized infection prevention and control guidelines.

14.1.1 The infection prevention and control program must cover all services and each particular area of the birthing center, including provision of the appropriate personal protective equipment for all patients, staff and visitors.

14.2 The individual designated to lead the birthing center's infection prevention and control program must develop and implement a comprehensive plan that includes actions to prevent, identify, and manage infections and communicable diseases. The plan must include mechanisms that result in immediate action to take preventive or corrective measures that improve the birthing center's infection control outcomes.

14.3 All birthing center staff shall receive orientation at the time of employment and annual in-service education regarding the infection prevention and control program.

14.4 Specific Requirements for COVID-19

14.4.1 Before their start date, all new staff, vendors and volunteers must be tested for COVID-19 in accordance with Division of Public Health guidance.

14.4.2 All staff, vendors and volunteers must be tested for COVID-19 in a manner consistent with Division of Public Health guidance.

14.4.3 The birthing center must follow recommendations of the Centers for Disease Control and Prevention and the Division of Public Health regarding the provision of care or services to patients by staff, vendor or volunteer found to be positive for COVID-19 in an infectious stage.

14.5 The birthing center shall amend their policies and procedures to include:

14.5.1 Work exclusion and return to work protocols for staff tested positive for COVID-19;

14.5.2 Staff refusals to participate in COVID-19 testing;

14.5.3 Staff refusals to authorize release of testing results or vaccination status to the birthing center;

14.5.4 Procedures to obtain staff authorizations for release of laboratory test results to the birthing center to inform infection control and prevention strategies; and

14.5.5 Plans to address staffing shortages and the birthing center demands should a COVID-19 outbreak occur.

**History**
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *25 DE Reg. 777 (02/01/22)*
- *12 DE Reg. 235 (08/01/08)*
- *25 DE Reg. 777 (02/01/22)*

##### **16 Del. Admin. Code § 3365-15.0** Severability {#sec-3365-15.0 omnilex-key=us-de-regs-official--title-16--3365-15.0}

In the event any particular clause or section of these regulations should be declared invalid or unconstitutional by any court of competent jurisdiction, the remaining portions shall remain in full force and effect.

**History**
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *12 DE Reg. 235 (08/01/08)*
- *25 DE Reg. 777 (02/01/22)*
- *12 DE Reg. 235 (08/01/08)*
- *25 DE Reg. 777 (02/01/22)*

#### **3370** Hospital Standards (Construction, Maintenance, and Operation)

##### **16 Del. Admin. Code § 3370-1.0** General Licensing Requirements and Procedures {#sec-3370-1.0 omnilex-key=us-de-regs-official--title-16--3370-1.0}

1.1 Definitions: The definitions as contained in 16 Del.C. 1001 of the Hospital Licensure Law shall apply to these rules and regulations.

1.2 Purpose: The purpose of these regulations is to establish reasonable standards of equipment, capacity, sanitation, and any conditions which might influence the health care received by patients or promote the purposes of the Hospital Licensure Law.

1.3 Application: These rules and regulations apply to all health facilities that meet the criteria for a hospital as defined under 16 Del.C. 1001 of the Hospital Licensure Law. The Department of Health and Social Services in these regulations officially adopts certain National Standards for hospital licensure inspections and procedures. Nothing stated in these rules and regulations shall relieve a hospital from complying with local, city, county ordinances, codes, laws, regulations or relieve the hospital from compliance with other State or Federal requirements.

1.4 Issuance and Renewal of License. Upon receipt and approval of a complete application the Department of Health and Social Services shall issue or renew a license in accordance with one of the following categories:

1.4.1 Annual License: An annual license shall be issued or renewed on a calendar year basis if the applying hospital is in substantial compliance with the provisions of these rules and regulations:

1.4.2 Provisional License: A provisional license for a term not to exceed six (6) calendar months may be granted only to an applying hospital which, although not in substantial compliance, is demonstrating satisfactory evidence to meet the provisions of these rules and regulations.

**History**
- *18 DE Reg. 390 (11/01/14)*
- *18 DE Reg. 390 (11/01/14)*
- *25 DE Reg. 778 (02/01/22)*

##### **16 Del. Admin. Code § 3370-2.0** New Construction, Additions and Alterations {#sec-3370-2.0 omnilex-key=us-de-regs-official--title-16--3370-2.0}

2.1 Definition: "New construction, additions, and alterations" means new buildings to be used as hospitals, additions to existing buildings to be used as hospitals, conversion of existing buildings or portions thereof for use as hospitals, alterations other than minor alterations to existing hospitals.

2.2 A person desiring to establish a new hospital or a new addition or alteration to a licensed hospital must apply to the Department of Health and Social Services prior to establishing or beginning construction. The person must demonstrate that the new facility will meet the standards of these rules and regulations. A letter of approval to proceed with the development of plans and specifications will be issued by the Department of Health and Social Services to any person or hospital which demonstrates that the new facility will be in accordance with these rules and regulations. Plans and specifications for new construction, additions, or alterations, other than minor alterations must be prepared by or under the direction of an architect or engineer duly registered in the State of Delaware. A narrative description must be submitted with or prior to the submission of preliminary drawings. Final working drawings and specifications must be submitted to and approved by the Department of Health and Social Services prior to the beginning of actual construction.

2.3 Under the authority of 16 Del.C. Ch. 10 as amended, the Department of Health and Social Services adopts as the official standards for new construction, additions and alterations of hospitals, where applicable, the "Guidelines for Construction and Equipment of Hospital and Medical Facilities". U.S. Department of Health and Human Services, Public Health Service Publication Number (HRS-M-HF), 84-1 and all codes or standards referred under these adopted parts. When a hospital that is required to be licensed under these rules and regulations does not normally provide a particular service or department the parts of the following which relate to such service or department shall not be applicable. This Section of rules and regulations shall apply to new construction, additions, or alterations of hospitals only and not to existing facilities.

**History**
- *18 DE Reg. 390 (11/01/14)*
- *18 DE Reg. 390 (11/01/14)*
- *25 DE Reg. 778 (02/01/22)*

##### **16 Del. Admin. Code § 3370-3.0** Physical Environment {#sec-3370-3.0 omnilex-key=us-de-regs-official--title-16--3370-3.0}

3.1 Under the authority of 16 Del.C. Ch. 10, as amended, the Department of Health and Social Services adopts as the official standards for the physical environment in hospitals the following parts of the regulations, Medicare Program Regulations, 42 CFR Part 405, Subpart J, U.S. Department of Health and Human Services, Social Security Administration, dated October, 1977, Sections 405.1020 - 405.1034 inclusive, and all codes and standards referred to under these adopted parts. If any part of this section is in conflict with Section 50.1, "New Construction, Additions, and Alterations" this part shall be void and the preceding section shall apply. When a hospital that is required to be licensed under these rules and regulations does not normally provide a particular service or department, the parts of the following which relate to such service or department shall not be applicable.

3.2 Physical Environment. Section 405.1022 and subsection b of Section 405.1025 shall apply. The Department of Health and Social Services' regulation governing the sanitation of eating places shall also apply to the dietary department. The radiation control regulations adopted by the Authority on Radiation Protection shall govern the hospital's radiological department.

**History**
- *18 DE Reg. 390 (11/01/14)*
- *18 DE Reg. 390 (11/01/14)*
- *25 DE Reg. 778 (02/01/22)*

##### **16 Del. Admin. Code § 3370-4.0** Governing Body, Organization and Staff {#sec-3370-4.0 omnilex-key=us-de-regs-official--title-16--3370-4.0}

4.1 Under the authority of 16 Del.C. Ch. 10, as amended, the Department of Health and Social Services adopts as the official standards for the governing body, organization, and staff of hospitals the following parts of "Standards for Accreditation of Hospitals Plus Provisional Interpretations", published by the Joint Commission on Accreditation of Hospitals, dated 1981 Edition, and the "Requirements and Interpretative Guide for Accredited Hospitals", by the American Osteopathic Hospital Association, and all codes or standards referred to under these adopted parts. If any part of this section is in conflict with Section 2.0 "New Construction. Additions, and Alterations" or Section 3.0 "Physical Environment", this part shall be void and the preceding Sections shall apply. When a hospital that is required to be licensed under these rules and regulations does not normally provide a particular service or department the parts of the following which relate to such service or department shall not be applicable.

4.2 Allopathic Hospitals. Pages 1 through 107 inclusive of the Standards for Accreditation of Hospitals Plus Provisional Interpretations by the Joint Commission on Accreditation of Hospitals, shall apply to the governing body, organization and staff of all allopathic hospitals.

4.3 Osteopathic Hospitals. Pages 7 through 93 inclusive of the Requirements and Interpretative Guide for Accredited Hospitals by the American Osteopathic Association shall apply to the governing body, organization and staff of all osteopathic hospitals.

4.4 Hospitals must develop and implement policies and procedures for hospital staff to have ready access to a locked hospital bathroom in the event of an emergency.

**History**
- *18 DE Reg. 390 (11/01/14)*
- *18 DE Reg. 390 (11/01/14)*
- *25 DE Reg. 778 (02/01/22)*

##### **16 Del. Admin. Code § 3370-5.0** Fire Safety {#sec-3370-5.0 omnilex-key=us-de-regs-official--title-16--3370-5.0}

Fire safety in hospitals shall comply with the adopted rules and regulations of the State Fire Prevention Commission. Enforcement of the fire requirements is the responsibility of the State Fire Prevention Commission. All applications for license must include, with the application, a letter certifying compliance by the Fire Marshall having jurisdiction. Notification of non-compliance with the rules and regulations of the State Fire Prevention Commission may be grounds for revocation of license.

**History**
- *18 DE Reg. 390 (11/01/14)*
- *18 DE Reg. 390 (11/01/14)*
- *25 DE Reg. 778 (02/01/22)*

##### **16 Del. Admin. Code § 3370-6.0** Infection Prevention and Control Program {#sec-3370-6.0 omnilex-key=us-de-regs-official--title-16--3370-6.0}

6.1 The hospital shall establish and implement an infection prevention and control program which shall be based upon Centers for Disease Control and Prevention and other nationally recognized infection prevention and control guidelines.

6.1.1 The infection prevention and control program must cover all services and all areas of the hospital, including provision of the appropriate personal protective equipment for all patients, staff, and visitors.

6.2 The individual designated to lead the hospital's infection prevention and control program must develop and implement a comprehensive plan that includes actions to prevent, identify, and manage infections and communicable diseases. The plan must include mechanisms that result in immediate action to take preventive or corrective measures that improve the hospital's infection control outcomes.

6.3 All hospital staff shall receive orientation at the time of employment and annual in-service education regarding the infection prevention and control program.

6.4 Specific Requirements for COVID-19

6.4.1 Before their start date, all new staff, vendors and volunteers must be tested for COVID-19 in accordance with Division of Public Health guidance.

6.4.2 All staff, vendors and volunteers must be tested for COVID-19 in a manner consistent with Division of Public Health guidance.

6.4.3 The hospital must follow recommendations of the Centers for Disease Control and Prevention and the Division of Public Health regarding the provision of care or services to patients by staff, vendor or volunteer found to be positive for COVID-19 in an infectious stage.

6.5 The hospital shall amend their policies and procedures to include:

6.5.1 Work exclusion and return to work protocols for staff tested positive for COVID-19;

6.5.2 Staff refusals to participate in COVID-19 testing;

6.5.3 Staff refusals to authorize release of testing results or vaccination status to the hospital;

6.5.4 Procedures to obtain staff authorizations for release of laboratory test results to the hospital to inform infection control and prevention strategies; and

6.5.5 Plans to address staffing shortages and hospital demands should a COVID-19 outbreak occur.

**History**
- *18 DE Reg. 390 (11/01/14)*
- *18 DE Reg. 390 (11/01/14)*
- *25 DE Reg. 778 (02/01/22)*

#### **3375** Prescribed Pediatric Extended Care Centers (PPECC)

##### **16 Del. Admin. Code § 3375-1.0** Definitions {#sec-3375-1.0 omnilex-key=us-de-regs-official--title-16--3375-1.0}

“Advisory Board” means a group of health care professionals and at least one consumer approved by the PPECC Medical and Nursing Directors to review PPECC policies and procedures related to licensure and certification requirements, and to provide consultation regarding operational and programmatic components of the PPECC.

“American Academy of Pediatrics Red Book” means the Report of the Committee on Infectious Diseases published by the American Academy of Pediatrics to provide guidelines for the effective control of infectious diseases of children.

“Child Life Specialist” means an individual with baccalaureate preparation in Child Life, Early Childhood Education, or a related field and at least 2 years current experience in planning and implementing developmental stimulation programs for children.

“Current Experience” means full-time employment experience during the two years immediately preceding employment or contract with a PPECC facility.

“Delacare” means Requirements for Day Care Center, State of Delaware, Department of Services for Children, Youth and Their Families, as authorized by 31 Del.C. Ch. 3, Section 2.

“Developmentalist” means a master's prepared individual with 3 years current experience in multi-disciplinary evaluation and treatment planning for children who are at risk for or experiencing developmental delay.

“Functional Assessment” means an evaluation of the child's abilities and needs related to self care, communication skills, social skills, motor skills, preacademic areas, play with toys/objects, growth and development appropriate for age.

“Medical Director” means a Board-certified pediatrician licensed in Delaware who serves as the liaison between the PPECC and the medical community, reviews the quality and appropriateness of PPECC services, and is available for consultation to the PPECC staff.

“Nursing Director” means a licensed registered nurse, in the State of Delaware responsible for providing continuous supervision of PPECC services and managing the daily operations of the facility.

“Occupational Therapist” means a licensed individual in the State of Delaware who is registered with the American Occupational Therapy Association with at least 2 years current experience in evaluation and treatment planning for children with neuromuscular and developmental needs.

“Prescribed Pediatric Extended Care Center (PPECC)” means out-patient health care service prescribed by a physician for children who are medically and/or technologically dependent. As part of the continuum of care for medically dependent children, the PPECC includes an array of services focused on meeting the physiological as well as developmental, physical, nutritional and social needs of the children served. Children are placed in a PPECC facility because their medical condition requires continuous therapeutic interventions. The PPECC provides a less-restrictive alternative to institutionalization and reduces the isolation which the home-bound, medically dependent child may experience.

“Protocol of Care” means the comprehensive plan for implementation of medical, nursing, psychosocial, developmental, and educational therapies to be provided by the PPECC. An individualized Protocol of Care will be developed upon admission and will be revised to include recommended changes in the therapeutic plans. The disposition to be followed in the event of emergency situations will be specified in the Protocol of Care.

“Psychiatrist” means a Board-certified psychiatrist licensed in the State of Delaware with experience in child psychiatry.

“Psychologist” means a licensed individual in the State of Delaware with doctoral preparation in child or developmental counseling psychology, or a related field, and at least 2 years current experience in evaluation and management of children.

“Physical Therapist” means a licensed individual in the state of Delaware who is a graduate of an American Physical Therapy Association approved program with at least 2 years current experience in evaluating and designing therapeutic programs for children with developmental disabilities.

“Primary physician” means the physician who signs the order admitting the child to the PPECC and who maintains overall responsibility for the child's medical management and is available for consultation and collaboration with the PPECC staff.

“Quality Assurance” means a mandatory program which all PPECC facilities must have to assure periodic review and determination of the quality and appropriateness of care rendered in the facility.

“Social Worker” means an individual licensed in the State of Delaware who has a Master's degree in social work with at least 2 years current experience in assessing, counseling and planning interventions for children and their families or guardians.

“Speech Pathologist” means a licensed individual in the State of Delaware who is certified by the American Speech, Hearing and Language Association with at least 2 years current experience in evaluating and treating children at risk for, or experiencing problems with, communication skills.

“Technologically Dependent Child” means a person from birth through 21 years of age who has a chronic disability which requires the routine use of a specific medical device to compensate for the loss of a life-sustaining body function and requires daily, ongoing care or monitoring by trained personnel.

**History**
- *25 DE Reg. 779 (02/01/22)*
- *25 DE Reg. 779 (02/01/22)*

##### **16 Del. Admin. Code § 3375-2.0** Licensure Requirements {#sec-3375-2.0 omnilex-key=us-de-regs-official--title-16--3375-2.0}

2.1 Separate licenses are required for centers maintained in separate locations, even though operated under the same management.

2.2 License is not transferable from person to person nor from one location to another.

2.3 License will be conspicuously posted.

2.4 All applications for renewal of licenses shall be filed with the Department of Health and Social Services at least thirty (30) days prior to expiration.

2.4.1 Annual license. An annual license may be renewed yearly if the holder is in full compliance with this chapter and the rules and regulations of the Department of Health and Social Services.

2.4.2 Provisional license. A provisional license shall be granted for a term of 90 days only and shall be granted only to a facility which, although not in full compliance, is nevertheless demonstrating evidence of improvement.

2.4.3 Restricted license. A restricted license shall be granted for a term of 90 days when the facility is not in compliance with this chapter, and does not demonstrate evidence of improvement. The holder of a restricted license may not admit patients to the facility to which the restricted license applies during the period of restriction, but the facility may remain in operation until such license is revoked, expires, becomes annual or provisional.

2.4.4 Fees. The application fee is $100.00 and the annual license fee is $50.00

2.5 No rules will be adopted by the licensee which are in conflict with these regulations.

2.6 The Department of Health and Social Services will be notified, in writing, of any changes in the Medical Director or Nursing Director.

2.7 Authorized staff from the Department of Health and Social Services and the Department of Services for Children, Youth and Their Families shall have access to facility, staff, children receiving services and client records.

2.8 The Department of Health and Social Services may revoke, suspend, deny, restrict or make provisional a license for reasons which include, but are not limited to:

2.8.1 Failure to comply with the provisions of 16 Del.C. 122 (q) and the Department's rules and regulations pertaining to the law; or

2.8.2 Violation of the terms and conditions of a license; or

2.8.3 Use of fraud or misrepresentation in obtaining a license or in the subsequent operation of the facility; or

2.8.4 Refusal to furnish the Department with files, reports or records as required by the law; or

2.8.5 Refusal to permit an authorized representative of the Department to gain admission to the Center during operating hours; or

2.8.6 Any conduct or practice, engaged in or permitted, which adversely affects or presents a serious or imminent danger to the health, safety and wellbeing of any child attending the Center; or

2.8.7 Any conduct or practice which is in violation of State law related to abuse or neglect of children.

2.9 Appeals

2.9.1 Any person or Center who has been denied a license or whose license has been revoked, suspended or restricted shall be notified in writing of the reason(s) for such a decision and setting forth the person's or Center's right to an appeal of the decision.

2.9.2 Any person or Center who has been denied a license or whose license has been revoked, suspended or restricted by the Department of Health and Social Services, shall be entitled to a hearing and a review before the Department of Health and Social Services or its designee.

2.9.3 The Department of Health and Social Services shall give ten (10) days notice specifying reasons for proposed revocation, suspension, restriction or denial before a revocation, suspension, restriction or denial occurs. If a request for a hearing, either written or verbal, is received within the ten-day period, a hearing shall be held within 30 days.

2.9.4 The Department of Health and Social Services or its designee may change the status of a license to provisional without affording the licensee the benefit of a special hearing; however, the licensee shall be given an opportunity to address its licensure status at the next regularly scheduled meeting of the Department of Health and Social Services.

2.9.5 If the health or safety of children in care is in serious or imminent danger, as determined by the Department of Health and Social Services or its designee in its sole discretion, the Department of Health and Social Services or its designee may immediately suspend or restrict the license upon the issuance of written notice. If there is an immediate suspension or restriction, a hearing shall be held within ten (10) days of the written notice to the Center.

2.10 Upon written request by a Center, the Department of Health and Social Services or its designee may grant a variance from a specific requirement if there is documentation that the requested alternative complies with the intent of the requirement for which variance is sought.

2.10.1 The decision of the Department of Health and Social Services, including any qualification under which the variance is granted, shall be documented through a written agreement with the Department of Health and Social Services and a signed copy shall be sent to the Center. A variance may remain in effect for as long as a Center continues to comply with the intent of the requirement(s) or may be timelimited.

2.10.2 The agreement shall contain provisions for a regular review of the variance.

**History**
- *25 DE Reg. 779 (02/01/22)*
- *25 DE Reg. 779 (02/01/22)*

##### **16 Del. Admin. Code § 3375-3.0** Administration {#sec-3375-3.0 omnilex-key=us-de-regs-official--title-16--3375-3.0}

3.1 The administrative structure of the PPECC shall include a policy and procedure manual to assure that standards for licensure and certification are maintained.

3.2 All PPECCs must have the following documents on the premises and available to staff: American Academy of Pediatrics Red Book, Delacare Requirements for Day Care Centers, Approved Standards for Prescribed Pediatric Extended Care, Procedure Manual and a Personnel Manual.

3.3 Personnel policies and procedures shall include at least: a current personnel file; position descriptions; employee benefits; policies for overtime, compensatory time, performance evaluations, termination of employment; etc.

3.4 A formal orientation shall be required for all PPECC employees; staff development programs for all categories of personnel shall be held monthly and documented in the individual personnel file.

3.5 The facility shall be administered on a sound financial basis consistent with good business practice. There shall be financial records which identify all income by source and describe all expenditures by category in such a manner as to be auditable by commonly recognized procedures. Annual budget must be developed and available at the facility.

3.6 Each PPECC facility shall have an Advisory Board. Membership in the Advisory Board shall include, but not be limited to:

3.6.1 Physician familiar with PPECC services;

3.6.2 Registered nurse with special expertise in the care of medically/technologically dependent children;

3.6.3 Developmentalist or child life specialist with expertise in the care of medically/technologically dependent children and their families;

3.6.4 Social worker with expertise in the care of medically/technologically dependent children and their families;

3.6.5 Consumer representative who may be a parent or guardian of a child placed in the PPECC;

3.6.6 An independent or outside program professional.

3.7 Responsibilities of the Advisory Board shall include:

3.7.1 Review of policy and procedure components of the PPECC to assure conformance with the standards for licensure and certification;

3.7.2 Consultation regarding the operational and programmatic components of the PPECC.

3.8 Policies and Procedures pertaining to PPECC services shall be available and shall include the following.

3.8.1 A procedure manual with specifications for each therapeutic intervention shall be available for use by all staff involved in the care of the children; the manual shall be. reviewed every six months to assure that procedures conform to prevailing and acceptable treatment modalities.

3.8.2 An admission and discharge register, listing children admitted by name with identifying information about each and the source from which the child was admitted, the reason for disposition, adequate identifying information and the place to which the individual is to be discharged.

3.8.3 A daily census record.

3.8.4 An accident and incident record.

3.8.5 An individual record for each child. All details of the referral, admission, correspondence, and papers concerning each child shall also be maintained. A general fiscal record for each child, including copies of all agreements or contracts and account records. The record shall also include a protocol for care, physician's orders, progress notes, medications dispensed, medical history, including allergies, special precautions, and an immunization record. Record entries shall be in ink and signed by an RN or MD.

3.8.6 Periodic review of each child's protocol of care to update the protocol in consultation with other professionals involved in the child's care. Changes in the orders must be documented and signed by the primary prescribing physician.

3.8.7 Prior to a discharge, conferences involving PPECC staff, the primary physician, the parent(s) or guardians) and staff of other agencies involved in the child's care shall be held to discuss postdischarge care and follow-up.

3.8.8 A discharge order written by the primary physician shall be documented and entered in the child's record. A discharge summary, which includes the reason for discharge, shall also be included in the record.

3.8.9 Except in emergency situations, other agencies involved in the care of the child/family shall be notified prior to the discharge date.

3.9 The PPECC shall conform to the Patient Bill of Rights and a copy shall be posted in a conspicuous place.

**History**
- *25 DE Reg. 779 (02/01/22)*
- *25 DE Reg. 779 (02/01/22)*

##### **16 Del. Admin. Code § 3375-4.0** Children's/Parents' Rights {#sec-3375-4.0 omnilex-key=us-de-regs-official--title-16--3375-4.0}

4.1 Every child shall be treated with consideration, respect, and full recognition of his/her dignity and individuality.

4.2 Each child shall receive care, treatment and services which are adequate and appropriate for his/her therapeutic plan.

4.3 Parent(s) or legal guardian(s) shall, prior to or upon admission, and during the period of service to his/her child, receive a written statement of the services provided by the Center including those required to be offered on an "as needed" basis. They shall also receive a statement of related charges including any charges for services not covered under the facility's basic per diem rate.

4.4 Each child's medical care program shall be conducted discreetly and in accordance with the parent's/guardian's need for privacy. Personal and medical records shall be treated confidentially and shall not be made public without written consent of parent(s) or legal guardian(s).

4.5 Every child shall be free from mental and physical abuse and also chemical and physical restraints, unless authorized by a physician according to clear and indicated medical requirements.

4.6 Every parent or legal guardian has the right, personally or through others, to present grievances to local or state authorities without reprisal, interference, coercion or discrimination of the child as results of such grievance or suggestion.

**History**
- *25 DE Reg. 779 (02/01/22)*
- *25 DE Reg. 779 (02/01/22)*

##### **16 Del. Admin. Code § 3375-5.0** Requirements for Designation as PPECC {#sec-3375-5.0 omnilex-key=us-de-regs-official--title-16--3375-5.0}

5.1 All Prescribed Pediatric Extended Care Centers shall be equipped ad staffed to accommodate no fewer than six (6) medically/technologically dependent children and shall meet standards established herein and shall meet or exceed the licensure requirements and standards for child care as specified in "Delacare Requirements for Day Care Centers". When there is a contradiction between the standards, the PPECC standards shall prevail.

5.2 All PPECC Centers shall have a minimum full-time equivalent staff of two (2) registered nurses and one (1) nursing assistant. Thereafter the ratio of staff to children shall be maintained at a ratio of one (1) FTE staff for every three (3) children or one that meets the individual medical needs of the client.

**History**
- *25 DE Reg. 779 (02/01/22)*
- *25 DE Reg. 779 (02/01/22)*

##### **16 Del. Admin. Code § 3375-6.0** Criteria For Admission {#sec-3375-6.0 omnilex-key=us-de-regs-official--title-16--3375-6.0}

6.1 Infants and children considered for admission to the PPECC facility shall be those with complex medical conditions requiring continual care, including, but not limited to, ventilator dependence, seizure disorders, chronic lung disorder, supplemental oxygen, I.V. therapy, malignancy, tracheotomy, heart disease, etc.

6.2 The primary physician, in consultation with the parent(s) or legal guardian(s), shall recommend placement in PPECC facility, taking into consideration medical, emotional, psychosocial and environmental factors.

6.3 The child must not present significant risk of infection to other children or personnel.

6.4 The child must be medically stabilized, require skilled nursing care, and/or other interventions, and be appropriate for out-patient care.

6.5 If the child meets the preceding criteria, the primary physician or his/her designee shall contact the medical and/or nursing director of the PPECC to schedule a preadmission conference.

6.5.1 If the child is hospitalized at the time of referral pre-admission planning shall include relevant hospital, medical, nursing, social services and developmental staff in coordination with the nursing director of the PPECC to assure that the discharge plans shall be accommodated following placement in the PPECC.

6.5.2 If the child is not hospitalized at the time of the referral, pre-admission planning shall be conducted with the referring physician, medical director, parent(s) or guardian(s), and representatives of other relevant agencies as determined by the primary physician and nursing director of the PPECC.

6.5.3 Pre-admission planning must be, scheduled in a timely manner and allow sufficient time to assure that a written therapeutic plan shall be developed and implemented upon placement in the PPECC.

6.5.4 The protocol for care shall be developed by the PPECC staff following pre-admission planning.

6.5.5 The protocol for care shall include specifications of criteria for discharge from the PPECC.

6.5.6 A PPECC consent form, outlining the purpose of a PPECC facility, family responsibilities, authorized treatment and appropriate liability releases, and emergency disposition plans shall be signed by the parent(s) or guardian(s). Confidentiality of PPECC records shall be maintained in accordance with Standards of Medical Practice active in the State of Delaware.

**History**
- *25 DE Reg. 779 (02/01/22)*
- *25 DE Reg. 779 (02/01/22)*

##### **16 Del. Admin. Code § 3375-7.0** Admission Procedure {#sec-3375-7.0 omnilex-key=us-de-regs-official--title-16--3375-7.0}

7.1 Infants and children shall be considered for admission to the PPECC facility if they have complex medical conditions such as seizure disorders, chronic lung disorder, malignancy and heart disease and/or complex medical conditions requiring continual care including, but not limited to, ventilator dependence, supplemental oxygen, I.V. therapy, tracheotomy, etc.

7.2 All children placed in the PPECC facility shall have documentation of a physician's written order placed in the child's medical record. A copy of the order shall be provided to the child's parent(s) or guardian(s).

7.3 The protocol for care shall be developed under the direction of the PPECC nursing director and shall specify the treatment plan needed to accommodate the medical, nursing, psychosocial and educational needs of the child and family. Specific goals for care shall be identified. Plans for achieving the goals shall be determined and a schedule for evaluation of progress shall be established. The protocol shall include specific discharge criteria.

7.4 The protocol shall be signed by the physician, the authorized representative(s) of the PPECC and the parent(s) or guardian(s). Copies of the protocol shall be given to the parent(s) or guardian(s), primary physician, PPECC staff, and other agencies as appropriate.

**History**
- *25 DE Reg. 779 (02/01/22)*
- *25 DE Reg. 779 (02/01/22)*

##### **16 Del. Admin. Code § 3375-8.0** Services Available {#sec-3375-8.0 omnilex-key=us-de-regs-official--title-16--3375-8.0}

8.1 Medical Services

8.1.1 Children shall be admitted to the PPECC upon prescription by the child's primary physician or by the medical director.

8.1.2 The child's primary physician shall maintain responsibility for the overall medical therapeutic plan and shall be available for consultation and collaboration with the PPECC medical and nursing directors.

8.1.3 Communication with the child's primary physician shall be provided by the nursing director or designee on a monthly or quarterly basis.

8.1.4 Prescribed therapies shall be adjusted, in consultation with the primary physician, to accommodate the child's condition.

8.2 Nursing Services

8.2.1 The PPECC nursing director shall participate in pre-admission planning along with other appropriate nursing staff.

8.2.2 Nursing personnel, under the direction of the nursing director, shall be responsible for implementing the nursing care.

8.2.3 Nursing personnel shall be responsible for monitoring and documenting the effects of prescribed therapies.

8.2.4 Nursing personnel shall participate in interdisciplinary staff meetings regarding the child's progress.

8.2.5 Nursing personnel shall be responsible for maintaining the child's record in accordance with facility policies and procedures.

8.2.6 Nursing personnel shall instruct the parent(s) or guardian(s) in how to provide the necessary therapies in the home.

8.3 Developmental Services

8.3.1 Each child shall have a functional assessment and an individualized program plan to include developmentally appropriate areas.

8.3.2 The child's program plan shall include specific programs and action steps to facilitate developmental progress and shall be reviewed at least quarterly.

8.3.3 The child's developmental and educational needs shall be incorporated into protocol for care.

8.3.4 The child's program plan shall include:

8.3.4.1 Measurable goals in needs areas and/or goals to enhance and normalize independent functioning in daily activities and to promote socialization in order to minimize difficulties in being assimilated into the home/community environment;

8.3.4.2 A description of the child's strengths and present performance level with respect to each goal;

8.3.4.3 Skills areas in priority order;

8.3.4.4 Anticipatory planning for specific areas identified as at-risk for problems even though a specific delay or problem may not yet be demonstrable.

8.3.5 The developmentalist and/or child life specialist shall participate in regularly scheduled interdisciplinary staff meetings.

8.3.6 A program for parent(s) or guardian(s) shall be provided to prepare parent(s) or guardian(s) to accommodate the child's needs.

8.4 The PPECC shall assist parent(s) or guardian(s) by including them in care-related conferences and teaching them how to perform necessary therapies and how to meet the developmental and psychosocial needs of their child at home.

8.5 PPECC staff shall make referrals to appropriate resources, facilitate access to community, social, educational and financial services, and shall provide assistance to enhance coping skills, interpersonal relationships and family functioning.

8.6 Nutrition Services

8.6.1 A dietitian/nutritionist shall be available for consultation regarding the nutritional needs and special diets of individual children.

8.6.2 All food and formula shall be provided by PPECC staff under the supervision of the nursing director.

8.6.3 Prepared foods shall be kept under refrigeration with identifying dates and the child's name.

8.7 Infection Control

8.7.1 PPECC shall have written policies and procedures for infection control in accordance with the Delacare Requirements for Day Care, and the needs of all children being treated.

8.7.2 The PPECC shall establish and implement an infection prevention and control program which shall be based upon Centers for Disease Control and Prevention and other nationally recognized infection prevention and control guidelines.

8.7.2.1 The infection prevention and control program must cover all services and all areas of the PPECC, including provision of the appropriate personal protective equipment for all patients, staff and visitors.

8.7.3 The individual designated to lead the PPECC's infection prevention and control program must develop and implement a comprehensive plan that includes actions to prevent, identify, and manage infections and communicable diseases. The plan must include mechanisms that result in immediate action to take preventive or corrective measures that improve the PPECC's infection control outcomes.

8.7.4 All PPECC staff shall receive orientation at the time of employment and annual in-service education regarding the infection prevention and control program.

8.7.5 Specific Requirements for COVID-19

8.7.5.1 Before their start date, all new staff, vendors and volunteers must be tested for COVID-19 in accordance with Division of Public Health guidance.

8.7.5.2 All staff, vendors and volunteers must be tested for COVID-19 in a manner consistent with Division of Public Health guidance.

8.7.5.3 The PPECC must follow recommendations of the Centers for Disease Control and Prevention and the Division of Public Health regarding the provision of care or services to patients by staff, vendor or volunteer found to be positive for COVID-19 in an infectious stage.

8.7.6 The PPECC shall amend their policies and procedures to include:

8.7.6.1 Work exclusion and return to work protocols for staff tested positive for COVID-19;

8.7.6.2 Staff refusals to participate in COVID-19 testing;

8.7.6.3 Staff refusals to authorize release of testing results or vaccination status to the PPECC;

8.7.6.4 Procedures to obtain staff authorizations for release of laboratory test results to the PPECC to inform infection control and prevention strategies; and

8.7.6.5 Plans to address staffing shortages and the PPECC demands should a COVID-19 outbreak occur.

8.8 Transportation Services.

8.8.1 If transportation is provided by a PPECC and prescribed by the primary physician, a procedure delineating personnel and equipment to accompany the child shall be included in the PPECC procedure manual.

**History**
- *25 DE Reg. 779 (02/01/22)*
- *25 DE Reg. 779 (02/01/22)*

##### **16 Del. Admin. Code § 3375-9.0** Quality Assurance {#sec-3375-9.0 omnilex-key=us-de-regs-official--title-16--3375-9.0}

9.1 A Quality Assurance Committee shall be established and shall include a Board-certified pediatrician familiar with PPECC services, a registered nurse with special expertise in the care of medically/technologically dependent children, and one of the following: a developmentalist, child life specialist, or a social worker with expertise in the care of medically/technologically dependent children and their families.

9.2 All PPECCs shall have a quality assurance program and its QA Committee shall conduct quarterly reviews of the complete records for at least half of the children served by the PPECC at the time of the quality assurance review.

9.3 Each quarterly review shall include:

9.3.1 A review of the goals in each child's protocol;

9.3.2 A review of the steps, process, and success in achieving the goals;

9.3.3 Identification of goals not being achieved as expected, reasons for lack of achievement and plans to promote goal achievement;

9.3.4 Documentation of the results of the quality assurance review and records review.

9.3.5 Within fifteen (15) working days of its review, the Quality Assurance Committee shall furnish copies of its report to the PPECC medical and nursing directors.

9.3.6 Evidence that revisions have been made as recommended by the quality assurance report shall be forwarded to the Quality Assurance Committee within one week.

9.3.7 Implementation of the revisions to the protocol shall be documented on the child's record.

9.3.8 Maintenance of a high standard of patient care shall be evidenced by:

9.3.8.1 Case record for each child containing:

9.3.8.1.1 Comprehensive protocol for care specifying the goals for care and methods for goalachieving and time frame for reviewing and revising the plan;

9.3.8.1.2 A properly executed consent form;

9.3.8.1.3 A medical history for the child including notations from visits to health care providers and copy of a recent physical exam (updated annually);

9.3.8.1.4 Immunization record, documentation of allergies and special precautions;

9.3.8.1.5 Physician orders, properly signed;

9.3.8.1.6 Flow chart of treatment administered;

9.3.8.1.7 Concise, accurate information and initialed case.notes reflecting-progress toward protocol goal achievement or reasons for lack of progress;

9.3.8.1.8 Documentation of nutritional management and special diets, as appropriate;

9.3.8.1.9 Documentation of physical, occupational, speech and/or other special therapies.

9.3.8.2 Evidence of parent(s) or guardian(s) involvement including:

9.3.8.2.1 Pre-admission planning to develop a protocol for care to be rendered in the PPECC;

9.3.8.2.2 Interdisciplinary staffing conferences shall be scheduled on monthly or as necessary basis;

9.3.8.2.3 parent(s) or guardian(s) training and education, including:

9.3.8.2.3.1 Clearly written, practical and appropriately targeted training materials;

9.3.8.2.3.2 Scheduled individual and/or group education sessions for parent(s) or guardian (s) and other family members.

9.3.8.2.3.3 Evidence of formal discharge procedure, including:

9.3.8.2.3.3.1 Documentation that placement in the PPECC is no longer appropriate for the child;

9.3.8.2.3.3.2 Physician's discharge order;

9.3.8.2.3.3.3 Notification of anticipated discharge to the other agencies involved in the child's care;

9.3.8.2.3.3.4 Evidence of a pre-discharge conference involving the parent(s) or guardian(s), representatives of the PPECC professional staff and agencies involved in child care after discharge.

9.3.8.2.3.3.5 A written discharge summary signed by the primary physician and nursing director of the PPECC must be prepared within 1 week of the child's discharge.

9.3.8.2.4 Evidence of the disposition procedure to be followed in the event of an emergency medical situation.

**History**
- *25 DE Reg. 779 (02/01/22)*
- *25 DE Reg. 779 (02/01/22)*

##### **16 Del. Admin. Code § 3375-10.0** In-Service Training for Staff/Parent(s) and Guardian(s) {#sec-3375-10.0 omnilex-key=us-de-regs-official--title-16--3375-10.0}

10.1 Monthly staff development programs appropriate to the category of personnel shall be conducted to maintain quality patient care.

10.2 All staff development programs shall be documented.

10.3 All personnel shall be required to maintain certification in basic life support.

10.4 Each new employee shall participate in orientation to acquaint the employees with the philosophy, organization, program, practices, and goals of the PPECC facility.

10.5 A comprehensive orientation to acquaint the parent(s) and/or guardian(s) with the philosophy and services shall be provided at the time of child's placement in the PPECC.

10.6 Staff development programs shall be provided to:

10.6.1 Facilitate the ability of the staff to function as a member of an interdisciplinary team which includes health professionals and the parent(s) and/or guardian(s);

10.6.2 Improve communication skills to facilitate a collaborative relationship between parent (s) and/or guardians) and professionals;

10.6.3 Increase understanding the effects childhood illness has on the child's development and the parent(s) and/or guardian(s);

10.6.4 Increase understanding and coping with the effects of childhood illnesses and shall cover a variety of topics including: issues of death and dying; awareness of services available at the hospital, school, community, state, and professional organizations; and fostering of advocacy skills;

10.6.5 Develop case management skills to assist the family in setting priorities and planning and implementing the child's care at home;

10.6.6 Provide training in the implementation of new technology;

10.6.7 Develop a comprehensive Protocol for Care to include the medical, nutritional, developmental and psychosocial needs of medically/technologically dependent children;

10.6.8 Prepare for management of emergency medical situations in a PPECC setting.

**History**
- *25 DE Reg. 779 (02/01/22)*
- *25 DE Reg. 779 (02/01/22)*

##### **16 Del. Admin. Code § 3375-11.0** Medications {#sec-3375-11.0 omnilex-key=us-de-regs-official--title-16--3375-11.0}

11.1 All medications administered to children shall be ordered, in writing, by a physician.

11.2 All medications shall be stored in a locked cabinet, located in or convenient to the nurse's station/center.

11.3 Internal medications shall be stored separately from external medications.

11.4 Schedule II substances shall be kept in separately locked, securely fixed boxes or drawers in the locked medication cabinet; hence, under two (2) locks.

11.5 Medications requiring refrigeration shall be kept in a separate locked box within the refrigerator and separate from foods.

11.6 Barrel, plunger and needle of disposable hypodermic syringes must be rendered useless, immediately after use and then properly discarded.

11.7 Administrator/director shall notify the office of Narcotics and Dangerous Drugs, Division of Public Health, of any theft or unexplained loss of any controlled substances, syringes, or needles or prescription pads within 48 hours of discovery of such loss or theft.

11.8 Emergency Crash Cart equipped as per acceptable medical standards.

**History**
- *25 DE Reg. 779 (02/01/22)*
- *25 DE Reg. 779 (02/01/22)*

##### **16 Del. Admin. Code § 3375-12.0** Facility {#sec-3375-12.0 omnilex-key=us-de-regs-official--title-16--3375-12.0}

12.1 The PPECC shall conform with or exceed the minimum standards for physical facilities specified in Delacare Requirements For Day Care Centers. Where there is a contradiction between the PPECC standards and the child care standards, the PPECC standards shall prevail. All facilities licensed as PPECCs must be able to accommodate no fewer than six medically/technologically dependent children.

12.2 Specifications for a PPECC facility shall include:

12.2.1 Location shall be central to major thoroughfares and public transportation. Emergency transportation to hospital (with pediatric unit) can be achieved in ten minutes or less.

12.2.2 Entrance shall be barrier free, have a wheelchair ramp, provide for traffic flow with driveway area for entering and exiting, and have storage for supplies from home;

12.2.3 Adequate parking for staff and families to comply with applicable state laws.

12.3 The building specifications shall be in accordance with Delacare requirements.

12.4 All rooms and every part of the building shall be kept clean, orderly, and free of offensive odors.

**History**
- *25 DE Reg. 779 (02/01/22)*
- *25 DE Reg. 779 (02/01/22)*

##### **16 Del. Admin. Code § 3375-13.0** Equipment As per Delacare Requirements for Day Care Centers {#sec-3375-13.0 omnilex-key=us-de-regs-official--title-16--3375-13.0}

13.1 Fire Safety

13.1.1 Fire extinguishers and smoke detectors;

13.1.2 Emergency generator (portable).

13.2 Nursing Equipment and Supplies - There shall be sufficient equipment and supplies for nursing care to meet the needs of each patient. It shall be the responsibility of the administrator/ director to obtain specific items required for individual cases when so requested by the physician. The following items should be available as needed:

13.2.1 Nebulizers/Vaporizers - cool mist type - one at bedside of each child with a respiratory diagnosis as prescribed;

13.2.2 Mist tents - one per child with respiratory diagnosis as prescribed;

13.2.3 Mechanical percussors and hand percussors as prescribed;

13.2.4 Basic emergency equipment according to recommendations of the Medical Director, advisory board and primary physicians for individual children. Minimal emergency equipment to be available in a PPECC is listed in Emergency Equipment, Section K;

13.2.5 oxygen - in two portable tanks with appropriate tubing, pediatric ambu bag and masks for faces and tracheotomies;

13.2.6 Oxygen concentrators - for children on continuous 02 therapy;

13.2.7 Ventilator with provision for mixing of gases to provide prescribed oxygen concentration as specifically prescribed shall be available as a back-up unit when a ventilator-dependent child is in the facility;

13.2.8 Electronic thermometers - no glass thermometers;

13.2.9 Sphygmomanometers, stethoscopes, otoscopes;

13.2.10 Apnea monitoring supplies - i.e., belts, leads to apply to monitors from home;

13.2.11 Supplies of disposable equipment shall be on hand at the facility but not routinely provided if the family obtains supplies elsewhere. Disposable equipment/ supplies shall include suction catheters, gastrostomy tubes, nasogastric tubes, foley catheters, dressing supplies, syringes, needles.

13.2.12 All medical equipment will be safely stored when not in use.

**History**
- *25 DE Reg. 779 (02/01/22)*
- *25 DE Reg. 779 (02/01/22)*

##### **16 Del. Admin. Code § 3375-14.0** Severability {#sec-3375-14.0 omnilex-key=us-de-regs-official--title-16--3375-14.0}

Should any section, sentence, clause or phrase of these regulations be legally declared unconstitutional or invalid for any reasons, the remainder of said regulations -shall not be affected thereby.

**History**
- *25 DE Reg. 779 (02/01/22)*
- *25 DE Reg. 779 (02/01/22)*

#### **3380** Delivery of Hospice Services

##### **16 Del. Admin. Code § 3380-1.0** Definitions {#sec-3380-1.0 omnilex-key=us-de-regs-official--title-16--3380-1.0}

“A Coordinated Program” (including both services and personnel) implies the capacity to respond to patient/family needs whenever they arise. It also implies enough administrative and staff integration to ensure continuation of the same high quality care when the patient moves from home to inpatient care or vice versa.

“Bereavement” means that period of time, usually at least one year, during which survivors mourn the death and resolve their grief.

“Bereavement Service” means counseling and support services to be offered during the bereavement period.

“Family” means the hospice patient's kin. Other relations and individuals with significant personal ties to the hospice patient may be designated as members of the hospice patient's family.

“Governing Authority” means the policy-making body of a government agency, the Board of Directors or trustees of a not-for-profit corporation, or the proprietor or proprietors of an organization.

“Home Care Services” means services which are provided primarily in the patient's home. These services may include, but are not necessarily limited to, one or more of the following services: nursing services, physician services, home health aide services, homemaker services, physical therapy, social services, pastoral counseling and trained volunteer services.

“Hospice” means a coordinated program of home, outpatient and inpatient care under the direction of an identifiable hospice administration providing palliative and supportive medical and other health services to terminally ill patients and their families. Hospice is an option for care which utilizes a medically directed interdisciplinary team, which may also include services provided by trained volunteers. A hospice program provides care to meet the physical, psychological, social, spiritual and other special needs which are experienced during the final stages of illness, and during dying and bereavement. Hospice care shall be available twenty-four hours a day, seven days a week.

“Identifiable Hospice Administration” means an administrative group, individual or legal entity. This administration shall be responsible for the management of all aspects of the program.

“Inpatient Services” means those services to patients/families who require either 24 hour supervision in a health care facility; i.e., acute care hospital, skilled or intermediate care facility or services which necessitate the admission of the patient for treatment in the health care facility.

“Institution” as it appears in these regulations is used to refer to acute care hospitals, skilled nursing care facilities and intermediate care facilities (Title 16, Delaware Code).

“Interdisciplinary Care Team” means a care group of qualified individuals consisting of at least a physician, registered nurse, and social worker who collectively have expertise in assessing the special needs of hospice patients/families and in providing palliative and supportive care to meet the special needs arising out of the physical, psychological, spiritual, social and economic stress which are experienced during the final stages of illness, dying, and bereavement.

“Optional Mode of Care” means the patient volunteers to become a hospice patient after meeting certain eligibility criteria and signs a consent agreement to participate in the program.

“Outpatient Services” means those services which are delivered in other than the home setting or as an inpatient in a hospital facility. They are delivered on an ambulatory basis either in a physician's office, clinic setting, emergency room or other area such as an x-ray department.

“Palliative Services” means those services, and/or treatments which produce the greatest degree of relief from the symptoms caused by disease for the longest period of time, minimizing side effects. The goal of hospice care is to provide symptom control through appropriate palliative therapies.

“Patient/family Unit” means the patient and family are considered as one, and are the primary unit of care.

“Symptom Control” means the relief of distressing physical, emotional, social and spiritual symptoms of both patient and family. It does not mean "cure of disease".

“Terminally Ill Patient” means an individual in the terminal stage of illness, with an anticipated life expectancy of six months or less, who, alone or in conjunction with a family member, or members, has voluntarily requested admission and been accepted into a hospice.

“Trained Volunteers” means individuals who are required to participate in a structured orientation and training program before they become participants in the hospice program.

**History**
- *9 DE Reg. 415 (09/01/05)*
- *9 DE Reg. 415 (09/01/05)*
- *18 DE Reg. 135 (08/01/14)*
- *25 DE Reg. 781 (02/01/22)*
- *25 DE Reg. 781 (02/01/22)*
- *25 DE Reg. 781 (02/01/22)*
- *25 DE Reg. 781 (02/01/22)*
- *9 DE Reg. 415 (09/01/05)*
- *18 DE Reg. 135 (08/01/14)*
- *25 DE Reg. 781 (02/01/22)*

##### **16 Del. Admin. Code § 3380-2.0** Licensing Requirements {#sec-3380-2.0 omnilex-key=us-de-regs-official--title-16--3380-2.0}

2.1 The term hospice (or any like term such as hospice care, palliative care, etc.) shall not be used as a part of the name of any institution or description of services in the State unless it has been so classified by the Department of Health and Social Services.

2.2 Skilled care regulations, Intermediate care regulations, Hospital regulations shall apply when hospice inpatient care is to be provided.

2.3 All organizations whether or not they are currently licensed in the State of Delaware and/or are eligible to receive Medicare/Medicaid certification are required to apply for a hospice license if they plan to call themselves a hospice or to offer services described by them in terms such as hospice type care, palliative care, etc.

2.4 A license is not transferable from person to person nor from one location to another.

2.5 The license shall be conspicuously posted. All applications for renewal of licenses shall be filed with the Department of Health and Social Services at least thirty (30) days prior to expiration. Licenses will be issued for a period not to exceed one (1) year (twelve months), and may be issued for that period only if the hospice is in full compliance with these regulations. (Application fee is $100.00 and annual licensure fee is $50.00).

2.6 In addition to the annual license noted in 2.5 above provisional licensure may be granted by the Department of Health and Social Services for a period not exceeding three (3) months, when the hospice is in compliance with most but not all of these regulations and has demonstrated the ability and willingness to comply within the three (3) month period.

**History**
- *9 DE Reg. 415 (09/01/05)*
- *9 DE Reg. 415 (09/01/05)*
- *18 DE Reg. 135 (08/01/14)*
- *25 DE Reg. 781 (02/01/22)*
- *25 DE Reg. 781 (02/01/22)*
- *25 DE Reg. 781 (02/01/22)*
- *25 DE Reg. 781 (02/01/22)*
- *9 DE Reg. 415 (09/01/05)*
- *18 DE Reg. 135 (08/01/14)*
- *25 DE Reg. 781 (02/01/22)*

##### **16 Del. Admin. Code § 3380-3.0** Hospice Care {#sec-3380-3.0 omnilex-key=us-de-regs-official--title-16--3380-3.0}

3.1 Hospice is an option for care which utilizes an interdisciplinary team of the patient's choice. The team shall consist of at least a physician, nurse, social worker, trained volunteer, and the patient/family.

3.2 The interdisciplinary team shall have the following qualifications:

3.2.1 Licensed physician shall mean a physician who is licensed in the State of Delaware according to 24 Del.C. Ch. 17, Subchapter III.

3.2.2 Licensed nurse shall mean a registered nurse who is licensed in the State of Delaware according to 24 Del.C. §§1909-1912.

3.2.3 A social worker shall mean a person who is licensed in the State of Delaware according to 24 Del.C. Ch. 39.

3.2.4 A volunteer will be qualified to participate in the hospice program after completion of a structured orientation and training program.

3.2.5 Specialized services as deemed necessary by the interdisciplinary team shall be performed by persons qualified to perform such functions and licensed by the Delaware Code, if required.

3.2.6 Providers of special services such as homemaker/ home health aides, physical therapists, nutritional, pharmaceutical, psychiatric, psychological, radiological, pediatric, oncologic specialists or other therapists may also be included on the team as deemed necessary by the team.

3.2.7 One qualified health care professional member of the team shall be designated as the patient care coordinator.

3.3 The interdisciplinary team shall have the following responsibilities:

3.3.1 Perform an admission history which includes medical, social, spiritual, emotional aspects of the patient/family.

3.3.2 Develop the care plan for each patient/family. The patient care coordinator will be responsible for assuring the implementation and ongoing review of the care plan.

3.3.3 Hold an interdisciplinary care team meeting at least semimonthly or more often if needed to review and update the care plan.

3.3.4 Emphasize prevention and control of pain and other distressing symptoms.

3.3.5 Make provision for 24 hours per day, seven days a week coverage.

**History**
- *9 DE Reg. 415 (09/01/05)*
- *9 DE Reg. 415 (09/01/05)*
- *18 DE Reg. 135 (08/01/14)*
- *25 DE Reg. 781 (02/01/22)*
- *25 DE Reg. 781 (02/01/22)*
- *25 DE Reg. 781 (02/01/22)*
- *25 DE Reg. 781 (02/01/22)*
- *9 DE Reg. 415 (09/01/05)*
- *18 DE Reg. 135 (08/01/14)*
- *25 DE Reg. 781 (02/01/22)*

##### **16 Del. Admin. Code § 3380-4.0** Personnel/Administrative {#sec-3380-4.0 omnilex-key=us-de-regs-official--title-16--3380-4.0}

4.1 No rules shall be adopted by the licensee or administrator of the hospice program which are in conflict with these regulations.

4.2 The Department of Health and Social Services shall be notified, in writing, of any changes in the hospice administration.

4.3 Hospice program shall comply with applicable local, state and federal laws and regulations governing the organization and delivery of health care to patients and families.

4.4 The hospice administration shall adopt by-laws identifying the purpose of hospice and the means of fulfilling them.

4.5 A hospice administrator will be identified and be responsible for the overall coordination and administration of the hospice program.

4.6 A governing authority must be established. Hospice established within existing licensed hospitals, nursing homes and home health agencies need not establish a separate governing authority specifically for hospice but must provide a hospice advisory committee.

4.7 Governing authority shall:

4.7.1 Adopt by-laws which identify the purposes of hospice and the means of fulfilling them.

4.7.2 The governing authority shall establish a procedure for and regularly conduct a systematic professional and administrative review and program evaluation of the services. Licensed hospitals, nursing homes and home health agencies may establish a committee specifically for this purpose or they may assign the responsibility to an existing committee.

4.7.3 Governing authority shall prepare an annual review and program evaluation which should include, but not be limited to the following, and should be available upon request to the licensing agency:

**History**
- *9 DE Reg. 415 (09/01/05)*
- *9 DE Reg. 415 (09/01/05)*
- *18 DE Reg. 135 (08/01/14)*
- *25 DE Reg. 781 (02/01/22)*
- *25 DE Reg. 781 (02/01/22)*
- *25 DE Reg. 781 (02/01/22)*
- *25 DE Reg. 781 (02/01/22)*
- *9 DE Reg. 415 (09/01/05)*
- *18 DE Reg. 135 (08/01/14)*
- *25 DE Reg. 781 (02/01/22)*

##### **16 Del. Admin. Code § 3380-5.0** Patient Care Policies {#sec-3380-5.0 omnilex-key=us-de-regs-official--title-16--3380-5.0}

5.1 Every hospice shall develop written policies pertaining to the services they provide. Such policies shall include:

5.1.1 The goal of hospice care.

5.1.2 The scope of program services.

5.1.3 Interdisciplinary team services.

5.1.4 Bereavement services.

5.1.5 Home care services.

5.1.6 Inpatient services.

5.1.7 Palliative services.

5.1.8 A written policy denoting care of patients:

5.1.8.1 In an emergency.

5.1.8.2 During a communicable disease episode.

5.1.9 Criteria for discharge from hospice programs.

5.2 The policies should reflect the philosophy and objectives of the hospice program.

5.3 Admission to a hospice is limited to the following:

5.3.1 Patient in the terminal state of illness whose survival is anticipated to be less than six months.

5.3.2 Patients who are no longer receiving treatment for cure.

5.3.3 The patient and physician agree that palliative care is appropriate.

5.3.4 The patient or the patient's legal guardian choose hospice care.

5.3.5 A hospice program shall not admit any persons under the age of eighteen (18) years without a signed parent/guardian consent.

5.3.6 Each hospice program must have a policy and procedures regarding informed consent agreement.

5.3.7 At the time of admission to the hospice and thereafter, a patient/family must be under the care of a physician who shall be responsible for medical care.

5.3.8 Admission is limited to those patients who have a family member, or designated person who is able and willing to assume the role of primary care giver.

5.4 The patient/family is the unit of care.

5.5 The hospice program must establish written policies regarding the rights and responsibilities of patients and these policies and procedures are to be made available to patient/family or patient/guardian. The rights of patients shall be consistent with Titles 16 and 31 of the Delaware Code and the Department of Health and Social Services Regulations regarding Patient's Rights.

5.6 The program shall exhibit with the admission agreement to all patients or their sponsors a complete statement enumerating all charges for services, materials and equipment which shall, or may be, furnished to the patient during the period of participation in the program.

5.7 The hospice program shall present to the patient, in writing, the prepayment and refund policies at the time of admission, and in the case of third party payment, an exact statement of responsibility in the event of retroactive denial. The patient shall be notified in writing of any changes in third party coverage prior to the implementation of such changes.

**History**
- *9 DE Reg. 415 (09/01/05)*
- *9 DE Reg. 415 (09/01/05)*
- *18 DE Reg. 135 (08/01/14)*
- *25 DE Reg. 781 (02/01/22)*
- *25 DE Reg. 781 (02/01/22)*
- *25 DE Reg. 781 (02/01/22)*
- *25 DE Reg. 781 (02/01/22)*
- *9 DE Reg. 415 (09/01/05)*
- *18 DE Reg. 135 (08/01/14)*
- *25 DE Reg. 781 (02/01/22)*

##### **16 Del. Admin. Code § 3380-6.0** Service to Patients {#sec-3380-6.0 omnilex-key=us-de-regs-official--title-16--3380-6.0}

6.1 General services:

6.1.1 The hospice organization shall be considered the responsible provider of the services and shall be ultimately responsible for the quality of services rendered.

6.1.2 A hospice contracting for components of its program shall require as part of the contract, that the contractor comply with the provisions of the hospice regulation regarding a coordinated program of home and inpatient care services.

6.1.3 The hospice organization shall develop, implement and revise, as necessary, written policies and procedures for the operation of a coordinated program of home and inpatient services to cover at least the following:

6.1.3.1 Delineation of responsibility for delivering and for maintaining coordinate care.

6.1.3.2 Direct provision of services provided by the hospice organization.

6.1.3.3 Mechanisms for assuring quality hospice care when segments of care are provided by contracting parties.

6.1.3.4 Statement of how coordination of services is to be assured.

6.1.3.5 Home care services shall be provided by an organization which has received Medicare/Medicaid certification.

6.1.3.6 Inpatient care shall be provided in a licensed facility which is primarily engaged in providing to inpatients those services defined in Title 16 of the Delaware Code pertaining to Acute Care Hospitals, Intermediate Care Facilities and Skilled Care Facilities.

6.1.3.7 Bereavement services shall be available to the family for at least one year following the death of the patient.

6.2 Medical services:

6.2.1 All persons admitted to a hospice shall be under the care of a licensed physician.

6.2.2 All hospice programs shall arrange for one (1) or more licensed physicians to be called in an emergency. Names and phone numbers should be posted.

6.2.3 Patient/physician encounters shall be at a frequency not less than that described in the written plan of care or as otherwise required to meet demonstrated patient/family needs.

6.2.4 Medical services to be provided in an inpatient setting shall be consistent with those regulations established in Title 16 of the Delaware Code pertaining to Acute Care Hospitals, ICF and SNF.

6.2.5 Transfer Agreements shall be negotiated between the hospice organization and inpatient facilities to insure a smooth transition should the need for such services develop.

6.3 Specialized services:

6.3.1 All specialized services shall be ordered, in writing, by the interdisciplinary care team physician, such as physical therapy, occupational therapy, speech therapy, etc.

6.3.2 An interdisciplinary care team member will notify the patient/family, as soon as possible, when a special service has been ordered.

6.4 Nursing services:

6.4.1 Nursing services provided within an inpatient facility will be consistent with the regulations contained within Title 16 of the Delaware Code pertaining to Acute Care Hospitals, ICF and SNF.

6.4.2 Hospice nursing services shall be available directly, via written agreement seven days a week, 24 hours per day under the supervision of a director of nurses who is licensed in the State of Delaware.

6.4.3 Written policies and procedures for nursing services shall be developed and implemented by the hospice to incorporate objectives and maintain the standards of nursing practice as well as coordinate, integrate and provide continuity of patient/family care in conjunction with other services during illness and after discharge/death to assure physician orders are followed.

6.5 Medications:

6.5.1 All medications administered to patients shall be ordered in writing and signed by the patient's physician or the interdisciplinary care physician.

6.5.2 Existing regulations for medications administered to patients in inpatient facilities will be applicable to hospice patients in inpatient facilities.

6.5.3 Medication administered to hospice patients should be consistent with the hospice philosophy which focuses on palliation; i.e., controlling pain and relieving other symptoms which are manifested during the dying process.

6.5.4 Resource materials relating to the administration and untoward effects of medications and treatments used in pain and symptom control will be readily available to nursing personnel.

6.5.5 The hospice must develop and implement written policies and procedures to include the requirements of the Department of Health and Social Services’ Protocol Regarding the Safe Disposal of Unused Prescription Medication Following the Death of an In-Home Hospice Patient (refer to Appendix A).

6.6 Inpatient services:

6.6.1 Develop and implement written policies and procedures for inpatient services which provide for facilities and services which create a home-like atmosphere and reflect hospice philosophy insofar as possible under physical and utilization constraints. These policies may include, but should not be limited to, the following:

6.7 Inservice training and continuing education shall be offered on a regular basis. Documentation of this training and continuing education will be maintained and available on request to the licensing authority.

6.8 Records:

6.8.1 The hospice organization shall maintain a complete record for each patient/family which contains all information pertaining to supportive management of the patient/family and which is maintained in conformance with generally accepted medical record practices. Records necessary to record the daily treatment of the patient should be maintained at the site of treatment.

6.8.2 Each patient/family record shall be retained by the hospice organization for a five-year period after death or discharge from the hospice. In the case of a minor, records shall be kept for a five year period after death. If the minor is discharged from the hospice, records shall be kept for a five year period after the minor attains majority.

6.8.3 The patient care plan will give direction to the care given in meeting the physiological, psychological, sociological and spiritual needs of patient/family. The plan will identify those care givers who will be participating in this plan. The plan will specifically address maintenance of patient independence and control.

6.8.4 The plan will be recorded in ink and maintained as part of the patient/family record.

6.8.5 All services ordered and rendered shall be entered in the patient/family record.

6.8.6 Written documentation of all interdisciplinary care team meetings is necessary.

6.8.7 The plan of care must be prepared within three days of the patient's admission to the home care component of the hospice program and within two days of admission to the inpatient component of the hospice program.

6.8.8 All required records maintained by the hospice organization shall be open to inspection by the authorized representatives of the Department of Health and Social Services.

**History**
- *9 DE Reg. 415 (09/01/05)*
- *9 DE Reg. 415 (09/01/05)*
- *18 DE Reg. 135 (08/01/14)*
- *25 DE Reg. 781 (02/01/22)*
- *25 DE Reg. 781 (02/01/22)*
- *25 DE Reg. 781 (02/01/22)*
- *25 DE Reg. 781 (02/01/22)*
- *9 DE Reg. 415 (09/01/05)*
- *18 DE Reg. 135 (08/01/14)*
- *25 DE Reg. 781 (02/01/22)*

##### **16 Del. Admin. Code § 3380-7.0** Infection Prevention and Control Program {#sec-3380-7.0 omnilex-key=us-de-regs-official--title-16--3380-7.0}

7.1 The hospice program shall establish and implement an infection prevention and control program which shall be based upon Centers for Disease Control and Prevention and other nationally recognized infection prevention and control guidelines.

7.1.1 The infection prevention and control program must cover all services and all areas of the hospice program, including provision of the appropriate personal protective equipment for all patients, staff and visitors.

7.2 The individual designated to lead the hospice program's infection prevention and control program must develop and implement a comprehensive plan that includes actions to prevent, identify, and manage infections and communicable diseases. The plan must include mechanisms that result in immediate action to take preventive or corrective measures that improve the hospice program's infection control outcomes.

7.3 All hospice program staff shall receive orientation at the time of employment and annual in-service education regarding the infection prevention and control program.

7.4 Specific Requirements for COVID-19

7.4.1 Before their start date, all new staff, vendors and volunteers must be tested for COVID-19 in accordance with Division of Public Health guidance.

7.4.2 All staff, vendors and volunteers must be tested for COVID-19 in a manner consistent with Division of Public Health guidance.

7.4.3 The hospice program must follow recommendations of the Centers for Disease Control and Prevention and the Division of Public Health regarding the provision of care or services to patients by staff, vendor or volunteer found to be positive for COVID-19 in an infectious stage.

7.5 The hospice program shall amend their policies and procedures to include:

7.5.1 Work exclusion and return to work protocols for staff tested positive for COVID-19;

7.5.2 Staff refusals to participate in COVID-19 testing;

7.5.3 Staff refusals to authorize release of testing results or vaccination status to the hospice program;

7.5.4 Procedures to obtain staff authorizations for release of laboratory test results to the hospice program to inform infection control and prevention strategies; and

7.5.5 Plans to address staffing shortages and hospice program demands should a COVID-19 outbreak occur.

**History**
- *9 DE Reg. 415 (09/01/05)*
- *9 DE Reg. 415 (09/01/05)*
- *18 DE Reg. 135 (08/01/14)*
- *25 DE Reg. 781 (02/01/22)*
- *25 DE Reg. 781 (02/01/22)*
- *25 DE Reg. 781 (02/01/22)*
- *25 DE Reg. 781 (02/01/22)*
- *9 DE Reg. 415 (09/01/05)*
- *18 DE Reg. 135 (08/01/14)*
- *25 DE Reg. 781 (02/01/22)*

##### **16 Del. Admin. Code § 3380-8.0** Suspension or Revocation of Licenses {#sec-3380-8.0 omnilex-key=us-de-regs-official--title-16--3380-8.0}

8.1 The Department of Health and Social Services may suspend or revoke a license issued pursuant to these regulations on any of the following grounds:

8.1.1 Violation of these rules and regulations issued pursuant thereto.

8.1.2 Permitting, aiding or abetting the commission of any illegal act in the hospice operation.

8.1.3 Conduct or practices detrimental to the health or welfare of the patient.

8.2 Before any license issued pursuant to these regulations is suspended or revoked, thirty (30) days notice shall be given in writing to the holder of the license, during which time he may appeal for a hearing before the Department of Health and Social Services. The Department of Health and Social Services shall hear the appeal at the next regularly scheduled meeting of the Department of Health and Social Services and shall render its decision within fifteen (15) days following such hearing.

**History**
- *9 DE Reg. 415 (09/01/05)*
- *9 DE Reg. 415 (09/01/05)*
- *18 DE Reg. 135 (08/01/14)*
- *25 DE Reg. 781 (02/01/22)*
- *25 DE Reg. 781 (02/01/22)*
- *25 DE Reg. 781 (02/01/22)*
- *25 DE Reg. 781 (02/01/22)*
- *9 DE Reg. 415 (09/01/05)*
- *18 DE Reg. 135 (08/01/14)*
- *25 DE Reg. 781 (02/01/22)*

##### **16 Del. Admin. Code § 3380-9.0** Renewal of License After Suspension or Revocation {#sec-3380-9.0 omnilex-key=us-de-regs-official--title-16--3380-9.0}

If and when the conditions upon which the suspension or revocation of a license are based have been corrected, a new license may be granted.

**History**
- *9 DE Reg. 415 (09/01/05)*
- *9 DE Reg. 415 (09/01/05)*
- *18 DE Reg. 135 (08/01/14)*
- *25 DE Reg. 781 (02/01/22)*
- *25 DE Reg. 781 (02/01/22)*
- *25 DE Reg. 781 (02/01/22)*
- *25 DE Reg. 781 (02/01/22)*
- *9 DE Reg. 415 (09/01/05)*
- *18 DE Reg. 135 (08/01/14)*
- *25 DE Reg. 781 (02/01/22)*

##### **16 Del. Admin. Code § 3380-10.0** Severability {#sec-3380-10.0 omnilex-key=us-de-regs-official--title-16--3380-10.0}

Should any section, sentence, clause or phrase of these regulations be legally declared unconstitutional or invalid for any reason, the remainder of said regulations shall not be affected thereby.

Protocol Regarding the Safe Disposal of Unused Prescription Medication Following the Death of an In-Home Hospice Patient

The Department of Health and Social Services expects that each in-home hospice agency’s policies and procedures will address each of the following:

A. Medication Disposal Following the Death of an In-Home Hospice Patient

1. Designation of hospice staff that will assist in the disposal of all unused prescription medications, regardless of the prescriber.

2. Definition of the timeframe in which the designated staff must:

a. Assist in the disposal of the unused prescription medications following the death on an in-home hospice patient; or

b. Contact the family member/designated primary care giver to arrange an appointment to assist in the disposal of the unused prescription medications if the in-home hospice patient was transferred to an inpatient hospice unit prior to the death; or

c. Dispose of the unused prescription medication in the presence of another designated hospice staff in the event that the in-home hospice patient does not have a family member or designated primary care giver.

3. Checking of the medication label to confirm that the medication belonged to the patient, prior to assisting in the disposal of the unused prescription medication.

4. Disposal of the unused prescription medications by at least one family member/designated primary care giver with the assistance of the designated hospice staff.

5. Disposal of the medications in accordance with the United States Food and Drug Administration guidelines which can be found at http://www.fda.gov.

6. Prohibition of removal by designated hospice staff of the unused prescription medications from the patient’s residence.

7. Actions the designated hospice staff must take upon evidence of missing unused prescription medication(s).

8. Diversion/retention of the deceased patient’s unused prescription medications could result in criminal offenses.

B. Education

1. Education of the family member/designated primary caregiver upon the in-home hospice patient’s admission and death, as follows:

a. Provision of a copy of the written hospice policies and procedures on the disposal of all prescription medications following the death of an in-home hospice patient.

b. Discussion of the prescription medication disposal policy in a language and manner that they understand to ensure that these parties are educated regarding the following:

i. the hospice’s policies and procedures for the safe disposal of all prescription medications following the death of an in-home hospice patient; and

ii. the diversion/retention of the deceased patient’s unused prescription medications could result in criminal offenses.

2. Education of hospice staff regarding the hospice’s prescription medication disposal policy at the following times:

a. prior to implementation of the policies and procedures;

b. prior to any policy and procedure revision; and

c. upon hire (if applicable).

C. Patient Record Documentation

1. Storage of patient records readily retrievable for 5 years after the patient’s death.

2. Inclusion of the following in the patient’s record:

a. Documentation that the hospice’s policies and procedures regarding the safe disposal of all unused prescription medications were provided and discussed with the family member/designated primary care giver upon the patient’s admission and in-home death.

b. Documentation of one of the following:

i. an inventory of all disposed prescription medications and the signature of the family member/designated primary care giver that witnessed the disposal; or

ii. family member/designated primary care giver refusal to dispose of prescription medications.

D. Personnel Education Documentation

1. Education regarding the hospice’s prescription medication disposal policy must be documented at the following times:

a. prior to implementation of the policies and procedures;

b. prior to any policy and procedure revision; and

c. upon hire (if applicable).

**History**
- *9 DE Reg. 415 (09/01/05)*
- *9 DE Reg. 415 (09/01/05)*
- *18 DE Reg. 135 (08/01/14)*
- *25 DE Reg. 781 (02/01/22)*
- *25 DE Reg. 781 (02/01/22)*
- *25 DE Reg. 781 (02/01/22)*
- *25 DE Reg. 781 (02/01/22)*
- *9 DE Reg. 415 (09/01/05)*
- *18 DE Reg. 135 (08/01/14)*
- *25 DE Reg. 781 (02/01/22)*

### **4000** Division of Public Health

#### **4100** Family Health Services

#### **4101** Birth Defect Surveillance and Registry Program

##### **16 Del. Admin. Code § 4101-1.0** Purpose {#sec-4101-1.0 omnilex-key=us-de-regs-official--title-16--4101-1.0}

1.1 Birth defects are one of the causes of infant mortality and disabilities in Delaware. A Birth Defects Surveillance System, or Birth Defects Registry, will enable the Department of Health and Social Services (DHSS), Division of Public Health (DPH) to collect birth defects data, to create a statewide registry, and to link surveillance with tracking of individual children for the provision of services.

1.2 The purpose of the Birth Defects Registry is to provide information to Public Health officials as to the existence of previously unrecognized health and environmental hazards, help prevent certain birth defects and ultimately decrease the infant mortality rate. The Birth Defects Registry will gather data to assist with identification of risk factors, including environmental and hereditary, assist in the investigation of causes and prevalence; assist in the development of strategies to reduce the occurrence of, or prevent such defects; and track and follow-up abnormal newborn hearing screening results.

1.3 The usefulness of the data collected in the Birth Defects Registry will depend upon the full and accurate reporting of such defects by health care practitioners, health care facilities, clinics and laboratories.

1.4 The Birth Defects Registry will be a component of the Newborn Screening Case Management System, including metabolic and hearing screening. All results of metabolic and hearing screens will become part of the screening record. Tracking and follow-up of incomplete and abnormal cases will be followed by the Division of Public Health Newborn Screening Program.

##### **16 Del. Admin. Code § 4101-2.0** Definitions {#sec-4101-2.0 omnilex-key=us-de-regs-official--title-16--4101-2.0}

The following words shall have the meanings indicated:

"Birth Defect" means any structural or biochemical abnormality, regardless of cause, diagnosed at any time before or after birth, that requires medical or surgical intervention or that interferes with normal growth or development. This includes abnormal newborn hearing screening. Reportable birth defects are listed in Appendix A of these Regulations.

"Division" refers to the Division of Public Health under the Department of Health and Social Services.

"Registry" means a central data bank containing collected, classified, coded, and sorted data relating to defects in children under age 5, reported by health care providers.

"Surveillance" means the process of identifying and investigating birth defects in children under age 5.

##### **16 Del. Admin. Code § 4101-3.0** Reporting Requirements {#sec-4101-3.0 omnilex-key=us-de-regs-official--title-16--4101-3.0}

The provisions of this section shall apply to the Delaware Health and Social Services, Division of Public Health, Birth Defect Registry:

3.1 The registry shall collect information on any birth defect diagnosed in utero and postpartum on anyone who is a resident of the state of Delaware, or whose parent is a resident of Delaware, and who is diagnosed at any time prior to age five (5) as having a birth defect. For the purposes related to the registry the Division shall have access to any medical record of the child that pertains to a diagnosed or suspected birth defect. Prenatal information on the birth mother may be obtained with prior consent.

3.2 Any diagnosed birth defects shall be reported for all infants and children up to age 5, including those who have since died (if the data is still available).

3.3 For purposes of these reporting requirements, reportable diagnoses are those diagnoses, from the International Classification of Diseases (ICD), as listed in Appendix A of these regulations. The reportable diagnoses listed in Appendix A may be revised, upon notice, to reflect changes in publications accepted for use by the Centers for Disease Control and Prevention or State.

3.4 The following persons and organizations are required to report occurrences of birth defects within 30 days of diagnosis to the Division of Public Health.

3.4.1 Any physician, surgeon, dentist, podiatrist, certified nurse midwife, or other health care practitioner who diagnoses or provides treatment, or both, for a child under age 5 with birth defects who is not known to be previously reported;

3.4.2 The designated representative of any clinical laboratory that performs any test which identifies a child or children under age 5 with birth defects not known to be previously reported; and

3.4.3 The designated representative of any hospital, dispensary, clinic, or other similar public or private institution that diagnoses or provides treatment, or both, for a child or children under age 5 with birth defects who is not known to be previously reported.

3.4.4 This section of the regulations shall not apply to any person or private institution that, as an exercise of religious freedom, treats the sick or suffering by spiritual means through prayer alone.

3.5 The administrative officer of every health care facility shall be responsible for establishing reporting procedures at that facility, using the identified Birth Defect Registry reporting form. Reporting procedures must ensure that each infant initially diagnosed as having a birth defect shall be reported to the Division. Any presumptive or actual diagnosis in a child up to the age of 5 must be reported to the Division.

3.6 Reporting sources shall complete the Division of Public Health Birth Defects Surveillance Form for each reported case, and forward the completed form to the Division of Public Health Director or designee.

3.7 Reporting sources are required to submit annual follow-up information as requested through Birth Defect Program.

##### **16 Del. Admin. Code § 4101-4.0** Confidentiality of Reports {#sec-4101-4.0 omnilex-key=us-de-regs-official--title-16--4101-4.0}

4.1 No report of a diagnosis or treatment of a birth defect shall be disclosed in such a way as to identify the child who is the subject of the report, or as to identify the child's family. However, patient-identifying information may be exchanged among authorized agencies as approved by the Department and upon receipt by the Department of satisfactory assurances by those agencies of the preservation of the confidentiality of such information. Agencies will maintain the confidentiality of any information exchanged for the purpose of delivery of program services, evaluation, early intervention and epidemiological investigation.

4.2 Any parent, custodian or guardian of any infant having any birth defect may refuse disclosure to the surveillance system and registry of the infant’s name and identifying information on the grounds that such birth defect identification is contrary to the religious tenets and practices of the infant’s parent, custodian or guardian.

4.3 No individual or organization providing information pursuant to these regulations shall be held liable for divulging such information to the Division.

##### **16 Del. Admin. Code § 4101-5.0** Penalties {#sec-4101-5.0 omnilex-key=us-de-regs-official--title-16--4101-5.0}

Any person or organization required to report the diagnosis or treatment of a birth defect pursuant to these regulations, and who violates these regulations, shall be subject to a fine of up to $100 for each violation, pursuant to 16 Del.C. Sec. 206. Justices of the Peace Courts have jurisdiction over such violations.

##### **16 Del. Admin. Code § 4101-6.0** Severability {#sec-4101-6.0 omnilex-key=us-de-regs-official--title-16--4101-6.0}

In the event any particular clause or section of the regulations should be declared invalid or unconstitutional by any court of competent jurisdiction, the remaining portions shall remain in full force and effective.

Broad Categories

Specific Categories

ICD-9 Codes

Congenital Infections

Congenital syphilis

090.0 - 090.3

Congenital rubella

771.0

Congenital cytomegalovirus

771.1

Congenital toxoplasmosis (not specific code)

771.2

Other infections specific to perinatal period

771.80

Other congenital infections

771.x

Neoplasms

Neurofibromatosis

237.70

Endocrine, Nutritional, Metabolic, Immunological Diseases

Congenital hypothyroidism

243.00

Phenylketonuria

270.10

Galactosemia

271.1

Cystic Fibrosis

277.00.01

Other Metabolic diseases

Diseases of Blood

Sickle Cell Disease

282.60

Other hemoglobinopathies

282.63, 282.69, 282.4

Developmental Disorders

Developmental Language Disorder

315.31-315.39

Coordination Disorder

315.40

Mental Retardation

317 - 319

Congenital Anomalies of Central Nervous System

Anencephalus

740.0 -740.1

Spina bifida without anencephalus

741.0,741.9 w/o

740.0-740.10

Hydrocephalus without spina bifida

742.3 w/o

741.0, 741.9

Encephalocele

742.0

Microcephalus

742.1

Holoprosencephaly/Porencephaly

742.2

Other Congenital Anomalies of Nervous System

742.4 - 742.9

Congenital Anomalies of the Eye

Anophthalmia/microphthalmia

743.0,743.1

Congenital cataract

743.30 -743.34

Aniridia

743.45

Glaucoma

743.20 -743.22

Coloboma

743.46*

Congenital Anomalies of the Ear

Anotia/microtia

744.01,744.23

Congenital Anomalies of the Cardiovascular System

Common truncus

745.0

Transposition of great arteries

745.10,745.11, 745.12, 745.19

Tetralogy of Fallot

745.2

Ventricular septal defect

745.4

Atrial Septal Defect

745.5

Endocardial cushion defect

745.60,745.61, 745.69

Single Ventricle

745.3

Pulmonary valve atresia and stenosis

746.01,746.02

Tricuspid valve atresia and stenosis

746.1

Ebstein’s anomaly

746.2

Aortic valve stenosis

746.3

Hypoplastic left heart syndrome

746.7

Patent ductus arteriosus >2500 gms

747.0

Coarctation of aorta

747.10

Pulmonary artery anomalies

747.3

Congenital anomalies of the Respiratory System

Anomalies of larynx/trachea/bronchus

748.30

Lung agenesis/hypoplasia

748.5

Other respiratory anomalies

Congenital Anomalies of the Orofacial Area

Cleft palate without cleft lip

749.00 -749.04

Cleft lip with or without cleft palate

749.1,749.2

Choanal atresia

748.0

Congenital Anomalies of the Gastrointestinal Tract

Esophageal atresia/tracheoesophageal fistula

750.3

Atresia/stenosis of intestine and rectum

751.10,751.2

Hirschsprung’s disease (congenital megacolon)

751.3

Anomalies of internal fixation of bowel

751.40

Biliary atresia

751.61

Malrotation of intestine

751.4*

Pyloric stenosis

750.5

Anorectal malformation

751.4*

Congenital Anomalies of the Genitourinary System

Renal Agenesis/hypoplasia

753.0

Bladder exstrophy

753.5

Cloacal exstrophy

*

Cystic/dysplastic kidneys

753.10,753.15

Obstructive genitourinary defect

753.2,753.6

Hypospadias and Epispadias

752.6

Ambiguous genitalia

752.9*

Polycystic kidneys

753.12 -753.14

Congenital Anomalies of the Musculoskeletal Regions

Reduction defect, upper limbs

755.20 -755.29

Polydactyly/

Syndactyly/

Adactyly

755.00 -755.02

755.10 -755.14

755.4*

Reduction defect, lower limbs

755.30-755.39

Arthrogryposis multiplex congenital

754.89*

Achondroplasia

756.4

Osteogenesis imperfecta

756.51

Other skeletal dysplasia Gastroschisis

756.7

Omphalocele

756.7

Diaphragmatic hernia (moved up)

756.6

Scoliosis/Lordosis/Kyphosis

754.0, 756.19

Congenital hip dysplasia

754.30, 754.31

754.35*

Club Foot

754.50, 51, 53, 60, 70, 79

Craniosynostosis

756.0*

Chromosomal Disorders

Trisomy 21 (Down syndrome)

758.0

Trisomy 13

758.1

Trisomy 18

758.2

Autosomal deletion syndromes

758.30

Other conditions due to autosomal anomalies

758.50

Gonadal dysgenesis (Turner’s syndrome)

758.60

Klinefelter’s syndrome

758.70

Other conditions due to sex chromosome anomalies

758.80

Conditions due to anomaly of unspecified Chromosome

758.90

Fragile X Syndrome

759.83

Other Congenital Malformations

Amniotic bank disruption complex

no code

Embryopathy from Toxic Exposure in Utero

Fetal Alcohol syndrome

760.71

Phenytoin

760.79*

Isotretinoin

760.79*

Warfarin

760.79*

Other toxic exposures

760.7x

Conductive hearing loss, external ear

389.01

Conductive hearing loss, middle ear

389.03

Ear disorder, unspecified

388.9

Hearing loss, noise-induced

388.12

Hearing loss, sudden, unspecified

388.2

Hearing loss, unspecified

388.9

Sensorineural hearing loss, unspecified

389.10

#### **4103** Inherited Metabolic Disorders

##### **16 Del. Admin. Code § 4103** Inherited Metabolic Disorders {#sec-4103 omnilex-key=us-de-regs-official--title-16--4103}

Delaware Code 201 provides for the assistance with the cost of treatment of children with birth defects. Inherited Metabolic Disorders are one such birth defect for which a fund has been established to assist with the cost of treatment.

**History**
- *3 DE Reg. 529 (10/1/99)*

##### **16 Del. Admin. Code § 4103-1.0** Purpose {#sec-4103-1.0 omnilex-key=us-de-regs-official--title-16--4103-1.0}

Inherited metabolic disorders, if undetected and untreated, can result in severe mental retardation, and possibly death, in infancy. Universal screening and milk product substitution is now a standard of medical care. If a child diagnosed with an inherited metabolic disorder amenable to dietary treatment is not able to maintain a strict dietary regime throughout life the individual will likely be developmentally delayed.

The Specialty Formula Fund (“Fund”) provides that certain expenses for specialty formula, in the on-going treatment of inherited metabolic disorders, may be covered through the Department of Health and Social Services, Division of Public Health, Specialty Formula Fund.

The purpose of the Fund is to assist families in meeting the high cost of special or metabolic formulas, required to treat inherited metabolic disorders. The Division of Public Health will work to coordinate services and reduce obstacles families encounter regarding information and resource referral.

Supporting individuals with special health care needs can place economic constraints on families. The cost of special formula may be prohibitive for some families. In situations where special formula has been prescribed by a physician, and not covered by insurance, there is justification to provide economic assistance under the Fund.

**History**
- *3 DE Reg. 529 (10/1/99)*

##### **16 Del. Admin. Code § 4103-2.0** Definitions {#sec-4103-2.0 omnilex-key=us-de-regs-official--title-16--4103-2.0}

“Case Review Panel” means a group composed of individuals with knowledge of inherited metabolic disorders, whose purpose is to review each newly diagnosed case involving the special formula fund.

"Inherited Metabolic Disorder,” means a disorder caused by an inherited abnormality of body chemistry, which includes those disorders screened for by the state's Newborn Screening Program located within the Division of Public Health.

"Speciality Formula" means a milk product substitution that is intended for the therapeutic dietary treatment of inherited metabolic disorders for which nutritional requirements are established by medical evaluation.

“Speciality Formula Fund” means funds provided to the Division of Public Health by the General Assembly, for prescribed specialty formula for women of child bearing age and children with inherited metabolic disorders.

**History**
- *3 DE Reg. 529 (10/1/99)*

##### **16 Del. Admin. Code § 4103-3.0** Eligibility {#sec-4103-3.0 omnilex-key=us-de-regs-official--title-16--4103-3.0}

3.1 Any Delaware woman of child bearing age or child diagnosed with an Inherited Metabolic Disorder, that warrants the prescription of a specialty formula may be eligible to receive assistance through the Specialty Formula Fund if uninsured or if current insurance benefit does not include this coverage. The assistance will be based on the current Department of Health and Social Services Ability to Pay Fee Schedule (see attached), less the average cost of formula for a normal newborn/infant or citizen using soy based milk products annually. The Fee Schedule is adjusted annually with the revised federal poverty guidelines.

3.2 The Division of Public Health may provide assistance from the Fund to a woman of child bearing age or child diagnosed with an Inherited Metabolic Disorder, if:

3.2.1 The specialty formula is prescribed as medically necessary for the therapeutic treatment of an Inherited Metabolic Disorder; and

3.2.2 The specialty formula is administered under the direction of a physician; and

3.2.3 The client’s insurer does not provide benefits to cover prescribed formula for inherited metabolic disorder or there are special circumstances as determined by the Division of Public Health, Case Review Panel.

**History**
- *3 DE Reg. 529 (10/1/99)*

##### **16 Del. Admin. Code § 4103-4.0** Application {#sec-4103-4.0 omnilex-key=us-de-regs-official--title-16--4103-4.0}

The Division of Public Health will:

4.1 Staff the Case Review Panel; and

4.2 Review and refer non-compliant woman of child bearing age, parents/guardians of children with an inherited metabolic disorder to appropriate agencies for follow-up; and

4.3 Determine, on a case by case basis, any assistance to be provided to a woman of child bearing age or child from this fund.

**History**
- *3 DE Reg. 529 (10/1/99)*

##### **16 Del. Admin. Code § 4103-5.0** Roles/Responsibilities {#sec-4103-5.0 omnilex-key=us-de-regs-official--title-16--4103-5.0}

5.1 The Division of Public Health will appoint a Case Review Panel to make recommendations to assist the Division of Public Health in determining the assistance provided to a woman of child bearing age or child from this fund. This group will also act as a case management team for women of child bearing age, children and their families, if necessary, with public and private providers of health care and/or insurance providers. The members may have a background in metabolic disease. The panel may include a Geneticist, Nutritionist, Newborn Screening Program staff member, a Physician who treats metabolic disorders, and one or more community member(s). The Genetics Director will chair the Case Review Panel and the Division of Public Health will provide staff.

The Case Review Panel will meet on a regular basis to review cases and make recommendations to the Division of Public Health. All current cases will be reviewed within the first six months of initiation of the Case Review Panel. The Case Review Panel will convene, as needed, to review newly diagnosed cases.

**History**
- *3 DE Reg. 529 (10/1/99)*

##### **16 Del. Admin. Code § 4103-6.0** Authorization for Payment {#sec-4103-6.0 omnilex-key=us-de-regs-official--title-16--4103-6.0}

6.1 The Division of Public Health may authorize assistance prior to the review of the Case Review Panel in cases of immediate need based on physician prescription.

6.2 The Division of Public Health may provide assistance based on the physician’s prescription, recommendation of the Case Review Panel, the calculation of the quantity of formula needed, economic need, and the availability of appropriated funds.

6.3 Assistance under this fund is limited to the appropriation of the General Assembly for this purpose.

6.4 The Division of Public Health will reevaluate each case every year or if health benefit coverage changes.

6.5 Women of child bearing age or the parent or guardian of a child receiving assistance from the Fund are obligated to contact the Division of Public Health, immediately, if any changes in status or eligibility occur.

**History**
- *3 DE Reg. 529 (10/1/99)*

##### **16 Del. Admin. Code § 4103-7.0** Referrals {#sec-4103-7.0 omnilex-key=us-de-regs-official--title-16--4103-7.0}

7.1 The Division of Public Health will accept referrals from specialty hospitals, institutions, other state agencies, primary care physicians, other health care professionals, self referrals, or referrals from the family.

7.2 Referrals should include the following information: client’s name, parent or guardian’s name, address, phone number, social security number of client, diagnosis, formula prescription type and amount per month, feeding schedule, client’s age, financial information, and any pertinent medical data.

**History**
- *3 DE Reg. 529 (10/1/99)*

#### **4106** Practice of Non‑Nurse Midwifery (Repealed)

##### **16 Del. Admin. Code § 4106** Practice of Non‑Nurse Midwifery (Repealed) {#sec-4106 omnilex-key=us-de-regs-official--title-16--4106}

This regulation was repealed, effective December 11, 2024.

**History**
- *5 DE Reg. 1918 (04/01/02)*
- *28 DE Reg. 455 (12/01/24)*

#### **4109** Autism Surveillance and Registration Program

##### **16 Del. Admin. Code § 4109-1.0** Purpose {#sec-4109-1.0 omnilex-key=us-de-regs-official--title-16--4109-1.0}

1.1 Autism is a severe neurodevelopmental disorder whose prevalence appears to be increasing in Delaware and across the United States. An Autism Surveillance and Registration, or an Autism Registry, will enable the Department of Health & Social Services (DHSS), Division of Public Health (DPH) to collect basic descriptive information on the individuals with autism, to track changes in prevalence over time, to inform the planning of service delivery to children with autism and their families, and to facilitate autism research.

1.2 The purpose of the Autism Registry is to provide an accurate and continuing source of data concerning autism to provide information to Public Health officials to help to ultimately decrease the autism morbidity burden associated with the disorder. The Autism Registry will gather data to assist with: prevalence estimation, cluster investigation, risk factor identification, and outcome assessment.

1.3 The usefulness of the data collected in the Autism Registry will depend upon the full and accurate reporting of the confirmed diagnosis of autism by health care practitioners, hospitals, and clinical laboratories.

1.4 The Autism Registry will be a separate component of the Newborn Screening Management System.

**History**
- *8 DE Reg. 1481 (4/1/05)*

##### **16 Del. Admin. Code § 4109-2.0** Definitions {#sec-4109-2.0 omnilex-key=us-de-regs-official--title-16--4109-2.0}

The following words shall have the meanings indicated:

"Autism" means any structural or biochemical abnormality, regardless of cause, diagnosed at any time before or after birth, that requires medical or surgical intervention or that interferes with normal growth or development. Reportable autism diagnoses are listed in Appendix A of these Regulations.

“Confirmed Autism or Diagnosed Autism” means an abnormality characterized by each of the following symptoms:

Impaired social behavior:

marked impairment in the use of multiple nonverbal behaviors, such as eye-to-eye gaze, facial expression, body postures, and gestures to regulate social interaction

failure to develop peer relationships appropriate to developmental level

a lack of spontaneous seeking to share enjoyment, interest, or achievements with other people (e.g., by a lack of showing, bringing, or pointing out objects of interest)

lack of social or emotional reciprocity

Abnormal development of communication skills:

delay in, or total lack of, the development of spoken language (not accompanied by an attempt to compensate through alternative modes of communication such as gesture or mime)

in individuals with adequate speech, marked impairment in the ability to initiate or sustain a conversation with others

stereotyped and repetitive use of language or idiosyncratic language

lack of varied, spontaneous make-believe play or social imitative play appropriate to developmental level

Lack of awareness of the need for emotional support and little emotional response to family members:

encompassing preoccupation with one or more stereotyped and restricted patterns of interest that is abnormal either in intensity or focus

apparently inflexible adherence to specific, nonfunctional routines or rituals

stereotyped and repetitive motor mannerisms (e.g., hand or finger flapping or twisting or complex whole-body movements)

persistent preoccupation with parts of objects

"Division" refers to the Division of Public Health under the Department of Health and Social Services.

“Infant” refers to a newborn from birth to 1 year of age.

“Registry" means a central data bank containing collected, classified, coded, and sorted data relating to confirmed autism in children from birth through age 17, as reported by health care practitioners, hospitals and clinical laboratories.

"Surveillance" means the process of identifying and investigating confirmed autism in children under age 18.

“Suspected Autism” is a term used for an infant or young child who is showing some developmental variations that do not meet the criteria for autism but whose variations have been shown to be associated with a risk of eventually developing all of the traits of autism.

**History**
- *8 DE Reg. 1481 (4/1/05)*

##### **16 Del. Admin. Code § 4109-3.0** Reporting Requirements {#sec-4109-3.0 omnilex-key=us-de-regs-official--title-16--4109-3.0}

The provisions of this section shall apply to the Delaware Health and Social Services, Division of Public Health, Autism Registry:

3.1 The registry shall collect information on any child under the age eighteen (18) who is a resident of the state of Delaware, or whose parent is a resident of Delaware, and who is diagnosed at any time prior to age eighteen (18) as having confirmed autism. For the purposes related to the registry the Department shall have access to any medical record of the child with confirmed autism.

3.2 The Department shall have access to information in the medical records of children with suspected autism. On request of the Department all mandated reporting sources should identify children who have suspected autism. The Department shall have access to records of such children.

3.3 Any diagnosis of confirmed autism shall be reported for all infants and children up to age 18, including those who have since died (if the data is still available).

3.4 For purposes of these reporting requirements, reportable diagnoses are those diagnoses, from the International Classification of Diseases (ICD) and DSM IV as listed in Appendix A of these regulations; as well as the 6-digit modified Pediatric Association system (BPA/ICD-9). The reportable diagnoses listed in Appendix A may be revised, upon notice, to reflect changes in publications accepted for use by the Centers for Disease Control and Prevention.

3.5 The following persons and organizations are required to report occurrences of autism within 30 days of diagnosis to the Division of Public Health.

3.5.1 Any physician, surgeon, dentist, podiatrist, or other health care practitioner who diagnoses a child with autism under age 18 who is not known to be previously reported. Other health care practitioners will include but not be limited to: psychiatrists, clinical and school psychologists, speech and language pathologists, licensed clinical social workers, and nurses including school nurses;

3.5.2 The designated representative of any clinical laboratory conducting assessment, evaluation or research that performs any test which identifies a child or children under age 18 with confirmed autism not known to be previously reported; and

3.5.3 The designated representative of any hospital that diagnoses a child or children under age 18 with confirmed autism.

3.6 The administrative officer of every health care facility shall be responsible for establishing reporting procedures at that facility, using the identified Autism Registry Reporting Form. Reporting procedures must ensure that, on the effective date of these regulations, each child up to the age of 18 diagnosed as having confirmed autism or currently under care with a diagnosis of confirmed autism must be reported to the Division.

3.7 Reporting sources shall complete the Division of Public Health Autism Surveillance Form for each reported case, and forward the completed form to the Division of Public Health Director or designee within 30 days of the diagnosis.

**History**
- *8 DE Reg. 1481 (4/1/05)*

##### **16 Del. Admin. Code § 4109-4.0** Follow-up Information from Reporting Sources {#sec-4109-4.0 omnilex-key=us-de-regs-official--title-16--4109-4.0}

Any follow-up information, including family, physician, hospital or clinical laboratory contact deemed necessary by the Department, shall be submitted to the Department at least 1 time each year by those required to report occurrences of autism. The required follow-up information for the Autism Surveillance and Registry system will be sent to the same address as the Autism Registry Report Form.

**History**
- *8 DE Reg. 1481 (4/1/05)*

##### **16 Del. Admin. Code § 4109-5.0** Exemption Based on Religious Grounds {#sec-4109-5.0 omnilex-key=us-de-regs-official--title-16--4109-5.0}

5.1 The provisions of these regulations shall not apply to any person or private institution that, as an exercise of religious freedom, treats the sick or suffering by spiritual means through prayer alone.

5.2 A parent, custodian or guardian of an infant having uatism may refuse disclosure to surveillance system and registry of the infant’s name and identifying information on the grounds that such autism identificatin is contrary to the religious tents and practices of the infant’s parent, custodian or guardian.]

**History**
- *8 DE Reg. 1481 (4/1/05)*

##### **16 Del. Admin. Code § 4109-6.0** Confidentiality of Reports {#sec-4109-6.0 omnilex-key=us-de-regs-official--title-16--4109-6.0}

6.1 No report of a diagnosis or treatment of confirmed autism received by the Division shall be disclosed in such a way as to identify the child who is the subject of the report, or as to identify the child's family. However, patient-identifying information may be exchanged among authorized entities as approved by the Department and upon receipt by the Department of satisfactory assurances by those entities of the preservation of the confidentiality of such information. Those entities will maintain the confidentiality of any information exchanged for the purpose of delivery of program services, evaluation, early intervention and epidemiological investigation.

6.2 No individual or organization providing information pursuant to these regulations shall be held liable for divulging such information to the Division.

6.3 Inclusion on the registry does not determine the eligibility for services through any state agency.

**History**
- *8 DE Reg. 1481 (4/1/05)*

##### **16 Del. Admin. Code § 4109-7.0** Penalties {#sec-4109-7.0 omnilex-key=us-de-regs-official--title-16--4109-7.0}

Any person or organization required to report the diagnosis or treatment of confirmed autism pursuant to these regulations, and who violates these regulations, shall be subject to a fine of up to $100 for each violation, pursuant to 16 Del.C. 226. Justices of the Peace Courts have jurisdiction over such violations.

**History**
- *8 DE Reg. 1481 (4/1/05)*

##### **16 Del. Admin. Code § 4109-8.0** Severability {#sec-4109-8.0 omnilex-key=us-de-regs-official--title-16--4109-8.0}

In the event any particular clause or section of the regulations should be declared invalid or unconstitutional by any court of competent jurisdiction, the remaining portions shall remain in full force and effective.

APPENDIX A

DELAWARE AUTISM REGISTRY REPORTABLE DIAGNOSES

Broad Categories Specific Categories Codes

Autism spectrum ICD-9

disorder (ASD) Infantile autism 299.0

Infantile autism, active state 299.00

Infantile autism, residual state 299.01

DSM-IV

Autistic disorder 299

Childhood disintegrative disorder 299.1

Rett's Disorder 299.8

Asperger's Disorder 299.8

Pervasive developmental disorder NOS 299.8

**History**
- *8 DE Reg. 1481 (4/1/05)*

#### **4110** Pharmacists Dispensing and Administering Contraceptives

##### **16 Del. Admin. Code § 4110-1.0** Purpose {#sec-4110-1.0 omnilex-key=us-de-regs-official--title-16--4110-1.0}

These regulations are adopted by the Secretary of Delaware Health and Social Services pursuant to 16 Del.C. §§3001O-3003O. These regulations establish requirements, standard procedures, and conditions under which pharmacists may dispense or dispense and administer contraceptives.

**History**
- *27 DE Reg. 609 (02/01/24)*

##### **16 Del. Admin. Code § 4110-2.0** Definitions {#sec-4110-2.0 omnilex-key=us-de-regs-official--title-16--4110-2.0}

The following words and terms, when used in this regulation, shall have the following meanings:

"Accreditation Council for Pharmacy Education" or "ACPE" means the non-profit accreditation national agency recognized by the Council on Higher Education Accreditation and the U.S. Department of Education. The ACPE accredits and pre-accredits schools offering PharmD degrees and providers of continuing pharmacy education.

"Contraceptives" means medications approved by the Food and Drug Administration to prevent pregnancy.

"Healthcare practitioner" means an individual licensed and authorized to write medical orders for an individual under Title 24 of the Delaware Code.

"Injectable hormonal contraceptive" means a medication composed of a hormone or a combination of hormones that is approved by the U.S. Food and Drug Administration to prevent pregnancy and is administered by injection.

"Pharmacist" means an individual licensed under 24 Del.C. Ch. 25 to engage in the practice of pharmacy.

"Self-screening tool" means a patient self-assessment questionnaire.

"United States Medical Eligibility Criteria for Contraceptive Use" or "USMEC" as issued by the Centers for Disease Control and Prevention, is available in its current version at the following link: https://www.cdc.gov/reproductivehealth/contraception/contraception_guidance.htm

**History**
- *27 DE Reg. 609 (02/01/24)*

##### **16 Del. Admin. Code § 4110-3.0** Pharmacist Education and Training {#sec-4110-3.0 omnilex-key=us-de-regs-official--title-16--4110-3.0}

3.1 Prior to dispensing contraceptives or administering injectable hormonal contraception under this regulation, the pharmacist shall have completed education:

3.1.1 Related to dispensing and administering contraceptives, including:

3.1.1.1 Application of the USMEC; and

3.1.1.2 Other guidance on contraception as provided by the Centers for Disease Control and Prevention.

3.1.2 In the form of:

3.1.2.1 A training program offered by an ACPE-accredited provider of continuing pharmacy education; or

3.1.2.2 A curriculum-based training program completed in an ACPE-eligible or ACPE-accredited school of pharmacy.

**History**
- *27 DE Reg. 609 (02/01/24)*

##### **16 Del. Admin. Code § 4110-4.0** Patient Eligibility {#sec-4110-4.0 omnilex-key=us-de-regs-official--title-16--4110-4.0}

4.1 Patients eligible for contraception under this regulation are adults and individuals that are determined to be eligible under 13 Del.C. §§707 - 710.

4.2 A patient must attest to having seen a healthcare practitioner within 3 years of the initial dispensation or administration of contraception to continue to receive contraception under these regulations.

4.3 Ineligible patients. Patients identified by a pharmacist to be ineligible for contraceptives based on the self-screening tool shall:

4.3.1 Not receive contraception under these regulations;

4.3.2 Be advised why they are ineligible to receive contraception under these regulations; and

4.3.3 Be referred to their health-care practitioner for further evaluation.

**History**
- *27 DE Reg. 609 (02/01/24)*

##### **16 Del. Admin. Code § 4110-5.0** Procedures {#sec-4110-5.0 omnilex-key=us-de-regs-official--title-16--4110-5.0}

5.1 Screening and eligibility

5.1.1 Patients shall be provided with a self-screening tool to complete.

5.1.1.1 A copy of the completed self-screening tool shall be securely stored within the originating pharmacy or healthcare facility for a period of at least 3 years from the date of dispensation or administration of the contraception.

5.1.1.2 The patient shall complete the self-screening tool annually at minimum.

5.1.2 If combined hormonal contraceptives are dispensed, a seated blood pressure measurement is recorded.

5.1.3 A pharmacist shall use the screening tool to determine eligibility for contraceptive use.

5.2 Product selection, dispensation, and administration

5.2.1 The pharmacist, in consultation with the patient, may dispense any non-hormonal contraceptive.

5.2.2 The pharmacist, in consultation with the patient, may dispense any hormonal contraceptive listed in the current USMEC for individuals with:

5.2.2.1 Conditions for which there is no restriction for the use of the contraceptive method ("Category 1"); or

5.2.2.2 Conditions for which the advantages of using the method generally outweigh the theoretical or proven risk ("Category 2").

5.2.3 The pharmacist may administer injectable hormonal contraceptives prescribed by healthcare practitioners or dispensed by a pharmacist.

5.2.4 The pharmacist must dispense the contraceptive or dispense and administer the contraceptive as soon as practicable after the pharmacist determines that the patient meets the requirements under the written standing order created by the Department of Health and Social Services.

5.3 Information provided to patient. The pharmacist shall provide the patient with:

5.3.1 A record of the encounter, including the patient’s self-screening tool;

5.3.2 A record of the contraceptive dispensed or dispensed and administered or the basis for not dispensing or dispensing and administering a contraceptive; and

5.3.3 Written information about the importance of seeing the patient's healthcare practitioner to obtain recommended tests and screenings.

5.4 Referrals and follow-up care. A pharmacist shall refer the patient for appropriate follow-up care to the patient's healthcare practitioner or clinic in the following circumstances:

5.4.1 Upon dispensing a contraceptive to the patient; or

5.4.2 Upon determining ineligibility for contraception.

5.5 Documentation

5.5.1 Each contraceptive dispensed or administered by a pharmacist pursuant to this regulation shall be documented in a patient record and securely stored within the originating pharmacy or healthcare facility for a period of at least 3 years from the dispensed date.

5.5.2 A patient medication record shall be maintained in an automated data processing or manual record mode such that the required information under subsection 5.5.1 of this regulation is readily retrievable during the pharmacy’s or facility's normal operating hours.

**History**
- *27 DE Reg. 609 (02/01/24)*

##### **16 Del. Admin. Code § 4110-6.0** Severability {#sec-4110-6.0 omnilex-key=us-de-regs-official--title-16--4110-6.0}

If any provision or application of any provision of these regulations is held invalid, that invalidity shall not affect the validity of other provisions or applications of these regulations.

**History**
- *27 DE Reg. 609 (02/01/24)*

##### **16 Del. Admin. Code § 4110-7.0** Penalty {#sec-4110-7.0 omnilex-key=us-de-regs-official--title-16--4110-7.0}

Violators are subject to sanctions pursuant to 16 Del.C. §107 for each violation of the requirements established in these regulations.

**History**
- *27 DE Reg. 609 (02/01/24)*

#### **4200** Health Promotion and Disease Prevention

#### **4201** Cancer Registry

##### **16 Del. Admin. Code § 4201-1.0** Purpose {#sec-4201-1.0 omnilex-key=us-de-regs-official--title-16--4201-1.0}

These regulations are promulgated by the Department pursuant to Senate Bill 372 of the 141st General Assembly. These regulations are also independently authorized by 29 Del.C. §7903. The purpose of the regulations is to implement 16 Del.C. Ch. 32.

**History**
- *6 DE Reg. 958 (2/1/03)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*

##### **16 Del. Admin. Code § 4201-2.0** Definitions {#sec-4201-2.0 omnilex-key=us-de-regs-official--title-16--4201-2.0}

“Benign Tumor” means any nonmalignant neoplasm, regardless of the tissue or origin, that appears on the American College of Surgeons most recently published list of reportable cancers and benign tumors.

“Cancer” means any malignant neoplasm, regardless of the tissue origin, that appears on the American College of Surgeons most recently published annual list of reportable cancers and benign tumors.

“Clinical Laboratory” means a facility in which tests are performed identifying findings of anatomical changes, and/or specimens are interpreted and pathological diagnoses are made.

“The Department” means the Department of Health and Social Services.

“Health Care Provider” means:

person, corporation, facility or institution licensed by this State pursuant to Titles 16 or 24 of the Delaware Code to perform any act to or on behalf of a patient during the patient’s medical care, treatment, or confinement, or

a clinical laboratory. When a person acting as a health care provider is working for a corporation, facility, or institution, the corporation, facility, or institution shall be considered the health care provider for purposes of these regulations.

“Non-hospital reporter” means one that: is not located within a Delaware hospital and/or does not report cancer case data to such hospital’s cancer registry.

**History**
- *6 DE Reg. 958 (2/1/03)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*

##### **16 Del. Admin. Code § 4201-3.0** Duty to Report {#sec-4201-3.0 omnilex-key=us-de-regs-official--title-16--4201-3.0}

Each health care provider shall submit cancer data to the Department electronically as described in Section 4.0 with respect to (a) each patient whom it diagnoses with cancer or a benign tumor, and (b) each patient for whom it renders any care after the individual is diagnosed with cancer or a benign tumor. Compliance by one health care provider with this Section with respect to an individual patient shall not obviate compliance by other health care providers with respect to the same patient. Physician offices that are located in a hospital and have an electronic database accessible to the hospital cancer registry may be asked to submit to the Department an electronic data file listing of cancer cases for linkage prior to submission of case information. Once the linkage is made, any missing cases must be reported electronically as indicated in Section 4.0.

**History**
- *6 DE Reg. 958 (2/1/03)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*

##### **16 Del. Admin. Code § 4201-4.0** Process and Specifications of Reporting Data to the Department {#sec-4201-4.0 omnilex-key=us-de-regs-official--title-16--4201-4.0}

Cancer data should be submitted in a secure, electronic method. Non-hospital providers should submit all cancer case data utilizing the CDC’s Web Plus software. If a non-hospital provider is unable to submit data electronically, the provider may contact the Department to inquire about an exemption. Upon approval of the exemption, the Department will provide data collection forms to the provider. To request an exemption, a provider must submit a letter stating reason why it is unable to report using the electronic method to the Delaware Cancer Registry. The address can be found at:

http://www.dhss.delaware.gov/dhss/main/maps/other/oxfordbd.htm

All data as indicated by the reporting requirements of the National Cancer Data Base established by the American College of Surgeons is required. Data submitted under this section shall also include disclosure of the patient’s length of residency in Delaware, primary residential address in Delaware and the location and nature of the patient’s primary past employment if such information is available to the health care provider. A health care provider shall make reasonable efforts to obtain all information as required on the electronic reporting system. However, reasonable efforts by a clinical laboratory shall not include the interviewing of patients to obtain required information.

**History**
- *6 DE Reg. 958 (2/1/03)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*

##### **16 Del. Admin. Code § 4201-5.0** Retention of Required Information {#sec-4201-5.0 omnilex-key=us-de-regs-official--title-16--4201-5.0}

A health care provider who is treating a patient who has been diagnosed with cancer or a benign tumor shall ask that patient to fill out a form requesting disclosure of patient’s length of residency in Delaware, primary residential address in Delaware and the location and nature of the patient’s primary past employment. The health care provider shall retain the form required by this Section with the patient’s medical records pursuant to generally accepted protocol for the retention of patient medical records. The health care provider shall include the information from the form required by this Section with information it submits pursuant to Section 3.0 of these regulations. The Department shall provide a form for use in complying with this Section.

**History**
- *6 DE Reg. 958 (2/1/03)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*

##### **16 Del. Admin. Code § 4201-6.0** Deadlines for Submission {#sec-4201-6.0 omnilex-key=us-de-regs-official--title-16--4201-6.0}

A health care provider shall provide the information required by Section 4.0 within 180 days of the initiation of treatment of a patient or diagnosis of that patient with a cancer or benign tumor, whichever is earlier.

**History**
- *6 DE Reg. 958 (2/1/03)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*

##### **16 Del. Admin. Code § 4201-7.0** Failure to Submit Required Information {#sec-4201-7.0 omnilex-key=us-de-regs-official--title-16--4201-7.0}

A health care provider that fails to comply with Section 3.0 shall permit the Department to audit its records and abstract information that should have been provided under Section 4.0. The health care provider shall reimburse the Department for the cost of said audit. If the audit does not identify a compliance failure by the health care facility or provider, the cost of such audit shall not be assessed against the facility or provider.

**History**
- *6 DE Reg. 958 (2/1/03)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*

##### **16 Del. Admin. Code § 4201-8.0** Voluntary Audit {#sec-4201-8.0 omnilex-key=us-de-regs-official--title-16--4201-8.0}

A health care provider may voluntarily request that an audit be performed if it does not intend to submit the information required by Section 4.0. The Department shall determine if the request for an audit will be honored. The health care provider shall reimburse the Department for the cost of said audit if the Department honors the request. The Department shall determine whether said costs shall be prepaid, or paid upon completion of the audit.

**History**
- *6 DE Reg. 958 (2/1/03)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*

##### **16 Del. Admin. Code § 4201-9.0** Fines {#sec-4201-9.0 omnilex-key=us-de-regs-official--title-16--4201-9.0}

Failure to comply with Sections 3.0 and 6.0 of these regulations may result in a $100 fine against the health care provider that has failed to comply. Each failure to comply shall constitute a separate violation and shall subject the health care provider to a separate $100 fine.

**History**
- *6 DE Reg. 958 (2/1/03)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*
- *6 DE Reg. 958 (2/1/03)*
- *18 DE Reg. 63 (07/01/14)*

#### **4202** Control of Communicable and Other Disease Conditions

##### **16 Del. Admin. Code § 4202-1.0** Definitions {#sec-4202-1.0 omnilex-key=us-de-regs-official--title-16--4202-1.0}

The following words and terms, when used in this regulation, have the following meaning:

“Case" means a person whose body has been invaded by an infectious agent with the result that clinical symptoms have occurred.

"CDC" means the Centers for Disease Control and Prevention an agency of the United States Department of Health and Human Services that works to protect public health and safety by providing information to enhance health decisions and promoting health through partnerships with state health departments and other organizations. The CDC is dedicated to protecting health and promoting quality of life through the prevention and control of disease, injury, and disability. As the national public health agency for the United States, the CDC is committed to programs that reduce the health and economic consequences of leading causes of death and disability, thereby ensuring a long, productive, healthy life for all people. The CDC provides the standard national measures for healthcare-associated infections as well as analytic tools that enable each facility to assess its progress and identify where additional prevention or response efforts are needed.

"Child care facility" means any organization or business created for, and having as its major purpose, the daily care or education of children under the age of 7 years.

"Communicable disease" see “Contagious disease”.

"Contact" means a person or animal that has been in such association with an infected person or animal or a contaminated environment as to have had exposure to the infection.

"Contagious disease" means an infectious disease that can be transmitted from person to person, or animal to person.

“Designee” means the person named by the Director of the Division of Public Health to assume a specific responsibility.

"Division" or “DPH” means the Delaware Division of Public Health.

“Division Director” means the Director of the Division of Public Health.

“Directly observed therapy” or “DOT” means an adherence-enhancing strategy in which a health care worker or other designated person observes the patient to ensure each dose of medication is swallowed.

"DPHL" means the Division of Public Health Laboratory.

"Epidemic" means the occurrence in persons in a community, institution, region, or other defined area of cases of an illness of similar nature clearly in excess of normal expectancy.

"Health care provider" means any person or entity who provides health care services, including hospitals, medical clinics and offices, special care facilities, medical laboratories, physicians, pharmacists, dentists, physician assistants, nurse practitioners, registered and other nurses, paramedics, emergency medical or laboratory technicians, and ambulance and emergency medical workers.

“Human immunodeficiency virus” or “HIV” means the presence of repeatedly reactive screening tests for HIV antibody in accord with the CDC case definition of HIV and DPHL endorsed diagnostic protocols.

"Infectious disease" means a disease caused by a living organism or other pathogen, including a fungus, bacillus, parasite, protozoan, or virus. An infectious disease may or may not be transmissible from person to person or animal to person.

"Isolation" means the physical separation and confinement of an individual or group of individuals who are infected or reasonably believed to be infected with a contagious or possibly contagious disease from non-isolated individuals to prevent or limit the transmission of the disease.

"Medical Examiner" means a physician appointed pursuant to 29 Del.C. §4703 or §7903(a)(3) who is authorized to investigate the causes and circumstances of death.

"Nosocomial disease” or “healthcare-associated infection" means a disease occurring in a patient in a healthcare facility and in whom it was not present or incubating at the time of admission.

"Notification" means a written, electronic, or verbal report as required by any section of this regulation.

"Outbreak" - see "Epidemic".

“Public health emergency” is an occurrence or imminent threat of an illness or health condition that is believed to be caused by any of the following:

1. Bioterrorism;

2. The appearance of a novel or previously controlled or eradicated infectious agent or biological toxin; or

3. A chemical attack or accidental release;

And, which poses a high probability of any of the following harms:

1. Many deaths in the affected populations;

2. Many serious or long-term disabilities in the affected population; or

3. Widespread exposure to an infectious or toxic agent that poses a significant risk of substantial future harm to many people in the affected population.

"Quarantine" means the physical separation and confinement of an individual or group of individuals who are or may have been exposed to a contagious or possibly contagious disease but who do not yet show signs or symptoms of the contagious disease from non-quarantined individuals to prevent or limit the transmission of the disease.

"Reportable disease" means an infectious disease or condition of public health significance required to be reported to the Division of Public Health in accordance with this regulation. A subset of reportable diseases is shared with the CDC and referred to as national notifiable conditions.

“Resistant organism” or “drug-resistant organism” means any organism which traditionally was inactivated or killed by a drug but has, over time, developed mechanisms to render that drug ineffective.

"Sensitive situation" means a setting, as determined by the Director of the Division of Public Health or designee, in which the presence of a person or animal infected with or suspected of being infected with a reportable or other communicable disease or condition which may affect the public health would increase significantly the probability of spread of such disease and would, therefore, constitute a public health hazard, but not a public health emergency as defined in 20 Del.C. §3132(11). Sensitive situations may include schools, child care facilities, hospitals, and other patient-care facilities, food storage, food processing establishments or food outlets.

"Source of infection" means the person, animal, object, or substance from which an infectious agent passes directly to the host.

"Suspect" means a person or animal whose medical history and symptoms suggest that the person or animal may have or may be developing an infectious disease condition.

"Syndromic surveillance" means surveillance using signs and symptoms that precede diagnosis and may signal a sufficient probability of a case or an outbreak to warrant further public health response.

**History**
- *9 DE Reg. 1188 (02/01/06)*
- *17 DE Reg. 320 (09/01/13)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *23 DE Reg. 665 (02/01/20)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *12 DE Reg. 1418 (05/01/09)*
- *15 DE Reg. 1163 (02/01/12)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *9 DE Reg. 1188 (02/01/06)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *12 DE Reg. 1418 (05/01/09)*
- *17 DE Reg. 320 (09/01/13)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *12 DE Reg. 1418 (05/01/09)*
- *15 DE Reg. 1163 (02/01/12)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*

##### **16 Del. Admin. Code § 4202-2.0** Conditions to be Reported, Timeliness and Manner of Reporting {#sec-4202-2.0 omnilex-key=us-de-regs-official--title-16--4202-2.0}

2.1 Reportable Diseases Reporting

2.1.1 The reportable diseases specified in the Appendices to this regulation are declared as dangerous to the public health. The occurrence or suspected occurrence of these diseases, including those identified after death, shall be reported as defined in Section 3.0 to the Division of Public Health.

2.1.2 The Division of Public Health may list additional diseases and conditions on its reporting forms for which reporting is encouraged but not required.

2.2 Timeliness and Content of Reportable Disease Reports

2.2.1 Reports pursuant to this subsection shall be made electronically, by telephone, by facsimile (fax), or in writing within 48 hours of recognition to the Division Director or designee, except as otherwise noted in this regulation or specified in the Appendices to this regulation.

2.2.2 Except as otherwise provided by this regulation, reports of reportable or other diseases or conditions required to be reported by this regulation shall contain sufficient information to contact the person reporting. The following information shall be reported: the name, address, telephone number, date of birth, race, ethnicity, gender, and disease of the person ill or infected, the date of onset of illness; the name, address, and telephone number of the person's health care provider; and any pertinent laboratory information.

2.3 Ordinary Skill

2.3.1 Any person who is required to report a disease or other condition under this section shall use ordinary skill in determining the presence of the reportable disease or condition.

2.3.2 If the determination of the disease or condition is disputable and the disease or condition may have potential public health concern or may potentially be an indicator of a public health emergency, the Division Director or designee may request tests through the Division's laboratory or another certified laboratory to help resolve uncertainty.

2.4 Privacy Protection

2.4.1 The Division of Public Health is the state's recognized public health authority as defined in HIPAA (45 CFR § 164.501) pursuant to 45 CFR § 164.512 (b).

2.4.2 Covered entities may disclose without individual authorization, protected health information to public health authorities.

2.4.3 As the recognized public health authority for the State of Delaware, the Division of Public Health is authorized by law to collect or receive protected health information for the purpose of preventing or controlling disease, injury or disability, including, but not limited to, the reporting of disease, injury, vital events such as birth or death, and the conduct of public health surveillance, public health investigations, and public health interventions.

2.4.4 The information required to be reported represents the minimum necessary to carry out our public health mandates pursuant to 45 CFR § 164.514(d) of the HIPAA Privacy Rule.

2.5 Electronic Reporting Systems

2.5.1 The Division may establish a system for electronic reporting to improve the accuracy and timeliness of reporting diseases defined by state law as reportable. The system shall be technologically designed to ensure data security and compatibility with other state and federal public health reporting systems to the extent feasible.

2.5.2 Those authorized to participate in electronic reporting systems must meet minimum standards for compliance and training as determined by the Division.

2.6 Syndromic Surveillance Reporting

2.6.1 The Division may establish a statewide syndromic surveillance system. The system shall be technologically designed to ensure data security and compatibility with other state and federal public health reporting systems to the extent feasible.

2.6.2 Those authorized to participate in syndromic surveillance must meet minimum standards for compliance and training as determined by the Division. In addition, syndromic surveillance data shall include the patient's name, address, date of birth, race, ethnicity, and gender.

2.6.3 The Director will establish what syndromes will be reported. The Director may change or add reportable syndromes to assure the monitoring of health events of public health importance.

**History**
- *9 DE Reg. 1188 (02/01/06)*
- *17 DE Reg. 320 (09/01/13)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *23 DE Reg. 665 (02/01/20)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *12 DE Reg. 1418 (05/01/09)*
- *15 DE Reg. 1163 (02/01/12)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *9 DE Reg. 1188 (02/01/06)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *12 DE Reg. 1418 (05/01/09)*
- *17 DE Reg. 320 (09/01/13)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *12 DE Reg. 1418 (05/01/09)*
- *15 DE Reg. 1163 (02/01/12)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*

##### **16 Del. Admin. Code § 4202-3.0** Report of Outbreaks and Potential Causes of a Public Health Emergency {#sec-4202-3.0 omnilex-key=us-de-regs-official--title-16--4202-3.0}

3.1 Outbreaks. Any health care provider, having knowledge of any outbreak of any reportable disease, cluster of any illness which may be of public concern, or any unusual group expression or individual case of a disease of public concern as determined by the Division Director, is required to report such occurrences within 24 hours to the Division Director or designee.

3.2 Public Health Emergencies

3.2.1 A health care provider or any other person having knowledge of a public health emergency shall immediately report all cases of persons who harbor any illness or health condition, or symptoms of said illness or health condition, that may be potential causes of a public health emergency. The Division Director or designee may declare certain illnesses or health conditions as public health emergencies, which shall be reported.

3.2.2 A pharmacist shall report any unusual or increased prescription rates, unusual types of prescriptions, or unusual trends in pharmacy visits that may be potential causes of a public health emergency. Prescription-related events that require a report include:

3.2.2.1 An unusual increase in the number of prescriptions to treat fever, respiratory or gastrointestinal complaints;

3.2.2.2 An unusual increase in the number of prescriptions for antibiotics or other pharmaceuticals or sales of over-the-counter pharmaceuticals; and

3.2.2.3 Any prescription that treats a disease that is relatively uncommon or may be associated with terrorism.

**History**
- *9 DE Reg. 1188 (02/01/06)*
- *17 DE Reg. 320 (09/01/13)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *23 DE Reg. 665 (02/01/20)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *12 DE Reg. 1418 (05/01/09)*
- *15 DE Reg. 1163 (02/01/12)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *9 DE Reg. 1188 (02/01/06)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *12 DE Reg. 1418 (05/01/09)*
- *17 DE Reg. 320 (09/01/13)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *12 DE Reg. 1418 (05/01/09)*
- *15 DE Reg. 1163 (02/01/12)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*

##### **16 Del. Admin. Code § 4202-4.0** Persons and Institutions Required to Report {#sec-4202-4.0 omnilex-key=us-de-regs-official--title-16--4202-4.0}

4.1 Health Care Providers

4.1.1 Reports required by Sections 2.0 and 3.0 shall be made to the Division Director or designee by the following:

4.1.1.1 Any health care provider who diagnoses or suspects the existence of any disease required to be reported; or

4.1.1.2 The medical examiner in such cases that the medical examiner examines.

4.2 Hospitals

4.2.1 The chief administrative officer of each civilian hospital, long-term care facility, or other patient-care facility shall (and the United States military and Veterans Administration Hospitals are requested to) appoint an individual from the staff, hereinafter referred to as "reporting officer," who shall be responsible for reporting cases or suspect cases of diseases on the reportable disease list in persons admitted to, attended to, or residing in the facility.

4.2.2 Reporting of a case or suspect case of a reportable disease by a hospital fulfills the requirements of the health care provider to report; however, it is the responsibility of the attending practitioner to ensure that the report is made pursuant to subsection 4.1.

4.2.3 The hospital reporting officer shall also report to the Division Director or designee communicable diseases not specified in Section 2.0, should the disease occur in a nosocomial disease outbreak situation that may significantly impact the public health. Such reports shall be made within 24 hours of the recognition of such a situation.

4.2.4 Hospitals shall make a good effort to meet the technologic standards provided by the Division to report reportable diseases electronically per subsection 2.5 and syndromic surveillance data per subsection 2.6. Hospitals meeting said standards shall use this method of reporting.

4.3 Laboratories

4.3.1 Any person in charge of a clinical or hospital laboratory or other facilities in which a laboratory examination of any specimen derived from a human body and submitted for examination shall share with the DPHL specimens or culture results for agents causing certain diseases listed in the Appendices of this regulation. In addition, such laboratories shall report to the Division of Public Health results of laboratory examinations of specimens indicating or suggesting the existence of:

4.3.1.1 A reportable disease;

4.3.1.2 A suspected agent of bioterrorism immediately upon receipt of the results; or

4.3.1.3 Any other potential agent or specimen that may be the cause of an outbreak or public health emergency immediately upon receipt of the results.

4.3.2 The Director or designee may contact the patient or the potential contacts so identified from laboratory reports only after consulting with the attending practitioner, when the practitioner is known and when said consultation will not delay the timely control of a communicable disease.

4.3.3 Reporting of antibiotic resistant organisms

4.3.3.1 Any person in charge of a clinical or hospital laboratory, or other facility in which a laboratory examination of any specimen derived from a human body and submitted for microbiologic examination yields a non-susceptible species of microorganism identified in Appendix I by (A), will report the infected person's name, address, date of birth, race, ethnicity, sex, site of isolation, date of isolation and Minimum Inhibitory Concentration and Zone of Inhibition (MIC/Zone) diameter to the Division of Public Health.

4.3.3.2 Upon request, the Division may waive the requirement for the reporting of said demographic information until such time that electronic reporting facilitates its reporting.

4.3.3.3 The number of susceptible and non-susceptible isolates of any of these organisms shall be reported monthly to the Division of Public Health.

4.3.4 Laboratories authorized to report reportable diseases electronically per subsection 2.5, shall use this method of reporting.

4.4 Others

4.4.1 In addition to those who are required to report reportable diseases, the following individuals are requested and authorized to notify the Division Director or designee of the name and address of any person in the individual’s family, care, employ, class, jurisdiction, or custody of control, who is suspected of being afflicted with a reportable disease although no health care provider, as in subsection 4.1 of this regulation, has been consulted:

4.4.1.1 Every parent, guardian, householder;

4.4.1.2 Every midwife;

4.4.1.3 Every superintendent, principal, teacher, or counselor of a public or private school;

4.4.1.4 Every administrator of a public or private institution of higher learning;

4.4.1.5 Every owner, operator, or teacher of a child care facility;

4.4.1.6 Every owner or manager of a dairy, restaurant, or food storage, food-processing establishment, or food outlet;

4.4.1.7 Every superintendent or manager of a public or private camp, home, or institution; and

4.4.1.8 Every director or supervisor of a military installation, military or Veterans Administration hospital, prison, or juvenile detention center.

**History**
- *9 DE Reg. 1188 (02/01/06)*
- *17 DE Reg. 320 (09/01/13)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *23 DE Reg. 665 (02/01/20)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *12 DE Reg. 1418 (05/01/09)*
- *15 DE Reg. 1163 (02/01/12)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *9 DE Reg. 1188 (02/01/06)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *12 DE Reg. 1418 (05/01/09)*
- *17 DE Reg. 320 (09/01/13)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *12 DE Reg. 1418 (05/01/09)*
- *15 DE Reg. 1163 (02/01/12)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*

##### **16 Del. Admin. Code § 4202-5.0** Investigation of Case {#sec-4202-5.0 omnilex-key=us-de-regs-official--title-16--4202-5.0}

5.1 Action to Be Taken

5.1.1 Upon being notified of a case or suspected case of a reportable disease or an outbreak of a reportable disease or other disease condition in persons or animals, the Director of the Division or designee may act as permitted in this regulation, and additionally as deemed necessary to protect the public health.

5.1.2 If the nature of the disease and the circumstances warrant, the Director of the Division or designee may make or cause to be made an examination of the patient to verify the diagnosis, make an investigation to determine the source of infection, and take other appropriate action to prevent or control the spread of the disease. These actions may include:

5.1.2.1 Confinement on a temporary basis until the patient is no longer infectious; and

5.1.2.2 Obligatory medical treatment in order to prevent the spread of disease in the community.

5.2 Examination of Patient

5.2.1 Any person suspected of being afflicted with any reportable disease shall be subject to physical examination and inspection by any designated representative of the Division of Public Health, except that a duly authorized warrant or court order shall be presented to show just cause in instances where the suspect refuses such examination and inspection.

5.2.2 Such examination shall include the submission of bodily specimens when deemed necessary by the Division Director or designee.

5.3 Sensitive Situations

5.3.1 No person known to be infected with a contagious disease or suspected of being infected with a contagious disease shall engage in sensitive situations as defined in Section 1.0 of this regulation until judged by the Division Director or designee to be either free of such disease or no longer a threat to public health. Such action shall be in accord with accepted public health practice and reasonably calculated to abate the potential public health risk.

5.3.2 When, pursuant to subsection 5.3.1, it is necessary to require that a person not engage in a sensitive situation because that person is infected or suspected of being infected with a contagious disease, the Division Director or designee shall provide, in writing, instructions specifying the nature of the restrictions and conditions necessary to terminate the restrictions.

5.3.2.1 These written instructions shall be provided to the person infected or suspected of being infected with a contagious disease and to that person's employer or other such individual responsible for the sensitive situation.

5.3.3 The Division Director or designee shall have the authority to exclude from attendance in a child care facility any child or employee suspected of being infected with a contagious disease that, in the opinion of the Division Director or designee, significantly threatens the public health. In addition, no person shall attend or be employed in a child care facility who has the following symptoms:

5.3.3.1 Diarrhea, severe coughing, difficult or rapid breathing, yellowish skin or eyes, pinkeye, or an untreated louse or scabies infestation;

5.3.3.2 Fever (100°F by oral thermometer or 101°F by rectal thermometer or higher) accompanied by 1 of the following: unusual spots or rashes, sore throat or trouble swallowing, infected skin patches, unusually dark tea-colored urine, gray or white stool, headache and stiff neck, vomiting, unusually cranky behavior, or loss of appetite.

5.3.3.3 Any other symptoms that, in the opinion of the Division Director or designee, suggest the presence of a contagious disease that significantly threatens the public health. Exclusion from a child care facility in this case shall be effective upon written notification pursuant to subsection 5.3.2.

**History**
- *9 DE Reg. 1188 (02/01/06)*
- *17 DE Reg. 320 (09/01/13)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *23 DE Reg. 665 (02/01/20)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *12 DE Reg. 1418 (05/01/09)*
- *15 DE Reg. 1163 (02/01/12)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *9 DE Reg. 1188 (02/01/06)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *12 DE Reg. 1418 (05/01/09)*
- *17 DE Reg. 320 (09/01/13)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *12 DE Reg. 1418 (05/01/09)*
- *15 DE Reg. 1163 (02/01/12)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*

##### **16 Del. Admin. Code § 4202-6.0** Quarantine and Isolation {#sec-4202-6.0 omnilex-key=us-de-regs-official--title-16--4202-6.0}

6.1 The Division's authority may exercise the following over persons:

6.1.1 To establish and maintain places of isolation and quarantine;

6.1.2 To isolate and quarantine individuals subject to the procedures enumerated in this section; and

6.1.3 To require isolation or quarantine of any person by the least restrictive means necessary to protect the public health, subject to the other provisions of this section. All reasonable means shall be taken to prevent the transmission of infection among the isolated or quarantined individuals.

6.2 Standard for quarantine or isolation

6.2.1 Persons shall be isolated or quarantined if it is determined by clear and convincing evidence that the person to be isolated or quarantined poses a significant risk of transmitting a disease to others with serious consequences. A person's refusal to accept medical examination, vaccination or treatment shall constitute prima facie evidence that said person should be quarantined or isolated.

6.2.2 Isolation or quarantine of any person shall be terminated when such person no longer poses a significant risk of transmitting a disease to others with serious consequences.

6.3 Character of isolation and quarantine area

6.3.1 To the extent possible, the premises in which persons are isolated or quarantined shall be maintained in safe and hygienic manners designed to minimize the likelihood of further transmission of infection or other harm to persons subject to isolation or quarantine. Adequate food, clothing, medication and other necessities and competent medical care shall be provided.

6.3.2 Isolated individuals must be confined separately from quarantined individuals.

6.3.3 The health status of isolated and quarantined individuals must be monitored regularly to determine if their status should change. If a quarantined individual subsequently becomes infected or is reasonably believed to have become infected with a contagious or possibly contagious disease, the individual must promptly be moved to isolation.

6.4 Transportation

6.4.1 Transportation or removal of quarantined or isolated persons may be made only with prior approval of the Division Director or designee.

6.4.2 Transportation or removal of quarantined or isolated persons shall be made in accordance with orders issued by the Division Director or designee. Quarantine or isolation shall be resumed immediately upon arrival of quarantined or isolated person at point of destination for a time period in accord with accepted public health practices.

6.5 Disinfection

6.5.1 Concurrent disinfection is required of infectious or potentially infectious secretions or excretions of any quarantined or isolated person or animal or of objects contaminated by such secretions or excretions. The collection, storage, and disposal of such contaminated matter and disinfection procedures shall be approved by the Division Director or designee.

6.5.2 Disinfection shall also be carried out at the termination of the period of quarantine or isolation and shall be applied to the quarter vacated. The disinfection procedures shall be as approved by the Division Director or designee.

6.6 Control of quarantine and isolation area

6.6.1 A person subject to isolation or quarantine shall obey the Division's rules and orders, shall not go beyond the isolation or quarantine premises, and shall not put themselves in contact with any person not subject to isolation or quarantine other than a physician or other health care provider, public health authority, or person authorized to enter isolation or quarantine premises by the Division's authority. Any person entering isolation or quarantine premises may be isolated or quarantined.

6.6.2 No person, other than a person authorized by the Division, shall enter isolation or quarantine premises. If by reason of an unauthorized entry into an isolation or quarantine premises, the person poses a danger to public health, that person may be subject to isolation or quarantine pursuant to the provisions of this section.

6.7 Procedures for isolation and quarantine. The following procedures shall protect the due process rights of individuals:

6.7.1 The Division shall petition the Superior Court for an order authorizing the isolation or quarantine of an individual or groups of individuals. Said petition shall specify the following:

6.7.1.1 The identity of the individual or group of individuals subject to isolation or quarantine;

6.7.1.2 The premises subject to isolation or quarantine;

6.7.1.3 The date and time at which the Division requests isolation or quarantine to commence;

6.7.1.4 The suspected contagious disease, if known;

6.7.1.5 A statement of compliance with the conditions and principles for isolation and quarantine;

6.7.1.6 A statement of the basis upon which isolation or quarantine is justified; and

6.7.1.7 A statement of what effort, if any, has been made to give notice of the hearing to the individual or group of individuals to be isolated or quarantined, or the reason supporting the claim that notice should not be required.

6.7.2 Ex parte orders

6.7.2.1 Before isolating or quarantining a person, the Division shall obtain a written order, which may be an ex parte order, from the Superior Court authorizing such action. An order, which may be an ex parte order, shall be requested as part of a petition filed in compliance with subsections 6.1 through 6.2.

6.7.2.2 The Court shall grant an order, which may be an ex parte order, upon finding by clear and convincing evidence that isolation or quarantine is warranted pursuant to the provisions of Section 6.0 of this regulation.

6.7.2.3 A copy of the authorizing order shall be given to the person ordered to be isolated or quarantined, along with notification that the person has a right to a hearing under subsection 6.7.

6.7.3 Temporary quarantine or isolation pending filing of a petition

6.7.3.1 Notwithstanding the preceding subsections, the Division may isolate or quarantine a person without first obtaining a written order, which may be an ex parte order, from the Court if a physician determines that any delay in the isolation or quarantine of the person would pose an immediate and severe danger to the public health.

6.7.3.2 Following such isolation or quarantine, the Division shall file a petition within 24 hours.

6.7.3.3 If the Division exercises its powers, it must provide a written directive to the individuals or groups under temporary quarantine or isolation indicating the identities of the individuals or groups subject to the directive, the premises subject to isolation or quarantine, the date and time that the directive commences, and the suspected contagious disease (if known).

6.7.4 Speedy hearing. The Court shall grant a hearing within 72 hours of the filing of a petition when an individual has been isolated or quarantined.

6.7.5 Consolidation of claims. The Court may order consolidation of individual claims into a group of claims where:

6.7.5.1 The number of individuals involved or to be affected is so large as to render individual participation impractical;

6.7.5.2 There are questions of law or fact common to the individual claims or rights to be determined;

6.7.5.3 The group claims or rights to be determined are typical of the affected individuals' claims or rights; and

6.7.5.4 The entire group will be adequately represented in the consolidation, giving due regard to the rights of affected individuals.

6.8 Relief for isolated and quarantined persons

6.8.1 On or after 10 days following a hearing, a person isolated or quarantined pursuant to the provisions of this section may request in writing a Court hearing to contest the person’s continued isolation or quarantine.

6.8.1.1 The hearing shall be held within 72 hours of receipt of such request, excluding Saturdays, Sundays, and legal holidays.

6.8.1.2 A request for a hearing shall not alter the order of isolation or quarantine.

6.8.1.3 At the hearing, the Division must show by clear and convincing evidence that continuation of the isolation or quarantine is warranted because the person poses a significant risk of transmitting a disease to others with serious consequences.

6.8.2 A person isolated or quarantined pursuant to the provisions of this section may request a hearing in the Superior Court for remedies regarding the person’s treatment and the terms and conditions of such quarantine or isolation.

6.8.2.1 Upon receiving a request for either type of hearing, the Court shall fix a date for a hearing. The hearing shall take place within 10 days of the receipt of the request by the Court.

6.8.2.2 The request for a hearing shall not alter the order of isolation or quarantine.

6.8.3 If upon a hearing, the Court finds that the isolation or quarantine of the individual is not warranted under the provisions of this section, then the person shall be immediately released from isolation or quarantine. If the Court finds that the isolation or quarantine of the individual is not in compliance with the provisions of this section, the Court may then fashion remedies appropriate to the circumstances of the necessity for the isolation or quarantine and in keeping with the provisions of this section.

6.8.4 No person shall be permanently terminated from employment by a Delaware employer as a result of being isolated or quarantined pursuant to this section. However, this paragraph shall not apply to a person who has been quarantined as a result of refusing to comply with an examination, treatment, or vaccination program, nor shall it apply to a person whose conduct caused the necessity for the isolation or quarantine.

6.9 Additional due process protections

6.9.1 A record of proceedings before the Court shall be made and retained for at least 3 years.

6.9.2 The petitioner shall have the right to be represented by counsel or other lawful representative, and the State shall provide counsel to indigent persons against whom proceedings are initiated pursuant to this section.

6.9.3 The manner in which the request for a hearing is filed and acted upon will be in accordance with the existing laws and rules of the Superior Court or any such rules that are developed by the Court, provided that hearings should be held by any means that will allow all necessary persons to participate in the event that a public health emergency makes personal appearances impractical.

6.10 The provisions of this section are subject to the provisions of 16 Del.C. §§520-532. Provisions of 16 Del.C. §§520-532 that conflict with provisions of this section take precedence over this section.

**History**
- *9 DE Reg. 1188 (02/01/06)*
- *17 DE Reg. 320 (09/01/13)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *23 DE Reg. 665 (02/01/20)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *12 DE Reg. 1418 (05/01/09)*
- *15 DE Reg. 1163 (02/01/12)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *9 DE Reg. 1188 (02/01/06)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *12 DE Reg. 1418 (05/01/09)*
- *17 DE Reg. 320 (09/01/13)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *12 DE Reg. 1418 (05/01/09)*
- *15 DE Reg. 1163 (02/01/12)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*

##### **16 Del. Admin. Code § 4202-7.0** Control of Specific Contagious Diseases {#sec-4202-7.0 omnilex-key=us-de-regs-official--title-16--4202-7.0}

7.1 Vaccine Preventable Diseases

7.1.1 All preschool children who are enrolled in a child care facility must be age-appropriately vaccinated against diseases prescribed by the Division Director.

7.1.1.1 For those diseases so prescribed, the most current recommendations of the federal Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) shall determine the vaccines and vaccination schedules acceptable for compliance with this regulation.

7.1.2 Any child entering private school must be age-appropriately vaccinated against diseases prescribed by the Division Director, prior to enrolling in school.

7.1.2.1 For those diseases so prescribed, the most current recommendations of the federal Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) shall determine the vaccines and vaccination schedules acceptable for compliance with this regulation.

7.1.2.2 This provision pertains to all children between the ages of 2 months and 21 years entering or being admitted to a Delaware private school for the first time including foreign exchange students, immigrants, students from other states and territories and children entering from public schools.

7.1.3 Acceptable documentation of the receipt of immunization as required by subsections 7.1.1 and 7.1.2 shall include either a medical record signed by a physician, or a valid immunization record issued by the State of Delaware or another State, which specifies the vaccine given and the date of administration.

7.1.4 Immunization requirements pursuant to subsections 7.1.1 and 7.1.2 shall be waived for:

7.1.4.1 Children whose physicians have submitted, in writing, that a specific immunizing agent would be detrimental to that child; and

7.1.4.2 Children whose parents or guardians present a notarized document that immunization is against their religious beliefs.

7.1.5 Child care facilities and private schools (grades K-12) shall maintain on file an immunization record for each child. The facility will also be responsible to report to the Division Director or designee on an annual basis the immunization status of its enrollees.

7.1.6 Parents whose children present immunization records which show that immunizations are lacking will be allowed 14 days (or such time as may be appropriate for a particular vaccination) to complete the required age-appropriate doses of vaccine for their children.

7.1.6.1 In instances where more than 14 days will be necessary to complete the age-appropriate immunization schedule, an extension may be allowed in order to obtain the required immunizations. Extension of the 14-day allowance because of missed appointments to receive needed immunizations shall not be permitted.

7.1.7 When a child's records are lost and the parent states that the child has completed the child’s series of immunizations, or a child has been refused admission or continued attendance at a child care facility or private school for lack of acceptable evidence of immunization as specified in this regulation, a written certification must be provided by a health care provider who has administered the necessary age-appropriate immunizations to the child according to the current ACIP immunization schedule.

7.1.8 It is the responsibility of the child care facility or private school to exclude a child prior to admission or from continued attendance who has failed to document required immunizations pursuant to this section.

7.1.9 Upon the occurrence of a case or suspect case of 1 of the vaccine preventable diseases specified in pursuant to subsections 7.1.1 and 7.1.2, any child not immunized against that disease shall be excluded from the premises until the Division Director or designee has determined that the disease risk to the unimmunized child has passed.

7.1.9.1 Such exclusion shall apply to all those in the facility who are admitted under either medical or religious exemption as well as to those previously admitted who have not yet received vaccine against the disease which has occurred.

7.1.9.2 If, in the judgment of the Division Director or designee, the continued operation of the facility presents a risk of the spread of disease to the public at large, the Division Director or designee shall have the authority to close the facility until the risk of disease occurrence has passed.

7.1.10 All full-time students of post-secondary educational institutions (including post-high school institutions of education/training, such as universities, private colleges, technical and community colleges, vocational technical schools, and hospital nursing schools) and all full and part-time students in such educational institutions if engaged in patient-care related curriculums (including nursing, dentistry, and medical laboratory technology), shall be required to show evidence of immunity to measles, rubella, and mumps prior to enrollment by the following criteria:

7.1.10.1 Measles immunity:

7.1.10.1.1 Persons born before January 1, 1957; or

7.1.10.1.2 Physician documented history of measles disease; or

7.1.10.1.3 Serological confirmation of measles immunity; or

7.1.10.1.4 A documented receipt from a physician or health facility that 2 doses of measles vaccine were administered after 12 months of age.

7.1.10.2 Rubella immunity:

7.1.10.2.1 Persons born before January 1, 1957; except women who could become pregnant; or

7.1.10.2.2 Laboratory evidence of antibodies to rubella virus; or

7.1.10.2.3 A documented receipt from a physician or health facility that rubella vaccine was administered on or after 12 months of age.

7.1.10.3 Mumps immunity:

7.1.10.3.1 Persons born before January 1, 1957; or

7.1.10.3.2 Physician diagnosed history of mumps disease; or

7.1.10.3.3 Laboratory evidence of immunity; or

7.1.10.3.4 A documented receipt from a physician or health facility that mumps vaccine was administered on or after 12 months of age.

7.1.11 Immunization requirements pursuant to subsection 7.1.10 shall be waived for:

7.1.11.1 A student whose licensed physician certifies that such immunization may be detrimental to the student's health;

7.1.11.2 A student who presents a notarized document that immunization is against their religious beliefs.

7.1.12 The student health service, the admissions office, and the office of the university or college registrar are jointly responsible for implementing subsection 7.1.10 through notification of immunization requirements, the collection and verification of documented vaccine histories, identification and notification of students not in compliance, and imposition of sanctions for non-compliance.

7.1.13 Students who cannot show evidence of immunity to measles pursuant to subsection 7.1.10 and who cannot show documented receipt of ever having received measles vaccine shall be permitted to enroll on the condition that 2 doses be administered within 45 days or at the resolution of an existing medical contraindication. Students who cannot show evidence of immunity to rubella or mumps or who have had only 1 dose of measles vaccine shall be permitted to enroll on the condition that measles, mumps, and rubella immunizations be obtained within 14 days or at the resolution of an existing medical contraindication. However, in implementing these requirements, doses of a measles containing vaccine shall not be given closer than 28 days apart.

7.1.14 The Division Director may maintain a registry of the immunization status of persons vaccinated against any vaccine preventable diseases (hereafter called an "immunization registry").

7.1.14.1 Physicians and other health care providers who give immunizations shall report information about the immunization and the person to whom it was given for addition to the immunization registry in a manner prescribed by the Division Director or designee.

7.1.14.2 The Division Director or designee may disclose information from the immunization registry without a patient's, parent's, or guardian's written release authorizing such disclosure to the following:

7.1.14.2.1 The person immunized, or a parent or legal guardian of the person immunized, or persons delegated in writing by same.

7.1.14.2.2 Employees of public agencies or research institutions, however only when it can be shown that the intended use of the information is consistent with the purposes of Section 7.0 of this regulation.

7.1.14.2.3 Health records staff of school districts and child care facilities.

7.1.14.2.4 Persons who are other than public employees who are entrusted with the regular care of those under the care and custody of a state agency including but not limited to operators of day care facilities, group, residential care facilities and adoptive or foster parents.

7.1.14.2.5 Health insurers, however only when the person immunized is a client of the health insurer.

7.1.14.2.6 Health care professionals or their authorized employees who have been given responsibility for the care of the person immunized.

7.1.14.3 If any person authorized in subsection 7.1.14.2 discloses information from the immunization registry for any other purpose, it is an unauthorized release and such person may be subject to civil and criminal penalty.

7.2 Ophthalmia Neonatorum

7.2.1 Any physician, nurse, midwife, or other health care provider so permitted to under the law, who attends the birth of an infant in Delaware, shall provide or cause to be provided prophylactic treatment against inflammation of the eyes of the newborn.

7.2.2 Said prophylactic treatment shall be provided within 1 hour of birth and consist of:

7.2.2.1 1% silver nitrate in single dose containers;

7.2.2.2 A 1-2-centimeter ribbon of sterile ophthalmic ointment containing tetracycline (1%) or erythromycin (0.5%) in single-use tubes; or

7.2.2.3 Other treatment recommended for this purpose as published in the most recent edition of the U.S. Preventive Services Task Force, Guide to Clinical Preventive Services.

7.3 Sexually Transmitted Diseases (STDs)

7.3.1 Appendix I lists STDs regarded to cause significant morbidity and mortality, can be screened, diagnosed and treated, or are of major public health concerns such that surveillance of the disease occurrence is in the public interest, and therefore shall be designated as sexually transmitted and reportable pursuant to 16 Del.C. Ch. 7.

7.3.1.1 For the purposes of this section, a suspect is any person having positive or clinical findings of a STD or in whom epidemiologic evidence indicates a STD may exist; or is identified as a sexual contact of a STD case and is provided treatment for the STD on that basis.

7.3.2 Reporting STDs

7.3.2.1 A health care provider who diagnoses, suspects, or treats a reportable STD and every administrator of a health facility or prison in which there is a case of a reportable STD shall report such case to the Division of Public Health.

7.3.2.1.1 Reports provided under this regulation shall specify the infected person's name, address, date of birth, gender, race, and ethnicity as well as the date of onset, name and stage of disease, type and amount of treatment given and the name and address of the submitting licensed health care professional.

7.3.2.2 Any person who oversees a clinical or hospital laboratory, blood bank, mobile unit, or other facility in which a laboratory examination of any specimen derived from a human body yields microscopic, cultural, serological, or other evidence suggestive of a reportable STD shall notify the Division of Public Health.

7.3.2.2.1 Reports provided under this regulation shall specify the name, date of birth, race, ethnicity, gender, and address of the person from whom the specimen was obtained, laboratory findings, and the name and address of the physician and that of the processing clinical laboratory. Identifying and demographic information shall be required only if made known to the reporting laboratory or hospital in which the laboratory is part.

7.3.2.3 The manner and timing of reports required by subsection 7.3 shall be made in accordance with Section 2.0 of this regulation unless otherwise specified by this regulation.

7.3.2.4 All reports and notification made pursuant to this section are confidential and protected from release except under the provisions of 16 Del.C. §§710 and 711.

7.3.2.4.1 From information received from laboratory notifications, the Division of Public Health may contact attending physicians.

7.3.2.4.2 The Division of Public Health shall inform the attending physician, if the notification indicates the person has an attending physician, before contacting a person from whom a specimen was obtained. However, if delays resulting from informing the physician may enhance the spread of the STD, or otherwise endanger the health of either individuals or the public, the Division of Public Health may contact the person without first informing the attending physician.

7.3.2.5 Any person or facility required to report a STD under this section shall permit the Division of Public Health to examine records in order to evaluate compliance with this section.

7.4 Human Immunodeficiency Virus (HIV), Acquired Immunodeficiency Syndrome (AIDS)

7.4.1 HIV/AIDS is regarded to cause significant morbidity and mortality, can be screened, diagnosed and treated, and is of major public health concern, such that surveillance of the disease occurrence is in the public interest, and therefore shall be designated as reportable pursuant to 16 Del.C. Ch. 5. Under this provision the following shall be reported:

7.4.1.1 A diagnosis of HIV, according to the Centers for Disease Control and Prevention case definition of HIV.

7.4.1.2 A diagnosis of AIDS, according to the Centers for Disease Control and Prevention case definition of AIDS.

7.4.1.3 A positive confirmed result of any test approved and indicative of the presence of HIV.

7.4.1.4 All CD4 T-lymphocyte percentage and test results and all viral load detection test results (detectable and undetectable).

7.4.1.5 A perinatal exposure of a newborn to HIV.

7.4.2 Reporting of HIV/AIDS and perinatal exposure of newborns to HIV

7.4.2.1 A health care provider who diagnoses or treats HIV/AIDS and every administrator of a health care facility or prison in which there is an HIV/AIDS infected person or perinatal exposure to HIV shall report such information to the Division of Public Health. Reports provided under this subsection shall specify the infected person's name, address, date of birth, gender, mode of transmission, race and ethnicity as well as the date of HIV positive laboratory result, date of perinatal exposure, date of AIDS diagnosis and stage of disease, type and amount of treatment given and the name and address of the submitting health care provider.

7.4.2.2 Any person who oversees a clinical or hospital laboratory, blood bank, mobile unit, or other facility in which a laboratory examination of any specimen derived from a human body yields serological or other evidence of HIV/AIDS, including perinatal exposure to HIV, shall notify the Division of Public Health.

7.4.2.2.1 Reports provided under this subsection shall specify the name, date of birth, race, ethnicity, gender and address of the person from whom the specimen was obtained, laboratory findings, including all CD4 T-lymphocyte percentage test results, all viral load detection test results (detectable and undetectable), and all HIV nucleotide sequencing test results. The name and address of the health care provider and that of the processing clinical laboratory shall also be included.

7.4.2.2.2 Reports made based on an HIV test to detect antibodies shall only be made if confirmed with a Western Blot or other confirmatory test.

7.4.2.2.3 All facilities obtaining blood from human donors for the purpose of transfusion or manufacture of blood products shall report HIV/AIDS consistent with subsection 7.4.2.2.

7.4.2.2.4 Any laboratory that examines specimens, or reporting source finding evidence of HIV, shall permit the Division of Public Health to examine the records of said laboratory, facility, or office in order to evaluate compliance with Section 7.0 of this regulation.

7.4.2.3 Reports made based on perinatal HIV exposure shall be made regardless of confirmatory testing.

7.4.2.4 Reports of HIV/AIDS, required by subsection 7.4 shall be placed into the United States mail, using a special envelope that will be provided by the Division of Public Health, and routed to the Division within 48 hours of diagnosis, positive test, or treatment. Any other reporting method must be approved in advance and must be in a time frame acceptable to the Division.

7.4.2.5 As it is the intent of the Division of Public Health to continue the availability of anonymous HIV counseling and testing, and as it is not the practice to collect the name or other identifying information from a person who is anonymously tested for HIV, and therefore no name is available to be reported, nothing in this regulation shall preclude the performance of anonymous HIV testing.

7.4.3 Confidentiality of HIV/AIDS Reports

7.4.3.1 The Division of Public Health will evaluate reports of HIV/AIDS for completeness and potential referrals for service. All case reports will be kept in a confidential and in a secure setting.

7.4.3.2 The Division of Public Health will evaluate its procedures for HIV/AIDS named-based reporting on a continuous basis for timeliness, completeness of reporting, and security of confidential information.

7.4.3.3 The Division of Public Health will follow the December 10, 1999 Morbidity and Mortality Weekly Report Recommendations and Reports, "CDC Guidelines for National Human Immunodeficiency Virus Case Surveillance, Including Monitoring for Human Immunodeficiency Virus Infection and Acquired Immunodeficiency Syndrome" document as it pertains to patient records and confidentiality, or any subsequent revisions of said document.

7.4.3.4 All reports and notification made pursuant to Section 7.0 of this regulation are confidential and protected from release except under the provisions of 16 Del.C. §§710 and 711, §§1201 through 1204, and §§1201A through 1204A. Any person aggrieved by a violation of this section shall have a right of action in the Superior Court and may recover for each violation:

7.4.3.4.1 Against any person who negligently violates a provision of this regulation, damages of $1,000 or actual damages, whichever is greater.

7.4.3.4.2 Against any person who intentionally or recklessly violates a provision of subsection 7.4 of this regulation, damages of $5,000 or actual damages, whichever is greater.

7.4.3.4.3 Reasonable attorneys' fees.

7.4.3.4.4 Such other relief, including an injunction, as the court may deem appropriate.

7.4.3.4.5 Any action under this regulation is barred unless the action is commenced within 3 years after the cause of action accrues. A cause of action will accrue when the injured party becomes aware of an unauthorized disclosure.

7.4.3.5 From information received from reports of HIV infection, the Division of Public Health may contact attending physicians. The Division of Public Health shall inform the attending physician, if the notification indicates the person has an attending physician, before contacting a person on whom the report is made. However, if delays resulting from informing the physician may enhance the spread of HIV, or otherwise endanger the health of any individuals, the Division of Public Health may contact the person without first informing the attending physician.

7.4.4 Duty to Disclose the Identity of Sexual or Needle sharing Partners of HIV Infected Patients

7.4.4.1 Any health care provider diagnosing or caring for an HIV infected patient shall disclose the identity of the patient's sexual or needle-sharing partner or partners (if known), including spouses to the Division of Public Health so that the partner or partners may be notified of their risk of infection, provided that:

7.4.4.1.1 The provider knows of an identifiable partner at risk of infection who may not have been informed of their potential risk; and

7.4.4.1.2 The provider believes there is a significant risk of harm to the partner; and

7.4.4.1.3 Reasonable efforts have been made to counsel the patient pursuant to 16 Del.C. §1202(e), urging the patient to notify the partner, and the patient has refused or is unlikely to notify the partner.

7.4.4.2 Any health care provider diagnosing or caring for an HIV infected patient shall also report to the Division of Public Health relevant facts about a patient that does not pose a threat to an identifiable partner but, in the professional judgment of the provider based upon stated intended acts, the patient may threaten further spread of HIV to the general population. In this instance the conditions specified in subsection 7.4.4.1.3 shall apply. Disclosure shall be for the purpose of providing appropriate counseling to the patient.

7.4.4.3 Procedures for disclosing information pursuant to this section shall be specified by the Division.

7.5 Tuberculosis

7.5.1 Any person afflicted with or suspected of being afflicted with tuberculosis disease and in need of hospitalization and unable to pay the cost, shall be hospitalized at public expense wherever and whenever facilities are available and provided that private or third-party funds are not available for this purpose.

7.5.2 Reporting Tuberculosis

7.5.2.1 Physicians, pharmacists, nurses, hospital administrators, medical examiners, morticians, laboratory administrators, and other health care providers who provide health care services to a person with diagnosed, suspected, or treated tuberculosis (TB) shall report such a case to the Division of Public Health.

7.5.2.1.1 Reports provided under this subsection shall specify the infected person's name, address, date of birth, race, ethnicity, gender, date of onset, site of disease, prescribed anti-TB medications, and, in the case of laboratory administrators, the name and address of the submitting health professional.

7.5.2.1.2 A report shall be telephoned into the Division of Public Health within 2 working days of the provision of service or laboratory finding.

7.5.2.2 Any person who oversees a clinical or hospital laboratory or other facility in which a laboratory examination of sputa, gastric contents, or any other specimen derived from human body yields microscopic, cultural, serological, or other evidence suggestive of tubercle bacilli shall notify the Division of Public Health by telephone within 2 working days of the occurrence.

7.5.2.3 Any health care provider who has knowledge about a person with multiple drug-resistant tuberculosis (MDR-TB), even if the confirmed or suspected TB cases had been previously reported, shall report the occurrence to the Division of Public Health within 2 days of the occurrence.

7.5.2.4 Persons with TB who have demonstrated an inability or an unwillingness to adhere to a prescribed treatment regimen, who refuse medication, or who show other evidence of not taking anti-TB medications as prescribed, shall be reported to the Division of Public Health within 2 days of the occurrence.

7.5.3 Diagnostic Examinations

7.5.3.1 Any persons suspected of having infectious tuberculosis shall have a tuberculosis skin or blood test, a chest radiograph, laboratory examination of sputum, gastric contents or other body discharges as may be required by the Division Director or designee to determine whether said patient represents an infectious case of tuberculosis.

7.5.3.2 The Division Director or designee shall determine the names of household and other contacts who may be infected with tuberculosis and cause them to be examined for the presence of tuberculosis disease.

7.5.4 Clinical Management

7.5.4.1 In addition to fulfilling the reporting requirements of subsection 7.5.2, health care providers shall manage persons with active TB disease by following 1 of 3 courses of action:

7.5.4.1.1 They shall immediately refer the client to the Division of Public Health for comprehensive medical and case management services; or

7.5.4.1.2 They shall provide comprehensive assessment, treatment, and follow-up services (including patient education, directly observed therapy and contact investigation) to the client and the client’s contacts consistent with current American Thoracic Society and the Centers for Disease Control and Prevention (ATS/CDC) guidelines; or

7.5.4.1.3 They shall initiate appropriate medical treatment and refer the client to the Division of Public Health for coordination of community services and case management including directly observed therapy (DOT).

7.5.4.1.3.1 If the health care provider chooses subsection 7.5.4.1.2 or 7.5.4.1.3 above, then the Division Director or designee may ask the health care provider for information about the care and management of the patient, and the health care provider shall assure that the requested information is communicated.

7.5.4.2 Patients with infectious tuberculosis who are dangerous to public health may be required by the Division Director or designee to be hospitalized, isolated, or otherwise quarantined. Whenever facilities for adequate isolation and treatment of infectious cases are available in the home and patient will accept said isolation, it shall be left to the discretion of the Division Director or designee as to whether these or other facilities shall be used.

7.6 Healthcare-Associated Infections. By January 1, 2008, healthcare-associated infections shall be reported to the Centers for Disease Control and Prevention (CDC) through the National Healthcare Safety Network (NHSN) in accordance with the NHSN and the Department of Health and Social Service requirements and procedures as cited in 16 Del.C. Ch. 10A.

7.6.1 Definitions

For the purpose of Section 7.0 of this regulation, the following definitions shall apply:

"Agency for Healthcare Research and Quality” or “AHRQ" means an agency of the United States Department of Health and Human Services that works to improve the quality, safety, efficiency, and effectiveness of healthcare for all Americans and supports research that improves the quality of healthcare services.

“Centers for Medicaid and Medicare Services” or “CMS” means a branch of the United States Department of Health and Human Services that administers Medicare, Medicaid, and the Children’s Health Insurance Program. CMS utilizes a system of payment for operating costs of healthcare facilities based on prospectively set rates. Rulings set forth by CMS have included specifications for use of NHSN for reporting certain healthcare-associated infections and other quality indicators for the purposes of monitoring and improving patient safety and quality of care.

“Correctional facility” means any medical unit operated within any Department of Correction facility in this State.

“Department” means the Delaware Department of Health and Social Services.

“Dialysis center” means a facility approved to furnish outpatient dialysis services directly to End Stage Renal Disease (ESRD) patients. Outpatient dialysis centers include staff-assisted dialysis (dialysis performed by the staff of the facility). ESRD is the stage of renal impairment that appears irreversible and permanent and requires a regular course of dialysis or kidney transplantation to maintain life.

“Freestanding surgical center” or “FSSC” means a facility that operates exclusively for the purpose of providing surgical services to patients not requiring hospitalization. The term does not include (1) a facility that is licensed as part of a hospital; (2) a facility that provides services or accommodations for patients who stay overnight; or (3) a facility that is used as an office or clinic for the private practice of a physician, podiatrist, or dentist.

“Healthcare-associated infection” or “HAI” means a localized or systemic condition that results from adverse reaction to the presence of an infectious agent or agents or its toxins; and that was not present or incubating at the time of admission to the healthcare facility.

“Healthcare-Associated Infection Advisory Committee” means a group that is appointed by the Secretary of the Department that includes 1 infection control professional who has responsibility for infection control programs from each hospital or health care system in Delaware, 4 infectious disease physicians with expertise in infection control, 1 representative from the Delaware Healthcare Facilities Association, 1 representative of a freestanding surgical center, 1 representative of a dialysis center, 1 representative of a psychiatric facility, and 1 representative from the State Division of Public Health, and the Public Health Healthcare-Associated Infections Specialist responsible for collating and reporting data. The Secretary shall also appoint 8 other members of the Committee including representatives from direct care nursing staff, academic researchers, consumer organizations, health insurers, health maintenance organizations, organized labor, and purchasers of health insurance, such as employers.

"Healthcare-Associated Infection Specialist" means a position established by the Department within the Division of Public Health supporting the functions of 16 Del.C. Ch. 10A. The Healthcare-Associated Infection Specialist must have knowledge of the National Healthcare Safety Network system and skills to appropriately analyze healthcare-associated infection data.

"Healthcare facility" means a correctional facility, dialysis center, freestanding surgical center, hospital, long-term care facility, psychiatric facility, or other facility as defined by the Centers for Medicaid and Medicare Services or the CDC.

"Hospital" means an acute care healthcare facility licensed under 16 Del.C. Ch. 10A.

“Infection preventionist” or “IP” means a registered nurse, physician, epidemiologist, or medical technologist who helps to prevent healthcare-associated infections by isolating source or sources of infections and limiting their spread. The IP systematically collects, analyzes, and interprets health data in order to plan, implement, evaluate, and disseminate appropriate public health practices. The IP also trains healthcare staff through instruction and dissemination of information on infection control practices.

“Long-term acute care facility” or “LTAC” means a long-term care hospital as defined by CMS. CMS defines long-term care hospitals as having an average length of stay of 25 days or more among all patients. Licensed LTACs are denoted by having the last 4 digits of the facility CMS Certification Number (CCN) between 2000 and 2299.

“Long-term care facility” means an institution such as a nursing home, skilled nursing facility, or intermediate care facility that provides healthcare to people who are unable to manage independently in the community.

“National Healthcare Safety Network” or “NHSN” means an internet-based surveillance system that is confidential. It is managed by the Division of Healthcare Quality Promotion at the CDC and used for the monitoring events associated with health care. The NHSN provides facilities and states with data needed to identify problem areas, measure progress of prevention efforts, and work toward eliminating healthcare-associated infections. It is the conduit for healthcare facilities to comply with CMS infection reporting requirements.

"Psychiatric facility" means a facility that is primarily engaged in providing, by or under the supervision of a doctor of medicine or osteopathy, psychiatric services for the diagnosis and treatment of persons with mental illness.

“Public Report” means the report provided to healthcare facilities and the public by the Department as set forth in 16 Del.C. §1003A(b).

“Secretary” means the Secretary of the Delaware Department of Health and Social Services.

7.6.2 Membership in NHSN

7.6.2.1 All hospitals in the State shall join the NHSN or its successor.

7.6.2.2 All outpatient dialysis centers in the State shall join the NHSN or its successor in accordance with CMS reporting specifications.

7.6.2.3 All LTACs in the State shall join the NHSN or its successor in accordance with CMS reporting specifications.

7.6.2.3.1 Every licensed LTAC (denoted by having the last 4 digits of the facility CMS Certification Number (CCN) between 2000 and 2299) shall join the NHSN as an individual LTAC facility with a unique NHSN facility ID number.

7.6.2.3.2 If an independently licensed LTAC location currently resides within an acute care or critical access facility type within NHSN, that LTAC location must be removed from the hospital and enrolled in NHSN as a separate facility and identified as a “HOSP-LTAC” facility type.

7.6.2.4 With concurrence of the HAI Advisory Committee, the Department may require other healthcare facilities through regulation to join the NHSN as may be appropriate in accordance with 16 Del.C. Ch 10A.

7.6.3 Persons and Institutions Required to Report

7.6.3.1 A physician who diagnoses and treats a healthcare-associated infection related to a clinical procedure, or a licensed practitioner who is permitted by law to diagnose and treat such infection and does so, is required to report the infection back to the healthcare facility at which the clinical procedure was performed. The infection control department of the healthcare facility will then be required to report to the Department only those infections that meet the accepted NHSN definitions and are currently required to be reported by law.

7.6.3.2 Hospitals shall report data on healthcare-associated infections and authorize the Department to have access to hospital-specific data contained in the NHSN database consistent with the requirements of 16 Del.C. Ch. 10A. Hospital staff assigned to fulfill the obligations of reporting under this regulation shall be trained and shall follow the methods and procedures required by the NHSN as a condition of participation.

7.6.3.3 Correctional facilities shall report data on any healthcare-associated infections related to specific clinical procedures resulting from care in the correctional facility’s medical unit consistent with the requirements of 16 Del.C. Ch. 10A.

7.6.3.4 Outpatient dialysis centers shall report data on healthcare-associated infections related to specific clinical procedures resulting from care in the facility as determined by CMS or the CDC and authorize the Department to have access to outpatient dialysis center-specific data contained in the NHSN database consistent with the requirements of 16 Del.C. Ch. 10A. Outpatient dialysis center staff assigned to fulfill the obligations of reporting under this regulation shall be trained and shall follow the methods and procedures required by the NHSN as a condition of participation.

7.6.3.5 LTACs shall collect data on healthcare-associated infections related to specific clinical procedures resulting from care in the facility as determined by CMS or the CDC and authorize the Department to have access to LTAC-specific data contained in the NHSN database consistent with the requirements of 16 Del.C. Ch. 10A. LTAC staff assigned to fulfill the obligations of reporting under this regulation shall be trained and shall follow the methods and procedures required by the NHSN as a condition of participation.

7.6.3.6 Other healthcare facilities required to join the NHSN, as determined by the HAI Advisory Committee, shall authorize the Department to have access to healthcare facility-specific data contained in the NHSN database consistent with the requirements of 16 Del.C. Ch. 10A. Staff of other healthcare facilities required to join the NHSN as determined by the HAI Advisory Committee that are assigned to fulfill the obligations of reporting under this regulation shall be trained and shall follow the methods and procedures required by the NHSN as a condition of participation.

7.6.4 Reporting of Data

7.6.4.1 Healthcare-associated infections required to be reported to the Department shall consist of the same HAIs required to be reported to CMS. In carrying out this requirement hospitals shall comply with the Hospital Inpatient Prospective Payment System final rule as published by CMS in the Federal Register.

7.6.4.2 Hospitals and other healthcare facilities as specified in this regulation shall report healthcare-associated infections pursuant to subsection 7.6.4.1 to the NHSN except for correctional facilities.

7.6.4.3 Correctional facilities shall report healthcare-associated infections consistent with subsection 11.3 on communicable diseases of this regulation.

7.6.4.4 In making such reports, healthcare facilities shall abide by the reporting procedures required for NHSN participation, including the frequency of reports, the information to be reported, and other standards required by the NHSN.

7.6.5 Hospital reports

7.6.5.1 Individual hospitals shall report to the Department those healthcare-associated infections required by CMS to be reported.

7.6.5.2 Infection preventionists, or a designee, of hospitals shall submit quarterly reports on their healthcare-associated infection data to the Department using the accepted NHSN definitions. Prevention and control data related to quality measures will be based on nationally recognized and recommended standards that may include those developed by the CDC, CMS, or the AHRQ.

7.6.6 Correctional facility reports

7.6.6.1 Correctional facilities shall report data on any healthcare-associated infections related to specific clinical procedures resulting from care in the correctional facility's medical unit. These categories of infection data may differ from that information required from hospitals.

7.6.6.2 A designee of the correctional facility shall submit quarterly reports on their healthcare-associated infection data to the Department using the accepted CDC, NHSN, or Department definitions. Prevention and control data related to quality measures will be based on nationally recognized and recommended standards that may include those developed by the CDC, CMS, or the AHRQ. The information from the correctional facilities shall be segregated from the hospital data contained in the reports submitted pursuant to 16 Del.C. Ch. 10A.

7.6.7 Outpatient dialysis center reports

7.6.7.1 Individual outpatient dialysis centers shall report to the Department those healthcare-associated infections required by CMS to be reported.

7.6.7.2 Infection preventionists, or a designee, of outpatient dialysis centers shall submit quarterly reports on their healthcare-associated infection data to the Department using the accepted NHSN definitions. Prevention and control data related to quality measures will be based on nationally recognized and recommended standards that may include those developed by the CDC, CMS, or the AHRQ.

7.6.8 Other healthcare facility reports

7.6.8.1 Only with the concurrence of the HAI Advisory Committee, and not until such time that CMS or CDC issue final federal regulations requiring such, and after careful evaluation of the economic and public health impact, the Department may through regulation require the reporting of healthcare-associated infections from healthcare facilities other than hospitals, correctional facilities, LTACs, and outpatient dialysis centers.

7.6.8.2 The procedures for reporting shall be consistent with procedures for reporting by hospitals as specified in this chapter, except as may be necessary to accommodate the unique characteristics and capabilities of the healthcare facilities and the capabilities of the NHSN.

7.6.9 Quarterly Reports

7.6.9.1 The Department will collate and prepare healthcare-associated infection data reported in NHSN by healthcare facilities quarterly and make these quarterly reports publicly available.

7.6.9.2 Data in quarterly reports must cover a period ending not earlier than 45 days prior to submission of the report.

7.6.9.3 Quarterly reports shall be made available to each healthcare facility 45 days after submittal to the Department for review by the healthcare facilities.

7.6.9.4 The healthcare facilities shall have 7 days to review the quarterly reports and report any changes to the Department. Following the 7-day review period, such quarterly reports shall be made available to the public at each hospital and through the Department (the "Public Report").

7.6.9.5 If the healthcare facility is a hospital that is a division or subsidiary of another entity that owns or operates other hospitals or related organizations, the quarterly report shall be for the specific division of or subsidiary and not for the other entity.

7.6.9.6 After June 30, 2010, and upon consultation with the HAI Advisory Committee and other experts in infection, prevention, identification and control, the Department may revise categories of infections set forth in subsection 7.6.4.1.

7.6.10 Annual Department reports

7.6.10.1 The Department shall annually submit to the legislature a report summarizing the hospital quarterly reports and shall publish the annual report on its website. Following the initial report, the Department shall update the public information on a quarterly basis.

7.6.10.2 All reports issued by the Department shall be risk adjusted or use some other method to account for the differences in patient populations among hospitals.

7.6.10.3 The annual report shall compare healthcare-associated infection rates to national rates (i.e. the use of standardized infection ratios [SIRs]) published by the NHSN program and collected pursuant to this chapter for each individual hospital in the State. The Department, in consultation with the HAI Advisory Committee, shall make this report as easy to comprehend as possible. The report shall also include an executive summary, written in plain language that shall include a discussion of findings, conclusions, and trends concerning the overall state of healthcare-associated infections in the State, including a comparison to prior years. The report may include policy recommendations, as appropriate.

7.6.10.4 The Department shall publicize the report and its availability as widely as practical to interested parties, including hospitals, providers, media organizations, health insurers, health maintenance organizations, purchasers of health insurance, organized labor, consumer or patient advocacy groups and individual consumers. The annual report shall be made available to any person upon request.

7.6.10.5 No healthcare facility report or Department disclosure may contain information identifying a patient, employee, or licensed health care professional in connection with a specific infection incident, pursuant to 16 Del.C. Ch. 10A.

7.6.10.6 The annual report shall provide background information about each hospital, which shall include: the hospital's adult and pediatric populations, bed size, and specialty divisions, whether the hospital provides tertiary care, and whether the hospital is a teaching or nonteaching institution. This background information shall be included in the Public Report.

7.6.10.7 The annual report shall include a brief summary to allow hospitals to comment on performance improvement and changes in patient population and risk factors. The information contained in the summary report shall be considered proprietary information and shall be utilized by the Department but shall not be made available in the Public Report and shall not be subject to disclosure under the State's Freedom of Information Act [29 Del.C. Ch. 100].

7.6.11 Healthcare-Associated Infection Advisory Committee

7.6.11.1 The HAI Advisory Committee engages personnel with appropriate training or certification in infection prevention and control for the purposes of collecting data.

7.6.11.2 The HAI Advisory Committee shall assist the Department in the development of all aspects of the Department's methodology for collection, analyzing, and disclosing the information collected under 16 Del.C. Ch. 10A including collection methods, formatting, and methods and means for release and dissemination.

7.6.11.3 In developing the methodology for collecting and analyzing the infection rate data, the Department and the HAI Advisory Committee shall adopt the methodologies and system for data collection from the NHSN or its successor. The data collection and analysis methodology shall be disclosed to the public prior to any public disclosure of healthcare-associated infection rates.

7.6.11.4 The HAI Advisory Committee shall assist the Department in the sharing of information and best practices toward the development of activities and policies that:

7.6.11.4.1 Enhance coordination between healthcare facilities throughout the continuum of care for the prevention and control of healthcare-associated infections;

7.6.11.4.2 Promote the prevention and control of healthcare-associated infections generally; and

7.6.11.4.3 Encourage the creation of benchmarks against which to measure progress in the prevention and control of healthcare-associated infections.

7.6.12 Privacy. It is the express intent of the legislature that a patient's right of confidentiality shall not be violated in any manner. Patient Social Security numbers and any other information that could be used to identify an individual patient shall not be released notwithstanding any other provision of law.

7.6.13 Penalties

7.6.13.1 A determination that a healthcare facility has violated the provisions of this chapter may result in any of the following:

7.6.13.1.1 Termination of licensure or other sanctions relating to licensure under Chapter 10 of this title; or

7.6.13.1.2 A civil penalty of up to $500 per day per violation for each day the healthcare facility is in violation of 16 Del.C. Ch. 10A.

7.6.14 Regulatory oversight. The Department shall be responsible for ensuring compliance. When the Department licenses a healthcare facility according to the provisions of this title, compliance with this chapter shall be a condition of licensure.

7.6.15 Privilege and confidentiality protections. Notwithstanding any other provision of federal, state, or local law, the healthcare-associated infection data provided pursuant to this chapter is privileged and, except for §§1003A, 1004A and 1005A of 16 Del.C. Ch. 10A., shall not be:

7.6.15.1 Subject to admission as evidence or other disclosure in any federal, state, or local civil, criminal, or administrative proceeding; or

7.6.15.2 Subject to use in a disciplinary proceeding against a healthcare facility or provider; or

7.6.15.3 Subject to disclosure under 29 Del.C. Ch. 100.

**History**
- *9 DE Reg. 1188 (02/01/06)*
- *17 DE Reg. 320 (09/01/13)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *23 DE Reg. 665 (02/01/20)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *12 DE Reg. 1418 (05/01/09)*
- *15 DE Reg. 1163 (02/01/12)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *9 DE Reg. 1188 (02/01/06)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *12 DE Reg. 1418 (05/01/09)*
- *17 DE Reg. 320 (09/01/13)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *12 DE Reg. 1418 (05/01/09)*
- *15 DE Reg. 1163 (02/01/12)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*

##### **16 Del. Admin. Code § 4202-8.0** Preparation for Burial {#sec-4202-8.0 omnilex-key=us-de-regs-official--title-16--4202-8.0}

See 16 Del.C. Ch. 31 and Department of Health and Social Services regulations promulgated thereunder, 16 DE Admin. Code 4204 Care and Transportation of the Dead.

**History**
- *9 DE Reg. 1188 (02/01/06)*
- *17 DE Reg. 320 (09/01/13)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *23 DE Reg. 665 (02/01/20)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *12 DE Reg. 1418 (05/01/09)*
- *15 DE Reg. 1163 (02/01/12)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *9 DE Reg. 1188 (02/01/06)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *12 DE Reg. 1418 (05/01/09)*
- *17 DE Reg. 320 (09/01/13)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *12 DE Reg. 1418 (05/01/09)*
- *15 DE Reg. 1163 (02/01/12)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*

##### **16 Del. Admin. Code § 4202-9.0** Disposal of Infectious Articles, Remains {#sec-4202-9.0 omnilex-key=us-de-regs-official--title-16--4202-9.0}

No person shall dispose of articles, or human or animal remains known or suspected to be capable of infecting others with a communicable disease in such a manner whereby exposure to such infectious agents may occur. See also 16 DE Admin. Code 4204 Care and Transportation of the Dead, Section 10.0 ("Disposition of Amputated Parts of Human Bodies").

**History**
- *9 DE Reg. 1188 (02/01/06)*
- *17 DE Reg. 320 (09/01/13)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *23 DE Reg. 665 (02/01/20)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *12 DE Reg. 1418 (05/01/09)*
- *15 DE Reg. 1163 (02/01/12)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *9 DE Reg. 1188 (02/01/06)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *12 DE Reg. 1418 (05/01/09)*
- *17 DE Reg. 320 (09/01/13)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *12 DE Reg. 1418 (05/01/09)*
- *15 DE Reg. 1163 (02/01/12)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*

##### **16 Del. Admin. Code § 4202-10.0** Diseased Animals {#sec-4202-10.0 omnilex-key=us-de-regs-official--title-16--4202-10.0}

10.1 Importation and Sale. No person shall bring into this state or offer for sale domestic or wild animals infected or suspected to be infected with a disease communicable from animals to man.

10.2 Notification. It shall be the duty of persons having custody of care of animals infected or suspected to be infected with a disease transmitted from animals to man to notify the Division Director or designee of the infection.

**History**
- *9 DE Reg. 1188 (02/01/06)*
- *17 DE Reg. 320 (09/01/13)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *23 DE Reg. 665 (02/01/20)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *12 DE Reg. 1418 (05/01/09)*
- *15 DE Reg. 1163 (02/01/12)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *9 DE Reg. 1188 (02/01/06)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *12 DE Reg. 1418 (05/01/09)*
- *17 DE Reg. 320 (09/01/13)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *12 DE Reg. 1418 (05/01/09)*
- *15 DE Reg. 1163 (02/01/12)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*

##### **16 Del. Admin. Code § 4202-11.0** Notification of Emergency Medical Care Providers of Exposure to Communicable Diseases {#sec-4202-11.0 omnilex-key=us-de-regs-official--title-16--4202-11.0}

11.1 For the purposes of Section 11.0 of this regulation, the following definitions shall apply.

"Emergency medical care provider" means a fire fighter, law enforcement officer, paramedic, emergency medical technician, correctional officer, ambulance attendant, or other person who serves as employee or volunteer of an ambulance service or provides prehospital emergency medical service.

"Receiving medical facility" means a hospital or similar facility that receives a patient attended by an emergency medical care provider for the purposes of continued medical care.

"Standard precautions" means those precautions, including the appropriate use of hand washing, protective barriers, and care in the use and disposal of needles and other sharp instruments, that minimize the risk of transmission of communicable diseases between patients and health care providers. Standard precautions require that all care providers use appropriate barrier precautions to prevent exposure to blood and body fluids, secretions, and excretions of all patients at all times.

11.2 Standard Precautions

11.2.1 Didactic Instruction. Education and training with respect to standard precautions shall be a mandatory component of any required training and any required continuing education for all emergency medical care providers who have patient contact. Training shall be appropriately tailored to the needs and educational background of the emergency medical care providers being trained. Training shall include the following:

11.2.1.1 Mechanisms and routes of transmission of viral, bacterial, rickettsial, fungal, and mycoplasmal human pathogens.

11.2.1.2 Proper techniques of hand washing, including the theory supporting the effectiveness of hand washing, and guidelines for waterless hand cleansing in the field.

11.2.1.3 Proper techniques and circumstances under which barrier methods of protection (personal protective equipment) from contamination by microbial pathogens are to be implemented. The instruction is to include the theory supporting the benefits of these techniques.

11.2.1.4 Proper techniques of disinfection and cleanup of spills of infectious material. This instruction is to include the use of absorbent, liquid, and chemical disinfectants.

11.2.1.5 Instruction regarding the reporting and documentation of exposures to infectious agents and the requirement for employers to have an exposure control plan.

11.2.1.6 Proper disposal of contaminated needles and other sharps. The instruction is to include information about recapping needles and using puncture-resistant, leak-resistant containers, and safety sharps.

11.2.1.7 First aid and immediate care of wounds that may be incurred by an emergency medical care provider.

11.2.2 Practical or Laboratory Instruction

11.2.2.1 Practical sessions addressing the field application of the above didactic instruction must be part of the curriculum.

11.2.2.2 The practical sessions shall provide a means of hands-on experience and training in the following:

11.2.2.2.1 The proper use of personal protective equipment, hand-washing disinfection, cleanup of infectious spills, handling and disposal of contaminated sharps, and the proper completion of reporting forms.

11.2.3 Approval of Curricula. Any provider of mandatory education and training and continuing education pursuant to this section must submit a curriculum for approval by the Division of Public Health and shall not utilize curricula that are not regarded by the Division of Public Health to be in substantial compliance with subsections 11.2.1 and 11.2.2.

11.3 Communicable Diseases

11.3.1 Communicable Disease Defined. For the purposes of Section 11.0 only, exposure to patients infected with the following communicable disease agents shall warrant notification to an emergency medical care provider pursuant to this section:

11.3.1.1 Human Immunodeficiency Virus (HIV)

11.3.1.2 Hepatitis B Virus

11.3.1.3 Hepatitis C Virus

11.3.1.4 Meningococcal disease

11.3.1.5 Haemophilus influenzae

11.3.1.6 Measles

11.3.1.7 Tuberculosis

11.3.1.8 Uncommon or rare pathogens

11.3.2 Infection Defined. For the purposes of Section 11.0 only, a patient shall be considered infected with a communicable disease when the following conditions are satisfied:

11.3.2.1 Blood-borne pathogens

11.3.2.1.1 HIV: ELISA and western blot (or other confirmatory test accepted by prevailing medical opinion) tests must be positive.

11.3.2.1.2 Hepatitis B: Positive for Hepatitis B surface antigen.

11.3.2.1.3 Hepatitis C: Hepatitis C antibody screening test and more specific supplemental test positive.

11.3.2.2 Airborne and droplet-spread pathogens

11.3.2.2.1 Meningococcal disease: Compatible clinical findings and laboratory confirmation through isolation of Neisseria meningitidis from a normally sterile site.

11.3.2.2.2 Haemophilus influenzae: Compatible clinical findings of epiglottitis or meningitis and laboratory confirmation through isolation of Haemophilus influenzae from a normally sterile site or from the epiglottis.

11.3.2.2.3 Measles: Compatible clinical findings with or without laboratory confirmation by 1 of the following methods:

11.3.2.2.3.1 Presence of the measles virus from a clinical specimen;

11.3.2.2.3.2 Four-fold rise in measles antibody level by any standard serologic assay; or

11.3.2.2.3.3 Positive serologic test for measles IgM antibody.

11.3.2.2.4 Tuberculosis: Compatible clinical findings of pulmonary disease and identification of either acid-fast bacilli in sputum or the pathogen by culture.

11.3.2.3 Uncommon or rare pathogens. Infection with uncommon or rare pathogens determined by the Division of Public Health on a case-by-case basis.

11.3.3 Exposure Defined

11.3.3.1 Blood-borne pathogens. Exposure of an emergency medical care provider to a patient infected with a blood-borne pathogen as defined in subsection 11.3.2.1 shall include a needle-stick or other penetrating injury with an item contaminated by a patient's blood, plasma, pleural fluid, peritoneal fluid, tissue, cerebrospinal fluid, synovial fluid, peritoneal fluid, pericardial fluid, amniotic fluid, or any other body fluid or drainage that contains blood or plasma. Contact of these fluids with mucous membranes or non-intact skin of the emergency medical care provider or extensive contact with intact skin shall also constitute exposure.

11.3.3.2 Airborne and droplet-spread pathogens. Exposure of an emergency medical care provider to a patient infected with an airborne or droplet-spread pathogen as defined in subsection 11.3.2.2 shall be as follows:

11.3.3.2.1 Meningococcal disease and Haemophilus influenza: Close contact with an infected patient's oral secretions or sharing the same air space with an infected patient for 1 hour or longer without the use of an effective barrier such as a mask.

11.3.3.2.2 Measles: Sharing confined air space with an infected patient, regardless of contact time.

11.3.3.2.3 Tuberculosis: Sharing confined air space with an infected patient, regardless of contact time.

11.3.3.3 Uncommon or rare pathogens. The Division of Public Health shall determine definition of exposure to an uncommon or rare pathogen on a case-by-case basis.

11.3.3.4 Ruling on infection and exposure. When requested by the emergency medical care provider or receiving medical facility, the Division of Public Health shall investigate and issue judgment on any differences of opinion regarding infection and exposure as otherwise defined in subsection 11.3.

11.4 Request for Notification

11.4.1 Every employer of an emergency medical care provider and every organization which supervises volunteer emergency medical care providers must register the name or names of a designated officer who shall perform the following duties. The designated officer shall delegate these duties as may be necessary to ensure compliance with this regulation.

11.4.1.1 Receive requests for notification from emergency medical care providers;

11.4.1.2 Collect facts relating to the circumstances under which the emergency medical care provider may have been exposed;

11.4.1.3 Forward requests for notification to receiving medical facilities;

11.4.1.4 Report to the emergency medical care provider findings provided by the receiving medical facility; and

11.4.1.5 Assist the emergency medical care provider to take medically appropriate action if necessary.

11.4.2 Receiving medical facilities must register with the Division of Public Health the name or office to whom notification requests should be sent by an emergency medical care provider and who is responsible for ensuring compliance with this section.

11.4.3 If an emergency medical care provider desires to be notified under this regulation, the officer designated pursuant to subsection 11.4.1 shall notify the receiving medical facility within 24 hours after the patient is admitted to or treated by the facility on a form that is prescribed or approved by the State Board of Health.

11.5 Notification of Exposure to Airborne and Droplet-Spread Pathogens

11.5.1 Notwithstanding any requirement of subsection 11.4.3, a receiving medical facility must make notification when an emergency medical care provider has been exposed to an airborne or droplet-spread communicable disease pursuant to subsections 11.3.2.2 and 11.3.3.2. Such notification shall occur as soon as possible but not more than 48 hours after the exposure has been determined and shall apply to any patient upon whom such a determination has been made within 30 days after the patient is admitted to or treated by the receiving medical facility.

11.5.2 To determine if notification is necessary pursuant to this section, a receiving medical facility must review medical records of a patient infected with an airborne or droplet-spread communicable disease to determine if care was provided by an emergency medical care provider. If medical records do not so indicate, the receiving medical facility shall assume that no notification is required.

11.6 Notification of Exposure when Requested

11.6.1 When a request for notification has been made pursuant to subsection 11.4.3, the receiving medical facility shall attempt to determine if the patient is infected with a communicable disease and if the emergency medical care provider has or has not been exposed. Information provided on the request for notification and medical records and findings in possession of the receiving medical facility shall be used to make this determination. If a determination is made within 30 days after the patient is admitted to or treated by the receiving medical facility, the receiving medical facility shall notify the officer designated pursuant to subsection 11.4.1 as soon as possible but not more than 48 hours after the determination. The following information shall be provided in the notification:

11.6.1.1 The date that the patient was attended by the emergency medical care provider;

11.6.1.2 Whether or not the emergency medical care provider was exposed; and

11.6.1.3 If the emergency medical care provider was exposed, the communicable disease involved.

11.6.2 If, after expiration of the 30-day period and because of insufficient information, the receiving medical facility has not determined that the emergency medical care provider has or has not been exposed to a communicable disease, the receiving medical care facility shall so notify the officer designated pursuant to subsection 11.4.1 as soon as possible but not more than 48 hours after expiration of the 30-day period. The following information shall be provided in the notification:

11.6.2.1 The date that the patient was attended by the emergency medical care provider; and

11.6.2.2 That there is insufficient information to determine if an exposure has occurred.

11.6.3 The receiving medical facility shall provide to the Division of Public Health a copy of each form completed pursuant to subsection 11.4 which shall include information about whether or not the patient is infected, and if the emergency medical care provider is considered by the receiving medical facility to have been exposed.

11.7 Manner of Notification

11.7.1 A receiving medical facility must make a good faith effort, which is reasonably calculated based upon the health risks, the need to maintain confidentiality, and the urgency of intervention associated with the exposure, to expeditiously notify the officer designated pursuant to subsection 11.4.1.

11.7.2 If notification is by mail, and if, in the judgment of the receiving medical facility the circumstances warrant, the receiving medical facility shall ensure by telephone or other appropriate means that the designated officer of the emergency medical care provider has received notification.

11.8 Transfer of Patients

11.8.1 If, within the 30-day limitation defined in subsections 11.5.1 and 11.6.1 a patient is transferred from a receiving medical facility to a second receiving medical facility, the receiving medical facility must provide the second facility with all requests for notification made by emergency medical care providers for that patient.

11.8.2 The second receiving medical facility must make notification to the officer designated pursuant to subsection 11.4.1 if the facility determines within the remaining part of the 30-day period that the patient is infected and shall otherwise comply with this regulation.

11.9 Death of Patient

11.9.1 If, within the 30-day limitation defined in subsections 11.5.1 and 11.6.1, a patient is transferred from a receiving medical facility to a medical examiner, the receiving medical facility must provide the medical examiner with all requests for notification made by emergency medical care providers for that patient.

11.9.2 The medical examiner must make notification to the designated officer if the medical examiner determines that the patient is infected with a communicable disease and shall otherwise comply with this regulation.

11.10 Testing of Patients for Infection. Nothing in this regulation shall be construed to authorize or require a medical test of an emergency medical care provider or patient for any infectious disease.

11.11 Confidentiality. All requests and notifications made pursuant to this regulation shall be used solely for the purposes of complying with this regulation and are otherwise confidential.

APPENDIX I

State of Delaware - List of Reportable Diseases/Conditions

AIDS / HIV Stage III (S)

Acute flaccid myelitis

Alpha gal syndrome

Amebiasis

Anaplasmosis

Anthrax (T)

Arboviral human infections:

Anaplasmosis

Cache Valley virus disease

California encephalitis virus disease

California serogroup virus diseases

Chikungunya virus disease

Colorado tick fever virus disease

Eastern equine encephalitis virus disease

Jamestown Canyon virus disease

Japanese encephalitis virus disease

Keystone virus disease

La Crosse virus disease

Powassan virus disease

Snowshoe hare virus disease

St. Louis encephalitis virus disease

Tick-borne encephalitis viruses

Trivittatus virus disease

West Nile virus disease

Western equine encephalitis virus disease

Venezuelan equine encephalitis virus

Zika virus disease

Other Arboviral diseases, not otherwise specified

Babesiosis

Botulism (T)

Brucellosis (T)

Campylobacteriosis

Candida auris

Carbapenemase-Producing Organisms (CPO)

Carbon monoxide poisoning

Chancroid (S)

Chickenpox (Varicella)

Chlamydia (S)

Cholera (toxigenic Vibrio cholerae 01 or 0139) (T)

Coccidioidomycosis

Coronavirus, novel (novel coronavirus causing severe acute respiratory disease including the 2019 novel coronavirus disease [COVID-19], severe acute respiratory syndrome-associated coronavirus disease [SARS-CoV], and Middle East Respiratory Syndrome [MERS-CoV]) (T)

Creutzfeldt-Jakob Disease (T)

Cronobacter infection

Cryptosporidiosis

Cyclosporiasis

Cytomegalovirus (neonatal only)

Dengue virus infections (T)

Diphtheria (T)

Ehrlichiosis

Encephalitis

Enterobacteriaceae, carbapenem-resistant (invasive or urine only) (A)

Escherichia coli, Shigatoxin producing (STEC) (T)

ESBL B-lactamases-invasive only (A)

Foodborne Disease Outbreak (T)

Free living amebae infections

Giardiasis

Glanders (T)

Gonorrhea (S)

Granuloma inguinale (S)

Guillain-Barre

Haemophilus influenzae, invasive

Hansen's Disease (Leprosy)

Hantavirus (T)

Hemolytic Uremic Syndrome (T)

Hepatitis A (T)

Hepatitis B

Hepatitis C

Hepatitis Other

Herpes, congenital (S)

Herpes, genital (S)

Histoplasmosis

HIV (S)

Human Papillomavirus (S)

Influenza

Influenza-associated pediatric mortality (T)

Kawasaki Syndrome

Lead, child blood, all test results

Legionellosis

Leptospirosis

Listeriosis

Lyme Disease

Lymphogranuloma venereum (S)

Malaria

Measles (T)

Melioidosis

Meningitis, Aseptic

Meningitis, Bacterial other

Meningococcal disease (Neisseria meningitidis) (T)

Mpox virus infection (T)

Mumps (T)

Norovirus

Nosocomial (Healthcare-Associated) Disease Outbreak (T)

Pelvic Inflammatory Disease (N. gonorrhoeae, C. trachomatis, or unspecified) (S)

Pertussis (T)

Plague (T)

Poliomyelitis (T)

Psittacosis

Q Fever

Rabies (human and animal) (T)

Respiratory Syncytial virus-associated deaths (RSV)

Reye Syndrome

Rheumatic Fever

Ricin Toxin (T)

Rickettsial Disease

Rubella (including congenital, which is rapidly reportable [T])

Salmonellosis

Shigellosis

Silicosis

Smallpox (T)

Spotted fever rickettsiosis

Staphylococcal aureus, Vancomycin Intermediate or Resistant (VISA, VRSA) (T)

Staphylococcal Enterotoxin (T)

Streptococcal Disease, invasive

Streptococcus pneumoniae, invasive (A)

Syphilis, all stages (S)

Tetanus (T)

Toxic Shock Syndrome (Streptococcal or Staphylococcal)

Toxoplasmosis

Trichinellosis

Tuberculosis (T)

Tularemia (T)

Typhoid Fever (T)

Typhus Fever (endemic flea borne, louse borne, tick borne)

Vaccine Adverse Reaction

Vancomycin resistant Enterococcus, invasive only

Vibrio, non-cholera

Viral Hemorrhagic Fevers (T)

Waterborne Disease Outbreaks (T)

Yellow Fever (T)

Yersiniosis

2. Reporting timeframe

(T) - call or email within 4 hours

(S) - sexually transmitted disease, report required within 24 hours

(A) - Drug-Resistant Organisms required to be reported within 48 hours

All others - report required within 48 hours

APPENDIX II

Organisms and Samples to be sent to the Delaware Public Health Laboratory

1. All laboratories located in Delaware and laboratories that have specimen collection sites in Delaware, including those laboratories with testing or processing facilities located out of state, are required to submit suspected and confirmed isolates and clinical materials of proposed agents from Delaware residents to the DPHL.

2. All clinical or hospital laboratories, or other facilities, located in Delaware that presumptively identify or are unable to rule out biothreat organisms shall notify immediately and send an isolate, clinical material, or specimen to the DPHL for testing as soon as possible. Those located outside the State, should contact their nearest State Laboratory or Laboratory Response Network laboratory.

3. All other isolates and clinical specimens of microorganism listed in item 4. below shall be sent to the DPHL.

4. List of microorganisms to send to the DPHL:

4.1 Select Agent organisms (notify DPHL immediately, by secure email or telephone, prior to sending for confirmation within 24 hours of suspicion of clinical presentation for the following agents:

Bacillus anthracis/Bacillus cereus biovar anthracis

Brucella species

Burkholderia mallei

Burkholderia pseudomallei

Clostridium botulinum

Coxiella burnetii

Francisella tularensis

Ebola and other viral hemorrhagic viruses

Middle Eastern Respiratory Syndrome coronavirus (MERS-CoV)

Mpox virus

SARS-Coronavirus (CoV)/SARS-CoV-2 Chimeric viruses

Vaccinia virus

Variola (smallpox) virus

Yersinia pestis

4.2 Emerging Infectious Organisms of Public Health Concern - (notify DPHL immediately, by secure email or telephone, prior to sending for confirmation within 24 hours of suspicion of clinical presentation for the following agents:

Measles and Mumps virus

Mycobacterium tuberculosis complex

Haemophilus influenzae and Neisseria meningitidis from sterile body sites

Any agent suspected of displaying cluster/outbreak potential

Any individual cases displaying unusual patterns of antimicrobial resistance (including non-susceptibility to all tested antimicrobials), atypical virulence/resistance genetic mechanisms, or emerging infectious pathogen or pathogens.

4.3 Surveillance (Foodborne/Respiratory) (send within 3 - 5 business days, prior notification to lab not required)

Campylobacter species (minimum 2 samples per month per submitter)

Cronobacter species

COVID-19 (minimum 2 samples per week per submitter)

Influenza (minimum 2 samples per day per submitter during outbreak season)

Listeria monocytogenes

Norovirus (2 samples per month per submitter)

Salmonella species

Shiga toxin producing Escherichia coli (STEC)

Shigella species

Vibrio species

Yersinia enterocolitica

4.4 Antimicrobial resistance (send within 3 - 5 business days, prior notification of lab not required).

Candida auris

Neisseria gonorrhoeae, (cases suspected of antimicrobial resistance/treatment failure)

Staphylococcus aureus, Vancomycin resistant (VRSA)

Carbapenem resistant organisms (CRO) including Enterobacteriaceae (CRE) Acineto-bacter baumannii (CRAB), and Pseudomonas aeruginosa (CRPA)

5. Any environmental sample deemed as credible threats for harboring a toxin or a biological agent of terrorism shall be sent to the DPHL for testing immediately upon identification. Organizations must notify DPHL, by secure email/phone, prior to submitting for testing.

6. Clinical specimens from patients potentially exposed to a chemical agent of terrorism shall be sent to the DPHL for testing immediately upon identification.

**History**
- *9 DE Reg. 1188 (02/01/06)*
- *17 DE Reg. 320 (09/01/13)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *23 DE Reg. 665 (02/01/20)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *12 DE Reg. 1418 (05/01/09)*
- *15 DE Reg. 1163 (02/01/12)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *9 DE Reg. 1188 (02/01/06)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *12 DE Reg. 1418 (05/01/09)*
- *17 DE Reg. 320 (09/01/13)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*
- *9 DE Reg. 1188 (02/01/06)*
- *12 DE Reg. 1418 (05/01/09)*
- *15 DE Reg. 1163 (02/01/12)*
- *17 DE Reg. 320 (09/01/13)*
- *22 DE Reg. 1012 (06/01/19)*
- *23 DE Reg. 665 (02/01/20)*
- *24 DE Reg. 791 (02/01/21)*
- *27 DE Reg. 863 (05/01/24)*

#### **4203** Cancer Treatment Program

##### **16 Del. Admin. Code § 4203-1.0** Purpose {#sec-4203-1.0 omnilex-key=us-de-regs-official--title-16--4203-1.0}

1.1 The Cancer Treatment Program (CTP) is a program of Delaware Health and Social Services (DHSS), Division of Public Health (DPH) intended to provide medical insurance coverage to uninsured Delawareans for the treatment of cancer.

1.2 Definition of “uninsured” for purposes of this regulation - a person who meets all technical, financial, and residency requirements of this regulation.

**History**
- *8 DE Reg 1144 (2/1/05)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *8 DE Reg 1144 (2/1/05)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *11 DE Reg 680 (11/01/07)*
- *18 DE Reg. 67 (07/01/14)*
- *11 DE Reg 680 (11/01/07)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *8 DE Reg. 107 (7/1/04)*
- *18 DE Reg. 67 (07/01/14)*

##### **16 Del. Admin. Code § 4203-2.0** Availability Of Funds {#sec-4203-2.0 omnilex-key=us-de-regs-official--title-16--4203-2.0}

2.1 Benefits will be available to enrollees provided that funds for this program are made available to DHSS.

2.2 In the event that funds are not available, DHSS will notify enrollees and providers.

**History**
- *8 DE Reg 1144 (2/1/05)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *8 DE Reg 1144 (2/1/05)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *11 DE Reg 680 (11/01/07)*
- *18 DE Reg. 67 (07/01/14)*
- *11 DE Reg 680 (11/01/07)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *8 DE Reg. 107 (7/1/04)*
- *18 DE Reg. 67 (07/01/14)*

##### **16 Del. Admin. Code § 4203-3.0** General Application Information {#sec-4203-3.0 omnilex-key=us-de-regs-official--title-16--4203-3.0}

3.1 The application must be made in writing on the prescribed CTP form. An individual, agency, institution, guardian or other individual acting on behalf of the applicant can make this request for assistance for the applicant with his knowledge and consent. The CTP will consider an application without regard to race, color, age, sex, marital status, creed, sexual orientation, gender identity, disability, religion, national origin or political belief as per State and Federal law.

3.2 Each individual applying for the CTP is required to furnish his or her Social Security Number, if the individual has a Social Security Number.

3.3 Filing an application gives the applicant the right to receive a written determination of eligibility and the right to appeal the written determination.

**History**
- *8 DE Reg 1144 (2/1/05)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *8 DE Reg 1144 (2/1/05)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *11 DE Reg 680 (11/01/07)*
- *18 DE Reg. 67 (07/01/14)*
- *11 DE Reg 680 (11/01/07)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *8 DE Reg. 107 (7/1/04)*
- *18 DE Reg. 67 (07/01/14)*

##### **16 Del. Admin. Code § 4203-4.0** Technical Eligibility {#sec-4203-4.0 omnilex-key=us-de-regs-official--title-16--4203-4.0}

4.1 The following for an adult applicant are required to receive benefits under this program. The adult applicant must:

4.1.1 Need treatment for cancer in the opinion of the applicant’s licensed physician of record. Cancer treatment will not include routine monitoring for pre-cancerous conditions, or monitoring for recurrence during or after remission.

4.1.2 Be a Delaware resident.

4.1.3 Have been a Delaware resident at the time cancer was diagnosed.

4.1.4 Have no health insurance.

4.1.4.1 Examples of health insurance include comprehensive, major medical and catastrophic plans, Veterans Affairs Medical Services, Correctional Healthcare Services, Medicare, and Medicaid.

4.1.4.2 Excepted are the following types of insurance plans, which do not exclude eligibility for the CTP: dental, vision, dismemberment, drug, mental health, nursing home, blood bank, workman’s compensation, accident, family planning, the Delaware Prescription Assistance Program, the Delaware Chronic Renal Disease program, and non-citizen medical coverage.

4.1.4.3 The CTP is the payer of last resort and will only provide benefits to the extent that they are not covered by the plans listed in 4.1.4.2.

4.1.5 Meet one of the exemptions listed in the Patient Protection and Affordable Care Act's (PPACA) requirements to buy coverage.

4.1.5.1 Exemptions listed in the PPACA include: applicant is part of a religion opposed to acceptance of benefits from a health insurance policy; applicant is an undocumented immigrant; applicant is incarcerated; applicant is a member of an Indian tribe; applicant’s family income is below the threshold for filing a tax return; applicant is required to pay more than 8% of household income for health insurance, after taking into account any employer contributions or tax credits.

4.1.5.2 Applicants will need to show proof of exemption from the PPACA.

4.1.6 Be ineligible for Medicaid.

4.1.7 Be over the age of 18 years.

4.1.8 Be diagnosed with any cancer on or after July 1, 2004, or be receiving benefits for the diagnosis of colorectal cancer through the Division of Public Health’s Screening for Life program on June 30, 2004.

4.2 The following are required for a minor (child under 18 years of age) to receive benefits under this program. The minor applicant must:

4.2.1 Need treatment for cancer in the opinion of the applicant’s licensed physician of record. Cancer treatment will not include routine monitoring for pre-cancerous conditions, or monitoring for recurrence during or after remission.

4.2.2 Be a Delaware resident

4.2.3 Have been a Delaware resident at the time cancer was diagnosed.

4.2.4 Be diagnosed with any cancer on or after July 1, 2004.

4.2.5 The CTP is payer of last resort and will only provide benefits to the extent that they are not covered by other plans.

4.3 An inmate of a public institution shall be ineligible for the CTP.

4.3.1 For the purposes of the CTP, the definitions of public institution and inmate shall be the same as used by the Delaware Medicaid program 16 DE Admin. Code 14120.

4.4 The Medical Assistance Card is the instrument used to verify an individual’s eligibility for benefits. Prior to rendering services, medical providers are required to verify client eligibility using the client’s identification number by accessing one of the Electronic Verification Systems (EVS) options. Instructions for accessing EVS are described in the EVS section of the billing manual.

**History**
- *8 DE Reg 1144 (2/1/05)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *8 DE Reg 1144 (2/1/05)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *11 DE Reg 680 (11/01/07)*
- *18 DE Reg. 67 (07/01/14)*
- *11 DE Reg 680 (11/01/07)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *8 DE Reg. 107 (7/1/04)*
- *18 DE Reg. 67 (07/01/14)*

##### **16 Del. Admin. Code § 4203-5.0** Financial Eligibility {#sec-4203-5.0 omnilex-key=us-de-regs-official--title-16--4203-5.0}

5.1 To be eligible for the CTP the applicant must have countable household income that is less than 650% of the Federal Poverty Level (FPL).

5.2 Income is any type of money payment that is of gain or benefit to an individual. Income is either counted or excluded for the eligibility determination.

5.3 Countable income includes but is not limited to:

5.3.1 Social Security benefits – as paid after deduction for Medicare premium

5.3.2 Pension – as paid

5.3.3 Veterans Administration Pension – as paid

5.3.4 U.S. Railroad Retirement Benefits – as paid

5.3.5 Wages – gross amount before deductions for taxes and FICA

5.3.6 Senior Community Service Employment – gross amount before deductions for taxes and FICA

5.3.7 Interest/Dividends – gross amount

5.3.8 Capital Gains – gross amount from capital gains on stocks, mutual funds, bonds.

5.3.9 Credit Life or Credit Disability Insurance Payments – as paid

5.3.10 Alimony – as paid

5.3.11 Rental Income from entire dwelling – gross rent paid minus standard deduction of 20% for expenses

5.3.12 Roomer/Boarder Income – gross room/board paid minus standard deduction of 10% for expenses

5.3.13 Self Employment – countable income as reported to Internal Revenue Service (IRS)

5.3.14 Unemployment Compensation - gross amount before deductions for taxes and FICA

5.4 Excluded income includes but is not limited to:

5.4.1 Annuity payments

5.4.2 Individual Retirement Account (IRA) distributions

5.4.3 Payments from reverse mortgages

5.4.4 Capital gains from the sale of principal place of residence

5.4.5 Conversion or sale of a resource (i.e. cashing a certificate of deposit)

5.4.6 Income tax refunds

5.4.7 Earned Income Tax Credit (EITC)

5.4.8 Vendor payments (bills paid directly to a third party on behalf of the individual)

5.4.9 Government rent/housing subsidy paid directly to individual (i.e. HUD utility allowance)

5.4.10 Loan payments received by individual

5.4.11 Proceeds of a loan

5.4.12 Foster care payments made on behalf of foster children living in the home

5.4.13 Retired Senior Volunteer Program (RSVP)

5.4.14 Veterans Administration Aid and Attendance payments

5.4.15 Victim Compensation payments

5.4.16 German reparation payments

5.4.17 Agent Orange settlement payments

5.4.18 Radiation Exposure Compensation Trust Fund payments

5.4.19 Japanese-American, Japanese-Canadian, and Aleutian restitution payments

5.4.20 Payments from long term care insurance or for inpatient care paid directly to the individual

5.5 Determination of the household income will be based on the family budget group, which is the total number of persons whose income is budgeted together. This will always include the following:

5.5.1 Married couples if they live together; and,

5.5.2 Unmarried couples who live together as a married couple.

5.5.3 Couples will be considered as living together as a married couple if:

5.5.3.1 They say they are married, even if the marriage cannot be verified; or,

5.5.3.2 They are recognized as a married couple in the community; or,

5.5.3.3 One partner uses the other's last name; or,

5.5.3.4 They state they intend to marry.

5.6 In households that include a caretaker, the caretaker's children and other children that are the caretaker's responsibility, the caretaker's income and those of his or her children are always budgeted together. The income of any other children in the home will be considered separately. In these situations, the separate budget groups can be combined to form a single family budget group only when the following conditions are met:

5.6.1 CTP benefits would be denied to any of the recipients by maintaining separate budget groups.

5.6.2 The caretaker chooses to have his or her income and those of his or her children considered with the income of any other people in the home.

**History**
- *8 DE Reg 1144 (2/1/05)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *8 DE Reg 1144 (2/1/05)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *11 DE Reg 680 (11/01/07)*
- *18 DE Reg. 67 (07/01/14)*
- *11 DE Reg 680 (11/01/07)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *8 DE Reg. 107 (7/1/04)*
- *18 DE Reg. 67 (07/01/14)*

##### **16 Del. Admin. Code § 4203-6.0** Residency {#sec-4203-6.0 omnilex-key=us-de-regs-official--title-16--4203-6.0}

6.1 A Delaware resident is an individual who lives in Delaware with the intention to remain or where the individual is living and has entered into a job commitment, or seeking employment whether or not currently employed.

6.2 Factors that may be taken into account when determining residency are variables such as the applicant’s age, location of dwellings and addresses, location of work, institutional status, and ability to express intent.

6.3 Eligibility:

6.3.1 Will not be denied to an otherwise qualified resident of the State because the individual's residence is not maintained permanently or at a fixed address.

6.3.2 Will not be denied to an institutionalized individual because the individual did not establish residence in the community prior to admission to an institution.

6.3.3 Will not be terminated due to temporary absence from the State, if the person intends to return when the purpose of the absence has been accomplished.

6.4 When a State or agency of the State, including an entity recognized under State law as being under contract with the State, arranges for an individual to be placed in an institution in another State, the State arranging that placement is the individual's State of residence.

**History**
- *8 DE Reg 1144 (2/1/05)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *8 DE Reg 1144 (2/1/05)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *11 DE Reg 680 (11/01/07)*
- *18 DE Reg. 67 (07/01/14)*
- *11 DE Reg 680 (11/01/07)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *8 DE Reg. 107 (7/1/04)*
- *18 DE Reg. 67 (07/01/14)*

##### **16 Del. Admin. Code § 4203-7.0** Verification Of Eligibility Information {#sec-4203-7.0 omnilex-key=us-de-regs-official--title-16--4203-7.0}

7.1 The CTP will verify information related to eligibility. Verification may be verbal or written and may be obtained from an independent or collateral source.

7.2 Documentation shall be date stamped and become part of the CTP case record.

7.3 Verifications received and/or provided may reveal a new eligibility issue not previously realized. Additional verifications may be required.

7.4 Failure to provide requested documentation will result in denial or termination of eligibility.

**History**
- *8 DE Reg 1144 (2/1/05)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *8 DE Reg 1144 (2/1/05)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *11 DE Reg 680 (11/01/07)*
- *18 DE Reg. 67 (07/01/14)*
- *11 DE Reg 680 (11/01/07)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *8 DE Reg. 107 (7/1/04)*
- *18 DE Reg. 67 (07/01/14)*

##### **16 Del. Admin. Code § 4203-8.0** Disposition Of Applications {#sec-4203-8.0 omnilex-key=us-de-regs-official--title-16--4203-8.0}

8.1 The CTP will dispose of each application by a finding of full eligibility, temporary eligibility or ineligibility, unless:

8.1.1 There is an entry in the case record that the applicant voluntarily withdrew the application, and that the CTP sent a notice confirming the applicant’s decision;

8.1.2 There is a supporting entry in the case record that the applicant is deceased; or

8.1.3 There is a supporting entry in the case record that the applicant cannot be located.

8.2 Disposition definitions:

8.2.1 Full eligibility - applicants provided full eligibility in the CTP meet all technical, income and residency eligibility requirements

8.2.2 Temporary eligibility - applicants provided temporary eligibility meet all technical, income and residency eligibility requirements except 4.1.5

8.2.3 Ineligibility - applicants do not meet one or more of the technical, income and/or residency eligibility requirements

**History**
- *8 DE Reg 1144 (2/1/05)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *8 DE Reg 1144 (2/1/05)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *11 DE Reg 680 (11/01/07)*
- *18 DE Reg. 67 (07/01/14)*
- *11 DE Reg 680 (11/01/07)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *8 DE Reg. 107 (7/1/04)*
- *18 DE Reg. 67 (07/01/14)*

##### **16 Del. Admin. Code § 4203-9.0** Temporary Eligibility {#sec-4203-9.0 omnilex-key=us-de-regs-official--title-16--4203-9.0}

9.1 Applicants provided temporary eligibility in the CTP are not exempt from the requirements to buy health insurance coverage per the PPACA.

9.2 Applicants provided temporary eligibility in the CTP are only afforded coverage under the CTP until such time as they can obtain health insurance coverage either through an employer or through the individual health insurance marketplace.

9.2.1 CTP applicants can obtain individual health insurance coverage during the annual health insurance coverage open enrollment period on the individual health insurance marketplace.

9.3 After such time as the applicant can obtain health insurance coverage through means listed in 9.2, the CTP enrollee will be terminated from the CTP, regardless of whether the individual has followed through with obtaining health insurance coverage.

**History**
- *8 DE Reg 1144 (2/1/05)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *8 DE Reg 1144 (2/1/05)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *11 DE Reg 680 (11/01/07)*
- *18 DE Reg. 67 (07/01/14)*
- *11 DE Reg 680 (11/01/07)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *8 DE Reg. 107 (7/1/04)*
- *18 DE Reg. 67 (07/01/14)*

##### **16 Del. Admin. Code § 4203-10.0** Termination Of Eligibility {#sec-4203-10.0 omnilex-key=us-de-regs-official--title-16--4203-10.0}

10.1 Eligibility terminates:

10.1.1 When the enrollee attains other medical insurance as listed in 4.1.4.

10.1.2 When the enrollee is no longer receiving treatment for cancer as defined in 4.1.1.

10.1.3 When the enrollee no longer meets the technical or financial eligibility requirements.

10.1.4 When applicants provided temporary eligibility status fail to obtain health insurance coverage or satisfy the requirements to transition to full eligibility status.

10.1.5 Twenty-four months after the date that cancer treatment is initiated for each primary cancer diagnosis.

10.2 If eligibility is terminated, it may only be renewed for an individual who is diagnosed with a new primary cancer. An individual who has a recurrence of cancer for which coverage has been previously provided is not eligible for additional coverage. The determination of a new primary cancer or recurring cancer is made by the treating physician.

10.3 When temporary eligibility is terminated or a disposition of ineligibility is received, applicants may request a financial hardship waiver and submit to DHSS for review to determine if a significant financial hardship exists for the applicant.

**History**
- *8 DE Reg 1144 (2/1/05)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *8 DE Reg 1144 (2/1/05)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *11 DE Reg 680 (11/01/07)*
- *18 DE Reg. 67 (07/01/14)*
- *11 DE Reg 680 (11/01/07)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *8 DE Reg. 107 (7/1/04)*
- *18 DE Reg. 67 (07/01/14)*

##### **16 Del. Admin. Code § 4203-11.0** Coverage And Benefits {#sec-4203-11.0 omnilex-key=us-de-regs-official--title-16--4203-11.0}

11.1 Coverage is limited to the treatment of cancer as defined by DHSS.

11.2 There is no managed care enrollment.

11.3 Benefits will be paid at rates equivalent to Medicaid under a fee for service basis. If a Medicaid rate does not exist for the service provided, the CTP will determine a fair rate.

11.4 Benefits will only be paid when the provider of the cancer treatment services is a Delaware Medicaid Assistance Provider.

11.5 Benefits for patients enrolled prior to September 1, 2004 (or whatever date is established by DHSS as having an operational benefits management information system), may not be paid until after that date.

11.6 The CTP is the payer of last resort and will only provide benefits to the extent that they are not otherwise covered by another insurance plan.

11.7 Eligibility may be retroactive to the day that cancer treatment was initiated provided that the application is filed within one year of that day. In such circumstances, covered services will only be provided for the time period that the applicant is determined to have been eligible for the CTP.

11.8 In no case will eligibility be retroactive to a time period prior to July 1, 2004, except if the enrollee was receiving benefits for the treatment of colorectal cancer through the Division of Public Health’s Screening for Life program on June 30, 2004. If this exception occurs, eligibility will be retroactive only to the date the enrollee was receiving benefits for colorectal cancer treatment through the Screening for Life program.

**History**
- *8 DE Reg 1144 (2/1/05)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *8 DE Reg 1144 (2/1/05)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *11 DE Reg 680 (11/01/07)*
- *18 DE Reg. 67 (07/01/14)*
- *11 DE Reg 680 (11/01/07)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *8 DE Reg. 107 (7/1/04)*
- *18 DE Reg. 67 (07/01/14)*

##### **16 Del. Admin. Code § 4203-12.0** Cancer Treatment Services Which Are Not Covered {#sec-4203-12.0 omnilex-key=us-de-regs-official--title-16--4203-12.0}

12.1 The cost of nursing home or long-term care institutionalization is not covered. (The cost of cancer treatment services within a nursing home or long term care institution is a covered benefit.)

12.2 Services not related to the treatment of cancer as determined by DHSS are not covered.

12.3 Cancer treatment services for which the enrollee is eligible to receive by other health plans as listed in 4.1.4.2 are not covered.

**History**
- *8 DE Reg 1144 (2/1/05)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *8 DE Reg 1144 (2/1/05)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *11 DE Reg 680 (11/01/07)*
- *18 DE Reg. 67 (07/01/14)*
- *11 DE Reg 680 (11/01/07)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *8 DE Reg. 107 (7/1/04)*
- *18 DE Reg. 67 (07/01/14)*

##### **16 Del. Admin. Code § 4203-13.0** Changes In Circumstances And Personal Information {#sec-4203-13.0 omnilex-key=us-de-regs-official--title-16--4203-13.0}

13.1 Enrollees are responsible for notifying the CTP of all changes in his or her circumstances that could potentially affect eligibility for the CTP. Failure to do so may result in overpayments being processed and legal action taken to recover funds expended on his or her behalf during periods of ineligibility.

13.2 Enrollees are responsible for notifying the CTP of changes in the enrollee’s name, address and telephone number.

**History**
- *8 DE Reg 1144 (2/1/05)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *8 DE Reg 1144 (2/1/05)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *11 DE Reg 680 (11/01/07)*
- *18 DE Reg. 67 (07/01/14)*
- *11 DE Reg 680 (11/01/07)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *8 DE Reg. 107 (7/1/04)*
- *18 DE Reg. 67 (07/01/14)*

##### **16 Del. Admin. Code § 4203-14.0** Changes In Program Services {#sec-4203-14.0 omnilex-key=us-de-regs-official--title-16--4203-14.0}

When changes in program services require adjustments of CTP benefits, the CTP will notify enrollees who have provided an accurate and current name, and address or telephone number.

**History**
- *8 DE Reg 1144 (2/1/05)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *8 DE Reg 1144 (2/1/05)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *11 DE Reg 680 (11/01/07)*
- *18 DE Reg. 67 (07/01/14)*
- *11 DE Reg 680 (11/01/07)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *8 DE Reg. 107 (7/1/04)*
- *18 DE Reg. 67 (07/01/14)*

##### **16 Del. Admin. Code § 4203-15.0** Confidentiality {#sec-4203-15.0 omnilex-key=us-de-regs-official--title-16--4203-15.0}

The CTP will maintain the confidentiality of application, claim, and related records as required by law.

**History**
- *8 DE Reg 1144 (2/1/05)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *8 DE Reg 1144 (2/1/05)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *11 DE Reg 680 (11/01/07)*
- *18 DE Reg. 67 (07/01/14)*
- *11 DE Reg 680 (11/01/07)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *8 DE Reg. 107 (7/1/04)*
- *18 DE Reg. 67 (07/01/14)*

##### **16 Del. Admin. Code § 4203-16.0** Review Of CTP Decisions {#sec-4203-16.0 omnilex-key=us-de-regs-official--title-16--4203-16.0}

16.1 Any individual who is dissatisfied with a CTP decision may request a review of that decision.

16.2 Such request must be received by the CTP in writing within 30 days of the date of the decision in question.

16.3 The CTP will issue the results of its review in writing. The review will be final and not subject to further appeal.

**History**
- *8 DE Reg 1144 (2/1/05)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *8 DE Reg 1144 (2/1/05)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *11 DE Reg 680 (11/01/07)*
- *18 DE Reg. 67 (07/01/14)*
- *11 DE Reg 680 (11/01/07)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *18 DE Reg. 67 (07/01/14)*
- *8 DE Reg. 107 (7/1/04)*
- *18 DE Reg. 67 (07/01/14)*

#### **4205** Vital Statistics

##### **16 Del. Admin. Code § 4205** Vital Statistics {#sec-4205 omnilex-key=us-de-regs-official--title-16--4205}

16 Del.C. §3104 has established in the Division of Public Health an Office of Vital Statistics which shall install, maintain and operate the only system of vital statistics throughout this State. The Office of Vital Statistics shall have branch offices in each county. The Department of Health and Social Services shall designate one such branch as the central Office of Vital Statistics, and this branch shall be responsible for the supervision of the operation of the other vital statistics offices throughout this State.

**History**
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*

##### **16 Del. Admin. Code § 4205-1.0** Duties and Responsibilities of Branch Offices {#sec-4205-1.0 omnilex-key=us-de-regs-official--title-16--4205-1.0}

(Authorization: Section 3105)

1.1 The State Registrar may delegate such duties and responsibilities to branch offices as he or she deems necessary to insure the efficient operation of the system of vital statistics. These duties may include any or all of the following:

1.1.1 The receipt, processing, and maintenance of records of birth, death, fetal death, and marriage occurring within their respective counties. This includes the receipt of these records from the person responsible for their filing, checking them for accuracy and completeness, and forwarding them to the central Office of Vital Statistics at intervals prescribed by the State Registrar.

1.1.2 Issuance of certified copies of birth, death, fetal death and marriage records. The records from which the certified copies are issued shall be those maintained in the branch office or shall be provided by the central Office of Vital Statistics. All forms and procedures used to issue the certified copies shall be provided or approved by the State Registrar. If it is deemed appropriate and feasible, any branch office may be provided access to all birth, death and marriage records filed in Delaware.

1.1.3 Acting as the agent of the State Registrar in their designated area and providing assistance to physicians, hospitals, funeral directors, and others in matters related to the system of vital statistics.

1.1.4 Performing such other duties as may be prescribed by the State Registrar.

**History**
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*

##### **16 Del. Admin. Code § 4205-2.0** Record Preservation {#sec-4205-2.0 omnilex-key=us-de-regs-official--title-16--4205-2.0}

(Authorization: Section 3107)

2.1 When an authorized reproduction of a vital record has been properly prepared by the State Registrar in accordance with 29 Del.C. Ch. 5 and when all steps have been taken to insure the continued preservation of the information, the record from which such authorized reproduction was made may be disposed of in accordance with an approved disposition schedule. Such record may not be disposed of, however, until the quality of the authorized reproduction has been tested in accordance with 29 Del.C. Ch. 5 to insure that acceptable certified copies can be issued and until a security copy of such document has been placed in a secure location removed from the building where the authorized reproduction is housed. Such security copy shall be maintained in such a manner to insure that it can replace the authorized reproduction should the authorized reproduction be lost or destroyed.

2.2 The State Registrar shall update the appropriate retention and disposition schedules as necessary. The State Division of Historical and Cultural Affairs shall adhere to applicable state laws and regulations pertaining to vital records.

**History**
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*

##### **16 Del. Admin. Code § 4205-3.0** Form and Completion of Certificates and Reports {#sec-4205-3.0 omnilex-key=us-de-regs-official--title-16--4205-3.0}

(Authorization: Sections 3108 and 3109)

3.1 Media, Forms, Certificates, Electronic Data Files. All forms, certificates, records, electronic data files, and reports used in the system of vital statistics are the property of the Department of Health and Social Services and shall be surrendered to the State Registrar upon demand. The forms prescribed and distributed by the State Registrar for reporting vital statistics shall be used only for official purposes. Only those forms furnished or approved by the State Registrar shall be used in the reporting of vital statistics or in making copies thereof. Electronic data records shall be accepted only when standards set by the State Registrar are met.

3.2 Requirements for Preparation of Certificates. All forms, certificates, and reports relating to vital statistics must either be type written or printed legibly in black, unfading ink, or stored on electronic media approved by the State Registrar. All signatures required shall be entered in black, unfading ink or stored electronically. Unless otherwise directed by the State Registrar, no certificate shall be complete and correct and acceptable for registration:

3.2.1 That does not contain the certifier's name typed or printed legibly;

3.2.2 that does not supply all items of information called for thereon or satisfactorily account for their omission;

3.2.3 that contains alterations or erasures;

3.2.4 that does not contain handwritten signatures as required;

3.2.5 that is marked "copy" or "duplicate";

3.2.6 that is a carbon copy;

3.2.7 that is prepared on an improper form;

3.2.8 that contains improper or inconsistent data;

3.2.9 that contains an indefinite cause of death which denotes only symptoms of disease or conditions resulting from disease;

3.2.10 that is not prepared in conformity with regulations or instructions issued by the State Registrar.

**History**
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*

##### **16 Del. Admin. Code § 4205-4.0** Disclosure and Copies of Data from Vital Records {#sec-4205-4.0 omnilex-key=us-de-regs-official--title-16--4205-4.0}

(Authorization: Section 3110)

4.1 To protect the integrity of vital records:

4.1.1 The State Registrar or other custodians of vital records shall not permit inspection of these records, or disclose information contained in vital statistics records, or copy or issue a copy of all or part of any such record unless he or she is satisfied that the applicant is authorized to obtain a copy or abstract of such record.

4.1.1.1 Family members doing genealogical research and genealogists representing a family member may obtain copies of records needed for their research. Unless the registrant is deceased, appropriate authorizations shall be required from the registrant or relevant family members as defined in section 3110(b) for the release of the records. If family members, or genealogists representing them, are unable to establish the death of a registrant or to identify those closer family members authorized by Section 3110(b), they may obtain copies of marriage and death records only upon presentation of evidence satisfactory to the State Registrar that they are directly descended from a parent or grandparent of the registrant.

4.1.1.2 The term "authorized representative" shall include an attorney, physician, funeral director, or other designated agent acting in behalf of the registrant or his or her family.

4.1.1.3 The natural parents of adopted children, when neither has custody, and commercial firms or agencies requesting listings of names and addresses shall not be authorized to obtain copies or abstracts of the record.

4.1.2 The State Registrar or local custodian shall not issue a certified copy of a record until the applicant has provided sufficient information to locate the record. Whenever it shall be deemed necessary to establish an applicant's right to information from a vital record, the State Registrar or local custodian may also require identification of the applicant or a sworn statement.

4.1.3 When 72 years have elapsed after the date of birth, or 40 years have elapsed after the date of death or marriage, such records in the custody of the State Registrar shall become available to any person upon submission of an application containing sufficient information to locate the record. The State Registrar shall collect the same fee for each copy issued or search of the files made, as is charged for a single certified copy. The same fee shall apply for vital records in the possession of the Division of Historical and Cultural Affairs.

4.1.4 All forms and procedures used in the issuance of certified copies of vital records in the state shall be uniform and provided or approved by the State Registrar. All certified copies issued shall have security features that deter the document from being altered, counterfeited, duplicated, or simulated without ready detection. All certified copies shall include, at a minimum, the following security features:

4.1.4.1 sensitized security paper;

4.1.4.2 background security design;

4.1.4.3 copy void pantograph;

4.1.4.4 consecutive numbering;

4.1.4.5 engraved border;

4.1.5 A certified copy or other copy of a death certificate containing the cause of death information shall not be issued except as follows:

4.1.5.1 Upon specific request of the spouse, children, parents, or other next of kin of the decedent or their respective authorized representatives; or

4.1.5.2 when a documented need for the cause of death to establish a legal right or claim has been demonstrated; or

4.1.5.3 when the request for the copy is made by or on behalf of an organization that provides benefits to the decedent's survivors or beneficiaries; or

4.1.5.4 upon specific request by local, state, or Federal agencies for research or administrative purposes approved by the Department of Health and Social Services; or

4.1.5.5 when needed for statistical or research activities provided requests for such information conform to the Regulations Governing The Release of Vital Statistics Data For Research And Statistical Purposes established by the Department of Health and Social Services; or

4.1.5.6 upon receipt of an order from a court of competent jurisdiction ordering such release.

4.1.6 Nothing in these regulations shall be construed to permit disclosure of information contained in the "Information for Medical and Health Use Only" section of the certificate of birth or the "Information for Statistical Purposes Only" section of the certificate of marriage or certificate of divorce or annulment unless specifically authorized by the Department of Health and Social Services for statistical or research purposes. Such data shall not be subject to subpoena or court order and shall not be admissible before any court, tribunal, or other judicial body.

4.1.7 When the State Registrar receives information that a certificate may have been registered through fraud or misrepresentation, he or she shall withhold issuance of any copy of that certificate pending an administrative hearing. The sole purpose of the hearing shall be to determine whether there is sufficient evidence to continue to withhold issuance of copies of said certificate. The State Registrar shall offer the registrant or the registrant's authorized representative notice and opportunity to be heard. If upon conclusion of the hearing no fraud or misrepresentation is found, copies may be issued. If upon conclusion of the hearing fraud or misrepresentation is found, the State Registrar shall remove the certificate from the file. The certificate and evidence shall be retained but shall not be subject to inspection or copying except upon order of a court of competent jurisdiction or by the State Registrar for purposes of administering the vital statistics program.

**History**
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*

##### **16 Del. Admin. Code § 4205-5.0** Birth Registration {#sec-4205-5.0 omnilex-key=us-de-regs-official--title-16--4205-5.0}

(Authorization: Section 3121)

5.1 Out-of-Institution Birth - Documentary Evidence.

5.1.1 When a birth occurs in Delaware outside of a hospital or institution, and the birth certificate is filed before six months, additional evidence in support of the facts of birth may be required.

5.1.2 A certificate for the birth shall be completed and filed upon presentation of the following evidence by the individual responsible for filing the certificate:

5.1.2.1 Evidence of pregnancy, such as but not limited to:

5.1.2.1.1 Prenatal record, or

5.1.2.1.2 a statement from a physician or other health care provider qualified to determine pregnancy, or

5.1.2.1.3 a home visit by a public health nurse or other health care provider, or

5.1.2.1.4 other evidence acceptable to the State Registrar.

5.1.2.2 Evidence that the infant was born alive, such as but not limited to:

5.1.2.2.1 A statement from the physician or other health care provider who saw or examined the infant, or

5.1.2.2.2 an observation of the infant during a home visit by a public health nurse, or

5.1.2.2.3 other evidence acceptable to the State Registrar.

5.1.2.3 Evidence of the mother's presence in this state on the date of the birth, such as but not limited to:

5.1.2.3.1 If the birth occurred in the mother's residence,

5.1.2.3.1.1 A driver's license, or a state-issued identification card, which includes the mother's current residence on the face of the license/card, or

5.1.2.3.1.2 a rent receipt that includes the mother's name and address, or

5.1.2.3.1.3 any type of utility, telephone, or other bill that includes the mother's name and address, or

5.1.2.3.1.4 other evidence acceptable to the State Registrar.

5.1.2.3.2 If the birth occurred outside of the mother's place of residence, and the mother is a resident of Delaware, such evidence shall consist of:

5.1.2.3.2.1 An affidavit from the tenant of the premises where the birth occurred, that the mother was present on those premises at the time of the birth, and

5.1.2.3.2.2 evidence of the affiant's residence similar to that required in subsection 5.1.2.3.1 of this regulation, and

5.1.2.3.2.3 evidence of the mother's residence in Delaware similar to that required in subsection 5.1.2.3.1 of this regulation, or

5.1.2.3.2.4 Other evidence acceptable to the State Registrar.

5.1.2.3.3 If the mother is not a resident of Delaware, such evidence must consist of clear and convincing evidence acceptable to the State Registrar.

5.2 Determination of Mother.

5.2.1 For the purposes of birth registration, the mother is deemed to be the woman who gives birth to the child, unless otherwise provided by state law or determined by a court of competent jurisdiction prior to the filing of the birth certificate.

**History**
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*

##### **16 Del. Admin. Code § 4205-6.0** Infants of Unknown Parentage; Foundling Registration {#sec-4205-6.0 omnilex-key=us-de-regs-official--title-16--4205-6.0}

(Authorization: Section 3122)

6.1 The report for an infant of unknown parentage shall be registered on a current certificate of live birth and shall:

6.1.1 Have "foundling" plainly marked in the top margin of the certificate;

6.1.2 show the required facts as determined by approximation and have parentage data left blank;

6.1.3 show the name and title of the custodian in lieu of the attendant.

6.2 If a report of a foundling is later placed in a special file as provided by Section 3122(d) of the Delaware Code, the State Registrar may inspect such information for purposes of properly administering the vital statistics program or as otherwise provided by state law.

**History**
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*

##### **16 Del. Admin. Code § 4205-7.0** Death Registration {#sec-4205-7.0 omnilex-key=us-de-regs-official--title-16--4205-7.0}

(Authorization: Section 3123)

7.1 Acceptance of Death Certificate with Incomplete Personal Information.

7.1.1 If all the personal information necessary to complete a certificate of death is not available within the time prescribed for filing of the certificate, the funeral director or person acting as such, shall file the certificate with all information that is available and satisfactorily account for all the items that are omitted.

7.1.2 A supplemental report providing the personal information omitted from the original certificate shall be filed by the funeral director or person acting as such with the State Registrar as soon as possible, but in all cases within 30 days of the date the death occurred.

7.1.3 The supplemental report shall be used to revise the existing certificate of death; and the certificate of death shall be marked "Revised".

7.2 Replacement of Pending Certificate

7.2.1 When a pending certificate of death is filed pursuant to Section 3123(e), a revised certificate of death providing the medical information omitted from the original certificate shall be completed by the certifier within thirty days of the date the death occurred, or within sixty days if an extension has been applied for through the State Registrar. The revised certificate shall be forwarded to the funeral director or person acting as such. The funeral director will complete all the personal information and file the revised certificate of death with the Office of Vital Statistics. The revised certificate of death shall replace the pending certificate of death and shall be considered the original. Such certificate shall not be marked "Revised".

7.3 Hospital or Institution May Assist in Preparation of Certificate. When a death occurs in a hospital or other institution and the death is not under the jurisdiction of the medical examiner, the person in charge of such institution, or his or her designated representative, may initiate the preparation of the certificate of death as follows:

7.3.1 Place the full name of the decedent and the date, time, and place of death on the certificate of death and obtain the medical certification of cause of death from the attending physician or;

7.3.2 Place the full name of the decedent and the date, time, and place of death on the certificate of death and obtain the pronouncing physician's attestation.

7.3.3 Present the partially completed certificate of death to the funeral director or person acting as such.

**History**
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*

##### **16 Del. Admin. Code § 4205-8.0** Adoption {#sec-4205-8.0 omnilex-key=us-de-regs-official--title-16--4205-8.0}

(Authorization: Section 3126)

8.1 Certificates.

8.1.1 Whenever an adoption decree is amended or annulled, the clerk of the court shall prepare a report thereof. This report shall include such facts as are necessary to identify the original certificate of adoption and the facts amended in the adoption decree as shall be necessary to properly amend the birth record.

8.1.2 When the State Registrar shall receive a certificate of adoption, report of annulment of adoption, or amendment of a decree of adoption for a person born outside Delaware, he or she shall forward such certificate or report to the State Registrar in the state of birth.

8.2 New Certificate.

8.2.1 The new certificate of birth prepared after adoption shall be on the form in use at the time of its preparation and shall include the following items and such other information necessary to complete the certificate:

8.2.1.1 The name of the child;

8.2.1.2 the date and city and/or county of birth as transcribed from the original certificate;

8.2.1.3 the names and personal particulars of the adoptive parents;

8.2.1.4 the name of the attendant, printed or typed;

8.2.1.5 the State File number assigned to the original certificate of birth;

8.2.1.6 the original filing date

8.2.2 The information necessary to locate the existing certificate and to complete the new certificate shall be submitted to the State Registrar on forms prescribed or approved by him or her.

8.3 Existing Certificate to Be Placed in a Special File. After preparation of the new certificate, the existing certificate and the evidence upon which the new certificate was based shall be placed in a special file. Such file shall not be subject to inspection except upon order of a court of competent jurisdiction or by the State Registrar for purposes of properly administering the vital statistics program or as otherwise provided by state law.

**History**
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*

##### **16 Del. Admin. Code § 4205-9.0** Acknowledgement or Establishment of Paternity {#sec-4205-9.0 omnilex-key=us-de-regs-official--title-16--4205-9.0}

(Authorization: Section 3127)

9.1 The new certificate of birth prepared after acknowledgement or establishment of paternity shall be on the form in use at the time of its preparation and shall include the following items and such other information necessary to complete the certificate:

9.1.1 The name of the child;

9.1.2 the date and city and/or county of birth as transcribed from the original certificate;

9.1.3 the names and personal particulars of the natural parents;

9.1.4 the name of the attendant, printed or typed;

9.1.5 the State File number assigned to the original certificate of birth;

9.1.6 the original filing date.

9.2 The information necessary to locate the existing certificate and to complete the new certificate shall be submitted to the State Registrar on forms prescribed or approved by him or her.

**History**
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*

##### **16 Del. Admin. Code § 4205-10.0** Amendment of Vital Records {#sec-4205-10.0 omnilex-key=us-de-regs-official--title-16--4205-10.0}

(Authorization: Section 3131)

10.1 Amendment of Minor Errors on Birth Certificates During the First Year. Amendment of obvious errors, transposition of letters in words of common knowledge, or obvious omissions may be made by the State Registrar within the first year after the date of birth either upon his or her own observation or query or upon request of a person as defined in subsection 10.3. When such additions or minor amendments are made by the State Registrar, a notation as to the source of the information, together with the date the change was made and the initials of the authorized agent making the change shall be made on the certificate in such a way as not to become a part of any certified copy issued. The certificate shall not be marked "Amended."

10.2 All Other Amendments. Unless otherwise provided in these regulations or in the statute, all other amendments to vital records shall be supported by:

10.2.1 An affidavit setting forth:

10.2.1.1 Information to identify the certificate;

10.2.1.2 the incorrect data as it is listed on the certificate;

10.2.1.3 the correct data as it should appear; and

10.2.2 One or more items of documentary evidence which support the alleged facts and which were established at least five years prior to the date of application for amendment or within seven years of the date of the event.

10.2.3 The State Registrar shall evaluate the evidence submitted in support of any amendment, and when he or she finds reason to doubt its validity or adequacy, the amendment may be rejected and the applicant advised of the reasons for this action.

10.3 Who May Apply.

10.3.1 To amend a certificate of birth, application may be made by one of the parents, if the registrant is under age 18; the guardian, the registrant if 18 years of age or over; or the individual responsible for filing the certificate.

10.3.2 To amend a certificate of death, application may be made by the next of kin, the informant listed on the certificate of death, or the funeral director or person acting as such who submitted the certificate of death. Applications to amend the medical certification of cause of death may be made only by the physician who provided the medical certification or the medical examiner.

10.3.3 To amend a certificate of marriage, application must be made jointly by both parties to the marriage or by the survivor. In the event the marriage to which the application relates was terminated by divorce or annulment on or before the date of application for amendment, the applicant may request amendment only of those items on the certificate of marriage which relate to the applicant.

10.4 Amendment of Registrant's Given Names on Certificates of Birth Within the First Year.

10.4.1 Until the registrant's first birthday, given names may be amended upon receipt of an affidavit signed by the parent(s) named on the certificate or the guardian, person, or agency having legal custody of the registrant.

10.4.2 After one year from the date of birth the provisions of subsection 10.2 must be followed to amend a given name if the name was entered incorrectly on the certificate of birth. A legal change of name order must be submitted from a court of competent jurisdiction to change a given name after one year.

10.5 Addition of Given Names on Certificates of Birth.

10.5.1 Until the registrant's seventh birthday, given names, for a child whose birth was recorded without given names, may be added to the certificate upon receipt of an affidavit signed by the parent(s) named on the certificate or the guardian, person, or agency having legal custody of the registrant.

10.5.2 After seven years the provisions of subsection 10.2 must be followed to add a given name.

10.6 Legal Change of Name. Upon receipt of a certified copy of an order of a court of competent jurisdiction changing the name of a person born in Delaware and upon request of such person or his or her parents, guardian, or legal representative, the State Registrar shall amend the certificate of birth to show the new name.

10.7 Amendment of Sex.

10.7.1 The Registrar shall establish a new certificate of birth that reflects the new sex upon receipt of the following documents:

10.7.1.1 An affidavit requesting a new certificate of birth with a sex that differs from the sex listed on the original certificate of birth of the registrant, or if the registrant is a minor, the registrant's parent, guardian, or legal representative; and

10.7.1.2 An affidavit signed by a licensed medical or mental health professional, licensed by a US jurisdiction in a relevant discipline, who has treated or evaluated the registrant, including license number and name of issuing jurisdiction of the professional stating that:

10.7.1.2.1 The registrant has undergone surgical, hormonal, psychological or other treatment appropriate for the individual for the purpose of gender transition, based on contemporary medical standards; or

10.7.1.2.2 The registrant has an intersex condition, and that in the provider's professional opinion, the individual's sex as listed on the original birth certificate should be changed.

10.7.2 If a change of name listed on the certificate is also being requested, the requirements listed in subsection 10.6 must be met.

10.7.3 The item numbers of the entries that were amended shall not be identified on the new certificate or on any certified copies that may be issued of that certificate.

10.7.4 Subsequent changes to sex on a registrant's birth certificate will be made in accordance with subsection 10.9 of these regulations.

10.8 Amendment of Cause of Death. The cause of death may be amended only upon receipt of a signed statement or an approved electronic notification from the physician or medical examiner who originally certified the cause of death. In the absence or inability of the physician or with his or her approval the cause of death may be amended upon receipt of a signed statement or an approved electronic notification from his or her associate physician, or the chief medical officer of the institution in which death occurred, or a medical examiner who assumes jurisdiction of the case provided such individual has access to the medical history of the case. The State Registrar may require documentary evidence to substantiate the requested amendment.

10.9 Amendment of the Same Item More than Once. Once an amendment of an item is made on a vital record, that item shall not be amended again except upon receipt of a court order from a court of competent jurisdiction.

10.10 Methods of Amending Certificates. Certificates of birth, death, and marriage may be amended by the State Registrar in the following manner:

10.10.1 Completing the item in any case where the item was left blank on the existing certificate.

10.10.2 Drawing a single line through the item to be amended and inserting the correct data immediately above or to the side thereof. The line drawn through the original entry shall not obliterate such entry.

10.10.3 Amending a record maintained in an electronic file by changing the item(s) to be amended. The date of the amendment must be made part of the record and the original information must also be retained.

10.11 Denial of Amendment. When an applicant does not submit the minimum documentation required for amending a vital record or when the State Registrar has cause to question the validity or adequacy of the applicant's sworn statements or the documentary evidence, and if the deficiencies are not corrected, the State Registrar shall not amend the vital record and shall advise the applicant of the reason for this action and shall further advise the applicant of the right of appeal to a court of competent jurisdiction.

10.12 Notification of Amendment.

10.12.1 When a certificate or report is amended under this section by the State Registrar, the State Registrar shall report the amendment to any other custodian of the vital record and their record shall be amended accordingly.

10.12.2 When an amendment is made to a certificate of marriage by the local official issuing the marriage license, copies of such amendment shall be forwarded to the State Registrar.

**History**
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*

##### **16 Del. Admin. Code § 4205-11.0** Delayed Registration of Birth {#sec-4205-11.0 omnilex-key=us-de-regs-official--title-16--4205-11.0}

(Authorization: Section 3131)

11.1 Delayed Certificate of Birth Form. All certificates registered six months or more after the date of birth are to be registered on a delayed certificate of birth form prescribed and furnished by the State Registrar.

11.2 Who May Request the Registration of a Delayed Certificate of Birth.

11.2.1 Any person born in Delaware whose birth is not recorded in the state, his/her parent or guardian, or any other person age 18 or older acting for the registrant and having personal knowledge of the facts of birth may request the registration of a delayed certificate of birth, subject to these regulations and instructions issued by the State Registrar.

11.2.2 Each application for a delayed certificate of birth shall be signed and sworn to before an official authorized to administer oaths by the person whose birth is to be registered if such person is 18 years of age or over and is competent to sign and swear to the accuracy of the facts stated therein; otherwise the application shall be signed and sworn to by one of the parents of the registrant, his/her guardian, or any other person age 18 or older having personal knowledge of the facts of birth.

11.3 Facts to be Established for a Delayed Registration of Birth. The minimum facts which must be established by documentary evidence shall be the following:

11.3.1 The full name of the person at the time of birth;

11.3.2 the date of birth and state of birth;

11.3.3 the full maiden name of the mother;

11.3.4 the full name of the father; except that if the mother was not married either at the time of conception or birth the name of the father shall not be entered on the delayed certificate except as provided in subsection 11.4.

11.4 Delayed Registration Following a Legal Change of Status. When evidence is presented reflecting a legal change of status by adoption, legitimation, or acknowledgment of paternity, a new delayed certificate may be established to reflect such change. The existing certificate and the evidence upon which the new certificate was based shall be placed in a special file. Such file shall not be subject to inspection except upon order of a court of competent jurisdiction or by the State Registrar for purposes of properly administering the vital statistics program.

11.5 Documentary Evidence - Requirements.

11.5.1 To be acceptable for filing, the name of the registrant at the time of the birth and the date and place of birth entered on a delayed certificate of birth shall be supported by at least:

11.5.1.1 A hospital record created at the time of birth, or two pieces of acceptable documentary evidence, if the record is filed within ten years after the date of birth; or

11.5.1.2 three pieces of acceptable documentary evidence, if the record is filed ten years or more after the date of birth.

11.5.2 Facts of parentage shall be supported by at least one document.

11.6 Documentary Evidence ‑ Acceptability. The State Registrar shall determine the acceptability of all documentary evidence submitted.

11.6.1 Documents presented, including but not limited to census, hospital, church, and school records, must be from independent sources and shall be in the form of the original record or a duly certified copy thereof or a signed statement from the custodian of the record or document. Affidavits of personal knowledge are not acceptable as evidence to establish a delayed certificate of birth.

11.6.2 All documents submitted in evidence:

11.6.2.1 For persons aged ten or older, must have been established at least ten years prior to the date of application, or within three years of the date of birth;

11.6.2.2 for persons under ten, must be dated at least one year prior to the date of application or within the first year of life.

11.7 Abstraction of Documentary Evidence.

11.7.1 The State Registrar, or his or her designated representative, shall abstract on the delayed certificate of birth a description of each document submitted to support the facts shown on the delayed birth certificate. This description shall include:

11.7.1.1 The title or description of the document;

11.7.1.2 the name and address of the custodian.

11.7.1.3 the date of the original filing of the document being abstracted;

11.7.1.4 all birth facts required by subsection 11.3 contained in each document accepted as evidence.

11.7.2 All documents submitted in support of the delayed birth registration shall be returned to the applicant after review.

11.8 Verification by the State Registrar. The State Registrar, or his or her designated representative shall verify:

11.8.1 That no prior birth certificate is on file for the person whose birth is to be recorded;

11.8.2 That he or she has reviewed the evidence submitted to establish the facts of birth;

11.8.3 That the abstract of the evidence appearing on the delayed certificate of birth accurately reflects the nature and content of the document.

11.9 Dismissal After One Year. Applications for delayed certificates which have not been completed within one year from the date of application may be dismissed at the discretion of the State Registrar. Upon dismissal, the State Registrar shall so advise the applicant and all documents submitted in support of such registration shall be returned to the applicant.

11.10 Delayed Registration for the Deceased. No delayed certificate of birth shall be registered for a deceased person.

11.11 Denial of Registration. When an applicant does not submit the minimum documentation required for delayed registration or when the State Registrar has cause to question the validity or adequacy of the applicant's sworn statement or the documentary evidence, and if the deficiencies are not corrected, the State Registrar shall not register the delayed certificate of birth and shall advise the applicant of the reasons for this action, and shall further advise the applicant of his or her right to seek an order from a court of competent jurisdiction.

**History**
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*

##### **16 Del. Admin. Code § 4205-12.0** Delayed Registration of Death {#sec-4205-12.0 omnilex-key=us-de-regs-official--title-16--4205-12.0}

(Authorization: Section 3131)

12.1 The registration of a death after the time prescribed by statute and regulations shall be registered on the current certificate of death form in the manner prescribed below:

12.1.1 If the attending physician or medical examiner at the time of death and the attending funeral director or person who acted as such are available to complete the certificate of death, it may be completed without additional evidence and filed with the State Registrar. For those certificates filed six months or more after the date of death, the physician or medical examiner and the funeral director or person who acted as such must state in accompanying affidavits that the information on the certificate is based on records kept in their files.

12.1.2 In the absence of the attending physician or medical examiner and the funeral director or person who acted as such, the certificate may be filed by the next of kin of the decedent and shall be accompanied by two documents which identify the decedent and his or her date and place of death.

12.2 In all cases, the State Registrar may require additional documentary evidence to prove the facts of death.

12.3 A summary statement of the evidence submitted in support of the delayed registration shall be endorsed on the certificate.

**History**
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*

##### **16 Del. Admin. Code § 4205-13.0** Delayed Registration of Marriage {#sec-4205-13.0 omnilex-key=us-de-regs-official--title-16--4205-13.0}

(Authorization: Section 3131)

13.1 The registration of a marriage after the time prescribed by statute shall be made on the current certificate of marriage form in the manner prescribed below:

13.1.1 The certificate must be filed with the Clerk of the Peace where the marriage license was originally issued.

13.1.2 To be acceptable for registration by the State Registrar the delayed certificate of marriage must be supported by:

13.1.2.1 A copy of the license or of the application for license if the license was granted, and

13.1.2.2 A signed statement from the officiant or the custodian of the records of the officiant and from one witness to the wedding ceremony indicating that a marriage ceremony was performed and the date and place of the marriage.

13.1.2.3 In all cases, the State Registrar may require additional documentary evidence to prove the facts of marriage.

13.1.2.4 When an applicant does not submit the minimum documentation required for delayed registration or when the State Registrar has cause to question the validity or adequacy of the statements or the documentary evidence, and if the deficiencies are not corrected, the State Registrar shall not register the delayed certificate of marriage and shall advise the applicant of the reasons for this action, and shall further advise the applicant of his or her right to seek an order from a court of competent jurisdiction.

**History**
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*
- *20 DE Reg. 641 (02/01/17)*

#### **4300** Emergency Medical Services (EMS)

#### **4304** Delaware Medical Orders for Scope of Treatment (DMOST)

##### **16 Del. Admin. Code § 4304** Delaware Medical Orders for Scope of Treatment (DMOST) {#sec-4304 omnilex-key=us-de-regs-official--title-16--4304}

4304 Delaware Medical Orders for Scope of Treatment (DMOST)

Purpose:

These DMOST regulations implement 16 Del.C. Ch. 25A which authorizes the Division of Public Health/Office of Emergency Medical Services, in conjunction with the Board of Medical Licensure and Discipline, the Delaware EMS Oversight Council, the Delaware State Fire Prevention Commission, and other key groups within the State to develop and implement DMOST regulations and protocol. These regulations, protocol, and form standardize documentation so that Emergency Medical Service (EMS) personnel and all health care providers have a readily recognizable form which sets forth a patient’s preferences regarding the provision of and the scope of treatment. The DMOST form allows EMS personnel and other health care providers both to identify and to honor an individual’s wishes to the greatest extent possible and to grant individuals the dignity, humanity, and compassion they deserve.

In order for EMS personnel to honor an individual’s request related to end-of-life decisions, the EMS provider must have a medical order. The DMOST form serves both as the summary of the individual’s advance health care planning decisions and as the medical order.

**History**
- *21 DE Reg. 233 (09/01/17)*
- *7 DE Reg. 85 (07/01/03)*
- *15 DE Reg. 211 (08/01/11)*
- *19 DE Reg. 637 (01/01/16)*
- *19 DE Reg. 922 (04/01/16)*
- *21 DE Reg. 233 (09/01/17)*
- *19 DE Reg. 922 (04/01/16)*
- *21 DE Reg. 233 (09/01/17)*

##### **16 Del. Admin. Code § 4304-1.0** Definitions {#sec-4304-1.0 omnilex-key=us-de-regs-official--title-16--4304-1.0}

"Advance Health-Care Directive (AHCD)” means an Advance Health-Care Directive under 16 Del.C. Ch. 25, a durable power of attorney for health care decisions, or any individual instruction or power of attorney for health care valid under Delaware law because it is valid in the state where such document was executed or where the individual executing such document was a resident at the time that such document appointing an agent was executed. Said document must have been executed by the individual authorizing the appointed agent to make decisions about the individual's health care when such individual no longer has decision-making capacity.

“Decision-making capacity” means a patient's ability to understand and appreciate the nature and consequences of a particular health care decision, including the benefits and risks of that decision and alternatives to any proposed health care treatment, and to reach an informed health care decision.

“Delaware Medical Orders for Scope of Treatment (DMOST)” means a clinical process to facilitate communication between health care professionals and a patient living with serious illness or frailty whose health care practitioner would not be surprised if the patient died within the next year or, if the patient lacks decision-making capacity, the patient’s authorized representative. The process encourages shared, informed medical decision-making. The decisions are memorialized on a completed DMOST form, which contains portable medical orders that respect the patient’s goals for care with respect to the use of CPR and other life-sustaining treatments and medical interventions. The DMOST form is applicable across health care settings, is reviewable, and the patient controls if it can be voided.

“Department” means the Department of Health and Social Services.

“DMOST form” means the standardized document created by the Department that is identified as an Attachment to these regulations, which:

“Emergency-care provider” means an emergency medical technician, paramedic, or first responder authorized under 16 Del.C. Ch 97.

“Health care institution” means an institution, facility, or agency licensed, certified or otherwise authorized or permitted by law to provide health care in the ordinary course of business.

“Health care practitioner” means a physician or an individual licensed and authorized to write medical orders pursuant to 24 Del.C. Ch. 17 and Ch. 19 who is providing care for the patient or overseeing the health care provided to the patient and has completed all training required by the Department for individuals participating in the completion of a DMOST form. Over time, a patient’s health care practitioner may change.

“Health care provider” means an individual licensed, certified, or otherwise authorized or permitted by law to provide health care in the ordinary course of business or practice of a profession. A health care practitioner is also a health care provider.

“Life-sustaining treatment” includes any medical intervention, including procedures, administration of medication, or use of a medical device, that maintains life by sustaining, restoring, or supplanting a vital function. It does not include care provided for the purpose of keeping a patient comfortable.

“Patient” means an individual who is under the care of the health care practitioner or health care provider.

“Patient’s authorized representative” or “authorized representative” means the individual signing a DMOST form on behalf of a patient without decision-making capacity, who has the highest priority to act for the patient under law, and who has the authority to make decisions with respect to the patient’s health care preferences being made on the DMOST form. The health care practitioner shall determine the individual who is the patient’s authorized representative by referencing the documentation giving such individual the required authority under law. Based on the documentation provided by such individual as evidence of his or her authority, the patient’s authorized representative could be an individual designated by a patient under an advance health-care directive, an agent under a medical durable power of attorney for health care decisions, a guardian of the person appointed pursuant to 12 Del.C. Ch. 39 or Ch. 39A, in accordance with the authority granted by the appointing court, a surrogate appointed under 16 Del.C. Ch. 25, or an individual who is otherwise authorized under applicable law to make the health care decisions being made by execution of the DMOST form on the patient’s behalf, if the patient lacks decision-making capacity.

“Scope of treatment” means those medical interventions, procedures, medications, and treatments that a patient, in consultation with a health care practitioner, has determined are appropriate, necessary, and desired by and for the patient and will always include the provision of comfort measures. A patient may decline life-sustaining treatment.

“Serious illness or frailty” means a condition for which a health care practitioner would not be surprised if a patient died within the next year.

**History**
- *21 DE Reg. 233 (09/01/17)*
- *7 DE Reg. 85 (07/01/03)*
- *15 DE Reg. 211 (08/01/11)*
- *19 DE Reg. 637 (01/01/16)*
- *19 DE Reg. 922 (04/01/16)*
- *21 DE Reg. 233 (09/01/17)*
- *19 DE Reg. 922 (04/01/16)*
- *21 DE Reg. 233 (09/01/17)*

##### **16 Del. Admin. Code § 4304-2.0** Form Description {#sec-4304-2.0 omnilex-key=us-de-regs-official--title-16--4304-2.0}

2.1 The DMOST form, including instructions for completion and plain language explanation, is published in these regulations. The DHSS documents in these regulations may not be altered.

2.1.1 The patient’s identification block has the patient’s name (last, first, middle), patient's address of record, patient's phone number, patient's gender, patient's date of birth, and last four digits of the patient’s social security number.

2.1.2 The Scope of Treatment sections are Blocks A to D.

2.1.2.1 Section A contains the goals of care. This section is for the patient to draft a goal statement relative to their current treatment plan. This section does not constitute a medical order.

2.1.2.2 Section B contains Cardiopulmonary Resuscitation decision (when the patient has no pulse and/or is not breathing). This section constitutes a medical order.

2.1.2.3 Section C contains Medical Interventions (when patient is breathing and/or has a pulse). This section has four categories to be answered. This section constitutes a medical order.

2.1.2.3.1 Treatment of symptoms only/Comfort Measures Only. Use any medications, including pain medication, by any route, positioning, wound care, and other measures to keep clean, warm, dry, and comfortable. Use of oxygen, oral suctioning and manual treatment of airway obstruction as needed for comfort. Use antibiotics only to promote comfort. Transfer if comfort needs cannot be met in current location.

2.1.2.3.2 Limited Treatment. Includes care described above, and use appropriate medical treatment such as antibiotics and IV fluids, and cardiac monitoring as indicated. Do not use intubation or mechanical ventilations. May use non-invasive airway support that does not require the introduction of instruments into the body [e.g. CPAP, BIPAP] however if clearing the airway with manual techniques is unsuccessful, direct laryngoscopy and the use of Magill Forceps may be used. Generally avoid intensive care and transfer to hospital if ordered for medical interventions or if ordered because comfort needs cannot be met in current location.

2.1.2.3.3 Full Treatment. Includes care described above, and use all appropriate medical and surgical interventions, including intubation, advanced airway interventions, mechanical ventilation, and cardioversion, in an intensive care setting if indicated to support life. Transfer to a hospital, if indicated, including intensive care.

2.1.2.3.4 Other orders. Provide the care stated.

2.1.2.4 Section D contains the blocks to determine the desire for the artificially administered fluids and nutrition.

2.1.2.5 Section E contains information as to whom the DMOST form was discussed with and it contains a signature block where the patient, if they have decision-making capacity, can prohibit an authorized representative from voiding the DMOST form and executing a new DMOST form that changes the treatment choices if the patient loses decision-making capacity.

2.1.3 The Signature. Section F contains the signature areas for the patient/authorized representative/parent and the health care practitioner. To be valid the form must have both required signatures.

**History**
- *21 DE Reg. 233 (09/01/17)*
- *7 DE Reg. 85 (07/01/03)*
- *15 DE Reg. 211 (08/01/11)*
- *19 DE Reg. 637 (01/01/16)*
- *19 DE Reg. 922 (04/01/16)*
- *21 DE Reg. 233 (09/01/17)*
- *19 DE Reg. 922 (04/01/16)*
- *21 DE Reg. 233 (09/01/17)*

##### **16 Del. Admin. Code § 4304-3.0** Mandatory elements of DMOST forms {#sec-4304-3.0 omnilex-key=us-de-regs-official--title-16--4304-3.0}

3.1 A DMOST form shall be deemed to be completed and therefore valid for the purposes of this chapter if it:

3.1.1 Contains information indicating the patient’s health care preferences;

3.1.2 Has been voluntarily signed by the patient or by another individual subscribing the patient’s name in the patient’s presence and at the patient’s express direction, or, if the patient does not have decision-making capacity, by the patient’s authorized representative;

3.1.3 Contains a statement that the DMOST form is being signed after discussion with the patient, or if the patient lacks decision-making capacity, with the patient’s authorized representative;

3.1.4 Includes the signature of the patient’s health care practitioner and the date and time of the health care practitioner’s signature;

3.1.5 If the DMOST form is not signed by the heath care practitioner in the presence of the patient, the DMOST form will also be signed by the health care provider in whose presence the patient or, the patient’s authorized representative if the patient does not have decision-making capacity, signed the DMOST form;

3.1.6 The DMOST form shall include a statement that the patient or, if the patient does not have decision-making capacity, the patient’s authorized representative, has been provided with the plain language explanation explaining the DMOST form, and the consequences of executing the DMOST form, including whether or not the DMOST form may be changed if the patient lacks decision-making capacity.

**History**
- *21 DE Reg. 233 (09/01/17)*
- *7 DE Reg. 85 (07/01/03)*
- *15 DE Reg. 211 (08/01/11)*
- *19 DE Reg. 637 (01/01/16)*
- *19 DE Reg. 922 (04/01/16)*
- *21 DE Reg. 233 (09/01/17)*
- *19 DE Reg. 922 (04/01/16)*
- *21 DE Reg. 233 (09/01/17)*

##### **16 Del. Admin. Code § 4304-4.0** Completing a DMOST form. {#sec-4304-4.0 omnilex-key=us-de-regs-official--title-16--4304-4.0}

4.1 Completing a DMOST form is always voluntary and cannot be required for any reason.

4.2 A DMOST form can only be used by a patient who is living with a serious illness or frailty whose health care practitioner would not be surprised if the patient died within the next year.

4.3 The health care practitioner must discuss the DMOST form directly with the patient, or if the patient lacks decision-making capacity, with the patient’s authorized representative, prior to completion.

4.4 A DMOST form must be signed by a health care practitioner.

4.5 Only the DMOST form in these regulations, which contains a watermark, can be recognized as a DMOST form. Copies of signed DMOST forms are legal and valid to the same extent as the original.

4.6 If any section of a DMOST form is incomplete, the full treatment described in that section shall be administered to the patient.

4.7 The patient may have decision-making capacity but be unable to communicate by speaking or writing. Federal and State laws require that a health care facility provide effective communication for people with communication impairments. In such situations:

4.7.1 The patient can make his or her health care treatment decisions known through any method by which the patient usually communicates so long as the person interpreting the communication understands the method by which the patient is communicating and the substance of the communication; and

4.7.2 The communication must be witnessed by the health care practitioner. How the communication occurred and why it is considered reliable must be documented in the patient’s medical record; and

4.7.3 If a patient cannot physically sign a DMOST form but has communicated that he or she wants to sign the DMOST form, someone other than the patient can sign the DMOST form on behalf of the patient.

4.8 Delaware law presumes an adult has decision-making capacity unless a physician determines the patient does not.

4.9 If a physician determines a patient does not have decision-making capacity, this must be documented in the patient’s medical record. If an adult patient does not have decision-making capacity, an authorized representative may sign a DMOST form on behalf of the patient if the authorized representative has the legal authority to do so.

4.9.1 The health care practitioner shall determine if there is an individual who is the patient’s authorized representative. This is determined by referencing the documentation giving such individual the required authority under law. The documentation should establish both that the authorized representative is the person named in this role and that the authorized representative has the authority to make decisions with respect to the patient's health care preferences being made on the DMOST form on behalf of the patient.

4.9.2 The hierarchy under Delaware law to act as the authorized representative for an individual without decision-making capacity is as follows:

4.9.2.1 The court-appointed Guardian, only with the appropriate authority;

4.9.2.2 The patient’s most recently appointed Agent in an Advance Health-Care Directive or Health Care Power of Attorney, only with the appropriate authority;

4.9.2.3 If the there is no Guardian or Agent or if the designated Guardian or Agent is unavailable, or if the patient revoked an Advance Health-Care Directive pursuant to 16 Del.C. §2504, the Surrogate Statute applies and will allow either the individual named by the patient prior to losing decision-making capacity or if none, the individual recognized by the Surrogate Statute, 16 Del.C. §2507, to make decisions with respect to the patient's health care preferences being made on the DMOST form on behalf of the patient.

4.10 If the patient is under age 18, and therefore has no decision-making capacity, the hierarchy under Delaware law to act as the authorized representative for such minor patient is as follows, in descending order:

4.10.1 In the absence of a court order to the contrary, the patient's biological or adoptive parents;

4.10.2 A court-appointed permanent guardian or guardian of the person under 13 Del.C. Ch. 23;

4.10.3 The Division of Family Services (DFS) with an order from a court of appropriate jurisdiction when the DFS holds legal custody or parental rights, after the DFS exercises reasonable efforts to contact and secure consent from the patient's biological or adoptive parents;

4.10.4 A caregiver acting under an Affidavit of Relative Caregiver under 13 Del.C. §§707 and 708.

**History**
- *21 DE Reg. 233 (09/01/17)*
- *7 DE Reg. 85 (07/01/03)*
- *15 DE Reg. 211 (08/01/11)*
- *19 DE Reg. 637 (01/01/16)*
- *19 DE Reg. 922 (04/01/16)*
- *21 DE Reg. 233 (09/01/17)*
- *19 DE Reg. 922 (04/01/16)*
- *21 DE Reg. 233 (09/01/17)*

##### **16 Del. Admin. Code § 4304-5.0** Modifying and Voiding Information on a Completed DMOST form {#sec-4304-5.0 omnilex-key=us-de-regs-official--title-16--4304-5.0}

5.1 Any changes or alterations to the information on the completed DMOST form voids the form.

5.2 The content of a completed DMOST form can only be modified by voiding the current DMOST form and completing a new DMOST form.

5.3 A patient with decision-making capacity may, at any time, void his or her completed DMOST form or otherwise request alternative treatment to the treatment that was ordered on the DMOST form in any manner that indicates the patient’s intent to void the DMOST form.

5.4 If a patient does not have decision-making capacity, an authorized representative may void and/or request a new DMOST form, based on the known wishes of the patient, or if unknown, the patient's best interest, if the authorized representative has the legal authority to do so and is not prohibited from doing so on the existing DMOST form completed by the patient.

**History**
- *21 DE Reg. 233 (09/01/17)*
- *7 DE Reg. 85 (07/01/03)*
- *15 DE Reg. 211 (08/01/11)*
- *19 DE Reg. 637 (01/01/16)*
- *19 DE Reg. 922 (04/01/16)*
- *21 DE Reg. 233 (09/01/17)*
- *19 DE Reg. 922 (04/01/16)*
- *21 DE Reg. 233 (09/01/17)*

##### **16 Del. Admin. Code § 4304-6.0** Field Termination {#sec-4304-6.0 omnilex-key=us-de-regs-official--title-16--4304-6.0}

Nothing in these regulations shall affect the authority of EMS providers to do the paramedic field termination of resuscitation protocol as approved by the Delaware Board of Medical Licensure and Discipline.

**History**
- *21 DE Reg. 233 (09/01/17)*
- *7 DE Reg. 85 (07/01/03)*
- *15 DE Reg. 211 (08/01/11)*
- *19 DE Reg. 637 (01/01/16)*
- *19 DE Reg. 922 (04/01/16)*
- *21 DE Reg. 233 (09/01/17)*
- *19 DE Reg. 922 (04/01/16)*
- *21 DE Reg. 233 (09/01/17)*

##### **16 Del. Admin. Code § 4304-7.0** DMOST Protocol {#sec-4304-7.0 omnilex-key=us-de-regs-official--title-16--4304-7.0}

7.1 The Division of Public Health, in consultation with the Board of Medical Licensure and Discipline and the Delaware Fire Prevention Commission, shall develop and publish a protocol for EMS providers to comply with the requirements of this regulation.

7.2 Copies of a valid DMOST form are valid to the same extent as the original.

**History**
- *21 DE Reg. 233 (09/01/17)*
- *7 DE Reg. 85 (07/01/03)*
- *15 DE Reg. 211 (08/01/11)*
- *19 DE Reg. 637 (01/01/16)*
- *19 DE Reg. 922 (04/01/16)*
- *21 DE Reg. 233 (09/01/17)*
- *19 DE Reg. 922 (04/01/16)*
- *21 DE Reg. 233 (09/01/17)*

##### **16 Del. Admin. Code § 4304-8.0** Conflicts {#sec-4304-8.0 omnilex-key=us-de-regs-official--title-16--4304-8.0}

8.1 In the event of a disagreement between the patient’s authorized representative and the patient’s health care practitioner concerning the patient's decision-making capacity or the appropriate interpretation and application of the terms of a completed DMOST form regarding the patient's course of treatment, the parties:

8.1.1 May seek to resolve the disagreement by means of procedures and practices established by the health care institution, including, but not limited to, consultation with an institutional ethics committee, or with an individual designated by the health care institution for this purpose; or

8.1.2 May seek resolution by a court of competent jurisdiction.

8.2 A health care provider involved in the patient's care or an administrator of a health care institution may seek to resolve a disagreement concerning the appropriate interpretation and application of the terms of a completed DMOST form to the patient's course of treatment in the same manner as set forth in 8.1.

8.3 In the event of conflicting directives, the patient’s scope of treatment shall be governed by the latest directive available.

8.3.1 If the treatment directives of a later Advance Health-Care Directive conflict with the patient's directives on a DMOST form, a health care practitioner shall be informed so that the DMOST form can be modified or voided in order to reflect that patient’s later directive.

8.3.2 If there is a conflict between the patient's expressed oral or written directives, the DMOST form, or the decisions of the patient’s authorized representative, the patient's last expressed oral or written directives shall be followed and, if necessary, a new DMOST form shall be prepared and executed to reflect those directives.

8.4 Any individual or entity may petition the Court of Chancery for appointment of a guardian of the person of a patient if that individual or entity has good reason to believe that the withdrawal or withholding of health care in a particular case:

8.4.1 Is contrary to the most recently expressed wishes of a patient;

8.4.2 Is predicated on an incorrect assessment of the patient’s decision-making capacity;

8.4.3 Is being proposed pursuant to a DMOST form that has been falsified, forged, or coerced;

8.4.4 Is being considered without knowledge of a voided completed DMOST form which has been unlawfully concealed, destroyed, altered, or cancelled; or

8.4.5 Is based on a patient’s status either as an individual with a pre-existing long-term mental or physical disability, or as an individual who is economically disadvantaged.

8.5 A health care institution, health care practitioner, or health care provider acting in good faith and in accordance with generally accepted health care standards applicable to the health care institution, health care practitioner, or health care provider is not subject to civil or criminal liability or to discipline for unprofessional conduct for:

8.5.1 Complying with a DMOST form signed by a health care practitioner apparently having authority to make a DMOST for a patient, including a decision to withhold or withdraw health care;

8.5.2 Declining to comply with a DMOST form based on a belief that the health care practitioner then lacked authority to sign a DMOST;

8.5.3 Complying with a DMOST form and assuming that the DMOST form was valid when made and has not been modified or voided;

8.5.4 Providing life-sustaining treatment in an emergency situation when the existence of a DMOST form is unknown; or

8.5.5 Declining to comply with a DMOST form because the DMOST form is contrary to the conscience or good faith medical judgment of the health care practitioner or the written policies of the health care institution.

**History**
- *21 DE Reg. 233 (09/01/17)*
- *7 DE Reg. 85 (07/01/03)*
- *15 DE Reg. 211 (08/01/11)*
- *19 DE Reg. 637 (01/01/16)*
- *19 DE Reg. 922 (04/01/16)*
- *21 DE Reg. 233 (09/01/17)*
- *19 DE Reg. 922 (04/01/16)*
- *21 DE Reg. 233 (09/01/17)*

##### **16 Del. Admin. Code § 4304-9.0** Data Collection/Program Evaluation {#sec-4304-9.0 omnilex-key=us-de-regs-official--title-16--4304-9.0}

9.1 The Division of Public Health shall provide appropriate information, education and training on the DMOST regulations to EMS personnel.

9.2 The Division of Public Health shall monitor the use of DMOST forms presented to EMS providers.

9.3 The Division of Public Health shall take such measures as are necessary to assure individual confidentiality.

**History**
- *21 DE Reg. 233 (09/01/17)*
- *7 DE Reg. 85 (07/01/03)*
- *15 DE Reg. 211 (08/01/11)*
- *19 DE Reg. 637 (01/01/16)*
- *19 DE Reg. 922 (04/01/16)*
- *21 DE Reg. 233 (09/01/17)*
- *19 DE Reg. 922 (04/01/16)*
- *21 DE Reg. 233 (09/01/17)*

##### **16 Del. Admin. Code § 4304-10.0** Reciprocity {#sec-4304-10.0 omnilex-key=us-de-regs-official--title-16--4304-10.0}

10.1 A DMOST form transfers with a patient and the medical orders indicated on a DMOST form are valid in every health care setting in Delaware. Copies of a valid DMOST form are valid to the same extent as the original.

10.2 A document executed in another state, which meets the requirements of this regulation for a DMOST form, the requirements of the state where such document was executed, or the state where the patient was a resident at the time the document was executed, shall be deemed to be valid for the purposes of 16 Del.C. Ch. 25A to the same extent as a DMOST form valid under that chapter.

Delaware Medical Orders for Scope of Treatment (DMOST)

DMOST is a process for documenting treatment choices.The DMOST form is voluntary. It is a portable, standardized Medical Order that will be recognized and followed by Delaware health care providers.

The DMOST conversation is an opportunity to understand the likely course of your health and medical condition, so that you may make informed choices that are appropriate and reflect what you want. If you choose, you may invite loved ones to join this conversation.

Q. What is DMOST?

A. The Delaware Medical Orders for Scope of Treatment (DMOST) form is a portable medical order form. It allows you to make choices about life-sustaining treatments, including among other treatments, CPR (resuscitation) and artificial nutrition. You may request full treatment, limited treatment, or comfort care only.

Q. Who is it for?

A. A DMOST form can be used by a person with a serious illness or frailty, whose health care practitioner would not be surprised if the person died within the next year.

Q. When should it be discussed and signed? Who signs it?

A. A DMOST form is completed after a conversation you have with a health care practitioner. It is signed by you and a physician (MD or DO), an advanced practice registered nurse (APRN), or a physician assistant (PA). The physician/APRN/PA signature makes the choices into portable medical orders.

Q. Who is required to follow the wishes documented on the DMOST form?

A. These orders will be followed by health care providers in any setting (ambulance, long-term care facility, emergency room, hospital, hospice, home, assisted living facility, etc.). It travels with you and is honored when you move to a new location.

Q. Can someone else make DMOST decisions for me?

A. You make health care decisions for yourself as long as you have decision-making capacity. You have the right to change your authorized representative at any time while you have decision-making capacity.

If a physician determines that a person lacks decision-making capacity, an authorized representative can sign a DMOST form on behalf of that person. A DMOST form does not change the decision-maker designated by an Advance Health Care Directive, a Health Care Power of Attorney document, a guardian of the person appointed by a Court, or Delaware law on health care surrogates.

If you have capacity and complete a DMOST form, you can sign on the form saying that if you lose capacity, your authorized representative cannot void the form you signed.

Q. What if I change my mind?

A. If your condition or your choices change, you or your authorized representative should void (cancel) your DMOST form and request a new DMOST be completed with your new choices. You can void a DMOST form if you change your mind but do not want to create a new one. You may not make any changes to the content of the DMOST form. If you want to change your DMOST form you must void your previous form and complete a new one with your health care practitioner. If your DMOST form does not agree with your advance directive, the most recent document will be followed.

Q. Must I do this?

A. The DMOST form is always voluntary and can be voided at any time. A health care organization is prohibited from requiring you to complete a DMOST form for any reason, including as part of a person’s admission to a health care facility.

It is important to understand that this DMOST form contains medical orders. It will be followed by health care providers. For example, if you choose “Do Not Attempt Resuscitation,” and your heart stops, no attempt will be made to restart your heart. If you choose “Intubate/Use Artificial ventilation,” then you may be placed on a breathing machine with a tube in your throat and transferred to an intensive care setting in a hospital.

Q. What will happen to my choices if I travel out of state?

A. Many states, including all the states in our region, currently use a form similar to the DMOST form. Forms from those states which are valid under the Delaware law will be honored in Delaware. DMOST forms will be honored in other states which have reciprocity.

Link to PDF of DMOST form:

https://regulations.delaware.gov/AdminCode/title16/Department of Health and Social Services/Division of Public Health/Emergency Medical Services (EMS)/4304 DMOST Form.pdf

**History**
- *21 DE Reg. 233 (09/01/17)*
- *7 DE Reg. 85 (07/01/03)*
- *15 DE Reg. 211 (08/01/11)*
- *19 DE Reg. 637 (01/01/16)*
- *19 DE Reg. 922 (04/01/16)*
- *21 DE Reg. 233 (09/01/17)*
- *19 DE Reg. 922 (04/01/16)*
- *21 DE Reg. 233 (09/01/17)*

#### **4306** Stroke System Regulation

##### **16 Del. Admin. Code § 4306-1.0** Purpose {#sec-4306-1.0 omnilex-key=us-de-regs-official--title-16--4306-1.0}

The purpose of this regulation is to establish and define the conditions under which the Delaware Statewide Stroke System functions. The goal of this Stroke System is to ensure that every person who may be experiencing a stroke in Delaware receives the same high-quality care, thus decreasing morbidity and mortality from strokes.

**History**
- *28 DE Reg. 390 (11/01/24)*

##### **16 Del. Admin. Code § 4306-2.0** Authority {#sec-4306-2.0 omnilex-key=us-de-regs-official--title-16--4306-2.0}

This regulation is promulgated pursuant to the authority of 16 Del.C. Ch. 97, Emergency Medical Services Systems and 16 Del.C. Ch.10, Hospitals.

**History**
- *28 DE Reg. 390 (11/01/24)*

##### **16 Del. Admin. Code § 4306-3.0** Organization {#sec-4306-3.0 omnilex-key=us-de-regs-official--title-16--4306-3.0}

3.1 16 Del.C. Ch. 97 legislated the creation of a state-wide stroke system of care (SSoC) in 2016 (80 Del. Laws, c. 404). The statute placed the responsibility for the system's development, implementation, and maintenance to the Office of Emergency Medical Services. The legislation authorized the Director of Public Health (DPH) to establish a standing Stroke System Committee comprised of a network of stakeholders from the stroke spectrum of care, including prevention, prehospital care, acute care, and post-acute care. Committee leadership, along with subcommittee organization and leadership, is delineated in the Stroke System of Care Policies and Procedures which are established and approved by the committee, with final approval by the Director of DPH.

3.2 Committees

3.2.1 The Stroke System of Care Coordinator serves as administrator for the Stroke System and all related committees:

3.2.2 The Stroke System of Care Committee serves as the committee providing coordination, oversight, and guidance for all components of the Stroke System in Delaware.

3.2.3 The Quality Evaluation Subcommittee serves as the subcommittee that provides recommendations, advice, and assistance to DPH in its ongoing evaluation of the Delaware Stroke System. The Committee evaluates data related to system metrics of success and quality of patient care and outcomes.

3.2.4 Ad hoc subcommittees may be assigned as needed.

**History**
- *28 DE Reg. 390 (11/01/24)*

##### **16 Del. Admin. Code § 4306-4.0** Definitions {#sec-4306-4.0 omnilex-key=us-de-regs-official--title-16--4306-4.0}

The following words and terms, when used in this regulation, have the following meaning:

"Acute Stroke Ready Hospital" or "ASRH" means a hospital or emergency center with a dedicated program for stroke care. It is the least comprehensive of the 4 stroke program certifications by The Joint Commission (TJC).

"Advanced Life Support" or "ALS" means a course of the AHA. Advanced Life Support refers to more advanced emergency medical response than Basic Life Support (BLS).

"American Heart Association" or "AHA" means a non-profit organization dedicated to fighting heart disease and stroke, including a division specifically for stroke prevention, education, and care. The American Heart Association maintains the Get With The Guidelines (GWTG) Stroke Registry.

"Basic Life Support" or "BLS" means entry-level emergency medical response as part of the prehospital triage scheme.

"Certification" means the process by which a healthcare facility petitions an organization to certify that their facility meets and maintains specified standards. For example, TJC certifies hospitals as stroke centers.

"Comprehensive Stroke Center" or "CSC" means the most extensive of TJC stroke program certifications. These centers maintain specific capabilities to be able to receive and care for the most complex stroke cases.

"Dedicated" means a resource used solely for a specific program.

"Department of Health and Social Services" or "DHSS" means a cabinet-level department that is comprised of several divisions that promote health and well-being for the citizens of Delaware.

"Designation" means a classification by which a hospital is identified by DHSS to have the appropriate resources to manage stroke patients with varying degrees of severity and is granted the authorization to function as a Delaware Stroke Center.

"Division of Public Health" or "DPH" means an agency under DHSS predominantly focused on physical health and well-being and emergency response and services.

"Emergency Medical Services" or "EMS" means the coordination of prehospital personnel, facilities, equipment, transportation, and communication to provide for the effective and coordinated delivery of medical care in emergencies resulting from accidents, illnesses, or natural disasters.

"Facility" means any location where healthcare is provided. May include stand-alone emergency departments, hospitals, skilled nursing, or rehabilitation.

"Get With the Guidelines Stroke Registry" or "GWTG" means an AHA created stroke patient registry and tool to evaluate performance indicators set by TJC.

"Hospital" means a licensed institution that provides diagnostic and therapeutic medical care. In Delaware, all stroke centers are in hospitals.

"Interfacility transfer" means the transfer of a patient from one healthcare facility to another healthcare facility.

"Large vessel occlusion" or "LVO" means the specific type of ischemic stroke where significant blockage of a major cerebral artery is present. LVOs often result in significant loss of blood flow, impact on higher level brain function, and less favorable outcomes.

"Performance improvement" means the continuous study and adaptation of the functions and processes of a healthcare organization to increase the probability of achieving desired outcomes and to better meet the needs of patients.

"Prevention" means the efforts to decrease the numbers and severity of strokes.

"Primary Stroke Centers" or "PSC" are the succeeding certification of stroke programs by TJC following ASRH. They provide critical elements such as additional diagnostics and designated bed space for stroke patients.

"Protocols" means written standards for clinical practice in a variety of situations within the Stroke System.

"Quality Evaluation Committee" or "QE Committee" means the subcommittee of the Stroke System Committee that provides recommendations, advice, and assistance to DPH in its ongoing evaluation of the Delaware Stroke System of Care. It evaluates data related to system metrics of success and quality of patient care and outcomes.

"Stroke" means a cerebrovascular accident caused by a change in blood flow that damages brain tissue. Typically caused by blood clots blocking perfusion in the brain (ischemic strokes and transient ischemic attacks) but can also be caused by non-traumatic subarachnoid or intracerebral bleeding (hemorrhagic strokes).

"Stroke System Committee" or "SSC" means the committee providing coordination, oversight, and guidance for all components of the Stroke System of Care in Delaware as established in Delaware code.

"The Joint Commission" or "TJC" means the national body that certifies or accredits various healthcare settings. The Joint Commission provides certification for stroke care centers.

"Thrombectomy-Capable Stroke Centers" or "TSC" means the third tier of TJC-certified stroke programs. In addition to the features and capabilities of ASRH and PSC, a TSC can provide endovascular procedures.

"Transfer agreement" means a formal written agreement between facilities that provides for the acceptance of patients in transfer.

"Triage" means the sorting of patients in terms of priority need for care so that appropriate treatment, transportation, and destination decisions can be made according to predetermined protocols.

"Vision, aphasia, neglect" or "VAN" means a prehospital stroke assessment tool focused on identifying LVOs. It considers motor function, visual disturbances, aphasia, and neglect (neglect evaluates senses and gaze). The assessment results in a VAN positive or VAN negative score. VAN positive indicates a high probability of an LVO.

"Verified" means successful completion of the process in which the stroke care capability and performance of an institution are evaluated by experienced on-site reviewers on behalf of TJC or other accrediting body.

**History**
- *28 DE Reg. 390 (11/01/24)*

##### **16 Del. Admin. Code § 4306-5.0** Stroke System of Care Committees and Leadership {#sec-4306-5.0 omnilex-key=us-de-regs-official--title-16--4306-5.0}

5.1 Stroke System of Care Committee and Committee Leadership Overview

5.1.1 Committees and their minimum memberships are defined within 16 Del.C. Ch. 97 Emergency Medical Services Systems and this regulation.

5.1.2 Committee leaders maintain a system-wide perspective and communicate with other committees to encourage open dialogue and system-wide problem solving.

5.1.3 Committee leaders model a collaborative approach toward Committee members and DPH/Office of Emergency Medical Services (EMS) personnel.

5.2 Leadership:

5.2.1 Presides at respective committee meetings and performs related administrative duties according to Roberts' Rules of Order;

5.2.2 Appointed by the Director of Public Health for a 3-year term and may serve subsequent terms; and

5.2.3 May serve as immediate past committee chairperson following completion of term or terms of service.

5.3 Stroke System of Care Medical Advisor:

5.3.1 Serves as an advisor on both specific and general stroke clinical and patient care issues which are brought to the Stroke System Committee or its subcommittees;

5.3.2 Assists the Stroke System Committee and its subcommittees in developing clinical-oriented system policies and protocols;

5.3.3 Serves as a leader in stroke prevention and public education activities;

5.3.4 Serves as liaison to the Stroke System Quality Evaluation Committee for medical issues requiring physician input; and

5.3.5 Is experienced in medical leadership through a previous role such as physician chairman or medical director.

5.4 Standing Committees and Subcommittees

5.4.1 The committee and subcommittees of the Stroke System of Care are as follows:

5.4.1.1 Stroke System Committee (SSC);

5.4.1.2 Stroke System Quality Evaluation Committee (QE Committee);

5.4.1.3 Stroke System Education and Prevention Subcommittee (Education Committee); and

5.4.1.4 Ad hoc subcommittees and workgroups.

5.4.2 SSC - Scope

5.4.2.1 The SSC is the overarching standing committee providing coordination, oversight, and guidance for all components of the Stroke System of Care in Delaware and is supported by the Stroke System Coordinator.

5.4.2.2 The SSC serves as an advisory committee only, providing recommendations to the DPH Director. The SSC has no regulatory, or other, authority.

5.4.2.3 The SSC and Stroke System Coordinator are responsible for the development and maintenance of the Stroke System Plan.

5.4.3 Stroke System Quality Evaluation Committee - Scope

5.4.3.1 Acts as the standing committee of the SSC that focuses on system performance improvement;

5.4.3.2 Provides recommendations, advice, and assistance to DPH in its ongoing evaluation of the Delaware Stroke System;

5.4.3.3 Evaluate statewide and hospital specific stroke data and outcomes with bench-marking against state and national performance measures.

5.4.3.4 Evaluates trend analysis of system components;

5.4.3.5 Makes recommendations for improvement actions;

5.4.3.6 Evaluates the effectiveness of actions taken and methodologies for follow-up;

5.4.3.7 Supports stroke prevention, research, and system activities by publishing or assisting others with publishing reports;

5.4.3.8 Assists with supervision of the State Stroke Registry; and

5.4.3.9 Provides administration through the State Stroke System Coordinator, in conjunction with the Stroke System QE Committee Chairperson.

5.4.4 Stroke System Education and Prevention Subcommittee (Education Committee)

5.4.4.1 Scope:

5.4.4.1.1 Acts as the standing committee of the SSC that focuses on state-wide public education, awareness, and prevention;

5.4.4.1.2 Serves as the injury-prevention component of the Delaware State Stroke System Plan;

5.4.4.1.3 Decreases death and disability from stroke through public education; and

5.4.4.1.4 Supports statewide public education and community outreach efforts.

5.4.4.2 Membership:

5.4.4.2.1 Is comprised of volunteers from agencies involved with stroke education and prevention; and

5.4.4.2.2 Unlike other stroke committees and subcommittees, leadership length of term is not defined.

5.4.5 Ad-hoc Subcommittees:

5.4.5.1 Are established as needed by the SSC Chair or Stroke System Coordinator and with approval by the SSC;

5.4.5.2 Will be comprised of volunteer membership from the SSC and defined by the ad-hoc committee's need; and

5.4.5.3 Will be led by a volunteer from the ad-hoc subcommittee with an undefined length of term.

**History**
- *28 DE Reg. 390 (11/01/24)*

##### **16 Del. Admin. Code § 4306-6.0** Delaware Stroke Center Requirements {#sec-4306-6.0 omnilex-key=us-de-regs-official--title-16--4306-6.0}

6.1 To be considered a participant in Delaware's Prehospital Stroke Triage Scheme and receive potential stroke patients from EMS and patient transport agencies, a facility must be recognized as a Delaware Stroke System of Care participating stroke center. To be recognized as an Stroke System of Care participating stroke center, the following is required:

6.1.1 Stroke certification from TJC, or equivalent nationally verified guidelines-based accrediting organization per 16 Del.C. Ch. 10.

6.1.2 Participation in 75% (3) of the quarterly SSC and Quality Evaluation Committee meetings, verified by attendance logs.

6.1.3 Submit stroke patient data to the AHA Get With The Guidelines (GWTG) Stroke Registry, no later than 90 days after the end of the quarter.

6.1.4 Agree to the sharing of performance indicator data and the use of the State of Delaware's GWTG Super User account to evaluate and improve the performance of the SSoC. The facility must maintain an acceptable standard of care for Delaware stroke patients as determined by the QE Committee and evidenced by review of GWTG stroke data.

6.1.5 Agree to provide timely patient care feedback to EMS and patient transporting agencies for the purpose of loop closure and performance improvement.

6.1.6 Enter into a Memorandum of Understanding (MOU) with the State of Delaware agreeing to these terms and requirements.

6.1.7 Be in compliance with this regulation and 16 Del.C. Ch. 97.

6.2 To be considered a participant in Delaware's Prehospital Stroke Triage Scheme and receive potential stroke patients from EMS and patient transport agencies, an out-of-state facility will receive Delaware reciprocity as a Delaware Stroke System of Care participating stroke center if the following requirements are met:

6.2.1 Stroke certification from TJC, or equivalent nationally verified guidelines-based accrediting organization.

6.2.2 Submit stroke patient data to the AHA GWTG Stroke Registry, or other similar registry/database from which data can be reported.

6.2.3 Agree to sharing of performance indicator data required by Stroke System of Care participating stroke centers, as requested by the Stroke System of Care/QE Committee.

6.3 The QE Committee chairperson may appoint a Facility Review Subcommittee to review a stroke facility's compliance with these requirements. Failure to adhere to the above requirements may result in a facility being removed from Delaware's Prehospital Stroke Triage Scheme and lose the ability to receive potential stroke patients from EMS and patient transport agencies.

**History**
- *28 DE Reg. 390 (11/01/24)*

##### **16 Del. Admin. Code § 4306-7.0** State of Delaware Triage, Transport, and Transfer Protocols {#sec-4306-7.0 omnilex-key=us-de-regs-official--title-16--4306-7.0}

7.1 Due to the dynamic nature of identification and evolution of best practices in prehospital care, the prehospital stroke triage guidance will be found solely in the current "State of Delaware, Department of Health and Social Services, DPH, Office of Emergency Medical Services, Statewide Standard Treatment Protocols, Guidelines, Policies, and Paramedic Standing Orders" and "Statewide Standard Treatment Protocols and Basic Life Support Standing Orders". The Stroke System Committee will provide input for the EMS Medical Director during the revision process of the standing orders.

7.2 For PSCs that have neurointerventional capabilities, direct routing of prehospital patients for mechanical thrombectomy evaluation may be considered by the SSoC in collaboration with the Delaware Emergency Medical Services Oversight Council (DEMSOC)/state EMS medical director, after initial and ongoing review of data, metrics, and outcomes of neurointerventional cases performed at the PSC by the QE committee to ensure that all Delaware patients are receiving the same standard of care.

7.3 Interfacility Transfer Protocol

7.3.1 Refer to the current Delaware Stroke System Guideline Interfacility Transfer Protocol, available online at https://dhss.delaware.gov/dhss/dph/ems/ems.html.

7.3.2 Rationale. The optimal outcome for the stroke patient is time dependent. It is to the patient's advantage to receive a level of medical intervention capable of providing comprehensive services for a patient's condition as promptly as possible. To perform appropriate and timely hospital-based triage, candidates for interfacility transfer must be identified quickly and the transfer process carried out promptly.

7.3.3 Formal written transfer agreements and procedures must be established and made readily available to staff before the need for their implementation.

7.3.4 As soon as the need for interfacility transfer is identified, the referring physician should initiate the transfer process by contacting the receiving facility following established transfer agreements and procedures. Care of the patient while awaiting transfer will be discussed by the referring and receiving physicians; the referring physician will continue to be responsible for treatment decisions and care of the patient until:

7.3.4.1 The patient transfer is completed by a non-hospital-based transport service; or

7.3.4.2 Care is assumed by the receiving hospital's transport team.

7.3.5 The most appropriate, available mode of interfacility transportation is determined by the referring physician, with consideration of operational factors as well as clinical needs arriving at the best decision at the time of transfer request.

7.3.6 Stroke patients who are to be transferred to another facility must be transported to a Delaware-recognized stroke center or a stroke center verified by TJC (or other nationally verified guidelines-based accrediting body such as Det Norske Veritas (DNV), according to the guidelines in subsections 7.3.6.1 through 7.3.6.4. These guidelines are adapted from the following American Heart Association (AHA) guidelines with additional review and recommendations of the Stroke System Committee:

7.3.6.1 Guidelines for the Early Management of Patients With Acute Ischemic Stroke (2019).

7.3.6.2 Recommendations for the Establishment of Stroke Systems of Care (2019).

7.3.6.3 Guidelines for Management of Patients With Spontaneous Intracerebral Hemorrhage (2022).

7.3.6.4 Guidelines for Management of Patients With Aneurysmal Subarachnoid Hemorrhage (2023).

7.3.7 Acute ischemic stroke patients requiring inter-facility transfer for neurointerventional evaluation for mechanical thrombectomy will go to the closest nationally certified and Delaware-recognized TSC or CSC.

7.3.7.1 If the closest TSC or CSC is located outside the state of Delaware, the receiving facility will be determined by the transferring facility based upon availability of transport teams, differences in transport times, and patient/family requests, with preference given to treating Delaware stroke patients within the state of Delaware if feasible without significant delays in care.

7.3.7.2 Out of state facilities treating Delaware stroke patients will be required to submit their endovascular data, metrics, and outcomes as requested by the QE Committee, and as is required of facilities performing mechanical thrombectomy within the state of Delaware. If this condition is not met, the SSoC may consider removal of that facility as a Delaware-recognized stroke center.

7.3.7.3 If a stroke patient needing evaluation for mechanical thrombectomy arrives at a facility that does not have neurointerventional capabilities, and another hospital within the same health system does have neurointerventional capabilities but is not TSC or CSC certified, transfer to that hospital may be considered based upon availability of resources, transport times, and patient/family requests. These hospitals will be held to the conditions stated in subsection 7.3.7.2 of this regulation to ensure that all Delaware patients are receiving the same standard of care.

7.3.7.4 Acute ischemic stroke patients without suspected LVO requiring inter-facility transfer for additional stroke evaluation or care, or post-thrombolytic care, due to unavailable resources at their current facility, will go to a nationally certified and Delaware-recognized PSC, TSC, or CSC.

7.3.7.5 Hemorrhagic stroke patients (non-traumatic intracerebral hemorrhage or subarachnoid hemorrhage) requiring interfacility transfer for neurosurgical, neuro critical care, neurointerventional evaluation due to unavailable resources at their current facility, will go to a Delaware-recognized or nationally certified CSC.

7.3.8 Documentation. Full documentation of the patient's course, including initial and subsequent assessment findings, treatment, and results of diagnostic studies including copies of CT scans, MRI (if available), and x-rays whenever possible should be uploaded or forwarded to the receiving hospital with or before the arrival of the patient.

7.3.9 Quality Management. All transfers to or from Delaware recognized stroke centers will be reviewed for both the stroke center and Stroke System quality management processes.

7.4 Follow-up and closed-loop closure. It is the responsibility of the receiving hospital to provide timely feedback to EMS and the transferring facility (as applicable) on the status and outcome of each patient received.

7.5 The Delaware Stroke System of Care QE Committee chairperson may appoint a Facility Review Subcommittee to review a stroke facility's compliance with these requirements. Failure to adhere to the above requirements may result in a facility being removed from Delaware's Prehospital Stroke Triage Scheme and lose the ability to receive potential stroke patients from EMS and patient transport agencies.

**History**
- *28 DE Reg. 390 (11/01/24)*

##### **16 Del. Admin. Code § 4306-8.0** State of Delaware Stroke System Performance Improvement Plan {#sec-4306-8.0 omnilex-key=us-de-regs-official--title-16--4306-8.0}

8.1 Purpose. The State of Delaware Stroke System is committed to the provision of optimal care for all injured persons. To attain this goal, DPH coordinates all medical services provided to stroke patients based on national standards for stroke care as set forth by TJC, Disease-Specific Care Certification Review Process Guide, 2022, and subsequent revisions and the American Heart Association's Get With The Guidelines Stroke Registry. This Performance Improvement Plan seeks to "improv[e] stroke care by promoting consistent adherence to the latest scientific treatment guidelines, [as evidenced by] numerous published studies demonstrating the program's success in achieving measurable patient outcome improvements." (https://www.heart.org/en/professional/quality-improvement/get-with-the-guidelines/get-with-the-guidelines-stroke)

8.2 Objectives

8.2.1 Based on national standards for stroke care quality improvement outlined in TJC's Disease-Specific Care Certification Review Process Guide, 2022, and subsequent revisions, the Stroke System's Performance Improvement Plan describes the framework for use in designing, measuring, assessing, and improving the Delaware Stroke System's organization, functions, and services.

8.2.2 The plan promotes performance improvement through education, facilitation of inter-hospital and intra-hospital communication, and systems coordination. It integrates all prehospital, medical staff, nursing, ancillary services, and operational performance improvement activities through systematic monitoring and evaluation of the appropriateness of patient care, the measurement of outcomes, and the identification of opportunities for improvement.

8.2.3 Improvement is accomplished by a collaborative approach with the appropriate facilities, services, and disciplines involved, utilizing the following objectives:

8.2.3.1 Continual systematic measurement to understand and maintain the stability of systems and processes;

8.2.3.2 Measurement of patient and systems outcomes to help determine priorities for improving systems and processes; and

8.2.3.3 Assessment of system competence and performance.

8.3 Authority

8.3.1 The care of the stroke patient is monitored and evaluated at both the facility and System levels. DPH has the authority for system data collection, review, and most importantly the authority to recommend corrective action in all aspects of stroke care throughout the continuum from onset to rehabilitation. DPH will guide, as needed, individual stroke centers in the development and implementation of their Stroke Performance Improvement Programs.

8.3.2 Maintenance of patient confidentiality is the joint responsibility of evaluators at the State and facility levels.

8.4 Prehospital Evaluation

8.4.1 Objective

8.4.1.1 DPH shall work with the Fire Prevention Commission to address improvements regarding prehospital care of the stroke patient. The AHA's GWTG and the current "State of Delaware, Department of Health and Social Services, DPH, Office of Emergency Medical Services, Statewide Standard Treatment Protocols, Guidelines, Policies, and Paramedic Standing Orders" and "Statewide Standard Treatment Protocols and Basic Life Support Standing Orders" will provide a basis for prehospital stroke care evaluation.

8.4.1.2 Evaluation

8.4.1.2.1 There will be an ongoing evaluation of all aspects of stroke care from the receipt of the call at central dispatch through the patient's care at the stroke center.

8.4.1.2.2 Evaluation will document the quality of care provided and compliance with protocols. Areas in need of improvement will be identified. Major areas of review are as follows:

8.4.1.2.2.1 Completion of assessment with VAN/electrocardiogram/blood glucose/Last Known Well which is hours elapsed since a patient was known to be at their baseline, without signs and symptoms of their current stroke activity;

8.4.1.2.2.2 Scene time;

8.4.1.2.2.3 Transport decisions;

8.4.1.2.2.4 Transport to the appropriate facility;

8.4.1.2.2.5 Under/over triage with VAN;

8.4.1.2.2.6 Documentation; and

8.4.1.2.2.7 Data collection.

8.4.2 Delaware will follow national standards for prehospital data collection. DPH will collaborate with the State Fire Prevention Commission to determine the minimum data sets to be collected by BLS and ALS providers. Data used for the evaluation of prehospital care must be consistent with the design of the Delaware Stroke Registry, as collected by the medical facilities and analyzed by DPH.

8.4.3 Performance improvement indicators will be determined by the Stroke System QE Committee based on Delaware prehospital protocols and national and Delaware standards of care.

8.4.4 Performance Improvement

8.4.4.1 A completed prehospital patient care record must be provided to the receiving facility for inclusion in the patient's emergency room or hospital medical record. Facilities and prehospital providers are strongly encouraged to establish a mechanism for the exchange of information, including the provision of feedback to prehospital providers on triage decisions made. Additionally, the hospital's stroke registrar will include this record's data in the facility's stroke registry for outcome evaluation.

8.4.4.2 A performance improvement program model shall be developed by DPH or its designee for the use of BLS and ALS agencies. Recommendations for changes in educational curricula, patient care protocols, etc., shall be based on analysis of information obtained through the prehospital evaluation process. DPH shall also develop a mechanism for prehospital providers to have input into quality assurance issues, including the identification of educational needs and methods of addressing them.

8.5 Stroke Center Evaluation

8.5.1 All recognized stroke facilities will design a performance improvement plan that meets the standards and requirements established by TJC or other nationally recognized accreditation body. Hospital performance improvement plans will be verified during site surveys and quality improvement visits.

8.5.2 Design. When new processes or systems are developed within an institution, the design will be based on the following:

8.5.2.1 Up-to-date sources of information about designing processes and systems including practice guidelines, clinical pathways, professional standards, and regulatory standards;

8.5.2.2 The needs and expectations of internal and external consumers; and

8.5.2.3 The performance of the processes and systems and their outcomes including internal and external (benchmarking) comparison data.

8.5.3 Measure. Quality indicators (audit filters) will be based on nationally recognized guidelines set forth by TJC. They are established to evaluate the process or outcome of the care or services provided or to determine the level of performance of existing processes and the outcomes resulting from these processes. Data collection and measurement will be systematic, related to relevant standards of care, and prioritized according to high volume, high risk, or problem-prone areas. In addition, the needs, expectations, and feedback from patients and their families, employees, results of ongoing monitoring activities (e.g., infection control), safety of the patient care environment, utilization, and risk management findings will be included.

8.5.4 Data collection will be designed to:

8.5.4.1 Assess new or existing processes;

8.5.4.2 Measure the level of performance and stability of important existing processes;

8.5.4.3 Set performance improvement priorities;

8.5.4.4 Establish benchmarks of performance to identify potential opportunities for improvement;

8.5.4.5 Identify patterns and trends that may require focused attention;

8.5.4.6 Provide comparative performance data to use for performance improvements; and

8.5.4.7 Evaluate whether changes have improved the processes.

8.5.5 Quality indicators (audit filters) may:

8.5.5.1 Measure events or phenomena that are expected to occur at some level of frequency:

8.5.5.2 Relate data about either a process or an outcome;

8.5.5.3 Relate data about occurrences that are either desirable or undesirable;

8.5.5.4 Relate data that guide the Stroke Program in improving norms of performance instead of focusing exclusively on censoring or eliminating individual outliers; and

8.5.5.5 Identify serious events that may trigger an opportunity for improvement and require further data collection.

8.5.6 Focused audits will be used to periodically examine the process of care as recommended by TJC and may include the following:

8.5.6.1 Noncompliance with hospital criteria for stroke center designation

8.5.6.2 The absence of documentation of required information/patient assessment findings on stroke care records

8.5.7 Assessment

8.5.7.1 After collection, the data will be analyzed to determine the following:

8.5.7.1.1 If the design specifications for new processes were met;

8.5.7.1.2 The level of performance and stability of existing processes;

8.5.7.1.3 Priorities for possible improvement of existing processes;

8.5.7.1.4 Actions and strategies to improve the performance of processes; and

8.5.7.1.5 Whether changes in the processes resulted in improvement.

8.5.7.2 This assessment will be accomplished using statistical quality control techniques and tools, comparative benchmarking data (TJC, GWTG, and others), a review of the stroke program's processes and outcomes over time, and other reference material as appropriate. Intensive assessment will be used when measurement indicates that potential performance or system-related opportunities for improvement exist, a single serious event occurs, the control limits are met, or when undesirable variation in performance has occurred or is occurring.

8.5.7.3 The assessment process will be interdisciplinary and interdepartmental depending upon the process or outcome under review.

8.5.8 Improvement. When an opportunity for improvement is identified or when the measurement of an existing process identifies the need to redesign a process, a systematic approach such as the Find, Organize, Clarify, Understand, Select and Plan, Do, Check, Act (FOCUS-PDCA) Six Sigma Model, will be implemented. This model is the ongoing process used to promote continuous improvement as described below:

8.5.8.1 Find (Identify) process to improve.

8.5.8.1.1 Develop an opportunity statement; and

8.5.8.1.2 Identify the process.

8.5.8.2 Organize a team that knows the process.

8.5.8.2.1 Identify employees who work closest with the process; and

8.5.8.2.2 Identify internal/external consumers and their expectations.

8.5.8.3 Clarify current knowledge of the process.

8.5.8.3.1 Identify sound areas of the process;

8.5.8.3.2 Determine if team members are appropriate to assess the process;

8.5.8.3.3 Identify the process flow; and

8.5.8.3.4 Identify problems/redundancies that can be eliminated to make the flow more efficient.

8.5.8.4 Understand the cause of process variation.

8.5.8.4.1 Identify variation in the process;

8.5.8.4.2 Identify measurable process characteristics;

8.5.8.4.3 Identify if the variation has a common or unique cause; and

8.5.8.4.4 Identify the effect the variation has on other hospital systems.

8.5.8.5 Select an improvement strategy.

8.5.8.5.1 Determine what changes can be made to improve the process; and

8.5.8.5.2 Start a description of the process to be improved.

8.5.8.6 Plan the improvement and data collection

8.5.8.6.1 Identify what improvements are to be made and in what order;

8.5.8.6.2 Assign responsibility for making the change;

8.5.8.6.3 Determine when the change will be effective; and

8.5.8.6.4 Determine what data will be collected to measure changes.

8.5.8.7 Do (put plan into action) the Improvement.

8.5.8.7.1 Initiate the change (pilot study period); and

8.5.8.7.2 Collect data.

8.5.8.8 Check the results.

8.5.8.8.1 Analyze the results of the data collection; and

8.5.8.8.2 Draw conclusions.

8.5.8.9 Act to sustain gains

8.5.8.9.1 Standardize the change;

8.5.8.9.2 Determine ongoing measurement of the process and reevaluation of implemented changes (effectiveness monitored for a minimum of 3 months following corrective action);

8.5.8.9.3 Policy and procedure development/revision; and

8.5.8.9.4 Education and communication of new process.

8.5.9 Following the identification and documentation of a specific problem in patient care or system performance by the peer-review process, corrective action is taken through 1 of the following mechanisms:

8.5.9.1 Change existing policies and procedures that govern or define the standard of care.

8.5.9.2 Provide professional education. Cases may be selected for discussion at the stroke service conferences; deficits in knowledge can be addressed through education of the whole group of providers or specific providers.

8.5.9.3 Provide counseling. Specific cases are reviewed by the Director of Stroke, chief of the service, or the supervisor, with the individual.

8.5.9.4 Provide credentials. Report information from quality improvement activities through the institution's performance improvement system for consideration at the time of credentialing, delineation of privileges, or evaluation.

8.6 Stroke System Evaluation

8.6.1 Stroke System evaluation encompasses the entire scope of care provided to stroke patients within the State of Delaware from stroke onset through rehabilitation.

8.6.2 DPH Responsibilities

8.6.2.1 Implement and monitor the State Stroke System Quality Improvement Program; and

8.6.2.2 Appoint a qualified Stroke System Medical Advisor and SSC Chairperson from candidates recommended by the SSC members. Terms of Service:

8.6.2.2.1 Terms of office are 3 years, and

8.6.2.2.2 Successive terms are permissible.

8.6.3 Stroke System Registry Coordinator Responsibilities

8.6.3.1 Review Stroke Registry data submitted for completeness.

8.6.3.2 Provide data for the QE Committee meetings, upon request.

8.6.3.3 Complete approved data requests from GWTG.

8.6.3.4 Function as staff for QE Committee.

8.6.4 Delaware State Stroke System QE Committee

8.6.4.1 The Stroke System QE Committee is a subcommittee of the Stroke System Committee.

8.6.4.2 Membership consists of representatives from each component of the statewide Stroke System.

8.6.4.3 Responsibilities of the QE Committee

8.6.4.3.1 The Delaware Stroke System QE Committee is charged with providing recommendations, guidance, and technical assistance to DPH in its ongoing evaluation of the Delaware Stroke System. Specific functions may include the following:

8.6.4.3.1.1 Assist the Stroke System Registry Coordinator in the supervision of the State Stroke Registry.

8.6.4.3.1.2 Assess stroke care standards and recommend actions for the development and implementation of statewide policies and procedures that guide and support the provision of stroke care or services.

8.6.4.3.1.3 Assess resources needed to support and sustain the Delaware State Stroke System.

8.6.4.3.1.4 Evaluate the coordination and integration of prehospital, inter-hospital, intra-hospital, and ancillary services.

8.6.4.3.1.5 Monitor the incidence of adverse outcomes regularly with comparison to regional and national norms.

8.6.4.3.1.6 Recommend action for identified problems or opportunities for improvement in patient care services.

8.6.4.3.1.7 Sponsor ongoing education regarding TJC and GWTG standards and provide a multidisciplinary educational forum for presentation and discussion of interesting, difficult, or controversial stroke patient management cases.

8.6.4.3.1.8 Evaluate the effectiveness of actions taken and determine follow-up.

8.6.4.3.1.9 Meet a minimum of 4 times per year, and as determined by the Committee or DPH.

8.6.4.3.1.10 Assess other sources of data to combine into a comprehensive database for evaluation of the continuum of stroke care in the State of Delaware.

8.6.4.3.1.11 Develop operational guidelines for the Committee's functioning.

8.6.4.3.1.12 Perform any other function deemed necessary by DPH.

8.6.4.3.2 Review of major areas within the Stroke System, including:

8.6.4.3.2.1 Triage;

8.6.4.3.2.2 Interfacility transfer;

8.6.4.3.2.3 Facility performance;

8.6.4.3.2.4 Impact of system;

8.6.4.3.2.5 Integrity of Stroke Registry data; and

8.6.4.3.2.6 Prevention trends.

8.7 Delaware State Stroke Registry

8.7.1 Patient Criteria. To generate consistent statewide data, all patients with an International Classification of Diseases (ICD) code included in TJC reporting requirements must be included in the stroke registry (GWTG).

8.7.2 Data Set

8.7.2.1 Facilities will abstract the required data as soon as possible, but no more than 90 days after the close of each quarter.

8.7.2.2 Data collected from contributing acute care facilities will form the State's stroke patient registry. System registry data will then be used in the process of formulating System reports, and for System quality improvement, data linkage, and research/prevention activities.

8.7.2.3 The Delaware State Stroke Registry data set is defined by GWTG.

8.7.3 Hospital Participation

8.7.3.1 All acute care facilities in Delaware that receive stroke patients will be required to contribute to the State stroke registry program by abstracting data into GWTG.

8.7.3.2 Each contributing facility will be responsible for the staff and resources to ensure timely and accurate stroke data abstraction.

8.7.3.3 Both the individual contributing facilities and the State will be responsible for data integrity and confidentiality.

8.8 Oversight. The Emergency Medical Services Office within DPH receives at least semi-annual reports of the Stroke System's Evaluation Committee activities. Minutes of each meeting will be forwarded to the System of Care Coordinator in a timely manner.

8.9 Confidentiality. As used in this section, "records" means the recordings of interviews and all oral or written reports, statements, minutes, memoranda, charts, data, statistics, and other documentation generated by the Evaluation Committee, its subcommittees, and the State Stroke Registry for the stated purpose of stroke system medical review or quality care review and audit.

8.9.1 All quality management proceedings shall be confidential. Records of the State Stroke Evaluation Committee, its subcommittees, the Delaware State Stroke Registry, and attendees at meetings held for stated purposes of stroke system medical review or quality care review and audit shall be confidential and privileged and shall be protected from direct or indirect means of discovery, subpoena, or admission into evidence in any judicial or administrative proceeding.

8.9.2 All studies, reports, and minutes will include only the patient stroke registry number with all other identifying information encoded or kept in locked files. Access to qualified researchers may be granted based on state, federal, and municipal statutes, bylaws, rules, regulations, and policies. All meeting attendees will be required to sign confidentiality statements. Any documented breach of confidentiality will be referred to DPH for appropriate action.

8.10 Biennial Review. This plan is reviewed at least biennially by DPH and the QE Committee.

**History**
- *28 DE Reg. 390 (11/01/24)*

##### **16 Del. Admin. Code § 4306-9.0** Effective Date {#sec-4306-9.0 omnilex-key=us-de-regs-official--title-16--4306-9.0}

This regulation shall become effective 90 days after the date of publication of the final implementing order in the Delaware Register of Regulations.

**History**
- *28 DE Reg. 390 (11/01/24)*

#### **4400** Health Systems Protection (HSP)

#### **4447** Regulations Governing the Sanitation of Migratory Agricultural Labor Housing Camps and Field Sanitation (Hand Labor) Operations

##### **16 Del. Admin. Code § 4447-1.0** General Provisions {#sec-4447-1.0 omnilex-key=us-de-regs-official--title-16--4447-1.0}

1.1 Preamble

1.1.1 The Secretary of Delaware Health and Social Services adopts these Regulations pursuant to the authority vested by 16 Del.C. §122(3) a, b, c, e, g and j. These Regulations, as amended, provide a system of permitting, inspecting and enforcing migratory agricultural labor housing camps and field sanitation/hand labor operation.

1.1.2 These Regulations are adopted on (Month Day Year) and have an effective date of (Month Day Year).

1.2 Purpose and Scope

1.2.1 The purpose of these Regulations is to provide minimum standards for design, construction, maintenance and operation of migratory agricultural labor housing camps and field sanitation/hand labor operation in the State of Delaware, and to assure a clean, healthful, and safe environment for agricultural workers and their families using these camps and facilities.

1.2.2 These Regulations in no way preclude a facility from establishing additional rules and operating procedures that do not contradict those established herein.

1.3 Variance

1.3.1 The Division may grant a variance by modifying or waiving the requirements of these Regulations if, in the opinion of the Division, a health hazard or nuisance will not result from the variance.

1.3.2 A variance shall not be transferable from person to person, or from location to location.

1.3.3 If a variance is granted, the Division shall retain the information specified below in its records for the camp or field sanitation/hand labor operation:

1.3.3.1 A statement of the proposed variance of the requirement of these Regulations, citing the relevant section of these Regulations;

1.3.3.2 An analysis of the rationale for how the potential public health hazard or nuisance will be alternatively addressed by the proposal; and

1.3.3.3 Any other information requested by the Division that may be deemed necessary to render the judgment.

1.3.4 A variance, if granted, is rendered void upon occurrence one or more of the following: the physical facility is demolished; a remodeling project in the facility includes the area addressed in the variance; or the permit holder granted the variance ceases to operate the camp or field sanitation/hand labor operation for a period exceeding 30 consecutive days.

1.4 Severability

1.4.1 In the event any particular clause or section of the Regulations should be declared invalid or unconstitutional by a court of competent jurisdiction, the remaining portions shall remain in full force and effect.

**History**
- *15 DE Reg. 521 (10/01/11)*

##### **16 Del. Admin. Code § 4447-2.0** Definitions {#sec-4447-2.0 omnilex-key=us-de-regs-official--title-16--4447-2.0}

For the purposes of these Regulations the following definitions shall apply:

“Agricultural Employer” means any person, corporation, association, or other legal entity that: owns or operates an agricultural establishment; contracts with the owner or operator of an agricultural establishment in advance of production for the purchase of a crop and exercises substantial control over production; or recruits and supervises employees or is responsible for the management and condition of an agricultural establishment.

“Agricultural establishment” means a business operation that uses paid employees in the production or handling of food, fiber, or other materials such as seed, seedlings, plants, or parts of plants.

“Director” means the Director of the Delaware Division of Public Health or his/her designee.

“Division” means the Delaware Division of Public Health as the agency, and its authorized representative, having jurisdiction to promulgate, monitor, administer and enforce these Regulations.

“Field Sanitation Operation” means any agricultural establishment where 11 or more employees are engaged on any given day in hand-labor operations in the field for more than three (3) consecutive hours.

“Hand Labor Operation” means agricultural activities or agricultural operations performed by hand or with hand tools. Hand labor operations also include other activities or operations performed in conjunction with hand labor in the field. Some examples of hand labor operations are the hand-cultivation, hand-weeding, hand-planting and hand-harvesting of vegetables, nuts, fruits, seedlings or other crops, including mushrooms, and the hand packing of produce into containers, whether done on the ground, on a moving machine, or in a temporary packing shed located in the field. Hand-labor does not include such activities as logging operations, the care or feeding of livestock, or hand-labor operations in permanent structures (e.g., canning facilities or packing houses).

“Handler” means any person (except a common or contract carrier of produce owned by another person) who handles produce, including a producer who handles produce of his own production.

“Handwashing facility” means a facility providing a basin, container or outlet with an adequate supply of potable water, soap and single-use towels. Moist towelettes cannot be substituted for soap and water.

“Imminent Health Hazard” means a condition that presents a hazard to the health of a migrant agricultural worker or the worker’s family that includes but is not limited to any one of the following:

“Migratory Agricultural Labor Housing and Camp” or “Camp” means one or more buildings, structures, trailers, or mobile homes, together with the tract of land pertaining thereto, established, operated or maintained, or used as living quarters for five (5) or more migrant agricultural workers. No tents shall be accepted as living quarters.

“Migratory Agricultural Labor Housing and Camp Operator” or “Camp Operator” means the person who has been granted a permit to operate a migratory agricultural labor camp or the person who arranges or provides housing for migratory agricultural workers.

“Migrant agricultural worker” means an individual who is employed in agricultural employment of a seasonal or temporary nature, and who is required to be absent overnight from his permanent place of residence.

“Permit” means written approval by the Division to operate a camp or field sanitation/hand labor operation. Approval is given in accordance with these Regulations and is separate from any other licensing requirement that may exist within communities or political subdivisions comprising the jurisdiction.

“Person” means an individual, corporation, business trust, estate trust, partnership, limited liability company, association, joint venture, or any other legal or commercial entity.

“Person in Charge” means the owner of the camp or field sanitation/hand labor operation. This individual shall represent the camp at any hearing scheduled pursuant to Section 7.0 of these Regulations. Every migratory agricultural labor housing camps and field sanitation/hand labor operation shall, upon request, provide the Division with the name of their person(s) in charge and how the person in charge can be contacted. A camp operator, hired by the camp owner, cannot be the person in charge.

“Potable Water” means water which is in compliance with all of the required applicable drinking water regulations.

“Shelter” means any building, structure, trailer or mobile home of one or more rooms used for sleeping or living quarters.

“Toilet Facility” means a fixed or portable facility designed for the purpose of adequate collection and containment of the products of both defecation and urination which is applied with toilet paper adequate to employee needs. Toilet facility includes biological, chemical, flush and combustion toilets.

**History**
- *15 DE Reg. 521 (10/01/11)*

##### **16 Del. Admin. Code § 4447-3.0** Preoperational Requirements {#sec-4447-3.0 omnilex-key=us-de-regs-official--title-16--4447-3.0}

3.1 Permits

3.1.1 No person shall operate a migratory agricultural labor housing camp or field sanitation/hand labor operation who does not have a valid permit issued by the Division. Only a person who complies with the requirements of these Regulations shall be entitled to receive or retain a permit.

3.1.2 A valid permit shall be posted in a location easily observed by workers and families.

3.1.3 A permit shall not be transferable from person to person or from location to location.

3.1.4 When a camp or field sanitation/hand labor operation changes ownership, management firm, or lessee, a new permit is required. Both the facility and its operation shall be brought into full compliance with these regulations and the Delaware Building Code prior to the issuance of a permit. A variance may be issued as provided by these Regulations.

3.1.5 When there is new construction or renovations after the adoption of these Regulations, both the facility and its operation shall be brought into full compliance with these Regulations and the Delaware Building Code prior to the issuance of a permit.

3.1.6 Camps that are lawfully in existence and operating at the time of adoption of these regulations shall be permitted to have their use and maintenance continued if the use, maintenance or repair of the physical facility and structure is in accordance with the original design and no hazard to life or health is created by the existing camp.

3.2 Classification of Operational Permits

3.2.1 Annual Permit – a permit issued to a camp or field sanitation/hand labor operation that is in compliance with these Regulations. An annual permit is valid for one calendar year.

3.2.2 Provisional Permit – a permit issued to a camp or field sanitation/hand labor operation that is not in complete compliance with these Regulations. When no health hazards are present in an existing camp or field sanitation/hand labor operation, as determined by the Division, and the owner or operator demonstrates proof of intention to correct, within a specified time period, those items which do not meet permit requirements, a provisional permit may be issued. Plans, as required, and a written statement delineating changes to be made and completion dates must be presented to the Division before a provisional permit shall be issued. A provisional permit is valid for a 30-day period, with possible extension to a maximum of 60 days, and shall be non-renewable. After satisfactory compliance with provisional permit requirements, an annual permit shall be issued.

3.3 Issuance of Permits

3.3.1 Any person desiring to operate a camp or field sanitation/hand labor operation shall make written application for a permit on forms provided by the Division. Such application shall include the name and address of the owner, the location and type of the proposed camp or field sanitation/hand labor operation and the signature of each applicant. The application shall be made at least 30 days prior to the proposed date of arrival of the migrant agricultural workers.

3.3.2 Prior to approval of an application for a permit, the Division shall inspect the proposed camp or field sanitation/hand labor operation to determine compliance with the requirements of these Regulations.

3.3.3 The Division shall issue a permit to the applicant if its inspection reveals that the proposed camp or field sanitation/hand labor operation complies with the requirements of these Regulations.

3.4 Submission of Plans

3.4.1 Whenever a camp or field sanitation/hand labor operation is constructed or undergoes physical alterations, or whenever an existing structure is converted to a camp or field sanitation/hand labor operation, properly prepared plans and specifications for such construction, alteration or conversion shall be submitted to the Division for review and approval before construction, alteration or conversion begins. The Division shall approve plans and specifications if they meet the requirements of these Regulations.

**History**
- *15 DE Reg. 521 (10/01/11)*

##### **16 Del. Admin. Code § 4447-4.0** Inspections {#sec-4447-4.0 omnilex-key=us-de-regs-official--title-16--4447-4.0}

4.1 Prior to issuance of a permit, the Division shall inspect the proposed camp or field sanitation/hand labor operation to determine compliance with the requirements of these Regulations.

4.2 Representatives of the Division, after proper identification, shall be permitted to enter a camp or field sanitation/hand labor operation at any reasonable time for the purpose of making inspections to determine compliance with these Regulations. These inspections may include any area associated with the camp or field sanitation/hand labor operation.

4.3 Representatives of the Division shall be permitted to examine the records of any camp or field sanitation/hand labor operation to obtain information pertaining to the camp or operation.

4.4 The Director may, after providing the opportunity for a hearing, suspend the permit of a camp or field sanitation/hand labor operation for a period not to exceed 90 days, for refusing access to representatives of the Division.

**History**
- *15 DE Reg. 521 (10/01/11)*

##### **16 Del. Admin. Code § 4447-5.0** General Sanitation – Camps {#sec-4447-5.0 omnilex-key=us-de-regs-official--title-16--4447-5.0}

5.1 Sites

5.1.1 Sites used for camps shall be adequately drained. They shall not be subject to periodic flooding, nor located within 200 feet of swamps, pools, sink holes, or other surface collections of water unless such quiescent water surfaces can be subjected to mosquito control measures. The camp shall be located so the drainage from and through the camp will not endanger any domestic or public water supply. All sites shall be graded, ditched, and rendered free from depressions in which water may become a nuisance.

5.1.2 Sites shall be adequate in size to prevent overcrowding of necessary structures. The principal camp area in which food is prepared and served and where sleeping quarters are located shall be at least 500 feet from any area in which livestock is kept.

5.1.3 The grounds and open areas surrounding the shelters shall be maintained in a clean and sanitary condition free from rubbish, debris, waste paper, garbage, or other refuse.

5.1.4 An adequate number of yard lights shall be provided in the main area including the laundry, shower and toilet areas.

5.2 Shelter

5.2.1 Every shelter in the camp shall be constructed in a manner which will provide protection against the elements.

5.2.2 Each room used for sleeping purposes shall contain at least 50 square feet of floor space for each occupant. At least a 7-foot ceiling shall be provided.

5.2.3 Beds, cots, or bunks, and suitable storage facilities such as wall lockers for clothing and personal articles, shall be provided in every room used for sleeping purposes.

5.2.3.1 Beds, cots, bunks and storage facilities shall be spaced not closer than 36 inches both laterally and end to end, and shall be elevated at least 12 inches from the floor.

5.2.3.2 If double-deck bunks are used, they shall be spaced not less than 48 inches both laterally and end to end. The minimum clear space between the lower and upper bunk shall be not less than 27 inches.

5.2.3.3 Triple-deck bunks are prohibited.

5.2.4 The floors of each shelter shall be constructed of wood, asphalt, or concrete. Wooden floors shall be of smooth and tight construction. The floors shall be kept in good repair.

5.2.4.1 All wooden floors shall be elevated not less than one (1) foot above the ground level at all points to prevent dampness and to permit free circulation of air beneath.

5.2.5 All living quarters shall be provided with windows the total of which shall be not less than one-tenth of the floor area. At least one-half of each window shall be so constructed that it can be opened for purposes of ventilation.

5.2.6 All exterior openings shall be effectively screened with 16-mesh material. All screen doors shall be equipped with self-closing devices.

5.2.7 In a room where workers cook, live, and sleep a minimum of 100 square feet per person shall be provided. Sanitary facilities shall be provided for storing and preparing food.

5.2.8 In camps where cooking facilities are used in common, stoves shall be provided in an enclosed and screened shelter. Sanitary facilities shall be provided for storing and preparing food.

5.2.9 All heating, cooking, and water heating equipment shall be installed in accordance with State and local laws. If a camp is used during cold weather, adequate heating equipment shall be provided.

5.3 Water supply

5.3.1 An adequate and convenient water supply, approved by the State of Delaware, shall be provided in each camp for drinking, cooking, bathing, and laundry purposes.

5.3.2 A water supply shall be deemed adequate if it is capable of delivering 35 gallons per person per day to the campsite at a peak rate of 2.5 times the average hourly demand.

5.3.3 The distribution lines shall be capable of supplying water at normal operating pressures to all fixtures for simultaneous operation. Water outlets shall be distributed throughout the camp in such a manner that no shelter is more than 100 feet from a yard hydrant if water is not piped to the shelters.

5.3.4 Where water under pressure is available, one or more drinking fountains shall be provided for each 100 occupants or fraction thereof. Common drinking cups are prohibited.

5.4 Toilet facilities

5.4.1 Toilet facilities adequate for the capacity of the camp shall be provided.

5.4.2 Each toilet room shall be located so as to be accessible without any individual passing through any sleeping room. Toilet rooms shall have a window not less than 6 square feet in area opening directly to the outside area or otherwise be satisfactorily ventilated. All outside openings shall be screened with 16-mesh material. No fixture, water closet, chemical toilet, or urinal shall be located in a room used for other than toilet purposes.

5.4.3 A toilet room shall be located within 200 feet of the door of each sleeping room.

5.4.4 Where the toilet rooms are shared, such as in multifamily shelters and in barracks type facilities, separate toilet rooms shall be provided for each sex. These rooms shall be distinctly marked "for men" and "for women" by signs printed in English and in the native language of the persons occupying the camp, or marked with easily understood pictures or symbols. If the facilities for each sex are in the same building, they shall be separated by solid walls or partitions extending from the floor to the roof or ceiling.

5.4.5 Where toilet facilities are shared, the number of water closets or chemical toilets provided for each sex shall be based on the maximum number of persons of that sex which the camp is designed to house at any one time, in the ratio of one such unit to each 15 persons, with a minimum of two units for any shared facility.

5.4.6 Urinals shall be provided on the basis of one unit or 2 linear feet of urinal trough for each 25 men. The floor, from the wall and for a distance not less than 15 inches measured from the outward edge of the urinals, shall be constructed of materials impervious to moisture. Urinals shall be provided with adequate water flush.

5.4.7 Every water closet installed on or after August 31, 1971, shall be located in a toilet room.

5.4.8 Each toilet room shall be lighted naturally or artificially by a safe type of lighting at all hours of the day and night.

5.4.9 An adequate supply of toilet paper shall be provided in each water closet or chemical toilet compartment.

5.4.10 Toilet rooms shall be kept in a sanitary condition and cleaned at least daily.

5.5 Sewage disposal facilities

5.5.1 All sewer lines and floor drains from buildings shall be connected to a sewage disposal system approved by the Delaware Department of Natural Resources and Environmental Control.

5.6 Laundry, handwashing, and bathing facilities

5.6.1 Laundry, handwashing, and bathing facilities shall be provided as per the applicable Delaware Building and Plumbing codes and in the following ratio:

5.6.1.1 One handwash basin per family shelter or per six persons in shared facilities.

5.6.1.2 One shower head for every 10 persons.

5.6.1.3 One laundry tray or tub for every 30 persons.

5.6.1.4 One slop sink in each building used for laundry, hand washing, and bathing.

5.6.2 Floors shall be of smooth finish but not slippery materials; they shall be impervious to moisture. Floor drains shall be provided in all shower baths, shower rooms, or laundry rooms to remove waste water and facilitate cleaning. All junctions of the curbing and the floor shall be covered. The walls and partitions of shower rooms shall be smooth and impervious to the height of splash – six (6) feet. Partitions are required between women’s showers.

5.6.3 An adequate supply of hot and cold running water shall be provided for bathing and laundry purposes. Facilities for heating water shall be provided.

5.6.4 Every service building shall be provided with equipment capable of maintaining a temperature of at least 68° F during cold weather.

5.6.5 Facilities for drying clothes shall be provided.

5.6.6 All service buildings shall be kept clean.

5.7 Lighting

5.7.1 Each habitable room in a camp shall be provided with at least one ceiling-type light fixture and at least one separate floor or wall-type convenience outlet.

5.7.2 Laundry and toilet rooms and rooms where people congregate shall contain at least one ceiling or wall-type fixture.

5.7.3 Light levels in toilet and storage rooms shall be at least 20 foot-candles 30 inches from the floor.

5.7.4 Other rooms, including kitchens and living quarters, shall have light levels of at least 30 foot-candles 30 inches from the floor.

5.8 Refuse disposal

5.8.1 Fly-tight, rodent-tight, impervious, cleanable or single service containers, approved by the Division, shall be provided for the storage of garbage. At least one such container shall be provided for each family shelter and shall be located within 100 feet of each shelter on a wooden, metal, or concrete stand.

5.8.2 Garbage containers shall be kept clean.

5.8.3 Garbage containers shall be emptied when full, but not less than twice a week.

5.9 Construction and operation of kitchens, dining hall, and feeding facilities

5.9.1 In all camps where central dining or multiple family feeding operations are permitted or provided, the food handling facilities shall be provided with the following:

5.9.1.1 Stoves or hot plates, with a minimum equivalent of two burners, in a ratio of 1 stove or hot plate to 10 persons, or 1 stove or hot plate to 2 families in a screened enclosure.

5.9.1.2 Adequate food storage shelves and counter space for food preparation.

5.9.1.3 Mechanical refrigeration for food at a temperature of not more than 41° F.

5.9.1.4 Tables and chairs, or equivalent seating, adequate for the intended use of the facility provided at a rate to seat one-half of the camp’s population.

5.9.1.5 Adequate facilities for washing, rinsing and sanitizing dishes and utensils. This will include, at a minimum, a three compartment sink with proper disposal of the liquid waste.

5.9.1.6 Adequate lighting and ventilation.

5.9.1.7 Floors made of non-absorbent, easily cleaned materials.

5.9.2 A properly constructed kitchen and dining hall adequate in size, separate from the sleeping quarters of any of the workers or their families, shall be provided in connection with all food handling facilities. There shall be no direct opening from living or sleeping quarters into a kitchen or dining hall.

5.9.3 No person with any communicable disease shall be employed or permitted to prepare, cook, serve, or otherwise handle food, foodstuffs, or materials used therein, in any kitchen or dining room operated in connection with a camp or regularly used by persons living in a camp.

5.10 Control of Animals, Rodents, Insects and Other Vermin

5.10.1 Approved methods shall be used for the elimination and control of animals, rodents, insects or other vermin.

5.11 First aid

5.11.1 Adequate first aid facilities shall be maintained and made available in every camp for the emergency treatment of injured persons.

5.11.2 A first aid kit shall be supplied by the camp operator, and shall be located in an easily accessible place and available for immediate use.

5.12 Reporting communicable disease

5.12.1 It shall be the duty of the camp operator to report immediately to the Division the name and address of any individual in the camp known to have or suspected of having a communicable disease.

5.12.2 Whenever there shall occur in any camp a case of suspected food poisoning or an unusual prevalence of any illness in which fever, diarrhea, sore throat, vomiting, or jaundice is a prominent symptom, it shall be the duty of the camp operator to report immediately the existence of the outbreak to the Division by telephone, electronic mail or any method that is equally fast.

**History**
- *15 DE Reg. 521 (10/01/11)*

##### **16 Del. Admin. Code § 4447-6.0** General Sanitation – Field Sanitation/Hand Labor Operations {#sec-4447-6.0 omnilex-key=us-de-regs-official--title-16--4447-6.0}

Agricultural employers shall provide the following for employees engaged in field sanitation/hand labor operations, without cost to the employee:

6.1 Potable drinking water.

6.1.1 Potable water shall be provided and placed in locations readily accessible to all employees.

6.1.2 Water shall be suitably cool and in sufficient amounts, taking into account the air temperature, humidity and the nature of the work performed, to meet the needs of all employees.

6.1.3 Water shall be dispensed in single-use drinking cups or by fountains. The use of common drinking cups or dippers is prohibited.

6.2 Toilet and handwashing facilities.

6.2.1 One toilet facility and one handwashing facility shall be provided for every 20 employees or fraction thereof.

6.2.2 Toilet facilities shall be adequately ventilated, appropriately screened, have self-closing doors that can be closed and latched from the inside, and shall be constructed to insure privacy.

6.2.3 Toilet and handwashing facilities shall be accessibly located in close proximity to each other. The facilities shall be located within a one-quarter-mile walk of each hand laborer's place of work in the field.

6.2.4 Where due to terrain it is not feasible to locate facilities as required above, the facilities shall be located at the point closest vehicular access.

6.2.5 Toilet and handwashing facilities are not required for employees who perform field work for a period of three (3) hours or less, including transportation time to and from the field, during the day.

6.3 Maintenance. Potable drinking water and toilet and handwashing facilities shall be maintained in accordance with the following:

6.3.1 Drinking water containers shall be constructed of materials that maintain water quality, shall be refilled daily or more often as necessary, shall be kept covered, and shall be regularly cleaned.

6.3.2 Toilet facilities shall be operational and maintained in clean and sanitary condition.

6.3.3 Handwashing facilities shall be refilled with potable water as necessary to ensure an adequate supply and shall be maintained in a clean and sanitary condition; and

6.3.4 Disposal of wastes from facilities shall not cause unsanitary conditions.

6.4 Reasonable use.

6.4.1 The agricultural employer shall notify each employee of the location of the sanitation facilities and water and shall allow each employee reasonable opportunities during the workday to use them. The agricultural employer shall also inform each employee of the importance of following good hygiene practices to minimize exposure to the hazards in the fields of heat, communicable diseases, retention of urine, and agrichemical residues.

**History**
- *15 DE Reg. 521 (10/01/11)*

##### **16 Del. Admin. Code § 4447-7.0** Compliance Procedures {#sec-4447-7.0 omnilex-key=us-de-regs-official--title-16--4447-7.0}

7.1 General. When an inspection reveals that the camp or field sanitation/hand labor operation is not in compliance with these Regulations, the permit holder shall take corrective action within the time specified by the Division. The permit holder may additionally be required to provide to the Division a written plan to correct violations of the Regulations, including the method of correction and the anticipated date of completion.

7.2 Administrative Action

7.2.1 Operating without a permit

7.2.1.1 If a camp or field sanitation/hand labor operation is found operating without a valid permit, the Division shall order immediate closure. The closure shall be effective upon written notice to the person in charge of the establishment. The establishment shall remain closed until proper application, submission and review of plans, and inspection reveals compliance with these Regulations and approval for permit is made.

7.2.1.2 A conspicuous, colored placard shall be prominently displayed at all entrances of the camp or field sanitation/hand labor operation which has failed to obtain a valid permit.

7.2.2 Imminent Health Hazard

7.2.2.1 Suspension of Permit

7.2.2.1.1 If a condition is determined to exist in a migratory agricultural labor housing camp or field sanitation/hand labor operation that represent an imminent health hazard, the Division may suspend the operating permit of the camp or field sanitation/hand labor operation without a hearing or written notice for a period not to exceed ten (10) days.

7.2.2.1.2 The suspension shall be effective upon receipt of written notice by the person in charge of the camp or field sanitation/hand labor operation. A suspension statement recorded on the inspection report by the inspecting Division representative constitutes a written notice. The person in charge shall be requested to yield the permit to the representative of the Division. The Director shall be notified of the suspension by the close of the following business day. The permit shall not be suspended for a period longer than ten (10) days without a hearing.

7.2.2.1.3 The owner/operator of a camp or field sanitation/hand labor operation may request, in writing, a hearing before the Director at any time during the period of suspension, for the purpose of demonstrating that the imminent health hazard no longer exists. The request for hearing shall not stay the suspension.

7.2.2.1.4 If a follow-up inspection by a representative of the Division shows that the immediate health hazard or the imminent health hazard no longer exists, the suspension shall be lifted immediately and the permit returned.

7.2.2.3 Hearing. If the imminent health hazard is not eliminated, the Division shall schedule an administrative hearing within the ten (10) day period of suspension. The purpose of the hearing is to determine if the suspension should be extended, the permit revoked or other action taken. Failure to hold a hearing within the ten (10) day period shall automatically terminate the suspension.

7.2.2.4 A conspicuous, colored placard shall be prominently displayed at all entrances of a migratory agricultural labor housing camp or field sanitation/hand labor operation whose permit stands suspended or revoked for an imminent health hazard.

7.2.3 Serious Violations, Repeat Violations and General Unsanitary Conditions

7.2.3.1 Suspension of Permit. If serious violations, repeat violations, or general unsanitary conditions exist, the Division may issue and properly serve due notice, by certified mail or by hand delivery, of the intention of the Division to suspend the permit of a migratory agricultural labor housing camp or field sanitation/hand labor operation. The Division shall not suspend a permit of a migratory agricultural labor housing camp or field sanitation/hand labor operation for serious or repeated violations that do not present an imminent health hazard, without having first issued and properly served such notice of intent to suspend.

7.2.3.2 Hearing. Within 30 days of the date of such notice of intent to suspend, the permit holder may submit to the Division a written request for an administrative hearing. The suspension shall commence upon expiration of the notice of intent, unless within 30 days of the date of such notice, the Division receives from the permit holder a written request for an administrative hearing. If the permit holder makes a timely request for an administrative hearing, the suspension shall be stayed pending the results of the hearing.

7.2.3.2 A conspicuous, colored placard shall be prominently displayed at all entrances of a migratory agricultural labor housing camp or field sanitation/hand labor operation whose permit has been suspended or revoked for serious violations, repeat violations or general unsanitary conditions.

7.3 Administrative Hearing

7.3.1 Upon due notice that the Division intends to suspend the permit of a camp or field sanitation/hand labor operation, the permit holder may submit to the Division, within 30 days of the date of such notice of intent, a written request for an administrative hearing.

7.3.2 When an administrative hearing is scheduled, the permit holder of the camp or field sanitation/hand labor operation, shall be informed at least five (5) days prior to the hearing of the place, time, and date of the hearing and the specific charges against the camp or field sanitation/hand labor operation. Notification of the hearing shall be by certified mail or by hand delivery.

7.3.3 Failure of the permit holder to be present for an administrative hearing shall result in automatic suspension of permit and recommendation for revocation.

7.4 Records of Administrative Proceedings

7.4.1 A written report of the hearing decision shall be furnished by the Division to the permit holder of the camp or field sanitation/hand labor operation.

7.5 Additional Penalties

7.5.1 Any person who neglects or fails to comply with the requirements of these Regulations shall be subject to the provisions of 16 Del.C. §107, and shall be fined not less than $100 and not more than $1,000, together with costs, unless otherwise provided by law.

7.5.2 The Division may seek to enjoin violations of these Regulations

**History**
- *15 DE Reg. 521 (10/01/11)*

#### **4452** Clean Indoor Air Act

##### **16 Del. Admin. Code § 4452-1.0** Preamble {#sec-4452-1.0 omnilex-key=us-de-regs-official--title-16--4452-1.0}

These regulations are adopted in accordance with authority vested in the Secretary, Department of Health and Social Services, by 16 Del.C. §2906(b). These regulations establish standards for the enforcement of the Clean Indoor Air Act as it relates to most indoor enclosed areas to which the general public is invited or in which the general public is permitted. Regulations establishing standards for the enforcement of the Clean Indoor Air Act affecting employers, employees and the workplace are adopted by the Department of Labor.

**History**
- *23 DE Reg. 213 (09/01/19)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*
- *23 DE Reg. 213 (09/01/19)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*
- *23 DE Reg. 213 (09/01/19)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*
- *6 DE Reg. 655 (11/01/02)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*

##### **16 Del. Admin. Code § 4452-2.0** Purpose {#sec-4452-2.0 omnilex-key=us-de-regs-official--title-16--4452-2.0}

These regulations shall be construed and applied to protect the nonsmoker from involuntary exposure to environmental tobacco smoke and emissions produced by electronic smoking devices in most enclosed indoor areas to which the public is invited or in which the general public is permitted. The purpose of the Clean Indoor Air Act is to preserve and improve the health, comfort and environment of the people of this State by limiting exposure to tobacco smoke and emissions produced by electronic smoking devices.

**History**
- *23 DE Reg. 213 (09/01/19)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*
- *23 DE Reg. 213 (09/01/19)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*
- *23 DE Reg. 213 (09/01/19)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*
- *6 DE Reg. 655 (11/01/02)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*

##### **16 Del. Admin. Code § 4452-3.0** Severability {#sec-4452-3.0 omnilex-key=us-de-regs-official--title-16--4452-3.0}

In the event any particular clause or section of the regulations should be declared invalid or unconstitutional by any court of competent jurisdiction, the remaining portions shall remain in full force and effect.

**History**
- *23 DE Reg. 213 (09/01/19)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*
- *23 DE Reg. 213 (09/01/19)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*
- *23 DE Reg. 213 (09/01/19)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*
- *6 DE Reg. 655 (11/01/02)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*

##### **16 Del. Admin. Code § 4452-4.0** Inspections {#sec-4452-4.0 omnilex-key=us-de-regs-official--title-16--4452-4.0}

The Secretary, DHSS, or authorized designee shall have right of entry into any enclosed indoor area subject to 16 Del.C. Ch. 29.

**History**
- *23 DE Reg. 213 (09/01/19)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*
- *23 DE Reg. 213 (09/01/19)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*
- *23 DE Reg. 213 (09/01/19)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*
- *6 DE Reg. 655 (11/01/02)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*

##### **16 Del. Admin. Code § 4452-5.0** Waiver {#sec-4452-5.0 omnilex-key=us-de-regs-official--title-16--4452-5.0}

The Department of Health and Social Services may upon written request waive the provisions of these regulations if the Department determines there are compelling reasons to do so, and such waiver will not significantly affect the health and comfort of non-consumers of tobacco products.

**History**
- *23 DE Reg. 213 (09/01/19)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*
- *23 DE Reg. 213 (09/01/19)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*
- *23 DE Reg. 213 (09/01/19)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*
- *6 DE Reg. 655 (11/01/02)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*

##### **16 Del. Admin. Code § 4452-6.0** Definitions {#sec-4452-6.0 omnilex-key=us-de-regs-official--title-16--4452-6.0}

6.1 The following words, terms, and phrases, when used in these regulations, shall have the meaning ascribed to them in this section, except where the context clearly indicates a different meaning.

6.2 For the purposes of these regulations:

“Department” means the Delaware Department of Health and Social Services (DHSS) as defined in Title 29 Del.C. §7901.

“Electronic Smoking Device” means any product containing or delivering nicotine or any other similar substance intended for human consumption that can be used by a person to simulate smoking through inhalation of vapor aerosol from the product. The term includes any such device, whether manufactured, distributed, marketed, or sold as an e-cigarette, e-cigar, e-pipe, e-hookah, or vape pen, or under any other product name or descriptor.

“Environmental Tobacco Smoke” (ETS), or "Secondhand Smoke" means the complex mixture formed from the escaping smoke of a burning tobacco product (termed as sidestream smoke) and smoke exhaled by the smoker. Exposure to ETS is also frequently referred to as "passive smoking" or "involuntary smoking."

“Enclosed Indoor Area” means an indoor area that is neither open nor partially enclosed except for normal means of access and egress through doors or passageways.

“Fraternal Benefit Society” means any incorporated society, order or supreme lodge, without capital stock, including one exempted under the provisions of 18 Del.C. §6237(a)(2) of this title, whether incorporated or not, conducted solely for the benefit of its members and their beneficiaries and not for profit, operated on a lodge system with ritualistic form of work, having a representative form of government and which provides benefits in accordance with this chapter.

“Private Club” means any club or organization that does not permit the general public to access its facilities or activities. Access is denied to anyone who does not agree or adhere to the rules of membership. In order to be considered a private club or organization for purposes of the Clean Indoor Air Act, the establishment must adhere to all of, but not limited to, the following criteria:

a. Have a permanent mechanism to carefully screen applicants for membership on subjective rather than objective factors;

b. Limits access and use of facilities, services and activities of the organization to members and guests of the members;

c. Is controlled by its membership and operates solely for the benefit and pleasure of its members;

d. Advertises exclusively and only to its members, excluding membership drives.

“Private Social Function” means a function to which the public is neither invited nor generally permitted access and which is held in separate indoor enclosed indoor area.

“Public Transportation of Children” means transportation that involves the transportation of children by a vehicle under the control of a daycare, school or other organizations.

“Secretary” means the Administrator of the Delaware Department of Health and Social Services (DHSS) of the State of Delaware, who shall hereafter in this document be referred to as: Secretary; The Secretary; or, Secretary, DHSS.

“Smoking” means the burning of a lighted cigarette, cigar, pipe or any other matter or substance that contains tobacco; or, the use of an electronic smoking device which creates an aerosol or vapor, or in any manner or in any form.

“Vapor Establishment” means a business that: 1) generates at least 80% of its revenue from the sale of electronic smoking devices and substances for use within electronic smoking devices; and 2) does not share indoor common space with other businesses unless there are doors from the vapor establishment to the indoor common space that remain closed other than for ingress and egress.

“Volunteer Fire Company” means a fire, ambulance, or rescue company recognized as such by the Delaware State Fire Prevention Commission.

**History**
- *23 DE Reg. 213 (09/01/19)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*
- *23 DE Reg. 213 (09/01/19)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*
- *23 DE Reg. 213 (09/01/19)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*
- *6 DE Reg. 655 (11/01/02)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*

##### **16 Del. Admin. Code § 4452-7.0** Smoking Prohibitions {#sec-4452-7.0 omnilex-key=us-de-regs-official--title-16--4452-7.0}

7.1 Except as is provided in subsection 8.1 of these regulations, and in order to reduce the levels of exposure to environmental tobacco smoke and emissions produced by electronic smoking devices, smoking shall not be permitted and no person shall smoke in any of the following areas:

7.1.1 Any enclosed indoor area, including, but not limited to, those listed in 16 Del.C. §2903, to which the general public is invited or in which the general public is permitted. This shall apply to any organization, business or establishment that caters to or offers goods or services or facilities to, or solicits patronage from the general public.

7.1.2 Government owned and/or operated means of mass transportation including buses, vans, trains, taxicabs and limousines.

7.1.3 Functions or activities of private clubs or organizations, as defined by Section 6.0 of these regulations, when access by the general public is allowed or solicited.

7.1.4 Any private vehicle used for the public transportation of children or as part of health care or day care transportation.

7.1.5 In private homes or private residences when such homes or residences are being used for child care or day care.

7.2 No owner of any indoor enclosed area subject to 16 Del.C. Ch. 29 and/or person(s) responsible for the management of such area or employee thereof shall permit or authorize smoking by any person(s) in areas not designated specifically for the smoking of tobacco products as permitted by subsection 8.1.

7.3 Vapor Establishments

7.3.1 Vapor establishments are permitted to have emissions produced by electronic smoking devices within their places of businesses.

7.3.2 Any vapor establishment permitted to have emissions produced by electronic smoking devices in such establishment pursuant to these regulations, and which permits such emissions, shall prohibit anyone under the age of 21 from entering.

**History**
- *23 DE Reg. 213 (09/01/19)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*
- *23 DE Reg. 213 (09/01/19)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*
- *23 DE Reg. 213 (09/01/19)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*
- *6 DE Reg. 655 (11/01/02)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*

##### **16 Del. Admin. Code § 4452-8.0** Smoking Prohibitions Inapplicable {#sec-4452-8.0 omnilex-key=us-de-regs-official--title-16--4452-8.0}

8.1 Smoking prohibitions shall not apply in the following:

8.1.1 Private homes, private residences and private automobiles;

8.1.2 Any indoor area where private social functions are being held when seating arrangements are under the control of the sponsor of the function and not the owner, operator, manager or person in charge of such indoor area;

8.1.3 Limousines under private hire;

8.1.4 A hotel or motel room rented to 1 or more guests provided that the total percentage of such hotel or motel rooms does not exceed twenty-five percent (25%);

8.1.5 Any fund raising activity or function sponsored by a volunteer fire company, auxiliary of a fire company, or a volunteer ambulance or volunteer rescue company; provided, however, that the fund raising activity or function takes place upon property owned or leased by the volunteer fire, rescue or ambulance company;

8.1.6 Any fund raising activity or function sponsored by a fraternal benefit society as defined by 18 Del.C. §6201; provided, however, that the fund raising activity or function takes place upon property owned or leased by said organization; and

8.1.7 Any enclosed indoor area operated or in use exclusively by a private club as defined in these regulations.

**History**
- *23 DE Reg. 213 (09/01/19)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*
- *23 DE Reg. 213 (09/01/19)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*
- *23 DE Reg. 213 (09/01/19)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*
- *6 DE Reg. 655 (11/01/02)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*

##### **16 Del. Admin. Code § 4452-9.0** Posting of Signs {#sec-4452-9.0 omnilex-key=us-de-regs-official--title-16--4452-9.0}

9.1 Failure to Properly Post and Maintain Signs

9.1.1 Owners, operators, managers or other person(s) having control of enclosed indoor areas subject to the regulations of 16 Del.C. Ch. 29 shall post signs which indicate “Warning: Smoking Permitted” prominently to indicate those locations where smoking is permitted pursuant to subsection 8.1. Failure to prominently post properly maintained signs with letters at least one (1) inch in height and in accord with the CLEAN INDOOR AIR ACT shall be a violation subject to administrative penalties as set forth in subsection 10.1 of the Clean Indoor Air Act Regulations.

9.1.2 Any vapor establishment permitted to have emissions produced by electronic smoking devices in such establishment pursuant to these regulations, and which permits such emissions, shall display a sign at all entrances stating that no one under the age of 21 is allowed in such a vapor shop. Failure to prominently post at all entrances properly maintained signs with letters at least one (1) inch in height shall be a violation subject to administrative penalties as set forth in subsection 10.1 of the Clean Indoor Air Act Regulations.

**History**
- *23 DE Reg. 213 (09/01/19)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*
- *23 DE Reg. 213 (09/01/19)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*
- *23 DE Reg. 213 (09/01/19)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*
- *6 DE Reg. 655 (11/01/02)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*

##### **16 Del. Admin. Code § 4452-10.0** Compliance and Enforcement Procedures {#sec-4452-10.0 omnilex-key=us-de-regs-official--title-16--4452-10.0}

10.1 Administrative Penalties. Whoever violates any provision of these regulations shall be subject to an administrative penalty of $100.00 for the first violation and not less than $250.00 for each subsequent violation.

10.2 Right to Administrative Hearing. Upon due notice that the Department intends to assess an administrative penalty, as indicated in subsection 10.1, the entity may submit to the Division, within thirty (30) days of the date of such notice of intent, a written request for an administrative hearing.

10.3 Orders of the Department. Whoever refuses, fails or neglects to perform the duties required under these regulations or violates, neglects or fails to comply with the duly adopted regulations or orders of the Dept. of Health and Social Services, shall be fined not less than $100.00 and not more than $1,000.00, together with cost, unless otherwise provided by law.

**History**
- *23 DE Reg. 213 (09/01/19)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*
- *23 DE Reg. 213 (09/01/19)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*
- *23 DE Reg. 213 (09/01/19)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*
- *6 DE Reg. 655 (11/01/02)*
- *19 DE Reg. 407 (11/01/15)*
- *23 DE Reg. 213 (09/01/19)*

#### **4455** Delaware Regulations Governing a Detailed Plumbing Code

##### **16 Del. Admin. Code § 4455-1.0** State of Delaware Plumbing Code {#sec-4455-1.0 omnilex-key=us-de-regs-official--title-16--4455-1.0}

The Delaware Division of Public Health shall hereby adopt the 2021 International Plumbing Code with following amendments. The code shall be known as the "2021 State of Delaware Plumbing Code". Every political subdivision within the State, including county, city, or municipal governments, shall enforce the International Plumbing Code (IPC) as adopted or modified by the Division of Public Health. Local jurisdictions may have additional water, wastewater and administrative requirements that are not part of this code. The 2021 IPC is available at ICCSAFE.ORG. The Delaware amendments are available at:

https://regulations.delaware.gov/AdminCode/title16/Department%20of%20Health%20and%20Social%20Services/Division%20of%20Public%20Health/Health%20Systems%20Protection%20(HSP)/4455.shtml

Plumbing program information and documents are available at:

http://www.dhss.delaware.gov/dhss/dph/hsp/plumbing.html

**History**
- *9 DE Reg. 786 (11/01/05)*
- *14 DE Reg. 813 (02/01/11)*
- *15 DE Reg. 1724 (06/01/12)*
- *19 DE Reg. 138 (08/01/15)*
- *23 DE Reg. 384 (11/01/19)*
- *26 DE Reg. 110 (08/01/22)*

##### **16 Del. Admin. Code § 4455-2.0** Adoption of International Plumbing Code {#sec-4455-2.0 omnilex-key=us-de-regs-official--title-16--4455-2.0}

The State of Delaware Plumbing Code adopts, as if fully set forth herein, "The International Plumbing Code 2021" as amended herein:

2.1 Amend Subsection 101.1 by inserting "The 2018 Delaware Plumbing Code" in NAME OF JURISDICTION.

2.2 Amend Subsection 101.2 by deleting the subsection in its entirety and by inserting in lieu thereof the following: "The provisions of this Code shall apply to the erection, installation, alteration, repair, and relocation, and replacement, addition to, use or maintenance of plumbing systems within the State of Delaware."

2.3 Amend Subsection 102.2 by deleting the subsection in its entirety and by inserting in lieu thereof the following: "The legal use and occupancy of any structure existing on the effective date of this Code, or for which it had been heretofore approved, may be continued without change.

Exception: Upon change of permit holder in facilities and operations regulated by the Delaware Division of Public Health such systems shall comply with the requirements of this Code and applicable regulations promulgated and standards established by the Delaware Division of Public Health."

2.4 Add new Subsection 102.8.3 to read "ICC codes referenced in the Delaware Plumbing Code shall be enforced by jurisdictions adopting said codes."

2.5 Amend Subsection 106.1 by adding a new sentence at the end of the paragraph to read as follows: "The Division of Public Health shall issue plumbing permits and a $100 fee shall be assessed for all plumbing permits issued by the Division of Public Health. Apartments and condominiums shall be charged $100.00 per each individual unit. Local jurisdictions set their own fee schedule. A $50.00 re-inspection fee is charged to any job requiring more than 3 inspections, which will be implemented six months after the effective date of this regulation. Commercial permit applications require an approval to construct document from the Division of Public Health prior to the issuance of plumbing permits unless otherwise waived by the code official or plan review office in accordance with subsection 106.3.1."

2.5.1 Amend Subsection 106.2 by adding thereto three new numbered paragraphs following numbered paragraph "2" to read as follows: "3. No permit or fee is required by the Division of Public Health for the replacement of an existing fixture, piece of equipment or related piping, including but not limited to hot water heaters and water conditioning systems. 4. The relocation of any plumbing fixture and related pipe requires a permit. 5. Any new fixture, piece of equipment, backflow prevention assembly or system that connects to the potable water supply shall require a permit and shall meet the provisions of this Code."

2.5.2 Amend Subsection 106.5.3 by deleting this subsection in its entirety and replacing it with the following: "No permit shall be issued by the Division of Public Health for the same work on an active permit without cause unless the permit holder relinquishes said permit or the permit expires or there is no work on the permit for a period exceeding 6 months or otherwise is canceled by the code official for cause. An active permit issued by the Division of Public Health is valid for 1 year".

2.5.3 Amend Subsection 106.6.3 by adding thereto a new numbered paragraph following paragraph "3" to read as follows: "4. The Division of Public Health does not refund plumbing permit fees."

2.6 Amend Subsection 107.2 by adding the following: "4. The Division of Public Health has 3 working days to respond to an inspection request."

2.6.1 Amend Subsection 107.2 by adding the following: "4. Each permit is allowed 3 inspections, including improper work, incomplete work, and inaccessible installations. Subsequent re-inspections are charged a $50.00 fee for service by the Delaware Division of Public Health, which will be implemented six months after the effective date of this regulation. Local jurisdictions have their own fee schedules. Reinspection fees are due in 30 days. New permits will not be issued if reinspection fees are not paid in 30 days."

2.7 Amend Subsection 108.1 by deleting the subsection in its entirety and by inserting in lieu thereof the following: "It shall be unlawful for any person to work as a master plumber in the State of Delaware unless such person has received a license from the Delaware Department of State, Division of Professional Regulation, showing that said person has been duly licensed as a master plumber, except as provided by Title 24, Section 1807(c) of the Delaware Code, and has a permit issued by the Delaware Division of Public Health or local jurisdiction. Master Plumbers shall display their DE master plumber license number on all company vehicles. The lettering shall be 3 inches high and shall be of a contrasting color of the vehicle to which it is affixed.

Exception: The homeowner of a single-family residence occupied, or to be occupied by the homeowner for not less than 1 year and not for sale, rent or lease, may perform plumbing work only on such residence itself or auxiliary structures, and in compliance with a permit issued by the Delaware Division of Public Health, or applicable authority, and in compliance with all provisions of these regulations."

2.7.1 Amend Subsection 108.2 by adding the following: 1. Underground plumbing covered before an inspection takes place must be uncovered unless compliance may otherwise be determined. 2. Rough-in plumbing covered before an inspection takes place will have to be uncovered unless compliance may otherwise be determined. 3. An inspection request for final inspection only must accompany a record of underground and rough-in inspections unless otherwise approved.

2.8 Amend Subsection 108.4 by deleting the subsection in its entirety and by inserting in lieu thereof the following: "Any person who shall violate any provisions of this Code, or shall fail to comply with the requirements thereof, or who shall install plumbing work in violation of an approved plan or directive of the Code Official or the plumbing inspector(s), or of a permit or certificate issued under the provisions of this Code, shall be subject to penalties as provided by Title 16, Chapter 79 of the Delaware Code or penalties of the local jurisdiction."

2.8.1 Amend Subsection 108.5 by deleting the words: "shall be liable to a fine of not less than [AMOUNT] dollars or more than [AMOUNT] dollars" as it appears therein and inserting in lieu thereof the following: "shall be subject to penalties as provided by Title 16, Chapters 1 and 79 of the Delaware Code or penalties of the local jurisdiction."

2.9 Amend Section 109 by deleting the section in its entirety and replacing it with the following: "Any person shall have the right to appeal a decision of the code official to the Division of Public Health in accordance to law or to the local jurisdiction where a permit is issued."

2.10 Section 202 General Definitions

2.10.1 Amend Section 202 by adding thereto a new definition after the definition "Manifold" to read as follows: "Master Plumber. A person who has complied with the provisions of the Delaware Division of Professional Regulation and the Board of Plumbing Examiners, and has further met the certification, testing, bonding, and licensing requirements of the jurisdiction in which he/she plans to engage in the business of plumbing. A master plumber shall be recognized as being responsible for all work performed under a plumbing permit issued by the Delaware Division of Public Health or local jurisdiction."

2.10.2 Amend Section 202 by adding a new definition after the definition of approved agency to read as follows: "Approved heat transfer fitting. A metal threaded fitting that transitions between the relief valve and the relief valve discharge pipe that is listed in table 605.4."

2.10.3 Amend Section 202 by adding thereto a new definition after the definition "Soil Pipe" and before the definition "Spill proof Vacuum Breaker" to read as follows: "Solvent cement. The sealant used to connect pipes and fittings. This Code prohibits the use of all-purpose glue in any reference to solvent cement unless it conforms to the required ASTM standards."

2.10.4 Amend Section 202 by adding thereto a new definition after the definition "Sump Vent" and before the definition "Supports" to read as follows: "Supervision of Work. Work completed under the permit of a master plumber while employed by the master plumber, or the same firm, partnership, corporation, or owners of the company as the master plumber."

2.10.5 Amend Section 202 by amending the definition of "Building Drain" by deleting the phrase "30 inches (762 mm)" and replacing it with the words "5 feet".

2.10.6 Amend Section 202 by adding "The Director of the Delaware Division of Public Health or their designee" to the definition of “Code Official”.

2.11 Amend Subsection 305.4.1 by deleting the subsection in its entirety.

2.12 Amend Section 312 by adding thereto a new subsection 312.5.1 to read as follows: "In lieu of the presence of the plumbing inspector witnessing the test, the master plumber may certify in writing upon a prescribed form that the plumbing system piping is in accordance with Section 312 of these regulations. Local jurisdictions may require the test to be witnessed by the plumbing inspector."

2.12.1 Amend Subsection 312.5 by adding the following: "The Division of Public Health may utilize self-certification forms for inspections and fixtures."

2.12.2 Amend Subsection 312.10.2 by adding a new sentence after the last sentence to read: "The Division of Public Health Plumbing Program inspects initial installations of a backflow assembly but does not conduct, track, or enforce subsequent tests or inspections. Local jurisdictions may have additional requirements. Owners of backflow assemblies are required to test backflow assemblies at least annually and must make testing certifications available or provide through an asse certified vendor upon request of the Division of Public Health or local jurisdiction.

2.13 Amend Table 403.1 by deleting subscript e and replacing it with the following: "Mercantile occupancies in malls must have at least one service sink within 300 ft."; and by deleting subscript f and replacing it with the following: "Public pool plumbing fixtures are regulated by the Delaware Regulations Governing Public Pools."

2.13.1 Amend Table 403.1.2 by replacing the word "sex" with the word "gender" in the first paragraph.

2.14 Amend Subsection 404.1 by deleting the subsection in its entirety and by inserting in lieu thereof the following: "All regulations pertaining to handicapped facilities in the International Plumbing Code will be governed by the most recent edition of the "American National Standards Institute (ANSI) and the minimum requirements of the International Building Code. The ANSI plumbing requirements are included in Resource A in the IPC as part of this code."

2.15 Amend Subsection 405.3.1 by adding an exception to read as follows: "Exception: Lavatories in residential occupancies shall not be required to be 15 inches from the center of the lavatory to any side wall. This does not supersede accessibility requirements."

2.15.1 Amend Subsection 403.1.1 by deleting Exception #2 reference to multi-user facilities designed to serve all genders.

2.16 Amend Subsection 502.1 by adding thereto after the last sentence the following: "The first 12 inches of both hot and cold water lines from the water heater shall be metallic material or a material approved by the plumbing inspector."

2.17 Amend Subsection 504.6 by adding thereto a new numbered paragraph after numbered paragraph "13" to read as follows: "14. The relief valve shall be equipped with an approved heat transfer fitting and approved discharge piping or be metallic pipe."

2.17.1 Amend Subsection 504.6 By deleting # 14.

2.18 Amend Sections 602 and 610 to state "The Delaware Division of Public Health Plumbing Permit and Inspection Program does not test drinking water." at the end of each section.

2.19 Amend Table 605.3 by deleting in the parenthetical in the fifth row, first column after the words "Copper or copper-alloy tubing" the letters "M" and "WM".

2.20 Amend Table 605.4 by deleting in the parenthetical in the fourth row, first column after the words "Copper or copper-alloy tubing" the letters "M" and "WM".

2.20.1 Amend Subsection 605.15.2 by adding thereto after the words "above or below ground" the following sentence: "The use of all-purpose glue is prohibited unless it contains the specific ASTM certification for the utilized pipe and fittings."

2.21 Amend Subsection 607.3 by adding thereto the following after the last sentence: "All public water installations shall be required to have an expansion tank on storage water heaters installed between the water heater shut off valve and the water heater on the cold side."

2.22 Amend Subsection 608.3 by adding thereto a new subsection after subsection 608.3.1 to read: "608.3.2 Special equipment, water supply protection. There shall be sufficient space around special equipment for accessibility."

2.23 Amend Subsection 608.17.4 to add: "Fire sprinklers in 1 and 2 family dwelling units connected to the potable water system shall be regulated by The New Home Buyer's Fire Protection act, Title 6 Chapter 36 of Delaware code, requirements of local jurisdictions and requirements from the Delaware State Fire Marshal's office. Combined domestic and fire sprinkler systems in 1 and 2 family home systems shall utilize potable water piping and not require backflow protection to separate the fire sprinkler system from the potable water distribution system unless it is connected to a fire department connection or contains antifreeze in accordance with NFPA 13-D. The Division of Public Health does not approve the design of fire protection systems."

2.24 Amend Section 704 to add a new subsection 704.5 to read "Plumbing in structures with basements shall have a future vent that runs below the joist and is labeled future vent."

2.25 Amend Subsection 705.10.2 by deleting the exception.

2.26 Amend Subsection 712.3.5 by deleting the phrase "10 pipe diameters" in the last sentence and replacing it with the following phrase: "The waste line from sewage crock injector pump shall be the last connection leaving before the drain line goes through the foundation."

2.27 Amend Subsection 903.1 by adding: "12 inches above the roof."

2.28 Amend Subsection 903.2 by adding thereto after the first sentence the following sentence: "The stack shall be no less than 2 inches in diameter."

2.29 Amend Subsection 904.3 by deleting the words "or to a stack-type air admittance valve in accordance with Section 918.

2.30 Amend Subsection 918.1 by adding thereto after the last sentence the following: "The use of air admittance valves in lieu of standard vents shall be approved by the plumbing inspector prior to use or installation."

2.31 Amend Section 919 by deleting the section in its entirety.

2.32 Amend Section 920 by deleting the section in its entirety.

2.33 Amend Subsection 1101.1 by adding "The Delaware Division of Public Health Plumbing Program does not enforce the provisions of this chapter."

2.34 Amend Chapter 12 by adding "The Delaware Division of Public Health does not enforce the provisions of this chapter."

**History**
- *9 DE Reg. 786 (11/01/05)*
- *14 DE Reg. 813 (02/01/11)*
- *15 DE Reg. 1724 (06/01/12)*
- *19 DE Reg. 138 (08/01/15)*
- *23 DE Reg. 384 (11/01/19)*
- *26 DE Reg. 110 (08/01/22)*

##### **16 Del. Admin. Code § 4455-3.0** Miscellaneous Provisions for the DE Division of Public Health {#sec-4455-3.0 omnilex-key=us-de-regs-official--title-16--4455-3.0}

3.1 Procedures for License. Every person desiring to register as a master plumber engaged in the business of plumbing in the State of Delaware shall file an application with the Delaware Division of Professional Regulation.

3.2 Permission for a variance. Upon receipt of a written application for a variance, the Code Official may recommend granting written permission to vary from particular provisions set forth in these Regulations, when the extent of the variation is clearly specified and it is documented to the satisfaction of the Secretary of the Delaware Department of Health and Social Services or his/her appointed designee's that:

3.2.1 Such variation is necessary to obtain a beneficial use of an existing facility;

3.2.2 The variation is necessary to prevent a practical difficulty or unnecessary hardship; and

3.2.3 Appropriate alternative measures have been taken to protect the health and safety of the public and assure that the purpose of the provisions from which the variation is sought will be observed.

3.3 Time for recommendation. Within thirty (30) business days of the receipt of a written application for a variance, the Code Official shall recommend either: granting the variance, denying the variance or requesting further information from the applicant.

3.4 Appeal of denial. If the applicant has been denied a variance upon the recommendation of the Code Official, the applicant may appeal the decision by filing a written Notice of Appeal to the Secretary of the Delaware Department of Health and Social Services, or his/her designee.

3.5 Private Sewage Code. The private sewage code is regulated by the Delaware Department of Natural Resources and Environmental Control.

**History**
- *9 DE Reg. 786 (11/01/05)*
- *14 DE Reg. 813 (02/01/11)*
- *15 DE Reg. 1724 (06/01/12)*
- *19 DE Reg. 138 (08/01/15)*
- *23 DE Reg. 384 (11/01/19)*
- *26 DE Reg. 110 (08/01/22)*

##### **16 Del. Admin. Code § 4455-4.0** Information Regarding Plumbing For Food Establishments {#sec-4455-4.0 omnilex-key=us-de-regs-official--title-16--4455-4.0}

4.1 Scope. These Special Provisions shall be followed in addition to and shall not supersede the International Plumbing Code, the Delaware Food Code or these Regulations.

4.2 Use of Master Plumber. All plumbing shall be installed by a master plumber under a valid, current plumbing permit in accordance with these Regulations.

4.3 Backflow Prevention

4.3.1 Air gap, supply. An air gap between the water supply and the flood rim level of the plumbing fixture, equipment, or nonfood equipment shall be at least twice the diameter of the water supply inlet and may not be less than 25 mm (1 inch).

4.3.2 Air gap, drainage. A direct connection may not exist between the sewage system and a drain originating from equipment in which food, portable equipment, or utensils are placed. Equipment and fixtures utilized for the storage, preparation and handling of food shall discharge through an indirect waste pipe by means of an air gap.

4.3.3 Floor drains. Floor drains located within walk-in refrigerators or freezers in food establishments shall be indirectly connected to the sanitary drainage system by means of an air gap or air break as approved with a backwater valve.

4.3.4 Backflow prevention device. A backflow or back siphonage prevention device or assembly installed on a water supply system shall meet American Society of Sanitary Engineering (ASSE) standards for construction, installation, maintenance, inspection, and testing for that specific application and type of device.

4.3.5 Plumbing fixtures. The supply lines or fittings for every plumbing fixture shall be installed so as to prevent backflow. Plumbing fixtures shall provide backflow protection in accordance with ASSE A112.18.1.

4.3.6 Devices, appliances. All devices that connect to the water supply shall be provided with protection against backflow. This includes devices used for food preparation and processing, steamers, the storage of ice or food, ware washing machines, and other food service equipment.

4.3.7 Hose connections. Sillcocks, hose bibs, wall hydrants and other openings with a hose connection shall be protected by an atmospheric-type or pressure-type vacuum breaker or a permanently attached hose connection vacuum breaker. This subsection does not apply to water heater drain valve or clothes washing machines.

4.3.8 Beverage dispensers. The water supply connection to carbonated beverage dispensers shall be protected against backflow by a backflow preventer conforming to ASSE 1022 or by an air gap. The portion of the backflow preventer device downstream from the second check valve and the piping downstream there from shall not be affected by carbon dioxide gas.

4.4 Utility Service Installation

4.4.1 Front of wall lines. If lines are run in front of walls, lines shall be installed with stand-off brackets or other secure mounting method, such that a minimum clearance of one inch (1") exists between line and wall.

4.4.2 No floor installation. Exposed horizontal utility service, including water supply and drain lines, may not be installed on the floor.

4.5 Toilet Facilities

4.5.1 Toilet room. A toilet room shall be completely enclosed and provided with a tight-fitting and self-closing door that does not open into a food preparation area. This requirement does not apply where a toilet room is located outside a food establishment and does not open directly into the food establishment such as a toilet room that is provided by the management of a shopping mall.

4.5.2 Location. Toilet rooms shall be conveniently located and accessible to employees during all hours of operation.

4.5.3 Customer Facilities. Customer toilet facilities shall be required in all public establishments based on occupant load except they are not required in facilities intended for quick transactions, or takeout facilities with no customer dine in seating and having a customer access area less than or equal to 300 sq. ft.

4.6 Sinks

4.6.1 Water supply. All sinks shall be supplied with hot and cold running water under pressure.

4.6.2 Splashguard Dividers. Where less than 18 inches lateral separation exists between sinks and adjacent fixtures, food contact surfaces or open storage shelving, a splashguard divider constructed of a material which is durable, easily cleanable, non-toxic and impervious to moisture shall be installed; such divider may be wall-attached or fixture-attached and shall extend outward to the leading edge of the sink and extend vertically a minimum of 18 inches above the level plane of the sink bowl.

4.6.3 Hand washing sinks. These fixtures, when located in food preparation, food dispensing, beverage dispensing (including bar service area), food storage and ware washing areas, must be certified or classified under an approved industry standard for food equipment, such as NSF International, ETL Sanitation, UL for Sanitation, BISSC, or equivalent.

4.6.4 Separate sink required. A separate, single-compartment hand washing sink is required in food preparation, food dispensing, and ware washing areas; and in toilet rooms. Plan review is required by the Office of Food Protection on new Food Establishments to assess the quantity and placement of sinks unless otherwise waived by the code official.

4.6.5 Grease interceptor connection. Connection to a grease interceptor is not required for handwashing sinks.

4.7 Food Preparation Sinks

4.7.1 A food prep sink must be certified or classified under an approved industry standard for food equipment, such as NSF International, ETL Sanitation, UL for Sanitation, BISSC, or equivalent.

4.7.2 No disposal. A food preparation sink may not be used for disposal of mop water or liquid wastes.

4.7.3 Required indirect drain line. An indirect drain line connection through an air-gap is required.

4.7.4 Grease interceptor connection. Connection to a properly sized grease interceptor is required.

4.7.5 Multiple compartments. If a food preparation sink has two or more compartments, a separate waste line connection from each sink compartment through an air gap into a floor sink is required.

4.8 Ware washing Sinks

4.8.1 Industry standard. Ware washing sinks must be certified or classified under an approved industry standard for food equipment, such as NSF International, ETL Sanitation, and UL for Sanitation, BISSC, or equivalent.

4.8.2 No hand washing or disposal. A ware washing sink may not be used for hand washing or disposal of liquid wastes.

4.8.3 Required indirect drain line. An indirect drain line piped separately from each bowl through an air-gap is required.

4.8.4 Grease interceptor connection. Connection to a properly sized grease interceptor is required unless otherwise approved.

4.9 Service Sinks (for use as a janitorial sink, utility sink or mop sink)

4.9.1 Installation location. Wherever practical, a fixture service sink must be installed outside of the food preparation, food dispensing, food storage and ware wash areas.

4.9.2 Industry standard. Service sinks, when located in food preparation, food dispensing, food storage and ware washing areas, must be certified or classified under an approved industry standard for food equipment, such as NSF International, ETL Sanitation, UL for Sanitation, BISSC, or equivalent.

4.9.3 Minimum number required. A minimum of one service sink or receptor is required on each floor level of food operations. This fixture may be a sink or a curbed receptor.

4.9.4 Dual use. The dual use of a utility sink as a hand washing sink is not approved.

4.9.5 Grease interceptor connection. Connection to a grease interceptor is not required.

4.10 Pre-wash Sinks

4.10.1 Industry standard. Pre-wash sinks must be certified or classified under an approved industry standard for food equipment, such as NSF International, ETL Sanitation, and UL for Sanitation, BISSC, or equivalent.

4.10.2 Required indirect drain line. An indirect drain line connection through an air-gap is required.

4.10.3 Grease interceptor connection. Connection to a properly sized grease interceptor is required.

4.10.4 Food waste grinder. A food waste grinder may not be connected to a grease interceptor.

4.11 Mechanical Warewasher

4.11.1 Industry standard. Mechanical ware washers must be certified or classified under an approved industry standard for food equipment, such as NSF International, ETL Sanitation, UL for Sanitation, or equivalent.

4.11.2 Grease interceptor connections. The prewash sink for a dishwasher shall connect to a grease interceptor with a solids separator. Mechanical dishwashers without a prewash sink shall connect to the grease interceptor with a solids separator. Three-bowl sinks shall connect to a grease interceptor.

4.11.3 Indirect drain line connection. An indirect drain line connection through an air-gap is required.

4.12 Water Heater

4.12.1 Hot water supply. The water heater shall be sized to provide hot water as required to supply both the continuous requirements and the hourly peak demands of the facility. The continuous and hourly demands are based on the type of equipment and number of fixtures consuming hot water as required for food operations.

4.12.2 Total availability. The total hot water availability in gallons per hour (gph) from a water heater is the sum of the unit storage capacity plus the recovery rate at a 100×F rise.

4.12.3 Minimum storage capacity. A fuel-fired (gas or oil) water heater in a food establishment shall have a minimum storage capacity of thirty (30) gallons; an electric water heater shall have a minimum storage capacity of forty (40) gallons. Storage capacities larger than the minimum shall be required based on the type of equipment and number of fixtures consuming hot water.

4.12.4 Instant or tankless hot water heaters. Instant or tankless hot water heaters shall be sized to provide hot water as required to supply both the continuous requirements and the hourly peak demands of the facility. In some cases, more than 1 instant or tankless hot water heater may be required.

4.13 Grease Interceptor

4.13.1 Sizing. The grease interceptor must be sized in accordance with PDI standard G101.

4.13.2 Grease interceptor connection. Connection to a properly sized grease interceptor is required for all fixtures that discharge grease-laden waste, e.g., ware washing sinks, food prep sinks, pre-wash sinks for ware washers, woks, dishwashers without pre-wash sinks and other cooking equipment.

4.13.3 Sizing procedures. Follow these procedures for sizing a grease interceptor to a specific fixture:

4.13.3.1 Determine the liquid volume of the fixture in cubic inches (cu in) draining to the grease interceptor.

4.13.3.2 Determine the liquid capacity of the fixture in gallons by dividing the total cubic inches of the sink by 231 cubic inches per gallon.

4.13.3.3 Determine the actual drainage load (75% of fixture capacity).

4.13.3.4 Divide by 2 for the allowed 2 minute flow rate.

4.13.3.5 Select a unit corresponding to minimum unit flow rate.

4.13.3.6 Grease interceptors must have a flow control valve built in or installed in front of the inlet and a vent on the outflow side or otherwise be installed by manufacturer instructions.

Table 4.13.3a

EXAMPLE OF SIZING FOR GREASE INTERCEPTOR SELECTION

Select a grease interceptor for a three compartment warewashing sink with bowl

dimensions of 18" W x 24" L x 12" D

1. Volume = (18in x 24in x 12in) x 3 cmpts = (5,184 cu in) x 3 = 15,552 cubic

inches

2. Capacity = Volume (cu in) / 231 (cu in/gal) =15,552 / 231 = 67.3 gallons.

3. Drainage load = 67.3 gal x 0.75 = 50.4, or approximately 50 gallons per min.

grease interceptor is the minimum flow rate. Divide by 2 for the allowed 2 min flow rate

4. The rated capacity in pounds is twice the flow rate. A 50 gallon per minute

grease interceptor is equal to a 100 pound grease interceptor.

5. For multiple fixtures add together 100% of the largest flow rate, 50% of the 2nd

largest flow rate and 25% of all others.

**History**
- *9 DE Reg. 786 (11/01/05)*
- *14 DE Reg. 813 (02/01/11)*
- *15 DE Reg. 1724 (06/01/12)*
- *19 DE Reg. 138 (08/01/15)*
- *23 DE Reg. 384 (11/01/19)*
- *26 DE Reg. 110 (08/01/22)*

#### **4456** Hazardous Chemical Act

##### **16 Del. Admin. Code § 4456** Hazardous Chemical Act {#sec-4456 omnilex-key=us-de-regs-official--title-16--4456}

THIS REGULATION WAS REPEALED 8/1/2013, EFFECTIVE 8/11/2013.

**History**
- *17 DE Reg. 234 (08/01/13)*

##### **16 Del. Admin. Code § 4456-1.0** Preamble {#sec-4456-1.0 omnilex-key=us-de-regs-official--title-16--4456-1.0}

These Regulations Are Adopted By The State Board Of Health Pursuant To The Authority Invested In The Board By 16 Del.C. 122 (1), (3) (B) And (J), And 16 Del.C. 2412. The Purpose Of These Regulations Is To Ensure That Information Regarding Hazardous Chemicals Is Accessible To Employees Who May Be Exposed To Such Chemicals In The Workplace And To Emergency Service Organizations Whose Members May Be Exposed To Such Chemical Hazards During Emergency Situations. This Regulation Is Intended To Address Comprehensively The Issue Of Communicating Chemical Hazards To Employees In The Non-manufacturing Sector As Well As The Manufacturing Sector Until Such Time As The OSHA Hazard Communication Standard Takes Effect.

**History**
- *17 DE Reg. 234 (08/01/13)*

##### **16 Del. Admin. Code § 4456-2.0** Severability {#sec-4456-2.0 omnilex-key=us-de-regs-official--title-16--4456-2.0}

If Any Provision Or Application Of Any Provision Of These Regulations Is Held Invalid, That Invalidity Shall Not Affect Other Provisions Or Applications Of These Regulations.

**History**
- *17 DE Reg. 234 (08/01/13)*

##### **16 Del. Admin. Code § 4456-3.0** Definitions {#sec-4456-3.0 omnilex-key=us-de-regs-official--title-16--4456-3.0}

"Act" means the Hazardous Chemical Information Act as stated in 16 Del.C. Ch. 24.

“Agricultural Employer" means an employer with a workplace classified in Standard Industrial Classification (SIC) Codes 01 through 08.

"Article" means a manufactured item:

"Chemical Manufacturer" means an employer in Standard Industrial Classification (SIC) Codes 20 through 39 with a workplace where chemicals are produced for use or distribution.

"Chemical Name" means the scientific designation of a chemical in accordance with the nomenclature system developed by the International Union of Pure and Applied Chemistry or the Chemical Abstracts Service (CAS) rules of nomenclature or a name which will clearly identify the chemical for the purpose of conducting a hazard evaluation.

"Combustible Liquid" means any liquid having a flash point at or above 100° F (38.8 C), but below 200° F (93.3° C), except any mixture having components with flash points of 200° F (93.3° C), or higher, the total volume of which make up 99 percent or more of the total volume of the mixture.

"Common Name" means any designation or identification such as code name, code number, trade name, brand name or generic name used to identify a chemical other than by its chemical name.

"Compressed Gas" means:

"Container" means any bag, barrel, bottle, box, can, cylinder, drum, reaction vessel storage tank, or the like that contains a hazardous chemical. For purposes of this Act, pipes or piping systems are not considered to be containers.

"Corrosive" A chemical that causes visible destruction of, or irreversible alterations in, living tissue by chemical action at the site of contact. For example, a chemical is considered to be corrosive if, when tested on the intact skin of albino rabbits by the method described by the U.S. Department of Transportation in Appendix A to 49 CFR Part 173, it destroys or changes irreversibly the structure of the tissue at the site of contact following an exposure period of four hours.

"Designated Representative" means the individual or organization to whom an employee gives written authorization to exercise such employee's rights under this chapter. A recognized or certified collective bargaining agent shall be treated automatically as a designated representative without regard to written employee authorization.

"Distributor" means any business, other than a chemical manufacturer or importer, which supplies hazardous chemicals to other distributors or to purchasers.

"Employee" means any person who may be exposed to hazardous chemicals in his or her workplace under normal operating conditions or foreseeable emergencies. Office workers, ground maintenance, security personnel or nonresident management are not included unless their job performance routinely involves potential exposure to hazardous chemicals. For the purposes of this chapter, "employee" includes persons working for the State of Delaware and its political subdivisions, as well as members of volunteer emergency service organizations.

"Employer" means any individual, corporation, or association engaged in a business in Delaware that has employees, including the State and its political subdivisions. This term does not include persons who hire domestic workers or casual workers for their place of residence.

"Explosive" means a chemical that causes a sudden, almost instantaneous release of pressure, gas, and heat when subjected to sudden shock, pressure, or high temperature.

"Expose or Exposure" means that an employee is subjected to a hazardous chemical in the course of employment through any route of entry (inhalation, ingestion, skin contact or absorption, etc.) and includes potential (e.g., accidental or possible) exposure.

"Flammable" means a chemical that falls into one of the following categories:

"Aerosol Flammable" means an aerosol that, when tested by the method described in 16 CFR 1500.45, yields a flame projection exceeding 18 inches at full valve opening, or a flashback (a flame extending back to the valve) at any degree of valve opening;

"Gas, Flammable" means:

"Flash Point" means the minimum temperature at which a liquid gives off a vapor in sufficient concentration to ignite when tested as follows:

"Foreseeable Emergency" means any potential occurrence such as, but not limited to, equipment failure, rupture of containers, or failure of control equipment which could result in an uncontrolled release of a hazardous chemical into the workplace.

“Hazard Warning" means any words, pictures, symbols, or combination thereof appearing on a label or other appropriate form of warning which convey the hazards of the chemical (s) in the container (s).

"Hazardous Chemical" means any element, chemical compound or mixture of elements and/or compounds which is a physical hazard or health hazard.

"Health Hazard" means a chemical which is a carcinogen, toxic, highly toxic, an irritant, a corrosive, a sensitizer, a reproductive toxin (teratogen or mutagen), or affects a target organ such as the liver, kidney, eye, or skin, or an organ system such as the blood, or nervous system.

"Highly Toxic" A chemical falling within any of the following categories:

"Identity" means any chemical or common name which is indicated on the material safety data sheet (MSDS) for the chemical. The identity used shall permit cross-references to be made among the required Workplace Chemical List, the label and the MSDS.

"Importer" means the first business with employees within the Customs Territory of the United States which receives hazardous chemicals produced in other countries for the purpose of supplying them to distributors or manufacturing purchasers within the United States.

"Irritant" A chemical, which is not corrosive, but which causes a reversible inflammatory effect on living tissue by chemical action at the site of contact. A chemical is a skin irritant if, when tested on the intact skin of albino rabbits by the methods of 16 CFR 1500.41 for four hours exposure or by other appropriate techniques, it results in an empirical score of five or more. A chemical is an eye irritant if so determined under the procedure listed in 16 CFR 1500.42 or other appropriate techniques.

"Label" means any written, printed, or graphic material displayed on or affixed to containers of hazardous chemicals.

"Manufacturing Employer" means an employer with a workplace classified in SIC Codes 20 through 39 who manufacturers or uses a hazardous chemical.

"Material Safety Data Sheet (MSDS)" means a document containing chemical hazard and safe handling information, provided that, after November requirements of the OSHA Standard for such document contained in 29 CFR 1910.1200 (g).

"Mixture" means any combination of two or more chemicals if the combination is not, in whole or in part, the result of a chemical reaction.

"Non-manufacturing Employer" means an employer with a workplace in a SIC Code other than 20 through 39, the State of Delaware, its political subdivisions, and all volunteer emergency service organizations.

"OSHA Standard" means the Hazard Communication Standard issued by the Occupational Safety and Health Administration (OSHA) in Title 29 Code of Federal Regulations (CFR) Part 1910.1200 as published in the Federal Register Vol. 48, No. 228 dated November 25, 1983.

"Organic Peroxide" means an organic compound that contains the bivalent -0-0- structure and which may be considered to be a structural derivative of hydrogen peroxide where one or both of the hydrogen atoms has been replaced by an organic radical.

"Oxidizer" means a chemical other than a blasting agent or explosive as defined in 29 CFR 1910.109(a), that initiates or promotes combustion in other materials, thereby causing fire either of itself or through the release of oxygen or other gases.

"Physical Hazard" means a chemical for which there is scientifically valid evidence that it is a combustible liquid, a compressed gas, explosive, flammable, an organic peroxide, an oxidizer, pyrophoric, unstable (reactive) or water-reactive.

"Produce" means to manufacture, process, formulate, or repackage.

"Pyrophoric" means a chemical that will ignite spontaneously in air at a temperature of 130 F (54.4° C) or below.

"Responsible Party" means someone who can provide additional information on the hazardous chemical and appropriate emergency procedures, if necessary.

"Retail Food Sale Establishments" means a business classified in SIC Code 54 through 58.

"Retail Trade Establishments" means a business classified in SIC Code 52 through 59.

"Secretary" means the Secretary of the Department of Health and Social Services of the State of Delaware.

"Sensitizer" A chemical that causes a substantial proportion of exposed people or animals to develop an allergic reaction in normal tissue after repeated exposure to the chemical.

"Specific Chemical Identity" means the chemical name, Chemical Abstracts Service (CAS) Registry Number, or any other information that reveals the precise chemical designation of the substance.

"Technically Qualified Individual" means a person who, because of education, training, or experience, understands the health risks associated with hazardous chemicals, and is familiar with the protective procedures to be followed in the use and handling of such substances.

"Toxic" A chemical falling within any of the following categories:

"Trade Secret" means any confidential formula, pattern, process, device, information or compilation of information (including chemical name or other unique chemical identifier) that is used in an employer's business, and that gives the employer an opportunity to obtain an advantage over competitors who do not know or use it.

"Unstable (reactive)" means a chemical which in the pure state, or as produced or transported, will vigorously polymerize, decompose, condense, or will become self-reactive under conditions of shocks, pressure, or temperature.

"Use" means to package, handle, react, or transfer.

"Water-reactive" means a chemical that reacts with water to release a gas that is either flammable or presents a health hazard.

"Work Area" means a room or defined space in a workplace where hazardous chemicals are produced or used, and where employees are present.

"Workplace Chemical List" means the list of hazardous chemicals developed pursuant to Section 2.400 of these regulations.

"Workplace" means an establishment at one geographical location containing one or more work areas.

General Provisions

**History**
- *17 DE Reg. 234 (08/01/13)*

##### **16 Del. Admin. Code § 4456-4.0** Scope and Applications {#sec-4456-4.0 omnilex-key=us-de-regs-official--title-16--4456-4.0}

4.1 Scope

4.1.1 Chemical manufacturers or importers are required by the OSHA Hazard Communication Standard (29 CFR 1910.1200(d) to assess the hazards of chemicals which they produce or import by November 25, 1985. Distributors must transmit all information on hazardous chemicals received from manufacturers and available, but no later than November 25, 1985. All employers are required to provide information to their employees about the hazardous chemicals to which they are exposed by means of posters, labels and other forms of warning, material safety data sheets (MSDS) and training.

4.1.2 Employees who may be exposed to hazardous chemicals are guaranteed certain rights as specified in 16 Del.C. 2415 of the Delaware Code.

4.1.3 Compliance with the provisions of the Act shall not affect the liability of an employer with regard to the health and safety of employees or other persons exposed to hazardous chemicals, nor the employer's responsibility to take action to prevent occupational disease as may be required under any provision of law. Furthermore, providing information to an employee shall not affect the responsibility of a manufacturer, producer or formulator to warn the ultimate users of a hazardous chemical under any other provision of law.

4.2 Application

4.2.1 These regulations apply to any hazardous chemical which is known to be present in the workplace in such a way that employees may be exposed under normal conditions of use or in a foreseeable emergency or to which Emergency Service Organization personnel may be exposed in an emergency at the workplace.

4.2.2 These regulations apply to all non-manufacturing employers. Those non-manufacturing employers that adopt and comply with the OSHA Standard may be certified in compliance with these regulations except for Sections 5.3 and 5.4; 7.4, 7.7 and 7.8; and 8.2.4 and 8.2.5 by submitting a written request to the Bureau of Environmental Health.

4.2.3 These regulations apply to all manufacturing employers, importers and distributors until such time as the OSHA Standard goes into effect. Once in compliance with the OSHA Standard, manufacturers, importers and distributors regulated by OSHA will be exempt from these regulations except for Sections 5.3 and 5.4; 6.2.1, 8.1.3 and 8.1.4; and 8.2.4 and 8.2.5.

4.2.4 These regulations do not apply to the chemicals used in laboratories (research and development, commercial, and academic) provided that:

4.2.4.1 The laboratory is under the direct supervision or guidance of a technically qualified individual;

4.2.4.2 Labels on containers of incoming chemicals are not removed or defaced.

4.2.4.3 MSDS's received are maintained and kept readily accessible to employees and students;

4.2.4.5 Employees and students are informed of the hazards of the chemicals in the laboratory in accordance with Section 9.0.

4.2.4.4 A notice is posted informing employees and students of their rights under the act

4.2.4.6 The laboratory is not used primarily to produce hazardous chemicals in bulk for commercial purposes.

4.2.4.7 The laboratory provides the Emergency Information specified in 5.3 and 5.4.

4.2.5 These regulations do not apply to chemicals in the following:

4.2.5.1 Any manufactured article.

4.2.5.2 Food, drugs or cosmetics intended for personal consumption.

4.2.5.3 Retail food establishments.

4.2.5.4 Retail trade establishments except for repair and processing areas.

4.2.5.5 A workplace where hazardous chemicals are received in sealed packages and are kept less than five working days in the sealed package in which they are received provided that the following provisions are satisfied:

4.2.5.5.1 ) The Fire Chief with jurisdiction over the workplace and the Bureau of Environmental Health, Division of Public Health are provided in writing with the name(s) and telephone number(s) of a knowledgeable representative (s) of the company who can be contacted in an emergency; and,

4.2.5.5.2 An employee education program is established according to the requirements of Section 9.0 of these regulations.

4.2.5.6 Any food, food additive, color additive, drug or cosmetic as defined in the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301 et. seq.) and regulations issued under the Act.

4.2.5.7 Any distilled spirits (beverage alcohol's), wine or malt beverage intended for non-industrial use as defined in the Federal Alcohol Administration Act (27 U.S.C. et seq.) and regulations issued under the Act.

4.2.5.8 The workplace of an agricultural employer or employer group provided the Secretary of the Department of Agriculture certifies that the chemicals are covered by regulations adopted under the Federal Insecticide, Fungicide, and Rodenticide Act (40 CFR parts 162-180) or chemical not covered by the above laws or regulations are covered by these regulations.

4.2.5.9 Consumer products packaged for distribution to, and use by the general public. This includes any product purchased by an employer and used by an employee in the same physical form, concentration, and manner as used by consumers, and to which, in the employer's knowledge, when used according to the manufacturers instructions the employee exposure is not significantly greater than that of the consumer in the foreseeable consumer uses of the product.

**History**
- *17 DE Reg. 234 (08/01/13)*

##### **16 Del. Admin. Code § 4456-5.0** Hazard Communication {#sec-4456-5.0 omnilex-key=us-de-regs-official--title-16--4456-5.0}

5.1 All employers shall establish by January 1, 1986 a hazard communication program for their workplaces which shall include the following:

5.1.1 A poster informing employees of their rights under the Act (to be posted July 1, 1985);

5.1.2 The method the employer will use to ensure that all hazardous chemicals will be properly labeled

5.1.3 An employee education and training program (to be started on July 1, 1985);

5.1.4 The method an employer and a contractor will use to exchange information on any hazardous chemical their respective employees may be exposed to while performing their work and any suggestions for appropriate protective measures.

5.2 In addition to the above items, employers that use hazardous chemicals in quantities which exceed 55 gallons or 500 pounds (in aggregate quantity), employers shall also provide the following:

5.2.1 To employees:

5.2.1.1 A Workplace chemical List;

5.2.1.2 An MSDS file for each chemical listed on the Workplace Chemical List;

5.2.2 To the Fire Chief with jurisdiction over the workplace the following:

5.2.2.1 In writing, after January 1, 1985, the name(s) and telephone number(s) of responsible company representative(s) who can be contacted in the event of an emergency at the workplace, and shall update this information in writing at least annually;

5.2.2.2 A copy of the Workplace Place List if requested after January 1, 1986;

5.2.2.3 A copy of the MSDS for each chemical on the Workplace Chemical List if requested after January 1, 1986; and,

5.2.2.4 Permission for an on-site inspection of the work areas where the hazardous chemicals are used, produced, or stored after January 1, 1986.

5.3 By January 1, 1986, employers shall provide in writing to the Bureau of Environmental Health, Division of Public Health the name(s) who can be contacted in the event of an emergency at the workplace and shall update this information in writing at least annually.

5.4 Employers may rely on an existing hazard communication program designed to meet the OSHA Standard to comply with these regulations.

**History**
- *17 DE Reg. 234 (08/01/13)*

##### **16 Del. Admin. Code § 4456-6.0** Labels and Other Forms of Warning {#sec-4456-6.0 omnilex-key=us-de-regs-official--title-16--4456-6.0}

6.1 hemical Manufacturers, Importers and Distributors

6.1.1 Chemical manufacturers, importers or distributors shall ensure that each container of hazardous chemical sold for use in Delaware after November 25, 1985 is labeled, tagged or marked with at least the following information:

6.1.1.1 The identity of the hazardous chemical(s) which may be readily cross-referenced with the MSDS.

6.1.1.2 Appropriate hazard warnings.

6.1.1.3 The name and address of the chemical manufacturer, importer or other responsible party.

6.2 Employers

6.2.1 Employers who use or store hazardous chemicals shall ensure that after November 25, 1985 incoming containers of hazardous chemicals are labeled, tagged or marked with at least the following information:

6.2.1.1 The identity of the hazardous chemicals which may be readily cross-referenced with the Workplace Chemical List and MSDS;

6.2.1.2 Appropriate hazard warnings;

6.2.1.3 The name and address of the chemical manufacturer, importer or other responsible party.

6.2.2 Employers shall ensure that labels or other forms of warning provided on incoming containers are not removed or defaced.

6.2.3 Employers may substitute a labeling or marking system of their choice for a hazardous chemical container as long as it provides the information specified in 6.1.1 and is permanently displayed on the container.

6.2.4 Employers may use signs, placards, process sheets, batch tickets, operating procedures, or other such written materials instead of labels on stationary process containers. The alternative method must:

6.2.4.1 Identify the specific containers to which the warning is applicable.

6.2.4.2 Contain the information specified in 6.1.1.

6.2.4.3 Must be immediately available in the work area to employees during all work shifts.

6.2.5 Employers shall not require employees to work with hazardous chemicals from an unlabeled container, unless the container is a portable container which will be used during the work shift by the employee who actually performs the transfer of the hazardous chemical from a labeled container to the unlabeled portable container.

6.2.6 Labels or other forms of warning shall be legible and in English. Employers having employees who speak languages other than English may add the information required in Section 6.1.1 in their language.

**History**
- *17 DE Reg. 234 (08/01/13)*

##### **16 Del. Admin. Code § 4456-7.0** Workplace Chemical List {#sec-4456-7.0 omnilex-key=us-de-regs-official--title-16--4456-7.0}

7.1 Employers must review all chemicals used in the workplace for the existence of a hazard warning. If a warning of a health or physical hazard accompanies the chemical, it is considered hazardous for the purposes of this section.

7.2 Employers shall compile and maintain a Workplace Chemical List which shall contain the following information for each hazardous chemical used, handled or stored in the workplace in aggregate quantities which exceed 55 gallons or 500 pounds:

7.2.1 The chemical name, the common name, or the CAS Number used on the MSDS and container label.

7.2.2 The work area(s) in which the hazardous chemical is normally stored or used

7.3 The list may be prepared for individual work areas or the work place as a whole.

7.4 The employer must update the Workplace Chemical List at least annually and maintain the list for 30 years. In the event the business ceases to operate within the state, complete records shall be sent to the Bureau of Environmental Health, Division of Public Health.

7.5 The Workplace Chemical List must be readily accessible to employees and/or their representatives within the work area or in an area accessible to employees without the prior permission of the employer.

7.6 The employer shall make the Workplace Chemical List available to new or newly assigned employees prior to them working in any work area containing hazardous chemicals.

7.7 Employers shall provide a copy of the Workplace Chemical List to the Bureau of Environmental Health, Division of Public Health immediately upon request in an emergency or within five working days of a written request in a non-emergency situation.

7.8 The employer must provide a copy of the Workplace Chemical List to the Fire Chief with jurisdiction over the workplace immediately upon request in an emergency situation or within five working days of such a request in non-emergency situations.

**History**
- *17 DE Reg. 234 (08/01/13)*

##### **16 Del. Admin. Code § 4456-8.0** Material Safety Data Sheets {#sec-4456-8.0 omnilex-key=us-de-regs-official--title-16--4456-8.0}

8.1 Manufacturers, Distributors and Importers

8.1.1 manufacturers, distributors and imports shall provide Delaware manufacturing and non-manufacturing purchasers of hazardous chemicals the most current MSDS for each hazardous chemical purchased.

8.1.2 The most current MSDS shall be provided to each purchaser prior to or at the time of the initial shipment after January 1, 1985 and with the first shipment after an MSDS has been updated.

8.1.3 Each MSDS shall be in English and after November 25, 1985 contain at least the information required by the OSHA Standard in 29 CFR 1910.1200 (g) (2).

8.1.4 Employers shall provide to Bureau of Environmental Health, Division of Public Health with a copy of any MSDS immediately upon request in an emergency or within five days of a written request in a non-emergency situation.

8.2 Employers

8.2.1 Employers shall maintain a file of the most current MSDS's received from manufacturers, distributors, or importers for each chemical on the Workplace Chemical List.

8.2.2 Employers shall request in writing from the appropriate manufacturer, distributor, or importer any MSDS which they are required to maintain, but has not been provided to or at the time of shipment of the hazardous chemical.

8.2.3 MSDS's shall be readily accessible to employees or their designated representatives in the work area.

8.2.3.1 MSDS must be kept in the work area where practical.

8.2.3.2 Where it is not feasible to maintain an MSDS file in the work area, a copy of the MSDS requested by employees or their designated representatives shall be supplied within 2 working days of the request.

8.2.4 Employers shall provide to Bureau of Environmental Health, Division of Public Health a copy of an MSDS for each hazardous chemical listed on the Workplace Chemical List immediately upon request in an emergency or within five working days of a written request in a non-emergency situation.

8.2.5 Employers shall provide a copy of an MSDS for each hazardous chemical on the Workplace Chemical List to the local Fire Chief with jurisdiction over the workplace immediately upon request in an emergency or within five working days in a non-emergency situation.

**History**
- *17 DE Reg. 234 (08/01/13)*

##### **16 Del. Admin. Code § 4456-9.0** Employee Training {#sec-4456-9.0 omnilex-key=us-de-regs-official--title-16--4456-9.0}

9.1 Scope and Applicability

9.1.1 Employers must provide a training program on hazardous chemicals to all employees who use or handle hazardous chemicals or who may be exposed in a foreseeable emergency. The reportable limit of 55 gallons or 500 pounds does not apply to the training requirement; therefore, all hazardous chemicals in the employee's work area must be covered.

9.1.2 Employers shall develop their own program or if eligible utilize the program or materials made available by the Right-To-Know Information Office.

9.1.3 Employers shall provide this program to employees during working hours or after hours with compensation.

9.1.4 The program shall be provided upon hire for new employees, Yukon reassignment for newly assigned employees and a t least annually for all employees.

9.1.4.1 All employees shall be provided with the program before January 1, 1986.

9.1.4.2 Additional instruction shall be given whenever the potential for exposure is altered or new and significant information concerning the hazards of the chemical is received by the employer.

9.2 Content

9.2.1 Employee training shall include at least the following:

9.2.1.1 An explanation of then contents and requirements of the Act and these Regulations.

9.2.1.2 An explanation of the rights of an employee under the Act.

9.2.1.3 The location, availability and content of the workplace chemical list.

9.2.1.4 Inform employees of the location of hazardous chemical containers in the work area to which they are assigned. Employees assigned to more than one work area or plant-wide must be informed of each location of hazardous chemical containers.

9.2.1.5 An explanation of how to read labels on incoming containers, and the labeling system to be used by the employer in the work place if different from that used on incoming containers.

9.2.1.6 The location, availability and content of material safety data sheets and an explanation of how they are related to the workplace Chemical List and labels.

9.2.1.7 A general overview of occupational health principles covering such things as exposure, dose, risk, and safe exposure levels.

9.2.1.8 An explanation of the nature of health and physical hazards associated with the use of all hazardous chemicals (regardless of quantity) to which they may be exposed while in their work area to include:

9.2.1.8.1 Areas to be covered should include, physical hazard, routes of entry, acute and chronic affects of over exposure, symptoms of over exposure, safe levels of exposure as established by OSHA, NIOSH, ACGIH, or the employer; and,

9.2.1.8.2 Instruction may be given for each individual hazardous chemical or for groups of hazardous chemicals with similar health and safety risks or properties.

9.2.1.9 An explanation of the proper handling, storage and disposal methods for each of the hazardous chemicals present in the work area. Areas to be covered should include at least:

9.2.1.9.1 Measures taken by the employer to prevent or control exposure such as engineering controls, personal protective equipment, process changes, air monitoring, medical surveillance, emergency procedures for spills or leaks, how and where to dispose of wastes; and,

9.2.1.9.2 Measures an employee shall take to prevent or control exposure such as engineering controls, personal protective equipment supplied by the employer, personal hygiene practices, and observations that may be used to detect the presence or release of a hazardous chemical.

9.2.1.10 Literature or training materials provided by the manufacturer of the hazardous chemicals or the Right-To-Know Information Office may be provided to employees to satisfy the requirements of 9.2.1.7 and 9.2.1.8.

9.3 Records. Employers shall keep records of training sessions given to employees to include dates, names of employees present, signatures of employees, and content of training.

**History**
- *17 DE Reg. 234 (08/01/13)*

##### **16 Del. Admin. Code § 4456-10.0** Protection of Trade Secrets {#sec-4456-10.0 omnilex-key=us-de-regs-official--title-16--4456-10.0}

10.1 The specific chemical identity of a hazardous chemical may be withheld from disclosure under requirements of Section 2.200 (c) (2) and (3), 7.2 and 7.8, and 8.2.5 provided:

10.1.1 The claim that the information withheld is a trade secret can be supported;

10.1.2 MSDS'S are available to employees in the work area;

10.1.3 Information on properties and hazards is provided to the Fire Chief when requested.

10.1.4 Specific chemical identity and other relevant information is provided to health professionals diagnosing and treating an employee exposed to the chemical in accordance with the provisions listed in Section 10.2.

10.2 Where a treating health professional determines that a medical emergency exists and the specific chemical identity of a hazardous chemical identity of the trade secret chemical shall be immediately disclosed to the health professional. A written statement of need and a confidentiality agreement may be requested of the health professional as soon as circumstances permit.

10.3 In non-emergency situations, the specific chemical identity of a hazardous chemical shall be disclosed to a health professional providing medical or other occupational health professional as soon as circumstances permit.

10.3.1 The request is in writing;

10.3.2 The request describes in detail the occupational health needs for the information;

10.3.3 The request explains in detail why the disclosure of the specific chemical identity is essential and why information on control measures; monitoring and analysis methods; and diagnosis and treatment methods would not satisfy the occupational health needs described in 10.3.2 above;

10.3.4 The request includes a description of how the disclosed information will remain confidential; and

10.3.5 The health professional, and the employer or contractor of the health professional's services agree in a written confidentiality agreement that the trade secret information will not be used for any other purpose than those stated in the request. The information will not be released under any circumstance, other than to OSHA or Bureau of Environmental Health, Division of Public Health except as authorized by the terms of the agreement.

10.4 The confidentiality agreement authorized in 10.3.5 of this section:

10.4.1 May restrict the use of the information to the health purposes indicated in the written statement of need.

10.4.2 May provide for appropriate legal remedies in the event of a breach of the agreement, including stipulation of a reasonable pre-estimate of damages; and,

10.4.3 May not include requirements for the posting of a penalty bond.

10.5 If the health professional receiving the trade secret information decides that there is need to disclose it to OSHA or Bureau of Environmental Health, Division of Public Health, the provider of the information shall be informed by the health professional prior to, or at the same time of the disclosure to OSHA or Bureau of Environmental Health, Division of Public Health.

10.6 A denial of a request for trade secret information must be:

10.6.1 Delivered to the health professional within 30 days of the request;

10.6.2 In writing;

10.6.3 Supported by evidence as to the validity of the trade secret claim for the specific identity of the hazardous chemical;

10.6.4 Specific as to why the request is being denied; and,

10.6.5 Develop and maintain a training assistance program to aid employers who because of size or other practical reason cannot develop such a program themselves.

10.7 The health professional whose request for the information is denied may refer the request and written denial of the request to Bureau of Environmental Health, Division of Public Health for consideration.

Administrative And Enforcement Practices

**History**
- *17 DE Reg. 234 (08/01/13)*

##### **16 Del. Admin. Code § 4456-11.0** Administration {#sec-4456-11.0 omnilex-key=us-de-regs-official--title-16--4456-11.0}

11.1 Right-To-Know Information Office

11.1.1 The Right-To-Know Information Office within the Bureau of Environmental Health, Division of Public Health will administer the Outreach Program mandated by the Act.

11.1.2 The responsibilities of the office include, but are limited to the following:

11.1.2.1 Produce and distribute a suitable poster for informing employees of their rights under the Act;

11.1.2.2 Develop and distribute printed materials explaining the duties of employers, employees rights, and the effects of hazardous chemicals;

11.1.2.3 Publicize the existence of the Act and the services offered by the Right-To-Know Information Office;

11.1.2.4 Provide guidelines for employee training programs;

11.1.2.5 Develop and maintain a training assistance program to aid employers who because of size or other practical reason cannot develop such a program themselves.

11.1.2.5.1 This program shall consist at a minimum of literature or other training materials which can be distributed to employees by the employer.

11.1.2.5.2 The Right-To-Know Information Office will provide up to 25 copies of any titles of printed material to an employer free of charge. For requests in excess of 25 copies, the employer will be charged a fee equal to the cost of the material to the State plus the postage.

11.1.2.6 The Right-To-Know Information Office will place printed materials as well as audio-visual materials in at least one library in each county in the State for use by employers, employees, and citizens of Delaware.

11.1.3 The Right-To-Know Information Office is required by 16 Del.C. 2414(e) of the Act to respond to requests for information about hazardous chemicals from the citizens of Delaware.

11.1.3.1 A citizen of Delaware wishing general information on specific hazardous chemicals may contact the Right-To-Know Information Office by telephone or in writing to request the information.

11.1.3.2 A citizen of Delaware wanting specific information (such as a Workplace Chemical List or MSDS'S) on the hazardous chemicals used or stored by a specific employer must make the request in writing. These requests must include the following:

11.1.3.2.1 The name affiliation (if any), address and telephone number of the requester;

11.1.3.2.2 The specific information requested.

11.1.3.2.3 A description of the need for the information.

11.1.3.3 On receiving a written request for a Workplace Chemical List or MSDS for a specific manufacturer, importer, distributor or employer, Bureau of Environmental Health, Division of Public Health shall contact the company and obtain a copy of the information requested. The copy shall be sent within 5 working days of the request.

11.1.3.3.1 If trade secret information is included in the request, Bureau of Environmental Health, Division of Public Health may decide to request the manufacturer, importer or employer at that time to substantiate the trade secret claim in accordance with section 11.2.

11.1.3.3.2 If no trade secret information is included in the request, Bureau of Environmental Health, Division of Public Health, at its discretion, shall provide a copy of the material, or access to facilities to copy the information. For documents in excess of 20 pages, Bureau of Environmental Health, division of Public Health will charge the requester a fee equal to its non-labor cost to copy the material.

11.1.3.4 Bureau of Environmental Health, Division of Public Health reserves the right to refuse requests which are felt to be unreasonable because of the quantity or scope of the material requested.

11.2 Trade Secret Claims

11.2.1 Bureau of Environmental Health, Division of Public Health will evaluate the validity of a trade secret claim when a request is made by an employee, employee representative, Fire Chief or when Bureau of Environmental Health, Division of Public Health determines it is appropriate.

11.2.2 When a request is made by Bureau of Environmental Health, Division of Public Health, the response shall be made in writing and shall contain at least the following:

11.2.2.1 Product name;

11.2.2.2 Uses;

11.2.2.3 Name, address and telephone number of the organization requesting trade secret protection;

11.2.2.4 Name and title of an individual who may be contacted about the claim;

11.2.2.5 Identification of items to be protected by the claim and the reasons for protecting them; and,

11.2.2.6 A signed statement that the information to be protected by the request is already registered as a trade secret under a specific provision of federal law, or if not already registered, the information is related to a proprietary process which if disclosed would compromise the competitive position of the manufacturer, importer, or employer.

11.2.3 The manufacturer, importer, or employer will be given 30 days to respond to the request.

11.2.4 The manufacturer, importer, or employer shall have 30 days after notification in writing by Bureau of Environmental Health, Division of Public Health that a trade secret claim is not valid to request an administrative hearing on the determination. Such hearings shall be held in a manner similar to that provided in 29 Del.C. 101.

11.2.5 Bureau of Environmental Health, Division of Public Health may revoke an approved trade secrets claim if new information on the validity of the claim is received and accepted. In the event of a revocation, Section 11.4 shall apply as if the claim were rejected.

11.2.6 Any failure of a manufacturer, importer, or employer to provide the information requested by Bureau of Environmental Health, Division of Public Health shall be considered grounds for denial of the trade secret claim.

11.2.7 All documents submitted to Bureau of Environmental Health, Division of Public Health as part of the trade secret claim verification procedure shall be considered confidential and will be protected from disclosure provided all information to be protected is marked by the word "CONFIDENTIAL" in bold type or stamp.

11.2.8 All documents submitted to Bureau of Environmental Health, Division of Public Health as part of the trade secret claim verification procedure which have been marked by the word "CONFIDENTIAL" in bold type or stamp will be returned at the conclusion of the verification process.

**History**
- *17 DE Reg. 234 (08/01/13)*

##### **16 Del. Admin. Code § 4456-12.0** Enforcement {#sec-4456-12.0 omnilex-key=us-de-regs-official--title-16--4456-12.0}

12.1 Inspections and Surveys

12.1.1 After January 1, 1986, the Bureau of Environmental Health, Division of Public Health shall regularly visit the workplaces of employers to assess compliance with the Act.

12.1.2 Employers shall permit during normal operating hours representatives of Bureau of Environmental Health, Division of Public Health to enter any workplace to inspect individual work areas and any records related to compliance with the Act. Items to be inspected shall include at a minimum the following:

12.1.2.1 Location of Posters;

12.1.2.2 Workplace Chemical List;

12.1.2.3 Container Labeling;

12.1.2.4 MSDS file;

12.1.2.5 Training program content and records;

12.1.2.6 Documentation that emergency contact information has been sent to local Fire chief;

12.1.2.7 Any other documentation deemed necessary to determine compliance with the Act.

12.1.3 A compliance survey questionnaire will be distributed at least annually after January 1, 1986 by Bureau of Environmental Health, Division of Public Health to a sample of employers covered by Delaware's unemployment insurance law. This survey will be used to estimate overall level of compliance with the Act.

12.1.3.1 The questionnaire shall be completed by the employer, signed by a responsible company official certifying the truthfulness of the information provided, and returned to Bureau of Environmental Health, Division of Public Health within 30 days of receipt.

12.1.3.2 Failure to return the completed survey form to Bureau of Environmental Health, Division of Public Health within the time specified in 12.1.3.1 above shall result in an inspection of the workplace and compliance records.

12.1.3.3 Bureau of Environmental Health, Division of Public Health will publish the results of the compliance survey annually no late than 90 days after the date the survey forms are due to be returned.

12.2 Complaints, Investigations, Hearings, and Penalties

12.2.1 Written complaints from employees or their designated representatives relating to alleged violations of the Act by employers shall be investigated by Bureau of Environmental Health, Division of Public Health within 10 working days of the receipt of the written complaint.

12.2.1.1 Complaints from employees of manufacturing employers will be handled by Bureau of Environmental Health, Division of Public Health, until the OSHA Standard becomes fully effective on May 25, 1986. After this time, these complaints will be referred to OSHA for investigation.

12.2.1.2 All complaints from employees of non-manufacturing employers shall be handled by Bureau of Environmental health, Division of Public Health.

12.2.2 Employers shall permit during normal operating hours representatives of Bureau of Environmental Health, Division of Public Health, representative must present prior credentials and written notice to the employer at the time of the inspection or investigation.

12.2.3 Employers found to be in violation of the Act after an investigation by Bureau of Environmental Health, Division of Public Health shall be notified by certified mail, return receipt requested, and will have 14 days from the date of receipt of the notice of violation to comply, present a reasonable schedule for compliance, or request an administrative hearing.

12.2.3.1 A citable violation of the Act is defined as each incidence of non-compliance found during an inspection or investigation, or the failure by an employer to submit requested information to Bureau of Environmental Health, Division of Public Health or the local fire chief within the times specified in Sections 7.7 and 7.8, and 8.2.4 and 8.2.5.

12.2.3.2 An employer may request an administrative hearing of the violation determination, if such request is made in writing within 10 days of receipt of the notice of violation. The hearing will be conducted in accordance with agency procedures.

12.2.3.3 Each case decision shall be incorporated in a final order which shall include where appropriate:

12.2.3.3.1 A brief summary of the evidence;

12.2.3.3.2 The findings of fact based upon the evidence;

12.2.3.3.3 The conclusions of law;

12.2.3.3.4 A concise statement of the agencies determination or action in the case.

12.2.4 Employers who do not comply or present a reasonable schedule to Bureau of Environmental Health, Division of Public Health, for compliance shall be subject to a fine of not more than $500 per violation.

**History**
- *17 DE Reg. 234 (08/01/13)*

#### **4459** Lead-Based Paint Hazards

##### **16 Del. Admin. Code § 4459-1.0** General Provisions {#sec-4459-1.0 omnilex-key=us-de-regs-official--title-16--4459-1.0}

1.1 Preamble. These regulations are adopted by the Secretary of Delaware Health and Social Services pursuant to the Authority invested in the Secretary by 16 Del.C. §122(3)(t). These regulations, which exclude homeowners working on their own residence under proper State of Delaware, county, and local requirements and whose residence is not occupied by a person or persons other than the owner and the owner’s immediate family and no child residing in the residence has been identified as having an elevated blood lead level.

1.2 Purpose. These regulations shall be construed and applied to promote their underlying purpose of protecting the public health. They establish standards by which certified public or private organizations, firms, companies, and individuals engaged in lead-based paint activities in target housing and child-occupied facilities shall adhere. These regulations establish standards for lead-based paint activities, including the training and certification of companies and workers engaged in lead-based paint activities, the establishment of work standards for lead-based paint activities, the accreditation of lead-based paint activities training programs, and the establishment of procedures for enforcement. Individuals and firms are encouraged to choose to require more stringent requirements.

1.3 Severability. If any provision or application of any provision of these regulations is held invalid, that invalidity shall not affect other provisions or applications of these regulations.

**History**
- *16 DE Reg. 537 (11/01/12)*
- *26 DE Reg. 697 (02/01/23)*
- *16 DE Reg. 537 (11/01/12)*
- *26 DE Reg. 697 (02/01/23)*
- *27 DE Reg. 766 (04/01/24)*
- *16 DE Reg. 537 (11/01/12)*
- *26 DE Reg. 697 (02/01/23)*
- *27 DE Reg. 766 (04/01/24)*
- *16 DE Reg. 537 (11/01/12)*
- *26 DE Reg. 697 (02/01/23)*
- *27 DE Reg. 766 (04/01/24)*
- *16 DE Reg. 537 (11/01/12)*
- *26 DE Reg. 697 (02/01/23)*
- *27 DE Reg. 766 (04/01/24)*
- *11 DE Reg. 759 (12/01/07)*
- *16 DE Reg. 537 (11/01/12)*
- *26 DE Reg. 697 (02/01/23)*
- *27 DE Reg. 766 (04/01/24)*

##### **16 Del. Admin. Code § 4459-2.0** Definitions {#sec-4459-2.0 omnilex-key=us-de-regs-official--title-16--4459-2.0}

"Abatement" means any measure or set of measures designed to permanently eliminate lead-based paint hazards. Abatement includes, but is not limited to:

"Accessible surface" means any interior or exterior surface, such as an interior windowsill, that a young child can mouth or chew.

"Accredited training program" means a training program that has been accredited by the Secretary, EPA, or a State or Tribal Program authorized by EPA to provide lead-based paint activities training.

“Accredited course” means a lead-based paint activities training course that has been accredited by the Secretary, EPA, or a State or Tribal Program authorized by EPA.

"Adequate quality control" means a plan or design which ensures the authenticity, integrity, and accuracy of samples, including dust, soil, and paint chip or paint film samples. Adequate quality control also includes provisions for representative sampling.

“Arithmetic mean” means the algebraic sum of data values divided by the number of data values (e.g., the sum of the concentration of lead in several soil samples divided by the number of samples).

“Business day” means Monday through Friday with the exception of State of Delaware and Federal holidays.

“Certification examination” means a test administered by the Secretary that measures an individual’s knowledge of lead-based paint activities in a specific category or discipline.

"Certified Abatement Worker" means an individual who has been certified by the Secretary to perform abatements pursuant to Section 4.0.

"Certified firm" means a company, partnership, corporation, sole proprietorship, association, or other business entity that performs lead-based paint activities to which the Secretary has issued a certificate of approval pursuant to Section 4.0.

"Certified Inspector" means an individual who has been certified by the Secretary to conduct inspections pursuant to Section 4.0. A certified inspector also samples for the presence of lead in dust and soil for the purpose of abatement clearance testing.

"Certified Project Designer" means an individual who has been certified by the Secretary, to prepare abatement project designs, occupant protection plans, and abatement reports pursuant to Section 4.0.

"Certified Risk Assessor" means an individual who has been certified by the Secretary to conduct risk assessments pursuant to Section 4.0.

"Certified Supervisor" means an individual who has been certified by the Secretary, to supervise and conduct abatements, and to prepare occupant protection plans and abatement reports pursuant to Section 4.0.

"Child-occupied facility" means a building, or portion of a building, constructed prior to 1978, visited regularly by the same child, 6 years of age or under on at least 2 different days within any week (Sunday through Saturday period), provided that each day's visit lasts at least 3 hours, and the combined weekly visits last at least 6 hours and the combined annual visits last at least 60 hours. Child-occupied facilities may include, but are not limited to, day-cares, preschools, and kindergarten classrooms.

"Clearance levels" are values that indicate the maximum amount of lead permitted in dust on a surface following completion of an abatement activity.

"Common area" means a portion of a building that is generally accessible to all occupants. Such an area may include, but is not limited to, hallways, stairways, laundry and recreational rooms, playgrounds, community centers, garages, and boundary fences.

“Common Area Group” means a group of common areas that are similar in design, construction, and function.

"Component" or “Building Component” means specific design or structural elements or fixtures of a building, residential dwelling, or child-occupied facility that are distinguished from each other by form, function, and location. These include, but are not limited to, interior components such as: ceilings, crown moldings, walls, chair rails, doors, door trim, floors, fireplaces, radiators, and other heating units, shelves, shelf supports, stair treads, stair risers, stair stringers, newel posts, railing caps, balustrades, windows and trim (including sashes, windows heads, jambs, sills or stools and troughs), built in cabinets, columns, beams, bathroom vanities, counter tops and air conditioners; and exterior components such as: painted roofing, chimneys, flashing, gutters and down spouts, ceilings, soffits, fascias, rake boards, corner boards, bulkheads, doors and door trim, fences, floors, joists, lattice work, railings and railing caps, siding handrails, stair risers and treads, stair stringers, columns, balustrades, windowsills or stools and troughs, casings, sashes, and wells and air conditioners.

“Concentration” means the relative content of a specific substance contained within a larger mass, such as the amount of lead (in micrograms per grams or parts per million by weight) in a sample of dust or soil.

"Containment" means a process to protect workers, building occupants and the environment by controlling exposure to the lead-contaminated dust and debris created during an abatement.

"Course agenda" means an outline of the key topics to be covered during a training course, including the time allotted to teach each topic.

"Course test" means an evaluation that measures the overall effectiveness of the training which shall test the trainees' knowledge and retention of the topics covered during the course.

“Course test blueprint” means written documentation identifying the proportion of course test questions devoted to each major topic in the course curriculum.

"Department" means the Department of Health & Social Services as defined in 29 Del.C. §7904(a).

"Deteriorated paint" means any interior or exterior paint or other coating that is cracking, flaking, chipping, chalking, or peeling, or any paint or coating located on an interior or exterior surface or fixture that is otherwise damaged or separating from the substrate of a building component.

"Discipline" means 1 of the specific types or categories of lead-based paint activities identified in these regulations for which individuals may receive training from accredited programs and become certified by the Secretary. For example, "abatement worker" is a discipline.

"Distinct painting history" means the application history, as indicated by its visual appearance or a record of application, over time, of paint or other surface coatings, to a component or room.

"Documented methodologies" are methods or protocols used to sample for the presence of lead in paint, dust, and soil.

“Dripline” means the area within 3 feet surrounding the perimeter of a building.

“Dust wipe sample” means a sample collected by wiping a representative surface of known area, as determined by ASTM E1728, “Standard Practice for Field Collection of Settled Dust Samples Using Wipe Sampling Methods for Lead Determination by Atomic Spectrometry Techniques, or equivalent method, with an acceptable wipe material as defined in ASTM E 1792, “Standard Specification for Wipe Sampling Materials for Lead in Surface Dust.”

"Elevated blood lead level” or "(EBLL)" means an excessive absorption of lead that is a concentration of lead in whole blood of 3.5 µg/dL (micrograms of lead per deciliter of whole blood) or higher for a single venous test.

"Encapsulant" means a substance that forms a barrier between lead-based paint and the environment using a liquid-applied coating (with or without reinforcement materials) or an adhesively bonded covering material.

"Encapsulation" means the application of an encapsulant.

"Enclosure" means the use of rigid, durable construction materials that are mechanically fastened to the substrate in order to act as a barrier between lead-based paint and the environment.

"EPA" means U.S. Environmental Protection Agency.

"Firm" means any business company or partnership, sole proprietorship or individual doing business, association, non-profit organization, or other business entity, whether or not incorporated.

"Friction surface" means any interior or exterior surface that is subject to abrasion or friction, including, but not limited to window, floor, and stair tread surfaces.

“Guest instructor" means an individual, who meets or exceeds the requirements in subsection 3.3.2, has submitted documentation of these qualifications as provided in subsections 3.3.4.1 through 3.3.4.3 to the training provider, and is designated by the training manager or principal instructor to provide instruction specific to the lecture, hands-on activities, or work practice components of a course.

"Hands-on skills assessment" means an evaluation which tests the trainees' ability to satisfactorily perform the work practices and procedures identified in these regulations, as well as any other skill taught in a training course.

"Hazardous waste" means any waste subject to Delaware Department of Natural Resources and Environmental Control regulation as required in 7 Del.C. Ch. 63.

"HUD" means U.S. Department of Housing and Urban Development.

"Impact surface" means any interior or exterior surface such as surfaces on doors that is subject to damage by repeated impact or contact.

"Inspection" means a surface-by-surface investigation to determine the presence of lead-based paint and the provision of a written report, or electronic equivalent, explaining the results of the investigation.

"Interim controls" means a set of measures designed to temporarily reduce human exposure or likely exposure to lead-based paint hazards, including specialized cleaning, repairs, maintenance, painting, temporary containment, ongoing monitoring of lead-based paint hazards or potential hazards, and the establishment and operation of management and resident education programs.

“Interior windowsill” means the portion of the horizontal window ledge that protrudes into the interior of the room.

"Lead-based paint" means paint or other surface coatings that contain lead equal to or in excess of 1.0 milligrams per square centimeter or more than 0.5% by weight.

"Lead-based paint activities" means, in the case of target housing and child-occupied facilities, inspection, risk assessment and abatement, as defined in these regulations.

“Lead-based paint activities courses” means initial and refresher training courses (worker, supervisor, inspector, risk assessor, project designer) provided by accredited training programs.

"Lead-based paint hazard" means lead-contaminated dust, lead-contaminated soil, or lead-based paint that is deteriorated or present in accessible surfaces, friction surfaces, or impact surfaces that could result in adverse human health effects.

"Lead-contaminated dust" means surface dust in residential dwellings or child-occupied facilities that contains an area or mass concentration of lead at or in excess of levels identified by both the State of Delaware and the EPA.

"Lead-contaminated soil" means bare soil on residential real property or on the property of a child-occupied facility that contains lead at or in excess of levels identified both by the State of Delaware and the EPA.

"Lead hazard screen" means a limited risk assessment activity that involves limited paint and dust sampling as described in subsection 5.3.

"Living area" means any area of residential dwelling used by 1 or more children aged 6 and under, including, but not limited to, living rooms, kitchen areas, dens, playrooms, and children's bedrooms.

“Loading” means the quantity of a specific substance present per unit of surface area, such as the amount of lead in micrograms contained in the dust collected from a certain surface area divided by the surface area in square feet or square meters.

“Local government” means a county, city, town, district, association, or other public body (including an agency comprised of 2 or more of the foregoing entities) created under State law.

"Multi-family dwelling" means a structure that contains more than 1 separate residential dwelling unit, which is used or occupied, or intended to be used or occupied, in whole or in part, as the home or residence of 1 or more persons.

“Non-profit” means any entity that has demonstrated to any branch of the Federal Government or to a State, municipal, tribal, or territorial government, that no part of its net earnings inures to the benefit of any private shareholder or individual.

"Paint in poor condition" means 10 square feet or more of deteriorated paint on exterior components with large surface areas; or more than 2 square feet of deteriorated paint on interior components with large surface areas (e.g., walls, ceilings, floors, doors); or more than 10% of the total surface areas of the component is deteriorated on interior or exterior components with small surface areas (windowsills, baseboards, soffits, trim).

"Permanently covered soil" means soil that has been separated from human contact by the placement of a barrier consisting of solid, relatively impermeable materials, such as pavement or concrete. Grass, mulch, and other landscaping materials are not considered permanent covering.

"Person" means any natural or judicial person including any individual, corporation, partnership, or association; any Indian Tribe, State, or political subdivision thereof; any interstate body; and any department, agency, or instrumentality of the Federal, State, or local government.

“Play area” means an area of frequent soil contact by children aged 6 and under as indicated by, but not limited to, such factors including the following: the presence of play equipment (e.g., sandboxes, swing sets, and sliding boards), toys, or other children's possessions, observations of play patterns, or information provided by parents, residents, care givers, or property owners.

"Principal instructor" means the individual who has the primary responsibility for organizing and teaching a particular course.

"Proficiency test" means an extensive written examination designed to validate a person’s level of competence regarding lead abatement techniques and safety, to include: knowledge of health hazards related to human exposure to lead dust and lead painted surfaces; construction safety; application of lead safe work practices; and containments designed to reduce or minimize worker and building occupant exposure to lead hazards, specialized equipment designed to reduce lead exposures or hazards for workers and residence occupants, specialized lead-based paint removal using chemicals, hazardous waste management, and specialized work practices.

"Recognized laboratory" means an environmental laboratory recognized by the EPA as being capable of performing an analysis for lead compounds in paint, soil, and dust.

"Reduction" means measures designed to reduce or eliminate human exposure to lead-based paint hazards through methods including interim controls and abatement.

“Renovation” means the modification of any existing structure, or portion thereof, that results in the disturbance of painted surfaces, unless that activity is performed as part of an abatement as defined by this part. The term renovation includes (but is not limited to): the removal, modification, or repair of painted surfaces or painted components (e.g., modification of painted doors, surface restoration, window repair, surface preparation activity (e.g., sanding, scraping, or other such activities that may generate paint dust); the removal of building components (e.g., walls, ceilings, plumbing, windows); weatherization projects (e.g., cutting holes in painted surfaces to install blown-in insulation or to gain access to attics, planing thresholds to install weather stripping) and interim controls that disturb painted surfaces. A renovation performed for the purpose of converting a building, or part of a building, into target housing or a child-occupied facility is a renovation. The term renovation does not include minor repair and maintenance activities, as defined by EPA regulations at 745.83.

“Residential building” means a building containing 1 or more residential dwellings.

"Residential dwelling" means a detached single-family dwelling unit, including attached structures such as porches and stoops; or a single-family dwelling unit in a structure that contains more than 1 separate residential dwelling unit, which is used or occupied, or intended to be used or occupied, in whole or in part, as the home or residence of 1 or more persons.

"Risk assessment" means an on-site investigation to determine the existence, nature, severity, and location of lead-based paint hazards, and the provision of a written report, or electronic equivalent, by the individual or the firm conducting the risk assessment, explaining the results of the investigation and options for reducing lead-based paint hazards.

“Room” means a separate part of the inside of a building, such as a bedroom, living room, dining room, kitchen, bathroom, laundry room, or utility room. To be considered a separate room, the room must be separated from adjoining rooms by built-in walls or archways that extend at least 6 inches from an intersecting wall. Half-walls or bookcases count as room separators if built in. Movable or collapsible partitions or partitions consisting solely of shelves or cabinets are not considered built-in walls. A screened-in porch that is used as a living area is a room.

"Secretary" means the Administrator of the Department of Health and Social Services (DHSS) of the State of Delaware or the Secretary’s designee, who shall hereafter in this document be referred to as: Secretary; the Secretary; or, Secretary, DHSS.

“Soil sample” means a sample collected in a representative location using ASTM E1727, Standard Practice for Field Collection of Soil Samples for Lead Determination by Atomic Spectrometry Techniques, or equivalent method.

“Start date” means the first day of any lead-based paint activities training course or lead-based paint abatement activity.

“Start date provided to the Secretary” means the start date included in the original notification or the most recent start date provided to the Secretary in an updated notification.

“State” means any State of the United States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, the Northern Mariana Islands, or any other territory or possession of the United States.

"Target housing" means any housing constructed prior to 1978 or constructed during or after 1978 and contains components with lead-based paint.

"Training curriculum" means an established set of course topics for instruction in an accredited training program for a particular discipline designed to provide specialized knowledge and skills.

"Training hour" means at least 50 minutes of actual learning, including, but not limited to, time devoted to lecture, learning activities, small group activities, demonstrations, evaluations, and, if applicable, hands-on experience.

"Training manager" means the individual responsible for administering a training program and monitoring the performance of principal instructors and guest instructors.

"Training program" means lead training curriculum accredited by the Secretary and offered to the public by a training provider.

"Training provider" means a firm that has been approved by the Delaware Department of Health and Social Services to provide training in Delaware and accredited by the Secretary to conduct accredited lead-based paint activities training programs to individuals engaged in lead-based paint activities.

"Visual inspection for clearance testing" means the visual examination of a residential dwelling or a child-occupied facility following an abatement to determine whether or not the abatement has been successfully completed.

"Visual inspection for risk assessment" means the visual examination of a residential dwelling or a child-occupied facility to determine the existence of deteriorated lead-based paint or other potential sources of lead-based paint hazards.

“Weighted arithmetic mean” means the arithmetic mean of sample results weighted by the number of subsamples in each sample. Its purpose is to give influence to a sample of relative to the surface area it represents. A single surface sample is comprised of a single subsample. A composite sample may contain from 2 to 4 subsamples of the same area as each other and of each single surface sample in the composite. The weighted arithmetic mean is obtained by summing, for all samples, the product of the sample’s result multiplied by the number of subsamples in the sample and dividing the sum by the total number of subsamples contained in all samples. For example, the weighted arithmetic mean of a single surface sample containing 60 µg/ft², a composite sample (3 subsamples) containing 100 µg/ft², and a composite sample (4 subsamples) containing 110 µg/ft² is 100 µg/ft². This result is based on the equation [60+(3*100)+(4*110)]/(1+3+4).

“Window trough” means, for a typical double-hung window, the portion of the exterior windowsill between the interior windowsill (or stool) and the frame of the storm window. If there is no storm window, the window trough is the area that receives both the upper and lower window sashes when they are both lowered. The window trough is sometimes referred as the window “well.”

**History**
- *16 DE Reg. 537 (11/01/12)*
- *26 DE Reg. 697 (02/01/23)*
- *16 DE Reg. 537 (11/01/12)*
- *26 DE Reg. 697 (02/01/23)*
- *27 DE Reg. 766 (04/01/24)*
- *16 DE Reg. 537 (11/01/12)*
- *26 DE Reg. 697 (02/01/23)*
- *27 DE Reg. 766 (04/01/24)*
- *16 DE Reg. 537 (11/01/12)*
- *26 DE Reg. 697 (02/01/23)*
- *27 DE Reg. 766 (04/01/24)*
- *16 DE Reg. 537 (11/01/12)*
- *26 DE Reg. 697 (02/01/23)*
- *27 DE Reg. 766 (04/01/24)*
- *11 DE Reg. 759 (12/01/07)*
- *16 DE Reg. 537 (11/01/12)*
- *26 DE Reg. 697 (02/01/23)*
- *27 DE Reg. 766 (04/01/24)*

##### **16 Del. Admin. Code § 4459-3.0** Accreditation of Training Programs and Application and Renewal Requirements {#sec-4459-3.0 omnilex-key=us-de-regs-official--title-16--4459-3.0}

3.1 Accreditation of training programs. It is unlawful for any person or firm to provide training or offer to provide training for any discipline of lead-based paint activity without first possessing an approval from the Secretary as an accredited training program.

3.1.1 Accredited training programs shall offer and provide only training for the disciplines for which they are approved.

3.1.2 The Secretary approves an accredited training program for any firm or business that applies and meets the qualifications specified in these regulations.

3.1.3 A training provider may seek accreditation to offer lead-based paint activities courses in any of the following disciplines: Inspector, Risk Assessor, Supervisor, Project Designer, and Abatement Worker. A training provider may also seek accreditation to offer refresher courses for each of the above listed disciplines.

3.2 Application process. The following are procedures a training provider shall follow to receive accreditation to offer lead-based paint activities courses:

3.2.1 A training provider seeking accreditation shall submit a written application to the Secretary containing the following information:

3.2.1.1 The training provider’s business name, address, and telephone number.

3.2.1.2 Written evidence that the applicant's instructor has been approved by the Delaware Department of Education as a training provider if the training is part of any public education curriculum.

3.2.1.3 A list of courses for which it is applying for accreditation.

3.2.1.4 A statement signed by the training program manager certifying that the training program meets the requirements established in these regulations. If a training program uses EPA-recommended model training materials, or training materials approved by the Secretary, the training program manager shall include a statement certifying that, as well.

3.2.1.5 The name and documentation of the qualifications of the training program manager.

3.2.1.6 The names and documentation of qualifications of any principal instructors.

3.2.1.7 If a training provider does not use EPA-recommended model training materials or training materials approved by the Secretary, its application for accreditation shall also include:

3.2.1.7.1 A copy of the student and instructor manuals, or other materials to be used for each course.

3.2.1.7.2 A copy of the course agenda for each course.

3.2.1.8 All training providers shall include in their application for accreditation the following:

3.2.1.8.1 A description of the facilities and equipment to be used for lecture and hands-on training.

3.2.1.8.2 The name, address, and location of the training facility.

3.2.1.8.3 A description of the activities and procedures that will be used for conducting the assessment of hands-on skills for each course.

3.2.1.8.4 A copy of the quality control plan as described in subsection 3.3.9.

3.2.1.8.5 An electronic payment, a certified check, or a check written on a business account in the appropriate amount made payable to the Division of Public Health.

3.2.1.8.6 A copy of the course test blueprint for each course.

3.2.2 If a training program meets the requirements in subsection 3.3, then the Secretary shall approve the application for accreditation no more than 90 days after receiving a complete application from the training provider. In the case of approval, a certificate of accreditation shall be sent to the applicant. In the case of disapproval, a letter describing the reasons for disapproval shall be sent to the applicant. Prior to disapproval, the Secretary may, at the Secretary’s discretion, work with the applicant to address inadequacies in the application for accreditation. The Secretary, within the 90-day period, may also request additional materials retained by the training provider under subsection 3.9. If the Secretary requests additional materials, the time period for approval may extend beyond 90 days. If a training provider's application is disapproved, the provider may reapply for accreditation at any time. Application fees for disapproved training programs will not be refunded.

3.2.3 A training provider may apply for accreditation to offer courses or refresher courses in as many disciplines as it chooses. A training provider may seek accreditation for additional courses at any time as long as the provider can demonstrate that it meets the requirements of this section.

3.3 Requirements for the accreditation of training programs. For a training provider to obtain accreditation from the Secretary to offer lead-based paint activities courses, the program shall meet the following requirements:

3.3.1 The training program shall employ a training manager who has demonstrated experience, education, or training in the construction industry in the areas of lead abatement, painting, carpentry, renovation, remodeling, occupational safety and health or industrial hygiene, and meets 1 of the following requirements:

3.3.1.1 At least 2 years of experience, education, or training in teaching workers or adults, that is satisfactory to the Secretary; or

3.3.1.2 A bachelor's or graduate degree in building construction technology, engineering, industrial hygiene, safety, public health, education, business administration or program management or a related field; or

3.3.1.3 Two years of experience in managing a training program specializing in environmental hazards.

3.3.2 The training manager shall designate a qualified principal instructor for each course who has:

3.3.2.1 Demonstrated experience, education, or training in teaching workers or adults; and

3.3.2.2 Successfully completed at least 16 hours of any EPA-accredited or EPA-authorized State or Tribal-accredited lead-specified training; and

3.3.2.3 Demonstrated experience, education, or training in lead abatement, painting, carpentry, renovation, remodeling, occupational safety and health, or industrial hygiene.

3.3.3 The principal instructor shall be responsible for the organization of the course, course delivery, and oversight of the teaching of all course material. The training manager may designate guest instructors as needed to for a portion of the course to provide instruction specific to the lecture, hands-on activities, or work practice portions of a course. However, the principal instructor is primarily responsible for teaching the course materials and must be present to provide instruction (or oversight of portions of the course taught by guest instructors) for the course for which he has been designated as the principal instructor.

3.3.4 The following documents shall be accepted as evidence that training managers and principal instructors have the education, work experience, training requirements, or demonstrated experience, specifically listed in subsections 3.3.1 and 3.3.2. This documentation must be submitted with the accreditation application. Those documents include the following:

3.3.4.1 Official academic transcripts or diploma as evidence of meeting the education requirements.

3.3.4.2 Resumes, letters of reference, or documentation of work experience, as evidence of meeting the work experience requirements.

3.3.4.3 Certificates from train-the-trainer courses and lead-specific training courses, as evidence of meeting the training requirements.

3.3.5 The training program shall ensure the availability of, and provide adequate facilities for, the delivery of the lecture, course test, hands-on training, and assessment activities. This includes providing training equipment that reflects current work practices and maintaining or updating the equipment and facilities as needed.

3.3.6 To become accredited in the following disciplines, the training program shall provide training courses that meet the following training requirements.

3.3.6.1 Inspector course - a minimum of 24 training hours, with a minimum of 8 hours devoted to hands-on training activities. The minimum curriculum requirements for the Inspector course are contained in subsection 3.4.1.

3.3.6.2 Risk Assessor course - a minimum of 16 training hours, with a minimum of 4 hours devoted to hands-on training activities. The minimum curriculum requirements for the Risk Assessor course are contained in subsection 3.4.2.

3.3.6.3 Supervisor course - a minimum of 32 training hours, with a minimum of 8 hours devoted to hands-on activities. The minimum curriculum requirements for the Supervisor course are contained in subsection 3.4.3.

3.3.6.4 Project Designer course - a minimum of 8 training hours. The minimum curriculum requirements for the Project Designer course are contained in subsection 3.4.4.

3.3.6.5 Abatement Worker course - a minimum of 16 training hours, with a minimum of 8 hours devoted to hands-on training activities. The minimum curriculum requirements for the Abatement Worker course are contained in subsection 3.4.5.

3.3.7 For each course offered, the training program shall conduct either a course test at the completion of the course, and if applicable, a hands-on skills assessment, or in the alternative, a proficiency test for that discipline. Each student must successfully complete the hands-on skills assessment and receive a passing score on the course test to pass any course, or successfully complete a proficiency test.

3.3.7.1 The training manager is responsible for maintaining the validity and integrity of the hands-on skills assessment or proficiency test to ensure that it accurately evaluates the trainees' performance of the work practices and procedures associated with the course topics. For quality assurance, there will be periodic revision of the course assessment or proficiency test.

3.3.7.2 The training manager is responsible for maintaining the validity and integrity of the course test to ensure that it accurately evaluates the trainees' knowledge and retention of the course topics. For quality assurance, there shall be periodic revision of the course assessment or proficiency test. The course test blueprint shall be submitted to the Secretary.

3.3.7.3 The course test shall be developed in accordance with the test blueprint submitted with the training accreditation application.

3.3.8 The training program shall issue unique course completion certificates to each individual who passes the training course. The course completion certificate shall include:

3.3.8.1 The name, unique identification number, and address of the individual.

3.3.8.2 The business name, address and phone number of the accredited training program provider and the name of the training manager.

3.3.8.3 The name of the particular course that the individual completed.

3.3.8.4 Dates of course completion/test passage.

3.3.9 The training manager shall develop and implement a quality control plan. The plan shall be used to maintain and improve the quality of the training program over time. This plan shall contain at least the following elements:

3.3.9.1 Procedures for periodic revision of training materials and the course test to reflect innovations in the field.

3.3.9.2 Procedures for the training manager's annual review of principal instructor competency.

3.3.10 The training program shall offer courses that teach the applicable work practice standards for conducting lead-based paint activities contained in Section 5.0. These standards must be taught in the appropriate courses and training environments to provide trainees with the knowledge needed to perform the lead-based paint activities they are responsible for conducting.

3.3.11 The training manager shall be responsible for ensuring that the training program complies at all times with all of the requirements in this section.

3.3.12 The training provider and training manager must allow the Secretary to conduct, at the Secretary’s discretion, either announced or unannounced audits of the training programs to verify the contents of the application for accreditation as described in subsection 3.2 and to confirm compliance with all program accreditation requirements.

3.3.13 The training manager must provide notification of lead-based paint activities courses offered.

3.3.13.1 The training manager must provide the Secretary with notification of all lead-based paint activities courses offered. The Secretary must receive the original notification at least 7 business days prior to the start date of any lead-based paint activities course.

3.3.13.2 The training manager must provide the Secretary updated notification when lead-based paint activities courses will begin on a date other than the start date specified in the original notification, as follows:

3.3.13.2.1 For lead-based paint activities courses beginning prior to the start date provided to the Secretary, an updated notification must be received by the Secretary at least 7 business days before the new start date.

3.3.13.2.2 For lead-based paint activities courses beginning after the start date provided to the Secretary, an updated notification must be received by the Secretary at least 2 business days before the start date provided to the Secretary.

3.3.13.2.3 The training manager must update the Secretary of any change in location of lead-based paint activities courses at least 7 business days prior to the start date provided to the Secretary.

3.3.13.2.4 The training manager must update the Secretary regarding any course cancellations, or any other change to the original notification. Updated notifications must be received by the Secretary at least 2 business days prior to the start date provided to the Secretary.

3.3.13.2.5 Each notification, including updates, must include the following:

3.3.13.2.5.1 Notification type (original, update, cancellation).

3.3.13.2.5.2 Training program name, the Delaware accreditation number, address, and telephone number.

3.3.13.2.5.3 Course discipline and type (initial/refresher).

3.3.13.2.5.4 Dates and times of training.

3.3.13.2.5.5 Training locations, telephone number, and address.

3.3.13.2.5.6 Principal instructor's name.

3.3.13.2.5.7 Training manager's name and signature.

3.3.13.2.6 Notification must be accomplished using any of the following methods: Written or electronic notification to the Secretary. Written and electronic notifications of lead-based paint activities course schedules can be accomplished by using the guidance and sample form provided online at http://dhss.delaware.gov/dhss/dph/hsp/leadregcomm.html. All written notifications must be delivered by U.S. Postal Service, fax. All written notifications must be delivered by U.S. Postal Service, fax, commercial delivery service, or hand delivery (persons submitting notification by U.S. Postal Service are reminded that they should allow 3 additional business days for delivery in order to ensure that the Secretary receives the notification by the required date).

3.3.13.2.7 Lead-based paint activities courses must not begin on a date, or at a location other than that specified in the original notification unless an updated notification identifying a new start date or location is submitted, in which case the course must begin on the new start date or location specified in the updated notification.

3.3.13.2.8 No training program shall provide lead-based paint activities courses without first notifying the Secretary of such activities in accordance with the requirements of subsection 3.3.13.

3.3.14 The training manager must provide notification following completion of lead-based paint activities courses.

3.3.14.1 The training manager must provide the Secretary notification after the completion of any lead-based paint activities course. This notice must be received by the Secretary no later than 10 business days following course completion.

3.3.14.2 The notification must include the following:

3.3.14.2.1 Training program name, the Delaware accreditation number, address, and telephone number.

3.3.14.2.2 Course discipline and type (initial/refresher).

3.3.14.2.3 Dates of training.

3.3.14.2.4 The following information for each student who took the course:

3.3.14.2.4.1 Name.

3.3.14.2.4.2 Address.

3.3.14.2.4.3 Date of birth.

3.3.14.2.4.4 Course completion certificate number.

3.3.14.2.4.5 Course test score.

3.3.14.2.4.6 A digital photograph of the student.

3.3.14.2.5 Training manager's name and signature.

3.3.14.3 Notification must be accomplished using any of the following methods: Written or electronic notification to the Secretary. Written and electronic notifications following lead-based paint activities training courses can be accomplished by using the guidance and sample form provided online at http://dhss.delaware.gov/dhss/dph/hsp/leadregcomm.html. All written notifications must be delivered by U.S. Postal Service, fax, commercial delivery service, or hand delivery (persons submitting notification by U.S. Postal Service are reminded that they should allow 3 additional business days for delivery in order to ensure that the Secretary receives the notification by the required date).

3.4 Minimum training curriculum requirements. To become accredited to offer lead-based paint courses in the specific disciplines listed in this Section, training programs must ensure that their courses of study include, at a minimum, the following course topics. Requirements ending in an asterisk (*) indicate areas that require hands-on activities as integral portions of the course.

3.4.1 Inspector.

3.4.1.1 Role and responsibilities of an Inspector.

3.4.1.2 Background information on lead and its adverse health effects.

3.4.1.3 Background information on Federal, State of Delaware, and local regulations and guidance that pertains to lead-based paint and lead-based paint activities.

3.4.1.4 Liability and insurance issues relating to lead-based paint abatement.

3.4.1.5 Lead-based paint inspection methods, including selection of rooms, and components for sampling or testing.*

3.4.1.6 Paint, dust, and soil sampling methodologies.*

3.4.1.7 Clearance standards and testing, including random sampling.*

3.4.1.8 Preparation of the final written, or electronic equivalent, inspection report.*

3.4.1.9 Record keeping.

3.4.2 Risk Assessor.

3.4.2.1 Role and responsibilities of a Risk Assessor.

3.4.2.2 Collection of background information to perform a risk assessment.

3.4.2.3 Sources of environmental lead contamination such as paint, surface dust and soil, water, air, packaging, and food.

3.4.2.4 Liability and insurance issues relating to lead-based paint abatement.

3.4.2.5 Visual inspection for the purposes of identifying potential sources of lead-based paint hazards.*

3.4.2.6 Lead hazard screen protocol.

3.4.2.7 Sampling for the other sources of lead exposure.*

3.4.2.8 Interpretations of lead-based paint and other lead sampling results, including all applicable State of Delaware or Federal guidance or regulations pertaining to lead-based paint hazards.*

3.4.2.9 Development of hazard control options, the role of interim controls and operations and maintenance activities to reduce lead-based paint hazards.

3.4.2.10 Preparation of a final written, or electronic equivalent, risk assessment report.

3.4.3 Supervisor.

3.4.3.1 Role and responsibilities of a Supervisor.

3.4.3.2 Background information on lead and its adverse health effects.

3.4.3.3 Background information on Federal, State of Delaware, and local regulations and guidance that pertain to lead-based paint abatement.

3.4.3.4 Liability and insurance issues relating to lead-based paint abatement.

3.4.3.5 Risk assessment and inspection report interpretation.*

3.4.3.6 Development and implementation of an occupant protection plan and abatement report.

3.4.3.7 Lead-based paint hazard recognition and control.*

3.4.3.8 Lead-based paint abatement and lead-based paint hazard reduction methods, including restricted practices.*

3.4.3.9 Interior dust abatement/cleanup or lead-based paint hazard control and reduction methods.*

3.4.3.10 Soil and exterior dust abatement or lead-based paint hazard control and reduction methods.*

3.4.3.11 Clearance standards and testing.*

3.4.3.12 Cleanup and waste disposal.

3.4.3.13 Record keeping.

3.4.4 Project Designer.

3.4.4.1 Role and responsibilities of a Project Designer.

3.4.4.2 Liability and insurance issues relating to lead-based paint abatement.

3.4.4.3 Development and implementation of an occupant protection plan for large scale abatement projects.

3.4.4.4 Lead-based paint abatement and lead-based paint hazard reduction methods, including restricted practices for large scale abatement projects.

3.4.4.5 Interior dust abatement/cleanup or lead hazard control and reduction methods for large scale abatement projects.

3.4.4.6 Clearance standards and testing for large scale abatement projects.

3.4.4.7 Integration of lead-based paint abatement methods with modernization and rehabilitation projects for large scale abatement projects.

3.4.5 Abatement Worker.

3.4.5.1 Role and responsibilities of an Abatement Worker.

3.4.5.2 Background information on lead and its adverse health effects.

3.4.5.3 Background information on Federal, State of Delaware, and local regulations and guidance that pertain to lead-based paint abatement.

3.4.5.4 Lead-based paint hazard recognition and control.*

3.4.5.5 Lead-based paint abatement and lead-based paint hazard reduction methods, including restricted practices.*

3.4.5.6 Interior dust abatement methods/cleanup or lead-based paint hazard reduction.*

3.4.5.7 Soil and exterior dust abatement methods or lead-based paint hazard reduction.*

3.5 Requirements for the accreditation of refresher training programs. A training provider may seek accreditation to offer refresher training courses in any of the following disciplines: Inspector, Risk Assessor, Supervisor, Project Designer, and Abatement Worker. To obtain accreditation to offer refresher training, a training provider must meet the following minimum requirements.

3.5.1 Refresher courses shall review the curriculum topics of the full-length course listed under subsection 3.4, as appropriate. In addition, to become accredited to offer refresher training courses, training providers shall ensure their courses of study include, at a minimum, the following:

3.5.1.1 An overview of current safety practices relating to lead-based paint activities in general, as well as specific information pertaining to the appropriate discipline.

3.5.1.2 Current laws and regulations relating to lead-based paint in general, as well as specific information pertaining to the appropriate discipline.

3.5.1.3 Current technologies relating to lead-based paint activities in general, as well as specific information pertaining to the appropriate discipline.

3.5.2 Each refresher course, except for the project designer course, shall last a minimum of 8 training hours. The Project Designer refresher course shall last a minimum of 4 training hours. Refresher courses for all disciplines, except Project Designer, must include a hands-on portion.

3.5.3 For each refresher course offered (except Project Designer), the training provider shall conduct both a hands-on assessment, and at the completion of the course, a course test.

3.5.4 A training provider may apply for accreditation of a refresher course concurrently with its application for accreditation of the corresponding training course as described in subsection 3.2. If so, the Secretary shall use the approval process described in subsection 3.2. In addition, the minimum requirements contained in subsection 3.3, except for requirements in subsection 3.3.6 and subsections 3.5.1, 3.5.2, and 3.5.3 shall also apply to the refresher course.

3.5.5 A training provider seeking accreditation to offer refresher training courses only shall submit to the Secretary a written application containing the following information:

3.5.5.1 The refresher course training provider's name, address, and telephone number.

3.5.5.2 A list of courses for which it is applying for accreditation.

3.5.5.3 The name and documentation of the qualifications of the training program manager.

3.5.5.4 The names and documentation of the qualifications of the principal instructor.

3.5.5.5 A statement signed by the training program manager certifying that the refresher training program meets the requirements established in subsection 3.3, except for the requirements in subsection 3.3.6. If a training program uses EPA-recommended model training materials, or training materials approved by the Secretary, the training program manager shall include a statement certifying that, as well.

3.5.5.6 If the refresher training course materials are not based on EPA-developed training materials or training materials approved by the Secretary, the training provider's application for accreditation shall include:

3.5.5.6.1 A copy of the student and instructor manuals to be used for each course.

3.5.5.6.2 A copy of the course agenda for each course.

3.5.5.7 All refresher training providers shall include in their application for accreditation the following:

3.5.5.7.1 A description of the facilities and equipment to be used for lecture and hands-on training.

3.5.5.7.2 The name, address, and location of the training facility.

3.5.5.7.3 A description of the activities and procedures that will be used for conducting the assessment of hands-on skills for each course, if applicable.

3.5.5.7.4 A copy of the quality control plan as described in subsection 3.3.9.

3.5.5.7.5 A certified check or a check written on a business account in the appropriate amount made payable to the Division of Public Health.

3.5.5.7.6 A copy of the course test blueprint for each course.

3.5.5.8 The requirements in subsections 3.3.1 through 3.3.5 and subsections 3.3.7 through 3.3.14 apply to refresher training providers.

3.5.5.9 If a refresher training program meets these requirements, the Secretary shall approve the application for accreditation no more than 90 days after receiving a complete application from the refresher training provider. In the case of approval, a certificate of accreditation shall be sent to the applicant. In the case of disapproval, a letter describing the reasons for disapproval shall be sent to the applicant. Prior to disapproval, the Secretary may, at the Secretary’s discretion, work with the applicant to address inadequacies in the application for accreditation. The Secretary, within the 90-day period, may also request additional materials. If the Secretary requests additional materials, the time period for approval may extend beyond 90 days. If a refresher training provider's application is disapproved, the program provider may reapply for accreditation at any time. Application fees for disapproved refresher training programs will not be refunded.

3.6 Re-accreditation of training programs.

3.6.1 Unless re-accredited, a training program’s accreditation (including refresher training accreditation) shall expire 2 years after the date of issuance. If a training program meets the requirements of this section, the training program shall be re-accredited.

3.6.2 A training provider seeking program re-accreditation shall submit an application no later than 180 days before its accreditation expires.

3.6.3 The training provider’s application for program re-accreditation shall contain:

3.6.3.1 The training provider's name, address, and telephone number.

3.6.3.2 A list of courses for which it is applying for re-accreditation.

3.6.3.3 The name and qualifications of the training program manager.

3.6.3.4 The names and qualifications of the principal instructors.

3.6.3.5 A description of any material changes to the training facility, equipment or course materials since its last application was approved.

3.6.3.6 A statement signed by the program manager stating:

3.6.3.6.1 That the training program complies at all times with all requirements in subsections 3.3 and 3.5, as applicable; and

3.6.3.6.2 The record keeping and reporting requirements in subsection 3.9 shall be followed.

3.6.3.7 A certified check or a check written on a business account in the appropriate amount made payable to the Division of Public Health.

3.6.4 The Secretary has the authority to audit the training program to verify the contents of the application for re-accreditation as described in subsection 3.6.3. The training provider shall allow the Secretary to audit the training program.

3.7 Suspension, revocation, and modification of accredited training programs.

3.7.1 The Secretary may, after notice, and an opportunity for hearing, suspend, revoke, or modify training provider or program accreditation, including refresher training accreditation, if a training provider, training manager, or other person with supervisory authority over the training program has:

3.7.1.1 Misrepresented the contents of a training course.

3.7.1.2 Failed to submit required information or notifications in a timely manner.

3.7.1.3 Failed to maintain required records.

3.7.1.4 Falsified accreditation records, instructor qualifications, or other accreditation-related information or documentation.

3.7.1.5 Failed to comply with the training standards and requirements in this section.

3.7.1.6 Failed to comply with Federal, State of Delaware, or local lead-based paint statutes or regulations.

3.7.1.7 Made false or misleading statements in its application for accreditation or re-accreditation.

3.7.1.8 Denied the Secretary access to enter premises or facilities where training providers and training programs conduct business to execute reasonable inspection to ensure compliance with regulations.

3.7.2 In addition to an administrative or judicial finding of violation in any jurisdiction, execution of a consent agreement in settlement of an enforcement action constitutes, for purposes of this section, evidence of a failure to comply with relevant statutes or regulations.

3.8 Procedures for suspension, revocation, or modification of training program accreditation.

3.8.1 Prior to taking action to suspend, revoke, or modify the accreditation of a training provider or program, the Secretary shall notify the affected entity in writing of the following:

3.8.1.1 The legal and factual basis for the suspension, revocation, or modification.

3.8.1.2 The anticipated commencement date and duration of suspension, revocation, or modification.

3.8.1.3 Actions, if any, which the affected entity may take to avoid suspension, revocation, or modification, or to receive accreditation in the future.

3.8.1.4 The opportunity and method for requesting a hearing prior to final action to suspend, revoke, or modify accreditation.

3.8.1.5 Any additional information which the Secretary may provide.

3.8.2 If a hearing is requested by the accredited training provider, the Secretary shall:

3.8.2.1 Provide the affected entity an opportunity to offer written statements in response to the Secretary's assertions of the legal and factual basis for its proposed action, and any other explanations, comments, and arguments it deems relevant to the proposed action.

3.8.2.2 Provide the affected entity such other procedural opportunities as the Secretary may deem appropriate to ensure a fair and impartial hearing.

3.8.2.3 Appoint an official Hearing Officer. No person shall serve as Hearing Officer if the person has had any prior involvement with the specific matter.

3.8.3 The Hearing Officer appointed pursuant to subsection 3.8.2 shall:

3.8.3.1 Conduct a fair, orderly, and impartial hearing within 90 days of the request for a hearing.

3.8.3.2 Consider all relevant evidence, explanation, comment, and argument submitted.

3.8.3.3 Notify the Secretary in writing within 45 days of completion of the hearing of the Hearing Officer's decision. The Secretary shall either accept or reject the decision. If accepted, the Secretary issues a final order within 45 of receiving the Hearing Officer’s decision. Such an order is a final agency action, which may be subject to judicial review.

3.8.4 If the Secretary determines that the public health, interest, or welfare warrants immediate action to suspend the accreditation of any training provider or program prior to the opportunity for a hearing, or if the training provider or program denies the Secretary access for purposes of inspection, the Secretary shall:

3.8.4.1 Notify the affected entity of its intent to immediately suspend training program accreditation for the reasons listed in subsection 3.7.1. If a suspension, revocation, or modification notice has not previously been issued pursuant to subsection 3.7.1, it shall be issued at the same time the emergency suspension notice is issued.

3.8.4.2 Notify the affected entity in writing of the grounds for the immediate suspension and why it is necessary to suspend the entity's accreditation before an opportunity for a suspension, revocation, or modification hearing.

3.8.4.3 Notify the affected entity of the anticipated commencement date and duration of the immediate suspension.

3.8.4.4 Notify the affected entity of its right to request a hearing on the immediate suspension within 15 days of the suspension taking place and the procedures for the conduct of such a hearing.

3.8.5 Any notice, decision, or order issued by the Secretary under this section, any transcripts or other verbatim record of oral testimony, and any documents filed by an accredited training provider in a hearing under this section shall be available to the public. Any such hearing at which oral testimony is presented shall be open to the public, except that the Hearing Officer may exclude the public to the extent necessary to allow presentation of information which may be entitled to confidential treatment.

3.8.6 The public shall be notified of the suspension, revocation, modification, or reinstatement of a training program's accreditation through appropriate mechanisms.

3.9 Training program record keeping requirements.

3.9.1 Accredited training providers shall maintain, and make available to the Secretary, upon request, the following records:

3.9.1.1 All documents specified in subsection 3.3.4 that demonstrate the qualifications of the training manager and principal instructors listed in subsections 3.3.1 and 3.3.2.

3.9.1.2 Current curriculum/course materials and documents reflecting any changes made to these materials.

3.9.1.3 Information regarding how the hands-on assessment is conducted, including, but not limited to:

3.9.1.3.1 Who conducts the assessment.

3.9.1.3.2 How the skills are graded.

3.9.1.3.3 What facilities are used.

3.9.1.3.4 The pass/fail rate.

3.9.1.4 The quality control plan as described in subsection 3.3.9.

3.9.1.5 Results of the students' hands-on skills assessments and course tests, and a record of each student's course completion certificate.

3.9.1.6 The course test blueprint.

3.9.1.7 Any other material not listed above in subsections 3.9.1.1 through 3.9.1.6 that was submitted to the Secretary as part of the program's application for accreditation.

3.9.2 The training provider shall retain these records at the address specified on the training provider accreditation application or as modified in accordance with subsection 3.9.3 for a minimum of 3 years and 6 months.

3.9.3 The training provider shall notify the Secretary in writing within 30 days of changing the address specified on its training program accreditation application or transferring the records from that address.

3.10 Amendment of accreditation.

3.10.1 A training provider must amend its program accreditation within 90 days of the date a change occurs to information included in the program’s most recent application. If the training provider fails to amend its program accreditation within 90 days of the date the change occurs, the program may not provide training until its accreditation is amended.

3.10.2 To amend an accreditation, a training provider must submit a completed ‘‘Accreditation Application for Training Providers,’’ signed by an authorized agent of the training provider, noting on the form that it is submitted as an amendment and indicating the information that has changed.

3.10.3 If the amendment includes a new training program manager, any new or additional principal instructors, or any new permanent training locations, the training provider is not permitted to provide training under the new training manager or offer courses taught by any new principal instructors or at the new training locations until the Secretary approves the amendment or 30 days have elapsed, whichever occurs earlier. Except:

3.10.3.1 If the amendment includes a new training program manager or new or additional principal instructor that was identified in a training provider accreditation application that EPA has already approved under this section, the training provider may begin to provide training under the new training manager or offer courses taught by the new principal instructor on an interim basis as soon as the provider submits the amendment to the Secretary. The training provider may continue to provide training under the new training manager or offer courses taught by the new principal instructor if the Secretary approves the amendment or does not disapprove the amendment within 30 days.

3.10.3.2 If the amendment includes a new permanent training location, the training provider may begin to provide training at the new permanent training location on an interim basis as soon as the provider submits the amendment to the Secretary. The training provider may continue to provide training at the new permanent training location if the Secretary approves the amendment or does not disapprove the amendment within 30 days.

3.11 Inspections. To execute reasonable inspections and ensure compliance with these regulations, the Secretary has the authority to enter premises or facilities where certified firms and training programs conduct business and training programs.

**History**
- *16 DE Reg. 537 (11/01/12)*
- *26 DE Reg. 697 (02/01/23)*
- *16 DE Reg. 537 (11/01/12)*
- *26 DE Reg. 697 (02/01/23)*
- *27 DE Reg. 766 (04/01/24)*
- *16 DE Reg. 537 (11/01/12)*
- *26 DE Reg. 697 (02/01/23)*
- *27 DE Reg. 766 (04/01/24)*
- *16 DE Reg. 537 (11/01/12)*
- *26 DE Reg. 697 (02/01/23)*
- *27 DE Reg. 766 (04/01/24)*
- *16 DE Reg. 537 (11/01/12)*
- *26 DE Reg. 697 (02/01/23)*
- *27 DE Reg. 766 (04/01/24)*
- *11 DE Reg. 759 (12/01/07)*
- *16 DE Reg. 537 (11/01/12)*
- *26 DE Reg. 697 (02/01/23)*
- *27 DE Reg. 766 (04/01/24)*

##### **16 Del. Admin. Code § 4459-4.0** Certification of Individuals and Firms Engaged in Lead-Based Paint Activities {#sec-4459-4.0 omnilex-key=us-de-regs-official--title-16--4459-4.0}

4.1 Certification of individuals.

4.1.1 Individuals seeking certification to engage in lead-based paint activities must either:

4.1.1.1 Submit to the Secretary, an application demonstrating that they meet the requirements established in subsections 4.2 and 4.3 for the particular discipline for which certification is sought; or

4.1.1.2 Pass the appropriate State of Delaware certification examination and submit to the Secretary, an application that includes:

4.1.1.2.1 A copy of a valid lead-based paint activities certification (or equivalent) from a State or Tribal program that has been authorized by the EPA;

4.1.1.2.2 A digital photo of the applicant; and

4.1.1.2.3 The associated certification fee.

4.1.2 Following the submission of an application demonstrating that all the requirements of this section have been met, the Secretary shall certify an applicant as an Inspector, Risk Assessor, Supervisor, Project Designer, or Abatement Worker, as appropriate.

4.1.3 Upon receiving certification from the Secretary, individuals conducting lead-based paint activities shall comply with the work practice standards for performing the appropriate lead-based paint activities as established in Section 5.0 of these regulations.

4.1.4 It shall be a violation of the work practice standards for conducting lead-based paint activities for an individual to conduct any of the lead-based paint activities described in Section 5.0 if that individual has not been certified by the Secretary pursuant to this section to do so.

4.1.5 An individual certified outside of Delaware as an Abatement Worker under a jurisdiction with which Delaware does not have reciprocity (see subsection 6.3) may apply for provisional certification for a period of 1 year provided the individual's certification is issued through an EPA-approved training course and approved provider.

4.2 Discipline Requirements.

4.2.1 To become certified as an Inspector, Risk Assessor, or Supervisor an individual must:

4.2.1.1 Successfully complete an accredited course in the appropriate discipline and receive a course completion certificate from an accredited training provider;

4.2.1.2 Pass the certification examination in the appropriate discipline; and,

4.2.1.3 Meet or exceed the following experience and education requirements:

4.2.1.3.1 Inspectors. No additional experience or education requirements.

4.2.1.3.2 Risk Assessors.

4.2.1.3.2.1 Successful completion of an accredited training course for Inspectors; and

4.2.1.3.2.2 Bachelor's degree and 1 year of experience in a related field (e.g., lead, asbestos, environmental remediation work, or construction), or an associate’s degree with 2 years’ experience in a related field; or

4.2.1.3.2.3 Certification as an industrial hygienist, professional engineer, registered architect or certification in a related engineering/health/environmental field (e.g. safety professional, environmental scientist); or

4.2.1.3.2.4 A high school diploma (or equivalent), and at least 3 years of experience in a related field (e.g. lead, asbestos, environmental remediation work or construction).

4.2.1.3.3 Supervisor.

4.2.1.3.3.1 One year of experience as meeting the standards of a certified lead-based paint Abatement Worker; or

4.2.1.3.3.2 At least 2 years of experience in a related field (e.g., lead, asbestos, or environmental remediation work) or in the building trades.

4.2.2 To become certified as an Abatement Worker or Project Designer an individual must:

4.2.2.1 Successfully complete an accredited course in the appropriate discipline and receive a course completion certificate from an accredited training provider; and

4.2.2.2 Meet or exceed the following experience and education requirements:

4.2.2.2.1 Abatement Workers. No additional experience or education requirements.

4.2.2.2.2 Project Designers.

4.2.2.2.2.1 Successful completion of an accredited training course for Supervisors.

4.2.2.2.2.2 Bachelor's degree in engineering, architecture, or a related profession, and 1 year of experience in building construction and design or a related field; or,

4.2.2.2.2.3 Four years of experience in building construction and design or a related field.

4.2.3 The following documents shall be recognized by the Secretary as evidence of meeting the requirements listed in subsection 4.2:

4.2.3.1 Official academic transcripts or diploma, as evidence of meeting the education requirements.

4.2.3.2 Resumes, letters of reference, or documentation of work experience, as evidence of meeting the work experience requirements.

4.2.3.3 Course completion certificates from lead-specific or other related training courses, issued by accredited training programs, as evidence of meeting the training requirements.

4.2.4 In order to take the certification examination for a particular discipline an individual must:

4.2.4.1 Successfully complete an accredited course in the appropriate discipline and receive a course completion certificate from an accredited training provider.

4.2.4.2 Meet or exceed the education and experience requirements in subsections 4.2.1 and 4.2.2.

4.2.5 After passing the appropriate certification examination (if required); submitting an application demonstrating that the individual meets the appropriate training, education, and experience prerequisites described in subsections 4.2.1 and 4.2.2; signing a statement that certified individuals must permit the Secretary access to enter premises or facilities where the certified individual conducts business, including work sites, to execute reasonable inspection, including taking samples, to ensure compliance with regulations; and paying the associated fee, an individual shall be issued a certificate by the Secretary. To maintain certification, an individual must be re-certified as described in subsection 4.4.

4.2.6 An individual may take the certification examination for a lead inspector, risk assessor or supervisor no more than 2 times within 6 months of the date of the initial accredited program course test for that discipline.

4.2.7 If an individual does not pass the certification examination for a lead inspector, risk assessor or supervisor within 6 months of the date of the initial accredited program course test, the individual must retake the appropriate course from an accredited training program before reapplying for certification.

4.3 Re-Certification of Individuals.

4.3.1 Except as provided in subsection 4.3.2, to maintain certification in a particular discipline, a certified individual shall apply to and be re-certified by the Secretary in that discipline within 2 years from the date of successful completion of the initial or refresher training course, as applicable.

4.3.2 An individual may apply to and be recertified by the Secretary during the 6-month period following certification expiration only if the individual has not performed any lead-based paint activities authorized by that certification after the date that the certification expired.

4.3.3 An individual shall be re-certified if the individual successfully completes the appropriate accredited refresher training course, submits a valid copy of the appropriate refresher course completion certificate, signs a statement that certified individuals must permit the Secretary access to enter premises or facilities where the certified individual performs lead-based paint activities, including work sites, to execute reasonable inspection, including taking samples, to ensure compliance with regulations, and pays the associated fee.

4.3.4 An individual may maintain re-certification for multiple disciplines by successfully completing the appropriate highest discipline accredited refresher training course and meeting the experience and education parameters defined in subsection 4.2 for those disciplines.

4.4 Certification of firms.

4.4.1 All firms which perform or offer to perform any of the lead-based paint activities described in Section 5.0 shall be certified by the Secretary.

4.4.2 A firm seeking certification shall submit to the Secretary, the required fee, a certification application, and a letter attesting the following:

4.4.2.1 The firm shall only employ appropriately certified employees to conduct lead-based paint activities;

4.4.2.2 The firm and its employees shall follow the work practice standards in Section 5.0 for conducting lead-based paint activities; and

4.4.2.3 The firm and its employees shall permit the Secretary access to enter premises or facilities where the certified firm conducts business, including work sites, to execute reasonable inspection, including taking samples, to ensure compliance with regulations.

4.4.3 From the date of receiving the firm's certification application, letter, and the associated fee, the Secretary shall have 45 days to approve or disapprove the firm's request for certification. Within that time, the Secretary shall respond with either a certificate of approval or a letter describing the reasons for disapproval.

4.4.4 The firm shall maintain all records pursuant to requirements in Section 5.0.

4.4.5 Firms shall apply to the Secretary for certification to engage in lead-based paint activities.

4.4.6 Combined Renovation and Lead-Based Paint Activities Firm Applications will have no additional cost to the initial $550 Delaware certification fee for the Lead-Based Paint Activities Firm Applications.

4.5 Recertification of firms.

4.5.1 To maintain certification, a firm shall apply to and be re-certified by the Secretary every 2 years.

4.5.2 The recertification application shall be approved if it meets the requirements in subsection 4.4.2 and includes the appropriate fee.

4.6 Suspension, revocation, and modification of certifications of individuals engaged in lead-based-paint activities.

4.6.1 The Secretary may, after notice and opportunity for hearing, suspend, revoke, or modify an individual's certification if an individual has:

4.6.1.1 Obtained training documentation through fraudulent means.

4.6.1.2 Gained admission to and completed an accredited training program through misrepresentation of admission requirements.

4.6.1.3 Obtained certification through misrepresentation of certification requirements or related documents dealing with education, training, professional registration, or experience.

4.6.1.4 Performed work requiring certification at a job site without having proof of certification.

4.6.1.5 Permitted the duplication or use of the individual's own certificate by another.

4.6.1.6 Performed work for which appropriate certification has not been received.

4.6.1.7 Failed to comply with the appropriate work practice standards for lead-based paint activities in Section 5.0.

4.6.1.8 Failed to comply with Federal, State of Delaware or local lead-based paint statutes or regulations.

4.6.1.9 Denied the Secretary access to enter premises or facilities where the certified individual conducts business, including work sites, to execute reasonable inspection, including taking samples, to ensure compliance with regulations.

4.6.2 In addition to an administrative or judicial finding or violation, for purposes of this section only, execution of a consent agreement in settlement of an enforcement action constitutes evidence of a failure to comply with relevant statutes or regulations.

4.7 Suspension, revocation, and modification of certification of firms engaged in lead-based paint activities.

4.7.1 The Secretary may, after notice and opportunity for hearing, suspend, revoke, or modify a firm's certification if a firm has:

4.7.1.1 Performed work requiring certification at a job site with individuals who are not certified.

4.7.1.2 Failed to comply with the work practice standards established in Section 5.0.

4.7.1.3 Misrepresented facts in its certification application or letter.

4.7.1.4 Failed to maintain required records.

4.7.1.5 Failed to comply with Federal, State of Delaware, or local lead-based paint statutes or regulations.

4.7.1.6 Denied the Secretary access to enter premises or facilities where the certified firm conducts business, including work sites, to execute reasonable inspection, including taking samples, to ensure compliance with regulations.

4.7.2 In addition to an administrative or judicial finding of violation, for purposes of this section only, execution of a consent agreement in settlement of an enforcement action constitutes evidence of a failure to comply with relevant statutes or regulations.

4.8 Procedures for suspension, revocation, or modification of the certification of individuals or firms.

4.8.1 Prior to taking action to suspend, revoke, or modify the certification of any individual or firm, the Secretary shall notify the affected entity in writing of the following:

4.8.1.1 The legal and factual basis for the suspension, revocation, or modification.

4.8.1.2 The anticipated commencement date and duration of the suspension, revocation, or modification.

4.8.1.3 Actions, if any, which the affected entity may take to avoid suspension, revocation, or modification or to receive certification in the future.

4.8.1.4 The opportunity and method for requesting a hearing prior to final action to suspend, revoke, or modify certification.

4.8.1.5 Any additional information which the Secretary may provide.

4.8.2 If a hearing is requested by the certified individual or firm, the Secretary shall:

4.8.2.1 Provide the affected entity an opportunity to offer written statements in response to the Secretary's assertions of the legal and factual basis for its proposed action, and any other explanations, comments, and arguments it deems relevant to the proposed action.

4.8.2.2 Provide the affected entity such other procedural opportunities as the Secretary may deem appropriate to ensure a fair and impartial hearing.

4.8.2.3 Appoint an official Hearing Officer. No person shall serve as Hearing Officer if the person has had any prior involvement with the specific matter.

4.8.3 The Hearing Officer appointed pursuant to subsection 4.8.2.3 shall:

4.8.3.1 Conduct a fair, orderly, and impartial hearing within 90 days of the request for a hearing.

4.8.3.2 Consider all relevant evidence, explanation, comment, and argument submitted.

4.8.3.3 Notify the Secretary in writing within 45 days of completion of the hearing of the Hearing Officer's decision. The Secretary shall either accept or reject the decision. If accepted, the Secretary issues a final order within 45 of receiving the Hearing Officer’s decision. Such an order is a final agency action, which may be subject to judicial review.

4.8.4 If the Secretary determines that the public health, interest, or welfare warrants immediate action, to suspend the certification of any individual or firm, or if an individual or firm denies the Secretary access for purposes of inspection or taking samples, prior to the opportunity for a hearing, the Secretary shall:

4.8.4.1 Notify the affected entity of its intent to immediately suspend certification for the reasons listed in subsections 4.6.1 or 4.7.1. If a suspension, revocation, or modification notice has not previously been issued pursuant to subsection 4.8.1, it shall be issued at the same time the immediate suspension notice is issued.

4.8.4.2 Notify the affected entity in writing of the grounds upon which the immediate suspension is based and why it is necessary to suspend the entity's certification before an opportunity for a hearing to suspend, revoke, or modify the individual's or firm's certification.

4.8.4.3 Notify the affected entity of the commencement date and duration of the immediate suspension.

4.8.4.4 Notify the affected entity of its right to request a hearing on the immediate suspension within 15 days of the suspension taking place and the procedures for the conduct of such a hearing.

4.8.5 Any notice, decision, or order issued by the Secretary under this section, any transcripts or other verbatim record of oral testimony, and any documents filed by a certified individual or firm in a hearing under this section shall be available to the public. Any such hearing at which oral testimony is presented shall be open to the public, except that the Hearing Officer may exclude the public to the extent necessary to allow presentation of information which may be entitled to confidential treatment.

4.9 To execute reasonable inspections, including taking samples, and ensure compliance with these regulations, the Secretary has the authority to enter premises where certified firms and certified individuals conduct business and perform work.

**History**
- *16 DE Reg. 537 (11/01/12)*
- *26 DE Reg. 697 (02/01/23)*
- *16 DE Reg. 537 (11/01/12)*
- *26 DE Reg. 697 (02/01/23)*
- *27 DE Reg. 766 (04/01/24)*
- *16 DE Reg. 537 (11/01/12)*
- *26 DE Reg. 697 (02/01/23)*
- *27 DE Reg. 766 (04/01/24)*
- *16 DE Reg. 537 (11/01/12)*
- *26 DE Reg. 697 (02/01/23)*
- *27 DE Reg. 766 (04/01/24)*
- *16 DE Reg. 537 (11/01/12)*
- *26 DE Reg. 697 (02/01/23)*
- *27 DE Reg. 766 (04/01/24)*
- *11 DE Reg. 759 (12/01/07)*
- *16 DE Reg. 537 (11/01/12)*
- *26 DE Reg. 697 (02/01/23)*
- *27 DE Reg. 766 (04/01/24)*

##### **16 Del. Admin. Code § 4459-5.0** Work Practice Standards for Conducting Lead-Based Paint Activities: Target Housing and Child-Occupied Facilities {#sec-4459-5.0 omnilex-key=us-de-regs-official--title-16--4459-5.0}

5.1 Effective date, applicability, and terms.

5.1.1 All lead-based paint activities shall be performed pursuant to the work practice standards contained in this section.

5.1.2 When performing any lead-based paint activity described by a certified firm or a certified individual as an inspection, lead-hazard screen, risk assessment or abatement, a certified individual must perform that activity in compliance with the appropriate requirements below.

5.1.3 Documented methodologies that are appropriate for this section are found in the following: The U. S. Department of Housing and Urban Development (HUD) Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing; the EPA Guidance on Residential Lead-based Paint, Lead Contaminated Dust, and Lead-Contaminated Soil; the EPA Residential Sampling for Lead: Protocols for Dust and Soil Sampling (EPA report number 747-R-95-001); 40 CFR Part 745 subpart D – Lead Based Paint Hazards; and other methods and guidelines deemed equivalent by EPA or HUD.

5.1.4 Determinations.

5.1.4.1 Lead-based paint is present:

5.1.4.1.1 On any surface that is tested and found to contain lead equal to or in excess of 1.0 milligrams per square centimeter or equal to or in excess of 0.5% by weight; and

5.1.4.1.2 On any surface like a surface tested in the same room equivalent that has a similar painting history and that is found to be lead-based paint.

5.1.4.2 A paint-lead hazard is present:

5.1.4.2.1 On any friction surface that is subject to abrasion and where the lead dust levels on the nearest horizontal surface underneath the friction surface (e.g., the windowsill or floor) are equal to or greater than the dust hazard levels identified in subsection 5.6.8.8.

5.1.4.2.2 On any chewable lead-based paint surface on which there is evidence of teeth marks;

5.1.4.2.3 Where there is any damaged or otherwise deteriorated lead-based paint on an impact surface that is caused by impact from a related building component (such as a door knob that knocks into a wall or a door that knocks against its door frame); and

5.1.4.2.4 If there is any other deteriorated lead-based paint in any residential building or child-occupied facility or on the exterior of any residential building or child-occupied facility.

5.1.4.3 A dust-lead hazard is present in a residential dwelling or child occupied facility:

5.1.4.3.1 In a residential dwelling on floors and interior windowsills when the weighted arithmetic mean lead loading for all single surface or composite samples of floors and interior windowsills is equal to or greater than 10 µg/ft2 for floors and 100 µg/ft2 for interior windowsills, respectively;

5.1.4.3.2 On floors or interior windowsills in an unsampled residential dwelling in a multi-family dwelling, if a dust-lead hazard is present on floors or interior windowsills, respectively, in at least 1 sampled residential unit on the property; and

5.1.4.3.3 On floors or interior windowsills in an unsampled common area in a multi-family dwelling, if a dust-lead hazard is present on floors or interior windowsills, respectively, in at least 1 sampled common area in the same common area group on the property.

5.1.4.4 A soil-lead hazard is present:

5.1.4.4.1 In a play area when the soil-lead concentration from a composite play area sample of bare soil is equal to or greater than 400 parts per million; or

5.1.4.4.2 In the rest of the yard when the arithmetic mean lead concentration from a composite sample (or arithmetic mean of composite samples) of bare soil from the rest of the yard (i.e., non-play areas) for each residential building on a property is equal to or greater than 1,200 parts per million.

5.1.5 Clearance levels that are appropriate for the purposes of this section may be found listed in subsection 5.6.8.8; in the EPA Guidance on Residential Lead-based Paint, Lead-Contaminated Dust, and Lead Contaminated Soil; or other methods and guidelines deemed equivalent by the EPA or HUD.

5.2 Inspection.

5.2.1 An inspection shall be conducted only by a person certified by the Secretary as an Inspector or Risk Assessor and, if conducted, must be conducted according to the procedures in this section.

5.2.2 When conducting an inspection, the following locations shall be selected according to documented methodologies listed in subsection 5.1 and tested for the presence of lead-based paint:

5.2.2.1 In a residential dwelling and child-occupied facility, each component with a distinct painting history and each exterior component with a distinct painting history shall be tested for lead-based paint, except those components that the Inspector or Risk Assessor determines to have been replaced after 1978, or not to contain lead-based paint; and

5.2.2.2 In a multi-family dwelling and in a child-occupied facility, in addition to the requirements of subsection 5.2.1, each component in every common area with a distinct painting history, except those components that the Inspector or Risk Assessor determines to have been replaced after 1978, or to not contain lead-based paint.

5.2.3 Paint shall be sampled in the following manner:

5.2.3.1 The analysis of paint to determine the presence of lead shall be conducted using documented methodologies listed in subsection 5.1, which incorporate adequate quality control procedures; and

5.2.3.2 All collected paint chip samples shall be analyzed according to subsection 5.7 to determine if they contain detectable levels of lead that can be quantified numerically.

5.2.4 The certified Inspector or Risk Assessor shall prepare an inspection report which shall include the following information:

5.2.4.1 Date of each inspection.

5.2.4.2 Address of building.

5.2.4.3 Date of construction.

5.2.4.4 Apartment numbers (if applicable).

5.2.4.5 Name, address, and telephone number of the owner or owners of each residential dwelling or child-occupied facility.

5.2.4.6 Name, signature, and certification number of each certified Inspector or Risk Assessor conducting testing.

5.2.4.7 Name, address and telephone number of the certified firm employing each Inspector or Risk Assessor, if applicable.

5.2.4.8 Each testing method, device, and sampling procedure employed for paint analysis, including quality control data and, if used, the serial number of any x- ray fluorescence (XRF) device.

5.2.4.9 Specific locations of each painted component tested for the presence of lead-based paint.

5.2.4.10 The results of the inspection expressed in terms appropriate to the sampling method used.

5.3 Lead hazard screen.

5.3.1 A lead hazard screen shall be conducted only by a person certified by the Secretary as a Risk Assessor.

5.3.2 If conducted, a lead hazard screen shall be conducted as follows:

5.3.2.1 Background information regarding the physical characteristics of the residential dwelling or a child-occupied facility and occupant use patterns that may cause lead-based paint exposure to 1 or more children aged 6 years and under shall be collected.

5.3.2.2 A visual inspection of a residential dwelling or a child-occupied facility shall be conducted to:

5.3.2.2.1 Determine if any deteriorated paint is present, and

5.3.2.2.2 Locate at least 2 dust sampling locations in areas frequently used by children.

5.3.2.3 If deteriorated paint is present, each surface with deteriorated paint, determined using documented methodologies listed in subsection 5.1, to be in poor condition and to have a distinct painting history, shall be tested for the presence of lead.

5.3.2.4 In residential dwellings, 2 (either composite or single surface) dust wipe samples shall be collected, 1 from the floors and the other from the windows, in rooms, hallways, and stairwells where 1 or more children aged 6 and under are most likely to come in contact with dust.

5.3.2.5 In multi-family dwellings and in child-occupied facilities, in addition to the floor and window samples required in subsection 5.3.2.4, the Risk Assessor shall collect composite or single surface dust wipe samples from common areas where 1 or more children aged 6 and under are most likely to come into contact with dust.

5.3.2.6 If composite dust wipe samples identify lead hazards, additional single surface dust wipe samples will be necessary to determine where the lead hazards are located.

5.3.3 Dust wipe samples shall be collected and analyzed in the following manner:

5.3.3.1 All dust wipe samples shall be taken using documented methodologies listed in subsection 5.1 that incorporate adequate quality control procedures.

5.3.3.2 All collected dust wipe samples shall be analyzed according to subsections 5.6 and 5.7 to determine if they contain detectable levels of lead that can be quantified numerically.

5.3.4 Paint shall be sampled in the following manner:

5.3.4.1 The analysis of paint to determine the presence of lead shall be conducted using documented methodologies listed in subsection 5.1 that incorporate adequate quality control procedures; and

5.3.4.2 All collected paint chip samples shall be analyzed according to subsection 5.7 to determine if they contain detectable levels of lead that can be quantified numerically.

5.3.5 The Risk Assessor shall prepare a lead hazard screen report, which shall include the following information:

5.3.5.1 The information required in a risk assessment report as specified in subsection 5.4, including subsections 5.4.11.1 through 5.4.11.14, and excluding subsections 5.4.11.15 through 5.4.11.18. Additionally, any background information collected pursuant to subsection 5.3.2.1 shall be included in the risk assessment report; and

5.3.5.2 Recommendations, if warranted, for a follow-up risk assessment, and as appropriate, any further actions.

5.4 Risk assessment.

5.4.1 A risk assessment shall be conducted only by a person certified by the Secretary as a Risk Assessor and, if conducted, must be conducted according to the procedures in this paragraph.

5.4.2 A visual inspection for risk assessment of the residential dwelling or a child-occupied facility shall be undertaken to locate the existence of deteriorated paint, assess the extent and causes of the deterioration, and locate other potential lead-based paint hazards.

5.4.3 Background information regarding the physical characteristics of the residential dwelling or the child-occupied facility and occupant use patterns that may cause lead-based paint exposure to 1 or more children aged 6 years and under shall be collected.

5.4.4 The following surfaces which are determined, using documented methodologies, to have a distinct painting history, shall be tested for the presence of lead:

5.4.4.1 Each friction surface or impact surface with visibly deteriorated paint and

5.4.4.2 All other surfaces with visibly deteriorated paint.

5.4.5 In residential dwellings, dust wipe samples (either composite or single surface samples) from the interior windowsills and floor shall be collected and analyzed for lead concentration in all living areas where 1 or more children aged 6 and under are most likely to come into contact with dust.

5.4.6 For multi-family dwellings and child-occupied facilities, in addition to the requirements of subsection 5.4.5, interior windowsills and floor dust wipe samples (either composite or single surface samples) shall be collected and analyzed for lead concentration in the following locations:

5.4.6.1 Common areas adjacent to the sampled residential dwelling and child-occupied facility; and

5.4.6.2 Other common areas in the building where the Risk Assessor determines that 1 or more children aged 6 and under are likely to come into contact with dust.

5.4.7 For child-occupied facilities, interior windowsills and floor dust wipe samples (either composite or single surface samples) shall be collected and analyzed for lead concentration in each room, kitchen, hallway, and stairwell utilized by 1 or more children aged 6 and under, and in other common areas in the child-occupied facility where the Risk Assessor determines 1 or more children aged 6 and under are likely to come into contact with dust.

5.4.8 Soil samples shall be collected and analyzed for lead concentrations in the following locations:

5.4.8.1 Exterior play areas where bare soil is present;

5.4.8.2 Dripline/foundation areas where bare soil is present; and

5.4.8.3 Non-play areas where bare soil is present.

5.4.9 Any paint, dust, or soil sampling or testing shall be conducted using documented methodologies listed in subsections 5.1 and 5.6 that incorporate adequate quality control procedures.

5.4.10 Any collected paint chip, dust or soil samples shall be analyzed according to subsection 5.7 to determine if they contain detectable levels of lead that can be quantified numerically.

5.4.11 The certified Risk Assessor shall prepare a risk assessment report which shall include the following information:

5.4.11.1 Date of assessment.

5.4.11.2 Address of each building.

5.4.11.3 Date of construction of each building.

5.4.11.4 Apartment number (if applicable).

5.4.11.5 Name, address, and telephone number of each owner of each building.

5.4.11.6 Name, signature, and State of Delaware certification number of the certified Risk Assessor conducting the assessment.

5.4.11.7 Name, address, and telephone number of the certified firm employing each certified risk assessor, if applicable.

5.4.11.8 Name, address, and telephone number of each recognized laboratory conducting analysis of collected samples, if applicable.

5.4.11.9 Results of the visual inspection.

5.4.11.10 Testing method and sampling procedure for paint analysis employed.

5.4.11.11 Specific locations of each painted component tested for the presence of lead.

5.4.11.12 All data collected from on-site testing, including quality control data and, if used, the serial number of any XRF device.

5.4.11.13 All results of laboratory analysis on collected paint, soil, and dust wipe samples.

5.4.11.14 Any other sampling results.

5.4.11.15 Any background information collected pursuant to subsection 5.4.3.

5.4.11.16 To the extent that they are used as part of the lead-based paint hazard determination, the results of any previous inspections or analyses for the presence of lead-based paint, or other assessments of lead-based paint related hazards.

5.4.11.17 A description of the location, type, and severity of identified lead-based paint hazards and any other potential lead hazards.

5.4.11.18 A description of interim controls and abatement options for each identified lead-based paint hazard and a suggested prioritization for addressing each hazard. If the use of an encapsulant or enclosure is recommended, the report shall recommend a maintenance and monitoring schedule for the encapsulant or enclosure.

5.5 Interim Controls.

5.5.1 Interim controls of lead-based paint hazards identified in a risk assessment shall be conducted in accordance with the provisions of these regulations. Interim control measures include paint stabilization of deteriorated lead-based paint, treatments for friction and impact surfaces where levels of lead dust are above the levels specified in subsection 5.1.4.3.1, dust control, and lead-contaminated soil control. As provided by Section 2.0, interim controls may be performed in combination with, or be replaced by, abatement methods. If Lead Abatement activity and Interim Controls are to be performed at the same structure, the Abatement firm can perform both activities. In addition, individuals certified as RRP Renovator pursuant to 16 DE Admin. Code 4459B may perform the Interim Controls but may not perform lead abatement activities.

5.5.2 Paint stabilization.

5.5.2.1 Interim control treatments used to stabilize deteriorated lead-based paint shall be performed in accordance with the requirements of this section. Interim control treatments of intact, factory applied prime coatings on metal surfaces are not required. Finish coatings on such surfaces shall be treated by interim controls if those coatings contain lead-based paint.

5.5.2.2 Any physical defect in the substrate of a painted surface or component that is causing deterioration of the surface or component shall be repaired before treating the surface or component.

5.5.2.3 Before applying new paint, all loose paint and other loose material shall be removed from the surface to be treated. Acceptable methods for preparing the surface to be treated include wet scraping, wet sanding, and power sanding performed in conjunction with a HEPA filtered local exhaust attachment operated according to the manufacturer's instructions.

5.5.2.4 Dry sanding or dry scraping is permitted only in accordance with subsection 5.6.6.3 (i.e., for electrical safety reasons or for specified minor amounts of work).

5.5.2.5 Paint stabilization shall include the application of a new protective coating or paint. The surface substrate shall be dry and protected from future moisture damage before applying a new protective coating or paint. All protective coatings and paints shall be applied in accordance with the manufacturer's recommendations.

5.5.2.6 Paint stabilization shall incorporate the use of safe work practices in accordance with subsection 5.6.6.

5.5.3 Friction and impact surfaces.

5.5.3.1 Interim control treatments for friction surfaces shall eliminate friction points or treat the friction surface, so that paint is not subject to abrasion.

5.5.3.2 Interim control treatments for impact surfaces shall protect the paint from impact.

5.5.3.3 Interim control for impact or friction surfaces does not include covering such a surface with a coating or other treatment, such as painting over the surface, that does not protect lead-based paint from impact or abrasion.

5.6 Abatement.

5.6.1 An abatement shall be conducted only by a firm or an individual certified by the Secretary. Abatement shall be conducted according to the procedures in this section.

5.6.2 A certified Supervisor is required for each abatement project and shall be on site during all abatement work.

5.6.3 The certified Supervisor and the certified firm employing that supervisor, shall ensure that all abatement activities are conducted according to the requirements of these regulations and all other Federal, State of Delaware, and local requirements.

5.6.4 Written or electronic notification of the commencement of lead-based paint abatement activities, including but not limited to interim controls in target housing or a child-occupied facilities or as a result of a Federal, State of Delaware, or local order shall be given to the Secretary 5 business days prior to the commencement of abatement activities.

5.6.4.1 Notification for lead-based paint abatement activities and interim controls required in response to an elevated blood lead level (EBLL) determination, or Federal, State of Delaware, or local emergency abatement order should be received by the Secretary as early as possible before, but must be received no later than the start date of the lead-based paint abatement activities. Should the start date or location provided to the Secretary change, an updated notification must be received by the Secretary on or before the start date provided to the Secretary. Documentation showing evidence of an EBLL determination or a copy of the Federal/State of Delaware/local emergency abatement order must be included in the written or electronic notification to take advantage of this abbreviated notification period.

5.6.4.2 Except as provided in subsection 5.6.4.1, updated notification must be provided the Secretary for lead-based paint abatement activities and interim controls that will begin on a date other than the start date specified in the original notification, as follows:

5.6.4.2.1 For lead-based paint abatement activities and interim controls beginning prior to the start date provided to the Secretary an updated notification must be received by the Secretary at least 5 business days before the new start date included in the notification.

5.6.4.2.2 For lead-based paint abatement activities and interim controls beginning after the start date provided to the Secretary an updated notification must be received by the Secretary on or before the start date provided to the Secretary.

5.6.4.3 Except as provided in subsection 5.6.4.1, updated notification must be provided to the Secretary for any change in location of lead-based paint abatement activities at least 5 business days prior to the start date provided to the Secretary.

5.6.4.4 Updated notification must be provided to the Secretary when lead-based paint abatement activities and interim controls are canceled, or when there are other significant changes including, but not limited to, when the square footage or acreage to be abated changes by more than 20%. This updated notification must be received by the Secretary on or before the start date provided to the Secretary, or if work has already begun, within 24 hours of the change.

5.6.4.5 The following must be included in each notification:

5.6.4.5.1 Notification type (original, updated, cancellation).

5.6.4.5.2 Date when lead-based paint abatement activities or interim controls will start.

5.6.4.5.3 Date when lead-based paint abatement activities or interim controls will end (approximation using best professional judgment).

5.6.4.5.4 Firm's name, State of Delaware certification number, address, telephone number.

5.6.4.5.5 Type of building (e.g., single-family dwelling, multi-family dwelling, child-occupied facilities) on or in which abatement work or interim controls will be performed.

5.6.4.5.6 Property name (if applicable).

5.6.4.5.7 Property address including apartment or unit numbers (if applicable) for abatement work or interim controls.

5.6.4.5.8 Documentation showing evidence of an EBL determination or a copy of the Federal/State of Delaware/local emergency abatement order, if using the abbreviated time period as described in subsection 5.6.4.

5.6.4.5.9 Name and Delaware certification number of the project supervisor.

5.6.4.5.10 Approximate square footage/acreage to be abated.

5.6.4.5.11 Brief description of abatement activities to be performed.

5.6.4.5.12 Name, title, and signature of the representative of the certified firm who prepared the notification.

5.6.4.6 Notification must be accomplished using any of the following methods: Written or electronic. Written and electronic notifications of lead-based paint abatement activities and interim controls can be accomplished by using the guidance and sample form provided online at http://dhss.delaware.gov/dhss/dph/hsp/leadregcomm.html or similar form containing the information required in subsection 5.6.4.5. All written notifications must be delivered by U.S. Postal Service, fax, commercial delivery service, or hand delivery (persons submitting notification by U.S. Postal Service are reminded that they should allow 3 additional business days for delivery in order to ensure that the Secretary receives the notification by the required date).

5.6.4.7 Lead-based paint abatement activities and interim controls shall not begin on a date or at a location other than that specified in either an original or updated notification, in the event of changes to the original notification.

5.6.4.8 No firm or individual shall engage in lead-based paint abatement activities nor interim controls, as defined in Section 2.0, prior to notifying the Secretary of such activities according to the requirements of subsection 5.6.4.

5.6.5 A written occupant protection plan, or electronic equivalent, shall be developed for all abatement and interim control projects and shall be prepared according to the following procedures:

5.6.5.1 The occupant protection plan shall be unique to each residential dwelling or child-occupied facility and be developed prior to the abatement or interim control. The occupant protection plan shall describe the measures and management procedures that will be taken during the abatement or interim control to protect the building occupants from exposure to any lead-based paint hazards.

5.6.5.2 A certified Supervisor or Project Designer shall prepare the occupant protection plan.

5.6.6 The work practices listed below shall be restricted during an abatement or interim control as follows:

5.6.6.1 Open flame burning or torching of lead-based paint is prohibited;

5.6.6.2 Machine sanding or grinding or abrasive blasting or sandblasting of lead-based paint is prohibited unless used with High Efficiency Particulate Air (HEPA) exhaust control that removes particles of 0.3 microns or larger from the air at 99.97% or greater efficiency;

5.6.6.3 Dry scraping of lead-based paint is permitted only in conjunction with heat guns or around electrical outlets or when treating defective paint spots totaling no more than 2 square feet in any 1 room, hallway or stairwell, or totaling no more than 20 square feet on exterior surfaces; and

5.5.6.4 Operating a heat gun on lead-based paint is permitted only at temperatures below 1,100 degrees Fahrenheit.

5.6.7 If conducted, soil abatement shall be conducted in 1 of the following ways:

5.6.7.1 If soil is removed, the lead-contaminated soil shall be replaced with soil with a lead concentration as close to local background as practical, but not greater than 100 milligrams per kilogram.

5.6.7.2 If soil is not removed, the lead-contaminated soil shall be permanently covered, as defined in "Permanently covered soil".

5.6.7.3 Lead contaminated soil that is removed shall not be used as topsoil at other residential property or child-occupied facility and shall be disposed of in accordance with applicable Federal, State, and local requirements.

5.6.8 The following post-abatement or interim control clearance procedures shall be performed only by a certified Inspector or Risk Assessor:

5.6.8.1 Following an abatement or interim control, a visual inspection shall be performed to determine if deteriorated painted surfaces or visible amounts of dust, debris, or residue are present. If deteriorated painted surfaces or visible amounts of dust, debris, or residue are present, these conditions must be eliminated prior to the continuation of the clearance procedures.

5.6.8.2 Following the visual inspection and any post-abatement cleanup required by subsection 5.6.8.1, clearance sampling for lead-contaminated dust shall be conducted. Clearance sampling may be conducted by employing single surface sampling or composite sampling techniques.

5.6.8.3 Dust wipe samples for clearance purposes shall be taken using documented methodologies listed in subsection 5.1 that incorporate adequate quality control procedures.

5.6.8.4 Dust wipe samples for clearance purposes shall be taken a minimum of 1 hour after completion of final post-abatement or interim control cleanup activities.

5.6.8.5 The following post-abatement or interim control clearance activities shall be conducted as appropriate based upon the extent or manner of abatement or interim control activities conducted in or to a residential dwelling or a child-occupied facility:

5.6.8.5.1 After conducting an abatement or interim control with containment between work areas and nonwork areas:

5.6.8.5.1.1 Dust wipe samples shall be taken from no fewer than 4 rooms, hallways, and stairwells within the containment area. If there are fewer than 4 rooms, hallways, and stairwells within the containment area, then all rooms, hallways, and stairwells shall be sampled.

5.6.8.5.1.2 For each room, 1 dust wipe sample shall be taken from 1 interior windowsill, 1 dust wipe sample shall be taken from the floor and 1 dust wipe sample shall be taken from a window trough (if present). A window trough sample is not required if all windows within the containment area were closed and sealed with plastic during abatement activities.

5.6.8.5.1.3 In addition, 1 dust wipe sample shall be taken from the floor outside the containment area.

5.6.8.5.2 After conducting an abatement or interim control with no containment:

5.6.8.5.2.1 Dust wipe samples shall be taken from no fewer than 4 rooms, hallways, and stairwells in the residential dwelling or a child-occupied facility. If there are fewer than 4 rooms, hallways, or stairwells within the residential dwelling or child-occupied facility then all rooms, hallways, and stairwells shall be sampled.

5.6.8.5.2.2 For each room, 1 dust wipe sample shall be taken from 1 interior windowsill, 1 dust wipe sample shall be taken from the floor, and 1 dust wipe sample shall be taken from a window trough (if present). A window trough sample is not required if all windows were closed and sealed with plastic during abatement activities.

5.6.8.5.3 Following an exterior paint abatement or interim control a visible inspection shall be conducted. All horizontal surfaces in the outdoor living area closest to the abated surface shall be found to be cleaned of visible dust and debris. In addition, a visual inspection shall be conducted to determine the presence of paint chips on the dripline or next to the foundation below any exterior surface abated. If paint chips are present, they must be removed from the site and properly disposed of, according to all applicable Federal, State of Delaware, and local requirements.

5.6.8.6 The rooms, hallways, and stairwells selected for sampling shall be selected according to documented methodologies listed in subsection 5.1.

5.6.8.7 The certified Inspector or Risk Assessor shall compare the residual lead level (as determined by the laboratory analysis) from each single surface dust wipe sample with clearance levels in subsection 5.6.8.8 for lead in dust on floors, interior windowsills and window troughs or from each composite dust wipe sample with the applicable clearance levels for lead in dust on floors, interior windowsills, and window troughs divided by half the number of subsamples in the composite sample. If the residual lead level in a single surface dust wipe sample equals or exceeds the applicable clearance level or if the residual lead level in a composite dust wipe sample equals or exceeds the applicable clearance level divided by half the number of subsamples in the composite sample, the components represented by the failed sample shall be re-cleaned and retested.

5.6.8.8 The clearance levels for lead in dust are 10 µg/ft2 for floors, 100 µg/ft2 for interior windowsills, and 400 µg/ft2 for window troughs.

5.6.9 In a multi-family dwelling with similarly constructed and maintained residential dwellings, random sampling for the purposes of clearance may be conducted provided:

5.6.9.1 The certified individuals who abate or clean the residential dwellings do not know which residential dwelling will be selected for the random sample.

5.6.9.2 A sufficient number of residential dwellings are selected for dust sampling to provide a 95% level of confidence that no more than 5.0% or 50 of the residential dwellings (whichever is smaller) in the randomly sampled population exceed the appropriate clearance levels.

5.6.9.3 The randomly selected residential dwellings shall be sampled and evaluated for clearance according to the procedures found in subsection 5.6.8.

5.6.10 An abatement report shall be prepared and signed by a certified supervisor or project designer. The abatement report shall include the following information:

5.6.10.1 Start and completion dates of abatement.

5.6.10.2 The names and address of each certified firm conducting the abatement and the name of each Supervisor assigned to the abatement project.

5.6.10.3 The occupant protection plan prepared pursuant to subsection 5.6.5.

5.6.10.4 The name, address, and signature of each certified Risk Assessor or Inspector conducting a clearance sampling and the date of clearance testing.

5.6.10.5 The results of clearance testing and all soil analyses (if applicable) and the name of each recognized laboratory that conducted the analyses.

5.6.10.6 A detailed written report, or electronic equivalent, describing the abatement, including abatement methods used, locations of rooms and components where abatement occurred, reason for selecting particular abatement methods for each component, and any suggested monitoring of encapsulants or enclosures. The report shall also detail any deviations, changes or abnormalities from the original scope of work.

5.7 Collection and laboratory analysis of samples. Any paint, chip, dust, or soil samples collected pursuant to the work practice standards contained in this section shall be:

5.7.1 Collected by persons certified as an Inspector or Risk Assessor by the Secretary; and,

5.7.2 Analyzed by a recognized laboratory that is accredited and proficient to perform analyses for lead compounds in paint chip, dust, and soil samples.

5.8 Composite dust wipe sampling. Composite dust wipe sampling may only be conducted in the situations specified in 5.3 through 5.6. If such sampling is conducted, the following conditions shall apply:

5.8.1 Composite dust wipe samples shall consist of at least 2 sub-samples;

5.8.2 Every component that is being tested shall be included in the sampling; and

5.8.3 Composite dust wipe samples shall not consist of sub-samples from more than 1 type of component.

5.9 Record keeping. All reports or plans required in this section shall be maintained by the certified individual or firm, if any, who prepared the report for no fewer than 3 years and 6 months. The certified individual or firm also shall provide a copy of these reports to the building owner who contracted for its services.

5.10 Inspections. To ensure compliance with regulations, the Secretary has the authority to conduct inspections of and take samples at work sites and business premises of any firm or individual that conducts business in Delaware covered by these regulations.

5.11 Reporting. All reports or plans required in this section may become subject to quarterly reporting requirements as deemed necessary and appropriate by the Secretary after lawful notification.

**History**
- *16 DE Reg. 537 (11/01/12)*
- *26 DE Reg. 697 (02/01/23)*
- *16 DE Reg. 537 (11/01/12)*
- *26 DE Reg. 697 (02/01/23)*
- *27 DE Reg. 766 (04/01/24)*
- *16 DE Reg. 537 (11/01/12)*
- *26 DE Reg. 697 (02/01/23)*
- *27 DE Reg. 766 (04/01/24)*
- *16 DE Reg. 537 (11/01/12)*
- *26 DE Reg. 697 (02/01/23)*
- *27 DE Reg. 766 (04/01/24)*
- *16 DE Reg. 537 (11/01/12)*
- *26 DE Reg. 697 (02/01/23)*
- *27 DE Reg. 766 (04/01/24)*
- *11 DE Reg. 759 (12/01/07)*
- *16 DE Reg. 537 (11/01/12)*
- *26 DE Reg. 697 (02/01/23)*
- *27 DE Reg. 766 (04/01/24)*

##### **16 Del. Admin. Code § 4459-6.0** Certification, Fees, and Reciprocity {#sec-4459-6.0 omnilex-key=us-de-regs-official--title-16--4459-6.0}

6.1 Certification of Occupations and Accreditation of Other Training Programs.

6.1.1 Lead-based paint activities as defined by these regulations shall only be conducted according to the procedures and work practice standards contained in these regulations.

6.1.2 No individual or firm shall make offer to perform or perform any lead-based paint activity as defined by these regulations unless certified to perform that activity according to the procedures.

6.2 Fees.

6.2.1 Fees shall be remitted by certified check or money order and made payable to the Division of Public Health. Fees are not refundable.

6.2.2 The annual fee for an initial or a renewal of a certified Abatement Worker shall be $25.00.

6.2.3 The annual fee for an initial or a renewal of a Certified Firm, Supervisor, Project Designer, Lead Inspector and Risk Assessor shall be $50.00.

6.2.4 The annual fee for an initial or a renewal of an accredited training program shall be $200.00 for each type of course for which training will be provided. There is no fee for accreditation amendments.

6.2.5 Applicants who submit a dishonored check will be charged a service fee in addition to the required application fee that is in accordance with department policy.

6.3 Reciprocity. The Secretary may enter into reciprocal agreements with other states and jurisdictions that have been authorized by the EPA.

16 DE Reg. 537 (11/01/12)

26 DE Reg. 697 (02/01/23)

**History**
- *16 DE Reg. 537 (11/01/12)*
- *26 DE Reg. 697 (02/01/23)*
- *16 DE Reg. 537 (11/01/12)*
- *26 DE Reg. 697 (02/01/23)*
- *27 DE Reg. 766 (04/01/24)*
- *16 DE Reg. 537 (11/01/12)*
- *26 DE Reg. 697 (02/01/23)*
- *27 DE Reg. 766 (04/01/24)*
- *16 DE Reg. 537 (11/01/12)*
- *26 DE Reg. 697 (02/01/23)*
- *27 DE Reg. 766 (04/01/24)*
- *16 DE Reg. 537 (11/01/12)*
- *26 DE Reg. 697 (02/01/23)*
- *27 DE Reg. 766 (04/01/24)*
- *11 DE Reg. 759 (12/01/07)*
- *16 DE Reg. 537 (11/01/12)*
- *26 DE Reg. 697 (02/01/23)*
- *27 DE Reg. 766 (04/01/24)*

##### **16 Del. Admin. Code § 4459-7.0** Compliance and Enforcement Procedures {#sec-4459-7.0 omnilex-key=us-de-regs-official--title-16--4459-7.0}

7.1 General.

7.1.1 The failure or refusal to comply with any requirement of these regulations is a prohibited act.

7.1.2 The failure or refusal to establish, maintain, provide copy or permit access to records or reports as required in these regulations is a prohibited act.

7.1.3 The failure or refusal to permit entry or inspection as required by these regulations is a prohibited act.

7.1.4 In addition to the above, any individual or certified abatement firm that performs any of the following acts shall be deemed to have committed a prohibited act. These include but are limited to the following:

7.1.4.1 Obtaining certification through fraudulent representation.

7.1.4.2 Failing to obtain certification from the Secretary and performing work at a job site.

7.1.4.3 Fraudulently obtaining certification and engaging in any lead-based paint activity requiring certification.

7.2 Penalty. Violators are subject to sanctions pursuant to 16 Del.C. §107 for each violation of the requirements established in these regulations.

**History**
- *16 DE Reg. 537 (11/01/12)*
- *26 DE Reg. 697 (02/01/23)*
- *16 DE Reg. 537 (11/01/12)*
- *26 DE Reg. 697 (02/01/23)*
- *27 DE Reg. 766 (04/01/24)*
- *16 DE Reg. 537 (11/01/12)*
- *26 DE Reg. 697 (02/01/23)*
- *27 DE Reg. 766 (04/01/24)*
- *16 DE Reg. 537 (11/01/12)*
- *26 DE Reg. 697 (02/01/23)*
- *27 DE Reg. 766 (04/01/24)*
- *16 DE Reg. 537 (11/01/12)*
- *26 DE Reg. 697 (02/01/23)*
- *27 DE Reg. 766 (04/01/24)*
- *11 DE Reg. 759 (12/01/07)*
- *16 DE Reg. 537 (11/01/12)*
- *26 DE Reg. 697 (02/01/23)*
- *27 DE Reg. 766 (04/01/24)*

#### **4459A** Regulations Governing the Childhood Lead Poisoning Prevention Act

##### **16 Del. Admin. Code § 4459A-1.0** General Provisions {#sec-4459a-1.0 omnilex-key=us-de-regs-official--title-16--4459A-1.0}

Preamble. These regulations are adopted by the Secretary of Delaware Health and Social Services pursuant to 16 Del.C., §122(3)(t) and §§2601-2606. These regulations establish standards for blood lead level screening and testing of children between 12 and 24 months of age. These regulations also establish a record retention policy, enforcement modalities, and penalties for violators.

**History**
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *14 DE Reg. 570 (12/01/10)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*

##### **16 Del. Admin. Code § 4459A-2.0** Definitions {#sec-4459a-2.0 omnilex-key=us-de-regs-official--title-16--4459A-2.0}

For purposes of this chapter, the following definitions shall apply:

"Administer a blood lead level screening or test" means to draw a blood specimen, by either capillary or venous methodology, and:

(a) Send the specimen to a medical laboratory for blood lead analysis; or

(b) Conduct a blood lead analysis at a health care provider's office; or

(c) Order a blood specimen to be drawn by a third-party health care provider, by either venous or capillary methodology, and sent to a medical laboratory for blood lead analysis.

"Blood lead analysis" means the analysis and determination by a medical laboratory of the blood lead level in a blood specimen.

“Capillary” means a blood sample taken from the capillaries in the finger or heel for lead analysis.

"Child care facility" means any facility licensed by the Office of Child Care Licensing to provide child care services in Delaware.

“Division” means the Delaware Division of Public Health.

“Department” means the Delaware Department of Health and Social Services.

“Health care provider” means a licensed practitioner individual that generally provides medical care to a child including, but not limited to, a physician, a physician assistant, or a nurse, including a school nurse.

“Laboratory” means a laboratory certified to perform either waived or non-waived blood lead analysis according to the federal Clinical Laboratory Improvement Act of 1988 (CLIA).

"Parent or guardian" means an individual acting in a primary custodial capacity.

"Reference value" means the most current blood lead reference value as determined by the Centers for Disease Control and Prevention.

"Screening" means a capillary blood lead level test, including where a drop of blood is taken from a finger or heel of the foot.

"Testing" means a venous blood lead level test where blood is drawn from a vein.

“Venous” means a blood sample taken from a vein in the arm for lead analysis.

**History**
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *14 DE Reg. 570 (12/01/10)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*

##### **16 Del. Admin. Code § 4459A-3.0** Requirement for Blood Lead Level Screenings and Tests {#sec-4459a-3.0 omnilex-key=us-de-regs-official--title-16--4459A-3.0}

3.1 Pursuant to 16 Del.C. §2602(a), a primary health care provider for a child shall administer a blood screening or test for lead when the child is between 9 and 15 months of age and again between 21 and 27 months of age. Screenings or tests administered from 15 through 18 months of age shall be considered a 12-month screening or test, and from 18 through 21 months of age shall be considered a 24-month screening or test.

3.2 Unless a child's parent or guardian requests a blood lead level screening or test, a primary health care provider for a child who is 28 months old or older and younger than 18 years old shall administer a blood screening or test for lead in the following circumstances:

3.2.1 If the child has not previously received a blood lead level screening or test;

3.2.2 If the child's parent or guardian fails to provide documentation that the child has previously received a blood lead level screening or test; or

3.2.3 If the health care provider is unable to obtain the results of a previous blood lead analysis.

3.3 A health care provider shall administer a blood lead level test, by venous methodology, if the results of a capillary screening indicate a blood lead level result greater than or equal to the reference value.

3.4 A health care provider giving non-primary care to a child may administer a blood lead level screening or test, even if a blood lead level screening or test is not medically indicated.

3.5 If a child is insured under Delaware's Medicaid program, the child's primary health care provider shall administer a blood lead level screening or test to the child at the 12-month visit and again at the 24-month visit in accordance with Early and Periodic Screening, Diagnosis and Treatment (EPSDT) requirements.

3.6 In addition to the blood lead level screening and testing requirements in this section, a health care provider may order a lead screening or test at their discretion and these results must be reported to the Division pursuant to Section 7.0.

**History**
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *14 DE Reg. 570 (12/01/10)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*

##### **16 Del. Admin. Code § 4459A-4.0** [Reserved.] {#sec-4459a-4.0 omnilex-key=us-de-regs-official--title-16--4459A-4.0}

**History**
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *14 DE Reg. 570 (12/01/10)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*

##### **16 Del. Admin. Code § 4459A-5.0** Religious Exemption {#sec-4459a-5.0 omnilex-key=us-de-regs-official--title-16--4459A-5.0}

A religious exemption may be granted to a child if the blood lead level screening or testing conflicts with a genuine and sincere religious belief and not a belief based merely on philosophical, scientific, moral, personal, or medical opposition to blood lead level screening or testing. The Division affidavit of blood lead level screening or testing exemption for religious beliefs shall be signed and dated by the child’s parent or guardian, notarized, and kept in the child’s medical chart.

**History**
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *14 DE Reg. 570 (12/01/10)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*

##### **16 Del. Admin. Code § 4459A-6.0** Timeline for Valid Blood Lead Level Screening and Testing {#sec-4459a-6.0 omnilex-key=us-de-regs-official--title-16--4459A-6.0}

To be valid, a blood lead level screening or test shall be performed, as required by these regulations, on a child when the child is from 9 through 15 months of age and again from 21 through 27 months of age, pursuant to subsection 3.1. Children with blood lead levels above the reference value established by the Centers for Disease Control and Prevention must have a venous confirmation blood test if the original analysis was conducted through capillary screening.

**History**
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *14 DE Reg. 570 (12/01/10)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*

##### **16 Del. Admin. Code § 4459A-7.0** Blood Lead Level Screening and Testing Documentation and Reporting Requirements {#sec-4459a-7.0 omnilex-key=us-de-regs-official--title-16--4459A-7.0}

7.1 All laboratories and health-care providers involved in blood lead level analysis, including screening and testing, shall participate in a universal reporting system as established by the Division of Public Health.

7.2 The laboratory, health care provider's office, or other facility that administers a blood lead level screening or test for a child younger than 18 years old shall obtain the information required by this regulation at the time of drawing the blood specimen.

7.3 A laboratory that performs blood lead analysis shall provide a referral form of paper or electronic requisition that specifies the required information for use by a laboratory, a health care provider's office, or another facility that draws a blood specimen. The facility that draws a blood specimen shall:

7.3.1 Record the information required under this regulation on the laboratory's referral form or similar form; and

7.3.2 Forward the required information concurrently with the blood specimen to the laboratory that performs blood lead analysis.

7.4 A laboratory required to report a blood lead level screening or test under this regulation shall report the blood lead level screening or test in the format approved by the Division and shall include the following information:

7.4.1 The child's demographic information, including:

7.4.1.1 First name, middle initial, and last name;

7.4.1.2 Date of birth;

7.4.1.3 Country of birth;

7.4.1.4 Sex;

7.4.1.5 Race and ethnicity;

7.4.1.6 Master Client Index (MCI) number if the child is enrolled in Medicaid or a Delaware children's health program;

7.4.1.7 Complete home address at the time the blood specimen was drawn, including house or apartment number, street, city or town, county, zip code, and state;

7.4.1.8 Telephone number; and

7.4.1.9 Parent's or guardian's name.

7.4.2 Type of blood specimen, venous or capillary, and the blood draw date;

7.4.3 The health care provider's name, office name, address, telephone number, and national provider identifier (NPI);

7.4.4 If the draw site is different from the health care provider's office, the laboratory's or other facility's name, address, telephone number, and NPI;

7.4.5 All of the following information about the laboratory performing the blood lead analysis:

7.4.5.1 Laboratory name, address, telephone number, and clinical laboratory improvement amendment number (CLIA);

7.4.5.2 Laboratory method used to analyze the blood specimen;

7.4.5.3 The limit of detection for the method used to analyze the blood specimen; and

7.4.5.4 If reporting a "no result" screening or test result, the limit of detection for the laboratory method.

7.4.6 Blood lead level in micrograms per deciliter expressed with a numeric results comparator of:

7.4.6.1 Equal, if the blood lead level is an exact measurement; or

7.4.6.2 Less than or greater than, if a blood lead level reading is below or above a certain level that a device used to analyze a blood specimen can accurately record.

7.4.7 Additional information as may be required by the Division.

**History**
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *14 DE Reg. 570 (12/01/10)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*

##### **16 Del. Admin. Code § 4459A-8.0** Missing Information {#sec-4459a-8.0 omnilex-key=us-de-regs-official--title-16--4459A-8.0}

8.1 A laboratory that receives a blood specimen from a laboratory, a health care provider's office, or another facility without all the required information listed in Section 7.0 included on the referral form required under subsection 7.3 shall:

8.1.1 Within 3 business days of receipt of the blood specimen, send to the facility that provided the blood specimen a written or electronic message citing the requirements of this regulation, requesting that all the required missing information be forwarded to the laboratory; and

8.1.2 Upon receipt of the required information, collate and transmit the information to the Division within the time frames set forth in this regulation.

8.2 When the laboratory reports a blood lead level screening or test result to the Division with 1 or more of the requirements listed in Section 7.0 omitted, the laboratory shall concurrently provide the name and address of the facility that:

8.2.1 Drew the blood specimen; and

8.2.2 Failed upon request to forward the required information to the laboratory.

8.3 The facility that drew the blood specimen shall respond to a written or electronic message from a laboratory that did not receive all of the required information listed in Section 7.0 by providing the information to the laboratory within:

8.3.1 One business day of receiving the message regarding a blood lead level screening or test result of greater than or equal to the reference value;

8.3.2 Five business days of receiving the message for a blood lead level screening or test result of less than the reference value.

8.4 A laboratory not permitted to perform a blood lead analysis that accepts a blood specimen from a health care provider for referral to another laboratory for blood lead analysis shall ensure that:

8.4.1 The requisition record includes all the information that is required under this regulation; and

8.4.2 The required information is transmitted to the laboratory performing the blood lead analysis along with the blood specimen.

8.5 Reporting a blood lead level screening or test result with missing information:

8.5.1 A laboratory shall collate information required under Section 7.0 that is collected to complete a previously incomplete requisition record for a blood lead level screening or test before submitting the information to the Division in accordance with this regulation.

8.5.2 A laboratory shall report the missing information collated to the Division pursuant to this regulation:

8.5.2.1 Concurrently with the blood lead level screening or test result, if the reporting time frame for a blood lead level screening or test result established in subsection 8.3 has not concluded; or

8.5.2.2 In a manner indicating that there has been a change in the blood lead level screening or test record, if reporting the missing information after the initial blood lead level screening or test result was reported to the Division.

**History**
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *14 DE Reg. 570 (12/01/10)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*

##### **16 Del. Admin. Code § 4459A-9.0** Additional Reporting Requirements {#sec-4459a-9.0 omnilex-key=us-de-regs-official--title-16--4459A-9.0}

9.1 In addition to the reporting requirements set forth in Section 7.0, a laboratory shall report the result of a blood lead level screening or test to:

9.1.1 The health care provider that ordered the blood lead level screening or test; and

9.1.2 Another entity as required by State, federal, or local statutes or regulations, or in accordance with accepted standards of practice.

9.2 A laboratory shall report the result of a blood lead level screening or test to the Division by electronic system, facsimile, or other manner required by the Division within 2 weeks of a final blood lead level screening or test result.

9.3 A laboratory that uses an electronic system for tracking blood lead level screening or test results shall report a result to the Division electronically in a manner consistent with the technical specifications established by the Division.

**History**
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *14 DE Reg. 570 (12/01/10)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*

##### **16 Del. Admin. Code § 4459A-10.0** Proof of Documentation Requirements Prior to Child Care or School Enrollment {#sec-4459a-10.0 omnilex-key=us-de-regs-official--title-16--4459A-10.0}

10.1 Upon first admission or continued enrollment, the parent or guardian of a child 12 months of age or older shall provide to the child care facility, public or private nursery school, preschool, or kindergarten proof that the child received a blood lead level screening or test.

10.2 Except in the case of enrollment in kindergarten, the blood lead level screening or test may be done within 60 calendar days of the date of enrollment.

10.3 A child's parent or guardian must provide 1 of the following to a child care facility, public or private nursery school, preschool, or kindergarten:

10.3.1 A statement from the child's primary health care provider that the child has received the required screenings or tests for lead; or

10.3.2 The Division affidavit signed by the parent or guardian stating that the blood lead level screening or test is contrary to the parent's or guardian's religious beliefs; or

10.3.3 Certified documentation of the child's blood lead analysis, as specified in this regulation, administered in connection with the 12-month visit and 24-month visit to the child's health care provider not later than:

10.3.3.1 30 calendar days from the 12-month visit or 24-month visit; or

10.3.3.2 30 calendar days from first entry into the child care facility, public or private nursery school, preschool, or kindergarten.

10.4 If the child's first blood lead level screening or test was administered after the child is 28 months old, then only certified documentation of the most recent blood lead analysis is required to be reported.

10.5 If a child has more than 2 blood lead level screenings or tests administered from the ages of 9 months through 27 months then only certified documentation of the 2 most recent blood lead analyses shall be reported.

10.6 The information sent to or received by a child care facility, public or private nursery school, preschool, kindergarten or school shall be recorded and certified by a health care provider's signature on a form that includes the following:

10.6.1 Name of the child;

10.6.2 Date of the blood lead analysis; and

10.6.3 The signature of the child's primary health care provider or designee.

10.7 This Section shall apply to all children born after June 30, 2021.

**History**
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *14 DE Reg. 570 (12/01/10)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*

##### **16 Del. Admin. Code § 4459A-11.0** Division's Investigation and Reporting Obligations {#sec-4459a-11.0 omnilex-key=us-de-regs-official--title-16--4459A-11.0}

11.1 Within 60 days of receiving notification that a child has a blood lead level at or above the reference level, the Division shall determine: the child's residential address from birth through testing, the site of the child's lead exposure, and the property owner of the site at which the child became exposed to lead. Any documents that the Division creates or holds that contain confidential health information shall be conspicuously marked and will not become public documents.

11.2 Within 10 days of identifying the site of lead exposure, the Division shall notify the Delaware State Lead-Based Paint Program, created by 16 Del.C. §2607, of the location and contact information of the property owner. These communications will be public records subject to disclosure under the Freedom of Information Act, Delaware Code, Title 29, Chapter 100.

**History**
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *14 DE Reg. 570 (12/01/10)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*

##### **16 Del. Admin. Code § 4459A-12.0** Severability {#sec-4459a-12.0 omnilex-key=us-de-regs-official--title-16--4459A-12.0}

If any provision or application of any provision of these regulations is held invalid, that invalidity shall not affect the validity of other provisions or applications of these regulations.

**History**
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *14 DE Reg. 570 (12/01/10)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*

##### **16 Del. Admin. Code § 4459A-13.0** Penalty {#sec-4459a-13.0 omnilex-key=us-de-regs-official--title-16--4459A-13.0}

Violators are subject to sanctions pursuant to 16 Del.C. §107 for each violation of the requirements established in these regulations.

**History**
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 864 (05/01/24)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*
- *14 DE Reg. 570 (12/01/10)*
- *27 DE Reg. 109 (08/01/23)*
- *27 DE Reg. 864 (05/01/24)*

#### **4459B** Residential Property Renovation, Repair and Painting

##### **16 Del. Admin. Code § 4459B-1.0** General Provisions {#sec-4459b-1.0 omnilex-key=us-de-regs-official--title-16--4459B-1.0}

1.1 Preamble. These regulations are adopted by the Secretary of Delaware Health and Social Services pursuant to the Authority invested in the Secretary by 16 Del.C. §122(3)t. These regulations apply to all renovations performed for compensation in target housing and child-occupied facilities.

1.2 Purpose. These regulations shall be construed and applied to promote their underlying purpose of protecting the public health. The purpose of these regulations is to ensure the following:

1.2.1 Owners and occupants of target housing and child-occupied facilities receive information on lead-based paint hazards before these renovations begin;

1.2.2 Individuals performing renovations regulated in accordance with subsection 1.5 of these regulations are properly trained;

1.2.3 Renovators and firms performing these renovations are certified; and

1.2.4 The work practices in Section 3.0 are followed during these renovations.

1.3 Severability. If any provision or application of any provision of these regulations is held invalid, that invalidity shall not affect other provisions or applications of these regulations.

1.4 Effective Dates

1.4.1 Training programs. On or after the effective date of these regulations, it shall be unlawful for any training program to provide, offer, or claim to provide training or refresher training for certification as a Renovator or a Dust Wipe Technician without first possessing accreditation from the Secretary under Section 11.0. Training programs accredited by EPA as of the effective date of these regulations shall be deemed accredited only:

1.4.1.1 Through the expiration date of that EPA certification; and

1.4.1.2 Upon the Secretary’s receipt of documentation of that EPA certification.

1.4.2 Firms. On or after the effective date of these regulations, it shall be unlawful for any firm to perform, offer, or claim to perform renovations in target housing or child-occupied facilities without certification from the Secretary under Section 7.0, unless the renovation qualifies for 1 of the exceptions identified in subsections 1.5.1 and 1.5.2. A firm certified by EPA as of the effective date of these regulations shall be deemed certified only:

1.4.2.1 Through the expiration date of that EPA certification; and

1.4.2.2 Upon the Secretary’s receipt of documentation of that EPA certification.

1.4.3 Individuals. On or after the effective date of these regulations, all renovations in target housing or child-occupied facilities must be directed by Renovators certified by the Secretary in accordance with subsection 8.1 and performed by certified Renovators, or individuals trained in accordance with subsection 8.2.2, unless the renovation qualifies for 1 of the exceptions identified in subsections 1.5.1 and 1.5.2. An individual certified by EPA as of the effective date of these regulations shall be deemed certified only:

1.4.3.1 Through the expiration date of that EPA certification; and

1.4.3.2 Upon the Secretary’s receipt of documentation of that EPA certification.

1.4.4 Work practices. On or after the effective date of these regulations, all renovations in target housing or child-occupied facilities must be performed in accordance with the work practice standards in Section 4.0 and the associated recordkeeping requirements in subsections 5.2.1 through 5.2.6, unless the renovation qualifies for the exception identified in subsection 1.5.1.

1.4.5 Suspension and revocation. On or after the effective date of these regulations, the suspension and revocation provisions in Section 9.0 are effective.

1.4.6 Pre-Renovation information distribution requirements. On or after the effective date of these regulations, firms performing renovations must provide owners and occupants with the EPA pamphlet: “Renovate Right: Important Lead Hazard Information for Families, Child Care Providers and Schools,” or any State of Delaware pamphlet approved by EPA pursuant to 40 CFR §745.326 that is developed for the same purpose.

1.4.7 A written Occupant Protection Plan, or electronic equivalent, shall be developed for all Renovation, Repair, and Painting projects and shall be prepared according to the following procedures:

1.4.7.1 The Occupant Protection Plan shall be unique to each residential dwelling or child-occupied facility and be developed prior to the Renovation, Repair, and Painting project. The occupant protection plan shall describe the measures and management procedures that will be taken during the Renovation, Repair, and Painting project to protect the building occupants from exposure to any lead-based paint hazards.

1.4.7.2 A certified renovator shall prepare the Occupant Protection Plan.

1.5 Applicability.

1.5.1 These regulations apply to all renovations performed for compensation in target housing and child-occupied facilities, except for the following:

1.5.1.1 Renovations in target housing or child-occupied facilities for which:

1.5.1.1.1 A written determination has been made by an inspector or risk assessor, certified pursuant to 16 DE Admin. Code 4459, that the components affected by the renovation are free of paint or other surface coatings that contain lead equal to or in excess of 1.0 milligrams/per square centimeter (mg/cm2) or 0.5% by weight; and

1.5.1.1.2 The firm performing the renovation has obtained a copy of the determination.

1.5.1.2 Renovations in target housing or child-occupied facilities for which:

1.5.1.2.1 A certified Renovator, using an EPA-recognized test kit as defined in 40 CFR §745.83 and following the kit manufacturer's instructions, has tested each component affected by the renovation; and

1.5.1.2.2 The certified Renovator determined that the components are free of paint or other surface coatings that contain lead equal to or in excess of 1.0 mg/cm2 or 0.5% by weight. If the components make up an integrated whole, such as the individual stair treads and risers of a single staircase, the Renovator is required to test only 1 of the individual components, unless the individual components appear to have been repainted or refinished separately.

1.5.1.3 Renovations in target housing or child-occupied facilities for which:

1.5.1.3.1 A certified Renovator has collected a paint chip sample from each painted component affected by the renovation;

1.5.1.3.2 The Renovator is required to test only 1 of the individual components if the components make up an integrated whole, such as the individual stair treads and risers of a single staircase, unless the individual components appear to have been repainted or refinished separately; and

1.5.1.3.3 A laboratory recognized by EPA pursuant to section 405(b) of the Toxic Substances Control Act of 1976, as amended, (15 USC §2601 et.seq.) as being capable of performing analyses for lead compounds in paint chip samples has determined that the samples are free of paint or other surface coatings that contain lead equal to or in excess of 1.0 mg/cm2 or 0.5% by weight.

1.5.2 Emergency renovations.

1.5.2.1 The information distribution requirements in Section 3.0 do not apply to emergency renovations, which are renovation activities that were not planned but result from a sudden, unexpected event (such as non-routine failures of equipment) that, if not immediately attended to, presents a safety or public health hazard, or threatens equipment or property with significant damage. Interim controls performed in response to an elevated blood lead level in a resident child are also emergency renovations.

1.5.2.2 To the extent necessary to respond to the emergency, the warning sign, containment, waste handling, training, and certification requirements in Sections 4.0, 7.0, and 8.0 do not apply to emergency renovations, other than interim controls.

1.5.2.3 Emergency renovations are not exempt from:

1.5.2.3.1 The cleaning requirements in subsection 4.1.5, which must be performed by certified Renovators or individuals trained in accordance with subsection 8.2.2;

1.5.2.3.2 The cleaning verification requirements in subsection 4.2, which must be performed by certified Renovators; and

1.5.2.3.3 The recordkeeping requirements in subsection 5.2.6.

**History**
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *17 DE Reg. 735 (01/01/14)*
- *26 DE Reg. 699 (02/01/23)*

##### **16 Del. Admin. Code § 4459B-2.0** Definitions {#sec-4459b-2.0 omnilex-key=us-de-regs-official--title-16--4459B-2.0}

2.1 For purposes of these regulations, the definitions in 16 DE Admin. Code 4459, as well as the following definitions apply. The following words and terms when used in this regulation shall have the following meaning unless the context clearly indicates otherwise:

“Certified renovator” means an individual who has been certified by the Secretary to perform renovations and direct workers who perform renovations.

“Child-occupied facility” means a building, or portion of a building, constructed prior to 1978, visited regularly by the same child, under six years of age, on at least two different days within any week (Sunday through Saturday period), provided that each day's visit lasts at least three hours and the combined weekly visits last at least six hours, and the combined annual visits last at least 60 hours. Child-occupied facilities may include, but are not limited to daycares, preschools, and kindergarten classrooms. Child-occupied facilities may be located in target housing or in public or commercial buildings. With respect to common areas in public or commercial buildings that contain child-occupied facilities, the child-occupied facility encompasses only those common areas that are routinely used by children under age six, such as restrooms and cafeterias. Common areas that children under age six only pass through, such as hallways, stairways, and garages are not included. In addition, with respect to exteriors of public or commercial buildings that contain child-occupied facilities, the child-occupied facility encompasses only the exterior sides of the building that are immediately adjacent to the child-occupied facility or the common areas routinely used by children under age six.

“Cleaning verification card” means a card developed and distributed, or otherwise approved, by EPA for the purpose of determining, through comparison of wet and dry disposable cleaning cloths with the card, whether post-renovation cleaning has been properly completed.

"Component or "Building component" means specific design or structural elements or fixtures of a building, residential dwelling, or child-occupied facility that are distinguished from each other by form, function, and location. These include, but are not limited to, interior components such as: ceilings, crown moldings, walls, chair rails, doors, door trim, floors, fireplaces, radiators, and other heating units, shelves, shelf supports, stair treads, stair risers, stair stringers, newel posts, railing caps, balustrades, windows and trim (including sashes, windows heads, jambs, sills or stools and troughs), built in cabinets, columns, beams, bathroom vanities, counter tops and air conditioners; and exterior components such as: painted roofing, chimneys, flashing, gutters and down spouts, ceilings, soffits, fascias, rake boards, corner boards, bulkheads, doors and door trim, fences, floors, joists, lattice work, railings and railing caps, siding handrails, stair risers and treads, stair stringers, columns, balustrades, windowsills or stools and troughs, casings, sashes, wells, and air conditioners.

“Dry disposable cleaning cloth” means a commercially available dry, electrostatically charged, white disposable cloth designed to be used for cleaning hard surfaces such as uncarpeted floors or counter tops.

"EPA" means U.S. Environmental Protection Agency.

“Firm” means a company, partnership, corporation, sole proprietorship or individual doing business, association, or other business entity; a Federal, State, Tribal, or local government agency; or a nonprofit organization.

“HEPA vacuum” means a vacuum cleaner which has been designed with a high-efficiency particulate air (HEPA) filter as the last filtration stage. A HEPA filter is a filter that is capable of capturing particulates of 0.3 microns with 99.97% efficiency. The vacuum cleaner must be designed so that all the air drawn into the machine is expelled through the HEPA filter with none of the air leaking past it. HEPA vacuums must be operated and maintained in accordance with the manufacturer's instructions.

“Interim controls” means a set of measures designed to temporarily reduce human exposure or likely exposure to lead-based paint hazards, including specialized cleaning, repairs, maintenance, painting, temporary containment, ongoing monitoring of lead-based paint hazards or potential hazards, and the establishment and operation of management and resident education programs.

"Lead-based paint activities" means, in the case of target housing and child-occupied facilities, inspection, risk assessment, abatement, renovation, and dust sampling as provided in these regulations and in 16 DE Admin. Code 4459.

“Minor repair and maintenance activities” means activities including minor heating, ventilation or air conditioning work, electrical work, and plumbing, that disrupt six square feet or less of painted surface per room for interior activities or 20 square feet or less of painted surface for exterior activities where none of the work practices prohibited or restricted by subsection 4.1.3 are used and where the work does not involve window replacement or demolition of painted surface areas. When removing painted components, or portions of painted components, the entire surface area removed is the amount of painted surface disturbed. Jobs, other than emergency renovations, performed in the same room within the same 30 days must be considered the same job for the purpose of determining whether the job is a minor repair and maintenance activity.

"Occupant Protection Plan" means a plan developed by a certified renovator prior to the commencement of lead renovation, repair, and painting work in a residential dwelling or child-occupied facility that describes the measures and management procedures that will be taken during lead renovation, repair, and painting work to protect the building occupants from exposure to any lead- based paint hazards.

“Painted surface” means a component surface covered in whole or in part with paint or other surface coatings.

“Pamphlet” means the EPA pamphlet titled “Renovate Right: Important Lead Hazard Information for Families, Child Care Providers and Schools” developed under section 406(a) of the Toxic Substances Control Act of 1976, as amended, (15 USC §2601 et.seq.) (TSCA) for use in complying with section 406(b) of TSCA, or any State of Delaware pamphlet approved by EPA pursuant to 40 CFR §745.326 that is developed for the same purpose. This includes reproductions of the pamphlet when copied in full and without revision or deletion of material from the pamphlet (except for the addition or revision of State or local sources of information).

"Person" means any natural or judicial person including any individual, corporation, partnership, or association; any Indian Tribe, State, or political subdivision thereof; any interstate body; and any department, agency, or instrumentality of the Federal, State, or local government.

“Recognized test kit” means a commercially available kit recognized by EPA under 40 CFR §745.88 as being capable of allowing a user to determine the presence of lead at levels equal to or in excess of 1.0 milligrams per square centimeter, or more than 0.5% lead by weight, in a paint chip, paint powder, or painted surface.

"Secretary" means the Administrator of the Department of Health and Social Services (DHSS) of the State of Delaware or the Secretary’s designee, who shall hereafter in this document be referred to as: Secretary; The Secretary; or, Secretary, DHSS.

"Target housing" means any housing constructed prior to 1978, except housing for the elderly or persons with disabilities (unless any one or more children aged 6 years or under resides or is expected to reside in such housing for the elderly or persons with disabilities) or any 0-bedroom dwelling.

"Training hour" means at least 50 minutes of actual learning, including, but not limited to, time devoted to lecture, learning activities, small group activities, demonstrations, evaluations, and, if applicable, hands-on experience.

“Vertical containment” means a vertical barrier consisting of plastic sheeting or other impermeable material over scaffolding or a rigid frame, or an equivalent system of containing the work area. Vertical containment is required for some exterior renovations, but it may be used on any renovation.

“Wet disposable cleaning cloth” means a commercially available, pre-moistened white disposable cloth designed to be used for cleaning hard surfaces, such as uncarpeted floors or counter tops.

“Wet mopping system” means a device with the following characteristics: a long handle, a mop head designed to be used with disposable absorbent cleaning pads, a reservoir for cleaning solution, and a built-in mechanism for distributing or spraying the cleaning solution onto a floor, or a method of equivalent efficacy.

“Work area” means the area that the certified renovator establishes to contain the dust and debris generated by a renovation.

**History**
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *17 DE Reg. 735 (01/01/14)*
- *26 DE Reg. 699 (02/01/23)*

##### **16 Del. Admin. Code § 4459B-3.0** Information Distribution Requirements {#sec-4459b-3.0 omnilex-key=us-de-regs-official--title-16--4459B-3.0}

3.1 Written or electronic notification of the commencement of lead-based paint renovation activities in target housing or a child-occupied facilities or as a result of a Federal, State of Delaware, or local order shall be given to the Secretary 5 business days prior to the commencement of renovation activities. This requirement will be considered satisfied by compliance with subsection 3.1.1 of this regulation.

3.1.1 The lead renovation firm must submit a Start Work Notification to the Department of Health and Social Services at least 5 business days before beginning work that includes any set of measures designed to temporarily reduce human exposure or likely exposure to lead-based paint hazards, including:

3.1.1.1 Specialized cleaning;

3.1.1.2 Repairs;

3.1.1.3 Maintenance;

3.1.1.4 Painting;

3.1.1.5 Temporary containment;

3.1.1.6 Ongoing monitoring of lead-based paint hazards or potential hazards; and

3.1.1.7 The establishment and operation of management and resident education programs.

3.2 Renovations in dwelling units. No more than 60 days before beginning renovation activities in any residential dwelling unit of target housing, the firm performing the renovation must:

3.2.1 Provide the owner of the unit with the pamphlet and Occupant Protection Plan, and comply with one of the following:

3.2.1.1 Obtain, from the owner, a written acknowledgment that the owner has received the pamphlet and Occupant Protection Plan; or

3.2.1.2 Obtain a certificate of mailing at least seven (7) days prior to the renovation.

3.2.2 In addition to the requirements in subsection 3.2.1, if the owner does not occupy the dwelling unit, provide an adult occupant of the unit with the pamphlet and Occupant Protection Plan, and comply with one of the following:

3.2.2.1 Obtain, from the adult occupant, a written acknowledgment that the occupant has received the pamphlet and Occupant Protection Plan or certify in writing that a pamphlet and Occupant Protection Plan has been delivered to the dwelling and that the firm performing the renovation has been unsuccessful in obtaining a written acknowledgment from an adult occupant. Such certification must include the address of the unit undergoing renovation, the date and method of delivery of the pamphlet and Occupant Protection Plan, names of the persons delivering the pamphlet and Occupant Protection Plan, reason for lack of acknowledgment (e.g., occupant refuses to sign, no adult occupant available), the signature of a representative of the firm performing the renovation, and the date of signature; or

3.2.2.2 Obtain a certificate of mailing at least seven (7) days prior to the renovation.

3.3 Renovations in common areas. No more than 60 days before beginning renovation activities in common areas of multi-unit target housing, the firm performing the renovation must:

3.3.1 Provide the owner with the pamphlet and Occupant Protection Plan, and comply with one of the following:

3.3.1.1 Obtain, from the owner, a written acknowledgment that the owner has received the pamphlet and Occupant Protection Plan; or.

3.3.1.2 Obtain a certificate of mailing at least seven (7) days prior to the renovation.

3.3.2 Comply with one of the following:

3.3.2.1 Notify in writing, or ensure written notification of, each affected unit and make the pamphlet and Occupant Protection Plan available upon request prior to the start of renovation. Such notification shall be accomplished by distributing written notice to each affected unit. The notice shall describe the general nature and locations of the planned renovation activities; the expected starting and ending dates; and a statement of how the occupant can obtain the pamphlet and Occupant Protection Plan, and a copy of the records required by subsections 5.3 and 5.4, at no cost to the occupants.

3.3.2.2 While the renovation is ongoing, post informational signs describing the general nature and locations of the renovation and the anticipated completion date. These signs must be posted in areas where they are likely to be seen by the occupants of all of the affected units. The signs must be accompanied by a posted copy of the pamphlet and Occupant Protection Plan or information on how interested occupants can review a copy of the pamphlet and Occupant Protection Plan or obtain a copy from the renovation firm at no cost to occupants. The signs must also include information on how interested occupants can review a copy of the records required by subsections 5.3 and 5.4 or obtain a copy from the renovation firm at no cost to the occupants.

3.3.3 Prepare, sign, and date a statement describing the steps performed to notify all occupants of the intended renovation activities and to provide the pamphlet and Occupant Protection Plan.

3.3.4 If the scope, locations, or expected starting and ending dates of the planned renovation activities change after the initial notification, and the firm provided written initial notification to each affected unit, the firm performing the renovation must provide further written notification to the owners and occupants providing revised information on the ongoing or planned activities. This subsequent notification must be provided before the firm performing the renovation initiates work beyond that which was described in the original notice.

3.4 Renovations in child-occupied facilities. No more than 60 days before beginning renovation activities in any child-occupied facility, the firm performing the renovation must:

3.4.1 Provide the owner of the building with the pamphlet and Occupant Protection Plan, and comply with one of the following:

3.4.1.1 Obtain, from the owner, a written acknowledgment that the owner has received the pamphlet and Occupant Protection Plan.

3.4.1.2 Obtain a certificate of mailing at least seven (7) days prior to the renovation.

3.4.2 If the child-occupied facility is not the owner of the building, provide an adult representative of the child-occupied facility with the pamphlet and Occupant Protection Plan, and comply with one of the following:

3.4.2.1 Obtain, from the adult representative, a written acknowledgment that the adult representative has received the pamphlet and Occupant Protection Plan; or certify in writing that a pamphlet and Occupant Protection Plan have been delivered to the facility and that the firm performing the renovation has been unsuccessful in obtaining a written acknowledgment from an adult representative. Such certification must include the address of the child-occupied facility undergoing renovation, the date and method of delivery of the pamphlet and Occupant Protection Plan, names of the persons delivering the pamphlet, reason for lack of acknowledgment (e.g., representative refuses to sign), the signature of a representative of the firm performing the renovation, and the date of signature.

3.4.2.2 Obtain a certificate of mailing at least seven (7) days prior to the renovation.

3.4.3 Provide the parents and guardians of children using the child-occupied facility with the pamphlet and Occupant Protection Plan, information describing the general nature and locations of the renovation and the anticipated completion date, and information on how interested parents or guardians of children frequenting the child-occupied facility can review a copy of the records required by subsections 5.3 and 5.4 or obtain a copy from the renovation firm at no cost to the occupants by complying with one of the following:

3.4.3.1 Mail or hand-deliver the pamphlet, Occupant Protection Plan, and the renovation information to each parent or guardian of a child using the child-occupied facility.

3.4.3.2 While the renovation is ongoing, post informational signs describing the general nature and locations of the renovation and the anticipated completion date. These signs must be posted in areas where they can be seen by the parents or guardians of the children frequenting the child-occupied facility. The signs must be accompanied by a posted copy of the pamphlet and Occupant Protection Plan or information on how interested parents or guardians of children frequenting the child-occupied facility can review a copy of the pamphlet and Occupant Protection Plan or obtain a copy from the renovation firm at no cost to the parents or guardians. The signs must also include information on how interested parents or guardians of children frequenting the child-occupied facility can review a copy of the records required by subsections 5.3 and 5.4 or obtain a copy from the renovation firm at no cost to the parents or guardians.

3.4.4 The renovation firm must prepare, sign, and date a statement describing the steps performed to notify all parents and guardians of the intended renovation activities and to provide the pamphlet.

3.5 Written acknowledgment. The written acknowledgments required by subsections 3.2.1.1, 3.2.2.1, 3.3.1.1, 3.4.1.1, and 3.4.2.1 must:

3.5.1 Include a statement recording the owner or occupant's name and acknowledging receipt of the pamphlet prior to the start of renovation, the address of the unit undergoing renovation, the signature of the owner or occupant as applicable, and the date of signature;

3.5.2 Be either a separate sheet or part of any written contract or service agreement for the renovation; and

3.5.3 Be written in the same language as the text of the contract or agreement for the renovation or, in the case of non-owner occupied target housing, in the same language as the lease or rental agreement or the pamphlet and Occupant Protection Plan.

**History**
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *17 DE Reg. 735 (01/01/14)*
- *26 DE Reg. 699 (02/01/23)*

##### **16 Del. Admin. Code § 4459B-4.0** Work Practice Standards {#sec-4459b-4.0 omnilex-key=us-de-regs-official--title-16--4459B-4.0}

4.1 Standards for renovation activities. Renovations must be performed by certified firms using certified renovators as directed in Section 7.0. The responsibilities of certified firms are set forth in subsection 7.4 and the responsibilities of certified renovators are set forth in subsection 8.8.

4.1.1 Occupant protection. Firms must post signs clearly defining the work area and warning occupants and other persons not involved in renovation activities to remain outside of the work area. To the extent practicable, these signs must be in the primary language of the occupants. These signs must be posted before beginning the renovation and must remain in place and readable until the renovation and the post-renovation cleaning verification have been completed. If warning signs have been posted in accordance with 24 CFR 35.1345(b)(2) or 29 CFR 1926.62(m), additional signs are not required by this section.

4.1.2 Containing the work area. Before beginning the renovation, the firm must isolate the work area so that no dust or debris leaves the work area while the renovation is being performed. In addition, the firm must maintain the integrity of the containment by ensuring that any plastic or other impermeable materials are not torn or displaced, and taking any other steps necessary to ensure that no dust or debris leaves the work area while the renovation is being performed. The firm must also ensure that containment is installed in such a manner that it does not interfere with occupant and worker egress in an emergency.

4.1.2.1 Interior renovations. The firm must:

4.1.2.1.1 Remove all objects from the work area, including furniture, rugs, and window coverings, or cover them with plastic sheeting or other impermeable material with all seams and edges taped or otherwise sealed.

4.1.2.1.2 Close and cover all ducts opening in the work area with taped-down plastic sheeting or other impermeable material.

4.1.2.1.3 Close windows and doors in the work area. Doors must be covered with plastic sheeting or other impermeable material. Doors used as an entrance to the work area must be covered with plastic sheeting or other impermeable material in a manner that allows workers to pass through while confining dust and debris to the work area.

4.1.2.1.4 Cover the floor surface, including installed carpet, with taped-down plastic sheeting or other impermeable material in the work area six (6) feet beyond the perimeter of surfaces undergoing renovation or a sufficient distance to contain the dust, whichever is greater. Floor containment measures may stop at the edge of the vertical barrier when using a vertical containment system consisting of impermeable barriers that extend from the floor to the ceiling and are tightly sealed at joints with the floor, ceiling and walls.

4.1.2.1.5 Use precautions to ensure that all personnel, tools, and other items, including the exteriors of containers of waste, are free of dust and debris before leaving the work area.

4.1.2.2 Exterior renovations. The firm must:

4.1.2.2.1 Close all doors and windows within 20 feet of the renovation. On multi-story buildings, close all doors and windows within 20 feet of the renovation on the same floor as the renovation, and close all doors and windows on all floors below that are the same horizontal distance from the renovation.

4.1.2.2.2 Ensure that doors within the work area that will be used while the job is being performed are covered with plastic sheeting or other impermeable material in a manner that allows workers to pass through while confining dust and debris to the work area.

4.1.2.2.3 Cover the ground with plastic sheeting or other disposable impermeable material extending 10 feet beyond the perimeter of surfaces undergoing renovation or a sufficient distance to collect falling paint debris, whichever is greater, unless the property line prevents 10 feet of such ground covering. Ground containment measures may stop at the edge of the vertical barrier when using a vertical containment system.

4.1.2.2.4 If the renovation will affect surfaces within 10 feet of the property line, the renovation firm must erect vertical containment or equivalent extra precautions in containing the work area to ensure that dust and debris from the renovation do not contaminate adjacent buildings or migrate to adjacent properties. Vertical containment or equivalent extra precautions in containing the work area may also be necessary in other situations in order to prevent contamination of other buildings, other areas of the property, or adjacent buildings or properties.

4.1.3 Prohibited and restricted practices. The work practices listed below are prohibited or restricted during a renovation as follows:

4.1.3.1 Open flame burning or torching of painted surfaces is prohibited.

4.1.3.2 The use of machines designed to remove paint or other surface coatings through high-speed operation such as sanding, grinding, power planing, needle gun, abrasive blasting, or sandblasting, is prohibited on painted surfaces unless such machines have shrouds or containment systems and are equipped with a HEPA vacuum attachment to collect dust and debris at the point of generation. Machines must be operated so that no visible dust or release of air occurs outside the shroud or containment system.

4.1.3.3 Operating a heat gun on painted surfaces is permitted only at temperatures below 1,100 degrees Fahrenheit.

4.1.4 Waste from renovations.

4.1.4.1 Waste from renovation activities must be contained to prevent releases of dust and debris before the waste is removed from the work area for storage or disposal. If a chute is used to remove waste from the work area, it must be covered.

4.1.4.2 At the conclusion of each workday and at the conclusion of the renovation, waste that has been collected from renovation activities must be stored under containment, in an enclosure, or behind a barrier that prevents release of dust and debris out of the work area and prevents access to dust and debris.

4.1.4.3 When the firm transports waste from renovation activities, the firm must contain the waste to prevent release of dust and debris.

4.1.5 Cleaning the work area. After the renovation has been completed, the firm must clean the work area until no dust, debris or residue remains.

4.1.5.1 Interior and exterior renovations. The firm must:

4.1.5.1.1 Collect all paint chips and debris and, without dispersing any of it, seal this material in a heavy-duty bag.

4.1.5.1.2 Remove the protective sheeting. Mist the sheeting before folding it, fold the dirty side inward, and either tape shut to seal or seal in heavy-duty bags. Sheeting used to isolate contaminated rooms from non-contaminated rooms must remain in place until after the cleaning and removal of other sheeting. Dispose of the sheeting as waste.

4.1.5.2 Additional cleaning for interior renovations. The firm must clean all objects and surfaces in the work area and within two (2) feet of the work area in the following manner, cleaning from higher to lower:

4.1.5.2.1 Clean walls starting at the ceiling and working down to the floor by either vacuuming with a HEPA vacuum or wiping with a damp cloth.

4.1.5.2.2 Thoroughly vacuum all remaining surfaces and objects in the work area, including furniture and fixtures, with a HEPA vacuum. The HEPA vacuum must be equipped with a beater bar when vacuuming carpets and rugs.

4.1.5.2.3 Wipe all remaining surfaces and objects in the work area, except for carpeted or upholstered surfaces, with a damp cloth. Mop uncarpeted floors thoroughly, using a mopping method that keeps the wash water separate from the rinse water, such as the 2-bucket mopping method, or using a wet mopping system.

4.2 Standards for post-renovation cleaning verification.

4.2.1 Interiors.

4.2.1.1 A certified renovator must perform a visual inspection to determine whether dust, debris, or residue is still present. If dust, debris, or residue is present, these conditions must be removed by re-cleaning and another visual inspection must be performed.

4.2.1.2 After a successful visual inspection, a certified renovator must:

4.2.1.2.1 Verify that each windowsill in the work area has been adequately cleaned, using the following procedure.

4.2.1.2.1.1 Wipe the windowsill with a wet disposable cleaning cloth that is damp to the touch. If the cloth matches or is lighter than the cleaning verification card, the windowsill has been adequately cleaned.

4.2.1.2.1.2 If the cloth does not match and is darker than the cleaning verification card, re-clean the windowsill as directed in subsections 4.1.5.2.2 and 4.1.5.2.3, then either use a new cloth or fold the used cloth in such a way that an unused surface is exposed, and wipe the surface again. If the cloth matches or is lighter than the cleaning verification card, that windowsill has been adequately cleaned.

4.2.1.2.1.3 If the cloth does not match and is darker than the cleaning verification card, wait for one (1) hour or until the surface has dried completely, whichever is longer. After waiting for the windowsill to dry, wipe the windowsill with a dry disposable cleaning cloth. After this wipe, the windowsill has been adequately cleaned.

4.2.1.2.2 Wipe uncarpeted floors and countertops within the work area with a wet disposable cleaning cloth. Floors must be wiped using an application device with a long handle and a head to which the cloth is attached. The cloth must remain damp at all times while it is being used to wipe the surface for post-renovation cleaning verification. If the surface within the work area is greater than 40 square feet, the surface within the work area must be divided into roughly equal sections that are each less than 40 square feet. Wipe each such section separately with a new wet disposable cleaning cloth. If the cloth used to wipe each section of the surface within the work area matches the cleaning verification card, the surface has been adequately cleaned.

4.2.1.2.2.1 If the cloth used to wipe a particular surface section does not match the cleaning verification card, re-clean that section of the surface as directed in subsections 4.1.5.2.2 and 4.1.5.2.3, then use a new wet disposable cleaning cloth to wipe that section again. If the cloth matches the cleaning verification card, that section of the surface has been adequately cleaned.

4.2.1.2.2.2 If the cloth used to wipe a particular surface section does not match the cleaning verification card after the surface has been re-cleaned, wait for one (1) hour or until the entire surface within the work area has dried completely, whichever is longer. After waiting for the entire surface within the work area to dry, wipe each section of the surface that has not yet achieved post-renovation cleaning verification with a dry disposable cleaning cloth. After this wipe, that section of the surface has been adequately cleaned.

4.2.1.3 When the work area passes the post-renovation cleaning verification, remove the warning signs.

4.2.2 Exteriors. A certified renovator must perform a visual inspection to determine whether dust, debris or residue is still present on surfaces in and below the work area, including windowsills and the ground. If dust, debris or residue is present, these conditions must be eliminated and another visual inspection must be performed. When the area passes the visual inspection, remove the warning signs.

4.3 Optional dust clearance testing. Cleaning verification need not be performed if the contract between the renovation firm and the person contracting for the renovation or a Federal or Tribal law or regulation requires:

4.3.1 The renovation firm to perform dust clearance sampling at the conclusion of a renovation covered by these regulations.

4.3.2 The dust clearance samples be collected by a certified Inspector, Risk Assessor or Dust Wipe Technician.

4.3.3 The renovation firm to re-clean the work area until the dust clearance sample results are below the clearance standards in 16 DE Admin. Code 4459, subsection 5.1.

4.4 Activities conducted after post-renovation cleaning verification. Activities that do not disturb paint, such as applying paint to walls that have already been prepared, are not regulated by these regulations if they are conducted after post-renovation cleaning verification has been performed.

**History**
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *17 DE Reg. 735 (01/01/14)*
- *26 DE Reg. 699 (02/01/23)*

##### **16 Del. Admin. Code § 4459B-5.0** Recordkeeping and Reporting Requirements {#sec-4459b-5.0 omnilex-key=us-de-regs-official--title-16--4459B-5.0}

5.1 Firms performing renovations must retain and, if requested, make available to the Secretary or the Secretary’s designee all records necessary to demonstrate compliance with these regulations for a period of three (3) years following completion of the renovation. This three–year retention requirement does not supersede longer obligations required by other provisions for retaining the same documentation, including any applicable Federal, State, or Tribal laws or regulations.

5.2 Records that must be retained pursuant to subsection 5.1 shall include, where applicable:

5.2.1 Records or reports certifying that a determination had been made that lead-based paint was not present on the components affected by the renovation, as described in subsection 1.5.1. These records or reports include:

5.2.1.1 Reports prepared by a certified Inspector or certified Risk Assessor as defined in 16 DE Admin. Code 4459.

5.2.1.2 Records prepared by a certified renovator after using EPA-recognized test kits, including an identification of the manufacturer and model of any test kits used, a description of the components that were tested including their locations, and the result of each test kit used.

5.2.1.3 Records prepared by a certified renovator after collecting paint chip samples, including a description of the components that were tested and their locations, the name and address of the NLLAP-recognized entity performing the analysis, and the results for each sample.

5.2.2 Signed and dated acknowledgments of receipt as described in subsections 3.2.1.1, 3.2.2.1, 3.3.1.1, 3.4.1.1, and 3.4.2.1.

5.2.3 Certifications of attempted delivery as described in subsections 3.2.2.1 and 3.4.2.1.

5.2.4 Certificates of mailing as described in subsections 3.2.1.1, 3.3.1.2, 3.4.1.2, and 3.4.2.2.

5.2.5 Records of notification activities performed regarding common area renovations, as described in subsections 3.3.3 and 3.3.4 and renovations in child-occupied facilities, as described in subsection 3.4.3.

5.2.6 Documentation of compliance with the requirements of Section 4.0, including documentation that a certified renovator was assigned to the project, that the certified renovator provided on-the-job training for workers used on the project, that the certified renovator performed or directed workers who performed all of the tasks described in subsection 4.1, and that the certified renovator performed the post-renovation cleaning verification described in subsection 4.2. If the renovation firm was unable to comply with all of the requirements of this rule due to an emergency as defined in subsection 1.5, the firm must document the nature of the emergency and the provisions of the rule that were not followed. This documentation must include a copy of the certified renovator's training certificate, and a certification by the certified renovator assigned to the project that:

5.2.6.1 Training was provided to workers (topics must be identified for each worker).

5.2.6.2 Warning signs were posted at the entrances to the work area.

5.2.6.3 If test kits were used, the specified brand of kits was used at the specified locations and that the results were as specified.

5.2.6.4 If paint chip samples were collected, the samples were collected at the specified locations, the specified NLLAP-recognized laboratory analyzed the samples, and the results were as specified.

5.2.6.5 The work area was contained by:

5.2.6.5.1 Removing or covering all objects in the work area (interiors).

5.2.6.5.2 Closing and covering all HVAC ducts in the work area (interiors).

5.2.6.5.3 Closing all windows in the work area (interiors) or closing all windows in and within 20 feet of the work area (exteriors).

5.2.6.5.4 Closing and sealing all doors in the work area (interiors) or closing and sealing all doors in and within 20 feet of the work area (exteriors).

5.2.6.5.5 Covering doors in the work area that were being used to allow passage but prevent spread of dust.

5.2.6.5.6 Covering the floor surface, including installed carpet, with taped-down plastic sheeting or other impermeable material in the work area six (6) feet beyond the perimeter of surfaces undergoing renovation or a sufficient distance to contain the dust, whichever is greater (interiors); or covering the ground with plastic sheeting or other disposable impermeable material anchored to the building extending 10 feet beyond the perimeter of surfaces undergoing renovation or a sufficient distance to collect falling paint debris, whichever is greater, unless the property line prevents 10 feet of such ground covering, weighted down by heavy objects (exteriors).

5.2.6.5.7 Installing (if necessary) vertical containment to prevent migration of dust and debris to adjacent property (exteriors).

5.2.6.6 Waste was contained on-site and while being transported off-site.

5.2.6.7 The work area was properly cleaned after the renovation by:

5.2.6.7.1 Picking up all chips and debris, misting protective sheeting, folding it dirty side inward, and taping it for removal.

5.2.6.7.2 Cleaning the work area surfaces and objects using a HEPA vacuum or wet cloths or mops (interiors).

5.2.6.8 The certified renovator performed the post-renovation cleaning verification (the results of which must be briefly described, including the number of wet and dry cloths used).

5.3 Compliance Information.

5.3.1 When the final invoice for the renovation is delivered or within 30 days of the completion of the renovation, whichever is earlier, the renovation firm must provide information pertaining to compliance with these regulations to the following persons:

5.3.1.1 The owner of the building; and, if different,

5.3.1.2 An adult occupant of the residential dwelling, if the renovation took place within a residential dwelling, or an adult representative of the child-occupied facility, if the renovation took place within a child-occupied facility.

5.3.2 When performing renovations in common areas of multi-unit target housing, renovation firms must post the information required by these regulations or instructions on how interested occupants can obtain a copy of this information. This information must be posted in areas where it is likely to be seen by the occupants of all of the affected units.

5.3.3 The information required to be provided by subsection 5.3 may be provided by completing the sample form titled “Sample Renovation Recordkeeping Checklist” or a similar form containing the test kit information required by subsection 5.2.1.2 and the training and work practice compliance information required by subsection 5.2.6.

5.4 Dust clearance sampling.

5.4.1 If dust clearance sampling is performed in lieu of cleaning verification as permitted by subsection 4.3 the renovation firm must provide, when the final invoice for the renovation is delivered or within 30 days of the completion of the renovation, whichever is earlier, a copy of the dust sampling report to:

5.4.1.1 The owner of the building; and, if different,

5.4.1.2 An adult occupant of the residential dwelling, if the renovation took place within a residential dwelling, or an adult representative of the child-occupied facility, if the renovation took place within a child-occupied facility.

5.4.2 When performing renovations in common areas of multi-unit target housing, renovation firms must post these dust sampling reports or information on how interested occupants of the housing being renovated can obtain a copy of the report. This information must be posted in areas where they are likely to be seen by the occupants of all of the affected units.

**History**
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *17 DE Reg. 735 (01/01/14)*
- *26 DE Reg. 699 (02/01/23)*

##### **16 Del. Admin. Code § 4459B-6.0** Enforcement and Inspections {#sec-4459b-6.0 omnilex-key=us-de-regs-official--title-16--4459B-6.0}

6.1 Failure or refusal to comply with any provision of these regulations is a prohibited act.

6.2 Failure or refusal to establish and maintain records or to make available or permit access to or copying of records, as required by these regulations is a prohibited act.

6.3 Failure or refusal to permit entry or inspection as required by these regulations is a prohibited act.

6.4 Any individual or firm that performs any of the following acts shall be deemed to have committed a prohibited act. These include the following:

6.4.1 Obtaining certification through fraudulent representation.

6.4.2 Failing to obtain certification from the Secretary and performing work at a job site.

6.4.3 Fraudulently obtaining certification and engaging in any lead based paint activity requiring certification.

6.5 Violators may be subject to civil and criminal sanctions pursuant to 16 Del.C. §107 for each violation of the requirements established in these regulations.

6.6 Lead-based paint is assumed to be present at renovations covered by these regulations.

**History**
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *17 DE Reg. 735 (01/01/14)*
- *26 DE Reg. 699 (02/01/23)*

##### **16 Del. Admin. Code § 4459B-7.0** Firm Certification {#sec-4459b-7.0 omnilex-key=us-de-regs-official--title-16--4459B-7.0}

7.1 Initial certification.

7.1.1 Firms that perform renovations for compensation must apply to the Secretary for certification to perform renovations or dust sampling. To apply, a firm must:

7.1.1.1 Use an application form approved by the Secretary.

7.1.1.2 Submit a completed application signed by an authorized agent of the firm attesting that:

7.1.1.2.1 The firm and its employees shall permit the Secretary access to enter premises or facilities where the firm conducts business, including work sites, to execute reasonable inspection, including taking samples, to ensure compliance with regulations;

7.1.1.2.2 The firm and its employees shall follow the work practices in Section 4.0; and

7.1.1.2.3 The firm shall only employ appropriately certified renovators and Dust Wipe Technicians to conduct renovations for compensation in target housing and child-occupied facilities.

7.1.1.3 Submit the correct certification fee amount with the completed application.

7.1.2 After receipt of a firm's application, the Secretary will take one of the following actions within 90 days of the date the application is received:

7.1.2.1 Approve the firm's application if it is complete and that the environmental compliance history of the firm, its principals, or its key employees does not show an unwillingness or inability to maintain compliance with environmental statutes or regulations. A signed application is complete if it contains all of the information requested on the form, including the signed attestation, and the correct fee amount is received by the Secretary. Upon approval, the Secretary issues the firm a certificate with an expiration date not more than 5 years from the date the application is approved.

7.1.2.2 Not approve the firm's application if the firm did not provide a complete application and the correct certification fee amount, or if the Secretary determines that the environmental compliance history of the firm, its principals, or its key employees demonstrates an unwillingness or inability to maintain compliance with environmental statutes or regulations. The Secretary will send the firm a letter giving the reason for not approving the application and will return the submitted fee. A firm may reapply for certification at any time by filing a new, complete application that includes the correct fee amount.

7.2 Re-certification.

7.2.1 To maintain its certification, a firm must be re-certified by the Secretary every 5 years and must submit a timely and complete application. To be re-certified, a firm must:

7.2.1.1 Use an application form approved by the Secretary.

7.2.1.2 Submit a completed application signed by an authorized agent of the firm attesting that:

7.2.1.2.1 The firm and its employees shall permit the Secretary access to enter premises or facilities where the firm conducts business, including work sites, to execute reasonable inspection, including taking samples, to ensure compliance with regulations;

7.2.1.2.2 The firm and its employees shall follow the work practices in Section 4.0; and

7.2.1.2.3 The firm shall only employ appropriately certified renovators and Dust Wipe Technicians to conduct renovations for compensation in target housing and child-occupied facilities.

7.2.1.3 Submit the correct certification fee amount with the completed application.

7.2.1.4 An application for re-certification is timely if it is postmarked 90 days or more before the date the firm's current certification expires.

7.2.1.4.1 If the firm's application is complete and timely, the firm's current certification will remain in effect until its expiration date or until the Secretary has made a final decision to approve or disapprove the re-certification application, whichever is later.

7.2.1.4.2 If the firm submits a complete re-certification application less than 90 days before its current certification expires, and the Secretary does not approve the application before the expiration date, the firm's current certification will expire and the firm will not be able to conduct renovations until the Secretary approves its re-certification application.

7.2.1.5 If an application for re-certification is not submitted prior to the expiration of the firm's current certification expires, the firm must not perform renovations or dust sampling until it is certified anew pursuant to subsection 7.1.

7.2.2 After receipt of a firm's application for re-certification, the Secretary will review the application and take one of the following actions within 90 days of receipt:

7.2.2.1 Approve the firm's application if the Secretary determines that it is timely and complete and that the environmental compliance history of the firm, its principals, or its key employees does not show an unwillingness or inability to maintain compliance with environmental statutes or regulations. The Secretary will issue the firm a new certificate with an expiration date 5 years from the date that the firm's current certification expires.

7.2.2.2 Not approve a firm's re-certification application if it is not received or is not complete and the correct certification fee amount was not submitted as of the date that the firm's current certification expires, or if the Secretary determines that the environmental compliance history of the firm, its principals, or its key employees demonstrates an unwillingness or inability to maintain compliance with environmental statutes or regulations. The Secretary will send the firm a letter and will return the fee. A firm may reapply for certification at any time by filing a new application and paying the correct amount of fees.

7.3 Amendment of certification. A firm must amend its certification within 90 days of the date a change occurs to information included in the firm's most recent application. If the firm fails to amend its certification within 90 days of the date the change occurs, the firm may not perform renovations or dust sampling until its certification is amended.

7.3.1 To amend a certification, a firm must submit a complete application for re-certification. A complete application for re-certification:

7.3.1.1 Uses the form approved by the Secretary for re-certification, contains all of the information requested on the form and clearly indicates which items have changed;

7.3.1.2 Is signed by an authorized agent of the firm attesting that:

7.3.1.2.1 The firm and its employees shall permit the Secretary access to enter premises or facilities where the firm conducts business, including work sites, to execute reasonable inspection, including taking samples, to ensure compliance with regulations;

7.3.1.2.2 The firm and its employees shall follow the work practices in Section 4.0.; and

7.3.1.2.3 The firm shall only employ appropriately certified renovators and Dust Wipe Technicians to conduct renovations for compensation in target housing and child-occupied facilities.

7.3.2 If additional information is needed to process the amendment, the Secretary will return the amendment to the firm with a letter giving the reason for not approving the amendment. The firm's certification is not amended until the firm complies with subsection 7.3.1.

7.3.3 Amending a certification does not affect the certification expiration date.

7.4 Firm responsibilities. Responsibilities of firms performing renovations include, but are not limited to ensuring that:

7.4.1 All individuals performing renovation activities on behalf of the firm are either certified renovators or have been trained by a certified renovator in accordance with Section 8.0.

7.4.2 A certified renovator is assigned to each renovation performed by the firm and discharges all of the certified renovator responsibilities identified in Section 8.0.

7.4.3 All renovations performed by the firm are performed in accordance with the work practice standards in Section 4.0.

7.4.4 The pre-renovation education requirements of Section 3.0 have been performed.

7.4.5 The recordkeeping requirements of Section 5.0 are met.

**History**
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *17 DE Reg. 735 (01/01/14)*
- *26 DE Reg. 699 (02/01/23)*

##### **16 Del. Admin. Code § 4459B-8.0** Renovator Certification and Dust Wipe Technician Certification and Responsibilities {#sec-4459b-8.0 omnilex-key=us-de-regs-official--title-16--4459B-8.0}

8.1 Renovator certification and Dust Wipe Technician certification. Except as provided in subsection 8.2, individuals seeking Renovator and Dust Wipe Technician certification must either:

8.1.1 Submit to the Secretary, a complete application on a form approved by the Secretary demonstrating that they meet the requirements established in 8.3 for the particular discipline for which certification is sought and the required certification fee; or

8.1.2 Submit to the Secretary, an application that includes:

8.1.2.1 A copy of a valid lead-based paint activities Renovator or Dust Wipe Technician certification (or equivalent) from a State or Tribal program that has been authorized by the EPA;

8.1.2.2 A passport or digital photo of the applicant; and

8.1.2.3 The required certification fee.

8.2 A Renovator or Dust Wipe Technician accredited by EPA as of the effective date of these regulations shall be deemed accredited only:

8.2.1 Through the expiration date of that EPA certification; and

8.2.2 Upon the Secretary’s receipt of documentation of that EPA certification.

8.3 In addition to the requirements in subsection 8.1, to become a certified renovator or certified Dust Wipe Technician, an individual must successfully complete the appropriate course accredited by the Secretary, EPA, or a State or Tribal program authorized by EPA.

8.4 Following the submission of a complete application demonstrating that all the requirements of this section have been met and the required certification fee, the Secretary shall certify an applicant as a Renovator or Dust Wipe Technician, as appropriate for a period of 5 years.

8.5 Upon receiving certification from the Secretary, all Renovators and Dust Wipe Technicians must comply with the work practice standards established in Section 4.0 of these regulations.

8.6 On or after the effective date of these regulations, it shall be a violation of the work practice standards for an individual to conduct any renovation activities described in Section 4.0, if that individual has not been certified by the Secretary.

8.7 To maintain Renovator certification or Dust Wipe Technician certification, an individual must complete a Renovator or Dust Wipe Technician Refresher course accredited by the Secretary, EPA, or a State or Tribal program authorized by EPA:

8.7.1 Within 5 years of the date the individual successfully completed the initial or refresher course, as applicable, except as provided in subsections 8.7.2 and 8.7.3.

8.7.2 Prior to the expiration of the individual’s EPA certification, if the individual was certified by EPA as of the effective date of these regulations.

8.7.3 An individual may apply to be recertified by the Secretary during the six-month period following certification expiration only if the individual has not performed any renovation activities authorized by that certification after the date that the certification expired.

8.7.4 If an individual does not complete a refresher course within the timeframes required, as appropriate by these regulations, the individual must re-take the initial course to become certified again.

8.7.5 Individuals who take a renovator refresher course that does not include hands-on training will be certified for 3 years from the date they complete the training. Individuals who take a refresher training course that includes hands-on training will be certified for 5 years. Individuals who take the renovator refresher without hands-on training must, for their next refresher course, take a refresher course that includes hands-on training to maintain renovator certification.

8.8 Renovator responsibilities. Certified renovators are responsible for ensuring compliance with Section 4.0 at all renovations to which they are assigned. A certified renovator:

8.8.1 Must perform all of the tasks described in subsection 4.2 and must either perform, or direct workers who perform, all of the tasks described in subsection 4.1.

8.8.2 Must provide training to workers on the work practices required by subsection 4.1 that they will be using in performing their assigned tasks.

8.8.3 Must be physically present at the work site when the signs required by subsection 4.1.1 are posted, while the work area containment required by subsection 4.1.2 is being established, and while the work area cleaning required by subsection 4.1.5 is performed.

8.8.4 Must regularly direct work being performed by other individuals to ensure that the work practices required by subsection 4.1 are being followed, including maintaining the integrity of the containment barriers and ensuring that dust or debris does not spread beyond the work area.

8.8.5 Must be available, either on-site or by telephone, at all times that renovations are being conducted.

8.8.6 When requested by the party contracting for renovation services, must use an acceptable test kit or take paint chip samples to determine whether components to be affected by the renovation contain lead-based paint.

8.8.7 Must have with them at the work site:

8.8.7.1 Their certification from the Secretary; or

8.8.7.2 Only if they meet the certification requirement of subsection 8.2, copies of their initial course completion certificate and their most recent refresher course completion certificate.

8.8.8 Must prepare the records required by subsections 5.2.1.2 and 5.2.6.

8.9 Dust Wipe Technician responsibilities. When performing optional dust clearance sampling under subsection 3.3, a certified Dust Wipe Technician:

8.9.1 Must collect dust samples in accordance with 16 DE Admin. Code 4459, subsection 5.5.8, must send the collected samples to a laboratory recognized by EPA under TSCA section 405(b), and must compare the results to the clearance levels in accordance with 16 DE Admin. Code 4459, subsection 5.5.8.

8.9.2 Must have with them at the work site:

8.9.2.1 Their certification from the Secretary; or

8.9.2.2 Only if they meet the certification requirement at of subsection 8.2, copies of their initial course completion certificate and their most recent refresher course completion certificate.

**History**
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *17 DE Reg. 735 (01/01/14)*
- *26 DE Reg. 699 (02/01/23)*

##### **16 Del. Admin. Code § 4459B-9.0** Suspending, Revoking, or Modifying an Individual's or Firm's Certification {#sec-4459b-9.0 omnilex-key=us-de-regs-official--title-16--4459B-9.0}

9.1 Grounds for suspension, revocation, or modification.

9.1.1 Grounds for suspending, revoking, or modifying an individual's certification. The Secretary may, after notice and opportunity for hearing, suspend, revoke, or modify an individual's certification if:

9.1.1.1 The individual fails to comply with Federal lead-based paint statutes or regulations, or Delaware lead-based paint statutes or regulations.

9.1.1.2 The renovator fails to ensure that all assigned renovations comply with Section 4.0.

9.1.1.3 Obtained training documentation through fraudulent means.

9.1.1.4 Gained admission to and completed an accredited training program through misrepresentation of admission requirements.

9.1.1.5 Obtained certification through misrepresentation of certification requirements or related documents dealing with education, training, professional registration, or experience.

9.1.1.6 Performed work requiring certification at a job site without having proof of certification.

9.1.1.7 Permitted the duplication or use of the individual's own certificate by another.

9.1.1.8 Performed work for which appropriate certification has not been received.

9.1.1.9 Failed to comply with the appropriate work practice standards for lead-based paint activities in Section 4.0.

9.1.1.10 Denied the Secretary access to enter premises or facilities where the certified individual conducts business, including work sites, to execute reasonable inspection, including taking samples, to ensure compliance with regulations.

9.1.2 Grounds for suspending, revoking, or modifying a firm's certification.

9.1.2.1 The Secretary may, after notice and opportunity for hearing, suspend, revoke, or modify a firm's certification if the firm:

9.1.2.1.1 Submits false or misleading information in its application for certification or re-certification.

9.1.2.1.2 Fails to maintain or falsifies records required in Section 5.0.

9.1.2.1.3 Fails to comply, or an individual performing a renovation on behalf of the firm fails to comply, with Federal lead-based paint statutes or regulations or Delaware lead-based paint statutes or regulations.

9.1.2.1.4 Performed work requiring certification at a job site with individuals who are not certified.

9.1.2.1.5 Failed to comply with the work practice standards established in Section 4.0.

9.1.2.1.6 Misrepresented facts in its certification application or letter.

9.1.2.1.7 Failed to maintain required records.

9.1.2.1.8 Denied the Secretary access to enter premises or facilities where the certified firm conducts business, including work sites, to execute reasonable inspection, including taking samples, to ensure compliance with regulations

9.1.3 In addition to an administrative or judicial finding of violation, execution of a consent agreement in settlement of an enforcement action constitutes, for purposes of this section, evidence of a failure to comply with relevant statutes or regulations.

9.2 Process for suspending, revoking, or modifying certification.

9.2.1 Prior to taking action to suspend, revoke, or modify an individual's or firm's certification, the Secretary will notify the affected entity in writing of the following:

9.2.1.1 The legal and factual basis for the proposed suspension, revocation, or modification.

9.2.1.2 The anticipated commencement date and duration of the suspension, revocation, or modification.

9.2.1.3 Actions, if any, which the affected entity may take to avoid suspension, revocation, or modification, or to receive certification in the future.

9.2.1.4 The opportunity and method for requesting a hearing prior to final suspension, revocation, or modification.

9.2.2 If an individual or firm requests a hearing within 20 days of the postmarked date of the Secretary’s notification in subsection 9.2.1, the Secretary will:

9.2.2.1 Provide the affected entity an opportunity to offer written statements in response to Secretary’s assertions of the legal and factual basis for its proposed action, and any other explanations, comments, and arguments it deems relevant to the proposed action.

9.2.2.2 Provide the affected entity such other procedural opportunities as the Secretary may deem appropriate to ensure a fair and impartial hearing.

9.2.2.3 Appoint an official Hearing Officer. No person shall serve as a Hearing Officer if the person has had any prior involvement with the specific matter.

9.2.3 The Hearing Officer will:

9.2.3.1 Conduct a fair, orderly, and impartial hearing within 90 days of the request for a hearing.

9.2.3.2 Consider all relevant evidence, explanation, comment, and argument submitted.

9.2.3.3 Notify the Secretary in writing within 45 days of completion of the hearing of the Hearing Officer's decision. The Secretary shall either accept or reject the decision. If accepted, the Secretary issues a final order within 45 days of receiving the Hearing Officer’s decision. Such an order is a final agency action, which may be subject to judicial review by Superior Court. The order contains the commencement date and duration of the suspension, revocation, or modification.

9.2.4 If the Secretary determines that the public health, interest, or welfare warrants immediate action to suspend the certification of any individual or firm, or if an individual or firm denies the Secretary access for purposes of inspection or taking samples, prior to the opportunity for a hearing, the Secretary will:

9.2.4.1 Notify the affected entity in accordance with paragraph subsections 9.2.1.1 through 9.2.1.3, explaining why it is necessary to suspend the entity's certification before an opportunity for a hearing.

9.2.4.2 Notify the affected entity of its right to request a hearing on the immediate suspension within 15 days of the suspension taking place and the procedures for the conduct of such a hearing.

9.2.5 Any notice, decision, or order issued by the Secretary under this section, any transcript or other verbatim record of oral testimony, and any documents filed by a certified individual or firm in a hearing under this section will be available to the public. Any such hearing at which oral testimony is presented will be open to the public, except that the Presiding Officer may exclude the public to the extent necessary to allow presentation of information which may be entitled to confidential treatment.

9.2.6 The Secretary will maintain a publicly available list of entities whose certification has been suspended, revoked, modified, or reinstated.

9.2.7 Unless the decision and order issued under subsection 9.2.3.3 specify otherwise:

9.2.7.1 An individual whose certification has been suspended must take a refresher training course (Renovator or Dust Wipe Technician) in order to make the individual's certification current.

9.2.7.2 An individual whose certification has been revoked must take an initial Renovator or Dust Wipe Technician course in order to become certified again.

9.2.7.3 A firm whose certification has been revoked must reapply for certification after the revocation ends in order to become certified again. If the firm's certification has been suspended and the suspension ends less than two (2) years after the firm was initially certified or re-certified, the firm does not need to do anything to re-activate its certification.

**History**
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *17 DE Reg. 735 (01/01/14)*
- *26 DE Reg. 699 (02/01/23)*

##### **16 Del. Admin. Code § 4459B-10.0** Fees for the Accreditation of Renovation and Dust Wipe Technician Training, Certification of Renovation Firms, and Certification of Individual Renovators and Dust Wipe Technicians {#sec-4459b-10.0 omnilex-key=us-de-regs-official--title-16--4459B-10.0}

10.1 Persons who must pay fees. Fees in accordance with subsection 10.2 must be paid by:

10.1.1 Training programs. All training programs applying for the accreditation and re-accreditation of training programs in one or more of the following disciplines: Renovator, Dust Wipe Technician.

10.1.2 Firms. All firms applying for certification and re-certification to conduct renovations.

10.1.3 Individuals. All individuals applying for certification and re-certification as Renovators or Dust Wipe Technicians.

10.2 Fee amounts.

10.2.1 Certification and accreditation fees. Initial and renewal certification and accreditation fees are specified as follows:

10.2.1.1 Training Program Accreditation.

10.2.1.1.1 Initial Renovator or Dust Wipe Technician Course Accreditation - $600 for a five-year period.

10.2.1.1.2 Re-accreditation of Initial Renovator or Dust Wipe Technician Course - $600 for a five-year period.

10.2.1.1.3 Refresher Renovator Course or Dust Wipe Technician Course - $600 for a five-year period.

10.2.1.1.4 Re-accreditation of Refresher Dust Wipe Technician Course - $600 for a five-year period.

10.2.1.2 Renovation Firm Certification.

10.2.1.2.1 Initial certification - $300 for a five-year period.

10.2.1.2.2 Re-certification - $300 for a five-year period.

10.2.1.3 Individual Renovator and Dust Wipe Technician Certification.

10.2.1.3.1 Initial certification - $100 for a five-year period.

10.2.1.3.2 Re-certification - $100 for a five-year period.

10.2.2 Accreditation or certification amendments. No fee will be charged for accreditation or certification amendments.

10.3 Failure to remit fees.

10.3.1 The Secretary will not provide certification, re-certification, accreditation, or re-accreditation for any training program, firm, or individual that does not remit fees described in subsection 10.2 in accordance with the procedures specified in Section 7.0.

**History**
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *17 DE Reg. 735 (01/01/14)*
- *26 DE Reg. 699 (02/01/23)*

##### **16 Del. Admin. Code § 4459B-11.0** Accreditation of Training Programs and Application and Renewal Requirements {#sec-4459b-11.0 omnilex-key=us-de-regs-official--title-16--4459B-11.0}

11.1 Accreditation of training programs. On or after the effective date of these regulations, it shall be unlawful for any person or firm to provide, offer to provide, or claim to provide training in one or more of the following disciplines without first possessing an approval from the Secretary as an accredited training program: Renovator and Dust Wipe Technician.

11.1.1 Accredited training programs shall provide, offer to provide, and claim to provide training only for the disciplines for which they are approved.

11.1.2 The Secretary approves an accredited training program for any firm or business that applies and meets the qualifications specified in these regulations.

11.1.3 A training provider may seek accreditation to offer courses in any of the following disciplines: Renovator and Dust Wipe Technician. A training provider may seek accreditation to offer initial and refresher courses for each of the disciplines.

11.2 Application process. The following are procedures a training provider must follow to receive accreditation to offer Renovator and Dust Wipe Technician courses:

11.2.1 A training provider seeking accreditation shall submit a written application to the Secretary containing the following information:

11.2.1.1 The training provider’s business name, address, and telephone number.

11.2.1.2 Written evidence that the applicant has been approved by the Delaware Department of Education as a training provider.

11.2.1.3 A list of courses for which it is applying for accreditation. For the purposes of this section, courses taught in different languages and electronic learning courses are considered different courses, and each must independently meet the accreditation requirements.

11.2.1.4 A statement signed by the training program manager certifying that the training program meets the requirements established in these regulations. If a training program uses EPA-recommended model training materials, or training materials approved by the Secretary, the training program manager shall include a statement certifying that, as well.

11.2.1.5 The name and documentation of the qualifications of the training program manager.

11.2.1.6 The names and documentation of qualifications of any principal instructors.

11.2.1.7 If a training provider does not use EPA-recommended model training materials or training materials approved by the Secretary, its application for accreditation shall also include:

11.2.1.7.1 A copy of the student and instructor manuals, or other materials to be used for each course.

11.2.1.7.2 A copy of the course agenda for each course.

11.2.1.7.3 When applying for accreditation of a course in a language other than English, a signed statement from a qualified, independent translator that they had compared the course to the English language version and found the translation to be accurate.

11.2.1.8 All training providers shall include in their application for accreditation the following:

11.2.1.8.1 A description of the facilities and equipment to be used for lecture and hands-on training.

11.2.1.8.2 The name, address and location of the training facility.

11.2.1.8.3 A description of the activities and procedures that will be used for conducting the assessment of hands-on skills for each course.

11.2.1.8.4 A copy of the quality control plan as described in subsection 11.3.10.

11.2.1.8.5 A certified check or a check written on a business account in the appropriate amount as provided in Section 10.0 made payable to the Division of Public Health.

11.2.1.8.6 A copy of the course test blueprint for each course.

11.2.2 If a training program meets the requirements in subsection 11.3, then the Secretary will approve the application for accreditation no more than 90 days after receiving a complete application from the training provider. In the case of approval, a certificate of accreditation shall be sent to the applicant. In the case of disapproval, a letter describing the reasons for disapproval shall be sent to the applicant. Prior to disapproval, the Secretary may, at the Secretary’s discretion, work with the applicant to address inadequacies in the application for accreditation. The Secretary, within the 90 day period, may also request additional materials retained by the training provider under subsection 11.9. If the Secretary requests additional materials, the time period for approval may extend beyond 90 days. If a training provider's application is disapproved, the provider may reapply for accreditation at any time. Application fees for disapproved training programs will not be refunded.

11.2.3 A training provider may apply for accreditation to offer courses or refresher courses in as many disciplines as it chooses. A training provider may seek accreditation for additional courses at any time the provider can demonstrate that it meets the requirements of this section.

11.3 Requirements for the accreditation of training programs. For a training provider to obtain accreditation from the Secretary to offer Renovator and Dust Wipe Technician courses, the program must meet the following requirements:

11.3.1 The training program must employ a training manager who has demonstrated experience, education, or training in the construction industry in the areas of lead abatement, painting, carpentry, renovation, remodeling, occupational safety and health or industrial hygiene, and meets one of the following requirements:

11.3.1.1 At least two (2) years of experience, education, or training in teaching workers or adults, that is satisfactory to the Secretary; or

11.3.1.2 A bachelor's or graduate degree in building construction technology, engineering, industrial hygiene, safety, public health, education, business administration or program management, or a related field; or

11.3.1.3 Two years of experience in managing a training program specializing in environmental hazards.

11.3.2 The training manager shall designate a qualified principal instructor for each course who has:

11.3.2.1 Demonstrated experience, education, or training in teaching workers or adults;

11.3.2.2 Successfully completed at least 8 hours of any EPA-accredited or EPA-authorized State or Tribal accredited lead-specified training; and

11.3.2.3 Demonstrated experience, education, or training in lead abatement, painting, carpentry, renovation, remodeling, occupational safety and health, or industrial hygiene.

11.3.3 The principal instructor shall be responsible for the organization of the course, course delivery, and oversight of the teaching of all course material. The training manager may designate guest instructors as needed for a portion of the course to provide instruction specific to the lecture, hands-on activities, or work practice portions of a course. However, the principal instructor is primarily responsible for teaching the course materials and must be present to provide instruction (or oversight of portions of the course taught by guest instructors) for the course for which he has been designated as the principal instructor.

11.3.4 The following documents shall be accepted as evidence that training managers and principal instructors have the education, work experience, training requirements, or demonstrated experience, specifically listed in subsections 11.3.1 and 11.3.2. This documentation must be submitted with the accreditation application and retained by the training program as required by the record keeping requirements contained in 11.9. Those documents include the following:

11.3.4.1 Official academic transcripts or diploma as evidence of meeting the education requirements.

11.3.4.2 Resumes, letters of reference, or documentation of work experience, as evidence of meeting the work experience requirements.

11.3.4.3 Certificates from train-the-trainer courses and lead-specific training courses, as evidence of meeting the training requirements.

11.3.5 The training program shall ensure the availability of, and provide adequate facilities for, the delivery of the lecture, course test, hands-on training, and assessment activities. This includes providing training equipment that reflects current work practices and maintaining or updating the equipment and facilities as needed.

11.3.6 To become accredited in the following disciplines, the training program shall provide training courses that meet the following training requirements.

11.3.6.1 The Initial Renovator course must last a minimum of eight (8) training hours, with a minimum of two (2) hours devoted to hands-on activities. The minimum curriculum requirements for the Initial Renovator course are contained in subsection 11.4.1.

11.3.6.2 The Initial Dust Wipe Technician course must last a minimum of eight (8) training hours, with a minimum of two (2) hours devoted to hands-on activities. The minimum curriculum requirements for the Initial Renovator course are contained in subsection 11.4.2.

11.3.7 Electronic learning and other alternative course delivery methods are permitted for the classroom portion of Renovator or Dust Wipe Technician courses but not the hands-on portion of these courses, or for final course tests or proficiency tests described in subsection 11.3.8. Electronic learning courses must comply with the following requirements:

11.3.7.1 A unique identifier must be assigned to each student for them to use to launch and re-launch the course.

11.3.7.2 The training provider must track each student's course logins, launches, progress, and completion, and maintain these records as required in subsection 11.9.

11.3.7.3 The course must include periodic knowledge checks equivalent to the number and content of the knowledge checks contained in EPA's model course, but at least 16 over the entire course. The knowledge checks must be successfully completed before the student can go on to the next module.

11.3.7.4 There must be a test of at least 20 questions at the end of the electronic learning portion of the course, of which 80% must be answered correctly by the student for successful completion of the electronic learning portion of the course. The test must be designed so that students do not receive feedback on their test answers until after they have completed and submitted the test.

11.3.7.5 Each student must be able to save or print a copy of an electronic learning course completion certificate. The electronic certificate must not be susceptible to easy editing.

11.3.8 For each course offered, the training program shall conduct either a course test at the completion of the course, and if applicable, a hands-on skills assessment, or in the alternative, a proficiency test for that discipline. Each student must successfully complete the hands-on skills assessment and receive a passing score on the course test to pass any course, or successfully complete a proficiency test.

11.3.8.1 The training manager is responsible for maintaining the validity and integrity of the hands-on skills assessment or proficiency test to ensure that it accurately evaluates the trainees' performance of the work practices and procedures associated with the course topics. For quality assurance, there will be periodic revision of the course assessment or proficiency test.

11.3.8.2 The training manager is responsible for maintaining the validity and integrity of the course test to ensure that it accurately evaluates the trainees' knowledge and retention of the course topics. For quality assurance, there shall be periodic revision of the course assessment or proficiency test. The course test blueprint shall be submitted to the Secretary.

11.3.8.3 The course test shall be developed in accordance with the test blueprint submitted with the training accreditation application.

11.3.9 The training program shall issue unique course completion certificates to each individual who passes the training course. The course completion certificate shall include:

11.3.9.1 The name, unique identification number, and address of the individual.

11.3.9.2 The business name, address and phone number of the accredited training program provider and program, and the name of the training manager.

11.3.9.3 The name of the particular course that the individual completed.

11.3.9.4 Date of course completion/test passage.

11.3.9.5 The language in which the course was taught.

11.3.9.6 A photograph of the individual. The photograph must be an accurate and recognizable image of the individual. As reproduced on the certificate, the photograph must not be smaller than one (1) square inch.

11.3.10 The training manager shall develop and implement a quality control plan. The plan shall be used to maintain and improve the quality of the training program over time. This plan shall contain at least the following elements:

11.3.10.1 Procedures for periodic revision of training materials and the course test to reflect innovations in the field.

11.3.10.2 Procedures for the training manager's annual review of principal instructor competency.

11.3.11 The training program must offer courses that teach the applicable work practice standards in Section 4.0 for conducting renovations. These standards must be taught in the appropriate courses and training environments to provide trainees with the knowledge needed to perform the activities they are responsible for conducting.

11.3.12 The training manager shall be responsible for ensuring that the training program complies at all times with all of the requirements in this section.

11.3.13 The training provider and training manager must allow the Secretary to conduct, at the Secretary’s discretion, either announced or unannounced audits of the training program to verify the contents of the application for accreditation as described in subsection 11.2 and to confirm compliance with all program accreditation requirements.

11.3.14 The training manager must provide notification of the courses offered.

11.3.14.1 The training manager must provide the Secretary with notification of all Renovator and Dust Wipe Technician courses offered. The Secretary must receive the original notification at least seven (7) business days prior to the start date of any Renovator and Dust Wipe Technician courses.

11.3.14.2 The training manager must provide the Secretary updated notification when Renovator and Dust Wipe Technician courses will begin on a date other than the start date specified in the original notification, as follows:

11.3.14.2.1 For Renovator and Dust Wipe Technician courses beginning prior to the start date provided to the Secretary, an updated notification must be received by the Secretary at least seven (7) business days before the new start date.

11.3.14.2.2 For Renovator and Dust Wipe Technician courses beginning after the start date provided to the Secretary, an updated notification must be received by the Secretary at least two (2) business days before the start date provided to the Secretary.

11.3.14.2.3 The training manager must update the Secretary of any change in location of Renovator and Dust Wipe Technician courses at least seven (7) business days prior to the start date provided to the Secretary.

11.3.14.2.4 The training manager must update the Secretary regarding any course cancellations, or any other change to the original notification. Updated notifications must be received by the Secretary at least two (2) business days prior to the start date provided to the Secretary.

11.3.14.2.5 Each notification, including updates, must include the following:

11.3.14.2.5.1 Notification type (original, update, cancellation).

11.3.14.2.5.2 Training program name, the Delaware accreditation number, address, and telephone number.

11.3.14.2.5.3 Course discipline, type (initial/refresher), and the language in which the instruction will be given.

11.3.14.2.5.4 Date and time of training.

11.3.14.2.5.5 Training location, telephone number, and address.

11.3.14.2.5.6 Principal instructor's name.

11.3.14.2.5.7 Training manager's name and signature.

11.3.14.2.6 Notification must be accomplished using any of the following methods: Written or electronic notification to the Secretary. Written and electronic notifications of lead-based paint activities course schedules can be accomplished by using the guidance and sample form provided online at http://dhss.delaware.gov/dhss/dph/hsp/leadregcomm.html. All written notifications must be delivered by U.S. Postal Service, fax, commercial delivery service, or hand delivery (persons submitting notification by U.S. Postal Service are reminded that they should allow three (3) additional business days for delivery in order to ensure that the Secretary receives the notification by the required date).

11.3.14.2.7 Renovator and Dust Wipe Technician courses must not begin on a date, or at a location other than that specified in the original notification unless an updated notification identifying a new start date or location is submitted, in which case the course must begin on the new start date or location specified in the updated notification.

11.3.14.2.8 No training program shall provide Renovator and Dust Wipe Technician courses without first notifying the Secretary of such activities in accordance with the requirements of subsection 11.3.14.

11.3.15 The training manager must provide notification following completion of Renovator and Dust Wipe Technician courses.

11.3.15.1 The training manager must provide the Secretary notification after the completion of any Renovator and Dust Wipe Technician course. This notice must be received by the Secretary no later than 10 business days following course completion.

11.3.15.2 The notification must include the following:

11.3.15.2.1 Training program name, the Delaware accreditation number, address, and telephone number.

11.3.15.2.2 Course discipline and type (initial/refresher).

11.3.15.2.3 Date of training.

11.3.15.2.4 The following information for each student who took the course:

11.3.15.2.4.1 Name.

11.3.15.2.4.2 Address.

11.3.15.2.4.3 Date of birth.

11.3.15.2.4.4 Course completion certificate number.

11.3.15.2.4.5 Course test score.

11.3.15.2.4.6 A digital photograph of the student.

11.3.15.2.5 Training manager's name and signature.

11.3.15.3 Notification must be accomplished using any of the following methods: Written or electronic notification to the Secretary. Written and electronic notifications following lead-based paint activities training courses can be accomplished by using the guidance and sample form provided online at http://dhss.delaware.gov/dhss/dph/hsp/leadregcomm.html. All written notifications must be delivered by U.S. Postal Service, fax, commercial delivery service, or hand delivery (persons submitting notification by U.S. Postal Service are reminded that they should allow three (3) additional business days for delivery in order to ensure that the Secretary receives the notification by the required date).

11.4 Minimum training curriculum requirements. To become accredited to offer lead-based paint courses in the specific disciplines listed in this Section, training programs must ensure that their courses of study include, at a minimum, the following course topics.

11.4.1 Renovator. Instruction in the topics described in subsections 11.4.1.4, 11.4.1.6, 11.4.1.7, and 11.4.1.8 must be included in the hands-on portion of the course.

11.4.1.1 Role and responsibility of a renovator.

11.4.1.2 Background information on lead and its adverse health effects.

11.4.1.3 Background information on Federal, State of Delaware, and local regulations and guidance that pertains to lead-based paint and renovation activities.

11.4.1.4 Procedures for using acceptable test kits to determine whether paint is lead-based paint.

11.4.1.5 Procedures for collecting a paint chip sample and sending it to a laboratory recognized by EPA under section 405(b) of TSCA.

11.4.1.6 Renovation methods to minimize the creation of dust and lead-based paint hazards.

11.4.1.7 Interior and exterior containment and cleanup methods.

11.4.1.8 Methods to ensure that the renovation has been properly completed, including cleaning verification and clearance testing.

11.4.1.9 Waste handling and disposal.

11.4.1.10 Providing on-the-job training to other workers

11.4.1.11 Record preparation.

11.4.2 Dust Wipe Technician. Instruction in the topics described in subsections 11.4.1.4 and 11.4.1.6 must be included in the hands-on portion of the course.

11.4.2.1 Role and responsibility of a Dust Wipe Technician.

11.4.2.2 Background information on lead and its adverse health effects.

11.4.2.3 Background information on Federal, State of Delaware, and local regulations and guidance that pertains to lead-based paint and renovation activities.

11.4.2.4 Dust sampling methodologies.

11.4.2.5 Clearance standards and testing.

11.4.2.6 Record preparation.

11.5 Requirements for the accreditation of refresher training programs. A training provider may seek accreditation to offer refresher training courses in any of the following disciplines: Renovator and Dust Wipe Technician. To obtain accreditation to offer refresher training, a training provider must meet the following minimum requirements.

11.5.1 Refresher courses shall review the curriculum topics of the full-length course listed under subsection 3.5, as appropriate. In addition, to become accredited to offer refresher training courses, training providers shall ensure their courses of study include, at a minimum, the following:

11.5.1.1 An overview of current safety practices relating to lead-based paint in general, as well as specific information pertaining to the appropriate discipline.

11.5.1.2 Current laws and regulations relating to lead-based paint in general, as well as specific information pertaining to the appropriate discipline.

11.5.1.3 Current technologies relating to lead-based paint in general, as well as specific information pertaining to the appropriate discipline.

11.5.2 Refresher course must last a minimum of four (4) training hours. Refresher courses must include a hands-on component.

11.5.3 For each refresher course offered, the training provider must conduct a hands-on assessment, and at the completion of the course, a course test.

11.5.4 A training provider may apply for accreditation of a refresher course concurrently with its application for accreditation of the corresponding initial training course as described in subsection 11.2. If so, the Secretary shall use the approval process described in subsection 11.2. In addition, the minimum requirements contained in subsections 11.3.1 through 11.3.5 and subsections 11.3.8 through 11.3.15, and subsections 11.5.1.1 through 11.5.1.3 shall also apply to the refresher course.

11.5.5 A training provider seeking accreditation to offer refresher training courses only must submit to the Secretary a written application containing the following information:

11.5.5.1 The refresher course training provider's name, address, and telephone number.

11.5.5.2 A list of courses for which it is applying for accreditation.

11.5.5.3 The name and documentation of the qualifications of the training program manager.

11.5.5.4 The name and documentation of the qualifications of the principal instructor.

11.5.5.5 A statement signed by the training program manager certifying that the refresher training program meets the requirements established in subsection 11.3, except for the requirements in subsection 11.3.6. If a training program uses EPA-recommended model training materials, or training materials approved by the Secretary, the training program manager shall include a statement certifying that, as well.

11.5.5.6 If the refresher training course materials are not based on EPA-developed training materials or training materials approved by the Secretary, the training provider's application for accreditation shall include:

11.5.5.6.1 A copy of the student and instructor manuals to be used for each course.

11.5.5.6.2 A copy of the course agenda for each course.

11.5.5.7 All refresher training providers shall include in their application for accreditation the following:

11.5.5.7.1 A description of the facilities and equipment to be used for lecture and hands-on training.

11.5.5.7.2 The name, address and location of the training facility.

11.5.5.7.3 A description of the activities and procedures that will be used for conducting the assessment of hands-on skills for each course.

11.5.5.7.4 A copy of the quality control plan as described in subsection 11.3.10.

11.5.5.7.5 A certified check or a check written on a business account in the appropriate amount as provided in Section 10.0 made payable to the Division of Public Health.

11.5.5.7.6 A copy of the course test blueprint for each course.

11.5.5.8 The requirements in subsections 11.3.1 through 11.3.5 and subsections 11.3.8 through 11.3.15 apply to refresher training providers.

11.5.5.9 If a refresher training program meets the requirements in subsection 11.5 the Secretary shall approve the application for accreditation no more than 90 days after receiving a complete application from the refresher training provider. In the case of approval, a certificate of accreditation shall be sent to the applicant. In the case of disapproval, a letter describing the reasons for disapproval shall be sent to the applicant. Prior to disapproval, the Secretary may, at the Secretary’s discretion, work with the applicant to address inadequacies in the application for accreditation. The Secretary, within the 90-day period, may also request additional materials. If the Secretary requests additional materials, the time period for approval may extend beyond 90 days. The Secretary may also request additional materials retained by the refresher training program under subsection 11.9. If a refresher training provider's application is disapproved, the program provider may reapply for accreditation at any time. Application fees for disapproved refresher training programs will not be refunded.

11.6 Re-accreditation of training programs.

11.6.1 Unless re-accredited, a training program’s accreditation (including refresher training accreditation) shall expire 5 years after the date of issuance. If a training program meets the requirements of this section, the training program shall be re-accredited.

11.6.2 A training provider seeking program re-accreditation shall submit an application to the Secretary no later than 180 days before its accreditation expires. If a training provider does not submit its application for re-accreditation by that date, the Secretary cannot guarantee that the program will be re-accredited before the end of the accreditation period.

11.6.3 The training provider’s application for program re-accreditation shall contain:

11.6.3.1 The training provider's name, address, and telephone number.

11.6.3.2 A list of courses for which it is applying for re-accreditation.

11.6.3.3 The name and qualifications of the training program manager.

11.6.3.4 The names and qualifications of the principal instructors.

11.6.3.5 A description of any changes to the training facility, equipment, or course materials since its last application was approved that adversely affects the students’ ability to learn.

11.6.3.6 A statement signed by the program manager stating:

10.6.3.6.1 That the training program complies at all times with all requirements in subsections 11.3 and 11.5, as applicable; and

10.6.3.6.2 The record keeping and reporting requirements in subsection 11.9 shall be followed.

11.6.3.7 A certified check or a check written on a business account in the appropriate amount as provided in Section 10.0 made payable to the Division of Public Health.

11.6.4 The Secretary has the authority to audit the training program to verify the contents of the application for reaccreditation as described in subsection 11.6.3. The training provider shall allow the Secretary to audit the training program.

11.7 Suspension, revocation and modification of accredited training programs.

11.7.1 The Secretary may, after notice and an opportunity for hearing, suspend, revoke, or modify training provider or program accreditation, including refresher training accreditation, if a training provider, training manager, or other person with supervisory authority over the training program has:

11.7.1.1 Misrepresented the contents of a training course to the Secretary or the student population.

11.7.1.2 Failed to submit required information or notifications in a timely manner.

11.7.1.3 Failed to maintain required records.

11.7.1.4 Falsified accreditation records, instructor qualifications, or other accreditation-related information or documentation.

11.7.1.5 Failed to comply with the training standards and requirements in this section.

11.7.1.6 Failed to comply with Federal, State of Delaware, or local lead-based paint statutes or regulations.

11.7.1.7 Made false or misleading statements in its application for accreditation or re-accreditation which the Secretary relied upon in approving the application.

11.7.1.8 Denied the Secretary access to enter premises or facilities where training providers and training programs conduct business to execute reasonable inspection to ensure compliance with regulations.

11.7.2 In addition to an administrative or judicial finding of violation in any jurisdiction, execution of a consent agreement in settlement of an enforcement action constitutes, for purposes of this section, evidence of a failure to comply with relevant statutes or regulations.

11.8 Procedures for suspension, revocation, or modification of training program accreditation.

11.8.1 Prior to taking action to suspend, revoke, or modify the accreditation of a training provider or program, the Secretary shall notify the affected entity in writing of the following:

11.8.1.1 The legal and factual basis for the suspension, revocation, or modification.

11.8.1.2 The anticipated commencement date and duration of suspension, revocation, or modification.

11.8.1.3 Actions, if any, which the affected entity may take to avoid suspension, revocation, or modification, or to receive accreditation in the future.

11.8.1.4 The opportunity and method for requesting a hearing prior to final action to suspend, revoke, or modify accreditation.

11.8.1.5 Any additional information which the Secretary may provide.

11.8.2 If a hearing is requested by the accredited training provider within 20 days of the postmarked date of the Secretary’s notification in subsection 11.8.1, the Secretary shall:

11.8.2.1 Provide the affected entity an opportunity to offer written statements in response to the Secretary's assertions of the legal and factual basis for its proposed action, and any other explanations, comments, and arguments it deems relevant to the proposed action.

11.8.2.2 Provide the affected entity such other procedural opportunities as the Secretary may deem appropriate to ensure a fair and impartial hearing.

11.8.2.3 Appoint an official Hearing Officer to conduct the hearing. No person shall serve as Hearing Officer if the person has had any prior involvement with the specific matter.

11.8.3 The Hearing Officer appointed pursuant to subsection 11.8.2 shall:

11.8.3.1 Conduct a fair, orderly, and impartial hearing within 90 days of the request for a hearing.

11.8.3.2 Consider all relevant evidence, explanation, comment, and argument submitted.

11.8.3.3 Notify the Secretary in writing within 45 days of completion of the hearing of the Hearing Officer's decision. The Secretary shall either accept or reject the decision. If accepted, the Secretary issues a final order within 45 days of receiving the Hearing Officer’s decision. Such an order is a final agency action, which may be subject to judicial review by Superior Court.

11.8.4 If the Secretary determines that the public health, interest, or welfare warrants immediate action to suspend the accreditation of any training provider or program prior to the opportunity for a hearing, or if the training provider or program denies the Secretary access for purposes of inspection, the Secretary shall:

11.8.4.1 Notify the affected entity of its intent to immediately suspend training program accreditation for the reasons listed in subsection 11.7.1. If a suspension, revocation, or modification notice has not previously been issued pursuant to subsection 11.7.1, it shall be issued at the same time the emergency suspension notice is issued.

11.8.4.2 Notify the affected entity in writing of the grounds for the immediate suspension and why it is necessary to suspend the entity's accreditation before an opportunity for a suspension, revocation, or modification hearing.

11.8.4.3 Notify the affected entity of the anticipated commencement date and duration of the immediate suspension.

11.8.4.4 Notify the affected entity of its right to request a hearing on the immediate suspension within 15 days of the suspension taking place and the procedures for the conduct of such a hearing.

11.8.5 Any notice, decision, or order issued by the Secretary under this section, any transcripts or other verbatim record of oral testimony, and any documents filed by an accredited training provider in a hearing under this section shall be available to the public. Any such hearing at which oral testimony is presented shall be open to the public, except that the Hearing Officer may exclude the public to the extent necessary to allow presentation of information which may be entitled to confidential treatment.

11.8.6 The public shall be notified of the suspension, revocation, modification, or reinstatement of a training program's accreditation through appropriate mechanisms.

11.8.7 The Secretary shall maintain a list of parties whose accreditation has been suspended, revoked, modified, or reinstated.

11.9 Training program record keeping requirements.

11.9.1 Accredited training providers shall maintain, and make available to the Secretary, upon request, the following records:

11.9.1.1 All documents specified in subsection 11.3.4 that demonstrate the qualifications of the training manager and principal instructors listed in subsections 11.3.1 and 11.3.2.

11.9.1.2 Current curriculum/course materials and documents reflecting any changes made to these materials.

11.9.1.3 Information regarding how the hands-on assessment is conducted, including, but not limited to:

11.9.1.3.1 Who conducts the assessment.

11.9.1.3.2 How the skills are graded.

11.9.1.3.3 What facilities are used.

11.9.1.3.4 The pass/fail rate.

11.9.1.4 The quality control plan as described in subsection 11.3.10.

11.9.1.5 Results of the students' hands-on skills assessments and course tests, and a record of each student's course completion certificate.

11.9.1.6 The course test blueprint.

11.9.1.7 Any other material not listed above in subsections 11.9.1.1 through 11.9.1.6 that was submitted to the Secretary as part of the program's application for accreditation.

11.9.1.8 For Renovator refresher and Dust Wipe Technician refresher courses, a copy of each trainee's prior course completion certificate showing that each trainee was eligible to take the refresher course.

11.9.1.9 For course modules delivered in an electronic format, a record of each student's logins, launches, progress, and completion, and a copy of the electronic learning completion certificate for each student.

11.9.2 The training provider shall retain these records at the address specified on the training provider accreditation application or as modified in accordance with subsection 11.9.3 for a minimum of three years and six months.

11.9.3 The training provider shall notify the Secretary in writing within 30 days of changing the address specified on its training program accreditation application or transferring the records from that address.

11.10 Amendment of accreditation.

11.10.1 A training provider must amend its program accreditation within 90 days of the date a change occurs to information included in the program’s most recent application. If the training provider fails to amend its program accreditation within 90 days of the date the change occurs, the program may not provide Renovator or Dust Wipe Technician training until its accreditation is amended.

11.10.2 To amend an accreditation, a training provider must submit a completed application form approved by the Secretary and signed by an authorized agent of the training provider, noting on the form that it is submitted as an amendment and indicating the information that has changed.

11.10.3 If the amendment includes a new training program manager, any new or additional principal instructors, or any new permanent training locations, the training provider is not permitted to provide training under the new training manager or offer courses taught by any new principal instructors or at the new training locations until the Secretary approves the amendment. Except:

11.10.3.1 If the amendment includes a new training program manager or new or additional principal instructor that was identified in a training provider accreditation application that EPA has already approved under this section, the training provider may begin to provide training under the new training manager or offer courses taught by the new principal instructor on an interim basis as soon as the provider submits the amendment to the Secretary. The training provider may continue to provide training under the new training manager or offer courses taught by the new principal instructor if the Secretary approves the amendment, or does not disapprove the amendment within 30 days.

11.10.3.2 If the amendment includes a new permanent training location, the training provider may begin to provide training at the new permanent training location on an interim basis as soon as the provider submits the amendment to the Secretary. The training provider may continue to provide training at the new permanent training location if the Secretary approves the amendment or does not disapprove the amendment within 30 days.

**History**
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *17 DE Reg. 735 (01/01/14)*
- *26 DE Reg. 699 (02/01/23)*

##### **16 Del. Admin. Code § 4459B-12.0** Inspections {#sec-4459b-12.0 omnilex-key=us-de-regs-official--title-16--4459B-12.0}

To execute reasonable inspections and ensure compliance with these regulations, the Secretary has the authority to enter premises or facilities where certified firms and training programs conduct business and training programs.

**History**
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *26 DE Reg. 699 (02/01/23)*
- *17 DE Reg. 735 (01/01/14)*
- *26 DE Reg. 699 (02/01/23)*

#### **4462** Public Drinking Water Systems

##### **16 Del. Admin. Code § 4462-1.0** General Provisions {#sec-4462-1.0 omnilex-key=us-de-regs-official--title-16--4462-1.0}

1.1 Application. These regulations shall apply to all public water systems in the State of Delaware.

1.2 Variance. Variances will not be issued under these regulations.

1.3 Exemption. Exemptions will not be issued under these regulations.

1.4-1.5 Missing section numbers are reserved.

1.6 Right of Entry: The Director of the Division or their designee shall have the right of entry, during reasonable hours and in a reasonable manner and without fee or hindrance, for the purpose of conducting a sanitary survey and/or sampling of any public water supply and all water furnished by any public water supplier, whether or not the Division has evidence that the system is in violation of an applicable legal requirement.

1.7 Prohibiting Water Usage: The Division may prohibit the use of sources of water which after treatment do not provide water conforming to the standards established by these regulations or which for any reason may pose a threat to the public's health.

1.8 Separability: If any provision of these regulations is held invalid, such invalidity shall not affect other provisions which can be given effect without the invalid provision.

1.9 Enforcement of Regulations:

1.9.1 All PWSs must be operated in compliance with the requirements as set forth in these regulations.

1.9.1.1 Notice: Whenever the Director of the Division, or their appointed representative, has reason to believe that a violation of any of these regulations has occurred or is occurring; the Division shall notify the alleged violator. Such notice shall be in writing, may be sent by Certified Mail, or hand delivered, shall cite the regulation or regulations that are allegedly being violated, and shall state the facts which form the basis for believing that the violation has occurred or is occurring.

1.9.1.2 Orders: Notice of a violation may be accompanied by an order that requires that certain corrective action be taken. The order shall be signed by the Director or their designee or any of their appointed representatives and may require:

1.9.1.2.1 The immediate cessation or correction of the violation.

1.9.1.2.2 The acquisition or use of additional equipment, supplies or personnel to ensure that the violation does not recur.

1.9.1.2.3 The submission of a plan to prevent future violations to the Division for review and approval.

1.9.1.2.4 Any other corrective action deemed necessary for proper compliance with the regulations including interim remedies pending correction of violations.

1.9.1.3 Hearing Request: Any supplier of water who receives an order from the Division may submit a request for a hearing to the Secretary, Delaware Health and Social Services to contest the order.

1.9.1.4 Compliance with Effective Orders: Should any public water supplier fail to comply with any of these regulations, the Secretary, Delaware Health and Social Services may apply to an appropriate court for an injunction or other legal process to prevent or stop any practice which is in violation of these regulations.

1.9.1.5 Penalties: The Secretary, Delaware Health and Social Services shall have the authority to impose an administrative penalty upon any public water system that refuses, fails or neglects to perform the duties required of it pursuant to Title 16, Chapter 1, §122(3)c. The administrative penalty shall be as follows:

1.9.5.1.1 For systems serving a population of more than 10,000 people, not less than $1,000 nor more than $10,000 per day per violation; and

1.9.5.1.2 For any other system, the administrative penalty shall be not less than $100 or more than $10,000 per day per violation.

1.10 Emergency Orders: The Director of the Division or their appointed representative may issue emergency orders in any case where there is an imminent danger to the health of the public resulting from the operation of any waterworks or the source of a water supply. An emergency order may be communicated by the best practical notice under the circumstances and is effective immediately upon receipt. The order may state any requirements necessary to remove the danger to the health of the public, including the immediate cessation of the operation of the PWS. Emergency orders shall be effective for a period not exceeding sixty (60) days at the determination of the Director of the Division or their representative. Should any public water supplier fail to comply with an emergency order, the Secretary, Delaware Health and Social Services may apply to an appropriate court for an injunction or other legal process to prevent or stop any practice which is in violation of these regulations.

1.11 Plans and Specifications:

1.11.1 No person shall construct a new PWS or alter an existing PWS without a Certificate of Approval for Construction.

1.11.1.1 Systems shall submit two (2) copies of plans and specifications. Plans shall be developed using Construction Plans and Specifications Submittal and Review Guidelines (copies are available from the Office of Drinking Water), utilizing the latest edition of Ten States Standards, National Sanitation Foundation (NSF) Standards, American Water Works Association (AWWA) Standards, or approved equivalent and other technical information as required by the Division.

1.11.1.2 Construction shall be in accordance with the approved plans and all conditions listed in the Certificate of Approval to Construct.

1.11.1.3 Whenever it is discovered that either of the above are occurring without such approval, the Director of the Division may order the owner, supplier of water or contractor to immediately stop the work and submit plans and specifications to the Division. After the submittal, any part of the system that has already been installed and is not in compliance shall be removed, altered or replaced in order to achieve compliance.

1.11.1.4 Plans and specifications shall be on paper no larger than 30" x 42". Within thirty (30) days of receipt of plans and specifications, the Division shall notify the person who submitted the plans and specifications if they have been approved or disapproved. Such notice shall specify any conditions of approval or any reasons for disapproval. Approvals are valid for one (1) year and construction shall begin within that time. All construction shall be in accordance with the approved plans and all conditions listed in the Certificate of Approval.

1.11.2 Effective October 1, 1999, all new community and non-transient non-community systems must comply with subsection 1.11.1, and, in addition, submit an Application for Capacity Development review. The application is available from the Office of Drinking Water.

1.12 Approval of Water Supplies:

1.12.1 No person shall operate a newly constructed public water system or renovated portion of an existing water system without a Certificate of Approval to Operate. A Certificate of Approval to Operate shall be issued by the Division to water systems which meet the following requirements:

1.12.1.1 Compliance with rules and regulations to prevent development of health hazards;

1.12.1.2 Adequate protection of the water quality throughout all parts of the system, as demonstrated by sanitary surveys;

1.12.1.3 Proper operation of the water supply system under the responsible charge of personnel whose qualifications meet the certification requirements of the Division;

1.12.1.4 Adequate capacity to meet anticipated peak demands while maintaining not less than twenty-five (25) pounds per square inch (psi) and not more than one hundred (100) psi at ground level at all points in the water distribution system and;

1.12.1.5 Records of laboratory examinations showing compliance with the water quality requirements of these regulations.

1.12.1.5.1 Submission of as-built plans per the Construction Plans and Specifications Submittal and Review Guidelines, copies available from the Office of Drinking Water.

1.12.2 Effective October 1, 1999, in addition to the requirements in subsection 1.12.1, approval of new community and non-transient non-community water systems shall be dependent upon the following:

1.12.2.1 A certification by a professional engineer that the system was built in accordance with approved plans and specifications and all conditions of the Certificate of Approval to Construct; and

1.12.2.2 Managerial and financial information as required by the Division to demonstrate compliance with Capacity as defined in Section 2.0. This information may include, but not be limited to; annual reports, water system plans or business plans, self-assessments/peer reviews, criteria used by lenders, financial viability assessment methods, financial and managerial training.

1.12.2.3 Failure to comply with subsections 1.12.2.1 and 1.12.2.2 shall result in the Division denying the application for a Certificate of Approval to Operate. A new water system shall not commence operations without a Certificate of Approval to Operate.

1.13 Siting Requirements:

1.13.1 Before any person may enter into a financial commitment for or initiate construction of a new PWS or increase the capacity of an existing PWS, the person shall notify the Division and, to the extent practicable, avoid locating part or all of the new or expanded facility at a site which:

1.13.1.1 Is subject to a significant risk from earthquakes, floods, fires or other disasters which could cause a breakdown of the PWS or a portion thereof or;

1.13.1.2 Except for intake structures, is within the floodplain of a one hundred (100) year flood or is lower than any recorded high tide where appropriate records exist.

1.14 Approved Laboratory:

1.14.1 For the purpose of determining compliance with subsection 1.12.1.5 and Sections 7.0, 8.0, 9.0, 10.0, 13.0, 15.0, 16.0, 17.0, 18.0, and 21.0 samples may be considered only if they have been analyzed by the Division, EPA, or an approved laboratory, except that measurements for alkalinity, calcium, conductivity, disinfectant residual, orthophosphate, silica, turbidity, free chlorine residual, temperature and pH may be performed by any person acceptable to the Division.

1.14.2 Laboratory Certification Process: Continuation of laboratory certification for conducting drinking water analyses is contingent upon successful, on-going compliance with the most recent edition of the “Manual for the Certification of Laboratories Analyzing Drinking Water.” Copies are available from the Office of Drinking Water.

1.14.3 Annual laboratory proficiency testing:

1.14.3.1 In order to demonstrate proficiency a laboratory shall successfully analyze a proficiency test (PT) from an approved provider annually using the same analytical method that is used to report compliance-monitoring results. In order to receive and maintain certification for an analyte, the laboratory shall successfully analyze PT samples using EPA-approved methods in accordance with 40 CFR 41 (copies are available from the Office of Drinking Water) for each analyte (microbiological and/or chemical) and by each method used to analyze compliance samples.

1.14.3.2 In order to receive annual certification, laboratories located in Delaware, shall complete a PT in the first quarter of the calendar year. Failure to complete the PT within the first quarter will result in the laboratory status being downgraded to “provisional”. If a laboratory fails to get an acceptable result on a PT then they shall complete a make-up PT for those analytes that were unacceptable in the original PT within 60 days of the notification by the Division. Failure to successfully complete the make-up PT will result in the laboratories status being downgraded to “not certified.”

1.14.3.3 In order for the Division to accept compliance results from laboratories located outside of Delaware, the laboratory must comply with the requirements of their home state. In addition, they must submit copies of their home state certification, copies of the last two PTs and a copy of their Quality Assurance program prior to or at the time that compliance samples are submitted to the Division.

1.14.3.4 Annual certified analyte lists for in-state laboratories will be issued on July 1 of each year and expire on June 30 of the following year.

1.14.4 Reporting by laboratories: Laboratories that analyze compliance samples for public water systems in Delaware must report the results to the public water system in a timely manner and if a MCL or Action Level (AL) exceedance occurs then the Office of Drinking Water must be notified in accordance with the following:

1.14.4.1 Microbiological samples: If the original sample or one or more repeat samples are positive for fecal coliforms or E. coli, the laboratory must report the results by the end of the business day, or if it is after business hours, then by then end of the next business day.

1.14.4.2 Chemical samples: If a sample exceeds an MCL or AL as specified in these regulations the laboratory must report the results by the end of the business day, or if it is after business hours, then by the end of the next business day.

1.14.5 Notification of major changes: Certified laboratories must notify the Division, in writing, within 30 days of major changes in personnel that impact who is conducting the analysis, new equipment, new methods being used, or laboratory re-location.

1.14.6 Chain of Custody: Chain of custody forms must accompany all samples. If an intermediate location is utilized during transportation to the laboratory then the sample(s) must be stored in a locked refrigerator or sealed with a tamper-evident label.

1.15 Quality. Drinking water shall not contain impurities in concentrations which may be hazardous to the health of the consumers. Substances used in its treatment shall not remain in the water in concentrations greater than required by good practice. Substances which may have deleterious physiological effects, or for which physiological effects are not known, shall not be introduced into the system in a manner which would permit them to reach the consumer. For the purpose of these regulations interim health-based standards shall be set by the Division on a case-by-case basis at a level between 10-4 to 10-6 risk level for those contaminants that are potential carcinogens and a Hazard Quotient of 1 to 10 for non-cancer health effects based on the best available science at the time. These standards shall be enforceable. For the purpose of these regulations Hazard Quotient shall mean expressions applied to modeled human health risk values associated with exposures to systemic, non-cancer causing contaminants.

1.16 Required Sampling, Monitoring or Analyses:

1.16.1 In any case where the Division does not perform sampling, monitoring or analyses required by these regulations, the supplier of water shall be responsible for performing this sampling, monitoring or analyses.

1.16.2 Monitoring of consecutive public water systems: When a public water system supplies water to one or more other public water systems, the Division may modify the monitoring requirements imposed by these regulations to the extent that the interconnection of the systems justifies treating them as a single system for monitoring purposes. Any modified monitoring shall be conducted pursuant to a schedule specified by the Division and concurred with by the Administrator of the US Environmental Protection Agency.

1.17 Use of Bottled Water. Public water systems shall not use bottled water to achieve compliance with an MCL. Bottled water may be used on a temporary basis to avoid unreasonable risk to health.

1.18 Regulatory Classification:

1.18.1 All public water systems shall:

1.18.1.1 Meet all bacteriological requirements;

1.18.1.2 Meet the nitrate and nitrite requirements; and

1.18.1.3 Conform to provisions of Section 7.0.

1.18.2 All community and non-transient non-community public water systems as defined in Section 2.0 shall:

1.18.2.1 Meet all the requirements of subsection 1.18.1;

1.18.2.2 Meet all other Primary Standards; and

1.18.2.3 Meet all requirements of Sections 10.0, 11.0, 12.0, 13.0, 14.0, 15.0, 16.0 (community water systems only), 17.0, 18.0, 19.0, 20.0 and 21.0.

1.18.3 All community public water systems as defined in Section 2.0 and that serve more than 500 service connections within the state shall:

1.18.3.1 Meet all requirements of subsection 1.18.1;

1.18.3.2 Meet all requirements of subsection 1.18.2; and

1.18.3.3 Meet all other primary and secondary standards.

1.19 Disinfection

1.19.1 When it is specifically required by these regulations, or when it is deemed to be required to ensure compliance with Section 3.0 or where it is demonstrated through bacteriological testing that there is a need for disinfection, continuous disinfection shall be provided. The disinfection shall be chlorine, unless a substitute is approved prior to installation. Plans and specifications for the disinfection system shall be approved in accordance with subsection 1.11. When the disinfection is instituted, it shall be operated such that a free chlorine residual of at least 0.3 mg/L is maintained throughout the water distribution system. The supplier of water shall keep accurate records of the amount of chlorine used and shall have an approved test kit for measuring both free and total chlorine residuals. The supplier of water shall be required to conduct chlorine residual testing at least daily unless a lesser frequency is approved in writing by the Division, and shall report these results to the Division on a monthly basis in accordance with subsection 4.1.1. If a substitute disinfectant is approved, the operational and monitoring requirements shall be specified by the Division.

1.19.2 Public water systems must measure residual disinfectant concentrations with one of the analytical methods in the following table. Except for the method for ozone residuals, the disinfectant residual methods are contained in the 18th, 19th, and 20th editions of Standard Methods for the Examination of Water and Wastewater, 1992, 1995, and 1998 respectively; the cited methods published in any of these three editions may be used. The ozone method, 45400-O3 B, is contained in both the 18th and 19th editions of Standard Methods for the Examination of Water and Wastewater, 1992, 1995 respectively; either edition may be used. If approved by the Division, residual concentrations for free chlorine and combined chlorine also may be measured by using DPD colorimetric test kits. Free and total chlorine residuals may be measured continuously by adapting a specified chlorine residual method for use with a continuous monitoring instrument provided the chemistry, accuracy, and precision remain the same. Instruments used for continuous monitoring must be calibrated with a grab sample measurement at least every five days, or with a protocol approved by the Division.

1.19.3 Maximum Residual Disinfection Levels (MRDLs):

1.19.3.1 Maximum residual disinfection levels are as follows:

1.19.3.3 The Administrator, U.S. Environmental Protection Agency, pursuant to section 1412 of the Safe Drinking Water Act, hereby identifies the following as the best technology, treatment techniques, or other means available for achieving compliance with the maximum residual disinfectant levels identified in subsection 1.19.3.1: control of treatment processes to reduce disinfectant demand; and control of disinfection treatment processes to reduce disinfectant levels.

1.20 Compliance dates:

1.20.1 CWSs and NTNCWSs. Surface water or ground water under the direct influence of surface water systems serving 10,000 or more persons must comply with Section 21.0 beginning December 16, 2001. Surface water or ground water under the direct influence of surface water systems serving fewer than 10,000 persons and systems using only ground water not under the direct influence of surface water must comply with Section 20.0 beginning December 16, 2003.

1.20.2 Transient NCWSs. Surface water or ground water under the direct influence of surface water systems serving 10,000 or more persons and using chlorine dioxide as a disinfectant or oxidant must comply with the chlorine dioxide MRDL beginning December 16, 2001. Surface water or ground water under the direct influence of surface water systems serving fewer than 10,000 persons and using chlorine dioxide as a disinfectant or oxidant and systems using only ground water not under the direct influence of surface water and using chlorine dioxide as a disinfectant or oxidant must comply with the chlorine dioxide MRDL beginning December 16, 2003.

**History**
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *25 DE Reg. 713 (01/01/22)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *5 DE Reg. 2121 (05/01/02)*
- *9 DE Reg. 999 (12/01/05)*
- *15 DE Reg. 73 (07/01/12)*
- *17 DE Reg. 439 (10/01/13)*
- *19 DE Reg. 517 (12/01/15)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *25 DE Reg. 713 (01/01/22)*

##### **16 Del. Admin. Code § 4462-2.0** Definitions {#sec-4462-2.0 omnilex-key=us-de-regs-official--title-16--4462-2.0}

The following words and terms, when used in this regulation, have the following meaning unless the context clearly indicates otherwise:

"Action level" means the concentration of lead or copper in water specified in subsections 10.1.1.1 and 10.1.1.2 which determines, in some cases, the treatment requirements contained in Section 10.0 that a water system is required to complete.

“Air gap” means the unobstructed vertical distance through the free atmosphere between the lowest opening from any pipe or faucet supplying water to a tank, plumbing fixture, or other device and the flood-level rim of the receptacle.

"Alpha particle" means a particle identical with a helium nucleus, emitted from the nucleus of a radioactive element.

"Approved" means approved by the Division.

“Auxiliary water system” means a water supply system on, or available to, a water consumer’s premises that is maintained in addition to a public water supply system, including, but not limited to, a private water storage tank, water systems from ground or surface sources, or water from a public water system, which in any way has been treated, processed, or exposed to any possible contaminant or stored in other than an approved storage facility.

“Backflow” means the undesirable reversal of flow in a potable water distribution system as a result of a cross-connection.

“Bag filters” means pressure-driven separation devices that remove particulate matter larger than 1 (one) micrometer using an engineered porous filtration media. They are typically constructed of a non-rigid, fabric filtration media housed in a pressure vessel in which the direction of flow is from the inside of the bag to the outside.

“Bank filtration” means a water treatment process that uses a well to recover surface water that has naturally infiltrated into ground water through a river bed or bank(s). Infiltration is typically enhanced by the hydraulic gradient imposed by a nearby pumping water supply or other well(s).

"Best available technology" or “BAT” means the best technology, treatment techniques, or other means which the Division finds, after examination for efficacy under field conditions and not solely under laboratory conditions, are available (taking cost into consideration). For the purposes of setting maximum contaminant levels for synthetic organic chemicals, any BAT must be at least as effective as granular activated carbon.

"Beta particle" means a particle identical with an electron, emitted from the nucleus of a radioactive element.

“Capacity” means the overall capability of a water system to reliably produce and deliver water meeting all national primary drinking water regulations. Capacity encompasses the technical, managerial, and financial capabilities that will enable a water system to plan for, achieve, and maintain compliance with applicable drinking water standards.

“Cartridge filters” means pressure-driven separation devices that remove particulate matter larger than 1 (one) micrometer using an engineered porous filtration media. They are typically constructed as rigid or semi-rigid, self-supporting filter elements housed in pressure vessels in which flow is from the outside of the cartridge to the inside.

“Clean compliance history” means a record of no MCL violations under subsection 7.2; no monitoring violations under subsections 7.1 or 7.4; and no coliform treatment technique trigger exceedances or treatment technique violations under subsection 7.4.

"Coagulation" means a process using coagulant chemicals and mixing by which colloidal and suspended materials are de-stabilized and agglomerated into flocs.

"Coliform group" means all organisms considered in the coliform group as set forth in the current edition of Standard Methods for the Examination of Water and Waste Water prepared and published jointly by the American Public Health Association, American Water Works Association and Water Pollution Control Federation.

“Combined distribution system” means the interconnected distribution system consisting of the distribution systems of wholesale systems and of the consecutive systems that receive finished water.

"Compliance cycle" means the nine-year calendar year cycle during which public water systems must monitor. Each compliance cycle consists of three three-year compliance periods. The first calendar year cycle begins January 1, 1993 and ends December 31, 2001; the second begins January 1, 2002 and ends December 31, 2010, the third begins January 1, 2011 and ends December 31, 2019.

"Compliance period" means a three-year calendar year period within a compliance cycle. Each compliance cycle has three three-year compliance periods. Within the first compliance cycle, the first compliance period runs from January 1, 1993 to December 31, 1995; the second from January 1, 1996 to December 31, 1998, and the third from January 1, 1999 to December 31, 2001.

“Comprehensive performance evaluation” or “CPE” means a thorough review and analysis of a treatment plant's performance-based capabilities and associated administrative, operation and maintenance practices. It is conducted to identify factors that may be adversely impacting a plant's capability to achieve compliance and emphasizes approaches that can be implemented without significant capital improvements. The comprehensive performance evaluation must consist of at least the following components: assessment of plant performance; evaluation of major unit processes; identification and prioritization of performance limiting factors; assessment of the applicability of comprehensive technical assistance; and preparation of a CPE report.

"Confluent growth" means a continuous bacterial growth covering the entire filtration area of a membrane filter, or a portion thereof, in which bacterial colonies are not discrete.

"Consecutive water supply" means a public water system that receives some or all of its finished water from one or more wholesale systems. Delivery may be through a direct connection or through the distribution system of one or more consecutive systems. This part shall apply to each public water system, unless the public water system meets all of the following conditions: a) Consists only of distribution and storage facilities (and does not have any collection and treatment facilities); b) Obtains all of its water from, but is not owned or operated by, a public water system to which such regulations apply; c) Does not sell water to any person; and, d) Is not a carrier which conveys passengers in interstate commerce. The Division may opt to accept a consecutive supply as a single system for monitoring purposes.

“Containment” means a method where the installation of an approved air gap or backflow prevention assembly at the service connection to a water consumer’s premises is required to protect the public water system.

"Contaminant" means any physical, chemical, biological or radiological substance or matter in water.

"Conventional filtration treatment" means a series of processes including coagulation, flocculation, sedimentation and filtration resulting in substantial particulate removal.

"Corrosion inhibitor" means a substance capable of reducing the corrosivity of water toward metal plumbing materials, especially lead and copper, by forming a protective film on the interior surface of those materials.

“Cross-connection” means an actual or potential connection between any part of a potable water system and any other environment containing other substances in a manner that, under any circumstances, would allow for such substances to enter the potable water system.

“Cross-connection control program” means a program to eliminate, monitor, protect, and prevent cross-connections from allowing backflow.

"CT” or “CTcalc" means the product of the residual disinfectant concentration (C) in milligrams per liter (mg/L) determined before or at the first customer, and the corresponding disinfectant contact time (T) in minutes, i.e. "C" X "T". If a public water system applies disinfectants at more than one point prior to the first customer, it must determine the CT of each disinfectant sequence before or at the first customer to determine the total percent inactivation or total inactivation ratio. In determining the total inactivation ratio, the public water system must determine the residual disinfectant concentration of each disinfection sequence and corresponding contact time before any subsequent disinfection application point(s). CT99.9 is the CT value required for 99.9 percent (3-log) inactivation of Giardia lamblia cysts. The inactivation ratio is the CTcalc divided by the CT99.9 and the total inactivation ratio is the sum of the inactivation ratios for each disinfection sequence. A total inactivation ratio equal to or greater than 1.0 is assumed to provide a 3-log inactivation of Giardia lamblia cysts.

“Customer” means the owner or person in control of any premises supplied by or in any manner connected to a public water system.

"Diatomaceous earth filtration" means a process resulting in substantial particulate removal in which a precoat cake of diatomaceous earth filter media is deposited on a support membrane (septum), and while the water is filtered by passing through the cake on the septum, additional filter media known as body feed is continuously added to the feed water to maintain the permeability of the filter cake.

"Direct filtration" means a series of processes including coagulation and filtration but excluding sedimentation resulting in substantial particulate removal.

"Direct responsible charge" means accountability for and performance of active, daily, on-site operational duties.

"Disinfectant" means any oxidant, including but not limited to chlorine, chlorine dioxide, chloramines, and ozone added to water in any part of the treatment or distribution process, that is intended to kill or inactivate pathogens (disease causing organisms).

"Disinfectant contact time” or “T" means the time in minutes that it takes for water to move from the point of disinfectant application or the previous point of disinfectant residual measurement to a point before or at the point where residual disinfectant concentration (C) is measured. Where only one (1) "C" is measured, "T" is the time in minutes that it takes for water to move from the point of disinfectant application to a point before or at where residual disinfectant concentration (C) is measured. Where more than one (1) "C" is measured, "T" is for the first measurement of "C", the time in minutes that it takes for water to move from the first or only point of disinfectant application to a point before or at the point where the first "C" is measured and for subsequent measurements of "C", the time in minutes that it takes for water to move from the previous "C" measurement point to the "C" measurement point for which the particular "T" is being calculated. Disinfectant contact time in pipelines must be calculated based on plug flow by dividing the internal volume of the pipe by the maximum hourly flow rate through that pipe. Disinfectant contact time within mixing basins and storage reservoirs must be determined by tracer studies or an equivalent demonstration.

"Disinfection" means a process which inactivates pathogenic organisms in water by chemical oxidants or equivalent agents.

“Disinfection Profile” means a summary of daily Giardia lamblia inactivation through the treatment plant. The procedure for developing a disinfection profile is contained in subsection 10.8 and in 40 CFR subparts P and T (copies are available from the Office of Drinking Water).

"Division" means the Division of Public Health of the Department of Health and Social Services established by 29 Del.C. §7904(a).

"Domestic or other non-distribution system plumbing problem" means a coliform contamination problem in a public water system with more than one (1) service connection that is limited to the specific service connection from which the coliform positive sample was taken.

"Dose equivalent" means the product of the absorbed dose from ionizing radiation and such factors as account for differences and biological effectiveness due to the type of radiation and its distribution in the body as specified by the International Commission on Radiological Units and Measurements.

“Dual sample set” means a set of two samples collected at the same time and same location, with one sample analyzed for TTHM and the other analyzed for HAA5. Dual sample sets are collected for the purposes of conducting an Initial Distribution System Evaluation (IDSE) under Section 13.0 and determining compliance with the TTHM and HAA5 MCLs under subsection 9.2.1.2.

"Dwelling unit" means one or more rooms arranged for the use of one or more individuals as a single housekeeping unit with cooking, living, sanitary and sleeping facilities.

"Effective corrosion inhibitor residual" means a concentration sufficient to form a passivating film on the interior walls of a pipe.

"Emergency situation" means a condition in which the specific provisions of these regulations cannot be met for a temporary period and which necessitates immediate action because of the potential danger to public health.

“Enhanced coagulation” means the addition of sufficient coagulant for improved removal of disinfection byproduct precursors by conventional filtration treatment.

“Enhanced softening” means the improved removal of disinfection byproduct precursors by precipitative softening.

“Filter profile” means a graphical representation of individual filter performance, based on continuous turbidity measurements or total particle counts versus time for an entire filter run, from startup to backwash inclusively, that includes an assessment of filter performance while another filter is being backwashed.

"Filtration" means a process for removing particulate matter from water by passage through porous media.

“Finished water” means water that is introduced into the distribution system of a public water system and is intended for distribution and consumption without further treatment, except as treatment necessary to maintain water quality in the distribution system (e.g., booster disinfection, addition of corrosion control chemicals).

"First draw sample" means a one (1) liter sample of tap water, collected in accordance with subsection 10.7.2.2, that has been standing in plumbing pipes at least six (6) hours and is collected without flushing the tap.

"Flocculation" means a process to enhance agglomeration or collection of smaller floc particles into larger, more easily settleable particles through gentle stirring by hydraulic or mechanical means.

"Flood-level rim" means the edge of the receptacle from which water overflows.

“Flowing stream” means a course of running water flowing in a definite channel.

“GAC10” means granular activated carbon filter beds with an empty-bed contact time of 10 minutes based on average daily flow and a carbon reactivation frequency of every 180 days, except that the reactivation frequency for GAC10 used as a best available technology for compliance with MCLs under subsection 9.2.1.2 shall be 120 days.

“GAC20” means granular activated carbon filter beds with an empty-bed contact time of 20 minutes based on average daily flow and carbon reactivation frequency of every 240 days.

"Gross alpha particle activity" means the total radioactivity due to alpha particle emission as inferred from measurements on a dry sample.

"Gross beta particle activity" means the total radioactivity due to beta particle emission as inferred from measurements on a dry sample.

"Ground water under the direct influence of surface water" or “GUDI” means any water beneath the surface of the ground with significant occurrence of insects or other macroorganisms, algae, or large diameter pathogens such as Giardia lamblia or Cryptosporidium, or significant and relatively rapid shifts in water characteristics such as turbidity, temperature, conductivity, or pH which closely correlate to climatological or surface water conditions. Direct influence must be determined for individual sources in accordance with criteria established by the Division. The Division determination of direct influence may be based on site-specific measurements of water quality and/or documentation of well construction characteristics and geology with field evaluation.

“Haloacetic acids (five)” or “HAA5” mean the sum of the concentrations in milligrams per liter of the haloacetic acid compounds (monochloroacetic acid, dichloroacetic acid, trichloroacetic acid, monobromoacetic acid, and dibromoacetic acid), rounded to two significant figures after addition.

"Halogen" means one of the chemical elements chlorine, bromine or iodine.

“Health Advisory” or “HA” means an estimate of acceptable drinking water levels for a chemical substance based on health effects information; a Health Advisory is not a legally enforceable Federal standard, but serves as technical guidance to assist Federal, State and local officials.

“One-Day HA” means the concentration of a chemical in drinking water that is not expected to cause any adverse noncarcinogenic effects for up to one day of exposure. The One-Day HA is normally designed to protect a 10-kg child consuming one liter of water per day.

“Ten-Day HA” means the concentration of a chemical in drinking water that is not expected to cause any adverse noncarcinogenic effects for up to ten days of exposure. The Ten-Day HA is also normally designed to protect a 10-kg child consuming one liter of water per day.

“Lifetime HA” means the concentration of a chemical in drinking water that is not expected to cause any adverse noncarcinogenic effects for a lifetime of exposure. The Lifetime HA is based on exposure of a 70-kg adult consuming two liters of water per day. The Lifetime HA for Group C carcinogens includes an adjustment for possible carcinogenicity.

"Health hazard" means any condition, device or practice in the water supply system or its operation which creates, or may create, a danger to the health and well-being of the water consumer.

"Initial compliance period" means the first full three-year compliance period which begins at least 18 months after promulgation, except for the following contaminants: Dichloromethane; 1,2,4-Trichlorobenzene; 1,1,2-Trichloroethane; Benzo[a]pyrene; Dalapon; Di(2-ethylhexyl adipate; Di(2-ethylhexyl) phthalate; Dinoseb; Diquat; Endothall; Endrin; Glyphosate; Hexachlorobenzene; Hexachlorocyclopentadiene; Oxamyl (Vydate); Picloram; Simazine; 2,3,7,8-TCDD (Dioxin); Antimony; Beryllium; Cyanide; Nickel; and Thallium, initial compliance period means the first full three-year compliance period after promulgation for systems with 150 or more service connections (January 1993 -December 1995) and first full three-year compliance period after the effective date of regulation (January 1996 - December 1998) for systems having fewer than 150 service connections.

“Lake” or “reservoir” means a natural or manmade basin or hollow on the Earth’s surface in which water collects or is stored that may or may not have a current or single direction of flow.

"Large water system" means a water system that serves more than 50,000 persons.

"Lead service line" means a service line made of lead which connects the water main to the building inlet and any lead pigtail, gooseneck or other fitting which is connected to such lead line.

"Legionella" means a genus of bacteria, some species of which have caused a type of pneumonia called Legionnaires’ Disease.

“Level 1 assessment” means an evaluation to identify the possible presence of sanitary defects, defects in distribution system coliform monitoring practices, and (when possible) the likely reason that the system triggered the assessment. It is conducted by the system operator or owner. Minimum elements include review and identification of atypical events that could affect distributed water quality or indicate that distributed water quality was impaired; changes in distribution system maintenance and operation that could affect distributed water quality (including water storage); source and treatment considerations that bear on distributed water quality, where appropriate (e.g., whether a ground water system is disinfected); existing water quality data; and inadequacies in sample sites, sampling protocol, and sample processing. The system must conduct the assessment consistent with the Division directives that tailor specific assessment elements with respect to size and type of the system and the size, type, and characteristics of the distribution system.

“Level 2 assessment” means an evaluation to identify the possible presence of sanitary defects, defects in distribution system coliform monitoring practices, and (when possible) the likely reason that the system triggered the assessment. A Level 2 assessment provides a more detailed examination of the system (including the system’s monitoring and operational practices) than does a Level 1 assessment through the use of more comprehensive investigation and review of available information, additional internal and external resources, and other relevant practices. It is conducted by an individual approved by the Division, which may include the system operator. Minimum elements include review and identification of atypical events that could affect distributed water quality or indicate that distributed water quality was impaired; changes in distribution system maintenance and operation that could affect distributed water quality (including water storage); source and treatment considerations that bear on distributed water quality, where appropriate (e.g., whether a ground water system is disinfected); existing water quality monitoring data; and inadequacies in sample sites, sampling protocol, and sample processing. The system must conduct the assessment consistent with and Division directives that tailor specific assessment elements with respect to the size and type of system and the size, type, and characteristics of the distribution system. The system must comply with any expedited actions or additional actions required by the Division in the case of an E. coli MCL violation.

“Locational running annual average” or “LRAA” means the average of sample analytical results for samples taken at a particular monitoring location during the previous four calendar quarters.

"Man-made beta particle and photon emitters" means all radionuclides emitting beta particles and/or photons listed in Maximum Permissible Body Burdens and Maximum Permissible Concentrations of Radionuclides in Air or Water for Occupational Exposure, NBS Handbook 69, except the daughter products of thorium-232, uranium-235, and uranium-238.

"Maximum contaminant level” or “MCL" means the maximum permissible level of a contaminant in water which is delivered to any user of a public water system.

“Maximum residual disinfectant level” or “MRDL” means a level of a disinfectant added for water treatment that may not be exceeded at the consumer's tap without an unacceptable possibility of adverse health effects. For chlorine and chloramines, a PWS is in compliance with the MRDL when the running annual average of monthly averages of samples taken in the distribution system, computed quarterly, is less than or equal to the MRDL. For chlorine dioxide, a PWS is in compliance with the MRDL when daily samples are taken at the entrance to the distribution system and no two consecutive daily samples exceed the MRDL. MRDLs are enforceable in the same manner as maximum contaminant levels under section 1412 of the Safe Drinking Water Act. There is convincing evidence that addition of a disinfectant is necessary for control of waterborne microbial contaminants. Notwithstanding the MRDLs listed in 40 CFR section 141.65 (copies available from the Office of Drinking Water), operators may increase residual disinfectant levels of chlorine or chloramines (but not chlorine dioxide) in the distribution system to a level and for a time necessary to protect public health to address specific microbiological contamination problems caused by circumstances such as distribution line breaks, storm runoff events, source water contamination, or cross-connections.

“Maximum residual disinfection level goal” or “MRDLG” means the maximum level of a disinfectant added for water treatment at which no known or anticipated adverse effect on the health of persons would occur, and which allows an adequate margin of safety. MRDLGs are non-enforceable health goals and do not reflect the benefit of the addition of the chemical for control of waterborne microbial contaminants.

"Maximum total trihalomethane potential” or “MTP" means the maximum concentrations of total trihalomethanes produced in a given water containing a disinfectant residual after seven days at a temperature of 25° C or above.

“Membrane filtration” means a pressure or vacuum driven separation process in which particulate matter larger than 1 (one) micrometer is rejected by an engineered barrier, primarily through a size-exclusion mechanism, and which has a measurable removal efficiency of a target organism that can be verified through the application of a direct integrity test. This definition includes the common membrane technologies of microfiltration, ultrafiltration, nanofiltration, and reverse osmosis.

"Medium size water system" means a water system that serves greater than 3,300 and less than or equal to 50,000 persons.

"Minor monitoring violation" means the failure of a public water system to collect all required water samples or the failure to follow the prescribed sampling procedure within the prescribed time frame.

"Near the first service connection" means at one (1) of the twenty (20) percent of all service connections in the entire system that are nearest the water supply treatment facility, as measured by water transport time within the distribution system.

"Optimal corrosion control treatment" means the corrosion control treatment that minimizes the lead and copper concentrations at users' taps while ensuring that the treatment does not cause the water system to violate any national primary drinking water regulations.

"Person" means any corporation, company, association, firm, municipally owned water utility, partnership, society and joint stock company, as well as any individual.

"Picocurie” or “pCi" means the quantity of radioactive material producing 2.22 nuclear transformations per minute.

“Plant intake” means the works or structures at the head of a conduit through which water is diverted from a source (e.g., river or lake) into a treatment plant.

"Point of disinfectant application" means the point where the disinfectant is applied and water downstream of that point is not subject to recontamination by surface water runoff.

"Point of entry treatment device" means a treatment device applied to the drinking water entering a house or building for the purpose of reducing contaminants in the drinking water distributed throughout the house or building.

"Point of use treatment device" means a treatment device applied to a single tap used for the purpose of reducing contaminants in the drinking water at that one (1) tap.

"Pollution" means the presence of anything in water which tends to degrade its quality so as to constitute a health hazard or impair the usefulness of the water.

"Potable water" means water which is in compliance with all of the required drinking water standards specified in these regulations and is acceptable for human consumption.

“Premises” means real estate and the structures on it.

“Presedimentation” means a preliminary treatment process used to remove gravel, sand and other particulate material from the source water through settling before the water enters the primary clarification and filtration processes in a treatment plant.

"Primary maximum contaminant level” or “PMCL" means an MCL which involves a biological, chemical or physical characteristic of drinking water that may adversely affect the health of the consumer. This includes the MCLs for: coliform bacteria (includes total coliform and E. coli; antimony; arsenic; asbestos; barium; beryllium; cadmium; chromium; cyanide; fluoride; lead; mercury; nickel; nitrates; nitrites; total nitrate/nitrite selenium; thallium; turbidity; alachlor; atrazine; benzo(a)pyrene; carbofuran; chlordane; dalapon; di(2-ethylhexyl) adipate; di(2-ethylhexyl) phthalate; dibromochloropropane; dinoseb; diquat; 2,4-D; endothall; endrin; ethylenedibromide (EDB); glyphosate; heptachlor; heptachlor epoxide; hexachlorobenzene; hexachlorocyclopentadiene; lindane; methoxychlor; oxamyl (vydate); pentachlorophenol; picloram; polychlorinated biphenyls (PCBs); simazine; 2,3,7,8-TCDD (Dioxin); toxaphene; 2,4,5-TP silvex; total trihalomethanes; benzene; carbon tetrachloride; o-dichlorobenzene; p-dichlorobenzene; 1,2-dichloroethane, 1,1-dichloroetylene; cis-1,2-dichloroethylene; trans-1,2-dichloroethylene; dichloromethane; 1,2-dichlorpropane; ethylbenzene; monochlorobenzene; styrene; tetrachloroethylene; toluene; 1,2,4-trichlorobenzene; 1,1,1-trichloroethane; 1,1,2-trichloroethane; trichloroethylene; vinyl chloride; total xylenes and radioactivity (see Section 9.0).

"Protection by adequate construction, treatment and supervision" means:

Works which are of adequate capacity to meet the maximum demands without creating health hazards and which are located, designed and constructed to eliminate or prevent pollution.

Any one or any combination of the controlled processes of coagulation, sedimentation, absorption, filtration, disinfection or other processes appropriate to the sources of supply, which produces water consistently meeting the requirements of these regulations.

Conscientious operation of a public water supply by an individual in direct responsible charge who is acceptable to the Division, and meets the certification requirements of the Division.

“Public notice tiers” means that public notice requirements are divided into three tiers to take into account the seriousness of the violation or situation and any potential adverse health effects that may be involved.

Tier 1 public notice – required for National Primary Drinking Water (NPDWR) violations and situations with significant potential to have serious adverse effects on human health as a result of short-term exposure.

Tier 2 public notice – required for all other NPDWR violations and situations with potential to have serious adverse effects on human health.

Tier 3 public notice – required for all other NPDWR violations and situations not included in Tier 1 and Tier 2.

"Public water system” or “PWS" means a water supply system for the provision to the public of water for human consumption through pipes or other constructed conveyances either directly from the user's free flowing outlet or indirectly by the water being used to manufacture ice, foods and beverages or that supplies water for potable or domestic purposes for consumption in more than three dwelling units, or furnishes water for potable or domestic purposes to employees, tenants, members, guests or the public at large in commercial offices, industrial areas, multiple dwellings or semi-public buildings including, but without limitation, rooming and boarding houses, motels, tourist cabins, mobile home parks, restaurants, hospitals and other institutions, or offers any water for sale for potable domestic purposes. Public water systems are classified as follows:

"Community water system” or “CWS" means a public water system which serves at least fifteen (15) service connections used by year-round residents or regularly serves at least twenty-five (25) year-round residents;

"Miscellaneous public water system” or “MPWS" means a public water system that is neither community, transient non-community nor non-transient non-community.

"Non-transient non-community water system” or “NTNCWS" means a public water system that is not a community water system and that regularly serves at least twenty-five (25) of the same persons over six (6) months per year;

"Transient non-community water system” or “TNCWS" means a public water system which has at least fifteen (15) service connections or regularly serves an average of at least twenty-five (25) individuals daily at least sixty (60) days out of the year;

"Radioactivity" means the spontaneous, uncontrollable disintegration of the nucleus of an atom with the emission of particles and rays.

"Rem" means the unit of dose equivalent from ionizing radiation to the total body or any internal organ or organ system. A millirem is one one-thousandth (1/1000) of a rem.

"Repeat compliance period" means any subsequent compliance period after the initial compliance period.

"Residual disinfectant concentration” or “C" means the concentration of disinfectant measured in mg/L in a representative sample of water. Disinfectant levels of <0.04 mg/L shall be considered non-detectable.

“Sanitary defect” means a defect that could provide a pathway of entry for microbial contamination into the distribution system or that is indicative of a failure or imminent failure in a barrier that is already in place.

"Sanitary survey" means a review of the water source, facilities, equipment, operation and maintenance of a public water system for the purpose of: evaluating the adequacy of such source, facilities, equipment, operation and maintenance for producing and distributing potable drinking water; or updating the inventory information.

“Seasonal system” means a non-community water system that is not operated as a public water system on a year-round basis and starts up and shuts down at the beginning and end of each operating season.

"Secondary maximum contaminant level” or “SMCL" means an MCL which involves a biological, chemical or physical characteristic of water that may adversely affect the taste, odor, color or appearance (aesthetics), which may thereby affect public confidence or acceptance of the drinking water. This includes the MCLs for aluminum, chloride, color, copper, corrosivity, foaming agents, iron, manganese, odor, pH, silver, sulfate, total dissolved solids and zinc.

"Secretary, Delaware Health and Social Services" means the agency defined in 29 Del.C. §7933.

"Sedimentation" means a process for removal of solids before filtration by gravity or separation.

"Service connection" means a water line to a dwelling unit or building.

"Service line sample" means a one (1) liter sample of water collected in accordance with subsection 10.7.2.3 that has been standing for at least six (6) hours in a service line.

“Significant deficiency” means a defect in design, operation, or maintenance, or a failure or malfunction of the sources, treatment, storage, or distribution system that the Division determines to be causing, or has the potential for causing the introduction of contamination into the water delivered to consumers.

"Single family structure" means a building constructed as a single family residence that is currently used as either a residence or a place of business.

"Slow sand filtration" means a process involving passage of raw water through a bed of sand at low velocity (generally less than 0.4 meters per hour) resulting in substantial particulate removal by physical and biological mechanisms.

"Small water system" means a water system that served 3,300 persons or fewer.

"Source" means the place from which a system obtains its water. This may be either from underground or from the surface. Surface water may include rivers, lakes, reservoirs, springs, impoundments or a body of water with a surface exposed to the atmosphere.

"Standard sample" means the sample size for bacteriological testing and shall consist of:

For the fermentation tube test, five (5) standard portions of either twenty (20) milliliters (ml) or one hundred (100) ml.

For the membrane filter technique, not less than one hundred (100) ml.

“Subpart H systems” means public water systems using surface water or ground water under the direct influence of surface water as a source that are subject to the filtration and disinfection requirements of these regulations.

"Supplier of water" means any person who owns or operates a public water system.

"Surface water" means all water which is open to the atmosphere and subject to surface runoff.

“SUVA” means Specific Ultraviolet Absorption at 254 nanometers (nm), an indicator of the humic content of water. It is a calculated parameter obtained by dividing a sample's ultraviolet absorption at a wavelength of 254 nm (UV254) (in m-1) by its concentration of dissolved organic carbon (DOC) (in mg/L).

"System with a single service connection" means a system which supplies drinking water to consumers via a single service line.

"Too numerous to count" means that the total number of bacterial colonies exceeds two hundred (200) on a forty-seven (47) millimeter (mm) diameter membrane filter used for coliform detection.

"Total coliform-positive sample" means any Presence-Absence (P-A) Coliform Test with a result of present (P), any Minimal Medium ONPG-MUG (MMO-MUG) Test with a result of P, any Membrane Filter Technique test with a result of one (1) or more colonies per one hundred (100) ml, or any Multiple Tube Fermentation test with a result of one (1) or more positive tubes.

“Total organic carbon” or “TOC” means total organic carbon in mg/L measured using heat, oxygen, ultraviolet irradiation, chemical oxidants, or combinations of these oxidants that convert organic carbon to carbon dioxide, rounded to two significant figures.

"Total trihalomethanes” or “TTHMs" means the sum of the concentration in milligrams per liter of trihalomethane compounds [trichloromethane (chloroform), dibromochloromethane, bromodichloromethane and tribromomethane (bromoform)] rounded to two significant figures.

"Treatment technique requirement" means a requirement which specifies for a contaminant a specific treatment technique(s) demonstrated to the satisfaction of the Division to lead to a reduction in the level of such contamination sufficient to comply with these regulations.

"Trihalomethanes” or “THMs" means one of the family of organic compounds, named as derivatives of methane, wherein three (3) of the four (4) hydrogen atoms in methane are each substituted by a halogen atom in the molecular structure.

"Turbidity" means a measure of the clarity or cloudiness of water in Nephelometric Turbidity Units or NTUs.

“Two-stage lime softening” means a process in which chemical addition and hardness precipitation occur in each of two distinct unit clarification processes in series prior to filtration.

“Uncovered finished water storage facility” means a tank, reservoir, or other facility used to store water that will undergo no further treatment to reduce microbial pathogens except residual disinfection and is directly open to the atmosphere. Finished water storage facilities that are properly covered, screened and vented are excluded from this definition.

"Virus" means a virus of fecal origin which is infectious to humans by waterborne transmission.

"Vulnerable" means subject to contamination, a determination which shall be made by the Division based on previous monitoring results, the number of persons served by the public water system, the proximity of a smaller system to a larger system, the proximity to commercial or industrial use, disposal or storage of volatile synthetic organic compounds (VOCs), and the protection of the water source or sources.

"Waterborne disease outbreak" means the significant occurrence of an acute infectious illness, epidemiologically associated with the ingestion of water from a public water system which is deficient in treatment, as determined by the Division.

"Water distribution system" means any pumps, piping, or storage facilities from the source/treatment plant or, for consecutive water supplies, the interconnection to the wholesale system, to the property line of the ultimate consumer.

"Water supply system" means any structures, equipment, and appurtenances for collection, treatment, storage, or distribution of potable water from the source of supply or, for consecutive water supplies, the interconnection to the wholesale system, to the free-flowing outlet of the ultimate consumer.

“Wholesale system” means a public water system that treats source water as necessary to produce finished water and then delivers some or all of that finished water to another public water system. Delivery may be through the distribution system of one or more consecutive systems.

**History**
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *25 DE Reg. 713 (01/01/22)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *5 DE Reg. 2121 (05/01/02)*
- *9 DE Reg. 999 (12/01/05)*
- *15 DE Reg. 73 (07/01/12)*
- *17 DE Reg. 439 (10/01/13)*
- *19 DE Reg. 517 (12/01/15)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *25 DE Reg. 713 (01/01/22)*

##### **16 Del. Admin. Code § 4462-3.0** Source and Protection {#sec-4462-3.0 omnilex-key=us-de-regs-official--title-16--4462-3.0}

3.1 Water Source Desirability. Drinking water shall be obtained from the most desirable source which is feasible, and efforts must be made to prevent or control pollution of the source. If the source fails to meet the bacteriological standards of Section 7.0 and is not already disinfecting pursuant to subsection 1.19.1, it may be required to do so in order to meet the bacteriological standards.

3.2 Sanitary Surveys: Sanitary surveys shall be made by the Division in order to locate and identify health hazards which might exist in the water supply system. The manner and frequency of making these surveys, and the rate at which discovered health hazards are to be removed, shall be in accordance with a program approved by the Division.

3.2.1 Water systems must correct any major sanitary defects noted during a sanitary survey as soon as possible but no later than 120 days after being notified by the Division. If the corrections will take longer than 120 days to complete then a corrective action plan with a timetable must be submitted to the Office of Drinking Water.

3.2.2 Public water systems which do not collect five or more routine samples per month must undergo an initial sanitary survey by June 29, 1994, for community water systems and June 29, 1999, for non-community water systems. Thereafter, systems must undergo another sanitary survey every three years, except that non-community water systems using only protected ground water, as defined by the Division, must undergo subsequent sanitary surveys at least every five years after the initial sanitary survey. The Division must review the results of each sanitary survey to determine whether the existing monitoring frequency is adequate and what additional measures, if any, the system needs to undertake to improve drinking water quality.

3.2.3 In conducting a sanitary survey of a system using ground water in a State having an EPA-approved wellhead protection program under section 1428 of the Safe Drinking Water Act, information on sources of contamination within the delineated wellhead protection area that was collected in the course of developing and implementing the program should be considered instead of collecting new information, if the information was collected since the last time the system was subject to a sanitary survey.

3.2.4 Sanitary surveys must be performed by the Division or an agent approved by the Division. The system is responsible for ensuring the survey takes place.

3.2.5 Sanitary surveys conducted by the Division under provisions of subsection 8.2 may be used to meet the sanitary survey requirements of this section.

3.3 Protection of Water. Water delivered to every consumer by any public water supplier shall be so protected by natural means, by proper constructions or by treatment so as to consistently equal or exceed the requirements herein established.

3.4 Monitoring Water Quality. Quality of water delivered by any public water supplier shall be continuously and/or periodically monitored in accordance with requirements herein established or in accordance with such monitoring plan of equal or greater effect as may be proposed by a public water supplier for its own use, subject to Division approval.

3.5 Responsibility. For the purpose of application of these regulations, the supplier of water shall be responsible for the water quality at the user's free flowing outlet except for turbidity, inorganic compounds, radionuclides, SOCs, and VOCs, which are measured at a representative entry point(s) to the water distribution system.

3.6 Certified Operator. A water supply system shall be operated under the direct responsible charge of an individual whose qualifications meet the certification requirements of 16 DE Admin. Code 4463 Licensing and Registration of Operators of Public Water Supply Systems.

3.7 Approved Sampler/Tester:

3.7.1 An approved sampler/tester is approved for collecting water samples for laboratory analysis and on-site water quality testing. The approved sampler/tester is not a fully licensed operator and must work under the direction of a licensed operator. The approved sampler/tester must attend an approved course and pass a test approved by the Division. Individuals collecting samples under the tap water monitoring provisions of the lead/copper rule are exempted from this requirement.

3.7.2 Approved sampler/tester certification shall be valid for three years. An individual must attend a class approved by the Division and pass a test in order to receive certification. Attendance at an approved class and passing the test is required for renewal of the certification.

**History**
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *25 DE Reg. 713 (01/01/22)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *5 DE Reg. 2121 (05/01/02)*
- *9 DE Reg. 999 (12/01/05)*
- *15 DE Reg. 73 (07/01/12)*
- *17 DE Reg. 439 (10/01/13)*
- *19 DE Reg. 517 (12/01/15)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *25 DE Reg. 713 (01/01/22)*

##### **16 Del. Admin. Code § 4462-4.0** Reporting and Public Notification {#sec-4462-4.0 omnilex-key=us-de-regs-official--title-16--4462-4.0}

4.1 Reporting

4.1.1 Results of Test, Measurement or Analysis: Except where a shorter period is specified in this part, the supplier of water shall report to the Division on forms approved by the Division the results of any test, measurement or analysis required by this part within:

4.1.1.1 The first ten (10) days following the month in which the result is received; or

4.1.1.2 The first ten (10) days following the end of the required monitoring period as stipulated by the Division, whichever of these is shortest.

4.1.1.3 Daily testing for free available chlorine residual, nitrates, pH, fluoride or other chemicals as determined by the Division is required for systems that provide treatment (addition, removal or adjustment) unless another schedule is agreed to in writing by the Division.

4.1.2 Failure to comply with a PMCL: Unless otherwise stipulated, the supplier of water shall report to the Division within twenty-four (24) hours the failure to comply with any Primary Drinking Water Regulations (including failure to comply with monitoring requirements).

4.1.3 Analysis Performed by Division of Public Health Laboratory: The supplier of water is not required to report analytical results to the Division in cases where an approved laboratory performs the analyses and reports the results directly to the Division.

4.1.4 Reporting of Unregulated Contaminants: The owner of a CWS or NTNCWS who is required to monitor under 40 CFR 141.40, shall send a copy of the results of such monitoring to the Division within thirty (30) days of receipt and any public notice issued under subsection 4.2.6 to the Division.

4.1.5 Reporting by Surface Water Systems: A PWS that uses a surface water source or a ground water source under the direct influence of surface water and provides filtration treatment must report monthly to the Division the information specified in this paragraph, beginning June 29, 1993.

4.1.5.1 Turbidity measurements must be reported within ten (10) days after the end of each month the system serves water to the public. Information that must be reported includes:

4.1.5.1.1 The total number of filtered water turbidity measurements taken during the month.

4.1.5.1.2 The number and percentage of filtered water turbidity measurements taken during the month which are less than or equal to the turbidity limits for the filtration technology being used; and

4.1.5.1.3 The date and value of any turbidity measurements taken during the month which exceed one (1) NTU.

4.1.5.2 Each system, upon discovering that a waterborne disease outbreak potentially attributable to that water system has occurred, must report that occurrence to the Division as soon as possible, but no later than by the end of the next business day. If at any time the turbidity exceeds one (1) NTU, the system must inform the Division as soon as possible, but no later than the end of the next business day. If at any time the free available chlorine residual falls below 0.3 mg/L in the water entering the distribution system, the system must notify the Division as soon as possible, but no later than by the end of the next business day. The system must also notify the Division by the end of the next business day whether or not the free available chlorine residual was restored to at least 0.3 mg/L within four (4) hours.

4.1.6 Reporting of Chemical Overfeed Incidents or Unusual Events: It is the responsibility of the owner and/or the operator of a Public Water System to report to the Division, within 24 hours, any incidents of chemical overfeed and/or unusual events.

4.1.6.1 Examples of unusual events include but are not limited to the following:

4.1.7 Certification requirements: The public water system, within 10 days of completing the public notification requirements under subsection 4.2 of these regulations for the initial public notice and any repeat notices, must submit to the Division a certification that it has fully complied with the public notification requirements. The public water system must include with this certification a representative copy of each type of notice distributed, published, posted and made available to the persons served by the system and to the media.

4.1.8 Submission to the Division: The water supply system shall submit to the Division within the time stated in the request copies of any records required to be maintained under subsection 4.4 hereof or copies of any documents then in existence that the Division or the Administrator of the US Environmental Protection Agency is entitled to inspect pursuant to the authority of section 1445 of the Safe drinking Water Act or the equivalent provisions of the Delaware Code.

4.1.9 General Requirements

4.1.9.1 Each owner or operator of a public water system (community water systems, non-transient non-community water systems, and transient non-community water systems) must give notice for all violations of national primary drinking water regulations (NPDWR) and for other situations, as listed in subsection 4.1.9.1.1. The term ‘‘NPDWR violations’’ is used in this subsection to include violations of the maximum contaminant level (MCL), maximum residual disinfection level (MRDL), treatment technique (TT), monitoring requirements, and testing procedures. The table in subsection 4.2.3.1 identifies the tier assignment for each specific violation or situation requiring a public notice.

4.1.9.1.1 Violation categories and other situations requiring a public notice.

4.1.9.1.1.1 NPDWR violations:

4.1.9.1.1.1.1 Failure to comply with an applicable maximum contaminant level (MCL) or maximum residual disinfectant level (MRDL).

4.1.9.1.1.1.2 Failure to comply with a prescribed treatment technique (TT).

4.1.9.1.1.1.3 Failure to perform water quality monitoring, as required by the drinking water regulations.

4.1.9.1.1.1.4 Failure to comply with testing procedures as prescribed by a drinking water regulation.

4.1.9.1.1.2 Special public notices:

4.1.9.1.1.2.1 Occurrence of a waterborne disease outbreak or other waterborne emergency.

4.1.9.1.1.2.2 Exceedance of the nitrate MCL by non-community water systems (NCWS), where granted permission by the primacy agency under subsection 9.1.13.

4.1.9.1.1.2.3 Availability of unregulated contaminant monitoring data.

4.1.9.1.1.2.4 Other violations and situations determined by the primacy agency to require a public notice not already listed in subsection 4.2.3.

4.1.9.2 Public notice requirements are divided into three tiers, to take into account the seriousness of the violation or situation and of any potential adverse health effects that may be involved. The public notice requirements for each violation or situation listed in subsection 4.1.9.1.1 are determined by the tier to which it is assigned. Subsection 4.2.3 identifies the tier assignment for each specific violation or situation.

4.1.9.3 Each public water system must provide public notice to persons served by the water system, in accordance with this section.

4.1.9.3.1 Public water systems that sell or otherwise provide drinking water to other public water systems (i.e., to consecutive systems) are required to give public notice to the owner or operator of the consecutive system; the consecutive system is responsible for providing public notice to the persons it serves.

4.1.9.3.2 If a public water system has a violation in a portion of the distribution system that is physically or hydraulically isolated from other parts of the distribution system, the primacy agency may allow the system to limit distribution of the public notice to only persons served by that portion of the system which is out of compliance. Permission by the primacy agency for limiting distribution of the notice must be granted in writing.

4.1.9.3.3 A copy of the notice must also be sent to the primacy agency, in accordance with the requirements under subsection 4.2.1.1.4.

4.2 Public Notification

4.2.1 General Public Notice Requirements:

4.2.1.1 It shall be the duty and responsibility of a water supply owner to give public notice in accordance with the following requirements:

4.2.1.1.1 Tier 1 Public Notice: Form, manner, and frequency of notice.

4.2.1.1.1.1 Violation categories and other situations requiring a Tier 1 public notice. Subsection 4.2.3 identifies the tier assignment for each specific violation or situation.

4.2.1.1.1.1.1 Violation of the MCL for E. coli in the water distribution system (as specified in subsection 7.2), or when the water system fails to test for E. coli when any repeat sample tests positive for coliform (as specified in subsection 7.2);

4.2.1.1.1.1.2 Violation of the MCL for nitrate, nitrite, or total nitrate and nitrite, as defined in subsection 9.1, or when the water system fails to take a confirmation sample within 24 hours of the system's receipt of the first sample showing an exceedance of the nitrate or nitrite MCL, as specified in subsection 9.1.8.2 or violation of twice the MCL for fluoride as defined in subsection 9.1;

4.2.1.1.1.1.3 Exceedance of the nitrate MCL by non-community water systems, where permitted to exceed the MCL by the Division under subsection 9.1.13;

4.2.1.1.1.1.4 Violation of the MRDL for chlorine dioxide, as defined in subsection 12.3.1, when one or more samples taken in the distribution system the day following an exceedance of the MRDL at the entrance of the distribution system exceed the MRDL, or when the water system does not take the required samples in the distribution system, as specified in subsection 13.7;

4.2.1.1.1.1.5 Violation of the turbidity MCL under subsection 11.1.1, where the Division determines after consultation that a Tier 1 notice is required or where consultation does not take place within 24 hours after the system learns of the violation;

4.2.1.1.1.1.6 Violation of the Surface Water Treatment Rule (SWTR)(Section 17.0), Interim Enhanced Surface Water Treatment Rule (IESWTR) (Section 18.0) or the Long Term 1 Enhanced Surface Water Treatment Rule (LT1ESWTR) (Section 20.0) treatment technique requirement resulting from a single exceedance of the maximum allowable turbidity limit (as identified in subsection 4.2.3), where the Division determines after consultation that a Tier 1 notice is required or where consultation does not take place within 24 hours after the system learns of the violation;

4.2.1.1.1.1.7 Occurrence of a waterborne disease outbreak, as defined in Section 2.0, or other waterborne emergency (such as a failure or significant interruption in key water treatment processes, a natural disaster that disrupts the water supply or distribution system, or a chemical spill or unexpected loading of possible pathogens into the source water that significantly increases the potential for drinking water contamination);

4.2.1.1.1.1.8 Detection of E. coli, enterococci, or coliphage in source water samples as specified in subsections 8.3.1 and 8.3.2;

4.2.1.1.1.1.9 Other violations or situations with significant potential to have serious adverse effects on human health as a result of short-term exposure, as determined by the Division either in these regulations or on a case-by-case basis.

4.2.1.1.1.2 Public water systems must:

4.2.1.1.1.2.1 Provide a public notice as soon as practical but no later than 24 hours after the system learns of the violation;

4.2.1.1.1.2.2 Initiate consultation with the Division as soon as practical, but no later than 24 hours after the public water system learns of the violation or situation, to determine additional public notice requirements; and

4.2.1.1.1.2.3 Comply with any additional public notification requirements (including any repeat notices or direction on the duration of the posted notices) that are established as a result of the consultation with the Division. Such requirements may include the timing, form, manner, frequency, and content of repeat notices (if any) and other actions designed to reach all persons served.

4.2.1.1.1.3 Public water systems must provide the notice within 24 hours in a form and manner reasonably calculated to reach all persons served. The form and manner used by the public water system are to fit the specific situation, but must be designed to reach residential, transient, and non-transient users of the water system. In order to reach all persons served, water systems are to use, at a minimum, one or more of the following forms of delivery:

4.2.1.1.1.3.1 Appropriate broadcast media (such as radio and television);

4.2.1.1.1.3.2 Posting of the notice in conspicuous locations throughout the area served by the water system;

4.2.1.1.1.3.3 Hand delivery of the notice to persons served by the water system; or

4.2.1.1.1.3.4 Another delivery method approved in writing by the Division.

4.2.1.1.2 Tier 2 Public Notice: Form, manner and frequency of notice

4.2.1.1.2.1 Violation categories and other situations requiring a Tier 2 public notice. Subsection 4.2.3 identifies the tier assignment for each specific violation or situation.

4.2.1.1.2.1.1 All violations of the MCL, MRDL, Surface Water Treatment Rule (SWTR), Interim Enhanced Surface Water Treatment Rule (IESWTR), the Long Term 1 Enhanced Surface Water Treatment Rule (LT1ESWTR), the Long Term 2 ESWTR, Lead and Copper Rule (LCR), Disinfectant/Disinfection Byproduct Rules (DBPRs), and the Ground Water Rule (GWR) treatment technique requirements, except where a Tier 1 notice is required under subsection 4.1.1.1 or where the Division determines that a Tier 1 notice is required;

4.2.1.1.2.1.2 Violations of the monitoring and testing procedure requirements, where the Division determines that a Tier 2 rather than a Tier 3 public notice is required, taking into account potential health impacts and persistence of the violation;

4.2.1.1.2.1.3 Special notice for repeated failure to conduct monitoring of the source water for Cryptosporidium and for failure to determine bin classification or mean Cryptosporidium level.

4.2.1.1.2.1.3.1 The owner or operator of a community or non-community water system that is required to monitor source water under subsection 21.2 must notify persons served by the water system that monitoring has not been completed as specified no later than 14 days after the system has failed to collect any 3 months of monitoring as specified in subsection 21.2.3. The notice must be repeated as specified in subsection 4.2.1.1.2.2.1.

4.2.1.1.2.1.3.2 The owner or operator of a community or non-community water system that is required to determine a bin classification under subsection 21.11, or to determine mean Cryptosporidium level under subsection 21.13, must notify persons served by the water system that the determination has not been made as required no later than 14 days after the system has failed to report the determination as specified in subsection 21.11.5 or subsection 21.13.1, respectively. The notice must be repeated as specified in subsection 4.2.1.1.2.2.1. The notice is not required if the system is complying with a Division-approved schedule to address the violation.

4.2.1.1.2.1.3.3 The form and manner of the public notice must follow the requirements for a Tier 2 public notice prescribed in subsection 4.2.1.1.2. The public notice must be presented as required in subsection 4.2.2.3.1.

4.2.1.1.2.1.3.4 The notice must contain the following language, including the language necessary to fill in the blanks.

4.2.1.1.2.1.3.4.1 The special notice for repeated failure to conduct monitoring must contain the following language:

We are required to monitor the source of your drinking water for Cryptosporidium. Results of the monitoring are to be used to determine whether water treatment at the (treatment plant name) is sufficient to adequately remove Cryptosporidium from your drinking water. We are required to complete this monitoring and make this determination by (required bin determination date). We “did not monitor or test'' or “did not complete all monitoring or testing'' on schedule and, therefore, we may not be able to determine by the required date what treatment modifications, if any, must be made to ensure adequate Cryptosporidium removal. Missing this deadline may, in turn, jeopardize our ability to have the required treatment modifications, if any, completed by the deadline required, (date).

For more information, please call (name of water system contact) of (name of water system) at (phone number).

4.2.1.1.2.1.3.4.2 The special notice for failure to determine bin classification or mean Cryptosporidium level must contain the following language:

We are required to monitor the source of your drinking water for Cryptosporidium in order to determine by (date) whether water treatment at the (treatment plant name) is sufficient to adequately remove Cryptosporidium from your drinking water. We have not made this determination by the required date. Our failure to do this may jeopardize our ability to have the required treatment modifications, if any, completed by the required deadline of (date). For more information, please call (name of water system contact) of (name of water system) at (phone number).

4.2.1.1.2.1.3.4.3 Each special notice must also include a description of what the system is doing to correct the violation and when the system expects to return to compliance or resolve the situation.

4.2.1.1.2.1.4 Failure to take corrective action or failure to maintain at least 4-log treatment of viruses (using inactivation, removal, or a Division-approved combination of 4-log virus inactivation and removal) before or at the first customer under subsection 8.4.1.

4.2.1.1.2.1.5 Other violations or situations with significant potential to have adverse effects on human health as a result of exposure, as determined by the Division either in these regulations or on a case-by-case basis.

4.2.1.1.2.2 Public water systems must:

4.2.1.1.2.2.1 Public water systems must provide the public notice as soon as practical, but no later than 14 days after the system learns of the violation. If the public notice is posted, the notice must remain in place for as long as the violation or situation persists, but in no case for less than seven days, even if the violation or situation is resolved.

4.2.1.1.2.2.2 The public water system must repeat the notice every three months as long as the violation or situation persists, unless the Division determines that appropriate circumstances warrant a different repeat notice frequency. In no circumstance may the repeat notice be given less frequently than once per year. It is not appropriate for the Division to allow less frequent repeat notice for an MCL violation or treatment technique violation under the Total Coliform Rule or subsection 7.4 or a treatment technique violation under the Surface Water Rule or Interim Enhanced Surface Water Treatment rule. It is also not appropriate for the Division to allow through its rules or its policies across-the-board reductions in the repeat notice frequency for other ongoing violation requiring a Tier 2 repeat notice. Division determinations allowing repeat notices to be given less frequently than once every three months must be in writing.

4.2.1.1.2.2.3 For the turbidity violations specified in this paragraph, public water systems must consult with the Division as soon as practical but no later than 24 hours after the public water system learns of the violation, to determine whether a Tier 1 public notice under subsection 4.1.1.1 is required to protect public health. When consultation does not take place within the 24-hour period, the water system must distribute a Tier 1 notice of the violation within the next 24 hours (i.e., no later than 48 hours after the system learns of the violation), following the requirements under subsections 4.1.1.2 and 4.1.1.3. Consultation with the Division is required for:

4.2.1.1.2.2.3.1 Violation of the turbidity MCL under subsection 7.1.1; or

4.2.1.1.2.2.3.2 Violation of the SWTR, IESWTR or LT1ESWTR treatment technique requirement resulting from a single exceedance of the maximum allowable turbidity limit.

4.2.1.1.2.2.3.3 Public water systems must provide the initial public notice and any repeat notices in a form and manner that is reasonably calculated to reach persons served in the required time period. The form and manner of the public notice may vary based on the specific situation and type of water system, but it must at a minimum meet the following requirements:

4.2.1.1.2.2.3.3.1 Unless directed otherwise by the Division in writing, community water systems must provide notice by:

4.2.1.1.2.2.3.3.1.1 Mail or other direct delivery to each customer receiving a bill and to other service connections to which water is delivered by the public water system; and

4.2.1.1.2.2.3.3.1.2 Any other method reasonably calculated to reach other persons regularly served by the system, if they would not normally be reached by the notice required in subsection 4.2.1.3.1.1. Such persons may include those who do not pay water bills or do not have service connection addresses (e.g., house renters, apartment dwellers, university students, nursing home patients, prison inmates, etc.). Other methods may include: Publication in a local newspaper; delivery of multiple copies for distribution by customers that provide their drinking water to others (e.g., apartment building owners or large private employers); posting in public places served by the system or on the Internet; or delivery to community organizations.

4.2.1.1.2.2.3.3.2 Unless directed otherwise by the Division in writing, non-community water systems must provide notice by:

4.2.1.1.2.2.3.3.2.1 Posting the notice in conspicuous locations throughout the distribution system frequented by persons served by the system, or by mail or direct delivery to each customer and service connection (where known); and

4.2.1.1.2.2.3.3.2.2 Any other method reasonably calculated to reach other persons served by the system if they would not normally be reached by the notice required in subsection 4.2.1.1.3.2.1. Such persons may include those served who may not see a posted notice because the posted notice is not in a location they routinely pass by. Other methods may include: Publication in a local newspaper or newsletter distributed to customers; use of E-mail to notify employees or students; or, delivery of multiple copies in central locations (e.g., community centers).

4.2.1.1.3 Tier 3 Public Notice: Form, manner, and frequency of notice

4.2.1.1.3.1 Violation categories and other situations requiring a Tier 3 public notice. Subsection 4.2.3 identifies the tier assignment for each specific violation or situation.

4.2.1.1.3.1.1 Monitoring violations under 40 CFR part 141, except where a Tier 1 notice is required under subsection 4.2.1.1 or where the Division determines that a Tier 2 notice is required;

4.2.1.1.3.1.2 Failure to comply with a testing procedure established in 40 CFR part 141, except where a Tier 1 notice is required under subsection 4.2.1.1 or where the Division determines that a Tier 2 notice is required;

4.2.1.1.3.1.3 Failure to comply with subsection 3.6 of these regulations;

4.2.1.1.3.1.4 Availability of unregulated contaminant monitoring results, as required under subsection 4.2.6;

4.2.1.1.3.1.5 Other violations or situations with significant potential to have adverse effects on human health as a result of exposure, as determined by the Division either in these regulations or on a case-by-case basis; and

4.2.1.1.3.1.6 Reporting and recordkeeping violations under subsection 7.4.

4.2.1.1.3.2 Public water systems must:

4.2.1.1.3.2.1 Public water systems must provide the public notice not later than 90 days after the public water system learns of the violation or situation. Following the initial notice, the public water system must repeat the notice annually for as long as the violation or other situation persists. If the public notice is posted, the notice must remain in place for as long as the violation or other situation persists, but in no case less than seven days (even if the violation or situation is resolved).

4.2.1.1.3.3 Public water systems must provide the initial notice and any repeat notices in a form and manner that is reasonably calculated to reach persons served in the required time period. The form and manner of the public notice may vary based on the specific situation and type of water system, but it must at a minimum meet the following requirements:

4.2.1.1.3.3.1 Unless directed otherwise by the Division in writing, community water systems must provide notice by:

4.2.1.1.3.3.1.1 Mail or other direct delivery to each customer receiving a bill and to other service connections to which water is delivered by the public water system; and

4.2.1.1.3.3.1.2 Any other method reasonably calculated to reach other persons regularly served by the system, if they would not normally be reached by the notice required in subsection 4.2.1.1.3.1.1. Such persons may include those who do not pay water bills or do not have service connection addresses (e.g., house renters, apartment dwellers, university students, nursing home patients, prison inmates, etc.). Other methods may include: Publication in a local newspaper; delivery of multiple copies for distribution by customers that provide their drinking water to others (e.g., apartment building owners or large private employers); posting in public places or on the Internet; or delivery to community organizations.

4.2.1.1.3.3.2 Unless directed otherwise by the Division in writing, non-community water systems must provide notice by:

4.2.1.1.3.3.2.1 Posting the notice in conspicuous locations throughout the distribution system frequented by persons served by the system, or by mail or direct delivery to each customer and service connection (where known); and

4.2.1.1.3.3.2.2 Any other method reasonably calculated to reach other persons served by the system, if they would not normally be reached by the notice required in subsection 4.2.1.1.3.3.2.1. Such persons may include those who may not see a posted notice because the notice is not in a location they routinely pass by. Other methods may include: Publication in a local newspaper or newsletter distributed to customers; use of E-mail to notify employees or students; or, delivery of multiple copies in central locations (e.g., community centers).

4.2.1.1.4 Certification to the Division: The owner of a public water system, within ten (10) days of completing the public notice requirements of this section for the initial public notice and any repeat notices, shall submit to the Division a completed Delivery Certification Form, certifying when and how the public notice was delivered and that they have complied with the public notice regulations. The owner shall include with this certification a copy, as delivered, of each type of notice distributed, published, posted, and made available to the persons served by the system and to the media.

4.2.1.1.5 The Division may, at their discretion, also require a more stringent public notice tier (e.g., Tier 1 instead of Tier 2 or Tier 2 instead of Tier 3) for specific violations and situations.

4.2.2 Content of a Public Notice

4.2.2.1 When a public water system violates a NPDWR or has a situation requiring public notification, each public notice must include the following elements:

4.2.2.1.1 A description of the violation or situation, including the contaminant(s) of concern, and (as applicable) the contaminant level(s);

4.2.2.1.2 When the violation or situation occurred;

4.2.2.1.3 Any potential adverse health effects from the violation or situation, including the standard language under subsections 4.2.2.4.1 or 4.2.2.4.2, whichever is applicable;

4.2.2.1.4 The population at risk, including subpopulations particularly vulnerable if exposed to the contaminant in their drinking water;

4.2.2.1.5 Whether alternative water supplies should be used;

4.2.2.1.6 What actions consumers should take, including when they should seek medical help, if known;

4.2.2.1.7 What the system is doing to correct the violation or situation;

4.2.2.1.8 When the water system expects to return to compliance or resolve the situation;

4.2.2.1.9 The name, business address, and phone number of the water system owner, operator, or designee of the public water system as a source of additional information concerning the notice; and

4.2.2.1.10 A statement to encourage the notice recipient to distribute the public notice to other persons served, using the standard language under subsection 4.2.2.3.3, where applicable.

4.2.2.2 The public notice shall:

4.2.2.2.1 Each public notice required by this section:

4.2.2.2.1.1 Must be displayed in a conspicuous way when printed or posted;

4.2.2.2.1.2 Must not contain overly technical language or very small print;

4.2.2.2.1.3 Must not be formatted in a way that defeats the purpose of the notice;

4.2.2.2.1.4 Must not contain language which nullifies the purpose of the notice.

4.2.2.2.2 Each public notice required by this section must comply with multilingual requirements, as follows:

4.2.2.2.2.1 For public water systems serving a large proportion of non-English speaking consumers, as determined by the Division, the public notice must contain information in the appropriate language(s) regarding the importance of the notice or contain a telephone number or address where persons served may contact the water system to obtain a translated copy of the notice or to request assistance in the appropriate language.

4.2.2.2.2.2 In cases where the Division has not determined what constitutes a large proportion of non-English speaking consumers, the public water system must include in the public notice the same information as in subsection 4.2.2.2.2.1, where appropriate to reach a large proportion of non-English speaking persons served by the water system.

4.2.2.3 Public water systems are required to include the following standard language in their public notice:

4.2.2.3.1 Standard health effects language for MCL or MRDL violations, and treatment technique violations. Public water systems must include in each public notice the health effects language specified in subsection 4.2.2.5 corresponding to each MCL, MRDL, and treatment technique violation listed in subsection 4.2.2.

4.2.2.3.2 Standard language for monitoring and testing procedure violations. Public water systems must include the following language in their notice, including the language necessary to fill in the blanks, for all monitoring and testing procedure violations listed in subsection 4.2.2:

“We are required to monitor your drinking water for specific contaminants on a regular basis. Results of regular monitoring are an indicator of whether or not your drinking water meets health standards. During [compliance period], we “did not monitor or test” or “did not complete all monitoring or testing” for [contaminant(s)], and therefore cannot be sure of the quality of your drinking water during that time.”

4.2.2.3.3 Standard language to encourage the distribution of the public notice to all persons served. Public water systems must include in their notice the following language (where applicable):

“Please share this information with all the other people who drink this water, especially those who may not have received this notice directly (for example, people in apartments, nursing homes, schools, and businesses). You can do this by posting this notice in a public place or distributing copies by hand or mail.”

4.2.2.4 Mandatory Health Effects Language:

4.2.2.4.1 When providing the information on potential adverse health effects required by subsection 4.2.2.3.1 in notices of violations of MCLs or treatment technique requirements the owner of a PWS must include the following mandatory language specific to each contaminant:

4.2.2.4.1.1 Microbiological Contaminants:

Inadequately treated or inadequately protected water may contain disease-causing organisms. These organisms can cause symptoms such as diarrhea, nausea, cramps, and associated headaches.

Coliforms are bacteria that are naturally present in the environment and are used as an indicator that other, potentially-harmful, bacteria may be present or that a potential pathway exists through which contaminants may enter the drinking water distribution system. We found coliforms indicating the need to look for potential problems in water treatment or distribution. When this occurs we are required to conduct assessments to identify problems and to correct any problems that are found.

[THE SYSTEM MUST USE THE FOLLOWING APPLICABLE SENTENCES]

We failed to conduct the required assessment.

We failed to correct all identified sanitary defects that were found during the assessment(s).

E. coli are bacteria whose presence indicates that the water may be contaminated with human or animal wastes. Microbes in these wastes can cause short-term effects, such as diarrhea, cramps, nausea, headaches, or other symptoms. They may pose a special health risk for infants, young children, the elderly and people with severely compromised immune systems. We violated the standard for E. coli, indicating the need to look for potential problems in water treatment or distribution. When this occurs we are required to conduct a detailed assessment to identify problems and to correct any problems that are found.

[THE SYSTEM MUST USE THE FOLLOWING APPLICABLE SENTENCES]

We failed to conduct the required assessment.

We failed to correct all identified sanitary defects that were found during the assessment that we conducted,

Total organic carbon (TOC): Total organic carbon (TOC) has no health effects. However, total organic carbon provides a medium for the formation of disinfection byproducts. These byproducts include trihalomethanes (THMs) and haloacetic acids (HAAs). Drinking water containing these byproducts in excess of the MCL may lead to adverse health effects, liver or kidney problems, or nervous system effects, and may lead to an increased risk of getting cancer.

Turbidity: Turbidity has no health effects. However, turbidity can interfere with disinfection and provide a medium for microbial growth. Turbidity may indicate the presence of disease-causing organisms. These organisms include bacteria, viruses, and parasites that can cause symptoms such as nausea, cramps, diarrhea, and associated headaches.

Giardia lamblia, viruses, Heterotrophic plate count (HPC) bacteria, Legionella, and Cryptosporidium: Inadequately treated water may contain disease-causing organisms. These organisms include bacteria, viruses, and parasites which can cause symptoms such as nausea, cramps, diarrhea, and associated headaches. The language in this paragraph shall be used for any violation of the following rules: the Surface Water Treatment Rule; The Interim Enhanced Surface Water Treatment Rule; The Filter Backwash Recycling Rule; and, the Long Term 1 Enhanced Surface Water Treatment Rule.

4.2.2.4.1.2 Inorganic Contaminants:

4.2.2.4.1.3 Synthetic Organic Compounds

4.2.2.4.1.4 Volatile Organic Compounds:

4.2.2.4.1.5 Radiological Compounds

4.2.2.4.1.6 Disinfection/Disinfection Byproducts (DBPs), Byproduct Precursors, Disinfection Residuals: Where disinfection is used in the treatment of drinking water, disinfectants combine with organic and inorganic matter present in water to form chemicals called disinfection byproducts (DBPs). EPA sets standards for controlling the levels of disinfectants and DBPs in drinking water, including trihalomethanes (THMs) and haloacetic acids (HAAs).

4.2.2.4.1.7 Public Notification for Fluoride: Notice of violations of the MCL for fluoride shall consist of the public notice prescribed in this section, plus a description of any steps which the system is taking to come into compliance. The public notice must contain the following language:

Drinking water containing fluoride in excess of the MCL over many years may cause mottling of children’s teeth, usually in children less than nine years old. Mottling, also known as dental fluorosis, may include brown staining and/or pitting of the teeth, and occurs only in developing teeth before they erupt from the gums. Fluoride in drinking water at twice the MCL may cause bone disease, including pain and tenderness of the bones.

For more information, please call [name of water system contact] of [name of community water system] at [phone number]. Some home water treatment units are also available to remove fluoride from drinking water. To learn more about available home water treatment units, you may call NSF International at 1-877-8-NSF-HELP.

4.2.2.5 Public Notification by the State: The Division may give notice to the public required by this section on behalf of the owner of a public water system if the Division complies with the requirements of this section. However, the owner of the public water system remains legally responsible for ensuring that the requirements of this section are met.

4.2.2.6 Record Maintenance: Copies of public notices issued pursuant to subsection 4.2.2 of this part and certifications made to the Division pursuant to subsection 4.2.1.1.4 must be kept for five (5) years after issuance.

4.2.3 Frequency, Tier Designation and Distribution of Public Notification:

4.2.3.1 NPDWR Violations and Other Situations Requiring Public Notice1: Public notices shall be provided in accordance with the requirements of subsections 4.2.1, 4.2.2 and the following table:

Contaminant

MCL/MRDL/TT violations2

Monitoring and Testing Procedure violations

Tier of Public Notice Required

Citation

Tier of Public Notice Required

Citation

1. Violations of National Primary Drinking Water Regulations (NPDWR)3

A. Microbiological Contaminants

1.a. Total coliform bacteria †

2

7.0

3

7.0

1.b Total coliform (TT violations resulting from failure to perform assessments or corrective actions, monitoring violations, and reporting violations) ‡

2

7.4.10.2.1

3

7.4.10.3.1

1.c Seasonal system failure to follow Division-approved start-up plan prior to serving water to the public or failure to provide certification to the Division ‡

2

7.4.4.10.2.2

3

7.4.10.4.3

2.a Fecal coliform/E. coli †

1

7.0

41,3

7.0

2.b E. coli (MCL, monitoring, and reporting violations) ‡

1

7.4.10.1

3

7.4.10.3.2

7.4.10.4.1

7.4.10.4.2

2.c E. coli (TT violations resulting from failure to perform Level 2 Assessments or corrective action) ‡

2

7.4.10.2.1

3. Turbidity MCL

2

16.4

3

16.5

4. Turbidity MCL (average of 2 days samples >5 NTU)

52,1

16.4

3

16.5

5. Turbidity (for TT violations resulting from a single exceedance of maximum allowable turbidity level)

62,1

16.4

3

16.5

6. Surface Water Treatment rule violations, other than violations resulting from single exceedance of max. allowable turbidity level (TT)

2

16.0

3

16.0

7. Interim Enhanced Surface Water Treatment Rule violations, other than violations resulting from single exceedance of max. allowable turbidity level (TT)

72

17.0

3

17.0

8. Filter Backwash Recycling Rule violations.

2

18.0

3

18.0

9. Long Term 1 Enhanced Surface Water Treatment Rule violations]

2

19.0

3

19.0

10. Long Term 2 Enhanced Surface water Treatment Rule violations

2

20.0

222,3

20.2-20.6 and 20.9-20.10

11.Ground Water Rule Violations

2

8.0

3

8.4.2

B. Inorganic Chemicals (IOCs)

1. Antimony

2

9.1

3

9.1.2

2. Arsenic

2

89.1

3

119.1.2

3. Asbestos(fibers >10 microns)

2

9.1

3

9.1.2

4. Barium

2

9.1

3

9.1.2

5. Beryllium

2

9.1

3

9.1.2

6. Cadmium

2

9.1

3

9.1.2

7. Chromium (Total)

2

9.1

3

9.1.2

8. Cyanide

2

9.1

3

9.1.2

9. Fluoride

1,2

9.1

3

9.1.2

10. Mercury (inorganic)

2

9.1

3

9.1.2

11. Nickel

2

9.1

3

9.1.2

12. Nitrate

1

9.1

121,3

9.1.2

13. Nitrite

1

9.1

121,3

9.1.2

14. Total Nitrate and Nitrite

1

9.1

3

9.1.2

15. Selenium

2

9.1

3

9.1.2

16. Thallium

2

9.1

3

9.1.2

C. Lead and Copper Rule (Action level for lead is 0.015 mg/L, for copper is 1.3 mg/L)

1. Lead and Copper rule (TT)

2

10.0

3

10.0

D. Synthetic Organic Chemicals (SOCs)

1. 2,4 - D

2

9.2.1.1

3

9.2.2

2. 2,4,5 –TP

2

9.2.1.1

3

9.2.2

3. Alachlor

2

9.2.1.1

3

9.2.2

4. Atrazine

2

9.2.1.1

3

9.2.2

5. Benzo(a)pyrene (PAHs)

2

9.2.1.1

3

9.2.2

6. Carbofuran

2

9.2.1.1

3

9.2.2

7. Chlordane

2

9.2.1.1

3

9.2.2

8. Dalapon

2

9.2.1.1

3

9.2.2

9. Di (2-ethylhexyl) adipate

2

9.2.1.1

3

9.2.2

10. Di (2-ethylhexyl) phthalate

2

9.2.1.1

3

9.2.2

11. Dibromochloropropane

2

9.2.1.1

3

9.2.2

12. Dinoseb

2

9.2.1.1

3

9.2.2

13. Dioxin (2,3,7,8 – TCDD)

2

9.2.1.1

3

9.2.2

14. Diquat

2

9.2.1.1

3

9.2.2

15. Endothall

2

9.2.1.1

3

9.2.2

16. Endrin

2

9.2.1.1

3

9.2.2

17. Ethylene Dibromide

2

9.2.1.1

3

9.2.2

18. Glyphosate

2

9.2.1.1

3

9.2.2

19. Heptachlor

2

9.2.1.1

3

9.2.2

20. Heptachlor epoxide

2

9.2.1.1

3

9.2.2

21. Hexachlorobenzene

2

9.2.1.1

3

9.2.2

22. Hexachlorocyclopentadiene

2

9.2.1.1

3

9.2.2

23. Lindane

2

9.2.1.1

3

9.2.2

24. Methoxychlor

2

9.2.1.1

3

9.2.2

25. Oxamyl (Vydate)

2

9.2.1.1

3

9.2.2

26. Pentachlorophenol

2

9.2.1.1

3

9.2.2

27. Picloram

2

9.2.1.1

3

9.2.2

28. Polychlorinated biphenyls (PCBs)

2

9.2.1.1

3

9.2.2

29. Simazine

2

9.2.1.1

3

9.2.2

30. Toxaphene

2

9.2.1.1

3

9.2.2

E. Volatile Organic Chemicals (VOCs)

1. Benzene

2

9.2.1.3

3

9.2.2

2. Carbon tetrachloride

2

9.2.1.3

3

9.2.2

3. Chlorobenzene (monochlorobenzene)

2

9.2.1.3

3

9.2.2

4. o-Dichlorobenzene

2

9.2.1.3

3

9.2.2

5. p-Dichlorobenzene

2

9.2.1.3

3

9.2.2

6. 1,2-Dichloroethane

2

9.2.1.3

3

9.2.2

7. 1,1-Dichloroethylene

2

9.2.1.3

3

9.2.2

8. cis-1,2,-Dichloroethylene

2

9.2.1.3

3

9.2.2

9. trans-1,2-Dichloroethylene

2

9.2.1.3

3

9.2.2

10. Dichloromethane

2

9.2.1.3

3

9.2.2

11. 1,2-Dichloropropane

2

9.2.1.3

3

9.2.2

12. Ethylbenzene

2

9.2.1.3

3

9.2.2

13. Styrene

2

9.2.1.3

3

9.2.2

14. Tetrachloroethylene

2

9.2.1.3

3

9.2.2

15. Toluene

2

9.2.1.3

3

9.2.2

16. 1,2,4-Trichlorobenzene

2

9.2.1.3

3

9.2.2

17. 1,1,1-Trichloroethane

2

9.2.1.3

3

9.2.2

18. 1,1,2-Trichloroethane

2

9.2.1.3

3

9.2.2

19. Trichloroethylene

2

9.2.1.3

3

9.2.2

20. Vinyl chloride

2

9.2.1.3

3

9.2.2

21. Xylenes (total)

2

9.2.1.3

3

9.2.2

22. Methyl tert Butyl Ether

2

9.2.1.3

3

9.2.2

F. Radioactive Contaminants

1. Beta/photon emitters

2

16.1.1.4

3

16.2

2. Alpha emitters

2

16.1.1.3

3

16.2

3. Combined radium (226 & 228)

2

16.1.1.2

3

16.2

4. Uranium

92

16.1.1.5

103

16.2

G. Disinfection Byproducts (DBPs), Byproduct Precursors, Disinfection Residuals.13

1. Total trihalomethanes (TTHMs)

2

149.2.1.2, 9.2.2.1.11, 9.3.1.1, 9.3.1.2

3

12.6.1 to 12.6.5, 12.7.1 to 12.7.3, 13.0 to 13.6, 14.0 to 14.9

2. Haloacetic Acids (HAA5)

2

9.2.1.2, 9.2.2.1.11, 9.3.1.1, 9.3.1.2

3

12.6.1 to 12.6.5, 12.7.1 to 12.7.3, 13.0 to 13.6, 14.0 to 14.9

3. Bromate

2

9.2.1.2, 9.2.2.1.11

3

12.6.1 to 12.6.5, 12.7.1 to 12.7.3

4. Chlorite

2

9.2.1.2, 9.2.2.1.11

3

12.6.1 to 12.6.5, 12.7.1 to 12.7.3

5. Chlorine(MRDL)

2

1.19.3.1

3

12.6.1 to 12.6.5, 12.8.1

6. Chloramine (MRDL)

2

1.19.3.1

3

12.6.1 to 12.6.5, 12.8.1

7. Chlorine dioxide (MRDL), where any

two consecutive daily samples at

entrance to the distribution system only

are above MRDL

2

1.19.3.1, 12.14.2

215,3

12.6.1 to 12.6.5, 12.8.2, 12.14.2

8. Chlorine dioxide (MRDL), where

sample(s) in distribution system the

next day are also above MRDL

161

1.19.3.1, 12.14.2

1

12.6.1 to 12.6.5, 12.8.2, 12.14.2

9. Control of DBP precursors – TOC (TT)

2

12.16

3

12.6.1 to 12.6.5, 12.9

10. Bench marking and disinfection

profiling

N/A

N/A

3

17.5

11. Development of monitoring plan

N/A

N/A

3

12.11

H. Other Treatment Techniques

1. Acrylamide

2

9.3.3

N/A

N/A

2. Epichlorohydrin

2

9.3.3

N/A

N/A

II. Unregulated Contaminant Monitoring17

A. Unregulated contaminants

N/A

N/A

3

40 CFR 141.40

III. Other Situations Requiring Public Notice

A. Exceedance of nitrate MCL for

non-community systems, as allowed

by the Division

1

9.1.12

N/A

N/A

B. Availability of unregulated

contaminant monitoring data

3

40 CFR 141.40

N/A

N/A

C. Waterborne disease outbreak

1

2.0

N/A

N/A

D. Other waterborne emergency20

1

N/A

N/A

N/A

E. Other situations as determined by

the Division

211,2,3

N/A

N/A

N/A

F. Source water sample positive for

Ground Water Rule Fecal indicators:

E. coli, enterococci, or coliphage.

1

8.3

N/A

N/A

4.2.3.2 Notification to New Billing Units:

4.2.3.2.1 The owner of a community public water system must give a copy of the most recent public notice for any outstanding violation of any MCL, MRDL, or any treatment technique requirement, or monitoring violation to all new billing units or new hookups prior to or at the time service begins.

4.2.3.2.2 Non-community water systems must continuously post the public notice in conspicuous locations in order to inform new consumers of any continuing violation, variance or exemption, or other situation requiring a public notice for as long as the violation, variance, exemption, or other situation persists.

4.2.3.3 All posted public notices shall remain readable and be protected by glass, plastic or some other suitable covering and remain in place until such time that the violation or failure has terminated or seven (7) days, whichever is longer.

4.2.3.4 Notice to the public required by this section may be given by the Division should the water supplier fail to do so.

4.2.3.5 Nothing in this section shall limit the authority of the Secretary, Delaware Health and Social Services to require notification by newspaper and to radio and television stations when circumstances make more immediate or broader notice appropriate to protect the public's health.

4.2.4 Public Notification Requirements Pertaining to Lead

4.2.4.1 Applicability of Public Notification Requirements

4.2.4.1.1 Reserved

4.2.4.1.2 Definition of lead free. For the purposes of this paragraph, the term "lead free" when used with respect to solders and flux refers to solder and flux containing not more than 0.2 percent lead; when used with respect to pipes and pipe fittings, refers to pipes and pipe fittings containing not more than 8.0 percent lead; and when used with respect to plumbing fittings and fixtures intended by the manufacturer to dispense water for human ingestion refers to fittings and fixtures that are in compliance with standards established in accordance with 42 U.S.C. 300g-6(e).

4.2.4.1.3 The owner shall review, correct and complete the public notice and return it to the Division within seventy-two (72) hours with approval noted.

4.2.4.2 Manner of Notification

4.2.4.2.1 Notice shall be given to persons served by the PWS either by:

4.2.4.2.1.1 Three newspaper notices one ((1) for each of three (3) consecutive months and the first no later than June 19, 1988) or;

4.2.4.2.1.2 Once by mail notice with the water bill or in a separate mailing by June 19, 1988 or;

4.2.4.2.1.3 Once by hand delivery by June 19, 1988.

4.2.4.2.2 For NTNCWS, notice may be given by continuous posting. If posting is used, the notice shall be posted in a conspicuous place in the area served by the system and start no later than June 19, 1988, and continue for three (3) months.

4.2.4.3 General Content of Notice

4.2.4.3.1 Notices issued under this section shall provide a clear and readily understandable explanation of the potential sources of lead in drinking water, potential adverse health effects, reasonable available methods of mitigating known or potential lead content in drinking water, any steps the water system is taking to mitigate lead content in drinking water and the necessity for seeking alternative water supplies, if any. Use of the mandatory language in subsection 4.2.4.4 in the notice will be sufficient to explain potential adverse health effects.

4.2.4.3.2 Each notice shall also include specific advice on how to determine if materials containing lead have been used in homes or the water distribution system and how to minimize exposure to water likely to contain high levels of lead. Each notice shall be conspicuous and shall not contain unduly technical language, unduly small print, or similar problems that frustrate the purpose of the notice. Each notice shall contain the telephone number of the owner, operator or designee of the PWS as a source of additional information regarding the notice. Where appropriate, the notice shall be multi-lingual.

4.2.4.4 Mandatory Health Effects Information: When providing the information in public notices required under subsection 4.2.4.3 on the potential adverse health effects of lead in drinking water, the owner of the water system shall include the following mandatory language specific to lead.

4.2.4.4.1 Lead: The United States Environmental Protection Agency (USEPA) sets drinking water standards and has determined that lead is a health concern at certain levels of exposure. There is currently a standard of 0.020 parts per million (ppm). Part of the purpose of this notice is to inform you of the potential adverse health effects of lead. This is being done even though your water may not be in violation of the current standard. The USEPA and others are concerned about lead in drinking water. Too much lead in the human body can cause serious damage to the brain, kidneys, nervous system and red blood cells. The greatest risk, even with short-term exposure, is to young children and pregnant women. Lead levels in your drinking water are likely to be highest:

4.2.5 Public Notification Requirements Pertaining to VOCs and MRDLs: If a CWS or NTNCWS fails to comply with an applicable MCL or MRDL level established under subsections 9.1.1 and 12.3, the water supplier shall notify persons served by the system as provided in subsection 4.2.3.

4.2.6 Public Notification Requirements Pertaining to Unregulated Contaminants:

4.2.6.1 The owner of a community water system or non-transient, non-community water system required to monitor under 40 CFR 141.40 must notify persons served by the system of the availability of the results of such sampling no later than 90 days after the monitoring results are known.

4.2.6.2 The form and manner of the public notice must follow the requirements for a Tier 3 public notice prescribed in subsection 4.2.1.3.3. The notice must also identify a person and provide the telephone number to contact for information on the monitoring results.

4.2.7 Procedures for Issuance of a Public Notice

4.2.7.1 PMCL Violation:

4.2.7.1.1 Upon notification that a condition exists as indicated in subsection 4.2.1.1, the Division shall prepare a notice in accordance with subsection 4.2.2 and a draft public notice for use in public notification by the water supply owner.

4.2.7.1.2 As soon as possible, but in no case more than twenty-four (24) hours, the Division shall forward the notice and draft notice to the water supply owner.

4.2.7.1.3 The owner shall review, correct and complete the public notice and return it to the Division within twenty-four (24) hours with approval noted.

4.2.7.1.4 The Division shall resolve any discrepancies and approve the public notice as rapidly as possible and retain the public notice until the final confirmation sample results are received.

4.2.7.1.5 Upon receipt of the confirmation sampling results, the Division shall determine if a public notice is warranted and shall return the approved public notice to the owner for appropriate public notification.

4.2.7.1.6 For all Tier 1 violations as noted in subsection 4.2.1.1 the owner shall notify the Division as soon as possible. However, the owner shall be responsible for issuing the public notice to consumers within twenty-four (24) hours.

4.2.7.2 Other Violations or Circumstances Requiring Public Notification:

4.2.7.2.1 Upon notification that a condition exists as indicated in subsections 4.2.1.2. and 4.2.1.3, the Division shall initiate the preparation of a draft public notice and notice if appropriate.

4.2.7.2.2 As soon as possible, but in no case more than seventy-two (72) hours, the Division shall forward a copy of the draft public notice with attached notice, if applicable, to the water supply owner.

4.2.7.2.3 The owner shall review, correct and complete the public notice and return it to the Division within seventy-two (72) hours with approval noted.

4.2.7.2.4 The Division shall resolve any discrepancies and approve the public notice as rapidly as possible.

4.2.7.2.5 The Division shall then return the approved public notice to the owner for appropriate public notification.

**History**
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *25 DE Reg. 713 (01/01/22)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *5 DE Reg. 2121 (05/01/02)*
- *9 DE Reg. 999 (12/01/05)*
- *15 DE Reg. 73 (07/01/12)*
- *17 DE Reg. 439 (10/01/13)*
- *19 DE Reg. 517 (12/01/15)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *25 DE Reg. 713 (01/01/22)*

##### **16 Del. Admin. Code § 4462-5.0** Record Maintenance: {#sec-4462-5.0 omnilex-key=us-de-regs-official--title-16--4462-5.0}

5.1 Retaining Records:

5.1.1 Effective upon the adoption of these regulations, any owner or operator of a PWS shall accumulate and make available to the Division within the time stated the following records which shall be retained on the premises or at a convenient location:

5.1.1.1 Records of microbiological analyses and turbidity analyses made pursuant to these regulations shall be kept for not less than five (5) years.

5.1.1.2 Chemical analyses records for not less than ten (10) years.

5.1.1.3 Actual laboratory reports may be kept, or data may be transferred to tabular summaries, or scanned copies of results, provided that the following information is included:

5.1.1.3.1 The date, place and time of sampling and the name of the person who collected the sample;

5.1.1.3.2 Identification of the sample as to whether it was a routine distribution system sample, check sample, raw or process water sample or other special purpose sample;

5.1.1.3.3 Date of analysis;

5.1.1.3.4 Laboratory and person responsible for performing analysis;

5.1.1.3.5 The analytical technique/method used and;

5.1.1.3.6 The results of the analysis.

5.1.1.4 Records of action taken by the system to correct violations of PMCL regulations shall be kept for a period not less than three (3) years after the last action taken with respect to the particular violation involved.

5.1.1.5 Reports, summaries and communications relating to sanitary surveys shall be kept for a period not less than ten (10) years after completion of the sanitary survey of the system conducted by the system itself, by a private consultant or by any local, State or Federal agency.

5.1.1.6 Copies of monitoring plans developed pursuant to these regulations shall be kept for the same period of time as the records of analyses taken under the plan are required to be kept under subsection 5.1.1.1 except as specified elsewhere in these regulations.

5.1.1.7 Copies of Public Notices, Consumer Confidence Reports, the certifications for each, and any decisions by the Division relating to the Public Notice shall be kept for five (5) years.

5.1.1.8 Any decisions made pursuant to the provisions of Sections 14.0 and 15.0.

5.1.1.8.1 IDSE monitoring plans, plus any modifications required by the Division, must be kept until replaced by approved IDSE reports.

5.1.1.8.2 IDSE reports and 40/30 certifications, plus any modifications required by the Division, must be kept until replace or revised in their entirety.

5.1.1.8.3 Operational evaluations submitted by a system must be kept for 10 years following submission.

5.2 Records Kept by Division:

5.2.1 Records of microbiological analyses of repeat or special samples shall be retained for not less than one (1) year in the form of actual laboratory reports or in an appropriate summary form. Records of each of the following decisions made pursuant to the total coliform provisions shall be made in writing and retained by the Division.

5.2.1.1 Records of the following decisions must be retained for five (5) years:

5.2.1.1.1 Any decision to waive the twenty-four (24) hour time limit for collecting repeat samples after a total coliform positive routine sample if the public water system has a logistical problem in collecting the repeat sample that is beyond the system's control, and what alternative time limit the system must meet.

5.2.1.1.2 Any decision to allow a system to waive the requirement for five (5) routine samples the month following a total coliform-positive sample. If the waiver decision is made, the record of the decision must contain all items listed in that paragraph.

5.2.1.1.3 Any decision to invalidate a total coliform-positive sample. If the decision to invalidate a total coliform positive sample is made, the record of the decision must contain all the items in that paragraph.

5.2.1.2 Records of each of the following decisions must be retained in such a manner so that each system's current status may be determined:

5.2.1.2.1 Any decision to reduce the total coliform monitoring frequency for a CWS serving one thousand (1000) persons or fewer, that has no history of total coliform contamination in its current configuration and had a sanitary survey conducted within the last five (5) years showing that the system is supplied solely by a protected ground water source and is free of sanitary defects, to less than once per month and what the reduced monitoring frequency is. A copy of the reduced monitoring frequency must be provided to the system.

5.2.1.2.2 Any decision to reduce the total coliform monitoring frequency for a NCWS using only ground water and serving one thousand (1000) persons or fewer to less than once per quarter, and what the reduced monitoring frequency is. A copy of the reduced monitoring frequency must be provided to the system.

5.2.1.2.3 Any decision to reduce the total coliform monitoring frequency for a NCWS using only ground water and serving more than one thousand (1000) persons during any month the system serves one thousand (1000) persons or fewer. A copy of the reduced monitoring frequency must be provided to the system.

5.2.1.2.4 Any decision to waive the twenty-four hour limit for taking a total coliform sample for a PWS which uses surface water, or ground water under the influence of surface water, and which does not practice filtration, and which measures a source water turbidity level exceeding one (1) NTU near the first service connection.

5.2.1.2.5 Any decision that a NCWS is using only protected and disinfected ground water and therefore may reduce the frequency of its sanitary survey to less than once every five (5) years and what that frequency is. A copy of the reduced frequency must be provided to the system.

5.2.1.2.6 A list of agents other than the Division, if any, approved by the Division to conduct sanitary surveys.

5.2.1.2.7 Any decision to allow a PWS to forgo fecal coliform or E. coli testing on a total coliform positive sample if that system assumes that the total coliform positive sample is fecal coliform positive or E. coli positive.

**History**
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *25 DE Reg. 713 (01/01/22)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *5 DE Reg. 2121 (05/01/02)*
- *9 DE Reg. 999 (12/01/05)*
- *15 DE Reg. 73 (07/01/12)*
- *17 DE Reg. 439 (10/01/13)*
- *19 DE Reg. 517 (12/01/15)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *25 DE Reg. 713 (01/01/22)*

##### **16 Del. Admin. Code § 4462-6.0** Consumer Confidence Reports {#sec-4462-6.0 omnilex-key=us-de-regs-official--title-16--4462-6.0}

6.1 Purpose and applicability:

6.1.1 This section establishes the minimum requirements for the content of annual reports that community water systems must deliver to their customers. These reports must contain information on the quality of the water delivered by the systems and characterize the risks (if any) from exposure to contaminants detected in the drinking water in an accurate and understandable manner.

6.1.1.1 This section applies only to community water systems.

6.1.1.2 For purposes of this section, customers are defined as billing units or service connections to which water is delivered by a community water system.

6.1.1.3 For purposes of this section, detected means: at or above the levels prescribed by 40 CFR 141.23(a)(4) for inorganic contaminants, at or above the levels prescribed by 40 CFR 141.24(f)(7) for the contaminants listed in subsection 9.2.1.3, at or above the level prescribed by 40 CFR 141.24(h)(18) for the contaminants listed in subsection 9.2.1.1, and at or above the levels prescribed by 40 CFR 141.25(c) for radioactive contaminants.

6.2 Compliance dates:

6.2.1 Each existing community water system must deliver its report annually by July 1. Each report must contain data collected during, or prior to, the previous calendar year.

6.2.2 A new community water system must deliver its first report by July 1 of the year after its first full calendar year in operation and annually thereafter.

6.2.3 A community water system that sells water to another community water system must deliver the applicable information required in subsection 6.3.3 to the buyer system:

6.2.3.1 Annually by April 1; or

6.2.3.2 On a date mutually agreed upon by the seller and the purchaser and specifically included in a contract between the parties.

6.3 Content of the reports:

6.3.1 Each community water system must provide to its customers an annual report that contains the information specified in this section and subsection 6.3.4.

6.3.2 Information on the source of the water delivered:

6.3.2.1 Each report must identify the source(s) of the water delivered by the community water system by providing information on:

6.3.2.1.1 The type of the water: e.g., surface water, ground water; and

6.3.2.1.2 The commonly used name (if any) and location of the body (or bodies) of water.

6.3.2.2 If a source water assessment has been completed, the report must notify consumers of the availability of this information and the means to obtain it. In addition, systems are encouraged to highlight in the report significant sources of contamination in the source water area if they have readily available information. Where a system has received a source water assessment from the Division, the report must include a brief summary of the system's susceptibility to potential sources of contamination, using language provided by the Division or written by the operator.

6.3.3 Definitions:

6.3.3.1 Each report must include the following definitions:

6.3.3.1.1 “Maximum contaminant level goal” or “MCLG” means the level of a contaminant in drinking water below which there is no known or expected risk to health. MCLGs allow for a margin of safety.

6.3.3.1.2 “Maximum contaminant level” or “MCL” means the highest level of a contaminant that is allowed in drinking water. MCLs are set as close to the MCLGs as feasible using the best available treatment technology.

6.3.3.2 A report for a community water system operating under a variance or exemption issued under sections 1415 or 1416 of the Safe Drinking Water Act must include the following definition: “Variances and exemptions” means Division or EPA permission not to meet an MCL or a treatment technique under certain conditions.

6.3.3.3 A report which contains data on a contaminant for which the Division has set a treatment technique or an action level must include one or both of the following definitions as applicable:

6.3.3.3.1 “Treatment technique” means a required process intended to reduce the level of a contaminant in drinking water.

6.3.3.3.2 “Action level” means the concentration of a contaminant which, if exceeded, triggers treatment or other requirements which a water system must follow.

6.3.3.3.3 “Maximum residual disinfectant level goal” or “MRDLG” means the level of a drinking water disinfectant below which there is no known or expected risk to health. MRDLGs do not reflect the benefits of the use of disinfectants to control microbial contaminants.

6.3.3.3.4 “Maximum residual disinfectant level” or “MRDL” means the highest level of a disinfectant allowed in drinking water. There is convincing evidence that addition of a disinfectant is necessary for control microbial contaminants.

6.3.3.4 A report that contains information regarding a Level 1 or Level 2 Assessment required under subsection 7.4 must include the applicable definitions:

6.3.3.4.1 “Level 1 assessment” means a study of the water system to identify potential problems and determine (if possible) why total coliform bacteria have been found in our water system.

6.3.3.4.2 “Level 2 assessment” means a very detailed study of the water system to identify potential problems and determine (if possible) why an E. coli MCL violation has occurred and/or why total coliform bacteria have been found in our water system on multiple occasions.

6.3.4 Information on Detected Contaminants:

6.3.4.1 This subsection specifies the requirements for information to be included in each report for contaminants subject to mandatory monitoring (except Cryptosporidium). It applies to:

6.3.4.1.1 Contaminants subject to an MCL, MRDL, action level, or treatment technique (regulated contaminants);

6.3.4.1.2 Contaminants for which monitoring is required by 40 CFR 141.40 (unregulated contaminants);

6.3.4.1.3 Unregulated contaminants for which the US EPA has developed and published a health advisory; and

6.3.4.2 The data relating to these contaminants must be displayed in one table or in several adjacent tables. Any additional monitoring results which a community water system chooses to include in its report must be displayed separately.

6.3.4.3 The data must be derived from data collected during the applicable calendar year to comply with EPA and State monitoring and analytical requirements except that:

6.3.4.3.1 Where a system is allowed to monitor for regulated contaminants less often than once a year, the table(s) must include the date and results of the most recent sampling and the report must include a brief statement indicating that the data presented in the report are from the most recent testing done in accordance with the regulations. No data older than 5 years need be included.

6.3.4.4 For detected regulated contaminants (listed in subsection 6.6), the table(s) must contain:

6.3.4.4.1 The MCL for that contaminant expressed as a number equal to or greater than 1.0 (as provided in subsection 6.6);

6.3.4.4.2 The MCLG for that contaminant expressed in the same units as the MCL;

6.3.4.4.3 If there is no MCL for a detected contaminant, the table must indicate that there is a treatment technique, or specify the action level, applicable to that contaminant, and the report must include the definitions for treatment technique and/or action level, as appropriate, specified in subsection 6.3.3;

6.3.4.4.4 For contaminants subject to an MCL, except turbidity and total coliforms, the highest contaminant level used to determine compliance with an NPDWR and the range of detected levels, as follows:

6.3.4.4.4.1 When compliance with the MCL is determined annually or less frequently: The highest detected level at any sampling point and the range of detected levels expressed in the same units as the MCL.

6.3.4.4.4.2 When compliance with the MCL is determined by calculating a running annual average of all samples taken at a monitoring location: the highest average of any of the monitoring locations and the range of all monitoring locations expressed in the same units as the MCL. For the MCLs for TTHM and HAA5 in subsection 9.2.1.2, systems must include the highest locational running annual average for TTHM and HAA5 and the range of individual sample results for all monitoring locations expressed in the same units as the MCL. If more than one location exceeds TTHM or HAA5 MCL, the system must include the locational running annual average for all locations that exceed the MCL.

6.3.4.4.4.3 When compliance with the MCL is determined on a system-wide basis by calculating a running annual average of all samples at all monitoring locations: the average and range of detection expressed in the same units as the MCL. The system is required to include individual sample results for the IDSE conducted under Section 13.0 when determining the range of the TTHM and HAA5 results to be reported in the annual consumer confidence report for the calendar year that the IDSE samples were taken.

Note to subsection 6.3.4.4.4: When rounding of results to determine compliance with the MCL is allowed by the regulations, rounding should be done prior to multiplying the results by the factor listed in subsection 6.6;

6.3.4.4.5 For turbidity.

6.3.4.4.5.1 When it is reported pursuant to subsection 16.4: The highest average monthly value.

6.3.4.4.5.2 When it is reported pursuant to the requirements of 40 CFR 141.71: the highest monthly value. The report should include an explanation of the reasons for measuring turbidity.

6.3.4.4.5.3 When it is reported pursuant to subsections 16.4, 17.0 or 16.4.4: The highest single measurement and the lowest monthly percentage of samples meeting the turbidity limits specified in subsections 16.4, 17.0 or 16.4.4 for the filtration technology being used. The report should include an explanation of the reasons for measuring turbidity;

6.3.4.4.6 For lead and copper: the 90th percentile value of the most recent round of sampling and the number of sampling sites exceeding the action level;

6.3.4.4.7 For E. coli: total number of positive samples; and

6.3.4.4.8 The likely source(s) of detected contaminants to the best of the operator's knowledge. Specific information regarding contaminants may be available in sanitary surveys and source water assessments, and should be used when available to the operator. If the operator lacks specific information on the likely source, the report must include one or more of the typical sources for that contaminant listed in subsection 6.6 that is most applicable to the system.

6.3.4.4.9 For E. coli analytical results under subsection 7.4: The total number of positive samples.

6.3.4.5 If a community water system distributes water to its customers from multiple hydraulically independent distribution systems that are fed by different raw water sources, the table should contain a separate column for each service area and the report should identify each separate distribution system. Alternatively, systems could produce separate reports tailored to include data for each service area.

6.3.4.6 The table(s) must clearly identify any data indicating violations of MCLs, MRDLs or treatment techniques and the report must contain a clear and readily understandable explanation of the violation including: the length of the violation, the potential adverse health effects, and actions taken by the system to address the violation. To describe the potential health effects, the system must use the relevant language of subsection 6.6.

6.3.4.7 For detected unregulated contaminants for which monitoring is required (except Cryptosporidium), the table(s) must contain the average and range at which the contaminant was detected. The report may include a brief explanation of the reasons for monitoring for unregulated contaminants.

6.3.5 Information on Cryptosporidium, radon, and other contaminants:

6.3.5.1 If the system has performed any monitoring for Cryptosporidium, including monitoring performed to satisfy the requirements of 40 CFR 141.143, which indicates that Cryptosporidium may be present in the source water or the finished water, the report must include:

6.3.5.1.1 A summary of the results of the monitoring; and

6.3.5.1.2 An explanation of the significance of the results.

6.3.5.2 If the system has performed any monitoring for radon which indicates that radon may be present in the finished water, the report must include:

6.3.5.2.1 The results of the monitoring; and

6.3.5.2.2 An explanation of the significance of the results.

6.3.5.3 If the system has performed additional monitoring which indicates the presence of other contaminants in the finished water, EPA strongly encourages systems to report any results which may indicate a health concern. To determine if results may indicate a health concern, EPA recommends that systems find out if EPA has proposed an NPDWR or issued a health advisory for that contaminant by calling the Safe Drinking Water Hotline (800-426-4791). EPA considers detects above a proposed MCL or health advisory level to indicate possible health concerns. For such contaminants, EPA recommends that the report include:

6.3.5.3.1 The results of the monitoring; and

6.3.5.3.2 An explanation of the significance of the results noting the existence of a health advisory or a proposed regulation.

6.3.6 Compliance with NPDWR. In addition to the requirements of subsection 6.3.4.6, the report must note any violation that occurred during the year covered by the report of a requirement listed below, and include a clear and readily understandable explanation of the violation, any potential adverse health effects, and the steps the system has taken to correct the violation.

6.3.6.1 Monitoring and reporting of compliance data;

6.3.6.2 Filtration and disinfection prescribed by Section 16.0. For systems which have failed to install adequate filtration or disinfection equipment or processes, or have had a failure of such equipment or processes which constitutes a violation, the report must include the following language as part of the explanation of potential adverse health effects: Inadequately treated water may contain disease-causing organisms. These organisms include bacteria, viruses, and parasites which can cause symptoms such as nausea, cramps, diarrhea, and associated headaches.

6.3.6.3 Lead and copper control requirements prescribed by Section 10.0. For systems which fail to take one or more actions prescribed by subsections 10.1.2, 10.2, 10.3, 10.4, and 10.5, the report must include the applicable language of 6.6 for lead, copper, or both.

6.3.6.4 Treatment techniques for Acrylamide and Epichlorohydrin prescribed by subsection 9.3.3. For systems which violate the requirements of subsection 9.3.3, the report must include the relevant language from 6.6.

6.3.6.5 Recordkeeping of compliance data.

6.3.6.6 Special monitoring requirements prescribed by 40 CFR sections 141.40 and 141.41; and

6.3.6.7 Violation of the terms of a bilateral compliance agreement, or an administrative or judicial order.

6.3.6.7.1 A brief status report on the steps the system is taking to install treatment, find alternative sources of water, or otherwise comply with the terms and schedules of the bilateral compliance agreement, administrative or judicial order.

6.3.7 Additional information:

6.3.7.1 The report must contain a brief explanation regarding contaminants which may reasonably be expected to be found in drinking water including bottled water. This explanation may include the language of subsections 6.3.7.1.1 through 6.3.7.1.3 or systems may use their own comparable language. The report also must include the language of subsection 6.3.8.1.4.

6.3.7.1.1 The sources of drinking water (both tap water and bottled water) include rivers, lakes, streams, ponds, reservoirs, springs, and wells. As water travels over the surface of the land or through the ground, it dissolves naturally-occurring minerals and, in some cases, radioactive material, and can pick up substances resulting from the presence of animals or from human activity.

6.3.7.1.2 Contaminants that may be present in source water include:

6.3.7.1.2.1 Microbial contaminants, such as viruses and bacteria, which may come from sewage treatment plants, septic systems, agricultural livestock operations, and wildlife.

6.3.7.1.2.2 Inorganic contaminants, such as salts and metals, which can be naturally-occurring or result from urban stormwater runoff, industrial or domestic wastewater discharges, oil and gas production, mining, or farming.

6.3.7.1.2.3 Pesticides and herbicides, which may come from a variety of sources such as agriculture, urban stormwater runoff, and residential uses.

6.3.7.1.2.4 Organic chemical contaminants, including synthetic and volatile organic chemicals, which are by-products of industrial processes and petroleum production, and can also come from gas stations, urban stormwater runoff, and septic systems.

6.3.7.1.2.5 Radioactive contaminants, which can be naturally-occurring or be the result of oil and gas production and mining activities.

6.3.7.1.3 In order to ensure that tap water is safe to drink, EPA prescribes regulations which limit the amount of certain contaminants in water provided by public water systems. FDA regulations establish limits for contaminants in bottled water which must provide the same protection for public health.

6.3.7.1.4 Drinking water, including bottled water, may reasonably be expected to contain at least small amounts of some contaminants. The presence of contaminants does not necessarily indicate that water poses a health risk. More information about contaminants and potential health effects can be obtained by calling the Environmental Protection Agency's Safe Drinking Water Hotline (800-426-4791).

6.3.7.2 The report must include the telephone number of the owner, operator, or designee of the community water system as a source of additional information concerning the report.

6.3.7.3 In communities with a large proportion of non-English speaking residents, as determined by the Division, the report must contain information in the appropriate language(s) regarding the importance of the report or contain a telephone number or address where such residents may contact the system to obtain a translated copy of the report or assistance in the appropriate language.

6.3.7.4 The report must include information (e.g., time and place of regularly scheduled board meetings) about opportunities for public participation in decisions that may affect the quality of the water.

6.3.7.5 The systems may include such additional information as they deem necessary for public education consistent with, and not detracting from, the purpose of the report.

6.3.7.6 Systems required to comply with Section 8.0 Ground Water Rule.

6.3.7.6.1 Any ground water system that receives notice from the Division of a significant deficiency or notice from a laboratory of a fecal indicator-positive ground water source sample that is not invalidated by the Division under subsection 8.3.4 must inform its customers of any significant deficiency that is uncorrected at the time of the next report or of any fecal indicator-positive ground water source sample in the next report. The system must continue to inform the public annually until the Division determines that particular significant deficiency is corrected or the fecal contamination in the ground water source is addressed under subsection 8.4.1. Each report must include the following elements.

6.3.7.6.1.1 The nature of the particular significant deficiency or the source of the fecal contamination (if the source is known) and the date the significant deficiency was identified by the Division or the dates of the fecal indicator-positive ground water source samples;

6.3.7.6.1.2 If the fecal contamination in the ground water source has been addressed under subsection 8.4.1 and the date of such action;

6.3.7.6.1.3 For each significant deficiency or fecal contamination in the ground water source that has not been addressed under subsection 8.4.1, the Division-approved plan and schedule for correction, including interim measures, progress to date, and any interim measures completed; and

6.3.7.6.1.4 If the system receives notice of a fecal indicator-positive ground water source sample that is not invalidated by the division under subsection 8.3.4, the potential health effects using the health effects language of subsection 6.6.

6.3.7.6.2 If directed by the Division, a system with significant deficiencies that have been corrected before the next report is issued must inform its customers of the significant deficiency, how the deficiency was corrected, and the date of the correction under subsection 6.3.7.6.1.

6.3.7.7 Systems required to comply with subsection 7.4 Revised Total Coliform Rule

6.3.7.7.1 Any system required to comply with the Level 1 assessment requirement or the Level 2 assessment requirement that is not due to an E. coli MCL violation must include in the report the text found subsection 6.3.7.7.1.1 and subsections 6.3.7.7.1.2 and 6.3.7.7.1.3 as appropriate, filling in the blanks accordingly and the text found in subsections 6.3.7.7.1.4.1 and 6.3.7.7.1.4.2 if appropriate.

6.3.7.7.1.1 Coliforms are bacteria that are naturally present in the environment and are used as an indicator that other, potentially harmful, waterborne pathogens may be present or that a potential pathway exists through which contamination may enter the drinking water distribution system. We found coliforms indicating the need to look for potential problems in water treatment or distribution. When this occurs, we are required to conduct assessment(s) to identify problems and to correct any problems that were found during these assessments.

6.3.7.7.1.2 During the past year we were required to conduct [INSERT NUMBER OF LEVEL 1 ASSESSMENTS] Level 1 assessment(s). [INSERT NUMBER OF LEVEL 1 ASSESSMENTS] Level 1 assessment(s) were completed. In addition, we were required to take [INSERT NUMBER OF CORRECTIVE ACTIONS] corrective actions and we completed [INSERT NUMBER OF CORRECTIVE ACTIONS] of these actions.

6.3.7.7.1.3 During the past year [INSERT NUMBER OF LEVEL 2 ASSESSMENTS] Level 2 assessments were required to be completed for our water system. [INSERT NUMBER OF LEVEL 2 ASSESSMENTS] Level 2 assessment(s) were completed. In addition, we were required to take [INSERT NUMBER OF CORRECTIVE ACTIONS] corrective actions and we completed [INSERT NUMBER OF CORRECTIVE ACTIONS] of these actions.

6.3.7.7.1.4 Any system that has failed to complete all of the required assessments or correct all identified sanitary defects, is in violation of the treatment technique requirement and must also include one or both of the following statements, as appropriate:

6.3.7.7.1.4.1 During the past year we failed to conduct all of the required assessment(s).

6.3.7.7.1.4.2 During the past year we failed to correct all identified defects that were found during the assessment.

6.3.7.7.2 Any system required to conduct a Level 2 assessment due to an E. coli MCL violation must include in the report the text found in subsections 6.3.7.7.2.1 and 6.3.7.7.2.2, filling in the blanks accordingly and the text found in subsections 6.3.7.7.2.3.1 and 6.3.7.7.2.3.2, if appropriate.

6.3.7.7.2.1 E. coli are bacteria whose presence indicates that the water may be contaminated with human or animal wastes. Human pathogens in these wastes can cause short-term effects, such as diarrhea, cramps, nausea, headaches, or other symptoms. They may pose a greater health risk for infants, young children, the elderly, and people with severely compromised immune systems. We found E. coli bacteria, indicating the need to look for potential problems in water treatment or distribution. When this occurs, we are required to conduct assessment(s) to identify problems and to correct any problems that were found during these assessments.

6.3.7.7.2.2 We were required to complete a Level 2 assessment because we found E. coli in our water system. In addition, we were required to take [INSERT NUMBER OF CORRECTIVE ACTIONS] corrective actions and we completed [INSERT NUMBER OF CORRECTIVE ACTIONS] of these actions.

6.3.7.7.2.3 Any system that has failed to complete the required assessment or correct all identified sanitary defects, is in violation of the treatment technique requirement and must also include one or both of the following statements, as appropriate:

6.3.7.7.2.3.1 We failed to conduct the required assessment.

6.3.7.7.2.3.2 We failed to correct all sanitary defects that were identified during the assessment that we conducted.

6.3.7.7.3 If a system detects E. coli and has violated the E. coli MCL, in addition to completing the table as required in subsection 6.3.4.4, the system must include one or more of the following statements to describe any noncompliance, as applicable:

6.3.7.7.3.1 We had an E. coli-positive repeat sample following a total coliform-positive routine sample.

6.3.7.7.3.2 We had a total coliform-positive repeat sample following an E. coli-positive routine sample.

6.3.7.7.3.3 We failed to take all required repeat samples following an E. coli-positive routine sample.

6.3.7.7.3.4 We failed to test for E. coli when any repeat sample tests positive for total coliform.

6.3.7.7.4 If a system detects E. coli and has not violated the E. coli MCL, in addition to completing the table as required in subsection 6.3.4.4, the system may include a statement that explains that although they have detected E. coli they are not in violation of the E. coli MCL.

6.4 Required additional health information:

6.4.1 All reports must prominently display the following language:

Some people may be more vulnerable to contaminants in drinking water than the general population. Immuno-compromised persons such as persons with cancer undergoing chemotherapy, persons who have undergone organ transplants, people with HIV/AIDS or other immune system disorders, some elderly, and infants can be particularly at risk from infections. These people should seek advice about drinking water from their health care providers. EPA/CDC guidelines on appropriate means to lessen the risk of infection by Cryptosporidium and other microbial contaminants are available from the Safe Drinking Water Hotline (800-426-4791).

6.4.2 Ending in the reports due by July 1, 2001 a system which detects arsenic at levels above 0.025 mg/L, but below 0.05 mg/L and beginning in the report due by July 1, 2002 a system that detects arsenic above 0.005 mg/L and up to and including 0.010 mg/L:

6.4.2.1 Must include in its report a short informational statement about arsenic, using language such as: While your drinking water meets EPA’s standard for arsenic, it does contain low levels of arsenic. EPA’s standard balances the current understanding of arsenic’s possible health effects against the costs of removing arsenic from drinking water. EPA continues to research the health effects of low levels of arsenic, which is a mineral known to cause cancer in humans at high concentrations and is linked to other health effects such as skin damage and circulatory problems.

6.4.2.2 May write its own educational statement, but only in consultation with the Division.

6.4.3 A system which detects nitrate at levels above 5 mg/l, but below the MCL:

6.4.3.1 Must include a short informational statement about the impacts of nitrate on children using language such as: Nitrate in drinking water at levels above 10 ppm is a health risk for infants of less than six months of age. High nitrate levels in drinking water can cause blue baby syndrome. Nitrate levels may rise quickly for short periods of time because of rainfall or agricultural activity. If you are caring for an infant you should ask advice from your health care provider.

6.4.3.2 May write its own educational statement, but only in consultation with the Division.

6.4.4 Every report must include the following lead-specific information:

6.4.4.1 A short informational statement about lead in drinking water and its effects on children. The statement must include the following information:

If present, elevated levels of lead can cause serious health problems, especially for pregnant women and young children. Lead in drinking water is primarily from materials and components associated with service lines and home plumbing. [NAME OF UTILITY] is responsible for providing high quality drinking water, but cannot control the variety of materials used in plumbing components. When your water has been sitting for several hours you can minimize the potential for lead exposure by flushing your tap for 30 seconds to 2 minutes before using water for drinking or cooking. If you are concerned about lead in your water, you may wish to have your water tested. Information on lead in drinking water, testing methods, and steps you can take to minimize exposure is available from the Safe Drinking Water Hotline or at http://www.epa.gov/safewater/lead.

6.4.4.2 A system may write its own educational statement, but only in consultation with the Division.

6.4.5 Community water systems that detect TTHM above 0.080 mg/L, but below the MCL in subsection 9.2.1.2 as an annual average, monitored and calculated under the provisions of 40 CFR section 141.30, must include health effects language for TTHMs prescribed in subsection 6.6.

6.5 Report delivery and recordkeeping:

6.5.1 Except as provided in subsection 6.5.7, each community water system must mail or otherwise directly deliver one copy of the report to each customer.

6.5.2 The system must make a good faith effort to reach consumers who do not get water bills, using means recommended by the Division. EPA expects that an adequate good faith effort will be tailored to the consumers who are served by the system but are not bill-paying customers, such as renters or workers. A good faith effort to reach consumers would include a mix of methods appropriate to the particular system such as: Posting the reports on the Internet; mailing to postal patrons in metropolitan areas; advertising the availability of the report in the news media; publication in a local newspaper; posting in public places such as cafeterias or lunch rooms of public buildings; delivery of multiple copies for distribution by single-biller customers such as apartment buildings or large private employers; delivery to community organizations.

6.5.3 No later than the date the system is required to distribute the report to its customers, each community water system must mail a copy of the report to the Division, followed within ten (10) days by a certification that the report has been distributed to customers, and that the information is correct and consistent with the compliance monitoring data previously submitted to the Division.

6.5.4 No later than the date the system is required to distribute the report to its customers, each community water system must deliver the report to any other agency or clearinghouse identified by the Division.

6.5.5 Each community water system must make its reports available to the public upon request.

6.5.6 Each community water system serving 100,000 or more persons must post its current year’s report to a publicly-accessible site on the Internet.

6.5.7 Community water systems serving fewer than 10,000 persons may forego the requirements under subsection 6.5.2 if they comply with the following:

6.5.7.1 Such systems must:

6.5.7.1.1 Publish the reports in one or more local newspapers serving the area in which the system is located;

6.5.7.1.2 Inform the customers that the reports will not be mailed, either in the newspapers in which the reports are published or by other means approved by the Division; and

6.5.7.1.3 Make the reports available to the public upon request.

6.5.7.2 Systems serving 500 or fewer persons may forego the requirements of subsections 6.5.7.1 and 6.5.7.2 if they provide notice at least once per year to their customers by mail, door-to-door delivery or by posting in an appropriate location that the report is available upon request.

6.5.8 Any system subject to this section must retain copies of its consumer confidence report for no less than 5 years.

6.6 Consumer Confidence Report Requirements for Regulated Contaminants

Appendix a to Section 6.0 - regulated contaminants

Key:

AL=Action Level

MCL=Maximum Contaminant Level

MCLG=Maximum Contaminant Level Goal

MFL=million fibers per liter

MRDL=Maximum Residual Disinfectant Level

MRDLG=Maximum Residual Disinfectant Level Goal

mrem/year=millirems per year (a measure of radiation absorbed by the body)

N/A=Not Applicable

NTU=Nephelometric Turbidity Units (a measure of water clarity)

pCi/l=picocuries per liter (a measure of radioactivity)

ppm=parts per million, or milligrams per liter (mg/l)

ppb=parts per billion, or micrograms per liter (μg/l)

ppt=parts per trillion, or nanograms per liter

ppq=parts per quadrillion, or picograms per liter

TT=Treatment Technique

**History**
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *25 DE Reg. 713 (01/01/22)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *5 DE Reg. 2121 (05/01/02)*
- *9 DE Reg. 999 (12/01/05)*
- *15 DE Reg. 73 (07/01/12)*
- *17 DE Reg. 439 (10/01/13)*
- *19 DE Reg. 517 (12/01/15)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *25 DE Reg. 713 (01/01/22)*

##### **16 Del. Admin. Code § 4462-7.0** Microbiological Requirements {#sec-4462-7.0 omnilex-key=us-de-regs-official--title-16--4462-7.0}

7.1 Sampling:

7.1.1 Sampling Sites:

7.1.1.1 Compliance with bacteriological requirements of these regulations shall be based on examinations of samples collected at sites which are representative of water throughout the distribution system according to a written sample siting plan. These plans are subject to Division review and revision.

7.1.2 CWS Sampling Frequency:

7.1.1.2 The supplier of water for a CWS shall sample for total coliform bacteria at least monthly in numbers proportional to the population served by the system in accordance with the following:

7.1.3 Reduced Monitoring Frequency for CWSs:

7.1.3.1 If a CWS serving twenty-five (25) to one thousand (1000) persons has no history of total coliform contamination in its current configuration and a sanitary survey conducted in the past five (5) years shows that the system is supplied solely by a protected ground water source and is free of sanitary defects, the Division may reduce the monitoring frequency specified above, except that in no case may the Division reduce the monitoring frequency to less than one (1) sample per quarter. The Division must approve the reduced monitoring frequency in writing.

7.1.4 NCWS Sampling Frequency:

7.1.4.1 The supplier of water for a NCWS and NTNCWS shall sample for total coliform bacteria in accordance with the following:

7.1.4.1.1 A NCWS and NTNCWS using only ground water (except ground water under the direct influence of surface water) and serving one thousand (1000) persons or fewer must monitor each calendar quarter that the system provides water to the public, except that the Division may reduce this monitoring frequency, in writing, if a sanitary survey shows that the system is free of sanitary defects. Beginning June 29, 1994 the Division cannot reduce the monitoring frequency for a NCWS using only ground water (except ground water under the direct influence of surface water) and serving one thousand (1000) persons or fewer to less than once per year.

7.1.4.1.2 A NCWS and NTNCWS using only ground water (except ground water under the direct influence of surface water) and serving more than one thousand (1000) persons during any month must monitor at the same frequency as a like-sized CWS, as specified in subsection 7.1.2, except the Division may reduce this monitoring frequency, in writing, for any month the system serves one thousand (1000) persons or fewer. The Division cannot reduce the monitoring frequency to less than once per year. For systems using ground water under the direct influence of surface water, subsection 7.1.4.1.4 applies.

7.1.4.1.3 A NCWS and NTNCWS using surface water, in total or in part, must monitor at the same frequency as a like-sized CWS, as specified in subsection 7.1.2, regardless of the number of persons it serves.

7.1.4.1.4 A NCWS and NTNCWS using ground water under the direct influence of surface water must monitor at the same frequency as a like-sized CWS, as specified in subsection 7.1.2. The system must begin monitoring at this frequency beginning six (6) months after the Division determines that the ground water is under the direct influence of surface water.

7.1.5 Special Sampling for Surface Water Systems: A PWS that uses surface water or ground water under the direct influence of surface water, and does not practice filtration in compliance with subsection 1.1, must collect at least one (1) sample near the first service connection each day the turbidity level of the source water, measured as specified in subsection 7.1.2, exceeds one (1) NTU. This sample must be analyzed for the presence of total coliforms. When one (1) or more turbidity measurements in any day exceed one (1) NTU, the system must collect this coliform sample within twenty-four (24) hours of the first exceedance, unless the Division determines that the system, for logistical reasons outside the system's control, cannot have the sample analyzed within thirty (30) hours of collection. Sample results from this coliform monitoring must be included in determining the MCL for total coliforms.

7.1.6 Monthly/Quarterly Sampling: The PWS must collect samples at regular time intervals throughout the month/quarter, except that a system that uses only ground water (except ground water under the direct influence of surface water) and serves 4,900 persons or fewer, may collect all required samples on a single day if they are taken from different sites.

7.1.7 Special Purpose Samples: Special purpose samples, such as those taken to determine whether disinfection practices are sufficient following pipe placement, replacement, or repair, shall not be used to determine compliance with the MCL for total coliforms. Repeat samples taken pursuant to subsection 7.2.3 are not considered special purpose samples, and must be used to determine compliance with the MCL for total coliforms.

7.2 Microbiological MCLs

7.2.1 Total Coliforms, Fecal Coliforms and E. coli:

7.2.1.1 The MCLs for microbiological contaminants are in accordance with the following:

7.2.1.1.1 Until December 31, 2015, compliance with the MCL is based on the presence or absence of total coliforms in a sample, rather than coliform density in accordance with the following:

7.2.1.1.1.1 For a system which collects at least forty (40) samples per month/quarter, if no more than 5.0 percent of the samples collected during a month/quarter are total coliform-positive, the system is in compliance with the MCL for total coliforms.

7.2.1.1.1.2 For a system which collects fewer than forty (40) samples per month/quarter, if no more than one (1) sample collected during a month/quarter is total coliform-positive, the system is in compliance with the MCL for total coliforms.

7.2.1.1.2 Until December 31, 2015 any fecal coliform-positive repeat sample, or E. coli-positive repeat sample, or any total coliform-positive repeat sample following a fecal coliform-positive or E. coli-positive routine sample constitutes a violation of the MCL for total coliforms. For purposes of the public notification requirements in subsection 4.2, this is a violation that may pose an acute risk to health.

7.2.1.1.3 Beginning January 1, 2016, a system is in compliance with the MCL for E. coli for samples taken under the provisions of subsection 7.4 unless any of the conditions identified in subsections 7.2.1.1.3.1 through 7.2.1.1.3.4 occur. For purposes of the public notification requirements in Section 4.0, violation of the MCL may pose an acute risk to public health.

7.2.1.1.3.1 The system has an E. coli-positive repeat sample following a total coliform-positive routine sample.

7.2.1.1.3.2 The system has a total coliform-positive sample following an E. coli-positive routine sample.

7.2.1.1.3.3 The system fails to take all required repeat samples following an E. coli-positive routine sample.

7.2.1.1.3.4 The system fails to test for E. coli when any repeat sample tests positive for total coliforms.

7.2.1.1.4 Until December 31, 2015, a public water system must determine compliance with the MCL for total coliforms in subsections 7.2.1.11 and 7.2.1.1.2 for each month in which it is required to monitor for total coliforms. Beginning January 1, 2016, a public water system must determine compliance with the MCL for E. coli in subsection 7.2.1.1.3 for each month in which it is required to monitor for total coliforms.

7.2.1.1.5 The Administrator, pursuant to section 1412 of the Safe Drinking Water Act, hereby identifies the following as the best technology, treatment techniques, or other means available for achieving compliance with the MCL for total coliforms in subsections 7.2.1.1.1 and 7.2.1.1.2 and for achieving compliance with the MCL for E. coli in subsection 7.2.1.1.3:

7.2.1.1.5.1 Protection of wells from fecal contamination by coliforms by appropriate placement and construction;

7.2.1.1.5.2 Maintenance of a disinfectant residual throughout the distribution system;

7.2.1.1.5.3 Proper maintenance of the distribution system including appropriate pipe replacement and repair procedures, main flushing programs, proper operation and maintenance of storage tanks and reservoirs, cross-connection and control, and continual maintenance of positive water pressure in all parts of the distribution system;

7.2.1.1.5.4 Filtration and/or disinfection of surface water, as described in Sections 16.0, 17.0, 19.0 and 20.0, or disinfection of ground water, as described in Section 8.0, using strong oxidants such as chlorine, chlorine dioxide, or ozone; and

7.2.1.1.5.5 For systems using groundwater, compliance with the requirements of an EPA-approved State Wellhead Protection Program under section 1428 of the Safe Drinking Water Act (SDWA).

7.2.1.1.6 The Administrator, pursuant to section 1412 of the Safe Drinking Water Act, hereby identifies the technology, treatment techniques, or other means available identified in subsection 7.2.1.1.5 as affordable technology, treatment techniques, or other means available to systems serving 10,000 or fewer people for achieving compliance with the MCL for total coliforms in subsections 7.2.1.1.1 and 7.2.1.1.2 and for achieving compliance with the MCL for E. coli in subsection 7.2.1.1.3.

7.2.2 Invalidation of Total Coliform-Positive Samples:

7.2.2.1 Each total coliform positive sample counts in compliance calculations, unless it has been invalidated by the Division. Invalidated samples do not count toward the minimum monitoring frequency. The Division may invalidate a sample if:

7.2.2.1.1 The analytical laboratory acknowledges that improper sample analysis caused the positive result;

7.2.2.1.2 A laboratory must invalidate a total coliform sample (unless total coliforms are detected) if the sample produces a turbid culture in the absence of gas production using an analytical method where gas formation is examined (e.g. the Multiple-Tube Fermentation Technique), produces a turbid culture in the absence of an acid reaction in the Presence-Absence (P-A) Coliform Test, or exhibits confluent growth or produces colonies too numerous to count with an analytical method using a membrane filter (e.g. Membrane Filter Technique). If a laboratory invalidates a sample because of such interference, the system must collect another sample from the same location as the original sample within twenty-four (24) hours of being notified of the interference problem, and have it analyzed for the presence of total coliforms. The system must continue to re-sample within twenty-four (24) hours and have the samples analyzed until it obtains a valid result. The Division may waive the twenty-four (24) hour time limit on a case-by-case basis.

7.2.2.1.3 The Division determines that the contamination is a domestic or other non-distribution system plumbing problem on the basis that one (1) or more repeat samples taken at the same tap as the original total coliform positive sample is total coliform positive, but all repeat samples at nearby sampling locations that are within five (5) service connections of the original tap are total coliform negative. A total coliform-positive sample cannot be invalidated under this provision if the PWS has only one (1) service connection; or

7.2.2.1.4 The Division has substantial grounds to believe that a total coliform positive result is due to some circumstance or condition which does not reflect water quality in the distribution system, if:

7.2.2.1.4.1 The basis for this determination is documented in writing.

7.2.2.1.4.2 This document is signed and approved by the Division.

7.2.2.1.4.3 The documentation is made available to EPA and the public. The written documentation must state the specific cause of the total coliform-positive sample, and what action the system has taken, or will take, to correct this problem.

7.2.2.1.4.4 The system must still collect all repeat samples required under subsection 7.2.3 to determine compliance with the MCL for total coliforms in subsection 7.2.1.

7.2.3 Repeat Monitoring:

7.2.3.1 When a total coliform-positive sample result is obtained, repeat sampling must be done in accordance with the following:

7.2.3.1.1 If a routine sample is total-coliform positive, the PWS must collect a set of repeat samples within twenty-four (24) hours of being notified of the positive result. A system which collects more than one (1) routine sample/month must collect no fewer than three (3) repeat samples for each total coliform positive sample found. A system which collects one (1) routine sample/month or fewer must collect no fewer than four (4) repeat samples for each total coliform positive sample found. The Division may extend the twenty-four (24) hour limit on a case-by-case basis if the system has a logistical problem in collecting the repeat samples within twenty-four hours that is beyond its control. In the case of an extension, the Division must specify how much time the system has to collect the repeat samples.

7.2.3.1.2 The system must collect at least one (1) repeat sample from the sampling tap where the original total coliform-positive sample was taken, and at least one (1) repeat sample at a tap within five (5) service connections upstream and at least one (1) repeat sample at a tap within five (5) service connections downstream of the original sampling site. If a total coliform-positive sample is at the end of the distribution system, or one (1) away from the end of the distribution system, the Division may waive the requirement to collect at least one (1) repeat sample upstream or downstream of the original sampling site.

7.2.3.1.3 The system must collect all repeat samples on the same day, except that the Division may allow a system with a single service connection to collect the required set of repeat samples over a four (4) day period or to collect a larger volume repeat sample(s) in one (1) or more sample containers of any size, as long as the total volume collected is at least four hundred (400) ml [three hundred (300) ml for systems which collect more than one (1) routine sample/month].

7.2.3.1.4 If one (1) or more repeat samples in the set is total coliform-positive, the PWS must collect an additional set of repeat samples in the manner specified in subsections 7.2.1, 7.2.2, and 7.2.3. The additional samples must be collected within twenty-four (24) hours of being notified of the positive result, unless the Division extends the limit as provided in subsection 7.2.1. The system must repeat this process until either total coliforms are not detected in one (1) complete set of repeat samples or the system determines that the MCL for total coliforms in subsection 7.2.1 has been exceeded and notifies the Division.

7.2.3.1.5 If a system collecting fewer than five (5) routine samples per month has one (1) or more total coliform-positive samples and the Division does not invalidate the sample(s) under subsection 7.2.2, it must collect at least five (5) routine samples during the next month the system provides water to the public, except that the Division may waive this requirement if the conditions of subsections 7.2.3.1.5.1 and 7.2.3.1.5.2 are met. The Division cannot waive the requirement for a system to collect repeat samples in subsections 7.2.3.1.1, 7.2.3.1.2, 7.2.3.1.3, and 7.2.3.1.4.

7.2.3.1.5.1 The Division may waive the requirements to collect five (5) routine samples the next month the system provides water to the public if the Division, or an agent approved by the Division, performs a site visit before the end of the next month the system provides water to the public. Although a sanitary survey need not be performed, the site visit must be sufficiently detailed to allow the Division to determine whether additional monitoring and/or any corrective action is needed. The Division cannot approve an employee of the system to perform the site visit, even if the employee is an agent approved by the Division to perform sanitary surveys.

7.2.3.1.5.2 The Division may waive the requirements to collect five (5) routine samples the next month the system provides water to the public if the Division has determined why the sample was total coliform-positive and establishes that the system has corrected the problem or will correct the problem before the end of the next month the system serves water to the public. In this case, the Division must document this decision to waive the following month's additional monitoring requirement in writing, have it approved and signed by the supervisor of the Division official who recommends such a decision, and make this document available to the EPA and the public. The written documentation must describe the specific cause of the total coliform-positive sample and what action the system has taken and/or will take to correct this problem. The Division cannot waive the requirement to collect five (5) routine samples the next month the system provides water to the public solely on the grounds that all coliform samples are total coliform-negative. Under this paragraph, a system must still take at least one (1) routine sample before the end of the next month it serves water to the public and use it to determine compliance with the MCL for total coliforms in subsection 7.2.1, unless the Division has determined that the system has corrected the contamination problem before the system took the set of repeat samples required in subsections 7.2.3.1.1, 7.2.3.1.2, 7.2.3.1.3, and 7.2.3.1.4, and all repeat samples were total coliform negative.

7.2.3.1.6 After a systems collects a routine sample and before it learns the results of the analysis of that sample, if it collects another routine sample(s) from within five (5) adjacent service connections of the initial sample, and the initial sample, after analysis, is found to contain total coliforms, then the system may count the subsequent sample(s) as a repeat sample instead of a routine sample.

7.2.3.1.7 Results of all routine and repeat samples not invalidated by the Division must be included in determining compliance with the MCL for total coliforms in subsection 7.2.1.

7.2.4 Initial/Subsequent Sanitary Surveys: PWSs which do not collect five (5) or more routine samples/month must undergo an initial sanitary survey by June 29, 1994 for CWSs and June 29, 1999 for NCWSs. Thereafter, systems must undergo another sanitary survey every five (5) years, except that NCWSs using only protected and disinfected ground water, as defined by the Division, must undergo subsequent sanitary surveys at least every ten (10) years after the initial sanitary survey. The Division must review the results of each sanitary survey to determine whether the existing monitoring frequency is adequate and what additional measures, if any, the system needs to undertake to improve drinking water quality. In conducting a sanitary survey of a system using ground water in a State having an EPA-approved wellhead protection program under section 1428 of the SDWA, information on sources of contamination within the delineated wellhead protection area that was collected in the course of developing and implementing the program should be considered instead of collecting new information, if the information was collected since the last time the system was subject to a sanitary survey. Sanitary surveys must be performed by the Division and the system is responsible for ensuring the survey takes place.

7.2.5 Fecal Coliforms/Escherichia coli (E. coli) Testing:

7.2.5.1 When a total coliform-positive sample result is obtained, the sample must be analyzed for fecal coliforms or E. coli in accordance with the following:

7.2.5.1.1 If any routine or repeat sample is total coliform-positive, the system must analyze that total coliform-positive culture medium to determine if fecal coliforms are present, except that the system may test for E. coli in lieu of fecal coliforms. If fecal coliforms or E. coli are present, the system shall notify the Division by the end of the day when the system is notified of the test result, unless the system is notified of the result after the Division office is closed, in which case the system shall notify the Division before the end of the next business day.

7.2.5.1.2 The Division has the discretion to allow the PWS, on a case by case basis, to forgo fecal coliform or E. coli testing on a total coliform-positive sample if that system assumes that the total coliform-positive sample is fecal coliform-positive or E. coli positive. Accordingly, the system shall notify the Division as specified in subsection 7.2.1.1.1 and the provisions of subsection 7.2.1.1.2 apply.

7.2.6 Response to Violation. A PWS which has exceeded the MCL for total coliforms in subsection 7.2.1 must report the violation to the Division no later than the end of the next business day after it learns of the violation, and notify the public in accordance with subsection 4.1. A PWS which has failed to comply with a coliform monitoring requirement, including the sanitary survey requirement, must report the monitoring violation to the Division within ten (10) days after the system discovers the violation, and notify the public in accordance with subsection 4.1.

7.2.7 The provisions of subsections 7.1.1 and 7.2.4 are applicable until December 31, 2015. The provisions of subsections 7.2.2, 7.2.3, 7.2.5, 7.3 and 7.2.6 are applicable until all required repeat monitoring under subsection 7.2.3 and fecal coliform or E. coli testing under subsection 7.2.5 that was initiated by a total coliform-positive sample taken before January 1, 2016 is completed, as well as analytical method, reporting, recordkeeping, public notification, and consumer confidence report requirements associated with that monitoring and testing. Beginning January 1, 2016, the provisions of subsection 7.4 are applicable, with systems required to begin regular monitoring at the same frequency as the system-specific frequency required on December 31, 2015.

7.3 Analytical Requirements

7.3.1 Analytical Methodology. The standard sample volume required for total coliform analysis, regardless of analytical method used, is one hundred (100) ml. Public water systems need only determine the presence or absence of total coliforms. A determination of total coliform density is not required. Public water systems must conduct total coliform analyses in accordance with 40 CFR 141.21(f)(3). Copies may be obtained from the Office of Drinking Water.

7.4 Revised Total Coliform Rule

7.4.1 General.

7.4.1.1 General. The provisions of this subpart include both maximum contaminant level and treatment technique requirements.

7.4.1.2 Applicability. The provisions of this subpart apply to all public water systems.

7.4.1.3 Compliance date. Systems must comply with the provisions of this subpart beginning January 1, 2016, unless otherwise specified in this subpart.

7.4.1.4 Implementation with EPA as State. Systems falling under direct oversight of EPA, where EPA acts as the State, must comply with decisions made by EPA for implementation of subpart Y. EPA has authority to establish such procedures and criteria as are necessary to implement subpart Y.

7.4.1.5 Violations of national primary drinking water regulations. Failure to comply with the applicable requirements of §§141.851 through 141.861, including requirements established by the State pursuant to these provisions, is a violation of the national primary drinking water regulations under subpart Y.

7.4.2 Analytical methods and laboratory certification.

7.4.2.1 Analytical methodology.

7.4.2.1.1 The standard sample volume required for analysis, regardless of analytical method used, is 100 ml.

7.4.2.1.2 Systems need only determine the presence or absence of total coliforms and E. coli; a determination of density is not required.

7.4.2.1.3 The time from sample collection to initiation of test medium incubation may not exceed 30 hours. Systems are encouraged but not required to hold samples below 10° C during transit.

7.4.2.1.4 If water having residual chlorine (measured as free, combined, or total chlorine) is to be analyzed, sufficient sodium thiosulfate (Na2S2O3) must be added to the sample bottle before sterilization to neutralize any residual chlorine in the water sample. Dechlorination procedures are addressed in Section 9060A.2 of Standard Methods for the Examination of Water and Wastewater (20th and 21st editions).

7.4.2.1.5 Systems must conduct total coliform and E. coli analyses in accordance with one of the analytical methods in the following table or one of the alternative methods listed in Appendix A subsection 7.4.2.

7.4.2.2 Laboratory certification. Systems must have all compliance samples required under this subpart analyzed by a laboratory certified by the EPA or a primacy State to analyze drinking water samples. The laboratory used by the system must be certified for each method (and associated contaminant(s)) used for compliance monitoring analyses under this rule.

7.4.2.3 Incorporation by reference. The standards required in this section are incorporated by reference into this section with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. To enforce any edition other than that specified in this section, EPA must publish notice of change in the Federal Register and the material must be available to the public. All approved material is available for inspection either electronically at www.regulations.gov, in hard copy at the Water Docket, or from the sources indicated below. The Docket ID is EPA– HQ–OW–2008–0878. Hard copies of these documents may be viewed at the Water Docket in the EPA Docket Center, (EPA/DC) EPA West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is 1–202–566–1744, and the telephone number for the Water Docket is 1–202–566–2426. Copyrighted materials are only available for viewing in hard copy. These documents are also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 1–202–741–6030 or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

7.4.2.3.1 American Public Health Association, 800 I Street, NW., Washington, DC 20001.

7.4.2.3.1.1 ‘‘Standard Methods for the Examination of Water and Wastewater,’’ 20th edition (1998):

7.4.2.3.1.1.1 Standard Methods 9221, ‘‘Multiple-Tube Fermentation Technique for Members of the Coliform Group,’’ B.1, B.2, ‘‘Standard Total Coliform Fermentation Technique.’’

7.4.2.3.1.1.2 Standard Methods 9221, ‘‘Multiple-Tube Fermentation Technique for Members of the Coliform Group,’’ D.1, D.2, ‘‘Presence-Absence (P–A) Coliform Test.’’

7.4.2.3.1.1.3 Standard Methods 9222, ‘‘Membrane Filter Technique for Members of the Coliform Group,’’ B, ‘‘Standard Total Coliform Membrane Filter Procedure.’’

7.4.2.3.1.1.4 Standard Methods 9222, ‘‘Membrane Filter Technique for Members of the Coliform Group,’’ C, ‘‘Delayed-Incubation Total Coliform Procedure.’’

7.4.2.3.1.1.5 Standard Methods 9223, ‘‘Enzyme Substrate Coliform Test,’’ B, ‘‘Enzyme Substrate Test,’’ Colilert® and Colisure®.

7.4.2.3.1.1.6 Standard Methods 9221, ‘‘Multiple Tube Fermentation Technique for Members of the Coliform Group,’’ F.1, ‘‘Escherichia coli Procedure: EC–MUG medium.’’

7.4.2.3.1.1.7 Standard Methods 9222, ‘‘Membrane Filter Technique for Members of the Coliform Group,’’ G.1.c(2), ‘‘Escherichia coli Partition Method: EC broth with MUG (EC–MUG).’’

7.4.2.3.1.1.8 Standard Methods 9222, ‘‘Membrane Filter Technique for Members of the Coliform Group,’’ G.1.c(1), ‘‘Escherichia coli Partition Method: NA–MUG medium.’’

7.4.2.3.1.2 ‘‘Standard Methods for the Examination of Water and Wastewater,’’ 21st edition (2005):

7.4.2.3.1.2.1 Standard Methods 9221, ‘‘Multiple-Tube Fermentation Technique for Members of the Coliform Group,’’ B.1, B.2, ‘‘Standard Total Coliform Fermentation Technique.’’

7.4.2.3.1.2.2 Standard Methods 9221, ‘‘Multiple-Tube Fermentation Technique for Members of the Coliform Group,’’ D.1, D.2, ‘‘Presence-Absence (P–A) Coliform Test.’’

7.4.2.3.1.2.3 Standard Methods 9222, ‘‘Membrane Filter Technique for Members of the Coliform Group,’’ B, ‘‘Standard Total Coliform Membrane Filter Procedure.’’

7.4.2.3.1.2.4 Standard Methods 9222, ‘‘Membrane Filter Technique for Members of the Coliform Group,’’ C, ‘‘Delayed-Incubation Total Coliform Procedure.’’

7.4.2.3.1.2.5 Standard Methods 9223, ‘‘Enzyme Substrate Coliform Test,’’ B, ‘‘Enzyme Substrate Test,’’ Colilert® and Colisure®.

7.4.2.3.1.2.6 Standard Methods 9221, ‘‘Multiple Tube Fermentation Technique for Members of the Coliform Group,’’ F.1, ‘‘Escherichia coli Procedure: EC–MUG medium.’’

7.4.2.3.1.2.7 Standard Methods 9222, ‘‘Membrane Filter Technique for Members of the Coliform Group,’’ G.1.c(2), ‘‘Escherichia coli Partition Method: EC broth with MUG (EC–MUG).’’

7.4.2.3.1.2.8 Standard Methods 9222, ‘‘Membrane Filter Technique for Members of the Coliform Group,’’ G.1.c(1), ‘‘Escherichia coli Partition Method: NA–MUG medium.’’

7.4.2.3.1.3 ‘‘Standard Methods Online’’ available at http://www.standardmethods.org:

7.4.2.3.1.3.1 Standard Methods Online 9221, ‘‘Multiple-Tube Fermentation Technique for Members of the Coliform Group’’ (1999), B.1, B.2–99, ‘‘Standard Total Coliform Fermentation Technique.’’

7.4.2.3.1.3.2 Standard Methods Online 9221, ‘‘Multiple-Tube Fermentation Technique for Members of the Coliform Group’’ (1999), D.1, D.2–99, ‘‘Presence-Absence (P–A) Coliform Test.’’

7.4.2.3.1.3.3 Standard Methods Online 9222, ‘‘Membrane Filter Technique for Members of the Coliform Group’’ (1997), B–97, ‘‘Standard Total Coliform Membrane Filter Procedure.’’

7.4.2.3.1.3.4 Standard Methods Online 9222, ‘‘Membrane Filter Technique for Members of the Coliform Group’’ (1997), C–97, ‘‘Delayed-Incubation Total Coliform Procedure.’’

7.4.2.3.1.3.5 Standard Methods Online 9223, ‘‘Enzyme Substrate Coliform Test’’ (1997), B–97, ‘‘Enzyme Substrate Test’’, Colilert® and Colisure®.

7.4.2.3.2 Charm Sciences, Inc., 659 Andover Street, Lawrence, MA 01843–1032, telephone 1–800–343–2170:

7.4.2.3.2.1 E*Colite®—‘‘Charm E*ColiteTM Presence/Absence Test for Detection and Identification of Coliform Bacteria and Escherichia coli in Drinking Water,’’ January 9, 1998.

7.4.2.3.2.2 Reserved

7.4.2.3.3 CPI International, Inc., 5580 Skylane Blvd., Santa Rosa, CA, 95403, telephone 1–800–878–7654:

7.4.2.3.3.1 modified Colitag®, ATP D05–0035—‘‘Modified ColitagTM Test Method for the Simultaneous Detection of E. coli and other Total Coliforms in Water,’’ August 28, 2009.

7.4.2.3.3.2 Reserved

7.4.2.3.4 EMD Millipore (a division of Merck KGaA, Darmstadt Germany), 290 Concord Road, Billerica, MA 01821, telephone 1–800–645–5476:

7.4.2.3.4.1 Chromocult—‘‘Chromocult® Coliform Agar Presence/Absence Membrane Filter Test Method for Detection and Identification of Coliform Bacteria and Escherichia coli for Finished Waters,’’ November 2000, Version 1.0.

7.4.2.3.4.2 Readycult®—‘‘Readycult® Coliforms 100 Presence/Absence Test for Detection and Identification of Coliform Bacteria and Escherichia coli in Finished Waters,’’ January 2007, Version 1.1.

7.4.2.3.5 EPA’s Water Resource Center (MC–4100T), 1200 Pennsylvania Avenue NW., Washington, DC 20460, telephone 1–202–566–1729:

7.4.2.3.5.1 EPA Method 1604, EPA 821–R–02–024—‘‘EPA Method 1604: Total Coliforms and Escherichia coli in Water by Membrane Filtration Using a Simultaneous Detection Technique (MI Medium),’’ September 2002, http://www.epa.gov/nerlcwww/1604sp02.pdf.

7.4.2.3.5.2 Reserved

7.4.2.3.6 Hach Company, P.O. Box 389, Loveland, CO 80539, telephone 1–800–604–3493:

7.4.2.3.6.1 m-ColiBlue24®—‘‘Membrane Filtration Method m-ColiBlue24® Broth,’’ Revision 2, August 17, 1999.

7.4.2.3.6.2 Reserved

7.4.3 General monitoring requirements for all public water systems.

7.4.3.1 Sample siting plans.

7.4.3.1.1 Systems must develop a written sample siting plan that identifies sampling sites and a sample collection schedule that are representative of water throughout the distribution system not later than December 31, 2015. These plans are subject to Division review and revision. Systems must collect total coliform samples according to the written sample siting plan. Monitoring required by 7.4.4 through 7.4.8 may take place at a customer’s premise, dedicated sampling station, or other designated compliance sampling location. Routine and repeat sample sites and any sampling points necessary to meet the requirements of subpart S must be reflected in the sampling plan.

7.4.3.1.2 Systems must collect samples at regular time intervals throughout the month, except that systems that use only ground water and serve 4,900 or fewer people may collect all required samples on a single day if they are taken from different sites.

7.4.3.1.3 Systems must take at least the minimum number of required samples even if the system has had an E. coli MCL violation or has exceeded the coliform treatment technique triggers in subsection 7.4.9.1.

7.4.3.1.4 A system may conduct more compliance monitoring than is required by this subpart to investigate potential problems in the distribution system and use monitoring as a tool to assist in uncovering problems. A system may take more than the minimum number of required routine samples and must include the results in calculating whether the coliform treatment technique trigger in subsections 7.4.9.1.1.1 and 7.4.9.1.1.2 has been exceeded only if the samples are taken in accordance with the existing sample siting plan and are representative of water throughout the distribution system.

7.4.3.1.5 Systems must identify repeat monitoring locations in the sample siting plan. Unless the provisions of subsections 7.4.3.1.5.1 or 7.4.3.1.5.2 are met, the system must collect at least one repeat sample from the sampling tap where the original total coliform-positive sample was taken, and at least one repeat sample at a tap within five service connections upstream and at least one repeat sample at a tap within five service connections downstream of the original sampling site. If a total coliform-positive sample is at the end of the distribution system, or one service connection away from the end of the distribution system, the system must still take all required repeat samples. However, the Division may allow an alternative sampling location in lieu of the requirement to collect at least one repeat sample upstream or downstream of the original sampling site. Except as provided for in subsection 7.4.3.1.5.2, systems required to conduct triggered source water monitoring under subsection 8.3.1 must take ground water source sample(s) in addition to repeat samples required under this subpart.

7.4.3.1.5.1 Systems may propose repeat monitoring locations to the Division that the system believes to be representative of a pathway for contamination of the distribution system. A system may elect to specify either alternative fixed locations or criteria for selecting repeat sampling sites on a situational basis in a standard operating procedure (SOP) in its sample siting plan. The system must design its SOP to focus the repeat samples at locations that best verify and determine the extent of potential contamination of the distribution system area based on specific situations. The Division may modify the SOP or require alternative monitoring locations as needed.

7.4.3.1.5.2 Ground water systems serving 1,000 or fewer people may propose repeat sampling locations to the Division that differentiate potential source water and distribution system contamination(e.g., by sampling at entry points to the distribution system). A ground water system with a single well required to conduct triggered source water monitoring may, with written Division approval, take one of its repeat samples at the monitoring location required for triggered source water monitoring under subsection 8.3.1 if the system demonstrates to the Division’s satisfaction that the sample siting plan remains representative of water quality in the distribution system. If approved by the Division, the system may use that sample result to meet the monitoring requirements in both subsection 8.3.1 and this section.

7.4.3.1.5.2.1 If a repeat sample taken at the monitoring location required for triggered source water monitoring is E. coli-positive, the system has violated the E. coli MCL and must also comply with subsection 8.3.1.2.3. If a system takes more than one repeat sample at the monitoring location required for triggered source water monitoring, the system may reduce the number of additional source water samples required under subsection 8.3.1.2.3 by the number of repeat samples taken at that location that were not E. coli-positive.

7.4.3.1.5.2.2 If a system takes more than one repeat sample at the monitoring location required for triggered source water monitoring under subsection 8.3.1, and more than one repeat sample is E. coli-positive, the system has violated the E. coli MCL and must also comply with subsection 8.4.1.

7.4.3.1.5.2.3 If all repeat samples taken at the monitoring location required for triggered source water monitoring are E. coli-negative and a repeat sample taken at a monitoring location other than the one required for triggered source water monitoring is E. coli-positive, the system has violated the E. coli MCL, but is not required to comply with subsection 8.3.1.2.3.

7.4.3.1.6 States may review, revise, and approve, as appropriate, repeat sampling proposed by systems under subsections 7.4.3.1.5.1 and 7.4.3.1.5.2. The system must demonstrate that the sample siting plan remains representative of the water quality in the distribution system. The Division may determine that monitoring at the entry point to the distribution system (especially for undisinfected ground water systems) is effective to differentiate between potential source water and distribution system problems.

7.4.3.2 Special purpose samples. Special purpose samples, such as those taken to determine whether disinfection practices are sufficient following pipe placement, replacement, or repair, must not be used to determine whether the coliform treatment technique trigger has been exceeded. Repeat samples taken pursuant to subsection 7.4.8 are not considered special purpose samples, and must be used to determine whether the coliform treatment technique trigger has been exceeded.

7.4.3.3 Invalidation of total coliform samples. A total coliform-positive sample invalidated under subsection 7.4.3.3 does not count toward meeting the minimum monitoring requirements of this subpart.

7.4.3.3.1 The Division may invalidate a total coliform-positive sample only if the conditions of subsections 7.4.3.3.1.1, 7.4.3.3.1.2 or 7.4.3.3.1.3 are met.

7.4.3.3.1.1 The laboratory establishes that improper sample analysis caused the total coliform-positive result.

7.4.3.3.1.2 The Division, on the basis of the results of repeat samples collected as required under subsection 7.4.8.1, determines that the total coliform-positive sample resulted from a domestic or other non-distribution system plumbing problem. The Division cannot invalidate a sample on the basis of repeat sample results unless all repeat sample(s) collected at the same tap as the original total coliform positive sample are also total coliform positive, and all repeat samples collected at a location other than the original tap are total coliform-negative (e.g., a State cannot invalidate a total coliform-positive sample on the basis of repeat samples if all the repeat samples are total coliform-negative, or if the system has only one service connection).

7.4.3.3.1.3 The Division has substantial grounds to believe that a total coliform-positive result is due to a circumstance or condition that does not reflect water quality in the distribution system. In this case, the system must still collect all repeat samples required under subsection 7.4.8.1, and use them to determine whether a coliform treatment technique trigger in subsection 7.4.9 has been exceeded. To invalidate a total coliform-positive sample under this paragraph, the decision and supporting rationale must be documented in writing, and approved and signed by the supervisor of the Division official who recommended the decision. The Division must make this document available to EPA and the public. The written documentation must state the specific cause of the total coliform-positive sample, and what action the system has taken, or will take, to correct this problem. The Division may not invalidate a total coliform-positive sample solely on the grounds that all repeat samples are total coliform negative.

7.4.3.3.2 A laboratory must invalidate a total coliform sample (unless total coliforms are detected) if the sample produces a turbid culture in the absence of gas production using an analytical method where gas formation is examined (e.g., the Multiple-Tube Fermentation Technique), produces a turbid culture in the absence of an acid reaction in the Presence-Absence (P–A) Coliform Test, or exhibits confluent growth or produces colonies too numerous to count with an analytical method using a membrane filter (e.g., Membrane Filter Technique). If a laboratory invalidates a sample because of such interference, the system must collect another sample from the same location as the original sample within 24 hours of being notified of the interference problem, and have it analyzed for the presence of total coliforms. The system must continue to re-sample within 24 hours and have the samples analyzed until it obtains a valid result. The Division may waive the 24-hour time limit on a case-by-case basis. Alternatively, the Division may implement criteria for waiving the 24-hour sampling time limit to use in lieu of case-by-case extensions.

7.4.4 Routine monitoring requirements for non-community water systems serving 1,000 or fewer people using only ground water.

7.4.4.1 General.

7.4.4.1.1 The provisions of this section apply to non-community water systems using only ground water (except ground water under the direct influence of surface water, as defined in Section 2.0) and serving 1,000 or fewer people.

7.4.4.1.2 Following any total coliform positive sample taken under the provisions of this section, systems must comply with the repeat monitoring requirements and E. coli analytical requirements in subsection 7.4.8.

7.4.4.1.3 Once all monitoring required by this section and subsection 7.4.8 for a calendar month has been completed, systems must determine whether any coliform treatment technique triggers specified in subsection 7.4.9 have been exceeded. If any trigger has been exceeded, systems must complete assessments as required by subsection 7.4.9.

7.4.4.1.4 For the purpose of determining eligibility for remaining on or qualifying for quarterly monitoring under the provisions of subsection 7.4.4.6.4 and 7.4.4.7.2, respectively, for transient non-community water systems, the Division may elect to not count monitoring violations under subsection 7.4.10.3.1 if the missed sample is collected no later than the end of the monitoring period following the monitoring period in which the sample was missed. The system must collect the make-up sample in a different week than the routine sample for that monitoring period and should collect the sample as soon as possible during the monitoring period. The Division may not use this provision under subsection 7.4.4.8. This authority does not affect the provisions of subsections 7.4.10.3.1 and 7.4.11.1.4.

7.4.4.2 Monitoring frequency for total coliforms. Systems must monitor each calendar quarter that the system provides water to the public, except for seasonal systems or as provided under subsections 7.4.4.3 through 7.4.4.8 and 7.4.4.10. Seasonal systems must meet the monitoring requirements of subsection 7.4.4.9.

7.4.4.3 Transition to subsection 7.4 (Revised Total Coliform Rule).

7.4.4.3.1 Systems, including seasonal systems, must continue to monitor according to the total coliform monitoring schedules under subsection 7.1 that were in effect on December 31, 2015, unless any of the conditions for increased monitoring in subsection 7.4.4.6 are triggered on or after January 1, 2016, or unless otherwise directed by the Division.

7.4.4.3.2 Beginning January 1, 2016, the Division must perform a special monitoring evaluation during each sanitary survey to review the status of the system, including the distribution system, to determine whether the system is on an appropriate monitoring schedule. After the Division has performed the special monitoring evaluation during each sanitary survey, the Division may modify the system’s monitoring schedule, as necessary, or it may allow the system to stay on its existing monitoring schedule, consistent with the provisions of this section. The Division may not allow systems to begin less frequent monitoring under the special monitoring evaluation unless the system has already met the applicable criteria for less frequent monitoring in this section. For seasonal systems on quarterly or annual monitoring, this evaluation must include review of the approved sample siting plan, which must designate the time period(s) for monitoring based on site-specific considerations (e.g., during periods of highest demand or highest vulnerability to contamination). The seasonal system must collect compliance samples during these time periods.

7.4.4.4 Annual site visits. Systems on annual monitoring, including seasonal systems, must have an initial and recurring annual site visit by the Division that is equivalent to a Level 2 assessment or an annual voluntary Level 2 assessment that meets the criteria in subsection 7.4.9.2 to remain on annual monitoring. The periodic required sanitary survey may be used to meet the requirement for an annual site visit for the year in which the sanitary survey was completed.

7.4.4.5 Criteria for annual monitoring. The Division may reduce the monitoring frequency for a well-operated ground water system from quarterly routine monitoring to no less than annual monitoring, if the system demonstrates that it meets the criteria for reduced monitoring in subsections 7.4.4.5.1 through 7.4.4.5.3, except for a system that has been on increased monitoring under the provisions of subsection 7.4.4.6. A system on increased monitoring under subsection 7.4.4.6 must meet the provisions of subsection 7.4.4.7 to go to quarterly monitoring and must meet the provisions of subsection 7.4.4.8 to go to annual monitoring.

7.4.4.5.1 The system has a clean compliance history for a minimum of 12 months;

7.4.4.5.2 The most recent sanitary survey shows that the system is free of sanitary defects or has corrected all identified sanitary defects, has a protected water source, and meets approved construction standards; and

7.4.4.5.3 The Division has conducted an annual site visit within the last 12 months and the system has corrected all identified sanitary defects. The system may substitute a Level 2 assessment that meets the criteria in subsection 7.4.9.2 for the Division’s annual site visit.

7.4.4.6 Increased Monitoring Requirements for systems on quarterly or annual monitoring. A system on quarterly or annual monitoring that experiences any of the events identified in subsections 7.4.4.6.1 through 7.4.4.6.4 must begin monthly monitoring the month following the event. A system on annual monitoring that experiences the event identified in subsection 7.4.4.6.5 must begin quarterly monitoring the quarter following the event. The system must continue monthly or quarterly monitoring until the requirements in subsection 7.4.4.7 for quarterly monitoring or subsection 7.4.4.8 for annual monitoring are met. A system on monthly monitoring for reasons other than those identified in subsections 7.4.4.6.1 through 7.4.4.6.4 is not considered to be on increased monitoring for the purposes of subsections 7.4.4.7 and 7.4.4.8.

7.4.4.6.1 The system triggers a Level 2 assessment or two Level 1 assessments under the provisions of subsection 7.4.9 in a rolling 12-month period.

7.4.4.6.2 The system has an E. coli MCL violation.

7.4.4.6.3 The system has a coliform treatment technique violation.

7.4.4.6.4 The system has two subsection 7.4 monitoring violations or one subsection 7.4 monitoring violation and one Level 1 assessment under the provisions of subsection 7.4.9 in a rolling 12-month period for a system on quarterly monitoring.

7.4.4.6.5 The system has one subsection 7.4 monitoring violation for a system on annual monitoring.

7.4.4.7 Requirements for returning to quarterly monitoring. The Division may reduce the monitoring frequency for a system on monthly monitoring triggered under 7.4.4.6 to quarterly monitoring if the system meets the criteria in subsections 7.4.4.7.1 and 7.4.4.7.2.

7.4.4.7.1 Within the last 12 months, the system must have a completed sanitary survey or a site visit by the Division or a voluntary Level 2 assessment by a party approved by the Division, be free of sanitary defects, and have a protected water source; and

7.4.4.7.2 The system must have a clean compliance history for a minimum of 12 months.

7.4.4.8 Requirements for systems on increased monitoring to qualify for annual monitoring. The Division may reduce the monitoring frequency for a system on increased monitoring under subsection 7.4.4.6 if the system meets the criteria in subsection 7.4.4.7 plus the criteria in subsections 7.4.4.8.1 and 7.4.4.8.2.

7.4.4.8.1 An annual site visit by the Division and correction of all identified sanitary defects. The system may substitute a voluntary Level 2 assessment by a party approved by the Division for the Division’s annual site visit in any given year.

7.4.4.8.2 The system must have in place or adopt one or more additional enhancements to the water system barriers to contamination in subsections 7.4.4.8.2.1 through 7.4.4.8.2.5.

7.4.4.8.2.1 Cross-connection control, as approved by the Division.

7.4.4.8.2.2 An operator certified by the Division or regular visits by a circuit rider certified by the Division.

7.4.4.8.2.3 Continuous disinfection entering the distribution system and a residual in the distribution system in accordance with criteria specified by the Division.

7.4.4.8.2.4 Demonstration of maintenance of at least a 4-log removal or inactivation of viruses as provided for under subsection 8.4.2.3.

7.4.4.8.2.5 Other equivalent enhancements to water system barriers as approved by the Division.

7.4.4.9 Seasonal systems.

7.4.4.9.1 Beginning January 1, 2016, all seasonal systems must demonstrate completion of a Division-approved start-up procedure, which may include a requirement for startup sampling prior to serving water to the public.

7.4.4.9.2 A seasonal system must monitor every month that it is in operation unless it meets the criteria in subsections 7.4.4.9.2.1 through 7.4.4.9.2.3 to be eligible for monitoring less frequently than monthly beginning January 1, 2016, except as provided under subsection 7.4.4.3.

7.4.4.9.2.1 Seasonal systems monitoring less frequently than monthly must have an approved sample siting plan that designates the time period for monitoring based on site-specific considerations (e.g., during periods of highest demand or highest vulnerability to contamination). Seasonal systems must collect compliance samples during this time period.

7.4.4.9.2.2 To be eligible for quarterly monitoring, the system must meet the criteria in subsection 7.4.4.7.

7.4.4.9.2.3 To be eligible for annual monitoring, the system must meet the criteria under subsection 7.4.4.8.

7.4.4.9.3 The Division may exempt any seasonal system from some or all of the requirements for seasonal systems if the entire distribution system remains pressurized during the entire period that the system is not operating, except that systems that monitor less frequently than monthly must still monitor during the vulnerable period designated by the Division.

7.4.4.10 Additional routine monitoring the month following a total coliform positive sample. Systems collecting samples on a quarterly or annual frequency must conduct additional routine monitoring the month following one or more total coliform-positive samples (with or without a Level 1 treatment technique trigger). Systems must collect at least three routine samples during the next month, except that the Division may waive this requirement if the conditions of subsections 7.4.4.10.1, 7.4.4.10.2 or 7.4.4.10.3 are met. Systems may either collect samples at regular time intervals throughout the month or may collect all required routine samples on a single day if samples are taken from different sites. Systems must use the results of additional routine samples in coliform treatment technique trigger calculations under subsection 7.4.9.1.

7.4.4.10.1 The Division may waive the requirement to collect three routine samples the next month in which the system provides water to the public if the Division, or an agent approved by the Division, performs a site visit before the end of the next month in which the system provides water to the public. Although a sanitary survey need not be performed, the site visit must be sufficiently detailed to allow the Division to determine whether additional monitoring and/or any corrective action is needed. The Division cannot approve an employee of the system to perform this site visit, even if the employee is an agent approved by the Division to perform sanitary surveys.

7.4.4.10.2 The Division may waive the requirement to collect three routine samples the next month in which the system provides water to the public if the Division has determined why the sample was total coliform-positive and has established that the system has corrected the problem or will correct the problem before the end of the next month in which the system serves water to the public. In this case, the Division must document this decision to waive the following month’s additional monitoring requirement in writing, have it approved and signed by the supervisor of the Division official who recommends such a decision, and make this document available to the EPA and public. The written documentation must describe the specific cause of the total coliform-positive sample and what action the system has taken and/or will take to correct this problem.

7.4.4.10.3 The Division may not waive the requirement to collect three additional routine samples the next month in which the system provides water to the public solely on the grounds that all repeat samples are total coliform negative. If the Division determines that the system has corrected the contamination problem before the system takes the set of repeat samples required in subsection 7.4.8, and all repeat samples were total coliform-negative, the Division may waive the requirement for additional routine monitoring the next month.

7.4.5 Routine monitoring requirements for community water systems serving 1,000 or fewer people using only ground water.

7.4.5.1 General.

7.4.5.1.1 The provisions of this section apply to community water systems using only ground water (except ground water under the direct influence of surface water, as defined in Section 2.0) and serving 1,000 or fewer people.

7.4.5.1.2 Following any total coliform positive sample taken under the provisions of this section, systems must comply with the repeat monitoring requirements and E. coli analytical requirements in subsection 7.4.8.

7.4.5.1.3 Once all monitoring required by this section and subsection 7.4.8 for a calendar month has been completed, systems must determine whether any coliform treatment technique triggers specified in subsection 7.4.9 have been exceeded. If any trigger has been exceeded, systems must complete assessments as required by subsection 7.4.9.

7.4.5.2 Monitoring frequency for total coliforms. The monitoring frequency for total coliforms is one sample/month, except as provided for under subsections 7.4.5.3 through 7.4.5.6.

7.4.5.3 Transition to subsection 7.4.

7.4.5.3.1 All systems must continue to monitor according to the total coliform monitoring schedules under subsection 7.1 that were in effect on December 31, 2015, unless any of the conditions in subsection 7.4.5.5 are triggered on or after January 1, 2016, or unless otherwise directed by the Division.

7.4.5.3.2 Beginning January 1, 2016, the Division must perform a special monitoring evaluation during each sanitary survey to review the status of the system, including the distribution system, to determine whether the system is on an appropriate monitoring schedule. After the Division has performed the special monitoring evaluation during each sanitary survey, the Division may modify the system’s monitoring schedule, as necessary, or it may allow the system to stay on its existing monitoring schedule, consistent with the provisions of this section. The Division may not allow systems to begin less frequent monitoring under the special monitoring evaluation unless the system has already met the applicable criteria for less frequent monitoring in this section.

7.4.5.4 Criteria for reduced monitoring.

7.4.5.4.1 The Division may reduce the monitoring frequency from monthly monitoring to no less than quarterly monitoring if the system is in compliance with Division certified operator provisions and demonstrates that it meets the criteria in subsections 7.4.5.4.1.1 through 7.4.5.4.1.3. A system that loses its certified operator must return to monthly monitoring the month following that loss.

7.4.5.4.1.1 The system has a clean compliance history for a minimum of 12 months.

7.4.5.4.1.2 The most recent sanitary survey shows the system is free of sanitary defects (or has an approved plan and schedule to correct them and is in compliance with the plan and the schedule), has a protected water source and meets approved construction standards.

7.4.5.4.1.3 The system meets at least one of the following criteria:

7.4.5.4.1.3.1 An annual site visit by the Division that is equivalent to a Level 2 assessment or an annual Level 2 assessment by a party approved by the Division and correction of all identified sanitary defects (or an approved plan and schedule to correct them and is in compliance with the plan and schedule).

7.4.5.4.1.3.2 Cross-connection control, as approved by the Division.

7.4.5.4.1.3.3 Continuous disinfection entering the distribution system and a residual in the distribution system in accordance with criteria specified by the Division.

7.4.5.4.1.3.4 Demonstration of maintenance of at least a 4-log removal or inactivation of viruses as provided for under subsection 8.4.2.3.

7.4.5.4.3.1.5 Other equivalent enhancements to water system barriers as approved by the Division.

7.4.5.4.2 Reserved

7.4.5.5 Return to routine monthly monitoring requirements. Systems on quarterly monitoring that experience any of the events in subsections 7.4.5.5.1 through 7.4.5.5.4 must begin monthly monitoring the month following the event. The system must continue monthly monitoring until it meets the reduced monitoring requirements in subsection 7.4.5.4.

7.4.5.5.1 The system triggers a Level 2 assessment or two Level 1 assessments in a rolling 12-month period.

7.4.5.5.2 The system has an E. coli MCL violation.

7.4.5.5.3 The system has a coliform treatment technique violation.

7.4.5.5.4 The system has two subsection 7.4 monitoring violations in a rolling 12-month period.

7.4.5.6 Additional routine monitoring the month following a total coliform positive sample. Systems collecting samples on a quarterly frequency must conduct additional routine monitoring the month following one or more total coliform-positive samples (with or without a Level 1 treatment technique trigger). Systems must collect at least three routine samples during the next month, except that the Division may waive this requirement if the conditions of subsection 7.4.5.6.1, 7.4.5.6.2, or 7.4.5.6.3 are met. Systems may either collect samples at regular time intervals throughout the month or may collect all required routine samples on a single day if samples are taken from different sites. Systems must use the results of additional routine samples in coliform treatment technique trigger calculations.

7.4.5.6.1 The Division may waive the requirement to collect three routine samples the next month in which the system provides water to the public if the Division, or an agent approved by the Division, performs a site visit before the end of the next month in which the system provides water to the public. Although a sanitary survey need not be performed, the site visit must be sufficiently detailed to allow the Division to determine whether additional monitoring and/or any corrective action is needed. The Division cannot approve an employee of the system to perform this site visit, even if the employee is an agent approved by the Division to perform sanitary surveys.

7.4.5.6.2 The Division may waive the requirement to collect three routine samples the next month in which the system provides water to the public if the Division has determined why the sample was total coliform-positive and has established that the system has corrected the problem or will correct the problem before the end of the next month in which the system serves water to the public. In this case, the Division must document this decision to waive the following month’s additional monitoring requirement in writing, have it approved and signed by the supervisor of the Division official who recommends such a decision, and make this document available to the EPA and the public. The written documentation must describe the specific cause of the total coliform-positive sample and what action the system has taken and/or will take to correct this problem.

7.4.5.6.3 The Division may not waive the requirement to collect three additional routine samples the next month in which the system provides water to the public solely on the grounds that all repeat samples are total coliform negative. If the Division determines that the system has corrected the contamination problem before the system takes the set of repeat samples required in subsection 7.4.8, and all repeat samples were total coliform-negative, the Division may waive the requirement for additional routine monitoring the next month.

7.4.6 Routine monitoring requirements for surface water or ground water under the direct influence of surface water public water systems serving 1,000 or fewer people.

7.4.6.1 General.

7.4.6.1.1 The provisions of this section apply to surface water or ground water under the direct influence of surface water public water systems of this part serving 1,000 or fewer people.

7.4.6.1.2 Following any total coliform positive sample taken under the provisions of this section, systems must comply with the repeat monitoring requirements and E. coli analytical requirements in subsection 7.4.8.

7.4.6.1.3 Once all monitoring required by this section and subsection 7.4.8 for a calendar month has been completed, systems must determine whether any coliform treatment technique triggers specified in 7.4.9 have been exceeded. If any trigger has been exceeded, systems must complete assessments as required by subsection 7.4.9.

7.4.6.1.4 Seasonal systems.

7.4.6.1.4.1 Beginning January 1, 2016, all seasonal systems must demonstrate completion of a Division approved start-up procedure, which may include a requirement for start-up sampling prior to serving water to the public.

7.4.6.1.4.2 The Division may exempt any seasonal system from some or all of the requirements for seasonal systems if the entire distribution system remains pressurized during the entire period that the system is not operating.

7.4.6.2 Routine monitoring frequency for total coliforms. Surface water or ground water under the direct influence of surface water systems of this part (including consecutive systems) must monitor monthly. Systems may not reduce monitoring.

7.4.6.3 Unfiltered subpart H systems. In accordance with subsection 17.1 a surface water or ground water under the direct influence of surface water system that does not practice filtration shall be prohibited.

7.4.7 Routine monitoring requirements for public water systems serving more than 1,000 people.

7.4.7.1 General.

7.4.7.1.1 The provisions of this section apply to public water systems serving more than 1,000 persons.

7.4.7.1.2 Following any total coliform positive sample taken under the provisions of this section, systems must comply with the repeat monitoring requirements and E. coli analytical requirements in subsection 7.4.8.

7.4.7.1.3 Once all monitoring required by this section and subsection 7.4.8 for a calendar month has been completed, systems must determine whether any coliform treatment technique triggers specified in subsection 7.4.9 have been exceeded. If any trigger has been exceeded, systems must complete assessments as required by subsection 7.4.9.

7.4.7.1.4 Seasonal systems.

7.4.7.1.4.1 Beginning January 1, 2016, all seasonal systems must demonstrate completion of a Division approved start-up procedure, which may include a requirement for start-up sampling prior to serving water to the public.

7.4.7.1.4.2 The Division may exempt any seasonal system from some or all of the requirements for seasonal systems if the entire distribution system remains pressurized during the entire period that the system is not operating.

7.4.7.2 Monitoring frequency for total coliforms. The monitoring frequency for total coliforms is based on the population served by the system, as follows:

7.4.7.3 Unfiltered subpart H systems. In accordance with subsection 16.1 a surface water or ground water under the direct influence of surface water system that does not practice filtration shall be prohibited.

7.4.7.4 Reduced monitoring. Systems may not reduce monitoring, except for non-community water systems using only ground water (and not ground water under the direct influence of surface water) serving 1,000 or fewer people in some months and more than 1,000 persons in other months. In months when more than 1,000 persons are served, the systems must monitor at the frequency specified in subsection 7.4.7.2. In months when 1,000 or fewer people are served, the Division may reduce the monitoring frequency, in writing, to a frequency allowed under subsection 7.4.4 for a similarly situated system that always serves 1,000 or fewer people, taking into account the provisions in subsections 7.4.4.5 through 7.4.4.7.

7.4.8 Repeat monitoring and E. coli requirements.

7.4.8.1 Repeat monitoring.

7.4.8.1.1 If a sample taken under subsections 7.4.4 through 7.4.7 is total coliform-positive, the system must collect a set of repeat samples within 24 hours of being notified of the positive result. The system must collect no fewer than three repeat samples for each total coliform-positive sample found. The Division may extend the 24-hour limit on a case-by-case basis if the system has a logistical problem in collecting the repeat samples within 24 hours that is beyond its control. Alternatively, the Division may implement criteria for the system to use in lieu of case-by-case extensions. In the case of an extension, the Division must specify how much time the system has to collect the repeat samples. The Division cannot waive the requirement for a system to collect repeat samples in subsections 7.4.8.1.1 through 7.4.8.1.3.

7.4.8.1.2 The system must collect all repeat samples on the same day, except that the Division may allow a system with a single service connection to collect the required set of repeat samples over a three-day period or to collect a larger volume repeat sample(s) in one or more sample containers of any size, as long as the total volume collected is at least 300 ml.

7.4.8.1.3 The system must collect an additional set of repeat samples in the manner specified in subsections 7.4.8.1.1 through 7.4.8.1.3 if one or more repeat samples in the current set of repeat samples is total coliform positive. The system must collect the additional set of repeat samples within 24 hours of being notified of the positive result, unless the Division extends the limit as provided in subsection 7.4.8.1.1. The system must continue to collect additional sets of repeat samples until either total coliforms are not detected in one complete set of repeat samples or the system determines that a coliform treatment technique trigger specified in subsection 7.4.9.1 has been exceeded as a result of a repeat sample being total coliform-positive and notifies the Division. If a trigger identified in subsection 7.4.9 is exceeded as a result of a routine sample being total coliform positive, systems are required to conduct only one round of repeat monitoring for each total coliform positive routine sample.

7.4.8.1.4 After a system collects a routine sample and before it learns the results of the analysis of that sample, if it collects another routine sample(s) from within five adjacent service connections of the initial sample, and the initial sample, after analysis, is found to contain total coliforms, then the system may count the subsequent sample(s) as a repeat sample instead of as a routine sample.

7.4.8.1.5 Results of all routine and repeat samples taken under subsections 7.4.4 through 7.4.8 not invalidated by the Division must be used to determine whether a coliform treatment technique trigger specified in subsection 7.4.9 has been exceeded.

7.4.8.2 Escherichia coli (E. coli) testing.

7.4.8.2.1 If any routine or repeat sample is total coliform-positive, the system must analyze that total coliform-positive culture medium to determine if E. coli are present. If E. coli are present, the system must notify the Division by the end of the day when the system is notified of the test result, unless the system is notified of the result after the Division office is closed and the Division does not have either an after-hours phone line or an alternative notification procedure, in which case the system must notify the Division before the end of the next business day.

7.4.8.2.2 The Division has the discretion to allow a system, on a case-by-case basis, to forgo E. coli testing on a total coliform-positive sample if that system assumes that the total coliform-positive sample is E. coli-positive. Accordingly, the system must notify the Division as specified in subsection 7.4.8.2.1 of this section and the provisions of subsection 7.2.1.1.3 apply.

7.4.9 Coliform treatment technique triggers and assessment requirements for protection against potential fecal contamination.

7.4.9.1 Treatment technique triggers. Systems must conduct assessments in accordance with subsection 7.4.9.2 after exceeding treatment technique triggers in subsections 7.4.9.1.1 and 7.4.9.1.2.

7.4.9.1.1 Level 1 treatment technique triggers.

7.4.9.1.1.1 For systems taking 40 or more samples per month, the system exceeds 5.0% total coliform-positive samples for the month.

7.4.9.1.1.2 For systems taking fewer than 40 samples per month, the system has two or more total coliform-positive samples in the same month.

7.4.9.1.1.3 The system fails to take every required repeat sample after any single total coliform-positive sample.

7.4.9.1.2 Level 2 treatment technique triggers.

7.4.9.1.2.1 An E. coli MCL violation, as specified in subsection 7.4.10.1.

7.4.9.1.2.2 A second Level 1 trigger as defined in subsection 7.4.9.1.1, within a rolling 12-month period, unless the Division has determined a likely reason that the samples that caused the first Level 1 treatment technique trigger were total coliform positive and has established that the system has corrected the problem.

7.4.9.1.2.3 For systems with approved annual monitoring, a Level 1 trigger in two consecutive years.

7.4.9.2 Requirements for assessments.

7.4.9.2.1 Systems must ensure that Level 1 and 2 assessments are conducted in order to identify the possible presence of sanitary defects and defects in distribution system coliform monitoring practices. Level 2 assessments must be conducted by parties approved by the Division.

7.4.9.2.2 When conducting assessments, systems must ensure that the assessor evaluates minimum elements that include review and identification of inadequacies in sample sites; sampling protocol; sample processing; atypical events that could affect distributed water quality or indicate that distributed water quality was impaired; changes in distribution system maintenance and operation that could affect distributed water quality (including water storage); source and treatment considerations that bear on distributed water quality, where appropriate (e.g., small ground water systems); and existing water quality monitoring data. The system must conduct the assessment consistent with any Division directives that tailor specific assessment elements with respect to the size and type of the system and the size, type, and characteristics of the distribution system.

7.4.9.2.3 Level 1 Assessments. A system must conduct a Level 1 assessment consistent with Division requirements if the system exceeds one of the treatment technique triggers in subsection 7.4.9.1.1.

7.4.9.2.3.1 The system must complete a Level 1 assessment as soon as practical after any trigger in subsection 7.4.9.1.1. In the completed assessment form, the system must describe sanitary defects detected, corrective actions completed, and a proposed timetable for any corrective actions not already completed. The assessment form may also note that no sanitary defects were identified. The system must submit the completed Level 1 assessment form to the Division within 30 days after the system learns that it has exceeded a trigger.

7.4.9.2.3.2 If the Division reviews the completed Level 1 assessment and determines that the assessment is not sufficient (including any proposed timetable for any corrective actions not already completed), the Division must consult with the system. If the Division requires revisions after consultation, the system must submit a revised assessment form to the Division on an agreed-upon schedule not to exceed 30 days from the date of the consultation.

7.4.9.2.3.3 Upon completion and submission of the assessment form by the system, the Division must determine if the system has identified a likely cause for the Level 1 trigger and, if so, establish that the system has corrected the problem, or has included a schedule acceptable to the Division for correcting the problem.

7.4.9.2.4 Level 2 Assessments. A system must ensure that a Level 2 assessment consistent with Division requirements is conducted if the system exceeds one of the treatment technique triggers in subsection 7.4.9.1.2. The system must comply with any expedited actions or additional actions required by the Division in the case of an E. coli MCL violation.

7.4.9.2.4.1 The system must ensure that a Level 2 assessment is completed by the Division or by a party approved by the Division as soon as practical after any trigger in subsection 7.4.9.1.2. The system must submit a completed Level 2 assessment form to the Division within 30 days after the system learns that it has exceeded a trigger. The assessment form must describe sanitary defects detected, corrective actions completed, and a proposed timetable for any corrective actions not already completed. The assessment form may also note that no sanitary defects were identified.

7.4.9.2.4.2 The system may conduct Level 2 assessments if the system has staff or management with the certification or qualifications specified by the Division unless otherwise directed by the Division.

7.4.9.2.4.3 If the Division reviews the completed Level 2 assessment and determines that the assessment is not sufficient (including any proposed timetable for any corrective actions not already completed), the Division must consult with the system. If the Division requires revisions after consultation, the system must submit a revised assessment form to the Division on an agreed-upon schedule not to exceed 30 days.

7.4.9.2.4.4 Upon completion and submission of the assessment form by the system, the Division must determine if the system has identified a likely cause for the Level 2 trigger and determine whether the system has corrected the problem, or has included a schedule acceptable to the Division for correcting the problem.

7.4.9.3 Corrective Action. Systems must correct sanitary defects found through either Level 1 or 2 assessments conducted under subsection 7.4.9.2. For corrections not completed by the time of submission of the assessment form, the system must complete the corrective action(s) in compliance with a timetable approved by the Division in consultation with the system. The system must notify the Division when each scheduled corrective action is completed.

7.4.9.4 Consultation. At any time during the assessment or corrective action phase, either the water system or the Division may request a consultation with the other party to determine the appropriate actions to be taken. The system may consult with the Division on all relevant information that may impact on its ability to comply with a requirement of this subpart, including the method of accomplishment, an appropriate timeframe, and other relevant information.

7.4.10 Violations.

7.4.10.1 E. coli MCL Violation. A system is in violation of the MCL for E. coli when any of the conditions identified in subsections 7.4.10.1.1 through 7.4.10.1.4 occur.

7.4.10.1.1 The system has an E. coli-positive repeat sample following a total coliform positive routine sample.

7.4.10.1.2 The system has a total coliform positive repeat sample following an E. coli-positive routine sample.

7.4.10.1.3 The system fails to take all required repeat samples following an E. coli-positive routine sample.

7.4.10.1.4 The system fails to test for E. coli when any repeat sample tests positive for total coliform.

7.4.10.2 Treatment technique violation.

7.4.10.2.1 A treatment technique violation occurs when a system exceeds a treatment technique trigger specified in subsection 7.4.9.1 and then fails to conduct the required assessment or corrective actions within the timeframe specified in subsections 7.4.9.2 and 7.4.9.3.

7.4.10.2.2 A treatment technique violation occurs when a seasonal system fails to complete a Division-approved start-up procedure prior to serving water to the public.

7.4.10.3 Monitoring violations.

7.4.10.3.1 Failure to take every required routine or additional routine sample in a compliance period is a monitoring violation.

7.4.10.3.2 Failure to analyze for E. coli following a total coliform-positive routine sample is a monitoring violation.

7.4.10.4 Reporting violations.

7.4.10.4.1 Failure to submit a monitoring report or completed assessment form after a system properly conducts monitoring or assessment in a timely manner is a reporting violation.

7.4.10.4.2 Failure to notify the Division following an E. coli-positive sample as required by subsection 7.4.8.2.1 in a timely manner is a reporting violation.

7.4.10.4.3 Failure to submit certification of completion of Division-approved start-up procedure by a seasonal system is a reporting violation.

7.4.11 Reporting and recordkeeping.

7.4.11.1 Reporting.

7.4.11.1.1 E. coli.

7.4.11.1.1.1 A system must notify the Division by the end of the day when the system learns of an E. coli MCL violation, unless the system learns of the violation after the Division office is closed and the Division does not have either an after-hours phone line or an alternative notification procedure, in which case the system must notify the Division before the end of the next business day, and notify the public in accordance with Section 4.0.

7.4.11.1.1.2 A system must notify the Division by the end of the day when the system is notified of an E. coli-positive routine sample, unless the system is notified of the result after the Division office is closed and the Division does not have either an after-hours phone line or an alternative notification procedure, in which case the system must notify the Division before the end of the next business day.

7.4.11.1.2 A system that has violated the treatment technique for coliforms in subsection 7.4.9 must report the violation to the Division no later than the end of the next business day after it learns of the violation, and notify the public in accordance with Section 4.0.

7.4.11.1.3 A system required to conduct an assessment under the provisions of subsection 7.4.9 must submit the assessment report within 30 days. The system must notify the Division in accordance with subsection 7.4.9.3 when each scheduled corrective action is completed for corrections not completed by the time of submission of the assessment form.

7.4.11.1.4 A system that has failed to comply with a coliform monitoring requirement must report the monitoring violation to the Division within 10 days after the system discovers the violation, and notify the public in accordance with Section 4.0.

7.4.11.1.5 A seasonal system must certify, prior to serving water to the public, that it has complied with the Division-approved start-up procedure.

7.4.11.2 Recordkeeping.

7.4.11.2.1 The system must maintain any assessment form, regardless of who conducts the assessment, and documentation of corrective actions completed as a result of those assessments, or other available summary documentation of the sanitary defects and corrective actions taken under subsection 7.4.9 for Division review. This record must be maintained by the system for a period not less than five years after completion of the assessment or corrective action.

7.4.11.2.2 The system must maintain a record of any repeat sample taken that meets Division criteria for an extension of the 24-hour period for collecting repeat samples as provided for under subsection 7.4.8.1.1.

**History**
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *25 DE Reg. 713 (01/01/22)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *5 DE Reg. 2121 (05/01/02)*
- *9 DE Reg. 999 (12/01/05)*
- *15 DE Reg. 73 (07/01/12)*
- *17 DE Reg. 439 (10/01/13)*
- *19 DE Reg. 517 (12/01/15)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *25 DE Reg. 713 (01/01/22)*

##### **16 Del. Admin. Code § 4462-8.0** Ground Water Rule {#sec-4462-8.0 omnilex-key=us-de-regs-official--title-16--4462-8.0}

8.1 General requirements and applicability

8.1.1 Scope of this section. The requirements of the ground water rule constitute National Primary Drinking Water Regulations.

8.1.2 Applicability. This section applies to all public water systems that use ground water except that it does not apply to public water systems that combine all of their ground water with surface water or with ground water under the direct influence of surface water prior to treatment under subpart H. For the purposes of this section, “ground water system” is defined as any public water system meeting this applicability statement, including consecutive systems receiving finished ground water.

8.1.3 General requirements. Systems subject to this section must comply with the following requirements:

8.1.3.1 Sanitary survey information requirements for all ground water systems as described in subsection 8.2.

8.1.3.2 Microbial source water monitoring requirements for ground water systems that do not treat all of their ground water to at least 99.99 percent (4-log) treatment of viruses (using inactivation, removal, or a Division-approved combination of 4-log virus inactivation and removal) before or at the first customer as described in subsection 8.3.

8.1.3.3 Treatment technique requirements, described in subsection 8.4, that apply to ground water systems that have fecally contaminated source waters, as determined by source water monitoring conducted under subsection 8.3, or that have significant deficiencies that are identified by the Division or that are identified by EPA under SDWA section 1445. A ground water system with fecally contaminated source water or with significant deficiencies subject to the treatment technique requirements of this section must implement one or more of the following corrective action options: correct all significant deficiencies; provide an alternate source of water; eliminate the source of contamination; or provide treatment that reliably achieves at least 4-log treatment of viruses (using inactivation, removal, or a Division-approved combination of 4-log virus inactivation and removal) before or at the first customer.

8.1.3.4 Ground water systems that provide at least 4-log treatment of viruses (using inactivation, removal, or a Division-approved combination of 4-log virus inactivation and removal) before or at the first customer are required to conduct compliance monitoring to demonstrate treatment effectiveness, as described in subsection 8.4.2.

8.1.3.5 If requested by the Division, ground water systems must provide the Division with any existing information that will enable the State to perform a hydrogeologic sensitivity assessment. For the purposes of this section, “hydrogeologic sensitivity assessment” is a determination of whether ground water systems obtain water from hydrogeologically sensitive settings.

8.1.4 Compliance date. Ground water systems must comply, unless otherwise noted, with the requirements of this section beginning December 1, 2009.

8.2 Sanitary surveys for ground water systems.

8.2.1 Ground water systems must provide the Division, at the Division's request, any existing information that will enable the Division to conduct a sanitary survey.

8.2.2 For the purposes of this section, a “sanitary survey,” as conducted by the Division, includes but is not limited to, an onsite review of the water source(s) (identifying sources of contamination by using results of source water assessments or other relevant information where available), facilities, equipment, operation, maintenance, and monitoring compliance of a public water system to evaluate the adequacy of the system, its sources and operations and the distribution of safe drinking water.

8.2.3 The sanitary survey must include an evaluation of the applicable components listed in subsections 8.2.3.1 through 8.2.3.8:

8.2.3.1 Source;

8.2.3.2 Treatment;

8.2.3.3 Distribution system;

8.2.3.4 Finished water system;

8.2.3.5 Pumps, pump facilities, and controls;

8.2.3.6 Monitoring, reporting, and data verification;

8.2.3.7 System management and operation; and

8.2.3.8 Operator compliance with Division requirements.

8.3 Ground water source microbial monitoring and analytical methods.

8.3.1 Triggered source water monitoring.

8.3.1.1 General requirements. A ground water system must conduct triggered source water monitoring if the conditions identified in subsections 8.3.1.1.1, 8.3.1.1.2 and 8.3.1.1.3 exist.

8.3.1.1.1 The system does not provide at least 4-log treatment of viruses (using inactivation, removal, or a Division-approved combination of 4-log virus inactivation and removal) before or at the first customer for each ground water source; and

8.3.1.1.2 The system is notified that a sample collected under subsection 7.1 is total coliform-positive and the sample is not invalidated under subsection 7.2.2 until December 31, 2015.

8.3.1.1.3 The system is notified that a sample collected under subsection 7.4.7 is total coliform-positive and the sample is not invalidated under subsection 7.4.3.3 beginning January 1, 2016.

8.3.1.2 Sampling Requirements. A ground water system must collect, within 24 hours of notification of the total coliform-positive sample, at least one ground water source sample from each ground water source in use at the time the total coliform-positive sample was collected under subsection 7.1 until December 31, 2015, or collected under subsections 7.4.4 through 7.4.7 beginning January 1, 2016 except as provided in subsection 8.3.1.2.2.

8.3.1.2.1 The Division may extend the 24-hour time limit on a case-by-case basis if the system cannot collect the ground water source water sample within 24 hours due to circumstances beyond its control. In the case of an extension, the Division must specify how much time the system has to collect the sample.

8.3.1.2.2 If approved by the Division, systems with more than one ground water source may meet the requirements of subsection 8.3.1.2 by sampling a representative ground water source or sources. If directed by the Division, systems must submit for Division approval a triggered source water monitoring plan that identifies one or more ground water sources that are representative of each monitoring site in the system's sample siting plan under subsection 7.1 until December 31, 2015, or under subsection 7.4.3 beginning January 1, 2016 and that the system intends to use for representative sampling under this paragraph.

8.3.1.2.3 Until December 31, 2015 a ground water system serving 1,000 people or fewer may use a repeat sample collected from a ground water source to meet both the requirements of subsection 7.2.3 and to satisfy the monitoring requirements of subsection 8.3.1.2 for that ground water source only if the Division approves the use of E. coli as a fecal indicator for source water monitoring under subsection 8.3.1. If the repeat sample collected from the ground water source is E. coli-positive, the system must comply with subsection 8.3.1.3.

8.3.1.2.4 Beginning January 1, 2016 a ground water system serving 1,000 or fewer people may use a repeat sample collected from a ground water source to meet both the requirements of subsection 7.4 and to satisfy the monitoring requirements of subsection 8.3.1.2 for that ground water source only if the Division approves the use of E. coli as a fecal indicator for source water monitoring under subsection 8.3.1 and approves the use of a single sample for meeting both the triggered source water monitoring requirements in subsection 8.3.1 and the repeat monitoring requirements in subsection 7.4.8. If the repeat sample collected from the ground water source is E. coli-positive, the system must comply with subsection 8.3.1.3.

8.3.1.3 Additional Requirements. If the Division does not require corrective action under subsection 8.4.1.2 for a fecal indicator-positive source water sample collected under subsection 8.3.1.2 that is not invalidated under subsection 8.3.4, the system must collect five additional source water samples from the same source within 24 hours of being notified of the fecal indicator-positive sample.

8.3.1.4 Consecutive and Wholesale Systems.

8.3.1.4.1 In addition to the other requirements of subsection 8.3.1, a consecutive ground water system that has a total coliform-positive sample collected under subsection 7.1 until December 31, 2015 or under subsections 7.4.4 through 7.4.7 beginning January 1, 2016 must notify the wholesale system(s) within 24 hours of being notified of the total coliform-positive sample.

8.3.1.4.2 In addition to the other requirements of subsection 8.3.1, a wholesale ground water system must comply with subsections 8.3.1.4.2.1 and 8.3.1.4.2.2.

8.3.1.4.2.1 A wholesale ground water system that receives notice from a consecutive system it serves that a sample collected under subsection 7.11 until December 31, 2015 or under subsections 7.4.4 through 7.4.7 beginning January 1, 2016 is total coliform-positive must, within 24 hours of being notified, collect a sample from its ground water source(s) under subsection 8.3.1.2 and analyze it for a fecal indicator under subsection 8.3.3.

8.3.1.4.2.2 If the sample collected under subsection 8.3.1.4.2.1 is fecal indicator-positive, the wholesale ground water system must notify all consecutive systems served by that ground water source of the fecal indicator source water positive within 24 hours of being notified of the ground water source sample monitoring result and must meet the requirements of subsection 8.3.1.3.

8.3.1.5 Exceptions to the Triggered Source Water Monitoring Requirements. A ground water system is not required to comply with the source water monitoring requirements of subsection 8.3.1 if either of the following conditions exists:

8.3.1.5.1 The Division determines, and documents in writing, that the total coliform-positive sample collected under subsection 7.1 1 until December 31, 2015 or under subsections 7.4.4 through 7.4.7 beginning January 1, 2016 is caused by a distribution system deficiency; or

8.3.1.5.2 The total coliform-positive sample collected under subsection 7.1 1 until December 31, 2015 or under subsections 7.4.4 through 7.4.7 beginning January 1, 2016 is collected at a location that meets Division criteria for distribution system conditions that will cause total coliform-positive samples.

8.3.2 Assessment Source Water Monitoring. If directed by the Division, ground water systems must conduct assessment source water monitoring that meets Division-determined requirements for such monitoring. A ground water system conducting assessment source water monitoring may use a triggered source water sample collected under subsection 8.3.1.2 to meet the requirements of subsection 8.3.2. Division-determined assessment source water monitoring requirements may include:

8.3.2.1 Collection of a total of 12 ground water source samples that represent each month the system provides ground water to the public;

8.3.2.2 Collection of samples from each well unless the system obtains written Division approval to conduct monitoring at one or more wells within the ground water system that are representative of multiple wells used by that system and that draw water from the same hydrogeologic setting;

8.3.2.3 Collection of a standard sample volume of at least 100 mL for fecal indicator analysis regardless of the fecal indicator or analytical method used;

8.3.2.4 Analysis of all ground water source samples using one of the analytical methods listed in subsection 8.3.3.2 for the presence of E. coli, enterococci, or coliphage;

8.3.2.5 Collection of ground water source samples at a location prior to any treatment of the ground water source unless the Division approves a sampling location after treatment; and

8.3.2.6 Collection of ground water source samples at the well itself unless the system's configuration does not allow for sampling at the well itself and the Division approves an alternate sampling location that is representative of the water quality of that well.

8.3.3 Analytical methods.

8.3.3.1 A ground water system subject to the source water monitoring requirements of subsection 8.3.1 must collect a standard sample volume of at least 100 mL for fecal indicator analysis regardless of the fecal indicator or analytical method used.

8.3.3.2 A ground water system must analyze all ground water source samples collected under subsection 8.3.1 using one of the analytical methods listed in the following table for the presence of E. coli, enterococci, or coliphage:

Analytical Methods for Source Water Monitoring

Analyses must be conducted in accordance with the documents listed below. The Director of the Federal Register approves the incorporation by reference of the documents listed in footnotes 2-11 in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of the documents may be obtained from the sources listed below. Copies may be inspected at EPA's Drinking Water Docket, EPA West, 1301 Constitution Avenue, NW., EPA West, Room B102, Washington DC 20460 (Telephone: 202-566-2426); or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741- 6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

8.3.4 Invalidation of a fecal indicator-positive ground water source sample.

8.3.4.1 A ground water system may obtain Division invalidation of a fecal indicator-positive ground water source sample collected under subsection 8.3.1 only under the conditions specified in subsections 8.3.4.1.1 and 8.3.4.1.2.

8.3.4.1.1 The system provides the Division with written notice from the laboratory that improper sample analysis occurred; or

8.3.4.1.2 The Division determines and documents in writing that there is substantial evidence that a fecal indicator-positive ground water source sample is not related to source water quality.

8.3.4.2 If the Division invalidates a fecal indicator-positive ground water source sample, the ground water system must collect another source water sample under subsection 8.3.1 within 24 hours of being notified by the Division of its invalidation decision and have it analyzed for the same fecal indicator using the analytical methods in subsection 8.3.3. The Division may extend the 24-hour time limit on a case-by-case basis if the system cannot collect the source water sample within 24 hours due to circumstances beyond its control. In the case of an extension, the Division must specify how much time the system has to collect the sample.

8.3.5 Sampling location.

8.3.5.1 Any ground water source sample required under subsection 8.3.1 must be collected at a location prior to any treatment of the ground water source unless the Division approves a sampling location after treatment.

8.3.5.2 If the system's configuration does not allow for sampling at the well itself, the system may collect a sample at a Division-approved location to meet the requirements of subsection 8.3.1 if the sample is representative of the water quality of that well.

8.3.6 New Sources. If directed by the Division, a ground water system that places a new ground water source into service after November 30, 2009, must conduct assessment source water monitoring under subsection 8.3.2. If directed by the Division, the system must begin monitoring before the ground water source is used to provide water to the public.

8.3.7 Public Notification. A ground water system with a ground water source sample collected under subsections 8.3.1 or 8.3.2 that is fecal indicator-positive and that is not invalidated under subsection 8.3.4, including consecutive systems served by the ground water source, must conduct public notification under subsection 4.2.1.1.1.

8.3.8 Monitoring Violations. Failure to meet the requirements of subsections 8.3.1 through 8.3.6 is a monitoring violation and requires the ground water system to provide public notification under subsection 4.2.1.1.3.

8.4 Treatment technique requirements for ground water systems.

8.4.1 Ground water systems with significant deficiencies or source water fecal contamination.

8.4.1.1 The treatment technique requirements of this section must be met by ground water systems when a significant deficiency is identified or when a ground water source sample collected under subsection 8.3.1.3 is fecal indicator-positive.

8.4.1.2 If directed by the Division, a ground water system with a ground water source sample collected under subsection 8.3.1.2, subsection 8.3.1.4, or subsection 8.3.2 that is fecal indicator-positive must comply with the treatment technique requirements of this subsection.

8.4.1.3 When a significant deficiency is identified at a Subpart H public water system that uses both ground water and surface water or ground water under the direct influence of surface water, the system must comply with provisions of subsection 8.4 except in cases where the Division determines that the significant deficiency is in a portion of the distribution system that is served solely by surface water or ground water under the direct influence of surface water.

8.4.1.4 Unless the Division directs the ground water system to implement a specific corrective action, the ground water system must consult with the Division regarding the appropriate corrective action within 30 days of receiving written notice from the Division of a significant deficiency, written notice from a laboratory that a ground water source sample collected under subsection 8.3.1.3 was found to be fecal indicator-positive, or direction from the Division that a fecal indicator-positive collected under subsection 8.3.1.2, subsection 8.3.1.4, or subsection 8.3.2 requires corrective action. For the purposes of this section, significant deficiencies include, but are not limited to, defects in design, operation, or maintenance, or a failure or malfunction of the sources, treatment, storage, or distribution system that the Division determines to be causing, or have potential for causing, the introduction of contamination into the water delivered to consumers.

8.4.1.5 Within 120 days (or earlier if directed by the Division) of receiving written notification from the Division of a significant deficiency, written notice from a laboratory that a ground water source sample collected under subsection 8.3.1.3 was found to be fecal indicator-positive, or direction from the Division that a fecal indicator-positive sample collected under subsection 8.3.1.2, subsection 8.3.1.4, or subsection 8.3.2 requires corrective action, the ground water system must either:

8.4.1.5.1 Have completed corrective action in accordance with applicable Division plan review processes or other Division guidance or direction, if any, including Division-specified interim measures; or

8.4.1.5.2 Be in compliance with a Division-approved corrective action plan and schedule subject to the conditions specified in subsections 8.4.1.5.2.1 and 8.4.1.5.2.2.

8.4.1.5.2.1 Any subsequent modifications to a Division-approved corrective action plan and schedule must also be approved by the Division.

8.4.1.5.2.2 If the Division specifies interim measures for protection of the public health pending Division approval of the corrective action plan and schedule or pending completion of the corrective action plan, the system must comply with these interim measures as well as with any schedule specified by the Division.

8.4.1.6 Corrective Action Alternatives. Ground water systems that meet the conditions of subsections 8.4.1.1 or 8.4.1.2 must implement one or more of the following corrective action alternatives:

8.4.1.6.1 Correct all significant deficiencies;

8.4.1.6.2 Provide an alternate source of water;

8.4.1.6.3 Eliminate the source of contamination; or

8.4.1.6.4 Provide treatment that reliably achieves at least 4-log treatment of viruses (using inactivation, removal, or a Division-approved combination of 4-log virus inactivation and removal) before or at the first customer for the ground water source.

8.4.1.7 Special notice to the public of significant deficiencies or source water fecal contamination.

8.4.1.7.1 In addition to the applicable public notification requirements of subsection 4.2.1.1.1, a community ground water system that receives notice from the Division of a significant deficiency or notification of a fecal indicator-positive ground water source sample that is not invalidated by the Division under subsection 8.3.4 must inform the public served by the water system under subsection 4.3.3.8.6 of the fecal indicator-positive source sample or of any significant deficiency that has not been corrected. The system must continue to inform the public annually until the significant deficiency is corrected or the fecal contamination in the ground water source is determined by the Division to be corrected under subsection 8.4.1.5.

8.4.1.7.2 In addition to the applicable public notification requirements of subsection 4.2.1.1.1, a non-community ground water system that receives notice from the Division of a significant deficiency must inform the public served by the water system in a manner approved by the Division of any significant deficiency that has not been corrected within 12 months of being notified by the Division, or earlier if directed by the Division. The system must continue to inform the public annually until the significant deficiency is corrected. The information must include:

8.4.1.7.2.1 The nature of the significant deficiency and the date the significant deficiency was identified by the Division;

8.4.1.7.2.2 The Division-approved plan and schedule for correction of the significant deficiency, including interim measures, progress to date, and any interim measures completed; and

8.4.1.7.2.3 For systems with a large proportion of non-English speaking consumers, as determined by the Division, information in the appropriate language(s) regarding the importance of the notice or a telephone number or address where consumers may contact the system to obtain a translated copy of the notice or assistance in the appropriate language.

8.4.1.7.3 If directed by the Division, a non-community water system with significant deficiencies that have been corrected must inform its customers of the significant deficiencies, how the deficiencies were corrected, and the dates of correction under subsection 8.4.1.7.2.

8.4.2 Compliance monitoring

8.4.2.1 Existing ground water sources. A ground water system that is not required to meet the source water monitoring requirements of this subsection for any ground water source because it provides at least 4-log treatment of viruses (using inactivation, removal, or a Division-approved combination of 4-log virus inactivation and removal) before or at the first customer for any ground water source before December 1, 2009, must notify the Division in writing that it provides at least 4-log treatment of viruses (using inactivation, removal, or a Division-approved combination of 4-log virus inactivation and removal) before or at the first customer for the specified ground water source and begin compliance monitoring in accordance with subsection 8.4.2.3 by December 1, 2009. Notification to the Division must include engineering, operational, or other information that the Division requests to evaluate the submission. If the system subsequently discontinues 4-log treatment of viruses (using inactivation, removal, or a Division-approved combination of 4-log virus inactivation and removal) before or at the first customer for a ground water source, the system must conduct ground water source monitoring as required under subsection 8.3.

8.4.2.2 New ground water sources. A ground water system that places a ground water source in service after November 30, 2009, that is not required to meet the source water monitoring requirements of this subsection because the system provides at least 4-log treatment of viruses (using inactivation, removal, or a Division-approved combination of 4-log virus inactivation and removal) before or at the first customer for the ground water source must comply with the requirements of subsections 8.4.2.2.1, 8.4.2.2.2 and 8.4.2.2.3.

8.4.2.2.1 The system must notify the Division in writing that it provides at least 4-log treatment of viruses (using inactivation, removal, or a Division-approved combination of 4-log virus inactivation and removal) before or at the first customer for the ground water source. Notification to the Division must include engineering, operational, or other information that the division requests to evaluate the submission.

8.4.2.2.2 The system must conduct compliance monitoring as required under subsection 8.4.2.3 within 30 days of placing the source in service.

8.4.2.2.3 The system must conduct ground water source monitoring under subsection 8.3 if the system subsequently discontinues 4-log treatment of viruses (using inactivation, removal, or a Division-approved combination of 4-log virus inactivation and removal) before or at the first customer for the ground water source.

8.4.2.3 Monitoring requirements. A ground water system subject to the requirements of subsections 8.4.2.1, 8.4.2.2.1 or 8.4.2.2.2 must monitor the effectiveness and reliability of treatment for that ground water source before or at the first customer as follows:

8.4.2.3.1 Chemical disinfection

8.4.2.3.1.1 Ground water systems serving greater than 3,300 people. A ground water system that serves greater than 3,300 people must continuously monitor the residual disinfectant concentration using analytical methods specified in subsection 1.19.2 at a location approved by the Division and must record the lowest residual disinfectant concentration each day that water from the ground water source is served to the public. The ground water system must maintain the Division-determined residual disinfectant concentration every day the ground water system serves water from the ground water source to the public. If there is a failure in the continuous monitoring equipment, the ground water system must conduct grab sampling every four hours until the continuous monitoring equipment is returned to service. The system must resume continuous residual disinfectant monitoring within 14 days.

8.4.2.3.1.2 Ground water systems serving 3,300 or fewer people. A ground water system that serves 3,300 or fewer people must monitor the residual disinfectant concentration using analytical methods specified in subsection 1.19.2 at a location approved by the Division and record the residual disinfection concentration each day that water from the ground water source is served to the public. The ground water system must maintain the Division-determined residual disinfectant concentration every day the ground water system serves water from the ground water source to the public. The ground water system must take a daily grab sample during the hour of peak flow or at another time specified by the Division. If any daily grab sample measurement falls below the Division-determined residual disinfectant concentration, the ground water system must take follow-up samples every four hours until the residual disinfectant concentration is restored to the Division-determined level. Alternatively, a ground water system that serves 3,300 or fewer people may monitor continuously and meet the requirements of subsection 8.4.2.3.1.1.

8.4.2.3.2 Membrane filtration. A ground water system that uses membrane filtration to meet the requirements of this section must monitor the membrane filtration process in accordance with all Division-specified monitoring requirements and must operate the membrane filtration in accordance with all Division-specified compliance requirements. A ground water system that uses membrane filtration is in compliance with the requirement to achieve at least 4-log removal of viruses when:

8.4.2.3.2.1 The membrane has an absolute molecular weight cut-off (MWCO), or an alternate parameter that describes the exclusion characteristics of the membrane, that can reliably achieve at least 4-log removal of viruses;

8.4.2.3.2.2 The membrane process is operated in accordance with Division-specified compliance requirements; and

8.4.2.3.2.3 The integrity of the membrane is intact.

8.4.2.3.3 Alternative treatment. A ground water system that uses a Division-approved alternative treatment to meet the requirements of this section by providing at least 4-log treatment of viruses (using inactivation, removal, or a Division-approved combination of 4-log virus inactivation and removal) before or at the first customer must:

8.4.2.3.3.1 Monitor the alternative treatment in accordance with all Division-specified monitoring requirements; and

8.4.2.3.3.2 Operate the alternative treatment in accordance with all compliance requirements that the Division determines to be necessary to achieve at least 4-log treatment of viruses.

8.4.3 Discontinuing treatment. A ground water system may discontinue 4-log treatment of viruses (using inactivation, removal, or a Division-approved combination of 4-log virus inactivation and removal) before or at the first customer for a ground water source if the Division determines and documents in writing that 4-log treatment of viruses is no longer necessary for that ground water source. A system that discontinues 4-log treatment of viruses is subject to the source water monitoring and analytical methods requirements of subsection 8.3.

8.4.4 Failure to meet the monitoring requirements of subsection 8.4.2.1 is a monitoring violation and requires the ground water system to provide public notification under subsection 4.2.1.1.3.

8.5 Treatment technique violations for ground water systems.

8.5.1 A ground water system with a significant deficiency is in violation of the treatment technique requirement if, within 120 days (or earlier if directed by the Division) of receiving written notice from the Division of the significant deficiency, the system:

8.5.1.1 Does not complete corrective action in accordance with any applicable Division plan review processes or other Division guidance and direction, including Division specified interim actions and measures; or

8.5.1.2 Is not in compliance with a Division-approved corrective action plan and schedule.

8.5.2 Unless the Division invalidates a fecal indicator-positive ground water source sample under subsection 8.3.4, a ground water system is in violation of the treatment technique requirement if, within 120 days (or earlier if directed by the Division) of meeting the conditions of subsection 8.4.1.1 or subsection 8.4.1.2, the system:

8.5.2.1 Does not complete corrective action in accordance with any applicable Division plan review processes or other Division guidance and direction, including Division-specified interim measures; or

8.5.2.2 Is not in compliance with a Division-approved corrective action plan and schedule.

8.5.3 A ground water system subject to the requirements of subsection 8.4.2.3 that fails to maintain at least 4-log treatment of viruses (using inactivation, removal, or a Division-approved combination of 4-log virus inactivation and removal) before or at the first customer for a ground water source is in violation of the treatment technique requirement if the failure is not corrected within four hours of determining the system is not maintaining at least 4-log treatment of viruses before or at the first customer.

8.5.4 Ground water system must give public notification under subsection 4.2.1.1.2 for the treatment technique violations specified in subsections 8.5.1, 8.5.2 and 8.5.3.

8.6 Reporting and recordkeeping for ground water systems.

8.6.1 Reporting. In addition to the requirements of subsection 4.1, a ground water system regulated under this section must provide the following information to the Division:

8.6.1.1 A ground water system conducting compliance monitoring under subsection 8.4.2 must notify the Division any time the system fails to meet any Division-specified requirements including, but not limited to, minimum residual disinfectant concentration, membrane operating criteria or membrane integrity, and alternative treatment operating criteria, if operation in accordance with the criteria or requirements is not restored within four hours. The ground water system must notify the Division as soon as possible, but in no case later than the end of the next business day.

8.6.1.2 After completing any corrective action under subsection 8.4.1, a ground water system must notify the Division within 30 days of completion of the corrective action.

8.6.1.3 If a ground water system subject to the requirements of subsection 8.3.1 does not conduct source water monitoring under subsection 8.3.1.5.3, the system must provide documentation to the Division within 30 days of the total coliform positive sample that it met the Division criteria.

8.6.2 Recordkeeping. In addition to the requirements of Section 5.0, a ground water system regulated under this section must maintain the following information in its records:

8.6.2.1 Documentation of corrective actions. Documentation shall be kept for a period of not less than ten years.

8.6.2.2 Documentation of notice to the public as required under subsection 8.4.1.7. Documentation shall be kept for a period of not less than three years.

8.6.2.3 Records of decisions under subsection 8.3.1.5.2 and records of invalidation of fecal indicator-positive ground water source samples under subsection 8.3.4. Documentation shall be kept for a period of not less than five years.

8.6.2.4 For consecutive systems, documentation of notification to the wholesale system(s) of total-coliform positive samples that are not invalidated under subsection 7.2.2 until December 31, 2015, or under subsection 7.4.3. Documentation shall be kept for a period of not less than five years.

8.6.2.5 For systems, including wholesale systems, that are required to perform compliance monitoring under subsection 8.4.2:

8.6.2.5.1 Records of the Division-specified minimum disinfectant residual. Documentation shall be kept for a period of not less than ten years.

8.6.2.5.2 Records of the lowest daily residual disinfectant concentration and records of the date and duration of any failure to maintain the Division-prescribed minimum residual disinfectant concentration for a period of more than four hours. Documentation shall be kept for a period of not less than five years.

8.6.2.5.3 Records of Division-specified compliance requirements for membrane filtration and of parameters specified by the Division for Division-approved alternative treatment and records of the date and duration of any failure to meet the membrane operating, membrane integrity, or alternative treatment operating requirements for more than four hours. Documentation shall be kept for a period of not less than five years.

**History**
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *25 DE Reg. 713 (01/01/22)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *5 DE Reg. 2121 (05/01/02)*
- *9 DE Reg. 999 (12/01/05)*
- *15 DE Reg. 73 (07/01/12)*
- *17 DE Reg. 439 (10/01/13)*
- *19 DE Reg. 517 (12/01/15)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *25 DE Reg. 713 (01/01/22)*

##### **16 Del. Admin. Code § 4462-9.0** Inorganic and Organic Chemical Requirements {#sec-4462-9.0 omnilex-key=us-de-regs-official--title-16--4462-9.0}

9.1 Inorganic Chemical Requirements

9.1.1 PMCLs AND SMCLs: The following are the inorganic PMCLs and SMCLs (mg/L - milligrams per liter). Compliance is determined pursuant to subsection 9.1.2 through 9.1.13.

9.1.1.1 Table of PMCLs

*MFL - million fibers per liter, with fiber length > 10 microns

9.1.1.2 Table of SMCLs

9.1.1.3 Table for Lead/Copper MCLGs: The Maximum Contaminant Level Goals (MCLG) for lead and copper are as follows:

Lead

**History**
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *25 DE Reg. 713 (01/01/22)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *5 DE Reg. 2121 (05/01/02)*
- *9 DE Reg. 999 (12/01/05)*
- *15 DE Reg. 73 (07/01/12)*
- *17 DE Reg. 439 (10/01/13)*
- *19 DE Reg. 517 (12/01/15)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *25 DE Reg. 713 (01/01/22)*

##### **16 Del. Admin. Code § 4462-0** mg/L {#sec-4462-0 omnilex-key=us-de-regs-official--title-16--4462-0}

Copper

**History**
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *25 DE Reg. 713 (01/01/22)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *5 DE Reg. 2121 (05/01/02)*
- *9 DE Reg. 999 (12/01/05)*
- *15 DE Reg. 73 (07/01/12)*
- *17 DE Reg. 439 (10/01/13)*
- *19 DE Reg. 517 (12/01/15)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *25 DE Reg. 713 (01/01/22)*

##### **16 Del. Admin. Code § 4462-1.3** mg/L {#sec-4462-1.3 omnilex-key=us-de-regs-official--title-16--4462-1.3}

9.1.2 Sampling and Analytical Requirements:

9.1.2.1 Community water systems shall conduct monitoring to determine compliance with the maximum contaminant levels specified in subsection 9.1.1 in accordance with subsections 9.1.3 through 9.1.13. Non-transient, non-community water systems shall conduct monitoring to determine compliance with the maximum contaminant levels specified in subsection 9.1.1 in accordance with subsections 9.1.3 through 9.1.13. Transient, non-community water systems shall conduct monitoring to determine compliance with the nitrate and nitrite maximum contaminant levels in subsection 9.1.1 in accordance with subsections 9.1.3 through 9.1.13.

9.1.2.2 Detection limits for each analytical method shall be in accordance with 40 CFR 141.23(a)(4)(i) as amended. Copies may be obtained from the Office of Drinking Water.

9.1.3 Monitoring shall be conducted as follows:

9.1.3.1 Groundwater systems shall take a minimum of one sample at every entry point to the distribution system which is representative of each well after treatment [hereafter called a sampling point] beginning in the compliance period starting January 1, 1993. The system shall take each sample at the same sampling point unless conditions make another sampling point more representative of each source or treatment plant.

9.1.3.1.1 Groundwater systems with 150 or more service connections shall begin monitoring for Phase II and Phase V contaminants on January 1, 1993.

9.1.3.1.2 Groundwater systems with less than 150 service connections shall begin monitoring for Phase II contaminants on January 1, 1993 and for Phase V contaminants on January 1, 1996.

9.1.3.2 Surface water systems shall take a minimum of one sample at every entry point to the distribution system after any application of treatment or in the distribution system at a point which is representative of each source after treatment [hereafter called a sampling point] beginning in the compliance period beginning January 1, 1993. The system shall take each sample at the same sampling point unless conditions make another sampling point more representative of each source or treatment plant.

NOTE: For purposes of this paragraph, surface water systems include systems with a combination of surface and ground sources.

9.1.3.2.1 Surface water systems with 150 or more service connections shall begin monitoring for Phase II and Phase V contaminants on January 1, 1993.

9.1.3.2.2 Surface water systems with less than 150 service connections shall begin monitoring for Phase II contaminants on January 1, 1993 and for Phase V contaminants on January 1, 1996.

9.1.3.3 If a system draws water from more than one source and the sources are combined before distribution, the system must sample at an entry point to the distribution system during periods of normal operating conditions (i.e., when water is representative of all sources being used).

9.1.3.4 The Division may reduce the total number of samples which must be analyzed by allowing the use of compositing. Composite samples from a maximum of five sampling points are allowed provided that the detection limit of the method used for analysis is less than one-fifth of the MCL. Compositing of samples must be done in the laboratory.

9.1.3.4.1 If the concentration in the composite sample is greater than or equal to one-fifth of the MCL of any inorganic chemical, then a follow-up sample must be taken within 14 days at each sampling point included in the composite. These samples must be analyzed for the contaminants which exceeded one-fifth of the MCL in the composite sample.

9.1.3.4.2 If the population served by the system is >3,300 persons, then compositing may only be permitted by the Division at sampling points within a single system. In systems serving ≤3,300 persons, the Division may permit compositing among different systems provided the 5-sample limit is maintained.

9.1.3.4.3 If duplicates of the original sample taken from each sampling point used in the composite are available, the system may use these instead of resampling. The duplicates must be analyzed and the results reported to the Division within 14 days of collection

9.1.3.5 The frequency of monitoring for asbestos shall be in accordance with subsection 9.1.4; the frequency of monitoring for antimony, arsenic, barium, beryllium, cadmium, chromium, cyanide, fluoride, mercury, nickel, selenium and thallium shall be in accordance with subsection 9.1.5; the frequency of monitoring for nitrate shall be in accordance with subsection 9.1.6; and the frequency of monitoring for nitrite shall be in accordance with subsection 9.1.7.

9.1.4 The frequency of monitoring conducted to determine compliance with the maximum contaminant level for asbestos specified in subsection 9.1.1 shall be conducted as follows:

9.1.4.1 Each community and non-transient, non-community water system is required to monitor for asbestos during the first three-year compliance period of each nine-year compliance cycle beginning in the compliance period starting January 1, 1993.

9.1.4.2 If the system believes it is not vulnerable to either asbestos contamination in its source water or due to corrosion of asbestos-cement pipe, or both, it may apply to the Division for a waiver of the monitoring requirement in subsection 9.1.4.1. If the Division grants the waiver, the system is not required to monitor.

9.1.4.3 The Division may grant a waiver based on a consideration of the following factors:

9.1.4.3.1 Potential asbestos contamination of the water source, and

9.1.4.3.2 The use of asbestos-cement pipe for finished water distribution and the corrosive nature of the water.

9.1.4.4 A waiver remains in effect until the completion of the three-year compliance period. Systems not receiving a waiver must monitor in accordance with the provisions of subsection 9.1.4.1.

9.1.4.5 A system vulnerable to asbestos contamination due solely to corrosion of asbestos-cement pipe shall take one sample at a tap served by asbestos-cement pipe and under conditions where asbestos contamination is most likely to occur.

9.1.4.6 A system vulnerable to asbestos contamination due solely to source water shall monitor in accordance with the provision of subsection 9.1.3.

9.1.4.7 A system vulnerable to asbestos contamination due both to its source water supply and corrosion of asbestos-cement pipe shall take one sample at each entry point after treatment and a minimum of one tap sample served by asbestos-cement pipe and under conditions where asbestos contamination is most likely to occur.

9.1.4.8 A system which exceeds PMCL listed in subsection 9.1.1 shall monitor quarterly beginning in the next quarter after the violation occurred.

9.1.4.9 The Division may decrease the quarterly monitoring requirement to the frequency specified in subsection 9.1.4.1 provided the Division has determined that the system is reliably and consistently below the maximum contaminant level. In no case can a Division make this determination unless a groundwater system takes a minimum of two quarterly samples and a surface (or combined surface/ground) water system takes a minimum of four quarterly samples.

9.1.4.10 If monitoring data collected after January 1, 1990 are generally consistent with the requirements of this section then the Division may allow systems to use that data to satisfy the monitoring requirement for the initial compliance period beginning January 1, 1993.

9.1.5 The frequency of monitoring conducted to determine compliance with the maximum contaminant levels in subsection 9.1.1 for antimony, arsenic, barium, beryllium, cadmium, chromium, cyanide, fluoride, mercury, nickel, selenium and thallium shall be as follows:

9.1.5.1 Groundwater systems shall take one sample at each sampling point once every three (3) years. Surface Water systems [or combined surface/ground] shall take one sample annually at each sampling point beginning January 1, 1993.

9.1.5.2 The system may apply to the Division for a waiver from the monitoring frequencies specified in subsection 9.1.5.1.

9.1.5.3 A condition of the waiver shall require that a system shall take a minimum of one sample while the waiver is effective. The term during which the waiver is effective shall not exceed one compliance cycle (i.e., nine years).

9.1.5.4 The Division may grant a waiver provided surface water systems have monitored annually for at least three years and groundwater systems have conducted a minimum of three rounds of monitoring. (At least one sample shall have been taken since January 1, 1990.) Both surface and groundwater systems shall demonstrate that all previous analytical results were less than the maximum contaminant level. Systems that use a new water source are not eligible for a waiver until three rounds of monitoring from the new source have been completed.

9.1.5.5 In determining the appropriate reduced monitoring frequency, the Division shall consider:

9.1.5.5.1 Reported concentrations from all previous monitoring;

9.1.5.5.2 The degree of variation in reported concentrations; and

9.1.5.5.3 Other factors which may affect contaminant concentrations such as changes in groundwater pumping rates, changes in the systems configuration, changes in the system’s operating procedures, or changes in stream flows or characteristics.

9.1.5.6 A decision by the Division to grant a waiver shall be made in writing and shall set forth the basis for the determination. The determination may be initiated by the Division or upon an application by the public water system. The public water system shall specify the basis for its request. The Division shall review and, where appropriate, revise its determination of the appropriate monitoring frequency when the system submits new monitoring data or when other data relevant to the system’s appropriate monitoring frequency become available.

9.1.5.7 Systems which exceed the MCLs as calculated in subsection 9.1.11 shall monitor quarterly beginning in the next quarter after the violation occurred.

9.1.5.8 The Division may decrease the quarterly monitoring requirement to the frequencies specified in subsections 9.1.5.1 and 9.1.5.2 provided it has determined that the system is reliably and consistently below the maximum contaminant level. In no case can the Division make this determination unless a groundwater system takes a minimum of two quarterly samples and a surface water system takes a minimum of four quarterly samples.

9.1.5.9 All new systems that use a new source of water or existing systems that add a new source of water that begin operation after January 22, 2004 must demonstrate compliance with the MCL within a period of time specified by the Division. The system must also comply with the initial sampling frequencies specified by the Division to ensure a system can demonstrate compliance with the MCL. Routine and increased monitoring frequencies shall be conducted in accordance with the requirements in this section.

9.1.6 All public water systems (community; non-transient, non-community; and transient, non-community systems) shall monitor to determine compliance with the maximum contaminant level for nitrate in subsection 9.1.1.

9.1.6.1 Community and non-transient, non-community water systems served by groundwater systems shall monitor annually and systems served by surface water shall monitor quarterly.

9.1.6.2 For community and non-transient, non-community water systems, the repeat monitoring frequency for groundwater systems shall be quarterly for at least one year following any one sample in which the concentration is ≥50 percent of the MCL. The Division may allow a groundwater system to reduce the sampling frequency to annually after four consecutive quarterly samples are reliably and consistently less than 85 percent of the MCL.

9.1.6.3 For community and non-transient, non-community water systems, the Division may allow a surface water system to reduce the sampling frequency to annually if all analytical results from four consecutive quarters are <50 percent of the MCL. A surface water system shall return to quarterly monitoring if any one sample is ≥50 percent of the MCL.

9.1.6.4 Each transient non-community water system shall monitor annually beginning January 1, 1993.

9.1.6.5 After the initial round of quarterly sampling is completed, each community and non-transient non-community system which is monitoring annually shall take subsequent samples during the quarter(s) which previously resulted in the highest analytical result.

9.1.7 All public water systems (community; non-transient, non-community; and transient, non-community systems) shall monitor to determine compliance with the maximum contaminant level for nitrite in subsection 9.1.1

9.1.7.1 All public water systems shall take one sample at each sampling point in the distribution system during the compliance period beginning January 1, 1993 and ending December 31, 1995.

9.1.7.2 After the initial sample, systems where an analytical result for nitrite is <50 percent of the MCL shall monitor at the frequency specified by the Division.

9.1.7.3 For community, non-transient, non-community, and transient non-community water systems, the repeat monitoring frequency for any water system shall be quarterly for at least one year following any one sample in which the concentration is ≥50 percent of the MCL. The Division may allow a system to reduce the sampling frequency to annually after determining the system is reliably and consistently less than the MCL.

9.1.7.4 Systems which are monitoring annually shall take each subsequent sample during the quarter(s) which previously resulted in the highest analytical result.

9.1.8 Confirmation Samples:

9.1.8.1 Where the results of sampling for antimony, arsenic, asbestos, barium, beryllium, cadmium, chromium, cyanide, fluoride, mercury, nickel, selenium, or thallium indicate an exceedance of the maximum contaminant level, the Division may require that one additional sample be collected, as soon as possible after the initial sample was taken (but not to exceed two weeks), at the same sampling point.

9.1.8.2 Where nitrate or nitrite sampling results indicate an exceedance of the maximum contaminant level, the system shall take a confirmation sample within 24 hours of the system’s receipt of notification of the analytical results of the first sample. Systems unable to comply with the 24-hour sampling requirement must immediately notify the consumers in the area served by the public water system in accordance with subsection 4.2. Systems exercising this option must take and analyze a confirmation sample within two weeks of notification of the analytical results of the first sample.

9.1.8.3 If a Division-required confirmation sample is taken for any contaminant, then the results of the initial and confirmation sample shall be averaged. The resulting average shall be used to determine the system’s compliance in accordance with subsection 9.1.11. The Division has the discretion to delete results of obvious sampling errors. Sampling errors include, but are not limited to samples collected from the wrong system or samples collected from private wells located within a public water system.

9.1.9 The Division may require more frequent monitoring than specified in subsections 9.1.4, 9.1.5, 9.1.6 and 9.1.7 or may require confirmation samples for positive and negative results at its discretion.

9.1.10 Systems may apply to the Division to conduct more frequent monitoring than the minimum monitoring frequencies specified in this section.

9.1.11 Compliance with subsection 9.1.1 shall be determined based on the analytical result(s) obtained at each sampling point:

9.1.11.1 For systems which are conducting monitoring at a frequency greater than annual, compliance with the maximum contaminant levels for antimony, arsenic, asbestos, barium, beryllium, cadmium, chromium, cyanide, fluoride, mercury, nickel, selenium, and thallium is determined by a running annual average at each sampling point. If the average at any sampling point is greater than the MCL, then the system is out of compliance. If any one sample would cause the annual average to be exceeded, then the system is out of compliance immediately. Any sample below the detection limit shall be calculated at zero for the purpose of determining the annual average. If a system fails to collect the required number of samples, compliance (average concentration) will be based on the total number of samples collected.

9.1.11.2 For systems which are monitoring annually, or less frequently, the system is out of compliance with the maximum contaminant levels for antimony, arsenic, asbestos, barium, beryllium, cadmium, chromium, cyanide, fluoride, mercury, nickel, selenium, and thallium if the level of a contaminant at any sampling point is greater than the MCL. If a confirmation sample is required by the Division, the determination of compliance will be based on the annual average of the initial MCL exceedance and any Division-required confirmation samples. If a system fails to collect the required number of samples, compliance (average concentration) will be based on the total number of samples collected.

9.1.11.3 Compliance with the maximum contaminant levels for nitrate and nitrite is determined based on one sample if the levels of these contaminants are below the MCLs. If the levels of nitrate and/or nitrite exceed the MCLs in the initial sample, a confirmation sample is required and compliance shall be determined based on the average of the initial and confirmation samples.

9.1.11.4 If a public water system has a distribution system separable from other parts of the distribution system with no interconnections, the Division may allow the system to give public notice to only the area served by that portion of the system which is out of compliance.

9.1.11.5 Arsenic sampling results will be reported to the nearest 0.001 mg/L.

9.1.12 Each public water system shall monitor at the time designated by the Division during each compliance period.

9.1.13 At the discretion of the Division, nitrate levels not to exceed 20 mg/L may be allowed in TNCWS and NTNCWS if the supplier of water demonstrates to the satisfaction of the Division that:

9.1.13.1 Such water will not be available to children under one (1) year of age;

9.1.13.2 There will be continuous posting of the fact that nitrate levels exceed ten (10) mg/L and the potential health effects of exposure and;

9.1.13.3 No adverse health effects shall result.

9.1.14 Fluoride (F):

9.1.14.1 Where fluoridation has been or will be instituted as required under 16 Del.C. §124, the target level for fluoride shall be 0.7 mg/L. An operational control range shall be maintained so that monthly average fluoride levels and 80% of daily fluoride measurements are between 0.6 mg/L and 1.0 mg/L. Fluoride levels shall not exceed 2.0 mg/L. Defluoridation of water shall be provided when the natural fluoride concentration exceeds 2.0 mg/L. In addition to the sampling and analysis required by subsection 9.1.5, fluoridated and defluoridated water supplies shall be sampled and analyzed daily by the supplier of water at a representative point(s) in the water supply system. In the event that the fluoride level exceeds 2.0 mg/L, samples shall be taken every two hours until the level returns to 2.0 mg/L or less. The exceedance shall be treated as a Tier 2 violation requiring public notification. If the fluoride level exceeds 4.0 mg/L a Tier 1 public notice is required. The fluoride levels shall be reported to the Division pursuant to subsection 4.1.1.

9.1.14.2 All municipal water supplies, whether municipally owned or privately owned, shall comply with subsection 9.1.14.1. All affected water supplies shall submit cost estimates to the Department of Health and Social Services no later than November 15, 1998.

9.1.15 Sodium (Na):

9.1.15.1 The supplier of water for a CWS shall collect and analyze one (1) sample per plant at the entry point of the distribution system for the determination of sodium concentration levels; samples must be collected and analyzed annually for systems utilizing surface water sources in whole or in part and at least every three (3) years for systems utilizing solely ground water sources. The minimum number of samples required to be taken by the system shall be based on the number of treatment plants used by the system, except that multiple wells drawing raw water from a single aquifer may, with Division approval be considered one (1) treatment plant for determining the minimum number of samples. The supplier of water may be required by the Division to collect and analyze water samples for sodium more frequently in locations where the sodium content is variable.

9.1.15.2 The supplier of water shall report to the Division the results of analyses for sodium pursuant to subsection 4.1.1.

9.1.15.3 The supplier of water shall notify appropriate local and State public health officials of the sodium levels by written notice by direct mail within three (3) months. A copy of each notice required to be provided by this paragraph shall be sent to the Division within ten (10) days of issuance. The supplier of water is not required to notify appropriate local public health officials of the sodium levels where the Division provides such notices in lieu of the supplier.

9.1.15.4 Analysis for sodium shall be performed in accordance with 40 CFR 141.23(k)(1) as amended. Copies may be obtained from the Office of Drinking Water.

9.1.16 Inorganic Compliance Determination:

9.1.16.1 Analysis for the purpose of determining compliance with subsection 9.1.1 shall be in accordance with the following:

9.1.16.1.1 PMCL analyses for all CWSs utilizing surface water sources shall be conducted annually. SMCL analyses shall be performed at the discretion of the Division.

9.1.16.1.2 PMCL analyses for all CWSs utilizing only ground water sources shall be conducted at three (3) year intervals. SMCL analyses shall be performed at the discretion of the Division.

9.1.16.1.3 For TNCWSs and NTNCWSs, whether supplied by surface or ground water sources, analyses for the purpose of determining compliance for nitrate shall be conducted at intervals determined by the Division.

9.1.16.1.4 The Division has the authority to determine compliance or initiate enforcement action based upon analytical results and other information compiled by its sanctioned representatives and agencies.

9.1.16.2 The provision of subsections 9.1.6 and 9.1.7 notwithstanding compliance with the PMCL for nitrate shall be determined on the basis of the mean of two (2) analyses. When a level exceeding the PMCL for nitrate is found, a second analysis shall be initiated within twenty-four (24) hours, and if the mean of the two (2) analyses exceeds the PMCL, the supplier of water shall report his findings to the Division pursuant to subsection 4.1 and shall notify the public pursuant to subsection 4.2.

9.1.16.3 For the initial analyses required by subsections 9.1.16.1, 9.1.16.2 and 9.1.16.3, data for surface waters acquired within one (1) year prior to the effective date and data for ground waters acquired within three (3) years prior to the effective date of this section may be substituted at the discretion of the Division.

9.1.17 Analytical Methodology:

9.1.17.1 Analyses conducted to determine compliance with subsection 9.1.1 for inorganic chemicals shall be made in accordance with the following methods.

9.1.17.1.1 PMCLs shall be in accordance with 40 CFR 141.23(k)(1) as amended. Copies may be obtained from the Office of Drinking Water.

9.1.17.1.2 SMCLs shall be accordance with 40 CFR section 143.4 as amended. Copies may be obtained from the Office of Drinking Water.

9.1.17.1.3 Sample Collection and Preservation: - Sample collection for antimony, arsenic, asbestos, barium, beryllium, cadmium, chromium, cyanide, fluoride, mercury, nickel, nitrate, nitrite, selenium and thallium under this section shall be conducted using the sample preservation method(s), container, and maximum holding time procedures in accordance with 40 CFR 141.23(k)(2) as amended. Copies may be obtained from the Office of Drinking Water.

9.1.17.1.4 Lab Approval: Analysis under this section shall only be conducted by laboratories that have received approval by EPA, other approved certifying organization, or the State of Delaware. To receive approval to conduct analyses for antimony, arsenic, asbestos, barium, beryllium, cadmium, chromium, cyanide, fluoride, mercury, nickel, nitrate, nitrite, selenium and thallium the laboratory must:

9.1.17.1.4.1 Analyze Performance Evaluation samples annually in accordance with subsection 1.14; and

9.1.17.1.4.2 Achieve quantitative results on the analyses that are in accordance with 40 CFR 141.23(k)(3)(ii) as amended. Copies may be obtained from the Office of Drinking Water.

9.2 Organic Chemical Requirements:

9.2.1 PMCLs: The following are the organic PMCLs (mg/L-milligrams per liter). Compliance is determined pursuant to subsections 9.2.2, 9.2.3, and 9.2.4.

9.2.1.1 The following maximum contaminant levels for synthetic organic contaminants apply to community water systems and non-transient, non-community water systems:

Pesticides and PCBs

9.2.1.2 Disinfection Byproducts (DBPs)

9.2.1.2.1 Maximum Contaminant Level Goals for disinfection byproducts.

9.2.1.3 Volatile Synthetic Organic Chemicals (VOCs)

9.2.2 Sampling, Analytical Requirements and Compliance Determination for Contaminants Listed in subsections 9.2.1.1, 9.2.1.2 and 9.2.1.3:

9.2.2.1 Monitoring of the contaminants listed in subsection 9.2.1.1 for the purposes of determining compliance with the MCLs shall be conducted as follows:

9.2.2.1.1 Groundwater systems shall take a minimum of one sample at every entry point to the distribution system which is representative of each well after treatment (hereafter called a sampling point). Each sample must be taken at the same sampling point unless conditions make another sampling point more representative of each source or treatment plant.

9.2.2.1.2 Surface water systems shall take a minimum of one sample at points in the distribution system that are representative of each source or at each entry point to the distribution system after treatment (hereafter called a sampling point). Each sample must be taken at the same sampling point unless conditions make another sampling point more representative of each source or treatment plant. (NOTE: For purposes of this paragraph, surface water systems include systems with a combination of surface and ground sources).

9.2.2.1.3 If the system draws water from more than one source and the sources are combined before distribution, the system must sample at an entry point to the distribution system during periods of normal operating condition (i.e., when water representative of all sources is being used).

9.2.2.1.4 Monitoring frequency:

9.2.2.1.4.1 Each community and non-transient non-community water system shall take four consecutive quarterly samples for each contaminant listed in subsection 9.2.1.1 during each compliance period beginning with the compliance period starting January 1, 1993.

9.2.2.1.4.2 Systems serving more than 3,300 persons which do not detect a contaminant in the initial compliance period may reduce the sampling frequency to a minimum of two quarterly samples in one year during each repeat compliance period.

9.2.2.1.4.3 Systems serving less than or equal to 3,300 persons which do not detect a contaminant in the initial compliance period may reduce the sampling frequency to a minimum of one sample during each repeat compliance period.

9.2.2.1.5 Each community and non-transient water system which does not detect a contaminant listed in subsection 9.2.1.1 may apply to the Division for a waiver from the requirement of subsection 9.2.2.1.4.1 upon completion of the initial monitoring. A system must reapply for a waiver at the end of each compliance period.

9.2.2.1.6 The Division may grant a waiver after evaluating the following factors: Knowledge of previous use (including transport, storage, or disposal) of the contaminant within the watershed or zone of influence of the system. If a determination by the Division reveals no previous use of the contaminant within the watershed or zone of influence, a waiver may be granted. If previous use of the contaminant is unknown, or it has been used previously, then the following factors shall be used to determine whether a waiver is granted:

9.2.2.1.6.1 Previous analytical results.

9.2.2.1.6.2 The proximity of the system to a potential point or non-point source of contamination. Point sources include spills and leaks of chemicals at or near water treatment facilities or at manufacturing, distribution, or storage facilities, or from hazardous and municipal waste landfills and other waste handling or treatment facilities. Non-point sources include the use of pesticides to control insect and weed pests on agricultural areas, forest lands, home and gardens, and other land application uses.

9.2.2.1.6.3 The environmental persistence and transport of the pesticide or PCBs.

9.2.2.1.6.4 How well the water source is protected against contamination due to such factors as depth of the well, the type of soil and the integrity of the well casing.

9.2.2.1.6.5 Elevated nitrate levels at the water supply source.

9.2.2.1.6.6 Use of PCBs in equipment used in the production, storage or distribution of water (i.e., PCBs used in pumps, transformers, etc.).

9.2.2.1.7 If an organic contaminant listed in subsection 9.2.1.1 is detected in any sample then:

9.2.2.1.7.1 Each system must monitor quarterly at each sampling point which resulted in a detection.

9.2.2.1.7.2 The Division may decrease the quarterly monitoring requirement specified in subsection 9.2.2.7.1 provided it has determined that the system is reliably and consistently below the maximum contaminant level. In no case shall the Division make this determination unless a groundwater system takes a minimum of two quarterly samples and a surface water system take a minimum of four quarterly samples.

9.2.2.1.7.3 After the Division determines the system is reliably and consistently below the maximum contaminant level the Division may allow the system to monitor annually. Systems which monitor annually must monitor during the quarter that previously yielded the highest analytical result.

9.2.2.1.7.4 Systems which have 3 consecutive annual samples with no detection of a contaminant may apply to the Division for a waiver as specified in subsection 9.2.2.1.6; and

9.2.2.1.7.5 If monitoring results in detection of one or more of certain related contaminants (heptachlor or heptachlor epoxide), then subsequent monitoring shall analyze for all related contaminants.

9.2.2.1.8 Systems which violate the MCL listed in subsection 9.2.1.1 must monitor quarterly. After a minimum of four quarterly samples show the system is in compliance and the Division determines the system to be reliably and consistently below the MCL as specified in subsection 9.2.2.1.11, the system shall monitor at the frequency specified in subsection 9.2.2.1.7.3.

9.2.2.1.9 The Division may require a confirmation sample for positive or negative results. If a confirmation sample is required by the Division, the result must be averaged with the first sampling result and the average used for the compliance determination as specified in subsection 9.2.2.1.11. The Division has the discretion to delete results of obvious sampling errors from this calculation.

9.2.2.1.10 The Division may reduce the total number of samples a system must analyze by allowing the use of compositing. Composite samples from a maximum of five sampling points are allowed. Detection Limit must be less than one-fifth of the MCL. Compositing of samples must be done in the laboratory and analyzed within 14 days of sample collections.

9.2.2.1.10.1 If the concentration in the composite sample detects one or more contaminants listed in subsection 9.2.1.1 then a follow-up sample must be taken and analyzed within 14 days from each sampling point included in the composite.

9.2.2.1.10.2 If duplicates of the original sample taken from each sampling point used in the composite are available, the system may use these duplicates instead of resampling. The duplicate must be analyzed and the results reported to the Division within 14 days of collection.

9.2.2.1.10.3 If the population served by the system is >3,300 persons, then compositing may only be permitted by the Division at sampling points within a single system. In systems serving ≤3,300 persons, the Division may permit compositing among different systems provided the 5-sample limit is maintained.

9.2.2.1.11 Compliance with subsection 9.2.1.1 shall be determined based on the analytical results obtained at each sampling point. If one sampling point is in violation of the MCL, the system is in violation of the MCL.

9.2.2.1.11.1 For systems which are conducting monitoring at a frequency greater than annually, compliance is determined by a running annual average of all samples taken at each sampling point. If the annual average of any sampling point is greater than the MCL, then the system is out of compliance. If the initial sample or a subsequent sample would cause the annual average to be exceeded, then the system is out of compliance immediately. Any samples below the detection limit shall be calculated as zero for purposes of determining the annual average.

9.2.2.1.11.2 If monitoring is conducted annually, or less frequently, the system is out of compliance if the level of a contaminant at any sampling point is greater than the MCL. If a confirmation sample is required by the Division, the determination of compliance will be based on the average of the two samples.

9.2.2.1.11.3 If any sample result will cause the running annual average to exceed the MCL at any sampling point, the system is out of compliance with the MCL immediately.

9.2.2.1.11.4 If a system fails to collect the required number of samples, compliance will be based on the total number of samples collected.

9.2.2.1.11.5 If a sample result is less than the detection limit, zero will be used to calculate the annual average.

9.2.2.1.11.6 If a public water system has a distribution system separable from other parts of the distribution system with no interconnections, the Division may allow the system to give public notice to only that portion of the system which is out of compliance.

9.2.2.1.12 Analysis for the contaminants listed in subsection 9.2.1.1 shall be conducted in accordance with 40 CFR 141.24(e). Copies may be obtained from the Office of Drinking Water.

9.2.2.1.13 Analysis for PCBs shall be conducted as follows:

9.2.2.1.13.1 Each system which monitors for PCBs shall analyze each sample in accordance with 40 CFR 141.24(h)(13)(i) (see subsection 9.2.2.13.2). Copies may be obtained from the Office of Drinking Water.

9.2.2.1.13.2 If PCBs (as one of seven Aroclors) are detected (as designated in this 40 CFR 141.24(h)(13)(ii)) in any sample analyzed using subsection 9.2.2.13.1, the system shall reanalyze the sample in accordance with 40 CFR 141.24(h)(13)(ii) to quantitate PCBs (as decachlorobiphenyl). Copies may be obtained from the Office of Drinking Water.

9.2.2.1.13.3 Compliance with the PCB MCL shall be determined based upon the quantitative results of analyses conducted in accordance with 40 CFR 141.24(h)(13)(iii). Copies may be obtained from the Office of Drinking Water.

9.2.2.1.14 If monitoring data collected after January 1, 1990, are generally consistent with the requirements of subsection 9.2.2, then the Division may allow systems to use that data to satisfy the monitoring requirement for the initial compliance period beginning January 1, 1993.

9.2.2.1.15 The Division may increase the required monitoring frequency, where necessary, to detect variations within the system (e.g., fluctuations in concentration due to seasonal use, changes in water source).

9.2.2.1.16 The Division has the authority to determine compliance or initiate enforcement action based upon analytical results and other information compiled by their sanctioned representatives and agencies.

9.2.2.1.17 Each public water system shall monitor at the time designated by the Division within each compliance period.

9.2.2.1.18 Detection as used in this paragraph shall be defined as found in 40 CFR 141.24(h)(18). Copies may be obtained from the Office of Drinking Water.

9.2.2.1.19 Analysis under this section shall only be conducted by laboratories that have received certification by EPA or the Division and have met the following conditions:

9.2.2.1.19.1 To receive certification to conduct analyses for the contaminants in subsections 9.2.1.1 and 9.2.1.3 the laboratory must:

9.2.2.1.19.1.1 Analyze Performance Evaluation samples annually in accordance with subsection 1.14; and

9.2.2.1.19.1.2 The laboratory shall achieve quantitative results on the analyses that are within the acceptance limits: specified in 40 CFR 141.24(h)(19)(i)(B). Copies may be obtained from the Office of Drinking Water.

9.2.2.1.20 All new systems or systems that use a new source of water that begins operation after January 22, 2004 must demonstrate compliance with the MCL within a period of time specified by the Division. The system must also comply with the initial sampling frequencies specified by the Division to ensure a system can demonstrate compliance with the MCL. Routine and increased monitoring frequencies shall be conducted with the requirements in this section.

9.2.2.2 Sampling, Analytical Requirements and Compliance Determination for VOCs: Monitoring of the contaminants listed in subsection 9.2.1.3 for the purpose of determining compliance with the MCLs shall be conducted as follows:

9.2.2.2.1 Groundwater systems shall take a minimum of one sample at every entry point to the distribution system which is representative of each well after treatment (hereafter called a sampling point). If conditions warrant, the Division may designate additional sampling points within the distribution system or at the consumer's tap which more accurately determine consumer exposure. Each sample must be taken at the same sampling point unless conditions make another sampling point more representative of each source or treatment plant.

9.2.2.2.2 Surface water systems shall take a minimum of one sample at points in the distribution system that are representative of each source or at each entry point to the distribution system after treatment (hereafter called a sampling point). If conditions warrant, the Division may designate additional sampling points within the distribution system or at the consumer's tap which more accurately determines consumer exposure. Each sample must be taken at the same sampling point unless conditions make another sampling point more representative of each source, treatment plant, or within the distribution system. NOTE: For purposes of this paragraph, surface water systems include systems with a combination of surface and ground surfaces.

9.2.2.2.3 If the system draws water from more than one source and the sources are combined before distribution, the system must sample at an entry point to the distribution system during periods of normal operating conditions (i.e., when water representative of all sources is being used).

9.2.2.2.4 Each community and non-transient non-community water system shall take four consecutive quarterly samples for each contaminant listed in subsection 9.2.1.3, during each compliance period beginning in the initial compliance period.

9.2.2.2.5 Groundwater and surface water systems which do not detect one of the contaminants listed in subsection 9.2.1.3 after conducting the initial round of monitoring required in subsection 9.2.2.2.4 of this section may take one sample annually.

9.2.2.2.6 For groundwater and surface water systems, if the initial monitoring for contaminants listed in subsection 9.2.1.3 as allowed in subsection 9.2.2.2.18 has been completed by December 31, 1992 and the system did not detect any contaminant listed in subsection 9.2.1.3 then the system shall take one sample annually. After a minimum of three years of annual sampling, the Division may allow groundwater systems which have no previous detection of any contaminant listed in subsection 9.2.1.3 to take one sample during each compliance period.

9.2.2.2.7 Each community and non-transient non-community groundwater system which does not detect a contaminant listed in subsection 9.2.1.3 may apply to the Division for a waiver from the requirement of subsections 9.2.2.2.5 and 9.2.2.2.6 after completing the initial monitoring. (For the purposes of this section, detection is defined as >0.0005 mg/L). A waiver shall be effective for no more than six years (two compliance periods).

9.2.2.2.7.1 The Division may also issue waivers to small systems (those serving ≤3,300 persons) for the initial round of monitoring for 1,2,4-trichlorobenzene.

9.2.2.2.8 The Division may grant a waiver after evaluating the following factor(s):

9.2.2.2.8.1 Knowledge of previous use (including transport, storage, or disposal) of the contaminant within the watershed or zone of influence of the system. If a determination by the Division reveals no previous use of the contaminant within the watershed or zone of influence, a waiver may be granted.

9.2.2.2.8.2 If previous use of the contaminant is unknown or it has been used previously, then the following factors shall be used to determine whether a waiver is granted.

9.2.2.2.8.2.1 Previous analytical results.

9.2.2.2.8.2.2 The proximity of the system to potential point or non-point source of contamination. Point sources include spills and leaks of chemicals at or near a water treatment facility or at manufacturing, distribution, or storage facilities, or from hazardous and municipal waste landfills and other waste handling or treatment facilities.

9.2.2.2.8.2.3 The environmental persistence and transport of the contaminants.

9.2.2.2.8.2.4 The number of persons served by the public water system and the proximity of a smaller system to a larger system.

9.2.2.2.8.2.5 How well the water source is protected against contamination such as whether it is a surface or groundwater system. Groundwater systems must consider factors such as depth of the well, the type of soil, and well head protection. Surface water systems must consider watershed protection.

9.2.2.2.9 As a condition of the waiver a system must take one sample at each sampling point during the time the waiver is effective (i.e., one sample during two compliance periods or six years) and update its vulnerability assessment considering the factors listed in subsection 9.2.2.2.8. Based on this vulnerability assessment the Division must confirm that the system is non-vulnerable. If the Division does not make this reconfirmation within three years of the initial determination, then the waiver is invalidated and the system is required to sample annually as specified in subsection 9.2.2.2.5.

9.2.2.2.10 Each community and non-transient non-community surface water system which does not detect a contaminant listed is subsection 9.2.1.3 may apply to the Division for a waiver from the requirements of subsection 9.2.2.2.6 after completing the initial monitoring. Composite samples from a maximum of five sampling points are allowed, provided that the detection limit of the method used for analysis is less than one-fifth of the MCL. Systems meeting this criterion must be determined by the Division to be non-vulnerable based on a vulnerability assessment during each compliance period. Each system receiving a waiver shall sample at the frequency specified by the Division (if any).

9.2.2.2.11 If a contaminant listed in subsection 9.2.1.3, excluding vinyl chloride, is detected at a level exceeding 0.0005 mg/L in any sample then:

9.2.2.2.11.1 The system must monitor quarterly at each sampling point which resulted in a detection;

9.2.2.2.11.2 The Division may decrease the quarterly monitoring requirement specified in subsection 9.2.2.2.11.1 provided it has determined that the system is reliably and consistently below the maximum contaminant level. In no case shall the Division make this determination unless a groundwater system takes a minimum of two quarterly samples and a surface water system takes a minimum of four quarterly samples;

9.2.2.2.11.3 If the Division determines that the system is reliably and consistently below the MCL, the Division may allow the system to monitor annually. Systems which monitor annually must monitor during the quarter or quarters which previously yielded the highest analytical result;

9.2.2.2.11.4 Systems which have three consecutive annual samples with no detection of a contaminant may apply to the Division for a waiver as specified in subsection 9.2.2.2.7; and

9.2.2.2.11.5 Groundwater systems which have detected one or more of the following two-carbon organic compounds: trichloroethylene, tetrachloroethylene, 1,2-dichloroethane, trans-1,2-dichloroethylene, 1,1,1-trichloroethane, cis-1,2-dichloroethylene or 1,1-dichloroethylene shall monitor quarterly for vinyl chloride. A vinyl chloride sample shall be taken at each sampling point at which one or more of the two-carbon organic compounds was detected. If the results of the first analysis do not detect vinyl chloride, the Division may reduce the quarterly monitoring frequency of vinyl chloride monitoring to one sample during each compliance period. Surface water systems are required to monitor for vinyl chloride as specified by the Division.

9.2.2.2.12 Systems which violate the requirements of subsection 9.2.1.3 as determined by subsection 9.2.2.2.15 must monitor quarterly. After a minimum of four consecutive quarterly samples shows the system is in compliance as specified in subsection 9.2.2.2.15, and the Division determines that the system is reliably and consistently below the maximum contaminant level, the system may monitor at the frequency and time specified in subsection 9.2.2.2.11.3.

9.2.2.2.13 The Division may require a confirmation sample for positive or negative results. If a confirmation sample is required by the Division, the result must be averaged with the first sampling result and the average is used for the compliance determination as specified by subsection 9.2.2.2.15. The Division has the discretion to delete results of obvious sampling errors from this calculation.

9.2.2.2.14 The Division may reduce the total number of samples a system must analyze by allowing the use of compositing. Composite samples from a maximum of five sampling points are allowed, providing that the detection limit of the method used for analysis is less than one-fifth of the MCL. Compositing of samples must be done in the laboratory and analyzed within 14 days of sample collection.

9.2.2.2.14.1 If the concentration in the composite sample is >0.0005 mg/L for any contaminant listed in subsection 9.2.1.3, then a follow-up sample must be taken and analyzed within 14 days from each sampling point included in the composite.

9.2.2.2.14.2 If duplicates of the original sample taken from each sampling point used in the composite are available, the system may use these instead of resampling. The duplicate must be analyzed and the results reported to the Division within 14 days of collection.

9.2.2.2.14.3 If the population served by the system is >3,300 persons, then compositing may only be permitted by the Division at sampling points within a single system. In systems serving ≤3,300 persons, the Division may permit compositing among different systems provided the 5-sample limit is maintained.

9.2.2.2.14.4 Compositing samples prior to GC analysis:

9.2.2.2.14.4.1 Add 5 ml or equal larger amounts of each sample (up to 5 samples are allowed) to a 25 ml glass syringe. Special precautions must be made to maintain zero headspace in the syringe.

9.2.2.2.14.4.2 The samples must be cooled at 4o C during this step to minimize volatilization losses.

9.2.2.2.14.4.3 Mix well and draw out a 5-ml aliquot for analysis.

9.2.2.2.14.4.4 Follow sample introduction, purging and desorption steps described in the method.

9.2.2.2.14.4.5 If less than five samples are used for compositing, a proportionately small syringe may be used.

9.2.2.2.14.5 Compositing samples prior to GC/MS analysis:

9.2.2.2.14.5.1 Inject 5-ml or equal larger amounts of each aqueous sample (up to 5 samples are allowed) into a 25-ml purging device using the sample introduction technique described in the method.

9.2.2.2.14.5.2 The total volume of the sample in the purging device must be 25 ml.

9.2.2.2.14.5.3 Purge and desorb as described in the method.

9.2.2.2.15 Compliance with subsection 9.2.1.3 shall be determined based on the analytical results obtained at each sampling point:

9.2.2.2.15.1 For systems which are conducting monitoring at a frequency greater than annual, compliance is determined by a running annual average of all samples taken at each sampling point. If the annual average of any sampling point is greater than the MCL, then the system is out of compliance. If the initial sample or a subsequent sample would cause the annual average to be exceeded, then the system is out of compliance immediately. Any samples below the detection limit shall be calculated as zero for purposes of determining the annual average.

9.2.2.2.15.2 If monitoring is conducted annually, or less frequently, the system is out of compliance if the level of a contaminant at any sampling point is greater than the MCL. If a confirmation sample is required by the Division, the determination of compliance will be based on the average of the two samples.

9.2.2.2.15.3 If a public water system has a distribution system separable from other parts of the distribution system with no interconnections, the Division may allow the system to give public notice to only that area served by that portion of the system which is out of compliance.

9.2.2.2.16 Analysis for the contaminants listed in subsection 9.2.1.3 shall be conducted in accordance with 40 CFR 141.24(e). Copies may be obtained from the Office of Drinking Water.

9.2.2.2.17 Analysis under this section shall only be conducted by laboratories that have received approval by EPA or the Division according to the following conditions:

9.2.2.2.17.1 To receive conditional approval to conduct analyses for the contaminants in subsection 9.2.1.3, excluding vinyl chloride, the laboratory must:

9.2.2.2.17.1.1 Analyze Performance Evaluation samples annually.

9.2.2.2.17.1.2 Achieve the quantitative acceptance limits for at least 80 percent of the regulated organic chemicals listed in subsection 9.2.1.3.

9.2.2.2.17.1.3 Achieve quantitative results on the analyses performed under subsection 9.2.2.3.16 that are within ±20 percent of the actual amount of the substances in the Performance Evaluation sample when the actual amount is greater than or equal to 0.010 mg/L.

9.2.2.2.17.1.4 Achieve quantitative results on the analyses performed under subsection 9.2.2.2.16 that are within ±40 percent of the actual amount of the substance in the Performance Evaluation sample when the actual amount is less than 0.010 mg/L.

9.2.2.2.17.1.5 Achieve a method detection limit of 0.0005 mg/L according to the procedures listed in Appendix B of 40 CFR Part 136. Copies may be obtained from the Office of Drinking Water.

9.2.2.2.17.1.5.1 Reserved

9.2.2.2.17.2 To receive certification for vinyl chloride, the laboratory must:

9.2.2.2.17.2.1 Analyze Performance Evaluation samples annually.

9.2.2.2.17.2.2 Achieve quantitative results on the analyses performed under subsection 9.2.2.2.17.2.1 that are within ±40 percent of the actual amount of vinyl chloride in the Performance Evaluation sample.

9.2.2.2.17.2.3 Achieve a method detection limit of 0.0005 mg/l, according to the procedures listed in Appendix B of 40 CFR Part 136. Copies may be obtained from the Office of Drinking Water.

9.2.2.2.17.2.4 Obtain certification for the contaminants listed in subsection 9.2.1.3.

9.2.2.2.18 The Division may allow the use of monitoring data collected after January 1, 1988 for purposes of initial monitoring compliance. If the data are generally consistent with the other requirements in this section, the Division may use those data (i.e., a single sample rather than four quarterly samples) to satisfy the initial monitoring requirement of subsection 9.2.2.2.4.

9.2.2.2.18.1 Systems which use grandfathered samples and did not detect any contaminant listed in subsection 9.2.1.3, excluding vinyl chloride, shall begin monitoring annually in accordance with subsection 9.2.2.2.6 beginning with the initial compliance period.

9.2.2.2.19 The Division may increase required monitoring where necessary to detect variations within the system.

9.2.2.2.20 Each approved laboratory must determine the method detection limit (MDL), as defined in Appendix B of 40 CFR Part 136, copies may be obtained from the Office of Drinking Water, at which it is capable of detecting VOCs. The acceptable MDL is 0.0005 mg/L. This concentration is the detection concentration for purposes of this section.

9.2.2.2.21 Each public water system shall monitor at the time designated by the Division within each compliance period.

9.3 Best Available Technologies (BAT)

9.3.1 The Division hereby identifies as indicated in the table below either granular activated carbon (GAC), packed tower aeration (PTA), or oxidation (OX) through chlorination or ozonation as the best technology, treatment technique, or other means available for achieving compliance with the maximum contaminant level for organic contaminants identified in subsections 9.2.1.1 and 9.2.1.3.

BAT for Organic Contaminants Listed in subsections 9.2.1.1 and 9.2.1.3

BAT for Organic Contaminants Listed in subsection 9.2.1.2

9.3.1.1 The Administrator, pursuant to section 1412 of the Act, hereby identifies the following as the best technology, treatment techniques, or other means available for achieving compliance with the maximum contaminant levels for TTHM and HAA5 identified in subsection 9.2.1.2 for all systems that disinfect their source water:

Disinfection Byproduct

Best Available Technology

Total trihalomethanes (TTHM) and Haloacetic acids (five) (HAA5)

Enhanced coagulation or enhanced softening, plus GAC10; or nanofiltration with a molecular weight cutoff ≤1000 Daltons; or GAC20.]

9.3.1.2 The Administrator, pursuant to section 1412 of the Act, hereby identifies the following as the best technology, treatment techniques, or other means available for achieving compliance with the maximum contaminant levels for TTHM and HAA5 identified in subsection 9.2.1.2 for consecutive systems and applies only to the disinfected water that consecutive systems buy or otherwise receive:

9.3.2 BAT for Inorganic Contaminants Listed in subsection 9.1.1.1

Key to BATs in Table

1 = Activated Alumina

2 = Coagulation/Filtration (Not BAT for systems <500 service connections)

3 = Direct and Diatomite Filtration

4 = Granular Activated Carbon

5 = Ion Exchange

6 = Lime Softening (Not BAT for systems <500 service connections)

7 = Reverse Osmosis

8 = Corrosion Control

9 = Electrodialysis

10 = Chlorine

11 = Ultraviolet

12 = Oxidation/Filtration

9.3.3 Treatment techniques for acrylamide and epichlorohydrin.

9.3.3.1 Each public water system must certify annually in writing to the Division (using a third party or manufacturer's certification) that when acrylamide and epichlorohydrin are used in drinking water systems, the combination (or product) of dose and monomer level does not exceed the levels specified as follows:

Acrylamide = 0.05% dosed at 1 PPM (or equivalent).

Epichlorohydrin = 0.01% dosed at 20 PPM (or equivalent).

9.3.4 The Administrator, U.S. Environmental Protection Agency, pursuant to section 1412 of the Safe Drinking Water Act, hereby identifies in the following table the affordable technology, treatment technique, or other means available to systems serving 10,000 persons or fewer for achieving compliance with the MCL for arsenic:

Small System Compliance Technologies (SSCTs)1 for Arsenic2

**History**
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *25 DE Reg. 713 (01/01/22)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *5 DE Reg. 2121 (05/01/02)*
- *9 DE Reg. 999 (12/01/05)*
- *15 DE Reg. 73 (07/01/12)*
- *17 DE Reg. 439 (10/01/13)*
- *19 DE Reg. 517 (12/01/15)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *25 DE Reg. 713 (01/01/22)*

##### **16 Del. Admin. Code § 4462-10.0** Lead (Pb) and Copper (Cu) {#sec-4462-10.0 omnilex-key=us-de-regs-official--title-16--4462-10.0}

10.1 Unless otherwise indicated, each of the provisions of this section applies to CWSs and NTNCWSs. The requirements in Section 10.0 shall take effect November 9, 1992.

10.1.1 General Requirements: Applicability and effective dates.

10.1.1.1 The requirements of Section 10.0 constitute national primary drinking water regulations for lead and copper. Unless otherwise indicated, each of the provisions of this section applies to community water systems and non-transient, non-community water systems (hereinafter referred to as “water systems” or “systems”).

10.1.1.2 Reserved

10.1.2 Scope. These regulations establish a treatment technique that includes requirements for corrosion control treatment, source water treatment, lead service line replacement, and public education. These requirements are triggered, in some cases, by lead and copper action levels measured in samples collected at consumer’s taps.

10.1.3 Action Level:

10.1.3.1 The lead action level is exceeded if the concentration of lead in more than 10 percent of tap water samples collected during any monitoring period conducted in accordance with subsection 10.7 is greater than 0.015 mg/L (i.e., if the “90th percentile” lead level is greater than 0.015 mg/L).

10.1.3.2 The copper action level is exceeded if the concentration of copper in more than 10 percent of tap water samples collected during any monitoring period conducted in accordance with subsection 10.7 is greater than 1.3 mg/L (i.e., if the “90th percentile” copper level is greater than 1.3 mg/L).

10.1.3.3 The 90th percentile lead and copper levels shall be computed as follows:

10.1.3.3.1 The results of all lead or copper samples taken during a monitoring period shall be placed in ascending order from the sample with the lowest concentration to the sample with the highest concentration. Each sampling result shall be assigned a number ascending by single integers beginning with the number 1 for the sample with the lowest contaminant level. The number assigned to the sample with the highest contaminant level shall be equal to the total number of samples taken.

10.1.3.3.2 The number of samples taken during the monitoring period shall be multiplied by 0.9.

10.1.3.3.3 The contaminant concentration in the numbered sample yielded by the calculation in subsection 10.1.3.3.2 is the 90th percentile contaminant level.

10.1.3.3.4 For water systems serving fewer than 100 people that collect five samples per monitoring period, the 90th percentile is computed by taking the average of the highest and second highest concentrations.

10.1.3.3.5 For a public water system that has been allowed by the Division to collect fewer than five samples in accordance with subsection 10.7.3 the sample result with the highest concentration is considered the 90th percentile value.

10.1.4 Corrosion Control Treatment Requirements:

10.1.4.1 All water systems shall install and operate optimal corrosion control treatment as defined in Section 2.0.

10.1.4.2 Any water system that complies with the applicable corrosion control treatment requirements specified by the Division under subsections 10.2 and 10.3 shall be deemed in compliance with each treatment requirement contained in subsection 10.1.4.1.

10.1.5 Source Water Treatment Requirements: Any system exceeding the lead or copper action level shall implement all applicable source water treatment requirements specified by the Division under subsection 10.4.

10.1.6 Lead Service Line Replacement: Any system exceeding the lead action level after implementation of applicable corrosion control and source water treatment requirements shall complete the lead service line replacement requirements contained in subsection 10.5.

10.1.7 Public Education Requirements: Pursuant to subsection 10.6, all water systems must provide a consumer notice of lead tap water monitoring results to persons served at the sites (taps) that are tested. Any system exceeding the lead action level shall implement the public education requirements contained in subsection 10.6.

10.1.8 Monitoring and Analytical Requirements: Tap water monitoring for lead and copper, monitoring for water quality parameters, source water monitoring for lead and copper, and analyses of the monitoring results under this section shall be completed in compliance with subsections 10.7, 10.8, 10.9 and 10.12.

10.1.9 Reporting Requirements: Systems shall report to the Division any information required by the treatment provisions of this section and subsection 10.10.

10.1.10 Recordkeeping Requirements: Systems shall maintain records in accordance with subsection 10.11.

10.1.11 Violation of National Primary Drinking Water Regulations:

10.1.11.1 Failure to comply with the applicable requirements of Section 10.0 including requirements established by the Division pursuant to these provisions, shall constitute a violation of the national primary drinking water regulations for lead and/or copper.

10.2 Applicability of Corrosion Control Treatment Steps for Small, Medium-Size and Large Water Systems:

10.2.1 Systems shall complete the applicable corrosion control treatment requirements described in subsection 10.3 by the deadlines established in this section.

10.2.1.1 A large system (serving >50,000 persons) shall complete the corrosion control treatment steps specified in subsection 10.2.4, unless it is deemed to have optimized corrosion control under subsection 10.2.2.2 or 10.2.2.3.

10.2.1.2 A small system (serving <3,300 persons) and a medium-size system (serving >3,300 and <50,000 persons) shall complete the corrosion control treatment steps specified in paragraph 10.2.5, unless it is deemed to have optimized corrosion control under subsections 10.2.2.1, 10.2.2.2 or 10.2.2.3.

10.2.2 A system is deemed to have optimized corrosion control and is not required to complete the applicable corrosion control treatment steps identified in this section if the system satisfies one of the following criteria specified in subsections 10.2.2.1 through 10.2.2.3. Any such system deemed to have optimized corrosion control under this paragraph, and which has treatment in place, shall continue to operate and maintain optimal corrosion control treatment and meet any requirements that the Division determines appropriate to ensure that optimal corrosion control treatment is maintained.

10.2.2.1 A small or medium-size water system is deemed to have optimized corrosion control if the system meets the lead and copper action levels during each of two consecutive six-month monitoring periods conducted in accordance with subsection 10.7.

10.2.2.2 Any water system may be deemed by the Division to have optimized corrosion control treatment if the system demonstrates to the satisfaction of the Division that it has conducted activities equivalent to the corrosion control steps applicable to such system under this section. If the Division makes this determination, it shall provide the systems with written notice explaining the basis for its decision and shall specify the water quality control parameters representing optimal corrosion control in accordance with subsection 10.3.6. Water systems deemed to have optimized corrosion control under this paragraph shall operate in compliance with the Division-designated optimal water quality control parameters in accordance with subsection 10.3.7 and continue to conduct lead and copper tap and water quality parameter sampling in accordance with subsection 10.7.4.3 and subsection 10.8.4 respectively. A system shall provide the Division with the following information in order to support a determination under this paragraph.

10.2.2.2.1 The results of all test samples collected for each of the water quality parameters in subsection 10.3.3.3.

10.2.2.2.2 A report explaining the test methods used by the water system to evaluate the corrosion control treatments listed in subsection 10.3.3.1, the results of all tests conducted, and the basis for the system’s selection of optimal corrosion control treatment.

10.2.2.2.3 A report explaining how corrosion control has been installed and how it is being maintained to insure minimal lead and copper concentrations at consumer’s taps; and

10.2.2.2.4 The results of tap water samples collected in accordance with subsection 10.7 at least once every six months for one year after corrosion control has been installed.

10.2.2.3 Any water system is deemed to have optimized corrosion control if it submits results of tap water monitoring conducted in accordance with subsection 10.7 and source water monitoring conducted in accordance with subsection 10.9 that demonstrates for two consecutive six-month monitoring periods that the difference between the 90th percentile tap water lead level computed under subsection 10.1.3.3, and the highest source water lead concentration, is less than the Practical Quantitation Level (PQL) for lead specified in subsection 10.12.

10.2.2.3.1 Those systems whose highest source water lead level is below the Method Detection Limit may also be deemed to have optimized corrosion control under this paragraph if the 90th percentile tap water lead level is less than or equal to the Practical Quantitation Level for lead for two consecutive six-month monitoring periods.

10.2.2.3.2 Any water system deemed to have optimized corrosion control in accordance with this paragraph shall continue monitoring for lead and copper at the tap no less frequently than once every three calendar years using the reduced number of sites specified in subsection 10.7.3 and collect the samples at times and locations specified in subsection 10.7.4.4. Any such system that has not conducted a round of monitoring pursuant to subsection 10.7.4 since September 30, 1997, shall complete a round of monitoring pursuant to this paragraph no later than September 30, 2000.

10.2.2.3.3 Any water system deemed to have optimized corrosion control pursuant to this paragraph shall notify the Division in writing pursuant to subsection 10.10.1.3 of any upcoming long-term change in treatment or addition of a new source as described in that section. The Division must review and approve the addition of a new source or long-term change in water treatment before it is implemented by the water system. The Division may require any such system to conduct additional monitoring or to take other action the Division deems appropriate to ensure that such systems maintain minimal levels of corrosion in the distribution system.

10.2.2.3.4 As of July 12, 2001 a system is not deemed to have optimized corrosion control under this paragraph, and shall implement corrosion control treatment pursuant to subsection 10.2.2.3.5 unless it meets the copper action level.

10.2.2.3.5 Any system triggered into corrosion control because it is no longer deemed to have optimized corrosion control under this paragraph shall implement corrosion control treatment in accordance with the deadlines in subsection 10.2.5. Any such large system shall adhere to the schedule specified in that section for medium-sized systems, with the time periods for completing each step being triggered by the date the system is no longer deemed to have optimized corrosion control under this section.

10.2.3 Any small or medium-size water system that is required to complete the corrosion control steps due to its exceedance of the lead or copper action level may cease completing the treatment steps whenever the system meets both action levels during each of two consecutive monitoring periods conducted pursuant to subsection 10.7 and submits the results to the Division. If any such water system thereafter exceeds the lead or copper action level during any monitoring period, the system (or the Division, as the case may be) shall recommence completion of the applicable treatment steps, beginning with the first treatment step which was not previously completed in its entirety. The Division may require a system to repeat treatment steps previously completed by the system where the Division determines that this is necessary to properly implement the treatment requirements of this section. The Division shall notify the system in writing of such a determination and explain the basis for its decision. The requirement for any small or medium-size system to implement corrosion control treatment steps in accordance with subsection 10.2.5 (including systems deemed to have optimized corrosion control under subsection 10.2.2.1) is triggered whenever any small or medium-size system exceeds the lead or copper action level.

10.2.4 Treatment Steps and Deadlines for Large Systems:

10.2.4.1 Except as provided in subsections 10.2.2.2 and 10.2.2.3, large systems shall complete the following corrosion control treatment steps (described in the referenced portions of subsections 10.3, 10.7 and 10.8 by the indicated dates.

Step 1: The system shall conduct two six month initial monitoring periods by January 1, 1993.

Step 2: The system shall complete corrosion control studies, subsection 10.3.3, in 18 months, by July 1, 1994.

Step 3: The Division shall designate optimal corrosion control treatment, subsection 10.3.4, in 6 months, by January 1, 1995.

Step 4: The system shall install optimal corrosion control treatment, subsection 10.3.5, in 24 months, by January 1, 1997.

Step 5: The system shall complete follow-up sampling, subsection 10.7.4.2 and subsection 10.8.3, in 12 months, by January 1, 1998

Step 6: The Division shall review installation of treatment and designate optimal water quality control parameters, subsection 10.3.6, in 6 months, by July 1, 1998.

Step 7: The system shall operate in compliance with the Division-specified optimal water quality control parameters, subsection 10.3.7, and continue to conduct tap sampling, subsection 10.7.4 and subsection 10.8.4.

10.2.5 Treatment Steps and Deadlines for Small-and Medium-Size Systems:

10.2.5.1 Except as provided in subsection 10.2.2, small and medium-size systems shall complete the following corrosion control treatment steps (described in the referenced portions of subsections 10.3, 10.7 and 10.8 by the indicated time periods.

Step 1: The system shall conduct initial tap sampling, subsection 10.7.4.1 and subsection 10.8.2, until the system either exceeds the lead or copper action level or becomes eligible for reduced monitoring under subsection 10.7.4.4. A system exceeding the lead or copper action level shall recommend optimal corrosion control treatment, subsection 10.3.1, within six months after the end of the monitoring period during which it exceeds one of the action levels.

Step 2: Within 12 months after the end of the monitoring period during which a system exceeds the lead or copper action level, the Division may require the system to perform corrosion control studies (subsection 10.3.2). If the Division does not require the system to perform such studies, the Division shall specify optimal corrosion control treatment, (subsection 10.3.4) within the following time frames.

10.2.5.1.1 For medium-size systems, within 18 months after the end of the monitoring period during which such system exceeds the lead or copper action level.

10.2.5.1.2 For small systems, within 24 months after the end of the monitoring period during which such system exceeds the lead or copper action level.

Step 3: If the Division requires a system to perform corrosion control studies under step 2, the system shall complete the studies, subsection 10.3.3, within 18 months after the Division requires that such studies be conducted.

Step 4: If the system has performed corrosion control studies under step 2, the Division shall designate optimal corrosion control treatment, subsection 10.3.4, within 6 months after completion of step 3.

Step 5: The system shall install optimal corrosion control treatment, subsection 10.3.5, within 24 months after the Division designates optimal corrosion control treatment.

Step 6: The system shall complete follow-up sampling, subsection 10.7.4.2 and subsection 10.8.3, within 36 months after the Division designates optimal corrosion control treatment.

Step 7: The Division shall review the system’s installation of treatment and designate optimal water quality control parameters, subsection 10.3.6, within 6 months after completion of Step 6.

Step 8: The system shall operate in compliance with the Division-designated optimal water quality control parameters, subsection 10.3.7, and continue to conduct tap sampling, subsection 10.7.4.3 and subsection 10.8.4.

10.3 Description of Corrosion Control Treatment Requirements: Each System shall complete the corrosion control treatment requirements described below which are applicable to such systems under subsection 10.2.

10.3.1 System Recommendation Regarding Corrosion Control Treatment: Based upon the results of lead and copper tap monitoring and water quality parameter monitoring, small and medium-size water systems exceeding the lead or copper action level shall recommend installation of one or more of the corrosion control treatments listed in subsection 10.3.3.1 which the system believes constitutes optimal corrosion control for that system. The Division may require the system to conduct additional water quality parameter monitoring in accordance with subsection 10.8.2 to assist the Division in reviewing the system’s recommendation.

10.3.2 Division Decision to Require Studies of Corrosion Control Treatment (Applicable to Small and Medium-Size Systems): The Division may require any small or medium-size system that exceeds the lead or copper action level to perform corrosion control studies under subsection 10.3.3 to identify optimal corrosion control treatment for the system.

10.3.3 Performance of Corrosion Control Studies:

10.3.3.1 Any public water system performing corrosion control studies shall evaluate the effectiveness of each of the following treatments, and, if appropriate, combinations of the following treatments to identify the optimal corrosion control treatment for that system:

10.3.3.1.1 Alkalinity and pH adjustment;

10.3.3.1.2 Calcium hardness adjustment; and

10.3.3.1.3 The addition of a phosphate or silicate based corrosion inhibitor at a concentration sufficient to maintain an effective residual concentration in all test tap samples.

10.3.3.2 The water system shall evaluate each of the corrosion control treatments using either pipe ring/loop tests, metal coupon tests, partial-system tests, or analyses based on documented analogous treatments with other systems of similar size, water chemistry and distribution system configuration.

10.3.3.3 The water system shall measure the following water quality parameters in any tests conducted under this paragraph before and after evaluating the corrosion control treatment listed above:

Lead;

Copper;

pH;

Alkalinity;

Calcium;

Conductivity;

Orthophosphate (when an inhibitor containing a phosphate compound is used);

Silicate (when an inhibitor containing a silicate compound is used);

Water temperature.

10.3.3.4 The water system shall identify all chemical or physical constraints that limit or prohibit the use of a particular corrosion control treatment and document such constraints with at least one of the following:

10.3.3.4.1 Data and documentation showing that a particular corrosion control treatment has adversely affected other water treatment processes when used by another water system with comparable water quality characteristics; and/or

10.3.3.4.2 Data and documentation demonstrating that the water system has previously attempted to evaluate a particular corrosion control treatment and has found that the treatment is ineffective or adversely affects other water quality treatment processes.

10.3.3.5 The water system shall evaluate the effect of the chemicals used for corrosion control treatment on other water quality treatments processes.

10.3.3.6 On the basis of an analysis of the data generated during each evaluation, the water system shall recommend to the Division in writing the treatment option that the corrosion control studies indicate constitutes optimal corrosion control treatment for that system. The water system shall provide a rationale for its recommendation along with all supporting documentation specified in subsections 10.3.3.1 through 10.3.3.5.

10.3.4 Division Designation of Optimal Corrosion Control Treatment:

10.3.4.1 Based upon consideration of available information including, where applicable, studies performed under subsection 10.3.3 and a system’s recommended treatment alternative, the Division shall either approve the corrosion control treatment option recommended by the system, or designate alternative corrosion control treatment(s) from among those listed in subsection 10.3.3.1. When designating optimal treatment the Division shall consider the effects that additional corrosion control treatment will have on water quality parameters and on other quality treatment processes.

10.3.4.2 The Division shall notify the system of its decision on optimal corrosion control treatment in writing and explain the basis for this determination within 6 months of receiving follow up samples. If the Division requests additional information to aid its review, the water system shall provide the information.

10.3.5 Installation of Optimal Corrosion Control: Each system shall properly install and operate throughout its distribution system the optimal corrosion control treatment designated by the Division under subsection 10.3.4.

10.3.6 Division Review of Treatment and Specification of Optimal Water Quality Control Parameters: The Division shall evaluate the results of all lead and copper tap samples and water quality parameter samples submitted by the water system and determine whether the system has properly installed and operated the optimal corrosion control treatment designated by the Division in subsection 10.3.4. Upon reviewing the results of tap water and water quality parameter monitoring by the system, both before and after the system installs optimal corrosion control treatment, the Division shall designate:

10.3.6.1 A minimum value or a range of values for pH measured at each entry point to the distribution system;

10.3.6.2 A minimum pH value measured in all tap samples. Such value shall be equal to or greater than 7.0 unless the Division determines that meeting a pH level of 7.0 is not technologically feasible or is not necessary for the system to optimize corrosion control;

10.3.6.3 If a corrosion inhibitor is used, a minimum concentration or a range of concentrations for the inhibitor, measured at each entry point to the distribution system and in all tap samples, that the Division determines is necessary to form a passivating film on the interior walls of the pipes of the distribution system;

10.3.6.4 If alkalinity is adjusted as part of optimal corrosion control treatment, a minimum concentration or a range of concentrations for alkalinity, measured at each entry point to the distribution system and in all tap samples; and

10.3.6.5 If calcium carbonate stabilization is used as part of corrosion control, a minimum concentration or a range of concentrations for calcium, measured in all tap samples. The values for the applicable water quality control parameters listed above shall be those that the Division determines to reflect optimal corrosion control treatment for the system. The Division may designate values for additional water quality control parameters determined by the Division to reflect optimal corrosion control for the system. The Division shall notify the system in writing of these determinations and explain the basis for its decisions.

10.3.7 Continued Operation and Monitoring: All systems shall continue to operate and maintain optimal corrosion control treatment, including maintaining water quality parameter values at or above minimum values or within ranges designated by the Division under subsection 10.3.6 in accordance with this paragraph for all samples collected under subsection 10.8.4 through 10.8.6. Compliance with requirements of this paragraph shall be determined every six months, as specified under subsection 10.8.4. A water system is out of compliance with the requirements of this paragraph for a six-month period if it has excursions for any Division-specified parameter on more than nine days during the period. An excursion occurs whenever the daily value for one or more of the water quality parameters measured at a sampling location is below the minimum value or outside the range designated by the Division. Daily values are calculated as follows. The Division has the discretion to delete results of obvious sampling errors from this calculation.

10.3.7.1 On days when more than one measurement for the water quality parameter is collected at the sampling location, the daily value shall be the average of all the results collected during the day regardless of whether they are collected through continuous monitoring, grab sampling, or a combination of both. If EPA has approved an alternative formula under 40 CFR section 142.16 in the State’s application for a program revision submitted pursuant to 40 CFR section 142.12, the Division’s formula shall be used to aggregate multiple measurements taken at a sampling point for the water quality parameter.

10.3.7.2 On days when only one measurement for the water quality parameter is collected at the sampling location, the daily value shall be that measurement.

10.3.7.3 On days when no measurement is collected for the water quality parameter at the sampling location, the daily value shall be the daily value calculated on the most recent day on which the water quality parameter was measured at the sampling location.

10.3.8 Modification of Division’s Corrosion Control Treatment Decision: Upon its own initiative, or in response to a request by the water system or other interested party, the Division may modify treatment determination. The requests in writing must explain why the change is appropriate and provide supporting documentation. The treatment may be changed when the Division determines that it is necessary for the water system to continue optimizing corrosion control. The Division’s decision must be in writing and specify new treatment, explain the basis for its decision, and provide an implementation schedule for completing the treatment modifications.

10.3.9 EPA Treatment Decisions in Lieu of the Division’s Decisions: The regional administrator may issue federal determinations in lieu of the Division’s determinations when:

10.3.9.1 The Division fails to issue a determination in a timely manner.

10.3.9.2 The Division abuses its discretion in a substantial number of cases or in cases affecting large populations.

10.3.9.3 The technical basis of the Division’s decision is indefensible in federal enforcement action(s).

10.4 Source Water Treatment Requirements: Systems shall complete the applicable source water monitoring and treatment requirements (described in the referenced portions of subsection 10.4.2, and in subsections 10.7 and 10.9 by the following deadlines:

10.4.1 Deadlines for Completing Source Water Treatment Steps:

Step 1: A system exceeding the lead or copper action level shall complete lead and copper source water monitoring (subsection 10.9.2) and make a treatment recommendation to the Division (subsection 10.4.2.1) no later than 180 days after the end of the monitoring period during which the lead or copper action level was exceeded.

Step 2: The Division shall make a determination regarding source water treatment, subsection 10.4.2.2 within 6 months after submission of monitoring results under step 1.

Step 3: If the Division requires installation of source water treatment, the system shall install the treatment, subsection 10.4.2.3, within 24 months after completion of step 2.

Step 4: The system shall complete follow-up tap water monitoring, subsection 10.7.4.2, and source water monitoring, subsection 10.9.3, within 36 months after completion of step 2.

Step 5: The Division shall review the system’s installation and operation of source water treatment and specify maximum permissible source water levels for lead and copper, subsection 10.4.2.4, within 6 months after completion of step 4.

Step 6: The system shall operate in compliance with the Division-specified maximum permissible lead and copper source water levels, subsection 10.4.2.4, and continue source water monitoring, subsection 10.9.4.

10.4.2 Description of Source Water Treatment Requirements:

10.4.2.1 System Treatment Recommendation: Any system which exceeds the lead or copper action level shall recommend in writing to the Division the installation and operation of one of the source water treatments listed in subsection 10.4.2.2. A system may recommend that no treatment be installed based upon a demonstration that source water treatment is not necessary to minimize lead and copper levels at users’ taps.

10.4.2.2 Division Determination Regarding Source Water Treatment: The Division shall complete an evaluation of the results of all source water samples submitted by the water system to determine whether source water treatment is necessary to minimize lead or copper levels in water delivered to users’ taps. If the Division determines that treatment is needed, the Division shall either require installation and operation of the source water treatment recommended by the system (if any) or require the installation and operation of another source water treatment from among the following: ion exchange, reverse osmosis, lime softening or coagulation/filtration. If the Division requests additional information to aid in its review, the water system shall provide the information by the date specified by the Division in its request. The Division shall notify the system in writing of its determination and set forth the basis for its decision.

10.4.2.3 Installation of Source Water Treatment: Each system shall properly install and operate the source water treatment designated by the Division under subsection 10.4.2.2.

10.4.2.4 Division Review of Source Water Treatment and Specification of Maximum Permissible Source Water Levels: The Division shall review the source water samples taken by the water system both before and after the system installs source water treatment, and determine whether the system has properly installed and operated the source water treatment designated by the Division. Based upon its review, the Division shall designate the maximum permissible lead and copper concentrations for finished water entering the distribution system. Such levels shall reflect the contaminant removal capability of the treatment properly operated and maintained. The Division shall notify the system in writing and explain the basis for its decision.

10.4.2.5 Continued Operation and Maintenance: Each water system shall maintain lead and copper levels below the maximum permissible concentrations designated by the Division at each sampling point monitored in accordance with subsection 10.9. The system is out of compliance with this paragraph if the level of lead or copper at any sampling point is greater than the maximum permissible concentration designated by the Division.

10.4.2.6 Modification of Division Treatment Decisions: Upon its own initiative or in response to a request by a water system or other interested party, the Division may modify its determination of the source water treatment under subsection 10.4.2.2, or maximum permissible lead and copper concentrations for finished water entering the distribution system under subsection 10.4.2.4. A request for modification by a system or other interested party shall be in writing, explain why the modification is appropriate, and provide supporting documentation. The Division may modify its determination where it concludes that such change is necessary to ensure that the system continues to minimize lead and copper concentrations in source water. A revised determination shall be made in writing and set forth the new treatment requirements, explain the basis for the Division’s decision and provide an implementation schedule for completing the treatment modifications.

10.4.2.7 EPA Treatment Decisions in Lieu of the Division’s Decisions: The regional administrator may issue federal determinations in lieu of the Division’s determination when:

10.4.2.7.1 The Division fails to issue a determination in a timely manner.

10.4.2.7.2 The Division abuses its discretion in a substantial number of cases or in cases affecting large populations.

10.4.2.7.3 The technical basis of the Division’s decision is indefensible in federal enforcement action(s).

10.5 Lead Service Line Replacement Requirements:

10.5.1 Systems that fail to meet the lead action level in tap samples taken pursuant to subsection 10.7.4.2 after installing corrosion control and/or source water treatment (whichever sampling occurs later) shall replace lead service lines in accordance with the requirements of this section. If a system is in violation of subsections 10.2 or 10.4 for failure to install source water or corrosion control treatment, the Division may require the system to commence lead service line replacement under this section after the date by which the system was required to conduct monitoring under subsection 10.7.4.2 has passed.

10.5.1.1 A system shall replace annually at least 7 percent of the initial number of lead service lines in its distribution system. The initial number of lead service lines is the number of lead lines in place at the time the replacement program begins. The systems shall identify the initial number of lead service lines in its distribution system, including an identification of the portion(s) owned by the system, based upon a materials evaluation, including the evaluation required under subsection 10.7.1 and relevant legal authorities (e.g., contracts, local ordinances) regarding the portion owned by the system. The first year of lead service line replacement shall begin on the first day following the end of the monitoring period in which the action level was exceeded under subsection 10.5.1. If monitoring is required annually or less frequently, the end of the monitoring period is September 30 of the calendar year in which the sampling occurs. If the Division has established an alternate monitoring period, then the end of the monitoring period will be the last day of that period.

10.5.1.2 Any water system resuming a lead service line replacement program after the cessation of its lead service line replacement program as allowed by subsection 10.5.6 shall update its inventory of lead service lines to include those sites that were previously determined not to require replacement through the sampling provision under subsection 10.5.3. The system will then divide the updated number of remaining lead service lines by the number of remaining years in the program to determine the number of lines that must be replaced per year (7 percent lead service line replacement is based on a 15-year replacement program, so, for example, systems resuming lead service line replacement after previously conducting two years of replacement would divide the updated inventory by 13). For those systems that have completed a 15-year lead service line replacement program, the Division will determine a schedule for replacing or retesting lines that were previously tested under the replacement program when the system re-exceeds the action level.

10.5.2 A system is not required to replace an individual lead service line if the lead concentration in all service line samples from that line taken pursuant to subsection 10.7.2.3, is less than or equal to 0.015 mg/L.

10.5.3 A water system shall replace the entire service line (up to the building inlet) unless it demonstrates to the satisfaction of the Division under subsection 10.5.4 that it controls less than the entire service line. In such cases, the system shall replace the portion of the line which the Division determines is under the system’s control. The system shall notify the user served by the line that the system will replace the portion of the service line under its control and shall offer to replace the building owner’s portion of the line, but is not required to bear the cost of replacing the building owner’s portion of the line. For buildings where only a portion of the lead service line is replaced, the water system shall inform the resident(s) that the system will collect a first flush tap water sample after partial replacement of the service line is completed if the resident(s) so desire. In cases where the resident(s) accept the offer, the system shall collect the sample and report the results to the resident(s) within 14 days following partial lead service replacement.

10.5.3.1 At least 45 days prior to commencing with the partial replacement of a lead service line, the water system shall provide notice to the resident(s) of all buildings served by the line explaining that they may experience a temporary increase in lead levels in their drinking water, along with guidance on measures consumers can take to minimize their exposure to lead. The Division may allow the water system to provide notice under the previous sentence less than 45 days prior to commencing partial lead service line replacement where such replacement is in conjunction with emergency repairs. In addition, the water system shall inform the resident(s) served by the line that the system will, at the system’s expense, collect a sample from each partially-replaced lead service line that is representative of the water in the service line for analysis of lead content, as prescribed under subsection 10.7.2.3, within 72 hours after completion of the partial replacement of the service line. The system shall collect the sample and report the results of the analysis to the owner and the resident(s) served by the line within three business days of receiving the results. Mailed notices post-marked within three business days of receiving the results shall be considered “on time.”

10.5.3.2 The water system shall provide the information required by subsection 10.5.3.1 to the residents of individual dwellings by mail or by other methods approved by the Division. In instances where multi-family dwellings are served by the line, the water system shall have the option to post the information at a conspicuous location.

10.5.4 A water system is presumed to control the entire lead service line (up to the building inlet) unless the system demonstrates to the satisfaction of the Division, in a letter submitted under subsection 10.10.5.4, that it does not have any of the following forms of control over the entire line (as defined by Division statutes, municipal ordinances, public service contracts or other applicable legal authority); authority to set standards for construction, repair, or maintenance of the line, authority to replace, repair, or maintain the service line, or ownership of the service line. The Division shall review the information supplied by the system and determine whether the system controls less than the entire service line, in such cases, shall determine the extent of the system’s control. The Division’s determination shall be in writing and explain the basis for its decision.

10.5.5 The Division shall require a system to replace lead service lines on a shorter schedule than that required by this section, taking into account the number of lead service lines in the system, where such a shorter replacement schedule is feasible. The Division shall make this determination in writing and notify the system of its finding within 6 months after the system is triggered into lead service line replacement based on monitoring referenced in subsection 10.5.1.

10.5.6 Any system may cease replacing lead service lines whenever first draw samples collected pursuant to subsection 10.7.2.2 meet the lead action level during each of two consecutive monitoring periods and the system submits the results to the Division. If the first draw samples in any such water system thereafter exceeds the lead action level, the system shall recommence replacing lead service lines, pursuant to subsection 10.5.1.2.

10.5.7 To demonstrate compliance with subsections 10.5.1 through 10.5.4, a system shall report to the Division the information specified in subsection 10.10.5.

10.6 Public education and supplemental monitoring requirements. All water systems must deliver a consumer notice of lead tap water monitoring results to persons served by the water system at sites that are tested, as specified in subsection 10.6.4. A water system that exceeds the lead action level based on tap water samples collected in accordance with subsection 10.7 shall deliver the public education materials contained in subsection 10.6.1 in accordance with the requirements of subsection 10.6.2. Water systems that exceed the lead action level must sample the tap water of any customer who requests it in accordance with subsection 10.6.3.

10.6.1 Content of written public education materials.

10.6.1.1 Community water systems and non-transient non-community water systems. Water systems must include the following elements in printed materials (e.g., brochures and pamphlets) in the same order as listed below. In addition, language in subsections 10.6.1.1.1 through 10.6.1.1.2 and 10.6.1.1.6 must be included in the materials, exactly as written, except for the text in brackets in these sections for which the water system must include system-specific information. Any additional information presented by a water system must be consistent with the information below and be in plain language that can be understood by the general public. Water systems must submit all written public education materials to the Division prior to delivery. The Division may require the system to obtain approval of the content of written public materials prior to delivery.

10.6.1.1.1 IMPORTANT INFORMATION ABOUT LEAD IN YOUR DRINKING WATER [INSERT NAME OF WATER SYSTEM] found elevated levels of lead in drinking water in some homes/buildings. Lead can cause serious health problems, especially for pregnant women and young children. Please read the information closely to see what you can do to reduce lead in your drinking water.

10.6.1.1.2 Health effects of lead. Lead can cause serious health problems if too much enters your body from drinking water or other sources. It can cause damage to the brain and kidneys, and can interfere with the production of red blood cells that carry oxygen to all parts of your body. The greatest risk of lead exposure is to infants, young children, and pregnant women. Scientists have linked the effects of lead on the brain with lowered IQ in children. Adults with kidney problems and high blood pressure can be affected by low levels of lead more than healthy adults. Lead is stored in the bones, and it can be released later in life. During pregnancy, the child receives lead from the mother’s bones, which may affect development.

10.6.1.1.3 Sources of lead.

10.6.1.1.3.1 Explain what lead is.

10.6.1.1.3.2 Explain possible sources of lead in drinking water and how lead enters drinking water. Include information on home/building plumbing materials and service lines that may contain lead.

10.6.1.1.3.3 Discuss other important sources of lead exposure in addition to drinking water (e.g., paint).

10.6.1.1.4 Discuss the steps the consumer can take to reduce their exposure to lead in drinking water.

10.6.1.1.4.1 Encourage running the water to flush out the lead.

10.6.1.1.4.2 Explain the concerns with using hot water from the tap and specifically caution against use of hot water for preparing baby formula.

10.6.1.1.4.3 Explain that boiling water does not reduce lead levels.

10.6.1.1.4.4 Discuss other options consumers can take to reduce exposure to lead in drinking water, such as alternative sources or treatment of water.

10.6.1.1.4.5 Suggest that parents have their child’s blood tested for lead.

10.6.1.1.5 Explain why there are elevated levels of lead in the system’s drinking water (if known) and what the water system is doing to reduce the lead levels in homes/buildings in this area.

10.6.1.1.6 For more information, call us at [INSERT YOUR PHONE NUMBER] [(IF APPLICABLE), or visit our website at [INSERT YOUR WEBSITE HERE)]. For more information on reducing lead exposure around your home/building and the health effects of lead, visit EPA’s Web site at http://www.epa.gov/lead or contact your health care provider.

10.6.1.2 Community water systems. In addition to including the elements specified in subsection 10.6.1.1 community water systems must:

10.6.1.2.1 Tell consumers how to get their water tested.

10.6.1.2.2 Discuss lead in plumbing components and the difference between low lead and lead free.

10.6.2 Delivery of public education material.

10.6.2.1 For public water systems serving a large proportion of non-English speaking consumers, as determined by the Division, the public education materials must contain information in the appropriate language(s) regarding the importance of the notice or contain a telephone number or address where persons served may contact the water system to obtain a translated copy of the public education materials or to request assistance in the appropriate language.

10.6.2.2 A community water system that exceeds the lead action level on the basis of tap water samples collected in accordance with subsection 10.7, and that is not already conducting public education tasks under this section, must conduct the public education tasks under this section within 60 days after the end of the monitoring period in which the exceedance occurred:

10.6.2.2.1 Deliver printed materials meeting the content requirements of subsection 10.6.1 to all bill paying customers.

10.6.2.2.1.1 Contact customers who are most at risk by delivering education materials that meet the content requirements of subsection 10.6.1 to local public health agencies even if they are not located within the water system’s service area, along with an informational notice that encourages distribution to all the organization’s potentially affected customers or community water system’s users. The water system must contact the local public health agencies directly by phone or in person. The local public health agencies may provide a specific list of additional community based organizations serving target populations, which may include organizations outside the service area of the water system. If such lists are provided, systems must deliver education materials that meet the content requirements of subsection 10.6.1 to all organizations on the provided lists.

10.6.2.2.1.2 Contact customers who are most at risk by delivering materials that meet the content requirements of subsection 10.6.1 to the following organizations listed in subsection 10.6.2.2.2.2.1 through 10.6.2.2.2.2.6 that are located within the water system’s service area, along with an informational notice that encourages distribution to all the organization’s potentially affected customers or community water system’s users:

10.6.2.2.1.2.1 Public and private schools or school boards.

10.6.2.2.1.2.2 Women, Infants and Children (WIC) and Head Start Programs.

10.6.2.2.1.2.3 Public and private hospitals and medical clinics.

10.6.2.2.1.2.4 Pediatricians.

10.6.2.2.1.2.5 Family planning clinics.

10.6.2.2.1.2.6 Local welfare agencies.

10.6.2.2.1.3 Make a good faith effort to locate the following organizations within the service area and deliver materials that meet the content requirements of subsection 10.6.1 to them, along with an informational notice that encourages distribution to all potentially affected customers or users. The good faith effort to contact at-risk customers may include requesting a specific list of these organizations from the local public health agencies, even if the agencies are not located within the water system’s service area:

10.6.2.2.1.3.1 Licensed childcare centers

10.6.2.2.1.3.2 Public and private preschools

10.6.2.2.1.3.3 Obstetricians-Gynecologists and Midwives.

10.6.2.2.2 [Reserved]

10.6.2.2.3 No less often than quarterly, provide information on or in each water bill as long as the system exceeds the action level for lead. The message on the water bill must include the following statement exactly as written except for the text in brackets for which the water system must include system-specific information: [INSERT NAME OF WATER SYSTEM] found high levels of lead in drinking water in some homes. Lead can cause serious health problems. For more information please call [INSERT NAME OF WATER SYSTEM] [or visit (INSERT YOUR WEBSITE HERE)] The message or delivery mechanism can be modified in consultation with the Division; specifically, the Division may allow a separate mailing of public education materials to customers if the water system cannot place the information on water bills.

10.6.2.2.4 Post material meeting the content requirements of subsection 10.6.1 on the water system’s website if the system serves a population greater than 100,000.

10.6.2.2.5 Submit a press release to newspaper, television and radio stations.

10.6.2.2.6 In addition to subsections 10.6.2.2.1 through 10.6.2.2.5, systems must implement at least three activities from one or more of the categories listed below. The educational content and selection of these activities must be determined in consultation with the Division.

10.6.2.2.6.1 Public Service Announcements.

10.6.2.2.6.2 Paid advertisements.

10.6.2.2.6.3 Public Area Information Displays.

10.6.2.2.6.4 Emails to customers.

10.6.2.2.6.5 Public meetings.

10.6.2.2.6.6 Household deliveries.

10.6.2.2.6.7 Targeted individual customer contact.

10.6.2.2.6.8 Direct material distribution to all multi-family homes and institutions.

10.6.2.2.6.9 Other methods approved by the Division.

10.6.2.2.7 For systems that are required to conduct monitoring annually or less frequently, the end of the monitoring period is September 30 of the calendar year in which the sampling occurs, or, if the Division has established an alternative monitoring period, the last day of that period.

10.6.2.3 As long as a community water system exceeds the action level, it must repeat the activities pursuant to subsection 10.6.2.2 as described in subsections 10.6.2.3.1 through 10.6.2.3.4.

10.6.2.3.1 A community water system shall repeat the tasks contained in subsections 10.6.2.2.1, 10.6.2.2.2 and 10.6.2.2.6 every 12 months.

10.6.2.3.2 A community water system shall repeat the tasks contained in subsection 10.6.2.2.3 with every billing cycle.

10.6.2.3.3 A community water system serving a population greater than 100,000 shall post and retain material on a publicly accessible website pursuant to subsection 10.6.2.2.4.

10.6.2.3.4 The community water system shall repeat the task in subsection 10.6.2.2.5 twice every 12 months on a schedule agreed upon with the Division. The Division can allow activities in subsection 10.6.2.2 to extend beyond the 60-day requirement if needed for implementation purposes on a case-by-case basis; however, this extension must be approved in writing by the Division in advance of the 60-day deadline.

10.6.2.4 Within 60 days after the end of the monitoring period in which the exceedance occurred (unless it already is repeating public education tasks pursuant to subsection 10.6.2.5), a non-transient non-community water system shall deliver the public education materials specified by subsection 10.6.1 as follows:

10.6.2.4.1 Post informational posters on lead in drinking water in a public place or common area in each of the buildings served by the system; and

10.6.2.4.2 Distribute informational pamphlets and/or brochures on lead in drinking water to each person served by the non-transient non-community water system. The Division may allow the system to utilize electronic transmission in lieu of or combined with printed materials as long as it achieves at least the same coverage.

10.6.2.4.3 For systems that are required to conduct monitoring annually or less frequently, the end of the monitoring period is September 30 of the calendar year in which the sampling occurs, or, if the Division has established an alternate monitoring period, the last day of that period.

10.6.2.5 A non-transient non-community water system shall repeat the tasks contained in subsection 10.6.2.4 at least once during each calendar year in which the system exceeds the lead action level. The Division can allow activities in subsection 10.6.2.4 to extend beyond the 60-day requirement if needed for implementation purposes on a case-by-case basis; however, this extension must be approved in writing by the Division in advance of the 60-day deadline.

10.6.2.6 A water system may discontinue delivery of public education materials if the system has met the lead action level during the most recent six-month monitoring period conducted pursuant to subsection 10.7. Such a system shall recommence public education in accordance with this section if it subsequently exceeds the lead action level during any monitoring period.

10.6.2.7 A community water system may apply to the Division, in writing (unless the Division has waived the requirement for prior Division approval), to use only the text specified in subsection 10.6.1.1 in lieu of the text in subsections 10.6.1.1 and 10.6.1.2 and to perform the tasks listed in subsections 10.6.2.4 and 10.6.2.5 in lieu of the tasks listed in subsections 10.6.2.2 and 10.6.2.3 if:

10.6.2.7.1 The system is a facility, such as a prison or a hospital, where the population served is not capable of or is prevented from making improvements to plumbing or installing point of use treatment devices; and,

10.6.2.7.2 The system provides water as part of the cost of services provided and does not separately charge for water consumption.

10.6.2.8 A community water system serving 3,300 or fewer people may limit certain aspects of their public education programs as follows:

10.6.2.8.1 With respect to the requirements of subsection 10.6.2.2.6, a system serving 3,300 or fewer people must implement at least one of activities listed in that section.

10.6.2.8.2 With respect to the requirements of subsection 10.6.2.2.2, a system serving 3,300 or fewer people may limit the distribution of the public education materials required under that section to facilities and organizations served by the system that are most likely to be visited regularly by pregnant women and children.

10.6.2.8.3 With respect to the requirements of subsection 10.6.2.2.5, the Division may waive this requirement for systems serving 3,300 or fewer people as long as the system distributes notices to every household served by the system.

10.6.3 Supplemental monitoring and notification of results. A water system that fails to meet the lead action level on the basis of tap samples collected in accordance with section 10.7 shall offer to sample the tap water of any customer who requests it. The system is not required to pay for collecting or analyzing the sample, nor is the system required to collect and analyze the sample itself.

10.6.4 Notification of results.

10.6.4.1 Reporting requirement. All water systems must provide a notice of the individual tap results from the lead tap water monitoring carried out under the requirements of 107 to the persons served by the water system at the specific sample site from which the sample was taken (e.g., the occupants of the residence where the tap was tested).

10.6.4.2 Timing of notification. A water system must provide the consumer notice as soon as practical, but no later than 30 days after the system learns of the tap monitoring results.

10.6.4.3 Content. The consumer notice must include the results of the lead tap water monitoring for the tap that was tested, an explanation of the health effects of lead, list steps consumers can take to reduce exposure to lead in drinking water and contact information for the water utility. The notice must also provide the maximum contaminant level goal and the action level for lead and the definitions for those terms from subsection 6.3.3.

10.6.4.4 Delivery. The consumer notice must be provided to persons served at the tap that was tested, either by mail or by another method approved by the Division. For example, upon approval by the Division, a non-transient non-community water system could post the results on a bulletin board in the facility to allow users to review the information. The system must provide the notice to customers at sample taps tested, including consumers who do not receive water bills.

10.7 Monitoring Requirements for Lead and Copper in Tap Water:

10.7.1 Sample Site Location:

10.7.1.1 By the applicable date for commencement of monitoring under subsection 10.7.4.1, each water system shall complete a materials evaluation of its distribution system in order to identify a pool of targeted sampling sites that meets the requirements of this section, and which is sufficiently large enough to ensure that the water system can collect the number of lead and copper tap samples required in subsection 10.7.3. All sites from which first draw samples are collected shall be selected from this pool of targeted sampling sites. Sampling sites may not include faucets that have point-of-use or point-of-entry treatment devices designed to remove inorganic contaminants.

10.7.1.2 A water system shall use the information on lead, copper, and galvanized steel that is required to collect under subsection 11.1.4 of these regulations (special monitoring for corrosivity characteristics) when conducting a materials evaluation. When an evaluation of the information collected pursuant to subsection 11.1.4 is insufficient to locate the requisite number of lead and copper sampling sites that meet the targeting criteria in subsection 10.7.1, the water system shall review the sources of information listed below in order to identify a sufficient number of sampling sites. In addition, the system shall seek to collect such information where possible in the course of its normal operations (e.g., checking service line materials when reading water meters or performing maintenance activities):

10.7.1.2.1 All plumbing codes, permits, and records in the files of the building department(s) which indicate the plumbing materials that are installed within publicly and privately owned structures connected to the distribution system;

10.7.1.2.2 All inspections and records of the distribution system that indicate the material composition of the service connections that connect a structure to the distribution system; and

10.7.1.2.3 All existing water quality information, which includes the results of all prior analyses of the system or individual structures connected to the system, indicating locations that may be particularly susceptible to high lead or copper concentrations.

10.7.1.3 The sampling sites selected for a community water system’s sampling pool (“tier 1 sampling sites”) shall consist of single family structures that:

10.7.1.3.1 Contain copper pipes with lead solder installed after 1982 or contain lead pipes; and/or

10.7.1.3.2 Are served by a lead service line. When multiple-family residences comprise at least 20 percent of the structures served by a water system, the system may include these types of structures in its sampling pool.

10.7.1.4 Any community water system with insufficient tier 1 sampling sites shall complete its sampling pool with “tier 2 sampling sites”, consisting of buildings, including multiple-family residences that:

10.7.1.4.1 Contain copper pipes with lead solder installed after 1982 or contain lead pipes; and/or

10.7.1.4.2 Are served by a lead service line.

10.7.1.5 Any community water system with insufficient tier 1 and tier 2 sampling sites shall complete its sampling pool with “tier 3 sampling sites”, consisting of single family structures that contain copper pipes with lead solder installed before 1983. A community water system with insufficient tier 1, tier 2, and tier 3 sampling sites shall complete its sampling pool with representative sites throughout the distribution system. For the purpose of this paragraph, a representative site is a site in which the plumbing materials used at that site would be commonly found at other sites served by the system.

10.7.1.6 The sampling sites selected for a non-transient non-community water system (“tier 1 sampling sites”) shall consist of buildings that:

10.7.1.6.1 Contain copper pipes with lead solder installed after 1982 or contain lead pipes; and/or

10.7.1.6.2 Are served by a lead service line.

10.7.1.7 A non-transient non-community water system with insufficient tier 1 sites that meet the targeting criteria in subsection 10.7.1.6 shall complete its sampling pool with tier 2 sampling sites that contain copper pipes with lead solder installed before 1983. If additional sites are needed to complete the sampling pool, the non-transient non-community water system shall use representative sites throughout the distribution system. For the purpose of this paragraph, a representative site is a site in which the plumbing materials used at that site would be commonly found at other sites served by the water system.

10.7.1.8 Any water system whose distribution system contains lead service lines shall draw 50 percent of the samples it collects during each monitoring period from sites that contain lead pipes, or copper pipes with lead solder, and 50 percent of those samples from sites served by a lead service line. A water system that cannot identify a sufficient number of sampling sites served by a lead service line shall collect first-draw samples from all of the sites identified as being served by such lines.

10.7.2 Sample Collection Methods:

10.7.2.1 All tap samples for lead and copper collected in accordance with this section, with the exception of lead service line samples collected under subsection 10.5.3 and samples collected under subsection 10.7.2.5, shall be first draw samples.

10.7.2.2 Each first-draw tap sample for lead and copper shall be one liter in volume and have stood motionless in the plumbing system of each sampling site for at least six hours. First-draw samples from residential housing shall be collected from the cold-water kitchen tap or bathroom sink tap. First-draw samples from a non-residential building shall be one liter in volume and shall be collected at an interior tap from which water is typically drawn for consumption. Non-first-draw samples collected in lieu of first-draw samples pursuant to subsection 10.7.2.5 shall be one liter in volume and shall be collected at an interior tap from which water is typically drawn for consumption. First-draw samples may be collected by the system or the system may allow residents to collect first-draw samples after instructing the residents of the sampling procedures specified in this paragraph. To avoid problems of residents handling nitric acid, acidification of first-draw samples may be done up to 14 days after the sample is collected. After acidification to resolubilize the metals, the sample must stand in the original container for the time specified in the approved EPA method before the sample can be analyzed. If a system allows residents to perform sampling, the system may not challenge, based on the alleged errors in sample collection, the accuracy of sampling results.

10.7.2.3 Each service line sample shall be one liter in volume and have stood motionless in the lead service line for at least six hours. Lead service line samples shall be collected in one of the following three ways:

10.7.2.3.1 At the tap after flushing the volume of water between the tap and the lead service line. The volume of water shall be calculated based on the interior diameter and length of the pipe between the tap and the lead service line;

10.7.2.3.2 Tapping directly into the lead service line; or

10.7.2.3.3 If the sampling site is a building constructed as a single-family residence, allowing the water to run until there is a significant change in temperature which would be indicative of water that has been standing in the lead service line.

10.7.2.4 A water system shall collect each first-draw tap sample from the same sampling site from which it collected a previous sample. If, for any reason, the water system cannot gain entry to a sampling site in order to collect a follow-up tap sample, the system may collect the follow-up tap sample from the pool as long as the new site meets the same targeting criteria, and is within reasonable proximity of the original site.

10.7.2.5 A non-transient non-community water system, or a community water system that meets the criteria of subsection 10.6.2.7 that does not have enough taps that can supply first-draw samples as defined in subsection 10.7.2.2, may apply to the Division in writing to substitute non-first-draw samples. Such systems must collect as many first-draw samples from appropriate taps as possible and identify sampling times and locations that would likely result in the longest standing time for the remaining sites. The Division has the discretion to waive the requirement for prior Division approval of non-first-draw sample sites selected by the system, either through regulation or written notification to the system.

10.7.2.6 Invalidation of lead and copper tap samples. A sample invalidated under this paragraph does not count toward determining lead or copper 90th percentile levels under subsection 10.1.3.3 or toward the minimum monitoring requirements of subsection 10.7.3.

10.7.2.6.1 The Division may invalidate a lead or copper tap sample at least if one of the following conditions is met.

10.7.2.6.1.1 The laboratory establishes that improper sample analysis caused erroneous results.

10.7.2.6.1.2 The Division determines that the sample was taken from a site that did not meet the site selection criteria of this section.

10.7.2.6.1.3 The sample container was damaged in transit.

10.7.2.6.1.4 There is substantial reason to believe that the sample was subject to tampering.

10.7.2.6.2 The system must report the results of all samples to the Division and all supporting documentation for samples the systems believes should be invalidated.

10.7.2.6.3 To invalidate a sample under subsection 10.7.2.6.1 the decision and the rationale for the decision must be documented in writing. The Division may not invalidate a sample solely on the grounds that a follow-up sample result is higher or lower than that of the original sample.

10.7.2.6.4 The system must collect replacement samples for any samples invalidated under this section if, after the invalidation of one or more samples, the system has too few samples to meet the minimum requirements of subsection 10.7.3. Any such replacement samples must be taken as soon as possible, but no later than 20 days after the date the Division invalidates the sample or by the end of the applicable monitoring period, whichever occurs later. Replacement samples taken after the end of the applicable monitoring period shall not also be used to meet the monitoring requirements of a subsequent monitoring period. The replacement samples shall be taken at the same locations as the invalidated samples or, if that is not possible, at locations other than those already used for sampling during the monitoring period.

10.7.3 Number of Samples: Water systems shall collect at least one sample during each monitoring period specified in subsection 10.7.4 from the number of sites listed in the second column below (“standard monitoring”). A system conducting reduced monitoring under subsection 10.7.4.4 shall collect one sample from the number of sites specified in the third column (“reduced monitoring”) below during each monitoring period specified in subsection 10.7.4.4. Such reduced monitoring sites shall be representative of the sites required for standard monitoring. A public water system that has fewer than five drinking water taps, that can be used for human consumption meeting the sample site criteria of subsection 10.7.1 to reach the required number of sample sites listed in subsection 10.7.3, must collect at least one sample from each tap and then must collect additional samples from those taps on different days during the monitoring period to meet the required number of sites. Alternatively the Division may allow these public water systems to collect a number of samples less than the number of sites specified in subsection 10.7.3, provided that 100 percent of all taps that can be used for human consumption are sampled. The Division must approve this reduction of the minimum number of samples in writing based on a request from the system or onsite verification by the Division. The Division may specify sampling locations when a system is conducting reduced monitoring. The table is as follows:

10.7.4 Timing of Monitoring:

10.7.4.1 Initial Tap Sampling: The first six-month monitoring period for small, medium-size and large systems shall begin on the following dates:

10.7.4.1.1 All large systems shall monitor during two consecutive six-month periods.

10.7.4.1.2 All small and medium-size systems shall monitor during each six-month monitoring period until:

10.7.4.1.2.1 The system exceeds the lead or copper action level and is therefore required to implement the corrosion control treatment requirements under subsection 10.2 in which case the system shall continue monitoring in accordance with subsection 10.7.4.2, or

10.7.4.1.2.2 The system meets the lead and copper action levels during two consecutive six-month monitoring periods, in which case the system may reduce monitoring in accordance with subsection 10.7.4.4.

10.7.4.2 Monitoring after Installation of Corrosion Control and Source Water Treatment:

10.7.4.2.1 Any large system which installs optimal corrosion control treatment pursuant to subsection 10.2.4 Step 4 shall monitor during two consecutive six-month periods by the date specified in subsection 10.2.4 Step 5.

10.7.4.2.2 Any small or medium-size system which installs optimal corrosion control treatment pursuant to subsection 10.2.5 Step 5 shall monitor during two consecutive six-month periods by the date specified in subsection 10.2.5 Step 6.

10.7.4.2.3 Any system which installs source water treatment pursuant to subsection 10.4.1 Step 3 shall monitor during two consecutive six-month periods by the date specified in subsection 10.4.1 Step 4.

10.7.4.3 Monitoring after Division specifies Water Quality Parameter Values for Optimal Corrosion Control: After the Division specifies the values for water quality control parameters under subsection 10.3.6, the system shall monitor during each subsequent six-month monitoring period, with the first monitoring period to begin on the date the Division specifies the optimal values under subsection 10.3.6.

10.7.4.4 Reduced Monitoring:

10.7.4.4.1 A small or medium-size water system that meets the lead and copper action levels during each of two consecutive six-month monitoring periods may reduce the number of samples in accordance with subsection 10.7.3, and reduce the frequency of sampling to once per year. A small or medium water system collecting fewer than five samples as specified in subsection 10.7.3, that meets the lead and copper action levels during each of two consecutive six-month monitoring periods may reduce the frequency of sampling to once per year. In no case can the system reduce the number of samples required below the minimum of one sample per available tap. This sampling shall begin during the calendar year immediately following the end of the second consecutive six-month monitoring period.

10.7.4.4.2 Any water system that meets the lead action level and maintains the range of values for the water quality control parameters reflecting optimal corrosion control treatment specified by the Division under subsection 10.3.6 during each of two consecutive six-month monitoring periods may reduce the frequency of monitoring to once per year and to reduce the number of lead and copper samples in accordance with subsection 10.7.3 if it receives written approval from the Division. This sampling shall begin during the calendar year immediately following the end of the second consecutive six-month monitoring period. The Division shall review monitoring, treatment and other relevant information submitted by the water system in accordance with subsection 10.10, and shall notify the system in writing when it determines the system is eligible to commence reduced monitoring pursuant to this paragraph. The Division shall review, and where appropriate, revise its determination when the system submits new monitoring or treatment data, or when other data relevant to the number and frequency of tap sampling becomes available.

10.7.4.4.3 A small or medium-size water system that meets the lead and copper action levels during three consecutive years of monitoring may reduce the frequency of monitoring for lead and copper from annually to once every three years. Any water system that meets the lead action level and maintains the range of values for the water quality control parameters reflecting optimal corrosion control treatment specified by the Division under subsection 10.3.6 during three consecutive years of monitoring may reduce the frequency of monitoring from annually to once every three years if it receives written approval from the Division. Samples collected once every three years shall be collected no later than every third calendar year. The Division shall review monitoring, treatment and other relevant information submitted by the water system in accordance with subsection 10.10 and shall notify the system in writing when it determines the system is eligible to reduce the frequency of monitoring to once every three years. The Division shall review, and where appropriate, revise its determination when the system submits new monitoring or treatment data, or when other data relevant to the number and frequency of tap sampling becomes available.

10.7.4.4.4 A water system that reduces the number and frequency of sampling shall collect these samples from sites included in the pool of targeted sampling sites identified in subsection 10.7.1. Systems sampling annually or less frequently shall conduct the lead and copper tap sampling during the months of June, July, August or September unless the Division has approved a different sampling period in accordance with subsection 10.7.4.4.4.1.

10.7.4.4.4.1 The Division, at its discretion, may approve a different period for conducting the lead and copper tap sampling for systems collecting a reduced number of samples. Such a period shall be no longer than four consecutive months and must represent a time of normal operation where the highest levels of lead are most likely to occur. For a non-transient non-community water system that does not operate during the months of June through September, and for which the period of normal operation where the highest levels of lead are most likely to occur is not known, the Division shall designate a period that represents a time of normal operation for the system. This sampling shall begin during the period approved or designated by the Division in the calendar year immediately following the end of the second consecutive six-month monitoring period for systems initiating annual monitoring and during the three-year period following the end of the third consecutive calendar year of annual monitoring for systems initiating triennial monitoring.

10.7.4.4.4.2 Systems monitoring annually, that have been collecting samples during the months of June through September and that receive Division approval to alter their sample collection period under subsection 10.7.4.4.4.1, must collect their next round of samples during a time period that ends no later than 21 months after the previous round of sampling. Systems monitoring triennially that have been collecting samples during the months of June through September, and receive Division approval to alter the sampling collection period as per subsection 10.7.4.4.4.1, must collect their next round of samples during a time period that ends no later than 45 months after the previous round of sampling. Subsequent rounds of sampling must be collected annually or triennially, as required by this subsection. Small systems with waivers, granted pursuant to subsection 10.7.6, that have been collecting samples during the months of June through September and receive Division approval to alter their sample collection period under subsection 10.7.4.4.4.1 must collect their next round of samples before the end of the 9-year period.

10.7.4.4.5 Any water system that demonstrates for two consecutive 6-month monitoring periods that the tap water lead level computed under subsection 10.1.3.3 is less than or equal to 0.005 mg/L and the tap water copper level computed under subsection 10.1.3.3 is less than or equal to 0.65 mg/L may reduce the number of samples in accordance with subsection 10.7.3 and reduce the frequency of sampling to once every three calendar years.

10.7.4.4.6 Return to standard monitoring after failure to meet action levels or operate within specified water quality parameters.

10.7.4.4.6.1 A small or medium-size water system subject to reduced monitoring that exceeds the lead or copper action levels shall resume sampling in accordance with subsection 10.1.3.3 and collect the number of samples specified for standard monitoring under subsection 10.7.3. Such a system shall also conduct water quality parameter monitoring in accordance with subsections 10.8.2, 10.8.3 or 10.8.4 (as appropriate) during the monitoring period in which it exceeded the action level. Any such system may resume annual monitoring for lead and copper at the tap at the reduced number of sites specified in subsection 10.7.3 after it has completed two subsequent consecutive 6-month rounds of monitoring that meet the requirements of subsection 10.7.4.4.1 and/or may resume triennial monitoring for lead and copper at the reduced number of sites after it demonstrates through subsequent rounds of monitoring that it meets the criteria of either subsection 10.7.4.4.3 or 10.7.4.4.5.

10.7.4.4.6.2 Any water system subject to reduced monitoring frequency that fails to meet the lead action level during any four-month monitoring period or that fails to operate at or above the minimum value or within the range of values for the water quality control parameters specified by the Division under subsection 10.3.6 for more than nine days in any 6-month period specified in subsection 10.8.4 shall conduct tap water sampling for lead and copper at the frequency specified in subsection 10.7.4.3, collect the number of samples specified for standard monitoring under subsection 10.7.3, and shall resume monitoring for water quality parameters within the distribution system in accordance with subsection 10.8.4. This standard tap water sampling shall begin no later than the six-month period beginning January 1 of the calendar year following the lead action level exceedance or water quality parameter excursion. Such a system may resume reduced monitoring for lead and copper at the tap and for water quality parameters within the distribution system under the following conditions:

10.7.4.4.6.2.1 The system may resume annual monitoring for lead and copper at the tap at the reduced number of sites specified in subsection 10.7.3 after it has completed two subsequent 6-month rounds of monitoring that meet the criteria of subsection 10.7.4.4.2 and the system has received written approval from the Division that it is appropriate to resume reduced monitoring on the annual frequency. This sampling shall begin during the calendar year immediately following the end of the second consecutive six-month monitoring period.

10.7.4.4.6.2.2 The system may resume triennial monitoring for lead and copper at the tap at the reduced number of sites after it demonstrates through subsequent rounds of monitoring that it meets the criteria of either subsections 10.7.4.4.3 or 10.7.4.4.5 and the system has received written approval from the Division that it is appropriate to resume triennial monitoring.

10.7.4.4.6.2.3 The system may reduce the number of water quality parameter tap water samples required in accordance with subsection 10.8.5.1 and the frequency with which it collects such samples in accordance with subsection 10.8.5.2. Such a system may not resume triennial monitoring for water quality parameters at the tap until it demonstrates, in accordance with the requirements of subsection 10.8.5.2, that it has re-qualified for triennial monitoring.

10.7.4.4.7 Any water system subject to a reduced monitoring frequency under subsection 10.7.4.4 shall notify the Division in writing in accordance with subsection 10.10.1.3 of any upcoming long-term change in treatment or addition of a new source as described in that section. The Division must review and approve the addition of a new source or long-term change in water treatment before it is implemented by the water system. The Division may require the system to resume sampling in accordance with subsection 10.7.4.3 and collect the number of samples specified for standard monitoring under subsection 10.7.3 or take other appropriate steps such as increased water quality parameter monitoring or re-evaluation of its corrosion control treatment given the potentially different water quality considerations.

10.7.5 Additional Monitoring by Systems: The results of any monitoring conducted in addition to the minimum requirements of this subsection shall be considered by the system and the Division in making any determinations (i.e., calculating the 90th percentile lead or copper level) under this section.

10.7.6 Monitoring Waivers for Small Systems: Any small system that meets the criteria of this paragraph may apply to the Division to reduce the frequency of monitoring for lead and copper under this section to once every nine years (i.e., a “full waiver”) if it meets all of the materials criteria specified in section 10.7.6.1 and all of the monitoring criteria specified in subsection 10.7.6.2. If Division regulations permit, any small system that meets the criteria in subsections 10.7.6.1 and 10.7.6.2 only for lead, or only for copper, may apply to the Division for a waiver to reduce the frequency of tap water monitoring to once every nine years for that contaminant only (i.e., a “partial waiver”).

10.7.6.1 Materials Criteria: The system must demonstrate that its distribution system and service lines and all drinking water supply plumbing, including plumbing conveying drinking water within all residences and buildings connected to the system, are free of lead-containing materials and/or copper-containing materials, as those terms are defined in this paragraph, as follows:

10.7.6.1.1 Lead. To qualify for a full waiver, or a waiver of the tap water monitoring requirements for lead (i.e., a “lead waiver”), the water system must provide certification and supporting documentation to the Division that the system is free of all lead-containing materials as follows:

10.7.6.1.1.1 It contains no plastic pipe which contain lead plasticizers, or plastic service lines which contain lead plasticizers; and

10.7.6.1.1.2 It is free of lead service lines, lead pipes, lead soldered pipe joints, and leaded brass or bronze alloy fittings and fixtures, unless such fittings and fixtures meet the specifications of any standard established pursuant to 42 U.S.C. 300g-6(e) (Safe Drinking Water Act section 1417(e)).

10.7.6.1.2 Copper. To qualify for a full waiver, or a waiver of the tap water monitoring requirements for copper (i.e., a “copper waiver”), the water system must provide certification and supporting documentation to the Division that the system contains no copper pipes or copper service lines.

10.7.6.2 Monitoring Criteria for Waiver Issuance: The system must have completed at least one six-month round of standard tap water monitoring for lead and copper at sites approved by the Division and from the number of sites required by subsection 10.7.3 and demonstrate that the 90th percentile levels for any and all rounds of monitoring conducted since the system became free of all lead-containing and/or copper-containing materials, as appropriate, meet the following criteria.

10.7.6.2.1 Lead levels. To qualify for a full waiver, or a lead waiver, the system must demonstrate that the 90th percentile lead level does not exceed 0.005 mg/L.

10.7.6.2.2 Copper levels. To qualify for a full waiver, or a copper waiver, the system must demonstrate that the 90th percentile copper level does not exceed 0.65 mg/L.

10.7.6.3 Division Approval of Waiver Application: The Division shall notify the system of its waiver determination, in writing, setting forth the basis of its decision and any condition of the waiver. As a condition of the waiver, the Division may require the system to perform specific activities (e.g., limited monitoring, periodic outreach to customers to remind them to avoid installation of materials that void the waiver) to avoid the risk of lead or copper concentration of concern in tap water. The small system must continue monitoring for lead and copper at the tap as required by subsections 10.7.4.1 through 10.7.4.4, as appropriate, until it receives written notification from the Division that the waiver has been approved.

10.7.6.4 Monitoring frequency for systems with waivers.

10.7.6.4.1 A system with a full waiver must conduct tap water monitoring for lead and copper in accordance with subsection 10.7.4.4.4 at the reduced number of sampling sites identified in subsection 10.7.3 at least once every nine years and provide the materials certification specified in subsection 10.7.6.1 for both lead and copper to the Division along with the monitoring results. Samples collected every nine years shall be collected no later than every ninth calendar year.

10.7.6.4.2 A system with a partial waiver must conduct tap water monitoring for the waived contaminant in accordance with subsection 10.4.4.4 at the reduced number of sample sites specified in subsection 10.7.3 at least once every nine years and provide the materials certification specified in subsection 10.7.6.1 pertaining to the waived contaminant along with the monitoring results. Such a system also must continue to monitor for the non-waived contaminant in accordance with subsections 10.7.4.1 through 10.7.4.4, as appropriate.

10.7.6.4.3 Any water system with a full or partial waiver shall notify the Division in writing in accordance with subsection 10.10.1.3 of any upcoming long-term change in treatment or addition of a new source, as described in that subsection. The Division must review and approve the addition of a new source or long-term change in water treatment before it is implemented by the water system. The Division has the authority to require the system to modify waiver conditions (e.g., require re-certification that the system is free of lead-containing and/or copper-containing materials or require additional round(s) of monitoring), if it deems such modifications are necessary to address treatment or source water changes at the system.

10.7.6.4.4 If a system with a full or partial waiver becomes aware that it is no longer free of lead-containing or copper-containing materials, as appropriate, (e.g., as a result of new construction or repairs), the system shall notify the Division in writing no later than 60 days after becoming aware of such a change.

10.7.6.5 Continued Eligibility: If the system continues to satisfy the requirements of subsection 10.7.6.4, the waiver will be renewed automatically, unless any of the conditions listed in subsections 10.7.6.5.1 through 10.7.6.5.3 occurs. A system whose waiver has been revoked may re-apply for a waiver at such time as it again meets the appropriate materials and monitoring criteria of subsections 10.7.6.1 and 10.7.6.2.

10.7.6.5.1 A system with a full waiver or a lead waiver no longer satisfies the materials criteria of subsection 10.7.6.1.1 or has a 90th percentile level greater than 0.005 mg/L.

10.7.6.5.2 A system with a full waiver or a copper waiver no longer satisfies the materials criteria of subsection 10.7.6.1.2 or has a 90th percentile copper level greater than 0.65 mg/L.

10.7.6.5.3 The Division notifies the system, in writing, that the waiver has been revoked, setting forth the basis of its decision.

10.7.6.6 Requirements Following Waiver Revocation: A system whose full or partial waiver has been revoked by the Division is subject to the corrosion control treatment and lead and copper tap water monitoring requirements, as follows:

10.7.6.6.1 If the system exceeds the lead and/or copper action level, the system must implement corrosion control treatment in accordance with the deadlines specified in subsection 10.2.5, and any other applicable requirements of this subsection.

10.7.6.6.2 If the system meets both the lead and copper action level, the system must monitor for lead and copper at the tap no less frequently than once every three years using the reduced number of sample sites specified in subsection 10.7.3.

10.7.6.7 Pre-existing Waivers: Small system waivers approved by the Division in writing prior to April 11, 2000 shall remain in effect under the following conditions:

10.7.6.7.1 If the system has demonstrated that it is both free of lead-containing and copper-containing materials, as required by subsection 10.7.6.1 and that its 90th percentile lead levels and 90th percentile copper levels meet the criteria of subsection 10.7.6.2, the waiver remains in effect so long as the system continues to meet the waiver eligibility criteria of subsection 10.7.6.5. The first round of tap monitoring conducted pursuant to subsection 10.7.6.4 shall be completed no later than nine years after the last time the system has monitored for lead and copper at the tap.

10.7.6.7.2 If the system has met the materials criteria of subsection 10.7.6.1 but has not met the monitoring criteria of subsection 10.7.6.2, the system shall conduct a round of monitoring for lead and copper at the tap demonstrating that it meets the criteria of subsection 10.7.6.2, no later than September 30, 2003. Thereafter, the waiver shall remain in effect as long as the system meets the continued eligibility criteria of subsection 10.7.6.5. The first round of tap water monitoring conducted pursuant to subsection 10.7.6.4 shall be completed no later than nine years after the round of monitoring conducted pursuant to subsection 10.7.6.2.

10.8 Monitoring Requirements for Water Quality Parameters: All large water systems and all small and medium-size systems that exceed the lead or copper action level shall monitor water quality parameters in addition to lead and copper in accordance with this subsection. The requirements of this section are summarized in the table at the end of this section.

10.8.1 General Requirements:

10.8.1.1 Sample Collection Methods:

10.8.1.1.1 Tap samples shall be representative of water quality throughout the distribution system taking into account the number of persons served, the different sources of water, the different treatment methods employed by the system, and seasonal variability. Tap sampling under this section is not required to be conducted at taps targeted for lead and copper sampling under subsection 10.7.1. (NOTE: Systems may find it convenient to conduct tap sampling for water quality parameters at sites used for coliform sampling under Section 5.0.)

10.8.1.1.2 Samples collected at the entry point(s) to the distribution system shall be from locations representative of each source after treatment. If a system draws water from more than one source and the sources are combined before distribution, the system must sample at an entry point to the distribution system during periods of normal operating conditions (i.e., when water is representative of all sources being used).

10.8.1.2 Number of Samples:

10.8.1.2.1 Systems shall collect two tap samples for applicable water quality parameters during each monitoring period specified under subsections 10.8.2 and 10.8.5 from the following number of sites:

10.8.1.2.2 Except as provided in subsection 10.8.3.3, systems shall collect two samples for each applicable water quality parameter at each entry point to the distribution system during each monitoring period specified in subsection 10.8.2. During each monitoring period specified in subsections 10.8.3 through 10.8.5, systems shall collect one sample for each applicable water quality parameter at each entry point to the distribution system.

10.8.2 Initial Sampling: All large water systems shall measure the applicable water quality parameters as specified below at taps and at each entry point to the distribution system during each six-month monitoring period specified in subsection 10.7.4.1. All small and medium-size systems shall measure the applicable water quality parameters at the locations specified below during each six-month monitoring period specified in subsection 10.7.4.1 during which the system exceeds the lead or copper action levels.

10.8.2.1 At taps:

pH;

Alkalinity;

Orthophosphate, when an inhibitor containing a phosphate compound is used;

Silica, when an inhibitor containing a silicate compound is used;

Calcium;

Conductivity; and

Water Temperature.

10.8.2.2 At each entry point to the distribution system, all of the applicable parameters listed in subsection 10.8.2.1.

10.8.3 Monitoring after Installation of Corrosion Control: Any large system which installs optimal corrosion control treatment pursuant to subsection 10.2.4 Step 4 shall measure the water quality parameters at the locations and frequencies specified below during each six-month monitoring period specified in subsection 10.7.4.2.1. Any small or medium-size system which installs optimal corrosion control treatment shall conduct such monitoring during each six-month monitoring period specified in subsection 10.7.4.2.2 in which the system exceeds the lead or copper action level.

10.8.3.1 At taps two samples for:

pH;

Alkalinity;

Orthophosphate, when an inhibitor containing a phosphate compound is used;

Silica, when an inhibitor containing a silicate compound is used;

Calcium, when calcium carbonate stabilization is used as part of corrosion control.

10.8.3.2 Except as provided in subsection 10.8.3.3 at each entry point to the distribution system, one sample every two weeks (bi-weekly) for:

pH;

When alkalinity is adjusted as part of optimal corrosion control, a reading of the dosage rate of the chemical used to adjust alkalinity, and the alkalinity concentration; and

When a corrosion inhibitor is used as part of optimal corrosion control, a reading of the dosage rate of the inhibitor used, and the concentration of orthophosphate or silica (whichever is applicable).

10.8.3.3 Any groundwater system can limit entry point sampling described in subsection 10.8.3.2 to those entry points that are representative of water quality and treatment conditions throughout the system. If water from untreated groundwater sources mixes with water from treated groundwater sources, the system must monitor for water quality parameters both at representative entry points receiving treatment and representative points receiving no treatment. Prior to the start of any monitoring under this paragraph, the system shall provide to the Division written information identifying the selected entry points and documentation, including information on seasonal variability, sufficient to demonstrate that the sites are representative of water quality and treatment conditions throughout the system.

10.8.4 Monitoring after Division Specifies Water Quality Parameter Values for Optimal Corrosion Control: After the Division specifies the values for applicable water quality control parameters reflecting optimal corrosion control treatment under subsection 10.3.6, all large systems shall measure the applicable water quality parameters in accordance with subsection 10.8.3 and determine compliance with the requirements of subsection 10.3.7 every six months with the first six-month period to begin on either January 1 or July 1, whichever comes first, after the Division specifies the optimal values under subsection 10.3.6. Any small or medium-size system shall conduct such monitoring during each six-month period specified in this paragraph in which the system exceeds the lead or copper action level. For any such small and medium-size system that is subject to a reduced monitoring frequency pursuant to subsection 10.7.4.4 at the time of the action level exceedance, the start of the applicable six-month period under this paragraph shall coincide with the start of the applicable monitoring period under subsection 10.7.4.4. Compliance with the Division-designated optimal water quality parameter values shall be determined as specified under subsection 10.3.7.

10.8.5 Reduced Monitoring:

10.8.5.1 Any water system that maintains the range of values for the water quality parameters reflecting optimal corrosion control treatment during each of two consecutive six-month monitoring periods under subsection 10.8.4 shall continue monitoring at the entry point(s) to the distribution system as specified in subsection 10.8.3.2. Such system may collect two tap samples for applicable water quality parameters from the following reduced number of sites during each six-month monitoring period.

10.8.5.2 Frequency of monitoring

10.8.5.2.1 Any water system that maintains the range of values for the water quality parameters reflecting optimal corrosion control treatment specified by the Division under subsection 10.3.6 during three consecutive years of monitoring may reduce the frequency with which it collects the number of tap samples for applicable water quality parameters specified in subsection 10.8.5.1 from every six months to annually. This sampling begins during the calendar year immediately following the end of the monitoring period in which the third consecutive year of six-month monitoring occurs. Any water system that maintains the range of values for the water quality parameters reflecting optimal corrosion control treatment specified by the Division under subsection 10.3.6, during three consecutive years of annual monitoring under this paragraph may reduce the frequency with which it collects the number of tap samples for applicable water quality parameters specified in subsection 10.8.5.1 from annually to every three years. This sampling begins no later than the third calendar year following the end of the monitoring period in which the third consecutive year of monitoring occurs.

10.8.5.2.2 A water system may reduce the frequency with which it collects tap samples for applicable water quality parameters specified in subsection 10.8.5.1 to every three years if it demonstrates during two consecutive monitoring periods that its tap water lead level at the 90th percentile is less than or equal to the PQL (Practical Quantitation Level) for lead specified in subsection 10.12, that its tap water copper level at the 90th percentile is less than or equal to 0.65 mg/L for copper in subsection 10.1.3.2, and that it also has maintained the range of values for the water quality parameters reflecting optimal corrosion control treatment specified by the Division under subsection 10.3.6. Monitoring conducted every three years shall be done no later than every third calendar year.

10.8.5.3 A water system that conducts sampling annually shall collect these samples evenly throughout the year so as to reflect seasonal variability.

10.8.5.4 Any water system subject to reduced monitoring frequency that fails to operate within the range of values for the water quality parameters specified by the Division under subsection 10.3.6 for more than nine days in any six-month period specified in subsection 10.3.7 shall resume distribution system tap water sampling in accordance with the number and frequency requirements in subsection 10.8.4. Such a system may resume annual monitoring for water quality parameters at the tap at the reduced number of sites specified in subsection 10.8.5.1 after it has completed two subsequent consecutive six-month rounds of monitoring that meet the criteria of that section and/or may resume triennial monitoring for water quality parameters at the tap at the reduced number of sites after it demonstrates through subsequent rounds of monitoring that it meets the criteria of either subsections 10.8.5.2.1 or 10.8.5.2.2.

10.8.6 Additional Monitoring by Systems: The results of any monitoring conducted in addition to the minimum requirements of this section shall be considered by the system and the Division in making any determinations (i.e., determining concentrations of water quality parameters) under this section or subsection 10.3.

Summary of monitoring requirements for water quality parameters1

10.9 Monitoring Requirements for Lead and Copper in Source Water:

10.9.1 Sample Location Collection Methods, and Number of samples:

10.9.1.1 A water system that fails to meet the lead or copper action level on the basis of tap samples collected in accordance with subsection 10.7 shall collect lead and copper source water samples in accordance with the requirements regarding sample location, number of samples, and collection methods:

10.9.1.1.1 Groundwater systems shall take a minimum of one sample at every entry point to the distribution system which is representative of each well after treatment (hereafter called a sampling point). The system shall take one sample at the same sampling point unless conditions make another sampling point more representative of each source or treatment plant.

10.9.1.1.2 Surface water systems shall take a minimum of one sample at every entry point to the distribution system after any application of treatment or in the distribution system at a point which is representative of each source after treatment (hereafter called a sampling point). The system shall take each sample at the same sampling point unless conditions make another sampling point more representative of each source or treatment plant. NOTE: For the purpose of this paragraph, surface water systems include systems with a combination of surface and groundwater sources.

10.9.1.1.3 If a system draws water from more than one source and the sources are combined before distribution, the system must sample at an entry point to the distribution system during periods of normal operating conditions (i.e., when water is representative of all sources being used).

10.9.1.1.4 The Division may reduce the total number of samples which must be analyzed by allowing the use of compositing. Compositing of samples must be done by certified laboratory personnel. Composite samples from a maximum of five samples are allowed, provided that if the lead concentration in the composite sample is greater than or equal to 0.001 mg/L or the copper concentration is greater than or equal to 0.160 mg/L, then either:

10.9.1.1.4.1 A follow-up sample shall be taken and analyzed within 14 days at each sampling point included in the composite; or

10.9.1.1.4.2 If duplicates of or sufficient quantities from the original samples from each sampling point used in the composite are available, the system may use these instead of resampling.

10.9.1.2 Where the results of sampling indicate an exceedance of maximum permissible source water levels established under subsection 10.4.2.4, the Division may require that one additional sample be collected as soon as possible after the initial sample was taken (but not to exceed two weeks) at the same sampling point. If a Division-required confirmation sample is taken for lead or copper, then the results of the initial and confirmation sample shall be averaged in determining compliance with the Division-specified maximum permissible levels. Any sample value below the detection limit shall be considered to be zero. Any value above the detection limit but below the PQL shall either be considered as the measure value or be considered one-half the PQL.

10.9.2 Monitoring Frequency after System Exceeds Tap Water Action Level: Any system which exceeds the lead or copper action level at the tap shall collect one source water sample from each entry point to the distribution system within six months after the end of the monitoring period during which the lead or copper action level was exceeded. For monitoring periods that are annual or less frequent, the end of the monitoring period is September 30 of the calendar year in which the sampling occurs, or if the Division has established an alternate monitoring period, the last day of that period.

10.9.3 Monitoring Frequency after Installation of Source Water Treatment: Any system which installs source water treatment pursuant to subsection 10.4.1 Step 3 shall collect an additional source water sample from each entry point to the distribution system during two consecutive six-month monitoring periods by the deadline specified in subsection 10.4.1 Step 4.

10.9.4 Monitoring Frequency after Division Specifies Maximum Permissible Source Water Levels or Determines that Source Water Treatment is not Needed:

10.9.4.1 A system shall monitor at the frequency specified below in cases where the Division specifies maximum permissible source water levels under subsection 10.4.2.4 or determines that the system is not required to install source water treatment under subsection 10.4.2.2.

10.9.4.1.1 A water system using only groundwater shall collect samples once during the three-year compliance period (as that term is defined in section 1.0) in effect when the applicable Division determination under section 10.9.4.1 is made. Such systems shall collect samples once during each subsequent compliance period. Triennial samples shall be collected every third calendar year.

10.9.4.1.2 A water system using surface water (or a combination of surface and groundwater) shall collect samples once during each calendar year, the first annual monitoring period to begin during the year in which the applicable Division determination is made under subsection 10.9.4.1.

10.9.4.2 A system is not required to conduct source water sampling for lead and/or copper if the system meets the action level for the specific contaminant in tap water samples during the entire source water sampling period applicable to the system under subsection 10.9.4.1.1 or 10.9.4.1.2.

10.9.5 Reduced Monitoring Frequency:

10.9.5.1 A water system using only groundwater may reduce the monitoring frequency for lead and copper in source water to once during each nine-year compliance cycle (as that term is defined in section 1.0) provided that the samples are collected no later than every ninth calendar year and if the system meets one of the following criteria:

10.9.5.1.1 The system demonstrates that finished drinking water entering the distribution system has been maintained below the maximum permissible lead and copper concentrations specified by the Division in subsection 10.4.2.4 during at least three consecutive compliance periods under subsection 10.9.4.1; or

10.9.5.1.2 The Division has determined that source water treatment is not needed and the system demonstrates that, during at least three consecutive compliance periods in which sampling was conducted under subsection 10.9.4.1, the concentration of lead in source water was less than or equal to 0.005 mg/L and the concentration of copper in source water was less than or equal to 0.65 mg/L.

10.9.5.2 A water system using surface water (or a combination of surface and ground water) may reduce the monitoring frequency in subsection 10.9.4.1 to once during each nine-year compliance cycle (as that term is defined in section 1.0) provided that the samples are collected no later than every ninth calendar year and if the system meets one of the following criteria:

10.9.5.2.1 The system demonstrates that finished drinking water entering the distribution system has been maintained below the maximum permissible lead and copper concentrations specified by the Division in subsection 10.4.2.4 during at least three consecutive years; or

10.9.5.2.2 The Division has determined that source water treatment is not needed and the system demonstrates that, during at least three consecutive years, the concentration of lead in source water was less than or equal to 0.005 mg/L and the concentration of copper in source water was less than or equal to 0.65 mg/L.

10.9.5.3 A water system that uses a new source of water is not eligible for reduced monitoring for lead and/or copper until concentrations in samples collected from the new source during three consecutive monitoring periods are below the maximum permissible lead and copper concentrations specified by the Division in subsection 10.4.1 Step 5.

10.10 Reporting Requirements: All water systems shall report all of the following information to the Division in accordance with this section.

10.10.1 Reporting Requirements for Tap Water Monitoring for Lead and Copper and for Water Quality Parameter Monitoring:

10.10.1.1 Except as provided in subsection 10.10.1.1.8, a water system shall report the information specified below for all tap water samples specified in 10.7 and for all water quality parameter samples specified in subsection 10.8 within the first 10 days following the end of each applicable monitoring period specified in subsections 10.7, and 10.8, (i.e., every six-months, annually, every 3 years or every 9 years). For monitoring periods with a duration less than six months, the end of the monitoring period is the last date samples can be collected during the period specified in subsections 10.7 and 10.8.

10.10.1.1.1 The results of all tap samples for lead and copper including the location of each site and the criteria under subsections 10.7.1.3, 10.7.1.4, 10.7.1.5, 10.7.1.6 or 10.7.1.7 under which the site was selected for the system’s sampling pool;

10.10.1.1.2 Documentation for each tap water lead or copper sample for which the water system requests invalidation pursuant to subsection 10.7.6.2;

10.10.1.1.3 Reserved

10.10.1.1.4 The 90th percentile lead and copper concentrations measured from among all lead and copper tap water samples collected during each monitoring period (calculated in accordance with subsection 10.1.1.3) unless the Division calculates the 90th percentile lead and copper levels under subsection 10.10.8;

10.10.1.1.5 With the exception of initial tap sampling conducted pursuant to subsection 10.7.4.1 the system shall designate any site which was not sampled during previous monitoring periods, and include an explanation of why sampling sites have changed;

10.10.1.1.6 The results of all tap samples for pH, and where applicable, alkalinity, calcium, conductivity, temperature, and orthophosphate or silica collected under subsections 10.8.2 through 10.8.5.

10.10.1.1.7 The results of all samples collected at the entry point(s) to the distribution system for applicable water quality parameters under subsections 10.8.2 through 10.8.5.

10.10.1.1.8 A water system shall report the results of all water quality parameter samples collected under subsections 10.8.3 through 10.8.6 during each six-month monitoring period specified in subsection 10.8.4 within the first ten days following the end of the monitoring period unless the Division has specified a more frequent reporting requirement.

10.10.1.2 For a non-transient non-community water system, or a community water system meeting the criteria of subsection 10.6.2.7, that does not have enough taps that can provide first-draw samples, the system must either:

10.10.1.2.1 Provide written documentation to the Division identifying standing times and locations for enough non-first-draw samples to make up its sampling pool under subsection 10.7.2.5 by the start of the first applicable monitoring period under subsection 10.7.4 that commences after April 11, 2000, unless the Division has waived prior Division approval of non-first-draw sample sites selected by the system pursuant to subsection 10.7.2.5; or

10.10.1.2.2 If the Division has waived prior approval of non-first-draw sample sites selected by the system, identify, in writing, each site that did not meet the six-hour minimum standing time and the length of standing time for that particular substitute sample collected pursuant to subsection 10.7.2.5 and include this information with the lead and copper tap sample results required to be submitted pursuant to subsection 10.10.1.1.1.

10.10.1.3 At a time specified by the Division, or if no specific time is designated by the Division, then as early as possible prior to the addition of a new source or any long-term change in water treatment, a water system deemed to have optimized corrosion control under subsection 10.2.2.3, a water system subject to reduced monitoring pursuant to subsection 10.7.4.4, or a water system subject to a monitoring waiver pursuant to subsection 10.7.7, shall submit written documentation to the Division describing the change or addition. The Division must review and approve the addition of the new source or long-term change in treatment before it is implemented by the water system. Examples of long-term treatment changes include the addition of a new treatment process or modification of an existing treatment process. Examples of modifications include switching secondary disinfectants, switching coagulants (e.g., orthophosphate to blended phosphate), switching corrosion inhibitor products (e.g., alum to ferric chloride). Long-term changes can include dose changes to existing chemicals if the system is planning long-term changes to its finished pH or residual inhibitor concentration. Long-term treatment changes would not include chemical dose fluctuations associated with daily raw water quality changes.

10.10.1.4 Any small system applying for a monitoring waiver under subsection 10.7.6, or subject to a waiver granted pursuant to subsection 10.7.6.3, shall provide the following information to the Division in writing by the specified deadline:

10.10.1.4.1 By the start of the first applicable monitoring period in subsection 10.7.4, any small water system applying for a monitoring waiver shall provide the documentation required to demonstrate that it meets the waiver criteria of subsections 10.7.6.1 and 10.7.6.2.

10.10.1.4.2 No later than nine years after the monitoring previously conducted pursuant to subsection 10.7.6.2 or subsection 10.7.6.4.1, each small system desiring to maintain its monitoring waiver shall provide the information required by subsections 10.7.6.4.1 and 10.7.6.4.2.

10.10.1.4.3 No later than 60 days after it becomes aware that it is no longer free of lead-containing and/or copper-containing material, as appropriate, each small system with a monitoring waiver shall provide written notification to the Division, setting forth the circumstances resulting in the lead-containing and/or copper-containing materials being introduced into the system and what corrective action, if any, the system plans to remove these materials.

10.10.1.4.4 By October 10, 2003, any small system with a waiver granted prior to April 11, 2000 and that has not previously met the requirements of subsection 10.7.6.2 shall provide the information required by that section.

10.10.1.5 Each groundwater system that limits water quality parameter monitoring to a subset of entry points under subsection 10.8.3.3 shall provide, by the commencement of such monitoring, written correspondence to the Division that identifies the selected entry points and includes the information sufficient to demonstrate that the sites are representative of water quality and treatment conditions throughout the system.

10.10.2 Source Water Monitoring Reporting Requirements:

10.10.2.1 A water system shall report the sampling results for all source water samples collected in accordance with subsection 10.9 within the first 10 days following the end of each source water monitoring period (i.e., annually, per compliance period, per compliance cycle) specified in subsection 10.9.

10.10.2.2 With the exception of the first round of source water sampling conducted pursuant to subsection 10.9.2, the system shall specify any site which was not sampled during previous monitoring periods, and include an explanation of why the sampling point has changed.

10.10.3 Corrosion Control Treatment Reporting Requirements: By the applicable dates under subsection 10.2, systems shall report the following information:

10.10.3.1 For systems demonstrating that they have already optimized corrosion control, information required in subsections 10.2.2.2 or 10.2.2.3;

10.10.3.2 For systems required to optimize corrosion control, their recommendation regarding optimal corrosion control treatment under subsections 10.3.1;

10.10.3.3 For systems required to evaluate the effectiveness of corrosion control treatments under subsection 10.3.3, the information required by that paragraph; and

10.10.3.4 For systems required to install optimal corrosion control designated by the Division under subsection 10.3.4, a letter certifying that the system has completed installing that treatment.

10.10.4 Source Water Treatment Reporting Requirements: By the applicable dates in subsections 10.4, systems shall provide the following information to the Division:

10.10.4.1 If required under subsection 10.4.2.1 their recommendation regarding source water treatment; and

10.10.4.2 For systems required to install source water treatment under subsection 10.4.2.2, a letter certifying that the system has completed installing the treatment designated by the Division within 24 months after the Division designated the treatment.

10.10.5 Lead Service Line Replacement Reporting Requirements: Systems shall report the following information to the Division to demonstrate compliance with the requirements of subsection 10.5:

10.10.5.1 No later than 12 months after the end of the monitoring period in which a system exceeds the lead action level in sampling referred to in subsection 10.5.1, the system must submit written documentation to the Division of the material evaluation conducted as required in subsection 10.7.1, identify the initial number of lead service lines in its distribution system at the time the system exceeds the lead action level, and provide the system’s schedule for annually replacing at least 7 percent of the initial number of lead service lines in its distribution system.

10.10.5.2 No later than 12 months after the end of the monitoring period in which a system exceeds the lead action level in sampling referred to in subsection 10.5.1, and every 12 months thereafter, the system shall demonstrate to the Division in writing that the system has either:

10.10.5.2.1 Replaced in the previous 12 months at least 7 percent of the initial lead service lines (or a greater number of lines specified by the Division under subsection 10.5.5 in its distribution system; or

10.10.5.2.2 Conducted sampling which demonstrates that the lead concentration in all service lines samples from an individual line(s), taken pursuant to subsection 10.7.2.3, is less than or equal to 0.015 mg/L. In such cases, the total number of lines replaced and/or which meet the criteria in subsection 10.5.3 shall equal at least 7 percent of the initial number of lead lines identified under subsection 10.10.5.1 (or the percentage specified by the Division under subsection 10.5.5.

10.10.5.3 The annual letter submitted to the Division under subsection 10.10.5.2 shall contain the following information:

10.10.5.3.1 The number of lead service lines scheduled to be replaced during the previous year of the system’s replacement schedule;

10.10.5.3.2 The number and location of each lead service line replaced during the previous year of the system’s replacement schedule; and

10.10.5.3.3 If measured, the water lead concentration and location of each lead service line sampled, the sampling method, and the date of sampling.

10.10.5.4 Any system which collects lead service line samples following partial lead service line replacement required by subsection 10.5 shall report the results to the Division within the first ten days of the month following the month in which the system receives the laboratory results, or as specified by the Division. The Division, at its discretion may eliminate this requirement to report these monitoring results. Systems shall also report any additional information as specified by the Division, and in a time and manner prescribed by the Division, to verify that all partial lead service line replacement activities have taken place.

10.10.6 Public Education Program Reporting Requirements:

10.10.6.1 Any water system that is subject to the public education requirements in subsection 10.6 shall, within ten days after the end of each period in which the system is required to perform public education tasks in accordance with subsection 10.6.2, send written documentation to the Division that contains:

10.10.6.1.1 A demonstration that the system has delivered the public education materials that meet the content requirements in subsection 10.6.1 and the delivery requirements in subsection 10.6.2; and

10.10.6.1.2 A list of all newspapers, radio stations, television stations, and facilities and organizations to which the system delivered public education materials during the period in which the system was required to perform public education tasks.

10.10.6.2 Unless required by the Division, a system that previously has submitted the information required in subsection 10.10.6.1.2 need not resubmit the information required by subsection 10.10.6.1.2, as long as there have been no changes in the distribution list and the system certifies that the public education materials were distributed to the same list submitted previously.

10.10.6.3 No later than 3 months following the end of the monitoring period, each system must mail a sample copy of the consumer notification of tap results to the Division along with a certification that the notification has been distributed in a manner consistent with the requirements of subsection 10.6.4.

10.10.7 Reporting of Additional Monitoring Data: Any system which collects sampling data in addition to that required by this section shall report the results to the Division within the first ten days following the end of the applicable monitoring period under subsections 10.7, 10.8 and 10.9 during which the samples are collected.

10.10.8 Reporting of the 90th percentile lead and copper concentrations where the Division calculates a system’s 90th percentile concentrations. A water system is not required to report the 90th percentile lead and copper concentrations measured from among all lead and copper tap water samples collected during each monitoring period, as required by subsection 10.10.1.1.4 if:

10.10.8.1 The Division has previously notified the water system that it will calculate the water system’s 90th percentile lead and copper concentrations, based on the lead and copper tap results submitted pursuant to subsection 10.10.8.2.1, and has specified a date before the end of the applicable monitoring period by which the system must provide the results of lead and copper tap water samples;

10.10.8.2 The system has provided the following information to the Division by the date specified in subsection 10.10.8.1:

10.10.8.2.1 The results of all tap samples for lead and copper including the location of each site and the criteria under subsections 10.7.1.3, 10.7.1.4, 10.7.1.5, 10.7.1.6 and/or 10.7.1.7 under which the site was selected for the system’s sampling pool, pursuant to subsection 10.10.1.1.1; and

10.10.8.2.2 An identification of sampling sites utilized during the current monitoring period that were not sampled during previous monitoring periods, and an explanation why sampling sites have changed; and

10.10.8.3 The Division has provided the results of the 90th percentile lead and copper calculations, in writing, to the water system before the end of the monitoring period.

10.11 Recordkeeping Requirements: Any system subject to the requirements of this section shall retain on its premises original records of all sampling data and analyses, reports, surveys, letters, evaluations, schedules, Division determinations, and any other information required by subsections 10.2 through 10.9. Each water system shall retain the records required by this section for no fewer than 12 years.

10.12 Analytical Methodology: Analysis for compliance with this section shall be conducted in accordance with 40 CFR 141.89. Copies may be obtained from the Office of Drinking Water.

**History**
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *25 DE Reg. 713 (01/01/22)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *5 DE Reg. 2121 (05/01/02)*
- *9 DE Reg. 999 (12/01/05)*
- *15 DE Reg. 73 (07/01/12)*
- *17 DE Reg. 439 (10/01/13)*
- *19 DE Reg. 517 (12/01/15)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *25 DE Reg. 713 (01/01/22)*

##### **16 Del. Admin. Code § 4462-11.0** Corrosivity {#sec-4462-11.0 omnilex-key=us-de-regs-official--title-16--4462-11.0}

11.1 Corrosivity Sampling, Reporting and Analytical Methodology: Suppliers of water for community public water systems shall collect samples from a representative entry point to the water distribution system for the purpose of analyses to determine the corrosivity characteristics of the water.

11.1.1 Sampling Requirements: For water suppliers utilizing surface water wholly or in part, two (2) samples per plant are required, one (1) during mid-winter and one (1) during mid-summer. For water suppliers utilizing wholly ground water sources, one (1) sample per plant per year shall be required.

11.1.1.1 The minimum number of samples required to be taken by the system shall be based on the number of treatment plants used by the system, except that multiple wells drawing raw water from a single aquifer may be considered one (1) treatment plant for determining the minimum number of samples.

11.1.1.2 Determination of the corrosivity characteristics of the water shall include measurement of pH, calcium hardness, alkalinity, temperature, total dissolved solids (total filterable residue) and the calculation of the Langelier Index (LI) in accordance with subsection 11.1.3.1. The determination of corrosivity characteristics shall only include one (1) round of sampling (two (2) samples per plant for surface water and one sample per plant for ground water sources). However, the Division may require addition or more frequent monitoring as appropriate. In addition, the Division has the discretion to require monitoring for additional parameters which may indicate corrosivity characteristics such as sulfates and chlorides. In certain cases, the Aggressive Index (AI) as described in subsection 11.1.3.2 can be used instead of the LI. The Division will make this determination. Waters exhibiting a LI of less than -2.0 or an AI of less than 10.0 shall be considered highly corrosive/aggressive.

11.1.2 Reporting to the Division: The supplier of water shall report to the Division the results of the analyses for corrosivity characteristics pursuant to subsection 4.1.1.

11.1.3 Analytical Methodology: Analyses conducted to determine the corrosivity of the water shall be made in accordance with the following methods:

11.1.3.1 Langelier Index -- "Standard Methods for the Examination of Water and Wastewater," 19th Edition, Method 203.

11.1.3.2 Aggressive Index -- "AWWA Standard for Asbestos-Cement Pipe, 4 in. through 24 in. for Water Other Liquids," AWWA C400-77, Revision of C400-75, AWWA, Denver, Colorado.

11.1.3.3 Total Filterable Residue -- "Standard Methods for the Examination of Water and Wastewater," 19th Edition, Method 208B, or "Methods of Chemical Analysis of Water and Wastes," Method 160.1.

11.1.3.4 Temperature, Calcium, Alkalinity, and pH -- in accordance with 40 CFR 141.23(k)(1). Copies may be obtained from the Office of Drinking Water.

11.1.3.5 Chloride and Sulfate – in accordance with 40 CFR 143.4. Copies may be obtained from the Office of Drinking Water.

11.1.3.6 Any alternate analytical technique approved by the Division.

11.1.4 Reporting of Construction Materials: PWSs shall identify whether the following construction materials are present in their distribution system and report to the Division:

11.1.4.1 Lead from piping, solder, caulking, interior lining of distribution mains, alloys and home plumbing.

11.1.4.2 Copper from piping and alloys, service lines and home plumbing.

11.1.4.3 Galvanized piping, service lines and home plumbing.

11.1.4.4 Ferrous piping materials such as cast iron and steel.

11.1.4.5 Asbestos cement pipe.

11.1.4.6 Vinyl lined asbestos cement pipe.

11.1.4.7 Coal tar lined pipes and tanks.

11.1.4.8 In addition, the Division may require identification and reporting of other materials of construction present in distribution systems that may contribute contaminants to the drinking water.

**History**
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *25 DE Reg. 713 (01/01/22)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *5 DE Reg. 2121 (05/01/02)*
- *9 DE Reg. 999 (12/01/05)*
- *15 DE Reg. 73 (07/01/12)*
- *17 DE Reg. 439 (10/01/13)*
- *19 DE Reg. 517 (12/01/15)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *25 DE Reg. 713 (01/01/22)*

##### **16 Del. Admin. Code § 4462-12.0** Disinfectant Residuals, Disinfection Byproducts, and Disinfection Precursors {#sec-4462-12.0 omnilex-key=us-de-regs-official--title-16--4462-12.0}

12.1 General requirements: The requirements of this section constitute national primary drinking water regulations.

12.1.1 The regulations in this section establish criteria under which community water systems (CWSs) and non-transient, non-community water systems (NTNCWSs) which add a chemical disinfectant to the water in any part of the drinking water treatment process must modify their practices to meet MCLs and MRDLs in subsections 9.2.1.2 and 1.19.3 respectively, and must meet the treatment technique requirements for disinfection byproduct precursors in subsection 12.9.

12.1.2 The regulations in this section establish criteria under which transient NCWSs that use chlorine dioxide as a disinfectant or oxidant must modify their practices to meet the MRDL for chlorine dioxide in subsection 1.19.3.

12.1.3 EPA has established MCLs for TTHM and HAA5 and treatment technique requirements for disinfection byproduct precursors to limit the levels of known and unknown disinfection byproducts which may have adverse health effects. These disinfection byproducts may include chloroform; bromodichloromethane; dibromochloromethane; bromoform; dichloroacetic acid; and trichloroacetic acid.

12.2 Compliance Dates

12.2.1 CWSs and NTNCWSs. Unless otherwise noted, systems must comply with the requirements of this section as follows. Surface water or ground water under the direct influence of surface water systems serving 10,000 or more persons must comply with this section beginning December 16, 2001. Surface water or ground water under the direct influence of surface water systems serving fewer than 10,000 persons and systems using only ground water not under the direct influence of surface water must comply with this section beginning December 16, 2003. All systems must comply with these MCLs until the date specified in subsection 14.1.3.

12.2.2 Transient NCWSs. Surface water or ground water under the direct influence of surface water systems serving 10,000 or more persons and using chlorine dioxide as a disinfectant or oxidant must comply with any requirements for chlorine dioxide and chlorite in this section beginning December 16, 2001. Surface water or ground water under the direct influence of surface water systems serving fewer than 10,000 persons and using chlorine dioxide as a disinfectant or oxidant and systems using only ground water not under the direct influence of surface water and using chlorine dioxide as a disinfectant or oxidant must comply with any requirements for chlorine dioxide and chlorite in this section beginning December 16, 2003.

12.3 Each CWS and NTNCWS regulated under subsection 12.1 must be operated by qualified personnel who meet the requirements specified by the Division and are included in a State register of qualified operators.

12.4 Control of disinfectant residuals. Notwithstanding the MRDLs in subsection 1.19.3, systems may increase residual disinfectant levels in the distribution system of chlorine or chloramines (but not chlorine dioxide) to a level and for a time necessary to protect public health, to address specific microbiological contamination problems caused by circumstances such as, but not limited to, distribution line breaks, storm run-off events, source water contamination events, or cross-connection events.

12.5 For compliance with this section systems must use analytical methods in accordance with 40 CFR 141.131(a); 40 CFR 141.131(b)(1-2); 40 CFR 141.131(c)(1-2); and 40 CFR 141.131(d)(1-6. Copies may be obtained from the Office of Drinking Water.

12.5.1 Analysis under this section for disinfection byproducts must be conducted by laboratories that have received certification by EPA or the Division, except as specified under subsection 12.7.2.1.3. To receive certification to conduct analysis for the contaminants in subsection 9.2.1.2, the laboratory must carry out annual analyses of performance evaluation (PE) samples approved by EPA or the Division. In the analyses of PE samples, the laboratory must achieve quantitative results within the acceptance limit as specified in 40 CFR 141.131(b)(2).

12.5.2 A party approved by the EPA or the Division must measure residual disinfectant concentration.

12.6 Monitoring requirements – General requirements:

12.6.1 Systems must take all samples during normal operating conditions.

12.6.2 Systems may consider multiple wells drawing from a single aquifer as one treatment plant for determining the minimum of TTHM and HAA5 samples required, with the approval of the Division.

12.6.3 Failure to monitor in accordance with the monitoring plan required under subsection 12.11 is a monitoring violation.

12.6.4 Failure to monitor will be treated as a violation for the entire period covered by the annual average where compliance is based on a running annual average of monthly or quarterly samples or averages and the system's failure to monitor makes it impossible to determine compliance with MCLs or MRDLs.

12.6.5 Systems may use only data collected under the provisions of this section or 61 FR 24368, May 14, 1996 to qualify for reduced monitoring.

12.7 Monitoring requirements for disinfection byproducts:

12.7.1 TTHM and HAA5

12.7.1.1 Routine monitoring. Systems must monitor at the frequency indicated in the following table:

12.7.1.2 Reduced monitoring. Systems may reduce monitoring, except as otherwise provided, in accordance with the following table:

Note: Any Surface water or ground water under the direct influence of surface water system serving fewer than 500 persons may not reduce its monitoring to less than one sample per treatment plant per year.

12.7.1.3 Monitoring requirements for source water TOC. In order to qualify for reduced monitoring for TTHM and HAA5 under subsection 12.7.1.2, surface water or ground water under the direct influence of surface water systems not monitoring under the provisions of subsection 12.9.1 must take monthly TOC samples every 30 days at a location prior to any treatment, beginning April 1, 2008 or earlier, if specified by the Division. In addition to meeting the other criteria for reduced monitoring in subsection 12.7.1.2, the source water TOC running annual average must be <4.0 mg/L (based on the most recent four quarters of monitoring) on a continuing basis at each treatment plant to reduce or remain on reduced monitoring for TTHM and HAA5. Once qualified for reduced monitoring for TTHM and HAA5 under subsection 12.7.1.2, a system may reduce source water TOC monitoring to quarterly TOC samples taken every 90 days at a location prior to treatment.

12.7.1.4 Systems on a reduced monitoring schedule may remain on that reduced schedule as long as the average of all samples taken in the year (for systems which must monitor quarterly) or the result of the sample (for systems which must monitor no more frequently than annually) is no more than 0.060 mg/L and 0.045 mg/L for TTHMs and HAA5, respectively. Systems that do not meet these levels must resume monitoring at the frequency identified in subsection 12.7.1.1 in the quarter immediately following the quarter in which the system exceeds 0.060 mg/L and 0.045 mg/L for TTHMs and HAA5, respectively. For systems using only groundwater not under the direct influence of surface water and serving fewer than 10,000 persons, if either the TTHM annual average is >0.080 mg/L or the HAA5 annual average is >0.060 mg/L, the system must go to increased monitoring identified in subsection 12.7.1.1 (sample location column) in the quarter immediately following the monitoring period in which the system exceeds 0.080 mg/L or 0.060 mg/L for TTHMs or HAA5s respectively.

12.7.1.5 Systems on increased monitoring may return to routine monitoring if, after at least one year of monitoring their TTHM annual average is <0.060 mg/L and their HAA5 annual average is <0.045 mg/L.

12.7.1.6 The Division may return a system to routine monitoring at the Division’s discretion.

12.7.2 Chlorite. Community and non-transient non-community water systems using chlorine dioxide, for disinfection or oxidation, must conduct monitoring for chlorite.

12.7.2.1 Routine monitoring

12.7.2.1.1 Daily monitoring. Systems must take daily samples at the entrance to the distribution system. For any daily sample that exceeds the chlorite MCL, the system must take additional samples in the distribution system the following day at the locations required by subsection 12.7.2.2, in addition to the sample required at the entrance to the distribution system.

12.7.2.1.2 Monthly monitoring. Systems must take a three-sample set each month in the distribution system. The system must take one sample at each of the following locations: near the first customer, at a location representative of average residence time, and at a location reflecting maximum residence time in the distribution system. Any additional routine sampling must be conducted in the same manner (as three-sample sets, at the specified locations). The system may use the results of additional monitoring conducted under subsection 12.7.2.2 to meet the requirement for monitoring in this paragraph.

12.7.2.1.3 A party approved by EPA or the Division must measure daily chlorite samples at the entrance to the distribution system.

12.7.2.2 Additional monitoring. On each day following a routine sample monitoring result that exceeds the chlorite MCL at the entrance to the distribution system, the system is required to take three chlorite distribution system samples at the following locations: as close to the first customer as possible, in a location representative of average residence time, and as close to the end of the distribution system as possible (reflecting maximum residence time in the distribution system).

12.7.2.3 Reduced monitoring.

12.7.2.3.1 Chlorite monitoring at the entrance to the distribution system required by subsection 12.7.2.1.1 may not be reduced.

12.7.2.3.2 Chlorite monitoring in the distribution system required by subsection 12.7.2.1.2 may be reduced to one three-sample set per quarter after one year of monitoring where no individual chlorite sample taken in the distribution system under subsection 12.7.2.1.2 has exceeded the chlorite MCL and the system has not been required to conduct monitoring under subsection 12.7.2.2. The system may remain on the reduced monitoring schedule until either any of the three individual chlorite samples taken quarterly in the distribution system under subsection 12.7.2.1.2 exceeds the chlorite MCL or the system is required to conduct monitoring under subsection 12.7.2.2, at which time the system must revert to routine monitoring.

12.7.3 Bromate.

12.7.3.1 Routine monitoring. Community and non-transient non-community systems using ozone, for disinfection or oxidation, must take one sample per month for each treatment plant in the system using ozone. Systems must take samples monthly at the entrance to the distribution system while the ozonation system is operating under normal conditions.

12.7.3.2 Reduced monitoring.

12.7.3.2.1 Until March 31, 2009, systems required to analyze for bromate may reduce monitoring from monthly to once per quarter, if the system demonstrates that the average source water bromide concentration is less than 0.05 mg/L based upon representative monthly bromide measurements for one year. The system may remain on reduced bromate monitoring until the running annual average source water bromide concentration, computed quarterly, is equal to or greater than 0.05 mg/L based upon representative monthly measurements. If the running annual average source water bromide concentration is ≥0.05 mg/L, the system must resume routine monitoring required by subsection 12.7.3.1.

12.7.3.2.2 Beginning April 1, 2009, systems may no longer use the provisions of subsection 12.7.3.2.1 to qualify for reduced monitoring. A system required to analyze for bromate may reduce monitoring from monthly to quarterly, if the system running annual average bromate concentration is ≤0.0025 mg/L based on monthly bromate measurements under subsection 12.7.3.1 for the most recent four quarters, with samples analyzed using Method 317.0 Revision 2.0, 326.0 or 321.8. If a system has qualified for reduced bromate monitoring under subsection 12.7.3.2.1 that system may remain on reduced monitoring as long as the running annual average of quarterly bromate samples ≤0.0025 mg/L based on samples analyzed using Method 317.0 Revision 2.0, 326.0, or 321.8. If the running annual average bromate concentration is >0.0025 mg/L, the system must resume routine monitoring required by subsection 12.7.3.1.

12.8 Monitoring requirements for disinfectant residuals.

12.8.1 Chlorine and Chloramines.

12.8.1.1 Routine monitoring. Systems must measure the residual disinfectant level at the same points in the distribution system and at the same time as total coliforms are sampled, as specified in Section 7.0.

12.8.1.2 Reduced monitoring. Monitoring may not be reduced.

12.8.2 Chlorine dioxide.

12.8.2.1 Routine monitoring. Community, non-transient non-community, and transient non-community water systems that use chlorine dioxide for disinfection or oxidation must take daily samples at the entrance to the distribution system. For any daily sample that exceeds the MRDL, the system must take samples in the distribution system the following day at the locations required by subsection 12.8.2.2, in addition to the sample required at the entrance to the distribution system.

12.8.2.2 Additional monitoring. On each day following a routine sample monitoring result that exceeds the MRDL, the system is required to take three chlorine dioxide distribution system samples. If chlorine dioxide or chloramines are used to maintain a disinfectant residual in the distribution system, or if chlorine is used to maintain a disinfectant residual in the distribution system and there are no disinfection addition points after the entrance to the distribution system (i.e., no booster chlorination), the system must take three samples as close to the first customer as possible, at intervals of at least six hours. If chlorine is used to maintain a disinfectant residual in the distribution system and there are one or more disinfection addition points after the entrance to the distribution system (i.e., booster chlorination), the system must take one sample at each of the following locations: as close to the first customer as possible, in a location representative of average residence time, and as close to the end of the distribution system as possible (reflecting maximum residence time in the distribution system).

12.8.2.3 Reduced monitoring. Chlorine dioxide monitoring may not be reduced.

12.9 Monitoring requirements for disinfection byproduct precursors (DBPP).

12.9.1 Routine monitoring. Surface water or ground water under the direct influence of surface water systems which use conventional filtration treatment (as defined in Section 1.0) must monitor each treatment plant for TOC no later than the point of combined filter effluent turbidity monitoring and representative of the treated water. All systems required to monitor under this paragraph must also monitor for TOC in the source water prior to any treatment at the same time as monitoring for TOC in the treated water. These samples (source water and treated water) are referred to as paired samples. At the same time as the source water sample is taken, all systems must monitor for alkalinity in the source water prior to any treatment. Systems must take one paired sample and one source water alkalinity sample per month per plant at a time representative of normal operating conditions and influent water quality.

12.9.2 Reduced monitoring. Surface water or ground water under the direct influence of surface water systems with an average treated water TOC of less than 2.0 mg/L for two consecutive years, or less than 1.0 mg/L for one year, may reduce monitoring for both TOC and alkalinity to one paired sample and one source water alkalinity sample per plant per quarter. The system must revert to routine monitoring in the month following the quarter when the annual average treated water TOC ≥2.0 mg/L.

12.10 Bromide: Until April 1, 2009, systems required to analyze for bromate may reduce bromate monitoring from monthly to once per quarter, if the system demonstrates that the average source water bromide concentration is less than 0.05 mg/L based upon representative monthly measurements for one year. The system must continue bromide monitoring to remain on reduced bromate monitoring.

12.11 Monitoring plans. Each system required to monitor under this Section 12.0 must develop and implement a monitoring plan. The system must maintain the plan and make it available for inspection by the Division and the general public no later than 30 days following the applicable compliance dates in subsection 12.2. All Surface water or ground water under the direct influence of surface water systems serving more than 3,300 people must submit a copy of the monitoring plan to the Division no later than the date of the first report required under subsection 12.6. The Division may also require the plan to be submitted by any other system. After review, the Division may require changes in any plan elements. The plan must include at least the following elements.

12.11.1 Specific locations and schedules for collecting samples for any parameters included in this section.

12.11.2 How the system will calculate compliance with MCLs, MRDLs, and treatment techniques.

12.11.3 If approved for monitoring as a consecutive system, or if providing water to a consecutive system, under the provisions of subsection 1.16.2, the sampling plan must reflect the entire distribution system.

12.12 Compliance requirements:

12.12.1 General requirements.

12.12.1.1 Where compliance is based on a running annual average of monthly or quarterly samples or averages and the system's failure to monitor for TTHM, HAA5, or bromate, this failure to monitor will be treated as a monitoring violation for the entire period covered by the annual average. Where compliance is based on a running annual average of monthly or quarterly samples or averages and the system's failure to monitor makes it impossible to determine compliance with MRDLs for chlorine and chloramines, this failure to monitor will be treated as a monitoring violation for the entire period covered by the annual average.

12.12.1.2 All samples taken and analyzed under the provisions of this section must be included in determining compliance, even if that number is greater than the minimum required.

12.13 Disinfection byproducts.

12.13.1 TTHMs and HAA5s

12.13.1.1 For systems monitoring quarterly, compliance with MCLs in subsection 9.2.1.2 must be based on a running annual arithmetic average, computed quarterly, of quarterly arithmetic averages of all samples collected by the system as prescribed by subsection 12.7.1. If the running annual arithmetic average of quarterly averages covering any consecutive four-quarter period exceeds the MCL, the system is in violation of the MCL and must notify the public pursuant to subsection 4.2, in addition to reporting to the Division pursuant to subsection 12.15. If a PWS fails to complete four consecutive quarters' monitoring, compliance with the MCL for the last four-quarter compliance period must be based on an average of the available data.

12.13.1.2 For systems monitoring less frequently than quarterly, compliance must be based on an average of samples taken that year under the provisions of subsection 12.7.1. If the average of these samples exceeds the MCL, the system must increase monitoring to once per quarter per treatment plant and such a system is not in violation of the MCL until it has completed one year of quarterly monitoring, unless the result of fewer than four quarters of monitoring will cause the running annual average to exceed the MCL, in which case the system is in violation at the end of that quarter. Systems required to increase monitoring frequency to quarterly monitoring must calculate compliance by including the sample that triggered the increased monitoring plus the following three quarters of monitoring.

12.13.2 Bromate. Compliance must be based on a running annual arithmetic average, computed quarterly, of monthly samples (or, for months in which the system takes more than one sample, the average of all samples taken during the month) collected by the system as prescribed by subsection 12.7.3. If the average of samples covering any consecutive four-quarter period exceeds the MCL, the system is in violation of the MCL and must notify the public pursuant to subsection 4.2, in addition to reporting to the Division pursuant to subsection 12.13. If a PWS fails to complete 12 consecutive months' monitoring, compliance with the MCL for the last four-quarter compliance period must be based on an average of the available data.

12.13.3 Chlorite. Compliance must be based on an arithmetic average of each three sample set taken in the distribution system as prescribed by subsection 12.7.2. If the arithmetic average of any three sample set exceeds the MCL, the system is in violation of the MCL and must notify the public pursuant to subsection 4.2, in addition to reporting to the Division pursuant to subsection 12.15.

12.14 Disinfectant residuals.

12.14.1 Chlorine and chloramines.

12.14.1.1 Compliance must be based on a running annual arithmetic average, computed quarterly, of monthly averages of all samples collected by the system under subsection 12.8.8.1. If the average of quarterly averages covering any consecutive four-quarter period exceeds the MRDL, the system is in violation of the MRDL and must notify the public pursuant to section 4.2, in addition to reporting to the Division pursuant to subsection 12.15.

12.14.1.2 In cases where systems switch between the use of chlorine and chloramines for residual disinfection during the year, compliance must be determined by including together all monitoring results of both chlorine and chloramines in calculating compliance. Reports submitted pursuant to subsection 12.6 must clearly indicate which residual disinfectant was analyzed for each sample.

12.14.2 Chlorine dioxide

12.14.2.1 Acute violations. Compliance must be based on consecutive daily samples collected by the system under subsection 12.8.2. If any daily sample taken at the entrance to the distribution system exceeds the MRDL, and on the following day one (or more) of the three samples taken in the distribution system exceed the MRDL, the system is in violation of the MRDL and must take immediate corrective action to lower the level of chlorine dioxide below the MRDL and must notify the public pursuant to the procedures for acute health risks in subsection 4.2 in addition to reporting to the Division pursuant to subsection 12.15. Failure to take samples in the distribution system the day following an exceedance of the chlorine dioxide MRDL at the entrance to the distribution system will also be considered an MRDL violation and the system must notify the public of the violation in accordance with the provisions for acute violations under subsection 4.2 in addition to reporting to the Division in accordance with subsection 12.15.

12.14.2.2 Non-acute violations. Compliance must be based on consecutive daily samples collected by the system under subsection 12.4.8.2. If any two consecutive daily samples taken at the entrance to the distribution system exceed the MRDL and all distribution system samples taken are below the MRDL, the system is in violation of the MRDL and must take corrective action to lower the level of chlorine dioxide below the MRDL at the point of sampling and will notify the public pursuant to the procedures for non-acute health risks in subsection 4.2 in addition to reporting to the Division pursuant to subsection 12.15. Failure to monitor at the entrance to the distribution system the day following an exceedance of the chlorine dioxide MRDL at the entrance to the distribution system is also an MRDL violation and the system must notify the public of the violation in accordance with the provisions for non-acute violations under subsection 4.2 in addition to reporting to the Division in accordance with subsection 12.15.

12.14.3 Disinfection byproduct precursors (DBPP). Compliance must be determined as specified by subsection 12.16.3. Systems may begin monitoring to determine whether Step 1 TOC removals can be met 12 months prior to the compliance date for the system. This monitoring is not required and failure to monitor during this period is not a violation. However, any system that does not monitor during this period, and then determines in the first 12 months after the compliance date that it is not able to meet the Step 1 requirements in subsection 12.16.2.2 and must therefore apply for alternate minimum TOC removal (Step 2) requirements, is not eligible for retroactive approval of alternate minimum TOC removal (Step 2) requirements as allowed pursuant to subsection 12.16.2.3 and is in violation. Systems may apply for alternate minimum TOC removal (Step 2) requirements any time after the compliance date. For systems required to meet Step 1 TOC removals, if the value calculated under subsection 12.16.3.1.4 is less than 1.00, the system is in violation of the treatment technique requirements and must notify the public pursuant to subsection 4.2, in addition to reporting to the Division pursuant to subsection 12.15.

12.15 Reporting and recordkeeping requirements:

12.15.1 Systems required to sample quarterly or more frequently must report to the Division within 10 days after the end of each quarter in which samples were collected, notwithstanding the provisions of subsections 4.1.1, 4.1.2, 4.1.3, 4.1.7 and 4.1.8. Systems required to sample less frequently than quarterly must report to the Division within 10 days after the end of each monitoring period in which samples were collected.

12.15.2 Disinfection byproducts. Systems must report the information specified in the following table:

12.15.3 Disinfectants. Systems must report the information specified in the following table:

12.15.4 Disinfection byproduct precursors and enhanced coagulation or enhanced softening. Systems must report the information specified in the following table:

12.16 Treatment Technique for Control of Disinfection Byproduct (DBP) Precursors:

12.16.1 Applicability.

12.16.1.1 Surface water or ground water under the direct influence of surface water systems using conventional filtration treatment (as defined in Section 1.0) must operate with enhanced coagulation or enhanced softening to achieve the TOC percent removal levels specified in subsection 12.16.2 unless the system meets at least one of the alternative compliance criteria listed in subsections 12.16.1.2 or 12.16.1.3.

12.16.1.2 Alternative compliance criteria for enhanced coagulation and enhanced softening systems. Surface water or ground water under the direct influence of surface water systems using conventional filtration treatment may use the alternative compliance criteria in subsections 12.16.1.2.1 through 12.16.1.2.6 to comply with this section in lieu of complying with subsection 12.16.2. Systems must still comply with monitoring requirements in subsection 12.9.

12.16.1.2.1 The system’s source water TOC level, measured according to 40 CFR 141.131(d)(3), is less than 2.0 mg/L, calculated quarterly as a running annual average.

12.16.1.2.2 The system’s treated water TOC level, measured according to 40 CFR 141.131(d)(3), is less than 2.0 mg/L, calculated quarterly as a running annual average.

12.16.1.2.3 The system's source water TOC level, measured as required by 40 CFR 141.131(d)(3), is less than 4.0 mg/L, calculated quarterly as a running annual average; the source water alkalinity, measured according to 40 CFR 141.131(d)(1), is greater than 60 mg/L (as CaCO3), calculated quarterly as a running annual average; and either the TTHM and HAA5 running annual averages are no greater than 0.040 mg/L and 0.030 mg/L, respectively; or prior to the effective date for compliance in subsection 12.2, the system has made a clear and irrevocable financial commitment not later than the effective date for compliance in subsection 12.2 to use of technologies that will limit the levels of TTHMs and HAA5 to no more than 0.040 mg/L and 0.030 mg/L, respectively. Systems must submit evidence of a clear and irrevocable financial commitment, in addition to a schedule containing milestones and periodic progress reports for installation and operation of appropriate technologies, to the Division for approval not later than the effective date for compliance in subsection 12.2. These technologies must be installed and operating not later than June 16, 2005. Failure to install and operate these technologies by the date in the approved schedule will constitute a violation of National Primary Drinking Water Regulations.

12.16.1.2.4 The TTHM and HAA5 running annual averages are no greater than 0.040 mg/L and 0.030 mg/L, respectively, and the system uses only chlorine for primary disinfection and maintenance of a residual in the distribution system.

12.16.1.2.5 The system's source water SUVA, prior to any treatment and measured monthly according to 40 CFR 141.131(d)(4), is less than or equal to 2.0 L/mg-m, calculated quarterly as a running annual average.

12.16.1.2.6 The system’s finished water SUVA, measured monthly according to 40 CFR 141.131(d)(4), is less than or equal to 2.0 L/mg-m, calculated quarterly as a running annual average.

12.16.1.3 Additional alternative compliance criteria for softening systems. Systems practicing enhanced softening that cannot achieve the TOC removals required by subsection 12.16.2.2 may use the alternative compliance criteria in subsections 12.16.1.3.1 and 12.16.1.3.2 in lieu of complying with subsection 12.16.2. Systems must still comply with monitoring requirements in subsection 12.9.

12.16.1.3.1 Softening that results in lowering the treated water alkalinity to less than 60 mg/L (as CaCO3), measured monthly according to 40 CFR 141.131(d)(1) and calculated quarterly as a running annual average.

12.16.1.3.2 Softening that results in removing at least 10 mg/L of magnesium hardness (as CaCO3), measured monthly according to subsection 12.2.2 and calculated quarterly as an annual running average.

12.16.2 Enhanced coagulation and enhanced softening performance requirements.

12.16.2.1 Systems must achieve the percent reduction of TOC specified in subsection 12.16.2.2 between the source water and the combined filter effluent, unless the Division approves a system's request for alternate minimum TOC removal (Step 2) requirements under subsection 12.16.2.3.

12.16.2.2 Required Step 1 TOC reductions, indicated in the following table, are based upon specified source water parameters measured in accordance with 40 CFR 141.131(d). Systems practicing softening are required to meet the Step 1 TOC reductions in the far-right column (Source water alkalinity >120 mg/L) for the specified source water TOC:

Step 1 Required Removal of TOC by Enhanced Coagulation and Enhanced Softening for Subpart H Systems Using Conventional Treatment1,2

12.16.2.3 Surface water or ground water under the direct influence of surface water conventional treatment systems that cannot achieve the Step 1 TOC removals required by subsection 12.16.2.2 due to water quality parameters or operational constraints must apply to the Division, within three months of failure to achieve the TOC removals required by subsection 12.16.2.2, for approval of alternative minimum TOC (Step 2) removal requirements submitted by the system. If the Division approves the alternative minimum TOC removal (Step 2) requirements, the Division may make those requirements retroactive for the purposes of determining compliance. Until the Division approves the alternate minimum TOC removal (Step 2) requirements, the system must meet the Step 1 TOC removals contained in subsection 12.16.2.2.

12.16.2.4 Alternate minimum TOC removal (Step 2) requirements. Applications made to the Division by enhanced coagulation systems for approval of alternative minimum TOC removal (Step 2) requirements under subsection 12.16.2.3 must include, as a minimum, results of bench- or pilot-scale testing conducted under subsection 12.16.2.4.1 and used to determine the alternate enhanced coagulation level.

12.16.2.4.1 Alternate enhanced coagulation level is defined as coagulation at a coagulant dose and pH as determined by the method described in subsections 12.16.2.4.1 through 12.16.2.4.5 such that an incremental addition of 10 mg/L of alum (as aluminum) (or equivalent amount of ferric salt) results in a TOC removal of ≤ 0.3 mg/L. The percent removal of TOC at this point on the ``TOC removal versus coagulant dose'' curve is then defined as the minimum TOC removal required for the system. Once approved by the Division, this minimum requirement supersedes the minimum TOC removal required by the table in subsection 12.16.2.2. This requirement will be effective until such time as the Division approves a new value based on the results of a new bench- and pilot-scale test. Failure to achieve Division-set alternative minimum TOC removal levels is a violation of National Primary Drinking Water Regulations.

12.16.2.4.2 Bench- or pilot-scale testing of enhanced coagulation must be conducted by using representative water samples and adding 10 mg/L increments of alum (as aluminum) (or equivalent amounts of ferric salt) until the pH is reduced to a level less than or equal to the enhanced coagulation Step 2 target pH shown in the following table:

Enhanced Coagulation Step 2 Target pH

12.16.2.4.3 For waters with alkalinities of less than 60 mg/L for which addition of small amounts of alum or equivalent addition of iron coagulant drives the pH below 5.5 before significant TOC removal occurs, the system must add necessary chemicals to maintain the pH between 5.3 and 5.7 in samples until the TOC removal of 0.3 mg/L per 10 mg/L alum added (as aluminum) (or equivalent addition of iron coagulant) is reached.

12.16.2.4.4 The system may operate at any coagulant dose or pH necessary (consistent with other NPDWRs) to achieve the minimum TOC percent removal approved under subsection 12.16.2.3.

12.16.2.4.5 If the TOC removal is consistently less than 0.3 mg/L of TOC per 10 mg/L of incremental alum dose (as aluminum) at all dosages of alum (or equivalent addition of iron coagulant), the water is deemed to contain TOC not amenable to enhanced coagulation. The system may then apply to the Division for a waiver of enhanced coagulation requirements.

12.16.3 Compliance Calculations:

12.16.3.1 Surface water or ground water under the direct influence of surface water systems other than those identified in subsections 12.16.1.2 or 12.16.1.3 must comply with requirements contained in subsections 12.16.2.2 or 12.16.2.3. Systems must calculate compliance quarterly, beginning after the system has collected 12 months of data, by determining an annual average using the following method:

12.16.3.1.1 Determine actual monthly TOC removal, equal to: (1-(treated water TOC/source water TOC)) X 100.

12.16.3.1.2 Determine the required monthly TOC percent removal (from either the table in subsection 12.16.2.2 or from subsection 12.16.2.3).

12.16.3.1.3 Divide the value in subsection 12.16.3.1.1 by the value in subsection 12.16.3.1.2.

12.16.3.1.4 Add together the results of subsection 12.16.3.1.3 for the last 12 months and divide by 12.

12.16.3.1.5 If the value calculated in subsection 12.16.3.1.4 is less than 1.00, the system is not in compliance with the TOC percent removal requirements.

12.16.3.2 Systems may use the provisions in subsections 12.16.3.2.1 through 12.16.3.2.5 in lieu of the calculations in subsections 12.16.3.1.1 through 12.16.3.1.5 to determine compliance with TOC percent removal requirements.

12.16.3.2.1 In any month that the system's treated or source water TOC level, measured according to 40 CFR 141.131(d)(3), is less than 2.0 mg/L, the system may assign a monthly value of 1.0 (in lieu of the value calculated in subsection 12.16.3.1.3) when calculating compliance under the provisions of subsection 12.16.3.1.

12.16.3.2.2 In any month that a system practicing softening removes at least 10 mg/L of magnesium hardness (as CaCO3), the system may assign a monthly value of 1.0 (in lieu of the value calculated in subsection 12.16.3.1.3) when calculating compliance under the provisions of subsection 12.16.3.1.

12.16.3.2.3 In any month that the system's source water SUVA, prior to any treatment and measured according to 40 CFR 141.131(d)(4), is ≤2.0 L/mg-m, the system may assign a monthly value of 1.0 (in lieu of the value calculated in subsection 12.16.3.1.3) when calculating compliance under the provisions of subsection 12.16.3.1.

12.16.3.2.4 In any month that the system's finished water SUVA, measured according to 40 CFR 141.131(d)(4), is ≤2.0 L/mg-m, the system may assign a monthly value of 1.0 (in lieu of the value calculated in subsection 12.16.3.1.3) when calculating compliance under the provisions of subsection 12.16.3.1.

12.16.3.2.5 In any month that a system practicing enhanced softening lowers alkalinity below 60 mg/L (as CaCO3), the system may assign a monthly value of 1.0 (in lieu of the value calculated in subsection 12.16.3.1.3) when calculating compliance under the provisions of subsection 12.16.3.1.

12.16.3.3 Surface water or ground water under the direct influence of surface water systems using conventional treatment may also comply with the requirements of this section by meeting the criteria in subsection 12.16.1.2 or 12.16.1.3.

12.16.4 Treatment technique requirements for DBP precursors. The Division identifies the following as treatment techniques to control the level of disinfection byproduct precursors in drinking water treatment and distribution systems:

12.16.4.1 For Surface water or ground water under the direct influence of surface water systems using conventional treatment, enhanced coagulation or enhanced softening.

**History**
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *25 DE Reg. 713 (01/01/22)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *5 DE Reg. 2121 (05/01/02)*
- *9 DE Reg. 999 (12/01/05)*
- *15 DE Reg. 73 (07/01/12)*
- *17 DE Reg. 439 (10/01/13)*
- *19 DE Reg. 517 (12/01/15)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *25 DE Reg. 713 (01/01/22)*

##### **16 Del. Admin. Code § 4462-13.0** Initial Distribution System Evaluations {#sec-4462-13.0 omnilex-key=us-de-regs-official--title-16--4462-13.0}

13.1 General requirements.

13.1.1 The requirements of Section 13.0 constitute national primary drinking water regulations. The regulations in this subpart establish monitoring and other requirements for identifying Section 14.0 compliance monitoring locations for determining compliance with maximum contaminant levels for total trihalomethanes (TTHM) and haloacetic acids (five)(HAA5). You must use an Initial Distribution System Evaluation (IDSE) to determine locations with representative high TTHM and HAA5 concentrations throughout your distribution system. IDSEs are used in conjunction with, but separate from, Section 12.0 compliance monitoring, to identify and select Section 14.0 compliance monitoring locations.

13.1.2 Applicability. You are subject to these requirements if your system is a community water system that uses a primary or residual disinfectant other than ultraviolet light or delivers water that has been treated with a primary or residual disinfectant other than ultraviolet light; or if your system is a non-transient non-community water system that serves at least 10,000 people and uses a primary or residual disinfectant other than ultraviolet light or delivers water that has been treated with a primary or residual disinfectant other than ultraviolet light.

13.1.3 Schedule.

13.1.3.1 You must comply with the requirements of this section on the schedule in the table in this paragraph.

13.1.3.2 For the purpose of the schedule in subsection 13.1.3.1, the Division may determine that the combined distribution system does not include certain consecutive systems based on factors such as receiving water from a wholesale system only on an emergency basis or receiving only a small percentage and small volume of water from a wholesale system. The Division may also determine that the combined distribution system does not include certain wholesale systems based on factors such as delivering water to a consecutive system only on an emergency basis or delivering only a small percentage and small volume of water to a consecutive system.

13.1.4 You must conduct standard monitoring that meets the requirements in subsection 13.2, or a system specific study that meets the requirements in subsection 13.3, or certify to the Division that you meet 40/30 certification criteria under subsection 13.4, or qualify for a very small system waiver under subsection 13.5.

13.1.4.1 You must have taken the full complement of routine TTHM and HAA5 compliance samples required of a system with your population and source water under Section 12.0 of this part (or you must have taken the full complement of reduced TTHM and HAA5 compliance samples required of a system with your population and source water under subsection 12.7.1.1 if you meet reduced monitoring criteria under subsection 12.7.1.2 of this part) during the period specified in subsection 13.4.1 to meet the 40/30 certification criteria in subsection 13.4. You must have taken TTHM and HAA5 samples under subsections 12.6 to be eligible for the very small system waiver in subsection 13.5.

13.1.4.2 If you have not taken the required samples, you must conduct standard monitoring that meets the requirements in subsection 13.2, or a system specific study that meets the requirements in subsection 13.3.

13.1.5 You must use only the analytical methods specified in subsection 12.5.1, or otherwise approved by EPA for monitoring under this section, to demonstrate compliance with the requirements of this section.

13.1.6 IDSE results will not be used for the purpose of determining compliance with MCLs in subsection 9.2.1.2.

13.2 Standard monitoring.

13.2.1 Standard monitoring plan. Your standard monitoring plan must comply with subsections 13.2.1 through 13.2.1.4. You must prepare and submit your standard monitoring plan to the Division according to the schedule in subsection 13.1.3.

13.2.1.1 Your standard monitoring plan must include a schematic of your distribution system (including distribution system entry points and their sources, and storage facilities), with notes indicating locations and dates of all projected standard monitoring, and all projected compliance monitoring in subsection 12.6.

13.2.1.2 Your standard monitoring plan must include justification of standard monitoring location selection and a summary of data you relied on to justify standard monitoring location selection.

13.2.1.3 Your standard monitoring plan must specify the population served and system type (surface water or ground water under the direct influence of surface water or ground water).

13.2.1.4 You must retain a complete copy of your standard monitoring plan submitted under subsection 13.2.1, including any Division modification of your standard monitoring plan, for as long as you are required to retain your IDSE report under subsection 13.2.3.4.

13.2.2 Standard monitoring.

13.2.2.1 You must monitor as indicated in the table in this subsection 13.2.2.1. You must collect dual sample sets at each monitoring location. One sample in the dual sample set must be analyzed for TTHM. The other sample in the dual sample set must be analyzed for HAA5. You must conduct one monitoring period during the peak historical month for TTHM levels or HAA5 levels or the month of warmest water temperature. You must review available compliance, study, or operational data to determine the peak historical month for TTHM or HAA5 levels or warmest water temperature.

13.2.2.2 You must take samples at locations other than the existing monitoring locations in subsection 12.4. Monitoring locations must be distributed throughout the distribution system.

13.2.2.3 If the number of entry points to the distribution system is fewer than the specified number of entry point monitoring locations, excess entry point samples must be replaced equally at high TTHM and HAA5 locations. If there is an odd extra location number, you must take a sample at a high TTHM location. If the number of entry points to the distribution system is more than the specified number of entry point monitoring locations, you must take samples at entry points to the distribution system having the highest annual water flows.

13.2.2.4 Your monitoring under this subsection 13.2.2 may not be reduced under the provisions of subsection 1.16.2.

13.2.3 IDSE report. Your IDSE report must include the elements required in subsections 13.2.3.1 through 13.2.3.4. You must submit your IDSE report to the Division according to the schedule in subsection 13.1.3.

13.2.3.1 Your IDSE report must include all TTHM and HAA5 analytical results from compliance monitoring under subsection 12.6 and all standard monitoring conducted during the period of the IDSE as individual analytical results and LRAAs presented in a tabular or spreadsheet format acceptable to the Division. If changed from your standard monitoring plan submitted under subsection 13.1, your report must also include a schematic of your distribution system, the population served, and system type (Surface water or ground water under the direct influence of surface water or ground water).

13.2.3.2 Your IDSE report must include an explanation of any deviations from your approved standard monitoring plan.

13.2.3.3 You must recommend and justify compliance monitoring locations and timing under Section 14.0 based on the protocol in subsection 13.6.

13.2.3.4 You must retain a complete copy of your IDSE report submitted under this section for 10 years after the date that you submitted your report. If the Division modifies the monitoring requirements under Section 14.0 that you recommended in your IDSE report or if the Division approves alternative monitoring locations, you must keep a copy of the Division's notification on file for 10 years after the date of the Division's notification. You must make the IDSE report and any Division notification available for review by the Division or the public.

13.3 System specific studies.

13.3.1 System specific study plan. Your system specific study plan must be based on either existing monitoring results as required under subsection 13.1.1 or modeling as required under subsection 13.1.2. You must prepare and submit your system specific study plan to the Division according to the schedule in subsection 13.1.3.

13.3.1.1 Existing monitoring results. You may comply by submitting monitoring results collected before you are required to begin monitoring under subsection 13.1.3. The monitoring results and analysis must meet the criteria in subsections 13.3.1.1.1 and 13.3.1.1.2.

13.3.1.1.1 Minimum requirements.

13.3.1.1.1.1 TTHM and HAA5 results must be based on samples collected and analyzed in accordance with subsection 12.5.1. Samples must be collected no earlier than five years prior to the study plan submission date.

13.3.1.1.1.2 The monitoring locations and frequency must meet the conditions identified in this subsection 13.3.1.1.1.2. Each location must be sampled once during the peak historical month for TTHM levels or HAA5 levels or the month of warmest water temperature for every 12 months of data submitted for that location. Monitoring results must include all compliance monitoring results under subsection 12.6 plus additional monitoring results as necessary to meet minimum sample requirements.

13.3.1.1.2 Reporting monitoring results. You must report the information in this subsection 13.3.1.1.2.

13.3.1.1.2.1 You must report previously collected monitoring results and certify that the reported monitoring results include all compliance and non-compliance results generated during the time period beginning with the first reported result and ending with the most recent results collected under subsection 12.6.

13.3.1.1.2.2 You must certify that the samples were representative of the entire distribution system and that the treatment and distribution system have not changed significantly since the samples were collected.

13.3.1.1.2.3 Your study monitoring plan must include a schematic of your distribution system (including distribution system entry points and their sources, and storage facilities), with notes indicating the locations and dates of all completed or planned system specific study monitoring.

13.3.1.1.2.4 Your system specific study plan must specify the population served and system type (Surface water or ground water under the direct influence of surface water or ground water).

13.3.1.1.2.5 You must retain a complete copy of your system specific study plan submitted under this subsection 13.3.1.1, including any Division modification of your system specific study plan, for as long as you are required to retain your IDSE report under subsection 13.3.2.5.

13.3.1.1.2.6 If you submit previously collected data that fully meet the number of samples required under subsection 13.3.1.1.1.2 and the Division rejects some of the data, you must either conduct additional monitoring to replace rejected data on a schedule the Division approves or conduct standard monitoring under subsection 13.2.

13.3.1.2 Modeling. You may comply through analysis of an extended period simulation hydraulic model. The extended period simulation hydraulic model and analysis must meet the criteria in this subsection 13.3.1.2.

13.3.1.2.1 Minimum requirements.

13.3.1.2.1.1 The model must simulate 24 hour variation in demand and show a consistently repeating 24 hour pattern of residence time.

13.3.1.2.1.2 The model must represent the criteria listed in subsections 13.3.1.2.1.2.1 through 13.3.1.2.1.2.9.

13.3.1.2.1.2.1 75% of pipe volume;

13.3.1.2.1.2.2 50% of pipe length;

13.3.1.2.1.2.3 All pressure zones;

13.3.1.2.1.2.4 All 12-inch diameter and larger pipes;

13.3.1.2.1.2.5 All 8-inch and larger pipes that connect pressure zones, influence zones from different sources, storage facilities, major demand areas, pumps, and control valves, or are known or expected to be significant conveyors of water;

13.3.1.2.1.2.6 All 6-inch and larger pipes that connect remote areas of a distribution system to the main portion of the system;

13.3.1.2.1.2.7 All storage facilities with standard operations represented in the model; and

13.3.1.2.1.2.8 All active pump stations with controls represented in the model; and

13.3.1.2.1.2.9 All active control valves.

13.3.1.2.1.3 The model must be calibrated, or have calibration plans, for the current configuration of the distribution system during the period of high TTHM formation potential. All storage facilities must be evaluated as part of the calibration process. All required calibration must be completed no later than 12 months after plan submission.

13.3.1.2.2 Reporting modeling. Your system specific study plan must include the information in this subsection 13.3.1.2.2.

13.3.1.2.2.1 Tabular or spreadsheet data demonstrating that the model meets requirements in subsection 13.3.1.2.1.2.

13.3.1.2.2.2 A description of all calibration activities undertaken, and if calibration is complete, a graph of predicted tank levels versus measured tank levels for the storage facility with the highest residence time in each pressure zone, and a time series graph of the residence time at the longest residence time storage facility in the distribution system showing the predictions for the entire simulation period (i.e., from time zero until the time it takes to for the model to reach a consistently repeating pattern of residence time).

13.3.1.2.2.3 Model output showing preliminary 24 hour average residence time predictions throughout the distribution system.

13.3.1.2.2.4 Timing and number of samples representative of the distribution system planned for at least one monitoring period of TTHM and HAA5 dual sample monitoring at a number of locations no less than would be required for the system under standard monitoring in subsection 13.2 during the historical month of high TTHM. These samples must be taken at locations other than existing compliance monitoring locations in subsection 12.6.

13.3.1.2.2.5 Description of how all requirements will be completed no later than 12 months after you submit your system specific study plan.

13.3.1.2.2.6 Schematic of your distribution system (including distribution system entry points and their sources, and storage facilities), with notes indicating the locations and dates of all completed system specific study monitoring (if calibration is complete) and all compliance monitoring under subsection 12.6.

13.3.1.2.2.7 Population served and system type (Surface water or ground water under the direct influence of surface water or ground water).

13.3.1.2.2.8 You must retain a complete copy of your system specific study plan submitted under this subsection 13.3.1.2, including any Division modification of your system specific study plan, for as long as you are required to retain your IDSE report under subsection 13.3.1.2.7.

13.3.1.2.3 If you submit a model that does not fully meet the requirements under subsection 13.3.1.2, you must correct the deficiencies and respond to Division inquiries concerning the model. If you fail to correct deficiencies or respond to inquiries to the Division's satisfaction, you must conduct standard monitoring under subsection 13.2.

13.3.2 IDSE report. Your IDSE report must include the elements required in subsections 13.3.2.1 through 13.3.2.6. You must submit your IDSE report according to the schedule in subsection 13.1.3.

13.3.2.1 Your IDSE report must include all TTHM and HAA5 analytical results from compliance monitoring under subsection 12.6 and all system specific study monitoring conducted during the period of the system specific study presented in a tabular or spreadsheet format acceptable to the Division. If changed from your system specific study plan submitted under subsection 13.3, your IDSE report must also include a schematic of your distribution system, the population served, and system type (Surface water or ground water under the direct influence of surface water or ground water).

13.3.2.2 If you used the modeling provision under subsection 13.3.1.2, you must include final information for the elements described in subsection 13.3.1.2.2, and a 24-hour time series graph of residence time for each compliance monitoring location selected under Section 14.0.

13.3.2.3 You must recommend and justify compliance monitoring locations under Section 14.0 and timing based on the protocol in subsection 13.6.

13.3.2.4 Your IDSE report must include an explanation of any deviations from your approved system specific study plan.

13.3.2.5 Your IDSE report must include the basis (analytical and modeling results) and justification you used to select the recommended monitoring locations under section 14.0.

13.3.2.6 You may submit your IDSE report in lieu of your system specific study plan on the schedule identified in subsection 13.1.3 for submission of the system specific study plan if you believe that you have the necessary information by the time that the system specific study plan is due. If you elect this approach, your IDSE report must also include all information required under subsection 13.3.1.

13.3.2.7 You must retain a complete copy of your IDSE report submitted under this section for 10 years after the date that you submitted your IDSE report. If the Division modifies the monitoring requirements under section 14.0 that you recommended in your IDSE report or if the Division approves alternative monitoring locations, you must keep a copy of the Division's notification on file for 10 years after the date of the Division's notification. You must make the IDSE report and any Division notification available for review by the Division or the public.

13.4 40/30 certification.

13.4.1 Eligibility. You are eligible for 40/30 certification if you had no TTHM or HAA5 monitoring violations under subsection 12.7 of this part and no individual sample exceeded 0.040 mg/L for TTHM or 0.030 mg/L for HAA5 during an eight consecutive calendar quarter period beginning no earlier than the date specified in this subsection (13.4.1).

13.4.2 40/30 certification.

13.4.2.1 You must certify to your Division that every individual compliance sample taken under subsection 12.7.1 of this part during the periods specified in subsection 13.4.1 were ≤0.040 mg/L for TTHM and ≤0.030 mg/L for HAA5, and that you have not had any TTHM or HAA5 monitoring violations during the period specified in subsection 13.4.1.

13.4.2.2 The Division may require you to submit compliance monitoring results, distribution system schematics, and/or recommended compliance monitoring under Section 14.0 locations in addition to your certification. If you fail to submit the requested information, the Division may require standard monitoring under subsection 13.2 or a system specific study under subsection 13.3.

13.4.2.3 The Division may still require standard monitoring under subsection 13.2 or a system specific study under subsection 13.3 even if you meet the criteria in subsection 13.4.1.

13.4.2.4 You must retain a complete copy of your certification submitted under this section for 10 years after the date that you submitted your certification. You must make the certification, all data upon which the certification is based, and any Division notification available for review by the Division or the public.

13.5 Very small system waivers.

13.5.1 If you serve fewer than 500 people and you have taken TTHM and HAA5 samples under subsection 12.7 of this part, you are not required to comply with this section unless the Division notifies you that you must conduct standard monitoring under subsection 13.2 or a system specific study under subsection 13.3.

13.5.2 If you have not taken TTHM and HAA5 samples under subsection 12.7.1 of this part or if the Division notifies you that you must comply with this section, you must conduct standard monitoring under subsection 13.2 or a system specific study under subsection 13.3.

13.6 Compliance monitoring location recommendations.

13.6.1 Your IDSE report must include your recommendations and justification for where and during what month(s) TTHM and HAA5 monitoring for Section 14.0 of this part should be conducted. You must base your recommendations on the criteria in subsections 13.6.2 through 13.6.5.

13.6.2 You must select the number of monitoring locations specified in the table in this subsection 13.6.2. You will use these recommended locations as routine compliance monitoring locations for Section 14.0, unless the Division requires different or additional locations. You should distribute locations throughout the distribution system to the extent possible.

13.6.3 You must recommend compliance monitoring locations under Section 14.0 based on standard monitoring results, system specific study results, and compliance monitoring results under subsection 12.4. You must follow the protocol in subsections 13.6.3.1 through 13.6.3.7. If required to monitor at more than eight locations, you must repeat the protocol as necessary. If you do not have existing compliance monitoring results from subsection 12.6 or if you do not have enough existing compliance monitoring results from subsection 12.7, you must repeat the protocol, skipping the provisions of subsections 13.6.3.3 and 13.6.3.7 as necessary, until you have identified the required total number of monitoring locations.

13.6.3.1 Location with the highest TTHM LRAA not previously selected as a monitoring location under Section 14.0.

13.6.3.2 Location with the highest HAA5 LRAA not previously selected as a monitoring location under Section 14.0.

13.6.3.3 Existing average residence time compliance monitoring location under subsection 12.7.1 (maximum residence time compliance monitoring location for ground water systems) with the highest HAA5 LRAA not previously selected as a monitoring location under Section 14.0.

13.6.3.4 Location with the highest TTHM LRAA not previously selected as a monitoring location under Section 14.0.

13.6.3.5 Location with the highest TTHM LRAA not previously selected as a monitoring location under Section 14.0.

13.6.3.6 Location with the highest HAA5 LRAA not previously selected as a monitoring location under Section 14.0.

13.6.3.7 Existing average residence time compliance monitoring location under subsection 12.7.1 (maximum residence time compliance monitoring location for ground water systems) with the highest TTHM LRAA not previously selected as a monitoring location under Section 14.0.

13.6.3.8 Location with the highest HAA5 LRAA not previously selected as a monitoring location under Section 14.0.

13.6.4 You may recommend locations other than those specified in subsection 13.6.3 if you include a rationale for selecting other locations. If the Division approves the alternate locations, you must monitor at these locations to determine compliance under Section 14.0 of this part.

13.6.5 Your recommended schedule must include monitoring under Section 14.0 during the peak historical month for TTHM and HAA5 concentration, unless the Division approves another month. Once you have identified the peak historical month, and if you are required to conduct routine monitoring at least quarterly, you must schedule compliance monitoring under Section 14.0 at a regular frequency of every 90 days or fewer.

**History**
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *25 DE Reg. 713 (01/01/22)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *5 DE Reg. 2121 (05/01/02)*
- *9 DE Reg. 999 (12/01/05)*
- *15 DE Reg. 73 (07/01/12)*
- *17 DE Reg. 439 (10/01/13)*
- *19 DE Reg. 517 (12/01/15)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *25 DE Reg. 713 (01/01/22)*

##### **16 Del. Admin. Code § 4462-14.0** Stage 2 Disinfection Byproducts Requirements {#sec-4462-14.0 omnilex-key=us-de-regs-official--title-16--4462-14.0}

14.1 General requirements.

14.1.1 General. The requirements of Section 14.0 constitute national primary drinking water regulations. The regulations in this section establish monitoring and other requirements for achieving compliance with maximum contaminant levels based on locational running annual averages (LRAA) for total trihalomethanes (TTHM) and haloacetic acids (five)(HAA5), and for achieving compliance with maximum residual disinfectant residuals for chlorine and chloramine for certain consecutive systems.

14.1.2 Applicability. You are subject to these requirements if your system is a community water system or a non-transient non-community water system that uses a primary or residual disinfectant other than ultraviolet light or delivers water that has been treated with a primary or residual disinfectant other than ultraviolet light.

14.1.3 Schedule. You must comply with the requirements in this section on the schedule in the following table based on your system type.

14.1.3.6 Your monitoring frequency is specified in subsection 14.2.1.2.

14.1.3.6.1 If you are required to conduct quarterly monitoring, you must begin monitoring in the first full calendar quarter that includes the compliance date in the table in this subsection 14.1.3.

14.1.3.6.2 If you are required to conduct monitoring at a frequency that is less than quarterly, you must begin monitoring in the calendar month recommended in the IDSE report prepared under subsections 13.2 or 13.3 or the calendar month identified in the monitoring plan developed under subsection 14.3 no later than 12 months after the compliance date in this table.

14.1.3.7 If you are required to conduct quarterly monitoring, you must make compliance calculations at the end of the fourth calendar quarter that follows the compliance date and at the end of each subsequent quarter (or earlier if the LRAA calculated based on fewer than four quarters of data would cause the MCL to be exceeded regardless of the monitoring results of subsequent quarters). If you are required to conduct monitoring at a frequency that is less than quarterly, you must make compliance calculations beginning with the first compliance sample taken after the compliance date.

14.1.3.8 For the purpose of the schedule in this subsection 14.1.3, the Division may determine that the combined distribution system does not include certain consecutive systems based on factors such as receiving water from a wholesale system only on an emergency basis or receiving only a small percentage and small volume of water from a wholesale system. The Division may also determine that the combined distribution system does not include certain wholesale systems based on factors such as delivering water to a consecutive system only on an emergency basis or delivering only a small percentage and small volume of water to a consecutive system.

14.1.4 Monitoring and compliance.

14.1.4.1 Systems required to monitor quarterly. Under Section 14.0 in order to comply with MCLs in subsection 9.2.1.2, you must calculate LRAAs for TTHM and HAA5 using monitoring results collected under this section and determine that each LRAA does not exceed the MCL. If you fail to complete four consecutive quarters of monitoring, you must calculate compliance with the MCL based on the average of the available data from the most recent four quarters. If you take more than one sample per quarter at a monitoring location, you must average all samples taken in the quarter at that location to determine a quarterly average to be used in the LRAA calculation.

14.1.4.2 Systems required to monitor yearly or less frequently. Under Section 14.0 to determine compliance with MCLs in subsection 9.2.1.2, you must determine that each sample taken is less than the MCL. If any sample exceeds the MCL, you must comply with the requirements of subsection 14.6. If no sample exceeds the MCL, the sample result for each monitoring location is considered the LRAA for that monitoring location.

14.1.5 Violation. You are in violation of the monitoring requirements for each quarter that a monitoring result would be used in calculating an LRAA if you fail to monitor.

14.2 Routine monitoring.

14.2.1 Monitoring.

14.2.1.1 If you submitted an IDSE report, you must begin monitoring at the locations and months you have recommended in your IDSE report submitted under subsection 13.6 following the schedule in subsection 14.1.3, unless the Division requires other locations or additional locations after its review. If you submitted a 40/30 certification under subsection 13.4 or you qualified for a very small system waiver under subsection 13.5 or you are a non-transient non-community water system serving <10,000, you must monitor at the location(s) and dates identified in your monitoring plan in subsection 12.6, updated as required by subsection 14.3.

14.2.1.2 You must monitor at no fewer than the number of locations identified in this subsection 14.2.1.2.

14.2.1.3 If you are an undisinfected system that begins using a disinfectant other than UV light after the dates in Section 13.0 for complying with the Initial Distribution System Evaluation requirements, you must consult with the Division to identify compliance monitoring locations for this section. You must then develop a monitoring plan under subsection 14.3 that includes those monitoring locations.

14.2.2 Analytical methods. You must use an approved method listed in subsection 12.5.1 for TTHM and HAA5 analyses in this section. Analyses must be conducted by laboratories that have received certification by EPA or the Division as specified in subsection 12.5.1.

14.3 Monitoring plan.

14.3.1 You must develop and implement a monitoring plan to be kept on file for Division and public review. The monitoring plan must contain the elements in subsections 14.3.1.1.1 through 14.3.1.1.4 and be complete no later than the date you conduct your initial monitoring under this section.

14.3.1.1 Monitoring locations;

14.3.1.2 Monitoring dates;

14.3.1.3 Compliance calculation procedures; and

14.3.1.4 Monitoring plans for any other systems in the combined distribution system if the Division has reduced monitoring requirements under the Division authority in the 40 CFR section 142.16(m) (Copies available at the Office of Drinking Water upon request).

14.3.2 If you were not required to submit an IDSE report under either subsection 13.2 or subsection 13.3, and you do not have sufficient Section 12.0 monitoring locations to identify the required number of Section 14.0 compliance monitoring locations indicated in subsection 13.6.2, you must identify additional locations by alternating selection of locations representing high TTHM levels and high HAA5 levels until the required number of compliance monitoring locations have been identified. You must also provide the rationale for identifying the locations as having high levels of TTHM or HAA5. If you have more Section 12.0 monitoring locations than required for Section 14.0 compliance monitoring in subsection 13.6.2, you must identify which locations you will use for Section 14.0 compliance monitoring by alternating selection of locations representing high TTHM levels and high HAA5 levels until the required number of Section 14.0 compliance monitoring locations have been identified.

14.3.3 If you are a surface water or ground water under the direct influence of surface water system serving >3,300 people, you must submit a copy of your monitoring plan to the Division prior to the date you conduct your initial monitoring under this section, unless your IDSE report submitted under Section 13.0 of this part contains all the information required by this section.

14.3.4 You may revise your monitoring plan to reflect changes in treatment, distribution system operations and layout (including new service areas), or other factors that may affect TTHM or HAA5 formation, or for Division-approved reasons, after consultation with the Division regarding the need for changes and the appropriateness of changes. If you change monitoring locations, you must replace existing compliance monitoring locations with the lowest LRAA with new locations that reflect the current distribution system locations with expected high TTHM or HAA5 levels. The Division may also require modifications in your monitoring plan. If you are a surface water or ground water under the direct influence of surface water system serving >3,300 people, you must submit a copy of your modified monitoring plan to the Division prior to the date you are required to comply with the revised monitoring plan.

14.4 Reduced monitoring.

14.4.1 You may reduce monitoring to the level specified in the table in this section any time the LRAA is ≤0.040 mg/L for TTHM and ≤0.030 mg/l for HAA5 at all monitoring locations. You may only use data collected under the provisions of this Section, 14.0 or Section 12.0 of this part to qualify for reduced monitoring. In addition, the source water annual average TOC level, before any treatment, must be ≤4.0 mg/L at each treatment plant treating surface water or ground water under the direct influence of surface water, based on monitoring conducted under either subsection 12.7.1.3 or subsection 12.9.

14.4.2 You may remain on reduced monitoring as long as the TTHM LRAA ≤0.040 mg/L and the HAA5 LRAA ≤0.030 mg/L at each monitoring location (for systems with quarterly reduced monitoring) or each TTHM sample ≤0.060 mg/L and each HAA5 sample ≤0.045 mg/L (for systems with annual or less frequent monitoring). In addition, the source water annual average TOC level, before any treatment, must be ≤4.0 mg/L at each treatment plant treating surface water or ground water under the direct influence of surface water, based on monitoring conducted under either subsections 12.7.1.3 or 12.9.

14.4.3 If the LRAA based on quarterly monitoring at any monitoring location exceeds either 0.040 mg/L for TTHM or 0.030 mg/L for HAA5 or if the annual (or less frequent) sample at any location exceeds either 0.060 mg/L for TTHM or 0.045 mg/L for HAA5, or if the source water annual average TOC level, before any treatment, >4.0 mg/L at any treatment plant treating surface water or ground water under the direct influence of surface water, you must resume routine monitoring under subsection 14.2 or begin increased monitoring if subsection 14.6 applies.

14.4.4 The Division may return your system to routine monitoring at the Division's discretion.

14.5 Additional requirements for consecutive systems. If you are a consecutive system that does not add a disinfectant but delivers water that has been treated with a primary or residual disinfectant other than ultraviolet light, you must comply with analytical and monitoring requirements for chlorine and chloramines in subsections 12.5.1 and 12.8.1 and the compliance requirements in subsection 12.14.3.1 beginning April 1, 2009, unless required earlier by the Division, and report monitoring results under subsection 12.15.

14.6 Conditions requiring increased monitoring.

14.6.1 If you are required to monitor at a particular location annually or less frequently than annually under subsections 14.2 or 14.4, you must increase monitoring to dual sample sets once per quarter (taken every 90 days) at all locations if a TTHM sample is >0.080 mg/L or a HAA5 sample is >0.060 mg/L at any location.

14.6.2 You are in violation of the MCL when the LRAA exceeds the section 14.0 MCLs in subsection 9.2.1.2, calculated based on four consecutive quarters of monitoring (or the LRAA calculated based on fewer than four quarters of data if the MCL would be exceeded regardless of the monitoring results of subsequent quarters). You are in violation of the monitoring requirements for each quarter that a monitoring result would be used in calculating an LRAA if you fail to monitor.

14.6.3 You may return to routine monitoring once you have conducted increased monitoring for at least four consecutive quarters and the LRAA for every monitoring location is <0.060 mg/L for TTHM and <0.045 mg/L for HAA5.

14.7 Operational evaluation levels.

14.7.1 You have exceeded the operational evaluation level at any monitoring location where the sum of the two previous quarters' TTHM results plus twice the current quarter's TTHM result, divided by 4 to determine an average, exceeds 0.080 mg/L, or where the sum of the two previous quarters' HAA5 results plus twice the current quarter's HAA5 result, divided by 4 to determine an average, exceeds 0.060 mg/L.

14.7.2.1 If you exceed the operational evaluation level, you must conduct an operational evaluation and submit a written report of the evaluation to the Division no later than 90 days after being notified of the analytical result that causes you to exceed the operational evaluation level. The written report must be made available to the public upon request.

14.7.2.2 Your operational evaluation must include an examination of system treatment and distribution operational practices, including storage tank operations, excess storage capacity, distribution system flushing, changes in sources or source water quality, and treatment changes or problems that may contribute to TTHM and HAA5 formation and what steps could be considered to minimize future exceedances.

14.7.2.2.1 You may request and the Division may allow you to limit the scope of your evaluation if you are able to identify the cause of the operational evaluation level exceedance.

14.7.2.2.2 Your request to limit the scope of the evaluation does not extend the schedule in subsection 14.7.2.1 for submitting the written report. The Division must approve this limited scope of evaluation in writing and you must keep that approval with the completed report.

14.8 Requirements for remaining on reduced TTHM and HAA5 monitoring based on results under Section 12.0.

14.8.1 You may remain on reduced monitoring after the dates identified in subsection 14.1.3 for compliance with this section only if you qualify for a 40/30 certification under subsection 13.4 or have received a very small system waiver under subsection 13.5, plus you meet the reduced monitoring criteria in subsection 14.4.1, and you do not change or add monitoring locations from those used for compliance monitoring under Section 12.0 of this part. If your monitoring locations under this section differ from your monitoring locations under Section 12.0 of this part, you may not remain on reduced monitoring after the dates identified in subsection 14.1.3 for compliance with this section.

14.9 Requirements for remaining on increased TTHM and HAA5 monitoring based on results from Section 12.0.

14.9.1 If you were on increased monitoring under subsection 12.7.1, you must remain on increased monitoring until you qualify for a return to routine monitoring under subsection 14.6.3. You must conduct increased monitoring under subsection 14.6 at the monitoring locations in the monitoring plan developed under subsection 14.3 beginning at the date identified in subsection 14.1.3 for compliance with this section and remain on increased monitoring until you qualify for a return to routine monitoring under subsection 14.6.3.

14.10 Reporting and recordkeeping requirements.

14.10.1 Reporting.

14.10.1.1 You must report the following information for each monitoring location to the Division within 10 days of the end of any quarter in which monitoring is required:

14.10.1.1.1 Number of samples taken during the last quarter.

14.10.1.1.2 Date and results of each sample taken during the last quarter.

14.10.1.1.3 Arithmetic average of quarterly results for the last four quarters for each monitoring location (LRAA), beginning at the end of the fourth calendar quarter that follows the compliance date and at the end of each subsequent quarter. If the LRAA calculated based on fewer than four quarters of data would cause the MCL to be exceeded regardless of the monitoring results of subsequent quarters, you must report this information to the Division as part of the first report due following the compliance date or anytime thereafter that this determination is made. If you are required to conduct monitoring at a frequency that is less than quarterly, you must make compliance calculations beginning with the first compliance sample taken after the compliance date, unless you are required to conduct increased monitoring under subsection 14.6.

14.10.1.1.4 Whether, based on subsection 9.2.1.2 and this section, the MCL was violated at any monitoring location.

14.10.1.1.5 Any operational evaluation levels that were exceeded during the quarter and, if so, the location and date, and the calculated TTHM and HAA5 levels.

14.10.1.2 If you are a surface water or ground water under the direct influence of surface water system seeking to qualify for or remain on reduced TTHM/HAA5 monitoring, you must report the following source water TOC information for each treatment plant that treats surface water or ground water under the direct influence of surface water to the Division within 10 days of the end of any quarter in which monitoring is required:

14.10.1.2.1 The number of source water TOC samples taken each month during last quarter.

14.10.1.2.2 The date and result of each sample taken during last quarter.

14.10.1.2.3 The quarterly average of monthly samples taken during last quarter or the result of the quarterly sample.

14.10.1.2.4 The running annual average (RAA) of quarterly averages from the past four quarters.

14.10.1.2.5 Whether the RAA exceeded 4.0 mg/L.

14.10.1.3 The Division may choose to perform calculations and determine whether the MCL was exceeded or the system is eligible for reduced monitoring in lieu of having the system report that information

14.10.2 Recordkeeping. You must retain any Section 14.0 monitoring plans and your monitoring results under Section 14.0 as required by subsection 5.0.

**History**
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *25 DE Reg. 713 (01/01/22)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *5 DE Reg. 2121 (05/01/02)*
- *9 DE Reg. 999 (12/01/05)*
- *15 DE Reg. 73 (07/01/12)*
- *17 DE Reg. 439 (10/01/13)*
- *19 DE Reg. 517 (12/01/15)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *25 DE Reg. 713 (01/01/22)*

##### **16 Del. Admin. Code § 4462-15.0** Radioactivity {#sec-4462-15.0 omnilex-key=us-de-regs-official--title-16--4462-15.0}

15.1 Limits

15.1.1 Maximum Contaminant Levels for radionuclides:

15.1.1.1 Reserved

15.1.1.2 MCL for radium-226 and -228: The MCL for combined radium-226 and radium-228 is five (5) pCi/L. The combined radium-226 and radium-228 value is determined by the addition of the results of the analysis radium-226 and the analysis for radium-228.

15.1.1.3 MCL for gross alpha particle activity (excluding radon and uranium): The MCL for gross alpha particle activity (including radium-226 but excluding radon and uranium) is fifteen (15) pCi/L.

15.1.1.4 MCL for beta particle and photon radioactivity:

15.1.1.4.1 The average annual concentration of beta particle and photon radioactivity for man-made radionuclides in drinking water must not produce an annual dose equivalent to the total body or any internal organ greater than four (4) millirems per year.

15.1.1.4.2 Except for those listed in Table A below, the concentration of man-made radionuclides causing four (4) millirems total body or organ dose equivalents must be calculated on the basis of a two (2) liters per day drinking water intake using the 168 hour data listed in "Maximum Permissible Body Burdens and Maximum Permissible Concentration of Radionuclides in Air or Water for Occupational Exposure," NBS (National Bureau of Standards) Handbook 69 as amended August 1963, U.S. Department of Commerce.This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 522(a) and 1 CFR part 51. Copies of this document are available from the National Technical Information Service, NTIS ADA 280 282, U.S. Department of Commerce, 5285 Port Royal Road, Springfield, Virginia 22161. The toll-free number is 800-553-6847. Copies may be inspected at EPA’s Drinking Water Docket, 401 M Street, SW, Washington, DC 20460; or at the Office of the Federal Register, 800 North Capitol Street, NW, Suite 700, Washington, DC. If two (2) or more radionuclides are present, the sum of their annual dose equivalent to the total body or to any organ shall not exceed four (4) millirems per year.

Table A: Average Annual Concentrations Assumed to Produce a Total Body or Organ Dose of 4 Millirems/Year

15.1.1.5 MCL for uranium: The MCL for uranium is 30 ug/L.

15.1.1.6 Compliance dates:

15.1.1.6.1 Compliance dates for the combined radium-226 and -228, gross alpha particle activity, gross beta particle and photon radioactivity, and uranium: Community water systems must comply with the MCLs listed subsections 15.1.1.2, 15.1.1.3, 15.1.1.4, and 15.1.1.5 beginning December 8, 2003 and compliance shall be determined in accordance with the requirements of subsections 15.2.1 and 15.2.4. Compliance with reporting requirements for the radionuclides Section 4.0 is required on December 8, 2003.

15.1.1.6.2 Reserved

15.1.1.7 Best Available Technologies (BATs) for radionuclides: The Administrator of the U.S. Environmental Protection Agency, pursuant to section 1412 of the Safe Drinking Water Act, hereby identifies as indicated in the following table the best technology available for achieving compliance with the MCLs for combined radium-226 and -228, uranium, gross alpha particle activity, and beta particle and photon radioactivity.

Table B: BAT for Combined Radium-226 and Radium-228, Uranium, Gross Alpha Particle Activity, and Beta Particle and Photon Radioactivity

15.1.1.8 Small systems compliance technologies list for radionuclides.

Table C: List of Small Systems Compliance Technologies for Radionuclides and Limitations of Use

Table D: Compliance Technologies by System Size Category for Radionuclide National Primary Drinking Water Regulations (NPDWR’s)

15.2 Monitoring frequency and compliance requirements for radionuclides in community water systems.

15.2.1 Monitoring and compliance requirements for gross alpha particle activity, radium-226, radium-228, and uranium.

15.2.1.1 Community water systems (CWSs) must conduct initial monitoring to determine compliance with subsection 15.1 by December 31, 2007. For the purpose of monitoring for gross alpha particle activity, radium-226, radium-228, uranium, and beta particle and photon radioactivity in drinking water, “detection limit” is defined as in 40 CFR 141.25(c).

15.2.1.1.1 Applicability and sampling location for existing community water systems or sources. All existing CWSs using groundwater, surface water or systems using both ground and surface water (for the purpose of this section hereafter referred to as systems) must sample at every entry point to the distribution system that is representative of all sources being used (hereafter called a sample point) under normal operating conditions. The system must take each sample at the sampling point unless conditions make another sampling point more representative of each source or the Division has designated a distribution system location, in accordance with subsection 15.2.1.2.2.3.

15.2.1.1.2 Applicability and sampling location for new community water systems or sources. All CWSs or CWSs that use a new source of water must begin to conduct initial monitoring for the new source within the first quarter after initiating use of the source. CWSs must conduct more frequent monitoring when ordered by the Division in the event of possible contamination or when changes in the distribution system or treatment processes occur that may increase the concentration of radioactivity in finished water.

15.2.1.2 Initial monitoring: Systems must conduct initial monitoring for gross alpha particle activity, radium-226, radium-228, and uranium as follows:

15.2.1.2.1 Systems without acceptable historical data, as defined below, must collect four consecutive quarterly samples at all sampling points before December 31, 2007.

15.2.1.2.2 Grandfathering of data: The Division may allow historical monitoring data collected at a sampling point to satisfy the initial monitoring requirements for that sampling point, for the following situations.

15.2.1.2.2.1 To satisfy initial monitoring requirements, a community water system having only one entry point to the distribution system may use the monitoring data from the last compliance monitoring period that began between June 2000 and December 8, 2003.

15.2.1.2.2.2 To satisfy initial monitoring requirements, a community water system with multiple entry points and having appropriate historical monitoring data for each entry point to the distribution system may use the monitoring data from the last compliance monitoring period that began between June 2000 and December 8, 2003.

15.2.1.2.2.3 To satisfy initial monitoring requirements, a community water system with appropriate historical data for a representative point in the distribution system may use the monitoring data from the last compliance monitoring period that began between June 2000 and December 8, 2003, provided that the Division finds that the historical data satisfactorily demonstrate that each entry point to the distribution system is expected to be in compliance based upon the historical data and reasonable assumptions about the variability of contaminant levels between entry points. The Division must make a written finding indicating how the data conforms to these requirements.

15.2.1.2.3 For gross alpha particle activity, uranium, radium-226, and radium-228 monitoring, the Division may waive the final two quarters of initial monitoring for a sampling point if the results of the samples from the previous two quarters are below the detection limit.

15.2.1.2.4 If the average of the initial monitoring results for a sampling point is above the MCL, the system must collect and analyze quarterly samples at that sampling point until the system has results from four consecutive quarters that are at or below the MCL, unless the system enters into another schedule as part of a formal compliance agreement with the Division.

15.2.1.3 Reduced monitoring: The Division may allow CWSs to reduce the future frequency of monitoring from once every three years to once every six or nine years at each sampling point, based on the following criteria.

15.2.1.3.1 If the average of the initial monitoring results for each contaminant (i.e., gross alpha particle activity, uranium, radium-226, or radium-228) is below the detection limit specified in subsection 15.2.4.3.1 Table A, the system must collect and analyze for that contaminant using at least one sample at that sampling point every nine years.

15.2.1.3.2 For gross alpha particle activity and uranium, if the average of the initial monitoring results for each contaminant is at or above the detection limit but at or below ½ the MCL, the system must collect and analyze for that contaminant using at least one sample at that sampling point every six years. For combined radium-226 and radium-228, the analytical results must be combined. If the average of the combined initial monitoring results for radium-226 and radium-228 is at or above the detection limit but at or below ½ the MCL, the system must collect and analyze for that contaminant using at least one sample at that sampling point every six years.

15.2.1.3.3 For gross alpha particle activity and uranium, if the average of the initial monitoring results for each contaminant is above ½ the MCL but at or below the MCL, the system must collect and analyze at least one sample at that sampling point every three years. For combined radium-226 and radium-228, the analytical results must be combined. If the average of the combined initial monitoring results for radium-226 and radium-228 is above ½ the MCL but at or below the MCL, the system must collect and analyze at least one sample at that sampling point every three years.

15.2.1.3.4 Systems must use the samples collected during the reduced monitoring period to determine the monitoring frequency for subsequent monitoring periods (e.g., if a system’s sampling point is on a nine year monitoring period, and the sample result is above ½ the MCL, then the next monitoring period for that sampling point is three years).

15.2.1.3.5 If a system has a monitoring result that exceeds the MCL while on reduced monitoring, the system must collect and analyze quarterly samples at that sampling point until the system has results from four consecutive quarters that are below the MCL, unless the system enters into another schedule as part of a formal compliance agreement with the Division.

15.2.1.4 Compositing: To fulfill quarterly monitoring requirements for gross alpha particle activity, radium-226, radium-228, or uranium, a system may composite up to four consecutive quarterly samples from a single entry point if analysis is done within a year of the first sample. The Division will treat analytical results from the composited as the average analytical result to determine compliance with the MCLs and the future monitoring frequency. If the analytical result from the composited sample is greater than ½ the MCL, the Division may direct the system to take additional quarterly samples before allowing the system to sample under a reduced monitoring schedule.

15.2.1.5 A gross alpha particle activity measurement may be substituted for the required radium-226 measurement provided that the measured gross alpha particle activity does not exceed 5 pCi/L. A gross alpha particle activity measurement may be substituted for the required uranium measurement provided that the measured gross alpha particle activity does not exceed 15 pCi/L. The gross alpha measurement shall have a confidence interval of 95% (1.65s, where s is the standard deviation of the net counting rate of the sample) for radium-226 and uranium. When a system uses a gross alpha particle activity measurement in lieu of radium-226 and/or uranium measurement, the gross alpha particle activity analytical result will be used to determine the future monitoring frequency for radium-226 and/or uranium. If the gross alpha particle activity result is less than detection, ½ the detection limit will be used to determine compliance and the future monitoring frequency.

15.2.2 Monitoring and compliance requirements for beta particle and photon radioactivity. To determine compliance with the maximum contaminant levels in subsection 15.1.1.4 for beta particle and photon radioactivity, a system must monitor at a frequency as follows.

15.2.2.1 Community water systems (both surface and ground water) designated by the Division as vulnerable must sample for beta particle and photon radioactivity. Systems must collect quarterly samples for beta emitters and annual samples for tritium and strontium-90 at each entry point to the distribution system (hereafter called a sampling point), beginning within one quarter after being notified by the Division. Systems already designated by the Division must continue to sample until the Division reviews and either reaffirms or removes the designation.

15.2.2.1.1 If the gross beta particle activity minus the naturally occurring potassium-40 beta particle activity at a sampling point has a running annual average (computed quarterly) less than or equal to 50 pCi/L (screening level), the Division may reduce the frequency of monitoring at that sampling point to once every three years. Systems must collect all samples required in subsection 15.2.2.1 during the reduced monitoring period.

15.2.2.1.2 For systems in the vicinity of a nuclear facility, the Division may allow the CWS to utilize environmental surveillance data collected by the nuclear facility in lieu of monitoring at the system’s entry point(s), where the Division determines if such data is applicable to a particular water system. In the event that there is a release from a nuclear facility, systems that are using surveillance data must begin monitoring at the community water system’s entry point(s) in accordance with subsection 15.2.2.1.

15.2.2.2 Community water systems (both surface and ground water) designated by the Division as utilizing waters contaminated by effluents from nuclear facilities must sample for beta particle and photon radioactivity. Systems must collect quarterly samples for beta emitters and iodine-131 and annual samples for tritium and strontium-90 at each entry point to the distribution system (hereafter called a sampling point), beginning within one quarter after being notified by the Division. Systems already designated by the Division as systems using waters contaminated by effluents from nuclear facilities must continue to sample until the Division reviews and either reaffirms or removes the designation.

15.2.2.2.1 Quarterly monitoring for gross beta particle activity shall be based on the analysis of monthly samples or the analysis of a composite of three monthly samples. The former is recommended.

15.2.2.2.2 For iodine-131, a composite of five consecutive daily samples shall be analyzed once each quarter. As ordered by the Division, more frequent monitoring shall be conducted when iodine-131 is identified in the finished water.

15.2.2.2.3 Annual monitoring for strontium-90 and tritium shall be conducted by means of a composite of four consecutive quarterly samples or analysis of four quarterly samples. The latter procedure is recommended.

15.2.2.2.4 If the gross beta particle activity beta minus the naturally occurring potassium-40 beta particle at a sampling point has a running annual average (computed quarterly) less than or equal to 15 pCi/L, the Division may reduce the frequency of monitoring at that sampling point to every three years. Systems must collect all samples required in subsection 15.2.2.1 during the reduced monitoring period.

15.2.2.2.5 For systems in the vicinity of a nuclear facility, the Division may allow the CWS to utilize environmental surveillance data collected by the nuclear facility in lieu of monitoring at the system’s entry point(s), where the Division determines if such data is applicable to a particular water system. In the event that there is a release from a nuclear facility, systems that are using surveillance data must begin monitoring at the community water system’s entry point(s) in accordance with subsection 15.2.2.2.

15.2.2.3 Community water systems designated by the Division to monitor for beta particle and photon radioactivity cannot apply to the Division for a waiver from the monitoring frequencies specified in subsections 15.2.2.1 or 15.2.2.2.

15.2.2.4 Community water systems may analyze for naturally occurring potassium-40 beta particle activity from the same or equivalent sample used for the gross beta particle activity analysis. Systems are allowed to subtract the potassium-40 beta particle activity value from the total gross beta particle activity value to determine if the screening level is exceeded. The potassium-40 beta particle activity must be calculated by multiplying elemental potassium concentrations (in mg/L) by a factor of 0.82.

15.2.2.5 If the gross beta particle activity minus the naturally occurring potassium-40 beta particle activity exceeds the appropriate screening level, an analysis of the sample must be performed to identify the major radioactive constituents present in the sample and the appropriate doses must be calculated and summed to determine compliance with subsection 15.1.1, using the formula in subsection 15.1.1.4.2. Doses must also be calculated and combined for measured levels of tritium and strontium to determine compliance.

15.2.2.6 Systems must monitor monthly at the sampling point(s) that exceed the MCL in subsection 15.1.1 beginning the month after the exceedance occurs. Systems must continue monthly monitoring until the system has established, by a rolling average of three monthly samples, that the MCL is being met. Systems who establish that the MCL is being met must return to quarterly monitoring until they meet the requirements set forth in subsections 15.2.2.1.2 or 15.2.2.2.1.

15.2.3 General monitoring and compliance requirements for radionuclides.

15.2.3.1 The Division may require more frequent monitoring than specified in subsections 15.2.1 and 15.2.2, or may require confirmation samples at its discretion. The results of the initial and confirmation samples will be averaged for use in compliance determinations.

15.2.3.2 Each public water system shall monitor at the time designated by the Division during each compliance period.

15.2.3.3 Compliance: Compliance with subsection 15.1.1 will be determined based on the analytical result(s) obtained at each sampling point. If one sampling point is in violation of an MCL, the system is in violation of the MCL.

15.2.3.3.1 For systems monitoring more than once per year, compliance with the MCL is determined by a running annual average at each sampling point. If the average of any sampling point is greater than the MCL, then the system is out of compliance with the MCL.

15.2.3.3.2 For systems monitoring more than once per year, if any sample result will cause the running annual average to exceed the MCL at any sample point, the system is out of compliance with the MCL immediately.

15.2.3.3.3 Systems must include all samples taken and analyzed under the provisions of this section in determining compliance, even if that number is greater than the minimum required.

15.2.3.3.4 If a system does not collect all required samples when compliance is based on a running annual average of quarterly samples, compliance will be based on the running average of the samples collected.

15.2.3.3.5 If a sample result is less than the detection limit, zero will be used to calculate the annual average, unless a gross alpha particle activity is being used in lieu of radium-226 and/or uranium. If the gross alpha particle activity result is less than detection, ½ the detection limit will be used to calculate the annual average.

15.2.3.4 The Division has the discretion to delete results of obvious sampling or analytical errors.

15.2.3.5 If the MCL for radioactivity set forth in subsection 15.1.1 is exceeded, the operator of a community water system must give notice to the Division pursuant to subsection 4.1.2 and to the public as required in subsection 4.2.

15.2.4 Analytical Methodology:

15.2.4.1 The methods specified in 40 CFR 141.25(a), copies may be obtained from the Office of Drinking Water, are to be used to determine compliance with Section 15.0.

15.2.4.2 When the identification and measurement of radionuclides other than those listed in subsection 15.2.4.1 is required, the following references are to be used, except in cases where alternative methods have been approved in accordance with 40 CFR 141.27.

15.2.4.2.1 Procedures for Radiochemical Analysis of Nuclear Reactor Aqueous Solutions, H. L. Krieger and S. Gold, EPA-R4-73-014. USEPA, Cincinnati, Ohio, May 1973

15.2.4.2.2 HASL Procedure Manual, Edited by John H. Harley. HASL 300, ERDA Health and Safety Laboratory, New York, NY. 1973

15.2.4.3 For the purpose of monitoring radioactivity concentrations in drinking water, the required sensitivity of the radioanalysis is defined in terms of a detection limit. The detection limit shall be that concentration which can be counted with a precision of plus or minus one hundred (100) percent at the ninety-five (95) percent confidence level (1.96σ where σ is the standard deviation of the net counting rate of the sample).

15.2.4.3.1 To determine compliance with subsections 15.1.1.2, 15.1.1.3, and 15.1.1.5 the detection limit shall not exceed the concentrations in Table A to this paragraph.

Table A. – Detection Limits for Gross Alpha Particle Activity, Radium 226, Radium 228, and Uranium

15.2.4.3.2 To determine compliance with subsection 15.1.1.4 the detection limits shall not exceed the concentrations listed in Table B to this paragraph.

Table B. – Detection Limits for Man-Made Beta Particle and Photon Emitters

15.2.4.4 To judge compliance with the maximum contaminant levels listed in subsections 15.1.1.2 and 15.1.1.4 averages of the data shall be used and shall be rounded to the same number of significant figures as the maximum contaminant level for the substance in question.

15.2.4.5 The Division has the authority to determine compliance or initiate enforcement action based on analytical results or other information compiled by sanctioned representatives and agencies.

15.2.5 Monitoring of consecutive public water systems. When a public water system supplies water to one or more other public water systems, the division may modify the monitoring requirements imposed by this part to the extent that the interconnection of the systems justifies treating them as a single system for monitoring purposes. Any modified monitoring shall be conducted pursuant to a schedule specified by the Division and concurred in by the Administrator of the U.S. Environmental Protection Agency.

**History**
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *25 DE Reg. 713 (01/01/22)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *5 DE Reg. 2121 (05/01/02)*
- *9 DE Reg. 999 (12/01/05)*
- *15 DE Reg. 73 (07/01/12)*
- *17 DE Reg. 439 (10/01/13)*
- *19 DE Reg. 517 (12/01/15)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *25 DE Reg. 713 (01/01/22)*

##### **16 Del. Admin. Code § 4462-16.0** Surface Water Treatment Rule {#sec-4462-16.0 omnilex-key=us-de-regs-official--title-16--4462-16.0}

16.1 Untreated Water: The use of untreated (without filtration and disinfection) surface water or untreated ground water under the direct influence of surface water shall be prohibited.

16.2 General Requirements: Each public water system with a surface water source or a ground water source under the direct influence of surface water must be operated by qualified personnel who meet the requirements of the Division and must provide treatment of that source water that complies with these treatment technique requirements. The treatment technique requirements consist of installing and properly operating water treatment processes which reliably achieve:

16.2.1 At least 99.9 percent (3-log) removal and/or inactivation of Giardia lamblia cysts between a point where the raw water is not subject to recontamination by surface water runoff and a point downstream before or at the first customer; and

16.2.2 At least 99.99 percent (4-log) removal and/or inactivation of viruses between a point where the raw water is not subject to recontamination by surface water runoff and a point downstream before or at the first customer.

16.2.3 In addition to complying with the requirements in this section, systems serving fewer than 10,000 people must also comply with the requirements in subsection 16.13.

16.3 Disinfection: Each public water system with a surface water source or a ground water source under the direct influence of surface water must provide treatment consisting of both filtration as specified in subsection 16.4 and disinfection as follows:

16.3.1 The disinfection treatment must be sufficient to ensure that the total treatment processes of that system achieve at least 99.9 percent (3-log) inactivation and/or removal of Giardia lamblia cysts and at least 99.99 percent (4-log) inactivation and/or removal of viruses, as determined by the Division.

16.3.2 The residual disinfectant concentration in the water entering the distribution system, measured as specified in subsection 16.5 cannot be less than 0.3 mg/L for more than four (4) hours.

16.3.3 The residual disinfectant concentration in the distribution system, measured as total chlorine, combined chlorine, or chlorine dioxide, as specified in subsection 16.5 cannot be undetectable, a chlorine residual of <0.04 mg/L is deemed to be undetectable, in more than five (5) percent of the samples each month, for any two (2) consecutive months that the system serves water to the public. Water in the distribution system with a heterotrophic bacteria concentration less than or equal to five hundred (500) per milliliter, measured as heterotrophic plate count (HPC) as specified in subsection 16.6, is deemed to have a detectable disinfectant residual for purposes of determining compliance with this requirement. Thus, the value V in the following formula cannot exceed five (5) percent in one (1) month, for any two (2) consecutive months.

V = c + d + e X 100

a + b

where:

a = number of instances where the residual disinfectant concentration is measured;

b = number of instances where the residual disinfectant concentration is not measured but HPC is measured;

c = number of instances where the residual disinfectant concentration is measured but not detected and no HPC is measured;

d = number of instances where no residual disinfectant concentration is detected and where the HPC is >500/ml; and

e = number of instances where the residual disinfectant concentration is not measured and HPC is >500/ml.

If the Division determines, based on site specific considerations, that a system has no means for having a sample transported and analyzed for HPC by an approved laboratory under the requisite time and temperature conditions specified in subsection 16.6, and that the system is providing adequate disinfection in the distribution system, the requirements of this Section do not apply.

16.4 Filtration: Each public water system with a surface water source or a ground water source under the direct influence of surface water must provide treatment consisting of both disinfection as specified in subsection 16.3 and filtration that complies with any one (1) of the following by June 29, 1993:

16.4.1 Conventional Filtration or Direct Filtration - For systems using conventional filtration or direct filtration, the turbidity level of representative samples of a system's filtered must be less than or equal to 0.5 NTU in at least ninety-five (95) percent of the measurements taken each month, measured as specified in subsection 16.6, except that if the Division determines that the system is capable of achieving at least 99.9 percent removal and/or inactivation of Giardia lamblia cysts at some turbidity level higher than 0.5 NTU in at least ninety-five (95) percent of the measurements taken each month, the Division may substitute this higher turbidity limit for that system. However, in no case may the Division approve a turbidity limit that allows more than one (1) NTU in more than five (5) percent of the samples taken each month, measured as specified in subsection 16.6. The turbidity level of representative samples of a system's filtered water must at no time exceed five (5) NTU, measured as specified in subsection 16.6.

16.4.2 Slow Sand Filtration - For systems using slow sand filtration, the turbidity level of representative samples of a system's filtered water must be less than or equal to one (1) NTU in at least ninety-five (95) percent of the measurements taken each month, measured as specified in subsection 16.6, except that if the Division determines there is no significant interference with disinfection at a higher turbidity level, the Division may substitute the higher turbidity limit for that system.

16.4.3 Diatomaceous Earth Filtration - For systems using diatomaceous earth filtration, the turbidity level of representative samples of a system's filtered water must be less than or equal to one (1) NTU in at least ninety-five (95) percent of the measurements taken each month, measured as specified in subsection 16.6. The turbidity level of representative samples of a system's filtered water must at no time exceed five (5) NTU, measured as specified in subsection 16.6.

16.4.4 Other Filtration Technologies - A public water system may use a filtration technology not listed in this section if it demonstrates to the Division, using pilot plant studies or other means, that the alternative filtration technology, in combination with disinfection treatment that meets the requirements of subsection 16.3, consistently achieves 99.9 percent removal and/or inactivation of Giardia lamblia cysts and 99.99 percent removal and/or inactivation of viruses. For a system that makes this demonstration, the requirements of subsection 16.4.2 apply. Beginning January 1, 2002 systems serving at least 10,000 people must meet the requirements for other filtration technologies in subsection 16.9.2. Beginning January 1, 2005 systems serving fewer than 10,000 people must meet the requirements for other filtration technologies in 40 CFR subpart T. Copies are available from the Office of Drinking Water.

16.4.5 Beginning January 1, 2005 systems serving fewer than 10,000 people must meet the turbidity requirements in 40 CFR subpart T. Copies are available from the Office of Drinking Water.

16.5 Monitoring Requirements: - A public water system that uses a surface water source or a ground water source under the direct influence of surface water must monitor in accordance with the following by June 29, 1993:

16.5.1 Turbidity measurements as required by subsection 16.4 must be performed on representative samples of the system's filtered water at least every four (4) hours that the system serves water to the public. A public water system may substitute continuous turbidity monitoring for grab sample monitoring if it validates the continuous measurement for accuracy on a regular basis using a protocol approved by the Division. For any systems using slow sand filtration or filtration treatment other than conventional treatment, direct filtration or diatomaceous earth filtration, the Division may reduce the sampling frequency to once per day if it determines that less frequent monitoring is sufficient to indicate effective filtration performance. For systems serving five hundred (500) or fewer persons, the Division may reduce the turbidity sampling frequency to once per day, regardless of the type of filtration treatment used, if the Division determines that less frequent monitoring is sufficient to indicate effective filtration performance.

16.5.2 The residual disinfectant concentration of the water entering the distribution system must be monitored continuously, and the lowest value must be recorded each day, except that if there is a failure in the continuous monitoring equipment, grab sampling every four (4) hours may be conducted in lieu of continuous monitoring, but for no more than five (5) working days following the failure of the equipment, and systems serving 3,300 or fewer persons may take grab samples in lieu of providing continuous monitoring on an ongoing basis at the frequencies each day prescribed below:

*The day's samples cannot be taken at the same time. The sampling intervals are subject to Division review and approval.

If at any time the residual disinfectant concentration falls below 0.3 mg/L in a system using grab sampling in lieu of continuous monitoring, the system must take a grab sample every four (4) hours until the residual disinfectant concentration is equal to or greater than 0.3 mg/L.

16.5.3 Until December 31, 2015 the residual disinfectant concentration must be measured at least at the same points in the distribution system and at the same time as total coliforms are sampled, as specified in Section 7.0. Beginning January 1, 2016, the residual disinfectant concentration must be measured at least at the same points in the distribution system and at the same time as total coliforms are sampled, as specified in subsections 7.4.4 through 7.4.8. The Division may allow a public water system which uses both a surface water source or a ground water source under the direct influence of surface water, and a ground water source to take disinfectant residual samples at points other than the total coliform sampling points if the Division determines that such points are more representative of treated (disinfected) water quality within the distribution system. Heterotrophic bacteria, measured as HPC as specified in subsection 16.6, may be measured in lieu of residual disinfectant concentration. If the Division determines, based on site specific considerations, that a system has no means for having a sample transported and analyzed for HPC by an approved laboratory under the requisite time and temperature conditions specified in subsection 16.6 and that the system is providing adequate disinfection in the distribution system, the requirements of this Section do not apply.

16.6 Analytical Methodology - Only the analytical method(s) specified in this section, or otherwise approved by EPA, may be used to demonstrate compliance with subsections 16.2, 16.3 and 16.4. Measurement for pH, temperature, turbidity and residual disinfectant concentration must be conducted by a party approved by the Division. Measurements for total coliforms, fecal coliforms and HPC must be conducted by an approved laboratory. Until laboratory approval criteria are developed for the analysis of HPC and fecal coliforms, any laboratory approved for total coliform analysis is deemed approved for HPC and fecal coliform analysis. The following procedures shall be performed in accordance with the publications listed in the following section. This incorporation by reference was approved by the Director of the Federal register in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. Copies of the methods published in Standard Methods published in Standard Methods for the Examination of Water and Wastewater may be obtained from the American Public Health Association et al. 1015 Fifteenth Street, NW., Washington, D.C. 20005; copies of the Minimal Medium ONPG-MUG Method as set forth in the article "National Field Evaluation of a Defined Substrate Method for the Simultaneous Enumeration of Total Coliforms and Escherichia coli from Drinking Water: Comparison with the Standard Multiple Tube Fermentation Method" (Edberg et al), Applied and Environmental Microbiology, Volume 54, pp.1595-1601, June 1988 (as amended under Erratum, Applied and Environmental Microbiology, Volume 54, p. 3197, December 1988), may be obtained from the American Water Works Association Research Foundation, 6666 West Quincy Ave., Denver, Colorado 80235; and copies of the Indigo Method as set forth in the article "Determination of Ozone in Water by the Indigo Method" (Bader and Hoigne), may be obtained from Ozone Science and Engineering, Pergammon Press Ltd., Fairview Park, Elmsford, New York 10523. Copies may be inspected at the U.S.E.P.A., Room EB15, 401 M Street SW., Washington, D.C. 20460 or at the Office of the Federal register, 1100 L Street, NW., Room 8401, Washington, D.C.

16.6.1 Total Coliform Concentration - See subsection 7.2.

16.6.2 Fecal Coliform Concentration - See subsection 7.2

16.6.3 Heterotrophic Plate Count - Method 907A (Pour Plate Method), pp. 864-866, as set forth in Standard Methods for the Examination of water and Wastewater, 1986, American Public Health Association et al., 16th edition.

16.6.4 Turbidity - See section 17.4, 40 CFR 141.74(a)(1)

16.6.5 Residual Disinfectant Concentration - Residual disinfectant concentrations for free chlorine and combined chlorine (chloramines) must be measured by Method 408C (Amperometric Titration Method), pp. 303-306, Method 408D (DPD Ferrous Titrametric Method), pp. 306-309, Method 408E (DPD Colorimetric Method), pp. 309-310, or Method 408F (Leuco Crystal Violet Method), pp. 310-313, as set forth in Standard Methods for the Examination of Water and Wastewater, 1985, American Public Health Association et al., 16th edition. Residual disinfectant concentrations for free chlorine and combined chlorine may also be measured by using DPD colorimetric test kits if approved by the Division. Residual disinfectant concentration for ozone must be measured by the Indigo Method as set forth in Bader, H., Hoigne, J., "Determination of Ozone in Water by the Indigo Method; A submitted Standard Method"; Ozone Science and Engineering, Vol. 4 pp. 169-176, Pergammon Press Ltd., 1982, or automated methods which are calibrated in reference to the results obtained by the Indigo Method on a regular basis, if approved by the Division (NOTE - This method will be published in the 17th edition of Standard Methods for the Examination of Water and Wastewater, 1985, American Public Health Association et al., the Iodometric Method in the 16th edition may not be used). Residual disinfectant concentrations for chlorine dioxide must be measured by Method 410B (Amperometric Method) or Method 410C (DPD Method), pp. 322-324, as set forth in Standard Methods for the Examination of Water and Wastewater, 1985, American Public Health Association et al., 16th edition.

16.6.6 Temperature - Method 212 (Temperature), pp. 126-127, as set forth in Standard Methods for the Examination of Water and Wastewater, 1985, American Public Health Association et al., 16th edition.

16.6.7 pH - Method 423 (pH Value), pp. 429-437, as set forth in Standard Methods for the Examination of Water and Wastewater, 1985, American Public Health Association et al., 16th edition.

16.6.7.1 "Methods of Chemical analysis of Water and Wastes," EPA Environmental Monitoring and Support Laboratory, Cincinnati, Ohio 45268 (EPA-600/4-79-020), March 1985. Available from ORD Publications, CERI, EPA, Cincinnati, Ohio 45268

16.6.7.2 Annual Book of ASTM Standards, Volume 11.01, American Society for Testing and Materials, 1916 Race Street, Philadelphia, PA 19013.

16.6.7.3 "Standard Methods for the Examination of Water and Wastewater," 16th Edition, American Public Health Association, American Water Works Association, Water Pollution Control Federation, 1985.

16.6.7.4 "Methods for Determination of Inorganic Substances in Water and Fluvial Sediments," Techniques of Water-Resources Investigations of the United States Geological Survey Books, Chapter A1, 1985, Open-File Report 85-495. Available from Open-File Services section, Western Distribution Branch, U.S. Geological Survey, MS 306 Box 24525, Denver Federal Center, Denver, Colorado 80225.

16.6.7.5 "Fluoride in Water and Wastewater. Industrial Method #129-71 W." Technicon Industrial Systems. Tarrytown, New York 10591, December 1972.

16.6.7.6 "Fluoride in Water and Wastewater," Technicon Industrial Systems. Tarrytown, New York 10591, February 1976.

16.6.7.7 "Orion Guide to Water and Wastewater Analysis." Form WeEEG/5880, p. 5, 1985. Orion Research, Inc., Cambridge, Maryland.

16.6.7.8 "Inductively Coupled Plasma Atomic Emission Analysis of Drinking Water," Appendix to Method 200.7, September 1985. U.S.E.P.A. Environmental Monitoring and Support Laboratory, Cincinnati, Ohio 45268.

16.6.7.9 The addition of 1 ml of 30% of H2O2 to each 100 ml of standards and samples is required before analysis.

16.6.7.10 Prior to dilution of the Arsenic and Selenium calibration standards, add 2 ml of 30% H2O2 for each 100 ml of standard.

16.6.7.11 For approved analytical procedures for metals, the technique applicable to total metals must be used.

**History**
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *25 DE Reg. 713 (01/01/22)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *5 DE Reg. 2121 (05/01/02)*
- *9 DE Reg. 999 (12/01/05)*
- *15 DE Reg. 73 (07/01/12)*
- *17 DE Reg. 439 (10/01/13)*
- *19 DE Reg. 517 (12/01/15)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *25 DE Reg. 713 (01/01/22)*

##### **16 Del. Admin. Code § 4462-17.0** Interim Enhanced Surface Water Treatment Rule {#sec-4462-17.0 omnilex-key=us-de-regs-official--title-16--4462-17.0}

17.1 The requirements of this section constitute national primary drinking water regulations. These regulations establish requirements for filtration and disinfection that are in addition to criteria under which filtration and disinfection are required by surface water or ground water under the direct influence of surface water systems. The requirements of this section are applicable to surface water or ground water under the direct influence of surface water systems serving at least 10,000 people, beginning December 17, 2001 unless otherwise specified in this section. The regulations in this section establish or extend treatment technique requirements in lieu of maximum contaminant levels for the following contaminants: Giardia lamblia, viruses, heterotrophic plate count bacteria, Legionella, Cryptosporidium, and turbidity. Each surface water or ground water under the direct influence of surface water system serving at least 10,000 people must provide treatment of its source water that complies with these treatment technique requirements and are in addition to those identified in subsection 16.2. The treatment technique requirements consist of installing and properly operating water treatment processes which reliably achieve:

17.1.1 At least 99 percent (2-log) removal of Cryptosporidium between a point where the raw water is not subject to recontamination by surface water runoff and a point downstream before or at the first customer for filtered systems, or Cryptosporidium control under the watershed control plan for unfiltered systems.

17.1.2 Compliance with the profiling and benchmark requirements under the provisions of subsection 17.5.

17.2 A public water system subject to the requirements of this section is considered to be in compliance with the requirements of subsection 17.1 if:

17.2.1 It meets the applicable filtration requirements in either subsections 16.4 or 17.9 and the disinfection requirements in subsections 16.3 and 17.5.

17.3 Systems are not permitted to begin construction of uncovered finished water storage facilities beginning February 16, 1999.

17.4 Surface water or ground water under the direct influence of surface water systems that did not conduct optional monitoring under subsection 17.5 because they served fewer than 10,000 people when such monitoring was required, but serve more than 10,000 people prior to January 1, 2005 must comply with subsections 16.1, 17.5, 17.6, 17.7 and 17.8. These systems must also consult with the Division to establish a disinfection benchmark. A system that decides to make a significant change to its disinfection practice, as described in subsections 17.5.3.1.1 through 17.5.3.1.4 must consult with the Division prior to making such change.

17.5 Disinfection Profiling and Benchmarking.

17.5.1 Determination of systems required to profile. A public water system subject to the requirements of this section must determine its TTHM annual average using the procedure in subsection 17.5.1.1 and its HAA5 annual average using the procedure in subsection 17.5.1.2. The annual average is the arithmetic average of the quarterly averages of four consecutive quarters of monitoring.

17.5.1.1 The TTHM annual average must be the annual average during the same period as is used for the HAA5 annual average.

17.5.1.1.1 Those systems that collected data under the provisions of 61 FR 24368, May 14, 1996 must use the results of the samples collected during the last four quarters of required monitoring under the Information Collection Rule.

17.5.1.1.2 Those systems that use “grandfathered” HAA5 occurrence data that meet the provisions of subsection 17.5.1.2.2 must use TTHM data collected at the same time under the provisions of 40 CFR 141.12 and 141.30. Copies may be obtained from the Office of Drinking Water.

17.5.1.1.3 Those systems that use HAA5 occurrence data that meet the provisions of subsection 17.5.1.2.3.1 must use TTHM data collected at the same time under the provisions of 40 CFR 141.12 and 141.30. Copies may be obtained from the Office of Drinking Water.

17.5.1.2 The HAA5 annual average must be the annual average during the same period as is used for the TTHM annual average.

17.5.1.2.1 Those systems that collected data under the provisions of 61 FR 24368, May 14, 1996 must use the results of the samples collected during the last four quarters of required monitoring under the Information Collection Rule.

17.5.1.2.2 Those systems that have collected four quarters of HAA5 occurrence data that meets the routine monitoring sample number and location requirements for TTHM in 40 CFR 141.12 and 141.30 and handling and analytical method requirements of the Information Collection Rule may use those data to determine whether the requirements of this section apply. Copies may be obtained from the Office of Drinking Water.

17.5.1.2.3 Those systems that have not collected four quarters of HAA5 occurrence data that meets the provisions of either subsections 17.5.1.2.1 or 17.5.1.2.2 by March 16, 1999 must either:

17.5.1.2.3.1 Conduct monitoring for HAA5 that meets the routine monitoring sample number and location requirements for TTHM in 40 CFR 141.12 and 141.30 and handling and analytical method requirements of 61 FR 24368, May 14, 1996. Copies may be obtained from the Office of Drinking Water, to determine the HAA5 annual average and whether the requirements of section 17.5.2 apply. This monitoring must be completed so that the applicability determination can be made no later than March 16, 2000, or

17.5.1.2.3.2 Comply with all other provisions of this section as if the HAA5 monitoring had been conducted and the results required compliance with subsection 17.5.2.

17.5.1.3 The system may request that the Division approve a more representative annual data set than the data set determined under subsections 17.5.1.1 or 17.5.1.2 for the purpose of determining applicability of the requirements of this section.

17.5.1.4 The Division may require that a system use a more representative annual data set than the data set determined under subsections 17.5.1.1 or 17.5.1.2 for the purpose of determining applicability of the requirements of this section.

17.5.1.5 The system must submit data to the Division on the schedule in subsections 17.5.1.5.1 through 17.5.1.5.5.

17.5.1.5.1 Those systems that collected TTHM and HAA5 data under the provisions of 61 FR 2436, May 14, 1996, as required by subsections 17.5.1.1.1 and 17.5.1.2.1, must submit the results of the samples collected during the last 12 months of required monitoring under 61 FR 2436, May 14, 1996 not later than December 16, 1999. Copies may be obtained from the Office of Drinking Water.

17.5.1.5.2 Those systems that have collected four consecutive quarters of HAA5 occurrence data that meets the routine monitoring sample number and location for TTHM in 40 CFR 141.12 and 141.30 and handling and analytical method requirements 61 FR 2436, May 14, 1996, copies may be obtained from the Office of Drinking Water, as allowed by subsections 17.5.1.1.2 and 17.5.1.2.2, must submit those data to the Division not later than April 16, 1999. Until the Division has approved the data, the system must conduct monitoring for HAA5 using the monitoring requirements specified under subsection 17.5.1.2.3

17.5.1.5.3 Those systems that conduct monitoring for HAA5 using the monitoring requirements specified by subsections 17.5.1.1.3 and 17.5.1.2.3.1, must submit TTHM and HAA5 data not later than March 16, 2000.

17.5.1.5.4 Those systems that elect to comply with all other provisions of this section as if the HAA5 monitoring had been conducted and the results required compliance with this section, as allowed under subsection 17.5.1.2.3.2, must notify the Division in writing of their election not later than December 16, 1999.

17.5.1.5.5 If the system elects to request that the Division approve a more representative annual data set than the data set determined under subsection 17.5.1.2.1, the system must submit this request in writing not later than December 16, 1999.

17.5.1.6 Any system having either a TTHM annual average >0.064 mg/L or an HAA5 annual average >0.048 mg/L during the period identified in subsections 17.5.1.1 and 17.5.1.2 must comply with subsection 17.5.2.

17.5.2 Disinfection profiling.

17.5.2.1 Any system that meets the criteria in subsection 17.5.1.6 must develop a disinfection profile of its disinfection practice for a period of up to three years.

17.5.2.2 The system must monitor daily for a period of 12 consecutive calendar months to determine the total logs of inactivation for each day of operation, based on the CT99.9 values in Tables 1.1-1.6, 2.1, and 3.1 of 40 CFR 141.74(b), as appropriate, through the entire treatment plant. This system must begin this monitoring not later than March 16, 2000. As a minimum, the system with a single point of disinfectant application prior to entrance to the distribution system must conduct the monitoring in subsections 17.5.2.2.1 through 17.5.2.2.4. A system with more than one point of disinfectant application must conduct the monitoring in subsections 17.5.2.2.1 through 17.5.2.2.4 for each disinfection segment. The system must monitor the parameters necessary to determine the total inactivation ratio, using analytical methods in 40 CFR 141.74(a), copies may be obtained from the Office of Drinking Water, as follows:

17.5.2.2.1 The temperature of the disinfected water must be measured once per day at each residual disinfectant concentration sampling point during peak hourly flow.

17.5.2.2.2 If the system uses chlorine, the pH of the disinfected water must be measured once per day at each chlorine residual disinfectant concentration sampling point during peak hourly flow.

17.5.2.2.3 The disinfectant contact time(s) (“T”) must be determined for each day during peak hourly flow.

17.5.2.2.4 The residual disinfectant concentration(s) (“C”) of the water before or at the first customer and prior to each additional point of disinfection must be measured each day during peak hourly flow.

17.5.2.3 In lieu of the monitoring conducted under the provisions of subsection 17.5.2.2 to develop the disinfection profile, the system may elect to meet the requirements of subsection 17.5.2.3.1. In addition to the monitoring conducted under the provisions of subsection 17.5.2.2 to develop the disinfection profile, the system may elect to meet the requirements of subsection 17.5.2.3.2.

17.5.2.3.1 A PWS that has three years of existing operational data may submit those data, a profile generated using those data, and a request that the Division approve use of those data in lieu of monitoring under the provisions of subsection 17.5.2.2 not later than March 16, 2000. The Division must determine whether these operational data are substantially equivalent to data collected under the provisions of subsection 17.5.2.2. These data must also be representative of Giardia lamblia inactivation through the entire treatment plant and not just of certain treatment segments. Until the Division approves this request, the system is required to conduct monitoring under the provisions of subsection 17.5.2.2.

17.5.2.3.2 In addition to the disinfection profile generated under subsection 17.5.2.2, a PWS that has existing operational data may use those data to develop a disinfection profile for additional years. Such systems may use these additional yearly disinfection profiles to develop a benchmark under the provisions of subsection 17.5.3. The Division must determine whether these operational data are substantially equivalent to data collected under the provisions of subsection 17.5.2.2. These data must also be representative of inactivation through the entire treatment plant and not just of certain treatment segments.

17.5.2.4 The system must calculate the total inactivation ratio as follows:

17.5.2.4.1 If the system uses only one point of disinfectant application, the system may determine the total inactivation ratio for the disinfection segment based on either of the methods in subsections 17.5.2.4.1.1 or 17.5.2.4.1.2.

17.5.2.4.1.1 Determine one inactivation ratio CTcalc/CT99.9 before or at the first customer during peak hourly flow.

17.5.2.4.1.2 Determine successive CTcalc/ CT99.9 values, representing sequential inactivation ratios, between the point of disinfectant application and a point before or at the first customer during peak hourly flow. Under this alternative, the system must calculate the total inactivation ratio by determining (CTcalc/CT99.9) for each sequence and then adding the (CTcalc/CT99.9) values together to determine (∑(CTcalc/ CT99.9)).

17.5.2.4.2 If the system uses more than one point of disinfectant application before the first customer, the system must determine the CT value of each disinfection segment immediately prior to the next point of disinfectant application, or for the final segment, before or at the first customer, during peak hourly flow. The (CTcalc/CT99.9) value of each segment and (∑(CTcalc/CT99.9)) must be calculated using the method in subsection 17.5.2.4.1.

17.5.2.4.3 The system must determine the total logs of inactivation by multiplying the value calculated in subsection 17.5.2.4.1 or 17.5.2.4.2 by 3.0.

17.5.2.5 A system that uses either chloramines or ozone for primary disinfection must also calculate the logs of inactivation for viruses using a method approved by the Division.

17.5.2.6 The system must retain disinfection profile data in graphic form, as a spreadsheet, or in some other format acceptable to the Division for review as part of sanitary surveys conducted by the Division.

17.5.3 Disinfection benchmarking.

17.5.3.1 Any system required to develop a disinfection profile under the provisions of subsections 17.5.1 and 17.5.2 and that decides to make a significant change to its disinfection practice must consult with the Division prior to making such change. Significant changes to disinfection practice are:

17.5.3.1.1 Changes to the point of disinfection;

17.5.3.1.2 Changes to the disinfectant(s) used in the treatment plant;

17.5.3.1.3 Changes to the disinfection process; and

17.5.3.1.4 Any other modification identified by the Division.

17.5.3.2 Any system that is modifying its disinfection practice must calculate its disinfection benchmark using the procedure specified in subsections 17.5.3.2.1 through 17.5.3.2.2.

17.5.3.2.1 For each year of profiling data collected and calculated under subsection 17.5.2, the system must determine the lowest average monthly Giardia lamblia inactivation in each year of profiling data. The system must determine the average Giardia lamblia inactivation for each calendar month for each year of profiling data by dividing the sum of daily Giardia lamblia of inactivation by the number of values calculated for that month.

17.5.3.2.2 The disinfection benchmark is the lowest monthly average value (for systems with one year of profiling data) or average of lowest monthly average values (for systems with more than one year of profiling data) of the monthly logs of Giardia lamblia inactivation in each year of profiling data.

17.5.3.2.3 A system that uses either chloramines or ozone for primary disinfection must also calculate the disinfection benchmark for viruses using a method approved by the Division.

17.5.3.2.4 The system must submit information in subsections 17.5.3.4.1 through 17.5.3.4.4 to the Division as part of its consultation process.

17.5.3.2.4.1 A description of the proposed change;

17.5.3.2.4.2 The disinfection profile for Giardia lamblia (and, if necessary, viruses) under subsection 17.5.2 and benchmark as required by subsection 17.5.3.2; and

17.5.3.2.4.3 An analysis of how the proposed change will affect the current levels of disinfection; and

17.5.3.2.4.4 Any additional information requested by the Division.

17.6 Filtration Interim Enhanced Surface Water Treatment Rule: A public water system subject to the requirements of this section must provide treatment consisting of both disinfection, as specified in subsection 16.3, and filtration treatment which complies with the requirements of subsections 17.6.1 or 17.6.2 or subsection 16.4 by December 17, 2001.

17.6.1 Conventional filtration treatment or direct filtration.

17.6.1.1 For systems using conventional filtration or direct filtration, the turbidity level of representative samples of a system's filtered water must be less than or equal to 0.3 NTU in at least 95 percent of the measurements taken each month, measured as specified in 40 CFR 141.74(a) and (c).

17.6.1.2 The turbidity level of representative samples of a system's filtered water must at no time exceed 1 NTU, measured as specified in 40 CFR 141.74(a) and (c).

17.6.1.3 A system that uses lime softening may acidify representative samples prior to analysis using a protocol approved by the Division.

17.6.2 Filtration technologies other than conventional filtration treatment, direct filtration, slow sand filtration, or diatomaceous earth filtration. A public water system may use a filtration technology not listed in subsection 17.6.1 or in 40 CFR 141.73(b) or (c) if it demonstrates to the Division, using pilot plant studies or other means, that the alternative filtration technology, in combination with disinfection treatment that meets the requirements of subsection 16.3, consistently achieves 99.9 percent removal and/or inactivation of Giardia lamblia cysts and 99.99 percent removal and/or inactivation of viruses, and 99 percent removal of Cryptosporidium oocysts, and the Division approves the use of the filtration technology. For each approval, the Division will set turbidity performance requirements that the system must meet at least 95 percent of the time and that the system may not exceed at any time at a level that consistently achieves 99.9 percent removal and/or inactivation of Giardia lamblia cysts, 99.99 percent removal and/or inactivation of viruses, and 99 percent removal of Cryptosporidium oocysts.

17.7 Filtration sampling requirements:

17.7.1 Monitoring requirements for systems using filtration treatment. In addition to monitoring required by 40 CFR 141.74, a public water system subject to the requirements of this section that provides conventional filtration treatment or direct filtration must conduct continuous monitoring of turbidity for each individual filter using an approved method in 40 CFR 141.74(a) and must calibrate turbidimeters using the procedure specified by the manufacturer. Systems must record the results of individual filter monitoring every 15 minutes.

17.7.2 If there is a failure in the continuous turbidity monitoring equipment, the system must conduct grab sampling every four hours in lieu of continuous monitoring, but for no more than five working days following the failure of the equipment.

17.8 Reporting and recordkeeping requirements: In addition to the reporting and recordkeeping requirements in 40 CFR 141.75, a public water system subject to the requirements of this section that provides conventional filtration treatment or direct filtration must report monthly to the Division the information specified in subsections 17.8.1 and 17.8.2 beginning December 17, 2001. In addition to the reporting and recordkeeping requirements in 40 CFR 141.75, a public water system subject to the requirements of this section that provides filtration approved under subsection 17.6.2 must report monthly to the Division the information specified in 17.8.1 beginning December 17, 2001. The reporting in subsection 17.8.1 is in lieu of the reporting specified in 40 CFR 141.75(b)(1).

17.8.1 Turbidity measurements as required by subsection 17.6 must be reported within 10 days after the end of each month the system serves water to the public. Information that must be reported includes:

17.8.1.1 The total number of filtered water turbidity measurements taken during the month.

17.8.1.2 The number and percentage of filtered water turbidity measurements taken during the month which are less than or equal to the turbidity limits specified in subsections 17.6.1 or 17.6.2.

17.8.1.3 The date and value of any turbidity measurements taken during the month which exceed 1 NTU for systems using conventional filtration treatment or direct filtration, or which exceed the maximum level set by the Division under subsection 17.6.2

17.8.2 Systems must maintain the results of individual filter monitoring taken under subsection 17.7 for at least three years. Systems must report that they have conducted individual filter turbidity monitoring under subsection 17.7 within 10 days after the end of each month the system serves water to the public. Systems must report individual filter turbidity measurement results taken under subsection 17.7 within 10 days after the end of each month the system serves water to the public only if measurements demonstrate one or more of the conditions in subsections 17.8.2.1 through 17.8.2.4. Systems that use lime softening may apply to the Division for alternative exceedance levels for the levels specified in subsections 17.8.2.1 through 17.8.2.4 if they can demonstrate that higher turbidity levels in individual filters are due to lime carryover only and not due to degraded filter performance.

17.8.2.1 For any individual filter that has a measured turbidity level of greater than 1.0 NTU in two consecutive measurements taken 15 minutes apart, the system must report the filter number, the turbidity measurement, and the date(s) on which the exceedance occurred. In addition, the system must either produce a filter profile for the filter within 7 days of the exceedance (if the system is not able to identify an obvious reason for the abnormal filter performance) and report that the profile has been produced or report the obvious reason for the exceedance.

17.8.2.2 For any individual filter that has a measured turbidity level of greater than 0.5 NTU in two consecutive measurements taken 15 minutes apart at the end of the first four hours of continuous filter operation after the filter has been backwashed or otherwise taken offline, the system must report the filter number, the turbidity, and the date(s) on which the exceedance occurred. In addition, the system must either produce a filter profile for the filter within 7 days of the exceedance (if the system is not able to identify an obvious reason for the abnormal filter performance) and report that the profile has been produced or report the obvious reason for the exceedance.

17.8.2.3 For any individual filter that has a measured turbidity level of greater than 1.0 NTU in two consecutive measurements taken 15 minutes apart at any time in each of three consecutive months, the system must report the filter number, the turbidity measurement, and the date(s) on which the exceedance occurred. In addition, the system must conduct a self-assessment of the filter within 14 days of the exceedance and report that the self-assessment was conducted. The self-assessment must consist of at least the following components: assessment of filter performance; development of a filter profile; identification and prioritization of factors limiting filter performance; assessment of the applicability of corrections; and preparation of a filter self-assessment report.

17.8.2.4 For any individual filter that has a measured turbidity level of greater than 2.0 NTU in two consecutive measurements taken 15 minutes apart at any time in each of two consecutive months, the system must report the filter number, the turbidity measurement, and the date(s) on which the exceedance occurred. In addition, the system must arrange for the conduct of a comprehensive performance evaluation (CPE), as defined in Section 2.0, by the Division or a third party approved by the Division no later than 30 days following the exceedance and have the evaluation completed and submitted to the Division no later than 90 days following the exceedance. In consultation with the Division, the water supplier must implement any follow-up recommendations that result, as part of the CPE.

17.8.3 Additional reporting requirements:

17.8.3.1 If at any time the turbidity exceeds 1 NTU in representative samples of filtered water in a system using conventional filtration treatment or direct filtration, the system must inform the Division as soon as possible, but no later than the end of the next business day.

17.8.3.2 If at any time the turbidity in representative samples of filtered water exceeds the maximum level set by the Division under subsection 17.9.2 for filtration technologies other than conventional filtration treatment, direct filtration, slow sand filtration, or diatomaceous earth filtration, the system must inform the Division as soon as possible, but no later than the end of the next business day.

**History**
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *25 DE Reg. 713 (01/01/22)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *5 DE Reg. 2121 (05/01/02)*
- *9 DE Reg. 999 (12/01/05)*
- *15 DE Reg. 73 (07/01/12)*
- *17 DE Reg. 439 (10/01/13)*
- *19 DE Reg. 517 (12/01/15)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *25 DE Reg. 713 (01/01/22)*

##### **16 Del. Admin. Code § 4462-18.0** Recycle Rule {#sec-4462-18.0 omnilex-key=us-de-regs-official--title-16--4462-18.0}

18.1 Applicability: All surface water or ground water under the direct influence of surface water systems that employ conventional filtration or direct filtration treatment and that recycle spent filter backwash water, thickener supernatant, or liquids from dewatering processes must meet the requirements in subsections 18.2 through 18.4.

18.2 Reporting: A system must notify the Division in writing by December 8, 2003 if the system recycles spent filter backwash water, thickener supernatant, or liquids from dewatering processes. This notification must include, at a minimum, the information specified in subsections 18.2.1 and 18.2.2.

18.2.1 A plant schematic showing the origin of all flows that are recycled (including, but not limited to, spent filter backwash water, thickener supernatant, and liquids from dewatering processes), the hydraulic conveyance used to transport them, and the location where they are reintroduced back into the treatment plant.

18.2.2 Typical recycle flow in gallons per minute (gpm), the highest observed plant flow experienced in the previous year (gpm), design flow for the treatment plant (gpm), and Division-approved operating capacity for the plant where the Division has made such a determination.

18.3 Treatment Technique Requirement: Any system that recycles spent filter backwash water, thickener supernatant, or liquids from dewatering processes must return these flows through the processes of a system’s existing conventional or direct filtration system as defined in Section 1.0 or at an alternate location approved by the Division by June 8, 2004. If capital improvements are required to modify the recycle location to meet this requirement, all capital improvements must be completed no later than June 8, 2006.

18.4 Recordkeeping: The system must collect and retain on file recycle flow information specified in subsections 18.4.1 through 18.4.6 for review and evaluation by the Division beginning June 8, 2004.

18.4.1 Copy of the recycle notification and information submitted to the Division under subsection 18.2.

18.4.2 List of all recycles flows and the frequency with which they are returned.

18.4.3 Average and maximum backwash flow rate through the filters and the average and maximum duration of the filter backwash process in minutes.

18.4.4 Typical filter run length and a written summary of how filter run length is determined.

18.4.5 The type of treatment provided for the recycle flow.

18.4.6 Data on the physical dimensions of the equalization and/or treatment units, typical and maximum hydraulic loading rates, type of treatment chemicals used and average dose and frequency of use, and frequency at which solids are removed, if applicable.

**History**
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *25 DE Reg. 713 (01/01/22)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *5 DE Reg. 2121 (05/01/02)*
- *9 DE Reg. 999 (12/01/05)*
- *15 DE Reg. 73 (07/01/12)*
- *17 DE Reg. 439 (10/01/13)*
- *19 DE Reg. 517 (12/01/15)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *25 DE Reg. 713 (01/01/22)*

##### **16 Del. Admin. Code § 4462-19.0** Enhanced Filtration and Disinfection – Systems Serving Fewer Than 10,000 People {#sec-4462-19.0 omnilex-key=us-de-regs-official--title-16--4462-19.0}

Additional requirements for the systems serving fewer than 10,000 people. In addition to complying with the requirements of Sections 16.0, 17.0, 18.0 and 20.0 of these regulations, systems using surface water or groundwater under the direct influence of surface water and serving fewer than 10,000 people must also comply with 40 CFR subpart T. Copies are available from the Office of Drinking Water.

**History**
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *25 DE Reg. 713 (01/01/22)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *5 DE Reg. 2121 (05/01/02)*
- *9 DE Reg. 999 (12/01/05)*
- *15 DE Reg. 73 (07/01/12)*
- *17 DE Reg. 439 (10/01/13)*
- *19 DE Reg. 517 (12/01/15)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *25 DE Reg. 713 (01/01/22)*

##### **16 Del. Admin. Code § 4462-20.0** Enhanced Treatment for Cryptosporidium {#sec-4462-20.0 omnilex-key=us-de-regs-official--title-16--4462-20.0}

20.1 General requirements for the Long Term 2 Enhanced Surface Water Treatment Rule.

20.1.1 The requirements of Section 20.0 are national primary drinking water regulations. The regulations in this section establish or extend treatment technique requirements in lieu of maximum contaminant levels for Cryptosporidium. These requirements are in addition to requirements for filtration and disinfection in Sections 16.0, 17.0, and 19.0 of these regulations.

20.1.2 Applicability. The requirements of this section apply to all subpart H systems, which are public water systems supplied by a surface water source and public water systems supplied by a ground water source under the direct influence of surface water.

20.1.2.1 Wholesale systems, as defined in Section 1.0, must comply with the requirements of this section based on the population of the largest system in the combined distribution system.

20.1.2.2 The requirements of this section for filtered systems apply to systems required by National Primary Drinking Water Regulations to provide filtration treatment, whether or not the system is currently operating a filtration system.

20.1.2.3 The requirements of this section for unfiltered systems apply only to unfiltered systems that timely met and continue to meet the filtration avoidance criteria in Sections 16.0, 17.0, and 19.0 of this regulation, as applicable.

20.1.3 Requirements. Systems subject to this section must comply with the following requirements:

20.1.3.1 Systems must conduct an initial and a second round of source water monitoring for each plant that treats a surface water or GWUDI source. This monitoring may include sampling for Cryptosporidium, E. coli, and turbidity as described in subsections 20.2 through 20.7, to determine what level, if any, of additional Cryptosporidium treatment they must provide.

20.1.3.2 Systems that plan to make a significant change to their disinfection practice must develop disinfection profiles and calculate disinfection benchmarks, as described in subsections 20.9 through 20.10.

20.1.3.3 Filtered systems must determine their Cryptosporidium treatment bin classification as described in subsection 20.11 and provide additional treatment for Cryptosporidium, if required, as described in subsection 20.12. All unfiltered systems must provide treatment for Cryptosporidium as described in subsection 20.13. Filtered and unfiltered systems must implement Cryptosporidium treatment according to the schedule in subsection 20.14.

20.1.3.4 Systems with uncovered finished water storage facilities must comply with the requirements to cover the facility or treat the discharge from the facility as described in subsection 20.15.

20.1.3.5 Systems required to provide additional treatment for Cryptosporidium must implement microbial toolbox options that are designed and operated as described in subsections 20.16 through 20.21.

20.1.3.6 Systems must comply with the applicable recordkeeping and reporting requirements described in subsections 20.22 through 20.23.

20.1.3.7 Systems must address significant deficiencies identified in sanitary surveys performed by the Division as described in subsection 20.24.

20.2 Source water monitoring.

20.2.1 Initial round of source water monitoring. Systems must conduct the following monitoring on the schedule in subsection 20.4 of this section unless they meet the monitoring exemption criteria in subsection 20.2.3.

20.2.1.1 Filtered systems serving at least 10,000 people must sample their source water for Cryptosporidium, E. coli, and turbidity at least monthly for 24 months.

20.2.1.2 Unfiltered systems serving at least 10,000 people must sample their source water for Cryptosporidium at least monthly for 24 months.

20.2.1.3 Filtered Systems

20.2.1.3.1 Filtered systems serving fewer than 10,000 people must sample their source water for E. coli at least once every two weeks for 12 months.

20.2.1.3.2 A filtered system serving fewer than 10,000 people may avoid E. coli monitoring if the system notifies the Division that it will monitor for Cryptosporidium as described in subsection 20.2.1.4. The system must notify the Division no later than 3 months prior to the date the system is otherwise required to start E. coli monitoring under subsection 20.2.3.

20.2.1.4 Filtered systems serving fewer than 10,000 people must sample their source water for Cryptosporidium at least twice per month for 12 months or at least monthly for 24 months if they meet one of the following, based on monitoring conducted under subsection 20.2.1.3.1:

20.2.1.4.1 For systems using lake/reservoir sources, the annual mean E. coli concentration is greater than 10 E. coli/100 mL.

20.2.1.4.2 For systems using flowing stream sources, the annual mean E. coli concentration is greater than 50 E. coli/100 mL.

20.2.1.4.3 The system does not conduct E. coli monitoring as described in subsection 20.2.1.3.1.

20.2.1.4.4 Systems using ground water under the direct influence of surface water (GWUDI) must comply with the requirements of subsection 20.2.1.4 based on the E. coli level that applies to the nearest surface water body. If no surface water body is nearby, the system must comply based on the requirements that apply to systems using lake/reservoir sources.

20.2.1.5 For filtered systems serving fewer than 10,000 people, the Division may approve monitoring for an indicator other than E. coli under subsections 20.2.1.3.1 and 20.2.1.3.2. The Division also may approve an alternative to the E. coli concentration in subsections 20.2.1.4.1, 20.2.1.4.2 or 20.2.1.4.4 of this section to trigger Cryptosporidium monitoring. This approval by the Division must be provided to the system in writing and must include the basis for the Division's determination that the alternative indicator and/or trigger level will provide a more accurate identification of whether a system will exceed the Bin 1 Cryptosporidium level in subsection 20.11.

20.2.1.6 Unfiltered systems serving fewer than 10,000 people must sample their source water for Cryptosporidium at least twice per month for 12 months or at least monthly for 24 months.

20.2.1.7 Systems may sample more frequently than required under this section if the sampling frequency is evenly spaced throughout the monitoring period.

20.2.2 Second round of source water monitoring. Systems must conduct a second round of source water monitoring that meets the requirements for monitoring parameters, frequency, and duration described in subsection 20.2.1, unless they meet the monitoring exemption criteria in subsection 20.2.4. Systems must conduct this monitoring on the schedule in subsection 20.2.3.

20.2.3 Monitoring schedule. Systems must begin the monitoring required in subsections 20.2.1 and 20.2.2 no later than the month beginning with the date listed in this table:

Source Water Monitoring Starting Dates Table

20.2.4 Monitoring avoidance.

20.2.4.1 Filtered systems are not required to conduct source water monitoring under this section if the system will provide a total of at least 5.5-log of treatment for Cryptosporidium, equivalent to meeting the treatment requirements of Bin 4 in subsection 20.12.

20.2.4.2 Unfiltered systems are not required to conduct source water monitoring under this section if the system will provide a total of at least 3-log Cryptosporidium inactivation, equivalent to meeting the treatment requirements for unfiltered systems with a mean Cryptosporidium concentration of greater than 0.01 oocysts/L in subsection 20.13.

20.2.4.3 If a system chooses to provide the level of treatment in subsections 20.2.4.1 or 20.2.4.2, as applicable, rather than start source water monitoring, the system must notify the Division in writing no later than the date the system is otherwise required to submit a sampling schedule for monitoring under subsection 20.3. Alternatively, a system may choose to stop sampling at any point after it has initiated monitoring if it notifies the Division in writing that it will provide this level of treatment. Systems must install and operate technologies to provide this level of treatment by the applicable treatment compliance date in subsection 20.14.

20.2.5 Plants operating only part of the year. Systems with surface water or ground water under the direct influence of surface water plants that operate for only part of the year must conduct source water monitoring in accordance with this section, but with the following modifications:

20.2.5.1 Systems must sample their source water only during the months that the plant operates unless the Division specifies another monitoring period based on plant operating practices.

20.2.5.2 Systems with plants that operate less than six months per year and that monitor for Cryptosporidium must collect at least six Cryptosporidium samples per year during each of two years of monitoring. Samples must be evenly spaced throughout the period the plant operates.

20.2.6 New sources.

20.2.6.1 A system that begins using a new source of surface water or GWUDI after the system is required to begin monitoring under subsection 20.2.3 must monitor the new source on a schedule the Division approves. Source water monitoring must meet the requirements of this section. The system must also meet the bin classification and Cryptosporidium treatment requirements of subsections 20.11 and 20.12 or subsection 20.13, as applicable, for the new source on a schedule the Division approves.

20.2.6.2 The requirements of subsection 20.2.6 apply to surface water or ground water under the direct influence of surface water systems that begin operation after the monitoring start date applicable to the system's size under subsection 20.2.3.

20.2.6.3 The system must begin a second round of source water monitoring no later than 6 years following initial bin classification under subsection 20.11 or determination of the mean Cryptosporidium level under subsection 20.13 as applicable.

20.2.7 Failure to collect any source water sample required under this section in accordance with the sampling schedule, sampling location, analytical method, approved laboratory, and reporting requirements of subsections 20.3 through 20.7 is a monitoring violation.

20.2.8 Grandfathering monitoring data. Systems may use (grandfather) monitoring data collected prior to the applicable monitoring start date in subsection 20.2.3 to meet the initial source water monitoring requirements in subsection 20.2.1. Grandfathered data may substitute for an equivalent number of months at the end of the monitoring period. All data submitted under this paragraph must meet the requirements in subsection 20.8.

20.3 Sampling schedules.

20.3.1 Systems required to conduct source water monitoring under subsection 20.2 must submit a sampling schedule that specifies the calendar dates when the system will collect each required sample.

20.3.1.1 Systems must submit sampling schedules no later than 3 months prior to the applicable date listed in subsection 20.2.3 for each round of required monitoring.

20.3.1.1.1 Systems serving at least 10,000 people must submit their sampling schedule for the initial round of source water monitoring under subsection 20.2.1 to EPA electronically at https://intranet.epa.gov/lt2/.

20.3.1.1.2 If a system is unable to submit the sampling schedule electronically, the system may use an alternative approach for submitting the sampling schedule that EPA approves.

20.3.1.2 Systems serving fewer than 10,000 people must submit their sampling schedules for the initial round of source water monitoring under subsection 20.2.1 to the Division.

20.3.1.3 Systems must submit sampling schedules for the second round of source water monitoring conducted under subsection 20.2.2 to the Division.

20.3.1.4 If EPA or the Division does not respond to a system regarding its sampling schedule, the system must sample at the reported schedule.

20.3.2 Systems must collect samples within two days before or two days after the dates indicated in their sampling schedule (i.e., within a five-day period around the schedule date) unless one of the conditions of subsections 20.3.2.1 or 20.3.2.1.1 applies.

20.3.2.1 If an extreme condition or situation exists that may pose danger to the sample collector, or that cannot be avoided and causes the system to be unable to sample in the scheduled five-day period, the system must sample as close to the scheduled date as is feasible unless the Division approves an alternative sampling date. The system must submit an explanation for the delayed sampling date to the Division concurrent with the shipment of the sample to the laboratory.

20.3.2.1.1 If a system is unable to report a valid analytical result for a scheduled sampling date due to equipment failure, loss of or damage to the sample, failure to comply with the analytical method requirements, including the quality control requirements in subsection 20.5, or the failure of an approved laboratory to analyze the sample, then the system must collect a replacement sample.

20.3.2.1.2 The system must collect the replacement sample not later than 21 days after receiving information that an analytical result cannot be reported for the scheduled date unless the system demonstrates that collecting a replacement sample within this time frame is not feasible or the Division approves an alternative resampling date. The system must submit an explanation for the delayed sampling date to the Division concurrent with the shipment of the sample to the laboratory.

20.3.3 Systems that fail to meet the criteria of subsection 20.3.2 of this subsection for any source water sample required under subsection 20.2 must revise their sampling schedules to add dates for collecting all missed samples. Systems must submit the revised schedule to the Division for approval prior to when the system begins collecting the missed samples.

20.4 Sampling locations.

20.4.1 Systems required to conduct source water monitoring under subsection 20.2 must collect samples for each plant that treats a surface water or GWUDI source. Where multiple plants draw water from the same influent, such as the same pipe or intake, the Division may approve one set of monitoring results to be used to satisfy the requirements of subsection 20.2 for all plants.

20.4.2 Source water samples

20.4.2.1 Systems must collect source water samples prior to chemical treatment, such as coagulants, oxidants and disinfectants, unless the system meets the condition of subsection 20.4.2.2.

20.4.2.2 The Division may approve a system to collect a source water sample after chemical treatment. To grant this approval, the Division must determine that collecting a sample prior to chemical treatment is not feasible for the system and that the chemical treatment is unlikely to have a significant adverse effect on the analysis of the sample.

20.4.3 Systems that recycle filter backwash water must collect source water samples prior to the point of filter backwash water addition.

20.4.4 Bank filtration.

20.4.4.1 Systems that receive Cryptosporidium treatment credit for bank filtration under subsections 10.4.4 or 10.4.5, as applicable, must collect source water samples in the surface water prior to bank filtration.

20.4.4.2 Systems that use bank filtration as pretreatment to a filtration plant must collect source water samples from the well (i.e., after bank filtration). Use of bank filtration during monitoring must be consistent with routine operational practice. Systems collecting samples after a bank filtration process may not receive treatment credit for the bank filtration under subsection 20.18.3.

20.4.5 Multiple sources. Systems with plants that use multiple water sources, including multiple surface water sources and blended surface water and ground water sources, must collect samples as specified in subsections 20.4.5.1 or 20.4.5.2. The use of multiple sources during monitoring must be consistent with routine operational practice.

20.4.5.1 If a sampling tap is available where the sources are combined prior to treatment, systems must collect samples from the tap.

20.4.5.2 If a sampling tap where the sources are combined prior to treatment is not available, systems must collect samples at each source near the intake on the same day and must follow either subsections 20.4.5.2.1 or 20.4.5.2.2 of this subsection for sample analysis.

20.4.5.2.1 Systems may composite samples from each source into one sample prior to analysis. The volume of sample from each source must be weighted according to the proportion of the source in the total plant flow at the time the sample is collected.

20.4.5.2.2 Systems may analyze samples from each source separately and calculate a weighted average of the analysis results for each sampling date. The weighted average must be calculated by multiplying the analysis result for each source by the fraction the source contributed to total plant flow at the time the sample was collected and then summing these values.

20.4.6 Additional Requirements. Systems must submit a description of their sampling location(s) to the Division at the same time as the sampling schedule required under subsection 20.3. This description must address the position of the sampling location in relation to the system's water source(s) and treatment processes, including pretreatment, points of chemical treatment, and filter backwash recycle. If the Division does not respond to a system regarding sampling location(s), the system must sample at the reported location(s).

20.5 Analytical methods.

20.5.1 Cryptosporidium. Systems must analyze for Cryptosporidium using Method 1623: Cryptosporidium and Giardia in Water by Filtration/IMS/FA, 2005, United States Environmental Protection Agency, EPA-815-R-05-002 or Method 1622: Cryptosporidium in Water by Filtration/IMS/FA, 2005, United States Environmental Protection Agency, EPA-815-R-05-001, which are incorporated by reference. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy of these methods online from the United States Environmental Protection Agency, Office of Ground Water and Drinking Water, 1201 Constitution Ave., NW, Washington, DC 20460 (Telephone: 800-426-4791). You may inspect a copy at the Water Docket in the EPA Docket Center, 1301 Constitution Ave., NW, Washington, DC, (Telephone: 202-566-2426) or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

20.5.1.1 Systems must analyze at least a 10 L sample or a packed pellet volume of at least 2 mL as generated by the methods listed in subsection 20.5.1. Systems unable to process a 10 L sample must analyze as much sample volume as can be filtered by two filters approved by EPA for the methods listed in subsection 20.5.1, up to a packed pellet volume of at least 2 mL.

20.5.1.2 Matrix Spike samples

20.5.1.2.1 Matrix spike (MS) samples, as required by the methods in subsection 20.5.1, must be spiked and filtered by a laboratory approved for Cryptosporidium analysis under subsection 20.5.

20.5.1.2.2 If the volume of the MS sample is greater than 10 L, the system may filter all but 10 L of the MS sample in the field, and ship the filtered sample and the remaining 10 L of source water to the laboratory. In this case, the laboratory must spike the remaining 10 L of water and filter it through the filter used to collect the balance of the sample in the field.

20.5.1.3 Flow cytometer-counted spiking suspensions must be used for MS samples and ongoing precision and recovery (OPR) samples.

20.5.2 E. coli. Systems must use methods for enumeration of E. coli in source water approved in subsection 16.6.

20.5.2.1 The time from sample collection to initiation of analysis may not exceed 30 hours unless the system meets the condition of subsection 20.5.2.2.

20.5.2.2 The Division may approve on a case-by-case basis the holding of an E. coli sample for up to 48 hours between sample collection and initiation of analysis if the Division determines that analyzing an E. coli sample within 30 hours is not feasible. E. coli samples held between 30 to 48 hours must be analyzed by the Colilert reagent version of Standard Method 9223B as listed in subsection 10.6 of this regulation.

20.5.2.3 Systems must maintain samples between 0ºC and 10ºC during storage and transit to the laboratory.

20.5.3 Turbidity. Systems must use methods for turbidity measurement approved in subsection 16.6.

20.6 Approved laboratories.

20.6.1 Cryptosporidium. Systems must have Cryptosporidium samples analyzed by a laboratory that is approved under EPA's Laboratory Quality Assurance Evaluation Program for Analysis of Cryptosporidium in Water or a laboratory that has been certified for Cryptosporidium analysis by an equivalent Division laboratory certification program.

20.6.2 E. coli. Any laboratory certified by the EPA, the National Environmental Laboratory Accreditation Conference or the Division for total coliform or fecal coliform analysis under subsection 16.6 is approved for E. coli analysis under this subsection when the laboratory uses the same technique for E. coli that the laboratory uses for subsection 16.6.

20.6.3 Turbidity. Measurements of turbidity must be made by a party approved by the Division.

20.7 Reporting source water monitoring results.

20.7.1 Systems must report results from the source water monitoring required under subsection 20.2 no later than 10 days after the end of the first month following the month when the sample is collected.

20.7.2 Electronic Reporting

20.7.2.1 All systems serving at least 10,000 people must report the results from the initial source water monitoring required under subsection 20.2.1 to EPA electronically at https://intranet.epa.gov/lt2/ (dated compliance requirement retained for Federal consistency; link not active).

20.7.2.2 If a system is unable to report monitoring results electronically, the system may use an alternative approach for reporting monitoring results that EPA approves.

20.7.3 Systems serving fewer than 10,000 people must report results from the initial source water monitoring required under subsection 20.2.1 to the Division.

20.7.4 All systems must report results from the second round of source water monitoring required under subsection 20.2.2 to the Division.

20.7.5 Systems must report the applicable information in subsections 20.7.5.1 and 20.7.5.2 for the source water monitoring required under section 20.2.

20.7.5.1 Systems must report the following data elements for each Cryptosporidium analysis:

Data element

PWS ID.

Facility ID.

Sample collection date.

Sample type (field or matrix spike).

Sample volume filtered (L), to nearest 1/4\ L.

Was 100% of filtered volume examined.

Number of oocysts counted.

20.7.5.1.1 For matrix spike samples, systems must also report the sample volume spiked and estimated number of oocysts spiked. These data are not required for field samples.

20.7.5.1.2 For samples in which less than 10 L is filtered or less than 100% of the sample volume is examined, systems must also report the number of filters used and the packed pellet volume.

20.7.5.1.3 For samples in which less than 100% of sample volume is examined, systems must also report the volume of resuspended concentrate and volume of this resuspension processed through immunomagnetic separation.

20.7.5.2 Systems must report the following data elements for each E. coli analysis:

Data element

PWS ID.

Facility ID.

Sample collection date.

Analytical method number.

Method type.

Source type (flowing stream, lake/reservoir, GWUDI).

E. coli/100 mL.

Turbidity.1

20.8 Grandfathering previously collected data.

20.8.1 Grandfathering

20.8.1.1 Systems may comply with the initial source water monitoring requirements of subsection 20.2.1 by grandfathering sample results collected before the system is required to begin monitoring (i.e., previously collected data). To be grandfathered, the sample results and analysis must meet the criteria in this section and the Division must approve.

20.8.1.2 A filtered system may grandfather Cryptosporidium samples to meet the requirements of subsection 20.2.1 when the system does not have corresponding E. coli and turbidity samples. A system that grandfathers Cryptosporidium samples without E. coli and turbidity samples is not required to collect E. coli and turbidity samples when the system completes the requirements for Cryptosporidium monitoring under subsection 20.2.1.

20.8.2 E. coli sample analysis. The analysis of E. coli samples must meet the analytical method and approved laboratory requirements of subsections 20.5 through 20.6.

20.8.3 Cryptosporidium sample analysis. The analysis of Cryptosporidium samples must meet the criteria in this paragraph.

20.8.3.1 Laboratories analyzed Cryptosporidium samples using one of the analytical methods in subsections 20.8.3.1.1 through 20.8.3.1.6, which are incorporated by reference. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy of these methods on-line from the United States Environmental Protection Agency, Office of Ground Water and Drinking Water, 1201 Constitution Ave, NW, Washington, DC 20460 (Telephone: 800-426-4791). You may inspect a copy at the Water Docket in the EPA Docket Center, 1301 Constitution Ave., NW, Washington, DC, (Telephone: 202-566-2426) or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code--of--federal--regulations/ibr--locations.html.

20.8.3.1.1 Method 1623: Cryptosporidium and Giardia in Water by Filtration/IMS/FA, 2005, United States Environmental Protection Agency, EPA-815-R-05-002.

20.8.3.1.2 Method 1622: Cryptosporidium in Water by Filtration/IMS/FA, 2005, United States Environmental Protection Agency, EPA-815-R-05-001.

20.8.3.1.3 Method 1623: Cryptosporidium and Giardia in Water by Filtration/IMS/FA, 2001, United States Environmental Protection Agency, EPA-821-R-01-025.

20.8.3.1.4 Method 1622: Cryptosporidium in Water by Filtration/IMS/FA, 2001, United States Environmental Protection Agency, EPA-821--R-01-026.

20.8.3.1.5 Method 1623: Cryptosporidium and Giardia in Water by Filtration/IMS/FA, 1999, United States Environmental Protection Agency, EPA-821-R-99-006.

20.8.3.1.6 Method 1622: Cryptosporidium in Water by Filtration/IMS/FA, 1999, United States Environmental Protection Agency, EPA-821-R-99-001.

20.8.3.2 For each Cryptosporidium sample, the laboratory analyzed at least 10 L of sample or at least 2 mL of packed pellet or as much volume as could be filtered by 2 filters that EPA approved for the methods listed in subsection 20.8.3.1.

20.8.4 Sampling location. The sampling location must meet the conditions in subsection 20.4.

20.8.5 Sampling frequency. Cryptosporidium samples were collected no less frequently than each calendar month on a regular schedule, beginning no earlier than January 1999. Sample collection intervals may vary for the conditions specified in subsections 20.3.2.1 and 20.3.2.2 if the system provides documentation of the condition when reporting monitoring results.

20.8.5.1 The Division may approve grandfathering of previously collected data where there are time gaps in the sampling frequency if the system conducts additional monitoring the Division specifies to ensure that the data used to comply with the initial source water monitoring requirements of subsection 20.2.1 are seasonally representative and unbiased.

20.8.5.2 Systems may grandfather previously collected data where the sampling frequency within each month varied. If the Cryptosporidium sampling frequency varied, systems must follow the monthly averaging procedure in subsections 20.11.2.5 or 20.13.1.3, as applicable, when calculating the bin classification for filtered systems or the mean Cryptosporidium concentration for unfiltered systems.

20.8.6 Reporting monitoring results for grandfathering. Systems that request to grandfather previously collected monitoring results must report the following information by the applicable dates listed in this paragraph. Systems serving at least 10,000 people must report this information to EPA unless the Division approves reporting to the Division rather than EPA. Systems serving fewer than 10,000 people must report this information to the Division.

20.8.6.1 Systems must report that they intend to submit previously collected monitoring results for grandfathering. This report must specify the number of previously collected results the system will submit, the dates of the first and last sample, and whether a system will conduct additional source water monitoring to meet the requirements of subsection 20.2.1. Systems must report this information no later than the date the sampling schedule under subsection 20.3 is required.

20.8.6.2 Systems must report previously collected monitoring results for grandfathering, along with the associated documentation listed in subsections 20.8.6.2.1 through 20.8.6.2.4, no later than two months after the applicable date listed in subsection 20.2.3.

20.8.6.2.1 For each sample result, systems must report the applicable data elements in subsection 20.8.

20.8.6.2.2 Systems must certify that the reported monitoring results include all results the system generated during the time period beginning with the first reported result and ending with the final reported result. This applies to samples that were collected from the sampling location specified for source water monitoring under this section, not spiked, and analyzed using the laboratory's routine process for the analytical methods listed in this section.

20.8.6.2.3 Systems must certify that the samples were representative of a plant's source water(s) and the source water(s) have not changed. Systems must report a description of the sampling location(s), which must address the position of the sampling location in relation to the system's water source(s) and treatment processes, including points of chemical addition and filter backwash recycle.

20.8.6.2.4 For Cryptosporidium samples, the laboratory or laboratories that analyzed the samples must provide a letter certifying that the quality control criteria specified in the methods listed in subsection 20.8.3.1 were met for each sample batch associated with the reported results. Alternatively, the laboratory may provide bench sheets and sample examination report forms for each field, matrix spike, IPR, OPR, and method blank sample associated with the reported results.

20.8.7 If the Division determines that a previously collected data set submitted for grandfathering was generated during source water conditions that were not normal for the system, such as a drought, the Division may disapprove the data. Alternatively, the Division may approve the previously collected data if the system reports additional source water monitoring data, as determined by the Division, to ensure that the data set used under subsections 20.11 or 20.13 represents average source water conditions for the system.

20.8.8 If a system submits previously collected data that fully meet the number of samples required for initial source water monitoring under subsection 20.2.1 and some of the data are rejected due to not meeting the requirements of this section, systems must conduct additional monitoring to replace rejected data on a schedule the Division approves. Systems are not required to begin this additional monitoring until two months after notification that data have been rejected and additional monitoring is necessary.

20.9 Requirements when making a significant change in disinfection practice.

20.9.1 Following the completion of initial source water monitoring under subsection 20.2.1, a system that plans to make a significant change to its disinfection practice, as defined in subsection 20.9.2, must develop disinfection profiles and calculate disinfection benchmarks for Giardia lamblia and viruses as described in subsection 20.10. Prior to changing the disinfection practice, the system must notify the Division and must include in this notice the information in subsections 20.9.1.1 through 20.9.1.3;

20.9.1.1 A completed disinfection profile and disinfection benchmark for Giardia lamblia and viruses as described in subsection 20.10;

20.9.1.2 A description of the proposed change in disinfection practice; and

20.9.1.3 An analysis of how the proposed change will affect the current level of disinfection.

20.9.2 Significant changes to disinfection practice are defined as follows:

20.9.2.1 Changes to the point of disinfection;

20.9.2.2 Changes to the disinfectant(s) used in the treatment plant;

20.9.2.3 Changes to the disinfection process; or

20.9.2.4 Any other modification identified by the Division as a significant change to disinfection practice.

20.10 Developing the disinfection profile and benchmark

20.10.1 Systems required to develop disinfection profiles under subsection 20.9 must follow the requirements of this section. Systems must monitor at least weekly for a period of 12 consecutive months to determine the total log inactivation for Giardia lamblia and viruses. If systems monitor more frequently, the monitoring frequency must be evenly spaced. Systems that operate for fewer than 12 months per year must monitor weekly during the period of operation. Systems must determine log inactivation for Giardia lamblia through the entire plant, based on CT99.9 values in Tables 1.1 through 1.6, 2.1 and 3.1 of 40 CFR §141.74(b) as applicable. Copies are available from the Office of Drinking Water upon request. Systems must determine log inactivation for viruses through the entire treatment plant based on a protocol approved by the Division.

20.10.2 Systems with a single point of disinfectant application prior to the entrance to the distribution system must conduct the monitoring in subsections 20.10.2.1 through 20.10.2.4. Systems with more than one point of disinfectant application must conduct the monitoring in subsections 20.10.2.1 through 20.10.2.4 for each disinfection segment. Systems must monitor the parameters necessary to determine the total inactivation ratio, using analytical methods in subsection 16.6.

20.10.2.1 For systems using a disinfectant other than UV, the temperature of the disinfected water must be measured at each residual disinfectant concentration sampling point during peak hourly flow or at an alternative location approved by the Division.

20.10.2.2 For systems using chlorine, the pH of the disinfected water must be measured at each chlorine residual disinfectant concentration sampling point during peak hourly flow or at an alternative location approved by the Division.

20.10.2.3 The disinfectant contact time(s) (T) must be determined during peak hourly flow.

20.10.2.4 The residual disinfectant concentration(s) (C) of the water before or at the first customer and prior to each additional point of disinfectant application must be measured during peak hourly flow.

20.10.3 In lieu of conducting new monitoring under subsection 20.10.2, systems may elect to meet the requirements of subsection 20.10.3.1 or 20.10.3.2 of this section.

20.10.3.1 Systems that have at least one year of existing data that are substantially equivalent to data collected under the provisions of subsection 20.10.2 may use these data to develop disinfection profiles as specified in this section if the system has neither made a significant change to its treatment practice nor changed sources since the data were collected. Systems may develop disinfection profiles using up to three years of existing data.

20.10.3.2 Systems may use disinfection profile(s) developed under subsection 17.5 or Subpart H systems serving fewer than 10,000 people may use disinfection profiles developed under subsection 19.1 in lieu of developing a new profile if the system has neither made a significant change to its treatment practice nor changed sources since the profile was developed. Systems that have not developed a virus profile under subsection 17.5 or Subpart H systems serving fewer than 10,000 people under subsection 19.1 must develop a virus profile using the same monitoring data on which the Giardia lamblia profile is based.

20.10.4 Systems must calculate the total inactivation ratio for Giardia lamblia as specified in subsections 20.10.4.1 through 20.10.4.3.

20.10.4.1 Systems using only one point of disinfectant application may determine the total inactivation ratio for the disinfection segment based on either of the methods in subsection 20.10.4.1.1 or 20.10.4.1.2.

20.10.4.1.1 Determine one inactivation ratio (CTcalc/CT99.9) before or at the first customer during peak hourly flow.

20.10.4.1.2 Determine successive CTcalc/CT99.9 values, representing sequential inactivation ratios, between the point of disinfectant application and a point before or at the first customer during peak hourly flow. The system must calculate the total inactivation ratio by determining (CTcalc/CT99.9) for each sequence and then adding the (CTcalc/CT99.9) values together to determine (∑(CTcalc/CT99.9)).

20.10.4.2 Systems using more than one point of disinfectant application before the first customer must determine the CT value of each disinfection segment immediately prior to the next point of disinfectant application, or for the final segment, before or at the first customer, during peak hourly flow. The (CTcalc/CT99.9) value of each segment and (∑(CTcalc/CT99.9)) must be calculated using the method in subsection 20.10.4.1.2.

20.10.4.3 The system must determine the total logs of inactivation by multiplying the value calculated in subsections 20.10.4.1 or 20.10.4.2 by 3.0.

20.10.4.4 Systems must calculate the log of inactivation for viruses using a protocol approved by the Division.

20.10.5 Systems must use the procedures specified in subsections 20.10.5.1 and 20.10.5.2 to calculate a disinfection benchmark.

20.10.5.1 For each year of profiling data collected and calculated under subsections 20.10.1 through 20.10.4, systems must determine the lowest mean monthly level of both Giardia lamblia and virus inactivation. Systems must determine the mean Giardia lamblia and virus inactivation for each calendar month for each year of profiling data by dividing the sum of daily or weekly Giardia lamblia and virus log inactivation by the number of values calculated for that month.

20.10.5.2 The disinfection benchmark is the lowest monthly mean value (for systems with one year of profiling data) or the mean of the lowest monthly mean values (for systems with more than one year of profiling data) of Giardia lamblia and virus log inactivation in each year of profiling data.

20.11 Bin classification for filtered systems

20.11.1 Following completion of the initial round of source water monitoring required under subsection 20.2.1, filtered systems must calculate an initial Cryptosporidium bin concentration for each plant for which monitoring was required. Calculation of the bin concentration must use the Cryptosporidium results reported under subsection 20.2.1 and must follow the procedures in subsections 20.11.2.1 through 20.11.2.5.

20.11.2 Bin classification

20.11.2.1 For systems that collect a total of at least 48 samples, the bin concentration is equal to the arithmetic mean of all sample concentrations.

20.11.2.2 For systems that collect a total of at least 24 samples, but not more than 47 samples, the bin concentration is equal to the highest arithmetic mean of all sample concentrations in any 12 consecutive months during which Cryptosporidium samples were collected.

20.11.2.3 For systems that serve fewer than 10,000 people and monitor for Cryptosporidium for only one year (i.e., collect 24 samples in 12 months), the bin concentration is equal to the arithmetic mean of all sample concentrations.

20.11.2.4 For systems with plants operating only part of the year that monitor fewer than 12 months per year under subsection 20.2.5, the bin concentration is equal to the highest arithmetic mean of all sample concentrations during any year of Cryptosporidium monitoring.

20.11.2.5 If the monthly Cryptosporidium sampling frequency varies, systems must first calculate a monthly average for each month of monitoring. Systems must then use these monthly average concentrations, rather than individual sample concentrations, in the applicable calculation for bin classification in subsections 20.11.2.1 through 20.11.2.4.

20.11.3 Filtered systems must determine their initial bin classification from the following table and using the Cryptosporidium bin concentration calculated under subsections 20.11.1 and 20.11.2:

Bin Classification Table for Filtered Systems

20.11.4 Following completion of the second round of source water monitoring required under subsection 20.2.2, filtered systems must recalculate their Cryptosporidium bin concentration using the Cryptosporidium results reported under subsection 20.2.2 and following the procedures in subsections 20.11.2.1 through 20.11.2.4. Systems must then re-determine their bin classification using this bin concentration and the table in subsection 20.11.3.

20.11.5 Reporting bin classification

20.11.5.1 Filtered systems must report their initial bin classification under subsection 20.11.3 to the Division for approval no later than 6 months after the system is required to complete initial source water monitoring based on the schedule in subsection 20.3.

20.11.5.2 Systems must report their bin classification under subsection 20.11.4 to the Division for approval no later than 6 months after the system is required to complete the second round of source water monitoring based on the schedule in subsection 20.2.3.

20.11.5.3 The bin classification report to the Division must include a summary of source water monitoring data and the calculation procedure used to determine bin classification.

20.11.6 Failure to comply with the conditions of subsection 20.11.5 is a violation of the treatment technique requirement.

20.12 Filtered system additional Cryptosporidium treatment requirements

20.12.1 Filtered systems must provide the level of additional treatment for Cryptosporidium specified in this paragraph based on their bin classification as determined under subsection 20.11 and according to the schedule in subsection 20.14.

20.12.2 Treatment options

20.12.2.1 Filtered systems must use one or more of the treatment and management options listed in subsection 20.16, termed the microbial toolbox, to comply with the additional Cryptosporidium treatment required in subsection 20.12.1.

20.12.2.2 Systems classified in Bin 3 and Bin 4 must achieve at least 1-log of the additional Cryptosporidium treatment required under subsection 20.12.1 using either one or a combination of the following: bag filters, bank filtration, cartridge filters, chlorine dioxide, membranes, ozone, or UV, as described in subsections 20.17 through 20.21.

20.12.3 Failure by a system in any month to achieve treatment credit by meeting criteria in subsections 20.17 through 20.21 for microbial toolbox options that is at least equal to the level of treatment required in subsection 20.12.1 is a violation of the treatment technique requirement.

20.12.4 If the Division determines during a sanitary survey or an equivalent source water assessment that after a system completed the monitoring conducted under subsection 20.2.1 or subsection 20.2.2, significant changes occurred in the system's watershed that could lead to increased contamination of the source water by Cryptosporidium, the system must take actions specified by the Division to address the contamination. These actions may include additional source water monitoring and/or implementing microbial toolbox options listed in subsection 20.16.

20.13 Unfiltered system Cryptosporidium treatment requirements

20.13.1 Determination of mean Cryptosporidium level.

20.13.1.1 Following completion of the initial source water monitoring required under subsection 20.2.1, unfiltered systems must calculate the arithmetic mean of all Cryptosporidium sample concentrations reported under subsection 20.2.1. Systems must report this value to the Division for approval no later than 6 months after the month the system is required to complete initial source water monitoring based on the schedule in subsection 20.2.3.

20.13.1.2 Following completion of the second round of source water monitoring required under subsection 20.2.2, unfiltered systems must calculate the arithmetic mean of all Cryptosporidium sample concentrations reported under subsection 20.2.2. Systems must report this value to the Division for approval no later than 6 months after the month the system is required to complete the second round of source water monitoring based on the schedule in subsection 20.1.3.

20.13.1.3 If the monthly Cryptosporidium sampling frequency varies, systems must first calculate a monthly average for each month of monitoring. Systems must then use these monthly average concentrations, rather than individual sample concentrations, in the calculation of the mean Cryptosporidium level in subsections 20.13.1.1 or 20.13.1.2.

20.13.1.4 The report to the Division of the mean Cryptosporidium levels calculated under subsections 20.13.1.1 and 20.13.1.2 must include a summary of the source water monitoring data used for the calculation.

20.13.1.5 Failure to comply with the conditions of subsection 20.13.1 is a violation of the treatment technique requirement.

20.13.2 Cryptosporidium inactivation requirements. Unfiltered systems must provide the level of inactivation for Cryptosporidium specified in this paragraph, based on their mean Cryptosporidium levels as determined under subsection 20.13.1 and according to the schedule in subsection 20.14.

20.13.2.1 Unfiltered systems with a mean Cryptosporidium level of 0.01 oocysts/L or less must provide at least 2-log Cryptosporidium inactivation.

20.13.2.2 Unfiltered systems with a mean Cryptosporidium level of greater than 0.01 oocysts/L must provide at least 3-log Cryptosporidium inactivation.

20.13.3 Inactivation treatment technology requirements. Unfiltered systems must use chlorine dioxide, ozone, or UV as described in subsection 20.21 to meet the Cryptosporidium inactivation requirements of this section.

20.13.3.1 Systems that use chlorine dioxide or ozone and fail to achieve the Cryptosporidium inactivation required in subsection 20.13.2 on more than one day in the calendar month are in violation of the treatment technique requirement.

20.13.3.2 Systems that use UV light and fail to achieve the Cryptosporidium inactivation required in subsection 20.13.2 by meeting the criteria in subsection 20.21.4.2 are in violation of the treatment technique requirement.

20.13.4 Use of two disinfectants. Unfiltered systems must meet the combined Cryptosporidium inactivation requirements of this section and Giardia lamblia and virus inactivation requirements of section 16.3 using a minimum of two disinfectants, and each of two disinfectants must separately achieve the total inactivation required for either Cryptosporidium, Giardia lamblia, or viruses. Note: these regulations prohibit unfiltered surface water systems.

20.14 Schedule for compliance with Cryptosporidium treatment requirements

20.14.1 Following initial bin classification under subsection 20.11.3, filtered systems must provide the level of treatment for Cryptosporidium required under subsection 20.12 according to the schedule in subsection 20.14.3.

20.14.2 Following initial determination of the mean Cryptosporidium level under subsection 20.13.1.1, unfiltered systems must provide the level of treatment for Cryptosporidium required under subsection 20.13 according to the schedule in subsection 20.14.3.

20.14.3 Cryptosporidium treatment compliance dates.

Cryptosporidium Treatment Compliance Dates Table

20.14.4 If the bin classification for a filtered system changes following the second round of source water monitoring, as determined under subsection 20.11.4, the system must provide the level of treatment for Cryptosporidium required under subsection 20.12 on a schedule the Division approves.

20.14.5 If the mean Cryptosporidium level for an unfiltered system changes following the second round of monitoring, as determined under subsection 20.13.1.2, and if the system must provide a different level of Cryptosporidium treatment under subsection 20.13 due to this change, the system must meet this treatment requirement on a schedule the Division approves.

20.15 Requirements for uncovered finished water storage facilities

20.15.1 Systems using uncovered finished water storage facilities must comply with the conditions of this section.

20.15.2 Systems must notify the Division of the use of each uncovered finished water storage facility no later than April 1, 2008.

20.15.3 Systems must meet the conditions of subsections 20.15.3.1 or 20.15.3.2 for each uncovered finished water storage facility or be in compliance with a Division-approved schedule to meet these conditions no later than April 1, 2009.

20.15.3.1 Systems must cover any uncovered finished water storage facility.

20.15.3.2 Systems must treat the discharge from the uncovered finished water storage facility to the distribution system to achieve inactivation and/or removal of at least 4-log virus, 3-log Giardia lamblia, and 2-log Cryptosporidium using a protocol approved by the Division.

20.15.4 Failure to comply with the requirements of this section is a violation of the treatment technique requirement.

20.16 Microbial toolbox options for meeting Cryptosporidium treatment requirements.

20.16.1 Treatment credits

20.16.1.1 Systems receive the treatment credits listed in the table in subsection 20.16.2 by meeting the conditions for microbial toolbox options described in subsections 20.17 through 20.21. Systems apply these treatment credits to meet the treatment requirements in subsections 20.12 or 20.13, as applicable.

20.16.1.2 Unfiltered systems are eligible for treatment credits for the microbial toolbox options described in subsection 20.21 only.

20.16.2 The following table summarizes options, treatment credits, and criteria in the microbial toolbox:

Microbial Toolbox Summary Table: Options, Treatment Credits and Criteria

20.17 Source toolbox components

20.17.1 Watershed control program. Systems receive 0.5-log Cryptosporidium treatment credit for implementing a watershed control program that meets the requirements of this section.

20.17.1.1 Systems that intend to apply for the watershed control program credit must notify the Division of this intent no later than two years prior to the treatment compliance date applicable to the system in subsection 20.14.

20.17.1.2 Systems must submit to the Division a proposed watershed control plan no later than one year before the applicable treatment compliance date in subsection 20.14. The Division must approve the watershed control plan for the system to receive watershed control program treatment credit. The watershed control plan must include the elements in subsections 20.17.1.2.1 through 20.17.1.2.4.

20.17.1.2.1 Identification of an “area of influence” outside of which the likelihood of Cryptosporidium or fecal contamination affecting the treatment plant intake is not significant. This is the area to be evaluated in future watershed surveys under subsection 20.17.1.5.2.

20.17.1.2.2 Identification of both potential and actual sources of Cryptosporidium contamination and an assessment of the relative impact of these sources on the system's source water quality.

20.17.1.2.3 An analysis of the effectiveness and feasibility of control measures that could reduce Cryptosporidium loading from sources of contamination to the system's source water.

20.17.1.2.4 A statement of goals and specific actions the system will undertake to reduce source water Cryptosporidium levels. The plan must explain how the actions are expected to contribute to specific goals, identify watershed partners and their roles, identify resource requirements and commitments, and include a schedule for plan implementation with deadlines for completing specific actions identified in the plan.

20.17.1.3 Systems with existing watershed control programs (i.e., programs in place on January 5, 2006) are eligible to seek this credit. Their watershed control plans must meet the criteria in subsection 20.17.1.2 and must specify ongoing and future actions that will reduce source water Cryptosporidium levels.

20.17.1.4 If the Division does not respond to a system regarding approval of a watershed control plan submitted under this section and the system meets the other requirements of this section, the watershed control program will be considered approved and 0.5 log Cryptosporidium treatment credit will be awarded unless and until the Division subsequently withdraws such approval.

20.17.1.5 Systems must complete the actions in subsections 20.17.1.5.1 through 20.17.1.5.3 to maintain the 0.5-log credit.

20.17.1.5.1 Submit an annual watershed control program status report to the Division. The annual watershed control program status report must describe the system's implementation of the approved plan and assess the adequacy of the plan to meet its goals. It must explain how the system is addressing any shortcomings in plan implementation, including those previously identified by the Division or as the result of the watershed survey conducted under subsection 20.17.1.5.2. It must also describe any significant changes that have occurred in the watershed since the last watershed sanitary survey. If a system determines during implementation that making a significant change to its approved watershed control program is necessary, the system must notify the Division prior to making any such changes. If any change is likely to reduce the level of source water protection, the system must also list in its notification the actions the system will take to mitigate this effect.

20.17.1.5.2 Undergo a watershed sanitary survey every three years for community water systems and every five years for non-community water systems and submit the survey report to the Division. The survey must be conducted according to Division guidelines and by persons the Division approves.

20.17.1.5.2.1 The watershed sanitary survey must meet the following criteria: encompass the region identified in the Division-approved watershed control plan as the area of influence; assess the implementation of actions to reduce source water Cryptosporidium levels; and identify any significant new sources of Cryptosporidium.

20.17.1.5.2.2 If the Division determines that significant changes may have occurred in the watershed since the previous watershed sanitary survey, systems must undergo another watershed sanitary survey by a date the Division requires, which may be earlier than the regular date in subsection 20.17.1.5.2.

20.17.1.5.3 The system must make the watershed control plan, annual status reports, and watershed sanitary survey reports available to the public upon request. These documents must be in a plain language style and include criteria by which to evaluate the success of the program in achieving plan goals. The Division may approve systems to withhold from the public portions of the annual status report, watershed control plan, and watershed sanitary survey based on water supply security considerations.

20.17.1.6 If the Division determines that a system is not carrying out the approved watershed control plan, the Division may withdraw the watershed control program treatment credit.

20.17.2 Alternative source.

20.17.2.1 A system may conduct source water monitoring that reflects a different intake location (either in the same source or for an alternate source) or a different procedure for the timing or level of withdrawal from the source (alternative source monitoring). If the Division approves, a system may determine its bin classification under subsection 20.11 based on the alternative source monitoring results.

20.17.2.2 If systems conduct alternative source monitoring under subsection 20.17.2.1, systems must also monitor their current plant intake concurrently as described in subsection 20.2.

20.17.2.3 Alternative source monitoring under subsection 20.17.2.1 must meet the requirements for source monitoring to determine bin classification, as described in subsections 20.2 through 20.7. Systems must report the alternative source monitoring results to the Division, along with supporting information documenting the operating conditions under which the samples were collected.

20.17.2.4 If a system determines its bin classification under subsection 20.11 using alternative source monitoring results that reflect a different intake location or a different procedure for managing the timing or level of withdrawal from the source, the system must relocate the intake or permanently adopt the withdrawal procedure, as applicable, no later than the applicable treatment compliance date in subsection 20.14.

20.18 Pre-filtration treatment toolbox components

20.18.1 Presedimentation. Systems receive 0.5-log Cryptosporidium treatment credit for a presedimentation basin during any month the process meets the criteria in this paragraph.

20.18.1.1 The presedimentation basin must be in continuous operation and must treat the entire plant flow taken from a surface water or GWUDI source.

20.18.1.2 The system must continuously add a coagulant to the presedimentation basin.

20.18.1.3 The presedimentation basin must achieve the performance criteria in subsections 20.18.1.3.1 or 20.18.1.3.2.

20.18.1.3.1 Demonstrates at least 0.5-log mean reduction of influent turbidity. This reduction must be determined using daily turbidity measurements in the presedimentation process influent and effluent and must be calculated as follows: log10 (monthly mean of daily influent turbidity)-log10 (monthly mean of daily effluent turbidity).

20.18.1.3.2 Complies with Division-approved performance criteria that demonstrate at least 0.5-log mean removal of micron-sized particulate material through the presedimentation process.

20.18.2 Two-stage lime softening. Systems receive an additional 0.5-log Cryptosporidium treatment credit for a two-stage lime softening plant if chemical addition and hardness precipitation occur in two separate and sequential softening stages prior to filtration. Both softening stages must treat the entire plant flow taken from a surface water or GWUDI source.

20.18.3 Bank filtration. Systems receive Cryptosporidium treatment credit for bank filtration that serves as pretreatment to a filtration plant by meeting the criteria in this paragraph. Systems using bank filtration when they begin source water monitoring under subsection 20.2.1 must collect samples as described in subsection 20.4.4 and are not eligible for this credit.

20.18.3.1 Wells with a ground water flow path of at least 25 feet receive 0.5-log treatment credit; wells with a ground water flow path of at least 50 feet receive 1.0-log treatment credit. The ground water flow path must be determined as specified in subsection 20.18.3.4.

20.18.3.2 Only wells in granular aquifers are eligible for treatment credit. Granular aquifers are those comprised of sand, clay, silt, rock fragments, pebbles or larger particles, and minor cement. A system must characterize the aquifer at the well site to determine aquifer properties. Systems must extract a core from the aquifer and demonstrate that in at least 90 percent of the core length, grains less than 1.0 mm in diameter constitute at least 10 percent of the core material.

20.18.3.3 Only horizontal and vertical wells are eligible for treatment credit.

20.18.3.4 For vertical wells, the ground water flow path is the measured distance from the edge of the surface water body under high flow conditions (determined by the 100 year floodplain elevation boundary or by the floodway, as defined in Federal Emergency Management Agency flood hazard maps) to the well screen. For horizontal wells, the ground water flow path is the measured distance from the bed of the river under normal flow conditions to the closest horizontal well lateral screen.

20.18.3.5 Systems must monitor each wellhead for turbidity at least once every four hours while the bank filtration process is in operation. If monthly average turbidity levels, based on daily maximum values in the well, exceed 1 NTU, the system must report this result to the Division and conduct an assessment within 30 days to determine the cause of the high turbidity levels in the well. If the Division determines that microbial removal has been compromised, the Division may revoke treatment credit until the system implements corrective actions approved by the Division to remediate the problem.

20.18.3.6 Springs and infiltration galleries are not eligible for treatment credit under this subsection, but are eligible for credit under subsection 20.19.3.

20.18.3.7 Bank filtration demonstration of performance. The Division may approve Cryptosporidium treatment credit for bank filtration based on a demonstration of performance study that meets the criteria in this paragraph. This treatment credit may be greater than 1.0-log and may be awarded to bank filtration that does not meet the criteria in subsections 20.18.3.1 through 20.18.3.5.

20.18.3.7.1 The study must follow a Division-approved protocol and must involve the collection of data on the removal of Cryptosporidium or a surrogate for Cryptosporidium and related hydrogeologic and water quality parameters during the full range of operating conditions.

20.18.3.7.2 The study must include sampling both from the production well(s) and from monitoring wells that are screened and located along the shortest flow path between the surface water source and the production well(s).

20.19 Treatment performance toolbox components

20.19.1 Combined filter performance. Systems using conventional filtration treatment or direct filtration treatment receive an additional 0.5-log Cryptosporidium treatment credit during any month the system meets the criteria in this paragraph. Combined filter effluent (CFE) turbidity must be less than or equal to 0.15 NTU in at least 95 percent of the measurements. Turbidity must be measured as described in subsections 16.5.1.

20.19.2 Individual filter performance. Systems using conventional filtration treatment or direct filtration treatment receive 0.5-log Cryptosporidium treatment credit, which can be in addition to the 0.5-log credit under subsection 20.19.1, during any month the system meets the criteria in this paragraph. Compliance with these criteria must be based on individual filter turbidity monitoring as described in subsection 10.10 or 40 CFR section 141.560 (Copy available at the Office of Drinking Water as applicable).

20.19.2.1 The filtered water turbidity for each individual filter must be less than or equal to 0.15 NTU in at least 95 percent of the measurements recorded each month.

20.19.2.2 No individual filter may have a measured turbidity greater than 0.3 NTU in two consecutive measurements taken 15 minutes apart.

20.19.2.3 Any system that has received treatment credit for individual filter performance and fails to meet the requirements of subsections 20.19.2.1 or 20.19.2.2 during any month does not receive a treatment technique violation under subsection 20.12.3 if the Division determines the following:

20.19.2.3.1 The failure was due to unusual and short-term circumstances that could not reasonably be prevented through optimizing treatment plant design, operation, and maintenance.

20.19.2.3.2 The system has experienced no more than two such failures in any calendar year.

20.19.3 Demonstration of performance. The Division may approve Cryptosporidium treatment credit for drinking water treatment processes based on a demonstration of performance study that meets the criteria in this paragraph. This treatment credit may be greater than or less than the prescribed treatment credits in subsection 20.12 or subsections 20.18 through 20.21 and may be awarded to treatment processes that do not meet the criteria for the prescribed credits.

20.19.3.1 Systems cannot receive the prescribed treatment credit for any toolbox box option in subsections 20.18 through 20.21 if that toolbox option is included in a demonstration of performance study for which treatment credit is awarded under this paragraph.

20.19.3.2 The demonstration of performance study must follow a Division-approved protocol and must demonstrate the level of Cryptosporidium reduction the treatment process will achieve under the full range of expected operating conditions for the system.

20.19.3.3 Approval by the Division must be in writing and may include monitoring and treatment performance criteria that the system must demonstrate and report on an ongoing basis to remain eligible for the treatment credit. The Division may designate such criteria where necessary to verify that the conditions under which the demonstration of performance credit was approved are maintained during routine operation.

20.20 Additional filtration toolbox components

20.20.1 Bag and cartridge filters. Systems receive Cryptosporidium treatment credit of up to 2.0-log for individual bag or cartridge filters and up to 2.5-log for bag or cartridge filters operated in series by meeting the criteria in subsections 20.20.1.1 through 20.20.1.10. To be eligible for this credit, systems must report the results of challenge testing that meets the requirements of subsections 20.20.1.2 through 20.20.1.9 to the Division. The filters must treat the entire plant flow taken from a surface water or ground water under the direct influence of surface water source.

20.20.1.1 The Cryptosporidium treatment credit awarded to bag or cartridge filters must be based on the removal efficiency demonstrated during challenge testing that is conducted according to the criteria in subsections 20.20.1.2 through 20.20.1.9. A factor of safety equal to 1-log for individual bag or cartridge filters and 0.5-log for bag or cartridge filters in series must be applied to challenge testing results to determine removal credit. Systems may use results from challenge testing conducted prior to January 5, 2006 if the prior testing was consistent with the criteria specified in subsections 20.20.1.2 through 20.20.1.9.

20.20.1.2 Challenge testing must be performed on full-scale bag or cartridge filters, and the associated filter housing or pressure vessel, that are identical in material and construction to the filters and housings the system will use for removal of Cryptosporidium. Bag or cartridge filters must be challenge tested in the same configuration that the system will use, either as individual filters or as a series configuration of filters.

20.20.1.3 Challenge testing must be conducted using Cryptosporidium or a surrogate that is removed no more efficiently than Cryptosporidium. The microorganism or surrogate used during challenge testing is referred to as the challenge particulate. The concentration of the challenge particulate must be determined using a method capable of discreetly quantifying the specific microorganism or surrogate used in the test; gross measurements such as turbidity may not be used.

20.20.1.4 The maximum feed water concentration that can be used during a challenge test must be based on the detection limit of the challenge particulate in the filtrate (i.e., filtrate detection limit) and must be calculated using the following equation:

Maximum Feed Concentration = 1 x 104 x (Filtrate Detection Limit)

20.20.1.5 Challenge testing must be conducted at the maximum design flow rate for the filter as specified by the manufacturer.

20.20.1.6 Each filter evaluated must be tested for a duration sufficient to reach 100 percent of the terminal pressure drop, which establishes the maximum pressure drop under which the filter may be used to comply with the requirements of this section.

20.20.1.7 Removal efficiency of a filter must be determined from the results of the challenge test and expressed in terms of log removal values using the following equation:

LRV = LOG10 (Cf)-LOG10 (Cp)

Where:

LRV = log removal value demonstrated during challenge testing;

Cf = the feed concentration measured during the challenge test; and

Cp = the filtrate concentration measured during the challenge test.

20.20.1.7.1 In applying this equation, the same units must be used for the feed and filtrate concentrations. If the challenge particulate is not detected in the filtrate, then the term Cp must be set equal to the detection limit.

20.20.1.8 Each filter tested must be challenged with the challenge particulate during three periods over the filtration cycle: within two hours of start-up of a new filter; when the pressure drop is between 45 and 55 percent of the terminal pressure drop; and at the end of the cycle after the pressure drop has reached 100 percent of the terminal pressure drop. An LRV must be calculated for each of these challenge periods for each filter tested. The LRV for the filter (LRVfilter) must be assigned the value of the minimum LRV observed during the three challenge periods for that filter.

20.20.1.9 If fewer than 20 filters are tested, the overall removal efficiency for the filter product line must be set equal to the lowest LRVfilter among the filters tested. If 20 or more filters are tested, the overall removal efficiency for the filter product line must be set equal to the 10th percentile of the set of LRVfilter values for the various filters tested. The percentile is defined by (i/(n+1)) where i is the rank of an individual data points ordered lowest to highest. If necessary, the 10th percentile may be calculated using linear interpolation.

20.20.1.10 If a previously tested filter is modified in a manner that could change the removal efficiency of the filter product line, challenge testing to demonstrate the removal efficiency of the modified filter must be conducted and submitted to the Division.

20.20.2 Membrane filtration.

20.20.2.1 Systems receive Cryptosporidium treatment credit for membrane filtration that meets the criteria of this paragraph. Membrane cartridge filters that meet the definition of membrane filtration in Section 2.0 are eligible for this credit. The level of treatment credit a system receives is equal to the lower of the values determined under subsections 20.20.2.1.1 and 20.20.2.1.2.

20.20.2.1.1 The removal efficiency demonstrated during challenge testing conducted under the conditions in subsection 20.20.2.2.

20.20.2.1.2 The maximum removal efficiency that can be verified through direct integrity testing used with the membrane filtration process under the conditions in subsection 20.20.2.3.

20.20.2.2 Challenge Testing. The membrane used by the system must undergo challenge testing to evaluate removal efficiency, and the system must report the results of challenge testing to the Division. Challenge testing must be conducted according to the criteria in subsections 20.20.2.2.1 through 20.20.2.2.7. Systems may use data from challenge testing conducted prior to January 5, 2006 if the prior testing was consistent with the criteria in subsections 20.20.2.2.1 through 20.20.2.2.7.

20.20.2.2.1 Challenge testing must be conducted on either a full-scale membrane module, identical in material and construction to the membrane modules used in the system's treatment facility, or a smaller-scale membrane module, identical in material and similar in construction to the full-scale module. A module is defined as the smallest component of a membrane unit in which a specific membrane surface area is housed in a device with a filtrate outlet structure.

20.20.2.2.2 Challenge testing must be conducted using Cryptosporidium oocysts or a surrogate that is removed no more efficiently than Cryptosporidium oocysts. The organism or surrogate used during challenge testing is referred to as the challenge particulate. The concentration of the challenge particulate, in both the feed and filtrate water, must be determined using a method capable of discretely quantifying the specific challenge particulate used in the test; gross measurements such as turbidity may not be used.

20.20.2.2.3 The maximum feed water concentration that can be used during a challenge test is based on the detection limit of the challenge particulate in the filtrate and must be determined according to the following equation:

Maximum Feed Concentration = 3.16 x 106 x (Filtrate Detection Limit)

20.20.2.2.4 Challenge testing must be conducted under representative hydraulic conditions at the maximum design flux and maximum design process recovery specified by the manufacturer for the membrane module. Flux is defined as the throughput of a pressure driven membrane process expressed as flow per unit of membrane area. Recovery is defined as the volumetric percent of feed water that is converted to filtrate over the course of an operating cycle uninterrupted by events such as chemical cleaning or a solids removal process (i.e., backwashing).

20.20.2.2.5 Removal efficiency of a membrane module must be calculated from the challenge test results and expressed as a log removal value according to the following equation:

LRV = LOG10(Cf) - LOG10(Cp)

Where:

LRV = log removal value demonstrated during the challenge test;

Cf = the feed concentration measured during the challenge test; and

Cp = the filtrate concentration measured during the challenge test.

Equivalent units must be used for the feed and filtrate concentrations. If the challenge particulate is not detected in the filtrate, the term Cp is set equal to the detection limit for the purpose of calculating the LRV. An LRV must be calculated for each membrane module evaluated during the challenge test.

20.20.2.2.6 The removal efficiency of a membrane filtration process demonstrated during challenge testing must be expressed as a log removal value (LRVC-Test). If fewer than 20 modules are tested, then LRVC-Test is equal to the lowest of the representative LRVs among the modules tested. If 20 or more modules are tested, then LRVC-Test is equal to the 10th percentile of the representative LRVs among the modules tested. The percentile is defined by (i/(n+1)) where i is the rank of n individual data points ordered lowest to highest. If necessary, the 10th percentile may be calculated using linear interpolation.

20.20.2.2.7 The challenge test must establish a quality control release value (QCRV) for a non-destructive performance test that demonstrates the Cryptosporidium removal capability of the membrane filtration module. This performance test must be applied to each production membrane module used by the system that was not directly challenge tested in order to verify Cryptosporidium removal capability. Production modules that do not meet the established QCRV are not eligible for the treatment credit demonstrated during the challenge test.

20.20.2.2.8 If a previously tested membrane is modified in a manner that could change the removal efficiency of the membrane or the applicability of the non-destructive performance test and associated QCRV, additional challenge testing to demonstrate the removal efficiency of, and determine a new QCRV for, the modified membrane must be conducted and submitted to the Division.

20.20.2.3 Direct integrity testing. Systems must conduct direct integrity testing in a manner that demonstrates a removal efficiency equal to or greater than the removal credit awarded to the membrane filtration process and meets the requirements described in subsections 20.20.2.3.1 through 20.20.2.3.6. A direct integrity test is defined as a physical test applied to a membrane unit in order to identify and isolate integrity breaches (i.e., one or more leaks that could result in contamination of the filtrate).

20.20.2.3.1 The direct integrity test must be independently applied to each membrane unit in service. A membrane unit is defined as a group of membrane modules that share common valving that allows the unit to be isolated from the rest of the system for the purpose of integrity testing or other maintenance.

20.20.2.3.2 The direct integrity method must have a resolution of 3 micrometers or less, where resolution is defined as the size of the smallest integrity breach that contributes to a response from the direct integrity test.

20.20.2.3.3 The direct integrity test must have a sensitivity sufficient to verify the log treatment credit awarded to the membrane filtration process by the Division, where sensitivity is defined as the maximum log removal value that can be reliably verified by a direct integrity test. Sensitivity must be determined using the approach in either subsection 20.20.2.3.3.1 or 20.20.2.3.3.2 as applicable to the type of direct integrity test the system uses.

20.20.2.3.3.1 For direct integrity tests that use an applied pressure or vacuum, the direct integrity test sensitivity must be calculated according to the following equation:

LRVDIT = LOG10 (Qp/(VCF x Qbreach))

Where:

LRVDIT = the sensitivity of the direct integrity test;

Qp = total design filtrate flow from the membrane unit;

Qbreach = flow of water from an integrity breach associated with the smallest integrity test response that can be reliably measured, and

VCF = volumetric concentration factor. The volumetric concentration factor is the ratio of the suspended solids concentration on the high pressure side of the membrane relative to that in the feed water.

20.20.2.3.3.2 For direct integrity tests that use a particulate or molecular marker, the direct integrity test sensitivity must be calculated according to the following equation:

LRVDIT = LOG10 (Cf)- LOG10(Cp)

Where:

LRVDIT = the sensitivity of the direct integrity test;

Cf = the typical feed concentration of the marker used in the test; and Cp = the filtrate concentration of the marker from an integral membrane unit.

20.20.2.3.4 Systems must establish a control limit within the sensitivity limits of the direct integrity test that is indicative of an integral membrane unit capable of meeting the removal credit awarded by the Division.

20.20.2.3.5 If the result of a direct integrity test exceeds the control limit established under subsection 20.20.2.3.4, the system must remove the membrane unit from service. Systems must conduct a direct integrity test to verify any repairs, and may return the membrane unit to service only if the direct integrity test is within the established control limit.

20.20.2.3.6 Systems must conduct direct integrity testing on each membrane unit at a frequency of not less than once each day that the membrane unit is in operation. The Division may approve less frequent testing, based on demonstrated process reliability, the use of multiple barriers effective for Cryptosporidium, or reliable process safeguards.

20.20.2.4 Indirect integrity monitoring. Systems must conduct continuous indirect integrity monitoring on each membrane unit according to the criteria in subsections 20.20.2.4.1 through 20.20.2.4.5. Indirect integrity monitoring is defined as monitoring some aspect of filtrate water quality that is indicative of the removal of particulate matter. A system that implements continuous direct integrity testing of membrane units in accordance with the criteria in subsections 20.20.2.3.1 through 20.20.2.3.5 is not subject to the requirements for continuous indirect integrity monitoring. Systems must submit a monthly report to the Division summarizing all continuous indirect integrity monitoring results triggering direct integrity testing and the corrective action that was taken in each case.

20.20.2.4.1 Unless the Division approves an alternative parameter, continuous indirect integrity monitoring must include continuous filtrate turbidity monitoring.

20.20.2.4.2 Continuous monitoring must be conducted at a frequency of no less than once every 15 minutes.

20.20.2.4.3 Continuous monitoring must be separately conducted on each membrane unit.

20.20.2.4.4 If indirect integrity monitoring includes turbidity and if the filtrate turbidity readings are above 0.15 NTU for a period greater than 15 minutes (i.e., two consecutive 15-minute readings above 0.15 NTU), direct integrity testing must immediately be performed on the associated membrane unit as specified in subsections 20.20.2.3.1 through 20.20.2.3.5.

20.20.2.4.5 If indirect integrity monitoring includes a Division-approved alternative parameter and if the alternative parameter exceeds a Division-approved control limit for a period greater than 15 minutes, direct integrity testing must immediately be performed on the associated membrane units as specified in subsections 20.20.2.3.1 through 20.20.2.3.5.

20.20.3 Second stage filtration. Systems receive 0.5-log Cryptosporidium treatment credit for a separate second stage of filtration that consists of sand, dual media, GAC, or other fine grain media following granular media filtration if the Division approves. To be eligible for this credit, the first stage of filtration must be preceded by a coagulation step and both filtration stages must treat the entire plant flow taken from a surface water or GWUDI source. A cap, such as GAC, on a single stage of filtration is not eligible for this credit. The Division must approve the treatment credit based on an assessment of the design characteristics of the filtration process.

20.20.4 Slow sand filtration (as secondary filter). Systems are eligible to receive 2.5-log Cryptosporidium treatment credit for a slow sand filtration process that follows a separate stage of filtration if both filtration stages treat entire plant flow taken from a surface water or GWUDI source and no disinfectant residual is present in the influent water to the slow sand filtration process. The Division must approve the treatment credit based on an assessment of the design characteristics of the filtration process. This paragraph does not apply to treatment credit awarded to slow sand filtration used as a primary filtration process.

20.21 Inactivation toolbox components

20.21.1 Calculation of CT values.

20.21.1.1 CT is the product of the disinfectant contact time (T, in minutes) and disinfectant concentration (C, in milligrams per liter). Systems with treatment credit for chlorine dioxide or ozone under subsection 20.21.2 or 20.21.3 must calculate CT at least once each day, with both C and T measured during peak hourly flow as specified in subsection 10.6.

20.21.1.2 Systems with several disinfection segments in sequence may calculate CT for each segment, where a disinfection segment is defined as a treatment unit process with a measurable disinfectant residual level and a liquid volume. Under this approach, systems must add the Cryptosporidium CT values in each segment to determine the total CT for the treatment plant.

20.21.2 CT values for chlorine dioxide and ozone.

20.21.2.1 Systems receive the Cryptosporidium treatment credit listed in this table by meeting the corresponding chlorine dioxide CT value for the applicable water temperature, as described in subsection 20.21.1.

CT Values (mg-min/L) for Cryptosporidium Inactivation by Chlorine Dioxide 1

20.21.2.2 Systems receive the Cryptosporidium treatment credit listed in this table by meeting the corresponding ozone CT values for the applicable water temperature, as described in subsection 20.21.1.

CT Values (mg-min/L) for Cryptosporidium Inactivation by Ozone1

20.21.3 Site-specific study. The Division may approve alternative chlorine dioxide or ozone CT values to those listed in subsection 20.21.2 on a site-specific basis. The Division must base this approval on a site-specific study a system conducts that follows a Division-approved protocol.

20.21.4 Ultraviolet light. Systems receive Cryptosporidium, Giardia lamblia, and virus treatment credits for ultraviolet (UV) light reactors by achieving the corresponding UV dose values shown in subsection 20.21.4.1. Systems must validate and monitor UV reactors as described in subsections 20.21.4.2 and 20.21.4.3 to demonstrate that they are achieving a particular UV dose value for treatment credit.

20.21.4.1 UV dose table. The treatment credits listed in this table are for UV light at a wavelength of 254 nm as produced by a low pressure mercury vapor lamp. To receive treatment credit for other lamp types, systems must demonstrate an equivalent germicidal dose through reactor validation testing, as described in subsection 20.21.4.2. The UV dose values in this table are applicable only to post-filter applications of UV in filtered systems and to unfiltered systems.

UV Dose Table for Cryptosporidium, Giardia lamblia, and Virus Inactivation Credit

20.21.4.2 Reactor validation testing. Systems must use UV reactors that have undergone validation testing to determine the operating conditions under which the reactor delivers the UV dose required in subsection 20.21.4.1 (i.e., validated operating conditions). These operating conditions must include flow rate, UV intensity as measured by a UV sensor, and UV lamp status.

20.21.4.2.1 When determining validated operating conditions, systems must account for the following factors: UV absorbance of the water; lamp fouling and aging; measurement uncertainty of on-line sensors; UV dose distributions arising from the velocity profiles through the reactor; failure of UV lamps or other critical system components; and inlet and outlet piping or channel configurations of the UV reactor.

20.21.4.2.2 Validation testing must include the following: Full scale testing of a reactor that conforms uniformly to the UV reactors used by the system and inactivation of a test microorganism whose dose response characteristics have been quantified with a low-pressure mercury vapor lamp.

20.21.4.2.3 The Division may approve an alternative approach to validation testing.

20.21.4.3 Reactor monitoring.

20.21.4.3.1 Systems must monitor their UV reactors to determine if the reactors are operating within validated conditions, as determined under subsection 20.21.4.2. This monitoring must include UV intensity as measured by a UV sensor, flow rate, lamp status, and other parameters the Division designates based on UV reactor operation. Systems must verify the calibration of UV sensors and must recalibrate sensors in accordance with a protocol the Division approves.

20.21.4.3.2 To receive treatment credit for UV light, systems must treat at least 95 percent of the water delivered to the public during each month by UV reactors operating within validated conditions for the required UV dose, as described in subsections 20.21.4.1 and 20.21.4.2 of this section. Systems must demonstrate compliance with this condition by the monitoring required under subsection 20.21.4.3.1.

20.22 Reporting requirements

20.22.1 Systems must report sampling schedules under subsection 20.3 and source water monitoring results under subsection 20.7 unless they notify the Division that they will not conduct source water monitoring due to meeting the criteria of subsection 20.2.4.

20.22.2 Systems must report the use of uncovered finished water storage facilities to the Division as described in subsection 20.15.

20.22.3 Filtered systems must report their Cryptosporidium bin classification as described in subsection 20.11.

20.22.4 Unfiltered systems must report their mean source water Cryptosporidium level as described in subsection 20.13.

20.22.5 Systems must report disinfection profiles and benchmarks to the Division as described in subsections 20.9 through 20.10 prior to making a significant change in disinfection practice.

20.22.6 Systems must report to the Division in accordance with the following table for any microbial toolbox options used to comply with treatment requirements under subsections 20.12 or 20.13.

20.22.6.1 Alternatively, the Division may approve a system to certify operation within required parameters for treatment credit rather than reporting monthly operational data for toolbox options.

Microbial Toolbox Reporting Requirements

20.23 Recordkeeping requirements

20.23.1 Systems must keep results from the initial round of source water monitoring under subsection 20.2.1 and the second round of source water monitoring under subsection 20.2.2 until 3 years after bin classification under subsection 20.11 for filtered systems or determination of the mean Cryptosporidium level under subsection 20.11 for unfiltered systems for the particular round of monitoring.

20.23.2 Systems must keep any notification to the Division that they will not conduct source water monitoring due to meeting the criteria of subsection 20.2.4 for 3 years.

20.23.3 Systems must keep the results of treatment monitoring associated with microbial toolbox options under subsections 20.17 through 20.21 and with uncovered finished water reservoirs under subsection 20.15, as applicable, for 3 years.

20.24 Requirements to respond to significant deficiencies identified in sanitary surveys performed by the Division.

20.24.1 A sanitary survey is an onsite review of the water source (identifying sources of contamination by using results of source water assessments where available), facilities, equipment, operation, maintenance, and monitoring compliance of a PWS to evaluate the adequacy of the PWS, its sources and operations, and the distribution of safe drinking water.

20.24.2 For the purposes of this section, a significant deficiency includes a defect in design, operation, or maintenance, or a failure or malfunction of the sources, treatment, storage, or distribution system that the Division determines to be causing, or has the potential for causing the introduction of contamination into the water delivered to consumers.

20.24.3 For sanitary surveys performed by the Division, systems must respond in writing to significant deficiencies identified in sanitary survey reports no later than 45 days after receipt of the report, indicating how and on what schedule the system will address significant deficiencies noted in the survey.

20.24.4 Systems must correct significant deficiencies identified in sanitary survey reports according to the schedule approved by the Division, or if there is no approved schedule, according to the schedule reported under subsection 20.24.3 if such deficiencies are within the control of the system.

**History**
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *25 DE Reg. 713 (01/01/22)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *5 DE Reg. 2121 (05/01/02)*
- *9 DE Reg. 999 (12/01/05)*
- *15 DE Reg. 73 (07/01/12)*
- *17 DE Reg. 439 (10/01/13)*
- *19 DE Reg. 517 (12/01/15)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *25 DE Reg. 713 (01/01/22)*

##### **16 Del. Admin. Code § 4462-21.0** Cross-Connection Control {#sec-4462-21.0 omnilex-key=us-de-regs-official--title-16--4462-21.0}

21.1 Cross-connection control requirements and prohibitions.

21.1.1 No public water system shall install or maintain a water service connection to any premises where actual or potential cross-connections to a public water system exist unless such actual or potential cross-connections are eliminated or controlled to the satisfaction of the owner of the public water system and the Division.

21.1.2 No public water system shall install or maintain any connection whereby water from an auxiliary water system may enter a public water system unless the auxiliary water supply and the method of connection and use of such system has been approved by the owner of the public water system and the Division.

21.1.3 In accordance with subsection 1.12.1.4, public water systems shall maintain acceptable water pressure throughout the distribution system so that the risk of backflow is reduced.

21.1.4 If a cross-connection exists or backflow occurs at a consumer's water system, the public water system may discontinue service to the consumer and water service shall not be restored until the deficiencies have been corrected.

21.2 Cross-connection control programs.

21.2.1 A public water system shall develop a plan for a comprehensive cross-connection control program for the elimination, prevention, and control of cross-connections appropriate to the number of service connections, size of the distribution system, and type of customers. The cross-connection control program shall include an individual designated by the public water system and appropriately trained and experienced in cross-connection control programs to be responsible for the program.

21.2.2 A cross-connection control program shall include an inventory and records of testing, repairs, and maintenance of all backflow prevention assemblies, and backflow elimination methods.

21.2.3 A cross-connection control program shall include appropriate policies to complete assessments of customer premises for potential cross-connections, to establish hazard criteria to classify customer premises consistent with Table 1, and to determine the degree of hazard and adequacy of existing preventive measures.

21.2.4 An approved backflow prevention assembly or backflow elimination method shall be installed at premises where the following conditions exist in a location intended to prevent backflow into the distribution system:

21.2.4.1 Premises having an auxiliary water system;

21.2.4.2 Premises types that are deemed by the public water system or the Division to represent a health or high hazard to the public water system, to include but not be limited to:

21.2.4.3 Premises having internal cross-connections that, in the judgment of the public water system, are not correctable or are impractical to determine if cross-connections exist due to intricate plumbing arrangements;

21.2.4.4 Premises where because of security requirements or other prohibitions, it is impossible to complete a cross-connection control survey; or

21.2.4.5 Premises having a history of cross-connections being established or reestablished.

21.2.5 In lieu of assessments and installation of backflow prevention assemblies at customer premises deemed low hazard, a public water system may implement a public education program.

21.2.5.1 The public education program shall include, at minimum:

21.2.5.1.1 Causes and dangers of backflow and cross-connections, including health effects;

21.2.5.1.2 Information on how to identify actual and potential cross-connections;

21.2.5.1.3 Preventive measures to reduce or eliminate cross-connection and backflow risks; and

21.2.5.1.4 Information on reporting suspected cross-connections to the public water system.

21.3 Corrections and protective devices.

21.3.1 Backflow prevention assemblies shall conform to the standards of the American Society of Sanitary Engineering (ASSE), the American Water Works Association (AWWA), and the American Society of Mechanical Engineers (ASME).

21.4 Cross-connection control records and reporting.

21.4.1 All backflow prevention assembly test records which document the test results of assemblies designed to protect the public water system shall be retained on file for a period of no less than 10 years.

21.4.2 All cross-connection control survey records which document results from the monitoring of cross-connections shall be retained on file for a period of no less than 10 years.

21.5 Violations.

21.5.1 The following items shall be deemed to be violations of these regulations:

21.5.1.1 Failure to develop and implement a comprehensive cross-connection control program in accordance with subsection 21.2 of this regulation within three years of the effective date of these regulations;

21.5.1.2 Failure to implement the cross-connection control program as prescribed; and

21.5.1.3 Failure to maintain all backflow prevention assembly test records on file for at least 10 years.

21.6 Penalty Clause. Any person who neglects or fails to comply with these regulations shall be subject to penalty as provided in 16 Del.C. §122(3)c.

**History**
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *25 DE Reg. 713 (01/01/22)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *24 DE Reg. 794 (02/01/21)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *5 DE Reg. 2121 (05/01/02)*
- *9 DE Reg. 999 (12/01/05)*
- *15 DE Reg. 73 (07/01/12)*
- *17 DE Reg. 439 (10/01/13)*
- *19 DE Reg. 517 (12/01/15)*
- *20 DE Reg. 555 (01/01/17)*
- *20 DE Reg. 808 (04/01/17)*
- *24 DE Reg. 794 (02/01/21)*
- *25 DE Reg. 713 (01/01/22)*

#### **4463** Licensing and Registration of Operators of Public Water Supply Systems

##### **16 Del. Admin. Code § 4463-1.0** Purpose {#sec-4463-1.0 omnilex-key=us-de-regs-official--title-16--4463-1.0}

These regulations protect the public health and provide for the development and protection of the potable water-supply systems of this State, provide for the classification of public water systems, require the licensing of operators of these systems, provide procedures for licensing and registration, and impose penalties for violations.

**History**
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *8 DE Reg. 453 (09/01/04)*
- *17 DE Reg. 924 (03/01/14)*
- *23 DE Reg. 928 (05/01/20)*

##### **16 Del. Admin. Code § 4463-2.0** Definitions {#sec-4463-2.0 omnilex-key=us-de-regs-official--title-16--4463-2.0}

“Acceptable operating experience” means active, on-site leadership in the operation of a treatment plant/distribution system of a public water supply system.

“Advisory Council” means Advisory Council for Certification of Public Water System Operators, as established by this regulation.

“Base-level License” means a water treatment and distribution license that covers general water system information, disinfection by hypochlorination, and distribution operation and maintenance for water supply systems having a flow of less than five hundred (500) gpm at twenty (20) psi.

“Circuit rider/contract operator” means a certified water operator who serves as the direct responsible charge (DRC) for two or more public water systems under separate ownership.

“Combined treatment/distribution system” means any water supply system composed of a water treatment facility together with a water distribution system as defined in this section.

“Continuing education unit” or “CEU” means a measure of professional, educational training, where one CEU is equal to 10 educational contact hours of classroom or laboratory training.

“Department” shall mean the Delaware Department of Health and Social Services.

“Direct responsible charge” or “DRC” means (1) a certified water system operator assigned active, daily, technical direction and supervision or (2) active, daily, accountability for process control decisions of a facility/major segment of a facility that directly impacts public health or the environment. An operator must be fully licensed for one full year before designation as a DRC.

“Director” means Director of the Division of Public Health or the Director’s duly authorized designee.

“Distribution system” means a network of pipes, valves, fire hydrants, service lines, meters, storage tanks, finished water reservoirs and pumping stations. The system delivers water to homes, businesses, and industries for drinking water and other uses.

“Division” means the Division of Public Health.

“Educational contact hour” means the amount of time spent at an approved water operator or water distribution operator training course during the licensing period. One hour of time spent in a training course is equal to one educational contact hour. This does not include travel time or lodging time. For the purpose of these regulations, the initial base certification course does not qualify as educational contact hours.

“Endorsement” means any water treatment operation listed in subsection 5.2.1 over and above the base-level license.

“gpm” means gallons per minute.

“Hands-on” means the applicant operates a water treatment plant or distribution system and has performed other tasks including but not limited to routine tests, collection of samples, and completion of operational reports. The knowledge possessed was gathered, in part, from daily operating experience, not merely from textbook study.

“Leadership” means activities such as treatment plant startup and hands-on operator training.

“Licensing Period” means the fixed two-year period beginning on the first day of the month after the initial license issue date and ending on the last day of the 24th month thereafter.

“Operator” means the individual who has responsibility for the operation of a water treatment plant or water distribution system and any individual who normally has charge of an operating shift, or who performs process control decisions including analytical control.

“Person” means corporations, companies, associations, firms, municipally-owned water utilities, partnerships, societies and joint stock companies, as well as individuals.

“Process control decision” means a decision that maintains or changes the water quality or quantity of a water system in a manner that may affect the public health or the environment.

“psi” means pounds per square inch.

“Public water system” means a water supply system for the provision to the public of water for human consumption through pipes or other constructed conveyances either directly from the user's free-flowing outlet or indirectly by the water being used to manufacture ice, foods and beverages or that supplies water for potable or domestic purposes to employees, tenants, members, guests or the public at large in commercial offices, industrial areas, multiple dwellings or semi-public buildings including, but without limitation, rooming and boarding houses, motels, tourist cabins, mobile home parks, restaurants, hospitals and other institutions, or offers any water for sale for potable domestic purposes. A dwelling unit means one or more rooms arranged for the use of one or more individuals as a single housekeeping unit, with cooking, living, sanitary and sleeping facilities. Public water systems are classified as follows:

“Secretary” means the Administrator of the Department of Health and Social Services of the State of Delaware as defined in 29 Del.C. §7902(a) or the Director’s duly authorized designee.

“Water distribution system” means the pumps, piping, and storage facilities from the source/treatment plant to the property line of the ultimate consumer.

“Water supplier” means any person who owns, operates, or manages a public water system.

“Water supply system” means the work and auxiliaries for collection, treatment, storage, or distribution of water from the source of supply to the free-flowing outlet of the ultimate consumer.

“Water treatment” or “treatment” means any process that is meant to alter the physical, chemical or bacteriological quality of the water.

“Water treatment facility” means that portion of the water supply system that is meant to alter the physical, chemical, or bacteriological quality of the water being treated.

**History**
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *8 DE Reg. 453 (09/01/04)*
- *17 DE Reg. 924 (03/01/14)*
- *23 DE Reg. 928 (05/01/20)*

##### **16 Del. Admin. Code § 4463-3.0** Advisory Council for Certification Of Public Water System Operators {#sec-4463-3.0 omnilex-key=us-de-regs-official--title-16--4463-3.0}

3.1 An Advisory Council for Certification of Public Water System Operators shall be appointed by the Secretary to advise and assist in the administration of these regulations.

3.2 Membership

3.2.1 The Advisory Council shall consist of a minimum of seven members. Membership shall consist of:

3.2.1.1 One representative from the Division of Public Health who shall serve as Secretary/Treasurer, responsible for maintaining all appropriate records and conducting the daily business of the Advisory Council;

3.2.1.2 One representative of the public-at-large;

3.2.1.3 Two representatives of local government agencies with managerial responsibility for water treatment or water distribution in a public water system with the following representation:

3.2.1.3.1 One representative of a local government agency having a population greater than or equal to 10,001; and

3.2.1.3.2 One representative of a local government agency having a population less than or equal to 10,000;

3.2.1.4 One representative of business or industry;

3.2.1.5 One representative of a public water utility; and

3.2.1.6 One representative holding a valid water operator's license, or who is eligible to be licensed under these regulations.

3.2.2 Advisory Council members shall serve a five-year term or until such time as a re-appointment or a replacement appointment is made. Members shall have the right to resign at their request.

3.2.2.1 The Division representative will serve an unlimited term at the discretion of the Secretary.

3.2.3 Advisory Council appointees shall represent all counties of the State, with at least one member each representing New Castle, Kent, and Sussex Counties.

3.2.4 The Advisory Council shall elect a Chair from among the members.

3.2.5 The Secretary may remove any member of the Advisory Council for misconduct, incapacity, or neglect of duty, and shall be the sole judge of the justification for removal.

3.2.6 The Secretary shall fill any vacancy. Such an interim appointment shall be for the duration of the term.

3.3 The Advisory Council shall hold at least four meetings each calendar year and such special meetings as it deems necessary.

3.3.1 A majority of the Advisory Council membership in attendance at any meeting shall constitute a quorum of the Advisory Council.

3.4 Responsibility and Authority

3.4.1 The Advisory Council, with the consent of the Secretary, shall establish such procedures and guidelines as may be necessary for the administration of this regulation. These procedures and guidelines shall include but not be limited to the following:

3.4.1.1 Procedures for examination of applicants and the granting of licenses;

3.4.1.2 Procedures for the renewal of licenses;

3.4.1.3 Procedures for the suspension, revocation, and failure to renew licenses;

3.4.1.4 Guidelines for evaluating equivalency of training and examinations conducted by recognized agencies and institutions;

3.4.1.5 Guidelines for evaluating equivalency of other licensing and certification programs for the purpose of according reciprocal treatment; and

3.4.1.6 Procedures for the collection and disbursement of fees.

3.4.2 The Advisory Council shall possess the necessary authority as delegated by the Secretary to carry out all activities required for the proper administration of these regulations. Such authority includes:

3.4.2.1 The development of rules and regulations, to be adopted by the Secretary, concerning the licensing of operators of public water systems;

3.4.2.2 Establishing the method of examination for each license applicant, including preparation, administration, and grading of examinations;

3.4.2.3 The recommendation to the Secretary regarding the issuance and renewal of licenses; and

3.4.2.4 The recommendation of disciplinary sanctions to the Secretary on operators who violate Section 11.0 of these regulations.

**History**
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *8 DE Reg. 453 (09/01/04)*
- *17 DE Reg. 924 (03/01/14)*
- *23 DE Reg. 928 (05/01/20)*

##### **16 Del. Admin. Code § 4463-4.0** License Requirements for Public Water Systems {#sec-4463-4.0 omnilex-key=us-de-regs-official--title-16--4463-4.0}

4.1 Water Supply Treatment Operators. A public water system treatment facility must be under the operation of a DRC.

4.2 Water Supply Treatment Facility Operators. It shall be a violation of these regulations for any person to be a DRC or operate any public water system treatment facility unless they possess a valid base-level license and applicable endorsements, if any, for the treatment facility to be operated.

4.3 Water Supply Distribution Systems. A public water distribution system, capable of producing greater than 500 gpm at 20 psi must be under the operation of a DRC possessing, at a minimum, a distribution endorsement.

4.4 Water Supply Distribution System Operators. It shall be a violation of these regulations for any person to be a DRC or operate any public water distribution system capable of producing greater than 500 gpm at 20 psi unless they possess a valid base-level license and, at a minimum, a distribution endorsement.

4.5 Combined Treatment/Distribution Supply Systems

4.5.1 The license requirements stipulated in subsections 4.1 and 4.3 apply separately and equally to the water supply treatment facility operator and the water supply distribution facility operator of a combined treatment/distribution supply system.

4.5.2 A water supply treatment facility that is part of a combined public water treatment/distribution system must be operated by a DRC.

4.5.3 A water supply distribution system that is part of a combined public water treatment/distribution system capable of producing greater than 500 gpm at 20 psi, must be under the DRC of a person possessing a valid base-level license and, at a minimum, a distribution endorsement.

4.5.4 The requirement of a distribution endorsement as stated in subsection 4.5.3 may be waived if the owner demonstrates to the Division that the operation and maintenance of the water system is contracted out to another licensed operator.

4.6 An owner of a public water system treatment facility, distribution system, or combined treatment/distribution system must provide the Division a list of all persons in DRC and all operators who have been duly licensed under these regulations.

4.6.1 The owner must notify the Division, in writing, of any addition, deletion, or other change in the number of licensed DRCs by the close of business the next business day after such change. The notification must include the name and license number of the new DRC.

4.7 Temporary Variance

4.7.1 The Secretary may grant a temporary variance from the license requirements listed in subsections 4.1, 4.3 and 4.5 of this regulation, upon recommendation by the Advisory Council, to the owner of a public water system treatment facility, distribution system, or combined treatment/distribution system, when it is demonstrated to the satisfaction of the Advisory Council that the owner has unexpectedly lost a licensed operator and is unable to hire a licensed operator in spite of good faith efforts. The temporary variance may be issued with any special conditions or requirements deemed necessary to assure the protection of the public health.

4.7.1.1 Owner must notify the Division of the unexpected loss of a licensed operator within 30 days pursuant to subsection 4.6.

4.7.1.2 Owner must apply for the temporary variance no later than 30 days after loss of an operator.

4.7.1.3 The Secretary shall notify the applicant in writing of the decision to approve or deny the temporary variance once the Advisory Council reviews the application and any other pertinent materials and makes a recommendation to the Secretary.

4.7.2 A temporary variance shall be valid only for that facility or system for which it is issued and for a period of time as specified by the Secretary, not to exceed six months.

4.7.3 The Secretary may extend a temporary variance when the owner demonstrates the owner has continued to act in good faith in attempting to hire a licensed operator but is unable to do so.

4.7.3.1 The Secretary may grant one extension of the original variance, upon recommendation by the Advisory Council, for a period of time not to exceed six months.

4.7.3.2 Owners must request an extension of a temporary variance to the Advisory Council in writing no later than one month prior to the expiration of the original variance.

**History**
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *8 DE Reg. 453 (09/01/04)*
- *17 DE Reg. 924 (03/01/14)*
- *23 DE Reg. 928 (05/01/20)*

##### **16 Del. Admin. Code § 4463-5.0** Classification of Public Water Systems {#sec-4463-5.0 omnilex-key=us-de-regs-official--title-16--4463-5.0}

5.1 The Division shall classify all public water systems in accordance with the criteria hereby established.

5.2 Water Supply Facilities

5.2.1 Public water system supply facilities shall be classified according to the treatment processes they operate. General treatment processes shall be grouped into categories hereby called endorsements. Specific unit processes within each endorsement shall be called endorsement sub-categories. A list of the endorsements and endorsement sub-categories is attached hereto as Appendix A.

5.2.2 Public water systems shall have, at minimum, a DRC who has obtained the endorsements and endorsement sub-categories consistent with treatment and distribution processes utilized by the water system. The endorsements are as follows:

5.2.2.1 Disinfection;

5.2.2.2 Chemical feed;

5.2.2.3 Filtration;

5.2.2.4 Surface water operations;

5.2.2.5 Other specified treatment;

5.2.2.6 Distribution; and

5.2.2.7 Approved sampler/tester.

5.2.3 Appendix A may be amended depending on industry changes in treatment technologies.

5.2.4 In the event of an emergency, for which a treatment process is required to provide immediate public health protection and for which the DRC or operator is currently not licensed, the Division may grant approval to add an emergency endorsement to the DRC's or operator's license.

5.2.4.1 Emergency endorsements shall be issued for a period not to exceed one year.

5.2.4.2 The operator must pass the appropriate endorsement examination within the one-year period of the emergency endorsement.

5.3 The Division shall provide a classification system for distribution system operators, when the holder of this classification is responsible for oversight of a distribution system and has no responsibilities for operations at the treatment plant.

**History**
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *8 DE Reg. 453 (09/01/04)*
- *17 DE Reg. 924 (03/01/14)*
- *23 DE Reg. 928 (05/01/20)*

##### **16 Del. Admin. Code § 4463-6.0** License Classification and Operator Qualifications {#sec-4463-6.0 omnilex-key=us-de-regs-official--title-16--4463-6.0}

6.1 License Classification

6.1.1 Base-level water supply operator with all applicable endorsements as stated in subsection 5.2.1 is hereby established.

6.1.2 Four specialty class licenses are also established:

6.1.2.1 Operator-in-training (OIT) license;

6.1.2.2 Grandfather clause license;

6.1.2.3 Limited license; and

6.1.2.4 Distribution license.

6.2 Operator Qualifications

6.2.1 Base-level water supply operator qualifications shall be:

6.2.1.1 High School Diploma or equivalent and one year of acceptable operating experience; or three years of acceptable operating experience; and

6.2.1.2 Successful completion of the base-level license written examination.

6.2.2 A water treatment OIT who lacks either the education or experience requirements for a base-level license may receive an interim OIT license for a maximum of one year, pending fulfillment of the regular license requirements. The interim OIT license depends on approval by the Secretary, recommendation by the Advisory Council, and successful completion of the base-level license written examination.

6.2.2.1 An OIT licensee must be employed at a water system performing the duties of an operator consistent with the definition of operator in these regulations continuously for one year before becoming eligible for a base-level license.

6.2.2.1.1 An applicant that passes the base-level license examination or distribution license examination must obtain employment with a Delaware community water system or non-transient non-community water system within two years of passing the examination. Failure to obtain employment within the two-year period will require retaking the appropriate examination and submittal of a new application with the applicable fee.

6.2.2.2 An OIT licensee must submit an application for a base-level license 30 days prior to the expiration of the OIT license in order to be eligible for a base-level license.

6.2.3 An operator who works for a non-transient non-community water system that is required to have a licensed operator may obtain a limited license. A limited license shall not be transferable to another public water system.

6.2.3.1 To obtain a limited license an operator must attend a course approved by the Division and pass the examination.

6.2.3.2 At the discretion of the Division, a limited license operator may be required to obtain endorsements for treatment and distribution processes used by the facility in the time frame set by the Division.

6.2.3.3 To renew a limited license, a limited license operator must obtain the required number of continuing education units in accordance with subsection 7.3.2 and submit an application with the applicable fee.

6.2.4 A distribution system operator may obtain a distribution license when they are responsible for oversight of a distribution system and have no responsibilities for operations at the treatment plant.

6.2.4.1 The qualifications for a distribution license shall include:

6.2.4.1.1 A high school diploma or equivalent and one year of acceptable operating experience, or three years of acceptable operating experience; and

6.2.4.1.2 Successful completion of the distribution license written examination.

6.2.5 A circuit rider/contract operator must meet the following requirements:

6.2.5.1 Obtain certification for all endorsements required for the water systems for which the circuit rider/contract operator is in direct responsible charge or operates.

6.2.5.2 Complete three weekly visits at each water system that provides any treatment and make at least one weekly visit for each system that has no treatment. The Advisory Council may adjust this number upon written request from the operator or owner of the water system justifying the requested change.

6.2.5.2.1 The number of weekly visits at each water system must be documented on forms approved by the Division and made available upon request. Information documented shall include, but not be limited to, the name of the water system, name of the operator, date of visit, time of visit, and activities performed.

6.2.5.2.2 For the purposes of this subsection, a DRC circuit rider/contract operator must be available in the event of an emergency to provide timely assistance that adequately addresses the emergency.

6.2.6 The Secretary shall not issue new grandfather clause licenses except for the license renewal of current grandfather clause licensees.

6.2.7 An applicant for any endorsements or sub-endorsements must have a minimum of one year of acceptable operating experience with the treatment process or distribution system in order to receive the endorsement on the license. Applicants that pass the endorsement examination, in accordance with subsection 7.1.1, may receive an OIT license for up to one year in order to obtain the necessary experience.

**History**
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *8 DE Reg. 453 (09/01/04)*
- *17 DE Reg. 924 (03/01/14)*
- *23 DE Reg. 928 (05/01/20)*

##### **16 Del. Admin. Code § 4463-7.0** Licensing Procedures {#sec-4463-7.0 omnilex-key=us-de-regs-official--title-16--4463-7.0}

7.1 The Division may enter into a contract with a third party to prepare, administer, and grade written examinations required for each category and classification of license.

7.1.1 A minimum score of 75 percent shall be considered passing.

7.1.2 Examinations are confidential and remain the property of the Advisory Council.

7.1.3 The Advisory Council may waive the requirements for the written examination, due to unusual and extenuating circumstances, and allow a recorded examination conducted and retained by the Advisory Council.

7.1.4 The Advisory Council shall designate the locations and times for examinations to be held and provide notification at least two months prior to the scheduled examination date. Examinations shall be held in January and June of each year.

7.1.5 Applicants must register with the Division a minimum of 30 days prior to the announced date of any licensing examination.

7.1.5.1 The Division shall produce registration forms available to the public.

7.1.5.2 The registration form shall not require personal references, a picture of the applicant, or information relating to citizenship, place of birth, or length of State residency.

7.1.6 Upon successful completion of the examination, applicants must meet all current requirements for licensure and submit an application to the Advisory Council with the applicable fee.

7.1.6.1 Any applicant that fails to submit an application with the applicable fee within 90 days of the first notification indicating they passed the examination must retake the examination and submit a new application with the applicable fee to the Advisory Council.

7.1.7 If an application is refused or rejected, an applicant may appeal in writing via certified mail to the Secretary within 30 days of receiving such notification. Any applicant who failed the examination has the right to an appeal before the Advisory Council.

7.1.8 Any applicant who fails to pass an examination may apply for re-examination. Applicants may sit for the same examination two times within a one-year period. Applicants who fail twice within a one-year period must wait one year before sitting for another examination.

7.2 Once an applicant satisfies requirements provided in this regulation and provides proof of employment with acceptable operating experience at a Delaware non-transient non-community water system or community water system, the applicant, upon recommendation by the Advisory Council, shall be issued a suitable license by the Secretary. The license shall indicate all endorsements for which the licensee is qualified, the date of issuance, and the date of expiration.

7.3 Renewal of License. It is the responsibility of the licensee to file a renewal application with the Advisory Council. The Advisory Council is not required to notify licensees of expiration dates.

7.3.1 Licenses shall be renewed every two years unless suspended, revoked for cause, or inactivated under subsection 7.4.

7.3.1.1 Applications for renewal must be submitted to the Advisory Council on the forms provided by the end of the licensing period. Applications for renewal postmarked after the end of the licensing period will be considered late.

7.3.2 All licensees must obtain 20 educational contact hours every two years to be eligible to renew their license.

7.3.2.1 OIT licensees may accrue educational contact hours during their OIT License period and, upon completion of their first base-level license period, apply them toward their base-level license renewal.

7.3.2.2 A minimum of 10 educational contact hours must be obtained in classes of a technical nature, directly related to waterworks operation, treatment, or distribution.

7.3.2.3 Operators are eligible to receive one educational contact hour, not directly related to waterworks operation, treatment, or distribution, for general attendance to a conference hosted by a nationally recognized organization related to drinking water and approved by the Division with proof of attendance as required by the Division.

7.3.2.4 Operators are eligible to receive one educational contact hour, not directly related to waterworks operation, treatment, or distribution, for each attendance to a regular meeting held by the Advisory Council, not to exceed four per year.

7.3.2.5 Educational contact hours are required of all licensees and shall be completed prior to the time a license is to be renewed. Extra educational contact hours do not carry over to the next licensing period. Licensees will only get educational contact hour credit for their first attendance of approved courses during each licensing period. Licensees may retake an approved course in the same licensing period but will not receive additional educational contact hour credit.

7.3.3 Any license that has not been renewed in accordance with subsections 7.3.1 and 7.3.2 shall be automatically inactivated. A license may be reactivated without examination upon payment of the applicable fee and verification of completion of continuing education requirements within one year from the end of the licensing period. Licensees who do not reinstate within one year of the expiration date must submit a new application to the Advisory Council and successfully complete the applicable written examinations to renew their licenses.

7.3.3.1 Continuing education units may be earned during the period of inactivation if the applicant does not have the required number of CEUs for renewal. CEUs earned during periods of inactivation do not carry over to the two-year term of the renewed license.

7.4 The Secretary may suspend or revoke the license of an operator after considering the recommendations of the Advisory Council when it is found that the operator has practiced fraud or deception; failed to use reasonable care, judgment, or the application of knowledge or ability in the performance of duties; or is incompetent or unable to perform duties properly.

7.4.1 The Advisory Council’s recommendation to the Secretary shall be made after conducting a hearing in accordance with provisions established under these regulations. Denial of renewal, suspension, or revocation of a license or placement on probation may result from actions that pose a significant or immediate public health risk and may include malfeasance, misfeasance, and nonfeasance.

7.5 Fees

7.5.1 A licensure fee as authorized by 16 Del.C. §122(3)(c) shall be assessed for initial and renewal licensures.

7.6 The Division may grant reciprocity and issue a license without examination to an applicant who holds a certificate or license in any state, territory, or possession of the United States or any country.

7.6.1 Reciprocity will be granted if, in the judgment of the Secretary, the requirements under which the certification or license was issued do not conflict with the provisions of these regulations or any rules promulgated hereunder, and are of a standard not lower than that specified by these regulations.

7.7 A licensee with an active license may request in writing to be placed on inactive status. Inactive status can be renewed electronically on a biennial basis by attestation with supporting documentation of completing the required continuing education for licensure. Inactive licensees may reactivate their license by submitting a written request to the Advisory Council with payment of the applicable fee as set by the Division.

7.7.1 An operator is not authorized to work as a licensed operator in this State during the period of inactive status.

**History**
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *8 DE Reg. 453 (09/01/04)*
- *17 DE Reg. 924 (03/01/14)*
- *23 DE Reg. 928 (05/01/20)*

##### **16 Del. Admin. Code § 4463-8.0** Statement of Ethics {#sec-4463-8.0 omnilex-key=us-de-regs-official--title-16--4463-8.0}

It is the responsibility of all operators to ensure the provision of safe drinking water to their customers by maintaining their license, ensuring they obtain relevant training, keeping up with all current and proposed regulations, maintaining accurate records, and addressing customer complaints in a timely manner.

**History**
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *8 DE Reg. 453 (09/01/04)*
- *17 DE Reg. 924 (03/01/14)*
- *23 DE Reg. 928 (05/01/20)*

##### **16 Del. Admin. Code § 4463-9.0** Preemption {#sec-4463-9.0 omnilex-key=us-de-regs-official--title-16--4463-9.0}

The provisions of these regulations preempt existing prior regulations of this State insofar as they relate to or conflict with the provisions of this regulation.

**History**
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *8 DE Reg. 453 (09/01/04)*
- *17 DE Reg. 924 (03/01/14)*
- *23 DE Reg. 928 (05/01/20)*

##### **16 Del. Admin. Code § 4463-10.0** Severability {#sec-4463-10.0 omnilex-key=us-de-regs-official--title-16--4463-10.0}

In the event any particular clause or section of these regulations should be declared invalid or unconstitutional by any court of competent jurisdiction, the remaining portions shall remain in full force and effect.

**History**
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *8 DE Reg. 453 (09/01/04)*
- *17 DE Reg. 924 (03/01/14)*
- *23 DE Reg. 928 (05/01/20)*

##### **16 Del. Admin. Code § 4463-11.0** Disciplinary Procedures {#sec-4463-11.0 omnilex-key=us-de-regs-official--title-16--4463-11.0}

11.1 Grounds for Discipline. An applicant or licensee may be subject to disciplinary sanctions if the applicant or licensed operator has:

11.1.1 Acted fraudulently or with material deception in order to be certified;

11.1.2 Engaged in illegal, incompetent or negligent conduct in the provision of water system operation;

11.1.3 As an operator or otherwise, in the practice of his or her profession, engaged in an act of consumer fraud or deception, or engaged in the restraint of competition, or participated in price-fixing activities; or

11.1.4 Violated a lawful provision of these regulations.

11.2 Disciplinary Sanctions. Persons regulated under this Section who have been determined to be in violation of these regulations may be subject to one or more of the following disciplinary actions:

11.2.1 Issuance of a letter of reprimand;

11.2.2 Placement on probationary status;

11.2.3 Imposition of a fine not to exceed $1,000 for each offense;

11.2.4 Suspension of license; or

11.2.5 Revocation of license.

11.3 Disciplinary Procedures

11.3.1 The Advisory Council may, upon sworn complaint or upon its own initiative, conduct an investigation to determine whether a licensee has engaged in any activity requiring disciplinary action.

11.3.2 Upon completion of the investigation, the Advisory Council shall forward a copy of the investigation report along with its recommendation to the Secretary.

11.3.2.1 The Secretary shall set the time and place for the hearing.

11.3.3 The Secretary shall cause a copy of the charges, together with a notice of the time and place set for the hearing, to be served on the alleged licensee 30 days before the date of the hearing.

11.3.3.1 In cases where the licensee cannot be located or where personal service cannot be affected, substitute service shall be affected in the same manner as with civil litigation.

11.3.4 In all proceedings herein:

11.3.4.1 The licensee may be represented by counsel who shall have the right of examination and cross-examination.

11.3.4.2 The licensee and the Secretary may subpoena witnesses and admit documentary evidence on their own behalf. Subpoenas shall be issued by the Department upon written request and shall be served as provided by the rules of the Superior Court and shall have like effect as a subpoena issued by said Court.

11.3.4.3 Testimony before the Secretary shall be under oath. The Secretary shall have power to administer oaths for this purpose.

11.3.4.4 A stenographic record of the hearing shall be made by a qualified court reporter. At the request and expense of any party, such record shall be transcribed with a copy to the other party.

11.3.4.5 The decision of the Secretary shall be based upon sufficient legal evidence.

11.3.4.5.1 If the charges are supported by such evidence, the Secretary may revoke, refuse to issue or suspend a license, or otherwise discipline the licensee.

11.3.4.5.1.1 Upon reaching their conclusion of law and determining an appropriate disciplinary action, if any, the Secretary shall issue a written decision and order in accordance with 29 Del.C. §10128. The order must restate the factual findings, but need not summarize the evidence presented. However, notwithstanding the provisions of 29 Del.C. §10128(c), the decision and order may be issued over the signature of only the Secretary. The decision and order must be sent by certified mail with return receipt requested to the licensee with a copy to the Director of the Division of Public Health.

11.3.4.5.2 A suspended license may be reinstated upon further review by the Secretary at the request of the licensee. As a condition of reinstatement of a suspended license, the Agency in consultation with the Advisory Council may impose any condition or conditions including but not limited to a requirement to take an examination. Before reinstating a suspended license, the Secretary shall, without a hearing, make a determination as to whether the licensee has taken the required corrective actions and has satisfied all the conditions imposed pursuant to the suspension. A licensee who disagrees with a determination made by the Secretary may request a hearing before the Secretary. The written request must be made 10 days from the date of the decision.

11.3.4.6 All decisions of the Secretary shall be final and conclusive. Where the licensee is in disagreement with the action of the Secretary, the licensee may appeal the Secretary’s decision to the Superior Court within 30 days of service or of the postmarked date of the copy of the decision mailed to the practitioner. The appeal shall be on the record to the Superior Court and shall be as provided in §§10142-10145 of Title 29.

11.4 Reapplication of License after Revocation. An operator that has had a license revoked by the Secretary may submit an application to the Advisory Council for renewal of the license. An application for a license after revocation shall not be submitted for at least one year after the date of revocation.

**History**
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *8 DE Reg. 453 (09/01/04)*
- *17 DE Reg. 924 (03/01/14)*
- *23 DE Reg. 928 (05/01/20)*

##### **16 Del. Admin. Code § 4463-12.0** Penalty Clause {#sec-4463-12.0 omnilex-key=us-de-regs-official--title-16--4463-12.0}

Any person who neglects or fails to comply with these regulations shall be subject to penalty as provided in 16 Del.C. §122(3)(c).

Listed below are the general endorsement categories. Under each general category is a list of the endorsement sub-categories (unit processes) associated with each general category.

A. Disinfection

1. Hypochlorination (Calcium or Sodium), powder or liquid

2. Gas Chlorination

3. Ozonation

4. [Reserved]

5. [Reserved]

6. Chloramines

7. Chlorine Dioxide

8. Ultraviolet Light

B. Chemical Feed

1. Lime - Soda Ash Addition

2. pH Adjustment

3. Inhibitor - bimetallic phosphate, hexametaphosphate, orthophosphate, polyphosphate

4. Sequestering

5. Permanganate

6. [Reserved]

7. Fluoridation

C. Filtration

1. Activated Carbon, powder or granulated

2. Sand - Pressure, Rapid, Slow

3. Reverse Osmosis

4. Greensand

5. Activated Alumina

6. Ion Exchange

7. Cartridge

8. [Reserved]

9. Ultrafiltration

10. Microfiltration

D. Surface Water Operations

1. Algae Control

2. Coagulation

3. Flocculation

4. Rapid Mix

5. Sedimentation

6. Sludge Treatment

E. Other Specified Treatment

1. Aeration - Cascade, Diffused, Packed Tower, Slat Tray or Spray

2. Dechlorination - using reducing agents, sodium bisulfate, sodium sulfide, or sulfur dioxide

3. Distillation

4. [Reserved]

5. Electrodialysis

F. Distribution

1. Flow less than 500 gpm at 20 psi

2. Flow greater than 500 gpm at 20 psi

G. Approved Sampler/Tester

**History**
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *23 DE Reg. 928 (05/01/20)*
- *8 DE Reg. 453 (09/01/04)*
- *17 DE Reg. 924 (03/01/14)*
- *23 DE Reg. 928 (05/01/20)*

#### **4464** Public Swimming Pools

##### **16 Del. Admin. Code § 4464-1.0** General Provisions {#sec-4464-1.0 omnilex-key=us-de-regs-official--title-16--4464-1.0}

1.1 Preamble. The Secretary of Delaware Health and Social Services adopts these Regulations pursuant to the authority vested in the Secretary by 16 Del.C. §122. These Regulations establish standards for the sanitary operation of public pools. For the purpose of these Regulations, the term “public pool” as defined in 16 Del.C. §122(1) and (3) (d) and (j). These Regulations provide a system of permitting and inspection of public pools and procedures for enforcement.

1.1.1 These Regulations are adopted on October 1, 2015 and have an effective date of October 11, 2015.

1.2 Purpose. To provide minimum standards for design, construction, maintenance and operation of public pools in the State of Delaware, and to assure a clean, healthful, and safe environment for all bathers using these pools. These Regulations in no way preclude a facility from establishing additional rules and operating procedures as long as they do not contradict those established herein.

1.3 Severability. In the event any particular clause or section of these Regulations should be declared invalid or unconstitutional by any court of competent jurisdiction, the remaining portions shall remain in full force and effect.

1.4 Exemptions.

1.4.1 There is no requirement of a lifeguard to be on duty at any pool of any motel, hotel or private campground facility, however an attendant is required.

1.4.2 These Regulations shall not apply to pools that are used by one (1) patron at a time and whose water is completely changed after each patron.

1.4.3 These regulations shall not apply to pools that have been granted private pool status.

1.5 Variance

1.5.1 A licensee may seek a variance from these Regulations by making a request for variance to the Division. The Division may grant a variance by modifying or waiving the requirements of these Regulations if in the opinion of the Division a health hazard or nuisance will not result from the variance.

1.5.2 A variance shall not be transferable from person to person, or from location to location.

1.5.3 If a variance is granted, the Division shall retain the information specified below in its records for the public pool.

1.5.3.1 A statement of the proposed variance of the requirement of these Regulations, citing the relevant section of these Regulations;

1.5.3.2 An analysis of the rationale for how the potential public health hazards or nuisances will be alternatively addressed by the proposal; and

1.5.3.3 Any other information requested by the Division that may be deemed necessary to render judgment.

1.5.3.4 A variance is rendered void upon occurrence of one or more of the following:

1.5.3.4.1 the physical facility is demolished or

1.5.3.4.2 a remodeling project in the facility includes the area(s) addressed in the variance

**History**
- *19 DE Reg. 309 (10/01/15)*

##### **16 Del. Admin. Code § 4464-2.0** Definitions {#sec-4464-2.0 omnilex-key=us-de-regs-official--title-16--4464-2.0}

For the purposes of these Regulations the following definitions apply:

“Approved” means acceptable to the Division, unless stated otherwise, based on its determination as to conformance with appropriate standards and good public health practices.

“Aquatic Facility” means a physical place that contains one or more aquatic venues and support infrastructure.

“Aquatic Facility or Aquatic Venue Enclosure” means an uninterrupted barrier surrounding and securing an aquatic facility or aquatic venue.

“Aquatic Feature” means an individual component within an aquatic venue. Examples include slides, structures designed to be climbed or walked across, and structures that create falling or shooting water.

“Aquatic Venue” means an artificially constructed structure or modified natural structure where the general public is exposed to water intended for recreational or therapeutic purpose. Such structures do not necessarily contain standing water, so water exposure may occur via contact, ingestion, or aerosolization. Examples include swimming pools, wave pools, lazy rivers, surf pools, spas (including spa pools and hot tubs), therapy pools, waterslide landing pools, spray pads, and other interactive water venues.

“Attendant” means a person who meets the training requirements of the Division specified in Section 9.7.

“Attendant on Duty” means an attendant who is either at poolside or in the pool (special situations), visually guarding the life of the bathers. An attendant on duty shall not be assigned other duties that will distract his/her attention from proper observation of the bathers, or prevent the rendering of immediate assistance to someone in distress. In facilities with a spa pool(s) only it means an attendant who is on the premises and can be easily located and summoned to render assistance to someone in distress. If the attendant is not in direct view of the spa pool when it is open, he/she shall be located such that the poolside alarm required by Section 9.19. can be easily heard.

“Automated Controller” means a system of at least one chemical probe, a controller, and auxiliary or integrated component that senses the level of one or more water parameters and provides a signal to other equipment to maintain the parameters within a user-established range.

“Backflow” means a hydraulic condition caused by a difference in water pressure that causes an undesirable reversal of the flow as the result of a higher pressure in the system than in its supply.

“Bather” means a person at an aquatic venue who has contact with water either through spray or partial or total immersion. The term bather as defined, also includes staff members, and refers to those users who can be exposed to contaminated water as well as potentially contaminate the water.

“Bather Count” means the number of bathers in an aquatic venue at any given time.

“Beneficial Owner” means an ownership interest in the entity owning the pool through direct ownership of the real property where the pool is located, direct ownership of stock in a stock corporation owning the real property where the stock represents an equity interest in the corporation, or direct ownership through being a member in a limited liability company (L.L.C.) or a partner in a partnership owning the real property upon which the pool is placed.

“Breakpoint Chlorination” means the conversion of inorganic chloramine compounds to nitrogen gas by reaction with Free Available Chlorine. When chlorine is added to water containing ammonia (from urine, sweat, or the environment, for example), it initially reacts with the ammonia to form monochloramine. If more chlorine is added, monochloramine is converted into dichloramine, which decomposes into nitrogen gas, hydrochloric acid and chlorine. The apparent residual chlorine decreases since it is partially reduced to hydrochloric acid. The point at which the drop occurs is referred to as the “breakpoint”. The amount of free chlorine that must be added to the water to achieve breakpoint chlorination is approximately ten times the amount of combined chlorine in the water. As additional chlorine is added, all inorganic combined chlorine compounds disappear, resulting in a decrease in eye irritation potential and “chlorine odors.”

“Chemical Storage Space” means a space in an aquatic facility used for the storage of pool chemicals such as acids, salt, or corrosive or oxidizing chemicals. “Chemical Storage Space” means a space in an aquatic facility used for the storage of pool chemicals such as acids, salt, or corrosive or oxidizing chemicals.

“Chlorine” means an element that at room temperature and pressure is a heavy greenish yellow gas with a characteristic penetrating and irritating smell; it is extremely toxic. It can be compressed in liquid form and stored in heavy steel tanks. When mixed with water, chlorine gas forms hypochlorous acid, the primary chlorine-based disinfecting agent, hypochlorite ion, and hydrochloric acid. Hypochlorous acid dissociation to hypochlorite ion is highly pH dependent. Chlorine is a general term used in these regulations which refers to hypochlorous acid and hypochlorite ion in aqueous solution derived from chlorine gas or a variety of chlorine-based disinfecting agents.

“Competitive Diving” means either the training of divers or an actual diving competition among trained divers, which is sanctioned by the Federation International de Natation Amateur (FINA), the National Collegiate Athletic Association (NCAA), the National Federation of State High School Associations (NFSHSA) or United States Diving Inc. (USD). The institution which is sponsoring the diving training or diving competition shall be responsible for the hiring of a qualified person(s) who is competent and knowledgeable in the areas of diving mechanics and safety. This person(s) shall be present at every practice session and competition in order to ensure proper training, supervision and safety.

“Contaminant” means a substance that soils, stains, corrupts, or infects another substance by contact or association.

“Contamination Response Plan” means a plan for handling contamination from formed-stool, diarrheal-stool, vomit, and blood.

“Corrosive Materials” means pool chemicals, fertilizers, cleaning chemicals, oxidizing cleaning materials, salt, de-icing chemicals, other corrosive or oxidizing materials, pesticides, and such other materials which may cause injury to people or damage to the building, air-handling equipment, electrical equipment, safety equipment, or fire-suppression equipment, whether by direct contact or by contact via fumes or vapors, whether in original form or in a foreseeably likely decomposition, pyrolysis, or polymerization form. Refer to labels and SDS forms.

“Crack” means any and all breaks in the structural shell of a pool vessel or deck.

“Cross-Connection” means a connection or arrangement, physical or otherwise, between a potable water supply system and a plumbing fixture, tank, receptor, equipment, or device, through which it may be possible for non-potable, used, unclean, polluted and contaminated water, or other substances to enter into a part of such potable water system under any condition.

“CT Value” means a representation of the concentration of the disinfectant (C) multiplied by time in minutes (T) needed for inactivation of a particular contaminant. The concentration and time are inversely proportional; therefore, the higher the concentration of the disinfectant, the shorter the contact time required for inactivation. The CT value can vary with pH or temperature change so these values must also be supplied to allow comparison between values.

“Cyanuric Acid” means a chemical added to pool water intended to counteract degradation of the chlorine residual by ultraviolet light.

“Deck” means surface areas serving the aquatic venue, including the perimeter/wet deck, pool deck, and dry deck.

“Diaper-Changing Station” means a hygiene station that includes a diaper-changing unit, hand-washing sink, soap and dispenser, a means for drying hands, trash receptacle, and disinfectant products to clean after use.

“Diaper-Changing Unit” means a diaper-changing surface that is part of a diaper-changing station.

“Dichloramine” means a disinfection by-product formed when chlorine binds to nitrogenous waste in pool water to form an amine- containing compound with two chlorine atoms (NHCl2). It is a known acute respiratory and ocular irritant.

“Director” means the Director of the Division of Public Health or an authorized agent.

“Disinfection” means a treatment that kills or irreversibly inactivates microorganisms (e.g., bacteria, viruses, and parasites); in water treatment, a chemical (commonly chlorine, chloramine, or ozone) or physical process (e.g., ultraviolet radiation) can be used.

“Disinfection By-Product” means a chemical compound formed by the reaction of a disinfectant (e.g. chlorine) with a precursor (e.g. natural organic matter, nitrogenous waste from bathers) in a water system (pool, water supply).

“Diving” means a head first entry into a body of water.

"Division" means the Division of Public Health of the Department of Health and Social Services, or anyone authorized by the Division as its designated representative, in conformance with 29 Del.C. §7904.

“Emergency Action Plan” means a plan that identifies the objectives that need to be met for a specific type of emergency, who will respond, what each person’s role will be during the response and what equipment is required as part of the response.

“Enclosure” means an uninterrupted constructed feature or obstacle used to surround and secure an area that is intended to deter or effectively prevent unpermitted, uncontrolled, and unfettered access. It is designed to resist climbing and to prevent passage through it and under it. Enclosure can apply to aquatic facilities or aquatic venues.

“Environmental Health Survey” means a comprehensive on-site review of the facilities, operation and management of a pool for the purpose of determining whether a safe environment and bathing water of acceptable quality are being provided.

“EPA Registered” means all products regulated and registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) by the U.S. Environmental Protection Agency (EPA; http://www.epa.gov/agriculture/lfra.html). EPA registered products will have a registration number on the label (usually it will state “EPA Reg No.” followed by a series of numbers). This registration number can be verified by using the EPA National Pesticide Information Retrieval System (http://ppis.ceris.purdue.edu/#).

“Equipment Room” means a space intended for the operation of pool pumps, filters, heaters, and controllers. This space is not intended for the storage of hazardous pool chemicals.

“Exit Gate” means an emergency exit, which is a gate or door allowing free exit at all times.

“Expansion Joint” means a watertight joint provided in a pool vessel used to relieve flexural stresses due to movement caused by thermal expansion/contraction.

“Fence” means a continuous vertical barrier, either solid, or with openings, holes or gaps not exceeding four (4) inches in diameter or width, completely enclosing the pool area which will prevent the entry of small children and minimize the entry of unauthorized or unwary persons.

“Flume” means the riding channels of a waterslide which accommodate riders using or not using mats, tubes, rafts, and other transport vehicles as they slide along a path lubricated by a water flow.

“Foot Baths” means standing water in which bathers or aquatics staff rinse their feet.

“Ground-Fault Circuit Interrupter” means a device for protection of personnel that de-energizes an electrical circuit or portion thereof in the event of excessive ground current.

“Guardian” is an adult designated by a parent who is responsible for the children and their behavior.

“Halogen” means one of the chemical elements chlorine, bromine, or iodine.

“Hand Wash Station” means a location which has a hand wash sink, adjacent soap with dispenser, hand drying device or paper towels and dispenser, and trash receptacle.

“Hot Water” means an aquatic venue with water temperature over 90 degrees Fahrenheit (30 degrees Celsius).

“Hygiene Facility” means a structure or part of a structure that contains toilet, shower, diaper-changing unit, hand wash station, and dressing capabilities serving bathers and patrons at an aquatic facility.

“Hygiene Fixtures” means all components necessary for hygiene facilities including plumbing fixtures, diaper-changing stations, hand wash stations, trashcans, soap dispensers, paper towel dispensers or hand dryers, and toilet paper dispensers.

“Hyperchlorination” means the intentional and specific raising of chlorine levels for a prolonged period of time to inactivate pathogens following a fecal or vomit release in an aquatic venue as outlined in these regulations Section 9.28.

“Imminent Health Hazard” means a significant threat or danger to health that is considered to exist when there is evidence sufficient to show that a product, practice, circumstance, or event creates a situation that requires immediate correction or cessation of operation to prevent injury based on the number of potential injuries and the nature, severity, and duration of the anticipated injury or illness.

“Inactive Pool” means a pool which has been closed for twelve (12) or more continuous months.

“Indoor Aquatic Facility” means a physical place that contains one or more aquatic venues and the surrounding bather and spectator/stadium seating areas within a structure that meets the definition of “Building” per the 2012 International Building Code. It does not include equipment, chemical storage, or bather hygiene rooms or any other rooms with a direct opening to the aquatic facility. Otherwise known as a natatorium.

“Infinity Edge” means a pool wall structure and adjacent perimeter deck that is designed in such a way where the top of the pool wall and adjacent deck are not visible from certain vantage points in the pool or from the opposite side of the pool. Water from the pool flows over the edge and is captured and treated for reuse through the normal pool filtration system. They are often also referred to as “vanishing edges,” “negative edges,” or “zero edges.”

“Inlet” means wall or floor fittings where treated water is returned to the pool.

“Interactive Water Play Aquatic Venue” means any indoor or outdoor installation that includes sprayed, jetted or other water sources contacting bathers and not incorporating standing or captured water as part of the bather activity area. These aquatic venues are also known as splash pads, spray pads, wet decks. For the purposes of these regulations, only those designed to recirculate water and intended for public use and recreation shall be regulated.

“Island” means a structure inside a pool where the perimeter is completely surrounded by the pool water and the top is above the surface of the pool.

“Lifeguard on Duty” means a lifeguard who is either poolside or in the pool (special situations), visually guarding the life of the bathers. A lifeguard on duty shall not be assigned other duties that will distract his/her attention from proper observation of the bathers, or prevent the rendering of immediate assistance to someone in distress.

“mg/L” means milligrams per liter and is the equivalent metric measure to parts per million (PPM).

“Monitoring” is the regular and purposeful observation and checking of systems or facilities and recording of data, including system alerts, excursions from acceptable ranges, and other facility issues. Monitoring includes human or electronic means.

“No Diving Marker” means a sign with the words “No Diving” and the universal international symbol for “No Diving” pictured as an image of a diver with a red circle with a slash through it.

“NTU” means Nephelometric Turbidity Unit which is a means of measuring the water turbidity.

“Oocyst” means the thick-walled, environmentally resistant structure released in the feces of infected animals that serves to transfer the infectious stages of sporozoan parasites (e.g., Cryptosporidium) to new hosts.

“ORP” means oxidation reduction potential which is an electrical measurement in millivolts (mV) of the strength of the disinfectant (oxidizer). A higher ORP means a higher disinfecting potential.

“Oxidation” means the process of changing the chemical structure of water contaminants by either increasing the number of oxygen atoms or reducing the number of electrons of the contaminant or other chemical reaction, which allows the contaminant to be more readily removed from the water or made more soluble in the water. It is the “chemical cleaning” of pool water. Oxidation can be achieved by common disinfectants (e.g., chlorine, bromine), secondary disinfection/sanitation systems (e.g. ozone) and oxidizers (e.g. potassium monopersulfate).

“Oxidation Reduction Potential” means a measure of the tendency for a solution to either gain or lose electrons; higher (more positive) oxidation reduction potential indicates a more oxidative solution.

“Patron” means a bather or other person or occupant at an aquatic facility who may or may not have contact with aquatic venue water either through partial or total immersion. Patrons may not have contact with aquatic venue water, but could still be exposed to potential contamination from the aquatic facility air, surfaces, or aerosols.

“Peninsula / Wing Wall” means a structural projection into a pool intended to provide separation within the body of water.

“Perimeter Gutter System” means the alternative to skimmers as a method to remove water from the pool’s surface for treatment. The gutter provides a level structure along the pool perimeter versus intermittent skimmers.

“Person” means any corporation, company, association, firm, partnership, society, joint stock company or individual.

“Person in Charge” means the/an owner of the pool. This individual shall represent the pool at any hearing scheduled pursuant to 15.3. Every pool shall, upon request, provide the Division with the name of the person(s) in charge and how they can be contacted. An operator, hired by the/an owner, cannot be the person in charge.

“pH” means the negative log of the concentration of hydrogen ions. When water ionizes, it produces hydrogen ions (H+) and hydroxide ions (OH-). If there is an excess of hydrogen ions the water is acidic. If there is an excess of hydroxide ions the water is basic. pH ranges from 0 to 14. Pure water has a pH of 7.0. If pH is higher than 7.0, the water is said to be basic, or alkaline. If the water’s pH is lower than 7.0, the water is acidic. As pH is raised, more ionization occurs and chlorine disinfectants decrease in effectiveness.

“Plumbing Fixture” means a receptacle, fixture, or device that is connected to a water supply system or discharges to a drainage system or both and may be used for the distribution and use of water; for example: toilets, urinals, showers, and hose bibs. Such receptacles, fixtures, or devices require a supply of water; or discharge liquid waste or liquid-borne solid waste; or require a supply of water and discharge waste to a drainage system.

“Pool” means a subset of aquatic venues designed to have standing water for total or partial bather immersion. This does not include spas.

“Private Pool” means any indoor or outdoor artificial basin containing a body of water which is used for swimming, wading, diving, recreative bathing, or other aquatic purposes and is not open to the general public, or a limited section of the public, but is intended strictly for the use of the beneficial owner(s) and his/her/their family and/or their guests in either of the following situations:

“Public Water Systems” means water systems including community water systems, non-transient/non-community water systems, or transient non-community water systems with exceptions as noted by the Division and EPA.

“Qualified Lifeguard” means an individual who has successfully completed a Division recognized lifeguard training course offered by a Division recognized training agency, holds a current certificate for such training, has met the pre-service requirements, and is participating in continuing in-service training requirements of the aquatic facility.

“Qualified Lifeguard Supervisor” means an individual responsible for the oversight of lifeguard performance and emergency response at an aquatic facility. A qualified lifeguard supervisor is an individual who has successfully completed a lifeguard supervisor training course and holds an unexpired certificate for such training; and who has met the pre-service and continuing in-service requirements of the aquatic facility according to this code.

“Qualified Operator” means an individual, that is at least 18 years old, that is responsible for the operation and maintenance of the water and air quality systems and the associated infrastructure of the aquatic facility and who has successfully completed a Division recognized operator training course to operate an aquatic facility offered by a Division recognized training agency and holds a current certificate for such training.

“Recessed Steps” means a way of ingress/egress for a pool similar to a ladder but the individual treads are recessed into the pool wall.

“Recirculation System” means the combination of the main drain, gutter or skimmer, inlets, piping, pumps, controls, surge tank or balance tank to provide pool water recirculation to and from the pool and the treatment systems.

“Reduction Equivalent Dose (RED) bias” means a variable used in UV system validation to account for differences in UV sensitivity between the UV system challenge microbe and the actual microbe to be inactivated (e.g., Cryptosporidium).

“Re-entrainment” means a situation where the exhaust(s) from a ventilated source such as an indoor aquatic facility is located too close to the air handling system intake(s), which allows the exhausted air to be re-captured by the air handling system so it is transported directly back into the aquatic facility.

“Responsible Supervisor” means an individual on-site that is responsible for water treatment operations when a “qualified operator” is not on-site at an aquatic facility.

“Robotic Cleaner” means a modular vacuum system consisting of a motor-driven, in-pool suction device, either self-powered or powered through a low voltage cable, which is connected to a deck-side power supply.

“Run-Out Slide” means that part of a waterslide where riders are intended to decelerate and/or come to a stop. The runout is a continuation of the waterslide flume surface.

“Safety” (as it relates to construction items) means a design standard intended to prevent inadvertent or hazardous operation or use (i.e., a passive engineering strategy).

“Safety Plan” means a written document that has procedures, requirements and/or standards related to safety which the aquatic facility staff shall follow. These plans include training, emergency response, and operations procedures.

“Safety Team” means any employee of the aquatic facility with job responsibilities related to the aquatic facility’s emergency action plan.

“Sanitize” means reducing the level of microbes to that considered safe by public health standards. This may be achieved through a variety of chemical or physical means including chemical treatment, physical cleaning, or drying.

“Saturation Index” means a mathematical representation or scale representing the ability of water to deposit calcium carbonate, or dissolve metal, concrete or grout.

“Secondary Disinfection Systems” means those disinfection processes or systems installed in addition to the standard systems required on all aquatic venues, which are required to be used for increased risk aquatic venues.

“Secretary, Delaware Health and Social Services” means the Administrator of the Department of Health and Social Services (DHSS) of the State of Delaware, who shall hereafter in this document be referred to as the Secretary, DHSS in conformance with 29 Del.C. §7904.

“Shower” means a device that sprays water on the body.

“Skimmer” means a device installed in the pool wall whose purpose is to remove floating debris and surface water to the filter. They shall include a weir to allow for the automatic adjustment to small changes in water level, maintaining skimming of the surface water.

“Skimmer System” means periodic locations along the top of the pool wall for removal of water from the pool’s surface for treatment.

“Slide” means an aquatic feature where users slide down from an elevated height into water.

“Slip Resistant” means a textured surface that is neither conducive to slipping when wet nor abrasive to bare feet and has a minimum static coefficient of friction of 0.6 (measured by an approved method).

“Standard” means something established by authority, custom, or general consent as a model for example.

“Structural Crack” means a break or split in the pool surface that weakens the structural integrity of the vessel.

“Substantial Alteration” means the alteration, modification, or renovation of an aquatic venue (for outdoor aquatic facilities) or indoor aquatic facility (for indoor aquatic facilities) where the total cost of the work exceeds 50% of the replacement cost of the aquatic venue (for outdoor aquatic facilities) or indoor aquatic facility (for indoor aquatic facilities).

“Superchlorinate” means the addition of large quantities of chlorine-based chemicals to kill algae, destroy odors, or improve the ability to maintain a disinfectant residual. This process is different from Hyperchlorination, which is a prescribed amount to achieve a specific CT value whereas Superchlorination is the raising of free chlorine levels for water quality maintenance.

“Supplemental Treatment Systems” means those disinfection processes or systems which are not required on an aquatic venue for health and safety reasons. They may be used to enhance overall system performance and improve water quality.

“Theoretical Peak Occupancy” means the anticipated peak number of bathers in an aquatic venue or the anticipated peak number of occupants of the decks of an aquatic facility. This is the lower limit of peak occupancy to be used for design purposes for determining services that support occupants. Theoretical peak occupancy is used to determine the number of showers. For aquatic venues, the theoretical peak occupancy is calculated around the type of water use or space:

“Trichloramine” means a disinfection by-product formed when chlorine binds to nitrogenous waste in pool water to form an amine-containing compound with three chlorine atoms (NCl3). It is a known acute respiratory and ocular irritant. It has low solubility in water and is rapidly released into the air above pools where it can accumulate, particularly in indoor settings.

“Trihalomethanes” means chemical compounds in which three of the four hydrogen atoms of methane (CH4) are replaced by halogen atoms.

“Turbidity” means a measure of the clarity or cloudiness of water

"Turnover" or "Turnover Rate" means the period of time, usually expressed in hours, required to circulate a volume of water equal to the capacity of the aquatic venue.

“Underwater Bench” means a submerged seat with or without hydrotherapy jets.

“Underwater Ledge” or “Underwater Toe Ledge” means a continuous step in the pool wall that allows swimmers to rest by standing without treading water.

“UV Transmissivity” means the percentage measurement of ultraviolet light able to pass through a solution.

“Water Replenishment System” means a way to remove water from the pool as needed and replace with make-up water in order to maintain water quality.

“Water Quality Testing Device” means a product designed to measure the level of a parameter in water. A WQTD includes a device or method to provide a visual indication of a parameter level, and may include one or more reagents and accessory items.

“Zero Depth Entry” means a sloped entry into a pool from deck level into the interior of the pool as a means of access and egress.

**History**
- *19 DE Reg. 309 (10/01/15)*

##### **16 Del. Admin. Code § 4464-3.0** Preoperational Requirements {#sec-4464-3.0 omnilex-key=us-de-regs-official--title-16--4464-3.0}

3.1 Permits

3.1.1 No person shall operate a public pool who does not have a valid permit issued by the Division. Only a person who complies with the requirements of these Regulations shall be entitled to receive or retain such a permit.

3.1.2 An establishment’s valid permit shall be posted in a location easily observed by the customer.

3.1.3 Permits shall not be transferable from person to person or from location to location.

3.1.4 When a public pool changes ownership, management firm, or lessee, both the facility and its operation shall be brought into full compliance with these Regulations prior to the issuance of a permit. A variance may be issued, as provided by these Regulations.

3.1.5 Establishments in compliance with these Regulations shall be issued a permit in accordance with Section 3.3. of these Regulations. Establishments that continue to operate without proper permits from the Division or operate in violation of these Regulations will be subject to legal remedial actions and sanctions as provided by law.

3.2 Operating Permit - No person shall operate a pool without a valid permit from the Division and operating permits shall expire annually. The operating permit is not transferable if either the pool name or ownership changes. The operating permit shall be available for viewing by any patron or representative of the Division upon request

3.3 Issuance of Permits

3.3.1 Any person desiring to operate a public pool shall make written application for a permit. Such application shall be made on forms provided by the Division and shall include the name and address of each applicant, the location and type of the proposed establishment and the signature of each applicant.

3.3.2 Upon issuance of an application an applicant shall permit the Division to enter the proposed public pool to conduct an inspection.

3.3.3 The Division shall issue a permit to the applicant if its inspection reveals that the proposed public pool complies with these Regulations.

3.3.4 A permit is no longer valid upon occurrence of one or more of the following events:

3.3.4.1 the establishment is closed for a period of sixty (60) days or more;

3.3.4.2 a new owner, firm, or lessee takes possession of the establishment; or

3.3.4.3 the permit is revoked by the Division for violation of these Regulations.

3.3.5 Inactive Pools

3.3.5.1 Any pool which closes for twelve (12) or more continuous months shall:

3.3.5.1.1 be classified as inactive;

3.3.5.1.2 contact the Division for an Environmental Health Survey prior to re-opening; and

3.3.5.1.3 make whatever changes are deemed necessary to achieve compliance with the current Regulations.

3.3.5.2 If the inactive pool does not have its own recirculation/filtration/disinfection system, this shall be provided prior to receiving approval to reopen.

3.3.5.3 If there is no intention of reopening an inactive pool, it shall be properly abandoned (filled with dirt to ground level).

3.3.5.4 Outdoor inactive pools shall be equipped with a tightly fitting cover during mosquito breeding season (normally May through September).

3.4 Submission of Plans

3.4.1 No person shall construct, install, alter or replace a pool, auxiliary pool structure, or pool equipment and no person shall convert a private pool to a public pool until three (3) copies of plans and specifications have been submitted to the Division, and an Approval to Construct has been issued. Whenever it is discovered that any of the above have occurred or are occurring without such approval, the Director shall order the owner, operator or contractor to immediately close the pool if it is open or stop the work or conversion, and to submit plans and specifications to the Division. Any part of the unapproved work or pool that is not in compliance with these Regulations shall be removed, replaced or reconstructed in order to achieve compliance. Plans and specifications shall be legible and on paper no larger than 30" X 42" and shall include, but are not limited to the following information:

3.4.1.1 The facility name and the name and telephone number of a contact person at or near the site.

3.4.1.2 The name, mailing address and telephone number of the owner.

3.4.1.3 The name, mailing address and telephone number of the builder/contractor/engineer.

3.4.1.4 A map of the area (city, town, rural area, etc.) showing the project location and a scaled drawing of the site showing the pool location.

3.4.1.5 A scaled drawing showing an overhead view of the pool which includes the location of but is not limited to: all recirculation system fittings and piping, depth markings, steps/ladders, diving board, lifeguard stand, fillspout, safety line/bottom marking, lights (underwater and overhead), deck/walkway, fence, pump/filter room*, bathhouse facilities, food/beverage service facilities and any other pools (e.g. wading pool, spa pool). This drawing shall also specify the materials of construction for the pool and deck, and the color of the pool walls and floor. If wood is planned for the wet deck/walkway area the manufacturer of the wood shall be specified, and if the wood has been treated by the manufacturer or will be treated by the installer, any preservatives, coatings, paints, etc. shall be specified.

3.4.1.6 *Either on this drawing or a separate sheet, a blown up scaled drawing of the pump/filter room showing all piping, equipment, fittings, and the flow pattern shall be provided.

3.4.1.7 A scaled drawing showing a profile view(s) of the pool, the pool depths and the relative elevation of the pump and filter. If a diving board is planned, an end view showing the required dimensions shall also be provided.

3.4.1.8 The following pool information: volume, water surface area, perimeter, filter type, filter surface area, design flow rate, recirculation pump capacity, total dynamic head (TDH) in feet [if not provided a minimum of sixty (60) TDH will be used], pool turnover time, and the size and type of all piping (i.e. ductile iron, copper, plastic).

3.4.1.9 Specifications for and drawings or pictures of all recirculation system components, including but not limited to: skimmers* or gutters; drains; inlets; recirculation pump with pump curve; rate of flow indicator with manufacturer’s installation instructions; the type, brand and surface area in square feet of the filter(s)*; multiport valve*; the type, brand and capacity of automatic disinfection equipment*; heater (including proof of AGA or UL approval); portable vacuum equipment; and the chemical name of the disinfectant to be used. All specifications shall include the manufacturer’s name and model #.

3.4.1.10 *Specifications shall include proof of NSF International listing, or approved equivalent. In the remainder of these Regulations, wherever there is a referral to NSF, it means NSF International or approved equivalent.

3.4.1.11 The source of potable water (i.e. their own on-site well or the name of the water supplier if the water comes from off-site), and the location and methods of disposal for sanitary waste, filter backwash water and pool water pumped to waste.

3.4.1.12 For new pools, the following signed statement from the owner in all three (3) sets of plans and specifications: “I hereby acknowledge that all items either listed or shown in these plans and specifications as not in contract (NIC), by others, or equivalent, are my responsibility. I also realize that this entire project must be completed in accordance with the approved plans and specifications, and all conditions listed in the Approval to Construct, prior to the issuance of an operating permit by the Division.” This statement with signature may appear directly on the plan drawings.

3.4.1.13 For changes to existing pools, the following signed statement from the owner: “I hereby acknowledge that all items either listed or shown in these plans and specifications as not in contract (NIC), by others, or equivalent, are my responsibility. I also realize that this entire project must be completed in accordance with the approved plans and specifications, and all conditions listed in the Approval to Construct, prior to this pool receiving permission from the Division to reopen.” This statement with signature may appear directly on the plan drawings.

3.4.2 Upon receipt of plans and specifications, the Division shall determine if the project is approved or disapproved and notify the responsible person within thirty (30) days. If disapproved, the reasons shall be specified. If approved, an Approval to Construct shall be issued which shall be valid for one (1) year. All construction shall be in accordance with the approved plans and specifications, and all conditions listed in the Approval to Construct. Prior to opening, the owner or operator of a new pool shall contact the Division for a pre-operational inspection in order to receive an operating permit. The Division reserves the right to reject plans and specifications from a pool builder/pool service company based upon evidence of malfeasance or non-feasance related to a previous Approval to Construct.

**History**
- *19 DE Reg. 309 (10/01/15)*

##### **16 Del. Admin. Code § 4464-4.0** Inspections {#sec-4464-4.0 omnilex-key=us-de-regs-official--title-16--4464-4.0}

4.1 Inspections and Right of Access

4.1.1 Site Inspection - Prior to the issuance of an Approval to Construct for the construction of a new outdoor pool, a site inspection shall be made by a representative of the Division in order to confirm that the pool location meets the requirements of Section 3.4. After a specific site is approved, any change of location shall require another site inspection.

4.1.2 Pre-Operational Plan Review Inspection – A pre-operational plan review inspection will occur prior to an Environmental Health Inspection, and will be conducted by representatives of the Division in order to confirm that the pool meets the requirements of Section 3.4 for operation. This inspection will be posted in a location conspicuous to the public until an Environmental Health Inspection has been conducted.

4.1.3 Right of Entry and Environmental Health Inspection - Representatives of the Division shall have the right of immediate entry any time a pool is open, and in special situations, at any reasonable time, in order to perform any inspection to determine compliance with these Regulations. An inspection shall be conducted at least once per year at every active pool. These inspections may include any room or area associated with the pool operation. In addition, the representatives shall be permitted to examine any pertinent records.

4.2 Posting Inspection Results

4.2.1 The results of the most recent inspection of the public pool shall be posted in a location conspicuous to the public.

4.3 Division Personnel Competency Requirement

4.3.1 Division personnel performing environmental health/sanitary evaluations or complaint investigations of public pool shall meet the same requirements as specified for a qualified pool operator in Section 4.4 of these Regulations prior to assuming responsibilities for this program.

4.4 Qualified Operator

4.4.1 The operation of every pool shall be monitored by a qualified operator. This person may be part of the pool staff or from a private company and shall monitor the pool weekly or more as necessary to maintain compliance with these Regulations. Weekly visits shall be documented and available for review by the Division.

4.4.2 The qualified operator’s certificate issued by the Division, or a copy, shall be available for viewing by any patron or representative of the Division upon request.

4.4.3 The Division reserves the right to revoke the approval of any operator based upon evidence of malfeasance or non-feasance.

**History**
- *19 DE Reg. 309 (10/01/15)*

##### **16 Del. Admin. Code § 4464-5.0** Operational Requirements {#sec-4464-5.0 omnilex-key=us-de-regs-official--title-16--4464-5.0}

5.1 Requirements for the Premises

5.1.1 Location

5.1.1.1 Pools shall not be located in areas which are subject to contamination from dust, soot, fly ash, smoke, improper drainage, a high water table, or other undesirable substances.

5.1.1.2 For outdoor pools, any overhead wiring not inside an electrical conduit shall not pass over any part of the deck or an area within twenty (20) feet of the nearest edge of the pool. If the edge of a pool, extended upward vertically, is located within fifteen (15) feet of a building, building roof or balcony, a protective barrier may be required (discretion of the Division) to prevent diving from the building, roof or balcony.

5.1.2 Design

5.1.2.1 No limits are specified for the shape of pools, however, consideration shall be given to shape from the standpoint of safety and proper water circulation.

5.1.2.2 Pools shall be designed such that: there is even and complete water circulation throughout; safe, sanitary conditions can be maintained at all times; all bathers can be effectively monitored.

5.1.2.3 There shall be no protrusions, extensions, means of entanglement, or other obstructions in the pool which can cause entrapment or injury.

5.1.2.4 Underwater or overhead projections or obstructions except for handholds, steps, ladders, facilities for persons with disabilities or recirculation system fittings shall be prohibited, unless such construction can be justified by engineering design.

5.1.2.5 Underwater seat benches may be permitted in areas where the water depth is five (5) feet or less provided that: the maximum water depth over the seat bench is twenty-four (24) inches;

5.1.2.5.1 the seat bench is completely recessed; the outer edge of the seat bench shall be outlined in contrasting color by a solid marking line at least one (1) inch wide; and

5.1.2.5.2 The seat bench surface is slip resistant.

5.1.3 Construction

5.1.3.1 Pool walls and bottoms shall be constructed of concrete, fiberglass, metal or other nontoxic, impervious and structurally rigid materials approved by the Division, which will provide a watertight basin, smooth, easily cleanable surfaces and a finish without cracks.

5.1.3.2 Sand, earth or wood construction shall be prohibited. The walls and bottom shall be white or light in color for the purpose of insuring contrast to identify objects.

5.1.3.3 Corners formed by the intersections of walls or walls and floors shall be curved (radiused).

5.1.3.4 Surfaces within the pool intended to provide footing for patrons shall be designed to be slip resistant.

5.1.3.5 Offset or safety ledges shall be prohibited.

5.1.4 Walls

5.1.4.1 All pool walls shall be vertical for a minimum depth of two (2) feet six (6) inches in areas less than five (5) feet deep.

5.1.4.2 Exceptions may be made for irregularly shaped pools (e.g. zero depth entry, T, L or Z shapes) in the recessed areas out of the main swimming area.

5.1.5 Floor/Slope

5.1.5.1 All pool floors shall be sloped toward the outlet/drain and all slopes shall be constant.

5.1.5.2 The slope shall not exceed one (1) foot in twelve (12) feet (1':12') where the water depth is five (5) feet or less, shall not exceed one (1) foot in three (3) feet (1':3') where the depth is greater than five (5) feet.

5.1.5.3 Any pool having a transition from the slope in the shallow end to the deep end shall do so through a slope break starting at a depth not less than three and one half (3 1/2) feet and not greater than five (5) feet.

5.1.5.4 At least one (1) foot and not more than two (2) feet on the shallow side of the slope break directly under the safety line, the floor shall be marked with a line of contrasting color that is either: solid and at least two (2) inches wide or intermittent with sections that are at least four (4) inches by four (4) inches and not more than one (1) foot apart on centers.

5.1.6 Shallow End Minimum/Maximum Depth

5.1.6.1 With the exception of diving pools, all pools shall have a minimum depth in the shallow area of three (3) feet and a maximum depth of four (4) feet.

5.1.6.2 Exceptions may be made for irregularly shaped pools (e.g. T, L or Z shapes) with recessed areas out of the main swimming area.

5.1.7 Ladders and Steps

5.1.7.1 All pools shall have at least two entry/exit points (ladders or steps), one (1) for each end.

5.1.7.1.1 Wading and treatment pools may have one entry / exit point (ladders or steps).

5.1.7.2 Any pool with water deeper than five (5) feet shall have at least two (2) ladders in the deep end.

5.1.7.3 Any pool with a perimeter greater than two hundred twenty-five (225) feet shall have one (1) additional ladder or set of steps for each additional seventy-five (75) feet of perimeter or fraction thereof.

5.1.7.4 Ladders shall be constructed of corrosion resistant materials and shall be securely anchored into the pool deck or built into the pool wall.

5.1.7.4.1 All ladders shall have two (2) handrails and at least two (2) slip resistant treads which are at least one and one half (1 1/2) inches deep, with a uniform length of at least twelve (12) inches and a uniform spacing of at least seven (7) inches and not more than twelve (12) inches. The clearance between any ladder and the pool wall shall be at least three (3) inches and not more than six (6) inches.

5.1.7.4.2 Recessed ladders (built into the wall) shall have two (2) handrails and shall have a tread at least five (5) inches in depth, at least twelve (12) inches in width and the uppermost tread shall be within twelve inches of the pool coping top edge or the deck surface.

5.1.7.4.3 All treads shall slope toward the pool.

5.1.7.5 Where steps are provided, they shall either be recessed or located in a corner.

5.1.7.5.1 All steps shall have a minimum tread length of twenty-four (24) inches, a tread depth of at least ten (10) inches and a uniform height of not more than twelve (12) inches, with the exception of either the top or bottom tread which may vary + two (2) inches.

5.1.7.5.2 The top surface edge of each step shall be outlined in contrasting color by a line (painted, tile, etc.) at least one (1) inch wide. Each set of steps shall have at least one (1) handrail per seven (7) feet of tread length.

5.1.7.5.3 If the steps are less than four (4) feet wide the handrail shall be located at the side and if the steps are four (4) feet wide or wider, the handrail shall be located in the center.

5.1.7.5.4 The tread surface shall be slip resistant.

5.1.8 Decks and Walkways

5.1.8.1 Every pool shall have a continuous unobstructed deck at rim level around the entire perimeter.

5.1.8.2 The deck shall be no less than four (4) feet wide at any point, measured from the pool edge.

5.1.8.3 For outdoor pools, the area of the deck shall be at least equal to the area of the pool water surface, and for indoor pools, the area of the deck shall be at least equal to two thirds (2/3) of the pool water surface.

5.1.8.4 A minimum width of four (4) feet shall be provided behind lifeguard stands and the ladders/steps of all diving boards.

5.1.8.5 Walkways shall be provided from the deck to all pool sanitary and bathhouse facilities.

5.1.8.6 In computing the minimum deck area for adjacent pools, no area of the deck shall be considered as serving both pools.

5.1.9 Standing water

5.1.9.1 To prevent standing water, decks and walkways shall have a uniform slope of not less than one quarter (1/4) inch per foot and not more than one half (1/2) inch per foot, away from the pool and toward deck drains or areas where the water will have a free unobstructed flow to points of disposal.

5.1.9.2 The edge of the pool deck at its junction with the pool wall shall be constructed of bullnose coping, or some other acceptable material, which will provide an adequate hand hold around the entire pool perimeter and which is not more than twelve (12) inches above the normal water level.

5.1.10 Wet deck/walkway areas

5.1.10.1 Shall be constructed of concrete or other approved material which has an impervious slip resistant surface, can be easily cleaned and is installed such that there are no hazards to patrons or their bare feet (e.g. tripping, abrasions, splinters, etc.).

5.1.10.2 If expansion joints are provided, the joint shall be filled with a non-rigid material such as mastic which shall not protrude above the deck. Exposed wooden expansion joints shall be prohibited.

5.1.10.3 Carpeting shall be prohibited in wet deck/walkway areas.

5.1.11 Electrical and Lighting Requirements

5.1.11.1 All electrical wiring and equipment associated with the pool shall be in compliance with all appropriate state and local codes and the current edition of the National Electric Code.

5.1.11.2 For indoor pools and all bathhouse facilities, all overhead wiring which is not behind the wall or ceiling shall be inside an electrical conduit.

5.1.12 Artificial lighting

5.1.12.1 Shall be provided at all pools which do not have adequate natural lighting or which are to be used for evening/night swimming. The artificial lighting shall meet all of the following conditions:

5.1.12.1.1 Lighting shall be sufficient such that all areas of the pool, and either of the following are clearly visible without glare from the deck: the main drain(s) and all bottom markings; or a black disk six (6) inches in diameter superimposed upon a white field and placed on the bottom at the deepest point.

5.1.12.1.2 Outdoor pools shall provide at least thirty (30) foot candles and indoor pools shall provide at least fifty (50) foot candles of illumination at the water surface from natural and/or artificial lighting.

5.1.12.1.3 All overhead lights shall be covered with adequate shatter resistant shields and equipped with shatter resistant bulbs.

5.1.13 Hose Bibbs

5.1.13.1 A sufficient number of hose bibs shall be provided and located such that all parts of the deck area, the pump/filter room and the bathhouse facilities are easily reachable with a fifty (50) foot hose, without the hose passing over or through the pool water.

5.1.13.2 Hose bibs shall be located at the edge of the deck such that they do not constitute a tripping hazard and shall be equipped with vacuum breakers or other approved backflow prevention devices.

5.1.14 Trees, Sand Areas and Planted Areas

5.1.14.1 Trees at the pool site prior to construction shall not be permitted inside the pool fence. Sand areas and other nongrass / unsodded areas designed for bather access shall not be permitted inside the pool fence or room.

5.1.14.2 Provisions shall be made so that bathers returning to the pool deck from these areas are routed past a foot rinse shower.

5.1.14.3 Flower beds, shrubs and other similar planted areas may be permitted inside the pool fence or room if all of the following conditions are satisfied:

5.1.14.3.1 There shall be a separation distance of at least ten (10) feet between the edge of the pool and the edge of the planted area

5.1.14.3.2 The planted area shall be designed such that regular maintenance can be easily accomplished

5.1.14.3.3 All planted area drainage shall be conducted away from the pool in a manner that will not create muddy, hazardous, or objectionable conditions.

5.1.14.3.4 The planted area shall be designed to discourage patron entry.

5.1.15 Sanitary/Bathhouse Facilities

5.1.15.1 All pools shall have at least one (1) permanent water closet with lavatory for the lifeguard\attendant, which is accessible when the pool is open and is located contiguous to the pool deck or pool room.

5.1.15.2 All pools, with the exception of those where all patrons’ sanitary/bathhouse facilities are within one thousand (1000) feet, shall provide the following permanent sanitary/bathhouse facilities located contiguous to the pool deck or pool room:

5.1.15.2.1 One fixture set for each sex when the pool(s) water surface area is up to 2000 square feet

5.1.15.2.2 Two fixture sets for each sex when the pool(s) water surface is over 2000 to 4000 square feet.

5.1.15.2.3 Three fixture sets for each sex when the pool(s) water surface is over 4000 to 6000 square feet.

5.1.15.2.4 Four fixture sets for each sex when the pool(s) water surface is over 6000 to 8000 square feet.

5.1.15.2.5 For pools greater than eight thousand (8000) square feet, one additional fixture set for each sex shall be provided for each additional four thousand (4000) square feet, or fraction thereof.

5.1.16 Bathhouse facilities

5.1.16.1 All sanitary and bathhouse facilities shall be indoors, enclosed to provide privacy, finished in light colors, well ventilated, in good working order and designed such that good sanitation can be maintained throughout at all times.

5.1.16.2 Floors shall constructed of concrete or other approved material, shall have a smooth slip resistant finish and shall be sloped to floor drains or points of drainage.

5.1.16.3 Carpeting shall be prohibited in all wet deck/walkway areas.

5.1.16.4 Floor and wall junctions shall be curved radius for easy cleaning.

5.1.16.5 Lighting shall provide at least thirty (30) foot candles of illumination at floor level.

5.1.16.6 All lavatories and showers shall have hot and cold water and shall be equipped with tempering valves which provide water at a temperature not exceeding 120 degrees F.

5.1.16.7 All bathhouses shall have soap (liquid recommended), single service towels or hot air dryers, toilet tissue, and waste baskets.

5.1.16.8 All plumbing shall be in compliance with the “State of Delaware Regulations Governing a Detailed Plumbing Code” and new installations shall be inspected and approved by the appropriate authority prior to use.

5.1.16.9 All bathhouse facilities shall be at the same elevation as the pool deck or at an elevation that is accessible with a ramp having a slope that shall not exceed one (1) inch per foot and should not exceed one (1) inch per twenty (20) inches.

5.1.17 Diaper Changing Station

5.1.17.1 All public pools allowing use by diaper-aged bathers shall, upon adoption of this Regulation, have at least one diaper changing station in each male and female bathhouse.

5.1.17.2 An adjacent hand wash sink shall be installed and operational

5.1.17.3 Diaper changing units shall conform to either of the following standards:

5.1.17.3.1 ASTM standard F2285-04: Consumer Performance Standards for Commercial Diaper-Changing Stations, or

5.1.17.3.2 The standards for diaper-changing surfaces in the most current version of Caring for Our Children: National Health and Safety Performance Standards: Guidelines for Out-of-Home Child Care Programs.

5.1.17.4 A covered, hands-free, plastic-lined trash receptacle or diaper pail shall be located directly adjacent to the diaper changing unit.

5.1.17.5 An EPA-registered disinfectant shall be provided for maintaining a clean and disinfected diaper changing unit surface before and after each use.

5.1.18 Foot Rinse Shower

5.1.18.1 All outdoor pools, except those where bathers must go through the bathhouse in order to reach the deck, shall have a foot rinse shower at each patron entry point.

5.1.18.2 Any indoor pool with direct bather access to an outdoor sand beach or other unsodded area shall also have a foot rinse shower at the access point. The foot rinse shower shall be located such that bathers must walk past the deck discharge area.

5.1.18.3 In order to prevent standing water, the deck discharge area shall slope toward a drain or an area where the water will have a free unobstructed flow to points of disposal.

5.1.18.4 The foot rinse shower should: be a shower head; be approximately twelve (12) to twenty four (24) inches above the deck; have an automatic shut off valve when released; and point toward the deck at approximately a forty five (45) degree angle.

5.1.18.5 Foot baths (standing water in which patrons rinse their feet) shall be prohibited.

5.1.19 Drinking Fountain

5.1.19.1 At least one (1) sanitary type (guarded angle jet) drinking fountain in good working order shall be provided.

5.1.19.2 The fountain shall be easily accessible and located inside the pool fence.

5.1.19.3 Common drinking cups shall be prohibited.

5.1.20 Food and Beverage Facilities

5.1.20.1 Food and beverage service facilities that are inside the pool fence or room shall not be located within twenty (20) feet of the pool edge. If permitting is required, all such facilities shall be licensed by the Division or the appropriate authority.

5.1.21 Starting Blocks

5.1.21.1 If starting blocks for competitive swimming events are installed, the water depth under the blocks shall be greater than five (5) feet.

5.1.22 Escutcheon Plates

5.1.22.1 All anchor bolts shall be covered by escutcheon plates.

5.1.23 Access for Persons with Disabilities

5.1.23.1 Access for disabled persons shall conform to ADA Standards as approved by the Department of Justice.

5.1.23.2 Facilities designed to accommodate persons with disabilities will be approved within the limits of sound engineering practice and nationally recognized standards.

5.1.24 Swimming Pool Slides

5.1.24.1 The installation of swimming pool slides shall be prohibited.

5.1.25 Diving Area/Diving Pool and Diving Board

5.1.25.1 The dimensions of the diving area/diving pool and the diving board shall be approved by plan review as per Section 3.4.1.

5.1.25.2 Pools with diving boards higher than three (3) meters, and/or pools with diving platforms shall be constructed in accordance with the standards of the FINA, NCAA and USD and these devices shall be labeled “COMPETITIVE DIVING ONLY.”

5.1.25.3 Diving boards shall have guardrails on both sides which are at least thirty (30) inches high and extend from the back end of the board to at least one (1) foot past the pool edge. Diving boards which are greater than one (1) meter high shall have handrails on both sides of the ladder/steps and the spacing between them exceed twelve (12) inches.

5.1.25.4 All diving boards shall be level and shall have slip resistant surfaces. All supports, steps, and railings shall be made of material which is of sufficient strength to handle the anticipated load. Trampoline type diving facilities and rope drops shall be prohibited. With the exception of competitive diving, any adjustable fulcrum diving board shall have the fulcrum locked in the maximum forward position.

5.1.25.5 Any diving board in existence on the effective date of these Regulations (April 15, 1990) that cannot comply with the requirements of this Section by being shortened and/or lowered, should be removed. Also, in order for the replacement of any diving board stand, or the replacement of any diving board stand and diving board to be approved, the pool shall be in compliance with the requirements of this Section.

**History**
- *19 DE Reg. 309 (10/01/15)*

##### **16 Del. Admin. Code § 4464-6.0** Recirculation System – General Requirements {#sec-4464-6.0 omnilex-key=us-de-regs-official--title-16--4464-6.0}

6.1 Recirculation system.

6.1.1 The recirculation system shall consist of, but is not limited to: a pump, a flow measuring device, a removable strainer with spare basket (not required on vacuum filters), a filter with at least one (1) pressure gauge, an automatic disinfectant feeder, piping, deep end floor outlet/drains, a perimeter overflow gutter or surface skimmers, return inlets, valves and other necessary equipment.

6.1.2 The recirculation system shall be designed to provide the maximum allowable turnover times:

6.1.2.1 Maximum Allowable Turnover Times

6.1.2.1.1 Swimming Pools maximum turnover 6 hours or less

6.1.2.1.2 Wading Pools maximum turnover 1 hour or less and shall have a secondary disinfection system

6.1.2.1.3 Spray Pads maximum turnover 1 hour or less and shall have a secondary disinfection system

6.1.2.1.4 Treatment pools maximum turnover 1 hour or less and shall have a secondary disinfection system

6.1.2.1.5 Spa Pool maximum turnover 15 minutes or less

6.1.3 In the pump/filter area, each suction and discharge line shall have a manual control valve capable of regulating flow or shutting off flow completely

6.1.3.1 If the required flow rate is provided collectively by multiple pumps, all of these pumps shall operate by a single control switch.

6.1.3.2 The difference between the minimum required flow rate in gallons per minute (gpm) (based on the type of pool) and the maximum allowable flow rate in gpm (based on the type of filtration) shall be at least ten (10) gpm.

6.2 Recirculation Pump

6.2.1 All recirculation pumps shall be of adequate capacity to provide the required turnover rate, a sufficient backwash rate and sufficient suction for any vacuum fittings.

6.2.2 If the pump or any suction side piping is located above the pool water level, the pump shall be self-priming.

6.2.3 All recirculation pumps shall be equipped with the necessary piping, valves etc. such that pool water can be pumped directly to waste.

6.2.3.1 This line shall terminate above any drain entry point by a distance of at least twice its diameter.

6.2.3.2 For the purpose of confirming or determining the flow rate, all recirculation pumps shall be equipped with pressure gauges on both the suction and pressure side the pump.

6.2.4 Rate of Flow Indicator

6.2.4.1 At least one (1) rate of flow indicator reading in gpm shall be installed after filtration on the pool return line.

6.2.4.2 The indicator shall be easily accessible for viewing, in proper working condition when the pool is open, sized such that the design flow rate is in the mid range of the indicator, and capable of measuring at least fifty (50) per cent more than the design flow rate.

6.2.4.3 The clearance upstream and downstream from the indicator shall comply with the manufacturer’s specifications.

6.2.4.4 In lieu of the above, a pre-set flow control valve with a direct mounted meter kit and conversion chart may be used.

6.2.5 Floor Outlets/Drains

6.2.5.1 All pools shall be provided with at least two (2) floor outlets/drains at the deepest point which: are connected to the recirculation system through the same line; are at least six (6) feet apart at centers (for special designs, as far apart as possible or on different planes); are equipped with a flow control valve(s) near the recirculation pump; have an antivortex cover or a twelve inch by twelve inch (12" x 12") grate or larger; and can completely drain the pool.

6.2.5.2 All drain outlet pipes shall be recessed within the fitting or in a pit and equipped with a cover which can only be removed with a Phillips screwdriver or a special tool. The width and length of slot openings in the cover shall not exceed one half (1/2) inch and one (1) inch respectively.

6.2.6 Perimeter Overflow Gutters and Surface Skimmers

6.2.6.1 All pools shall have either perimeter overflow gutters or surface skimmers (not recommended for pools with a water surface area greater than 2500 square feet) which:

6.2.6.1.1 are capable of conducting one hundred (100) percent of the required flow rate;

6.2.6.1.2 are connected to the recirculation system; have flow control valves near the recirculation pump;

6.2.6.1.3 and effectively remove any floating material.

6.2.6.2 If perimeter overflow gutters are used, they shall be continuous around the pool with a uniform level rim which is not more than twelve (12) inches below the deck and which will provide a suitable handhold.

6.2.6.3 Gutters shall be designed so that the channel is easily accessible for cleaning and presents no entanglement hazard to bathers.

6.2.6.4 If the gutters are recessed, the access opening shall be at least four (4) inches.

6.2.6.5 Gutter drains shall be provided at uniform intervals not to exceed fifteen (15) feet and the gutter shall slope sufficiently to these drains.

6.2.6.6 The design shall ensure that the recirculation pump receive a continuous supply of water at all times either by adequate surge capacity within the gutters or a surge/balancing tank.

6.2.6.7 Any perimeter overflow gutter with a submerged protruding edge, shall have a solid marking line of contrasting color which is at least one (1) inch wide on the top surface edge of the gutter.

6.2.6.8 If surface skimmers are used, they shall be NSF listed and at least two (2) shall be provided.

6.2.6.8.1 For pools that are greater than one thousand (1000) square feet of water surface, one (1) additional skimmer shall be provided for each additional (500) square feet of pool water surface or fraction thereof.

6.2.6.8.2 Skimmers shall be optimally located around the pool perimeter and the recirculation system shall be designed such that the flow through each skimmer is at least twenty (20) gpm.

6.2.6.8.3 All skimmers shall have individual flow controls devices, an equalizer line (except WP pools), an easily removable, cleanable basket or screen and a cover.

6.2.7 Inlets

6.2.7.1 All pools shall have at least four (4) inlets, either on the side walls or on the floor, which are connected to the recirculation system.

6.2.7.1.1 Side wall inlets, with the exception of those built into a gutter, shall discharge at a depth of at least twelve (12) inches below the normal water level.

6.2.7.1.2 The distance between side wall or bottom inlets, measured along the wall or floor surface, shall not exceed twenty (20) feet and the spacing between any floor inlet and the side wall, measured along the surface, shall not exceed ten (10) feet.

6.2.7.1.3 When wall inlets are used, an inlet shall be provided within five (5) feet of each corner and one (1) in each recessed step area.

6.2.7.1.4 The inlets, either by adjustability or by design, shall provide the necessary flow to maintain the required disinfectant residual and chemical quality evenly throughout the pool.

6.2.8 Vacuuming

6.2.8.1 All pools shall have the capability of vacuuming the bottom either through a skimmer, a separate vacuum fitting or a portable vacuum system.

6.2.8.1.1 If a portable vacuum system must be used, it shall be stored on-site when the pool is open.

6.2.8.1.1.1 Vacuuming through a portable vacuum system that is connected to the potable water supply shall be prohibited.

6.2.8.1.1.2 In line and portable vacuum pumps must be equipped with a removable strainer with a spare basket.

6.2.9 Piping

6.2.9.1 Recirculation system piping shall be made of non-toxic material.

6.2.9.2 All plastic piping shall be: labeled with the manufacturer’s name and the NSF logo for potable water; listed in the current NSF “Listing of Plastic Materials, Pipe, Fittings, and Appurtenances for Potable Water and Wastewater, or approved equivalent;” and used/installed in accordance with the manufacturer’s specifications.

6.2.10 Multiport Valves

6.2.10.1 All multiport valves shall be NSF listed.

6.2.11 Pool Water Heaters

6.2.11.1 All gas heaters shall be design-certified by the American Gas Association (AGA) and shall display a rating data plate and the AGA seal.

6.2.11.2 All electric heaters shall be Underwriters Laboratories (UL) approved and shall display the UL seal.

6.2.11.3 All heaters shall have sufficient piping and valves to permit isolation and removal of the heater from the system.

6.2.12 Equipment Access, Freezing Protection and Drainage

6.2.12.1 Easy access shall be provided to all parts of the recirculation system that must be inspected or serviced.

6.2.12.2 All piping and equipment that is subject to freezing shall be provided with an adequate means of draining.

6.2.12.3 At least thirty (30) foot candles of illumination shall be provided around all equipment.

6.2.12.4 In order to prevent standing water, all equipment rooms shall be adequately graded toward floor drains or areas where the water will have a free unobstructed flow to points of disposal.

**History**
- *19 DE Reg. 309 (10/01/15)*

##### **16 Del. Admin. Code § 4464-7.0** Filtration System {#sec-4464-7.0 omnilex-key=us-de-regs-official--title-16--4464-7.0}

7.1 General Requirements - Each pool shall have its own filtration system.

7.1.1 All filters shall bear the manufacturer’s name, the model #, the surface area and the filter shall be NSF listed. All filtration systems shall be sized such that the maximum allowable filtration rates are not exceeded and shall be operated such that the passage of unfiltered water will be prevented.

7.1.2 The filter effluent water shall have a turbidity of one (1) NTU or less.

7.1.3 All filters shall be capable of being totally drained through a manual valve or by disconnecting a union, and all filtration surfaces shall be accessible for inspection, maintenance or replacement.

7.1.4 Filters that require backwashing shall have a pressure gauge(s) for determining the time to backwash, and a site glass for observing the backwash water clarity.

7.1.5 The backwash discharge line shall terminate above the drain entry point by a distance of at least twice its diameter.

7.1.6 All pressure filters shall be equipped with manual or automatic air release valves, or shall be self-purging.

7.1.7 If a manual air release valve is present, specific instructions explaining its use shall be provided and shall be conspicuously posted on or near the filter.

7.1.8 In multiple filter installations filter piping shall be valved such that each filter can be isolated for repairs, while other filters remain in service.

7.2 Rapid Sand Filters

7.2.1 All media shall meet all of the specifications of the filter manufacturer.

7.2.2 In multiple filter installations filter piping shall be valved such that each filter can be individually backwashed.

7.2.3 The filtration rate for rapid sand filters shall not exceed three (3) gpm per square foot of filter area, or the NSF listed flow rate, whichever is less.

7.3 High Rate Sand Filters

7.3.1 All media shall meet all of the specifications of the filter manufacturer.

7.3.2 The filtration rate for high rate sand filters shall not exceed twenty (20) gpm per square foot of filter area, or the NSF listed flow rate, whichever is less.

7.4 Diatomaceous Earth Filters

7.4.1 If diatomaceous earth filters are equipped with a pressure type separation tank, there shall be no manual valves on the effluent line, and the following statement or equivalent shall be conspicuously posted on the top of the separation tank and at the pump control switch “Do not start the pump without opening the manual air release on the separation tank and checking to make sure that the top of the separation tank is securely attached.”

7.4.2 Any manufacturer’s instructions for the proper use of this separation tank shall display either on the top of the separation tank or on the wall nearby. The filtration rate for diatomaceous earth filters shall not exceed two (2) gpm per square foot of filter area, or the NSF listed flow rate, whichever is less.

7.4.3 Diatomaceous earth filters that have an NSF listing for slurry feed shall not exceed a filtration rate of 2.5 gpm per square foot of filter area.

7.5 Cartridge Filters

7.5.1 All pools with cartridge filtration systems shall have at least one (1) spare cartridge for each cartridge in use, which is clean and ready for installation, along with at least one (1) vat which is capable of submerging all of the cartridges from one filter vessel.

7.5.2 Pools with modular media cartridge filtration shall have at least one (1) spare cartridge for each type of cartridge in use, which is clean and ready for installation.

7.5.3 When cartridges become clogged to the extent that cleaning does not restore them, or they become damaged, they shall be discarded.

7.5.4 The filtration rate for cartridge filters shall not exceed three hundred seventy-five one thousandths (.375) gpm per square foot of filter area, or the NSF design listed flow rate, whichever is less.

**History**
- *19 DE Reg. 309 (10/01/15)*

##### **16 Del. Admin. Code § 4464-8.0** Potable Water Supply, Pool Water Quality/testing, Chemicals and Wastewater {#sec-4464-8.0 omnilex-key=us-de-regs-official--title-16--4464-8.0}

8.1 Potable Water Supply

8.1.1 All pools shall have a water supply which:

8.1.1.1 is approved by the Division;

8.1.1.2 is in compliance with the requirements of the “State of Delaware Regulations Governing Public Drinking Water Systems;”

8.1.1.3 and is of adequate capacity to meet peak demands while maintaining at least twenty five (25) pounds per square inch (psi) and not more than one hundred (100) psi at all points in the system.

8.1.2 All drinking fountains shall be in good working order.

8.1.3 Cross connections between the potable water supply and the pool water shall be prohibited.

8.1.4 Hose bibs shall be located such that they do not constitute a tripping hazard and shall be equipped with vacuum breakers or other backflow prevention devices approved by the Division.

8.2 Fillspout

8.2.1 All pools shall have a permanent fillspout which shall be air gapped at least two (2) pipe diameters above the pool rim, or the rim of any vessel or pipe that connects to the pool.

8.2.2 In order to minimize the possibility of creating a tripping hazard, all fillspouts that are on the deck shall be located immediately next to one of the pool ladders, or another approved location.

8.2.3 The portion of the water line passing through a concrete deck shall either be non-plastic piping or shall be inside a metal sleeve.

8.2.4 All pools that have a fillspout that is a potential tripping hazard, shall take whatever steps are appropriate to eliminate the hazard.

8.3 Clarity

8.3.1 The water in all pools shall be sufficiently clear and the lighting shall be sufficient such that all areas of the pool, and either of the following are clearly visible from the deck:

8.3.1.1 the main drain(s) and all bottom markings;

8.3.1.2 or a black disk six (6) inches in diameter superimposed upon a white field and placed on the bottom at the deepest point.

8.3.2 The turbidity of the pool water shall be five tenths (.5) NTU or less.

8.4 Bacteriological Quality

8.4.1 If samples are taken for the heterotrophic plate count test [standard plate count (SPC)], the result shall be less than (<) two hundred (200) colonies per milliliter.

8.4.2 If samples are taken for the total coliform test, when the membrane filtration (MF) technique is used, the result shall be less than (<) one (1) colony per one hundred (100) milliliters of sample,

8.4.3 when the multiple tube fermentation or most probable number (MPN) method is used, none of the confirmed portions shall show the presence of the coliform group [result reported as less than (<) 2.2] and when the presence/absence test is used, the result shall be absent.

8.4.4 Samples shall be taken by, or required by the Division whenever it is deemed necessary. For the purpose of determining compliance with this Section, samples may be considered only if they have been analyzed by the Division or by another approved laboratory.

8.5 Chemical Quality

8.5.1 The chemical quality of pool water shall not cause any irritation to the eyes or skin of bathers and shall be in compliance with the requirements of the “State of Delaware Regulations Governing Public Drinking Water Systems.”

8.5.1.1 The pH shall not be less than 7.2 or greater than 7.8.

8.5.1.2 Any chemical added directly or indirectly to a pool shall be approved by the Division, registered with the U. S. Environmental Protection Agency, used strictly in accordance with the manufacturer’s directions and properly labeled in accordance with the Hazardous Chemical Information Act 16 Del.C. Ch. 24.

8.5.2 Any pool with a documented history of pH level violations shall have an automatic pH adjustment chemical feeder that:

8.5.2.1 is the NSF listed; is approved by the Division;

8.5.2.2 has approved anti-siphon protection; and is wired such that it feeds only when the recirculation pump runs (shall be done on all pools which are in existence on the effective date of these Regulations when either the chemical feeder or recirculation pump are replaced).

8.5.3 The manual addition of approved non-disinfectant chemicals shall be permitted only in special situations (e.g. trying to achieve water balance), which require that the pool be closed.

8.5.3.1 After this manual addition has been completed, the pool shall remain closed for at least one (1) turnover and until such time as the chemical is thoroughly and evenly dispersed throughout the pool.

8.6 Disinfection

8.6.1 All pools shall be disinfected with an approved halogen that imparts an easily measured residual and is fed through an automatic feeder that:

8.6.1.1 is NSF listed; is approved by the Division; has approved anti-siphon protection;

8.6.1.2 is capable of providing a dosage of at least ten (10) ppm for outdoor pools and a dosage of five (5) ppm for indoor pools (shall be done on an existing pool when the disinfectant feeder is replaced);

8.6.1.3 and is wired such that it feeds only when the recirculation pump runs (shall be done on all pools which are in existence on the effective date of these Regulations when either the disinfectant feeder or recirculation pump are replaced).

8.6.2 A flow-through (erosion) feeder shall feed only the disinfectant(s) specified by the manufacturer. All feeders, with the exception of flow-through feeders, shall add the disinfectant downstream from the filter and heater.

8.6.3 All pool disinfectants shall be registered with the U.S. Environmental Protection Agency and approved by the Division.

8.6.4 Manual addition of an approved halogen disinfectant shall be permitted only in special situations (e.g. superchlorination), which require that the pool be closed.

8.6.4.1 After this manual addition has been completed, the pool shall remain closed: for at least one (1) turnover and until such time as the chemical is thoroughly and evenly dispersed throughout the pool;

8.6.4.1.1 and the automatic feeder is operating properly if it was not at the time of the manual addition.

8.6.5 Use of gas chlorine shall be prohibited.

8.6.6 Use of stabilized chlorine (cyanuric acid) in indoor pools shall be prohibited.

8.6.7 In order for any non-halogen to be approved as a stand alone disinfectant, satisfactory performance shall be demonstrated during an NSF evaluation.

8.6.8 All pools shall be disinfected in accordance with the following requirements:

8.6.8.1 Chlorine

8.6.8.1.1 Pools not using Cyanuric Acid minimum 1.0 PPM Free Available Chlorine required

8.6.8.1.2 Pools using Cyanuric Acid minimum 2.0 PPM Free Available Chlorine Required

8.6.8.1.3 Spas minimum 3.0 PPM Free Available Chlorine

8.6.8.1.4 Recommended maximum is 10.0 PPM Free Available Chlorine

8.6.8.2 Bromine

8.6.8.2.1 Pools minimum 3.0 PPM Bromine

8.6.8.2.2 Spas minimum 4.0 PPM Bromine

8.6.8.2.3 Cyanuric Acid should not exceed 100 PPM

8.6.9 Secondary Disinfection Systems

8.6.9.1 General Requirements

8.6.10 ANSI Listing and Labeling - Secondary Disinfection Systems shall be listed and labeled to ANSI/NSF 50 by an ANSI-accredited certification organization approved by the Division.

8.6.10.1 Required Facilities

8.6.10.1.1 The new construction or substantial alteration of the following public pools shall be required to use a secondary disinfection system after adoption of this regulation:

8.6.10.1.2 Pools designed primarily for children under 5 years old, such as

8.6.10.1.2.1 Wading pools

8.6.10.1.2.2 Splash pads with no standing water

8.6.10.1.2.3 Treatment pools

8.6.10.2 3-log Inactivation

8.6.10.2.1 Secondary disinfection system shall be designed to achieve a minimum 3-log (99.9%) reduction in the number of infective Cryptosporidium parvum oocysts per pass through the secondary disinfection system.

8.6.10.3 Installation

8.6.10.3.1 The secondary disinfection system shall be located in the treatment loop (post filtration) and treat a portion (up to 100%) of the filtration flow prior to return of the water to the pool or feature.

8.6.10.3.2 Minimum Flow Rate Calculation The flow rate (Q) through the secondary disinfection system shall be determined based upon the total volume of the pool or feature (V) and a prescribed dilution time (T) for theoretically reducing the number of assumed infective Cryptosporidium (108 oocysts from an initial total number of 100 million) oocysts to a concentration of one oocysts/100 mL.

8.6.10.3.3 Equation Accounting for a 3 log (99.9%) reduction of infective Cryptosporidium oocysts through the secondary disinfection system with each pass, the secondary disinfection system flow rate

8.6.10.3.3.1 (Q) shall be: Q = V x {[14.8 – ln (V)] / (60 x T)}, where:

8.6.10.3.3.1.1 Q = secondary disinfection system flow rate (gpm)

8.6.10.3.3.1.2 V = Total water volume of the pool or feature, including surge tanks, piping, equipment, etc. (gals)

8.6.10.3.3.1.3 T = Dilution time (hrs.)

8.6.10.3.4 Time for Dilution Reduction The dilution time shall be the lesser of nine hours or 75% of the uninterrupted time a pool is closed in a 24 hour period.

8.6.10.3.5 Flow Rate Measurements where a secondary disinfection system is installed, a means shall be installed to confirm the required flow rate to maintain a minimum 3 log (99.9%) reduction of infective Cryptosporidium oocysts at the minimum flow rate.

8.6.11 Water Testing Equipment and Sampling Frequency

8.6.11.1 All pools shall have approved testing equipment for pH, disinfectant residual, alkalinity, and calcium hardness.

8.6.11.2 For disinfectant residual, the DPD (Diethyl-P-Phenylene Diamine) method, or any other method in the current edition of Standard Methods for the Examination of Water and Wastewater, shall be used.

8.6.11.3 If the disinfectant is chlorine, the test kit shall be capable of measuring both free and total chlorine residual.

8.6.11.4 For pH, the phenol red colorimetric method, or any other method in the current edition of Standard Methods for the Examination of Water and Wastewater, shall be used and the test kit shall have a range of at least 6.8-8.2.

8.6.11.5 In addition to these parameters, pools that use a stabilized halogen shall have approved cyanuric acid testing equipment.

8.6.11.6 All chemical test kit reagents shall be dated when received, and shall be replaced just prior to the start of each outdoor pool season, and at least yearly for indoor pools, with the exception of phenol red which shall be replaced at least every six (6) months.

8.6.11.6.1 pH and disinfectant residual shall be measured daily, prior to the pool opening, and as often as necessary while the pool is open (recommended every one (1) to two (2) hours) in order to ensure the proper levels.

8.6.11.6.2 Alkalinity, calcium hardness and cyanuric acid (if applicable) shall be measured after each addition of makeup water and at least weekly.

8.6.12 All sample results shall be recorded along with the date, time and sample location (area of the pool).

8.6.13 Records of sample results shall be kept at the pool for at least one (1) year, shall be available for viewing by any representative of the Division during an inspection and shall be submitted to the Division upon request.

8.6.14 If any other substance is added to the pool on a regular basis (e.g. copper/silver from a supplemental disinfection system), the Division may require testing to ensure that the concentrations do not exceed acceptable levels.

8.7 Pool Water Level and Recirculation System

8.7.1 When the pool is open, the pool water level shall be maintained at an elevation suitable for continuous flow into the surface skimmers or intermittent flow into the gutter as bathers enter.

8.7.2 The recirculation system shall operate continuously (24 hours per day), with the exception of the automatic disinfectant feeder when the disinfectant level approaches or exceeds the upper recommended level.

8.7.3 All pools shall have the capability of pumping water to waste either directly or via filter backwash.

8.7.4 The Division may require a dye test to ensure that the recirculation system is providing even and complete recirculation throughout the pool.

8.8 Chemical Storage

8.8.1 All chemicals, including test kits, shall be stored in accordance with the storage recommendations on the manufacturer’s label and the MSDS, and they shall be stored in areas that are not easily accessible to bathers or other unauthorized personnel.

8.8.2 All pools shall keep adequate quantities of chemicals on hand such that shortages are not experienced.

8.8.3 “NO SMOKING” signs shall be conspicuously posted in all chemical storage areas.

8.9 Wastewater Disposal

8.9.1 Cross connections between the pool recirculation system and any wastewater system, including the filter backwash drain, shall be prohibited.

8.9.2 The backwash discharge line shall terminate above the drain entry point by a distance of at least twice its diameter.

**History**
- *19 DE Reg. 309 (10/01/15)*

##### **16 Del. Admin. Code § 4464-9.0** Operation, Maintenance, General Sanitation, Personnel, Supervision and Safety {#sec-4464-9.0 omnilex-key=us-de-regs-official--title-16--4464-9.0}

9.1 Operation and Maintenance

9.1.1 All pools, their premises, and appurtenances, shall be operated and maintained at all times with regard to the safety of bathers and employees.

9.1.2 All plumbing shall be properly installed and maintained.

9.1.3 During an electrical storm, use of any pool (indoor or outdoor) shall be prohibited.

9.1.4 Alcoholic beverages shall be prohibited in the pool and on the pool deck.

9.1.5 Food and beverages shall be prohibited in the pool and within four (4) feet of the pool edge.

9.1.6 Glass or other breakable containers, utensils, etc. shall be prohibited within the pool fence, pool room or bathhouse facilities.

9.1.7 Pool walls and floors shall be refinished when safe sanitary conditions cannot be maintained.

9.1.8 Any deck/walkway areas that are hazardous to patrons or their bare feet (e.g. tripping, abrasions, splinters, etc.) or do not properly drain, shall be repaired or replaced such that the hazard or drainage problem is eliminated.

9.1.9 Any electrical hazard shall be eliminated.

9.1.10 All pools which have a slope break, shall install a line of contrasting color one (1) to two (2) feet on the shallow side of the break directly under the safety line that is either: solid and at least two (2) inches wide or intermittent with sections that are at least four (4) inches by four (4) inches and not more than one (1) foot apart on centers.

9.1.11 All pools which have steps or benches, shall install a solid marking line of contrasting color which is at least one (1) inch wide on the top surface edge of each pool step or bench.

9.1.12 All pools which have any type of overflow gutter or a safety ledge with a submerged protruding edge, shall install a solid marking line of contrasting color which is at least one (1) inch wide on the top surface edge of the gutter.

9.2 General Sanitation and Sanitary Facilities

9.2.1 All pools and related facilities shall be maintained in a clean sanitary condition.

9.2.2 The pool floor, walls, deck, walkways and bathhouse facilities shall be cleaned and disinfected with an approved disinfectant as often as necessary in order to maintain an environment which is free of sediment, dirt, algae, grass/weeds and foreign objects.

9.2.3 All garbage shall be stored in containers which are sufficient in number and properly covered so as not to attract vermin.

9.2.4 Effective control measures shall be utilized to minimize or eliminate the presence of rodents, flies, roaches or other vermin.

9.2.5 All pools shall have at least one (1) permanent or portable water closet for the lifeguard/attendant, which is accessible when the pool is open and is located such that the path of travel from the nearest pool entrance/exit does not exceed five hundred (500) feet.

9.2.5.1 If a portable water closet is provided, it shall be properly vented, designed to exclude flies, equipped with a self-closing door, provided with toilet tissue and maintained in a clean sanitary condition and be located contiguous to the pool deck or pool room.

9.3 Animals

9.3.1 With the exception of guide / service animals for persons with disabilities, animals shall be prohibited within the pool fence, pool room or bathhouse facilities.

9.4 Bathing Suits

9.4.1 It is recommended that all bathers should wear bathing suits. A bathing suit is a garment designed for that purpose which covers the buttocks (male and female) and breasts (female).

9.4.2 If anyone who is not toilet trained is going to use a pool, the operator shall take whatever steps are necessary to ensure that fecal material does not enter the water (e.g. requiring the use of a swimsuit diaper).

9.4.3 Should fecal material enter any pool, the pool shall be closed immediately and the operator shall follow Division procedures for reopening.

9.5 Bather Health

9.5.1 Any person with evidence of an open sore, a bandaged wound or diarrhea shall be prohibited from entering the pool water. Any person suspected of being under the influence of alcohol or drugs shall be prohibited from entering the pool.

9.6 Lifeguard

9.6.1 Unless exempted by 16 Del.C., each pool that is greater than four (4) feet deep (any portion) shall have a lifeguard on duty when the pool is open.

9.6.2 If a lifeguard who is working alone must leave poolside, for whatever reason, he/she shall take whatever steps are necessary to ensure that no one remains in or enters the water in his/her absence.

9.6.3 Copies of training/certification documentation for all lifeguards currently employed by the pool’s management shall be present at the pool when it is open.

9.6.4 No person shall serve as a lifeguard unless he or she meets all of the following training requirements and can produce the appropriate documentation upon request of the Division:

9.6.4.1 Current certification in National YMCA Lifeguarding, or American Red Cross Basic Lifeguarding, Ellis and Associates International Lifeguard Training Program, Aquatic Resource Service Associates Aquatic Rescue Training or approved equivalent.

9.6.4.2 Current certification in American Red Cross, American Heart Association, or National Safety Council (NSC) Cardiopulmonary Resuscitation (CPR), or approved equivalent, that includes training in: one (1) person adult CPR, child CPR and infant CPR.

9.6.4.3 Current certification in American Red Cross Standard First Aid, or approved equivalent, that includes training in: obstructed airway, artificial breathing, control of bleeding, and treatment for shock.

9.7 Attendant

9.7.1 If none of the pools at a facility require a lifeguard based on depth, each pool, with the exception of those exempted by 16 Del.C., shall have an attendant on duty when the pool is open.

9.7.2 If an attendant who is working alone must leave poolside, for whatever reason, he/she shall take whatever steps are necessary to ensure that no one remains in or enters the water in his/her absence.

9.7.3 In facilities with a spa pool(s) only, if the attendant is not in direct view of the pool, he/she shall be located such that the poolside alarm required by Section 9.19. can be easily heard.

9.7.4 Copies of training/certification documentation for all attendants currently employed by the pool’s management shall be present at the pool when it is open.

9.7.5 No person shall serve as an attendant unless he or she meets all of the following training requirements and can produce the appropriate documentation upon request of the Division:

9.7.5.1 Current certification in American Red Cross, American Heart Association or NSC Cardiopulmonary Resuscitation (CPR), or approved equivalent that includes training in: one person adult CPR, child CPR and infant CPR.

9.7.5.2 Current certification in American Red Cross Standard First Aid, or approved equivalent, that includes training in: obstructed airway, artificial breathing, control of bleeding, and treatment for shock.

9.8 Lifeguard Warning Sign

9.8.1 Any exempted pool or any pool with a maximum depth of four (4) feet that does not have a lifeguard or attendant on duty shall conspicuously post the following sign at the pool entrance(s) and at least one (1) other location inside the pool room/fence:

9.8.1.1 “WARNING NO LIFEGUARD ON DUTY” in letters at least four (4) inches high along with “CHILDREN UNDER THE AGE OF SIXTEEN (16) SHOULD BE ACCOMPANIED BY A PARENT OR GUARDIAN” in letters at least one (1) inch high. (NOTE -A guardian is an adult designated by a parent who is responsible for the children and their behavior)

9.9 Lifeguard Stand

9.9.1 All pools with a water surface area greater than two thousand (2000) square feet shall have at least one (1) lifeguard stand.

9.9.2 The lifeguard stand shall be at poolside, however, no part of the stand shall extend past the edge of the pool.

9.10 Unsupervised Solo Bathing - Unsupervised solo bathing shall be prohibited at all pools with the exception of those exempted by 16 Del.C.

9.11 Injury, Resuscitation or Death

9.11.1 The Division shall be notified within twenty-four (24) hours of any incident at a pool which:

9.11.1.1 requires referral to a hospital, doctor or other facility for medical attention;

9.11.1.2 requires resuscitation;

9.11.1.3 or results in death.

9.11.2 The notification shall be followed up by a written report within thirty (30) days which contains all pertinent details of the incident.

9.12 Pool Security

9.12.1 All entrances to indoor pools shall be equipped with locks and each entrance shall be locked when the pool is closed.

9.12.2 All outdoor pools shall be enclosed by a fence which provides a barrier that is at least four (4) feet high everywhere [six (6) feet recommended], measured from ground level outside the fence.

9.12.3 All pool fences shall be equipped with a locking gate which shall be locked when the pool is closed.

9.13 Depth Markings

9.13.1 With the exception of wading pools and spa pools, the water depth of all pools, in feet to the nearest one half (1/2) foot, shall be plainly marked at or above the water surface on the vertical pool wall, and on the coping or deck within eighteen (18) inches of the pool edge.

9.13.1.1 For pools with open gutters, the depth marking required on the vertical pool wall may be located on the wall of the room for indoor pools, and on the fence for outdoor pools.

9.13.2 These pairs of depth markings shall be located at the points of minimum depth, maximum depth, intermediate depths at no more than two (2) foot depth increments, breaks in slope and on each end of the pool.

9.13.3 All depth markings shall be at least four (4) inches high, of a contrasting color and spaced no more than twenty-five (25) feet apart on the pool perimeter.

9.13.4 Markings on the pool walls shall be positioned to be read from the water. Markings on the deck shall be positioned to be read while standing on the deck and facing the pool and shall be slip resistant.

9.14 Safety Line

9.14.1 Whenever non-swimmers are in the water, all pools that have a slope break shall have a safety line located at least one (1) foot and not more than two (2) feet on the shallow side of the slope break, directly above the line on the bottom required by Section 5.1.

9.14.2 The safety line shall have clearly visible colored floats spaced not more than five (5) feet apart. The safety line shall be of sufficient size and strength to provide a handhold which will support any bather who is in need of help and the connections to the pool wall shall be recessed.

9.15 Safety Equipment - All pools shall have the following safety equipment which shall be easily accessible:

9.15.1 A telephone,

9.15.1.1 Each facility shall have a functional telephone or other communication device that is hard wired and capable of directly dialing 911 or function as the emergency notification system.

9.15.1.2 The telephone or communication system or device shall be conspicuously provided and accessible to aquatic venue users such that it can be reached immediately.

9.15.1.3 Alternate functional systems, devices, or communication processes are allowed with AHJ approval in situations when a hardwired telephone is not logistically sound, and an alternate means of communication is available.

9.15.1.4 A permanent sign providing emergency dialing directions and the aquatic facility address shall be posted and maintained at the emergency telephone, system or device.

9.15.2 A first aid kit

9.15.2.1 An adequate supply of first aid supplies shall be continuously stocked and include, at a minimum, as follows:

9.15.2.1.1 A First Aid Guide,

9.15.2.1.2 Absorbent compress,

9.15.2.1.3 Adhesive bandages,

9.15.2.1.4 Adhesive tape,

9.15.2.1.5 Sterile pads,

9.15.2.1.6 Disposable gloves,

9.15.2.1.7 Scissors,

9.15.2.1.8 Elastic wrap,

9.15.2.1.9 Two Emergency blankets,

9.15.2.1.10 Resuscitation mask with one-way valve, and

9.15.2.1.11 Blood borne pathogen spill kit.

9.15.2.2 The public pool shall have designated locations for emergency and first aid equipment.

9.15.3 Signage – shall be provided at the aquatic facility or each aquatic venue, as necessary, which clearly identifies the following:

9.15.3.1 Sign Indicating First Aid Location

9.15.3.1.1 First aid location(s), and

9.15.3.1.2 Emergency telephone(s) or approved communication system or device.

9.15.3.2 Emergency Dialing Instructions

9.15.3.2.1 A permanent sign providing emergency dialing directions and the aquatic facility address shall be posted and maintained at the emergency telephone, system or device.

9.15.3.3 Management Contact Info

9.15.3.3.1 A permanent sign shall be conspicuously posted and maintained displaying contact information for emergency personnel and aquatic facility management.

9.15.3.4 Hours of Operation

9.15.3.4.1 A sign shall be posted stating the following:

9.15.3.4.1.1 The operating hours of the aquatic facility, and

9.15.3.4.1.2 Unauthorized use of the aquatic facility outside of these hours is prohibited.

9.15.4 In addition to the above, all pools without a lifeguard on duty (those exempted by 16 Del.C.) shall also be equipped with the following safety equipment which shall be and easily accessible:

9.15.4.1 One (1) or more lightweight poles at least twelve (12) and not more than fifteen (15) feet long, and equipped with a shepherd’s hook.

9.15.4.2 One ring buoy at least eighteen (18) to twenty-four (24) inches in diameter attached to at least fifty (50) feet of rope.

9.15.4.3 In addition to the above, all pools with a lifeguard on duty shall also be equipped with the following safety equipment that shall be made easily accessible:

9.15.4.4 One rigid backboard (long board) with at least three (3) attached ties/straps which is compatible for transport in the Delaware State Police MED-E-VAC helicopter, meets the design requirements of Emergency Medical Services, and is approved by the Division. Six (6) attached ties/straps are recommended.

9.15.4.4.1 If a pool, because of size, will not accommodate a long board being placed under a bather, a reduced backboard (short board) with at least one (1) tie/strap may be substituted.

9.15.4.4.2 Current specification requirements for backboards are available upon request from the Division. (NOTE - This is not required for exempted pools that operate without a lifeguard).

9.15.4.5 In place of a ring buoy, at least one (1) rescue tube for each lifeguard on duty.

9.16 Diving

9.16.1 With the exception of official competition or when there is qualified instruction, diving shall be prohibited into water that is five (5) feet deep or less.

9.16.2 At Swimming and water slide flume pools, all areas where the water is five (5) feet deep or less shall be clearly labeled “No Diving” on the coping (edge of the deck).

9.16.3 The “No Diving” markings shall be: of a contrasting color; easily readable;, slip resistant and at least four (4) inches high consisting of the words “No Diving,” the words “No Diving” in combination with the picture (international) sign (diver inside a red circle with a red line across), or other approved markings.

9.16.4 The number of markings shall be at least equal to the number of depth markings within the “No Diving Area”.

9.17 Shallow End Starting Blocks

9.17.1 Shallow end starting blocks (water depth that is five (5) feet or less) shall be removed when there is no official competition, instruction or practice.

9.17.2 Shallow end starting blocks that are not removable shall be labeled “starting blocks shall be used only during official competition or when there is qualified instruction.”

9.18 Wading Pool Supervision

9.18.1 It is recommended that all children using a wading pool be supervised by a responsible person who is at least sixteen (16) years of age.

9.19 Attendant Alarm

9.19.1 Any spa pool, with the exception of those at facilities exempted by 16 Del.C., which is located such that it is not in direct view of the attendant shall have, in the immediate vicinity of the pool, a clearly labeled alarm device that can be activated when a bather is in trouble and is easily heard throughout the area or building.

9.19.2 This alarm shall produce a distinctly different sound than that of the high temperature alarm.

9.20 Spa Pool Warning Sign

9.20.1 A clearly visible sign shall be mounted at the entrance of each Spa pool facility or adjacent to each spa pool and shall include, but is not limited to, the following:

9.20.1.1 All bathers should take a shower prior to entering.

9.20.1.2 Enter and exit slowly and cautiously.

9.20.1.3 Unsupervised solo bathing is prohibited.

9.20.1.4 Use by anyone under five (5) years of age is prohibited unless there is documented written permission from their physician.

9.20.1.5 Elderly persons and anyone with heart disease, diabetes, high or low blood pressure, or anyone under a physician’s care should not enter without consulting with their physician.

9.20.1.6 Pregnant women should not enter unless the temperature is less than 102oF.

9.20.1.7 Hot water immersion while under the influence of, anticoagulants, antihistamines, vasoconstrictors, vasodilators, stimulants, hypnotics, narcotics or tranquilizers may be hazardous to your health and is prohibited.

9.20.1.8 Observe a fifteen (15) minute time limit, then shower, cool down and return if you wish. Longer exposures to this water may result in nausea, dizziness or fainting.

9.20.1.9 Do not submerge to the bottom of the pool, hair may become entangled in bottom outlet. Long hair should be tied in a knot or a bun in order to keep it out of the water.

9.20.1.10 No body lotions or oils are permitted.

9.21 Spa Pool Timer Switch

9.21.1 All Spa pools shall have a clearly labeled reversible aeration/jetting system timer switch with a fifteen (15) minute time limit located in the pool area but such that it cannot be reset from within the pool.

9.22 Spa Pool Temperature/High Temperature Prevention System

9.22.1 The water temperature in spa pools shall not exceed 104oF.

9.22.2 All spa pools shall have a thermometer that is measuring the current water temperature.

9.22.3 If the thermometer is in the pool, it shall be non-glass and tethered.

9.22.4 All spa pools shall be equipped with an approved system that will ensure that the water does not exceed 104oF (e.g. a high temperature alarm, an automatic heater shut off device, etc.) The alarm shall produce a distinctly different sound than that of the attendant alarm.

9.22.5 If there is a documented history of high temperature violations, the high temperature prevention system shall be replaced/upgraded.

9.22.6 The Division may test the high temperature prevention system to ensure proper operation.

9.23 Spa Pool Clock

9.23.1 A clock which is easily readable from the spa pool shall be provided.

9.24 Water Slide Flume-Head of the Flume Personnel

9.24.1 At least one person who meets the training requirements of Section 9.7. shall be stationed at the head of the flume to supervise and control the start of each slider, the spacing of sliders and the monitoring of the downward progress of each slider.

9.25 Water Slide Flume-Splash Pool Attendant

9.25.1 At least one attendant shall be stationed near the end of the flume/run out to supervise and control the sliders as they arrive.

9.25.2 Additional attendants shall be required at the discretion of the Division.

9.26 Ventilation

9.26.1 All bathhouse rooms, equipment rooms, chemical storage rooms and indoor pool rooms shall be provided with adequate natural or mechanical ventilation such that satisfactory indoor air quality is maintained.

9.27 Cartridge Filtration

9.27.1 All pools with cartridge filtration systems shall have at least one (1) spare cartridge for each cartridge in use, which is clean and ready for installation, along with at least one (1) vat which is capable of submerging all of the cartridges from one filter vessel.

9.27.2 Pools with modular media cartridge filtration shall have at least one (1) spare cartridge for each type of cartridge in use, which is clean and ready for installation.

9.27.3 When cartridges become clogged to the extent that cleaning does not restore them, or they become damaged, they shall be discarded.

9.28 Fecal/Vomit/Blood Contamination Response

9.28.1 Contamination Response Plan

9.28.1.1 All public pools shall have a Contamination Response Plan for responding to formed-stool contamination, diarrheal-stool contamination, vomit contamination, and contamination involving blood.

9.28.2 Contamination Training

9.28.2.1 The Contamination Response Plan shall include procedures for response and cleanup, provisions for training staff in these procedures, and a list of equipment and supplies for clean-up.

9.28.2.2 A minimum of one person on-site while the public pool is open for use shall be:

9.28.2.2.1 Trained in the procedures for response to formed-stool contamination, diarrheal contamination, vomit contamination, and blood contamination; and

9.28.2.2.2 Trained in Personal Protective Equipment and other OSHA measures including the Bloodborne Pathogens Standard 29 CFR 1910.1030 to minimize exposure to bodily fluids that may be encountered as employees in an aquatic environment.

9.28.2.3 Informed - Staff shall be informed of any updates to the response plan.

9.28.2.4 Equipment and Supply Verification - The availability of equipment and supplies for remediation procedures shall be verified by the qualified operator at least weekly.

9.28.2.5 Plan Review - The response plan shall be reviewed at least annually and updated as necessary.

9.28.2.6 Plan Availability - The response plan shall be kept on site and available for viewing by the Division.

9.28.3 Aquatic Venue Water Contamination Response

9.28.3.1 Closure - In the event of a fecal or vomit contamination in a public pool, the trained staff shall immediately close the public pool to swimmers until remediation procedures are complete.

9.28.3.2 Closure Includes - This closure shall include the affected Public pool and other public pool venues that share the same recirculation system.

9.28.3.3 Physical Removal - Contaminating material shall be removed (e.g., using a net, scoop, or bucket) and disposed of in a sanitary manner.

9.28.3.4 Clean / Disinfect Net or Scoop

9.28.3.4.1 Fecal or vomit contamination of the item used to remove the contamination (e.g., the net or bucket) shall be removed by thorough cleaning followed by disinfection (e.g., after cleaning, leave the net, scoop, or bucket immersed in the pool during the disinfection procedure prescribed for formed-stool, diarrheal-stool, or vomit contamination, as appropriate).

9.28.3.5 No Vacuum Cleaners

9.28.3.5.1 Aquatic vacuum cleaners shall not be used for removal of contamination from the water or adjacent surfaces unless vacuum waste is discharged to a sanitary sewer and the vacuum equipment can be adequately disinfected.

9.28.3.6 Treated - Public Pool water that has been contaminated by feces or vomit shall be treated as follows:

9.28.3.6.1 Check to ensure that the water’s pH is 7.5 or lower and adjust if necessary;

9.28.3.6.2 Verify and maintain water temperature at 77°F (25°C) or higher;

9.28.3.6.3 Operate the filtration/recirculation system while the POOL reaches and maintains the proper free CHLORINE concentration during the remediation process;

9.28.3.6.3.1 Test the chlorine residual at multiple sampling points to ensure the proper free chlorine concentration is achieved throughout the pool for the entire disinfection time; and

9.28.3.6.3.2 Use only non-stabilized chlorine products to raise the free chlorine levels during the remediation.

9.28.4 Aquatic Venue Water Contamination Disinfection

9.28.4.1 Formed-Stool Contamination

9.28.4.1.1 Formed-stool contaminated water shall have the free chlorine residual checked and the free chlorine residual raised to 2.0 mg/L (if less than 2.0 mg/L) and maintained for at least 25 minutes (or an equivalent time and concentration to reach the CT value) before reopening the public pool.

9.28.4.1.2 Pools Containing Chlorine Stabilizers - In public pool water that contains cyanuric acid or a stabilized chlorine product, water shall be treated by doubling the inactivation time required.

9.28.4.1.3 Measurement of Inactivation Time - Measurement of the inactivation time required shall start when the public pool reaches the intended free Chlorine level.

9.28.4.2 Diarrheal-Stool Contamination

9.28.4.2.1 Diarrheal-stool contaminated water shall:

9.28.4.2.1.1 Check the free chlorine residual and then raise the free chlorine residual to 20.0 mg/L and maintain for at least 12.75 hours (or an equivalent time and concentration to reach the CT value before reopening the public pool, or

9.28.4.2.1.2 Circulate the water through a secondary disinfection system to theoretically reduce the number of Cryptosporidium oocysts in the public pool below one oocyst/100 mL.

9.28.4.3 Pools Containing Chlorine Stabilizers

9.28.4.3.1 In AQUATIC VENUE water that contains cyanuric acid or a stabilized chlorine product, water shall be treated by:

9.28.4.3.1.1 Lowering the pH to 6.5, raising the free chlorine residual to 40 mg/L using a non-stabilized chlorine product, and maintaining at 40 mg/L for at least 30 hours or an equivalent time and concentration needed to reach the CT value. (Measurement of the inactivation time required shall start when the aquatic venue reaches the intended free chlorine level.) or;

9.28.4.3.1.2 Circulating the water through a secondary disinfection system to theoretically reduce the number of Cryptosporidium oocyst in the public pool below one oocyst/100 mL or;

9.28.4.3.1.3 Draining the AQUATIC VENUE completely.

9.28.5 Vomit-Contamination

9.28.5.1 Vomit-contaminated water shall have the free chlorine residual checked and the free chlorine residual raised to 2.0 mg/L (if less than 2.0 mg/L) and maintained for at least 25 minutes (or an equivalent time and concentration to reach the CT VALUE) before reopening the public pool.

9.28.5.2 Pools Containing Chlorine Stabilizers

9.28.5.2.1 In public pool water that contains cyanuric acid or a stabilized chlorine product, water shall be treated by doubling the inactivation time

9.28.5.3 Measurement of the Inactivation Time

9.28.5.3.1 Measurement of the inactivation time required shall start when the public pool reaches the intended free chlorine level.

9.28.6 Blood-Contamination

9.28.6.1 Blood contamination of a properly maintained public pool’s water does not pose a public health risk to swimmers.

9.28.6.2 Operators Choose Treatment Method

9.28.6.2.1 Operators may choose whether or not to close the public pool and treat as a formed stool contamination to satisfy patron concerns.

9.28.7 Procedures for Brominated Pools

9.28.7.1 Formed-stool, diarrheal-stool, or vomit-contaminated water in a brominated public pool shall have chlorine added to the public pool in an amount that will increase the free chlorine residual to the level specified for the specific type of contamination for the specified time.

9.28.7.2 Bromine Residual

9.28.7.2.1 The bromine residual shall be adjusted if necessary before reopening the public pool.

9.28.8 Surface Contamination Cleaning and Disinfection

9.28.8.1 Limit Access - If a bodily fluid, such as feces, vomit, or blood, has contaminated a surface in an public pool, facility staff shall limit access to the affected area until remediation procedures have been completed.

9.28.8.2 Clean Surfaces - Before disinfection, all visible contaminant shall be cleaned and removed with disposable cleaning products effective with regard to type of contaminant present, type of surface to be cleaned, and the location within the facility.

9.28.8.3 Contaminant Removal and Disposal - contaminant removed by cleaning shall be disposed of in a sanitary manner or as required by law.

9.28.8.4 Disinfect Surface - Contaminated surfaces shall be disinfected with one of the following disinfection solution:

9.28.8.4.1 1:10 dilution of fresh household bleach with water; or

9.28.8.4.2 An equivalent EPA Registered disinfectant that has been approved for body fluids disinfection.

9.28.8.5 Soak - The disinfectant shall be left to soak on the affected area for a minimum of 20 minutes or as otherwise indicated on the disinfectant label directions.

9.28.8.6 Remove - Disinfectant shall be removed by cleaning and shall be disposed of in a sanitary manner or as required by the Division.

**History**
- *19 DE Reg. 309 (10/01/15)*

##### **16 Del. Admin. Code § 4464-10.0** Wading Pools {#sec-4464-10.0 omnilex-key=us-de-regs-official--title-16--4464-10.0}

10.1 General Requirements

10.1.1 Except as otherwise noted previously and in this Section, wading pools shall comply with all other requirements of these Regulations.

10.2 Location

10.2.1 Wading pools which are installed in conjunction with a pool shall be located adjacent to the shallowest area of the pool and shall be at least ten (10) feet away.

10.3 Floor/Slope

10.3.1 The slope of a wading pool floor shall not exceed six (6) inches in ten (10) feet (6"/10') and the floor shall be slip resistant.

10.4 Fencing

10.4.1 All wading pools which are indoors or within the confines of another pool fence shall be surrounded by a fence which is at least three (3) feet high and is equipped with a gate.

10.5 Recirculation System

10.5.1 The wading pool recirculation system shall be capable of providing a minimum of twenty-four (24) turnovers of the pool volume per day [one (1) every hour] against the maximum head.

10.6 Perimeter Overflow Gutters and Surface Skimmers

10.6.1 All wading pools shall be equipped with either a perimeter overflow gutter or at least one skimmer which is connected to the recirculation system and effectively remove any floating material.

10.6.2 For wading pools that are greater than five hundred (500) square feet of water surface, one (1) additional skimmer shall be provided for each additional (500) square feet of pool water surface or fraction thereof.

10.7 Inlets

10.7.1 All wading pools shall have at least two (2) inlets and in wading pools where only one (1) skimmer is required, the inlets shall be located such that they direct water toward the skimmer.

10.8 Water Replacement

10.8.1 The entire wading pool water volume should be replaced on at least a weekly basis either by normal backwashing or by pumping directly to waste.

**History**
- *19 DE Reg. 309 (10/01/15)*

##### **16 Del. Admin. Code § 4464-11.0** Spa Pools {#sec-4464-11.0 omnilex-key=us-de-regs-official--title-16--4464-11.0}

11.1 General Requirements

11.1.1 Except as otherwise noted previously and in this Section, spa pools shall comply with all other requirements of these Regulations.

11.2 Location

11.2.1 A spa pool shall be at least eight (8) feet away from any other pool.

11.3 Decks and Walkways

11.3.1 A deck at least four (4) feet wide shall be provided around at least fifty (50) per cent of the perimeter of a spa pool.

11.3.2 If the spa pool is free standing and not higher than thirty six (36) inches, the deck may be at floor level.

11.4 Steps and Benches

11.4.1 Spa pools which are greater than twenty-four (24) inches deep shall have at least one (1) step with at least one (1) handrail and all steps shall be located at a point where the deck is at least four (4) feet wide.

11.4.2 The step tread shall be at least ten (10) inches deep and at least twelve (12) inches wide, and the step riser shall be at least seven (7) inches and not be more than twelve (12) inches high.

11.4.3 When the bottom tread also serves as the bench, the height above the pool floor shall not exceed fourteen (14) inches.

11.4.4 The first and last risers need not be uniform. Intermediate risers, however, shall be uniform in height.

11.4.5 Benches that are installed in spa pools shall be permanent and the depth of water over the bench shall not exceed twenty-four (24) inches.

11.4.5.1 The top surface edge of all benches and steps shall be outlined in contrasting color by a marking line at least one (1) inch wide.

11.5 Recirculation System

11.5.1 The spa pool recirculation system shall be completely separate from the air/water jet system and shall be capable of providing a minimum of ninety-six (96) turnovers of the pool volume per day [one (1) every fifteen (15) minutes] against the maximum head.

11.6 Perimeter Overflow Gutters and Surface Skimmers

11.6.1 All spa pools shall be equipped with either a perimeter overflow gutter or at least one skimmer which is connected to the recirculation system and effectively removes any floating material.

11.7 Inlets

11.7.1 All spa pools shall have at least two (2) inlets which are connected to the recirculation system and in spa pools where only one (1) skimmer is required, the inlets shall be located such that they direct water toward the skimmer

11.8 Air Jetting System

11.8.1 All air jetting (blower) systems shall have a raised loop or some other approved method to prevent water backup that could cause electrical shock hazards.

**History**
- *19 DE Reg. 309 (10/01/15)*

##### **16 Del. Admin. Code § 4464-12.0** Water Slide Flume {#sec-4464-12.0 omnilex-key=us-de-regs-official--title-16--4464-12.0}

12.1 General Requirements

12.1.1 Except as otherwise noted previously and in this Section, water slide flumes shall comply with all other requirements of these Regulations.

12.2 Splash Pool Design and Depth

12.2.1 In order to facilitate prompt, safe exiting by bathers, all splash pools shall have either a set of steps along the entire length of the exit side (side opposite the flume terminus), or a floor that slopes upward to meet the water surface.

12.2.2 The steps or upward sloping floor shall have one (1) handrail per flume or one (1) handrail every seven (7) feet, whichever is greater.

12.2.3 Ladders shall be prohibited.

12.2.4 The depth of the splash pool at the flume end shall be at least three (3) feet and not more than four (4) feet, and this depth shall be maintained for at least twenty (20) feet in front of the flume end.

12.2.5 The floor slope shall not exceed one (1) foot in seven (7) feet and all slopes shall be constant.

12.3 Flume End

12.3.1 Flumes shall terminate either at a depth of at least six (6) inches below the splash pool operating water level, or not more than two (2) inches above the splash pool operating water level, provided the flume is level for at least the last ten (10) feet.

12.3.2 The distance between the side of any flume end and the side of the splash pool shall be at least five (5) feet.

12.3.3 The distance between the sides of adjacent flumes shall be at least six (6) feet and adjacent flumes utilizing the same splash pool shall be parallel at the ends.

12.4 Decks and Walkways

12.4.1 A deck at least ten (10) feet in width shall be provided along the entire exit side of the splash pool.

12.4.2 All walks and steps from the exit side to the top of the flume shall be: at least four (4) feet wide;

12.4.3 constructed of concrete or other slip resistant material approved by the Division;

12.4.4 smooth, easily cleanable and properly maintained;

12.4.5 and separated from any flume by a physical barrier such that people on the walks or steps cannot reach the flumes.

12.5 Recirculation System

12.5.1 The water slide flume recirculation system shall be capable of providing a minimum of twenty-four (24) turnovers of the splash pool and pump reservoir volume per day [one (1) every hour] against the maximum head.

12.6 Pump Reservoirs

12.6.1 Pump reservoirs shall be separate from the splash pool, shall be made of concrete or other impervious material with a smooth slip-resistant finish, and shall be connected to the splash pool by a weir.

12.6.2 The minimum pump reservoir volume shall be equal to five (5) minutes of the combined flow rate in gpm of all water slide flume pumps. Pump reservoirs shall be accessible only to authorized individuals.

12.6.3 Access decks shall be provided.

12.6.4 The pump intake(s) shall be located in the pump reservoir and shall be designed to allow cleaning without danger of operator entrapment.

12.6.5 The pump reservoir shall have a minimum of one (1) main drain with separate piping and valve to the filtration system.

12.6.6 Pumps shall have check valves on all discharge lines.

12.7 Perimeter Overflow Gutters and Surface Skimmers

12.7.1 All splash pools and pump reservoirs shall have either perimeter overflow gutters or surface skimmers which effectively remove any floating material and are connected to the recirculation system.

12.7.2 Where perimeter overflow gutters are used, they are not required along the weirs or under the flume end.

12.7.3 Where surface skimmers are used, one (1) shall be in the splash pool and one (1) shall be in the pump reservoir.

12.7.4 Where an odd number of surface skimmers are required they shall be positioned appropriately based on the size of the splash pool and pump reservoir.

12.8 Disinfection

12.8.1 Water slide flume pools may be permitted to manually add a halogen disinfectant, in addition to the automatic feeder, if it can be done somewhere other than the flume or splash pool.

12.9 Special Purpose Pools

12.9.1 General Requirements

12.9.1.1 The Division shall require compliance with any Sections of these Regulations which are deemed necessary, to assure the health and safety of special purpose pool bathers.

12.9.1.2 The approval of special purpose pools shall be approved by plan review as per Section 3.4.

**History**
- *19 DE Reg. 309 (10/01/15)*

##### **16 Del. Admin. Code § 4464-13.0** Spray Pads {#sec-4464-13.0 omnilex-key=us-de-regs-official--title-16--4464-13.0}

13.1 General Requirements

13.1.1 Except as otherwise noted previously and in this Section, spray pads shall comply with all other requirements of these Regulations

13.2 Surface

13.2.1 Shall have a slip-resistant and easily cleanable surface.

13.2.2 Any manufactured surfacing shall be deemed suitable by the manufacturer for aquatic and chlorinated environments.

13.3 Slope – Spray Pads shall be properly sloped so that only water from the pad flows back to the collection tank.

13.3.1 Adjacent areas adjacent to the spray pad shall be sloped away from the collection drains.

13.3.2 The slope of the Spray Pad shall be sufficient to prevent standing water from collecting on the pad.

13.4 Drains

13.4.1 The size, number and locations of the spray pad drains shall be determined and specified so as to assure water does not accumulate on the pad.

**History**
- *19 DE Reg. 309 (10/01/15)*

##### **16 Del. Admin. Code § 4464-14.0** Administrative Action {#sec-4464-14.0 omnilex-key=us-de-regs-official--title-16--4464-14.0}

14.1 Operating Without a Permit

14.1.1 If a pool is found operating without a valid permit, the Division shall order immediate closure.

14.1.2 The closure shall be effective upon receipt of a written notice by the person in charge of the pool.

14.1.3 The pool shall remain closed until submission, review and approval of plans, followed by a sanitary survey confirming compliance with these Regulations and issuance of an operating permit.

14.1.4 A conspicuous, colored placard shall be prominently displayed at all entrances of the pool which has failed to obtain a valid permit.

14.2 Suspension of a Permit

14.2.1 If conditions exist at a pool which presents an imminent health hazard to the public, the Director may suspend the operating permit and order immediate closure without a hearing upon written notice.

14.2.2 The suspension shall be effective upon receipt of written notice by the person in charge and a suspension statement on the Environmental Health Report constitutes a written notice.

14.2.3 The person in charge shall yield the permit to the Division.

14.2.4 A suspension notice shall be issued for any of the following conditions:

14.2.4.1 The clarity of the water is not in compliance with the provisions of Section 8.3.

14.2.4.2 The bacteriological quality of the swimming pool water is not in compliance with the provisions of Section 8.6.

14.2.4.3 The pH of the swimming pool water is less than 7.2 or greater than 7.8.

14.2.4.4 The automatic disinfection system is not functioning properly, or, there is no automatic disinfection system or disinfectant present.

14.2.4.5 The free chlorine residual is less than the level specified in Section 8.6.

14.2.4.6 The bromine residual is less than the level specified in Section 8.6.

14.2.4.7 The cyanuric acid level is greater than one hundred (100) ppm.

14.2.4.8 The recirculation pump is not operating or not present.

14.2.4.9 The filter is not operating or not present.

14.2.4.10 There is no qualified lifeguard or attendant on duty (unless exempted by 16 Del.C.)

14.2.4.11 The water temperature exceeds 104oF in a spa pool.

14.2.4.12 There is a bare electrical wire or other obvious electrical hazard present.

14.2.4.13 The lighting is not in compliance with the provisions of Section 5.1.11. and because of this, the following are not clearly visible without glare from the deck:

14.2.4.13.1 the main drain(s) and all bottom markings;

14.2.4.13.2 or a black disk six (6) inches in diameter superimposed upon a white field and placed on the bottom at the deepest point.

14.2.4.13.3 The bottom drain cover/grate is missing, broken, or not properly secured.

14.2.4.14 An authorized representative of the Division is denied immediate access to the pool pursuant to Section 4.1.3.

14.2.4.15 Fecal material is discharged into the pool water.

14.2.4.16 The facility fails to provide a qualified operator pursuant to Section 4.4.

14.2.4.17 There is any other condition, or combination of conditions which may endanger the health, safety, or welfare of the bathers.

14.2.4.18 If the person in charge, the pool operator or the lifeguard/attendant determines that any of the above conditions exist, they shall immediately close the pool.

14.2.5 The Division shall be notified of the closure and the pool shall remain closed until the condition is satisfactorily corrected.

14.2.6 The person in charge of the pool may request in writing, to the Division at any time during the suspension, an Environmental Health Report for the purpose of showing that the imminent health hazard no longer exists.

14.2.7 The person in charge of the pool may also request, in writing, to the Division at any time during the suspension, an administrative hearing to challenge the findings of the Environmental Health Report that resulted in the pool closure.

14.2.8 When the Division determines that the imminent health hazard no longer exists, the suspension shall be terminated and the permit returned.

14.2.9 If the Division determines that the imminent health hazard has not been corrected and that the hazard still exists, the suspension remains in force pending a hearing and the Division may recommend that the permit be revoked.

**History**
- *19 DE Reg. 309 (10/01/15)*

##### **16 Del. Admin. Code § 4464-15.0** Hearings {#sec-4464-15.0 omnilex-key=us-de-regs-official--title-16--4464-15.0}

15.1 If the Division receives a request for a hearing, the Division shall schedule an administrative hearing within ten (10) days of the request. The purpose of the hearing is to determine if the suspension should be lifted.

15.1.1 Serious Violations, Repeat Violations and General Unsanitary Conditions

15.1.1.1 If serious violations, repeat violations, or general unsanitary conditions exist, the Division may issue and properly serve due notice, by certified mail or by hand delivery, of the intention of the Division to suspend or revoke the permit of a pool.

15.1.1.2 The Division shall, not suspend or revoke a permit of a pool for serious or repeated violations that do not present an imminent health hazard, without having first issued and properly served such notice of intent to suspend or revoke.

15.1.2 Within thirty (30) days of the date of such notice of intent to suspend or revoke, the permit holder may submit to the Division a written request for an administrative hearing.

15.1.3 The suspension or revocation shall commence upon expiration of the notice of intent, unless within thirty (30) days of the date of such notice, the Division receives from the permit holder a written request for an administrative hearing.

15.1.4 If the permit holder makes a timely request for an administrative hearing, the suspension or revocation shall be stayed pending the results of the hearing.

15.1.5 A conspicuous, colored placard shall be prominently displayed at all entrances of a pool whose permit stands suspended or revoked.

15.2 Pool Permit Holder Right to an Administrative Hearing

15.2.1 Upon due notice that the Division intends to suspend or revoke the permit of a pool as indicated in 15.2, or for other reasons to protect public health, the permit holder may submit to the Division, within thirty (30) days of the date of such notice of intent, a written request for an administrative hearing.

15.2.2 When an administrative hearing is scheduled, the permit holder of the pool shall be informed at least five (5) days prior to the hearing of the place, time and date of the hearing and the specific charges against the pool.

15.2.3 Notification of the hearing shall be by certified mail or by hand delivery. Failure of the permit holder to be present for an administrative hearing shall result in automatic suspension of the permit and recommendation for revocation.

15.3 Records of Administrative Hearings

15.3.1 A written report of the hearing decision shall be furnished by the Division to the permit holder of the pool.

**History**
- *19 DE Reg. 309 (10/01/15)*

##### **16 Del. Admin. Code § 4464-16.0** Enforcement and Interpretation {#sec-4464-16.0 omnilex-key=us-de-regs-official--title-16--4464-16.0}

16.1 No provisions of Sections of these Regulations shall be applied retroactively, or interpreted to require reconstruction, alteration or replacement of a pool, or any part of a pool, which has been approved by the Division and which has been installed or is under construction.

16.2 If, however, a pool or any part of a pool is reconstructed, altered or replaced, or if a private pool is converted to a public pool after the effective date of these Regulations, this conversion, reconstruction, alteration or replacement shall meet all of the provisions of these Regulations.

**History**
- *19 DE Reg. 309 (10/01/15)*

##### **16 Del. Admin. Code § 4464-17.0** Penalty {#sec-4464-17.0 omnilex-key=us-de-regs-official--title-16--4464-17.0}

Any person who neglects or fails to comply with the requirements of these Regulations shall be subject to the provisions of 16 Del.C. §107, and shall be fined not less than $100 and not more than $1000, together with the costs, unless otherwise provided by law.

**History**
- *19 DE Reg. 309 (10/01/15)*

##### **16 Del. Admin. Code § 4464-18.0** Repeal, Date of Effect and Amendments {#sec-4464-18.0 omnilex-key=us-de-regs-official--title-16--4464-18.0}

18.1 All Regulations or parts of Regulations in conflict with these Regulations are hereby repealed, and these Regulations shall be in full force and effect on the date of adoption by the Secretary, DHSS. The Secretary, DHSS may propose changes to the Regulations herein established and shall hold at least one public hearing on the proposed changes.

18.2 At least thirty (30) days in advance of the public hearing, notice of proposed changes shall be published in at least two newspapers of general circulation in the State. Notice shall include a brief synopsis of the changes to be made, information on when and where the proposed changes may be reviewed by the public, the procedure for submitting comments, and the time, date and location of the public hearing.

18.3 A hearing officer shall be appointed by the Secretary, DHSS, and a record shall be kept of the hearing.

Appendix A

All chemicals in pool water affect the tendency of the water to be corrosive or to deposit a calcium carbonate scale. It is possible to control these two (2) conditions through the use of the Langelier Index (L.I.). The index was developed in 1936 by Professor W.F. Langelier at the University of California (Berkeley). It expresses the relationship between pH, alkalinity, calcium hardness and temperature. The resulting number (formula method - below) or position on the nomograph (nomograph method - Appendix B) indicates whether the pool water is chemically “balanced”. In theory, pool water that is “balanced” will neither corrode nor deposit a scale.

LANGELIER INDEX/WATER BALANCE FORMULA METHOD

“Balanced” pool water has an L.I. between -0.3 and +0.3. An L.I. that is greater negatively than -0.3 indicates a corrosive water and an L.I. greater than +0.3 indicates a water that will deposit scale. After determining the pool water pH, alkalinity, calcium hardness and temperature, find the alkalinity factor (AF), calcium hardness factor (CHF) and temperature factor (TF) using the table below. Use the pH and these three (3) factors in the following equation:

L.I. = pH + AF + CHF + TF - 12.1

FACTORS NECESSARY TO CALCULATE THE L.I.

Sample Problem

A pool water has the following characteristics: pH-7.4; alkalinity-50; calcium hardness-50 ppm; temperature-78 F. Using the tables above, the factors are 1.7 for alkalinity, 1.3 for calcium hardness; and 0.6 for temperature. Using the formula:

L.I. = 7.4 + 1.7 + 1.3 + 0.6 - 12.1 = -1.1

This pool water is not balanced and is corrosive. The pH is within the required range and almost ideal, however, the alkalinity and calcium hardness should be much higher (see Appendix B). Alkalinity can be raised by adding sodium bicarbonate (baking soda) and lowered by adding muriatic acid or sodium bisulfate (dry acid). Calcium hardness can be raised by adding calcium chloride but can only be lowered by replacing part or all of the pool water with lower calcium hardness water.

Appendix B

Langelier Index/water Balance Nomograph Method

Measure the pool water pH, alkalinity and calcium hardness. The pH must be 7.2 - 7.8. pH can be raised by adding sodium carbonate (soda ash) and can be lowered by adding carbon dioxide (CO2), muriatic acid or sodium bisulfate (dry acid). Using the 104 F pH scale for spa pools and the 76 F pH scale for other pools, use a straight edge to line up the pH and alkalinity readings. The point where this extended line intersects the calcium hardness line is the level of calcium hardness needed for the water to be balanced. Do the same for pH and calcium hardness to get the alkalinity level needed for balance. The alkalinity and calcium hardness levels needed should be within the recommended ranges. Alkalinity can be raised by adding sodium bicarbonate (baking soda) and lowered by adding muriatic acid or sodium bisulfate (dry acid). Calcium hardness can be raised by adding calcium chloride but can only be lowered by replacing part or all of the pool water with lower calcium hardness water.

Appendix C

Division Training Requirements for the Qualified Operator

Qualifications: A qualified operator shall have completed an operator training course that is recognized by the Division.

Training Documentation: A qualified operator shall have a current certificate or written documentation acceptable to the Division showing completion of an approved operator training course.

Certificate Available: Originals or copies of such certificate or documentation shall be available on site for inspection by the Division for each qualified operator employed at or contracted by the site, as specified in this Regulation.

Essential Topics in Qualified Operator Training Courses

Course Content

All operator training courses recognized by the Division shall include, at a minimum, the following teaching elements:

1. Water disinfection,

2. Water chemistry,

3. Mechanical systems,

4. Health and safety, and

5. Operations.

1. Water Disinfection

1.1 Disinfectants types including

1.1.1 Descriptions of different types of disinfectants,

1.1.2 Their unique physical (e.g., shape or state [solid, liquid, or gas]) and chemical properties (e.g., how it reacts with acids or bases)

1.1.3 How they disinfect and impact water chemistry and monitoring systems,

1.1.4 How to calculate dosing,

1.1.5 How they are used safely, and

1.1.6 The advantages or disadvantages of using each disinfectant.

1.2 CT Values or Concentration x Time values including:

1.2.1 How to calculate the amount of time needed to inactivate pathogens at a given concentration of a disinfectant, and

1.2.2 The importance and reasons for maintaining appropriate water pH and temperature.

1.3 Bromine including:

1.3.1 Definition of bromine as an element,

1.3.2 Its use as a residual disinfectant and oxidizer in water,

1.3.3 Bromine chemistry,

1.3.4 The disinfection role of hypobromous acid,

1.3.5 On site generation,

1.3.6 pH meter requirements to prevent false readings, and

1.3.7 Bromine reuse.

1.4 Chlorine including:

1.4.1 Definition of chlorine as an element,

1.4.2 Its use as a residual disinfectant and oxidizer in water,

1.4.3 Chlorine chemistry and the role of PH,

1.4.4 The Disinfection role of hypochlorous acid,

1.4.5 Unstabilized products (sodium hypochlorite, calcium hypochlorite, lithium hypochlorite, and chlorine gas)

1.4.6 Stabilized products (sodium dichloro-s-triazinetrione and trichloro-s-triazinetrione),

1.4.7 Safe chemical handling, and

1.4.8 On-site Chlorine generation.

1.5 Cyanuric Acid (CYA) and stabilized chlorine product use including:

1.5.1 Description of CYA and how chlorine is bound to it;

1.5.2 Description of CYA use via addition of stabilized chlorine compounds or addition of cyanuric acid alone;

1.5.3 Response curves showing the impact of CYA on stabilization of chlorine residuals in the presence of UV;

1.5.4 Dose response curves showing the impact of CYA on chlorine kill rates including the impact of CYA concentrations on diarrheal fecal incident remediation procedures;

1.5.5 Strategies for controlling the concentration of CYA; and

1.5.6 Strategies for reducing the concentration of CYA when it exceeds the maximum allowable level.

1.6 Breakpoint/ Super-Chlorination including how to achieve it through calculation of chemical dosing to reach the desired free chlorine level and its relationship to reducing and controlling formation of combined chlorine including guidance for how to perform breakpoint chlorination in indoor aquatic settings.

1.7 Hyperchlorination including procedures for implementation of fecal/vomit/blood contamination response.

1.8 Combined Chlorine including:

1.8.1 How different combined chlorine and disinfection by-products are formed in the water and air;

1.8.2 The maximum acceptable level of combined chlorine;

1.8.3 How methods such as water replacement, breakpoint chlorination, ultraviolet light, ozone, ventilation, and use of other oxidizers can reduce combined chlorine level;

1.8.4 The advantages and disadvantages of each; and 5) Possible health effects of combined chlorine products in the air, particularly in indoor aquatic facilities.

1.9 Secondary Disinfection Systems including:

1.9.1 How ozone and ultraviolet disinfectants are used in conjunction with residual disinfectants to inactivate pathogens, and

1.9.2 Sizing guidelines/dosing calculations, safe use, and advantages and disadvantages of each method.

1.10 Supplemental Disinfection including other disinfection chemicals or systems on the market and their effectiveness in water treatment.

2. Water Chemistry Course work for water chemistry shall include:

2.1 Source Water including requirements for supply and pre-treatment.

2.2 Water Balance including:

2.2.1 Effect of unbalanced water on disinfection, pool feature surfaces, mechanical equipment, and fixtures; and

2.2.2 Details of water balance including pH, total alkalinity, calcium hardness, temperature, and TDS.

2.3 Saturation Index including calculations, ideal values, and effects of values which are too low or too high.

2.4 Water Clarity including:

2.4.1 Reasons why water quality is so important;

2.4.2 Causes of poor water clarity;

2.4.3 Maintenance of good water clarity; and

2.4.4 Closure requirements when water clarity is poor.

2.5 pH including:

2.5.1 How pH is a measure of the concentration of hydrogen ions in water;

2.5.2 Effects of high and low pH on bathers and equipment;

2.5.3 Ideal pH range for bather and equipment;

2.5.4 Factors that affect pH;

2.5.5 How pH affects disinfectant efficacy; and

2.5.6 How to decrease and increase pH.

2.6 Total Alkalinity including:

2.6.1 How total alkalinity relates to pH;

2.6.2 Effects of low and high total alkalinity;

2.6.3 Factors that affect total alkalinity;

2.6.4 Ideal total alkalinity range, and

2.6.5 How to increase or decrease total alkalinity.

2.7 Calcium Hardness including:

2.7.1 Why water naturally contains calcium;

2.7.2 How calcium hardness relates to total hardness and temperature;

2.7.3 Effects of low and high calcium hardness;

2.7.4 Factors that affect calcium hardness;

2.7.5 Ideal calcium hardness range; and

2.7.6 How to increase or decrease calcium hardness.

2.8 Temperature including:

2.8.1 How low and high water temperatures increase the likelihood of corrosion and scaling, respectively;

2.8.2 Effect on disinfection, its health effects, and other operational considerations;

2.8.3 Health effects; and

2.8.4 Other operational considerations.

2.9 Total Dissolved Solids (TDS) including:

2.9.1 Why the concentration of TDS increases over time;

2.9.2 Association with conductivity and organic contaminants; and

2.9.3 Key TDS levels as they relate to starting up a pool and galvanic corrosion.

2.10 Water Treatment Systems including:

2.10.1 Descriptions of system use, monitoring, calibration, and maintenance of automatic controllers;

2.10.2 Descriptions of common types of liquid, dry chemical, and gas mechanical feeders;

2.10.3 CHLORINE, bromine, and ozone generators;

2.10.4 Ultraviolet light systems;

2.10.5 Unique features of feeders, generators, and systems;

2.10.6 How to generally operate and maintain them;

2.10.7 Advantages and disadvantages of different feeders, ultraviolet light systems, and ozonator types; and

2.10.8 Alternate treatment methods.

2.11 Water Testing including:

2.11.1 How different methods (including but not limited to colorimetric, titrimetric, turbidimetric, and electronic) test water to determine the following levels:

2.11.1.1 Free available and total chlorine,

2.11.1.2 Total bromine,

2.11.1.3 pH,

2.11.1.4 Total alkalinity,

2.11.1.5 Calcium hardness,

2.11.1.6 Temperature,

2.11.1.7 TDS,

2.11.1.8 CYA,

2.11.1.9 Metals, and

2.11.1.10 Any other tests (including but not limited to salt concentrations, phosphates, nitrates, potassium monopersulfate, copper, iron, and bacterial testing);

2.11.2 The advantages and disadvantages of each method;

2.11.3 How to maintain testing equipment;

2.11.4 How to collect water samples;

2.11.5 How to perform and interpret tests;

2.11.6 How frequently to test;

2.11.7 The steps of the dilution method; and

2.11.8 How to calculate combined chlorine levels.

3. Mechanical Systems Course work for mechanical systems shall include:

3.1 Maintenance Calculations including:

3.1.1 Explanations of why particular calculations are important;

3.1.2 How to convert units of measurement within and between the English and metric systems;

3.1.3 How to determine the surface area of regularly and irregularly shape aquatic venues

3.1.4 How to determine the water volume of regularly and irregularly shaped aquatic venues; and

3.1.5 Why proper sizing of filters, pumps, pipes, and feeders is important

3.2 Circulation including:

3.2.1 Why circulation is needed;

3.2.2 Factors that affect water flow;

3.2.3 How direct suction and overflow systems work;

3.2.4 How to calculate turnover and flow rates;

3.2.5 How the following components of the circulation system relate to each other:

3.2.5.1 Main drains,

3.2.5.2 Gutters and surface skimmers,

3.2.5.3 Circulation pump and motor,

3.2.5.4 Surge tanks,

3.2.5.5 Vacuum ports,

3.2.5.6 Valves, and

3.2.5.7 Return inlets;

3.2.6 How to read flow meters;

3.2.7 How to safely operate pressurized systems after the pump;

3.2.8 Information on dye testing; 9) An understanding of total dynamic head (TDH);

3.2.9 How it TDH calculated;

3.2.10 How TDH is field-determined using vacuum and pressure gauges;

3.2.11 TDH effect on pump flow; and

3.2.12 Cross connections

3.3 Main Drains including:

3.3.1 A description of the role of main drains;

3.3.2 Why they should not be resized without engineering and public health consultation;

3.3.3 The importance of daily inspection of structural integrity; and

3.3.4 Discussion on balancing the need to maximize surface water flow while minimizing the likelihood of entrapment.

3.4 Gutters & Surface Skimmers including:

3.4.1 Why it is important to collect surface water;

3.4.2 A description of different gutter types (at a minimum: scum, surge, and rim-flow);

3.4.3 How each type generally works;

3.4.4 The advantages and disadvantages of each; and

3.4.5 Description of the components of SKIMMERS (e.g., weir, basket, and equalizer assembly) and their respective roles.

3.5 Mechanical System Balance including:

3.5.1 An understanding of mechanical system balancing;

3.5.2 Methodology for setting proper operational water levels;

3.5.3 Basic hydraulics which affect proper functioning of the balance tank and aquatic venues;

3.5.4 Methods of setting and adjusting modulation valves;

3.5.5 Balance lines;

3.5.6 Skimmers;

3.5.7 Main drains;

3.5.8 The operation of the water make-up system;

3.5.9 Collector tanks/gravity drainage systems; and

3.5.10 Automatic controllers.

3.6 Circulation Pump & Motor including:

3.6.1 Descriptions of the role of the pump and motor;

3.6.2 Self-priming and flooded suction pumps;

3.6.3 Key components of a pump and how they work together;

3.6.4 Cavitation;

3.6.5 Possible causes of cavitation; and

3.6.6 Troubleshooting problems with the pump and motor.

3.7 Valves including modulating/ automatic, and check) and their safe operation.

3.8 Return Inlets including a description of the role of return inlets and the importance of replacing fittings with those that meet original specifications.

3.9 Filtration including

3.9.1 Why filtration is needed;

3.9.2 A description of pressure and vacuum filters and different types of filter media;

3.9.3 How to calculate filter surface area;

3.9.4 How to read pressure gauges;

3.9.5 A general description of sand, cartridge, and diatomaceous earth filters and alternative filter media types to include, at a minimum, perlite, zeolite, and crushed glass;

3.9.6 The characteristic flow rates and particle size entrapment of each filter type;

3.9.7 How to generally operate and maintain each filter type;

3.9.8 Troubleshooting problems with the filter; and

3.9.9 The advantages and disadvantages of different filters and filter media.

3.10 Filter Backwashing/Cleaning including:

3.10.1 Determining and setting proper backwash flow rates;

3.10.2 When backwashing/cleaning should be done and the steps needed for clearing a filter of fine particles and other contaminants;

3.10.3 Proper disposal of waste water from backwash; and

3.10.4 What additional fixtures/equipment may be needed (i.e., sump, separation tank).

4. Health and Safety Course work for health and safety shall include:

4.1 Recreational Water Illness (RWI) including:

4.1.1 How water can contain or become contaminated with parasites, bacteria, viruses, fungi, disinfection by-products, or unsafe levels of chemicals; and

4.1.2 The role of the operator in reducing risk.

4.2 Causes of RWIs

4.2.1 Common infectious and chemical causes of RWIs, including but not limited to:

4.2.1.1 Diarrheal illness (Cryptosporidium, Giardia, Shigella, and norovirus);

4.2.1.2 Skin rashes (Pseudomonas aeruginosa, molluscum contagiosum);

4.2.1.3 Respiratory illness (Legionella);

4.2.1.4 Neurologic infections (echovirus, Naegleria);

4.2.1.5 Eye/ear illness (Pseudomonas aeruginosa, adenovirus, Acanthamoeba);

4.2.1.6 Hypersensitivity reactions (Mycobacterium avium complex, Pontiac fever, endotoxins); and

4.2.1.7 Health effects of chloramines and disinfection by-products.

4.3 RWI Prevention including:

4.3.1 Methods of prevention of RWIs, including but not limited to chemical level control;

4.3.2 Why public health, operators, and patrons need to be educated about RWIs and collaborate on RWI prevention;

4.3.3 The role of showering;

4.3.4 The efficacy of swim diapers;

4.3.5 Formed-stool and diarrheal fecal incident response; and

4.3.6 Developing a plan to minimize pathogens and other biological (e.g., blood, vomit, sweat, urine, and skin and hair care products) contamination of the water.

4.4 Risk Management including techniques that identify hazards and risks and that prevent illness and injuries associated with aquatic facilities open to the public.

4.5 Record Keeping including the need to keep accurate and timely records of the following areas:

4.5.1 Operational conditions (e.g., water chemistry, water temperature, filter pressure differential, flow meter reading, and water clarity);

4.5.2 Maintenance performed (e.g., backwashing, change of equipment);

4.5.3 Incidents and response (e.g., fecal incidents in the water and injuries); and

4.5.4 Staff training and attendance.

4.6 Chemical Safety including steps to safely store and handle chemicals including:

4.6.1 How to read labels and material safety data sheets;

4.6.2 How to prevent individual chemicals and inorganic and organic chlorine products from mixing together or with other substances (including water) or in chemical feeders; and

4.6.3 Use of PPE.

4.7 Entrapment Prevention including:

4.7.1 Different types of entrapment (e.g., hair, limb, body, evisceration/disembowelment, and mechanical);

4.7.2 How to prevent and/or decrease likelihood of entrapment; and

4.7.3 Requirements of the Virginia Graeme Baker Pool and Spa Safety Act.

4.8 Electrical Safety including possible causes of electrical shock and steps that can be taken to prevent electrical shock (e.g., bonding, grounding, ground fault interrupters, and prevention of accidental immersion of electrical devices).

4.9 Rescue Equipment including a description and rationale for the most commonly found rescue equipment including:

4.9.1 Rescue tubes,

4.9.2 Reaching poles,

4.9.3 Ring buoys and throwing lines,

4.9.4 Backboards,

4.9.5 First aid kits,

4.9.6 Emergency alert systems,

4.9.7 Emergency phones with current numbers posted, and

4.9.8 Resuscitation equipment.

4.10 Injury Prevention including basic steps known to decrease the likelihood of injury, at a minimum:

4.10.1 Banning glass containers at aquatic facilities,

4.10.2 Patron education, and

4.10.3 Daily visual inspection for hazards.

4.11 Drowning Prevention including causes and prevention of drowning.

4.12 Barriers including descriptions of how fences, gates, doors, and safety covers can be used to prevent access to water; and basics of design that effectively prevent access to water.

4.13 Signage & Depth Markers including the importance of maintaining signage and depth markers.

4.14 Facility Sanitation including:

4.14.1 Steps to clean and disinfect all surfaces that patrons would commonly come in contact with (e.g., deck, restrooms, and diaper-changing areas), and

4.14.2 Procedures for implementation of Section 9.28 Fecal-Vomit-Blood Contamination Response, in relation to responding to a body fluid spill on these surfaces.

4.15 Emergency Response Plan including:

4.15.1 Steps to respond to emergencies (at a minimum, severe weather events, drowning or injury, contamination of the water, chemical incidents); and

4.15.2 Communication and coordination with emergency responders and local health department notification as part of an Emergency Action Plan.

5. Operations Course work for operations shall include:

5.1 Regulations including the application of local, regional, state, and federal regulations and standards relating to the operation of aquatic facilities.

5.2 Immediate Closure - Course work shall also highlight reasons why an inspector or operator would immediately close an aquatic facilities.

5.3 Local & State Health Departments including stressing the importance of a good working relationship with the local and state health department.

5.4 Aquatic Facility Types including common aquatic venue types and settings and a discussion of features and play equipment that require specific operation and maintenance steps.

5.5 Daily/Routine Operations including listing and describing the daily inspection and maintenance requirements of an aquatic facility including, but not limited items listed:

5.5.1 Walkways/deck and exits are clear, clean, free of debris;

5.5.2 Drain covers, vacuum fitting covers, skimmer equalizer covers, and any other suction outlet covers are in place, secure, and unbroken;

5.5.3 Skimmer baskets, weirs, lids, flow adjusters, and suction outlets are free of any blockage;

5.5.4 Inlet and return covers and any other fittings are in place, secure, and unbroken;

5.5.5 Safety warning signs and other signage are in place and in good repair;

5.5.6 Entrapment prevention systems are operational;

5.5.7 Recirculation, disinfection systems, controller(s), and probes are operating as required;

5.5.8 Secondary and/or supplemental disinfection systems are operating as required;

5.5.9 Underwater lights and other lighting are intact with no exposed wires or water in lights;

5.5.10 Slime and biofilm has been removed from accessible surfaces of aquatic venue, slides, and other aquatic features;

5.5.11 Doors to nonpublic areas (chemical storage spaces, offices, etc.) are locked;

5.5.12 First aid supplies are stocked;

5.5.13 Emergency communication equipment and systems are operational;

5.5.14 Fecal/vomit/blood incident contamination response protocols, materials, and equipment are available;

5.5.15 Aquatic features and amenities are functioning in accordance with the manufacturer's recommendations;

5.5.16 Fencing/barriers, gates, and self-latching or other locks are tested and are intact and functioning properly, and barriers do not have nearby furniture to encourage climbing;

5.5.17 Drinking fountains are clean and in functional condition;

5.5.18 Electrical devices are in good working condition and meet the requirements specified by Code;

5.5.19 Alarms, if required, are tested and functioning properly;

5.5.20 Assessing glare conditions throughout operating hours to assess whether the bottom and objects in the pool are clearly visible;

5.5.21 Play structures and diving boards are in good condition;

5.5.22 Safety equipment is in good condition, properly secured, accessible for intended use, and shall include at a minimum:

5.5.22.1 Rescue tubes,

5.5.22.2 Resuscitation masks with one-way valve,

5.5.22.3 First aid kits,

5.5.22.4 AED’s,

5.5.22.5 Emergency oxygen,

5.5.22.6 Backboard, head immobilizer, straps, and

5.5.22.7 Lifeguard stands;

5.5.23 Emergency shut-off systems (slides, water features, pumps, etc.) function properly;

5.5.24 Depth markings are clearly visible;

5.5.25 Lifelines and buoys are in place and in good working order;

5.5.26 Ladders are non-slip and rungs secured tightly;

5.5.27 Waterslides are in functional, safe condition;

5.5.28 Moveable fulcrum is adjusted properly to control spring in the board as necessary;

5.5.29 Moveable starting blocks are properly stored;

5.5.30 Access to permanent starting blocks is restricted or controlled when not in use by swim teams and prohibited when not in use by competitive swimming or swimming practice that is under direct supervision of an instructor or coach;

5.5.31 Railings are secure;

5.5.32 SVRS is functioning according to manufacturer’s guidelines;

5.5.33 Skimmers baskets and covers are clean and in place;

5.5.34 Water quality and clarity is Regulation compliant;

5.5.35 Water level is at an appropriate level;

5.5.36 Pumps retain the appropriate pressure;

5.5.37 Play structures are secure (consider water velocity and reference manufacturers recommended levels); and

5.5.38 Verify required documentation and records are in place and signed by the appropriate personnel.

5.6 Preventive Maintenance including how to develop:

5.6.1 A preventive maintenance plan,

5.6.2 Routine maintenance procedures, and

5.6.3 Record keeping system needed to track maintenance performed.

5.7 Weatherizing including the importance of weatherizing and the steps to prevent damage to aquatic facilities and their mechanical systems due to very low temperatures or extreme weather conditions (e.g., flooding).

5.8 Facility Renovation & Design – Aquatic facility renovation and design including:

5.8.1 Definitions of aquatic facility renovation, remodeling, and substantial alternation;

5.8.2 When it is necessary to renovate;

5.8.3 When it is necessary to notify the Division of planned renovations and remodeling; and

5.8.4 Current trends in facility renovation and design.

5.9 Heating issues including:

5.9.1 Recommended water temperatures and limits,

5.9.2 Factors that contribute to the water’s heat loss and gain,

5.9.3 Heating equipment options,

5.9.4 Sizing gas heaters, and

5.9.5 How to troubleshoot problems with heaters.

5.10 Air Circulation including:

5.10.1 Air handling system considerations for an indoor aquatic facility,

5.10.2 The importance of regulating humidity,

5.10.3 The need to maintain negative pressure,

5.10.4 How poor indoor air quality can affect patrons and staff, and

5.10.5 How to balance air change and energy efficiency.

5.11 Spa & Therapy Pool Issues including:

5.11.1 Operational implications of smaller volumes of water and hot water,

5.11.2 How to maintain water chemistry,

5.11.3 Typical water temperature ranges highlighting maximum temperatures,

5.11.4 Risks of hyperthermia and hypothermia,

5.11.5 Need for emergency shut-off switches, and

5.11.6 Frequency of cleaning, draining, and disinfection.

**History**
- *19 DE Reg. 309 (10/01/15)*

#### **4465** Delaware Radiation Control Regulations

##### **16 Del. Admin. Code § 4465** Delaware Radiation Control Regulations {#sec-4465 omnilex-key=us-de-regs-official--title-16--4465}

Part A General Provisions

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-1.0** Purpose and Scope {#sec-4465-1.0 omnilex-key=us-de-regs-official--title-16--4465-1.0}

Except as otherwise specifically provided, this regulation applies to all persons who receive, possess, use, transfer, own, or acquire any source of ionizing radiation. However, nothing in this regulation except for registration of radiation machine facilities/sources as specified in Regulation 4465 Part B shall apply to any person to the extent such person is subject to regulation by the Nuclear Regulatory Commission. See 4465 Parts C & G of this regulation which pertain to radioactive materials licensing and federal oversight.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-2.0** Definitions {#sec-4465-2.0 omnilex-key=us-de-regs-official--title-16--4465-2.0}

As used in this regulation, these terms have the definitions set forth below. Additional definitions used only in a certain Part will be found in that Part.

"A1" means the maximum activity of special form radioactive material permitted in a Type A package. "A2" means the maximum activity of radioactive material, other than special form radioactive material, permitted in a Type A package. These values are either listed in Appendix A of Part T of these regulations, Table I, or may be derived in accordance with the procedure prescribed in Appendix A of Part T of these regulations.

"Absorbed dose" means the energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the gray (Gy) and the rad.

"Accelerator" means any machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and of discharging the resultant particulate or other radiation into a medium at energies usually in excess of 1 MeV. For purposes of this definition, "particle accelerator" is an equivalent term.

"Accelerator-produced material" means any material made radioactive by a particle accelerator.

"Activity" means the rate of disintegration or transformation or decay of radioactive material. The units of activity are the becquerel (Bq) and the curie (Ci).

“Address of use” means the building or buildings that are identified on the permit (license) and where radioactive materials may be produced, prepared, received, used, or stored.

"Adult" means an individual 18 or more years of age.

“Agency” means the Division of Public Health, Delaware Department of Health and Social Services.

"Agreement state" means any state with which the Nuclear Regulatory Commission or the Atomic Energy Commission has entered into an effective agreement under subsection 274b. of the Atomic Energy Act of 1954, as amended (73 Stat. 689).

"Airborne radioactive material" means any radioactive material dispersed in the air in the form of dusts, fumes, particulates, mists, vapors, or gases.

"Airborne radioactivity area" means a room, enclosure, or area in which airborne radioactive materials exist in concentrations:

(1) In excess of the derived air concentrations (DAC's) specified in Appendix B, Table I of Part D of this regulation; or

(2) To such a degree that an individual present in the area without respiratory protective equipment could exceed, during the hours an individual is present in a week, an intake of 0.6% of the annual limit on intake (ALI) or 12 DAC-hours.

"Airline respirator" (see "Supplied-air respirator (SAR)").

"Air-purifying respirator" means a respirator with an air-purifying filter, cartridge, or canister that removes specific air contaminants by passing ambient air through the air-purifying element.

"ARRT" means the American Registry of Radiologic Technologists.

“As low as is reasonably achievable" (ALARA) means making every reasonable effort to maintain exposures to radiation as far below the dose limits in these regulations as is practical, consistent with the purpose for which the licensed or registered activity is undertaken, taking into account the state of technology, the economics of improvements in relation to state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to utilization of nuclear energy and licensed or registered sources of radiation in the public interest.

"Assigned Protection Factor (APF)" means the expected workplace level of respiratory protection that would be provided by a properly functioning respirator or a class of respirators to properly trained and fitted users. Operationally, the inhaled concentration can be estimated by dividing the ambient airborne concentration by the APF.

"Atmosphere-supplying respirator" means a respirator that supplies the respirator user with breathing air from a source independent of the ambient atmosphere, and includes supplied-air respirators (SAR’s) and self-contained breathing apparatus (SCBA) units.

“Authorized user” means a practitioner of the healing arts who is identified as an authorized user on an agency, agreement state, licensing state or the Nuclear Regulatory Commission license that authorizes the medical use of radioactive material.

"Background radiation" means radiation from cosmic sources, naturally occurring radioactive material, (which has not been technologically enhanced) including radon, except as a decay product of source or special nuclear material, and including global fallout as it exists in the environment from the testing of nuclear explosive devices, or from past nuclear accidents such as Chernobyl that contribute to background radiation and are not under the control of the licensee or registrant. "Background radiation" does not include sources of radiation from radioactive materials regulated by the Agency.

"Becquerel" (Bq) means the Standard Internationale (SI) unit of activity. One becquerel is equal to 1 disintegration or transformation per second (dps or tps).

"Bioassay" means the determination of kinds, quantities or concentrations, and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body. For purposes of this regulation, "radiobioassay" is an equivalent term.

"Brachytherapy" means a method of radiation therapy in which radiation sources are utilized to deliver a radiation dose at a distance of up to a few centimeters, by surface, intracavitary, intraluminal, or interstitial application.

"Byproduct material" means:

(1) Any radioactive material (except special nuclear material) yielded in, or made radioactive by, exposure to the radiation incident to the process of producing or using special nuclear material;

(2) The tailings or wastes produced by the extraction or concentration of uranium or thorium from ore processed primarily for its source material content, including discrete surface wastes resulting from uranium solution extraction processes. Underground ore bodies depleted by these solution extraction operations do not constitute "byproduct material" within this definition;

(3) (i) Any discrete source of radium-226 that is produced, extracted, or converted after extraction, before, on, or after August 8, 2005, for use for a commercial, medical, or research activity; or

(ii) Any material that—

(A) Has been made radioactive by use of a particle accelerator; and

(B) Is produced, extracted, or converted after extraction, before, on, or after August 8, 2005, for use for a commercial, medical, or research activity; and

(4) Any discrete source of naturally occurring radioactive material, other than source material, that—

(i) The Commission, in consultation with the Administrator of the Environmental Protection Agency, the Secretary of Energy, the Secretary of Homeland Security, and the head of any other appropriate Federal agency, determines would pose a threat similar to the threat posed by a discrete source of radium-226 to the public health and safety or the common defense and security; and

(ii) Before, on, or after August 8, 2005, is extracted or converted after extraction for use in a commercial, medical, or research activity.

"Calendar quarter" means not less than 12 consecutive weeks nor more than 14 consecutive weeks. The first calendar quarter of each year shall begin in January and subsequent calendar quarters shall be so arranged such that no day is included in more than 1 calendar quarter and no day in any 1 year is omitted from inclusion within a calendar quarter. The method observed by the licensee or registrant for determining calendar quarters shall only be changed at the beginning of a year.

"Calibration" means the determination of (1) the response or reading of an instrument relative to a series of known radiation values over the range of the instrument, or (2) the strength of a source of radiation relative to a standard.

"CBRPA" means Certification Board for Radiology Practitioner Assistants.

"CFR" means Code of Federal Regulations.

“Chiropractic” means a drugless system of health care based on the principle that interference with the transmission of nerve impulses may cause disease, per Title 24 Delaware Code, Chapter 7, Board of Chiropractic, as amended.

"Collective dose" means the sum of the individual doses received in a given period of time by a specified population from exposure to a specified source of radiation.

"Committed dose equivalent" (HT.50) means the dose equivalent to organs or tissues of reference (T) that will be received from an intake of radioactive material by an individual during the 50-year period following the intake.

"Committed effective dose equivalent" (HE.50) is the sum of the products of the weighting factors (wT) applicable to each of the body organs or tissues that are irradiated and the committed dose equivalent to each of these organs or tissues (HE,50 = Σ wT HT,50).

“Controlled area” means an area, outside of a restricted but inside the site boundary, access to which can be limited by the licensee or registrant, for any reason.

“Critical group” means the group of individuals reasonably expected to receive the greatest exposure to residual radioactivity for any applicable set of circumstances.

"Curie" means the traditional unit of quantity of activity. One curie (Ci) is that quantity of radioactive material, which decays at the rate of 3.7E+10 disintegrations or transformations per second (dps or tps).

"Deep dose equivalent" (Hd), which applies to external whole body exposure, means the dose equivalent at a tissue depth of 1 centimeter (1000 mg/cm2).

"Demand respirator" means an atmosphere-supplying respirator that admits breathing air to the face piece only when a negative pressure is created inside the facepiece by inhalation

“Dentist” shall mean a person who is qualified to practice dentistry as prescribed in Title 24 Delaware Code, Chapter 11, Dentistry and Dental Hygiene, as amended.

"Department of Energy" means the Department of Energy established by Public Law 95-91, August 4, 1977, 91 Stat. 565, 42 U.S.C. Section 7101 as amended et seq., to the extent that the Department exercises functions formerly vested in the Atomic Energy Commission, its Chairman, members, officers and components and transferred to the Energy Research and Development Administration and to the Administrator thereof pursuant to sections 104(b), (c) and (d) of the Energy Reorganization Act of 1974 (Public Law 93-438, October 11, 1974, 88 Stat. 1233 at 1237, 42 U.S.C. 5814, effective January 19, 1975) and re-transferred to the Secretary of Energy pursuant to section 301(a) of the Department of Energy Organization Act (Public Law 95-91, August 4, 1977, 91 Stat. 565 at 577-578, 42 U.S.C. 7151, effective October 1, 1977 as amended.)

"Depleted uranium" means the source material uranium in which the isotope uranium-235 is less than 0.711 weight percent of the total uranium present. Depleted uranium does not include special nuclear material.

“Discrete source” means a radionuclide that has been processed so that its concentration within a material has been purposely increased for use for commercial, medical, or research activities.

"Disposable respirator" means a respirator for which maintenance is not intended and that is designed to be discarded after excessive breathing resistance, sorbent exhaustion, physical damage, or end-of-service-life renders it unsuitable for use. Examples of this type of respirator are a disposable half-mask respirator or a disposable escape-only self-contained breathing apparatus (SCBA).

"Distinguishable from background" means that the detectable concentration of a radionuclide is statistically different from the background concentration of that radionuclide in the vicinity of the site or, in the case of structures, in similar materials using adequate measurement technology, survey, and statistical techniques.

"Dose" is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed dose equivalent, committed effective dose equivalent, total organ dose equivalent, or total effective dose equivalent. For purposes of this regulation, "radiation dose" is an equivalent term.

"Dose equivalent (HT)" means the product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the sievert (Sv) and rem.

"Dose limits" means the permissible upper bounds of radiation doses established in accordance with this regulation. For purposes of this regulation, "limits" is an equivalent term.

"Effective dose equivalent (HE)" means the sum of the products of the dose equivalent to the organ or tissue (HT) and the weighting factor (wT) applicable to each of the body organs or tissues that are irradiated (HE = Σ wTHT).

"Embryo/fetus" means the developing human organism from conception until the time of birth.

"Exposure" generally means being exposed to ionizing radiation or to radioactive material;

"Exposure rate" means the exposure per unit of time, such as roentgen per minute or milliroentgen per hour.

"Exposure units" specifically as used in these regulations, the SI unit of exposure is coulomb per kilogram (C/kg), see Part A, Section 9.0 of this Part for Units of Exposure and Dose.

"External dose" means that portion of the dose equivalent received from any source of radiation outside the body.

"Extremity" means hand, elbow, and arm below the elbow, foot, knee, and leg below the knee.

“Facility” means the location, building vehicle, or complex under 1 administrative control, at which 1 or more radiation sources are installed, located and/or used.

"Filtering facepiece (dust mask)" means a negative pressure particulate respirator with a filter as an integral part of the facepiece or with the entire facepiece composed of the filtering medium, not equipped with elastomeric sealing surfaces and adjustable straps.

"Fit factor" means a quantitative estimate of the fit of a particular respirator to a specific individual, and typically estimates the ratio of the concentration of a substance in ambient air to its concentration inside the respirator when worn.

"Fit Test" means the use of a protocol to qualitatively evaluate the fit of a respirator on an individual.

"Former Atomic Energy Commission or Nuclear Regulatory Commission licensed facilities" means nuclear reactors, nuclear fuel reprocessing plants, uranium enrichment plants, or critical mass experimental facilities where Atomic Energy Commission or Nuclear Regulatory Commission licenses have been terminated.

"Generally applicable environmental radiation standards" means standards issued by the Environmental Protection Agency under the authority of the Atomic Energy Act of 1954, as amended, that impose limits on radiation exposures or levels, or concentrations or quantities of radioactive material, in the general environment outside the boundaries of locations under the control of persons possessing or using radioactive material.

"Gray" (Gy) means the Standard Internationale (SI) unit of absorbed dose. One gray is equal to an absorbed dose of 1 joule per kilogram (100 rad).

"Hazardous waste" means those wastes designated as hazardous by the Environmental Protection Agency regulations in 40 CFR Part 261, as amended.

“Healing arts” includes but is not limited to the practice of medicine, surgery, dentistry, registered pharmacy, podiatry, osteopathy, chiropractic, or veterinary medicine or nursing.

“Healing arts screening” means the testing of human beings using X-ray machines for the detection or evaluation of health indications when such tests are not specifically and individually ordered by a licensed practitioner of the healing arts legally authorized to prescribe such X-ray tests for the purpose of diagnosis or treatment.

"Helmet" means a rigid respiratory inlet covering that also provides head protection against impact and penetration.

"High radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of 1 mSv (0.1 rem) in 1 hour at 30 centimeters from any source of radiation or 30 centimeters from any surface that the radiation penetrates.

"Hood" means a respiratory inlet covering that completely covers the head and neck and may also cover portions of the shoulders and torso.

"Human use" means the internal or external administration of radiation or radioactive material to human beings.

"Individual" means any human being.

"Individual monitoring" means the assessment of:

(1) Dose equivalent (a) by the use of individual monitoring devices or (b) by the use of survey data; or

(2) Committed effective dose equivalent (a) by bioassay or (b) by determination of the time-weighted air concentrations to which an individual has been exposed, that is, DAC-hours. [See the definition of DAC-hours in 4465 Part D of this regulation.]

(3) Dose equivalent by the use of survey data.

"Individual monitoring devices" means devices designed to be worn by a single individual for the assessment of dose equivalent. For purposes of these regulations, "personnel dosimeter" and "dosimeter" are equivalent terms. Examples of individual monitoring devices are film badges, thermoluminescence dosimeters (TLDs), pocket ionization chambers, optically stimulated luminescence (OSL) dosimeters and personal (lapel) air sampling devices.

"Inspection" means an official examination or observation including, but not limited to, tests, surveys, and monitoring to determine compliance with rules, regulations, orders, requirements, and conditions of the Agency.

"Instrument traceability" (for ionizing radiation measurements) means the ability to show that an instrument has been calibrated at specified time intervals using a national standard or a transfer standard. If a transfer standard is used, the calibration must be at a laboratory accredited by a program, which requires continuing participation in measurement quality assurance with the National Institute of Standards and Technology, or other equivalent national or international program.

"Interlock" means a device arranged or connected such that the occurrence of an event or condition is required before a second event or condition can occur or continue to occur.

"Internal dose" means that portion of the dose equivalent received from radioactive material taken into the body.

"JRCECT" means Joint Review Committee on Education in Cardiovascular Technology.

"JRCERT" means Joint Review Committee on Education in Radiologic Technology.

“JRCNMT” means Joint Review Committee on Nuclear Medicine Technology.

"Lens dose equivalent (LDE)" means the external exposure to the lens of the eye as the dose equivalent at a tissue depth of 0.3 centimeter (300 mg/cm2).

"License" means a license issued by the US Nuclear Regulatory Commission, Agreement State, or the Agency, in accordance with applicable federal or state regulations, as amended.

"Licensed practitioner" means an individual licensed to practice medicine, dentistry, podiatry, chiropractic, osteopathy, or veterinary medicine in this state. For the purpose of this regulation, advanced practice registered nurses (APRNs) and physicians assistants (PAs) may order diagnostic or supportive X-ray procedures for patients in accordance with Title 24, Delaware Code. APRNs and PAs who supervise, perform, view, or interpret X-ray procedures do so within their scope of practice, as governed by Title 24, Delaware Code.

"Licensed [or registered] material" means radioactive material received, possessed, used, transferred or disposed of under a general or specific license [or registration] issued by the Agency.

"Licensee" means the holder of a license.

"Limits" [See "Dose limits"].

"Loose-fitting facepiece" means a respiratory inlet covering that is designed to form a partial seal with the face.

"Lost or missing source of radiation" means licensed [or registered] source of radiation whose location is unknown. This definition includes, but is not limited to, radioactive material that has been shipped but has not reached its planned destination and whose location cannot be readily traced in the transportation system.

"Major processor" means a user processing, handling, or manufacturing radioactive material exceeding Type A quantities as unsealed sources or material, or exceeding 4 times Type B quantities as sealed sources, but does not include nuclear medicine programs, universities, industrial radiographers, or small industrial programs. Type A and B quantities are defined in T.2 of these regulations.

"Member of the public" means any individual except when that individual is receiving an occupational dose.

"Minor" means an individual less than 18 years of age.

“Misadministration” means an event that meets the criteria in 4465 Part X, Therapeutic Radiation Machines, subsection 5.2 of this regulation.

"Monitoring" means the measurement of radiation, radioactive material concentrations, surface area activities or quantities of radioactive material and the use of the results of these measurements to evaluate potential exposures and doses. For purposes of this regulation, "radiation monitoring" and "radiation protection monitoring" are equivalent terms.

"Natural radioactivity" means radioactivity of naturally occurring nuclides.

"Negative pressure respirator (tight fitting)" means a respirator in which the air pressure inside the facepiece is negative during inhalation with respect to the ambient air pressure outside the respirator.

"NORM" means any naturally occurring radioactive material. It does not include byproduct, source, or special nuclear material.

"NRC" means the US Nuclear Regulatory Commission or its duly authorized representatives.

“Notice of Violation” means a written statement of 1 or more alleged infringements of a legally binding requirement. The notice normally requires the licensee, registrant or other permit holder to provide a written statement describing the following:

(1) Corrective steps taken by the licensee, registrant or other permit holder and the results achieved;

(2) Corrective steps to be taken to prevent recurrence; and

(3) The projected date for achieving full compliance. The Authority may require responses to notices of violation to be under oath.

"Occupational dose" means the dose received by an individual in the course of employment in which the individual's assigned duties for the licensee or registrant involve exposure to sources of radiation, whether or not the sources of radiation are in the possession of the licensee, registrant, or other person. Occupational dose does not include doses received from background radiation, or from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with U.S. Nuclear Regulatory Commission Regulations, from voluntary participation in medical research programs, or as a member of the public.

“Office of Engineering” means the office in the Delaware Division of Public Health that reviews radiation shielding plans and/or design plans and issues an Approval to Construct letter for new radiation source facilities or rooms.

“Office of Radiation Control” means the office in the Delaware Division of Public Health which carries out the Delaware Radiation Control Regulations, issues radiation source facility registration permits, and performs on-site inspections of new and existing radiation machine facilities to determine compliance.

“Owner/leasee” means the person/individual who owns/leases the radiation source. An out-of-state owner shall authorize a manager to sign the application form.

"Package" means the packaging together with its radioactive contents as presented for transport.

"Particle accelerator" [See "Accelerator"].

"Person" means any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, agency, political subdivision of this state, any other state or political subdivision or agency thereof, and any legal successor, representative, agent, or agency of the foregoing, [but shall not include federal government agencies].

"Personnel monitoring equipment" [See "Individual monitoring devices"].

"Physician" means an allopathic doctor of medicine and surgery or a doctor of osteopathic medicine and surgery who is registered and certified to practice medicine pursuant to Title 24 Delaware Code, Chapter 17, Medical Practice Act, as amended.

“Podiatrist” means a person who is qualified to practice podiatry and is licensed under Title 24 Delaware Code, Chapter 5, Podiatry, as amended.

"Positive pressure respirator" means a respirator in which the pressure inside the respiratory inlet covering exceeds the ambient air pressure outside the respirator.

"Powered air-purifying respirator (PAPR)" means an air-purifying respirator that uses a blower to force the ambient air through air-purifying elements to the inlet covering.

"Pressure demand respirator" means a positive pressure atmosphere-supplying respirator that admits breathing air to the facepiece when the positive pressure is reduced inside the facepiece by inhalation.

“Principal supervisor” means the licensed practitioner responsible for initiating use of X-ray equipment or other device generating ionizing radiation in the healing arts.

"Protective apron" means an apron made of radiation-attenuating materials used to reduce exposure to radiation.

"Public dose" means the dose received by a member of the public from exposure to sources of radiation released by the licensee or registrant, or to any other source of radiation under the control of the licensee or registrant. Public dose does not include occupational dose, or doses received from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with U.S. Nuclear Regulatory Commission Regulations, or from voluntary participation in medical research programs.

“Qualified expert” means an individual who has satisfactorily fulfilled the training and experience requirements consistent with achieving a level of competency sufficient to function effectively in the position for which registration is sought. Such individuals must demonstrate to the satisfaction of the Agency their qualifications, for example, individuals certified in the appropriate field by the American Board of Radiology, or the American Board of Health Physics, or the American Board of Medical Physics, or those having equivalent qualifications. With reference to the calibration of radiation therapy equipment, an individual, in addition to the above qualifications, must be qualified in accordance with 4465 Part F and 4465 Part X of this regulation, as amended.

"Qualified medical physicist (QMP)" means an individual who meets each of the following credentials:

1. Has earned a master's and/or doctoral degree in physics, medical physics, biophysics, radiological physics, medical health physics, or equivalent disciplines from an accredited college or university; and

2. Has been granted certification in the specific subfield(s) of medical physics with its associated medical health physics aspects by an appropriate national certifying body and abides by the certifying body's requirements for continuing education; and/or

3. Is credentialed in accordance with Regulation 4465, Part X, Therapeutic Radiation machines, subsection 3.4, as amended.

"Qualitative fit test (QLFT)" means a pass/fail fit test to assess the adequacy of respirator fit that relies on the individual’s response to the test agent.

"Quality factor" (Q) means the modifying factor, listed in Tables I and II of Part A, Section 13.0, that is used to derive dose equivalent from absorbed dose.

"Quantitative fit test (QNFT)" means an assessment of the adequacy of respirator fit by numerically measuring the amount of leakage into the respirator.

"Rad" means the traditional unit of absorbed dose. One rad is equal to an absorbed dose of 100 erg per gram or 0.01 joule per kilogram (0.01 gray).

"Radiation" means alpha particles, beta particles, gamma rays, X-rays, neutrons, high-speed electrons, high-speed protons, and other particles capable of producing ions. For purposes of this regulation, ionizing radiation is an equivalent term. Radiation, as used in this regulation, does not include non-ionizing radiation, such as radiowaves or microwaves, visible, infrared, or ultraviolet light.

"Radiation area" means any area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 0.05 mSv (0.005 rem) in 1 hour at 30 centimeters from the source of radiation or from any surface that the radiation penetrates.

"Radiation dose" [See "Dose"].

"Radiation machine" means any device capable of producing ionizing radiation except those devices with radioactive material as the only source of radiation.

“Radiation safety officer” or RSO for a radiation machine facility means an individual assigned to perform RSO duties who has training and experience in the safe and effective use of radiation machines, their potential radiation hazards, and emergency precautions applicable to the type of activity or facility to which the RSO is assigned.

"Radiation technician" means any individual who has not graduated from an approved program in radiation technology, but has passed an Authority approved examination.

"Radiation technologist" means any individual who has successfully completed a JRCERT or JRCNMT approved program in radiation technology and has passed a national certification examination in his or her field of specialization.

"Radiation technology" means the use of a radioactive substance or equipment emitting ionizing radiation on humans for diagnostic or therapeutic purposes.

"Radioactive material" means any solid, liquid or gas which emits radiation spontaneously.

"Radioactivity" means the transformation of unstable atomic nuclei by the emission of radiation.

"Radiobioassay" [See "Bioassay"].

"Radiologist" means a physician specializing in radiology certified by or board-eligible for the American Board of Radiology, the American Osteopathic Board of Radiology, the Royal College of Radiologists, or the Royal College of Physicians and Surgeons of Canada.

"Radiologist assistant" or "RA" means a radiation technologist who has successfully completed an ARRT recognized program for radiologist assistants and has passed the ARRT registered radiologist assistant examination or the CBRPA radiology practitioner assistant examination.

"Registrant" means any person who is registered with the Agency and is legally obligated to register with the Agency pursuant to this regulation and the Act.

"Registration" means registration with the Agency in accordance with the regulations adopted by the Agency.

"Regulations of the Department of Transportation" means the regulations in 49 CFR Parts 100-189, as amended.

"Rem" means the traditional unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem is equal to the absorbed dose in rad multiplied by the quality factor. (1 rem = 0.01 Sv)

"Research and development" means (1) theoretical analysis, exploration, or experimentation; or (2) the extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials, and processes. Research and development does not include the internal or external administration of radiation or radioactive material to human beings in the healing arts.

"Residual radioactivity" means radioactivity in structures, materials, soils, groundwater, and other media at a site resulting from activities under the licensee’s control. This includes radioactivity from all licensed and unlicensed sources used by the licensee, but excludes background radiation. It also includes radioactive materials remaining at the site as a result of routine or accidental releases of radioactive materials at the site and previous burials at the site, even if those burials were made in accordance with the provisions of Part D of this regulation.

"Restricted area" means an area, access to which is limited by the licensee or registrant for the purpose of protecting individuals against undue risks from exposure to sources of radiation. Restricted area does not include areas used as residential quarters, but separate rooms in a residential building may be set apart as a restricted area.

"Roentgen" means the traditional unit of exposure. One roentgen (R) equals 2.58E-4 coulombs per kilogram of air (see "Exposure" and Part A, subsection 9.1).

"Sealed source" means any encapsulated radioactive material, which has been constructed in such a manner as to prevent the escape of any radioactive material.

"Sealed Source and Device Registry (SSD)" means the national registry that contains the registration certificates, maintained by the Nuclear Regulatory Commission (NRC), that summarize the radiation safety information for sealed sources and devices, and describe the licensing and use conditions approved for the product.

"Self-contained breathing apparatus (SCBA)" means an atmosphere-supplying respirator for which the breathing air source is designed to be carried by the user.

"Shallow dose equivalent" (Hs), which applies to the external exposure of the skin or an extremity, means the dose equivalent at a tissue depth of 0.007 centimeter (7 mg/cm2) averaged over the contiguous 10 square centimeters of skin receiving the highest exposure.

"SI" means the abbreviation for Standard Internationale, the International Metric System of Measurement.

"Sievert" means the Standard Internationale (SI) unit of any of the quantities expressed as dose equivalent. The dose equivalent in sievert is equal to the absorbed dose in gray multiplied by the quality factor. (1 Sv = 100 rem)

"Source material" means:

(1) Uranium or thorium, or any combination thereof, in any physical or chemical form; or

(2) Ores that contain by weight 1/20 of 1.0% (0.05%) or more of uranium, thorium or any combination of uranium and thorium. Source material does not include special nuclear material.

"Source material milling" means any activity that results in the production of byproduct material as defined by definition (2) of byproduct material, of this part.

"Source of radiation" means any radioactive material or any device or equipment emitting, or capable of producing, radiation.

"Source traceability" means the ability to show that a radioactive source has been calibrated either by the national standards laboratory of the National Institute of Standards and Technology, or by a laboratory which participates in a continuing measurement quality assurance program with National Institute of Standards and Technology or other equivalent national or international program.

"Special form radioactive material" means radioactive material that satisfies the following conditions:

(1) It is either a single solid piece or is contained in a sealed capsule that can be opened only by destroying the capsule;

(2) The piece or capsule has at least 1 dimension not less than 5 millimeters (0.2 inch); and

(3) It satisfies the test requirements specified by the Nuclear Regulatory Commission. A special form encapsulation designed in accordance with the Nuclear Regulatory Commission requirements in effect on June 30, 1983, and constructed prior to July 1, 1985, may continue to be used. A special form encapsulation either designed or constructed after June 30, 1985, must meet requirements of this definition applicable at the time of its design or construction.

"Special nuclear material" means:

(1) Plutonium, uranium-233, uranium enriched in the isotope 233 or in the isotope 235, and any other material that the Nuclear Regulatory Commission, pursuant to the provisions of section 51 of the Atomic Energy Act of 1954, as amended, determines to be special nuclear material, but does not include source material; or

(2) Any material artificially enriched by any of the foregoing but does not include source material.

"Special nuclear material in quantities not sufficient to form a critical mass" means uranium enriched in the isotope U-235 in quantities not exceeding 350 grams of contained U-235; uranium-233 in quantities not exceeding 200 grams; plutonium in quantities not exceeding 200 grams; or any combination of them in accordance with the following formula: For each kind of special nuclear material, determine the ratio between the quantity of that special nuclear material and the quantity specified above for the same kind of special nuclear material. The sum of such ratios for all of the kinds of special nuclear material in combination shall not exceed 1. For example, the following quantities in combination would not exceed the limitation and are within the formula:

“Standard Internationale (SI)” means the international metric systems of measurement.

“State Radiation Control Act” or “the Act” means Title 16 Delaware Code, Chapter 74, Radiation Control, as amended.

"Supplied-air respirator (SAR)" means an atmosphere-supplying respirator for which the source of breathing air is not designed to be carried by the user.

"Survey" means an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal, or presence of sources of radiation. When appropriate, such evaluation includes, but is not limited to, tests, physical examinations, and measurements of levels of radiation or concentrations of radioactive material present.

"Test" means the process of verifying compliance with an applicable regulation.

"These regulations" means all parts of The Delaware Radiation Control Regulations 4465, as amended.

"Tight-fitting facepiece" means a respiratory inlet covering that forms a complete seal with the face.

"Total effective dose equivalent" (TEDE) means the sum of the deep dose equivalent for external exposures and the committed effective dose equivalent for internal exposures.

"Total organ dose equivalent" (TODE) means the sum of the deep dose equivalent and the committed dose equivalent to the organ receiving the highest dose as described in Part D, subsection 39.1.6 of this regulation.

"Traceable to a National Standard" [See "Instrument traceability" or "Source traceability"].

"Unrefined and unprocessed ore" means ore in its natural form prior to any processing such as grinding, roasting, beneficiating, or refining.

"Unrestricted area" means an area, access to which is neither limited nor controlled by the licensee or registrant. For purposes of this regulation, "uncontrolled area" is an equivalent term.

"User seal check (fit check)" means an action conducted by the respirator user to determine if the respirator is properly seated to the face. Examples include negative pressure check, positive pressure check, irritant smoke check, or isoamyl acetate check.

"Very high radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving an absorbed dose in excess of 5 Gy (500 rad) in 1 hour at 1 meter from a source of radiation or 1 meter from any surface that the radiation penetrates.

“Veterinarian” shall mean a person who has received a degree in veterinary medicine from a school of veterinary medicine, per Title 24 Delaware Code, Chapter 33, Veterinarians, as amended.

"Waste" means those low-level radioactive wastes that are acceptable for disposal in a land disposal facility. For the purposes of this definition, low-level waste has the same meaning as in the Low-Level Radioactive Waste Policy Act, P.L. 96-573, as amended by P.L. 99-240, effective January 15, 1986; that is, radioactive waste (a) not classified as high-level radioactive waste, spent nuclear fuel, or byproduct material as defined in Section 11e.(2) of the Atomic Energy Act, as amended (uranium or thorium tailings and waste) and (b) classified as low-level radioactive waste consistent with existing law and in accordance with (a) by the Nuclear Regulatory Commission.

"Waste handling licensees" mean persons licensed to receive and store radioactive wastes prior to disposal and/or persons licensed to dispose of radioactive waste.

"Week" means 7 consecutive days starting on Sunday.

"Whole body" means, for purposes of external exposure, head, trunk including male gonads, arms above the elbow, or legs above the knee.

"Worker" means an individual engaged in activities under a license or registration issued by the Agency and controlled by a licensee or registrant, but does not include the licensee or registrant.

"Working level" (WL) means any combination of short-lived radon daughters in 1 liter of air that will result in the ultimate emission of 1.3E+5 MeV of potential alpha particle energy. The short-lived radon daughters of radon-222 are polonium-218, lead-214, bismuth-214, and polonium-214; and those of radon-220 are polonium-216, lead-212, bismuth-212, and polonium-212.

"Working level month" (WLM) means an exposure to 1 working level for 170 hours. 2,000 working hours per year divided by 12 months per year is approximately equal to 170 hours per month.

"Year" means the period of time beginning in January used to determine compliance with the provisions of these regulations. The licensee or registrant may change the starting date of the year used to determine compliance by the licensee or registrant provided that the change is made at the beginning of the year. If a licensee or registrant changes in a year, the licensee or registrant shall assure that no day is omitted or duplicated in consecutive years.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-3.0** Exemptions from the Regulatory Requirements {#sec-4465-3.0 omnilex-key=us-de-regs-official--title-16--4465-3.0}

3.1 Exemptions. An exemption may be granted by the Agency if, based on documented and publicly available information, the Agency has verified that the proposed exempted practice or equipment does not pose any danger to the applicant, his employees or any others coming into contact with the exempted practice or equipment. An exemption request that deviates from accepted standards as specified in the regulations, such that the safe use of said practice or equipment cannot be supported by extraneous documented and publicly available information must be referred to the Authority on Radiation Protection for consideration.

3.1.1 General Provision. The Agency as the Agent for the Authority on Radiation Protection may, upon application or upon its own initiative, grant such exemptions or exceptions from the requirements of the regulations as it determines are authorized by law and will not result in undue hazard to public health and safety or property.

3.1.2 Department of Energy Contractors and Nuclear Regulatory Commission Contractors. Any Department of Energy contractor or subcontractor and any Nuclear Regulatory Commission contractor or subcontractor of the following categories operating within this State is exempt from the regulations to the extent that such contractor or subcontractor under his contract receives, possesses, uses, transfers, or acquires sources of radiation:

3.1.2.1 Prime contractors performing work for the Department of Energy at U.S. Government-owned or -controlled sites, including the transportation of sources of radiation to or from such sites and the performance of contract services during temporary interruptions of such transportation;

3.1.2.2 Prime contractors of the Department of Energy performing research in, or development, manufacture, storage, testing, or transportation of, atomic weapons or components thereof;

3.1.2.3 Prime contractors of the Department of Energy using or operating nuclear reactors or other nuclear devices in a United States Government-owned vehicle or vessel; and

3.1.2.4 Any other prime contractor or subcontractor of the Department of Energy or of the Nuclear Regulatory Commission when the State and the Nuclear Regulatory Commission jointly determine:

3.1.2.4.1 That the exemption of the prime contractor or subcontractor is authorized by law; and

3.1.2.4.2 That, under the terms of the contract or subcontract, there is adequate assurance that the work thereunder can be accomplished without undue risk to the public health and safety.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-4.0** General Regulatory Requirements {#sec-4465-4.0 omnilex-key=us-de-regs-official--title-16--4465-4.0}

4.1 Records. Each licensee and registrant shall maintain records showing the receipt, transfer, and disposal of all sources of radiation. Additional record requirements are specified elsewhere in the regulations.

4.2 Inspections

4.2.1 Each licensee and registrant shall afford the Agency at all reasonable times opportunity to inspect sources of radiation and the premises and facilities wherein such sources of radiation are used or stored.

4.2.2 Each licensee and registrant shall make available to the Agency for inspection, upon reasonable notice, records maintained pursuant to the regulations.

4.3 Tests. Each licensee and registrant shall perform upon instructions from the Agency, or shall permit the Agency to perform, such reasonable tests as the Agency deems appropriate or necessary including, but not limited to, tests of:

4.3.1 Sources of radiation;

4.3.2 Facilities wherein sources of radiation are used or stored;

4.3.3 Radiation detection and monitoring instruments; and

4.3.4 Other equipment and devices used in connection with utilization or storage of licensed or registered sources of radiation.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-5.0** Additional Regulatory Requirements {#sec-4465-5.0 omnilex-key=us-de-regs-official--title-16--4465-5.0}

The Authority through the Agency may, by rule, regulation, or order, impose upon any licensee or registrant such requirements in addition to those established in the regulations as it deems appropriate or necessary to minimize danger to public health and safety or property.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-6.0** Enforcement Requirements {#sec-4465-6.0 omnilex-key=us-de-regs-official--title-16--4465-6.0}

6.1 Violations. An injunction or other court order may be obtained prohibiting any violation of any provision of the State Radiation Control Act, as amended or any regulation or order issued thereunder. The Authority may request the Attorney General to make application to the Court of Chancery for an order enjoining any acts or practices which constitute or will constitute a violation of any provision of this chapter or any rule, regulation or order issued thereunder.

6.2 Impounding. Sources of radiation shall be subject to impoundment pursuant to Title 16 Delaware Code, Section 7415 of the State Radiation Control Act, as amended.

6.3 Prohibited Uses

6.3.1 A hand-held fluoroscopic screen shall not be used with X-ray equipment unless it has been listed in the Registry of Sealed Source and Devices or accepted for certification by the Food and Drug Administration, Center for Devices and Radiological Health.

6.3.2 A shoe-fitting fluoroscopic device shall not be used.

6.3.3 A closed end PID (conical position indicating device) shall not be used.

6.3.4 A source of radiation shall not be abandoned.

6.4 Penalties. In addition to any other remedies available to the Authority – the Authority may assess an administrative penalty in an amount not to exceed $500 for a first offense, an amount not to exceed $750 for a subsequent offense. Each violation of this chapter or rules, regulations or orders shall be considered a separate offense.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-7.0** Interpretations {#sec-4465-7.0 omnilex-key=us-de-regs-official--title-16--4465-7.0}

Except as specifically authorized by the Agency in writing, no interpretation of the regulations by an officer or employee of the Agency other than a written interpretation by the Authority on Radiation Protection will be recognized to be binding upon the Agency.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-8.0** Communications {#sec-4465-8.0 omnilex-key=us-de-regs-official--title-16--4465-8.0}

All communications and reports concerning the regulations, and applications filed thereunder, should be addressed to the Agency at its Office of Radiation Control, Division of Public Health, 417 Federal Street, Dover, DE 19901.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-9.0** Units of Exposure and Dose {#sec-4465-9.0 omnilex-key=us-de-regs-official--title-16--4465-9.0}

9.1 As used in these regulations, the unit of exposure is the coulomb per kilogram (C/kg) of air. One roentgen is equal to 2.58E-4 coulomb per kilogram of air.

9.2 As used in these regulations, the units of dose are:

9.2.1 Gray (Gy) is the SI unit of absorbed dose. One gray is equal to an absorbed dose of 1 joule per kilogram (100 rad).

9.2.2 Rad is the traditional unit of absorbed dose. One rad is equal to an absorbed dose of 100 erg per gram or 0.01 joule per kilogram. (0.01 Gy)

9.2.3 Rem is the traditional unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem is equal to the absorbed dose in rad multiplied by the quality factor. (1 rem = 0.01 Sv)

9.2.4 Sievert is the SI unit of any of the quantities expressed as dose equivalent. The dose equivalent in sievert is equal to the absorbed dose in gray multiplied by the quality factor. (1 Sv = 100 rem)

9.3 As used in this regulation, the quality factors for converting absorbed dose to dose equivalent are shown in Table I:

9.4 If it is more convenient to measure the neutron fluence rate than to determine the neutron dose equivalent rate in sievert per hour or rem per hour, as provided in Part A, subsection 9.3, 0.01 Sv (1 rem) of neutron radiation of unknown energies may, for purposes of these regulations, be assumed to result from a total fluence of 25 million neutrons per square centimeter incident upon the body. If sufficient information exists to estimate the approximate energy distribution of the neutrons, the licensee or registrant may use the fluence rate per unit dose equivalent or the appropriate Q value from Table II to convert a measured tissue dose in gray or rad to dose equivalent in sievert or rem.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-10.0** Units of Activity {#sec-4465-10.0 omnilex-key=us-de-regs-official--title-16--4465-10.0}

10.1 For purposes of this regulation, activity is expressed in the SI unit of becquerel (Bq) or in the special unit of curie (Ci), or their multiples, or disintegrations or transformations per unit of time.

10.2 One becquerel (Bq) = 1 disintegration or transformation per second (dps or tps).

10.3 One curie (Ci) = 3.7E+10 disintegrations or transformations per second (dps or tps) = 3.7E+10 becquerel (Bq) = 2.22E+12 disintegrations or transformations per minute (dpm or tpm).

Part B Registration of Radiation Source Facilities and Services

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-1.0** Purpose and Scope {#sec-4465-1.0 omnilex-key=us-de-regs-official--title-16--4465-1.0}

This Part provides for:

1.1 The registration of ionizing radiation source facilities, and

1.2 The registration of persons providing ionizing radiation source installation, servicing, and/or other services listed in this Part.

1.3 In addition to the requirements of this Part, all registrants are subject to the applicable provisions of the General Provisions (4465, Part A), Standards for Protection (4465, Part D), and Notices, Instructions and Reports (4465, Part J) and Compliance Procedures (4465, Part K). In addition, some registrants are subject to provisions of the regulations for Industrial Radiography (4465, Part E), Diagnostic X-Rays and Imaging Systems in the Healing Arts (4465, Part F), Analytical Equipment (4465, Part H) or Particle Accelerators (4465, Part I) and Therapeutic Radiation Machines (4465, Part X).

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-2.0** Definitions {#sec-4465-2.0 omnilex-key=us-de-regs-official--title-16--4465-2.0}

“Agency” means the Division of Public Health, Delaware Department of Health and Social Services.

“Certificate of Approval to Construct” means a document stipulating that work will be done in accordance to the plans and specifications as approved by the Office of Engineering. If at any point after the issuance of a certificate of Approval To Construct there are any changes made to the plans, the Office of Engineering must be immediately notified for them to take appropriate action.

“Certificate of Approval to Operate” means a document indicating that requirements for operation of a new radiation machine facility have been approved by the Office of Radiation Control, following a pre-operational, on-site inspection.

“CFR” means Code of Federal Regulations.

“Chiropractic” means a drugless system of health care based on the principle that interference with the transmission of nerve impulses may cause disease, per 24 Del.C. Ch. 7, Board of Chiropractic, as amended.

“Dentist” shall mean a person who is qualified to practice dentistry as prescribed in 24 Del.C. Ch. 11, Dentistry and Dental Hygiene, as amended.

“Facility” means the location, building, vehicle, or complex under 1 administrative control, at which 1 or more radiation sources are installed, located and/or used.

“Healing arts” includes but is not limited to the practice of medicine, surgery, dentistry, registered pharmacy, podiatry, osteopathy, chiropractic, veterinary medicine or nursing.

“kVP” or Peak Tube Potential, means the maximum value of the potential difference across the X-ray tube during an exposure. This value is usually included in manufacturer’s technical specification for an X-ray device.

"Licensed practitioner" means an individual licensed to practice medicine, dentistry, podiatry, chiropractic, osteopathy, or veterinary medicine in this state. For the purpose of this regulation, advanced practice registered nurses (APRNs) and physicians assistants (PAs) may order diagnostic or supportive X-ray procedures for patients, in accordance with Title 24, Delaware Code. APRNs and PAs who supervise, perform, view, or interpret X-ray procedures do so within their scope of practice, as governed by Title 24, Delaware Code.

“Manager” means the individual working at the facility who is authorized by the owner to sign the application form as the applicant.

“Office of Engineering” means the office in the Delaware Division of Public Health which reviews radiation shielding plans, and issues approval for construction of new radiation machine facilities or rooms.

“Office of Radiation Control” means the office in the Delaware Division of Public Health which carries out the Delaware Radiation Control Regulations, issues radiation source facility registration permits, and performs on-site inspections of new and existing radiation machine facilities to determine compliance.

“Owner/leasee” means the person/individual who owns/leases the radiation source. An out-of-state owner shall authorize a manager working at the facility to sign the application form.

"Physician" means an allopathic doctor of medicine and surgery or a doctor of osteopathic medicine and surgery who is registered and certified to practice medicine pursuant to 24 Del.C. Ch. 17, Medical Practice Act, as amended.

“Podiatrist” means a person who is qualified to practice podiatry and is licensed under 24 Del.C. Ch. 5, Podiatry, as amended.

“Principal supervisor” means the licensed practitioner responsible for initiating use of X-ray equipment or other device generating ionizing radiation in the healing arts.

“Qualified expert” means an individual who has satisfactorily fulfilled the training and experience requirements consistent with achieving a level of competency sufficient to function effectively in the position for which registration is sought. Such individuals must demonstrate to the satisfaction of the Agency their qualifications, for example, individuals certified in the appropriate field by the American Board of Radiology, or the American Board of Health Physics, or the American Board of Medical Physics, or those having equivalent qualifications. With reference to the calibration of radiation therapy equipment, an individual, in addition to the above qualifications, must be qualified in accordance with 4465 Part F and 4465 Part X of these regulations, as amended.

"Qualified medical physicist (QMP)" means an individual who meets each of the following credentials:

1. Has earned a master's and/or doctoral degree in physics, medical physics, biophysics, radiological physics, medical health physics, or equivalent disciplines from an accredited college or university; and

2. Has been granted certification in the specific subfield(s) of medical physics with its associated medical health physics aspects by an appropriate national certifying body and abides by the certifying body's requirements for continuing education; and/or

3. Is credentialed in accordance with Regulation 4465, Part X, Therapeutic Radiation machines, subsection 3.4, as amended.

“Radiation source” see source of radiation.

“Radiation safety officer” or RSO for a radiation machine facility means an individual assigned to perform radiation safety duties who has training and experience in the safe and effective use of radiation machines, their potential radiation hazards, and emergency precautions applicable to the type of activity or facility to which the RSO is assigned.

“Radiation service provider” means company or person who provides radiation services to registered radiation source facilities in Delaware, see Section 9.0 of this Part.

“Source of radiation” means any radioactive material or any device or equipment emitting, or capable of producing, ionizing radiation.

“Storage” means a condition in which a device or source is not being used for an extended period of time, and has been made inoperable and shall be tagged as out of service.

“Veterinarian” shall mean a person who has received a degree in veterinary medicine from a school of veterinary medicine, per 24 Del.C. Ch. 33, Veterinarians, as amended.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-3.0** Prohibitions {#sec-4465-3.0 omnilex-key=us-de-regs-official--title-16--4465-3.0}

All registration permit-holders shall prohibit any person or company from furnishing radiation machine servicing or services to their radiation machine facility until such person provides evidence of registration with the Agency as a provider of services in accordance with Section, 9.0 of this Part.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-4.0** Exemptions {#sec-4465-4.0 omnilex-key=us-de-regs-official--title-16--4465-4.0}

4.1 Electronic equipment that produces radiation incidental to its operation for other purposes is exempt from the registration and notification requirements of this regulation, provided that the equivalent dose averaged over an area of 10 square centimeters does not exceed 5 µSv (0.5 millirem) per hour at 5 centimeters from any accessible surface of such equipment. The production, testing, or factory servicing of such equipment shall not be exempt.

4.2 Radiation machines in transit or in storage incident to transit are exempt from the requirements of this Part. This exemption does not apply to the providers of radiation machines for mobile services.

4.3 Domestic television receivers, computer monitors, and electron microscopes are exempt from the registration and notification requirements of this regulation.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-5.0** Shielding Plan Review {#sec-4465-5.0 omnilex-key=us-de-regs-official--title-16--4465-5.0}

5.1 Radiation machine facilities proposed for construction, renovation, or equipment installation after the effective date of this regulation that are designed to house X-ray machines with the potential to generate radiation dose to members of the public equal to or greater than 100 millirem per year, or expose a member of the public to an exposure rate equal to or greater than 2 milliroentgen per hour shall be required to submit a radiation shielding plan prepared by a qualified expert who is registered with the Office of Radiation Control as a radiation service provider (see Section 9.0 of this part). Radiation machine facilities or rooms which require a shielding plan include the following modalities:

5.2 New radiation machine facilities or rooms designed to house only X-ray machines that operate at maximum energy less than or equal to 70 kVP shall be exempt from the radiation shielding plan requirement; such devices include but are not limited to the following modalities:

5.2.1 Radiation machine facilities or rooms which generally do not require a shielding plan include the following modalities:

5.3 Prior to construction, the floor plans, shielding specifications and equipment arrangement of all new installations, or modifications of existing installations utilizing ionizing radiation sources with maximum energy greater than 70 kVP shall be submitted to the Division of Public Health Office of Engineering for review and approval. The required information is listed in Appendices A and B of this Part and Regulation 4465 Part X, Appendix A, for radiation therapeutic sources.

5.4 The Agency shall require the applicant to utilize the services of a qualified expert who is registered with the Agency [see Section 9.0 of this Part] to determine the shielding requirements prior to the plan review and approval. The registered consultant shall provide the shielding information on Form R15A or equivalent to the Office of Engineering, Division of Public Health, which will review the shielding plan and if determined acceptable, will issue a Certificate of Approval to Construct letter to the applicant.

5.5 The issuance of a Certificate of Approval to Construct by the Office of Engineering for radiation shielding plans shall not preclude the requirement of additional modifications should a subsequent analysis of operating conditions indicate the possibility of an individual receiving a dose in excess of the limits prescribed in Regulations 4465 Part D, Sections 6.0, 11.0, 12.0, and 13.0 of these regulations.

5.6 The Office of Radiation Control, Division of Public Health shall conduct a pre-operational, on-site inspection to evaluate shielding and/or operating conditions prior to issuance of the radiation machine registration permit and Certificate of Approval to Operate.

5.7 The Certificate of Approval to Operate issued by the Office of Radiation Control reflects regulatory compliance at the time of the pre-operational inspection of a new facility, and does not imply or certify the facility beyond the scope of that specific inspection.

5.8 After installation of any radiation machine, the registrant shall maintain for inspection by the Agency:

5.8.1 The maximum rated technique factors of each machine;

5.8.2 A scale drawing of the room in which a stationary radiation machine system is located with such drawing indicating the use of areas adjacent to the room and an estimation of the extent of occupancy by an individual in such areas. In addition, the drawing shall include:

5.8.2.1 The results of a survey for radiation levels present at the operator's position and at pertinent points outside the room at specified test conditions; or

5.8.2.2 The type and thickness of materials, or lead equivalency, of each protective barrier.

5.9 Radiation machine facilities that initiated design, construction or installation of dental panoramic, cephalometric, or cone beam CT devices prior to the effective date of this regulation shall maintain records of radiation surveys of exposure rate (milliroentgen per hour) levels present in uncontrolled public areas (ie. corridors or alcoves) where members of the public or employees may be present in the facility. If such surveys indicate an exposure rate equal to or greater than 2 millroentgen per hour is possible in uncontrolled public areas while X-ray equipment is in operation the facility shall provide administrative controls to limit the dose to members of the public with a visible barrier to delineate the controlled area.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-6.0** Registration of Radiation Source Facility {#sec-4465-6.0 omnilex-key=us-de-regs-official--title-16--4465-6.0}

6.1 Each owner of a radioactive material facility shall:

6.1.1 Apply for registration of such facility with the Agency prior to the receipt, possession, use, sale, transfer, ownership or acquisition of the radioactive material. Application for registration shall be completed on forms furnished by the Agency.

6.1.2 Designate on the application form an individual to be responsible for radiation protection, duties; (radiation safety officer), address of the facility, and for the radioactive material; element name, atomic mass, chemical or physical form and maximum amount to be possessed at any one time.

6.2 Each owner of a radiation machine facility shall:

6.2.1 Apply for registration of such facility with the Agency prior to the operation of a radiation source facility. Application for registration shall be completed on forms furnished by the Agency and shall contain all the information required by the form and accompanying instructions;

6.2.2 Designate on the application form an individual to be responsible for radiation protection duties; (radiation safety officer); per Appendix C of this Part.

6.2.3 A licensed practitioner responsible for directing the operation of radiation machines shall be designated on each healing arts X-ray facility application, specifying their Delaware license number and phone number. The signature of the administrator, president, or chief executive officer will be accepted in lieu of a licensed practitioner's signature if the facility has more than 1 licensed practitioner (for example, hospitals, large clinics, or multi-practitioner practices), except where prohibited by state law.

6.2.4 Prohibit any person from furnishing radiation source servicing or services as described in subsection 9.4 of this Part to their radiation source facility, until such person provides evidence that they have been registered with the Agency as a radiation service provider in accordance with Section 9.0 of this Part.

6.2.5 In any facility regulated by or requiring registration under these regulations, the registration permit-holder shall allow only individuals who are adequately trained in radiation safety and the safe and effective use of the machine to operate any radiation machine. The facility registration permit-holder shall document evaluation of the qualifications of each individual permitted to operate any radiation machine at the facility. Each operator shall meet all radiation safety training and experience requirements of the respective State of Delaware professional licensure board, as applicable, and any applicable requirements of these regulations (4465 Part B), and 4466 Radiation Technologist/Technician Certification Regulations.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-7.0** Registration of Mobile Service Operations {#sec-4465-7.0 omnilex-key=us-de-regs-official--title-16--4465-7.0}

7.1 In addition to the requirements of Section 6.0 of this Part, the applicant shall submit the following information:

7.1.1 An established main location where the machine(s), records, etc. will be maintained for inspection. This shall be a street address, not a post office box number.

7.1.2 A sketch or description of the normal configuration of each radiation machine's use, including the operator's position and any ancillary personnel's location during exposures. If a mobile van is used with a fixed unit inside, furnish the floor plan indicating protective shielding and the operator's location; and

7.1.3 A current copy of the applicant's operating and safety procedures including radiological practices for protection of patients, operators, employees, and the general public.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-8.0** Registration of Healing Arts Screening and Medical Research {#sec-4465-8.0 omnilex-key=us-de-regs-official--title-16--4465-8.0}

8.1 In addition to the requirements of 6.0 of this Part each applicant shall apply for and receive authorization for healing arts screening before initiating a screening program. The information and evaluation in Appendix E of this part shall be submitted with the application.

8.2 In addition to the requirements of 6.0 of this Part, any research using radiation machines on humans shall be approved by an Institutional Review Board (IRB) as required by Title 45, CFR, Part 46 and Title 21, CFR, Part 56, as amended.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-9.0** Application for Registration of Radiation Service Providers {#sec-4465-9.0 omnilex-key=us-de-regs-official--title-16--4465-9.0}

9.1 Each person or company who is engaged in the business of installing or offering to install radiation machines or is engaged in the business of furnishing or offering to furnish radiation machine servicing or services in this State shall apply for registration of such services with the Agency, and receive Agency approval prior to furnishing or offering to furnish any such services.

9.2 Application for registration shall be completed on forms furnished by the Agency and shall contain all information required by the Agency as indicated on the forms and accompanying instructions.

9.3 Each Radiation Service Provider applying for registration under this regulation shall specify:

9.3.1 That they have read and understand the requirements of this and other applicable regulations;

9.3.2 The education and training that qualify them to discharge the services for which they are applying for registration.

9.4 For the purpose of section 9.0, services may include but shall not be limited to:

9.4.1 Installation and/or servicing of radiation sources and associated radiation source components;

9.4.2 Calibration of radiation source or radiation measurement instruments or devices;

9.4.3 Radiation protection or health physics consultations or surveys;

9.4.4 Personnel dosimetry services;

9.4.5 Radiation Shielding Plans for X-Ray Rooms; or

9.4.6 Practice as a Qualified Medical Physicist.

9.5 No individual working as a Radiation Service Provider shall perform services which are not specifically authorized for that individual by the Agency.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-10.0** Issuance of Notice of Registration {#sec-4465-10.0 omnilex-key=us-de-regs-official--title-16--4465-10.0}

10.1 Upon a determination that an applicant meets the requirements of the regulations, the Agency shall issue a notice of registration, which shall be displayed by the registrant in public view.

10.2 The Agency may incorporate in the notice of registration at the time of issuance or thereafter by appropriate rule, regulation, or order, such additional requirements and conditions with respect to the registrant's receipt, possession, use, sale and/or transfer of ownership responsibility of radiation sources as it deems appropriate or necessary.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-11.0** Expiration of Notice of Registration {#sec-4465-11.0 omnilex-key=us-de-regs-official--title-16--4465-11.0}

Except as provided in Section 12.0 below, each notice of registration shall expire at the end of the specified day in the month and year stated therein.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-12.0** Renewal of Notice of Registration {#sec-4465-12.0 omnilex-key=us-de-regs-official--title-16--4465-12.0}

12.1 Application for renewal of registration shall be filed in accordance with Sections 6.0, 7.0 and/or 9.0 of this Part.

12.2 In any case in which a registrant not less than 30 days prior to the expiration of his existing notice of registration has filed an application in proper form for renewal, such existing notice of registration shall not expire until the application status has been finally determined by the Agency.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-13.0** Report of Changes {#sec-4465-13.0 omnilex-key=us-de-regs-official--title-16--4465-13.0}

The registrant shall notify the Agency in writing on forms furnished by the Agency before making any change which would render the information contained in the application for registration and/or the notice of registration no longer accurate. The Agency shall incorporate such changes and issue a corrected registration if necessary.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-14.0** Approval Not Implied {#sec-4465-14.0 omnilex-key=us-de-regs-official--title-16--4465-14.0}

No person, in any advertisement, shall refer to the fact that he or his facility is registered with the Agency pursuant to the provisions of Sections 6.0 or 9.0, and no person shall state or imply that any activity under such registration has been approved by the Agency.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-15.0** Assembler and/or Transfer Obligation {#sec-4465-15.0 omnilex-key=us-de-regs-official--title-16--4465-15.0}

15.1 Any person who sells, leases, transfers, lends, disposes, assembles, or installs radiation sources in this State shall notify the Agency within 15 days of:

15.1.1 The name and address of persons who have received these sources;

15.1.2 The manufacturer, model, and serial number of each radiation source transferred; and

15.1.3 The date of transfer of each radiation source.

15.1.4 In the case of diagnostic X-ray systems which contain certified components, a copy of the assembler's report prepared in compliance with requirements of the Federal diagnostic X-ray standard (21 CFR 1020.30(d)) shall be submitted to the Agency following completion of the assembly. Such report shall suffice in lieu of any other report by the assembler.

15.2 No person shall make, sell, lease, transfer, lend, assemble, or install radiation sources or the supplies used in connection with such machines unless such supplies and equipment when properly placed in operation and used shall meet the requirements of these regulations.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-16.0** Reciprocal Recognition of Out-of-State Radiation Sources {#sec-4465-16.0 omnilex-key=us-de-regs-official--title-16--4465-16.0}

16.1 Whenever any radiation source is to be brought into the State, for any temporary use, the person proposing to bring such source into the State shall submit a complete, prescribed application form to the Agency and must receive Agency approval at least 2 working days before such machine is to be brought into the State. The applicant must receive Agency approval prior to use. The notice shall include:

16.1.1 The number(s) and type(s) of radiation source(s);

16.1.2 The nature, start date, duration, and scope of use;

16.1.3 The exact location(s) where the radiation source is to be used; and

16.1.4 The name(s) of the Delaware licensed practitioner(s) and their professional license number(s) if the sources are used to irradiate human beings;

16.1.5 A copy of the person's home state registration license or equivalent document; and

16.1.6 The name(s) and address(es) where the source user(s) can be reached while in the state.

16.2 The person proposing to bring such out-of-state source into Delaware referred to in subsection 16.1 shall:

16.2.1 Comply with all applicable regulations of the Agency;

16.2.2 Supply the Agency with such other information as the Agency may reasonably request; and

16.2.3 Not operate within the state on a temporary basis in excess of 90 days. Permission to operate for more than 90 days may be granted by the Agency up to 180 days per year.

In order for the Agency to provide an evaluation, technical advice, and official approval on shielding requirements for a radiation installation, the following information must be submitted to the Office of Engineering in the Division of Public Health. The Agency may require a pre-operational inspection be conducted by the Office of Radiation Control to assure that design and operational safety requirements are met prior to approval of the radiation machine registration permit.

1. The plans showing, as a minimum, the following:

(a) The normal location of the system's radiation port; the port's travel and traverse limits; general direction(s) of the useful beam; locations of any windows and doors or other openings; the location of the operator's booth; and the location of the control panel;

(b) The structural composition and thickness or lead equivalence of all walls, doors, partitions, floor, and ceiling of the room(s) concerned;

(c) The dimensions of the room(s) concerned;

(d) The type of occupancy of all adjacent areas inclusive of space above and below the room(s) concerned. If there is an exterior wall, show distance to the closest area(s) where it is likely that individuals may be present;

(e) The make and model of the equipment, the maximum technique factors, and the energy waveform (single phase, three phase, etc.);

(f) The type of examination(s) or treatment(s) which will be performed with the equipment.

2. Information on the anticipated workload of the system(s) in mA-minutes per week.

3. A report showing all basic assumptions used in the development of the shielding specifications.

1. Space Requirements:

(a) The operator shall be allotted not less than 0.70 m2 (7.5 square feet) of unobstructed floor space in the booth;

(b) The operator's booth may be any geometric configuration with no dimension of less than 0.6 m (2 feet);

(c) The space shall be allotted excluding any encumbrance by the X‑ray control panel, such as overhang, cables, or other similar encroachments;

(d) The booth shall be located or constructed such that unattenuated direct scatter radiation originating on the examination table or at the wall-mounted image receptor will not reach the operator's position in the booth.

2. Structural Requirements:

(a) The booth walls shall be permanently fixed barriers of at least 2 m (7 feet) high;

(b) When a door or movable panel is used as an integral part of the booth structure, it must have an interlock which will prevent an exposure when the door or panel is not closed;

(c) Shielding shall be provided to meet the requirements of Part D of these regulations.

3. Radiation Exposure Control Placement:

The radiation exposure control for the system shall be fixed within the booth and:

(a) Shall be at least 1.0 m (40 inches) from any point subject to direct scatter, leakage or primary beam radiation;

(b) Shall allow the operator to use the majority of the available viewing windows.

4. Viewing System Requirements:

(a) Each booth shall have at least 1 viewing device which will:

(1) Be so placed that the operator can view the patient during any exposure; and

(2) Be so placed that the operator can have full view of any occupant of the room and should be so placed that the operator can view any entry into the room. If any door which allows access to the room cannot be seen from the booth, then outside that door there shall be an "X-ray on" warning sign that will be lighted anytime the rotor of the X-ray tube is activated. Alternatively, an interlock shall be present such that exposures are prevented unless the door is closed.

(b) When the viewing system is a window, the following requirements also apply:

(1) The window shall have a viewing area of at least 0.09 m2 (1 square foot);

(2) Regardless of size or shape, at least 0.09 m2 (1 square foot) of the window area must be centered no less than 0.6 m (2 feet) from the open edge of the booth and no less than 1.5 m (5.0 feet) from the floor;

(3) The window shall have at least the same lead equivalence as that required in the booth's wall in which it is mounted.

(c) When the viewing system is by mirrors, the mirror(s) shall be so located as to accomplish the general requirements of Appendix B4.(a).

(d) When the viewing system is by electronic means:

(1) The camera shall be so located as to accomplish the general requirements of Appendix B4.(a); and

(2) There shall be an alternate viewing system as a backup for the primary system.

The applicant or registration permit-holder, shall require each individual assigned to fulfill responsibilities and duties as Radiation Safety Officer (RSO) to be an individual who has training and experience in the safe and effective use of radiation machines and the potential radiation hazards and emergency precautions applicable to the type(s) of activity or facility for which the individual is seeking to perform RSO duties, to include:

I. Establishing and overseeing operating and safety procedures that maintain radiation exposures as low as reasonably achievable (ALARA), and to review them periodically to ensure that the procedures are current and conform with these regulations;

II. Ensuring that individual monitoring devices are properly used by occupationally exposed personnel as required by the regulations, that records are kept of the monitoring results, and that timely notifications are made as required by 4465 Part D;

III. Investigating and reporting to the agency each known or suspected case of radiation exposure to an individual or radiation level detected in excess of limits established by these regulations and each theft or loss of source(s) of radiation, determining the cause, and taking steps to prevent its recurrence;

IV. Having a thorough knowledge of management policies, administrative procedures and records of the registration permit-holder and keeping management informed on a periodic basis of the performance of the registrant’s radiation protection program, if applicable;

V. Assuming control and having the authority to institute corrective actions including shutdown of operations when necessary in emergency situations or unsafe conditions;

VI. Maintaining records as required by these regulations; and

VII. Ensuring that personnel are adequately trained and complying with these regulations, the conditions of the certificate of registration, and the operating and safety procedures of the registered permit-holder.

All persons performing radiation machine assembly, installation or repair shall meet the general requirements in subparagraph 1. of this paragraph and 1 or more of the specialized requirements in subparagraph 2. of this paragraph.

1. General requirements include:

(a) Experience or education providing familiarity with the type(s) of equipment to be serviced, to include radiation safety;

(b) Knowledge of protective measures to reduce potentially hazardous conditions; and

(c) Six months of supervised assembly and repair of the type(s) of equipment to be serviced.

2. Specialized requirements include:

(a) One year of formal training (may be satisfied by factory school, military technical training school, or other courses in radiation machine assembly, installation or repair techniques) or an associate's degree in biomedical equipment repair;

(b) A bachelor's degree in electrical engineering with specialized training in radiation producing devices; or

(c) A combination of training and experience equal to clause (a) of this subparagraph.

The following information must be submitted by persons proposing to conduct healing arts screening. Persons requesting that the agency approve a healing arts screening program shall submit the following information and evaluation.

1. Administrative controls to include the following:

(a) The name and address of the applicant and, where applicable, the names and addresses of agents within the state;

(b) The diseases or conditions for which the X‑ray examinations are to be used in diagnoses;

(c) A detailed description of the X‑ray examinations proposed in the screening program;

(d) A description of the population to be examined in the screening program, for example, age, sex, physical condition, and other appropriate information;

(e) An evaluation of any known alternate methods not involving ionizing radiation that could achieve the goals of the screening program and why these methods are not used instead of the X‑ray examination; and

(f) For mobile screening operations, location(s) where radiation machines are used and maintained.

2. Operating procedures for all X-ray systems (except bone densitometers) to include the following:

(a) An evaluation of the X-ray systems to be used in the screening program. The evaluation shall be performed by a licensed medical physicist with a specialty in diagnostic radiological physics. The evaluation shall show that such systems do satisfy all requirements of this section;

(b) A description of the diagnostic imaging quality control program; and

(c) A copy of the technique chart for the X‑ray examination procedures to be used.

3. Operating procedures for bone densitometers to include the manufacturer's evaluation of the system to be used in the screening program. The evaluation shall show that such systems satisfy all requirements of this section.

4. Training data to include the following:

(a) The qualifications of each individual who will be operating the X‑ray systems;

(b) The qualifications of the individual who will be supervising the operators of the X‑ray systems. The extent of supervision and the method of work performance evaluation shall be specified; and

(c) The name and address of the practitioner licensed in the state who will interpret the radiographs.

5. Records to include the following:

(a) A description of the procedures to be used in advising the individuals screened, and their private practitioners of the healing arts, of the results of the screening procedure and any further medical needs indicated; and

(b) A description of the procedures for the retention or disposition of the radiographs and other records pertaining to the X‑ray examinations.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-1.0** Purpose and Scope {#sec-4465-1.0 omnilex-key=us-de-regs-official--title-16--4465-1.0}

This part provides for the licensing of radioactive material, for purposes of protecting the public health and safety. No person shall receive, possess, use, transfer, sell, own or acquire radioactive material except as authorized in a specific or general license per the U.S. Nuclear Regulatory Commission (NRC), in accordance with Title 10 – Code of Federal Regulations. Primary radioactive material licensing and enforcement authority was transferred to the NRC in 2007, pursuant to the Federal Energy Policy Act of 2005. However, radioactive material facilities must be registered with the State of Delaware in accordance with Regulation 4465, Part B of these regulations.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-1.0** Purpose & General Provisions {#sec-4465-1.0 omnilex-key=us-de-regs-official--title-16--4465-1.0}

1.1 Part D establishes standards for protection against ionizing radiation resulting from activities conducted pursuant to licenses or registrations issued by the Agency. This regulation are issued pursuant to the Title 16, Delaware Code, Chapter 74 Radiation Control.

1.2 The requirements of Part D are designed to control the receipt, possession, use, sale, transfer, and disposal of sources of radiation by any licensee or registrant so the total dose to an individual, including doses resulting from all sources of radiation other than background radiation, does not exceed the standards for protection against radiation prescribed in Part D. However, nothing in Part D shall be construed as limiting actions that may be necessary to protect health and safety.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-2.0** Scope {#sec-4465-2.0 omnilex-key=us-de-regs-official--title-16--4465-2.0}

Except as specifically provided in other Parts of this regulation, Part D applies to persons licensed or registered by the Agency to receive, possess, use, sell, transfer, or dispose of sources of radiation. The limits in Part D do not apply to doses due to background radiation, to exposure of patients to radiation for the purpose of medical diagnosis or therapy, to exposure from individuals administered radioactive material and released in accordance with the providers ALARA license conditions, or to voluntary participation in medical research programs.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-3.0** Definitions {#sec-4465-3.0 omnilex-key=us-de-regs-official--title-16--4465-3.0}

As used in Part D:

"A1" means the maximum activity of special form radioactive material permitted in a Type A package.

"A2" means the maximum activity of radioactive material, other than special form radioactive material, permitted in a Type A package.

These values are either listed in Appendix A of Part T of these regulations, Table I, or may be derived in accordance with the procedure prescribed in Appendix A of Part T of these regulations.

“Absorbed dose” means the energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the gray (Gy) and the rad.

“Accelerator” means any machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and of discharging the resultant particulate or other radiation into a medium at energies usually in excess of 1 MeV. For purposes of this definition, "particle accelerator" is an equivalent term.

“Accelerator-produced material” means any material made radioactive by a particle accelerator.

“Activity” means the rate of disintegration or transformation or decay of radioactive material. The units of activity are the becquerel (Bq) and the curie (Ci).

“Address of use” means the building or buildings that are identified on the permit (license) and where radioactive materials may be produced, prepared, received, used, or stored.

"Adult" means an individual 18 or more years of age.

“Agency” means the Division of Public Health, Delaware Department of Health and Social Services.

“Agreement state” means any state with which the Nuclear Regulatory Commission or the Atomic Energy Commission has entered into an effective agreement under subsection 274b. of the Atomic Energy Act of 1954, as amended (73 Stat. 689).

“Airborne radioactive material” means any radioactive material dispersed in the air in the form of dusts, fumes, particulates, mists, vapors, or gases.

“Airborne radioactivity area” means a room, enclosure, or area in which airborne radioactive materials exist in concentrations:

(1) In excess of the derived air concentrations (DAC's) specified in Appendix B, Table I of Part D of these regulations; or

(2) To such a degree that an individual present in the area without respiratory protective equipment could exceed, during the hours an individual is present in a week, an intake of 0.6% of the annual limit on intake (ALI) or 12 DAC-hours.

“Airline respirator” (see "Supplied-air respirator (SAR)").

“Air-purifying respirator” means a respirator with an air-purifying filter, cartridge, or canister that removes specific air contaminants by passing ambient air through the air-purifying element.

“Annual limit on intake (ALI)” means the derived limit for the amount of radioactive material taken into the body of an adult worker by inhalation or ingestion in a year. ALI is the smaller value of intake of a given radionuclide in a year by the reference man that would result in a committed effective dose equivalent of 5 rems (0.05 Sv) or a committed dose equivalent to 50 rems (0.5 Sv) to any individual organ or tissue. (ALI values for intake by ingestion and by inhalation of selected radionuclides are given in Appendix B of this regulation.

“As low as is reasonably achievable” (ALARA) means making every reasonable effort to maintain exposures to radiation as far below the dose limits in these regulations as is practical, consistent with the purpose for which the licensed or registered activity is undertaken, taking into account the state of technology, the economics of improvements in relation to state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to utilization of nuclear energy and licensed or registered sources of radiation in the public interest.

“Assigned protection factor (APF)” means the expected workplace level of respiratory protection that would be provided by a properly functioning respirator or a class of respirators to properly trained and fitted users. Operationally, the inhaled concentration can be estimated by dividing the ambient airborne concentration by the APF.

“Atmosphere-supplying respirator” means a respirator that supplies the respirator user with breathing air from a source independent of the ambient atmosphere, and includes supplied-air respirators (SAR’s) and self-contained breathing apparatus (SCBA) units.

“Authorized user” means a practitioner of the healing arts who is identified as an authorized user on an Agency, agreement state, licensing state or the Nuclear Regulatory Commission license that authorizes the medical use of radioactive material.

“Background radiation” means radiation from cosmic sources, naturally occurring radioactive material, (which has not been technologically enhanced) including radon, except as a decay product of source or special nuclear material, and including global fallout as it exists in the environment from the testing of nuclear explosive devices, or from past nuclear accidents such as Chernobyl that contribute to background radiation and are not under the control of the licensee or registrant. "Background radiation" does not include sources of radiation from radioactive materials regulated by the Agency.

"Becquerel" (Bq) means the Standard Internationale (SI) unit of activity. One becquerel is equal to 1 disintegration or transformation per second (dps or tps).

"Bioassay" means the determination of kinds, quantities or concentrations, and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body. For purposes of this regulation, "radiobioassay" is an equivalent term.

"Brachytherapy" means a method of radiation therapy in which radiation sources are utilized to deliver a radiation dose at a distance of up to a few centimeters, by surface, intracavitary, intraluminal, or interstitial application.

"Byproduct material" means:

(1) Any radioactive material (except special nuclear material) yielded in, or made radioactive by, exposure to the radiation incident to the process of producing or using special nuclear material;

(2) The tailings or wastes produced by the extraction or concentration of uranium or thorium from ore processed primarily for its source material content, including discrete surface wastes resulting from uranium solution extraction processes. Underground ore bodies depleted by these solution extraction operations do not constitute "byproduct material" within this definition;

(3) (i) Any discrete source of radium-226 that is produced, extracted, or converted after extraction, before, on, or after August 8, 2005, for use for a commercial, medical, or research activity; or

(ii) Any material that—

(A) Has been made radioactive by use of a particle accelerator; and

(B) Is produced, extracted, or converted after extraction, before, on, or after August 8, 2005, for use for a commercial, medical, or research activity; and

(4) Any discrete source of naturally occurring radioactive material, other than source material, that—

(i) The Commission, in consultation with the Administrator of the Environmental Protection Agency, the Secretary of Energy, the Secretary of Homeland Security, and the head of any other appropriate Federal agency, determines would pose a threat similar to the threat posed by a discrete source of radium-226 to the public health and safety or the common defense and security; and

(ii) Before, on, or after August 8, 2005, is extracted or converted after extraction for use in a commercial, medical, or research activity.

“Calendar quarter” means not less than 12 consecutive weeks nor more than 14 consecutive weeks. The first calendar quarter of each year shall begin in January and subsequent calendar quarters shall be so arranged such that no day is included in more than 1 calendar quarter and no day in any 1 year is omitted from inclusion within a calendar quarter. The method observed by the licensee or registrant for determining calendar quarters shall only be changed at the beginning of a year.

“Calibration” means the determination of (1) the response or reading of an instrument relative to a series of known radiation values over the range of the instrument, or (2) the strength of a source of radiation relative to a standard.

“CFR” means Code of Federal Regulations.

“Chiropractic” means a drugless system of health care based on the principle that interference with the transmission of nerve impulses may cause disease, per Title 24 Delaware Code, Chapter 7, Board of Chiropractic, as amended.

“Class (or lung class or inhalation class)” means a classification scheme for inhaled material according to its rate of clearance from the pulmonary region of the lung. Materials are classified as D, W, or Y, which applies to a range of clearance half-times: for Class D (Days) of less than 10 days, for Class W (Weeks) from 10 to 100 days, and for Class Y (Years) of greater than 100 days.

“Collective dose” means the sum of the individual doses received in a given period of time by a specified population from exposure to a specified source of radiation.

“Committed dose equivalent” (HT.50) means the dose equivalent to organs or tissues of reference (T) that will be received from an intake of radioactive material by an individual during the 50-year period following the intake.

“Committed effective dose equivalent” (HE.50) is the sum of the products of the weighting factors (wT) applicable to each of the body organs or tissues that are irradiated and the committed dose equivalent to each of these organs or tissues (HE,50 = Σ wT HT,50).

“Constraint (dose constraint)” means a value above which specified licensee actions are required.

“Controlled area” means an area, outside of a restricted but inside the site boundary, access to which can be limited by the licensee or registrant, for any reason.

“Critical group” means the group of individuals reasonably expected to receive the greatest exposure to residual radioactivity for any applicable set of circumstances.

“Curie” means the traditional unit of quantity of activity. One curie (Ci) is that quantity of radioactive material, which decays at the rate of 3.7E+10 disintegrations or transformations per second (dps or tps).

“Declared pregnant woman” means a woman who has voluntarily informed the licensee, in writing, of her pregnancy and the estimated date of conception. The declaration remains in effect until the declared pregnant woman withdraws the declaration in writing or is no longer pregnant.

“Deep dose equivalent” (Hd), which applies to external whole body exposure, means the dose equivalent at a tissue depth of 1 centimeter (1000 mg/cm2).

“Demand respirator” means an atmosphere-supplying respirator that admits breathing air to the face piece only when a negative pressure is created inside the facepiece by inhalation

“Dentist” shall mean a person who is qualified to practice dentistry as prescribed in Title 24 Delaware Code, Chapter 11, Dentistry and Dental Hygiene, as amended.

“Department of Energy” means the Department of Energy established by Public Law 95-91, August 4, 1977, 91 Stat. 565, 42 U.S.C. Section 7101 as amended et seq., to the extent that the Department exercises functions formerly vested in the Atomic Energy Commission, its Chairman, members, officers and components and transferred to the Energy Research and Development Administration and to the Administrator thereof pursuant to sections 104(b), (c) and (d) of the Energy Reorganization Act of 1974 (Public Law 93-438, October 11, 1974, 88 Stat. 1233 at 1237, 42 U.S.C. 5814, effective January 19, 1975) and re-transferred to the Secretary of Energy pursuant to section 301(a) of the Department of Energy Organization Act (Public Law 95-91, August 4, 1977, 91 Stat. 565 at 577-578, 42 U.S.C. 7151, effective October 1, 1977 as amended.)

"Depleted uranium" means the source material uranium in which the isotope uranium-235 is less than 0.711 weight percent of the total uranium present. Depleted uranium does not include special nuclear material.

“Derived air concentration (DAC)” means the concentration of a given radionuclide in air which, if breathed by the reference man for a working year of 2,000 hours under conditions of light work (inhalation rate 1.2 cubic meters of air per hour), results in an intake of 1 ALI. DAC values are given in Appendix B of this regulation.

“Discrete Source” means a radionuclide that has been processed so that its concentration within a material has been purposely increased for use for commercial, medical, or research activities.

"Disposable respirator" means a respirator for which maintenance is not intended and that is designed to be discarded after excessive breathing resistance, sorbent exhaustion, physical damage, or end-of-service-life renders it unsuitable for use. Examples of this type of respirator are a disposable half-mask respirator or a disposable escape-only self-contained breathing apparatus (SCBA).

"Distinguishable from background" means that the detectable concentration of a radionuclide is statistically different from the background concentration of that radionuclide in the vicinity of the site or, in the case of structures, in similar materials using adequate measurement technology, survey, and statistical techniques.

"Dose" is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed dose equivalent, committed effective dose equivalent, total organ dose equivalent, or total effective dose equivalent. For purposes of these regulations, "radiation dose" is an equivalent term.

"Dose equivalent (HT)" means the product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the sievert (Sv) and rem.

"Dose limits" means the permissible upper bounds of radiation doses established in accordance with these regulations. For purposes of this regulation, "limits" is an equivalent term.

"Effective dose equivalent (HE)" means the sum of the products of the dose equivalent to the organ or tissue (HT) and the weighting factor (wT) applicable to each of the body organs or tissues that are irradiated (HE = Σ wTHT).

"Embryo/fetus" means the developing human organism from conception until the time of birth.

"Exposure" generally means being exposed to ionizing radiation or to radioactive material.

"Exposure rate" means the exposure per unit of time, such as roentgen per minute or milliroentgen per hour.

"Exposure units" specifically as used in these regulations, the SI unit of exposure is coulomb per kilogram (C/kg), see Section 9.1 of Part A for Units of Exposure and Dose.

"External dose" means that portion of the dose equivalent received from any source of radiation outside the body.

“External source” means all ionizing radiation sources that could present exposure or external dose to an individual.

"Extremity" means hand, elbow, and arm below the elbow, foot, knee, and leg below the knee.

“Facility” means the location, building vehicle, or complex under 1 administrative control, at which 1 or more radiation sources are installed, located and/or used.

"Filtering facepiece (dust mask)" means a negative pressure particulate respirator with a filter as an integral part of the facepiece or with the entire facepiece composed of the filtering medium, not equipped with elastomeric sealing surfaces and adjustable straps.

"Fit factor" means a quantitative estimate of the fit of a particular respirator to a specific individual, and typically estimates the ratio of the concentration of a substance in ambient air to its concentration inside the respirator when worn.

"Fit test" means the use of a protocol to qualitatively evaluate the fit of a respirator on an individual.

"Former Atomic Energy Commission or Nuclear Regulatory Commission licensed facilities" means nuclear reactors, nuclear fuel reprocessing plants, uranium enrichment plants, or critical mass experimental facilities where Atomic Energy Commission or Nuclear Regulatory Commission licenses have been terminated.

"Generally applicable environmental radiation standards" means standards issued by the Environmental Protection Agency under the authority of the Atomic Energy Act of 1954, as amended, that impose limits on radiation exposures or levels, or concentrations or quantities of radioactive material, in the general environment outside the boundaries of locations under the control of persons possessing or using radioactive material.

"Gray" (Gy) means the Standard Internationale (SI) unit of absorbed dose. One gray is equal to an absorbed dose of 1 joule per kilogram (100 rad).

"Hazardous waste" means those wastes designated as hazardous by the Environmental Protection Agency regulations in 40 CFR Part 261, as amended.

“Healing arts” includes but is not limited to the practice of medicine, surgery, dentistry, registered pharmacy, podiatry, osteopathy, chiropractic, or veterinary medicine or nursing.

“Healing arts screening” means the testing of human beings using X-ray machines for the detection or evaluation of health indications when such tests are not specifically and individually ordered by a licensed practitioner of the healing arts legally authorized to prescribe such X-ray tests for the purpose of diagnosis or treatment.

"Helmet" means a rigid respiratory inlet covering that also provides head protection against impact and penetration.

"High radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of 1 mSv (0.1 rem) in 1 hour at 30 centimeters from any source of radiation or 30 centimeters from any surface that the radiation penetrates.

"Hood" means a respiratory inlet covering that completely covers the head and neck and may also cover portions of the shoulders and torso.

"Human use" means the internal or external administration of radiation or radioactive material to human beings.

"Individual" means any human being.

"Individual monitoring" means the assessment of:

(1) Dose equivalent (a) by the use of individual monitoring devices or (b) by the use of survey data; or

(2) Committed effective dose equivalent (a) by bioassay or (b) by determination of the time-weighted air concentrations to which an individual has been exposed, that is, DAC-hours. [See the definition of DAC-hours in 4465 Part D of these regulations.]

(3) Dose equivalent by the use of survey data.

"Individual monitoring devices" means devices designed to be worn by a single individual for the assessment of dose equivalent. For purposes of these regulations, "personnel dosimeter" and "dosimeter" are equivalent terms. Examples of individual monitoring devices are film badges, thermoluminescence dosimeters (TLDs), pocket ionization chambers, optically stimulated luminescence (OSL) dosimeters and personal (lapel) air sampling devices.

"Inspection" means an official examination or observation including, but not limited to, tests, surveys, and monitoring to determine compliance with rules, regulations, orders, requirements, and conditions of the Agency.

"Instrument traceability" (for ionizing radiation measurements) means the ability to show that an instrument has been calibrated at specified time intervals using a national standard or a transfer standard. If a transfer standard is used, the calibration must be at a laboratory accredited by a program, which requires continuing participation in measurement quality assurance with the National Institute of Standards and Technology, or other equivalent national or international program.

"Interlock" means a device arranged or connected such that the occurrence of an event or condition is required before a second event or condition can occur or continue to occur.

"Internal dose" means that portion of the dose equivalent received from radioactive material taken into the body.

"JRCERT" means Joint Review Committee on Education in Radiologic Technology.

“JRCNMT” means Joint Review Committee on Nuclear Medicine Technology.

"Lens dose equivalent (LDE)" means the external exposure to the lens of the eye as the dose equivalent at a tissue depth of 0.3 centimeter (300 mg/cm2).

"License" means a license issued by the US Nuclear Regulatory Commission, agreement state, or the Agency, in accordance with applicable federal or state regulations, as amended.

"Licensed practitioner" means an individual licensed to practice medicine, dentistry, podiatry, chiropractic, osteopathy, or veterinary medicine in this state. For the purpose of this regulation, advanced practice registered nurses (APRNs) and physicians assistants (PAs) may order diagnostic or supportive X-ray procedures for patients in accordance with Title 24, Delaware Code. APRNs and PAs who supervise, perform, view, or interpret X-ray procedures do so within their scope of practice, as governed by Title 24, Delaware Code.

"Licensed [or registered] material" means radioactive material received, possessed, used, transferred or disposed of under a general or specific license [or registration] issued by the Agency.

"Licensee" means the holder of a license.

"Limits" [See "dose limits"].

"Loose-fitting facepiece" means a respiratory inlet covering that is designed to form a partial seal with the face.

"Lost or missing source of radiation" means licensed [or registered] source of radiation whose location is unknown. This definition includes, but is not limited to, radioactive material that has been shipped but has not reached its planned destination and whose location cannot be readily traced in the transportation system.

"Major processor" means a user processing, handling, or manufacturing radioactive material exceeding Type A quantities as unsealed sources or material, or exceeding 4 times Type B quantities as sealed sources, but does not include nuclear medicine programs, universities, industrial radiographers, or small industrial programs. Type A and B quantities, as defined by the federal Nuclear Regulatory Commission.

"Member of the public" means any individual except when that individual is receiving an occupational dose.

"Minor" means an individual less than 18 years of age.

“Misadministration” means an event that meets the criteria in 4465 Part X, Therapeutic Radiation Machines, Section 5.2 of these regulations.

"Monitoring" means the measurement of radiation, radioactive material concentrations, surface area activities or quantities of radioactive material and the use of the results of these measurements to evaluate potential exposures and doses. For purposes of these regulations, "radiation monitoring" and "radiation protection monitoring" are equivalent terms.

"Natural radioactivity" means radioactivity of naturally occurring nuclides.

"Negative pressure respirator (tight fitting)" means a respirator in which the air pressure inside the facepiece is negative during inhalation with respect to the ambient air pressure outside the respirator.

"NORM" means any naturally occurring radioactive material. It does not include byproduct, source, or special nuclear material.

"NRC" means the US Nuclear Regulatory Commission or its duly authorized representatives.

“Notice of violation” means a written statement of 1 or more alleged infringements of a legally binding requirement. The notice normally requires the licensee, registrant or other permit holder to provide a written statement describing the following:

Corrective steps taken by the licensee, registrant or other permit holder and the results achieved;

Corrective steps to be taken to prevent recurrence; and

The projected date for achieving full compliance. The Authority may require responses to notices of violation to be under oath.

"Occupational dose" means the dose received by an individual in the course of employment, education or training, in which the individual's assigned duties for the licensee or registrant involve exposure to sources of radiation, whether or not the sources of radiation are in the possession of the licensee, registrant, or other person. Occupational dose does not include doses received from background radiation, or from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with U.S. Nuclear Regulatory Commission Regulations, from voluntary participation in medical research programs, or as a member of the public.

“Office of Engineering” means the office in the Delaware Division of Public Health that reviews radiation shielding plans and/or design plans and issues an Approval to Construct letter for new radiation source facilities or rooms.

“Office of Radiation Control” means the office in the Delaware Division of Public Health which carries out the Delaware Radiation Control Regulations, issues radiation source facility registration permits, and performs on-site inspections of new and existing radiation machine facilities to determine compliance.

“Owner/leasee” means the person/individual who owns/leases the radiation source. An out-of-state owner shall authorize a manager to sign the application form.

"Package" means the packaging together with its radioactive contents as presented for transport.

"Particle accelerator" [See "accelerator"].

"Person" means any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, agency, political subdivision of this State, any other state or political subdivision or agency thereof, and any legal successor, representative, agent, or agency of the foregoing, [but shall not include federal government agencies].

"Personnel monitoring equipment" [See "individual monitoring devices"].

"Physician" means an allopathic doctor of medicine and surgery or a doctor of osteopathic medicine and surgery who is registered and certified to practice medicine pursuant to Title 24 Delaware Code, Chapter 17, Medical Practice Act, as amended.

“Planned special exposure” means an infrequent exposure to radiation, separate from and in addition to the annual dose limits.

“Podiatrist” means a person who is qualified to practice podiatry and is licensed under Title 24 Delaware Code, Chapter 5, Podiatry, as amended.

"Positive pressure respirator" means a respirator in which the pressure inside the respiratory inlet covering exceeds the ambient air pressure outside the respirator.

"Powered air-purifying respirator (PAPR)" means an air-purifying respirator that uses a blower to force the ambient air through air-purifying elements to the inlet covering.

"Pressure demand respirator" means a positive pressure atmosphere-supplying respirator that admits breathing air to the facepiece when the positive pressure is reduced inside the facepiece by inhalation.

“Principal supervisor” means the licensed practitioner responsible for initiating use of X-ray equipment or other device generating ionizing radiation in the healing arts.

"Protective apron" means an apron made of radiation-attenuating materials used to reduce exposure to radiation.

"Public dose" means the dose received by a member of the public from exposure to sources of radiation released by the licensee or registrant, or to any other source of radiation under the control of the licensee or registrant. Public dose does not include occupational dose, or doses received from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with U.S. Nuclear Regulatory Commission Regulations, or from voluntary participation in medical research programs.

“Qualified expert” means an individual who has satisfactorily fulfilled the training and experience requirements consistent with achieving a level of competency sufficient to function effectively in the position for which registration is sought. Such individuals must demonstrate to the satisfaction of the Agency their qualifications, for example, individuals certified in the appropriate field by the American Board of Radiology, or the American Board of Health Physics, or the American Board of Medical Physics, or those having equivalent qualifications. With reference to the calibration of radiation therapy equipment, an individual, in addition to the above qualifications, must be qualified in accordance with 4465 Part F and 4465 Part X of this regulation, as amended.

"Qualified medical physicist (QMP)" means an individual who meets each of the following credentials:

1. Has earned a master's and/or doctoral degree in physics, medical physics, biophysics, radiological physics, medical health physics, or equivalent disciplines from an accredited college or university; and

2. Has been granted certification in the specific subfield(s) of medical physics with its associated medical health physics aspects by an appropriate national certifying body and abides by the certifying body's requirements for continuing education; and/or

3. Is credentialed in accordance with Regulation 4465, Part X, Therapeutic Radiation machines, subsection 3.4, as amended.

“Qualitative fit test (QLFT)" means a pass/fail fit test to assess the adequacy of respirator fit that relies on the individual’s response to the test agent.

"Quality factor" (Q) means the modifying factor, listed in Tables I and II of Part A, Section 13.0, that is used to derive dose equivalent from absorbed dose.

"Quantitative fit test (QNFT)" means an assessment of the adequacy of respirator fit by numerically measuring the amount of leakage into the respirator.

"Rad" means the traditional unit of absorbed dose. One rad is equal to an absorbed dose of 100 erg per gram or 0.01 joule per kilogram (0.01 gray).

"Radiation" means alpha particles, beta particles, gamma rays, X-rays, neutrons, high-speed electrons, high-speed protons, and other particles capable of producing ions. For purposes of these regulations, ionizing radiation is an equivalent term. Radiation, as used in these regulations, does not include non-ionizing radiation, such as radiowaves or microwaves, visible, infrared, or ultraviolet light.

"Radiation area" means any area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 0.05 mSv (0.005 rem) in 1 hour at 30 centimeters from the source of radiation or from any surface that the radiation penetrates.

"Radiation dose" [See "Dose"].

"Radiation machine" means any device capable of producing ionizing radiation except those devices with radioactive material as the only source of radiation.

“Radiation safety officer” or RSO for a radiation machine facility means an individual assigned to perform RSO duties who has training and experience in the safe and effective use of radiation machines, their potential radiation hazards, and emergency precautions applicable to the type of activity or facility to which the RSO is assigned.

"Radiation technician" means any individual who has not graduated from an approved program in radiation technology, but has passed an Authority approved examination.

"Radiation technologist" means any individual who has successfully completed a JRCERT or JRCNMT approved program in radiation technology and has passed a national certification examination in his or her field of specialization.

"Radiation technology" means the use of a radioactive substance or equipment emitting ionizing radiation on humans for diagnostic or therapeutic purposes.

"Radioactive material" means any solid, liquid or gas which emits radiation spontaneously.

"Radioactivity" means the transformation of unstable atomic nuclei by the emission of radiation.

"Radiobioassay" [See "Bioassay"].

"Registrant" means any person who is registered with the Agency and is legally obligated to register with the Agency pursuant to these regulations and the Act.

“Registration" means registration with the Agency in accordance with the regulations adopted by the Agency.

"Regulations of the Department of Transportation" means the regulations in 49 CFR Parts 100-189, as amended.

"Rem" means the traditional unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem is equal to the absorbed dose in rad multiplied by the quality factor. (1 rem = 0.01 Sv)

"Research and development" means (1) theoretical analysis, exploration, or experimentation; or (2) the extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials, and processes. Research and development does not include the internal or external administration of radiation or radioactive material to human beings in the healing arts.

"Residual radioactivity" means radioactivity in structures, materials, soils, groundwater, and other media at a site resulting from activities under the licensee’s control. This includes radioactivity from all licensed and unlicensed sources used by the licensee, but excludes background radiation. It also includes radioactive materials remaining at the site as a result of routine or accidental releases of radioactive materials at the site and previous burials at the site, even if those burials were made in accordance with the provisions of Part D of these regulations.

"Restricted area" means an area, access to which is limited by the licensee or registrant for the purpose of protecting individuals against undue risks from exposure to sources of radiation. Restricted area does not include areas used as residential quarters, but separate rooms in a residential building may be set apart as a restricted area.

"Roentgen" means the traditional unit of exposure. One roentgen (R) equals 2.58E-4 coulombs per kilogram of air (see "Exposure" and Part A, subsection 9.1).

“State Radiation Control Act” or “the Act” means Title 16 Delaware Code, Chapter 74, Radiation Control, as amended.

"Sealed source" means any encapsulated radioactive material, which has been constructed in such a manner as to prevent the escape of any radioactive material.

"Sealed Source and Device Registry (SSD)" means the national registry that contains the registration certificates, maintained by the Nuclear Regulatory Commission (NRC), that summarize the radiation safety information for sealed sources and devices, and describe the licensing and use conditions approved for the product.

"Self-contained breathing apparatus (SCBA)" means an atmosphere-supplying respirator for which the breathing air source is designed to be carried by the user.

"Shallow dose equivalent" (Hs), which applies to the external exposure of the skin or an extremity, means the dose equivalent at a tissue depth of 0.007 centimeter (7 mg/cm2) averaged over the contiguous 10 square centimeters of skin receiving the highest exposure.

"SI" means the abbreviation for Standard Internationale, the International Metric System of Measurement.

"Sievert" means the Standard Internationale (SI) unit of any of the quantities expressed as dose equivalent. The dose equivalent in sievert is equal to the absorbed dose in gray multiplied by the quality factor. (1 Sv = 100 rem)

"Source material" means:

(1) Uranium or thorium, or any combination thereof, in any physical or chemical form; or

(2) Ores that contain by weight 1/20 of 1 percent (0.05 percent) or more of uranium, thorium or any combination of uranium and thorium. Source material does not include special nuclear material.

"Source material milling" means any activity that results in the production of byproduct material as defined by definition (2) of byproduct material, of this part.

"Source of radiation" means any radioactive material or any device or equipment emitting, or capable of producing, radiation.

"Source traceability" means the ability to show that a radioactive source has been calibrated either by the national standards laboratory of the National Institute of Standards and Technology, or by a laboratory which participates in a continuing measurement quality assurance program with National Institute of Standards and Technology or other equivalent national or international program.

"Special form radioactive material" means radioactive material that satisfies the following conditions:

(1) It is either a single solid piece or is contained in a sealed capsule that can be opened only by destroying the capsule;

(2) The piece or capsule has at least 1 dimension not less than 5 millimeters (0.2 inch); and

(3) It satisfies the test requirements specified by the Nuclear Regulatory Commission. A special form encapsulation designed in accordance with the Nuclear Regulatory Commission requirements in effect on June 30, 1983, and constructed prior to July 1, 1985, may continue to be used. A special form encapsulation either designed or constructed after June 30, 1985, must meet requirements of this definition applicable at the time of its design or construction.

"Special nuclear material" means:

(1) Plutonium, uranium-233, uranium enriched in the isotope 233 or in the isotope 235, and any other material that the Nuclear Regulatory Commission, pursuant to the provisions of section 51 of the Atomic Energy Act of 1954, as amended, determines to be special nuclear material, but does not include source material; or

(2) Any material artificially enriched by any of the foregoing but does not include source material.

"Special nuclear material in quantities not sufficient to form a critical mass" means uranium enriched in the isotope U-235 in quantities not exceeding 350 grams of contained U-235; uranium-233 in quantities not exceeding 200 grams; plutonium in quantities not exceeding 200 grams; or any combination of them in accordance with the following formula:

For each kind of special nuclear material, determine the ratio between the quantity of that special nuclear material and the quantity specified above for the same kind of special nuclear material.

The sum of such ratios for all of the kinds of special nuclear material in combination shall not exceed 1. For example, the following quantities in combination would not exceed the limitation and are within the formula:

“Standard Internationale (SI)” means the international metric systems of measurement.

"Supplied-air respirator (SAR)" means an atmosphere-supplying respirator for which the source of breathing air is not designed to be carried by the user.

"Survey" means an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal, or presence of sources of radiation. When appropriate, such evaluation includes, but is not limited to, tests, physical examinations, and measurements of levels of radiation or concentrations of radioactive material present.

"Test" means the process of verifying compliance with an applicable regulation.

"These regulations" means all parts of The Delaware Radiation Control Regulations 4465, as amended.

"Tight-fitting facepiece" means a respiratory inlet covering that forms a complete seal with the face.

"Total effective dose equivalent" (TEDE) means the sum of the deep dose equivalent for external exposures and the committed effective dose equivalent for internal exposures.

"Total organ dose equivalent" (TODE) means the sum of the deep dose equivalent and the committed dose equivalent to the organ receiving the highest dose as described in subsection 39.1.6 of these regulations.

"Traceable to a National Standard" [See "Instrument traceability" or "Source traceability"].

"Unrefined and unprocessed ore" means ore in its natural form prior to any processing such as grinding, roasting, beneficiating, or refining.

"Unrestricted area" means an area, access to which is neither limited nor controlled by the licensee or registrant. For purposes of these regulations, "uncontrolled area" is an equivalent term.

"User seal check (fit check)" means an action conducted by the respirator user to determine if the respirator is properly seated to the face. Examples include negative pressure check, positive pressure check, irritant smoke check, or isoamyl acetate check.

"Very high radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving an absorbed dose in excess of 500 rads (5 grays) in 1 hour at 1 meter from a source of radiation or 1 meter from any surface that the radiation penetrates.12/

“Veterinarian” shall mean a person who has received a degree in veterinary medicine from a school of veterinary medicine, per Title 24 Delaware Code, Chapter 33, Veterinarians, as amended.

"Waste" means those low-level radioactive wastes that are acceptable for disposal in a land disposal facility. For the purposes of this definition, low-level waste has the same meaning as in the Low-Level Radioactive Waste Policy Act, P.L. 96-573, as amended by P.L. 99-240, effective January 15, 1986; that is, radioactive waste (a) not classified as high-level radioactive waste, spent nuclear fuel, or byproduct material as defined in Section 11e.(2) of the Atomic Energy Act, as amended (uranium or thorium tailings and waste) and (b) classified as low-level radioactive waste consistent with existing law and in accordance with (a) by the Nuclear Regulatory Commission.

"Waste handling licensees" mean persons licensed to receive and store radioactive wastes prior to disposal and/or persons licensed to dispose of radioactive waste.

"Week" means 7 consecutive days starting on Sunday.

"Whole body" means, for purposes of external exposure, head, trunk including male gonads, arms above the elbow, or legs above the knee.

"Worker" means an individual engaged in activities under a license or registration issued by the Agency and controlled by a licensee or registrant, including but not limited to employees, but does not include the licensee or registrant.

"Working level" (WL) means any combination of short-lived radon daughters in 1 liter of air that will result in the ultimate emission of 1.3E+5 MeV of potential alpha particle energy. The short-lived radon daughters of radon-222 are polonium-218, lead-214, bismuth-214, and polonium-214; and those of radon-220 are polonium-216, lead-212, bismuth-212, and polonium-212.

"Working level month" (WLM) means an exposure to 1 working level for 170 hours. 2,000 working hours per year divided by 12 months per year is approximately equal to 170 hours per month.

"Year" means the period of time beginning in January used to determine compliance with the provisions of these regulations. The licensee or registrant may change the starting date of the year used to determine compliance by the licensee or registrant provided that the change is made at the beginning of the year. If a licensee or registrant changes in a year, the licensee or registrant shall assure that no day is omitted or duplicated in consecutive years.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-4.0** Implementation {#sec-4465-4.0 omnilex-key=us-de-regs-official--title-16--4465-4.0}

4.1 Any existing license or registration condition that is more restrictive than Part D remains in force until there is an amendment or renewal of the license or registration.

4.2 If a license or registration condition exempts a licensee or registrant from a provision of Part D in effect on or before the effective date of these regulations, it also exempts the licensee or registrant from the corresponding provision of Part D.

4.3 If a license or registration condition cites provisions of Part D in effect prior to the effective date of these regulations, which do not correspond to any provisions of Part D, the license or registration condition remains in force until there is an amendment or renewal of the license or registration that modifies or removes this condition.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-5.0** Radiation Protection Programs {#sec-4465-5.0 omnilex-key=us-de-regs-official--title-16--4465-5.0}

5.1 Each licensee or registrant shall develop, document, and implement a radiation protection program sufficient to ensure compliance with the provisions of Section 35.0 for recordkeeping requirements relating to these programs.

5.2 The licensee or registrant shall use, to the extent practical, procedures and engineering controls based upon sound radiation protection principles to achieve occupational doses and doses to members of the public that are as low as is reasonably achievable (ALARA).

5.3 The licensee or registrant shall, at intervals not to exceed 12 months, review the radiation protection program content and implementation.

5.4 To implement the ALARA requirements of subsection 5.2, and notwithstanding the requirements in Section 13.0, a constraint on air emissions of radioactive material to the environment, excluding Radon-222 and its daughters, shall be established by licensees other than those subject to 10 CFR Part 50.34a of the USNRC regulations, such that the individual member of the public likely to receive the highest dose will not be expected to receive a total effective dose equivalent in excess of 0.1 millisievert (10 mrem) per year from these emissions. If a licensee subject to this requirement exceeds this dose constraint, the licensee shall report the exceedance as provided in Section 47.0 and promptly take appropriate corrective action to ensure against recurrence.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-6.0** Occupational Dose Limits for Adults {#sec-4465-6.0 omnilex-key=us-de-regs-official--title-16--4465-6.0}

6.1 The licensee or registrant shall control the occupational dose to individual adults, except for planned special exposures pursuant to Section 10.0, to the following dose limits:

6.1.1 An annual limit, which is the more limiting of:

6.1.1.1 The total effective dose equivalent being equal to 0.05 Sievert (5 rem, or 5000 millirem); or

6.1.1.2 The sum of the deep dose equivalent and the committed dose equivalent to any individual organ or tissue other than the lens of the eye being equal to 0.5 Sievert (50 rem, or 50,000 millirem).

6.1.2 The annual limits to the lens of the eye, to the skin, and to the extremities which are:

6.1.2.1 A lens dose equivalent of 0.15 Sievert (15 rem, or 15,000 millirem); and

6.1.2.2 A shallow dose equivalent of 0.5 Sievert (50 rem, or 50,000 millirem) to the skin or to any extremity.

6.2 Doses received in excess of the annual limits, including doses received during accidents, emergencies, and planned special exposures, shall be subtracted from the limits for planned special exposures that the individual may receive during the current year and during the individual's lifetime. See subsections 10.1.5.1 and 10.1.5.2.

6.3 The assigned deep dose equivalent and shallow dose equivalent shall be for the portion of the body receiving the highest exposure:

6.3.1 The deep dose equivalent, lens dose equivalent and shallow dose equivalent may be assessed from surveys or other radiation measurements for the purpose of demonstrating compliance with the occupational dose limits, if the individual monitoring device was not in the region of highest potential exposure, or the results of individual monitoring are unavailable; or

6.3.2 When a protective apron is worn while working with medical fluoroscopic equipment and monitoring is conducted as specified in subsection 17.1.1.5, the effective dose equivalent for external radiation shall be determined as follows:

6.3.2.1 When only 1 individual monitoring device is used and it is located at the neck (collar) outside the protective apron, the reported deep dose equivalent shall be the effective dose equivalent for external radiation;

6.3.2.2 When only 1 individual monitoring device is used and it is located at the neck (collar) outside the protective apron, and the reported dose exceeds 25% of the limit specified in subsection 6.1 the reported deep dose equivalent value multiplied by 0.30 shall be the effective dose equivalent for external radiation; or

6.3.2.3 When individual monitoring devices are worn, both under the protective apron at the waist and outside the protective apron at the neck, the effective dose equivalent for external radiation shall be assigned the value of the sum of the deep dose equivalent reported for the individual monitoring device located at the waist under the protective apron multiplied by 1.5 and the deep dose equivalent reported for the individual monitoring device located at the neck outside the protective apron multiplied by 0.04.

6.4 Derived air concentration (DAC) and annual limit on intake (ALI) values are specified in Table I of Appendix B and may be used to determine the individual's dose and to demonstrate compliance with the occupational dose limits. See Section 39.0.

6.5 In addition to the annual dose limits, the licensee or registrant shall limit the soluble uranium intake by an individual to 10 milligrams in a week in consideration of chemical toxicity. See footnote c/ of Appendix B.

6.6 The licensee or registrant shall reduce the dose that an individual may be allowed to receive in the current year by the amount of occupational dose received while employed by any other person during the current year. See Section 37.0.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-7.0** Compliance with Requirements for Summation of External and Internal Doses {#sec-4465-7.0 omnilex-key=us-de-regs-official--title-16--4465-7.0}

7.1 If the licensee or registrant is required to monitor pursuant to both subsections 17.1.1 and 17.1.2 the licensee or registrant shall demonstrate compliance with the dose limits by summing external and internal doses. If the licensee or registrant is required to monitor only pursuant to subsection 17.1.1 or only pursuant to subsection 17.1.2, then summation is not required to demonstrate compliance with the dose limits. The licensee or registrant may demonstrate compliance with the requirements for summation of external and internal doses pursuant to subsections 7.2, 7.3 and 7.4. The dose equivalents for the lens of the eye, the skin, and the extremities are not included in the summation, but are subject to separate limits.

7.2 Intake by Inhalation. If the only intake of radionuclides is by inhalation, the total effective dose equivalent limit is not exceeded if the sum of the deep dose equivalent divided by the total effective dose equivalent limit, and one of the following, does not exceed unity:

7.2.1 The sum of the fractions of the inhalation ALI for each radionuclide; or

7.2.2 The total number of derived air concentration-hours (DAC- hours) for all radionuclides divided by 2,000; or

7.2.3 The sum of the calculated committed effective dose equivalents to all significantly irradiated organs or tissues (T) calculated from bioassay data using appropriate biological models and expressed as a fraction of the annual limit. For purposes of this requirement, an organ or tissue is deemed to be significantly irradiated if, for that organ or tissue, the product of the weighting factors, wT, and the committed dose equivalent, HT,50, per unit intake is greater than 10 percent of the maximum weighted value of HT,50, that is, wTHT,50, per unit intake for any organ or tissue.

7.3 Intake by Oral Ingestion. If the occupationally exposed individual receives an intake of radionuclides by oral ingestion greater than 10% of the applicable oral ALI, the licensee or registrant shall account for this intake and include it in demonstrating compliance with the limits.

7.4 Intake through Wounds or Absorption through Skin. The licensee or registrant shall evaluate and, to the extent practical, account for intakes through wounds or skin absorption. The intake through intact skin has been included in the calculation of DAC for hydrogen-3 and does not need to be evaluated.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-8.0** Determination of External Dose from Airborne Radioactive Material {#sec-4465-8.0 omnilex-key=us-de-regs-official--title-16--4465-8.0}

8.1 Licensees or registrants shall, when determining the dose from airborne radioactive material, include the contribution to the deep dose equivalent, lense dose equivalent, and shallow dose equivalent from external exposure to the radioactive cloud. See Appendix B, footnotes a/ and b/.

8.2 Airborne radioactivity measurements and DAC values shall not be used as the primary means to assess the deep dose equivalent when the airborne radioactive material includes radionuclides other than noble gases or if the cloud of airborne radioactive material is not relatively uniform. The determination of the deep dose equivalent to an individual shall be based upon measurements using instruments or individual monitoring devices.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-9.0** Determination of Internal Exposure {#sec-4465-9.0 omnilex-key=us-de-regs-official--title-16--4465-9.0}

9.1 For purposes of assessing dose used to determine compliance with occupational dose equivalent limits, the licensee or registrant shall, when required pursuant to Section 17.0, take suitable and timely measurements of:

9.1.1 Concentrations of radioactive materials in air in work areas;

9.1.2 Quantities of radionuclides in the body;

9.1.3 Quantities of radionuclides excreted from the body; or

9.1.4 Combinations of these measurements.

9.2 Unless respiratory protective equipment is used, as provided in Section 24.0, or the assessment of intake is based on bioassays, the licensee or registrant shall assume that an individual inhales radioactive material at the airborne concentration in which the individual is present.

9.3 When specific information on the physical and biochemical properties of the radionuclides taken into the body or the behavior of the material in an individual is known, the licensee or registrant may:

9.3.1 Use that information to calculate the committed effective dose equivalent, and, if used, the licensee or registrant shall document that information in the individual's record;

9.3.2 Upon prior approval of the Agency, adjust the DAC or ALI values to reflect the actual physical and chemical characteristics of airborne radioactive material, for example, aerosol size distribution or density; and

9.3.3 Separately assess the contribution of fractional intakes of Class D, W, or Y compounds of a given radionuclide to the committed effective dose equivalent. See Appendix B.

9.4 If the licensee or registrant chooses to assess intakes of Class Y material using the measurements given in subsection 9.1.2 or 9.1.3, the licensee or registrant may delay the recording and reporting of the assessments for periods up to 7 months, unless otherwise required by Sections 46.0 or 47.0. This delay permits the licensee or registrant to make additional measurements basic to the assessments.If the identity and concentration of each radionuclide in a mixture are known, the fraction of the DAC applicable to the mixture for use in calculating DAC- hours shall be either:

9.4.1 The sum of the ratios of the concentration to the appropriate DAC value, that is, D, W, or Y, from Appendix B for each radionuclide in the mixture; or

9.4.2 The ratio of the total concentration for all radionuclides in the mixture to the most restrictive DAC value for any radionuclide in the mixture.

9.5 If the identity of each radionuclide in a mixture is known, but the concentration of 1 or more of the radionuclides in the mixture is not known, the DAC for the mixture shall be the most restrictive DAC of any radionuclide in the mixture.

9.6 When a mixture of radionuclides in air exists, a licensee or registrant may disregard certain radionuclides in the mixture if:

9.6.1 The licensee or registrant uses the total activity of the mixture in demonstrating compliance with the dose limits in Section 6.0 and in complying with the monitoring requirements in subsection 7.2;

9.6.2 The concentration of any radionuclide disregarded is less than 10% of its DAC; and

9.6.3 The sum of these percentages for all of the radionuclides disregarded in the mixture does not exceed 30%.

9.7 When determining the committed effective dose equivalent, the following information may be considered:

9.7.1 In order to calculate the committed effective dose equivalent, the licensee or registrant may assume that the inhalation of 1 ALI, or an exposure of 2,000 DAC- hours, results in a committed effective dose equivalent of 0.05 Sievert (5 rem, or 5000 millirem) for radionuclides that have their ALIs or DACs based on the committed effective dose equivalent;

9.7.2 For an ALI and the associated DAC determined by the nonstochastic organ dose limit of 0.5 Sievert (50 rem, or 50,000 millirem), the intake of radionuclides that would result in a committed effective dose equivalent of 0.05 Sievert (5 rem, or 5000 millirem), that is, the stochastic ALI, is listed in parentheses in Table I of Appendix B. The licensee or registrant may, as a simplifying assumption, use the stochastic ALI to determine committed effective dose equivalent. However, if the licensee or registrant uses the stochastic ALI, the licensee or registrant shall also demonstrate that the limit in subsection 6.1.1.2 is met.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-10.0** Planned Special Exposures {#sec-4465-10.0 omnilex-key=us-de-regs-official--title-16--4465-10.0}

10.1 A licensee or registrant may authorize an adult worker to receive doses in addition to and accounted for separately from the doses received under the limits specified in Section 6.0 provided that each of the following conditions is satisfied:

10.1.1 The licensee or registrant authorizes a planned special exposure only in an exceptional situation when alternatives that might avoid the dose estimated to result from the planned special exposure are unavailable or impractical;

10.1.2 The licensee or registrant, and employer if the employer is not the licensee or registrant, specifically authorizes the planned special exposure, in writing, before the exposure occurs;

10.1.3 Before a planned special exposure, the licensee or registrant ensures that each individual involved is:

10.1.3.1 Informed of the purpose of the planned operation;

10.1.3.2 Informed of the estimated doses and associated potential risks and specific radiation levels or other conditions that might be involved in performing the task; and

10.1.3.3 Instructed in the measures to be taken to keep the dose ALARA considering other risks that may be present;

10.1.4 Prior to permitting an individual to participate in a planned special exposure, the licensee or registrant ascertains prior doses as required by subsection 37.2 during the lifetime of the individual for each individual involved;

10.1.5 Subject to subsection 6.2, the licensee or registrant shall not authorize a planned special exposure that would cause an individual to receive a dose from all planned special exposures and all doses in excess of the limits to exceed:

10.1.5.1 The numerical values of any of the dose limits in subsection 6.1 in any year; and

10.1.5.2 Five times the annual dose limits in subsection 6.1 during the individual's lifetime;

10.1.6 The licensee or registrant maintains records of the conduct of a planned special exposure in accordance with Section 38.0 and submits a written report in accordance with Section 48.0;

10.1.7 The licensee or registrant records the best estimate of the dose resulting from the planned special exposure in the individual's record and informs the individual, in writing, of the dose within 30 days from the date of the planned special exposure. The dose from planned special exposures shall not be considered in controlling future occupational dose of the individual pursuant to subsection 6.1 but shall be included in evaluations required by subsections 10.1.4 and 10.1.5.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-11.0** Occupational Dose Limits for Minors {#sec-4465-11.0 omnilex-key=us-de-regs-official--title-16--4465-11.0}

The annual occupational dose limits for minors are 10% of the annual occupational dose limits specified for adult workers in Section 6.0.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-12.0** Dose Equivalent to an Embryo/Fetus {#sec-4465-12.0 omnilex-key=us-de-regs-official--title-16--4465-12.0}

12.1 The licensee or registrant shall ensure that the dose equivalent to an embryo/fetus during the entire pregnancy, due to occupational exposure of a declared pregnant woman, does not exceed 5 millisievert (0.5 rem, or 500 millirem). See subsection 39.4 for recordkeeping requirements. See Appendix D for “Sample Letter for Declaring Pregnancy - Confidential, Protected Health Information”.

12.2 The licensee or registrant shall make efforts to avoid substantial variation*/ above a uniform monthly exposure rate to a declared pregnant woman so as to satisfy the limit in subsection 12.1.

12.3 The dose equivalent to the embryo/fetus is the sum of:

12.3.1 The deep dose equivalent to the declared pregnant woman; and

12.3.2 The dose equivalent resulting from radionuclides in the embryo/fetus and radionuclides in the declared pregnant woman.

12.4 If the dose equivalent to the embryo/fetus is found to have exceeded 5 millisieverts (0.5 rem, or 500 millirem), or is within 0.5 millisieverts (0.05 rem, or 50 millirem) of this dose, by the time the woman declares the pregnancy to the licensee or registrant, the licensee or registrant shall be deemed to be in compliance with subsection 12.1. if the additional dose to the embryo/fetus does not exceed 0.5 millisievert (0.05 rem, or 50 millirem) during the remainder of the pregnancy.

Radiation Dose Limits for

Individual Members of the Public

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-13.0** Dose Limits for Individual Members of the Public {#sec-4465-13.0 omnilex-key=us-de-regs-official--title-16--4465-13.0}

13.1 Each licensee or registrant shall conduct operations so that:

13.1.1 The total effective dose equivalent to individual members of the public from the licensed or registered operation does not exceed 1 millisievert (0.1 rem, or 100 millirem) in a year, exclusive of the dose contribution from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with their health care providers ALARA license conditions, from voluntary participation in medical research programs, and from the licensee's or registrant's disposal of radioactive material into sanitary sewerage in accordance with Part D, Section 33.0, and

13.1.2 The dose in any unrestricted area from external sources exclusive of the dose contributions from patients administered radioactive material and released in accordance with their health care providers ALARA license conditions, does not exceed 0.02 millisievert (0.002 rem, or 2 millirem) in any 1 hour; and

13.2 If the licensee or registrant permits members of the public to have access to restricted areas, the limits for members of the public continue to apply to those individuals.

13.3 A licensee, registrant, or an applicant for a license or registration may apply for prior Agency authorization to operate up to an annual dose limit for an individual member of the public of 5 millisievert (0.5 rem, or 500 millirem). This application shall include the following information:

13.3.1 Demonstration of the need for and the expected duration of operations in excess of the limit in subsection 13.1;

13.3.2 The licensee's or registrant's program to assess and control dose within the 5 millisieverts (0.5 rem or 500 millirem) annual limit; and

13.3.3 The procedures to be followed to maintain the dose as low as is reasonably achievable (ALARA).

13.4 In addition to the requirements of Part D, a licensee or registrant subject to the provisions of the Environmental Protection Agency's generally applicable environmental radiation standards in 40 CFR 190 shall comply with those standards.

13.5 The Agency may impose additional restrictions on radiation levels in unrestricted areas and on the total quantity of radionuclides that a licensee or registrant may release in effluents in order to restrict the collective dose.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-14.0** Compliance with Dose Limits for Individual Members of the Public {#sec-4465-14.0 omnilex-key=us-de-regs-official--title-16--4465-14.0}

14.1 The licensee or registrant shall make or cause to be made surveys of radiation levels in unrestricted areas and radioactive materials in effluents released to unrestricted areas to demonstrate compliance with the dose limits for individual members of the public in Section 13.0.

14.2 A licensee or registrant shall show compliance with the annual dose limit in Section 13.0 by:

14.2.1 Demonstrating by measurement or calculation that the total effective dose equivalent to the individual likely to receive the highest dose from the licensed or registered operation does not exceed the annual dose limit; or

14.2.2 Demonstrating that:

14.2.2.1 The annual average concentrations of radioactive material released in gaseous and liquid effluents at the boundary of the unrestricted area do not exceed the values specified in Table II of Appendix B; and

14.2.2.2 If an individual were continuously present in an unrestricted area, the dose from external sources would not exceed 0.02 millisievert (0.002 rem, or 2 millirem) in an hour and 0.5 millisievert (0.05 rem, or 50 millirem) in a year.

14.3 Upon approval from the Agency, the licensee or registrant may adjust the effluent concentration values in Appendix B, Table II, for members of the public, to take into account the actual physical and chemical characteristics of the effluents, such as aerosol size distribution, solubility, density, radioactive decay equilibrium, and chemical form.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-15.0** Testing for Leakage or Contamination of Sealed Sources {#sec-4465-15.0 omnilex-key=us-de-regs-official--title-16--4465-15.0}

The licensee or registrant in possession of any sealed source shall perform leak testing of sealed sources in accordance with their radioactive material license conditions.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-16.0** General Requirements for Surveys and Monitoring {#sec-4465-16.0 omnilex-key=us-de-regs-official--title-16--4465-16.0}

16.1 Each licensee or registrant shall make, or cause to be made, surveys that:

16.1.1 Are necessary for the licensee or registrant to comply with Part D; and

16.1.2 Are necessary under the circumstances to evaluate:

16.1.2.1 The magnitude and extent of radiation levels;

16.1.2.2 Concentrations or quantities of radioactive material; and

16.1.2.3 The potential radiological hazards.

16.2 The licensee or registrant shall ensure that instruments and equipment used for quantitative radiation measurements, for example, dose rate and effluent monitoring, are calibrated at intervals not to exceed 12 months for the radiation measured, except when a more frequent interval is specified in another applicable Part of these regulations or a license condition.

16.3 All personnel dosimeters, except for direct and indirect reading pocket ionization chambers and those dosimeters used to measure the dose to any extremity, that require processing to determine the radiation dose and that are used by licensees and registrants to comply with Section 6.0, with other applicable provisions of these regulations, or with conditions specified in a license or registration shall be processed and evaluated by a dosimetry processor:

16.3.1 Holding current personnel dosimetry accreditation from the National Voluntary Laboratory Accreditation Program of the National Institute of Standards and Technology; and

16.3.2 Approved in this accreditation process for the type of radiation or radiations included in the National Voluntary Laboratory Accreditation Program that most closely approximates the type of radiation or radiations for which the individual wearing the dosimeter is monitored.

16.4 The licensee or registrant shall ensure that adequate precautions are taken to prevent a deceptive exposure of an individual monitoring device.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-17.0** Conditions Requiring Individual Monitoring of External and Internal Occupational Dose {#sec-4465-17.0 omnilex-key=us-de-regs-official--title-16--4465-17.0}

17.1 Each licensee or registrant shall monitor exposures from sources of radiation at levels sufficient to demonstrate compliance with the occupational dose limits of Part D. As a minimum:

17.1.1 Each licensee or registrant shall monitor occupational exposure to radiation from radiation sources under its control and shall supply and require the use of individual monitoring devices by:

17.1.1.1 Adults likely to receive, in 1 year from sources external to the body, a dose in excess of 10% of the limits in subsection 6.1;

17.1.1.2 Minors likely to receive, in 1 year from sources external to the body, a deep dose equivalent in excess of 1 millisievert (0.1 rem, or 100 millirem), a lens dose equivalent in excess of 1.5 millisievert (0.15 rem, or 150 millirem), or a shallow dose equivalent to the skin or to the extremities in excess of 5 millisievert (0.5 rem, or 500 millirem);

17.1.1.3 Declared pregnant women likely to receive during the entire pregnancy, from radiation sources external to the body, a deep dose equivalent in excess of 1 millisievert (0.1 rem, or 100 millirem);

17.1.1.4 Individuals entering a high or very high radiation area; and

17.1.1.5 Individuals working with medical fluoroscopic equipment.

17.1.1.5.1 An individual monitoring device used for the dose to an embryo/fetus of a declared pregnant woman, pursuant to subsection 12.1, shall be located under the protective apron at the waist.

17.1.1.5.2 An individual monitoring device used for lense dose equivalent shall be for external radiation pursuant to subsection 6.3.2, it shall be located at the neck (collar) outside the protective apron. When a second individual monitoring device is used for the same purpose, it shall be located under the protective apron at the waist. The second individual monitoring device is required for a declared pregnant woman.

17.1.2 Each licensee or registrant shall monitor, to determine compliance with Section 9.0, the occupational intake of radioactive material by and assess the committed effective dose equivalent to:

17.1.2.1 Adults likely to receive, in 1 year, an intake in excess of 10% of the applicable ALI in Table I, Columns 1 and 2, of Appendix B;

17.1.2.2 Minors likely to receive, in 1 year, a committed effective dose equivalent in excess of 0.1 millisievert (0.01 rem, or 100 millirem); and

17.1.2.3 Declared pregnant women likely to receive, during the entire pregnancy, a committed dose equivalent in excess of 1 millisievert (0.1 rem, or 100 millirem).

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-18.0** Location of Individual Monitoring Devices {#sec-4465-18.0 omnilex-key=us-de-regs-official--title-16--4465-18.0}

18.1 Each licensee or registrant shall ensure that individuals who are required to monitor occupational doses in accordance with subsection 17.1.1 wear individual monitoring devices as follows:

18.1.1 An individual monitoring device used for monitoring the dose to the whole body shall be worn at the unshielded location of the whole body likely to receive the highest exposure. When a protective apron is worn, the location of the individual monitoring device is typically at the neck (collar);

18.1.2 An individual monitoring device used for monitoring the dose to an embryo/fetus of a declared pregnant woman, pursuant to subsection 12.1, shall be located at the waist under any protective apron being worn by the woman;

18.1.3 An individual monitoring device used for monitoring the lens dose equivalent, to demonstrate compliance with subsection 6.1.2.1, shall be located at the neck (collar), outside any protective apron being worn by the monitored individual, or at an unshielded location closer to the eye;

18.1.4 An individual monitoring device used for monitoring the dose to the extremities, to demonstrate compliance with subsection 6.1.2.2, shall be worn on the extremity likely to receive the highest exposure. Each individual monitoring device shall be oriented to measure the highest dose to the extremity being monitored.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-19.0** Control of Access to High Radiation Areas {#sec-4465-19.0 omnilex-key=us-de-regs-official--title-16--4465-19.0}

19.1 The licensee or registrant shall ensure that each entrance or access point to a high radiation area has 1 or more of the following features:

19.1.1 A control device that, upon entry into the area, causes the level of radiation to be reduced below that level at which an individual might receive a deep dose equivalent of 1 millisievert (0.1 rem, or 100 millirem) in 1 hour at 30 centimeters from the source of radiation or from any surface that the radiation penetrates;

19.1.2 A control device that energizes a conspicuous visible or audible alarm signal so that the individual entering the high radiation area and the supervisor of the activity are made aware of the entry; or

19.1.3 Entryways that are locked, except during periods when access to the areas is required, with control over each individual entry.

19.2 In place of the controls required by subsection 19.1 for a high radiation area, the licensee or registrant may substitute continuous direct or electronic surveillance that is capable of preventing unauthorized entry.

19.3 The licensee or registrant may apply to the Agency for approval of alternative methods for controlling access to high radiation areas.

19.4 The licensee or registrant shall establish the controls required by subsections 19.1 and 19.3 in a way that does not prevent individuals from leaving a high radiation area.

19.5 The licensee or registrant is not required to control entrance or access to rooms or other areas in hospitals solely because of the presence of patients containing radioactive material, provided that there are personnel in attendance who are taking the necessary precautions to prevent the exposure of individuals to radiation or radioactive material in excess of the established limits in Part D and to operate within the ALARA provisions of the licensee's or registrant's radiation protection program.

19.6 The registrant is not required to control entrance or access to rooms or other areas containing sources of radiation capable of producing a high radiation area as described in Section 19.0 if the registrant has met all the specific requirements for access and control specified in other applicable Parts of these regulations, such as, Part E for industrial radiography, Part F for X-rays in the healing arts, and Part I for particle accelerators.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-20.0** Control of Access to Very High Radiation Areas {#sec-4465-20.0 omnilex-key=us-de-regs-official--title-16--4465-20.0}

20.1 In addition to the requirements in Section 19.0, the licensee or registrant shall institute measures to ensure that an individual is not able to gain unauthorized or inadvertent access to areas in which radiation levels could be encountered at 5 gray (500 rad) or more in 1 hour at 1 meter from a source of radiation or any surface through which the radiation penetrates. This requirement does not apply to rooms or areas in which diagnostic X-ray systems are the only source of radiation, or to non-self-shielded irradiators.

20.2 The registrant is not required to control entrance or access to rooms or other areas containing sources of radiation capable of producing a very high radiation area as described in subsection 20.1. if the registrant has met all the specific requirements for access and control specified in other applicable Parts of these regulations, such as, Part E for industrial radiography, Part F for X-rays in the healing arts, and Part I for particle accelerators.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-21.0** Control of Access to Very High Radiation Areas – Irradiators {#sec-4465-21.0 omnilex-key=us-de-regs-official--title-16--4465-21.0}

21.1 Section 21.0 applies to licensees or registrants with sources of radiation in non-self-shielded irradiators. Section 21.0 does not apply to sources of radiation that are used in teletherapy, in industrial radiography, or in completely self-shielded irradiators in which the source of radiation is both stored and operated within the same shielding radiation barrier and, in the designed configuration of the irradiator, is always physically inaccessible to any individual and cannot create high levels of radiation in an area that is accessible to any individual.

21.2 Each area in which there may exist radiation levels in excess of 5 gray (500 rad) in 1 hour at 1 meter from a source of radiation that is used to irradiate materials shall meet the following requirements:

21.2.1 Each entrance or access point shall be equipped with entry control devices which:

21.2.1.1 Function automatically to prevent any individual from inadvertently entering a very high radiation area;

21.2.1.2 Permit deliberate entry into the area only after a control device is actuated that causes the radiation level within the area, from the source of radiation, to be reduced below that at which it would be possible for an individual to receive a deep dose equivalent in excess of 1 millisievert (0.1 rem, or 100 millirem) in 1 hour; and

21.2.1.3 Prevent operation of the source of radiation if it would produce radiation levels in the area that could result in a deep dose equivalent to an individual in excess of 1 millisievert (0.1 rem, or 100 millirem) in 1 hour.

21.2.2 Additional control devices shall be provided so that, upon failure of the entry control devices to function as required by subsection 21.2.1:

21.2.2.1 The radiation level within the area, from the source of radiation, is reduced below that at which it would be possible for an individual to receive a deep dose equivalent in excess of 1 millisievert (0.1 rem, or 100 millirem) in 1 hour; and

21.2.2.2 Conspicuous visible and audible alarm signals are generated to make an individual attempting to enter the area aware of the hazard and at least 1 other authorized individual, who is physically present, familiar with the activity, and prepared to render or summon assistance, aware of the failure of the entry control devices.

21.2.3 The licensee or registrant shall provide control devices so that, upon failure or removal of physical radiation barriers other than the sealed source's shielded storage container:

21.2.3.1 The radiation level from the source of radiation is reduced below that at which it would be possible for an individual to receive a deep dose equivalent in excess of 1 millisievert (0.1 rem, or 100 millirem) in 1 hour; and

21.2.3.2 Conspicuous visible and audible alarm signals are generated to make potentially affected individuals aware of the hazard and the licensee or registrant or at least one other individual, who is familiar with the activity and prepared to render or summon assistance, aware of the failure or removal of the physical barrier.

21.2.4 When the shield for stored sealed sources is a liquid, the licensee or registrant shall provide means to monitor the integrity of the shield and to signal, automatically, loss of adequate shielding.

21.2.5 Physical radiation barriers that comprise permanent structural components, such as walls, that have no credible probability of failure or removal in ordinary circumstances need not meet the requirements of subsections 21.2.3 and 21.2.4.

21.2.6 Each area shall be equipped with devices that will automatically generate conspicuous visible and audible alarm signals to alert personnel in the area before the source of radiation can be put into operation and in time for any individual in the area to operate a clearly identified control device, which must be installed in the area and which can prevent the source of radiation from being put into operation.

21.2.7 Each area shall be controlled by use of such administrative procedures and such devices as are necessary to ensure that the area is cleared of personnel prior to each use of the source of radiation.

21.2.8 Each area shall be checked by a radiation measurement to ensure that, prior to the first individual's entry into the area after any use of the source of radiation, the radiation level from the source of radiation in the area is below that at which it would be possible for an individual to receive a deep dose equivalent in excess of 1 millisievert (0.1 rem or 100 millirem) in 1 hour.

21.2.9 The entry control devices required in subsection 21.2.1 shall be tested for proper functioning. See Section 42.0 for recordkeeping requirements.

21.2.9.1 Testing shall be conducted prior to initial operation with the source of radiation on any day, unless operations were continued uninterrupted from the previous day;

21.2.9.2 Testing shall be conducted prior to resumption of operation of the source of radiation after any unintentional interruption; and

21.2.9.3 The licensee or registrant shall submit and adhere to a schedule for periodic tests of the entry control and warning systems.

21.2.10 The licensee or registrant shall not conduct operations, other than those necessary to place the source of radiation in safe condition or to effect repairs on controls, unless control devices are functioning properly.

21.2.11 Entry and exit portals that are used in transporting materials to and from the irradiation area, and that are not intended for use by individuals, shall be controlled by such devices and administrative procedures as are necessary to physically protect and warn against inadvertent entry by any individual through these portals. Exit portals for irradiated materials shall be equipped to detect and signal the presence of any loose radioactive material that is carried toward such an exit and automatically to prevent loose radioactive material from being carried out of the area.

21.3 Licensees, registrants, or applicants for licenses or registrations for sources of radiation within the purview of subsection 21.2 which will be used in a variety of positions or in locations, such as open fields or forests, that make it impracticable to comply with certain requirements of subsection 21.2, such as those for the automatic control of radiation levels, may apply to the Agency for approval of alternative safety measures. Alternative safety measures shall provide personnel protection at least equivalent to those specified in subsection 21.2. At least one of the alternative measures shall include an entry-preventing interlock control based on a measurement of the radiation that ensures the absence of high radiation levels before an individual can gain access to the area where such sources of radiation are used.

21.4 The entry control devices required by subsections 21.2 and 21.3 shall be established in such a way that no individual will be prevented from leaving the area.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-22.0** Use of Process or Other Engineering Controls to Limit Exposure {#sec-4465-22.0 omnilex-key=us-de-regs-official--title-16--4465-22.0}

The licensee or registrant shall use, to the extent practical, process or other engineering controls, such as, containment, decontamination or ventilation, to control the concentrations of radioactive material in air.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-23.0** Use of Other Controls {#sec-4465-23.0 omnilex-key=us-de-regs-official--title-16--4465-23.0}

23.1 When it is not practicable to apply process or other engineering controls to control the concentrations of radioactive material in air to values below those that define an airborne radioactivity area, the licensee or registrant shall, consistent with maintaining the total effective dose equivalent ALARA, increase monitoring and limit intakes by one or more of the following means:

23.1.1 Control of access;

23.1.2 Limitation of exposure times;

23.1.3 Use of respiratory protection equipment; or

23.1.4 Other controls.

23.2 If the licensee performs an ALARA analysis to determine whether or not respirators should be used, the licensee may also consider the impact of respirator use on workers' industrial health and safety.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-24.0** Use of Individual Respiratory Protection Equipment to control exposure {#sec-4465-24.0 omnilex-key=us-de-regs-official--title-16--4465-24.0}

24.1 If the licensee or registrant uses respiratory protection equipment to limit intakes pursuant to Section 23.0:

24.1.1 Except as provided in subsection 24.1.2, the licensee or registrant shall use only respiratory protection equipment that is tested and certified by the National Institute for Occupational Safety and Health;

24.1.2 If the licensee or registrant wishes to use equipment that has not been tested or certified by the National Institute for Occupational Safety and Health, or for which there is no schedule for testing or certification, the licensee shall submit an application to the Agency for authorized use of this equipment, except as otherwise noted in this Part. The application must include evidence that the material and performance characteristics of the equipment are capable of providing the proposed degree of protection under anticipated conditions of use. This must be demonstrated either by the licensee's or registrant's testing or on the basis of reliable test information;

24.1.3 The licensee or registrant shall implement and maintain a respiratory protection program that includes:

24.1.3.1 Air sampling sufficient to identify the potential hazard, permit proper equipment selection, and estimate doses;

24.1.3.2 Surveys and bioassays, as necessary, to evaluate actual intakes;

24.1.3.3 Testing of respirators for operability (user seal check for face sealing devices and functional check for others) immediately prior to each use; and

24.1.3.4 Written procedures regarding:

24.1.3.4.1 Monitoring, including air sampling and bioassays;

24.1.3.4.2 Supervision and training or respirator users;

24.1.3.4.3 Fit testing;

24.1.3.4.4 Respirator selection;

24.1.3.4.5 Breathing air quality;

24.1.3.4.6 Inventory and control;

24.1.3.4.7 Storage, issuance, maintenance, repair, testing, and quality assurance of respiratory protection equipment;

24.1.3.4.8 Recordkeeping; and

24.1.3.4.9 Limitations on periods of respirator use and relief from respirator use.

24.1.3.5 Determination by a physician that the individual user is medically fit to use the respiratory protection equipment before:

24.1.3.5.1 The initial fitting of a face sealing respirator;

24.1.3.5.2 Before the first field use of non- face sealing respirators; and

24.1.3.5.3 Either every 12 months thereafter, or periodically at a frequency determined by a physician.

24.1.3.6 Fit testing, with a fit factor 10 times the APF for negative pressure devices, and a fit factor 500 for any positive pressure, continuous flow, and pressure-demand devices, before the first field use of tight fitting, face sealing respirators and periodically thereafter at a frequency not to exceed 1 year. Fit testing must be performed with the facepiece operating in the negative pressure mode.

24.1.4 The licensee or registrant shall advise each respirator user that the user may leave the area at any time for relief from respirator use in the event of equipment malfunction, physical or psychological distress, procedural or communication failure, significant deterioration of operating conditions, or any other conditions that might require such relief.

24.1.5 The licensee or registrant shall also consider limitations appropriate to the type and mode of use. When selecting respiratory devices the licensee or registrant shall provide for vision correction, adequate communication, low temperature work environments and the concurrent use of other safety or radiological protection equipment. The licensee or registrant shall use equipment in such a way as not to interfere with the proper operation of the respirator.

24.1.6 Standby rescue persons are required whenever one-piece atmosphere-supplying suits, or any combination of supplied air respiratory protection device and personnel protective equipment are used from which an unaided individual would have difficulty extricating himself or herself. The standby persons must be equipped with respiratory protection devices or other apparatus appropriate for the potential hazards. The standby rescue persons shall observe or otherwise maintain continuous communication with the workers (visual, voice, signal line, telephone, radio, or other suitable means), and be immediately available to assist them in case of a failure of the air supply or for any other reason that requires relief from distress. A sufficient number of standby rescue persons must be immediately available to assist all users of this type of equipment and to provide effective emergency rescue if needed.

24.1.7 Atmosphere-supplying respirators must be supplied with respirable air of grade D quality or better as defined by the Compressed Gas Association in publication G-7.1, "Commodity Specification for Air," 1997 and included in the regulations of the Occupational Safety and Health Administration (29 CFR 1910.134(i)(1)(ii)(A) through (E). Grade D quality air criteria include:

24.1.7.1 Oxygen content (v/v) of 19.5-23.5%;

24.1.7.2 Hydrocarbon (condensed) content of 5 milligrams per cubic meter of air or less;

24.1.7.3 Carbon Monoxide (CO) content of 10 ppm or less;

24.1.7.4 Carbon Dioxide content of 1,000 ppm or less; and

24.1.7.5 Lack of noticeable odor.

24.1.8 The licensee shall ensure that no objects, materials or substances, such as facial hair, or any conditions that interfere with the face-facepiece seal or valve function, and that are under the control of the wearer, are present between the skin of the wearer’s face and the sealing surface of a tight-fitting respirator facepiece.

24.1.9 In estimating the dose to individuals from intake of airborne radioactive materials, the concentration of radioactive material in the air that is inhaled when respirators are worn is initially assumed to be the ambient concentration in air without the respiratory protection, divided by the assigned protection factor. If the dose is later found to be greater than the estimated dose, the corrected value must be used. If the dose is later found to be less than the estimated dose, the corrected value may be used.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-25.0** Further Restrictions on the Use of Respiratory Protection Equipment {#sec-4465-25.0 omnilex-key=us-de-regs-official--title-16--4465-25.0}

25.1 The Agency may impose restrictions in addition to the provisions of Sections 23.0 and 24.0, and Appendix A of this Part, in order to:

25.1.1 Ensure that the respiratory protection program of the licensee is adequate to limit doses to individuals from intakes of radioactive materials consistent with maintaining total effective dose equivalent ALARA; and

25.1.2 Limit the extent to which a licensee may use respiratory protection equipment instead of process or other engineering controls.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-26.0** Application for use of Higher Assigned Protection Factors {#sec-4465-26.0 omnilex-key=us-de-regs-official--title-16--4465-26.0}

26.1 The licensee or registrant shall obtain authorization from the Agency before using assigned respiratory protection factors in excess of those specified in Appendix A. The Agency may authorize a licensee or registrant to use higher protection factors on receipt of an application that:

26.1.1 Describes the situation for which a need exists for higher protection factors; and

26.1.2 Demonstrates that the respiratory protection equipment provides these higher protection factors under the proposed conditions of use.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-27.0** Security and Control of Licensed or Registered Sources of Radiation {#sec-4465-27.0 omnilex-key=us-de-regs-official--title-16--4465-27.0}

27.1 The licensee or registrant shall secure licensed or registered radioactive material from unauthorized removal or access.

27.2 The licensee or registrant shall maintain constant surveillance, and use engineering controls or devices, or administrative procedures to prevent unauthorized use of licensed or registered radioactive material that is in an unrestricted area and that is not in storage.

27.3 The registrant shall secure registered radiation machines from unauthorized removal.

27.4 The registrant shall use devices or administrative procedures to prevent unauthorized use of registered radiation machines.

Precautionary Procedures

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-28.0** Caution Signs {#sec-4465-28.0 omnilex-key=us-de-regs-official--title-16--4465-28.0}

28.1 Standard Radiation Symbol. Unless otherwise authorized by the Agency, the symbol prescribed by this section shall use the colors magenta, or purple, or black on yellow background. The symbol prescribed is the 3-bladed design as follows:

Figure 1. Radiation Symbol.

1. Cross-hatched area is to be magenta, or purple, or black, and

2. The background is to be yellow.

28.2 Exception to Color Requirements for Standard Radiation Symbol. Notwithstanding the requirements of subsection 28.1, licensees or registrants are authorized to label sources, source holders, or device components containing sources of radiation that are subjected to high temperatures, with conspicuously etched or stamped radiation caution symbols and without a color requirement.

28.3 Additional Information on Signs and Labels. In addition to the contents of signs and labels prescribed in Part D, the licensee or registrant may provide, on or near the required signs and labels, additional information, as appropriate, to make individuals aware of potential radiation exposures and to minimize the exposures.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-29.0** Posting Requirements {#sec-4465-29.0 omnilex-key=us-de-regs-official--title-16--4465-29.0}

29.1 Posting of Radiation Areas. The licensee or registrant shall post each radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, RADIATION AREA."

29.2 Posting of High Radiation Areas. The licensee or registrant shall post each high radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, HIGH RADIATION AREA" or "DANGER, HIGH RADIATION AREA."

29.3 Posting of Very High Radiation Areas. The licensee or registrant shall post each very high radiation area with a conspicuous sign or signs bearing the radiation symbol and words " DANGER, VERY HIGH RADIATION AREA."

29.4 Posting of Airborne Radioactivity Areas. The licensee or registrant shall post each airborne radioactivity area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, AIRBORNE RADIOACTIVITY AREA" or "DANGER, AIRBORNE RADIOACTIVITY AREA."

29.5 Posting of Areas or Rooms in which Licensed or Registered Material is Used or Stored. The licensee or registrant shall post each area or room in which there is used or stored an amount of licensed or registered material exceeding 10 times the quantity of such material specified in Appendix C with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL(S)" or "DANGER, RADIOACTIVE MATERIAL(S)."

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-30.0** Exceptions to Posting Requirements {#sec-4465-30.0 omnilex-key=us-de-regs-official--title-16--4465-30.0}

30.1 A licensee or registrant is not required to post caution signs in areas or rooms containing sources of radiation for periods of less than 8 hours, if each of the following conditions is met:

30.1.1 The sources of radiation are constantly attended during these periods by an individual who takes the precautions necessary to prevent the exposure of individuals to sources of radiation in excess of the limits established in Part D; and

30.1.2 The area or room is subject to the licensee’s or registrant’s control.

30.2 A room or area is not required to be posted with a caution sign because of the presence of a sealed source provided the radiation level at 30 centimeters from the surface of the sealed source container or housing does not exceed 0.05 millisievert (0.005 rem or 5 millirem) per hour.

30.3 A room or area is not required to be posted with a caution sign because of the presence of radiation machines used solely for diagnosis in the healing arts.

30.4 Rooms in hospitals or clinics that are used for teletherapy are exempt from the requirement to post caution signs under Section 29.0 if:

30.4.1 Access to the room is controlled pursuant to the providers ALARA license conditions; and

30.4.2 Personnel in attendance take necessary precautions to prevent the inadvertent exposure of workers, other patients, and members of the public to radiation in excess of the limits established in this Part.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-31.0** Labeling of Radiation Machines {#sec-4465-31.0 omnilex-key=us-de-regs-official--title-16--4465-31.0}

Each registrant shall ensure that each radiation machine is labeled in a conspicuous manner which cautions individuals that radiation is produced when it is energized.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-32.0** Exemptions to Labeling Requirements for Radiation Machines {#sec-4465-32.0 omnilex-key=us-de-regs-official--title-16--4465-32.0}

A licensee or registrant is not required to label radiation machines if the area or room is subject to the licensee’s or registrant’s control and precautions are taken to prevent the exposure of individuals to sources of radiation in excess of the limits established in Part D.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-33.0** General Requirements for Waste Disposal {#sec-4465-33.0 omnilex-key=us-de-regs-official--title-16--4465-33.0}

Compliance with Environmental and Health Protection Regulations. Nothing in these regulations relieves the licensee or registrant from complying with other applicable Federal, State and local regulations governing any other toxic or hazardous properties of materials disposed of by the licensee or registrant.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-34.0** General Provisions for Records {#sec-4465-34.0 omnilex-key=us-de-regs-official--title-16--4465-34.0}

34.1 Each licensee or registrant shall use the Standard Internationale (SI) units becquerel, gray, sievert and coulomb per kilogram, or the special units curie, rad, rem and roentgen, including multiples and subdivisions, and shall clearly indicate the units of all quantities on records required by Part D.

34.2 The licensee or registrant shall make a clear distinction among the quantities entered on the records required by Part D, such as, total effective dose equivalent shallow dose equivalent, lens dose equivalent, deep dose equivalent, or committed effective dose equivalent.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-35.0** Records of Radiation Protection Programs {#sec-4465-35.0 omnilex-key=us-de-regs-official--title-16--4465-35.0}

35.1 Each licensee or registrant shall maintain records of the radiation protection program, including:

35.1.1 The provisions of the program; and

35.1.2 Audits and other reviews of program content and implementation.

35.2 The licensee or registrant shall retain the records required by subsection 35.1.1 until the Agency terminates each pertinent license or registration requiring the record. The licensee or registrant shall retain the records required by subsection 35.1.2 for 3 years after the record is made.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-36.0** Records of Surveys {#sec-4465-36.0 omnilex-key=us-de-regs-official--title-16--4465-36.0}

36.1 Each licensee or registrant shall maintain records showing the results of surveys and calibrations required by Section 16.0. The licensee or registrant shall retain these records for 3 years after the record is made.

36.2 The licensee or registrant shall retain each of the following records until the Agency terminates each pertinent license or registration requiring the record:

36.2.1 Records of the results of surveys to determine the dose from external sources of radiation used, in the absence of or in combination with individual monitoring data, in the assessment of individual dose equivalents;

36.2.2 Records of the results of measurements and calculations used to determine individual intakes of radioactive material and used in the assessment of internal dose;

36.2.3 Records showing the results of air sampling, surveys, and bioassays required pursuant to subsections 24.1.3.1 and 24.1.3.2; and

36.2.4 Records of the results of measurements and calculations used to evaluate the release of radioactive effluents to the environment.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-37.0** Determination and Records of Prior Occupational Dose {#sec-4465-37.0 omnilex-key=us-de-regs-official--title-16--4465-37.0}

37.1 For each individual who is likely to receive, in a year, an occupational dose requiring monitoring pursuant to Section 17.0, the licensee or registrant shall:

37.1.1 Determine the occupational radiation dose received during the current year; and

37.1.2 Attempt to obtain the records of cumulative occupational radiation dose.

37.2 Prior to permitting an individual to participate in a planned special exposure, the licensee or registrant shall determine:

37.2.1 The internal and external doses from all previous planned special exposures; and

37.2.2 All doses in excess of the limits, including doses received during accidents and emergencies, received during the lifetime of the individual; and

37.3 In complying with the requirements of subsection 37.1, a licensee or registrant may:

37.3.1 Accept, as a record of the occupational dose that the individual received during the current year, a written signed statement from the individual, or from the individual's most recent employer for work involving radiation exposure, that discloses the nature and the amount of any occupational dose that the individual received during the current year; and

37.3.2 Accept, as the record of cumulative radiation dose, an up-to-date Agency Form Y (Part J, Appendix B) or equivalent, signed by the individual and countersigned by an appropriate official of the most recent employer for work involving radiation exposure, or the individual's current employer, if the individual is not employed by the licensee or registrant; and.

37.3.3 Obtain reports of the individual's dose equivalent(s) from the most recent employer for work involving radiation exposure, or the individual's current employer, if the individual is not employed by the licensee or registrant, by telephone, email, facsimile, other electronic media or letter. The licensee or registrant shall request a written verification of the dose data if the authenticity of the transmitted report cannot be established.

37.4 The licensee or registrant shall record the exposure history, as required by subsection 37.1, on Agency Form Y, (Part J, Appendix B) or other clear and legible record, of all the information required on that form.

37.4.1 The form or record shall show each period in which the individual received occupational exposure to radiation or radioactive material and shall be signed by the individual who received the exposure. For each period for which the licensee or registrant obtains reports, the licensee or registrant shall use the dose shown in the report in preparing Agency form Y (Part J, Appendix B) or equivalent. For any period in which the licensee or registrant does not obtain a report, the licensee or registrant shall place a notation on Agency Form Y or equivalent indicating the periods of time for which data are not available.

37.4.2 For the purposes of complying with this requirement, licensees or registrants are not required to partition historical dose between external dose equivalent(s) and internal committed dose equivalent(s). Further, occupational exposure histories obtained and recorded on Agency Form Y (Part J, Appendix B) or equivalent before July 10, 2002, would not have included effective dose equivalent, but may be used in the absence of specific information on the intake of radionuclides by the individual.

37.5 If the licensee or registrant is unable to obtain a complete record of an individual's current and previously accumulated occupational dose, the licensee or registrant shall assume:

37.5.1 In establishing administrative controls pursuant to subsection 6.6 for the current year, that the allowable dose limit for the individual is reduced by 12.5 millisievert (1.25 rem, or 1250 millirem) for each quarter for which records were unavailable and the individual was engaged in activities that could have resulted in occupational radiation exposure; and

37.5.2 That the individual is not available for planned special exposures.

37.6 The licensee or registrant shall retain the records on Agency Form Y (Part J, Appendix B) or equivalent until the Agency terminates each pertinent license or registration requiring this record. The licensee or registrant shall retain records used in preparing Agency Form Y (Part J, Appendix B) or equivalent for 3 years after the record is made.

37.7 Upon termination of the license or registration, the licensee or registrant shall permanently store records on Agency Form Y (Part J, Appendix B) or equivalent, or shall make provision with the Agency for transfer to the Agency.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-38.0** Records of Planned Special Exposures {#sec-4465-38.0 omnilex-key=us-de-regs-official--title-16--4465-38.0}

38.1 For each use of the provisions of Section 10.0 for planned special exposures, the licensee or registrant shall maintain records that describe:

38.1.1 The exceptional circumstances requiring the use of a planned special exposure;

38.1.2 The name of the management official who authorized the planned special exposure and a copy of the signed authorization;

38.1.3 What actions were necessary;

38.1.4 Why the actions were necessary;

38.1.5 What precautions were taken to assure that doses were maintained ALARA;

38.1.6 What individual and collective doses were expected to result; and

38.1.7 The doses actually received in the planned special exposure.

38.2 The licensee or registrant shall retain the records until the Agency terminates each pertinent license or registration requiring these records.

38.3 Upon termination of the license or registration, the licensee or registrant shall permanently store records on Agency Form Y (Part J, Appendix B) or equivalent, or shall make provision with the Agency for transfer to the Agency.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-39.0** Records of Individual Monitoring Results {#sec-4465-39.0 omnilex-key=us-de-regs-official--title-16--4465-39.0}

39.1 Recordkeeping Requirement. Each licensee or registrant shall maintain records of doses received by all individuals for whom monitoring was required pursuant to Section 17.0, and records of doses received during planned special exposures, accidents, and emergency conditions. Assessments of dose equivalent and records made using units in effect before need not be changed. These records shall include, when applicable:

39.1.1 The deep dose equivalent to the whole body, lens dose equivalent, shallow dose equivalent to the skin, and shallow dose equivalent to the extremities;

39.1.2 The estimated intake of radionuclides, see Section 7.0;

39.1.3 The committed effective dose equivalent assigned to the intake of radionuclides;

39.1.4 The specific information used to calculate the committed effective dose equivalent pursuant to subsections 9.1 and 9.3 and when required by Section 17.0;

39.1.5 The total effective dose equivalent when required by Section 7.0; and

39.1.6 The total of the deep dose equivalent and the committed dose to the organ receiving the highest total dose.

39.2 Recordkeeping Frequency. The licensee or registrant shall make entries of the records specified in subsection 39.1 at intervals not to exceed 1 year.

39.3 Recordkeeping Format. The licensee or registrant shall maintain the records specified in subsection 39.1 on Agency Form Z (Part J, Appendix C), in accordance with the instructions for Agency Form Z (Part J, Appendix C), or in clear and legible records containing all the information required by Agency Form Z (Part J, Appendix C).

39.4 The licensee or registrant shall maintain the records of dose to an embryo/fetus with the records of dose to the declared pregnant woman. The declaration of pregnancy, including the estimated date of conception, shall also be kept on file, but must be maintained as confidential records, accessible only to the registrant or licensee radiation safety officer, the declared pregnant woman, and medical personnel authorized to access her confidential health records.

39.5 The licensee or registrant shall retain each required form or record until the Agency terminates each pertinent license or registration requiring the record.

39.6 Upon termination of the license or registration, the licensee or registrant shall permanently store records on Agency Form Y (Part J, Appendix B) or equivalent, or shall make provision with the Agency for transfer to the Agency.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-40.0** Records of Dose to Individual Members of the Public {#sec-4465-40.0 omnilex-key=us-de-regs-official--title-16--4465-40.0}

40.1 Each licensee or registrant shall maintain records sufficient to demonstrate compliance with the dose limit for individual members of the public. See Section 13.0.

40.2 The licensee or registrant shall retain the records required by subsection 40.1 until the Agency terminates each pertinent license or registration requiring the record.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-41.0** Records of Waste Disposal {#sec-4465-41.0 omnilex-key=us-de-regs-official--title-16--4465-41.0}

Compliance with Environmental and Health Protection Regulations. Nothing in these regulations relieves the licensee or registrant from complying with other applicable Federal, State and local regulations governing any other toxic or hazardous properties of materials that may be disposed of by the licensee or registrant.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-42.0** Records of Testing Entry Control Devices for Very High Radiation Areas {#sec-4465-42.0 omnilex-key=us-de-regs-official--title-16--4465-42.0}

42.1 Each licensee or registrant shall maintain records of tests made pursuant to subsection 21.2.9 on entry control devices for very high radiation areas. These records must include the date, time, and results of each such test of function.

42.2 The licensee or registrant shall retain the records required by subsection 42.1 for 3 years after the record is made.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-43.0** Form of Records {#sec-4465-43.0 omnilex-key=us-de-regs-official--title-16--4465-43.0}

Each record required by Part D shall be legible throughout the specified retention period. The record shall be the original or a reproduced copy or a microform, provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period or the record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records, such as letters, drawings, and specifications, shall include all pertinent information, such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-44.0** Records of Tests for Leakage or Contamination of Sealed Sources {#sec-4465-44.0 omnilex-key=us-de-regs-official--title-16--4465-44.0}

Records of tests for leakage or contamination of sealed sources required by Section 15.0 shall be kept on file in accordance with the facility radioactive material license.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-45.0** Reports of Stolen, Lost, or Missing Licensed or Registered Sources of Radiation {#sec-4465-45.0 omnilex-key=us-de-regs-official--title-16--4465-45.0}

45.1 Telephone Reports. Each licensee or registrant shall report to the Agency by telephone immediately after its occurrence becomes known to the registrant, any stolen, lost, or missing radiation machine.

45.2 Written Reports. Each licensee or registrant required to make a report pursuant to subsection 45.1 shall, within 30 days after making the telephone report, make a written report to the Agency setting forth the following information:

45.2.1 A description of the licensed or registered source of radiation involved, including, for radiation machines, the manufacturer, model and serial number, type and maximum energy of radiation emitted;

45.2.2 A description of the circumstances under which the loss or theft occurred;

45.2.3 A statement of disposition, or probable disposition, of the registered source of radiation involved;

45.2.4 Exposures of individuals to radiation, and circumstances under which the exposures occurred;

45.2.5 Actions that have been taken, or will be taken, to recover the source of radiation; and

45.2.6 Procedures or measures that have been, or will be, adopted to ensure against a recurrence of the loss or theft of licensed or registered sources of radiation.

45.3 Subsequent to filing the written report, the licensee or registrant shall also report additional substantive information on the loss or theft within 30 days after the licensee or registrant learns of such information.

45.4 The licensee or registrant shall prepare any report filed with the Agency pursuant to this section so that names of individuals who may have received exposure to radiation are stated in a separate and detachable portion of the report.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-46.0** Notification of Incidents {#sec-4465-46.0 omnilex-key=us-de-regs-official--title-16--4465-46.0}

46.1 Immediate Notification. Notwithstanding other requirements for notification, each licensee or registrant shall immediately report each event involving a source of radiation possessed by the licensee or registrant that may have caused or threatens to cause any of the following conditions:

46.1.1 An individual to receive:

46.1.1.1 A total effective dose equivalent of 0.25 sievert (25 rem, or 25,000 millirem) or more;

46.1.1.2 A lense dose equivalent of 0.75 sievert (75 rem, or 75,000 millirem) or more; or

46.1.1.3 A shallow dose equivalent to the skin or extremities or a total organ dose equivalent of 2.5 gray (250 rad) or more; or

46.1.2 The release of radioactive material, inside or outside of a restricted area, so that, had an individual been present for 24 hours, the individual could have received an intake 5 times the occupational ALI. This provision does not apply to locations where personnel are not normally stationed during routine operations, such as hot-cells or process enclosures.

46.2 Twenty-Four Hour Notification. Each licensee or registrant shall, within 24 hours of discovery of the event, report to the Agency each event involving loss of control of a licensed or registered source of radiation possessed by the licensee or registrant that may have caused, or threatens to cause, any of the following conditions:

46.2.1 An individual to receive, in a period of 24 hours:

46.2.1.1 A total effective dose equivalent exceeding 0.05 sievert (5 rem, or 5000 millirem);

46.2.1.2 A lense dose equivalent exceeding 0.15 sievert (15 rem, or 15,000 millirem);

46.2.1.3 A shallow dose equivalent to the skin or extremities or a total organ dose equivalent exceeding 0.5 sievert (50 rem, or 50,000 millirem); or

46.2.2 The release of radioactive material, inside or outside of a restricted area, so that, had an individual been present for 24 hours, the individual could have received an intake in excess of one occupational ALI. This provision does not apply to locations where personnel are not normally stationed during routine operations, such as hot-cells or process enclosures.

46.3 Licensees or registrants shall make the reports required by subsections 46.1 and 46.2 by initial contact by telephone to the Agency and shall confirm the initial contact immediately by email, express mail or facsimile to the Agency. The Agency shall reply to the written notification within 24 hours to discuss timing of follow-up action by the Agency.

46.4 The licensee or registrant shall prepare each report filed with the Agency pursuant to Section 46.0 so that names of individuals who have received exposure to sources of radiation are stated in a separate and detachable portion of the report.

46.5 The provisions of Section 46.0 do not apply to doses that result from planned special exposures, provided such doses are within the limits for planned special exposures and are reported pursuant to Section 48.0.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-47.0** Reports of Exposures, Radiation Levels, and Concentrations of Radioactive Material Exceeding the Limits {#sec-4465-47.0 omnilex-key=us-de-regs-official--title-16--4465-47.0}

47.1 Reportable Events. In addition to the notification required by Section 46.0, each licensee or registrant shall submit a written report within 30 days after learning of any of the following occurrences:

47.1.1 Incidents for which notification is required by Section 46.0; or

47.1.2 Doses in excess of any of the following:

47.1.2.1 The occupational dose limits for adults in Section 6.0;

47.1.2.2 The occupational dose limits for a minor in Section 11.0;

47.1.2.3 The limits for an embryo/fetus of a declared pregnant woman in Section 12.0;

47.1.2.4 The limits for an individual member of the public in Section 13.0;

47.1.2.5 Any applicable limit in the license or registration; or

47.1.2.6 The ALARA constraints for air emissions established under subsection 5.4

47.1.3 Level of radiation or concentrations of radioactive material in:

47.1.3.1 A restricted area in excess of applicable limits in the license or registration; or

47.1.3.2 An unrestricted area in excess of 10 times the applicable limit set forth in Part D or in the license or registration, whether or not involving exposure of any individual in excess of the limits in Section 13.0; or

47.1.4 For licensees subject to the provisions of the Environmental Protection Agency's generally applicable environmental radiation standards in 40 CFR 190, levels of radiation or releases of radioactive material in excess of those standards, or of license conditions related to those standards.

47.2 Contents of Reports

47.2.1 Each report required by subsection 47.1 shall describe the extent of exposure of individuals to radiation and radioactive material, including, as appropriate:

47.2.1.1 Estimates of each individual's dose;

47.2.1.2 The levels of radiation and concentrations of radioactive material involved;

47.2.1.3 The cause of the elevated exposures, dose rates, or concentrations; and

47.2.1.4 Corrective steps taken or planned to ensure against a recurrence, including the schedule for achieving conformance with applicable limits, ALARA constraints generally applicable environmental standards, and associated license or registration conditions.

47.2.2 Each report filed pursuant to subsection 47.1 shall include for each occupationally overexposeda/ individual: the name, unique identification number such as employee or Social Security number, and date of birth. With respect to the limit for the embryo/fetus in Section 12.0, the identifiers should be those of the declared pregnant woman. The report shall be prepared so that this information is stated in a separate and detachable portion of the report.

47.3 All licensees or registrants who make reports pursuant to subsection 47.1 shall submit the report in writing to the Agency.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-48.0** Reports of Planned Special Exposures {#sec-4465-48.0 omnilex-key=us-de-regs-official--title-16--4465-48.0}

The licensee or registrant shall submit a written report to the Agency within 30 days following any planned special exposure conducted in accordance with Section 10.0, informing the Agency that a planned special exposure was conducted and indicating the date the planned special exposure occurred and the information required by Section 38.0.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-49.0** Reports to Individuals of Exceeding Dose Limits {#sec-4465-49.0 omnilex-key=us-de-regs-official--title-16--4465-49.0}

When a licensee or registrant is required, pursuant to Section 47.0 or 48.0 to report to the Agency any exposure of an identified occupationally exposed individual, or an identified member of the public, to radiation or radioactive material, the licensee shall also provide a copy of the report submitted to the Agency to the individual. This report must be transmitted at a time no later than the transmittal to the Agency.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-50.0** Notifications and Reports to Individuals {#sec-4465-50.0 omnilex-key=us-de-regs-official--title-16--4465-50.0}

50.1 Requirements for notification and reports to individuals of exposure to radiation or radioactive material are specified in Part J, Section 4.0 of this regulation.

50.2 When a licensee or registrant is required pursuant to Section 47.0 to report to the Agency any exposure of an individual to radiation or radioactive material, the licensee or registrant shall also notify the individual. Such notice shall be transmitted at a time not later than the transmittal to the Agency, and shall comply with the provisions of Part J, Subsection 4.1 of this regulation.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-51.0** Vacating Premises {#sec-4465-51.0 omnilex-key=us-de-regs-official--title-16--4465-51.0}

Each specific licensee or registrant in possession of a radiation source shall, no less than 30 days before vacating or relinquishing possession or control of premises, notify the Agency in writing of intent to vacate. When deemed necessary by the Agency, the licensee shall decontaminate the premises in such a manner as the Agency may specify.

A PDF version of Appendices A-F for Part D is available here:

https://regulations.delaware.gov/AdminCode/title16/Department of Health and Social Services/Division of Public Health/Health Systems Protection (HSP)/4465 PART D APPENDICES A-F.pdf

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-1.0** Purpose and Scope {#sec-4465-1.0 omnilex-key=us-de-regs-official--title-16--4465-1.0}

This Part establishes requirements, for which a registrant is responsible, for use of diagnostic and interventional X-ray equipment and imaging systems by, or under the supervision of, an individual authorized by and licensed in accordance with State statutes to practice medicine, dentistry, podiatry, chiropractic, osteopathy, or veterinary medicine. The provisions of this Part are in addition to, and not in substitution for, other applicable provisions of Parts A, B, D, G, H, J, K and X, of these regulations.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-2.0** Definitions {#sec-4465-2.0 omnilex-key=us-de-regs-official--title-16--4465-2.0}

As used in this Part, the following definitions apply:

"Accessible surface" means the external surface of the enclosure or housing of the radiation producing machine as provided by the manufacturer.

"Agency" means the Division of Public Health, Delaware Department of Health and Social Services

"Air kerma" means kerma in air (see definition of Kerma).

"Air kerma rate (AKR)" means the air kerma per unit time.

"Alert value" means a dose index (e.g., of CTDIvol (mGy) or DLP (mGy-cm)) that is set by the registrant to trigger an alert to the CT operator prior to scanning within an ongoing examination. The Alert value represents a universal dose index value well above the registrant established range for the examination that warrants more stringent review and consideration before proceeding.

"Aluminum equivalent" means the thickness of type 1100 aluminum alloy / affording the same attenuation, under specified conditions, as the material in question.

"Annual" means approximately every 12 months and not to exceed 14 months.

"Articulated joint" means a joint between 2 separate sections of a tabletop which provides the capacity of 1 of the sections to pivot on the line segment along which the sections join.

"Attenuation block" means a block or stack of type 1100 aluminum alloy, or aluminum alloy having equivalent attenuation, with dimensions 20 centimeters or larger by 20 centimeters or larger by 3.8 centimeters, that is large enough to intercept the entire X-ray beam.

"Automatic exposure control (AEC)" means a device which automatically controls 1 or more technique factors in order to obtain at a preselected location a required quantity of radiation.

"Automatic exposure rate control (AERC)" means a device which automatically controls 1 or more technique factors in order to obtain, at a preselected location, a required quantity of radiation per unit time.

"Barrier" (See "Protective barrier").

"Beam axis" means a line from the source through the centers of the X-ray fields.

"Beam-limiting device" means a device which provides a means to restrict the dimensions of the X-ray field.

"Bone densitometry" means a noninvasive measurement of certain physical characteristics of bone that reflect bone strength. Test results are typically reported as bone mineral content or density and are used for diagnosing osteoporosis, estimating fracture risk, and monitoring changes in bone mineral content.

"Bone densitometer" means a device intended for medical purposes to measure bone density and mineral content by X-ray or gamma ray transmission measurements through the bone and adjacent tissues. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

"C-arm fluoroscope" means a fluoroscopic X-ray system in which the image receptor and the X-ray tube housing assembly are connected or coordinated to maintain a spatial relationship. Such a system allows a change in the direction of the beam axis with respect to the patient without moving the patient.

"Cantilevered tabletop" means a tabletop designed such that the unsupported portion can be extended at least 100 centimeters beyond the support.

"Cassette holder" means a device, other than a spot-film device, that supports and/or fixes the position of the image receptor during a radiographic exposure.

"Coefficient of variation (C)" means the ratio of the standard deviation to the mean value of a population of observations. It is estimated using the following equation:

where:

s = Estimated standard deviation of the population.

x = Mean value of observations in sample;

xi = ith observation in sample;

n = Number of observations sampled.

"Computed radiography (CR; also see DR)" means a digital X-ray imaging method in which a photo-stimulable phosphor is used to capture and store a latent image. The latent image is read out by stimulating the phosphor with a laser. Computed radiography systems may use cassettes to house the phosphor, or it may be integrated into a digital radiography system.

"Computed tomography (CT)" means the production of a tomogram by the acquisition and computer processing of X-ray transmission data.

"Computed tomography dose index" (CTDI) means the average absorbed dose, along the z-axis, from a series of contiguous irradiations. It is measured from 1 axial CT scan (1 rotation of the X-ray tube), and is calculated by dividing the integrated absorbed dose by the nominal total beam collimation. The scattering media for CTDI consist of 2 (16 and 32 centimeters in diameter) polymethylmethacrylate (PMMA, e.g., acrylic or Lucite) cylinders of 14 centimeters length. The equation is:

Where:

D(z) = the radiation dose profile along the z-axis,

N = the number of tomographic sections imaged in a single axial scan. This is equal to the number of data channels used in a particular scan. The value of N may be less than or equal to the maximum number of data channels available on the system, and

T = the width of the tomographic section along the z-axis imaged by 1 data channel. In multiple-detector-row (multislice) CT scanners, several detector elements may be grouped together to form 1 data channel. In single-detector-row (single-slice) CT, the z-axis collimation (T) is the nominal scan width.

"CTDI100" means the accumulated multiple scan dose at the center of a 100-mm scan and underestimates the accumulated dose for longer scan lengths. It is thus smaller than the equilibrium dose. The CTDI100, requires integration of the radiation dose profile from a single axial scan over specific integration limits. In the case of CTDI100, the integration limits are +50 millimeters, which corresponds to the 100-mm length of the commercially available "pencil" ionization chamber. CTDI100 is acquired using a 100-mm long, 3-cc active volume CT "pencil" ionization chamber and 1 of the 2 standard CTDI acrylic phantoms (16 and 32 centimeters diameter) and a stationary patient table. The equation is:

"CTDIvol" see "Volume Computed Tomography Dose Index (CTDIvol)"

"CTDIw" see "Weighted Computed Tomography Dose Index (CTDIw)"

"Cone Beam Computed Tomography (CBCT)" is a volumetric imaging modality. Volumetric data are acquired using 2-dimensional digital detector arrays, and a cone-shaped X-ray beam (instead of fan-shaped) that rotates around the patient. Reconstruction algorithms can be used to generate images of any desired plane.

"Control panel" means that part of the X-ray control upon which are mounted the switches, knobs, pushbuttons, keypads, touchscreens, and other hardware necessary for manually setting the technique factors.

"Cradle" means:

(1) A removable device which supports and may restrain a patient above an X-ray table; or

(2) A device;

(i) Whose patient support structure is interposed between the patient and the image receptor during normal use;

(ii) Which is equipped with means for patient restraint; and

(iii) Which is capable of rotation about its long (longitudinal) axis.

"CT" (See "Computed tomography").

"CT conditions of operation" means all selectable parameters governing the operation of a CT X-ray system including nominal tomographic section thickness, filtration, and the technique factors as defined in Part F, Section 2.0.

"CT gantry" means tube housing assemblies, beam-limiting devices, detectors, and the supporting structures, frames, and covers which hold and/or enclose these components within a computed tomography system.

"CT number" means the number used to represent the X-ray attenuation associated with each elemental area of the CT image:

CTN = k(ux - uw)

uw

where:

k = A constant, a normal value of 1,000 when the Houndsfield scale of CT number is used;

ux = Linear attenuation coefficient of the material of interest;

uw = Linear attenuation coefficient of water.

"Cumulative air kerma" means the total air kerma accrued from the beginning of an examination or procedure and includes all contributions from fluoroscopic and radiographic irradiation.

"Detector" (See "Radiation detector")

"Diagnostic reference level" (DRL) is an investigational level used to identify unusually high radiation doses or dose rates for common medical X-ray imaging procedures. DRLs are suggested action levels above which a facility should review its methods and determine if acceptable image quality can be achieved at lower doses. DRLs should not be applied to an individual patient.

"Diagnostic source assembly" means the tube housing assembly with a beam-limiting device attached.

"Diagnostic X-ray system" means an X-ray system designed for irradiation of any part of the human [or animal] body for the purpose of diagnosis or visualization.

"Digital radiography (DR)" means an X-ray imaging method (or radiography) which produces a digital rather than analog image. DR includes both computed radiography and direct digital radiography.

"Direct digital radiography (DDR; also see CR and DR)" means an X-ray imaging method in which a digital sensor, usually incorporating a thin-film transistor, is used to capture an X-ray image. Some DDR systems use a scintillator to convert X-rays to light and a photodiode array to convert light to charge, while others use a photoconductor to convert X-rays directly to charge, which is stored on the thin-film transistor.

"Direct scattered radiation" means that scattered radiation which has been deviated in direction only by materials irradiated by the useful beam (See "Scattered radiation").

"Direct supervision" means that the physician providing supervision must be "immediately available" and "interruptible" to provide assistance and direction throughout the performance of the procedure; however, he or she does not need to be present in the room when the procedure is performed.

"Dose" means the absorbed dose as defined by the International Commission on Radiation Units and Measurements. The absorbed dose, D, is the quotient of de by dm, where de is the mean energy imparted to matter of mass dm; thus D=de/dm, in units of J/kg, where the special name of the unit of absorbed dose is gray (Gy).

"Dose area product (DAP) (aka kerma-area product (KAP))" means the product of the air kerma and the area of the irradiated field and is typically expressed in Gy-cm2, so it does not change with distance from the X-ray tube.

"Dose length product (DLP)" means the indicator of the integrated radiation dose from a complete CT examination. It addresses the total scan length by the formula:

DLP (mGy-cm) = CTDIvol (mGy) x scan length (cm)

"Dose profile" means the dose as a function of position along a line.

"Effective dose (E)" means the sum of the tissue-weighted equivalent doses for the radiosensitive tissues and organs of the body. It is given by the expression E = ?T (wT HT), in which HT is the equivalent dose in tissue or organ T and wT is the tissue weighting factor for tissue or organ T. The unit of E and HT is joule per kilogram (J·kg-1), with the special name sievert (Sv).

"Equipment" (See "X-ray equipment") means X-ray equipment.

"Exposure (X)" means the quotient of dQ by dm where dQ is the absolute value of the total charge of the ions of one sign produced in air when all the electrons and positrons liberated or created by photons in air of mass dm are completely stopped in air; thus X=dQ/dm, in units of C/kg. A second meaning of exposure is the process or condition during which the X-ray tube produces X-ray radiation.

"Field emission equipment" means equipment which uses an X-ray tube in which electron emission from the cathode is due solely to the action of an electric field.

"Filter" means material placed in the useful beam to preferentially absorb selected radiations.

"Fluoroscopic imaging assembly" means a subsystem in which X-ray photons produce a set of fluoroscopic images or radiographic images recorded from the fluoroscopic image receptor. It includes the image receptor(s), electrical interlocks, if any, and structural material providing linkage between the image receptor and diagnostic source assembly.

"Fluoroscopic irradiation time" means the cumulative duration during an examination or procedure of operator-applied continuous pressure to the device, enabling X-ray tube activation in any fluoroscopic mode of operation.

“Fluoroscopically-Guided Interventional (FGI) Procedures" means an interventional diagnostic or therapeutic procedure performed via percutaneous or other access routes, usually with local anesthesia or intravenous sedation, which uses external ionizing radiation in the form of fluoroscopy to localize or characterize a lesion, diagnostic site, or treatment site, to monitor the procedure, and to control and document therapy.

"Fluoroscopy" means a technique for generating X-ray images and presenting them simultaneously and continuously as visible images. This term has the same meaning as the term "radioscopy" in the standards of the International Electrotechnical Commission.

"Focal spot (actual)" means the area projected on the anode of the X-ray tube bombarded by the electrons accelerated from the cathode and from which the useful beam originates.

"General purpose radiographic X-ray system" means any radiographic X-ray system which, by design, is not limited to radiographic examination of specific anatomical regions.

"General supervision" the physician must be available by telephone to provide assistance and direction if needed.

"Half-value layer (HVL)" means the thickness of specified material which attenuates the beam of radiation to an extent such that the AKR is reduced by 1/2 of its original value. In this definition, the contribution of all scattered radiation, other than any which might be present initially in the beam concerned, is deemed to be excluded.

"Hand-held X-ray equipment" means X-ray equipment that is designed to be hand-held during operation.

"Healing arts screening" means the testing of human beings using X-ray machines for the detection or evaluation of health indications when such tests are not specifically and individually ordered by a licensed practitioner of the healing arts legally authorized to prescribe such X-ray tests for the purpose of diagnosis or treatment.

"Heat unit" means a unit of energy equal to the product of the peak kilovoltage, milliamperes, and seconds, i.e., kVp x mA x second.

"HVL" (See "Half-value layer").

"Image intensifier" means a device, installed in its housing, which instantaneously converts an X-ray pattern into a corresponding light image of higher intensity.

"Image receptor" means any device, such as a fluorescent screen, radiographic film, X-ray image intensifier tube, solid-state detector, or gaseous detector which transforms incident X-ray photons either into a visible image or into another form which can be made into a visible image by further transformations. In those cases where means are provided to preselect a portion of the image receptor, the term "image receptor" shall mean the preselected portion of the device.

"Irradiation" means the exposure of matter to ionizing radiation.

"Isocenter" means the center of the smallest sphere through which the beam axis passes when the equipment moves through a full range of rotations about its common center.

"Kerma" means the quantity defined by the International Commission on Radiation Units and Measurements. The kerma, K, is the quotient of dEtr by dm, where dEtr is the sum of the initial kinetic energies of all the charged particles liberated by uncharged particles in a mass dm of material; thus K=dEtr/dm, in units of J/kg, where the special name for the unit of kerma is gray (Gy). When the material is air, the quantity is referred to as "air kerma."

"Kerma-area product (KAP)" (See "dose area product")

"Kilovolts peak" (See "Peak tube potential").

"kV" means kilovolts.

"kVp" (See "Peak tube potential").

"kWs" means kilowatt second.

"Last-image hold (LIH) radiograph" means an image obtained either by retaining 1 or more fluoroscopic images, which may be temporarily integrated, at the end of a fluoroscopic exposure or by initiating a separate and distinct radiographic exposure automatically and immediately in conjunction with termination of the fluoroscopic exposure.

"Lead equivalent" means the thickness of lead affording the same attenuation, under specified conditions, as the material in question.

"Leakage radiation" means radiation emanating from the diagnostic source assembly except for:

(1) The useful beam; and

(2) Radiation produced when the exposure switch or timer is not activated.

"Leakage technique factors" means the technique factors associated with the diagnostic source assembly which are used in measuring leakage radiation. They are defined as follows:

(1) For diagnostic source assemblies intended for capacitor energy storage equipment, the maximum-rated peak tube potential and the maximum-rated number of exposures in an hour for operation at the maximum-rated peak tube potential with the quantity of charge per exposure being 10 millicoulombs (or 10 mAs) or the minimum obtainable from the unit, whichever is larger;

(2) For diagnostic source assemblies intended for field emission equipment rated for pulsed operation, the maximum-rated peak tube potential and the maximum-rated number of X-ray pulses in an hour for operation at the maximum-rated peak tube potential; and

(3) For all other diagnostic source assemblies, the maximum-rated peak tube potential and the maximum-rated continuous tube current for the maximum-rated peak tube potential.

"Licensed practitioner" means an individual licensed to practice medicine, dentistry, podiatry, chiropractic, osteopathy, or veterinary medicine in this state. For the purpose of this regulation, advanced practice registered nurses (APRN) and physicians assistants (PA) may order diagnostic or supportive X-ray procedures for patients in accordance with Title 24, Delaware Code. APRNs and PAs who supervise, perform, view or interpret x-ray procedures do so within their scope of practice, as governed by Title 24, Delaware Code.

"Light field" means that area of the intersection of the light beam from the beam-limiting device and one of the set of planes parallel to and including the plane of the image receptor, whose perimeter is the locus of points at which the illumination is 1/4 of the maximum in the intersection.

"Line-voltage regulation" means the difference between the no-load and the load line potentials expressed as a percent of the load line potential; that is,

Percent line-voltage regulation = 100 (Vn-Vl)/Vl

where:

Vn = No-load line potential; and

Vl = Load line potential.

"mA" means milliampere.

"mAs" means milliampere second.

"Medical event" means 1 or more of the following criteria have occurred:

a. Event which results in an unintended dose greater than:

i. 0.5 Gy (50 rad) to any organ or tissue, or

ii. 0.05 Sv (5 rem) total effective dose equivalent for the procedure, or

b. Event involves wrong patient or wrong site for entire diagnostic exam (procedure/service) and

i. exceeds 0.5 Gy (50 rad) to an organ or tissue, or

ii. exceeds 0.05 Sv (5 rem) total effective dose equivalent for the procedure, or

c. Involves any equipment failure, personnel error, accident, mishap or other unusual occurrence with the administration of ionizing radiation that exceeds:

i. 0.5 Gy (50 rad) to an organ or tissue, or

ii. 0.05 Sv (5 rem) total effective dose equivalent for the procedure.

"Mobile X-ray equipment" (See "X-ray equipment").

"Mode of operation" means, for fluoroscopic systems, a distinct method of fluoroscopy or radiography provided by the manufacturer and selected with a set of several technique factors or other control settings uniquely associated with the mode. The set of distinct technique factors and control settings for the mode may be selected by the operation of a single control. Examples of distinct modes of operation include normal fluoroscopy (analog or digital), high-level control fluoroscopy, cineradiography (analog and digital), digital subtraction angiography, electronic radiography using the fluoroscopic image receptor, and photospot recording. In a specific mode of operation, certain system variables affecting kerma, AKR, or image quality, such as image magnification, X-ray field size, pulse rate, pulse duration, number of pulses, source-image receptor distance (SID), or optical aperture, may be adjustable or may vary; their variation per se does not comprise a mode of operation different from the one that has been selected.

"Multiple tomogram system" means a computed tomography X-ray system which obtains X-ray transmission data simultaneously during a single scan to produce more than 1 tomogram.

"Noise" in CT means the standard deviation of the fluctuations in CT number expressed as a percentage of the attenuation coefficient of water. Its estimate (Sn) is calculated using the following expression:

where:

CS = Linear attenuation coefficient of the material of interest.

uw = Linear attenuation coefficient of water.

s = Estimated [S]standard deviation of the CT numbers of picture elements in a specified area of the CT image.

"Nominal tomographic section thickness" means the full width at half-maximum of the sensitivity profile taken at the center of the cross-sectional volume over which X-ray transmission data are collected.

"Notification value" means a protocol-specific dose index (e.g. CTDIvol(mGy) or of DLP(mGy-cm)) that is set by the registrant to trigger a notification to the CT operator prior to scanning when the dose index exceeds the established range for the examination.

"Patient" means an individual or animal subjected to healing arts examination, diagnosis or treatment.

"Picture element" means an elemental area of a tomogram.

"PBL" See "Positive beam limitation."

"Peak tube potential" means the maximum value of the potential difference across the X-ray tube during an exposure.

“Personal supervision" means that the physician must be in attendance in the room during the procedure.

"Phantom" means a volume of material behaving in a manner similar to tissue with respect to the attenuation and scattering of radiation. This requires that both the atomic number (Z) and the density of the material be similar to that of tissue.

"Photostimulable storage phosphor (PSP)" means a material used to capture and store radiographic images in computed radiography systems.

"PID" (See "Position indicating device").

"Pitch" means the table incrementation, in CT, per X-ray tube rotation, divided by the nominal X-ray beam width at isocenter.

"Portable X-ray equipment" (See "X-ray equipment").

"Position indicating device (PID)" means a device on dental X-ray equipment used to indicate the beam position and to establish a definite source-surface (skin) distance. It may or may not incorporate or serve as a beam-limiting device.

"Positive beam limitation" means the automatic or semi-automatic adjustment of an X-ray beam to the size of the selected image receptor, whereby exposures cannot be made without such adjustment.

"Primary protective barrier" means the material, excluding filters, placed in the useful beam to reduce the radiation exposure [beyond the patient and cassette holder] for protection purposes.

"Principal Supervisor" means the licensed practitioner responsible for initiating use of X-ray equipment or other device generating ionizing radiation in the healing arts.

"Protective apron" means an apron made of radiation absorbing materials used to reduce radiation exposure.

"Protocol" means a collection of settings and parameters that fully describe an examination.

"Pulsed mode" means operation of the X-ray system such that the X-ray tube current is pulsed by the X-ray control to produce one or more exposure intervals of duration less than 1/2 second.

"Qualified expert (QE)" means an individual who has satisfactorily fulfilled the training and experience requirements consistent with achieving a level of competency sufficient to function effectively in the position for which State Radiation Service Provider registration is sought in accordance with Regulation 4465, Part B. Such individuals must demonstrate to the satisfaction of the Agency their qualifications, for example formal education or individuals certified in the appropriate field by the American Board of Radiology, or the American Board of Health Physics, or the American Board of Medical Physics, or those having equivalent qualifications. With reference to the calibration of radiation therapy equipment, an individual, in addition to the above qualifications, must be qualified in accordance with Regulation 4465, Part F and Regulation 4465, Part X of these regulations, as amended.

"Quality Assurance" means a program providing for verification by written procedures such as testing, auditing, and inspection to ensure that deficiencies, deviations, defective equipment, or unsafe practices, or a combination thereof, relating to the use, disposal, management, or manufacture of radiation devices are identified, promptly corrected, and reported to the appropriate regulatory authorities as required.

"Qualified Medical Physicist (QMP)" means an individual who meets each of the following credentials:

1. Has earned a master's and/or doctoral degree in physics, medical physics, biophysics, radiological physics, medical health physics, or equivalent disciplines from an accredited college or university; and

2. Has been granted certification in the specific subfield(s) of medical physics with its associated medical health physics aspects by an appropriate national certifying body and abides by the certifying body's requirements for continuing education; and/or

3. Is credentialed in accordance with Regulation 4465, Part X, Therapeutic Radiation machines, subsection 3.4, as amended.

"Radiation detector" means a device which in the presence of radiation provides a signal or other indication suitable for use in measuring 1 or more quantities of incident radiation.

"Radiation Protocol Committee (RPC)" means the representative group of qualified individuals in a CT or FGI facility responsible for the ongoing review and management of CT or FGI protocols to ensure that exams being performed achieve the desired diagnostic image quality at the lowest radiation dose possible while properly exploiting the capabilities of the equipment being used.

"Radiation therapy simulation system" means a radiographic, computed tomography or fluoroscopic X-ray system intended for localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field.

"Radiograph" means an image receptor on which the image is created directly or indirectly by an X-ray pattern and results in a permanent record.

"Radiography" means a technique for generating and recording an X-ray pattern for the purpose of providing the user with an image(s) after termination of the exposure.

"Recording" means producing a retrievable form of an image resulting from X-ray photons.

"Reference plane" means a plane which parallel to and which can be offset (as specified in manufacturer information provided to users) from the location of the tomographic plane(s).

"Scan" means the complete process of collecting x-ray transmission data for the production of a tomogram. Data may be collected simultaneously during a single scan for the production of 1 or more tomograms.

"Scan increment" means the amount of relative displacement of the patient with respect to the CT X-ray system between successive scans measured along the direction of such displacement.

"Scan sequence" means a pre-selected set of 2 or more scans performed consecutively under pre-selected CT conditions of operation.

"Scan time" means the time elapsed during the accumulation of X-ray transmission data for a single scan.

"Scattered radiation" means radiation that, during passage through matter, has been deviated in direction (See "Direct scattered radiation").

"Sensitivity profile" means the relative response of the CT X-ray system as a function of position along a line perpendicular to the tomographic plane.

"Single tomogram system" means a CT X-ray system which obtains X-ray transmission data during a scan to produce a single tomogram.

"Shutter" means a device attached to the tube housing assembly which can intercept the entire cross sectional area of the useful beam and which has a lead equivalency not less than that of the tube housing assembly.

"SID" (See "Source-image receptor distance").

"Size-specific dose estimate (SSDE)" means a patient dose estimate which takes into consideration corrections based on the size of the patient, using linear dimensions measured on the patient or patient images.

"Source" means the focal spot of the X-ray tube.

"Source-image receptor distance" means the distance from the source to the center of the input surface of the image receptor.

"Source-skin distance (SSD)" means the distance from the source to the center of the entrant X-ray field in the plane tangent to the patient skin surface.

"Spot-film" means a radiograph which is made during a fluoroscopic examination to permanently record conditions which exist during that fluoroscopic procedure.

“Spot-film device” means a device intended to transport and/or position a radiographic image receptor between the X-ray source and fluoroscopic image receptor. It includes a device intended to hold a cassette over the input end of the fluoroscopic image receptor for the purpose of producing a radiograph.

"Stationary X-ray equipment" (See "X-ray equipment").

"Stray radiation" means the sum of leakage and scattered radiation.

"Substantial radiation dose level" (SRDL) means an appropriately-selected dose used to trigger additional dose-management actions during a procedure and medical follow-up for a radiation level that might produce a clinically-relevant injury in an average patient.

"Technique factors" means the following conditions of operation:

(1) For capacitor energy storage equipment, peak tube potential in kilovolts (kV) and quantity of charge in milliampere-seconds (mAs);

(2) For field emission equipment rated for pulsed operation, peak tube potential in kV, and number of X-ray pulses;

(3) For CT equipment designed for pulsed operation, peak tube potential in kV, scan time in seconds, and either tube current in milliamperes (mA), X-ray pulse width in seconds, and the number of X-ray pulses per scan, or the product of tube current, X-ray pulse width, and the number of X-ray pulses in mAs;

(4) For CT equipment not designed for pulsed operation, peak tube potential in kV, and either tube current in mA and scan time in seconds, or the product of tube current and exposure time in mAs and the scan time when the scan time and exposure time are equivalent; and

(5) For all other equipment, peak tube potential in kV, and either tube current in mA and exposure time in seconds, or the product of tube current and exposure time in mAs.

"Tomogram" means the depiction of the X-ray attenuation properties of a section through the body.

"Tomographic plane" means that geometric plane which the manufacturer identified as corresponding to the output tomogram.

"Tomographic section" means the volume of an object whose X-ray attenuation properties are imaged in a tomogram.

"Tube" means an X-ray tube, unless otherwise specified.

"Tube housing assembly" means the tube housing with tube installed. It includes high-voltage and/or filament transformers and other appropriate elements when such are contained within the tube housing.

"Unintended" radiation dose in diagnostic or interventional X-ray means a patient radiation dose determined to have resulted from a human error or equipment malfunction during the procedure.

"Useful beam" means the radiation which passes through the tube housing port and the aperture of the beam limiting device when the exposure switch or timer is activated.

"Visible area" means that portion of the input surface of the image receptor over which incident X-ray photons are producing a visible image.

"Volume Computed Tomography Dose Index (CTDIvol)" means a radiation dose parameter derived from the CTDIw (weighted or average CTDI given across the field of view). The formula is:

CTDIvol = (N)(T)(CTDIw)/I

where

N = number of simultaneous axial scans per X-ray source rotation,

T = thickness of 1 axial scan (mm), and

I = table increment per axial scan (mm).

Thus,

CTDIvol = CTDIw / pitch

"Weighted Computed Tomography Dose Index (CTDIw)" means the estimated average CTDI100 across the field of view (FOV). The equation is:

Where 1/3 and 2/3 approximate the relative areas represented by the center and edge values derived using the 16 or 32 centimeters acrylic phantom. CTDIw uses CTDI100 and an f-factor for air (0.87 rad/R or 1.0 mGy/mGy).

"X-ray control" means a device which controls input power to the X-ray high-voltage generator and/or the X-ray tube. It includes equipment such as timers, phototimers, automatic brightness stabilizers, and similar devices, which control the technique factors of an X-ray exposure.

"X-ray exposure control" means a device, switch, button or other similar means by which an operator initiates and/or terminates the radiation exposure. The X-ray exposure control may include such associated equipment as timers and back-up timers.

"X-ray equipment" means an X-ray system, subsystem, or component thereof. Types of X-ray equipment are as follows:

(1) "Mobile X-ray equipment" means X-ray equipment mounted on a permanent base with wheels and/or casters for moving while completely assembled;

(2) "Portable X-ray equipment" means X-ray equipment designed to be hand-carried; and

(3) "Stationary X-ray equipment" means X-ray equipment which is installed in a fixed location.

(4) "Hand-held X-ray equipment" means X-ray equipment that is designed to be hand-held during operation.

"X-ray field" means that area of the intersection of the useful beam and any one of a set of planes parallel to and including the plane of the image receptor, whose perimeter is the locus of points at which the AKR is 1/4 of the maximum in the intersection.

"X-ray high-voltage generator" means a device which transforms electrical energy from the potential supplied by the X-ray control to the tube operating potential. The device may also include means for transforming alternating current to direct current, filament transformers for the X-ray tube(s), high-voltage switches, electrical protective devices, and other appropriate elements.

"X-ray system" means an assemblage of components for the controlled production of X-rays. It includes minimally an X-ray high-voltage generator, an X-ray control, a tube housing assembly, a beam-limiting device, and the necessary supporting structures. Additional components which function with the system are considered integral parts of the system.

"X-ray table" means a patient support device with its patient support structure (tabletop) interposed between the patient and the image receptor during radiography and/or fluoroscopy. This includes, but is not limited to, any stretcher equipped with a radiolucent panel and any table equipped with a cassette tray (or bucky), cassette tunnel, fluoroscopic image receptor, or spot-film device beneath the tabletop.

"X-ray tube" means any electron tube which is designed for the conversion of electrical energy into X-ray energy.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-3.0** General and Administrative Requirements {#sec-4465-3.0 omnilex-key=us-de-regs-official--title-16--4465-3.0}

3.1 Radiation Safety Requirements. The registrant shall be responsible for directing the operation of the X-ray system(s) under his or her administrative control and shall assure that the requirements of these regulations are met in the operation of the X-ray system(s).

3.1.1 The registrant shall have a radiation safety program. The radiation safety program shall include but not be limited to the following:

3.1.1.1 The use of ionizing radiation within its purview is performed in accordance with existing laws and regulations.

3.1.1.2 All persons are protected as required by Regulation 4465, Part D, Standards for Protection Against Radiation, of these regulations.

3.1.1.3 Upon discovery of a medical event, the registrant shall:

3.1.1.3.1 Contact the Agency regarding the medical event within 1 business day;

3.1.1.3.2 Provide a written report, including the analysis of the medical event, by a QMP (QE) to the Agency within 15 business days;

3.1.1.3.3 Provide a clinical summary to the prescribing physician and patient within 15 business days; and

3.1.1.4 Maintain record of the medical event as part of the patient's permanent medical record; and

3.1.1.5 Maintain record of the medical event as reported to Radiation Protocol or Safety Committee for at least 3 years, available for inspection.

3.1.2 An X-ray system which does not meet the provisions of these regulations shall not be operated for diagnostic or interventional purposes unless the Agency or a QMP (QE) determines that the non-compliance shall not pose a significant radiation risk or significantly affect image quality, and arrangements have been made to correct the non-compliance within 30 days.

3.1.3 The QMP (QE), if required in this Part, shall complete initial and routine compliance evaluations following nationally recognized procedures. These evaluations shall include a review of the required QC tests.

3.1.4 All X-ray equipment shall be installed, maintained, and used in accordance with the equipment manufacturer's specifications.

3.1.5 Individuals operating the X-ray systems shall meet the qualifications required by the Agency.

3.1.6 A sufficient number of protective apparel (e.g., aprons, gloves, collars) and shields shall be available to provide the necessary radiation protection for all patients and personnel who are involved with X-ray operations.

3.1.7 All protective apparel and auxiliary shields shall be evaluated annually for integrity and clearly labeled with their lead equivalence.

3.1.8 Each registrant should have a mechanism in place for the referring licensed practitioner to access information on selecting the most appropriate diagnostic procedure to answer the clinical question.

3.1.9 Nationally recognized diagnostic reference levels (DRLs) should be utilized when applicable.

3.1.10 The registrant shall use dose reduction strategies designed to minimize patient and personnel exposure commensurate with the needed diagnostic information.

3.1.11 Portable or mobile X-ray equipment shall be used only for examinations where it is impractical to transfer the patient to a stationary X-ray installation.

3.1.12 Neither the X-ray tube housing nor the collimating device shall be held during an exposure. An exemption or variance is required for devices specifically designed to be hand-held, except for devices in non-human use, such as veterinary medicine or forensics.

3.1.13 The useful X-ray beam shall be limited to the area of clinical interest.

3.1.14 Consideration shall be given to selecting the appropriate technique and employing available dose reduction methods and technologies across all patient sizes and clinical indications.

3.1.15 A facility shall have a documented procedure in place for verification of patient identity and exam to be performed, including identification of the appropriate body part.

3.1.16 For general radiographic systems not equipped with an operational anatomic programming option, protocols shall be documented and readily available to the operator. At a minimum, these protocols shall include:

3.1.16.1 Patient's (adult and pediatric, if appropriate) body part and anatomical size

3.1.16.2 Technique factors

3.1.16.3 Type of image receptor used

3.1.16.4 Source to image receptor distance used (except for dental intraoral radiography)

3.1.16.5 Type of grid, if any.

3.1.17 The registrant shall create and make available to X-ray operators written safety procedures, including instructions for patient holding and any restrictions of the operating technique required for the safe operation of the particular X-ray system. The operator shall be able to demonstrate familiarity with these procedures.

3.1.18 The registrant shall restrict the presence of individuals in the immediate area of the patient being examined to those required or in training for the medical procedure, or the parent or guardian of a patient while the X-ray tube is energized. The following applies to all individuals, other than the patient being examined:

3.1.18.1 All persons shall be positioned such that no part of the body will be struck by the useful beam unless protected by not less than 0.5 millimeter lead equivalent material;

3.1.18.2 All persons shall be protected from the secondary radiation by protective garments or whole body protective barriers of not less than 0.25 millimeter lead equivalent material;

3.1.18.3 Instances may warrant having human patients other than the one being examined in the room during the exam. If the procedure results in scatter radiation in excess of 0.02 mSv (2 mR) in any 1 hour at the position of these patients, they shall be protected from the direct scatter radiation by whole body protective barriers of not less than 0.25 millimeter lead equivalent material or shall be positioned so that the 0.02 mSv (2 mR) in any 1 hour limit is met.

3.1.19 Individuals shall not be exposed to the useful beam except for healing arts purposes and unless such exposure has been authorized by a licensed practitioner. This provision specifically prohibits deliberate exposure for the following purposes:

3.1.19.1 Exposure of an individual for training, demonstration, or other non-healing arts purposes; and

3.1.19.2 Exposure of an individual for the purpose of healing arts screening except as authorized by the Agency, or under the following circumstances: Exposure of an individual to the useful beam when conducting research approved by an Institutional Review Board (IRB) as allowed by Title 45, Code of Federal Regulations (CFR), Part 46 and Title 21,CFR, Part 56.

3.1.20 In cases where a patient or image receptor must be provided with auxiliary support, mechanical support devices shall be used whenever possible. If a patient or image receptor must be provided with auxiliary support during a radiation exposure:

3.1.20.1 Written safety procedures, as required by Part F, subsection 3.1.15, shall indicate the requirements for selecting a holder and the procedure the holder shall follow;

3.1.20.2 The human holder shall be instructed in personal radiation safety and protected as required by Part F, subsection 3.1.16;

3.1.20.3 No individual shall be used routinely to hold the image receptor or patient during a radiation exposure;

3.1.20.4 In those cases where the patient must hold the image receptor, except during intraoral examinations, any portion of the body other than the area of clinical interest struck by the useful beam shall be protected by not less than 0.5 millimeter lead equivalent material.

3.1.21 All individuals who are associated with the operation of an X-ray system are subject to the requirements of Part D of these regulations.

3.1.22 Healing Arts Screening. Any person proposing to conduct a healing arts screening program shall not initiate such a program without prior approval of the Agency. When requesting such approval, that person shall submit the information outlined in Appendix A of Part F of these regulations. If any information submitted to the Agency becomes invalid or outdated, the Agency shall be immediately notified. FDA/MQSA-certified facilities are registered with the Agency for the use of dedicated mammographic equipment to conduct mammography screening.

3.1.23 Maintenance of Records. The registrant shall maintain the following information on each X-ray system for inspection by the Agency for a minimum of 5 years or as noted below:

3.1.23.1 Model and serial numbers of all major components, and user's manuals for those components, including software, shall be maintained for the life of the system.

3.1.23.2 Records of surveys, calibrations, maintenance, and modifications (e.g., major software and hardware upgrades) performed on the X-ray system(s); and

3.1.23.3 A copy of all correspondence with the Agency regarding the X-ray system.

3.1.24 X-Ray Utilization Record. Each facility shall maintain a record containing the patient's name, the type of examinations, and the dates the examinations were performed.

3.2 Quality Assurance

3.2.1 The registrant shall establish and maintain a quality assurance (QA) program. In addition to the standards in the modality specific sections, the registrant shall:

3.2.1.1 Maintain documentation of minimum qualifications for licensed practitioners, medical physicists, and X-ray equipment operators.

3.2.1.2 Designate an appropriately trained individual to manage the QA program.

3.2.1.3 Establish and maintain written QA and quality control (QC) procedures, including evaluation frequencies and tolerances.

3.2.1.4 Check each study for artifacts. If an artifact is present, the source shall be identified and appropriate action taken.

3.2.1.5 Perform repeat / reject analysis of radiographic images at least quarterly following specifications of a nationally recognized organization.

3.2.1.6 Complete preventative maintenance on each X-ray system in accordance with manufacturer specifications at intervals, not to exceed 24 months.

3.2.1.7 Maintain documentation showing the testing instruments used in determining compliance with the provisions of this section are properly calibrated and maintained in accordance with accepted professional standards.

3.2.1.8 Complete and document an annual review of the QA program.

3.2.1.9 Retain QA/QC records of evaluations and reviews in accordance with state statutes, regulations, but in no case less than 3 years.

3.2.2 X-Ray Film Processing Facilities. A registrant using analog image receptors (e.g. radiographic film) shall have available suitable equipment for handling and processing radiographic film in accordance with the following provisions:

3.2.2.1 Manually developed film:

3.2.2.1.1 Processing tanks shall be constructed of mechanically rigid, corrosion resistant material; and

3.2.2.1.2 Developing solutions shall be prepared, replenished, and replaced following manufacturer recommendations.

3.2.2.1.3 The temperature of solutions in the tanks shall be maintained within the range of 60o F to 80o F (16o C to 27o C). Film shall be developed in accordance with the time-temperature relationships recommended by the film manufacturer, or, in the absence of such recommendations, with the following time-temperature chart:

3.2.2.1.4 Devices shall be utilized which will indicate the actual temperature of the developer solution and signal the passage of a preset time.

3.2.3 Automatic processors and other closed processing systems:

3.2.3.1 Automatic processors shall be operated and maintained following manufacturer specifications.

3.2.3.2 Films shall be developed in accordance with the time-temperature relationships recommended by the film manufacturer; in the absence of such recommendations, the film shall be developed using the following chart:

3.2.3.3 Processing deviations from the requirements of Part F, subsection 3.2.2 shall be documented by the registrant in such manner that the requirements are shown to be met or exceeded (e.g., extended processing, and special rapid chemistry).

3.2.4 Additional Requirements for Facilities using X-ray Film.

3.2.4.1 Pass boxes, if provided, shall be so constructed as to exclude light from the darkroom when cassettes are placed in or removed from the boxes, and shall incorporate adequate shielding from stray radiation to prevent exposure of undeveloped film.

3.2.4.2 Darkrooms typically used by more than 1 individual shall be provided a method to prevent accidental entry while undeveloped films are being handled or processed.

3.2.4.3 Film shall be stored in a cool, dry place and shall be protected from exposure to stray radiation. Film in open packages shall be stored in a light tight container.

3.2.4.4 Film cassettes and intensifying screens shall be inspected periodically and shall be cleaned and replaced as necessary.

3.2.4.5 Outdated X-ray film shall not be used for diagnostic radiographs.

3.2.4.6 The film and intensifying screen shall be spectrally compatible.

3.2.4.7 Facilities shall maintain a light-tight darkroom, use proper safelighting and safeguards, and evaluate darkroom integrity and daylight loading systems for film fog every 6 months and after a change that may impact film fog.

3.2.4.8 Facilities other than dental, podiatry, and veterinary shall:

3.2.4.8.1 Have a continuous and documented sensitometric quality control program, including quality control tests for speed, contrast and fog, These tests shall be performed according to specifications of the manufacturer, a QMP (QE), or a nationally recognized organization.

3.2.4.8.2 Maintain a light-tight darkroom and use proper safelighting and safeguards such that any film type in use exposed in a cassette to X-radiation sufficient to produce an optical density from 1 to 2 when processed shall not suffer an increase in optical density greater than 0.1 when exposed in the darkroom for 2 minutes with all safelights on. If used, daylight film handling boxes shall preclude fogging of the film.

3.2.4.8.3 Limit the base plus fog of unexposed film to an optical density less than 0.25 when developed by the routine procedure used by the facility.

3.2.5 Facilities Using Computed Radiography (CR) or Direct Digital Radiography (DDR)

3.2.5.1 When exposure indicators are available, the facility shall establish and document an acceptable range for the exposure values for examinations routinely performed at the facility. The indicated exposure values for each image shall be compared to the established range. Consistent deviations from established ranges shall be investigated, corrective actions taken as necessary, and results documented.

3.2.5.2 Facilities shall establish and follow an image quality control program in accord with the recommendations of a QMP (QE), the system manufacturer, or a nationally recognized organization.

3.2.5.3 Facilities other than dental, podiatric and veterinary, shall complete phantom image evaluation using a phantom approved by a QMP (QE), or the system manufacturer. The analysis at a minimum shall include: artifacts, spatial resolution, contrast/noise, workstation monitors, and exposure indicator constancy.

3.2.5.4 In addition to Part F, subsections 3.2.4.1 through 3.2.4.3, CR facilities shall perform erasure of all CR cassettes, at least on a weekly basis.

3.3 Exemptions

3.3.1 Dental facilities. Dental facilities performing only intra-oral, panoramic, cephalometric or volumetric dental imaging are exempt from the following provisions of this Section: Part F, subsection 3.1.8 (information available to referring physician) and Part F, subsection 3.2.1.5 (repeat analysis).

3.3.2 Podiatry facilities. Podiatry facilities are exempt from the following provisions of this Section: Part F, subsection 3.1.8 (information available to referring physician) and Part F, subsection 3.2.1.5 (repeat analysis).

3.3.3 Veterinary facilities. Veterinary facilities are exempt from the following provisions of this Section: Part F, subsection 3.1.8 (information available to referring physician), Part F, subsection 3.1.9 (use of reference levels), Part F, subsection 3.1.14 (use of dose reduction techniques), Part F, subsection 3.1.15 (patient identification), Part F, subsection 3.1.14 (protocol control), Part F, 3.1.18.3 (routine holding of patient), Part F, subsection 3.1.22 (healing arts screening), Part F, subsection 3.2.1.5 (repeat analysis), and Part F, subsection 3.2.4.8.1 (use of sensitometric equipment).

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-4.0** General Requirements for All Diagnostic and Interventional X-Ray Systems {#sec-4465-4.0 omnilex-key=us-de-regs-official--title-16--4465-4.0}

4.1 In addition to other requirements of this Part, all diagnostic and interventional X-ray systems shall meet the following requirements. Requirements specific to dental intra-oral, panoramic, cephalometric, volumetric dental imaging equipment are included in Part F, Section 7.0

4.1.1 Warning Label

4.1.1.1 On systems manufactured on or before June 10, 2006, the control panel containing the main power switch shall bear the warning statement, or the warning statement in Part F, subsection 4.1.1, legible and accessible to view: "WARNING: This X-ray unit may be dangerous to patient and operator unless safe exposure factors, operating instructions are observed."

4.1.1.2 On systems manufactured after June 10, 2006, the control panel containing the main power switch shall bear the warning statement, legible and accessible to view: "WARNING: This X-ray unit may be dangerous to patient and operator unless safe exposure factors, operating instructions and maintenance schedules are observed."

4.2 Leakage Radiation from the Diagnostic Source Assembly. The leakage radiation from the diagnostic source assembly measured at a distance of 1 meter in any direction from the source shall not exceed 0.88 milligray (mGy) air kerma (vice 100 milliroentgen (mR) exposure) in 1 hour when the X-ray tube is operated at its leakage technique factors. If the maximum rated peak tube potential of the tube housing assembly is greater than the maximum rated peak tube potential for the diagnostic source assembly, positive means shall be provided to limit the maximum X-ray tube potential to that of the diagnostic source assembly. Compliance shall be determined by measurements averaged over an area of 100 square centimeters with no linear dimension greater than 20 centimeters (21CFR1020.30(k)).

4.3 Radiation from Components Other Than the Diagnostic Source Assembly. The radiation emitted by a component other than the diagnostic source assembly shall not exceed an air kerma of 18 microgray (vice 2 milliroentgens exposure) in 1 hour at 5 centimeters from any accessible surface of the component when it is operated in an assembled X-ray system under any conditions for which it was designed. Compliance shall be determined by measurements averaged over an area of 100 square centimeters with no linear dimension greater than 20 centimeters. (21CFR1020.30(l))

4.4 Technique Indicators

4.4.1 For X-ray equipment capable of displaying technique factors, the technique factors to be used during an exposure shall be indicated before the exposure begins. If automatic exposure controls are used, the technique factors which are set prior to the exposure shall be indicated. (21CFR1020.31(a)(1))

4.4.2 The requirement of Part F, subsection 4.4.1 may be met by permanent markings on equipment having fixed technique factors. Indication of technique factors shall be visible from the operator's position except in the case of spot films made by the fluoroscopist. (21CFR1020.31(a)(1))

4.4.3 The accuracy of the indicated kilovoltage peak (kVp) shall meet manufacturer specifications. In the absence of a manufacturer specification, kVp accuracy shall be within +10%.

4.5 Beam Quality

4.5.1 The half value layer (HVL) of the useful beam for a given X-ray tube potential shall not be less than the values shown in Table 1. If it is necessary to determine such half-value layer at an X-ray tube potential which is not listed in Table 1 of this section, linear interpolation or extrapolation may be made. Positive means shall be provided to ensure that at least the minimum filtration needed to achieve beam quality requirements is in the useful beam during each exposure. (21CFR1020.30(m)) In the case of a system, which is to be operated with more than one thickness of filtration, this requirement can be met by a filter interlocked with the kilovoltage selector which will prevent X-ray emissions if the minimum required filtration is not in place. (21 CFR 1020.30)

TABLE 1

(21CFR1020.30(m))

4.5.2 Optional filtration on fluoroscopic systems. Fluoroscopic systems manufactured on or after June 10, 2006, incorporating an X-ray tube(s) with a continuous output of 1 kilowatt or more and an anode heat storage capacity of 1 million heat units or more shall provide the option of adding X-ray filtration to the diagnostic source assembly in addition to the amount needed to meet the half-value layer provisions of this subsection. The selection of this additional X-ray filtration shall be either at the option of the user or automatic as part of the selected mode of operation. A means of indicating which combination of additional filtration is in the X-ray beam shall be provided. (21CFR1020.30(m)(2))

4.5.3 Measuring compliance. For capacitor energy storage equipment, compliance shall be determined with the maximum selectable quantity of charge per exposure.

4.6 Aluminum equivalent of material between patient and image receptor. Except when used in a CT X-ray system, the aluminum equivalent of each of the items listed in Table 2 in this paragraph, which are used between the patient and the image receptor, may not exceed the indicated limits. Compliance shall be determined by X-ray measurements made at a potential of 100 kilovolts peak and with an X-ray beam that has an HVL specified in Table 1 of this section for the potential. This requirement applies to front panel(s) of image receptors and film changers provided by the manufacturer for patient support or for prevention of foreign object intrusions. It does not apply to screens and their associated mechanical support panels or grids.

TABLE 2

4.7 Battery charge indicator. On battery-powered generators, visual means shall be provided on the control panel to indicate whether the battery is in a state of charge adequate for proper operation.

4.8 Modification of certified diagnostic X-ray components and systems.

4.8.1 Diagnostic X-ray components and systems certified in accordance with 21 CFR Part 1020 shall not be modified such that the component or system fails to comply with any applicable provision of this Part.

4.8.2 The owner of a diagnostic X-ray system who uses the system in a professional or commercial capacity may modify the system provided the modification does not result in the failure of the system or component to comply with the applicable requirements of this Part. The owner who causes such modification need not submit the reports required by this Part, provided the owner records the date and the details of the modification in the system records and maintains this information, and provided the modification of the X-ray system does not result in a failure to comply with this Part.

4.9 Multiple Tubes. Where 2 or more radiographic tubes are controlled by 1 exposure switch, the tube which has been selected shall be clearly indicated prior to initiation of the exposure. Only the selected tube can be energized. This indication shall be both on the X-ray control panel and at or near the tube housing assembly which has been selected.

4.10 Mechanical Support of Tube Head. The tube housing assembly supports shall be adjusted such that the tube housing assembly will remain stable during an exposure unless tube housing movement is a designed function of the X-ray system.

4.11 Locks. All position locking, holding, and centering devices on X-ray system components and systems shall function as intended.

4.12 Maintaining Compliance. Diagnostic X-ray systems and their associated components used on humans and certified pursuant to the Federal X-Ray Equipment Performance Standard (21 CFR Part 1020) shall be maintained in compliance with applicable requirements of that standard.

**History**
- *22 DE Reg. 401 (11/01/18)*
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- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
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- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
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- *17 DE Reg. 983 (04/01/14)*
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- *17 DE Reg. 983 (04/01/14)*
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- *22 DE Reg. 401 (11/01/18)*
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- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
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- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
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- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
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- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
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- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
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- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-5.0** Fluoroscopic Equipment. {#sec-4465-5.0 omnilex-key=us-de-regs-official--title-16--4465-5.0}

5.1 The provisions of this Part apply to equipment for fluoroscopic imaging or for recording images from the fluoroscopic image receptor. (21CFR1020.32)

5.2 Only image-intensified or direct-digital receptor fluoroscopic equipment shall be used for fluoroscopy.

5.3 Primary Protective Barrier.

5.3.1 Limitation of useful beam. The fluoroscopic imaging assembly shall be provided with a primary protective barrier which intercepts the entire cross section of the useful beam at any SID. The X-ray tube used for fluoroscopy shall not produce X-rays unless the barrier is in position to intercept the entire useful beam. The AKR due to transmission through the barrier with the attenuation block in the useful beam combined with radiation from the fluoroscopic imaging receptor shall not exceed 3.34x10-3 percent of the entrance AKR, at a distance of 10 centimeters from any accessible surface of the fluoroscopic imaging assembly beyond the plane of the image receptor. Radiation therapy simulation systems shall be exempt from this requirement provided the systems are intended only for remote control operation. (21CFR 1020.32(a)(1))

5.3.2 Measuring compliance. The AKR shall be measured in accordance with Part F, subsection 5.5. The AKR due to transmission through the primary barrier combined with radiation from the fluoroscopic image receptor shall be determined by measurements averaged over an area of 100cm2 with no linear dimension greater than 20 centimeters. If the source is below the tabletop, the measurement shall be made with the input surface of the fluoroscopic imaging assembly positioned 30 centimeters above the tabletop. If the source is above the tabletop and the SID is variable, the measurement shall be made with the end of the beam-limiting device or spacer as close to the tabletop as it can be placed, provided that it shall not be closer than 30 centimeters. Movable grids and compression devices shall be removed from the useful beam during the measurement. For all measurements, the attenuation block shall be positioned in the useful beam 10 centimeters from the point of measurement of entrance AKR and between this point and the input surface of the fluoroscopic imaging assembly. (21CFR 1020.32(a)(2))

5.4 Field Limitation

5.4.1 Angulation. For fluoroscopic equipment manufactured after February 25, 1978, when the angle between the image receptor and the beam axis of the X-ray beam is variable, means shall be provided to indicate when the axis of the X-ray beam is perpendicular to the plane of the image receptor. Compliance with Part F, subsection 5.4.3.1 and Part F, subsection 5.4.3.2 shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor. (21 CFR 1020.32(b)(1))

5.4.2 Further means for limitation. Means shall be provided to permit further limitation of the X-ray field to sizes smaller than the limits of Part F, subsection 5.4.3.1 and Part F, subsection 5.4.3.2 Beam-limiting devices manufactured after May 22, 1979, and incorporated in equipment with a variable SID and/or capability of a visible area of greater than 300 cm2, shall be provided with means for stepless adjustment of the X-ray field. Equipment with a fixed SID and the capability of a visible area of no greater than 300 cm2 shall be provided with either stepless adjustment of the X-ray field or with a means to further limit the X-ray field size at the plane of the image receptor to 125 cm2 or less. Stepless adjustment shall, at the greatest SID, provide continuous field sizes from the maximum obtainable to a field size containable in a square of 5 centimeters by 5 centimeters. (21CFR 1020.32(b)(2))

5.4.3 Spot-film devices. In addition to applicable regulations in Part F, Section 6.0 (Radiographic Equipment), the following requirements shall apply to spot-film devices, except when the spot-film device is provided for use with a radiation therapy simulation system: (21CFR1020.31(h))

5.4.3.1 Means shall be provided between the source and the patient for adjustment of the X-ray field size in the plane of the image receptor to the size of that portion of the image receptor which has been selected on the spot-film selector. Such adjustment shall be accomplished automatically when the X-ray field size in the plane of the image receptor is greater than the selected portion of the image receptor. If the X-ray field size is less than the size of the selected portion of the image receptor, the field size shall not open automatically to the size of the selected portion of the image receptor unless the operator has selected that mode of operation. (21CFR1020.31(h)(1))

5.4.3.2 Neither the length nor width of the X-ray field in the plane of the image receptor shall differ from the corresponding dimensions of the selected portion of the image receptor by more than 3% of the SID when adjusted for full coverage of the selected portion of the image receptor. The sum, without regard to sign, of the length and width differences shall not exceed 4% of the SID. On spot-film devices manufactured after February 25, 1978, if the angle between the plane of the image receptor and beam axis is variable, means shall be provided to indicate when the axis of the X-ray beam is perpendicular to the plane of the image receptor, and compliance shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor. (21CFR1020.31(h)(2))

5.4.3.3 The center of the X-ray field in the plane of the image receptor shall be aligned with the center of the selected portion of the image receptor to within 2% of the SID. (21CFR1020.31(h)(3))

5.4.3.4 Means shall be provided to reduce the X-ray field size in the plane of the image receptor to a size smaller than the selected portion of the image receptor such that: (21CFR1020.31(h)(4))

5.4.3.4.1 For spot-film devices used on fixed-SID fluoroscopic systems which are not required to, and do not provide stepless adjustment of the X-ray field, the minimum field size, at the greatest SID, does not exceed 125 cm2; or (21CFR1020.31(h)(4)(i))

5.4.3.4.2 For spot-film devices used on fluoroscopic systems that have a variable SID and/or stepless adjustment of the field size, the minimum field size, at the greatest SID, shall be containable in a square of 5 centimeters by 5 centimeters. (21CFR1020.31(h)(4)(ii))

5.4.4 A capability may be provided for overriding the automatic x-ray field size adjustment in case of system failure. If it is so provided, a signal visible at the fluoroscopist's position shall indicate whenever the automatic X-ray field size adjustment override is engaged. Each such system failure override switch shall be clearly labeled as follows:

For X-ray Field Limitation System Failure

(21CFR1020.31(h)(5))

5.4.5 Fluoroscopy and radiography using the fluoroscopic imaging assembly with inherently circular image receptors.

5.4.5.1 For fluoroscopic equipment manufactured before June 10, 2006, other than radiation therapy simulation systems, the following applies: (21CFR 1020.32(b)(4)(i)

5.4.5.1.1 Neither the length nor width of the X-ray field in the plane of the image receptor shall exceed that of the visible area of the image receptor by more than 3% of the SID. The sum of the excess length and the excess width shall be no greater than 4% of the SID. (21CFR 1020.32(b)(4)(i)(A))

5.4.5.1.2 For rectangular X-ray fields used with circular image receptors, the error in alignment shall be determined along the length and width dimensions of the X-ray field which pass through the center of the visible area of the image receptor. (21CFR 1020.32(b)(4)(i)(B))

5.4.5.2 For fluoroscopic equipment manufactured on or after June 10, 2006, other than radiation simulation systems, the maximum area of the X-ray field in the plane of the image receptor shall conform with one of the following requirements: (21CFR 1020.32(b)(4)(ii))

5.4.5.2.1 When any linear dimension of the visible area of the image receptor measured through the center of the visible area is less than or equal to 34 centimeters in any direction, at least 80% of the area of the X-ray field overlaps the visible area of the image receptor, or (21CFR 1020.32(b)(4)(ii)(A))

5.4.5.2.2 When any linear dimension of the visible area of the image receptor measured through the center of the visible area is greater than 34 centimeters in any direction, the X-ray field measured along the direction of greatest misalignment with the visible area of the image receptor does not extend beyond the edge of the visible area of the image receptor by more than 2 centimeters. (21CFR 1020.32(b)(4)(ii)(B))

5.4.6 Fluoroscopy and radiography using fluoroscopic imaging assembly with inherently rectangular image receptors. For X-ray systems manufactured on or after June 10, 2006, the following applies: (21CFR1020.32(b)(5))

5.4.6.1 Neither the length nor width of the X-ray field in the plane of the image receptor shall exceed that of the visible area of the image receptor by more than 3% of the SID. The sum of the excess length and the excess width shall be no greater than 4% of the SID. (21CFR1020.32(b)(5)(i))

5.4.6.2 The error in alignment shall be determined along the length and width dimensions of the X-ray field which pass through the center of the visible area of the image receptor. (21CFR1020.32(b)(5)(ii))

5.4.7 Override capability. If the fluoroscopic X-ray field size is adjusted automatically as the SID or image receptor size is changed, a capability may be provided for overriding the automatic adjustment in case of system failure. If it is so provided, a signal visible at the fluoroscopist's position shall indicate whenever the automatic field adjustment is overridden. Each such system failure override switch shall be clearly labeled as follows:

FOR X-RAY FIELD

LIMITATION SYSTEM FAILURE

(21CFR 1020.32(b)(6))

5.5 Activation of Tube. X-ray production in the fluoroscopic mode shall be controlled by a device which requires continuous pressure by the operator for the entire time of any exposure. When recording serial radiographic images from the fluoroscopic image receptor, the operator shall be able to terminate the X-ray exposure(s) at any time, but means may be provided to permit completion of any single exposure of the series in process. (21CFR 1020.32(c))

5.6 Air Kerma Rates. For fluoroscopic equipment, the following requirements apply:

5.6.1 Fluoroscopic equipment manufactured before May 19, 1995.

5.6.1.1 Equipment provided with automatic exposure rate control (AERC) shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 88 mGy per minute (vice 10 R/min exposure rate) at the measurement point specified in Part F, subsection 5.6.4 except as specified in Part F, subsection 5.6.1.5. (21CFR 1020.32(d)(1)(i))

5.6.1.2 Equipment provided without AERC shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 44 mGy per minute (vice 5 R/min exposure rate) at the measurement point specified in Part F, subsection 5.6.5, except as specified in Part F, subsection 5.6.1.5. (21CFR 1020.32(d)(1)(ii))

5.6.1.3 Equipment provided with both an AERC mode and a manual mode shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 88 mGy per minute (vice 10 R/min exposure rate) in either mode at the measurement point specified in Part F, subsection 5.6.4, except as specified in Part F, subsection 5.6.2.3 (21CFR 1020.32(d)(1)(iii))

5.6.1.4 Equipment may be modified in accordance with this Part to comply with Part F, subsection 5.6.2. When the equipment is modified, it shall bear a label indicating the date of the modification and the statement:

MODIFIED TO COMPLY WITH 21 CFR 1020.32(H)(2)

(21CFR 1020.32(d)(1)(iv))

5.6.1.5 Exceptions: During recording of fluoroscopic images.

5.6.2 Fluoroscopic equipment manufactured on or after May 19, 1995:

5.6.2.1 Shall be equipped with AERC if operable at any combination of tube potential and current that results in an AKR greater than 44 mGy per minute (vice 5 R/min exposure rate) at the measurement point specified in Part F, subsection 5.6.4. Provision for manual selection of technique factors may be provided. (21CFR 1020.32(d)(2)(i))

5.6.2.2 Shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 88 mGy per minute (vice 10 R/min exposure rate) at the measurement point specified in Part F, subsection 5.6.4, except as specified in Part F subsection 5.6.2.3. (21CFR 1020.32(d)(2)(ii))

5.6.2.3 Exceptions:

5.6.2.3.1 For equipment manufactured prior to June 10, 2006, during the recording of images from a fluoroscopic image receptor using photographic film or a video camera when the X-ray source is operated in a pulsed mode. (21CFR 1020.32(d)(2)(iii)(A))

5.6.2.3.2 For equipment manufactured on or after June 10, 2006, during the recording of images from the fluoroscopic image receptor for the purpose of providing the user with a recorded image(s) after termination of the exposure. Such recording does not include images resulting from a last-image-hold feature that are not recorded. (21CFR 1020.32(d)(2)(iii)(B))

5.6.3 Fluoroscopy equipment with optional high-level control. When high-level control is selected and the control is activated, in which case the equipment shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 176 mGy per minute (vice 20 R/min exposure rate) at the measurement point specified in Part F, subsection 5.6.4. Special means of activation of high-level controls shall be required. The high-level control shall be operable only when continuous manual activation is provided by the operator. A continuous signal audible to the fluoroscopist shall indicate that the high-level control is employed.

5.6.4 Measuring compliance. Compliance with this subsection shall be determined as follows:

5.6.4.1 If the source is below the X-ray table, the AKR shall be measured at 1 centimeter above the tabletop or cradle. (21CFR 1020.32(d)(3)(i))

5.6.4.2 If the source is above the X-ray table, the AKR shall be measured at 30 centimeters above the tabletop with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement. (21CFR 1020.32(d)(3)(ii))

5.6.4.3 In a C-arm type of fluoroscope, the AKR shall be measured at 30 centimeters from the input surface of the fluoroscopic imaging assembly, with the source positioned at any available SID, provided that the end of the beam-limiting device or spacer is no closer than 30 centimeters from the input surface of the fluoroscopic imaging assembly. (21CFR 1020.32(d)(3)(iii))

5.6.4.4 In a C-arm type of fluoroscope having an SID less than 45 centimeters, the AKR shall be measured at the minimum SSD. (21CFR 1020.32(d)(3)(iv))

5.6.4.5 In a lateral type of fluoroscope, the air kerma rate shall be measured at a point 15 centimeters from the centerline of the X-ray table and in the direction of the X-ray source with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement. If the tabletop is movable, it shall be positioned as closely as possible to the lateral X-ray source, with the end of the beam-limiting device or spacer no closer than 15 centimeters to the centerline of the X-ray table. (21CFR 1020.32(d)(3)(v))

5.6.5 Exemptions. Fluoroscopic radiation therapy simulation systems are exempt from the requirements set forth in Part F, subsection, 5.6 when used for therapy simulation purposes. (21CFR 1020.32(d)(4))

5.7 Indication of potential and current. During fluoroscopy and cinefluorography, X-ray tube potential and current shall be continuously indicated. Deviation of X-ray tube potential and current from the indicated value shall not exceed the maximum deviation as stated by the manufacturer. (21CFR 1020.32(f))

5.8 Source-skin distance

5.8.1 Means shall be provided to limit the source-skin distance to not less than 38 centimeters on stationary fluoroscopes and to not less than 30 centimeters on mobile and portable fluoroscopes. In addition, for fluoroscopes intended for specific surgical or interventional applications that would be prohibited at the source-skin distances specified in this paragraph, provisions may be made for operating at shorter source-skin distances but in no case less than 20 centimeters.

5.8.2 For stationary, mobile, or portable C-arm fluoroscopic systems manufactured on or after June 10, 2006, having a maximum source-image receptor distance of less than 45 centimeters, means shall be provided to limit the source-skin distance to not less than 19 centimeters. Such systems shall be labeled for extremity use only. In addition, for those systems intended for specific surgical that would be prohibited at the source-skin distance specified in this paragraph, provisions may be made for operation at shorter source-skin distances but in no case less than 10 centimeters.

5.9 Fluoroscopic irradiation time, display, and signal

5.9.1 Fluoroscopic equipment manufactured before June 10, 2006:

5.9.1.1 Shall be provided with means to preset the cumulative irradiation time of the fluoroscopic tube. The maximum cumulative time of the timing device shall not exceed 5 minutes without resetting. A signal audible to the fluoroscopist shall indicate the completion of any preset cumulative irradiation time. Such signal shall continue to sound while X-rays are produced until the timing device is reset. Fluoroscopic equipment may be modified in accordance with 21 CFR 1020.30(q) to comply with the requirements of this paragraph. When the equipment is modified, it shall bear a label indicating the statement:

Modified to comply with 21 CFR 1020.32(h)(2)

(21CFR 1020.32(h)(1)(i))

5.9.1.2 As an alternative to the requirements of this paragraph, radiation therapy simulation systems may be provided with a means to indicate the total cumulative exposure time during which X-rays were produced, and which is capable of being reset between X-ray examinations. (21CFR 1020.32(h)(1)(ii))

5.9.2 For X-ray controls manufactured on or after June 10, 2006, there shall be provided for each fluoroscopic tube:

5.9.2.1 A display of the fluoroscopic irradiation time at the fluoroscopist's working position. This display shall function independently of the audible signal described in this subsection. The following requirements apply: (variation of 21CFR 1020.32(h)(2)(i))

5.9.2.1.1 When the X-ray tube is activated, the fluoroscopic irradiation time in minutes and tenths of minutes shall be continuously displayed and updated at least once every 6 seconds. (21CFR 1020.32(h)(2)(i)(A))

5.9.2.1.2 The fluoroscopic irradiation time shall also be displayed within 6 seconds of termination of an exposure and remain displayed until reset. (21CFR 1020.32(h)(2)(i)(B))

5.9.2.1.3 Means shall be provided to reset the display to 0 prior to the beginning of a new examination or procedure. (21CFR 1020.32(h)(2)(i)(C))

5.9.2.2 A signal audible to the fluoroscopist shall sound for each passage of 5 minutes of fluoroscopic irradiation time during an examination or procedure. The signal shall sound until manually reset or, if automatically reset, for at least 2 seconds. (21CFR 1020.32(h)(2)(ii))

5.10 Display of last-image-hold (LIH). Fluoroscopic equipment manufactured on or after June 10, 2006, shall be equipped with means to display LIH image following termination of the fluoroscopic exposure. (21CFR 1020.32(j))

5.10.1 For an LIH image obtained by retaining pretermination fluoroscopic images, if the number of images and method of combining images are selectable by the user, the selection shall be indicated prior to initiation of the fluoroscopic exposure. (21CFR 1020.32(j)(1))

5.10.2 For an LIH image obtained by initiating a separate radiographic-like exposure at the termination of fluoroscopic imaging, the technique factors for the LIH image shall be selectable prior to the fluoroscopic exposure, and the combination selected shall be indicated prior to initiation of the fluoroscopic exposure. (21CFR 1020.32(j)(2))

5.10.3 Means shall be provided to clearly indicate to the user whether a displayed image is the LIH radiograph or fluoroscopy. Display of the LIH radiograph shall be replaced by the fluoroscopic image concurrently with re-initiation of fluoroscopic exposure, unless separate displays are provided for the LIH radiograph and fluoroscopic images. (21CFR 1020.32(j)(3))

5.11 Displays of values of AKR and cumulative air kerma. Fluoroscopic equipment manufactured on or after June 10, 2006, shall display at the fluoroscopist's working position the AKR and cumulative air kerma. The following requirements apply for each X-ray tube used during an examination or procedure: (21CFR 1020.32(k))

5.11.1 When the X-ray tube is activated and the number of images produced per unit time is greater than 6 images per second, the AKR in mGy/min shall be continuously displayed and updated at least once every second. (21CFR 1020.32(k)(1))

5.11.2 The cumulative air kerma in units of mGy shall be displayed either within 5 seconds of termination of an exposure or displayed continuously and updated at least once every 5 seconds. (21CFR 1020.32(k)(2))

5.11.3 The display of the AKR shall be clearly distinguishable from the display of the cumulative air kerma. (21CFR 1020.32(k)(3))

5.11.4 The AKR and cumulative air kerma shall represent the value for conditions of free-in-air irradiation at 1 of the following reference locations specified according to the type of fluoroscope. (21CFR 1020.32(k)(4))

5.11.4.1 For fluoroscopes with X-ray source below the X-ray table, X-ray source above the table, or of lateral type, the reference location shall be the respective locations specified in Part F, subsection 5.6.4.1, 5.6.4.2 or 5.6.4.5 (21CFR 1020.32(k)(4)(i))

5.11.4.2 For C-arm fluoroscopes, the reference location shall be 15 centimeters from the isocenter toward the X-ray source along the beam axis. Alternatively, the reference location shall be at a point specified by the manufacturer to represent the location of the intersection of the X-ray beam with the patient's skin. (21CFR 1020.32(k)(4)(ii))

5.11.5 Means shall be provided to reset to 0 the display of cumulative air kerma prior to the commencement of a new examination or procedure. (21CFR 1020.32(k)(5))

5.11.6 The displayed AKR and cumulative air kerma shall not deviate from the actual values by more than ±35% over the range of 6 mGy/min and 100 mGy to the maximum indication of AKR and cumulative air kerma, respectively. Compliance shall be determined with an irradiation time greater than 3 seconds. (21CFR 1020.32(k)(6))

5.12 Protection From Scatter Radiation

5.12.1 For stationary fluoroscopic systems, ancillary shielding, such as drapes, self-supporting curtains, or viewing shields, shall be available and used as supplemental protection for all individuals other than the patient in the room during a fluoroscopy procedure.

5.12.2 Where sterile fields or special procedures prohibit the use of normal protective barriers or drapes, all of the following conditions shall be met:

5.12.2.1 Shielding required under Part F, subsection 5.12.1 shall be maintained to the degree possible under the clinical conditions.

5.12.2.2 All persons, except the patient, in the room where fluoroscopy is performed shall wear protective aprons that provide a lead equivalent shielding of at least 0.25 millimeters.

5.12.2.3 The fluoroscopic field size shall be reduced to the minimum required for the procedure being performed (area of clinical interest).

5.12.3 Operating and safety procedures shall reflect the above conditions, and fluoroscopy personnel shall exhibit awareness of situations requiring the use and/or non-use of the protective drapes.

5.13 Operator Qualifications

5.13.1 In addition to the applicable sections of these regulations, the operation of a fluoroscopic X-ray system for clinical purposes shall be limited to:

5.13.1.1 A licensed practitioner who is also a physician, or an advanced practitioner (PA or APRN) working within their professional scope of practice per Title 24 Delaware Code, or a certified radiologic technologist working within their scope of practice per these radiation control regulations.

5.13.1.2 A radiologist assistant (RA) (if recognized by the state licensing agency) working within his or her scope of practice and under the direct supervision of a licensed practitioner who is also a radiologist, meeting the conditions of Part F, subsection 5.13.1.1;

5.13.1.3 A licensed physician's assistant who passed the state-level American Registry of Radiologic Technologists (ARRT) Fluoroscopy Exam (or equivalent) and only under the direct supervision of the licensed practitioner who is also a physician, working within his or her scope of practice.

5.13.1.4 A medical resident or radiologic technology student, in training, and only under the personal supervision of the licensed practitioner who is also a physician working within their scope of practice, per Title 24 Delaware Code.

5.13.2 All persons operating, or supervising the operation of, fluoroscopy systems shall have completed training that includes but is not limited to the following:

5.13.2.1 Basic properties of radiation;

5.13.2.2 Biological effects of X-ray;

5.13.2.3 Radiation protection methods for patients and staff;

5.13.2.4 Units of measurement and dose, including DAP (dose-area product) values & air kerma;

5.13.2.5 Factors affecting fluoroscopic outputs;

5.13.2.6 High level control options;

5.13.2.7 Dose management including dose reduction techniques, monitoring, and recording;

5.13.2.8 Principles and operation of the specific fluoroscopic X-ray system(s) to be used;

5.13.2.9 Fluoroscopic and fluorographic outputs of each mode of operation on the system(s) to be used clinically; and

5.13.2.10 Applicable requirements of these regulations.

5.13.3 All persons operating, or supervising the operation of, fluoroscopy systems during Fluoroscopically Guided Interventional (FGI) procedures shall have completed training that includes but is not limited to:

5.13.3.1 The topics provided in Part F, subsection 5.13.2;

5.13.3.2 Methods to reduce patient dose using advanced imaging and recording features;

5.13.3.3 Procedures for recording pertinent data specified in Part F, subsection 5.16; and

5.13.3.4 Documentation pertaining to the requirements of Part F, Section 5.0 shall be maintained for review for 3 years.

5.14 Equipment Operation

5.14.1 All fluoroscopic images shall be viewed, directly or indirectly, and interpreted by a licensed practitioner who is also a physician or an advanced practitioner (PA or APRN) working within their professional scope of practice, per Title 24 Delaware Code.

5.14.2 Overhead fluoroscopy shall not be used as a positioning tool for general purpose radiographic examinations.

5.14.3 Operators shall be competent in the standard operating procedures of the unit in use, including the use of available dose-saving features, and the relative radiation output rates of the various modes of operation.

5.14.4 Procedure planning for fluoroscopic procedures on pregnant patients shall include feasible modifications to minimize the dose to the conceptus.

5.14.5 Procedure planning for fluoroscopic procedures on pediatric patients shall include feasible modifications to minimize dose.

5.14.6 The registrant shall use all methods available on the fluoroscopy system to monitor dose during a fluoroscopic procedure.

5.14.7 The facility shall establish a written policy regarding patient dose management in fluoroscopically guided procedures in conformance with the ACR-AAPM Technical Standard for Management of the Use of Radiation in Fluoroscopic Procedures (ACR Resolution 44 - 2013), NCRP Report 168, or equivalent.

5.15 Qualified Medical Physicist Evaluations

5.15.1 Fluoroscopic equipment shall be evaluated by a QMP or authorized staff under the general direction of a QMP; within 30 days of installation. Any maintenance of the system that may affect the exposure rate shall be evaluated by a QMP, or internally authorized staff under the general direction of a QMP. Thereafter, the measurements shall be made of fluoroscopic equipment annually. At a minimum these evaluations shall include:

5.15.1.1 A measurement of entrance exposure rates that covers the full range of patient thicknesses, including those that are expected to drive the system to maximum output in all modes clinically used, including fluoroscopy, high-level control, acquisition, digital subtraction and Cineradiography, when available. These measurements shall:

5.15.1.1.1 For systems without automatic exposure control, be made utilizing a milliamperage and kVp typical of the clinical use of the fluoroscopic system;

5.15.1.1.2 For systems with automatic exposure control, be made utilizing sufficient attenuating material in the useful beam to produce a milliamperage and kVp typical of the clinical use of the fluoroscopic system;

5.15.1.2 A measurement and verification of compliance of maximum AKR for fluoroscopy and high-level control, if available. Measurements shall be made in accordance with Part F, subsection 5.6.4.

5.15.1.3 An evaluation of high contrast resolution and low contrast resolution in both fluoroscopic and spot-film modes.

5.15.1.4 An evaluation of the operation of the 5-minute timer, warning lights, interlocks, and collision sensors.

5.15.1.5 An evaluation of the beam quality and collimation in the fluoroscopy and spot-film modes.

5.15.1.6 An evaluation of the availability and accuracy of technique indicators and integrated radiation dose displays.

5.15.1.7 An evaluation of any changes that may impact patient and personnel protection devices.

5.15.2 Measurements required in Part F, subsection 5.15.1 shall be performed with a calibrated dosimetry system per manufacturer recommendations not to exceed 2 years and records maintained for 5 years for inspection by the Agency.

5.16 Additional requirements for facilities performing fluoroscopically-guided interventional (FGI) procedures

5.16.1 A registrant utilizing FGI procedures shall establish a Radiation Protocol Committee (RPC) in accordance with the following:

5.16.1.1 The registrant may establish a system-wide committee if the registrant has more than 1 site.

5.16.1.2 Two or more registrants may form a cooperative RPC as long as each facility has a representative on the committee.

5.16.1.3 If the registrant has already established a radiation safety committee, the requirements of this subsection may be delegated to that committee if the members meet the requirements of Part F, subsection 5.16.5.

5.16.2 A quorum of the RPC shall meet as often as necessary, but at intervals not to exceed 12 months.

5.16.3 Record of RPC. A record of each RPC meeting shall include the date, names of individuals in attendance, minutes of the meeting, and any actions taken. The registrant shall maintain RPC meeting record for inspection by the Agency for at least 3 years.

5.16.4 Provide an annual report to the radiation safety committee, or to the radiation safety officer.

5.16.5 RPC Members. Members shall include but not be limited to the following individuals:

5.16.5.1 A supervising licensed practitioner of the healing arts who meets the requirements in Part F, subsection 5.13;

5.16.5.2 A QMP or QE;

5.16.5.3 A radiologic technologist; and

5.16.5.4 Other individuals as deemed necessary by the registrant. (eg. RSO, Chief Medical or Administrative Officer, Radiology Department Administrator/Manager)

5.16.6 Establish and implement FGI procedure protocols

5.16.6.1 The RPC shall establish and implement written protocols, or protocols documented in an electronic report system, that include but are not limited to the following:

5.16.6.1.1 A method to be used to monitor patient radiation dose during FGI.

5.16.6.1.2 Dose notification levels, as appropriate, at which the physician is notified and appropriate actions are taken for patient safety.

5.16.6.1.3 Substantial Radiation Dose Level (SRDL) values following nationally recognized standards,

5.16.6.1.4 Actions to be taken for cases when a SRDL is exceeded which may include patient follow-up.

5.16.6.1.5 A review of the established protocols at an interval not to exceed 12 months.

5.16.6.2 A record of each RPC protocol shall be maintained for inspection by the Agency.

5.16.7 Procedures for maintaining records.

5.16.7.1 A record of radiation output information shall be maintained so the radiation dose to the skin may be estimated in accordance with established protocols. The record shall include the following:

5.16.7.1.1 Patient identification;

5.16.7.1.2 Type and date of examination;

5.16.7.1.3 Identification of the fluoroscopic system used; and

5.16.7.1.4 Peak skin dose, cumulative air kerma or dose area product used if the information is available on the fluoroscopic system.

5.16.7.1.5 If the peak skin dose, cumulative air kerma or dose area product are not displayed on the fluoroscopic system, records shall include other information necessary to estimate the radiation dose to the skin in accordance with established protocol or the following as necessary:

5.16.7.1.5.1 Fluoroscopic mode, such as, high-level or pulsed mode of operation;

5.16.7.1.5.2 Cumulative fluoroscopic exposure time; and

5.16.7.1.5.3 Number of films or recorded exposures.

5.16.7.2 The registrant shall maintain records required by this subparagraph for inspection by the Agency.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-6.0** Radiographic Equipment {#sec-4465-6.0 omnilex-key=us-de-regs-official--title-16--4465-6.0}

6.1 The following regulations apply to all non-dental registrants using diagnostic x-ray equipment. Requirements specific to using dental intra-oral, hand held, panoramic, and cephalometric equipment are in Part F, Section 7.0.

6.2 Digital radiographic systems shall be evaluated by a QMP (QE) prior to clinical use, and at least annually. The evaluation shall follow nationally recognized standards or procedures. Unless otherwise specified in this Part, dental, podiatric, and veterinary systems are exempt from this requirement.

6.3 Control and indication of technique factors.

6.3.1 Timers. Means shall be provided to terminate the exposure at a preset time interval, a preset product of current and time, a preset number of pulses, or a preset radiation exposure to the image receptor. (21CFR1020.31(a)(2))

6.3.1.1 Except during serial radiography, the operator shall be able to terminate the exposure at any time during an exposure of greater than 1/2 second. Except during panoramic dental radiography, termination of exposure shall cause automatic resetting of the timer to its initial setting or to 0. It shall not be possible to make an exposure when the timer is set to a 0 or off position if either position is provided. (21CFR1020.31(a)(2)(i))

6.3.1.2 During serial radiography, the operator shall be able to terminate the X-ray exposure(s) at any time, but means may be provided to permit completion of any single exposure of the series in process. (21CFR1020.31(a)(2)(ii))

6.3.2 Automatic exposure controls. When an automatic exposure control is provided:

6.3.2.1 Indication shall be made on the control panel when this mode of operation is selected; (21CFR1020.31(a)(3)(i))

6.3.2.2 When the X-ray tube potential is equal to or greater than 51 kilovolts peak (kVp), the minimum exposure time for field emission equipment rated for pulse operation shall be equal to or less than a time interval equivalent to 2 pulses and the minimum exposure time for all other equipment shall be equal to or less than 1/60 second or a time interval required to deliver 5 milliampere-seconds (mAs), whichever is greater; (21CFR1020.31(a)(3)(ii))

6.3.2.3 Either the product of peak X-ray tube potential, current, and exposure time shall be limited to not more than 60 kilowatt-seconds (kWs) per exposure or the product of X-ray tube current and exposure time shall be limited to not more than 600 mAs per exposure, except when the X-ray tube potential is less than 51 kVp, in which case the product of X-ray tube current and exposure time shall be limited to not more than 2,000 mAs per exposure; and (21CFR1020.31(a)(3)(iii))

6.3.2.4 A visible signal shall indicate when an exposure has been terminated at the limits described in Part F, subsection 6.3.2.3, and manual resetting shall be required before further automatically timed exposures can be made. (21CFR1020.31(a)(3)(iv))

6.3.3 Accuracy. Deviation of technique factors under Part F, subsection 6.3 from indicated values shall not exceed the limits given by the manufacturer. (variation of 21CFR1020.31(a)(4))

6.4 Reproducibility

6.4.1 Coefficient of variation. For any specific combination of selected technique factors, the estimated coefficient of variation of the air kerma shall be no greater than 0.05. (21CFR1020.31(b)(1)

6.4.2 Measuring compliance. Determination of compliance shall be based on 10 consecutive measurements taken within a time period of 1 hour. Equipment manufactured after September 5, 1978, shall be subject to the additional requirement that all variable controls for technique factors shall be adjusted to alternate settings and reset to the test setting after each measurement. The percent line-voltage regulation shall be within ±1 of the mean value for all measurements. For equipment having automatic exposure controls, compliance shall be determined with a sufficient thickness of attenuating material in the useful beam such that the technique factors can be adjusted to provide individual exposures of a minimum of 12 pulses on field emission equipment rated for pulsed operation or no less than 1/10 second per exposure on all other equipment. (21CFR1020.31(b)(2))

6.5 Linearity. The following requirements apply for any fixed X-ray tube potential within the range of 40% to 100% of the maximum rated. (variation of 21CFR1020.31(c))

6.5.1 Equipment having independent selection of X-ray tube current (mA). The average ratios of air kerma to the indicated milliampere-seconds product (mGy/mAs) obtained at any 2 consecutive tube current settings shall not differ by more than 0.10 times their sum. This is: ׀X1 – X2׀ ≤ 0.10(X1 + X2); where X1 and X2 are the average mGy/mAs values obtained at each of 2 consecutive mAs selector settings or at 2 settings differing by no more than a factor of 2 where the mAs selector provides continuous selection. (21CFR1020.31(c)(1))

6.5.2 Equipment having selection of X-ray tube current-exposure time product (mAs). For equipment manufactured after May 3, 1994, the average ratios of air kerma to the indicated milliampere-seconds product (mGy/mAs) obtained at any 2 consecutive mAs selector settings shall not differ by more than 0.10 times their sum. This is: ׀X1 – X2׀ ≤ 0.10(X1 + X2); where X1 and X2 are the average mGy/mAs values obtained at each of 2 consecutive mAs selector settings or at 2 settings differing by no more than a factor of 2 where the mAs selector provides continuous selection. (21CFR1020.31(c)(2))

6.5.3 Measuring compliance. Determination of compliance will be based on 10 exposures, made within 1 hour, at each of the 2 settings. These 2 settings may include any 2 focal spot sizes except where 1 is equal to or less than 0.45 millimeters and the other is greater than 0.45 millimeters. For purposes of this requirement, focal spot size is the focal spot size specified by the X-ray tube manufacturer. The percent line-voltage regulation shall be determined for each measurement. All values for percent line-voltage regulation at any 1 combination of technique factors shall be within ±1 of the mean value for all measurements at these technique factors. (21CFR1020.31(c)(3))

6.6 Field limitation and alignment for mobile, portable, and stationary general purpose X-ray systems. Except when spot-film devices are in service, mobile, portable, and stationary general purpose radiographic X-ray systems shall meet the following requirements: (21CFR1020.31(d))

6.6.1 Variable X-ray field limitation. A means for stepless adjustment of the size of the X-ray field shall be provided. Each dimension of the minimum field size at an SID of 100 centimeters shall be equal to or less than 5 centimeters. (21CFR1020.31(d)(1))

6.6.2 Visual definition

6.6.2.1 Means for visually defining the perimeter of the X-ray field shall be provided. The total misalignment of the edges of the visually defined field with the respective edges of the X-ray field along either the length or width of the visually defined field shall not exceed 2% of the distance from the source to the center of the visually defined field when the surface upon which it appears is perpendicular to the axis of the X-ray beam. (21CFR1020.31(d)(2)(i))

6.6.2.2 When a light localizer is used to define the X-ray field, it shall provide an average illuminance of not less than 160 lux (15 footcandles) at 100 centimeters or at the maximum SID, whichever is less. The average illuminance shall be based on measurements made in the approximate center of each quadrant of the light field. Radiation therapy simulation systems are exempt from this requirement. (21CFR1020.31(d)(2)(ii))

6.6.2.3 The edge of the light field at 100 centimeters or at the maximum SID, whichever is less, shall have a contrast ratio, corrected for ambient lighting, of not less than 4 in the case of beam-limiting devices designed for use on stationary equipment, and a contrast ratio of not less than 3 in the case of beam-limiting devices designed for use on mobile and portable equipment. The contrast ratio is defined as I1/I2, where I1 is the illuminance 3 millimeters from the edge of the light field toward the center of the field; and I2 is the illuminance 3 millimeters from the edge of the light field away from the center of the field. Compliance shall be determined with a measuring aperture of 1 millimeters. (21CFR1020.31(d)(2)(iii))

6.7 Field indication and alignment on stationary general purpose X-ray equipment. Except when spot-film devices are in service, stationary general purpose X-ray systems shall meet the following requirements in addition to those prescribed in Part F, subsection 6.6: (21CFR1020.31(e))

6.7.1 Means shall be provided to indicate when the axis of the X-ray beam is perpendicular to the plane of the image receptor, to align the center of the X-ray field with respect to the center of the image receptor to within 2% of the SID, and to indicate the SID to within 2%; (21CFR1020.31(e)(1))

6.7.2 The beam-limiting device shall numerically indicate the field size in the plane of the image receptor to which it is adjusted; (21CFR1020.31(e)(2))

6.7.3 Indication of field size dimensions and SIDs shall be specified in centimeters and/or inches and shall be such that aperture adjustments result in X-ray field dimensions in the plane of the image receptor which correspond to those indicated by the beam-limiting device to within 2% of the SID when the beam axis is indicated to be perpendicular to the plane of the image receptor; and (21CFR1020.31(e)(3))

6.7.4 Compliance measurements will be made at discrete SIDs and image receptor dimensions in common clinical use (such as SIDs of 100, 150, and 200 centimeters and/or 36, 40, 48, 72 inches and nominal image receptor dimensions of 13, 18, 24, 30, 35, 40, and 43 centimeters and/or 5, 7, 8, 9, 10, 11, 12, 14, and 17 inches) or at any other specific dimensions at which the beam-limiting device or its associated diagnostic X-ray system is uniquely designed to operate. (21CFR1020.31(e)(4))

6.8 Field limitation on X-ray equipment other than general purpose radiographic systems.

6.8.1 X-ray systems designed for 1 image receptor size. Radiographic equipment designed for only 1 image receptor size at a fixed SID shall be provided with means to limit the field at the plane of the image receptor to dimensions no greater than those of the image receptor, and to align the center of the X-ray field with the center of image receptor to within 2% of the SID, or shall be provided with means to both size and align the X-ray field such that the X-ray field at the plane of the image receptor does not extend beyond the edge of the image receptor.

6.8.2 Other X-ray systems. Radiographic systems not specifically covered in Part F, subsection 6.6, subsection 6.8.2, subsection 6.8.3, and systems covered in Part F, subsection 6.8.1, which are also designed for use with extraoral image receptors and when used with an extraoral image receptor, shall be provided with means to limit the X-ray field in the plane of the image receptor so that such field does not exceed each dimension of the image receptor by more than 2% of the SID, when the axis of the X-ray beam is perpendicular to the plane of the image receptor. In addition, means shall be provided to align the center of the X-ray field with the center of the image receptor to within 2% of the SID, or means shall be provided to both size and alignment the X-ray field such that the X-ray field at the plane of the image receptor does not extend beyond any edge of the image receptor. These requirements may be met with: (21CFR1020.31(f)(4))

6.8.2.1 A system which performs in accordance with Part F, subsection 6.6 and Part F, subsection 6.7; or when alignment means are also provided, may be met with either; (21CFR1020.31(f)(4)(i))

6.8.2.2 An assortment of removable, fixed-aperture, beam-limiting devices sufficient to meet the requirement for each combination of image receptor size and SID for which the unit is designed. Each such device shall have clear and permanent markings to indicate the image receptor size and SID for which it is designed; or (21CFR1020.31(f)(4)(ii))

6.8.2.3 A beam-limiting device having multiple fixed apertures sufficient to meet the requirement for each combination of image receptor size and SID for which the unit is designed. Permanent, clearly legible markings shall indicate the image receptor size and SID for which each aperture is designed and shall indicate which aperture is in position for use. (21CFR1020.31(f)(4)(iii))

6.9 Positive beam limitation (PBL). The requirements of this subsection shall apply to radiographic systems which contain PBL. (21CFR1020.31(g))

6.9.1 Field size. When a PBL system is provided, it shall prevent X-ray production when: (21CFR1020.31(g)(1))

6.9.1.1 Either the length or width of the X-ray field in the plane of the image receptor differs from the corresponding image receptor dimension by more than 3% of the SID; or (21CFR1020.31(g)(1)(i))

6.9.1.2 The sum of the length and width differences stated in Part F, subsection 6.9.1.1 without regard to sign exceeds 4% of the SID. (21CFR1020.31(g)(1)(ii))

6.9.1.3 The beam-limiting device is at an SID for which PBL is not designed for sizing. (21CFR1020.31(g)(1)(iii))

6.9.2 Conditions for Positive Beam Limitation (PBL). When provided, the PBL system shall function as described in Part F, subsection 6.9.1 whenever all the following conditions are met: (21CFR1020.31(g)(2))

6.9.2.1 The image receptor is inserted into a permanently mounted cassette holder; (21CFR1020.31(g)(2)(i))

6.9.2.2 The image receptor length and width are less than 50 centimeters; (21CFR1020.31(g)(2)(ii))

6.9.2.3 The X-ray beam axis is within ±3 degrees of vertical and the SID is 90 centimeters to 130 centimeters inclusive; or the X-ray beam axis is within ±3 degrees of horizontal and the SID is 90 centimeters to 205 centimeters inclusive; (21CFR1020.31(g)(2)(iii))

6.9.2.4 The X-ray beam axis is perpendicular to the plane of the image receptor to within ±3 degrees; and (21CFR1020.31(g)(2)(iv))

6.9.2.5 Neither tomographic nor stereoscopic radiography is being performed. (21CFR1020.31(g)(2)(v))

6.9.3 Measuring compliance. Compliance with the requirements of Part F, subsection 6.9.1 shall be determined when the equipment indicates that the beam axis is perpendicular to the plane of the image receptor and the provisions of Part F, subsection 6.9.2 are met. Compliance shall be determined no sooner than 5 second after insertion of the image receptor. (21CFR1020.31(g)(3))

6.9.4 Operator initiated undersizing. The PBL system shall be capable of operating such that, at the discretion of the operator, the size of the field may be made smaller than the size of the image receptor through stepless adjustment of the field size. Each dimension of the minimum field size at an SID of 100 centimeters shall be equal to or less than 5 centimeters. Return to PBL function as described in Part F, subsection 6.9.1 shall occur automatically upon any change of image receptor size or SID. (21CFR1020.31(g)(4))

6.9.5 Override of PBL. A capability may be provided for overriding PBL in case of system failure and for servicing the system. This override may be for all SIDs and image receptor sizes. A key shall be required for any override capability that is accessible to the operator. It shall not be possible to remove the key while PBL is overridden. Each such key switch or key shall be clearly and durably labeled as follows:

For X-Ray Field Limitation System Failure

The override capability is considered accessible to the operator if it is referenced in the operator's manual or in other material intended for the operator or if its location is such that the operator would consider it part of the operational controls. (21CFR1020.31(g)(5))

6.9.6 Disabling of PBL. A facility has the option to permanently functionally disable a PBL system. When this option is chosen, the standards for manual collimation apply.

6.10 Source-skin distance. The minimum source-skin distance shall not be less than 30 centimeters, except intraoral dental equipment covered under Part F, subsection 7.17.2 and veterinary equipment.

6.11 Radiation from capacitor energy storage equipment. Radiation emitted from the X-ray tube shall not exceed: (21CFR1020.31(l))

6.11.1 An air kerma of 0.26 microGy (vice 0.03 mR exposure) in 1 minute at 5 centimeters from any accessible surface of the diagnostic source assembly, with the beam-limiting device fully open, the system fully charged, and the exposure switch, timer, or any discharge mechanism not activated. Compliance shall be determined by measurements averaged over an area of 100 cm2, with no linear dimensions greater than 20 centimeters; and(21CFR1020.31(l)(1))

6.11.2 An air kerma of 0.88 mGy (vice 100 mR exposure) in 1 hour at 100 centimeters from the X-ray source, with beam-limiting device fully open, when the system is discharged through the X-ray tube either manually or automatically by use of a discharge switch or deactivation of the input power. Compliance shall be determined by measurements of the maximum air kerma per discharge multiplied by the total number of discharges in 1 hour (duty cycle). The measurements shall be averaged over an area of 100 cm2 with no linear dimension greater than 20 centimeters. (21CFR1020.31(l)(2))

6.12 Radiation Exposure Control

6.12.1 Exposure Initiation. Means shall be provided to initiate the radiation exposure by a deliberate action on the part of the operator, such as the depression of a switch. Radiation exposure shall not be initiated without such an action. In addition, it shall not be possible to initiate an exposure when the timer is set to a "0" or "off" position if either position is provided.

6.12.2 Exposure Indication. Means shall be provided for visual indication observable at or from the operator's protected position whenever X-rays are produced. In addition, a signal audible to the operator shall indicate that the exposure has terminated.

6.12.3 Operator Protection, Except Veterinary Systems

6.12.3.1 Stationary Radiographic Systems. Stationary radiographic systems shall be required to have the X-ray control, including the exposure switch, permanently mounted in a protected area so that the operator is required to remain in that protected area during the entire exposure.

6.12.3.2 Mobile and Portable Systems. Mobile and portable X-ray systems which are:

6.12.3.2.1 Used continuously for greater than 1 week in the same location, i.e., a room or suite, shall meet the requirements of Part F, subsection 6.12.3.1;

6.12.3.2.2 Used for less than 1 week at the same location shall be provided with either a protective barrier at least 2 meters (6.5 feet) high for operator protection during exposures, or means shall be provided to allow the operator to be at least 2.7 meters (9 feet) from the tube housing assembly during the exposure.

6.12.3.2.3 Podiatry Systems. Podiatry facilities shall meet the protection requirements in Part F, subsection 6.12.3.2.2.

6.12.4 Operator and Ancillary Personnel Protection for Veterinary Systems. All stationary, mobile or portable X-ray systems used for veterinary work shall be provided with either a 2 meter (6.5 feet) high protective barrier for operator protection during exposures, or shall be provided with means to allow the operator to be at least 2 meters (6.5 feet) from the tube housing assembly during exposures. Otherwise, in cases where animals are held, the operator and ancillary personnel shall be protected by a minimum of 0.25 millimeters lead equivalent from scatter radiation and 0.5 millimeters from the useful beam. Refer to Part F, Section 7.0 for hand-held intraoral dental X-ray units used in veterinary practice.

6.13 Tube Stands for Portable X-Ray Systems. Except during veterinary field operations where it is impractical to do so, a tube stand or other mechanical support shall be used for portable X-ray systems, so that the X-ray tube housing assembly need not be hand-held during an exposure.

6.14 Systems designed for mammography. All systems designed for mammography shall comply with Mammography Quality Standards Act of 1998.

6.15 Prohibitions. Capacity energy storage equipment shall not be used to image humans 2 years after the effective date of this Part.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-7.0** Dental Facilities {#sec-4465-7.0 omnilex-key=us-de-regs-official--title-16--4465-7.0}

7.1 In addition to the applicable provisions of Part F, Section 3.0, the requirements of Part F, Section 7.0 apply to dental facilities using intraoral, panoramic, and cephalometric x-ray equipment. Dental facilities using cone beam computed tomography (CBCT) technology shall follow applicable provisions of Part F, subsection 11.8.

7.2 Quality Assurance. In addition to the general quality assurance provisions in Part F, Section 3.0, the following requirements apply to a dental facility:

7.2.1 If using film, maintain a light-tight darkroom, use proper safelighting and safeguards, and evaluate darkroom integrity and daylight loading systems for film fog every 6 months and after a change that may impact film fog.

7.2.2 If using a filmless system, maintain and operate PSP and DDR systems according to manufacturer specifications.

7.2.3 Registrant shall provide initial orientation to X-ray operators to include but not limited to: positioning of the X-ray tube, image processing, operator location during X-ray exposure, source to skin distance, radiation protection, appropriate radiographic protocol, and applicable regulatory requirements. Records of training shall be maintained for inspection by the Agency.

7.3 Warning Label

7.3.1 On systems manufactured on or before June 10, 2006, the control panel containing the main power switch shall bear the warning statement or the warning statement in Part F, subsection 7.3.2, legible and accessible to view: "WARNING: This X-ray unit may be dangerous to patient and operator unless safe exposure factors, operating instructions are observed."

7.3.2 On systems manufactured after June 10, 2006, the control panel containing the main power switch shall bear the warning statement, legible and accessible to view: "WARNING: This X-ray unit may be dangerous to patient and operator unless safe exposure factors, operating instructions and maintenance schedules are observed."

7.4 Radiation Exposure Control. Means shall be provided to initiate the radiation exposure by a deliberate action on the part of the operator, such as the depression of a switch. Radiation exposure shall not be initiated without such an action.

7.5 Exposure Control Location and Operator Protection. Except for units designed to be hand-held, the exposure control shall allow the operator to be:

7.5.1 Behind a protective barrier at least 2 meters (6.5 feet) tall; or

7.5.2 At least 2 meters (6.5 feet) from the tube housing assembly, outside the path of the useful x-ray beam, while making exposures.

7.6 Administrative Controls

7.6.1 Patient and image receptor holding devices shall be used when the techniques permit.

7.6.2 Except for units designed to be hand-held, the tube housing and position indicating device (PID) shall not be hand-held during an exposure.

7.6.3 Dental fluoroscopy without image intensification shall not be used.

7.7 Hand-Held Intraoral Equipment. In addition to the standards in this chapter, the following applies specifically to hand-held devices:

7.7.1 The hand-held X-ray system shall be equipped with a backscatter shield of not less than 0.25 millimeters lead equivalent and 15.2 centimeters (6 inches) in diameter that is positioned as close as practicable to the distal end of the position indication device.

7.7.2 The facility shall maintain documentation that each operator has completed training as specified by the manufacturer, and approved by the Agency.

7.7.3 The facility shall adopt and follow protocols provided by the manufacturer, and approved by the agency, regarding the safe operation of the device.

7.7.4 When operating a hand-held intraoral dental radiographic unit, operators shall wear a 0.25 millimeters lead equivalent apron, unless otherwise authorized by the Agency or a certified health or qualified medical physicist.

7.7.5 If the operator has difficulty in holding the device stationary during the exposure, the operator shall use a stand to immobilize the device.

7.7.6 The registrant shall secure the hand-held device from unauthorized removal or use, and report any lost or stolen device to the Agency within 24 hours of discovery.

7.7.7 The registrant shall maintain a Usage Log listing every procedure performed on a patient, to include user name, date, time of use. Usage Log shall be available for inspection by the Agency.

7.8 Beam-on indicators. The X-ray control shall provide visual indication whenever X-rays are produced. In addition, a signal audible to the operator shall indicate that the exposure has terminated. (21CFR1020.31(j))

7.9 Multiple Tubes. Where 2 or more radiographic tubes are controlled by 1 exposure switch, the tube which has been selected shall be clearly indicated prior to initiation of the exposure. Only the selected tube can be energized. This indication shall be both on the X-ray control panel and at or near the tube housing assembly which has been selected. (21CFR1020.31(k))

7.10 Mechanical Support of Tube Head. The tube housing assembly supports shall be adjusted such that the tube housing assembly will remain stable during an exposure unless tube housing movement is a designed function of the X-ray system.

7.11 Battery charge indicator. On battery-powered generators, visual means shall be provided on the control panel to indicate whether the battery is in a state of charge adequate for proper operation. (21CFR1020.30(o))

7.12 Locks. All position locking, holding, and centering devices on X-ray system components and systems shall function as intended.

7.13 Technique Indicators

7.13.1 For X-ray equipment capable of displaying technique factors, the technique factors to be used during an exposure shall be indicated before the exposure begins. If automatic exposure controls are used, the technique factors which are set prior to the exposure shall be indicated. (21CFR1020.31(a)(1))

7.13.2 The requirement of Part F, subsection 7.12.1 may be met by permanent markings on equipment having fixed technique factors. (21CFR1020.31(a)(1))

7.14 Exposure Reproducibility. For any specific combination of selected technique factors, the estimated coefficient of variation of the air kerma shall be no greater than 0.05. (21CFR1020.31(b)(1))

7.15 Timers. Means shall be provided to terminate the exposure at a preset time interval, a preset product of current and time, a preset number of pulses, or a preset radiation exposure to the image receptor. (21CFR1020.31(a)(2))

7.16 Kilovolt Peak. Deviation of technique factors from indicated values shall not exceed the limits provided by the manufacturer. (variation of 21CFR1020.31(a)(4)) At a minimum, the kVp on variable kVp units shall be accurate to within 10% and within 20% on fixed kVp units.

7.17 X-ray Beam Alignment

7.17.1 The useful X-ray beam shall be limited to the area of clinical interest.

7.17.2 Intraoral Dental Units

7.17.2.1 X-ray systems designed for use with an intraoral image receptor shall be provided with means to limit the source-to-skin distance (SSD) to not less than 18 cm (21CFR1020.31(i)(1))

7.17.2.2 The x-ray field at the minimum SSD shall be containable in a circle having a diameter of no more than 7 cm. (21CFR1020.31(f)(1)(i))

7.17.3 Extraoral, Panoramic and Cephalometric Units. X-ray systems designed for use with extraoral image receptors and when used with an extraoral image receptor, shall be provided with means to limit the X-ray field in the plane of the image receptor so that such field does not exceed each dimension of the image receptor by more than 2% of the SID, when the axis of the X-ray beam is perpendicular to the plane of the image receptor. In addition, means shall be provided to align the center of the X-ray field with the center of the image receptor to within 2% of the SID, or means shall be provided to both size and alignment the X-ray field such that the X-ray field at the plane of the image receptor does not extend beyond any edge of the image receptor. These requirements may be met with: (21CFR1020.31(f)(4))

7.17.3.1 An assortment of removable, fixed-aperture, beam-limiting devices sufficient to meet the requirement for each combination of image receptor size and SID for which the unit is designed. Each such device shall have clear and permanent markings to indicate the image receptor size and SID for which it is designed; or (21CFR1020.31(f)(4)(ii))

7.17.3.2 A beam-limiting device having multiple fixed apertures sufficient to meet the requirement for each combination of image receptor size and SID for which the unit is designed. Permanent, clearly legible markings shall indicate the image receptor size and SID for which each aperture is designed and shall indicate which aperture is in position for use. (21CFR1020.31(f)(4)(iii))

7.18 Beam Quality. The Half Value Layer (HVL) of the useful beam for a given X-ray tube potential shall not be less than the values shown in Table 1. If it is necessary to determine such half-value layer at an X-ray tube potential which is not listed in Table 1 of this section, linear interpolation or extrapolation may be made. Positive means shall be provided to ensure that at least the minimum filtration needed to achieve beam quality requirements is in the useful beam during each exposure. In the case of a system, which is to be operated with more than 1 thickness of filtration, this requirement can be met by a filter interlocked with the kilovoltage selector which will prevent X-ray emissions if the minimum required filtration is not in place. (21 CFR 1020.30)

Table 1

(21CFR1020.30(m))

7.19 Intraoral dental X-ray machines shall not be operated at less than a measured 51 kVp effective 2 years after the publication of this rule.

7.20 Modification of certified diagnostic X-ray components and systems

7.20.1 Diagnostic X-ray components and systems certified in accordance with 21 CFR Part 1020 shall not be modified such that the component or system fails to comply with any applicable provision of this Part. (21CFR1020.30(q) but doesn't mention variance option)

7.20.2 The owner of a diagnostic X-ray system who uses the system in a professional or commercial capacity may modify the system provided the modification does not result in the failure of the system or component to comply with the applicable requirements of this Part. The owner who causes such modification need not submit the reports required by this Part, provided the owner records the date and the details of the modification in the system records and maintains this information, and provided the modification of the X-ray system does not result in a failure to comply with this Part. (21CFR1020.30(q)(2))

7.21 Leakage Radiation from the Diagnostic Source Assembly. The leakage radiation from the diagnostic source assembly measured at a distance of 1 meter in any direction from the source shall not exceed 0.88 milligray (mGy) air kerma (vice 100 milliroentgen (mR) exposure) in 1 hour when the X-ray tube is operated at its leakage technique factors. If the maximum rated peak tube potential of the tube housing assembly is greater than the maximum rated peak tube potential for the diagnostic source assembly, positive means shall be provided to limit the maximum X-ray tube potential to that of the diagnostic source assembly. Compliance shall be determined by measurements averaged over an area of 100 cm2 with no linear dimension greater than 20 centimeters. (21CFR1020.30(k))

7.22 Radiation from Components Other Than the Diagnostic Source Assembly. The radiation emitted by a component other than the diagnostic source assembly shall not exceed an air kerma of 18 microgray (vice 2 milliroentgens exposure) in 1 hour at 5 centimeters from any accessible surface of the component when it is operated in an assembled X-ray system under any conditions for which it was designed. Compliance shall be determined by measurements averaged over an area of 100 cm2 with no linear dimension greater than 20 centimeters. (21CFR1020.30(l))

7.23 Maintaining Compliance. Diagnostic X-ray systems and their associated components used on humans and certified pursuant to the Federal X-Ray Equipment Performance Standard (21 CFR Part 1020) shall be maintained in compliance with applicable requirements of that standard.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-8.0** Reserved {#sec-4465-8.0 omnilex-key=us-de-regs-official--title-16--4465-8.0}

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-9.0** Reserved {#sec-4465-9.0 omnilex-key=us-de-regs-official--title-16--4465-9.0}

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-10.0** Reserved {#sec-4465-10.0 omnilex-key=us-de-regs-official--title-16--4465-10.0}

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-11.0** Computed Tomography Equipment {#sec-4465-11.0 omnilex-key=us-de-regs-official--title-16--4465-11.0}

11.1 Requirements for CT Equipment

11.1.1 Accreditation. All stationary diagnostic CT X-ray systems for human use should be accredited by a nationally recognized accrediting organization.

11.1.2 Technical and Safety Information. The technical and safety information relating to the conditions of operation, dose information and imaging performance provided by the CT manufacturer shall be maintained by the facility.

11.1.3 Termination of Exposure

11.1.3.1 Means shall be provided to terminate the X-ray exposure automatically by either de-energizing the X-ray source or shuttering the X-ray beam in the event of equipment failure affecting data collection. Such termination shall occur within an interval that limits the total scan time to no more than 110% of its preset value through the use of either a backup timer or devices which monitor equipment function. (21CFR1020.33(f)(2)(i))

11.1.3.2 A visible signal shall indicate when the X-ray exposure has been terminated through the means required by Part F, subsection 11.1.3.1. (21CFR1020.33(f)(2)(i))

11.1.3.3 The operator shall be able to terminate the X-ray exposure at any time during a scan, or series of scans under CT X-ray system control, of greater than 1/2 second duration. (first part of 21CFR1020.33(f)(2)(ii))

11.1.4 Tomographic Plane Indication and Alignment

11.1.4.1 For any single tomogram system, means shall be provided to permit visual determination of the tomographic plane or a reference plane offset from the tomographic plane. (21CFR1020.33(g)(1))

11.1.4.2 For any multiple tomogram system, means shall be provided to permit visual determination of the location of a reference plane. This reference plane can be offset from the location of the tomographic planes. (version of 21CFR1020.33(g)(2))

11.1.4.3 If a mechanism using a light source is used to satisfy the requirements of Part F, subsection 11.1.4.1 or Part F, subsection 11.1.4.2, the light source shall allow visual determination of the location of the tomographic plane or reference plane under ambient light conditions of up to 500 lux. (21CFR1020.33(g)(5))

11.1.5 Beam-On and Shutter Status Indicators and Control Switches

11.1.5.1 The CT X-ray control and gantry shall provide visual indication whenever X-rays are produced and, if applicable, whether the shutter is open or closed. (First part of 21CFR1020.33(h)(1))

11.1.5.2 Each emergency button or switch shall be clearly labeled as to its function.

11.1.6 Indication of CT Conditions of Operation. The CT X-ray system shall be designed such that the CT conditions of operation to be used during a scan or a scan sequence shall be indicated prior to the initiation of a scan or a scan sequence. On equipment having all or some of these conditions of operation at fixed values, this requirement may be met by permanent markings. Indication of CT conditions of operation shall be visible from any position from which scan initiation is possible. (21CFR1020.33(f))

11.1.7 Additional Requirements Applicable to CT X-Ray Systems Containing a Gantry Manufactured After September 3, 1985

11.1.7.1 The total error in the indicated location of the tomographic plane or reference plane shall not exceed 5 millimeters. (21CFR1020.33(g)(3))

11.1.7.2 If the X-ray production period is less than 1/2 second, the indication of X-ray production shall be actuated for at least 1/2 second. Indicators at or near the gantry shall be discernible from any point external to the patient opening where insertion of any part of the human body into the primary beam is possible. (second part of 21CFR1020.33(h)(1))

11.1.7.3 The deviation of indicated scan increment versus actual increment shall not exceed plus or minus 1 millimeter with any mass from 0 to 100 kilograms resting on the support device. The patient support device shall be incremented from a typical starting position to the maximum incremented distance or 30 centimeters, whichever is less, and then returned to the starting position. Measurement of actual versus indicated scan increment may be taken anywhere along this travel. (21CFR1020.33(i))

11.1.7.4 Premature termination of the X-ray exposure by the operator shall necessitate resetting of the CT conditions of operation prior to the initiation of another scan. (second part of 21CFR1020.33(f)(2)(ii)

11.2 CT Facility Design Requirements

11.2.1 Aural Communication. Provision shall be made for 2-way aural communication between the patient and the operator at the control panel.

11.2.2 Viewing Systems

11.2.2.1 Windows, mirrors, closed-circuit television, or an equivalent shall be provided to permit continuous observation of the patient during irradiation and shall be so located that the operator can observe the patient from the control panel.

11.2.2.2 When the primary viewing system is by electronic means, an alternate viewing system (which may be electronic) shall be available for use in the event of failure of the primary viewing system.

11.3 CT Surveys, Performance Evaluations, Routine QC, and Operating Procedures

11.3.1 Radiation Protection Surveys

11.3.1.1 All CT X-ray systems installed after the effective date of these regulations shall have a radiation protection survey completed by, or under the direct supervision of, the QMP prior to clinical use. Existing systems not previously surveyed shall have a survey made by, or under the direct supervision of, a QMP within 12 months after the effective date of these regulations. In addition, such surveys shall be done after any change in the facility or equipment which might cause a significant increase in radiation hazard.

11.3.1.2 The registrant shall obtain a written report of the survey from the QMP (QE), and a copy of the report shall be made available to the Agency upon request.

11.3.2 System Performance Evaluations

11.3.2.1 The annual testing of the CT X-ray system shall be performed by, or under the personal supervision of, a QMP who assumes the responsibility and signs the final performance evaluation report.

11.3.2.2 Evaluation standards and tolerances shall be established by the QMP (QE) and maintained by the facility. These standards and tolerances shall meet nationally recognized standards and tolerances for the CT X-ray system.

11.3.2.3 The evaluation of a CT X-ray system shall be performed after initial installation, and at least annually thereafter. In addition, the QMP shall complete an evaluation of the CT system prior to clinical use, after any change or replacement of components which, in the opinion of the QMP, could cause a change in the radiation output or image quality.

11.3.2.4 The evaluation shall include but not be limited to:

11.3.2.4.1 Geometric factors and alignment including:

11.3.2.4.1.1 Alignment light accuracy;

11.3.2.4.1.2 Table increment accuracy.

11.3.2.4.2 Image localization from scanned projection radiograph (localization image);

11.3.2.4.3 Radiation beam width;

11.3.2.4.4 Image quality including:

11.3.2.4.4.1 High-contrast (spatial) resolution;

11.3.2.4.4.2 Low-contrast resolution;

11.3.2.4.4.3 Image uniformity;

11.3.2.4.4.4 Noise;

11.3.2.4.5 Artifact evaluation.

11.3.2.4.6 CT number accuracy;

11.3.2.4.7 Image quality for acquisition workstation display devices;

11.3.2.4.8 A review of the results of the routine QC required under Part F, subsection 11.1.3;

11.3.2.4.9 A safety evaluation of audible and visual signals, posting requirements;

11.3.2.4.10 Dosimetry.

11.3.2.5 The measurement of the radiation output of a CT X-ray system shall be performed with a calibrated dosimetry system. The calibration of such system shall be traceable to a national standard. The dosimetry system shall have been calibrated within the preceding 2 years.

11.3.3 Routine Quality Control. A routine QC program on the CT system shall:

11.3.3.1 Be developed by a QMP (QE) and include acceptable tolerances for points evaluated;

11.3.3.2 Incorporate the use of a water equivalent phantom. At a minimum, noise, CT number, and artifacts shall be evaluated.

11.3.3.3 Be completed at time intervals and under system conditions specified by the QMP (QE). The interval shall not to exceed 1 week.

11.3.3.4 Be documented and maintained for inspection by the Agency.

11.3.4 Operating Procedures

11.3.4.1 The operator of the CT X-ray system shall meet the minimum operator requirements of these regulations and be specifically trained on the operational features of the unit by a manufacturer's applications specialist, and/or QMP.

11.3.4.2 The following information shall be readily available to the CT operator:

11.3.4.2.1 Instructions on performing routine QC, including the use of the CT phantom(s), a schedule of routine QC appropriate for the system, allowable variations set by the QMP (QE) for the indicated parameters, and the results of at least the most recent routine QC completed on the system; and

11.3.4.2.2 Scanning protocols established by the RPC, including instructions on reporting deviations.

11.3.4.3 If the QMP (QE) evaluation or routine QC of the CT X-ray system identifies that a system operating parameter has exceeded a tolerance established by the QMP (QE), use of the CT X-ray system on patients shall be limited to those uses permitted by established written instructions of the QMP (QE).

11.4 Radiation Protocol Committee (RPC). The registrant shall develop and maintain an RPC in accordance with the following:

11.4.1 Members of the RPC.

11.4.1.1 Members of the RPC shall include but not be limited to a:

11.4.1.1.1 Radiologist;

11.4.1.1.2 CT Technologist;

11.4.1.1.3 QMP or QE; and

11.4.1.1.4 Other individuals as deemed necessary by the registrant (e.g., Radiation Safety Officer, Chief Medical or Administrative Officer, Radiology Department Administrator/Manager).

11.4.2 If the registrant has more than one site with CT, they may establish a system-wide RPC.

11.4.3 Two or more registrants may form a cooperative RPC as long as each facility has a representative on the committee.

11.4.4 If the registrant has already established a radiation safety or Radiation Protocol Committee (RPC), the requirements of this subsection may be delegated to that committee if the members meet the requirements of Part F, subsection 11.4.1.

11.4.5 Responsibilities of the RPC. The RPC shall:

11.4.5.1 Review existing CT protocols along with the evaluation and implementation of new and innovative technologies that can improve image quality and/or lower patient dose in comparison with the older protocol.

11.4.5.2 Review the capabilities of the individual CT scanner to ensure maximum performance is achieved.

11.4.5.3 Determine and review the protocols used frequently or could result in significant doses. This review shall include acquisition and reconstruction parameters, image quality, and radiation dose. At a minimum, the facility shall review the following clinical protocols, if performed, at least annually:

11.4.5.3.1 Pediatric Head;

11.4.5.3.2 Pediatric Abdomen;

11.4.5.3.3 Adult Head;

11.4.5.3.4 Adult Abdomen;

11.4.5.3.5 Adult Chest;

11.4.5.3.6 Brain Perfusion.

11.4.5.4 Establish and implement written protocols, or protocols documented in an electronic reporting system, that include but are not limited to the following:

11.4.5.4.1 A method to be used to monitor the CT radiation output.

11.4.5.4.2 A standardized protocol naming policy.

11.4.5.4.3 A DRL, notification value, and alert value for CT procedures reviewed in Part F, subsection 11.4.5.3. Notification and alert values may be applied by using trigger values in conformance with NEMA XR-29 or facility-established values and procedures as defined by the QMP.

11.4.5.4.4 Actions to be taken for cases when the dose alert value was exceeded which may include patient follow-up.

11.4.5.4.5 A process determining who has access and authority to make changes to the protocol management systems, including a method to prevent inadvertent or unauthorized modifications to a CT protocol.

11.4.5.5 If CT fluoroscopy is performed, the RPC shall establish and implement operating procedures and training designed to minimize patient and occupational radiation exposure.

11.4.5.6 Provide an annual report to the radiation safety committee or radiation safety officer, in the absence of a radiation safety committee,

11.4.5.7 At a minimum the RPC members in Part F, subsection 11.4.1.1 shall meet as often as necessary to conduct business but at intervals not to exceed 12 months.

11.4.6 Records

11.4.6.1 A record of each RPC meeting shall be maintained. The record shall include the date, names of individuals in attendance, minutes of the meeting, and any action taken, for at least 3 years.

11.4.6.2 The registrant shall maintain a record of RPC policies and procedures.

11.4.6.3 The registrant shall maintain a record of radiation output information so the radiation dose may be estimated in accordance with established protocols (e.g., SSDE). The record shall include:

11.4.6.3.1 Patient identification;

11.4.6.3.2 Type and date of examination;

11.4.6.3.3 Identification of the CT system used; and

11.4.6.3.4 The dose values the CT system provides (e.g., CTDIvol, DLP, SSDE).

11.5 CT systems used in treatment planning. CT systems solely used for treatment planning in radiation oncology shall meet the requirements in Part X, subsection 10.0 of this regulation.

11.6 PET CT and SPECT CT Systems. CT systems solely used to calculate attenuation coefficients in nuclear medicine studies shall meet the requirements in Part F, subsection 11.1 through Part F, subsection 11.4 unless otherwise exempted below:

11.6.1 Part F, subsection 11.1.1 (Accreditation)

11.6.2 In lieu of Part F, subsection 11.3.2, a QMP shall complete a performance evaluation on the CT system following nationally recognized guidelines at intervals not to exceed 12 months.

11.6.3 In lieu of Part F, subsection 11.3.3, routine QC checks shall be completed at intervals not to exceed 1 week. These checks shall be established and documented by a QMP following nationally recognized guidelines.

11.6.4 Part F, subsection 11.3.4.2.2 (RPC)

11.7 Veterinary CT Systems. CT systems, including CBCT systems, solely used in non-human imaging shall meet the requirements of Part F, subsection 11.3.1 (radiation protection surveys) and are otherwise exempt from the standards of Part F, subsection 11.0.

11.8 Cone Beam Computed Tomography Systems

11.8.1 CBCT facilities shall meet Part F, Section 4.0, Part F, subsection 6.1 and 6.11, and Part F, subsection 11.1.2 through Part F, subsection 11.1.7, as applicable.

11.8.2 Beam alignment. The X-ray field in the plane of the image receptor shall not exceed beyond the edge of the image receptor by more than 2% of the SID, when the axis of the X-ray beam is perpendicular to the plane of the image receptor. In addition, the center of the X-ray field shall be aligned with the center of the image receptor to within 2% of the SID.

11.8.3 A performance evaluation shall be performed by, or under the direct supervision of, a QMP. The evaluation shall follow nationally recognized standards and tolerances. The evaluation shall be performed within 30 days of initial installation and least annually, and prior to clinical use, after any change or replacement of components which, in the opinion of the QMP, could cause a change in the radiation output or image quality. The facility shall maintain documentation of the established standards and tolerances and testing results for at least 3 years.

11.8.4 The registrant shall follow the QC recommendations provided by the CBCT manufacturer. In the absence of manufacturer provided QC recommendations, the registrant shall implement and document QC guidelines established by a QMP in accordance with nationally recognized guidelines.

11.8.5 The registrant or RPC, if established, shall implement and document a policy addressing deviations from established protocols.

11.8.6 The CBCT X-ray system shall only be operated by an individual who has been specifically trained in its operation.

11.8.7 The following information shall be readily available to the CBCT operator:

11.8.7.1 Instructions on performing routine QC, including the use of the CBCT phantom(s), a schedule of routine QC appropriate for the system, allowable variations set by the QMP (QE), if required, for the indicated parameters, and the results of at least the most recent routine QC completed on the system.

11.8.8 Exemption. A QMP performance evaluation on CBCT systems capable of operating at no greater than 100 kV or 20 mA shall be performed at least every 2 years.

11.8.9 Exemption. The registrant using fluoroscopy systems capable of CBCT shall meet Part F 11.8, except Part F, subsection 11.1.2 through Part F, subsection 11.1.7 and Part F, subsection 11.8.1.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-12.0** Reserved {#sec-4465-12.0 omnilex-key=us-de-regs-official--title-16--4465-12.0}

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-13.0** Reserved {#sec-4465-13.0 omnilex-key=us-de-regs-official--title-16--4465-13.0}

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-14.0** Reserved {#sec-4465-14.0 omnilex-key=us-de-regs-official--title-16--4465-14.0}

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-15.0** Dual-Energy X-ray Absorptiometry (DXA) (Bone Densitometry). {#sec-4465-15.0 omnilex-key=us-de-regs-official--title-16--4465-15.0}

15.1 DXA systems shall be:

15.1.1 Certified by the manufacturer pursuant to the Medical Device Act and Subchapter C - Electronic Product Radiation Control (EPRC) of Chapter V of the Federal Food, Drug and Cosmetic Act;

15.1.2 Registered in accordance with Part B of these regulations; and

15.1.3 At a minimum, maintained and operated in accordance with the manufacturer's specifications.

15.2 Operator Requirements. In addition to the minimum qualifications outlined in these regulations, operators shall complete training specific to patient positioning and the operation of the DXA system.

15.3 During the operation of any DXA system:

15.3.1 In the absence of a survey performed by or under the supervision of a QMP (QE) determining the minimum distance the operator may be from the patient and radiation source, the operator, ancillary personnel, and members of the general public shall be positioned at least 2 meters from the patient and DXA system during the examination, or alternatively, work shall be performed using protective lead aprons and/or a portable shield.

15.4 Reserved.

15.5 Quality Assurance. In addition to the applicable requirements in Part F, subsection 3.2.1, a facility performing DXA shall:

15.5.1 Conform to the DXA system manufacturer recommendations and recommendations of recognized professional societies such as the International Society for Clinical Densitometry or the American College of Radiology;

15.6 Records. The registrant shall keep the following records for a minimum of 3 years:

15.6.1 The maintenance and QC tests as prescribed by Part F, subsection 15.1.3 and Part F, subsection 15.5.

INFORMATION TO BE SUBMITTED BY PERSONS

PROPOSING TO CONDUCT HEALING ARTS SCREENING

Persons requesting that the Agency approve a healing arts screening program shall submit the following information for evaluation and approval:

a. Name and address of the applicant and, where applicable, the names and addresses of agents within this State;

b. Diseases or conditions for which the X-ray examinations are to be used in diagnoses;

c. A description of the X-ray examinations proposed in the screening program i.e., type and number of views;

d. Description of the population to be examined in the screening program, i.e., age range, sex, physical condition, and other appropriate information;

e. An evaluation of any known alternate methods not involving ionizing radiation that could achieve the goals of the screening program and why these methods are not used instead of the X-ray examinations;

f. An evaluation by a QMP (QE) of the X-ray system(s) to be used in the screening program. The evaluation shall include the following:

1. Documentation that such system(s) satisfy all applicable requirements of these regulations;

2. Measurement of appropriate patient exposures from the X-ray examinations to be performed;

g. A description of the X-ray quality control program;

h. A copy of the protocol information for the X-ray examination procedures to be used;

i. The qualifications of each individual who will be operating the X-ray system(s);

j. The qualifications of the individual who will be supervising the operators of the X-ray system(s). The extent of supervision and the method of work performance evaluation shall be specified;

k. The name and address of the practitioner licensed in the state who will interpret the radiograph(s);

l. Procedures to be used in advising the individuals screened and their practitioner of the healing arts or health care provider of the results of the screening procedure and any further medical needs indicated;

m. Procedures for the retention or disposition of the radiographs and other records pertaining to the X-ray examinations;

n. Frequency of screening of individuals; and

o. The duration of the screening program.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-1.0** Purpose and Scope {#sec-4465-1.0 omnilex-key=us-de-regs-official--title-16--4465-1.0}

This Part provides for the licensing of radioactive material, for purposes of protecting the public health and safety. No person shall receive, possess, use, transfer, sell, own or acquire radioactive material except as authorized in a specific or general license per the U.S. Nuclear Regulatory Commission (NRC), in accordance with Title 10 – Code of Federal Regulations. Primary radioactive material licensing and enforcement authority was transferred to the NRC in 2007, pursuant to the Federal Energy Policy Act of 2005. However, radioactive material facilities must be registered with the State of Delaware in accordance with Part B of this regulation.

RADIATION SAFETY REQUIREMENTS FOR NON-HEALING ARTS RADIATION GENERATING DEVICES (RGD)

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-1.0** Purpose {#sec-4465-1.0 omnilex-key=us-de-regs-official--title-16--4465-1.0}

This Part provides special requirements for non-healing arts radiation generating devices (RGDs) operating between 5 kiloelectron volts (keV) and 1 million electron volts (MeV). For machines operating at energies greater than 1 MeV, see Part I, (Radiation Safety Requirements for Particle Accelerators) of this regulation.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-2.0** Scope {#sec-4465-2.0 omnilex-key=us-de-regs-official--title-16--4465-2.0}

2.1 In addition to the requirements of this Part, all registrants are subject to the requirements of Parts A, B, D, and J of this regulation. This Part does not pertain to radiation safety requirements for X-ray equipment that is explicitly covered in other sections of this regulation (e.g., Diagnostic Machines (Part F), Particle Accelerators (Part I), Therapy Machines (Part X) and Radiation Safety Requirements for Industrial Radiographic Operations (Part E)).

2.2 Radiography that meets the definition of "cabinet radiography" (Part H, Section 4.0) shall be regulated under this Part. This includes certified cabinet X-ray systems.

2.3 Radiography that occurs in a "shielded room" as defined in Part H, Section 4.0 shall be regulated under this Part.

2.4 Industrial radiography that is open-beam, and not in a shielded room and not otherwise listed here, shall be regulated under Part E (Radiation Safety Requirements for Industrial Radiographic Operations) of this regulation.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-3.0** Intent {#sec-4465-3.0 omnilex-key=us-de-regs-official--title-16--4465-3.0}

RGDs are a broad class of equipment that generate X-rays or particle radiation having energies between 5 keV and 1 MeV, and not intended for medical use on humans. If applicable, all RGDs shall comply with FDA performance standards as defined in Title 21 Code of Federal Regulations, parts 1010 thru 1050. Examples of RGDs include, but are not limited to: open and closed analytical X-ray equipment (table top and hand-held), X-ray gauges, cabinet X-ray radiography, security screening units, quality control application devices, ion implantation devices, electron beam welders, non-human use X-ray fluoroscopy, and X-ray irradiators. The intent here is not to define safety parameters by what type of work the X-ray unit performs (analytical, gauge, radiography, etc.), but to classify by hazard (open-beam versus closed-beam) or dose rate. All other non-enclosed beam industrial radiography shall be regulated under Part E of this regulation (Radiation Safety Requirements for Industrial Radiographic Operations).

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-4.0** Definitions {#sec-4465-4.0 omnilex-key=us-de-regs-official--title-16--4465-4.0}

As used in this Part, the following definitions apply:

"Accessible surface" means the external or outside surface of the enclosure or housing provided by the manufacturer. This includes the high-voltage generator, doors, access panels, latches, control knobs, and other permanently mounted hardware and including the plane across the exterior edge of any opening.

"Analytical X-ray equipment" means equipment that generates (by electronic means) and uses ionizing radiation for the purpose of examining the microstructure of materials, i.e. diffraction and spectroscopy (including fluorescence).

"Annual" means approximately every 12 months and not to exceed 14 months.

"Baggage unit". See "Security Screening Unit".

"Beam-port" means an opening on the X-ray apparatus designed to emit a primary beam. This does not include openings on baggage units.

"Cabinet radiography" means industrial radiography using radiation machines not subject to FDA performance standard for cabinet X-ray systems, in an enclosed, interlocked cabinet in which the portion of a material being irradiated is contained, and in which:

i. The radiation machine will not operate unless all openings are closed with interlocks activated;

ii. The cabinet is shielded such that every location on the exterior meets the conditions for an unrestricted area as defined in Part D of these regulations; and

iii. The cabinet is constructed or arranged as to exclude the entrance of any part of the body of an individual during irradiation.

"Cabinet X-ray system" means an X-ray system with the X-ray tube installed in an enclosure which, independently of existing architectural structures except the floor on which it may be placed, is intended to contain at least that portion of a material being irradiated, provide radiation attenuation, and exclude personnel from its interior during generation of X-radiation. An X-ray tube used within a shielded part of a building, or X-ray equipment which may temporarily or occasionally incorporate portable shielding is not a cabinet X-ray system.

"Cathode ray tube" means any device used to accelerate electrons for demonstration or research purposes, except where such cathode ray tube is incorporated into a television or display monitor that is subject to, and has met applicable federal radiation safety performance standards in 21 CFR 1010 and 1020.10.

"Certifiable cabinet X-ray system" means an existing uncertified RGD that has been modified to meet the certification requirements specified in 21 CFR 1020.40.

"Certified cabinet X-ray system" means a RGD certified by the manufacturer in accordance with 21 CFR 1010.2 as being manufactured and assembled pursuant to the provisions of applicable federal radiation safety performance standards in 21 CFR 1010 and 1020.40.

"Closed-beam X-ray equipment" means a system in which the beam path cannot be entered by any part of the body during normal operation.

"Cold-cathode gas discharge tube" means an electronic device in which electron flow is produced and sustained by ionization of contained gas atoms and ion bombardment of the cathode.

"Collimator" means a device for restricting the useful radiation in 1 or more directions.

"Cone Beam CT" (CBCT) means a method of computed tomography that creates a 3-dimensional cone-shaped beam that circles the object once to generate an image.

"Control panel" means a device containing means for regulation and activation of a RGD or for the preselection and indications of operating factors.

"Emergency procedure" means the written pre-planned steps to be taken in the event of actual or suspected exposure of an individual in excess of administrative or regulatory limits. This procedure shall include the names and telephone numbers of individuals to be contacted as well as directives for processing the film badge or other personnel monitoring devices.

"Fail-safe design" means a design in which all realistically anticipated failures of indicators or safety components result in a condition in which individuals are safe from exposure to radiation. For example, if a light indicating "X-RAY ON" fails, the production of X-rays shall be prevented, or if a shutter status indicator fails, the shutter shall close.

"General-use system" means a personnel screening system that delivers an effective dose equal to or less than 0.25 microsieverts (uSv), or 25 microRem (urem) per screening. Given proper justification and certain restrictions, general-use systems may be operated without specific controls that would limit the number of individuals scanned or the number of scans per individual in a year.

"Hand-held X-ray system" means a portable instrument that is designed to operate when held in the hand, e.g., hand-held XRF analytical devices.

"Industrial radiography" means an examination of the structure of materials by nondestructive methods utilizing ionizing radiation to make radiographic images.

"Interlock" means a device or engineered system that precludes access to an area of radiation hazard either by preventing entry or by automatically removing or inactivating the hazard.

"Leakage radiation" means all radiation coming from within the source housing, except the useful beam.

"Limited-use system" means a personnel screening system that is capable of delivering an effective dose greater than 0.25 microsieverts (uSv), or 25 microRem (urem) per screening but cannot exceed an effective dose of 10 microsieverts (uSv), or 1 microRem (urem) per screening. Limited-use systems require additional controls and documentation to ensure that annual individual dose limits required by Part H, subsection 12.5 are not exceeded.

"Local components" means parts of a RGD X-ray system and include areas that are struck by X-rays such as radiation source housings, beam port and shutter assemblies, collimators, sample holders, cameras, goniometers, detectors, and shielding, but do not include power supplies, transformers, amplifiers, readout devices, and control panels.

"Mobile equipment". See "radiation generating device".

"Normal operating procedures" mean step-by-step instructions necessary to accomplish the task. These procedures may include sample insertion and manipulation, equipment alignment, routine maintenance by the registrant, and data recording procedures, which are related to radiation safety.

"Open-beam X-ray equipment" means an open-beam X-ray system in which the beam path could be entered by any part of the body at any time.

"Personnel security screening system" means any X-ray equipment used on humans for security evaluation.

"Portable equipment". See "radiation generating device".

"Primary beam" means the ionizing radiation coming directly from the radiation source through a beam port into the volume defined by the collimation system.

"Qualified expert" means an individual who has satisfactorily fulfilled the training and experience requirements consistent with achieving a level of competency sufficient to function effectively in the position for which registration is sought, in accordance with 4465 Part B. Such individuals must demonstrate to the satisfaction of the Agency their qualifications, for example, individuals certified in the appropriate field by the American Board of Radiology, or the American Board of Health Physics, or the American Board of Medical Physics, or those having equivalent qualifications.

"Radiation generating device (or RGD)" means any system, device, subsystem, or component thereof, which may generate X-rays or particle radiation between 5 keV and 1 MeV, and not intended for healing arts use for humans or animals. A RGD may be fixed or portable, such as:

i. Mobile means RGD equipment mounted on a permanent base with wheels and/or casters for moving while completely assembled;

ii. Portable means RGD equipment designed to be hand-carried;

iii. Stationary means RGD equipment that is installed or placed in a fixed location; or

iv. Transportable means RGD equipment to be installed in a vehicle or that may be readily disassembled for transport or use in a vehicle.

"Radiation safety officer (RSO)" means an individual as defined in Part A, Appendix C of these regulations.

"Radiation source (or X-ray tube) housing" means that portion of an X-ray system which contains the X-ray tube and/or secondary target. Often the housing contains radiation shielding material or inherently provides shielding.

"Radiograph" means a permanent film or digital image produced on a sensitive surface by a form of radiation other than direct visible light or other forms of non-ionizing radiation.

"Radiography" is the process of creating radiographic images.

"Safety device" means a device, interlock or system that prevents the entry of any portion of an individual's body into the primary X-ray beam or that causes the beam to shut off upon entry into its path.

"Scattered radiation" means radiation that has been deviated in direction and / or energy by passing through matter.

"Security screening unit" means a non-human use open-beam or cabinet X-ray system with accessible openings designed for the detection of weapons, bombs, or contraband concealed in baggage, mail, packages or other commodities or structure.

"Shielded room" means a room housing a RGD where, with the RGD at maximum techniques, the exterior room environs meets the unrestricted area limits of 0.02 millisieverts (mSv), or 2 milliRem (mrem) in any 1 hour and 1 millisieverts (mSv), or 100 milliRem (mRem) in a year at 30 centimeters from the barrier. A shielded room does not include a RGD which meet the definition of cabinet X-ray systems.

"Shutter" means a moveable device used to block the useful (or primary) beam emitted from an X-ray tube assembly.

"Source" means the point of origin of the radiation, for example, the focal spot of an X-ray tube.

"Stationary equipment". See "radiation generating device".

"Stray radiation" means the sum of leakage and scatter radiation.

"Warning device" means a visible or audible signal that warns individuals of a potential radiation hazard.

"X-ray generator" means that portion of an X-ray system which provides the accelerating high voltage and current for the X-ray tube.

"X-ray gauge" means an X-ray producing device designed and manufactured for the purpose of detecting, measuring, gauging, or controlling thickness, density, level, or interface location.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-5.0** Exemptions {#sec-4465-5.0 omnilex-key=us-de-regs-official--title-16--4465-5.0}

5.1 Unless utilized in a dedicated location, hand-held RGDs are exempt from the requirements of Section 6.0 Posting of the General Regulatory Provisions of this Part.

5.2 The following machines and equipment are exempt from this regulation:

5.2.1 Domestic television receivers, computer monitors, and electron microscopes, providing the exposure rate at 5 centimeters from any outer surface is less than 0.005 millisieverts (mSv), or 0.5 millirem (mRem) per hour.

5.2.2 Cold-cathode gas discharge tubes, providing the exposure rates shall not exceed 0.1 millisieverts (mSv), or 10 milliRem (mRem) per hour at a distance of 30 centimeters from any point on the external surface of the tube.

5.2.3 Other electrical equipment that produces radiation incidental to its operation for other purposes, providing the dose rate to the whole body at the point of nearest approach to such equipment when any external shielding not integral to the equipment is removed does not exceed 0.25 microsieverts (uSv), or 25 microRem (urem) per year. The production testing or factory servicing for such equipment shall not be exempt.

5.2.4 Equipment described in this subsection shall not be exempt if it is used or handled in such a manner that any individual might receive a dose of radiation in excess of the limits specified in Part D of this regulation.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-6.0** General Regulatory Provisions {#sec-4465-6.0 omnilex-key=us-de-regs-official--title-16--4465-6.0}

6.1 Unless otherwise provided in this Part, this Section applies to all Radiation Generating Devices (RGDs). Certified and Certifiable Cabinet X-ray Systems as defined in this Part shall also meet the requirements of 21 CFR 1020.40.

6.2 Warning Devices

6.2.1 Warning devices shall be labeled so that their purpose is easily identified.

6.2.2 An easily visible warning device light labeled with the words "X-RAY ON," or words having a similar intent, shall be located a) near any switch that energizes an x-ray tube or b) in a conspicuous location near the radiation source housing and radiation beam and visible from all instrument access areas and shall be illuminated only when the tube is energized. This warning light shall be of a fail-safe design.

6.3 Labeling

6.3.1 All RGD equipment shall be labeled with a readily visible and discernible sign or signs bearing the radiation symbol (defined in Part D.901 of these regulations) and the words: "CAUTION RADIATION - THIS EQUIPMENT PRODUCES RADIATION WHEN ENERGIZED," or words having a similar intent, near any switch that energizes an X-ray tube.

6.3.2 For RGDs with designed openings, for object entries (such as baggage units), the following shall be posted at or near each opening: "CAUTION - X-RAY HAZARD: DO NOT INSERT ANY PART OF THE BODY WHEN SYSTEM IS ENERGIZED", or words having similar intent.

6.4 Radiation Source Housing. Each X-ray tube housing shall be subject to the following requirements:

6.4.1 Interlock. When the X-ray tube housing is the primary shielding for the X-ray tube, and is intended to be opened for normal use or maintenance, the housing shall be equipped with an interlock that shuts off the high voltage to the X-ray tube if the housing is opened; and

6.4.2 Radiation Emission Limit. Each X-ray tube housing shall be so constructed that, with all shutters closed, the leakage radiation measured at a distance of 5 centimeters from the X-ray tube housing surface does not exceed 0.025 millisieverts (mSv), or 2.5 milliRem (mRem) per hour. This limit shall be met at the maximum tube rating. For closed-beam systems, this requirement can be met by complying with Part H, subsection 7.4, Radiation Emission Limit. For a RGD in a shielded room, this limit can be met by measuring from any accessible surface outside the room housing the RGD. For hand-held, open-beam RGDs, this requirement can be met by complying with the limits in Part H, subsection 9.3, Radiation Emission Limit.

6.5 Generator Cabinet or High Voltage Source Radiation Emission Limits. Each X-ray generator or high-voltage source shall be supplied with a protective cabinet which limits leakage radiation to 0.025 millisieverts (mSv), or 2.5 milliRem (mRem) per hour at a distance of 5 centimeters measured at the nearest accessible surface. For closed-beam systems, this requirement can be met by complying with subsection 7.1.4. Radiation Emission Limit. For a RGD in a shielded room with the high-voltage generator also inside the shielded room, this limit can be met by measuring from any accessible surface outside the room housing the RGD. For hand-held, open-beam RGDs, this requirement can be met by complying with the limits in Part H, subsection 9.3, Radiation Emission Limit.

6.6 Surveys

6.6.1 Radiation surveys of all RGDs shall be sufficient to show compliance with radiation emission requirements of this Part, and as required by Part D, Section 6.0 (Occupational Dose Limits for Adults) and Part D, Section 13.0 (Dose Limits for Individual Members of the Public) of this regulation. The radiation surveys shall be sufficient to evaluate the magnitude and extent of radiation emissions and the potential radiological hazards that could be present. At a minimum, surveys shall be performed:

6.6.1.1 Upon installation of the equipment, and at least annually thereafter;

6.6.1.2 Following any change in the initial arrangement, number, or type of local components in the system;

6.6.1.3 Following any maintenance requiring the disassembly, removal, or repair of a local component in the system;

6.6.1.4 During the performance of maintenance, calibration and other procedures if the procedures require the presence of a primary X-ray beam while any local component in the system is disassembled or removed;

6.6.1.5 Post bypass of a safety device or interlock as required by Part H, subsection 6.6.7.2;

6.6.1.6 Any time a visual inspection of the local components in the system reveals an abnormal condition;

6.6.1.7 Whenever a personnel monitoring device shows a significant increase over previous monitoring period or readings are approaching the limits specified in Part D, Section 6.0 (Occupational Dose Limits for Adults) of these regulations.

6.6.2 The registrant shall have access to sufficiently calibrated, appropriate and operable radiation survey instruments to make physical radiation surveys as required by this Part. The instruments shall be capable of detecting and measuring the types and levels of radiation involved (including primary, scattered, and leakage radiation).

6.6.3 The registrant shall assure the maintenance and calibration of all monitoring and survey instruments per Part D, subsection 16.2 of this regulation.

6.6.4 Radiation survey measurements shall not be required if a registrant can otherwise demonstrate compliance with the requirements of this Part to the satisfaction of the Agency.

6.6.5 Posting. Each area or room containing an RGD where an individual may receive 0.02 millisieverts (mSv), or 2 milliRem (mRem) in any 1 hour or 1 millisieverts (mSv), or 100 milliRem (mRem) per year shall be conspicuously posted with a sign or signs bearing the radiation symbol (as defined in Part D, Section 28.0 of these regulations) and the words "CAUTION - X-RAY EQUIPMENT," "CAUTION - RADIATION GENERATING DEVICE" or words having a similar intent.

6.6.6 Security. RGDs shall be secured in such a way as to be accessible to, and operated by only authorized and trained personnel.

6.6.7 Operating Requirements

6.6.7.1 Procedures. Normal operating procedures shall be written and available to all RGD workers. No individual shall be permitted to operate a RGD in any manner other than that specified in the procedures unless such individual has obtained the written approval of the radiation safety officer.

6.6.7.2 Bypassing

6.6.7.2.1 No individual shall bypass a safety device, interlock, or remove shielding unless such individual has obtained the written approval of the radiation safety officer. Such approval shall be for a specified period of time.

6.6.7.2.2 When a safety device or interlock has been bypassed, a readily discernible sign bearing the words "SAFETY DEVICE NOT WORKING," or words having a similar intent, shall be placed on the radiation source housing and at the control switch.

6.6.7.2.3 A record of any bypass of a safety device or interlock shall be maintained; the record shall contain such information as the date the alteration was made, type of alteration, length of time the unit remained in the altered condition, post bypass survey and signed by the RSO, individual who made the alteration, and the individual who restored the unit to original condition.

6.6.7.3 Control Panel

6.6.7.3.1 The RGD can only be activated from a control panel.

6.6.7.3.2 All indicators and controls that control the primary beam shall be identifiable and discernible through the use of labels, symbols, software displays or the equivalent.

6.6.7.4 Interlocks

6.6.7.4.1 An interlock shall not be used to de-activate the X-ray tube or RGD, except in an emergency or during testing of the interlock system.

6.6.7.4.2 After triggering any interlock, it shall be possible to reset the RGD to full operation only from a control panel.

6.6.7.4.3 All interlocks shall be of a fail-safe design.

6.6.7.5 Multiple Sources. If more than 1 X-ray tube assembly(s) or focal spot can be operated sequentially or simultaneously from a control panel, visual indicators shall identify which tube assembly(s) or focal spot has been selected. The selectors shall be identified as to their function. If a letter or number is used, a reference card or table explaining the code shall be affixed to the control panel.

6.6.8 Repair or Modification of X-Ray Tube or RGD Systems. Only trained internal personnel authorized by the registrant's senior management, or state-registered Radiation Service Providers shall be permitted to install, repair, or make modifications to the RGD. No operation involving removal of covers, shielding materials or tube housings or modifications to shutters, collimators, or beam stops shall be performed without ascertaining that the tube is off and will remain off until safe conditions have been restored. The main power switch with a lock-out/tag-out, rather than interlocks, shall be used for routine shutdown in preparation for repairs. It is the responsibility of the registrant to assure that qualified personnel install, repair, or make modifications to the RGD.

6.6.9 Testing of Safety Devices

6.6.9.1 Tests of all safety devices, such as interlocks, shutters, warning lights, and required emergency shut-off switches shall be conducted at intervals not to exceed 12 months on all operable RGDs.

6.6.9.2 If any safety device fails during testing, the RGD shall be removed from service until the safety device failure is corrected or proper temporary administrative controls established and approved in writing by the RSO.

6.6.9.3 Records of safety device tests, check dates, findings and corrective actions shall be available for inspection and maintained for 5 years.

6.6.9.4 Records shall include the date of the test, a list of the safety devices tested, survey instrument information, calibration date, the results of the test, the name of the person performing the tests and corrective actions taken for safety devices that fail the required test.

6.6.9.5 Testing of safety devices may be deferred if the unit and/or installation is clearly marked and kept out of service; units and/or installations brought back into service after exceeding the 12 month interval shall be tested prior to use.

6.6.9.6 If testing of a safety device cannot be performed due to manufacturer design, the registrant shall document that the safety device will not be tested and specifically why the safety device cannot be tested.

6.6.10 Instruction and Training. The registrant shall document the scope of training required for the RGD they possess in accordance with this section. No individual shall be permitted to operate or maintain an RGD, or enter a shielded room without appropriate instruction and training. Records shall be maintained onsite of all required training and instruction, and made available for review by the Agency. Each such individual shall receive instruction in and demonstrated competence as to:

6.6.10.1 Types of radiation and identification of radiation hazards associated with the use of the RGD and associated equipment and precautions or measures necessary to minimize radiation exposure;

6.6.10.2 Significance of the various radiation warning, safety devices, and interlocks incorporated into the equipment, or the reasons they have not been installed on certain pieces of equipment and the extra precautions required in such cases;

6.6.10.3 Commensurate with potential hazards of use, biological effects of radiation, radiation risks, and recognition of symptoms of an acute localized exposure;

6.6.10.4 Normal operating procedures for each type of RGD and associated equipment, including having received hands-on training, and procedures to prevent unauthorized use;

6.6.10.5 Procedures for reporting an actual or suspected accidental exposure or other radiation safety concerns, such as any unusual occurrence or malfunction that may involve exposure to radiation; and

6.6.10.6 Performing surveys where applicable.

6.6.11 Radiation Protection Responsibility

6.6.11.1 The registrant's senior management shall make the ultimate decision to use any Radiation Generating Devices (RGD), and be ultimately responsible for radiation safety.

6.6.11.2 The registrant's senior management shall designate an individual responsible for radiation safety, or a radiation safety officer (RSO). This individual shall have direct access to senior management for radiation safety issues. This individual shall have training and experience commensurate with the scope of the radiation safety program to carry out the responsibilities as indicated below.

6.6.11.2.1 Establishing and overseeing operating and safety procedures that maintain radiation exposures as low as reasonably achievable (ALARA), and to review them periodically to ensure that the procedures are current and conform with these regulations;

6.6.11.2.2 Ensuring that individual monitoring devices are properly used by occupationally exposed personnel as required by the regulations, that records are kept of the monitoring results, and that timely notifications are made as required by Part D;

6.6.11.2.3 Investigating and reporting to the agency each known or suspected case of radiation exposure to an individual or radiation level detected in excess of limits established by these regulations and each theft or loss of source(s) of radiation, determining the cause, and taking steps to prevent its recurrence;

6.6.11.2.4 Having a thorough knowledge of management policies, administrative procedures and records of the registration permit-holder and keeping management informed on a periodic basis of the performance of the registrant's radiation protection program, if applicable;

6.6.11.2.5 Assuming control and having the authority to institute corrective actions including shutdown of operations when necessary in emergency situations or unsafe conditions;

6.6.11.2.6 Maintaining records as required by these regulations; and

6.6.11.2.7 Ensuring that personnel are adequately trained and complying with these regulations, the conditions of the certificate of registration, and the operating and safety procedures of the registered permit-holder.

6.6.11.2.8 Ensuring that safety devices, interlocks, warning signals, labels, postings, and signs are functioning and located where required.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-7.0** Additional Requirements for Closed-Beam Radiation Generating Devices (RGDs) {#sec-4465-7.0 omnilex-key=us-de-regs-official--title-16--4465-7.0}

7.1 In addition to the requirements of Part H, Section 6.0, the following applies to all closed-beam X-ray RGDs:

7.1.1 System Enclosure. The radiation source, sample or object, detector, and analyzing crystal (if used) shall be enclosed in a chamber or coupled chambers that cannot be entered by any part of the body during normal operation.

7.1.2 Interlocks. All doors and panels accessing the RGDs shall be interlocked. The interlocks required by this section shall be of a fail-safe design.

7.1.3 Interlock Functions. The system enclosure, sample chamber, etc. closure shall be interlocked with the X-ray tube high voltage supply and/or a shutter in the primary beam so that no X-ray beam can enter the sample or object chamber while it is open unless the interlock has been conspicuously and deliberately defeated. The interlock required by this section shall be of fail-safe design or adequate administrative controls shall be exercised to ensure operations will not continue without a proper functioning interlock.

7.1.4 Radiation Emission Limit. The radiation emission for all closed beam RGDs shall not exceed a dose rate of 0.005 millisieverts (mSv), or 0.5 milliRem (mRem) in 1 hour at 5 centimeters outside any accessible surface.

7.1.5 Security Screening Units. Security screening units shall be provided with means to ensure operator presence at the control area in a position which permits surveillance of the openings and doors during generation of X-radiation.

7.1.6 During an exposure or preset succession of exposures of 1/2 second or greater duration, the means provided shall enable the operator to terminate the exposure or preset succession of exposures at any time.

7.1.7 During an exposure or preset succession of exposures of less than 1/2 second duration, the means provided may allow completion of the exposure in progress but shall enable the operator to prevent additional exposures.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-8.0** Additional Requirements for Open Beam RGDs {#sec-4465-8.0 omnilex-key=us-de-regs-official--title-16--4465-8.0}

8.1 In addition to the requirements in Part H, Section 6.0, the following requirements apply to all open beam RGDs not otherwise addressed in this Part.

8.2 Safety Device

8.2.1 The registrant shall document their justification of the use of open-beam instead of closed-beam systems.

8.2.2 If the registrant needs to use an open-beam system, the registrant shall consider a safety device which prevents the entry of any portion of the operator's body into the path of the primary beam or which causes the primary beam to be shut off upon entry into its path.

8.2.3 If the registrant's use of the open-beam RGD does not permit the use of a safety device to prevent direct body exposure, the registrant shall maintain a written record of a description of the various safety devices that have been evaluated and reasons for why these devices cannot be used. These records shall be available onsite for inspection.

8.2.4 In lieu of the safety device described in section Part H, subsection 8.2 above, the registrant shall employ alternative methods (such as policies and procedures) to minimize the possibility of unnecessary exposure. These alternative methods shall be documented. The documentation shall include information about the absence of safety devices. This documentation shall be available for inspection as long as these methods are employed, plus an additional 5 years.

8.2.5 For portable open-beam RGDs that are manufactured to be used hand-held, or potentially used as a hand-held, without such safety devices, this safety device requirement may be met by complying with all the requirements in Part H, Section 9.0, Additional Requirements for Open-beam, Hand-held RGDs prior to use.

8.3 X-ray On Status. For open beam equipment, RGDs shall be provided with a readily discernible and active indication of:

8.3.1 X-ray tube "on-off" status located near the radiation source housing. The warning lights as required by Part H, subsection 6.2.2 can meet this requirement if the warning lights are readily discernible and viewable by anyone near the primary beam;

8.3.2 Shutter "open-closed" status located at the control panel and near each beam port on the radiation source housing, if the primary beam is controlled with a shutter. The shutter status device shall be clearly labeled as to the meaning of the status device (i.e., whether the shutter is open or closed). The status light at the control panel can meet the requirement for the status light at the beam port if the status light at the control panel is readily discernible and viewable by anyone near the primary beam; and

8.3.3 The X-ray tube "on-off" status indicator and the shutter "open-closed" status indicators shall be of a fail-safe design.

8.4 Labeling. Each unit will be labeled at or near the x-ray exit beam port to identify the location of the beam with the words, "CAUTION - X-RAY BEAM", "CAUTION - HIGH INTENSITY X-RAY BEAM", or words having a similar intent.

8.5 Beam Ports. Unused beam ports on radiation source housings shall be secured in the closed position in a manner which will prevent inadvertent opening.

8.6 Shutters. On open-beam RGD configurations that are designed to accommodate interchangeable components, each beam port on the radiation source housing shall be equipped with a shutter that cannot be opened unless a collimator or a component coupling has been connected to the beam port.

8.7 Radiation Emission Limits. The local components of an open-beam RGD shall be located and arranged and shall include sufficient shielding or access control such that no radiation emissions exist (exclusive of the primary beam) in any area surrounding the local component group which could result in a dose to an individual present therein in excess of the dose limits as outlined in Part D, Section 13.0 (Dose Limits for Individual Members of the Public) of this regulation. These emissions shall be met at any specified tube rating.

8.8 Primary Beam Attenuation. In cases where the primary X-ray beam is not intercepted by the detector device under all conditions of operation, protective measures shall be provided, such as auxiliary shielding or administrative procedures, to avoid exposure to any individual from the transmitted primary X-ray beam.

8.9 Operator Attendance. The operator shall be in immediate attendance at all times when the equipment is in operation except when the area is locked or the equipment is secured to protect against unauthorized or accidental entry.

8.10 Control of Access. If the RGD is not in a restricted area (as defined in Part A of these regulations), the operator shall be able to control access to the RGD at all times during operation. If the RGD is not in a restricted area (as defined in Part A) and the RGD is capable of creating a radiation area or a high radiation area (as defined Part A), the operator shall be able to control access to the RGD at all times during operation, and:

8.10.1 Radiation areas shall be conspicuously identified. The radiation source shall be within a conspicuous perimeter (e.g., rope, tape, or other barrier) that identifies the area in which the dose equivalent exceeds 0.05 millisieverts (mSv), or 5 milliRem (mRem) in 1 hour. The area described by the temporary barricade shall be suitably posted with "CAUTION -RADIATION AREA" signs. The operator shall ensure that no one is inside or enters the radiation area during operation of the RGD;

8.10.2 High radiation areas shall be conspicuously identified. The radiation source shall be within a conspicuous perimeter (e.g., rope, tape, or other barrier) that identifies the area in which the dose equivalent exceeds 1 millisieverts (mSv), or 100 milliRem (mRem) in one hour. The area described by the temporary barricade shall be suitably posted with "CAUTION - HIGH RADIATION AREA" signs. The operator shall ensure that no one is inside or enters the high radiation area during operation of the RGD;

8.10.3 The operator shall perform a visual check of the controlled area to ensure it is free of all unauthorized personnel immediately prior to activating or exposing the radiation source;

8.10.4 Surveillance of the exposure area shall be maintained during operation, either by visual or by other reliable means to ensure that no person enters the area;

8.10.5 With the exception of hand-held X-ray systems, following the conclusion of an exposure, the operator shall use a suitable calibrated and operable radiation detection instrument to verify that the radiation source is in its fully shielded condition or that the X-ray tube has been de-energized; or,

8.10.6 A personal alarming dose rate meter may be worn to approach the work area if the device is appropriately designed and calibrated for the type of X-ray emitted (i.e., pulse or continuous), set at an appropriate level to detect the presence of the source, for example 0.02 millisieverts (mSv), or 2 milliRem (mRem) per hour, and has been source-checked prior to use. The radiation in the work area must be reasonably uniform so that the device responds to radiation exposure to any part of the body. It may not be used to measure radiation levels, nor may it be used to indicate the presence of the source for potential non-uniform exposure, such as may occur during machine maintenance or work in a RGD target area;

8.10.7 Measurement of radiation levels for a radiation survey shall be performed using an appropriate calibrated radiation survey meter (see Part D, subsections 16.2 and 17.1). A radiation survey meter shall also be used when there is potential for non-uniform exposure to personnel, such as may occur during machine maintenance or work in a RGD target area;

8.10.8 During the initial exposure, the radiation levels shall be measured around the perimeter of the controlled area. The perimeter shall be adjusted accordingly to meet the access control requirement for radiation areas or high radiation areas; and;

8.10.9 The survey around the perimeter shall be made for each new operating condition and the perimeter adjusted accordingly. The area of operation shall be monitored periodically if radiation levels are variable.

8.10.10 Instruction and Training. In addition to the requirements in Part H, Section 6.0, no individual shall be permitted to operate or maintain an open-beam RGD unless such individual has received more specific and detailed instruction in and documented, demonstrated competence as to:

8.10.10.1 Sources and magnitude of common radiation exposure;

8.10.10.2 Units of radiation measurement;

8.10.10.3 Radiation protection concepts of time, distance, shielding, and ALARA;

8.10.10.4 Procedures and rights of a declared pregnancy;

8.10.10.5 Regulatory requirements and area postings;

8.10.10.6 Worker, embryo/fetus, and public dose limits;

8.10.10.7 Proper use of survey instruments and dosimetry; and

8.10.10.8 The policies and procedures required by Part H, subsection 6.6.

8.10.11 Personnel Monitoring. In addition to the requirements of Part D, Section 6.0 of this regulation (Occupational Dose Limits for Adults), extremity dosimetry shall be provided and used by:

8.10.11.1 Personnel working with or routinely working near and having potential for exposure to, the primary beam of an open-beam RGD; and

8.10.11.2 Personnel maintaining RGDs if the maintenance procedures require the presence of a primary radiation beam when any local component in the RGD is disassembled or removed.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-9.0** Additional Requirements for Open-beam, Hand-held RGDs {#sec-4465-9.0 omnilex-key=us-de-regs-official--title-16--4465-9.0}

9.1 In addition to the requirements in Part H, Sections 6.0 and 8.0, the following requirements in this Section apply to open-beam, hand-held RGDs.

9.2 Procedures. All registrants possessing open-beam, hand-held RGDs shall have available for review to the Agency operating policies and procedures that contain measures to insure that:

9.2.1 Radiation protection is provided equivalent to that afforded in Part D, Section 13.0 of this regulation (Dose Limits for Individual Members of the Public);

9.2.2 Radiation protection is provided equivalent to that afforded in Part H, subsection 8.8 (Primary Beam Attenuation);

9.2.3 The operator will not hold the object or target during operation of the RGD and that the operator's hands will not approach the primary beam;

9.2.4 The operator will not aim the primary beam at him/herself or at any individual during operation of the RGD; and

9.2.5 Operator radiation exposure is as low as reasonably achievable (ALARA), for example, by use of ancillary equipment that will reduce exposure.

9.3 Training. In addition to the training requirements of Part H, subsection 6.6.10 and Part H, subsection 8.10.10 above, the registrant shall provide training for all users and operators on the subjects in Part H, subsection 9.2. Records shall be maintained of all user and operator training.

9.4 Radiation Emission Limit. For hand-held RGDs, the limits of Part H, subsection 6.4.2 (Radiation Source Housing Radiation Emission Limits) and Part H, subsection 6.5 (Generator Cabinet or High Voltage Source Radiation Emission Limits), excluding the primary beam, shall be met if the radiation emission at any accessible surface of the RGD does not exceed 0.025 millisieverts (mSv), or 2.5 milliRem (mRem) per hour at 5 centimeters.

9.5 Extremity Monitoring. For the purposes of the requirements in Part H, subsection 10.1.10 (extremity monitoring), operators of hand-held RGDs shall be considered as working near the primary beam. Extremity dosimeters are required if dose may exceed 10% of the annual occupational dose limit.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-10.0** Shielded Room RGDs {#sec-4465-10.0 omnilex-key=us-de-regs-official--title-16--4465-10.0}

10.1 For RGDs that do not meet the limits of Part D, Section 13.0 (Dose Limits to Individual Members of the Public), the RGD can be maintained inside a shielded room such that the exterior of the room meets the limits of Part D, Section 13.0 of these regulations (Dose Limits to Individual Members of the Public) when the RGD is activated. RGDs in a shielded room shall be required to meet only the requirements of Part H, Section 6.0 (General Requirements) and the following:

10.1.1 Posting. The door to the room containing the RGD shall be posted "CAUTION - RADIATION AREA", or "CAUTION - HIGH RADIATION AREA", or "GRAVE DANGER - VERY HIGH RADIATION AREA", as required by Part D of this regulation.

10.1.2 Entrance Interlocks. All entrances into the shielded room shall be provided with interlocks. After an interlock has been interrupted, broken, or tripped, it shall be possible to cause X-rays to be produced again only from the control panel. Interlocks shall not be used to shut off the X-ray equipment except in an emergency or during testing.

10.1.3 Entrance Warning Devices. All entrances into the shielded room shall be provided with a conspicuously visible warning device, which need not be flashing or rotating but which operates only when radiation is being produced. The warning device shall be labeled in accordance with Part H, subsection 6.2.

10.1.4 Room Warning Lights. The interior of the shielded room shall be provided with flashing or rotating warning lights that operate when, and only when, radiation is being produced. These lights shall be positioned so that they can be observed from any position or orientation within the room. The lights shall be posted indicating the meaning of the warning signal and instructions on what to do; the posting shall be legible, conspicuous, and accessible to view by personnel both inside and outside the room.

10.1.5 Audible Room Warning Device. An audible warning signal within the room shall be actuated for at least 10 seconds immediately prior to the first initiation of radiation after the closing of any opening that can admit personnel. The registrant shall post the meaning of the warning signal and instructions on what to do; the posting shall be legible, conspicuous, and accessible to view by personnel within the room.

10.1.6 Emergency Shut-off. If dose rates exceed the High Radiation Area limits (as defined in Part A of this regulation), emergency shut-off switches shall be located within the high radiation areas so as to be accessible to individuals therein within 10 seconds. These switches and their mode of operation shall be identified by a conspicuously posted sign adjacent to the switch. The emergency shut-off switches shall include a manual reset that must be reset at the switch before X-rays can again be produced from the control panel. After an emergency shut-off switch has been activated, it shall be possible to produce X-rays again only from the control panel.

10.1.7 Separate Electrical Systems. The interlock system and the emergency shut-off system shall be separate electrical and/or mechanical systems.

10.1.8 Egress from Shielded Room. A person within the room housing a RGD shall be able to egress at all times.

10.1.9 Entry into the Shielded Room

10.1.9.1 After each exposure and before entry of any personnel, a survey shall be performed upon entry to the shielded room to determine that the RGD is no longer producing radiation.

10.1.9.2 Personnel devices providing an audible signal when activated by radiation will be acceptable for the survey requirement of Part H, subsection 10.1.5.

10.1.9.2.1 Proper operation of the audible detection device shall be checked daily and a record maintained of this check.

10.1.9.2.2 The audible device shall be designed so as to clearly indicate entry into a 0.02 mSv (2 mrem) per hour or greater radiation field.

10.1.9.2.3 All personnel working with the RGD shall be provided with such a device.

10.1.9.3 Stationary area monitors providing an audible signal when activated by radiation will be acceptable for the survey requirement of Part H, subsection 10.1.9.1.

10.1.9.3.1 Proper operation of the stationary detection device shall be checked daily and a record maintained of this check.

10.1.9.3.2 The stationary device shall be designed so as to clearly indicate entry into a 0.02 mSv (2 mrem) per hour or greater radiation field.

10.1.9.3.3 Stationary area monitors shall be calibrated annually to determine that the audible signal operates at a 0.02 mSv (2 mrem) per hour radiation field.

10.1.10 Personnel Monitoring. All personnel associated with the X-ray equipment shall be provided with personnel monitoring devices that shall be calibrated for the X-ray energies being utilized. Records of personnel exposure shall be maintained.

10.1.11 Training. No registrant shall permit any individual to operate a RGD in a shielded room until such individual has received a copy of, instruction in, and demonstrated an understanding of, operating and emergency procedures for the unit and competence in its use. Records shall be maintained of all operator training.

10.1.12 Control Panel Security. The equipment control panel shall be provided with a locking device to prevent unauthorized use. Such locking device shall, when locked, prevent the production of radiation by the equipment.

10.1.13 Malfunctions. If a safety or warning device malfunctions, the control panel shall be locked and tagged "DO NOT USE, Malfunctioning Safety Device" in the "off" position. The control panel shall not be used, except as may be necessary for repair or replacement of the malfunctioning safety or warning device, until the safety or warning device is functioning properly.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-11.0** RGDs Used in Personnel Security Screening or Vehicle Screening for Public Protection {#sec-4465-11.0 omnilex-key=us-de-regs-official--title-16--4465-11.0}

11.1 In addition to the General Requirements in Part H, Section 6.0, the following requirements in this section apply. A person requesting Agency approval for a RGD to be used in Personnel Security Screening or Vehicle Screening with intended exposure of human occupants to the primary beam for public protection shall submit in writing the following information to the Agency for evaluation and approval, and show how the dose limits noted below will be met.

11.2 Efficacy Evaluation. An evaluation of all known alternate methods that could achieve the goals of the security screening program, and why these methods will not be used in preference to the proposed approach utilizing ionizing radiation.

11.3 Equipment Evaluation. RGDs used for non-healing arts personnel security screening of humans shall be evaluated annually by a qualified expert for optimization of image quality and radiation dose.

11.4 Dose Limits for General-Use Systems. For general-use screening systems, where system is used without regard to the number of individuals scanned or number of scans per individual in a year, an effective dose for a single complete screening shall be limited to 0.25 uSv (25 urem).

11.5 Dose Limits for Limited-Use Systems. For limited-use screening systems, where equipment is capable of operation greater than 0.25 microsieverts (uSv), or 25 microRem (uRem) per screening, and is used with discretion, the effective dose per screening shall be less than or equal to 0.01 millisieverts (mSv), or 1 milliRem (mRem).

11.6 Dose Limits for Repeat Security Screenings. Individuals subject to repeat security screening at a single venue shall not receive an effective dose greater than 0.25 millisieverts (mSv), or 25 milliRem (mRem) in any 1year at the registrant or licensee's facility.

11.7 Vehicle Limitations

11.7.1 When the procedures for operation of a mobile or fixed RGD used for security screening of vehicles includes knowingly exposing human occupants to the primary beam when screening vehicles, structures or containers, the system shall be subject to the same exemption requirements as general-use or limited-use systems as provided in Part H, subsections 12.1 through 12.1.4.

11.7.2 If the requirements in Part H, subsection 11.0 through Part H, subsection 11.7 cannot be met if vehicle occupants are knowingly exposed to the primary beam of a security screening system, then there shall be means to assure the occupied portion of the vehicle is outside of the scan area while the primary beam is emitted or procedures shall be established and implemented to assure that no occupants are present in the vehicle during screening.

11.7.3 The effective dose to an individual for a single inadvertent exposure to the primary beam shall not exceed 5 millisieverts (mSv), or 500 milliRem (mRem) and should not exceed 1 millisieverts (mSv), or 100 milliRem (mRem). The reliability of the procedure used to assure that there are no occupants of a vehicle to be scanned shall be commensurate with the potential severity of an inadvertent exposure. If the 5 millisieverts (mSv), or 500 milliRem (mRem) limit cannot be assured, a pre-screening with a mode or system which can meet the limits in Part H, subsection 11.4 through Part H, subsection 11.6 shall be used to verify there are no occupants in the vehicle being examined.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-12.0** Application for Exemptions {#sec-4465-12.0 omnilex-key=us-de-regs-official--title-16--4465-12.0}

12.1 Any RGD user or manufacturer that cannot meet the applicable requirements of the above sections in this Part shall submit to the Agency a request for an exemption to the specific regulation in question. The exemption request shall demonstrate to the Agency's satisfaction:

12.1.1 That the use of the RGD will not result in undue hazard to public health and safety or property;

12.1.2 That compliance would require replacement or substantial modification of the RGD;

12.1.3 That the registrant will achieve, through other means, radiation protection equivalent to that required by the regulation; and

12.1.4 Why the regulatory standard or requirement could not be met.

NOTICES, INSTRUCTIONS AND REPORTS TO WORKERS; INSPECTIONS

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-1.0** Purpose and Scope {#sec-4465-1.0 omnilex-key=us-de-regs-official--title-16--4465-1.0}

This Part establishes requirements for notices, instructions and reports by licensees or registrants to individuals engaged in activities under a license or registration including but not limited to employees, and options available to such individuals in connection with Agency inspections of licensees or registrants to ascertain compliance with the provisions of the Act and regulations, orders, and licenses issued thereunder regarding radiological working conditions. The regulations in this Part apply to all persons who receive, possess, use, own, sell or transfer sources of radiation registered with or licensed by the Agency pursuant to Parts B and C of this regulation.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-2.0** General Regulatory Provisions - Posting of Notices to Workers {#sec-4465-2.0 omnilex-key=us-de-regs-official--title-16--4465-2.0}

2.1 Each licensee or registrant shall post current copies of the following documents:

2.1.1 The regulations in this Part and in Part D of these regulations;

2.1.2 The license or certificate of registration;

2.1.3 The operating safety procedures applicable to activities under the license or registration; and

2.1.4 Any notice of violation involving radiological working conditions, proposed imposition of administrative penalty, or order issued pursuant to Part A of this regulation, and any response from the licensee or registrant.

2.2 If posting of a document specified in subsections 2.1.1, or 2.1.3 is not practicable, the licensee or registrant may post a notice which describes the document and states where it may be examined.

2.3 Agency Form X "Notice to Workers" shall be posted conspicuously by each licensee or registrant as required by this regulation, see Appendix A.

2.4 Agency documents posted pursuant to subsection 2.1.4 shall be posted conspicuously within 5 working days after receipt of the documents from the Agency; the licensee's or registrant's response, if any, shall be posted within 5 working days after dispatch from the licensee or registrant. Such documents shall remain posted for a minimum of 5 working days or until action correcting the violation has been completed, whichever is later.

2.5 Documents, notices, or forms posted pursuant to Section 2.0 shall appear in a sufficient number of places to permit individuals engaged in work under the license or registration to observe them on the way to or from any particular work location to which the document applies, shall be conspicuous, and shall be replaced if defaced or altered.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-3.0** Instructions to Workers {#sec-4465-3.0 omnilex-key=us-de-regs-official--title-16--4465-3.0}

3.1 All individuals who in the course of employment, education, or training are likely to receive in a year an occupational dose in excess of 1 millisievert (100 mrem):

3.1.1 Shall be kept informed of the storage, transfer, or use of sources of radiation in the licensee's or registrant's workplace;

3.1.2 Shall be instructed in the health protection problems associated with exposure to radiation or radioactive material to the individual and potential offspring, in precautions or procedures to minimize exposure, and in the purposes and functions of protective devices employed;

3.1.3 Shall be instructed in, and instructed to observe, to the extent within the worker's control, the applicable provisions of these regulations and licenses for the protection of personnel from exposures to radiation or radioactive material;

3.1.4 Shall be instructed of their responsibility to report promptly to the licensee or registrant any condition which may constitute, lead to, or cause a violation of the Act, these regulations, or license condition, or any unnecessary exposure to radiation or radioactive material;

3.1.5 Shall be instructed in the appropriate response to warnings made in the event of any unusual occurrence or malfunction that may involve exposure to radiation or radioactive material; and

3.1.6 Shall be advised as to the radiation exposure reports which workers shall be furnished pursuant to Section 4.0.

3.2 In determining those individuals subject to the requirements of subsection 3.1, licensees or registrant must take into consideration assigned activities during normal and abnormal situations involving exposure to radiation and/or radioactive material which can reasonably be expected to occur during the life of a licensed facility. The extent of these instructions shall be commensurate with potential radiological health protection problems present in the workplace.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-4.0** Notifications and Reports to Individuals {#sec-4465-4.0 omnilex-key=us-de-regs-official--title-16--4465-4.0}

4.1 Radiation exposure data for an individual and the results of any measurements, analyses, and calculations of radioactive material deposited or retained in the body of an individual shall be reported to the individual as specified in this section. The information reported shall include data and results obtained pursuant to these regulations, orders, or license conditions, as shown in records maintained by the licensee or registrant pursuant to Part D, Section 39.0 of this regulation. Each notification and report shall:

4.1.1 Be in writing;

4.1.2 Include appropriate identifying data such as: the name of the licensee or registrant, the name of the individual, and the individual's unique identification number, such as employee number or Social Security Number;

4.1.3 Include the individual's exposure information; and

4.1.4 Contain the following statement:

"This report is furnished to you under the provisions of the Delaware Radiation Control Regulations, Part J. You should preserve this report for further reference."

4.2 The licensee shall provide an annual report to each individual required to be monitored under these regulations of the dose received in that monitoring year if their occupational dose is in excess of 1 millisievert (100 mrem).

4.3 Each licensee or registrant shall furnish a written report of the worker's exposure to sources of radiation at the request of a worker currently or formerly engaged in activities controlled by the licensee or registrant. The report shall include the dose record for each year the worker was required to be monitored pursuant to Part D, Section 17.0 of these regulations such report shall be furnished within 30 days from the date of the request, or within 30 days after the dose of the individual has been determined by the licensee or registrant, whichever is later. The report shall cover the period of time that the worker's activities involved exposure to sources of radiation and shall include the dates and locations of work under the license or registration in which the worker participated during this period.

4.4 When a licensee or registrant is required pursuant to Sections 46.0, 47.0, 48.0, or 49.0 of this regulation to report to the Agency any exposure of an individual to sources of radiation, the licensee or the registrant shall also provide the individual a written report on the exposure data included therein. Such reports shall be transmitted at a time not later than the transmittal to the Agency.

4.5 At the request of a worker who is terminating employment with the licensee or registrant in work involving exposure to radiation or radioactive material, during the current year, each licensee or registrant shall provide at termination to each such worker, or to the worker's designee, a written report regarding the radiation dose received by that worker from operations of the licensee or registrant during the current year or fraction thereof. If the most recent individual monitoring results are not available at that time, a written estimate of the dose shall be provided together with a clear indication that this is an estimate.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-5.0** Presence of Representatives of Licensees or Registrants and Workers During Inspection {#sec-4465-5.0 omnilex-key=us-de-regs-official--title-16--4465-5.0}

5.1 Each licensee or registrant shall afford to the Agency at all reasonable times opportunity to inspect materials, machines, activities, facilities, premises, and records pursuant to this regulation.

5.2 During an inspection, Agency inspectors may consult privately with workers as specified in Section 6.0. The licensee or registrant may accompany Agency inspectors during other phases of an inspection.

5.3 If, at the time of inspection, an individual has been authorized by the workers to represent them during Agency inspections, the licensee or registrant shall notify the inspectors of such authorization and shall give the workers' representative an opportunity to accompany the inspectors during the inspection of physical working conditions.

5.4 Each worker's representative shall be routinely engaged in work under control of the licensee or registrant and shall have received instructions as specified in Section 3.0.

5.5 Different representatives of licensees or registrants and workers may accompany the inspectors during different phases of an inspection if there is no resulting interference with the conduct of the inspection. However, only 1 workers' representative at a time may accompany the inspectors.

5.6 With the approval of the licensee or registrant and the workers' representative, an individual who is not routinely engaged in work under control of the licensee or registrant, for example, a consultant to the licensee or registrant or to the workers' representative, shall be afforded the opportunity to accompany Agency inspectors during the inspection of physical working conditions.

5.7 Notwithstanding the other provisions of Section 5.0, Agency inspectors are authorized to refuse to permit accompaniment by any individual who deliberately interferes with a fair and orderly inspection. With regard to areas containing information classified by an Agency of the US Government in the interest of national security, an individual who accompanies an inspector may have access to such information only if authorized to do so. With regard to any area containing proprietary information, the workers' representative for that area shall be an individual previously authorized by the licensee or registrant to enter that area.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-6.0** Consultation with Workers During Inspections {#sec-4465-6.0 omnilex-key=us-de-regs-official--title-16--4465-6.0}

6.1 Agency inspectors may consult privately with workers concerning matters of occupational radiation protection and other matters related to applicable provisions of these regulations and licenses to the extent the inspectors deem necessary for the conduct of an effective and thorough inspection.

6.2 During the course of an inspection, any worker may bring privately to the attention of the inspectors, either orally or in writing, any past or present condition which the worker has reason to believe may have contributed to or caused any violation of the Act, these regulations, or license condition, or any unnecessary exposure of an individual to sources of radiation under the licensee's or registrant's control. Any such notice in writing shall comply with the requirements of subsection 7.1.

6.3 The provisions of subsection 6.2 shall not be interpreted as authorization to disregard instructions pursuant to Section 3.0

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-7.0** Requests by Workers for Inspections {#sec-4465-7.0 omnilex-key=us-de-regs-official--title-16--4465-7.0}

7.1 Any worker or representative of workers believing that a violation of the Act, this regulation, or license conditions exists or has occurred in work under a license or registration with regard to radiological working conditions in which the worker is engaged may request an inspection by giving notice of the alleged violation to the Office of Radiation Control. Any such notice shall be in writing, shall set forth the specific grounds for the notice, and shall be signed by the worker or representative of the workers. A copy shall be provided to the licensee or registrant by the Office of Radiation Control no later than at the time of inspection except that, upon the request of the worker giving such notice, such worker's name and the name of individuals referred to therein shall not appear in such copy or on any record published, released, or made available by the Agency, except for good cause shown.

7.2 If, upon receipt of such notice, the Office of Radiation Control determines that the complaint meets the requirements set forth in subsection 7.1, and that there are reasonable grounds to believe that the alleged violation exists or has occurred, an inspection shall be made as soon as practicable to determine if such alleged violation exists or has occurred. Inspections pursuant to Section 7.0 need not be limited to matters referred to in the complaint.

7.3 No licensee, registrant, or contractor or subcontractor of a licensee or registrant shall discharge or in any manner retaliate against any worker because such worker has filed any complaint or instituted or caused to be instituted any proceeding under these regulations or has testified or is about to testify in any such proceeding or because of the exercise by such worker on behalf of such worker or others of any option afforded by this Part.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-8.0** Inspections Not Warranted; Review {#sec-4465-8.0 omnilex-key=us-de-regs-official--title-16--4465-8.0}

8.1 If the Office of Radiation Control determines, with respect to a complaint under Section 7.0, that an inspection is not warranted because there are no reasonable grounds to believe that a violation exists or has occurred, the Office of Radiation Control shall notify the complainant in writing of such determination. The complainant may obtain review of such determination by submitting a written statement of position with the Division of Public Health. Such Agency will provide the licensee or registrant with a copy of such statement by certified mail, excluding, at the request of the complainant, the name of the complainant. The licensee or registrant may submit an opposing written statement of position with the Division of Public Health. The Division of Public Health will provide the complainant with a copy of such statement by certified mail.

8.2 Upon the request of the complainant, the Division of Public Health may hold a conference in which the complainant and the licensee or registrant may orally present their views. A conference may also be held at the request of the licensee or registrant, but disclosure of the identity of the complainant will be made only following receipt of written authorization from the complainant. After considering all written and oral views presented, the Division of Public Health shall affirm, modify, or reverse the determination of the “Office of Radiation Control” and furnish the complainant and the licensee or registrant a written notification of the decision and the reason therefore.

8.3 All decisions of the Division shall be final and conclusive. Where the licensee or registrant is in disagreement with the action of the Division, the licensee or registrant may appeal the Division’s decision to the Superior Court within 30 days of service or of the postmarked date of the copy of the decision mailed to the licensee or registrant. The appeal shall be on the record to the Superior Court and shall be as provided in §§10142 - 10145 of Title 29.

8.4 If the Office of Radiation Control determines that an inspection is not warranted because the requirements of subsection 7.1 have not been met, the complainant shall be notified in writing of such determination. Such determination shall be without prejudice to the filing of a new complaint meeting the requirements of subsection 7.1.

NOTICE TO WORKERS AGENCY FORM X

STANDARDS FOR PROTECTION AGAINST RADIATION; NOTICES INSTRUCTIONS AND REPORTS TO WORKERS; INSPECTIONS

In Part D of the Delaware Radiation Control Regulations, the Authority on Radiation has established standards for your protection against radiation hazards. In Part J of the Delaware Radiation Control Regulations, the Authority on Radiation Protection has established certain provisions for the options of workers engaged in work under an agency license or registration.

THE REGISTRANT RESPONSIBILITY The Registrant is required to:

1. Apply these regulations to work involving sources of radiation.

2. Post or otherwise make available to you a copy of the Delaware Radiation Control Regulations, and the operating procedures which apply to work you are engaged in, and explain their provisions to you.

3. Post Notice of Violation involving radiological working conditions, and any proposed imposition of administrative penalties and orders.

YOUR RESPONSIBILITY AS A WORKER

You should familiarize yourself with provisions of the Delaware Radiation Control Regulations listed below and facility procedures for safe operation of radiation sources in your workplace. You should observe these provisions for your own protection, and the protection of your co-workers.

WHAT IS COVERED BY THESE REGULATIONS

1. Limits on exposure to radiation and radioactive material in restricted and unrestricted areas;

2. Measures to be taken after accidental exposure;

3. Personnel monitoring, surveys and equipment;

4. Caution signs, labels, and safety interlock equipment;

5. Exposure records and reports;

6. Options for workers regarding Agency inspections; and

7. Related matters.

POSTING REQUIREMENT

COPIES OF THIS NOTICE MUST BE POSTED IN A SUFFICIENT NUMBER OF PLACES IN EVERY ESTABLISHMENT WHERE WORKERS ARE ENGAGED IN ACTIVITIES LICENSED OR REGISTERED, PURSUANT TO PART B OR PART C, BY THE OFFICE OF RADIATION CONTROL, TO PERMIT INDIVIDUALS WORKING IN OR FREQUENTING ANY PORTION OF A RESTRICTED AREA TO OBSERVE A COPY ON THE WAY TO OR FROM THEIR PLACE OF WORK.

REPORTS ON YOUR RADIATION EXPOSURE HISTORY

1. The Delaware Radiation Control Regulations require that the registrant give you a written report if you receive an exposure in excess of any applicable limit set forth in these regulations. The basic limits for exposure to workers are set forth in Part D, Sections 5.0, 6.0, 7.0, 8.0, 9.0 and 12.0 of the regulations.

2. If personnel monitoring is required for your job, and if you request information on your radiation exposures;

(a) The registrant or your employer/or supervisor must advise you annually of your exposure to radiation while you are working, as set forth in Part J, subsections 4.1 and 4.2;

(b) The registrant or your employer/or supervisor must give you a written report, of your radiation exposures upon leaving work in the registered facility as set forth in Part J, subsections 4.3 and 4.5.

INSPECTIONS

All licensed or registered activities are subject to inspection by representatives of the Office of Radiation Control. In addition, any worker or representative of workers who believes that there is a violation of the Delaware Radiation Control Act, the regulations issued thereunder, or the terms of the facility license or registration with regard to radiological working conditions in which the worker is engaged, may request an inspection by sending a notice of the alleged violation to the Office of Radiation Control. The written request must set forth the specific grounds for the notice, and must be signed by the worker as the representative of the workers. During inspections, Agency inspectors may confer privately with workers, and any worker may bring to the attention of the inspectors any past or present condition which they believe contributed to or caused any violation as described above.

A PDF version Part J Appendix A Form Y is available here:

https://regulations.delaware.gov/AdminCode/title16/Division of Public Health/Health Systems Protection (HSP)/4465 Part J Appendix A Form Y (Replacement) 06.01.24.pdf

Part J, Agency Form Y Page 1 of 3

INSTRUCTIONS AND ADDITIONAL INFORMATION PERTINENT TO THE COMPLETION OF AGENCY FORM Y

(All doses should be stated in rems)

1. Type or print the full name of the monitored individual in the order of last name

(include "Jr," "Sr," "III," etc.), first name, middle initial (if applicable).

2. Enter the individual's unique identification number, including punctuation. This number should preferably be the employee number (EN). If the EN is unavailable; enter the 9-digit social security number (SSN). If the individual has no social security number, enter the number from another official identification such as a passport or work permit.

3. Enter the code for the type of identification used as shown below:

Code ID Type

EN Employee Number

SSN U.S. Social Security Number

PPN Passport Number

WPN Work Permit Number

OTH Other

4. Check the box that denotes the sex of the individual being monitored.

5. Enter the date of birth of the individual being monitored in the format MM/DD/YYYY.

6. Enter the monitoring period for which this report is filed. The format should be MM/DD/YYYY - MM/DD/YYYY.

7. Enter the name of the licensee or facility not licensed by NRC that provided monitoring.

8. Enter the NRC license number or numbers.

9. Place an "X" in Record, Estimate, or No Record. Choose "Record" if the dose data listed represent a final determination of the dose received to the best of the licensee's knowledge. Choose "Estimate" only if the listed dose data are preliminary and will be superseded by a final determination resulting in a subsequent report. An example of such an instance would be dose data based on self-reading dosimeter results and the licensee intends to assign the record dose on the basis of TLD results that are not yet available.

10. Place an "X" in either Routine or “PSE” (Planned Special Exposure). Choose "Routine" if the data represent the results of monitoring for routine exposures. Choose "PSE" if the listed dose data represents the results of monitoring of planned special exposures received during the monitoring period. If more than one PSE was received in a single year, the licensee should sum them and report the total of all planned special exposures.

Part J, Agency Form Y Page 2 of 3

OF AGENCY FORM Y (Con’t.) All doses should be stated in rems

11. Enter the deep dose equivalent (DDE) to the whole body.

12. Enter the eye dose equivalent (LDE) recorded for the lens of the eye.

13. Enter the shallow dose equivalent recorded for the skin of the whole body (SDE, WB).

14. Enter the shallow dose equivalent recorded for the skin of the extremity receiving the maximum dose

(SDE, ME).

15. Enter the committed effective dose equivalent (CEDE).

16. Enter the committed dose equivalent (CDE) recorded for the maximally exposed organ.

17. Enter the committed dose equivalent (TEDE). The TEDE is the sum of items 11 and 15.

18. Enter the total organ dose equivalent (TODE) for the maximally exposed organ. The TODE is the sum of items 11 and 16.

19. Signature of the monitored individual.The signature of the monitored individual on this form indicates that the information contained on the form is complete and correct to the best of his or her knowledge.

20. [OPTIONAL] Enter the date this form was signed by the monitored individual.

21. Enter the name of the licensee or facility not licensed by the Agency providing monitoring for exposure to radiation (such as a VA facility) or the employer if the individual is not employed by the licensee and the employer chooses to maintain exposure records for its employees.

22. [OPTIONAL] Signature of the person designated to represent the licensee or employer entered in item

23. The licensee or employer who chooses to countersign the form should have on file documentation of all the information on the Agency Form 4 being signed.

24. [OPTIONAL] Enter the date this form was signed by the designated representative.

A PDF version Part J Appendix A Form Z is available here:

https://regulations.delaware.gov/AdminCode/title16/Division of Public Health/Health Systems Protection (HSP)/4465 Part J Appendix A Form Z (Replacement) 06.01.24.pdf

28 DE Reg. 312 (10/01/24)

INSTRUCTIONS AND ADDITIONAL INFORMATION PERTINENT TO THE COMPLETION OF AGENCY FORM Z

(All doses should be stated in rems)

1. Type or print the full name of the monitored individual in the order of last name

(include "Jr," "Sr," "III," etc.), first name, middle initial (if applicable).

2. Enter the individual's unique identification number, including punctuation. This number should preferably be the employee number (EN). If the EN is unavailable the 9-digit social security number (SSN). If the individual has no social security number, enter the number from another official identification such as a passport or work permit.

3. Enter the code for the type of identification used as shown below:

Code ID Type

EN Employee Number

SSN U.S. Social Security Number

PPN Passport Number

WPN Work Permit Number

OTH Other

4. Check the box that denotes the sex of the individual being monitored.

5. Enter the date of birth of the individual being monitored in the format MM/DD/YYYY.

6. Enter the monitoring period for which this report is filed. The format should be MM/DD/YYYY - MM/DD/YYYY.

7. Enter the name of the registered facility not licensed by NRC that provided monitoring.

8. Enter the registration number or numbers.

9. Place an "X" in Record, Estimate, or No Record. Choose "Record" if the dose data listed represent a final determination of the dose received to the best of the licensee's knowledge. Choose "Estimate" only if the listed dose data are preliminary and will be superseded by a final determination resulting in a subsequent report. An example of such an instance would be dose data based on self-reading dosimeter results and the licensee intends to assign the record dose on the basis of TLD results that are not yet available.

10. Place an "X" in either Routine or “PSE” (Planned Special Exposure). Choose "Routine" if the data represent the results of monitoring for routine exposures. Choose "PSE" if the listed dose data represents the results of monitoring of planned special exposures received during the monitoring period. If more than one PSE was received in a single year, the licensee should sum them and report the total of all planned special exposures.

Part J, Agency Form Z

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-1.0** General requirements {#sec-4465-1.0 omnilex-key=us-de-regs-official--title-16--4465-1.0}

1.1 No person shall use/operate a source of radiation or radiation facility who does not possess a valid certificate, license or registration issued or renewed to that person by the Agency in accordance with the regulations. Only a person who complies with the requirements of the regulations shall be entitled to receive or retain such a certificate, license or registration.

1.2 The owner/manager of a radiation facility shall designate a radiation safety officer (RSO) in accordance with the regulations.

1.3 All facility licenses, registrations and Radiation Technologist/Technician Certificates must be posted in a conspicuous location.

1.4 Any action taken by the Agency against an applicant or certificate, license or registration holder may be appealed to the Authority on Radiation Protection.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-2.0** Definitions {#sec-4465-2.0 omnilex-key=us-de-regs-official--title-16--4465-2.0}

“Applicant” means a person seeking a certificate, license or registration issued under the provisions of the Act and the requirements of the regulations.

“Certificate” is an official document issued by the Agency which authorizes a person to perform a specified radiation activity.

“Exemption” means an exclusion from a regulatory requirement granted by the Agency or Authority. When the exclusion is based on a national standard or similar documented and publicly available information, the Agency may grant it. Otherwise, the exemption shall be referred to the Authority for consideration.

“Hearing” means a proceeding to examine an application or other matter before the Authority in order to adjudicate rights, duties, or privileges.

“Imminent Radiation Hazard(s)” means an imminent hazard exists when the radiation levels that exist are in excess of 3 times the regulatory limit.

“License” means a license issued by the Agency in accordance with the regulations.

“Licensee” means any person who is licensed by the Agency in accordance with the regulations and the Act.

"Licensed practitioner" means an individual licensed to practice medicine, dentistry, podiatry, chiropractic, osteopathy, or veterinary medicine in this state. For the purpose of this regulation, advanced practice registered nurses (APRN) and physicians assistants (PAs) may order diagnostic or supportive X-ray procedures for patients in accordance with Title 24, Delaware Code. APRNs and PAs who supervise, perform, view, or interpret X-ray procedures do so within their scope of practice, as governed by Title 24, Delaware Code.

“Licensee's representative” means a person who has been authorized by the licensee to represent them during activities or proceedings governed by this regulation.

“Modification” means a change in the specification of a machine or radiation facility.

“Notice of violation” means a written statement of 1 or more alleged infringements of a legally binding requirement. The notice normally requires the licensee, registrant, other permit holder to provide a written statement describing the following:

corrective steps taken by the licensee, registrant, or other permit holder, and the results achieved;

corrective steps to be taken to prevent recurrence; and

the projected date for achieving full compliance. The Authority may require responses to notices of violation to be under oath.

“Qualified expert” means an individual who has demonstrated to the satisfaction of the Agency that such individual possesses the knowledge and training to measure ionizing radiation, to evaluate safety techniques, and to advise regarding radiation protection needs, for example, individuals certified in the appropriate field by the American Board of Radiology, or the American Board of Health Physics, or the American Board of Medical Physics, or those having equivalent qualifications. With reference to the calibration of radiation therapy equipment, an individual, in addition to the above qualifications, must be qualified in accordance with (Part X).

"Qualified medical physicist (QMP)" means an individual who meets each of the following credentials:

1. Has earned a master's and/or doctoral degree in physics, medical physics, biophysics, radiological physics, medical health physics, or equivalent disciplines from an accredited college or university; and

2. Has been granted certification in the specific subfield(s) of medical physics with its associated medical health physics aspects by an appropriate national certifying body and abides by the certifying body's requirements for continuing education; and/or

3. Is credentialed in accordance with Regulation 4465, Part X, Therapeutic Radiation machines, subsection 3.4, as amended.

“Registration” means to enroll or register with the Agency in accordance with the regulations.

“Regulations” mean all parts of the Delaware Radiation Control Regulations (DRCR) and all parts of the Delaware Radiation Technologist Certification Regulations (RTCR).

“Severity level” means a classification of violations based on relative seriousness of each violation and the significance of the effect of the violation on the occupational or public health or safety.

“Violation” means an infringement of any rule, certificate, license or registration condition, order of the agency, or any provision of the Act.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-3.0** Types of Certificates, Licenses or Registrations {#sec-4465-3.0 omnilex-key=us-de-regs-official--title-16--4465-3.0}

3.1 Certificate

3.1.1 A Radiation Technologist Certificate is required to practice radiation technology (Request Application Form ORC-R16) as outlined in the Delaware Radiation Technologist Certification Regulations.

3.1.2 A Plan Approval Certificate is required for the construction or modification of a radiation facility (Request Shielding Information Letter) as outlined in the regulations.

3.2 License. A Radioactive Material License is required to use and/or possess a radioactive material source (Request Application Form ORC-R2).

3.3 Registration

3.3.1 A registration is required to possess and/or use a radiation machine (i.e. X-ray equipment) or operate a radiation machine facility. (Request Application Form ORC-R1)

3.3.2 Registration is required to possess a source of radioactive material. (Request Application Form ORC-R2)

3.3.3 A registration is required to perform a radiation service including but not limited to, repair, install or calibrate radiation equipment/devices, perform health physics or radiation protection consultations or surveys, personnel dosimetry and therapeutic radiation physics (Request Application Form ORC-R3).

3.4 Annual/Biennial License or Registration

3.4.1 An annual or biennial license or registration shall be issued to any person desiring to possess, use, provide or operate a source of radiation, radiation facility or radiation service in the State for more than 30 days upon written application to the Agency.

3.4.2 The Agency shall issue a license or registration to the applicant if the Agency's inspection or examination reveals that the proposed facility, use, source of radiation and/or individual complies with the requirements of the regulations.

3.4.3 An annual/biennial license or registration is valid for 1 or 2 anniversary year(s) from the date of issuance, unless a new owner, management, firm or lessee takes possession of the facility, source of radiation or service; or the license or registration is revoked by the Authority for violations of the regulations. A license or registration is not transferable.

3.5 Temporary Use of Out of State Source

3.5.1 This license or registration allows for the temporary use of an out-of-state radiation source in Delaware.

3.5.2 X-ray equipment - send advance written notice to the Agency as per Part B.

3.5.3 Radioactive Material Source/Device - send advance written notice to the Agency of the intended use and location with photo copy of NRC or Agreement State License as per Part C.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-4.0** New Construction, Renovation, Change of Ownership, Management, Firm or Lessee {#sec-4465-4.0 omnilex-key=us-de-regs-official--title-16--4465-4.0}

4.1 A valid certificate, license or registration is not transferable. Therefore, it is the responsibility of the new owner/manager to acquire an operating certificate, license or registration prior to commencing operations.

4.2 New construction or modification of an existing room or area associated with a source of radiation requires plan approval in accordance with Regulation.

4.3 The owner/manager of a radiation source is responsible for notifying the Agency prior to its sale, transfer, lease, or disposal in accordance with requirements listed in Regulations Part B.

4.4 If any renovations or modifications of the physical structure of the existing facility are required, based on current or previous inspection reports of the Agency, the new owner/manager will be held responsible for these renovations or modifications.

4.4.1 Completion of any renovations shall be achieved prior to the start of operation, unless the new owner/manager is granted an exemption in accordance with Regulation 4465.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-5.0** Inspections {#sec-4465-5.0 omnilex-key=us-de-regs-official--title-16--4465-5.0}

5.1 Inspection Frequency

5.1.1 An inspection of a registered facility shall be performed at least every 2 years for medical facilities utilizing angiography, radiography, fluoroscopy, computed tomography (CT), mammography, stereotactic breast biopsy systems and radiation therapy modalities, and at least every 4 years for other registered facilities, including dental, bone densitometry, podiatry, veterinary, academic and industrial.

5.1.2 Additional inspections of registered facilities as described in the regulations shall be performed as often as necessary to ensure and verify compliance with the regulations.

5.2 Access

5.2.1 The Authority or its duly authorized representatives shall have the power to enter at all reasonable times upon any private or public property for the purpose of determining whether or not there is compliance with or violations of 16 Del.C., Ch.74 and rules and regulations issued thereunder, except that entry into areas under the jurisdiction of the federal government shall be effected only with the concurrence of the federal government or its duly authorized designated representative.

5.2.2 The Agency may suspend for a period not to exceed 30 days, the certificate, license or registration to operate/use a source of radiation for refusing access to the representative(s) of the Agency if the Agency can show good cause that there is a risk of imminent harm to the public from ionizing radiation at the facility to which the Agency is attempting access.

5.3 Inspection Report Form

5.3.1 Facility Inspection Form ORC-R11 shall be used to record the results of inspections at registered radiation source facilities as specified in (Part K), Compliance Procedures.

5.3.1.1 The co-signed original of the completed inspection report form shall be furnished to the person named on the license or registration or the radiation safety officer (RSO) at the conclusion of the inspection.

5.3.1.2 The completed inspection form shall list the violation(s) (if any), give the time period for correcting the violation(s) and state the corrections to be made. The inspection report form shall summarize the requirement(s) of the regulations.

5.3.1.3 The form shall also state that "Failure to comply with time limits for correction of any violations cited in this notice shall result in automatic license or registration suspension and immediate cessation of use of a source radiation or radiation area in accordance with Compliance Procedures of the regulations of the Authority on Radiation Protection."

5.3.2 The completed inspection report form is a public document that shall be made available for public disclosure to any person who requests it in accordance with the "Freedom of Information Act 29 Del.C., Ch. 100."

5.3.3 A Notice of Violation (Form ORC-R10) must be posted in a conspicuous location until the violation has been corrected.

5.4 Types of Inspections. Inspections are performed to verify compliance with all applicable laws and regulations.

5.4.1 Regular Inspections. Regular inspections are performed on a routine basis in permanent, operating, registered facilities. These inspections shall address all items on the inspection report form. Items in violation shall be recorded by item number.

5.4.2 Follow-up Inspections

5.4.2.1 Follow-up inspections shall be performed when a regular inspection finds 1 or more Severity Level 1 violation(s) or 3 or more Severity Level 2 violations.

5.4.2.2 Follow-up inspections may also be performed to verify proper posting of certificates, licenses or registrations, after complaint and investigation inspections, or after administrative hearings.

5.4.3 Complaint Inspections

5.4.3.1 Complaint inspections are performed in response to formal or informal complaints against registered facilities.

5.4.3.2 A complete inspection may be performed by the Agency in the interest of protecting the public.

5.4.4 Investigation Inspections. Investigation inspections are performed on non-registered radiation facilities for determining whether compliance with the regulations is required.

5.4.5 Other Inspections. Other inspections include construction/modification, pre-operational and other inspections not included above.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-6.0** Correction of Violations {#sec-4465-6.0 omnilex-key=us-de-regs-official--title-16--4465-6.0}

6.1 Violations of the regulations have been classified as Severity Level 1 and Severity Level 2 depending upon the impact of the violation.

6.1.1 Severity Level 1 violations generally could result in overexposure to the patient or operator or violate individual's rights as outlined in the regulations.

6.1.2 Severity Level 2 violations generally will not result in overexposure but may indicate a lack of administrative controls over the use of the radiation source. Reference Appendix A for violation classifications.

6.2 Severity Level 1 Items

6.2.1 When 1 or 2 Severity Level 1 items of violation are found by any inspection, the related source(s) of radiation shall be tagged "out-of-use." All violations shall be corrected prior to returning the unit in service.

6.2.2 When 3 or more Severity Level 1 items of violation are found by any inspection, the certificate, license or registration shall be suspended in accordance with Compliance Procedures. All violations shall be corrected prior to resuming registered activities.

6.2.3 The licensee or registrant shall inform the Agency in writing within 10 days of issuance of the inspection report of the proposed method or means of correcting the Severity Level 1 violation(s) and of the date when the correction will be made.

6.2.4 Follow-up inspections shall be conducted within 30 days to assure correction.

6.3 Severity Level 2 Items

6.3.1 All Severity Level 2 items shall be corrected as soon as possible, but in any event, within 60 days.

6.3.2 Follow-up inspections shall be conducted within 60 days to assure corrections have been completed.

6.4 If a follow-up inspection of a registered facility indicates non-compliance of a previously cited violation of the last inspection, a hearing before the Authority on Radiation Protection shall be scheduled. Additionally, the Agency may file a complaint to the Authority.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-7.0** Fees {#sec-4465-7.0 omnilex-key=us-de-regs-official--title-16--4465-7.0}

7.1 Radiation Machine Facility Permit Fees are established for issuance of annual registration permits to radiation machine facilities located within the State of Delaware, in accordance with 16 Del.C., Ch 74.

7.2 Fee Schedule

7.2.1 Category I: Facilities with a total of 5 or more of the medical modalities or non-medical modalities listed below: $1370.

7.2.2 Category II: Facilities with a total of 3 or 4 of the medical modalities or non-medical modalities listed below: $1030.

7.2.3 Category III: Facilities with 2 of the medical modalities listed below: $690.

7.2.4 Category IV: Facilities with 1 of the medical modalities listed below, and an annual patient workload of 750 examinations or more: $275.

7.2.5 Category V: Facilities with 1 of the medical modalities listed below, and an annual patient workload of less than 750 examinations, and all other radiation installations with 1 or 2 of the non-medical modalities listed below except as listed under Category VI: $140.

7.2.6 Category VI: Dental, podiatric, bone densitometry or veterinary installations: $75.

7.3 Fee Category Definitions

7.3.1 For purposes of the fee schedule set out in 7.2 above, the following definitions shall apply: “medical modalities” shall mean radiography, fluoroscopy, computed tomography, angiography, stereotactic breast biopsy systems, and radiation therapy, utilized on humans.

7.3.2 For purposes of the fee schedule set out in 7.2 above, the following definitions shall apply: “non-medical modalities” shall mean radiography, fluoroscopy, analytical equipment (including electron microscopes, fluorescence analysis and x-ray diffraction equipment), computed tomography, and particle accelerators, not utilized on humans.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-8.0** Procedure for Administrative Action by Agency {#sec-4465-8.0 omnilex-key=us-de-regs-official--title-16--4465-8.0}

8.1 If the Agency determines that condition(s) exist(s) in a registered facility which represent(s) a threat to life or a serious risk of damage to health, safety and welfare of the workers or public, or if serious violations, repeat violations, or general disregard of accepted radiation practice are found to exist, administrative action is required.

8.2 Compliance Conference. A meeting held by the Agency with management of a licensee, registrant, or other license, certificate or registration holder to discuss the following:

8.2.1 Safety, safeguards, or environmental problems;

8.2.2 Compliance with regulatory, license condition, or registration condition requirements;

8.2.3 Proposed corrective measures including, but not limited to, schedules for implementation; and

8.2.4 Enforcement options available to the agency.

8.3 Suspension of Certificate, License or Registration

8.3.1 Conditions for Suspension of Certificate, License or Registration

8.3.1.1 If some condition(s) is/are determined to exist in a registered facility which present(s) an imminent radiation hazard to human health, the Agency may cease operations of the source of radiation without a hearing or written notice until such time the conditions have been corrected.

8.3.1.2 Further enforcement action shall be taken in accordance with the regulations.

8.3.1.3 Such an imminent radiation hazard shall include, but is not limited to, any one of the following:

8.3.2 The suspension shall be effective upon receipt of written notice by the radiation safety officer or the person in charge of the radiation facility or their agent.

8.3.2.1 A suspension statement recorded on the inspection report by the Agency constitutes a written notice.

8.3.2.2 Service of a written notice of suspension by the Agency stating the reason(s) for the suspension must be made by the close of the following business day.

8.3.2.3 The certificate, license or registration shall not be suspended for a period longer than necessary to correct the hazardous conditions, unless mutually agreed upon.

8.4 Right of Appeal of Suspension

8.4.1 The owner/manager of the registered facility may submit in writing an appeal to the Authority on Radiation Protection for reconsideration of a decision by the Agency.

8.4.2 The notice of appeal shall be sent via certified mail to the Authority on Radiation Protection and to the Agency. An appeal shall not automatically stay the decision of the Agency.

8.4.3 After review for potential radiation hazard to the public, the suspended or revoked license or registration may be stayed on the order of the Program Administrator for Radiation Control.

8.4.4 If a notice of appeal is not filed within 30 days, the license or registration suspension or revocation recommendation shall be upheld and other enforcement action taken in accordance with the this regulation, subsection 9.4. If the notice of appeal is timely filed, the Authority on Radiation Protection shall hold a hearing at its earliest opportunity.

8.5 Reinstatement of Certificate, License or Registration

8.5.1 In consultation with the Authority on Radiation Protection, if a follow-up inspection by a representative of the Agency shows the imminent radiation hazard(s) to human health no longer exist(s), the suspension shall be lifted immediately and the certificate, license or registration returned.

8.5.2 If there is no evidence that the imminent radiation hazard(s) has/have been corrected, the suspension will remain in effect until the condition(s) has been corrected.

8.5.3 The owner/manager of the registered facility may request, in writing, a hearing before the Authority on Radiation Protection at any time during the period of suspension, for the purpose of demonstrating that the imminent radiation hazard(s) no longer exist.

8.5.4 The request for hearing shall not stay the suspension.

8.5.5 A record of all proceedings shall be made in accordance with Compliance Procedures.

8.6 Exemption Requests

8.6.1 All requests for exemptions must be filed with the Agency for review. If a determination cannot be made by the Agency, the exemption request must be referred to the Authority.

8.6.2 Agency may grant, an exemption if based on national standards.

8.6.3 Shall hear an appeal by the applicant within 10 days following the denial of an exemption request by the Agency. If an exemption is granted; record of the action shall become a part of the permanent record of the facility.

8.6.4 An exemption is not transferable.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-9.0** Administrative Action by the Authority {#sec-4465-9.0 omnilex-key=us-de-regs-official--title-16--4465-9.0}

9.1 Administrative Hearings

9.1.1 The Authority may, upon sworn complaint or upon its own initiative, cause an investigation to be held to determine whether a license or registration holder, former license or registration holder or applicant has engaged in any activity requiring disciplinary action.

9.1.2 Upon completion of said investigation, the Authority shall hold a hearing to determine whether a license or registration holder, former license or registration holder or applicant has engaged in activities specified in this section as grounds for disciplinary action.

9.1.3 The Authority shall fix the time and place for the hearing.

9.2 The Authority shall cause a copy of the charges, together with a notice of the time and place for the hearing, to be served on the alleged violator at least 30 days prior to the date fixed for the hearing. When personal service cannot be effected, the Agency shall mail a copy of the charges and of such notice to the alleged violator at his last known address according to the records of the Agency.

9.3 In all proceedings herein:

9.3.1 The alleged violator may be represented by counsel who shall have the right of examination and cross-examination.

9.3.2 The alleged violator and the Agency may call witnesses and admit documentary evidence on their own behalf.

9.3.3 Testimony before the Authority shall be under oath. Any member of the Authority shall have power to administer oaths for this purpose.

9.3.4 A record of the hearing shall be made. At the request and expense of either party such record shall be transcribed with a copy to the other party.

9.3.5 The decision of the Authority shall be based upon a preponderance of the evidence.

9.3.5.1 If the charges are supported by such evidence, the Authority may revoke, refuse to issue, or suspend a certificate, license or registration, or otherwise discipline the individual.

9.3.5.2 A suspended certificate, license or registration may be reissued upon a further hearing initiated at the request of the suspended licensee by written application in accordance with the rules of the Authority and if the Authority finds compliance has been achieved.

9.4 Revocation and Appeal of Suspended Certificate, License or Registration

9.4.1 The Authority on Radiation Protection, at its earliest opportunity, shall consider the Agency's recommendation for certificate, license or registration revocation or hear an appeal by the owner/manager whose permit stands suspended.

9.4.2 The Authority on Radiation Protection shall, at each scheduled meeting, release the name(s) and address(es) of those registered facilities currently meeting the following criteria:

9.4.3 Certificate, License or Registration permanently revoked

9.4.4 Certificate, License or Registration suspended

9.4.5 Certificate, License or Registration censored

9.4.6 Issued a letter of reprimand

9.4.7 Certificate, License or Registration application refused

9.4.8 Certificate, License or Registration renewal refused

9.4.9 Use of source of radiation terminated

9.5 Exemptions referred to the Authority

9.5.1 The Authority on Radiation Protection:

9.5.2 May from time to time grant written permission to vary from particular provisions set forth in the regulations when the extent of the variation is clearly specified and it is documented to the Authority's satisfaction that:

9.5.2.1 Such variation is necessary to obtain a beneficial use by the owner/manager of an existing facility;

9.5.2.2 Appropriate alternative measures have been taken to protect the health and safety of the public from ionizing radiation and assure that the purpose of the provisions from which the variation is sought will be observed.

9.5.3 The Authority shall hear an appeal by the applicant within 30 days following the denial of an exemption request by the Agency. If an exemption is granted; record of the action shall become a part of the permanent record of the facility.

9.5.4 An exemption is not transferable.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-10.0** Agency Emergency Actions {#sec-4465-10.0 omnilex-key=us-de-regs-official--title-16--4465-10.0}

10.1 Inspection/Enforcement

10.1.1 A registered facility may be inspected by the Agency as often as necessary for enforcement of the regulations.

10.1.2 Registered facilities, their employees and their agents shall be in compliance with the regulations.

10.1.3 The established administrative procedures for the implementation and enforcement of the provisions and penalties of 16 Del.C., Ch, 74, shall be applicable to this section.

10.2 Failure to allow access, inspection or tests by the Agency representative(s) shall cause the Agency to prohibit the use of a source of radiation, close the registered facility, and/or suspend the facility certificate, license or registration if the Agency can show good cause to believe that there is a risk of immediate harm to the public from ionizing radiation at the facility to which the Agency is attempting access.

10.3 Procedure when Overexposure/Radiation Contamination is Suspected:

10.3.1 When the Agency has reasonable cause to suspect possible individual overexposure or radioactive contamination at a registered facility in excess of limits set forth in regulation Part D it may conduct a radiation investigation which can indicate exposure histories of individuals or make any other investigations as indicated and shall take appropriate action.

10.3.2 The Agency may require any or all of the following measures:

10.3.2.1 The immediate closing of the registered facility or prohibition of the use of a radiation source or radiation area until, in the opinion of the Agency, no further danger of overexposure or contamination exists.

10.3.2.2 Restriction of an employee(s) services to some area of the radiation facility where there would be no opportunity to use a source of radiation or be irradiated.

10.3.2.3 Any other action which the Agency can demonstrate is necessary to protect the health of the public and other employees of the radiation facility.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-11.0** Court Penalties {#sec-4465-11.0 omnilex-key=us-de-regs-official--title-16--4465-11.0}

11.1 Any person who violates a provision of the regulations and any person who is the holder of a certificate, license or registration or who otherwise operates a registered facility that does not comply with the requirements of the regulations shall be subject to the provisions of 16 Del.C. section 7416.

11.2 Operation without a Certificate, License or Registration. If a facility or individual is found operating without a valid certificate, license or registration as required by Regulation Part B, the Agency may act on behalf of the Authority and the source of radiation shall be tagged out-of-use.

11.3 The Agency may seek to enjoin violations of the regulations.

11.4 A conspicuous notice shall be prominently displayed on the radiation source or at all entrances of facilities meeting the following criteria:

11.4.1 Failed to obtain a valid certificate, license or registration; or

11.4.2 Certificate, License or Registration suspended; or

11.4.3 Certificate, License or Registration revoked.

Violation Classification (Typical/Not all inclusive)

Radiation Source Facility

Severity Level 1

Severity Level 2

1.

Operating without a permit

1.

Registration Form

2.

Personnel Overexposure

2.

Notice to Employees

3.

Radiation Levels Excessive

3.

Safety Procedures

4.

Personnel Monitoring

4.

Personnel Monitoring Records

Medical Uses

Severity Level 1

Severity Level 2

1.

Patient exposure (ESE)

12.

2.

Tube support

13.

Maintenance of x-ray system records

3.

Technique indicators

14.

Speed of film/screen

4.

Multiple tube indication

15.

Technique chart

5.

Gonadal shielding

16.

Warning label

6.

Operator apron/barrier

17.

Patient dose of 1 gray (100 rads) or more not reported to the Agency

Radiographic

Severity Level 1

Severity Level 2

1.

Location of x-ray controls

1.

Visual/audio signal

2.

Position indicating device

2.

Adjustment of X-ray field

3.

Beam Collimation

3.

Indication of field size, upon adjustments,

4.

Filtration deficiency of 0.2+ mm

4.

Means to limit source to skin distance

5.

Variation in timer linearity of 15% or more

5.

Filtration deficiency of 0.2 mm or less

6.

Variation in exposure reproducibility of 15% or more

6.

Variation in timer reproducibility linearity more that 10% but less than 15%

7.

Total misalignment of X-ray/light field edges of 5% or more

7.

Variation in exposure reproducibility more than 5% but less than 10%

8.

Total misalignment of X-ray beam/image receptor centers of 5% or more )

8.

Total misalignment of light/X-ray field edges more than 2% but less than 5%

9.

Discorrespondence of indicated X-ray field with beam limited X-ray field of 5% or more

9.

Total misalignment of X-ray beam/image receptor centers more than 2% but less than 5%

10.

Discorrespondence of indicated X-ray with beam limited X-ray field more than 2% but less than 5%

Fluoroscopic

Severity Level 1

Severity Level 2

1.

Activation of X-ray production

1.

Posting of exposure rate measurements

2.

Annual exposure rate measurement

2.

Measurement records and posting of same

3.

Exposure rate

3.

Adjustment of field

4.

Useful beam protective barrier

4.

Means of field adjustment

5.

Limitation of X-ray field to image receptor

5.

Indication of kV and mA

6.

Minimum field at maximum SID

6.

Means to indicate that beam is perpendicular to image receptor

7.

High level control exposure rate limit

7.

Audible signal to reset

8.

Timing device

8.

Minimum source to skin distance

9.

Control of scattered radiation

9.

Exposure rate due to transmission through primary barrier

10.

Failure to report patient dose of 1+ gray to the Agency

Industrial Radiographic

Severity Level 1

Severity Level 2

1. > 2 mR/hr.

Failure to maintain radiation level from device < 4" in diameter below maximum allowable limit of 50 mR/hr. at 6"

< 2 mR/hr.

2. > 2 mR/hr.

Failure to maintain radiation level from device > 4" diameter below maximum allowable limit of 200 mR/hr. at surface

< 2 mR/hr.

3. > 2 mR/hr.

Failure to maintain radiation level from storage container below maximum allowable limit of 200 mR/hr. at the surface

< 2 mR/hr.

4. > 2 mR/hr.

Failure to maintain radiation level from storage container below maximum allowable limit of 10 mR/hr. at a distance of 1 meter

< 2 mR/hr.

Locking of Source

5.

Radiation Source Storage Container was found unlocked and not under the direct surveillance of authorized individual

6.

Exposure device and/or storage container was not locked during transit or prior to unit being made secure

7.

Device was not physically secured to prevent tampering or removal

Survey Instruments

Severity Level 1

Severity Level 2

1.

Failure to adequately maintain survey instruments

1.

Failure to possess calibrated back up instrument

2.

Survey meter not capable of detecting 2-1000 mR/hr.

2.

Failure to conduct quarterly calibrations

3.

Failure to calibrate unit after servicing

4.

Failure to achieve accuracy of (+ 20%)

5.

Failure to calibrate each scale using 2 points other than zero

6.

Failure to maintain calibration records for 2 years

Leak Testing/Repair

Severity Level 1

Severity Level 2

1.

Service to sealed source not conducted by authorized individual

1.

Failure to conduct leak test within 6 month interval

2.

Failure to immediately withdraw contaminated unit from service to effect decontamination/repair

2.

Leak test procedure not capable of detecting unit 0.005 uCi of removable contamination

3.

Failure to properly label unsecured source

3.

Failure to record test results in microcuries

4.

Failure to notify agency within 5 days of receiving test results

Inventory/Inspection

Severity Level 1

Severity Level 2

1.

Failure to perform quarterly operational safety maintenance and inspection

1.

Failure to conduct quarterly inventory

2.

Failure to withdraw defective unit from service

2.

Failure to maintain utilization log

3.

Failure to conduct and record alarm tests at the beginning of each period of use

3.

Failure to log required information

4.

Failure to properly document quarterly inspection and maintenance of radiation devices

5.

Failure to record and maintain test results

Limitations/Procedures/Controls

Severity Level 1

Severity Level 2

1.

Individual is not qualified Industrial Radiographer

1.

Failure to maintain training and test records

2.

Individual is not a qualified radiographer's assistant trainee

2.

Failure to record dosimetry data

3.

Qualified operator(s) not wearing personal monitoring devices

4.

Operating and Emergency procedures do not meet the requirements

Precautionary Procedures

Severity Level 1

Severity Level 2

1.

Failure of qualified operators to maintain direct surveillance

1.

Failure to post required information

2.

Failure to have calibrated and operable survey instrument available

2.

Failure to maintain survey records for 2 years

3.

Failure to conduct physical radiation survey

4.

Failure to maintain records at temporary job site

Special Requirements

Severity Level 1

Severity Level 2

1.

Failure to meet requirements for enclosed radiography

1.

Failure to maintain evaluation records for 2 years

2.

Failure to meet exemption requirements and maintain unit

Analytical

Severity Level 1

Severity Level 2

1.

Failure to provide safety device

1.

Failure to label equipment

2.

Failure to provide warning devices

2.

Failure to have appropriate warning lights

3.

Failure to install shutter

3.

Failure to provide protective cabinet to prevent leakage

4.

Failure to construct tube housing in manner which ensures compliance

4.

Failure to conduct Radiation Surveys

5.

Failure to obtain radiation safety officer's approval for by-passing safety device

5.

Failure to document survey record

6.

Failure to provide and/or ensure the use of extremity dosimeters

6.

Failure to post area

7.

Failure to instruct and/or ensure operator competence

7.

Failure to secure unused ports

Particle Accelerators

Limitations

Severity Level 1

Severity Level 2

1.

Operator did not receive radiation safety instruction or could not demonstrate understanding of radiation safety

1.

Operator had not received copies

2.

Operator unable to demonstrate competency in the use of the accelerator

2.

Radiation Safety Committee/Radiation Safety Officer is not authorized to terminate operations

Controls/Interlocks

Severity Level 1

Severity Level 2

1.

HRA not provided with Interlock

1.

Instrumentation and controls are not clearly identified

2.

Interlock does not require manual reset

2.

Scram buttons do not require manual reset

3.

Safety interlocks not independently wired

3.

Not all HRA entrances are equipped with warning lights

4.

All safety interlocks are not fail safe

4.

Not all HRA are equipped with audible warning devices which activate for 15 seconds

5.

Scram buttons not located in HRA

5.

HRA barriers/pathways are not identified

Operating Procedures

Severity Level 1

Severity Level 2

1.

Particle accelerator not unsecured from unauthorized use

2.

Bypass of safety interlock not authorized by radiation safety officer and/or Radiation Safety Committee or not recorded and posted

2.

Safety interlocks are used as routine "off" switch

3.

Electrical circuit diagram not maintained and available

4.

Current operating and emergency procedures are not kept at control panel

5.

Record of quarterly safety device operability check are not available

Radiation Monitoring

Severity Level 1

Severity Level 2

1.

Radiation protection survey not performed and/or documented by an approved person following operation or facility changes

1.

Portable monitoring equipment not available, operable and calibrated

2.

Radiation levels not continuously monitored in all HRAs

2.

All area monitors are not calibrated annually

3.

Periodic surveys of airborne particulates are not performed

4.

Periodic Smear Surveys are not conducted for contamination

5.

All area surveys are not performed according to proper written procedures

6.

Current records of all surveys and tests were not available at facility

Ventilation Systems

Notice and Reports to Workers

Posting of Notices

Severity Level 1

Severity Level 2

1.

2.

Facility radiation permit/document not posted

3.

Radiation operating procedures not posted

4.

Notice of violation for radiological working conditions not posted

5.

Notice to employees, Agency Form X not posted

6.

7.

Instructions to Workers

Severity Level 1

Severity Level 2

1.

1.

Workers were not kept informed of radiation sources

2.

Workers were not instructed about warnings for unusual occurrence or malfunction that may involve exposure to radiation

2.

Workers were not instructed of health protection problems associated with radiation exposure

3.

Workers were not advised of radiation exposure reports

3.

Workers were not instructed to observe applicable parts of DRCR

Notifications

Severity Level 1

Severity Level 2

1.

Written report of specified Radiation exposure data are not given to the worker

1.

Workers are not advised annually of their radiation exposure

2.

Workers are not furnished a radiation exposure report within 30 days after the licensee becomes informed of exposure or termination of employment

2.

As required pursuant to Part D, Sections 46.0, 47.0 and 48.0 exposed individuals are not provided a report of their radiation exposure

Representatives of Registrant/Workers

Severity Level 1

1.

Agency not afforded opportunity to inspect equipment and activities

2.

Agency not permitted to consult with workers privately

3.

Worker authorized representative not given opportunity to accompany agency during inspection of physical working conditions

4.

Worker representative does not meet qualifications set forth in routine radiation

5.

Different facility/worker representatives not permitted to accompany agency on inspection

6.

Mutually agreed upon "outside" individual(s) was not permitted to accompany agency inspectors

7.

Worker(s) was not allowed to privately consult with the Agency inspector about perceived radiological condition

8.

A worker has been discharged or discriminated against for filing a radiological complaint on behalf of himself or others

Therapeutic Radiation Machines

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-1.0** Scope and Purpose {#sec-4465-1.0 omnilex-key=us-de-regs-official--title-16--4465-1.0}

1.1 This Part establishes requirements, for which the registrant is responsible, for use of therapeutic radiation machines. The provisions of this Part are in addition to, and not in substitution for, other applicable provisions of the regulations.

1.2 The use of therapeutic radiation machines shall be by, or under the supervision of, a licensed practitioner who is also a physician, and who meets the training/experience criteria established by Part X, Section 3.0, as applicable.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-2.0** Definitions {#sec-4465-2.0 omnilex-key=us-de-regs-official--title-16--4465-2.0}

As used in this regulation, the following definitions apply:

"Absorbed dose (D)" means the mean energy imparted by ionizing radiation to matter. Absorbed dose is determined as the quotient of dE by dM, where dE is the mean energy imparted by ionizing radiation to matter of mass dM. The SI unit of absorbed dose is joule per kilogram and the special name of the unit of absorbed dose is the gray (Gy). The previously used special unit of absorbed dose (rad) is being replaced by the gray.

“Conventional simulator” means any X-ray system designed to reproduce the geometric conditions of the radiation therapy equipment.

“Detector” (See "radiation detector").

“Dose monitor unit (DMU)” means a unit response from the beam monitoring system from which the absorbed dose can be calculated.

“Electronic brachytherapy” means a method of radiation therapy where an electrically generated source of ionizing radiation is placed in or near the tumor or target tissue to deliver therapeutic radiation dosage.

“Electronic brachytherapy device” means the system used to produce and deliver therapeutic radiation including the X-ray tube, the control mechanism, the cooling system, and the power source.

“Electronic brachytherapy source” means the X-ray tube component used in an electronic brachytherapy device.

“External beam radiation therapy” means therapeutic irradiation in which the source of radiation is at a distance from the body.

“Field‑flattening filter” means a filter used to homogenize the absorbed dose rate over the radiation field.

“Filter” means material placed in the useful beam to change beam quality in therapeutic radiation machines subject to 6.4.

“Gray (Gy)” means the SI unit of absorbed dose, kerma, and specific energy imparted equal to 1 joule per kilogram. The previous unit of absorbed dose (rad) is being replaced by the gray [1 Gy=100 rad].

“Half‑value layer (HVL)” means the thickness of a specified material which attenuates X‑radiation or gamma radiation to an extent such that the air kerma rate, exposure rate or absorbed dose rate is reduced to 1/2 of the value measured without the material at the same point.

“Intensity Modulated Radiation Therapy (IMRT)” means radiation therapy that uses non-uniform radiation beam intensities which have been determined by various computer-based optimization techniques.

“Interlock” means a device preventing the start or continued operation of equipment unless certain predetermined conditions prevail.

“Interruption of irradiation” means the stopping of irradiation with the possibility of continuing irradiation without resetting of operating conditions at the control panel.

“Irradiation” means the exposure of a living being or matter to ionizing radiation.

“Isocenter” means the center of the sphere through which the useful beam axis passes while the gantry moves through its full range of motions.

“Kilovolt (kV) [kilo electron volt (keV)]” means the energy equal to that acquired by a particle with 1 electron charge in passing through a potential difference of 1000 volts in a vacuum. [Note: current convention is to use kV for photons and keV for electrons.]

“Lead equivalent” means the thickness of the material in question affording the same attenuation, under specified conditions, as lead.

“Leakage radiation” means radiation emanating from the radiation therapy system except for the useful beam.

“Licensed practitioner” means an individual licensed to practice medicine, dentistry, podiatry, chiropractic, osteopathy, or veterinary medicine in this state. For the purpose of this regulation, advanced practice registered nurses (APRN) and physicians assistants (PA) may order diagnostic or supportive X-ray procedures for patients in accordance with Title 24, Delaware Code. APRNs and PAs who supervise, perform, view, or interpret X-ray procedures do so within their scope of practice, as governed by Title 24, Delaware Code.

“Light field” means the area illuminated by light, simulating the radiation field.

“mA” means milliampere.

“Megavolt (MV) [mega electron volt (MeV)]” means the energy equal to that acquired by a particle with 1 electron charge in passing through a potential difference of 1 million volts in a vacuum. [Note: current convention is to use MV for photons and MeV for electrons.]

“Misadministration” means an event that meets the criteria in 5.2.

“Mobile electronic brachytherapy service” means transportation of an electronic brachytherapy device to provide electronic brachytherapy at an address that is not the address of record.

“Monitor unit (MU)” (See "dose monitor unit").

“Moving beam radiation therapy” means radiation therapy with any planned displacement of radiation field or patient relative to each other, or with any planned change of absorbed dose distribution. It includes arc, skip, conformal, intensity modulation and rotational therapy.

“Nominal treatment distance” means:

a. For electron irradiation, the distance from the scattering foil, virtual source, or exit window of the electron beam to the entrance surface of the irradiated object along the central axis of the useful beam.

b. For X‑ray irradiation, the virtual source or target to isocenter distance along the central axis of the useful beam. For non‑isocentric equipment, this distance shall be that specified by the manufacturer.

“Patient” means an individual subjected to machine produced radiation for the purposes of medical therapy.

“Peak tube potential” means the maximum value of the potential difference across the X‑ray tube during an exposure.

“Periodic quality assurance check” means a procedure which is performed to ensure that a previous parameter or condition continues to be valid.

“Phantom” means an object behaving in essentially the same manner as tissue, with respect to absorption or scattering of the ionizing radiation in question.

“Practical range of electrons” corresponds to classical electron range where the only remaining contribution to dose is from bremsstrahlung X‑rays. A further explanation may be found in "Clinical Electron Beam Dosimetry: Report of AAPM Radiation Therapy Committee Task Group 25" [Medical Physics 18(1): 73‑109, Jan/Feb. 1991] and ICRU Report 35, "Radiation Dosimetry: Electron Beams with Energies Between 1 and 50 MeV", International Commission on Radiation Units and Measurements, September 15, 1984.

“Prescribed dose” means the total dose and dose per fraction as documented in the written directive. The prescribed dose is a estimation from measured data from a specified therapeutic machine using assumptions that are clinically acceptable for that treatment technique and historically consistent with the clinical calculations previously used for patients treated with the same clinical technique.

“Primary dose monitoring system” means a system which will monitor the useful beam during irradiation and which will terminate irradiation when a pre‑selected number of dose monitor units have been delivered.

“Primary protective barrier” (see "protective barrier").

“Protective barrier” means a barrier of radiation absorbing material(s) used to reduce radiation exposure. The types of protective barriers are as follows:

a. "Primary protective barrier" means the material, excluding filters, placed in the useful beam.

b. "Secondary protective barrier" means the material which attenuates stray radiation.

“Qualified expert” means an individual who has demonstrated to the satisfaction of the Agency that such individual possesses the knowledge and training to measure ionizing radiation, to evaluate safety techniques, and to advise regarding radiation protection needs, for example, individuals certified in the appropriate field by the American Board of Radiology, or the American Board of Health Physics, or the American Board of Medical Physics, or those having equivalent qualifications. With reference to the calibration of radiation therapy equipment, an individual, in addition to the above qualifications, must be qualified in accordance with 4465 Part F and 4465 Part X of these regulations as amended.

“Qualified Medical Physicist (QMP)” means an individual who meets each of the following credentials:

1. Has earned a master's and/or doctoral degree in physics, medical physics, biophysics, radiological physics, medical health physics, or equivalent disciplines from an accredited college or university; and

2. Has been granted certification in the specific subfield(s) of medical physics with its associated medical health physics aspects by an appropriate national certifying body and abides by the certifying body's requirements for continuing education; and/or

3. Is credentialed in accordance with Regulation 4465, Part X, Therapeutic Radiation machines, subsection 3.4, as amended.

“Radiation detector” means a device which, in the presence of radiation provides, by either direct or indirect means, a signal or other indication suitable for use in measuring one or more quantities of incident radiation.

“Radiation field” (see "useful beam").

“Radiation head” means the structure from which the useful beam emerges.

"Radiation Therapist" means an individual who is certified and registered by the American Registry of Radiologic Technologists in Radiation Therapy and who has successfully completed an accredited radiation therapy educational program.

“Redundant beam monitoring system” means a combination of 2 independent dose monitoring systems in which each system is designed to terminate irradiation in accordance with a pre‑selected number of dose monitor units.

“Scattered radiation” means ionizing radiation emitted by interaction of ionizing radiation with matter, the interaction being accompanied by a change in direction of the radiation. Scattered primary radiation means that scattered radiation which has been deviated in direction only by materials irradiated by the useful beam.

“Secondary dose monitoring system” means a system which will terminate irradiation in the event of failure of the primary dose monitoring system.

“Secondary protective barrier” (see "protective barrier").

“Shadow tray” means a device attached to the radiation head to support auxiliary beam blocking material.

“Shutter” means a device attached to the tube housing assembly which can totally intercept the useful beam and which has a lead equivalency not less than that of the tube housing assembly.

“Sievert (Sv)” means the SI unit of dose equivalent. The unit of dose equivalent is the joule per kilogram. The previous unit of dose equivalent (rem) is being replaced by the sievert. [1 Sv=100 rem.]

“Simulator (radiation therapy simulation system)” means any X‑ray system intended for localizing the volume to be exposed during radiation therapy and establishing the position and size of the therapeutic irradiation field. [See: Conventional Simulator and Virtual Simulator.]

“Source” means the region and/or material from which the radiation emanates.

“Source‑skin distance (SSD)” (see "target‑skin distance").

“Stationary beam radiation therapy” means radiation therapy without displacement of 1 or more mechanical axes relative to the patient during irradiation.

“Stray radiation” means the sum of leakage and scattered radiation.

“Target” means that part of an X‑ray tube or accelerator onto which a beam of accelerated particles is directed to produce ionizing radiation or other particles.

“Target‑skin distance (TSD)” means the distance measured along the beam axis from the center of the front surface of the X‑ray target and/or electron virtual source to the surface of the irradiated object or patient.

“Tenth‑value layer (TVL)” means the thickness of a specified material which attenuates X‑radiation or gamma radiation to an extent such that the air kerma rate, exposure rate, or absorbed dose rate is reduced to 1/10 of the value measured without the material at the same point.

“Termination of irradiation” means the stopping of irradiation in a fashion which will not permit continuance of irradiation without the resetting of operating conditions at the control panel.

“Therapeutic radiation machine” means X‑ray or electron‑producing equipment designed and used for external beam radiation therapy. For the purpose of this regulation, devices used to administer electronic brachytherapy shall also be considered therapeutic radiation machines.

“Tube” means an X‑ray tube, unless otherwise specified.

“Tube housing assembly” means the tube housing with tube installed. It includes high‑voltage and/or filament transformers and other appropriate elements when such are contained within the tube housing.

“Useful beam” means the radiation emanating from the tube housing port or the radiation head and passing through the aperture of the beam limiting device when the exposure controls are in a mode to cause the therapeutic radiation machine to produce radiation.

“Virtual Simulator” means a computed tomography (CT) unit used in conjunction with relevant software which recreates the treatment machine; and that allows import, manipulation, display, and storage of images from CT and/or other imaging modalities.

“Virtual source” means a point from which radiation appears to originate.

“Wedge filter” means a filter which effects continuous change in transmission over all or a part of the useful beam.

“Written directive” means an order in writing for the administration of radiation to a specific patient or human research subject, as specified in 5.1.

“X‑ray tube” means any electron tube which is designed to be used primarily for the production of X‑rays.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-3.0** General Administrative Requirements for Facilities Using Therapeutic Radiation Machines. {#sec-4465-3.0 omnilex-key=us-de-regs-official--title-16--4465-3.0}

3.1 Administrative Controls. The registrant shall be responsible for directing the operation of the therapeutic radiation machines that have been registered with the Agency. The registrant or the registrant's agent shall ensure that the requirements of Part X are met in the operation of the therapeutic radiation machine(s).

3.2 A therapeutic radiation machine that does not meet the provisions of these regulations shall not be used for irradiation of patients.

3.3 Training for Therapeutic Radiation Machine Authorized Users. The registrant for any therapeutic radiation machine subject to 6.0 or 7.0 shall require the authorized user to be a physician who:

3.3.1 Is certified in:

3.3.1.1 Radiation oncology or therapeutic radiology by the American Board of Radiology or Radiology (combined diagnostic and therapeutic radiology program) by the American Board of Radiology prior to 1976; or

3.3.1.2 Radiation oncology by the American Osteopathic Board of Radiology; or

3.3.1.3 Radiology, with specialization in radiotherapy, as a British "Fellow of the Faculty of Radiology" or "Fellow of the Royal College of Radiology"; or

3.3.1.4 Therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; or

3.3.2 Is in the active practice of therapeutic radiology, and has completed 200 hours of instruction in basic radiation techniques applicable to the use of an external beam radiation therapy unit, 500 hours of supervised work experience, and a minimum of 3 years of supervised clinical experience.

3.3.2.1 To satisfy the requirement for instruction, the classroom and laboratory training shall include:

3.3.2.1.1 Radiation physics and instrumentation;

3.3.2.1.2 Radiation protection;

3.3.2.1.3 Mathematics pertaining to the use and measurement of ionization radiation; and

3.3.2.1.4 Radiation biology.

3.3.2.2 To satisfy the requirement for supervised work experience, training shall be under the supervision of an authorized user and shall include:

3.3.2.2.1 Review of the full calibration measurements and periodic quality assurance checks;

3.3.2.2.2 Evaluation of prepared treatment plans and calculation of treatment times/patient treatment settings;

3.3.2.2.3 Using administrative controls to prevent misadministrations;

3.3.2.2.4 Implementing emergency procedures to be followed in the event of the abnormal operation of an external beam radiation therapy unit or console; and

3.3.2.2.5 Checking and using radiation survey meters.

3.3.2.3 To satisfy the requirement for a period of supervised clinical experience, training shall include 1 year in a formal training program approved by the Residency Review Committee for Radiology of the Accreditation Council for Graduate Medical Education or the Committee on Postdoctoral Training of the American Osteopathic Association and an additional 2 years of clinical experience in therapeutic radiology under the supervision of an authorized user. The supervised clinical experience shall include:

3.3.2.3.1 Examining individuals and reviewing their case histories to determine their suitability for external beam radiation therapy treatment, and any limitations/contraindications;

3.3.2.3.2 Selecting proper dose and how it is to be administered;

3.3.2.3.3 Calculating the therapeutic radiation machine doses and collaborating with the authorized user in the review of patients' progress and consideration of the need to modify originally prescribed doses and/or treatment plans as warranted by patients' reaction to radiation; and

3.3.2.3.4 Post‑administration follow‑up and review of case histories.

3.3.3 Notwithstanding the requirements of subsections 3.31 and 3.3.2 the registrant for any therapeutic radiation machine subject to 6.0 may also submit the training of the prospective authorized user physician for Agency review on a case‑by‑case basis.

3.3.4 A physician shall not act as an authorized user for any therapeutic radiation machine until such time as said physician's training has been reviewed and approved by the Agency.] 2*/

3.4 Training for Qualified Medical Physicist. The registrant for any therapeutic radiation machine subject to 6.0 or 7.0 shall require the Qualified Medical Physicist to:

3.4.1 Be registered with the Agency, under the provisions of Part B of this regulation, as a provider of radiation services in the area of calibration and compliance surveys of external beam radiation therapy units; and

3.4.2 Be certified by the American Board of Radiology in:

3.4.2.1 Therapeutic medical physics; or

3.4.2.2 Diagnostic medical physics; or

3.4.2.3 Nuclear medical physics; or

3.4.2.4 Radiological physics; or

3.4.2.5 Be certified by the American Board of Medical Physics in Radiation Oncology Physics; or

3.4.2.6 Be certified by the Canadian College of Medical Physics; or

3.4.2.7 Hold a master's or doctor's degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university, and have completed 1 year of full time training in medical physics and an additional year of full time work experience under the supervision of a Qualified Medical Physicist at a medical institution. This training and work experience shall be conducted in clinical radiation facilities that provide high-energy external beam radiation therapy (photons and electrons with energies greater than or equal to one MV/one MeV). To meet this requirement, the individual shall have performed the tasks listed in 4.1, 6.16, 7.20 and 6.16, 7.21 under the supervision of a Qualified Medical Physicist during the year of work experience.

3.5 Qualifications of Operators.

3.5.1 Individuals who will be operating a therapeutic radiation machine for medical use shall be state certified, American Registry of Radiologic Technologists (ARRT) registered radiation therapists.4/

3.5.2 The names and training of all personnel currently operating a therapeutic radiation machine shall be kept on file at the facility. Information on former operators shall be retained for a period of at least 2 years beyond the last date they were authorized to operate a therapeutic radiation machine at that facility.]

3.6 Written safety procedures and rules shall be developed by a Qualified Medical Physicist and shall be available in the control area of a therapeutic radiation machine, including any restrictions required for the safe operation of the particular therapeutic radiation machine. The operator shall be able to demonstrate familiarity with these rules.

3.7 Individuals shall not be exposed to the useful beam except for medical therapy purposes and unless such exposure has been ordered in writing by a therapeutic radiation machine authorized user. This provision specifically prohibits deliberate exposure of an individual for training, demonstration or other non‑healing‑arts purposes.

3.8 Visiting Authorized User. Notwithstanding the provisions of 3.7 a registrant may permit any physician to act as a visiting authorized user under the term of the registrant's Certificate of Registration for up to 60 days per calendar year under the following conditions:

3.8.1 The visiting authorized user has the prior written permission of the registrant's management and, if the use occurs on behalf of an institution, the institution's Radiation Safety Committee (where applicable); and

3.8.2 The visiting authorized user meets the requirements established for authorized user(s) in 3.3.1 and 3.3.2; and

3.8.3 The registrant shall maintain copies of the written permission required in 3.8.1 and documentation that the visiting authorized user met the requirements of 3.8.2 for 5 years from the date of the last visit.

3.9 All individuals associated with the operation of a therapeutic radiation machine shall be instructed in and shall comply with the provisions of the registrant's quality management program. In addition to the requirements of Part X, these individuals are also subject to the requirements of Part D, Sections 45.0, 17.0, and 37.0 of this regulation.

3.10 Information and Maintenance Record and Associated Information. The registrant shall maintain the following information in a separate file or package for each therapeutic radiation machine, for inspection by the Agency:

3.10.1 Report of acceptance testing;

3.10.2 Records of all surveys, calibrations, and periodic quality assurance checks of the therapeutic radiation machine required by Part X, as well as the name(s) of person(s) who performed such activities;

3.10.3 Records of maintenance and/or modifications performed on the therapeutic radiation machine, as well as the name(s) of person(s) who performed such services;

3.10.4 Signature of person authorizing the return of therapeutic radiation machine to clinical use after service, repair, or upgrade.

3.11 Records Retention. All records required by Part X shall be retained until disposal is authorized by the Agency unless another retention period is specifically authorized in Part X. All required records shall be retained in an active file from at least the time of generation until the next Agency inspection. Any required record generated prior to the last Agency inspection may be microfilmed or otherwise archived as long as a complete copy of said record can be retrieved until such time as the Agency authorizes final disposal.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-4.0** General Technical Requirements for Facilities Using Therapeutic Radiation Machines. {#sec-4465-4.0 omnilex-key=us-de-regs-official--title-16--4465-4.0}

4.1 Protection Surveys

4.1.1 The registrant shall ensure that radiation protection surveys of all new facilities, and existing facilities not previously surveyed are performed with an operable radiation measurement survey instrument calibrated in accordance with 8.0. The radiation protection survey shall be performed by, or under the direction of, a Qualified Medical Physicist or a qualified expert and shall verify that, with the therapeutic radiation machine in a "BEAM‑ON" condition, with the largest clinically available treatment field and with a scattering phantom in the useful beam of radiation:

4.1.1.1 Radiation levels in restricted areas are not likely to cause personnel exposures in excess of the limits specified in Part D, Section 6.0 of these regulations; and

4.1.1.2 Radiation levels in unrestricted areas do not exceed the limits specified in Part D, Sections 13.0 and 6.0 of these regulations.

4.1.2.1 After making any change in the treatment room shielding;

4.1.2.2 After making any change in the location of the therapeutic radiation machine within the treatment room;

4.1.2.3 After relocating the therapeutic radiation machine; or

4.1.2.4 Before using the therapeutic radiation machine in a manner that could result in increased radiation levels in areas outside the external beam radiation therapy treatment room.

4.1.3 The survey record shall indicate all instances where the facility, in the opinion of the Qualified Medical Physicist or a qualified expert, is in violation of applicable regulations. The survey record shall also include: the date of the measurements; the reason the survey is required; the manufacturer's name; model number and serial number of the therapeutic radiation machine; the instrument(s) used to measure radiation levels; a plan of the areas surrounding the treatment room that were surveyed; the measured dose rate at several points in each area expressed in microsieverts or millirems per hour; the calculated maximum level of radiation over a period of 1 week for each restricted and unrestricted area; and the signature of the individual responsible for conducting the survey;

4.1.4 If the results of the surveys required by 4.1.1.1 or 4.1.1.2 indicate any radiation levels in excess of the respective limit specified in 4.1.1.1 the registrant shall lock the control in the "OFF" position and not use the unit:

4.1.4.1 Except as may be necessary to repair, replace, or test the therapeutic radiation machine, the therapeutic radiation machine shielding, or the treatment room shielding; or

4.1.4.2 Until the registrant has received a specific exemption from the Agency.

4.2 Modification of Radiation Therapy Unit or Room Before Beginning a Treatment Program. If the survey required by 4.1.1 indicates that an individual in an unrestricted area may be exposed to levels of radiation greater than those permitted by Part D, Section 13.0 of these regulations, before beginning the treatment program the registrant shall:

4.2.1 Either equip the unit with beam direction interlocks or add additional radiation shielding to ensure compliance with Part D, Section 13.0 of this regulation;

4.2.2 Perform the survey required by 4.1 again; and

4.2.3 Include in the report required by 4.4 the results of the initial survey, a description of the modification made to comply with 4.2.1 and the results of the second survey; or

4.2.4 Request and receive a registration amendment under Part D, Section 13.0 of these regulations that authorizes radiation levels in unrestricted areas greater than those permitted by Part D, Section 13.0 of these regulations.

4.3 Dosimetry Equipment

4.3.1 The registrant shall have a calibrated dosimetry system available for use. The system shall have been calibrated by the National Institute for Standards and Technology (NIST) or by an American Association of Physicists in Medicine (AAPM) Accredited Dosimetry Calibration Laboratory (ADCL). The calibration shall have been performed within the previous 24 months and after any servicing that may have affected system calibration. An independent survey shall be conducted by a qualified expert or Qualified Medical Physicist other than the person performing the original survey prior to the equipment being used except as described in Part X, Section 4.0.

4.3.1.1 For beams with energies greater than 1 MV (1 MeV), the dosimetry system shall have been calibrated for Cobalt‑60;

4.3.1.2 For beams with energies equal to or less than 1 MV (1 MeV), the dosimetry system shall have been calibrated at an energy (energy range) appropriate for the radiation being measured;

4.3.2 The registrant shall have available for use a dosimetry system for quality assurance check measurements. To meet this requirement, the system may be compared with a system that has been calibrated in accordance with 4.3.1. This comparison shall have been performed within the previous 12 months and after each servicing that may have affected system calibration. The quality assurance check system may be the same system used to meet the requirement in 4.3.1.

4.4 Reports of External Beam Radiation Therapy Surveys and Measurements. The registrant for any therapeutic radiation machine subject to 6.0 or 7.0 shall furnish a copy of the records required in 4.1 and 4.2 to the Agency within 30 days following completion of the action that initiated the record requirement.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-5.0** Quality Management Program {#sec-4465-5.0 omnilex-key=us-de-regs-official--title-16--4465-5.0}

5.1 Scope and Applicability. Each registrant or applicant subject to 6.0, 7.0 or 11.0 shall develop, implement, and maintain a quality management program to provide high confidence that radiation will be administered as directed by the authorized user. The quality management program shall address, as a minimum, the following specific objectives:

5.1.1 Written Directives

5.1.1.1 A written directive must be dated and signed by an authorized user prior to the administration of radiation.

If because of the patient’s condition, a delay in the order to provide a written revision to an existing written directive would jeopardize the patient’s health, an oral revision to an existing written directive will be acceptable, provided that the oral revision is documented as soon as possible in writing in the patient’s record and a revised written directive is signed by an authorized user within 48 hours of the oral revision.

5.1.1.2 The written directive must contain the patient or human research subject’s name, the type and energy of the beam, the total dose, dose per fraction, treatment site, and number of fractions.

5.1.1.3 A written revision to an existing written directive may be made provided that the revision is dated and signed by an authorized user prior to the administration of the therapeutic radiation machine dose, or the next fractional dose.

5.1.1.4 The registrant shall retain a copy of the written directive for 3 years.

5.1.2 Procedures for Administrations. The registrant shall develop, implement, and maintain written procedures to provide high confidence that:

5.1.2.1 Prior to the administration of each course of radiation treatments, the patient’s or human research subject’s identity is verified by more than 1 method as the individual named in the written directive;

5.1.2.2 Each administration is in accordance with the written directive;

5.1.2.3 Therapeutic radiation machine final plans of treatment and related calculations are in accordance with the respective written directives by:

5.1.2.3.1 Checking both manual and computer generated dose calculations to verify they are correct and in accordance with the written directive; and

5.1.2.3.2 Verifying that any computer-generated calculations are correctly transferred into the consoles of authorized therapeutic medical units;

5.1.2.4 Any unintended deviation from the written directive is identified, evaluated and appropriate action is taken; and

5.1.2.5 The registrant retains a copy of the procedures for administrations for the duration of the registration.

5.2 Reports and Notifications of Misadministrations

5.2.1 A registrant shall report any event resulting from intervention of a patient or human research subject in which the administration of therapeutic radiation machine radiation results, or will result in, unintended permanent functional damage to an organ or a physiological system as determined by a physician.

5.2.2 Other than events that result from intervention by a patient or human research subject, a registrant shall report any event in which the administration of a therapeutic radiation machine therapy dose:

5.2.2.1 Involves the wrong patient, wrong treatment modality, or wrong treatment site; or

5.2.2.2 The calculated weekly administered dose differs from the weekly prescribed dose by more than 30%; or

5.2.2.3 The calculated total administered dose differs from the total prescribed dose by more than 20% of the total prescribed dose;

5.2.4.1 The registrant’s name;

5.2.4.2 The name of the prescribing physician;

5.2.4.3 A brief description of the event;

5.2.4.4 Why the event occurred;

5.2.4.5 The effect, if any, on the individuals(s) who received the administration;

5.2.4.6 Actions, if any, that have been taken, or are planned, to prevent recurrence;

5.2.4.7 Certification that the registrant notified the individual (or the individual’s responsible relative or guardian), and if not, why not.

5.2.5 The report shall not contain the individual’s name or any other information that could lead to the identification of the individual.

5.2.6 The registrant shall provide notification of the event to the referring physician and also notify the individual who is the subject of the misadministration no later than 24 hours after its discovery, unless the referring physician personally informs the registrant either that he or she will inform the individual or that, based on medical judgment, telling the individual would be harmful. The registrant is not required to notify the individual without first consulting the referring physician. If the referring physician or the affected individual cannot be reached within 24 hours, the registrant shall notify the individual as soon as possible thereafter. The registrant may not delay any appropriate medical care for the individual, including any necessary remedial care as a result of the misadministration, because of any delay in notification. To meet the requirements of this paragraph, the notification of the individual who is the subject of the misadministration may be made instead to that individual’s responsible relative or guardian. If a verbal notification is made, the registrant shall inform the individual, or appropriate responsible relative or guardian, that a written description of the event can be obtained from the registrant upon request. The registrant shall provide such a written description if requested.

5.2.7 Aside from the notification requirement, nothing in this section affects any rights or duties of registrants and physicians in relation to each other, to individuals affected by the misadministration, or to that individual’s responsible relatives or guardians.

5.2.8 The registrant shall retain a record of a misadministration in accordance with 5.3. A copy of the record required shall be provided to the referring physician if other than the registrant within 15 days after discovery of the misadministration.

5.3 Records of Misadministrations. A registrant shall retain a record of misadministrations reported in accordance with 5.2 for 3 years. The record must contain the following:

5.3.1 The registrant’s name and the names of the individuals involved;

5.3.2 The social security number or other identification number, if one has been assigned, of the individual who is the subject of the misadministration;

5.3.3 A brief description of the event; why it occurred; the effect, if any, on the individual;

5.3.4 The actions, if any, taken or planned to prevent recurrence; and

5.3.5 Whether the registrant notified the individual (or the individual’s responsible relative or guardian) and, if not, whether such failure to notify was based on guidance from the referring physician.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-6.0** Therapeutic Radiation Machines of Less Than 500 kV. 4/ {#sec-4465-6.0 omnilex-key=us-de-regs-official--title-16--4465-6.0}

6.1 Leakage Radiation. When the X‑ray tube is operated at its maximum rated tube current for the maximum kV, the leakage air kerma rate shall not exceed the value specified at the distance specified for that classification of therapeutic radiation machine:

6.1.1 5‑50 kV Systems. The leakage air kerma rate measured at any position 5 centimeters from the tube housing assembly shall not exceed 1 mGy (100 mrad) in any 1 hour.

6.1.2 >50 and <500 kV Systems. The leakage air kerma rate measured at a distance of 1 meter from the target in any direction shall not exceed 1 cGy (1 rad) in any 1 hour. This air kerma rate measurement may be averaged over areas no larger than one hundred square centimeters (100 cm2). In addition, the air kerma rate at a distance of 5 centimeters from the surface of the tube housing assembly shall not exceed 30 cGy (30 rad) per hour.

6.1.3 For each therapeutic radiation machine, the registrant shall determine, or obtain from the manufacturer, the leakage radiation existing at the positions specified in 6.1.1 and 6.1.2 for the specified operating conditions. Records on leakage radiation measurements shall be maintained at the installation for inspection by the Agency.

6.2 Permanent Beam Limiting Devices. Permanent diaphragms or cones used for limiting the useful beam shall provide at least the same degree of attenuation as required for the tube housing assembly.

6.3 Adjustable or Removable Beam Limiting Devices

6.3.1 All adjustable or removable beam limiting devices, diaphragms, cones or blocks shall not transmit more than 5% of the useful beam for the most penetrating beam used;

6.3.2 When adjustable beam limiting devices are used, the position and shape of the radiation field shall be indicated by a light beam.

6.4 Filter System. The filter system shall be so designed that:

6.4.1 Filters can not be accidentally displaced at any possible tube orientation;

6.4.2 For equipment installed after July 10, 2002 an interlock system prevents irradiation if the proper filter is not in place;

6.4.3 The air kerma rate escaping from the filter slot shall not exceed 1 cGy (1 rad) per hour at 1 meter under any operating conditions; and

6.4.4 Each filter shall be marked as to its material of construction and its thickness.

6.5 Tube Housing

6.5.1 The X‑ray tube shall be so mounted that it can not accidentally turn or slide with respect to the housing aperture; and

6.5.2 The tube housing assembly shall be capable of being immobilized for stationary portal treatments.

6.5.3 Source Marking. The tube housing assembly shall be so marked that it is possible to determine the location of the source to within 5 millimeters, and such marking shall be readily accessible for use during calibration procedures.

6.6 Beam Block. Contact therapy tube housing assemblies shall have a removable shield of material, equivalent in attenuation to 0.5 millimeters of lead at 100 kV, which can be positioned over the entire useful beam exit port during periods when the beam is not in use.

6.7 Timer. A suitable irradiation control device shall be provided to terminate the irradiation after a pre‑set time interval.

6.7.1 A timer with a display shall be provided at the treatment control panel. The timer shall have a pre‑set time selector and an elapsed time or time remaining indicator;

6.7.2 The timer shall be a cumulative timer that activates with an indication of "BEAM‑ON" and retains its reading after irradiation is interrupted or terminated. After irradiation is terminated and before irradiation can be reinitiated, it shall be necessary to reset the elapsed time indicator;

6.7.3 The timer shall terminate irradiation when a pre‑selected time has elapsed, if any dose monitoring system present has not previously terminated irradiation;

6.7.4 The timer shall permit accurate pre‑setting and determination of exposure times as short as 1 second;

6.7.5 The timer shall not permit an exposure if set at 0;

6.7.6 The timer shall not activate until the shutter is opened when irradiation is controlled by a shutter mechanism unless calibration includes a timer error correction to compensate for mechanical lag; and

6.7.7 Timer shall be accurate to within 1% of the selected value or 1 second, whichever is greater.

6.8 Control Panel Functions. The control panel, in addition to the displays required by other provisions in 6.0 shall have:

6.8.1 An indication of whether electrical power is available at the control panel and if activation of the X‑ray tube is possible;

6.8.2 An indication of whether X‑rays are being produced;

6.8.3 A means for indicating X‑ray tube potential and current;

6.8.4 The means for terminating an exposure at any time;

6.8.5 A locking device which will prevent unauthorized use of the therapeutic radiation machine; and

6.8.6 For therapeutic radiation machines manufactured after July 10, 2002, a positive display of specific filter(s) in the beam.

6.9 Multiple Tubes. When a control panel may energize more than 1 X‑ray tube:

6.9.1 It shall be possible to activate only 1 X‑ray tube at any time;

6.9.2 There shall be an indication at the control panel identifying which X‑ray tube is activated; and

6.9.3 There shall be an indication at the tube housing assembly when that tube is energized.

6.10 Target‑to‑Skin Distance (TSD). There shall be a means of determining the central axis TSD to within 1 centimeter and of reproducing this measurement to within 2 millimeters thereafter.

6.11 Shutters. Unless it is possible to bring the X‑ray output to the prescribed exposure parameters within 5 seconds after the X‑ray "ON" switch is energized, the beam shall be attenuated by a shutter having a lead equivalency not less than that of the tube housing assembly. In addition, after the unit is at operating parameters, the shutter shall be controlled by the operator from the control panel. An indication of shutter position shall appear at the control panel.

6.12 Low Filtration X‑ray Tubes. Each therapeutic radiation machine equipped with a beryllium or other low‑filtration window shall be clearly labeled as such upon the tube housing assembly and shall be provided with a permanent warning device on the control panel that is activated when no additional filtration is present, to indicate that the dose rate is very high.

6.13 Facility Design Requirements for Therapeutic Radiation Machines Capable of Operating in the Range 50 kV to 500 kV. In addition to shielding adequate to meet requirements of 9.0, the treatment room shall meet the following design requirements:

6.13.1 Aural Communication. Provision shall be made for continuous 2‑way aural communication between the patient and the operator at the control panel;

6.13.2 Viewing Systems. Provision shall be made to permit continuous observation of the patient during irradiation and the viewing system shall be so located that the operator can observe the patient from the control panel. The therapeutic radiation machine shall not be used for patient irradiation unless at least 1 viewing system is operational.

6.14 Additional Requirements. Treatment rooms that contain a therapeutic radiation machine capable of operating above 150 kV shall meet the following additional requirements:

6.14.1 All protective barriers shall be fixed except for entrance doors or beam interceptors;

6.14.2 The control panel shall be located outside the treatment room or in a totally enclosed booth, which has a ceiling, inside the room;

6.14.3 Interlocks shall be provided such that all entrance doors, including doors to any interior booths, shall be closed before treatment can be initiated or continued. If the radiation beam is interrupted by any door opening, it shall not be possible to restore the machine to operation without closing the door and reinitiating irradiation by manual action at the control panel; and

6.14.4 When any door referred to in 6.14.3 is opened while the X‑ray tube is activated, the air kerma rate at a distance of 1 meter from the source shall be reduced to less than 1 mGy (100 mrad) per hour.

6.15 Full Calibration Measurements

6.15.1 Full calibration of a therapeutic radiation machine subject to 6.0 shall be performed by, or under the direct supervision of, a Qualified Medical Physicist:

6.15.1.1 Before the first medical use following installation or reinstallation of the therapeutic radiation machine;

6.15.1.2 At intervals not exceeding 1 year; and

6.15.1.3 Before medical use under the following conditions:

6.15.1.3.1 Whenever quality assurance check measurements indicate that the radiation output differs by more than 5% from the value obtained at the last full calibration and the difference cannot be reconciled; and

6.15.1.3.2 Following any component replacement, major repair, or modification of components that could significantly affect the characteristics of the radiation beam.

6.15.1.4 Notwithstanding the requirements of 6.15.1.3:

6.15.1.4.1 Full calibration of therapeutic radiation machines with multi‑energy capabilities is required only for those modes and/or energies that are not within their acceptable range; and

6.15.1.4.2 If the repair, replacement or modification does not affect all energies, full calibration shall be performed on the affected energy that is in most frequent clinical use at the facility. The remaining energies may be validated with quality assurance check procedures against the criteria in 6.15.1.4.1

6.15.2 To satisfy the requirement of 6.15.1 full calibration shall include all measurements recommended for annual calibration by NCRP Report 69, "Dosimetry of X‑Ray and Gamma Ray Beams for Radiation Therapy in the Energy Range 10 keV to 50 MeV" (1981).

6.16 Periodic Quality Assurance Checks

6.16.1 Periodic quality assurance checks shall be performed on therapeutic radiation machines subject to 6.0 which are capable of operation at greater than or equal to 50 kV.

6.16.2 To satisfy the requirement of 6.16.1 quality assurance checks shall meet the following requirements:

6.16.2.1 The registrant shall perform quality assurance checks in accordance with written procedures established by the Qualified Medical Physicist; and

6.16.2.2 The quality assurance check procedures shall specify the frequency at which tests or measurements are to be performed. The quality assurance check procedures shall specify that the quality assurance check shall be performed during the calibration specified in 6.15.1. The acceptable tolerance for each parameter measured in the quality assurance check, when compared to the value for that parameter determined in the calibration specified in 6.15.1 shall be stated.

6.16.3 The cause for a parameter exceeding a tolerance set by the Qualified Medical Physicist shall be investigated and corrected before the system is used for patient irradiation;

6.16.4 Whenever a quality assurance check indicates a significant change in the operating characteristics of a system, as specified in the Qualified Medical Physicist's quality assurance check procedures, the system shall be recalibrated as required in 6.15.1;

6.16.5 The registrant shall use the dosimetry system described in 4.3.2 to make the quality assurance check required in 6.15.2;

6.16.6 The registrant shall have the Qualified Medical Physicist review and sign the results of each radiation output quality assurance check within 30 days of the date that the check was performed;

6.16.7 The registrant shall ensure that safety quality assurance checks of therapeutic radiation machines subject to 6.0 are performed at intervals not to exceed 30 days;

6.16.8 Notwithstanding the requirements of 6.16.6 and 6.16.7, the registrant shall ensure that no therapeutic radiation machine is used to administer radiation to humans unless the quality assurance checks required by 6.16.6 and 6.16.7 have been performed within the 30 day period immediately prior to said administration;

6.16.9 To satisfy the requirement of 6.16.7 safety quality assurance checks shall ensure proper operation of:

6.16.9.1 Electrical interlocks at each external beam radiation therapy room entrance;

6.16.9.2 The "BEAM‑ON" and termination switches;

6.16.9.3 Beam condition indicator lights on the access door(s), control console, and in the radiation therapy room;

6.16.9.4 Viewing systems;

6.16.9.5 If applicable, electrically operated treatment room doors from inside and outside the treatment room;

6.16.10 The registrant shall maintain a record of each quality assurance check required by 6.16.1 and 6.16.7 for 3 years. The record shall include: the date of the quality assurance check; the manufacturer's name, model number, and serial number of the therapeutic radiation machine; the manufacturer's name; model number and serial number for the instrument(s) used to measure the radiation output of the therapeutic radiation machine; and the signature of the individual who performed the periodic quality assurance check.

6.17 Operating Procedures

6.17.1 The therapeutic radiation machine shall not be used for irradiation of patients unless the requirements of 6.15 and 6.16 have been met;

6.17.2 Therapeutic radiation machines shall not be left unattended unless secured pursuant to 6.7.5;

6.17.3 When a patient must be held in position for radiation therapy, mechanical supporting or restraining devices shall be used;

6.17.4 The tube housing assembly shall not be held by an individual during operation unless the assembly is designed to require such holding and the peak tube potential of the system does not exceed 50 kV. In such cases, the holder shall wear protective gloves and apron of not less than 0.5 millimeters lead equivalency at 100 kV;

6.17.5 A copy of the current operating and emergency procedures shall be maintained at the therapeutic radiation machine control console; and

6.17.6 No individual other than the patient shall be in the treatment room during exposures from therapeutic radiation machines operating above 150 kV. At energies less than or equal to 150 kV, any individual, other than the patient, in the treatment room shall be protected by a barrier sufficient to meet the requirements of Part D, Section 6.0 of these regulations.

6.18 Possession of Survey Instrument(s). Each facility location authorized to use a therapeutic radiation machine in accordance with 6.0 shall possess appropriately calibrated portable monitoring equipment. As a minimum, such equipment shall include a portable radiation measurement survey instrument capable of measuring dose rates over the range 10 μSv (1 mrem) per hour to 10 mSv (1000 mrem) per hour. The survey instrument(s) shall be operable and calibrated in accordance with 8.0.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-7.0** Therapeutic Radiation Machines ‑ Photon Therapy Systems (500 kV and Above) and Electron Therapy Systems (500 keV and Above) {#sec-4465-7.0 omnilex-key=us-de-regs-official--title-16--4465-7.0}

7.1 Possession of Survey Instrument(s). Each facility location authorized to use a therapeutic radiation machine in accordance with 7.0 shall possess appropriately calibrated portable monitoring equipment. As a minimum, such equipment shall include a portable radiation measurement survey instrument capable of measuring dose rates over the range 10 µSv (1 mrem) per hour to 10 mSv (1000 mrem) per hour. The survey instrument(s) shall be operable and calibrated in accordance with 8.0.

7.2 Leakage Radiation Outside the Maximum Useful Beam in Photon and Electron Modes

7.2.1 The absorbed dose due to leakage radiation (excluding neutrons) at any point outside the maximum sized useful beam, but within a circular plane of radius 2 meters which is perpendicular to and centered on the central axis of the useful beam at the nominal treatment distance (i.e. patient plane), shall not exceed a maximum of 0.2% and an average of 0.1% of the absorbed dose on the central axis of the beam at the nominal treatment distance. Measurements shall be averaged over an area not exceeding 100 square centimeters at a minimum of 16 points uniformly distributed in the plane;

7.2.2 Except for the area defined in 7.2.1 the absorbed dose due to leakage radiation (excluding neutrons) at 1 meter from the electron path between the electron source and the target or electron window shall not exceed 0.5% of the absorbed dose on the central axis of the beam at the nominal treatment distance. Measurements shall be averaged over an area not exceeding 100 square centimeters;

7.2.3 For equipment manufactured after July 10, 2002 the neutron absorbed dose outside the useful beam shall be in compliance with International Electrotechnical Commission (IEC) Document 60601‑2‑1 (most current revision); and

7.2.4 For each therapeutic radiation machine, the registrant shall determine, or obtain from the manufacturer, the leakage radiation existing at the positions specified in 7.2.1 through 7.2.3 for the specified operating conditions. Records on leakage radiation measurements shall be maintained at the installation for inspection by the Agency.

7.3 Leakage Radiation Through Beam Limiting Devices

7.3.1 Photon Radiation. All adjustable or interchangeable beam limiting devices shall attenuate the useful beam such that at the nominal treatment distance, the maximum absorbed dose anywhere in the area shielded by the beam limiting device(s) shall not exceed 2% of the maximum absorbed dose on the central axis of the useful beam measured in a 100 square centimeters radiation field, or maximum available field size if less than 100 square centimeters;

7.3.2 Electron Radiation. All adjustable or interchangeable electron applicators shall attenuate the radiation, including but not limited to photon radiation generated by electrons incident on the beam limiting device and electron applicator and other parts of the radiation head, such that the absorbed dose in a plane perpendicular to the central axis of the useful beam at the nominal treatment distance shall not exceed:

7.3.2.1 A maximum of 2% and average of 0.5% of the absorbed dose on the central axis of the useful beam at the nominal treatment distance. This limit shall apply beyond a line 7 centimeters outside the periphery of the useful beam; and

7.3.2.2 A maximum of 10% of the absorbed dose on the central axis of the useful beam at the nominal treatment distance. This limit shall apply beyond a line 2 centimeters outside the periphery of the useful beam.

7.3.2.3 Measurement of Leakage Radiation

7.3.2.3.1 Photon Radiation. Measurements of leakage radiation through the beam limiting devices shall be made with the beam limiting devices closed and any residual aperture blocked by at least 2 tenth value layers of suitable absorbing material. In the case of overlapping beam limiting devices, the leakage radiation through each set shall be measured independently at the depth of maximum dose. Measurements shall be made using a radiation detector of area not exceeding 10 square centimeters;

7.3.2.3.2 Electron Radiation. Measurements of leakage radiation through the electron applicators shall be made with the electron beam directed into the air and using a radiation detector of area up to but not exceeding 1 square centimeter suitably protected against radiation which has been scattered from material beyond the radiation detector. Measurements shall be made using 1 centimeter of water equivalent build up material.

7.4 Filters/Wedges

7.4.1 Each wedge filter that is removable from the system shall be clearly marked with an identification number. For removable wedge filters, the nominal wedge angle shall appear on the wedge or wedge tray (if permanently mounted to the tray). If the wedge or wedge tray is significantly damaged, the wedge transmission factor shall be redetermined;

7.4.2 If the absorbed dose rate information required by 7.9 relates exclusively to operation with a field flattening filter or beam scattering foil in place, such foil or filter shall be removable only by the use of tools;

7.4.3 For equipment manufactured after July 10, 2002 which utilizes wedge filters, interchangeable field flattening filters, or interchangeable beam scattering foils:

7.4.3.1 Irradiation shall not be possible until a selection of a filter or a positive selection to use "no filter" has been made at the treatment control panel, either manually or automatically;

7.4.3.2 An interlock system shall be provided to prevent irradiation if the filter selected is not in the correct position;

7.4.3.3 A display shall be provided at the treatment control panel showing the wedge filter(s), interchangeable field flattening filter(s), and/or interchangeable beam scattering foil(s) in use; and

7.4.3.4 An interlock shall be provided to prevent irradiation if any filter and/or beam scattering foil selection operation carried out in the treatment room does not agree with the filter and/or beam scattering foil selection operation carried out at the treatment control panel.

7.5 Stray Radiation in the Useful Beam. For equipment manufactured after July 10, 2002, the registrant shall determine during acceptance testing, or obtain from the manufacturer, data sufficient to ensure that X‑ray stray radiation in the useful electron beam, absorbed dose at the surface during X‑ray irradiation and stray neutron radiation in the useful X‑ray beam are in compliance with International Electrotechnical Commission (IEC) Document 60601‑2‑1 (most current revision).

7.6 Beam Monitors. All therapeutic radiation machines subject to 7.0 shall be provided with redundant beam monitoring systems. The sensors for these systems shall be fixed in the useful beam during treatment to indicate the dose monitor unit rate.

7.6.1 Equipment manufactured after July 10, 2002 shall be provided with at least 2 independently powered integrating dose meters. Alternatively, common elements may be used if the production of radiation is terminated upon failure of any common element.

7.6.2 Equipment manufactured on or before July 10, 2002 shall be provided with at least 1 radiation detector. This detector shall be incorporated into a useful beam monitoring system;

7.6.3 The detector and the system into which that detector is incorporated shall meet the following requirements:

7.6.3.1 Each detector shall be removable only with tools and, if movable, shall be interlocked to prevent incorrect positioning;

7.6.3.2 Each detector shall form part of a beam monitoring system from whose readings in dose monitor units the absorbed dose at a reference point can be calculated;

7.6.3.3 Each beam monitoring system shall be capable of independently monitoring, interrupting, and terminating irradiation; and

7.6.3.4 For equipment manufactured after July 10, 2002, the design of the beam monitoring systems shall ensure that the:

7.6.3.4.1 Malfunctioning of 1 system shall not affect the correct functioning of the other system(s); and

7.6.3.4.2 Failure of either system shall terminate irradiation or prevent the initiation of radiation.

7.6.3.5 Each beam monitoring system shall have a legible display at the treatment control panel. For equipment manufactured after July 10, 2002, each display shall:

7.6.3.5.1 Maintain a reading until intentionally reset;

7.6.3.5.2 Have only 1 scale and no electrical or mechanical scale multiplying factors;

7.6.3.5.3 Utilize a design such that increasing dose is displayed by increasing numbers; and

7.6.3.5.4 In the event of power failure, the beam monitoring information required in 7.6.3.5.3 displayed at the control panel at the time of failure shall be retrievable

7.7 Beam Symmetry

7.7.1 A bent‑beam linear accelerator with beam flattening filter(s) subject to 7.0 shall be provided with auxiliary device(s) to monitor beam symmetry;

7.7.2 The device(s) referenced in 7.7.1 shall be able to detect field asymmetry greater than 10%; and

7.7.3 The device(s) referenced in 7.7.1 shall be configured to terminate irradiation if the specifications in 7.7.2 can not be maintained.

7.8 Selection and Display of Dose Monitor Units

7.8.1 Irradiation shall not be possible until a new selection of a number of dose monitor units has been made at the treatment control panel;

7.8.2 The pre‑selected number of dose monitor units shall be displayed at the treatment control panel until reset manually for the next irradiation;

7.8.3 After termination of irradiation, it shall be necessary to reset the dosimeter display before subsequent treatment can be initiated; and

7.8.4 For equipment manufactured after July 10, 2002, after termination of irradiation, it shall be necessary for the operator to reset the pre‑selected dose monitor units before irradiation can be initiated.

7.9 Air Kerma Rate/Absorbed Dose Rate. For equipment manufactured after July 10, 2002, a system shall be provided from whose readings the air kerma rate or absorbed dose rate at a reference point can be calculated. [The radiation detectors specified in 7.6 may form part of this system.] In addition:

7.9.1 The dose monitor unit rate shall be displayed at the treatment control panel;

7.9.2 If the equipment can deliver under any conditions an air kerma rate or absorbed dose rate at the nominal treatment distance more than twice the maximum value specified by the manufacturer, a device shall be provided which terminates irradiation when the air kerma rate or absorbed dose rate exceeds a value twice the specified maximum. The dose rate at which the irradiation will be terminated shall be a record maintained by the registrant;

7.9.3 If the equipment can deliver under any fault condition(s) an air kerma rate or absorbed dose rate at the nominal treatment distance more than 10 times the maximum value specified by the manufacturer, a device shall be provided to prevent the air kerma rate or absorbed dose rate anywhere in the radiation field from exceeding twice the specified maximum value and to terminate irradiation if the excess absorbed dose at the nominal treatment distance exceeds 4 Gy (400 rad); and

7.9.4 For each therapeutic radiation machine, the registrant shall determine, or obtain from the manufacturer, the maximum value(s) specified in 7.9.2 and 7.9.3 for the specified operating conditions. Records of these maximum value(s) shall be maintained at the installation for inspection by the Agency.

7.10 Termination of Irradiation by the Beam Monitoring System or Systems During Stationary Beam Radiation Therapy

7.10.1 Each primary system shall terminate irradiation when the pre‑selected number of dose monitor units has been detected by the system;

7.10.2 If the original design of the equipment included a secondary dose monitoring system, that system shall be capable of terminating irradiation when not more than 15% or 40 dose monitor units above the pre‑selected number of dose monitor units set at the control panel has been detected by the secondary dose monitoring system; and

7.10.3 For equipment manufactured after July 10, 2002, an indicator on the control panel shall show which monitoring system has terminated irradiation.

7.11 Termination of Irradiation. It shall be possible to terminate irradiation and equipment movement or go from an interruption condition to termination condition at any time from the operator's position at the treatment control panel.

7.12 Interruption of Irradiation. If a therapeutic radiation machine has an interrupt mode, it shall be possible to interrupt irradiation and equipment movements at any time from the treatment control panel. Following an interruption it shall be possible to restart irradiation by operator action without any reselection of operating conditions. If any change is made of a pre‑selected value during an interruption, irradiation and equipment movements shall be automatically terminated.

7.13 Timer. A suitable irradiation control device shall be provided to terminate the irradiation after a pre‑set time interval.

7.13.1 A timer shall be provided which has a display at the treatment control panel. The timer shall have a pre‑set time selector and an elapsed time indicator;

7.13.2 The timer shall be a cumulative timer that activates with an indication of "BEAM‑ON" and retains its reading after irradiation is interrupted or terminated. After irradiation is terminated and before irradiation can be reinitiated, it shall be necessary to reset the elapsed time indicator;

7.13.3 The timer shall terminate irradiation when a pre‑selected time has elapsed, if the dose monitoring systems have not previously terminated irradiation.

7.14 Selection of Radiation Type. Equipment capable of both X‑ray therapy and electron therapy shall meet the following additional requirements:

7.14.1 Irradiation shall not be possible until a selection of radiation type (X‑rays or electrons) has been made at the treatment control panel;

7.14.2 The radiation type selected shall be displayed at the treatment control panel before and during irradiation;

7.14.3 An interlock system shall be provided to ensure that the equipment can principally emit only the radiation type that has been selected;

7.14.4 An interlock system shall be provided to prevent irradiation with X‑rays, except to obtain an image, when electron applicators are fitted;

7.14.5 An interlock system shall be provided to prevent irradiation with electrons when accessories specific for X‑ray therapy are fitted; and

7.14.6 An interlock system shall be provided to prevent irradiation if any selected operations carried out in the treatment room do not agree with the selected operations carried out at the treatment control panel.

7.15 Selection of Energy. Equipment capable of generating radiation beams of different energies shall meet the following requirements:

7.15.1 Irradiation shall not be possible until a selection of energy has been made at the treatment control panel;

7.15.2 The nominal energy value selected shall be displayed at the treatment control panel until reset manually for the next irradiation. After termination of irradiation, it shall be necessary to reset the nominal energy value selected before subsequent treatment can be initiated;

7.15.3 Irradiation shall not be possible until the appropriate flattening filter or scattering foil for the selected energy is in its proper location; and

7.15.4 For equipment manufactured after July 10, 2002, the selection of energy shall be in compliance with International Electrotechnical Commission (IEC) Document 60601‑2‑1 (most current revision).

7.16 Selection of Stationary Beam Radiation Therapy or Moving Beam Radiation Therapy. Therapeutic radiation machines capable of both stationary beam radiation therapy and moving beam radiation therapy shall meet the following requirements:

7.16.1 Irradiation shall not be possible until a selection of stationary beam radiation therapy or moving beam radiation therapy has been made at the treatment control panel;

7.16.2 The mode of operation shall be displayed at the treatment control panel;

7.16.3 An interlock system shall be provided to ensure that the equipment can operate only in the mode that has been selected;

7.16.4 An interlock system shall be provided to prevent irradiation if any selected parameter in the treatment room does not agree with the selected parameter at the treatment control panel;

7.16.5 Moving beam radiation therapy shall be controlled to obtain the selected relationships between incremental dose monitor units and incremental movement. For equipment manufactured after July 10, 2002:

7.16.5.1 An interlock system shall be provided to terminate irradiation if the number of dose monitor units delivered in any 10 degrees of rotation or 1 centimeter of linear motion differs by more than 20% from the selected value;

7.16.5.2 Where angle terminates the irradiation in moving beam radiation therapy, the dose monitor units delivered shall differ by less than 5% from the dose monitor unit value selected;

7.16.5.3 An interlock shall be provided to prevent motion of more than 5 degrees or 1 centimeter beyond the selected limits during moving beam radiation therapy;

7.16.5.4 An interlock shall be provided to require that a selection of direction be made at the treatment control panel in all units which are capable of both clockwise and counter‑clockwise moving beam radiation therapy.

7.16.5.5 Moving beam radiation therapy shall be controlled with both primary position sensors and secondary position sensors to obtain the selected relationships between incremental dose monitor units and incremental movement.

7.16.6 Where the beam monitor system terminates the irradiation in moving beam radiation therapy, the termination of irradiation shall be as required by 7.10; and

7.16.7 For equipment manufactured after July 10, 2002, an interlock system shall be provided to terminate irradiation if movement:

7.16.7.1 Occurs during stationary beam radiation therapy; or

7.16.7.2 Does not start or stops during moving beam radiation therapy unless such stoppage is a pre‑planned function.

7.17 Facility Design Requirements for Therapeutic Radiation Machines Operating above 500 kV. In addition to shielding adequate to meet requirements of 9.0 the following design requirements are made:

7.17.1 Protective Barriers. All protective barriers shall be fixed, except for access doors to the treatment room or movable beam interceptors;

7.17.2 Control Panel. In addition to other requirements specified in Part X, the control panel shall also:

7.17.2.1 Be located outside the treatment room;

7.17.2.2 Provide an indication of whether electrical power is available at the control panel and if activation of the radiation is possible;

7.17.2.3 Provide an indication of whether radiation is being produced; and

7.17.2.4 Include an access control (locking) device that will prevent unauthorized use of the therapeutic radiation machine;

7.17.3 Viewing Systems. Windows, mirrors, closed‑circuit television or an equivalent viewing system shall be provided to permit continuous observation of the patient following positioning and during irradiation and shall be so located that the operator may observe the patient from the treatment control panel. The therapeutic radiation machine shall not be used for patient irradiation unless at least one viewing system is operational;

7.17.4 Aural Communications. Provision shall be made for continuous 2‑way aural communication between the patient and the operator at the control panel. The therapeutic radiation machine shall not be used for irradiation of patients unless continuous 2‑way aural communication is possible;

7.17.5 Room Entrances. Treatment room entrances shall be provided with warning lights in a readily observable position near the outside of all access doors, which will indicate when the useful beam is "ON" and when it is "OFF";

7.17.6 Entrance Interlocks. Interlocks shall be provided such that all access controls are activated before treatment can be initiated or continued. If the radiation beam is interrupted by any access control, it shall not be possible to restore the machine to operation without resetting the access control and reinitiating irradiation by manual action at the control panel;

7.17.7 Beam Interceptor Interlocks. If the shielding material in any protective barrier requires the presence of a beam interceptor to ensure compliance with Part D, Section 13.0 of these regulations, interlocks shall be provided to prevent the production of radiation, unless the beam interceptor is in place, whenever the useful beam is directed at the designated barrier(s);

7.17.8 Emergency Cutoff Switches. At least 1 emergency power cutoff switch shall be located in the radiation therapy room and shall terminate all equipment electrical power including radiation and mechanical motion. This switch is in addition to the termination switch required by 7.11. All emergency power cutoff switches shall include a manual reset so that the therapeutic radiation machine cannot be restarted from the unit's control console without resetting the emergency cutoff switch;

7.17.9 Safety Interlocks. All safety interlocks shall be designed so that any defect or component failure in the safety interlock system prevents or terminates operation of the therapeutic radiation machine; and

7.17.10 Surveys for Residual Radiation. Surveys for residual activity shall be conducted on all therapeutic radiation machines capable of generating photon and electron energies above 10 MV prior to machining, removing, or working on therapeutic radiation machine components which may have become activated due to photo‑neutron production.

7.18 Qualified Medical Physicist Support

7.18.1 The services of a Qualified Medical Physicist shall be required in facilities having therapeutic radiation machines with energies of 500 kV and above. The Qualified Medical Physicist shall be responsible for:

7.18.1.1 Full calibration(s) required by 7.20 and protection surveys required by 4.1;

7.18.1.2 Supervision and review of dosimetry;

7.18.1.3 Beam data acquisition and transfer for computerized dosimetry, and supervision of its use;

7.18.1.4 Quality assurance, including quality assurance check review required by 7.21.4;

7.18.1.5 Consultation with the authorized user in treatment planning, as needed; and

7.18.1.6 Perform calculations/assessments regarding misadministrations.

7.18.2 If the Qualified Medical Physicist is not a full‑time employee of the registrant, the operating procedures required by 7.19 shall also specifically address how the Qualified Medical Physicist is to be contacted for problems or emergencies, as well as the specific actions, if any, to be taken until the Qualified Medical Physicist can be contacted.

7.19 Operating Procedures

7.19.1 No individual, other than the patient, shall be in the treatment room during treatment or during any irradiation for testing or calibration purposes;

7.19.2 Therapeutic radiation machines shall not be made available for medical use unless the requirements of 4.1, 7.20 and 7.21 have been met;

7.19.3 Therapeutic radiation machines, when not in operation, shall be secured to prevent unauthorized use;

7.19.4 When adjustable beam limiting devices are used, the position and shape of the radiation field shall be indicated by a light field.

7.19.5 If a patient must be held in position during treatment, mechanical supporting or restraining devices shall be used; and

7.19.6 A copy of the current operating and emergency procedures shall be maintained at the therapeutic radiation machine control console.

7.20 Acceptance Testing, Commissioning and Full Calibration Measurements

7.20.1 Acceptance testing, commissioning and full calibration of a therapeutic radiation machine subject to 7.0 shall be performed by, or under the direct supervision of, a Qualified Medical Physicist.

7.20.2 Acceptance testing and commissioning shall be performed in accordance with "AAPM Code of Practice for Radiotherapy Accelerators: AAPM Report No. 47", prepared by Radiation Therapy Task Group 45 and the manufacturer’s contractual specifications. Acceptance testing and commissioning shall be conducted before the first medical use following installation or reinstallation of the therapeutic radiation machine.

7.20.3 Full calibration shall include measurement of all applicable parameters required by Table II of "Comprehensive QA for Radiation Oncology: Report of AAPM Radiation Therapy: AAPM Report No. 46," prepared by Committee Task Group 40 and shall be performed in accordance with "AAPM Code of Practice for Radiotherapy Accelerators: AAPM Report No. 47" prepared by Radiation Therapy Task Group 45. Although it shall not be necessary to complete all elements of a full calibration at the same time, all applicable parameters (for all energies) shall be completed at intervals not exceeding 12 calendar months, unless a more frequent interval is required in Table II.

7.20.4 The Qualified Medical Physicist shall perform all elements of a full calibration necessary to determine that all parameters are within acceptable limits:

7.20.4.1 Whenever quality assurance check measurements indicate that the radiation output differs by more than 5% from the value obtained at the last full calibration and the difference cannot be reconciled. Therapeutic radiation machines with multi‑energy and/or multi‑mode capabilities shall only require measurements for those modes and/or energies that are not within their acceptable range; and

7.20.4.2 Following any component replacement, major repair, or modification of components that could significantly affect the characteristics of the radiation beam. If the repair, replacement or modification does not affect all modes and/or energies, measurements shall be performed on the effected mode/energy that is in most frequent clinical use at the facility. The remaining energies/modes may be validated with quality assurance check procedures against the criteria in 7.20.4.1.

7.20.5 The registrant shall maintain a record of each calibration in an auditable form for the duration of the registration. The record shall include: the date of the calibration; the manufacturer's name, model number and serial number for the therapeutic radiation machine; the model numbers and serial numbers of the instruments used to calibrate the therapeutic radiation machine; and the signature of the Qualified Medical Physicist responsible for performing the calibration.

7.21 Periodic Quality Assurance Checks

7.21.1 Periodic quality assurance checks shall be performed on all therapeutic radiation machines subject to 7.0 at intervals not to exceed those specified in "Comprehensive QA for Radiation Oncology: AAPM Report No. 46,” prepared by AAPM Radiation Therapy Committee Task Group 40;

7.21.2 To satisfy the requirement of 7.21.1, quality assurance checks shall include determination of central axis radiation output and a representative sampling of periodic quality assurance checks contained in "Comprehensive QA for Radiation Oncology: AAPM Report No. 46 prepared by Radiation Therapy Committee Task Group 40. Representative sampling shall include all applicable referenced periodic quality assurance checks in an interval not to exceed 12 consecutive calendar months;

7.21.3 The registrant shall use a dosimetry system that has been intercompared within the previous 12 months with the dosimetry system described in 4.3.1 to make the periodic quality assurance checks required in 7.21.2;

7.21.4 The registrant shall perform periodic quality assurance checks required by 7.21.1 in accordance with procedures established by the Qualified Medical Physicist;

7.21.5 The registrant shall review the results of each periodic radiation output check according to the following procedures:

7.21.5.1 The authorized user and Qualified Medical Physicist shall be immediately notified if any parameter is not within its acceptable tolerance. The therapeutic radiation machine shall not be made available for subsequent medical use until the Qualified Medical Physicist has determined that all parameters are within their acceptable tolerances;

7.21.5.2 If all quality assurance check parameters appear to be within their acceptable range, the quality assurance check shall be reviewed and signed by either the authorized user or Qualified Medical Physicist within 3 treatment days; and

7.21.5.3 The Qualified Medical Physicist shall review and sign the results of each radiation output quality assurance check at intervals not to exceed 30 days.

7.21.6 Therapeutic radiation machines subject to 7.0 shall have applicable safety quality assurance checks listed in "Comprehensive QA for Radiation Oncology: AAPM Report No. 46," prepared by AAPM Radiation Therapy Committee Task Group 40 performed at intervals not to exceed 1 week;

7.21.7 To satisfy the requirement of 7.21.6 safety quality assurance checks shall ensure proper operation of:

7.21.7.1 Electrical interlocks at each external beam radiation therapy room entrance;

7.21.7.2 Proper operation of the "BEAM‑ON", interrupt and termination switches;

7.21.7.3 Beam condition indicator lights on the access doors, control console, and in the radiation therapy room;

7.21.7.4 Viewing systems;

7.21.7.5 Electrically operated treatment room door(s) from inside and outside the treatment room;

7.21.7.6 At least 1 emergency power cutoff switch. If more than 1 emergency power cutoff switch is installed and not all switches are tested at once, each switch shall be tested on a rotating basis. Safety quality assurance checks of the emergency power cutoff switches may be conducted at the end of the treatment day in order to minimize possible stability problems with the therapeutic radiation machine.

7.21.7.7 The registrant shall promptly repair any system identified in 7.21.7 that is not operating properly; and

7.21.8 The registrant shall maintain a record of each quality assurance check required by 7.21.1 and 7.21.7 for 3 years.

7.21.8.1 The record shall include: the date of the quality assurance check; the manufacturer's name, model number, and serial number of the therapeutic radiation machine; the manufacturer's name, model number and serial number for the instrument(s) used to measure the radiation output of the therapeutic radiation machine; and the signature of the individual who performed the periodic quality assurance check.

7.21.9 Quality assurance checks for IMRT shall:

7.21.9.1 Include commissioning and testing of the treatment planning and delivery systems, routine quality assurance of the delivery system, and patient-specific validation of treatment plans;5/ and

7.21.9.2 Be performed in accordance with "Guidance document on delivery, treatment planning, and clinical implementation of IMRT: Report of the IMRT subcommittee of the AAPM radiation therapy committee: AAPM Report No. 82”; and

7.21.9.3 Be performed in accordance with the manufacturer’s contractual specifications.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-8.0** Calibration of Survey Instruments {#sec-4465-8.0 omnilex-key=us-de-regs-official--title-16--4465-8.0}

8.1 The registrant shall ensure that the survey instruments used to show compliance with 4492 (Part X) have been calibrated before first use, at intervals not to exceed 12 months, and following repair. The registrant shall check each survey instrument for consistent response with a dedicated check source before each use. The licensee is not required to keep records of these checks.

8.2 To satisfy the requirements of 8.1 the registrant shall:

8.2.1 Calibrate all required scale readings up to 10 mSv (1000 mrem) per hour with an appropriate radiation source that is traceable to the National Institute of Standards and Technology (NIST);

8.2.2 Calibrate at least 2 points on each scale to be calibrated. These points should be at approximately 1/3 and 2/3 of full-scale; and

8.3 To satisfy the requirements of 8.2 the registrant shall:

8.3.1 Consider a point as calibrated if the indicated dose rate differs from the calculated dose rate by not more than 10%; and

8.3.2 Consider a point as calibrated if the indicated dose rate differs from the calculated dose rate by not more than 20% if a correction factor or graph is conspicuously attached to the instrument.

8.4 The registrant shall retain a record of each calibration required in 8.1 for 3 years. The record shall include:

8.4.1 A description of the calibration procedure; and

8.4.2 A description of the source used and the certified dose rates from the source, and the rates indicated by the instrument being calibrated, the correction factors deduced from the calibration data, the signature of the individual who performed the calibration, and the date of calibration.

8.5 The registrant may obtain the services of individuals licensed by the Agency, the US Nuclear Regulatory Commission or an Agreement State to perform calibrations of survey instruments. Records of calibrations that contain information required by 8.4 shall be maintained by the registrant.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-9.0** Shielding and Safety Design Requirements {#sec-4465-9.0 omnilex-key=us-de-regs-official--title-16--4465-9.0}

9.1 Each therapeutic radiation machine subject to 6.0 or 7.0 shall be provided with such primary and/or secondary barriers as are necessary to ensure compliance with Part D, Sections 6.0 and 13.0 of these regulations.

9.2 Facility design information for all new installations of a therapeutic radiation machine or installations of a therapeutic radiation machine of higher energy into a room not previously approved for that energy shall be submitted for Agency approval prior to actual installation of the therapeutic radiation machine. The minimum facility design information that must be submitted is contained in Appendix A to (Part X).

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-10.0** Quality Assurance For Radiation Therapy Simulation Systems {#sec-4465-10.0 omnilex-key=us-de-regs-official--title-16--4465-10.0}

10.1 Quality assurance for a conventional or virtual simulator shall include acceptance testing and periodic verification of system performance; and

10.2 Be performed in accordance with "Comprehensive QA for Radiation Oncology: Report of AAPM Radiation Therapy Committee Task Group No.40: AAPM Report No. 46” for a conventional simulator; or

10.3 Be performed in accordance with “Quality assurance for computed tomography simulators and the computed tomography-simulation process: Report of the AAPM Radiation Therapy Committee Task Group No. 66: AAPM Report No. 83” for a virtual simulator.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-11.0** Electronic Brachytherapy {#sec-4465-11.0 omnilex-key=us-de-regs-official--title-16--4465-11.0}

11.1 Applicability. Electronic brachytherapy devices shall be subject to the requirements of 11.0 and shall be exempt for the requirements of 6.0.

11.1.1 An electronic brachytherapy device that does not meet the requirements of 11.0 shall not be used for irradiation of patients; and

11.1.2 An electronic brachytherapy device shall only be utilized for human use applications specifically approved by the U.S. Food and Drug Administration (FDA) unless participating in a research study approved by the registrant’s Institutional Review Board (IRB).

11.2 Possession of Survey Instrument(s). Each facility location authorized to use an electronic brachytherapy device in accordance with 11.0 shall possess appropriately calibrated portable monitoring equipment. As a minimum, such equipment shall include a portable radiation measurement survey instrument capable of measuring dose rates over the range 10 µSv (1 mrem) per hour to 10 mSv (1000 mrem) per hour. The survey instrument(s) shall be operable and calibrated in accordance with 8.0 for the applicable electronic brachytherapy source energy.

11.3 Facility Design Requirements for Electronic Brachytherapy Devices. In addition to shielding adequate to meet requirements of 9.0 the treatment room shall meet the following design requirements:

11.3.1 If applicable, provision shall be made to prevent simultaneous operation of more than 1 therapeutic radiation machine in a treatment room.

11.3.2 Access to the treatment room shall be controlled by a door at each entrance.

11.3.3 Each treatment room shall have provisions to permit continuous aural communication and visual observation of the patient from the treatment control panel during irradiation. The electronic brachytherapy device shall not be used for patient irradiation unless the patient can be observed.

11.3.4 For electronic brachytherapy devices capable of operating below 50 kV, radiation shielding for the staff in the treatment room shall be available, either as a portable shield and/or as localized shielded material around the treatment site.

11.3.5 For electronic brachytherapy devices capable of operating at greater than 150 kV: 6/

11.3.5.1 The control panel shall be located outside the treatment room; and

11.3.5.2 Electrical interlocks shall be provided for all door(s) to the treatment room that will:

11.3.5.2.1 Prevent the operator from initiating the treatment cycle unless each treatment room entrance door is closed;

11.3.5.2.2 Cause the source to be shielded when an entrance door is opened; and

11.3.5.2.3 Prevent the source from being exposed following an interlock interruption until all treatment room entrance doors are closed and the source on-off control is reset at the console.

11.4 Electrical Safety for Electronic Brachytherapy Devices

11.4.1 The high voltage transformer shall be electrically isolated to prevent electrical and magnetic interference with the surrounding environment and ancillary equipment.

11.4.2 The high voltage transformer shall be isolated from personnel (e.g., operator) and the environment by a protective housing that can only be accessed through a cover requiring a tool for access or with electrical interlocks to prevent operation while open.

11.4.3 The high voltage transformer shall have appropriate safety labels warning personnel of potential electrical shock and/or heat related injuries.

11.4.4 Equipment manufactured after shall be in compliance with the most current revision of the following International Electrotechnical Commission (IEC) Documents:

11.4.4.1 IEC 60601-1:1998+A1+A2:1995;

11.4.4.2 IEC 60601-1-2:2001;

11.4.4.3 IEC 60601-2-8:1999; and

11.4.4.4 IEC 60601-2-17:2004.

11.5 Control Panel Functions. The control panel, in addition to the displays required by other provisions in 11.0 shall:

11.5.1 Provide an indication of whether electrical power is available at the control panel and if activation of the electronic brachytherapy source is possible;

11.5.2 Provide an indication of whether X‑rays are being produced;

11.5.3 Provide a means for indicating electronic brachytherapy source potential and current;

11.5.4 Provide the means for terminating an exposure at any time; and

11.5.5 Include an access control (locking) device that will prevent unauthorized use of the electronic brachytherapy device.

11.6 Timer. A suitable irradiation control device (timer) shall be provided to terminate the irradiation after a pre-set time interval or integrated charge on a dosimeter-based monitor.

11.6.1 A timer shall be provided at the treatment control panel. The timer shall indicate planed setting and the time elapsed or remaining;

11.6.2 The timer shall not permit an exposure if set at 0;

11.6.3 The timer shall be a cumulative device that activates with an indication of "BEAM-ON" and retains its reading after irradiation is interrupted or terminated. After irradiation is terminated and before irradiation can be reinitiated, it shall be necessary to reset the elapsed time indicator;

11.6.4 The timer shall terminate irradiation when a pre-selected time has elapsed, if any dose monitoring system has not previously terminated irradiation.

11.6.5 The timer shall permit setting of exposure times as short as 0.1 second; and

11.6.6 The timer shall be accurate to within 1% of the selected value or 0.1 second, whichever is greater.

11.7 Qualified Medical Physicist Support

11.7.1 The services of a Qualified Medical Physicist shall be required in facilities having electronic brachytherapy devices. The Qualified Medical Physicist shall be responsible for:

11.7.1.1 Evaluation of the output from the electronic brachytherapy source;

11.7.1.2 Generation of the necessary dosimetric information;

11.7.1.3 Supervision and review of treatment calculations prior to initial treatment of any treatment site;

11.7.1.4 Establishing the periodic and day-of-use quality assurance checks and reviewing the data from those checks as required in 11.11;

11.7.1.5 Consultation with the authorized user in treatment planning, as needed; and

11.7.1.6 Performing calculations/assessments regarding patient treatments that may constitute a misadministration.

11.7.2 If the Qualified Medical Physicist is not a full-time employee of the registrant, the operating procedures required by 11.8 shall also specifically address how the Qualified Medical Physicist is to be contacted for problems or emergencies, as well as the specific actions, if any, to be taken until the Qualified Medical Physicist can be contacted.

11.8 Operating Procedures

11.8.1 Only individuals approved by the authorized user, radiation safety officer, or Qualified Medical Physicist shall be present in the treatment room during treatment;

11.8.2 Electronic brachytherapy devices shall not be made available for medical use unless the requirements of 4.1, 11.9 and 11.10 have been met;

11.8.3 The electronic brachytherapy device shall be inoperable, either by hardware or password, when unattended by qualified staff or service personnel;

11.8.4 During operation, the electronic brachytherapy device operator shall monitor the position of all persons in the treatment room, and all persons entering the treatment room, to prevent entering persons from unshielded exposure from the treatment beam;

11.8.5 If a patient must be held in position during treatment, mechanical supporting or restraining devices shall be used;

11.8.6 Written procedures shall be developed, implemented, and maintained for responding to an abnormal situation. These procedures shall include:

11.8.6.1 Instructions for responding to equipment failures and the names of the individuals responsible for implementing corrective actions; and

11.8.6.2 The names and telephone numbers of the authorized users, the Qualified Medical Physicist, and the radiation safety officer to be contacted if the device or console operates abnormally.

11.8.7 A copy of the current operating and emergency procedures shall be physically located at the electronic brachytherapy device control console7/;

11.8.8 Instructions shall be posted at the electronic brachytherapy device control console5/ to inform the operator of the names and telephone numbers of the authorized users, the Qualified Medical Physicist, and the radiation safety officer to be contacted if the device or console operates abnormally; and

11.8.9 The radiation safety officer, or his/her designee, and an authorized user shall be notified as soon as possible if the patient has a medical emergency, suffers injury or dies. The radiation safety officer or the Qualified Medical Physicist shall inform the manufacturer of the event.

11.9 Safety Precautions for Electronic Brachytherapy Devices.

11.9.1 A Qualified Medical Physicist shall determine which persons in the treatment room require monitoring when the beam is energized;

11.9.2 An authorized user and a Qualified Medical Physicist shall be physically present during the initiation of all patient treatments involving the electronic brachytherapy device;

11.9.3 A Qualified Medical Physicist and either an authorized user or a physician or electronic brachytherapy device operator, under the supervision of an authorized user, who has been trained in the operation and emergency response for the electronic brachytherapy device, shall be physically present during continuation of all patient treatments involving the electronic brachytherapy device;

11.9.4 When shielding is required by 11.3.4, the electronic brachytherapy device operator shall use a survey meter to verify proper placement of the shielding immediately upon initiation of treatment. Alternatively, a Qualified Medical Physicist shall designate shield locations sufficient to meet the requirements of Part D, Section 6.0 of these regulations for any individual, other than the patient, in the treatment room; and

11.9.5 All personnel in the treatment room are required to remain behind shielding during treatment. A Qualified Medical Physicist shall approve any deviation from this requirement and shall designate alternative radiation safety protocols, compatible with patient safety, to provide an equivalent degree of protection.

11.10 Electronic Brachytherapy Source Calibration Measurements

11.10.1 Calibration of the electronic brachytherapy source output for an electronic brachytherapy device subject to 11.0 shall be performed by, or under the direct supervision of, a Qualified Medical Physicist;

11.10.2 Calibration of the electronic brachytherapy source output shall be made for each electronic brachytherapy source, or after any repair affecting the X-ray beam generation, or when indicated by the electronic brachytherapy source quality assurance checks;

11.10.3 Calibration of the electronic brachytherapy source output shall utilize a dosimetry system described in 4.3;

11.10.4 Calibration of the electronic brachytherapy source output shall include, as applicable, determination of:

11.10.4.1 The output within 2% of the expected value, if applicable, or determination of the output if there is no expected value;

11.10.4.2 Timer accuracy and linearity over the typical range of use;

11.10.4.3 Proper operation of back-up exposure control devices;

11.10.4.4 Evaluation that the relative dose distribution about the source is within 5% of that expected; and

11.10.4.5 Source positioning accuracy to within 1 millimeter within the applicator;

11.10.5 Calibration of the X-ray source output required by 11.10 through 11.10.4 shall be in accordance with current published recommendations from a recognized national professional association with expertise in electronic brachytherapy (when available). In the absence of a calibration protocol published by a national professional association, the manufacturer’s calibration protocol shall be followed.

11.10.6 The registrant shall maintain a record of each calibration in an auditable form for the duration of the registration. The record shall include: the date of the calibration; the manufacturer's name, model number and serial number for the electronic brachytherapy device and a unique identifier for it’s electronic brachytherapy source; the model numbers and serial numbers of the instrument(s) used to calibrate the electronic brachytherapy device; and the name and signature of the Qualified Medical Physicist responsible for performing the calibration.

11.11 Periodic and Day-of-Use Quality Assurance Checks for Electronic Brachytherapy Devices

11.11.1 Quality assurance checks shall be performed on each electronic brachytherapy device subject to 11.0.

11.11.1.1 At the beginning of each day of use;

11.11.1.2 Each time the device is moved to a new room or site8; and

11.11.1.3 After each X-ray tube installation.

11.11.2 The registrant shall perform periodic quality assurance checks required by 11.11.1 in accordance with procedures established by the Qualified Medical Physicist;

11.11.3 To satisfy the requirements of 11.11.1, radiation output quality assurance checks shall include as a minimum:

11.11.3.1 Verification that output of the electronic brachytherapy source falls within 3% of expected values, as appropriate for the device, as determined by:

11.11.3.1.1 Output as a function of time, or

11.11.3.1.2 Output as a function of setting on a monitor chamber.

11.11.3.2 Verification of the consistency of the dose distribution to within 3% of that found during calibration required by 11.10; and

11.11.3.3 Validation of the operation of positioning methods to ensure that the treatment dose exposes the intended location within 1 millimeter; and

11.11.4 The registrant shall use a dosimetry system that has been intercompared within the previous 12 months with the dosimetry system described in 4.3.1 to make the quality assurance checks required in 11.11.3;

11.11.5 The registrant shall review the results of each radiation output quality assurance check according to the following procedures:

11.11.5.1 An authorized user and Qualified Medical Physicist shall be immediately notified if any parameter is not within its acceptable tolerance. The electronic brachytherapy device shall not be made available for subsequent medical use until the Qualified Medical Physicist has determined that all parameters are within their acceptable tolerances;

11.11.5.2 If all radiation output quality assurance check parameters appear to be within their acceptable range, the quality assurance check shall be reviewed and signed by either the authorized user or Qualified Medical Physicist within 2 days; and

11.11.5.3 The Qualified Medical Physicist shall review and sign the results of each radiation output quality assurance check at intervals not to exceed 30 days.

11.11.6 To satisfy the requirements of 11.11.1, safety device quality assurance checks shall, at a minimum, assure:

11.11.6.1 Proper operation of radiation exposure indicator lights on the electronic brachytherapy device and on the control console;

11.11.6.2 Proper operation of viewing and intercom systems in each electronic brachytherapy facility, if applicable;

11.11.6.3 Proper operation of radiation monitors, if applicable;

11.11.6.4 The integrity of all cables, catheters or parts of the device that carry high voltages; and

11.11.6.5 Connecting guide tubes, transfer tubes, transfer-tube-applicator interfaces, and treatment spacers are free from any defects that interfere with proper operation.

11.11.7 If the results of the safety device quality assurance checks required in 11.11.5 indicate the malfunction of any system, a registrant shall secure the control console in the OFF position and not use the electronic brachytherapy device except as may be necessary to repair, replace, or check the malfunctioning system.

11.11.8 The registrant shall maintain a record of each quality assurance check required by 11.11.3 and 11.11.7 in an auditable form for 3 years.

11.11.8.1 The record shall include the date of the quality assurance check; the manufacturer's name, model number and serial number for the electronic brachytherapy device; the name and signature of the individual who performed the periodic quality assurance check and the name and signature of the Qualified Medical Physicist who reviewed the quality assurance check;

11.11.8.2 For radiation output quality assurance checks required by 11.11.3 the record shall also include the unique identifier for the electronic brachytherapy source and the manufacturer's name; model number and serial number for the instrument(s) used to measure the radiation output of the electronic brachytherapy device.

11.12 Therapy-Related Computer Systems. The registrant shall perform acceptance testing on the treatment planning system of electronic brachytherapy-related computer systems in accordance with current published recommendations from a recognized national professional association with expertise in electronic brachytherapy (when available). In the absence of an acceptance testing protocol published by a national professional association, the manufacturer’s acceptance testing protocol shall be followed.

11.12.1 Acceptance testing shall be performed by, or under the direct supervision of, a Qualified Medical Physicist. At a minimum, the acceptance testing shall include, as applicable, verification of:

11.12.1.1 The source-specific input parameters required by the dose calculation algorithm;

11.12.1.2 The accuracy of dose, dwell time, and treatment time calculations at representative points;

11.12.1.3 The accuracy of isodose plots and graphic displays;

11.12.1.4 The accuracy of the software used to determine radiation source positions from radiographic images; and

11.12.1.5 If the treatment-planning system is different from the treatment-delivery system, the accuracy of electronic transfer of the treatment delivery parameters to the treatment delivery unit from the treatment planning system.

11.12.2 The position indicators in the applicator shall be compared to the actual position of the source or planned dwell positions, as appropriate, at the time of commissioning.

11.12.3 Prior to each patient treatment regimen, the parameters for the treatment shall be evaluated and approved by the authorized user and the Qualified Medical Physicist for correctness through means independent of that used for the determination of the parameters.

11.13 Training

11.13.1 A registrant shall provide instruction, initially and at least annually, to all individuals who operate the electronic brachytherapy device, as appropriate to the individual's assigned duties, in the operating procedures identified in 11.8. If the interval between patients exceeds 1 year, retraining of the individuals shall be provided.

11.13.2 In addition to the requirements of 3.3 for therapeutic radiation machine authorized users and 3.4 for Qualified Medical Physicists, these individuals shall also receive device specific instruction initially from the manufacturer, and annually from either the manufacturer or other qualified trainer. The training shall be of a duration recommended by a recognized national professional association with expertise in electronic brachytherapy (when available). In the absence of any training protocol recommended by a national professional association, the manufacturer’s training protocol shall be followed. The training shall include, but nor be limited to:

11.13.2.1 Device-specific radiation safety requirements;

11.13.2.2 Device operation;

11.13.2.3 Clinical use for the types of use approved by the FDA;

11.13.2.4 Emergency procedures, including an emergency drill; and

11.13.2.5 The registrant’s Quality Assurance Program.

11.13.3 A registrant shall retain a record of individuals receiving instruction required by 11.13.1 and 11.13.2 for 3 years. The record shall include a list of the topics covered, the date of the instruction, the name(s) of the attendee(s), and the name(s) of the individual(s) who provided the instruction.

11.14 Mobile Electronic Brachytherapy Service. A registrant providing mobile electronic brachytherapy service shall, as a minimum:

11.14.1 Check all survey instruments before medical use at each address of use or on each day of use, whichever is more restrictive.

11.14.2 Account for the electronic brachytherapy source in the electronic brachytherapy device before departure from the client’s address.

11.14.3 Perform, at each location on each day of use, all of the required quality assurance checks specified 11.11 to assure proper operation of the device.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-12.0** Other Use of Electronically-Produced Radiation to Deliver Therapeutic Radiation Dosage {#sec-4465-12.0 omnilex-key=us-de-regs-official--title-16--4465-12.0}

12.1 A person shall not utilize any device which is designed to electrically generate a source of ionizing radiation to deliver therapeutic radiation dosage, and which is not appropriately regulated under any existing category of therapeutic radiation machine, until:

12.1.1 The applicant or registrant has, at a minimum, provided the Agency with:

12.1.1.1 A detailed description of the device and its intended application(s);

12.1.1.2 Facility design requirements, including shielding and access control;

12.1.1.3 Documentation of appropriate training for authorized user physician(s) and qualified medical physicist(s);

12.1.1.4 Methodology for measurement of dosages to be administered to patients or human research subjects;

12.1.1.5 Documentation regarding calibration, maintenance, and repair of the device, as well as instruments and equipment necessary for radiation safety;

12.1.1.6 Radiation safety precautions and instructions; and

12.1.1.7 Other information requested by the Agency in its review of the application; and

12.1.2 The applicant or registrant has received written approval from the Agency to utilize the device in accordance with the regulations and specific conditions the Agency considers necessary for the medical use of the device.

APPENDIX A

INFORMATION ON RADIATION SHIELDING REQUIRED FOR PLAN REVIEWS

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-1.0** All Therapeutic Radiation Machines. {#sec-4465-1.0 omnilex-key=us-de-regs-official--title-16--4465-1.0}

1.1 Basic facility information including: name, telephone number and Agency registration number of the individual responsible for preparation of the shielding plan; name and telephone number of the facility supervisor; and the street address [including room number] of the therapeutic radiation machine facility. The plan should also indicate whether this is a new structure or a modification to existing structure(s).

1.2 All wall, floor, and ceiling areas struck by the useful beam shall have primary barriers.

1.3 Secondary barriers shall be provided in all wall, floor, and ceiling areas not having primary barriers.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-2.0** Therapeutic Radiation Machines up to 150 Kv (photons only). {#sec-4465-2.0 omnilex-key=us-de-regs-official--title-16--4465-2.0}

2.1 In addition to the requirements listed in Section I above, therapeutic radiation machine facilities which produce only photons with a maximum energy less than or equal to 150 kV shall submit shielding plans which contain, as a minimum, the following additional information:

2.1.1 Equipment specifications, including the manufacturer and model number of the therapeutic radiation machine, as well as the maximum technique factors;

2.1.2 Maximum design workload for the facility including total weekly radiation output, [expressed in gray (rad) or air kerma at 1 meter], total beam‑on time per day or week, the average treatment time per patient, along with the anticipated number of patients to be treated per day or week;

2.1.3 A facility blueprint/drawing indicating: scale [0.25 inch = 1 foot is typical]; direction of North; normal location of the therapeutic radiation machine's radiation port(s); the port's travel and traverse limits; general direction(s) of the useful beam; locations of any windows and doors; and the location of the therapeutic radiation machine control panel. If the control panel is located inside the therapeutic radiation machine treatment room, the location of the operator's booth shall be noted on the plan and the operator's station at the control panel shall be behind a protective barrier sufficient to ensure compliance with Part D, Section 6.0 of these regulations;

2.1.4 The structural composition and thickness or lead/concrete equivalent of all walls, doors, partitions, floor, and ceiling of the room(s) concerned;

2.1.5 The type of occupancy of all adjacent areas inclusive of space above and below the room(s) concerned. If there is an exterior wall, show distance to the closest area(s) where it is likely that individuals may be present; and

2.1.6 At least one example calculation which shows the methodology used to determine the amount of shielding required for each physical condition [i.e.: primary and secondary/leakage barriers, restricted and unrestricted areas, entry door(s)] and shielding material in the facility:

2.1.7 If commercial software is used to generate shielding requirements, please also identify the software used and the version/ revision date.

2.1.8 If the software used to generate shielding requirements is not in the open literature, please also submit quality control sample calculations to verify the result obtained with the software.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-3.0** Therapeutic Radiation Machines Over 150 kV. {#sec-4465-3.0 omnilex-key=us-de-regs-official--title-16--4465-3.0}

3.1 In addition to the requirements listed in Section I above, therapeutic radiation machine facilities that produce photons with a maximum energy in excess of 150 kV and/or electrons shall submit shielding plans which contain, as a minimum, the following additional information:

3.1.1 Equipment specifications including the manufacturer and model number of the therapeutic radiation machine, and gray (rad) at the isocenter and the energy(s) and type(s) of radiation produced [i.e.: photon, electron]. The target to isocenter distance shall be specified;

3.1.2 Maximum design workload for the facility including total weekly radiation output [expressed in gray (rad) at 1 meter], total beam‑on time per day or week, the average treatment time per patient, along with the anticipated number of patients to be treated per day or week;

3.1.3 Facility blueprint/drawing [including both floor plan and elevation views] indicating relative orientation of the therapeutic radiation machine, scale [0.25 inch = 1 foot is typical], type(s), thickness and minimum density of shielding material(s), direction of North, the locations and size of all penetrations through each shielding barrier [ceiling, walls and floor], as well as details of the door(s) and maze;

3.1.4 The structural composition and thickness or concrete equivalent of all walls, doors, partitions, floor, and ceiling of the room(s) concerned;

3.1.5 The type of occupancy of all adjacent areas inclusive of space above and below the room(s) concerned. If there is an exterior wall, show distance to the closest area(s) where it is likely that individuals may be present;

3.1.6 Description of all assumptions that were in shielding calculations including, but not limited to, design energy [i.e.: room may be designed for 6 MV unit although only a 4 MV unit is currently proposed], work‑load, presence of integral beam‑stop in unit, occupancy and use(s) of adjacent areas, fraction of time that useful beam will intercept each permanent barrier [walls, floor and ceiling] and "allowed" radiation exposure in both restricted and unrestricted areas; and

3.1.7 At least one example calculation which shows the methodology used to determine the amount of shielding required for each physical condition [i.e.: primary and secondary/leakage barriers, restricted and unrestricted areas, small angle scatter, entry door(s) and maze] and shielding material in the facility:

3.1.7.1 If commercial software is used to generate shielding requirements, also identify the software used and the version/ revision date; and

3.1.7.2 If the software used to generate shielding requirements is not in the open literature, also submit quality control sample calculations to verify the result obtained with the software.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-4.0** Neutron Shielding {#sec-4465-4.0 omnilex-key=us-de-regs-official--title-16--4465-4.0}

4.1 In addition to the requirements listed in Section III above, therapeutic radiation machine facilities that are capable of operating above 10 MV shall submit shielding plans which contain, as a minimum, the following additional information:

4.1.1 The structural composition, thickness, minimum density and location of all neutron shielding material;

4.1.2 Description of all assumptions that were used in neutron shielding calculations including, but not limited to, neutron spectra as a function of energy, neutron fluence rate, absorbed dose and dose equivalent (due to neutrons) in both restricted and unrestricted areas;

4.1.3 At least one example calculation which shows the methodology used to determine the amount of neutron shielding required for each physical condition [i.e.: restricted and unrestricted areas, entry door(s) and maze] and neutron shielding material utilized in the facility:

4.1.3.1 If commercial software is used to generate shielding requirements, also identify the software used and the version/ revision date; and

4.1.3.2 If the software used to generate shielding requirements is not in the open literature, also submit quality control sample calculations to verify the result obtained with the software.

4.1.4 The method(s) and instrumentation that will be used to verify the adequacy of all neutron shielding installed in the facility.

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

##### **16 Del. Admin. Code § 4465-5.0** References {#sec-4465-5.0 omnilex-key=us-de-regs-official--title-16--4465-5.0}

5.1 NCRP Report 49, "Structural Shielding Design and Evaluation for Medical Use of X Rays and Gamma Rays of Energies Up to 10 MeV" (1976).

5.2 NCRP Report 79, "Neutron Contamination from Medical Electron Accelerators" (1984).

5.3 NCRP Report 144, "Radiation Protection for Particle Accelerator Facilities" (2003).

5.4 NCRP Report 151, “Structural Shielding Design and Evaluation for Megavoltage X- and Gamma-Ray Radiotherapy Facilities. (2006).

**History**
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *17 DE Reg. 983 (04/01/14)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *28 DE Reg. 312 (10/01/24)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *22 DE Reg. 401 (11/01/18)*
- *16 DE Reg. 1274 (06/01/13)*
- *19 DE Reg. 140 (08/01/15)*
- *22 DE Reg. 401 (11/01/18)*
- *23 DE Reg. 306 (10/01/19)*
- *28 DE Reg. 312 (10/01/24)*
- *28 DE Reg. 667 (03/01/25)*

#### **4466** Radiation Technologists/Technicians (Certification)

##### **16 Del. Admin. Code § 4466** Radiation Technologists/Technicians (Certification) {#sec-4466 omnilex-key=us-de-regs-official--title-16--4466}

This Regulation was approved by the Authority on Radiation Protection on February 17, 1989, pursuant to 16 Del.C. §7406(b). Radiation Technologists/Technicians are subject to certification by the Authority on Radiation Protection. This Regulation is effective February 10, 2006.

**History**
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 668 (03/01/25)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 668 (03/01/25)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 313 (10/01/24)*
- *6 DE Reg. 99 (07/01/02)*
- *7 DE Reg. 639 (11/01/03)*
- *9 DE Reg. 1213 (02/01/06)*
- *17 DE Reg. 983 (04/01/14)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 668 (03/01/25)*

##### **16 Del. Admin. Code § 4466-1.0** Purpose and Scope {#sec-4466-1.0 omnilex-key=us-de-regs-official--title-16--4466-1.0}

The Authority hereby finds and declares that the citizens of the State of Delaware are entitled to the maximum protection practicable from the harmful effects of excessive and improper exposure to ionizing radiation; that the protection can be increased by requiring appropriate education and training of technologists and technicians operating medical and dental equipment and sources emitting ionizing radiation; and that it is therefore necessary to establish certification standards in radiation protection principles for these operators and to provide for their appropriate examination and certification.

**History**
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 668 (03/01/25)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 668 (03/01/25)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 313 (10/01/24)*
- *6 DE Reg. 99 (07/01/02)*
- *7 DE Reg. 639 (11/01/03)*
- *9 DE Reg. 1213 (02/01/06)*
- *17 DE Reg. 983 (04/01/14)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 668 (03/01/25)*

##### **16 Del. Admin. Code § 4466-2.0** Title of Regulation {#sec-4466-2.0 omnilex-key=us-de-regs-official--title-16--4466-2.0}

This regulation shall be known as the "Radiation Technologist/Technician Certification".

**History**
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 668 (03/01/25)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 668 (03/01/25)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 313 (10/01/24)*
- *6 DE Reg. 99 (07/01/02)*
- *7 DE Reg. 639 (11/01/03)*
- *9 DE Reg. 1213 (02/01/06)*
- *17 DE Reg. 983 (04/01/14)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 668 (03/01/25)*

##### **16 Del. Admin. Code § 4466-3.0** Severability {#sec-4466-3.0 omnilex-key=us-de-regs-official--title-16--4466-3.0}

If any provision or application of any provision of this regulation is held invalid, that invalidity shall not affect other provisions or applications of this regulation.

**History**
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 668 (03/01/25)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 668 (03/01/25)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 313 (10/01/24)*
- *6 DE Reg. 99 (07/01/02)*
- *7 DE Reg. 639 (11/01/03)*
- *9 DE Reg. 1213 (02/01/06)*
- *17 DE Reg. 983 (04/01/14)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 668 (03/01/25)*

##### **16 Del. Admin. Code § 4466-4.0** Definitions {#sec-4466-4.0 omnilex-key=us-de-regs-official--title-16--4466-4.0}

As used in this regulation:

"Agency" means the administrative agent of the Authority on Radiation Protection; i.e., the Office of Radiation Control, Division of Public Health, Department of Health and Social Services.

"ARRT" means American Registry of Radiologic Technologists. A national certifying body that credentials through a national test graduates of JRCERT approved radiologic technology programs. The ARRT also provides the State Limited Scope Licensing Examination to be used by individuals who do not meet the national registry requirements.

"ASRT" means the American Society of Radiologic Technologists, the national society of radiologic technologists and radiation therapists that establishes national practice standards and guidelines for the practice of medical imaging and therapy.

"Authority" means the Authority on Radiation Protection as specified by 16 Del.C. §7404.

“Cardiovascular radiologic technologist” means any individual, other than a licensed physician who has trained to assist with procedures that require the use of radiation invasive cardiology.

"CBRPA" means the Certification Board for Radiology Practitioner Assistants, a national certifying body that credentials, through a national test, graduates of recognized radiologist assistant programs.

"CCI" means Cardiovascular Credentialing International, a national certifying body that credentials technologists in invasive cardiovascular procedures using radiation.

"Certificate" means a document issued by the Agency recognizing the successful completion of an Authority approved certification exam. The "certificate" allows for the practice of radiation technology as specified by the level of examination the individual has passed. Other credentials include "temporary".

"Certification examination" means any examination satisfactory to the Authority that is used to determine the competency of radiation technologists/technicians in the "principles and practice of radiation protection".

“Certified dental assistant” or “CDA” means an individual holding a national credential issued by the Dental Assisting National Board (DANB).

“Chiropractic” means a drugless system of health care based on the principle that interference with the transmission of nerve impulses may cause disease, per 24 Del.C., Ch. 7, Board of Chiropractic, as amended.

"CODA" means Commission on Dental Accreditation.

"DANB" means Dental Assisting National Board which issues national credentials to eligible dental assistants.

“Dentist” shall mean a person who is qualified to practice dentistry as prescribed in 24 Del.C., Ch. 11, Dentistry and Dental Hygiene, as amended.

“ISCD” means International Society of Clinical Densitometry.

"JRCECT" means Joint Review Committee on Education in Cardiovascular Technology

"JRCERT" means Joint Review Committee on Education in Radiologic Technology

“JRCNMT” means Joint Review Committee on Nuclear Medicine Technology.

"Licensed practitioner" means an individual licensed to practice medicine, dentistry, podiatry, chiropractic, osteopathy, or veterinary medicine in this state. For the purpose of this regulation, advanced practice registered nurses (APRN) and physicians assistants (PA) may order diagnostic or supportive x-ray procedures for patients in accordance with Title 24, Delaware Code. APRNs and PAs who supervise, perform, view, or interpret x-ray procedures do so within their scope of practice, as governed by Title 24, Delaware Code.

“Medical radiologic technologist – bone densitometry only” means a certificate conferred on an individual holding a primary national credential in nuclear medicine technology or radiation therapy who subsequently passes a post-primary examination in bone densitometry.

“Medical radiologic technologist – CT only” means a certificate conferred on an individual holding a primary national credential in nuclear medicine technology or radiation therapy who subsequently passes a post-primary examination in computed tomography (CT), for purposes of performing modalities combining nuclear medicine and radiologic technology, such as PET/CT.

"NMTCB" means Nuclear Medicine Technologist Certification Board which provides national credentialing of nuclear medicine technologists.

"Nuclear medicine technologist" means an individual, other than a licensed practitioner, who uses radiopharmaceutical agents on humans for diagnostic or therapeutic purposes.

“PET/CT” means positron emission tomography/computed tomography, a medical procedure consisting of radiopharmaceutical agents combined with the use of a form of x-ray machine. This hybrid modality requires dual certification as a nuclear medicine technologist and medical radiologic technologist in this state.

"Physician" means an allopathic doctor of medicine and surgery or a doctor of osteopathic medicine and surgery who is registered and certified to practice medicine pursuant to 24 Del.C., Ch. 17, Medical Practice Act, as amended.

“Podiatrist” means a person who is qualified to practice podiatry and is licensed under 24 Del.C., Ch. 5, Podiatry, as amended.

“Principal supervisor” means the licensed practitioner responsible for use of x-ray equipment or other device generating ionizing radiation in the healing arts.

“Qualified expert” means an individual who has satisfactorily fulfilled the training and experience requirements consistent with achieving a level of competency sufficient to function effectively in the position for which registration is sought. Such individuals must demonstrate to the satisfaction of the Agency their qualifications for example, individuals certified in the appropriate field by the American Board of Radiology, or the American Board of Health Physics, or the American Board of Medical Physics, or those having equivalent qualifications. With reference to the calibration of radiation therapy equipment, an individual, in addition to the above qualifications, must be qualified in accordance with Part F and Part X of the Delaware Radiation Control Regulations, 16 DE Admin. Code 4465, as amended.

"Radiation technician" means an individual who has not graduated from an approved program in radiation technology, but has passed an Authority approved examination.

"Radiation technologist" means an individual who has successfully completed a JRCERT/JRCCVT approved or equivalent, recognized program in radiation technology and has passed a national credentialing examination in his/her field of specialization.

"Radiation technology” means the use of a radioactive substance or equipment emitting ionizing radiation on humans for diagnostic or therapeutic purposes.

"Radiation therapist" means an individual, other than a licensed practitioner, who exposes humans to ionizing radiation for therapeutic purposes.

"Radiologist" means a physician specializing in radiology certified by or board-eligible for the American Board of Radiology, the American Osteopathic Board of Radiology, the Royal College of Radiologists, or the Royal College of Physicians and Surgeons of Canada.

"Radiologist assistant" or "RA" means a radiation technologist, who has successfully completed an American Registry of Radiologic Technologists (ARRT)-recognized program for radiologist sssistants and has passed the ARRT-registered radiologist assistant examination or the Certification Board for Radiology Practitioner Assistant examination.

"Source of radiation" means a radioactive material, or any device or equipment emitting or capable of producing ionizing radiation.

“SPECT/CT” means single-photon emission computed tomography (SPECT), a nuclear medicine tomographic imaging technique using gamma rays combined with the use of a form of x-ray machine. This hybrid modality requires dual certification as a nuclear medicine technologist and medical radiologic technologist in this state.

"Temporary certificate" means a certificate issued by the Agency as a temporary authorization to practice radiation technology to any applicant who has complied with the provisions of this regulation and is scheduled for the next available national credentialing examination.

“Veterinarian” shall mean a person who has received a degree in veterinary medicine from a school of veterinary medicine, per 24 Del.C., Ch. 33, Veterinarians, as amended.

**History**
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 668 (03/01/25)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 668 (03/01/25)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 313 (10/01/24)*
- *6 DE Reg. 99 (07/01/02)*
- *7 DE Reg. 639 (11/01/03)*
- *9 DE Reg. 1213 (02/01/06)*
- *17 DE Reg. 983 (04/01/14)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 668 (03/01/25)*

##### **16 Del. Admin. Code § 4466-5.0** Legal Titles {#sec-4466-5.0 omnilex-key=us-de-regs-official--title-16--4466-5.0}

5.1 The Authority shall establish certification requirements for radiation technologists/technicians; i.e., certified dental assistant, dental radiation technician, medical radiologic technologist, medical radiation technician, nuclear medicine technologist, medical radiologic technologist – bone densitometry only, medical radiologic technologist – CT only, radiation therapist and cardiovascular radiologic technologist, and radiologist assistant. Individuals holding these certificates shall be recognized by their title.

5.2 Any technologist or technician certified under this regulation is authorized to use a source of radiation on humans for diagnostic or therapeutic purposes under the supervision of a licensed practitioner, and in accordance with the Delaware Radiation Control Regulations.

5.3 Holders of a certificate (legal title) under this regulation shall display in public view the official certificate or a verified copy in each place of regular employment.

5.4 Any radiologist assistant certified under this regulation is authorized to use a source of radiation on humans for diagnostic or therapeutic purposes under the supervision of a radiologist and in accordance with the Delaware Radiation Control Regulations (16 DE Admin. Code 4465).

5.4.1 A certified radiologist assistant may, under the supervision of a radiologist:

5.4.1.1 Perform patient assessment, and participate in patient management and patient education;

5.4.1.2 Evaluate image quality, make initial observations, and communicate observations to the supervising radiologist;

5.4.1.3 Administer contrast media or other medications at the direction of the supervising radiologist;

5.4.1.4 Perform or assist the supervising radiologist with procedures consistent with the guidelines adopted by the American Society of Radiologic Technologists.

5.4.2 A certified radiologist assistant is not authorized to provide official interpretation of imaging studies or prescribe medications or therapies.

**History**
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 668 (03/01/25)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 668 (03/01/25)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 313 (10/01/24)*
- *6 DE Reg. 99 (07/01/02)*
- *7 DE Reg. 639 (11/01/03)*
- *9 DE Reg. 1213 (02/01/06)*
- *17 DE Reg. 983 (04/01/14)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 668 (03/01/25)*

##### **16 Del. Admin. Code § 4466-6.0** Certification Process {#sec-4466-6.0 omnilex-key=us-de-regs-official--title-16--4466-6.0}

6.1 Classification of Certificates

6.1.1 Certificate (Subsection 7.1)

6.1.2 Temporary certificate (Subsection 7.2)

6.2 Application. The Agency shall accept an application for credentialing from any radiation technologist/technician who is at least 18 years of age, or who is currently enrolled in and attending an educational program in radiation technology and who pays a non-refundable application and examination fee (if applicable) established by rule of the Authority. Each application submitted must be complete, or it will be returned to the applicant.

6.2.1 Initial and renewal application fees shall be established at $50 when paid on time. Renewal fee is $100 when payment is received by the agency 1-180 days after expiration date on the certificate (based on post-mark).

6.2.2 The initial application fee shall be waived for applicants who document they are enrolled in a vocational-technical high school Dental Assisting Program in Delaware.

6.2.3 The Agency shall issue a certificate to all applicants who provide proof that they hold a current national credential from an Authority-recognized, national voluntary credentialing body, see subsection 6.3.5 of this regulation.

6.3 Examinations

6.3.1 The examination process shall be administered by test administration companies under contract to the Agency. The fee for examination shall accompany the application request, where applicable.

6.3.2 The Authority shall accept an application for certification from any applicant who discloses conviction of a felony if the application is complete and is submitted with photocopy of court documents that include charges, and disposition papers.

6.3.3 The Authority may accept, in lieu of an examination, a current credential by a recognized national voluntary credentialing body, (See subsection 6.3.5 of this regulation) issued on the basis of an examination consistent with the requirements established by the Authority, provided that the radiation protection standards to which that body adheres are at least as stringent as those established by the Authority.

6.3.4 An examinee who fails to pass the Authority-approved certification examination may be re-tested 2 times per calendar year, provided the prescribed application is submitted and examination fees for each re-examination are paid.

6.3.5 List of National Credentialing Organizations Acceptable for Delaware Certification

6.3.5.1 American Registry of Radiologic Technologists (ARRT)

6.3.5.2 Dental Assisting National Board (DANB)

6.3.5.3 Nuclear Medicine Technologist Certification Board (NMTCB)

6.3.5.4 Cardiovascular Credentialing International (CCI)

6.3.5.5 International Society of Clinical Densitometry (ISCD)

6.3.5.6 Certification Board of Radiology Practitioner Assistants (CBRPA)

**History**
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 668 (03/01/25)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 668 (03/01/25)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 313 (10/01/24)*
- *6 DE Reg. 99 (07/01/02)*
- *7 DE Reg. 639 (11/01/03)*
- *9 DE Reg. 1213 (02/01/06)*
- *17 DE Reg. 983 (04/01/14)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 668 (03/01/25)*

##### **16 Del. Admin. Code § 4466-7.0** Issuing Certification {#sec-4466-7.0 omnilex-key=us-de-regs-official--title-16--4466-7.0}

7.1 The Agency may issue a certificate to each qualified applicant who has successfully met the requirements under Section 6.0 of this regulation, is at least 18 years of age, and has paid the prescribed fees, (Schedule A). Furthermore, the certificate shall be issued upon verifying that the applicant has passed a certification examination acceptable to the Authority (see subsection 6.3 of this regulation). The initial certificate shall expire after a period of 3 years from date of issue. Certificates based on national credentials will automatically terminate if the national credentials are permitted to lapse, or are revoked.

7.2 Temporary Certificate. The Agency may issue a temporary certificate to a student enrolled in a post-secondary accredited school of radiation technology who is approved to take a national credentialing exam. Only 1 temporary certificate may be issued if the Agency finds that it will not violate the purpose of this regulation or endanger the public health and safety. The temporary certificate shall grant the same rights as the credential for which the applicant is awaiting examination. Such temporary certificate may not be renewed by the Agency without the approval of the Authority and only for just cause. The temporary certificate shall expire:

7.2.1 On the date of notification of the results of the certification examination; or,

7.2.2 On the certification examination date if the applicant does not take the examination; or,

7.2.3 In any case, after a maximum of 90 days from the date of issue.

7.3 Renewal of Certificate. A valid certificate may be renewed by the Agency for a period of 3 years upon payment of a renewal fee (see Schedule A) established by the Authority. Applicants for renewal of certificates based on national credentials must provide proof that the national credentials are currently valid. A photocopy of the national credential membership card or certificate in good standing is the proof required.

7.4 A radiation technologist/technician whose certificate expires is not permitted to administer radiation to human patients until the expired certificate is renewed.

7.5 A radiation technologist/technician whose certificate has lapsed for a period of less than 180 days shall apply for renewal provided that the radiation technologist/technician presents evidence of having previously passed a certification examination approved by the Authority and pays the prescribed renewal fee.

7.6 Re-certification of Lapsed Certificate. A radiation technologist/technician whose certificate has lapsed for more than 180 days shall:

7.6.1 Apply for re-certification,

7.6.2 Apply to take the appropriate certification examination, show proof of having passed an examination acceptable to the Authority, or show proof of currently valid national credentials,

7.6.3 Pay the re-certification fee and re-examination (if applicable) fee.

7.7 A radiation technologist/technician whose certificate has expired shall not expose humans to ionizing radiation until and unless the radiation technologist/technician is re-certified. Failure to comply with this requirement will subject the technician’s/technologist's employer to citation under the Delaware Radiation Control Regulations (16 DE Admin. Code 4465).

7.8 The Agency may issue verification of certification to each applicant seeking to have their Delaware certificate recognized for licensure by another state, upon receipt of a complete, official application form, and payment of the prescribed application fee.

7.9 An approved applicant whose check for fee payment is returned marked insufficient funds, account closed, or payment stopped shall remit to the agency a money order or check for guaranteed funds (cashier’s check or money order) in the amount of the application or examination fee plus the returned check fee within 30 days of the date of receipt of the agency’s notice. Otherwise, the application and the approval shall be invalid.

**History**
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 668 (03/01/25)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 668 (03/01/25)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 313 (10/01/24)*
- *6 DE Reg. 99 (07/01/02)*
- *7 DE Reg. 639 (11/01/03)*
- *9 DE Reg. 1213 (02/01/06)*
- *17 DE Reg. 983 (04/01/14)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 668 (03/01/25)*

##### **16 Del. Admin. Code § 4466-8.0** Limitations of Certification {#sec-4466-8.0 omnilex-key=us-de-regs-official--title-16--4466-8.0}

8.1 Nothing in the provisions of this regulation relating to radiation technology shall apply to the practice of licensed practitioners herein defined.

8.2 The requirement for certification shall not apply to a student enrolled in and attending an accredited school of radiation technology who applies ionizing radiation to humans in such an educational program while under the supervision of a certified radiation technologist.

8.3 A certificate, registration or license issued by another state will not be accepted as a valid equivalent radiation technologist/technician certification by the Authority.

**History**
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 668 (03/01/25)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 668 (03/01/25)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 313 (10/01/24)*
- *6 DE Reg. 99 (07/01/02)*
- *7 DE Reg. 639 (11/01/03)*
- *9 DE Reg. 1213 (02/01/06)*
- *17 DE Reg. 983 (04/01/14)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 668 (03/01/25)*

##### **16 Del. Admin. Code § 4466-9.0** Discipline, Sanctions, Hearing Procedures, and Appeals {#sec-4466-9.0 omnilex-key=us-de-regs-official--title-16--4466-9.0}

9.1 Grounds for Denial of a Certificate or Discipline of a Certificate Holder

9.1.1 Any denial of an application for a certificate or discipline of a certificate holder may be made by the Authority or the Agency based upon any of the following:

9.1.1.1 Any false or misleading statement or nondisclosure of any information requested during the application or renewal process or during any investigation of the certificate holder;

9.1.1.2 Any prior discipline or administrative action against the applicant or certificate holder by any agency or jurisdiction including but not limited to Delaware of or concerning the applicant's or certificate holder's actions or inactions in connection with performance as a radiation technologist or similar occupation;

9.1.1.3 Any plea of guilty or nolo contendere to or any conviction of any felony or class A misdemeanor or any crime substantially related to the practice involving radiation technology; a pardon does not affect the application of the foregoing;

9.1.1.4 Any dishonorable, unethical or other conduct likely to deceive, defraud or harm the public;

9.1.1.5 The practice of radiation technology or other activity regulated by the Authority without a certificate or other authorizing document or under a false or assumed name;

9.1.1.6 Misconduct, including but not limited to sexual misconduct, incompetence, or gross negligence or pattern of negligence in the practice of radiation technology or other activity regulated by the Authority;

9.1.1.7 Assisting an unauthorized person to practice any activity for which you hold a certificate;

9.1.1.8 Any physical or mental impairment which substantially limits the ability to perform the essential functions of the practice which is authorized by the certificate; with or without reasonable accommodation;

9.1.1.9 Conduct that would constitute a crime substantially related to the practice for which a certificate has been issued, or the practice of radiation technology;

9.1.1.10 Has engaged in any unprofessional conduct, or the willful neglect of a patient;

9.1.1.11 The practice for which a certificate has been applied for or has been issued under a false or assumed name or identity;

9.1.1.12 Excessive use or abuse of drugs including alcohol;

9.1.1.13 Any false, fraudulent, or forged statement or document or the use of any fraudulent, deceitful, dishonest, or unethical practice in connection with the practice regulated by the Authority;

9.1.1.14 Any other dishonorable or unprofessional actions or inactions which would bring disrepute upon the profession or activity regulated by the Authority or for which you hold a certificate issued by the Authority.

9.2 Sanctions. The Authority on Radiation Protection may take any of the following actions singly or in combination when it finds a certificate holder or an applicant has violated any of the provisions of subsections 9.1 through 9.1.1.14 or the Rules or Regulations of the Authority:

9.2.1 Revocation of the certificate to practice;

9.2.2 Suspension of the certificate for a defined period of time;

9.2.3 Suspension of the certificate to practice upon conditions until the certificate holder provides proof that the conditions for which the suspension was issued no longer exist or have been met;

9.2.4 Public or private censure of the certificate holder;

9.2.5 Issuance of a Letter of Reprimand;

9.2.6 Denial of an application for a certificate;

9.2.7 Refusal to renew a certificate;

9.2.8 Such other and further relief as may be warranted including but not limited to the actions under 16 Del.C. §§7412; 7413; 7416; 7415.

9.3 Authority Proceedings

9.3.1 The Agency may, upon a written complaint or upon its own initiative, investigate whether a certificate holder or applicant has engaged in conduct which might result in sanctions.

9.3.2 The Agency shall investigate such complaint and take such evidence as it deems appropriate and may subpoena records and documents relating thereto.

9.3.3 A copy of the Complaint shall be provided to the certificate holder or applicant who shall have 20 days to provide a written response.

9.3.4 If at the conclusion of the investigation and consideration of the response, if any, the Agency determines that a formal complaint shall be issued upon the certificate holder, it shall provide a copy of the complaint to the Authority.

9.3.5 If the Authority determines that a complaint should be issued then the Agency shall notify the alleged violator of the complaint and offer the alleged violator the opportunity for a hearing, which must be requested within 30 days of the date of notification. If the alleged violator does not timely request a hearing, the proposed sanctions shall become final. If the alleged violator makes a timely request for a hearing, the Authority shall schedule the hearing and give the alleged violator at least 30 days’ notice prior to the date fixed for the hearing.

9.3.6 In all proceedings herein:

9.3.6.1 The alleged violator may be represented by counsel who shall have the right of examination and cross-examination.

9.3.6.2 The alleged violator and the Agency may subpoena witnesses. Subpoenas shall be issued by the Chairman or Vice Chairman of the Authority upon written request.

9.3.6.3 Testimony before the Authority shall be under oath. Any member of the Authority shall have power to administer oaths for this purpose.

9.3.6.4 A stenographic record of the hearing shall be made by a qualified court reporter. At the request and expense of either party such record shall be transcribed with a copy to the other party.

9.3.6.5 The decision of a majority of the members of the Authority who are present and constitute a quorum shall be based upon a preponderance of the evidence. If the charges are supported by such evidence, the Authority may impose any sanction provided for herein. The discussion by the members of the Authority and the vote shall be in public session.

9.3.6.6 The written decision of the Authority will be sent to the alleged violator and his/her counsel by certified mail.

9.3.6.7 The Agency shall notify the employer of the alleged violator of any final order of the Authority regarding any action taken against the certification of that employee by registered, return receipt mail.

9.4 Appeals

9.4.1 Any final order entered in any proceeding by the Authority shall be subject to judicial review by the Delaware Superior Court per 16 DeI.C. §7412(c).

9.4.2 Appeals shall be handled in accordance with Delaware Superior Court Civil Rule 72.

9.5 Unlawful Practice of Radiation Technology. No person shall practice or offer to practice radiation technology or claim to be a registered or certified radiation worker in Delaware, or shall use any title, abbreviation, sign, card, or device to indicate that such person is certified pursuant to this regulation unless such person is actually certified by the Authority.

The fees listed above in Schedule A apply to each type of certificate. See Section 5.0 and Section 7.0.

1. American Registry of Radiologic Technologists (ARRT)

2. Dental Assisting National Board (DANB)

3. Nuclear Medicine Technologist Certification Board (NMTCB)

4. Cardiovascular Credentialing International (CCI)

5. International Society Clinical Densitometry (ISCD)

**History**
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 668 (03/01/25)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 668 (03/01/25)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 313 (10/01/24)*
- *6 DE Reg. 99 (07/01/02)*
- *7 DE Reg. 639 (11/01/03)*
- *9 DE Reg. 1213 (02/01/06)*
- *17 DE Reg. 983 (04/01/14)*
- *28 DE Reg. 313 (10/01/24)*
- *28 DE Reg. 668 (03/01/25)*

#### **4467** Sanitation of Recreational Camps

##### **16 Del. Admin. Code § 4467-1.0** Preamble {#sec-4467-1.0 omnilex-key=us-de-regs-official--title-16--4467-1.0}

1.1 These Regulations as amended are approved by the Division of Public Health on February 27, 1989, pursuant to the authority invested by 16 Del.C. §122(3) a, b, c, d and g. These Regulations, as amended, provide a system of inspection of such facilities and establish procedures for their enforcement.

1.2 These Regulations, as amended, supersede regulations previously adopted by the Division of Public Health and have an effective date of April 1, 1989.

**History**
- *Camp Operator Date Inspected by*

##### **16 Del. Admin. Code § 4467-2.0** Introduction {#sec-4467-2.0 omnilex-key=us-de-regs-official--title-16--4467-2.0}

Expanding leisure time, growing interest in outdoor recreation, rising standards of living and increased mobility make it possible for more people to seek and utilize recreational camps. To prevent the existence of adverse conditions, and to achieve and maintain such levels of environmental quality as will protect and promote public health, safety and general welfare, the establishment and enforcement of minimum standards in the form of regulations are established by the Division of Public Health. These Regulations provide a system of inspections of such recreational camps and establish procedures for their enforcement.

**History**
- *Camp Operator Date Inspected by*

##### **16 Del. Admin. Code § 4467-3.0** Purpose {#sec-4467-3.0 omnilex-key=us-de-regs-official--title-16--4467-3.0}

3.1 It is hereby declared that the purpose of this part is to protect, preserve and promote the physical and mental health and social well-being of the people; to minimize the incidence of communicable disease; to regulate publicly and privately owned recreational camps for the purpose of maintaining adequate sanitation and public health; and promote the general welfare of the people by this Regulation.

3.2 To prevent the existence of adverse conditions, and to achieve and maintain such levels of environmental quality that will protect and promote public health and the general welfare, establishment and enforcement of such standards are required.

**History**
- *Camp Operator Date Inspected by*

##### **16 Del. Admin. Code § 4467-4.0** Application And Scope {#sec-4467-4.0 omnilex-key=us-de-regs-official--title-16--4467-4.0}

The requirements of this part shall apply to the construction, alteration, addition, establishment, maintenance and/or operation of recreational camps.

**History**
- *Camp Operator Date Inspected by*

##### **16 Del. Admin. Code § 4467-5.0** Severability {#sec-4467-5.0 omnilex-key=us-de-regs-official--title-16--4467-5.0}

If any provision or application of any provision of these Regulations is held invalid, that invalidity shall not affect other provisions or applications of these Regulations.

General Provisions

**History**
- *Camp Operator Date Inspected by*

##### **16 Del. Admin. Code § 4467-6.0** Definitions {#sec-4467-6.0 omnilex-key=us-de-regs-official--title-16--4467-6.0}

The following words and terms, when used in these Regulations, shall have the following meaning unless the context clearly indicates otherwise:

“Camp” means a property consisting of a tract of land and all tents, vehicles, buildings, or other structures pertaining to it used as living quarters or shelter, which is operated gratuitously or for compensation.

“Camp Director” means the individual who has the primary responsibility for health matters, food, staff supervision, the administration of program operations, and supportive services, such as business and transportation.

“Camping” means a sustained experience which provides a creative, recreational and educational opportunity in group living in the out of doors. It utilizes trained leadership and the resources of natural surroundings to contribute to each camper’s mental, physical, social and spiritual growth.

“Counselor” means an individual who has a supervisory role in a youth camp.

“Day Camp” means a camp operated on a campsite for any part of the day but less than 24 hours a day for at least six days or more per year for six or more day campers per year. This does not include day care centers as defined and licensed by the Department of Services for Children, Youth and Their Families.

“Dependent Camp Site” means a plot of ground with no sewage disposal or water service hookups and designed for the accommodation of a dependent camping vehicle or tent.

“Hostel” means a building where sleeping space and/or meals are offered for a fee on a daily basis for persons who are involved in a recreational experience.

“Independent Camp Site” means a plot of ground that is provided with sewer, water and electrical hookups that is designated for the accommodation of one independent camping vehicle.

“Permit” means a written permit as required under Section 7.0.

“Person” means any camp owner or operator and shall include any individual, firm, partnership, company, corporation, trustee, association, municipality, county authority, the State, or any public or private entity conducting, controlling, managing or operating a camp as defined herein.

“Primitive or Outpost Camp” means a permanent camp premises or other site at which the basic needs for camp operation such as places of abode, water supply systems and permanent toilet and cooking facilities are not usually provided.

“Recreational Camp” means a camp for travel, recreation or vacation use operated on a campsite by the same or different persons for six days or more per year on a mutual or prorate basis, for six-day or resident campers.

“Refuse” means all solid waste materials, including garbage, rubbish, and ashes, etc.

“Residential Camp” means a camp operating on a permanent campsite for six or more consecutive 24-hour periods.

“Service Building” means a building housing toilet, bathing, laundry and/or other sanitary facilities.

“Division of Public Health” means the Secretary of the Department of Health and Social Services and the Director of the Division of Public Health or an authorized agent of the Board.

“Swimming and Diving Areas” means and includes those aquatic facilities and operations generally known as swimming pools, wading pools, diving tanks, beaches, rivers, lakes, other natural bodies of water, and similar areas and facilities.

“Tent” means any shelter of which 25 percent or more of the walls or roof or both are constructed of, or covered or protected by, canvas or any other fabric material.

“Travel Camp” means a camp which provides care for not less than a 48-hour period and which uses motorized transportation to move campers as a group from one site to another.

“Travel Trailer” means a vehicular portable structure built on a chassis, designed as a temporary dwelling for travel, recreational, and vacation use, usually identified “Travel Trailer” by the manufacturer. When factory equipped for the road, of body width not exceeding eight (8) feet and of any length providing its gross weight does not exceed 4,500 pounds, or of any weight provided its body length does not exceed 32 feet.

“Troop Camp” means a camp which provides care for not less than a 24-hour period for organized groups of campers sponsored by a voluntary organization serving children and youth. If a Troop Camp is operated as a primitive, residential, travel, or trip camp, the regulations governing that specific type of camp shall apply.

“Youth Camp” means any day camp, primitive or outpost camp, residential camp, travel camp, or troop camp on public or private land which is conducted for the same 6 or more campers under 18 years of age. It shall include programs and/or activities promoted or advertised as a “youth camp” regardless of the programs advocated and shall also include sites and facilities primarily designed for other purposes such as, but not limited to, schools, playgrounds, resorts, wilderness areas, and governmental lands.

**History**
- *Camp Operator Date Inspected by*

##### **16 Del. Admin. Code § 4467-7.0** Pre-operational Requirements {#sec-4467-7.0 omnilex-key=us-de-regs-official--title-16--4467-7.0}

7.1 General

7.1.1 No person shall establish, promote, conduct, advertise or maintain a recreational camp without a permit issued by the Division of Public Health. No recreational camp shall be established until legible and detailed plans (in duplicate) have been submitted to the Bureau of Environmental Health, Division of Public Health, Dover, and have been approved in writing. A camp as defined in this regulation shall advertise and operate only as the type of camp for which a permit has been issued.

7.1.2 Specialized services shall not be advertised unless the camp has suitable facilities and staff members qualified to offer such specific services.

7.2 Classification of Recreational Camp Permits

7.2.1 Annual Permit May be issued from date of satisfactory compliance to the end of the calendar year, when and if the Division of Public Health determines that the recreational camp operation is in compliance with this Regulation.

7.2.2 Provisional Permit May be issued when and if the Division of Public Health determines that a violation of these Regulations exists, no health hazards are present, and the owner or operator demonstrates proof of intention to correct within a specified period of time, those items which do not meet permit requirements, a provisional permit shall be issued. A provisional permit shall be issued for a 30 day period, with possible extension to a maximum of 60 days and shall be non-renewable. Provisional permits shall be replaced with an annual permit when it has been determined by inspection that the camp is in compliance with these Regulations.

7.2.3 Each permit shall specify maximum number of campers, staff and families that may be served; the name of the camp owner or operator; and the specific site(s) where the camp may operate. The permit shall be posted in a conspicuous place in the camp.

7.3 Primitive, Travel and Trip Camps

7.3.1 The Division of Public Health will issue a permit on the basis of the proposed itinerary(ies) and evidence of compliance with the applicable sections of these Regulations.

7.4 Issuance of Permits

7.4.1 Any person desiring to operate a camp shall make written application for a permit on forms provided by the Division of Public Health. Such application shall include the name and address of the owner, the location and type of the proposed camp operations and the signature of each applicant.

7.4.2 Prior to approval of an application for a permit, the Regulatory Authority shall inspect the proposed camp operations to determine compliance with the requirements of these Regulations.

7.4.3 The Regulatory Authority shall issue a permit to the applicant if its inspection reveals that the proposed camp operations comply with the requirements of these Regulations.

7.4.4 Such permit shall be renewed annually and shall not be transferable.

7.5 Submission of Plans

7.5.1 Sanitary Facilities for New Camps and Modification of Existing Camps. Duplicate copies of plans and specifications for the construction, reconstruction, or extensive alteration of any plumbing system, water supply, sewage system, garbage or refuse disposal system, kitchen, food service or dining facilities, swimming and/or diving area at any camp shall be submitted to the Division of Public Health for review at least 60 days prior to the initiation of construction and shall contain at least the following information:

7.5.1.1 name and address of owner or operator of camp;

7.5.1.2 location, boundaries and dimensions of campsite and lots;

7.5.1.3 entrance and exit roads, access roads, and trails;

7.5.1.4 location, use and floor plans of all proposed or existing buildings; detailed

7.5.1.5 plans and specifications of swimming pools; and other swimming areas;

7.5.1.6 location of all proposed or existing water supplies and sewage systems;

7.5.1.7 source and method of protecting the water supply;

7.5.1.8 method of storm water drainage;

7.5.1.9 method of storage, collection, and disposal of solid wastes;

7.5.1.10 location and number of sanitary conveniences including toilets, water closets, privies, urinals, showers, bathtubs, and handwashing facilities;

7.5.1.11 a topographical map showing the relief of the land surface, location of all lakes, ponds, swamps, sink holes, abandoned wells, rivers, streams, abandoned quarries, and forests;

7.5.1.12 method of ventilation of sleeping quarters and food service facilities; and

7.5.1.13 floor plans and equipment layout of all food service equipment and facilities.

7.5.2 Plans for plumbing must be submitted to the plumbing inspector and plumbing is to be done by a licensed plumber.

7.5.3 The Division of Public Health may declare a campsite unsatisfactory for camping purposes if, after review of the plans and a visit to the proposed site, conditions are found to exist which are hazardous or dangerous or which are in violation of the Regulations.

7.5.4 The licensee shall notify the Division of Public Health upon the completion of construction of a camp on a new site.

7.6 Post-construction Inspection. Whenever plans and specifications are required by Section 48-1.204 of these Regulations, the Regulatory Authority shall inspect the camp prior to the start of operation, to determine compliance with the approved plans and specifications and with the requirements of these Regulations. The post-construction inspection report shall indicate compliance with the plans and specifications as approved by the Regulatory Authority. All construction, conversions or repairs must be completed before a permit may be issued.

7.7 Pre-operational Inspection. The Regulatory Authority shall inspect a camp prior to the start of operations to determine compliance with the requirements of these Regulations, as follows:

7.7.1 Following completion of a satisfactory post-construction inspection, a newly constructed, converted, or physically altered facility, or reopening of a facility that has been closed for thirty (30) days, shall be in a minimum of 90% compliance with these Regulations in order to be approved for an annual operating permit.

7.7.2 Change of ownership, management firm or lessee of an existing operating facility:

7.7.3 A new operating permit is required.

7.7.4 The facility shall be in a minimum of 90% compliance with these Regulations in order to be approved for an annual operating permit.

7.7.5 The new owner, management firm or lessee may be granted a provisional permit to operate in accordance with Section 48-1.202(b), pending completion of the requirement for an annual operating permit.

7.7.6 The new owner, management firm or lessee may request a variance from certain requirements in accordance with Section 48-13.215 of these Regulations.

**History**
- *Camp Operator Date Inspected by*

##### **16 Del. Admin. Code § 4467-8.0** General Sanitation-Camps {#sec-4467-8.0 omnilex-key=us-de-regs-official--title-16--4467-8.0}

8.1 Site Location. Camps shall be accessible at all times during the designated camping season. The topography shall permit complete drainage of storm water; when this is impossible, the camp area should be artificially drained. All natural hazards, such as sink-holes, pits, abandoned excavations, etc., shall be fenced or posted to reduce accidents.

8.2 Building and Living Shelters.

8.2.1 Camp structure and facilities shall comply with applicable State and local building and zoning codes, including the plumbing code.

Every building, structure, tent, cabin, and premises shall be kept in good repair and shall be maintained in a safe and sanitary condition.

8.2.2 Where floors are provided in buildings, tents, or other structures used for sleeping quarters, they shall be easily cleanable and in good repair, shall be constructed and maintained in a safe condition, and shall afford adequate protection against inclement weather.

8.3 Shelters for Residential Camps and Hostels

8.3.1 In all permanent buildings, structures or tents, sleeping space shall be so arranged to provide a minimum of 50 square feet of floor area per person and 2 feet between each bunk. Beds shall be arranged for head-to-foot or foot-to-foot sleeping.

8.3.2 Each camper shall be provided with sleeping space and a separate space for clothing and personal belongings. Mattresses or sleeping bags that are rented or provided to the camper are to be of the type that have non-absorbent covers and are cleaned and sanitized after use by one camper and/or before it is used again.

8.3.3 All buildings used as sleeping quarters shall have a minimum ceiling height of 7 feet.

8.4 Lighting. Each habitable room in a camp shall be provided with at least one ceiling type light fixture and at least one separate floor or wall type convenience outlet. Laundry, toilet rooms and rooms where people congregate shall contain at least one ceiling or wall type fixture. Light levels in toilet and storage rooms shall be at least 20 foot candles, 30 inches from the floor. Other rooms including kitchens and living quarters, shall have light level of at least 30 foot candles, 30 inches from the floor. All electrical installations must meet the requirements of the State Board of Electrical Examiners.

8.5 Rodent and Insect Control

8.5.1 Adequate measures for the control of insects and rodents which the Division of Public Health deem a public health hazard shall be taken. All exterior openings shall be screened. Doors are to be self-closing and open outward.

8.5.2 Extermination methods and other measures to control rodents and insects shall conform with the requirements of the Division of Public Health

8.6 Weed Control

8.6.1 The growth of brush, weeds, grass and plants shall be controlled in central camp areas to prevent harborage of ticks, chiggers and other insects of public health importance.

8.6.2 The camp area shall be maintained to prevent growth of ragweed, poison ivy, poison oak and other noxious plants considered detrimental to health.

8.7 Day Camp Shelters. Inclement weather provisions shall include shelter, on or off-site, sufficiently large to house and provide for ongoing camp activities.

8.8 Tent Camps/Travel Trailers. Shall have a minimum dimension of 25 feet x 25 feet for each space, with each unit being 15 feet apart. Any structures attached to tent or trailers, such as carports, awnings or storage sheds should be considered as part of the unit when determining clearances.

**History**
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##### **16 Del. Admin. Code § 4467-9.0** General Supervision {#sec-4467-9.0 omnilex-key=us-de-regs-official--title-16--4467-9.0}

9.1 Ratio of Counselor to Campers

9.1.1 Residential Camps shall have one counselor to 10 campers. Day Camps shall have one counselor to six campers under age 6; one counselor to nine campers under age 8; one counselor to 10 campers 8 years and older.

9.1.2 Primitive and Travel Camps shall have one counselor to 10 campers, with a minimum of two counselors. A maximum of 25 percent of the counselors may include individuals 16 and 17 years of age, provided that these individuals have proper training and supervision.

9.2 Camp Director.

9.2.1 It is recommended that each residential and day camp shall have a camp director on the premises who shall meet at least two of the following criteria:

9.2.1.1 be at least 25 years of age for residential or 21 years of age for day campers;

9.2.1.2 have successfully completed a course in camping administration such as those offered by national professional camping associations, national agencies, or their equivalent; or

9.2.1.3 have had at least two season’s previous experience as part of the administrative staff of a youth camp.

9.2.2 In addition, the director should possess and demonstrate proof of previous experience in supervising a youth group in similar camping activities. Each Primitive and Travel Camp shall have a counselor accompany the campers who shall be at least 18 years old.

9.3 Supervision of Specialized Activities. When campers participate in specialized or high-risk activities such as, but not limited to, horseback riding, hiking, scuba diving, canoeing, and aquatic events, the counselors supervising the activity should possess evidence of appropriate training and experience in their program specialties. When applicable, adequate provisions shall be made to assure any special training necessary for camp personnel to protect the safety and health of handicapped campers.

9.4 Aquatic activities, including those events associated with swimming, boating, canoeing, watercraft and water skiing shall be directed by individuals currently certified as Red Cross Water Safety Instructors or YMCA Aquatic Instructor or the equivalent. When the aquatics director supervises two or more aquatic staff members, the director shall be at least 18 years of age.

9.5 Swimming activity supervision, in addition to the aquatics director, shall include a minimum ratio of one person with at least an Advanced Life Saving Certificate as issued by the American National Red Cross or YMCA Life Saving and Life Guarding Certificate per 30 campers in the water. There shall be a minimum of one to ten total staff to camper ratio maintained at all times.

9.6 All watercraft activities shall be supervised by a minimum of one counselor on the water to each 12 campers in watercraft. Said counselor shall possess at least one of the following criteria:

9.6.1 have participated in three white water canoe or raft trips totaling at least 6 hours on the water;

9.6.2 have had at least six hours of practical instruction in survival and stream safety as taught by the American National Red Cross or its equivalent; or

9.6.3 one counselor must hold a current American Red Cross Small Craft Certificate. All counselors and campers are to wear PFD’s while on the water.

9.6.4 Youth campers shall possess at least an American National Red Cross Advanced Beginner Swimming Certificate, American National Red Cross Survival Swimming Certificate, or its equivalent before being allowed to participate in salt water boating activities.

9.7 Fishing and shoreline activities shall be supervised.

9.8 Scuba diving activities shall be supervised by individuals who are currently certified by a national or regionally acceptable scuba training program.

9.9 Firearm activities shall be supervised by an individual who possesses a current National Rifle Association instructor’s care or its equivalent. In addition, a ratio of one counselor per 10 campers on the range shall be maintained at all times.

9.10 Archery activities shall be supervised by an individual who possesses a current certificate as issued by a national or regional professional archery association.

**History**
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##### **16 Del. Admin. Code § 4467-10.0** General Health {#sec-4467-10.0 omnilex-key=us-de-regs-official--title-16--4467-10.0}

10.1 General Health. Health Records and 48-4.103 Injury and Illness Reports shall not apply to tent camps, travel trailer camps or hostels.

10.2 Health Records.

10.2.1 Residential and Day Camper’s records shall be readily available and shall include:

10.2.1.1 camper’s name and address;

10.2.1.2 name, address and telephone number of parent, legal guardian, or designated adult emergency contact; and

10.2.1.3 authorization from the parent/guardian of all emergency medical care.

10.2.2 Every camper and staff member entering camp (except those entering Day Camps) shall furnish a health history and a report of a physical examination which has been performed by a qualified physician within the preceding 12 months. The health history and physical examination should emphasize those potential conditions for which camp personnel should be prepared. Each staff member and camper shall provide evidence of current immunizations for tetanus and diphtheria within the last 10 years. Proof of immunization for measles, rubella and mumps should be shown for all staff and campers born after 1958.

10.2.3 Every camper shall receive a health screening not later than 48 hours after arrival at camp by resident health service personnel.

10.2.4 If there are religious objections to physical examinations or immunizations, the camper or staff member shall submit a written statement, signed by parents or legal guardian for campers, to the effect that the individual is in good health.

10.2.5 All records shall be on file in camp for review by the licensing personnel.

10.2.6 Day campers shall not be required to furnish a report of physical examination; however, a medical history, including allergies, other health conditions, and current immunizations shall be required and kept on file at the camp.

10.2.7 The camps shall maintain a record of all employees which shall include at least:

10.2.7.1 name, address, age, training, education experience; and

10.2.7.2 other qualifications and the names and telephone number of persons to be notified in the event of an emergency.

10.3 Injury and Illness Reports

10.3.1 If an injury or illness is judged to be serious by the individual in charge of health supervision, the camp physician shall be consulted immediately. When the patient is a minor, the parents or guardian shall be notified as soon as possible.

10.3.2 A medical log listing date, name of patient, ailment, and treatment prescribed shall be maintained at the camp.

10.3.3 Except for Day Camps, an appropriate report form shall be completed in duplicate for each injury, illness, or fatality which occurs at camp, and which is attended by a physician or nurse and as a result of which the child (1) is sent home, or (2) is admitted to a hospital, or (3) has either laboratory analyses or x-rays performed which result in a positive diagnosis. The original report form shall be maintained at the camp or sponsoring organization for at least 1 year for the purposes of these Regulations. A copy shall be forwarded to the Division of Public Health not later than 1 month after the event comes to the attention of camp or medical authorities.

10.4 Communicable Diseases to be Reported. Appendix A is a list of reportable diseases; the occurrence of suspected occurrence of these diseases shall be reported to the County Health Officer within 48 hours of recognition. Reports shall be made by telephone or in writing except for certain specified diseases as indicated by a (T) which shall be reported immediately by telephone. This shall be the duty of the permit holder when made aware of such reportable disease. The provisions of the Communicable Disease Regulations of the Division of Public Health shall be followed.

10.5 Health Staff

10.5.1 There shall be a qualified person on duty at all times who is charged with health supervision. Said adult may be a licensed physician, a licensed physician’s assistant, a registered nurse, licensed practical nurse, and/or an individual who has completed at least the Standard First Aid and Personal Safety Course as presented by the American National Red Cross or its equivalent.

10.5.2 Primitive, Travel and Trip Camps shall have at least one individual in addition to the health supervisor accompanying the camp who is adequately trained to render first aid. Said individual shall possess at least a certificate of completion of the Basic First Aid Course as presented by the American National Red Cross or its equivalent.

10.6 Medication. Medication prescribed for campers or staff members shall be kept in the original containers bearing the pharmacy label and stored in a locked cabinet and in an area not accessible to the children. When no longer needed, medications shall be returned to parents, staff member, or destroyed.

10.7 First Aid Supplies

10.7.1 First aid supplies shall be available to staff in all recreational camps at food service operations, all program areas, in motor vehicles, and office maintenance areas. In addition, first aid supplies shall be readily available to staff enroute to Primitive, Travel, and Trip Camps.

10.7.2 First aid kits shall be equivalent to the 16 unit first aid kit recommended by the American Red Cross, and provided in a ratio of one per 50 persons (campers and staff). Appendix B is a list of materials that makes up a basic 16 unit first aid kit.

**History**
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##### **16 Del. Admin. Code § 4467-11.0** Swimming And Diving Areas {#sec-4467-11.0 omnilex-key=us-de-regs-official--title-16--4467-11.0}

11.1 Management of Swimming and Diving Areas. All swimming, diving areas and bathing places at recreational camps shall be operated and maintained in accordance with the Division of Public Health regulations pertaining to swimming pools and bathing places.

**History**
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##### **16 Del. Admin. Code § 4467-12.0** Water Supply {#sec-4467-12.0 omnilex-key=us-de-regs-official--title-16--4467-12.0}

12.1 The water supply shall be adequate in quantity and shall be obtained from an approved public water supply system when available and in other instances, shall be obtained from a source not considered dangerous or potentially dangerous as determined by a sanitary survey made by an agent of the Division of Public Health, and by bacteriological and chemical examination of the water. Bacteriological and chemical samples will be collected in accordance with schedules prescribed in the State of Delaware Regulations Governing Drinking Water Standards.

12.2 If the water requires treatment in any way, plans and specifications for any such existing or proposed treatment shall be submitted for approval to the Division of Public Health.

**History**
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##### **16 Del. Admin. Code § 4467-13.0** Solid Wastes {#sec-4467-13.0 omnilex-key=us-de-regs-official--title-16--4467-13.0}

13.1 Storage

13.1.1 All garbage and refuse containing food waste shall, prior to disposal, be kept in leak-proof, nonabsorbent, rust and corrosion resistant containers of adequate number, which shall be covered with tight-fitting lids, when filled or stored or not in continuous use, but another manner of storage may be used if approved by the Division of Public Health.

13.1.2 All other refuse shall be stored in containers or areas of sufficient numbers and in a manner so as to prevent arthropod, or rodent problems and other nuisances.

13.2 Disposal. The collection of all garbage and refuse shall be conducted in a sanitary manner to prevent spillage or a nuisance. Garbage shall be removed from the camp preferably daily, but at least every other day.

**History**
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##### **16 Del. Admin. Code § 4467-14.0** Sewage And Liquid Waste Disposal {#sec-4467-14.0 omnilex-key=us-de-regs-official--title-16--4467-14.0}

14.1 Disposal. The sewage and waste water from all recreational camps shall be disposed of in a manner approved by the Division of Public Health and/or the Department of Natural Resources and Environmental Control.

14.2 Sewer Connections. Each independent recreational camp site shall be equipped with provisions for making a watertight connection between the independent camping vehicle drain and the sewer. Each individual sewer connection shall be so constructed that it may be closed when not connected to an independent camping vehicle, and when not in use shall be capped so as to prevent the escape of any odors and the entrance of vermin. Such connections and installations shall comply with all applicable plumbing codes, and shall be equipped with a clean out plug.

**History**
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##### **16 Del. Admin. Code § 4467-15.0** Sanitary Facilities {#sec-4467-15.0 omnilex-key=us-de-regs-official--title-16--4467-15.0}

15.1 Toilet Facilities and Urinals

15.1.1 Toilet facilities and urinals shall be provided in each recreational camp. The minimum number of facilities shall be provided as specified in the following tables:

Table 1. Hostels, Travel Trailer (Dependent Trailer) And Residential Camps – Except Day Camps*

Drinking

# of Males# of Fixtures

# of persons/# of fixtures

1 per 8

1 fixture for each 75 persons

1-12

All new construction must meet the following requirements of the State Plumbing Code:

shall not be substituted for more than 50% of the required water closets.

Flush urinals or urinals specifically designed for females may be substituted for not more than one-half the required number of toilet facilities.

Table 2. Day Camps*

All new construction must meet the following requirements of the State Plumbing Code:

1 per 100

15.1.2 Primitive or Output Camps and Travel Camps situations which involve overnight excursions shall supply potable toilets or slit latrines in a ratio of at least one foot of length for each ten individuals served.

15.1.3 Sleeping areas within a camp shall not be at a greater distance than 200 feet from toilets and urinals.

15.1.4 Each toilet room shall have the following:

15.1.4.1 Doors that are self-closing;

15.1.4.2 Adequate ventilation to the outside air;

15.1.4.3 Toilet tissue;

15.1.4.4 Covered receptacles for women.

15.2 Operation and Maintenance Requirements for Toilet Facilities and Urinals

15.2.1 Water-flushed toilets, chemical toilets or latrines and urinals shall be of a sanitary design and maintained in a clean and sanitary condition.

Table 3. Travel Trailers (Self-contained)

15.3 Handwashing and Bathing Facilities

15.3.1 Hostels, Dependent Travel Trailer and Residential Camps shall provide handwashing and bathing facilities and shall meet the requirements of Table 1.

15.3.2 Day Camps shall not be required to provide bathing facilities, except when such camps utilize a bathing beach, in which case at least one operating showerhead shall be made available. Handwashing facilities shall be provided as stated in Table 2.

15.3.3 Primitive or Outpost Camps, Travel Camps, Troop Camps and Self-Contained Travel Trailer Camps shall not be required to adhere to the handwashing or bathing requirements outlined in Table 1.

15.3.4 Handwashing facilities shall be supplied with hot and cold water under pressure and shall be maintained in a clean and sanitary condition. They shall also meet the standards of the State Plumbing Code. Handwashing facilities shall be provided adjacent to toilet facilities and urinals; and

15.3.5 Shower stalls, bathtub areas and dressing compartments shall be maintained in a clean and sanitary condition. Showers or bathtubs, when provided, shall be in the living areas, or in a centrally located structure, have tempered water and meet the standards of the State Plumbing Code; and

15.4 Drinking Facilities

15.4.1 In all Residential and Day Camps, at least one drinking fountain or facility shall be provided and centrally located.

15.4.2 No common drinking utensils shall be provided or used.

**History**
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##### **16 Del. Admin. Code § 4467-16.0** Farm And Domestic Animals {#sec-4467-16.0 omnilex-key=us-de-regs-official--title-16--4467-16.0}

16.1 Pets and Other Small Animals

16.1.1 The camp premises shall be free of unvaccinated (rabies) dogs or other mammals, which may cause injury or disease to campers.

16.1.2 Horses, dogs or other domestic animals or pets shall not be permitted at swimming, diving or food service areas.

16.1.3 The camp operator shall promptly report to the Division of Public Health any animal bites inflicted upon any individual in the camp area.

16.2 Stable Sanitation

16.2.1 Horses or other farm animals shall not be permanently quartered within 500 feet of living quarters, kitchens, or mess halls.

16.2.2 A temporary shelter, corral, tie-rail or hitching post shall not be located within 200 feet of dining hall, kitchen, or other place where food is prepared, cooked or served.

16.2.3 The stable area shall be provided with toilet facilities for campers, employees and visitors in the event toilet facilities are not conveniently located nearby.

16.2.4 Manure shall not be allowed to remain for more than 24 hours as such locations as temporary shelters, corrals, tie-rails, or hitching posts.

16.2.5 Manure from permanent and shelter quarters shall be removed twice weekly. Interim storage shall be in fly-tight enclosures or an area isolated from camp activity.

16.2.6 Adequate measures shall be taken at all times to keep fly, mosquito, and rodent populations to a minimum.

**History**
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##### **16 Del. Admin. Code § 4467-17.0** Food Safety {#sec-4467-17.0 omnilex-key=us-de-regs-official--title-16--4467-17.0}

17.1 Special Provisions – Youth Camps Excluding Travel Trailer Camps

17.1.1 When campers are allowed to bring food from home for consumption at a camp, facilities shall be provided to insure that spoilage does not occur.

17.1.2 All food taken with the youth camp, or purchased or prepared en route by campers and/or staff, shall be appropriate to the length and type of trip, taking into consideration the lack of refrigeration and problems of sanitation that may be encountered.

17.1.3 Hostels, residential, day camps and travel trailer camps, or any camp where the camp is responsible for the preparation and/or serving of food, shall meet the requirements of the Division of Public Health Regulations Governing Public Eating Places.

**History**
- *Camp Operator Date Inspected by*

##### **16 Del. Admin. Code § 4467-18.0** Transportation {#sec-4467-18.0 omnilex-key=us-de-regs-official--title-16--4467-18.0}

18.1 Responsibility for Campers Being Transported. When a camp provides transportation for a camper, it shall also provide adult supervision between the pickup site, camp, or delivery site.

18.2 Responsibilities in Transit

18.2.1 When two or more vehicles are traveling to the same distant point, there shall be a prearranged method of communication with each other.

18.2.2 Only that number of children or adults for whom there is seating space shall be transported in a vehicle. The maximum capacity of the vehicle shall be clearly indicated thereon. Adequate space for luggage and other equipment shall also be provided.

18.2.3 Standing while in transit and projection of head or limbs outside the vehicle is prohibited.

18.2.4 In addition to the driver, there shall be at all times, at least one adult or counselor in a vehicle on a public thoroughfare when nine or more campers are being transported where the driver and the campers are not physically separated. When physically separated, an adult or counselor must ride in the compartment with the campers.

18.3 Responsibility for Drivers and Vehicles. All camp vehicles shall be equipped with a first aid kit, fire extinguisher, flares, and reflectors.

**History**
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##### **16 Del. Admin. Code § 4467-19.0** Compliance Procedures {#sec-4467-19.0 omnilex-key=us-de-regs-official--title-16--4467-19.0}

19.1 General

19.1.1 Enforcement. It shall be the duty of the State Health Officer, the Deputy State Health Officers, or any officially designated representative to enforce the provisions of this Regulation.

19.1.2 The Division of Public Health, or its designated authority, for just reasons of non-compliance with the requirements of these Regulations, may refuse to issue a permit, may deny the reissuance of a permit, or may suspend a permit. In all cases, the applicant for a permit, or the holder of a permit shall be granted due process in the appeal of action by the Regulatory Authority.

19.2 New and Existing Facilities. The owner/operator of every recreational camp operation shall comply with the requirement of Section 20.0 of these Regulations. If a recreation camp does not have a permit, the Regulatory Authority must notify the Deputy State Health Officer. The Deputy State Health Officer will send a letter to the owner/operator of the recreational camp operations if the owner/operator fails to apply for a permit. Action will be taken as described in Section 20.14 of these Regulations.

19.3 Change of Ownership, Management Firm or Lessee

19.3.1 In the event a recreational camp changes ownership, management firm or lessee, it is the responsibility of the new owner to notify the Regulatory Authority of such a change, and to provide the Regulatory Authority with the name(s) and address(es) of the new owners, managers, operators as an update to the permit application. The notice of the change shall be forwarded to the Deputy State Health Officer in the county in which the recreational camp is located.

19.3.2 If any upgrading of the physical structure of the transferred facility is required based on previous inspection reports of the Regulatory Authority, the new ownership will be held responsible for the needed renovations. Compliance with these Regulations shall be completed prior to the start of business unless the new ownership is either granted a variance in accordance with Section 20.15, or is granted a provisional permit in accordance with Section 7.2.2 of these Regulations. Upon compliance with these Regulations, an annual permit shall be issued to the operator as described in Section 7.2.1.

**History**
- *Camp Operator Date Inspected by*

##### **16 Del. Admin. Code § 4467-20.0** Inspections {#sec-4467-20.0 omnilex-key=us-de-regs-official--title-16--4467-20.0}

20.1 Inspection Frequency. An inspection of a recreational operation shall be performed before a permit is issued and at least once during the operational season by the staff of the Division of Public Health, State of Delaware. Additional inspections of camp operations shall be performed as often as necessary for the enforcement of these Regulations.

20.2 Access. Representatives of the Regulatory Authority, after proper identification, shall be permitted to enter any recreational camp operation at any reasonable time, for the purpose of making inspections to determine compliance with these Regulations. These inspections may include any room or area associated with the camp operation. The Deputy State Health Officer may, after providing an opportunity for a hearing, suspend for a period not to exceed 30 days, the permit to operate a recreational camp operation for refusing access to representatives of the Regulatory Authority.

20.3 Inspection Report Form. The form as modified by these Regulations in Appendix C shall be used to record inspections of the recreational camp as specified in Section 48-13.204 below. The post-construction inspection report form, which appears as Appendix D in these Regulations, shall be used to record the post-construction inspections of a camp. A co-signed copy of the completed inspection report form shall be furnished to the person in charge of the recreational camp operation at the conclusion of the inspection. Inspection remarks on the completed inspection form shall refer to the item(s) violated, give the time period for correcting the violation(s), and shall state the corrections to be made. The inspection report form shall summarize the requirements of the Regulations. It shall also state that, “Failure to comply with any time limits for corrections in this notice may result in cessation of your recreational camp operation.” The completed inspection report form is a public document that shall be made available for public disclosure to any person who requests it, in accordance with the Freedom of Information Act.

20.4 Report of Inspections

20.4.1 Regular Inspections. Regular inspections are performed on a routine basis in permitted facilities. These inspections shall address all items on the inspection report form. Items in violation shall be recorded by item number.

20.4.2 Follow-up Inspections. Follow-up inspections shall be performed when one or more 4 or 5-point weighted items are in violation. The follow-up inspection shall address only the 4 or 5-point weighted items or any other violations the Environmental Health Specialist deems as being merited. Follow-up inspections may also be performed after complaint and investigation inspections, or after conferences and hearings.

20.4.3 Complaint Inspections. Complaint inspections are performed in response to formal or informal complaints against permitted facilities. A complete inspection may be performed by the Regulatory Authority in the interest of the public’s health.

20.4.4 Investigation Inspections. Investigation inspections are performed on permitted or non-permitted recreational camps for determining compliance with these Regulations.

20.4.5 Other Inspections. These inspections include post-construction, pre-operational, and other inspections not included above.

20.5 Epidemiology. When the Regulatory Authority has reasonable cause to suspect possible disease transmission by a recreational camp operation or employee thereof, it may conduct an epidemiological investigation. This can indicate morbidity histories, suspected employees, or make any other investigations as indicated, and shall take appropriate action deemed necessary and feasible by the Deputy State Health Officer or the State Epidemiologist to protect the health of the public and employees of the camp operation.

20.6 Repeat Violations

20.6.1 Correction of Violations

20.6.1.1 Critical Items (4 or 5-point weighted items).

20.6.1.1.1 The establishment shall initiate corrective action on all identified 4 and 5-point weighted violations as soon as possible, but in any event, within 48 hours.

20.6.1.1.2 Follow-up inspection shall be conducted at reasonable time intervals to assure correction.

20.6.1.2 Non-critical Items (2-point weighted items)

20.6.1.2.1 All 2-point weighted items shall be corrected as soon as possible, but in any event, by the time of the next regular inspection

20.6.1.2.2 In the case of temporary recreational camp, all violations shall be corrected within 24 hours. If violations are not corrected within 24 hours, the Deputy State Health Officer, or his designee, in the county in which the temporary recreational camp operates, shall suspend the operating permit. The establishment shall immediately cease recreational camp operations until authorized to resume by the Regulatory Authority.

20.6.1.2.3 If a follow-up inspection indicates non-compliance or general insanitary conditions are found to exist in a recreational camp, a conference shall be scheduled by the Regulatory Authority. However, if the Regulatory Authority determines that conditions warrant, an administrative hearing shall be scheduled.

20.7 Conference

20.7.1 The conference shall be scheduled by the Supervising Sanitarian within five working days after the inspection, or as soon as possible thereafter. Notification of a conference shall be made by hand-delivered letter or certified letter to the person in charge of the recreational camp.

20.7.2 A report documenting the results of the conference shall be submitted in writing to the owner/operator by the Supervising Environmental Health Specialist immediately following the conference.

20.8 Procedure for Administrative Action. If the Deputy State Health Officer determines that a condition(s) exists in a recreational camp operation which represents a threat to life or a serious risk of damage to health, safety and welfare of the public, or if serious violations, repeat violations, or general insanitary conditions are found to exist, administrative action is required.

20.9 Imminent Health Hazards

20.9.1 Suspension of Permit. If some condition is determined to exist in the recreational camp which presents an imminent health hazard to the public, the Deputy State Health Officer, or his designee in the county in which the recreational camp operates, may suspend the operating permit of the recreational camp without a hearing or written notice for a period not to exceed ten (10) days.

20.9.1.1 Such an imminent health hazard shall include, but is not limited to, any one of the following:

20.9.1.1.1 A lack of equipment capable of maintaining the product temperature of all potentially hazardous foods as required in Section 18.3 of these Regulations; or

20.9.1.1.2 An ongoing outbreak of an infectious, pathogenic or toxic agent capable of being transmitted; or

20.9.1.1.3 The absence of potable water, supplied under pressure, in a quantity capable of meeting the needs of the facility; or

20.9.1.1.4 A backup of sewage into the facility or into equipment containing food or utensils; or

20.9.1.1.5 An infestation of vermin to the extend that food and food-contact surfaces cannot be protected from contamination; or

20.9.1.1.6 The absence of adequate toilet facilities.

20.9.1.2 The suspension shall be effective upon receipt of written notice to the person in charge of the recreational camp. A suspension statement recorded on the inspection report by the inspecting Regulatory Representative and acknowledged by the signature of the person in charge constitutes a written notice. Service of a written notice of suspension by the Deputy State Health Officer stating the reason(s) for suspension shall be made as soon as possible, either by certified mail or hand-delivered to the person in charge of the recreational camp. The person in charge shall be requested to yield the permit to the representative of the Regulatory Authority.

20.9.2 Automatic Reinstatement of Permit. In the event of a suspension of a permit without a hearing, the permit shall be reinstated upon expiration of the suspension. In no event shall the permit be suspended for a period longer than ten (10) days without a hearing.

20.9.3 Reinstatement of Permit by Letter. If an inspection by a representative of the Division of Public Health shows the imminent health hazard(s) to no longer exist in the recreational camp, then the permit shall be reinstated by the Deputy State Health Officer or his designee in the county in which the recreational camp operates. Service of a written notice of reinstatement shall be made as soon as possible, either by certified mail or by hand-delivery to the person in charge of the recreational camp. The permit shall be returned to the person in charge.

20.9.4 Reinstatement of Permit by Hearing

20.9.4.1 The owner/operator of the recreational camp may request in writing, a hearing before the Deputy State Health Officer at any time during the period of suspension for the purpose of demonstrating that the imminent health hazard(s) no longer exist(s).

20.9.4.2 The Deputy State Health Officer must schedule a meeting within the 10-day suspension period or the suspension automatically terminates at the end of the 10-day period. The Deputy State Health Officer shall issue a written notice of the hearing to the owner/operator stating the reason for the suspension, the time, date and place of the hearing. The notice shall be hand-delivered to the person in charge at the recreational camp. The recreational camp shall remain closed pending the outcome of the hearing.

20.9.4.3 If the Deputy State Health Officer determines, after a hearing, that the condition(s) which presented an imminent health hazard no longer exist(s), the suspension of the permit of the camp shall end immediately. If, however, the Deputy State Health Officer determines that the conditions still exist, he may order that the suspension be extended indefinitely, until such time that the owner/operator of the camp demonstrates that the condition(s) that present(s) an imminent health hazard no longer exist(s).

20.9.5 Extension of Suspension of Permit by Hearing. If the Deputy State Health Officer has reason to believe that the imminent health hazard(s) will continue to exist after the period of suspension by written notice, he may schedule a hearing to determine whether further suspension is required by notifying the owner/operator in writing. The Deputy State Health Officer may decide to request the Division of Public Health to revoke the permit.

20.9.6 Documentation of Hearings. A record of all proceedings shall be made in accordance with Section 20.13 of these Regulations.

20.10 Division of Public Health Action. If the suspension is extended by the Deputy State Health Officer, the owner/operator of the recreational camp may appeal the extension of the suspension of the permit to the Division of Public Health for reconsideration. However, appeal of the decision shall not stay the suspension of the permit. In order to appeal for reconsideration by the Division of Public Health, a written notice of appeal must be received by the Division of Public Health within ten (10) days after the suspension is announced. The notice of appeal may be sent via certified mail or hand-delivered to the offices of the Division of Public Health, Dover, Delaware. If a notice of appeal is timely filed, the Division of Public Health shall inform the owner/operator of the recreational camp in writing of the time, date and place of the hearing and the reason for the hearing. Delivery of such notice may be made via certified mail or hand-delivered to the person in charge of the recreational camp.

20.11 Administrative Hearings

20.11.1 Whenever the compliance terms of a conference, held in accordance with Section 20.7 of these Regulations, have not been met or whenever conditions in a camp warrant, the Deputy State Health Officer shall schedule an administrative hearing. The purpose of the hearing shall be to consider suspension, or recommend revocation of a permit. The Deputy State Health Officer shall not suspend nor recommend revocation of a permit of a recreational camp for serious or repeated violations, which do not present an imminent health hazard, without having first held a hearing to determine whether the permit should be suspended or revoked.

20.11.2 The holder of the permit, or the person in charge of the recreational camp must be informed at least ten (10) days prior to the hearing of the date, time and place of the hearing and the specific charges against the recreational camp. The notification of the hearing shall be sent by certified mail or by hand-delivery. The Deputy State Health Officer, after providing the opportunity for a hearing, may suspend for a period not to exceed 30 days, or may recommend revocation of a permit to operate a recreational camp for serious or repeated violations of any of the requirements of these Regulations.

20.11.3 If, after holding a hearing, the Deputy State Health Officer renders a decision to suspend, or recommends revocation of the permit, the decision shall not be effective until ten (10) days after the decision is announced in writing to the defendant. A recommendation to revoke a permit must be forwarded to the Division of Public Health in writing.

20.12 Right of Appeal to the Division of Public Health. The owner/operator of the recreational camp may appeal to the Division of Public Health for reconsideration of the decision of the Deputy State Health Officer. In order to appeal for reconsideration, written notice of appeal must be received by the Division of Public Health within ten (10) days after the decision of the Deputy State Health Officer is announced. The notice of appeal may be sent via certified mail or hand-delivered to the Division of Public Health, Dover, Delaware. If a notice of appeal is timely filed, the decision of the Deputy State Health Officer in regard to suspension or revocation of the permit of a camp for critical or repeat violations, will be stayed until that decision is confirmed by the Division of Public Health. If the notice of appeal is timely filed, the Division of Public Health shall hold a hearing within 30 days of the filing of the notice of appeal with the Division.

20.13 Records of Administrative Proceedings. The hearings provided for in these Regulations shall be conducted by the regulatory authority at a time and place designated by it. Written minutes shall be made of all hearing proceedings and shall become documents of record. A written report of the hearing decision shall be furnished to the holder of the permit by the Deputy State Health Officer within 10 days following the hearing.

20.14 Refusing to Apply for a Permit. If the owner/operator of a recreational camp operation refuses to apply for a permit or the establishment does not comply with the requirements of these Regulations, then the Supervising Environmental Health Specialist shall refer the case, to the Deputy State Health Officer.

20.15 Variance

20.15.1 The Division of Public Health may, from time to time, grant written permission to individual employers or providers of recreational camp operations to vary from particular provisions set forth in this Part when the extent of the variation is clearly specified, and it is demonstrated to their satisfaction that:

20.15.1.1 Such variation is necessary to obtain a beneficial use of an existing facility;

20.15.1.2 The variation is necessary to prevent a practical difficulty or unnecessary hardship; and

20.15.1.3 Appropriate alternative measures have been taken to protect the health and safety and assure that the purposes of the provisions from which the variation is sought will be observed.

20.15.2 Written applications for such variations shall be filed with the Director, Division of Public Health. No such variation shall be effective until granted by the Division of Public Health.

20.16 Remedies

20.16.1 Penalties. Any person (or responsible officer of that person) who violates a provision of this Regulation, and any person (or responsible officer of that person) who is the holder of a permit or who otherwise operates a recreational camp operation that does not comply with the requirements of these Regulations shall be subject to the provisions of 16 Del.C. §107.

APPENDIX A

Notifiable Disease

Acquired Immune Deficiency Syndrome (T)

Amebiasis

Anthrax (T)

Botulism (T)

Brucellosis

Campylobacteriosis

Chancroid

Cholera (T)

Diphtheria (T)

Encephalitis

Foodborne Disease Outbreaks (T)

Giardiasis

Gonococcal Infections

Granuloma Inguinale

Hansen's Disease (Leprosy)

Hepatitis (viral-all types)

Histoplasmosis

Influenza

Lead Poisoning

Legionnaires Disease

Leptospirosis

Lymphogranuloma Venereum

Malaria

Measles (T)

Meningitis (bacterial)

Meningitis (aseptic)

Meningococcal Disease (other)

Mumps

Pertussis

Plague (T)

Poliomyelitis (T)

Psittacosis

Rabies (man, animal) (T)

Reye's Syndrome

Rocky Mountain Spotted Fever

Rubella

Rubella, Congenital Syndrome

Salmonellosis

Shigellosis

Smallpox (T)

Syphilis

Tetanus

Toxic Shock Syndrome

Trichinosis

Tuberculosis

Tularemia

Typhoid Fever (T)

Typhus Fever

Vaccine Adverse Reactions

Waterborne Disease Outbreaks (T)

Yellow Fever (T)

(T)'s Notified by telephone call

APPENDIX B

First Aid Kit

First aid kits can be made from old shoeboxes, fishing tackle boxes or purchases commercially. The following materials make up the basic contents for a l6 unit first aid kit:

2 packages 1” adhesive compress

2 packages 2” bandage compress

1 package 3” bandage compress

1 package 4” bandage compress

1 package 3” x 3” plain gauze pads

1 package 2” gauze roller bandage

2 packages plain absorbent gauze – ½ sq. yd.

2 packages plain absorbent gauze - 24" x 72"

3 packages triangular bandages (40” – 1 tourniquet)

Scissors

Tweezers

Eye dressing packet

Alcohol

Adhesive tape

Antiseptic spray – small container

Tongue depressors

Telephone number of doctor, hospital or place where medical care can be obtained should be written on top of the box.

Tape a quarter on inside of box for telephone call if pay telephone has to be used.

Training in first aid is available through the local units of the American National Red Cross.

APPENDIX C

STATE OF DELAWARE

DEPARTMENT OF HEALTH AND SOCIAL SERVICES

RECREATIONAL CAMP INSPECTION REPORT

N/A = Not Applicable

N/O = Not Observed

Based on an inspection this day, the items circled below identify the violation of the facility. Failure to comply with any time limits for corrections in this notice may result in cessation of your recreation camp operations.

Name of Camp Address Phone # Camp Capacity

Name of Operator Address Zip Code

Item

Wt.

Item

Wt.

Item

48-2.0 General Sanitation

48-2.101 Site Drained

2

*48-2.107 Day Camp Shelter

sufficient for inclement

weather

4

*48-.5 Swimming and

Diving Areas Meets the

Requirements of the State

Board of Health. A

separate inspection sheet

is required for this area

All natural hazards, pits,

abandoned excavations

shall be fenced

2

*48-2.108 Tent camp/travel

trailer - 25 ft x 25 ft.

for each space, 15 ft. apart

4

48-2.102 Shelter -

Good repair

2

48-3.0 General Supervision

48-3.101 Ration of Coun-

selors to campers - resi-

dential, day camps,

primitive, travel camps

2

*48-6.0 Water Supply -

Adequate, approved

Source

Floors cleanable, good

Repair

2

*48-2.103 Shelter-Resi-

dential - 50 square feet/

person, 2 feet between

bunks

5

48-7.0 SolidWaste -

Storage, disposal

48-3.102 Camp Director -

Qualified

2

48-8.0 Sewage/Liquid

Waste Disposal

*Approved disposal

Separate space for

clothing/personal

belongings

4

48-3.103-110 Supervision

of activities - Adequate

2

*sewer connections

48-4.0 General Health

* 48-4.102 Health records

available

5

*48-9.0 Sanitary Facili-

Ties - Toilets, urinals,

lavatories, showers,

drinking facilities -

adequate in number

Non-absorbent bedding,

cleaned/sanitized after

use

4

*4--4.104 Communicable

diseases reported

5

Sleeping quarters -

Min. 7 ft. ceiling

4

*48-4.105 Health staff

5

Sanitary design, clean

48-2.104 Lighting -

fixtures and outlet

2

*48-4.106 Medication

5

48-10.0 Farm/Domestic

Animals - Restricted,

stable sanitation

48-4.107 First aid supplies

2

48-2.105 Rodent/Insect

Control - Windows

Screened

2

*48-11.0 Food Service -

Meets requirements of

State Board of Health - a

separate inspection sheet

required for this area

Doors self-closing, open

outward

2

48-2.106 Weeds controlled

in central camp area.

2

48-12.0 Transportation -

supervision, speed limits

posted

*Items identified as critical

Remarks:

Follow Up Inspection Rating Score: ®®®

Yes ® No ®

Received by: Date Inspected by:

APPENDIX D

STATE OF DELAWARE

DEPARTMENT OF HEALTH AND SOCIAL SERVICES

Recreational Camp

Post-Construction Inspection Report

N/O Not Observed

Based on an inspection this day, the items circled below identify the violations of the facility which must be corrected before a permit may be issued to operate the Recreational Camp.

Name of Camp Address Phone # Camp Capacity

Name of Operator Address Zip Code

Section

Item

Section

Item

48-2.101

Site Well drained

48-2.107

Day camp shelters - Provision for

48-2.102

Shelter in good repair

inclement weather

Floors - cleanable construction,

48-2.108

Tent camp/travel trailer - 25 x

good repair

25 ft. space, 15 ft. apart

48-2.103

Shelter - Residential Camps/Hostels

48-4.107

First aid supplies - Available in

50 sq. ft. of floor space/person

food service and program areas

2 ft. between each bunk

48-5.0

Swimming/diving areas - Meets

Bed arrangement

regulation

Separate space for clothing and

48-6.0

Water supply - Adequate

personal belongings

48-8.1

Sewage/liquid waste disposal -

Bedding - non-absorbent covers

Facilities approved

cleaned and sanitized after each

48-8.2

Sewer connections - Watertight

camper

48-9.1

Toilet facilities, lavatories,

Minimum ceiling height

showers and drinking fountains -

48-2.104

Lighting - Fixtures and outlet

Adequate

48-2.105

Rodent/insect control - Doors

48-10.0

Farm and domestic animals - No

self-closing, open outward

animals permanently quartered

exterior openings screened

within 500 ft. of living quarters,

48-2.106

Weed control - Weeds under control

kitchens or mess halls

in central camp area

48-11.0

Food service - Food protected,

meets requirements of the

Division of Public Health

Remarks

**History**
- *Camp Operator Date Inspected by*

#### **4469** Personal Assistance Services Agencies (Transferred)

##### **16 Del. Admin. Code § 4469** Personal Assistance Services Agencies (Transferred) {#sec-4469 omnilex-key=us-de-regs-official--title-16--4469}

Transferred to Division of Health Care Quality 3345 Personal Assistance Services Agencies, effective June 11, 2020.

**History**
- *11 DE Reg. 196 (08/01/07)*
- *19 DE Reg. 852 (03/01/16)*
- *23 DE Reg. 1033 (06/01/20)*

#### **4470** State of Delaware Medical Marijuana Code

##### **16 Del. Admin. Code § 4470** State of Delaware Medical Marijuana Code {#sec-4470 omnilex-key=us-de-regs-official--title-16--4470}

Preamble

The Secretary of Delaware Health and Social Services adopts these regulations in response to the authority vested in the Secretary by 16 Del.C. Ch. 49A, The Delaware Medical Marijuana Act. These regulations establish the standards for the procedures for issuing a certificate of registration to qualified patients and designated caregivers. These regulations provide a system of permitting and inspection, as well as governing confidentiality, payments of fees, and enforcement of these rules.

Purpose

These regulations shall be liberally construed and applied to promote their underlying purpose of protecting the public’s health.

**History**
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *15 DE Reg. 1728 (06/01/12)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *15 DE Reg. 1728 (06/01/12)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*

##### **16 Del. Admin. Code § 4470-1.0** State of Delaware Medical Marijuana Code {#sec-4470-1.0 omnilex-key=us-de-regs-official--title-16--4470-1.0}

These regulations shall hereby be known as the “State of Delaware Medical Marijuana Code.”

**History**
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *15 DE Reg. 1728 (06/01/12)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *15 DE Reg. 1728 (06/01/12)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*

##### **16 Del. Admin. Code § 4470-2.0** Definitions {#sec-4470-2.0 omnilex-key=us-de-regs-official--title-16--4470-2.0}

The following words and terms, when used in these regulations, should have the following meaning, unless the context clearly indicates otherwise:

“Act” means the Delaware Marijuana Act, 16 Del.C. §§4901A et seq.

“Applicant” means any person applying to participate in the Delaware Medical Marijuana Program, hereinafter MMP.

"Background check" means any person required to obtain a background check under this chapter shall submit fingerprints and other necessary information to the State Bureau of Identification in order to obtain a report of the person's entire criminal history record from the State Bureau of Identification or a statement that the State Bureau of Identification Central Repository contains no such information relating to that person. The report will include the person's entire federal criminal history record from the Federal Bureau of Investigation pursuant to Federal Bureau of Investigation appropriation of Title II of Public Law 92-544 (28 U.S.C. § 534) or a statement that the Federal Bureau of Investigation's records contain no such information relating to that person. A person required to obtain a background check under this chapter is responsible for any costs associated with obtaining the background check.

"Batch" A batch is a collection of plants of the same strain and genetics, grown in the same room at the same time. The maximum batch size is five (5) pounds or 2268 grams.

"Bona fide physician-patient relationship" means a treatment or counseling relationship between a physician and patient in which all the following are present:

(1) The physician has reviewed the patient's relevant medical records and completed a full assessment of the patient's medical history and current medical condition, including a relevant, in-person, medical evaluation of the patient.

(2) The physician has created and maintained records of the patient's condition in accord with medically accepted standards.

(3) The patient is under the physician's continued care for primary medical care or the debilitating condition that qualifies the patient for the Medical Marijuana Program.

(4) The physician has a reasonable expectation that he or she will provide follow-up care to the patient to monitor the efficacy of the use of medical marijuana as a treatment of the patient's debilitating medical condition.

(5) The relationship is not for the sole purpose of certifying for medical marijuana.

“Cannabidiol” or “CBD” is a cannabinoid found in cannabis with mild psychoactive properties that does not induce a euphoric high.

"Cannabidiol-Rich medical marijuana" or "CBD-Rich" means a marijuana strain or product formulization that has elevated levels of cannabidiol ("CBD") and contains the profile of CBD and tetrahydrocannabinol ("THC") concentrations approved by the Department, based upon the recommendation of the Medical Marijuana Act Oversight Committee.

“Cardholder” means a registered patient or a registered designated caregiver who has been issued and possesses a valid registry identification card.

“Compassion center agent” means a principal officer, board member, employee, or agent of a registered compassion center who is 21 years of age or older and has not been convicted of an excluded felony offense, and has not been convicted of a drug misdemeanor within five years.

“Compassionate use card” means a card issued by the Department for conditions not covered in the Act or regulations. The compassionate use card has additional requirements for approval.

“Concentrate” means any product created when marijuana flowers are refined into something purer and more potent. This umbrella term includes any type of hash (water hash, pressed hash), dry sieve (kief), as well as hash oils (CO2 oil, shatter, wax, and rosin) and indicates that these products are a concentrated form of cannabis, carrying a higher potency.

“Consumer” means a person who is a patient in the Medical Marijuana Program, takes possession of marijuana, and is not functioning in the capacity of an operator of a marijuana business.

“Debilitating medical condition” means one or more of the following:

(a) Terminal illness, cancer, positive status for human immunodeficiency virus (HIV), acquired immune deficiency syndrome (AIDS), decompensated cirrhosis, amyotrophic lateral sclerosis (ALS or Lou Gehrig’s Disease), post-traumatic stress disorder (PTSD), intractable epilepsy, autism with self-injurious or aggressive behavior, seizure disorder, glaucoma, chronic debilitating migraines, new daily persistent headache, and agitation of Alzheimer’s disease or the treatment of these conditions;

(b) A chronic or debilitating disease medical condition or its treatment that produces one or more of the following: cachexia or wasting syndrome; severe, debilitating pain that has not responded to previously prescribed medication or surgical measures for more than three months or for which other treatment options produced serious side effects; intractable nausea; seizures; or severe and persistent muscle spasms, including but not limited to those characteristic of multiple sclerosis;

(c) Pediatric qualifying conditions are limited to any of the following related to a terminal illness: pain, anxiety, or depression; seizure disorder; severe debilitating autism; or a chronic or debilitating disease or medical condition where they have failed treatment involving one or more of the following symptoms: cachexia or wasting syndrome; intractable nausea; severe, painful and persistent muscle spasms; and chronic debilitating migraines and new daily persistent headache that are refractory to conventional treatment and interventions; or

(d) Any other medical condition or its treatment added by the Department, as provided for in 16 Del.C. §4906A and Section 6.0 of this Code; or

(e) Anxiety, which is restricted to CBD-Rich medical marijuana products.

“Delaware Enterprise Consolidated Cannabis Control System” or “DEC3S” is the statewide application which serves as patient registry, point of sale monitor, seed to sale inventory tracker and repository of medical marijuana product test results.

“Department” means the Delaware Department of Health and Social Services.

“Designated caregiver” means a person who:

(a) Is at least 21 years of age unless the person is the parent or legal guardian of a minor who is a qualifying patient;

(b) Has agreed to assist with a patient's medical use of marijuana;

(c) Has not been convicted of an excluded felony offense; and

(d) Assists no more than five qualifying patients with their medical use of marijuana.

“Direct Sales” means sales of marijuana products within the State of Delaware directly to the registered patients without the use of an independent retailer or other intermediary.

“Division” means the Delaware Division of Public Health.

“Employee” or “Agent” refers to an individual having supervisory or management duties, an individual on the payroll, a volunteer, an individual performing work under contractual agreement, or any other individual working in a marijuana business.

“Excluded felony offense” means:

(a) A violent crime defined in 11 Del.C. §4201(c), that was classified as a felony in the jurisdiction where the person was convicted; or

(b) A violation of a state or federal controlled substance law that was classified as a felony in the jurisdiction where the person was convicted, not including:

(1) An offense for which the sentence, including any term of probation, incarceration, or supervised release, was completed 10 or more years earlier; or

(2) An offense that consisted of conduct for which 16 Del.C. Ch. 49A would likely have prevented a conviction, but the conduct either occurred prior to July 1, 2011, or was prosecuted by an authority other than the State of Delaware.

“Food-Contact Surface” means a surface of equipment or a utensil with which food normally comes into contact; or a surface of equipment or a utensil from which food may drain, drip or splash into a food or onto; or a surface normally in contact with food.

“Imminent Health Hazard” means a significant threat or danger to health that is considered to exist when there is evidence sufficient to show that a product, practice, circumstance, or event creates a situation that requires immediate correction or cessation of operation to prevent injury based on the number of potential injuries and the nature, severity, and duration of the anticipated injury.

"Inspection" means a visit by an employee of the Department for the purpose of ensuring compliance with the requirements of these rules.

"Intractable epilepsy" means an epileptic seizure disorder for which standard medical treatment does not prevent or significantly ameliorate recurring, uncontrolled seizures or for which standard medical treatment results in harmful side effects.

“Marijuana” means the same as defined in 16 Del.C. §4701.

“Marijuana Infused Food Products” refers to a non-time/temperature controlled (non-TCS) for safety food as specified in these regulations that is offered for sale directly to consumers and only at a licensed Compassion Center.

“Marijuana Infused Food Establishment” refers to a licensed Compassion Center that has received an endorsement from the Department to make non-time/temperature controlled (non-TCS) marijuana infused food products.

"Medical Marijuana Act Oversight Committee" means the committee established to evaluate and make recommendations regarding the implementation of 16 Del.C. Ch. 49A.

"Medical marijuana oil" means a resinous matrix of cannabinoids obtained from the Cannabis plant by solvent extraction, formed into oil.

"Medical marijuana waste" means unused, surplus, returned, or out of date medical marijuana, recalled medical marijuana, and any plant debris, including dead plants, all unused plant parts, and roots.

“Medical use” means the acquisition, possession, use, delivery, transfer or transportation of marijuana or paraphernalia relating to the administration of marijuana to treat or alleviate a registered patient’s debilitating medical condition or symptoms associated with the registered patient’s debilitating medical condition.

"Pediatric Medical marijuana oil" means:

a. "Cannabidiol oil" which is a processed Cannabis plant extract that contains at least 15% cannabidiol but no more than 7% tetrahydrocannabinol, or a dilution of the resin of the Cannabis plant that contains at least 50 milligrams of cannabidiol per milliliter but not more than 7% tetrahydrocannabinol.

b. "THC-A oil" which is a processed Cannabis plant extract that contains at least 15% tetrahydrocannabinol acid but not more than 7% tetrahydrocannabinol, or a dilution of the resin of the Cannabis plant that contains at least 50 milligrams of tetrahydrocannabinol acid per milliliter but not more than 7% tetrahydrocannabinol.

c. Any change in the oil formulation which is made by the Department based upon the recommendation of the Medical Marijuana Act Oversight Committee.

“Physician” means a properly licensed physician subject to 24 Del.C. Ch. 17, except as otherwise provided in this definition. If the qualifying patient is younger than 18 years of age, the physician must be a pediatric neurologist, pediatric gastroenterologist, pediatric oncologist, pediatric psychiatrist, developmental pediatrician or pediatric palliative care specialist.

“Poisonous and Toxic Materials” means substances that are not intended for ingestion, including cleaners and sanitizers; pesticides; necessary maintenance substances such as non-food grade lubricants; and personal care items such as medicines, first aid supplies, cosmetics and toiletries.

“Post-Traumatic Stress Disorder” means that a patient meets the diagnostic criteria for Post-Traumatic Stress Disorder (PTSD), per DSM-5 or subsequent current edition, including symptoms of intense physical reactions such as tachycardia, shortness of breath, rapid breathing, muscle-tension, and sweating.

“Processing area” refers to the area of the marijuana business where marijuana is prepared, trimmed, packaged or food prep and other food service activities occur.

“Producer” refers to employees of the Marijuana Infused Food Establishment involved with the production of marijuana infused products.

“Qualifying patient” means an individual who meets the qualifications to receive a registry identification card under this chapter.

“Registry identification card” means a document issued by the Department that identifies a person as one of the following:

a. A registered qualifying adult patient.

b. A registered designated caregiver for a qualifying adult patient.

c. A registered designated caregiver for a pediatric patient.

d. A registered adult compassionate use patient.

e. A registered designated caregiver for an adult compassionate use patient.

f. A registered designated caregiver for a pediatric compassionate use patient.

g. A registered CBD-Rich patient.

h. A registered designated caregiver for a CBD-Rich patient.

"Responsible Party" means the parent or legal guardian with responsibility and decision-making capability for a qualifying patient or applicant. The Responsible Party will have primary responsibility for purchase, handling and dispensing of the medical marijuana products for the person under the Responsible Party’s charge.

"Safety Compliance Facility'' means a nonprofit organization permitted to test marijuana produced for medical use for potency and contaminants.

“Sanitization” refers to a heat or chemical treatment on cleaned food contact surfaces that is sufficient to yield a 99.999% reduction of the number of representative disease microorganisms of public health significance.

“Temperature Measuring Device” or “TMD” means a thermometer, thermocouple, thermistor or other device that indicates the temperature of food, air or water.

“Terminal Illness” means any disease, illness or condition sustained by any human being for which there is no reasonable medical expectation of recovery; which, as a medical probability, will result in the death of such human being regardless of the use or discontinuance of medical treatment implemented for the purpose of sustaining life or the life processes; and as a result of which, the human being’s health-care practitioner would not be surprised if death were to occur within 12 months.

“Tetrahydrocannabinol Delta 9” or “THC” is a decarboxylated cannabinoid found in cannabis with strongly psychoactive properties that induces a euphoric high.

“Time/Temperature Control for Safety Food” or “TCS” means a food that requires time/temperature control for safety (TCS) to limit pathogenic microorganism growth or toxin formation.

“Tincture” means a mixture created from a concentrated extract of marijuana.

“Topical” means a mixture or extract of marijuana made into a balm, lotion, ointment or rubbing alcohol solution, that is applied transcutaneously for treatment.

“Usable marijuana” means the dried leaves and flowers of the marijuana plant, and any mixture or preparation of those dried leaves and flowers, including but not limited to tinctures, ointments, and other preparations including medical marijuana oil, but does not include the seeds, stalks, and roots of the plant. It does not include the weight of any non-marijuana ingredients combined with marijuana, such as ingredients added to prepare a topical administration, food, or drink.

“Written certification” means a document dated and signed by a physician, stating that in the physician’s opinion the patient is likely to receive therapeutic or palliative benefit from the medical use of marijuana to treat or alleviate the patient’s debilitating medical condition or symptoms associated with the debilitating medical condition. A written certification shall be made only in the course of a bona fide physician-patient relationship where the qualifying patient is under the physician’s care for the qualifying patient’s primary care or for the qualifying patient’s debilitating condition after the physician has completed an assessment of the qualifying patient’s medical history and current medical condition. The bona fide physician-patient relationship may not be limited to authorization for the patient to use medical marijuana or consultation for that purpose. The written certification shall specify the qualifying patient’s debilitating medical condition.

**History**
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *15 DE Reg. 1728 (06/01/12)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *15 DE Reg. 1728 (06/01/12)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*

##### **16 Del. Admin. Code § 4470-3.0** Qualifying Patient Identification Card Application Requirements {#sec-4470-3.0 omnilex-key=us-de-regs-official--title-16--4470-3.0}

3.1 The Department shall issue a registry identification card to an applicant for the purpose of participating in the medical marijuana program upon the written certification of the applicant’s physician, supporting application documents and a non-refundable application fee with a personal check or a cashier’s check made out to “State of Delaware-MMP”. The following information must be provided in the participant enrollment form submitted to the Department in order for a registry identification card to be obtained and processed.

3.2 An attached original written certification for patient eligibility form shall contain:

3.2.1 The name, address and telephone number of the applicant’s physician;

3.2.2 The physician’s clinical licensure;

3.2.3 The patient applicant’s name and date of birth;

3.2.4 The medical justification for the physician’s certification of the patient’s debilitating medical condition;

3.2.5 The physician’s signature and date;

3.2.6 The name and address of the applicant as they appear on the applicant's government issued ID card, and date of birth of the applicant;

3.2.7 The name, address and date of birth of the applicant’s primary caregiver or caregivers, if any;

3.2.8 A reasonable xerographic copy of the applicant’s Delaware driver’s license or comparable State of Delaware or federal issued photo identification card verifying Delaware residence; State of Delaware issued identification card must be available for inspection/verification;

3.2.9 The length of time the applicant has been under the care of the physician providing the medical provider certification for patient eligibility;

3.2.10 The applicant’s signature and date; and

3.2.11 A signed consent for release of medical information related to the patient’s debilitating medical condition, on a form provided by the medical marijuana program.

3.2.12 A designation of type of card: Adult Patient, Pediatric Patient, Compassionate Use Adult Patient, Compassionate Use Pediatric Patient, or CBD-Rich Adult Patient.

3.3 If the qualifying patient is under the charge of a Responsible Party as defined in these regulations:

3.3.1 The Responsible Party must be identified on the application.

3.3.2 If the qualifying patient is of an age where an ID to meet subsections 3.2.6 and 3.2.8 above has not been issued, the Responsible Party's ID shall be used. If the qualifying patient has a government issued ID, information and IDs for both individuals shall meet subsections 3.2.6 and 3.2.8 above.

3.3.3 If the patient is under the age of 18, the physician must be a pediatric neurologist, pediatric gastroenterologist, pediatric oncologist, pediatric psychiatrist, developmental pediatrician or pediatric palliative care specialist and certify that:

3.3.3.1 The qualifying patient has any of the following related to a terminal illness: pain, anxiety or depression; or

3.3.3.2 The qualifying patient has intractable epilepsy or seizure disorder;

3.3.3.3 The qualifying patient has a chronic or debilitating disease or medical condition where the patient has failed treatment involving one or more of the following symptoms: cachexia or wasting syndrome; intractable nausea; severe, painful and persistent muscle spasms; or chronic debilitating migraines and new daily persistent headache that are refractory to conventional treatment and interventions; or

3.3.3.4 The qualifying patient has severe debilitating autism.

3.3.4 Patients under the age of 18 will have distinctive identifying banner on their patient identification card limiting the patient to marijuana oil purchases only.

3.3.5 Responsible Parties for qualifying patients under the age of 18 will be issued an identification card with the same type of 10-digit alphanumeric identifier provided to the minor in question.

3.4 The Department shall issue a compassionate use card to an eligible individual who submits all of the following:

3.4.1 A signed statement from the patient’s physician that includes statements attesting to all of the following:

3.4.1.1 The patient has a severe and debilitating condition;

3.4.1.2 All current standard care practices and treatments have been exhausted and have been ineffective or the side effects are prohibitive with continued use;

3.4.1.3 The physician will re-evaluate and document the efficacy of medical marijuana treatment;

3.4.1.4 There are grounds supporting the potential for the patient to benefit from using medical marijuana;

3.4.1.5 The treating physician must detail how medical marijuana will be integrated into the patient's comprehensive treatment plan, identifying all wrap-around services including counseling, other medications, or specialty care. The Department will review the comprehensive treatment plan, including the re-evaluation interval.

3.4.1.6 If the patient is an adult, a signed statement from the patient acknowledging the patient’s informed consent to treatment with medical marijuana and that the patient knows that there is limited or no evidence associated with medical marijuana’s effectiveness in treating a condition that is not a debilitating medical condition under this chapter.

3.4.1.6.1 If the patient is under 18 years of age, a signed statement from the patient’s parent or legal guardian acknowledging the patient’s informed consent to treatment with medical marijuana and that the patient’s parent or legal guardian knows that there is limited or no evidence associated with medical marijuana’s effectiveness in treating a condition that is not a debilitating medical condition under this chapter.

3.4.2 The physician certifying a patient for a compassionate use card will re-evaluate the efficacy of medical marijuana treatment at the following intervals:

3.4.2.1 For substance use disorder diagnoses, re-evaluate after 15 days for the first 90 days, and every 30 days thereafter;

3.4.2.2 For mental health disorder diagnoses, re-evaluate every 30 days;

3.4.2.3 For autoimmune disease diagnoses, re-evaluate every 30 days for the first 90 days, and every 90 days thereafter; and

3.4.2.4 For other conditions, re-evaluate every 30 days, unless otherwise indicated or waived by the Department.

3.4.3 The timeframe for reevaluation begins on the date the card is issued.

3.4.4 The physician certifying a patient for a compassionate use card may require the re-evaluation of the patient at shorter intervals than listed if appropriate.

3.4.5 Updated documentation of the re-evaluations for the compassionate use card must be transmitted to the Department by the certifying practice within five business days of the re-evaluation interval to prevent the compassionate use card from entering a suspension status.

3.5 CBD-Rich Medical Marijuana

3.5.1 The Department shall issue a CBD-Rich card to a qualifying patient whose provider has certified that their debilitating medical condition is anxiety.

3.5.2 A patient who qualifies for a CBD-Rich card may only purchase Cannabidiol-Rich medical marijuana products.

3.5.3 Any condition that is authorized under the Medical Marijuana Act for adult patients 18 years and older may be treated with CBD-Rich medical marijuana.

**History**
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *15 DE Reg. 1728 (06/01/12)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *15 DE Reg. 1728 (06/01/12)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*

##### **16 Del. Admin. Code § 4470-4.0** Designated Caregiver Registry Identification Card Application Requirements {#sec-4470-4.0 omnilex-key=us-de-regs-official--title-16--4470-4.0}

4.1 The Department shall issue a registry identification card to a designated caregiver applicant for the purpose of managing the well-being of one to five qualified patients, including themselves if caregiver is a qualified patient, in response to the requirements of this rule upon the completion and approval of the designated caregiver application form, available from the medical marijuana program, and a non-refundable application fee, in the form of a personal check, money order or a cashier’s check made out to “State of Delaware-MMP”. In order for a registry identification card to be obtained and processed, the following information shall be submitted to the medical marijuana program:

4.1.1 Proof that the applicant is at least 21 years of age unless the person is the parent or legal guardian of a minor who is a qualifying patient;

4.1.2 A reasonable xerographic copy of the applicant’s Delaware license or comparable State of Delaware or federal issued photo identification card verifying Delaware residence; State of Delaware issued identification card must be available for inspection/verification.

4.1.3 Written approval by the qualified patient or patients authorizing responsibility for managing the well-being of a qualified patient or patients with respect to the use of marijuana;

4.1.4 The name, address, telephone number, and date of birth of each qualified patient;

4.1.5 The name and address of the applicant as they appear on the applicant's government issued ID card, telephone number of the applicant; and

4.1.6 The applicant’s signature and date.

4.2 Designated caregiver application requirements:

4.2.1 Criminal history screening requirements:

4.2.1.1 All designated caregiver applicants are required to consent to a nationwide and statewide criminal history screening background check every three years. All applicable application fees associated with the nationwide and statewide criminal history screening background check shall be paid by the designated caregiver applicant.

4.2.1.2 Individuals convicted of an excluded felony offense, as described in the definitions Section 2.0, and 16 Del.C. §4902A(7) are prohibited from serving as a designated caregiver. The applicant and qualified patient shall be notified by registered mail of his or her disqualification from being a designated caregiver.

**History**
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *15 DE Reg. 1728 (06/01/12)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *15 DE Reg. 1728 (06/01/12)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*

##### **16 Del. Admin. Code § 4470-5.0** Registry Identification Cards {#sec-4470-5.0 omnilex-key=us-de-regs-official--title-16--4470-5.0}

5.1 Department inquiry:

5.1.1 The Department may verify information on each application and accompanying documentation by the following methods:

5.1.1.1 Contacting each applicant by telephone, mail, or if proof of identity is uncertain, the Department shall require a face-to-face meeting and the production of additional identification materials;

5.1.1.2 Contacting the Delaware Division of Professional Regulation to verify that the physician is licensed to practice medicine in Delaware and is in good standing; and

5.1.1.3 Contacting the physician to obtain further documentation that the applicant’s medical diagnosis and medical condition qualify the applicant for enrollment in the medical use marijuana program.

5.1.2 Upon verification of the information contained in an application submitted in response to this subsection, the Department shall approve or deny an application within 45 calendar days of receipt.

5.2 Department registry identification card: The Department shall issue a registry identification card within 30 calendar days of approving an application. A registry identification card shall contain a 10-digit alphanumeric identification, maintained by the Department, which identifies the qualified patient or designated caregiver. Unless renewed at an earlier date, suspended or revoked, or if the physician stated in the written certification that the qualifying patient would benefit from marijuana until a specified earlier date, a registry identification card shall be valid for a period of one year from the date of issuance and shall expire at midnight on the day indicated on the registry identification card as the expiration date.

5.3 Supplemental requirement:

5.3.1 A registered qualifying patient or registered designated caregiver who possesses a registry identification card shall notify the Department of any of the following within 10 calendar days of the change. An extension shall be granted by the medical marijuana program upon the showing of good cause.

5.3.1.1 A change in cardholder's name or address.

5.3.1.2 Knowledge of a change that would render the patient no longer qualified to participate in the program, such as a cure of the debilitating condition causing the need for Medical Marijuana.

5.3.1.3 Knowledge of a change that renders the patient's physician no longer a qualified "physician" as defined in Section 2.0 of these regulations; and

5.3.1.4 Knowledge of a change that renders the patient's caregiver no longer eligible as defined in these regulations.

5.3.2 Before a registered qualifying patient changes his or her designated caregiver, the qualifying patient must notify the Department in writing.

5.3.3 If a cardholder loses his or her registry identification card, he or she shall notify the Department in writing within 10 days of becoming aware the card has been lost. Upon notification, the Department shall issue a new registry identification card. Unless documentation in the initial application has changed, the qualified patient or designated caregiver shall not be required to submit a new application.

5.3.4 When a cardholder notifies the Department of items listed in subsection 5.3 but remains eligible, the Department shall issue the cardholder a new registry identification card with a new random 10-digit alphanumeric identification number within 10 days of receiving the updated information and the cardholder shall pay a $20 fee. If the person notifying the Department is a registered qualifying patient, the Department shall also issue his or her registered designated caregiver, if any, a new registry identification card within 10 days of receiving the updated information.

5.3.5 If a registered qualifying patient ceases to be a registered qualifying patient or changes his or her registered designated caregiver, the Department shall promptly notify the designated caregiver by legal process server. The registered designated caregiver's protections under this chapter as to that qualifying patient shall expire 15 days after notification by the Department.

5.3.6 A cardholder who fails to make a notification to the Department that is required by subsection 5.3 is subject to a civil infraction, punishable by a penalty of no more than $150.00 and is also subject to the immediate revocation of the registry identification card and all lawful privileges provided under the act.

5.3.7 If the registered qualifying patient's certifying physician notifies the Department in writing that either the registered qualifying patient has ceased to suffer from a debilitating medical condition or that the physician no longer believes the patient would receive therapeutic or palliative benefit from the medical use of marijuana, the card shall become null and void. However, the registered qualifying patient shall have 15 days to dispose of the patient's marijuana.

5.3.8 When a registered qualifying pediatric patient attains 18 years of age, the patient may request a new patient card releasing them from the pediatric restrictions. The new patient ID card will be issued at the card replacement cost $20 and maintain the original expiration date.

5.4 Registry identification card application denial: The DHSS Secretary or designee shall deny an application if the applicant fails to provide the information required, if the Department determines that the information provided is false, or if the patient does not have a debilitating medical condition eligible for enrollment in the program, as determined by the DHSS Secretary. A person whose application has been denied shall not reapply for six months from the date of the denial, unless otherwise authorized by the Department, and is prohibited from all lawful privileges provided by this rule and act.

5.4.1 The Department shall deny an application or renewal of a qualifying patient’s registry identification card if the applicant:

5.4.1.1 Did not provide the required information and materials;

5.4.1.2 Previously had a registry identification card revoked; or

5.4.1.3 Provided false or falsified information.

5.4.2 The Department shall deny an application or renewal for a designated caregiver chosen by a qualifying patient whose registry identification card was granted if:

5.4.2.1 The designated caregiver does not meet the requirements of subsection 4.2;

5.4.2.2 The applicant did not provide the information required;

5.4.2.3 The designated caregiver previously had a registry identification card revoked; or

5.4.2.4 The applicant or the designated caregiver provides false or falsified information.

5.4.3 The Department shall notify the qualifying patient who has designated someone to serve as his or her designated caregiver if a registry identification card will not be issued to the designated caregiver.

5.4.4 Denial of an application or renewal is considered a final Department action, subject to judicial review. Jurisdiction and venue for judicial review are vested in the Superior Court.

5.4.4.1 Denial of an application or renewal for a compassionate use registry identification card is not subject to judicial review.

5.5 Registry identification card renewal application: Each registry identification card issued by the Department is valid in accordance with subsection 5.2. A qualified patient or designated caregiver shall apply for a registry identification card renewal no less than 45 calendar days prior to the expiration date of the existing registry identification card in order to prevent interruption of possession of a valid (unexpired) registry identification card.

5.6 Non-transferable registration of registry identification card: A registry identification card shall not be transferred, by assignment or otherwise, to other persons or locations. Any attempt shall result in the immediate revocation of the registry identification card and all lawful privileges provided by this rule and act.

5.7 Automatic expiration of registry identification card by administrative withdrawal: Upon request the qualified patient or designated caregiver shall discontinue the medical marijuana program by an administrative withdrawal. A qualified patient or designated caregiver that intends to seek an administrative withdrawal shall notify the licensing authority in writing no less than 30 calendar days prior to withdrawal.

**History**
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *15 DE Reg. 1728 (06/01/12)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *15 DE Reg. 1728 (06/01/12)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*

##### **16 Del. Admin. Code § 4470-6.0** Addition of Debilitating Medical Conditions {#sec-4470-6.0 omnilex-key=us-de-regs-official--title-16--4470-6.0}

6.1 Any citizen may petition the Department to add conditions or treatments to the list of debilitating medical conditions listed in 16 Del.C. §4902A(3).

6.2 The Department shall not add a condition or treatment to the list of debilitating medical conditions unless it finds that (1) the medical condition or treatment is debilitating and (2) marijuana is more likely than not to have the potential to be beneficial to treat or alleviate the debilitation associated with the medical condition or treatment.

6.3 Contents of the petition: In connection with any petition to add conditions or treatments to the list of debilitating medical conditions listed in 16 Del.C. §4902A(3), a petitioner shall provide the following information to the Department:

6.3.1 The extent to which the condition is generally accepted by the medical community and other experts as a valid, existing debilitating medical condition;

6.3.2 If one or more treatments of the condition, rather than the condition itself, are alleged to be the cause of the patient’s suffering, the extent to which the treatments causing suffering are generally accepted by the medical community and other experts as valid treatments for the condition;

6.3.3 The extent to which the condition or treatments cause severe suffering, such as severe or chronic pain or severe nausea or vomiting, or otherwise severely impair the patient’s ability to carry on activities of daily living;

6.3.4 The ability of conventional medical therapies other than those that cause suffering to alleviate suffering caused by the condition or treatment;

6.3.5 The extent to which evidence that is generally accepted among the medical community and other experts supports a finding that the use of marijuana alleviates suffering caused by the condition or treatment; and

6.3.6 Letters of support from physicians or other licensed health care professionals knowledgeable about the condition or treatment.

6.3.7 The evidence must indicate the intended patient population and whether it is generally accepted for both adult and pediatric use or limited to a particular population.

6.4 Evaluation of a petition

6.4.1 Upon review of materials submitted in response to subsection 6.3 above, the Division of Public Health (DPH) shall make a determination as to whether the petition has merit.

6.4.2 A petition will be determined to have merit if it contains all of the material required in subsection 6.3 above and the debilitating condition that is the subject of the petition has not been considered through this process in the prior two years, unless significant, generally accepted, scientific discoveries have been made that are substantially likely to reverse the prior decision.

6.4.3 A decision that a petition does not have merit will be made in writing, stating the reason or reasons it has been determined not to have merit and that it is the final decision, subject to judicial review.

6.4.4 A final decision on a petition determined to have merit will be made within 180 days of receipt of the petition in response to the following process.

6.4.4.1 DPH will post the complete petition on the Department's website for a 60-day public comment period.

6.4.4.2 DPH will post notice of a public hearing no fewer than 10 days prior to the public hearing

6.4.4.3 DPH will hold a public hearing within the 60-day public comment period.

6.4.4.4 After the public hearing and closure of the 60-day public comment period, DPH will review the petition and comments. During this review, DPH may conduct additional research, including consultation with additional experts.

6.4.4.5 DPH will draft a written decision on whether to grant the petition and add the debilitating medical condition for review and ultimate decision by the Department Secretary. This written decision will be detailed enough to provide the specific grounds and references to support the decision. The Department Secretary will issue the final decision on the petition.

6.4.4.6 If the petition to add a debilitating medical condition is granted, draft regulations adding the condition to Section 2.0 will be drafted and published in response to the Administrative Procedures Act Process.

6.5 The approval or denial of any petition is a final decision of the Department subject to judicial review. Jurisdiction and venue are vested in the Superior Court.

**History**
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *15 DE Reg. 1728 (06/01/12)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *15 DE Reg. 1728 (06/01/12)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*

##### **16 Del. Admin. Code § 4470-7.0** Registration and Operation of Compassion Centers {#sec-4470-7.0 omnilex-key=us-de-regs-official--title-16--4470-7.0}

7.1 Requirements for operation of a compassion center.

7.1.1 General requirements

7.1.1.1 No person shall operate a compassion center without a Department-issued certificate of registration. The application and renewal requirements for a certificate of registration are in subsections 7.6 and 7.10 of these regulations.

7.1.1.2 A compassion center shall be operated on a not-for-profit basis. A compassion center need not be recognized as a tax-exempt organization by the Internal Revenue Service and is not required to incorporate in response to Title 8; however, a compassion center shall maintain appropriate documentation of its not-for-profit status, and such documentation shall be available for inspection in response to subsection 7.2.7 of these regulations.

7.1.1.3 A compassion center shall not acquire, possess, cultivate, manufacture, deliver, transfer, transport, supply or dispense marijuana for any purpose except to assist registered qualifying patients with the medical use of marijuana directly or through the qualifying patient’s registered designated caregiver.

7.1.1.4 Use of pesticides is prohibited:

7.1.1.4.1 There are no pesticides authorized for use on marijuana; as such, a compassion center shall not apply pesticides in the cultivation of marijuana.

7.1.1.4.2 Prohibited pesticides include but are not limited to the following:

7.1.1.4.2.1 Organochlorines;

7.1.1.4.2.2 Organophosphates;

7.1.1.4.2.3 Carbamates; and

7.1.1.4.2.4 Insecticidal, fungicidal or growth regulatory compounds.

7.1.1.5 Packaging of medical marijuana

7.1.1.5.1 All marijuana products shall be in tamper resistant packaging.

7.1.1.6 Labeling of medical marijuana

7.1.1.6.1 All medical marijuana product labels will contain these minimum requirements:

7.1.1.6.1.1 Name of the patient, patient number and date of sale.

7.1.1.6.1.2 Name of the strain, cannabinoid profile, and quantity of the medical marijuana dispensed.

7.1.1.6.1.3 A statement providing that “this product is for medical use only, not for resale” and indicating the medical marijuana is free of contaminants.

7.1.1.7 Labeling shall include recommendations and instructions for use, including daytime or nighttime use and dosing.

7.1.1.8 Online advertising and marketing are permitted subject to the limitations listed in 16 Del.C. Ch. 49A.

7.1.2 Location of a compassion center: A compassion center shall not be located within 500 feet of the property line of a preexisting public or private school.

7.1.3 Bylaws

7.1.3.1 A compassion center shall, as part of its initial application, provide to the Department a true, correct, and current copy of its bylaws, and shall maintain such bylaws in accordance with the Act and these regulations.

7.1.3.2 The bylaws of a compassion center shall include at a minimum:

7.1.3.2.1 The ownership structure of the compassion center;

7.1.3.2.2 The composition of the board of directors; and

7.1.3.2.3 Such provisions relative to the disposition of revenues to establish and maintain the not-for-profit character of the compassion center.

7.1.4 Maintenance of accurate books and records

7.1.4.1 Registered compassion centers shall keep detailed financial reports of proceeds and expenses.

7.1.4.2 Registered compassion centers shall maintain all inventory, sales and financial records in accordance with generally accepted accounting principles (“GAAP”).

7.1.4.3 An annual financial audit must be conducted by an independent audit firm and submitted to the Department with the compassion center’s annual report.

7.1.4.4 The Department or an audit firm contracted by the Department shall at all times have access to all books and records kept by any compassion center.

7.1.5 Disposal of Unusable Marijuana

7.1.5.1 The medical marijuana inventory system must be updated immediately when a plant is pulled out of inventory for destruction, starting the 72-hour destruction quarantine. The plant number, date and reason must be recorded. This information must be available for auditing by the department.

7.1.5.2 Medical marijuana waste must be stored, secured, and managed in accordance with these regulations and approved operations manual procedures. Medical marijuana waste must be made unusable prior to the waste leaving a registered facility.

7.1.5.3 Liquid waste from medical marijuana facilities shall be disposed of in compliance with the applicable County statutes and regulations including the International Plumbing Code.

7.1.5.4 Medical marijuana waste shall be rendered unusable through grinding and incorporating the medical marijuana waste with non-consumable, solid wastes listed below such that the resulting mixture is at least 50% non-marijuana waste:

7.1.5.4.1 Paper waste,

7.1.5.4.2 Plastic waste,

7.1.5.4.3 Cardboard waste,

7.1.5.4.4 Food waste,

7.1.5.4.5 Soil,

7.1.5.4.6 Grease or other compostable oil waste,

7.1.5.4.7 Other wastes approved by the Division of Public Health that will render the medical marijuana waste unusable.

7.1.5.5 After the medical marijuana waste is made unusable, the solid waste shall be:

7.1.5.5.1 Disposed of as a solid waste at a solid waste site and disposal facility that has a Certificate of Designation from the local governing body,

7.1.5.5.2 Deposited at a compost facility that has a Certificate of Designation from the Department of Natural Resources and Environmental Control (DNREC), or

7.1.5.5.3 Composted on-site at a facility owned by the generator and operated in compliance with applicable County statutes and regulations.

7.2 Security requirements: A compassion center shall implement appropriate security and safety measures to deter and prevent the unauthorized entrance into areas containing marijuana and the theft of marijuana. Such measures shall include the following:

7.2.1 Exterior of premises: With respect to the exterior of a compassion center:

7.2.1.1 Access from outside the premises shall be kept to a minimum and be well controlled.

7.2.1.2 The outside perimeter of the premises shall be well lighted.

7.2.1.3 Entry into any area where marijuana is held shall be limited to authorized personnel.

7.2.2 Alarm system:

7.2.2.1 A compassion center shall have a fully operational security alarm system at each authorized physical address that will provide suitable protection against theft and diversion. For the purpose of these regulations, a fully operational security alarm system shall include:

7.2.2.1.1 Immediate automatic or electronic notification to alert local or municipal law enforcement agencies to an unauthorized breach of security at the compassion center or at any other authorized physical address;

7.2.2.1.2 Immediate automatic or electronic notification to local or municipal public safety personnel of a loss of electrical support backup system; and

7.2.2.1.3 When appropriate, the security system shall provide protection against theft or diversion that is facilitated or hidden by tampering with computers or electronic records.

7.2.2.2 A compassion center shall conduct a maintenance inspection/test of the alarm system for each authorized location at intervals not to exceed 30 days from the previous inspection/test. A compassion center shall promptly make all necessary repairs to ensure the proper operation of the alarm system.

7.2.2.3 In the event of a failure of the security system, due to loss of electrical support or mechanical malfunction, that is expected to exceed an eight-hour period, a compassion center shall:

7.2.2.3.1 Within 24 hours of discovery of the event, notify the Department by telephone; and

7.2.2.3.2 Provide alternative security measures approved by the Department or close the authorized physical addresses impacted by the failure/malfunction until the security alarm system has been restored to full operation.

7.2.2.4 A compassion center shall maintain documentation in an auditable form for a period of at least 24 months after the event for:

7.2.2.4.1 All maintenance inspections/tests conducted in response to subsection 7.2.2.2 of these regulations, and any servicing, modification or upgrade performed on the security alarm system. The record shall include, as a minimum, the date of the action, a summary of the actions performed and the name, signature and title of the individual who performed the actions;

7.2.2.4.2 Any alarm activation or other event which requires response by public safety personnel; and

7.2.2.4.3 Any unauthorized breach of security.

7.2.3 Video surveillance: A compassion center shall provide an appropriate video surveillance system that includes the following areas and access to recorded surveillance.

7.2.3.1 Video surveillance should record access areas, customer service areas, growing areas, and anywhere the marijuana is handled, to include processing and packaging areas.

7.2.3.2 Video footage will be digitally recorded and held for 90 days for routine footage or up to 36 months if video contains information of significance.

7.2.3.3 A compassion center shall provide the Department with access to the video 24-hours a day, seven days a week through a secure internet connection.

7.2.4 Inventory controls

7.2.4.1 Coding and computer interface: A compassion center shall:

7.2.4.1.1 Employ a barcoding inventory control system to track batch, strain and amounts of marijuana in inventory and amounts sold, to include patients’ card registration numbers. All plants, regardless of stage of growth must have the strain and barcode label affixed to the plant or container for immature plants.

7.2.4.1.2 Be responsible for developing and hosting a secure computer interface to connect with DEC3S.

7.2.4.2 Storage of marijuana: A compassion center shall ensure that usable marijuana is stored in a locked area with adequate security. For purpose of these regulations “adequate security,” at a minimum, should be assessed, established and maintained based on:

7.2.4.2.1 The quantity of usable marijuana that will be kept on hand at each authorized location;

7.2.4.2.2 The compassion center’s inventory system for tracking and dispensing usable marijuana;

7.2.4.2.3 The number of principal officers, board members, agents, volunteers or employees who have or could have access to the usable marijuana;

7.2.4.2.4 The geographic location of the compassion center (i.e.: high-crime or low-crime area);

7.2.4.2.5 The scope and sustainability of the alarm system; and

7.2.4.2.6 The root cause analysis of any breach of security and/or inventory discrepancy for usable marijuana at that location.

7.2.5 Comprehensive and monthly inventories

7.2.5.1 A compassion center shall:

7.2.5.1.1 Notify the Department and local law enforcement within 24 hours any time there is a suspected loss of marijuana and shall cooperate fully with any investigation into the suspected loss.

7.2.5.1.2 Conduct an initial comprehensive inventory of all medical marijuana, including usable marijuana available for dispensing, mature marijuana plants and unusable marijuana, at each authorized location on the date the compassion center first dispenses medical marijuana.

7.2.5.1.3 Conduct the comprehensive inventory required by subsection 7.2.5 of these regulations at intervals not to exceed 24 months from the date of the previous comprehensive inventory.

7.2.5.1.4 Conduct a monthly inventory review of stored, usable marijuana.

7.2.5.2 If an inventory conducted in response to subsection 7.2.5.1 of these regulations identifies a discrepancy, the Department and appropriate local law enforcement authorities will be notified of the discrepancy within 24 hours of discovery of the event.

7.2.5.3 Documentation of all inventories conducted in response to subsection 7.2.5.1 of these regulations shall include, as a minimum, the date of the inventory, a summary of the inventory findings and the name, signature and title of the individual or individuals who conducted the inventory.

7.2.6 Maximum amount of compassion center inventory. A registered compassion center:

7.2.6.1 Shall grow an amount of marijuana sufficient to meet the qualifying patient population demands as determined by the Division.

7.2.6.2 Shall possess no more than 1,000 pounds of usable marijuana regardless of formulation unless a variance is approved by the OMM Director.

7.2.6.3 May not purchase usable marijuana or mature marijuana plants from any person other than another registered compassion center.

7.2.7 Compassion centers are subject to random inspection by the Department’s Office of Medical Marijuana.

7.2.7.1 During an inspection, the Department may review the compassion center’s confidential records, including its financial and dispensing records, which may track transactions according to qualifying patients’ registry identification numbers to protect their confidentiality and its security protocols.

7.2.7.2 The Department will review the facility to ensure compliance with subsections 7.2 and 7.3 of these regulations.

7.2.7.3 The Department will inspect the facility for the presence of pesticides listed in subsection 7.1.1.4, fungus and molds.

7.2.7.4 The Department may collect samples for random quality sampling by a laboratory selected by the Department.

7.2.7.4.1 The compassion center will be invoiced for the cost of random sampling testing.

7.2.7.5 The Department will review the facility for compliance with applicable federal, state and local standards.

7.2.7.6 Hazard Chemical Storage

7.2.7.6.1 The Department will inspect the facility for the presence of butane, hexane, pentane, and propane; or extraction techniques that may produce hazardous conditions. Any form of alkane or petroleum hydrocarbon extraction is unauthorized in Delaware.

7.2.8 Dispensing marijuana

7.2.8.1 Design and security features of medical marijuana containers.

7.2.8.1.1 Marijuana shall be dispensed in sealed, tamperproof containers clearly identified as having been issued by the compassion center and that meet the requirements in subsection 7.3.10 of these regulations.

7.2.8.1.2 Patients and designated caregivers should receive written instruction that the marijuana shall remain in this container when it is not being prepared for ingestion or being ingested.

7.2.8.2 No marijuana shall be dispensed unless or until the patient or caregiver identification card has been verified as valid in the computer system identified in subsection 7.2.4.1.2 of these regulations.

7.2.8.3 Maximum amount of usable marijuana to be dispensed.

7.2.8.3.1 A compassion center or principal officer, board member, agent, volunteer or employee of a compassion center:

7.2.8.3.1.1 Shall not dispense, deliver or otherwise transfer marijuana to a person other than a qualifying patient or to such patient’s other designated caregiver.

7.2.8.3.1.2 Shall not dispense more than three ounces of usable marijuana to a qualifying patient directly or through a qualifying patient’s caregiver during a 14-day period.

7.2.8.3.1.3 Shall not dispense an amount of usable marijuana to a qualifying patient or a qualifying patient’s caregiver that the compassion center principal officer, board member, agent, volunteer or employee knows would cause the recipient to possess more marijuana than is permitted under the Act or these regulations.

7.2.8.3.1.4 Shall dispense pediatric medical marijuana oils as described in Section 2.0 of these regulations to qualified patients under the age of 18 years. Patients under the age of 18 are restricted from purchasing products other than pediatric medical marijuana oil.

7.2.8.3.1.4.1 Any materials used in production of marijuana products will have Generally Recognized As Safe (GRAS) documentation and used as directed.

7.2.8.3.1.5 Cannabidiol-Rich medical marijuana must contain near equal concentrations of tetrahydrocannabinol and Cannabidiol, regardless of the form.

7.2.8.3.1.5.1 Flower strains produced to be compliant as CBD-Rich marijuana must be clearly identified.

7.2.8.3.1.5.2 Concentrates, vapes, capsules and edibles produced to be CBD-Rich compliant must be clearly identified.

7.2.8.3.2 In addition to any other penalties that may be applicable under the Act or these regulations, any person found to have violated subsection 7.2.8 of these regulations is not eligible to be an employee, agent, principal officer or board member of any compassion center and such person’s registry identification card shall be immediately revoked.

7.3 Operations manual. A compassion center shall, as part of its initial application, provide to the Department a true, correct and current copy of its operating manual, and shall maintain such operating manual in accordance with the Act and these regulations. Such manual shall include, as a minimum, the following requirements:

7.3.1 Procedures for the oversight of the compassion center including, but not limited to, documentation of the reporting and management structure of the compassion center;

7.3.2 Procedures for safely dispensing medical marijuana to registered qualifying patients or their registered designated caregiver;

7.3.3 Procedures to ensure accurate record keeping, including protocols to ensure that quantities purchased do not suggest re-distribution;

7.3.4 Employee security policies;

7.3.5 Safety and security procedures, including a disaster plan with procedures to be followed in case of fire or other emergencies;

7.3.6 Personal safety and crime prevention techniques;

7.3.7 A job description or employment contract developed for all employees and a volunteer agreement for all volunteers which includes duties, responsibilities, authority, qualification and supervision;

7.3.8 The compassion center’s alcohol and drug free workplace policy;

7.3.9 A description of the compassion center’s outreach activities to registered qualifying patients or their registered designated caregiver, which shall as a minimum include:

7.3.9.1 Providing each new registered patient who visits the compassion center with frequently asked questions, designed by the Department, that explain the limitations on the right to use medical marijuana under state law;

7.3.9.2 Ingestion options of usable marijuana provided by the compassion center;

7.3.9.3 Safe smoking techniques that shall be provided to registered qualifying patients; and

7.3.9.4 Potential side effects and how this information shall be communicated.

7.3.10 A description of the packaging of the useable marijuana that the compassion center shall be utilizing which shall, as a minimum, include:

7.3.10.1 The name of the strain, batch, and quantity;

7.3.10.2 The statement “this product is for medical use only, not for resale”; and

7.3.10.3 Details indicating (1) the medical marijuana is free of contaminants and (2) the levels of active ingredients in the product.

7.3.11 A description of the documentation that will accompany a registered compassion center agent when transporting marijuana on behalf of the registered compassion center. In response to 16 Del.C. §4918A(b), the documentation must specify, at least, the amount of marijuana being transported, the date the marijuana is being transported, the registry identification number of the registered compassion center, and a contact number to verify that the marijuana is being transported on behalf of the registered compassion center.

7.3.12 Detailed procedures regarding the random sampling of medical marijuana. OMM staff will supervise selection of samples from the curing vessels with the Compassion Center staff.

7.3.12.1 Compassion Center staff will prepare additional barcode labels and tamper-proof containers for each plant scheduled to be sampled and develop a transportation manifest, initiating the chain of custody process for the batch of plants being tested;

7.3.12.2 The Compassion Centers will not sell or prepare products from the batch being tested until the Safety and Compliance Center enter the values into the DEC3S program, releasing the material for use or sale;

7.3.12.3 Any concentrates or other infused products must be sent to the Safety and Compliance Center for testing, using the manifest process listed above before the batch being tested is cleared for sale;

7.3.12.4 Sample results will be loaded into the DEC3S system by the Safety and Compliance Center allowing Compassion Centers to sell the material or incorporate it into other products; and

7.3.12.5 Compassion Centers will coordinate directly with the Safety and Compliance Center on invoicing and payment for testing services.

7.4 Required training. Each compassion center shall develop, implement and maintain on the premises an on-site training curriculum, or enter into contractual relationships with outside resources capable of meeting employee, agent and volunteer training needs. Each employee, agent or volunteer, at the time of initial appointment, shall receive, as a minimum, training in the following:

7.4.1 Professional conduct, ethics, and state and federal laws regarding patient confidentiality;

7.4.2 Informational developments in the field of medical use of marijuana;

7.4.3 The proper use of security measures and controls that have been adopted; and

7.4.4 Specific procedural instructions for responding to an emergency, including robbery or violent accident.

7.5 Personnel

7.5.1 Records. Each compassion center shall maintain:

7.5.1.1 A personnel record for each employee, agent or volunteer for a period of at least six months after termination of the individual’s affiliation with the compassion center. The record shall include, as a minimum, the following:

7.5.1.1.1 An application for employment or to volunteer;

7.5.1.1.2 A record of any disciplinary action taken;

7.5.1.1.3 Documentation of all required training. Documentation shall include a signed statement from the individual indicating the date, time and place of said training and topics discussed, including the name and title of presenters;

7.5.1.2 A record of the source of any funds that will be used to open or maintain the compassion center, including the name, address, and date of birth of any investor contributing more than $5,000; and

7.5.1.3 A record of any instances in which a business or not-for-profit that any of the prospective board members managed or served on the board of was convicted, fined, censured, or had a registration or license suspended or revoked in any administrative or judicial proceeding.

7.5.2 Registry identification cards and background checks for principal officers, board members, agents, volunteers or employees of a compassion center.

7.5.2.1 In response to the requirements of this rule, and upon the approval of the submitted application, the Department shall issue a registry photo identification card to each principal officer, board member, agent, volunteer or employee of a compassion center who is associated with the compassion center and meets the requirements under these regulations. In order for a registry identification card to be obtained, the following items shall be submitted to the medical marijuana program.

7.5.2.1.1 Documentation verifying that the applicant is at least 21 years of age;

7.5.2.1.2 A reasonable xerographic copy of the applicant’s Delaware license or comparable State of Delaware or federal issued photo identification card verifying Delaware residence; identification card must be available for inspection/verification;

7.5.2.1.3 A written and signed statement from an officer or executive staff member of the compassion center stating that the applicant is associated with the compassion center and in what capacity;

7.5.2.1.4 The name, address and telephone number of the applicant;

7.5.2.1.5 The name, address and telephone number of the compassion center with which the agent is associated;

7.5.2.1.6 The applicant’s signature and date;

7.5.2.1.7 A non-refundable, non-returnable application or renewal fee of $125 in the form of a check made out to “State of Delaware-MMP”.

7.5.2.2 In response to 16 Del.C. §§4914A and 4915A, each principal officer, board member, agent, volunteer or employee of a compassion center shall consent to a full nationwide and statewide criminal history screening background check.

7.5.2.2.1 Each applicant shall submit a full State Bureau of Identification (SBI) criminal history screening check and a full nationwide criminal history screening check to demonstrate compliance with the eligibility requirements of these regulations.

7.5.2.2.2 All applicable fees associated with the required criminal history screening background checks shall be paid by the compassion center or the applicant.

7.5.2.2.3 In response to 16 Del.C. §4919A(n), individuals convicted of an excluded felony offense, as described in the definitions Section 2.0, and 16 Del.C. §4902A(7), within five years from the date of application, are prohibited from being a compassion center agent.

7.5.2.3 The Department may verify information on each application and the accompanying documentation as set forth in subsection 5.1 of these regulations.

7.5.2.4 The Department shall notify the compassion center in writing of the purpose for denying the registry identification card in accordance with § 4918A of the Act. The DHSS Secretary or designee shall deny an application if the applicant fails to provide the information required or if the Department determines that the information provided is false. Denial of an application or renewal is considered a final Department action, subject to judicial review. Jurisdiction and venue for judicial review are vested in the Superior Court.

7.5.2.5 The Department shall issue each principal officer, board member, agent, volunteer or employee of a compassion center a registry identification card within 30 days of receipt of the information required by subsections 7.5.2.1 and 7.5.2.2. The registry identification card shall contain such information as set forth in §4911A of the Act and subsection 7.5.2 of these regulations.

7.5.2.6 Each compassion center shall notify the Department in writing within ten days of when a principal officer, board member, agent, volunteer or employee ceases to work at the compassion center. The individual’s registry identification card shall be deemed null and void and the individual shall be liable for any other penalties that may apply to the individual’s nonmedical use of marijuana.

7.5.3 Expiration date of registry identification cards. The registry identification card of a principal officer, board member, agent, volunteer or employee shall expire one year after its issuance, or upon the expiration of the compassion center’s registration certificate, whichever comes first.

7.5.3.1 Every principal officer, board member, agent, volunteer or employee of a compassion center must have a valid, unexpired registry identification card issued by the Office of Medical Marijuana.

7.6 Application for operation of a compassion center. Applicants shall only be accepted during an open application period announced by the Department and shall include the following items:

7.6.1 A non-refundable application fee, made payable to the Division of Public Health, Medical Marijuana Program, in the amount of $5,000;

7.6.2 The proposed legal name, articles of incorporation and bylaws of the compassion center;

7.6.3 The proposed physical address or addresses of the compassion center, including any additional addresses to be used for the secure cultivation of medical marijuana, and with the following details:

7.6.3.1 If precise addresses are known, evidence of compliance to the following rules shall be included:

7.6.3.1.1 Compliance to the local zoning laws for each physical address to be utilized as a compassion center or for the secure cultivation of medical marijuana;

7.6.3.1.2 Evidence that all of the physical addresses identified in this subsection are not located within 500 feet of a property line of a preexisting public or private school;

7.6.3.2 If precise addresses have not been determined, identification of the general locations where it would be sited, and when it would be established;

7.6.4 A description of the enclosed, locked facility, meeting all requirements of subsection 7.2 that would be used in the cultivation of marijuana, including steps to ensure that the marijuana production shall not be visible from the street or other public areas;

7.6.5 Evidence of the compassion center’s not-for-profit status, which can be:

7.6.5.1 Documentation of recognition as a tax-exempt organization by the United States Internal Revenue Service; or

7.6.5.2 Other written materials which will allow the Department to determine the compassion center’s ability to comply with the revenue criteria contained in 16 Del.C. §4914A and §4915A.

7.6.6 The name, address, and date of birth of each principal officer and board member of the compassion center;

7.6.7 A description of proposed security and safety measures which demonstrate compliance with subsection 7.2 of these regulations;

7.6.8 A draft operations manual which demonstrates compliance with subsection 7.3 of these regulations;

7.6.9 An example of the design and security features of medical marijuana containers which demonstrates compliance with subsection 7.2.8 of these regulations;

7.6.10 A list of all persons or business entities having direct or indirect authority over the management or policies of the compassion center;

7.6.11 A list of all persons or business entities having 5.0% or more ownership in the compassion center, whether direct or indirect and whether the interest is in profits, land or building, including owners of any business entity which owns all or part of the land or building; and

7.6.12 The identities of all creditors holding a security interest in the premises, if any.

7.7 Complete application required. Only applications which the Department has determined to be complete (i.e. adequately addresses all requirements in these regulations and 16 Del.C. §§4914A and 4915A) shall be eligible for review in response to subsection 7.8 of these regulations.

7.8 Compassion center application review criteria. The Department shall evaluate applications for a compassion center registration certificate using an impartial and numerically scored competitive bidding process developed by the Department in accordance with 16 Del.C. §4914A(b) and these regulations. The Department shall consider the following criteria:

7.8.1 Documentation of not-for-profit status, consistent with subsection 7.6.5 of these regulations;

7.8.2 The suitability of the proposed location or locations, including but not limited to compliance with any local zoning laws and the geographic convenience to patients from throughout the State of Delaware to compassion centers if the applicant were approved;

7.8.3 The principal officer and board members’ character and relevant experience, including any training or professional licensing related to medicine, pharmaceuticals, natural treatments, botany, or marijuana cultivation and preparation and their experience running business or not-for-profit entities;

7.8.4 The proposed compassion center’s plan for operations and services, including its staffing and training plans, whether it has sufficient capital to operate, and its ability to provide an adequate supply and variety of medical marijuana and medical marijuana based products to the registered patients in the State;

7.8.5 The sufficiency of the applicant’s plans for record keeping;

7.8.6 The sufficiency of the applicant’s plans for safety, security, and the prevention of diversion, including proposed locations and security devices employed;

7.8.7 The applicant’s plan for making medical marijuana available on an affordable basis to registered qualifying patients enrolled in Medicaid or receiving Supplemental Security Income or Social Security Disability Insurance;

7.8.8 The applicant’s plan for safe and accurate packaging and labeling of medical marijuana, which shall include, without limitations, these minimum requirements for packaging and labeling:

7.8.8.1 The name of the strain, batch, and quantity of the medical marijuana;

7.8.8.2 A statement providing that “this product is for medical use only, not for resale”;

7.8.8.3 Details indicating the medical marijuana is free of contaminants;

7.8.8.4 Details indicating the levels of active ingredients in the product; and

7.8.9 The applicant’s ability to grow marijuana without use of pesticides.

7.9 Issuance of a registration certificate authorizing operation of a compassion center. When an applicant to operate a compassion center is notified that the Department has approved its application, it shall submit the following additional items to the Department before the registration certificate authorizing operation of a compassion center will be issued.

7.9.1 A certification fee, made payable to “State of Delaware-MMP” in the amount of $40,000;

7.9.2 The legal name, articles of incorporation, and bylaws of the compassion center;

7.9.3 The physical address of the compassion center and any additional addresses to be used for the secure cultivation of marijuana, including:

7.9.3.1 Evidence demonstrating the following:

7.9.3.1.1 Compliance with all local zoning laws for each physical address to be utilized as a compassion center or for the secure cultivation of medical marijuana; and

7.9.3.1.2 That none of the physical addresses identified in subsection 7.9.3 of these regulations are located within 500 feet of the property line of preexisting public or private schools;

7.9.3.2 It is not necessary to resubmit any information provided in response to subsection 7.6.3.1 of these regulations unless there has been a change in that information;

7.9.4 Any updates to previously submitted information including, but not limited to, information about officers, principals, board members, agents, employees, and compliance with subsections 7.2 and 7.3 of these regulations;

7.9.5 A current certificate of occupancy, or equivalent document, to demonstrate compliance with the provisions of the State Fire Code for each physical address to be utilized as a compassion center or for the secure cultivation of medical marijuana.

7.10 Expiration, termination, or renewal of a registration certificate authorizing operation of a compassion center.

7.10.1 Expiration: A compassion center’s registration shall expire two years after its registration certificate is issued. The compassion center may submit a renewal application at any time beginning 90 days prior to the expiration of its registration certificate. Such renewal application must be submitted a minimum of 30 days prior to the expiration of its registration certificate to avoid suspension of the certificate.

7.10.2 Renewal. The Department shall grant a compassion center’s renewal application within 30 days of its submission if the following conditions are all satisfied:

7.10.2.1 The compassion center submits materials required under subsection 7.9 of these regulations, including a summary annual report with financial audit attached, a comprehensive inventory with a cover letter and the $40,000 fee, which shall be refunded if the renewal application is rejected;

7.10.2.2 The Department has not ever suspended the compassion center’s registration for violations of the Act or these regulations;

7.10.2.3 Inspections conducted pursuant to the Act and these regulations do not raise any serious concerns about the continued operation of the registered compassion center applying for renewal; and

7.10.2.4 The applicant continues to meet all of the requirements for the operation of a compassion center as set forth in the Act and in these regulations.

7.10.3 Suspension: The Department will suspend a registration certificate authorizing the operation of a compassion center, with or without notice, for any violation of an applicable law or regulation.

7.10.4 Termination: Upon receipt of written notice that a registration certificate has been terminated, the compassion center has 30 business days to request, in writing, a hearing, for the purpose of review of such action. The hearing process shall follow the procedures in subsections 9.4 through 9.5.10 of these regulations:

7.10.4.1 A written decision will be issued by the Department within 30 days of the completion of the hearing. The decision will lift the suspension or terminate a registration certificate. The written decision will state with specificity the reasons for the decision.

7.10.4.2 The termination of a registration certificate is a final decision of the Department, subject to judicial review. Jurisdiction and venue are vested in the Superior Court.

7.11 Non-transferable registration certificate authorizing operation of a compassion center.

7.11.1 A registration certificate authorizing operation of a compassion center shall not be transferred by assignment or otherwise to other persons or locations. Unless the compassion center applies for and receives an amended registration certificate authorizing operation of a compassion center, the registration certificate shall be void and returned to the Department when one or more of the following situations occur:

7.11.1.1 A change in ownership of the compassion center;

7.11.1.2 A change in one or more authorized physical locations; or

7.11.1.3 The compassion center discontinues its operation.

7.11.2 A compassion center shall provide the Department with a written notice of any change described in subsection 7.11 of these regulations at least 60 days prior to the proposed effective date of the change. The Department may waive all or part of the required advance notice to address emergent or emergency situations.

7.11.3 Transactions which usually do not constitute a change of ownership include the following:

7.11.3.1 Changes in the membership of the board of directors or board of trustees; or

7.11.3.2 Two or more legal entities merge and the entity to whom the registration certificate authorizing operation of a compassion center was issued survives.

7.11.4 Management agreements are generally not considered a change in ownership if the entity to whom the registration certificate authorizing operation of a compassion center was issued continues to retain ultimate authority for the operation of the compassion center; however, if the ultimate authority is surrendered and transferred from the entity to whom the registration certificate authorizing operation of a compassion center was issued to a new manager, then a change of ownership has occurred.

7.12 Compassion centers that offer medical marijuana home delivery to registered patients must develop and field a computer inventory system that integrates with DEC3S.

7.12.1 Compassion centers must pre-register qualified patients for home delivery.

7.12.2 Compassion centers must establish protocols for identifying the patient and receiving payment.

7.12.3 Compassion centers must use a comprehensive manifest and invoicing program to ensure the correct products are delivered to the appropriate, positively identified patient.

7.12.4 Compassion centers will be responsible for submitting a plan to the Office of Medical Marijuana detailing how safe transportation and delivery services will be accomplished. This plan must be approved by OMM before delivery services can begin.

7.12.4.1 The Office of Medical Marijuana may rescind approval of the home delivery plan for failure to comply with the approved plan, these regulations or the Medical Marijuana Act.

**History**
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *15 DE Reg. 1728 (06/01/12)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *15 DE Reg. 1728 (06/01/12)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*

##### **16 Del. Admin. Code § 4470-8.0** Registration and Operation of Safety Compliance Facilities {#sec-4470-8.0 omnilex-key=us-de-regs-official--title-16--4470-8.0}

8.1 General Requirements for Operation of a Safety Compliance Facility

8.1.1 A Safety Compliance Facility may only operate if they have been issued a valid registration certificate from the Department.

8.1.2 A Safety Compliance Facility must be operated in accordance with the International Organization for Standardization 17025 (ISO 17025) standards as confirmed by accreditation by a third-party accrediting body or a qualified auditing organization using ISO 17025 criteria approved by the Department.

8.2 Security Requirements

8.2.1 A Safety Compliance Facility shall implement appropriate security and safety measures to deter and prevent the unauthorized entrance into areas containing marijuana and the theft of marijuana. Such measures shall include the following:

8.2.1.1 Exterior of premises

8.2.1.1.1 With respect to the exterior of a Safety Compliance Facility:

8.2.1.1.1.1 Access from outside the premises shall be kept to a minimum and be well controlled;

8.2.1.1.1.2 The outside perimeter of the premises shall be well lit; and

8.2.1.1.1.3 Entry into any area where marijuana is held shall be limited to authorized personnel.

8.2.1.2 Alarm system

8.2.1.2.1 A Safety Compliance Facility shall have a fully operational security alarm system that will provide suitable protection against theft and diversion. For the purpose of these regulations, a fully operational security alarm system shall include:

8.2.1.2.1.1 Immediate automatic or electronic notification to alert local or municipal law enforcement agencies of an unauthorized breach of security at the Safety Compliance Facility or at any other authorized physical address;

8.2.1.2.1.2 Immediate automatic or electronic notification to local or municipal public safety personnel of a loss of electrical support backup system; and

8.2.1.2.1.3 When appropriate, the security system shall provide protection against tampering with computers or electronic records done to conceal theft or diversion.

8.2.1.2.2 A Safety Compliance Facility shall conduct a maintenance inspection/test of the alarm system for each authorized location at intervals not to exceed 30 days from the previous inspection/test. A Safety Compliance Facility shall promptly make all necessary repairs to ensure the proper operation of the alarm system.

8.2.1.2.3 In the event of a failure of the security system, due to loss of electrical support or mechanical malfunction, that is expected to exceed an eight-hour period, a Safety Compliance Facility shall:

8.2.1.2.3.1 Within 24 hours of discovery of the event, notify the Department by telephone; and

8.2.1.2.3.2 Provide alternative security measures approved by the Department or close the authorized physical addresses affected by the failure/malfunction until the security alarm system has been restored to full operation.

8.2.1.2.4 A Safety Compliance Facility shall maintain documentation in an auditable form for a period of at least 24 months after the event for:

8.2.1.2.4.1 All maintenance inspections/tests conducted in response to subsection 8.2.1.2.4 of these regulations, and any servicing, modification or upgrade performed on the security alarm system. The record shall include, at a minimum, the date of the action, a summary of the actions performed and the name, signature and title of the individual who performed the actions.

8.2.1.2.4.2 Any alarm activation or other event which requires response by public safety personnel; and

8.2.1.2.4.3 Any unauthorized breach of security.

8.2.1.3 Video surveillance

8.2.1.3.1 A Safety Compliance Facility shall provide an appropriate video surveillance system that includes the following areas and access to recorded surveillance.

8.2.1.3.1.1 Video surveillance should record access areas and anywhere the marijuana is handled;

8.2.1.3.1.2 Video footage will be digitally recorded and held for an appropriate time period consistent with the Division of Public Health's Records Retention Policy; and

8.2.1.3.1.3 A Safety Compliance Facility shall provide the Department with access to the video 24-hours a day, seven days a week through a secure internet connection.

8.2.1.4 Inventory controls

8.2.1.4.1 Coding and computer interface

8.2.1.4.1.1 A Safety Compliance Facility shall employ a barcoding inventory control system to track the source, strain, batch and weight of marijuana sample in inventory.

8.2.1.4.2 Storage of marijuana

8.2.1.4.2.1 A Safety Compliance Facility shall ensure that marijuana is stored in a locked area with adequate security. For purpose of these regulations “adequate security,” at a minimum, should be assessed, established and maintained based on:

8.2.1.4.2.1.1 The quantity of marijuana present;

8.2.1.4.2.1.2 The geographic location of the Safety Compliance Facility (i.e.: high-crime or low-crime area); and

8.2.1.4.2.1.3 The scope and sustainability of the alarm system.

8.3 Operations Manual

8.3.1 A Safety Compliance Facility shall, as part of its initial application, provide to the Department a true, correct and current copy of its operations manual, and shall maintain such operations manual in accordance with the Act and these regulations. Such manual shall include, at a minimum, the following requirements:

8.3.1.1 Procedures for the oversight of the Safety Compliance Facility including, but not limited to, documentation of the reporting and management structure of the Safety Compliance Facility;

8.3.1.2 Procedures to ensure accurate record keeping;

8.3.1.3 Employee security policies;

8.3.1.4 Safety and security procedures, including a disaster plan with procedures to be followed in case of fire or other emergencies;

8.3.1.5 Crime prevention techniques;

8.3.1.6 A job description or employment contract developed for all employees which includes duties, responsibilities, authority, qualification and supervision;

8.3.1.7 The Safety Compliance Facility’s alcohol and drug free workplace policy;

8.3.1.8 A description of the documentation that will accompany a registered Safety Compliance Facility agent when transporting marijuana on behalf of the registered Safety Compliance Facility. As required by 16 Del.C. §4918A(b), the documentation must specify, at least, the amount of marijuana being transported, the date the marijuana is being transported, the registry identification number of the registered Safety Compliance Facility, and a contact number to verify that the marijuana is being transported on behalf of the registered Safety Compliance Facility;

8.3.1.9 Detailed procedures regarding the testing of medical marijuana. As part of its initial application, a Safety Compliance Facility shall provide to the Department detailed procedures regarding the testing of medical marijuana, and shall adhere to such procedures in connection with the operation of the Safety Compliance Facility;

8.3.1.9.1 Each batch of medical marijuana harvested by a compassion center shall be tested in accordance with this regulation.

8.3.1.10 Such procedures shall include a description of how the marijuana will be tested including:

8.3.1.10.1 What tests are conducted;

8.3.1.10.2 What testing procedures are used;

8.3.1.10.3 How results are loaded into DEC3S;

8.3.1.10.4 How disposal of samples is tracked;

8.3.1.10.5 The selection process; and

8.3.1.10.6 The number of samples tested.

8.3.1.11 What equipment will be used to test and report on including:

8.3.1.11.1 Potency and cannabinoid profile;

8.3.1.11.2 Contaminates including mold, mildew and organic material;

8.3.1.11.3 Plant growth regulators;

8.3.1.11.4 Pesticides;

8.3.1.11.5 Microbiological contaminants and mycotoxins; and

8.3.1.11.6 Residual solvents.

8.3.1.12 What levels or combination of contaminants mandate elimination of a batch.

8.4 Required Training

8.4.1 Each Safety Compliance Facility shall develop, implement and maintain on the premises an on-site training curriculum, or enter into contractual relationships with outside resources capable of meeting employee and agent training needs. Each employee or agent at the time of initial appointment, shall receive, as a minimum, training in the following:

8.4.1.1 Professional conduct, ethics, and state and federal laws;

8.4.1.2 The proper use of security measures and controls that have been adopted; and

8.4.1.3 Specific procedural instructions for responding to an emergency, including robbery or an accident resulting in injury, fire or damage to critical equipment.

8.5 Personnel Records

8.5.1 Each Safety Compliance Facility shall maintain a personnel record for each employee or agent for a period of at least six months after termination of the individual’s affiliation with the Safety Compliance Facility. The record shall include, as a minimum, the following:

8.5.1.1 An application for employment or to volunteer;

8.5.1.2 A record of any disciplinary action taken;

8.5.1.3 Documentation of all required training. Documentation shall include a signed statement from the individual indicating the date, time and place of said training and topics discussed, including the name and title of presenters.

8.6 Application for Operation of a Safety Compliance Facility

8.6.1 A Safety Compliance Facility may only operate if they have been issued a valid registration certificate from the Department. When applying for a Safety Compliance Facility registration certificate, the applicant shall submit the following in accordance with these regulations:

8.6.1.1 The proposed legal name of the Safety Compliance Facility;

8.6.1.2 The proposed physical address of the Safety Compliance Facility;

8.6.1.3 The name, address, and date of birth of each principal officer and board member of the Safety Compliance Facility, provided that all such individuals shall be at least 21 years of age; and

8.6.1.4 Any information required by the Department to evaluate the applicant pursuant to the competitive bidding process.

8.7 Safety Compliance Facility Application Review Criteria

8.7.1 The Department shall evaluate applications for Safety Compliance Facility registration certificates using an impartial and numerically scored process developed by the Department in accordance with this chapter. The registration considerations shall consist of the following criteria:

8.7.1.1 The proposed principal officers’ and board members’ relevant experience, including any training or professional licensing related to analytical testing, medicine, pharmaceuticals, natural treatments, botany, or marijuana cultivation, preparation, and testing and their experience running businesses or not-for-profits;

8.7.1.2 The suitability of the proposed location, including compliance with any local zoning laws and the geographic convenience to compassion centers throughout the state of Delaware;

8.7.1.3 The sufficiency of the applicant’s plans for safety, security, and the prevention of diversion, including proposed locations and security devices employed; and

8.7.1.4 The proposed Safety Compliance Facility’s plan for operations and services, including its staffing and training plans, and whether it has sufficient capital to operate.

8.8 Issuance of Registration Certificate Authorizing Operation of a Safety Compliance Facility

8.8.1 An application for a Safety Compliance Facility registration certificate must be denied if any of the following conditions are met:

8.8.1.1 Applicant failed to submit the materials required by this subsection, including if the plans do not satisfy the security, oversight, or recordkeeping regulations issued by the Department;

8.8.1.2 Applicant would not be in compliance with local zoning regulations issued in accordance with 16 Del.C. §4917A; or

8.8.1.3 Applicant does not meet the requirements of 16 Del.C. §4919A.

8.8.2 After a Safety Compliance Facility is approved, but before it begins operations, it shall submit a registration fee paid to the Department in the amount of $40,000 and, if a physical address had not been finalized when it applied, its physical address.

8.8.3 The Department shall issue a renewable registration certificate with an identification number after a satisfactory compliance inspection by the Department.

8.9 Registry Identification Cards for Principal Officers, Board Members, Agents, Volunteers or Employees of a Safety Compliance Facility

8.9.1 An application for a registry identification cards must be denied if any of the following conditions are met:

8.9.1.1 If the prospective principal officer or board members has been convicted of an excluded felony offense;

8.9.1.2 If the prospective principal officer or board members has served as a principal officer or board member for a registered Safety Compliance Facility or registered compassion center that has had its registration certificate revoked; or

8.9.1.3 If the principal officer or board members is younger than 21 years of age.

8.9.2 A record of the source of any funds that will be used to open or maintain the Safety Compliance Facility, including the name, address, and date of birth of any investor contributing more than $5,000.

8.9.3 A record of any instances in which a business or not-for-profit that any of the prospective board members managed or served on the board of was convicted, fined, censured, or had a registration or license suspended or revoked in any administrative or judicial proceeding.

8.10 Expiration Date

8.10.1 A Safety Compliance Facility registration shall expire two years after its registration certificate is issued. The Safety Compliance Facility may submit a renewal application at any time beginning 90 days prior to the expiration of its registration certificate. Such renewal application must be submitted a minimum of 30 days prior to the expiration of its registration certificate to avoid suspension of the certificate.

8.11 Expiration, Termination or Renewal of a Registration Certificate Authorizing Operation of a Safety Compliance Facility

8.11.1 Registration certificates may be renewed every two years. The registered Safety Compliance Facility may submit a renewal application beginning 90 days prior to the expiration of its registration certificate. The Department shall grant a renewal application within 30 days of its submission if the following conditions are all satisfied:

8.11.1.1 The registered Safety Compliance Facility submits a renewal application and the required $40,000 renewal fee, which shall be refunded if the renewal application is rejected;

8.11.1.2 The Department has not suspended the registered Safety Compliance Facility’s registration certificate for violations of this chapter or regulations adopted pursuant to this chapter;

8.11.1.3 The inspections authorized by 16 Del.C. §4919A(u) do not raise serious concerns about the continued operation of the registered Safety Compliance Facility applying for renewal;

8.11.1.4 The Annual Report provided pursuant to 16 Del.C. §4922A, confirms a continued need for the facility;

8.11.1.5 The applicant continues to meet all of the requirements for the operation of a Safety Compliance Facility as set forth in the Act and in these regulations; and

8.11.2 Suspension

8.11.2.1 The Department may suspend a registration certificate authorizing the operation of a Safety Compliance Facility for any violation of an applicable law or regulation.

8.11.3 Termination

8.11.3.1 Upon receipt of written notice that a registration certificate has been terminated, the Safety Compliance Facility has 30 business days to request, in writing, a hearing, for the purpose of review of such action. The hearing process shall follow the procedures in subsections 9.4 through 9.5.10 of these regulations:

8.11.3.1.1 A written decision will be issued by the Department within 30 days of the completion of the hearing. The decision will lift the suspension or terminate a registration certificate. The written decision will state with specificity the reasons for the decision; and

8.11.3.1.2 The termination of a registration certificate is a final decision of the Department, subject to judicial review. Jurisdiction and venue are vested in the Superior Court.

8.12 Non-transferable Registration Certificate Authorizing Operation of a Safety Compliance Facility

8.12.1 A registration certificate authorizing operation of a Safety Compliance Facility shall not be transferred by assignment or otherwise to other persons or locations. Unless the Safety Compliance Facility applies for and receives an amended registration certificate authorizing operation of a Safety Compliance Facility, the registration certificate shall be void and returned to the Department upon one or more of the following occurrences:

8.12.1.1 A change in ownership of the Safety Compliance Facility;

8.12.1.2 A change authorized physical location; or

8.12.1.3 The Safety Compliance Facility discontinues its operation.

8.12.2 A Safety Compliance Facility shall provide the Department with a written notice of any change described in subsection 8.12.1 of these regulations at least 60 days prior to the proposed effective date of the change. The Department may waive all or part of the required advance notice to address emergent or emergency situations.

8.12.3 Transactions which usually do not constitute a change of ownership include the following:

8.12.3.1 Changes in the membership of the board of directors or board of trustees; or

8.12.3.2 Two or more legal entities merge and the entity to whom the registration certificate authorizing operation of a Safety Compliance Facility was issued survives.

8.12.3.3 Management agreements are generally not considered a change in ownership if the entity to whom the registration certificate authorizing operation of a Safety Compliance Facility was issued continues to retain ultimate authority for the operation of the Safety Compliance Facility. However, if the ultimate authority is surrendered and transferred from the entity to whom the registration certificate authorizing operation of a Safety Compliance Facility was issued to a new manager, then a change of ownership has occurred.

8.13 Inspection

8.13.1 The Safety Compliance Facility will be available to State regulators for inspections, both scheduled and unscheduled, during normal business hours.

**History**
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *15 DE Reg. 1728 (06/01/12)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *15 DE Reg. 1728 (06/01/12)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*

##### **16 Del. Admin. Code § 4470-9.0** Monitoring and Corrective Actions {#sec-4470-9.0 omnilex-key=us-de-regs-official--title-16--4470-9.0}

9.1 On-site visits/interviews

9.1.1 The Department or its designee may perform on-site interviews of a qualified patient or designated caregiver to determine eligibility for the program. The Department may enter the premises of a qualified patient or designated caregiver during business hours for purposes of interviewing a program applicant. Twenty-four (24) hours’ notice will be provided to the qualified patient or designated caregiver prior to an on-site interview.

9.1.2 All qualified patients or designated caregivers shall provide the Department or the Department’s designee immediate access to any material and information necessary for determining eligibility with these requirements.

9.1.3 Failure by the qualified patient or designated caregiver to provide the Department access to the premises or information may result in action up to and including the revocation of the qualified patient or designated caregiver registry identification card and referral to state law enforcement.

9.1.4 Any failure to adhere to these rules, documented by the Department during an interview, may result in sanctions, including suspension, revocation, non-renewal or denial of licensure and referral to state or local law enforcement.

9.1.5 The Department shall refer credible criminal complaints against a qualified patient or designated caregiver to the appropriate state or local authorities.

9.2 Corrective action

9.2.1 If violations of these requirements are cited as a result of monitoring or police contact, the qualified patient or primary caregiver shall be provided with an official written report of the findings within 30 days following the monitoring visit.

9.2.2 Unless otherwise specified by the Department, the qualified patient or designated caregiver shall correct the violation within 5 calendar days of receipt of the official written report citing the violation.

9.2.3 The violation shall not be deemed corrected until the Department verifies in writing after receiving notice of the corrective action that the corrective action is satisfactory.

9.2.4 If the violation has not been corrected, the Department may issue a notice of contemplated action to revoke the qualified patient’s or designated caregiver’s registry identification card.

9.2.5 Suspension of registry identification card without prior hearing

9.2.5.1 In accordance with the 16 Del.C. Ch. 49A, if immediate action is required to protect the health and safety of the general public, the Department may suspend the qualified patient or designated caregiver registry identification card without notice.

9.2.5.1.1 A qualified patient or designated caregiver whose registry identification card has been summarily suspended may request a record review no later than 30 calendar days after the registry identification card was summarily suspended.

9.2.5.1.2 The record review requested subsequent to a summary suspension shall be conducted by the Department.

9.2.5.1.3 The Department shall conduct the record review on the summary suspension by reviewing all documents submitted by both card holder and the Department.

9.2.5.1.4 The sole issue at a record review on a summary suspension is whether the card holder’s registry identification card shall remain suspended pending a final adjudicatory hearing and ruling.

9.2.5.1.5 A card holder given notice of summary suspension by the Division may submit a written request to the Department for a record review. To be effective, the written request shall:

9.2.5.1.5.1 Be made within 30 calendar days, as determined by the postmark, from the date of the notice issued by the Department;

9.2.5.1.5.2 Be properly addressed to the medical marijuana program;

9.2.5.1.5.3 State the applicant’s name, address, and telephone numbers;

9.2.5.1.5.4 Provide a brief narrative rebutting the circumstances of the suspension; and

9.2.5.1.5.5 Additional documentation must be included with the request for a record review.

9.2.5.1.6 A card holder may request a hearing under subsection 9.4 following the record review.

9.3 Suspension, Revocation and Appeal Process

9.3.1 Participation in the medical marijuana program by a qualified patient or designated caregiver does not relieve the qualified patient or designated caregiver from:

9.3.1.1 Criminal prosecution or civil penalties for activities not authorized in this rule and act;

9.3.1.2 Liability for damages or criminal prosecution arising out of the operation of a vehicle while under the influence of marijuana; or

9.3.1.3 Criminal prosecution or civil penalty for possession, distribution or transfers of marijuana or use of marijuana:

9.3.1.3.1 In a school bus or public vehicle;

9.3.1.3.2 On school grounds or property;

9.3.1.3.3 In the workplace of the qualified patient's or designated caregiver's employment;

9.3.1.3.4 At a public park, recreation center, youth center or other public place;

9.3.1.3.5 To a person not approved by the Department pursuant to this rule;

9.3.1.3.6 Outside Delaware or attempts to obtain or transport marijuana from outside Delaware; or

9.3.1.3.7 That exceeds the allotted amount of usable medical use marijuana.

9.3.1.4 Criminal prosecution or civil penalties related to growing or cultivating marijuana.

9.3.2 Revocation of registry identification card

9.3.2.1 Violation of any provision of this rule may result in either the summary suspension of the qualified patient’s or designated caregiver’s registry identification card, or a notice of contemplated action to suspend or revoke the qualified patient’s or designated caregiver’s registry identification card, and all lawful privileges under the act.

9.3.3 Grounds for revocation or suspension of registry identification card, denial of renewal application for registry identification card.

9.3.3.1 A registry identification card may be revoked or suspended, and a renewal application may be denied for:

9.3.3.1.1 Failure to comply with any provisions of these requirements;

9.3.3.1.2 Failure to allow a monitoring visit by authorized representatives of the Department;

9.3.3.1.3 The discovery of repeated related criminal misconduct or criminal law violations of these requirements during monitoring visits.

9.4 Request for hearing

9.4.1 A qualified patient or designated caregiver whose registry identification card has been summarily suspended, or who has received a notice of contemplated action to suspend or revoke, may request a hearing for the purpose of review of such action. A cardholder whose card was summarily suspended and who requested a record review under subsection 9.2.5 may request a hearing following the record review. The request for hearing shall be filed within 30 calendar days of the date the action is taken, the notice of contemplated action is received, or the record review decision is received. The request shall include the following:

9.4.1.1 A statement of the facts relevant to the review of the action;

9.4.1.2 A statement of the provision of the act and the rules promulgated under the act that are relevant to the review of the action;

9.4.1.3 A statement of the arguments that the qualified patient/designated caregiver considers relevant to the review of the action; and

9.4.1.4 Any other evidence considered relevant.

9.5 Hearing procedure

9.5.1 As soon as possible, but in no event later than 60 calendar days after the request for hearing is received, the Department shall convene a hearing.

9.5.2 Notice of the hearing shall be issued in accordance with §10122 of Title 29.

9.5.2.1 There shall be no public notice of the hearing in accordance with §4920A of Title 16.

9.5.3 An individual may request an expedited hearing.

9.5.3.1 The Department shall schedule the hearing on an expedited basis provided that the Department receives the individual's written request for an expedited hearing within five (5) calendar days from the date on which the individual received notification of the Department's decision to suspend the individual’s card, or the date on which the individual received the final determination following the record review.

9.5.3.2 The Department shall convene an expedited hearing within 15 calendar days of the receipt by the Department of such a request.

9.5.3.3 The Department shall make a determination based upon the evidence presented.

9.5.3.4 A written copy of the determination and the reasons upon which it is based shall be sent to the individual within 30 calendar days.

9.5.4 Telephonic hearings

9.5.4.1 An individual cardholder may request a telephonic hearing at the time of the request for a hearing. Immediately after the parties agree to conduct the hearing by telephone, notice of the telephonic hearing shall be made to all parties and shall include all necessary telephone numbers.

9.5.4.2 Any party that has agreed to a telephonic hearing, but subsequently requests an in-person hearing shall do so in writing to the Department no later than 10 calendar days before the scheduled date of the hearing. The decision to grant or deny the request for an in-person hearing shall be at the discretion of the Department for good cause shown. The Department’s decision to grant or deny the hearing shall be issued in writing and shall include the specific reasons for granting or denying the request. Should the Department grant the request, the hearing shall be rescheduled to a time convenient for all parties. Should the Department deny the request, the telephonic hearing shall proceed as scheduled.

9.5.4.3 The location or locations of the parties during the hearing shall have a speaker telephone and technology available so that all shall hear the proceedings and documents shall be transmitted between witnesses and the Department.

9.5.4.4 Failure to provide the correct telephone number or failure to be available at the commencement of the hearing shall be treated as a failure to appear and shall subject the petitioner to a default judgment.

9.5.4.5 The in-person presence of some parties or witnesses at the hearing does not prevent the participation of other parties or witnesses by telephone with prior approval of the Department.

9.5.5 During an administrative hearing:

9.5.5.1 The individual has the right to be represented by counsel.

9.5.5.2 All statements made shall be under oath.

9.5.5.3 The individual has the right to examine and cross-examine witnesses.

9.5.5.4 The individual has the right to present evidence.

9.5.6 A stenographic recording will be made by a qualified court reporter. At the request and expense of any party, such record shall be transcribed with a copy to the other party.

9.5.7 Following the hearing, the Department shall make a determination based upon the evidence presented.

9.5.8 Upon reaching its conclusion of law and determining an appropriate disciplinary action, the Department shall issue a written decision and order in accordance with §10128 of Title 29.

9.5.9 All decisions of the Department shall be final and conclusive. Where the individual is in disagreement with the action of the Department, the individual may appeal the Department's decision to the Superior Court within 30 days of service or of the postmarked date of the copy of the decision mailed to the individual. The appeal shall be on the record to the Superior Court and shall be as provided in §§10142 - 10145 of Title 29.

9.5.10 A written copy of the determination and the reasons upon which it is based shall be sent to the patient or caregiver cardholder within 30 calendar days.

**History**
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *15 DE Reg. 1728 (06/01/12)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *15 DE Reg. 1728 (06/01/12)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*

##### **16 Del. Admin. Code § 4470-10.0** General Provisions for the Production of Edible Marijuana Products {#sec-4470-10.0 omnilex-key=us-de-regs-official--title-16--4470-10.0}

10.1 Delaware Department of Health and Social Services adopts these regulations pursuant to the authority vested by 16 Del.C. §122. These regulations establish registration procedures and standards of practice for conducting marijuana infused food processing operations in Compassion Center kitchens that safeguard public health and provide to consumers food that is tested for safety, potency and consistency. A marijuana infused food establishment that prepares, sells or dispenses edible marijuana products must:

10.1.1 Before preparing, selling or dispensing an edible marijuana product, obtain written authorization from the Division to prepare, sell or dispense edible marijuana products; and

10.1.2 If the marijuana business prepares edible marijuana products, ensure that the edible marijuana products are prepared according to the applicable requirements set forth in these regulations.

10.2 Each compassion center and facility for the production of edible marijuana products or marijuana-infused products shall, in consultation with the Division, cooperate to ensure that all edible marijuana products and marijuana-infused products offered for sale:

10.2.1 Are labeled clearly and unambiguously as medical marijuana;

10.2.2 Are not presented in packaging that is appealing to children. These requirements include:

10.2.2.1 Tamper or child-resistant packaging;

10.2.2.2 Opaque or plain in design;

10.2.2.3 Resealable for any product intended for more than a single use;

10.2.2.4 Prohibited from using bright colors, defined as colors that are “neon” in appearance;

10.2.2.5 Prohibited from imitating or having a semblance to any existing branded consumer products, including foods, beverages and toys;

10.2.2.6 Prohibited from using cartoons, cartoon-like font, caricatures, fruit, human or animal shapes, pictures/photographs images, or picture/photographs of product;

10.2.2.7 Prohibited from featuring a design, symbol, or celebrity brand or name that resembles a non-cannabis consumer product;

10.2.2.8 Prohibited from featuring images of minors or words that refer to products that are commonly associated with minors or marketed to minors; and

10.2.2.9 Each single serving of an edible contained in multiple serving package small be marked, stamped or otherwise imprinted with the following symbol:

10.2.3 Are regulated and sold on the basis of the concentration of THC and/or CBD in the products and not by weight; and

10.2.4 Are packaged and labeled in such a manner as to allow tracking by DEC3S.

10.3 Labeling

10.3.1 Products shall be properly labeled with the following: Name of Compassion Center, phone and website of compassion center that produced the edible, name of product, net weight, date of production / lot number, barcode, refrigeration of the product if required and cannabinoid profile.

10.3.2 Labels shall include a list of ingredients in decreasing order by weight, serving size and how many servings per package, batch, serial number and barcodes.

10.3.3 Labels shall include the following statement: “This food is made in a Marijuana Infused Food Establishment and is NOT subject to routine Government Food Safety Inspections” with a seal stating “tested for contaminants”.

10.3.4 Labels shall be printed in at least 6-point type, as long as the information can be easily read using standard reading glasses, in a color that provides a clear contrast to the background label.

10.3.5 Additional information as required by the Division must be made available for review upon request from the consumer, including the following:

10.3.5.1 The date on which the product was manufactured;

10.3.5.2 If the product is perishable, a suggested use-by date;

10.3.5.3 The total milligrams of active cannabinoids and terpenoids in the product, as provided by the independent testing laboratory that tested the product;

10.3.5.4 A list of all ingredients including amount in grams of sodium, sugar, carbohydrates and total fat per serving and all major food allergens as identified in 21 U.S.C. §§343;

10.3.5.5 A warning that states: “Caution: When eaten or swallowed, the intoxicating effects of this drug may be delayed by 2 or more hours.”

10.3.5.6 If a marijuana extract was added to the product, a disclosure of the type of extraction process and any solvent, gas or other chemical used in the extraction process, or any other compound added to the extract;

10.3.5.7 A warning that states: “This product may have intoxicating effects and may be habit forming.”

10.3.5.8 The statement: “This product is unlawful outside of the State of Delaware.”

10.3.5.9 A medical marijuana dispensary must provide with all edible marijuana products and marijuana-infused products sold at retail accompanying material that discloses any products applied to the marijuana plants and growing medium during production of the marijuana used to create the extract added to the edible marijuana products or marijuana-infused products and the type of extraction method used, including, without limitation, any solvents, gases or other chemicals or compounds used to produce or that are added to the extract, and contains the following warnings:

10.3.5.9.1 “The impairment effects of edible products may be delayed by two hours or more. This product has not been analyzed or approved by the FDA to treat, cure, or prevent any disease. There is limited information on the side effects of using this product, and there may be associated health risks.

10.3.5.9.2 “This product contains or is infused with marijuana or active compounds of marijuana.”;

10.3.5.9.3 “This product should not be used by women who are pregnant or breast feeding.”

10.3.5.9.4 “For use only by the person named on the label of the dispensed product. Keep out of the reach of children.”

10.3.5.9.5 “Products containing marijuana can impair concentration, coordination and judgment. It is against the law drive or operate a vehicle or machinery under the influence of this product.”

10.3.5.9.6 “FOR USE BY ADULTS 18 and OLDER, KEEP THIS PRODUCT AWAY FROM CHILDREN.”

10.4 Packaging

10.4.1 The immediate food contact surface of any product packaging material shall be food grade in quality, and therefore meet the food safety requirements of 16 Del.C. Ch. 33.

10.4.2 Any product containing marijuana must be packaged in child-resistant packaging in accordance with 16 C.F.R. §1700.

10.4.3 Marijuana-infused products must be packaged in plastic which is 4 millimeters or more in thickness and must be heat-sealed without an easy-open tab, dimple, and corner or flap so that it is difficult for a child to open and as a tamperproof measure.

10.4.4 Any container or packaging containing usable marijuana, edible marijuana products or marijuana-infused products must protect the contents from contamination and must not impart any toxic or deleterious substance to the usable marijuana or marijuana product.

10.5 Exemptions

10.5.1 Establishments registered as marijuana infused food establishments in Delaware shall be exempt from the Cottage Food Regulations.

10.5.2 Establishments registered under these regulations shall be exempt from the State of Delaware Food Code, 16 DE Admin. Code 4458.

10.6 Inspections

10.6.1 The Division may conduct one or more preoperational inspections to verify that the marijuana infused food establishment is:

10.6.1.1 Constructed and equipped in accordance with the registration application;

10.6.1.2 Has established standard operating procedures as specified; and

10.6.1.3 Is otherwise in substantial compliance with these regulations.

10.6.2 Additional inspections both scheduled and no-notice will be conducted at the discretion of the Division and as deemed necessary by the Division.

**History**
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *15 DE Reg. 1728 (06/01/12)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *15 DE Reg. 1728 (06/01/12)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*

##### **16 Del. Admin. Code § 4470-11.0** Limitations {#sec-4470-11.0 omnilex-key=us-de-regs-official--title-16--4470-11.0}

11.1 Registration

11.1.1 Marijuana Infused Food Establishments are only permitted to engage in direct sales with consumers in the State of Delaware.

11.1.2 Online sales are not permitted. Online advertising and marketing are permitted subject to the limitations listed in 16 Del.C. Ch. 49A.

11.1.3 Wholesale or other sales to resellers or food establishments are not permitted by a Marijuana Infused Food Establishment.

11.1.4 A Marijuana Infused Food Establishment shall only produce those specific food products listed on their registration.

11.1.5 Approved sources of non-marijuana ingredients:

11.1.5.1 Each facility for the production of edible marijuana products or marijuana-infused products shall ensure that it obtains non-marijuana ingredients for edible marijuana products or marijuana-infused products from sources that comply with the requirements of federal and state law and regulations and are approved by the Division, including, without limitation, commercial and retail businesses.

11.1.6 The production of edible marijuana products or marijuana-infused products for sale shall not use non-marijuana ingredients prepared or stored in a private home.

11.2 Allowable Products

11.2.1 Products produced in a Marijuana Infused Food Establishment are limited to non-TCS baked goods and candy.

11.2.2 The manufacturing of baked goods shall be allowed in a Marijuana Infused Food Establishment to include cookies, muffins and brownies.

11.2.3 Bakery items which as a finished product contain components such as fruit filling, cream filling or meat are prohibited.

11.2.4 Candy products including, but not limited to chewables, fudge, lollipops, chocolates, and hard candy, are allowed to be manufactured in a Marijuana Infused Food Establishment provided the final products are non-TCS.

11.2.5 All labeling requirements set forth in subsection 16.2 must be met before the product is sold.

11.2.6 Products may not exceed 10mg of THC-Delta 9 or 25mg of CBD per serving.

11.2.7 Marijuana infused products are limited to five servings per package.

11.2.8 Products infused with THC, must have the letters “THC” molded into the product.

11.3 Application

11.3.1 Compassion Centers seeking registration as a Marijuana Infused Food Establishment must submit to the Division an application demonstrating that they meet the requirements set forth in these regulations. The application shall include:

11.3.1.1 The name, mailing address, e-mail address, telephone, and signature of the person applying for the registration and the name, mailing address, and physical address of the Marijuana Infused Food Establishment;

11.3.1.2 Information about products and processes including but not limited to products to be made, ingredients, example labels, processes and products;

11.3.1.3 Floor plan of the processing area identifying appliances to be used, food contact surfaces (types of materials used for contact surfaces must be described,) areas for refrigeration and dry good storage, and restroom facilities;

11.3.1.4 Proof of completion of training that satisfies Section 13.0; and

11.3.1.5 A statement signed by the applicant that:

11.3.1.5.1 Attests to the accuracy of the information provided in the application;

11.3.1.5.2 Affirms that the applicant will comply with these regulations; and

11.3.1.5.3 Allow the Division access to the establishment as specified under subsection 10.6 and to the records specified under subsection 7.5.

11.3.2 Compassion Centers may first apply to the Division for an endorsement as a Marijuana Infused Food Establishment on or after July 1, 2020.

11.3.3 Following the submission of an application demonstrating that all requirements of these regulations have been met, up to and including the on-site inspection, the producer may begin sales to consumers in accordance with these regulations.

11.3.4 Upon registration by the Division, a Marijuana Infused Food Establishment and associated activities shall comply with the standards established by these regulations.

11.3.5 It shall be a violation of these regulations to operate in Delaware as a Marijuana Infused Food Establishment, as defined by these regulations, if not registered with the Division.

11.3.6 Registration with the Division does not exempt the Marijuana Infused Food Establishment from other state, county or local codes unless specifically listed in subsection 10.5.

11.3.7 If the proposed Marijuana Infused Food Establishment uses a private well as a source of potable water, the well must be in compliance with State of Delaware Regulations Governing Public Drinking Water, 16 DE Admin. Code 4462.

11.3.7.1 Private wells shall comply with chemical and bacteriological standards; a satisfactory analysis is required before a registration may be issued. Completion of any required sampling is the responsibility of the Compassion Centers.

11.3.7.2 Tests conducted within 60 days of the date of the initial or renewal application will be accepted to demonstrate compliance.

11.3.8 Establishments served by a public water supply and sewage systems do not require further evaluation.

11.4 Renewal

11.4.1 Registration must be renewed bi-annually.

11.4.1.1 Marijuana Infused Food Establishments must maintain a Medical Marijuana Compassion Center License through the Division.

**History**
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *15 DE Reg. 1728 (06/01/12)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *15 DE Reg. 1728 (06/01/12)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*

##### **16 Del. Admin. Code § 4470-12.0** Marijuana Infused Food Establishment Endorsement Requirements {#sec-4470-12.0 omnilex-key=us-de-regs-official--title-16--4470-12.0}

12.1 Conditions of the Marijuana Infused Food Establishment Endorsement

12.1.1 Upon acceptance of the endorsement to operate a Marijuana Infused Food Establishment issued by the Division the Compassion Center shall:

12.1.1.1 Allow representatives of the Division access to the Marijuana Infused Food Establishment during hours of operation and other reasonable times. After the Division representative presents official credentials and an intent to conduct an inspection the producer shall allow the Division representative to determine if the Marijuana Infused Food Establishment is in compliance with these regulations by allowing access to the establishment, allowing inspection, and providing information and records to which the Division is entitled according to law;

12.1.1.2 Comply with Division directives including time frames for corrective actions specified in inspection reports and other directives issued by the Division regarding the Marijuana Infused Food Establishment. Comply with the conditions of a granted variance, and conditions of approved facility plans and specifications;

12.1.1.3 Accept notices issued and served by the Division according to the law. Be subject to the administrative, civil, injunctive, and criminal remedies authorized in law for failure to comply with the regulations or Division directives, including time frames for corrective actions specified in inspection reports;

12.1.1.4 Immediately discontinue operations and notify the Division if an imminent health hazard may exist because of an emergency such as fire, flood, extended interruption of electrical or water service, sewage backup, misuse of poisonous or toxic materials, onset of an apparent foodborne illness outbreak, gross unsanitary occurrence or condition, or other circumstance that may endanger health;

12.1.1.5 Immediately contact the Division to report an illness of an employee who is diagnosed with Norovirus, Salmonella typhi (Typhoid fever), Shigella spp., Shiga toxin-producing E. Coli including 0157:H7, Hepatitis A virus or nontyphoidal salmonella;

12.1.1.6 Replace existing facilities and equipment with facilities and equipment that comply with the Code if:

12.1.1.6.1 The Division directs the replacement because the surfaces and equipment constitute a public health hazard or nuisance or no longer comply with the criteria upon which the surfaces and equipment were accepted; or

12.1.1.6.2 The Division directs the replacement of the facilities and equipment because of a change of ownership.

12.1.1.7 Prepare and maintain a current written contingency plan for use in initiating and affecting a product recall.

12.2 Safe Production of Marijuana Infused Products

12.2.1 Each facility for the production of edible marijuana products or marijuana-infused products shall ensure that:

12.2.1.1 Pasteurized eggs or egg products are substituted for raw eggs in the preparation of edible marijuana products or marijuana-infused products.

12.2.1.2 Marijuana products and ingredients only have contact with the surfaces of:

12.2.1.2.1 Equipment and utensils that are cleaned and sanitized; or

12.2.1.2.2 Single-service and single-use articles that have not previously been used.

12.2.1.3 All ingredients must be cooked thoroughly to a safe temperature for the proper time.

12.3 Quality Control Unit

12.3.1 Each facility for the production of edible marijuana products or marijuana-infused products shall have a quality control unit that:

12.3.1.1 Has the responsibility and authority to approve or reject all components, product containers, closures, in-process materials, packaging materials, labeling and marijuana or marijuana products;

12.3.1.2 Has the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated and resolved;

12.3.1.3 Is responsible for approving or rejecting marijuana or marijuana products manufactured, processed, packaged or held under contract by another Compassion Center;

12.3.1.4 Is responsible for approving or rejecting all procedures or specifications which may impact the identity, strength, quality and purity of the marijuana or marijuana products.

12.3.2 Each Compassion Center or Marijuana Infused Food Establishment shall:

12.3.2.1 Set forth the responsibilities and procedures applicable to the quality control unit in writing; and

12.3.2.2 Follow the written responsibilities and procedures set forth pursuant to subsection 7.3.12.3.

**History**
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *15 DE Reg. 1728 (06/01/12)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *15 DE Reg. 1728 (06/01/12)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*

##### **16 Del. Admin. Code § 4470-13.0** Training Requirements {#sec-4470-13.0 omnilex-key=us-de-regs-official--title-16--4470-13.0}

At least one employee during hours of operation shall be on location and have shown proficiency in food safety through passing a test that is part of a program approved by the Office of Food Protection.

**History**
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *15 DE Reg. 1728 (06/01/12)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *15 DE Reg. 1728 (06/01/12)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*

##### **16 Del. Admin. Code § 4470-14.0** Producer Requirements {#sec-4470-14.0 omnilex-key=us-de-regs-official--title-16--4470-14.0}

14.1 The producer shall ensure that:

14.1.1 Only approved food items shall be made in the Marijuana Infused Food Establishment;

14.1.2 Only persons necessary to the Marijuana Infused Food Establishment shall be allowed in the food preparation, food storage or ware washing areas during operation;

14.1.3 Producers and employees are effectively cleaning their hands, by routinely hand washing per specifications provided by the Division;

14.1.4 Producers or employees are properly cooking TCS ingredients, being particularly careful in cooking those foods known to cause severe foodborne illness and death, and routinely monitor cooking temperatures using appropriate temperature measuring devices properly scaled and calibrated;

14.1.5 Producers or employees are properly sanitizing cleaned multiuse equipment and utensils before they are reused, through routine monitoring of solution temperature and exposure time for hot water sanitizing, and chemical concentration, pH, temperature, and exposure time for chemical sanitizing per specifications provided by the Division;

14.1.6 Producers and employees shall prevent cross-contamination of ready to eat food with bare hands by properly using suitable utensils such as deli tissue, spatulas, tongs, single use gloves, or dispensing equipment; and

14.1.7 Producers and employees are informed in a verifiable manner of their responsibility to report to the producer, information about their health and activities as they relate to diseases that are transmissible through food.

**History**
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *15 DE Reg. 1728 (06/01/12)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *15 DE Reg. 1728 (06/01/12)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*

##### **16 Del. Admin. Code § 4470-15.0** Facility Requirements {#sec-4470-15.0 omnilex-key=us-de-regs-official--title-16--4470-15.0}

15.1 Indoor Areas

15.1.1 Materials that are smooth, durable and easily cleanable shall be installed in the following areas:

15.1.1.1 Food preparation

15.1.1.1.1 Each facility for the production of edible marijuana products or marijuana-infused products shall ensure that:

15.1.1.1.1.1 The surfaces of equipment and utensils that have direct contact with marijuana products are clean to sight and touch;

15.1.1.1.1.2 The surfaces of cooking equipment and pans that have direct contact with marijuana products are kept free of encrusted grease deposits and other soil accumulations;

15.1.1.1.1.3 The surfaces of equipment that do not have direct contact with marijuana products are kept free of an accumulation of dust, dirt, residue and other debris.

15.1.1.2 Food preparation area surfaces

15.1.1.2.1 Each facility for the production of edible marijuana products or marijuana-infused products shall ensure that the surfaces of equipment and utensils that have direct contact with marijuana products are cleaned:

15.1.1.2.1.1 Each time there is a change from working with raw marijuana products to working with finished marijuana products;

15.1.1.2.1.2 Between uses with potentially hazardous marijuana products and ingredients, using the appropriate time and temperature controls to ensure the safety of the marijuana products;

15.1.1.2.1.3 At any time during operation when contamination may have occurred;

15.1.1.2.1.4 If they come into contact with potentially hazardous marijuana products or ingredients, surfaces and utensils are cleaned throughout the day at least once every 4 hours.

15.1.1.2.1.5 The surfaces of utensils and equipment that have direct contact with marijuana products or ingredients that are not potentially hazardous are cleaned:

15.1.1.2.1.5.1 At any time when contamination may have occurred;

15.1.1.2.1.5.2 At a frequency specified by the manufacturer; or

15.1.1.2.1.5.3 If the manufacturer does not specify a frequency, at a frequency necessary to prevent the accumulation of soil or mold.

15.1.1.3 Dry food storage

15.1.1.3.1 All elements involved in the production of marijuana infused products will be stored at least 12 inches off the floor on shelving or other generally recognized food storage container.

15.1.2 Carpeting of any kind, shall not be used in the following areas:

15.1.2.1 Food preparation; or

15.1.2.2 Dry food storage.

15.1.3 Utility lines shall be installed inside walls, above ceiling or below floors, where possible.

15.1.4 Insect control devices shall not be installed over food preparation surfaces.

15.2 Artificial Interior Lighting

15.2.1 Provide minimum illumination intensities

15.2.1.1 At least 50-foot candles at a surface where a producer or employee is working with food or working with utensils or equipment such as knives, slicers, and grinders or where the producer or employee safety is a factor.

15.3 Animals

15.3.1 No animals/pets shall be permitted in the kitchen area of a Marijuana Infused Food Establishment during the preparation, packaging, or handling of any marijuana infused food products. Employees with service animals, as defined by the Americans with Disabilities Act, must comply with state and federal food codes regarding the presence of service animals in food establishments.

15.4 Poisonous and Toxic Materials

15.4.1 Toxic substances shall be stored so they cannot contaminate food preparation or cooking equipment in kitchen areas.

15.4.2 Rodent bait shall be contained in covered, tamper-resistant bait stations. Toxic tracking powders shall not be used as a pesticide and nontoxic tracking powders shall not contaminate food, equipment or utensils.

15.4.3 All medicines and first aid supplies shall be labeled and stored in a kit or container out of food preparation areas.

15.5 Plumbing in a Marijuana Business

15.5.1 The plumbing shall meet the requirements of all municipal, county or state codes.

15.5.2 Marijuana Infused Food Establishments shall have convenient access to permanent restroom facilities equipped with running potable water, paper towels and soap.

15.6 Sewage Disposal

15.6.1 Individual sewage disposal systems require the approval of the Department of Natural Resources and Environmental Control prior to operating the establishment.

15.7 Temperature Measuring Devices (TMD)

15.7.1 In mechanically refrigerated food storage units, TMD shall be located to measure the air temperature in the warmest part of the unit.

15.7.2 TMD shall be readily accessible for use in ensuring attainment and maintenance of required food temperatures.

15.7.3 TMD shall be accurate to ±1o Celsius or ±2o Fahrenheit to measure food temperatures.

15.7.4 TMD shall not have sensors constructed of glass, except if encased in shatterproof coating.

15.8 Refrigeration and Cold Holding Equipment

15.8.1 Freezer units shall be capable of maintaining stored food solidly frozen.

15.8.2 Refrigeration and cold holding units shall be capable of maintaining stored foods at 41o Fahrenheit or below.

**History**
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *15 DE Reg. 1728 (06/01/12)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *15 DE Reg. 1728 (06/01/12)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*

##### **16 Del. Admin. Code § 4470-16.0** Product Requirements {#sec-4470-16.0 omnilex-key=us-de-regs-official--title-16--4470-16.0}

16.1 Testing

16.1.1 All batches of food are required by the Division to be laboratory tested through the Safety Compliance Facility for safety and cannabinoid profile. Testing of food products shall be the financial responsibility of the Compassion Center.

16.2 Recall Plan

16.2.1 The Marijuana Infused Food Establishment shall:

16.2.1.1 Prepare and maintain a current written contingency plan for use in initiating and affecting a recall of products;

16.2.1.2 Use sufficient coding of regulated products to make possible positive identification and to facilitate effective recall of all violated lots;

16.2.1.3 Maintain such product distribution records as are necessary to facilitate location of products that are being recalled. Such records shall be maintained for 3 years.

16.3 Reporting and Records

16.3.1 A Marijuana Infused Food Establishment must maintain records for each batch of product indicating type of finished product, date of production, lot number, and date and location of sales. These records shall be maintained for 3 years.

**History**
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *15 DE Reg. 1728 (06/01/12)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *15 DE Reg. 1728 (06/01/12)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*

##### **16 Del. Admin. Code § 4470-17.0** Compliance and Enforcement Procedures {#sec-4470-17.0 omnilex-key=us-de-regs-official--title-16--4470-17.0}

17.1 A person may not operate a Marijuana Infused Food Establishment without a valid endorsement to operate issued by the Division.

17.2 If the Division determines that a Marijuana Infused Food Establishment is operating without a valid endorsement; that one or more conditions exist which represent an imminent health hazard; or that serious violations, repeat violations, or general unsanitary conditions are found to exist, administrative action may occur.

17.2.1 Administrative action on the Marijuana Infused Food Establishment will be conducted in accordance with the following:

17.2.1.1 Operation without an endorsement

17.2.1.1.1 Immediate Closure Order

17.2.1.1.1.1 If a Marijuana Infused Food Establishment is found operating without an endorsement as required by subsection 7.1 of this regulation, the Division shall order the establishment immediately closed.

17.2.1.1.2 Notice of Closure

17.2.1.1.2.1 The closure shall be effective upon receipt of a written notice by the producer or employee of the Marijuana Infused Food Establishment. A closure notice statement recorded on the inspection report by a representative of the Division constitutes written notice.

17.2.1.1.3 Duration of Closure

17.2.1.1.3.1 The Marijuana Infused Food Establishment shall remain closed until an endorsement application; applicable fees and any required plans have been received and approved by the Division.

17.2.1.2 Imminent Health Hazards

17.2.1.2.1 Endorsement suspension without hearing

17.2.1.2.1.1 If some condition is determined to exist in a Marijuana Infused Food Establishment which presents an imminent health hazard to the public, or for any violation of an applicable law or regulation, the Division may suspend the endorsement of the Marijuana Infused Food Establishment without a prior hearing. The suspension shall be effective upon receipt of written notice by the producer or employee of the marijuana establishment. A suspension statement recorded on an inspection report by the Division constitutes written notice.

17.2.1.3 Serious Violations, Repeat Violations and General Unsanitary Conditions

17.2.1.3.1 When conditions exist in a marijuana establishment that represent serious violations, repeat violations or general unsanitary conditions, the Division may initiate a corrective action plan.

17.2.2 In response to the order to close, the facility may:

17.2.2.1 Take no action, in which case the order to close shall remain in effect.

17.2.2.1.1 Take action to correct the unsafe and unsanitary practices identified during the survey.

17.2.2.1.1.1 The facility may submit evidence through a written plan of correction showing that the deficient practices, identified during the investigation, have been addressed and corrected.

17.2.2.1.1.2 A change of location for the facility does not nullify an order to close and an acceptable plan of correction must still be submitted.

17.2.2.1.1.3 The Department shall determine if the plan of correction is acceptable.

17.2.2.1.1.4 Once accepted, the Department shall schedule a revisit as soon as possible.

17.2.2.2 Request, in writing, an administrative hearing with the Department to contest the order to close.

17.2.2.2.1 Such request must be received within 10 calendar days from the date on which the order to close was issued.

17.2.2.2.1.1 As soon as possible, but in no event later than 60 calendar days after the issuance of the closure order, the Department shall convene a hearing on the reasons for closure.

17.2.2.2.1.2 The Department shall make a determination based upon the evidence presented.

17.2.2.2.1.2.1 A written copy of the determination and the reasons upon which it is based shall be sent to the facility within 30 calendar days of the hearing.

17.2.2.2.2 During an administrative hearing:

17.2.2.2.2.1 The facility has the right to be represented by counsel;

17.2.2.2.2.2 All statements made shall be under oath;

17.2.2.2.2.3 The facility has the right to examine and cross-examine witnesses and present evidence;

17.2.2.2.2.4 A stenographic record will be made by a qualified court reporter. At the request and expense of any party, such record shall be transcribed with a copy to the other party; and

17.2.2.2.2.5 The decision of the Department shall be based upon sufficient legal evidence. If the charges are supported by such evidence, the Department may continue, modify or revoke the closure order.

17.2.2.2.3 Upon reaching its conclusion of law and determining an appropriate disciplinary action, the Department shall issue a written decision and order in accordance with §10128 of Title 29.

17.2.2.2.4 All decisions of the Department shall be final and conclusive. Where the facility is in disagreement with the action of the Department, the facility may appeal the Department's decision to the Superior Court within 30 days of service or of the postmarked date of the copy of the decision mailed to the facility. The appeal shall be on the record to the Superior Court and shall be as provided in §§10142 - 10145 of Title 29.

17.2.3 Examination of Food

17.2.3.1 Food may be examined or tested by the Division contract lab as often as necessary for enforcement of this regulation.

17.2.3.2 All food shall be wholesome and free from spoilage. Food that is spoiled or unfit for human consumption shall not be kept on the premises.

17.3 Penalties

17.3.1 Operation in Violation of Regulation

17.3.1.1 Any person who violates a provision of this regulation, and any person who is the holder of a permit or who otherwise operates a food establishment that does not comply with the requirements of this regulation shall be subject to the penalties found in 16 Del.C. §4914 and these regulations.

17.4 Injunction

17.4.1 The Division may seek to enjoin violations of the regulation.

**History**
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *15 DE Reg. 1728 (06/01/12)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *15 DE Reg. 1728 (06/01/12)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*

##### **16 Del. Admin. Code § 4470-18.0** Random Sampling Procedures {#sec-4470-18.0 omnilex-key=us-de-regs-official--title-16--4470-18.0}

18.1 Compassion Centers will coordinate with the Office of Medical Marijuana (OMM) for collection of samples by State Regulators, who will supervise randomly chosen samples of each batch for testing by the Testing Center. Sample results will be loaded into the DEC3S system by the testing center allowing Compassion Centers to sell the material or incorporate it into other products.

18.2 Sampling

18.2.1 Compassion centers may create any size batch they deem appropriate, but not more than five (5) pounds.

18.2.2 The minimum sample size is set at 0.5% of batch weight. A one (1) pound batch would require a two (2) gram sample and a five (5) pound batch would require an 11-gram sample. The minimum sample size for testing is one (1) gram.

18.2.3 All medical marijuana products will be tested as directed in subsection 18.3 of these regulations.

18.3 Compassion Center’s Responsibility:

18.3.1 Compassion Centers will coordinate harvest schedules with the Office of Medical Marijuana (OMM) and the Testing Center.

18.3.1.1 After the marijuana has been harvested, dried and cured, the OMM staff will supervise selection of random samples from the curing vessels with the Compassion Center staff.

18.3.1.2 Compassion Center staff will prepare additional barcode labels and tamper-proof containers for each batch and develop a transportation manifest, initiating the chain of custody process for the batch of plants being tested.

18.3.2 The Compassion Centers will not sell or prepare products from the batch being tested until the testing centers enter the values into the DEC3S program, releasing the material for use or sale.

18.3.3 Compassion Centers will be invoiced for payment of testing services directly from the Testing Center.

18.3.4 All concentrates or other infused products must be sent to the Testing Center using the process listed above before they are cleared for sale.

18.4 Testing Facility Responsibility:

18.4.1 The testing center will receive samples from the Office of Medical Marijuana (OMM) staff and co-sign the sample manifest after verification of sample barcodes. The testing center will enter the samples into the lab portion of DEC3S. The Testing Center will process the samples for the following profile, terpenes and contaminates:

18.4.1.1 Tetrahydrocannabinol (THC).

18.4.1.2 Tetrahydrocannabinolic Acid (THCA).

18.4.1.3 Cannabidiol (CBD).

18.4.1.4 Cannabidiolic Acid (CBDA).

18.4.1.5 Cannabigerol (CBG).

18.4.1.6 Cannabinol (CBN).

18.4.1.7 That the presence of contaminants does not exceed the levels in the most current version of the American Herbal Pharmacopoeia Monograph or the guidance from the Division of Public Health.

18.4.2 Contaminants include, but are not limited to, all of the following:

18.4.2.1 Residual solvent or processing chemicals.

18.4.2.2 Foreign material, including, but not limited to, hair, insects, or similar or related adulterant.

18.4.2.3 Microbiological impurity, including total aerobic microbial count, total yeast mold count, P. aeruginosa, aspergillus spp., s. aureus, aflatoxin B1, B2, G1, G2, or ochratoxin A, E. coli, and coliforms.

18.4.2.4 Residual levels of volatile organic compounds shall be below the lesser of either the specifications set by the United States Pharmacopeia (U.S.P. Chapter 467) or those set by the Division of Public Health.

18.4.3 Terpenes described in the most current version of the cannabis inflorescence monograph published by the American Herbal Pharmacopoeia. Terpene testing will be done as required by the compassion centers to inform patients of the products formulization.

18.4.4 After the sample testing has been completed,

18.4.4.1 Testing Center will update DEC3S with the values associated with the tests. If the samples pass all tests, the barcode is unlocked, and Compassion Centers will able to sell or use the marijuana in making other products or concentrates.

18.4.4.2 Testing Center will certify destruction of the sample after DEC3S is updated.

18.5 Delaware Consolidated Cannabis Control System (DEC3S) Actions:

18.5.1 The Delaware Consolidated Cannabis Control System (DEC3S) will be used throughout the sample collection, manifest and barcode verification procedures.

18.5.2 Batches will be listed as unavailable for sale until the Testing Center completes the sample testing and enters the results into DEC3S, unlocking them for sale.

18.5.3 The cannabinoid profile values will be available for the Compassion Centers to list on the packaging of the medical marijuana product.

18.5.4 If a sample tested fails one or more of the listed standards, the DEC3S will lockout those barcodes until remediation action is completed and the batch is resubmitted for testing.

18.5.4.1 If remediation is not possible, the compassion center will coordinate with the Office of Medical Marijuana on the batches disposition or the batch must be scheduled for destruction.

**History**
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *15 DE Reg. 1728 (06/01/12)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *15 DE Reg. 1728 (06/01/12)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*

##### **16 Del. Admin. Code § 4470-19.0** Severability {#sec-4470-19.0 omnilex-key=us-de-regs-official--title-16--4470-19.0}

In the event any particular clause or section of these regulations should be declared invalid or unconstitutional by any court of competent jurisdiction, the remaining portions shall remain in full effect.

**History**
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *15 DE Reg. 1728 (06/01/12)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *15 DE Reg. 1728 (06/01/12)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*

##### **16 Del. Admin. Code § 4470-20.0** Variance {#sec-4470-20.0 omnilex-key=us-de-regs-official--title-16--4470-20.0}

20.1 A licensee may seek a variance from these regulations by making a request for variance to the Division. The Division may grant a variance by modifying or waiving the requirements of these regulations if, in the opinion of the Division, a health hazard or nuisance will not result from the variance

20.2 A variance shall not be transferable from person to person, nor from location to location.

20.3 If a variance is granted, the Division shall retain the information specified below in its records for the variance:

20.3.1 A statement of the proposed variance of the requirement of these regulations, citing the relevant section of these regulations;

20.3.2 An analysis of the rationale for how the potential public health hazards or nuisances will be alternatively addressed by the proposal; and

20.3.3 Any other information requested by the Division that may be deemed necessary to render judgment.

20.4 A variance is rendered void upon occurrence of one or more of the following: the physical facility is demolished; a remodeling project in the facility includes the areas addressed in the variance.

**History**
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *15 DE Reg. 1728 (06/01/12)*
- *17 DE Reg. 738 (01/01/14)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*
- *23 DE Reg. 667 (02/01/20)*
- *15 DE Reg. 1728 (06/01/12)*
- *17 DE Reg. 738 (01/01/14)*
- *19 DE Reg. 409 (11/01/15)*
- *23 DE Reg. 667 (02/01/20)*
- *24 DE Reg. 485 (11/01/20)*

#### **4500** Office of Animal Welfare

#### **4501** Regulations For Animals Held in Shelter

##### **16 Del. Admin. Code § 4501-1.0** Authority and Purpose {#sec-4501-1.0 omnilex-key=us-de-regs-official--title-16--4501-1.0}

1.1 These regulations are promulgated by the Delaware Department of Health and Social Services pursuant to 16 Del.C. §§3004F(d) and 3008F(a) pertaining to animal shelter standards and shall apply to any animal shelter as defined in Section 2.0.

1.2 The overall purpose of these regulations is to promote and ensure the protection and care of animals in animal shelters and to increase opportunities for their placement and adoption. They also establish requirements for humane euthanasia of animals held in animal shelters.

1.3 These regulations define:

1.3.1 Training and certification requirements for certified euthanasia technicians;

1.3.2 Minimum standards of care and treatment;

1.3.3 Requirements for adoption and recovery;

1.3.4 Acceptable standards, methods and procedures of euthanasia;

1.3.5 Record keeping obligations; and

1.3.6 Procedures for inspections and complaints.

**History**
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *18 DE Reg. 866 (05/01/15)*
- *27 DE Reg. 530 (01/01/24)*

##### **16 Del. Admin. Code § 4501-2.0** Definitions {#sec-4501-2.0 omnilex-key=us-de-regs-official--title-16--4501-2.0}

The following words or terms, when used in these regulations, shall have the meaning indicated, unless the context otherwise requires:

"Adoption" means the permanent transfer of ownership/guardianship of a companion animal from a shelter to a new owner/guardian.

"Animal shelter" means a public or private facility which includes a physical structure that provides temporary or permanent shelter to stray, abandoned, abused, or owner-surrendered animals and that is operated, owned, or maintained by a duly incorporated humane society, animal welfare society, or other nonprofit organization for the purpose of providing for and promoting the welfare, protection, and humane treatment of animals. "Animal shelter" shall not include individuals providing temporary foster care to animals in their home or to animal rescue groups sheltering animals on an individual's private property.

"Applicant" means a person that has submitted an application for certification as a euthanasia technician in an animal shelter for which they work.

"Certified euthanasia technician" is the designation to be used for the individual defined according to 16 Del.C. §3004F(d)(4d). "Certified euthanasia technician" means a person certified by a licensed veterinarian and the Office of Animal Welfare, after passing both a written and practical examination, as proficient to perform euthanasia in an animal shelter setting.

"Department'' means the Department of Health and Social Services or its duly authorized representatives.

"Euthanasia" means the act of inducing painless death.

"Intake" means the number of live animals for which an animal shelter assumes custody and are admitted for temporary shelter and care. Intake includes all animals admitted to the shelter, foster care, or a satellite location.

"Isolation" means the physical separation and confinement of an animal or group of animals who are infected with a communicable disease from non-isolated animals to prevent or limit the transmission of the disease.

"Licensed veterinarian" means a veterinarian licensed to practice veterinary medicine pursuant to Title 24 of the Delaware Code.

"Licensed veterinary technician" means an individual licensed as a veterinary technician pursuant to Title 24 of the Delaware Code.

"Office" means the Office of Animal Welfare or its duly authorized representatives.

"Outcome" means number of animals that left the shelter's custody.

"Pre-euthanasia anesthetics" means drugs administered prior to the administration of the euthanasia drug, which render an animal unconscious, immobilized, and with total loss of ability to perceive pain while retaining functions vital for life.

"Quarantine" means the physical separation and confinement of an animal or group of animals who have or may have been exposed to a contagious disease and who do not show signs or symptoms of communicable disease from nonquarantined animals to prevent or limit the transmission of the disease.

"Return to field" means a program whereby community cats that have been admitted to an animal shelter are returned to the place they were found after being processed as an intake, sterilized, ear-tipped, and vaccinated against rabies.

**History**
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *18 DE Reg. 866 (05/01/15)*
- *27 DE Reg. 530 (01/01/24)*

##### **16 Del. Admin. Code § 4501-3.0** Certification Requirements for Euthanasia Technicians {#sec-4501-3.0 omnilex-key=us-de-regs-official--title-16--4501-3.0}

3.1 Individuals who perform euthanasia in an animal shelter, other than a licensed veterinarian, a nationally certified euthanasia technician; or a licensed veterinary technician, must be trained and certified as set forth in this Section.

3.2 Individuals seeking certification as a euthanasia technician shall submit a written application documenting their qualifications to the Office of Animal Welfare, Carvel Building, 1901 N. Dupont Highway, New Castle, DE 19720.

3.3 In order to qualify for certification as a certified euthanasia technician, an applicant shall submit proof of the following requirements:

3.3.1 Is 18 years of age or older;

3.3.2 A criminal background check within 6 months of application showing the individual has not been convicted of any of the following:

3.3.2.1 Any felony offense.

3.3.2.2 A crime or infraction involving animal abuse or neglect.

3.3.2.3 Use, possession, sale, distribution, or traffic of illegal substances.

3.3.3 Is employed by a Delaware animal shelter;

3.3.4 Has successfully completed an approved euthanasia training course;

3.3.5 Has passed a written examination given by or approved by the Office of Animal Welfare ("Office"); and

3.3.6 Demonstrates proficiency in euthanasia procedure under the direct supervision of the shelter's staff veterinarian or consulting veterinarian.

3.4 The Office of Animal Welfare will receive and review all applications for euthanasia technician certification and determine eligibility.

3.5 For any person who is currently performing euthanasia, who is not a licensed veterinarian, a nationally certified euthanasia technician, or a licensed veterinary technician, the training requirement must be met within 6 months of the effective date of this regulation.

**History**
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *18 DE Reg. 866 (05/01/15)*
- *27 DE Reg. 530 (01/01/24)*

##### **16 Del. Admin. Code § 4501-4.0** Training of Certified Euthanasia Technicians {#sec-4501-4.0 omnilex-key=us-de-regs-official--title-16--4501-4.0}

4.1 The euthanasia training course shall be at least 12 hours and shall include both lecture and practical instruction.

4.2 The course must be administered by or approved by the Office of Animal Welfare and minimum curriculum requirements shall include:

4.2.1 Animal anatomy;

4.2.2 The pharmacology and proper administration of euthanasia drugs and pre-euthanasia anesthetics;

4.2.3 Proper dose calculation and record keeping, proper storage, handling and disposal of pre-euthanasia anesthetics and euthanasia drugs in accordance with state and federal laws;

4.2.4 Proper restraint and handling with emphasis on easing trauma and stress to the animal;

4.2.5 Proper injection techniques;

4.2.6 Techniques for properly and accurately verifying an animal's death;

4.2.7 The proper disposal of a euthanized animal; and

4.2.8 Euthanasia technician stress management.

4.3 There shall be at least 1 instructor per course who can provide proof of being proficient and experienced in intravenous and intraperitoneal administration of pharmaceuticals.

4.4 Following the lecture training detailed in subsection 4.2 of this regulation, the applicant shall take a written examination provided by or approved by the Office of Animal Welfare.

4.5 Those passing the written examination are eligible for the practical portion of the training during which the individual shall work under the direct supervision of the shelter's staff veterinarian or consulting veterinarian. Through practical training, the individual shall:

4.5.1 Demonstrate competency in applying the skills outlined in subsection 4.2; and

4.5.2 Exhibit respectful, professional, and compassionate behavior regarding the euthanasia process.

4.6 Once the supervising veterinarian deems the individual is proficient in giving intravenous and intraperitoneal injections, as well as making a positive determination of death, the veterinarian shall sign a proficiency statement and notify the Office of Animal Welfare.

**History**
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *18 DE Reg. 866 (05/01/15)*
- *27 DE Reg. 530 (01/01/24)*

##### **16 Del. Admin. Code § 4501-5.0** Approval of Euthanasia Training Course {#sec-4501-5.0 omnilex-key=us-de-regs-official--title-16--4501-5.0}

5.1 Any organization or institution desiring to conduct a euthanasia technician certification education program shall apply to the Office of Animal Welfare and submit satisfactory evidence that it is ready and qualified to instruct students in the prescribed basic curriculum for certifying euthanasia technicians and that is prepared to meet other standards which may be established by the Office. The organization or institution may not be an animal shelter in Delaware.

5.2 If the Office determines that any approved educational program is not maintaining the standards required by these regulations and by the Office, written notice thereof, specifying the deficiency and the time within which the same shall be corrected, shall immediately be issued to the program. The Office shall withdraw such program's approval if it fails to correct the deficiency within the time proscribed. The organization or institution may reapply for approval to the Office once the program meets standards established by the Office.

5.3 A euthanasia technician certification course approved by the American Humane Association, the American Veterinary Medical Association or The Humane Society of the United States shall be deemed to have the approval of the Delaware Office of Animal Welfare.

**History**
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *18 DE Reg. 866 (05/01/15)*
- *27 DE Reg. 530 (01/01/24)*

##### **16 Del. Admin. Code § 4501-6.0** Issuance of Certification {#sec-4501-6.0 omnilex-key=us-de-regs-official--title-16--4501-6.0}

6.1 Upon receipt of the required documentation listed in subsection 3.3 of these regulations, the Office of Animal Welfare shall issue a certificate of course completion which will serve as certification.

6.2 The Office of Animal Welfare may, by endorsement, without written examination, certify a euthanasia technician who has completed a training program that meets the educational requirements for certification defined by the Office and if, in the opinion of the Office, the applicant meets the qualifications specified by these regulations for an euthanasia technician.

6.3 Certificates shall be kept on file at the euthanasia technician's place of employment. A shelter shall notify the Office of Animal Welfare in writing, no later than 5 business days from the date of termination or resignation, of a certified euthanasia technician's employment.

6.4 A certified euthanasia technician shall notify the Office within 5 business days of change of employment from 1 Delaware animal shelter to another Delaware animal shelter, if applicable.

**History**
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *18 DE Reg. 866 (05/01/15)*
- *27 DE Reg. 530 (01/01/24)*

##### **16 Del. Admin. Code § 4501-7.0** Recertification and Revocation {#sec-4501-7.0 omnilex-key=us-de-regs-official--title-16--4501-7.0}

7.1 Recertification will be required every 3 years by applying to the Office of Animal Welfare and may be granted provided that the euthanasia technician is currently employed by a Delaware animal shelter and has not been convicted of any felony offense, crime or infraction involving animal abuse or neglect, or the use, possession, sale, distribution, or traffic of illegal substances within the previous 3 years.

7.2 To apply for recertification, the applicant shall submit to the Office of Animal Welfare a letter signed by their employer that they still meet the criteria listed in subsection 3.3 of these regulations and have remained proficient in giving intravenous and intraperitoneal injections, as well as making a positive determination of death.

7.3 If at any time the euthanasia technician fails to meet the original terms of certification, they are no longer employed by a Delaware animal shelter, or their employer requests revocation, the Office of Animal Welfare shall revoke their certification.

7.4 Any concerns regarding the technical proficiency of euthanasia, the ability to accurately confirm death, professional behavior, or the handling of animals being euthanized of a certified euthanasia technician should be directed to the Office immediately.

**History**
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *18 DE Reg. 866 (05/01/15)*
- *27 DE Reg. 530 (01/01/24)*

##### **16 Del. Admin. Code § 4501-8.0** Shelter Care and Treatment {#sec-4501-8.0 omnilex-key=us-de-regs-official--title-16--4501-8.0}

8.1 Animal shelters shall follow written veterinary care protocols developed with a licensed veterinarian, to include: evaluation and testing of newly impounded animals, disease control and prevention, and adequate veterinary care. In addition, animal shelters shall have a protocol for behavioral enrichment. Protocols shall take into consideration any species of animal for which the shelter provides care. These protocols shall be updated annually, approved by their advising veterinarian, available on site at all times, and with copies provided to the Department of Health and Social Services ("Department") upon request.

8.2 Animal shelters shall vaccinate all dogs against canine distemper virus, canine parvovirus, and bordetella bronchiseptica, and all cats against feline viral rhinotracheitis, calicivirus, and the panleukopenia virus before or upon entering the shelter or holding facility to reduce the spread of disease.

8.3 Vaccines should be administered as soon as possible, but no more than 8 hours after entering the shelter. For animals admitted overnight, such vaccines shall be given no later than noon. This provision shall not apply to animals in quarantine for rabies observation, or to animals having injuries, illness, or temperament that make administration of the vaccinations unsafe. If vaccines are not given to an animal due to 1 of these exceptions, the reason must be explained and well documented. The animal must be reassessed within a reasonable amount of time based on the condition. Vaccines shall be given as soon as safe to do so and be administered by a licensed veterinarian, veterinary technician, or trained shelter personnel under the direction of a veterinarian, veterinary technician, or animal care manager.

8.4 Each animal entering an animal shelter shall be evaluated at intake to check for signs of infectious disease or an injury or illness requiring emergency medical care. A full examination shall be performed within 48 hours of entry and prior to adoption. The examination must be performed by a licensed veterinarian, veterinary technician, or shelter personnel with knowledge and training in animal health assessment under the direction of a veterinarian, veterinary technician, or animal care manager. In rare circumstances where handling of an animal may be unsafe, the examination may be done visually with the reason for a visual examination clearly documented. Written examination findings must be kept in the animal's record and a copy provided to the Department upon request.

8.4.1 An examination shall include a minimum of the following information.

8.4.1.1 ID Check;

8.4.1.2 Weight;

8.4.1.3 Body condition score;

8.4.1.4 Check for external parasites;

8.4.1.5 Infectious/non-infectious disease status;

8.4.1.6 Any signs of injury or illness;

8.4.1.7 Treatment or vaccines given, dosage and provider; and

8.4.1.8 Behavior of the animal.

8.4.2 Animals in the shelter's custody for 1 year or more shall receive an examination by a veterinarian every 12 months.

8.5 Animals in isolation or quarantine shall not be in areas accessible by the public. Enclosures of animals with suspected contagious disease must be clearly marked to indicate the condition and any necessary precautions. Isolation and quarantine areas must be separated by species and meet the medical and behavioral needs of sick animals.

8.6 This section applies to all animals in the organization's custody whether at the shelter, in foster care, or a satellite location.

**History**
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *18 DE Reg. 866 (05/01/15)*
- *27 DE Reg. 530 (01/01/24)*

##### **16 Del. Admin. Code § 4501-9.0** Animal Adoption, Recovery, and Rehabilitation {#sec-4501-9.0 omnilex-key=us-de-regs-official--title-16--4501-9.0}

9.1 Animal shelters shall post all stray animals, except for kittens under 12 weeks of age, on Delaware Animal Services Lost and Found Registry and their website within 24 hours of intake. The website posting requirement may be satisfied by posting a prominent link to the registry on the shelter website: https://animalservices.delaware.gov. The posting shall contain a clear photo and sufficient detail to allow the animal to be recognized and claimed by their owners. Shelters may post stray animals on additional websites or through social media at their discretion.

9.2 Animal shelters shall be open to the public after normal business hours, including evenings and weekends, to increase access for purposes of reclaiming a lost pet or adoption. The hours for public access shall be posted at the facility and clearly visible from the outside. Hours shall also be posted on the shelter's website.

**History**
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *18 DE Reg. 866 (05/01/15)*
- *27 DE Reg. 530 (01/01/24)*

##### **16 Del. Admin. Code § 4501-10.0** Euthanasia in Animal Shelters {#sec-4501-10.0 omnilex-key=us-de-regs-official--title-16--4501-10.0}

10.1 Euthanasia shall be performed by a licensed veterinarian, a licensed veterinary technician, a nationally certified euthanasia technician, or a person certified by a licensed veterinarian as proficient to perform euthanasia (hereby referred to as certified euthanasia technician) after completion of the requirements outlined in Section 3.0. The certified euthanasia technician is only permitted to perform euthanasia on shelter animals within the animal shelter of which they are employed. No one other than the shelter or consulting veterinarian may perform euthanasia on privately owned animals.

10.2 Standards for the euthanasia area in animal shelters.

10.2.1 Each shelter shall have a specific area designated for euthanasia. That area shall be:

10.2.1.1 A separate room;

10.2.1.2 An area that is physically separated from the rest of the facility by a wall, barrier or other divider; or

10.2.1.3 An area that is not used for any other purpose while animals are being euthanized.

10.2.2 The following information shall be kept in the euthanasia area:

10.2.2.1 A written copy of the policy and procedure manual regarding euthanasia drafted by a licensed veterinarian of the shelter's choice;

10.2.2.2 Response protocols for accidental exposure of humans to euthanasia drugs or pre-euthanasia anesthetics;

10.2.2.3 Material Safety Data Sheets for euthanasia drugs and pre-euthanasia anesthetics; and

10.2.2.4 Current copy of euthanasia reference manual issued by the American Veterinary Medical Association, the American Humane Association, or The Humane Society of the United States.

10.2.3 The euthanasia area shall meet the following minimum standards:

10.2.3.1 Shall provide a safe, quiet environment in which to perform euthanasia.

10.2.3.2 Shall provide adequate space for 2 persons to perform euthanasia.

10.2.3.3 Lighting shall be bright and even and provide adequate illumination for inspection and identification of animals, performance of euthanasia procedures, and safe working conditions for personnel.

10.2.3.4 The air temperature shall be within a range of 65 degrees and 85 degrees Fahrenheit, a comfortable range for both personnel and animals.

10.2.3.5 The area shall have adequate ventilation that prevents accumulation of odors.

10.2.3.6 The floor of the area shall provide dry, non-slip footing to prevent accidents.

10.2.3.7 The area shall be one that can be easily cleaned and disinfected.

10.2.3.8 The area shall not be accessible to the public when euthanasia is being performed.

10.2.4 The euthanasia area shall have the following equipment and supplies:

10.2.4.1 A table or other work area where animals can be handled safely while euthanasia is performed.

10.2.4.2 Holding cages of the appropriate size available to hold an animal while waiting for a pre-euthanasia anesthetic or euthanasia drug to take effect, if needed, should be easily accessible in or near the room. These cages shall be maintained in a clean and sanitary condition. If these cages are in the euthanasia room, and occupied, no other animal may be euthanized at the same time pursuant to subsection 11.9.

10.2.4.3 Variety of syringes and needles. Needles are to be used only once.

10.2.4.4 A first aid kit.

10.2.4.5 One or more tourniquets.

10.2.4.6 Electric clippers with a number 40 blade in good working order.

10.2.4.7 Humane restraint devices for use on dogs and cats.

10.2.4.8 Stethoscope.

10.2.4.9 Towels, sponges and disinfectant.

10.2.4.10 Sharps disposal system.

10.2.4.11 Universal microchip scanner in good working order.

10.2.4.12 Logbook to record animal ID, weight of animal, drug names and amounts utilized for the euthanasia procedure.

10.2.5 All chemical agents, pre-euthanasia anesthetics, and euthanasia drugs used in the euthanasia area shall be clearly labeled, logged, and stored according to state and federal laws.

10.3 Subsections 10.1 and 10.2 do not apply to livestock and horses, which may be euthanized in an outdoor environment.

10.4 When deemed necessary due to severe injury or illness, and when it can be performed without risk to personal safety, humane euthanasia may be performed outdoors or in a transport vehicle if the animal is on shelter property.

**History**
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *18 DE Reg. 866 (05/01/15)*
- *27 DE Reg. 530 (01/01/24)*

##### **16 Del. Admin. Code § 4501-11.0** Euthanasia Methods and Procedures for Animal Shelters {#sec-4501-11.0 omnilex-key=us-de-regs-official--title-16--4501-11.0}

11.1 The use of sodium pentobarbital or sodium pentobarbital in combination with phenytoin sodium shall be the exclusive drugs for euthanasia of dogs and cats by animal shelters, given by the following acceptable methods:

11.1.1 Intravenous injection by hypodermic needle;

11.1.2 Intraperitoneal injection with sodium pentobarbital alone by hypodermic needle, if intravenous access is distressful, dangerous, or impractical and the animal is less than 10 lbs; or

11.1.3 Intracardiac injection by hypodermic needle may be performed only by a licensed veterinarian and only when performed on a deeply anesthetized or unconscious animal to whom intravenous or intraperitoneal cannot be successfully administered due to animal's physical condition.

11.2 Pre-euthanasia anesthetics shall be administered to animals who are aggressive, severely distressed, or frightened as directed by the shelter veterinarian. This does not prevent the use of pre-euthanasia anesthetics for other animals as instructed by the shelter veterinarian.

11.3 Small animal species other than dogs and cats should be humanely euthanized by the preferred methods recommended by the manuals listed in subsection 10.2.2.4.

11.4 Large animal species shall be euthanized by a licensed veterinarian proficient with the handling of horses and livestock.

11.5 To assure safe and humane euthanasia technique, a minimum of 2 persons shall be required for any euthanasia procedure. One person shall be a licensed veterinarian, licensed veterinary technician, or a certified euthanasia technician, and 1 or more persons shall be a handler. The handler should be trained in safe and humane animal handling techniques.

11.6 The identity of each animal to be euthanized must be determined with certainty prior to the procedure. This includes but is not limited to scanning for a microchip, verification of sex, breed, shelter ID number and distinguishing markings, and verifying that the animal is properly designated for the procedure.

11.7 Euthanasia must be authorized by the animal care/control manager, director, or veterinarian as appropriate for each animal for which euthanasia is performed. Documentation of this authorization shall be kept in the animal's record and a copy provided to the Department upon request.

11.8 No animal shall be left unattended between the time euthanasia procedures are first begun and the verification of death.

11.9 No animal shall be permitted to observe or hear the euthanasia of another animal, nor permitted to view the bodies of dead animals. This provision shall not apply to puppies and kittens with their mothers. When selected for euthanasia by the shelter veterinarian, mother animals should be euthanized prior to their offspring. The puppies or kittens should be euthanized immediately following the mother.

**History**
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *18 DE Reg. 866 (05/01/15)*
- *27 DE Reg. 530 (01/01/24)*

##### **16 Del. Admin. Code § 4501-12.0** Handling and Restraint of Animals for Euthanasia {#sec-4501-12.0 omnilex-key=us-de-regs-official--title-16--4501-12.0}

12.1 To minimize stress, fear and discomfort, the least amount of restraint that is necessary to perform the procedure safely shall be used. All animals shall be handled in a gentle and compassionate manner.

12.2 When animals are fearful, fractious or highly aroused, human contact should be minimized as to prevent injury and reduce stress to both the animal and the handler. For these animals, pre-euthanasia anesthesia shall be administered.

12.3 Catch poles are not to be used on cats.

**History**
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *18 DE Reg. 866 (05/01/15)*
- *27 DE Reg. 530 (01/01/24)*

##### **16 Del. Admin. Code § 4501-13.0** Confirmation of Death {#sec-4501-13.0 omnilex-key=us-de-regs-official--title-16--4501-13.0}

13.1 No dog, cat, or other species may have its body disposed of until death is confirmed by a licensed veterinarian, licensed veterinary technician, or a certified euthanasia technician. Verification of death shall be made by physical examination of the individual animal.

13.2 Methods for confirmation of death must be preceded by ensuring that the animal has neither a blink nor toe pinch reflex.

13.3 Methods for confirmation of death:

13.3.1 Complete lack of heartbeat and respiration as determined by stethoscope;

13.3.2 Lack of movement of a cardiac stick syringe; or

13.3.3 Onset of rigor mortis.

13.4 Verification of death is to be performed by 2 individuals.

**History**
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *18 DE Reg. 866 (05/01/15)*
- *27 DE Reg. 530 (01/01/24)*

##### **16 Del. Admin. Code § 4501-14.0** Record Keeping and Reporting for Animal Shelters {#sec-4501-14.0 omnilex-key=us-de-regs-official--title-16--4501-14.0}

14.1 Animal shelters shall maintain records regarding the following information:

14.1.1 Animal intake numbers by type:

14.1.1.1 Stray/at large;

14.1.1.2 Relinquished by owner;

14.1.1.3 Transfer in from in-state animal welfare organizations;

14.1.1.4 Transfer in from out-of-state animal welfare organizations;

14.1.1.5 Transfer in from international animal welfare organizations;

14.1.1.6 Impound/seizure; and

14.1.1.7 Other intakes.

14.1.2 Animal outcome numbers by type:

14.1.2.1 Adoption;

14.1.2.2 Return to owner;

14.1.2.3 Return to field;

14.1.2.4 Transfer out to in-state animal welfare organization;

14.1.2.5 Transfer out to out-of-state animal welfare organization;

14.1.2.6 Transfer out to international animal welfare organization;

14.1.2.7 Euthanasia;

14.1.2.8 Died in care; and

14.1.2.9 Lost in care.

14.1.3 Number of animals at beginning and end of period. This shall include all animals in the organization's custody whether at the shelter, in foster care, or a satellite location.

14.1.4 Number of spay/neuter surgeries performed for shelter and public animals broken down by species.

14.1.5 Records showing compliance with vaccination requirements.

14.1.6 Records regarding medical treatment provided.

14.1.7 Location and date of return for cats returned to field.

14.2 Animal statistics outlined in subsections 14.1.1 - 14.1.4 must be posted on the shelter's website on a quarterly and annual basis in a format determined by the Department. These statistics shall be posted no later than 30 days after the close of the quarter.

14.3 There shall be kept at each shelter a record of all animals received and their disposition. Such record shall state:

14.3.1 The origin of the animal, including the name and address of the organization or individual from whom the animal was acquired, if applicable, and date animal was received;

14.3.2 The unique identification number for each animal;

14.3.3 The description including species, estimated age, sex, color markings, and if spayed/neutered;

14.3.4 The location of the animal if not kept at shelter facility;

14.3.5 The medical condition at intake evaluation and full examination given within 48 hours of intake, and any subsequent medical care including examinations, treatments date and time, name and dosage of medication, and name of provider;

14.3.6 Vaccination history including date and time of all vaccines given, name of medication, and name of the provider; and

14.3.7 Disposition of animal, disposition date, name and address of person or organization if adopted or transferred; in the event of death of the animal, cause of death if known; if euthanized, the date, reason, method, person administering the procedure and handler.

14.4 Records shall be kept in accordance with these regulations and this section and shall be made available for review by the Department during any inspection or upon request.

14.5 Records must be maintained for a minimum period of 48 months from the date created unless otherwise directed by the Department.

14.6 A medical history to include examinations, vaccinations, all medical treatment, and behavior including known bite history shall be provided in written form with the animal at the time of adoption or transfer.

**History**
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *18 DE Reg. 866 (05/01/15)*
- *27 DE Reg. 530 (01/01/24)*

##### **16 Del. Admin. Code § 4501-15.0** Inspections and Complaints of Animal Shelters {#sec-4501-15.0 omnilex-key=us-de-regs-official--title-16--4501-15.0}

15.1 Inspections of animal shelters shall be conducted in accordance with 16 Del.C. §3008F.

15.1.1 Unannounced inspections will be performed at least annually. Additional inspections may be conducted to follow up on previous violations, in response to complaints, or as the Department deems necessary to ensure the health and well-being of the animals.

15.1.2 The Department or its duly authorized representative or representatives shall have the power to enter at all reasonable times, during ordinary business hours, for the purpose of determining whether there is compliance with or violations of 16 Del.C. Ch. 30F. If violations outside the scope of authority of the Department are discovered, the Department will notify the proper authorities.

15.1.3 The Department has the right to inspect all records pertaining to the animals that are the subject of these regulations and will be given access to view and copy such records.

15.1.4 All inspection findings will be documented in writing and a copy provided to the animal shelter within 30 days. Once provided to the animal shelter, findings will also be posted on the Department website.

15.2 Complaints. The Department shall investigate upon receipt of a written complaint of alleged violations of Title 16 Delaware Code.

15.2.1 All complaints shall be reviewed and complaints concerning violations of this chapter will be investigated by the Department or its designee.

15.2.2 The Department shall notify the animal shelter of the complaint within 30 days of receipt of said complaint. Based on nature of complaint, the Department may request assistance from the appropriate law enforcement agency having jurisdiction over the shelter.

15.2.3 The Department shall issue a final written report of violations to the animal shelter. The final report will also be posted to the Department website at the conclusion of the proceedings and after the animal shelter is notified.

15.3 The Department shall have the power to issue orders to correct deficiencies and to impose penalties pursuant to 16 Del.C. §107(a).

15.3.1 Notice of a violation shall be accompanied by an order that requires corrective action be taken. Violations must be corrected within the timeframe established by the Department. The order shall be signed by the Director or the Director's designee or any of the Director's appointed representatives and may require:

15.3.1.1 In instances where the health and welfare of animals is in imminent danger, the closure of the facility until correction of the violation is proven.

15.3.1.2 The acquisition or use of additional equipment, supplies, training, or personnel to ensure that the violation does not recur.

15.3.1.3 The submission of a plan to prevent future violations to the Department for review and approval.

15.3.1.4 Any other corrective action deemed necessary for proper compliance with this regulation including interim remedies pending correction of violations.

15.4 Hearing Request. An animal shelter may request a hearing if they wish to contest the findings of the investigation.

15.4.1 The request shall be made in writing to the Department within 30 days after publication of the findings. Within 30 days of receipt of the request for public hearing, the Department shall set a time and place to conduct a hearing on the complaint.

15.4.2 Notice of the hearing shall be provided and the hearing shall be conducted in accordance with the Administrative Procedures Act, Chapter 101 of Title 29, and the Freedom of Information Act, Chapter 100 of Title 29.

**History**
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *27 DE Reg. 530 (01/01/24)*
- *18 DE Reg. 866 (05/01/15)*
- *27 DE Reg. 530 (01/01/24)*

#### **4502** Regulations for Certification of Animal Welfare Officers

##### **16 Del. Admin. Code § 4502-1.0** Authority and Purpose {#sec-4502-1.0 omnilex-key=us-de-regs-official--title-16--4502-1.0}

1.1 These regulations are promulgated by the Delaware Department of Health and Social Services pursuant to 16 Del.C. §§122(3)bb and 139 pertaining to training and certification requirements for animal welfare officers.

1.2 The overall purpose of these regulations is to establish minimum training requirements for the certification of animal welfare officers working in the State of Delaware. These regulations also establish procedures for documenting all complaints filed against the officers/agents, and conducting investigations of complaints concerning violations of this chapter.

1.3 These regulations define:

1.3.1 Training and certification requirements for animal welfare officers;

1.3.2 Procedures for obtaining a certification from the Office of Animal Welfare;

1.3.3 Training course approval processes;

1.3.4 Continuing education and recertification obligations;

1.3.5 Disciplinary sanctions; and

1.3.6 Complaint documentation and investigation procedures.

1.4 Effective Date. These regulations are effective March 11, 2019.

**History**
- *22 DE Reg. 770 (03/01/19)*

##### **16 Del. Admin. Code § 4502-2.0** Definitions {#sec-4502-2.0 omnilex-key=us-de-regs-official--title-16--4502-2.0}

The following words or terms, when used in these regulations, shall have the meaning indicated, unless the context otherwise requires:

"Animal welfare officer" means any person qualified to act pursuant to 11 Del.C. §1325 and 16 Del.C. §3041F, notwithstanding additional training/certification requirements listed in those sections.

"Certified Animal Welfare Officer" means an individual who has been certified by the Office to perform animal control pursuant to Section 3.0.

"Department" means the Department of Health and Social Services or its duly authorized representatives.

"Office" means the Division of Public Health Office of Animal Welfare or its duly authorized representatives.

**History**
- *22 DE Reg. 770 (03/01/19)*

##### **16 Del. Admin. Code § 4502-3.0** Animal Welfare Officer Certification {#sec-4502-3.0 omnilex-key=us-de-regs-official--title-16--4502-3.0}

3.1 Except as permitted by subsection 4.7, below, no person shall serve as a Delaware animal welfare officer unless such person is trained and certified by the Office of Animal Welfare as set forth in this section.

3.2 Individuals seeking certification as an animal welfare officer shall submit a written application to the Department of Health and Social Services, Division of Public Health, Office of Animal Welfare.

3.3 In order to qualify for certification as an animal welfare officer, an applicant shall submit proof of the following requirements with their application:

3.3.1 Is eighteen (18) years of age or older;

3.3.2 Is employed as an animal welfare officer in Delaware. A letter of intent from an organization hiring the individual as an animal welfare officer may be accepted;

3.3.3 A Certified Delaware Criminal History, obtained at the State Bureau of Identification not more than 90 days prior to submitting an application for certification, showing the individual has no convictions or pending criminal charges of a crime against person or property;

3.3.4 Has successfully completed an animal control/welfare training course that has been approved by the Office;

3.3.5 Has passed an examination given by or approved by the Office; and

3.3.6 Has completed a minimum of 80 hours of infield training under the direction of one or more Certified Animal Welfare Officers currently working in that capacity. The infield training shall commence upon successful completion of the animal control/welfare training course and exam.

3.4 The Office may, by endorsement, without written examination, certify an animal welfare officer who has completed a training program that meets the educational requirements for certification defined in Section 4.0 and who, in the opinion of the Office, meets the qualifications specified by these regulations for an animal welfare officer.

**History**
- *22 DE Reg. 770 (03/01/19)*

##### **16 Del. Admin. Code § 4502-4.0** Training of Certified Animal Welfare Officers {#sec-4502-4.0 omnilex-key=us-de-regs-official--title-16--4502-4.0}

4.1 An animal welfare officer training course shall provide at least forty (40) hours of instruction.

4.2 The course must be administered by or approved by the Office and minimum curriculum requirements shall include:

4.2.1 Role and authority of an animal welfare officer;

4.2.2 Delaware laws governing rabies control, animal control and protection, dangerous dogs, animal cruelty, and enforcement powers;

4.2.3 Animal health and disease recognition, control, and prevention;

4.2.4 First aid for injured animals;

4.2.5 Principles and procedures for humanely capturing and handling domestic animals, wildlife, and livestock;

4.2.6 Criminal justice system, investigative techniques, rules of evidence, and report writing;

4.2.7 Principles of courtroom testimony and prosecution;

4.2.8 Communications, conflict resolution, and officer safety; and

4.2.9 Emergency management.

4.3 Following the training detailed in subsection 4.2, the applicant shall take an examination provided by or approved by the Office. Applicants who fail to obtain a minimum score of 75% after testing two times must repeat the training course before additional testing is permitted.

4.4 Upon completion of an examination outlined in subsection 4.3, the applicant shall complete a minimum of eighty (80) hours of infield training under the direction of one or more Certified Animal Welfare Officers currently working in that capacity.

4.5 The Office may waive the completion of all or part of the curriculum required in subsection 4.2 upon presentation of documentary evidence that the individual has satisfactorily completed equivalent training or experience.

4.6 An animal welfare officer, if serving as such on the effective date of this Rule shall, within 6 months after the effective date of this Rule, complete the certification requirements outlined in Section 3.0. Persons who fail to complete the certification requirement within 6 months after the effective date of this Rule will not be authorized to act as an animal welfare officer in the State of Delaware and shall be subject to penalties pursuant to 16 Del.C. §107(a).

4.7 An animal welfare officer hired on or after the effective date of this Rule shall, within 60 days after the date of hire, complete the certification requirements outlined in Section 3.0. Officers that have not completed the certification requirement within 60 days after the date of hire will not be authorized to act as an animal welfare officer in the State of Delaware.

**History**
- *22 DE Reg. 770 (03/01/19)*

##### **16 Del. Admin. Code § 4502-5.0** Approval of Training Course {#sec-4502-5.0 omnilex-key=us-de-regs-official--title-16--4502-5.0}

5.1 Any organization or institution desiring to conduct an animal welfare officer education program shall apply to the Office for approval. The organization must submit evidence, deemed satisfactory by the Office, that it is ready and qualified to instruct students in the prescribed basic curriculum for certifying animal welfare officers, and that it is prepared to meet other standards which may be established by the Office.

5.2 If the Office determines that any approved educational program is not maintaining the standards required by these regulations and by the Office, written notice thereof, specifying the deficiency and the time within which the same shall be corrected, shall immediately be issued to the program. The Office shall withdraw such program's approval if it fails to correct the deficiency within the time proscribed. The organization or institution may reapply for approval to the Office once the program meets standards established by the Office.

**History**
- *22 DE Reg. 770 (03/01/19)*

##### **16 Del. Admin. Code § 4502-6.0** Issuance of Certification {#sec-4502-6.0 omnilex-key=us-de-regs-official--title-16--4502-6.0}

6.1 The Office shall issue a certificate to each qualified applicant who has successfully met the requirements under subsection 3.3.

6.2 A copy of the certificate shall be kept on file at the animal welfare officer's place of employment.

6.3 The employer shall notify the Office in writing, no later than 10 days from the date of termination or resignation, of an animal welfare officer's employment. The employer shall state the reason for termination in the notification.

6.4 The Office shall maintain a current registry of all persons certified as animal welfare officers in the state.

6.5 If a certified animal welfare officer resigns or leaves the employment of an animal control/cruelty agency in good standing and is no longer working in the role of animal welfare officer, the officer's certification shall become inactive. If the officer is rehired as an animal welfare officer within 12 months, the certification will be reinstated to active. If the officer is not rehired within 12 months, the certification shall be revoked. The officer can apply for recertification once they become employed as an animal welfare officer.

6.6 If a certified animal welfare officer has been found by an employer to be unfit or incompetent, the Office may impose sanctions as outlined in subsection 9.3.

**History**
- *22 DE Reg. 770 (03/01/19)*

##### **16 Del. Admin. Code § 4502-7.0** Continuing Education and Recertification {#sec-4502-7.0 omnilex-key=us-de-regs-official--title-16--4502-7.0}

7.1 A certified animal welfare officer shall complete 8 hours of continued education and training by December 31 every calendar year, commencing the year after initial certification in order to maintain certification. The Office may grant an officer additional time for good cause, not to exceed one year, to complete the training.

7.2 Evidence of completion of the training shall be submitted to the Office within 30 days after training is completed to satisfy the continuing education requirement in subsection 7.1.

7.3 The certification of an animal welfare officer shall be suspended if the officer fails to satisfactorily complete the training in accordance with subsection 7.1. Training must be completed before the suspension may be lifted.

**History**
- *22 DE Reg. 770 (03/01/19)*

##### **16 Del. Admin. Code § 4502-8.0** Conducted Electrical Weapon (CEW) {#sec-4502-8.0 omnilex-key=us-de-regs-official--title-16--4502-8.0}

In order for an animal welfare officer to carry/use a conducted electrical weapon (CEW), he/she must complete a training program taught by a certified instructor and all certifications or re-certifications must be on file with the Office of Animal Welfare.

**History**
- *22 DE Reg. 770 (03/01/19)*

##### **16 Del. Admin. Code § 4502-9.0** Denial, Revocation and Disciplinary Sanctions {#sec-4502-9.0 omnilex-key=us-de-regs-official--title-16--4502-9.0}

9.1 The Office may impose sanctions, defined in this chapter singly or in combination when it finds a certified or former certified animal welfare officer committed any offense described below:

9.1.1 Engages in fraud or deceit in procuring or attempting to procure a certification/license;

9.1.2 Is guilty of a crime against person or property;

9.1.3 Has been found by an employer to be unfit or incompetent;

9.1.4 Has had a certification or license to serve as an animal welfare officer suspended or revoked in any jurisdiction; or

9.1.5 Has willfully or negligently violated this chapter.

9.2 In determining whether to impose sanctions, the Department shall consider the following factors:

9.2.1 The seriousness of the offense;

9.2.2 The circumstances surrounding the offense;

9.2.3 The relation of the offense to the duties of a certified animal welfare officer; and

9.2.4 Consultation with the certified animal welfare officer’s employing agency.

9.3 Disciplinary sanctions shall include one or more of the following:

9.3.1 Permanently revoking a certification;

9.3.2 Refusing a certification or certification renewal;

9.3.3 Suspending a certification;

9.3.4 Issuing a letter of reprimand;

9.3.5 Requiring additional training; or

9.3.6 Placing a certification on probationary status and requiring the individual to:

9.3.6.1 Report regularly to the Office upon the matters which are the basis of probation;

9.3.6.2 Limit practice to those areas prescribed by the Office; or

9.3.6.3 Continue or renew professional education until satisfactory degree of skill has been attained in those areas which are the basis of the probation.

9.4 An animal welfare officer may request an administrative hearing if they wish to contest the disciplinary sanctions.

9.4.1 The request shall be made in writing to the Secretary of the Department within 20 calendar days after issuance of the final written report and associated sanctions.

9.4.2 As soon as possible, but not later than 30 calendar days of receipt of the request for an administrative hearing, the Department shall set a time and place to conduct a hearing.

9.4.3 Notice of the hearing shall be given and the hearing conducted in accordance with the Administrative Procedures Act, 29 Del.C. Ch. 101, and the Freedom of Information Act, 29 Del.C. Ch. 100.

9.4.4 The Department shall make a determination based upon the evidence presented.

9.4.5 A written copy of the determination and the reasons upon which it is based shall be sent to the officer within 30 calendar days.

9.5 During an administrative hearing:

9.5.1 The animal welfare officer has the right to be represented by counsel;

9.5.2 All statements made shall be under oath;

9.5.3 The animal welfare officer has the right to examine and cross-examine witnesses; and

9.5.4 A stenographer recording will be made by a qualified court reporter. At the request and expense of any party, such record shall be transcribed with a copy to the other party.

9.6 The decision of the Department shall be based upon sufficient legal evidence. The Department may continue, modify or revoke the disciplinary sanctions.

9.7 All decisions of the Department shall be final and conclusive. Where the officer is in disagreement with the action of the Department, the officer may appeal the Department's decision to the Superior Court within 30 days of service or of the postmarked date of the copy of the decision mailed to the officer. The appeal shall be on the record to the Superior Court and shall be as provided in 29 Del.C. §§10142-10145.

**History**
- *22 DE Reg. 770 (03/01/19)*

##### **16 Del. Admin. Code § 4502-10.0** Documenting and Investigating Complaints {#sec-4502-10.0 omnilex-key=us-de-regs-official--title-16--4502-10.0}

10.1 The Office shall document all complaints filed directly with the Office or the employer against certified animal welfare officers of alleged violations of 16 Del.C. §139.

10.2 All complaints must be received in writing and shall be reviewed. Only complaints concerning violations of this chapter will be investigated by the Office. Complaints that do not involve alleged violations of 16 Del.C. §139 may be referred to the employer, another agency or entity as appropriate according to the subject matter of the complaint.

10.3 The Office shall notify the animal welfare officer and the officer's employer of the complaint investigation within 10 days of receipt of said complaint.

10.4 The Office shall issue a final written report of the complaint investigation findings and any associated disciplinary sanctions outlined in subsection 9.3 to the animal welfare officer and the officer's employer sent by Certified Mail or hand delivered. If the complaint concerns an officer employed by the Office of Animal Welfare, the complaint will be forwarded to the Division Director or Deputy Director for investigation.

**History**
- *22 DE Reg. 770 (03/01/19)*

### **5000** Delaware Health Care Commission

#### **5001** Delaware Health Insurance Individual Market Stabilization Reinsurance Program and Fund

##### **16 Del. Admin. Code § 5001-1.0** Purpose {#sec-5001-1.0 omnilex-key=us-de-regs-official--title-16--5001-1.0}

1.1 The purpose of these Regulations is to establish procedures for the Delaware Health Insurance Individual Market Stabilization Reinsurance Program and Fund established pursuant to House Bill No. 193, 150th General Assembly for the purpose of stabilizing insurance rates and premiums in the individual market and providing greater financial certainty to consumers of health insurance in the State.

1.2 Policies and procedures for implementation of these regulations may be established in manuals and other documents by the Executive Director of the Delaware Health Care Commission or the Cabinet Secretary of Delaware Health and Social Services.

1.3 Nothing in these regulations shall preempt or otherwise conflict with any applicable state and federal laws and rules.

**History**
- *24 DE Reg. 1003 (05/01/21)*
- *24 DE Reg. 1003 (05/01/21)*
- *24 DE Reg. 1003 (05/01/21)*
- *24 DE Reg. 1003 (05/01/21)*
- *23 DE Reg. 455 (12/01/19)*
- *24 DE Reg. 1003 (05/01/21)*

##### **16 Del. Admin. Code § 5001-2.0** Authority {#sec-5001-2.0 omnilex-key=us-de-regs-official--title-16--5001-2.0}

This regulation is promulgated pursuant to the authority granted in Chapter 99, Title 16, of the Delaware Code.

**History**
- *24 DE Reg. 1003 (05/01/21)*
- *24 DE Reg. 1003 (05/01/21)*
- *24 DE Reg. 1003 (05/01/21)*
- *24 DE Reg. 1003 (05/01/21)*
- *23 DE Reg. 455 (12/01/19)*
- *24 DE Reg. 1003 (05/01/21)*

##### **16 Del. Admin. Code § 5001-3.0** Definitions {#sec-5001-3.0 omnilex-key=us-de-regs-official--title-16--5001-3.0}

The following definitions shall apply to this regulation:

“Attachment point” means the threshold dollar amount, adopted by the Executive Director, after which point the claims costs of an insured individual’s covered benefits under a reinsurance-eligible health benefit plan in a benefit year are eligible for reinsurance payments.

“Benefit year” means a calendar year beginning on or after January 1, 2020 for which reinsurance eligible health benefit plan provides health insurance coverage.

“Cabinet Secretary” means the Cabinet Secretary of Delaware Health and Social Services.

“Coinsurance rate” means the rate at which the Executive Director may reimburse a reinsurance eligible health benefit plan for claims costs incurred after the attachment point and before the reinsurance cap for an insured individual’s covered benefits in a benefit year.

“Commission” or “DHCC” means the Delaware Health Care Commission created pursuant to 16 Del.C. §9902.

“DHSS” means Department of Health and Social Services.

“DOI” means Department of Insurance.

“Executive Director” means the Executive Director of the Delaware Health Care Commission (DHCC) or designee.

“Health insurance carrier” or “carrier” means any entity that provides health insurance in this State. For the purposes of this regulation, carrier includes an insurance company, health service corporation, health maintenance organization, managed care organization, and any other entity providing a plan of health insurance or health benefits subject to state insurance regulation. The entities providing insurance under the following types of plans do not meet the definition of carrier, per this regulation: plans of health insurance or health benefits designed for issuance to persons eligible for coverage under Titles XVIII, XIX, and XXI of the Social Security Act (42 U.S.C. §§1395 et seq., 1396 et seq., and 1397aa et seq.), known as Medicare, Medicaid; Chapter 52 of Title 29 of the Delaware Code; or any other similar coverage under state or federal governmental plans. Additionally, this regulation shall not apply to stand-alone dental insurance, stand-alone vision insurance, long-term care insurance, disability income insurance and all accident-only insurance.

“Health insurance coverage” means legal entitlement to payment or reimbursement for health care costs, generally under a contract with a health insurance company or a group health plan offered in connection with employment.

“Program” means the Delaware Health Insurance Individual Market Stabilization Reinsurance Program created by 16 Del.C. §9903(g).

“Regulations” means all parts of the Rules and Regulations pertaining to the Delaware Health Insurance Individual Market Stabilization Reinsurance Program.

“Reinsurance cap” means the threshold dollar amount, adopted by the Executive Director, for claims costs incurred by a reinsurance eligible health benefit plan for an insured individual’s covered benefits in a benefit year, after which threshold the claims costs for the benefits are no longer eligible for reinsurance payments.

“Reinsurance eligible claim” means a claim for services covered under a reinsurance eligible health benefit plan that is incurred by a reinsurance eligible issuer during the applicable benefit year and within the period of eligibility for the member that is paid by the reinsurance eligible issuer before June 1 of the following year. A reinsurance eligible claim shall not be adjusted for risk nor for pharmacy rebates. A reinsurance eligible claim does include a claim for certain abortion services, as defined in 45 CFR §156.280(d)(1).

“Reinsurance eligible health benefit plan” means health insurance coverage offered on the individual market that:

1. Constitutes minimum essential coverage, as set forth in 26 U.S.C. §5000A(f);

2. Is approved by the State’s Insurance Commissioner;

3. Is delivered or issued for delivery by a carrier in the State; and

4. Is not a grandfathered plan as defined in §1251 of the Patient Protection and Affordable Care Act. 29 CFR §2590.715-1251.

“Reinsurance eligible individual” means an individual who is insured in a reinsurance eligible health benefit plan on or after January 1, 2020.

“Reinsurance eligible issuer” means a health insurance carrier that offers a reinsurance eligible health benefit plan to reinsurance eligible individuals.

“Reinsurance payment” means payments issued to a reinsurance eligible issuer in accordance with Section 6.0.

“State” means the State of Delaware.

**History**
- *24 DE Reg. 1003 (05/01/21)*
- *24 DE Reg. 1003 (05/01/21)*
- *24 DE Reg. 1003 (05/01/21)*
- *24 DE Reg. 1003 (05/01/21)*
- *23 DE Reg. 455 (12/01/19)*
- *24 DE Reg. 1003 (05/01/21)*

##### **16 Del. Admin. Code § 5001-4.0** Information Reporting {#sec-5001-4.0 omnilex-key=us-de-regs-official--title-16--5001-4.0}

4.1 The State entered into an intergovernmental agreement with the U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services (CMS), to calculate reinsurance payments to issuers participating in the State of Delaware's reinsurance program under Delaware's State Innovation Waiver under section 1332 of the Patient Protection and Affordable Care Act. CMS will identify paid claims eligible for reimbursement under the reinsurance program from data submitted to "EDGE Servers."

4.2 Carriers must sign an attestation that they meet the submission and data requirements of the State Reinsurance Program through their participation in CMS EDGE Server.

4.3 A reinsurance eligible issuer must submit one interim report due on March 31st after the benefit year, containing de-identified data from the prior benefit year with claims paid by February 28th or February 29th, and an estimate of claims payments still outstanding. This report will be used to aid the Executive Director in setting parameters for future program years; the EDGE Server, and not this report, shall be used to calculate the paid claims eligible for reimbursement under the reinsurance program. The report shall be issued using a secure method of transmission approved by the Executive Director. The Executive Director may, in his or her discretion, waive the interim report.

4.4 The interim report must contain the following data elements for the individual ACA plan:

4.4.1 De-identified Member ID;

4.4.2 Benefit Year Member Months;

4.4.3 Benefit Year Incurred Claims (paid through February 28th or February 29th of the current calendar year); and

4.4.4 Estimate of prior Benefit Year claim payments outstanding, e.g., to be paid after February 28th or February 29th of the current calendar year.

4.5 DHCC shall annually receive from the Department of Insurance the actual Second Lowest Cost Silver Plan premium under the Affordable Care Act 1332 waiver, 45 U.S.C. §18052, and an estimate of the premium as it would have been without the waiver.

4.6 If the State's participation in the CMS EDGE Server were to be discontinued, as a condition of receiving reinsurance payments from the program, a reinsurance eligible issuer would provide the following information to the program in the form and manner prescribed by the Executive Director:

4.6.1 The name and company code assigned to the reinsurance eligible issuer by the National Association of Insurance Commissioners;

4.6.2 The identification number assigned to the reinsurance eligible issuer by the DHCC;

4.6.3 The total amount of the reinsurance eligible issuer's reinsurance eligible claims for the benefit year;

4.6.4 The portion of the reinsurance eligible issuer's total reinsurance eligible claims for the benefit year that fall between the attachment point and reinsurance cap;

4.6.5 A summary data file containing de-identified information for each reinsurance eligible individual with claims for which reinsurance payments are being requested:

4.6.5.1 The start and end dates of coverage for the reinsurance eligible individual;

4.6.5.2 The DHCC plan identification number for the reinsurance eligible health benefit plan in which the reinsurance eligible individual was enrolled;

4.6.5.3 The total amount of reinsurance eligible claims for the reinsurance eligible individual for the benefit year; and

4.6.5.4 The total amount of reinsurance eligible claims for the reinsurance eligible individual for the benefit year that fall between the attachment point and reinsurance cap.

4.6.6 If requested by the Executive Director de-identified claims file extracted from the reinsurance eligible issuer's claims processing system that includes the issuer's complete record of all reinsurance eligible claims for the benefit year, in accordance with applicable state and federal confidentiality laws;

4.6.7 An attestation signed by an executive officer of the reinsurance eligible issuer stating that the information is accurate as of the date of submission; and

4.6.8 Any other information requested by the Executive Director that he or she deems necessary to administer the program, in accordance with applicable state and federal confidentiality laws.

**History**
- *24 DE Reg. 1003 (05/01/21)*
- *24 DE Reg. 1003 (05/01/21)*
- *24 DE Reg. 1003 (05/01/21)*
- *24 DE Reg. 1003 (05/01/21)*
- *23 DE Reg. 455 (12/01/19)*
- *24 DE Reg. 1003 (05/01/21)*

##### **16 Del. Admin. Code § 5001-5.0** Reinsurance Parameters {#sec-5001-5.0 omnilex-key=us-de-regs-official--title-16--5001-5.0}

Annually, the Executive Director shall set an attachment point, cap, and coinsurance rate for the reinsurance program for the upcoming year based on anticipated revenue and recently reported premium, enrollment, and claims data.

**History**
- *24 DE Reg. 1003 (05/01/21)*
- *24 DE Reg. 1003 (05/01/21)*
- *24 DE Reg. 1003 (05/01/21)*
- *24 DE Reg. 1003 (05/01/21)*
- *23 DE Reg. 455 (12/01/19)*
- *24 DE Reg. 1003 (05/01/21)*

##### **16 Del. Admin. Code § 5001-6.0** Reinsurance Payments {#sec-5001-6.0 omnilex-key=us-de-regs-official--title-16--5001-6.0}

6.1 A reinsurance eligible issuer becomes eligible for a reinsurance payment when the claims costs for at least one reinsurance eligible individual’s covered benefits in a calendar year exceed the attachment point.

6.2 Under the intergovernmental agreement with CMS, the Executive Director receives from CMS reports detailing the reinsurance payments on a cumulative basis, to date, owed to each reinsurance eligible issuer.

6.2.1 Subject to subsections 6.2.2 and 6.2.3, the reinsurance payment made to each reinsurance eligible issuer for a benefit year will be the product of the coinsurance rate and the portion of the reinsurance eligible issuer’s total reinsurance eligible claims for the benefit year that fall between the attachment point and the reinsurance cap.

6.2.2 The Executive Director shall uniformly reduce or increase the coinsurance rate to the extent necessary, but at no time shall the increase exceed 100%, to ensure that reinsurance payments do not exceed the total available funding for the benefit year, as determined by the Executive Director in his or her sole discretion.

6.3 The program shall issue reinsurance payments to all reinsurance eligible issuers on an annual basis in the year following each benefit year. The Executive Director shall issue a payment schedule to all issuers.

6.4 Payments shall be made directly to reinsurance eligible issuers by a method designated by the Executive Director.

6.5 If the Executive Director determines that a reinsurance eligible issuer has substantively failed to comply with this regulation, he or she shall give notice thereof to the issuer stating the Executive Director's findings and stating how the nonconformance can be remedied. The Executive Director shall specify a time period for remedying the nonconformance. The program shall not issue reinsurance payments until the nonconformance is remedied.

**History**
- *24 DE Reg. 1003 (05/01/21)*
- *24 DE Reg. 1003 (05/01/21)*
- *24 DE Reg. 1003 (05/01/21)*
- *24 DE Reg. 1003 (05/01/21)*
- *23 DE Reg. 455 (12/01/19)*
- *24 DE Reg. 1003 (05/01/21)*

##### **16 Del. Admin. Code § 5001-7.0** Duties of the Administrator {#sec-5001-7.0 omnilex-key=us-de-regs-official--title-16--5001-7.0}

7.1 The program shall be administered by the Executive Director. As administrator of the program, the Executive Director may:

7.1.1 Conduct an audit of the information received under Section 4.0.

7.1.2 Notify reinsurance eligible issuers of the results of the calculation described in Section 6.0, including any modifications of the coinsurance rate once DHCC receives the results from CMS.

7.1.3 Issue reinsurance payments to each reinsurance eligible issuer in accordance with Section 6.0.

7.1.4 Assign the functions vested in him or her by the Delaware Health Insurance Individual Market Stabilization Reinsurance Program and these regulations to subordinate officers and employees as he or she deems necessary. The designee shall have the same power and authority that would be afforded to the Executive Director.

7.1.5 Contract with other state agencies and third parties as he or she deems necessary to administer the program.

7.1.6 Use, access, store, and disclose the information submitted to the program under Section 4.0, including disclosing the information to the Insurance Commissioner, in accordance with applicable state and federal confidentiality laws, for the purposes of ensuring the efficient administration of the program and to reduce the reporting burden on issuers.

7.1.7 Submit an annual report to the Governor and General Assembly, in consultation with the DHSS and DOI and in accordance with applicable state and federal confidentiality laws.

7.1.8 Perform other functions he or she deems reasonably necessary to administer the program.

**History**
- *24 DE Reg. 1003 (05/01/21)*
- *24 DE Reg. 1003 (05/01/21)*
- *24 DE Reg. 1003 (05/01/21)*
- *24 DE Reg. 1003 (05/01/21)*
- *23 DE Reg. 455 (12/01/19)*
- *24 DE Reg. 1003 (05/01/21)*

##### **16 Del. Admin. Code § 5001-8.0** Document Retention and Audits {#sec-5001-8.0 omnilex-key=us-de-regs-official--title-16--5001-8.0}

8.1 A reinsurance eligible issuer must maintain documents and records, whether paper, electronic, or in other media, sufficient to substantiate its requests for reinsurance payments made pursuant to this regulation for a minimum period of 10 years and must make those documents and records available to the program upon request by the Executive Director for purposes of verification, investigation, or audit, in accordance with applicable state and federal confidentiality laws.

8.2 The Executive Director may audit a reinsurance eligible issuer to assess its compliance with the requirements of this regulation. The reinsurance eligible issuer must ensure that its relevant contractors, subcontractors, or agents cooperate with any audit under this Section. If an audit results in a finding of material weakness or significant deficiency with respect to compliance with any requirement of this Section, the reinsurance eligible issuer must complete all of the following:

8.2.1 Within 30 calendar days of the issuance of the final audit report, provide a written corrective action plan to the program for approval;

8.2.2 Implement that plan; and

8.2.3 Provide to the program written documentation of the corrective actions once taken.

8.3 If, at the conclusion of the audit, the Executive Director determines that a reinsurance eligible issuer received excess reinsurance payments, at the request of the Executive Director, the reinsurance eligible issuer shall return the excess payments to the program in a manner to be determined by the Executive Director within 60 days of his or her request.

**History**
- *24 DE Reg. 1003 (05/01/21)*
- *24 DE Reg. 1003 (05/01/21)*
- *24 DE Reg. 1003 (05/01/21)*
- *24 DE Reg. 1003 (05/01/21)*
- *23 DE Reg. 455 (12/01/19)*
- *24 DE Reg. 1003 (05/01/21)*

##### **16 Del. Admin. Code § 5001-9.0** Severability {#sec-5001-9.0 omnilex-key=us-de-regs-official--title-16--5001-9.0}

If any provisions of this regulation or the application thereof to any person or circumstance shall be held invalid, such invalidity shall not affect the provisions or application of these regulations which can be given effect, and to this end the provisions of these regulations are declared to be severable.

**History**
- *24 DE Reg. 1003 (05/01/21)*
- *24 DE Reg. 1003 (05/01/21)*
- *24 DE Reg. 1003 (05/01/21)*
- *24 DE Reg. 1003 (05/01/21)*
- *23 DE Reg. 455 (12/01/19)*
- *24 DE Reg. 1003 (05/01/21)*

#### **5002** Delaware Health Resources Management Plan

##### **16 Del. Admin. Code § 5002** Delaware Health Resources Management Plan {#sec-5002 omnilex-key=us-de-regs-official--title-16--5002}

This document is provided in PDF due to the size and formatting of the document.

Delaware Health Resources Management Plan

https://regulations.delaware.gov/AdminCode/title16/Department of Health and Social Services/Delaware Health Care Commission/HRMP.pdf

**History**
- *21 DE Reg. 222 (09/01/17)*

### **6000** Division of Substance Abuse and Mental Health

#### **6001** Substance Abuse Facility Licensing Standards

##### **16 Del. Admin. Code § 6001-1.0** Purpose {#sec-6001-1.0 omnilex-key=us-de-regs-official--title-16--6001-1.0}

The Department is issuing these regulations to promote the health and well being of consumers/clients receiving services in substance abuse treatment facilities located within the State of Delaware. They are not intended to limit additional contract standards for substance abuse treatment facilities and programs with which a service provider may be expected to comply.

**History**
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *12 DE Reg. 464 (10/01/08)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*

##### **16 Del. Admin. Code § 6001-2.0** Authority and Applicability {#sec-6001-2.0 omnilex-key=us-de-regs-official--title-16--6001-2.0}

The Department is authorized by 16 Del.C., Ch. 22 to license and regulate substance use disorderand co-occurring treatment facilities. These regulations shall apply to any facility as defined in 16 Del.C., Ch. 22, and Ch. 51 and address the minimum acceptable standards and programmatic conditions for consumers/clients receiving services in substance use disorder and co-occurring disorder treatment facilities. No organization or entity shall manage or operate a substance abuse treatment facility within the State of Delaware unless it has been so licensed by the Department.

**History**
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *12 DE Reg. 464 (10/01/08)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*

##### **16 Del. Admin. Code § 6001-3.0** Definitions {#sec-6001-3.0 omnilex-key=us-de-regs-official--title-16--6001-3.0}

The following words and terms, when used in these regulations, shall have the following meaning unless the context clearly indicates otherwise:

“Adjunct and alternative therapy” means a specific modality of therapy based on a specific valid body of knowledge, provision of which requires specific credentials. Examples include, but are not limited to, Psychodrama; Art Therapy; Music Therapy; Acupuncture; Massage Therapy; EMDR; etc.

“Administrator” means an individual who is authorized by the governing body to provide overall management of the agency.

“Admission” means the point in a client’s relationship with a program when the intake process has been completed and the program begins to provide additional services.

“Advisory Council” means a group of individuals approved by the governing body, to provide community input and recommendations to the governing body.

“Agency” means any partnership, corporation, association, or legal entity except for an individual practitioner, that provides, is seeking to provide, or holds itself out as providing alcohol and/or other drug treatment or rehabilitation services. An agency may operate more than one program.

“Applicant” means any agency that has submitted a written application for a license to operate an alcohol and/or other drug abuse treatment or rehabilitation program in Delaware.

“Client” means an individual who receives, or has received services from an agency.

“Client Record” means the official legal written file for each client containing all the information required by these regulations, and maintained to demonstrate compliance with these regulations.

"Clinical director" means an individual who, by virtue of education, training, and experience, satisfies the requirements of §6.1.2.1 and/or §16.2.3 of these regulations and is authorized by the Administrator to provide clinical oversight of the treatment program. The Clinical director may also serve as Clinical supervisor when directed to do so by the agency's governing body.

"Clinical supervisor" means an individual who, by virtue of education, training, and experience, satisfies the requirements of §6.1.3.1 of these regulations; and is authorized by the Administrator and/ or the governing body to provide clinical supervision for all clinical staff.

“Continuing care” means those services recommended to the client upon discharge from a program that support and increase the gains made during the client’s treatment at that program.

“Counseling” means the process in which a Counselor I or Counselor II works with a client, family, significant other, or a group of clients, families or significant others, to assist them to understand issues, consider alternatives, and change behaviors.

“Counselor I” means an individual who, by virtue of education, training, and experience meets the requirements of §6.1.4.1 of these regulations and functions under the supervision of a Clinical supervisor.

“Counselor II” means an individual who, by virtue of education, training, and experience, meets the requirements of §6.1.5.1 of these standards and functions under the supervision of a Clinical supervisor.

“Cultural Competence” means acceptance and respect for difference, continuing self-assessment regarding culture, careful attention to the dynamics of difference, continuous expansion of cultural knowledge and resources, and a variety of adaptations to service models in order to better meet the needs of minority populations. Culturally competent agencies work to hire unbiased employees, seek advice and consultation from the minority community, and actively decide what they are and are not capable of providing to minority clients. (March, 1989, Towards a Culturally Competent System of Care, Volume 1, National Technical Assistance Center for Children’s Mental Health, Georgetown University Child Development Center, p. 17.)

“Day” unless otherwise specified, one (1) day is a calendar day.

“Deemed status” means a licensure standing approved by DSAMH and bestowed upon programs that have been accredited by an accreditation body approved by DSAMH. Programs that have been granted Deemed Status will be inspected in accordance with §4.3.2 of these standards.

“Designee” means the person who is delegated tasks, duties, and responsibilities when such designation is permitted by these regulations.

“Discharge” means the point at which a client’s active involvement with an agency is terminated.

“Division/DSAMH” means the Delaware Division of Substance Abuse and Mental Health within the Delaware Department of Health and Social Services.

“Division Director” means the Director of the Delaware Division of Substance Abuse and Mental Health within the Delaware Department of Health and Social Services, or his/her designee.

“Documentation” means a written record acceptable as evidence to substantiate compliance with these regulations.

“DSM” means the Diagnostic and Statistical Manual of Mental Disorders, most recent edition, as published by the American Psychiatric Association.

“Facility” means the physical area, grounds, building(s) or portions thereof, under direct program administrative control.

“Follow-up” means the process for determining the status of an individual who has been referred to an outside resource for services or who has been discharged from services OR the process for determining an agency’s compliance with these standards after an agency audit has been completed.

“Governing Body” means the individual or individuals responsible for the overall management of an agency, responsible for ensuring compliance with 5.0 of these regulations.

"Initial Recovery Plan" means the first recovery plan developed on the first day of treatment. The initial recovery plan is a working document created with input from the client and program staff.

“Intake” means the gathering of personally identifying and clinical data required to determine whether a client should be admitted to a program.

“Intern” means a student who performs counseling functions under the supervision of a Clinical supervisor.

“License” means the document issued by the Division that authorizes a program to provide alcohol and/or other drug treatment or rehabilitation.

“Licensed Nurse” means a Registered Nurse or a Licensed Practical Nurse.

“Licensed Practical Nurse” means a person licensed by the State of Delaware as a Practical Nurse or a person licensed by a state that participates in the National Licensure Compact (NLC).

“Licensure” means the process by which the Division determines whether or not a program is in compliance with these regulations.

“Medical history” means history of and any treatment of allergies, head injuries, nervous disease/disorders, seizure disorder, or delirium tremens, surgery, major accidents, fractures, venereal diseases, cardiovascular, respiratory, endocrine, gastrointestinal diseases or disorders, and gynecological-obstetrical history, including current involvement in prenatal care and current medical treatment by a Primary Care Physician or other medical doctor.

"Needs Assessment" means a systematic evaluation of current system and programmatic operations and projected needs. This evaluation is performed as part of the Quality Assurance Plan and focuses on the changing needs of the community and population served.

“Nurse Practitioner” means a person licensed by the State of Delaware as a Nurse Practitioner or a person licensed by a state that participates in the National Licensure Compact (NLC).

"Periodic Recovery Plan Review/Revision" is a process whereby the clinical supervisor, and counselor, review prior recovery plans and establish new goals based on the client's progress and/or changing needs through out treatment.

“Physician” means a person licensed to practice medicine in the State of Delaware.

“Physician Assistant” means a person licensed by the State of Delaware as a Physician Assistant.

“Policy” means a statement of the principles that guide and govern the activities, procedures and operations of a program.

“Procedure” means a series of activities designed to implement the policies of a program.

“Program” means the location or facility where an agency provides or offers to provide any of the various modalities of service when such services are provided or offered on a regularly scheduled basis. Clinical participation records of clients are EITHER stored on-site OR readily available to staff in electronic format using computer hardware that is installed or regularly available on-site.

“Protocols” means a written rule developed by an agency to govern specific procedures or certain activities.

“Provisional License” means the document issue by the Division that authorizes a program to provide alcohol and/or other drug treatment or rehabilitation for up to one hundred and eighty (180) days when the applicant is not in compliance with these regulations or is applying for licensure for the first time.

“Public place” means an area accessible to clients, employees or visitors; the main entry or hallway; the reception area or foyer; or the dining or multipurpose room.

“Qualified Medical Personnel” means a physician, physician’s assistant, or nurse practitioner, licensed by the State of Delaware.

"Qualified Psychiatric Practitioner" means a physician or nurse practitioner, licensed by the State of Delaware with specific clinical experience in the treatment of substance use disorders as well as mental health disorders. Qualified Psychiatric Practitioners must have specific training in the use of buphrenorphine and Opioid antagonist medications as well as the use of psychotropic medications used with individuals who have a mental health diagnosis.

“Quality Assurance” means the process of objectively and systematically monitoring and evaluating the quality and appropriateness of client care to identify and resolve identified issues.

“Readmission” means the point in a client’s relationship with an agency when a client has been discharged, subsequently reapplied for admission, intake has been completed, and the agency begins to provide services again.

“Registered Nurse” means a person licensed by the State of Delaware as a registered nurse or a person licensed by a state that participates in the National Licensure Compact (NLC).

“Shall” means a mandatory procedure, the only acceptable method under these regulations.

“Signature/Signed” means, at a minimum, the writers’ first initial, last name, title or credentials and date or an authentic digital signature OR the client or legal guardian’s first and last name and/or date when required.

“Significant other” means an individual, whether or not related by blood or marriage, on which another individual relies for support.

“Staff” means full-time and part-time employees, consultants and volunteers, students/interns.

“Treatment” means the process a client undergoes to understand his or her alcohol or drug use and/or mental health diagnosis and choices made to change his or her behavior.

“Volunteer” means a person who, without direct financial compensation, provides services to a program.

“Waiver” means the exemption from compliance with a requirement of these regulations.

**History**
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *12 DE Reg. 464 (10/01/08)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*

##### **16 Del. Admin. Code § 6001-4.0** License Application Procedures {#sec-6001-4.0 omnilex-key=us-de-regs-official--title-16--6001-4.0}

4.1 Applicability

4.1.1 Any entity seeking to operate a substance use treatment program or a co-occurring, (substance use disorder with mental health disorders) treatment program shall be licensed in accordance with these regulations for each program it seeks to operate. Each facility's license shall list one or more categories of service that the facility is authorized to provide and the facility's location.

4.1.1.1 Program categories for which licenses may be issued are:

4.1.1.1.1 Residential Detoxification: substance use disorders

4.1.1.1.2 Ambulatory Detoxification (Amdetox):

4.1.1.1.3 Outpatient Treatment: substance use disorders or co-occurring disorders,

4.1.1.1.4 Opioid treatment: substance use disorders,

4.1.1.1.5 Residential Treatment: substance use disorders,

4.1.1.1.6 Transitional residential treatment: substance use disorders.

4.2 Application Procedures

4.2.1 The Division may supply an application packet to all applicants upon request. Applications can also be obtained by visiting the Division's website at: www.dhss.delaware.gov/dhss/dsamh/regs.html.

4.2.2 All persons and agencies applying for the first time for a license shall schedule a meeting with DSAMH Quality Assurance staff for the purpose of receiving needed technical assistance regarding the licensure criteria and procedures.

4.2.3 A separate application shall be completed for each program at each location at which an agency intends to operate a substance use disorder and/or co-occurring program.

4.2.4 The applicant may withdraw the application at any time by notifying the Division in writing.

4.3 Required Information

4.3.1 An applicant for licensure shall submit the following information on forms provided by the Division:

4.3.1.1 Name and address of the applicant;

4.3.1.2 Name, address and qualifications of the agency director, program director and/or partners, including copies of the professional licenses each has been issued by the State of Delaware;

4.3.1.3 Articles of incorporation and bylaws, and/or partnership agreement;

4.3.1.4 Name and address, occupation and place of employment, of the program director, board members, advisory board members, and officers.

4.3.1.5 A chart of the staff organization with names and qualifications;

4.3.1.6 A description of the services to be provided by the program, including a statement of the program philosophy, goals, and objectives and a description of the methodology for each service element;

4.3.1.7 A copy of the program’s complete proposed policies and procedures manual if the application is for initial licensure;

4.3.1.8 Documentation of applicable insurance coverage, including protection of the physical and financial resources of the program; coverage for all people, buildings and equipment; professional and general liability insurance; workers’ compensation; fidelity bonding sufficient to cover all client funds, property and interests; and automobile insurance when vehicles owned by the program are used for client transportation;

4.3.1.9 A floor plan for any facility not previously licensed;

4.3.1.10 For residential and detoxification facilities, the maximum client capacity requested; and

4.3.1.11 A copy of the program’s business license, if required.

4.3.2 Applicants applying for Deemed Status shall meet all standards as outlined in §17.0, §18.0 and §19.0 of these standards (as applicable).

4.3.3 Applicants shall supply all information requested on the application. The completed application shall be accompanied by a $15.00 fee in accordance with 16 Del.C. §2205. The Division shall not consider any application until it is properly completed and payment has been received.

4.4 Application Processing

4.4.1 The Division shall determine whether an application is complete and shall notify the applicant in writing if additional information is required to complete the application or determine the applicant’s compliance with these regulations.

4.4.2 The Division shall investigate and consider each completed application. An applicant for renewal shall submit its completed application at least ninety (90), but not more than one hundred and twenty (120), days before its current license expires.

4.5 Investigations and Inspections

4.5.1 By applying for or accepting a license, an applicant or licensee authorizes the Division and its representatives to conduct the inspections and investigations necessary to determine compliance with applicable licensing standards.

4.5.2 Agencies applying for licensure shall have the following information available for inspection by the Division:

4.5.2.1 Materials demonstrating compliance with all related Federal, State and local statutes, ordinances, rules and regulations [e.g., fire, health, building, American’s with Disabilities Act] applicable to the facility being licensed,

4.5.2.2 A copy of the program’s policies and procedures manual as required in §5.1.4;

4.5.2.3 Materials demonstrating compliance with the relevant sections of Provisions Regarding Modalities of these regulations; and

4.5.2.4 Materials demonstrating compliance with all other applicable licensing authorities and accreditation authorities when applicable.

4.5.3 Investigations and inspections may include on-site inspections of the program and its operation; inspection and copying (in accordance with 42 CFR Part 2 and HIPAA 45 CFR Parts 160 and 164) of program records, clinical records and other documents maintained by the program; and acquisition of other information, including otherwise privileged or confidential information from any other persons who may have information bearing on the applicant’s or licensee’s compliance or ability to comply with these regulations.

4.5.4 The Division shall review, update and when necessary, amend these regulations no less than every three (3) years.

4.6 Division Report

4.6.1 Upon completion of any inspection, the Division shall compile a Survey Summary Report citing strengths and recommendations for addressing deficiencies in meeting these standards.

4.6.2 The Division shall schedule an exit interview with each program for review of the Survey Summary Report.

4.7 Corrective action plans

4.7.1 Within ten (10) working days after the receipt of a survey summary report, the program shall submit a corrective action plan to the Division, addressing all areas where recommendations were made, unless otherwise directed by the Division.

4.7.2 The corrective action plan shall include a description of the corrective measures the program will take to address the regulation cited in the survey summary report, a target date for implementation of each corrective measure, and a description of the preventive measures implemented to ensure ongoing compliance with these regulations.

4.7.3 The Division may perform follow-up on-site inspections to review the implementation of corrective action plan(s).

4.8 Actions on applications for licensure

4.8.1 On the basis of the information supplied by the applicant and any other information acquired during its investigation and inspection, the Division may take any one of the following actions:

4.8.1.1 Issue or renew a full license for a period of up to two years when the Division determines a program is in substantial compliance with Chapter 22 of Title 16 Del.C., and these regulations, and/or has been granted Deemed Status or

4.8.1.2 Issue or renew a full license for a period of up to one year when the Division determines a program is in compliance with Chapter 22 of Title 16 Del.C., and these regulations;

4.8.1.3 Issue or renew a full license for a period of up to one year when the Division determines a program that has been granted Deemed Status is not in compliance with Chapter 22 of Title 16 Del.C. and these regulations or regulations set forth by the accreditation body; or

4.8.1.4 Issue a provisional license for up to one hundred and eighty (180) days when the program is not in compliance with Chapter 22 of Title 16 Del.C., or regulations set forth by the accreditation body upon which Deemed Status has been granted (when applicable) and the applicant’s failure to meet the requirements of Chapter 22 of Title 16 Delaware Code and these regulations does not jeopardize the health, safety and well-being of clients. The Division may issue one renewal of a provisional license for a period not to exceed ninety (90) days. (The Division’s decision to issue a provisional license instead of a full license is final and not subject to administrative appeal;) or

4.8.1.5 Issue a temporary license for up to ninety (90) days when additional time is required by the Division to inspect or investigate theprogram, additional time is required by the applicant to undertake remedial measures or complete a corrective action plan, when the program’s failure to meet the requirements of Chapters 22 and 51 of Title 16 Delaware Code, and these regulations does not jeopardize the health, safety and well-being of clients. A temporary license is not renewable and shall expire automatically without notice or hearing. (The Division’s decision to issue a temporary license instead of a full or provisional license is final and not subject to administrative appeal,) or

4.8.1.6 Revoke, suspend or deny a license in accordance with §4.9 and §4.10.

4.8.2 The Division may issue a single renewal of a license, for one (1) year, without an on site inspection by the Division.

4.8.3 The Division shall notify the program by mail, phone, email or any combination of the above of its licensure decision.

4.9 Access by the Division

4.9.1 A program is subject to review, which may include on site inspection, with or without notice, by the Division.

4.9.2 The Division’s right to monitor shall include complete access to all clients, staff, board members, and to all client, staff, financial and administrative program records needed for the purposes of monitoring or evaluation of the program’s compliance with these regulations, financial auditing or for research. The Division may review and copy records in accordance with 42 CFR Part 2 and HIPAA 45 CFR parts 160 and 164.

4.10 Nonassignability; Change in circumstances; Posting

4.10.1 A license for the operation of a substance use program applies to both the program and the premises upon which the program operates. Licenses are not transferable, remain the property of the Division, and shall be returned upon request.

4.10.2 A program’s current license shall be posted in a public place at its facility.

4.10.3 The Division issues each license on the basis of information available to it on the date the license is issued. An program or licensee shall give written notice to the Division of any change of program name, ownership, governing authority, premises or location a minimum of thirty (30) days before such change takes effect. The Division will determine within fifteen (15) days whether a new application is required.

4.10.4 Any person or entity acquiring a licensed substance use program shall apply for a new license in accordance with these regulations.

4.10.5 A licensee shall notify the Division in writing sixty (60) days prior to a voluntary closure of any program it is operating. The notice shall detail how the licensee will comply with §8.1.4.

4.10.6 The licensee shall provide written notice to clients no less than thirty (30) days prior to closure and shall make reasonable efforts to place clients in appropriate programs in compliance with §8.1.3.

4.11 Relationship to funding

4.11.1 The issuance of a license to a program is not a commitment of by the Division to fund the program.

4.12 Reasons for denial, suspension or revocation of license

4.12.1 A license may be denied, suspended or revoked for one or more of the following reasons:

4.12.1.1 When a program submits false information to the Division for licensing purposes;

4.12.1.2 When a program fails to cooperate with the Division in connection with a licensing inspection or investigation;

4.12.1.3 When a program has deviated from the category of service listed on its license;

4.12.1.4 When an applicant or program fails to be in compliance with the requirements of these regulations for the types of services for which application was made or for which the program was licensed, as outlined in §4.1.

4.12.1.5 When an applicant or program fails to implement the corrective action plan it submitted pursuant to §4.7, unless the Division approves an extension or modification of the corrective action plan;

4.12.1.6 When a program has violated any part of Title 16 Del.C., Chapter 22 or these regulations;

4.12.1.7 When a program has a history of, or currently demonstrates, financial insolvency, such as

4.12.1.7.1 Filing for bankruptcy;

4.12.1.7.2 Being subjected to foreclosure, eviction for failure to pay rent, or termination of utility services for failure to pay bills; or

4.12.1.7.3 Failing to pay such taxes as employment or social security in a timely manner.

4.12.1.8 When the program is in violation of a safety or sanitation law or regulation and fails to correct the violation;

4.12.1.9 When the program, its governing body or owner participates in, condones or is associated with fraud, deceit, coercion, misrepresentation or any other illegal act;

4.12.1.10 When the program, or any of its personnel or governing body violate professional ethics;

4.12.1.11 When the program, or any of its personnel or governing body, permits, aids or abets the commission of an unlawful act within its facilities or permits, aids or abets the commission of an unlawful act involving chemical substances within the program; or

4.12.1.12 When the program, or any of its personnel or governing body, has participated in, condoned, associated with or knows or should have known and has permitted the continuation of any other practice that jeopardizes the safety or health or well being of any client.

4.13 Procedure when a license is denied, suspended or revoked

4.13.1 In accordance with 16 Del.C. 2208, when the Division determines that an applicant or licensee fails to meet minimum compliance with the requirements of these regulations for the types of services for which application was made or for which the program was licensed or has committed an act or engaged in conduct or practices justifying denial, suspension or revocation of licensure:

4.13.1.1 The Division shall notify the applicant or licensee by certified mail, return receipt requested, of its intent to deny, suspend or revoke the license. The “Notice of Intended Action” shall include the particular reason(s) for the proposed action and provision for a fair hearing.

4.13.2 Within ten (10) days after receipt of the “Notice of Intended Action,” an applicant or licensee may request a hearing by delivering a written request to the Division Director in person or by certified mail, return receipt requested. If no such request is made within ten (10) days, the Secretary of the Department shall proceed to deny, revoke or suspend said license as set forth in the notice of proposed action.

4.13.3 Within fifteen (15) days after receipt of an applicant’s or licensee’s request for a hearing, the Division Director shall issue a “Notice of Hearing” to the applicant or licensee and to the public. The “Notice of Hearing” shall include a statement of the time, place and nature of the hearing, a statement of the legal authority and jurisdiction under which the hearing is to be held; a reference to the particular provisions of the statutes and rules involved; and a short and plain statement of the matters asserted.

4.13.4 All hearings conducted under this subsection shall be governed by procedures authorized by rules of the Department; the Department or its agent may take testimony concerning any matter within its jurisdiction and may administer oaths, summons or subpoenas for any witness and subpoenas duces tecum, which shall be served and returned as provided by law.

4.13.5 At the hearing, the applicant or licensee shall have the right to cross-examine witnesses against it, produce witnesses in its favor and to appear personally or by counsel.

4.13.6 All hearings shall be open to the public and a full record and transcript of the proceedings shall be prepared. The Secretary of the Department shall make a determination, which shall specify the Department’s findings of fact and conclusions. A copy of the determination shall be sent by certified mail, return receipt requested, or be personally served upon the applicant or licensee.

4.13.7 Copies of the transcription may be obtained by any interested party on payment of the cost of preparing such copies.

4.14 Procedure for reinstatement of suspended or revoked license

4.14.1 If the licensee has not previously had a license revoked or suspended under these rules, it may, at any time after the suspension or revocation determination is final, request a hearing for the purpose of showing that the reasons for revocation or suspension of the license have been corrected and that the license should be reinstated.

4.14.2 No licensee who has previously had a license suspended or revoked under these rules may request a hearing to reinstate the license prior to one year after the determination becomes final.

4.14.3 The request for a hearing shall be in writing and shall be delivered to the Secretary of the Department in person or by certified mail, return receipt requested.

4.14.4 Any hearing conducted under this subsection shall not operate to stay or supersede any decision revoking or suspending a license.

4.14.5 Hearings under this subsection shall be conducted in accordance with 29 Del.C. Chps. 100 and 101 and 4.13 of these regulations.

4.15 Waiver

4.15.1 An application for a waiver from a requirement of these regulations shall be made in writing to the Division's Director of Quality Assurance; it shall specify the regulation from which waiver is sought, demonstrate that each requested waiver is justified by substantial hardship, and describe the alternative practice(s) proposed. The waiver request shall be posted in a prominent place in the facility and outline a process approved by the Division whereby clients can offer comments and feedback specific to the waiver request. The Division's Director of Quality Assurance Unit shall make a recommendation of action on the application to the Division Director or designee. The Division Director or designee will review the request and recommendations and make final waiver request decisions.

4.15.2 No waiver shall be granted if such action would result in an activity or condition that would endanger the health, safety or well-being of a client.

4.15.3 A waiver granted under these regulations shall be in effect for the term of the applicant's license. If a waiver is required for an additional period of time, it shall be requested as part of the licensure renewal process in accordance with §4.15.

4.15.4 An adverse decision by the Division on a request for a waiver may be appealed in accordance with §4.13.

4.15.5 The granting of a waiver does not constitute a modification of any requirement of these regulations.

4.15.6 Licensees shall notify the Division within ten (10) working days when a waiver granted by the Division is no longer needed.

4.15.7 The Division Director may revoke a waiver when the alternative practice proposed in the application for waiver is determined to be ineffectual.

4.15.8 The Division Director may revoke the waiver when the program fails to implement the alternative practice as proposed in the application for waiver.

Part II--General Provisions

**History**
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *12 DE Reg. 464 (10/01/08)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*

##### **16 Del. Admin. Code § 6001-5.0** Standards Applicable to all Facilities and Programs {#sec-6001-5.0 omnilex-key=us-de-regs-official--title-16--6001-5.0}

5.1 Governance

5.1.1 Governing Body/Advisory Council.

5.1.1.1 Every community-based agency shall have a governing body and/or advisory council that includes representatives of the population it serves.

5.1.1.2 The governing body shall be legally responsible for overseeing all management and operations of the agency and for ensuring compliance with applicable laws and regulations by approving all of the agency’s staffing, documentation and overall operations:

5.1.1.2.1 Written by-laws;

5.1.1.2.2 Mission;

5.1.1.2.3 Goals;

5.1.1.2.4 Policies and Procedures; and

5.1.1.2.5 Budget.

5.1.1.3 The authority and duties of the governing body shall include:

5.1.1.3.1 Ensuring that the agency director, program directors, clinical supervisors and Counselors employed by the agency meet the requirements of §6.1 of these regulations.

5.1.1.3.2 Establishing and reviewing:

5.1.1.3.2.1 Policies and procedures governing the overall management of the program including:

5.1.1.3.2.1.1 Policies and procedures manual; (§5.1.4),

5.1.1.3.2.1.2 Fiscal management policies and procedures; (§5.1.5),

5.1.1.3.2.1.3 Personnel policies and procedures; (§5.1.6.2), and

5.1.1.3.2.1.4 Compliance with these regulations.

5.1.1.4 The Governing Body will meet, at a minimum, one (1) time per year. Documentation of its annual review shall be entered into the minutes of its meeting.

5.1.2 Meetings and minutes of meetings.

5.1.2.1 Minutes of all meetings shall include:

5.1.2.1.1 Names of members who attended;

5.1.2.1.2 Names of members absent;

5.1.2.1.3 Date of meeting;

5.1.2.1.4 Topics discussed and decisions reached.

5.1.2.2 The minutes shall be available for review by the Division.

5.1.3 Administrative Staff

5.1.3.1 Administrator

5.1.3.1.1 The governing body shall appoint an agency director.

5.1.3.1.2 The qualifications, authority, and duties of the agency director shall be defined in writing.

5.1.3.1.3 The Governing body shall ensure that, at the time of employment, the agency director is familiar with the job description and job responsibilities of the position, these regulations, and the agency’s policies and procedures as maintained in compliance with §5.1.4.

5.1.4 Policies and procedures manual:

5.1.4.1 Each program shall have a manual of written policies from which written procedures have been derived to address operations and services. The program’s policies and procedures manual shall be:

5.1.4.1.1 A complete document;

5.1.4.1.2 Readily available to staff.

5.1.4.2 The program’s policies and procedures manual shall be reviewed at least annually by the governing body or its designee.

5.1.4.3 The review shall be documented in the meeting minutes.

5.1.4.4 The manual shall include:

5.1.4.4.1 A statement of program philosophy and goals, including:

5.1.4.4.1.1 Geographical area to be served;

5.1.4.4.1.2 Population to be served;

5.1.4.4.1.3 Types of services offered;

5.1.4.4.1.4 Organization chart,

5.1.4.4.1.5 Policies and procedures to ensure compliance with §5.1.5, Fiscal management;

5.1.4.4.1.6 Personnel files

5.1.4.4.1.7 The intake procedures

5.1.4.4.1.8 The diagnostic assessment procedure established program director in compliance with §8.1.2.1.7.

5.1.4.4.1.9 Referral criteria policies and procedures.

5.1.4.4.1.10 Admission criteria policies and procedures;

5.1.4.4.1.11 Discharge criteria policies and procedures that specify conditions under which clients may be involuntarily discharged, including client behavior that constitutes grounds for discharge by the program.

5.1.4.4.1.12 Established procedures consistent with 42 CFR §2.12(c)(5) and HIPAA 45 CFR parts 160 and 164 that staff shall follow when discharging a client involved in the commission of a crime on the premises of the program or against its staff, including designation of the person who shall make a report to the appropriate law enforcement program;

5.1.4.4.1.13 Established procedures consistent with 42 CFR Part 2 and HIPAA 45 CFR parts 160 and 164 that staff shall follow when a client leaves against medical or staff advice and the client may be dangerous to self or others;

5.1.4.4.1.14 Confidentiality policy and procedures that comply with 42 CFR Part 2 and HIPAA 45 CFR parts 160 and 164;

5.1.4.4.1.15 Policies and procedures in regard to completion and utilization of all forms used by the program;

5.1.4.4.1.16 Policies and procedures for making mandated reports of suspected child abuse or neglect in compliance with 16 Del.C. §§902 through 904, 3910, 1132, 2224, 5194 and 42 CFR § 2.12(c)(6) (including non-retaliation policies when personnel report abuse and neglect.);

5.1.4.4.1.17 Policies and procedures for communicating with law enforcement personnel when a client commits or threatens to commit a crime on program premises or against program personnel, in compliance with 42 CFR § 2.12(c)(5) and HIPAA 45 CFR parts 160 and 164;

5.1.4.4.1.18 Policies and procedures for mandated reporting of infectious or contagious diseases, in compliance with state law and 42 CFR Part 2 and HIPAA 45 CFR Parts 160 and 164;

5.1.4.4.1.19 Medication policies and procedures, in compliance with the Delaware State Boards of Medical Practice, Nursing, and Pharmacy;

5.1.4.4.1.20 Policies and procedures, as applicable, for the collection of urine specimens;

5.1.4.4.1.21 Policies and procedures for responding to medical emergencies;

5.1.4.4.1.22 Policies and procedures regarding clients’ rights

5.1.4.4.1.23 Code of ethics; and

5.1.4.4.1.24 Policies and procedures for reporting any violations of law or codes of ethics to the appropriate certification and/or licensure boards.

5.1.5 Fiscal management policies and procedures and record keeping

5.1.5.1 Each program shall establish written policies and procedures regarding fiscal management that shall be maintained in compliance with generally accepted accounting principles.

5.1.6 Personnel policies and procedures.

5.1.6.1 Each program shall develop and maintain a written personnel manual that shall include:

5.1.6.1.1 Staff rules of conduct consistent with due process including:

5.1.6.1.1.1.1 Examples of conduct that constitute grounds for disciplinary action;

5.1.6.1.1.1.2 Examples of unacceptable performance that constitute grounds for disciplinary action;

5.1.6.1.1.1.3 Policies and procedures on mental health, and alcohol and drug abuse problems of staff (including staff member assistance policies and procedures);

5.1.6.1.2 Safety and health of staff, including:

5.1.6.1.3 Rules about any required medical examinations and rules about communicable diseases that could affect the health or safety of the program’s clients or staff.

5.1.6.2 Each agency shall maintain a separate personnel file for each staff member in a manner that ensures the privacy of agency staff.

5.1.6.3 The personnel file shall include at a minimum:

5.1.6.3.1 the name and telephone number of a person the agency can contact in an emergency;

5.1.6.3.2 The current job title and job description signed by the staff member;

5.1.6.3.3 Either:

5.1.6.3.3.1 an application for employment signed by the staff member; or

5.1.6.3.3.2 a resume;

5.1.6.3.4 A copy of the staff member’s license and/or current alcohol or other drug Counselor certification and/or Co-Occurring Counselor’s certification.

5.1.6.3.5 The results of reference investigations and verification of experience, training and education, including:

5.1.6.3.5.1 primary source verification of the staff member’s educational degree certificate(s), based on job description;

5.1.6.3.5.2 primary source verification of the staff member’s license(s), and/or certification(s), as applicable, based on job description;

5.1.6.3.5.3 A statement signed by the staff member acknowledging that s/he understands the requirements of 42 USC §290dd-2, 42 CFR Part 2 and HIPAA 45 CFR parts 160 and 164;

5.1.6.3.5.4 Documentation of the staff member’s annual written performance evaluation;

5.1.6.3.5.4.1 Any disciplinary actions taken against the staff member;

5.1.6.3.5.4.2 Formal corrective action taken, that:

5.1.6.3.5.4.2.1 The staff member has signed;

5.1.6.3.5.4.2.2 His/her immediate supervisor has signed;

5.1.6.3.5.5 A copy of the staff member’s training plan, as required in §5.1.7.1;

5.1.6.3.5.6 Documentation of the staff member’s abilities to provide culturally competent services; and

5.1.6.3.5.7 Documentation of in-service training and continuing education as required by §5.1.7.

5.1.6.4 Counselor II’s personnel files shall also include:

5.1.6.4.1 Documentation that the Counselor II is working toward meeting the requirements of §6.1.5; and

5.1.6.4.2 Documentation of Supervision as required in §12.2.4.

5.1.6.5 Records documenting all required staff member health clearances, including any medical test results required by agency policy shall be made available to the Division upon request.

5.1.7 Staff training and development

5.1.7.1 Each program shall establish a written staff training and development plan. The plan shall include:

5.1.7.1.1 An orientation curriculum, that will ensure that all staff are familiar with the agency policies and procedures, and have a working knowledge of at least the following:

5.1.7.1.1.1 Personnel policies and procedures, regarding the health and safety of staff, established in compliance with §5.1.6.1.2;

5.1.7.1.1.2 Program policies and procedures regarding the reporting of cases of suspected child abuse or neglect in compliance with 16 Del.C. §§902 through 904, 910, 1132, 2224, 5194 and 42 CFR § 2.12(c)(6), including non-retaliation policies when personnel report abuse and neglect;

5.1.7.1.1.3 Program policies and procedures regarding client’s rights established in compliance with §7.1, as applicable;

5.1.7.1.1.4 Instruction and training in the elements of the fire plan in compliance with §9.2;

5.1.7.1.1.5 Program policies and procedures regarding the obligation to report violations of law and applicable codes of ethics to the appropriate certification and/or licensure boards, established in compliance with §5.1.4.4.1.24.

5.1.7.1.1.6 Program policies and procedure regarding the training of all staff regarding culturally competent practices.

5.1.7.2 Programs shall annually establish an individual training plan for each staff member based on the staff member’s skill level, education, experience, current job functions, and job performance.

5.1.7.3 Programs providing co-occurring services shall include training and education specific to co-occurring disorders in the training plan for each staff member, based on the staff member's skill level, education and experience, job functions and job performance.

5.1.7.4 Clinical supervisors and all staff providing counseling services to clients shall complete at least twenty (20) hours of training annually, including:

5.1.7.34.1 Ten (10) hours specific to training and education in the treatment of alcohol and other drugs of abus.

5.1.7.4.1.1 When providing co-occurring services the ten (10) hours of training will be a combination of substance use disorders as well as mental health disorders.

5.1.7.4.2 Three (3) hours specific to training and education in providing culturally competence services every two years; and

5.1.7.4.3 Three (3) hours of training specific to ethics training and education every two years.

5.1.7.5 Adjunctive and Alternative Therapies

5.1.7.5.1 Every program utilizing any modalities of adjunct or alternative therapy shall ensure:

5.1.7.5.1.1 Adjunctive or alternative therapies are approved by the program director or designee prior to utilization;

5.1.7.5.1.2 Individuals providing the services of Adjunctive or alternative therapies have received specific training and/or credentials applicable to each modality.

5.1.7.6 All staff, trainees and volunteers shall receive training within the first year of employment about:

5.1.7.6.1 Hepatitis;

5.1.7.6.2 HIV/AIDS;

5.1.7.6.3 Tuberculosis;

5.1.7.6.4 Other sexually transmitted diseases;

5.1.7.6.5 Infectious Control.

5.1.8 Quality Assurance

5.1.8.1 Every agency shall have a written quality assurance plan.

5.1.8.2 The plan shall be reviewed and revised annually.

5.1.8.3 The quality assurance plan shall provide for the review of:

5.1.8.3.1 Clinical services to include:

5.1.8.3.1.1 The provision of culturally competent services including:

5.1.8.3.1.1.1 An annual self assessment that focuses on the needs of the community which the agency serves;

5.1.8.3.2 Professional services;

5.1.8.3.3 Administrative services;

5.1.8.3.4 Infection Control; and

5.1.8.3.5 Environment of Care.

5.1.8.4 The results of quality assurance review shall document:

5.1.8.4.1 The problem(s) identified;

5.1.8.4.2 The recommendations made;

5.1.8.4.3 The action(s) taken;

5.1.8.4.4 The individual(s) responsible for implementation of actions; and

5.1.8.4.5 Any follow-up.

5.1.8.5 Every agency shall develop and implement performance indicators and assess outcome measures.

5.1.8.6 Every program shall provide a mechanism to collect opinions from service recipients, personne and other stakeholders regarding the quality of service provided. Information shall be submitted to the appropriate committee for quality assurance review.

5.1.8.7 Every program shall conduct a needs assessment at a minimum of every five (5) years. The results of the needs assessment should determine staffing patterns and types of services to be provided with changes and updates recorded as part of the agency's quality assurance plan.

**History**
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *12 DE Reg. 464 (10/01/08)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*

##### **16 Del. Admin. Code § 6001-6.0** Standards Applicable to all Facilities and Programs {#sec-6001-6.0 omnilex-key=us-de-regs-official--title-16--6001-6.0}

6.1 Staff Qualifications for Substance use Disorders Treatment Staff

6.1.1 Qualifications for the Position of Administrator

6.1.1.1 Each agency shall have an administrator responsible for the overall management of the agency and/or program and staff.

6.1.1.2 Each administrator hired or promoted on or after the date these regulations become effective shall have at a minimum:

6.1.1.2.1 A Bachelor’s Degree from an accredited college or university with at least 5 years of documented experience in human services including:

6.1.1.2.1.1 at least two (2) years of experience in substance abuse treatment; and

6.1.1.2.1.2 at least two (2) years of management experience.

6.1.2 Qualifications for the Position of Clinical Director

6.1.2.1 Each individual, hired or promoted, to the position of Clinical Director on or after the date these regulations become effective shall have, at a minimum:

6.1.2.1.1 A master's degree in counseling or a related discipline and five (5) years of documented clinical experience in human services, at least three (3) years of which shall be in substance use services.

6.1.2.1.2 A Bachelor's Degree from an accredited college or university with a major in chemical dependency, psychology, social work, counseling, nursing or a related field, full certification as a certified alcohol and drug cCounselor (CADC) or certified co-occurring disorder professional (CCDP) in the state of Delaware or by a nationally recognized organization in addictions counseling and five (5) years of documented experience in substance use services.

6.1.3 Qualifications for the Position of Clinical Supervisor

6.1.3.1 Each individual authorized, hired, or promoted, to provide clinical supervision on or after the date these regulations become effective shall meet one of the following:

6.1.3.1.1 A Bachelor’s Degree from an accredited college or university with a major in chemical dependency, psychology, social work, counseling, nursing or a related field of study and full certification as a certified alcohol and drug Counselor (CADC) or certified co-occurring disorder professional (CCDP) in the state of Delaware or by a nationally recognized organization in addictions counseling; or

6.1.3.1.2 A Bachelor’s Degree from a accredited college or university with a major in chemical dependency, psychology, social work, counseling, nursing or a related field of study and five (5) years of documented clinical experience in the substance abuse treatment field.

6.1.4 Qualifications for the Position of Counselor I

6.1.4.1 Each individual hired or promoted on or after the date these regulations become effective shall meet one of the following requirements:

6.1.4.1.1 Full certification as a certified alcohol and drug Counselor (CADC) in the state of Delaware; or

6.1.4.1.2 Full certification by a nationally recognized body in addictions counseling or co-occurring counseling; or

6.1.4.1.3 Five (5) years of clinical experience working in the field of substance abuse treatment.

6.1.5 Counselor II

6.1.5.1 Qualifications for the Position of Counselor II

6.1.5.1.1 A person who does not meet the educational and experiential qualifications for the position of Counselor as set forth in §6.1.4 may be employed as an Counselor II if the requirements of at least one of the following paragraphs are met:

6.1.5.1.1.1 The individual has worked in the substance abuse treatment field for less than five years.

6.1.5.1.1.2 The individual is a student enrolled in a course of study while completing a practicum or internship;

6.1.5.1.1.3 The individual is working toward full certification in addictions counseling or co-occurring counseling by the Delaware Certification Board or a nationally recognized certification organization.

6.1.5.2 Counselor IIs must receive clinical supervision by the clinical supervisor a minimum of one (1) hour per every twenty (20) hours of clinical services provided to clients.

6.1.5.3 The clinical supervisor must review all documentation developed by the Counselor II for accuracy and clinical appropriateness.

6.1.5.3.1 The review shall be documented and placed in the Counselor II's personnel file.

**History**
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *12 DE Reg. 464 (10/01/08)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*

##### **16 Del. Admin. Code § 6001-7.0** Standards Applicable to all Facilities and Programs {#sec-6001-7.0 omnilex-key=us-de-regs-official--title-16--6001-7.0}

7.1 Clients’ Rights

7.1.1 Nondiscrimination policy

7.1.1.1 No program shall deny any person equal access to its facilities or services on the basis of race, color, religion, ancestry, sexual orientation, gender expression, national origin, or disability.

7.1.1.2 No program shall deny any person equal access to its facilities or services on the basis of age or gender, except those programs that specialize in the treatment of a particular age group (such as adolescents) or gender (such as mothers and infants).

7.1.1.3 All agencies shall ensure that they comply with the federal Americans with Disabilities Act, 28 U.S.C. §§12101 et seq. and 28 Code of Federal Regulations, Part 36 (July 1991) and 16 Del.C. §2220.

7.1.2 Enumerated Rights

7.1.2.1 All agencies shall ensure that clients’ rights are fully protected as enumerated in Del.C. §2220 and, including the following:

7.1.2.1.1 To be free from retaliation for exercising any enumerated right;

7.1.2.1.2 To file a grievance or complaint with the program in accordance with its policy and procedures. Procedures for receiving, investigating, hearing, considering, responding to and documenting grievances shall:

7.1.2.1.2.1 Include a procedure for receipt of grievances from clients or persons acting on their behalf;

7.1.2.1.2.2 Provide for the investigation of the facts supporting or disproving the grievance;

7.1.2.1.2.3 Identify the staff responsible for receipt and investigation of grievances;

7.1.2.1.2.4 Be posted in a public place;

7.1.2.1.3 Participate, and/or have others of his/her choice participate, in an informed way in the grievance process.

7.1.2.1.4 To be informed that participation in treatment is voluntary, except as provided in 16 Del.C. §§2211, 2212, 2213 and 2215;

7.1.2.1.5 To refuse service, except as provided in 16 Del.C. §§2211, 2212, 2213 and 2215. If consequences, such as termination from other services, may result from such refusal, that fact shall be:

7.1.2.1.5.1 Documented in the client’s file.

7.1.2.1.6 To be free of any exploitation or abuse by any program personnel or any member of the governing body.

7.1.2.1.7 To be assured that any incident of abuse; neglect or mistreatment will be reported in accordance with §5.1.4.4.1.16.

7.1.2.1.8 To communicate with legal counsel.

7.1.2.1.9 To confidentiality of all records, correspondence and information relating to assessment, diagnosis and treatment in accordance with 42 U.S.C. § 290dd-2, 42 CFR Part 2 and HIPAA 45 CFR parts 160 and 164.

7.1.2.1.10 To review his/her own records in accordance with 42 U.S.C. § 290dd-2, 42 CFR Part 2 and HIPAA 45 CFR parts 160 and 164.

7.1.2.1.11 Client request for review and a summary of the review if granted shall be documented in the client’s record.

7.1.2.2 Participation in experimental or research programs

7.1.2.2.1 No client shall participate in any experimental or research project without the full knowledge, understanding and written consent of that client (and/or legal guardian, when appropriate).

7.1.2.2.2 All experimental or research projects shall be conducted in full compliance with applicable state and federal laws, regulations and guidelines.

7.1.3 Barriers to treatment:

7.1.3.1 The program shall make reasonable modifications in policies, practices and procedures and/or provide assistive services to accommodate clients who are unable to participate in treatment due to language, cultural, literacy barriers or disabilities, unless doing so would fundamentally alter the nature of the services offered.

**History**
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *12 DE Reg. 464 (10/01/08)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*

##### **16 Del. Admin. Code § 6001-8.0** Standards Applicable to all Facilities and Programs {#sec-6001-8.0 omnilex-key=us-de-regs-official--title-16--6001-8.0}

8.1 Clinical records

8.1.1 Maintenance of client records

8.1.1.1 Programs shall:

8.1.1.1.1 Maintain a record for each client that is

8.1.1.1.1.1 Accurate,

8.1.1.1.1.2 Legible and

8.1.1.1.1.3 Signed by the staff member who provided the service.

8.1.1.1.2 Maintain a standardized client record-keeping system, with client records that are uniform in format and content;

8.1.1.1.3 Establish and maintain a system that permits easy identification of and access to individual client records by authorized program staff;

8.1.1.1.4 Comply fully with the provisions of 42 U.S.C. § 290dd-2 and 42 CFR Part 2 and HIPAA 45 CFR parts 160 and 164;

8.1.1.1.5 Update each record within twenty-four (24) hours of delivery of a service unless otherwise specified in these regulations.

8.1.1.2 Any program that discontinues operations, or is merged with, or acquired by another program is responsible for ensuring compliance with the requirements of 42 CFR § 2.19, and HIPAA 45 CFR parts 160 and 164 whichever is applicable. The program shall document in writing to the Division:

8.1.1.2.1 How it will adhere to 42 CFR § 2.19 and HIPAA 45 CFR parts 160 and 164 at the time it notifies the Division of the program closure in accordance with §4.10.5 of these regulations; and

8.1.1.2.2 How it will adhere to §8.0 of these regulations.

8.1.2 Content of Client records

8.1.2.1 A record shall be established for each client upon admission and shall include:

8.1.2.1.1 A Consent to Treatment form signed by the client and, if the client is a minor, the client’s parent or guardian, except as provided in 16 Del.C. §2210(b).

8.1.2.1.2 An up-to-date face sheet including the client’s:

8.1.2.1.2.1 Date of admission;

8.1.2.1.2.2 Name;

8.1.2.1.2.3 Address;

8.1.2.1.2.4 Telephone number;

8.1.2.1.2.5 Gender;

8.1.2.1.2.6 Date of birth;

8.1.2.1.2.7 The client’s significant medical history documenting:

8.1.2.1.2.7.1 Current medical conditions;

8.1.2.1.2.7.2 Any medications the client is currently prescribed;

8.1.2.1.2.7.3 Any medications the client is currently taking;

8.1.2.1.2.7.4 Allergies,

8.1.2.1.2.8 The name and telephone number of the person to contact in an emergency;

8.1.2.1.2.9 An attached Consent to Release Information form permitting the program to make that contact;

8.1.2.1.2.10 Name, address and telephone number of most recent primary care provider.

8.1.2.1.3 Appropriate Consent to Release Information forms.

8.1.2.1.4 Documentation, signed by the client:

8.1.2.1.4.1 Acknowledging receipt of the notice of clients' rights;

8.1.2.1.4.2 Acknowledging his/her understanding of the agency's agreement with the confidentiality requirements of §7.1.2.1.9;

8.1.2.1.4.3 Acknowledging receipt of the program's procedures when an emergency occurs outside of the program's hours of operation.

8.1.2.1.5 Copies of any laboratory reports and drug tests ordered by the program.

8.1.2.1.6 Informed consent regarding prescribed pharmacotherapy obtained from the client prior to delivery of the medication prescription.

8.1.2.1.7 Results of the client's diagnostic assessment, including the client's:

8.1.2.1.7.1 Mental health status;

8.1.2.1.7.2 Psychiatric history;

8.1.2.1.7.3 Medical history (including allergies);

8.1.2.1.7.4 Education;

8.1.2.1.7.5 Work history;

8.1.2.1.7.6 Criminal justice history;

8.1.2.1.7.7 Substance use history, including:

8.1.2.1.7.7.1 Types;

8.1.2.1.7.7.2 Quantity;

8.1.2.1.7.7.3 Route;

8.1.2.1.7.7.4 Frequency of substances used;

8.1.2.1.7.7.5 Age of first use;

8.1.2.1.7.7.6 Date of last use;

8.1.2.1.7.7.7 Duration and patterns of use, including:

8.1.2.1.7.7.7.1 Periods of abstinence;

8.1.2.1.7.8 Past supports and resources that were effective in previous recovery attempts;

8.1.2.1.7.9 Previous treatment episodes and type of discharge;

8.1.2.1.7.10 Reason(s) for seeking treatment;

8.1.2.1.7.11 Identification and evaluation of the client's needs;

8.1.2.1.7.12 History of other addictive disorders.

8.1.2.1.7.13 Family History including:

8.1.2.1.7.13.1 Psychiatric history;

8.1.2.1.7.13.2 Use of alcohol and other drugs by family members and significant others.

8.1.2.1.7.14 A diagnostic assessment summary of the client's status that addresses the client's:

8.1.2.1.7.14.1 strengths;

8.1.2.1.7.14.2 barriers to treatment; and

8.1.2.1.7.14.3 goals.

8.1.2.1.7.15 Indicates which what issues and areas of clinical concern are to be:

8.1.2.1.7.15.1 Treated;

8.1.2.1.7.15.2 Deferred; or

8.1.2.1.7.15.3 Referred.

8.1.2.1.7.16 Includes the client's:

8.1.2.1.7.16.1 Primary language;

8.1.2.1.7.16.2 Cultural background;

8.1.2.1.7.16.3 Attitudes toward alcohol and other drug use; and

8.1.2.1.7.16.4 Spiritual or religious beliefs.

8.1.2.1.7.17 The rationale for placement recommendations:

8.1.2.1.7.17.1 Signed by the Counselor completing the assessment;

8.1.2.1.7.17.2 Reviewed, as indicated by the signature of the clinical supervisor; and

8.1.2.1.7.17.3 Is completed prior to the development of the initial Recovery Plan.

8.1.2.1.7.18 Copies of all correspondence related to the client.

8.1.2.1.8 An individualized Recovery Plan, developed in partnership with the client, shall be completed no later than the time required in these regulations for the modality for which the program is licensed.

8.1.2.1.9 The recovery plan shall:

8.1.2.1.9.1 Identify the date the plan is to be effective;

8.1.2.1.9.2 Identify the client's:

8.1.2.1.9.2.1 Strengths;

8.1.2.1.9.2.2 Barriers to treatment; and

8.1.2.1.9.2.3 Goals.

8.1.2.1.9.3 Address the goals as derived from the assessment process:

8.1.2.1.9.3.1 To be treated.

8.1.2.1.9.3.2 Identify objectives that:

8.1.2.1.9.3.2.1 Address the goals;

8.1.2.1.9.3.2.2 Are specific;

8.1.2.1.9.3.2.3 Are measurable;

8.1.2.1.9.3.2.4 Are time limited; and

8.1.2.1.9.3.2.5 Specify the treatment regimen, including:

8.1.2.1.9.3.2.5.1 Which services and/or activities will be used to achieve each recovery plan objective;

8.1.2.1.9.3.2.5.2 The frequency of each service and/or activity to meet the goals/objectives;

8.1.2.1.9.3.2.5.3 Goals/objectives to be referred;

8.1.2.1.9.3.2.5.4 Goals/objectives to be deferred;

8.1.2.1.9.3.3 Be signed by:

8.1.2.1.9.3.3.1 The client;

8.1.2.1.9.3.3.2 The staff who developed the recovery plan; and

8.1.2.1.9.3.3.3 The clinical supervisor.

8.1.2.1.10 Periodic Recovery Plan Review/Revision

8.1.2.1.10.1 Recovery plans shall be reviewed and revised by the client and his/her counselor, and no less often than the intervals specified for the modality for which the program is licensed and shall address the issues remaining to be treated as derived from and recovery plan review.

8.1.2.1.11 Progress notes

8.1.2.1.11.1 Each contact made with or on behalf of the client in accordance with the interventions prescribed on the recovery plan shall be documented in the client file; and

8.1.2.1.11.1.1 Be written to include:

8.1.2.1.11.1.1.1 The type(s) of service provided;

8.1.2.1.11.1.1.2 The date of the service(s) provided;

8.1.2.1.11.1.1.3 The length of the service(s) provided; and

8.1.2.1.11.1.1.4 A description of the client's response to the session including:

8.1.2.1.11.1.1.4.1 Facts (a description of the service and/or activity and the client's participation in the service and/or activity);

8.1.2.1.11.1.1.4.2 Clinical impressions (the counselor 's assessment of the client's response or lack of response to the service and/or activity and the client's progress or lack of progress toward achieving the objectives prescribed in the recovery plan);

8.1.2.1.11.1.1.4.3 Plan for future sessions (anticipated implementation, by the counselor, of services and/or activities as prescribed in the recovery plan.)

8.1.2.1.12 Clinical Supervision

8.1.2.1.12.1 The clinical supervisor shall review each individual client record with the client's counselor as often as necessary, and in conjunction with recovery plan review and revision and no less often than at the intervals specified by each modality for which the program is licensed.

8.1.2.1.12.2 The clinical supervisor shall provide specific, written clinical recommendations on how to proceed with the case.

8.1.2.1.12.3 The clinical supervisor shall sign the recovery plan revision/review.

8.1.2.1.13 Discharge Plan

8.1.2.1.13.1 In anticipation of successful completion or planned interruption of a client's treatment, the treatment staff and client shall jointly develop a discharge plan.

8.1.2.1.14 Discharge Summary

8.1.2.1.14.1 For every client that is discharged, the program shall complete a discharge summary within seventy-two (72) hours of a planned discharge and within ninety-six (96) hours of an unplanned discharge.

8.1.2.1.14.2 The narrative discharge summary shall include the client's:

8.1.2.1.14.2.1 Name;

8.1.2.1.14.2.2 Discharge address;

8.1.2.1.14.2.3 Discharge telephone number;

8.1.2.1.14.2.4 Admission date;

8.1.2.1.14.2.5 Discharge date;

8.1.2.1.14.2.6 A summary of the client's progress toward treatment plan objectives;

8.1.2.1.14.2.7 A summary of the client's participation in treatment;

8.1.2.1.14.2.8 The reasons for discharge;

8.1.2.1.14.2.9 Any unresolved issues;

8.1.2.1.14.2.10 Recommendations regarding the need for additional treatment services.

8.1.2.1.14.3 When the discharge is planned, the discharge summary shall be signed by:

8.1.2.1.14.3.1 The client

8.1.2.1.14.3.2 The counselor, and

8.1.2.1.14.3.3 The clinical supervisor.

8.1.3 Programs shall provide a list of referral sources for the client’s various needs when the agency is unable to meet the client’s needs internally. The agency shall be responsible for assisting the client in enrolling in services at other agencies.

8.1.4 Programs shall provide a minimum of twelve (12) months of records up until and including the expiration date of the current license for the purposes of licensure audit. Programs shall develop a policy that clearly outlines timelines for record retention and storage for all records beyond the required audit period.

**History**
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *12 DE Reg. 464 (10/01/08)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*

##### **16 Del. Admin. Code § 6001-9.0** Standards Applicable to all Facilities and Programs {#sec-6001-9.0 omnilex-key=us-de-regs-official--title-16--6001-9.0}

9.1 Facility Standards

9.1.1 Unless otherwise specified programs shall be in compliance with the regulations in this section.

9.1.2 Each agency shall provide facilities that:

9.1.2.1 Provide privacy for communications between clients and staff members;

9.1.2.2 Provide waiting areas and meeting spaces that are welcoming to diverse populations and cultures;

9.1.2.3 Include rest rooms for clients, visitors and staff.

9.1.3 Agencies shall maintain up-to-date documentation verifying that they have a certificate of occupancy and meet applicable federal, state and local building, zoning, fire, and safety and accessibility requirements.

9.1.4 Agencies shall maintain facilities in neat and clean condition, and eliminate any hazardous conditions that endanger the health or safety of clients, visitors or staff.

9.1.5 Agencies shall not permit tobacco use in program facilities.

9.1.6 Agencies shall post a current fee schedule in a public place within the facility.

9.1.7 Agencies shall post hours of operation in a public place within the facility.

9.2 Fire Prevention and Safety

9.2.1 Agencies shall display up to date certificates or approval/inspection by Fire Department authorities whenever this is required/available in the specific community where the program is located.

9.3 Emergency policies and procedures.

9.3.1 Each agency shall establish a plan of action in the event of emergencies or disasters, based on the program’s capability and limitations. The plan shall include provisions:

9.3.1.1 For responding to severe weather, loss of power or water or other natural disaster;

9.3.1.2 For evacuation plans with specific primary and alternative evacuation routes;

9.3.1.3 For posting evacuation routes in areas visible to staff, clients and visitors;

9.3.1.4 For responding to accidents that result in injury or death;

9.3.1.5 Governing how available resources will be used to continue client care;

9.3.1.6 Governing how the program will effectively activate community resources to prevent or minimize the consequences of a disaster;

9.3.1.7 Concerning staff preparedness and the designation of roles and functions;

9.3.1.8 Concerning criteria for the cessation of nonessential services and client transfer determinations; and

9.3.1.9 Governing how it will protect the safety of clients and staff and the security of its records.

9.3.2 All treatment programs shall develop procedures for handling a client who is exhibiting behavior that is threatening to the life or safety of the client or others.

9.3.3 All treatment programs shall have a staff member on site at all times trained in:

9.3.3.1 Crisis intervention; and

9.3.3.2 The standard Red Cross first aid class and CPR certification, or its equivalent.

Part III--Provisions Regarding Modalities

**History**
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *12 DE Reg. 464 (10/01/08)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*

##### **16 Del. Admin. Code § 6001-10.0** Standards Applicable to Residential Detoxification {#sec-6001-10.0 omnilex-key=us-de-regs-official--title-16--6001-10.0}

10.1 Services Required:

10.1.1 In addition to the requirements applicable to all programs, a Medically Monitored Residential Detoxification program shall provide:

10.1.1.1 Meals in accordance with §12.3.

10.1.1.2 Housing in accordance with §12.4.

10.1.1.3 Admission assessment by qualified medical personnel or licensed nurse prior to admission to determine need for detoxification.

10.1.2 There shall be no administration of prescription or non-prescription drugs until qualified medical personnel have examined the client, or qualified medical personnel have been consulted.

10.1.3 Physical examination conducted by qualified medical personnel within twenty-four (24) hours of admission.

10.1.4 A medical care plan within twenty-four (24) hours of admission based on the findings of the physical examination in §10.1.3 and including:

10.1.4.1 A brief screening to identify:

10.1.4.1.1 Motivation for treatment;

10.1.4.1.2 Relapse potential;

10.1.4.1.3 Recovery environment at discharge.

10.1.5 Within Seventy-two (72) hours of admission, diagnostic assessment in accordance with §8.1.2.1.7.

10.1.6 Within seventy-two (72) hours of admission, recovery planning in accordance with §8.1.2.1.8.

10.1.7 Periodic recovery plan review/revision in accordance with §8.1.2.1.10.

10.1.7.1 By the seventh (7th) day, and

10.1.7.2 Every fifth (5th) day thereafter.

10.1.8 For those clients not medically restricted individual counseling that shall include at least one (1) (fifteen) 15 minute counseling contact per day with a Counselor I or Counselor II.

10.1.9 Group counseling that shall include at least one (1) sixty-minute (60) counseling session per day with a Counselor I or Counselor II.

10.1.10 Emergency medical and hospital services at a licensed hospital, as needed.

10.2 Required Additional Policies and Procedures

10.2.1 The program shall have protocols developed and supported by a physician knowledgeable in addiction medicine setting forth:

10.2.1.1 A medication policy that complies with §5.1.4.4.1.19.

10.2.1.2 The protocol staff should take to respond to medical complications throughout the detoxification process.

10.2.1.3 The circumstances under which medical intervention is required.

10.3 Operation, Staffing and Staff Schedules

10.3.1 The program shall operate seven (7) days per week, twenty-four (24) hours per day.

10.3.2 The program shall have written affiliation agreements for the provision of services required by this section, when those services are not provided in house.

10.3.3 A physician(s) shall provide on-site services as necessary and on-call services twenty-four (24) hours a day.

10.3.4 When clients are present, there shall be qualified medical personnel or a licensed nurse on site who has knowledge of the complications associated with withdrawal.

10.3.5 When clients are present, there shall be staff on duty and awake at all times.

10.3.6 A counselor shall be available on site to clients at least eight (8) hours a day, seven (7) days a week and available on call twenty-four (24) hours a day.

10.4 Monitoring and documenting the client’s condition

10.4.1 Upon admission, the program shall record:

10.4.1.1 Client’s blood pressure;

10.4.1.2 Client’s pulse;

10.4.1.3 Client’s respiration;

10.4.1.4 Presence of bruises, lacerations, cuts or wounds;

10.4.1.5 Any medications carried by the client or found on the client’s person.

10.4.1.6 Documentation, at a frequency prescribed by Qualified Medical Personnel, but no less than three times in the first eight hours after admission of:

10.4.1.6.1 Blood Pressure;

10.4.1.6.2 Pulse;

10.4.1.6.3 Respiration;

10.4.1.6.4 Type and amount of fluid intake;

10.4.1.6.5 Physical state, including the presence of tremors, ataxia, or excessive perspiration, restlessness, and sleep disturbances;

10.4.1.6.6 Mental state, including the presence of confusion, hallucinations, and orientation to person, place, and time;

10.4.1.6.7 Emotional state, including the presence of anxiety, depression.

**History**
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
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- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *12 DE Reg. 464 (10/01/08)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*

##### **16 Del. Admin. Code § 6001-11.0** Standards Applicable to Ambulatory Detoxification (Amdetox): {#sec-6001-11.0 omnilex-key=us-de-regs-official--title-16--6001-11.0}

In addition to these standards, all programs providing Amdetox services shall be in full compliance with Federal Regulations regarding the dispensing and handling of all medications used in the detoxification of substance use disorders.

11.1 Services Required

11.1.1 In addition to the requirements applicable to all programs, an Amdetox program shall provide:

11.1.1.1 An initial screening, documentation of which shall include:

11.1.1.1.1 Verification of an applicant's identity, including:

11.1.1.1.1.1 Name;

11.1.1.1.1.2 Address;

11.1.1.1.1.3 Date of birth; and

11.1.1.1.1.4 Photographic identification.

11.1.1.1.2 Determination of current physiologic dependence and/or history of dependence upon opium, morphine, heroin or any derivative or synthetic drug of that group, in accordance with DSM criteria, by medical examination performed by qualified medical personnel.

11.1.1.1.3 Determination of current physiologic dependence and/or history of dependence on alcohol or other substances known to result in physical dependence in accordance with DSM criteria.

11.1.1.1.3.1 Documentation to support that determination shall include:

11.1.1.1.3.1.1 Qualified medical personnel statement that treatment is medically necessary;

11.1.1.1.3.1.2 The five-axis DSM diagnosis (most current DSM edition);

11.1.1.1.3.1.3 A description of behavior(s) supportive of a diagnosis of dependence;

11.1.1.1.3.1.4 Determination of the duration of substance dependence.

11.1.1.1.3.2 A physical examination by qualified medical personnel that shall:

11.1.1.1.3.2.1 Include documentation of the client's general appearance with a focus on the clinical signs and symptoms of addiction;

11.1.1.1.3.2.2 Document vital signs;

11.1.1.1.3.2.3 Include a complete medical history;

11.1.1.1.3.2.4 Include the client's family medical history;

11.1.1.1.3.2.5 Include medications currently being taken; and

11.1.1.1.3.2.6 Completed at admission.

11.1.1.1.3.3 Determination by qualified medical personnel that the person's history and current symptomatology support Amdetox as the most appropriate level of care.

11.1.1.1.4 Laboratory tests including serology and other tests deemed necessary by the program physician.

11.1.1.1.5 A biological test for pregnancy for all women of child-bearing age.

11.1.1.1.6 HIV testing should be encouraged, with the client's signed consent.

11.1.1.2 A client enrolled in an Opioid Treatment program or another Amdetox program shall not be permitted to enroll in treatment in any other Amdetox program except in exceptional circumstances as determined by the medical director. Exceptions shall be:

11.1.1.2.1 Noted in the client's record.

11.2 Admission procedures

11.2.1 In addition to the procedures described in §8.1.2. Amdetox programs shall provide:

11.2.1.1 A medical care plan within twenty-four (24) hours of admission based on the findings of the physical examination in §11.1.1.1.3.2.

11.2.1.2 Diagnostic assessment in accordance with §8.1.2.1.7 within twenty-four (24) hours of admission.

11.2.1.2.1 An Initial Recovery Plan as derived by the diagnostic assessment in §11.2.1.7 of these standards and the medical care plan in §11.2.1.1 of these standards within twenty-four (24) hours of admission.

11.2.1.2.2 Recovery plan updates/revisions shall occur:

11.2.1.2.2.1 As needed based on the changes of intensity level of treatment for each client and:

11.2.1.2.2.1.1 No later than the seventh (7h) day; AND

11.2.1.2.2.1.2 Every seven (7) days thereafter.

11.2.1.3 Procedures for referral to a licensed hospital or residential detoxification program when a more or less intensive level of care is indicated.

11.3 Client Orientation

11.3.1 In addition to the requirements of §8.1.2.1.4 the Amdetox program shall inform clients of:

11.3.1.1 The facts concerning the use of buprenorphine, naltrexone, chlordiazepoxide or other detoxification medications dispensed by the program, including, but not limited to:

11.3.1.1.1 An explanation of the interaction between the detoxification medication(s) dispensed by the program and other medications, and medical procedures;

11.3.1.1.2 Any potential adverse reactions, including those resulting from interactions with other prescribed or over-the-counter pharmacological agents, other medical procedures; and

11.3.1.1.3 The importance of notifying the client's primary care physician of their admission to and discharge from the program.

11.3.1.2 The facts concerning withdrawal from the use of, buprenorphine, naltrexone, chlordiazepoxide or other detoxification medications dispensed by the program, including, but not limited to:

11.3.1.2.1 Policies and procedures regarding voluntary, involuntary, and against medical advice withdrawal from detoxification medications;

11.3.1.2.2 An explanation of the potential interaction between withdrawal from the detoxification medication(s) dispensed by the program and other medications, medical procedures and;

11.3.1.2.3 Any potential adverse reactions as a result of withdrawal from detoxification medications, including those resulting from interactions with other prescribed or over-the-counter pharmacological agents, other medical procedures; and

11.3.1.2.4 The importance of notifying the client's primary care physician of withdrawal from the program.

11.4 Clinical Services

11.4.1 In addition to the requirements of §8.0 the Amdetox program shall provide:

11.4.1.1 Individual counseling that shall include at least one (1) sixty (60) minute counseling session per week by a Counselor I or Counselor II.

11.4.1.2 Daily counseling contact by a Counselor I or Counselor II that shall include at a minimum:

11.4.1.2.1 One (1) fifteen (15) minute face-to-face or phone contact to:

11.4.1.2.1.1 Engage the client;

11.4.1.2.1.2 Help the client cope with withdrawal; and

11.4.1.2.1.3 Continue in ongoing treatment services.

11.4.1.2.2 Group Counseling that shall include at least two (2) ninety (90) minute counseling session per week.

11.4.1.2.3 The discharge plan outlined in §8.1.2.1.13 and discharge summary outlined in §8.1.2.1.14 of these standards.

11.4.1.2.4 Referral to a more or less intensive level of care as outlined in §8.1.3 of these standards.

11.5 Administrative Procedures

11.5.1 In addition to the requirements of §4.0 of these standards the Amdetox program shall develop policies and procedures that describe:

11.5.1.1 The program's medical/nursing monitoring schedule including:

11.5.1.1.1 Monitoring on the first day to determine the response to detoxification medication;

11.5.1.1.2 Monitoring of vital signs throughout the detoxification process;

11.5.1.1.3 Monitoring of symptom history within the most recent 24 hours.

11.5.1.2 The program's drug-screening procedure;

11.5.1.3 The program's Amdetox medication dispensing procedure;

11.5.1.4 The program's rules including non-compliance, and discharge procedures, to include:

11.5.1.4.1 Administrative detoxification medication withdrawal;

11.5.1.4.2 The signs and symptoms of overdose; and

11.5.1.4.3 When to seek emergency assistance.

11.5.1.5 The emergency procedures maintained by the program as required in §5.1.4.4.1.21 shall be available whenever clients are present at the program.

11.5.1.6 The program shall have protocols developed and supported by a physician knowledgeable in addiction medicine setting forth:

11.5.1.6.1 The requirement for qualified staff to obtain waivers allowing qualified physicians to dispense or prescribe specifically approved Schedule III, IV, and V narcotic medications for the treatment of Opioid addiction in treatment settings other than the traditional Opioid Treatment Program (i.e., methadone clinic) in accordance with the Drug Addiction Treatment Act of 2000 (DATA 2000.)

11.5.1.6.2 A medication policy that complies with §5.1.4.4.1.19 and includes:

11.5.1.6.2.1 Induction protocols and policies for:

11.5.1.6.2.1.1 Day one (1) and day two (2) of Opioid detoxification;

11.5.1.6.2.1.2 Day three (3) of Opioid detoxification and forward.

11.5.1.6.2.2 Induction protocols and policies for all other medications used in detoxification.

11.5.1.6.2.3 Stabilization that includes:

11.5.1.6.2.3.1 Documentation and rationale for changes in medication dosage;

11.5.1.6.2.3.2 Average length of stay criteria; and

11.5.1.6.2.3.3 Criteria for linkage to outpatient treatment.

11.5.1.6.2.4 Protocols for the decrease and/or discontinuance of detoxification medications to include:

11.5.1.6.2.4.1 Protocols for decreasing or discontinuing detoxification meds when the client requests;

11.5.1.6.2.4.2 Protocols for decreasing or discontinuing when the program determines that maximum benefit has been achieved; and

11.5.1.6.2.4.3 Protocols for decreasing or discontinuing when being administratively discharged or if the client chooses no further treatment.

11.5.1.6.2.5 The protocol staff should follow to respond to medical complications throughout the detoxification process.

**History**
- *14 DE Reg. 471 (11/01/10)*
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- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *12 DE Reg. 464 (10/01/08)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*

##### **16 Del. Admin. Code § 6001-12.0** Residential Treatment {#sec-6001-12.0 omnilex-key=us-de-regs-official--title-16--6001-12.0}

12.1 Services Required

12.1.1 In addition to the requirements applicable to all programs, a Residential Treatment program shall provide:

12.1.1.1 Medical assessment by qualified medical personnel on the day of admission.

12.1.1.2 A physical examination in accordance with §8.1.2.1.2.1.7 within seventy-two (72) hours of admission, unless the client presents a copy of a physical examination completed by qualified medical personnel within ninety (90) days prior to admission.

12.1.1.3 A TB test and urine drug screen within seventy-two (72) hours of admission or documentation of a TB test performed within one (1) year prior to admission.

12.1.1.4 RESERVED

12.1.1.5 Diagnostic assessment in accordance with 8.1.2.1.7 within forty-eight (48) hours of admission.

12.1.1.6 The recovery plan required by §8.1.2.1.8 within seventy-two (72) hours of admission.

12.1.1.7 Recovery plan review/revision and update in accordance with §8.1.2.1.10 as needed based on changes in functioning for each client and at a minimum:

12.1.1.7.1 On the thirtieth (30) day; and

12.1.1.7.2 Every thirty (30) days thereafter.

12.2 Hours of Operation, Staffing and Staff Schedules

12.2.1 Residential programs shall operate twenty-four (24) hours per day, seven (7) days per week.

12.2.2 There shall be staff on duty and awake at all times.

12.2.3 A counselor shall be on site at least eight (8) hours a day, seven (7) days a week and available on call twenty-four (24) hours a day.

12.2.4 Counselor I and Counselor II shall meet face-to-face with clinical supervisors a minimum of one (1) hour per Counselor per week for clinical supervision.

12.3 Nutritional Services

12.3.1 Programs shall establish a written plan for meeting the basic nutritional needs, as well as any special dietetic needs, of clients. Plans shall:

12.3.1.1 Include a varied and nutritious diet of at least three (3) meals a day, seven (7) days per week;

12.3.1.2 Include snacks as part of the overall dietary plan;

12.3.1.3 Include food substitutions, (as applicable);

12.3.1.4 Be reviewed by a registered dietitian annually and when they are changed.

12.4 Facility Standards

12.4.1 All residential programs shall provide:

12.4.1.1 Separation of sleeping quarters serving male and female clients;

12.4.1.2 Separation of bathroom facilities serving male and female clients;

12.4.1.3 Privacy for personal hygiene;

12.4.1.4 Secure closet and storage space for clients’ personal property;

12.4.1.5 Security for valuables, including an inventory and receipt system;

12.4.1.6 Laundry facilities for clients; and

12.4.1.7 Space for solitude.

12.4.2 All agencies operating residential programs shall ensure that in addition to the clients’ rights enumerated in §7.0, these additional clients’ rights are fully protected:

12.4.2.1 The right to visitation with family and friends, subject to written visiting rules and hours established by the program, except as provided in this subsection.

12.4.2.2 The right to conduct private telephone conversations, subject to written rules and hours established by the program, except as provided in this subsection.

12.4.2.2.1 The Administrator or designee may impose limitations on any of the, visitation and/or phone call procedures when in the judgment of the Administrator, such limitations are therapeutically necessary. Limitations shall be recorded in the client’s record.

12.4.2.3 The right to send and receive uncensored and unopened mail. Program may require the client to open mail or package(s) in the presence of program staff for inspection.

12.4.2.4 The right to wear his/her own clothing subject to written program rules.

12.4.2.5 The right to bring personal belongings, subject to limitation or supervision by the program.

12.4.2.6 The right to communicate with their personal physician.

12.4.2.7 The right to practice their personal religion or attend religious services, within the program’s policies and written policies for attendance at outside religious services.

**History**
- *14 DE Reg. 471 (11/01/10)*
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- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *12 DE Reg. 464 (10/01/08)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*

##### **16 Del. Admin. Code § 6001-13.0** Transitional residential treatment {#sec-6001-13.0 omnilex-key=us-de-regs-official--title-16--6001-13.0}

13.1 Services Required

13.1.1 In addition to the requirements applicable to all programs, a Transitional residential treatment program shall provide:

13.1.1.1 Meals in accordance with §12.3.

13.1.1.2 Housing in accordance with §12.4.

13.1.1.3 Physical examination by qualified medical personnel within seventy-two (72) hours of admission unless the client has had a physical examination completed by qualified medical personnel within ninety-days (90) prior to admission.

13.1.1.4 Within seven (7) days of admission, diagnostic assessment in accordance with §8.1.2.1.7.

13.1.1.5 Within seven (7) days of admission, recovery planning in accordance with §8.1.2.1.8.

13.1.1.6 Recovery plan review/revision in accordance with §8.1.2.1.9 as needed based on changes in functioning for each client and at a minimum:

13.1.1.6.1 Every thirty (30) days.

13.1.1.7 Medical evaluation and consultation by a licensed physician, as needed.

13.1.1.8 Emergency medical and hospital services at a licensed hospital, as needed.

13.1.2 Operation, Staffing and Staff Schedules

13.1.2.1 The program shall operate twenty-four (24) hours per day, seven (7) days per week.

13.1.2.2 The program shall have written affiliation agreements for the provision of services required by the recovery plan in §8.1.2.1.9.3.2.5.3 of these standards, when these services are not provided in house.

13.1.2.3 When clients are present, there shall be staff on site and on duty at all times.

13.1.2.4 A Counselor shall be available to clients twenty-four (24) hours a day, seven (7) days per week.

**History**
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
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- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *12 DE Reg. 464 (10/01/08)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*

##### **16 Del. Admin. Code § 6001-14.0** Opioid Treatment Services: {#sec-6001-14.0 omnilex-key=us-de-regs-official--title-16--6001-14.0}

In addition to these standards, all programs providing Opioid treatment services shall be in full compliance with Federal Regulations regarding Opioid treatment.

14.1 Admission procedures in addition to the admission procedures described in §8.1.2:

14.1.1 If an applicant for Opioid treatment services has been discharged within seven (7) years from treatment at another OTP, the admitting program shall document that a good faith effort was made to review whether or not the client is enrolled in any other OTP.

14.1.2 A client enrolled in another program shall not be permitted to enroll in treatment in any other OTP except in exceptional circumstances as determined by the medical director. Exceptions shall be:

14.1.2.1 Noted in the client's record.

14.2 Special admission populations (where the absence of physiological dependence shall not be an exclusion criterion with a clinically justifiable admission) shall include:

14.2.1 Persons recently released from a penal institution; (within six (6) months after release.)

14.2.2 Pregnant clients; (Program physician shall certify pregnancy)

14.2.3 Previously treated clients; (Up to two (2) years after discharge)

14.2.4 Adolescents, provided that:

14.2.4.1 Individuals under the age of 18 have had two documented attempts at short-term medically supervised withdrawal (detoxification) or drug-free treatment to be eligible for maintenance treatment;

14.2.4.2 In addition to the consent of the client, Individuals under 18 years old, unless otherwise permitted by 16 Del.C. §2210 to consent to treatment, have had a parent or legal guardian complete and sign the agency's consent to OTP Treatment.

14.3 Client Orientation

14.3.1 In addition to the requirements of §8.1.2.1.4 OTPs shall inform clients of:

14.3.1.1 The facts concerning the use of methadone, buprenorphrine, or other Opioid treatment medications dispensed by the program, including, but not limited to:

14.3.1.1.1 An explanation of the interaction between the Opioid treatment medication(s) dispensed by the program and other medications, medical procedures and food;

14.3.1.1.2 Any potential adverse reactions, including those resulting from interactions with other prescribed or over-the-counter pharmacological agents, other medical procedures and food; and

14.3.1.1.3 The importance of notifying the client's primary care physician of their admission to and discharge from the program;

14.3.1.1.4 The facts concerning the withdrawal from the use of methadone, buprenorphrine, or other Opioid treatment medications dispensed by the program, including, but not limited to:

14.3.1.1.5 Policies and procedures regarding voluntary, involuntary, and against medical advice withdrawal from Opioid treatment medications;

14.3.1.1.6 An explanation of the potential interaction between withdrawal from the Opioid treatment medication(s) dispensed by the program and other medications, and medical procedures;

14.3.1.1.7 Any potential adverse reactions as a result of withdrawal from Opioid treatment medications, including those resulting from interactions with other prescribed or over-the-counter pharmacological agents, other medical procedures; and

14.3.1.1.8 The importance of notifying the client's primary care physician of withdrawal from the program.

14.3.1.2 The program's drug-screening procedure;

14.3.1.3 The program's Opioid treatment medication dispensing procedure, including the days and hours of operation;

14.3.1.4 The program's rules including non-compliance, and discharge procedures, to include administrative Opioid treatment medication withdrawal;

14.3.1.5 The signs and symptoms of overdose and when to seek emergency assistance;

14.3.1.6 The emergency procedures maintained by the program as required in §5.1.4.4.1.21 shall be available twenty-four (24) hours per day.

14.3.1.7 Safe storage practices for take-home Opioid treatment medications;

14.3.1.8 The financial aspects of treatment, including the consequences of nonpayment of required fees.

14.3.2 Upon admission, the program shall obtain from or issue to each client a photo identification card.

14.4 Client Re-admissions

14.4.1 A client re-admitted to the same program within thirty (30) days need not receive a medical examination and laboratory tests if s/he received a medical examination and laboratory tests within the previous year.

14.5 Hours of Operation, Staffing, and Staff Orientation

14.5.1 OTPs shall operate six (6) days per week, with at least two (2) hours of medicating time accessible daily outside the hours of 8 a.m. to 5 p.m. Monday through Friday, and three (3) hours on Saturday or Sunday.

14.5.2 Each OTP shall post medication dispensing and counseling hours in a public place within the facility.

14.5.3 Each OTP shall have the services of licensed medical personnel including:

14.5.3.1 A designated medical director, who is a physician, responsible for the administration of all medical services performed by the program and for compliance with all federal, state and local laws, rules and regulations regarding medical treatment of narcotic dependence;

14.5.3.2 At all times when the clinic is open, if a physician is not on site, a physician shall be available for consultations and emergency attendance;

14.5.3.3 Prior to services delivery, in addition to training requirements in §5.1.7.1, OTPs shall provide new staff orientation, including:

14.5.3.3.1 Clinical and pharmacotherapy issues,

14.5.3.3.2 Overdose, and other emergency procedures,

14.5.3.3.3 Provision of services to special populations such as adolescents, pregnant women, and senior citizens.

14.6 Administration of Opioid treatment medication

14.6.1 No dose of Opioid treatment medication shall be administered until the client has been identified and the dosage compared with the currently ordered and documented dosage level.

14.6.2 Only a licensed professional authorized by law may administer or dispense Opioid treatment medication.

14.6.3 Ingestion shall be observed and verified by the personnel authorized to administer the Opioid treatment medication.

14.6.4 There shall be only one client in the dispensing area at a time.

14.6.5 A physician shall obtain a detailed history of drug use within the last twenty-four (24) hours prior to initial dose, and,

14.6.5.1 Determine the client's initial dosage after a physical examination;

14.6.5.2 The initial dose of Methadone shall not exceed thirty (30) mg.;

14.6.5.3 Additional medication shall not be administered, unless:

14.6.5.3.1 After three (3) hours of observation, the physician documents in the client's record that the initial dose did not suppress opiate abstinence symptoms; and

14.6.5.3.2 The physician writes orders for additional medication.

14.6.5.4 The initial total daily dose of methadone for the first day shall not exceed forty (40) mg., unless the physician documents justification for a higher dosage in the client record that forty (40) mg did not suppress opiate abstinence symptoms.

14.6.5.5 The initial dose of any other Opioid treatment medications shall not exceed federal regulations, guidelines or medical protocol.

14.6.5.6 The program physician shall justify any deviations from dosages, frequencies, and conditions of usage described in the approved product labeling.

14.6.5.7 Qualified medical personnel shall determine all subsequent dosage levels and shall:

14.6.5.7.1 Document each order change on the physician's medication orders;

14.6.5.7.2 Sign each order change; and

14.6.5.7.3 Date the order.

14.6.5.8 Programs shall dispense methadone in an oral form, in accordance with federal and state law and regulations in containers conforming to 42 CFR (Part VIII) Section 12.(i)(5). .

14.6.5.9 Any Opioid treatment medication error or adverse drug reaction shall be reported promptly to the medical director and an entry made in the client's record.

14.6.5.10 The medical director shall ensure that significant adverse drug reactions are reported to the Federal Food and Drug Administration and to the manufacturer in a manner that does not violate the client's confidentiality.

14.6.5.11 Each program shall develop a written emergency procedure to be implemented in the case of an employee strike, fire or other emergency situation that would stop or substantially interfere with normal dispensing operations. The emergency procedure shall comply with 9.3 and also include:

14.6.5.12 Arrangements with a security provider for immediate security of Opioid treatment medications;

14.6.5.13 Written agreements, updated annually, with back-up licensed professionals authorized by law, for the coverage of dispensing and other medical needs if regular personnel are not available;

14.6.5.14 A reliable system for confirming the identities of clients before dispensing; and

14.6.5.15 Written agreements, updated annually, for the use of an alternate program, hospital or other site for dispensing during an emergency period.

14.7 Opioid treatment medication schedules; Unsupervised or "take-home use":

14.7.1 Treatment program decisions on dispensing unsupervised or "take-home" medications shall be determined by the medical director. The medical director shall consider the following criteria to determine whether a patient is responsible in handling drugs for unsupervised use:

14.7.1.1 Regularity of program attendance;

14.7.1.2 Absence of recent abuse of drugs, including alcohol;

14.7.1.3 Regularity of clinic attendance;

14.7.1.4 Absence of serious behavioral problems at the clinic.

14.7.1.5 Absence of known recent criminal activity (e.g. drug and drug related arrests, etc…)

14.7.1.6 Progress in meeting treatment plan goals;

14.7.1.7 Length of time in treatment;

14.7.1.8 Responsibility in the handling, and plan for the safe storage, of take home Opioid treatment medications;

14.7.1.9 Stability of the client's home environment and social relationships.

14.7.1.10 When it is determined that a patient is responsible in handling Opioid drugs, the Federal Regulations for take home privileges shall be applied.

14.7.1.11 OTPs shall maintain current procedures adequate to identify the theft or diversion of take-home medications, including:

14.7.1.11.1 labeling containers with the OTP's name, address, and telephone number; and

14.7.1.11.2 requiring patients to come to the clinic on a randomly scheduled basis for drug testing and checking the amount of take-home medication used to that point.

14.7.1.12 Programs shall also ensure that take-home supplies are packaged in a manner that is designed to reduce the risk of accidental ingestion, including child-proof containers.

14.8 Revocation of take-home privileges.

14.8.1 The program medical director will determine if a client's conduct warrants revocation or suspension of take-home privileges.

14.8.2 Documentation of the rationale for revoking or suspending take-home privileges will be entered into the client's record by the medical director.

14.9 Exceptions.

14.9.1 If, in the judgment of the program physician:

14.9.1.1 A client has a physical disability that interferes with his or her ability to conform to the applicable mandatory attendance schedule, the program physician may permit a reduced attendance schedule.

14.9.1.2 A client is unable to conform to the applicable mandatory attendance schedule because of exceptional circumstances such as illness, personal or family crises, travel, or other hardship, the program physician may permit a temporarily reduced schedule, provided that the client is responsible in handling Opioid treatment medications. In such cases, the program physician shall record or verify the rationale for the exception in the client's record and date and sign the record. No client may receive more than a two (2) week supply of Opioid treatment medication at any one time.

14.9.1.3 Employed clients may apply for an exception to these requirements if the dispensing hours of the clinic conflict with working hours of the client. In such cases, the client may receive take-home medications after verifying work hours through reliable means, provided that the physician documents reasons for permitting take home medication.

14.9.1.4 Any client who transfers from one (1) OTP to another shall be eligible for placement on the same take-home schedule. Before initiating take-home privileges for a client transferring from other maintenance treatment programs, the program physician shall document reasons for permitting take home medication.

14.10 Voluntary Medical withdrawal from Opioid treatment Medication

14.10.1 Voluntary medical withdraw from Opioid treatment medication shall include:

14.10.1.1 A request signed and dated by the client, for voluntary medication withdrawal.

14.10.1.2 Documentation of the physician's rationale for initiation of withdrawal.

14.10.1.3 Documentation of the physician's rationale for continuing the withdrawal if there is any change in the physician's orders.

14.10.1.4 Documentation signed and dated by the client that the withdrawal will be discontinued and maintenance resumed at the client's request.

14.10.1.5 A biological test for pregnancy for all women of child-bearing age prior to the initiation of withdrawal.

14.10.1.6 Revision of the treatment plan with an increase in counseling and other support services in relation to medication dosage changes.

14.10.1.7 Provisions for continuing care after the last dose of Opioid treatment medication.

14.11 Withdrawal against medical advice

14.11.1 Withdrawal against medical advice shall include:

14.11.1.1 Documentation of all efforts taken by staff members to discourage initiation and continuation of withdrawal against medical advice.

14.11.1.2 Documentation of the reasons the client is seeking withdrawal against medical advice.

14.11.2 Involuntary withdrawal:

14.11.2.1 Involuntary withdrawal from an Opioid treatment medication shall be conducted in accordance with a dosage reduction schedule prescribed by the physician.

14.11.2.2 Clients being involuntarily discharged shall be referred to other treatment, as clinically indicated.

14.11.2.3 OTPs shall document the reasons for initiation of involuntarily withdrawal in the client's record.

14.11.2.4 Prior to the beginning of involuntary withdrawal, efforts should be documented regarding referral or transfer of the client to a suitable, alternative treatment program.

14.11.2.5 Involuntary withdrawal shall be considered a planned discharge and shall comply with §8.6 regarding the planned discharge of a client.

14.11.2.6 Documentation during withdrawal shall include:

14.11.2.6.1 Documentation by the physician of the schedule for withdrawal and any changes made to the schedule by the physician during the withdrawal.

14.11.2.6.2 Counseling designed to promote the continuation of services following medical withdrawal.

14.11.3 Detoxification treatment

14.11.3.1 An OTP shall maintain procedures that are designed to ensure that qualified medical personnel admit clients to short- or long-term detoxification treatment.

14.11.3.2 Patients with two or more unsuccessful detoxification episodes within a twelve (12) month period shall be assessed by the OTP physician for other forms of treatment.

14.11.3.3 A program shall not admit a client for more than two (2) detoxification treatment episodes in one year.

14.11.4 Pregnant Clients

14.11.4.1 In addition to the other requirements of this section, for pregnant clients the following shall apply:

14.11.4.1.1 OTPs shall provide priority in initiating treatment.

14.11.4.1.2 The physician shall document in the client record all clinical findings supporting the certification of the pregnancy prior to the administration of an initial dose of Opioid treatment medication.

14.11.4.1.3 The initial dose of Methadone shall not exceed 40 mg.

14.11.4.1.4 The program physician shall evaluate dosing of pregnant women weekly during the last trimester of the pregnancy.

14.11.4.1.5 If there is simultaneous use of alcohol and/or other drugs the program shall document:

14.11.4.1.5.1 Education of the client regarding the potential impact of substance use on the fetus.

14.11.4.1.5.2 Attempts to encourage the client to cease use of substances other than those prescribed by a physician.

14.11.4.1.5.3 Referrals made to appropriate levels of care.

14.11.4.1.6 Pregnant clients shall be given the opportunity for prenatal care either by the program or by referral to appropriate health care providers.

14.11.4.1.7 The program shall document all attempts to assist the client with obtaining prenatal care.

14.11.4.1.8 The program shall offer prenatal instruction on:

14.11.4.1.8.1 Education on fetal development;

14.11.4.1.8.2 Care for the newborn;

14.11.4.1.8.3 Breastfeeding;

14.11.4.1.8.4 Effects of maternal drug use on the fetus;

14.11.4.1.8.5 Information on parenting;

14.11.4.1.8.6 Importance of sound maternal nutritional practices.

14.11.4.2 OTP's shall give priority to pregnant women seeking admission to treatment.

14.11.4.3 OTP's shall maintain current policies and procedures that reflect the special needs of patients who are pregnant. Prenatal and other gender specific services shall be provided either by the OTP or by referral to appropriate health care providers.

14.11.4.4 Medical withdrawal of the pregnant, Opioid - addicted woman from Opioid treatment medication is not indicated or recommended. No pregnant client shall be involuntarily medically withdrawn from an Opioid treatment medication.

14.11.4.5 Pregnant individuals who choose to withdraw from treatment against medical advice shall do so under the direct supervision of the program physician in conjunction with an obstetrician who can monitor the effects on the fetus.

14.11.4.6 If a pregnant client refuses direct treatment, referral for treatment, or referral for other services, the program physician shall have the client acknowledge said refusal in writing. Documentation of the refusal shall be recorded in the client's record.

14.11.4.7 The program physician shall request the physician, hospital, or program to which the individual is referred, to provide reports of prenatal care, and a summary of the delivery and treatment outcome for the client and baby. Documentation of the request(s) shall be included in the client's record.

14.11.4.8 Within three (3) months after termination of the pregnancy, the program physician shall evaluate the individual's treatment status and document whether she should remain in the comprehensive maintenance program or be detoxified.

14.12 Accreditation

14.12.1 Programs shall be accredited by an accreditation body approved by The Substance Abuse and Mental Health Services Administration (SAMSHA) and registered with the Drug Enforcement Agency (DEA), as required.

**History**
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *12 DE Reg. 464 (10/01/08)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*

##### **16 Del. Admin. Code § 6001-15.0** Outpatient Treatment {#sec-6001-15.0 omnilex-key=us-de-regs-official--title-16--6001-15.0}

15.1 Services Required

15.1.1 In addition to the requirements applicable to all programs, an Outpatient Treatment program shall provide:

15.1.1.1 Documentation of a physical examination by qualified medical personnel within ninety (90) days prior to admission.

15.1.1.1.1 When documentation of a physical examination by qualified medical staff is not made available to the program, the program shall document a good faith effort in referring the client for a physical and/or efforts made to obtain documentation of a physical.

15.1.1.2 Diagnostic assessment in accordance with §8.1.2.1.7 within thirty (30) days of admission.

15.1.1.3 Recovery planning in accordance with §8.1.2.1.8 within thirty (30) days of admission or by the fourth (4th) counseling session, whichever occurs first.

15.1.1.4 Recovery plan review/revision in accordance with 8.1.2.1.10 as needed based on changes in functioning for each client and at a minimum:

15.1.1.4.1 Every ninety (90) days after the effective date of the first treatment plan.

15.2 Any time that services are offered at locations other than the program's main building, the program will assure that all requirements of §9.0 of these regulations are met in full.

**History**
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *12 DE Reg. 464 (10/01/08)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*

##### **16 Del. Admin. Code § 6001-16.0** Co-Occurring Treatment {#sec-6001-16.0 omnilex-key=us-de-regs-official--title-16--6001-16.0}

16.1 In addition to the requirements applicable to all programs and §15.0 of these standards, a Co-Occurring Treatment program shall provide a cadre of staff and services to meet the psychiatric and substance use disorder needs of clients. Staffing shall be flexible and meet the changing needs of the population served.

16.2 Staffing

16.2.1 Qualifications for the Position of Medical Director

16.2.1.1 Each Medical Director shall be a person with a Medical Degree or Doctor of Osteopathy degree; licensed to practice medicine in the state of Delaware and has completed (or is enrolled in) an accredited residency training program in psychiatry, internal medicine or family practice.

16.2.2 Qualifications for the Position of Qualified Psychiatric Practitioner

16.2.2.1 Qualified Psychiatric Practitioners shall meet the criteria for Qualified Medical Personnel as defined in §3.0 of these standards; AND

16.2.2.2 Have a minimum of three (3) years of documented clinical experience in the field of mental health.

16.2.3 Qualifications for the Position of Clinical Director

16.2.3.1 Each individual hired or promoted to provide clinical supervision on or after the date these regulations become effective shall, at a minimum, meet the following criteria:

16.2.3.1.1 A master's degree with a major in psychology, social work, counseling, nursing or a related field of study and six (6) years of clinical experience in human services, three (3) of which shall be in substance abuse treatment services; OR

16.2.3.1.2 A master's degree from an accredited college or university with a major in chemical dependency, psychology, social work, counseling, nursing or a related field of study and full certification as a Certified Co-Occurring Disorders Professional in the state of Delaware (CCDP); OR

16.2.3.1.3 A master's degree from an accredited college or university with a major in chemical dependency, psychology, social work, counseling, nursing or a related field of study and full certification as a Certified Co-Occurring Disorders Professional by a nationally recognized body.

16.2.3.2 Clinical supervisor as defined in §6.1.3 will not meet the criteria for Clinical supervisor for a co-occurring treatment program.

16.2.4 Qualifications for the Position of Mental Health Clinician

16.2.4.1 Each individual hired or promoted to the position of Mental Health Clinician on or after the date these regulations become effective shall meet the following criteria at a minimum:

16.2.4.1.1 A master's degree in psychology, counseling, social work, nursing, rehabilitation or related field of study from an accredited college or university.

16.2.5 Qualifications for the Position of Associate Mental Health Clinician:

16.2.5.1 Each individual hired or promoted to the position of Associate Mental Health Clinician on or after the date these regulations become effective shall, at a minimum, meet the following criteria:

16.2.5.1.1 Full certification as a Certified Co-Occurring Disorders Professional in the state of Delaware (CCDP); OR

16.2.5.1.2 Full certification as a Certified Co-Occurring Disorders Professional by a nationally recognized body; OR

16.2.5.1.3 A bachelor's degree from an accredited college or university in psychology, social work, counseling, or nursing and five (5) years of documented clinical experience working in the field of mental health

16.2.6 Qualifications for the position of Case Manager

16.2.6.1 Co-occurring treatment programs that employ Case Managers shall hire or promote staff on or after the date these regulations become effective that meet the following criteria:

16.2.6.1.1 A bachelor's degree from an accredited college or university in chemical dependency, psychology, social work, counseling, or nursing and five (5) years of documented clinical experience working in the field of mental health and/or addictions counseling.

16.2.6.2 Qualifications for the position of Assistant Clinician:

16.2.6.2.1 Each individual hired or promoted to the position of Assistant Clinician on or after the date these regulations become effective shall meet the following criteria:

16.2.6.2.1.1 A bachelor's degree from an accredited college or university in psychology, social work, counseling or nurse with less than five (5) years of documented clinical experience working in the field of mental health counseling; OR

16.2.6.2.1.2 The individual is a student enrolled in a course of study while completing a practicum or internship.

16.2.7 Programs may employ staff that dually meets the staffing requirements in §6.0 and §16.1 of these standards with the exception of §16.1.3: Clinical supervisor.

16.3 Staff Training

16.3.1 In addition to staff training and development in §5.1.7 of these standards, co-occurring treatment programs shall include:

16.3.1.1 At orientation:

16.3.1.1.1 Training in the relationship between substance use disorders and mental health disorders;

16.3.1.1.2 Training in the use of medication with co-occurring disorder clients including the use of buphrenorphine, and other Opioid antagonist medications; and

16.3.1.1.3 Training in DSM five (5) Axis Diagnosis.

16.3.1.2 Annually thereafter:

16.3.1.2.1 Ten (10) hours of training specific to the treatment of clients with co-occurring mental health and substance use disorders.

16.3.1.2.2 Ongoing training specific to co-occurring disorder treatment as part of the staff member's individualized training plan required in §5.1.7.2 of these standards.

16.4 Clinical Supervision

16.4.1 Staff who meet the criteria for Assistant Clinician in §16.1.6.2 of these standards shall receive clinical supervision in accordance with §6.1.5.2 and §6.1.5.3 of these standards.

16.5 Services

16.5.1 Qualified Psychiatric Practitioner

16.5.1.1 Qualified Psychiatric Practitioners shall be available to staff at all times.

16.5.1.2 Qualified Psychiatric Practitioners shall conduct a psychiatric evaluation within thirty (30) days of admission to the co-occurring treatment program to include:

16.5.1.2.1 Psychiatric history;

16.5.1.2.2 Medication history ;

16.5.1.2.3 Mental Status; AND

16.5.1.2.4 DSM five (5) Axis Diagnosis.

16.5.1.3 Qualified Psychiatric Practitioners shall meet with consumers for regularly scheduled appointments at intervals determined to be most beneficial for the consumer, but no less than every six months.

16.5.2 Medication monitoring

16.5.2.1 A Qualified Psychiatric Practitioner will explain to the consumer the rationale for each medication prescribed as well as the medication's risks/benefits.

16.5.2.1.1 Informed consent shall be obtained for each medication prescribed at the time it is prescribed.

16.5.2.1.2 Informed consent shall be updated, at a minimum, annually in concert with the annual psychiatric evaluation.

16.5.2.2 Rationale for all changes in medication orders shall be documented in the Qualified Psychiatric Practitioner's notes.

16.5.2.3 All medication orders in the consumer's case record shall include:

16.5.2.3.1 Name of the medication;

16.5.2.3.2 Dosage;

16.5.2.3.3 Route of administration;

16.5.2.3.4 Frequency of administration;

16.5.2.3.5 Signature of the Qualified Psychiatric Practitioner prescribing the medication; and

16.5.2.3.6 All known allergies.

16.5.2.4 Medication orders shall be documented on a medication order form and include:

16.5.2.4.1 Date of initiation;

16.5.2.4.2 Date of discontinuance;

16.5.2.4.3 Name of medication;

16.5.2.4.4 Route of administration;

16.5.2.4.5 Frequency of administration; AND

16.5.2.4.6 Signature of the person documenting the orders.

16.5.2.5 All medication orders shall be reviewed at each face-to-face meeting with the consumer and the review shall be reflected in the progress notes written by a Qualified Psychiatric Practitioner at the time of the consumer's visit.

16.5.3 A Qualified Psychiatric Practitioner's progress note shall be completed after each meeting with a consumer and include but not be limited to:

16.5.3.1 The consumer's report of progress;

16.5.3.2 The content of the meeting;

16.5.3.3 The Qualified Psychiatric Practitioner opinion of the consumer's status;

16.5.3.4 Current DSM five (5) Axis Diagnosis; AND

16.5.3.5 Continuation of the plan of treatment in conjunction with the consumer's treatment plan.

16.5.4 Annual review by Qualified Psychiatric Practitioner

16.5.4.1 Qualified Psychiatric Practitioner shall review each consumer's record annually and provide documentation of:

16.5.4.1.1 A clinical review of the consumer's progress over the year;

16.5.4.1.2 Any changes noted;

16.5.4.1.3 Mental status exam;

16.5.4.1.4 Observations;

16.5.4.1.5 Impressions;

16.5.4.1.6 DSM five (5) Axis Diagnosis; AND

16.5.4.1.7 Plan.

16.5.5 Staff shall monitor and document consumer tolerance, compliance in following prescribed medication treatment and medication side effects to include the following:

16.5.5.1 Laboratory studies for all medications which require laboratory monitoring as recommended in the most current Physician's Desk Reference.

16.5.5.1.1 Laboratory studies shall be reviewed and signed by a Qualified Psychiatric Practitioner or RN within two (2) days of receipt.

16.5.5.1.2 Results of laboratory studies shall be documented in the consumer's chart within thirty (30) days.

16.5.5.2 AIMS (Abnormal Involuntary Movement Scale) shall be performed no less than annually for consumers whose medication includes Tardive Dyskinesia as possible side effects of the medication.

16.5.5.3 Monitoring of vital signs at each visit with a Qualified Psychiatric Practitioner shall include:

16.5.5.3.1 Temperature;

16.5.5.3.2 Blood pressure;

16.5.5.3.3 Pulse; and

16.5.5.3.4 Respiration.

16.5.6 Screening and Assessment

16.5.6.1 Co-Occurring treatment programs will utilize a screening tool approved by DSAMH to screen all consumers for substance use disorders and mental health symptoms at intake, and annually thereafter.

16.5.6.2 Based on the screening results:

16.5.6.2.1 Assessment will be conducted using tools approved by DSAMH; AND

16.5.6.2.2 Clients will be placed in appropriate levels of care to meet their substance use and mental health needs.

16.5.7 Case Management

16.5.7.1 Based on the needs of the client, case management coordination shall include:

16.5.7.1.1 Coordination of medical services with the consumer's primary care physician when needed;

16.5.7.1.2 Linkage to medical services when a primary care physician has not been identified;

16.5.7.1.3 Coordination of crisis intervention and stabilization services as appropriate;

16.5.7.1.4 Assistance with achieving goals for independence as defined by the consumer;

16.5.7.1.5 Linkage to resources and opportunities through:

16.5.7.1.5.1 Support groups including but not limited to:

16.5.7.1.5.1.1 Sober support groups that meet the needs of co-occurring consumers;

16.5.7.1.5.1.2 Peer support/peer mentoring networks;

16.5.7.1.5.1.3 Social support networks;

16.5.7.1.5.1.4 Social skills training networks;

16.5.7.1.5.1.5 Family support networks; and

16.5.7.1.5.1.6 Other community services as needed.

16.5.7.1.6 Safe/decent/affordable housing when needed;

16.5.7.1.7 Entitlements;

16.5.7.1.8 Education and vocational services;

16.5.7.1.9 Transportation to and from the program; and

16.5.7.1.10 Other activities carried out in collaboration with the consumer.

16.5.7.2. When a Case Manager meeting the criteria of §16.2.6 of these standards is the sole provider of case management services, case loads shall not exceed a one to forty (1:40) staff: consumer ratio.

16.5.8 Psycho-Education and Counseling

16.5.8.1 Programs shall provide psycho-education for all consumers and family members on:

16.5.8.1.1 The efficacy of medications used for mental health diagnosis and the effects of substances on these medications; and

16.5.8.1.2 The treatment and maintenance of co-occurring disorders.

16.5.8.2 When appropriate, programs shall provide counseling that includes:

16.5.8.2.1 Group therapy that will support maintenance and stability of the consumer's psychiatric and substance use disorder;

16.5.8.2.2 Individual therapy to address all therapeutic issues that will support maintenance and stability of the consumer's psychiatric and substance use disorder; and

16.5.8.2.3 Family therapy to address therapeutic issues within the family that will support maintenance and stability of a consumer's psychiatric and substance use disorder.

16.5.8.3 Co-occurring treatment programs shall offer ample opportunity to consumers to attend community support groups that will enhance treatment for both mental health diagnosis and substance use disorders. Groups shall include but not be limited to:

16.5.8.3.1 In-house support groups provided by the co-occurring treatment program; and/or

16.5.8.3.2 Linkage to-12 step groups that support dual recovery for mental health diagnosis and substance use disorders (e.g. "Double Trouble"); and/or

16.5.8.3.3 Linkage to faith-based or other community networks including education programs, physical fitness programs, etc… that support dual recovery for mental health diagnosis and substance use disorders.

Part IV: Deemed Status

**History**
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
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- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *12 DE Reg. 464 (10/01/08)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*

##### **16 Del. Admin. Code § 6001-17.0** Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) {#sec-6001-17.0 omnilex-key=us-de-regs-official--title-16--6001-17.0}

17.1 Deemed Status Categories:

17.1.1 Programs with Full Accreditation may qualify for a 2 year license.

17.1.2 Programs that are accredited as part of a merger, consolidation or acquisition must submit verification that JCAHO will extend accreditation to the new entity.

17.2 Notification of Audit:

17.2.1 Programs must inform DSAMH of all JCAHO visits whether announced or unannounced. The Quality Assurance Unit shall be notified in writing of a scheduled visit no less than 30 days prior to the visit. The Quality Assurance Unit shall be notified by phone or email of an unannounced visit within twenty-four (24) hours of the first day of the visit.

17.3 Reporting to DSAMH

17.3.1 Programs must notify DSAMH of any immediate threat to life that is discovered by JCAHO during the visit within 24 hours of the day that the threat to life is discovered.

17.3.2 Programs must report all sentinel events to DSAMH within twenty-four (24) hours accompanied by the root cause analysis, action plan and action plan follow up activity reports prepared according to JCAHO guidelines.

17.3.3 Programs must submit to DSAMH any corrective action to address sentinel events at the same time they are submitted to JCAHO.

17.3.4 Programs must submit to DSAMH any other correspondence required by JCAHO during the course of the Accreditation period and/or between each JCAHO review.

17.4 Deemed Status Revocation

17.4.1 DSAMH can revocate Deemed Status standing at any time, but specifically when:

17.4.1.1 A program is unsuccessful in receiving Accreditation, or Provisional Accreditation from JCAHO;

17.4.1.2 In response to a sentinel event;

17.4.1.3 When reporting to DSAMH does not occur in according with the time table established above;

17.4.1.4 Following a survey by DSMAH when it is determined that the program is not operating under the JCAHO guidelines and/or DSAMH licensure standards.

17.4.2 Once revoked, a program must wait one (1) year before reapplying for Deemed Status. DSAMH must conduct a site review before restoring Deemed Status.

17.5 Program Exemptions:

17.5.1 Programs are exempt from the Division of Substance Abuse and Mental Health standards for Substance Abuse Treatment Programs with the exception of:

17.5.1.1 Standards Applicable to all Programs:

17.5.1.1.1 Section §5.0:

17.5.1.1.1.1 Subsection §5.1.2.1;

17.5.1.1.1.2 Subsection §5.1.4;

17.5.1.1.1.3 Subsection §5.1.7.1;

17.5.1.1.1.4 Subsection §5.1.7.2;

17.5.1.1.1.5 Subsection §5.1.7.3;

17.5.1.1.1.6 Subsection §5.1.8;

17.5.1.2 Section §6.0: Programs must be in compliance with all of section §6.0.

17.5.1.3 Section §8.0: Programs with Deemed Status are exempt from sub-section §8.1.2 of section §8.0. When client records are reviewed, DSAMH will accept documents in section §8.1.2. In the format accepted by JCAHO. Programs must be in compliance with all other subsections of section §8.0.

17.5.2 Section §9.0: Programs with Deemed Status are exempt from all standards in section §9.0. with the exception of §9.1.5. “smoke free facility”.

17.6 Standards Applicable to Specific Settings and Modalities

17.6.1 Programs must be in compliance with all standards specific to the modality for which the program is being licensed.

**History**
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *12 DE Reg. 464 (10/01/08)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*

##### **16 Del. Admin. Code § 6001-18.0** Commission on Accreditation of Rehabilitation Facilities (CARF) {#sec-6001-18.0 omnilex-key=us-de-regs-official--title-16--6001-18.0}

18.1 Deemed Status Categories

18.1.1 Programs with Three-Year Accreditation may qualify for a two (2) year license.

18.1.2 Programs that are accredited as part of a merger, consolidation or acquisition must submit verification that CARF will extend accreditation to the new entity.

18.2 Notification of Audit:

18.2.1 Programs must inform DSAMH of all CARF visits whether announced or unannounced. The Quality Assurance Unit should be notified in writing of a scheduled visit no less than 30 days prior to the visit. The Quality Assurance Unit should be notified by phone or email of an unannounced visit within 24 hours of the first day of the visit.

18.3 Reporting to DSAMH

18.3.1 Programs must notify DSAMH of any immediate threat to life that is discovered by CARF during the visit within twenty-four ( 24) hours of the day the threat to life is discovered.

18.3.2 Programs must report all other significant events to DSAMH within twenty-four (24) hours accompanied by the investigation report; action plan and action plan follow up activity reports prepared according to CARF guidelines.

18.3.3 Programs must submit to DSAMH any corrective action to address significant events at the same time they are submitted to CARF.

18.3.4 Programs must submit to DSAMH any other correspondence required by CARF during the course of the Accreditation period and/or between each CARF review.

18.4 Deemed Status Revocation

18.4.1 DSMAH can revocate Deemed Status standing at any time, but specifically when:

18.4.1.1 A program is unsuccessful in receiving Three-Year, or One-Year, Accreditation from CARF;

18.4.1.2 In response to a significant event;

18.4.1.3 When reporting to DSAMH does not occur in accordance with the time table established above;

18.4.1.4 Following a survey by DSMAH when it is determined that the program is not operating under the CARF guidelines and/or DSAMH licensure standards.

18.4.2 Once revoked, a program must wait 1 year before reapplying for Deemed Status. DSAMH must conduct a site review before restoring Deemed Status.

18.5 Program Exemptions:

18.5.1 Programs are exempt from the Division of Substance Abuse and Mental Health standards for Substance Abuse Treatment Programs with the exception of:

18.5.1.1 Standards Applicable to all Programs:

18.5.1.1.1 Section §5.0: Programs with Deemed status must be in compliance with the following subsections of section §5.0:

18.5.1.1.1.1 Subsection §5.1.3.1;

18.5.1.1.1.2 Subsections§ 5.1.6.3.5.3., §5.1.6.3.5.5.,§5.1.6.3.5.6., §5.1.6.3.5.7., §5.1.6.3.5.8., §5.1.6.3.5.9;

18.5.1.1.1.3 Subsection §5.1.6.4;

18.5.1.1.1.4 Subsection §5.1.6.5;

18.5.1.1.1.5 Subsection §5.1.7.4.

18.5.1.1.2 Section §6.0: Programs must be in compliance with all of section §6.0.

18.5.1.1.3 Section §8.0: Programs with Deemed Status are exempt from sub-section §8.1.2 of section §8.0. When client records are reviewed, DSAMH will accept documents in section §8.1.2 in the format accepted by CARF. Programs must be in compliance with all other subsections of section §8.0.

18.5.1.1.4 Section §9.0: Programs must be in compliance with standard §9.1.5: "smoke free facility".

18.5.1.2 Standards Applicable to Specific Settings and Modalities

18.5.1.2.1 Programs must be in compliance with all standards specific to the modality for which the program is being licensed.

**History**
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *12 DE Reg. 464 (10/01/08)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*

##### **16 Del. Admin. Code § 6001-19.0** Council on Accreditation (COA) {#sec-6001-19.0 omnilex-key=us-de-regs-official--title-16--6001-19.0}

19.1 Deemed Status Categories

19.1.1 Programs with Three-Year or Four-Year Accreditation may qualify for a 2 year license.

19.1.2 Programs that are accredited as part of a merger, consolidation or acquisition must submit verification that COA will extend accreditation to the new entity.

19.2 Notification of Audit:

19.2.1 Programs must inform DSAMH of all COA visits whether announced or unannounced. The Quality Assurance Unit should be notified in writing of a scheduled visit no less than 30 days prior to the visit. The Quality Assurance Unit should be notified by phone or email of an unannounced visit within 24 hours of the first day of the visit.

19.3 Reporting to DSAMH

19.3.1 Programs must notify DSAMH of any immediate threat to life that is discovered by COA during the visit within 24 hours of the day the threat to life is discovered.

19.3.2 Programs must report all other hazardous or emergency situations to DSAMH within 24 hours accompanied by the investigation report; action plan and action plan follow up activity reports prepared according to COA guidelines.

19.3.3 Programs must submit to DSAMH any corrective action to address hazardous or emergency situations at the same time they are submitted to COA.

19.3.4 Programs must submit to DSAMH any other correspondence required by COA during the course of the Accreditation period and/or between each COA review.

19.4 Deemed Status Revocation

19.4.1 DSMAH can revocate Deemed Status standing at any time, but specifically when:

19.4.1.1 A program is unsuccessful in receiving Three-Year or Four-Year Accreditation from COA;

19.4.1.2 In response to a hazardous or emergency event;

19.4.1.3 When reporting to DSAMH does not occur in accordance with the time table established above;

19.4.1.4 Following a survey by DSMAH when it is determined that the program is not operating under the COA guidelines and/or DSAMH licensure standards.

19.4.2 Once revoked, a program must wait 1 year before reapplying for Deemed Status. DSAMH must conduct a full site review before restoring Deemed Status.

19.5 Program Exemptions:

19.5.1 Programs are exempt from the Division of Substance Abuse and Mental Health standards for Substance Abuse Treatment Programs with the exception of:

19.5.1.1 Standards Applicable to all Programs:

19.5.1.1.1 Section §5.0: Programs with Deemed status must be in compliance with the following subsections of section 5.0:

19.5.1.1.1.1 Subsection §5.1.3.1;

19.5.1.1.1.2 Subsections §5.1.6.3.5.3, §5.1.6.3.5.5, §5.1.6.3.5.6, §5.1.6.3.5.7, §5.1.6.3.5.8, §5.1.6.3.5.9;

19.5.1.1.1.3 Subsection §5.1.6.4;

19.5.1.1.1.4 Subsection §5.1.6.5;

19.5.1.1.1.5 Subsection §5.1.7.4.

19.5.1.1.2 Section §6.0: Programs must be in compliance with all of section §6.0.

19.5.1.1.3 Section §8.0: Programs with Deemed Status are exempt from sub-section 8.1.2.1.1 of section 8.0. When client records are reviewed, DSAMH will accept documents in section 8.1.2 in the format accepted by COA. Programs must be in compliance with all other subsections of section §8.0.

19.5.1.1.4 Section §9.0: Programs must be in compliance with standard §9.1.5: "smoke free facility".

19.5.1.2 Standards Applicable to Specific Settings and Modalities

19.5.1.2.1 Programs must be in compliance with all standards specific to the modality for which the program is being licensed.

**History**
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *12 DE Reg. 464 (10/01/08)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*
- *14 DE Reg. 471 (11/01/10)*

#### **6002** Credentialed Mental Health Screeners

##### **16 Del. Admin. Code § 6002-1.0** Authority {#sec-6002-1.0 omnilex-key=us-de-regs-official--title-16--6002-1.0}

The Division of Substance Abuse and Mental Health, within the Department of Health and Social Services, promulgates this regulation under the authority of 16 Del.C. §5004.

**History**
- *16 DE Reg. 992 (03/01/13)*
- *17 DE Reg. 72 (07/01/13)*
- *27 DE Reg. 185 (09/01/23)*

##### **16 Del. Admin. Code § 6002-2.0** Definitions {#sec-6002-2.0 omnilex-key=us-de-regs-official--title-16--6002-2.0}

The following words and terms, when used in this regulation, have the following meaning:

"Advanced Practice Registered Nurse" or "APRN" means as defined under 24 Del.C. §1902(b).

"Baccalaureate Social Worker" or "BSW" means as defined under 24 Del.C. §3902(5).

"Certificate to practice medicine" or "medical license" means as defined under 24 Del.C. §1702(2).

"Credentialed mental health screener" or "screener" means as defined under 16 Del.C. §5001(2).

"Designated psychiatric treatment facilities" or "facility" means as defined under 16 Del.C. §5001(6).

"Division" means the Division of Substance Abuse and Mental Health.

"Institutional License" or "training license" means a medical license as outlined under 24 Del.C. §1722(a)(2).

"Licensed clinical social worker" or "LCSW" means as defined under 24 Del.C. §3902(18).

"Licensed marriage and family therapist" or "LMFT" means as defined under 24 Del.C. §3051(c).

"Licensed mental health professional" or "LMHP" means any of the following:

"Licensed professional counselor of mental health" or "LPCMH" means as defined under 24 Del.C. §3031(2).

"Physician" means as defined under 24 Del.C. §1702(10). The term includes an allopathic Doctor of Medicine and surgery or a Doctor of Osteopathic Medicine and Surgery with a valid license to practice medicine working in a United States Department of Veterans Affairs medical center in the State.

"Physicians Assistant" or "PA-C" means as defined under 24 Del.C. §1770A(4).

"Psychiatric-mental health advanced practice registered nurse" or "PMH-APRN" means an APRN certified as a psychiatric-mental health nurse practitioner by the American Nurses Credentialing Center.

"Psychiatrist" means as defined under 16 Del.C. §5001(15).

"Psychiatry resident" means an individual who holds a training license and is enrolled in an accredited residency training program in psychiatry.

"Psychologist" means as defined under 24 Del.C. §3502(7).

"Relative" means an individual related to another by consanguinity or affinity within the third degree.

"Screening" means the emergency assessment of an individual's mental condition to determine the need for involuntary observation or treatment or both by a screener under 16 Del.C. Ch. 50.

"Unlicensed mental health professional" or "UMHP" means an individual who is not a psychiatrist, physician, PMH-APRN, or LMHP.

"Victim" means as defined under 11 Del.C. §9401(7).

**History**
- *16 DE Reg. 992 (03/01/13)*
- *17 DE Reg. 72 (07/01/13)*
- *27 DE Reg. 185 (09/01/23)*

##### **16 Del. Admin. Code § 6002-3.0** Purpose {#sec-6002-3.0 omnilex-key=us-de-regs-official--title-16--6002-3.0}

This regulation sets forth the requirements and procedures for conducting screenings, registering psychiatrists, and credentialing screeners.

**History**
- *16 DE Reg. 992 (03/01/13)*
- *17 DE Reg. 72 (07/01/13)*
- *27 DE Reg. 185 (09/01/23)*

##### **16 Del. Admin. Code § 6002-4.0** Applicability {#sec-6002-4.0 omnilex-key=us-de-regs-official--title-16--6002-4.0}

This regulation applies to all screeners.

**History**
- *16 DE Reg. 992 (03/01/13)*
- *17 DE Reg. 72 (07/01/13)*
- *27 DE Reg. 185 (09/01/23)*

##### **16 Del. Admin. Code § 6002-5.0** Screening Prerequisites {#sec-6002-5.0 omnilex-key=us-de-regs-official--title-16--6002-5.0}

5.1 Except as otherwise provided under subsections 5.2 and 5.3 of this regulation, an individual must not conduct a screening.

5.2 A psychiatrist registered by the Division may conduct a screening.

5.3 An individual credentialed by the Division may conduct a screening.

**History**
- *16 DE Reg. 992 (03/01/13)*
- *17 DE Reg. 72 (07/01/13)*
- *27 DE Reg. 185 (09/01/23)*

##### **16 Del. Admin. Code § 6002-6.0** Qualifications {#sec-6002-6.0 omnilex-key=us-de-regs-official--title-16--6002-6.0}

6.1 Before registering with the Division to perform screenings, a psychiatrist must do all of the following:

6.1.1 Possess a valid medical license.

6.1.2 Complete an accredited residency training program in psychiatry.

6.2 Before applying for credentialing, a physician must possess a valid medical license.

6.3 Before applying for credentialing, a PMH-APRN must possess a valid license and a valid psychiatric-mental health nurse practitioner certification from the American Nurses Credentialing Center.

6.4 Before applying for credentialing, an LMHP must do all of the following:

6.4.1 Possess at least 1 of the following:

6.4.1.1 Valid licensure as an LCSW.

6.4.1.2 Valid licensure as an LPCMH.

6.4.1.3 Valid licensure as a PA-C and valid certification in psychiatry by the National Commission on Certification of Physician Assistants.

6.4.1.4 Valid licensure as a psychologist.

6.4.1.5 A valid training license and proof of enrollment in an accredited residency training program in psychiatry.

6.4.2 Have at least 2 years of direct experience providing clinical services to individuals with mental health conditions.

6.5 Before applying for credentialing from the Division, a UMHP must practice under the supervision of a psychiatrist and do at least 1 of the following:

6.5.1 Have a bachelor's degree in a mental health-related field from an accredited educational institution and at least 4 years of direct experience providing clinical services to individuals with mental health conditions.

6.5.2 Have at least a master's degree in a mental health-related field from an accredited educational institution and at least 2 years of direct experience providing clinical services to individuals with mental health conditions.

**History**
- *16 DE Reg. 992 (03/01/13)*
- *17 DE Reg. 72 (07/01/13)*
- *27 DE Reg. 185 (09/01/23)*

##### **16 Del. Admin. Code § 6002-7.0** Registration of Psychiatrists {#sec-6002-7.0 omnilex-key=us-de-regs-official--title-16--6002-7.0}

7.1 Except as otherwise provided under this subsection, the Division may not register a psychiatrist. The Division shall register a psychiatrist that does all of the following:

7.1.1 Meets the qualifications under Section 6.0 of this regulation.

7.1.2 Applies to the Division by completing the Division's application form and submitting documentation proving that the psychiatrist is qualified under Section 6.0 of this regulation.

7.2 Except as otherwise provided under subsections 7.3, 7.4, and 7.5 of this regulation, a psychiatrist's registration is valid for 10 years from the date the Division registers the psychiatrist.

7.3 If a psychiatrist applies to renew their registration before it expires, their registration is valid until the Division approves or rejects the application.

7.4 Whenever a psychiatrist does not comply with federal, state, or local law, regulation, or policy, the Division may deregister the psychiatrist.

7.5 Whenever a psychiatrist registered with the Division does not meet the requirements under Section 6.0 of this regulation, the Division shall deregister the psychiatrist.

7.6 The Division shall notify a psychiatrist immediately after deregistering the psychiatrist.

7.7 A psychiatrist may appeal deregistration to the Division Director. An appeal must be made in writing no later than 10 days after the Division deregisters the psychiatrist under subsection 7.4 or 7.5 of this regulation. No more than 30 days after receiving the appeal, the Division Director shall review the appeal, make a final determination, and notify the psychiatrist of the determination.

**History**
- *16 DE Reg. 992 (03/01/13)*
- *17 DE Reg. 72 (07/01/13)*
- *27 DE Reg. 185 (09/01/23)*

##### **16 Del. Admin. Code § 6002-8.0** Credentialing {#sec-6002-8.0 omnilex-key=us-de-regs-official--title-16--6002-8.0}

8.1 Except as otherwise provided under this subsection, the Division may not credential an individual. The Division shall credential an individual that does all of the following:

8.1.1 Meets the qualifications under Section 6.0 of this regulation.

8.1.2 Applies to the Division by completing the Division's application form and submitting documentation proving that the individual is qualified under Section 6.0 of this regulation.

8.1.3 Completes the Division-required training.

8.1.4 Achieves a satisfactory score on the Division's examination.

8.2 Except as otherwise provided under subsections 8.3, 8.4, and 8.5 of this regulation, a credential is valid for 2 years from the date of issuance by the Division.

8.3 If a screener applies to renew their credential before it expires, the credential is valid until the Division approves or rejects the application.

8.4 The Division may suspend or revoke a screener's credential whenever the individual fails to comply with federal, state, or local law, regulation, or policy.

8.5 Whenever a screener does not meet the requirements under Section 6.0 of this regulation, the Division shall revoke the screener's credential.

8.6 The Division shall notify a screener immediately after suspending or revoking the screener's credential.

8.7 A screener may appeal a revocation or suspension of their credential to the Division Director. An appeal must be made in writing no later than 10 days after the Division suspends or revokes the screener's credential under subsection 8.4 or 8.5 of this regulation. No more than 30 days after receiving the appeal, the Division Director shall review the appeal, make a final determination, and notify the screener of the determination.

**History**
- *16 DE Reg. 992 (03/01/13)*
- *17 DE Reg. 72 (07/01/13)*
- *27 DE Reg. 185 (09/01/23)*

##### **16 Del. Admin. Code § 6002-9.0** Screenings {#sec-6002-9.0 omnilex-key=us-de-regs-official--title-16--6002-9.0}

A screener must conduct a screening per 16 Del.C. Ch. 50, this regulation, and the Division's policies.

**History**
- *16 DE Reg. 992 (03/01/13)*
- *17 DE Reg. 72 (07/01/13)*
- *27 DE Reg. 185 (09/01/23)*

##### **16 Del. Admin. Code § 6002-10.0** Conflicts of Interest {#sec-6002-10.0 omnilex-key=us-de-regs-official--title-16--6002-10.0}

10.1 Whenever a screener conducts a screening, the screener shall disclose any existing or potential conflict of interest relating to the individual undergoing screening.

10.2 Conflicts of interest include the following:

10.2.1 The screener is a relative of the individual undergoing screening.

10.2.2 The screener is an employee of a facility.

10.2.3 The screener is a victim or the relative of a victim of a crime committed by the individual undergoing screening.

10.3 A disclosure under this section must be made in writing on the form provided by the Division.

**History**
- *16 DE Reg. 992 (03/01/13)*
- *17 DE Reg. 72 (07/01/13)*
- *27 DE Reg. 185 (09/01/23)*

#### **6003** DUI Programs

##### **16 Del. Admin. Code § 6003-1.0** Authority {#sec-6003-1.0 omnilex-key=us-de-regs-official--title-16--6003-1.0}

The Division of Substance Abuse and Mental Health within the Department of Health and Social Services promulgates this regulation under the authority of 21 Del.C. §4177D.

**History**
- *25 DE Reg. 1021 (05/01/22)*
- *25 DE Reg. 1021 (05/01/22)*
- *25 DE Reg. 783 (02/01/22)*
- *25 DE Reg. 1021 (05/01/22)*

##### **16 Del. Admin. Code § 6003-2.0** Definitions {#sec-6003-2.0 omnilex-key=us-de-regs-official--title-16--6003-2.0}

The following words and terms, when used in this regulation, have the following meaning unless the context clearly indicates otherwise:

"Activity" means a program's appointment, class, meeting, or session with at least one participant.

"Blood alcohol concentration" or "BAC" means the grams of alcohol per 100 milliliters of blood or 210 liters of breath in a sample taken from a participant during a chemical test.

"Chemical test" means as defined under 21 Del.C. §4177.

"Defamatory language" means language that is defamatory towards a person or group based on age, creed, disability, familial status, ethnicity, gender, gender identity, national origin, sexual orientation, race, religion, or other protected classification.

"Division" means the Division of Substance Abuse and Mental Health.

"Driving under the influence" or "DUI" means a violation subject to punishment under 21 Del.C. §§4177, 4177B, 4177L, 4177M, or 23 Del.C. §§2305(2), 2305(3), or 2305(4).

"Drugs" means as defined under 21 Del.C. §4177.

"Governing body" means an individual, board, or other entity with ultimate responsibility for the management, operation, and control of a program.

"Instructor" means an employee of a program presenting educational classes to participants.

"License" means a license granted by the Division to provide substance use disorder treatment.

"Nonresident" means an individual that is not a resident of the State of Delaware.

"Participant" means an individual, 18 years or older, subject to 21 Del.C. §4177D or 23 Del.C. §2305(8).

"Program" means an entity providing services.

"Resident" means an individual living or attending school in Delaware or living within one hour’s travel time of Delaware.

"Services" means screening and referral, educational, or treatment services.

**History**
- *25 DE Reg. 1021 (05/01/22)*
- *25 DE Reg. 1021 (05/01/22)*
- *25 DE Reg. 783 (02/01/22)*
- *25 DE Reg. 1021 (05/01/22)*

##### **16 Del. Admin. Code § 6003-3.0** Purpose {#sec-6003-3.0 omnilex-key=us-de-regs-official--title-16--6003-3.0}

This regulation adopts rules and fees for programs providing services to participants.

**History**
- *25 DE Reg. 1021 (05/01/22)*
- *25 DE Reg. 1021 (05/01/22)*
- *25 DE Reg. 783 (02/01/22)*
- *25 DE Reg. 1021 (05/01/22)*

##### **16 Del. Admin. Code § 6003-4.0** Applicability {#sec-6003-4.0 omnilex-key=us-de-regs-official--title-16--6003-4.0}

4.1 Except as otherwise provided under subsection 4.2 of this regulation, this regulation applies to programs and participants.

4.2 This regulation does not apply to the Court of Common Pleas Driving Under the Influence Treatment Program or the Program's participants.

**History**
- *25 DE Reg. 1021 (05/01/22)*
- *25 DE Reg. 1021 (05/01/22)*
- *25 DE Reg. 783 (02/01/22)*
- *25 DE Reg. 1021 (05/01/22)*

##### **16 Del. Admin. Code § 6003-5.0** Programs {#sec-6003-5.0 omnilex-key=us-de-regs-official--title-16--6003-5.0}

5.1 A program may provide services if the program is authorized, contracted, and licensed by the Division to provide substance use disorder services.

5.2 The Division may authorize and contract with a program to provide one or more of the following service types:

5.2.1 Screening and referral.

5.2.2 Education.

5.2.3 Treatment.

5.3 A program must comply with the requirements of the program's license and other requirements issued by the Division.

5.4 A program's governing body must designate a program director responsible for the program's daily operation and administration.

5.5 A program must have written rules and policies for at least the following:

5.5.1 Protection of participant rights including informed consent.

5.5.2 Submission of grievances and appeals of program decisions.

5.5.3 Confidentiality of participant records.

5.5.4 Participant conduct.

5.5.5 Attendance, including requesting and excusing absences.

5.5.6 Leaves of absence.

5.5.7 Rescheduling activities.

5.5.8 Payments to the program.

5.6 A program must maintain a record for each participant.

**History**
- *25 DE Reg. 1021 (05/01/22)*
- *25 DE Reg. 1021 (05/01/22)*
- *25 DE Reg. 783 (02/01/22)*
- *25 DE Reg. 1021 (05/01/22)*

##### **16 Del. Admin. Code § 6003-6.0** Participant Conduct {#sec-6003-6.0 omnilex-key=us-de-regs-official--title-16--6003-6.0}

6.1 A participant must comply with rules and policies adopted by a program and the requirements of this regulation.

6.2 Whenever participating in a program, a participant must do all of the following:

6.2.1 Be respectful of staff and other participants.

6.2.2 Attend scheduled program activities.

6.2.3 Pass required urine drug screenings.

6.2.4 Actively participate during program activities.

6.2.5 Dress and groom in a manner that falls within generally accepted definitions of neatness and cleanliness.

6.3 A participant must not do any of the following:

6.3.1 Engage in aggressive, hostile, harassing, threatening, or violent behavior.

6.3.2 Act in a manner that endangers the health and safety of staff or other participants.

6.3.3 Be disruptive or distracting.

6.3.4 Communicate using profanity or defamatory language.

6.3.5 Commit a criminal or traffic offense.

6.3.6 Except for prescribed medication taken according to a prescription, use or consume alcohol or drugs.

**History**
- *25 DE Reg. 1021 (05/01/22)*
- *25 DE Reg. 1021 (05/01/22)*
- *25 DE Reg. 783 (02/01/22)*
- *25 DE Reg. 1021 (05/01/22)*

##### **16 Del. Admin. Code § 6003-7.0** Attendance {#sec-6003-7.0 omnilex-key=us-de-regs-official--title-16--6003-7.0}

7.1 Whenever a program schedules a participant to attend an activity, the program must provide the participant with notice at least five days before the activity. The notice must include the activity's start time and location. A program providing a participant with a schedule of all the participant's scheduled activities fulfills the requirements under this subsection.

7.2 To successfully attend an activity, a participant must do all of the following:

7.2.1 Arrive before the activity starts.

7.2.2 Sign in on the form provided.

7.2.3 Be present for the entirety of the activity.

7.2.4 Actively participate.

7.3 Except if excused, a participant is absent from an activity whenever the participant does not attend an activity.

7.4 A participant's absence is excused from an activity whenever any of the following occurs:

7.4.1 The participant notifies a program during regular business hours at least 24 hours before the start of an activity and requests to be excused.

7.4.2 The participant's absence is due to events that are wholly beyond the participant's control, or the participant otherwise demonstrates good cause.

7.4.3 The activity does not begin less than one hour after the scheduled start time.

7.4.4 The program cancels the activity.

7.5 A participant may request that a program excuse an absence. The program may request reasonable documentation to support the participant's request.

7.6 If a participant is absent or excused, the participant must make up the missed activity no more than seven days after the initially scheduled date. If the participant fails to make up the missed activity, the absence counts towards the participant's limit.

7.7 A participant is allowed one absence from a screening and referral activity and two absences from an educational or treatment activity.

7.8 Except if a program grants a participant a leave of absence, the program may dismiss the participant from the program whenever a participant does not attend an activity for 21 consecutive days.

7.9 A participant may request a leave of absence from a program. Subject to the approval of the program's director, a program may grant the participant's request if the participant does all of the following:

7.9.1 Requests the leave in advance.

7.9.2 Demonstrates good cause.

7.9.3 Provides reasonable documentation to support the request.

**History**
- *25 DE Reg. 1021 (05/01/22)*
- *25 DE Reg. 1021 (05/01/22)*
- *25 DE Reg. 783 (02/01/22)*
- *25 DE Reg. 1021 (05/01/22)*

##### **16 Del. Admin. Code § 6003-8.0** Screenings {#sec-6003-8.0 omnilex-key=us-de-regs-official--title-16--6003-8.0}

8.1 As used in this section, "program" means a program providing screening and referral services.

8.2 Except if a program screens a participant, a program must not refer a participant to an educational course or treatment services.

8.3 A participant must contact a program to schedule a screening appointment. During the appointment, the program must screen the participant using a Division-approved standardized tool. After screening the participant, the program must complete a screening report for the participant in the manner authorized by the Division.

8.4 Subject to Section 9.0 of this regulation, a program must refer a participant for appropriate services after completing a screening report.

8.5 A program may screen a participant remotely.

**History**
- *25 DE Reg. 1021 (05/01/22)*
- *25 DE Reg. 1021 (05/01/22)*
- *25 DE Reg. 783 (02/01/22)*
- *25 DE Reg. 1021 (05/01/22)*

##### **16 Del. Admin. Code § 6003-9.0** Referrals {#sec-6003-9.0 omnilex-key=us-de-regs-official--title-16--6003-9.0}

9.1 A program must refer a participant younger than 18 years to a treatment program approved by the Department of Services for Children, Youth, and Their Families.

9.2 A program must refer a participant to a program for educational services whenever all of the following conditions exist:

9.2.1 The participant's DUI is the participant's first.

9.2.2 The participant's BAC was less than .15.

9.2.3 The participant's screening report identifies a low risk of substance use disorder.

9.3 A program must refer a participant to a program for treatment services whenever any of the following conditions exist:

9.3.1 The participant's DUI is the participant's first and any of the following conditions exist:

9.3.1.1 The participant's screening report identifies a moderate or higher risk of substance use disorder.

9.3.1.2 The participant's BAC was .15 or more.

9.3.1.3 The participant refused to submit to a chemical test.

9.3.1.4 The participant's DUI involved the use of drugs.

9.3.2 The participant's DUI is the participant's second within 10 years and the participant's BAC was .15 or less.

9.4 A program must refer a participant to a program for intensive treatment services whenever any of the following conditions exist:

9.4.1 The participant's DUI is the participant's second within 10 years and any of the following conditions exist:

9.4.1.1 The participant's BAC was .15 or more.

9.4.1.2 The participant refused to submit to a chemical test.

9.4.1.3 The participant's DUI involved the use of drugs.

9.4.2 The participant's DUI is the participant's third or subsequent DUI.

9.5 Whenever a participant does not meet the criteria under subsections 9.2 through 9.4 of this regulation, a program must refer the participant for appropriate treatment services based on the participant's risk of substance use disorder identified in the participant's screening report.

9.6 Whenever a participant's screening report indicates co-occurring mental health or medical conditions, a program must provide the participant with a referral to appropriate services.

**History**
- *25 DE Reg. 1021 (05/01/22)*
- *25 DE Reg. 1021 (05/01/22)*
- *25 DE Reg. 783 (02/01/22)*
- *25 DE Reg. 1021 (05/01/22)*

##### **16 Del. Admin. Code § 6003-10.0** Educational Services {#sec-6003-10.0 omnilex-key=us-de-regs-official--title-16--6003-10.0}

10.1 As used in this section, "program" means a program providing educational services.

10.2 A program must adopt a curriculum approved by the Division.

10.3 A program must present an educational course that consists of 16 hours of instruction.

10.4 An instructor presenting a class must have all of the following:

10.4.1 Necessary training or certification on the curriculum.

10.4.2 Relevant knowledge of the criminal justice system.

10.4.3 Training or experience as an instructor.

10.5 A program's director shall review and approve each instructor's qualifications.

**History**
- *25 DE Reg. 1021 (05/01/22)*
- *25 DE Reg. 1021 (05/01/22)*
- *25 DE Reg. 783 (02/01/22)*
- *25 DE Reg. 1021 (05/01/22)*

##### **16 Del. Admin. Code § 6003-11.0** Treatment Services {#sec-6003-11.0 omnilex-key=us-de-regs-official--title-16--6003-11.0}

11.1 As used in this section, "program" means a program providing treatment services.

11.2 A program must provide treatment services per the program's license.

11.3 Before providing treatment services to a participant, a program must assess the participant using standardized, evidence-based instruments approved by the Division.

11.4 After a participant's assessment, a program must create a written, individualized, and outcome-oriented treatment plan for the participant. The plan must do at least the following:

11.4.1 Identify and respond to the evidence and determinations arising from the participant's assessment.

11.4.2 State the specific interventions recommended by the program and the evidence supporting the interventions.

11.4.3 State the requirements and expectations for the participant's satisfactory completion of treatment.

11.4.4 State the consequences for the participant for failing to complete treatment.

11.5 A program must treat a participant according to the participant's treatment plan.

11.6 A program may require a participant to submit to urine drug screenings as part of the participant's treatment plan. Subject to the Division's approval, a program administering urine drug screenings must adopt written policies and procedures for conducting the screenings.

**History**
- *25 DE Reg. 1021 (05/01/22)*
- *25 DE Reg. 1021 (05/01/22)*
- *25 DE Reg. 783 (02/01/22)*
- *25 DE Reg. 1021 (05/01/22)*

##### **16 Del. Admin. Code § 6003-12.0** Completion Requirements {#sec-6003-12.0 omnilex-key=us-de-regs-official--title-16--6003-12.0}

12.1 A program may grant a certificate of completion to a participant receiving education services whenever the participant does all of the following:

12.1.1 Attends 16 hours of educational activities.

12.1.2 Attends a meeting of a mutual-help group.

12.1.3 Has a DUI avoidance plan approved by an instructor.

12.1.4 Pays the required fees.

12.2 A program may grant a certificate of completion to a participant receiving treatment services whenever the participant satisfies the requirements of their treatment plan, attends 16 hours of treatment activities, and pays the fees required by the program.

12.3 A program may grant a certificate of completion to a participant receiving intensive treatment services whenever the participant satisfies the requirements of their treatment plan, attends 27 hours of treatment activities, and pays the fees required by the program.

12.4 A program may grant a certificate of completion to a nonresident participant if the participant substantially satisfies the requirements of this section in their home state. Subject to the Division's approval, the program must establish policies and procedures to assist a nonresident participant satisfactorily in complying with the requirements of this section.

**History**
- *25 DE Reg. 1021 (05/01/22)*
- *25 DE Reg. 1021 (05/01/22)*
- *25 DE Reg. 783 (02/01/22)*
- *25 DE Reg. 1021 (05/01/22)*

##### **16 Del. Admin. Code § 6003-13.0** Fees and Payments {#sec-6003-13.0 omnilex-key=us-de-regs-official--title-16--6003-13.0}

13.1 Except as authorized under this section, a program may not charge a participant a fee.

13.2 A program may charge a participant any of the following administrative fees:

13.2.1 $50 or less per absence.

13.2.2 $30 or less for a late payment.

13.3 An education or treatment program may charge a participant any of the following administrative fees:

13.3.1 $150 or less for supervision and processing of a nonresident.

13.3.2 $50 or less for processing the participant's transfer to another program.

13.3.3 $50 or less for reinstating the participant after the participant's dismissal.

13.3.4 $50 or less for materials.

13.4 A program may charge a participant any of the following service fees:

13.4.1 $150 or less for screening and referral services.

13.4.2 $35 or less per urine drug screen.

13.5 An education program may charge a participant a total program fee of $400 or less for 16-hours of education activities.

13.6 A treatment program may charge a participant a total program fee of $1,000 or less for 16-hours of treatment activities.

13.7 A treatment program may charge a participant a total program fee of $1,700 or less for 27-hours of intensive treatment activities.

13.8 If a program excuses a participant's absence, the program may not charge the participant a fee under subsections 13.2.1 or 13.2.2 of this regulation.

13.9 A program fee charged by a program under subsections 13.6 or 13.7 of this regulation is subject to the Department and Division's policies and the program's contractual agreements with the State.

13.10 A participant is responsible for paying fees charged by a program.

13.11 A program must provide participants with a receipt at the time of payment and maintain a record of payments made by participants. A program must provide a copy of the record to the Division upon request.

13.12 A program must accept participant payments made via cash, cashier's check, certified check, money order, or a third-party payer. A program may accept participant payments made via credit card, debit card, or personal check.

13.13 A program may require payment before providing services.

13.14 A program may establish payment agreements with participants.

**History**
- *25 DE Reg. 1021 (05/01/22)*
- *25 DE Reg. 1021 (05/01/22)*
- *25 DE Reg. 783 (02/01/22)*
- *25 DE Reg. 1021 (05/01/22)*

##### **16 Del. Admin. Code § 6003-14.0** Disciplinary Actions {#sec-6003-14.0 omnilex-key=us-de-regs-official--title-16--6003-14.0}

14.1 A participant commits a violation whenever the participant does not comply with the requirements of Section 6.0 of this regulation or exceeds the allowed number of absences under subsection 7.7 of this regulation. Each absence beyond the permitted number of absences counts as a new violation. A program may determine that a participant has committed multiple violations as part of one incident.

14.2 Whenever a participant commits a violation, a program may impose sanctions on the participant.

14.3 A participant is subject to disqualification from receiving services under this regulation whenever the participant does any of the following:

14.3.1 Commits three or more violations.

14.3.2 Commits a criminal or traffic offense.

14.3.3 Threatens or engages in violence.

14.3.4 Acts in a manner that the program believes requires the participant's disqualification.

14.4 A program must maintain a record of a participant's violations.

14.5 Whenever a program determines that a participant commits a violation, the program must inform the participant in writing. A violation constitutes an adverse action.

14.6 If a program disqualifies a participant, the program must notify the participant, the Division, and the court.

14.7 Whenever a program disqualifies a participant, the participant may not participate in activities under this regulation.

14.8 A participant may appeal a violation or disqualification under Section 15.0 of this regulation.

**History**
- *25 DE Reg. 1021 (05/01/22)*
- *25 DE Reg. 1021 (05/01/22)*
- *25 DE Reg. 783 (02/01/22)*
- *25 DE Reg. 1021 (05/01/22)*

##### **16 Del. Admin. Code § 6003-15.0** Appeals {#sec-6003-15.0 omnilex-key=us-de-regs-official--title-16--6003-15.0}

15.1 Whenever a program takes adverse action against a participant, the participant may appeal the adverse action to the program's director by submitting a written request on the form approved by the Division no more than 10 days after receiving written notice of the adverse action from the program.

15.2 Except if submitted according to subsection 15.1 of this regulation, a program must not consider an appeal.

15.3 A program director must review an appeal no more than five days after receiving the appeal. The program director's review must be based on the form submitted under subsection 15.1 of this regulation and contemporaneous documentation and records. A program is not required to conduct a hearing.

15.4 No more than 10 days after receiving an appeal, and after conducting a review under subsection 15.3 of this regulation, a program director must issue a written decision that contains at least the following:

15.4.1 A concise statement of the adverse action.

15.4.2 A concise statement of the appeal.

15.4.3 If applicable, a summary of the evidence.

15.4.4 The decision of the program director to take one of the following actions:

15.4.4.1 Dismiss the appeal.

15.4.4.2 Grant the appeal.

15.4.4.3 Partially grant the appeal and modify the adverse action.

15.5 Notice of a decision issued under subsection 15.4 of this regulation must be given to a participant. The notice must include a copy of the written decision. A program must maintain a copy of a decision.

15.6 If a program director does not issue a decision within the time provided under subsection 15.4 of this regulation, the appeal is automatically granted and the adverse action is void.

15.7 A participant may appeal a program director's decision by submitting a written request on the form approved by the Division no more than 10 days after receiving notice of the decision under subsection 15.5 of this regulation.

15.8 Except if submitted according to subsection 15.7 of this regulation, the Division must not consider an appeal.

15.9 The Division Director shall appoint a review committee consisting of three Division staff to consider appeals made under subsection 15.7 of this regulation. The committee must meet at least monthly.

15.10 The committee's members must review the available record. The Division is not required to conduct a hearing. At the meeting, the committee must, by majority vote, make one of the following determinations:

15.10.1 To dismiss the appeal.

15.10.2 To grant the appeal.

15.10.3 To partially grant the appeal and modify the adverse action.

15.11 The Division must notify the participant and the program in writing of the review committee's determination under subsection 15.10 of this regulation.

15.12 The determination of the review committee is final.

**History**
- *25 DE Reg. 1021 (05/01/22)*
- *25 DE Reg. 1021 (05/01/22)*
- *25 DE Reg. 783 (02/01/22)*
- *25 DE Reg. 1021 (05/01/22)*

### **8000** Division of Services for Aging and Adults with Physical Disabilities

#### **8101** Delegation of Power of Relative Caregivers to Consent for Registering Minors for School

##### **16 Del. Admin. Code § 8101-1.0** Definitions for terms used in 14 DelC. §202: {#sec-8101-1.0 omnilex-key=us-de-regs-official--title-16--8101-1.0}

1.1 Establishment of Delegation of Power of Relative Caregivers to Consent for Registering Minors for School (also known as Caregivers’ School Authorization) (found in subsection (e)(2)(c) of section 202) – An affidavit of written or printed declaration or statement of facts, made voluntarily, and confirmed by the oath or affirmation of the party making it, and taken by a licensed notary.

**History**
- *4 DE Reg. 1016 (12/1/00)*

##### **16 Del. Admin. Code § 8101-2.0** Proof of relationship and Proof of caregiving: (found in subsection (f)(1) ) {#sec-8101-2.0 omnilex-key=us-de-regs-official--title-16--8101-2.0}

2.1 There must be two different forms of documentation, one from each column. One must show proof of relationship and the other proof of caregiving. These documents, or other similar documents as approved by the school district, must be presented for registration.

PROOF OF RELATIONSHIP

PROOF OF CAREGIVING

Birth certificate of caregiver, the parent, and birth certificate of the child.

Medical records where a caregiver is required to give approval, such as shots. Such records must show the relationship between the caregiver and the child.

Medical records where a caregiver’s authorization to give approval for services such as shots was acceptable.

A Will which lists the child and the relationship between the caregiver and child.

PROOF OF RELATIONSHIP

PROOF OF CAREGIVING

Insurance for the caregiver or child which includes the relationship between the caregiver and child.

A letter from a social worker, lawyer, religious leader, previous school district, licensed medical, mental health or behavioral professionals which verifies the relationship of the child to the caregiver.

A letter from a social worker, lawyer, religious leaders, licensed medical, mental health or behavioral professionals or neighbor confirming the child is being cared for by the caregiver.

Free and Reduced lunch program application.

Child is listed as occupant in an apartment or other housing and his/her relationship to the caregiver is included.

Child is listed as occupant in an apartment or other housing and his/her relationship to the caregiver is given.

Caregiver receives Child-only Temporary Aid for Needy Families (TANF) grant for this child.

Caregiver received Child-only Temporary Aid for Needy Families (TANF) grant for this child.

Child claimed on Federal Income Tax return.

Child claimed on Federal Income Tax return.

Caregiver receives Earned Income Tax Credit for the child.

Caregiver receives Earned Income Tax Credit for the child.

Child’s Social Security survivor death benefits are received by the caregiver for the child.

Hospital, clinic, Public Health, Medicaid or food stamp records showing the relationship between the caregiver and the child.

Hospital, clinic, Public Health, or Medicaid records where a caregiver’s authorization to give approval for services such as shots was acceptable.

Division of Services for Children, Youth and their Families’ records specifying the relationship between the caregiver and child.

Division of Services for Children, Youth and their Families’ records showing that the caregiver is the contact for this child.

Military or veterans records which specify relationship

Or other documents as approved by the school district.

Or other documents as approved by the school district.

**History**
- *4 DE Reg. 1016 (12/1/00)*

##### **16 Del. Admin. Code § 8101-3.0** Reasonable effort to locate the parent(s), guardian, or custodian of the child shall include option 1 (3.1), which is required, and a choice of either option 2 (3.2), 3 (3.3), or 4 (3.4). {#sec-8101-3.0 omnilex-key=us-de-regs-official--title-16--8101-3.0}

3.1 Certified mail receipt of a written notice from the caregiver that he or she intends to take school responsibility for the child. The notice should be sent to the last known address of the parent(s), custodian, or guardian. Proof of this step will be the notice and the return receipt saying that the letter was not deliverable because no one by that name lives at this address.

3.2 The caregiver or someone acting in his or her place makes an actual visit to the last known address of the parent(s), custodian, or guardian. The individual making this visit will need to describe what was found at this address and to whom he or she spoke regarding the missing parent(s), custodian, or guardian.

3.3 Contact with social service agencies, place of employment, health care provider, or friends verified by a written statement signed by that party confirming that the location of the parent(s), custodian, or guardian is unknown.

3.4 Other documents or confirmations that show the parent(s), custodian, or guardian cannot be found.

**History**
- *4 DE Reg. 1016 (12/1/00)*

##### **16 Del. Admin. Code § 8101-4.0** Affidavit {#sec-8101-4.0 omnilex-key=us-de-regs-official--title-16--8101-4.0}

4.1 Delaware Health and Social Services will develop the Caregivers’ School Authorization form. Anyone who wishes to obtain this form may do so by contacting their local school district office or Delaware Health and Social Services, Division of Services for Aging and Adults with Physical Disabilities (DSAAPD). Only the Caregivers’ School Authorization form developed by DSAAPD shall be used.

**History**
- *4 DE Reg. 1016 (12/1/00)*

#### **8102** Delegation of Power of Relative Caregivers to Consent to Medical Treatment of Minors

##### **16 Del. Admin. Code § 8102-1.0** Definitions for terms used in 13 DelC. §707(a) {#sec-8102-1.0 omnilex-key=us-de-regs-official--title-16--8102-1.0}

Medical treatment does not include treatment in an inpatient mental health facility.

Disease – a pathological condition of a body part, an organ, or a system resulting from various causes, such as infection, genetic defect, or environmental stress, and characterized by an identifiable group of signs or symptoms or life.

Pathology – the medical science concerned with all aspects of disease with an emphasis on the essential nature, causes, and development of abnormal conditions, as well as with the structural and functional changes that result from disease processes. It is also the anatomical or functional manifestations of a disease.

Public clinics include school wellness centers.

This authorization also applies to medical care provided in schools that do not have wellness centers as well as medical care required at school-related activities.

**History**
- *4 DE Reg. 1014 (12/1/00)*

##### **16 Del. Admin. Code § 8102-2.0** Definition for terms used in 13 Del.C. §708 {#sec-8102-2.0 omnilex-key=us-de-regs-official--title-16--8102-2.0}

2.1 Affidavit of Establishment of Power to Relative Caregivers to Consent to Medical Treatment of Minors (also known as Caregivers’ Medical Authorization) – An affidavit of written or printed declaration or statement of facts, made voluntarily, and confirmed by the oath or affirmation of the party making it, and taken by a licensed notary.

**History**
- *4 DE Reg. 1014 (12/1/00)*

##### **16 Del. Admin. Code § 8102-3.0** Reasonable effort to locate the parent(s), guardian, or custodian of the child shall include option 1 (3.1) , which is required, and a choice of either option 2 (3.2), 3 (3.3), or 4 (3.4). {#sec-8102-3.0 omnilex-key=us-de-regs-official--title-16--8102-3.0}

3.1 Certified mail receipt of a written notice from the caregiver that he or she intends to take medical responsibility for the child. The notice should be sent to the last known address of the parent(s), custodian, or guardian. Proof of this step will be the notice and the return receipt saying that the letter was not deliverable because no one by that name lives at this address.

3.2 The caregiver or someone acting in his or her place makes an actual visit to the last known address of the parent(s), custodian, or guardian. The individual making this visit will need to describe what was found at this address and to whom he or she spoke regarding the missing parent(s), custodian, or guardian.

3.3 Contact with social service agencies, place of employment, health care provider, or friends verified by a written statement signed by that party confirming that the location of the parent(s), custodian, or guardian is unknown.

3.4 The caregiver places a legal notice in the News Journal and the Delaware State News informing the parent(s), custodian, or guardian of (child's name) ____________________ that the caregiver intends to take educational responsibility of the child. Eight days after publication describe what happened. Include the response you received or the lack of response. Attach a copy of the legal notice, being sure to include the portion of the newspaper with the date the notice was printed.

3.5 Other documents or confirmations that show the parent(s), custodian, or guardian cannot be found.

**History**
- *4 DE Reg. 1014 (12/1/00)*

##### **16 Del. Admin. Code § 8102-4.0** Affidavit {#sec-8102-4.0 omnilex-key=us-de-regs-official--title-16--8102-4.0}

4.1 Delaware Health and Social Services will maintain the Caregivers’ Medical Authorization form. Anyone who wishes to obtain this form may do so by contacting their local State Service Center, Public Health clinic, or the Division of Services for Aging and Adults with Physical Disabilities (DSAAPD) or their local school district office.

**History**
- *4 DE Reg. 1014 (12/1/00)*

### **9000** Division for the Visually Impaired

#### **9101** Rules and Regulations of the Statewide Contracts to Support Employment for Individuals with Disabilities

##### **16 Del. Admin. Code § 9101-1.0** General Provisions {#sec-9101-1.0 omnilex-key=us-de-regs-official--title-16--9101-1.0}

1.1 The name of this entity is the Commission for Statewide Contracts to Support Employment for Individuals with Disabilities (“Commission”).

1.2 The mailing address of the Commission is the Biggs Building, 1901 North DuPont Highway, New Castle, Delaware 19720, and the telephone number is 302-255-9800.

1.3 The Commission shall assure an expanded and constant market for products and services of individuals with disabilities. To that end, the Commission will approve proposed contracts and set the price of all products manufactured and services provided by Delaware Industry for the Blind (“DIB”) or any community rehabilitation program (CRP) that are being offered to a State agency as defined in 16 Del.C. Ch. 96.

1.4 The Officers of the Commission shall be a Chair (appointed by the Governor) and a Vice-Chair (elected by the members of the Commission).

1.5 The Chair shall preside at all meetings of the Commission. The Chair shall be the only person authorized to make public announcements for the Commission. The Chair may request from the head or administrator of any state agency, as defined in 16 Del.C. Ch. 96, to provide information necessary to enable the Commission to carry out its duties pursuant to the same chapter. The Chair shall also appoint members to all subcommittees of the Commission. The Chair shall designate members of the Commission to represent the Commission upon all affiliated associations, committees, and organizations; at meetings; and the like. The Chair may also appoint non-Commission members to any subcommittee where he/she deems the person’s experience will assist that subcommittee with its responsibilities.

1.6 The Vice-Chair shall be vested with all powers and shall perform all the duties of the Chair in his/her absence or disability, to the extent which may be permitted by law, and the Vice-Chair shall perform such other duties as may be prescribed from time to time by the Commission.

1.7 The Director of the Division for the Visually Impaired (Director) shall provide administrative services to the Commission. The Director will designate someone to provide administrative assistance at all Commission and all subcommittee meetings and shall record the proceedings of the meetings and shall be responsible for creating the minutes of each meeting. The Director shall give proper notice of all meetings of the Commission and of all of the subcommittees.

1.8 The Director shall supervise and direct the execution of all policies, orders, and resolutions of the Commission as may be required of him/her by the Commission.

1.9 The Commission shall be composed of the following serving, at the pleasure of the Governor, as voting members with majority members present to rule when voting:

1.9.1 Director of Government Support Services or a designee;

1.9.2 Director of the Division of Vocational Rehabilitation or a designee;

1.9.3 Secretary of Finance or a designee;

1.9.4 Three public members, which shall include at least one person with a disability or a family member of an individual who is 14 years of age or older and has a disability, who are appointed by the Governor;

1.9.5 The Chair, who shall be appointed by the Governor;

1.9.6 Non-voting members who shall consist of the following:

1.9.6.1 A representative of an industry that employs persons with disabilities, appointed by the Governor;

1.9.6.2 The Director of the Delaware Association of Rehabilitation Facilities, Inc. (d/b/a A.N.D.) or its successor; and

1.9.6.3 The Director of the Division for the Visually Impaired.

1.10 Members of the Commission shall serve without compensation other than reimbursement for expenses actually incurred in connection with the work of the Commission, and for travel expenses when away from their homes or regular places of business.

1.11 There are no set terms for the members of the Commission.

**History**
- *20 DE Reg. 986 (06/01/17)*

##### **16 Del. Admin. Code § 9101-2.0** Meetings {#sec-9101-2.0 omnilex-key=us-de-regs-official--title-16--9101-2.0}

2.1 The Commission shall meet once each month; provided, however, that a majority of a quorum present at any such meeting may postpone or change the date of the next monthly meeting.

2.2 A special meeting of the Commission may be called at any time by the Chair.

2.3 A written notice of each regular meeting of the Commission shall be electronically transmitted by the Director of the Division for the Visually Impaired or his/her designee to each member of the Commission at least seven (7) days prior to the date of such regular meeting. Notice shall be electronically transmitted by the Director of the Division for the Visually Impaired or his/her designee to each member of the Commission at least two (2) days prior to the date of any special meeting which may be duly called, as aforesaid.

2.4 A majority of the voting members of the Commission shall constitute a quorum for the transaction of business. Pursuant to 16 Del.C. §9603(j), members of the Commission may participate in a meeting of the Commission by means of conference telephone or other communications equipment by which all persons participating in the meeting can hear each other. Participating in the meeting in this manner shall constitute presence in person at the meeting.

2.5 No meeting of the Commission shall be only telephonic. There will be at least one voting member present in the physical location where the public may attend in person.

2.6 All Commission meetings shall offer the public the ability to attend the meeting telephonically by including a toll free number in its public notices.

2.7 It shall be the duty of the members of the Commission to attend the meetings of the Commission so as to take part in its deliberations. If any appointed member fails to attend three successive meetings of the Commission without good and valid cause or excuse or without leave of absence from the Chair, or if the Chair for any cause cannot act, from the Vice Chair of the Commission, that member’s office shall be declared vacant by the Commission, and the Chair shall notify the Governor of a vacancy on the Commission, and request that the Governor shall fill the same.

2.8 New Commission members shall complete an orientation session designated by the Chair.

2.9 All Commission members shall participate in training session as designated by the Chair.

2.10 At all meetings of the Commission or any subcommittee thereof, all proceedings shall be conducted in accordance with the Delaware Freedom of Information Act, 29 Del.C. Ch. 100 and the Delaware Administrative Procedures Act, 29 Del.C. Ch. 101, as applicable.

**History**
- *20 DE Reg. 986 (06/01/17)*

##### **16 Del. Admin. Code § 9101-3.0** Conflicts of Interest {#sec-9101-3.0 omnilex-key=us-de-regs-official--title-16--9101-3.0}

3.1 Any member of the Commission or subcommittee member having an interest in a matter presented to or being considered by the Commission or a subcommittee for recommendation, authorization, approval or ratification, shall give prompt, full and frank disclosure of his or her interest to the Commission or subcommittee prior to its acting on such matter. The body to which such disclosure is made shall thereupon determine by majority vote, whether the disclosure shows that a conflict of interest exists or can reasonably be construed to exist.

3.2 If the body to which the disclosure is made determines that a conflict exists, the person regarded as having the conflict shall not vote on, nor use his or her personal influence on, nor participate (other than to present factual information or to respond to questions) in the discussions or deliberations with respect to such matter. Such person may not be counted in determining the existence of a quorum for the portion of the meeting where the matter that includes the conflict is under discussion or is being voted upon. The minutes of the meeting shall reflect the disclosure made, the vote thereon, and where applicable, the abstention from voting and participation, and whether a quorum was present.

**History**
- *20 DE Reg. 986 (06/01/17)*

##### **16 Del. Admin. Code § 9101-4.0** Order of Business {#sec-9101-4.0 omnilex-key=us-de-regs-official--title-16--9101-4.0}

4.1 The order of business at all regular meetings of the Commission shall be as follows:

4.1.1 Call to Order;

4.1.2 Approval of Minutes of Previous Meeting(s);

4.1.3 Old Business;

4.1.4 New Business;

4.1.5 Report of the Chair;

4.1.6 Report(s) of the Subcommittee(s);

4.1.7 Other Report(s);

4.1.8 Public Comment(s) or Presentation(s); and

4.1.9 Adjournment;

4.2 The Chair shall have the authority to deviate from the order of business as the circumstances warrant.

4.3 Members of the public may speak only during the time that has been designated as “public comment/presentation” under the agenda and only after they have been recognized by the Chair. Members of the public may also speak outside this designated time period but only with the permission of the Chair. Presentations by members of the public shall be limited to five (5) minutes, unless otherwise approved by the Chair. Speakers are requested to give their presentations in the order of sign in. The Chair may limit the number of public speakers heard, as circumstances warrant.

**History**
- *20 DE Reg. 986 (06/01/17)*

##### **16 Del. Admin. Code § 9101-5.0** Subcommittees {#sec-9101-5.0 omnilex-key=us-de-regs-official--title-16--9101-5.0}

5.1 The subcommittees of the Commission shall be as follows:

5.1.1 The Regulations Subcommittee; and

5.1.2 Central Non-Profit Agency (CNA) Subcommittee.

5.2 In December of each year, the Chair shall review the composition of each of the subcommittees, shall make appointments and/or reassign members of the Commission to each of the subcommittees, as needed and permitted by law, and shall name a Chair of each of the subcommittees to serve for the following calendar year. Each member of the Commission shall participate actively in the work of one of the subcommittees. Non-members of the Commission may be appointed by the Chair pursuant to subsection 1.5 of these regulations. Those appointed non-members shall count towards the quorum of that subcommittee and shall have a vote in any matter before the subcommittee. Quorum for any subcommittee shall be a majority of that subcommittee’s members.

5.3 The Chair may appoint special or ad hoc committees at any time and from time to time.

5.4 The Regulations Subcommittee shall review and revise, when appropriate, the Commission’s Regulations to ensure that they are compliant with the Commission’s purpose and statutory authority. It will review any recommendations made regarding the regulations.

5.5 The CNA Subcommittee shall develop the competitive solicitation for the selection of any central non-profit agency. In addition, the subcommittee shall review the performance of the CNAs as well as review and respond to any complaint filed against a CNA with the Commission. The subcommittee will present its findings and recommendations on any complaint to the Commission.

**History**
- *20 DE Reg. 986 (06/01/17)*

##### **16 Del. Admin. Code § 9101-6.0** Annual Report {#sec-9101-6.0 omnilex-key=us-de-regs-official--title-16--9101-6.0}

6.1 Not later than 90 days following the close of each fiscal year, the Commission shall transmit to the Governor and to the General Assembly a report in a format as required by law or executive order. The report shall include the names of the Commission members serving the preceding fiscal year, the dates of the Commission meetings in that year, a description of its activities during that year, and any recommendations for changes in the law which the Commission might suggest.

6.2 The Chair may designate the initial drafting of the Annual Report to an ad hoc committee and the Commission shall vote on the final draft prior to its issuance to the Governor and General Assembly.

**History**
- *20 DE Reg. 986 (06/01/17)*

##### **16 Del. Admin. Code § 9101-7.0** Amendments {#sec-9101-7.0 omnilex-key=us-de-regs-official--title-16--9101-7.0}

7.1 At any time, anyone, whether a Commissioner or member of the public, who wishes to propose amendments to these regulations shall send such proposal in writing to the Chair of the Regulations Subcommittee who will present the proposal to the subcommittee for their review and consideration.

7.2 A copy of any proposed amendment(s) of these regulations as recommended by the subcommittee shall be forwarded by electronic transmittal to each member of the Commission at least ten (10) days prior to the meeting of the Commission at which it is to be presented and acted upon, together with a written notice of the date, hour, and place of such meeting.

7.3 Any amendments of these regulations must first be adopted by affirmative vote of two-thirds of the seated voting members of the Commission before the same shall become effective.

**History**
- *20 DE Reg. 986 (06/01/17)*

#### **9102** Regulations for Set Aside Contracts

##### **16 Del. Admin. Code § 9102-1.0** General Provisions {#sec-9102-1.0 omnilex-key=us-de-regs-official--title-16--9102-1.0}

The Commission for Statewide Contracts to Support Employment for Individuals with Disabilities (the "Commission") is established by Chapter 96 of Title 16 of the Delaware Code. The purpose of these regulations is to guide the Commission in its work of enabling, through set aside contracts, the employment of Delaware citizens who are visually impaired or who have other disabilities.

**History**
- *21 DE Reg. 424 (11/01/17)*

##### **16 Del. Admin. Code § 9102-2.0** Definitions {#sec-9102-2.0 omnilex-key=us-de-regs-official--title-16--9102-2.0}

The following words and terms, when used in these regulations, have the following meaning unless such terms are otherwise defined in the Delaware Code or unless the context clearly indicates otherwise. Words used in the singular number include the plural, and the plural includes the singular. Words importing the masculine gender include the feminine as well and all singular terms will include the plural, except as otherwise clearly indicated by the context.

"Central nonprofit agency" or "CNA" means any nonprofit entity under 26 U.S.C. §501 that is organized under the laws of the State of Delaware and that the Commission selects to do at least one of the tasks set forth in either 16 Del.C. §9602(3)a or §9602(3)b.

"Community rehabilitation program" or "CRP" means any entity that provides or coordinates rehabilitation services for individuals with visual impairments and other disabilities, including assessment, customized employment, medical, personal assistance, psychiatric, psychological, rehabilitation technology, supported employment, or vocational services. A CRP typically will contract with a state agency, such as the Division of Vocational Rehabilitation, the Division for the Visually Impaired, the Division of Substance Abuse and Mental Health, the Division of Developmental Disabilities Services, or the Division of Services for Aging and Adults with Physical Disabilities, to provide assistance to eligible individuals according to their needs in all areas of community participation, including the assistance individuals may need to obtain and keep employment.

"Fair market value" means the price, service level, quality, and life cycle costing for a product or service that is commercially reasonable when compared to the open market.

"Government Support Services" or "GSS" means the section of the Office of Management and Budget that is established by and has all of the powers, duties, and functions set forth in 29 Del.C. §6308A.

"Procurement list" means the list of formally negotiated contacts by Government Support Services for the purchase of products or services as reference in 16 Del.C. §9604(d).

"Set-aside contract" means a formal, negotiated agreement between one or more CNAs or CRPs and Government Support Services for a service or product that has been exempted from the procurement process under Chapter 69 of Title 29 of the Delaware Code and awarded by the Commission for a price that the Commission has approved.

**History**
- *21 DE Reg. 424 (11/01/17)*

##### **16 Del. Admin. Code § 9102-3.0** Selection, Accountability, and Funding of CNAs {#sec-9102-3.0 omnilex-key=us-de-regs-official--title-16--9102-3.0}

3.1 CNA Selection. The Commission shall designate one or more CNAs for a three-year period, after which each designated CNA may apply to renew its designation for another three years. Applications for CNA status may be made to the Commission between March 1st and April 30th and between September 1st and October 31st of each calendar year. The CNA selection criteria shall be reviewed and revised periodically by the Commission. Nevertheless, an applicant must demonstrate the following minimum criteria:

3.1.1 Its tax-exempt non-profit entity status under 26 U.S.C. §501 and under similar state income tax codes. Such status must be verified by providing proper documentation;

3.1.2 Its ability to manage contracts within the State of Delaware;

3.1.3 Its expertise in the employment of persons with visual impairments or other disabilities, which may include evidence of its history of providing job opportunities to such persons;

3.1.4 Its capacity to fulfill the duties of a CNA, as described in subsection 3.2 of these regulations; and

3.1.5 Its ability to fulfill the duties of a CNA as shown by letters of reference from CRPs with which it intends to subcontract.

3.2 Duties of the CNAs. The responsibilities of the CNAs shall include, but not be limited to, the following:

3.2.1 Recruiting and assisting CRPs in developing and submitting proposals for set aside contracts for suitable products and services;

3.2.2 Facilitating the distribution of subcontracts among CRPs;

3.2.3 Managing and coordinating the deliverables of service under set aside contracts, including quality assurance and general administration of subcontracts with CRPs;

3.2.4 Handling complaints and ongoing customer relations with agencies of this State;

3.2.5 Educating and training CRPs to improve the quality and cost-effectiveness of services described in set aside contracts;

3.2.6 Promoting the increase in supported employment opportunities for persons who are visually impaired or who have other disabilities;

3.2.7 Marketing products and services to potential consumers;

3.2.8 Researching and developing products and services;

3.2.9 Producing content that the Commission may consider for inclusion in its annual report and in other public relations materials or submitting information to the Commission that may be included in the Commission's annual report;

3.2.10 Preparing accurate purchase orders and invoices for those set aside contracts mentioned by the CNA;

3.2.11 Making payments to CRPs in a timely manner; and

3.2.12 Other duties as designated by the Commission.

3.3 Semi-annual Reviews. The Commission or its designee shall conduct semi-annual reviews of the services provided by CNAs to determine whether the CNAs have fulfilled the duties listed in subsection 3.2 of these regulations. The Commission shall use as the basis for its reviews the work and performance of the CNAs as documented in its meeting minutes from regularly-scheduled meetings or as documented in other materials that have been provided upon the Commission's request. The reviews must be completed between March 1st and April 30th and between September 1st and October 31st of each calendar year. If the Commission notes any deficiencies in the performance of a CNA, the Commission will negotiate with the CNA a mutually-agreeable corrective action plan.

3.4 CNA Management Fees. CNA management fees must be included as part of any approved set aside contract price for products or services. Invoices will be paid according to the contract price. Agreements between CNAs and CRPs regarding management fees charged by the CNAs may be reviewed annually by the Commission. Subsection 5.7 of these regulations provides guideline for CNAs and CRPs with regard to fair market value.

3.5 CRP Affiliation Prohibited. CNAs shall not require CRPs to pay membership dues in order for CRPs to be assigned a subcontract under set aside contracts held by the CNAs.

3.6 Direct Contracting by CRPs. CRPs may receive set aside contracts directly from the Commission or from the State if the CRPs' personnel can fulfill the duties normally expected of a CNA as described in subsection 3.2 of these regulations.

3.7 State Agency CNAs. The Division for the Visually Impaired will fulfill the duties of a CNA for the Delaware Industries for the Blind. Other state agencies may apply to be considered as CNAs by the Commission if the agencies can fulfill the duties of CNAs as described in subsection 3.2 of these regulations.

**History**
- *21 DE Reg. 424 (11/01/17)*

##### **16 Del. Admin. Code § 9102-4.0** Duties of the CRPs {#sec-9102-4.0 omnilex-key=us-de-regs-official--title-16--9102-4.0}

4.1 The responsibilities of the CRPs shall include, but not be limited to, the following:

4.1.1 Recruiting and assisting individuals with disabilities for opportunities and job placement in set aside contracts for suitable products and services;

4.1.2 Facilitating the distribution of opportunities for individuals with disabilities among established set aside contracts;

4.1.3 Managing and coordinating the deliverables of service under set aside contracts, including quality assurance and general administration of set aside contracts they hold or through the CNA on whose behalf they are performing services;

4.1.4 Handling complaints and ongoing customer relations with agencies of this State when directly contracted and through their CNAs when subcontracted;

4.1.5 Educating and training individuals with disabilities to improve the quality and cost-effectiveness of services described in set aside contracts;

4.1.6 Promoting the increase in supported employment opportunities for persons who are visually impaired or who have other disabilities;

4.1.7 Marketing products and services to potential consumers;

4.1.8 Researching and developing products and services;

4.1.9 Producing content that the Commission may consider for inclusion in its annual report and in other public relations materials or submitting information to the Commission that may be included in the Commission's annual report;

4.1.10 Preparing accurate purchase orders and invoices for those set aside contracts under which they are operating; and

4.1.11 Other duties as designated by the Commission.

**History**
- *21 DE Reg. 424 (11/01/17)*

##### **16 Del. Admin. Code § 9102-5.0** Set Aside Contract Requests {#sec-9102-5.0 omnilex-key=us-de-regs-official--title-16--9102-5.0}

5.1 All set aside contract requests submitted by a CRP, its designed CNA, or both, if applicable, must provide all relevant information required by the Commission.

5.2 Agencies and community service providers who desire to participate in set aside contract requests need to provide verification that they are a CRP as defined by Delaware law. A CNA is responsible for ensuring that CRPs with which it subcontracts meet the requirements for participation.

5.3 When a CNA or a CRP wants to develop and research a new product or service for a set aside contract, the CNA or CRP may submit to the Commission a "Request for Assignment." The form set forth in Section 9.0 must be used when requesting an assignment.

5.4 The period allowed for developing the new product or service should not exceed twelve (12) months.

5.5 At the end of a development period, the CNA or CRP must present the assigned product or service to the Commission for its consideration as a set aside contract. If the CNA or CRP does not request a set aside contract at that time, then the CNA or the CRP may request a time extension. If a CNA or a CRP requests a time extension, the Commission may approve a six-month extension by a majority vote at a regularly-scheduled and convened meeting and shall document such granted time extension.

5.6 In keeping with the scope and purpose of 16 Del.C. Ch. 96, the Commission, designated CNAs, and any CRPs assigned to a set aside contract must assure that persons who are visually impaired or who have other disabilities as defined by the Americans with Disabilities Act of 1990 (ADA) will perform 75% of all direct labor for service-based contracts and 50% of all direct labor for product-based contracts. A phase-in plan may be requested by the CNA or the CRP, and any such approved phase-in plan will start at 25% less than the direct labor requirements, with that percentage increased to the required minimum standards as soon as possible, but no less than eighteen (18) months into the term of the set aside contract.

5.7 The Commission will typically consider products or services proposed to it if the price of the product or service is within 10% or less of the amount the State is currently paying, or if the price is 10% or less than or within the fair market value.

5.8 If two CRPs or CNAs request a set aside contract for the same service or product at the same time, the Commission will determine which agency is best prepared to provide the service or product by evaluating each CNA based on criteria delineated in subsections 3.1 and 3.2 and by evaluating each CRP based on the criteria delineated in subsection 4.1.

**History**
- *21 DE Reg. 424 (11/01/17)*

##### **16 Del. Admin. Code § 9102-6.0** Information for a Set Aside Contract {#sec-9102-6.0 omnilex-key=us-de-regs-official--title-16--9102-6.0}

6.1 The designated CNA and CRP must provide the following information when requesting a set aside contract for a particular product or service:

6.1.1 A copy of a specification or a clear description of the product or service, including samples of products, when appropriate.

6.1.2 A verification of the fair market value and employment impact, which may include:

6.1.2.1 Obtaining the most recent state bidding or award information;

6.1.2.2 Providing commercial or competitive price information; and

6.1.2.3 Identifying the anticipated number of people who will be employed by the set aside contract.

6.2 Based on a majority vote, and after it has assured itself that the designed CNA and/or CRP has provided it with all of the necessary information, the Commission will review and respond to the CNA and/or CRP regarding the acceptability of the proposal for a set aside contract.

**History**
- *21 DE Reg. 424 (11/01/17)*

##### **16 Del. Admin. Code § 9102-7.0** Approved Set Aside Contracts {#sec-9102-7.0 omnilex-key=us-de-regs-official--title-16--9102-7.0}

7.1 To approve a set aside contract request, the majority of the members present at two properly-noticed and convened public meetings of the Commission must vote upon the request. If the request is deemed to be an urgent circumstance, the majority of the Commission members may vote to waive the waiting period and may approve the set aside contract request at one properly-noticed and convened public meeting.

7.2 Once the Commission has approved a set aside contract, it shall notify in writing GSS and the CRP, CNA, or both regarding the approval and provide to GSS a copy of the set aside contract.

7.3 GSS shall add the approved set aside contract to the procurement list of products and services and shall publish the procurement list on the State's "My Marketplace" website portal or on any other state electronic procurement advertising system.

7.4 The Commission, a CNA, a CRP, or GSS may recommend that a product or service be removed from the procurement list after the Commission has documented that the product or service is no longer needed. The removal of any product or service from the procurement list will depend on an analysis provided by GSS and on GSS' protocols for making such changes.

7.5 Set Aside Contract Promotion. In keeping with the scope and purpose of 16 Del.C. Ch. 96, the Commission may promote the purchase of products and services that are within approved set aside contracts and ensure that approved set aside contracts are published on the procurement list that is circulated to all State agencies and other government entities in the State of Delaware. The Commission, CRPs, and designated CNAs may monitor available spend data for State agencies to determine whether or not the products and services offered through the procurement list are procured from the set aside contract holder.

**History**
- *21 DE Reg. 424 (11/01/17)*

##### **16 Del. Admin. Code § 9102-8.0** Changes to an Established Set Aside Contract {#sec-9102-8.0 omnilex-key=us-de-regs-official--title-16--9102-8.0}

8.1 After an initial set aside contract has been established, the State or a CRP and/or its designated CNA may request the following changes:

8.1.1 Price Changes and Modifications. The request must verify fair market value and employment impact by:

8.1.1.1 Providing written substantiation for a price modification;

8.1.1.2 Obtaining the most recent state bidding or award information;

8.1.1.3 Providing commercial or competitive price information;

8.1.1.4 Submitting a new cost analysis that highlights changes from the original set aside contract; and

8.1.1.5 Providing updated or new information on the number of people employed by the set aside contract.

8.2 Transfer of Set Aside Contract. From time to time it may be necessary for a CNA or a CRP to cease performing a service or providing a product that is the subject of a set aside contract.

8.2.1 If the contract is held by a CNA, the CNA may transfer the set aside contract to a different CRP as long as no modifications are made to the set aside contract. The CNA shall notify the Commission at its next regularly-scheduled meeting that the CNA has transferred the set aside contract to a different CRP.

8.2.2 If the transfer of the set aside contract is from one CNA to another CNA, the transfer must be ratified by a majority vote of Commission members that are present at the next regularly-scheduled Commission meeting.

8.2.3 If a CRP abandons a set aside contract or is unable to fulfill its contractual duties under a set aside contract, the CPR must immediately notify the Commission and Government Support Services.

8.2.4 The transferring and receiving CRP and/or designated CNA must develop a detailed plan for the transfer of a set aside contract to ensure that there will be no disruption of service.

**History**
- *21 DE Reg. 424 (11/01/17)*

##### **16 Del. Admin. Code § 9102-9.0** Request for Assignment Form {#sec-9102-9.0 omnilex-key=us-de-regs-official--title-16--9102-9.0}

The following shall be the "Request for Assignment" form that must be used by a CNA or a CRP that wants to develop and research a new product or service for a set aside contract:

AGENCY:

________________________

DATE:

________________________

LIST PRODUCT(S) AND/OR SERVICE(S) TO BE ASSIGNED FOR DEVELOPMENT:

__________________________________________

__________________________________________

__________________________________________

ESTIMATED TIME NEEDED TO DEVELOP:

__________________________________________

COMMENTS:

__________________________________________

__________________________________________

__________________________________________

ASSIGNMENT DATE:

________________________

NAME / TITLE:

________________________

________________________

REQUESTING AUTHORITY:

________________________

________________________

**History**
- *21 DE Reg. 424 (11/01/17)*

##### **16 Del. Admin. Code § 9102-10.0** Effective Date {#sec-9102-10.0 omnilex-key=us-de-regs-official--title-16--9102-10.0}

This regulation is effective ten days after publication in the Delaware Register of Regulations.

**History**
- *21 DE Reg. 424 (11/01/17)*

### **Division of Social Services** Division of Social Services

#### **Delaware Social Services Manual** Delaware Social Services Manual

#### **1000** Administration

##### **16 Del. Admin. Code § 1000** DEFINITIONS {#sec-1000 omnilex-key=us-de-regs-official--title-16--1000}

The following words and terms, when used in this regulation, will have the following meaning unless the context clearly indicates otherwise.

Civil rights

A civil right is an enforceable right or privilege, which if interfered with by another gives rise to an action for injury. Examples of civil rights are freedom of speech, press, assembly, the right to vote, freedom from involuntary servitude, and the right to equality in public places.

Civil Rights Coordinator

A Division of Social Services staff person who ensures that employees of the Division, who have direct contact with applicants and recipients, carry out the requirements of the Civil Rights Program. The Coordinator also maintains complete records of all complaints that are made and/or appeals and fair hearings that are requested on the grounds of discrimination.

Discrimination

The unlawful and intentional act of unfair treatment of a person based on race, color, ethnicity, sex (gender), sexual orientation, gender identity, religious creed, national origin, physical or mental disability, political beliefs, retaliation, limited English proficiency (LEP), and/or age.

Guardian ad litem

An individual appointed by the courts to represent the best interests of a minor child.

Law enforcement officer

Any official who has the authority to arrest individuals. Officials with arrest powers include police officers, constables, and in Delaware, parole and probation officers.

Limited English proficient

Individuals who do not speak English as their primary language and who have a limited ability to read, write, speak or understand English may be limited English proficient.

Means tested programs

Programs that provide cash, benefits or services to people who meet a test of need based on income and assets

**History**
- *12 DE Reg. 453 (10/01/08)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *12 DE Reg. 453 (10/01/08)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 869 (02/01/13)*
- *16 DE Reg. 869 (02/01/13)*

##### **16 Del. Admin. Code § 1000-1001** RESERVED {#sec-1000-1001 omnilex-key=us-de-regs-official--title-16--1000-1001}

**History**
- *12 DE Reg. 453 (10/01/08)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *12 DE Reg. 453 (10/01/08)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 869 (02/01/13)*
- *16 DE Reg. 869 (02/01/13)*

##### **16 Del. Admin. Code § 1000-1002** TREATING CLIENTS WITH COURTESY {#sec-1000-1002 omnilex-key=us-de-regs-official--title-16--1000-1002}

31 Delaware Code §501

This policy applies to all Division of Social Services (DSS) and Division of Medicaid and Medical Assistance (DMMA) staff when providing services to individuals seeking or receiving services from the Division of Social Services.

DSS and DMMA staff will treat clients in a manner that is polite, helpful, and respectful of the dignity of each individual.

**History**
- *12 DE Reg. 453 (10/01/08)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *12 DE Reg. 453 (10/01/08)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 869 (02/01/13)*
- *16 DE Reg. 869 (02/01/13)*

##### **16 Del. Admin. Code § 1000-1003** KEEPING CLIENT INFORMATION CONFIDENTIAL {#sec-1000-1003 omnilex-key=us-de-regs-official--title-16--1000-1003}

7 CFR 272.1(c); 45 CFR 205.50, 31 Del. Code §1101

This policy applies to all DSS and DMMA staff who have access to public assistance information and records.

1. Staff Safeguards Public Assistance Information

Public assistance information and records may be used only for purposes directly connected with the administration of public assistance programs. All information gathered about individuals or families for public assistance purposes is considered confidential and will be safeguarded by DSS and DMMA.

The Divisions will not release any information regarding an individual without the individual's written consent.

Exceptions:

1. DSS may give the address of a cash assistance recipient to a law enforcement agency in certain situations. See DSSM 1003.2.

2. DSS may give information about food benefit applicants and recipients to a law enforcement agency in certain situations. See DSSM 1003.2.1.

3. General information about expenditures, numbers of clients served, and other statistical information is a matter of public record and is available to any interested party.

1003.1 RESERVED

1003.2 RELEASING CONFIDENTIAL TANF RECIPIENT INFORMATION

45 CFR 205.50 (a)(1)(v), PRWORA, 31 Del. Code §1101

This policy applies whenever a law enforcement agency requests confidential information about a TANF cash assistance recipient. Only the address of the recipient may be released.

1. Law Enforcement Officer Must Request Confidential Information

The address of a TANF recipient may be released to a law enforcement officer if the officer requests the information. The officer must tell the agency that the individual:

A. Is fleeing to avoid prosecution

B. Is a fleeing felon (or in the case of New Jersey is fleeing from conviction of a high misdemeanor)

C. Is violating a condition of probation or parole or

D. Has information that is necessary for the officer to conduct his or her official duties

2. Operations Administrator Releases Information

Only the Operations Administrator (OA) has the authority to release the address of a TANF cash assistance recipient to a law enforcement officer. The OA may delegate this authority to a designee.

1003.2.1 RELEASING CONFIDENTIAL FSP CLIENT INFORMATION

7 CFR 272.1(c)(1); PRWORA, 31 Del. Code §1101

This policy applies whenever a law enforcement agency makes a written request for confidential information about a food benefit applicant or recipient.

1. Only the Information Necessary to Comply With a Specific Written Request May Be Released

2. Operations Administrators May Release Information

Only the Operations Administrator (OA) has the authority to release information about a Food Supplement Program (FSP) applicant or recipient household to a law enforcement officer. The OA may delegate this authority to a designee.

3. Requests Must Meet Specific Criteria

The request must be in writing and include:

A. The identity of the individual requesting the information.

B. The individual's authority to request the information.

C. The violation being investigated.

D. The identity of the person on whom the information is requested.

4. Restrictions Apply to Information Released

DSS can release the following about a food benefit household member

A. Address

B. Social security number

C. Photograph, if available

D. Household member information that is useful and necessary in apprehending or investigating another household member who has fled to avoid felony prosecution or custody, or who has violated a condition of probation or parole.

5. DSS Will Terminate the Food Benefits on Proof of Legal Violations

If the law enforcement officer provides verification that a household member is fleeing to avoid prosecution or custody for a felony, or has violated a condition of probation or parole, DSS will terminate the member’s participation.

1003.3 REPORTING CHILD ABUSE AND NEGLECT

45 CFR 205.50 (a)(1)(i)(G)

This policy applies to all DSS and DMMA staff. It applies any time a DSS or DMMA worker suspects a home is unsuitable because of abuse, neglect, or exploitation of a child.

The worker will make a report to the Division of Family Services whenever the worker suspects a home is unsuitable due to abuse, neglect, or exploitation of a child.

1003.4 RELEASING CONFIDENTIAL INFORMATION TO COURT APPOINTED SPECIAL ADVOCATES

31 Delaware Code §3610

This policy applies any time a Court Appointed Special Advocate (or guardian ad litem) requests information about a child and his parent or guardian and provides pertinent details of the reasons for the release of information.

DSS and DMMA staff will permit a Court Appointed Special Advocate (or guardian ad litem) to review and/or copy any records relating to the child and his or her parent or guardian. (The CASA does not have to have the consent of the child or the child’s family.)

Any time information is released, staff will:

A. Document pertinent details of the reasons for the release of information.

B. Send written notification of this release to the last known address of the individual to whom the record refers.

1003.5 OTHER REASONS FOR RELEASING CONFIDENTIAL INFORMATION

This policy applies any time persons or groups other than law enforcement or Court Appointed Special Advocates make a request for confidential information. It also applies if the information is being released for reasons other than reporting suspected abuse, neglect or exploitation of a child. This policy applies to DSS and DMMA staff.

1. Staff Release Information Needed in Connection with Public Assistance Programs

Staff may release public assistance program information if needed in connection with the administration of DHSS plans or programs for any of the following reasons:

A. Investigations

B. Prosecutions

C. Criminal proceedings

D. Civil proceedings

2. Staff Release Information Needed to Administer Federal Means Tested Programs

Staff may release information if it is needed for the administration of any federal or federally assisted program.

The program must provide assistance (in cash or in kind) or services directly to individuals on the basis of need.

Staff must assure that the information will remain confidential and will be used only to pursue services for the individual. Other means-tested programs include the

3. Staff May Release Information to Other Agencies

Staff will release information to other agencies only with written permission of the recipient. Examples of other agencies are Children & Families First, Catholic Social Services, Legal Aid, etc.

4. Staff Release Information to Other Governmental Agencies

Lists of recipients may be released to other governmental agencies if the information will be used to perform services for DSS or DMMA and the agency can assure that the information will remain confidential.

**History**
- *12 DE Reg. 453 (10/01/08)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *12 DE Reg. 453 (10/01/08)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 869 (02/01/13)*
- *16 DE Reg. 869 (02/01/13)*

##### **16 Del. Admin. Code § 1000-1004** SAFEGUARDING CASE RECORDS {#sec-1000-1004 omnilex-key=us-de-regs-official--title-16--1000-1004}

45 CFR 205.50(a)(3)(ii)

This policy applies to all DSS and DMMA case records.

Case records are kept in locked file cabinets except when the files are in use. The records must be returned to the files before the office closes for the day. Electronic case records are maintained in a secure data system.

Records sent to another office may be sent in the custody of a Division employee or by Department messenger mail. DSS and DMMA records in electronic form are not transferred between offices.

**History**
- *12 DE Reg. 453 (10/01/08)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *12 DE Reg. 453 (10/01/08)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 869 (02/01/13)*
- *16 DE Reg. 869 (02/01/13)*

##### **16 Del. Admin. Code § 1000-1005** COMPILING AND SAVING CASE RECORD CONTENTS {#sec-1000-1005 omnilex-key=us-de-regs-official--title-16--1000-1005}

45 CFR 92.42

This policy applies to all DSS and DMMA case records except medical records.

1. Staff Collect Pertinent Case Information

Case records will contain all information necessary to determine eligibility or ineligibility for benefits or amount of benefits. Records will contain:

A. The date of application

B. Date and basis of the eligibility decision

C. Facts essential to determining initial and continuing eligibility

D. The basis for terminating or reducing assistance or services

E. Information regarding overpayments and claims

F. A copy of the Criminal Justice Report if the case was referred to the Department of Justice for prosecution.

2. Division of Management Services Maintains Fiscal Records

The Division of Management (DMS) maintains an accounting system and supporting fiscal records adequate to assure that claims for federal funds are in accord with applicable federal requirements.

3. Staff Save Case Records

Case records are kept for five or more years as follows:

A. Public Assistance records are kept for five years from the date of closure.

B. Records related to a pending audit are kept beyond the five years or until the completion of a successful audit, whichever is later.

C. Records of non-expendable property which was purchased with federal grant funds are kept for five years after final disposition of the property.

D. Cases that are under investigation by the Department of Justice (DOJ) or that have outstanding overpayments will be retained for ten years and will remain intact until the investigation and subsequent legal action is complete or the overpayment is filed.

4. Staff Save Information About Uncollected Overpayments and DOJ Cases

Staff must never destroy information needed to substantiate outstanding overpayments.

Cases with outstanding overpayments are kept intact until the overpayment is filed.

Cases under investigation by the Department of Justice (DOJ) are kept intact until the investigation and subsequent legal action is complete.

5. Staff Purge Case Records

Any papers (forms or correspondence) in an active record which are more than four calendar years old may be destroyed on site with the permission of the unit supervisor who has possession of the record if those papers were scanned into the Document Imaging System.

Exception: Do not destroy records of permanent value, e.g., birth certificates, deeds, trusts, contracts, or other records of value.

**History**
- *12 DE Reg. 453 (10/01/08)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *12 DE Reg. 453 (10/01/08)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 869 (02/01/13)*
- *16 DE Reg. 869 (02/01/13)*

##### **16 Del. Admin. Code § 1000-1006** GUARANTEEING CIVIL RIGHTS AND NON-DISCRIMINATION {#sec-1000-1006 omnilex-key=us-de-regs-official--title-16--1000-1006}

Title VI of the Civil Rights Acts of 1964, §504 of the Rehabilitation Act of 1973, 45 CFR Part 80, 84, 90, and 92; 7 CFR 272.6(a), 42 CFR §440.262

This policy applies to any person who inquires about, applies for or receives any services from Division of Social Services (DSS) or Division of Medicaid and Medical Assistance (DMMA). It includes the use of all DSS or DMMA physical facilities. For this policy, the terms DSS or DMMA include all other persons or organizations that perform services for either Division.

1. Division Director Ensures Rights are Upheld

The DSS or DMMA Director, acting through administrative staff, coordinates the Division's Civil Rights Program. The Director ensures all staff comply with the requirements of the program.

The Director ensures that all aspects of the program are understood and implemented by staff members.

The Director ensures that all individuals asking about, applying for or receiving DSS or DMMA services are freely informed of their rights of protection against discrimination and their right to complain in any case of discrimination.

2. Staff Development and Training Unit Emphasizes Civil Rights

The Staff Development and Training Unit emphasizes the role of the Civil Rights Program in all services provided to individuals, especially as it relates to the rights and privileges of each individual.

The Staff Development and Training Program emphasizes that all applicants and recipients, and all persons receiving any care or services from or through the Division, will not be subject to discrimination of any kind on the grounds of race, color, national origin, sex, sexual orientation, gender identity, religious creed, age, disability, political beliefs, limited English proficiency (LEP),and/or retaliation.

3. Staff Protect Civil Rights

DSS and DMMA staff protect the civil rights of persons asking about, applying for or receiving any Division service.

4. Staff Do Not Discriminate

Staff do not discriminate against any person on the grounds of race, color, national origin, age, sex, sexual orientation, gender identity, disability, political beliefs, religious creed, retaliation, or any other form of discrimination.

DSS and DMMA do not directly or indirectly (through contracts or other arrangements) on the grounds of race, color, national origin, age, sex, sexual orientation, gender identity, disability, political beliefs, religious creed, and/or retaliation:

A. Deny any person a DSS or DMMA service.

B. Subject any person to segregation or separate treatment in any matter related to his or her receipt of services.

C. Restrict any person's use of privileges enjoyed by others receiving Division services.

D. Treat any person differently from others in determining if that person satisfies any condition of eligibility that all persons must meet in order to qualify for services.

1006.1 ENSURING NON-DISCRIMINATION IN THE PROVISION OF SERVICES

Title VI of the Civil Rights Acts of 1964, §504 of the Rehabilitation Act of 1973, 45 CFR Part 80, 84, 90, and 92; 7 CFR 272.6(a); 42 CFR §440.262

This policy applies when any person inquires about, applies for, or receives services from the Division of Social Services (DSS) or the Division of Medicaid and Medical Assistance (DMMA) or a person or organization under contract with DSS or DMMA.

1. All Classes of People May Participate in any DSS or DMMA Program

2. DSS and DMMA Do Not Discriminate

Neither the Division nor its contractors will discriminate against any person because of race, color, national origin, sex, sexual orientation, gender identity, religious creed, age, disability, political beliefs, limited English proficiency (LEP), and/or retaliation.

DSS and DMMA will not discriminate:

A. In the type of services provided.

B. Against any class of people.

C. Regardless of the class of people to which services will be provided.

D. Regardless of the situation in which services will be provided.

1006.2 RESERVED

1006.3 PROVIDING CIVIL RIGHTS INFORMATION

This policy applies to any individual who seeks or receives services or information from the Division of Social Services (DSS) or the Division of Medicaid and Medical Assistance (DMMA).

1. Staff Provide Information on Non-Discrimination

Staff will provide information about non-discrimination statutes and policies within ten days of request. (The information can be found at DSSM 1006.6 and DSSM 1006.1.)

Staff will advise individuals how to file a discrimination complaint (as per DSSM 1007) if they wish to file one.

Staff will provide individuals with our online civil rights complaint form if the individual wishes to make a civil rights complaint.

2. Staff Provide Information on Fair Hearings and Civil Rights

Staff will give all applicants a copy of Form 113, Information on Fair Hearings and Civil Rights.

3. DSS and DMMA Publicize the FSP Complaint Procedures

All offices will display the non-discrimination poster provided by FNS. The Division will also publicize the FSP complaint procedures.

1006.4 ASSURING COMPLIANCE IN AREA OPERATIONS

Title VI of the Civil Rights Acts of 1964, §504 of the Rehabilitation Act of 1973, 45 CFR Part 80, 84, 90, and 92; 7 CFR 272.6(a); 42 CFR §440.262

This policy applies to all Division of Social Services (DSS) or Division of Medicaid and Medical Assistance (DMMA) staff and vendors/contractors any time a service is provided to an applicant or recipient.

1. Management Assures Compliance by Staff and Vendor/Contractors

Staff are instructed by Management, during training and the normal course of work activity, to be alert to instances of discrimination.

Vendors and contractors are notified in their contract that all services provided on behalf of DSS must be provided without discrimination on account of race, color, national origin, sex, sexual orientation, gender identity, religious creed, age, disability, political beliefs, limited English proficiency (LEP), and/or retaliation. They are also notified that payment will not be made unless such services are provided without discrimination.

If staff notice any instances of discrimination, staff will make a full written report to the Director via his or her Supervisor and the Civil Rights Coordinator.

3. Civil Rights Coordinator Maintains Records of Complaints

The Civil Rights Coordinator maintains complete records of all complaints that are made on the grounds of discrimination. He also maintains complete records of all appeals and fair hearings that are requested on the grounds of discrimination.

1006.5 REPORTING CIVIL RIGHTS PROGRAM ACTIVITIES

45 CFR Part 80; 7 CFR 272.6(a)

This policy applies any time a person, group, or agency makes a complaint alleging a civil rights violation.

1. Civil Rights Coordinator Reports on Civil Rights Activities

The Civil Rights Coordinator will prepare and submit required reports on all aspects of the Civil Rights Program, including:

A. Complaints of discrimination received

B. Appeals to the Division

C. Appeals to the Department of Health and Human Services

D. Verification of discrimination

E. Action taken and the results

2. Reports of FSP Complaints are Sent to FNS

All complaints of discrimination in the Food Supplement Program processed at the State level must be sent to FNS within 90 days of the date DSS receives the complaint.

The report must contain the following information if available to the Division:

A. Name, address, and telephone number of the person alleging discrimination.

B. Reason for the alleged discrimination.

C. Nature and date of the incident or action that led the person to allege discrimination.

D. Names and addresses of persons who may have knowledge of the discriminatory act(s).

3. Civil Rights Information is Made Available Upon Request

Upon request, the Civil Rights Coordinator provides:

A. Correspondence between DSS and other agencies.

B. Communications on Civil Rights issues.

C. Access to records and facilities (to representatives of the Department of Health and Human Services) for purposes of verifying compliance with the Civil Rights Act and Department of Health and Human Services Regulations.

1006.6 PUBLICIZING THE CIVIL RIGHTS PROGRAM

Title VI of the Civil Rights Acts of 1964, §504 of the Rehabilitation Act of 1973, 45 CFR Part 80, 84, 90, and 92; 7 CFR 272.6(a); 42 CFR §440.262

This policy applies when publicizing information about the Division of Social Services’ (DSS’) Civil Rights Program.

DSS Informs the Public of the Civil Rights Program

The DSS Civil Rights policy is available on the State website at www.dhss.delaware.gov/dss. The agency also displays posters in all its offices notifying all persons that assistance and services are provided to all eligible persons without regard to race, color, national origin, sex, sexual orientation, gender identity, age, religious creed, disability, political beliefs, limited English proficiency (LEP), and/or retaliation.

The Director will provide speakers from the administrative staff of the Department to any organization interested in learning more about the Civil Rights Program.

1006.7 RESERVED

**History**
- *12 DE Reg. 453 (10/01/08)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *12 DE Reg. 453 (10/01/08)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 869 (02/01/13)*
- *16 DE Reg. 869 (02/01/13)*

##### **16 Del. Admin. Code § 1000-1007** MAKING CIVIL RIGHTS COMPLAINTS {#sec-1000-1007 omnilex-key=us-de-regs-official--title-16--1000-1007}

Title VI of the Civil Rights Acts of 1964, §504 of the Rehabilitation Act of 1973, 45 CFR Part 80, 84, 90, and 92; 7 CFR 272.6(a); 42 CFR §440.262

This policy applies to any person, group or agency inquiring about, applying for or receiving any Division of Social Services (DSS) or Division of Medicaid and Medical Assistance (DMMA) provided service who believes he or she has been the victim of discrimination based on of race, color, national origin, sex, sexual orientation, gender identity, religious creed, age, disability, political beliefs, limited English proficiency (LEP), and/or retaliation.

1. Complaints Must be Written

Persons must submit the complaint in writing within 180 days of the alleged discriminatory act. They may also file an appeal and ask for a fair hearing if not satisfied with a decision of the Division. See DSSM 5000.

2. Complaints Contain Specific Information

Exception: Complaints involving the Food Supplement Program are also accepted verbally. However, the complaint must be reduced to writing for record keeping purposes.

A. Cash, Medical, and Child Care Assistance Complaints must describe:

Complaints must describe:

1. The kind of discrimination alleged (e.g., race, color, etc.)

2. When and where the discrimination took place

3. Any important facts and circumstances connected with the alleged discrimination

The complaint must be signed by the person making the complaint.

B. Food Benefit Assistance Complaints

Complaints must contain:

1. The name, address, and telephone number of the person alleging discrimination.

2. The name and location of the office or organization accused of the discriminatory practice.

3. The nature of the incident or acts which resulted in the allegation.

4. The date(s) of the incident.

5. The names of persons who have knowledge of the alleged discriminatory acts.

6. The type of alleged discrimination (e.g., race, color, etc.).

1007.1 RESERVED

1007.3 ROUTING CIVIL RIGHTS COMPLAINTS

Title VI of the Civil Rights Acts of 1964, §504 of the Rehabilitation Act of 1973, 45 CFR Part 80, 84, 90, and 92; 7 CFR 272.6(a); 42 CFR §440.262

This policy applies any time a complaint is filed against the Division of Social Services (DSS) and/or Division of Medicaid and Medical Assistance (DMMA) alleging discrimination on account of race, color, national origin, sex, sexual orientation, gender identity, religious creed, age, disability, political beliefs, limited English proficiency (LEP), and/or retaliation.

1. Civil Rights Coordinator Routes Complaints

The Civil Rights Coordinator will study and evaluate all complaints alleging discrimination and route them to the appropriate official.

When a complaint is received the Coordinator will forward:

A. Food Supplement complaints to the Regional Office of the United States Department of Agriculture.

B. Medicaid complaints to the Secretary of the Department of Health and Human Services (DHSS).

C. All other DSS complaints to the Division Director.

D. All other DMMA complaints to the Division Director.

1007.4 KEEPING RECORDS OF CIVIL RIGHTS COMPLAINTS

Title VI of the Civil Rights Acts of 1964, §504 of the Rehabilitation Act of 1973, 45 CFR Part 80, 84, 90, and 92; 7 CFR 272.6(a); 42 CFR §440.262

This policy applies to all complaints of discrimination based on race, color, national origin, sex, sexual orientation, gender identity, religious creed, age, disability, political beliefs, limited English proficiency (LEP), and/or retaliation.

The Civil Rights Coordinator keeps records of all civil rights complaints received by the Division of Social Services (DSS). Records of civil rights complaints will show:

A. Action(s) taken on the complaint.

B. Any investigation conducted.

C. Findings.

D. Any subsequent action.

1007.5 KEEPING THE IDENTITY OF COMPLAINANTS CONFIDENTIAL

7 CFR 272.1(c); 45 CFR 205.50

This policy applies to any individual or group who files a complaint with the Division of Social Services or the Division of Medicaid and Medical Assistance.

1. Staff Will Safeguard the Identity of any Person Making a Complaint.

Exception: The identity of a complainant may be disclosed if necessary to take care of the complaint.

1007.6 MAKING COMPLAINTS

This policy applies to any person, group or agency applying for or receiving any DSS or DMMA service who wishes to file a complaint. It does not apply to complaints based on discriminatory practices or complaints that may be pursued through a fair hearing.

1. Applicants and Recipients May File Complaints

2. Customer Relations Manager Processes Complaints

**History**
- *12 DE Reg. 453 (10/01/08)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *12 DE Reg. 453 (10/01/08)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 869 (02/01/13)*
- *16 DE Reg. 869 (02/01/13)*

##### **16 Del. Admin. Code § 1000-1008** PROVIDING POLICY INFORMATION {#sec-1000-1008 omnilex-key=us-de-regs-official--title-16--1000-1008}

This policy applies to all policy manuals and other policy information issued by the Division of Social Services (DSS) or the Division of Medicaid and Medical Assistance (DMMA).

1. Policy Information is Available for Inspection

Policy information includes:

A. Rules and regulations governing eligibility.

B. The need for and the amount of assistance granted by DSS or DMMA.

C. Recipients' rights and responsibilities.

D. All services offered by DSS or DMMA.

2. State Office Provides Copies of Policy Information

A current copy of the policy manuals and other policy material is available without charge to Public Libraries and to individuals or other agencies who request the material if they:

A. Are accessible to the recipient population they serve.

B. Accept responsibility for filing all amendments and changes forwarded by the Division.

3. Staff Make Copies of Policy Information for Fair Hearings

A. Fair Hearings:

If requested, staff will make copies of specific policy material for an applicant, recipient, or his representative to determine whether a fair hearing should be requested or to prepare for a fair hearing. There is no cost for these copies.

B. Other Reasons:

If requested, staff will make copies of the policy manual and other policy material for any individual who requests such material. The individual is charged by the page for the copies at the current Division established rate for photo copies. The first 20 pages of standard-sized, black and white copies are free of charge.

**History**
- *12 DE Reg. 453 (10/01/08)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *12 DE Reg. 453 (10/01/08)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 869 (02/01/13)*
- *16 DE Reg. 869 (02/01/13)*

##### **16 Del. Admin. Code § 1000-1009** Arranging Interpreter and Translation Services for Limited English Proficient Individuals {#sec-1000-1009 omnilex-key=us-de-regs-official--title-16--1000-1009}

This policy applies to individuals who have limited English proficiency and require the services of an interpreter or translator to provide information to, or receive information from DSS.

DSS Workers Arrange for Interpreter Services

DSS provides interpreter services to limited English proficient individuals who need an interpreter. The receptionist will identify the need for services when the individual arrives at the office. Bilingual staff or a contracted vendor will provide the services. A listing of contracted vendors is available in the Interpreter and Translation Services Administrative Notice.

DSS Workers Arrange for Translation Services

DSS translates forms and documents into languages common in Delaware. This includes translating an application for our customers. The DSS Worker will send requests for document or form translation to the DSS Policy Unit. See the Interpreter and Translation Services Administrative Notice.

**History**
- *12 DE Reg. 453 (10/01/08)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *12 DE Reg. 453 (10/01/08)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 869 (02/01/13)*
- *16 DE Reg. 869 (02/01/13)*

##### **16 Del. Admin. Code § 1000-1010** Arranging Services for Individuals with Hearing Impairments {#sec-1000-1010 omnilex-key=us-de-regs-official--title-16--1000-1010}

This policy applies to individuals who have a hearing impairment and require auxiliary aids or services to provide information to, or receive information from DSS.

DSS Supervisors Arrange for Sign Language Interpreters

DSS provides sign language interpreters or other auxiliary aids for individuals who have a hearing impairment. The receptionist will identify the need for services or auxiliary aids when the individual arrives at the office. Use of these services or auxiliary aids must be approved by the Supervisor.

A contracted vendor will provide the individual with effective communication services. A listing of contracted vendors is available in the Interpreter and Translation Services Administrative Notice.

**History**
- *12 DE Reg. 453 (10/01/08)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *12 DE Reg. 453 (10/01/08)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *20 DE Reg. 726 (03/01/17)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 1191 (05/01/13)*
- *16 DE Reg. 869 (02/01/13)*
- *16 DE Reg. 869 (02/01/13)*

#### **2000** Case Processing Procedures

##### **16 Del. Admin. Code § 2000** Applying for Assistance {#sec-2000 omnilex-key=us-de-regs-official--title-16--2000}

7 CFR 273.2, 45 CFR 206.10, 45 CFR 98.1 (b)(1)

An application for assistance allows DSS to determine an applicant's eligibility for benefits.

1. Any individual interested in applying for benefits may receive, complete, and submit a DSS application for assistance.

A. Applications are available at all DSS locations and online.

B. The applicant or an agency, institution, guardian, or other person acting for the applicant (with the applicant’s knowledge and consent) may submit an application in writing or electronically.

C. DSS will:

i. Maintain a daily log at each location to record the names of individuals who request an application.

ii. Inform applicants of their:

2. The applicant has primary responsibility for providing verification of eligibility; however, DSS will assist the applicant when necessary.

3. DSS will compare the applicant’s income and need for the calendar month in which assistance is requested. DSS will use the applicant’s available resources at the time of application in determining eligibility.

4. DSS will process applications in accordance with Division standards when a completed and signed application is submitted to DSS and the applicant completes an interview with a DSS case worker.

2000.1 Submitting Applications

Applicants must submit a completed and signed application or Request for Assistance to DSS to begin the process for determining eligibility for benefits.

1. Applicants applying for benefits:

A. May obtain and submit an application at a DSS location or online.

B. May submit an application on the same day as they make initial contact with DSS.

C. May submit a Request for Assistance by completing and signing page one of the application.

D. May be assisted by an individual (age 18 or older) of the applicant’s choice in the application

process.

E. Will be assisted by DSS in completing the application process if the applicant requires a

reasonable accommodation.

F. Will be offered a copy of the DHSS Program Information and Rights and Responsibilities.

2. DSS date stamps, screens, and processes submitted applications according to Division

standards.

A. The screening process includes a search for prior DSS case activity, assignment of a Master

Client Index (MCI) number, and an eligibility check for expedited food benefit services.

B. DSS will interview the applicant (in person or via telephone) the same day the completed

application is submitted. If the interview cannot be conducted on the same day, DSS will

schedule an interview with the applicant for a later date.

C. DSS will instruct applicants who submit a Request for Assistance to complete the remainder of

the application and bring it to their scheduled intake interviews.

Related policies:

DSSM 2000.5

2000.2 Conducting Interviews

DSS must interview individuals applying for assistance before eligibility for benefits can be determined.

1. DSS will conduct applicant interviews promptly to ensure that applications are processed according to Division standards.

A. DSS will conduct applicant interviews either in person or by telephone (as indicated by the program).

B. DSS will offer interpretation services to applicants with limited English proficiency and will provide an interpreter through the Division’s contracted language service upon request or when deemed necessary. The person who serves as the interpreter:

i. Must be age 18 or older,

ii. Must sign the signature page of the application, and

iii. Is preferably an interpreter available through the Division’s contracted language service.

C. DSS will schedule an interview and will give Form 105 “Appointment and Request for Verification” to all applicants who are unable to be interviewed on the same day that they submit an application.

D. DSS must schedule timely interviews with applicants who qualify for expedited food benefits to ensure that benefits can be issued within the expedited processing deadlines.

E. DSS offices will maintain a daily log of all applications received, interviews scheduled, and cases processed.

Related policies:

DSSM 2000.5, 9041, 14100.3

2000.3 Recording Applications

Each DSS office must maintain a daily log to record when applications are received.

1. DSS offices will:

2000.4 Determining Application Status

DSS will process all filed applications for benefits and will promptly send a notice of the determination to the applicant.

1. DSS determines applications as follows:

2000.5 Non-Medical Assistance Filing Dates and Processing Standards

DSS will approve eligible applicants and send notice of acceptance as soon as possible, but no later than thirty (30) days following the application filing date. The filing date is the date the applicant completes, signs, and returns at least the first page of the application form to the correct DSS location.

Applicants who are ineligible will be sent a denial notice as soon as possible, but not later than thirty (30) days following the application filing date. If the applicant has failed to appear for an interview and has made no subsequent contact with the agency, DSS will send a denial notice on the 30th day following the application date. The applicant must file a new application to be reconsidered for benefits.

In cases where verification is incomplete, the applicant must provide missing verification by the 30th day following the application filing date. If verification is not provided by that date, the application is denied unless this deadline does not allow the applicant at least ten (10) days to return information. (This will occur when the application interview is held 21 or more days after the application is filed.) In these situations, the application can pend beyond thirty (30) days to allow at least ten (10) days for return of missing verification.

In all cases, the client must be informed via Form 105 of the verification that is needed and of the last day that it will be accepted. The application may continue to pend for an additional ten (10) days if the client has returned all verification originally requested and is asked to obtain further verification as a result of agency error. In that situation, the application is approved when the additional verification is submitted, but benefits are issued from the date that the original verification was submitted. If verification is not provided by the deadline, a denial notice is sent to the applicant.

In cases where there is a pending claim for cash benefits (e.g., U.C.), the worker must find out if a decision regarding the claim will be made within thirty (30) days from the application filing date. If a decision is anticipated in that timeframe, the application is not approved until the decision is reached. In those cases, income from the approved claim is included when determining financial eligibility and the amount of the grant. If a decision is not anticipated within the thirty (30) day period, the worker must determine eligibility based on the clients current situation and set a control to check the claim when a decision is anticipated.

In situations where an applicant is ineligible in the month of application, but will be eligible in subsequent months because of anticipated changes, the same application is used to deny benefits in the month of application and determine eligibility in the month following the month of application. In such instances the client need not reapply.

2000.6 Supplemental Applications

For cash assistance cases in which an individual is being added to an existing open assistance unit, add the person to the unit effective the date that the new member was reported to DSS. A separate face-to-face interview will not be required, but when adding the individual review eligibility factors such as income, resources, and relationship. DSS will verify that the individual resides in the home. DSS will add the individual to the most recent application with a note listing the date of report. A prorated supplemental cash assistance benefit will be issued effective the date the person was added to the assistance unit.

When an individual is being opened in a new assistance unit, the payee will need to add that person to the most recent application. In this case, the signature of the payee on the application will be required. DSS will review the application for eligibility. A prorated cash assistance benefit will be issued from the date the individual was opened.

Adding newborns to the assistance unit is effective the date of the child's birth whether or not the payee needs to resign the most recent application.

Example: Mrs. Jones is open in an A1 case with her two children. On 5/15, she reports that she had a baby born on 5/14. DSS will add the baby to the most recent application and request verification for eligibility. The baby is added to her A1 case effective 5/14. A TANF supplement is issued from 5/14 - 5/31. The Food Stamp supplement is issued from 5/1 - 5/31.

Example: Mrs. Jones is open in an A1 case with two of her children. On 6/13 she reports that her 14 year old son is no longer living with his father but living with her. DSS will add her son to the most recent application and review for eligibility. Her son is added to the TANF assistance unit and the Food Stamp household effective the date of report which is 6/13. A TANF supplemental benefit is issued from 6/13 - 6/30. The Food Stamp supplement is issued from 6/1 - 6/30.

Example: Mrs. Jones and her children are open in an A1 case. On 3/23 she reports that her niece is now living with her. DSS will set up an A2 case for her niece with Mrs. Jones as payee. DSS will add the niece to the most recent application. DSS will need to review eligibility factors and have Mrs. Jones resign the application. The effective date of the cash assistance benefit is when the eligibility factors have been reviewed, verified, and the application has been signed by Mrs. Jones.

For Food Stamps, add the individual to the household effective the first of the month in which the new household member was reported to DSS. A full supplement is issued for the month a new household member is added to the food stamps. Food Stamp supplements cannot be prorated during a certification period. DSS will need to verify eligibility factors even though a new application and signature by the payee is not required.

**History**
- *18 DE Reg. 139 (08/01/14)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *18 DE Reg. 139 (08/01/14)*
- *9 DE Reg. 1368 (03/01/06)*
- *13 DE Reg. 661 (11/01/09)*
- *8 DE Reg. 1153 (2/1/05)*
- *9 DE Reg. 1756 (5/1/06)*
- *9 DE Reg. 1756 (5/1/06)*
- *15 DE Reg. 1025 (01/01/12)*
- *18 DE Reg. 142 (08/01/14)*
- *10 DE Reg. 1007 (12/01/06)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *9 DE Reg. 1370 (03/01/06)*
- *16 DE Reg. 874 (02/01/13)*
- *10 DE Reg. 1441 (03/01/07)*
- *24 DE Reg. 1009 (05/01/21)*
- *7 DE Reg. 647 (11/01/03)*
- *15 DE Reg. 1616 (05/01/12)*
- *21 DE Reg. 722 (03/01/18)*

##### **16 Del. Admin. Code § 2000-2001** Redeterminations {#sec-2000-2001 omnilex-key=us-de-regs-official--title-16--2000-2001}

A redetermination is a process by which eligibility factors are periodically reviewed to determine if they assistance group remains eligible for benefits.

2001.1 Redetermination: Eligibility Review Periods

Eligibility periods means the period of time within which a family is eligible to receive benefits. At the expiration of each eligibility period cash assistance benefits end. Further eligibility is established based upon a newly completed application, an interview and verification of information. Under no circumstance will benefits continue beyond the end of an eligibility period without a new determination of eligibility. The first month of the eligibility period is the first month for which the household is eligible to participate.

A redetermination is due when the eligibility period is expiring. The recipient must complete a new DSS application form and an interview. The interview may be in person or over the phone. When the client says he/she cannot get a requested document, the worker will assist him/her in obtaining an acceptable verification. A redetermination is complete when all eligibility factors are examined and a decision regarding eligibility is reached. The worker sets a new review period for eligible families.

The eligibility review periods for cash assistance cases will not exceed 12 months. If there are also Food Stamps to review, the cash assistance eligibility period will be adjusted to come due at the same time as the Food Stamp review. That means, the cash assistance redetermination will be done at the same time as the Food Benefit recertification.

If there is no open Food Benefit case but there is an open cash assistance group, the eligibility period of the new cash assistance group is adjusted to come due at the same time as the existing cash assistance group.

2001.1.1 Interviews

Delaware’s Temporary Assistance for Needy Families Program emphasizes work and work-related activity. Mandating face-to-face interviews might undermine that goal. Therefore, use mail-in applications, with a telephone interview, as an option to encourage recipients to continue employment and training activities or continue working. For Non-Needy Non-Parent Caretakers using mail-in applications with a telephone interview is also permitted since DSS does not count the income and resources of these caretakers. A Contract of Mutual Responsibility is still required to be reviewed and updated.

2001.1.2 Redetermination Notices

Families that have filed an application by the fifteenth (15th) day of the last month of their eligibility period must be provided with either a notice of eligibility or a notice of denial by the end of the current eligibility period. The end of the eligibility period means that a redetermination interview is due.

A system-generated notice is issued even if the assistance group’s benefit level increases or does not change.

If a family received a notice of expiration of when the eligibility period was ending indicating that a redetermination was due, and timely reapplied for cash assistance, they are to be sent another notice no later than 30 days after the review date. This second notice will indicate whether the family was eligible for benefits or denied benefits based on the information provided for the redetermination.

**History**
- *18 DE Reg. 139 (08/01/14)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *18 DE Reg. 139 (08/01/14)*
- *9 DE Reg. 1368 (03/01/06)*
- *13 DE Reg. 661 (11/01/09)*
- *8 DE Reg. 1153 (2/1/05)*
- *9 DE Reg. 1756 (5/1/06)*
- *9 DE Reg. 1756 (5/1/06)*
- *15 DE Reg. 1025 (01/01/12)*
- *18 DE Reg. 142 (08/01/14)*
- *10 DE Reg. 1007 (12/01/06)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *9 DE Reg. 1370 (03/01/06)*
- *16 DE Reg. 874 (02/01/13)*
- *10 DE Reg. 1441 (03/01/07)*
- *24 DE Reg. 1009 (05/01/21)*
- *7 DE Reg. 647 (11/01/03)*
- *15 DE Reg. 1616 (05/01/12)*
- *21 DE Reg. 722 (03/01/18)*

##### **16 Del. Admin. Code § 2000-2002** Changes in Circumstance For Cash Assistance {#sec-2000-2002 omnilex-key=us-de-regs-official--title-16--2000-2002}

Recipients are required to report significant changes that might affect their eligibility for cash assistance as soon as they are aware of such a change. Workers must instruct clients of this responsibility at the application interview and at each subsequent redetermination.

When a change is reported, workers will review eligibility in light of the new circumstance. If the change will result in ineligibility, the worker must take action to close the assistance case and send notice to the client at least ten (10) days prior to the effective date of the closing. (In some situations, ten (10) days advance notice is not required. See DSSM 5302 for a complete list of those situations. In those cases, notice of the change must be sent five (5) days in advance of the change.)

A significant change is defined as any of the following:

EXAMPLE: An applicant applies in May. The applicant is employed. The applicant is working 30 hours per week and earned $6.15 per hour. The best estimate of wages is calculated by multiplying 30 hours times $6.15 ($184.50 per week), then multiplying the weekly figure by 4.33 to determine the monthly income of $789.89.

If the change will not result in ineligibility, workers will proceed by:

Instructing the recipient to provide any necessary verification of the change within ten (10) days. Action is taken to effect the reported change prospectively. (See DSSM 2014). Refer to DSSM 9085 for reporting changes for Food Stamps.

2002.1.1 Case Closures

For Cash Assistance and Food Stamps:

The Division can terminate benefits if, based on reliable information, the following is true:

For Medical Assistance:

The Division can terminate benefits for an individual if, based on reliable information, the following is true:

2002.1.2 Change of Address Case Processing Instructions

Outlined below is a method for obtaining information from client and procedures for processing address changes.

A. Method - The method involves answering the questions of WHO, WHERE, WHEN, and WHAT.

1. WHO:

a. Identify all members of the Assistance Group (AG) or Household (HH) who are moving.

b. Determine the status of those who are not moving.

2. WHERE:

a. Establish the new address for the AG/HH. (Be sure to include the correct Postal Zip Code.)

b. Identify whether the AG/HH has moved into the dwelling/residence of another.

c. Identify whether another person is moving in with the AG/HH at the new address.

d. Determine whether the other person identified in (b) of (c) above is related to any member of the AG/HH.

If yes, determine the impact on client eligibility for continued benefits.

3. WHEN:

a. Establish when the move is/was effective.

4. WHAT:

a. Identify the new shelter expenses, including:

1) Rent/mortgage amount.

2) HUD subsidies.

3) Utilities (heat, cooling, water, etc., none).

4) Taxes.

5) Insurance.

6) Telephone.

b. Determine whether expenses are shared with another household.

B. Procedures

The following procedures are to be used when a client reports a change of address:

1. Initial Client Contact

a. Always verify identity of person reporting address change during both telephone and office contacts,

as follows:

1) Telephone Contact - Request caller to provide essential identifying data (i.e., Social Security Number,

Date of Birth, etc.)

2) Office Contact - When person is not known to you, request individual to provide essential identifying

data or verify identity by checking case record photo ID card.

b. Once identity is verified and no other verification has been provided, immediately process only the address change by entering information into DCIS; i.e., only the physical change of address.

NOTE: If the change cannot effect the benefit prior to deadline for the next scheduled benefit(s) issuance, offer the client the option of a benefit(s) hold. Document the client's decision on whether the benefit(s) is to be held. If the client elects to have the benefit(s) held, send message to DMS to hold.

REMEMBER: If the move is to a shelter for battered women and children, the household may receive an additional Food Stamp allotment as a separate household only once a month. (See DSS Manual Section 9707.)

c. Advise client verbally of what verification is necessary to complete the action and the deadline for presenting the verification. Hand-issue or mail the client the Form 105 to identify the required verification and the deadline [minimum of ten (10) days] for the receipt of the verification.

2. Follow-up Activities

a. When verification is not received prior to the deadline, determine continued eligibility based on known

facts.

b. Review for accuracy and document facts. If any discrepancy is identified, notify the client of what

information is needed to resolve and establish a new deadline.

c. Process the changes prospectively to effect the changes in shelter costs now.

d. Review DCIS to make sure correct information is in the system:

If the client owned the previous residence, review the disposition of any real property for appropriate eligibility determination of income and resources.

2002.2 Ineligibility Occurring After the First Day of the Month

When ineligibility occurs after the first day of the month, the cash assistance case must be closed the following month. Note: If the change is reported too late in the month to allow for advance notice to the recipient, the case is closed the next month. (See DSSM 5202 for exceptions to the advance notice requirement.)

The following action must be taken on the current month's benefits.

1. If ineligibility is the result of a strike, the payment must be recovered as outlined in DSSM 3025.

2. If ineligibility results because the recipient receives lump sum income, the payment must be recovered as an overpayment.

3. If ineligibility results because of an increase in income, the worker will determine if income received in the month it began was enough to render the unit totally ineligible. If so, the payment must be recovered in an overpayment.

4. If ineligibility occurs for another reason, the payment is not recovered.

**History**
- *18 DE Reg. 139 (08/01/14)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *18 DE Reg. 139 (08/01/14)*
- *9 DE Reg. 1368 (03/01/06)*
- *13 DE Reg. 661 (11/01/09)*
- *8 DE Reg. 1153 (2/1/05)*
- *9 DE Reg. 1756 (5/1/06)*
- *9 DE Reg. 1756 (5/1/06)*
- *15 DE Reg. 1025 (01/01/12)*
- *18 DE Reg. 142 (08/01/14)*
- *10 DE Reg. 1007 (12/01/06)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *9 DE Reg. 1370 (03/01/06)*
- *16 DE Reg. 874 (02/01/13)*
- *10 DE Reg. 1441 (03/01/07)*
- *24 DE Reg. 1009 (05/01/21)*
- *7 DE Reg. 647 (11/01/03)*
- *15 DE Reg. 1616 (05/01/12)*
- *21 DE Reg. 722 (03/01/18)*

##### **16 Del. Admin. Code § 2000-2003** Payee and Voluntary Protective Payee {#sec-2000-2003 omnilex-key=us-de-regs-official--title-16--2000-2003}

The payee for an assistance grant is the person in whose name checks are issued. A payee who is not included in the assistance unit is recorded as a "payee only" in the DCIS system. Payments issued to a "payee only" should be so designated. Instructions for issuing payments denoting "payee only" status can be found in the DCIS User Guide.

In TANF or GA, if both parents are in the home, the parents will decide who is designated as the payee.

In TANF or GA, persons may select "voluntary protective payees" if they are ill or hospitalized and unable to transact the check easily. Persons who are mentally retarded may select a "voluntary protective payee" if they are unable to transact financial matters without difficulty. The case record must indicate the reason for the selection. The names of both the voluntary protective payee and the client must appear on each application form.

The designation above is similar to the designation "Representative Payee" as used by the Social Security Administration and "Authorized Representative" as used in the Food Stamp Program.

The request for a "voluntary protective payee" must be in writing from the recipient to whom payment would otherwise be made in an unrestricted manner and must be recorded in the case record. The restriction must be discontinued promptly upon the written request of the recipient who initiated it. (ID card issuance procedure for voluntary protective payee - See DSSM 2022.1)

2003.1 Power of Attorney

A person may be severely disabled physically but still able to manage his affairs whether through his own efforts or with the help of another person to whom he may give a valid power of attorney to act for him in certain specified areas, such as endorsement of his assistance check. In such cases, the client shall be the designated payee and not the person granted the power of attorney.

**History**
- *18 DE Reg. 139 (08/01/14)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *18 DE Reg. 139 (08/01/14)*
- *9 DE Reg. 1368 (03/01/06)*
- *13 DE Reg. 661 (11/01/09)*
- *8 DE Reg. 1153 (2/1/05)*
- *9 DE Reg. 1756 (5/1/06)*
- *9 DE Reg. 1756 (5/1/06)*
- *15 DE Reg. 1025 (01/01/12)*
- *18 DE Reg. 142 (08/01/14)*
- *10 DE Reg. 1007 (12/01/06)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *9 DE Reg. 1370 (03/01/06)*
- *16 DE Reg. 874 (02/01/13)*
- *10 DE Reg. 1441 (03/01/07)*
- *24 DE Reg. 1009 (05/01/21)*
- *7 DE Reg. 647 (11/01/03)*
- *15 DE Reg. 1616 (05/01/12)*
- *21 DE Reg. 722 (03/01/18)*

##### **16 Del. Admin. Code § 2000-2004** Payment Dates {#sec-2000-2004 omnilex-key=us-de-regs-official--title-16--2000-2004}

Regular monthly grant payments are mailed to recipients on or around the first day of each month. Initial grant payments are mailed when assistance is authorized, and the payments are prorated from the date the eligibility is established.

**History**
- *18 DE Reg. 139 (08/01/14)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *18 DE Reg. 139 (08/01/14)*
- *9 DE Reg. 1368 (03/01/06)*
- *13 DE Reg. 661 (11/01/09)*
- *8 DE Reg. 1153 (2/1/05)*
- *9 DE Reg. 1756 (5/1/06)*
- *9 DE Reg. 1756 (5/1/06)*
- *15 DE Reg. 1025 (01/01/12)*
- *18 DE Reg. 142 (08/01/14)*
- *10 DE Reg. 1007 (12/01/06)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *9 DE Reg. 1370 (03/01/06)*
- *16 DE Reg. 874 (02/01/13)*
- *10 DE Reg. 1441 (03/01/07)*
- *24 DE Reg. 1009 (05/01/21)*
- *7 DE Reg. 647 (11/01/03)*
- *15 DE Reg. 1616 (05/01/12)*
- *21 DE Reg. 722 (03/01/18)*

##### **16 Del. Admin. Code § 2000-2005** Check Rounding {#sec-2000-2005 omnilex-key=us-de-regs-official--title-16--2000-2005}

All payments are rounded down by dropping the cents.

**History**
- *18 DE Reg. 139 (08/01/14)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *18 DE Reg. 139 (08/01/14)*
- *9 DE Reg. 1368 (03/01/06)*
- *13 DE Reg. 661 (11/01/09)*
- *8 DE Reg. 1153 (2/1/05)*
- *9 DE Reg. 1756 (5/1/06)*
- *9 DE Reg. 1756 (5/1/06)*
- *15 DE Reg. 1025 (01/01/12)*
- *18 DE Reg. 142 (08/01/14)*
- *10 DE Reg. 1007 (12/01/06)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *9 DE Reg. 1370 (03/01/06)*
- *16 DE Reg. 874 (02/01/13)*
- *10 DE Reg. 1441 (03/01/07)*
- *24 DE Reg. 1009 (05/01/21)*
- *7 DE Reg. 647 (11/01/03)*
- *15 DE Reg. 1616 (05/01/12)*
- *21 DE Reg. 722 (03/01/18)*

##### **16 Del. Admin. Code § 2000-2006** Grant Payment of Less Than $10 {#sec-2000-2006 omnilex-key=us-de-regs-official--title-16--2000-2006}

No assistance check, initial, regular, or supplemental is issued in an amount of less than $10. A recipient who is entitled to a payment under $10 will not receive a check, but is considered a recipient for other purposes.

**History**
- *18 DE Reg. 139 (08/01/14)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *18 DE Reg. 139 (08/01/14)*
- *9 DE Reg. 1368 (03/01/06)*
- *13 DE Reg. 661 (11/01/09)*
- *8 DE Reg. 1153 (2/1/05)*
- *9 DE Reg. 1756 (5/1/06)*
- *9 DE Reg. 1756 (5/1/06)*
- *15 DE Reg. 1025 (01/01/12)*
- *18 DE Reg. 142 (08/01/14)*
- *10 DE Reg. 1007 (12/01/06)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *9 DE Reg. 1370 (03/01/06)*
- *16 DE Reg. 874 (02/01/13)*
- *10 DE Reg. 1441 (03/01/07)*
- *24 DE Reg. 1009 (05/01/21)*
- *7 DE Reg. 647 (11/01/03)*
- *15 DE Reg. 1616 (05/01/12)*
- *21 DE Reg. 722 (03/01/18)*

##### **16 Del. Admin. Code § 2000-2007** Stop Payments for TANF, GA and RCA Benefits {#sec-2000-2007 omnilex-key=us-de-regs-official--title-16--2000-2007}

The following procedures are used to place a stop‑payment on a check that is reported by a client as lost, stolen, or not received by the 5th of the month.

1. The client must sign the Affidavit of Forgery and Request for Replacement of Lost Checks (Form 124) indicating that the check was not received, or was lost or stolen. Form 124 must have the benefit number and the benefit amount to be replaced. Form 124 is to have a notary signature.

2. The worker completes Form 230, Stop Payment or Rescind Payment for each TANF, General Assistance, and RCA check not received.

3. Form 230 and Form 124 are forwarded to DMS.

4. DMS investigates claims of checks that were not received, lost, or stolen. DMS will issue a replacement check to the recipient four working days after the receipt of the affidavit and Form 230, if the original check has not been cashed. (Note: In rare instances DMS will send a replacement check to the pool when requested. A reason must be given for distribution by the pool.)

**History**
- *18 DE Reg. 139 (08/01/14)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *18 DE Reg. 139 (08/01/14)*
- *9 DE Reg. 1368 (03/01/06)*
- *13 DE Reg. 661 (11/01/09)*
- *8 DE Reg. 1153 (2/1/05)*
- *9 DE Reg. 1756 (5/1/06)*
- *9 DE Reg. 1756 (5/1/06)*
- *15 DE Reg. 1025 (01/01/12)*
- *18 DE Reg. 142 (08/01/14)*
- *10 DE Reg. 1007 (12/01/06)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *9 DE Reg. 1370 (03/01/06)*
- *16 DE Reg. 874 (02/01/13)*
- *10 DE Reg. 1441 (03/01/07)*
- *24 DE Reg. 1009 (05/01/21)*
- *7 DE Reg. 647 (11/01/03)*
- *15 DE Reg. 1616 (05/01/12)*
- *21 DE Reg. 722 (03/01/18)*

##### **16 Del. Admin. Code § 2000-2008** Replacement Benefits - TANF, GA, RCA {#sec-2000-2008 omnilex-key=us-de-regs-official--title-16--2000-2008}

The client must sign the Affidavit of Forgery and Request for Replacement of Lost Check (Form 124) attesting to the loss and submit the affidavit to DSS within ten days of the report of the loss.

The household will not receive a replacement check if the affidavit is not received by DSS within ten days of the report of the loss. If the tenth day falls on a weekend or holiday, DSS will consider the affidavit as received timely if it is received on the next business day.

The household will not receive a replacement check if the date of request exceeds the stale date on the check. The stale date on checks is sixty (60) days from the date of the check..

DSS will issue replacement benefits within ten days of the reported loss or within four working days of receiving the affidavit, whichever is later.

The procedures listed below are followed in order to replace benefits. They apply to both closed and open cases.

1. The DCIS II screen that reflects the current status of the case (open or closed), Form 124, and Form 230 are sent to the Payment Section, DMS, Third Floor Annex, Administration Building, Herman M. Holloway, Sr. Health and Social Services Campus.

If the replacement is to be issued in an amount different from the original benefit, the pool supervisor must indicate on a separate sheet of paper the amount of the replacement benefit, the reason for the different amount and sign it.

Upon receipt of Form 124 and Form 230, the Payments Section will issue the benefit via the DCIS II system and mail it to the recipient. Note: In order to issue a replacement benefit for a closed case, the Payments Section will have to reopen the case. Once the replacement benefit has been issued, the Payments Section will return the case to a closed status. A DSS supervisor may grant reasonable extensions of the above ten-day limit based on good cause.

**History**
- *18 DE Reg. 139 (08/01/14)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *18 DE Reg. 139 (08/01/14)*
- *9 DE Reg. 1368 (03/01/06)*
- *13 DE Reg. 661 (11/01/09)*
- *8 DE Reg. 1153 (2/1/05)*
- *9 DE Reg. 1756 (5/1/06)*
- *9 DE Reg. 1756 (5/1/06)*
- *15 DE Reg. 1025 (01/01/12)*
- *18 DE Reg. 142 (08/01/14)*
- *10 DE Reg. 1007 (12/01/06)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *9 DE Reg. 1370 (03/01/06)*
- *16 DE Reg. 874 (02/01/13)*
- *10 DE Reg. 1441 (03/01/07)*
- *24 DE Reg. 1009 (05/01/21)*
- *7 DE Reg. 647 (11/01/03)*
- *15 DE Reg. 1616 (05/01/12)*
- *21 DE Reg. 722 (03/01/18)*

##### **16 Del. Admin. Code § 2000-2009** Holding Checks and Food Stamp Benefits {#sec-2000-2009 omnilex-key=us-de-regs-official--title-16--2000-2009}

1. Checks and/or Food Stamp benefits may be held at DMS after the DCIS processing deadline for the following reasons:

a. A change in circumstance in a cash assistance case is reported or discovered after the 20th of the month that will result in a reduction or termination of benefits.

If DSS has information confirming a circumstance that requires only adequate notice such as when a recipient has been committed to an institution, or when a child has been removed from the home as the result of a court action, the worker will reduce or terminate the benefit and send notice to the client. (See DSSM 5201). In these situations,10‑day advance notice is not required. If any other circumstance is reported that will result in a reduction or termination of benefits, the check may be held and canceled only if the client signs a written statement indicating that he/she understands that benefits will be reduced as a result of the information that was reported. If a statement is not signed by the client, the benefit cannot be reduced. Cash assistance clients must be informed that failure to sign such a statement could result in an overpayment.

NOTE: Changes in Food Stamp cases reported after the 20th of the month that result in a reduction or termination of benefits are always reflected in the Food Stamp budget the month following the next issuance. For example, a change reported on June 28th is reflected in August's issuance. In addition, the July benefit is not recoverable as a Food Stamp claim even if the change results in termination of the benefit. For this reason, benefits are not held when such changes are reported.

b. A change of address is reported after the processing deadline (cash assistance only). The worker will notify DMS to release the benefit to the new address. In addition, the worker will notify the client via Form 145 that the benefit was mailed to the new address and will request that the client provide verification of the address change and the new living arrangements within ten (10) days. In these cases, it is not necessary to hold the check until verification is received. However the case must be closed for the following month if the client does not provide verification as requested.

2. Procedures for holding checks and Food Stamp benefits

a. DMS will inform local offices of the hold deadline date at the beginning of each month.

b. Requests to hold checks or Food Stamp benefits will be sent to DMS via messages on the DCIS system. Messages are sent after 3:00 p.m. every day listing all benefits to be held that day.

Separate messages are sent for Food Stamp benefits and checks. The messages must include the case name, DCIS ID number, and case suffix of each benefit to be held. In addition, the Zip Code for each check that is held and the complete address for each Food Stamp benefit that is held must be included in the message.

Sample Message Format

From: Pool 460

To: DMS

Please hold the following checks:

1) John Smith 032121 G1 19901

2) Bill Jones 031561 A1 19943

3. DMS will also be notified of the disposition of held benefits via messages on the DCIS system. Messages are sent after 3:00 p.m. every day listing all dispositions made that day. Separate messages are sent for Food Stamp benefits and checks. The case name, DCIS ID number, case suffix, and disposition must be included in the message.

Sample format:

From: Pool 460

To: DMS

Please make the following dispositions on held Food Stamp benefits.

1) Bob Jones 234161 F1 cancel

2) Sheila Brown 191000 Fl mail to current address

3) Susan Green 192013 F1 mail to 22 Black St., Dover, DE 19901

4) If the printer at DMS is not functioning, a message will be sent to all local offices the next day to request that the list of the previous days' holds and dispositions be sent again.

5) DMS will send a list of the checks and Food Stamp benefits still on hold after the first of the month to each local office. Disposition must be made on all benefits by the 15th of the month.

On the 15th of the month DMS will send to the attention of the Operations Administrators a list of benefits still on hold. It is the responsibility of Operations Administrators to ensure that disposition is made on all benefits by the DCIS processing deadline. If disposition is not made, the next month's benefit will also be held.

**History**
- *18 DE Reg. 139 (08/01/14)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *18 DE Reg. 139 (08/01/14)*
- *9 DE Reg. 1368 (03/01/06)*
- *13 DE Reg. 661 (11/01/09)*
- *8 DE Reg. 1153 (2/1/05)*
- *9 DE Reg. 1756 (5/1/06)*
- *9 DE Reg. 1756 (5/1/06)*
- *15 DE Reg. 1025 (01/01/12)*
- *18 DE Reg. 142 (08/01/14)*
- *10 DE Reg. 1007 (12/01/06)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *9 DE Reg. 1370 (03/01/06)*
- *16 DE Reg. 874 (02/01/13)*
- *10 DE Reg. 1441 (03/01/07)*
- *24 DE Reg. 1009 (05/01/21)*
- *7 DE Reg. 647 (11/01/03)*
- *15 DE Reg. 1616 (05/01/12)*
- *21 DE Reg. 722 (03/01/18)*

##### **16 Del. Admin. Code § 2000-2010** Disposition of Benefits Returned in the Mail {#sec-2000-2010 omnilex-key=us-de-regs-official--title-16--2000-2010}

Each month DMS will notify each local office of all benefits that are returned in the mail. Disposition must be made on these benefits by the DCIS processing deadline. DMS will be notified of the dispositions via messages online. Messages are sent each day after 3:00 p.m. listing all dispositions made that day on returned in the mail benefits. Separate messages are sent for checks and food stamps, and will include the disposition, case name, DCIS ID number, case suffix, and address change, if any, of each benefit.

Sample Format:

From: Pool 460

To: DMS

Please make the following dispositions on checks returned in the mail:

1. John Smith 013522 A1 cancel

2. Larry Green 013511 G1 remail to current address

3. John Jones 015311 A1 remail to 13 Smith St., Dover, DE 19901

**History**
- *18 DE Reg. 139 (08/01/14)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *18 DE Reg. 139 (08/01/14)*
- *9 DE Reg. 1368 (03/01/06)*
- *13 DE Reg. 661 (11/01/09)*
- *8 DE Reg. 1153 (2/1/05)*
- *9 DE Reg. 1756 (5/1/06)*
- *9 DE Reg. 1756 (5/1/06)*
- *15 DE Reg. 1025 (01/01/12)*
- *18 DE Reg. 142 (08/01/14)*
- *10 DE Reg. 1007 (12/01/06)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *9 DE Reg. 1370 (03/01/06)*
- *16 DE Reg. 874 (02/01/13)*
- *10 DE Reg. 1441 (03/01/07)*
- *24 DE Reg. 1009 (05/01/21)*
- *7 DE Reg. 647 (11/01/03)*
- *15 DE Reg. 1616 (05/01/12)*
- *21 DE Reg. 722 (03/01/18)*

##### **16 Del. Admin. Code § 2000-2011** Issuing Benefit Restorations {#sec-2000-2011 omnilex-key=us-de-regs-official--title-16--2000-2011}

7 CFR 273.17, 45 CFR 233.20(a)(12)

This policy applies to cash assistance and food benefit applicants and recipients that received less benefits than they were eligible to receive. The need for restoration may be identified by the client or DHSS. Eligibility for restoration may also be determined by a court or administrative hearing decision or a change in law.

1. DSS Must Correct All Under-issuances

An under-issuance occurs when the amount of benefit that the household received was less than the benefit the household was entitled to receive. In these instances DSS will issue a benefit equal to the difference between what was received and what should have been received. This is called a restoration.

Exception: Restorations are not issued when funding is not available.

2. Restorations Must Be Approved

Benefit restorations must be approved by a designated authority. The following are authorized to approve restorations as indicated.

A. Operations Administrator: approves 1 to 3 months of benefits.

B. Chief Administrator: approves 4 to 12 months of benefits.

C. Fair hearing or court decision: required for 13 or more months of benefits.

3. DHSS Applies Restorations to Unpaid Overpayments and Claims

If the client has an unpaid overpayment or claim, the agency will first use the restoration to reduce the overpayment or claim. Any remaining funds are sent to the client. See DSSM 7002.1 and DSSM 9011.1.

4. DHSS Issues Restorations When the Household Composition Changes

Issue benefit restorations even if a household’s membership has changed. In this instance issue the restoration to the household containing a majority of the individuals who were household members at the time the loss occurred. If the agency cannot locate or determine the household which contains a majority of household members, the agency will issue the restoration to the household containing the head of the household at the time the loss occurred.

**History**
- *18 DE Reg. 139 (08/01/14)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *18 DE Reg. 139 (08/01/14)*
- *9 DE Reg. 1368 (03/01/06)*
- *13 DE Reg. 661 (11/01/09)*
- *8 DE Reg. 1153 (2/1/05)*
- *9 DE Reg. 1756 (5/1/06)*
- *9 DE Reg. 1756 (5/1/06)*
- *15 DE Reg. 1025 (01/01/12)*
- *18 DE Reg. 142 (08/01/14)*
- *10 DE Reg. 1007 (12/01/06)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *9 DE Reg. 1370 (03/01/06)*
- *16 DE Reg. 874 (02/01/13)*
- *10 DE Reg. 1441 (03/01/07)*
- *24 DE Reg. 1009 (05/01/21)*
- *7 DE Reg. 647 (11/01/03)*
- *15 DE Reg. 1616 (05/01/12)*
- *21 DE Reg. 722 (03/01/18)*

##### **16 Del. Admin. Code § 2000-2012** Deceased Recipients {#sec-2000-2012 omnilex-key=us-de-regs-official--title-16--2000-2012}

Eligible individuals may receive benefits up to and including the date of his/her death.

For Cash Assistance:

If a recipient dies after midnight of the first day of the month, but before he has received his grant or was unable to endorse and cash it, the check may be returned to the Payments Section, DMS. There it will be marked "Payable to the estate of" the recipient. The name of the person handling the estate will be designated as payee. The check will be sent to the person handling the estate.

For Food Stamps:

If the deceased recipient was the only household member, the food stamp benefits are returned to the agency.

If the deceased recipient is the payee of the benefit for a household, the remaining household members are eligible for the benefit at the same level for the current month, and if eligible due to ten day notice, for the next month’s benefit.

For Medical Assistance:

Individuals may receive benefits up to and including the date of his/her death.

For Long Term Care:

Institutions may receive vendor payment up to and including the date of death.

**History**
- *18 DE Reg. 139 (08/01/14)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *18 DE Reg. 139 (08/01/14)*
- *9 DE Reg. 1368 (03/01/06)*
- *13 DE Reg. 661 (11/01/09)*
- *8 DE Reg. 1153 (2/1/05)*
- *9 DE Reg. 1756 (5/1/06)*
- *9 DE Reg. 1756 (5/1/06)*
- *15 DE Reg. 1025 (01/01/12)*
- *18 DE Reg. 142 (08/01/14)*
- *10 DE Reg. 1007 (12/01/06)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *9 DE Reg. 1370 (03/01/06)*
- *16 DE Reg. 874 (02/01/13)*
- *10 DE Reg. 1441 (03/01/07)*
- *24 DE Reg. 1009 (05/01/21)*
- *7 DE Reg. 647 (11/01/03)*
- *15 DE Reg. 1616 (05/01/12)*
- *21 DE Reg. 722 (03/01/18)*

##### **16 Del. Admin. Code § 2000-2013** Verification {#sec-2000-2013 omnilex-key=us-de-regs-official--title-16--2000-2013}

7 CFR 272.8(a), 7 CFR 273.2(f)(9)

In general all categorical eligibility factors must be verified before assistance can be authorized unless policy specific to that factor indicates that verification can be delayed.

When a redetermination is due, the recipient must complete a new DSS application form (Form 100). A redetermination is complete when all eligibility factors are examined and a decision regarding continuing eligibility is reached.

Close the assistance case of a recipient who fails, without good cause, to complete the redetermination review. Likewise, close the assistance case of a recipient who fails, without good cause, to provide requested information necessary to establish continued eligibility.

As part of the verification process for continuing eligibility, the person will provide verification that s/he has carried out the elements of the individual Contract of Mutual Responsibility. The penalties for non-cooperation in developing the Contract and/or following through with the required components of the Contract are also detailed.

Refer to DSSM 2001 for specific information regarding timeframes for returning verifications and noticing requirements.

Recipients are required to verify changes in circumstance within ten (10) days of the report of the change.

2013.1 Income and Eligibility Verification Systems (IEVS)

The purpose of the Income and Eligibility Verification Systems is to obtain and verify income information relevant to determining eligibility and benefit amounts in the TANF, FS, Child Care, and Medicaid programs through a series of computer matches and on‑ line interfaces. In IEVS, the Division will obtain:

Information obtained through IEVS will enable the Division to:

Except for IRS information, IEVS data is stored in DCIS and can be viewed by accessing the system (see the DCIS User Guide for instructions). IRS information is not stored in DCIS. It is available in hard copy only and is safeguarded according to IRS regulations.

2013.2 IEVS Notification to Applicants and Recipients

Applicants and recipients must be notified that income and eligibility information will be obtained from the IEVS income sources (DOL, SSA, DMV, IRS) and will be used to determine initial and ongoing eligibility for benefits. This notice is part of the DSS application form (Form 100) and is explained to applicants and recipients at the time of application and at each recertification or redetermination of eligibility.

2013.3 Requesting IEVS Information

Information will be requested from the IEVS income sources on all Cash Assistance, FS, and Medicaid applicants and recipients and on other individuals whose income is considered in determining eligibility for these programs. Other individuals include step‑parents, minor parents' parents, and disqualified and sanctioned individuals.

Exception: The Food Supplement Program will not request or utilize unearned income data from the IRS.

Information on persons who apply for benefits is requested from all IEVS income sources each month. For recipients and other individuals, information is requested as indicated below:

2013.4 Using IEVS Information

Applicants - Information obtained through IEVS is used to determine initial eligibility and benefit amounts. However, DSS cannot delay an eligibility determination solely because IEVS data is not available, unless the income information reported by the applicant is questionable. If all other eligibility requirements have been met and IEVS data has not been received, an eligibility decision must be made. When IEVS data becomes available, the information must be acted on in the timeframes allowed for processing IEVS information on recipients.

Recipients ‑ DSS must act on information received through IEVS on active recipients within 30 days of the receipt of that information. This includes:

The 30‑day IEVS processing period begins when IEVS information is received by the State Office. The deadline may be extended in cases where it is necessary to contact a collateral source to verify IEVS data and the source has not responded. However, this deadline can be extended to no more than 20% of the cases involving collateral verification.

DCIS will track the 30‑day IEVS processing period beginning the day information is received from the information source. When information is acted on, the worker will notate the DCIS file with a code indicating that the match information has been resolved. Each month a report will be generated by DCIS that lists the cases for which IEVS information has not been resolved.

Information received on recipients whose benefits have been terminated must also be resolved, but these cases are not subject to the 30‑day processing deadline. If an individual reapplies for benefits, any IEVS information that has not been acted on must be resolved before the application is approved.

2013.5 IEVS Case Processing Instructions

DSS will request information from the IEVS participating information sources by sending a tape listing current DSS applicants and recipients to the sources in the timeframes indicated in DSSM 2013.3. Information available from the sources' files is matched with DSS clients using the clients' Social Security Numbers.

UC data received from DOL and SSI and RSDI information received from SSA is verified. The DCIS file will be automatically updated and benefits will be recalculated using SSI and UC information. In the instance of RSDI data, DSS workers must resolve discrepancies between SSA and State Agency data, as described later in this section.

Wage and other income and resource data obtained through IEVS is not verified. When received, this data will first be processed by DCIS to screen out irrelevant data and data already known to the DCIS system. Any remaining unresolved wage and income data will be forwarded to Audit and Recovery Management Services (ARMS) for resolution.

ARMS resolves the wage and income data affecting the cases and forwards the information to the appropriate DSS supervisor via a transmittal form which informs DSS of what action should take place. If there is no change, the ARMS worker will notate the case record to indicate IEVS data did not necessitate a case change.

If IEVS information received on applicants can be resolved within the 30‑day application processing limit, the application cannot be approved until the IEVS information is documented.

Wage and income information can be resolved by contacting the applicant or recipient or by contacting a reliable third party source (i.e., the employer or the source of other income). It is not necessary to secure the client's permission prior to contacting the third party source because applicants and recipients are notified at application and at redetermination or recertification of DSS' intention to obtain and use IEVS information to establish eligibility.

NOTE: DCIS will use the appropriate reason codes that notify the recipients that the benefit change resulted from information obtained through IEVS. Use of these codes allows DSS to document eligibility and benefit determinations made on the basis of IEVS information.

Additionally, to process IEVS information the procedures outlined below specific to the income information source are followed.

DOL

At application and at recertification or redetermination, DSS screeners will screen each applicant or recipient aged 16 and older through the DOL on‑ line computer interface. Regardless of whether the individual is found in the DOL system, a minimum of one DOL screen will be printed and included in the case file as evidence that the screening was completed.

Wage information in the DOL system is not verified. If wage information in the previous two quarters is discovered, it must be resolved as part of the application or redetermination/ recertification process. UC information is verified and is used to determine eligibility and benefit amounts.

DMV

At application and at redetermination or recertification, DSS screeners will screen applicants and recipients aged 16 and older through the DMV on‑line computer interface when the individual does not report motor vehicle ownership, the situation appears questionable, and further investigation is warranted in order to establish eligibility. Examples of questionable situations include, but are not limited to, persons who do not claim MV ownership and are: 1) employed, or 2) were recently employed, or 3) live in remote locations. Routine DMV screening of all applicants and recipients is not required. DMV vehicle information registration discovered in the system is not verified and must be documented independently as part of the application process.

In addition to vehicle registration information, the address reported to DMV of each person holding a Delaware driver's license is also on file in the system. Though there is no requirement to check this information regularly, workers should be aware that it is available. An example of its potential use is to check the address of an absent parent.

NOTE: If information obtained from the DOL or DMV on‑line interface was not reported by the applicant or recipient and this information is relevant to the eligibility and benefit determination, DCIS will use an IEVS reason code. Use of these codes will enable DSS to document eligibility and benefit determinations made on the basis of obtaining and using IEVS information.

SSA

At application all applicants must furnish a SSN or provide proof that an application for a number has been filed with the Social Security Administration. Applicants who have a number will be asked to provide proof of the number. Acceptable documentation includes a Social Security card, a pay stub, a W‑ 2 form or a UC claim card. If an applicant is unable to provide proof of his/her number but can furnish one, the application will be processed using the number the applicant furnished. All SSN's will be submitted to the SSA for verification through IEVS.

Numbers not verified by IEVS will be forwarded to Audit and Recovery Management Services (ARMS) for resolution. The procedure for handling unverified SSN's appears in DSSM 9032.5. If it is determined by ARMS that an applicant or recipient provided a false SSN in order to receive benefits for which he/she was not entitled, a claim or overpayment will be processed.

ARMS will notify DSS eligibility workers if it is unable to resolve an unverified Social Security Number. It is the responsibility of the eligibility worker to refer the recipient to the Social Security Administration to reapply for a Social Security Number. When this referral is made, the eligibility worker will note on the referral form (Form 122) the individual's unverified number so it can be investigated. These persons can continue to receive benefits as long as they provide proof that an application for a SSN has been filed at the Social Security Administration within ten (10) days of the referral.

At application, the intake worker will request verification of SSI and RSDI benefits listed on the application. Acceptable verification includes the recipient's award letter that verifies the current benefit or a response from the Third Party Query System (TPQY). If information on benefits has not been verified by the 30th day following the date the application was filed, determine eligibility using the applicant's statement regarding the SSI or RSDI amount. BENDEX information is used on a monthly basis to determine program benefits. DCIS produces a monthly report indicating the RSDI benefit amount shown on the BENDEX report from SSA as well as the RSDI amount currently displayed on the DCIS file for each RSDI recipient. When both amounts agree, no further action is necessary. Whenever there is a discrepancy between the two RSDI amounts shown, proceed as follows:

1. Investigate the discrepancy and attempt to determine which figure is accurate. SSA's Third Party Query System (TPQY) report and award letters should be useful resources.

2. If the discrepancy is resolved, notify the Information Systems Unit (ISU) DCIS, Biggs Building, Herman M. Holloway, Sr. Health and Social Services Campus, and provide them with copies of any documentation used in your investigation.

3. Make any necessary corrections to DCIS.

4. If the BENDEX data appears discrepant, notify ISU of the circumstances so that technical assistance from SSA can be sought.

IRS

DSS matches its active file with IRS files annually. Newly accredited cases are submitted for matching on a monthly basis. Unearned income sources revealed through this match process are considered unverified until independent third party documentation is obtained through either the household or appropriate income, resource or benefit source.

ARMS has exclusive access to the IRS match reports, which are maintained in accordance with IRS (Dept. of the Treasury) Publication 1075, as well as the DHSS IEVS Security Action Plan developed by ARMS. IRS information is not placed in casefiles. Every effort is made to protect the confidentiality of the information and prevent its unauthorized use.

2013.6 Child Support Interface

Also included in DCIS, but not part of IEVS, is a computer interface with the Division of Child Support Enforcement.

In this system information regarding child support payments collected on behalf of TANF recipients and child support payments dispersed to recipients as bonus checks is entered into DCIS and automatically updates the DCIS data base. This is accomplished via computer interface with DCSE's computer system.

Each month the DCSE/DSS interface lists the amount of child support collected on behalf of children receiving TANF in the previous month. The DCIS data base is automatically updated with this information and the DCIS grant calculator uses the child support amount to determine the TANF unit's continuing financial eligibility. The TANF case is closed if existing income plus the countable child support payment exceed the TANF standard.

A second interface occurs with DCSE each month. The interfaces indicate when child support disregard/pass-through checks were issued and provides the basis for the TANF child support supplemental check computation. This information is matched with the related Food Stamp case to re‑calculate Food Stamp benefits for the following month.

**History**
- *18 DE Reg. 139 (08/01/14)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *18 DE Reg. 139 (08/01/14)*
- *9 DE Reg. 1368 (03/01/06)*
- *13 DE Reg. 661 (11/01/09)*
- *8 DE Reg. 1153 (2/1/05)*
- *9 DE Reg. 1756 (5/1/06)*
- *9 DE Reg. 1756 (5/1/06)*
- *15 DE Reg. 1025 (01/01/12)*
- *18 DE Reg. 142 (08/01/14)*
- *10 DE Reg. 1007 (12/01/06)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *9 DE Reg. 1370 (03/01/06)*
- *16 DE Reg. 874 (02/01/13)*
- *10 DE Reg. 1441 (03/01/07)*
- *24 DE Reg. 1009 (05/01/21)*
- *7 DE Reg. 647 (11/01/03)*
- *15 DE Reg. 1616 (05/01/12)*
- *21 DE Reg. 722 (03/01/18)*

##### **16 Del. Admin. Code § 2000-2014** Budgeting Procedures for TANF, GA, RCA and Food Stamps {#sec-2000-2014 omnilex-key=us-de-regs-official--title-16--2000-2014}

2014.1 Definitions

The following definitions are applicable to this section:

1. Prospective budgeting means to determine eligibility or to compute the benefit level for a payment/issuance month based on the Division's best estimate of income and circumstances which will exist in that month. The worker will base the estimate on the Division's reasonable expectation and knowledge of current, past, or future circumstances verified through the employer, recent pay stubs, award letters, the applicant or other income source.

2. Budget month means the calendar month for which the Division uses income or circumstances to compute the amount of the benefit.

NOTE: In prospective budgeting, the budget month and the payment/issuance month are the same.

3. Payment/issuance month means the calendar month for which benefits are paid.

4. Beginning/initial month means those months at initial application in which benefits may be calculated differently than on-going months.

A month in which an applicant household is determined eligible and would have received a benefit except for the $10 restriction will be a benefit considered as an initial month.

A month in which an applicant household is ineligible for the month of application, but eligible for the following month, will not be counted as an initial month for food stamps or TANF/GA.

2014.2 Eligibility Determination

Eligibility is always determined prospectively.

All cases are determined prospectively for the initial month of application and the subsequent months.

When adding new members to an on-going case, the new members and their income and resources are added prospectively.

2014.3 Method for Calculating Prospective Best Estimate

Obtain all available information from the client and possible income sources to estimate the income. Use all income received in the previous thirty (30) days to determine the future income. If the past income is not an indicator of future income, verify the amount of the expected income from the income source.

When income is received on a weekly, bi-weekly, or semi-monthly basis, convert the income to the monthly amount by multiplying by the appropriate income conversion factor as follows:

Weekly - 4.33

Bi-weekly - 2.16

Semi-monthly - 2

Example 1: Client is employed by TANF company and works 15 to 20 hours per week. He earns $5.00 an hour and is paid bi-weekly. His last four weeks average 17.5 hours per week.

The bi-weekly hours average of 35 hours is multiplied by $5.00 an hour to get the estimate of $175.00 per pay. Multiply the $175.00 bi-weekly pay by 2.16 to get the estimated monthly gross total income of $378.00.

Example 2: Client is employed 40 hours per week by XYZ Designs. The last four weeks indicated she made $6.00 an hour. The weekly gross income of $240.00 is multiplied by 4.33 to get an estimated monthly gross income of $1039.20.

Client reports that her hours were reduced in half effective the week she applied for benefits. After verifying the reduction with the employer, 20 hours weekly multiplied by $6.00 is $120.00. The monthly gross income of $519.60 is the weekly income of $120.00 multiplied by the weekly conversion factor of 4.33.

Changes in income are budgeted prospectively after verifying the information. Changes include, but are not limited to, changes in hourly rates, new jobs, changes from part to full time status (or vice versa), or loss of jobs. Do not budget prospectively changes in income due solely to things such as an extra pay cycle, bonus pay, and overtime or holiday pay.

2014.4 Grant Computation

[273.21(f)]

Once eligibility has been established, benefits are computed prospectively for the initial month and the following month.

1. Income received by individuals paid on a contractual basis (e.g., school teachers), farmers, and self‑employed individuals is averaged. Income covered under a contract must be averaged over the number of months covered by the contract. Intermittent income received quarterly, semi‑annually, or yearly such as farm income, will be averaged over the period covered by the income if it is reasonably expected to continue in the future. Income from educational grants, scholarships, or deferred educational loans are pro-rated over the period they are intended to cover. The averaged or pro-rated amount is recalculated when the base used to calculate the monthly amount changes. Recalculation could be occasioned by the signing of a new contract or the beginning of a new school term.

2. When an eligible individual is added to an existing TANF/GA unit, the eligible individual's needs will be reflected in the assistance at the time his/her eligibility is determined and a supplemental grant will be issued.

When a FS household reports that it has gained a new member (including newborns), the member is added effective the month the household reports the gain of the new member. A supplement will be issued for the entire month the new member is reported and added to the household. The additional benefits will not be prorated.

EXAMPLE: Household reports the birth of a baby on March 20. The baby is added to the case effective March 1 and a full supplement is issued.

Household reports the addition of two nephews on May 28. The two individuals are added to the household effective May 1 and a full supplement is issued.

The new member's income is budgeted prospectively. If the new member had been providing income to the household on an ongoing basis prior to becoming a member of the household, the previously provided income will be excluded in determining the household's benefits for the issuance month the new member is added.

EXAMPLE: Father moves back into the household on November 1. He had been sending child support payments to the household. Father is added to the household effective November 1. His income is budgeted prospectively for November on. No child support is budgeted.

Excluded household members whose income has been deemed as available to the household are added prospectively. Individuals previously disqualified for an intentional Program violation or failure to comply with work requirements must be added the month after their disqualification periods ends.

The following household members must be added using prospective budgeting procedures:

Others (e.g. students) must be added using the budgeting procedures for adding new members who were not previously living with the household.

If an individual has moved out of one participating FS household within the State and moves into another with no break in participation, the individual's income, deductible expenses, and resources from the budget month are used in determining benefits to be provided in the issuance month. The individual, his income and resources, and his deductible expenses, are included in determining the issuance month eligibility and benefit level of either the household from which the individual has moved or the household into which the individual has moved, but not both.

If an individual moves out of a participating FS household and is no longer a Program participant, the individual and his income and resources are excluded when determining the household's FS allotment.

3. Deductions for eligible FS households are allowable as billed or averaged from the corresponding budget month. Included are those shelter costs billed less often than monthly which the household has chosen to average.

For households opting to average expenses, use the average amount determined unless a reported rate increase or first time expense necessitates are‑ calculation.

4. When a Food Stamp only recipient applies for cash assistance, the cash assistance benefit is determined prospectively.

**History**
- *18 DE Reg. 139 (08/01/14)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *18 DE Reg. 139 (08/01/14)*
- *9 DE Reg. 1368 (03/01/06)*
- *13 DE Reg. 661 (11/01/09)*
- *8 DE Reg. 1153 (2/1/05)*
- *9 DE Reg. 1756 (5/1/06)*
- *9 DE Reg. 1756 (5/1/06)*
- *15 DE Reg. 1025 (01/01/12)*
- *18 DE Reg. 142 (08/01/14)*
- *10 DE Reg. 1007 (12/01/06)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *9 DE Reg. 1370 (03/01/06)*
- *16 DE Reg. 874 (02/01/13)*
- *10 DE Reg. 1441 (03/01/07)*
- *24 DE Reg. 1009 (05/01/21)*
- *7 DE Reg. 647 (11/01/03)*
- *15 DE Reg. 1616 (05/01/12)*
- *21 DE Reg. 722 (03/01/18)*

##### **16 Del. Admin. Code § 2000-2015** Medical Assistance Eligibility for Cash Assistance Recipients {#sec-2000-2015 omnilex-key=us-de-regs-official--title-16--2000-2015}

Please refer to the following sections of the Division of Social Services Manual:

13000 Medical Assistance Program Overview,

14000 Common Eligibility,

15000 Family and Community Eligibility, and

16000 Federal Poverty Level Related programs.

**History**
- *18 DE Reg. 139 (08/01/14)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *18 DE Reg. 139 (08/01/14)*
- *9 DE Reg. 1368 (03/01/06)*
- *13 DE Reg. 661 (11/01/09)*
- *8 DE Reg. 1153 (2/1/05)*
- *9 DE Reg. 1756 (5/1/06)*
- *9 DE Reg. 1756 (5/1/06)*
- *15 DE Reg. 1025 (01/01/12)*
- *18 DE Reg. 142 (08/01/14)*
- *10 DE Reg. 1007 (12/01/06)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *9 DE Reg. 1370 (03/01/06)*
- *16 DE Reg. 874 (02/01/13)*
- *10 DE Reg. 1441 (03/01/07)*
- *24 DE Reg. 1009 (05/01/21)*
- *7 DE Reg. 647 (11/01/03)*
- *15 DE Reg. 1616 (05/01/12)*
- *21 DE Reg. 722 (03/01/18)*

##### **16 Del. Admin. Code § 2000-2016** Reserved {#sec-2000-2016 omnilex-key=us-de-regs-official--title-16--2000-2016}

**History**
- *18 DE Reg. 139 (08/01/14)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *18 DE Reg. 139 (08/01/14)*
- *9 DE Reg. 1368 (03/01/06)*
- *13 DE Reg. 661 (11/01/09)*
- *8 DE Reg. 1153 (2/1/05)*
- *9 DE Reg. 1756 (5/1/06)*
- *9 DE Reg. 1756 (5/1/06)*
- *15 DE Reg. 1025 (01/01/12)*
- *18 DE Reg. 142 (08/01/14)*
- *10 DE Reg. 1007 (12/01/06)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *9 DE Reg. 1370 (03/01/06)*
- *16 DE Reg. 874 (02/01/13)*
- *10 DE Reg. 1441 (03/01/07)*
- *24 DE Reg. 1009 (05/01/21)*
- *7 DE Reg. 647 (11/01/03)*
- *15 DE Reg. 1616 (05/01/12)*
- *21 DE Reg. 722 (03/01/18)*

##### **16 Del. Admin. Code § 2000-2017** Reserved {#sec-2000-2017 omnilex-key=us-de-regs-official--title-16--2000-2017}

**History**
- *18 DE Reg. 139 (08/01/14)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *18 DE Reg. 139 (08/01/14)*
- *9 DE Reg. 1368 (03/01/06)*
- *13 DE Reg. 661 (11/01/09)*
- *8 DE Reg. 1153 (2/1/05)*
- *9 DE Reg. 1756 (5/1/06)*
- *9 DE Reg. 1756 (5/1/06)*
- *15 DE Reg. 1025 (01/01/12)*
- *18 DE Reg. 142 (08/01/14)*
- *10 DE Reg. 1007 (12/01/06)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *9 DE Reg. 1370 (03/01/06)*
- *16 DE Reg. 874 (02/01/13)*
- *10 DE Reg. 1441 (03/01/07)*
- *24 DE Reg. 1009 (05/01/21)*
- *7 DE Reg. 647 (11/01/03)*
- *15 DE Reg. 1616 (05/01/12)*
- *21 DE Reg. 722 (03/01/18)*

##### **16 Del. Admin. Code § 2000-2018** Reserved {#sec-2000-2018 omnilex-key=us-de-regs-official--title-16--2000-2018}

**History**
- *18 DE Reg. 139 (08/01/14)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *18 DE Reg. 139 (08/01/14)*
- *9 DE Reg. 1368 (03/01/06)*
- *13 DE Reg. 661 (11/01/09)*
- *8 DE Reg. 1153 (2/1/05)*
- *9 DE Reg. 1756 (5/1/06)*
- *9 DE Reg. 1756 (5/1/06)*
- *15 DE Reg. 1025 (01/01/12)*
- *18 DE Reg. 142 (08/01/14)*
- *10 DE Reg. 1007 (12/01/06)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *9 DE Reg. 1370 (03/01/06)*
- *16 DE Reg. 874 (02/01/13)*
- *10 DE Reg. 1441 (03/01/07)*
- *24 DE Reg. 1009 (05/01/21)*
- *7 DE Reg. 647 (11/01/03)*
- *15 DE Reg. 1616 (05/01/12)*
- *21 DE Reg. 722 (03/01/18)*

##### **16 Del. Admin. Code § 2000-2019** Reserved {#sec-2000-2019 omnilex-key=us-de-regs-official--title-16--2000-2019}

**History**
- *18 DE Reg. 139 (08/01/14)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *18 DE Reg. 139 (08/01/14)*
- *9 DE Reg. 1368 (03/01/06)*
- *13 DE Reg. 661 (11/01/09)*
- *8 DE Reg. 1153 (2/1/05)*
- *9 DE Reg. 1756 (5/1/06)*
- *9 DE Reg. 1756 (5/1/06)*
- *15 DE Reg. 1025 (01/01/12)*
- *18 DE Reg. 142 (08/01/14)*
- *10 DE Reg. 1007 (12/01/06)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *9 DE Reg. 1370 (03/01/06)*
- *16 DE Reg. 874 (02/01/13)*
- *10 DE Reg. 1441 (03/01/07)*
- *24 DE Reg. 1009 (05/01/21)*
- *7 DE Reg. 647 (11/01/03)*
- *15 DE Reg. 1616 (05/01/12)*
- *21 DE Reg. 722 (03/01/18)*

##### **16 Del. Admin. Code § 2000-2020** Burial Assistance {#sec-2000-2020 omnilex-key=us-de-regs-official--title-16--2000-2020}

A person who is receiving TANF, GA, or Medicaid at the time of death or a minor child of such a person who would have been eligible for TANF, GA, and Medicaid at the time of death is entitled to assistance for burial expenses from the State. The amount paid toward these expenses cannot exceed $100. The deceased individual's next of kin must request burial assistance from DSS in writing and provide proof of burial expenses. Upon receipt of a request for burial assistance, the DSS worker will complete Form 112 according to the instructions in the Forms Index Manual. The completed Form 112 is to be mailed to:

Division of Management Services

Business Office

Herman Holloway Sr. DHSS Campus

1901 N. DuPont Highway - Main Building

New Castle, DE 19720

**History**
- *18 DE Reg. 139 (08/01/14)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *18 DE Reg. 139 (08/01/14)*
- *9 DE Reg. 1368 (03/01/06)*
- *13 DE Reg. 661 (11/01/09)*
- *8 DE Reg. 1153 (2/1/05)*
- *9 DE Reg. 1756 (5/1/06)*
- *9 DE Reg. 1756 (5/1/06)*
- *15 DE Reg. 1025 (01/01/12)*
- *18 DE Reg. 142 (08/01/14)*
- *10 DE Reg. 1007 (12/01/06)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *9 DE Reg. 1370 (03/01/06)*
- *16 DE Reg. 874 (02/01/13)*
- *10 DE Reg. 1441 (03/01/07)*
- *24 DE Reg. 1009 (05/01/21)*
- *7 DE Reg. 647 (11/01/03)*
- *15 DE Reg. 1616 (05/01/12)*
- *21 DE Reg. 722 (03/01/18)*

##### **16 Del. Admin. Code § 2000-2021** Coordination With Audit and Recovery Management Services (ARMS) {#sec-2000-2021 omnilex-key=us-de-regs-official--title-16--2000-2021}

Audit and Recovery Management Services (ARMS), in its investigatory role, has authority to close DSS cases. ARMS, however, cannot entertain reapplications which must be handled through the DSS intake structure.

Recipients inquiring regarding termination of assistance generally reach the ARMS investigator whose name appeared on the DCIS‑generated notice of advance action announcing the termination. ARMS will refer clients back to their DSS workers in accordance with the following procedure:

**History**
- *18 DE Reg. 139 (08/01/14)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *18 DE Reg. 139 (08/01/14)*
- *9 DE Reg. 1368 (03/01/06)*
- *13 DE Reg. 661 (11/01/09)*
- *8 DE Reg. 1153 (2/1/05)*
- *9 DE Reg. 1756 (5/1/06)*
- *9 DE Reg. 1756 (5/1/06)*
- *15 DE Reg. 1025 (01/01/12)*
- *18 DE Reg. 142 (08/01/14)*
- *10 DE Reg. 1007 (12/01/06)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *9 DE Reg. 1370 (03/01/06)*
- *16 DE Reg. 874 (02/01/13)*
- *10 DE Reg. 1441 (03/01/07)*
- *24 DE Reg. 1009 (05/01/21)*
- *7 DE Reg. 647 (11/01/03)*
- *15 DE Reg. 1616 (05/01/12)*
- *21 DE Reg. 722 (03/01/18)*

##### **16 Del. Admin. Code § 2000-2022** Identification Cards {#sec-2000-2022 omnilex-key=us-de-regs-official--title-16--2000-2022}

2022.1 General Information

Issue a serially numbered photo-ID card to each approved Cash Assistance payee as proof of program eligibility.

Issue the ID card in the name of the household/assistance unit member to whom the check is issued. The participant/recipient and any authorized representative will sign the card in ink and it will be laminated in the DSS office.

For Voluntary Protective payees in TANF, GA, or RCA, issue the protective payee an ID card with his/her picture on the front of the ID card. The DCIS number of the case for whom he/she is the protective payee, will also be on the front of the ID card.

Limit issuance of ID cards to the time of initial certification with replacement made only in instances of loss, mutilation, destruction, changes in authorized representative, or when DSS determines that new ID cards are needed. Whenever possible, collect the ID card that is being replaced, and any other old ID cards that are in the client's possession.

Do not issue cards having typographical errors or other defects. Banks will not honor ID cards with characters whited out or strikeovers, and will confiscate these cards.

Use cameras for official purposes only. Destroy any pictures taken to test a camera.

Store cameras in a location which ensures that no unauthorized person can have access to them.

At no time may an ID photo be taken when an individual is wearing sunglasses.

Issue temporary (non-photo, unlaminated) ID cards when camera equipment/supplies are unavailable or inoperable. Using the usual ID card, limit use by indicating:

"valid for _______________________only."

(current month/year)

Do not use letters of identification as they are not serially numbered and compromise the bank's mandated record keeping processes.

2022.2 Internal procedures for ID card issuance

The following are procedures to be followed uniformly in each DSS office:

1. Supervisors or their designee can obtain ID cards from the Program Implementation Unit as needed. If cards cannot be picked up personally, make arrangements for delivery by way of other responsible DSS staff members. Never transfer ID cards through messenger mail service. The PIU staff member dispensing the ID cards will obtain the signature of the receiving local office representative on the master log attesting that the cards have been inspected and are all present.

2. Supervisors are responsible for securing ID cards at all times. Protect the card supply by a lock. Protect the working inventory while in use.

3. The Pool supervisor will designate one primary person and one backup person to take pictures and issue ID cards to clients. To assure a secure process, limit the responsibility for general handling/issuing of ID cards to as few staff persons as possible.

4. Each supervisor will maintain a record of ID card numbers released to the working inventory.

5. The staff member requesting an ID card for a client must complete an ID card request, in writing, and forward it to the person issuing the ID card.

6. Each location must maintain a log, pre-numbered to correspond with the serial numbers on the ID cards. As cards are issued, the staff member dispensing the card must record on the log the name and DCIS # of the client and the date of issue. The staff member's initials must also appear on the log. Cards voided during the issuance process will be notated by the appropriate number on the log sheet. Punch a hole in any photo(s) and staple the voided card to the log sheet.

7. At the end of the working day, the supervisor (or designee) will assure that the log, and all cards, including voided cards, are returned to the secured storage location. The supervisor (or designee) will review the day's log to assure that every card is accounted for.

8. Any ID cards not accounted for must be reported immediately to Audit and Recovery Management Services (ARMS). Report verbally as soon as the discrepancy is noticed. Submit a Form 714 in writing within two working days.

9. At the end of each month, the supervisor will review the log to assure that every card is accounted for and that all voided cards are attached. The supervisor will reconcile the log by selecting a 10% sample of cards issued during the month. He/she will check the corresponding case records, making sure that the ID card stub has been filed in the front of each record. The supervisor will document the reconciliation by placing his/her initials in the comments section of the log for each card reconciled. Supervisors in offices with more than one unit will share responsibility for this task.

10. On the tenth working day of each month, forward to the Operations Administrator all completed log pages with voided cards attached, for storage. Retain these documents for three years and then discard.

11. The pre-numbered stub attached to the ID card and the written request will be affixed to the front cover of the casefile. Each stub will bear the client's signature and photo, and the photo of any authorized representative.

12. Whenever possible, recover ID cards from clients who are no longer eligible. For example, if a client appears in person to notify you to close a case, request that the client relinquish the card to you. Deface recovered cards by cutting them into at least four pieces, making sure that the photo is cut through. Discard the defaced cards.

2022.3 Do not delay replacement ID cards to eligible participants.

Exercise prudence when issuing replacements due to loss by discussing the possibility of recovery. Request any identification from the client that will assure the identity of the person requesting the card. Discuss suspected cases of misuse of ID cards with your supervisor. The supervisor will report any suspicious client or circumstances to ARMS as soon as possible.

Observe the following procedures prior to issuing a duplicate card:

1. Question client regarding circumstances surrounding need for replacement. If a new ID card is required due to a name change, appropriate legal documents (e.g., marriage license) will be required. Client must surrender obsolete card if in his/her possession.

2. Use the following procedures to verify the client's identity and current eligibility status:

A. Request photo ID from the client such as a driver's license, DMV ID, or military ID. Use the photo to identify the client. If the photo is inconclusive, ask for his/her signature and compare this to the ID signature. As for his/her SSN and use this to obtain his/her DCIS number and eligibility status

B. If the client has no ID, obtain his/her signature, pull the case record and compare the signature and photo in the record to identify the client. Use the case record to obtain the client's DCIS number and eligibility status. Reception staff who are trying to establish identity may request that the worker pull the case record and make the comparisons.

C. If the client has no ID, and the case record cannot be pulled, use the DCIS system to establish identity. Ask the client for his/her SSN. Locate the client in DCIS and ask questions such as birthdate, current/previous address, names and birthdates of children, worker name. Obtain DCIS number and eligibility status. Refer the client to the worker if not satisfied with identification.

3. Have the client sign a dated acknowledgement receipt form (card stub), to be attached to the front cover of the case record.

4. Annotate the ID card log to record the issuance of the duplicate card.

5. Instruct the client to return the original ID card to DSS if located.

**History**
- *18 DE Reg. 139 (08/01/14)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *18 DE Reg. 139 (08/01/14)*
- *9 DE Reg. 1368 (03/01/06)*
- *13 DE Reg. 661 (11/01/09)*
- *8 DE Reg. 1153 (2/1/05)*
- *9 DE Reg. 1756 (5/1/06)*
- *9 DE Reg. 1756 (5/1/06)*
- *15 DE Reg. 1025 (01/01/12)*
- *18 DE Reg. 142 (08/01/14)*
- *10 DE Reg. 1007 (12/01/06)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *9 DE Reg. 1370 (03/01/06)*
- *16 DE Reg. 874 (02/01/13)*
- *10 DE Reg. 1441 (03/01/07)*
- *24 DE Reg. 1009 (05/01/21)*
- *7 DE Reg. 647 (11/01/03)*
- *15 DE Reg. 1616 (05/01/12)*
- *21 DE Reg. 722 (03/01/18)*

##### **16 Del. Admin. Code § 2000-2023** Disqualification for Intentional Program Violation for Food Stamps and TANF {#sec-2000-2023 omnilex-key=us-de-regs-official--title-16--2000-2023}

2023.1 Administrative Responsibility

DSS is responsible for investigating any case of alleged intentional Program violation, and ensuring that appropriate cases are acted upon through administrative disqualification hearings or referral to a court of appropriate jurisdiction.

Administrative disqualification procedures or referral for prosecution actions should be initiated by DSS in cases where DSS has sufficient documentary evidence to substantiate that an individual has intentionally made one or more acts of intentional Program violation as defined in DSSM 2023.3.

Cases to be handled by a DSS administrative hearing:

1. Duplicate Food Stamp benefits and TANF checks.

2. Cases where the claim is less than $1,500 unless the claim is a combination of both program overpayments and is referred for prosecution.

If DSS does not initiate administrative disqualification procedures or refer for prosecution a case involving an overissuance caused by a suspected act of intentional Program violation, take action to collect the overissuance by establishing an inadvertent household error claim against the household in accordance with the procedures in DSSM 7000. DSS should conduct administrative disqualification hearings in cases in which the Division believes the facts of the individual case do not warrant civil or criminal prosecution through the appropriate court system, in cases previously referred for prosecution that were declined by the appropriate legal authority, and in previously referred cases where no action was taken within a reasonable period of time and the referral was formally withdrawn by DSS. Do not initiate an administrative disqualification hearing against an accused individual whose case is currently being referred for prosecution or subsequent to any action taken against the accused individual by the prosecutor or court of appropriate jurisdiction, if the factual issues of the case arise out of the same, or related, circumstances. Initiate administrative disqualification procedures or refer a case for prosecution regardless of the current eligibility of the individual.

Base administrative disqualifications for intentional Program violations on the determinations of hearing authorities arrived at through administrative disqualification hearings in accordance with this section.

2023.2 Disqualification Penalties

Individuals found to have committed intentional Program violation either through an administrative disqualification hearing or by a court of appropriate jurisdiction, or who have signed either a waiver of right to an administrative hearing or a disqualification consent agreement in cases referred for prosecution, will be ineligible to participate in the Program for:

1. A period of one year (12 months) for the first violation;

2. A period of two years (24 months) for the second violation; or for the first time found guilty of selling and purchasing controlled substances with food stamps;

3. Permanently for the third violation; or for the second time found guilty of selling and purchasing controlled substances with food stamps; or for the first time found guilty of selling and purchasing firearms, ammunition or explosives with food stamps, or for the first time convicted of trafficking in Food Stamp benefits valued at $500 or more.

One or more intentional Program violation disqualifications which occurred prior to the implementation of these penalties will be considered as only one previous disqualification when determining the appropriate penalty to impose in a case under consideration.

If a court fails to impose a disqualification period for the intentional Program violation, impose the disqualification penalties specified in this Section unless it is contrary to the court order. Disqualify only the individual found to have committed intentional Program violation and not the entire household. The remaining household members shall agree to make restitution within 10 days of the date the written demand letter is mailed or the household's monthly allotment will be reduced. If the remaining household members agree to make restitution, but fail to do so, impose an allotment reduction on the household's monthly allotment. The remaining household members, if any, will begin restitution during the period of disqualification imposed by DSS or a court of law. All restitutions will be made in accordance with established procedures for cash repayment, allotment reduction, or EBT benefits for repayment.

2023.3 Definition of Intentional Program Violation

For purposes of determining through administrative disqualification hearings whether or not a person has committed an intentional Program violation, intentional Program violations will consist of having intentionally:

1. Made a false or misleading statement, or misrepresented, concealed, or withheld facts, or

2. Committed any act that constitutes a violation of the Food Stamp Act, the TANF/Food Stamp Program Regulations, or any State statute relating to the use, presentation, transfer, acquisition, receipt, or possession of food stamp benefits, or checks.

If the condition in items 1 or 2 are met and the claim meets the criteria for referral to the Department of Justice as set forth in DSSM 7003, it will be referred for prosecution in lieu of an administrative disqualification hearing.

2023.4 Notification to Applicant Households

Inform the household in writing of the disqualification penalties for intentional Program violation each time it applies for Program benefits.

2023.5 Disqualification Hearings

Conduct administrative disqualification hearings for individuals accused of intentional Program violation in accordance with the requirements outlined in this Section.

1. Consolidation of administrative disqualification hearing with fair hearing.

DSS may combine a fair hearing and an administrative disqualification hearing into a single hearing if the factual issues arise out of the same, or related, circumstances and the household receives prior notice that hearings will be combined. If the disqualification hearing and the fair hearing are combined, follow the timeframes for conducting disqualification hearings. If the hearings are combined for the purpose of settling the amount of the claim at the same time as determining whether or not intentional Program violation has occurred, the household will lose its right to a subsequent fair hearing on the amount of the claim. However, upon household request, allow the household to waive the 30‑day advance notice period required by this Section when the disqualification hearing and fair hearing are combined.

2. Disqualification hearing procedures

At the disqualification hearing, the hearing official will advise the household member or representative that they may refuse to answer questions during the hearing.

Within 90 days of the date the household member is notified in writing that a hearing initiated by DSS has been scheduled, DSS will conduct the hearing, arrive at a decision, and notify the household member of the decision. The household member or representative is entitled to a postponement of the scheduled hearing, provided that the request for postponement is made at least 10 days in advance of the date of the scheduled hearing. However, the hearing will not be postponed for more than a total of 30 days and DSS may limit the number of postponements to one. If the hearing is postponed, the above time limits will be extended for as many days as the hearing is postponed. Written rules of procedure for DSS disqualification hearings are available to interested parties.

3. Advance notice of hearing.

Provide written notice to the household member suspected of intentional Program violation at least 30 days in advance of the date a disqualification hearing initiated by DSS has been scheduled. The notice will be mailed certified mail‑ return receipt requested and will contain at a minimum:

a. The date, time, and place of the hearing;

b. The charge(s) against the household member;

c. A summary of the evidence, and how and where the evidence can be examined;

d. A warning that the decision will be based solely on information provided by the DSS office if the household member fails to appear at the hearing;

e. A statement that the household member or representative will have 10 days from the date of the scheduled hearing to present good cause for failure to appear in order to receive a new hearing;

f. A warning that a determination of intentional Program violation will result in a 12-month disqualification for the first violation, 24-month disqualification for the second violation, and permanent disqualification for the third violation, and a statement of which penalty the Division believes is applicable to the case scheduled for a hearing;

g. A listing of the household member's rights as contained in DSSM 5000;

h. A statement that the hearing does not preclude the State or Federal Government from prosecuting the household member for intentional Program violation in a civil or criminal court action, or from collecting the overissuances; and

i. If there is an individual or organization available that provides free legal representation, the notice will advise the household member of the availability of the service.

A copy of DSS' published hearing procedures will be attached to the 30‑day advance notice or the advance notice will inform the household of its right to obtain a copy of the Division's published hearing procedures upon request.

4. Scheduling of hearing.

The time and place of the hearing will be arranged so that the hearing is accessible to the household member suspected of intentional Program violation. If the household member or its representative cannot be located or fails to appear at a hearing initiated by DSS without good cause, the hearing will be conducted without the household member being represented. Even though the household member is not represented, the hearing official is required to carefully consider the evidence and determine if intentional Program violation was committed based on clear and convincing evidence. If the household member is found to have committed an intentional Program violation, but a hearing official later determines that the household member or representative had good cause for not appearing, the previous decision will no longer remain valid and the Division will conduct a new hearing. The hearing official who originally ruled on the case may conduct the new hearing. The household member has 10 days from the date of the scheduled hearing to present reasons indicating a good cause for failure to appear. A hearing official must enter the good cause decision into the record.

5. Participation while awaiting a hearing.

A pending disqualification hearing will not affect the individual's or the household's right to be certified and participate in the Program. Since the Division cannot disqualify a household member for intentional Program violation until the hearing official finds that the individual has committed an intentional Program violation, determine the eligibility and benefit level of the household in the same manner it would be determined for any other household. For example, if the misstatement or action for which household member is suspected of intentional Program violation does not affect the household's current circumstances, the household would continue to receive its benefits based on the latest certification action or be recertified/redetermined based on a new application and its current circumstance. However, the household's benefits will be terminated if the certification period has expired and the household, after receiving its notice of expiration, fails to reapply. Reduce or terminate the household's benefits if DSS has documentation which substantiates that the household is ineligible or eligible for fewer benefits (even if these facts led to the suspicion of intentional Program violation and the resulting disqualification hearing) and the household fails to request a fair hearing and continuation of benefits pending the hearing. For example, the Division may have facts which substantiate that a household failed to report a change in its circumstances even though DSS has not yet demonstrated that the failure to report involved an intentional act of Program violation.

6. Criteria for determining intentional Program violation.

The hearing authority will base the determination of intentional Program violation on clear and convincing evidence which demonstrates that the household member(s) committed, or intended to commit, intentional Program violation as defined in DSSM 2023.3

7. Decision format.

The hearing authority's decision will specify the reasons for the decision, identify the supporting evidence, identify the pertinent FNS/ACF regulation, and respond to reasoned arguments made by the household member or representative.

8. Imposition of disqualification penalties.

If the hearing authority rules that the household member has committed intentional Program violation, the household member will be disqualified in accordance with the disqualification periods specified in DSSM 2023.2 beginning with the first month which follows the date the household member receives written notification of the hearing decision. When the Chief Administrator is notified of the positive administrative hearing or prosecution actions, the Chief Administrator will notify the appropriate staff.

Effect the disqualification action per DSSM 2023 and 9076.1. Remove the ineligible member(s). Continue to count the member's income and resources to determine eligibility and benefit amount.

Individual members no longer receiving benefits at the time of the intentional program violation decision will be notified of the disqualification and the period of time they are ineligible to receive benefits.

Place the copy of the client notice inside the front cover of the case record to "flag" the disqualified participant for the duration of the sanction.

However, if the act of intentional Program violation which led to the disqualification occurred prior to notification of the disqualification periods specified in DSSM 2024.2, the household member will be disqualified in accordance with the disqualification periods in effect at the time of the offense. The same act of intentional Program violation repeated over a period of time will not be separated so that separate penalties can be imposed. No further administrative appeal procedure exists after an adverse State level hearing. The determination of intentional Program violation made by a disqualification hearing official cannot be reversed by a subsequent fair hearing decision. The household member, however, is entitled to seek relief in a court having appropriate jurisdiction. The period of disqualification may be subject to stay by a court of appropriate jurisdiction or other injunctive remedy.

Once a disqualification penalty has been imposed against an individual the period of disqualification will continue uninterrupted until completed regardless of the eligibility of the disqualified member's household. However, the disqualified member's household will continue to be responsible for repayment of the overissuance which resulted from the disqualified member's intentional Program violation regardless of its eligibility for Program benefits.

9. Notification of hearing decision.

If the hearing official finds that the household member did not commit intentional Program violation, provide a written notice which informs the household member of the decision.

If the hearing official finds that the household member committed intentional Program violation, provide written notice to the household member prior to disqualification. The notice will inform the household member of the decision and the reason for the decision. In addition, the notice will inform the household member of the date disqualification will take effect. Provide written notice to the remaining household members, if any, of either the allotment they will receive during the period of disqualification or that they must reapply because the certification period has expired. The procedures for handling the income and resources of the disqualified member are described in DSSM 9076.1. A written demand letter for restitution, as described in DSSM 7000 will also be provided.

2023.6 Waived Hearings

Accused individuals have the option to waive their rights to an administrative disqualification hearing (ADH). Household members suspected of intentional Program violations are provided with a written Notice of Waiver of Disqualification hearing for either the Food Stamp Program or appropriate Cash Assistance program. The waiver notice tells the accused individual:

No further administrative appeal procedure exists after an individual waives his/her right to an administrative disqualification hearing and a disqualification penalty imposed. A fair hearing cannot change the disqualification penalty. The household member can seek relief in a court having appropriate jurisdiction.

2023.7 Court Referrals

Refer for prosecution under State statutes those individuals suspected of committing intentional Program violation. If the amount of food stamps or cash benefits suspected of having been obtained by intentional Program violation exceeds $1,000 or if the individual is suspected of committing more than one act of intentional Program violation, DSS will encourage State prosecutors to recommend to the courts that a disqualification penalty be imposed in addition to any other civil or criminal penalties for such violations.

Disqualify an individual found guilty of intentional Program violation for the length of time specified by the court. If the court fails to impose a disqualification period, impose a disqualification period in accordance with the provisions in DSSM 2023.2, unless contrary to the court order. If disqualification is ordered but a date for initiating the disqualification period is not specified, initiate the disqualification period for currently eligible individuals within 45 days of the date the disqualification was ordered. Any other court imposed disqualification will begin within 45 days of the date the court found a currently eligible individual guilty of civil or criminal misrepresentation or fraud.

Decision notification requirements set forth in DSSM 2023.5 (9) pertain for administrative as well as court‑ordered disqualification.

2023.8 Disqualification Consent Agreements for Deferred Adjudication

A determination of guilt is not always obtained from a court because the accused individual either met the terms of a court order or is not prosecuted because the individual met the terms of an agreement with the prosecutor. For these cases of deferred adjudication, the individual is allowed to sign a disqualification consent agreement to avoid further prosecution.

The disqualification consent agreement tells the accused individual:

If the waiver is signed, the imposition of the disqualification penalties follows the same procedures listed in 2023.5.

2023.9 Reporting Requirements for the Food Stamp Program

Report to FNS information concerning individuals disqualified for intentional Program violation including those individuals disqualified based on the determination of an administrative disqualification hearing official or a court of appropriate jurisdiction. This information will be submitted to FNS so that it is received no later than 30 days after the date the disqualification took effect.

All data submitted by State agencies will be available for use by any State Welfare Agency. State agencies will, at a minimum, use the data for the following:

1. To determine the eligibility of individual Program applicants prior to certification in cases where the Division has reason to believe a household member is subject to disqualification in another political jurisdiction, and

2. To ascertain the appropriate penalty to impose, based on past disqualification.

State agencies may also use the data in other ways, such as the following:

1. To screen all program applicants prior to certification, and

2. To periodically match the entire list of disqualified individuals against their current caseload.

The disqualification of an individual for intentional Program violation in one political jurisdiction will be valid in another. However, one or more fraud disqualifications which occurred prior to the implementation of the penalties contained in these regulations will be considered as only one previous disqualification when determining the appropriate penalty to impose in a case under consideration, regardless of where the disqualification(s) took place. Revise previous reports as necessary.

2023.10 Reversed Disqualification

In cases where the determination of intentional Program violation is reversed by a court of appropriate jurisdiction, reinstate the individual in the program(s) if the household is eligible. Restore benefits that were lost as a result of the disqualification in accordance with DSSM 9011.5.

**History**
- *18 DE Reg. 139 (08/01/14)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *18 DE Reg. 139 (08/01/14)*
- *9 DE Reg. 1368 (03/01/06)*
- *13 DE Reg. 661 (11/01/09)*
- *8 DE Reg. 1153 (2/1/05)*
- *9 DE Reg. 1756 (5/1/06)*
- *9 DE Reg. 1756 (5/1/06)*
- *15 DE Reg. 1025 (01/01/12)*
- *18 DE Reg. 142 (08/01/14)*
- *10 DE Reg. 1007 (12/01/06)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *9 DE Reg. 1370 (03/01/06)*
- *16 DE Reg. 874 (02/01/13)*
- *10 DE Reg. 1441 (03/01/07)*
- *24 DE Reg. 1009 (05/01/21)*
- *7 DE Reg. 647 (11/01/03)*
- *15 DE Reg. 1616 (05/01/12)*
- *21 DE Reg. 722 (03/01/18)*

##### **16 Del. Admin. Code § 2000-2024** Disqualifying Individuals for the Fraudulent Receipt of Benefits in Multiple States {#sec-2000-2024 omnilex-key=us-de-regs-official--title-16--2000-2024}

42 USC 608 (a)(8); 7 CFR 273.16 (b)(5)

Individuals who have been found guilty of fraudulently receiving cash assistance or food benefits in multiple states are disqualified from receiving these benefits.

1. Disqualification Criteria for Cash Assistance Recipients

A. An individual is ineligible to receive cash assistance as a member of any assistance unit if the individual:

i. Made a fraudulent statement or representation of the individual's place of residence to receive assistance from two or more states simultaneously; and

ii. Was convicted in federal or state court for this offense.

B. The individual is disqualified from receiving cash assistance for a 10-year period beginning on the conviction date.

C. The disqualification applies to programs funded under Title IV, Title XIX, and Title XVI of the Social Security Act and the Food and Nutrition Act of 2008.

D. The disqualification does not apply to an individual for whom the President of the United States has granted a pardon for the conviction.

E. DSS case workers must:

i. Determine the income, resources, and deductions according to DSSM 4003.2 if the disqualified individual is a parent payee; or

ii. Exclude the income and resources of the disqualified individual if the individual is a non-parent payee.

2. Disqualification Criteria for Food Benefit Recipients

A. An individual is ineligible to receive food benefits as a member of any household if the individual:

i. Made a fraudulent statement or representation of the individual's place of residence or identity to receive assistance from two or more states simultaneously; and

ii. Was convicted in federal or state court, was found guilty as the result of an Administrative Disqualification Hearing, or signed a waiver of the right to an Administrative Disqualification Hearing for this offense.

B. The individual is disqualified from receiving food benefits for a 10-year period beginning no later than the second month following the date the individual receives written notice of the disqualification.

C. DSS case workers must:

i. Determine the income, resources, and deductions of the disqualified individual according to DSSM 9076.1.

**History**
- *18 DE Reg. 139 (08/01/14)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *18 DE Reg. 139 (08/01/14)*
- *9 DE Reg. 1368 (03/01/06)*
- *13 DE Reg. 661 (11/01/09)*
- *8 DE Reg. 1153 (2/1/05)*
- *9 DE Reg. 1756 (5/1/06)*
- *9 DE Reg. 1756 (5/1/06)*
- *15 DE Reg. 1025 (01/01/12)*
- *18 DE Reg. 142 (08/01/14)*
- *10 DE Reg. 1007 (12/01/06)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *9 DE Reg. 1370 (03/01/06)*
- *16 DE Reg. 874 (02/01/13)*
- *10 DE Reg. 1441 (03/01/07)*
- *24 DE Reg. 1009 (05/01/21)*
- *7 DE Reg. 647 (11/01/03)*
- *15 DE Reg. 1616 (05/01/12)*
- *21 DE Reg. 722 (03/01/18)*

##### **16 Del. Admin. Code § 2000-2025** Disqualification of Individuals Fleeing to Avoid Prosecution or Custody and Probation {#sec-2000-2025 omnilex-key=us-de-regs-official--title-16--2000-2025}

For Cash Benefits:

For Food Stamps:

**History**
- *18 DE Reg. 139 (08/01/14)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *18 DE Reg. 139 (08/01/14)*
- *9 DE Reg. 1368 (03/01/06)*
- *13 DE Reg. 661 (11/01/09)*
- *8 DE Reg. 1153 (2/1/05)*
- *9 DE Reg. 1756 (5/1/06)*
- *9 DE Reg. 1756 (5/1/06)*
- *15 DE Reg. 1025 (01/01/12)*
- *18 DE Reg. 142 (08/01/14)*
- *10 DE Reg. 1007 (12/01/06)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *9 DE Reg. 1370 (03/01/06)*
- *16 DE Reg. 874 (02/01/13)*
- *10 DE Reg. 1441 (03/01/07)*
- *24 DE Reg. 1009 (05/01/21)*
- *7 DE Reg. 647 (11/01/03)*
- *15 DE Reg. 1616 (05/01/12)*
- *21 DE Reg. 722 (03/01/18)*

##### **16 Del. Admin. Code § 2000-2026** Disqualification of Convicted Individuals for Trafficking {#sec-2000-2026 omnilex-key=us-de-regs-official--title-16--2000-2026}

Individual convicted of trafficking food stamp benefits of $500 or more shall be permanently disqualified from receiving food stamp benefits.

Determine the income, resources and deductions of these disqualified individuals according to DSSM 9076.1 .

**History**
- *18 DE Reg. 139 (08/01/14)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *18 DE Reg. 139 (08/01/14)*
- *9 DE Reg. 1368 (03/01/06)*
- *13 DE Reg. 661 (11/01/09)*
- *8 DE Reg. 1153 (2/1/05)*
- *9 DE Reg. 1756 (5/1/06)*
- *9 DE Reg. 1756 (5/1/06)*
- *15 DE Reg. 1025 (01/01/12)*
- *18 DE Reg. 142 (08/01/14)*
- *10 DE Reg. 1007 (12/01/06)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *9 DE Reg. 1370 (03/01/06)*
- *16 DE Reg. 874 (02/01/13)*
- *10 DE Reg. 1441 (03/01/07)*
- *24 DE Reg. 1009 (05/01/21)*
- *7 DE Reg. 647 (11/01/03)*
- *15 DE Reg. 1616 (05/01/12)*
- *21 DE Reg. 722 (03/01/18)*

##### **16 Del. Admin. Code § 2000-2027** Disqualification of Individuals Convicted of Drug Related Offenses {#sec-2000-2027 omnilex-key=us-de-regs-official--title-16--2000-2027}

[Repealed - See 21 DE Reg. 722 (03/01/18)]

**History**
- *18 DE Reg. 139 (08/01/14)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *23 DE Reg. 53 (07/01/19)*
- *18 DE Reg. 139 (08/01/14)*
- *9 DE Reg. 1368 (03/01/06)*
- *13 DE Reg. 661 (11/01/09)*
- *8 DE Reg. 1153 (2/1/05)*
- *9 DE Reg. 1756 (5/1/06)*
- *9 DE Reg. 1756 (5/1/06)*
- *15 DE Reg. 1025 (01/01/12)*
- *18 DE Reg. 142 (08/01/14)*
- *10 DE Reg. 1007 (12/01/06)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *18 DE Reg. 142 (08/01/14)*
- *9 DE Reg. 1370 (03/01/06)*
- *16 DE Reg. 874 (02/01/13)*
- *10 DE Reg. 1441 (03/01/07)*
- *24 DE Reg. 1009 (05/01/21)*
- *7 DE Reg. 647 (11/01/03)*
- *15 DE Reg. 1616 (05/01/12)*
- *21 DE Reg. 722 (03/01/18)*

#### **3000** Technical Eligibility for Cash Assistance

##### **16 Del. Admin. Code § 3000** Defining Delaware’s Temporary Assistance for Needy Families (TANF) Program {#sec-3000 omnilex-key=us-de-regs-official--title-16--3000}

Statutory Authority

45 CFR §260.20

The Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (PRWORA) modified the Social Security Act and established the TANF program. TANF is a federally funded cash assistance program designed to assist low-income families with minor children in the home.

1. States receive block grants to design and operate programs that accomplish the federal purposes of

TANF.

A. The four federal purposes of TANF are to:

i. Provide assistance to needy families so that children can be cared for in their own homes

or in the homes of relatives;

ii. End the dependence of needy parents by promoting job preparation, work, and marriage;

iii. Prevent and reduce the incidence of out-of-wedlock pregnancies; and

iv. Encourage the formation and maintenance of two-parent families.

2. Delaware's TANF program is operated by the Division of Social Services (DSS) and provides cash

assistance for minor children who are:

A. The key objectives of Delaware's TANF Program are to:

i. Provide access to opportunities and services that support the capacity to earn a living

wage.

ii. Reduce barriers to increase the possibility for long term self-sufficiency.

iii. Promote the stabilization of all families.

B. The State and the family have mutual responsibilities.

i. The State will provide cash assistance, case management, supportive services, and

employment and training services to increase the family's opportunity for self-sufficiency.

ii. The family must comply with required TANF components and may participate in

programs that focus on their individualized needs in order to accomplish their personal

goals.

C. DSS creates programs for TANF eligible families and non-custodial parents of TANF minors

based on the four federal TANF purposes and the key objectives of Delaware's TANF

program. These programs are outlined in Delaware's TANF State Plan.

3000.1 Funding the TANF Program

Statutory Authority

45 CFR §201, §261, §263, §264, §265, §270, §283

The Temporary Assistance for Needy Families (TANF) program is a capped Federal Block Grant made available to the states to provide cash assistance to needy families with minor children.

1. The amount of TANF funds available to each state is determined by a formula which considers the amount each state expended for needy families in the years just prior to the enactment of The Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (PRWORA).

2. States may qualify for contingency funds if the state exhibits low economic conditions in one of two ways:

A. States may be required to return a portion of their contingency funds based on total state spending during the year.

3. States must limit the amount spent on administrative costs to no more than 15% of the total of the state’s grant.

4. States may be penalized and the state’s grant may be reduced for failing to:

3000.2 TANF and SSI Recipients

3000.3 TANF and Foster Care

3000.4 TANF and State Only Foster Care

If a child is living with a minor parent and the minor parent receives State Only Foster Care payments, the child may receive cash assistance. The minor parent cannot be included in the cash assistance program.

The minor parent may be a TANF payee if she cares for the child and is capable of handling funds. Contact the minor parent's Child Protective Services worker for this determination.

If someone other than the minor parent cares for the child or if the minor parent is not capable of handling funds, an adult in the household may be payee.

The minor parent is not included in the TANF grant and the State Only Foster Care payment is not considered income to the child.

3000.5 Foster Care Case Processing

The Title IV-E Eligibility worker within the Department of Services to Children, Youth and Their Families will determine if the child is eligible for Title IV-E funds. A child could be in foster care for a period of time before the IV-E eligibility determination is made. The child receives State Only Foster Care payments until Title IV-E eligibility is established. The Title IV-E Eligibility Worker will notify the DSS Social Worker when the Title IV-E determination is completed and the starting date for Title IV-E matching funds. The DSS Social Worker will contact the Title IV-E Eligibility Worker (phone number: 633-2517) at each application and redetermination to determine the foster care funding source. If the funding changes from State Only Foster Care to Title IV-E Foster Care, close the child's cash assistance grant.

**History**
- *14 DE Reg. 304 (10/01/10)*
- *25 DE Reg. 534 (11/01/21)*
- *25 DE Reg. 534 (11/01/21)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1370 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1235 (02/01/06)*
- *12 DE Reg. 793 (12/01/08)*
- *12 DE Reg. 793 (12/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/01/05)*
- *10 DE Reg. 706 (10/01/06)*
- *11 DE Reg. 1241 (03/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *9 DE Reg. 1372 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (05/01/05)*
- *9 DE Reg. 798 (11/01/05)*
- *Repealed 10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *9 DE Reg. 798 (11/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *9 DE Reg. 1978 (06/01/06)*
- *28 DE Reg. 673 (03/01/25)*
- *28 DE Reg. 673 (03/01/25)*
- *10 DE Reg. 706 (10/01/06)*
- *26 DE Reg. 964 (05/01/23)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg 773 (03/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *23 DE Reg. 63 (07/01/19)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *8 DE Reg. 1712 (06/01/05)*
- *10 DE Reg. 1700 (05/01/07)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1979 (06/01/06)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *8 DE Reg. 1024 (1/1/05)*
- *8 DE Reg. 1618 (5/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1024 (1/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *13 DE Reg. 1209 (03/01/10)*
- *16 DE Reg. 641 (12/01/12)*

##### **16 Del. Admin. Code § 3000-3001** Definitions {#sec-3000-3001 omnilex-key=us-de-regs-official--title-16--3000-3001}

The following words and terms, when used in the context of these policies, will, unless clearly indicated otherwise, have the following meanings:

A. Benefits (Non-Time-Limited) - the receipt of TANF benefits that are not subject to a time limitation.

Benefits (Time-Limited) - the receipt of TANF benefits for a limited period of time.

B. Caretaker (Needy) - a parent or non-parent included in the grant who is caring for a needy child. Needy caretakers are required to comply with the CONTRACT OF MUTUAL RESPONSIBILITY to receive benefits. Needy caretakers are subject to the time limit requirements.

Caretaker (Non-Needy) - a non-parent, not included in the grant, who is caring for a needy child. Non-needy caretakers are required to comply with the CONTRACT OF MUTUAL RESPONSIBILITY to receive benefits. Non-needy caretakers are not subject to the time limit requirements. These caretakers will receive benefits under the Children's Program.

C. Children's program - the name of the agency's program for persons who receive non-time-limited benefits. Persons in this program are not subject to the usual time limits for the receipt of benefits. However, persons in this program must comply with a non-work-related CONTRACT OF MUTUAL RESPONSIBILITY, e.g., participation in parenting classes, school attendance for the child or immunizations as necessary.

D. Contract of Mutual Responsibility – an agreement between the TANF client and the agency which sets obligations and expectations between the TANF client and agency in exchange for benefits.

E. Cumulative Months - the total number of months, not necessarily consecutive months, which make up a particular time period.

F. Delaware’s Temporary Assistance for Needy Families (TANF) Program - the title of Delaware's new welfare reform program.

G. Employable - the ability to engage in activities necessary to acquire and retain a job, at a wage level at least equal to the minimum wage; an employable person is physically and mentally able to participate in employment or activities necessary to seek and obtain employment, e.g. job search, job training, job readiness, etc. While an individual is employable the receipt of benefits is time-limited.

H. Employment (Subsidized) - a public or private sector job for which the employer receives a grant or allotment to pay all or a portion of the employee’s wage.

Employment (Unsubsidized) - a public or private sector job for which the employer receives no grant or allotment to pay either all or a portion of the employee's wage.

I. Good Cause - An adult recipient may have legitimate reasons for not cooperating either in the development of the Contract of Mutual Responsibility or the requirements as set forth in the Contract. The adult recipient has "good cause" when either a circumstance or condition exists in either her/his personal or family situation beyond which she/he has no control, and which would prevent cooperation and/or participation.

Good cause for quitting a job would include but not necessarily be limited to:

On the job discrimination;

Health and/or safety risk.

J. Pay After Performance - A work experience and/or Employment and Training program required for families with employable adults where the adult has not found employment or has lost a job. Families who were continuously on TANF prior to 01/01/2000 will have 24 months before being required to enter into this program. Families reapplying on or after 01/01/2000 will immediately enter this program. Participants will work to earn TANF benefits.

K. Sanction - a penalty for TANF client’s failure or refusal without good cause to meet her/his Employment and Training participation requirements. If the client refuses or fails to meet work related requirements (job search, training, etc.) or quits a job without good cause, the client’s TANF case will be closed. If the TANF client refuses or fails to attend a Contract of Mutual Responsibility requirement (e.g., participate in parenting education) the penalty is a $50.00 reduction in the grant for each month the client refuses or fails to participate.

L. Suitable Employment - employment that provides income at least equal to the payment standard after deduction of work expenses, the TANF work deduction and child care as paid, and provides wages at least equal to the minimum wage. Individuals will be expected to work at jobs that are below their skill levels, if such positions provide the only available employment.

M. Two Parent Program - able-bodied parents and their children who meet the standard of need and all TANF eligibility requirements, except deprivation, will be eligible for cash benefits. Eligibility for this program is based on need; there is no deprivation requirement. Cash benefits are time limited and both parents must comply with a Contract of Mutual Responsibility.

When one parent in an intact family is incapacitated, the family should not be placed in the two-parent program.

N. Unemployable - the inability to engage in activities necessary to work for at least the minimum wage; the person is prohibited because s/he is physically or mentally disabled. An unemployable individual cannot participate in employment or activities necessary to seek and obtain employment, e.g., job search, job training, job readiness, etc.

The determination and duration of unemployability are made by a health care professional (e.g., doctor, nurse, nurse practitioner, therapist, etc.). Periods of unemployability are not counted toward the cumulative months of benefit eligibility under the time-limited program.

O. Week - A week is defined as seven consecutive days, Monday through Sunday.

P. Work-eligible individual - an adult (or minor child head-of-household) receiving assistance under TANF or a separate State program or a non-recipient parent living with a child receiving assistance (child-only cases). See exclusions below.

Q. Excluded work-eligible individuals - Child-only cases that are:

Other work-eligible exclusions: A parent providing care for a disabled family member living in the home, who does not attend school on a full-time basis, provided that the need for such care is supported by medical documentation.

**History**
- *14 DE Reg. 304 (10/01/10)*
- *25 DE Reg. 534 (11/01/21)*
- *25 DE Reg. 534 (11/01/21)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1370 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1235 (02/01/06)*
- *12 DE Reg. 793 (12/01/08)*
- *12 DE Reg. 793 (12/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/01/05)*
- *10 DE Reg. 706 (10/01/06)*
- *11 DE Reg. 1241 (03/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *9 DE Reg. 1372 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (05/01/05)*
- *9 DE Reg. 798 (11/01/05)*
- *Repealed 10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *9 DE Reg. 798 (11/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *9 DE Reg. 1978 (06/01/06)*
- *28 DE Reg. 673 (03/01/25)*
- *28 DE Reg. 673 (03/01/25)*
- *10 DE Reg. 706 (10/01/06)*
- *26 DE Reg. 964 (05/01/23)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg 773 (03/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *23 DE Reg. 63 (07/01/19)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *8 DE Reg. 1712 (06/01/05)*
- *10 DE Reg. 1700 (05/01/07)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1979 (06/01/06)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *8 DE Reg. 1024 (1/1/05)*
- *8 DE Reg. 1618 (5/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1024 (1/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *13 DE Reg. 1209 (03/01/10)*
- *16 DE Reg. 641 (12/01/12)*

##### **16 Del. Admin. Code § 3000-3002** Time Limit, Temporary Welfare Program {#sec-3000-3002 omnilex-key=us-de-regs-official--title-16--3000-3002}

Cash benefits will be time-limited for households headed by two employable adults age 18 or older who are included in the grant. For households applying on or after 01/01/2000, the lifetime time limit will be thirty-six (36) cumulative months.

Time limits apply when three conditions are met:

When one or more of the conditions listed above is not met, the family receives benefits in the non-time limited program known as the Children’s Program.

During the time-limited period, employable adult recipients will receive full cash benefits only as long as they fulfill their Contract of Mutual Responsibility and they are meeting the minimum weekly hours of required employment and training activities.

Periodic Alerts to Families Regarding Time Remaining before the Family Reaches the Time Limit

The Division will track the time remaining before a family’s time limits expire and alert the family. The Division will notify families on a quarterly basis of the time they have remaining before the time limits expire.

3002.1 Two-Parent Families - Time Limit, Temporary Welfare Program

A. Delaware Temporary Assistance to Needy Families cash benefits are time-limited for a household headed by two employable adults age 18 or older who are included in the grant. For households applying on or after 01/01/2000, the lifetime time limit will be thirty-six (36) cumulative months.

Time limits apply when three conditions are met:

When one or more of the conditions listed above is not met, the family receives benefits in the non-time limited program known as the Children’s Program.

B. During the time-limited period, employable adult recipients will receive full cash benefits only as long as they fulfill their Contract of Mutual Responsibility, and they are meeting the minimum weekly hours of required employment and training activities.

C. Periodic Alerts to Families Regarding Time Remaining before the Family Reaches the Time Limit

The Division will track the time remaining before a family’s time limits expire and alert the family. The Division will notify families on a quarterly basis of the time they have remaining before the time limits expire.

3002.2 Single Parent / Non-Parent Caretaker Families

Under Delaware's Temporary Assistance To Needy Families, cash benefits will be time-limited for households headed by an employable adult age 18 or older who is included in the grant. For households applying on or after 01/01/2000 the lifetime time limit will be thirty-six (36) cumulative months.

Time limits apply when three conditions are met:

When one or more of the conditions listed above is not met, the family receives benefits in the non-time-limited program known as the Children’s Program.

3002.3 Time Limits For Single Parent and Two Parent Families on Assistance Prior to 01/01/2000

If a family was headed by an employable adult age 18 or older who was included in the grant and received Temporary Assistance for Needy Families (TANF) cash benefits prior to 01/01/2000 they had a forty-eight (48) cumulative month time limit. This lifetime limit will still apply for those families.

3002.4 Periodic Alerts to Families Regarding Time Remaining Before the Family Reaches the Time Limit

The Division will track the time remaining before a family’s time limits expire and alert the family. The Division will notify families on a quarterly basis of the time they have remaining before the time limits expire.

3002.5 Assessment Prior to Termination of Benefits

If requested by the client prior to the end of the 36 or 48 cumulative month period in which a family has received assistance (through cash assistance and participation in pay-after-performance), the Division will complete another assessment of employability. If the Division determines that the adult caretaker is not employable, the Division will continue benefits under the Children's Program as described in Section 3003. If the Division determines that the adult caretaker is employable, TANF benefits will end to the family as of the last day of the 36 or 48 cumulative months.

3002.6 Noticing Prior to Termination of Benefits

At least 90 days prior to the end of the 36 or 48 cumulative month period in which a family has received assistance, the Division will remind the family that assistance will end and notify the family of the right to apply for an extension.

3002.7 Extensions

The Division will limit extensions to those families who can demonstrate that:

or

The Division Director or the Director's designee will make decisions on granting extensions within 45 days of the request. Fair hearing provisions set forth in Section 5000 apply. Benefits will not continue beyond the time limit.

The Division will not grant extensions if:

The responsibility rests with the adult caretaker to demonstrate substantiality. It is not enough for the adult caretaker to simply make a claim that the agency failed in its effort to provide the services specified under the Contract of Mutual Responsibility. The adult caretaker must present the reasons for the claim and show how the agency failed to provide these services.

3002.8 Re-Application after the Time Limit

Assistance will be denied to employable caretakers reapplying for benefits after the time limit has expired, unless the caretaker proves that grounds exist for an extension.

Benefits will be provided to these families only in the pay-after-performance component, up to the federal maximum of sixty (60) cumulative months in the time-limited program (See DSSM 3002.9). DSS will conduct an assessment and notice the family prior to termination of benefits (See DSSM 3002.5).

Families headed by unemployable caretakers can receive assistance under the Children's Program.

3002.9 Exceptions to the Time Limit Counter

Repealed

**History**
- *14 DE Reg. 304 (10/01/10)*
- *25 DE Reg. 534 (11/01/21)*
- *25 DE Reg. 534 (11/01/21)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1370 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1235 (02/01/06)*
- *12 DE Reg. 793 (12/01/08)*
- *12 DE Reg. 793 (12/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/01/05)*
- *10 DE Reg. 706 (10/01/06)*
- *11 DE Reg. 1241 (03/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *9 DE Reg. 1372 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (05/01/05)*
- *9 DE Reg. 798 (11/01/05)*
- *Repealed 10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *9 DE Reg. 798 (11/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *9 DE Reg. 1978 (06/01/06)*
- *28 DE Reg. 673 (03/01/25)*
- *28 DE Reg. 673 (03/01/25)*
- *10 DE Reg. 706 (10/01/06)*
- *26 DE Reg. 964 (05/01/23)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg 773 (03/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *23 DE Reg. 63 (07/01/19)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *8 DE Reg. 1712 (06/01/05)*
- *10 DE Reg. 1700 (05/01/07)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1979 (06/01/06)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *8 DE Reg. 1024 (1/1/05)*
- *8 DE Reg. 1618 (5/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1024 (1/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *13 DE Reg. 1209 (03/01/10)*
- *16 DE Reg. 641 (12/01/12)*

##### **16 Del. Admin. Code § 3000-3003** Non-Time Limited Program - Children's Program {#sec-3000-3003 omnilex-key=us-de-regs-official--title-16--3000-3003}

DELAWARE'S TEMPORARY ASSISTANCE FOR NEEDY FAMILIES WELFARE REFORM PROGRAM creates a non-time-limited program for certain families, referred to as the Children's Program. Families with the following status will receive benefits in the Children's Program:

In cases for which the family is placed in the Children’s program because the parent (or other caretaker relative) is caring for a disabled family member, DSS will obtain a statement from a medical or licensed behavioral health professional or have the DSS Medical Certification form completed by a medical professional to verify that the person is needed in the home to care for the disabled family member.

CONTRACT OF MUTUAL RESPONSIBILITY requirements and sanctions for non-compliance apply to families in the Children's Program.

**History**
- *14 DE Reg. 304 (10/01/10)*
- *25 DE Reg. 534 (11/01/21)*
- *25 DE Reg. 534 (11/01/21)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1370 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1235 (02/01/06)*
- *12 DE Reg. 793 (12/01/08)*
- *12 DE Reg. 793 (12/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/01/05)*
- *10 DE Reg. 706 (10/01/06)*
- *11 DE Reg. 1241 (03/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *9 DE Reg. 1372 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (05/01/05)*
- *9 DE Reg. 798 (11/01/05)*
- *Repealed 10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *9 DE Reg. 798 (11/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *9 DE Reg. 1978 (06/01/06)*
- *28 DE Reg. 673 (03/01/25)*
- *28 DE Reg. 673 (03/01/25)*
- *10 DE Reg. 706 (10/01/06)*
- *26 DE Reg. 964 (05/01/23)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg 773 (03/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *23 DE Reg. 63 (07/01/19)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *8 DE Reg. 1712 (06/01/05)*
- *10 DE Reg. 1700 (05/01/07)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1979 (06/01/06)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *8 DE Reg. 1024 (1/1/05)*
- *8 DE Reg. 1618 (5/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1024 (1/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *13 DE Reg. 1209 (03/01/10)*
- *16 DE Reg. 641 (12/01/12)*

##### **16 Del. Admin. Code § 3000-3004** Caretakers in TANF Families {#sec-3000-3004 omnilex-key=us-de-regs-official--title-16--3000-3004}

Assistance is provided to needy families. A family is one or more children living with a specified relative, guardian, or custodian (adult acting in loco parentis).

Specified relative is defined as:

For the purposes of the TANF program a guardian is defined as:

A custodian or an adult acting in loco parentis ("in the place of a parent") is defined as:

An adult who provides an appropriate supportive living arrangement for the child(ren) in his/her care, and who has:

Adults acting in loco parentis are required to acknowledge their acceptance of the legal responsibility for the child(ren) in their care and their intentional acceptance of the day-to-day care, custody, and control of the child(ren) in their care. This acknowledgement must be in writing and on a Division of Social Services approved form.

The Division of Family Services (DFS), within the Department of Services for Children, Youth, and Their Families (DSCYF) must approve the living arrangement of a custodian and the children they are caring for by the next redetermination. If verification of consent and approval by DFS is not provided by the next redetermination, TANF payments should be stopped.

Paternity Establishment:

When a child lives with both the natural father and the mother but paternity has not been legally established, refer the parents to the Division of Child Support Enforcement (DCSE) for a voluntary acknowledgement of paternity. If the alleged father is unwilling to complete the voluntary acknowledgement of paternity, DSS will consider the child deprived of the care and support of his/her father. Refer the case to DCSE for follow-up on establishing paternity.

When a child lives with the natural father, but paternity has not been legally established, have the father complete a declaration of natural relationship document. Obtain one additional document from the documents listed below to support the natural father's claim of relationship.

When a child lives with a relative of the natural father, but paternity has not been legally established, have the relative complete a Declaration of Natural Relationship document. Obtain one additional document from the documents listed above to support the relative's claim of relationship.

3004.1 Living in the home

The parent's or caretaker's statement that the child is living in the home must be verified at the time of application and at each subsequent redetermination.

A home is defined as the family setting where the child and the caretaker reside. The home exists even if the child or caretaker is temporarily absent (See DSSM 3023.4, 3023.5, and 3023.6).

The child is considered living with the caretaker even if the child is under the jurisdiction of the court (e.g., receiving probation services or protective supervision) or legal custody is held by an agency, as long as the child continues to live at home.

3004.1.1 Joint Custody

The home exists even if the responsible caretaker relative or child is temporarily absent per DSSM 3023.4, 3023.5, and 3023.6 for TANF purposes. Joint custody cases can complicate deciding if a child is eligible for TANF and with which specified relative.

The Division of Social Services uses the following terms and definitions. (Note: The court system may use similar terms having different definitions.)

Joint Custody-Two parties are given the control to make major life decisions for a child. Joint custody exists when two parties are given, by court decree, the responsibility for making the major decisions in a child's life. This also covers shared custody situations. (This is not meant to be an exhaustive list but a guide. There may be other decisions that fall into this category.) Major life decisions revolve around:

The Division of Social Services provides that in joint custody situations, the first party to apply for and have eligibility determined for TANF can receive it for that child. This is permitted, whether or not the party in the joint custody case has the primary residence of the child. We allow this situation because the child will have just one parent providing the day-to-day care or no parent providing the day-to-day care at any given time. This only applies in joint custody cases.

When both parties in the joint custody arrangement wish to receive TANFB at the same time:

The party with whom the child resides most of the time and the party who maintains the daily care and control of the child will be able to receive TANF for that child. If both parties have equal time and decision making for the child each month, then the party that applies first will be able to receive the TANF benefits.

**History**
- *14 DE Reg. 304 (10/01/10)*
- *25 DE Reg. 534 (11/01/21)*
- *25 DE Reg. 534 (11/01/21)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1370 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1235 (02/01/06)*
- *12 DE Reg. 793 (12/01/08)*
- *12 DE Reg. 793 (12/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/01/05)*
- *10 DE Reg. 706 (10/01/06)*
- *11 DE Reg. 1241 (03/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *9 DE Reg. 1372 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (05/01/05)*
- *9 DE Reg. 798 (11/01/05)*
- *Repealed 10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *9 DE Reg. 798 (11/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *9 DE Reg. 1978 (06/01/06)*
- *28 DE Reg. 673 (03/01/25)*
- *28 DE Reg. 673 (03/01/25)*
- *10 DE Reg. 706 (10/01/06)*
- *26 DE Reg. 964 (05/01/23)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg 773 (03/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *23 DE Reg. 63 (07/01/19)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *8 DE Reg. 1712 (06/01/05)*
- *10 DE Reg. 1700 (05/01/07)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1979 (06/01/06)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *8 DE Reg. 1024 (1/1/05)*
- *8 DE Reg. 1618 (5/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1024 (1/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *13 DE Reg. 1209 (03/01/10)*
- *16 DE Reg. 641 (12/01/12)*

##### **16 Del. Admin. Code § 3000-3005** Child Support {#sec-3000-3005 omnilex-key=us-de-regs-official--title-16--3000-3005}

As part of the TANF eligibility process, all applicants must assign to the State of Delaware their rights to receive spousal support for themselves and child support for the dependent children in their care. As part of this process, applicants and recipients must cooperate, unless good cause is established, in:

1. Identifying and locating absent parents;

2. Establishing paternity for dependent children born out of wedlock; and

3. Establishing support payments and/or other properties for the dependent child.

The Division of Child Support Enforcement (DCSE) is the single State agency that is empowered to:

Establish paternity of and secure support for children born out of wedlock;

Secure support from parents who have abandoned or deserted their children; and

Enter cooperative arrangements with appropriate courts and law enforcement officials in order to establish support.

Before approving a TANF grant, DSS will refer applicants to the DCSE to begin the process of securing support payments. While assistance is received, any spousal or child support payments made on behalf of a recipient will be paid to DCSE. The first $50 of support that is collected by DCSE each month will be returned to the TANF recipient. These payments will be sent to the recipient the month following the month the support is collected. All remaining support payments will be retained by the State while the TANF case is active.

The assignment of support rights covers all TANF recipients, including pregnant women who receive a check in their ninth month of pregnancy, and persons who are eligible for a grant but do not receive a check because the need for assistance is less than $10. In the latter case, DCSE will not retain support payments.

Even though support payments are retained by the State while an individual is a TANF recipient, these payments are considered in determining initial and continuing financial eligibility. Refer to DSSM 4005.1 for a complete discussion of support payments and financial eligibility.

See Administrative Notices: A-23-98; A-07-2001; A-10-2001; A-12-2001

3005.1 Cooperation Responsibilities

Clients must cooperate with the Division of Child Support Enforcement (DCSE) as a condition of eligibility. All families are required to provide sufficient information to permit Delaware to obtain Child Support on behalf of the family. Exceptions can be made when the caretaker demonstrates that pursuit of Child Support would create a danger to the caretaker or the child(ren). It is the responsibility of the client to provide documentation to verify such a Good Cause claim.

In order to identify and locate absent parents, establish paternity, and obtain support payments and/or other property, applicants or recipients of TANF are required to participate in the following activities, if relevant:

1. To appear at an office of DSS or the Division of Child Support Enforcement to provide verbal or written information or documentary evidence known to or possessed by the applicant or recipient;

2. To appear as a witness at judicial or other hearings or proceedings;

3. To provide information or to attest to the lack of information under penalty of perjury;

4. To pay to the Division of Child Support Enforcement any child support payments received from an absent parent after an assignment has been made.

3005.2 Penalties for Non Cooperation

Failure of a caretaker, without good cause, to cooperate with and provide information to the DCSE to permit the State to pursue the collection of child support on behalf of dependent children will result in a fiscal sanction equal to the TANF benefit, until compliance. Deny the case of applicants who fail to provide information so that the State may pursue child support collections.

3005.3 Curing Child Support Penalties

To cure the child support sanction, the caretaker will provide sufficient information to permit Delaware to pursue child support collections on behalf of needy children.

3005.4 Good cause determination

It is the responsibility of the Division of Child Support Enforcement (DCSE) to determine if good cause for refusing to cooperate exists. When good cause is determined to exist, the applicant may participate in the TANF program and will not be required to cooperate in support collection activities.

3005.5 Enforcement without the caretaker's cooperation

When good cause for non‑ cooperation exists, DCSE must decide whether or not child support enforcement activities can proceed without risk to the child or caretaker if the enforcement activities do not include cooperation. DSS will ask the applicant if he/she believes that enforcement activities can proceed and will relay that information to DCSE.

If a DCSE's recommendation is to proceed with enforcement activities, DSS will notify the applicant and give the applicant the opportunity to withdraw the application or close the case before enforcement activities begin.

3005.6 Fair Hearings

Applicants and recipients have the right to request a fair hearing if they disagree with any DSS or DCSE decision made in regard to the child support assignment, non-cooperation, or good cause claim issues. DCSE will handle the fair hearing requests on issues of non-cooperation and good cause claim.

See Administrative Notice: A-8-99 Child Support Fair Hearing Procedures

3005.7 Assignment of Child Support Rights and Fair Hearings

Applicants and recipients have the right to request a fair hearing if they disagree with any DSS decision made in regard to the child support assignment.

3005.8 Child Support Enforcement Procedures

1. At the eligibility interview, the DSS worker will explain, as outlined on Form 200 and Form 204, the automatic assignment of support rights, the client's responsibilities in relation to securing support and the circumstances that constitute good cause for refusal to cooperate. The applicant and worker will sign Form 200 and Form 204. A copy of each form will be given to the applicant.

2. At the time of application, if applicants have at least the minimum information required for child support case initiation and do not claim good cause, DSS staff should initiate the child support case via the computer. DSS assumes cooperation unless notified by DCSE otherwise.

An interview with the DCSE is waived in the following cases:

a. TANF‑ UP cases where there are no children with absent parents.

b. TANF cases where deprivation is based on incapacity.

c. TANF cases in which good cause has been determined to exist. Good cause is determined by DCSE.

d. TANF reapplications or supplemental applications where the caretaker has previously cooperated with the Division, and the absent parents involved in the case are the same individuals that were involved when the case was previously open.

3. When the DCSE indicates that the caretaker has been uncooperative, the TANF case is closed.

If good cause is claimed, the client is asked to provide evidence to verify the claim to DCSE.

**History**
- *14 DE Reg. 304 (10/01/10)*
- *25 DE Reg. 534 (11/01/21)*
- *25 DE Reg. 534 (11/01/21)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1370 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1235 (02/01/06)*
- *12 DE Reg. 793 (12/01/08)*
- *12 DE Reg. 793 (12/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/01/05)*
- *10 DE Reg. 706 (10/01/06)*
- *11 DE Reg. 1241 (03/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *9 DE Reg. 1372 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (05/01/05)*
- *9 DE Reg. 798 (11/01/05)*
- *Repealed 10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *9 DE Reg. 798 (11/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *9 DE Reg. 1978 (06/01/06)*
- *28 DE Reg. 673 (03/01/25)*
- *28 DE Reg. 673 (03/01/25)*
- *10 DE Reg. 706 (10/01/06)*
- *26 DE Reg. 964 (05/01/23)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg 773 (03/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *23 DE Reg. 63 (07/01/19)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *8 DE Reg. 1712 (06/01/05)*
- *10 DE Reg. 1700 (05/01/07)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1979 (06/01/06)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *8 DE Reg. 1024 (1/1/05)*
- *8 DE Reg. 1618 (5/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1024 (1/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *13 DE Reg. 1209 (03/01/10)*
- *16 DE Reg. 641 (12/01/12)*

##### **16 Del. Admin. Code § 3000-3006** TANF Employment and Training Program {#sec-3000-3006 omnilex-key=us-de-regs-official--title-16--3000-3006}

Delaware's Temporary Assistance for Needy Families (TANF) welfare reform effort is based on the idea that TANF is a transitional benefit and should not become a way of life. The Division maintains that the way for persons to avoid TANF dependency is for them to find and maintain employment.

3006.1 Mandatory Participants

(45 CFR §261. 22(c))

All adult caretakers and other adults in the assistance unit who are not exempt must participate in Employment and Training related activities. The four possible exemptions are:

A. A single custodial parent caring for a child less than 12 months of age may be exempted from employment and training activities for up to 12 months in the lifetime of the parent.

Single custodial parents who are caring for a child less than 12 months of age and who have not reached their 12 month limit will be exempted from employment and training activities unless they waive their employment and training exemption.

Parents who waive their employment and training exemption are subject to all the conditions and rules of the employment and training program. Parents who waive their employment and training exemption cannot be exempted for caring for a child less than 12 months of age again unless a new biological, step, or adopted child less than 12 months of age is added to the TANF case.

Parents who waive their employment and training exemption must meet the required employment training hours based on their family composition within 14 calendar days of waiving their exemption. Cases which fail to meet the employment and training requirement are subject to a full family sanction.

B. An individual determined unemployable by a health care professional.

C. On a case-by-case basis, clients who are victims of Domestic Violence. [see DSSM 3010.2.1 through DSSM 3010.2.5]

D. A parent caring for a disabled family member* who lives in the home.

* A parent or spouse can be excluded to care for a child or a spouse as long as the following conditions apply:

1. The parent is biological, adoptive or step.

2. The parent or spouse lives in the home with the child.

3. The need for such care is supported by medical documentation.

4. The spouse of a parent can use the caring for exemption even though the marriage is terminated by death or divorce.

Children age 16 or older who are not attending school must participate in work or other alternative activities, e.g., GED.

Individuals who are exempt from Employment and Training requirements can volunteer to participate in the Employment and Training Program. Individuals with disabilities will be afforded the same access, supports and opportunities including reasonable accommodations to participate in the Employment and Training programs.

3006.1.1 Requiring Participating in Employment and Training for One-parent and Single Caretaker Families

This policy applies to TANF families headed by an employable single non-parent caretaker who is included in the grant or an employable single parent caretaker aged 18 or older.

1. Caretakers are required participate with a TANF employment and training vendor.

2. The vendor will develop an individualized employability plan for each participant.

3. The employability plan will detail the weekly countable activities to be completed. The caretaker will receive verbal and written instructions of activity verification requirements].

4. Verifications of activities are required to be submitted the week the activity occurred.

5. Caretakers are required to complete at least 30 hours of countable activities a week.

6. Caretakers who fail to complete the activities or to provide the required verification to the employment and training program will be subject to a sanction.

A. Non-parent caretakers will be removed from the TANF grant

B. Single parent households are subject to the full family sanction rules.

7. The total number of hours the caretaker may engage in work experience or community service is limited by the Fair Labor Standards Act (FLSA).

The maximum required monthly hours of participation in work experience and community service is determined by dividing the combined monthly TANF and food benefits by the greater of the Federal or Delaware minimum wage.

3006.1.2 Requiring Participation in Employment and TRAINING FOR Two-Parent Families

This policy applies to TANF families headed by two employable adults aged 18 or older and who are both included in the TANF grant.

1. Two-Parent families are required to participate with a TANF employment and training vendor.

2. The vendor will design an individualized employability plan for each family.

3. The employability plan will detail the weekly countable activities to be completed. Parents will receive verbal and written instructions of activity verification requirements.

4. A family will receive a full family sanction when:

a. The family does not complete the required hours of planned activities in a week, or

b. The family does not submit the required verification of activities to the employment and training program.

5. Verifications of activities are required to be submitted the week the activity occurred.

6. The two week pre-participation period is not met until both parents have attended an orientation at the Employment and Training provider.

7. One participant may complete all of the required employment and training activities for the household.

8. Two-parent families are required to complete at least 40 hours of countable employment and training activities a week.

9. The total number of hours the adults in a two parent family may engage in work experience or community service is limited by the Fair Labor Standards Act (FLSA).

The maximum required monthly hours of participation in work experience or community service is determined by dividing the combined monthly TANF and food benefits by the higher of the Federal or the Delaware minimum wage.

10. Two -parent families may receive child care designated for participants in the TANF Employment and Training if the following conditions are met:

A. Both adults are participating in verified countable activities.

B. Both adults are engaging in at least 20 hours of activities a week.

The employment and training program will notify the Division of Social Services when the requirements of this policy are not met.

3006.2 TANF Employment and Training Participation and Participation Rates

Under the Temporary Assistance for Needy Families Block Grant, DSS is required to meet the following work participation rates with respect to all families that include an adult or minor child head of household receiving assistance:

DSS may face a lower work participation rate if it experiences a net caseload reduction compared to FY 2005.

Example: If it is determined that DSS' average monthly caseload in FY 2006 was 4 percentage points lower than average monthly caseloads in FY 2005, then, rather than having to meet a 50% work participation rate requirement in FY 2006, the rate would be lowered by 4 percentage points to 46%.

To be counted toward meeting the work participation rate, each individual must meet the required number of hours each week.

Single parents who are not working 30 hours a week or earning an equivalent of 30 hours a week times minimum wage are required to participate in work and/or work related activities. Participation in work and work related activities must equal at least a minimum average of 30 hours a week; and, at least 20 of the hours per week must come from participation in federally defined core activities.

Single parent/caretaker TANF recipients with a child in the TANF household under six are deemed to be engaged in work for a month if the recipient is engaged in federally defined core work activities for an average of at least 20 hours per week during the month.

Two-parent families where one parent is not working at least 35 hours a week or earning the equivalent of 35 hours a week times minimum wage are required to participate in work and/or work related activities. Participation in work and work related activities must equal an average of at least 35 hours a week; and, at least 30 of the hours per week must come from participation in federally defined core activities.

Two parent families who receive federally funded Purchase of Care services who are not working at least 55 hours a week or earning the equivalent of 55 hours a week times minimum wage are required to participate in work and/ or work related activities. Participation in work and work related activities for one parent must equal 35 hours a week. Combined hours of participation in work and work related activities must equal an average of at least 55 hours a week. Of the average 55 hours a week the participants must average at least 50 hours a week of federally defined core activities.

Teen parents are required to attend school, work, or participate in the employment and training activities. Secondary, post-secondary, vocational, training school, and participation in a GED program meets participation requirements for the month and is the equivalent to work. If they are not attending one of the above types of school or working for 30 hours a week they must participate in employment and training activities for 20 or 30 hours a week.

Single custodial parents with a child under 12 months of age are able to receive an exemption from Employment and Training requirements for a total of 12 months in their lifetime.

REQUIRED EMPLOYMENT AND TRAINING HOURS

The monthly participation rate is calculated as follows:

Numerator: # of TANF families with a work-eligible-individual who meet the participation requirement for the month

divided by

Denominator: # of TANF families that include a work-eligible individual, less # of families sanctioned in that month for failure to participate in work (for up to 3 months in preceding 12 month period), less the number of non-needy caretaker households less the number of single custodial parents opting to use one of the 12 months allowable exemptions for caring for a child under one year of age. A parent can only use this exemption for a total of 12 months in his/her lifetime.

3006.2.1 TANF Employment and Training Participants Who Count for TANF Participation

According to provisions of Delaware's Temporary Assistance For Needy Families, the following individuals must participate in work related activities and are included in the denominator for calculating the Federal participation rates.

3006.3 TANF Employment and Training Activities

The Division of Social Services, in conjunction with the Delaware Department of Labor and the Delaware Economic Development Office, has developed employment and training programs to move TANF clients to economic independence. These agencies will conduct initial and ongoing assessments of client employability and appropriateness of employment and training related activities. For individuals deemed unable to work because they are physically or mentally disabled a referral is made to the Division of Vocational Rehabilitation. Use Form 134.

The Division has agreements with the Delaware Department of Labor and the Delaware Economic Development Office to offer employment and training activities.

The goal is to place the adult recipient in an unsubsidized job in as timely a manner as possible. The Department of Labor will have the option of recycling through job search those adult recipients who are unsuccessful in finding work, and/or placing the adult recipient in an alternative work experience, OJT, remediation, or a skills training program. Also, both the Division and the Department of Labor are jointly responsible for the development of an Employability Development Plan.

Although the Department of Labor assumes primary responsibility for assigning adult recipients to employment-related activities for this age group, the Division retains responsibility for sanctions, federal reporting and other TANF requirements.

3006.4 TANF Employment and Training Activities Which Constitute Participation Under TANF

The following are employment-related activities that count as participation:

1. Work supplementation where TANF funds that would otherwise be paid as assistance is paid to employer;

2. Third party contractor, like a temporary staffing agency, serves as employer of record and is paid a fee to cover salary, expenses and success in placing employees; and

3. Supported work for individuals with disabilities in an integrated setting.

1. Preparing an individual to obtain employment, such as preparing a resume or job application, interviewing skills, instruction in work place expectations and life skills; and

2. Substance abuse treatment, mental health treatment, or rehabilitation activities for those who are otherwise employable. A State may only count an individual’s actual hours of participation in treatment or rehabilitation activities.

Participants may be considered an “employee” under the Fair Labor Standards Act (FLSA) broad definition. If so, participants must be compensated at the minimum wage and overtime rules apply

Education and Training

Students who do not meet the Blevins Bill requirements in section 3006.6 can receive 1.5 hours of study time for each credit hour if the education or training class requires homework and study time to be completed outside of class time. A 3-credit course would equal 7.5 hours of participation. (3 + (3 x 1.5) = 7.5. Study hours must be supervised to count towards participation.

If a recipient is attending training or a program that does not have a designated credit hour, a determination of the amount of study time required for this training will have to be determined independently. This will be reported on the General Activity Screen in the DCIS II Employment and Training sub-system. A question will ask if this activity requires study time, if it is answered yes, then a mandatory screen will appear to enter the amount of weekly study hours. The amount of study hours necessary will be determined by the contractor.

The student must be in good standing as it relates to attendance and achievement as defined by the program the student is attending.

Example: A participant who is working 15 hours a week and taking 2 three-credit classes will have a participation rate of 30 hours. (15 hours of work + 6 credit hours of class + 9 hours of study time.

3006.5 TANF Employment and Training Participants Who Count for TANF Participation

3006.6 Senate Bill 101-1999 and Employment & Training Activities

1. The person does not hold a baccalaureate degree.

2. The secondary, post-secondary education up to the baccalaureate level, or vocational training is pursued through an accredited or approved school program.

3. The person is enrolled with enough credit hours to have full-time student status and is in good standing as it relates to attendance and achievement as defined by the program the person is attending.

4. If the person attending school would otherwise be subject to a work requirement in order to receive assistance under TANF, the combination of credit hours and work hours shall equal at least 20 hours per week while the program is in session. This work requirement may be met through work-study, internships, externships, or through work as a research assistant. If possible, during scheduled breaks, the work requirement will be the same as for other program participants, with work experience related to the field of study. However, if the student is enrolled full-time for the next semester and work activity placement cannot be arranged for the duration of the break in classes, it may be excused.

(b) Loans, scholarships, grants and work-study received by the recipient to pay for tuition and materials are excluded in determination of eligibility for assistance under TANF or the amount of assistance received by the recipient

(c) The Department of Health and Social Services shall advise all persons of this section at application interviews and, at a minimum, at each recertification appointment.

(d) Persons attending education and training programs under this section shall receive support services, such as assistance with transportation and child care, while they attend the educational or vocational training program on the same basis as support services are provided other persons who are receiving assistance under TANF.

(e) If program completion will occur within one semester or quarter after the time limit expires, an extension may be granted for that semester or quarter.

(f) Persons sanctioned while attending educational or vocational programs shall be afforded the same due process as provided other persons under TANF.

**History**
- *14 DE Reg. 304 (10/01/10)*
- *25 DE Reg. 534 (11/01/21)*
- *25 DE Reg. 534 (11/01/21)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1370 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1235 (02/01/06)*
- *12 DE Reg. 793 (12/01/08)*
- *12 DE Reg. 793 (12/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/01/05)*
- *10 DE Reg. 706 (10/01/06)*
- *11 DE Reg. 1241 (03/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *9 DE Reg. 1372 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (05/01/05)*
- *9 DE Reg. 798 (11/01/05)*
- *Repealed 10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *9 DE Reg. 798 (11/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *9 DE Reg. 1978 (06/01/06)*
- *28 DE Reg. 673 (03/01/25)*
- *28 DE Reg. 673 (03/01/25)*
- *10 DE Reg. 706 (10/01/06)*
- *26 DE Reg. 964 (05/01/23)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg 773 (03/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *23 DE Reg. 63 (07/01/19)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *8 DE Reg. 1712 (06/01/05)*
- *10 DE Reg. 1700 (05/01/07)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1979 (06/01/06)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *8 DE Reg. 1024 (1/1/05)*
- *8 DE Reg. 1618 (5/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1024 (1/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *13 DE Reg. 1209 (03/01/10)*
- *16 DE Reg. 641 (12/01/12)*

##### **16 Del. Admin. Code § 3000-3007** TANF Supportive Services and Transitional Benefits {#sec-3000-3007 omnilex-key=us-de-regs-official--title-16--3000-3007}

3007.6 Transportation Assistance

Transportation assistance will be paid to participants who are referred to the TANF E&T Workfare Vendor to assist with the transportation costs incurred during the initial contact with the Workfare Vendor.

Participants residing in New Castle County will receive a $5.00 Transportation assistance check.

Participants residing in Kent and Sussex Counties will receive a $10.00 Transportation assistance check.

The Transportation checks will be sent automatically by DCIS II after Confirmation. Replacement checks can be issued by the supervisor after the completion of the affidavit.

**History**
- *14 DE Reg. 304 (10/01/10)*
- *25 DE Reg. 534 (11/01/21)*
- *25 DE Reg. 534 (11/01/21)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1370 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1235 (02/01/06)*
- *12 DE Reg. 793 (12/01/08)*
- *12 DE Reg. 793 (12/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/01/05)*
- *10 DE Reg. 706 (10/01/06)*
- *11 DE Reg. 1241 (03/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *9 DE Reg. 1372 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (05/01/05)*
- *9 DE Reg. 798 (11/01/05)*
- *Repealed 10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *9 DE Reg. 798 (11/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *9 DE Reg. 1978 (06/01/06)*
- *28 DE Reg. 673 (03/01/25)*
- *28 DE Reg. 673 (03/01/25)*
- *10 DE Reg. 706 (10/01/06)*
- *26 DE Reg. 964 (05/01/23)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg 773 (03/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *23 DE Reg. 63 (07/01/19)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *8 DE Reg. 1712 (06/01/05)*
- *10 DE Reg. 1700 (05/01/07)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1979 (06/01/06)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *8 DE Reg. 1024 (1/1/05)*
- *8 DE Reg. 1618 (5/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1024 (1/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *13 DE Reg. 1209 (03/01/10)*
- *16 DE Reg. 641 (12/01/12)*

##### **16 Del. Admin. Code § 3000-3008** Eligibility of Certain Minors {#sec-3000-3008 omnilex-key=us-de-regs-official--title-16--3000-3008}

3008.1.1 Babies Born To Teen Parents [Repealed]

3008.1.2 Three Generation Households [Repealed]

3008.1.3 Providing Non-cash Assistance:

3008.1.4 Minor Teen Parents

3008.2 Family Cap

Repealed, effective May 11, 2023

**History**
- *14 DE Reg. 304 (10/01/10)*
- *25 DE Reg. 534 (11/01/21)*
- *25 DE Reg. 534 (11/01/21)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1370 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1235 (02/01/06)*
- *12 DE Reg. 793 (12/01/08)*
- *12 DE Reg. 793 (12/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/01/05)*
- *10 DE Reg. 706 (10/01/06)*
- *11 DE Reg. 1241 (03/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *9 DE Reg. 1372 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (05/01/05)*
- *9 DE Reg. 798 (11/01/05)*
- *Repealed 10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *9 DE Reg. 798 (11/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *9 DE Reg. 1978 (06/01/06)*
- *28 DE Reg. 673 (03/01/25)*
- *28 DE Reg. 673 (03/01/25)*
- *10 DE Reg. 706 (10/01/06)*
- *26 DE Reg. 964 (05/01/23)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg 773 (03/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *23 DE Reg. 63 (07/01/19)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *8 DE Reg. 1712 (06/01/05)*
- *10 DE Reg. 1700 (05/01/07)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1979 (06/01/06)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *8 DE Reg. 1024 (1/1/05)*
- *8 DE Reg. 1618 (5/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1024 (1/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *13 DE Reg. 1209 (03/01/10)*
- *16 DE Reg. 641 (12/01/12)*

##### **16 Del. Admin. Code § 3000-3009** Defining the Contract of Mutual Responsibility {#sec-3000-3009 omnilex-key=us-de-regs-official--title-16--3000-3009}

The Contract of Mutual Responsibility (CMR) is an agreement between the TANF client and DSS which sets obligations and expectations for helping the client achieve self-sufficiency. The CMR is a requirement for all TANF clients.

1. All TANF clients are required to develop a CMR with their DSS case worker. The CMR outlines the requirements that the client must fulfill to receive TANF benefits.

A. The CMR encompasses three broad categories of requirements:

i. Self-sufficiency,

ii. Enhanced family functioning, and

iii. Teen responsibility.

B. The CMR is individualized to the specific needs and situations of each family.

C. The CMR will be revised as the needs and situations of the family evolve.

2. DSS case workers will assist clients in developing the CMR when TANF cases are opened and will monitor clients' compliance with the required CMR elements.

A. DSS case workers will:

i. Explain to clients the CMR requirements and the penalties for non-compliance.

ii. Give clients the appropriate time frame to comply with each CMR element. Compliance with the CMR elements is not required to initially apply for TANF.

iii. Review the CMR for compliance during TANF redeterminations or during reapplication if the TANF case closed for non-compliance with the CMR.

iv. Identify non-compliance with CMR elements and sanction TANF cases.

v. Address barriers that may impede clients' compliance with CMR elements.

3. DSS will sanction TANF cases when clients fail to comply with the CMR requirements.

A. Sanctions for non-compliance with the CMR are fiscal penalties that reduce or close TANF benefits.

B. The intended result of the sanction process is to motivate clients to cooperate.

C. DSS encourages clients to disclose any difficulties that may create barriers for meeting the CMR requirements. DSS will not impose a sanction if good cause exists.

D. A sanction will end when DSS receives proof that the TANF client is complying with the CMR requirements.

4. DSS will ensure that supportive services related to CMR requirements are available to TANF clients.

A. DSS will work with clients to identify barriers that may hinder compliance with the CMR requirements.

B. DSS will provide supportive services to clients to assist in reducing identified barriers.

C. DSS will not sanction clients if supportive services identified in the CMR are not available.

D. DSS will revise the CMR to reflect when a supportive service is not available to the client.

Related policies:

DSSM sections 3009, 3010, 3011, 3012, 3013, 3014, 3015, 3016, 3017

3009.1 Imposing Sanctions for Non-Compliance with CMR Requirements

DSS imposes sanctions on TANF cases when clients fail to comply with their CMR requirements. If DSS determines a client has good cause for non-compliance with the CMR, DSS will not sanction the TANF case.

1. DSS applies sanctions to a TANF case based on a penalty hierarchy for the three broad categories of CMR requirements: self-sufficiency, enhanced family functioning, and teen responsibility.

2. DSS case workers must follow the CMR sanctions penalty hierarchy as outlined in this policy. Case workers must apply sanctions that reduce benefits before applying sanctions that close the TANF case. Case workers must impose all CMR sanctions.

A. DSS applies teen responsibility sanctions first. The teen responsibility sanction removes a teen, age 16 and older, from the TANF case when the teen does not maintain satisfactory school or employment and training attendance.

B. DSS applies family functioning sanctions second. The family functioning sanction reduces the TANF benefit amount by $50 initially, with an additional reduction of $50 in the benefit amount each month the client is non-compliant with the CMR requirements for:

C. DSS applies self-sufficiency sanctions last. The self-sufficiency sanction closes the TANF case when the client is non-compliant with the CMR requirements for:

3. DSS removes sanctions from TANF cases when clients comply with their CMR requirements.

A. DSS case workers must verify that clients are compliant with their CMR requirements before the sanctions can end.

B. A sanction is removed from the TANF case on the date proof of compliance is provided to DSS.

3009.2 Sanctions Flow Chart

3009.3 Benefit Reduction for Multiple Sanction Types

Repealed.

**History**
- *14 DE Reg. 304 (10/01/10)*
- *25 DE Reg. 534 (11/01/21)*
- *25 DE Reg. 534 (11/01/21)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1370 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1235 (02/01/06)*
- *12 DE Reg. 793 (12/01/08)*
- *12 DE Reg. 793 (12/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/01/05)*
- *10 DE Reg. 706 (10/01/06)*
- *11 DE Reg. 1241 (03/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *9 DE Reg. 1372 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (05/01/05)*
- *9 DE Reg. 798 (11/01/05)*
- *Repealed 10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *9 DE Reg. 798 (11/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *9 DE Reg. 1978 (06/01/06)*
- *28 DE Reg. 673 (03/01/25)*
- *28 DE Reg. 673 (03/01/25)*
- *10 DE Reg. 706 (10/01/06)*
- *26 DE Reg. 964 (05/01/23)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg 773 (03/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *23 DE Reg. 63 (07/01/19)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *8 DE Reg. 1712 (06/01/05)*
- *10 DE Reg. 1700 (05/01/07)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1979 (06/01/06)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *8 DE Reg. 1024 (1/1/05)*
- *8 DE Reg. 1618 (5/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1024 (1/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *13 DE Reg. 1209 (03/01/10)*
- *16 DE Reg. 641 (12/01/12)*

##### **16 Del. Admin. Code § 3000-3010** Requiring Participation and Cooperation in Developing the CMR {#sec-3000-3010 omnilex-key=us-de-regs-official--title-16--3000-3010}

Participating and cooperating with DSS in developing the CMR is a required CMR element for all TANF clients.

1. TANF clients are required to develop a CMR in collaboration with their DSS case workers. Compliance with developing the CMR applies to all TANF cases.

2. DSS case workers will discuss the CMR elements with clients and assist clients in developing and customizing the CMR.

A. DSS will give clients the opportunity to mutually develop their CMRs.

B. CMRs will include requirements for self-sufficiency, enhanced family planning, and teen responsibility.

C. Prior to signing the CMR, DSS will give clients the opportunity to understand the CMR and its requirements. Upon request, DSS will give clients a copy of the proposed CMR to review outside of the DSS office; this should not be considered non-cooperation.

D. Clients may object to certain elements of the CMR. Clients are to present any objections at the time of the initial CMR development or CMR revision.

E. On a case by case basis, DSS may waive elements of the CMR if good cause exists. If the particular circumstances of a family warrant waiving an element of the CMR, the case worker must justify and properly document the waiver in the client’s case record.

F. DSS has the final determination of what elements are required in each client’s CMR.

3. Failure to comply (without good cause) in developing the CMR will result in a sanction to the TANF case.

A. The sanction will be an initial $50.00 reduction in the household’s TANF benefit amount.

i. If the client is actively negotiating the terms of the CMR or reviewing the CMR outside of the DSS office, DSS will not impose the $50.00 penalty. DSS must allow clients up to 10 days to reach a resolution or to complete contract review.

ii. DSS will consider clients who have not returned their CMRs within 10 days as non-compliant and subject to the $50.00 penalty.

B. This reduction increases each month by $50.00 until there is compliance or the TANF case is closed.

C. The client will receive written notification of compliance requirements.

D. The sanction will end when DSS receives proof that the client completed the development of the CMR.

3010.1 Penalties for Not Cooperating in Development of CMR

Repealed.

3010.2 Contract of Mutual Responsibility and Domestic Violence Screenings

3010.2.1 Family Development Profile

The Family Development Profile is an assessment tool used to identify possible social, family and emotional barriers to self-sufficiency as they affect an individual’s ability to obtain and retain employment. The Family Development Profile covers issues of self-esteem, health and family relationships. This tool is designed to surface those issues which, when resolved, will increase the participant’s ability to become truly self-sufficient. This assessment tool is a mandatory assessment tool for all adult and teen TANF recipients.

3010.2.2 Domestic Violence

One of the issues which may pose a challenge to individuals and families becoming self-sufficient is domestic violence. Domestic violence is a pattern of abusive behavior that happens between two people in an adult relationship. Stress, family history of abuse, drug use and alcohol use may be contributing factors in a domestic violence situation.

Delaware is committed to assisting victims of domestic violence to overcome circumstances which place them in physical, emotional and/or financial jeopardy. This assistance includes aiding the victims in seeking redress and a safe environment for their families. Additionally, on a case-by-case basis, Contract of Mutual Responsibility requirements may be waived if it is determined that by complying with the requirements it would be more difficult for the individual and the family to escape and/or remain safe from the violence. This determination will be made in conjunction with input and information from the domestic violence victim.

3010.2.3 Definition

Domestic violence occurs when one spouse, domestic partner or significant other tries to maintain power and control over the other person. The perpetrator of the violence may use physical, verbal or sexual violence to maintain power and control over the victim. Although domestic violence can happen to anyone, most victims are women. Therefore, we will use feminine pronouns.

The following acts perpetrated by a current or former intimate partner, relative or household member shall be considered to be domestic violence:

A partner who constantly calls or shows up at his partners job to interfere with her work.

3010.2.4 Domestic Violence Determination

DSS shall consider any evidence that is relevant to the domestic violence claim. This is to include a victim’s significantly reduced capacity to care for herself or her child, or significantly reduced capacity to perform essential activities of daily living.

DSS shall determine what evidence is credible and the weight to be given to that evidence. Evidence can be, but is not limited to:

3010.2.5 CMR Requirements

3010.2.6 Children's Program

**History**
- *14 DE Reg. 304 (10/01/10)*
- *25 DE Reg. 534 (11/01/21)*
- *25 DE Reg. 534 (11/01/21)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1370 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1235 (02/01/06)*
- *12 DE Reg. 793 (12/01/08)*
- *12 DE Reg. 793 (12/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/01/05)*
- *10 DE Reg. 706 (10/01/06)*
- *11 DE Reg. 1241 (03/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *9 DE Reg. 1372 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (05/01/05)*
- *9 DE Reg. 798 (11/01/05)*
- *Repealed 10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *9 DE Reg. 798 (11/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *9 DE Reg. 1978 (06/01/06)*
- *28 DE Reg. 673 (03/01/25)*
- *28 DE Reg. 673 (03/01/25)*
- *10 DE Reg. 706 (10/01/06)*
- *26 DE Reg. 964 (05/01/23)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg 773 (03/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *23 DE Reg. 63 (07/01/19)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *8 DE Reg. 1712 (06/01/05)*
- *10 DE Reg. 1700 (05/01/07)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1979 (06/01/06)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *8 DE Reg. 1024 (1/1/05)*
- *8 DE Reg. 1618 (5/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1024 (1/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *13 DE Reg. 1209 (03/01/10)*
- *16 DE Reg. 641 (12/01/12)*

##### **16 Del. Admin. Code § 3000-3011** Requiring Employment and Training Participation {#sec-3000-3011 omnilex-key=us-de-regs-official--title-16--3000-3011}

3011.1 Employment and Training Requirements

Clients must keep appointments with employment and training staff, cooperate in the development of the Employability Plan, and participate in employment and training activities equivalent to the required weekly amounts.

Clients who have secured employment are expected to continue employment unless they have good cause for terminating a job (see Good Cause definition under 3001 Definitions) and participate in approved employment and training activities.

Parents are expected to cooperate with school officials and other service providers in helping their child(ren) maintain satisfactory attendance. Penalties can be imposed if parents do not cooperate. Parents with children under age 16 are expected to exert more influence over their children since early school attendance is so important in moving children down the path to self-sufficiency. (See section DSSM 3009 and 3012 for requirements and sanctions related to cooperation to ensure school attendance by children 16 and over and children under the age of 16.

3011.2 Sanctioning For Not Meeting Employment and Training Requirements

This policy applies to cases in which one or more parents are required to participate in TANF employment and training activities.

1. The TANF Case Is Sanctioned When A Parent Does Not Complete Their Required Hours.

Each week clients are required to engage in and verify their participation in assigned employment and training activities. The TANF case is sanctioned when a client does not complete the required hours or does not submit the required verification of their hours for any week. The sanction known as a Full Family Sanction or Self-sufficiency Sanction is closure of the TANF case until the sanction is cured or the parent becomes exempt from employment and training requirements.

2. The TANF Case Is Sanctioned When A Needy Non-Parent Caretaker Does Not Complete Their Hours.

Each week clients are required to engage in and verify their participation in assigned employment and activities. The TANF case is sanctioned when a needy non-parent caretaker does not complete the required hours or does not submit the required verification of their hours for any week. The sanction is removal of the caretaker from the grant until the sanction is cured or the caretaker becomes exempt from employment and training requirements.

3011.2.1 Sanctioning When Child Care Is Not Available

This policy applies to TANF cases with a single custodial parent caring for a child under age six and the parent is required to participate in TANF employment and training activities.

1. A Parent Who Is Unable To Obtain Child Care Is Not Sanctioned

A Full Family Sanction is not applied to a TANF case when the parent demonstrates that child care is not available.

2. A Parent Must Demonstrate Child Care Is Not Available.

Credible evidence of any one of the following conditions demonstrates that child care is not available.

a. Appropriate child care is unavailable within a reasonable distance from their home or work. Reasonable distance is defined as care that is located in proximity to either a parent’s place of employment or the parent’s home; generally care that is within ten (10) miles of either the home or work.

b. Informal child care by a relative or under other arrangements is unavailable or unsuitable. Informal care is considered unsuitable if the care would not meet the physical or psychological needs of the child.

c. An appropriate and affordable formal child care arrangement is not available.

Affordable care is defined as care that would provide access to a full range of child care categories and types of providers; appropriate care is care that meets the health and safety standards as defined by State licensing guidelines, as well as the needs of the parent and child.

3. A Parent Must Report That Child Care Is Not Available Within Ten (10) Days.

Parents who claim an inability to obtain needed child care must contact a DSS worker to press their claim. Parents have ten (10) days, either from the date when they first attempted to find child care or ten (10) days from the date DSS instructed them to participate in work activities.

4. DSS Will Decide On A Parent’s Claim Of Child Care Unavailability Within Twenty (20) Days.

DSS staff have twenty (20) days to review and decide whether the parent’s claim that child care is not available is legitimate. If DSS determines that the parents did not demonstrate their claim, DSS will impose applicable sanctions if the family has not met the employment and training requirement. DSS workers will document in the client’s record the client’s claim and their legitimacy determination.

5. Families Are Not Exempt From Time Limits

While a parent may not be sanctioned as a result of child care being unavailable, the parent is not exempt from the TANF time limits.

3011.3 Curing a Full Family Sanction

This policy applies to TANF cases that have been sanctioned as a result of not meeting the TANF requirements for employment and training.

1. Mandatory Employment And Training Participants Must Work With An Assigned Vendor.

To cure the sanction clients must work with an assigned employment and training vendor. The vendor will develop a plan with the client that specifies the weekly activities and hours the client must complete to be in compliance with the TANF program. Based on family composition clients are generally required to complete twenty (20), thirty (30), or forty (40) hours per week of approved activities.

2. Clients Must Complete Four (4) Consecutive Weeks Of Participation.

To cure the Full Family Sanction clients must complete and submit required verification of their required activities and hours to the employment and training vendor. They must complete four (4) consecutive weeks of full participation.

For the TANF program purposes a week is a seven (7) day period which begins on Monday and ends on Sunday.

3. The TANF Case Reopens At The Beginning Of The Four (4) Week Cure Period.

When the TANF family has remained technically and financially eligible for TANF during the cure sanction period, once the requirement of four (4) consecutive weeks of full and verified participation has been completed the TANF case will reopen effective the first day of the four (4) week cure sanction period.

**History**
- *14 DE Reg. 304 (10/01/10)*
- *25 DE Reg. 534 (11/01/21)*
- *25 DE Reg. 534 (11/01/21)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1370 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1235 (02/01/06)*
- *12 DE Reg. 793 (12/01/08)*
- *12 DE Reg. 793 (12/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/01/05)*
- *10 DE Reg. 706 (10/01/06)*
- *11 DE Reg. 1241 (03/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *9 DE Reg. 1372 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (05/01/05)*
- *9 DE Reg. 798 (11/01/05)*
- *Repealed 10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *9 DE Reg. 798 (11/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *9 DE Reg. 1978 (06/01/06)*
- *28 DE Reg. 673 (03/01/25)*
- *28 DE Reg. 673 (03/01/25)*
- *10 DE Reg. 706 (10/01/06)*
- *26 DE Reg. 964 (05/01/23)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg 773 (03/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *23 DE Reg. 63 (07/01/19)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *8 DE Reg. 1712 (06/01/05)*
- *10 DE Reg. 1700 (05/01/07)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1979 (06/01/06)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *8 DE Reg. 1024 (1/1/05)*
- *8 DE Reg. 1618 (5/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1024 (1/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *13 DE Reg. 1209 (03/01/10)*
- *16 DE Reg. 641 (12/01/12)*

##### **16 Del. Admin. Code § 3000-3012** Requiring Satisfactory School Attendance {#sec-3000-3012 omnilex-key=us-de-regs-official--title-16--3000-3012}

Ensuring TANF children maintain satisfactory school attendance is a required CMR element for all TANF clients.

1. School attendance requirements exist for both TANF adults and children.

A. TANF adults are required to cooperate with school officials and other service providers when necessary to help their children maintain satisfactory school attendance.

B. TANF children are required to maintain satisfactory school attendance as defined by their individual schools or at an 85% attendance rate.

2. TANF clients will receive one-time bonus payments when their children achieve specific school milestones.

A. DSS will issue a one-time bonus payment for TANF children who graduate from high school by age 19. This bonus payment will be paid directly to the high school graduate.

B. DSS case workers must disregard the bonus payment as income for TANF and Food Benefit cases.

3. Failure to comply (without good cause) with the school attendance element in the CMR will result in a sanction to the TANF case.

A. For children under 16 years old:

i. The sanction will be an initial $50.00 reduction in the household’s TANF benefit amount if

the TANF adult does not comply with the school or other service providers to ensure the

child’s satisfactory school attendance.

ii. This reduction increases each month by $50.00 until there is compliance or the TANF

case is closed.

iii. If the child does not comply, a sanction will not be imposed if the TANF adult is complying

with the school or other service providers.

B. For children over 16 years old:

i. If the child does not comply, the child is removed from the TANF grant and the household

size is reduced.

C. The client will receive written notification of compliance requirements.

D. The sanction will end when DSS receives proof that TANF clients are complying with the school

attendance element.

i. The TANF adult must comply with the school or other service providers for four consecutive weeks for the sanction to end.

ii. TANF children over 16 years old must return to school, participate in employment and training, or work for four consecutive weeks for the sanction to end.

3012.1 Sanctions and Cures for Unsatisfactory School Attendance

Repealed, effective November 12, 2019.

3012.2 Curing Sanction Penalties

Repealed.

**History**
- *14 DE Reg. 304 (10/01/10)*
- *25 DE Reg. 534 (11/01/21)*
- *25 DE Reg. 534 (11/01/21)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1370 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1235 (02/01/06)*
- *12 DE Reg. 793 (12/01/08)*
- *12 DE Reg. 793 (12/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/01/05)*
- *10 DE Reg. 706 (10/01/06)*
- *11 DE Reg. 1241 (03/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *9 DE Reg. 1372 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (05/01/05)*
- *9 DE Reg. 798 (11/01/05)*
- *Repealed 10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *9 DE Reg. 798 (11/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *9 DE Reg. 1978 (06/01/06)*
- *28 DE Reg. 673 (03/01/25)*
- *28 DE Reg. 673 (03/01/25)*
- *10 DE Reg. 706 (10/01/06)*
- *26 DE Reg. 964 (05/01/23)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg 773 (03/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *23 DE Reg. 63 (07/01/19)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *8 DE Reg. 1712 (06/01/05)*
- *10 DE Reg. 1700 (05/01/07)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1979 (06/01/06)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *8 DE Reg. 1024 (1/1/05)*
- *8 DE Reg. 1618 (5/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1024 (1/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *13 DE Reg. 1209 (03/01/10)*
- *16 DE Reg. 641 (12/01/12)*

##### **16 Del. Admin. Code § 3000-3013** Requiring Immunizations {#sec-3000-3013 omnilex-key=us-de-regs-official--title-16--3000-3013}

Maintaining current immunizations for TANF children is a required CMR element for all TANF clients.

1. TANF children are required to be immunized based on their physicians' immunization schedules.

2. DSS case workers shall verify that TANF children are current on their immunizations.

3. Failure to comply (without good cause) with the immunization element in the CMR will result in a sanction to the TANF case.

A. The sanction will be an initial $50.00 reduction in the household's TANF benefit amount.

B. This reduction increases each month by $50.00 until there is compliance or the TANF case is closed.

C. The client will receive written notification of compliance requirements.

D. The sanction will end when DSS receives proof that the immunization schedule sequence has begun for all TANF children in the case.

3013.1 Sanctions for Not Meeting Immunization Requirements

Repealed.

3013.2 Curing Sanction Penalties

Repealed.

**History**
- *14 DE Reg. 304 (10/01/10)*
- *25 DE Reg. 534 (11/01/21)*
- *25 DE Reg. 534 (11/01/21)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1370 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1235 (02/01/06)*
- *12 DE Reg. 793 (12/01/08)*
- *12 DE Reg. 793 (12/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/01/05)*
- *10 DE Reg. 706 (10/01/06)*
- *11 DE Reg. 1241 (03/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *9 DE Reg. 1372 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (05/01/05)*
- *9 DE Reg. 798 (11/01/05)*
- *Repealed 10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *9 DE Reg. 798 (11/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *9 DE Reg. 1978 (06/01/06)*
- *28 DE Reg. 673 (03/01/25)*
- *28 DE Reg. 673 (03/01/25)*
- *10 DE Reg. 706 (10/01/06)*
- *26 DE Reg. 964 (05/01/23)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg 773 (03/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *23 DE Reg. 63 (07/01/19)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *8 DE Reg. 1712 (06/01/05)*
- *10 DE Reg. 1700 (05/01/07)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1979 (06/01/06)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *8 DE Reg. 1024 (1/1/05)*
- *8 DE Reg. 1618 (5/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1024 (1/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *13 DE Reg. 1209 (03/01/10)*
- *16 DE Reg. 641 (12/01/12)*

##### **16 Del. Admin. Code § 3000-3014** Requiring Family Planning {#sec-3000-3014 omnilex-key=us-de-regs-official--title-16--3000-3014}

Obtaining family planning information is a required CMR element for all TANF adults and minor parents.

1. TANF adults and minor parents are required to obtain family planning information from the provider of their choice.

2. DSS case workers shall verify that TANF adults and minor parents obtain family planning information, but not that a particular method is being used. If family planning is not used and the birth of a baby is the result, the family cap provision will apply.

3. Failure to comply (without good cause) with the family planning element in the CMR will result in a sanction to the TANF case.

A. The sanction will be an initial $50.00 reduction in the household's TANF benefit amount.

B. This reduction increases each month by $50.00 until there is compliance or the TANF case is closed.

C. The client will receive written notification of compliance requirements.

D. The sanction will end when DSS receives proof that the TANF adults and any minor parents in the case obtained family planning information.

Related policies:

DSSM 3008.2

3014.1 Sanctions for Not Meeting Family Planning Requirements

Repealed.

3014.2 Curing Family Planning Sanction Penalties

Repealed.

**History**
- *14 DE Reg. 304 (10/01/10)*
- *25 DE Reg. 534 (11/01/21)*
- *25 DE Reg. 534 (11/01/21)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1370 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1235 (02/01/06)*
- *12 DE Reg. 793 (12/01/08)*
- *12 DE Reg. 793 (12/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/01/05)*
- *10 DE Reg. 706 (10/01/06)*
- *11 DE Reg. 1241 (03/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *9 DE Reg. 1372 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (05/01/05)*
- *9 DE Reg. 798 (11/01/05)*
- *Repealed 10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *9 DE Reg. 798 (11/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *9 DE Reg. 1978 (06/01/06)*
- *28 DE Reg. 673 (03/01/25)*
- *28 DE Reg. 673 (03/01/25)*
- *10 DE Reg. 706 (10/01/06)*
- *26 DE Reg. 964 (05/01/23)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg 773 (03/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *23 DE Reg. 63 (07/01/19)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *8 DE Reg. 1712 (06/01/05)*
- *10 DE Reg. 1700 (05/01/07)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1979 (06/01/06)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *8 DE Reg. 1024 (1/1/05)*
- *8 DE Reg. 1618 (5/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1024 (1/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *13 DE Reg. 1209 (03/01/10)*
- *16 DE Reg. 641 (12/01/12)*

##### **16 Del. Admin. Code § 3000-3015** Requiring Parenting Education {#sec-3000-3015 omnilex-key=us-de-regs-official--title-16--3000-3015}

Completing parenting education classes is a required CMR element for all TANF adults and minor parents.

1. TANF adults and minor parents are required to complete DSS approved parenting education classes. Once the client completes this element, it does not have to be repeated.

2. DSS case workers shall verify that TANF adults and minor parents complete parenting education classes.

3. Failure to comply (without good cause) with the parenting education element in the CMR will result in a sanction to the TANF case.

A. The sanction will be an initial $50.00 reduction in the household's TANF benefit amount.

B. This reduction increases each month by $50.00 until there is compliance or the TANF case is closed.

C. The client will receive written notification of compliance requirements.

attended parenting education classes.

3015.1 Sanctions for Not Meeting Parenting Education Requirements

Repealed.

3015.2 Curing Parenting Education Sanction Penalties

Repealed.

**History**
- *14 DE Reg. 304 (10/01/10)*
- *25 DE Reg. 534 (11/01/21)*
- *25 DE Reg. 534 (11/01/21)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1370 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1235 (02/01/06)*
- *12 DE Reg. 793 (12/01/08)*
- *12 DE Reg. 793 (12/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/01/05)*
- *10 DE Reg. 706 (10/01/06)*
- *11 DE Reg. 1241 (03/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *9 DE Reg. 1372 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (05/01/05)*
- *9 DE Reg. 798 (11/01/05)*
- *Repealed 10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *9 DE Reg. 798 (11/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *9 DE Reg. 1978 (06/01/06)*
- *28 DE Reg. 673 (03/01/25)*
- *28 DE Reg. 673 (03/01/25)*
- *10 DE Reg. 706 (10/01/06)*
- *26 DE Reg. 964 (05/01/23)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg 773 (03/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *23 DE Reg. 63 (07/01/19)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *8 DE Reg. 1712 (06/01/05)*
- *10 DE Reg. 1700 (05/01/07)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1979 (06/01/06)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *8 DE Reg. 1024 (1/1/05)*
- *8 DE Reg. 1618 (5/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1024 (1/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *13 DE Reg. 1209 (03/01/10)*
- *16 DE Reg. 641 (12/01/12)*

##### **16 Del. Admin. Code § 3000-3016** Defining the Bridge Program {#sec-3000-3016 omnilex-key=us-de-regs-official--title-16--3000-3016}

The Bridge Program provides services to TANF clients who are experiencing barriers to self-sufficiency.

1. The Bridge Program is a resource for TANF clients to address barriers such as substance abuse, mental health issues, domestic violence, and homelessness.

A. The Bridge Program provides clients with specialized screening, intensive case management,

and assistance with accessing services and treatment for identified barriers.

B. Bridge Program services support clients in meeting their employment goals, reducing or

eliminating barriers to self-sufficiency, and promoting family stability.

2. Referrals for TANF clients to the Bridge Program may be initiated by DSS staff, TANF employment and training vendors, the Bridge Program vendor, or a client self-referral.

A. DSS case workers will complete the Family Development Profile screening instrument with

TANF clients at intake and redetermination to identify potential barriers.

B. DSS case workers may refer TANF clients to the Bridge Program when:

i. A potential barrier is identified by the Family Development Profile;

ii. The DSS case worker suspects barriers exist during any client contact; or

iii. A client discloses the need for assistance with a barrier.

3. The Bridge Program vendor will outreach and screen referred TANF clients and will refer clients for additional services when appropriate.

4. Bridge Program services may be added as a required CMR element for TANF clients who have barriers that cause significant difficulty in complying with the TANF program requirements.

5. Bridge Program activities count toward the required employment and training participation hours for TANF clients.

3016.1 Requiring Bridge Program Services

42 USC 608 (b)(2)(A)(v)

Complying with Bridge Program services may be a required CMR element for TANF clients who may have substance abuse issues.

1. TANF clients who may have substance abuse issues may be required to comply with the Bridge

Program.

A. DSS case workers may add the Bridge Program element to a TANF client’s CMR when:

i. A substance abuse issue is identified by the client’s Family Development Profile;

ii. The potential substance abuse barrier is impeding the client’s employment goals, self-sufficiency, or family stabilization; and

iii. The client has refused to voluntarily participate with the Bridge Program.

B. The Bridge Program vendor will complete a specialized screening with the TANF client and

may refer the client to receive an assessment from a licensed treatment provider.

C. Once an assessment has been completed, the TANF client will work with DSS and the TANF

vendor partners to determine if additional Bridge Program services will be a required CMR

element.

2. The Bridge Program vendor will monitor and document TANF clients’ Bridge participation for DSS

and the TANF employment and training vendors.

3. Failure to comply (without good cause) with the Bridge Program element in the CMR will result in a

sanction to the TANF case.

A. The sanction will be an initial $50.00 reduction in the household’s TANF benefit amount.

B. This reduction increases each month by $50.00 until there is compliance or the TANF case is

closed.

C. The client will receive written notification of compliance requirements.

D. The sanction will end when DSS receives proof that the TANF client is complying with Bridge

Program services.

3016.2 Curing Substance Abuse Sanction Penalties

Repealed.

**History**
- *14 DE Reg. 304 (10/01/10)*
- *25 DE Reg. 534 (11/01/21)*
- *25 DE Reg. 534 (11/01/21)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1370 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1235 (02/01/06)*
- *12 DE Reg. 793 (12/01/08)*
- *12 DE Reg. 793 (12/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/01/05)*
- *10 DE Reg. 706 (10/01/06)*
- *11 DE Reg. 1241 (03/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *9 DE Reg. 1372 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (05/01/05)*
- *9 DE Reg. 798 (11/01/05)*
- *Repealed 10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *9 DE Reg. 798 (11/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *9 DE Reg. 1978 (06/01/06)*
- *28 DE Reg. 673 (03/01/25)*
- *28 DE Reg. 673 (03/01/25)*
- *10 DE Reg. 706 (10/01/06)*
- *26 DE Reg. 964 (05/01/23)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg 773 (03/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *23 DE Reg. 63 (07/01/19)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *8 DE Reg. 1712 (06/01/05)*
- *10 DE Reg. 1700 (05/01/07)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1979 (06/01/06)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *8 DE Reg. 1024 (1/1/05)*
- *8 DE Reg. 1618 (5/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1024 (1/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *13 DE Reg. 1209 (03/01/10)*
- *16 DE Reg. 641 (12/01/12)*

##### **16 Del. Admin. Code § 3000-3017** Establishing Additional Contract of Mutual Responsibility Elements {#sec-3000-3017 omnilex-key=us-de-regs-official--title-16--3000-3017}

This policy applies when additional Contract of Mutual Responsibility (CMR) elements are identified and added to a TANF client's CMR.

1. Additional CMR elements refer to other services that may aid in self-sufficiency and are specified in a client's CMR.

2. DSS, the family, or other agencies that are involved with the family may identify additional CMR elements.

3. Failure to comply (without good cause) with the DSS identified elements in the CMR will result in a sanction to the TANF case.

A. The sanction will be an initial $50.00 reduction in the household's TANF benefit amount.

B. This reduction increases each month by $50.00 until there is compliance or the TANF case is closed.

C. The client will receive written notification of compliance requirements.

D. The sanction will end when DSS receives proof that the TANF client has met the compliance requirements.

3017.1 Participating in the Transitional Work Program

All TANF E&T exempt clients are eligible for referral to the Transitional Work Program (TWP). Participating in TWP

is a required CMR element for all clients who are referred to the program.

1. TWP provides assessment and case management services to TANF E&T exempt clients who have been determined unable to work in an unsubsidized employment setting by a health professional.

2. TWP offers services to:

3 . All clients who are referred to TWP are required to participate in the program. Clients are not expected to participate beyond the maximum limits established by a health professional.

4. The CMR and the TWP Employability Plan establish time limits for the completion of TWP activities and goals.

5. Failure to comply (without good cause) with the TWP element in the CMR will result in a sanction to the TANF case.

A. The sanction will be an initial $50.00 reduction in the household’s TANF benefit amount.

B. This reduction increases each month by $50.00 until there is compliance or the TANF case is closed.

C. The client will receive written notification of compliance requirements.

D. The sanction will end when DSS receives proof that the TANF client is actively participating with TWP.

3017.1.1 Sanctions for Not Meeting the TWP Requirements

Repealed.

3017.1.2 Curing TWP Sanctions

Repealed.

3017.2 Requiring Financial Coaching Orientation

Completing financial coaching orientation is a required CMR element for all work mandatory TANF clients.

1. Work mandatory TANF clients are required to complete a DSS approved financial coaching orientation.

A. The orientation informs TANF clients of available free financial coaching services.

B. Once the client completes this element, it does not have to be repeated.

2. DSS case workers shall verify that work mandatory TANF clients complete the financial coaching orientation.

3. Failure to comply (without good cause) with the financial coaching orientation element in the CMR will result in a sanction to the TANF case.

A. The sanction will be an initial $50.00 reduction in the household's TANF benefit amount.

B. This reduction increases each month by $50.00 until there is compliance or the TANF case is closed.

C. The client will receive written notification of compliance requirements.

D. The sanction will end when DSS receives proof that the TANF client completed the financial coaching

orientation.

3017.2.1 Sanctions for Not Meeting Division of Social Services Identified CMR Elements

Repealed.

3017.2.2 Curing Division of Social Services Identified CMR Sanction Penalties

Repealed.

**History**
- *14 DE Reg. 304 (10/01/10)*
- *25 DE Reg. 534 (11/01/21)*
- *25 DE Reg. 534 (11/01/21)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1370 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1235 (02/01/06)*
- *12 DE Reg. 793 (12/01/08)*
- *12 DE Reg. 793 (12/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/01/05)*
- *10 DE Reg. 706 (10/01/06)*
- *11 DE Reg. 1241 (03/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *9 DE Reg. 1372 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (05/01/05)*
- *9 DE Reg. 798 (11/01/05)*
- *Repealed 10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *9 DE Reg. 798 (11/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *9 DE Reg. 1978 (06/01/06)*
- *28 DE Reg. 673 (03/01/25)*
- *28 DE Reg. 673 (03/01/25)*
- *10 DE Reg. 706 (10/01/06)*
- *26 DE Reg. 964 (05/01/23)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg 773 (03/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *23 DE Reg. 63 (07/01/19)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *8 DE Reg. 1712 (06/01/05)*
- *10 DE Reg. 1700 (05/01/07)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1979 (06/01/06)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *8 DE Reg. 1024 (1/1/05)*
- *8 DE Reg. 1618 (5/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1024 (1/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *13 DE Reg. 1209 (03/01/10)*
- *16 DE Reg. 641 (12/01/12)*

##### **16 Del. Admin. Code § 3000-3018** General Assistance (GA) {#sec-3000-3018 omnilex-key=us-de-regs-official--title-16--3000-3018}

General Assistance is a State funded cash assistance program available to families and unemployable individuals who meet the financial eligibility requirements of the program and who are ineligible for TANF and SSI with the following exception:

A child's caretaker, who is otherwise eligible for GA and who is not the child's parent, may choose to receive GA instead of TANF.

EXAMPLE: A woman with no income is unemployable and is the caretaker of a seven year old niece. The woman may choose to receive GA for herself and be payee only for the TANF grant for her niece, or she may be included in the TANF unit with her niece.

Married or unmarried couples living with their children as a family unit that are not eligible for TANF or TANF-UP are technically eligible for GA.

EXAMPLE: A couple lives with their children as a unit. Both parents are healthy and unemployed. Neither parent meets work quarter requirements for TANF-UP. The family is technically eligible to receive GA.

3018.1 GA and SSI Recipients

**History**
- *14 DE Reg. 304 (10/01/10)*
- *25 DE Reg. 534 (11/01/21)*
- *25 DE Reg. 534 (11/01/21)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1370 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1235 (02/01/06)*
- *12 DE Reg. 793 (12/01/08)*
- *12 DE Reg. 793 (12/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/01/05)*
- *10 DE Reg. 706 (10/01/06)*
- *11 DE Reg. 1241 (03/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *9 DE Reg. 1372 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (05/01/05)*
- *9 DE Reg. 798 (11/01/05)*
- *Repealed 10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *9 DE Reg. 798 (11/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *9 DE Reg. 1978 (06/01/06)*
- *28 DE Reg. 673 (03/01/25)*
- *28 DE Reg. 673 (03/01/25)*
- *10 DE Reg. 706 (10/01/06)*
- *26 DE Reg. 964 (05/01/23)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg 773 (03/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *23 DE Reg. 63 (07/01/19)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *8 DE Reg. 1712 (06/01/05)*
- *10 DE Reg. 1700 (05/01/07)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1979 (06/01/06)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *8 DE Reg. 1024 (1/1/05)*
- *8 DE Reg. 1618 (5/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1024 (1/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *13 DE Reg. 1209 (03/01/10)*
- *16 DE Reg. 641 (12/01/12)*

##### **16 Del. Admin. Code § 3000-3019** Definitions of Unemployable {#sec-3000-3019 omnilex-key=us-de-regs-official--title-16--3000-3019}

An adult is unemployable and therefore technically eligible for GA when the adult is:

1. Ill or incapacitated, and unable to perform work activities. The nature of the individual's health problem, its expected duration, and the individual's inability to perform work activities must be verified in the case record. The eligibility of temporarily incapacitated persons must be redetermined at the end of the period of incapacity specified by the physician.

Note: GA may be authorized or continued for a period not to exceed 90 days to an incapacitated person who is hospitalized.

An individual whose incapacity is expected to last more than 12 months is referred to the Social Security Administration.

2. For a period not to exceed two (2) months, a person whose SSI disability or SSA disability benefits have ended and who is appealing the decision. Verification of the appeal to the SSA is required. The individual's eligibility must be redetermined at the end of the two‑ month period. GA benefits can continue only if another condition of unemployability is established.

3. Needed at home to care for another household member who is ill or incapacitated. Verification that another person is needed at home to care for the incapacitated individual is required.

4. Needed at home to care for a child under age six because there is no other person able to care for the child. The child's age and presence in the home must be verified.

5. Age 55 or over. Age must be verified.

6. For a period not to exceed two years, a high school student who attends school at least 15 hours per week and whose educational needs render him/her unavailable for regular employment. The individual must be able to complete his/her schooling within two years of the application filing date. Students must maintain satisfactory school attendance while receiving General Assistance. School enrollment, attendance, and the anticipated date of graduation must be verified. High school status also includes students enrolled in a high school equivalency program.

**History**
- *14 DE Reg. 304 (10/01/10)*
- *25 DE Reg. 534 (11/01/21)*
- *25 DE Reg. 534 (11/01/21)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1370 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1235 (02/01/06)*
- *12 DE Reg. 793 (12/01/08)*
- *12 DE Reg. 793 (12/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/01/05)*
- *10 DE Reg. 706 (10/01/06)*
- *11 DE Reg. 1241 (03/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *9 DE Reg. 1372 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (05/01/05)*
- *9 DE Reg. 798 (11/01/05)*
- *Repealed 10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *9 DE Reg. 798 (11/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *9 DE Reg. 1978 (06/01/06)*
- *28 DE Reg. 673 (03/01/25)*
- *28 DE Reg. 673 (03/01/25)*
- *10 DE Reg. 706 (10/01/06)*
- *26 DE Reg. 964 (05/01/23)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg 773 (03/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *23 DE Reg. 63 (07/01/19)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *8 DE Reg. 1712 (06/01/05)*
- *10 DE Reg. 1700 (05/01/07)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1979 (06/01/06)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *8 DE Reg. 1024 (1/1/05)*
- *8 DE Reg. 1618 (5/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1024 (1/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *13 DE Reg. 1209 (03/01/10)*
- *16 DE Reg. 641 (12/01/12)*

##### **16 Del. Admin. Code § 3000-3020** Employable Adults {#sec-3000-3020 omnilex-key=us-de-regs-official--title-16--3000-3020}

Adults, aged 18‑ 54, are not eligible for General Assistance if they are:

1. employable; and

2. have no children in their care.

**History**
- *14 DE Reg. 304 (10/01/10)*
- *25 DE Reg. 534 (11/01/21)*
- *25 DE Reg. 534 (11/01/21)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1370 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1235 (02/01/06)*
- *12 DE Reg. 793 (12/01/08)*
- *12 DE Reg. 793 (12/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/01/05)*
- *10 DE Reg. 706 (10/01/06)*
- *11 DE Reg. 1241 (03/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *9 DE Reg. 1372 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (05/01/05)*
- *9 DE Reg. 798 (11/01/05)*
- *Repealed 10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *9 DE Reg. 798 (11/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *9 DE Reg. 1978 (06/01/06)*
- *28 DE Reg. 673 (03/01/25)*
- *28 DE Reg. 673 (03/01/25)*
- *10 DE Reg. 706 (10/01/06)*
- *26 DE Reg. 964 (05/01/23)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg 773 (03/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *23 DE Reg. 63 (07/01/19)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *8 DE Reg. 1712 (06/01/05)*
- *10 DE Reg. 1700 (05/01/07)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1979 (06/01/06)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *8 DE Reg. 1024 (1/1/05)*
- *8 DE Reg. 1618 (5/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1024 (1/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *13 DE Reg. 1209 (03/01/10)*
- *16 DE Reg. 641 (12/01/12)*

##### **16 Del. Admin. Code § 3000-3021** RESERVED {#sec-3000-3021 omnilex-key=us-de-regs-official--title-16--3000-3021}

**History**
- *14 DE Reg. 304 (10/01/10)*
- *25 DE Reg. 534 (11/01/21)*
- *25 DE Reg. 534 (11/01/21)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1370 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1235 (02/01/06)*
- *12 DE Reg. 793 (12/01/08)*
- *12 DE Reg. 793 (12/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/01/05)*
- *10 DE Reg. 706 (10/01/06)*
- *11 DE Reg. 1241 (03/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *9 DE Reg. 1372 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (05/01/05)*
- *9 DE Reg. 798 (11/01/05)*
- *Repealed 10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *9 DE Reg. 798 (11/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *9 DE Reg. 1978 (06/01/06)*
- *28 DE Reg. 673 (03/01/25)*
- *28 DE Reg. 673 (03/01/25)*
- *10 DE Reg. 706 (10/01/06)*
- *26 DE Reg. 964 (05/01/23)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg 773 (03/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *23 DE Reg. 63 (07/01/19)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *8 DE Reg. 1712 (06/01/05)*
- *10 DE Reg. 1700 (05/01/07)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1979 (06/01/06)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *8 DE Reg. 1024 (1/1/05)*
- *8 DE Reg. 1618 (5/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1024 (1/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *13 DE Reg. 1209 (03/01/10)*
- *16 DE Reg. 641 (12/01/12)*

##### **16 Del. Admin. Code § 3000-3022** RESERVED {#sec-3000-3022 omnilex-key=us-de-regs-official--title-16--3000-3022}

**History**
- *14 DE Reg. 304 (10/01/10)*
- *25 DE Reg. 534 (11/01/21)*
- *25 DE Reg. 534 (11/01/21)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1370 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1235 (02/01/06)*
- *12 DE Reg. 793 (12/01/08)*
- *12 DE Reg. 793 (12/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/01/05)*
- *10 DE Reg. 706 (10/01/06)*
- *11 DE Reg. 1241 (03/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *9 DE Reg. 1372 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (05/01/05)*
- *9 DE Reg. 798 (11/01/05)*
- *Repealed 10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *9 DE Reg. 798 (11/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *9 DE Reg. 1978 (06/01/06)*
- *28 DE Reg. 673 (03/01/25)*
- *28 DE Reg. 673 (03/01/25)*
- *10 DE Reg. 706 (10/01/06)*
- *26 DE Reg. 964 (05/01/23)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg 773 (03/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *23 DE Reg. 63 (07/01/19)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *8 DE Reg. 1712 (06/01/05)*
- *10 DE Reg. 1700 (05/01/07)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1979 (06/01/06)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *8 DE Reg. 1024 (1/1/05)*
- *8 DE Reg. 1618 (5/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1024 (1/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *13 DE Reg. 1209 (03/01/10)*
- *16 DE Reg. 641 (12/01/12)*

##### **16 Del. Admin. Code § 3000-3023** Residence {#sec-3000-3023 omnilex-key=us-de-regs-official--title-16--3000-3023}

Applicants must reside in Delaware to be eligible for benefits. Persons including the homeless (those with no fixed address or not living in a permanent dwelling) who currently live in Delaware and plan to stay, regardless of the length of time they have been here, meet the residency requirement. Verification of residence is required at the time of application, at each subsequent redetermination, and any time an address change is reported.

Persons who reside in Delaware but because of local mailing practices have an out‑ of‑ state address are considered residents.

Examples of acceptable verification of residence are a landlord statement, a lease, a utility bill, or a collateral statement.

3023.1 Assistance From Other States

Before an application for cash assistance can be approved, DSS must verify that an applicant who moved to Delaware within three (3) months of the application filing date is not a recipient of assistance in the state where he/she previously resided. The eligibility worker will contact the public assistance agency in that state to verify the client's status with the agency. The client's written notice that benefits have ended is also acceptable verification.

3023.2 Mailing Address

Cash assistance checks must be mailed to the residence of the recipient, protective, or voluntary payee unless the recipient:

Lives in an area where home delivery is not available or customary and the situation is verified. These recipients may have their cash assistance checks mailed to their own post office box.

OR

OR

Is homeless. These recipients may have their cash assistance checks mailed to the local DSS office.

3023.3 Migrant Families

Migrant families claiming Delaware residence meet the residency requirement if the family:

1. Reports earnings to DSS every month; and

2. Maintains a residence in Delaware and plans to return to it at the end of the seasonal employment; and

3. Meets all other categorical eligibility requirements.

3023.4 Temporary Visits Out of State

Recipients do not lose their residence status because of a temporary visit out of state provided that the visit does not exceed thirty (30) days and the recipients:

1. Intend to return to the State, and

2. Continue to maintain a home in the State.

The assistance case of a recipient who leaves the State with the intent to establish residence in another state must be closed. The recipient may receive one grant payment after leaving the State if he/she is ineligible in the new state until residency is established. No further payments can be made to a client living out of state without the written approval of the DSS Director. To obtain approval, a memo listing the reasons that the grant should continue is sent to the Director.

3023.5 Temporary Absence of a Child

A child who is temporarily absent from the home to receive medical care, or to attend school elsewhere because of special educational needs, such as enrollment in the Job Corps or Sterck School For the Deaf, may receive assistance if the following conditions exist:

1. The caretaker with whom the child is living continues to have responsibility for the child's care, and

2. The caretaker continues to maintain a home for the child; and

3. The caretaker plans for the child to return to the home at the end of the absence.

The nature and anticipated length of the absence is documented in the case record.

Children absent from the home for any other reasons longer than one hundred twenty (120) days may not continue to receive assistance.

Note: A child who is absent from the home as the result of a court action is not considered temporarily absent. In such cases the assistance for the child is terminated.

3023.6 Temporary Absences of a Caretaker

A caretaker who is temporarily absent from the home to receive medical care can receive cash assistance for a period not to exceed 90 days provided that:

1. The caretaker continues to maintain a home and be responsible for the children for whom assistance is received; and

2. The caretaker has arranged for a responsible adult to care for the children during the absence; and

3. The caretaker plans to return to the home at the end of the absence; and

4. The caretaker continues to meet all other technical and financial eligibility requirements of the category of assistance that he/she receives.

The nature of the caretaker's health problem and the anticipated length of the absence must be verified by a physician. If the absence continues for more than 90 days, the assistance case must be closed. The adult caring for the children in the assistance unit at the time of the closing may apply for assistance for the children if they are still in need.

3023.7 Other Absences of a Caretaker

In active cases, a caretaker who is temporarily absent from the home for reasons other than to receive medical care (e.g., to handle a family emergency or seek employment) may continue to receive assistance for a period not to exceed thirty (30) days if the conditions listed in DSSM 3023.5 are met.

The nature and anticipated length of the absence must be documented in the case record. If the absence continues for more than thirty (30) days, the assistance case must be closed. The adult caring for the children in the assistance unit at the time of the closing may apply for assistance for the children if they are still in need.

3023.8 Grants to Those Institutionalized

No grant payment may be authorized or continued for an institutionalized individual. Examples of institutions include veteran's institutions, state mental institutions, hospitals for tuberculosis and prisons.

3023.9 TANF and GA Overlapping Eligibility

People can only receive one cash assistance payment for themselves at a time. This means that a person cannot be open in more than one DCIS case nor can they be open in more than one assistance group at the same time.

This does not preclude a person moving in the same month from GA assistance group to a TANF assistance group in the same month. Please see DSSM 3023.9.1 ABC and GA Overlapping Eligibility Exception.

3023.9.1 ABC and GA Overlapping Eligibility Exception

An individual can receive a GA benefit and become eligible for TANF in the same month. The individual is entitled to the difference between the GA benefit received and the TANF benefit. An example of this is when a pregnant woman receiving GA has her baby and is opened in TANF. In this situation the GA assistance group is closed for the mother after the baby is born.

**History**
- *14 DE Reg. 304 (10/01/10)*
- *25 DE Reg. 534 (11/01/21)*
- *25 DE Reg. 534 (11/01/21)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1370 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1235 (02/01/06)*
- *12 DE Reg. 793 (12/01/08)*
- *12 DE Reg. 793 (12/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/01/05)*
- *10 DE Reg. 706 (10/01/06)*
- *11 DE Reg. 1241 (03/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *9 DE Reg. 1372 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (05/01/05)*
- *9 DE Reg. 798 (11/01/05)*
- *Repealed 10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *9 DE Reg. 798 (11/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *9 DE Reg. 1978 (06/01/06)*
- *28 DE Reg. 673 (03/01/25)*
- *28 DE Reg. 673 (03/01/25)*
- *10 DE Reg. 706 (10/01/06)*
- *26 DE Reg. 964 (05/01/23)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg 773 (03/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *23 DE Reg. 63 (07/01/19)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *8 DE Reg. 1712 (06/01/05)*
- *10 DE Reg. 1700 (05/01/07)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1979 (06/01/06)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *8 DE Reg. 1024 (1/1/05)*
- *8 DE Reg. 1618 (5/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1024 (1/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *13 DE Reg. 1209 (03/01/10)*
- *16 DE Reg. 641 (12/01/12)*

##### **16 Del. Admin. Code § 3000-3024** Citizens and Aliens {#sec-3000-3024 omnilex-key=us-de-regs-official--title-16--3000-3024}

[233.50]

Only U.S. citizens and qualified aliens, as defined in section 431 of PRWORA, are eligible to receive cash assistance benefits.

Citizens are those persons born in the 50 states and the District of Columbia, Puerto Rico, Guam, U.S. Virgin Islands, and Northern Mariana Islands. Children born outside of the United States are citizens if they meet one of the following conditions:

Qualified aliens who entered the United States prior to August 22, 1996 are treated as if they were United States citizens. Qualified aliens are defined as aliens who are:

1. An alien lawfully admitted for permanent residence under the Immigration and Nationality Act (INA);

2. An alien granted asylum under section 208 of the INA;

3. A refugee admitted to the United States under section 207 of the INA;

4. An alien paroled into the United States under section 212(d)(5) of the INA for a period of at least 1 year;

5. An alien whose deportation is being withheld under section 243(h) of the INA as in effect prior to April 1, 1997, or whose removal is being withheld under section 241(b)(3) of the INA;

6. An alien granted conditional entry under section 203(a)(7) of the INA as in effect prior to April 1, 1980;

7. An alien who is a Cuban or Haitian entrant; or

8. An alien who (or whose child or parent) has been battered or subjected to extreme cruelty in the United States and otherwise satisfies the requirements of 8 U.S.C. 1641(c).

Qualified aliens admitted on or after August 22, 1996, are barred from receiving cash benefits for five (5) years, except for certain excepted groups described below who are not subject to the bar. The following excepted groups of aliens are exempt from the 5-year ban on benefits:

1. Qualified aliens lawfully residing in the State who are honorably discharged veterans and who fulfill minimum active-duty service requirements, or who are on non-training active duty in the U.S. Armed Forces, or who are the spouse, unmarried dependent child, or unremarried surviving spouse of such a veteran or active-duty personnel, provided that, in the latter case, the marriage satisfied the requirements of 38 U.S.C. § 1304;

2. Refugees, for a period of five years after the date they entered the U.S. as refugees;

3. Asylees, for a period of five years after obtaining such status;

4. Aliens whose deportation of removal has been withheld, for a period of five years after obtaining such status;

5. Cuban/Haitian entrants, as defined in section 501(e) of the Refugee Education Assistance Act of 1980, for a period of five years after they obtain such status; and

6. Amerasian immigrants from Vietnam, admitted to the U.S. pursuant to section 84 of the Foreign Operations, Export Financing, and Related Programs Appropriations Act of !988, for a period of five years after their admission.

7. Individuals who are eligible due to being lawfully admitted for permanent residence (LPR) who can be credited with 40 quarters of work;

8. Victims of Severe Trafficking per Public Law 106-386 Trafficking Victims Protection Act of 2000:

Severe forms of trafficking is defined as,

Adult victims of severe trafficking will be certified by the U. S. Department of Health and Human Services (HHS) and will receive a certification letter. Children, those under 18 years of age, who are victims of severe trafficking do not need to be certified but will receive a letter stating that the child is a victim of a severe form of trafficking. These victims of trafficking are treated like refugees. Victims of trafficking do not have to hold a certain immigration status, but they need to be certified by HHS in order to be eligible for cash assistance; and

9. An alien who (or whose child or parent) has been battered or subjected to extreme cruelty in the United States and otherwise satisfies the requirements of 8 U.S.C. 1641(c).

Documentation:

1. Lawful permanent resident status is verified by:

2. Refugee status is verified by:

3. Asylee status is verified by:

4. The status of an alien whose deportation is withheld is verified by:

5. Cuban/Haitian entrant status is verified by:

6. Amerasian immigrant status is verified by:

7. The 40 qualifying quarters of work is determined under Title II of the Social Security Act. This includes the quarters of work not covered by Title II of the Social Security Act. Quarters of work not covered by Title II of the Social Security Act is based on the sum of the following:

NOTE: A spouse cannot get credit for quarters of coverage of a spouse when the couple divorces before determination of eligibility is made. If a determination of eligibility has been made based on the quarters of coverage of a spouse, and the couple later divorces, the alien's eligibility continues until the next recertification. At that time, eligibility is determined without crediting the alien with the former spouse's quarters of coverage. (Beginning January 1, 19997, any quarter in which the alien received any Federal means-tested benefits does not count as a qualifying quarter. A parent's or spouse's quarter is not creditable if the parent or spouse received any Federal means-tested benefits or actually received food stamps in that quarter. If an alien earns the 40th quarter of coverage before applying for food stamps or any other Federal means-tested benefit in that same quarter, all that quarter toward the 40 qualifying quarters total.);

8. When a victim of a severe form of trafficking applies for benefits, DSS will follow normal procedures for refugees except DSS will:

9. For aliens who (or whose child or parent) is claiming that they have been battered or subjected to extreme cruelty in the United States and otherwise meets the requirements of 8 U.S.C. 1641(c) call THE Program and Policy Development Unit (PPDU) to determine if the documentation provided is satisfactory.

Aliens admitted as temporary residents are not eligible for public assistance benefits. Included are visitors, tourists, diplomats, and students.

Citizenship and alien status are verified at the time of application.

**History**
- *14 DE Reg. 304 (10/01/10)*
- *25 DE Reg. 534 (11/01/21)*
- *25 DE Reg. 534 (11/01/21)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1370 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1235 (02/01/06)*
- *12 DE Reg. 793 (12/01/08)*
- *12 DE Reg. 793 (12/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/01/05)*
- *10 DE Reg. 706 (10/01/06)*
- *11 DE Reg. 1241 (03/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *9 DE Reg. 1372 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (05/01/05)*
- *9 DE Reg. 798 (11/01/05)*
- *Repealed 10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *9 DE Reg. 798 (11/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *9 DE Reg. 1978 (06/01/06)*
- *28 DE Reg. 673 (03/01/25)*
- *28 DE Reg. 673 (03/01/25)*
- *10 DE Reg. 706 (10/01/06)*
- *26 DE Reg. 964 (05/01/23)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg 773 (03/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *23 DE Reg. 63 (07/01/19)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *8 DE Reg. 1712 (06/01/05)*
- *10 DE Reg. 1700 (05/01/07)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1979 (06/01/06)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *8 DE Reg. 1024 (1/1/05)*
- *8 DE Reg. 1618 (5/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1024 (1/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *13 DE Reg. 1209 (03/01/10)*
- *16 DE Reg. 641 (12/01/12)*

##### **16 Del. Admin. Code § 3000-3025** Effects of Participating in a Strike {#sec-3000-3025 omnilex-key=us-de-regs-official--title-16--3000-3025}

Any individual who participates in a strike is not eligible for cash assistance. If the individual is also the natural or adoptive parent with whom an eligible child is living, the entire family is ineligible for assistance. When participation in a strike begins after the receipt of an assistance grant, the grant for that month must be recovered as an overpayment.

A strike is defined as any concerted work stoppage by employees. This includes a stoppage that results when a collective bargaining agreement expires or any other concerted slowdown or interruption of operations by employees.

Participating in a strike means an employee's refusal in concert with others to work.

Participation in a strike is not considered good cause for leaving employment. It is also not considered good cause for refusing to seek or accept other employment.

EXAMPLES:

1. Mrs. Jones is receiving TANF for herself and three (3) grandchildren. She is employed full time. On August 10th she goes on strike. How is the TANF case affected?

Mrs. Jones is removed from the assistance unit. Her portion of the August grant is recovered as an overpayment. Her portion is a pro rata share of the grant received.

2. The situation is the same as above except Mrs. Jones is the children's mother. How is the TANF case affected?

The case must be closed and the August payment recovered as an overpayment.

Note: If participation in a strike begins any time after the issuance of a grant, the entire month's grant for the affected individual must be recovered. This is true even if the strike begins on the last day of the month.

A striker who subsequently quits his job is no longer a striker and the strike provisions explained above no longer apply. In such cases, the DSS worker will verify that the individual has quit his job before any case changes are made.

**History**
- *14 DE Reg. 304 (10/01/10)*
- *25 DE Reg. 534 (11/01/21)*
- *25 DE Reg. 534 (11/01/21)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1370 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1235 (02/01/06)*
- *12 DE Reg. 793 (12/01/08)*
- *12 DE Reg. 793 (12/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/01/05)*
- *10 DE Reg. 706 (10/01/06)*
- *11 DE Reg. 1241 (03/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *9 DE Reg. 1372 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (05/01/05)*
- *9 DE Reg. 798 (11/01/05)*
- *Repealed 10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *9 DE Reg. 798 (11/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *9 DE Reg. 1978 (06/01/06)*
- *28 DE Reg. 673 (03/01/25)*
- *28 DE Reg. 673 (03/01/25)*
- *10 DE Reg. 706 (10/01/06)*
- *26 DE Reg. 964 (05/01/23)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg 773 (03/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *23 DE Reg. 63 (07/01/19)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *8 DE Reg. 1712 (06/01/05)*
- *10 DE Reg. 1700 (05/01/07)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1979 (06/01/06)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *8 DE Reg. 1024 (1/1/05)*
- *8 DE Reg. 1618 (5/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1024 (1/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *13 DE Reg. 1209 (03/01/10)*
- *16 DE Reg. 641 (12/01/12)*

##### **16 Del. Admin. Code § 3000-3026** Application for Social Security Numbers {#sec-3000-3026 omnilex-key=us-de-regs-official--title-16--3000-3026}

Every applicant who does not have a valid Social Security Number (SSN) must apply for one before a cash assistance application can be approved. Applicants who do not have a SSN are referred to the appropriate SSA District Office or branch office to apply for one via Form 122. Each person referred to the SSA to apply for a SSN is instructed to return verification of the number to DSS when the number is received.

In the case of newborn children, the mother of the child must apply for a card for the child by the first day of the second month following the month the mother is discharged from the hospital.

EXAMPLE: A child is born on May 25th and the child's mother is discharged from the hospital on May 28th. The mother must apply for a SSN and provide DSS with verification of the application by July 1.

Benefits must be denied to any person who refuses to furnish or apply for a SSN. In the case of a minor child, if a parent refuses to cooperate in applying for a SSN for the child, the parent(s), the child and all eligible siblings are ineligible for assistance.

3026.1 Enumeration at Birth Procedures

Each applicant that does not have a SSN will be referred to the SSA to apply for a number as outlined below:

1. The worker informs the applicant at Intake that in order to be eligible for assistance, each family member must provide a Social Security Number or apply for a Social Security Number and report the assigned number to the agency.

2. The worker will complete Form 122 for clients who do not have a Social Security Number. The client is instructed to take the form to the SSA when applying for numbers, and is informed that SSA requires two (2) forms of identification for each person making application for a number, one of which must be a birth or baptismal certificate. Workers must emphasize that assistance cannot be approved until applications for missing numbers have been made and the completed Form 122 returned to DSS. A carbon or photocopy of the Form 122 is retained in the case record until the original is returned.

3. At intake, the worker allows the client thirty (30) days from the application filing date to apply for a Social Security Number and return a completed Form 122. In ongoing cases, the worker will give the client a deadline of not later than ten (10) days to apply for a Social Security Number and return the completed Form 122. If the client returns the Form 122 marked "The applicant was in to apply but no application has been made ....." the worker will not authorize assistance.

4. The above procedures apply to Social Security Numbers reported as missing on BENDEX report C35F1107 at redetermination, or at any other time it is discovered that a client does not have a Social Security Number and has not applied for one.

5. Clients who must apply for a Social Security Number are instructed to report the number to DSS as soon as it is received. Numbers will be verified through IEVS. See DSSM 2013.

**History**
- *14 DE Reg. 304 (10/01/10)*
- *25 DE Reg. 534 (11/01/21)*
- *25 DE Reg. 534 (11/01/21)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1370 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1235 (02/01/06)*
- *12 DE Reg. 793 (12/01/08)*
- *12 DE Reg. 793 (12/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/01/05)*
- *10 DE Reg. 706 (10/01/06)*
- *11 DE Reg. 1241 (03/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *9 DE Reg. 1372 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (05/01/05)*
- *9 DE Reg. 798 (11/01/05)*
- *Repealed 10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *9 DE Reg. 798 (11/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *9 DE Reg. 1978 (06/01/06)*
- *28 DE Reg. 673 (03/01/25)*
- *28 DE Reg. 673 (03/01/25)*
- *10 DE Reg. 706 (10/01/06)*
- *26 DE Reg. 964 (05/01/23)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg 773 (03/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *23 DE Reg. 63 (07/01/19)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *8 DE Reg. 1712 (06/01/05)*
- *10 DE Reg. 1700 (05/01/07)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1979 (06/01/06)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *8 DE Reg. 1024 (1/1/05)*
- *8 DE Reg. 1618 (5/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1024 (1/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *13 DE Reg. 1209 (03/01/10)*
- *16 DE Reg. 641 (12/01/12)*

##### **16 Del. Admin. Code § 3000-3027** Age as a Condition of Eligibility {#sec-3000-3027 omnilex-key=us-de-regs-official--title-16--3000-3027}

For purposes of determining eligibility for cash grants, persons 18 years old and over are considered adults.

Persons under age 18 are considered children.

An individual is not eligible for TANF as a child the month of his/her 18th birthday if their birthdate is the 1st day of the month. If such children are TANF recipients, they will be removed from the assistance unit the last day of the month prior to the month of their 18th birthday.

An individual is eligible for TANF as the child the month of his/her 18th birthday if their birthday is the 2nd - 31st day of the month. If such children are TANF recipients, they will be removed from the assistance unit effective the last day of the month he/she turns 18.

3027.1 18 Year Old Students

An 18 year old student who is still a full-time student in high school, GED, or equivalent program and will graduate prior to his/her 19th birthday may receive TANF as a child. The 18 year old would be removed from the assistance unit effective the last day of the month he/she graduates.

Example: Teen A will turn nineteen on October 3, 1994. Teen A will graduate from high school on June 14, 1994. When Teen A graduates on June 14, 1994, remove Teen A from the grant, effective June 30, 1994.

If the 18 year old originally scheduled to graduate prior to his/her 19th birthday but due to a change will now graduate after turning 19 years old, remove the 18 year old from the assistance unit.

Example: Teen C will turn nineteen on December 3, 1994. Initially, the school reported that Teen C would graduate on June 4, 1994. On March 4, 1994, we learn that Teen C will not graduate until June 4, 1995. Close Teen C in TANF, effective March 31, 1994.

3027.2 Minor Parents

An unmarried parent, under the age of 18, and the dependent child(ren) in his or her care is to reside in the household of a parent, legal guardian, custodian, other adult relative, or in an adult supervised supportive living arrangement to receive TANF benefits.

Emancipated minors are considered adults for the purpose of establishing eligibility for assistance. An eligible emancipated minor may receive an assistance grant in his/her own name.

Emancipation must be documented in the case record. Acceptable documentation includes:

1) Court records; or

2) The minor's valid marriage license; or

3) Written statements from the Division of Family Services verifying the minor's emancipation.

If the minor parent and his or her children reside in an adult supervised supportive living arrangement, the Division of Family Services, within the Department of Services for Children, Youth and Their Families, must approve the living arrangement by the next redetermination. If the adult supervised supportive living arrangement is not approved by the next redetermination, TANF payments should be stopped.

Assistance is to be provided in the form of a protective payment to the minor parent's parent, legal guardian, other adult relative, or adult in the supervised supportive living arrangement.

**History**
- *14 DE Reg. 304 (10/01/10)*
- *25 DE Reg. 534 (11/01/21)*
- *25 DE Reg. 534 (11/01/21)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1370 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1235 (02/01/06)*
- *12 DE Reg. 793 (12/01/08)*
- *12 DE Reg. 793 (12/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/01/05)*
- *10 DE Reg. 706 (10/01/06)*
- *11 DE Reg. 1241 (03/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *9 DE Reg. 1372 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (05/01/05)*
- *9 DE Reg. 798 (11/01/05)*
- *Repealed 10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *9 DE Reg. 798 (11/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *9 DE Reg. 1978 (06/01/06)*
- *28 DE Reg. 673 (03/01/25)*
- *28 DE Reg. 673 (03/01/25)*
- *10 DE Reg. 706 (10/01/06)*
- *26 DE Reg. 964 (05/01/23)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg 773 (03/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *23 DE Reg. 63 (07/01/19)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *8 DE Reg. 1712 (06/01/05)*
- *10 DE Reg. 1700 (05/01/07)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1979 (06/01/06)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *8 DE Reg. 1024 (1/1/05)*
- *8 DE Reg. 1618 (5/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1024 (1/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *13 DE Reg. 1209 (03/01/10)*
- *16 DE Reg. 641 (12/01/12)*

##### **16 Del. Admin. Code § 3000-3028** Assistance Units {#sec-3000-3028 omnilex-key=us-de-regs-official--title-16--3000-3028}

3028.1 Mandatory Composition of Assistance Units

In TANF, the assistance unit will always include:

1. The dependent child; and

2. The dependent child's blood‑ related or adoptive siblings who are under 18 and who are also dependent children; and

3. The dependent child's natural or adoptive parent(s). If both parents live in the home, both parents must be included in the unit regardless of the parents' marital status. In a case where paternity has not been legally established, the putative father must acknowledge paternity as a condition of eligibility.

Note: In 2 and 3 above, the child or parent must also reside in the home and be otherwise eligible. Examples of persons who are not otherwise eligible include, but are not limited to SSI recipients, and the Employment and Training Program sanctioned individuals.

EXAMPLE: A grandmother has day to day care and control of her minor grandchild and is receiving TANF for herself and the child. The child's mother moves into the home, but the grandmother retains custody and continues to act as the child's caretaker. Since, according to TANF regulations, a parent is a mandatory member of the assistance unit, the mother must be added. If the mother has income, the income must be budgeted. The grandmother may remain in the unit because TANF regulations allow for the inclusion of a needy caretaker relative.

EXAMPLE: In TANF, where children who live in the home include the caretaker's own children and a child who is related in some other manner (e.g., niece or nephew), establish two assistance units. One will include the caretaker and his/her children, and the other will include the other related child with the caretaker as payee only. When more than one such child lives in the home, each child will be placed in a separate assistance unit unless the children must be considered together as specified in 1 and 2 above.

3028.2 Optional Composition of Assistance Units

1. In TANF the dependent child, and if residing in the home and otherwise eligible, the child's blood-related or adoptive minor siblings, and the child's natural or adoptive parent(s) must be included in the unit. When both parents of the dependent child are in the home, both parents must be included in the unit regardless of their marital status. In a case where paternity has not been legally established, the putative father must acknowledge paternity as a condition of eligibility.

A non-parent needy caretaker relative may be included in the unit if the caretaker so chooses.

The needy legal spouse of a caretaker relative may be included in the unit only if the caretaker is the natural or adoptive parent of the child(ren), and the caretaker is incapacitated or is the principal wage earner and qualifies as an unemployed parent.

2. In TANF married/civil union couple cases, where each adult has children from previous relationships that are eligible for TANF, include the family in one TANF unit. If the couple has children in common who are also eligible for TANF, include these children in the unit also.

3. In TANF married, civil union, or unmarried couple cases where each adult has children from previous relationships who are eligible for TANF, they have the option of being in one assistance unit or two separate assistance units. If the unit fails financially, a separate assistance unit may be established for the child(ren) of the previous relationships.

EXAMPLE: A couple each have a child from previous relationships. Initially, we place all the family members into one TANF assistance unit. Income from Partner A’s job makes the family ineligible for TANF. We have the option of placing Partner B and his or her child from a previous relationship into a TANF assistance unit. In this scenario, if the couple were married/in a civil union, a step-parent situation would exist. If the couple were not married/in a civil union, eligibility is based solely on the information from Partner B and his or her child.

4. When a couple has a child in common and each partner has a child from a previous relationship, the couple, the child in common, and the other children will initially be placed in one TANF assistance unit. The siblings keep this as one assistance unit.

5. A pregnant woman, with no other children, may receive TANF beginning on the first day of the month that her child is expected to be born, if the woman meets all other technical and financial eligibility requirements, and her expected due date has been verified by a physician. The child is added to the unit, and a supplemental grant is effective the date of its birth if the birth is reported within five (5) days. If the birth is not reported within five (5) days, the child is added to the unit and the grant is effective as of the date of the report. The child's father, if he is otherwise eligible, is also added using these guidelines. Procedures for completing supplemental applications for newborns are outlined in DSSM 2000.6.5. (See DSSM 4010 Determining Financial Eligibility and Grant Amounts for Pregnant Women in TANF and GA)

A pregnant woman who plans to place her child for adoption is eligible for TANF beginning the 1st day of the month her child is due, assuming she meets all other eligibility requirements. If she still plans to terminate her parental rights after the child is born, the child cannot be added to the assistance unit and the child is not eligible for Medicaid. In this instance, the TANF case is closed at the end of the month that the birth occurs.

6. If a child receiving SSI is the only child in the home, the child's caretaker relative can receive TANF if the child is deprived of parental care. The caretaker's needy legal spouse can receive TANF if the caretaker is the child's natural or adoptive parent and the caretaker is incapacitated or qualifies as an unemployed parent.

7. For GA eligible adults, include the adult. The adult's spouse or UMP is also included if the spouse or partner also meets a condition of unemployability.

8. A woman who has a verified pregnancy and receives a GA check the month she delivers her child is eligible for TANF that month for herself and her child if she reports the birth to DSS, and she meets all other TANF technical and financial eligibility requirements.

The TANF grant is effective the date of the child's birth if the birth is reported within five (5) days.

The TANF grant is effective the date of the report if the birth is not reported within five (5) days.

If the pregnancy had not been verified, the TANF grant is effective the date the birth is verified.

**History**
- *14 DE Reg. 304 (10/01/10)*
- *25 DE Reg. 534 (11/01/21)*
- *25 DE Reg. 534 (11/01/21)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1370 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1235 (02/01/06)*
- *12 DE Reg. 793 (12/01/08)*
- *12 DE Reg. 793 (12/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/01/05)*
- *10 DE Reg. 706 (10/01/06)*
- *11 DE Reg. 1241 (03/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *9 DE Reg. 1372 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (05/01/05)*
- *9 DE Reg. 798 (11/01/05)*
- *Repealed 10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *9 DE Reg. 798 (11/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *9 DE Reg. 1978 (06/01/06)*
- *28 DE Reg. 673 (03/01/25)*
- *28 DE Reg. 673 (03/01/25)*
- *10 DE Reg. 706 (10/01/06)*
- *26 DE Reg. 964 (05/01/23)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg 773 (03/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *23 DE Reg. 63 (07/01/19)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *8 DE Reg. 1712 (06/01/05)*
- *10 DE Reg. 1700 (05/01/07)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1979 (06/01/06)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *8 DE Reg. 1024 (1/1/05)*
- *8 DE Reg. 1618 (5/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1024 (1/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *13 DE Reg. 1209 (03/01/10)*
- *16 DE Reg. 641 (12/01/12)*

##### **16 Del. Admin. Code § 3000-3029** Cooperation With Quality Control {#sec-3000-3029 omnilex-key=us-de-regs-official--title-16--3000-3029}

**History**
- *14 DE Reg. 304 (10/01/10)*
- *25 DE Reg. 534 (11/01/21)*
- *25 DE Reg. 534 (11/01/21)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1370 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1235 (02/01/06)*
- *12 DE Reg. 793 (12/01/08)*
- *12 DE Reg. 793 (12/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/01/05)*
- *10 DE Reg. 706 (10/01/06)*
- *11 DE Reg. 1241 (03/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *9 DE Reg. 1372 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (05/01/05)*
- *9 DE Reg. 798 (11/01/05)*
- *Repealed 10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *9 DE Reg. 798 (11/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *9 DE Reg. 1978 (06/01/06)*
- *28 DE Reg. 673 (03/01/25)*
- *28 DE Reg. 673 (03/01/25)*
- *10 DE Reg. 706 (10/01/06)*
- *26 DE Reg. 964 (05/01/23)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg 773 (03/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *23 DE Reg. 63 (07/01/19)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *8 DE Reg. 1712 (06/01/05)*
- *10 DE Reg. 1700 (05/01/07)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1979 (06/01/06)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *8 DE Reg. 1024 (1/1/05)*
- *8 DE Reg. 1618 (5/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1024 (1/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *13 DE Reg. 1209 (03/01/10)*
- *16 DE Reg. 641 (12/01/12)*

##### **16 Del. Admin. Code § 3000-3030** Cooperation With Audit and Recovery Management Services (ARMS) {#sec-3000-3030 omnilex-key=us-de-regs-official--title-16--3000-3030}

**History**
- *14 DE Reg. 304 (10/01/10)*
- *25 DE Reg. 534 (11/01/21)*
- *25 DE Reg. 534 (11/01/21)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1370 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1235 (02/01/06)*
- *12 DE Reg. 793 (12/01/08)*
- *12 DE Reg. 793 (12/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/01/05)*
- *10 DE Reg. 706 (10/01/06)*
- *11 DE Reg. 1241 (03/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *9 DE Reg. 1372 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (05/01/05)*
- *9 DE Reg. 798 (11/01/05)*
- *Repealed 10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *9 DE Reg. 798 (11/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *9 DE Reg. 1978 (06/01/06)*
- *28 DE Reg. 673 (03/01/25)*
- *28 DE Reg. 673 (03/01/25)*
- *10 DE Reg. 706 (10/01/06)*
- *26 DE Reg. 964 (05/01/23)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg 773 (03/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *23 DE Reg. 63 (07/01/19)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *8 DE Reg. 1712 (06/01/05)*
- *10 DE Reg. 1700 (05/01/07)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1979 (06/01/06)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *8 DE Reg. 1024 (1/1/05)*
- *8 DE Reg. 1618 (5/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1024 (1/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *13 DE Reg. 1209 (03/01/10)*
- *16 DE Reg. 641 (12/01/12)*

##### **16 Del. Admin. Code § 3000-3031** Reserved {#sec-3000-3031 omnilex-key=us-de-regs-official--title-16--3000-3031}

3031.1 Reserved

3031.2 Reserved

3031.3 Reserved

3031.3.1 Reserved

3031.3.2 Reserved

3031.4 Reserved

3031.5 Reserved

**History**
- *14 DE Reg. 304 (10/01/10)*
- *25 DE Reg. 534 (11/01/21)*
- *25 DE Reg. 534 (11/01/21)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1370 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1235 (02/01/06)*
- *12 DE Reg. 793 (12/01/08)*
- *12 DE Reg. 793 (12/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/01/05)*
- *10 DE Reg. 706 (10/01/06)*
- *11 DE Reg. 1241 (03/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *9 DE Reg. 1372 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (05/01/05)*
- *9 DE Reg. 798 (11/01/05)*
- *Repealed 10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *9 DE Reg. 798 (11/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *9 DE Reg. 1978 (06/01/06)*
- *28 DE Reg. 673 (03/01/25)*
- *28 DE Reg. 673 (03/01/25)*
- *10 DE Reg. 706 (10/01/06)*
- *26 DE Reg. 964 (05/01/23)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg 773 (03/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *23 DE Reg. 63 (07/01/19)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *8 DE Reg. 1712 (06/01/05)*
- *10 DE Reg. 1700 (05/01/07)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1979 (06/01/06)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *8 DE Reg. 1024 (1/1/05)*
- *8 DE Reg. 1618 (5/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1024 (1/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *13 DE Reg. 1209 (03/01/10)*
- *16 DE Reg. 641 (12/01/12)*

##### **16 Del. Admin. Code § 3000-3032** Diversion Assistance {#sec-3000-3032 omnilex-key=us-de-regs-official--title-16--3000-3032}

Administrative Notice A-05-2004.

Diversion Assistance is intended to help a family through a financial problem which jeopardizes employment and which, if not solved, could result in the family needing regular ongoing assistance. When the primary case worker and the client agree that the one-time payment will alleviate the crisis, Diversion Assistance will be explored. The Diversion Assistance payment will not exceed $1,500 or the financial need resulting from the crisis, whichever is less.

Diversion Assistance is not a supplement to regular assistance but is in place of it. Diversion Assistance is available to both applicant and recipient families.

3032.1.1 Eligibility for Diversion Assistance

The eligibility requirements for Diversion Assistance are as follows:

The parent must be living with his/her natural or adopted child(ren).

The family has not received a Diversion Assistance payment in the past 12 months.

The Diversion Assistance amount will alleviate the crisis.

The parent (a) is currently employed but having a problem which jeopardizes the employment; or (b) has been promised a job but needs help in order to accept the job.

The family’s income would qualify the family for TANF as a recipient household. (NOTE: When calculating eligibility for Diversion Assistance the family is given the “$30 plus 1/3” disregard, if applicable and the family’s net income is compared to the Standard of Need.)

The family’s resources would qualify the family for TANF

3032.1.2 Verification Requirements

A. The following items will be verified:

The identity of the parent making application for Diversion Assistance.

Alien status

The family’s income.

The employment or offer of employment.

The cost of services for eliminating the barrier to employment.

B. The following items will be accepted by declaration:

The Social Security numbers of the family members.

The date of birth of family members.

The relationship of family members.

The family’s resources.

Delaware residency.

Citizenship

Child care expenses.

3032.1.3 Items/Services Covered

A. The Diversion Assistance payment may be used for items and/or services such as but not limited to:

B. If transportation is the issue an expectation is that there is a discussion with the person regarding the cost effectiveness of repairing a vehicle versus purchasing a used vehicle or a new vehicle. We can authorize diversion assistance to be used as a down payment for purchasing a new vehicle.

C. If the diversion assistance payment is requested for the down payment on a vehicle several things must be considered in determining if it is approved. DSS will need to determine if the family’s income will be enough to meet the regular household expenses such as rent, utilities, and food, as well as the costs involved with owning and maintaining a vehicle. The costs of owning the vehicle include gas to fuel this vehicle, monthly payments, vehicle insurance and maintenance. Consider that fuel costs can vary based on the price of gas and the amount needed to drive to and from work and other daily life activities when the customer and DSS determines the potential monthly expense.

D. The Division of Vocational Rehabilitation has an Independent Living Program that will assist with home modifications and vehicle modifications. They will not purchase the vehicle. The only requirement is that they are disabled. They operate on a first come first serve basis and maintain a waiting list. If an individual has another agency to assist in the cost sharing they do get served more quickly. If we assisted in the purchase of the vehicle they would consider this a cost share. We would see if we could have the customer purchase an unmodified vehicle and then have DVR help with the modification. Then compare the DVR estimate in determining if the person could still accept or retain employment with the expected wait for the modification. Call 302-378-5779, if you have a situation for which this program may be beneficial.

E. Use the following guide to determine if the purchase request is fiscally sound and can be reasonable afforded.

1. Monthly Take Home Pay: $_______

2a. Basic Living Expenses:

Mortgage or Rent $_____

Utilities _____

Food _____

Clothing _____

Home/Renter Insurance _____

Medical Expense _____

Vehicle Maintenance _____

Vehicle Insurance _____

Gas for Vehicle _____

School Supplies _____

Household Expenses _____

Dependent Care Expenses _____

Other Regular Expenses _____

2b. Total Basic Expenses _____ _______

(copy total into second column)

3. Subtract line 2b from line 1 _______

(take home pay minus basic living expenses)

4. Divide the amount in line 3 by 3 _______

(money left after basic living expenses ÷ 3

The money in line 4 is how much can be safely spent on monthly payments each month. This guide is to be used anytime when the diversion request will result in the person making monthly payments to complete the purchase.

The Delaware Money School considers the following good money management. Spending from housing costs are @40%, utilities are @10%, food and other grocery items are @15%, travel and transportation costs are @15%, savings should be @10% and miscellaneous costs of clothing, medical, cleaning and bath supplies, etc. to be @10% of the take home pay.

NOTE:

It is not for DSS to provide a down payment on a luxury class new vehicle when other suitable less expensive and reliable vehicles for purchase are available. For instance, assuming that a specially equipped vehicle is not needed and the number of family members can be seated properly in the average vehicle, a request for a down payment on a new $30,000 Lexus is to be denied since there are may new vehicles that would fit the needs of the requester and provide reliable transportation for much less than that amount. That said, DSS will not set a monetary value on the vehicle to be purchased due to needs such as large family size or medically necessary specially equipped vehicles that will increase the cost of a vehicle. If all other eligibility and cost consideration factors are met and using the guide above the family can afford a $20,000 Toyota, diversion assistance can be approved, if all that is needed is money for a down payment.

Documentation Required:

The payment document can be in the form of an invoice, bill, or cost estimate. It needs to be on the vendor’s letterhead. All payment documents must include the name, address, and telephone number of the vendor and an original “live” signature. This information is necessary to ensure that proper fiscal accountability procedures are followed.

For automobile purchases or down payments the amount of purchase, year, make, model, and vehicle identification number (VIN) must be included on the payment document.

A check is issued to the vendor only. Make sure the customer name, customer address, MCI number, time period, the specific needs of the family, and the vendor's name and address are sent with the written estimate(s). The unit supervisor will then approve the diversion payment. The supervisor will sign the approval form. Keep a copy for the file. Forward the information to DSS Fiscal Office. The information will then be added to a database that will keep track of all diversion payments made. Staff will screen families through this data base to make certain a person has not received Diversion Assistance during a time period that makes the family ineligible for it again or Delaware's TANF program. The mailing address of the DSS Fiscal Office is:

Division of Social Services

Fiscal Office: Attention Diversion Assistance

Herman Holloway Sr. DHSS Campus

1901 N. DuPont Highway - Lewis Building

New Castle DE 19720

H150

DSS does not make any claims as to the quality of service provided, work performed, or goods delivered. It is up to the diversion assistance requester to seek remedy if the quality or performance is substandard. If the service provided, work performed, or goods delivered is of substandard quality. DSS will make attempts to stop payment on checks written, when able, and will provide copies of canceled checks to verify payment was made to the vendor in question if needed. It is up to the diversion assistance recipient to verify the quality was substandard. Diversion assistance will not be re-approved in a case in which the vendor has cashed the check unless good cause is claimed, the person verifies that they are taking legal means to have the situation rectified, and the request is approved by the Chief of Operations.

3032.1.4 Diversion Assistance Payments

3032.1.5 Diversion Assistance and TANF Cash Assistance

When the parent receives Diversion Assistance (s)he agrees to forego TANF cash assistance as follows:

$0 through $500.99 for 1 month.

$501 through $1,000.99 for 2 months.

$1,001 through $1,500 for 3 months.

3032.1.6 Good Cause

The once a year limitation on Diversion Assistance and the period of ineligibility can be eliminated when good cause exists. Good cause exists when circumstances beyond the client’s control make re-application for Diversion Assistance or TANF necessary. Examples of good cause are the employer lays off the parent or a serious illness forces the parent to stop working.

3032.2 Eligibility For Other Programs

A. Medicaid Eligibility

The family is eligible for TANF related Medicaid in the month in which the Diversion Assistance payment is made. The family would remain eligible for Section 1931 Medicaid (TANF-related Medicaid) until the family’s income exceeds the standard of need. If the family’s income exceeds the standard of need because of increase earnings or loss of the “$30 plus 1/3” disregard and the parent is working, the family may be eligible for Transitional Medicaid.

B. Child Care

Diversion Assistance does not count as income in the child care programs.

C. Child Support

The family will not have to assign child support to the state. Child support received by the parent or the Division of Child Support Enforcement (DSCE) will belong to the family. DCSE will not use child support to offset or reimburse the Diversion Assistance.

**History**
- *14 DE Reg. 304 (10/01/10)*
- *25 DE Reg. 534 (11/01/21)*
- *25 DE Reg. 534 (11/01/21)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1370 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1235 (02/01/06)*
- *12 DE Reg. 793 (12/01/08)*
- *12 DE Reg. 793 (12/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/01/05)*
- *10 DE Reg. 706 (10/01/06)*
- *11 DE Reg. 1241 (03/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *9 DE Reg. 1372 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (05/01/05)*
- *9 DE Reg. 798 (11/01/05)*
- *Repealed 10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *9 DE Reg. 798 (11/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *9 DE Reg. 1978 (06/01/06)*
- *28 DE Reg. 673 (03/01/25)*
- *28 DE Reg. 673 (03/01/25)*
- *10 DE Reg. 706 (10/01/06)*
- *26 DE Reg. 964 (05/01/23)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg 773 (03/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *23 DE Reg. 63 (07/01/19)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *8 DE Reg. 1712 (06/01/05)*
- *10 DE Reg. 1700 (05/01/07)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1979 (06/01/06)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *8 DE Reg. 1024 (1/1/05)*
- *8 DE Reg. 1618 (5/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1024 (1/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *13 DE Reg. 1209 (03/01/10)*
- *16 DE Reg. 641 (12/01/12)*

##### **16 Del. Admin. Code § 3000-3033** Interim Assistance Reimbursement {#sec-3000-3033 omnilex-key=us-de-regs-official--title-16--3000-3033}

3033.1 Requirements for Receipt of Cash Assistance by SSI Applicants

This policy applies to non-federally funded cash assistance recipients who have applied or intend to apply for SSI benefits.

1. Cash assistance applicants and recipients who are also SSI applicants are required to assign a portion of the SSI benefits they receive to the Division of Social Services to reimburse DSS for cash assistance received by the SSI applicant.

Delaware has an Interim Assistance Reimbursement (IAR) agreement with the Social Security Administration (SSA). This agreement allows Delaware's Division of Social Services (DSS) to receive reimbursement for the cash assistance provided to SSI applicants while their SSI eligibility decision was pending. The money reimbursed to the State is taken from the SSI applicant's initial and retroactive SSI benefits.

2. To be eligible for cash assistance, SSI applicants must authorize reimbursement through the IAR agreement for cash assistance received while SSI eligibility determination is pending.

3. A cash recipient is considered an SSI applicant if one or more of the following conditions exists:

A. The cash recipient has applied for SSI and is waiting for an eligibility decision.

B. The cash recipient has applied for reinstatement of SSI benefits and is waiting for a decision.

C. The cash recipient has received a request from DSS or another state agency to apply for SSI benefits.

D. The cash recipient has reported they intend to apply for SSI benefits or reinstatement of SSI benefits.

4. SSI applicants assign their SSI benefits to DSS by completing and signing a DSS approved IAR authorization form.

A cash recipient is required to complete an IAR authorization form when:

A. The client reports he or she intends to apply for SSI.

B. The client has made an application or reapplication for SSI benefits.

C. Documentation is provided from a health care provider that indicates the client is unable to work and the disability is expected to exceed 6 months in duration.

D. The client has applied or intends to apply to have SSI benefits reinstated after suspension or termination.

E. The IAR authorization form on file is more than 30 days old and the client has not applied for SSI.

F. The client is required to apply for SSI by DSS or another State agency.

**History**
- *14 DE Reg. 304 (10/01/10)*
- *25 DE Reg. 534 (11/01/21)*
- *25 DE Reg. 534 (11/01/21)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1370 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1235 (02/01/06)*
- *12 DE Reg. 793 (12/01/08)*
- *12 DE Reg. 793 (12/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/01/05)*
- *10 DE Reg. 706 (10/01/06)*
- *11 DE Reg. 1241 (03/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *9 DE Reg. 1372 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (05/01/05)*
- *9 DE Reg. 798 (11/01/05)*
- *Repealed 10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *9 DE Reg. 798 (11/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *9 DE Reg. 1978 (06/01/06)*
- *28 DE Reg. 673 (03/01/25)*
- *28 DE Reg. 673 (03/01/25)*
- *10 DE Reg. 706 (10/01/06)*
- *26 DE Reg. 964 (05/01/23)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg 773 (03/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *23 DE Reg. 63 (07/01/19)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *8 DE Reg. 1712 (06/01/05)*
- *10 DE Reg. 1700 (05/01/07)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1979 (06/01/06)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *8 DE Reg. 1024 (1/1/05)*
- *8 DE Reg. 1618 (5/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1024 (1/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *13 DE Reg. 1209 (03/01/10)*
- *16 DE Reg. 641 (12/01/12)*

##### **16 Del. Admin. Code § 3000-3034** RESERVED {#sec-3000-3034 omnilex-key=us-de-regs-official--title-16--3000-3034}

**History**
- *14 DE Reg. 304 (10/01/10)*
- *25 DE Reg. 534 (11/01/21)*
- *25 DE Reg. 534 (11/01/21)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1370 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/1/05)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1235 (02/01/06)*
- *12 DE Reg. 793 (12/01/08)*
- *12 DE Reg. 793 (12/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1618 (5/01/05)*
- *10 DE Reg. 706 (10/01/06)*
- *11 DE Reg. 1241 (03/01/08)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 826 (02/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *9 DE Reg. 1372 (03/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (05/01/05)*
- *9 DE Reg. 798 (11/01/05)*
- *Repealed 10 DE Reg. 706 (10/01/06)*
- *8 DE Reg. 1618 (5/1/05)*
- *9 DE Reg. 798 (11/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *9 DE Reg. 1978 (06/01/06)*
- *28 DE Reg. 673 (03/01/25)*
- *28 DE Reg. 673 (03/01/25)*
- *10 DE Reg. 706 (10/01/06)*
- *26 DE Reg. 964 (05/01/23)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg 773 (03/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 63 (07/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *23 DE Reg. 63 (07/01/19)*
- *23 DE Reg. 63 (07/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *18 DE Reg. 143 (08/01/14)*
- *10 DE Reg. 706 (10/01/06)*
- *18 DE Reg. 143 (08/01/14)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *23 DE Reg. 384 (11/01/19)*
- *10 DE Reg. 706 (10/01/06)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *23 DE Reg. 63 (07/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *13 DE Reg. 847 (12/01/09)*
- *22 DE Reg. 773 (03/01/19)*
- *14 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *10 DE Reg. 304 (10/01/10)*
- *8 DE Reg. 1712 (06/01/05)*
- *10 DE Reg. 1700 (05/01/07)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *9 DE Reg. 1979 (06/01/06)*
- *14 DE Reg. 304 (10/01/10)*
- *14 DE Reg. 304 (10/01/10)*
- *15 DE Reg. 1498 (04/01/12)*
- *8 DE Reg. 1024 (1/1/05)*
- *8 DE Reg. 1618 (5/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *8 DE Reg. 1024 (1/1/05)*
- *10 DE Reg. 706 (10/01/06)*
- *14 DE Reg. 1073 (04/01/11)*
- *13 DE Reg. 1209 (03/01/10)*
- *16 DE Reg. 641 (12/01/12)*

#### **5000** Fair Hearing Practice and Procedures

##### **16 Del. Admin. Code § 5000** Definitions {#sec-5000 omnilex-key=us-de-regs-official--title-16--5000}

**History**
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 1343 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 568 (01/01/18)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 879 (05/01/18)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *10 DE Reg. 1703 (05/01/07)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *8 DE Reg. 351 (8/1/04)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 1339 (03/01/12)*
- *15 DE Reg. 1339 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 86 (07/01/11*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *14 DE Reg. 618 (01/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*

##### **16 Del. Admin. Code § 5000-42** CFR 438.400 {#sec-5000-42 omnilex-key=us-de-regs-official--title-16--5000-42}

Abandonment

When the claimant fails without good cause, to appear (by themselves or by authorized representative) at their scheduled hearing.

Adequate Notice

A written notice that includes:

1. A statement of what action the agency intends to take

2. The reasons for the intended agency action

3. The specific regulations supporting such action

4. An explanation of the individual's right to request a State agency hearing

5. The circumstances under which assistance is continued if a hearing is requested

6. If the agency action is upheld, that such assistance must be repaid under title IV-A, and must also be repaid under titles I, X, XIV or XVI (AABD) if the State plan provides for recovery of such payments.

Advance Notice Period

The 10 day period between the date a notice is mailed to the date a proposed action is to take effect. (Also called Timely Notice Period.)

Adverse Benefit Determination

For recipients enrolled in a MCO, the denial or limited authorization of a requested service, including determinations based on the type or level of service, requirements for medical necessity, appropriateness, setting, or effectiveness of a covered benefit; the reduction, suspension, or termination of a previously authorized service; the denial, in whole or in part, of payment for a service; the failure to provide services in a timely manner, as defined by the State; the failure of the MCO to act within timeframes regarding the standard resolution of grievances and appeals; and the denial of a recipient's request to dispute a financial liability, including cost sharing, copayments, and other recipient financial liabilities.

Appellant

Anyone who requests a hearing. (Also called Claimant.)

Benefits

Any kind of assistance, payments or benefits made by TANF, GA, Medicaid, Delaware Healthy Children Program (DHCP), Chronic Renal Disease Program (CRDP), Child Care, Refugee, Emergency Assistance or Food Supplement programs.

Claimant

Anyone who requests a hearing. (Also called Appellant.)

DHSS

The Department of Health and Social Services, including:

1. The Division of Social Services (DSS), in connection with economic, medical, vocational or child care subsidy assistance

2. The Division of Medicaid and Medical Assistance (DMMA) or a managed care organization (MCO) under contract with DHSS to manage an operation of the Medicaid Program, in connection with medical assistance

3. The Division of State Service Centers (DSSC) in connection with the Emergency Assistance Program

4. The Division of Developmental Disabilities Services (DDDS) in connection with Medicaid Program services

5. The Division of Public Health in connection with Medicaid Program services

6. The Division of Services for the Aging and Adults with Physical Disabilities (DSAAPD) in connection with Medicaid Program services

DSS

The Division of Social Services (or "the Division.")

Expedited Fair Hearing

An administrative hearing for Medicaid and DHCP which provides for a decision to be issued within 3 working days from the receipt of the request for an appeal of a decision to terminate, reduce, or suspend previously authorized services or a decision to deny or limit a new service request where the standard decision time frame of 45 days could seriously jeopardize the claimant’s life or health or ability to attain, maintain, or regain maximum function.

Fair Hearing

An administrative hearing held in accordance with the principles of due process which include:

1. Timely and adequate notice

2. The right to confront and cross-examine adverse witnesses

3. The opportunity to be heard orally

4. The right to an impartial decision maker

5. The opportunity to obtain counsel, represent him or herself, or use any other person of his or her choice.

Fair Hearing Summary

A document prepared by the agency stating the factual and legal reason(s) for the action under appeal. The purpose of the hearing summary is to state the position of the agency/entity that initiated the action in order to provide the appellant with the necessary information to prepare their case.

Good Cause

May include, but is not limited to the following:

1. Death in the family

2. Personal injury or illness

3. Sudden and unexpected emergencies

4. Failure to receive the hearing notice

Group Hearing

A series of individual requests for a hearing consolidated into a single group hearing. A group hearing is appropriate when the sole issue involved is one of State or federal law, regulation, or policy. The policies governing hearings will be followed In all group hearings. The individual appellant in a group hearing is permitted to present their case or be represented by an authorized representative.

Hearing Decision

The decision in a case appealed to the State hearing officer. The decision includes:

1. The substance of what transpired at the hearing

2. A summary of the case facts

3. Supporting evidence

4. Pertinent State or federal regulations

5. The reason for the decision

In Food Supplement Program disqualification cases, the hearing decision must also respond to reasoned arguments by the appellant.

EXAMPLE: At a Food Supplement Program Intentional Program Violation Hearing involving a failure to report a change promptly, an appellant may argue that a failure to report does not constitute "clear and convincing evidence" of intent to defraud. The hearing officer's decision must respond to this argument.

Hearing Officer

The individual responsible for conducting the hearing and issuing a final decision on issues of fact and questions of law.

Hearing Record

A verbatim transcript of all evidence and other material introduced at the hearing, the hearing decision, and all other correspondence and documents which are admitted as evidence or otherwise included for the hearing record by the hearing officer.

Hearing Summary

A document prepared by the agency stating the factual and legal reason(s) for the action under appeal. The purpose of the hearing summary is to state the position of the agency/entity that initiated the action in order to provide the appellant with the necessary information to prepare their case.

Hearsay Evidence

Testimony about a statement made by a third party that is offered as fact without personal knowledge

Individual Hearing

A hearing in which an individual client disagrees with the action taken by the Department on the facts of their case.

MCO

A Managed Care Organization under contract with DHSS to administer the delivery of medical services to recipients of Medicaid and CHIP through a network of participating providers.

Party

A party to a hearing is a person or an administrative agency or other entity who has taken part in or is concerned with an action under appeal. A party may be composed of one or more individuals.

Privilege

Appellants may decline to present testimony or evidence at a fair hearing under claim of privilege. Privilege may include the privilege against self- incrimination or communication to an attorney, a religious advisor, a physician, etc.

Request for a Fair Hearing

Any clear expression (oral or written) by the appellant or their authorized agent that the individual wants to appeal a decision to a higher authority. Such request may be oral in the case of actions taken under the Medical Assistance or Food Supplement Programs. The agency must establish procedures that permit an individual, or an authorized representative, to submit a hearing request for Medical Assistance:

1. Via the internet website;

2. By telephone;

3. Via mail;

4. In person; and

5. Through other commonly available electronic means.

Relevance

Refers to evidence. Evidence is relevant if an average person believes that the evidence makes a significant fact more probable.

Remand

To send back for further action.

Rule of Residuum

Findings of fact must be supported by at least some evidence which is admissible in a court of law.

Timely Notice Period

The 10 day period between the date a notice is mailed to the date a proposed action is to take effect. (Also called Advance Notice Period.)

**History**
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 1343 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 568 (01/01/18)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 879 (05/01/18)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *10 DE Reg. 1703 (05/01/07)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *8 DE Reg. 351 (8/1/04)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 1339 (03/01/12)*
- *15 DE Reg. 1339 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 86 (07/01/11*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *14 DE Reg. 618 (01/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*

##### **16 Del. Admin. Code § 5000-5001** Providing an Opportunity for a Fair Hearing {#sec-5000-5001 omnilex-key=us-de-regs-official--title-16--5000-5001}

7 CFR 273.15(f), 42 CFR 431.206, 45 CFR 205.10, 42 CFR 438.402, 42 CFR 457.1120

This policy applies to all applicants and recipients of DSS and DMMA for services provided directly by the Agencies or through agreements with other State or contracted entities where the applicant or recipient claims that he/she has been adversely impacted by a specific action taken by DSS or DMMA. This policy does not create any new right of appeal outside DSS or DMMA, nor does it restrict an existing right to any other fair hearing process to which the applicant or recipient may be entitled.

1. Staff Offer Clients an Opportunity to be Heard

An opportunity for a fair hearing will be provided, subject to the provisions of this section, to any individual requesting a hearing who is dissatisfied with a decision of the Division of Social Services or the Division of Medicaid and Medical Assistance.

The agency will promptly inform a claimant in writing if assistance is to be discontinued under any circumstance pending a hearing decision.

2. Staff Inform Clients in Writing of Their Hearing Rights

Every applicant and recipient will be informed in writing of his or her right to a fair hearing as provided under this section:

A. At the time of application

B. At the time of any action affecting the applicant’s or recipient’s claim

C. At the time a skilled nursing facility or a nursing facility notifies DSS or DMMA of a Medicaid applicant’s or recipient’s potential transfer or discharge, which may adversely affect the applicant’s or recipient’s Medicaid eligibility.

D. At the time an individual receives an adverse determination by the State with regard to the preadmission screening resident review PASRR requirements.

**History**
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 1343 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 568 (01/01/18)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 879 (05/01/18)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *10 DE Reg. 1703 (05/01/07)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *8 DE Reg. 351 (8/1/04)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 1339 (03/01/12)*
- *15 DE Reg. 1339 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 86 (07/01/11*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *14 DE Reg. 618 (01/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*

##### **16 Del. Admin. Code § 5000-5100** Reserved {#sec-5000-5100 omnilex-key=us-de-regs-official--title-16--5000-5100}

**History**
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 1343 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 568 (01/01/18)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 879 (05/01/18)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *10 DE Reg. 1703 (05/01/07)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *8 DE Reg. 351 (8/1/04)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 1339 (03/01/12)*
- *15 DE Reg. 1339 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 86 (07/01/11*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *14 DE Reg. 618 (01/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*

##### **16 Del. Admin. Code § 5000-5200** Informing Clients of Their Right to a Fair Hearing {#sec-5000-5200 omnilex-key=us-de-regs-official--title-16--5000-5200}

7 CFR 273.15(f), 45 CFR 205.10

This policy applies to every applicant and recipient under any public assistance program administered by the Division of Social Services or the Division of Medicaid and Medical Assistance.

Staff provides applicants and recipients with written information about their right to a fair hearing as provided under this section. This information is provided at the time of application and at the time of any action affecting their claim.

**History**
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 1343 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 568 (01/01/18)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 879 (05/01/18)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *10 DE Reg. 1703 (05/01/07)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *8 DE Reg. 351 (8/1/04)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 1339 (03/01/12)*
- *15 DE Reg. 1339 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 86 (07/01/11*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *14 DE Reg. 618 (01/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*

##### **16 Del. Admin. Code § 5000-5300** Providing Adequate and Timely Notices {#sec-5000-5300 omnilex-key=us-de-regs-official--title-16--5000-5300}

7 CFR 273.15(f), 42 CFR 431.210, 42 CFR 438.404, 42 CFR 457.340, 45 CFR 205.10

This policy applies to every applicant and recipient under any public assistance program administered by the Division of Social Services (DSS) or the Division of Medicaid and Medical Assistance (DMMA).

1. DSS and DMMA Provide Written Notice of Agency Actions

Written notice of an agency action will contain:

A. A statement of the client's right to a fair hearing as provided under this section.

B. The method by which he or she may request a fair hearing.

C. A statement that he or she may represent him/herself or that he or she may be represented by counsel or by another person.

2. DSS and DMMA Take Action Only Under Certain Conditions

No action may be taken unless the following conditions are met:

A. Written notice is provided to the client that is "adequate."

An adequate notice is a written notice that includes

1. A statement of what action the agency intends to take

2. The reasons for the intended agency action

3. The specific regulations supporting such action

4. Explanation of the individual's right to request a State agency hearing

5. The circumstances under which assistance is continued if a hearing is requested

6. If the agency action is upheld, that such assistance

i. Must be repaid under Title IV-A

ii. Must be repaid under Titles I, X, XIV or XVI (AABD) if the State plan provides for recovery of such payments

iii. May be repaid under Title XIX

B. Written notice is provided to the client that is "timely.”

A timely notice is one that is mailed at least 10 days before the date of action.

Exception: For TANF, notice is timely if mailed at least 5 days before the action would become effective when DSS learns of facts indicating that assistance should be discontinued, suspended, terminated, or reduced because of the probable fraud of the recipient, and, where possible, such facts have been verified through secondary sources.

C. Each recipient is advised of his or her potential liability for repayment of benefits received while awaiting a fair hearing if the agency's decision is upheld.

Continue benefits if the hearing request form is unclear as to whether the recipient wants continued benefits or not. Provide continued benefits within 5 working days of the date the agency received the household's request.

Exception: Food Supplement Program households do not have a right to a continuation of benefits while waiting for the fair hearing when the recipient is disputing a reduction, suspension or cancellation of benefits as a result of an order issued by FNS.

During the fair hearing period, the agency will adjust allotments to take into account reported changes except for the factor(s) on which the hearing is based.

D. Each notice contains information needed for the claimant to determine from the notice alone, the accuracy of the Division's action or intended action.

All notices will:

Indicate the action or proposed action to be taken (i.e., approval, denial, reduction, or termination of assistance);

a. Provide citation(s) to the regulation(s) supporting the action being taken;

b. Provide a detailed individualized explanation of the reason(s) for the action being taken which includes, in terms understandable to the claimant:

i. An explanation of why the action is being taken, and

ii. An explanation of what the claimant was required by the regulation to do and why his or her actions fail to meet this standard (if the action is being taken because of the claimant's failure to perform an act required by a regulation)

c. Provide:

i. explanations of what income and/or resources the agency considers available to the claimant

ii. the source or identity of these funds,

iii. the calculations used by the agency,

iv. the relevant eligibility limits and maximum benefit payment levels for a family or assistance unit of the claimant's size.

**History**
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 1343 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 568 (01/01/18)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 879 (05/01/18)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *10 DE Reg. 1703 (05/01/07)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *8 DE Reg. 351 (8/1/04)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 1339 (03/01/12)*
- *15 DE Reg. 1339 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 86 (07/01/11*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *14 DE Reg. 618 (01/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*

##### **16 Del. Admin. Code § 5000-5301** RESERVED {#sec-5000-5301 omnilex-key=us-de-regs-official--title-16--5000-5301}

**History**
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 1343 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 568 (01/01/18)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 879 (05/01/18)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *10 DE Reg. 1703 (05/01/07)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *8 DE Reg. 351 (8/1/04)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 1339 (03/01/12)*
- *15 DE Reg. 1339 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 86 (07/01/11*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *14 DE Reg. 618 (01/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*

##### **16 Del. Admin. Code § 5000-5302** Making Exceptions to Timely Notice Rules {#sec-5000-5302 omnilex-key=us-de-regs-official--title-16--5000-5302}

42 CFR 431.213

This policy applies to every applicant and recipient under any public assistance program administered by the Division of Social Services (DSS) or the Division of Medicaid and Medical Assistance (DMMA).

The agency may dispense with timely notice but will send adequate notice not later than the date of action when:

A. The agency has factual information confirming the death of the recipient or of the TANF payee when there is no relative available to serve as the new payee.

B. The recipient provides a clear written statement that assistance is no longer desired.

C. The recipient provides information which requires termination or reduction of assistance and the recipient has indicated in writing that (s)he understands that the action is a consequence of supplying the information.

D. The recipient has been admitted or committed to an institution where he is ineligible for services (See §3010.9).

E. The recipient has been placed in skilled nursing care, intermediate care, or long-term hospitalization.

F. The appellant's whereabouts are unknown and agency mail directed to him/her has been returned by the post office indicating no known forwarding address. If his/her whereabouts become known during the payment period, the client's check will be made available.

G. The recipient's case has been accepted for assistance in another state or territory or for another category of assistance including SSI, and, that fact has been established by the Department.

H. A child is no longer in the home, including when a child is removed from a home as a result of a judicial determination or voluntarily placed in foster care by his or her legal guardian.

I. A change in the level of medical care is prescribed by the recipient's physician.

J. In the Emergency Assistance Program, a special allowance has been granted for a specific period of time and the allowance has terminated or expired. This applies if the individual was notified in writing at the time of initiation that the allowance will automatically terminate at the end of the specified period.

K. When changes in either state or federal laws (e.g., Social Security increases) require automatic adjustments for classes of recipients.

These mass change notices will be timely and adequate. An adequate notice must include a statement of the:

1. Intended action

2. Reasons for such intended action

3. Specific change in law

4. Circumstances under which a hearing may be obtained and assistance continued

The notices will also include:

1. The specific change in the individual's benefits

2. A name and telephone number of a person to call for additional information

3. The liability a food stamp household will incur for any overissued food benefits if a fair hearing decision is adverse to the household

**History**
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 1343 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 568 (01/01/18)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 879 (05/01/18)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *10 DE Reg. 1703 (05/01/07)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *8 DE Reg. 351 (8/1/04)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 1339 (03/01/12)*
- *15 DE Reg. 1339 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 86 (07/01/11*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *14 DE Reg. 618 (01/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*

##### **16 Del. Admin. Code § 5000-5303** Reserved {#sec-5000-5303 omnilex-key=us-de-regs-official--title-16--5000-5303}

**History**
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 1343 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 568 (01/01/18)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 879 (05/01/18)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *10 DE Reg. 1703 (05/01/07)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *8 DE Reg. 351 (8/1/04)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 1339 (03/01/12)*
- *15 DE Reg. 1339 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 86 (07/01/11*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *14 DE Reg. 618 (01/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*

##### **16 Del. Admin. Code § 5000-5304** Presiding Over Fair Hearings {#sec-5000-5304 omnilex-key=us-de-regs-official--title-16--5000-5304}

7 CFR 273.15, 42 CFR 431.241, 45 CFR 205.10

This policy applies to applicants and recipients for any public assistance program administered by the Division of Social Services or the Division of Medicaid and Medical Assistance. It also applies to programs administered by other agencies over which DSS has authority. Staff may not limit or interfere in any way with an appellant’s freedom to make a request for a hearing.

1. DSS Hearing Officers Preside Over Fair Hearings

The Division of Social Services is authorized to preside over and render decisions in the following types of hearings:

A. PASRR Hearings

B. Medicaid Managed Care Cases

C. Emergency Assistance Services Hearings

D. Jurisdiction for Hearings over Medicaid Program Services

2. Hearing Officer Determines if Hearing Request is Valid

A request for a hearing must be a clear, written expression to the effect that the appellant wants the opportunity to present his or her case to a higher authority. The request must be signed by the appellant or his or her representative.

Exception: The agency must establish procedures that permit an individual, or an authorized representative, to submit a hearing request for Medical Assistance:

1. Via the internet website;

2. By telephone;

3. Via mail;

4. In person; and

5. Through other commonly available electronic means.

Appellants of actions taken in the Food Supplement Program may request a fair hearing orally. If an oral request is made, inform the appellant that it is advisable to finalize the request by putting it in writing. The staff member receiving an oral request will take steps to begin the hearing process. This includes an offer, at the time of the request, to assist the appellant by putting the request in writing.

3. Hearing Officer Limits Issues Presented at the Hearing

The Hearing Officer has the authority to restrict the issues raised at the hearing. The following issues may be raised at the hearing.

A. Issues described in the notice of action sent to the appellant

B. Issues fairly presented in the appellant's request for a hearing

C. Issues fairly presented in the Division's response in its hearing summary.

5304.1 Presiding Over PASRR Hearings

This policy applies to applicants for and recipients of residential nursing services.

Individuals adversely affected by determinations made by the Division of Substance Abuse and Mental Health (DSAMH) or the Division of Developmental Disabilities Services (DDDS) as a result of a pre-admission screening resident review PASRR may appeal the decision to the Division of Social Services (DSS). The hearing is conducted by DSS and the decision is binding on the Department of Health and Social Services.

For hearings on PASRR determinations which have a specific effect on Medicaid Program eligibility, DMMA will appear as a witness for DDDS or DSAMH if requested by a party to the hearing. Final PASRR determinations will be issued by DMMA.

For appeals initiated by non-Medicaid claimants or appellants, the State's case is presented by DDDS or by DSAMH as appropriate.

5304.2 Reserved

5304.3 Presiding Over DMMA Managed Care Hearings

42 CFR 438.408(f), 42 CFR 438.410

This policy applies to recipients enrolled in a managed care organization.

Recipients of medical services from the Division of Medicaid and Medical Assistance may request a hearing from the Division after receiving an MCO’s notice of appeal resolution upholding an adverse benefit determination or the MCO’s failure to adhere to the notice and timing requirements in 42 CFR 438.408. The decision of the DSS Hearing Officer is a final decision of the Department of Health and Social Services and is binding on the MCO.

The MCO is responsible for the preparation of the hearing summary under §5312 of these rules and the presentation of its case. The MCO is subject to the rules, practices, and procedures detailed herein.

These rules do not prevent an MCO from offering conciliation services or one level of appeal prior to the fair hearing conducted by DSS.

1. Recipients Are Entitled to an Expedited Resolution in Cases of Emergency

The MCO is responsible for establishing and maintaining an expedited review process for appeals when the MCO determines or the provider indicates that taking the time for standard resolution could seriously jeopardize the claimant’s life, physical or mental health or ability to attain, maintain, or regain maximum function. The expedited review can be requested by the claimant or the provider on the claimant’s behalf.

The MCO must provide for prompt access to MCO case records as specified in DSSM 5403. The MCO must also issue an expedited resolution within 72 hours after receiving the appeal. Expedited appeals must otherwise follow all other standard appeal requirements.

If the MCO denies a request for an expedited resolution of an appeal, it must:

i. resolve the appeal within the standard time frame of 30 days.

ii. make reasonable efforts to provide prompt oral notice of the denial and provide written notice of the denial to the claimant within 2 calendar days and inform the recipient of the right to file a grievance if he or she disagrees with that decision.

5304.4 Presiding Over Emergency Assistance Services Hearings

45 CFR 205.10(a)(1)

This policy applies to applicants for and recipients of Emergency Assistance Services. The Division of Social Services (DSS) is the appointed authority for Emergency Assistance Services (EAS). The program is administered by a contracted vendor. Requests for hearings on EAS eligibility decisions made by the contracted vendor are heard by DSS.

5304.5 Presiding Over HCBS Hearings

This policy applies to applicants and recipients of home and community-based services provided under Delaware Medicaid Program waiver projects and managed by other Divisions within the Department of Health and Social Services.

1. DSS Has Jurisdiction For Hearings Over Disputes Involving HCBS Services

The Division taking the action in dispute is responsible for the preparation of the hearing summary under §5312 of these rules and the presentation of its case. The Division is subject to the rules, practices, and procedures detailed herein. The decision of the DSS Hearing Officer is a final decision of the Department of Health and Social Services and is binding on the Division.

**History**
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 1343 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 568 (01/01/18)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 879 (05/01/18)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *10 DE Reg. 1703 (05/01/07)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *8 DE Reg. 351 (8/1/04)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 1339 (03/01/12)*
- *15 DE Reg. 1339 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 86 (07/01/11*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *14 DE Reg. 618 (01/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*

##### **16 Del. Admin. Code § 5000-5305** Limiting the Amount of Time to Request a Hearing {#sec-5000-5305 omnilex-key=us-de-regs-official--title-16--5000-5305}

7 CFR 273.15 (g), 42 CFR 431.221, 45 CFR 205.10, 42 CFR 438.408(f)

This policy applies any time an applicant or recipient of any program managed or administered by DSS or DMMA requests a fair hearing.

1. Hearing Office Staff Determine Timely Requests

An appeal (hearing request) is filed when it is received and filed in the Division's hearing office, not at the moment it is placed in the mail. Staff taking oral requests will assure the appeal is filed within the time frames in this section. Timely requests are determined based on four time periods:

A. Within the timely notice period

B. Within 90 days from the effective date of action

C. More than 90 days from the effective date of action

D. For Food Supplement Program households, at any time within a certification period,

E. For recipients enrolled in a MCO, 120 days from the date of the MCO's notice of resolution of the appeal or the MCO's failure to adhere to the notice and timing requirements in 42 CFR 438.408.

A. Timely Notice Period

Requests made during the timely notice period are timely. The timely notice period is the ten (10) day period between the dates a notice is mailed to the date a proposed action is to take effect. It is also called Advance Notice Period.

Staff will not reduce or terminate benefits pending a decision on the appeal if a request for a hearing is filed within the timely notice period.

Exception: Benefits may be reduced or terminated if the conditions in DSSM 5308 are met.

B. Ninety Days from the Effective Date of Action

A hearing is granted if the request is received within 90 days from the effective date of action. If the request is not received during the timely notice period, the proposed action must take effect.

C. More than Ninety Days from the Effective Date of Action

The hearing officer does not have authority to hear an appeal that is filed more than 90 days from the effective date of action. The hearing officer does not have authority to extend the time period beyond 90 days of the effective date of action.

D. Food Supplement Program Households

At any time within a certification period, a Food Supplement Program household may request a hearing to dispute its current level of benefits.

E. Recipients enrolled in a MCO

A hearing is granted if the request is received within 120 calendar days from the date of the MCO's notice of an appeal resolution upholding an adverse benefit determination. If the request is not received during the timely notice period, the adverse benefit determination is to take effect. If the MCO fails to adhere to the notice and timing requirements in 42 CFR 438.408, the recipient is deemed to have exhausted the MCO's appeals process and may initiate a State fair hearing within 120 calendar days.

**History**
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 1343 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 568 (01/01/18)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 879 (05/01/18)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *10 DE Reg. 1703 (05/01/07)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *8 DE Reg. 351 (8/1/04)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 1339 (03/01/12)*
- *15 DE Reg. 1339 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 86 (07/01/11*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *14 DE Reg. 618 (01/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*

##### **16 Del. Admin. Code § 5000-5306** Types of Hearings {#sec-5000-5306 omnilex-key=us-de-regs-official--title-16--5000-5306}

1) Group hearings ‑ A series of individual requests for a hearing may be consolidated into a single group hearing when the sole issue involved is one of State of federal law, regulation, or policy. In all group hearings the policies governing hearings will be followed. The individual appellant in a group hearing will be permitted to present his/her case or be represented by an authorized representative.

2) Individual hearing ‑ The majority of hearings will be of this type in which an individual client disagrees with the action taken by the Department on the facts of his/her case.

**History**
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 1343 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 568 (01/01/18)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 879 (05/01/18)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *10 DE Reg. 1703 (05/01/07)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *8 DE Reg. 351 (8/1/04)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 1339 (03/01/12)*
- *15 DE Reg. 1339 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 86 (07/01/11*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *14 DE Reg. 618 (01/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*

##### **16 Del. Admin. Code § 5000-5307** Dismissing a Hearing Request {#sec-5000-5307 omnilex-key=us-de-regs-official--title-16--5000-5307}

7 CFR 273.15 (j), 42 CFR 431.223, 45 CFR 205.10 (a)(5)(v), 42 CFR 438.408(f)

This policy applies any time a request for a hearing is filed over which the DSS Hearing Office has jurisdiction.

The hearing officer of the Division will dismiss or deny a request for a fair hearing where:

A. It has been withdrawn by the appellant in writing;

B. The sole issue is one of State or federal law requiring automatic benefit adjustments for classes of TANF, GA, Child Care or Medicaid/Medical Assistance recipients (unless the reason for an individual appeal is incorrect grant computation);

C. The appellant has abandoned his or her request by failing without good cause, to appear by him/herself or by an authorized representative at a scheduled hearing.

1. Good cause for failure to appear at a hearing may include, but is not limited to the following:

i. Death in the family;

ii. Personal injury or illness;

iii. Sudden and unexpected emergencies;

iv. Failure to receive the hearing notice.

2. The request is not received within the specified 90 day time period.

3. For recipients enrolled in a MCO the request is not received within 120 calendar days from the date of the MCO's notice of an appeal resolution upholding an adverse benefit determination or the MCO's failure to adhere to the notice and timing requirements in 42 CFR 438.408.

The hearing officer will notify both the appellant and the agency if a request for a hearing is dismissed.

**History**
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 1343 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 568 (01/01/18)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 879 (05/01/18)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *10 DE Reg. 1703 (05/01/07)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *8 DE Reg. 351 (8/1/04)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 1339 (03/01/12)*
- *15 DE Reg. 1339 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 86 (07/01/11*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *14 DE Reg. 618 (01/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*

##### **16 Del. Admin. Code § 5000-5308** Reducing or Terminating Benefits {#sec-5000-5308 omnilex-key=us-de-regs-official--title-16--5000-5308}

This policy applies any time a recipient requests a fair hearing and it is received within the timely notice period.

1. Staff Will Not Change Benefit Levels Until a Hearing Decision is Made

DSS and DMMA staff will not suspend, reduce, discontinue, or terminate assistance until a decision is reached after a fair hearing, if the request is received within the timely notice period.

Benefits are subject to recovery by the agency if its action is upheld by the hearing officer.

2. Staff May Adjust Benefit Levels Under Some Circumstances

DSS and DMMA staff will suspend, reduce, discontinue, or terminate assistance before a decision is reached after a fair hearing if:

A. The recipient specifically requests reduction or discontinuance,

B. The certification period of a Food Supplement Program household is expired;

C. A determination is made by a hearing officer at a hearing and the Food Supplement Program household is promptly informed in writing that the sole issue is one of State or federal law or regulation and that a household's claim that the State agency improperly computed the benefits or misinterpreted or misapplied such law or regulation is invalid;

D. A change affecting a Food Supplement Program household's eligibility or benefit amount occurs while the hearing decision is pending and the recipient fails to request a hearing after the subsequent notice of adverse action;

E. A change affecting the individual's TANF or other grant occurs while the hearing decision is pending and the individual fails to request a hearing after notice of the change;

F. A mass change affecting a Food Supplement Program household's eligibility or basis of issuance occurs while the hearing decision is pending;

G. A Food Supplement Program household specifically waives a continuation of benefits.

**History**
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 1343 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 568 (01/01/18)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 879 (05/01/18)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *10 DE Reg. 1703 (05/01/07)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *8 DE Reg. 351 (8/1/04)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 1339 (03/01/12)*
- *15 DE Reg. 1339 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 86 (07/01/11*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *14 DE Reg. 618 (01/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*

##### **16 Del. Admin. Code § 5000-5309** Taking Timely Action on Food Benefit Hearings {#sec-5000-5309 omnilex-key=us-de-regs-official--title-16--5000-5309}

7 CFR 273.15(c)

This policy applies any time an applicant or recipient requests a hearing involving food benefits.

1. Staff Take Timely Action on Hearing Requests

Within 60 days of receipt of a request for a fair hearing, the agency will conduct the hearing, reach a decision, and notify the household of the decision.

A. Decisions which result in an increase in household benefits

Staff will provide the additional benefits within 10 days of the receipt of the hearing decision.

However, the Division may take longer than 10 days if it elects to make the decision effective in the household's normal issuance cycle. That issuance must occur within 60 days from the date of the household's request for the hearing.

B. Decisions which result in a decrease in household benefits

Staff will decrease benefits effective with the next scheduled issuance following receipt of the hearing decision.

2. Households May Ask to Postpone the Hearing

The household may request and receive a postponement or continuance of the scheduled hearing. The hearing may not be postponed more than 30 days.

When a hearing is postponed the time limit for action on the decision is extended for as many days as the hearing is postponed. For example, if a hearing is postponed by the household for 10 days, notification of the hearing decision will be required within 70 days from the date of the original request for a hearing.

3. The State Agency May Ask to Postpone the Hearing

The agency may request that a hearing be rescheduled. The postponement is at the discretion of the hearing officer.

Any agency initiated postponement will not affect the time within which the decisions must be made and the household notified unless the hearing officer advises the agency and household to the contrary.

Unlike postponements initiated by the household, there is no extension of the 60 day timeframe when the rescheduling is at the request of the agency.

15 DE Reg. 86 (07/01/11)

**History**
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 1343 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 568 (01/01/18)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 879 (05/01/18)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *10 DE Reg. 1703 (05/01/07)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *8 DE Reg. 351 (8/1/04)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 1339 (03/01/12)*
- *15 DE Reg. 1339 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 86 (07/01/11*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *14 DE Reg. 618 (01/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*

##### **16 Del. Admin. Code § 5000-5310** Offering Applicants and Recipients A Clarification Conference {#sec-5000-5310 omnilex-key=us-de-regs-official--title-16--5000-5310}

7 CFR 273.15(d)

This policy applies to any applicant who is denied expedited food benefits. It may also apply to recipients of other programs who are adversely affected by an agency action.

1. Staff Must Offer a Clarification Conference for Expedited Households

The agency must offer the Food Supplement Program household an agency conference if the household wants to contest a denial of expedited service under DSSM 9041.

A conference may not delay or be used as a substitute for a hearing.

2. Staff May Offer a Clarification Conference for Other Households

A conference may be offered to a recipient of any program who is adversely affected by an agency action.

A conference may not delay or be used as a substitute for a hearing.

3. Staff Will Quickly Schedule a Clarification Conference

An agency conference for households contesting a denial of Food Supplement Program expedited services must be scheduled within 2 working days unless the household:

A. Requests that the conference be scheduled later, or

B. States that it does not wish to have a conference.

4. Hearing Officer Presides Over Clarification Conference

A conference may be presided over by the hearing officer or by another person designated by the hearing officer for that purpose. The conference may be conducted in person or by telephone. As a result of a conference, the hearing officer may enter an order controlling the course of the proceedings or implementing any settlement agreement.

5. State Staff are Required at Clarification Conference

An eligibility supervisor and the appellant and/or a representative are required participants at the conference. The eligibility worker or staff person responsible for the action or decision are optional participants.

**History**
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 1343 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 568 (01/01/18)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 879 (05/01/18)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *10 DE Reg. 1703 (05/01/07)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *8 DE Reg. 351 (8/1/04)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 1339 (03/01/12)*
- *15 DE Reg. 1339 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 86 (07/01/11*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *14 DE Reg. 618 (01/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*

##### **16 Del. Admin. Code § 5000-5311** Notifying Appellants and Others of Hearings {#sec-5000-5311 omnilex-key=us-de-regs-official--title-16--5000-5311}

45 CFR 205.10(a)(8), (a)(13)(i)

This policy applies to applicants and recipients of any public assistance program administered by the Division of Social Services (DSS) or the Division of Medicaid and Medical Assistance (DMMA).

1. Hearings Are Made Accessible to the Appellant

The Hearing Office will arrange the time, date, and place of the hearing so that it is accessible to the appellant.

2. Hearing Office Provides Advance Notice

The Hearing Office will mail written notice to all parties involved at least 12 days before the hearing.

Exception: An appellant may request less notice in order to speed up the scheduling of the hearing.

3. Hearing Notice is Specific

The hearing notice will:

A. Inform the appellant or representative of the name, address, and phone number of the person to notify if it is not possible for the appellant to attend the scheduled hearing;

B. Stipulate that the hearing request will be dismissed if the appellant or his or her representative fails to appear for the hearing without good cause (e.g., death in family, personal illness, unexpected emergency);

C. Include the hearing procedures and any other information that would provide the appellant with an understanding of the proceedings that would contribute to the effective presentation of the household's case. It will also include the fair hearing summary and documents filed for the hearing;

D. Explain that the appellant has the right to bring an attorney or other representative to his or her hearing;

E. Explain that the appellant may present any information that he or she desires at the hearing;

F. Explain that the appellant or representative may examine the agency and/or MCO case record prior to or during the hearing.

**History**
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 1343 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 568 (01/01/18)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 879 (05/01/18)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *10 DE Reg. 1703 (05/01/07)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *8 DE Reg. 351 (8/1/04)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 1339 (03/01/12)*
- *15 DE Reg. 1339 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 86 (07/01/11*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *14 DE Reg. 618 (01/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*

##### **16 Del. Admin. Code § 5000-5312** Responding to Fair Hearing Requests {#sec-5000-5312 omnilex-key=us-de-regs-official--title-16--5000-5312}

This policy applies anytime anyone requests a fair hearing due to a decision made by the Division of Social Services (DSS) or the Division of Medicaid and Medical Assistance (DMMA) for a program administered by DSS or DMMA.

1. The Agency Prepares a Hearing Summary

Within 5 working days of receipt of a request for a fair hearing, the agency (or MCO or other Contractor) will prepare a hearing summary and submit the summary to the Hearing Office.

Exception: For expedited hearings see DSSM 5304.3.

2. Staff Ensure the Summary Contains Pertinent Information

The hearing summary will contain enough information for the appellant to prepare his or her case. The summary must contain:

A. Identifying information - Give the client's name, the client's address, and the DCIS identification number.

B. Action taken – Indicate the basis of the client's appeal (rejection, reduction, closure, amount of benefits, etc.)

C. Reason for action - Describe the specific action taken by the agency, as well as the factual basis for its decision.

D. Has assistance continued? - Indicate whether or not the appellant's assistance was restored because the appellant filed a request for a hearing within the timely notice period.

E. Policy basis - Cite the specific State and federal rules supporting the action taken.

F. Persons expected to testify - This section lists the names and addresses (if any) of persons that the agency expects to call to testify.

3. The Hearing Office Notifies the Appellant

Upon receipt of the hearing summary, the Hearing Office will:

A. Set a prompt date for the hearing.

B. Send a notice conforming to the requirements of §5311. The notice will include the hearing summary.

C. Notify all parties, including witnesses, of the date, time, and place of the hearing.

**History**
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 1343 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 568 (01/01/18)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 879 (05/01/18)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *10 DE Reg. 1703 (05/01/07)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *8 DE Reg. 351 (8/1/04)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 1339 (03/01/12)*
- *15 DE Reg. 1339 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 86 (07/01/11*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *14 DE Reg. 618 (01/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*

##### **16 Del. Admin. Code § 5000-5400** Establishing Fair Hearing Requirements {#sec-5000-5400 omnilex-key=us-de-regs-official--title-16--5000-5400}

This policy applies to State/Agency staff and Hearing Officers any time a fair hearing is held.

1. DSS Assures the Fair Hearing Requirements are Met

Each fair hearing will be held under the following conditions:

A. The hearing will be held at a reasonable time, date, and place;

B. The hearing officer will be an impartial official and may not have been previously involved with the matters raised at the hearing outside his duties as hearing officer. This section will not prevent the hearing officer from rehearing a matter which has been remanded or hearing a case which may be related to prior cases with which he had contact in his capacity as hearing officer;

C. If the hearing involves medical issues such as those concerning a diagnosis, an examining physician's report or a medical review team's decision, a medical assessment other than that of the person or persons involved in making the original decision may be obtained at agency expense and may be made part of the record at the discretion of the hearing officer;

D. The hearing will be conducted in an orderly manner in order to assure that an adequate record of the proceedings is maintained;

E. Witnesses for the State or agency shall be prepared to present the reason for the action and the applicable rules in an orderly and concise manner;

F. When records are used as evidence, originals and legible copies of all documentation shall be provided for the hearing officer's record;

G. Only evidence presented at the hearing shall be considered by the hearing officer in reaching his decision;

H. A complete and exact record of the proceedings shall be made by electronic means. (When required, DSS will provide a transcript of the proceedings.)

I. The hearing clerk shall have custody of the records and papers of the hearing. The clerk shall not permit any original record or paper to be taken unless authorized to do so by the hearing officer. Original papers transmitted as the record on appeal or review shall upon disposition of the case be returned to the person or agency from which they were received. The clerk shall preserve copies of hearing records consistent with any State rule of records management.

15 DE Reg. 86 (07/01/11)

**History**
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 1343 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 568 (01/01/18)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 879 (05/01/18)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *10 DE Reg. 1703 (05/01/07)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *8 DE Reg. 351 (8/1/04)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 1339 (03/01/12)*
- *15 DE Reg. 1339 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 86 (07/01/11*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *14 DE Reg. 618 (01/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*

##### **16 Del. Admin. Code § 5000-5401** Conducting Hearings on State Actions {#sec-5000-5401 omnilex-key=us-de-regs-official--title-16--5000-5401}

7 CFR 7 CFR 271.7 (f) 7 CFR 273.15 (a), 42 CFR 431.220, 45 CFR 205.10 (a)(5)

This policy applies to DSS hearing officers any time an appellant/claimant requests a hearing due to an agency action.

1. Hearing Officers Conduct Hearings on Agency Actions

A. Food Supplement Program Hearings

DSS will provide a fair hearing to any household aggrieved by any action of the State agency which affects the participation of the household in the Program.

Exception: DSS is not required to hold fair hearings unless the request for a fair hearing is based on a household's belief that:

A. Its benefit level was computed incorrectly

B. The rules were misapplied or misinterpreted

Exception: DSS may deny fair hearings to those households who are merely disputing the fact that a reduction, suspension or cancellation was ordered as a result of an order issued by the Food and Nutrition Service.

B. Cash Assistance and Child Care Hearings

Upon request, a hearing will be held when:

1. An applicant’s claim for services is denied or is not acted upon with reasonable promptness.

2. An applicant’s claim for financial assistance is denied.

3. A recipient is aggrieved by any agency action resulting in suspension, reduction, discontinuance, or termination of assistance.

4. A recipient is aggrieved by any agency action resulting in a determination that a protective, vendor, or two-party payment should be made or continued.

Exception: The agency does not have to grant a hearing when either State or Federal law requires automatic grant adjustments for classes of recipients unless the reason for an individual appeal is incorrect grant computation

C. Medical Assistance Hearings

The State agency must grant an opportunity for a hearing when:

1. An applicant’s claim for services is denied or is not acted upon with reasonable promptness.

2. A recipient believes the agency has taken an action erroneously.

3. A resident believes a nursing facility has erroneously determined that he or she must be transferred or discharged.

4. An individual believes the State has made an erroneous PASRR determination.

5. A hearing request is received from any prepaid ambulatory health plan (PAHP) enrollee who is entitled to a hearing under 42 CFR 431 subpart E.

6. A hearing request is received from any managed care organization (MCO) or prepaid inpatient health plan (PIHP) enrollee who is entitled to a hearing under 42 CFR 438 subpart F.

7. A hearing request is received from any enrollee who is entitled to a hearing under 42 CFR 438 subpart B.

Exception: The agency need not grant a hearing if the sole issue is a Federal or State law requiring an automatic change adversely affecting some or all recipients.

**History**
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 1343 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 568 (01/01/18)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 879 (05/01/18)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *10 DE Reg. 1703 (05/01/07)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *8 DE Reg. 351 (8/1/04)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 1339 (03/01/12)*
- *15 DE Reg. 1339 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 86 (07/01/11*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *14 DE Reg. 618 (01/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*

##### **16 Del. Admin. Code § 5000-5402** Conducting Hearings on Agency Decisions {#sec-5000-5402 omnilex-key=us-de-regs-official--title-16--5000-5402}

This policy applies to DSS hearing officers any time an appellant/claimant requests a hearing due to an agency decision.

1. DSS Hearing Officers Conduct Hearings Regarding Agency Decisions

The Hearing Officer will conduct hearings regarding decisions on:

A. Eligibility for financial or medical assistance

B. The amount of financial or medical assistance

Exception: A Food Supplement household may dispute its current level of food benefits at any time

C. The manner or form of the benefit

D. A decision of a MCO or other contractor that a medical service, treatment or test is not medically or otherwise necessary

E. A denial of a request for restoration of food benefits lost more than 90 days but less than one year prior to the request

F. Expedited service in the Food Supplement Program.

**History**
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 1343 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 568 (01/01/18)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 879 (05/01/18)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *10 DE Reg. 1703 (05/01/07)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *8 DE Reg. 351 (8/1/04)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 1339 (03/01/12)*
- *15 DE Reg. 1339 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 86 (07/01/11*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *14 DE Reg. 618 (01/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*

##### **16 Del. Admin. Code § 5000-5403** Providing Documents to Appellants {#sec-5000-5403 omnilex-key=us-de-regs-official--title-16--5000-5403}

45 CFR 205.10(13), 7 CFR 273.15(p)(1), 42 CFR 431.242

This policy applies anytime an appellant or his or her representative requests a fair hearing.

1. Appellants May Examine Case Records and Documents

Prior to the hearing, the appellant and his or her representative will have adequate opportunity to examine all documents and records to be used by the State agency or its agent at the hearing. He or she may also examine his or her case records.

2. Staff Must Provide Case Records in a Timely Manner

Staff must make case records available to the appellant within 5 working days of the request. If copies of documents are requested for the hearing, they will be provided at no cost. For expedited resolution requests, case records must be made available within 1 working day of the receipt of the appeal.

Exception: Staff must not release confidential information, such as

1. the names of individuals who have disclosed information about the household without its knowledge

2. the nature or status of pending criminal prosecutions

**History**
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 1343 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 568 (01/01/18)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 879 (05/01/18)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *10 DE Reg. 1703 (05/01/07)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *8 DE Reg. 351 (8/1/04)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 1339 (03/01/12)*
- *15 DE Reg. 1339 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 86 (07/01/11*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *14 DE Reg. 618 (01/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*

##### **16 Del. Admin. Code § 5000-5404** Providing Options to Appellants at Hearings {#sec-5000-5404 omnilex-key=us-de-regs-official--title-16--5000-5404}

7 CFR 273.15(p), 42 CFR 431.242, 45 CFR 205.10(10)

This policy applies to appellants or his or her representative during a fair hearing.

At the hearing the appellant or his/her representative will have the opportunity to:

A. Examine the case records and documents;

B. Present his or her case by him/herself or with the aid of a representative or counsel;

C. Bring witnesses;

D. Submit evidence to establish all pertinent facts and circumstances;

E. Advance any argument without interference;

F. Question or refute any testimony or evidence including the opportunity to confront and cross-examine adverse witnesses;

G. Be provided with interpreters or mechanical facilities to overcome language or other communication limitations;

H. Withdraw his or her request for a hearing at any time.

**History**
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 1343 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 568 (01/01/18)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 879 (05/01/18)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *10 DE Reg. 1703 (05/01/07)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *8 DE Reg. 351 (8/1/04)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 1339 (03/01/12)*
- *15 DE Reg. 1339 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 86 (07/01/11*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *14 DE Reg. 618 (01/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*

##### **16 Del. Admin. Code § 5000-5405** RESERVED {#sec-5000-5405 omnilex-key=us-de-regs-official--title-16--5000-5405}

**History**
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 1343 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 568 (01/01/18)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 879 (05/01/18)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *10 DE Reg. 1703 (05/01/07)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *8 DE Reg. 351 (8/1/04)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 1339 (03/01/12)*
- *15 DE Reg. 1339 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 86 (07/01/11*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *14 DE Reg. 618 (01/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*

##### **16 Del. Admin. Code § 5000-5406** Powers and Duties of Hearing Officers {#sec-5000-5406 omnilex-key=us-de-regs-official--title-16--5000-5406}

7 CFR 273.15(M)(2)

This policy applies to all Hearing Officers in the conduct of their duties for the Department of Health and Social Services.

The hearing officer will:

A. Notify the parties of the date, time, and place of the hearing;

B. Take measures to avoid delays;

C. Ensure a fair and impartial proceeding;

D. Explain the hearing procedures;

E. Administer an oath or affirmation to all witnesses;

F. Ensure that all relevant issues are considered;

G. Maintain order and decorum;

H. Request, receive, and make part of the record all evidence determined to be necessary to decide the issues raised for the hearing;

I. Examine witnesses when necessary to develop the hearing record;

J. Regulate the conduct and course of the hearing to ensure an orderly hearing in a fashion consistent with due process;

K. Order, where relevant and useful, an independent medical assessment from a source mutually satisfactory to the appellant and to the agency;

L. Make a record of the hearing;

M. Provide a final hearing decision to the parties.

5406.1 Authority of Hearing Officer

1) The hearing officer shall apply the State rules except to the extent they are in conflict with applicable federal regulations. The hearing officer shall be bound by rules regarding the date of implementation or effect of changes in federal statutes. The hearing officer shall be bound by applicable precedent of the following courts in the following order: U.S. Supreme Court, 3rd Circuit Court of Appeals, District Court for the District of Delaware, Delaware Supreme Court, Delaware Chancery Court, Superior Court. The hearing officer may consider decisions of other jurisdictions on questions that are not otherwise decided under State or federal rules.

2) The hearing officer must accept a decision made by another administrative agency including when such determination is a prerequisite for eligibility for a public benefit under a program administered by the State, i.e., if the Social Security Appeals Council has decided that a client is not eligible for SSI benefits, the hearing officer must abide by such decision. However, if the decision of the other agency is not final, the hearing officer shall have latitude to reserve the right to reconsider his decision in the event the other agency's decision is altered or reversed by a higher authority.

**History**
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 1343 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 568 (01/01/18)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 879 (05/01/18)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *10 DE Reg. 1703 (05/01/07)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *8 DE Reg. 351 (8/1/04)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 1339 (03/01/12)*
- *15 DE Reg. 1339 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 86 (07/01/11*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *14 DE Reg. 618 (01/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*

##### **16 Del. Admin. Code § 5000-5407** RESERVED {#sec-5000-5407 omnilex-key=us-de-regs-official--title-16--5000-5407}

**History**
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 1343 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 568 (01/01/18)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 879 (05/01/18)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *10 DE Reg. 1703 (05/01/07)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *8 DE Reg. 351 (8/1/04)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 1339 (03/01/12)*
- *15 DE Reg. 1339 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 86 (07/01/11*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *14 DE Reg. 618 (01/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*

##### **16 Del. Admin. Code § 5000-5500** Issuing Fair Hearing Decisions {#sec-5000-5500 omnilex-key=us-de-regs-official--title-16--5000-5500}

7 CFR 273.15(c), (q); 42 CFR 431.244, 431.245; 45 CFR 205.10(16)

This policy applies to applicants and recipients of any public assistance program administered by the Division of Social Services (DSS) or the Division of Medicaid and Medical Assistance (DMMA).

1. Hearing Decisions Are Made Promptly

The Hearing Officer has sole authority to make hearing decisions. The Hearing Officer must take prompt, definitive, and final administrative action within 90 days from the date the appeal is filed. The decision must be in writing and must be sent to the appellant as soon as it is made.

Exception: Food Supplement Program decisions must be made within 60 days from the date the appeal is filed

Exception: Expedited hearing decisions for medical assistance must be made within 3 working days from receipt of the appeal which meets the criteria for an expedited appeal process. See Section 5304.3

2. Decisions Are Binding on the Department of Health and Social Services

3. Decisions Comply with Laws and Regulations

The Hearing Officer’s decision will comply with State and federal laws and regulations and are based on the hearing record.

4. Decisions Must Contain Specific Information

The written decision will contain, at a minimum, the following information.

A. Information to enable a reader to understand how the decision was reached.

B. Supporting evidence

C. Food Supplement Program cases will state whether benefits will be issued or terminated.

The decision contains:

1. A statement of the appellant's right to judicial review

2. The identity of the individual

3. A summary of evidence

4. Findings of fact

5. A discussion or analysis of facts and arguments presented at the hearing

6. A discussion of how the applicable rules apply to the facts in the case

7. The resulting conclusions

8. The hearing officer's decision and/or order

9. Applicable rules involved in reaching the decision

**History**
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 1343 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 568 (01/01/18)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 879 (05/01/18)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *10 DE Reg. 1703 (05/01/07)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *8 DE Reg. 351 (8/1/04)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 1339 (03/01/12)*
- *15 DE Reg. 1339 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 86 (07/01/11*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *14 DE Reg. 618 (01/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*

##### **16 Del. Admin. Code § 5000-5501** Making Corrective Payments or Actions {#sec-5000-5501 omnilex-key=us-de-regs-official--title-16--5000-5501}

7 CFR 273.15(s), 42 CFR 431.246, 45 CFR 205.10(a)(16)

This policy applies any time a hearing decision requires an adjustment in benefits. It also applies when an error that favors the appellant/claimant is discovered by the Division of Social Services (DSS) or the Division of Medicaid & Medical Assistance (DMMA).

1. The State Agency Initiates Corrective Actions

Staff will take corrective action (retroactive to the date an incorrect action was taken) when:

A. A hearing decision is favorable to the appellant

B. The agency decides in favor of the appellant prior to the hearing

Staff will take action to initiate the corrective payments or other remedy within 5 business days of the date of the hearing decision.

DSS or DMMA staff will restore benefits to food benefit households that are leaving the State before the household’s departure, whenever possible.

NOTE: For food benefits and cash assistance, staff must always prepare a claim against the household for any over-issuance when the hearing decision upholds the agency's action.

**History**
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 1343 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 568 (01/01/18)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 879 (05/01/18)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *10 DE Reg. 1703 (05/01/07)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *8 DE Reg. 351 (8/1/04)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 1339 (03/01/12)*
- *15 DE Reg. 1339 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 86 (07/01/11*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *14 DE Reg. 618 (01/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*

##### **16 Del. Admin. Code § 5000-5502** Providing Public Access to Hearing Decisions {#sec-5000-5502 omnilex-key=us-de-regs-official--title-16--5000-5502}

7 CFR 272.1(c), 7 CFR 273.15(q)(5), 42 CFR 431.244(g), 45 CFR 205.10(19), 45 CFR 205.50, 31 Del.C. §1101

This policy applies to all hearing decisions made by the Division of Social Services (DSS) or the Division of Medicaid & Medical Assistance (DMMA).

1. Hearing Decisions are Available to The Public

Hearing decisions are available to the public on the Division of Social Services and Division of Medicaid & Medical Assistance websites.

DSS: (http://www.dhss.delaware.gov/dhss/dss/redactedfairhearings.html)

DMMA: (http://www.dhss.delaware.gov/dhss/dmma/fairhearings.html).

2. DSS and DMMA Take Steps to Keep Identities Confidential

DSS and DMMA remove information that might identify the appellant/claimant before the decision is made available.

No information concerning applicants or recipients of public assistance is revealed except for the purposes directly connected with the administration of the program.

**History**
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 1343 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 568 (01/01/18)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 879 (05/01/18)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *10 DE Reg. 1703 (05/01/07)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *8 DE Reg. 351 (8/1/04)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 1339 (03/01/12)*
- *15 DE Reg. 1339 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 86 (07/01/11*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *14 DE Reg. 618 (01/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*

##### **16 Del. Admin. Code § 5000-5600** Admitting Hearsay Evidence {#sec-5000-5600 omnilex-key=us-de-regs-official--title-16--5000-5600}

Federal Rule of Evidence 803, Delaware Uniform Rules of Evidence

This policy applies to applicants and recipients for any public assistance program administered by the Division of Social Services or the Division of Medicaid & Medical Assistance.

1. The Hearing Officer Decides if Hearsay Evidence is Admissible

Admissible hearsay evidence includes:

A. Statements where the claimant has had an opportunity to cross examine the witness at a prior proceeding

B. Statements of agency staff who could be available as witnesses upon a claimant's request

C. Evidence which falls within recognized hearing exceptions where cross-examination of the witness would not be meaningful

D. Official records of the Department of Health and Social Services and other official records when authenticated by a custodian of the record

E. Evidence recognized by official notice as an exception to the hearsay rule (see DSSM 5603)

Exception: Recognized exceptions to the hearsay rule include:

1. Statements for purposes of medical diagnosis

2. Records of regularly conducted activity (such as Employment and Training logs)

3. Records of vital statistics

4. Records of religious organizations

5. Records of or statements in documents affecting an interest in property

See Delaware Uniform Rules of Evidence §803 for more exceptions.

2. Hearsay Evidence is Not Admissible if There is an Objection

If a party to the hearing objects to the use of hearsay evidence, the evidence will not be admitted.

Exception: Hearsay evidence is admissible, regardless of objections, if it meets one of the exceptions to the hearsay rule listed in the Delaware Uniform Rules of Evidence.

5600.1 Admitting Evidence

45 CFR 205.10(14)

This policy applies to applicants and recipients for any public assistance program administered by the Division of Social Services or the Division of Medicaid & Medical Assistance.

1. Hearing Officer Determines if Evidence is Admissible

Evidence must meet the following minimum criteria to be admissible.

A. Relevance - In order for evidence to be admissible in a fair hearing it must be relevant. Evidence is relevant if an average person believes that the evidence makes a significant fact more probable.

B. Reliability - In order for evidence to be admissible in a fair hearing it must be reliable.

C. Competence - In addition to relevance and reliability, evidence admitted at a hearing must be competent.

D. Privilege - Appellants may decline to present testimony or evidence at a fair hearing under claim of privilege.

Privilege may include the privilege against self-incrimination or communication to an attorney, a religious advisor, or doctor.

Exception: Privilege may not be disclosed without the consent of the person who sought the professional assistance unless:

1. It has been waived

2. The person attempting to claim it has put the subject of the privilege at issue in the fair hearing

1. Claimants or Witnesses May Waive Privilege

Privileges are waived by a claimant or witness if he or she testifies to some part of the privileged matter.

EXAMPLE: A person who makes his or her medical condition an issue may not use Doctor/ Patient privileges to exclude any information relating to his or her condition.

2. Hearing Officer Limits Admissible Evidence

Only evidence relating to the issue under appeal is admissible at the hearing. Issues under appeal include those offered by:

A. The appellant at the time of his or her appeal

B. The State as a basis for the action or inaction under appeal

C. Another party as a basis for the action or inaction under appeal

3. Hearing Officer May Admit Other Evidence

Information concerning matters of common knowledge and generally accepted as true may be relied on in a fair hearing whether or not it is introduced by evidence or testimony.

The behavior of a party to a hearing may be taken by a hearing officer into evidence only when the behavior has been noted in the hearing record.

**History**
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 1343 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 568 (01/01/18)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 879 (05/01/18)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *10 DE Reg. 1703 (05/01/07)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *8 DE Reg. 351 (8/1/04)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 1339 (03/01/12)*
- *15 DE Reg. 1339 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 86 (07/01/11*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *14 DE Reg. 618 (01/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*

##### **16 Del. Admin. Code § 5000-5601** Reserved {#sec-5000-5601 omnilex-key=us-de-regs-official--title-16--5000-5601}

**History**
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 1343 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 568 (01/01/18)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 879 (05/01/18)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *10 DE Reg. 1703 (05/01/07)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *8 DE Reg. 351 (8/1/04)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 1339 (03/01/12)*
- *15 DE Reg. 1339 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 86 (07/01/11*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *14 DE Reg. 618 (01/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*

##### **16 Del. Admin. Code § 5000-5602** Reserved {#sec-5000-5602 omnilex-key=us-de-regs-official--title-16--5000-5602}

**History**
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 1343 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 568 (01/01/18)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 879 (05/01/18)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *10 DE Reg. 1703 (05/01/07)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *8 DE Reg. 351 (8/1/04)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 1339 (03/01/12)*
- *15 DE Reg. 1339 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 86 (07/01/11*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *14 DE Reg. 618 (01/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*

##### **16 Del. Admin. Code § 5000-5603** Reserved {#sec-5000-5603 omnilex-key=us-de-regs-official--title-16--5000-5603}

**History**
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 1343 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 568 (01/01/18)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 879 (05/01/18)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *10 DE Reg. 1703 (05/01/07)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *8 DE Reg. 351 (8/1/04)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 1339 (03/01/12)*
- *15 DE Reg. 1339 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 86 (07/01/11*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *14 DE Reg. 618 (01/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*

##### **16 Del. Admin. Code § 5000-5604** Discussing the Case {#sec-5000-5604 omnilex-key=us-de-regs-official--title-16--5000-5604}

This policy applies to all parties involved with a hearing for any public assistance program administered by the Division of Social Services or the Division of Medicaid & Medical Assistance.

1. Discussions About the Case Are Prohibited

A. Before the Hearing:

A party to the hearing may not discuss the merits of the case with the hearing officer.

B. After the Hearing

Agency employees may not discuss the merits of the case with the hearing officer after the hearing is adjourned.

**History**
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 1343 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 568 (01/01/18)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 879 (05/01/18)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *10 DE Reg. 1703 (05/01/07)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *8 DE Reg. 351 (8/1/04)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 1339 (03/01/12)*
- *15 DE Reg. 1339 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 86 (07/01/11*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *14 DE Reg. 618 (01/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*

##### **16 Del. Admin. Code § 5000-5605** Requesting a Continuance {#sec-5000-5605 omnilex-key=us-de-regs-official--title-16--5000-5605}

7 CFR 273.15(c)(4)

This policy applies to every appellant, appellant’s authorized agent, and agency staff involved in the hearing. It applies to any public assistance program administered by the Division of Social Services or the Division of Medicaid & Medical Assistance.

1. Either Party To A Hearing May Request A Continuance

Either party to a hearing may request that the hearing officer continue the hearing on a different date.

Exception: A witness or party in interest to the hearing may not request a continuance.

2. Requests For A Continuance Meet Specific Requirements

A request for a continuance must:

A. Should be made at least 24 hours in advance of the hearing so that the other party may be notified

B. Must specify the reason that a continuance is needed

Examples of requests for which a continuance should be granted, include, but are not limited to:

1. Illness of a party or witness

2. Extreme inclement weather

3. Request for additional time to prepare for the hearing

3. Hearing Officer Responds to Requests

The hearing officer will respond to the request not later than 10 days after the request is received.

No continuance will be granted to the State or its agent if the continuance would result in the State exceeding the time limits specified in DSSM 5305 and DSSM 5309 or any statutory time limit.

**History**
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 1343 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 568 (01/01/18)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 879 (05/01/18)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *10 DE Reg. 1703 (05/01/07)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *8 DE Reg. 351 (8/1/04)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 1339 (03/01/12)*
- *15 DE Reg. 1339 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 86 (07/01/11*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *14 DE Reg. 618 (01/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*

##### **16 Del. Admin. Code § 5000-5606** Disqualifying a Hearing Officer {#sec-5000-5606 omnilex-key=us-de-regs-official--title-16--5000-5606}

7 CFR 273.15(m), 42 CFR 431.240(a)(3), 45 CFR 205.10(a)(9)

This policy applies to every hearing officer, appellant, appellant’s authorized agent, and agency staff involved in the hearing. It applies to any public assistance program administered by the Division of Social Services or the Division of Medicaid & Medical Assistance.

1. Hearing Officer Is Impartial

The hearing officer must be impartial with no personal stake or involvement in the case. The hearing officer is prohibited from having any involvement in the initial determination of the action in question.

2. Hearing Officer May Disqualify Himself

3. Either Party May Ask to Disqualify a Hearing Officer

The appellant, the appellant’s authorized agent, or the agency employee may ask the hearing office to disqualify himself or herself from the hearing. This could happen if they believe the hearing officer has an interest in or prejudice against an issue of the hearing.

4. Hearing Officer Gives Notice of Disqualification

If a hearing officer is disqualified, the officer will immediately notify the Director of the Division of Social Services. The Director will promptly appoint a new hearing officer.

**History**
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 1343 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 568 (01/01/18)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 879 (05/01/18)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *10 DE Reg. 1703 (05/01/07)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *8 DE Reg. 351 (8/1/04)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 1339 (03/01/12)*
- *15 DE Reg. 1339 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 86 (07/01/11*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *14 DE Reg. 618 (01/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*

##### **16 Del. Admin. Code § 5000-5607** Reserved {#sec-5000-5607 omnilex-key=us-de-regs-official--title-16--5000-5607}

**History**
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 1343 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 568 (01/01/18)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *15 DE Reg. 86 (07/01/11)*
- *27 DE Reg. 975 (06/01/24)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *21 DE Reg. 879 (05/01/18)*
- *12 DE Reg. 242 (08/01/08)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *10 DE Reg. 1703 (05/01/07)*
- *15 DE Reg. 86 (07/01/11)*
- *21 DE Reg. 568 (01/01/18)*
- *8 DE Reg. 351 (8/1/04)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 1339 (03/01/12)*
- *15 DE Reg. 1339 (03/01/12)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *11 DE Reg. 1482 (05/01/08)*
- *15 DE Reg. 86 (07/01/11*
- *15 DE Reg. 86 (07/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *14 DE Reg. 618 (01/01/11)*
- *15 DE Reg. 86 (07/01/11)*
- *16 DE Reg. 419 (10/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*
- *15 DE Reg. 1343 (03/01/12)*

#### **6000** Emergency Assistance Services

##### **16 Del. Admin. Code § 6000** Purpose {#sec-6000 omnilex-key=us-de-regs-official--title-16--6000}

The purpose of Emergency Assistance is to avoid the destitution of a child or of a needy distressed resident of the State by providing payments which eliminate or alleviate an emergency condition. An emergency is caused by an unforeseen circumstance or combination of circumstances or the resulting state that calls for immediate action.

**History**
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*

##### **16 Del. Admin. Code § 6000-6001** Reserved {#sec-6000-6001 omnilex-key=us-de-regs-official--title-16--6000-6001}

**History**
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*

##### **16 Del. Admin. Code § 6000-6002** Determining Eligibility for Emergency Assistance {#sec-6000-6002 omnilex-key=us-de-regs-official--title-16--6000-6002}

Title IV §404(a)(2), 31 Del. Code §521

This policy applies to Delaware residents who are experiencing a crisis due to unforeseen circumstances. Services are provided through the Division of State Service Centers (DSSC).

1. DHSS Staff Determine Eligibility

Individuals or families must meet technical and financial eligibility criteria.

Technical Eligibility

Only the following Delaware residents may participate:

A. Individual or family receiving the following types of cash assistance:

1. Temporary Assistance for Needy Families (TANF)

2. General Assistance (GA)

3. Supplemental Security Income (SSI)

B. Individual or family receiving or eligible for the following types of Medicaid:

1. 1931 Medicaid

2. Transitional Medicaid

3. Prospective Medicaid

4. Poverty-related Pregnant Women, Infants and Children Medicaid

C. Family has children at risk of removal from their home due to abuse or neglect, or the children are suspected at risk of abuse or neglect

D. Family has children at risk of removal from the community

E. Family has children removed from their home due to abuse or neglect, or the children were suspected at risk of abuse or neglect

F. Family has children removed from the community

Financial Eligibility

A. Household Income Is Limited

Income eligibility is met if the family meets the technical eligibility criteria above.

B. Household Resources Are Limited

1. The emergency must have resulted from an unforeseen circumstance

or combination of circumstances that are beyond the recipient's control.

2. Medicaid individuals and families cannot have resources immediately accessible

to meet their needs.

3. The child cannot have resources immediately accessible to meet his or her needs,

or

a. the emergency assistance is necessary to avoid the destitution of the child, or

b. emergency assistance is necessary to provide the child living arrangements in a home.

2. DHSS Staff Limits Assistance to Recipients

This section only applies to those who are technically eligible due to receipt of cash or medical assistance as listed in Technical Eligibility above.

A. Applicants for assistance must have a qualifying emergency. A qualifying emergency is one that resulted from an unforeseen circumstance or combination of circumstances that are beyond the recipient's control.

NOTE: A recipient whose money is stolen may receive assistance if the recipient provides a police report of the incident.

DHSS will not authorize emergency assistance when the emergency was due to a recipient's failure to comply with a requirement of a Division of Social Services program. This includes individuals whose grant was reduced as the result of a sanction or disqualification.

Example:

a. Mary was sanctioned which resulted in a reduction of her TANF grant. Because she has less money she is not able to pay her electric bill. She is not eligible for emergency assistance because a grant reduction is a foreseeable consequence of a sanction.

b. Joey was disqualified which resulted in a reduction of his TANF grant. Because he has less money he is not able to pay his rent. At the same time his refrigerator breaks down. This is not a result of his disqualification (grant reduction) and Joey could be eligible for emergency assistance to repair or replace his refrigerator.

**History**
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*

##### **16 Del. Admin. Code § 6000-6003** Making Payments for Emergency Assistance Services {#sec-6000-6003 omnilex-key=us-de-regs-official--title-16--6000-6003}

31 Del.Code §521

This policy applies any time a payment is issued for Emergency Assistance Services.

1. DHSS Makes Payments to Vendors

Payments for Emergency Assistance Services are made by check directly to the vendor..

2. DHSS Limits Amounts and Frequency of Payments to Vendors

A household can receive approval for a payment from each of the following categories. Payment is limited to one period of 30 consecutive days in any twelve consecutive months.

Payments authorized within the 30-day period may cover needs which will arise during the 60 consecutive days beginning on the day after the end of the 30-day period.

Payments authorized within the 30-day period may cover debts which became due and payable within the 60 consecutive days immediately prior to the day the recipient applies for assistance.

The maximum payment a household can receive during the 30 day period is:

A. $1,200 for emergency shelter certified by the Department of Health and Social Services (DHSS)

B. $450 for mortgage or rent assistance

C. $200 for other costs related to the self-sufficiency of the household

3. Payment Limits Apply to the Original Household

The payment limitation and time restrictions apply only to the original household.

Former members of a household that received emergency assistance may themselves receive assistance if they had not requested funds while part of the original household. For example, a household (F1) contains two TANF cases (A1) and (A2).

A1 receives emergency assistance to purchase a refrigerator in July. In September A2 moves to her own apartment. Several months later in December A2 needs money to pay the rent because her money was stolen. A2 can receive help because she is no longer part of the F1 household and while part of the F1 household had not requested assistance. If A1 asked for help, A1 would be denied because A1 received an emergency assistance payment less than twelve months ago.

**History**
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*

##### **16 Del. Admin. Code § 6000-6004** Reserved {#sec-6000-6004 omnilex-key=us-de-regs-official--title-16--6000-6004}

**History**
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*

##### **16 Del. Admin. Code § 6000-6005** Providing Assistance for Qualified Emergencies {#sec-6000-6005 omnilex-key=us-de-regs-official--title-16--6000-6005}

31 Del. Code §521

This policy applies after applicants are determined eligible for Emergency Assistance services.

1. Emergency Assistance is Provided for Qualified Emergencies

Recipients with an emergency as defined in DSSM 6000 and who meet the eligibility criteria in DSSM 6002 are eligible to receive emergency assistance.

The covered items and the conditions that must be present before payments can be authorized are listed below.

A. Home repairs

The repair must be needed to assure adequate heating, refrigeration, cooking facilities, and water supplies.

B. Shelter expense

The recipients must be homeless or in jeopardy of losing their home. They cannot be more than 60 days behind in making payments on rent or mortgage or property taxes.

A maximum of $1,200 is allowed to provide a homeless recipient with up to 90 consecutive days of temporary emergency shelter in a DHSS certified shelter.

A maximum of $650 is allowed to help a recipient:

a. Secure permanent shelter

b. Maintain existing shelter

c. Transition from temporary emergency shelter to secure permanent shelter

1. Temporary emergency shelter

i. DHSS will authorize temporary emergency shelter in a DHSS certified shelter that meets the recipient's needs. DHSS will not count cash assistance received or money counted to determine the amount of cash assistance when authorizing temporary shelter.

ii. DHSS will authorize the maximum time and amount allowed for temporary emergency shelter unless the recipient refuses to:

a. Relocate to subsequently arranged temporary emergency shelter in a free shelter

b. Actively seek permanent housing and cooperate with DHSS in monitoring progress of the housing search

Cooperation with the housing search requires the recipient to:

i. Contact DHSS at least weekly at mutually agreed upon times by telephone or arranged office appointment

ii. Make housing contacts

iii. Keep appointments

iv. Discuss progress with the worker

Failure to cooperate without good cause (e.g., illness of recipient or immediate family member, no viable contacts remaining) will result in termination of the recipient's authorization for temporary emergency shelter

iii. DHSS will not authorize temporary emergency shelter if free or permanent shelter is available or was refused without good cause.

Good cause includes the need for a family member to remain in a school district or near an employer when public or private transportation is not reasonably available.

iv. The recipient has the primary responsibility for seeking and securing permanent shelter.

2. Permanent shelter

Recipients must be able to maintain ongoing permanent shelter costs in order to receive help toward permanent shelter. Assistance can be used to pay up to two months' arrearage or the first month's rent and/or security deposit. See DSSM 6003 for amounts and limitations.

C. Moving expenses

The move must be necessitated by a crisis situation such as fire, eviction or condemnation of a house. The applicant must provide estimates before payments can be authorized.

D. Household appliances and home furnishings

The appliance or furnishing must be needed to assure adequate heating, refrigeration, and cooking facilities, and to provide appropriate sleeping arrangements. Funds may be used to purchase new items or replace existing items.

E. Medical needs

A medical need is present if that need could result in serious impairment of health, prolonged hospitalization, or death.

F. Fuel and utility bills

The recipient must have an unpaid bill which became due and payable within 60 consecutive days immediately prior to the day the recipient applies for assistance. The recipient must be in immediate jeopardy of having his or her service disconnected or be unable to purchase fuel to maintain adequate living conditions. Recipients who have applied for funds under the Energy Crisis Assistance Program (ECAP) are eligible for assistance only when a delay in receiving ECAP funds will cause a hardship.

G. Food expenses

A food need is present that could result in hunger in spite of the expedited service requirements of the Food Supplement Program. Households eligible for expedited service must receive their food benefits within 7 calendar days following the date the application was filed.

Payments for food expense are limited as follows

1 person

$20.00

2 - 4 persons

$27.00

5 - 7 persons

$33.00

8 - 10 persons

$40.00

11 or more persons

$53.00

H. Clothing

Assistance for clothing is authorized only if the need results from fire or theft and there is no other resource available.

I. Transportation

Costs are allowed only when:

a. The consequences arising out of the emergency demand that transportation be provided to the client in order to improve the situation

b. Free transportation is not available, such as, transportation under Title XIX

**History**
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*

##### **16 Del. Admin. Code § 6000-6006** Offering Emergency Assistance Services {#sec-6000-6006 omnilex-key=us-de-regs-official--title-16--6000-6006}

This policy applies to any staff assigned to provide emergency assistance services.

Emergency Assistance Staff Offer Specific Services

Emergency assistance staff will offer at least the following services, as required.

A. In personal and family crisis situations:

1. Provide casework or counseling service

2. Arrange for emergency financial assistance, if necessary

3. Provide other services required because of the nature of the emergency situation

B. In medical crisis situations:

1. Obtain the services of a physician for a client

2. Arrange for the care of dependents

3. Assist in obtaining other services and assistance, such as medical diagnosis treatment, care in appropriate settings

C. In housing and maintenance crisis situations:

1. Secure temporary shelter, utilities, food, clothing, and other maintenance items for the duration of the emergency

2. Refer applicants to appropriate agencies for assistance in obtaining permanent living arrangements appropriate to the client and his/her dependents after they leave a temporary shelter

3. Provide necessary replacement of lost household furniture, equipment and supplies

4. Provide temporary financial assistance

**History**
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*

##### **16 Del. Admin. Code § 6000-6007** Reserved {#sec-6000-6007 omnilex-key=us-de-regs-official--title-16--6000-6007}

**History**
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*

##### **16 Del. Admin. Code § 6000-6008** Department of Services for Children, Youth and Their Families - Policy and Procedures for EAS {#sec-6000-6008 omnilex-key=us-de-regs-official--title-16--6000-6008}

6008.1 Purpose

45CFR, Subsection 233.120 authorizes emergency assistance to needy families with children. The statute enables states to receive matching funds for state authorized emergency assistance services. A state is eligible for reimbursement if the services provided are used to prevent a potential family disruption.

The State Plan for Title IV-A, Emergency Assistance, of the Social Security Act details the agreement between the Delaware Department of Health and Social Services and the U.S. Department of Health and Human Services for determining service eligibility.

6008.2 Policy

A. It is the policy of the DSCYF that the protection and safety of a child are always its first priorities. Services provided are child centered and family focused.

B. The caseworker/DSCYF staff will complete and submit an application for Emergency Assistance to enable the Department to recover federal reimbursement for services which are provided to eligible cases to prevent out-of-home placement, to provide out-of-home care or to reunify the family.

C. An Emergency Assistance application must be completed for each child within a family which meets the emergency criteria (see Definitions).

D. Services will be provided to the child/family regardless of family Emergency Assistance eligibility.

6008.3 Definitions

A. Authorization: when a worker is satisfied that a child has met the eligibility criteria for Emergency Assistance services.

B. Child: a person who has not yet reached the age of 18. (1 Del.C., Subsection 302)

C. Date of application: date of the Emergency Assistance application; initiates a thirty (30) day clock to authorize services.

D. Disruption: risk of removal or removal from family.

E. Effective date: date of service delivery initiation which starts the twelve month eligibility period; may include services delivered up to 30 days prior to application and services delivered on or subsequent to the date of application.

F. Emergency: when a child is at risk of removal, there is a need for immediate removal, reunification with the family is pending and there is a potential for disruption or disruption has occurred.

G. Emergency Assistance: federally reimbursable services provided to meet situations requiring immediate action or emergencies where the child may be removed from the family.

H. Family: a child and a parent or custodial adult.

I. Out-of-home care: when a child is not living with a legal parent.

J. Specified Relative: per the Social Security Act, parents (biological, adoptive, and step) and those persons denoted by grand, great, great-great; sibling, aunt, uncle, niece, nephew, first cousin and child of the first cousin; the relationship continues despite death or divorce.

K. Resources: cash on hand (in pocket, checking or savings) to alleviate the emergency conditions. A family is without resources where family income is less than $73,000. Worker judgement will be used based on file documents, family provided information, and worker knowledge of the family. The income level established is two times the State median income.

6008.4 Procedures

A. The Emergency Assistance application may be triggered by a family emergency in one of the three following case events occurring in DSCYF programs:

1. completion of a risk assessment and the case remains open for program services (if no additional services are necessary and the case is closed, no EA application is necessary).

2. out-of-home placement (e.g., emergency shelter, foster care, detention, hospitalization) of a child.

3. the potential or actual disruption of a family reunification (occurs when a child is returned home from out-of-home care).

B. A family/child will be eligible for Emergency Assistance when they meet the following eligibility requirements:

1. within the six months prior to the application, a child has spent a minimum of one night residing with a specified relative.

2. the need for emergency assistance was not created because an adult family member refused to accept employment or training for employment.

3. the child is without resources immediately accessible to meet his/her needs to alleviate the emergency condition.

C. FACTS Emergency Assistance (EA) Application Screen Procedures are used for a case already entered into FACTS. At page 23-1 in the FACTS User's Manual, the EA application procedures are described. Once the application screens are completed, there is no further EA action necessary for the person making this application.

**History**
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*

##### **16 Del. Admin. Code § 6000-6100** Providing Transitional Resources To Relative Caregivers {#sec-6000-6100 omnilex-key=us-de-regs-official--title-16--6000-6100}

31 Del.C. §356, SSA §404

This policy applies when a non-parent relative needs assistance to provide for the needs of a child who has moved into the home within the last 180 days. Payments made by the Program are disregarded for the Emergency Assistance Program, Division of Social Services cash assistance programs, the Food Supplement Program, and the Child Care Subsidy Program.

Refer clients to the Division of State Service Centers to receive services.

**History**
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*

##### **16 Del. Admin. Code § 6000-6101** Reserved {#sec-6000-6101 omnilex-key=us-de-regs-official--title-16--6000-6101}

**History**
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*

##### **16 Del. Admin. Code § 6000-6102** Reserved {#sec-6000-6102 omnilex-key=us-de-regs-official--title-16--6000-6102}

**History**
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*

##### **16 Del. Admin. Code § 6000-6103** Determining Eligibility {#sec-6000-6103 omnilex-key=us-de-regs-official--title-16--6000-6103}

31 Del.C. §356, SSA §404

1. Applicants Must Meet Financial Criteria

Applicants must meet the following financial criteria.

A. Income.

1. The income of the household cannot exceed 200% FPL for the household size. Count only the income of the caregiver and the caregiver’s spouse. The household size is the caregiver, caregiver’s spouse and the caregiver’s children under age 18.

2. Do not count the income of the child moving into the home and any siblings (or half-siblings) who also reside in the home.

B. Resources are excluded.

2. Applicants Must Meet Technical Criteria

Applicants must meet the following technical criteria.

A. Relationship. The child is living with a relative within the 5th degree of relationship, as defined by DSSM 3004.

Exception: The parent cannot live in the home with the caregiver.

B. Age. The child is less than 18 years of age.

C. Residence. Applicants live in Delaware. Persons who currently live in Delaware and plan to stay, including the homeless, meet the residency requirement.

D. Time Limitation. The child has been living in the caregivers home less than or equal to 180 days.

E. Citizenship. The child is a citizen or a lawfully admitted alien.

F. Need. The child has need for one or more of the covered services.

3. Applicants Must Verify Eligibility Factors

The following eligibility factors must be documented.

A. Household income.

B. The identity of the caregiver(s)

C. Alien status of the child

D. Cost of needed services. Caregivers have the option of presenting estimates from a vendor for the needed services or receipts itemizing the expenditures for the needed service. See DSSM 6108 listing conditions for caregiver reimbursements.

The following eligibility factors are accepted by declaration.

A. Age. The date of birth of the child(ren).

B. Relationship. The relationship of family members

C. Delaware residency

D. Time limitation

E. Citizenship of the child

**History**
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*

##### **16 Del. Admin. Code § 6000-6104** Reserved {#sec-6000-6104 omnilex-key=us-de-regs-official--title-16--6000-6104}

**History**
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*

##### **16 Del. Admin. Code § 6000-6105** Reserved {#sec-6000-6105 omnilex-key=us-de-regs-official--title-16--6000-6105}

**History**
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*

##### **16 Del. Admin. Code § 6000-6106** Reserved {#sec-6000-6106 omnilex-key=us-de-regs-official--title-16--6000-6106}

**History**
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*

##### **16 Del. Admin. Code § 6000-6107** Reserved {#sec-6000-6107 omnilex-key=us-de-regs-official--title-16--6000-6107}

**History**
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*

##### **16 Del. Admin. Code § 6000-6108** Making Payments For Covered Services {#sec-6000-6108 omnilex-key=us-de-regs-official--title-16--6000-6108}

31 Del.C. §356, SSA §404

This policy applies to Kinship Care Transitional Resource Program recipients. Payments made by the Program are disregarded for the Emergency Assistance Program, Division of Social Services cash assistance programs, the Food Supplement Program, and the Child Care Subsidy Program.

There is no guarantee services will be provided. DHSS reserves the right to limit services based on available resources and funding.

1. DSSC May Pay the Vendors

Caregivers may elect to verify the cost of needed services by presenting estimates to Division of State Service Centers (DSSC) staff. In these instances payments are made by check payable to the vendor.

2. DSSC May Reimburse the Caregivers

The caregiver may be reimbursed when the following conditions are met:

A. The purchase(s) are made after application for the Kinship Care Transitional Resource Program

B. The purchases were approved in advance by DSSC staff

C. The caregiver provides verification of the purchase(s).

3. Benefit Amounts Are Limited

The maximum benefit is $500 per child per transition period per year. The year starts with the date benefits were provided by the Kinship Care Transitional Resource Program.

4. Covered Items/Services Are Limited

The Kinship Care Transitional Resource Program payment is made to meet the needs arising from the child's moving into the caregiver's home. Payments may be used for items and/or services such as but not limited to:

A. Clothing for the child.

B. Furniture such as beds, chairs, dressers

C. Bed linens, blankets, towels

D. School supplies such as notebooks, pencils, calculators, etc.

E. Items which directly foster child health or safety such as a car seat or infant monitor

F. Supplies

Exception: Recreational electronic equipment such as personal computers, televisions, or stereos is not covered.

**History**
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*

##### **16 Del. Admin. Code § 6000-6111** Fair Hearing Practice and Procedures {#sec-6000-6111 omnilex-key=us-de-regs-official--title-16--6000-6111}

45 CFR 205.10

Applicants and recipients have the right to request a fair hearing if they disagree with any Kinship Care Transitional Resource Program decision made by the Division of State Service Centers. See DSSM section 5000. The Division of Social Services Hearing Office will schedule and conduct the fair hearings.

**History**
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 426 (10/01/12)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*
- *5 DE Reg. 2308 (06/01/2002)*
- *16 DE Reg. 211 (08/01/12)*

#### **7000** Cash Assistance Overpayments

##### **16 Del. Admin. Code § 7000-7001** Audit and Recovery Management Services (ARMS) and the Overpayment Process {#sec-7000-7001 omnilex-key=us-de-regs-official--title-16--7000-7001}

ARMS has the responsibility for five functional areas as part of Fraud/Overpayment process:

1) Identification - Responsible for the identification of acts of welfare fraud/overpayments from information obtained through IEVS, agency referrals, citizen complaints and other sources.

2) Audit/Investigation - Responsible for the Audit/Investigation of alleged acts of welfare fraud.

3) Referral for Prosecution/Overpayments - Responsible for the preparation of Referral for Prosecution for felony indictment to the Office of the Attorney General; referral of a case directly to a court of competent jurisdiction; or, preparation of an administrative overpayment.

4) Accounting - ARMS is the fiscal agent for the Department, with full responsibility for functional activity such as: establishing repayment agreements with indebted individuals, tracking overpayments and notifying DSS when overpayments are paid in full.

5) Collection Enforcement - Enforce recovery methods of debts through a variety of collection methods.

**History**
- *13 DE Reg. 1462 (05/01/10)*
- *13 DE Reg. 1462 (05/01/10*
- *13 DE Reg. 1462 (05/01/10*
- *13 DE Reg. 1462 (05/01/10*
- *13 DE Reg. 1462 (05/01/10)*
- *13 DE Reg. 1462 (05/01/10)*
- *13 DE Reg. 1462 (05/01/10)*
- *13 DE Reg. 1462 (05/01/10)*
- *13 DE Reg. 1462 (05/01/10)*
- *13 DE Reg. 1462 (05/01/10)*

##### **16 Del. Admin. Code § 7000-7002** Determining the Amount of Overpayments {#sec-7000-7002 omnilex-key=us-de-regs-official--title-16--7000-7002}

An overpayment is a Cash Assistance payment made in excess of the amount a recipient is entitled to receive. Overpayments may be caused by client or agency error. In either situation, the recipient is expected to repay to DHSS the amount of benefits received in error. Repayment is based on the legal principle that when a person is paid benefits to which (s)he is not entitled, the payer has a right to recovery of those benefits.

All applicants for financial assistance will be informed of their responsibility to repay overpayments at application. They will be asked to sign the application which explains recipients' responsibilities to repay overpayments and outlines the methods by which overpayment debts can be recovered.

7002.1 Cash Assistance Overpayments

1) Technical Ineligibility (Non-financial reasons)

When an overpayment occurs because a recipient is technically ineligible for assistance, the overpayment equals the amount of the assistance grant paid.

For Example: Mrs. Jones receives assistance for herself and two children. Mrs. Jones goes on strike from her job and does not report this change to the Division. When the situation is discovered, the entire TANF payment is an overpayment.

If only some members of an assistance unit are technically ineligible, the amount of the overpayment is the difference between the actual grant the unit received and the grant that would have been issued to the remaining eligible unit members.

For overpayments based on technical ineligibility, the overpayment period begins the month following the month of the change. In the above example, if the parent went on strike in May and it was discovered in August, the overpayment would include TANF payments made to the unit from June until the month the grant amount correctly reflected the circumstances.

2) Financial Ineligibility

When an overpayment occurs because countable income or resources were not included in determining the assistance grant, the overpayment is the difference between the grant the unit received and the grant that would have been issued if the income had been budgeted.

A. Reported Income

1) Determine the unit's prospective eligibility at the time income began. Use all income that should have been included in the budget calculations. Income that was not counted (or counted incorrectly) due to agency error, is to have income disregards applied to determine the overpayment amount. See DSSM 4004.2, 4004.3, and 8028.

2) If the unit is determined prospectively ineligible, calculate the overpayment for each month using prospective budgeting. Include in the overpayment the month that the income began if the income received in that month exceeded the applicable Standard of Need.

3) If the unit would have remained eligible, calculate the overpayment for each month using retrospective budgeting, unless actual income recovered in a subsequent month makes the unit ineligible. In that case, budget the remaining months prospectively. This is for overpayments occurring prior to November 1, 1995.

4) Overpayments occurring after November 1, 1995 will be processed prospectively. The overpayment is to be processed prospectively regardless of whether the unit is totally ineligible for a benefit or if the unit is eligible for a partial benefit.

B. Unreported Income

1) Determine the unit's prospective eligibility at the time income began. Include all income that should be counted in the budget calculation. Do not allow income disregards on that income which was not reported. See DSSM 4004.2, 4004.3, and 8028.

2) If the unit is determined prospectively ineligible, calculate the overpayment for each month using prospective budgeting. Include in the overpayment the month the income began if the income received in that month exceeded the applicable Standard of Need.

3) If the unit would have remained eligible, calculate the overpayment for each month using retrospective budgeting, unless actual income recovered in a subsequent month makes the unit ineligible. In that case, budget the remaining months prospectively. This is for overpayments occurring prior to November 1, 1995.

4) Overpayments occurring after November 1, 1995 will be processed prospectively. The overpayment is to be processed prospectively regardless of whether the unit is totally ineligible for a benefit or if the unit is eligible for a partial benefit.

C. Calculating Overpayments Resulting From Unreported Income

1) Determine the unit's prospective eligibility at the time the income began. Include all income that was actually counted in the budget calculation and any income that was not included in the calculation, but should have been.

NOTE: If income was not counted because of agency error, allow income disregards applicable to the client's assistance. If income was unreported, do not allow any disregards. See DSSM 4004.2, 4004.3, and 8028.

2) If the unit is determined prospectively ineligible, calculate the overpayment for each month using prospective budgeting. Include in the overpayment the month that the income began if the income received in that month exceeded the applicable Standard of Need.

3) If the unit would have remained eligible, calculate the overpayment for each month using retrospective budgeting, unless actual income received in a subsequent month makes the unit ineligible. In that case, budget the remaining months prospectively. This is for overpayments occurring prior to November 1, 1995.

4) Overpayments occurring after November 1, 1995 will be processed prospectively. The overpayment is to be processed prospectively regardless of whether the unit is totally ineligible for a benefit or if the unit is eligible for a partial benefit.

To illustrate, suppose a TANF recipient begins receiving income in January, and DSS is informed of the income in May. A budget is computed to determine prospective eligibility for February, and the unit is found ineligible for February benefits. February is the first month of the overpayment period, and the overpayment amount for each month is determined using prospective budgeting. January could also be included in the overpayment period if the income actually received in January exceeded the applicable Standard of Need.

D. Offsetting Overpayments

When DSS discovers that a cash assistance client has been underpaid, the underpayment must be offset by any existing overpayment debt that was incurred in the same category of assistance. Once the offset has been made, any remaining underpayment is restored to the recipient. To calculate the offset, ARMS will determine if any prior overpayments exist and subtract the outstanding overpayment amount from the underpayment amount.

For example, Mrs. Jones has an outstanding TANF overpayment debt of $200. Later, DSS discovers that Mrs. Jones was underpaid $250 in TANF benefits. The underpayment amount ($250) is offset with the outstanding debt ($200) and a restoration of $50 is issued to Mrs. Jones by ARMS.

In these situations, the new overpayment balance must be entered in DCIS by ARMS to ensure that recoupment continues properly, if applicable.

E. Procedure For Benefit Restoration

To restore benefits, prepare a Form 106, Benefit Restoration/Underissuance Form. Form 106 should contain signatures of the worker completing the document, the Pool Supervisor, and the respective Operations Administrator. Forward Form 106 to ARMS/Accounting Section.

Do not include any current month's benefits in the restoration, as the current month's benefits can be issued by the DSS local office. Local offices, however, are not to issue any benefits for a previous month(s).

Benefit restorations, like all other overpayments, are then submitted to ARMS. ARMS researches their overpayment records for outstanding overpayments and makes any necessary adjustments to the recoupment balance as a result of the offsetting process.

The Form 106 is then post-audited by the DMS/Client Payments Section.

F. Exceptions To Repayment To DSS

For cases where TANF recipients retain child support payments assigned to the State and DCSE has established a support order, the DCSE will file a claim, obtain a debt acknowledgment, and establish a repayment agreement with the indebted recipient.

7002.2 Food Stamp Claims

Repealed

7002.3 Criteria for Establishing Inadvertent Household and Administrative Error Claims

Repealed

7002.4 Calculating Food Stamp Claims

Repealed

**History**
- *13 DE Reg. 1462 (05/01/10)*
- *13 DE Reg. 1462 (05/01/10*
- *13 DE Reg. 1462 (05/01/10*
- *13 DE Reg. 1462 (05/01/10*
- *13 DE Reg. 1462 (05/01/10)*
- *13 DE Reg. 1462 (05/01/10)*
- *13 DE Reg. 1462 (05/01/10)*
- *13 DE Reg. 1462 (05/01/10)*
- *13 DE Reg. 1462 (05/01/10)*
- *13 DE Reg. 1462 (05/01/10)*

##### **16 Del. Admin. Code § 7000-7003** Processing Overpayments {#sec-7000-7003 omnilex-key=us-de-regs-official--title-16--7000-7003}

7003.1 Routing

Information regarding each claim/overpayment is to be transmitted from the DSS local office network to the ARMS Regional Area Office Supervisor as follows:

Suspected Intentional Violations

Suspected intentional violations meeting criteria for DOJ referral specified below are to be transmitted using a "Referral for Prosecution and Overpayment Form." If the criteria is met, ARMS will prepare the overpayment for forwarding to DOJ for legal action.

Overpayments should be referred to DOJ for prosecution when the following conditions exist:

After the overpayment is prepared, it is forwarded to the DOJ. When the overpayment has been processed through the Court system, it is returned by the Attorney General to ARMS. Here the results are logged and the Criminal Justice report is forwarded to DSS. If the client has been found guilty of an intentional Program violation, initiate action to disqualify the individual from the Program and notify ARMS of the disqualification so ARMS can complete the FCS-524 form. ARMS will initiate collection action by mailing a Repayment of Debt agreement and initiating recoupment or allotment reduction when appropriate.

When a DSS case has been referred to the DOJ for prosecution, the casefile is to be intact even though the contents may be more than three years old and otherwise subject to purging, per DSSM 1005.

To alert DSS that a record has been sent to the DOJ and should not be purged, ARMS will forward a copy of the Criminal Justice Report for insertion in the casefile. The presence of these forms will indicate that the case has been referred for prosecution and is to remain intact regardless of case activity status.

Suspected Intentional Violations Under $1,000 and all Non-fraud Violations

Recoupment is automatically initiated when overpayment information is entered into DCIS. The system automatically calculates all case changes that result from recoupment and sends a notice to the recipient informing him/her of the changes. The notice is to be mailed at least ten 10) days before the changes will occur. As payments are withheld through recoupment, the system also tracks the overpayment balance. When the balance is zero (0), the system discontinues recoupment. When a regular monthly grant is not issued, the DSS worker is to deduct the monthly recoupment amount and notify ARMS of the amount deducted from the grant. If the recoupment balance is incorrect or a case has not been placed on recoupment, ARMS will enter the correct balance into DCIS.

CASH ASSISTANCE OVERPAYMENTS

1. Calculate the overpayment as per DSSM 7002.1.

2. Complete Part A of form 920. Then send the overpayment package with form 920 to the Operations Administrator via the supervisor for approval and signature.

3. Open Cash Assistance Cases

a) Date the notice and copy it. Mail one overpayment package to the client, send one overpayment package to ARMS with form 920, and file one overpayment package on the record.

b) Prior to taking further action, wait thirteen days from the date the notice is mailed to the client to see if the client requests a fair hearing.

c) If the client doesn't request a fair hearing, initiate recoupment as appropriate using reason code 757 in Section 2.

* Check with ARMS to determine the balance amount if a prior overpayment is being recouped. Once the amount is determined, enter the amount in Section 12.

4. Closed Cash Assistance Cases

Date the notice and copy it. Mail one overpayment package to the client. Send one overpayment package (with Form 920) to ARMS with a note indicating that the case is closed and that the client was noticed. File one overpayment package in the case record.

**History**
- *13 DE Reg. 1462 (05/01/10)*
- *13 DE Reg. 1462 (05/01/10*
- *13 DE Reg. 1462 (05/01/10*
- *13 DE Reg. 1462 (05/01/10*
- *13 DE Reg. 1462 (05/01/10)*
- *13 DE Reg. 1462 (05/01/10)*
- *13 DE Reg. 1462 (05/01/10)*
- *13 DE Reg. 1462 (05/01/10)*
- *13 DE Reg. 1462 (05/01/10)*
- *13 DE Reg. 1462 (05/01/10)*

##### **16 Del. Admin. Code § 7000-7004** Collections {#sec-7000-7004 omnilex-key=us-de-regs-official--title-16--7000-7004}

7004.1 Methods of Collecting Cash Assistance Overpayments

Recoupment - Recoupment is the withholding of a portion of an assistance payment to an individual who is eligible for and in receipt of assistance under TANF or GA programs in order to recover an overpayment.

The amount recouped from an assistance grant from an agency caused overpayment will be 7% of the maximum payment standard for the family size or $15.00, whichever is greater. The amount recouped from an assistance grant from a client caused overpayment will be 10% of the maximum payment standard for the family size or $15.00, whichever is greater.

FAMILY SIZE

TANF RECOUPMENT RATE

GA RECOUPMENT RATE

CLIENT CAUSED

AGENCY CAUSED

CLIENT CAUSED

AGENCY CAUSED

1

$20

$15

$15

$15

2

$27

$19

$17

$15

3

$34

$24

$22

$16

4

$41

$28

$26

$18

5

$48

$33

$32

$23

6

$54

$38

$37

$26

7

$61

$43

$42

$29

Over seven (7) in TANF:

Add $5.00 per person to the amount collected for a family of seven (7) for agency caused overpayments.

Add $7.00 per person to the amount collected for a family of seven (7) for client caused overpayments.

Over seven (7) in GA:

Add $3.00 per person to the amount collected for a family of seven (7) for agency caused overpayments.

Add $4.50 per person to the amount collected for a family of seven (7) for client caused overpayments.

All current cash assistance recipients who have outstanding overpayment debts are subject to recoupment if the overpayment occurred after 07/10/80, and was caused by the recipient. Agency caused overpayments are automatically recouped if they occurred after 10/01/81. Client caused overpayments that occurred before 07/10/80 and agency caused overpayments that occurred before 10/01/81 can be recouped only if the recipient agrees to this type of collection.

Only TANF overpayments can be recouped from a TANF grant, and only GA overpayments can be recouped from a GA grant. Food benefits, Medicaid, Child Support, Day Care, or other debts cannot be repaid by recouping funds from a Cash Assistance grant.

PLEASE NOTE: When completing an overpayment, the gross amount of the grant should be used.

For example, Ms. Jones received a TANF check for $235 but was recouped $15 for a previous overpayment. In calculating the new overpayment, $250 would be used for the actual grant that was issued.

Restitution - Restitution is the repayment of assistance to which a recipient was not entitled. Individuals who are not subject to recoupment must make repayment directly to the Accounting Section of ARMS.

Reimbursement - Reimbursement is the repayment by the recipient of assistance benefits for which the recipient was eligible but is required to repay. An example is the repayment of assistance received during the six-month period in which a second real estate holding is excluded as a resource in order to allow the TANF recipient an opportunity to sell the property.

Notification to Recipients of Overpayments - When a cash assistance overpayment has been processed and collection will be initiated either through recoupment, restitution or reimbursement, the indebted individual must be notified of the overpayment debt. The DSS worker is to send the notice of TANF or GA overpayment to the individual, stating the amount of the overpayment, the circumstances that caused it, the amount that will be withheld from the assistance grant if they are active, and that they will be contacted at a later date regarding repayment of the overpayment debt. The notice must also inform the individual of his/her right to request a hearing on the overpayment issue. If the overpayment is not subject to recoupment, the amount of the overpayment should still be entered into DCIS.

7004.2 Case Changes

When a case that is subject to recoupment is closed and there is an outstanding overpayment balance, it is the responsibility of ARMS to contact the individual, establish a repayment agreement, and collect payments on the obligation. ARMS is notified of such closing via a report from DCIS.

If a prior recipient reapplies for Cash Assistance and has an outstanding overpayment balance, recoupment must be initiated when the application is approved. To ensure that the overpayment is recouped correctly, the intake worker is to contact the Accounting Section of ARMS for the current overpayment balance and determine if proper notification was sent to the client previously. If proper notice was not sent previously, the DSS worker must recalculate the overpayment and notify the prior recipient of the overpayment. The overpayment balance should be data entered into the DCIS system by DSS. Any corrections to recoupment balances will be corrected by ARMS.

7004.3 Collection and Management of Food Stamp Claims

Repealed

7004.4 Methods of Collection – Chart

Repealed

**History**
- *13 DE Reg. 1462 (05/01/10)*
- *13 DE Reg. 1462 (05/01/10*
- *13 DE Reg. 1462 (05/01/10*
- *13 DE Reg. 1462 (05/01/10*
- *13 DE Reg. 1462 (05/01/10)*
- *13 DE Reg. 1462 (05/01/10)*
- *13 DE Reg. 1462 (05/01/10)*
- *13 DE Reg. 1462 (05/01/10)*
- *13 DE Reg. 1462 (05/01/10)*
- *13 DE Reg. 1462 (05/01/10)*

##### **16 Del. Admin. Code § 7000-7005** Changes in Unit/Household Composition {#sec-7000-7005 omnilex-key=us-de-regs-official--title-16--7000-7005}

ARMS can recover Cash Assistance overpayments from any assistance unit of which a member of the overpaid assistance unit has subsequently become a member.

**History**
- *13 DE Reg. 1462 (05/01/10)*
- *13 DE Reg. 1462 (05/01/10*
- *13 DE Reg. 1462 (05/01/10*
- *13 DE Reg. 1462 (05/01/10*
- *13 DE Reg. 1462 (05/01/10)*
- *13 DE Reg. 1462 (05/01/10)*
- *13 DE Reg. 1462 (05/01/10)*
- *13 DE Reg. 1462 (05/01/10)*
- *13 DE Reg. 1462 (05/01/10)*
- *13 DE Reg. 1462 (05/01/10)*

#### **8000** Refugee Resettlement Program

##### **16 Del. Admin. Code § 8000** Basis and Purpose of the Program {#sec-8000 omnilex-key=us-de-regs-official--title-16--8000}

Through a grant provided under Title IV of the Immigration and Nationality Act, DSS administers a program to provide for the effective resettlement of refugees and to assist them to achieve economic self‑sufficiency as quickly as possible. The provision of English language training and employment services are national priorities in accomplishing the purpose of this program.

**History**
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 1366 (06/01/11)*
- *9 DE Reg. 1237 (02/01/06)*

##### **16 Del. Admin. Code § 8000-8005** Definitions {#sec-8000-8005 omnilex-key=us-de-regs-official--title-16--8000-8005}

The following definitions are applicable for purposes of this part:

"Cuban/Haitian Entrant" Any individual granted parole status as a Cuban/Haitian Entrant (Status Pending) or granted any other special status subsequently established under the immigration laws for nationals of Cuba or Haiti, regardless of the status of the individual at the time assistance or services are provided.

Individuals having a final, non‑ appealable, and legally enforceable order of deportation or exclusion entered against them cannot be considered for services under this program.

"Filing unit" means an individual or individuals whose needs are taken into account in determining eligibility for, and the amount of, assistance for which Federal reimbursement is claimed.

"ORR" means the Federal Office of Refugee Resettlement.

"Payment levels" In determining the amount of RCA payment to an eligible refugee who meets the need standards in DSSM 8024 , and applying the consideration of income and resources defined immediately above, DSS must pay according to the benefit calculation in DSSM 8032 .

"Refugee" means an individual who is outside any country of such person's nationality and who is unable or unwilling to return to, and is unable or unwilling to avail him/herself of the protection of, that country because of persecution or a well‑ founded fear of persecution on account of race, religion, nationality, membership in a particular social group, or political opinion.

"Refugee cash assistance (RCA)" means cash assistance provided to refugees who are ineligible for TANF or SSI and who have resided in the United States for less than a period of eight months from their initial entry to the U.S.

"Refugee medical assistance (RMA)" means medical assistance provided to refugees who are ineligible for Medicaid benefits and who have resided in the United States for less than a period of eight months from their initial entry to the U.S.

"Sponsor" means an individual, church, civic organization or other group or organization which has agreed to help in the reception and initial placement of refugees in the United States.

"Support Services" means services provided by, or purchased by, a state, which are designated to meet resettlement needs of refugees, for which Federal funding is available.

"Voluntary Resettlement Agency (VOLAG)" means one of the national resettlement agencies (or its local affiliate or sub‑ contractor) that has entered into a grant, contract or cooperative agreement with the U.S. Department of State to provide for the reception and initial placement of refugees in the U.S.

**History**
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 1366 (06/01/11)*
- *9 DE Reg. 1237 (02/01/06)*

##### **16 Del. Admin. Code § 8000-8006** RCA and SSI Recipients {#sec-8000-8006 omnilex-key=us-de-regs-official--title-16--8000-8006}

A Supplemental Security Income (SSI) recipient cannot receive RCA payments for himself while receiving SSI, but may be a payee for an RCA grant for others. The SSI recipient is not regarded as a member of the family when determining a family's RCA financial eligibility or benefit amount, and none of the SSI recipient's income or resources is counted as income to the family.

An SSI recipient may elect to receive RCA rather than SSI payments, if otherwise eligible. In such instances, the RCA payment may not be authorized until it has been verified that the SSI payment has ceased.

**History**
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 1366 (06/01/11)*
- *9 DE Reg. 1237 (02/01/06)*

##### **16 Del. Admin. Code § 8000-8007** Unaccompanied Minor Case Processing - Foster Care {#sec-8000-8007 omnilex-key=us-de-regs-official--title-16--8000-8007}

The Title IV-E Eligibility worker within the Department of Services to Children, Youth and Their Families will determine if the child is eligible for Title IV-E funds. A child could be in foster care for a period of time before the IV-E eligibility determination is made. The child receives State Only Foster Care payments until Title IV-E eligibility is established. The Title IV-E Eligibility Worker will notify the DSS Social Worker when the Title IV-E determination is completed and the starting date for Title IV-E matching funds. The DSS Social Worker will contact the Title IV-E Eligibility Worker (phone number: 633-2517) at each application and redetermination to determine the foster care funding source. If the funding changes from State Only Foster Care to Title IV-E Foster Care, close the child's public assistance grant.

8007.1 RCA and Title IV-E (Foster Care)

If a child is living with a minor parent and the minor parent receives Title IV-E Foster Care, the child cannot be included in an RCA grant.

Instead, the Department of Services to Children, Youth and Their Families will include the child in the minor parent's Title IV-E foster child payment as required by the Omnibus Budget Reconciliation Act (OBRA) of 1987.

8007.2 RCA and State Only Foster Care

If a child is living with a minor parent and the minor parent receives State Only Foster Care payments, the child may receive public assistance. The minor parent cannot be included in the public assistance program.

The minor parent may be an RCA payee if she cares for the child and is capable of handling funds. Contact the minor parent's Child Protective Services worker for this determination.

If someone other than the minor parent cares for the child or if the minor parent is not capable of handling funds, an adult in the household may be payee. If the adult meets the definition of a "specified relative" (Social Services Manual Section 3004 ), that adult may receive TANF for the child. If the adult does not meet the definition of a "specified relative," that adult may receive GA for the child.

The minor parent is not included in the RCA grant and the State Only Foster Care payment is not considered income to the child.

**History**
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 1366 (06/01/11)*
- *9 DE Reg. 1237 (02/01/06)*

##### **16 Del. Admin. Code § 8000-8008** Eligibility Criteria {#sec-8000-8008 omnilex-key=us-de-regs-official--title-16--8000-8008}

**History**
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 1366 (06/01/11)*
- *9 DE Reg. 1237 (02/01/06)*

##### **16 Del. Admin. Code § 8000-8009** Registration for Employment {#sec-8000-8009 omnilex-key=us-de-regs-official--title-16--8000-8009}

Refugees meeting the State's normal TANF requirements (i.e., persons who would qualify for TANF regardless of their refugee status) must register for the Employment and Training Program as appropriate (see DSSM 3006 ).

All refugees receiving cash assistance (TANF or RCA) will be referred to the Refugee Social Services Contractor. The contractor will provide case management, English language training, employment Services and other necessary social services to all refugee clients. Any employable refugee, in the RCA program, unwilling to cooperate in this effort will be sanctioned per rules in DSSM 8010.4 . Staff are to send a list of refugees in the United States less than 5 years to the Refugee State Office.

Inability to communicate in English does not exempt an employable refugee from work registration.

Full-time attendance at an institution of higher education does not constitute an exemption from work registration.

**History**
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 1366 (06/01/11)*
- *9 DE Reg. 1237 (02/01/06)*

##### **16 Del. Admin. Code § 8000-8010** Employment and Training Participation {#sec-8000-8010 omnilex-key=us-de-regs-official--title-16--8000-8010}

The Employment and Training Program is designed to assist clients in preparing for and securing employment. Services are offered by DSS to Refugee TANF and RCA clients through contracts with community agencies to provide employment and training activities.

Refugees will be served via the Refugee Social Services contracts.

The following clients will be exempted from E & T registration:

1. All persons under age 16.

2. Children who are:

16 or 17, and

attending an elementary, secondary, or vocational or technical school fulltime.

3. Parents or other caretaker relatives of children under age three (3) who are personally providing full-time care for the child with only very brief and infrequent absences from the child. Examples of such absences include, but are not limited to, working part time, attending school part time, and participating in community projects. Children under age three (3) may be absent from the home to attend pre‑ school or Head Start or be absent for any other allowable reason, and the caretaker remains exempt from participation; ‑ Note: A full-time college student is not exempt from Employment and Training participation even if the student attends school less than 29 hours per week. Only one parent or other relative in a case may be exempt.

4. A person who is ill or incapacitated as determined by medical evidence and the illness and/or injury or incapacity is serious enough to prevent participation in Employment and Training activities. Ill or incapacitated persons must be referred to the Division of Vocational Rehabilitation (VR), if the estimated duration of the incapacity stated on Form 184 is twelve (12) months or more, or indefinite. Refer the person(s) using Form 220, unless they have been referred from another source such as a physician, the Social Security Administration, or self‑ referral, and this fact is documented in the record. If the estimated duration of the incapacity stated on Form 184 is less than twelve (12) months, the person(s) should not be referred to VR. (NOTE: Workers will need to review the status of a person's incapacity at each redetermination and by the end of the period of stated incapacity.

Set controls to assure that a review is made not later than the stated period of incapacity. If the stated period of incapacity is "indefinite," set the control at the end of six months. When incapacity ends, the client must be referred to the appropriate Refugee Social Services contractor for participation).

5. A Person who is sixty-five (65) years of age or older.

6. Persons whose presence in the home is required because of the illness or incapacity of another member of the household. (This exemption requires a physician's verification.)

7. Persons working 30 hours per week in unsubsidized employment and earning the federal minimum wage in work expected to last 30 days.

8. Pregnant women beginning in the third (3rd) month of pregnancy.

Note: The RCA worker will register all clients for Employment and Training at the time of application for RCA benefits. Registration is accomplished through DCIS.

8010.1 Employment and Training Participation

The RCA worker will refer all mandatory and voluntary participants by correctly coding the DCIS document. Clients who must participate will be informed of the penalties for failure to participate (DSSM 8010.4 ).

8010.2 Employment and Training - Case Processing Instructions

1. All applicants and recipients are registered when they are referred to Employment and Training.

2. At the application interview, mandatory Employment and Training participation and penalties for failing to participate are explained to the client. Participant status (mandatory/exempt) of all unit members as specified in DSSM 8010 are determined.

3. Upon approval of the RCA application, mandatory and voluntary participants are referred to the Employment & Training Program through DCIS for each participant. The Social Service Contractor is responsible for contacting the participant to begin the participation process. Participation must be with the Refugee Social Services contractor. Further referrals will be made by this contractor.

4. Persons who are exempt from participation because of an incapacity expected to last 12 or more months are referred to the Division of Vocational Rehabilitation. Form 220 is used to refer. Form distribution is included on the Form 220.

5. Exempt status of recipients is monitored at and between redetermination periods. At the redetermination interview, mandatory Employment and Training participation and penalties for failing to participate are explained to the client. Participant status (mandatory/exempt) of all unit members as specified in DSSM 8010 are determined.

Eligibility staff monitor exempt status between redeterminations in the following manner:

6. The Social Services Contractor will inform the DSS worker participant is placed in employment. The DSS worker will then reduce or terminate the RCA grant and notify the Social Services Contractor of the reduction.

7. Never refer a refugee to workfare.

8010.3 Employment and Training Verification Requirements

1. Referral for Employment & Training participation is verified through DCIS and documented in Case Remarks.

2. Participation exemptions are verified as follows:

a. Age and employment are verified for RCA eligibility. No further verification is required.

b. School attendance is verified for dependent children, ages 16 or 17, by Form 168.

c. Illness or incapacity is verified by Form 184.

d. Persons needed in the home to care for another family member who is ill or incapacitated are verified by Form 184.

e. Pregnancy is verified by Form 184.

f. Absences by a caretaker of children under three (3) is verified by documenting the length and nature of the absence.

8010.4 Employment and Training Sanctions

When an RCA recipient who is a mandatory participant in the Employment and Training Program has been found to have failed or refused without good cause to participate in the program, the individual will be sanctioned.

Failure to participate without good cause is determined by the Social Services Contractor. Good cause for failure to participate in Employment and Training or refusal to accept employment exists when:

Illness of another household member requiring the presence of the participant; or

Court required appearance; or

Household emergency; or

Unavailability of transportation; or

Inclement weather which prevented travel.

The sanctioned individual's needs will not be taken into account in determining the family's need for assistance. The income, with disregards, and resources of the sanctioned individual will be considered available to the assistance unit.

When the sanctioned individual is the only dependent child in the home, the child is considered a dependent child for the purpose of determining eligibility for the family. The parent/caretaker remains technically eligible for assistance.

For the first occurrence of failure or refusal to participate without good cause, the individual will be sanctioned until the failure to comply ceases. For the second occurrence of failure or refusal to participate without good cause, the individual will be sanctioned for three (3) payment months or until the failure to comply ceases, whichever is longer. For the third and subsequent occurrences of failure or refusal to participate without good cause, the individual will be sanctioned for six (6) payment months or until the failure to comply ceases, whichever is longer.

The Employment Contractor must send a reminder at the end of three (3) months to any individual who has been sanctioned. The reminder will state that the individual has the option:

8010.5 Employment and Training Case Processing Instructions - Sanction

1. The Employment Contractor will send a written statement to any mandatory Employment and Training participant of the intent to initiate a sanction for failing to participate in the Employment and Training Program without good cause. The client will be given ten (10) days to respond to the provider. If there is a response, the provider will attempt to resolve the non‑ participation issue.

2. If there is no response to the written statement or the issue cannot be resolved by the end of the ten (10) day period, the contractor will alert the DSS worker who will sanction the individual by removing him/her from the assistance unit as specified in DSSM 8010.4 .

3. The DSS worker will notify the Employment Contractor when the sanction is imposed.

The client is notified of the reduction or termination of RCA benefits via the client notices. The notices clearly indicate that benefits are reduced as a result of Employment and Training non-cooperation. The notice also includes the duration of the Employment and Training sanction period.

4. The DSS worker must send a reminder at the end of three (3) months to any individual who has been sanctioned.

8010.6 Employment and Training Ending a Sanction

Individuals who have been Employment and Training sanctioned must reapply at the end of the sanction period and participate in Employment and Training before they can be added to the assistance unit.

When the individual successfully participates in Employment and Training, the sanction will be considered to have ended as of the day she agreed to participate or the sanction period ends whichever is later.

The Social Services provider will have thirty (30) days to determine whether or not the individual is participating.

EXAMPLE: Ms. X began her second sanction on August 1. Ms. X reapplies for RCA on November 1. She brings all necessary verifications to the November 1 interview and she states she is willing to participate in Employment and Training. On November 18, the Contractor notifies the RCA worker that Ms. X is added to the RCA grant effective November1.

**History**
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 1366 (06/01/11)*
- *9 DE Reg. 1237 (02/01/06)*

##### **16 Del. Admin. Code § 8000-8011** English Language Training {#sec-8000-8011 omnilex-key=us-de-regs-official--title-16--8000-8011}

All refugee applicants should be informed of the availability of English as a Second Language (ESL) classes in their locale. Such information, if not readily available, can be obtained through the State Office.

**History**
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 1366 (06/01/11)*
- *9 DE Reg. 1237 (02/01/06)*

##### **16 Del. Admin. Code § 8000-8012** Verification with Resettlement Agencies or Sponsors {#sec-8000-8012 omnilex-key=us-de-regs-official--title-16--8000-8012}

As part of the regular process of determining (or redetermining) a refugee's eligibility for cash or medical assistance, DSS will contact the refugee's sponsor or resettlement agency and inquire as to:

a) What assistance the sponsor or resettlement agency is providing to the refugee, and

b) Whether the refugee has refused an offer of employment or has voluntarily quit a job without good cause.

This contact will also serve to notify the sponsor or resettlement agency that this refugee has applied for assistance from DSS.

**History**
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 1366 (06/01/11)*
- *9 DE Reg. 1237 (02/01/06)*

##### **16 Del. Admin. Code § 8000-8013** Hearings {#sec-8000-8013 omnilex-key=us-de-regs-official--title-16--8000-8013}

Applicants for, and recipients of, assistance and services under the Immigration and Nationality Act must be provided with an opportunity for a hearing to contest adverse determinations using hearing procedures set forth in DSSM 5000 .

If the issue is the date of entry into the United States of an applicant for, or recipient of assistance of services, DSS must provide for prompt resolution of the issue by inspection of the individual's documentation issued by the Immigration and Naturalization Service or by information obtained from INS rather than by hearing.

**History**
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 1366 (06/01/11)*
- *9 DE Reg. 1237 (02/01/06)*

##### **16 Del. Admin. Code § 8000-8014** Residency Requirements {#sec-8000-8014 omnilex-key=us-de-regs-official--title-16--8000-8014}

Applicants must reside in Delaware to be eligible for benefits. Persons including the homeless (those with no fixed address or not living in a permanent dwelling) who currently live in Delaware and plan to stay, regardless of the length of time they have been here, meet the residency requirement. Verification of residence is required at the time of application, at each subsequent redetermination, and any time an address change is reported.

Persons who reside in Delaware but because of local mailing practices have an out‑ of‑ state address are considered residents.

Examples of acceptable verification of residence are a landlord statement, a lease, a utility bill, or a collateral statement.

Do not impose requirements as to duration of residence as a condition of participation in the Refugee Resettlement Program for the provision of assistance of services.

8014.1 Assistance From Another State

Before an application for public assistance can be approved, DSS must verify that an applicant who moved to Delaware within three (3) months of the application filing date is not a recipient of assistance in the state where he/she previously resided. The eligibility worker will contact the public assistance agency in that state to verify the client's status with the agency. The client's written notice that benefits have ended is also acceptable verification.

8014.2 Mailing Address

Public assistance checks must be mailed to the residence of the recipient, protective, or voluntary payee unless the recipient:

OR

OR

8014.3 Temporary Visits Out of State

Recipients do not lose their residence status because of a temporary visit out of state provided that the visit does not exceed thirty (30) days and the recipients:

1. Intend to return to the State, and

2. Continue to maintain a home in the State.

The assistance case of a recipient who leaves the State with the intent to establish residence in another state must be closed. The recipient may receive one grant payment after leaving the State if he/she is ineligible in the new state until residency is established. No further payments can be made to a client living out of state without the written approval of the DSS Director. To obtain approval, a memo listing the reasons that the grant should continue is sent to the Director.

8014.4 Temporary Absence of a Child

A child who is temporarily absent from the home to receive medical care, or to attend school elsewhere because of special educational needs, such as enrollment in the Job Corps or Sterck School For the Deaf, may receive assistance if the following conditions exist:

1. The caretaker with whom the child is living continues to have responsibility for the child's care, and

2. The caretaker continues to maintain a home for the child; and

3. The caretaker plans for the child to return to the home at the end of the absence.

The nature and anticipated length of the absence is documented in the case record.

Children absent from the home for any other reasons longer than one hundred twenty (120) days may not continue to receive assistance.

Note: A child who is absent from the home as the result of a court action is not considered temporarily absent. In such cases the assistance for the child is terminated.

8014.5 Absence of an Adult to Receive Medical Care

An adult who is temporarily absent from the home to receive medical care can receive cash assistance for a period not to exceed 90 days provided that:

1. The adult continues to maintain a home and be responsible for the children for whom assistance is received; and

2. The adult has arranged for a responsible adult to care for any children during the absence; and

3. The adult plans to return to the home at the end of the absence; and

4. The adult continues to meet all other technical and financial eligibility requirements of the category of assistance that he/she receives.

The nature of the adult’s health problem and the anticipated length of the absence must be verified by a physician. If the absence continues for more than 90 days, the assistance case must be closed. The adult caring for the children in the assistance unit at the time of the closing may apply for assistance for the children if they are still in need.

8014.6 Other Absences of an Adult

In active cases, an adult who is temporarily absent from the home for reasons other than to receive medical care (e.g., to handle a family emergency or seek employment) may continue to receive assistance for a period not to exceed thirty (30) days if the conditions listed in DSSM 3023.4 are met.

The nature and anticipated length of the absence must be documented in the case record. If the absence continues for more than thirty (30) days, the assistance case must be closed. The adult caring for the children in the assistance unit at the time of the closing may apply for assistance for the children if they are still in need.

8014.7 Grants for Institutionalized Clients

No grant payment may be authorized or continued for an institutionalized individual. Examples of institutions include veterans’ institutions, state mental institutions, hospitals for tuberculosis and prisons.

**History**
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 1366 (06/01/11)*
- *9 DE Reg. 1237 (02/01/06)*

##### **16 Del. Admin. Code § 8000-8015** Safeguarding and Sharing of Information {#sec-8000-8015 omnilex-key=us-de-regs-official--title-16--8000-8015}

Except for purposes directly connected with, and necessary to, the administration of the Program, do not disclose information about, or obtained from, an individual and in possession of any agency providing assistance or services to such individual, in a form identifiable with the individual without the individual's consent (or, if the individual is a minor, the consent of his/her parent or guardian).

The provision by DSS to a voluntary resettlement agency as defined in DSSM 8012 , of information as to whether an individual has applied for or is receiving cash assistance and the individual's address and telephone number is to be considered undertaken for a purpose directly connected with, and necessary to, the administration of the Program during the first 24 months after such individual's entry into the United States.

**History**
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 1366 (06/01/11)*
- *9 DE Reg. 1237 (02/01/06)*

##### **16 Del. Admin. Code § 8000-8016** Documentation of Refugee Status {#sec-8000-8016 omnilex-key=us-de-regs-official--title-16--8000-8016}

Require from applicants for assistance proof, in the form of documentation issued by INS, that their status is one of the following:

1) Paroled as a refugee or asylee under Section 212(d)(5) of the Immigration and Nationality Act;

2) Admitted as a conditional entrant under Section 203(a)(7) of the Act;

3) Admitted as a refugee under Section 207 of the Act;

4) Granted asylum under Section 208 of the Act;

5) Admitted as a Vietnamese Amerasian or family member under the Amerasian Homecoming Act;

6) Admitted with an immigration status that entitled the individual to refugee assistance prior to enactment of the Refugee Act of 1980; or

7) Admitted for permanent residence, provided the individual previously held one of the statuses identified above.

AN APPLICANT FOR ASYLUM IS NOT ELIGIBLE FOR ASSISTANCE UNDER THIS ACT.

A non-refugee child can receive Refugee benefits if his/her filing unit contains one or both of his refugee parents.

A non-refugee child cannot receive Refugee benefits if one parent in the filing unit is a non-refugee.

**History**
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 1366 (06/01/11)*
- *9 DE Reg. 1237 (02/01/06)*

##### **16 Del. Admin. Code § 8000-8017** Documentation of Cuban/Haitian Status {#sec-8000-8017 omnilex-key=us-de-regs-official--title-16--8000-8017}

1) Any national of Cuba or Haiti granted parole status as a Cuban / Haitian Entrant (Status Pending) or granted any other special status.

2) Any other national of Cuba or Haiti for whom a final, nonappealable, and legally enforceable order of deportation or exclusion has not been entered.

AND WAS

(a) paroled into the U.S. and has not acquired any other status under INA, OR

(b) is the subject of exclusion or deportation proceedings under INA, OR

(c) has an application for asylum pending with INS.

**History**
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 1366 (06/01/11)*
- *9 DE Reg. 1237 (02/01/06)*

##### **16 Del. Admin. Code § 8000-8018** Refugee Support Services {#sec-8000-8018 omnilex-key=us-de-regs-official--title-16--8000-8018}

The following support (social) services available to citizens are also available to refugees in Delaware:

Services offered under Social Services Block Grant

For adults: Day Care

Homemaker Services

Services for the Visually Impaired

Residential and Foster Care

Meals for Homebound Adults Respite Care

For children: Day Care

Counseling

Shelter Services

Substitute Care

Diagnosis and Evaluation

Permanent Placement Services

Protective Services

Adolescent Services

General Services: Information and Referral

Community Resource and Assistance Services

Clients desiring child day care services may apply directly with the appropriate county day care unit.

**History**
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 1366 (06/01/11)*
- *9 DE Reg. 1237 (02/01/06)*

##### **16 Del. Admin. Code § 8000-8019** Effect of Participation in a Strike {#sec-8000-8019 omnilex-key=us-de-regs-official--title-16--8000-8019}

Any individual who participates in a strike is not eligible for cash assistance. If the individual is also the natural or adoptive parent with whom an eligible child is living, the entire family is ineligible for assistance. When participation in a strike begins after the receipt of an assistance grant, the grant for that month must be recovered as an overpayment.

A strike is defined as any concerted work stoppage by employees. This includes a stoppage that results when a collective bargaining agreement expires or any other concerted slowdown or interruption of operations by employees.

Participating in a strike means an employee's refusal in concert with others to work.

Participation in a strike is not considered good cause for leaving employment. It is also not considered good cause for refusing to seek or accept other employment.

EXAMPLES:

1. Mrs. Jones is receiving RCA for herself and three (3) grandchildren. She is employed full time. On August 10th she goes on strike. How is the RCA case affected?

Mrs. Jones is removed from the assistance unit. Her portion of the August grant is recovered as an overpayment. Her portion is a pro rata share of the grant received.

2. The situation is the same as above except Mrs. Jones is the children's mother. How is the RCA case affected?

The case must be closed and the August payment recovered as an overpayment.

Note: If participation in a strike begins any time after the issuance of a grant, the entire month's grant for the affected individual must be recovered. This is true even if the strike begins on the last day of the month.

A striker who subsequently quits his job is no longer a striker and the strike provisions explained above no longer apply. In such cases, the DSS worker will verify that the individual has quit his job before any case changes are made.

**History**
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 1366 (06/01/11)*
- *9 DE Reg. 1237 (02/01/06)*

##### **16 Del. Admin. Code § 8000-8020** Application for Social Security Numbers {#sec-8000-8020 omnilex-key=us-de-regs-official--title-16--8000-8020}

Every applicant who does not have a valid Social Security Number (SSN) must apply for one before a public assistance application can be approved. Applicants who do not have a SSN are referred to the appropriate SSA District Office or branch office to apply for one via Form 122. Each person referred to the SSA to apply for a SSN is instructed to return verification of the number to DSS when the number is received.

In the case of newborn children, the mother of the child must apply for a card for the child by the first day of the second month following the month the mother is discharged from the hospital.

EXAMPLE: A child is born on May 25th and the child's mother is discharged from the hospital on May 28th. The mother must apply for a SSN and provide DSS with verification of the application by July 1.

Benefits must be denied to any person who refuses to furnish or apply for a SSN. In the case of a minor child, if a parent refuses to cooperate in applying for a SSN for the child, the parent(s), the child and all eligible siblings are ineligible for assistance.

8020.1 Procedures for Enumeration

Each applicant that does not have a SSN will be referred to the SSA to apply for a number as outlined below:

1. The worker informs the applicant at Intake that in order to be eligible for assistance, each family member must provide a Social Security Number or apply for a Social Security Number and report the assigned number to the agency.

2. The worker will complete Form 122 for clients who do not have a Social Security Number. The client is instructed to take the form to the SSA when applying for numbers, and is informed that SSA requires two (2) forms of identification for each person making application for a number, one of which must be a birth or baptismal certificate. Workers must emphasize that assistance cannot be approved until applications for missing numbers have been made and the completed Form 122 returned to DSS. A carbon or photocopy of the Form 122 is retained in the case record until the original is returned.

3. At intake, the worker allows the client thirty (30) days from the application filing date to apply for a Social Security Number and return a completed Form 122. In ongoing cases, the worker will give the client a deadline of not later than ten (10) days to apply for a Social Security Number and return the completed Form 122. If the client returns the Form 122 marked "The applicant was in to apply but no application has been made ....." the worker will not authorize assistance.

4. The above procedures apply to Social Security Numbers reported as missing on BENDEX report C35F1107 at redetermination, or at any other time it is discovered that a client does not have a Social Security Number and has not applied for one.

5. Clients who must apply for a Social Security Number are instructed to report the number to DSS as soon as it is received. Numbers will be verified through IEVS. See DSSM 2013.

**History**
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 1366 (06/01/11)*
- *9 DE Reg. 1237 (02/01/06)*

##### **16 Del. Admin. Code § 8000-8021** Assistance Units {#sec-8000-8021 omnilex-key=us-de-regs-official--title-16--8000-8021}

The assistance unit is defined as the total number of persons who are eligible for a separate grant under the particular category.

8021.1 Mandatory Composition of Assistance Units

In RCA, the assistance unit will always include:

1. The dependent child; and

2. The dependent child's blood‑ related or adoptive siblings who are under 18 and who are also dependent children; and

3. The dependent child's natural or adoptive parent(s). If both parents live in the home, both parents must be included in the unit regardless of the parents' marital status. In a case where paternity has not been legally established, the putative father must acknowledge paternity as a condition of eligibility.

Note: In 2 and 3 above, the child or parent must also reside in the home and be otherwise eligible. Examples of persons who are not otherwise eligible include, but are not limited to SSI recipients, Employment and Training sanctioned individuals, and individuals ineligible due to receipt of lump sum income.

EXAMPLE: In RCA, where children who live in the home include the caretaker's own children and a child who is related in some other manner (e.g., niece or nephew), establish two assistance units. One will include the caretaker and his/her children, and the other will include the other related child with the caretaker as payee only. When more than one such child lives in the home, each child will be placed in a separate assistance unit unless the children must be considered together as specified in 1 and 2 above.

8021.2 Optional Composition of Assistance Units

1. In RCA the dependent child, and if residing in the home and otherwise eligible, the child's blood‑ related or adoptive minor siblings, and the child's natural or adoptive parent(s) must be included in the unit. When both parents of the dependent child are in the home, both parents must be included in the unit regardless of their marital status. In a case where paternity has not been legally established, the putative father must acknowledge paternity as a condition of eligibility.

A Refugee non‑ parent needy caretaker relative may be included in the unit if the caretaker so chooses.

2. In RCA married couple cases, where each adult has children from previous relationships that are eligible for RCA, include the family in one RCA unit. If the couple has children in common who are also eligible for RCA, include these children in the unit also.

3. In RCA unmarried couple cases where each adult has children from previous relationships who are eligible for RCA, there will be two RCA grants ‑ one for each adult and that adult's child(ren). If the couple has children in common, who are eligible for RCA, the couple, their child and the children from previous relationships will be placed in one RCA unit.

4. The newborns are added to the unit, and a supplemental grant is effective the date of its birth if the birth is reported within five (5) days. If the birth is not reported within five (5) days, the child is added to the unit and the grant is effective as of the date of the report. The child's father, if he is otherwise eligible, is also added using these guidelines. Procedures for completing supplemental applications for newborns are outlined in DSSM 2000.6.

8021.3 Age as a Condition of Eligibility

For purposes of determining eligibility for cash grants, persons 18 years old and over are considered adults.

An individual is not eligible for RCA as a child the month of his/her 18th birthday if their birthdate is the 1st day of the month. If such children are RCA recipients, they will be removed from the assistance unit the last day of the month prior to the month of their 18th birthday.

An individual is eligible for RCA as the child the month of his/her 18th birthday if their birthday is the 2nd - 31st day of the month. If such children are TANF recipients, they will be removed from the assistance unit effective the last day of the month he/she turns 18.

An individual 18 years of age or older may still receive RCA as an adult.

8021.4 Eighteen Year Old Students

An 18 year old student who is still a full-time student in high school, GED, or equivalent program and will graduate prior to his/her 19th birthday may receive RCA as a child. The 18 year old would be removed from the assistance unit effective the last day of the month he/she graduates.

Example: Teen A will turn nineteen on October 3, 1994. Teen A will graduate from high school on June 14, 1994. Change Teen A's RCA Employment and Training code to J or K. When Teen A graduates on June 14, 1994, remove Teen A from the grant, effective June 30, 1994.

If the 18 year old originally scheduled to graduate prior to his/her 19th birthday but due to a change will now graduate after turning 19 years old, remove the 18 year old from the assistance unit.

Example: Teen C will turn nineteen on December 3, 1994. Initially, the school reported that Teen C would graduate on June 4, 1994. On March 4, 1994, we learn that Teen C will not graduate until June 4, 1995. Close Teen C in RCA, effective March 31, 1994.

8021.5 Minor Parent

An unmarried parent, under the age of 18, and the dependent child(ren) in his or her care is to reside in the household of a parent, legal guardian, other adult relative, or in an adult supervised supportive living arrangement to receive RCA benefits. The non-parent caretaker of a teen parent must show good cause why the teen is not living with his or her parent. Emancipated minors are considered adults for the purpose of establishing eligibility for assistance. An eligible emancipated minor may receive an assistance grant in his/her own name.

Emancipation must be documented in the case record. Acceptable documentation includes:

1) Court records; or

2) The minor's valid marriage license; or

3) Written statements from the Division of Family Services verifying the minor's emancipation.

If the minor parent and his or her children reside in an adult supervised supportive living arrangement, the Division of Family Services, within the Department of Services for Children, Youth and Their Families, must approve the living arrangement by the next redetermination. If the adult supervised supportive living arrangement is not approved by the next redeterminaton, RCA payments should be stopped.

Assistance is to be provided in the form of a protective payment to the minor parent's parent, legal guardian, other adult relative, or adult in the supervised supportive living arrangement.

**History**
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 1366 (06/01/11)*
- *9 DE Reg. 1237 (02/01/06)*

##### **16 Del. Admin. Code § 8000-8022** Cooperation With Quality Control Case Review {#sec-8000-8022 omnilex-key=us-de-regs-official--title-16--8000-8022}

A family is ineligible if it refuses to cooperate in any subsequent review of its eligibility as part of a Quality Control (QC) review. If the family is terminated for refusal to cooperate with a QC reviewer, the family may reapply but will not be determined eligible until it cooperates with the QC reviewer.

**History**
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 1366 (06/01/11)*
- *9 DE Reg. 1237 (02/01/06)*

##### **16 Del. Admin. Code § 8000-8023** Cooperation With Audit and Recovery Management (ARMS) - Investigations of Current Eligibility {#sec-8000-8023 omnilex-key=us-de-regs-official--title-16--8000-8023}

A family is ineligible if it refuses to cooperate in any investigation of current eligibility conducted by the Audit and Recovery Management Services (ARMS). If the family is terminated for refusal to cooperate in an ARMS investigation, the family may reapply but will not be determined eligible until it cooperates with the ARMS investigation of current eligibility. Assistance will not be terminated for refusal to cooperate with ARMS investigations of past eligibility.

**History**
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 1366 (06/01/11)*
- *9 DE Reg. 1237 (02/01/06)*

##### **16 Del. Admin. Code § 8000-8024** Determination of Financial Need {#sec-8000-8024 omnilex-key=us-de-regs-official--title-16--8000-8024}

The Delaware Code allows for aid to "needy persons" and charges DSS with the responsibility of providing needy persons with sufficient income to meet basic living requirements.

Need is measured in terms of money and is the difference between the person's available income and resources as defined by the Division, and the standard of need set forth in Division Policy. Each person must be in financial need before assistance is received and for as long as assistance continues.

In all categories of Public Assistance, the grant is an unrestricted cash payment that the client is free to spend as he desires, unless the payment is made as a protective payment.

Any family whose available resources in any month exceed $1,000 is not eligible for cash assistance. See DSSM 8026.2 for a complete definition of available resources.

A family is not eligible for cash assistance in any month that its total gross income is in excess of 185% of the RCA standard of need. A table follows. Gross income does not include Public Assistance payments, the step‑ parent disregards listed in DSSM 8029.2, excluded income listed in DSSM 8030 , and the first $50.00 of child support collected each month.

Family Size

185% of RCA Standard of Need

1

$ 371

2

$ 499

3

$ 625

4

$ 752

5

$ 878

6

$1,006

7

$1,132

**History**
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 1366 (06/01/11)*
- *9 DE Reg. 1237 (02/01/06)*

##### **16 Del. Admin. Code § 8000-8025** Family Budget Group {#sec-8000-8025 omnilex-key=us-de-regs-official--title-16--8000-8025}

Family budget group is the total number of persons whose needs and income are budgeted together. This will always include the following:

1. Married and civil union couples if they live together and are both eligible for a grant.

2. Couples who do not have legally recognized marriages/civil unions but who live together as husband and wife or spouses and are both eligible for a grant.

NOTE: In RCA, couples will be considered as living together as husband and wife if:

a. They say they are joined by a civil union or marriage even if the marriage/civil union cannot be verified, or

b. They are recognized as parties to a civil union, spouses, or husband and wife in the community, or

c. One partner uses the other's last name, or

d. They state they intend to marry/join in a civil union, or

e. They jointly hold resources.

3. Parents and their eligible children.

Family budget groups will consist of more than one assistance unit when all budget group members are not placed in the same assistance unit. In those instances, the need standard for the family cannot exceed the RCA need standard for the budget group size as specified in Section 8031.1 (See DSSM 8021)

In households that include a caretaker, the caretaker's children and other children that are the caretaker's responsibility, the caretaker's needs and income and those of his/her children are always budgeted together. The needs and income of any other children in the home will be considered separately. In these situations, the separate budget groups can be combined to form a single family budget group only when the following conditions are met:

1. Assistance would be denied to any of the recipients by maintaining separate budget groups.

2. . The caretaker understands the implications of combining the budget groups (i.e., lower assistance payments, increased Medicaid coverage, etc.) and chooses to have his/her needs and income and those of his/her children considered with the needs and income of any other children in the home.

**History**
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 1366 (06/01/11)*
- *9 DE Reg. 1237 (02/01/06)*

##### **16 Del. Admin. Code § 8000-8026** Resources {#sec-8000-8026 omnilex-key=us-de-regs-official--title-16--8000-8026}

8026.1 Potential Resources

Potential resources are resources that a client has claim to, but that the client does not directly possess. Examples of potential resources include a pending claim for RSDI, UC, or insurance benefits, an inheritance that has not been through probate, or a pending property settlement that is the result of a divorce action.

The following individuals must apply for Unemployment Compensation (UC):

Individuals whose hours are reduced by their employers; or

Individuals laid off by their employers.

These individuals must cooperate with the Department of Labor to determine if they are eligible for UC. Usually, the individual must keep two (2) appointments with DOL before their UC claim is processed.

When the Division learns that a client has a potential resource, the eligibility worker will establish when the resource will become available and set a control to monitor its availability. As a condition of eligibility, it is required that applicants and recipients accept the resource when it becomes available.

When the potential resource becomes available to the client, DSS will redetermine financial eligibility and make appropriate case changes.

All potential resources and the time of their future availability must be documented in the case record.

Interest or dividends from a potential resource that is not yet available is counted as income.

Accrued vacation and/or sick leave is treated as a potential resource when an applicant or recipient requests a leave of absence from employment for a specific period of time. The eligibility worker must request verification of the availability of payment for accrued leave time and require that the client take steps to receive the payment if it is available. The income when received will be treated as earned income if it is paid as a wage. It will be treated as unearned income if it is paid as a disability benefit through an insurance company.

8026.2 Available Resources

Any income or resource which a client actually has on hand for immediate use is an available resource. Cash on hand, checking accounts, any form of savings or bank accounts, State and Federal Income Tax Refunds, and the cash value of life insurance are examples of available resources.

NOTE: The cash value of life insurance is a resource for the person who owns the policy, not the individual for whom the insurance was purchased. For example, if Mary Smith owns an insurance policy for her daughter, Susan, that has a cash value of $500, the $500 is a resource for Mary.

If no owner is declared on an insurance policy, that policy automatically becomes the resource of the insured (e.g., the child) the month the insured/child becomes 18 years of age. If an owner (e.g., the parent/caretaker) is declared, that policy remains the resource of the owner until changed by the owner.

A family budget group is not eligible for cash assistance if its available resources exceed $1,000.

Available resources must be documented in the case record. Resources remaining in the applicant's country of origin are not considered available resources.

8026.3 Jointly Held Resources

The entire value of a jointly held resource is attributable to the public assistance applicant or recipient, unless the applicant or recipient can verify that the resource is not accessible to him/her.

EXAMPLE: A car is registered under the names of a husband and wife. If the couple separate and one partner keeps the car, the car is not accessible to the other partner.

This does not apply to bank or other financial accounts in which two names appear on the account, but one is held in trust for another.

8026.4 Resources Held on Behalf of Others

Resources held in the name of a client as the legal guardian, legal representative, next of kin of a minor child (other than his own or adopted child), or as holding power of attorney for another will not be considered as a resource to the client provided that the resource is so listed as to indicate that he is acting on behalf of another person.

8026.5 Excluded Resources

The equity value of real and personal property owned by a family budget group cannot exceed $1,000.00. Resources excluded from the $1,000.00 resource limitation are:

1. The home which is the usual residence of the family budget group.

2. One automobile, the equity value of which does not exceed $1,500.00. The equity value is the difference between the automobile's fair market value and the amount still owed for it. The equity value in excess of $1,500.00 is counted towards the $1,000.00 resource limitation. The entire equity value of other automobiles owned by the individual is counted as a resource.

NOTE: The fair market value of an automobile is determined by finding the car's trade‑ in value in the NADA Used Car Guide. If the client disagrees with this valuation, he/she may obtain a statement of the car's value from a automobile dealer.

The increased value of a motor vehicle specially equipped with devices for the handicapped is not counted. Farm vehicles that are used to produce income are excluded from consideration as a resource.

EXAMPLE: A client owns a car which has a fair market value of $5,000.00. The client owes $3,000.00 on it. The car's equity value is $2,000.00. Its resource value for financial assistance purposes is $500.00 ($2,000.00 ‑ $1,500.00).

3. One burial plot for each member of the assistance unit.

4. Bona fide funeral agreements (e.g., pre‑ paid burial contracts) up to a total of $1,500.00 for each member of the budget group.

NOTE: If a funeral agreement valued in excess of $1,500.00 includes both prepaid burial expenses and a burial plot, the worker will require that the client provide an itemized statement of the estimated value of the plot and the expenses. The value of the burial plot is an excluded resource and will be considered separately from the value of the prepaid expenses.

5. Basic maintenance items essential for day-to-day living such as clothes, furniture, and other similarly essential items.

6. For a period not to exceed six months, real property that is not used as a residence (see DSSM 8026.6 ).

7. Tools and equipment necessary to produce income in a self‑ employment enterprise, even if the owner is not engaged in business currently, but plans to continue it at a future date.

8. Federal major disaster and emergency assistance provided to individuals and families and comparable disaster assistance provided by State, local governments, and disaster assistance organizations under P.L. 100‑ 707.

"Emergency" means any occasion or instance for which, in the determination of the President, Federal assistance is needed to supplement State and local efforts and capabilities to save lives and to protect property and public health and safety, or to lessen or avert the threat of a catastrophe in any part of the United States.

"Major Disaster" means any natural catastrophe...which in the determination of the President causes damage of sufficient severity and magnitude to warrant major disaster assistance to supplement the efforts of available resources of states, local governments, and disaster relief organizations in alleviating the damage, loss, hardship, or suffering caused thereby.

9. All federal income tax refunds, including Earned Income Tax Credits (EITC).

The refund is disregarded regardless of whether the refund is a result of a refundable credit, over withholding, or both.

Federal tax refunds received during the previous 12 month period by any case member are disregarded.

10. A sponsor's resources cannot be considered available solely because the person is serving as a sponsor.

11. Cash value of Life Insurance Policies.

8026.6 Disposal of Real Property

Real property that is not used as a residence is excluded as a resource for a period not to exceed six months if the following conditions are met:

1. The family is making a good faith effort to sell the property. This effort must be documented in the case record. Examples of acceptable documentation include a current newspaper sales advertisement, or a current sales contract with a real estate firm; and

2. The family signs Form 212, an agreement to dispose of the property and to repay the assistance received during the exemption period.

The amount of assistance that must be repaid after the property is sold is determined as follows:

1. Compare the net proceeds of the sale plus the value of other countable resources available at the time the exemption period began to the $1,000 resource limit.

2. If the amount is less than $1,000, there is no overpayment.

3. If the amount is more than $1,000, the amount of the proceeds that is in excess of $1,000 is recovered as an overpayment. Note: The amount recovered cannot exceed the assistance that was received. Any proceeds in excess of the amount to be recovered are considered as an available resource to the family.

4. If the property is not sold within six months, the assistance case must be closed. All the assistance payments are overpayments.

5. If the assistance case is closed for some other reason during the six‑ month exemption period and the property has not been sold, all payments are overpayments.

NOTE: The exemption period runs for six calendar months. If the assistance case closes and the client reapplies during this period, the exemption will continue for the remainder of the initial six‑ month period.

8026.7 Transfer of Resources

Any individual who transfers a resource valued at more than $500 without fair market consideration is ineligible for RCA for two (2) years from the date of the transfer.

**History**
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 1366 (06/01/11)*
- *9 DE Reg. 1237 (02/01/06)*

##### **16 Del. Admin. Code § 8000-8027** Income {#sec-8000-8027 omnilex-key=us-de-regs-official--title-16--8000-8027}

Income is any type of money payment that is of gain or benefit to a family. Income is either counted or excluded in the budgeting process.

A family's countable income less disregards is subtracted from the applicable standard of need to determine the amount of the assistance grant. If a mandatory member of an RCA unit is sanctioned by removal from the assistance unit because he/she failed without good cause to cooperate with the Employment & Training Program, the individual's income is considered available to meet the needs of the remaining members of the RCA unit. The gross income without any deductions or disregards is subtracted from the needs of the remaining unit members to determine the amount of the grant.

All countable income must be documented in the case record. (Information obtained through IEVS on UC and RSDI benefits is verified. No other documentation is needed in the case record. See DSSM 2013 . See DSSM 2013.5 regarding special processing instructions for applicants claiming RSDI benefits.)

8027.1 Casual and Inconsequential Income

Income which is casual and inconsequential will not be considered as available income. Casual or inconsequential income is defined as income which is under $30 per recipient per calendar quarter, non‑ recurrent, and usually unpredictable, such as a holiday, birthday, or graduation gift. The income from a gift can be divided among the members of the budget group if the recipient of the gift claims it was intended for all of the group members.

EXAMPLE: Mr. & Mrs. Jones receives a $150 Christmas gift. The gift is intended to be used for Mr. & Mrs. Jones and their four (4) children who receive RCA. All of this income can be disregarded since it does not exceed $30 per recipient when divided among the RCA budget group members.

8027.2 Budgeting Income of a Payee Only Parent

All of the income of a parent who lives in the home and who is not a recipient of TANF, GA, or SSI, but whose child receives TANF or GA is attributable to the child and budgeted. No disregards are deducted from the parents' income.

**History**
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 1366 (06/01/11)*
- *9 DE Reg. 1237 (02/01/06)*

##### **16 Del. Admin. Code § 8000-8028** Earned Income {#sec-8000-8028 omnilex-key=us-de-regs-official--title-16--8000-8028}

Earned income is the money an individual receives in return for work he/she performs. Earned income entitles the earner, who is a member of an assistance unit, to deductions that are not allowed for unearned income.

8028.1 Sources of Earned Income

1. Wages ‑ Gross earnings paid to the employee before deductions for taxes, FICA, insurance, etc. are counted. Sick pay or vacation pay is considered as a wage as long as it is paid as a wage. If sick pay is paid through an insurance company as disability pay, it is considered unearned income.

NOTE: Earnings paid to employees under contract are averaged over the number of months covered by the contract.

EXAMPLE: A teacher is under contract for a full calendar year, but may choose to collect his pay during the school year. His wages for public assistance purposes are budgeted over the full year.

2. Self‑ employment ‑ Gross earned income from self‑ employment is determined by subtracting business expenses (supplies, equipment, etc.) from gross proceeds. The individual's personal expenses (lunch, transportation, income tax, etc.) are not deducted as business expenses but are deducted by using the standard allowance for work connected expenses (See DSSM 8028.2 and DSSM 8028.3).

Self-Employment Standard Deduction for Producing Income

The cost for producing income is a standard deduction of the gross income. This standard deduction is a percentage of the gross income determined annually and listed in the Cost-of-Living Adjustment (COLA) notice each October.

The standard deduction is considered the cost to produce income. The gross income test is applied after the standard deduction. The earned income deductions are then applied to the net self-employment income and any other earned income in the household.

The standard deduction applies to all self-employed households with costs to produce income. To receive the standard deduction, the self-employed household must provide and verify they have business costs to produce income. The verifications can include, but are not limited to, tax records, ledgers, business records, receipts, check receipts, and business statements. The self-employed household does not have to verify all their business costs to receive the standard deduction.

Self-employed households not claiming or verifying any costs to produce income will not receive the standard deduction.

The self-employment standard deduction will be reviewed annually to determine if an adjustment in the percentage amount is needed.

8028.2 Earned Income Disregards in RCA

The following disregards are deducted from gross earned income in the RCA budgeting process. Disregards are applied to each earner's wages.

1. Standard allowance for work connected expenses - $90.00.

2. The $30 plus 1/3 disregard. This disregard allows the deduction of $30 plus 1/3 of the remaining earned income after the standard allowance for work connected expenses is subtracted.

The $30 plus 1/3 disregard is applied to earned income for four (4) consecutive months. If TANF benefits end or employment ends before the fourth month, the earner is eligible for the disregard for four (4) additional months upon reapplication or re-employment.

When a case suspends for one (1) month because the earner received an extra paycheck, the month of suspension does not count as one of the four (4) consecutive months. The count picks up when the case is reinstated.

EXAMPLE: A case is budgeted in May and June with $30 plus 1/3 disregard. In July, the case is suspended because of an extra paycheck. In August, the case is reinstated and the $30 plus 1/3 disregard is again applied. August is the third month of the four (4) consecutive months.

When an earner's wages are so low ($90 or less in the month) that the income is zero before any part of the $30 plus 1/3 disregard can be applied, that month does not count as one of the four (4) consecutive months of the $30 plus 1/3.

EXAMPLE: A case is budgeted in May and June with the $30 plus 1/3 disregard. In July, the client earns $75. In August, the client earns $120. August is the first month of the four (4) consecutive months of the $30 plus 1/3.

3. The $30 disregard. After the $30 plus 1/3 disregard has been applied for four (4) consecutive months, the 1/3 disregard is removed from the budget. The $30 disregard continues to be deducted from earned income for the eight (8) months. The $30 disregard is not repeated if an individual stops working or TANF benefits end before the completion of the eight (8) months. If benefits end and the client reapplies, the $30 disregard from earned income is continued until the end of the original eight (8) months.

Unlike the $30 plus 1/3 disregard which is dependent upon the client having sufficient earned income and being a TANF recipient, the $30 disregard is for a specific time period. This time period begins when the $30 plus 1/3 disregard ends and is not dependent upon the client having earned income or receiving TANF.

NOTE: When an earner has received the $30 plus 1/3 disregard in four (4) consecutive months and the $30 deduction has been available for eight (8) additional months, neither disregard can be applied to earned income until the individual has not received TANF benefits for twelve (12) months.

4. Dependent care expenses as paid up to $200 per month per dependent child under age two (2) and up to $175 per month per dependent child or incapacitated adult. The dependent child or incapacitated adult must be living in the home and receiving TANF for the earner to receive this deduction.

8028.3 Earned Income Disregards - Reducing Employment

Earned income disregards (the standard allowance for work expenses and dependent care costs), are not deducted from earnings when a recipient quits a job without good cause, or reduces earnings without good cause.

Good cause for reducing earnings includes circumstances beyond the individual's control such as, but not limited to illness, illness of another family member requiring the wage earner's presence, a household emergency, the unavailability of transportation, or the lack of adequate child care.

Good cause for terminating employment includes those circumstances listed above. It also includes:

1. Discrimination by an employer based on age, race, sex, handicap, religious belief, national origin, or political belief.

2. Work demands or conditions that are unreasonable such as working without being paid on schedule.

3. Acceptance of other employment or enrollment at least half‑ time in a school, training program or college.

4. Resignations by persons under the age of 65 which are recognized by the employer as retirement.

5. Leaving a job in connection with patterns of employment in which workers move from one employer to another as in migrant farm labor or construction work.

8028.4 Earned Income Tax Credit (EITC)

All EITC payments received by an RCA applicant or recipient are disregarded as income for eligibility and payment purposes. EITC payments are also excluded when determining a family's eligibility under the 185% gross income test.

EITC payments are not defined as earned income in the RCA Program even though advance EITC payments are made by the employer.

8028.5 Minor Student Earned Income

Exclude the earnings of a full time student from both the 185% gross income test and the net income test for six (6) months per calendar year. This exclusion is based on the child's full time student status, not the type of earnings. The income exclusion applies to both applicant and recipient full time students.

For applicants in which the six (6) month income exclusion time period has ended, the earned income of a child who is a student is included in determining the RCA assistance unit's financial eligibility. If the unit is financially eligible, the students' earned income is disregarded in determining the amount of the grant.

For active cases in which the six (6) month income exclusion time period has ended, the earned income of a child who is a student is included in the 185% gross income test. If the RCA unit's income is less than the 185% gross income limit, the student's earned income is disregarded in all further budget calculations.

A minor student is defined as a child who attends a school or a vocational training course full time. Student status is also extended to a child who attends school part time if the child is not a full time employee. Part-time school attendance is defined as carrying at least half of a full time schedule. Full-time employment is defined as working more than thirty (30) hours per week.

NOTE: The earned income a minor receives as a participant in the WIA sponsored Summer Youth Employment is disregarded in all income tests. (See DSSM 8030).

**History**
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 1366 (06/01/11)*
- *9 DE Reg. 1237 (02/01/06)*

##### **16 Del. Admin. Code § 8000-8029** Unearned Income {#sec-8000-8029 omnilex-key=us-de-regs-official--title-16--8000-8029}

Unearned income is income received without performing work‑ related activities. Unearned income is counted as paid without the application of any disregards in the RCA program.

Unearned income includes but is not limited to:

8029.1 Child Support Payments in RCA Program

In the RCA Program, the first $50.00 of child support received in a month is disregarded in determining financial eligibility. Child support in excess of $50.00 is counted as unearned income. If a unit is determined financially eligible, child support is disregarded in determining the amount of the grant.

For active cases, child support is collected and retained by the Division of Child Support Enforcement. The first $50.00 of child support that is collected each month by DCSE is paid to the RCA payee as a bonus check. If the amount of support collected is less that $50.00, the bonus check will equal the amount collected.

Bonus checks are paid the month following the month that the DCSE collects support. They are disregarded in determining RCA financial eligibility and grant amounts; however, they are counted as unearned income in the Food Stamp Program.

In the month of application if support is received prior to approval of an RCA grant, the support received minus the $50.00 child support disregard is budgeted as unearned income. Support received after approval of the grant is subject to collection by the DCSE.

EXAMPLE: A woman applies for RCA for herself and her children on 2/15. She reports that she received a $100.00 support payment on 2/10 and expects to receive an additional $100.00 on 2/24. She is found eligible for RCA on 2/15. In February, $50.00 of child support is included in the RCA budget as unearned income. ($100.00 received prior to approval of the grant ‑ $50.00 disregard = $50.00 budgetable.) The recipient will receive a $50.00 bonus check in March based on the $100.00 payment collected by the DCSE on 2/24.

8029.2 Step Parent Income in RCA Program

In the RCA Program, a step‑ parent who resides with his/her step‑ children is considered responsible for supporting those children. A portion of the step‑ parent's income is used to determine the step‑ children's financial eligibility and the amount of assistance the children receive. To determine the amount of the step‑ parent's income that is deemed to the assistance unit, follow the steps listed below:

NOTE: The assistance unit must include the step‑ child, the step‑ child's natural or adoptive parent, and siblings who are also living in the home and who are otherwise eligible.

1. Determine the step‑ parent's gross income.

2. Deduct $90.00 from earned income.

3. Deduct the RCA standard of need (See DSSM 8031.1 ) for the family size that includes the step‑ parent and those individuals who

a. live in the step‑ parent's home

b. are the step‑parent's dependents for income tax purposes

c. are not members of the RCA assistance unit.

(These individuals cannot include a person who is removed from the RCA unit because he/she failed without good cause to cooperate with DCSE or the First Step Program and is being sanctioned.)

4. Deduct amounts paid by the step‑ parent to individuals who are not living in the home, but who are claimed as dependents for income tax purposes.

5. Deduct child support or alimony payments made to individuals not living in the home.

The remainder is unearned income used to determine the assistance unit's financial eligibility and grant amount.

Summary ‑ Total Income

- $90.00 from earned income

- Standard of Need

- Payments to dependents

- Countable Income

The resources of a step‑ parent are not considered in determining the financial eligibility of the assistance unit. Resources held jointly by the step‑ parent and the step‑ parent's spouse are considered available in their entirety to both partners. If the spouse is a member of the assistance unit, these resources are considered in determining the unit's eligibility.

Step‑ parent budgeting is used to determine the financial eligibility of a step‑ child even if the step‑ child's natural parent does not reside in the home.

NOTE: If the step‑ parent is included as a member of the RCA unit, his/her income is budgeted in accordance with rules governing the income of RCA applicants and recipients.

8029.3 Income of a Minor Parent's Parent or Legal Guardian in RCA Program

To determine the financial eligibility of an RCA unit that consists of a dependent child and the child's minor parent (under age 18), the income of the minor parent's parent(s) or legal guardian must be considered if the minor parent and his parent or legal guardian live in the same home. The portion of the parent's or guardian's income that is counted as unearned income to the assistance unit is determined by following the procedures for budgeting step‑ parent income.

In a case where both parents of the minor child reside in the home and each parent has earned income, each parent is entitled to a $90.00 deduction from wages.

The resources of a minor parent's parent or legal guardian are not considered in determining the financial eligibility of the assistance unit.

**History**
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 1366 (06/01/11)*
- *9 DE Reg. 1237 (02/01/06)*

##### **16 Del. Admin. Code § 8000-8030** Excluded income {#sec-8000-8030 omnilex-key=us-de-regs-official--title-16--8000-8030}

The following kinds of income are disregarded in determining financial eligibility and grant amounts in RCA:

EXAMPLE: A friend pays a recipient's electric bill. The payment is made directly to the electric company. This payment is not considered as income to the assistance unit.

1. Written agreement between the client and the individual or establishment engaged in the business of making loans to repay the money within a specified time.

2. If the loan is obtained from an individual or establishment not normally engaged in the business of making loans, obtain one of the following:

a. Borrower's acknowledgement of obligation to repay; or

b. Borrower's expressed intent to repay either by pledging real or personal property or anticipated income; or

c. A written statement detailing borrower's plans to repay the loan when future anticipated income is received.

"Emergency" means any occasion or instance for which, in the determination of the President, Federal assistance is needed to supplement State and local efforts and capabilities to save lives and to protect property and public health and safety, or to lessen or avert the threat of a catastrophe in any part of the United States.

"Major Disaster" means any natural catastrophe...which in the determination of the President causes damage of sufficient severity and magnitude to warrant major disaster assistance to supplement the efforts of available resources of states, local governments, and disaster relief organizations in alleviating the damage, loss, hardship, or suffering caused thereby.

Kingswood Community Center

Peoples' Settlement Association

Catholic Social Services, Inc.

Neighborhood House, Inc.

Community Housing, Inc.

Jewish Family Service of Delaware

Salvation Army

Community Action (Sussex County)

8030.1 Excluded Income - Grants and Loans to Students

Grants and loans to undergraduate students for educational purposes that are made or insured by programs administered by the United States Commissions of Education are disregarded. These include Basic Educational Opportunity Grants (BEOG), Supplemental Education Opportunity Educational Grants (SEOG), National Direct Student Loans (NDSL), Guaranteed Student Loans (GSL), all funds provided under the National Defense Education Act, and earnings from federally financed college work study.

For other grants, loans, or unearned income that is contingent upon attending a school, college, university, or course of vocational training, that part that is available for current living expenses is counted as income. To determine the amount that is available, subtract expenses for tuition, books, fees, equipment, special clothing needs, transportation to and from school, and child care necessary to attend school from the amount of the loan, grant, or other benefit. Divide the balance by the number of months the income is intended to cover to determine budgetable monthly income.

NOTE: When a student's financial aid package includes both loans and grants that are completely disregarded and those that are countable after expenses are deducted, determine countable income as follows:

1. Compare expenses to disregarded loans or grants.

2. If expenses are less than or equal to disregarded funds, all other grants and loans are budgeted as unearned income.

EXAMPLE:

Pell Grant

$442.00

disregarded

De. Post Secondary Grant

234.00

countable

Minority Scholarship

166.00

countable

842.00

Tuition and books

409.00

allowable expenses

Expenses ($409) are less than disregarded grant ($442). Budgetable income is all other grants, loans or benefits ($234 + $166 = $400)

3. If expenses exceed disregarded funds, budgetable income is determined by finding the difference between disregarded funds and allowable expenses and subtracting that amount from all other funds.

EXAMPLE:

Pell Grant

$442.00

disregarded

De. Post Secondary Grant

234.00

countable

Minority Scholarship

166.00

countable

$842.00

Tuition, books, and day care

$450.00

allowable expenses

Allowable expenses ($450.00) exceed disregarded funds ($442.00) by $8.00

Countable grants

$400.00

($234 + $166)

Difference

8.00

Budgetable Income

$392.00

**History**
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 1366 (06/01/11)*
- *9 DE Reg. 1237 (02/01/06)*

##### **16 Del. Admin. Code § 8000-8031** RCA Standard of Need/Payment Standard {#sec-8000-8031 omnilex-key=us-de-regs-official--title-16--8000-8031}

The Standards of Need that follow include allowances for food, clothing, utilities, personal items, and household supplies.

Delaware's payment standard is 100% of the applicable standard of need.

A family or individual is not eligible to receive assistance if income, after disregards are subtracted, exceeds the applicable standard.

The amount of the assistance grant is determined by subtracting countable income from the applicable standard. Grants are not issued in amounts less than $10.00.

8031.1 Standard of Need Chart

Number in Budget

Basic Personal Needs, Including Shelter and Utilities

1

$201.00

2

270.00

3

338.00

4

407.00

5

475.00

6

544.00

7

612.00

Over 7 in budget add $69.00 per person to total for items for family of seven.

**History**
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 1366 (06/01/11)*
- *9 DE Reg. 1237 (02/01/06)*

##### **16 Del. Admin. Code § 8000-8032** Determining Financial Eligibility and Grant Amounts in RCA {#sec-8000-8032 omnilex-key=us-de-regs-official--title-16--8000-8032}

The two tests for financial eligibility are the gross and net income tests. Comparing the family's income to 185% of the applicable standard of need is the gross income test. Comparing the family's income after certain disregards to the applicable standard of need is the net income test. The net income test is different for families receiving RCA or having received RCA in the past four (4) months and families who have not received RCA in the past four (4) months. A family's income must be less than both the gross and net income limits to be financially eligible. Once financial eligibility is established, determine the grant amount.

Gross income is the total of the earned income and unearned income. Wages and self‑ employment income are examples of earned income (DSSM 8028.1). Social Security benefits, child support minus the first $50, and step‑ parent income are examples of unearned income (DSSM 8029 ‑ 8029.3.) Include step‑ parent income even when the step‑ child's natural parent does not live in the home. Section 8 housing subsidies, foster care payments, and the value of food stamps are examples of excluded income (DSSM 8030).

GROSS INCOME TEST

Compare gross income to 185% of the applicable RCA standard (DSSM 8031.1). Deny assistance if income exceeds 185% of the applicable RCA standard.

NET INCOME TEST

Net income test for applicants who have not received assistance in the past four (4) months.

·

From earned income, subtract the standard allowance for work‑ connected expenses.

·

From remaining earned income, subtract payments for dependent care.

·

Add remaining earned income to the unearned income.

·

Compare the sum to the applicable RCA standard of need. Deny assistance if the income exceeds the RCA standard.

Net income test for applicants who have received assistance in the past four (4) months or recipients.

BENEFIT CALCULATION

Subtract this income from the applicable RCA standard of need.

**History**
- *15 DE Reg. 1498 (04/01/12)*
- *14 DE Reg. 1366 (06/01/11)*
- *9 DE Reg. 1237 (02/01/06)*

#### **10000** Supplemental Nutrition Assistance Program Employment and Training (SNAP E&amp;T)

##### **16 Del. Admin. Code § 10000-10001** Defining the SNAP E&T Program {#sec-10000-10001 omnilex-key=us-de-regs-official--title-16--10000-10001}

7 CFR 273.7

The statewide SNAP E&T program supports SNAP recipients by providing skill development, training, and work

experience opportunities that can lead to self-sustaining employment.

1. The SNAP E&T program promotes the self-sufficiency of SNAP recipients by:

10001.1 Defining SNAP E&T Program Terms

7 CFR 271.2, 7 CFR 273.7

This policy contains terms and definitions for the SNAP E&T program.

“ABAWD” means an able-bodied adult without dependents. An ABAWD is a SNAP applicant or recipient who is:

“ABAWD Work Requirement” means a mandatory condition that an ABAWD client must comply with to maintain eligibility for food benefits that includes completing 20 or more hours per week in one or a combination of the following activities:

“Adult Basic Education” or “ABE” means academic instruction in basic skills to improve an individual’s employability.

“Adverse Action” means a negative action to a client’s benefit case.

“Application for Social Services and Internet Screening Tool” or “ASSIST” means an online self-service portal that allows individuals to apply for health and social service benefits in Delaware.

“Assessment” means an in-depth evaluation of an individual’s skills and employment interests.

“ASSIST Worker Web” or “AWW” means the system that DSS uses to screen and determine benefit eligibility.

“At-risk ABAWD” means an ABAWD client who is in the third month of the three-month time limit for receiving food benefits while not complying with the ABAWD work requirement.

“Case Management” means a process that includes assessment, planning, monitoring, and service coordination to assist an individual in achieving employment goals.

“Component” means an approved element or activity for SNAP E&T participants.

“Custodial Parent” means a parent who has custody of a child and is primarily responsible for the daily care of the child.

“Delaware JobLink” means a web-based employment and labor market information system maintained by the Delaware Department of Labor. Delaware JobLink provides job postings, employment resources, and training opportunities.

“Department of Education” or “DOE” means the Delaware agency that the SNAP E&T program collaborates with to provide basic education programs to SNAP E&T participants.

“Department of Health and Social Services” or “DHSS” means the Delaware agency that administers services that promote health and well-being, foster self-sufficiency, and protect vulnerable populations.

“Department of Labor” or “DOL” means the Delaware agency that the SNAP E&T program collaborates with to provide employment and training resources to SNAP E&T participants.

“Dependent Care” means child care or adult care.

“Division of Social Services” or “DSS” means a division within DHSS that is responsible for administering certain public assistance programs, including SNAP food benefits and the SNAP E&T program.

“Education” means educational programs intended to enhance an individual's employability and includes:

“English as a Second Language” or “ESL” means the study of the English language by individuals who have a limited ability in speaking, reading, writing, or understanding the English language.

“Exempt” means a SNAP applicant or recipient is not required to comply with SNAP work requirements or with the SNAP E&T program.

“Federal Fiscal Year” or “FFY” means the period of October 1 through September 30.

“Food and Nutrition Service” or “FNS” means the federal agency within the United States Department of Agriculture (USDA) that is responsible for the administration of SNAP.

“Food Supplement Program” or “FSP” means Delaware’s nutrition assistance program that provides SNAP food benefits to eligible individuals.

“General Educational Development” or “GED” means a credential that certifies that an individual has academic knowledge and skills equivalent to a high school graduate.

“Good Cause” means an adequate or substantial reason why an individual has not taken an action. DSS will determine good cause on a case-by-case basis.

“Job Retention” means services intended to help an individual maintain employment.

“Job Search” means job-seeking activities intended to enhance an individual’s employability.

“Sanction” means a penalty for failing to comply with SNAP work requirements without good cause.

“SNAP Employment and Training” or “SNAP E&T” means the DSS program that supports food benefit recipients by providing skill development, training, and work experience opportunities that can lead to self-sustaining employment. This program is also known as Food Benefit Employment and Training (FB E&T).

“SNAP Work Requirements” mean mandatory conditions that a work registrant must comply with to maintain eligibility for food benefits that include:

“Suitable Employment” means employment that has an adequate wage and acceptable working conditions. DSS will determine the suitability of employment on a case-by-case basis.

“Supplemental Nutrition Assistance Program” or “SNAP” means the federal program that provides nutrition assistance to low-income individuals and families so they can purchase healthy food and move toward self-sufficiency.

“Supportive Service” means a service provided to an individual that is necessary for participation in the SNAP E&T program or for employment.

“Temporary Assistance for Needy Families” or “TANF” means a state and federally funded program established by Title IV-A of the Social Security Act and authorized by Title 31 of the Delaware Code to provide benefits to low-income families with dependent children.

“Vocational Rehabilitation” or “VR” means a program that helps individuals with physical or mental disabilities to obtain and retain employment.

“Work Experience” means activities such as on-the-job training, pre-apprenticeship, apprenticeship placements, and internships that allow an individual to learn vocational skills.

“Work Registrant” means a non-exempt SNAP applicant or recipient mandated to comply with SNAP work requirements.

“Workfare” means supervised work performed at a public or private non-profit organization in which an individual receives compensation in the form of a monthly food benefit allotment instead of wages. Workfare is for ABAWD clients only.

“Workforce Innovation and Opportunity Act” or “WIOA” means federal legislation that coordinates workforce development programs and funding streams.

**History**
- *23 DE Reg. 873 (04/01/20)*
- *23 DE Reg. 873 (04/01/20)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *10 DE Reg. 1708 (05/01/07)*

##### **16 Del. Admin. Code § 10000-10002** Program Components {#sec-10000-10002 omnilex-key=us-de-regs-official--title-16--10000-10002}

Food Stamp Employment and Training components include the following:

A. Independent Job Search: A job seeking activity initially engaged in by all registrants.

B. Self-Directed Job Search Training: Job seeking and job holding instruction designed to equip registrants with successful techniques for finding employment.

C. Basic Life Skills Enrichment: Individualized and small group academic and life skills instruction to registrants with deficiencies which pose as barriers to employment.

D. Post-Secondary Education: Case managed referrals of registrants who possess the requisite skills to post-secondary educational programs. Such educational programs are intended to enhance a registrant's employability and will, as much as is reasonably possible, lead to employment. Managing of referrals includes monitoring of each participant's attendance and progress.

E. Adult Education Through WIA and Other Education Programs: Case managed referrals of registrants to WIA or other educational programs for basic education or high school equivalency achievement. Managing of referrals includes monitoring of each participant's attendance and progress.

F. Vocational Training Through Workforce Investment Act (WIA) and Other Training Programs: Case managed referrals of registrants to WIA and other training programs which includes monitoring of each registrant's participation.

Other employment programs are also utilized. The Division is committed to maximizing its use of existing resources. The Division will not duplicate services funded by other programs. For this reason, the Division uses employment and training programs funded through the Delaware Private Industry Council (DPIC), Delaware Department of Labor, and Department of Education (DOE). Under a joint agreement between the Council and the Department of Labor, these two entities administer the funds available to the State through the WIA. Programs operated with WIA funds provide occupational training skills, academic training as necessary, and other supportive services to unskilled adults entering Delaware's labor force.

The Division works as a close partner with existing private and public agencies charged with providing employment and training help to TANF, Food Stamps, and General Assistance recipients. For instance, the Division continues to participate as a member agency to the Private Industry Council; staff members from the Division continue to assist the Delaware Private Industry Council in selecting WIA contractors. The Division also utilizes the services of both the Delaware Labor Department and the Private Industry Council when helping registrants identify jobs which are available or likely to become available in the labor market. Inter-agency agreements exist between the Division and the Private Industry Council to provide appropriate employment and training services to TANF, Food Stamps, and General Assistance recipients to share information and to avoid duplication of services wherever possible.

The Division also operates both its FSE&T - TANF and Food Stamp Employment and Training Plans in accordance with the Governor's Coordination and Special Services Plan. This Plan, put together by the State Job Training Coordinating Council under the auspices of the WIA, is the State's response to addressing the training and retraining needs of youth and adults who are unable to find productive employment because of the lack of skills, obsolescence of skills, or other barriers to employment.

The Division operates its Food Stamp Employment and Training Program in concert with its FSE&T - TANF Program. Both programs share the Employment and Training name as well as maintain a common administrative structure. Administrative supervision of the Division's employment and training programs operate under the umbrella of the Division's Program Implementation Unit. This unit shares assessment and employability planning instruments, case management techniques, a common referral mechanism, a common information system, and common support structure for activities such as child care.

10002.1 Sequencing of Components

The assignment of registrants to components does not necessarily follow a particular sequence. However, in the case of a registrant with low performance levels, there is an intent to follow a set sequence of activities. In this case, after an assessment the registrant would enter basic life skills enrichment, self-directed job search training, and vocational skills training. Because we know that the literacy and employability levels of many Food Stamp registrants are severely deficient, we anticipate that such registrants will remain in components much longer than usual.

All registrants initially enter an Independent Job Search component. This enables the Division to continue its expeditious processing of registrants and to maintain its participation rate.

10002.2 Components and Support Activities Summary

Each component and corresponding support activities are discussed in the following subsections.

10002.2.1 Job Search

The job search component is completed by the participant through Independent Job Search. This is a non-work component in which all newly work registered, mandatory participants are required to engage in job seeking activities. Prior to an initial interview with a Case Manager, registrants make at least 24 job contacts over a two week period. An interview with the Case Manager ultimately determines if the job search activity should continue or another activity is more appropriate.

Initially, 24 job contacts are required over a two week period. If the 24 contacts are not completed prior to the registrant's initial interview with a Case Manager, the registrant is given an additional two weeks to complete this activity. The interview with the Case Manager determines if the job search activity should be continued or another activity is more appropriate. Maximum duration of the component is 2 months, with the registrant completing 48 contacts.

Registrants are asked to complete a job search log, denoting the date, name, and address of employers contacted and the outcome of the contact. Registrants bring the log to their initial interview. Case Managers make random calls to employers to verify the contact.

10002.2.2 Job Search Training

The job search training component is completed by the participant through Self-Directed Job Search Training. This component is a non-work component designed to teach registrants to market their skills into meaningful, unsubsidized jobs. It consists of classroom instruction, direct use of job search tools, employer contacts, and feedback to participants.

The following areas are part of the classroom instruction: personal inventory of work skills, how to use community resources, how to use want ads, use of proper telephone techniques, letter writing, interview techniques, and application of job searching skills. By the end of the course, every registrant has a completed resume for their own use, took part in a videotaped mock interview, and met the employer contact requirements of the job search component.

During the approximate two month period for this activity, registrants obtain sufficient job seeking and job holding skills to enable them to successfully navigate the job market. Registrants commence job search activities only after they have made sufficient progress in their classroom instruction. Registrants have four hours of contact with a program vendor staff member in which they are provided with job lists, want ads, telephone books and other job search-related tools. The remaining time consists of contacts with employers and discussion with vendor staff.

Participation maximum is 120 hours over a two month period of time, averaging 60 hours per month. The duration is three weeks of actual classroom instruction, followed by five weeks of actual job searching activity.

10002.2.3 Education

A. Basic Life Skills Enrichment

The type of education activity for this component is Adult Basic Education. The purpose is to provide academic instruction to individuals with severe academic deficiencies which pose a significant barrier to employment. The basic academic instruction is applied to real life experiences which involve management of life skills. This instruction differs substantially from the typical adult basic education program. Classes are held year round, many classes take place during the day. The basic skills offered have measurable objectives which relate to an individual education plan, and the goal is placement in either a job or training which leads to a job. There are two parts to this education component. The first is basic remedial job related literacy and computational skills, and the second is life management skills.

Participation is for 15 hours per week for 36 weeks, or until the participant reaches the appropriate level of competency to be employed or enter vocational skills training. The duration is 15 hours per week for 36 weeks.

The goal of this component is employment or training which leads to employment. The skills taught link to critical job related needs and help to direct registrants to jobs which are within their level of functioning.

B. Post-Secondary Education

The type of education activity for this component is Post-Secondary Education with an emphasis on specific technical and occupational instruction, such as nursing, child care or computer science. Pursuance of a graduate degree is not an allowable activity. The educational institution must either be accredited or maintain a favorable reputation. Registrants must possess the necessary skills to be able to participate. Payment of tuition is not a reimbursable expense.

The targeted population includes those registrants who possess the necessary skills, as determined by their assessment.

Registrants attend as required by the institution, and must make satisfactory progress. If this level of effort exceeds 120 hours per month, the registrant completes a form indicating this and their reasons for doing so. The duration is determined by the program of instruction and the institution. There should be a reasonable expectation that the course of instruction will lead to the prospect of a job within a reasonable timeframe. (An appropriate example is a 2 year program leading to a nursing degree).

The course of study must be consistent with individual registrant's employment goals and should provide each registrant with a reasonable opportunity for employment.

C. Adult Education Through WIA and Other Educational Programs

Education activities include Adult Education activities that enable registrants to attain minimum recognized levels of competencies in subject areas such as reading, writing, communication, problem solving, critical thinking and math. Competency in these areas is considered critical if registrants are to compete for available jobs in the work force. The programs consist of a variety of adult basic education programs, high school equivalency programs, and adult high school, credit-oriented programs, such as Groves High School.

Participation is up to 15 hours per week for the length of the program as determined by program requirements. Duration is determined by program requirements.

The course of study provides registrants with basic skills required by most employers, such as a high school diploma and the ability to read and write.

10002.2.4 Vocational Training

Vocational Training activities include Vocational Skills Training through WIA and other training programs. Case managed referrals to WIA and other training programs consists of referral and monitoring of registrants referred by vendors to WIA or other training programs. Training is consistent with jobs that are available or are likely to become available in the local labor market. The Division ensures registrant compliance with enrollment and participation requirements by having signed agreements with contractors. These agreements allow contractors to provide the Division with reports of each registrant's progress and to notify the Division as soon as reasonably possible when a registrant is not complying.

Hours of participation are consistent with WIA program requirements. Registrants who choose to enroll in job training programs that exceed the required 120 hours per month will be asked to complete a form which indicates their desire to do so. Duration is a one to three month course, 12 hours per week.

The targeted population includes registrants who have completed basic life skills enrichment and require vocational skills training to enhance their employability, and those who have not been successful in locating employment while participating in group job search training.

**History**
- *23 DE Reg. 873 (04/01/20)*
- *23 DE Reg. 873 (04/01/20)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *10 DE Reg. 1708 (05/01/07)*

##### **16 Del. Admin. Code § 10000-10003** Program Exemptions {#sec-10000-10003 omnilex-key=us-de-regs-official--title-16--10000-10003}

Food Stamp recipients are required to participate in the Food Stamp Employment and Training Program unless they meet certain categorical and personal characteristics, and specific exemption criteria as identified below.

10003.1 Categorical and Personal Exemptions

Federal regulations requires that certain categorical and individual requirements must be met before an individual can be considered exempt from the Food Stamp Employment and Training Program. These requirements include the following:

A. Categorical Exemptions:

Federal requirements allows categories of persons to be exempt, including:

1. those for whom an employment and training requirement would be impractical, and

2. for factors such as the availability of work opportunities, and the cost effectiveness of the requirements.

A state may designate a category of all households residing in a specific area of the state to be exempt. Delaware chooses not to exempt persons based on categories at this time.

B. Individual/Personal Exemptions:

The following kinds of personal characteristics or situations justify exempting an individual otherwise required to participate in the Food Stamp Employment and Training Program.

1. Individuals with such severe deficiencies in employability skills that participation in the Food Stamp Employment and Training Program, as designed and reported here, hold only a very remote probability of achieving the objective of employment or placement in a vocational skills training program;

2. Work registrants requiring child care where it is not available;

3. Reasons of health;

4. Absence of adequate transportation to the training program or to employment locations;

5. Lack of job opportunity;

6. Homeless;

7. Individuals who are in their second or third trimester of pregnancy;

8. Work registrants 55 years of age or older;

9. Employed or self-employed, and working a minimum of 30 hours weekly or receiving weekly earnings at least equal to the Federal minimum wage, multiplied by 30 hours;

10. Participant is in the FSE&T - TANF Program; and

11. Participant is in a substance abuse treatment program and is unable to focus on developing employability skills.

10003.2 Criteria for Authorizing Exemptions

Criteria used to determine whether an exemption should be authorized includes:

A. Individuals with such severe deficiencies in employability skills that participation in the Food Stamp Employment and Training program holds only a remote probability of employment or placement in a vocational skills training program.

B. Individuals determined during either intake screening or assessment to read or compute below the third grade level.

C. Individuals determined during either intake screening or assessment to have severe deficiencies in spoken English language (and live in an area remote from available ESL programs).

D. Work registrants requiring child care where it is not available or child care is not available via public transportation within a reasonable commuting distance. The cost of private transportation is prohibitive.

E. Reasons of Health: After work registering and prior to screening, the participant becomes incapacitated. Temporary personal exemptions from Food Stamp Employment and Training participation may be granted upon recommendation of a physician or a Division of Vocational Rehabilitation enrollment. A temporary medical exemption is approved if the reason for the exemption is expected to last 60 days or more.

F. Absence of adequate transportation to the training program or to employment locations: Work registrant resides in a location not accessible to the Program by public transportation within a reasonable commuting time.

G. Lack of Job opportunity: If State Employment Service information indicates that there are essentially no jobs available within reasonable distance of the participant's residence.

H. Homeless: Participants who do not have adequate shelter or a permanent domicile. DSS assures that this exemption will be granted on a case-by-case basis, where it is not practical to service a particular individual.

I. Individuals who are in their second or third trimester of pregnancy: Persons who have begun their fourth month of pregnancy. The probability of work registrants in their second or third trimester of pregnancy obtaining employment or entering and completing training leading to employment is remote.

J. Work registrants 55 years of age or older: Individuals 55 years of age or older with no formal skills training, have been employed in any capacity in the last 10 years, and have less than a 10th grade education. Chances of success with this participant population is slight. This exemption will ensure the best possible use of limited staff time and resources.

K. Individuals who are employed or self-employed, and working a minimum of 30 hours weekly or receiving weekly earnings at least equal to the Federal minimum wage multiplied by 30 hours: employment prevents individual from participating in employment and training activities.

L. Participant is in the FSE&T - TANF Program: Individual is participating in employment and training activities for TANF recipients.

M. Participant is in a substance abuse treatment program: Individuals receiving substance abuse treatment services who are unable to focus on developing employability skills. Consultation between Case Manager and Substance Abuse Treatment Worker will determine the appropriateness of utilizing this exemption.

Authority to grant individual exemptions rests with the Case Manager, with close monitoring of such exemptions by the Case Manager Supervisor. Final authority rests with the DSS FS E&T Administrator.

Re-evaluate an individual's exemption status at the time of each recertification as per Section 273.7 (f) (2) of the regulations.

**History**
- *23 DE Reg. 873 (04/01/20)*
- *23 DE Reg. 873 (04/01/20)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *10 DE Reg. 1708 (05/01/07)*

##### **16 Del. Admin. Code § 10000-10004** Program Operation {#sec-10000-10004 omnilex-key=us-de-regs-official--title-16--10000-10004}

In the following sections the procedures and policies for operation of the Food Stamp Employment and Training program are discussed, including Referral for the Food Stamps Program to the Food Stamp Employment and Training Program, Good Cause, Sanction Period and Penalty, Information Coordination, Coordination Timeframes, and Inter-Agency Coordination.

10004.1 Referral From Food Stamp Program to Food Stamp Employment and Training Program

As part of their regular intake responsibilities, financial services staff also screen each Food Stamp applicant for work registration requirements. Those registrants determined appropriate for work are referred immediately upon their certification for Food Stamps.

This avoids unnecessary effort on applicants who are deemed ineligible. All Food Stamp Employment and Training referrals take place within 30 days of certification and are derived from the certification and recertification process.

A. Setting Food Stamp Employment and Training Appointment:

When applicants who are determined appropriate for work are certified for Food Stamps, they are referred to Food Stamp Employment and Training. When Food Stamp Employment and Training Case Managers receive the work registrant referral, they immediately send the registrant an appointment letter for an interview. A detailed instruction sheet is also included with this appointment letter that informs each registrant about the program, the registrant's requirements under the program, of their rights and responsibilities, and of the consequences for failing to comply with work requirements. The appointment letter also includes instructions for each registrant to begin an Independent Job Search component, a job search log, and instructions for completing the log.

B. Assessment Interview:

At the interview, work registrants are assessed for their employment and training needs. Case Managers review and audit the Independent Job Search logs and determine whether it is appropriate and necessary for the registrant to continue job search. Based upon the assessment of the Independent Job Search component, a determination is made as to whether the registrant needs further intensive assessment or placement in a basic skills component. For example, if a registrant has difficulty completing a job application, the registrant may be referred to a basic adult education component. Finally, registrants are informed of the requirements of the components, what is needed to comply with the component, and what happens if the registrant fails to comply.

C. Monitoring Compliance:

Case Managers are responsible for monitoring registrant compliance with component requirements. For Independent Job Search, the Case Manager uses the job search log to note the number of job contacts and to make random calls to employers to verify actual job attempts. For other Food Stamp Employment and Training service providers, Case Managers use Food Stamp Employment and Training Weekly Enrollment Status Reports to check registrant compliance.

The weekly enrollment report provides information about registrants who either failed to appear for their initial provider appointment or who failed to meet and maintain service provider participation criteria. Food Stamp Employment and Training Service providers notify Case Managers of registrant non-compliance, using the weekly enrollment reports, within five working days of the date that such information becomes known to the provider. Service providers who do not adhere to the registrant non-compliance requirements have their contracts reduced by an amount equal to vendor cost per registrant times the number of participants not reporting, or not reporting within the required times frames.

10004.2 Good Cause

Case Managers are responsible for determining good cause. If registrants fail to keep either their initial interview with their Case Manager or their service provider requirements, the Case Managers contact registrants to determine if they had good reason for doing so. Good cause includes circumstances beyond the registrant's control, such as, but not limited to:

A. illness,

B. illness of another household member requiring the presence of the member,

C. a household emergency,

D. the unavailability of transportation, or

E. lack of adequate child care for children who have reached age six but are under age 12.

10004.3 Sanction Period and Penalty – See Section 9021 of Food Stamp Policy for appropriate sanctions and penalties

10004.4. Information Coordination

A. Registration in DCIS:

Non-exempt Food Stamp recipients are registered for work at the time of application. The financial services eligibility worker completes the work registration indicator on the Delaware Client Information System (DCIS) input document for each registrant, utilizing a verification indicator.

B. Case Manager Assignment:

The registration indicator on the input document to DCIS produces an automatic referral to the Food Stamp Employment and Training Program, which informs the Case Manager of a work registration referral. Work registrants are assigned to Case Managers, based on the registrant's address.

C. Referral to Components and Service Providers:

Case Managers assign those registrants who keep their assessment interview to an employment and training component, or they determine that the registrant is individually exempt. Case Managers can assign registrants to a continuation of the Independent Job Search component or a component provided by WIA or a contracted service provider.

Case Managers use the E & T MIS to refer registrants to contracted service provider programs. Case Managers also make a hard copy of the referral and send it to the contracted service provider. Case Managers also make referrals to WIA programs.

Contracted service providers use the weekly enrollment status report to notify Case Managers of any registrant concerns. This report informs Case Managers of registrants who fail to keep their initial contractor appointment or who fail to meet and maintain contractor criteria.

D. Change in Exemption Status:

It is the responsibility of the service providers to notify Case Managers of any circumstances which may cause registrants to fall into exempt categories. This is particularly important where the situation of the registrant has changed since assignment to the component. The Case Managers review this information and determine if the participant is exempt. In turn, Case Managers notify service providers of significant interim changes, such as address, participation status, and so forth.

10004.5 Coordination Time Frames

Time frames for the most part have been discussed previously. However to repeat in summary form: the time from the recipient application for Food Stamps, and the determination of eligibility by a financial services worker, to referral into the Food Stamp Employment and Training Program, should be immediate. In no event does the time frame take more than 30 days.

10004.6 Inter-Agency Coordination

The Division jointly administers its Food Stamp Employment and Training Program with its FS E&T - TANF program. Food Stamp Employment and Training activities are fully coordinated with parallel FSE&T - TANF activities. The Division may utilize the services of providers already serving FSE&T - TANF participants, FS E&T - TANF and Food Stamp Employment and Training participants, or not serving our population at all.

Other than its Independent Job Search component, the Division does not directly deliver services in a component. Primarily, either non-financial inter-agency agreements or contracted services through community based programs are used to provide component services to registrants. Inter-agency agreements exist with the Delaware Private Industry Council, the Department of Labor and the Department of Education.

Referral mechanisms exist with WIA funded and other training programs. For the most part, registrants who are appropriate for these programs are referred through contractor arrangement. Wherever this occurs, the contractor is asked to monitor registrant participation and report information to Case Managers.

The Division, however, has increased its use of WIA funded programs and has therefore, increased the number of such referrals directly from Case Managers. The process used by Food Stamp Employment and Training Case Managers to make WIA referrals is the same process currently in use by our FSE&T - TANF Case Managers.

10004.6.1 Methods of Coordination

As noted above, non-financial inter-agency agreements are maintained with other State agencies to provide component services. In addition, the Division has financial contracts with a number of community based organizations to also provide component services. The Division is also committed to working closely with agencies that provide employment and training help to registrants. In this regard, Division representatives meet regularly with Private Industry Council staff members, the Division coordinates its employment and training plans with existing State resources, and makes use of informal referral mechanisms wherever appropriate.

**History**
- *23 DE Reg. 873 (04/01/20)*
- *23 DE Reg. 873 (04/01/20)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *10 DE Reg. 1708 (05/01/07)*

##### **16 Del. Admin. Code § 10000-10005** Justification of Educational Costs {#sec-10000-10005 omnilex-key=us-de-regs-official--title-16--10000-10005}

Delaware's Food Stamp Employment and Training Program does not supplant education costs from the State to the Federal government.

Education offered under the Food Stamp Employment and Training program is not traditional basic or remedial education, but is uniquely tailored to job entry by low vocational skilled, low literacy, or low computational skilled individuals. Similar services are provided to FS E&T - TANF participants.

The Division's experience of contracts with community-based agencies has demonstrated that individuals with severe academic deficiencies can improve practical educational skills if the approach to basic skill remediation is applied to real life experiences. Teaching in the Food Stamp Employment and Training Program differs substantially from the Adult Basic Education (ABE) and GED classes funded by the Delaware Department of Education in that:

A. instruction is year round, rather than only during the school year, and

B. the majority of classes take place during the day when most work registrants prefer to attend because their children are in school during this time.

Programs offered have measurable objectives related to participant achievement, and individual education plans are developed for each student. Delaware Department of Education classes leave this area to the discretion of the individual teacher.

The goal of this education is placement in employment or training leading to employment. Public instruction classes do not have this as their primary goal.

This program is linked to other critical job related components such as life skills, counseling, orientation to the world of work, and other support services. The Department of Education classes do not have this employment direct coordination.

**History**
- *23 DE Reg. 873 (04/01/20)*
- *23 DE Reg. 873 (04/01/20)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *10 DE Reg. 1708 (05/01/07)*

##### **16 Del. Admin. Code § 10000-10006** Contractual Arrangements {#sec-10000-10006 omnilex-key=us-de-regs-official--title-16--10000-10006}

Delaware contracts out the operation of the Basic Life Skills Component and the Self-Directed Job Search Component of the Food Stamp Employment and Training Program to community based agencies who are selected through a competitive procurement process. Under the direct supervision of the DSS Food Stamp Chief Administrator, the same procedures established for the monitoring and management of TANF participants and programs is implemented for Food Stamp Employment and Training participants, except that separate budgets and program records are maintained for the two participant populations. Contractors, in accordance with their contract, are reimbursed for actual costs associated with providing services.

The following information is maintained:

A. the name and location of the contractor;

B. the amount of the contract;

C. the contract management approach that will be followed; such as performance based contract;

D. the basis for charging for contractual services; for example, will the actual costs be claimed or a certain amount per activity;

E. the number of persons expected to be placed through the contract;

F. whether the contract was competitively awarded or sole source; for example, not bid, but negotiated; and

G. the method for monitoring the performance of the contractor, and the results of such monitoring.

**History**
- *23 DE Reg. 873 (04/01/20)*
- *23 DE Reg. 873 (04/01/20)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *10 DE Reg. 1708 (05/01/07)*

##### **16 Del. Admin. Code § 10000-10007** E & T Non ABAWD Participant Reimbursement {#sec-10000-10007 omnilex-key=us-de-regs-official--title-16--10000-10007}

Participants are reimbursed for necessary expenses incurred while fulfilling Food Stamp Employment and Training requirements or obtaining/maintaining employment. Reimbursements are available in the following areas:

A. Transportation as defined in 10007.1.

B. Dependent care expenses as defined in 10007.2.

C. Support Services as defined in 10007.3.

Transportation, Dependent Care and Supportive Services payments are for all E & T mandatory or voluntary Non ABAWD participants.

10007.1 Method of Reimbursement for Transportation

The State agency elects to reimburse participants for transportation based on an initial allowance plus actual verified expenses incurred beyond the initial allowance.

The total cost per participant per month is a reimbursement amount equal to the initial allowance plus actual costs documented by the participant that are above the initial allowance, but not exceeding the standard amount of $30.00.

Upon successful completion of the IJS log the participant will automatically receive a system generated transportation allowance. The allowance is $5.00 for New Castle County (NCC) and $10.00 for Kent and Sussex (K/S).

Upon computer verified participation at a DOL One Stop Service Center the participant will automatically receive a system generated transportation allowance. The allowance is $5.00 for NCC and $10.00 for K/S.

Participants can receive only one transportation allowance check per month to attend the One Stop Service Center regardless of the number of times they go to the One Stop Service Center. Participants can only receive one transportation allowance check per month. If the participant completes an IJS log and goes to the One Stop Service Center in the same month they will only receive one allowance check.

A participant may be reimbursed additional monies if the participant brings in verification of the actual expenses that were above the initial $5.00 or $10.00 allowance. The total monthly reimbursement should not exceed $30.00.

Any monthly total exceeding $30.00 must be verified and approved by a supervisor.

10007.2 Dependent Care Reimbursement

Dependent Care reimbursement can be authorized when a Food Stamp Employment and Training participant needs dependent care to participate in an E&T component or employment

Dependent Care expenses are determined by the approved Purchase of Care program fee scale.

DSS provides dependent care services through licensed and exempt facilities. The types of care provided include: full-time care, before/after school care, and extended child care in either a family/group home or child care center.

Offer the participant an option of using a child care facility with a contract with DSS or any other licensed or exempt facility a registrant might choose. Monthly Child care providers submit monthly attendance reports to the Division of Management Services, Payment Section. The Payment Section enters the attendance data in the Child Care Management Information System which makes payment to providers based on attendance and the prescribed Food Stamp Employment and Training dependent care formula.

Dependent Care can be authorized to a voluntary participant.

Example:

An 18 year old High School graduate with a 3 year old child can volunteer for the E&T program and receive child care for either work hours or school hours.

10007.3 Supportive Services Reimbursements

All Supportive Services reimbursements/payments must be actual costs that are necessary for Employment and Training participation. They must be verified and documented. Services to obtain and keep employment are not an allowable reimbursement.

Supportive Services reimbursements /payments can be provided under the following categories;

A. Fees

These services can include testing for employment or education (this includes GED test fees), or other fees directly related to training.

Monetary Limit of Service / Expense: Verified actual cost up to $200.00 per individual, per month as determined by need.

B. Clothing

These services can include only clothes that are appropriate for interviewing prior to a job offer.

Monetary Limit of Service / Expense: Verified actual cost up to $150.00 per individual. This is a one time only service.

C. Accessories for Training

These services can include purchase of safety equipment, uniforms, shoes, or tools required to participate in training. The need in some cases can be verified by Office of Safety and Health Administration (OSHA) regulations.

Monetary Limit of Service / Expense: Verified actual cost up to $150.00 per individual, per month as determined by need.

D. Physical Exam

This service can be authorized when a participant is required to undergo a physical exam to participate in training and such exam is not available through a public health facility or covered by Medicaid.

Monetary Limit of Service / Expense: Verified actual cost up to $100.00 per individual, per month as determined by need.

E. Eye exams and eyeglasses

When the assessment indicates the participant’s vision is impaired, or when the individual needs glasses to continue in a component. This does not include contact lenses unless they are medically necessary.

Monetary Limit of Service / Expense: Verified actual cost up to $200.00 per individual, per month as determined by need.

**History**
- *23 DE Reg. 873 (04/01/20)*
- *23 DE Reg. 873 (04/01/20)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *10 DE Reg. 1708 (05/01/07)*

##### **16 Del. Admin. Code § 10000-10008** Program Reporting and Management Information {#sec-10000-10008 omnilex-key=us-de-regs-official--title-16--10000-10008}

Program reporting and management information includes ensuring there is an unduplicated work registrant count and meeting federal reporting requirements.

A. Method of Ensuring an Unduplicated Work Registrant Count

On the last day of each month, the E & T MIS reviews all work registrant transaction summaries to determine referrals from eligibility staff. The E & T MIS produces a count of newly referred work registrants (work registrants not counted in previous months of the federal fiscal year). Additionally, the E & T MIS places a federal fiscal year indicator on each of these work registrants to prevent that individual from being counted again during the current federal fiscal year.

B. Methods for Meeting On-Going Federal Reporting Requirements

1. Management Information System (MIS):

Delaware produces its reports from the aggregate hard copy reports produced by DCIS, E & T MIS, manual reports from Food Stamp Employment and Training staff, and manual reports from community based providers.

2. Local Reporting Requirement:

Contractors, Food Stamp Employment and Training staff, and our automated systems produce regular reports. Food Stamp Employment and Training staff report the number of work registrants entering a component and the number and reasons for individual exemptions. Community based providers report on the names of work registrants entering a component, and the names of work registrants failing to comply with program requirements (for example, not coming to a scheduled interview, not attending class). Local agencies and contractors report weekly.

**History**
- *23 DE Reg. 873 (04/01/20)*
- *23 DE Reg. 873 (04/01/20)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *8 DE Reg. 1618 (5/01/05)*
- *10 DE Reg. 1708 (05/01/07)*

#### **13000** Medical Assistance Program Overview

##### **16 Del. Admin. Code § 13000-13100** History Of Medicaid {#sec-13000-13100 omnilex-key=us-de-regs-official--title-16--13000-13100}

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13110** National Perspective {#sec-13000-13110 omnilex-key=us-de-regs-official--title-16--13000-13110}

In 1933, the Federal Relief Administration made funds available to states to pay for the medical expenses of the unemployed in need of medical care. When the Social Security Act was passed in 1935, it did not include any dollars specifically targeted for medical care. By the end of the 1930's, the Social Security Act had been amended to provide federal funds for medical care to specific segment of the population such as maternal and child health and aid to the aged.

The Social Security Act was amended in 1965 to include Medicare and Medicaid. The Medicaid program was created by Title XIX of the Social Security Act "for the purpose of enabling each State to furnish medical assistance on behalf of families with dependent children and of aged, blind or individuals with a disability whose income and resources are insufficient to meet the cost of necessary medical services...".

At its inception, the Medicaid program defined eligible groups and services that were mandated for coverage in order to receive any Federal funding. In addition, individual States could elect to cover a limited number of optional groups and services for which they would receive a federal match on State dollars. With the passage of years, the Federal government has expanded the pool of mandatory and optional groups and services for Medicaid coverage.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13200** Other Titles Of The Social Security Act {#sec-13000-13200 omnilex-key=us-de-regs-official--title-16--13000-13200}

Other titles of the Social Security Act have had an impact on Medicaid. These are listed in the following sections.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13210** Title II Federal Retirement, Survivors, And Disability Insurance Benefits {#sec-13000-13210 omnilex-key=us-de-regs-official--title-16--13000-13210}

This is the basis for Social Security benefits.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13220** Title IV Grants To States For Aid and Services To Needy Families With Children and For Child Welfare Services {#sec-13000-13220 omnilex-key=us-de-regs-official--title-16--13000-13220}

This is the basis for TANF and services for some Foster Children.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13230** Title V Maternal and Child Health Services Block Grant {#sec-13000-13230 omnilex-key=us-de-regs-official--title-16--13000-13230}

This provides funding to the Division of Public Health to combat infant mortality and support efforts to care for children.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13240** Title XVI Supplemental Security Income For The Aged, Blind and Disabled - SSI {#sec-13000-13240 omnilex-key=us-de-regs-official--title-16--13000-13240}

This provides financial support for low income individuals.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13250** Title XVIII Health Insurance For The Aged and Disabled {#sec-13000-13250 omnilex-key=us-de-regs-official--title-16--13000-13250}

This forms the foundation for the Medicare program.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13300** Difference Between Medicare And Medicaid {#sec-13000-13300 omnilex-key=us-de-regs-official--title-16--13000-13300}

There are significant differences between Medicaid and Medicare. Both programs were created by the Social Security Act in 1965. Medicaid (Title XIX) is funded by both the Federal government and State that administers the program. Because of options for coverage, the Medicaid program varies widely from State to State. Medicare (Title XVIII) is a Federally funded and administered health insurance program which has uniform rules, regulations, and benefits in every state.

Differences

Medicaid

Medicare

Administration

State

Federal

Funding

50% State/50% Federal with exceptions for a higher Federal match for certain services & staff and a higher match for poorer States

100% Federal

Eligibility

Limited Income & Resources

Age, Disability and Work History

Coverage

Broad range of Services

Part A= inpatient hospital, home health, hospice and post-hospital skilled nursing facility care.

Part B= physicians, labs, clinics, physical therapists, extended home health & limited out-patient hospital services.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13310** Delaware Medicaid Program Growth {#sec-13000-13310 omnilex-key=us-de-regs-official--title-16--13000-13310}

The Medicaid Program was implemented in Delaware in July, 1967. The following pages chart the growth of the program and identify the groups and services that are covered in Delaware.

Delaware Medical Assistance Program (DMAP) History

DATE

ELIGIBILITY GROUP

MANDATE

OPTION

COVERED SERVICE

MANDATE

OPTION

7/67

AFDC recipients

X

Inpatient Hospital

X

Old Age Assistance (OAA)

X

Outpatient Hospital

X

Aid to the Blind (AB)

X

X-Ray and Laboratory

X

Aid to the Disabled (AD)

X

Skilled Nursing for age 21 +

X

18-21 yr. old AFDC-related

X

Physician Services

X

Foster Children

X

Drugs

X

AFDC < $5 (no grant pymt)

X

Home Health Services

X

Clinic Services

X

Family Planning

X

Podiatry (non-routine)

X

4/70

Inpatient Psychiatric  age 65

X

1/72

Adult Foster Care

X

Transportation

X

7/72

Loss of SSI due to 7/72 COLA

X

EPSDT

X

Optometry for < age 21

X

7/73

Intermediate Care Facilities

X

SSI (replacing OAA, AB, AD)

X

1/74

Mandatory State Supplement

X

Optional State Supplement

X

7/77

Loss of SSI due to SSA COLA

X

9/77

Prospective eligibility (4 Mos.)

X

Long Term Care Bed-Hold Days

X

5/78

Retroactive eligibility (3 Mos.)

X

5/79

GAs under age 21

X

7/79

Skilled nursing for < age 21

X

10/79

AFDC-UP

X

Rural Health Clinic Services

X

6/80

Foster Kids awaiting placement

X

7/80

Patients in medical institutions with incomes less than 180% of SSI standard

X

Aphakic lenses

X

10/80

Apnea Monitors

X

1/81

1619(b) disabled working - loss of SSI

X

Dental / Oral Surgery

X

1/82

Pregnant women in 9th month of pregnancy

X

Nurse Midwifery

X

7/82

ICF/MR (Stockley Center)

X

9/82

IV-E Adoption Assistance

X

1/83

Cases denied AFDC due to step-parent or alien sponsor income deeming

X

4/83

Private Duty Nursing

X

7/83

Home and Community-Based Services Waiver for the Mentally Retarded

X

1/84

AFDC-related pregnant women in the 4th month of pregnancy

X

8/84

Families losing AFDC due to child support (4 additional months of Medicaid.)

X

10/84

Families losing AFDC due to loss of 30 &/or 1/3 income deductions

X

Pregnant women from verification of pregnancy

X

Cases denied AFDC due to grandparent or sibling income deeming

X

Children < age 5 with family income < AFDC standard

X

Infants of Medicaid mothers from date of birth

X

Pickle People (loss of SSI due to any type of SSA increase)

X

7/85

ICF/IMD (Delaware State Hospital)

X

10/85

AFDC < $10 cases (no cash grant)

X

Disabled Widows/Widowers

X

Super Skilled Nursing Pymt Method

X

Pregnant women to 60+ days postpartum

X

1/86

Disabled Children under

42 CFR §435.225

X

7/86

Home and Community-Based Services Waiver for the Elderly and Disabled

X

1/87

State-funded Adoption Assistance children

X

Experimental Organ Transplants

X

7/87

Adult Disabled Children

X

Hospice services

X

Dropped GA's age 18 - 21 by federal mandate

X

Added limited services for aliens

X

12/87

Federal redefinition of nursing facilities (NFs) merge ICF services and SNF services (ICF no longer optional)

X

1/88

Pregnant women and infants under 100% of Federal Poverty Limit (FPL)

X

Extended Pregnancy Services - "Smart Start" Program

X

7/88

Kids < age 2 < 100% of FPL

X

10/88

Private Adoption Agency Kids

X

1/89

Kids < age 3 < 100% of FPL

X

Community Mental Health Support Services (Rehabilitation option)

X

10/89

Long-Term Care eligibility increased from 180% to 200% of SSI standard

X

Prescribed Pediatric Extended Care (PPEC)

X

1/90

Qualified Medicare Beneficiaries (QMBs) *

X

4/90

Pregnant women and infants

< 133% of FPL

X

Federally Qualified Health Centers (FQHCs)

X

Children < age 6 < 133% of FPL

X

Expanded EPSDT requirements including school-based services

X

Certified Nurse Practitioners

X

7/90

Pregnant teens (disregard ½ of parental income)

X

Durable Medical Equipment and Supplies (DME)

X

Qualified Disabled Working Individuals (QDWIs)

X

Enteral & Parenteral supplements & supplies in limited circumstances

X

1/91

Long-Term Care eligibility increased from 200% to 210% of SSI standard

X

Home and Community-Based Services Waiver for AIDS and HIV+ patients

X

4/91

Pregnant women and infants

< 160% of the FPL

X

Children < age 8 < 100% of FPL

X

10/91

Children < age 9 < 100% of FPL (born after 9/30/83)

X

1/92

Mental Health Clinics

X

4/92

Personal Care services for mental health Community Support Clients

X

10/92

Children < age 19 < 100% of FPL (born on or after 10/1/74)

X

Day Health and Rehabilitation services for the Mentally Retarded and Developmentally Delayed

X

Pregnant women and infants

< 185% of FPL

X

1/93

Specified Low Income Medicare Beneficiaries (SLIMBs) *

X

7/1/93

DMAP assumed responsibility for the operation of the State funded Chronic Renal Care program which provides limited coverage to non-Medicaid eligibles or for non-Medicaid services

N/A

N/A

Services provided under the Chronic Renal program include transportation to and from dialysis and some pharmaceuticals and over-the-counter drugs

N/A

N/A

10/93

Long-Term Care eligibility increased from 210% to 230% of SSI standard

X

10/94

Long-Term Care eligibility increased from 230% to 250% of SSI standard

X

1/1/95

SLIMB eligibility increased to 120% of FPL

X

3/1/95

Individuals suspended or terminated from SSI due to drug and/or alcohol program limitations (group deleted 1/1/97)

X

10/1/95

GAHF clients become regular Medicaid

X

(Demo-

waiver)

Post-partum coverage extended from 60 days to 90 days

X

(Demo-

waiver)

10/1/95

As part of the State’s Welfare Reform waiver, Delaware’s A Better ChanceWelfare Reform Program (TANF), transitional Medicaid was extended up to 24 months after loss of cash benefits.

X

(Demo-

waiver)

1/1/96

Implementation of managed care for all clients except long-term care recipients (nursing home and home and community-based waiver clients), dual Medicare/Medicaid eligibles, and individuals with accessible managed care health insurance from another source

X

(Demo-

waiver)

As part of the Diamond State Health Plan managed care waiver, family planning services will continue for women for 24 months beyond the month that they are terminated from a Medicaid eligibility group for non-fraudulent reasons

X

(Demo-

waiver)

3/1/96

Adults with incomes less than or equal to the Federal Poverty Level who have no other health insurance coverage once a managed care plan is chosen - no resource test

X

(Demo-

waiver)

1/1/97

The Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (PRWORA) replace the AFDC program with the TANF (Temporary Assistance for Needy Families) program and uncoupled the automatic link to Medicaid eligibility for individuals who receive financial assistance. Delaware opted to maintain the same eligibility groups for Medicaid.

X

1/1/97

PRWORA limited eligibility for non-citizens

X

PRWORA limited services for non-citizens

X

7/1/97

The Balance Budget Act of 1997 protects Medicaid eligibility for children who lost SSI because of PRWORA changes which redefined disability for SSI.

X

Medicaid will pay Medicare Part B premiums for QI=1s and the small portion of Part B premium for QI-2s that was transferred from Part A.

X

4/1/98

The Balanced Budget Act of 1997 added a new group of Medicare qualifying individuals who have income between 120% and 135% of FPL (QI-1) and another group who have income between 135% and 175% of the FPL (QI-2).

X

Medicaid will pay Medicare Part B premiums for the QI-1s and the small portion of the Part B premium for QI-2s that was transferred from Part A

X

10/1/98

Home and Community-Based Services, waiver for Assisted-Living

X

1/1/99

Delaware Healthy Children Program (See Chart on page 22)

X

See Chart on page 22.

X

1/1/99

Made changes to the Diamond State Health Plan (DSHP) to include clients with other accessible managed care.

X

Included all private duty nursing hours PPEC services, and PDDN services in basic DSHP MCO benefit.

X

6/1/99

Section 1931 - Eliminate resource test exclude interest/dividend income, recipient income test for applicants, disregard 2nd and 3rd month of earned income.

X

10/1/99

Add coverage of adoption subsidy children coming from other states.

X

12/1/99

Implement six (6) month guaranteed eligibility for managed care enrollees under The Balanced Budget Act of 1997.

X

1/14/2000

The Delaware Prescription Assistance Program is a State funded program for individuals 65 or over or under 65 and receiving Social Security Disability with income less than 200% FPL and prescription drug expenses that exceed 40%of income.

N/A

Medically necessary prescriptions provided by manufacturers who agree to participate in the State Rebate Program. Limited to $2500.00 per fiscal year.

N/A

5/1/2000

Eliminate resource test and disregard interest/dividend for QMBs, SLMB, QI's and QDWI.

X

7/2000

DSHP MCO will cover only 28 hours of private duty nursing services per week.

X

11/1/2000

Pregnant women and infants increased to 200% FPL.

X

3/1/2001

Add optional State supplement for individuals who lose SSI due to receipt of Social Security Disability and who do not have Medicare.

X

1/1/2002

Add uninsured women under age 65 who need treatment for breast or cervical cancer.

X

6/1/2002

Eliminate six (6) month guaranteed eligibility for managed care enrollees.

X

1/1/2003

Group of Medicare qualifying individuals with income between 135% and 175% FPL sunsets.

X

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13320** Medicaid Funding {#sec-13000-13320 omnilex-key=us-de-regs-official--title-16--13000-13320}

The Medicaid program is funded by both State and Federal dollars. The Federal Government contributes 50% of the total Medicaid dollars, but for some services a higher federal match is contributed. Family planning services, for instance, are funded with 90% Federal dollars and the salaries of some Medicaid nursing staff who have direct patient medical contact are funded with 75% Federal dollars. To receive Federal Financial Participation (FFP), the program must comply with rules that are issued by the Federal Department of Health and Human services (DHSS) as Title 42 of the Code of Federal Regulations (42CFR), Chapter IV, Subchapter C.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13330** Administration Of Medicaid In Delaware {#sec-13000-13330 omnilex-key=us-de-regs-official--title-16--13000-13330}

The Department of Health and Social Services (DHSS) is designated as the single agency in Delaware responsible for the overall administration of the Medicaid program. This administrative responsibility is discharged at the operational level through the various units in the Division of Social Services.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13400** Eligibility For Medicaid {#sec-13000-13400 omnilex-key=us-de-regs-official--title-16--13000-13400}

Medicaid eligibility is acknowledged to be the most intricate piece of a very complex program. Designed in 1965 as a medical program for persons on existing welfare programs, the Medicaid Program originally served those eligible for Aid to Families with Dependent Children (AFDC) or for the programs now encompassed by the Supplemental Security Income (SSI) program.

Since 1965, there have been many additional groups of eligibles added to the Medicaid Program.

For local eligibility workers, assuring that a client's eligibility is appropriately determined can present a challenge. As eligibility errors can result in substantial financial penalties, workers must carefully determine eligibility.

The following subsections in 13400 give a brief synopsis of the various eligibility groups. Refer to specific sections for eligibility requirements.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13401** AFDC/TANF-Related Groups {#sec-13000-13401 omnilex-key=us-de-regs-official--title-16--13000-13401}

In the past, Medicaid eligibility for the majority of the populations was categorically linked to either the Aid to Families with Dependent Children (AFDC) program or the Supplemental Security Income (SSI) program. Throughout the years, the federal government gave states more and more options to cover groups that may have had a technical tie to the cash assistance eligibility groups, but with income and resources above those eligibility limits. With passage of the Personal Responsibility and Work Opportunity Reconciliation Act (PRWORA) of 1996, the AFDC program was dissolved and, along with it, the automatic link to Medicaid for recipients of cash assistance. The PRWORA replaces AFDC with block grants to states for Temporary Assistance to Needy Families (TANF). The PRWORA also requires that state Medicaid programs maintain some relationship to groups eligible at the time of passage of this act, but gave the Medicaid program more flexibility in determining eligibility for services.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13402** Delaware's Temporary Assistance to Needy Families Program {#sec-13000-13402 omnilex-key=us-de-regs-official--title-16--13000-13402}

Before the passage of PRWORA, anyone receiving cash assistance under AFDC was automatically entitled to Medicaid. Under the new law, persons receiving assistance under the block grant (TANF) are not automatically entitled to Medicaid. A new Medicaid eligibility group for low income families with children was established at Section 1931 of the Social Security Act added by section 114 of PRWORA.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13404** Low Income Families With Children Under Section 1931 {#sec-13000-13404 omnilex-key=us-de-regs-official--title-16--13000-13404}

The Personal Responsibility and Work Opportunity Reconciliation Act of 1996, P.L. 104-193, Section 114, established a new Medicaid eligibility group for low income families with children at Section 1931 of the Social Security Act. Coverage for this mandatory categorically needy group of families with children was effective March 10, 1997, the date that Delaware's TANF plan was approved.

Families who are eligible for Medicaid under Section 1931 may be receiving TANF cash assistance or may be Medicaid only families.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13405** Pregnant Women And Infants {#sec-13000-13405 omnilex-key=us-de-regs-official--title-16--13000-13405}

Statutory Authority

42 CFR 435.116

42 CFR 435.170

A pregnant woman who is found to be eligible for Medicaid and receives services during her pregnancy will continue to be eligible for Medicaid from verification of her pregnancy until at least 12 months after the pregnancy ends. Eligibility will be a continuous 12 month period after the pregnancy ends unless one the of the following applies:

Infants born to Medicaid eligible mothers are deemed eligible for Medicaid for one year as long as the mother remains eligible and the child remains in the house with the mother.

See 15200.6 Postpartum Period

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13406** "Ribicoff" Children {#sec-13000-13406 omnilex-key=us-de-regs-official--title-16--13000-13406}

The Deficit Reduction Act of 1984 (DEFRA) mandated Medicaid coverage to children born on or after 10/1/83, who are under age 5, and who meet AFDC income and resource requirements, but not the characteristics of a "dependent" child. Section 1905(n) of the Social Security Act was subsequently amended to mandate a phase-in of all such qualified children up to age 19.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13407** Income Deeming Eligibles {#sec-13000-13407 omnilex-key=us-de-regs-official--title-16--13000-13407}

When income deemed from a step-parent, grandparent, or sibling makes an individual ineligible for benefits, Medicaid determines eligibility excluding that deemed income.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13408** Institutionalized Individuals {#sec-13000-13408 omnilex-key=us-de-regs-official--title-16--13000-13408}

Individuals who would be eligible for AFDC if not in a medical institution or nursing facility are eligible for Medicaid under Delaware’s Plan.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13409** Transitional Medicaid/Prospective (Child Support Extension) {#sec-13000-13409 omnilex-key=us-de-regs-official--title-16--13000-13409}

Prior to PRWORA, a family’s eligibility for Transitional or Prospective Medicaid was linked to receipt of AFDC. Under PRWORA, a family’s eligibility for transitional Medicaid is linked to receipt of Medicaid under “Low Income Families with Children under Section 1931.

Families who lose Medicaid under Section 1931 because of earnings or loss of earned income disregards, may be eligible for up to 12 months of extended Medicaid coverage. Families who lose Medicaid because of new or increased child or spousal support, may be eligible for up to 4 months of extended Medicaid coverage.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13410** IV-E Foster Children And Adoption Assistance Children {#sec-13000-13410 omnilex-key=us-de-regs-official--title-16--13000-13410}

Children whose families, sponsors or foster parents receive benefits under Title IV-E of the Social Security Act are eligible for Medicaid benefits.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13411** Foster Children {#sec-13000-13411 omnilex-key=us-de-regs-official--title-16--13000-13411}

Foster children and children in private facilities for whom a public agency is assuming full or partial financial responsibility would be in this optional category.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13412** Children In Custody {#sec-13000-13412 omnilex-key=us-de-regs-official--title-16--13000-13412}

Children for whom any Division within DSCYF has custody or consent to place and who have been removed from their own home, and are in a medical facility for a temporary planning period prior to placement would fall in this optional coverage category.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13413** State Funded Adoption Assistance Children {#sec-13000-13413 omnilex-key=us-de-regs-official--title-16--13000-13413}

State Funded Adoption Assistance Children with some special needs do not meet the technical requirements for funding under the Title IV-E program, but their adoptive parents need financial assistance to meet the medical needs of the child. The State provides funding to assist the adoptive family.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13414** General Assistance {#sec-13000-13414 omnilex-key=us-de-regs-official--title-16--13000-13414}

RESERVED

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13430** SSI-Related Groups {#sec-13000-13430 omnilex-key=us-de-regs-official--title-16--13000-13430}

These are individuals who are categorically related to the SSI Program.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13431** SSI Recipients {#sec-13000-13431 omnilex-key=us-de-regs-official--title-16--13000-13431}

Any individual aged 65 years or over, blind, or permanently disabled (i.e. unable to engage in substantial gainful activity), receiving a benefit through the Supplemental Security Income program, is automatically eligible for Medicaid in Delaware.

Because Delaware covers all SSI beneficiaries, it is known as a “1634 state." Other states, commonly referred to as “209-b states," have more restrictive criteria for eligibility than the SSI program.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13432** Individuals Who Would Be SSI Recipients Except For The July, 1972 Increase In Old-Age, Survivors, and Disability Insurance (OASDI) Benefits {#sec-13000-13432 omnilex-key=us-de-regs-official--title-16--13000-13432}

These are individuals who were receiving OASDI and would be a SSI recipient now if the July 1972 increase in OASDI were deducted from the individual’s income.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13433** Recipients Of Mandatory State Supplementary Payments {#sec-13000-13433 omnilex-key=us-de-regs-official--title-16--13000-13433}

When the Federal SSI program was implemented in 1974, states were mandated to provide supplemental payments to individuals aged, blind or disabled who would get less money under SSI than they got under the Old Age Assistance (OAA), Aid to the Blind (AB), and Aid to the Disabled (AD) programs formerly administered by the states. Delaware still has a few individuals who get mandatory state payments and they are eligible for Medicaid.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13434** Recipients Of Optional State Supplement Payments {#sec-13000-13434 omnilex-key=us-de-regs-official--title-16--13000-13434}

Delaware provides a state supplement payment (SSP) to elderly and disabled SSI recipients in adult residential care arrangements and certain individuals in assisted living facilities. The amount of payment generally relates to the level of assistance provided in the living arrangement. These individuals qualify for Medicaid.

An optional state supplement of $5.00 is provided to individuals who lose SSI because of the receipt of Social Security Disability and are not yet eligible for Medicare.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13435** Pickle Amendment - Loss Of SSI Due To SSA Increases {#sec-13000-13435 omnilex-key=us-de-regs-official--title-16--13000-13435}

Individuals who lose their SSI due to an increase in Social Security benefits are referred to as “Public Laws or “Pickle People. They continue to be eligible for Medicaid as long as their combined income and resources, disregarding all SSA increases since they lost SSI, does not exceed the current SSI standard.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13436** 1619(B) Eligibles {#sec-13000-13436 omnilex-key=us-de-regs-official--title-16--13000-13436}

Prior to 1981, some individuals with severe disabilities lost SSI and Medicaid due to employment. The loss of Medicaid often meant that the individuals could no longer afford their medical care and were forced to quit their jobs and go back on SSI to assure Medicaid coverage. An amendment to the Social Security Act, Section 1619(b) was passed to allow these individuals to retain their Medicaid coverage while they continued working. These clients are referred to as “1619(b)s.” The Social Security Administration determines eligibility for this group.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13437** Widows/Widowers (Age 60-64) {#sec-13000-13437 omnilex-key=us-de-regs-official--title-16--13000-13437}

Individuals eligible under this category are over age sixty and under age 65. They lost SSI due to income drawn from a deceased spouse’s SSA account. Medicaid coverage continues until individuals become eligible for Part A Medicare when they reach age 65. They must meet SSI income and resource limits. The widow/widower benefit is disregarded.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13438** Widows/Widowers with Disabilities (Age 50-59) {#sec-13000-13438 omnilex-key=us-de-regs-official--title-16--13000-13438}

These are certain widow(er)s with disabilities who lose SSI/SSP because they began receiving Title II Social Security disabled widows benefits. They are deemed to be SSI recipients for Medicaid purposes until they are entitled to Medicare. They must meet SSI income and resource limits. The widow/widower benefit is disregarded.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13439** Adult Children with Disabilities {#sec-13000-13439 omnilex-key=us-de-regs-official--title-16--13000-13439}

Individuals eligible under this category are over age 18 and became disabled before the age of 22. They lost SSI due to income drawn from the SSA account of an aged, blind disabled or deceased parent.

Eligibility is the same as for SSI except that the SSA benefit is disregarded for Medicaid eligibility.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13441** Children with Disabilities {#sec-13000-13441 omnilex-key=us-de-regs-official--title-16--13000-13441}

Children with disabilities under age 19 who require an institutional level of care, but can be cared for cost-effectively at home, may be covered.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13442** Institutionalized Individuals {#sec-13000-13442 omnilex-key=us-de-regs-official--title-16--13000-13442}

Institutionalized individuals may qualify for Medicaid based upon a higher income standard than that used for SSI individuals. States are allowed to use an income standard that is as much as 300% of the SSI uniform payment.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13443** Home and Community Based Waivers {#sec-13000-13443 omnilex-key=us-de-regs-official--title-16--13000-13443}

States may request “waivers of federal Medicaid requirements to provide needed medical and support services to people who need an institutional level of care but who can, with those additional services, remain in their own homes. Delaware currently has approved waivers. The waivers include:

Elderly and Disabled Waiver;

Developmental Disabilities and Mental Retardation Waiver;

AIDS/HIV Waiver;

Assisted Living Waiver.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13444** Qualified Medicare Beneficiaries (QMB) {#sec-13000-13444 omnilex-key=us-de-regs-official--title-16--13000-13444}

Effective January 1990, Delaware began to pay Medicare premiums, co-insurance, and deductible amounts for Medicare beneficiaries with income that does not exceed 100% of poverty.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13445** Specified Low Income Medicare Beneficiaries (SLIMB) {#sec-13000-13445 omnilex-key=us-de-regs-official--title-16--13000-13445}

Beginning January 1, 1993, Medicaid will pay the Medicare Part B premium for these individuals who have income that does not exceed 120% of poverty. They do not receive any Medicaid services.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13446** Qualified Disabled And Working Individuals (QDWI) {#sec-13000-13446 omnilex-key=us-de-regs-official--title-16--13000-13446}

These are disabled individuals who lose premium-free part A Medicare benefits due to employment. Medicaid will pay the Part A premiums for these individuals who have income at or below 200% FPL.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13447** Qualifying Individuals {#sec-13000-13447 omnilex-key=us-de-regs-official--title-16--13000-13447}

Two mandatory eligibility groups of low income Medicare beneficiaries were established by the Balanced Budget Act of 1997. The first group (QI-1s) have income between 120% and 135% of FPL and are eligible to have their Part B premiums paid by Medicaid. The second group (QI-2s) have income between 135% and 175% of FPL and receive a direct payment from Medicaid for the small portion of Part B premium that was transferred from Part A. The QI-2 was not reauthorized by Congress and terminated December 31, 2002.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13460** Poverty Level Groups {#sec-13000-13460 omnilex-key=us-de-regs-official--title-16--13000-13460}

This section encompasses the mandatory categorically needy group of pregnant women, infants, and children. It also includes the adult expansion population and a family planning extension which were created under a Section 1115 Medicaid demonstration waiver.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13461** Pregnant Women, Infants And Children {#sec-13000-13461 omnilex-key=us-de-regs-official--title-16--13000-13461}

The Omnibus Budget Reconciliation Act (OBRA) of 1986 established a categorically needy eligibility group of pregnant women, infants, and children. Coverage was expanded by OBRA '87 and the Medicare Catastrophic Coverage Act (MCAA) of 1988.

On October 1, 1992, Delaware expanded Medicaid coverage to low income children up to age 18. On July 1, 1993, coverage was expanded to cover children up to age 19.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13462** Adult Expansion Population {#sec-13000-13462 omnilex-key=us-de-regs-official--title-16--13000-13462}

On May 17, 1995, CMS approved a Section 1115 Demonstration Project, entitled Diamond State Health Plan. This demonstration waiver extends Medicaid coverage to uninsured individuals age 19 or over with income at or below 100% of the FPL who are not categorically eligible.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13470** Breast and Cervical Cancer Group {#sec-13000-13470 omnilex-key=us-de-regs-official--title-16--13000-13470}

Effective October 1, 2001, Delaware added an optional categorically needy group for uninsured women under age 65 who are in need of treatment for breast or cervical cancer.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13500** Allocation Of Medicaid Responsibilities {#sec-13000-13500 omnilex-key=us-de-regs-official--title-16--13000-13500}

The Medicaid Unit has several functional groups of employees:

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13510** Function Of Medicaid Units {#sec-13000-13510 omnilex-key=us-de-regs-official--title-16--13000-13510}

The following 13500 sections describe the function of various Medicaid units.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13520** State Office Administrative Staff {#sec-13000-13520 omnilex-key=us-de-regs-official--title-16--13000-13520}

The State Office Administrative Staff is responsible for ongoing program and policy issues to assure that the Medicaid program meets Federal and State rules and regulations. These responsibilities include:

A. developing and maintaining policy and procedure manuals for eligibility staff, medical providers, and administrative staff,

B. developing the annual Medicaid budget and tracking expenditures,

C. developing contracts with, and enrolling, medical providers,

D. determining appropriate service coverage issues,

E. researching, evaluating and reporting on fiscal and operational impacts of proposed Federal and State program initiatives,

F. recommending and implementing fee structures,

G. monitoring fiscal agent activities,

H. auditing and performing utilization reviews of medical providers including imposing provider sanctions

I. monitoring the liability of other health insurance plans to pay for medical costs incurred by Medicaid recipients and recovering funds from these plans and the administration of a long term care estate recovery program,

J. planning and implementing new programs,

K. contracting with, and overseeing, other State and private agencies for auditing and monitory various facets of the Medicaid program as required by Federal law.

Distinct units within the State Office include:

A. the Administrative Support Unit which oversees:

1. the Surveillance and Utilization Review Unit (SUR)

2. the Budget/Data Management Unit (BDMU)

B. the Third Party Liability Unit (TPL)

C. the Claims Resolution and Medical Policy Unit

D. the Program Implementation Unit (PIU)

E. the Managed Care Unit

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13530** Primary Case Worker Units {#sec-13000-13530 omnilex-key=us-de-regs-official--title-16--13000-13530}

The Primary Case Workers determine eligibility for Medicaid groups other than nursing facilities, home and community based waivers, 30-day acute care hospital, and certain SSI-related groups.

Besides determining initial eligibility, these units also periodically redetermine eligibility. They are the primary contact with the Medicaid eligible population for resolving a wide variety of problems related to their own cases.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13540** Long-Term Care Units {#sec-13000-13540 omnilex-key=us-de-regs-official--title-16--13000-13540}

The Long Term Care Units determine financial and medical eligibility for:

A. nursing home care

B. home and community-based services

C. 30 day inpatient hospital services.

These units also complete redeterminations of eligibility and the same type of problem resolution as the Primary Case Worker units.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13600** Medicaid Administrative Interaction {#sec-13000-13600 omnilex-key=us-de-regs-official--title-16--13000-13600}

The following 13600 sections describe the interactions of various state and federal processes.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13610** Centers for Medicare and Medicaid Services (CMS) {#sec-13000-13610 omnilex-key=us-de-regs-official--title-16--13000-13610}

The Centers for Medicare and Medicaid Services (CMS) is the Federal regulatory agency which governs the Medicaid program. This agency provides technical assistance to the states as well as overseeing the funds expended by the Federal government on the Medicaid program. CMS representatives monitor program activity, and carry approval rights over all program changes. As part of its responsibilities, CMS assures that regulations comply with laws governing the Medicaid program. This process is described below.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13620** Legislative And Administrative Process To Create Medicaid Programs {#sec-13000-13620 omnilex-key=us-de-regs-official--title-16--13000-13620}

The Medical Assistance Program, like other government programs, is tightly regulated and operates daily using regulations and procedures that are based on a diversity of legislation and administrative policies. Because of these policies and legislation, Medicaid is a responsive, dynamic program. When the public raises issues of human rights and needs, the process that addresses those concerns is begun. Once laws are in place, an active system for updating and improving them is continually underway.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13630** Legislation To Law Process {#sec-13000-13630 omnilex-key=us-de-regs-official--title-16--13000-13630}

In its most basic forms, the process works something like this:

Law - A law or rule is established that indicates what the government's official position will be.

Regulation - A regulation written from that law establishes what standards and other considerations will be followed upholding the law.

For example: Regulations would establish what is meant by "dependent," the age limits for being considered a "child," what income and resources are considered "poverty" level.

Procedures - Procedures are developed from the regulation to define the practical steps eligibility workers will follow to process the actual cases.

For example: "To determine a client's income," you will need to obtain: wage or salary statements; etc.

This system of laws to regulations to procedures is the core of the process. However, more than this is involved. The following steps help to complete the picture.

A. An issue of public concern receives attention through the courts, lobbying, the media, etc.

B. A member of Congress writes a bill and submits it for Congressional and Executive approval.

C. After the bill is passed, Federal regulations are drawn by Centers for Medicare and Medicaid Services, an arm of the Department of Health and Human Services, which oversees the Medicaid Program to insure that the essence of the new law is maintained in daily operation.

D. The states are notified of the new law by Centers for Medicare and Medicaid Services (CMS) and receive an accompanying set of regulations. Any program changes required by the new regulations are then accommodated by revisions to the State Plan. The State Plan is a contract between the state Medicaid Agency and CMS which oversees state administration of the Medicaid Program.

E. State Plan amendments are then translated into Medicaid program policy manuals which implement the new provisions.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13640** The Social Security Administration (SSA) {#sec-13000-13640 omnilex-key=us-de-regs-official--title-16--13000-13640}

The Social Security Administration (SSA) is responsible for determining Medicaid eligibility under Section 1634 of Title XVI of the Social Security Act for individuals aged, blind or disabled. This is accomplished by determining eligibility for Supplemental Security Income (SSI) which automatically qualifies an eligible individual for Medicaid in Delaware. SSA also determines eligibility for State Supplementary Payments (SSP) for individuals residing in adult residential care arrangements.

In addition, DHSS has an agreement with SSA for Medicaid to purchase Medicare coverage on behalf of certain Medicaid eligible persons. This is known as the “Buy-In Agreement.

SSA’s responsibilities include providing any needed information on an SSI or SSP applicant to:

A. determine retroactive Medicaid eligibility,

B. make appropriate payments for Medicare Part B, and in some cases, Part A premiums,

C. assure that Medicaid has complete third party insurance information, and

D. give DHSS accurate and up-to-date information on the amount of SSA, SSI and SSP benefits for each eligible individual.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13700** The Department Of Health and Social Services {#sec-13000-13700 omnilex-key=us-de-regs-official--title-16--13000-13700}

The Department of Health and Social Services (DHSS) is a large department that consists of many divisions that interact with the Medical Assistance Program.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13710** The Division Of Social Services {#sec-13000-13710 omnilex-key=us-de-regs-official--title-16--13000-13710}

The Division of Social Services administers the following assistance programs: Medicaid, Delaware Healthy Children Program, Delaware Prescription Assistance Program, Renal Care Program, Temporary Assistance to Needy Families, the General Assistance Program, the Food Stamp Program, the Refugee Resettlement Program, purchase of Day Care Service, and the Emergency Assistance Program.

13710.1 The Information Systems Unit

This unit includes staff dedicated to assuring that both the Delaware Client Information System (DCIS) and the Medicaid Management Information System (MMIS) support the various needs of the Medicaid program

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13720** The Division Of Services For Aging And Adults With Physical Disabilities (DSAAPD) {#sec-13000-13720 omnilex-key=us-de-regs-official--title-16--13000-13720}

This division provides adult protective services and ombudsman services to Medicaid eligible and other persons. Any abuse or neglect of adults in long term care facilities must be reported to the Ombudsman's office.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13730** The Division Of Substance Abuse And Mental Health (DSAMH) {#sec-13000-13730 omnilex-key=us-de-regs-official--title-16--13000-13730}

This division has responsibility for Medicaid funded services such as Delaware Psychiatric Center's Medicaid certified long-term care and hospital facility and mental health support services which are targeted at avoiding institutionalization.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13740** The Division Of Management Services (DMS) {#sec-13000-13740 omnilex-key=us-de-regs-official--title-16--13000-13740}

This division has the responsibility for the overall fiscal management of the DHSS. In this capacity, they monitor expenditures within the Medicaid program and request the Federal matching dollars for the program.

13740.1 Audit and Recovery Management Services (ARMS)

This unit accepts referrals from DSS in cases of suspected recipient fraud.

13740.2 Information and Resources Management (IRM)

This unit supports DSS computer systems including DCIS, MMIS, and the Banyan network.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13750** The Division of Child Support Enforcement (DCSE) {#sec-13000-13750 omnilex-key=us-de-regs-official--title-16--13000-13750}

This is the agency responsible for assuring, for Medicaid purposes, that support orders include medical support (requirement for absent parents to purchase health care insurance for Medicaid eligible). DCSE also collects information about existing health care insurance coverage and communicates that information to the Medicaid TPL Unit.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13760** The Division of Developmental Disabilities Services (DDDS) {#sec-13000-13760 omnilex-key=us-de-regs-official--title-16--13000-13760}

This division is administratively responsible for the care of patients in Stockley Center ICF/MR Group Homes. Medicaid is primary funding source for much of this care. The Division also manages the Home and Community-Based Waiver for the developmentally disabled, a Medicaid funded program that has as its goal the deinstitutionalization of individuals with a developmental disability who can be maintained in a supportive community setting.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13770** The Division Of Public Health (DPH) {#sec-13000-13770 omnilex-key=us-de-regs-official--title-16--13000-13770}

This division is the agency responsible for the operation of many Medicaid reimbursable services such as:

A. Intermediate Care Facility (ICF) services in Emily P. Bissell Hospital, Delaware Hospital for the Chronically Ill (DHCI) and Governor Bacon Health Center (GBHC).

B. Skilled nursing services in Emily P. Bissell Hospital and Delaware Hospital for the Chronically Ill (DHCI).

C. Early and Periodic Screening Diagnosis and Treatment (EPSDT) clinics, including dental clinics,

D. Medical treatment clinics.

In addition, DPH has a cooperative agreement with Kent General Hospital to assist in the operation of the OB/GYN clinic that serves all of the pregnant non-insured and Medicaid patients in Kent County.

Part of the Division of Public Health is the Office of Health Facilities Licensing and Certification which is responsible for:

A. inspection and evaluation of long-term care facilities, neighborhood group homes, home health agencies, and laboratories in order to made recommendations to the State Board of Health regarding licensure,

B. evaluating and certifying the above groups for participation in the Medicare and Medicaid programs,

C. nurse aide certification and registry.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13780** The Division Of State Service Centers (DSSC) {#sec-13000-13780 omnilex-key=us-de-regs-official--title-16--13000-13780}

This division has a contract with Medicaid to provide transportation for children to the Division of Public Health EPSDT dental and medical services.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13800** Other Departments of The State {#sec-13000-13800 omnilex-key=us-de-regs-official--title-16--13000-13800}

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13810** The Department Of Services to Children, Youth And Their Families (DSCYF) {#sec-13000-13810 omnilex-key=us-de-regs-official--title-16--13000-13810}

This department is responsible for:

A. the majority of the State’s foster children,

B. special needs children whose adoptive parents are receiving a Federally funded adoption assistance payment or a State funded adoption subsidy.

DSCYF also has the responsibility for providing information to Medicaid to assist in determining and redetermining eligibility for Medicaid for these children.

DSCYF works with Medicaid to determine where the program needs to be expanded to improve health care accessibility for foster and adoptive children as well as to maximize the use of Federal dollars.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13900** Supportative Companies/Agencies/Individuals {#sec-13000-13900 omnilex-key=us-de-regs-official--title-16--13000-13900}

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13910** The Medicaid Fiscal Agent {#sec-13000-13910 omnilex-key=us-de-regs-official--title-16--13000-13910}

This agent is the private company that contracts with Medicaid to handle all of the bills that are submitted by medical providers to appropriately manage payments to providers and assure compliance with Federal reporting requirements. Effective July 1, 1990, the Medicaid Fiscal Agent is Electronic Data Systems (EDS).

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13920** Legal And Medical Consultants {#sec-13000-13920 omnilex-key=us-de-regs-official--title-16--13000-13920}

Consultants are used by Medicaid staff in areas where medical expertise is needed to make decisions on claims payment or coverage issues. The Medicaid program retains a Medical Director along with a part-time pharmacy, optometric and laboratory consultants on a contractual basis. These consultants are available weekly or as needed by telephone. Other consultants, such as physicians with expertise in the areas of orthopedics, pathology, neurology and rehabilitation are hired on an as needed basis.

The Deputy Attorney General in the Department of Justice provides legal assistance.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13930** The Medical Care Advisory Committee {#sec-13000-13930 omnilex-key=us-de-regs-official--title-16--13000-13930}

The Medical Care Advisory Committee is a group of medical providers, community advocates and consumers who, by Federal mandate, are structured to provide guidance to the Medicaid program, to recommend program improvements, and to serve as an advocate for needed change within the State system.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

##### **16 Del. Admin. Code § 13000-13940** The Medicaid Fraud Control Unit {#sec-13000-13940 omnilex-key=us-de-regs-official--title-16--13000-13940}

The Medicaid Fraud Control Unit of the Attorney General’s office conducts Medicaid provider fraud investigations. Referrals to the Fraud Unit are usually made by the Medicaid Surveillance and Utilization Review Unit (SUR) as a result of field audits of providers. However, referrals may be made by anyone suspecting fraud, abuse or violation of any State or Federal law or medical practice by a Medicaid provider.

**History**
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 323 (10/01/22)*
- *14 DE Reg. 661 (01/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 202 (08/01/11)*

#### **14000** Medicaid General Eligibility Requirements

##### **16 Del. Admin. Code § 14000** Medicaid General Eligibility Requirements {#sec-14000 omnilex-key=us-de-regs-official--title-16--14000}

This section describes the general eligibility requirements for Medicaid.

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14100** General Application Information {#sec-14000-14100 omnilex-key=us-de-regs-official--title-16--14000-14100}

The application will be the single, streamlined application for all insurance affordability programs developed by the Centers for Medicare and Medicaid Services (CMS) or an alternative single, streamlined application for all insurance affordability programs as approved by CMS.

For individuals applying, or who may be eligible, on a basis other than a determination based on the modified adjusted gross income (MAGI) methodologies described in Section 16000, the agency will use:

The application may be submitted via the Internet web site established by the Federally Facilitated Marketplace (FFM), via the agency’s Application for Social Service and Internet Screening Tool (ASSIST) self-service Internet web site, by telephone, via mail, in person with reasonable accommodations for those with disabilities, as defined by the Americans with Disabilities Act (ADA), and through other commonly available electronic means.

The FFM is a competitive marketplace for individuals and small employers to directly compare available health insurance options. The FFM will conduct basic screening and an assessment for potential Medicaid eligibility and transmit the information provided on the application to the agency for an eligibility determination as described in Section 14100.8 Coordination of Eligibility and Enrollment with Other Insurance Affordability Programs.

The application must be signed under penalty of perjury. Electronic, including telephonically recorded, signatures and handwritten signatures transmitted via any other electronic transmission are accepted.

When an application is completed online, the date of application is the date the application is submitted online. The date of application for a paper application will be the date of receipt in an agency office or the date of the postmark if received via the United States Postal Service (USPS). The application filing date is used to determine the earliest date for which Medicaid can be effective. Medicaid eligibility is effective the first day of the month if the individual was eligible at any time during that month provided the individual was a Delaware resident on the first of the month. If not a Delaware resident on the first of the month, Medicaid will be effective the date the individual became a Delaware resident.

Assistance will be provided to any individual seeking help with the application or renewal process in person, over the telephone, online, and in a manner that is accessible to individuals with disabilities and those who are limited English proficient.

14100.1 Authorized Representatives

Applicants and beneficiaries are permitted to designate an individual or organization to act responsibly on their behalf in assisting with the individual’s application and renewal of eligibility and other ongoing communications with the agency. The designation must be in writing, including the applicant’s signature, and is permitted at the time of application and at other times.

Legal documentation of authority to act on behalf of an applicant or beneficiary under state law, such as a court order establishing legal guardianship or a power of attorney, shall serve in the place of written authorization by the applicant or beneficiary. The authorized representative must agree to maintain, or be legally bound to maintain, the confidentiality of any information regarding the applicant or beneficiary provided by the agency.

The agency will accept electronic, including telephonically recorded, signatures and handwritten signatures transmitted by facsimile or other electronic transmission. Designation of authorized representatives will be accepted via ASSIST self-service web site, by telephone, via mail, in person, and through other commonly available electronic means.

Representatives may be authorized to:

The power to act as an authorized representative is valid until the applicant or beneficiary modifies the authorization or notifies the agency the representative is no longer authorized to act on his or her behalf, or there is a change in the legal authority upon which the individual or organization’s authority was based. This notification to the agency must be in writing and should include the individual’s or authorized representative's signature as appropriate.

As a condition of serving as an authorized representative, a provider or staff member or volunteer of an organization must sign an agreement that he or she will adhere to the regulation in:

14100.2 Protected Filing Date

An individual’s application filing date may be established based on either a written statement or an oral inquiry about Medicaid eligibility. An oral inquiry is a discussion about Medicaid eligibility for a specific person that results in a request for Medicaid. An oral inquiry must be documented when received. An oral inquiry or a written statement protects the filing date if a written application is completed and received in a DSS office within 30 days from the date of inquiry. When an application is received in the mail, the date of the postmark is considered the date of receipt. A postmark is the U.S. Postal Service mark stamped on a piece of mail canceling the postage stamp and recording the date and place of sending. An oral inquiry or written statement protects the filing date if an application is received within 30 days from the date of the inquiry.

14100.3 Interview Requirement for Some Eligibility Groups

An in-person interview is not required for any eligibility group subject to the modified adjusted gross income (MAGI)-based methodologies described in Section 16000.

An in-person interview is not required for Long Term Care eligibility determinations. SEE SECTION 20101 - Application Process - Long-Term Care Services.

14100.4 Disposition of Applications

The agency must include in each applicant's case record facts to support the agency's decision on the individual’s application. The agency must dispose of each application by a finding of eligibility or ineligibility, unless there is:

a) an entry in the case record that the applicant voluntarily withdrew the application, and that the agency sent a notice confirming his decision;

b) a supporting entry in the case record that the applicant has died; or

c) a supporting entry in the case record that the applicant cannot be located.

An application must be reinstated effective as of the date the application was first received by the Federally Facilitated Marketplace (FFM) in cases where the individual:

a) submitted an application via the FFM and is assessed as not potentially eligible for Medicaid;

b) withdrew the application for Medicaid; and

c) is assessed as potentially eligible for Medicaid by the FFM appeals entity.

All applicants will receive a notice of acceptance or denial.

14100.5 Determination of Eligibility

A determination of eligibility includes:

a) an approval or denial of eligibility for applicants;

b) a renewal of eligibility for beneficiaries;

c) a termination of eligibility for beneficiaries; and

d) a redetermination of eligibility between a regularly scheduled renewal based on a change reported or identified.

Each applicant or beneficiary who meets the non-financial eligibility requirements will have a determination of financial eligibility based on MAGI methodology. For an applicant or beneficiary found not eligible based on MAGI methodology and who has been identified on the application or renewal form as potentially eligible on a MAGI-excepted basis, a determination of eligibility will be made on such basis. In addition, an individual may request a determination of eligibility on a basis other than MAGI.

The agency will consider all categories of eligibility prior to a termination of eligibility. For individuals determined ineligible for Medicaid, the agency will determine potential eligibility for other insurance affordability programs in accordance with Section 14100.8 Coordination of Eligibility and Enrollment with Other Insurance Affordability Programs.

14100.5.1 Timely Determination of Eligibility

The following Federal standards have been established for determining eligibility and informing applicants of the decision:

a. Ninety days (90) for applicants who apply for Medicaid on the basis of disability. This includes long term care and Children’s Community Alternative Disability Program.

b. Forty-five (45) days for all other applicants.

The standards cover the period from the date of application with the agency or the date the application is transferred via the Federally Facilitated Marketplace (FFM) to the date the agency notifies the applicant of its decision.

The standards must be met except in unusual circumstances, such as:

a. A decision cannot be made because the applicant, his representative or his physician delays or fails to take a required action.

b. There is an administrative or other emergency beyond the Division's control.

The time standards must not be used as a waiting period before determining eligibility or as a reason for denying eligibility (because a decision has not been reached within the required time). Decision on applications should be made as quickly as possible, but if the final determination does not fall within the prescribed limits, the record must have documentation of the reasons for delay.

14100.6 Annual Renewal of Eligibility

42 CFR 435.916

The eligibility of Medicaid beneficiaries must be renewed once every 12 months and no more frequently than once every 12 months. The agency will redetermine eligibility without requiring information from the individual if able to do so based on reliable information contained in the individual’s record or other more current information available to the agency. Information available to the agency includes but is not limited to information accessed through the electronic data sources described in DSSM 14800 - Verifications of Factors of Eligibility.

If the agency is able to renew eligibility based on the available information, the agency will notify the individual of:

If the agency cannot renew eligibility as described above, the agency will provide the individual with a pre-populated renewal form. The pre-populated renewal form will contain information available to the agency about factors of eligibility. The renewal form will also include basic screening questions necessary to indicate potential eligibility on a basis other than modified adjusted gross income (MAGI).

The individual will be given 30 days from the date of the renewal form to respond. The individual must provide any additional information requested and sign and return the renewal form. The request for additional information from the individual will be limited to only the information needed to renew eligibility. The individual may return the additional information and the renewal form through any of the submission modes described above.

If the individual does not respond to the renewal form and provide the additional information requested and eligibility is terminated on that basis, eligibility can be reconsidered if the individual responds within 90 days after the date of termination. The individual is not required to submit a new application. Coverage may extend back to the date of termination provided the individual is found eligible as described in DSSM 14920 - Retroactive Coverage.

The agency will consider all categories of eligibility prior to a termination of eligibility as described in DSSM 14100.5 - Determination of Eligibility.

14100.7 Fair Hearings

A fair hearing is an administrative hearing held in accordance with the principles of due process. An opportunity for a fair hearing will be provided, subject to the provisions in policy at DSSM Fair Hearing Section. Any individual who is dissatisfied with a decision of the Division of Social Services may request a fair hearing. See DSSM Fair Hearing Section for policies covering fair hearings.

14100.8 Coordination of Eligibility and Enrollment with Other Insurance Affordability Programs

The following words and terms, when used in the context of these policies, will have the following meaning unless the context clearly indicates otherwise.

“Coordinated content” means information included in an eligibility notice regarding the transfer of the individual’s or households’ electronic account to the Federally Facilitated Marketplace (FFM) for a determination of eligibility for another insurance affordability program.

“Electronic account” means an electronic file that includes all information collected and generated by the agency regarding each individual’s Medicaid eligibility and enrollment including any information collected or generated as part of the agency fair hearing process or the FFM appeals process.

“Insurance affordability program” means a program that is one of the following:

1) Medicaid

2) Delaware Healthy Children Program

3) a State basic health program established under section 1331 of the Affordable Care Act

4) a program that makes available coverage in a qualified health plan through the FFM with advance payments of the premium tax credit established under section 36B of the Internal Revenue Code available to qualified individuals

5) a program that makes available coverage in a qualified health plan through the FFM with cost-sharing reductions established under section 1402 of the Affordable Care Act.

“Secure electronic interface” means an interface which allows for the exchange of data between Medicaid and other insurance affordability programs and adheres to the requirements in 42 CFR Part 433 subpart C.

14100.8.1 Transfer from Other Insurance Affordability Programs to the State Agency

For individuals who have been assessed by the FFM (including as a result of a decision made by the FFM appeals entity) as potentially Medicaid eligible the agency must:

14100.8.2 Evaluation of Eligibility for Other Insurance Affordability Programs

For individuals who submit an application; return a renewal form; or whose eligibility is being redetermined due to a change in circumstances; and who are found ineligible for Medicaid, the agency will:

14100.8.3 Individuals Undergoing a Medicaid Eligibility Determination on a Basis other than MAGI

For individuals with household income greater than the applicable MAGI standard and for whom the agency is determining eligibility on another basis, the agency must promptly and without undue delay:

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14105** Social Security Number {#sec-14000-14105 omnilex-key=us-de-regs-official--title-16--14000-14105}

Each individual applying for Medicaid, except as provided in this section, must furnish his or her Social Security number (SSN) as a condition of eligibility. If the individual cannot furnish a SSN, he or she must provide proof of an application for a SSN with the Social Security Administration (SSA). The agency will assist the applicant with the completion of an application for a SSN.

The SSN furnished will be verified with the Social Security Administration (SSA) via Federal Data Services Hub (FDSH) in accordance with Section 14800 Verifications of Factors of Eligibility. Eligibility will not be denied or delayed pending the issuance or verification of the SSN.

An individual whose income will be considered when determining eligibility for an applicant will be asked to furnish his or her SSN on the application. When the SSN of a financially responsible individual is voluntarily furnished, the SSN will be verified with SSA via the FDSH.

14105.1 Exception to Furnish a Social Security Number (SSN)

The requirement to furnish a SSN does not apply to an individual who:

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14110** State Residency {#sec-14000-14110 omnilex-key=us-de-regs-official--title-16--14000-14110}

An applicant or beneficiary must be a Delaware resident.

14110.1 Definitions

The following words and terms, when used in the context of these policies, will have the following meaning unless the context clearly indicates otherwise:

Per 42 CFR 435.403(b), “Institution” has the same meaning as Institution and Medical Institution as defined in 42 CFR 435.1010. For purposes of state placement, the term also includes foster care homes, licensed as set forth in 45 CFR 1355.20, and providing food, shelter, and services to one or more persons unrelated to the proprietor.

Per 42 CFR 435.403(c), an individual is “Incapable of indicating intent” if the individual –

a) Has an I.Q. of 49 or less or has a mental age of 7 or less, based on tests acceptable to the Delaware

Division of Developmental Disabilities;

b) Is judged legally incompetent; or

c) Is found incapable of indicating intent based on medical documentation obtained from a physician,

psychologist, or other person licensed by the State in the field of intellectual disability.

14110.2 Placement by State in an Out-Of-State Institution

(42 CFR 435.403 (e))

An individual who is placed in an institution in another State by a Delaware agency including an entity recognized under State law as being under contract with the State for such purposes is considered a Delaware resident. The State arranging or actually making the placement is considered as the individual's State of residence. Any action beyond providing information to the individual and the family constitutes arranging or making a State placement.

14110.3 Actions which do not Constitute State Placement

(42 CFR 435.403 (e))

The following actions do not constitute State placement:

a. Providing basic information to the individual about another State's Medicaid program and information about the availability of services and facilities in another State.

b. Assisting an individual in locating an institution in another State, provided the individual is capable of indicating intent and independently decides to move.

c. When a competent individual leaves the facility in which he/she is placed by State, the individual’s State of residence for Medicaid purposes is the State where the individual is physically located.

14110.4 Lack of Appropriate Facility

(42 CFR 435.403 (e))

Where a placement is initiated by a State because the State lacks a sufficient number of appropriate facilities to provide services to its residents, the State making the placement is the individual's State of residence.

14110.5 [Reserved]

14110.6 Individuals Receiving a State supplementary payment (SSP)

Per 42 CFR 435.403(f)

Individuals of any age who are receiving an SSP, the State of residence is the State paying the SSP.

14110.7 Individuals Receiving Title IV-E Payments

Per 42 CFR 435.403(g)

Individuals of any age who are receiving Federal payments for foster care or adoption assistance under title IV-E of the Social Security Act, the State of residence is the State where the child lives.

14110.8 Individuals Under Age 21

42 CFR 435.403(i)

For an individual under age 21 who is not eligible for Medicaid based on receipt of assistance under title IV-E of the Act, as addressed 14110.7 of this section, and is not receiving a State supplementary payment, as addressed in paragraph 14110.6 of this section, the State of residence is as follows:

a) For an individual who is capable of indicating intent and is married or emancipated from his or her parent, and is not residing in an institution, the State of residence is where the individual is living; and

b) For an individual not described in a) and not living in an institution, the State of residence is:

c) For an institutionalized individual who is neither married nor emancipated, the State of residence is:

14110.8.1 Prohibitions

[Repealed, effective October 11, 2019.]

14110.8.2 Exceptions

[Repealed, effective October 11, 2019.]

14110.9 Individuals Age 21 and Over

42 CFR 435.403(h)

For an individual over age 21 who is not eligible for Medicaid based on receipt of assistance under title IV-E of the Act, as addressed 14110.7 of this section, and is not receiving a State supplementary payment, as addressed in paragraph 14110.6 of this section, the State of residence is as follows:

a) For an individual not residing in an institution, the State of residence is the state where the individual is living and:

b) For an individual not residing in an institution and who is not capable of stating intent, the State of residence is the state where the individual is living.

c) For any institutionalized individual who became incapable of indicating intent before age 21, the State of residence is:

d) For any institutionalized individual who became incapable of indicating intent at or after age 21, (irrespective of any type of guardianship) the State of residence is the state in which the individual is physically present, except where another state makes a placement.

e) For any other institutionalized individual, the State of residence is the state where the individual is living and intends to reside.

14110.10 Specific Prohibitions for Denial or Termination of Eligibility

42 CFR 435.403(j); 42 CFR 435.956(c)(2)

Per 42 CFR 435.956(c)(2), Evidence of immigration status may not be used to determine that an individual is not a State resident.

A State cannot deny Medicaid eligibility to otherwise qualified resident of the State because:

a) The individual's residence is not maintained permanently or at a fixed address.

b) The individual has not resided in the State for a specific period of time; or

c) An institutionalized individual did not establish residence in the community prior to admission to an institution.

A State cannot terminate Medicaid eligibility for an otherwise qualified resident of the State due to temporary absence from the State if the person intends to return when the purpose of the absence has been accomplished, unless another State has determined that the person is a resident there for purposes of Medicaid.

A State cannot wait to approve Medicaid eligibility in situations where the individual has moved to Delaware from another State and the Medicaid case is still open in the former State. The individual is no longer a resident of the former State and is ineligible in that State. The case may not be closed yet due to administrative processes.

14110.11 Exceptions to General Residency Rules

When the following exists, it supersedes the general residency rules:

a) When two or more States cannot resolve which State is the State of residence, the State in which the individual is physically located is the State of residence.

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14120** Inmate of a Public Institution {#sec-14000-14120 omnilex-key=us-de-regs-official--title-16--14000-14120}

Statutory Authority

Patient Protection and Affordable Care Act (ACA, P.L.111-148, as amended)

Inmates of a public institution who are held involuntarily may be enrolled in Medicaid if otherwise eligible, but Medicaid may not provide coverage for most services while the individual is detained. The inmate may be eligible for Medicaid coverage of services as an inpatient in a medical institution if admitted to the medical institution for more than 24 hours.

An inmate of a public institution is a person who is living in a public institution. A public institution is a facility that is under the responsibility of a governmental unit or over which a governmental unit exercises administrative control. This control can exist when a facility is actually an organizational part of a governmental unit or when a governmental unit exercises final administrative control, including ownership and control of the physical facilities and grounds used to house inmates. Administrative control can also exist when a governmental unit is responsible for the ongoing daily activities of a facility; for example, when facility staff members are government employees or when a government unit, board, or officer has final authority to hire and fire employees. Privately supported institutions that are not under the control of a governmental unit do not meet the definition of a public institution.

An individual is an inmate and is not eligible when he or she is serving time for a criminal offense or is confined involuntarily awaiting trial, criminal proceedings, penal dispositions, or other involuntary detainment determinations and is living in:

a.

State or Federal prison

b.

jail

c.

a detention facility

d.

a wilderness camp under government control

e.

a halfway house under government control

f.

any penal facility

The following individuals are not inmates of a public institution and may be eligible:

1.

An individual who is voluntarily living in a public institution after his or her case has been adjudicated and other living arrangements are being made (such as transfer to a community residence).

2.

An individual who is sent to a privately supported institution as an alternative to a detention or prison sentence.

3.

Infants living with the inmate in the public institution.

4.

Parolees.

5.

Probationers.

6.

Individuals living in a halfway house that is not under governmental control.

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14300** Citizenship and Alienage {#sec-14000-14300 omnilex-key=us-de-regs-official--title-16--14000-14300}

Medicaid must be provided to eligible citizens or nationals of the United States. An individual qualifies as a U.S. citizen if the person was born in the 50 states and District of Columbia, Puerto Rico, Guam, U.S. Virgin Islands, or Northern Mariana Islands. Nationals from American Samoa or Swain's Island are regarded as U.S. citizens for purposes of Medicaid eligibility. Children of a U.S. citizen who are born outside the U.S. may automatically be eligible for a Certificate of Citizenship.

The Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (PRWORA, P.L. 104-193) enacted on August 22, 1996, significantly changed Medicaid eligibility for individuals who are not citizens of the U. S. The legislation revised the categories of noncitizens who may be determined eligible for Medicaid. The legislation identifies noncitizens as qualified aliens or nonqualified aliens. Medicaid eligibility for aliens is based on whether the alien is a qualified or nonqualified alien. The term nonqualified alien also includes illegal aliens.

All applicants, whether citizens or aliens, must meet the technical and financial eligibility criteria of a specific eligibility group such as SSI related group, AFDC related group, or poverty level related group. Not every alien, qualified or nonqualified, will be eligible for Medicaid or emergency services and labor and delivery only.

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14310** Qualified Aliens {#sec-14000-14310 omnilex-key=us-de-regs-official--title-16--14000-14310}

A qualified alien is:

a) An alien who is lawfully admitted for permanent residence under the Immigration and Nationality Act (INA).

b) A refugee who is admitted to the United States under §207 of the INA.

c) An alien who is granted asylum under §208 of the INA.

d) An alien whose deportation is being withheld under §243(h) of the INA or §241(b)(3) of the INA.

e) An alien who is paroled into the United States under §212(d)(5) of the INA for a period of at least 1 year.

f) An alien granted conditional entry pursuant to §203(a)(7) of the INA as in effect before April 1, 1980.

g) Honorably discharged veterans and aliens on active duty in the U.S. armed forces and the spouse or unmarried dependent children of a veteran or active duty serviceman. The discharge must not be due to alien status and the active duty status must not be for training. For example, the 2 weeks of active duty training usually required of members of the National Guard does not meet the definition of active duty. Hmong and other Highland Lao veterans who fought on behalf of the Armed Forces of the U.S. during the Vietnam conflict and who have lawfully been admitted for permanent residence are considered veterans.

h) An alien granted status as a Cuban and Haitian entrant (as defined in Section 501(e) of the Refugee Education Assistance Act of 1980).

i) An alien admitted to the U.S. as an Amerasian immigrant pursuant to Section 584 of the Foreign Operations, Export Financing, and Related Programs Appropriations Act, 1988.

j) Aliens who have been subjected to battery or extreme cruelty and who meet certain criteria, including an alien whose child has been battered or an alien child whose parent has been battered.

k) An American Indian born in Canada who is at least one-half American Indian blood and to whom the provisions of §289 of the INA apply or who is a member of an Indian tribe under section 4(e) of the Indian Self-Determination and Education Assistance Act.

l) Victims of trafficking under the Trafficking Victims Protection Act of 2000 including certain family members of victims of a severe form of trafficking.

m) Iraqi and Afghan special immigrants under The Department of Defense Appropriations Act of 2010. These immigrants are treated in the same manner as refugees.

14310.1 Five Year Bar

Unless specifically exempt, qualified aliens who enter the U.S. on or after August 22, 1996, are subject to a five-year bar from Medicaid. While subject to the five-year bar from full Medicaid, a qualified alien may be eligible for emergency services and labor and delivery only.

14310.2 Aliens Exempt from Five Year Bar

The following qualified aliens are exempt from the five-year bar:

·

Refugees (§207 of INA)

·

Asylees (§208 of INA)

·

Aliens who have had deportation withheld under §243(h) or §241(b)(3) of the

·

INA

·

Honorably discharged veterans and aliens on active duty in the U.S. armed forces

·

and the spouse or unmarried dependent children of a veteran or active duty serviceman.

·

Cuban and Haitian entrants

·

Amerasians

·

An American Indian born in Canada, Mexico or who is a member of an Indian

·

tribe under section 4(e) of the Indian Self-Determination and Education Assistance Act

·

Victims of trafficking

·

Iraqi and Afghan special immigrants

·

Legal permanent residents (LPR) who first entered the U.S. under an exempt

·

category (such as refugee, asylee, Cuban/Haitian entrant) and later converted to LPR

In addition, title IV-E Foster Children and Adoption Assistance children may be found eligible for Medicaid regardless of the date of entry provided the foster or adoptive parent of the child is also a qualified alien or a citizen. The IV-E agency is responsible for making that determination about the parent. If a IV-E payment is being made on behalf of the child, then the child is deemed eligible for Medicaid.

14310.3 Date of Entry before August 22, 1996

An alien who entered the U.S. before August 22, 1996, and obtained qualified alien status before that date, may be found eligible for full Medicaid benefits.

An alien who entered the U.S. before August 22, 1996, but obtained qualified alien status on or after that date, is not subject to the five-year bar provided the alien remained continuously present in the U.S. from the latest date of entry prior to August 22, 1996, until becoming a qualified alien. This also applies to aliens who entered the U.S without proper documentation or those who overstayed their visa.

Any single absence from the U.S. of more than 30 days, or a total aggregate of absences of more than 90 days, is considered to interrupt continuous presence. For most legal entrants, the United States Citizenship and Immigration Services (USCIS) maintains a record of arrivals to and departures from the U.S. Verification of continuous presence may be obtained by filing Form G-845 and Form G-845-Supplement with the USCIS. For some legal entrants, such as Canadian and Mexican border crossers, and for illegal entrants, the USCIS does not maintain an arrival and departure record. These aliens must provide proof of continuous presence, such as tax returns, employment records, or rent receipts.

Once an immigrant has obtained qualified alien status, he or she does not have to remain continuously present in the U.S.

14310.4 Date of Entry on or after August 22, 1996

An alien who entered the U.S. on or after August 22, 1996, is not eligible for full Medicaid benefits for five years. The alien may be eligible for emergency services and labor and delivery only. The five-year bar begins on the date the immigrant obtains qualified alien status.

14320 Legally Residing Nonqualified Aliens

These are aliens who do not meet the definition of a qualified alien. Individuals formerly known as PRUCOL are now considered nonqualified aliens. Nonqualified aliens have to provide a Social Security Number (SSN) if one is available, or apply for a SSN if the applicant does not have one.

Legally residing nonqualified aliens include the following:

1. A citizen of a Compact of Free Association State (Federated States of Micronesia, Republic of the Marshall Islands, and the Republic of Palau) who has been admitted to the U.S. as a non-immigrant and is permitted by the Department of Homeland Security to reside permanently or indefinitely in the U.S.

2. An individual described in 8 CFR section 103.12(a)(4) who does not have a permanent residence in the country of their nationality and is in a status that permits the individual to remain in the U.S. for an indefinite period of time, pending adjustment of status. These individuals include:

a) an individual currently in temporary resident status as an Amnesty beneficiary pursuant to section 210 or 245A of the INA

b) an individual currently under Temporary Protected Status pursuant to section 244 of the INA and pending applicants for Temporary Protected Status who have been granted employment authorization

c) a family unity beneficiary pursuant to section 301 of Public Law 101-649 as amended by, as well as pursuant to, section 1504 of Public Law 106-554

d) an individual currently under Deferred Departure pursuant to a decision made by the President

e) an individual who is the spouse or child of a U.S. citizen whose visa petition has been approved and who has a pending application for adjustment of status.

3. An individual in non-immigrant classifications under the INA who is permitted to remain in the U.S. for an indefinite period, including the following as specified in section 101(a)(15) of the INA:

a) a parent or child of an individual with special immigrant status under section 101(a)(27) of the INA, as permitted under section 101(a)(15)(N) of the INA

b) a fiancé of a citizen, as permitted under section 101(a)(15)(K) of the INA

c) a religious worker under section 101(a)(15)(R)

d) an individual assisting the Department of Justice in a criminal investigation, as permitted under section 101(a)(15)(S) of the INA

e) a battered alien under section 101(a)(15)(U)(see also section 431 as amended by PRWORA)

f) an individual with a petition pending for 3 years or more, as permitted under section 101(a)(15)(V) of the INA

4. An alien in nonimmigrant status who has not violated the terms of the status under which he or she was admitted or to which he or she has changed after admission.

5. An alien who has been paroled into the U.S. pursuant to section 212(d)(5) of the INA for less than one year, except for an alien paroled for prosecution, for deferred inspection or pending removal proceedings.

6. Aliens who have been granted employment authorization under 8 CFR 274a.12(c)(9), (10), (16), (18), (20), (22), or (24).

7. Aliens currently in deferred action status.

8. A pending applicant for asylum under section 208(a) of the INA or for withholding of removal under section 241(b)(3) of the INA or under the Convention Against Torture who has been granted employment authorization, and such an applicant under the age of 14 who has had an application pending for at least 180 days.

9. An alien who has been granted withholding of removal under the Convention Against Torture.

10. A child who has a pending application for Special Immigrant Juvenile status as described in section 101(a)(27)(J) of the INA.

11. An alien who is lawfully present in the Commonwealth of the Northern Mariana Islands under 48 U.S.C. § 1806(e).

12. An alien who is lawfully present in American Samoa under the immigration laws of American Samoa.

14320.1 Medicaid Eligibility for Legally Residing Nonqualified Aliens

Legally residing nonqualified aliens may be eligible for emergency services and labor and delivery only. Legally residing nonqualified aliens are not eligible for any long term care Medicaid program.

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14330** Illegally Residing Nonqualified Aliens {#sec-14000-14330 omnilex-key=us-de-regs-official--title-16--14000-14330}

The term nonqualified aliens also includes aliens who are illegally residing in the U.S. These aliens were never legally admitted to the U.S. for any period of time or were admitted for a limited period of time and did not leave the U.S. when the period of time expired. Aliens who are illegally residing in the U.S. do not have to provide a SSN.

14330.1 Medicaid Eligibility for Illegally Residing Nonqualified Aliens

Illegally residing nonqualified aliens may be eligible for emergency services and labor and delivery only. Illegally residing nonqualified aliens are not eligible for any long term care Medicaid program.

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14340** Ineligible Aliens {#sec-14000-14340 omnilex-key=us-de-regs-official--title-16--14000-14340}

[Repealed, effective October 11, 2019.]

14340.1 Medicaid Eligibility for Certain Ineligible Aliens

[Repealed, effective October 11, 2019.]

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14350** Legal Immigrant Pregnant Women and Children under age 21 {#sec-14000-14350 omnilex-key=us-de-regs-official--title-16--14000-14350}

Section 214 of the Children’s Health Insurance Program Reauthorization Act of 2009 (CHIPRA) authorizes coverage under Medicaid or CHIP for certain alien pregnant women and children who are lawfully residing in the United States and are otherwise eligible. Delaware will cover these certain alien pregnant women under Medicaid and will cover these certain alien children under Medicaid or CHIP. Eligibility under this section will be implemented with the earliest effective date of July 1, 2010. Children who are in one of the legal alien groups must have their immigration status verified at each annual redetermination. The documentation provided for the initial application may be used.

The alien groups who may be determined eligible under this section are:

1. An alien who is lawfully admitted for permanent residence under the INA, who entered the U.S. on or after August 22, 1996, and is subject to the five-year bar under PRWORA.

2. An alien who is paroled into the United States under §212(d)(5) of the INA for a period of at least 1 year who, entered the U.S. on or after August 22, 1996, and is subject to the five-year bar under PRWORA.

3. An alien granted conditional entry pursuant to §203(a)(7) of the INA as in effect before April 1, 1980, who entered the U.S. on or after August 22, 1996, and is subject to the five-year bar under PRWORA.

4. A citizen of a Compact of Free Association State (Federated States of Micronesia, Republic of the Marshall Islands, and the Republic of Palau) who has been admitted to the U.S. as a non-immigrant and is permitted by the Department of Homeland Security to reside permanently or indefinitely in the U.S.

5. An individual described in 8 CFR section 103.12(a)(4) who does not have a permanent residence in the country of their nationality and is in a status that permits the individual to remain in the U.S. for an indefinite period of time, pending adjustment of status. These individuals include:

a) an individual currently in temporary resident status as an Amnesty beneficiary pursuant to section 210 or 245A of the INA

b) an individual currently under Temporary Protected Status pursuant to section 244 of the INA and pending applicants for Temporary Protected Status who have been granted employment authorization

c) a family unity beneficiary pursuant to section 301 of Public Law 101-649 as amended by, as well as pursuant to, section 1504 of Public Law 106-554

d) an individual currently under Deferred Departure pursuant to a decision made by the President

e) an individual who is the spouse or child of a U.S. citizen whose visa petition has been approved and who has a pending application for adjustment of status.

6. An individual in non-immigrant classifications under the INA who is permitted to remain in the U.S. for an indefinite period, including the following as specified in section 101(a)(15) of the INA:

a) a parent or child of an individual with special immigrant status under section 101(a)(27) of the INA, as permitted under section 101(a)(15)(N) of the INA

b) a fiance´ of a citizen, as permitted under section 101(a)(15)(K) of the INA

c) a religious worker under section 101(a)(15)(R)

d) an individual assisting the Department of Justice in a criminal investigation, as permitted under section 101(a)(15)(S) of the INA

e) a battered alien under section 101(a)(15)(U)(see also section 431 as amended by PRWORA)

f) an individual with a petition pending for 3 years or more, as permitted under section 101(a)(15)(V) of the INA

7. An alien in nonimmigrant status who has not violated the terms of the status under which he or she was admitted or to which he or she has changed after admission.

8. An alien who has been paroled into the U.S. pursuant to section 212(d)(5) of the INA for less than one year, except for an alien paroled for prosecution, for deferred inspection or pending removal proceedings.

9. Aliens who have been granted employment authorization under 8 CFR 274a.12(c)(9), (10), (16), (18), (20), (22), or (24).

10. Aliens currently in deferred action status.

11. A pending applicant for asylum under section 208(a) of the INA or for withholding of removal under section 241(b)(3) of the INA or under the Convention Against Torture who has been granted employment authorization, and such an applicant under the age of 14 who has had an application pending for at least 180 days.

12. An alien who has been granted withholding of removal under the Convention Against Torture.

13. A child who has a pending application for Special Immigrant Juvenile status as described in section 101(a)(27)(J) of the INA.

14. An alien who is lawfully present in the Commonwealth of the Northern Mariana Islands under 48 U.S.C. § 1806(e).

15. An alien who is lawfully present in American Samoa under the immigration laws of American Samoa.

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14360** State Funded Benefits {#sec-14000-14360 omnilex-key=us-de-regs-official--title-16--14000-14360}

In State Fiscal Year 1998, (SFY 98), the Delaware legislature appropriated state only funds to provide coverage of full Medicaid benefits to certain legally residing noncitizens who are ineligible for full Medicaid benefits because of PRWORA. This did not include long term care services. Coverage for these aliens was subject to the availability of state funding. Effective July 1, 2011, state funded benefits are no longer available for these certain legally residing noncitizens. These aliens may be found eligible for emergency services and labor and delivery only.

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14370** Coverage of Emergency Services and Labor and Delivery Only {#sec-14000-14370 omnilex-key=us-de-regs-official--title-16--14000-14370}

Emergency services must be rendered in an acute care hospital emergency room or in an acute care inpatient hospital. Labor and delivery only services must be rendered in an acute care hospital emergency room, an acute care inpatient hospital, or a birthing center. The DMAP defines an emergency as:

·

a sudden serious medical situation that is life threatening; or

·

a severe acute illness or accidental injury that demands immediate medical attention or surgical attention; and

·

without the treatment a person's life could be threatened or he or she could suffer serious long lasting disability.

Medically necessary physician (surgeon, pathologist, anesthesiologist, emergency room physician, internist, etc.) or midwife services rendered during an emergency service that meets the above criteria are covered. Ancillary services (lab, x-ray, pharmacy, etc.) rendered during an emergency service that meets the above criteria are also covered. Emergency ambulance services to transport these individuals to and from the services defined above are also covered.

Services not covered for aliens who are determined to be eligible for emergency services and labor and delivery only include but are not limited to:

·

any service delivered in a setting other than an acute care hospital emergency room or an acute care inpatient hospital. Exception: labor and delivery services may be rendered in a birthing center.

·

any service (such as pharmacy, transportation, office visit, lab or x-ray, home health) that precedes or is subsequent to a covered emergency service. Exception: ambulance transportation that is directly related to the emergency is covered.

·

organ transplants

·

long term care or rehabilitation care

·

routine prenatal and post partum care

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14380** Declaration of U.S. Citizenship and Satisfactory Immigration Status {#sec-14000-14380 omnilex-key=us-de-regs-official--title-16--14000-14380}

As a condition of eligibility under section 1137(d) of the Act, an applicant must sign a written declaration under penalty of perjury stating if he or she is a citizen or national of the U.S. or an alien in satisfactory immigration status (qualified alien or alien in lawful status). This declaration is obtained as part of the application for Medicaid. In the case of a child or incompetent applicant, an adult must sign on the applicant's behalf.

If the applicant is not a citizen or national of the United States, qualified alien, or an alien in lawful status, the declaration of citizenship or satisfactory immigration status and verification of such status is not required. If the applicant will not sign the declaration, he or she may be found eligible for coverage of emergency services and labor and delivery only.

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14390** Documentation of Citizenship and Identity or Alien Status {#sec-14000-14390 omnilex-key=us-de-regs-official--title-16--14000-14390}

Applicants must provide documentation of citizenship and identity, qualified alien status, or lawful alien status.

Exception: The following groups of individuals are not required to provide documentation of citizenship and identity:

a) Individuals receiving SSI

b) Individuals entitled to or enrolled in any part of Medicare

c) Individuals receiving Social Security Disability Insurance benefits

d) Individuals who are recipients of foster care maintenance or adoption assistance payments under Title IV-E of the Act

e) Individuals who are in foster care and who are assisted under Title IV-B of the Act

f) Deemed newborns – a child born in the U.S. to a woman who was eligible for and receiving Medicaid (including coverage of an alien for labor and delivery as emergency medical services) on the date of the child’s birth. This includes a retroactive determination of eligibility.

If the applicant will not provide evidence of alien status and does not allege qualified or lawful alien status, the applicant may be eligible for coverage of emergency services and labor and delivery only.

14390.1 Reasonable Opportunity to Provide Documentation of Citizenship and Identity or Alien Status

An applicant shall have a reasonable opportunity period of 90 days to obtain and provide proof of citizenship and identity, qualified alien status, or lawful alien status. The reasonable opportunity period begins on the date a written request for documentation is issued to the applicant.

Medicaid shall be approved to otherwise eligible applicants during the reasonable opportunity period. If the individual has not provided satisfactory documentation by the end of the reasonable opportunity period, eligibility will be terminated.

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14400** Acceptable Evidence of U. S. Citizenship and Identity {#sec-14000-14400 omnilex-key=us-de-regs-official--title-16--14000-14400}

Both citizenship AND identity can be verified by the Social Security Administration through the State Verification Exchange System (SVES). If verification cannot be obtained through SVES, verification of citizenship and identity must be obtained from original documents or certified copies from the issuing agency. Once documentation of citizenship and identity has been provided, it is not necessary to obtain documentation again.

The list below provides acceptable documentation for verifying citizenship and identity. There are four levels of verification listed in order of preference. If a higher level document is not available, a lower level may be used.

A. First level documentation of both citizenship AND identity

1. A U.S. passport. A U.S. passport does not have to be currently valid to be accepted as evidence of U.S. citizenship, as long as it was originally issued without limitation. Do not accept any passport as evidence of U.S. citizenship when it was issued with a limitation. However, such a passport may be used as proof of identity. Note: Spouses and children were sometimes included on one passport through 1980. The citizenship and identity of the included person can be established when one of these passports is presented. U.S. passports issued after 1980 show only one person.

2. A Certificate of Naturalization (DHS Forms N–550 or N–570)

3. A Certificate of U.S. Citizenship (DHS Forms N–560 or N–561)

B. Second level documentation of citizenship

1. A U.S. public birth certificate showing birth in one of the 50 States, the District of Columbia, Puerto Rico (if born on or after January 13, 1941), Guam (on or after April 10, 1899), the Virgin Islands of the U.S. (on or after January 17, 1917), American Samoa, Swain's Island, or the Northern Mariana Islands (after November 4, 1986 (NMI local time)).

2. A Certification of Report of Birth (DS–1350)

3. A Report of Birth Abroad of a U.S. Citizen (Form FS–240)

4. A Certification of birth issued by the Department of State (Form FS–545)

5. A U.S. Citizen I.D. card (I-197 or I-179)

6. A Northern Mariana Identification Card (I–873)

7. An American Indian Card (I–872)

8. A final adoption decree showing the child's name and U.S. place of birth. In situations where an adoption is not finalized and the State in which the child was born will not release a birth certificate prior to final adoption, a statement from a State approved adoption agency that shows the child's name and U.S. place of birth is acceptable. The adoption agency must state in the certification that the source of the place of birth information is an original birth certificate.

9. Evidence of U.S. Civil Service employment before June 1, 1976

10. U.S. Military Record showing a U.S. place of birth. (DD–214 or similar official document showing a U.S. place of birth)

11. A data verification with the Systematic Alien Verification for Entitlements (SAVE) Program for naturalized citizens.

12. Child Citizenship Act - Obtain documentary evidence that verifies that at any time on or after February 27, 2001, the following conditions have been met: (i) at least one parent of the child is a U.S. citizen by either birth or naturalization and this has been verified; (ii) the child is under the age of 18; (iii) the child is residing in the U.S. in the legal and physical custody of the U.S. citizen parent; (iv) the child was admitted to the U.S. for lawful permanent residence and this has been verified; and (v) if adopted, the child satisfies the requirements of section 101(b)(1) of the Immigration and Nationality Act (8 U.S.C. 1101(b)(1) pertaining to international adoptions (admission for lawful permanent residence as IR–3 or IR–4).

C. Third level documentation of citizenship

1. Extract of a hospital record on hospital letterhead established at the time of the person's birth that was created 5 years before the initial application date and that indicates a U.S. place of birth. For children under age 16, the document must have been created near the time of birth or 5 years before the date of application. Do not accept a souvenir “birth certificate” issued by the hospital.

2. Life, health, or other insurance record showing a U.S. place of birth that was created at least 5 years before the initial application date and that indicates a U.S. place of birth. For children under age 16, the document must have been created near the time of birth or 5 years before the date of application. Life or health insurance records may show biographical information for the person including place of birth and can be used to establish U.S. citizenship when it shows a U.S. place of birth.

3. Religious record recorded in the U.S. within 3 months of birth showing the birth occurred in the U.S. and showing either the date of the birth or the individual's age at the time the record was made. The record must be an official record recorded with the religious organization.

4. Early school record showing a U.S. place of birth. The school record must show the name of the child, the date of admission to the school, the date of birth, a U.S. place of birth, and the name(s) and place(s) of birth of the applicant's parents.

D. Fourth level documentation of citizenship

1. Federal or State census record showing U.S. citizenship or a U.S. place of birth. Census records from 1900 through 1950 contain certain citizenship information. The census record must also show the applicant's age.

2. One of the documents listed that shows a U.S. place of birth and was created at least 5 years before the application for Medicaid. For children under age 16, the document must have been created near the time of birth or 5 years before the date of application. This document must be one of the following and show a U.S. place of birth:

a) Seneca Indian tribal census record.

b) Bureau of Indian Affairs tribal census records of the Navajo Indians.

c) U.S. State Vital Statistics official notification of birth registration.

d) A delayed U.S. public birth record that is recorded more than 5 years after the person's birth.

e) Statement signed by the physician or midwife who was in attendance at the time of birth

f) The Roll of Alaska Natives maintained by the Bureau of Indian Affairs.

3. Institutional admission papers from a nursing facility, skilled care facility, or other institution created at least 5 years before the initial application date that indicates a U.S. place of birth. Admission papers generally show biographical information for the person including place of birth. The record can be used to establish U.S. citizenship when it shows a U.S. place of birth.

4. Medical (clinic, doctor, or hospital) record created at least 5 years before the initial application date that indicates a U.S. place of birth. For children under age 16, the document must have been created near the time of birth or 5 years before the date of application. Medical records generally show biographical information for the person including place of birth. The record can be used to establish U.S. citizenship when it shows a U.S. place of birth. (Note: An immunization record is not considered a medical record for purposes of establishing U.S. citizenship.)

5. Written affidavit. Affidavits should only be used in rare circumstances. If the documentation requirement needs to be met through affidavits, the following rules apply:

a) There must be at least two affidavits by two individuals who have personal knowledge of the event(s) establishing the applicant's or recipient's claim of citizenship.

b) At least one of the individuals making the affidavit cannot be related to the applicant or recipient. Neither of the two individuals can be the applicant or recipient.

c) The persons making the affidavits must be able to provide proof of their own citizenship and identity.

d) If the individual making the affidavit has information which explains why documentary evidence establishing the applicant's claim of citizenship does not exist or cannot be readily obtained, the affidavit should contain this information as well.

e) The applicant or representative must make a separate affidavit explaining why the evidence does not exist or cannot be obtained.

f) The affidavits must be signed under penalty of perjury and need not be notarized.

E. Documentation of identity.

1. Identity documents described in 8 CFR 274a.2(b)(1)(v)(B)(1). Exception: Do not accept a voter's registration card or Canadian driver's license as listed in 8 CFR 274a.2(b)(1)(v)(B)(1).

a) Driver's license issued by a State or Territory either with a photograph of the individual or other identifying information of the individual such as name, age, sex, race, height, weight, or eye color.

b) School identification card with a photograph of the individual.

c) U.S. military card or draft record.

d) Identification card issued by the Federal, State, or local government with the same information included on drivers' licenses.

e) Military dependent's identification card.

f) Certificate of Degree of Indian Blood, or other American Indian/Alaska Native Tribal document with a photograph or other personal identifying information relating to the individual such as age, weight, height, race, sex, and eye color.

g) U.S. Coast Guard Merchant Mariner card.

2. A cross match with Office of Vital Statistics.

3. Three or more documents that together reasonably corroborate the identity of an individual provided such documents have not been used to establish the individual's citizenship and the individual submitted second or third level evidence of citizenship. Such documents must at a minimum contain the individual's name, plus any additional information establishing the individual's identity. All documents used must contain consistent identifying information. These documents include employer identification cards, high school and college diplomas from accredited institutions (including general education and high school equivalency diplomas), marriage certificates, divorce decrees, and property deeds/titles.

F. Special identity rules for children

For children under age 16, a clinic, doctor, hospital, or school record may be accepted. School records include nursery or daycare records and report cards if verified with the issuing school. If none of the above documents in the preceding groups are available, an affidavit may be used. An affidavit is only acceptable if it is signed under penalty of perjury by a parent, guardian, or caretaker relative stating the date and place of the birth of the child and cannot be used if an affidavit for citizenship was provided. The affidavit is not required to be notarized. An affidavit for children under age 18 may be accepted when a school ID card or driver’s license is not available.

G. Special identity rules for individuals with disabilities in institutional care facilities

An affidavit signed under penalty of perjury by a residential care facility director or administrator on behalf of an institutionalized individual in the facility.

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14410** Acceptable Evidence of Qualified Alien Status {#sec-14000-14410 omnilex-key=us-de-regs-official--title-16--14000-14410}

Documentation of alien status is issued by the U.S. Citizenship and Immigration Services (USCIS) of the Department of Homeland Security. Older documents were issued by the Immigration and Naturalization Service (INS).

Acceptable documentation of qualified alien status is listed below. The card should show the date of admission or date of entry into the United States.

A. Lawful Permanent Residents

Form I-551, or for recent arrivals, a temporary I-551 stamp in a foreign passport or on Form I-94.

NOTE: USCIS has replaced Forms I-151, AR-3 and AR-3a. If a lawful permanent resident presents one of these old forms as evidence of status, contact USCIS using a G-845S and attach the old card.

B. Refugees

Form I-94 annotated with stamp showing entry as refugee under §207 of the Immigration and Naturalization Act (INA) and date of entry to the United States; Form I-688B annotated 274a.2(a)(3); I-766 annotated A3; or Form I-571. Refugees usually adjust to Lawful Permanent Resident status after 12 months in the U.S. However, for purposes of eligibility, the individual is still considered a refugee and it is important to check the coding on Form I-551 for codes RE-6, RE-7, RE-8, or RE-9.

C. Asylees

Form I-94 annotated with stamp showing grant of asylum under §208 of the INA; a grant letter from the Asylum Office of the USCIS; Form I-688B annotated 274a.12(a)(5); I-766 annotated A5; or an order of an Immigration Judge granting asylum. If the applicant provides a court order contact USCIS using a G-845S and attach a copy of the court order.

D. Alien who has had deportation withheld under §243(h) of the INA

Order of an Immigration Judge showing deportation withheld under §243(h) or §241(b)(3) and date of the grant; Form I-688B annotated 274a.12(a)(10); or I-766 annotated A10. If applicant provides a court order contact USCIS using G-845S and attach copy of court order.

E. Parolees

Form I-94 annotated with stamp showing grant of parole under §212(d)(5) of the INA and a date showing granting of parole for at least 1 year. Form I-688B annotated 274a.12(a)(4) or 274a.12(c)(11) or I-766 annotated A4 or C11 indicates status as a parolee but does not reflect the length of the parole period.

F. Conditional Entrant

Form I-94 annotated with stamp showing admission under §203(a)(7) of the INA, refugee-conditional entry; Forms I-688B annotated 274a.12(a)(3); or I-766 annotated A-3.

G. Evidence of Honorable Discharge or Active Duty Status

Discharge - a copy of the veteran's discharge papers issued by the branch of service in which the applicant was a member. (Department of Defense Form 214)

Active Duty Military - a copy of the applicant's current orders showing the individual is on full-time duty in the U.S. Army, Navy, Air Force, Marine Corps, or Coast Guard or an active military identification card, DD Form 2. Full time National Guard duty is excluded.

H. Cuban and Haitian entrants

I-551 annotated CH6, CNP, CU6, CU7; I-688B annotated 274a.12(a)(4); I-94 annotated 212(d)(5)

I. Amerasian

I-94 annotated AM1, AM2, AM3; I-551 annotated AM1, AM2, AM3.

J. Battered Immigrant

In order to be a qualified alien based on battery or extreme cruelty, the alien must meet the following requirements:

1. the alien must not now be residing in the same household as the individual responsible for the battery or extreme cruelty

2. the alien or the alien’s child has been battered or subjected to extreme cruelty in the U.S. by a spouse or parent of the alien, or by a member of the spouse’s or parent’s family residing in the same household as the alien, but only if the spouse or parent consents to or acquiesces in such battery or cruelty and, in the case of a battered child, the alien did not actively participate in the battery or cruelty

3. there is substantial connection between the battery or extreme cruelty and the need for the public benefit sought. There is a substantial connection under any one or more of the following circumstances:

a) Where the benefits are needed to enable the alien and/or the alien’s child to become self-sufficient following separation from the abuser;

b) Where the benefits are needed to enable the alien and/or the alien’s child to escape the abuser and/or the community in which the abuser lives, or to ensure the safety of the alien and/or his or her child from the abuser;

c) Where the benefits are needed due to a loss of financial support resulting from the alien’s and/or his or her child’s separation from the abuser;

d) Where the benefits are needed because the battery or cruelty, separation from the abuser, or work absence or lower job performance resulting from the battery or extreme cruelty or from legal proceedings relating to the battery or cruelty (such as child support or child custody disputes) cause the alien and/or the alien’s child to lose his or her job or require the alien and/or the alien’s child to leave his or her job for safety reasons;

e) Where the benefits are needed because the alien or his or her child requires medical attention or mental health counseling, or has become disabled, as a result of the battery or cruelty;

f) Where the benefits are needed because the loss of a dwelling or source of income or fear of the abuser following separation from the abuser jeopardizes the alien’s ability to care for his or her children (e.g. inability to house, feed, or clothe children or to put children into day care for fear of being found by the batterer);

g) Where the benefits are needed to alleviate nutritional risk or need resulting from the abuse or following separation from the abuser;

h) Where the benefits are needed to provide medical care during an unwanted pregnancy resulting from the abuser’s sexual assault or abuse of or relationship with the alien or his or her child; and/or to care for any resulting children; or

i) where medical coverage and/or health care services are needed to replace medical coverage or health care services the applicant or child had when living with the abuser.

4. the alien or alien’s child must have a petition approved by or pending with USCIS under one of several subsections of the INA that sets forth a prima facie case for the status.

K. American Indian born in Canada or Mexico under section 289 of the INA or member of Indian tribe under section 4(e) of the Indian Self-Determination and Education Assistance Act

Form I-551 with the code S13; unexpired temporary I-551 stamp with code S13 in a Canadian passport or on Form I-94; satisfactory evidence of birth in Canada and a document that indicates the percentage of American Indian blood in the form of a birth certificate issued by the Canadian reservation or a record issued by the tribe; a membership card or other tribal document showing membership in the tribe that is on the list of recognized Indian tribes published annually by the Bureau of Indian Affairs in the Federal Register.

L. Victims of Trafficking

Form I-797 indicating Class T-1 Visa, T-2 (spouse), T-3 (child), T-4 (parent) or T-5 (unmarried sibling under age 18); letter of certification from the Office of Refugee Resettlement (ORR). Call the trafficking verification line at (202) 401-5510 to confirm the validity of the certification letter or similar letter for children and to notify ORR of the benefits for which the individual has applied.

M. Iraqi and Afghan special immigrants

Iraqi passport with an immigrant visa stamp SI1, SI2 (spouse), SI3 (unmarried child under age 21); an immigrant visa stamp SQ1, SQ2 (spouse), SQ3 (unmarried child under age 21); I-551 showing Iraqi nationality (or an Iraqi passport) with code S16 or SQ6, code S17 or SQ7 (spouse), code S19 or SQ9 (unmarried child under age 21).

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14420** Verification of Alien Status {#sec-14000-14420 omnilex-key=us-de-regs-official--title-16--14000-14420}

The Systematic Alien Verification for Entitlements (SAVE) is a program established by USCIS that provides a process to verify the immigration status of aliens who apply for benefits. The documents provided by an alien applicant as verification of immigration status must be authenticated by using SAVE.

Staff will institute primary verification to USCIS through the form "Record of Contact with ASVI Data Base" (SAVE-1). ASVI is the acronym for Alien Status Verification Index. A clear copy of the immigration document must be attached to the SAVE-1 form. If the response verifies alien status, the eligibility determination is completed using the information provided by USCIS.

If the response states institute secondary verification, staff will complete Form G-845 and attach a copy of the immigration document.

An alien registration number is required for both primary and secondary verifications. If the applicant provides an alien registration number but does not have the immigration document, complete Form G-845 including the alien registration number. If an applicant provides a receipt indicating that he or she has applied to USCIS for a replacement document, complete Form G-845 and attach a copy of the receipt.

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14500** Criteria Affecting Specific Groups {#sec-14000-14500 omnilex-key=us-de-regs-official--title-16--14000-14500}

Certain eligibility groups have requirements that include age, household composition/filing unit, and medical eligibility/disability.

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14510** Age {#sec-14000-14510 omnilex-key=us-de-regs-official--title-16--14000-14510}

Some eligibility groups have certain age requirements. Refer to specific eligibility group for information specific to that program.

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14520** Household Composition/Filing Unit {#sec-14000-14520 omnilex-key=us-de-regs-official--title-16--14000-14520}

Generally, related applicants, their needs, income and resources are grouped together when a family applies for Medicaid. The requirements are specific to each eligibility group.

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14530** Medical Eligibility/Disability {#sec-14000-14530 omnilex-key=us-de-regs-official--title-16--14000-14530}

Certain eligibility groups require a medical professional to certify that an applicant meets the specific program definition of medical need or disability. Examples are:

·

pregnant women must have proof of pregnancy

·

children with a disability must meet disability and level of care requirements

·

long term care applicants must meet level of care requirements

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14540** Estate Recovery Protections {#sec-14000-14540 omnilex-key=us-de-regs-official--title-16--14000-14540}

Effective with dates of service on or after January 1, 2010, medical assistance for Medicare cost-sharing is protected from estate recovery for certain categories of individuals who, collectively, are known as dual eligibles.

The following categories of individuals are protected from estate recovery of Medicare cost-sharing:

a) Qualified Medicare Beneficiaries

b) Specified Low Income Medicare Beneficiaries

c) Qualifying Individuals

d) Qualified and Disabled Working Individuals

e) Qualified Medicare Beneficiaries with full Medicaid

f) Specified Low Income Medicare Beneficiaries with full Medicaid

Medicare cost-sharing includes payments of Part A and Part B premiums, deductibles, coinsurance, and copayments. The date of service for premiums is the date DMMA paid the premium. The date of service for deductibles, coinsurance, and copayments is the date the request for payment is received by DMMA. The protection from estate recovery for Medicare cost sharing applies to mandatory and optional services under the State plan including nursing facility, home and community-based services, and related prescription drugs and hospital services.

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14600** Third-Party Liability {#sec-14000-14600 omnilex-key=us-de-regs-official--title-16--14000-14600}

Some Medicaid recipients are covered by other medical insurance plans. Examples of other resources are Medicare, employment related health insurance, Union Health & Welfare Funds, national Blue Cross and Blue Shield plans, Military Health Insurance For Active Duty, Retired Military, and their dependents, workmen's compensation, and no-fault automobile coverage. When a recipient receives payment from an insurance carrier, court settlement, etc. for any medical services paid by Medicaid, the recipient is obligated to reimburse the program for those related services. All such cases must be referred to the Third Party Liability Unit at the Medicaid State Office.

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14610** Assignment Of Rights To Benefits {#sec-14000-14610 omnilex-key=us-de-regs-official--title-16--14000-14610}

As a condition of eligibility, each legally able applicant and recipient must:

A. assign his or her rights and the rights of any other eligible individuals for whom the individual has the legal authority under State laws to assign such rights, to medical support or other third party payments to the agency. (for example, a parent assigns the rights of a child);

B. cooperate in establishing paternity and obtaining medical support unless there is a finding of good cause (pregnant and post partum women do not have to meet this requirement); and

C. cooperate, absent good cause, in identifying and providing information needed to pursue third parties who may be liable to pay for medical services covered by Medicaid.

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14620** Rights Assigned {#sec-14000-14620 omnilex-key=us-de-regs-official--title-16--14000-14620}

The applicant or recipient must make a written assignment assigning his or her rights to any medical support available under an order of a court or an administrative agency. He or she must also assign to Medicaid any third party payments for medical care and payments for any other eligible individual for whom he or she has the legal authority under State law to make an assignment.

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14630** Cooperation In Establishing Paternity And Obtaining Support {#sec-14000-14630 omnilex-key=us-de-regs-official--title-16--14000-14630}

The individual is required to cooperate in establishing the paternity of a child born out of wedlock for whom the individual can legally assign rights and in obtaining medical care support and medical care payments for himself/herself, as well as for any other person for whom the individual can legally assign rights. Exception: Pregnant and Post Partum women do not have to cooperate in establishing paternity and obtaining medical support.

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14640** Identifying and Providing Third Party Information {#sec-14000-14640 omnilex-key=us-de-regs-official--title-16--14000-14640}

The individual is required to cooperate in identifying and providing information to assist the state in pursuing any third party which may be liable to pay for care and services available under the state plan.

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14650** Good Cause For Noncooperation {#sec-14000-14650 omnilex-key=us-de-regs-official--title-16--14000-14650}

The requirements for cooperation may be waived if there is a determination of good cause. The determination of whether good cause exists is based on the factors established by the TANF/AFDC child support enforcement program at 45 CFR 232.40 - 232.49. Use similar procedures to make a determination of good cause for individuals other than a child excluding those applicable only to children.

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14660** Denial Or Termination Of Eligibility {#sec-14000-14660 omnilex-key=us-de-regs-official--title-16--14000-14660}

Individuals who fail to meet the assignment provisions including assignment of rights to benefits and cooperation must be denied Medicaid eligibility or have eligibility terminated if already receiving Medicaid. This includes individuals who refuse to assign his or her own rights or those of any other individual for whom he or she can legally make an assignment. Pregnant and postpartum women do not have to cooperate in establishing paternity and obtaining medical support.

Medicaid must be provided to any individual who cannot legally assign his or her own rights and is otherwise eligible for Medicaid, when the person who has the legal authority refuses to assign the eligible individual’s rights. For example, if a mother refuses to assign benefits for herself and her children, only the mother becomes ineligible for Medicaid. The children remain eligible. However, if a mother with a newborn refuses to assign rights or to cooperate, both the mother and the newborn are ineligible, since the newborn’s eligibility is dependent upon the mother’s eligibility. An application must be filed on behalf of the newborn to establish eligibility on his or her own behalf as a child.

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14670** Payor Of Last Resort {#sec-14000-14670 omnilex-key=us-de-regs-official--title-16--14000-14670}

Because other insurance is commonly available, the Federal Government as a way of saving taxpayers’ monies, has required by law THAT Medicaid be a payor of last resort.

Because Medicaid is a payor of last resort, it is especially important to screen patients for the existence of other health insurance coverage. Keep in mind that other insurance will usually pay more for the incurred charges than Medicaid, hence it is beneficial to always inquire thoroughly.

Although the Medicaid Program attempts to collect this information when a recipient becomes eligible, additional efforts in this area at redetermination should not only increase provider's payments, but decrease the expenditures of taxpayers' monies.

The usual elements that a financial social worker will need to obtain are: name, address, policy number of the insurance company, as well as the policy holders name, address, Social Security number, employer number and effective dates of coverage.

Medicaid will only pay a designated amount (which is usually lower than the amount billed) no matter what the provider charges. This payment has to be accepted in full by the provider and the client cannot be billed for any balance. Providers agree to accept our payment as payment in full when they sign a contract to enroll in the Medicaid Program. Any violations should be referred to the Surveillance and Utilization Review unit.

Clients can report loss of coverage or a change in benefit directly to the TPL unit via phone call. This unit also investigates and verifies potential coverage for Medicaid recipients.

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14680** Third Party Liability Guide {#sec-14000-14680 omnilex-key=us-de-regs-official--title-16--14000-14680}

To aid in turning up other possible sources of coverage, the following guide has been prepared.

IF YOU FIND:

THEN A CASE MEMBER MAY BE ELIGIBLE FOR:

Any case member is over 65 or blind or disabled

Medicare or Medicare Supplemental policies

A recipient, absent parent, step-parent, dependent child, new spouse or an absent parent, or anyone else who is legally or voluntarily responsible for a case member is EMPLOYED or a UNION MEMBER

Employment related health insurance

A case member, spouse of a case member, absent parent, or step-parent is ACTIVE DUTY MILITARY or a VETERAN

Military Health Insurance For Active Duty, Retired Military, and their dependents, VA Health coverage

Any case member has been in an accident or otherwise accidentally injured: INJURY/TRAUMA/

ACCIDENT

Workman’s compensation, homeowners insurance, automobile insurance, liability insurance

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14700** Assets {#sec-14000-14700 omnilex-key=us-de-regs-official--title-16--14000-14700}

There are different types of income and resources which are counted and budgeted according to a specific Medicaid program’s criteria.

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14710** Income {#sec-14000-14710 omnilex-key=us-de-regs-official--title-16--14000-14710}

Income is any payment from any source whether in money, goods or services; whether recurring or on a one-time basis. Gross income, net income, disregarded income, excluded income, earned and unearned income are defined in the policy of each specific program.

Income eligibility limits vary from program to program.

For each Medicaid eligibility group and for the Delaware Healthy Children Program, all wages paid by the U.S. Census Bureau for temporary employment related to Decennial Census activities are excluded in years in which there is a federal census.

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14720** Resources {#sec-14000-14720 omnilex-key=us-de-regs-official--title-16--14000-14720}

Resources vary from program to program. See specific program for limits. The term "resources" means things a person owns. It includes real estate and personal property, such as household goods, savings and checking accounts, stocks and bonds, life insurance, and other assets that can be applied to meeting a person's needs for food, clothing, or shelter.

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14730** Accepting Other Benefits {#sec-14000-14730 omnilex-key=us-de-regs-official--title-16--14000-14730}

As a condition of eligibility, applicants/recipients are required to take all necessary steps to obtain any income or resource benefits. Examples are annuities, pensions, retirement, disability and veteran's benefits to which they are entitled.

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14800** Verifications of Factors of Eligibility {#sec-14000-14800 omnilex-key=us-de-regs-official--title-16--14000-14800}

Regulatory Statute

42 CFR 435.948

42 CFR 435.949

42 CFR 435.952

42 CFR 435.956

Attestation will be accepted for most factors of eligibility at application, renewal, and for a change in circumstances. Attestation will be accepted by the individual; an adult who is in the applicant’s household; an authorized representative; or if the individual is a minor or incapacitated someone acting responsibly for the individual. Certain factors of eligibility will be verified post-enrollment, post-renewal, and after a redetermination of eligibility due to a change in circumstances.

Verification will be obtained electronically using the Federal Data Services Hub (FDSH) and other electronic data sources. The FDSH is a service that enables access to multiple data bases via a single electronic transaction. Data will be available from the Social Security Administration (SSA), Department of Homeland Security (DHS), Internal Revenue Service (IRS), and Equifax Workforce Solutions (also known as TALX). TALX is a contracted service that verifies earned income as reported by employers. The agency will not be obtaining IRS data.

Other electronic data sources include the following:

Attestation will be accepted without post-enrollment verification for the following factors of eligibility:

Attestation will be accepted with post-enrollment verification for the following factors of eligibility:

Attestation will not be accepted and must be verified via the FDSH for the following factors of eligibility:

If citizenship and immigration status cannot be verified via the FDSH, the individual will be provided with a 90-day reasonable opportunity period to submit other documentation and may be found eligible during that time period. The reasonable opportunity period will be extended beyond 90 days if the individual is making a good faith effort to obtain the documentation.

Verification of SSN will be in accordance with Sections 14105-14105.1.

Individuals will not be required to provide additional information or documentation unless the information cannot be obtained electronically or is not reasonably compatible with the attested information.

Reasonably compatible means that the information provided by an electronic data source is generally consistent with the information reported by the applicant or beneficiary. Income verification obtained through an electronic data source shall be considered reasonably compatible when:

When the difference between the attestation of income and the electronic verification is more than 25%, a reasonable explanation will be sought from the applicant or beneficiary. A reasonable explanation may include, but is not limited to, a loss of employment or reduced hours of employment. If both the reported income and the data source indicate that the income is below the applicable standard then no additional information is needed.

Post-enrollment verification will be completed in accordance with the agency’s verification plan approved by the Centers for Medicare & Medicaid Services (CMS). Post-enrollment verification of income and Medicare will be completed within 30 days of the date of enrollment. When additional information is needed to complete the eligibility determination, the agency will request such additional information from the individual. The individual will be provided 30 days to respond to the request for additional information. If the additional information requested is not provided, eligibility will be terminated unless the child is in a continuous eligibility period. See Section 14810.2 Continuous Eligibility for Children in Medicaid.

Exceptions to the verification requirements will be permitted on a case-by-case basis when documentation does not exist or is not reasonably available, such as for individuals who are homeless or have experienced domestic violence or a natural disaster. The exception does not apply to the verification requirements for citizenship and immigration status.

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14810** Continuous Eligibility {#sec-14000-14810 omnilex-key=us-de-regs-official--title-16--14000-14810}

Continuous eligibility provides coverage for a predetermined period of time, regardless of changes in circumstances, with certain exceptions.

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14810.1** Continuous Eligibility for Pregnant Women {#sec-14000-14810.1 omnilex-key=us-de-regs-official--title-16--14000-14810.1}

42 CFR 435.116

42 CFR 435.170

Once a pregnant woman is determined eligible, she remains eligible throughout the pregnancy and the postpartum period regardless of changes in circumstances or eligibility category she is currently enrolled in. Refer to DSSM 15200 for full details around Continuous Eligibility for Pregnant Women.

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14810.2** Continuous Eligibility for Children Enrolled in Medicaid {#sec-14000-14810.2 omnilex-key=us-de-regs-official--title-16--14000-14810.2}

42 CFR 435.926

Effective January 1, 2024, all children under the age of 19 who are enrolled in Medicaid under any eligibility program shall have 12 months of continuous eligibility. The continuous eligibility period begins:

A child's eligibility may not be terminated during a continuous eligibility period, regardless of any change in circumstances, unless:

(1) The child attains age 19, unless the child is in a 12-month postpartum period;

(2) The child or child's representative requests a voluntary termination of eligibility;

(3) The child ceases to be a resident of the State;

(4) The agency determines that eligibility was erroneously granted at the most recent determination, or renewal of eligibility because of agency error or fraud, abuse, or perjury attributed to the child or the child's representative; or

(5) The child dies.

Children who have been determined eligible based on self-attested information are entitled to the 12-month continuous eligibility period. Coverage may not be terminated for such children during a continuously eligible period if, in conducting post-enrollment verification, the state obtains information that indicates that the child does not meet all the eligibility requirements unless the information indicates that one of the limited exceptions to continuous eligibility above applies.

If the self-attested information indicates that the child is eligible, the state is not considered to have made an erroneous determination, even if there is an inconsistency between the attested information and information subsequently obtained from family or electronic data sources after enrollment. The receipt of information is considered a change in circumstance. See Section 14800 Verifications of Factors of Eligibility.

Children whose citizenship or satisfactory immigration status is not verified have not been determined eligible. Continuous Eligibility does not apply to children who are receiving benefits under a reasonable opportunity to provide (ROP) period if the child's status cannot be verified. See Section 14390.1 Reasonable Opportunity to Provide Documentation of Citizenship and Identity or Alien Status.

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14820** Changes in Circumstances {#sec-14000-14820 omnilex-key=us-de-regs-official--title-16--14000-14820}

At the time of application and renewal, individuals will be informed that they are responsible for notifying the agency about changes in circumstances that may affect eligibility. Changes may be reported via the ASSIST Self Service website, by telephone, via mail, in person, and through other commonly available electronic means. Eligibility will be redetermined promptly between regularly scheduled renewals when information about a change in circumstance may affect eligibility unless the member is in a continuous eligibility period. See Section 14810.1 How Changes in Circumstances affect Continuous Eligibility.

If the agency has information about anticipated changes in a beneficiary’s circumstances that may affect their eligibility, the agency will redetermine eligibility at the appropriate time based on such changes.

Failure to report changes that may affect eligibility may result in an overpayment being filed or legal action taken to recover funds expended during periods of ineligibility.

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14820.1** How Changes in Circumstances affect Continuous Eligibility {#sec-14000-14820.1 omnilex-key=us-de-regs-official--title-16--14000-14820.1}

When a beneficiary is in a continuous eligibility period, coverage may not be terminated due to a change in circumstance, reported by the family or detected through a data match, prior to the regularly scheduled renewal, unless the change of circumstance is an allowable exception.

See Section 14810 Continuous Eligibility.

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14830** State To State Transfer Of Medicaid Eligibility {#sec-14000-14830 omnilex-key=us-de-regs-official--title-16--14000-14830}

Medicaid benefits do not automatically transfer when a Medicaid client moves from one state to another. The Medicaid client must cancel Medicaid in one state and call the new state to establish coverage.

In the case of an individual who has moved to Delaware from another State, the individual is no longer a resident of the first State. The individual is ineligible in that State. However, the case may not be closed yet due to administrative process.

We must not wait for the case to be closed in the old State of residence in order to open the Medicaid case here in Delaware (the new State of residence) provided the individual has been found eligible here. The fact that a case is open in another State is not sufficient reason to deny or delay an eligibility decision if the individual has established Delaware residency and is otherwise eligible.

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14840** Confidentiality {#sec-14000-14840 omnilex-key=us-de-regs-official--title-16--14000-14840}

Section 1902(a)(7) of the Social Security Act and 42 CFR Subpart F require Medicaid agencies to provide safeguards that restrict the use or disclosure of information about applicants and recipients to purposes directly connected with the administration of the Medicaid Program.

Purposes directly related to administration of the Medicaid Program include establishing eligibility, providing services for recipients, determining the amount of medical assistance, and conducting or assisting an investigation, prosecution, or civil or criminal proceeding related to the administration of the program.

At a minimum, the types of information about applicants and recipients that must be safeguarded and not released without consent include:

a. Names and addresses;

b. Medical services provided;

c. Social and economic conditions or circumstances;

d. Agency evaluation of personal information;

e. Medical data, including diagnosis and past history of disease or disability;

f. Information received for verifying income eligibility and amount of medical assistance payments; and

g. Information about third party liability.

See Administrative Notice:

A-14-98 Subpoenas for Public Assistance Records

14840.1 Release Of Information To Medicaid Providers

Medicaid providers have a contractual obligation to safeguard information about Medicaid recipients. Providers may have access to certain eligibility information if they can provide:

·

a Medicaid identification number (MCI)

or

·

two of the following identifying factors: individual's full name, date of birth, Social Security number;

AND

the date of service.

Providers who supply the above identifying factors may be given the following information:

a. correct spelling of the recipient's name;

b. MCI number;

c. date of birth;

d. an indication whether the individual is eligible for the date of service given or for a range of dates given. Providers may not be given all periods of eligibility;

e. third party liability information including policy number and type of coverage (for Medicare, only a yes/no indicator for Parts A and B may be provided);

f. prior authorization requirements;

g. restricted coverage.

NOTE: Transportation providers may be given the address and phone number of the recipient because this information is necessary to provide the service.

14840.2 Release Of Information To Interagencies

At the time of application, individuals are informed that all eligibility information is confidential and disclosure without written permission of the individual is limited. Medicaid has the authority to responsibly share information concerning applicants and recipients with:

a. other DHSS employees;

b. other Federal or federally assisted programs that provide assistance to individuals on the basis of need (SSI, HUD);

c. contracted service providers (DCIS and HCBS contractors);

d. consultants (Pre-Admission Screening Annual Resident Review or PASARR, physician consultant);

e. members of multidisciplinary teams providing direct services to the clients (DDDS teams composed of nurse, social worker, and psychologist); and

f. persons officially charged with administrative audit or program evaluation (Independent Professional Review or IPR , Peer Review Organization or PRO).

14840.3 Release Of Information For Legal Requests And An Emergency Situation

Information may be released to comply with a subpoena or other valid court order and in emergency situations when necessary to protect or warn others of imminent threats to their safety. In these circumstances, the case record will be documented with the reason for the disclosure and written notification of the disclosure will be sent to the client's last known address.

14840.4 Release Of Information To Others

Medicaid must obtain specific written permission from the individual before releasing information to other persons or sources.

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14850** Medical Assistance Cards {#sec-14000-14850 omnilex-key=us-de-regs-official--title-16--14000-14850}

The Medical Assistance Card is the instrument that verifies an individual’s eligibility for benefits. The card is renewed each month and is valid only for time period specified on the card. Refer to the Delaware Medical Assistance Provider Manual for more information about Medical Assistance Cards.

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14900** Enrollment In Managed Care {#sec-14000-14900 omnilex-key=us-de-regs-official--title-16--14000-14900}

On May 17, 1995, Delaware received approval from the Health Care Financing Administration (HCFA) (on June 14, 2001, HCFA was renamed Centers for Medicare and Medicaid Services [CMS]) for a Section 1115 Demonstration Waiver that is known as the Diamond State Health Plan. The basic idea behind this initiative is to use managed care principles and a strong quality assurance program to revamp the way health care is delivered to Delaware's most vulnerable populations. The Diamond State Health Plan is designed to provide a basic set of health care benefits to current Medicaid beneficiaries as well as uninsured individuals in Delaware who have income at or below 100% of the Federal Poverty Level (FPL). The demonstration waiver will mainstream certain Medicaid recipients into managed care to increase and improve access to medical service while improving cost effectiveness and slowing the rate of growth in health care costs.

Program Expansions

Effective July 1, 2002, a State operated managed care organization, Diamond State Partners, was implemented. Individuals may enroll in either the Diamond State Health Plan or Diamond State Partners

Effective April 1, 2012, the Diamond State Health Plan is expanded to include Long Term Care Medicaid and other full-benefit dual eligibles. This Long Term Care Managed Care Program is called Diamond State Health Plan Plus. Long Term Care Medicaid recipients and other full-benefit dual eligibles must enroll in Diamond State Health Plan Plus.

Managed Care Eligibility

The majority of the Medicaid population receiving Medicaid services will be enrolled into the Diamond State Health Plan, Diamond State Health Plan Plus, or Diamond State Partners. The following individuals cannot enroll in Diamond State Health Plan, Diamond State Health Plan Plus, or Diamond State Partners:

a. Individuals entitled to or eligible for a Medicare Savings Program (QMB, SLMB);

b. Individuals residing in an intermediate care facility for the developmentally disabled (ICF/MR);

c. Individuals covered under the Developmentally Disabled waiver program;

d. Individuals that choose to participate in the Program of All-inclusive Care for the Elderly (PACE);

e. Non lawful and non qualified non citizens (aliens);

f. Individuals eligible under the Breast and Cervical Cancer Treatment Group;

g. Presumptively eligible pregnant women;

h. Individuals in need of only the 30-Day Acute Care Hospital program.

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14910** Restricted Recipients {#sec-14000-14910 omnilex-key=us-de-regs-official--title-16--14000-14910}

Certain recipients who are exempt from the Diamond State Health Plan are restricted or locked-in when it has been determined that they are engaged in abusive or fraudulent practices such as overutilization of emergency room services or prescription drugs, lending a Medical Assistance card to an unauthorized person, etc. In general, restriction means that fee for service payments are limited to one primary physician and one primary pharmacy. Women are also permitted one obstetrician/gynecologist. Upon referral from the primary physician, any recipient with a special medical condition is permitted to have a specialist as an additional caretaker. If the restricted recipient visits other doctors or has prescriptions filled at other pharmacies, the Delaware Medical Assistance Program will not pay for these unauthorized claims and the recipient can be held responsible for such claims. Refer to the Delaware Medical Assistance Provider Manual for more information about restricted recipients.

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14920** Retroactive Coverage {#sec-14000-14920 omnilex-key=us-de-regs-official--title-16--14000-14920}

42 CFR 435.915

The agency must make eligibility for Medicaid effective no later than the third month before the month of application if the individual:

Received Medicaid services, at any time during that period, of a type covered under the plan; and

Would have been eligible for Medicaid in one of the below retroactive eligibility groups at the time the individual received the services if the individual had applied (or someone had applied on their behalf) regardless of whether the individual is alive when application for Medicaid is made; and

Individuals eligible under the Delaware Healthy Children's Program (DHCP) are not eligible for retroactive Medicaid.

Effective April 1, 2012, those that may be found eligible for retroactive Medicaid coverage, if general financial and technical eligibility requirements are met, include:

a. Individuals entitled to or eligible for 1 of the following Medicare Savings Programs (excludes QMB):

i. Specified Low Income Medicare Beneficiaries (SLMB)

ii. Qualifying Individuals (QI)

iii. Qualified and Disabled Working Individuals (QDWI)

b. Individuals residing in a nursing facility

c. Individuals residing in an intermediate care facility for individuals with intellectual disabilities (ICF/IID) or for individuals with mental disease (ICF/IMD)

d. Individuals in need of only the 30-day Acute Care Hospital Program (in no case should the effective date be earlier than the first day of hospitalization)

e. Women eligible under the Breast and Cervical Cancer Treatment Group

f. Individuals eligible under the Medicaid for Worker’s with Disabilities Group (provided premium requirements are met)

Effective August 1, 2019, the groups that may be found eligible for retroactive Medicaid, if general financial and technical eligibility requirements are met, was expanded to coverage include:

a. Pregnant and Postpartum Women

b. Infants under age 1

c. Individuals under the age of 19

Effective January 1, 2025, the groups that may be found eligible for retroactive Medicaid coverage, if general financial and technical eligibility requirements are met, was expanded to all eligible DSHP and DSHP-Plus Medicaid participants, with some exceptions, as described in DSSM 14920.1 Retroactive Coverage Limitations.

14920.1 Retroactive Coverage Limitations

Effective January 1, 2024, retroactive medical coverage is potentially available, if general financial and technical eligibility requirements are met, for all Medicaid individuals enrolled under the Diamond State Health Plan (DSHP) and Diamond State Health Plan Plus (DSHP-Plus).

Individuals eligible under the Delaware Healthy Children's Program (DHCP) are not eligible for retroactive Medicaid.

Individuals in the following programs are excluded from DSHP and DSHP-Plus, but may be found eligible for retroactive Medicaid coverage, if general financial and technical eligibility requirements are met.

a. Individuals entitled to the following Medicare Savings Programs

i. Specified Low Income Medicare Beneficiaries (SLMB)

ii. Qualifying Individuals (QI)

iii. Qualified and Disabled Working Individuals (QDWI)

b. Individuals residing in an intermediate care facility for individuals with intellectual disabilities (ICF/IID) or for individuals with mental disease (ICF/IMD)

c. Individuals in need of only the 30-Day Acute Care Hospital Program

d. Individuals eligible under the Breast and Cervical Cancer Treatment Group.

e. Individuals eligible for emergency, labor, and delivery coverage only.

f. Incarcerated Medicaid members.

All other individuals in programs excluded from DSHP and DSHP-Plus are not eligible for retroactive Medicaid Coverage. These include, but may not be limited to, individuals enrolled in the following programs:

a. The following Medicare Savings Program - Qualified Medicare Beneficiary.

b. The Chronic Renal Disease Program.

c. The Delaware Prescription Assistance Program.

d. The Delaware Cancer Treatment Program.

e. The Part C Program.

f. The VFC Immunization Program.

See 14920.1 Retroactive Coverage Limitations - History

14920.2 Retroactive Coverage Of Medical Bills

Individuals or families who apply for Medicaid and who may be eligible for Diamond State Health Plan or the Diamond State Health Plan Plus may be eligible for retroactive Medicaid coverage of any unpaid medical bills incurred in any of the three months prior to the month in which they applied. However, certain requirements must be met in order for these bills to be paid under Medicaid.

a. The client must have been eligible in all respects for Medicaid in one of the retroactive eligibility categories in the month(s) that the medical services were received (including Delaware residency).

b. The medical bill must be for a service covered by Medicaid.

c. The client did not have any third party coverage that would have been responsible for paying the bill.

d. The medical service must have been given by a provider who was a participant in the Delaware Medicaid program at the time of service. If the provider was not enrolled at the time of the service, the provider may enroll retroactively (up to 12 months).

14920.3 Retroactive Coverage Time Limits

There is no time limitation on requests for retroactive coverage. They may be processed at any time.

14920.4 Retroactive Application Process

Requests for retroactive Medicaid are received in various ways as described below:

a. Applicants indicate on the application that they have unpaid medical bills in the three months prior to the month of application.

b. Many requests are received over the telephone from clients who have an unpaid bill.

c. The Medicaid units receive lists from various medical providers such as Division of Public Health, and the school districts requesting assistance with the resolution of an unpaid bill for a Medicaid client.

d. The SSI Medicaid Unit receives data from the Social Security Administration via the SDX regarding individuals who need retroactive coverage.

14920.5 Retroactive Eligibility Determination

If the individual is determined to be eligible for retroactive coverage, the worker must confirm that the date of service of the individual's medical bill(s) falls within the 3 months prior to the month of application and that the individual meets the financial, technical, and medical (if applicable) eligibility requirements under Medicaid in 1 of the programs eligible for retroactive coverage during the retroactive period. Verify income and resources, as applicable in accordance with DSSM 14800.

Obtain information about third party liability information and forward to the TPL Unit.

A notice of Retroactive Medicaid Approval or Denial will be used to inform the client of the agency's disposition of the request for retroactive coverage. The client should be aware that even those bills submitted for payment may not be reimbursed by Medicaid (i.e., service not covered by Medicaid, non-participating provider, etc.).

14920.6 Retroactive Eligibility For Newborns

A baby born to a woman eligible for and receiving Medicaid on the date of the child's birth is deemed to have filed an application. Also, a mother can apply after a child is born and we will determine her eligibility for 3 month retroactive coverage. If the mother is determined retroactively eligible during her pregnancy or post-partum period, the infant is deemed eligible at birth and remains eligible for 1 year.

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14930** Medigap Policies {#sec-14000-14930 omnilex-key=us-de-regs-official--title-16--14000-14930}

Section 4354 of OBRA 1990 amends Section 1882 of the Social Security Act and imposes statutory limitations on the sale of Medicare supplemental policies (known as Medigap) to Medicare beneficiaries who are also eligible for Medicaid. The provisions apply to policies sold by insurers after 11/5/91 and to individuals who became entitled to Medicaid after that date. It is unlawful for an insurer to sell or issue any health insurance policy (other than an employer group policy) that duplicates Medicare, Medicaid or other health benefits to which the individual is entitled.

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14940** Health Insurance Portability And Accountability Act (HIPAA) Certificates {#sec-14000-14940 omnilex-key=us-de-regs-official--title-16--14000-14940}

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) is intended to guarantee the availability of health insurance coverage for employees and individuals and for limiting the use of preexisting condition restrictions. The law includes portability provisions intended to help ensure health care coverage for employees who move from one job to another. Before this law was passed, changing jobs could result in a temporary loss of comprehensive health coverage during the time it took to meet preexisting condition limitations.

HIPAA requires group health plans and health insurance issuers offering group health insurance coverage to reduce any preexisting condition limitation time period by the length of qualifying prior coverage an individual has for that condition. Qualifying prior coverage includes coverage under a group health plan, an individual health plan, Medicare, or Medicaid. The concept behind qualifying prior coverage is that individuals should be given credit for previous insurance when moving from one group plan to another.

Medicaid must send certificates of coverage to individuals upon request. The certificate must be sent to individuals who request one regardless of the status of the case (open or closed). We must also issue certificates automatically when an individual loses Medicaid coverage. The certificate will show time periods of Medicaid eligibility back to 7/1/96.

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14950** Guaranteed Eligibility {#sec-14000-14950 omnilex-key=us-de-regs-official--title-16--14000-14950}

All guaranteed eligibility will end effective 9/30/2002. Individuals who lose eligibility effective 4/30/2002 may receive up to five more months of guaranteed eligibility. Individuals who lose eligibility 5/31/2002 or after will not receive a period of guaranteed eligibility

14950.1 Coverage Under the DSHP Benefits Package

The service package and wrap around services are described in the General Policy Section of the Delaware Medical Assistance Program Provider Services Manual.

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14960** Cost Sharing {#sec-14000-14960 omnilex-key=us-de-regs-official--title-16--14000-14960}

Section 1902(a)(14) of the Social Security Act permits states to require certain recipients to share some of the costs of Medicaid by imposing upon them such payments as enrollment fees, premiums, deductibles, coinsurance, co-payments, or similar cost sharing charges.

14960.1 Co-Payment Requirement

Effective January 10, 2005, clients have a nominal co-payment for generic and brand name prescription drugs as well as over-the-counter drugs prescribed by a practitioner.

The co-payment is based upon the cost of the drug as follows:

Medicaid Payment for the Drug

Co-payment

$10.00 or less

$.50

$10.01 to $25.00

$1.00

$25.01 to $50.00

$2.00

$50.01 or more

$3.00

The co-payment is imposed for each drug that is prescribed and dispensed.

149601.1 Cumulative Maximum Monthly Co-payment

Effective July 1, 2005, there is a cumulative maximum monthly co-payment amount equal to $15.00 for each recipient. Any prescriptions dispensed after the cumulative maximum monthly co-payment amount is met are not subject to a co-payment.

14960.2 Exclusions from Co-payment Requirement

The following individuals and services are excluded from the co-payment requirement:

a. individuals under age 21

b. pregnant women, including the postpartum period

c. individuals eligible under the long term care nursing facility group or the acute care hospital group

d. emergency services

e. family planning services and supplies

f. hospice services

14960.3 Inability to Pay

The pharmacy provider may not refuse to dispense the prescription(s) subject to the co-payment requirement because of the individual's inability to pay the co-payment amount. When a recipient indicates that he or she is unable to meet the co-payment requirement, the pharmacy provider must dispense the prescription(s) as written. Medicaid reimbursement for the prescription(s) will be the Medicaid fee minus the applicable co-payment amount.

The recipient remains liable for the co-payment amount and is responsible for paying the pharmacy when financially able. The pharmacy provider is permitted to pursue reimbursement of the co-payment amount from the recipient.

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

##### **16 Del. Admin. Code § 14000-14970** Medicare Prescription Drug Program {#sec-14000-14970 omnilex-key=us-de-regs-official--title-16--14000-14970}

The Medicare Prescription Drug, Improvement and Modernization Act of 2003 established the Medicare Prescription Drug Program, also known as Medicare Part D, making prescription drug coverage available to individuals who are entitled to receive Medicare benefits under Part A or Part B, beginning on January 1, 2006. Coverage for the prescription drug benefit will be provided through private prescription drug plans (PDPs), which will offer only prescription drug coverage, or through Medicare Advantage prescription drug plans (MA-PDs), which will offer prescription drug coverage that is integrated with the health care coverage they provide to Medicare beneficiaries under Part C of Medicare.

Effective January 1, 2006, Medicaid beneficiaries who are entitled to receive Medicare benefits under Part A or Part B will no longer receive their pharmacy benefits under the Medicaid Program, except for drugs that are excluded from Part D. Any prescribed drug covered by Medicaid remains subject to the Medicaid co-payment requirement.

**History**
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *22 DE Reg. 66 (07/01/18)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *9 DE Reg. 774 (11/01/05)*
- *17 DE Reg. 731 (01/01/14)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *23 DE Reg. 303 (10/01/19)*
- *15 DE Reg. 362 (09/01/11)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *17 DE Reg. 503 (11/01/13)*
- *23 DE Reg. 303 (10/01/19)*
- *26 DE Reg. 212 (09/01/22)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *23 DE Reg. 303 (10/01/19)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 654 (01/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *14 DE Reg. 1361 (06/01/11)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 1023 (01/01/12)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *13 DE Reg. 1540 (06/01/10)*
- *15 DE Reg. 202 (08/01/11)*
- *15 DE Reg. 84 (07/01/11)*
- *12 DE Reg. 1416 (05/01/09)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*
- *26 DE Reg. 590 (01/01/23)*
- *27 DE Reg. 680 (03/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *17 DE Reg. 503 (11/01/13)*
- *27 DE Reg. 680 (03/01/24)*
- *27 DE Reg. 680 (03/01/24)*
- *12 DE Reg. 446 (10/01/08)*
- *15 DE Reg. 1717 (06/01/12)*
- *15 DE Reg. 1717 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *15 DE Reg. 1716 (06/01/12)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *26 DE Reg. 952 (05/01/23)*
- *26 DE Reg. 952 (05/01/23)*
- *15 DE Reg. 202 (08/01/11)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *13 DE Reg. 1540 (06/01/10)*
- *26 DE Reg. 952 (05/01/23)*
- *9 DE Reg. 569 (10/01/05)*
- *9 DE Reg. 569 (10/01/05)*
- *8 DE Reg. 1017 (01/01/05)*
- *9 DE Reg. 774 (11/01/05)*

#### **15000** Family and Community Medicaid Eligibility Groups

##### **16 Del. Admin. Code § 15000-15100** Parent/Caretaker Relative Group {#sec-15000-15100 omnilex-key=us-de-regs-official--title-16--15000-15100}

This section describes the eligibility requirements for the Parent/Caretaker Relative Group in accordance with Section 1931 of the Social Security Act.

15100.1 Definitions

The following words and terms, when used in the context of these policies, will have the following meaning unless the context clearly indicates otherwise:

“Caretaker relative” means a relative of a dependent child by blood, adoption, or marriage with whom the child is living, who assumes primary responsibility for the child’s care, and who is one of the following:

(1) The child’s father, mother, grandfather, grandmother, brother, sister, stepfather, stepmother, stepbrother, stepsister, uncle, aunt, first cousin, nephew, or niece.

(2) The spouse of such parent or relative, including same sex marriage or civil union, even after the marriage or civil union is terminated by death or divorce.

(3) Another relative of the child based on blood (including those of half-blood), adoption, or marriage; the domestic partner of the parent or caretaker relative; or an adult with whom the child is living and who assumes primary responsibility for the dependent child’s care.

“Dependent Child” means a child who is under age 18 or is age 18 and a full-time student in a secondary school (or equivalent vocational or technical training), and if before attaining age 19, the child may reasonably be expected to compete such school or training.

15100.2 Parent/Caretaker Relative General Eligibility Requirements

An individual must meet the general eligibility requirements described in Section 14000.

15100.3 Technical Eligibility

A parent or caretaker relative may be eligible under this group when the parent or caretaker relative assumes primary responsibility for the care and control of a dependent child living in their household even if the child or parent or caretaker relative is temporarily absent.

15100.4 Financial Eligibility

Financial eligibility is determined using the modified adjusted gross income (MAGI) methodologies described in Section 16000.

Household income must not exceed 87% of the Federal Poverty Level (FPL).

**History**
- *26 DE Reg. 323 (10/01/22)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 845 (02/01/14)*
- *26 DE Reg. 323 (10/01/22)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 845 (02/01/14)*
- *28 DE Reg. 45 (07/01/24)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *20 DE Reg. 908 (05/01/17)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*

##### **16 Del. Admin. Code § 15000-15110** Transitional Group {#sec-15000-15110 omnilex-key=us-de-regs-official--title-16--15000-15110}

This section describes the eligibility requirements for the Transitional Group in accordance with Section 1925 of the Social Security Act. Transitional Group eligibility is an extended eligibility period of up to twelve months for a family who becomes ineligible due to an increase in earned income or hours of employment. Transitional Group eligibility is divided into two periods of six months each.

The twelve-month extension period shall be rescinded when federal authorization or the allocation of federal funding is discontinued and shall include an extension period of four consecutive months described in Section 15110.10.

15110.1 Transitional Group General Eligibility Requirements

An individual must meet the general eligibility requirements described in Section 14000.

15110.2 Three out of Six Months Requirement

An individual must have received Medicaid under Section 15100 Parent/Caretaker Relative Group in three of the six months immediately preceding the month of ineligibility under such section.

A parent or caretaker relative is considered to have received Medicaid in any month Medicaid was correctly provided. This does not include Medicaid provided:

Medicaid must have been received in Delaware for three out of the six months.

15110.3 Increase in Earned Income or Hours of Employment

The family must become ineligible for Medicaid because of an increase in earned income or hours of employment of the parent or caretaker relative.

This happens when:

The increase in earned income or hours of employment must have a causative effect on the loss of eligibility. The following steps are used to determine if an increase in earned income (or other factor) had a causative effect.

1. Determine if the increase in earned income or hours of employment would have resulted in the loss of eligibility if all other factors in the case remained the same (there was no other change in income, no change in family composition, etc.).

If yes, the family is eligible for the Transitional Group.

If no, go to step 2.

2. Determine if events other than the increase in earned income or hours of employment would have resulted in the loss of eligibility if the earned income or hours of employment had stayed the same.

If yes, the family is not eligible for the Transitional Group.

If no, go to step 3.

3. Determine if the family is ineligible when all changes are considered.

If yes, the family is eligible for the Transitional Group. The increase in earned income or hours of employment was essential to the loss of eligibility. Without that increase, the family would not have lost eligibility.

If no, eligibility continues under the Parent/Caretaker Relative Group.

15110.4 Child Living in the Home

The parent or caretaker relative must continue to have a dependent child, as defined in Section 15100.1 living in the home.

When the only child no longer meets the age requirement, the parent or caretaker relative is no longer eligible for the Transitional Group. When one child turns age 18 or 19, but there is another child in the family, the child who turns age 18 or 19 is no longer considered a member of the Transitional Group family unit. The rest of the family remains eligible for the Transitional Group.

15110.5 Composition of a Transitional Group Family Unit

Transitional Group coverage is provided to all individuals who were included in the family at the time the family became ineligible. This includes a dependent child under the Children Group described in Section 15300. A recipient of SSI is not included in the family unit. Family members who enter the household or family members who were absent but return may be found eligible. An individual who enters the family unit (including a child born to the family during the transitional period) may be eligible for Transitional Group coverage if that individual would have been included in the parent or caretaker relative’s family unit if the household were applying in the current month.

The earned income of an individual who has entered or returned to the family unit is included in the gross earnings test and that individual is counted when determining the family size. The earned income of a dependent child, regardless of student status, is not counted.

15110.6 First Month of Transitional Group Eligibility

Transitional Group eligibility begins with the month of ineligibility under the Parent/Caretaker Relative Group due to an increase in earned income or hours of employment. A family who is not timely in reporting the start of employment or an increase in earned income or hours of employment could have the extension period reduced. The family must be notified they are eligible for the Transitional Group and the reasons why coverage under the Transitional Group could be terminated.

**History**
- *26 DE Reg. 323 (10/01/22)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 845 (02/01/14)*
- *26 DE Reg. 323 (10/01/22)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 845 (02/01/14)*
- *28 DE Reg. 45 (07/01/24)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *20 DE Reg. 908 (05/01/17)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*

##### **16 Del. Admin. Code § 15000-15110.7** Transitional Group Eligibility during First Six-Month Period {#sec-15000-15110.7 omnilex-key=us-de-regs-official--title-16--15000-15110.7}

The family will receive Transitional Group coverage without any reapplication for the first six months. To continue to receive Transitional Group coverage throughout the first six-month period there must be a dependent child living in the home. Eligibility will be terminated if the family is found to have received Medicaid fraudulently in the preceding six months. A conviction for fraud must be made by a court of competent jurisdiction.

15110.8 Transitional Group Eligibility during Second Six-Month Period

To continue to receive Medicaid during the second six-month period, the following eligibility conditions described in Section 15110.8.1, Section 15110.8.2, and Section 15110.8.3 must be met.

15110.8.1 Child Living in the Home

There must be a dependent child living in the home.

15110.8.2 Employment of Caretaker Relative

The parent or caretaker relative must be employed during each month unless good cause exists.

Good cause includes the following:

a. Circumstances beyond the individual's control such as but not limited to illness, illness of another family member requiring the wage earner’s presence, a household emergency, the unavailability of transportation, and the lack of adequate dependent care.

b. Circumstances in which employment was unsuitable such as wages offered less than the Federal minimum wage; employment on a piece-rate basis and the average hourly yield the employee receives is less than the Federal minimum wage; unreasonable degree of risk to one's health and safety; the individual is physically or mentally unfit to perform the employment as documented by medical evidence or reliable information from other sources; the distance from the individual's house to place of employment is unreasonable considering the expected wage and the time and cost of commuting; or the working hours or nature of employment interferes with the members religious observance, convictions or beliefs.

c. Discrimination by an employer based on age, race, sexual orientation or gender identity, disability, religious belief, national origin, or political belief.

d. Work demands or conditions that are unreasonable such as working without being paid on schedule.

e. Acceptance of other employment or enrollment at least half-time in a school, training program, or college.

f. Resignations by persons under the age of 60 that are recognized by the employer as retirement.

g. Leaving a job in connection with patterns of employment in which workers move from one employer to another as in migrant farm labor or in construction work.

15110.8.3 Limit on Gross Monthly Earned Income

The family's gross monthly earned income minus the monthly costs of necessary dependent care must not exceed 185% of the federal poverty level (FPL). The FPL is effective each July for the Transitional Group. There are no limits on necessary dependent care costs. All unearned income and the earned income of a dependent child is excluded.

15110.9 Twelve-Month Period of Transitional Group Eligibility

A family may receive twelve months of Transitional Group coverage even if eligibility is re-established under the Parent/Caretaker Relative Group. The clock on the twelve-month period does not stop running when eligibility for Medicaid under this group is re-established. The twelve months of Transitional Group eligibility run concurrently with months of eligibility under the Parent/Caretaker Relative Group.

If eligibility is lost under the Parent/Caretaker Relative Group for non-work reasons, the Transitional Group extension period is unaffected. If eligibility is lost again under the Parent/Caretaker Group for earned income, a new Transitional Group period may begin.

15110.10 Four-Month Period of Transitional Group Eligibility

This section applies if the twelve-month extension period described above is not re-authorized. A family may receive up to four months of Transitional Group coverage provided the requirements described in Section 15110.2, Section 15110.3, and Section 15110.4 are met. There is no income test throughout the four-month period.

**History**
- *26 DE Reg. 323 (10/01/22)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 845 (02/01/14)*
- *26 DE Reg. 323 (10/01/22)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 845 (02/01/14)*
- *28 DE Reg. 45 (07/01/24)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *20 DE Reg. 908 (05/01/17)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*

##### **16 Del. Admin. Code § 15000-15120** Prospective Group {#sec-15000-15120 omnilex-key=us-de-regs-official--title-16--15000-15120}

This section describes the eligibility requirements under the Prospective Group. Prospective Group is an extended eligibility period of up to four consecutive calendar months for a family who becomes ineligible due to an increased collection of spousal support.

15120.1 Prospective Group General Eligibility Requirements

An individual must meet the general eligibility requirements described in Section 14000.

15120.2 Three out of Six Months Requirement

An individual must have received Delaware Medicaid under the Parent/Caretaker Relative group in three of the six month immediately preceding the month of ineligibility under that section.

A parent or caretaker relative is considered to have received Medicaid in any month Medicaid was correctly provided. This does not include Medicaid provided:

15120.3 Collection of Spousal Support

The parent or caretaker relative must have lost eligibility wholly or partly as a result of new or increased spousal support collections. The collection of spousal support must cause or actively contribute to ineligibility. Regulations require that the collection of spousal support be paid directly to the IV-D agency – the Delaware Division of Child Support Enforcement.

15120.4 Child Living in the Home

The parent or caretaker relative must continue to have a dependent child as defined in Section 15100.1 living in the home.

When the only child no longer meets the age requirement, the parent or caretaker relative is no longer eligible for Prospective Group coverage. When one child turns age 18 or 19, but there is another child in the family, the child who turns age 18 or 19 is no longer considered a member of the Prospective Group family unit. The rest of the family remains eligible for Prospective Group coverage.

15120.5 First Month of Prospective Group Eligibility

Prospective Group eligibility begins with the month of ineligibility under the Parent/Caretaker Relative Group due to new or increased spousal support collections. A family who is not timely in reporting the start of new or increased spousal support collections could have the extension period reduced. The family must be notified they are eligible for the Prospective Group and the reasons why Prospective Group coverage could be terminated.

15120.6 Composition of Prospective Group Family Unit

Prospective is provided to all individuals who were included in the family at the time the family became ineligible. This includes a dependent child in the Children Group defined in Section 15300. In addition, family members who enter the household or family members who were absent but return may be found eligible. An individual who enters the family unit (including a child born to the family during the extended period) may be eligible for Prospective Group coverage if that individual would have been included in the parent or caretaker relative’s family unit if the household were applying in the current month.

**History**
- *26 DE Reg. 323 (10/01/22)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 845 (02/01/14)*
- *26 DE Reg. 323 (10/01/22)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 845 (02/01/14)*
- *28 DE Reg. 45 (07/01/24)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *20 DE Reg. 908 (05/01/17)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*

##### **16 Del. Admin. Code § 15000-15200** Pregnant Woman Group {#sec-15000-15200 omnilex-key=us-de-regs-official--title-16--15000-15200}

The section describes the eligibility requirements for the Pregnant Woman Group.

15200.1 Definitions

Statutory Authority

42 CFR 435.116

42 CFR 435.170

The following words and terms, when used in the context of these policies, will have the following meaning unless the context clearly indicates otherwise:

“Pregnant Woman” means a woman during pregnancy and the post partum period, which begins on the date the pregnancy ends, extends 12 months, and then ends on the last day of the month in which the 12 month period ends.

See 15200.1 Definitions - History

15200.2 Pregnant Woman Group General Eligibility Requirements

A pregnant woman must meet the general eligibility requirements described in Section 14000. Exception: A pregnant woman is not required to cooperate in establishing paternity and obtaining medical support.

15200.3 Technical Eligibility

A woman may apply for Medicaid and be found eligible under the Pregnant Woman Group in the month the pregnancy

ends or in a month prior to the month the pregnancy ends (while still pregnant), including during a period of retroactive eligibility.

Self-attestation of pregnancy and the unborn fetus count is accepted unless the information provided is not reasonably compatible with other available information. Other available information may include medical claims that are not reasonably compatible with such attestation.

15200.4 Financial Eligibility

Financial eligibility is determined using the modified adjusted gross income (MAGI) methodologies described in Section 16000. The pregnant woman counts as at least two family members for the financial eligibility determination. If a pregnant woman is diagnosed with a multiple pregnancy, the unborn fetus count is increased accordingly.

Household income must not exceed 212% of the Federal Poverty Level (FPL).

15200.5 Continuous Eligibility

Once a pregnant woman is determined eligible, she remains eligible throughout the pregnancy and the postpartum period regardless of changes in household income.

15200.6 Postpartum Period

Statutory Authority

42 CFR 435.116

42 CFR 435.170

The 12-month postpartum period is a mandatory extension of coverage for women who were determined eligible in the month the pregnancy ends, in a month prior to the month the pregnancy ends (while still pregnant), or who received services while pregnant during a period of retroactive eligibility. A woman cannot apply and be found eligible for the postpartum period alone. Coverage begins on the day the pregnancy ends and continues through the last day of the month in which the 12 months ends.

Undocumented aliens are not eligible for the postpartum period.

**History**
- *26 DE Reg. 323 (10/01/22)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 845 (02/01/14)*
- *26 DE Reg. 323 (10/01/22)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 845 (02/01/14)*
- *28 DE Reg. 45 (07/01/24)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *20 DE Reg. 908 (05/01/17)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*

##### **16 Del. Admin. Code § 15000-15210** Deemed Newborn Group {#sec-15000-15210 omnilex-key=us-de-regs-official--title-16--15000-15210}

The section describes the eligibility requirements for the Deemed Newborn Group.

An infant born to a woman eligible for and receiving Delaware Medicaid (including emergency services and labor and delivery only coverage) on the date of the infant’s birth is deemed eligible at birth.

**History**
- *26 DE Reg. 323 (10/01/22)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 845 (02/01/14)*
- *26 DE Reg. 323 (10/01/22)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 845 (02/01/14)*
- *28 DE Reg. 45 (07/01/24)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *20 DE Reg. 908 (05/01/17)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*

##### **16 Del. Admin. Code § 15000-15210.1** Deemed Newborn Group General Eligibility Requirements {#sec-15000-15210.1 omnilex-key=us-de-regs-official--title-16--15000-15210.1}

An infant must meet the general eligibility requirements described in Section 14000.

Exceptions: An application for the newborn is not required. A newborn deemed eligible does not have to provide or apply for a Social Security number until age one.

15210.2 Financial Eligibility

There is no income test. Eligibility begins on the date of birth and continues until the end of the month in which the infant turns age one regardless of changes in income. The newborn’s eligibility is not dependent on the continuation of the mother’s eligibility for Medicaid.

**History**
- *26 DE Reg. 323 (10/01/22)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 845 (02/01/14)*
- *26 DE Reg. 323 (10/01/22)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 845 (02/01/14)*
- *28 DE Reg. 45 (07/01/24)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *20 DE Reg. 908 (05/01/17)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*

##### **16 Del. Admin. Code § 15000-15300** Children Group {#sec-15000-15300 omnilex-key=us-de-regs-official--title-16--15000-15300}

This section describes the eligibility requirements for the Children Group.

15300.1 Children Group General Eligibility Requirements

A child must meet the general eligibility requirements described in Section 14000.

15300.2 Technical Eligibility

A child must be under age 19.

15300.3 Financial Eligibility

Financial eligibility is determined using the modified adjusted gross income (MAGI) methodologies described in Section 16000.

Household income for children under age 1 must not exceed 212% of the Federal Poverty Level (FPL).

Household income for children age 1 through age 5 must not exceed 142% of the Federal Poverty Level (FPL).

Household income for children age 6 through age 18 must not exceed 133% of the Federal Poverty Level (FPL).

15300.4 Mandatory Continuation of Coverage for Children Receiving Inpatient Services

A child receiving inpatient services in a hospital or long-term care facility at the end of the month in which the child turns age 19 remains eligible until the end of the inpatient stay. The child must continue to meet the general and financial eligibility requirements described in Section 15300.1 and Section 15300.3.

**History**
- *26 DE Reg. 323 (10/01/22)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 845 (02/01/14)*
- *26 DE Reg. 323 (10/01/22)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 845 (02/01/14)*
- *28 DE Reg. 45 (07/01/24)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *20 DE Reg. 908 (05/01/17)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*

##### **16 Del. Admin. Code § 15000-15400** Adult Group {#sec-15000-15400 omnilex-key=us-de-regs-official--title-16--15000-15400}

This section describes the eligibility requirements for the Adult Group.

15400.1 Definitions

The following words and terms, when used in the context of these policies, will have the following meaning unless the context clearly indicates otherwise:

“Minimum essential coverage” means coverage defined in section 5000A(f) of subtitle D of the Internal Revenue Code, as added by section 1401 of the Affordable Care Act, and implementing regulations of such section issued by the Secretary of the Treasury. Minimum essential coverage includes any of the following:

15400.2 Adult Group General Eligibility Requirements

An adult must meet the general eligibility requirements described in Section 14000.

15400.3 Technical Eligibility

An adult must:

a) be age 19 or older and under age 65;

b) not be pregnant;

c) not be entitled to or enrolled in Medicare Part A or B;

d) not be eligible under the following mandatory groups – Supplement Security Income (SSI) and related groups, Parent/Caretaker Relative, Transitional, Prospective, Pregnant Woman, Deemed Newborn, Children, Former Foster Child, or Title IV-E Foster Children.

A parent or caretaker relative living with a dependent child as defined in Section 15100.1 shall not be eligible in the Adult Group unless the child is enrolled in minimum essential coverage.

15400.4 Financial Eligibility

Financial eligibility is determined using the modified adjusted gross income (MAGI) methodologies in Section 16000.

Household income must not exceed 133% of the Federal Poverty Level (FPL).

**History**
- *26 DE Reg. 323 (10/01/22)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 845 (02/01/14)*
- *26 DE Reg. 323 (10/01/22)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 845 (02/01/14)*
- *28 DE Reg. 45 (07/01/24)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *20 DE Reg. 908 (05/01/17)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*

##### **16 Del. Admin. Code § 15000-15500** Title IV-E Foster Children Group {#sec-15000-15500 omnilex-key=us-de-regs-official--title-16--15000-15500}

This section describes the eligibility requirements for Title IV-E Foster Children Group.

15500.1 Title IV-E Foster Children Group General Eligibility Requirements

The child must meet the general eligibility requirements in Section 14000. Exception: The state of residence is the state where the child lives even if the foster care payment originates from another state.

15500.2 Technical Eligibility

Age: The child must be under age 21.

Payment by a Public Agency: The child must receive foster care maintenance payments under Title IV-E of the Social Security Act.

15500.3 Eligibility Determination

The Delaware Department of Services for Children, Youth, and their Families (DSCYF) is responsible for the eligibility determination.

**History**
- *26 DE Reg. 323 (10/01/22)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 845 (02/01/14)*
- *26 DE Reg. 323 (10/01/22)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 845 (02/01/14)*
- *28 DE Reg. 45 (07/01/24)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *20 DE Reg. 908 (05/01/17)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*

##### **16 Del. Admin. Code § 15000-15510** Foster Children Group {#sec-15000-15510 omnilex-key=us-de-regs-official--title-16--15000-15510}

(Repealed)

15510.1 Foster Children Group General Eligibility Requirements

(Repealed)

15510.2 Technical Eligibility

(Repealed)

15510.3 Financial Eligibility

(Repealed)

15510.4 Effective Date of Coverage

(Repealed)

15520 Adoption Assistance Group

This section describes the eligibility requirements for the Adoption Assistance Group.

15520.1 Adoption Assistance Group General Eligibility Requirements

The child must meet the general eligibility requirements described in Section 14000. The state of residence is the state where the child lives even if the adoption agreement originates from another state.

15520.2 Technical Eligibility Requirements

Age: The child must be under age 21.

Adoption Assistance: There must be an adoption assistance agreement in effect under Title IV-E of the Social Security Act, whether or not an adoption assistance payment is being made or an interlocutory (the final order of adoption) or other judicial decree of adoption has been issued.

15520.3 Eligibility Determination

Delaware Department of Services for Children, Youth, and Their Families (DSCYF) is responsible for the eligibility determination.

15530 Adoption Subsidy Group

This section describes the eligibility requirements for the Adoption Subsidy Group.

15530.1 Adoption Subsidy Group General Eligibility Requirements

The child must meet the general eligibility requirements described in Section 14000.

15530.2 Technical Eligibility

Age: The child must be under age 21.

Adoption Agreement: There must be an adoption assistance agreement (other than an agreement under Title IV-E of the Social Security Act) in effect for a child with special needs for medical or rehabilitative care. Children moving into Delaware from another state must have a signed adoption assistance agreement with the former state. The child must have been Medicaid eligible prior to the adoption assistance agreement.

Subsidy: The child must receive a medical/psychological subsidy from Delaware Department of Services for Children, Youth, and Their Families (DSCYF).

15530.3 Financial Eligibility

There is no income or resource test.

**History**
- *26 DE Reg. 323 (10/01/22)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 845 (02/01/14)*
- *26 DE Reg. 323 (10/01/22)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 845 (02/01/14)*
- *28 DE Reg. 45 (07/01/24)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *20 DE Reg. 908 (05/01/17)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*

##### **16 Del. Admin. Code § 15000-15540** Infants Awaiting Adoption Group {#sec-15000-15540 omnilex-key=us-de-regs-official--title-16--15000-15540}

(Repealed)

15540.1 Infants Awaiting Adoption Group General Eligibility Requirements

(Repealed)

15540.2 Technical Eligibility

(Repealed)

15540.3 Financial Eligibility

(Repealed)

15540.4 Effective Date of Coverage

(Repealed)

15540.5 Termination of Eligibility

(Repealed)

**History**
- *26 DE Reg. 323 (10/01/22)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 845 (02/01/14)*
- *26 DE Reg. 323 (10/01/22)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 845 (02/01/14)*
- *28 DE Reg. 45 (07/01/24)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *20 DE Reg. 908 (05/01/17)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*

##### **16 Del. Admin. Code § 15000-15550** Former Foster Children Group {#sec-15000-15550 omnilex-key=us-de-regs-official--title-16--15000-15550}

This section describes the eligibility requirements for the Former Foster Children Group. This group is established through the enactment of the Affordable Care Act of 2010. Coverage under this group is effective January 1, 2014.

15550.1 Former Foster Children Group General Eligibility Requirements

An individual must meet the general eligibility requirements in Section 14000.

15550.2 Technical Eligibility

An individual must:

15550.2.1 be age 18 or older and under age 26; and

15550.2.2 have been in foster care under the responsibility of the Delaware Department of Services for Children, Youth, and Their Families (DSCYF) and enrolled in Delaware Medicaid upon attaining age 18 or older (up to age 21); or

15550.2.3 Have been in foster care and on Medicaid in any state at the time they turned 18 or aged out of the foster care system; and

15550.2.4 not be eligible under the following mandatory groups – Parent/Caretaker Relative, Transitional, Prospective, Pregnant Women, Children, and Supplemental Security Income (SSI).

15550.3 Financial Eligibility

There is no income or resource test for this group.

**History**
- *26 DE Reg. 323 (10/01/22)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 845 (02/01/14)*
- *26 DE Reg. 323 (10/01/22)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 845 (02/01/14)*
- *28 DE Reg. 45 (07/01/24)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *20 DE Reg. 908 (05/01/17)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*

##### **16 Del. Admin. Code § 15000-15600** Breast and Cervical Cancer Group {#sec-15000-15600 omnilex-key=us-de-regs-official--title-16--15000-15600}

This section describes the eligibility requirements for the Breast and Cervical Cancer Group. This group includes uninsured women who are identified through the Centers for Disease Control (CDC) National Breast and Cervical Cancer Early Detection Program (NBCCEDP) and are in need for treatment for breast or cervical cancer, including pre-cancerous conditions and early stage cancer.

15600.1 Definitions

The following words and terms, when used in the context of these policies, will have the following meaning unless the context clearly indicates otherwise:

“Comprehensive health insurance” means a benefit package comparable in scope to the "basic" benefit package required by the State of Delaware's Small Employer Health Insurance Act at Title 18, Chapter 72 of the Delaware Code. To be considered comprehensive health insurance, the benefits package must cover hospital and physician services, laboratory and radiology, and must include coverage for the treatment of breast and cervical cancer.

Comprehensive health insurance does not include time periods when there is no coverage for the treatment of breast or cervical cancer. Examples include when coverage is effective only after a waiting period of uninsurance or after the lifetime limits are exhausted.

Comprehensive health insurance does include insurance that has limits on benefits (such as limits on the number of outpatient visits per year) or high deductibles.

15600.2 Breast and Cervical Cancer Group General Eligibility Requirements

A woman must meet the general eligibility requirements described in Section 14000.

15600.3 Technical Eligibility

Age: The woman must be under age 65. If a woman turns age 65 during her period of coverage, her eligibility terminates. Exception: If the woman is an inpatient in a hospital when she turns 65, eligibility continues until discharge.

Uninsured:

The woman must be uninsured. The woman is not eligible if she has:

a) Medicaid or may be found eligible under any of the following Medicaid mandatory groups - Parent/Caretaker Relative, Transitional, Prospective, Pregnant Woman, Children, Title IV-E Foster Care, Title IV-E Adoption Assistance, or Supplemental Security Income (SSI);

b) Medicare;

c) Comprehensive health insurance;

d) Military Health Insurance for Active Duty, Retired Military, and their dependents.

Screening:

The woman must have been screened for breast or cervical cancer under the CDC Breast and Cervical Cancer Early Detection Program established under Title XV of the Public Health Service Act and found to need treatment for either breast or cervical cancer (including a pre-cancerous condition).

A woman is considered to have met the screening requirement if she comes under any of the following categories:

1. CDC Title XV funds paid for all or part of the costs of her screening services.

2. The woman is screened under a state Breast and Cervical Cancer Early Detection Program which her particular clinical service has not be paid for by CDC Title XV funds, but the service was rendered by a provider and/or an entity funded at least in part by CDC Title XV funds; the service was within the scope of the grant, sub-grant or contract under that State program; and the State CDC Title XV grantee has elected to include such screening activities by that provider as screening activities pursuant to CDC Title XV.

Treatment:

The woman must need treatment for breast or cervical cancer. The woman meets this requirement when it is the opinion of the woman's treating health professional that the diagnostic test following a breast or cervical cancer screen indicates that the woman is in need of cancer treatment services. These services included diagnostic services that may be necessary to determine the extent and proper course of treatment, as well as treatment itself.

Based on the physician's plan-of-care, a woman who is determined to require only routine monitoring services for a pre-cancerous breast or cervical condition (such as breast examination and mammograms), is not considered to need treatment.

15600.4 Financial Eligibility

There is no income or resource test.

15600.5 Presumptive Eligibility

Presumptive eligibility is a temporary eligibility determination that will provide expedited Medicaid coverage to women in this group during the application processing period. This special application processing procedure will facilitate the prompt enrollment and immediate access to services for women who are in need of treatment for breast or cervical cancer. An applicant can be determined presumptively eligible when the agency receives verification that she has been screened for breast or cervical cancer under CDC and needs treatment.

If the information on the application indicates that she may be eligible under one of the mandatory eligibility groups, the agency will first make a determination of presumptive eligibility under this group. Verifications of factors of eligibility for the mandatory group are postponed. Postponed verifications must be provided within 30 days from the date of receipt of the application. The verifications that were postponed are required to determine final eligibility for Medicaid. Presumptive eligibility continues until a final eligibility determination is completed. If the required verifications are not provided, eligibility is terminated.

If the information on the application indicates that the woman is not eligible under one of the mandatory groups, the agency will make a final determination of eligibility under this group provided all verification requirements are met.

15600.6 Eligibility Period

Eligibility may begin up to three months prior to the month of application provided the woman meets all eligibility requirements during those prior three months including having been screened and found to need treatment for breast or cervical cancer.

A woman is not limited to one period of eligibility. A new period of eligibility and coverage can begin each time a woman is screened under the CDC program, has been found to need treatment for breast or cervical cancer, and meets the other eligibility requirements.

15600.7 Benefits

A woman eligible under this group is entitled to full Medicaid coverage. Coverage is not limited to the treatment of breast and cervical cancer.

15600.8 Termination of Eligibility

Eligibility under this group terminates when the woman:

a) attains age 65;

b) acquires comprehensive health insurance;

c) is no longer receiving treatment for breast or cervical cancer

d) no longer meets the general eligibility requirements in Section 14000.

**History**
- *26 DE Reg. 323 (10/01/22)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 845 (02/01/14)*
- *26 DE Reg. 323 (10/01/22)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 845 (02/01/14)*
- *28 DE Reg. 45 (07/01/24)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *20 DE Reg. 908 (05/01/17)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*

##### **16 Del. Admin. Code § 15000-15700** Family Planning Group {#sec-15000-15700 omnilex-key=us-de-regs-official--title-16--15000-15700}

(Repealed)

15700.1 Family Planning Group General Eligibility Requirements

(Repealed)

15700.2 Technical Eligibility

(Repealed)

15700.3 Financial Eligibility

(Repealed)

15700.4 Benefits

(Repealed)

15700.5 Termination of Eligibility

(Repealed)

**History**
- *26 DE Reg. 323 (10/01/22)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 845 (02/01/14)*
- *26 DE Reg. 323 (10/01/22)*
- *26 DE Reg. 952 (05/01/23)*
- *28 DE Reg. 387 (11/01/24)*
- *17 DE Reg. 845 (02/01/14)*
- *28 DE Reg. 45 (07/01/24)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *20 DE Reg. 908 (05/01/17)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 731 (01/01/14)*
- *17 DE Reg. 503 (11/01/13)*
- *17 DE Reg. 731 (01/01/14)*

#### **30000** Delaware Prescription Assistance Program

##### **16 Del. Admin. Code § 30000** Delaware Prescription Assistance Program {#sec-30000 omnilex-key=us-de-regs-official--title-16--30000}

Revised July 2018

The 149th General Assembly amended Title 16, Delaware Code, by reinstating Chapter 30B to restore the Delaware Prescription Drug Payment Assistance Program. The purpose of this act is to provide payment assistance for prescription drugs and certain Medicare Part D costs to low-income seniors and individuals with disabilities who are ineligible for, or do not have, prescription drug benefits or coverage through federal, (excluding Medicare Part D coverage, state, or private sources.

The program is administered by the Fiscal Agent under contract with the Delaware Department of Health and Social Services.

The rules in this section set forth the eligibility requirements for coverage under the Delaware Prescription Assistance Program (DPAP). The DPAP is reinstated as of January 1, 2019, with benefits beginning January 14, 2019.

30100 Definitions

Revised July 2018

Contractor: The agent who is under contract with the State to administer the DPAP.

Department: The Department of Health and Social Services or DHSS

Division: The Division of Medicaid & Medical Assistance or DMMA

Low Income Subsidy (LIS): Assistance provided by the Centers for Medicare and Medicaid Services to pay Medicare Part D costs for individuals with limited income and resources. The LIS will provide payment assistance with the monthly premium, the yearly deductible, and the coverage gap. The LIS will also provide payment assistance for co-payments after an individual with income below 135% of the Federal Poverty Level reaches a total of $5100 in drug expenses.

Medicare Part D: The Medicare Prescription Drug Program established by the Medicare Prescription Drug, Improvement and Modernization Act of 2003.

Medicare Part D costs: Monthly premiums, yearly deductible, and drug costs that fall into the Part D coverage gap.

Prescription drugs: Drugs that are self-administered or administered by a lay person that have been approved as safe and effective by the Federal Food and Drug Administration or are otherwise legally marketed in the United States. Mediations administered only by a clinically trained person are not covered under this program.

30200 General Application Information

Revised July 2018

The application for DPAP must be made in writing on the prescribed form. This request for assistance can be made by the applicant, guardian, or other individual acting for the applicant with the applicant's knowledge and consent. The application filing date is the date the application is received in either the Contractor's office or a DHSS office.

DPAP will consider an application without regard to race, color, age, sex, sexual orientation, gender identity, disability, religion, national origin, limited English proficiency (LEP) or political belief as per Title VI of the Civil Rights Act of 1964.

Filing an application gives the applicant the right to receive a written determination of eligibility and the right to appeal the written determination.

30201 Disposition of Applications

Revised July 2018

The Contractor must include in each applicant's case record facts to support the Contractor's decision on his application. The Contractor must dispose of each application by a finding of eligibility or ineligibility, unless:

a. There is an entry in the case record that the applicant voluntarily withdrew the application, and that the Contractor sent a notice confirming the applicant's decision; or

b. There is a supporting entry in the case record that the applicant has died; or

c. There is a supporting entry in the case record that the applicant cannot be located; or

d. All verification requested is not received by the due date given to the applicant. If all verification requested is not received by the due date, an eligibility determination cannot be made. This will result in denial of the application. Verification that is received and/or provided may reveal a new eligibility issue not previously realized that requires additional verification. If the additional verification requested is not received by the due date given, this will result in denial of the application.

All applicants will receive a notice of acceptance or denial.

30202 Timely Determination of Eligibility

Revised July 2018

A time standard of 45 days will apply. This standard equals the period from the application filing date to the date that the notice of decision is mailed. The standard must be met except in unusual circumstances, such as:

30203 Reporting Changes in Circumstances

Revised July 2018

At time of application and redetermination, each individual must be informed that he is responsible for notifying the Contractor of all changes in the applicant's circumstances, which could potentially affect the applicant's eligibility for DPAP.

30300 Technical Eligibility

Revised July 2018

The following requirements are factors of eligibility specific to DPAP.

30301 Citizenship and Alienage

Revised July 2018

The individual must be a U.S. citizen or a lawfully admitted alien.

30302 State Residency

Revised July 2018

The individual must be living in the State of Delaware.

30303 Social Security Number

Revised July 2018

Each individual applying for DPAP must furnish his or her Social Security number.

30304 Aged or Disabled Requirement

Revised July 2018

The individual must meet one of the following requirements:

a. Be age 65 or over; or

b. Be an individual between the ages of 19 and 64 who is receiving disability benefits under Title II of the Social Security Act. An individual is considered to meet the "receiving disability benefits" requirement if the individual is a former recipient of either Social Security Disability Insurance benefits or Supplemental Security Income benefits and was required by the Social Security Administration to accept Social Security Survivors benefits.

30305 Requirement to Enroll in Medicare Part D

Revised July 2018

An individual who is entitled to receive Medicare benefits under Part A or Part B must enroll in Part D in order to be eligible for DPAP. The individual must provide proof of Medicare Part D enrollment.

30306 Requirement to Apply for Low Income Subsidy (LIS)

Revised July 2018

An individual must apply for the LIS if potentially eligible. The individual must provide a copy of the LIS denial or approval notice.

30307 No Other Prescription Drug Coverage

Revised July 2018

The individual must not have or must be ineligible for, prescription drug benefits or coverage through federal (excluding Medicare Part D coverage), state, or private sources regardless of any annual limitations to the benefits.

The individual must not have or must be ineligible for:

a. Medicaid prescription benefits; and/or

b. Prescription drug benefits through a third party payer.

30307.1 Exceptions to No Other Prescription Drug Coverage

Revised July 2018

Individuals who are eligible for the following drug benefits will not be excluded from eligibility for DPAP:

a. Individuals covered under a specific disease state insurance program, for example a policy that pays only for cancer drugs

b. Individuals who are members of a discount drug program in which the policy does not actually pay for the drugs, for example American Association of Retired Persons (AARP)

c. Individuals eligible for drug coverage through the Division of Vocational Rehabilitation

d. Individuals eligible for drug coverage through the Division of Substance Abuse and Mental Health; and

e. Individuals covered under Medicare Part D.

30308 Inmate of a Public Institution

Revised July 2018

An individual who is an inmate of a public institution is not eligible for DPAP.

An individual is an inmate when serving time for a criminal offense or confined involuntarily in State or Federal prisons, jail, detention facilities, or other penal facilities. An individual awaiting trial in a detention center is considered an inmate of a public institution.

30400 Financial Eligibility

Revised July 2018

Income is any type of money payment that is of gain or benefit to an individual. Income is either counted or excluded for the eligibility determination.

30401 Countable Income

Revised July 2018

Countable income includes but is not limited to:

1. Social Security benefits - as paid after deduction for Medicare premium;

2. Pension - as paid;

3. Veterans Administration Pension - as paid;

4. U.S. Railroad Retirement Benefits - as paid;

5. Wages - net amount after deductions for taxes and FICA;

6. Senior Community Service Employment - net amount after deductions for taxes and FICA;

7. Interest/Dividends - gross amount;

8. Capital Gains - gross amount from capital gains on stocks, mutual funds, bonds;

9. Credit Life or Credit Disability Insurance Payments - as paid;

10. Alimony - as paid;

11. Rental Income from entire dwelling - gross rent paid minus standard deduction of 20% for expenses;

12. Roomer/Boarder Income - gross room/board paid minus standard deduction of 10% for expenses;

13. Self Employment - countable income as reported to Internal Revenue Service (IRS); and

14. Unemployment Compensation - as paid.

30402 Excluded Income

Revised July 2018

Excluded income includes but is not limited to:

1. Annuity payments;

2. Individual Retirement Account (IRA) distributions;

3. Payments from reverse mortgages;

4. Capital gains from the sale of principal place of residence;

5. Conversion or sale of a resource (i.e. cashing a certificate of deposit);

6. Income tax refunds;

7. Earned Income Tax Credit (EITC);

8. Vendor payments (bills paid directly to a third party on behalf of the individual);

9. Government rent/housing subsidy paid directly to individual (i.e. HUD utility allowance);

10. Loan payments received by individual;

11. Proceeds of a loan;

12. Foster care payments made on behalf of foster children living in the home;

13. Retired Senior Volunteer Program (RSVP);

14. Veterans Administration Aid and Attendance payments;

15. Victim Compensation payments;

16. German reparation payments;

17. Radiation Exposure Compensation Trust Fund payments;

18. Japanese-American, Japanese-Canadian, and Aleutian restitution payments; and/or

19. Payments from long term care insurance or for inpatient care paid directly to the individual.

30403 Eligibility Determination

Revised July 2018

To be eligible for DPAP:

a. The individual must have countable income that is less than 200% of the Federal Poverty Level (FPL); or

b. The individual has countable income that is equal to or greater than 200% of the FPL and the individual has prescription drug expenses that exceed 40% of the individual's countable income.

The Federal Poverty Level (FPL) is published annually. The income eligibility standard based on the FPL will be issued within 10 business days after the FPL is published. The revised income eligibility standard will be used to determine eligibility for the month following the month in which the standard is issued.

30404 Effective Date of Coverage

Revised July 2018

Coverage begins on the first day of the month following the month that eligibility is determined. There is no retroactive coverage. Eligible individuals will receive an identification card for DPAP.

30405 Annual Renewal of Eligibility

Revised July 2018

The eligibility of DPAP beneficiaries must be renewed once every twelve (12) months. The contractor will redetermine eligibility for DPAP without requiring information from the recipient. The Contractor will notify DPAP recipients of the following:

a. The eligibility determination; and

b. The recipient's responsibility to inform the Contractor of any changes in circumstances which could potentially affect the recipient's eligibility for DPAP.

DPAP coverage will be terminated when the Contractor or DSS DHSS is notified by the recipient that he or she no longer wants coverage.

30500 Benefits

Revised July 2018

Prescription drugs covered under DPAP are restricted to medically necessary products manufactured by pharmaceutical companies that agree to provide manufacturer rebates. Policy and guidelines will follow the existing Delaware Medical Assistance Program limitations. Services covered include generic and brand name prescription drugs that have been approved as safe and effective by the Federal Food and Drug Administration as well as cost effective over-the-counter drugs prescribed by a practitioner. Necessary diabetic supplies not covered by Medicare will also be covered. Medications that are covered by Medicare are not covered under DPAP.

30500.1 Benefits for Individuals with Medicare Part D Coverage

Revised July 2018

DPAP will provide payment assistance for Medicare Part D monthly premiums, yearly deductible, those drug costs that fall into the Part D coverage gap, and drugs that are excluded from Medicare Part D.

Medicare Part D coverage will be primary to payment assistance under DPAP.

30501 Limitations on Benefits

Revised July 2018

Payment assistance to each eligible individual shall not exceed $3,000.00 per benefit year. Individuals will receive a notice when 75% of the $3,000.00 cap has been expended.

30502 Co-payment Requirement

Revised July 2018

There is a co-payment of $5.00 or 25% of the cost of the prescription (whichever is greater) during the Part D deductible and coverage gap and for drugs that are excluded from Part D. DPAP will not provide payment assistance for Medicare Part D co-payments. When the individual receives a prescription drug that is covered under Medicare Part D, the individual is responsible for the Medicare Part D co-payment.

30600 Confidentiality

Revised July 2018

DPAP will provide safeguards that restrict the use or disclosure of information about applicants and recipients to purposes directly connected with the administration of the DPAP.

Purposes directly related to administration of the DPAP include establishing eligibility, providing services for recipients, determining the amount of medical assistance, and conducting or assisting an investigation, prosecution, or civil or criminal proceeding related to the administration of the program.

At a minimum, the types of information about applicants and recipients that must be safeguarded and not released without consent include:

1. Names and addresses;

2. Medical services provided;

3. Social and economic conditions or circumstances;

4. Contractor evaluation of personal information;

5. Medical data, including diagnosis and past history of disease or disability;

6. Information received for verifying income eligibility and amount of medical assistance payments; and

7. Information about third party liability.

30601 Release of Information to DPAP Providers

Revised July 2018

DPAP providers have a contractual obligation to safeguard information about recipients. Providers may have access to certain eligibility information if they can provide:

a. A DPAP identification number; or

b. Two of the following identifying factors: individual's full name, date of birth, Social Security number; AND the date of service.

Providers who supply the above identifying factors may be given the following information:

a. Correct spelling of the recipient's name;

b. DPAP number;

c. Date of birth;

d. An indication whether the individual is eligible for the date of service given or for a range of dates given. Providers may not be given all periods of eligibility.

30602 Release of Information to Others

Revised July 2018

At the time of application, individuals are informed that all eligibility information is confidential and disclosure without written permission of the individual is limited. DPAP has the authority to responsibly share information concerning applicants and recipients with:

a. DHSS employees;

b. Federal or federally assisted programs that provide assistance to individuals on the basis of need (SSI, HUD); and/or

c. Contracted service providers.

Information may also be released to comply with a subpoena or other valid court order.

DPAP must obtain specific written permission from the individual before releasing information to any other persons or sources.

30700 Fair Hearings

Revised July 2018

A fair hearing is an administrative hearing held in accordance with the principles of due process. An opportunity for a fair hearing will be provided, subject to the provisions in policy at DSSM 5000 - 5607.

**History**
- *22 DE Reg. 595 (01/01/19)*
- *22 DE Reg. 595 (01/01/19)*
- *22 DE Reg. 595 (01/01/19)*
- *22 DE Reg. 595 (01/01/19)*
- *22 DE Reg. 595 (01/01/19)*
- *22 DE Reg. 595 (01/01/19)*
- *22 DE Reg. 595 (01/01/19)*
- *22 DE Reg. 595 (01/01/19)*
- *22 DE Reg. 595 (01/01/19)*
- *22 DE Reg. 595 (01/01/19)*
- *22 DE Reg. 595 (01/01/19)*
- *22 DE Reg. 595 (01/01/19)*
- *22 DE Reg. 595 (01/01/19)*
- *22 DE Reg. 595 (01/01/19)*
- *22 DE Reg. 595 (01/01/19)*
- *22 DE Reg. 595 (01/01/19)*
- *22 DE Reg. 595 (01/01/19)*
- *22 DE Reg. 595 (01/01/19)*
- *22 DE Reg. 595 (01/01/19)*
- *22 DE Reg. 595 (01/01/19)*
- *22 DE Reg. 595 (01/01/19)*
- *22 DE Reg. 595 (01/01/19)*
- *22 DE Reg. 595 (01/01/19)*
- *22 DE Reg. 595 (01/01/19)*
- *22 DE Reg. 595 (01/01/19)*
- *22 DE Reg. 595 (01/01/19)*
- *22 DE Reg. 595 (01/01/19)*
- *22 DE Reg. 595 (01/01/19)*
- *9 DE Reg. 774 (11/01/05)*
- *10 DE Reg. 866 (11/01/06)*
- *21 DE Reg. 433 (11/01/17)*
- *22 DE Reg. 595 (01/01/19)*

#### **70000** Certification and Regulation of Medicaid Managed Care Organizations

##### **16 Del. Admin. Code § 70000-1** Authority and Purpose {#sec-70000-1 omnilex-key=us-de-regs-official--title-16--70000-1}

1.1 This regulation is promulgated pursuant to Section 7931(d) of Title 29, Delaware Code.

1.2 Pursuant to Section 1902(a)(4) of Title XIX of the Social Security Act (42 U.S.C. §1396a(4)) and 42 C.F.R. §438.1 et. seq., the states are authorized to administer Medicaid through Medicaid managed care organizations (each an “MMCO”).

1.3 Pursuant to 42 C.F.R. §438.116(a), an MMCO shall provide assurances satisfactory to the State showing that its provision against the risk of insolvency is adequate to ensure that its Medicaid enrollees will not be liable for its debts if the MMCO becomes insolvent.

1.4 Pursuant to 42 C.F.R. §438.116(b)(1), in order to make the required showing under Section 438.116(a), an MMCO must either meet state solvency requirements for a private health maintenance organization, or be licensed or certified by the State as a risk bearing entity.

1.5 Pursuant to 18 Del.C. §7931(c), the Division of Medicaid and Medical Assistance (“DMMA”), which is under the direction and control of the Secretary of the Department of Health and Social Services (“DHSS”), is responsible for the performance of all of the powers, duties, and functions specifically related to Medicaid, which includes certification of MMCOs.

1.6 The purpose of these regulations is to set forth standards for the certification of MMCOs as risk bearing entities.

**History**
- *21 DE Reg. 568 (01/01/18)*
- *21 DE Reg. 568 (01/01/18)*
- *21 DE Reg. 568 (01/01/18)*
- *18 DE Reg. 693 (03/01/15)*
- *21 DE Reg. 568 (01/01/18)*

##### **16 Del. Admin. Code § 70000-2** Formation and Existence {#sec-70000-2 omnilex-key=us-de-regs-official--title-16--70000-2}

2.1 Each MMCO seeking certification from DHSS shall demonstrate to the satisfaction of DHSS that:

2.1.1 The MMCO is duly formed and validly existing under the laws of the State of Delaware.

2.1.2 The MMCO has the necessary corporate or company power to enter into and perform its obligations under the State Medicaid Managed Care Contract (the “Contract”).

2.1.3 The MMCO has taken all necessary corporate or company action to authorize the execution, delivery and performance of the Contract.

2.1.4 The execution and delivery of the Contract will not, and the performance of the MMCO’s obligations under the Contract will not, result in a violation of any provision of the MMCO’s certificate of incorporation, bylaws or other governing instrument or document.

2.1.5 An opinion of Delaware counsel to the MMCO will be prima facie evidence that the criteria in this Section 2 are satisfied.

**History**
- *21 DE Reg. 568 (01/01/18)*
- *21 DE Reg. 568 (01/01/18)*
- *21 DE Reg. 568 (01/01/18)*
- *18 DE Reg. 693 (03/01/15)*
- *21 DE Reg. 568 (01/01/18)*

##### **16 Del. Admin. Code § 70000-3** Experience and Net Worth {#sec-70000-3 omnilex-key=us-de-regs-official--title-16--70000-3}

3.1 Either the MMCO, or a parent company or person affiliated with the MMCO, shall demonstrate, to the satisfaction of DHSS, the following:

3.1.1 Five years’ experience writing or administering health insurance benefits or administering health plans, or both.

3.1.2 Audited financial statements for the most recent calendar or fiscal year demonstrating, on a consolidated basis, generally accepted accounting principles and generally accepted auditing standards, net equity in excess of $10 million.

**History**
- *21 DE Reg. 568 (01/01/18)*
- *21 DE Reg. 568 (01/01/18)*
- *21 DE Reg. 568 (01/01/18)*
- *18 DE Reg. 693 (03/01/15)*
- *21 DE Reg. 568 (01/01/18)*

##### **16 Del. Admin. Code § 70000-4** Identification of Accountant, Auditor and Actuary {#sec-70000-4 omnilex-key=us-de-regs-official--title-16--70000-4}

4.1 Each MMCO seeking certification shall identify:

4.1.1 The person or persons responsible for preparing the MMCO’s financial statements in U.S. generally accepted accounting principles and generally accepted auditing standards format and for preparing any financial reporting required under the Contract. Such person shall have accounting or finance training and experience, and shall have experience in the preparation of financial statements for health plans.

4.1.2 The independent auditor that the MMCO proposes to engage for the purpose of auditing its financial books and records. Such independent auditor shall be a certified public accountant, or employ same, and shall be a member in good standing with the American Institute of Certified Public Accountants. The independent auditor shall have experience auditing health plans.

4.1.3 The actuary it proposes to use for the purpose of certifying loss reserves. Such actuary shall be a member of the American Academy of Actuaries in good standing and shall demonstrate experience in the setting and/or certification of loss reserves for health plans.

**History**
- *21 DE Reg. 568 (01/01/18)*
- *21 DE Reg. 568 (01/01/18)*
- *21 DE Reg. 568 (01/01/18)*
- *18 DE Reg. 693 (03/01/15)*
- *21 DE Reg. 568 (01/01/18)*

##### **16 Del. Admin. Code § 70000-5** Performance Bond {#sec-70000-5 omnilex-key=us-de-regs-official--title-16--70000-5}

5.1 Prior to certification, the MMCO shall obtain a performance bond from a surety licensed to write surety business in Delaware and rated A- (Excellent) or better by A.M. Best and Company. The performance bond shall be restricted to the Contract.

5.2 The performance bond shall identify the Delaware Department of Health and Social Services as obligee and shall be in the amount of the projected first month’s capitation payment under the Contract, as agreed to by the MMCO and DHSS.

5.3 The MMCO shall secure and maintain the performance bond in the amount of 100% of the first month of capitation payment for each of the first 12 months after the Start Date of Operations (as defined in the Contract).

5.4 If the performance bond falls below 90% of the first month’s capitation in any month, the MMCO has 30 calendar days to comply with the requirements of this Section and provide proof of the increased bond amount.

5.5 The terms of the performance bond shall be such as to allow for adjustment in the amount of the penal sum payable thereon in accordance with the performance bond requirements of the Contract.

**History**
- *21 DE Reg. 568 (01/01/18)*
- *21 DE Reg. 568 (01/01/18)*
- *21 DE Reg. 568 (01/01/18)*
- *18 DE Reg. 693 (03/01/15)*
- *21 DE Reg. 568 (01/01/18)*

##### **16 Del. Admin. Code § 70000-6** Initial Capitalization and Solvency {#sec-70000-6 omnilex-key=us-de-regs-official--title-16--70000-6}

6.1 Each MMCO seeking certification shall provide DHSS with a description of the MMCO’s capitalization and the manner in which it proposes to ensure solvency during the term of the Contract. This description may include one or a combination of some or all of the following:

6.1.1 A minimum level of paid-in capital and surplus as established by DHSS.

6.1.2 Reinsurance or insurance transactions.

6.1.3 Derivative instruments.

6.1.4 Guaranties from parent or affiliated entities.

6.1.5 Any other method determined by DHSS to provide adequate solvency safeguards.

6.2 Prior to certification, the MMCO shall provide DHSS with bank confirmations for all funds it identifies, or plans to identify, as assets on its financial statements.

6.3 Each MMCO seeking certification shall establish an investment policy for the investment of its assets. Such investment policy shall not deviate from the following:

6.3.1 Investments in any one entity shall not exceed 10% of the MMCOs’ assets unless:

6.3.1.1 Such investments are the voting stock or other interests in a subsidiary.

6.3.1.2 Such investments are general obligations of the United States or of a state.

6.3.1.3 Such investments are issued, assumed or guaranteed by an agency of the United States government, or in which the United States government is a participant.

6.3.2 Investments in medium or lower grade corporate obligations shall comply with the requirements of 18 Del.C. Ch. 13.

6.3.3 Investments in real estate mortgages and mortgage pools are permitted provided that such investments comply with the requirements of 18 Del.C. §1323.

6.3.4 Investments in the MMCO’s own capital stock or other equity interests are prohibited.

6.3.5 Notes or other evidence of indebtedness of any director, officer, employee or controlling shareholder of the MMCO are prohibited.

**History**
- *21 DE Reg. 568 (01/01/18)*
- *21 DE Reg. 568 (01/01/18)*
- *21 DE Reg. 568 (01/01/18)*
- *18 DE Reg. 693 (03/01/15)*
- *21 DE Reg. 568 (01/01/18)*

##### **16 Del. Admin. Code § 70000-7** Certification. {#sec-70000-7 omnilex-key=us-de-regs-official--title-16--70000-7}

7.1 If upon completion of its application, DHSS finds that the MMCO has met the requirements therefor under this regulation; DHSS shall issue to the MMCO a proper certificate confirming that the MMCO has been certified as a risk bearing entity for purposes of the Delaware Medicaid program. If DHSS finds that the MMCO has not met the requirements for certification under this regulation, DHSS shall issue an order refusing such certification.

7.2 DHSS’s certification of an MMCO as a risk bearing entity shall be limited to the MMCO’s business related to the Delaware Medicaid program and shall not authorize the MMCO to conduct business that would otherwise require licensure under Title 18 of the Delaware Code.

7.3 Although issued and delivered to the MMCO, the certificate issued pursuant to Section 7.1 of this regulation at all times shall be property of the State. Upon expiration, suspension or termination thereof, the MMCO shall promptly deliver the certificate to DHSS.

**History**
- *21 DE Reg. 568 (01/01/18)*
- *21 DE Reg. 568 (01/01/18)*
- *21 DE Reg. 568 (01/01/18)*
- *18 DE Reg. 693 (03/01/15)*
- *21 DE Reg. 568 (01/01/18)*

##### **16 Del. Admin. Code § 70000-8** Financial Stability {#sec-70000-8 omnilex-key=us-de-regs-official--title-16--70000-8}

8.1 The MMCO shall be responsible for its sound financial management in accordance with applicable professional standards. The MMCO shall:

8.1.1 Present to DHSS any information and records deemed necessary to determine its financial condition. The response to requests for information and records shall be delivered to DHSS, at no cost to DHSS, in a reasonable time from the date of the request or as specified therein.

8.1.2 Immediately notify DHSS when the MMCO has reason to consider insolvency or otherwise has reason to believe it or any of its subcontractors is other than financially sound and stable, or when financial difficulties are significant enough for the Chief Executive Officer or Chief Financial Officer to notify the MMCO's governing body of the potential for insolvency, and

8.1.3 Maintain a uniform accounting system that adheres to generally accepted accounting principles and generally accepted auditing standards for charging and allocating to all funding resources the MMCO’s costs incurred hereunder including, but not limited to, the American Institute of Certified Public Accountants Statement of Position 89-5 “Financial Accounting and Reporting by Providers of Prepaid Health Care Services.”

8.2 The MMCO shall contract with an independent licensed certified public accountant to conduct an annual financial audit of the MMCO, including but not limited to the financial transactions made under the Contract.

8.3 The MMCO shall notify DHSS within 10 calendar days if its contract with an independent auditor or actuary has changed or been terminated. The notification shall include the date of and reason for the change or termination. If the change or termination occurred as a result of a disagreement or dispute, the notification shall include the nature of the disagreement or dispute. In addition, the notification shall include the name of the replacement auditor or actuary, if any.

**History**
- *21 DE Reg. 568 (01/01/18)*
- *21 DE Reg. 568 (01/01/18)*
- *21 DE Reg. 568 (01/01/18)*
- *18 DE Reg. 693 (03/01/15)*
- *21 DE Reg. 568 (01/01/18)*

##### **16 Del. Admin. Code § 70000-9** Reserved Funds For Incurred But Not Reported Costs And Received But Unpaid Claims {#sec-70000-9 omnilex-key=us-de-regs-official--title-16--70000-9}

9.1 The MMCO shall establish and maintain an actuarially sound process for estimating and tracking incurred but not reported costs and received but unpaid claims. The MMCO shall reserve funds for each major category of service (e.g., hospital inpatient, physician, nursing facility) to cover both incurred but not reported and reported but unpaid claims. The MMCO shall conduct reviews, at least annually, to assess its reserving methodology and make adjustments deemed by DHSS to be necessary to the methodology.

**History**
- *21 DE Reg. 568 (01/01/18)*
- *21 DE Reg. 568 (01/01/18)*
- *21 DE Reg. 568 (01/01/18)*
- *18 DE Reg. 693 (03/01/15)*
- *21 DE Reg. 568 (01/01/18)*

##### **16 Del. Admin. Code § 70000-10** Inspection and Audit of Financial Records {#sec-70000-10 omnilex-key=us-de-regs-official--title-16--70000-10}

10.1 The MMCO shall meet all federal and state requirements with respect to inspection and auditing of financial records. The MMCO shall cooperate with DHSS or its authorized representative and provide all financial records, including but not limited to records of its subcontractors, related party agreements, and provider participation agreements as specified by DHSS so that DHSS or its authorized representative or the federal Department of Health and Human Services or its authorized representative may inspect and audit the MMCO’s financial records at least annually or at DHSS’s discretion.

10.2 The MMCO shall submit financial reports as described in the Financial Reporting Guide, which is incorporated by reference into this regulation.

**History**
- *21 DE Reg. 568 (01/01/18)*
- *21 DE Reg. 568 (01/01/18)*
- *21 DE Reg. 568 (01/01/18)*
- *18 DE Reg. 693 (03/01/15)*
- *21 DE Reg. 568 (01/01/18)*

##### **16 Del. Admin. Code § 70000-11** Decertification {#sec-70000-11 omnilex-key=us-de-regs-official--title-16--70000-11}

11.1 The MMCO shall at all times comply with the requirements set forth in the Contract. DHSS may immediately revoke the MCCO's certification upon termination of the Contract in accordance with its terms or as a result of a breach thereof by the MMCO, or upon the determination of DHSS that:

11.1.1 the MMCO has become financially unsound to the point of threatening the ability of DHSS to obtain the services provided for under the Contract,

11.1.2 the MMCO ceases to conduct business in the normal course,

11.1.3 the MMCO makes a general assignment for the benefit of creditors, or

11.1.4 the MMCO suffers or permits the appointment of a receiver for its business or its assets.

11.2 In the event of such decertification, DHSS shall notify the MMCO of the proposed decertification in accordance with 29 Del.C. §§10122 and 10131. If the MMCO requests a hearing on the proposed decertification, DHSS shall appoint a hearing officer to preside over the hearing.

11.3 Hearing procedures

11.3.1 At any hearing on the proposed decertification, the parties shall have the right to appear in person or be represented by counsel, or both. The parties shall have the right to produce evidence and witnesses on their behalf and to cross examine witnesses.

11.3.2 No fewer than 10 days prior to the date set for any hearing on the proposed decertification, the parties shall submit to the hearing officer a list of the witnesses they intend to call at the hearing. Witnesses not listed shall be permitted to testify only upon a showing of reasonable cause for such omission.

11.3.3 The hearing officer may administer oaths, take testimony, hear proofs and receive exhibits into evidence at any hearing. All testimony at any hearing shall be under oath.

11.3.4 Strict rules of evidence shall not apply. All evidence having probative value commonly accepted by reasonably prudent people in the conduct of their affairs shall be admitted.

11.3.5 An attorney representing a party in a hearing or matter before the hearing officer shall notify the hearing officer of the representation in writing as soon as practicable.

11.3.6 Requests for postponements of any matter scheduled before the hearing officer shall be submitted to the hearing officer in writing no fewer than three (3) days before the date scheduled for the hearing. Absent a showing of exceptional hardship, there shall be a maximum of one postponement allowed to each party to any hearing.

11.3.7 If the MMCO fails to appear at the decertification hearing after receiving the notice required by 29 Del.C. §10122 and 10131, the hearing officer may proceed to hear and determine the validity of the proposed decertification.

11.3.8 The hearing officer shall render a decision based solely on the evidence admitted at the hearing.

11.4 In the event of decertification, the MMCO shall be paid for any outstanding monies due less any assessed sanctions in accordance with the Contract.

**History**
- *21 DE Reg. 568 (01/01/18)*
- *21 DE Reg. 568 (01/01/18)*
- *21 DE Reg. 568 (01/01/18)*
- *18 DE Reg. 693 (03/01/15)*
- *21 DE Reg. 568 (01/01/18)*

#### **80000** Authorization and Regulation of Medicaid/CHIP Accountable Care Organizations

##### **16 Del. Admin. Code § 80000-1.0** Authority and Purpose {#sec-80000-1.0 omnilex-key=us-de-regs-official--title-16--80000-1.0}

1.1 This regulation is promulgated pursuant to Section 7931(e) of Title 29, Delaware Code.

1.2 Pursuant to 42 CFR 438.6(c)(1), states may require a Medicaid Managed Care Organization (MMCO) to implement value-based purchasing (VBP) models for provider reimbursement and to participate in Medicaid-specific delivery system reform initiatives.

1.3 Pursuant to 29 Del.C. §7931(c), the Division of Medicaid and Medical Assistance (“DMMA”), which is under the direction and control of the Secretary of the Department of Health and Social Services (“DHSS”), is responsible for the performance of all of the powers, duties, and functions specifically related to Medicaid. This includes regulation and administration of MMCO activity, such as contracting with Accountable Care Organizations (ACOs).

1.4 The purpose of these regulations is to set forth standards for the authorization and regulation of ACOs for Medicaid/CHIP beneficiaries in the State of Delaware to improve health outcomes while reducing costs through VBP arrangements which include downside financial risk for participating ACOs.

**History**
- *23 DE Reg. 659 (02/01/20)*

##### **16 Del. Admin. Code § 80000-2.0** Definitions {#sec-80000-2.0 omnilex-key=us-de-regs-official--title-16--80000-2.0}

“Accountable Care Organization” or “ACO” means a group arrangement in which health care practitioners (e.g., hospitals, physicians, other health care providers) agree to assume responsibility for the quality, outcomes and cost of health care for a designated group of Medicaid and/or CHIP beneficiaries.

“ACO Contract” means a contract formed between an ACO and an MMCO that includes payment via a value-based purchasing arrangement as defined by DHSS.

“ACO Requirements” means standards developed by DHSS outlining the qualifications needed for an ACO to participate in the program.

“Value-Based Purchasing” or “VBP” means a model for provider reimbursement that promotes value over volume, such as a shared savings or risk-based arrangement.

**History**
- *23 DE Reg. 659 (02/01/20)*

##### **16 Del. Admin. Code § 80000-3.0** Formation and Existence {#sec-80000-3.0 omnilex-key=us-de-regs-official--title-16--80000-3.0}

3.1 Each ACO seeking approval from DHSS shall demonstrate to the satisfaction of DHSS that:

3.1.1 The ACO is duly formed and validly existing under the laws of the State of Delaware.

3.1.2 The ACO has the necessary corporate or company power to perform its obligations under the ACO Requirements and to enter into ACO Contracts with MMCOs.

3.1.3 The ACO has taken all necessary corporate or company action to authorize the execution, delivery, and performance of ACO Contracts.

3.1.4 The execution and delivery of ACO Contracts, and the performance of the ACO’s obligations under the ACO Contract, will not result in a violation of any provision of the ACO’s certificate of incorporation, bylaws, or other governing instrument or document whether at the State or Federal level.

**History**
- *23 DE Reg. 659 (02/01/20)*

##### **16 Del. Admin. Code § 80000-4.0** Duties and Obligations {#sec-80000-4.0 omnilex-key=us-de-regs-official--title-16--80000-4.0}

4.1 Each ACO seeking approval from DHSS shall demonstrate to the satisfaction of DHSS that:

4.1.1 The ACO has an organizational/governance structure that will have sufficient authority to ensure the delivery of high quality, cost-effective care to its attributed Medicaid/CHIP members, as determined by DHSS.

4.1.2 The ACO has demonstrated the capability to offer a comprehensive array of coordinated primary care services, specialty care services, and the ability to provide access, either directly or through affiliations/contractual relationships, to behavioral health, acute care, community and social support, long term care, and oral health providers, and other organizations as determined by DHSS or as required in the ACO Contract.

4.1.3 The ACO has a plan to support care coordination across the continuum of care, including services that address health-related social needs, within and outside the ACO.

4.1.4 The ACO has an electronic health records (“EHR”) system in place and has the capability to exchange data with MMCOs and DHSS, and other designated entities such as the Delaware Health Information Network (DHIN).

4.1.5 The ACO has a plan in place to monitor, report, and improve patient health outcomes and quality.

4.1.6 The ACO attests that it will not limit beneficiary provider choice and access to providers that are outside the ACO.

4.1.7 Any additional requirements that DHSS determines necessary to meet the goals of improving health outcomes and patient experience, while reducing costs.

**History**
- *23 DE Reg. 659 (02/01/20)*

##### **16 Del. Admin. Code § 80000-5.0** Authorization {#sec-80000-5.0 omnilex-key=us-de-regs-official--title-16--80000-5.0}

5.1 If upon completion of its application, DHSS finds that the ACO has met the requirements therefor under this regulation, DHSS shall authorize the ACO to enter into an ACO Contract with the Delaware MMCOs for purposes of the Delaware Medicaid/CHIP managed care program.

5.2 DHSS’s authorization of an ACO shall be limited to the ACO’s business related to the Delaware Medicaid/CHIP managed care program and shall not authorize the ACO to conduct business that would otherwise require licensure under Title 18 of the Delaware Code.

5.3 The ACO shall at all times comply with the requirements set forth under this regulation. DHSS may immediately revoke the ACO’s authorization in accordance with its policies or as a result of a breach thereof by the ACO, or upon the determination of DHSS that the ACO is no longer able to meet the duties and obligations.

**History**
- *23 DE Reg. 659 (02/01/20)*

## **Department of Safety and Homeland Security** Department of Safety and Homeland Security

### **100** Office of the Secretary

#### **100** Regulations Governing Community Firearm Recovery Programs

##### **16 Del. Admin. Code § 100-1.0** Definitions {#sec-100-1.0 omnilex-key=us-de-regs-official--title-16--100-1.0}

The following words and terms, when used in this regulation, shall have the following meaning unless the context clearly indicates otherwise:

“Agency” means any local municipal police department, the New Castle County Police Department and the Delaware State Police.

“CFRP” means Community Firearm Recovery.

“DSHS” means Delaware Department of Safety and Homeland Security.

“Firearm” means any firearm as defined in Sec 222(12), Title 11, Delaware Code.

“Gift Card” means type of payment used by a police agency to pay for surrendered- firearms such as a VISA or MasterCard gift card.

“Pilot Period” means July 6, 2011 to May 15, 2012.

“Secretary” means the Secretary of Delaware Department of Safety and Homeland Security.

**History**
- *15 DE Reg. 319 (09/01/11) (Prop.)*

##### **16 Del. Admin. Code § 100-2.0** Application by Requesting Police Agency: {#sec-100-2.0 omnilex-key=us-de-regs-official--title-16--100-2.0}

2.1 Funds allocated pursuant to 16 Del.C. Ch. 104 shall be maintained in the DSHS, Office of the Secretary.

2.1.1 Administrative costs incurred pursuant to the recovery of the weapons, the purchase and redemption of gift cards, and, upon approval by the Secretary, publication and advertising of the CFRP event shall be reimbursable through the funds allocated under 16 Del.C. Ch. 104 and these regulations.

2.1.2 Administrative costs shall be requested by the police agency in advance of the CFRP event pursuant to section 2.3 of these regulations.

2.2 Request for funds:

2.2.1 An agency may participate in the CFRP and receive funds, upon approval by the Secretary, by submitting a letter of request, at least 14 days in advance of the event, indicating its desire to do so and stating the following:

2.2.1.1 The date, time, location and duration of the event;

2.2.1.2 Any civic and/or community organization participating in the event in collaboration or partnership withth the requesting agency;

2.2.1.3 The person in the requesting agency responsible for maintaining the funds and/or inventory allocated by DSHS as well as any funds and/or inventory contributed by sponsoring entities;

2.2.1.4 An estimate of firearms the requesting agency believes it will receive as a result of the CFRP event;

2.2.1.5 The estimated costs of publication and advertising; and,

2.2.1.6 The estimated costs to administer the program.

2.3 Agencies may, and are encouraged to, convert any funds received from DSHS for a CFRP event to gift cards redeemable for merchandise in the amounts stated in Sections 3.3 and 3.4 of these regulations, to the extent possible.

2.4 Within seven (7) days after the conclusion of the CFRP event, the police agency shall submit to the Secretary an accounting of all funds allocated by DSHS under these regulations.

2.5 All unused funds shall be returned to DSHS in the form of U.S. currency, check or money order within seven (7) days of the CFRP event.

**History**
- *15 DE Reg. 319 (09/01/11) (Prop.)*

##### **16 Del. Admin. Code § 100-3.0** Collection and Disposition of Recovered Firearms: {#sec-100-3.0 omnilex-key=us-de-regs-official--title-16--100-3.0}

3.1 Upon surrender, all firearms shall be tagged or marked by the collecting agency as to where collected, whom collected by, the date of collection, make, model and serial number.

3.2 All ammunition received shall be disposed of at the discretion of the host agency in accordance with their policies.

3.3 Funds shall be issued for firearms which, upon preliminary inspection, appear to be operational, in amounts not to exceed the following:

Assault Rifles

3.4 The agency shall have the discretion to pay an amount not to exceed $75.00 for parts of firearms and ammunition received during a CFRP event.

3.5 Within seven (7) business days after the conclusion of a CFRP event, a complete list of all firearms collected shall be supplied to the Secretary containing information listed in section 3.1 of these regulations.

3.6 It shall be the responsibility of the police agency holding a CFRP event to dispose of the firearms collected. Disposal may include any, or a combination, of the following;

3.6.1 Sale or transfer of firearms to a federal licensed dealer, (defined as a person licensed as a firearms collector, dealer, importer, or a manufacturer under the provisions of 18 U.S.C. section 922). The proceeds of any such sale shall be utilized by the agency for any law enforcement or charitable purpose as established by the agency conducting the CFRP event.

3.6.2 Destruction in a manner causing total destruction of the firearm through such methods as melting or shredding.

3.6.3 Return any firearms determined to be stolen to the rightful owner.

3.7 Agencies, upon disposition of firearms, shall furnish a list of all disposed firearms to the Secretary.

**History**
- *15 DE Reg. 319 (09/01/11) (Prop.)*

##### **16 Del. Admin. Code § 100-4.0** General Rules: {#sec-100-4.0 omnilex-key=us-de-regs-official--title-16--100-4.0}

4.1 An agency conducting a CFRP event shall be responsible for the security of the site, the surrounding area, the surrendered firearms, transportation of surrendered firearms and all unused funds and inventory.

4.2 To ensure safety, any agency conducting a CFRP event shall have at least one person on site knowledgeable in the operation and safety of firearms.

4.3 Any individual who elects to surrender a firearm anonymously at a CFRP event may do so and personal identification shall not be required to be presented at the time of the redemption.

**History**
- *15 DE Reg. 319 (09/01/11) (Prop.)*

#### **101** Regulations Governing the Relief from Disabilities Board

##### **16 Del. Admin. Code § 101-1.0** Purpose. {#sec-101-1.0 omnilex-key=us-de-regs-official--title-16--101-1.0}

1.1 To establish rules and regulations for the Relief from Disabilities Board, a forum for persons subject to the disabilities of 18 U.S.C. §§922(d)(4) and (g)(4) and/or of 11 Del.C. §1448(a)(2) because of an adjudication or commitment to seek relief from a firearms prohibition.

1.2 To provide proper and adequate due process to those persons seeking relief from a firearms prohibition arising strictly from a disability under 18 U.S.C. §§ 922(d)(4) and (g)(4) and/or 11 Del.C. §1448(a)(2).

1.3 To allow for the expeditious modification or correction of a person's record who is no longer subject to a firearms prohibition under 18 U.S.C. §§ 922(d)(4) and (g)(4) and/or 11 Del.C. §1448(a)(2).

1.4 To ensure the confidentiality and security of records and data provided pursuant to 11 Del.C. §1448A.

**History**
- *18 DE Reg. 649 (02/01/15)*
- *18 DE Reg. 649 (02/01/15)*
- *18 DE Reg. 649 (02/01/15)*
- *18 DE Reg. 649 (02/01/15)*
- *18 DE Reg. 649 (02/01/15)*
- *15 DE Reg. 1764 (06/01/12)*
- *18 DE Reg. 649 (02/01/15)*

##### **16 Del. Admin. Code § 101-2.0** Scope and Applicability {#sec-101-2.0 omnilex-key=us-de-regs-official--title-16--101-2.0}

2.1 Authority. These regulations are promulgated pursuant to 11 Del.C. §1448A(l). These regulations shall be known as "Regulations Governing the Relief from Disabilities Program and Use of Data Pursuant to 11 Del.C. §1448A".

2.2 Applicability. These regulations apply to persons who are prohibited from carrying, possessing, owning or transferring firearms as it relates to 18 U.S.C. §§ 922(d)(4) and (g)(4) and/or of 11 Del.C. §1448(a)(2) due to an adjudication or commitment to a hospital, mental institution or sanitarium as a result of a mental disorder.

**History**
- *18 DE Reg. 649 (02/01/15)*
- *18 DE Reg. 649 (02/01/15)*
- *18 DE Reg. 649 (02/01/15)*
- *18 DE Reg. 649 (02/01/15)*
- *18 DE Reg. 649 (02/01/15)*
- *15 DE Reg. 1764 (06/01/12)*
- *18 DE Reg. 649 (02/01/15)*

##### **16 Del. Admin. Code § 101-3.0** Definitions. {#sec-101-3.0 omnilex-key=us-de-regs-official--title-16--101-3.0}

The following words, phrases, and terms as used in these regulations shall have the meanings stated below:

"Adjudication or commitment to a hospital, mental institution or sanitarium as a result of a mental disorder" means a person admitted under a provisional admission by a psychiatrist or under a civil court order to the custody of the hospital for observation, diagnosis, care and treatment pursuant to 16 Del.C. Ch. 50. It does not include persons transported and held for mental health screening and assessment.

"Board" means the Relief from Disabilities Board hereby created by 11 Del.C. §1448A(k) and these regulations.

"Dangerous instrument" means any instrument, article or substance which is readily capable of cause death or serious physical injury as defined in 11 Del.C. §222(4).

"Deadly weapon" means any object which is or can be used, or attempted to be used, to cause death or serious physical injury as defined in 11 Del.C. §222(5).

"DELJIS" means the Delaware Criminal Justice Information System.

"Disability(ies)" means a prohibition from possessing, owning and/or transferring firearms as it relates to 11 Del.C. §1448(a)(2) and 18 U.S.C. §§ 922(d)(4) and (g)(4).

"DSCYFS" means the Department of Services for Children, Youth and Their Families.

"DHSS" means the Department of Health and Social Services.

"DSHS" means the Department of Safety and Homeland Security.

"Firearm" means any weapon as defined in 11 Del.C. §222(12).

"NICS" means National Instant Criminal Background Check System.

"Notice of De Novo Judicial Review" means written timely notice to the Superior Court and to the Board that a Petitioner, who has been denied relief after a hearing before the Relief from Disabilities Board, intends to appeal for a de novo review of the Board's decision by the Superior Court.

"Official record" means any and all documents, including but not limited to transcripts, evidence, testimony, etc., which has been submitted and presented to the Board for consideration during a hearing on a Petition for Relief.

"Person prohibited" means any person prohibited from purchasing, owning, possessing or controlling a deadly weapon or ammunition for a firearm within the State pursuant to 11 Del.C. §1448(a)(2) and 18 U.S.C. §§922(d)(4) and (g)(4).

**History**
- *18 DE Reg. 649 (02/01/15)*
- *18 DE Reg. 649 (02/01/15)*
- *18 DE Reg. 649 (02/01/15)*
- *18 DE Reg. 649 (02/01/15)*
- *18 DE Reg. 649 (02/01/15)*
- *15 DE Reg. 1764 (06/01/12)*
- *18 DE Reg. 649 (02/01/15)*

##### **16 Del. Admin. Code § 101-4.0** Confidentiality and Security of Data. {#sec-101-4.0 omnilex-key=us-de-regs-official--title-16--101-4.0}

4.1 The DHSS, DSHS, DSCYF and DELJIS shall adhere to 42 C.F.R. Part 2; 45 C.F.R. Parts 160, 162, and 164; and 16 Del.C. §1232 in protecting the confidentiality of protected patient health information in the use and discussion of protected patient health information and in the transmission of this information to the NICS database.

4.2 DELJIS shall adhere to 11 Del.C. Chapters 85 and 86 in protecting the confidentiality of criminal justice records and protected patient health information in the use of such information and in its transmission to the NICS database.

**History**
- *18 DE Reg. 649 (02/01/15)*
- *18 DE Reg. 649 (02/01/15)*
- *18 DE Reg. 649 (02/01/15)*
- *18 DE Reg. 649 (02/01/15)*
- *18 DE Reg. 649 (02/01/15)*
- *15 DE Reg. 1764 (06/01/12)*
- *18 DE Reg. 649 (02/01/15)*

##### **16 Del. Admin. Code § 101-5.0** Relief from Disabilities Board {#sec-101-5.0 omnilex-key=us-de-regs-official--title-16--101-5.0}

5.1 Creation.

5.1.1 The Relief from Disabilities Board is hereby created to carry out the functions and duties pursuant to 11 Del.C. §1448A(k) and these regulations.

5.1.2 The Board is authorized to consider petitions for relief pursuant to 11 Del.C. §1448A(k) and these regulations arising from mental health adjudications or commitments which occur in the State of Delaware.

5.1.3 All legal processes and all documents required by law to be served or filed with the Board shall be served or filed with the Chairperson of the Board at the Department of Safety and Homeland Security, 303 Transportation Circle, Dover, Delaware 19901.

5.1.4 Personal service or Service by Certified First Class Mail shall be considered proper service or filing.

5.1.5 Service shall be considered complete upon receipt by the Chairperson, or by a person authorized by the Chairperson to accept service, of a Notice of De Novo Judicial Review and all documents as required by section 5.2.2 of these regulations.

5.1.6 All official records of the Board or affidavits by the Chairperson as to the content of such records shall be prima facie evidence of all matters required to be kept by the Board.

5.1.7 The Board is not a designated agency pursuant to the Administrative Procedures Act and, therefore, shall be subject only to 29 Del.C. §10161(b).

5.1.8 The Board shall adhere to 42 C.F.R. Part 2; 45 C.F.R. Parts 160, 162, and 164; and 16 Del.C. §1232 in protecting the confidentiality of protected patient health information in the use and discussion of protected patient health information and in the transmission of this information to the NICS database.

5.1.9 Pursuant to 11 Del.C. §1448A(k), the Board shall be comprised of three (3) members, with the Chairperson appointed by and serving at the pleasure of the Secretary of Safety and Homeland Security and the remaining two (2) members appointed by and serving at the pleasure of the Secretary of the Department of Health and Social Services, one of whom shall be a Delaware licensed psychiatrist.

5.2 Procedure.

5.2.1 All three Board members must be present to hear a petition for relief and a simple majority shall constitute the decision of the Board.

5.2.2 The petition shall contain, at a minimum, the following:

5.2.2.1 The Petitioner's name, address and telephone number;

5.2.2.2 The Petitioner's mental health record;

5.2.2.3 A certificate from a medical doctor or psychiatrist licensed in this State that the person is no longer suffering from a mental disorder which interferes with or handicaps the person from handling deadly weapons and/or firearms;

5.2.2.4 A notarized affidavit signed by the Petitioner stating that the facts and statements contained in the petition are true and correct.

5.2.2.5 Any and all documents the Petitioner wishes to introduce or submit to the Board in support of his or her case.

5.2.3 The Board shall schedule a hearing on a petition for relief within 60 days from the date of receipt of the petition.

5.2.4 Pursuant to Sections 1.4 and 4.0 of these regulations, a petition for relief shall be heard by the Board in a closed and confidential hearing on the record.

5.2.4.1 The record of the hearing shall be maintained by the Chairperson at DSHS for a period of one year from the date of the hearing for purposes of de novo judicial review.

5.2.5 The Board shall consider evidence as specified in 11 Del.C. §§1448A(k)(2) and (3). In accordance with 11 Del.C. §1448A(k)(3), the Board may request that the petitioner undergo a clinical evaluation and risk assessment at the recommendation of the Board psychiatrist and if a majority of the Board agrees. The petitioner shall bear the costs of his or her clinical evaluation and/or risk assessment.

5.2.6 Relief shall be granted if the Board finds, by a preponderance of the evidence:

5.2.6.1 The Petitioner will not likely act in a manner dangerous to public safety; and,

5.2.6.2 Granting the relief will not be contrary to the public interest.

5.2.7 The decision of the Board shall be issued in writing explaining its reasons for a denial or grant of relief.

5.2.8 The decision of the Board shall be issued as soon as practicable following the hearing.

**History**
- *18 DE Reg. 649 (02/01/15)*
- *18 DE Reg. 649 (02/01/15)*
- *18 DE Reg. 649 (02/01/15)*
- *18 DE Reg. 649 (02/01/15)*
- *18 DE Reg. 649 (02/01/15)*
- *15 DE Reg. 1764 (06/01/12)*
- *18 DE Reg. 649 (02/01/15)*

##### **16 Del. Admin. Code § 101-6.0** Modification of Petitioner's Record. {#sec-101-6.0 omnilex-key=us-de-regs-official--title-16--101-6.0}

6.1 Upon notice that a petition for relief has been granted, the Department of Health and Social Services and the Department of Children, Youth and Their Families shall notify the Attorney General of the United States and shall update, correct, modify or remove from the database it maintains and makes available to NICS to reflect that the petitioner is no longer subject to a firearms prohibition as it relates to 11 Del.C. §1448(a)(2) and 18 U.S.C. §§ 922(d)(4) and (g)(4). Pursuant to 11 Del.C. §1448A(k)(7), DSHS shall be responsible for ensuring compliance with this regulation.

6.2 DELJIS shall also update, correct, modify or remove any reference to the petitioner's disability as it relates to 11 Del.C. §1448(a)(2) and 18 U.S.C. §§ 922(d)(4) and (g)(4) to reflect that the petitioner is no longer subject to a firearms prohibition under 11 Del.C. §1448(a)(2) and 18 U.S.C.§§ 922(d)(4) and (g)(4).

**History**
- *18 DE Reg. 649 (02/01/15)*
- *18 DE Reg. 649 (02/01/15)*
- *18 DE Reg. 649 (02/01/15)*
- *18 DE Reg. 649 (02/01/15)*
- *18 DE Reg. 649 (02/01/15)*
- *15 DE Reg. 1764 (06/01/12)*
- *18 DE Reg. 649 (02/01/15)*

##### **16 Del. Admin. Code § 101-7.0** De Novo Judicial Review of the Decision of the Board. {#sec-101-7.0 omnilex-key=us-de-regs-official--title-16--101-7.0}

7.1 Any person whose petition for relief has been denied by the Board shall have a right to a de novo judicial review in the Superior Court.

7.2 A petitioner shall file a Notice of De Novo Judicial Review in Superior Court within 30 days from the date the Board rendered its decision. The petitioner shall also file within 30 days of such decision a copy of the Notice of De Novo Judicial Review with the Board by serving the Chairperson, or a person designated to receive service on behalf of the Chairperson, at the Department of Safety and Homeland Security, 303 Transportation Circle, Dover, DE 19901.

7.3 The Board shall provide a copy and transcript of the record and hearing to the Superior Court within 30 days from its receipt of the copy of the Notice of De Novo Judicial Review.

7.4 The De Novo Judicial Review hearing shall be scheduled to be heard by the Superior Court within 30 days of receipt of the record and transcript of the Board hearing.

7.5 Pursuant to 11 Del.C. §1448A(k), the Superior Court shall consider the record of the Board hearing on the petition for relief, the decision of the Board, and, at the Court's discretion, any additional evidence it deems necessary to conduct its review.

7.6 The Superior Court shall issue its decision setting forth the basis to grant or deny the Petitioner's De Novo Judicial Review within a reasonable time after the De Novo Judicial Review hearing has been held. A copy of the Superior Court's decision shall be sent to the Petitioner and the Board.

7.7 If the Superior Court grants Petitioner's Notice of De Novo Judicial Review, the Board shall, as soon as practicable, notify DELJIS, DSCYF and DHSS, which shall update, correct, modify or remove any references to the person's disability from any database maintained and made available to NICS to reflect that the petitioner is no longer a person prohibited from owning, possessing and/or transferring firearms as it relates to 11 Del.C. §1448(a)(2) and 18 U.S.C. §§ 922(d)(4) and (g)(4). In addition, DHSS shall notify the Attorney General of the United States that the Petitioner is no longer subject to a firearms prohibition pursuant to 11 Del.C. §1448(a)(2), 18 U.S.C. §§ 922(d)(4) and (g)(4). Pursuant to 11 Del.C. §1448A(k)(7), DSHS shall be responsible for ensuring compliance with this regulation.

**History**
- *18 DE Reg. 649 (02/01/15)*
- *18 DE Reg. 649 (02/01/15)*
- *18 DE Reg. 649 (02/01/15)*
- *18 DE Reg. 649 (02/01/15)*
- *18 DE Reg. 649 (02/01/15)*
- *15 DE Reg. 1764 (06/01/12)*
- *18 DE Reg. 649 (02/01/15)*

#### **102** Regulations Governing the Destructive Weapon Compensation Program (DWCP)

##### **16 Del. Admin. Code § 102-1.0** Definitions {#sec-102-1.0 omnilex-key=us-de-regs-official--title-16--102-1.0}

The following words and terms, when used in this regulation, shall have the following meaning unless the context clearly indicates otherwise:

"Bump stock" means an after-market device that increases the rate of fire achievable with a semi-automatic rifle by using energy from the recoil of the weapon to generate a reciprocating action that facilitates repeated activation of the trigger.

"Destructive weapon" means a destructive weapon as described in 11 Del.C. §1444(a)(6).

"DSHS" means Delaware Department of Safety and Homeland Security.

“DWCP” means the Destructive Weapon Compensation Program.

"Gift card" means type of payment used by a law enforcement agency to pay for surrendered destructive weapons such as a VISA or MasterCard gift card.

"Law enforcement agency" means the Delaware State Police.

"Program period" means July 1, 2018 to June 30, 2019.

"Secretary" means the Secretary of Delaware Department of Safety and Homeland Security.

"Trigger crank" means an after-market device designed and intended to be added to a semi-automatic rifle as a crank operated trigger actuator capable of triggering multiple shots with a single rotation of the crank.

**History**
- *22 DE Reg. 307 (10/01/18)*

##### **16 Del. Admin. Code § 102-2.0** Authorization {#sec-102-2.0 omnilex-key=us-de-regs-official--title-16--102-2.0}

2.1 Funds allocated pursuant to 11 Del.C. §1444 shall be maintained in the DSHS, Office of the Secretary.

2.1.1 Funds will be distributed to the law enforcement agency locations in the form of gift cards or cash.

2.2 The Secretary will designate which law enforcement agency locations will participate in the DWCP.

2.2.1 An agency location designated to participate in the DWCP and receive funds shall make public notice upon designation by the Secretary, at least 14 days in advance of starting their program, indicating the following:

2.2.1.1 The dates, times, location and duration for collection;

2.2.1.2 The contact person for the DWCP responsible for maintaining the funds and/or inventory allocated by DSHS.

2.3 Within seven (7) days after the conclusion of the DWCP program period, the law enforcement agency shall submit to the Secretary an accounting of all funds allocated by DSHS under these regulations.

2.4 All unused funds shall be returned to DSHS in the form it was received, within seven (7) days of the conclusion of the DWCP program period.

**History**
- *22 DE Reg. 307 (10/01/18)*

##### **16 Del. Admin. Code § 102-3.0** Collection and Disposition of Recovered Destructive Weapon {#sec-102-3.0 omnilex-key=us-de-regs-official--title-16--102-3.0}

3.1 Upon surrender, all destructive weapons shall be tagged or marked by the collecting agency as to where collected, whom collected by, who collected from, the date of collection, make, model and serial number if applicable.

3.2 Funds shall be issued for destructive weapons which, upon preliminary inspection, appear to be operational, in amounts not to exceed the following:

3.3 The law enforcement agency shall not have the discretion to pay an amount exceeding the amounts as described in subsection 3.2 during the DWCP program period.

3.4 Within seven (7) business days after the conclusion of the DWCP program period, a complete list of all destructive weapons collected shall be supplied to the Secretary containing information listed in subsection 3.1 of these regulations.

3.5 It shall be the responsibility of the law enforcement agency participating in the DWCP to dispose of the destructive weapons collected. Disposal may include any, or a combination, of the following;

3.5.1 Destruction in a manner causing total destruction of the weapon through such methods as crushing, melting or shredding.

3.6 Agencies, upon destruction of weapons, shall furnish a list of all disposed destructive weapons to the Secretary within seven (7) business days.

**History**
- *22 DE Reg. 307 (10/01/18)*

##### **16 Del. Admin. Code § 102-4.0** General Rules {#sec-102-4.0 omnilex-key=us-de-regs-official--title-16--102-4.0}

4.1 An agency conducting a DWCP shall be responsible for the security of the site, the surrounding area, the surrendered destructive weapons, transportation, unused funds and inventory.

4.2 To ensure safety, any agency conducting a DWCP shall have at least one person on site knowledgeable in the operation and safety of firearms.

4.3 Any individual who elects to surrender a destructive weapon anonymously at a DWCP designated location may do so; however, the individual will not be eligible for compensation.

4.4 Personal identification showing proof of Delaware residency shall be required to be presented at the time of the redemption.

4.5 The DWCP is only intended for individuals and does not apply to wholesale, retail, manufacturers and distributor business entities.

4.6 Destructive weapons relinquished to a law-enforcement agency of the state as part of the DWCP may be destroyed by that agency 30-days after relinquishment.

4.7 Notwithstanding any law to the contrary, any person, provided the person is, in good faith, on an immediate, direct route to a designated law enforcement agency in the DWCP shall be immune from criminal prosecution for the criminal offenses defined in 11 Del.C. §1444.

**History**
- *22 DE Reg. 307 (10/01/18)*

#### **103** Regulations Governing the Delaware Large Capacity Magazine Compensation Program

##### **16 Del. Admin. Code § 103-1.0** Definitions {#sec-103-1.0 omnilex-key=us-de-regs-official--title-16--103-1.0}

The following words and terms, when used in this regulation, shall have the following meaning:

"DSHS" means Delaware Department of Safety and Homeland Security.

"Gift Card" means type of payment used by a law enforcement agency to pay for a surrendered large capacity magazine such as VISA or MasterCard gift card.

"Large capacity magazine" or "LCM" means as defined by 11 Del.C. § 1468(2) any ammunition feeding device capable of accepting, or that can readily be converted to hold, more than 17 rounds of ammunition. "Large-capacity magazine" does not include an attached tubular device designed to accept, and only capable of operating with, .22 caliber rimfire ammunition.

"Law Enforcement Agency" means the Delaware State Police.

"LCMCP" means the Delaware Large-Capacity Magazine Prohibition Act of 2022 Compensation Program described in 11 Del.C. § 1469(d).

"Secretary" means the Secretary of Delaware Department of Safety and Homeland Security.

**History**
- *26 DE Reg. 400 (11/01/22)*

##### **16 Del. Admin. Code § 103-2.0** Authorization {#sec-103-2.0 omnilex-key=us-de-regs-official--title-16--103-2.0}

2.1 Funds allocated pursuant to 11 Del.C. §1469(d)(1) shall be maintained in the DSHS, Office of the Secretary. Funds will be distributed to the law enforcement agency in the form of gift cards or cash.

2.2 The Secretary will designate which law enforcement agency locations will participate in the LCMCP.

2.2.1 An agency location designated to participate in the LCMCP and receive funds shall make public notice upon designation by the Secretary, at least 14 business days in advance of starting their program indicating the following:

2.2.1.1 The dates, times, location and duration of the collection.

2.2.1.2 The contact person for the LCMCP responsible for maintaining the funds or inventory allocated by DSHS.

2.3 Within 14 business days after the conclusion of the LCMCP period, the law enforcement agency shall submit to the Secretary an accounting of all funds allocated by DSHS under these regulations.

2.4 All unused funds shall be returned to DSHS in the form it was received, within 14 business days of the conclusion of the LCMCP period.

**History**
- *26 DE Reg. 400 (11/01/22)*

##### **16 Del. Admin. Code § 103-3.0** Collection and Disposition of Recovered Large Capacity Magazines {#sec-103-3.0 omnilex-key=us-de-regs-official--title-16--103-3.0}

3.1 Upon surrender, all LCM shall be tagged or marked by the collecting agency as to:

3.1.1 Where collected;

3.1.2 Whom collected by;

3.1.3 Who collected from;

3.1.4 The date of collection;

3.1.5 The make, model and serial number if applicable.

3.2 Funds shall be issued for LCM which, upon preliminary inspection, appear to be operational, in amounts not to exceed the following:

3.2.1 LCM 18 to 30 rounds: $15.00

3.2.2 LCM 31 or greater rounds:$25.00

3.2.3 LCM Drums: $80.00

3.3 The law enforcement agency shall not have the discretion to pay an amount exceeding the amounts as described in subsection 3.2 during the LCMCP period.

3.4 Within 14 days after the conclusion of the LCMCP period, a complete list of all LCM collected shall be supplied to the Secretary containing information listed in subsection 3.1 of these regulations.

3.5 It shall be the responsibility of the law enforcement agency participating in the LCMCP to dispose of the LCMs collected. Disposal may include any, or a combination of the following:

3.5.1 Destruction in a manner causing destruction of the LCM through such methods as crushing, melting or shredding.

3.6 Agencies, upon destruction of weapons, shall furnish a list of all disposed LCMs to the Secretary within 14 business days.

**History**
- *26 DE Reg. 400 (11/01/22)*

##### **16 Del. Admin. Code § 103-4.0** General Rules {#sec-103-4.0 omnilex-key=us-de-regs-official--title-16--103-4.0}

4.1 The LCMCP shall be completed by June 30, 2023. The LCMCP is subject to the availability of funds appropriated for this specific purpose by the General Assembly. The LCMCP does not create a right or entitlement in a resident to receive a monetary payment under the LCMCP.

4.2 An agency conducting an LCMCP shall be responsible for the security of the site, the surrounding area, the surrendered LCM, transportation, unused funds and inventory.

4.3 To ensure safety, any agency conducting an LCMCP shall have at least one person on site knowledgeable in the operation and safety of firearms.

4.4 Any individual who elects to surrender an LCM anonymously at an LCMCP designated location may do so; however, the individual will not be eligible for compensation.

4.5 Personal identification showing proof of Delaware residency shall be required to be presented at the time of the redemption.

4.6 The LCMCP is only intended for individuals and does not apply to wholesale, retail, manufacturers and distributor business entities.

4.7 An LCM relinquished to a law-enforcement agency of the state as part of the LCMCP may be destroyed by the agency 30 days after relinquishment.

4.8 Notwithstanding any law to the contrary, any person, provided the person is, in good faith, on an immediate, direct route to a designated law enforcement agency in the LCMCP shall be immune from criminal prosecution for the criminal offenses defined in 11 Del.C. §1469.

**History**
- *26 DE Reg. 400 (11/01/22)*

### **200** Division of Communications

#### **200** In-Building Communications Systems Regulation

##### **16 Del. Admin. Code § 200-1.0** Scope and Purpose {#sec-200-1.0 omnilex-key=us-de-regs-official--title-16--200-1.0}

1.1 These rules and regulations ensure the quality of the State’s emergency communications system by maintaining quality in-building communications to prevent “dead zone” areas and helping to protect the citizens of the State so emergency public safety personnel can communicate during a response to an emergency situation.

1.2 These rules and regulations apply to all newly constructed buildings of 25,000 square feet or more.

**History**
- *14 DE Reg. 1238 (05/01/11)*

##### **16 Del. Admin. Code § 200-2.0** Definitions {#sec-200-2.0 omnilex-key=us-de-regs-official--title-16--200-2.0}

“Contiguous structures” shall mean two structures that share a common wall or floor.

“Newly constructed buildings” shall not be construed as a renovation or modification of a building, or an expansion or addition to a building which is contiguous to an existing building.

**History**
- *14 DE Reg. 1238 (05/01/11)*

##### **16 Del. Admin. Code § 200-3.0** In-Building System Architectures: {#sec-200-3.0 omnilex-key=us-de-regs-official--title-16--200-3.0}

Systems can consist of, but are not limited to, simple passive systems or an internal antenna system with or without FCC certified Bi-Directional Amplifiers for multiple-band, multiple-carrier use.

**History**
- *14 DE Reg. 1238 (05/01/11)*

##### **16 Del. Admin. Code § 200-4.0** Interference: {#sec-200-4.0 omnilex-key=us-de-regs-official--title-16--200-4.0}

If a flaw in the system design causes interference to other systems the building owner or their representative will make necessary adjustments.

**History**
- *14 DE Reg. 1238 (05/01/11)*

##### **16 Del. Admin. Code § 200-5.0** Alarm and Control: {#sec-200-5.0 omnilex-key=us-de-regs-official--title-16--200-5.0}

5.1 Systems shall be capable of sensing a primary failure in the system, and reporting this failure to an approved monitoring company via auto-dialer devices over the public switched network. The alarm unit shall provide reporting, at a minimum, for the following conditions:

5.1.1 Main power disruption

5.1.2 Back-up power failure

5.1.3 Transmitter/Receiver failure

5.2 The monitoring company must notify DE State Police Communication Headquarters at 302-659-2341 in the event of a BDA alarm.

**History**
- *14 DE Reg. 1238 (05/01/11)*

##### **16 Del. Admin. Code § 200-6.0** Power Source: {#sec-200-6.0 omnilex-key=us-de-regs-official--title-16--200-6.0}

6.1 All systems shall be connected to a dedicated power source from the building’s AC power distribution panel.

6.2 If any part of the installed system or systems contains an electrically powered component, the system shall be capable of operating on an independent battery and/or generator system for a period of at least two (2) hours without external power input. The battery system shall automatically charge in the presence of external power input.

6.3 In the event that a bi-directional amplifier is employed, it shall be fully encased within a NEMA 4 (or equivalent) dust/waterproof case.

**History**
- *14 DE Reg. 1238 (05/01/11)*

##### **16 Del. Admin. Code § 200-7.0** Environmental Controls: {#sec-200-7.0 omnilex-key=us-de-regs-official--title-16--200-7.0}

7.1 Systems must have adequate environmental controls to meet the heating, ventilation, cooling and humidity requirements of the equipment that will be utilized to meet the coverage requirements.

7.2 All systems, cables and antenna systems shall be grounded with a single point ground system of five (5) ohms or less.

7.3 System transient suppression for the telephone circuits, ac power, radio frequency (RF) cabling are required.

**History**
- *14 DE Reg. 1238 (05/01/11)*

##### **16 Del. Admin. Code § 200-8.0** Initial Coverage Testing and Acceptance: {#sec-200-8.0 omnilex-key=us-de-regs-official--title-16--200-8.0}

8.1 Initial testing and acceptance will be completed as described in Appendix A

8.2 A copy of the test shall be retained on the inspected premises. (Official testing form can be found within Appendix A.)

8.3 A copy of the test shall be sent to:

State of Delaware

Division of Communications

3050 Upper King Rd.

Dover, DE 19904

**History**
- *14 DE Reg. 1238 (05/01/11)*

##### **16 Del. Admin. Code § 200-9.0** Annual Test: {#sec-200-9.0 omnilex-key=us-de-regs-official--title-16--200-9.0}

9.1 When an in-building system is installed, the building owner or their representative shall test all active components of the system, including, but not limited to, the amplifier, power supplies, and back-up batteries, a minimum of once every twelve (12) months. Annual testing will include:

9.1.1 Amplifiers shall be tested to ensure that the gain is the same as it was upon initial installation and acceptance.

9.1.2 Back-up batteries and power supplies shall be tested under load for a period of one hour to verify that they will operate during an actual power outage.

9.1.3 All other active components shall be checked to determine that they are operating within the manufacturers specifications for their intended purposes.

9.2 Sampling Coverage Test – A transmit / receive coverage testing of 10% of the building grid will be required. Tests will be conducted in a different area of the building each year so that every 10 years the building has been completely tested. The testing area must be spread out throughout the building randomly. In that way, we are testing every amplifier in the system.

9.2.1 Test results tabulation form is attached.

9.2.2 Test results must be completed within 30 days of the previous annual inspection.

9.3 A copy of the test shall be retained on the inspected premises.

9.4 A copy of the test shall be sent to:

State of Delaware

Division of Communications

3050 Upper King Rd.

Dover, DE 19904

**History**
- *14 DE Reg. 1238 (05/01/11)*

##### **16 Del. Admin. Code § 200-10.0** Testing Authority: {#sec-200-10.0 omnilex-key=us-de-regs-official--title-16--200-10.0}

All tests shall be conducted, by a company or technician with a valid FCC license or equivalent, for two-way radio.

**History**
- *14 DE Reg. 1238 (05/01/11)*

##### **16 Del. Admin. Code § 200-11.0** Fire Department Inspections: {#sec-200-11.0 omnilex-key=us-de-regs-official--title-16--200-11.0}

Fire Department personnel or their designated representatives, after providing reasonable notice (24 hours) to the owner or representative, shall have the right during normal business hours to enter onto the property to verify compliance and that the required level of coverage is present. This inspection will be performed at no cost to the owner. Any noted deficiencies shall be provided in an inspection report to the owner or the owner’s representative.

**History**
- *14 DE Reg. 1238 (05/01/11)*

##### **16 Del. Admin. Code § 200-12.0** Temporary Certificate of Occupancy {#sec-200-12.0 omnilex-key=us-de-regs-official--title-16--200-12.0}

A recommendation for temporary (CofO) Certificate of Occupancy may be issued in the event that initial coverage testing fails. To receive a consideration for a temporary Certificate of Occupancy the facility owner must submit a plan of corrective action to the Delaware Division of Communications.

**History**
- *14 DE Reg. 1238 (05/01/11)*

##### **16 Del. Admin. Code § 200-13.0** Maintenance Responsibilities: {#sec-200-13.0 omnilex-key=us-de-regs-official--title-16--200-13.0}

The owner or their representative shall be responsible for maintenance of the system and upgrades or replacements should the system fail or no longer work in the future.

**History**
- *14 DE Reg. 1238 (05/01/11)*

##### **16 Del. Admin. Code § 200-14.0** Effective Date {#sec-200-14.0 omnilex-key=us-de-regs-official--title-16--200-14.0}

Coverage/Acceptance Test Plan

For Original Installation

Test Plan Overview:

The purpose of this test plan is to determine if newly constructed buildings in excess of 25,000 square feet have been designed and/or constructed so that emergency personnel can send and receive communications from within all areas of those buildings; or alternately, to verify the performance of buildings equipped with emergency communications equipment (i.e., radiating cable, passive antennas, bi-directional amplifiers, distributed antenna systems) so that emergency personnel can send and receive communications from all areas within the building.

A Grid Acceptance Test (GAT) will be used to demonstrate that the required reliability of communication is provided among 95% of the total number of grid cells at a Delivered Audio Quality (DAQ) of 3.4., (i.e., speech understandable with repetition only rarely required. Some Noise/Distortion).

Terms and testing methodology described within the GAT are based on the Telecommunications Industry Association (TIA) Telecommunications Systems Bulletin TSB-88-B, “Wireless Communications System - Performance in Noise and Interference-Limited Situations - Recommended Methods for Technology - Independent Modeling, Simulation, and Verifications.”

Grid Acceptance Test:

1. The Facility Owner is responsible to have a Grid Acceptance Test (GAT) prior to requesting a certificate of occupancy (C of O).

2. The GAT shall be performed by an Approved Vendor (AV).

3. The approved vendor shall be responsible to submit the results of the GAT directly to the Division of Communications.

4. If the facility has passed the GAT or the Division of Communications determines that the facility is worthy of a Temporary Certificate of Occupancy (TCO), the Division of Communications shall forward an approval form to the responsible Building Code Official (BCO) with the Division of Communications approval.

5. If the Division of Communications issued a TCO approval, the facility owner will be required to submit a passed GAT to the Division of Communications prior to the Building Code Official issuing a C of O.

Comment:

The test will be conducted after exterior walls, roofs, windows and doors have been constructed/installed and all interior rooms, their walls and ceilings, are in place and doors have been hung as appropriate for the C of O application being sought i.e., shell & core or complete tenant fitout.

The test will be conducted using portable radios which operate on the State of Delaware’s Emergency Radio Communications System.

The test team will verify that the test radios are functioning properly and meet minimum manufacturer’s performance standards prior to test execution.

All tests will be performed using a lapel microphone with the portable radio/antenna installed in a standard swivel case mounted on the hip belt with the operator remaining stationary during the test.

The building floor plan for all floors shall be overlaid with a uniform test grid. The test grid shall be established with each grid unit measuring 25 ft. by 25 ft. Each grid unit (cell) shall be uniquely identified and the results will be recorded in the Grid Acceptance Test Log (GAT Log). The grid map must be attached to the grid acceptance test log.

Grids in areas where electromagnetic interference (EMI’s) will interfere with the efficient operation of equipment sensitive to EMI’s will be excluded from the test and reliability calculations. When determining the coverage percentage, the total number of grids to be tested will be based on the total number of grids in a building minus the number of grids in EMI areas.

Stairwells, elevators and holding/jail cells are critical areas where Communication on both forward and reverse (transmit Tx & Receive Rx) paths must meet or exceed the DAQ 3.4 level to pass the requirements of this test. If an elevator or holding/jail cell falls in a grid area the grid and elevator or holding/jail cell will be tested separately. The test results for elevators and holding/jail cells are not included in the calculation for coverage determination.

When acceptance testing is performed in elevators, the internal and external doors shall be closed, and the test will be repeated on each floor. Tests in holding/jail cells shall be performed with the door to the cell in the closed and locked position.

The test procedure shall require the quality of communication to be judged by a stationary tester and mobile tester while the mobile tester move from grid unit (cell) to grid unit (cell), throughout the building, covering all grid units (cells) on all floors. The procedure has the following attributes:

CP = (TP)/(TC) x 100%

Note: CP is a function of the Pass/Fail results for each grid unit tested within the building, not the ratio of successful calls to unsuccessful calls within each specific grid unit.

Emergency Radio Communications System

In-Building Coverage

System Frequencies

Note: TX is the specific frequencies transmitted from the State of Delaware to be received inside the building.

RX is the specific frequencies received by the State of Delaware to be transmitted inside the building.

*NOTE – These frequencies are pre rebanding and will change 15MHz once rebanding is complete it is estimated that rebanding in DE will be completed by YE2011.

Emergency Radio Communications System

In-Building Coverage

For Informational Purposes Only

Request for Proposals/Equipment specifications

The building owner and/or owner’s representative shall request services to design, install, test and make operational an in-building Communications System (the “System” -- including, but not limited to, radiating cable, passive antennas, bi-directional amplifiers, and distributed antenna systems) on all levels of the building. The implementation of the System shall require work throughout all floors, including levels below grade, and shall result in a specified, minimum level of signal strength on all floors of the building, as well as the ability to successfully transmit and receive using typical hand-held audio transceivers used by the State of Delaware. The minimum acceptable signal strength and ability to successfully communicate shall be achieved 95% of the time and, with certain exceptions, among 95% of the 25’ X 25’ cells into which each floor is divided for testing and validation purposes. As part of the scope of work, the building owner and/or owner’s representative and the contractor shall identify specific, critical areas on each floor that shall be required to have the minimum acceptable level of signal strength at all times as long as the System and external (to the building) Emergency Communications System are operational. These critical areas shall include, but shall not be limited to, all stairwells, elevators and holding/jail cells.

1. The contractor shall participate in interviews with appropriate representatives of the owner to identify critical areas of the building on all levels that will be required to have an acceptable level of 800 MHz signal strength and signal propagation characteristics 100% of the time as long as the System and external (to the building) Emergency Communications System are functioning. The areas shall be identified as specific cells identified in Attachment C that are used for system testing and validation purposes and shall be referred to as “critical cells.”

2. The contractor shall evaluate the building drawings, 25’ X 25’ cell layout, location of critical cells noted in paragraph 1, frequencies used by the State of Delaware (see Attachment A), minimum equipment specifications, rules and regulations (see Attachment B), and established specifications for signal strength and voice transmission criteria (see Attachment C) to engineer the placement of all equipment and antennas on all floors of the building.

3. The contractor shall specify all equipment and cable to be used to implement the system, installation locations, power requirements, interconnections to other systems, schematic wiring diagrams and a plan of installation. The plan of installation may be divided into multiple phases that will enable portions of the system to be installed, tested, validated and activated in sequential fashion.

4. The contractor shall present its design for the System to the owner’s representative for approval prior to the start of work. The owner’s representative shall not unreasonably withhold approval, but the owner’s representative may request information from the contractor concerning the engineering assumptions on which the system design is based, and may require the contractor to make reasonable changes to its design before approval to proceed is granted.

5. Once the System design is approved by the owner’s representative, the contractor may proceed with the acquisition of supplies and materials, the installation of wiring, cabling, equipment and antennas, and the testing and validation of each phase of the System.

Deliverables:

1. Drawings of each floor of the building that are divided into 25’ by 25’ cells and note the critical cells identified through interviews with appropriate personnel identified by the owner’s representative.

2. A proposed System design that shows the location of all equipment, interconnections to other systems, power sources, proposed cabling routes and the location of all distribution antennas.

3. A final, approved System design that shows the location of all equipment, interconnections to other systems, power sources, cabling routes and the location of all distribution antennas.

4. All goods, materials, equipment, supplies, services and labor required to install, implement, test and validate the operation of the System according to the approved design noted in paragraph 3.

5. Completed test and System validation reports specified in Attachment “C.” A completed set of test and validation reports shall be required at the completion of each phase of system installation.

6. As-built drawings of the entire System at the completion of the project.

Warranty:

The contractor warrants that the signal strength and the ability to acceptably communicate according to the test procedures noted in Attachment “C” shall be at or above minimum acceptable levels in 95% of the 25’ X 25’ test cells into which each floor of the building is divided 95% of the time with the following exceptions:

The contractor shall warrant all materials, labor and workmanship for a period of at least one-year from the date the testing and validation report for the final phase of installation is accepted by the owner’s representative. The contractor shall warrant all materials and components for a period of at least one-year unless the manufacturer provides a longer warrantee period. If so, the contractor warrantee shall continue until the manufacturer’s warrantee has expired. The warrantee shall include all components of the in-building System installed on each floor (including components located on the roof and cabling between the roof and lower levels).

Information to be included in the Bidder’s Proposal:

1. A description of the Bidder’s experience and abilities as it relates to in-building RF systems.

2. A description of other similar projects completed within the last two years. Include project description, scope, outcome, cost and a contact name and phone number.

3. Business references including name, telephone number and relationship to bidder.

4. Project methodology including a description and technical overview for the proposed installation of the System. Include diagrams, schematics, a list of proposed equipment, power requirements and proposed interconnections to the existing system.

5. Project price as proposed.

6. An implementation plan including phases of work and time required to complete the project.

7. A price for an annual service contract for the System to be effective one year after the date that the owner’s representative accepts the testing and validation report for the last phase of installation. Pricing shall include an escalation factor to be used to calculate the cost of annual service agreements for a period of four additional years beyond the first year service agreement. Include a description of the service agreement and a proposed list of services and responsibilities.

**History**
- *14 DE Reg. 1238 (05/01/11)*