title-64•Title 64 W. Va. C.S.R.
Health Health
Series 01 Rules Of Procedure For Contested Case Hearings And Declaratory Rulings
W. Va. Code R. § 64-1-1 General
1.1. Scope. -- These procedural rules establish the general procedures for conducting contested case hearings and the issuance of declaratory rulings. The purpose of these rules is to facilitate the resolution of contested cases in a just, speedy, and inexpensive manner and to provide for declaratory rulings in accordance with W. Va. Code §29A-4-1.
1.2. Authority. -- W. Va. Code §§16-1-4, §29A-5-1(a) and 29A-4-1.
1.3. Filing Date. -- December 30, 2010.
1.4. Effective Date. -- January 30, 2011.
W. Va. Code R. § 64-1-2 Application
2.1. These procedural rules shall apply to every person, partnership, association, corporation or public corporation affected by any rules, regulations or statutes enforceable by the bureau for public health. These rules of procedure shall not apply to contested case hearings arising under the authority of W. Va. Code §16-2D-1, et seq.
W. Va. Code R. § 64-1-3 Definitions
3.1. Bureau – The Bureau for Public Health in the Department of Health and Human Resources.
3.2. Commissioner – The Commissioner of the Bureau for Public Health or his or her designee.
3.3. Event or occurrence - The written agency action that precipitates a request for a hearing.
W. Va. Code R. § 64-1-4 Hearings
4.1. Request for Hearing; Form Required - Any party who requests a hearing to determine any constitutional rights, legal rights, duties, interests or privileges of specific parties as required by law shall specify in writing the relief requested and the grounds relied upon as a basis for the relief requested.
4.2. Hearing on Written Request - When the Commissioner is presented with a request for a hearing as described in subsection 4.1. of this section he or she shall conduct a hearing within forty-five (45) days of receipt of such written request, unless postponed to a later date by mutual agreement.
4.3. A request for a hearing may be denied if the Commissioner determines that the hearing:
4.3.a. Involves an exercise of authority in excess of that available under law;
4.3.b. Would serve no useful purpose; or
4.3.c. Arises out of an event or occurrence that happened more than ninety (90) days prior to the request for a hearing.
4.4. If the Commissioner determines that the request for a hearing should be denied under section 4.3. of this rule, then the Commissioner shall, within twenty (20) days of the receipt of such request, enter an Order denying the request for hearing, including the reason for such denial. Appeal may be taken from such Order as provided in W. Va. Code §29A-5-4.
4.5. Notice of Hearing - Upon the receipt of a request for a hearing as described in subsection 4.1. of this Section, the Commissioner shall within twenty (20) days provide the party making such request with a notice of hearing providing the Commissioner has not entered an Order denying a hearing as provided in subsections 4.3. and 4.4. of this section. Such notice shall contain:
4.5.a. The date, time and place of the hearing;
4.5.b. A short plain statement of the matters asserted; and
4.5.c. A statement of intention to appoint a hearing examiner, if one is to be appointed pursuant to Section 8 herein; such notice shall be given at least 10 days in advance of the date of the hearing.
4.6. How Hearings Conducted - Hearings shall be conducted as follows:
4.6.a. Any party shall have the right to be represented by an attorney qualified to practice in the state of West Virginia;
4.6.b. The bureau may be represented by the office of the attorney general;
4.6.c. The rules of evidence as applied in civil cases in the circuit courts of this state shall be followed;
4.6.d. When necessary to ascertain facts not reasonably susceptible to proof under said rules of evidence, evidence not admissible thereunder shall be admitted, except where precluded by statute, if it is of a type commonly relied upon by reasonably prudent people in the conduct of their affairs;
4.6.e. The bureau shall be bound by the rules of privilege recognized by law;
4.6.f. Documentary evidence may be received in the form of copies or excerpts or by incorporation of reference;
4.6.g. Initially the bureau shall be given an opportunity to present evidence, including testimony, papers, records, bureau staff memoranda and documents in the possession of the bureau which it selects and determines to be in support of its position;
4.6.h. Every party shall have the right of cross-examination of witnesses who testify, and following the conclusion of the bureau’s presentation, shall have the right to present evidence including testimony, papers and records and to submit rebuttal evidence;
4.6.i. The bureau shall have the right to cross-examine witnesses providing rebuttal testimony; and
4.6.j. Following the presentation of all the evidence, every party, including the bureau , shall have the right to offer closing argument, not to exceed a reasonable time limit as determined by the Commissioner or the hearing examiner.
W. Va. Code R. § 64-1-5 Continuation and Adjournment
Hearings may be continued from one day to another or adjourned to a later date or a different place by announcement thereof by the hearing examiner at the hearing or by appropriate notice to all parties. A written motion for a continuance shall be filed and received by the bureau and the hearing examiner at least five (5) days prior to the hearing date.
W. Va. Code R. § 64-1-6 Transcription of Reported Testimony and Evidence
6.1. What Reported - All testimony, evidence, arguments, and rulings on the admissibility of testimony and evidence shall be reported by stenographic notes and characters or by mechanical means.
6.2. Request from any Party - Upon the request to the bureau from any party to the hearing, all reported materials shall be transcribed and a copy thereof furnished to such party at his or her expense.
6.3. Transcription in the Event a Hearing Examiner is Appointed - In all cases where a hearing examiner is appointed, all reported material shall be transcribed and forwarded to the Commissioner. Any parties requesting a copy of a transcript prepared pursuant to this subsection shall be furnished a copy at their expense.
6.4. Responsibility for Transcript - The bureau shall have the responsibility for making arrangements for the transcription of the reported testimony and evidence. In the event transcription is required pursuant to this section it shall be accomplished with all dispatch.
6.5. Correction of Error in Transcript - Upon the motion of the bureau or any party assigning error or omission in any part of any transcript, the bureau, through the Commissioner or duly appointed hearing examiner shall settle all differences arising as to whether such transcript truly discloses what occurred at the hearing and shall direct that the transcript be corrected and revised in the respects designated, so as to make it conform to the whole truth.
W. Va. Code R. § 64-1-7 Submission of Proposed Findings of Fact and Conclusions of Law; Time for Submission
Any party, including the bureau, may submit to the hearing examiner or administrative law judge proposed findings of fact and conclusions of law within thirty (30) days of the conclusion of a hearing or, on a time frame to be agreed upon by the parties and by the hearing examiner. In the event the proceedings of a hearing are transcribed, then the parties may submit proposed findings of fact and conclusions of law within twenty (20) days from the date the final transcript is available.
W. Va. Code R. § 64-1-8 Appointment of Hearing Examiner; Function of Hearing Examiner
The Commissioner may, in his or her discretion, appoint a hearing examiner who shall be empowered to subpoena witnesses and documents, administer oaths and affirmations, to examine witnesses under oath, to rule on evidentiary questions, to hold conferences for the settlement or simplification of issues by consent of the parties and to conduct hearings as provided in section 4 herein.
W. Va. Code R. § 64-1-9 Conferences; Informal Disposition of Cases
9.1. At any time prior to the hearing or thereafter but prior to the issuance of a final decision, the Commissioner, or his or her duly appointed hearing examiner may hold conferences:
9.1.a. To dispose of procedural request or similar matters;
9.1.b. To simplify or settle issues by consent of the parties; or
9.1.c. To provide for the informal disposition of cases by stipulation, agreed settlement, or consent order.
9.2. The Commissioner, or his or her duly appointed hearing examiner may cause such conferences to be held on his or her own motion or at the request of a party.
W. Va. Code R. § 64-1-10 Depositions Permitted
Evidentiary depositions may be taken and read into evidence only as allowed in the rules of civil procedure as in civil actions in the circuit courts of this state.
W. Va. Code R. § 64-1-11 Subpoenas
11.1. Where Permitted by Chapter 16 - In accordance with any provision contained in Chapter 16 of the West Virginia Code, authorizing the Commissioner to issue subpoenas or subpoenas duces tecum, the Commissioner or his or her duly appointed hearing examiner shall have the power to issue subpoenas or subpoenas duces tecum pursuant to the provisions set forth in W. Va. Code §29A5-1(b).
11.2. Time for Requesting the Issuance of Subpoenas - Written requests for the issuance of subpoenas or subpoenas duces tecum as provided in subsection 11.1. of this section shall be made no later than 10 days prior to a scheduled hearing.
W. Va. Code R. § 64-1-12 Orders, Content
Every final order entered by the hearing examiner or administrative law judge, following a hearing conducted pursuant to these rules, shall be made pursuant to the provisions of W. Va. Code §29A-5-3. Such orders shall be entered within forty-five (45) days following the submission of all documents and materials necessary for the proper disposition of the case, including transcripts and proposed findings of fact and conclusions of law.
W. Va. Code R. § 64-1-13 Declaratory Ruling - Procedures
13.1. On petition of any interested person, the Commissioner may issue a declaratory ruling with respect to the applicability to any person, property or state of facts of any rule, regulation or statute enforceable by the bureau.
13.2. Any interested person shall petition the Commissioner in writing, succinctly stating the issues upon which the declaratory ruling is requested.
13.3. Upon receipt of such petition, the Commissioner may cause a hearing to be held for the presentation of arguments and evidence within thirty (30) days of receipt of such petition. The Commissioner shall notify the parties thereto and set a time, a place, and a date for such hearing.
13.4. A declaratory ruling issued after argument and stated to be binding shall be binding between the bureau for public health and the petitioner on the state of facts alleged, unless altered or set aside by a court in accordance with W. Va. Code §29A-1-2. Furthermore, such declaratory ruling shall not be binding on any other person.
13.5. A declaratory ruling issued upon petition, proper notice and argument shall not preclude the petitioner from seeking a contested case hearing in accordance with the provisions of these Rules of Procedure for Contested Case Hearings and Declaratory Rulings. Such declaratory ruling shall serve only to explain or to elucidate the applicability to any person, property, or state of facts or any rule or statute enforceable by the bureau for public health.
W. Va. Code R. § 64-1-14 Appeal
Appeal - an appeal from any final order or ruling entered in accordance with this rule shall be in accordance with the provisions of W. Va. Code §29A-5-4.
Series 03 Public Water Systems
W. Va. Code R. § 64-3-1 General
1.1. Scope. -- This legislative rule establishes state standards and procedures and adopts national drinking water standards for public water systems and public water utilities. It establishes standards for the production and distribution of bottled drinking water, and also adopts federal standards for the certification of laboratories performing analyses of drinking water. This rule should be read in conjunction with W. Va. Code §16-1-9, §16-1-9a, §16-1-9c, and §16-1-9d.
1.2. Authority. -- W. Va. Code §16-1-4, §16-1-9, §16-1-9a, §16-1-9c, and §16-1-9d.
1.3. Filing Date. -- May 8, 2025.
1.4. Effective Date. -- July 1, 2025.
1.5. Sunset Provision. -- This rule shall terminate and have no further force or effect on August 1, 2030.
W. Va. Code R. § 64-3-2 Application and Enforcement
2.1. Application. – This rule applies to public drinking water systems, public water utilities, to bottled water treatment plants and distributors, and to laboratories desiring certification to perform analytic tests of drinking water.
2.2. Enforcement. – This rule is enforced by the Commissioner of the Bureau for Public Health or his or her designee.
W. Va. Code R. § 64-3-3 Definitions
3.1. “Bottled water” means all water which is sealed in bottles, packages, or other containers and offered for sale for human consumption, including bottled mineral water.
3.2. “Bottled water distributor” means a person who buys and sells bottled water on a wholesale basis.
3.3. “Bureau” means the Bureau for Public Health in the Department of Health.
3.4. “Commissioner” means the Commissioner of the Bureau for Public Health or his or her designee.
3.5. “Conjunctive delineation” means the integrated delineation of the ground water contribution area and the surface water contribution area for a public water system.
3.6. “Demonstration of Capability (DOC)” means before analyzing compliance samples, an analytical team shall demonstrate acceptable precision, accuracy, sensitivity, and specificity for the method to be used, as described in the referenced document in subdivision 13.2.1. of this rule.
3.7. “Department” means the West Virginia Department of Health.
3.8. “Hydrologic Unit Code (HUC)” means the basic unit of an ordered grouping of watersheds and sub-watersheds that make up the entire drainage network of the United States. This drainage network was developed by the United States Geological Survey. Each watershed is assigned a unique identification code based on its location and relationship with surrounding watersheds. The hydrologic unit identification code is a number consisting of between two to 17 digits depending on factors specific to each watershed. In West Virginia, most major river basins have been assigned one or more eight-digit hydrologic unit codes. Each of these eight-digit hydrologic units has been further divided into smaller watersheds identified by 11-, 14-, and 17-digit hydrologic unit codes.
3.9. “Ohio River Valley Water Sanitation Commission (ORSANCO)” means an interstate water pollution control agency that was established as a provision of and to implement the Ohio River Valley Water Sanitation Compact, signed in 1948 by the governors of Illinois, Indiana, Kentucky, New York, Ohio, Pennsylvania, Virginia, and West Virginia.
3.10. “Person” means an individual, partnership, association, syndicate, company, firm, trust, corporation, government corporation, institution, department, division, bureau, agency, federal agency, or any other entity recognized by law.
3.11. “Potential Source of Significant Contamination (PSSC)” means a facility or activity that stores, uses, or produces substances or compounds with potential for significant contaminating impact if released into the source water of a public water supply.
3.12. “Proficiency Testing Sample (PT)” means a sample provided to the laboratory for the purpose of demonstrating that the laboratory can successfully analyze the sample within specified acceptance limits specified in this rule. The qualitative composition, quantitative composition, or both, of the reference material is unknown to the laboratory at the time of analysis.
3.13. “Public groundwater supply source” means a primary source of water supply for a public water system which is directly drawn from a well, underground stream, underground reservoir, underground mine, or other primary source of water supplies which is found underneath the surface of the state.
3.14. “Public surface water supply source” means a primary source of water supply for a public water system which is directly drawn from rivers, streams, lakes, ponds, impoundments, or other primary sources of water supplies which are found on the surface of the state.
3.15. “Public surface water-influenced groundwater supply source” means a source of water supply for a public water system which is directly drawn from an underground well, underground river or stream, underground reservoir, or underground mine, and the quantity and quality of the water in that underground supply source is heavily influenced, directly or indirectly, by the quantity and quality of surface water in the immediate area.
3.16. “Public Water System” means a public water system is:
3.16.1. Any water supply or system which regularly supplies or offers to supply water for human consumption through pipes or other constructed conveyances, if serving at least an average of 25 individuals per day for at least 60 days per year, or which has at least 15 service connections, and shall include:
3.16.1.a. Any collection, treatment, storage, and distribution facilities under the control of the owner or operator of the system and used primarily in connection with the system; and
3.16.1.b. Any collection or pretreatment storage facilities not under such control which are used primarily in connection with the system.
3.16.2 A public water system does not include a system which meets all of the following conditions:
3.16.2.a. Consists only of distribution and storage facilities and does not have any collection and treatment facilities;
3.16.2.b. Obtains all of its water from, but is not owned or operated by, a public water system that otherwise meets the definition;
3.16.2.c. Does not sell water to any person; and
3.16.2.d. Is not a carrier conveying passengers in interstate commerce.
3.17. “Public Water Utility” means a public water system which is regulated by the West Virginia Public Service Commission pursuant to the provisions of W. Va. Code §24-1-1 et seq.
3.18. “Sanitary Survey” means an on-site review of the water source, facilities, equipment, operation, and maintenance of a public water system for the purpose of evaluating the adequacy of the source, facilities, equipment, operation, and maintenance for producing and distributing safe drinking water, as described in the federal regulations adopted in this rule.
3.19. “Secretary” means the Secretary of the Department of Health.
3.20. “Unaccounted for water” means the water introduced into the distribution system less all metered usage and all known non-metered usage which can be estimated with reasonable accuracy.
3.21. “Watershed” means an area of land from which surface water drains into a common outlet, such as a river, lake, or wetland.
3.22. “Wellhead Protection Area (WHPA)” means the surface and subsurface area surrounding a water well or wellfield, supplying a public water system, through which contaminants are reasonably likely to move toward and reach such water well or wellfield.
3.23. “Zone of Critical Concern (ZCC)” means the area for a public surface water supply that is comprised of a corridor along streams within a watershed that warrants more detailed scrutiny due to its proximity to the surface water intake and the intake’s susceptibility to potential contaminants within that corridor. The zone of critical concern is determined using a mathematical model that accounts for stream flows, gradient, and area topography. The length of the zone of critical concern is based on a five-hour time-of-travel of water in the streams to the water intake, plus an additional one-fourth mile below the water intake. The width of the zone of critical concern is 1,000 feet measured horizontally from each bank of the principal stream and 500 feet measured horizontally from each bank of the tributaries draining into the principal stream.
W. Va. Code R. § 64-3-4 Public Water System Construction, Alteration, or Renovation; Standards; Exceptions
4.1. A person shall not construct, alter, renovate, or award a contract for any construction, alteration, or renovation of a public water system without obtaining a permit from the commissioner.
4.2. Application for a permit to construct, alter, or renovate shall be made to the commissioner on forms prescribed by the commissioner at least 45 working days prior to the date on which approval by the commissioner is desired. The application shall be accompanied by an engineering report, maps, and detailed plans and specifications of the proposed construction, alteration, or renovation prepared by or under the direction of a registered professional engineer.
4.3. The commissioner may revoke a permit to construct, alter, or renovate for failure of the public water system to comply with this rule.
4.4. A permit to construct, alter, or renovate is valid for five years from the date of issuance.
4.5. The public water system shall be constructed, altered, or renovated in accordance with the plans and specifications approved by the commissioner in accordance with the Bureau for Public Health’s rule, “Public Water System Design Standards,” 64CSR77.
4.6. To the extent practical, all new or expanded facilities shall be located outside the hundred-year flood plain.
4.7. The commissioner may issue an order requiring a change in the source of the water supply for the system or in the manner of collection, treatment, storage, or distribution before delivery to the consumer as may be necessary to safeguard the public health.
4.8. A permit to construct, alter, or renovate is not required for any minor addition to, or alteration, or renovation of an existing public water system which will not significantly affect the quality or quantity of the water supply service rendered. The work shall be done in accordance with the provisions of the Bureau for Public Health’s rule, “Public Water System Design Standards,” 64CSR77.
4.9. A public water system shall submit a written description of the proposed additions, alterations, or renovations to the commissioner no less than 10 working days prior to implementing the additions, alterations, or renovations under this provision. The commissioner shall notify the system whether the proposed additions, alterations, or renovations qualify under this provision within five working days of receipt of the description.
4.10. All public water supply systems using a raw water source which is open to the atmosphere or subject to surface runoff shall, at a minimum, provide filtration treatment.
W. Va. Code R. § 64-3-5 Permit to Operate a Public Water System
5.1. A public water system shall be operated in accordance with this rule and the federal regulations adopted in this rule.
5.2. The commissioner will develop a program for the issuance of a permit to operate a public water system. The permit is renewable annually and may be revoked for failure to comply with the requirements of this rule or the federal standards adopted in this rule. The commissioner will administer the permit program uniformly and will not grant a permit until after he or she has completed a sanitary survey.
5.3. In the event of a proposed change in the ownership of a public water system, the new owner shall submit a written application to the commissioner at least 15 working days before the proposed change to transfer the permit to operate.
5.4. The current permit to operate shall be posted in a conspicuous place at the public water system’s treatment plant or main office.
W. Va. Code R. § 64-3-6 Inspections and Sanitary Surveys of Public Water Systems
6.1. The commissioner shall inspect public water systems and conduct sanitary surveys in accordance with the federal regulations adopted in this rule.
6.2. The commissioner has the right of access to all parts of a public water system. The public water system shall furnish the commissioner access to all information and records required to be kept by this rule and the federal regulations adopted in this rule.
W. Va. Code R. § 64-3-7 Public Water System Disinfection Requirements
7.1. Disinfection with chlorine, chlorine dioxide, chloramine, or ozone is required of all public water systems, provided the requirements of subsection 7.6. of this section are met.
7.2. The disinfectant shall be applied during treatment at a point before entering the distribution system which will provide effective log removal.
7.3. Ground water systems shall install chemical disinfection to provide at least a four-log virus inactivation or removal before or at the first customer, for any ground water source. Monitoring requirements are the same as the federal regulations adopted in this rule.
7.4. Surface water systems and groundwater systems under the direct influence of surface waters shall meet the disinfection requirements of the federal regulations adopted in this rule.
7.5. Chlorine residual testing equipment shall enable measurement of free and total chlorine residuals to the nearest 0.2 milligrams per liter.
7.6. For all public water systems, at least 0.2 milligrams per liter of total chlorine residual shall be maintained throughout the distribution system at all times and shall measure the total chlorine residual at least one time per day when serving water to the public and report the results in accordance with section 12 of this rule.
7.7. The commissioner may authorize exceptions, in writing, in the chlorine disinfection parameters specified in this section. The commissioner may impose additional monitoring requirements if an exception is authorized.
W. Va. Code R. § 64-3-8 Public Water System Fluoridation
8.1. A public water system which artificially adjusts fluoride levels shall strive to maintain those levels between 0.6 milligrams per liter and 0.8 milligrams per liter. The optimum target concentration for artificially adjusted fluoride is 0.7 milligrams per liter. If the drinking water of a public water system is found to be outside of the 0.6 to 0.8 milligrams per liter range, the public water system shall make any treatment or operational changes necessary to return the fluoride level to within the range within 24 hours of receiving the analytical result unless doing so is impracticable, in which case, the correction shall be made as soon as possible. A public water system shall identify in its annual report to the bureau the date and time of each instance where the fluoride levels were found to be outside the target range and how long it took to implement responsive adjustments.
8.2. The drinking water of artificially adjusted fluoridated or defluoridated public water systems shall be monitored once each day for fluoride concentration. Records of the monitoring shall be maintained in accordance with sections 9 and 10 of this rule.
8.3. At least once a month, any public water system that artificially adjusts the fluoride concentrations shall submit a sample of drinking water to the Commissioner or to a certified laboratory for fluoride analysis.
8.4. A public water system may adjust fluoride concentration levels or dosage rates in accordance with subsection 8.1. without the prior written approval of the commissioner.
8.5. A public water system may not modify the chemical composition or additives for water fluoridation, or discontinue fluoridation of drinking water, without the prior written approval of the commissioner.
8.5.1 Upon written request, the commissioner may authorize a modification to the chemical composition or additives for water fluoridation, or the discontinuance of fluoridation of drinking water.
8.5.2 In the event the commissioner approves a modification or discontinuance pursuant to this subsection, the commissioner may also impose additional monitoring requirements.
W. Va. Code R. § 64-3-9 Public Water System Control Tests and Record Maintenance
9.1. A public water system shall retain records of microbiological, turbidity, radiological, and chemical analyses, or a summary of the records, at a convenient location on or near the premises of the public water system, in accordance with the federal regulations adopted in this rule. The commissioner shall certify a laboratory or laboratories to conduct all tests and analyses required by this rule or the federal regulations adopted in this rule, with the exception of on-site water system operational tests. The public water system shall retain monthly operational reports, containing the information required to be submitted under subsection 12.4. of this rule, for five years.
W. Va. Code R. § 64-3-10 Adoption of Federal Regulations
10.1. The following federal regulations are hereby adopted by reference:
10.1.1. National Primary Drinking Water Regulations, 40 CFR Part 141, with the exception of the monitoring reduction provisions of Subpart Y, the specific portions of Subpart Y which are not being adopted by reference in this rule are as follows:
10.1.1.a. In 40 CFR § 141.854 (c) (2), the last three sentences, beginning with “The State may not allow systems to begin less frequent monitoring”…through the end of that subsection;
10.1.1.b. In 40 CFR § 141.854, sections (d), (e) and (h) in their entirety;
10.1.1.c. In 40 CFR § 141.854 (i) (2) the portion of the sentence that reads “unless it meets the criteria in paragraphs (i) (2) (i) through (iii) of the section to be eligible for monitoring less frequently than monthly”;
10.1.1.d. In 40 CFR § 141.854 (i) (2) (i) thru (iii) in their entirety; and
10.1.1.e. In 40 CFR § 141.855 (c) (2), (d), (e) and (f) in their entirety.
10.1.2. National Primary Drinking Water Regulations Implementation, 40 CFR Part 142, Subparts A and F, and Sections 40 CFR 142.20 (b), 142.21; 142.62, 142.63, 142.64 and 142.65; and
10.1.3. National Secondary Drinking Water Regulations, 40 CFR Part 143.
10.2. The commissioner will use the provisions of 40 CFR § 142.20 (b) and the requirements and procedures of Subpart F of 40 CFR Part 142, as adopted in this rule as applicable in granting exemptions. Nothing in this section shall authorize the granting of a variance by the Commissioner. For the purpose of granting exemptions, the following changes are made to Subpart F in 40 CFR Part 142:
10.2.1. The term “Commissioner” shall be substituted for the term “Administrator.”
10.2.2. The term “West Virginia” shall be substituted for the phrase “State that does not have primary enforcement responsibility.”
10.2.3. To meet the requirements of 40 CFR § 142.54 (b) (2), the commissioner need only provide notice to other appropriate state or local agencies at the commissioner’s discretion.
10.3. In the event of a conflict between a federal standard adopted in this rule and a state standard adopted in this rule, the more stringent standard applies.
10.4. The National Primary Drinking Water Regulations can be viewed online at http://water.epa.gov/lawsregs/rulesregs/sdwa/index.cfm. Copies of these regulations are available in hard copy from:
U.S. Environmental Protection Agency Region III 1650 Arch Street Philadelphia, PA 19103
W. Va. Code R. § 64-3-11 Bottled Water Treatment Plants and Distributors
11.1. No person shall operate a bottled water treatment plant in this state without first receiving from the commissioner a permit to bottle and distribute water.
11.2. No person shall distribute bottled water in this state without first receiving from the commissioner a permit to distribute bottled water.
11.3. Application for a permit to bottle and distribute water shall be made to the commissioner on forms prescribed by the commissioner. A completed application and a set of plans and specifications for the treatment plant shall be submitted to the commissioner for approval at least 45 working days prior to the date on which a permit from the commissioner is desired.
11.4. The source of the water to be bottled and the bottled water shall comply with Beverages, 21 CFR § 165 final regulations promulgated and published as final rules prior to the adoption of this rule, with the exception of sections 165.3 (b), 165.110 (a) (2) (ii).
11.4.1. The name of the water from a subsurface saturated zone that is under a pressure equal to or greater than atmospheric pressure is “ground water.” Ground water found to be under the direct influence of surface water as defined in 40 CFR § 141.2, as adopted by this rule, shall be treated by a method approved by the commissioner.
11.4.2. The bottler shall conduct microbiological monitoring not less than weekly on the finished product.
11.5. A bottled water treatment plant shall be operated in accordance with the provisions of the federal standards, Current Good Manufacturing Practice in Manufacturing, Packaging or Holding Human Food, 21 CFR Part 110, and Processing and Bottling of Bottled Drinking Water, 21 CFR Part 129.
11.6. The commissioner shall inspect each in-state bottled water treatment plant every 12 months or as he or she otherwise determines.
11.7. An out-of-state bottled water treatment plant desiring to distribute bottled water in West Virginia shall apply for a permit to bottle and distribute bottled water on forms approved by the commissioner. The out-of-state treatment plant shall comply with the requirements of this rule and the federal regulations adopted in this rule for in-state bottled water treatment plants. Subsequent to the initial evaluation, monitoring of the treatment plant by the regulatory agency of the state in which the treatment plant is located is considered acceptable for the purposes of this rule. The out-of-state treatment plant shall notify the commissioner of any corrective action it is required to take by its state regulatory authority and shall notify the commissioner of any change in ownership or in the event that it closes.
11.8. A person wishing to distribute bottled water in the state who does not operate a bottled water treatment plant shall apply for a permit to distribute bottled water on a form approved by the commissioner. The applicant shall identify the location of the plants from which the bottled water is obtained and any distributor other than the bottled water plant from which the bottled water is obtained and shall provide other information required by the commissioner. The commissioner shall grant a permit to distribute bottled water if the bottled water complies with the requirements of this rule.
11.9. The commissioner may revoke a permit for failure to comply with provisions of this rule.
W. Va. Code R. § 64-3-12 Public Water System Reporting Requirements
12.1. Unless otherwise specified in this rule or the federal regulations adopted in this rule, a public water system shall report to the commissioner the results of any test, measurement or analysis required to be made by this rule or the federal regulations adopted in this rule within 40 days of the system's receipt of the test, measurement, or analysis.
12.2. A public water system shall submit a summary of the public water system operation, test data, and other information as may be required by the commissioner to the commissioner at least once each month. The Commissioner may require more frequent reports in cases where there are public health concerns.
12.3. All reports and summaries required by this rule or federal regulations adopted in this rule shall be submitted in a manner or form approved by the commissioner.
12.4. A public water system shall distribute a public notice for any failure to comply with this rule or the federal regulations adopted in this rule. The content, distribution, recordkeeping, and reporting of the public notification shall be performed in a time and manner as specified in the federal rules adopted, by reference, in this rule with the exception of Tier 1 public notices. For Tier 1 public notices, the time required for initial public notices and consultation with the state shall be as soon as possible, but no more than 12 hours.
12.5. A public water system shall report to the commissioner any proposed long-term or permanent changes to their water treatment process, such as a change in fluoridation or changes in the chemicals used in the treatment process, in writing at least 60 days prior to the planned date of implementation, to allow for an evaluation of the change in water quality to the consumers.
W. Va. Code R. § 64-3-13 Certification of Laboratories to Conduct Drinking Water Tests
13.1. All laboratories providing drinking water testing results for purposes of this rule or the federal regulations adopted by this rule shall be certified by the commissioner or by the federal Environmental Protection Agency.
13.2. A certified laboratory shall:
13.2.1. Comply with the requirements and criteria contained in the federal Environmental Protection Agency's Manual for the Certification of Laboratories Analyzing Drinking Water, Fifth Edition, EPA 815-R-05-004, January 2005, Supplement I to the Fifth Edition of the Manual to the Certification of Laboratories Analyzing Drinking Water, EPA 815-F-08-006, June 2008, Supplement II to the Fifth Edition of the Manual to the Certification of Laboratories Analyzing Drinking Water, EPA 815-F-12-006, November 2012. In addition, before an analyst is permitted to do any regulatory compliance samples for chemistry, the Demonstration of Capability (DOC) required by each method must be completed. If there are no DOC requirements in the method, the following are guidelines to be used: At a minimum, the DOC shall include four replicates of a quality control or reference sample which must be processed through all steps of the analytical procedure and evaluated against laboratory derived acceptance limits. In addition, precision and accuracy must be established if more than one sample preparation technique is used;
13.2.2. Comply with the requirements of this rule and hold a certificate of recognition from the National Environmental Laboratory Accreditation Program (NELAP) for the analysis of drinking water; or
13.2.3. Any other accreditation determined to be equivalent by the commissioner.
13.3. An in-state laboratory shall submit an application form when seeking initial approval at least 60 days prior to the date certification is desired.
13.4. A laboratory located outside the boundaries of this state shall be certified by the commissioner if:
13.4.1. It has been certified by the federal Environmental Protection Agency; or
13.4.2. It has been certified by a program for the certification of laboratories equivalent to the program of this state as determined by the commissioner. If the program of the state in which the laboratory is located is not judged equivalent, the laboratory may request an on-site evaluation and full certification review by the commissioner. The commissioner may charge a fee for all expenses incurred for an on-site survey of an out-of-state laboratory.
13.5. An out-of-state laboratory shall submit an application form when seeking initial approval and shall include with its application evidence of compliance with subdivision 13.4.1. or 13.4.2. of this section. The out-of-state laboratory shall notify the commissioner immediately of any change in its certification status under subdivision 13.4.1. or 13.4.2. of this section.
13.6. The commissioner will conduct on-site inspections of in-state laboratories to determine compliance with this rule and the federal standards adopted in this rule initially prior to certification, and at least every three years thereafter. The bureau has the right of entry upon proper identification at any time considered necessary during operating hours in order to conduct the inspections.
13.7. The commissioner will issue certificates of approval upon initial approval and will renew the certificates on an annual basis thereafter pursuant to the conditions listed in this rule. Certificates issued will contain the name and location of the laboratory, a laboratory code number, the signatures of the state’s Office of Laboratory Services’ director and certification officers, and the date of expiration of the certificate.
13.7.1. Certified laboratories shall participate in a proficiency testing water study within the first three months of the calendar year. The study shall have a closing date no later than the last working day of March. If the commissioner does not receive proficiency testing water study results by the end of May of each calendar year, the commissioner will downgrade the laboratory to “provisionally certified” for each certified parameter not analyzed.
13.7.2. For a drinking water laboratory to maintain certification, the commissioner must receive an acceptable proficiency testing water study result for each certifiable parameter and by each approved method for which the laboratory holds, or is seeking, certification between January 1 and September 30 of each year. The proficiency testing provider shall forward the water study results directly to the commissioner; photocopies from the laboratory will not be accepted.
13.8. Certified laboratories shall notify the commissioner when there is a change in ownership, laboratory director, technical personnel, or location of the laboratory.
13.9. Certified laboratories shall submit to the commissioner all required or requested data, information, and reports in a manner or form approved or provided by the Commissioner.
13.10. Certified laboratories shall accept chemistry compliance monitoring samples only in containers that have been demonstrated and documented to be free of regulated or interfering contaminants. This demonstration shall be accomplished through testing using an approved drinking water method. The contaminants of interest must be shown to be below detectable levels on a representative container from any given lot after exposure to reagent water and any required preservatives.
13.11. Certified laboratories shall reject any public water system compliance monitoring sample that has exceeded its holding time for the indicated testing parameters, has not been received at the required temperature or pH, or does not contain the required preservatives, or is not in an approved container. Upon a rejection, the certified laboratory shall then notify the submitting public water system and the sample originator in a timely manner to allow for resampling and resubmission to prevent noncompliance with federal regulations and state rules and endangerment of public health.
13.12. The commissioner shall administer and use the criteria and procedures of the section titled “Criteria and Procedures for Downgrading/Revoking Certification Status” of the Manual for the Certification of Laboratories Analyzing Drinking Water referenced in subsection 13.2 of this section, when a laboratory’s noncompliance with the Manual, the provisions of this rule, or both, is detected.
13.13. For each parameter and method the laboratory holds certification and receives an unacceptable evaluation from the proficiency testing provider, shall submit a pre-placement proficiency testing study to the commissioner within 90 days of being notified of the unacceptable result. Failure to comply shall result in the parameter or method, or both, being downgraded.
13.14. For each parameter and method the certified laboratory has two consecutive unacceptable evaluations from the proficiency testing provider shall have the aforementioned parameter or method, or both, downgraded to “provisionally certified.”
13.15. A laboratory requesting reinstatement due to unacceptable proficiency testing water study performance must provide two consecutive proficiency testing water studies which have been evaluated to be acceptable by the proficiency testing provider.
W. Va. Code R. § 64-3-14 Source Water Protection Program
14.1. This rule establishes a statewide program for development and implementation of source water protection and planning. This program is intended to protect water supply sources from contamination due to substances entering the groundwater or surface water bodies which are used as water supply sources by public water systems and public water utilities.
14.2. The requirements specified in this rule are minimum requirements and shall not prevent a public water utility or a public water system from taking additional steps to protect its wells, springs, wellfields, or surface water intakes.
14.3. Each existing public water utility which draws and treats water from a surface water supply source or a surface water influenced groundwater supply source shall submit to the commissioner an updated or completed source water protection plan for each of its public water system plants to protect its public water supplies from contamination. The schedule for submission of the source water protection plans is set forth in section 16 of this rule.
14.4. The West Virginia Source Water Protection Program consists of two types of delineations for the West Virginia waterways. These are a broad Watershed Delineation Area (WSDA) and a detailed Zone of Critical Concern (ZCC) delineation.
14.4.1. The WSDA includes the entire watershed area upstream from a public water utility intake structure, up to the boundary of the state borders, a topographic boundary and is the perimeter of the catchment area that provides water to the water supply intake. This delineation will use available hydrologic unit codes (HUC) based on the watershed network established by the United States Geological Survey (USGS). The WSDA is an area where a general inventory can be performed by the Public Water System. A more detailed inventory and management plan may be warranted based upon the type and number of existing potential sources of significant contamination (PSSC).
14.4.2. The ZCC is a corridor along the streams, lakes, and reservoirs within the WSDA that warrants a more detailed inventory and management of potential sources of significant contamination due to its proximity to the source water intake and to the susceptibility to potential contaminants.
14.4.2.a. ZCC delineations consist of the following:
14.4.2.a.1. Free flowing streams within the WSDA using the following configuration:
14.4.2.a.1.A. Width along the source stream is 1,000 feet from each bank of the principal stream and 500 feet from each bank of all tributaries draining into the principal stream.
14.4.2.a.1.A.1. For purposes of this rule, these terms have the following definitions: 14.4.2.a.1.A.1.(a). Bank means the sides of a river or stream between which the water normally flows; 14.4.2.a.1.A.1.(b). The principal stream is defined as the stream where the source water intake for the public water utility is located; and 14.4.2.a.1.A.1.(c). Tributaries are all other waterways flowing into the principal stream.
14.4.2.a.1.B. Length along the source stream is determined based on a five-hour time-of-travel using an estimated 90 percent high flow rate that is equaled or exceeded on 10 percent of the days during the period of record or up to the next upstream intake, where it is available. If high flow rate data is not available through a mathematical model to calculate flow time, then a five-mph flow rate is used.
14.4.2.a.2. Reservoirs or lakes within the WSDA using the following standards:
14.4.2.a.2.A. Width – 1000 feet from each bank of the reservoir and 500 feet from each bank of the tributaries draining into the reservoir or lake.
14.4.2.a.2.B. Length along the source stream feeding into the reservoir or lake. The free flow stream segment will be delineated following the free flow stream procedure. If a lake or reservoir is encountered within the five-hour time-of-travel, the following delineation will take place: If the length of the lake or reservoir is less than or equal to the five-hour calculated time-of-travel distance from the intake, then the entire water body will be included. If the length of the lake or reservoir is greater than the calculated five-hour time-of-travel distance from the intake, then the section of water body within the five-hour time-of-travel distance will be used to establish the ZCC.
14.4.2.a.3. Ohio River Delineation –The Ohio River will use a tiered delineation system consisting of two protection zones for each Ohio River surface intake consisting of the following: Zone 1 --Zone of Critical Concern --The area adjacent to the Ohio River from one-quarter mile downstream of the intake to a distance of 25 miles (equivalent to a five-hour time-of-travel) upstream or the next upstream intake. The lateral extent of this zone extends one-quarter mile on both sides of the river and major tributaries. Zone 2 --Source Water --The entire portion of the Ohio River Basin upstream of the surface intake. This is equivalent to the West Virginia WSDA for the West Virginia waterways.
14.4.3. Conjunctive delineations will consist of the following for public surface water influenced groundwater supply sources:
14.4.3.a. The commissioner will determine whether a conjunctive delineation is required on a case by case basis;
14.4.3.b. The criteria that the state will use will be based on identification between selected parameters in the wells and in surface water in the nearby streams. Using this information, the commissioner will develop a statewide guidance standard for the designation; and
14.4.3.c. If a public water supply has been determined to be under the influence of surface water and its WHPA intersects the surface water body, then this system will be required to do a modified (full or partial) surface delineation in addition to the ground water delineation.
14.5. Every effort shall be made by the water utility to inform and engage the public, local governments, local emergency planners, local health departments, and affected residents at all levels of the development of the protection plan.
14.6. The completed or updated plan for each affected plant, at a minimum, shall include the following:
14.6.1. A contingency plan that documents each public water utility’s planned response to contamination of its public surface water supply source or its public surface water influenced groundwater supply source;
14.6.2. An examination and analysis of the public water system’s ability to isolate or divert contaminated waters from its surface water intake or groundwater supply, and the amount of raw water storage capacity for the public water system’s plant;
14.6.3. An examination and analysis of the public water system’s existing ability to switch to an alternative water source or intake in the event of contamination of its primary water source;
14.6.4. An analysis and examination of the public water system’s existing ability to close its water intake in the event the system is advised that its primary water source has become contaminated due to a spill or release into a stream, and the duration of time it can keep that water intake closed without creating a public health emergency;
14.6.5. The following operational information for each plant receiving water supplies from a surface water source shall include:
14.6.5.a. The average number of hours the plant operates each day, and the maximum and minimum number of hours of operation in one day at that plant during the past year; and
14.6.5.b. The average quantities of water treated and produced by the plant per day, and the maximum and minimum quantities of water treated and produced at that plant in one day during the past year;
14.6.6. An analysis and examination of the public water system’s existing available storage capacity on its system, how its available storage capacity compares to the public water system’s normal daily usage;
14.6.7. The calculated level of unaccounted for water experienced by the public water system for each surface water intake. The public water utility shall use the same method used in the Public Service Commission’s rule, “Rules for the Government of Water Utilities,” 150CSR7.6.1., to determine and report on their unaccounted for water. If the calculated percentage of unaccounted for water is in excess of 15 percent, the public water system shall describe all of the measures it is actively taking to reduce the level of water loss experienced in its system;
14.6.8. A list of the potential sources of significant contamination contained within the ZCC as provided by the Department of Environmental Protection, the Bureau for Public Health, and the Division of Homeland Security and Emergency Management in accordance with the provisions of W. Va. Code §16-1-9c(b)(8).
14.6.8.a. Examples of land uses and activities which are considered to be potential sources of significant contamination may be further described in the guidance document to be published by the commissioner.
14.6.8.b. The exact location of the contaminants within the ZCC is not subject to public disclosure in response to a Freedom of Information Act request under W. Va. Code §29B-1-1 et seq.
14.6.8.c. The location, characteristics, and approximate quantities of potential sources of significant contamination within the ZCC shall be made known to one or more designees of the public water utility, and shall be maintained in a confidential manner by the public water utility.
14.6.8.d. In the event of a chemical spill, release, or related emergency, information pertaining to any spill or release of contaminant shall be immediately disseminated to any emergency responders responding to the site of a spill or release, and the general public shall be promptly notified in the event of a chemical spill, release, or related emergency that poses a potential threat to public health and safety.
14.6.8.e. Any public water utility may identify additional potential sources of significant contamination that are located outside of the ZCC if it deems those potential sources to be of concern to the integrity of the water supply.
14.6.9. If the public water utility’s water supply plant is served by a single-source intake to a surface water source of supply or a surface water influenced source of supply, the submitted plan shall also include an examination and analysis of the technical and economic feasibility of each of the following options to provide continued safe and reliable public water service in the event its primary source of supply is detrimentally affected by contamination, release, spill event or other reason:
14.6.9.a. Constructing or establishing a secondary or backup intake which would draw water supplies from a substantially different location or water source;
14.6.9.b. Constructing additional raw water storage capacity, treated water storage capacity, or both, to provide at least two days of system storage, based on the plant’s maximum level of production experienced within the past year;
14.6.9.c. Creating or constructing interconnections between the public water system with other plants on the public water utility system or another public water system, to allow the public water utility to receive its water from a different source of supply during a period its primary water supply becomes unavailable or unreliable due to contamination, release, spill event, or other circumstance;
14.6.9.d. Any other alternative which is available to the public water utility to secure safe and reliable alternative supplies during a period its primary source of supply is unavailable or negatively impacted for an extended period; and
14.6.9.e. If one or more alternatives set forth in paragraphs 14.6.9.a. through 14.6.9.d. of this subdivision is determined to be technologically or economically feasible, the public water utility shall submit an analysis of the comparative costs, risks, and benefits of implementing each of the described alternatives.
14.6.10. A management plan that identifies specific activities that will be pursued by the public water utility, in cooperation and in concert with the Bureau for Public Health, local health departments, local emergency responders, local emergency planning committee, and other state, county, or local agencies and organizations to protect its source water supply from contamination, including, but not limited to, notification to and coordination with state and local government agencies whenever the use of its water supply is inadvisable or impaired, to conduct periodic surveys of the system, the adoption of best management practices, the purchase of property or development rights, conducting public education, or the adoption of other management techniques recommended by the commissioner or included in the source water protection plan;
14.6.11. A communications plan that documents the manner in which the public water utility, working in concert with state and local emergency response agencies, shall notify the state and local health agencies and the public of the initial spill or contamination event and provide updated information related to any contamination or impairment of the source water supply or the system’s drinking water supply, with an initial notification to the public to occur in any event no later than 30 minutes after the public water system becomes aware that the spill, release, or potential contamination of the public water system poses a potential threat to public health and safety;
14.6.12. A complete and comprehensive list of the potential sources of significant contamination contained within the ZCC, based upon information which is directly provided or can otherwise be requested and obtained from the Department of Environmental Protection, the Bureau for Public Health, the Division of Homeland Security and Emergency Management, and other resources; and
14.6.13. An examination of the technical and economic feasibility of implementing an early warning monitoring system.
14.6.14. Plans must be signed by a West Virginia Registered Professional Engineer (PE).
14.6.14.a. In the alternative, if the public water utility does not have a PE to sign its plan, it is acceptable to have the SWPP signed by the chief executive officer of a privately-owned water utility; or
14.6.14.b. In the alternative, if the public water utility does not have a PE to sign its plan, it is acceptable to have the SWPP signed by the board chairman or other presiding officer of a publicly owned water utility.
14.7. Any public water utility’s public water system with a primary surface water source of supply or a surface water influenced groundwater source of supply that comes into existence on or after July 1, 2014, shall submit, prior to the commencement of its operations, a source water protection plan satisfying the requirements of subsection 14.6. of this section.
14.8. The commissioner will review a plan submitted pursuant to this section and provide a copy to the secretary of the Department of Environmental Protection.
14.8.1. Within 180 days of receiving a plan for approval, the commissioner may approve, reject, or modify the plan as may be necessary and reasonable to satisfy the purposes of this rule.
14.8.2. The commissioner will consult with the local public health officer and conduct at least one public hearing when reviewing the initial source water protection plan that has been updated or completed. The public hearings required by this rule may be scheduled in conjunction with one or more public water utilities in the same watershed and will be held after notice to the public in all affected locations.
14.8.3. The failure by any public water utility to comply with its source water protection plan approved pursuant to this rule is a violation of this rule and may be subject to penalties set forth in section 17 of this rule.
14.9. The commissioner may request a public water utility to conduct one or more studies to determine the actual risk and consequences related to any potential source of significant contamination (PSSC) identified by the plan, or as otherwise made known to the commissioner.
14.10. Any public water utility required to file a complete or updated plan in accordance with the provisions of this rule shall submit an updated source water protection plan at least every three years or when there is a substantial change in the potential sources of significant contamination within the identified ZCC.
14.11. Any public water utility required to file a complete or updated plan in accordance with the provisions of this section shall review any source water protection plan it may currently have on file with the bureau and update it to ensure it conforms with the requirements of this rule.
14.12. The commissioner’s authority in reviewing and monitoring compliance with a source water protection plan may be transferred by the bureau to a nationally accredited local board of health.
W. Va. Code R. § 64-3-15 Wellhead and Source Water Protection Grant Program
15.1. The commissioner shall continue the Wellhead and Source Water Protection Grant Program.
15.1.1. The fund heretofore created to provide funds for the Wellhead and Source Water Protection Grant Program is continued in the state treasury and shall be known as the Wellhead and Source Water Protection Grant Fund.
15.1.2. The fund will be administered by the commissioner and shall consist of all moneys made available for the program from any source, including, but not limited to, all fees, civil penalties and assessed costs, all gifts, grants, bequests, or transfers from any source, any moneys that may be appropriated and designated for the program by the Legislature and all interest or other return earned from investment of the fund.
15.1.3. Expenditures from the fund shall be for the purposes set forth in this rule to provide water source protection pursuant to the program and are not authorized from collections but are to be made only in accordance with appropriation by the Legislature and in accordance with the provisions of W. Va. Code §12-3-1 et seq. and upon the fulfillment of the provisions set forth in W .Va. Code §11B-2-1 et seq.
15.1.4. Any balance, including accrued interest and other returns, remaining in the fund at the end of each fiscal year shall not revert to the General Revenue Fund but shall remain in the fund and be expended as provided by this section.
15.2. In prospectively awarding any grants under the Wellhead and Source Water Protection Grant Program, the commissioner shall prioritize those public water systems where there is the highest probability of contamination of the water source based on the source water assessment report or the source water protection plans which were previously performed. Priority shall also be extended to publicly owned public water systems over privately owned public water systems.
15.3. The commissioner, or his or her designee, will apply for and diligently pursue all available federal funds to help offset the cost of completing source water protection plans by the deadlines established in W. Va. Code §16-1-9c.
15.4. The commissioner may receive any gift, federal grant, other grant, donation, or bequest and receive income and other funds or appropriations to contribute to the Wellhead and Source Water Protection Grant Program.
W. Va. Code R. § 64-3-16 Source Water Protection Plan Submission Schedules and Watershed Descriptions
16.1. The commissioner may organize the public water utilities required to submit Source Water Protection Plans (SWPP) under this rule by watersheds. Grouping the public water utilities in this manner will enhance protection of the public water supply by looking at the potential sources of significant contamination (PSSC) across the entire watershed to protect all downstream uses of water from any contamination occurring upstream.
16.2. To better manage the state’s streams, the state is divided into 32 HUC-8 watersheds by the West Virginia Department of Environmental Protection. Those streams are further consolidated into one of five hydrologic regions (Regions 1 - 5). All source water streams that provide intakes for public water utilities are assigned to one of the five regions for purposes of collecting and reviewing the SWPP submitted by public water utilities in each watershed.
16.3. The watershed designations are as follows:
16.3.1. Region 1 Watershed – Contains the Upper Ohio North, Upper Ohio South, Middle Ohio North, Middle Ohio South, and Little Kanawha HUC-8 watersheds.
16.3.2. Region 2 Watershed – Contains the Dunkard, Monongahela, West Fork, Tygart Valley, Cheat, and Youghiogheny HUC-8 watersheds.
16.3.3. Region 3 Watershed – Contains the North Branch Potomac, South Branch Potomac, Cacapon, Shenandoah Hardy, Potomac Direct Drains, and Shenandoah Jefferson HUC-8 watersheds.
16.3.4. Region 4 Watershed – Contains the Lower Kanawha, Upper Kanawha, Elk, Gauley, Greenbrier, Coal, Lower New, Upper New, and James HUC-8 watersheds.
16.3.5. Region 5 Watershed – Contains the Lower Ohio, Lower Guyandotte, Upper Guyandotte, Big Sandy, Twelvepole, and Tug Fork HUC-8 watersheds.
16.4. All public water utilities in the Region 1 Watershed are required to submit their SWPP update to the bureau no later than March 1, 2020, and every three years thereafter.
16.5. All public water utilities in the Region 2 Watershed are required to submit their SWPP update to the bureau no later than October 1, 2020, and every three years thereafter.
16.6. All public water utilities in the Region 3 Watershed are required to submit their SWPP update to the bureau no later than May 1, 2021, and every three years thereafter.
16.7. All public water utilities in the Region 4 Watershed are required to submit their SWPP update to the bureau no later than December 1, 2021, and every three years thereafter.
16.8. All public water utilities in the Region 5 Watershed, and any public water utilities from the other watersheds that have not previously submitted their SWPP, are required to submit their new or updated SWPP to the bureau no later than July 1, 2022, and every three years thereafter.
16.9. The grouping of public water utilities required to submit SWPP to the bureau into regional watersheds is proposed for the efficiency and convenience of the water utilities and the residents served by them. Nothing in this rule prohibits a public water system from submitting its SWPP to the bureau at any time prior to the due date noted above.
W. Va. Code R. § 64-3-17 Penalties
17.1. Any person who violates any provision of this rule or orders issued under this rule is subject to injunction, criminal prosecution, and criminal, civil and administrative fines, all as provided in W. Va. Code §16-1-9, §16-1-9a, §16-1-9c, §16-1-17, and §16-1-18.
17.2. Any individual or entity who violates the provisions of this rule or any orders issued pursuant to this rule is liable for a civil penalty of not less than $1,000.00 nor more than $5,000.00. Each day’s violation constitutes a separate offense.
17.3. Any individual or entity who commits a willful violation of any provision of this rule or orders issued pursuant to this rule shall be subject to a civil penalty of not more than $10,000.00 and each day’s violation shall be grounds for a separate penalty.
17.4. Civil penalties under this section are payable to the commissioner. All moneys collected under this rule shall be deposited into a restricted account known as the Safe Drinking Water Fund. All moneys deposited in the fund shall be used by the commissioner to provide technical assistance to public water systems.
17.5. The commissioner may also seek injunctive relief in the circuit court of the county in which all or part of the public water system is located.
W. Va. Code R. § 64-3-18 Administrative Due Process
18.1 Those persons adversely affected by the enforcement of this rule desiring a contested case hearing to determine any rights, duties, interests or privileges shall do so in accordance with the Bureau for Public Health’s Rule, “Rules of Procedure for Contested Case Hearings and Declaratory Rulings,” 64CSR1.
Series 04 Public Water Systems Operators
W. Va. Code R. § 64-4-1 General
1.1. Scope. -- This rule governs the examination and certification of operators of Public Water Systems (PWS), establishes a system for classification of Public Water Systems, and specifies certain responsibilities of Public Water Systems.
1.2. Authority. -- W. Va. Code §16-1-4(a)(4) and §16-1-9a(b)(4)(B).
1.3. Filing Date. -- March 27, 2024.
1.4. Effective Date. -- March 27, 2024.
1.5. Sunset Provision. -- This rule shall terminate and have no further force or effect on August 1, 2029.
W. Va. Code R. § 64-4-2 Application and Enforcement
2.1. Application. -- This rule applies to owners, certified operators, and operators-in-training (OITs) of a PWS and to applicants for certification.
2.2. Enforcement. -- This rule is enforced by the Commissioner of the Bureau for Public Health.
W. Va. Code R. § 64-4-3 Definitions
3.1. 1D Operator. -- An individual holding a valid 1D West Virginia PWS operator certification issued by the Commissioner.
3.2. Adequate. -- A sufficient amount the Commissioner determines, considering hours of operation of the treatment plant, treatment complexity, distribution extent, source of water, and other factors such as personnel leave.
3.3. Certified Operator. -- An individual holding a valid West Virginia PWS operator certification issued by the Commissioner.
3.4. Chief Operator. -- The certified operator, designated by the owner, who is responsible for managing the daily operational activities of an entire PWS or a water treatment facility, or a distribution system in a manner that ensures meeting state and federal safe drinking water regulations.
3.5. Class I Operator. -- An individual holding a valid Class I West Virginia PWS operator certification issued by the Commissioner.
3.6. Class II Operator. -- An individual holding a valid Class II West Virginia PWS operator certification issued by the Commissioner.
3.7. Class III Operator. -- An individual holding a valid Class III West Virginia PWS operator certification issued by the Commissioner.
3.8. Class IV Operator. -- An individual holding a valid Class IV West Virginia PWS operator certification issued by the Commissioner.
3.9. Class R Operator. -- An individual holding a valid Class R West Virginia PWS operator certification issued by the Commissioner.
3.10. Commissioner. -- Commissioner of the West Virginia Bureau for Public Health or his or her designee.
3.11. Community Water System. -- A PWS that serves at least 15 service connections used by year-round residents or regularly serves at least 25 year-round residents.
3.12. Consecutive System. -- A PWS that receives some or all of its finished water from one or more other PWSs.
3.13. Continuing Education Hour (CEH). -- One hour of participation in an organized continuing education experience under responsible sponsorship approved by the Commissioner for renewal of a PWS operator certification.
3.14. Continuing Education Unit (CEU). -- 10 CEHs.
3.15. Distribution System. -- Facilities downstream of the water treatment plant used to convey water for human consumption, which may include storage tanks, disinfection mechanisms, pumps, valves, hydrants, meters, and other appurtenances.
3.16. Drinking Water. -- Water produced by a PWS that conforms to the requirements of Bureau for Public Health legislative rule, Public Water Systems, 64CSR3.
3.17. Experience. -- Hands-on work performing certified operator duties at a Public Water System.
3.18. Groundwater (GW). -- A source of water under the ground, typically from a well, that is not open to the atmosphere (surface water) or under the direct influence of surface water (groundwater under the direct influence).
3.19. Groundwater Under the Direct Influence (GUDI). -- A source of groundwater determined to be under the influence of a surface water source.
3.20. Non-Transient Non-Community Water System. -- A PWS that is not a community water system and that regularly serves at least 25 of the same persons over six months per year.
3.21. Operating Shift. -- That period of time during which operator decisions that affect public health are necessary for proper operation of the PWS.
3.22. Operate. -- To perform the practical work and apply the technical knowledge and operational skills in the treatment, testing, and distribution of drinking water.
3.23. Operator-in-Training (OIT). -- An individual who holds a valid operator-in-training certificate issued by the Commissioner, and who is training under the responsibility of the Chief Operator at a PWS while completing the educational and experience requirements to become a Water Distribution System (WDS) or Class I operator.
3.24. Owner. -- The person legally responsible for the operation of a PWS.
3.25. Person. -- An individual, partnership, association, syndicate, company, firm, trust, corporation, government, institution, department, division, bureau, agency, federal agency, or any other entity recognized by law.
3.26. Population. -- Population served by a PWS as determined by the Commissioner.
3.27. Present. -- To be readily available to perform tasks at the water treatment plant and intake by physically being located on-site unless otherwise determined by the Commissioner in advance in writing.
3.28. Primary Contaminant. -- Any contaminant, other than disinfection for microbiological, that has a maximum contaminant level (MCL) or treatment technique in accordance with Bureau for Public Health legislative rule, Public Water Systems, 64CSR3.
3.29. Public Water System (PWS). -- Any water supply or system that regularly supplies or offers to supply water for human consumption through pipes or other constructed conveyances, if serving at least an average of 25 individuals per day for at least 60 days per year, or which has at least 15 service connections, and shall include: (1) Any collection, treatment, storage, and distribution facilities under the control of the owner or operator of the system which are used primarily in connection with the system; and (2) Any collection or pretreatment storage facilities not under the control of the owner or operator of the PWS which are used primarily in connection with the system. A PWS does not include a system which meets all of the following conditions: (1) Consists only of distribution and storage facilities and does not have any collection and treatment facilities; (2) Obtains all of its water from, but is not owned or operated by, a PWS that otherwise meets the definition; (3) Does not sell water to any person; and (4) Is not a carrier conveying passengers in interstate commerce.
3.30. Surface Water (SW) and Ground Water Under the Direct Influence of Surface Water. -- A source that has been determined to be open to the atmosphere or subject to surface water runoff.
3.31. Transient Non-Community Water System. -- A PWS that does not regularly serve at least 25 of the same persons over six months per year.
3.32. Water Distribution System (WDS) Operator. -- An individual holding a valid WDS West Virginia PWS operator certification issued by the Commissioner. A water operator certified at the WDS level shall only operate within the water distribution system or conduct distribution system related functions at a Class I or higher PWS.
3.33. Water Treatment Plant. -- A facility to process and treat water for distribution to consumers in accordance with Bureau for Public Health legislative rule, Public Water Systems, 64CSR3.
W. Va. Code R. § 64-4-4 Classification of Public Water Systems
4.1. A PWS is classified on the basis of source water, population, and the complexity of the water treatment processes.
4.1.1. 1D: A transient non-community PWS that has groundwater only as a source and does not use gaseous chlorine or chlorine dioxide as a means of disinfection and does not treat for the removal of nitrate or nitrite, or both. A groundwater source that uses gaseous chlorine, chlorine dioxide as a means of disinfection, or has treatment for removal of nitrate or nitrite, or both is at least a Class I PWS.
4.1.2. Class R: A non-transient PWS that retreats at the point of entry, with anything other than chlorine, another PWS’s finished water for facility use and consumption only. A Class R that provides water to another PWS is at least a Class I PWS.
4.1.3. Water Distribution System (WDS): A PWS that obtains all of its water from another PWS and is not owned or operated by the supplying PWS. A WDS does not have any other source of water other than water from the supplying PWS. A WDS may apply chlorine for supplemental disinfection but otherwise does not treat its water. A WDS that retreats with anything other than chlorine is at least a Class I PWS.
4.1.4. Class I: A community or non-transient non-community PWS with a GW source that serves a population of less than 10,000, including consecutive connection population, and does not treat for an identified primary contaminant. A transient non-community PWS that has a GW source that uses gaseous chlorine, chlorine dioxide as a means of disinfection, or has treatment for removal of nitrate or nitrite, or both.
4.1.5. Class II: A community or non-transient non-community PWS with:
4.1.5.a. A GW source that serves a population of less than 10,000, including consecutive connections, and either treats for an identified primary contaminant, or has a treatment technique as identified in 40CFR141.73;
4.1.5.b. A GW source that serves a population of at least 10,000, including consecutive connections that does not treat for an identified primary contaminant; or,
4.1.5.c. A GUDI or SW source that serves a population of less than 10,000, including consecutive connections.
4.1.6. Class III: A community or non-transient non-community PWS with:
4.1.6.a. A GW source that serves a population of greater than 10,000, including consecutive connections, and either treats for an identified primary contaminant, or has a treatment technique as identified in 40CFR141.73; or,
4.1.6.b. A GUDI or SW source that serves a population of at least 10,000, but less than 20,000, including consecutive connections.
4.1.7. Class IV: A community or non-transient non-community PWS with a GUDI or SW source that serves a population of at least 20,000, including consecutive connection population, and has treatment.
W. Va. Code R. § 64-4-5 Required Personnel and Conditions of Employment
5.1. An individual who operates a 1D, Class R, WDS, Class I, Class II, Class III, or Class IV PWS in West Virginia must be certified by the Commissioner.
5.2. A certified water operator shall:
5.2.1. Be responsible for their certification in accordance with all aspects of this rule;
5.2.2. Carry his or her current certification card issued by the Commissioner upon them at all times the operator is operating the PWS;
5.2.3. Not work in a PWS under the certification of another person; only the person whose name appears on the operator certification is certified by that document. Certifications are not transferable;
5.2.4. Notify the Commissioner at least 30 calendar days in advance of the voluntary termination of his or her employment at a PWS;
5.2.5. Comply with the provisions of Bureau for Public Health legislative rule, Public Water Systems, 64CSR3; and,
5.2.6. Demonstrate data integrity by providing complete, accurate, and true information for the period in which they were responsible for data collection including, but not limited to, records, reports, and lab results.
5.3. 1D, Class R, and the distribution portion only of a PWS under the direct jurisdiction of the treatment plant are not required to designate a Chief Operator.
5.3.1. The owner of a 1D system shall ensure it is operated by a 1D, Class I, or higher water operator.
5.3.2. The owner of a Class R system shall ensure it is operated by a Class R, Class I, or higher water operator.
5.3.3. The owner of a WDS system shall ensure it is operated by a WDS, Class I, or higher water operator.
5.4. The owner of PWS shall:
5.4.1. Employ a Chief Operator with a certification equal to or higher than the system classification, except for 1D and Class R PWSs. A PWS may have more than one Chief Operator if jurisdiction is bifurcated between the distribution system and treatment plant or otherwise approved in writing by the Commissioner based upon a written request;
5.4.1.a. In the case of a distribution system not under the direct jurisdiction of the treatment plant Chief Operator, employ an additional Chief Operator with WDS, Class I, or higher certification and an adequate number of certified operators to operate the distribution system.
5.4.1.b. Place direct supervision of their PWS, including each treatment facility and distribution system, under the responsible charge of the Chief Operator holding an adequate certification.
5.4.2. Employ an adequate number of certified operators to operate the system;
5.4.3. Not employ more OITs than the number of employed certified operators, unless written permission is granted by the Commissioner;
5.4.4. Notify the Commissioner within 24 hours, in a manner and form approved by the Commissioner, of any certified operator or OIT employment status changes;
5.4.5. Submit a personnel status report as of July 1 by July 15 every year. The report shall be in a manner and form approved by the Commissioner and required information includes, at a minimum: a list of all certified operators employed, the Chief Operators, and the system owner; and,
5.4.6. Post a copy of the current certification of all certified operators employed at the PWS in a conspicuous location in the water treatment plant, or, if there is no water treatment plant, the PWS office.
5.5. The Chief Operator of a PWS shall:
5.5.1. Be responsible for the operation of the PWS;
5.5.2. Be employed on a full-time basis by the PWS owner except in WDS and Class I systems;
5.5.3. Attend a course approved by the Commissioner for training as a Chief Operator. Attendance of the designated course is also applicable for CEH credit for the renewal cycle. A person newly designated by the owner as the Chief Operator after the effective date of this rule shall attend the course within one year. Class R and 1D systems are exempt from the requirements of this subdivision;
5.5.4. Apply to the Commissioner for OIT certification, on behalf of OIT applicants, within 30 days of their hire at the PWS. An OIT’s experience gained for certification starts only upon the issued date of the OIT certificate;
5.5.5. Be responsible for training and job duty assignments of OITs and other certified operators and properly document each OIT’s or other certified operator’s experience towards certification upgrade;
5.5.6. Renew the OIT certification every two years or until all requirements for WDS or Class I certification are met. Submit the renewal application at least 30 calendar days prior to the expiration date, in a manner and form approved by the Commissioner. The OIT shall attempt to pass the WDS or Class I examination at least once during each two-year renewal; and,
5.5.7. Be automatically designated as the Chief Operator if he or she is the only certified operator who meets the requirements of subsection 5.4. of this section for the PWS.
5.6. Adequate Operator Coverage:
5.6.1. Class R PWSs shall have a Class R, Class I, or higher operator present at all times water quality decisions are made to ensure proper operation in accordance with all applicable state and federal laws.
5.6.2. 1D and WDS PWSs shall have an operator with certification equal to or greater than the system classification present at all times water quality decisions are made and present at least once every day to ensure proper operation in accordance with all applicable state and federal laws.
5.6.3. Class I PWSs shall have a Class I or higher operator present at all times water quality decisions are made. A properly certified operator shall be present at least once every day when the plant is operational to ensure proper operation in accordance with all applicable state and federal laws.
5.6.4. Class II PWSs shall have an operator with certification equal to or greater than the system classification present in the primary treatment facility at all times when the plant is operational unless the Commissioner grants a written limited waiver to this requirement in response to a written request by the owner of the PWS. If granted, a limited waiver shall permit an operator who has, at a minimum, passed the next highest level certification examination to perform the tasks of an operator certified one grade higher. All limited waivers granted will be individual and system specific (not transferable) and may be rescinded immediately if compliance concerns arise.
5.6.4.a. Class I operators at Class II PWSs who apply for a limited waiver in writing from the Commissioner to operate without on-site supervision of a Class II operator shall, at a minimum, pass the Class II exam before being considered for a limited waiver.
5.6.5. Class III and IV PWSs shall have an operator with certification no lower than one class below the system classification present in the primary treatment facility at all times when the plant is operational.
5.6.6. Class II, III, and IV PWSs shall have at least one certified operator (except 1D, Class R, or WDS level) in addition to the Chief Operator, unless the Commissioner grants a written limited waiver to this requirement in response to a written request by the owner of the PWS. If granted, a limited waiver shall permit an operator who has, at a minimum, passed the next highest level certification examination to perform the tasks of an operator certified one grade higher. All limited waivers granted will be individual and system specific (not transferable) and may be rescinded immediately if compliance concerns arise.
W. Va. Code R. § 64-4-6 Qualifications for Certification
6.1. An individual desiring certification shall submit an application for certification to the Commissioner. The application shall be on a form approved by the Commissioner.
6.2. Certification of a PWS operator is based on education, a passing grade on the applicable certification examination, and in some cases experience as an OIT or higher certification. The education and experience requirements for certification are set forth in Table 64-4A of this rule.
6.3. Class R and 1D operator certifications are not sequential towards OIT, WDS, and Class I through IV. A Class R or 1D operator shall begin with application for an OIT if he or she wishes to operate a WDS, Class I, or higher classification system.
6.4. WDS operator certification is not sequential towards Class I certification. A WDS operator shall begin with application for an OIT if he or she wishes to operate a Class I or higher classification system.
6.5. Class I through IV operator certification applicants shall obtain certification for each Class level in sequence.
6.6. An individual seeking certification as a WDS or Class I operator shall begin with an application for OIT certification.
6.7. Applicants for certification shall be 18 years of age or older. This may be waived to a minimum age of 16 upon written request to the Commissioner and in accordance with subsection 7.2. of this rule.
W. Va. Code R. § 64-4-7 Education Requirements
7.1. The education requirements for each certification are listed in Table 64-4A of this rule.
7.2. OIT education requirements may be waived by the Commissioner, in writing, to completion of 10th grade. The student must provide verification each semester he or she is attending school and maintaining a 2.0 average or better on a 4.0 scale towards graduation requirements. The certificate may be revoked for failure to meet these requirements.
7.3. Education requirements may be waived by the Commissioner, in writing, for applicants who are actively working towards a GED. The student must provide verification for each semester that he or she is enrolled in an adult education program and completing graduation requirements. The certificate may be revoked for failure to meet these requirements.
7.4. The Commissioner-approved Class R certification course and passing the Class R exam education requirement can be substituted with a Commissioner-approved manufacturer certification if requested in writing and adequate information is provided.
7.5. The number of CEUs credited for courses and operating experience are in Table 64-4B.
7.6. The Commissioner evaluates all education courses to be considered for CEUs. 100 percent credit will be awarded for those determined to be directly related to water treatment and distribution; examples are mathematics, science, and business courses. If the Commissioner determines the course is not directly related, 50 percent credit will be awarded.
7.7. Class III and IV applicants may substitute up to half of the required CEU education as specified in Tables 64-4A and B of this rule with additional experience upon written request to the Commissioner.
7.7.1. An applicant cannot use experience used as a substitute for the educational requirement to also satisfy the experience requirement.
7.7.2. An applicant may use the Class R, 1D, WDS, Class I, and Class II certification courses towards the educational requirements for a Class III or higher-class level certificate.
W. Va. Code R. § 64-4-8 Experience Requirements
8.1. The experience requirements for each classification are listed in Table 64-4A of this rule.
8.2. Only experience obtained as a valid certified water operator may count towards the experience required by this rule.
8.3. Experience as an operator, unless substituted pursuant to subdivision 8.6.1. of this rule, should be predominantly “hands-on” or necessary skills, knowledge, ability, and judgment acquired from daily operating experience rather than from text book study or supervisory observation. It means the individual has actually operated a water treatment plant or worked in the distribution system and has performed tasks including, but not limited to, routine tests, sample collection, completion of operational reports, and calculations of chemical dosages and subsequent adjustment of chemical feeders or backwashed filters.
8.4. Experience obtained exclusively in distribution, maintenance, and other non-operational or treatment duties may not count for more than 600 hours of the total experience required for Class I through IV certification.
8.5. Class II applicants at Class I systems may obtain 2,000 hours experience at a Class I PWS and successfully complete a Commissioner-approved course instead of obtaining 2,000 hours at a Class II or higher PWS.
8.6. An applicant may substitute the experience requirements as set forth in this rule with education and training as specified in subdivisions 8.6.1. and 8.6.2. of this rule:
8.6.1. Class II, III, and IV applicants may substitute up to half of the required experience with additional education upon written request to the Commissioner.
8.6.2. An applicant may not use education used as a substitute for experience requirements to satisfy education requirements.
W. Va. Code R. § 64-4-9 Examination Requirements
9.1. Examination requirements for each level of certification are listed in Table 64-4A of this rule.
9.2. Examinations shall not be administered until the Commissioner-approved certification course requirements are first met, unless the Commissioner grants a written exception based on a written request.
9.3. An applicant for operator certification shall submit an application for examination in a form and manner approved by the Commissioner with proof of education and, if required, separate proof of work experience.
9.4. The Commissioner shall schedule examinations for water operator certification applicants meeting the requirements of this rule and notify the applicants before the examination date.
9.5. An individual shall make a score of 70 percent or better on the examination in order to pass the examination.
9.6. The results of certification examinations are valid for five years. If the applicant has not met the requirements for education, experience, or both within those five years, the applicant shall reapply for examination and regain a passing score.
9.7. An applicant who fails an examination shall wait a minimum of 60 days from the date he or she took the examination before reapplying for the examination.
W. Va. Code R. § 64-4-10 Renewal Requirements
10.1. All certified operators must submit the appropriate renewal application at least 30 calendar days prior to the expiration date, but no earlier than 60 calendar days prior to the expiration date of their certificate.
10.2. The Commissioner shall approve continuing education hour (CEH) courses based on their relevance to PWSs.
10.3. The number of CEHs required by each classification each renewal period is as follows:
10.3.1. Class R: A minimum of one CEHs required for renewal;
10.3.2. OIT: A minimum of six CEHs required for renewal;
10.3.3. WDS: A minimum of six CEHs required for renewal;
10.3.4. Class I: A minimum of 12 CEHs required for renewal;
10.3.5. Class II, III, and IV: A minimum of 24 CEHs required for renewal; and,
10.3.6. 1D: No CEHs required for renewal.
10.4. Operators may not use the same CEH course in consecutive renewal periods.
10.5. Operators may not carry over additional CEHs completed during the two-year period to satisfy the CEH requirements for the next certification renewal period.
10.6. The Commissioner may extend the time requirements for obtaining CEHs upon written request by the applicant.
10.7. The Commissioner may specify certain courses an operator shall attend in order to qualify for renewal.
W. Va. Code R. § 64-4-11 Expiration
11.1. A PWS operator certification expires two years from the date of issuance. An individual with expired certification shall not operate a PWS in West Virginia.
11.2. An applicant seeking reinstatement of his or her previous certification shall pass the examination at the certification level previously held if his or her certification has been expired for more than one year.
11.3. If an individual holds a Class R, 1D, or WDS certification in addition to a Class I or higher certification, the Class R, 1D, or WDS will not expire if the Class I or higher certification is properly maintained.
W. Va. Code R. § 64-4-12 Certification from Another Jurisdiction
12.1. The Commissioner shall grant certification to a PWS operator certified by another jurisdiction if the applicant:
12.1.1. Is actively seeking, has been offered, or has accepted employment in West Virginia which requires a certified operator;
12.1.2. Submits a completed application in a manner and form approved by the Commissioner;
12.1.3. Meets the educational and work experience requirements of this rule; and,
12.1.4. Demonstrates he or she has successfully passed an examination in another jurisdiction substantially equivalent to the certification level sought, as determined by the Commissioner.
12.1.4.a. To be considered substantially equivalent, the other jurisdiction’s examination must contain questions with the majority of questions covering the following topics, including related mathematics: Treatment processes, chemistry, and laboratory methods; Compliance, which must equate to the standards set forth in the Safe Drinking Water Act, 42 U.S.C. §300f et seq., and the National Primary Drinking Water Regulations, 40 C.F.R. Part 141; Plant operation; and Distribution. If the Commissioner determines that the other jurisdiction has substantially different regulations that solely prevent the examination from being substantially equivalent, then the Commissioner may require an applicant to take a West Virginia-specific operator course within 24 months of granting a Reciprocal Operator License but without a requirement that the applicant take an additional examination.
12.1.4.b. If the Commissioner determines the other jurisdiction’s examination is substantially equivalent, a Reciprocal Operator License will be issued for the equivalent West Virginia certification level. The Commissioner may condition and limit renewal of the License on a requirement for additional education classes as allowed under subsection (a).
12.1.4.c. If the Commissioner determines the other jurisdiction’s examination is not substantially equivalent, the applicant must pass the West Virginia certification examination equivalent to the certification level of the other jurisdiction.
W. Va. Code R. § 64-4-13 Suspension and Revocation
13.1. The Commissioner may suspend or revoke the certification of an operator if the individual:
13.1.1. Uses fraud or deceit in obtaining certification;
13.1.2. Fails to comply with this rule. Failure to notify the Commissioner of voluntary termination of employment in accordance with subdivision 5.2.4. of this rule, even though the failure shall not subject the certified operator to the penalties of section 14 of this rule.
13.1.3. Performs the duties of a water operator in a grossly negligent or incompetent manner;
13.1.4. Knowingly or negligently submits misleading, inaccurate, or false reports to the Commissioner; or,
13.1.5. Violates, or causes to be violated, any portion of Bureau for Public Health legislative rules, Public Water Systems, 64CSR3, or Cross-Connection Control and Backflow Prevention, 64CSR15.
13.2. The Commissioner shall notify the certified operator and the employer via certified mail of a proposed suspension or revocation. The notification shall set forth the action proposed, the effective date, the reason for the suspension or revocation, and the length of time of the proposed action.
13.3. The suspension of an operator’s certification is effective for an initial period of not more than one year, during which time the certification is not valid, and the individual may not operate a PWS. The individual shall obtain the CEHs required for that certification level, as if the suspension had not occurred.
13.4. The revocation of an operator’s certification is for a period of not less than one year during which time the certification is not valid, and the individual may not operate a PWS. After the period of ineligibility caused by the revocation has expired, the formerly certified operator shall, at a minimum, pass the examination at the certification level previously held to regain certification.
W. Va. Code R. § 64-4-14 Penalties
14.1. A person subject to the provisions of this rule shall comply fully with them and shall not direct or assist another person to violate this rule.
14.2. A person who violates any provision of this rule or any rules or orders of the Bureau for Public Health is guilty of a misdemeanor and shall, upon conviction, be punished by a fine of not more than $500, as provided under W. Va. Code §16-1-18. Each day there is a failure to comply with a provision of this rule may be a separate offense.
W. Va. Code R. § 64-4-15 Administrative Due Process
15.1. Those persons adversely affected by the enforcement of this rule may request a contested case hearing in accordance with Bureau for Public Health procedural rule, Rules of Procedure for Contested Case Hearings and Declaratory Rulings, 64CSR1.
Table 64-4A OPERATOR EDUCATION AND EXPERIENCE REQUIREMENTS FOR CERTIFICATION CLASS EDUCATION REQUIRED EXPERIENCE REQUIRED Class R HS diploma or GED, Commissioner-approved Class R certification course & passing the Class R exam.* No experience required. 1D Commissioner-approved 1D certification course & passing the 1D exam.
No experience required.
OIT HS diploma or GED.* No experience required.
WDS HS diploma or GED, Commissioner-approved WDS certification course & passing the WDS exam. 1,000 hours (six months full-time) at a WDS or higher PWS.
Class I HS diploma or GED, Commissioner-approved Class I certification course & passing the Class I exam. 2,000 hours (one year full-time) at a PWS.** Class II HS diploma or GED, Commissioner approved Class II certification course & passing the Class II exam.*** 4,000 hours (two years full-time) at a PWS with at least 2,000 of those hours at a Class II or higher PWS.** Class III HS diploma or GED and successfully completing 90 CEUs** and passing the Class III exam.*** 8,000 hours (four years full-time) at a Class I or higher PWS with at least 2,000 of those hours at a Class II or higher PWS.** Class IV HS diploma or GED and successfully completing 180 CEUs** and passing the Class IV exam.*** 10,000 hours (five years full-time) at a Class I or higher PWS with at least 2,000 of those hours at a Class III or higher PWS.** * and ** Refer to sections 7 and 8 of this rule. *** Refer to section 5 of this rule which allows public water systems to apply for a limited waiver of education and experience requirements which, if granted, shall permit a certified operator to perform the tasks of an operator one grade higher.
Table 64-4B CEUs FOR COURSES AND OPERATING EXPERIENCE 10 CEHs 1 CEU 1 College Semester Credit Hour
1.5 CEU 1 College Quarter Credit Hour 1 CEU 2,000 hours of experience 45 CEU See subsection 7.6.
64CSR4
64CSR4
Series 05 Wastewater Systems and Operators
W. Va. Code R. § 64-5-1 General
1.1. Scope. -- This rule governs the examination and certification of wastewater operators, establishes a system for the classification of wastewater systems, and specifies certain responsibilities of wastewater systems.
1.2. Authority. -- W. Va. Code §16-1-4(a)(4) and §16-1-9a(b)(4)(B).
1.3. Filing Date. -- March 27, 2024
1.4. Effective Date. -- March 27, 2024.
1.5. Sunset Provision. -- This rule shall terminate and have no further force or effect on August 1, 2029.
W. Va. Code R. § 64-5-2 Application and Enforcement
2.1. Application. -- This rule applies to owners and certified operators of wastewater systems and to applicants for certification. This rule does not apply to industrial wastewater systems which are regulated by the West Virginia Department of Environmental Protection (WV DEP) or to the operators of the industrial wastewater systems. This rule does not apply to septic tanks serving individual homes unless the systems have a centralized component.
2.2. Enforcement. -- This rule is enforced by the Commissioner of the Bureau for Public Health.
W. Va. Code R. § 64-5-3 Definitions
3.1. Adequate. -- A sufficient amount of time, as determined by the Commissioner, considering treatment complexity, collection system, and other factors such as personnel leave.
3.2. Advanced Operator. -- An individual holding a valid advanced West Virginia wastewater operator designation issued by the Commissioner.
3.3. Certified Operator. -- An individual holding a valid West Virginia wastewater operator certification issued by the Commissioner.
3.4. Chief Operator. -- The certified operator whom the owner designates to be responsible for managing the daily operational activities of a wastewater system or a collection system in a manner that ensures meeting state and federal Clean Water Act rules and regulations.
3.5. Class I Operator. -- An individual holding a valid Class I West Virginia wastewater operator certification issued by the Commissioner.
3.6. Class II Operator. -- An individual holding a valid Class II West Virginia wastewater operator certification issued by the Commissioner.
3.7. Class III Operator. -- An individual holding a valid Class III West Virginia wastewater operator certification issued by the Commissioner.
3.8. Class IV Operator. -- An individual holding a valid Class IV West Virginia wastewater operator certification issued by the Commissioner.
3.9. Class C Operator. -- An individual holding a valid Class C West Virginia wastewater operator certification issued by the Commissioner. This classification was previously referred to as 1C.
3.10. Class H Operator. -- An individual holding a valid Class H West Virginia wastewater operator certification issued by the Commissioner.
3.11. Class HR Operator. -- An individual holding a valid Class H West Virginia wastewater operator certification issued by the Commissioner with restricted (R) operations. This certification only applies to an individual homeowner who was grandfathered in accordance with this rule or has taken the Class H course and passed the Class H exam who is limited to operating only his or her individually owned Class H system. Class HR certification does not have a certification fee and does not require a high school diploma or GED.
3.12. Class S Operator. -- An individual holding a valid Class S West Virginia wastewater operator certification issued by the Commissioner. This classification was previously referred to as 1S.
3.13. Collection System. -- Facilities upstream of the wastewater treatment plant used to convey wastewater to the treatment plant.
3.14. Commissioner. -- Commissioner of the West Virginia Bureau for Public Health or his or her designee.
3.15. Continuing Education Hour (CEH). -- One hour of participation in an organized continuing education experience under responsible sponsorship approved by the Commissioner for renewal of wastewater operator certification.
3.16. Continuing Education Unit (CEU). -- 10 CEHs.
3.17. Experience. -- Hands-on work performing certified operator duties at a wastewater system.
3.18. GPD. -- Gallons per day.
3.19. Home Aeration Unit (HAU). -- Sewage treatment and disposal system of domestic sewage only permitted capability of 600 gpd or less, serving individual residences and/or certain commercial establishments. It is also known as aerobic treatment unit (ATU).
3.20. MGD. -- Million gallons per day.
3.21. National Pollutant Discharge Elimination System (NPDES). -- The federal wastewater discharge permit issued by the WV DEP.
3.22. Operate. -- To perform the practical work and apply the technical knowledge and operational skills in the treatment and collection of wastewater.
3.23. Operator-in-Training (OIT). -- An individual holding a valid operator-in-training certificate, issued by the Commissioner, who is training under the responsibility of the Chief Operator at a wastewater system while completing the educational and experience requirements to become a Class I operator.
3.24. Owner. -- The person legally responsible for the operation of a wastewater system.
3.25. Person. -- An individual, partnership, association, syndicate, company, firm, trust, corporation, government, institution, department, division, bureau, federal agency, or any other entity recognized by law.
3.26. Secretary. -- Secretary of the WV DEP or his or her designee.
3.27. Wastewater. -- Water containing human, animal, or domestic waste, except this definition does not include industrial wastewater regulated by the WV DEP.
3.28. Wastewater System. -- A facility collecting, treating, and discharging wastewater, except this definition does not include industrial wastewater systems regulated by the WV DEP.
W. Va. Code R. § 64-5-4 Classification of Wastewater Systems
4.1. A wastewater system is classified on the basis of the permitted flow capacity and complexity of the wastewater treatment processes.
4.1.1. Class H – A lagoon, aerated lagoon, stabilization pond, recirculating media filter, package treatment plant, or a small wastewater system with flows less than 600 gpd. This rule does not apply to septic tanks serving individual homes.
4.1.2. Class S – A lagoon, aerated lagoon, stabilization pond, recirculating media filter, package treatment plant, or a small wastewater system with flows greater than 600 gpd, but less than or equal to 0.05 MGD. It can also be multiple individual septic tanks within a managed residential district. Individual homeowner septic tanks are only included in this class if they are maintained under the jurisdiction of a responsible management entity. This classification was previously referred to as 1S.
4.1.3. Class C – A facility upstream of the wastewater treatment plant used to collect and convey wastewater. It may include pumps, valves, manholes, tanks, and other appurtenances. These facilities are also known as a collection system. This class does not include Class S facilities.
4.1.4. Class I – A lagoon, aerated lagoon, stabilization pond, or wastewater system with flows greater than 0.05 MGD, but less than or equal to 1.0 MGD. This class includes extended aeration package treatment plants with flows greater than 0.05 MGD, but less than or equal to 0.1 MGD.
4.1.5. Class II – A lagoon, aerated lagoon, stabilization pond, or wastewater system with flows greater than 1.0 MGD, but less than or equal to 1.75 MGD. This class includes extended aeration treatment plants with flows greater than 0.1 MGD, but less than or equal to 1.75 MGD.
4.1.6. Class III – A facility with flows greater than 1.75 MGD but less than 6.0 MGD.
4.1.7. Class IV – A facility with flows equal to or greater than 6.0 MGD.
4.1.8. Advanced – A system designation held in addition to Class S and Class I through Class IV classifications, where advanced treatment methods are used such as: membrane filtration or separate nitrification; denitrification; phosphorus removal; ammonia stripping; breakpoint chlorination; carbon adsorption; chemical coagulation; flocculation; precipitation; demineralization ion exchange, reverse osmosis, or electrodialysis; or other processes considered advanced by the Commissioner.
W. Va. Code R. § 64-5-5 Required Personnel and Conditions of Employment
5.1. Any individual who operates a Class S, Class C, Class I, Class II, Class III, or Class IV wastewater system in West Virginia shall be certified by the Commissioner. Any individual who operates a Class H wastewater system in West Virginia shall be certified by the Commissioner or Secretary.
5.2. A certified wastewater operator shall:
5.2.1. Be responsible for his or her certification in accordance with all aspects of this rule.
5.2.2. Carry his or her current certification card issued by the Commissioner upon them at all times the operator is operating the wastewater system.
5.2.3. Not work in a wastewater system using the certification of another person; only the person whose name appears on the operator certification is certified by that document. Certifications are not transferable.
5.2.4. Notify the Commissioner at least 30 calendar days in advance of the voluntary termination of his or her employment at a wastewater system.
5.2.5. Comply with the provisions of Bureau for Public Health legislative rule, Sewer Systems, Sewage Treatment Systems, and Sewage Tank Cleaners, 64CSR9.
5.2.6. Demonstrate data integrity by providing complete, accurate, and true information for the period in which he or she was responsible for data collection including, but not limited to, records, reports, and lab results.
5.3. A Class H and Class S system and the collection system portion only of a wastewater system under the direct jurisdiction of the treatment plant are not required to designate a Chief Operator.
5.3.1. The owner of a Class H wastewater system shall ensure it is operated by a Class H, Class I, or higher wastewater operator.
5.3.2. The owner of a Class S wastewater system shall ensure it is operated by a Class S wastewater operator.
5.3.3. The owner of a Class C wastewater system shall ensure it is operated by a Class C, Class I, or higher wastewater operator.
5.4. The owner of a wastewater system shall:
5.4.1. Employ a Chief Operator with certification equal to or higher than the system classification, except for Class H, Class S, and Class C systems. A wastewater system shall have more than one Chief Operator if jurisdiction is bifurcated between the collection system and treatment plant or otherwise approved in writing by the Commissioner based upon written request;
5.4.1.a. In the case of collection systems not under the direct jurisdiction of the treatment plant Chief Operator, employ an additional Chief Operator with a Class C, Class I, or higher certification and an adequate number of certified operators to operate the collection system. The owner shall:
5.4.1.a.1. Employ a Chief Operator to be on-site at all new wastewater systems, except for Class H, Class S, and Class C, when construction is 25 percent complete; and
5.4.1.a.2. Place direct supervision of the wastewater system, including each treatment facility and collection system, under the responsible charge of the Chief Operator holding an adequate certification;
5.4.2. Employ an adequate number of certified operators to operate the system;
5.4.3. Not employ more OITs than the number of employed certified operators of higher classification, unless written permission is granted by the Commissioner;
5.4.4. Notify the Commissioner and Secretary within 24 hours, in a manner approved by the Commissioner, of any employment status changes of the system’s certified operators, including their reassignment, except for Class H systems;
5.4.5. Submit a personnel status report as of July 1 by July 15 every year, except for Class H systems. The report shall be in a manner approved by the Commissioner and required information includes, at a minimum: a list of all certified operators employed, the Chief Operator, and the system owner;
5.4.6. Post a copy of the current certification of all certified operators employed at the wastewater system in a conspicuous location in the wastewater system treatment plant or the wastewater system office, except for Class H systems; and,
5.4.7. Employ an advanced certified operator to be on-site at all new advanced systems when construction is 50 percent complete.
5.5. The Chief Operator of a wastewater system shall:
5.5.1. Be responsible for the operation of the wastewater system;
5.5.2. Be employed on a full-time basis by the wastewater system owner except in Class C and Class I systems;
5.5.3. Attend a course approved by the Commissioner for training as a Chief Operator. A person newly designated by the owner as the Chief Operator after the effective date of this rule shall attend within one year;
5.5.4. Apply to the Commissioner for OIT certification, on behalf of an OIT applicant, within 30 calendar days of his or her hire at the wastewater system. An applicant’s experience gained for certification starts only upon the issued date of the OIT certificate;
5.5.5. Be responsible for the training and job duty assignments of OITs and other certified operators and proper documentation of this experience towards a certification upgrade;
5.5.6. Renew the certification of each OIT employee every two years or until all requirements for Class I certification are met. Applicants must submit their renewal application at least 30 calendar days prior to their certificate’s expiration date, in a manner approved by the Commissioner. The OIT shall attempt to pass the Class I examination at least once during each two-year renewal; and,
5.5.7. Be automatically designated as the Chief Operator if he or she is the only certified operator who meets the requirements of subsection 5.4 of this section for the system.
5.6. Adequate Operator Coverage:
5.6.1. Class H systems shall be operated by a Class H, Class I, or higher wastewater operator who shall be on call 24 hours a day/seven days a week. A Class H, Class I, or higher operator shall conduct an adequate number of on-site visits to ensure proper operation in accordance with the NPDES permit.
5.6.2. Class S systems shall be operated by a Class S operator who shall be on call 24 hours a day/seven days a week. A Class S operator shall conduct an adequate number of on-site visits to ensure proper operation in accordance with the NPDES permit. If a Class S system is designated as an advanced system, the individual providing adequate coverage in accordance with this section shall have the advanced designation.
5.6.3. Class C systems shall be operated by a Class C, Class I, or higher operator who shall be on call 24 hours a day/seven days a week. A Class C, Class I, or higher operator shall conduct an adequate number of on-site visits to ensure proper operation in accordance with the NPDES permit.
5.6.4. Class I systems shall be operated by a Class I or higher operator who shall be on call 24 hours a day/seven days a week. A Class I or higher operator shall conduct an adequate number of on-site visits to ensure proper operation in accordance with the NPDES permit. If a Class I system is designated as an advanced system, the individual providing adequate coverage in accordance with this section shall have the advanced designation.
5.6.5. Class II, Class III, and IV systems shall be operated on-site at least 40 hours per week by an operator with certification equal to or greater than the system classification, unless the Commissioner grants a written limited waiver to this requirement in response to a written request by the system owner. If granted, a limited waiver shall permit an operator who has, at a minimum, passed the next highest level certification examination to perform the tasks of an operator certified one grade higher. An operator certified at a level equal to or greater than the system classification shall be on call 24 hours a day/seven days a week. Class II, Class III, and IV systems shall have at least one certified operator (except Class H, Class S, or Class C level) in addition to the Chief Operator. If a Class II or higher system is designated as an advanced system, the individual providing adequate coverage in accordance with this section shall have the advanced designation. Adequate operator coverage shall be maintained at all times to ensure proper operation in accordance with the NPDES permit.
W. Va. Code R. § 64-5-6 Qualifications for Certification
6.1. An individual desiring certification shall submit an application for certification to the Commissioner. The application shall be on a form provided by the Commissioner.
6.2. Certification of a wastewater operator is based on his or her application, education, a passing score on the applicable certification exam, and in some cases experience as an OIT or higher certified operator.
6.3. Class H, Class S, and Class C certifications are not sequential towards OIT and Class I through IV certifications. Class H, Class S, or Class C applicants seeking to obtain a Class I or higher classification shall begin with an application for an OIT.
6.4. A person working in a Class I, II, III, or IV system shall begin certification as an OIT.
6.5. Applicants shall obtain Class I through IV certifications in sequential roman numerical order.
6.6. Applicants for certification shall be 18 years of age or older. The age requirement may be waived to a minimum age of 16 upon a written request to the Commissioner and in accordance with subsection 7.3. of this rule.
6.7. Applicants who qualify for Class H, Class S, or Class C certification in addition to a current Class I or higher certification shall hold the certifications concurrently, but only maintain the renewal requirements for the highest certification held.
6.8. The Commissioner shall charge an initial fee for certification provided as listed in Table 64-5A of this rule.
W. Va. Code R. § 64-5-7 Education Requirements
7.1. The education requirements for each certification are listed in Table 64-5B of this rule.
7.2. The Commissioner may waive Class H education requirements, if requested in writing, and the individual agrees to restricted operations.
7.3. The Commissioner may waive OIT education requirements, if requested in writing, to completion of the 10th grade. The student must provide verification each semester that he or she is currently attending school and maintaining a minimum of a 2.0 average on a 4.0 scale towards graduation requirements. Certification may be revoked for failure to meet the above requirements.
7.4. The Commissioner may waive the education requirements, if requested in writing, for applicants who are actively working towards a GED. The student must provide verification each semester that he or she is currently enrolled in an adult education program and completing graduation requirements. Certification may be revoked for failure to meet the above requirements.
7.5. The number of CEUs credited for courses and operating experience are in Table 64-5C of this rule.
7.6. The Commissioner evaluates all education courses for CEU. Credit of 100 percent shall be awarded for those determined to be directly related to wastewater treatment and collection, such as mathematics, science, computer, engineering, and business courses. If the Commissioner determines the course is not directly related, 50 percent credit shall be awarded.
7.7. Class III and IV applicants may request in writing to the Commissioner to be allowed to substitute up to half of the required CEU education as specified in Table 64-5B of this rule with additional experience.
7.7.1. An applicant may not use experience used as a substitute for educational requirements and to also satisfy experience requirements.
7.7.2. An applicant may use the Class H, Class S, Class C, Class I, Class II, and advanced courses towards the educational requirements for a Class III or higher class-level certificate.
W. Va. Code R. § 64-5-8 Experience Requirements
8.1. The experience requirements for each classification are listed in Table 64-5B of this rule.
8.2. Only experience obtained as a valid certified wastewater operator may count towards the experience required for the purposes of this rule.
8.3. Experience as an operator, unless substituted pursuant to subdivision 8.6.1. of this rule, should be predominantly “hands-on” or the necessary skills, knowledge, ability, and judgment acquired from daily operating experience rather than from text book study or supervisory observation. It means the individual has actually operated a wastewater treatment plant or worked in the collection system and has performed tasks including, but not limited to, routine tests, sample collection, completion of operational reports, calculation of chemical dosages, and the subsequent adjustment of chemical feeders or backwashed filters.
8.4. Experience obtained exclusively in collection, maintenance, and other non-operational or treatment duties shall not count as more than 600 hours of the total experience required for Class I through IV certification.
8.5. Experience obtained exclusively in laboratory duties shall not count as more than 1,000 hours of the total experience required for Class I through IV certification.
8.6. An applicant may substitute the experience requirements as set forth in this rule with education and training as specified in this subsection:
8.6.1. Class II, III, and IV applicants may substitute up to half of the required experience with additional education upon written request to the Commissioner.
8.6.2. An applicant may not use education used as a substitute for experience requirements to satisfy education requirements.
W. Va. Code R. § 64-5-9 Examination Requirements
9.1. Examination requirements for each certification are listed in Table 64-5B of this rule.
9.2. An applicant shall first meet the Commissioner-approved certification course requirements before examinations will be administered, unless the Commissioner grants a written exception based on a written request.
9.3. An applicant for operator certification shall submit an application for examination in a manner approved by the Commissioner with proof of education and, if required, separate proof of work experience.
9.4. The Commissioner shall schedule examinations for wastewater operator certification for applicants meeting the requirements for examination and notify applicants before the examination date.
9.5. An individual shall make a score of 70 percent or better on the examination in order to be considered a passing grade.
9.6. The results of certification examinations are valid for five years. If the applicant has not met the requirements for education, experience, or both within those five years, the applicant shall reapply for examination.
9.7. An applicant who has failed an examination shall wait a minimum of 60 calendar days from the date he or she took the examination before reapplying to retake the examination.
W. Va. Code R. § 64-5-10 Renewal Requirements
10.1. The applicant shall submit a renewal application at least 30 calendar days before, but no earlier than 60 calendar days prior to, the expiration date of their certification in a manner approved by the Commissioner.
10.2. The Commissioner shall approve continuing education hour (CEH) courses based on their relevance to wastewater systems.
10.3. The number of CEHs required by each classification each renewal period are:
10.3.1. Class S: three CEHs;
10.3.2. Class C: six CEHs;
10.3.3. OIT: six CEHs;
10.3.4. Class I and II: 12 CEHs;
10.3.5. Class III and IV: 24 CEHs; and
10.3.6. Class H and advanced designation: No CEHs.
10.4. An applicant may not repeat CEHs in consecutive renewal periods.
10.5. Operators shall not carry over additional CEHs completed during the two-year period to satisfy the CEH requirements for the next certification renewal period.
10.6. The Commissioner may grant extensions upon written request by the applicant.
10.7. The Commissioner may specify certain courses an operator shall attend in order to qualify for renewal.
10.8. The Commissioner shall charge a renewal fee for certification provided as listed in Table 64-5A of this rule.
W. Va. Code R. § 64-5-11 Expiration
11.1. All wastewater operator certifications expire two years from the date of issuance. An individual with an expired certification shall not operate a wastewater system in West Virginia.
11.2. An applicant seeking reinstatement of his or her previous certification shall pass the examination at the certification level previously held if his or her certification has been expired for more than one year.
11.3. Advanced designation of an individual does not expire.
11.4. If an individual holds a Class H, Class S, or Class C in addition to a Class I or higher certification, the Class H, Class S, or Class C shall not expire so long as the Class I or higher certification is properly maintained.
W. Va. Code R. § 64-5-12 Certification from Another Jurisdiction
12.1. The Commissioner shall grant certification to a wastewater operator certified by another jurisdiction if the applicant:
12.1.1. Is actively seeking, has been offered, or has accepted employment which requires a certified operator in West Virginia;
12.1.2. Submits a completed application in a manner approved by the Commissioner;
12.1.3. Meets the educational and work experience requirements of this rule; and,
12.1.4. Demonstrates he or she has successfully passed an examination in another jurisdiction substantially equivalent to the certification level sought, as determined by the Commissioner.
12.1.4.a. To be considered substantially equivalent, the other jurisdiction’s examination must contain questions covering the following topics, including related mathematics: System process monitoring; Evaluation and adjustment of wastewater treatment processes; Evaluation and maintenance of equipment; Equipment operation; Laboratory analysis; and Compliance, which must equate to the standards set forth in the Clean Water Act, 3 U.S.C. §1251 et seq. If the Commissioner determines that the other jurisdiction has substantially different regulations that solely prevent the examination from being substantially equivalent, then the Commissioner may require an applicant to take a West Virginia-specific operator course within 24 months of granting a Reciprocal Operator License but without a requirement that the applicant take an additional examination.
12.1.4.b. If the Commissioner determines the other jurisdiction’s examination is substantially equivalent, a Reciprocal Operator License will be issued for the equivalent West Virginia certification level. The Commissioner may condition and limit renewal of the License on a requirement for additional education classes as allowed under subsection (a).
12.1.4.c. If the Commissioner determines the other jurisdiction’s examination is not substantially equivalent, the applicant must pass the West Virginia certification examination equivalent to the certification level of the other jurisdiction.
W. Va. Code R. § 64-5-13 Suspension and Revocation
13.1. The Commissioner may suspend or revoke the certification of a wastewater operator if the individual:
13.1.1. Uses fraud or deceit in obtaining certification;
13.1.2. Fails to comply with this rule;
13.1.3. Performs the duties of a wastewater operator in a grossly negligent or incompetent manner;
13.1.4. Knowingly or negligently submits misleading, inaccurate, or false reports to the Commissioner; or
13.1.5. Violates or causes to be violated, any portion of the WV Department of Environmental Protection’s legislative rule, NPDES Program, 47CSR10, or the U.S. Clean Water Act.
13.2. The Commissioner shall notify the certified wastewater operator and the employer via certified mail of a proposed suspension or revocation. The notification shall set forth the action proposed, the effective date, the reason, and the length of time of the proposed action.
13.3. The suspension of a wastewater operator’s certification is effective for an initial period of not more than one year, during which time the certification is not valid and the individual cannot operate a wastewater system. The individual shall obtain the CEHs required for that certification level, as if the suspension had not occurred.
13.4. The revocation of a wastewater operator’s certification is for a period of not less than one year during which time the certification is not valid and the individual cannot operate a wastewater system. After the period of ineligibility caused by the revocation has expired, the formerly certified wastewater operator shall pass the examination at the certification level previously held at a minimum to regain certification.
W. Va. Code R. § 64-5-14 Penalties
14.1. A person subject to the provisions of this rule shall comply fully with them and shall not direct or assist another person to violate this rule.
14.2. A person who violates any provision of this rule or any rules or orders of the Bureau for Public Health is guilty of a misdemeanor and shall, upon conviction, be punished by a fine of not more than $500, as provided under W. Va. Code §16-1-18. Each day there is a failure to comply with a provision of this rule is a separate offense.
W. Va. Code R. § 64-5-15 Administrative Due Process
Those persons adversely affected by the enforcement of this rule may request a contested case hearing in accordance with the Bureau for Public Health procedural rule, Rules of Procedure for Contested Case Hearings and Declaratory Rulings, 64CSR1.
Table 64-5A FEES Type Amount Class HR Initial and Renewal No Fee Class H Initial and Renewal $100 Class S Initial and Renewal $100 Class C Initial and Renewal $100 OIT Initial and Renewal No Fee Class I Initial and Renewal $125 Class II Initial and Renewal $150 Class III Initial and Renewal $175 Class IV Initial and Renewal $200 Advanced Designation No Fee Renewal Late Fee $25 Note: Individuals who hold multiple wastewater operator certifications shall pay the initial fee for each and only the renewal fee associated with the highest-level certification held thereafter.
Table 64-5B OPERATOR EDUCATION AND EXPERIENCE REQUIREMENTS Class Education Experience Class H HS diploma or GED*, Commissioner-approved certification course & passing the Class H exam.
Class S HS diploma or GED, Commissioner-approved certification course & passing the Class S exam.
Class C HS diploma or GED, Commissioner-approved certification course & passing the Class C exam.
OIT HS diploma or GED.* Class I HS diploma or GED, Commissioner-approved certification course & passing the Class I exam. 2,000 hours (one year full-time) wastewater system experience as an OIT.** Class II HS diploma or GED, Commissioner-approved certification course & passing the Class II exam.*** 4,000 hours (two years full-time) wastewater system experience at a Class I or higher-class level wastewater system as a Class I operator.** Class III HS diploma or GED, 90 CEUs* & passing the Class III exam.*** 8,000 hours (four years full-time) wastewater system experience, 2,000 of which shall be at a Class II or higher-class level wastewater system as a Class II operator.** Class IV HS diploma or GED, 180 CEUs* & passing the Class IV exam.*** 10,000 hours (five years full-time) wastewater system experience, at least 4,000 of which shall be at a Class III or higher-class level wastewater system as a Class III operator.** Advanced Commissioner-approved training course. * and ** Refer to Sections 7, 8, and 9. *** Refer to section 5 of this rule which allows public water systems to apply for a limited waiver of education and experience requirements which, if granted, shall permit a certified operator to perform the tasks of an operator one grade higher.
Table 64-5C CEUs FOR COURSES AND OPERATING EXPERIENCE 10 CEHs 1 CEU 1 College Semester Credit Hour
1.5 CEUs 1 College Quarter Credit Hour 1 CEU 2,000 hours of experience 45 CEUs Note Section 7.6.
64CSR5
64CSR5
Series 07 Reportable Diseases, Events and Conditions
W. Va. Code R. § 64-7-1 General
1.1. Scope -- This legislative rule establishes procedures governing the reporting of certain diseases and conditions, unusual health events, and clusters or outbreaks of diseases to the Bureau for public health. It also establishes the responsibility of various individuals and facilities in controlling communicable diseases. The W. Va. Code is available in public libraries and on the Legislature’s web page, http:/ /www.legis.state.wv.us/.
1.2. Authority -- W. Va. Code §§16-3-1, 16-1-4; related 16-3C-1 et seq., 16-4-1 et seq., 16-22-3, 16-35-4 and 16-40-7.
1.3. Filing Date -- July 12, 2013.
1.4. Effective Date -- August 12, 2013.
1.5. Applicability -- This rule applies to physicians and other licensed health practitioners; local health officers; other public health providers; private or public laboratories; administrators of the West Virginia Health Information Network (WVHIN); all health care facilities; the Bureau; health care professional licensing boards and agencies; any individual administering immunizations; administrators of schools, camps, and vessels; administrators of health care facilities operated by the department; the State registrar of vital statistics; county humane officers, dog wardens, sheriffs, pathologists, coroners, veterinarians and other animal health care providers, and medical examiners; and any other person investigating or treating disease, health conditions, exposure or alleged exposure to infectious agents, or cause of death.
1.6. Enforcement -- This rule is enforced by the Commissioner of the West Virginia Bureau for Public Health or his or her designee.
W. Va. Code R. § 64-7-2 Definitions
2.1. Animal health care providers - Veterinarians or veterinary technicians or other individuals providing health care to animals.
2.2 Automatic reporting capability – The ability of an electronic laboratory reporting system to report laboratory findings through an electronic interface using HL7 messaging such that data is automatically transferred from a laboratory database to the West Virginia Health Information Network (WVHIN) or the West Virginia Electronic Disease Surveillance System (WVEDSS) without human intervention.
2.3. Biological toxin - Toxin produced by microorganisms, including botulinium toxin or toxins of Staphylococcus aureus or Clostridium perfringens; or toxic products or byproducts of higher plants or animals, such as ricin.
2.4. Bioterrorism Agent - Infectious agent or biological toxin deliberately introduced into the food, air, water or other part of the environment; or directly into an animal or human with the criminal intent of causing disease in animals or humans.
2.5. Bioterrorist event - The occurrence of a case of disease or a disease outbreak due to a bioterrorism agent; or attempted exposure of one or more individuals to a bioterrorism agent.
2.6. Bureau - The Bureau for public health of the West Virginia department of health and human resources.
2.7. Case - An occurrence of disease in a human or animal which meets a specific case definition listed in the West Virginia Reportable Diseases Protocol Manual or a case definition approved by the Commissioner. (Manual is available online at www.dide.wv.gov)
2.8. Center for Medicare and Medicaid Services (CMS) – The Federal agency responsible for providing health coverage for Medicare and Medicaid beneficiaries and promoting quality of care for these beneficiaries.
2.9. Cluster - An aggregation of cases of disease in time and place with or without exceeding the expected number of cases; frequently the expected number of cases is not known.
2.10. Commissioner - The Commissioner of the Bureau for public health of the West Virginia department of health and human resources or his or her designee.
2.11. Communicable Disease - A disease caused by an infectious agent or its toxic products, which is transmitted, directly or indirectly, to a susceptible host from an infected person, animal, arthropod, environmental exposure or other source.
2.12. Department - The West Virginia department of health and human resources.
2.13. Electronic laboratory reporting – Reporting of laboratory data to the West Virginia Health Information Network (WVHIN) or the West Virginia Electronic Disease Surveillance System (WVEDSS) by use of HL7 messaging standards.
2.14. Extensible Markup Language (XML) - A markup language that defines a set of rules for encoding documents in a format that is both human-readable and machine-readable.
2.15. Epidemic - An outbreak or the occurrence of more cases of disease than expected in a given area among a specific group of people over a particular period of time.
2.16. Epidemiologic Information - Medical and risk factor data or other information, interviews, investigative reports, other records and notes collected during the course of an epidemiologic investigation of a disease, condition, or outbreak.
2.17. Epidemiologic Investigation - An investigation to determine the distribution, determinants and risk factors for disease in a specified population, for the purpose of prevention or control of the disease in the population; or to evaluate prevention and control efforts; or for increased understanding of the effects of the disease on the population.
2.18. Foodborne outbreak - An incident in which two or more persons experience a similar illness after ingestion of a common food, and epidemiologic analysis implicates the food as the source of the illness.
2.19. Health care provider - Any physician, dentist, nurse, or other individual who provides medical, dental, nursing, or other health care services of any kind to individuals.
2.20. Health care facility - Any hospital, nursing home, clinic, cancer treatment center, laboratory, or other facility which provides health care or diagnostic services to individuals, whether public or privately owned.
2.21. Health level 7 (HL7) messaging – Consensus standards for sharing electronic clinical and administrative data between health information systems. HL7 standards are found at: http://hl7.org.
2.22. Health or Safety Emergency – As defined under the Family Educational Rights and Privacy Act’s (FERPA) health or safety emergency provision. “Health or Safety Emergency Situation” may include an outbreak of infectious disease occurring in a school or a case of reportable disease in a school that may be transmitted by casual contact in a school or community setting.
2.23. Healthcare Associated Infection (HAI) – Infections caused by a wide variety of common and unusual bacteria, fungi and viruses during the course of receiving medical care.
2.24. Hospital - A facility licensed as a hospital under WV Division of Health Legislative Rule, Hospital Licensure, 64 CSR 12.
2.25. Infectious Agent - A biological organism such as a bacteria, parasite or virus; or a bacterial toxin; or a prion capable of causing disease in animals or man when introduced into the individual through water, air, food, the environment or by the percutaneous or other route.
2.26. Intentional Exposure - The deliberate introduction of a harmful agent into the air, water, food or environment of an individual or group of individuals with the intent of causing disease.
2.27. International Society for Disease Surveillance (ISDS) – A 501(c)(3) nonprofit organization founded in 2005 and dedicated to the improvement of population health by advancing the science and practice of disease surveillance. Information is available at: http://www.syndromic.org /.
2.28. Isolate – A pure culture of a bacteria, usually identified by a clinical laboratory from culture of a specimen from a patient. Isolates are usually stored on an agar plate or slant or in nutrient broth.
2.29. Isolation - The separation of infected persons or animals from other persons or animals, under the necessary time frame and conditions to prevent the direct or indirect transmission of the infectious agent from the infected persons or animals to other persons or animals who are susceptible or who may spread the disease to others.
2.30. Laboratory - Any licensed facility or place, however named, for the biologic, microbiologic, serologic, virologic, chemical, hematologic, immuno-hematologic, biophysical, cytologic, pathologic, genetic, molecular or other examination of materials for the purpose of providing medical or epidemiologic information for the diagnosis, prevention or treatment of any disease, or the assessment of the health of human beings. The term "laboratory" includes both public and private laboratories, free-standing laboratories, and hospital laboratories.
2.31. Law Enforcement Personnel - Any person who is employed by a local, county, state or federal agency with law enforcement responsibilities.
2.32. Local Board of Health - A board of health serving one or more counties, one or more municipalities, or a combination thereof.
2.33. Local Health Department - The staff of the local board of health.
2.34. Local Health Officer - The individual who fulfills the duties and responsibilities of the health officer for a local board of health, or his or her designee.
2.35. Medical Information - Data or other information regarding the history, examination, radiological or laboratory findings, diagnosis, treatment, or other clinical care for a person examined or treated for a suspected or actual disease.
2.36. National Healthcare Surveillance Network (NHSN) – A secure, internet-based surveillance system for patient and healthcare personnel safety systems managed by the Division of Healthcare Quality Promotion (DHQP) at the Centers for Disease Control and Prevention (hereinafter CDC). Enrollment is open to all types of health care facilities in the United States, including acute care hospitals, long term acute care hospitals, psychiatric hospitals, rehabilitation hospitals, outpatient dialysis centers, ambulatory surgery centers and long term care facilities. NHSN can accept retrospective reports beginning with January of the year that the facility first enrolled in NHSN.
2.37. Nursing Home - Any facility licensed as a nursing home under WV Legislative Rule, Nursing Home Licensure, 64CSR13, or any extended care facility operated in conjunction with a hospital.
2.38. Outbreak - The occurrence of more cases of disease than expected in a given area among a specific group of people over a particular period of time or an epidemic.
2.39. OLS - The office of laboratory services in the Bureau.
2.40. Physician - An individual licensed to practice medicine by either the board of medicine or the board of osteopathy.
2.41. Placarding - The posting on a home, building or other structure of a sign or notice warning of the presence of a communicable disease or other health hazard and the danger of the disease or hazard within or beyond the placarded home, building or structure.
2.42. Prevention collaborative – A group of health care facilities that are engaged in an effort to reduce Healthcare Associated Infections (hereinafter HAI). Members of the collaborative use a common, though not necessarily identical, approach. The members discuss progress regularly and share lessons learned in real time so that others in the group can benefit from the experience of each facility.
2.43. Quarantine - The limitation of freedom of movement of persons or animals in a time frame and manner to prevent contacts that could lead to spread of disease.
2.44. Real time electronic feed – Automated electronic reporting, usually of laboratory results, such that electronic laboratory reports are routinely delivered to the Bureau within no more than 24 hours after results are available.
2.45. Reportable Disease or Condition - Any disease or condition required to be reported by this rule.
2.46. STD - Sexually transmitted disease.
2.47. Surveillance - The systematic collection, analysis, interpretation and dissemination of health data on an ongoing basis, to gain knowledge of the pattern of disease occurrence and potential in a community; or to understand the disease patterns in the community in order to control and prevent disease in the community, or to evaluate prevention and control efforts.
2.48. Surveillance Region – A grouping of counties for the purposes of aggregating surveillance data and providing coverage by a regional epidemiologist. Surveillance regions are usually self-selected by the counties and are listed at: www.dide.wv.gov.
2.49. Syndromic surveillance – Systematic collection of data from the point of care, usually based on chief complaint data, often without a definitive diagnosis, for the purpose of supplementing other sources of surveillance data.
2.50. Validated Submitter – A laboratory whose transmission of electronic laboratory data to WVHIN or WVEDSS by HL7 messaging has been validated by the Commissioner. Validation involves submission of paper and electronic copies of laboratory data until it is established that electronic reporting is at least as accurate and complete as paper-based reporting.
2.51. Veterinarian - A doctor of veterinary medicine.
2.52. Waterborne outbreak - An incident in which two or more persons experience a similar illness after consumption or use of water and epidemiologic evidence implicates the water as the source of the illness.
2.53. WVEDSS - West Virginia Electronic Disease Surveillance System - An electronic data system for reporting and tracking cases of infectious diseases reported from local health departments and laboratories to the bureau and to the Centers for Disease Control and Prevention (CDC). WVEDSS is part of the national electronic disease surveillance system (NEDSS). WVEDSS may use either HL7 or XML data formats.
2.54. WVHIN – West Virginia Health Information Network – An electronic system for data exchange operated by the West Virginia Healthcare Authority for the purpose of exchanging information between laboratories, health providers and health facilities. WVHIN is capable of receiving HL7 messaging through a real time data feed.
2.55. WVSIIS – West Virginia Statewide Immunization Information System – An electronic registry of immunization information for children and adults for the purpose of maintaining an integrated immunization record for all people in the state. WVSIIS data may be made available to immunization providers, health care providers, public health investigators and school personnel to search immunization records for school entry requirements, with appropriate limits on access. The administration of adult immunization should also be reported to WVSIIS.
2.56. Zoonotic disease –A disease that is potentially transmitted to humans by direct or indirect contact with animals or animal products or by exposure to animals or animal products.
W. Va. Code R. § 64-7-3 Selection, Categorization, and Required Reporting
3.1. Selection and Categorization of Required Reportable Diseases and Conditions.
3.1.a. The Commissioner may, by order filed with the Secretary of State, add or delete a disease or condition in any category. The Commissioner shall select and categorize diseases and conditions for inclusion in this rule based on whether the disease or condition constitutes or has the potential to constitute a public health emergency, whether it requires public health follow up, or whether the collection of data or other information on the disease or condition can assist in either determining the need for or effectively implementing public health programs or other projects to protect and promote the health of the people of West Virginia.
3.1.b. In emergency situations, such as potential epidemics, mass exposures, or mass casualty events, the Commissioner may require same day reporting by all required reporters for selected diseases conditions or injuries by rapid written notification of:
3.1.b.1. local health departments;
3.1.b.2. health care facilities and health care providers;
3.1.b.3. animal health providers, if the disease is zoonotic;
3.1.b.4. laboratories;
3.1.b.5. schools, camps or vessels;
3.1.b.6. emergency shelters;
3.1.b.7. “911” operators and disaster response workers;
3.1.b.8. funeral directors; and
3.1.b.9. medical examiners or coroners.
3.1.c. The written notification shall list required diseases, injuries or conditions to be reported; case definitions to be used; the required time frame for reporting; information to be reported for each case or suspected case; and information on how reports should be made to local health departments or the Bureau. The Commissioner shall establish a time for the required reporting not to exceed the duration of the emergency. Disease and conditions under surveillance may include:
3.1.c.1. fatalities, including cause of death;
3.1.c.2. injuries;
3.1.c.3. exposures to chemicals, toxins or radiation; and
3.1.c.4. other diseases or conditions established by the order of the Commissioner.
3.2. Reporting of Diseases and Conditions.
3.2.a. The Commissioner shall establish specific protocols for reporting diseases and conditions. These may be found in the West Virginia Reportable Diseases Protocol Manual (available online at www.dide.wv.gov ). The protocols shall include any information to be reported beyond that listed in this rule and any additional information necessary regarding reporting or appropriate public health management.
3.2.b. Facilities and providers shall report diseases and conditions to the local health department in the county of residence of the patient on forms provided in the West Virginia Reportable Disease Protocol Manual (available online at: www.dide.wv.gov).
3.2.c. Laboratories shall send a paper copy of the laboratory report to the local health department in the county where the patient resides. When electronic reporting to WVHIN or WVEDSS is validated by the bureau, the laboratory shall report laboratory data in real time by HL7 messaging. When reporting directly to WVEDSS, laboratories may use XML.
3.2.d. Local health departments shall report diseases and conditions to WVEDSS in a manner approved by the Commissioner.
3.3. Category I Reportable Diseases and Conditions.
3.3.a. Health care providers and health care facilities shall report cases of Category I diseases or conditions listed in this section by telephone to the local health department serving the patient’s county of residence immediately; and file a written report as required in the Reportable Disease Protocol Manual (available at: www.dide.wv.gov). Reports from health care providers and health care facilities shall include the patient’s name, address, telephone number, date of birth, sex, race, ethnicity and the patient’s physician’s name, office address, office phone and fax numbers, and any other information requested by the Commissioner relevant to the purposes of this rule.
3.3.a.1. Laboratories shall report cases of Category I diseases or conditions listed in this section by telephone to the local health department serving the patient’s county of residence immediately and follow up with a copy of the written laboratory report. When the laboratory is designated by the Commissioner to be a validated submitter to the WVHIN or WVEDSS, the laboratory may substitute real time electronic laboratory reporting using HL7 messaging for the required paper-based reporting. Reports from laboratories shall include the patient’s name, address, telephone number, date of birth, sex, race, ethnicity; and the physician’s name, office address, office phone and fax numbers; name of person or agency submitting the specimen for testing, specimen source, date of specimen collection, date of result, name of the test, test result, normal value or range; and name, address, phone and fax number of the laboratory. All local health departments shall report the case to the Bureau immediately upon receipt of the laboratory report by calling toll free 1 (800) 423-1271, extension 1, and by filing an electronic report in WVEDSS or as required by the Commissioner.
3.3.b. Category I.A diseases and conditions reportable immediately by health care providers and health care facilities are:
3.3.b.1. Anthrax;
3.3.b.2. Bioterrorist event, suspect or confirmed;
3.3.b.3. Botulism;
3.3.b.4. Foodborne outbreak, suspect or confirmed;
3.3.b.5. Intentional exposure to an infectious agent or biological toxin, suspect or confirmed;
3.3.b.6. Orthopox infection, including smallpox and monkeypox;
3.3.b.7. An outbreak or cluster of any illness or condition - suspect or confirmed;
3.3.b.8. Novel influenza infection, suspect or confirmed, animal or human;
3.3.b.9. Plague;
3.3.b.10. Rubella;
3.3.b.11. Rubella, congenital syndrome;
3.3.b.12. Rubeola (Measles);
3.3.b.13. SARS coronavirus infection, suspect or confirmed;
3.3.b.14. Smallpox;
3.3.b.15. Tularemia;
3.3.b.16. Viral hemorrhagic fevers, including filoviruses such as ebola and Marburg and arenaviruses such as lassa fever; and
3.3.b.17. Waterborne outbreak, suspect or confirmed.
3.3.c. Reports of Category I.A diseases and conditions shall first be reported by phone and also be submitted on standard reporting forms in accordance with the West Virginia Reportable Diseases Protocol Manual (available online at www.dide.wv,gov).
3.3.d. Category I.B diseases and conditions reportable by laboratories are:
3.3.d.1. Bacillus anthracis;
3.3.d.2. Bioterrorist event, suspect or confirmed;
3.3.d.3. Clostridium botulinum, microbiologic or toxicologic evidence;
3.3.d.4. Foodborne outbreak, suspect or confirmed;
3.3.d.5. Francisella tularensis;
3.3.d.6. Intentional exposure to an infectious agent; suspect or confirmed;
3.3.d.7. Novel influenza infection, suspect or confirmed, animal or human;
3.3.d.8. Orthopox infection, virologic, electron microscopic or molecular evidence;
3.3.d.9. Outbreak or cluster of any illness or condition - suspect or confirmed;
3.3.d.10. Rubella, virologic or serologic evidence;
3.3.d.11. Rubeola (measles), virologic or serologic evidence;
3.3.d.12. SARS coronavirus infection, serologic evidence or PCR;
3.3.d.13. Smallpox, virologic or serologic evidence;
3.3.d.14. Viral hemorrhagic fever;
3.3.d.15. Waterborne outbreak, suspect or confirmed;
3.3.d.16. Yersinia pestis, microbiologic or serologic evidence; and
3.3.d.17. Any other laboratory evidence suggestive of current infection with any of the diseases or conditions listed in Category I.A.
3.3.e. After reporting by phone, laboratory reports of Category I.B. diseases and conditions shall be submitted to the local health department in accordance with the West Virginia Reportable Disease Protocol Manual (online at: www.dide.wv.gov). A laboratory designated by the Commissioner to be a validated submitter to the WVHIN or WVEDSS may substitute real time electronic laboratory reporting using HL7 messaging for the required paper-based reporting.
3.4. Category II Reportable Diseases and Conditions.
3.4.a. Health care providers and health care facilities shall report cases of Category II diseases or conditions listed in this section by telephone to the local health department serving the patient’s county of residence within 24 hours of diagnosis, and follow up with a written report on standard reporting forms in accordance with the Reportable Disease Protocol Manual (available at: www.dide.wv.gov). Reports from providers shall include the patient’s name, address, telephone number, date of birth, sex, race, ethnicity and the patient’s physician’s name, office address, office phone and fax numbers, and any other information requested by the Commissioner relevant to the purposes of this rule.
3.4.a.1. Laboratories shall report cases of Category II diseases or conditions listed in this section by telephone to the local health department serving the patient’s county of residence within 24 hours of diagnosis, and follow up with a written copy of the laboratory report. A laboratory designated by the Commissioner to be a validated submitter to the WVHIN or WVEDSS may substitute real time electronic laboratory reporting using HL7 messaging for the required paper-based reporting Reports from laboratories shall include the patient’s name, address, telephone number, date of birth, sex, race, ethnicity; and the physician’s name, office address, office phone and fax numbers; name of person or agency submitting the specimen for testing, specimen source, date of specimen collection, date of result, name of the test, test result, normal value or range; and name, address, phone and fax number of the laboratory. All local health departments shall report the case to the Bureau within 24 hours of receipt of the report by filing an electronic report in WVEDSS or as required by the Commissioner.
3.4.b. Category II.A diseases and conditions reportable by health care providers and health care facilities are:
3.4.b.1. Animal bites;
3.4.b.2. Brucellosis;
3.4.b.3. Cholera;
3.4.b.4. Dengue fever;
3.4.b.5. Diphtheria;
3.4.b.6. Haemophilus influenzae, invasive disease;
3.4.b.7. Hemolytic uremic syndrome, postdiarrheal;
3.4.b.8. Hepatitis A, acute, including results of hepatitis serologies, transaminase levels and bilirubin;
3.4.b.9. Hepatitis B, acute, chronic or perinatal, including results of hepatitis A and B serologies, transaminase levels and bilirubin;
3.4.b.10. Hepatitis D including results of hepatitis A and B serologies, transaminase levels and bilirubin;
3.4.b.11. Meningococcal disease, invasive;
3.4.b.12. Mumps, acute infection;
3.4.b.13. Pertussis (whooping cough);
3.4.b.14. Poliomyelitis;
3.4.b.15. Q-fever (Coxiella burnetii);
3.4.b.16. Rabies; human or animal;
3.4.b.17. Shiga toxin-producing Escherichia coli (STEC) including but not limited to E. Coli 0157:H7;
3.4.b.18. Staphylococcus aureus with glycopeptide-intermediate (GISA/VISA) or glycopeptide-resistant (GRSA/VRSA) susceptibilities, including results of susceptibility testing;
3.4.b.19. Tuberculosis all forms, including antibiotic susceptibility patterns;
3.4.b.20. Typhoid fever (Salmonella typhi);
3.4.b.21. Yellow fever; and
3.4.b.22. Any other unusual condition or emerging infectious disease of potential public health importance;
3.4.c. Reports of Category II.A diseases and conditions shall be submitted on reporting forms as listed in the West Virginia Reportable Diseases Protocol Manual (available online at www.dide.wv.gov )
3.4.d. Category II.B diseases and conditions reportable by laboratories are:
3.4.d.1. Bordatella pertussis, microbiologic or molecular evidence;
3.4.d.2. Brucella, microbiologic or serologic evidence;
3.4.d.3. Corynebacterium diphtheriae, microbiologic or histopathologic evidence;
3.4.d.4. Coxiella burnetii;
3.4.d.5. Dengue fever, serologic evidence;
3.4.d.6. Haemophilus influenzae from any normally sterile body site, including results of susceptibility testing;
3.4.d.7. Hepatitis A, positive IgM, including transaminase and bilirubin levels;
3.4.d.8. Hepatitis B, positive anti-HBc IgM or HBsAg, including hepatitis A serologies and transaminase and bilirubin levels;
3.4.d.9. Hepatitis D, positive serology, including hepatitis A and B serologies and transaminase and bilirubin levels;
3.4.d.10. Mumps, evidence of acute infection from any site;
3.4.d.11. Mycobacterium tuberculosis from any site (include drug susceptibility patterns);
3.4.d.12. Neisseria meningitidis from a normally sterile site;
3.4.d.13. Poliomyelitis, virologic or serologic evidence;
3.4.d.14. Rabies, animal or human;
3.4.d.15. Salmonella typhi from any site;
3.4.d.16. Shiga toxin-producing Escherichia coli (STEC) including but not limited to E. Coli 0157:H7;
3.4.d.17. Staphylococcus aureus with glycopeptide-intermediate (GISA/VISA) or glycopeptide-resistant (GRSA/VRSA) susceptibilities, including the results of susceptibility testing;
3.4.d.18. Vibrio cholerae, microbiologic or serologic evidence;
3.4.d.19. Yellow Fever, virologic or serologic evidence;
3.4.d.20. Any other unusual condition or emerging infectious disease of public health importance; and
3.4.d.21. Any other laboratory evidence suggestive of current infection with any of the diseases or conditions listed in Category IIA.
3.4.e. After reporting by phone, the laboratory shall report Category II.B diseases and conditions to the local health department in accordance with the Reportable Disease Protocol Manual (available at: www.dide.wv.gov). A laboratory designated by the Commissioner to be a validated submitter to the WVHIN or WVEDSS may substitute real time electronic laboratory reporting by HL7 messaging for the required paper-based reporting.
3.5. Category III Reportable Diseases and Conditions.
3.5.a. Health care providers and health care facilities shall report cases of Category III diseases and conditions to the local health department serving the patient’s county of residence within seventy-two hours of diagnosis, on reporting forms as listed in the Reportable Disease Protocol Manual (available at: www.dide.wv.gov). Reports from health care providers and health care facilities shall include the patient’s name, address, telephone number, date of birth, sex, race, ethnicity and the patient’s physician’s name, office address, and office phone and fax numbers, and any other information requested by the Commissioner relevant to the purposes of this rule.
3.5.a.1. Laboratories shall report cases to the local health department serving the patient’s county of residence by submitting a copy of the laboratory report. A laboratory designated by the Commissioner to be a validated submitter to the WVHIN or WVEDSS may substitute real time electronic laboratory reporting by HL7 messaging for the required paper-based reporting. Reports from laboratories shall include the patient’s name, address, telephone number, date of birth, sex, race, ethnicity; and the physician’s name, office address, office phone and fax numbers; name of person or agency submitting the specimen for testing, specimen source, date of specimen collection, date of result, name of the test, test result, normal value or range; and name, address, phone and fax number of the laboratory. The local health department shall report the case to the Bureau within 72 hours of receiving the report by filing an electronic report with WVEDSS in accordance with guidance in the Reportable Disease Protocol Manual.
3.5.b. Category III.A diseases and conditions reportable by health care providers and health care facilities are:
3.5.b.1. Campylobacteriosis;
3.5.b.2. Cryptosporidiosis;
3.5.b.3. Cyclospora;
3.5.b.4. Giardiasis;
3.5.b.5. Listeria;
3.5.b.6. Salmonellosis (except Typhoid Fever), including results of susceptibility testing;
3.5.b.7. Shigellosis, including the results of susceptibility testing;
3.5.b.8. Trichinosis; and
3.5.b.9. Vibriosis.
3.5.c. Reports of Category III.A diseases and conditions are reported on reporting forms as listed in the West Virginia Reportable Diseases Protocol Manual (available online at www.dide.wv.gov).
3.5.d. Category III.B diseases and conditions reportable by laboratories are:
3.5.d.1. Campylobacter species;
3.5.d.2. Cryptosporidium;
3.5.d.3. Cyclospora;
3.5.d.4. Giardia lamblia, microscopic or immunodiagnostic evidence;
3.5.d.5. Listeria monocytogenes;
3.5.d.6. Salmonella (any species, excluding Salmonella typhi), including the results of susceptibility testing;
3.5.d.7. Shigella (any species), including the results of susceptibility testing;
3.5.d.8. Trichinella, demonstration of cysts or serologic evidence;
3.5.d.9. Non-cholera Vibrio species; and
3.5.d.10. Any other laboratory evidence suggestive of current infection with any of the diseases or conditions listed in Category III.A.
3.5.e. Laboratory reports of Category III.B. diseases and conditions shall be submitted to the local health department in accordance with the West Virginia Reportable Diseases Protocol Manual (available online at www.dide.wv.gov). A laboratory designated by the Commissioner to be a validated submitter to the WVHIN or WVEDSS may substitute real time electronic laboratory reporting by HL7 messaging for the required paper-based reporting.
3.6. Category IV Reportable Diseases and Conditions.
3.6.a. Health care providers and health care facilities shall report cases of Category IV diseases or conditions to the local health department serving the patient’s county of residence within one week of diagnosis, by filing a written report with the local health department in the county of residence of the patient. Reports from health care providers and health care facilities shall include the patient’s name, address, telephone number, date of birth, sex, race, ethnicity, the patient’s physician’s name, office address and office phone and fax, and any other information requested by the Commissioner relevant to the purposes of this rule.
3.6.a.1. Laboratories shall report to the local health department in the patient’s county of residence through a written copy of the laboratory report. A laboratory designated by the Commissioner to be a validated submitter to the WVHIN or WVEDSS may substitute real time electronic laboratory reporting by HL7 messaging for the required paper-based reporting. Reports from laboratories shall include the patient’s name, address, telephone number, date of birth, sex, race, ethnicity; and the physician’s name, office address, office phone and fax numbers; name of person or agency submitting the specimen for testing, specimen source, date of specimen collection, date of result, name of the test, test result, normal value or range; and name, address, phone and fax number of the laboratory. The local health department shall file an electronic report with WVEDSS within one week of receiving the report from a provider, facility or laboratory.
3.6.b. Category IV.A diseases reportable by health care providers and health care facilities are:
3.6.b.1. Anaplasmosis;
3.6.b.2. Arboviral infection;
3.6.b.3. Babesiosis;
3.6.b.4. Chickenpox (numerical totals only);
3.6.b.5. Erlichiosis;
3.6.b.6. Hantavirus pulmonary syndrome;
3.6.b.7. Influenza-like illness (numerical totals only);
3.6.b.8. Influenza-related death in an individual less than 18 years of age;
3.6.b.9. Legionellosis;
3.6.b.10. Leptospirosis;
3.6.b.11. Lyme disease;
3.6.b.12. Malaria;
3.6.b.13. Psittacosis;
3.6.b.14. Rocky Mountain spotted fever;
3.6.b.15. Streptococcal disease, invasive Group B;
3.6.b.16. Streptococcal toxic shock syndrome;
3.6.b.17. Streptococcus pneumoniae, invasive disease, (include antibiotic susceptibility patterns);
3.6.b.18. Tetanus;
3.6.b.19. Toxic shock syndrome; and
3.6.b.20. Tuberculosis, latent infection (limited to individuals with a positive Mantoux tuberculin skin test conversion in the last two years or any positive Mantoux tuberculin skin test in a child less than five years of age).
3.6.c. Reports of Category IV.A diseases and conditions are reported on reporting forms as listed in the West Virginia Reportable Diseases Protocol Manual (available online at www.dide.wv.gov).
3.6.d. Category IV.B conditions reportable by laboratories are:
3.6.d.1. Anaplasmosis phagocytophilum, laboratory evidence;
3.6.d.2. Arboviral infection, virologic, serologic, or other evidence;
3.6.d.3. Babesia species, laboratory evidence;
3.6.d.4. Borrelia burgdorferi from culture, or diagnostic levels of IgG or IgM, (with Western blot confirmation);
3.6.d.5. Carbapenem-resistant Enterobacteriaceae (carbapenem-resistant Escherichia coli and Klebsiella pneumonia);
3.6.d.6. Ehrlichia species, serologic or other laboratory evidence;
3.6.d.7. Hantavirus infection, serologic, PCR, immunohistochemistry, or other evidence;
3.6.d.8. Legionella, bacteriologic or serologic evidence;
3.6.d.9. Leptospirosis, laboratory evidence;
3.6.d.10. Malaria organisms on smear of blood;
3.6.d.11. Psittacosis, microbiologic or serologic evidence;
3.6.d.12. Rocky Mountain spotted fever, serologic evidence;
3.6.d.13. Streptococcus, Group B, from a normally sterile site;
3.6.d.14. Streptococcus pneumoniae, from a normally sterile site (include antibiotic susceptibility patterns on all isolates); and
3.6.d.15. Any other laboratory evidence suggestive of current infection with any of the diseases or conditions listed in Category IV.A.
3.7. Category V Reportable Diseases and Conditions.
3.7.a. Health care providers and health care facilities shall report Category V diseases and conditions by filing a written report with the Bureau within one week of diagnosis unless otherwise indicated. Reports shall include the patient's name, address, telephone number, date of birth, sex, race, ethnicity, the patient’s physician’s name, office address, and office phone and fax, and any other information requested by the Commissioner relevant to the purposes of this rule.
3.7.a.1. Laboratories shall report Category V conditions through a written copy of the laboratory report. A laboratory designated by the Commissioner to be a validated submitter to WVHIN or WVEDSS may substitute real time electronic laboratory reporting using HL7 standards for the required paper-based reporting. Reports from laboratories shall include the patient’s name, address, telephone number, date of birth, sex, race, ethnicity; the physician’s name, office address, office phone and fax numbers; name of person or agency submitting the specimen for testing, specimen source, date of specimen collection, date of result, name of the test, test result, normal value or range; and name, address, phone and fax number of the laboratory. The Commissioner may request that local health departments complete an investigation of the disease or condition using WVEDSS.
3.7.b. Category V.A diseases and conditions reportable by health care providers and health care facilities are:
3.7.b.1. AIDS diagnosed from the presence of AIDS defining diseases or conditions (including previously reported HIV positive individuals), according to the time frame in the Bureau rule, “AIDS Related Medical Testing and Confidentiality”, 64CSR64 **.
3.7.b.2. Autism spectrum disorder; reportable to researchers at Marshall University Autism Training Center at (800)-344-5115 or (304) 696-2332 or http://www.marshall.edu/wvasdr/
3.7.b.3. Birth defects, including Down’s syndrome;
3.7.b.4. Cancer, including non-malignant intracranial and central nervous system tumors, in time frame noted in the Bureau rule, “Cancer Registry,” 64CSR68;
3.7.b.5. Chancroid;**
3.7.b.6. Chlamydia;**
3.7.b.7. Gonococcal disease** -- conjunctivitis in the newborn or drug-resistant disease (within 24 hours);
3.7.b.8. Gonorrhea (all other sites);**
3.7.b.9. Hemophilia;
3.7.b.10. Hepatitis C, acute, including results of hepatitis A and B serologies and transaminase and bilirubin levels;
3.7.b.11. HIV (Human Immunodeficiency Virus) according to the time frame in the Bureau rule, “AIDS Related Medical Testing and Confidentiality”, 64CSR64;**
3.7.b.12. Lead, all blood lead test results;
3.7.b.13. Pelvic inflammatory disease;**
3.7.b.14. Syphilis (late latent, late symptomatic, or neurosyphilis);** and
3.7.b.15. Syphilis** -- primary, secondary, early latent (less than one (1) year), or congenital (all within 24 hours).
3.7.c. Reports of Category V.A. diseases and conditions are submitted on forms as specified in the West Virginia Reportable Diseases Protocol Manual (available online at www.dide.wv.gov).
3.7.d. Category V.B. diseases and conditions reportable by laboratories are:
3.7.d.1. All CD4+ T-lymphocyte or percentages according to the time frame in the Bureau rule, “AIDS Related Medical Testing and Confidentiality”, 64CSR64.
3.7.d.2. Chlamydia trachomatis by culture, antigen, DNA probe methods, or other positive laboratory evidence;*;
3.7.d.3. Down's Syndrome chromosomal anomaly;
3.7.d.4. Enterovirus (non-polio), culture confirmed, (numerical totals only, by serotype as available, and including echovirus, coxsackievirus, and parechovirus);
3.7.d.5. Haemophilus ducreyi;**
3.7.d.6. Hepatitis C, virologic or serologic evidence, including results of hepatitis A and B serologies and transaminase and bilirubin levels;
3.7.d.7. HIV (Human Immunodeficiency Virus) Type 1 or 2, confirmed antibody or virus detection test (serology, culture, antigen, PCR, DNA, RNA probe, etc.), according to the time frame in the Bureau rule, “AIDS Related Medical Testing and Confidentiality”, 64CSR64;**
3.7.d.8. Influenza, confirmed by culture, PCR or immunofluorescence, (numerical totals only, by type of test performed, and by influenza type and subtype);
3.7.d.9. Lead, all blood lead test results;
3.7.d.10. Mycobacterium tuberculosis from any site** (include drug susceptibility patterns) (within 24 hours);
3.7.d.11. Neisseria gonorrheae (drug resistant) from any site** (within 24 hours);
3.7.d.12. Neisseria gonorrheae from female upper genital tract** (within 24 hours);
3.7.d.13. Neisseria gonorrheae from the eye of a newborn** (within 24 hours);
3.7.d.14. Neisseria gonorrheae**, culture or other positive laboratory evidence, (all other);
3.7.d.15. Syphilis**, serologic evidence;
3.7.d.16. Treponema pallidum, positive dark-field examination** (within 24 hours); and
3.7.d.17. Any other laboratory evidence suggestive of current infection with any of the diseases or conditions listed in Category V.A.
3.7.e. Reports of Category V diseases and conditions marked with two (2) asterisks (**) shall be made on the appropriate STD/HIV/AIDS and TB report forms provided by the Bureau, until such time as these diseases can be reported electronically using the WVEDSS.
W. Va. Code R. § 64-7-4 Other Reportable Events: Birth Defects
The Commissioner shall arrange for the reporting of birth defects as soon as detected by pediatric health care providers or human genetic services providers. Birth defects are also identified from birth certificates and health care facility medical records. After case review, evaluation and referrals, reports are consolidated in the Maternal and Child and Family Health database. The Bureau shall provide appropriate report forms for this reporting.
W. Va. Code R. § 64-7-5 Other Reportable Events: Potentially Rabid Animal Bites, Rabid Animals, Rabies Pre-Exposure Vaccinations and Post-Exposure Prophylaxis
5.1. If a person is bitten, scratched, or otherwise exposed (gets saliva, neural tissue, or other potentially infectious fluid into an open cut, wound, or mucous membrane) to a terrestrial mammal or bat, then the incident, including the person’s full name, date of birth, and address, shall be reported to the local health officer within 24 hours, by phone, or other rapid means of communication, by the following individuals:
5.1.a. The physician or other health care provider caring for or observing the person;
5.1.b. The veterinarian or animal health care provider;
5.1.c. The humane or animal control officer;
5.1.d. The person bitten, scratched, or otherwise exposed, if no physician or other health care provider is in attendance and the person bitten, scratched or otherwise exposed is an adult;
5.1.e. Whoever is caring for the person, if no physician or other health care provider is in attendance and the person bitten, scratched, or otherwise exposed is incapacitated; or
5.1.f. The parent or guardian, if no physician or other health care provider is in attendance and the person bitten, scratched or otherwise exposed is a child.
5.2. The local health officer shall report within 24 hours or one working day to the Commissioner the name, date of birth, address, circumstances of the exposure, and action taken for every person bitten, scratched, or otherwise exposed to an animal which has or is suspected of having rabies.
5.3. If the animal is a domestic dog, cat or ferret, the local health officer shall make a reasonable attempt to determine the animal's owner, and, if successful, shall direct the owner to confine the animal for a period of ten days. The owner of the dog, cat or ferret, county humane officer, dog warden or sheriff shall notify the local health officer immediately if the animal shows symptoms compatible with rabies or dies, and the local health officer, county humane officer, dog warden or sheriff shall arrange for appropriate examination of the animal’s brain at the office of laboratory services. If the bite is to the head, face or neck or is unusually severe or results in hospitalization or death or if the animal is unlikely to have an owner at the end of the 10 day observation period, the local health officer may request that the animal be humanely destroyed and arrange for appropriate examination of the animal’s brain at the OLS.
5.4. After a reasonable attempt to identify the owner of the animal, if the local health officer cannot determine the owner of the domestic dog, cat or ferret, he or she shall direct the county humane officer, dog warden or sheriff to pick up the suspect dog, cat or ferret, that has bitten a person and confine it in isolation for a period of ten days. If the animal shows symptoms compatible with rabies, including if the animal bit someone without provocation, or if the animal demonstrates aggressive behavior toward human beings such that the animal may pose a continuing risk to other people, the local health officer shall direct the county humane officer, dog warden, sheriff, or other designee to humanely destroy the animal and arrange for appropriate examination of the animal’s brain. If the animal dies, the local health officer shall arrange for appropriate examination of the animal’s brain at the office of laboratory services. If the bite is to the head, face or neck or is unusually severe or results in hospitalization or death or if the animal is unlikely to have an owner at the end of the 10 day observation period, the local health officer may request that the animal be humanely destroyed and arrange for appropriate examination of the animal’s brain at the OLS.
5.5. If a person is reported bitten by any mammal other than a domestic dog, cat or ferret, especially a terrestrial mammalian carnivore, such as a raccoon, fox, skunk, coyote, bobcat or other similar species or hybrid, the local health officer may direct the county humane officer, dog warden, sheriff, or other designee to have the animal humanely destroyed immediately and to arrange for appropriate examination of the animal’s brain at the OLS.
5.6. Any person who becomes aware of the existence of an animal apparently afflicted with rabies shall report the existence of the animal, the place where it was last seen, the owner's name, if known, and the symptoms suggesting rabies to the local health officer immediately.
5.7. Health care providers, health care facilities, and other facilities administering rabies post-exposure prophylaxis shall report vaccinations and treatment administered to the local health department. The local health officer shall report animal bites and rabies post-exposure prophylaxis in WVEDSS.
W. Va. Code R. § 64-7-6 Other Reportable Events: Administration of Immunizations
6.1. The Commissioner shall establish and maintain a centralized registry – West Virginia Statewide Immunization Information System – WVSIIS - for tracking compliance with nationally recommended immunization schedules, school entry requirements and for monitoring vaccine use.
6.2. WVSIIS is an electronic reporting system. The following persons shall report immunizations administered to WVSIIS, as required by this rule;
6.2.a. Health care providers;
6.2.b. Health care facilities;
6.2.c. Local Health Officers;
6.2.d. Pharmacists;
6.2.e. Any other providers or facilities administering immunizations; and
6.2.f. School officials, if newly enrolled students present vaccination records for school entry as required by W. Va. Code §16-3-4 and 64CSR95 and those vaccination records are not already recorded in WVSIIS.
6.3. Administration of immunizations against the following diseases are reportable: diphtheria, whooping cough, tetanus, polio, measles, mumps, rubella, hepatitis B, hepatitis A, Haemophilus influenzae type b disease, chickenpox, pneumococcal diseases, meningococcal diseases, rotavirus, influenza, human papilloma virus (HPV) and any additional immunizations required by the Commissioner for public health purposes as published by an order filed with the secretary of state.
6.4. All immunizations administered to persons eighteen years of age and under shall be reported to the immunization registry within two weeks of the administration of the immunization. The entities listed in subsection 6.2. of this section are strongly encouraged to report all immunizations for persons of all ages to maintain an accurate and useful database of all immunization information.
6.5. The Commissioner shall publish detailed instructions for WVSIIS for entities required to report as set forth in subsection 6.2. of this section. The instructions will be available on immunization.wv.gov The instruction shall contain:
6.5.a. A full description of required data elements;
6.5.b. Electronic transmission standards.
6.6. Immunization data that must be reported to the department is confidential, except it may be shared with other health care providers, or other entities with a legally defined access to the data, who are enrolled in the system, without the specific consent of the parent or patient. The data shall only be used for the ongoing care of the patient to assess immunization status, to determine immunization coverage rates, to assist in outbreak investigations or for other purposes determined by the Commissioner.
6.7. Local health officers and other health care providers identified by the state health officer as smallpox vaccination clinics and charged with the responsibility of providing and administering smallpox vaccinations shall report smallpox vaccine administration information to the state health officer through the first responder immunization tracking system within 24 hours.
6.8. In the event of an influenza or other pandemic or a bioterrorist event or intentional exposure to an infectious agent, local health departments or other health care providers charged with administering prophylactic medication or vaccinations shall report administration to the Commissioner via an electronic database within 24 hours of the administration of the prophylactic medication or vaccination.
6.9. All of the data in WVSIIS is confidential and exempt from disclosure. In certain circumstances WVSIIS may release immunization information to the following:
6.9.a. A licensed physician, a licensed health care facility or other licensed health care provider in the state of West Virginia for the purpose of delivering medical or immunization services or for the purpose of identifying under-vaccinated persons;
6.9.b. A local health department for the purposes of delivering medical or immunization services or investigating or managing an outbreak or other reportable disease;
6.9.c. A school official for the purpose of determining if enrolled children have all of the immunizations required by W. Va. Code §§16-3-4 and the Bureau’s rule, Immunization Requirements and Recommendations for New School Enterers, 64CSR95, or for the prevention or control of vaccine-preventable disease within the school; and
6.9.d. Other appropriate persons for public health purposes and to prevent or control the spread of communicable disease.
W. Va. Code R. § 64-7-7 Other Reportable Events: Disease Outbreaks or Clusters
7.1. When a health care facility, health care provider laboratory, school, daycare, camp, vessel, correctional facility or other facility becomes aware of an outbreak or cluster in a community, school, camp, daycare, health care facility, correctional facility or other facility or related to a restaurant or food establishment, it shall report the outbreak to the local health officer immediately.
7.2. When the local health officer becomes aware of an outbreak in his or her jurisdiction, he or she shall notify the Bureau immediately by calling toll-free (800) 423-1271.
7.3. As appropriate, the local health officer shall collaborate in investigation of the outbreak or cluster with:
7.3.a. Other local health officers if cases from other local health jurisdictions are identified;
7.3.b. Public health officials from other states if cases from those states are identified;
7.3.c. The department; and
7.3.d. Federal public health officials.
7.4. An appropriate investigation generally includes:
7.4.a. Establishment of the existence of the outbreak;
7.4.b. Confirmation of the diagnosis, including obtaining appropriate laboratory examinations of cases;
7.4.c. Formulation of an appropriate case definition;
7.4.d. Case-finding, to include:
7.4.d.1. Notification of laboratories and providers in the jurisdiction to identify and report additional cases; or
7.4.d.2. Notification of the school, camp, daycare, health care facility or food establishment or other facility or location to identify and report additional cases; or
7.4.d.3. Public notification to identify and report additional cases, only if other means of case-finding are not feasible;
7.4.e. Systematic collection of demographic, clinical, laboratory and epidemiological information on the cases;
7.4.f. Formulation and implementation of control measures to stem the spread of the outbreak;
7.4.g. Formulation and implementation of special studies to determine the source of the outbreak;
7.4.h. Summarization of the findings of the outbreak investigation in written form; and
7.4.i. Ongoing surveillance to establish that the outbreak is over.
7.5. In the process of outbreak investigation, the Commissioner, in collaboration with the local health officer, may perform epidemiological studies, including case-control, cross-sectional and cohort studies which involve interviews and evaluations of ill persons and well persons. Interviews and evaluations of ill and well persons are confidential and not discoverable under the state freedom of information act, W. Va. Code §29B-1-1, et seq. Information may only be released in aggregate for the purpose of informing the public of the conclusions of the investigation.
7.6. In the process of outbreak investigation, the Commissioner, in collaboration with the local health officer, may request laboratory studies on ill persons and/or well persons including persons suspected of being exposed to or carrying an infectious agent. Laboratory results obtained on ill and well persons are confidential and not discoverable under the state freedom of information act, W. Va. Code 29B-1-1 et seq. Information may only be released in aggregate for the purposes of informing the public of the conclusions of the investigation.
7.7. The Commissioner or the local health officer shall not disclose the identity of the community, school, camp, daycare, health care facility, restaurant or food establishment or other setting where an outbreak or cluster of disease occurs, unless the release is necessary to inform the public to take preventive action to stop the spread of disease or to notify providers or laboratories to identify additional cases of disease. Data on community outbreaks and clusters may be released by the Commissioner in aggregate on a regular basis, identifying the county of occurrence of the outbreak or cluster. Data on healthcare-associated outbreaks and clusters may be released by the Commissioner in aggregate on a regular basis, identifying the surveillance region of occurrence of the outbreak or cluster.
7.8. If the Commissioner becomes aware of an ongoing risk to public health through investigation of an outbreak in a health care facility and the health care facility fails to take appropriate corrective action within a reasonable period of time after notification by the Commissioner, the Commissioner shall file a complaint with the Office of Health Facilities Licensure and Certification. If the Commissioner becomes aware that a licensed practitioner is practicing in such a way as to place the health of the public at risk and the licensed practitioner fails to take appropriate corrective action within a reasonable period of time after notification by the Commissioner, the Commissioner shall file a complaint with the practitioner’s licensing board.
7.9. During the course of an outbreak or exposure investigation, if the Commissioner learns of patient who may have been exposed to a serious infectious condition, such as, but not limited to, hepatitis B or C or human immunodeficiency virus (HIV), and the health of the patient or their family members or close contacts may be at risk, the Commissioner shall notify the patient of the nature of the exposure or possible exposure and action that may be taken by the patient to prevent further risk to their health or the health of their family members or close contacts. In the course of notification of the patient, the Commissioner may identify a health care provider or health care facility to the extent necessary to inform the patient of the nature of the exposure or possible exposure.
W. Va. Code R. § 64-7-8 Other Reportable Events: Surveillance Evaluation and Special Studies
8.1. As necessary, the Commissioner may conduct special studies to evaluate the completeness, timeliness and accuracy of the surveillance and epidemiological information reported under this rule. In the process of conducting surveillance evaluation, the Commissioner may request any of the following information from providers, facilities, laboratories, or other individuals named in this rule:
8.1.a. Computerized or paper reports of cases diagnosed during a limited timeframe, usually during a one year interval, but not more than five years;
8.1.b. Specified laboratory results collected over a limited timeframe, usually during a one year interval, but not more than five years;
8.1.c. Access to records to perform audits for completeness, accuracy and timeliness of reporting, or
8.1.d. Any other information required to verify the completeness and accuracy of reporting.
8.2. In addition, the Commissioner may conduct special studies on the health of the population for the purposes of quantifying the risk to the population or access to appropriate prevention and control services or validating information collected through surveillance data. Studies may include cross-sectional studies, case-control studies, cohort studies or other similar study designs where ill and well persons are evaluated or interviewed or information is collected on these individuals. All information collected in these studies, whether on ill or well persons is confidential and not discoverable under the state freedom of information act, W. Va. Code 29B-1-1, et seq. Information may be released in aggregate for the purposes of informing the public about the health risk or the quality of the surveillance system.
W. Va. Code R. § 64-7-9 Other Reportable Events: Healthcare Associated Infections (HAIs) Surveillance
9.1. The WV Health Care Authority (HCA) shall allow access to all healthcare associated infection (HAI) data reported to and collected by the HCA to the appropriate persons at the Bureau for Public Health in the Office of Epidemiology and Prevention Services. The purpose of the access includes monitoring and reporting the prevalence of antimicrobial resistance in association with specific HAIs, investigation of outbreaks and clusters in healthcare settings and other public health surveillance and investigation activities consistent with the mission of the Bureau. The responsibility for communication with hospitals regarding data collection, data quality and completeness rests with the WV Health Care Authority.
9.2. If not already reportable to the Bureau under subsection 9.1. of this section, all healthcare associated infections designated as reportable to the Center for Medicare and Medicaid Services (CMS) to the National Healthcare Safety Network (NHSN) shall also be made available to the Bureau. The health care facility shall give the Bureau access to the data reported to NHSN. The purpose of the access includes monitoring and reporting the prevalence of antimicrobial resistance in association with specific HAIs, investigation of outbreaks and clusters in healthcare settings and other public health surveillance and investigation activities consistent with the mission of the Bureau. The responsibility for communication with the healthcare facilities regarding data collection, data quality and completeness rests with the Office of Epidemiology and Prevention Services within the Bureau for Public Health.
9.3. Data reported to the Bureau under this section is confidential and not subject to disclosure under the state Freedom Of Information Act, W. Va. Code 29B-1-1, et seq. Data may be released for the purpose of informing the public about the health issue under surveillance in the aggregate.
W. Va. Code R. § 64-7-10 Other Reportable Events: Bioterrorism Response
10.1. All health care providers, health care facilities, animal health care providers, laboratories and law enforcement personnel shall report suspected or confirmed disease due to a bioterrorism agent immediately by telephone with follow up by other rapid means of notification to the local health department in the jurisdiction where the bioterrorist event is identified.
10.2. Suspect disease due to bioterrorism agents may be identified by the following epidemiological findings:
10.2.a. Unusual temporal or geographic clustering of illness. This might include persons who attended the same public event or gathering, or patients presenting with clinical signs and symptoms that suggest an infectious disease outbreak. More than two persons presenting with an unexplained febrile illness associated with sepsis, pneumonia, respiratory failure, rash or a botulism-like syndrome with flaccid paralysis, especially if occurring in otherwise healthy persons;
10.2.b. An unusual age distribution for common diseases, such as an increase in what appears to be a chickenpox like illness among adult patients, but which might be smallpox;
10.2.c. A large number of cases of acute flaccid paralysis with prominent bulbar palsies, suggestive of a release of botulinum toxin;
10.2.d. A laboratory finding characteristic of one of the known bioterrorism agents;
10.2.e. An unusually high number of laboratory samples, particularly from the same biologic medium, such as blood or stool cultures;
10.2.f. Unusual requests for testing or culturing; or
10.2.g. Any other unusual medical, laboratory or epidemiological findings not consistent with known patterns of transmission of naturally-occurring infectious agents.
10.3. Bioterrorism agents may include, but are not limited to:
10.3.a. Anthrax (Bacillis anthracis);
10.3.b. Botulism (Clostridium botulinum toxin);
10.3.c. Brucellosis (Brucella species);
10.3.d. Epsilon toxin of Clostridium perfringens;
10.3.e. Food safety threats (e.g., Salmonella species, Escherichia coli O157:H7, Shigella);
10.3.f. Glanders (Burkholderia mallei);
10.3.g. Melioidosis (Burkholderia pseudomallei);
10.3.h. Plague (Yersinia pestis);
10.3.i. Psittacosis (Chlamydia psittaci);
10.3.j. Q fever (Coxiella burnetii);
10.3.k. Ricin toxin from Riccinus communis (castor beans);
10.3.l. Smallpox (variola major);
10.3.m. Staphylococcal enterotoxin B;
10.3.n. Tularemia (Francisella tularensis);
10.3.o. Typhus fever (Rickettsia prowazekii);
10.3.p. Viral encephalitis (alphaviruses [e.g., Venezuelan equine encephalitis, eastern equine encephalitis, western equine encephalitis]);
10.3.q. Viral hemorhagic fevers (filoviruses [e.g., Ebola, Marburg] and arenaviruses [e.g., Lassa, Machupo]);and
10.3.r. Water safety threats, such as Vibrio cholerae, Cryptosporidium parvum.
10.4. In the event of a suspected or confirmed bioterrorist event, the Commissioner may designate a disease or condition as immediately reportable by direct notification of local health departments and/or health care providers by any rapid means available. In that situation, the Commissioner may request the reporting of cases by phone or by filing an electronic report with WVEDSS.
10.5. The local health officer, on notification of a suspected or confirmed bioterrorist event shall immediately notify the Bureau by phone 1(800) 423-1271 or (304) 558-5358. The local health officer shall also report cases by using WVEDSS.
10.6. As appropriate, the local health officer shall collaborate in an investigation of the bioterrorist event with:
10.6.a. Other local health officers if cases from other local health jurisdictions are identified;
10.6.b. Public health officials from other states if cases from those states are identified;
10.6.c. The department;
10.6.d. Federal public health officials; and
10.6.e. Law enforcement personnel.
10.7. The local health officer shall collaborate in an epidemiological investigation of the bioterrorist event, usually to include a complete outbreak investigation as described in section seven (7) of this rule.
10.8. The Commissioner shall collaborate with the Federal Bureau of Investigation and other federal, state and local law enforcement, emergency responders and other public safety representatives to develop and use a protocol for sharing information on an investigation.
10.8.a. Information may only be shared if the Commissioner determines that sharing such information is critical to protecting the public’s health.
10.8.b. Any information shared shall be protected from further disclosure in a manner consistent with state and federal law and regulations and in accordance with the protocol agreed upon by all parties.
W. Va. Code R. § 64-7-11 Electronic Laboratory Reporting
11.1. Laboratories participating in WVHIN shall report laboratory data to WVHIN by HL-7 messaging. Until the laboratory is designated by the bureau as a validated submitter, the laboratory shall submit laboratory reports to the Bureau by paper in the time frame required. When the laboratory is designated as a validated submitter by the Commissioner, the laboratory may substitute electronic reporting to WVHIN or WVEDSS through HL-7 in real time for the required paper reporting. When the laboratory is designated a validated submitter they shall report the conditions listed in this subsection through a real time electronic feed. These conditions are in addition to conditions reportable in this rule. Reports from laboratories shall include the patient’s name, address, telephone number, date of birth, sex, race and ethnicity; the name of the person or agency submitting the specimen for testing; the specimen source and date of specimen collection; the date of result, name of the test, test result, normal value or range; and the name, address, phone and fax number of the laboratory. Conditions to be reported include:
11.1.a. Adenovirus, laboratory evidence of acute infection;
11.1.b. Enterovirus (non-polio), laboratory evidence of acute infection;
11.1.c. Human metapneumovirus, laboratory evidence of acute infection;
11.1.d. Influenza, laboratory evidence of acute infection, including type and subtype, as available;
11.1.e. Parainfluenza virus, laboratory evidence of acute infection;
11.1.f. Respiratory syncitial virus, laboratory evidence of acute infection; and
11.1.g. Rotavirus, laboratory evidence of acute infection.
W. Va. Code R. § 64-7-12 Syndromic Surveillance
12.1. The Commissioner shall develop a syndromic surveillance system consistent with International Society for Disease Surveillance (ISDS) guidelines. The purpose of the surveillance system is to detect changes in the occurrence of disease in the population, especially as a result of a disease outbreak or other public health emergency, disaster or special event. When the surveillance system is implemented, emergency rooms and urgent care facilities shall transmit data electronically on a schedule determined by the Commissioner, taking into consideration the capacity of the facility to electronically report the data elements, the funding available for implementation, and other relevant factors, including improved efficiencies and resulting benefits to the reporting facility.
12.2. When the syndromic surveillance system is determined to be functional by the Commissioner, emergency rooms and urgent care facilities in the state shall report daily all data elements for each registered patient visit as required by the Commissioner.
12.3. The Commissioner shall publish detailed instructions for emergency departments and urgent care facilities on the required reporting as part of the Reportable Disease Protocol Manual, available online at: www.dide.wv.gov. The instructions shall contain information on:
12.3.a. A full description of required data elements;
12.3.b. Electronic transmission standards;
12.3.c. The transmission schedule; and
12.3.d. The surveillance objectives and other information related to the purpose of the surveillance system and the intended uses of the data.
12.4. None of the following data for patients or their relatives, employers or household members shall be collected by the syndromic surveillance system: names; postal or street address information, other than town or city, county, state, and the first five digits of the zip code; geocode infomation; telephone number; account numbers; certificate or license numbers; vehicle identifiers, and serial numbers, including license plate numbers; device identifiers and serial numbers; web universal resource locators (URLs); internet protocol (IP) address numbers; biometric identifiers, including finger and voice prints; and full face photographic images and any comparable images.
12.5. The Commissioner shall maintain the confidentiality of syndromic surveillance data in accordance with section 20 of this rule. The Commissioner may share the data with local health departments and the Centers for Disease Control and Prevention for public health purposes.
W. Va. Code R. § 64-7-13 Deaths from Reportable Diseases and Conditions; Reportable Diseases and Conditions Diagnosed After Death
13.1. Upon receipt of any death certificate showing a reportable disease or condition, the State registrar of vital statistics shall send a copy of the death certificate to WVEDSS. The State registrar shall report all deaths due to diseases listed in this rule to the Bureau.
13.3 If a pathologist, coroner, medical examiner, physician, other health care provider, or other individual investigating the cause of death determines from the examination of a corpse or from a history of the events leading to death, that at the time of death, the decedent had a disease or condition required to be reported by this rule, he or she shall report the case promptly as required by this rule as if the diagnosis had been established prior to death.
W. Va. Code R. § 64-7-14 Persons, Facilities, and Laboratories Required to Report; Other Related Responsibilities
14.1. Health Care Providers and health care facilities.
14.1.a. Any health care provider who or health care facility which suspects, diagnoses, or cares for a patient with a disease or condition listed in this rule shall:
14.1.a.1. Report the disease or condition as required by this rule;
14.1.a.2. Assist public health officials in appropriate case and outbreak investigation and management and in any necessary contact investigation and management;
14.1.a.3. Make every effort to submit the specimens identified in protocols specified by the Commissioner to establish an accurate diagnosis of the disease or condition to a laboratory approved by the Commissioner;
14.1.a.4. If the disease or condition is communicable, advise, in consultation with State and local public health officials, the patient, and as necessary, members of the patient's household and other patient contacts regarding the precautions to be taken to prevent further spread of the disease. In cases of sexually transmitted diseases, HIV, and tuberculosis, the Bureau recommends that health care providers and health care facilities refer contact notification activities to the STD/HIV/TB program and local health departments for tuberculosis rather than attempt to accomplish the notification themselves;
14.1.a.5. Follow a method of control specified by the Commissioner in established protocols in the West Virginia Reportable Diseases Protocol Manual (available online at www.dide.wv.gov), or by methods developed in consultation with the Commissioner;
14.1.a.6. Assist the Commissioner or the local health officer by promoting implementation of the control method for the disease or condition specified in the protocol with the patient, and, as applicable, members of the patient's household, facility staff, and other involved individuals; and
14.1.a.7. Assist the Commissioner or local health officer in ruling out previously reported cases of infectious disease by submitting copies of negative laboratory tests of medical evaluations.
14.2. Laboratories.
14.2.a. All laboratories, whether public, private or hospital-based, shall report evidence of current infection with the diseases or conditions listed in this rule and shall otherwise comply with the requirements of this rule.
14.2.b. A laboratory which receives a specimen yielding Mycobacterium tuberculosis shall submit the first isolate to the OLS. Additionally, any isolate of M. tuberculosis from a patient collected ninety or more days after the initial specimen shall also be forwarded to the OLS. The laboratory shall perform or arrange for drug susceptibility testing on the initial isolate from each patient from whom M. tuberculosis was isolated and report the results of that drug susceptibility testing to the local health department in the county where the patient resides, within one working day from the time the person or agency who submitted the specimen is notified. If any subsequent culture of M. tuberculosis is found to have developed new patterns of resistance, an additional culture or subculture of the resistant isolate shall be submitted to the OLS. Clinical laboratories that identify acid fast bacillus (AFB) on a smear from a patient shall culture and identify the AFB, or refer these to another laboratory for those purposes.
14.2.b.1. Clinical laboratories that isolate Bacillis anthracis, Clostridium botulinum, Corynebacterium diphtheriae, Tularemia, Salmonella, Shigella, Listeria monocytogenes, or suspect or confirmed shigatoxin-producing E. coli or Yersinia pestis from any patient specimen or Neisseria meningitidis, Streptococcus pneumoniae, or Haemophilus influenzae from a sterile site should submit the first isolate or a subculture of that isolate to the OLS. Laboratories that confirm Campylobacter by non-culture methods shall submit the specimen to the OLS by culture and identification. In addition, the Commissioner may request routine submission of other bacterial isolates by inclusion in the West Virginia Reportable Diseases Protocol Manual (available online at www.dide.wv.gov) and by written notification of laboratories of the specific requirement. During outbreak or other special investigations, the Commissioner may request submission of clinical specimens or isolates from persons with disease during a timeframe specified by the Commissioner.
14.2.b.2. Information that shall be included with any of the specimens listed in this section includes:
14.2.b.2.A. The name, address, and date of birth of the patient;
14.2.b.2.B. The specimen accession number or other unique identifier;
14.2.b.2.C. The date the specimen was obtained from the patient;
14.2.b.2.D. The source of the specimen;
14.2.b.2.E. The type of test performed;
14.2.b.2.F. The name, address, telephone and fax number of the submitting laboratory; and
14.2.b.2.G. The name, office address, office telephone and fax number of the physician or health care provider for whom the examination or test was performed.
14.2.b.3. Clinical laboratories that identify virological, serological, electron microscopic or molecular evidence of acute infection with LaCrosse, West Nile, Eastern Equine or St Louis encephalitis; orthopox virus (including smallpox and monkeypox); poliomyelitis; rabies; rubella; rubeola; or SARS coronavirus shall submit an acute specimen to the office of laboratory services for confirmation. In addition, the Commissioner may request routine submission of laboratory specimens for confirmation of other diseases by documentation of the request in the West Virginia Reportable Diseases Protocol Manual (available online at www.dide.wv.gov) and by written notification of laboratory directors. During an outbreak or other special investigations, the Commissioner may request submission of clinical specimens or isolates from persons with disease during a timeframe specified by the Commissioner.
14.2.b.4. In addition, the laboratory shall assist the Commissioner or local health officer in ruling out reported suspect cases of infectious diseases by submitting copies of negative laboratory tests for the condition under evaluation.
14.3. Administrators of schools, camps, vessels, correctional facilities, daycares and department-operated health care facilities.
14.3.a. The administrator or any responsible health care provider of any school, camp, vessel, correctional facility, daycare or department-operated health care facility shall:
14.3.a.1. Report any reportable disease, outbreak or condition occurring in the school, camp, vessel, correctional facility, daycare or department-operated health care facility as required by this rule;
14.3.a.2. Assist public health officials in appropriate case-finding for additional cases, including sharing information such as the name and contact information for persons who have signs and symptoms of illness;
14.3.a.3. Assist public health officials with appropriate case and outbreak investigation or management and in any necessary contact investigation and management, including sharing the name and contact information for persons who may have been exposed to an infectious disease;
14.3.a.4. Follow a method of control specified by the Commissioner in established protocols in the West Virginia Reportable Diseases Protocol Manual (available online at www.dide.wv.gov) or by recommendations developed in consultation with the Commissioner;
14.3.a.5. If the disease or condition is communicable, advise, in consultation with state and local public health officials, the patient, and as necessary, members of the patient's household and other patient contacts, including daycare staff and attendees, school staff and students and correctional staff and inmates regarding the precautions to be taken to prevent further spread of the disease. In cases of sexually transmitted diseases, HIV, and tuberculosis the Bureau recommends that the school, camp, vessel, correctional facility, daycare or department-operated health care facility refer contact notification activities to the STD/HIV/AIDS program and local health departments for tuberculosis rather than attempt to accomplish the notification themselves; and
14.3.a.6. Assist the local health officer by promoting implementation of the control method for the disease or condition specified in the protocol with the patient, and, as applicable, members of the patient's household, facility staff, and other involved individuals.
14.3.b. For schools, disclosure of personally identifiable information from the student’s education records to the Commissioner for investigation of a case or outbreak of communicable disease is classified as a Health and Safety Emergency under the federal Family Educational Rights and Privacy Act (FERPA) allowing for the release of information needed for protection of public health.
W. Va. Code R. § 64-7-15 Distribution of Rule
The Bureau and health care professional licensing boards and agencies may distribute this rule to licensed health care professionals who have a duty under this rule. Local health departments may copy and distribute this rule to local health care providers at no cost. The rule is also available online from the Secretary of State’s office at www.wvsos.com.
W. Va. Code R. § 64-7-16 Responsibilities of Local Health Officers
16.1. Local health officers shall comply with the requirements of this rule.
16.2. Local health officers shall annually notify health care providers, facilities and laboratories in their jurisdiction of the reporting requirements in this rule. Local health officers shall annually notify veterinarians, animal control officers, humane shelters and other persons of their responsibility for reporting animal bites and related potential rabies exposures under this rule.
16.3. Local health officers shall maintain a record of the information they collect and the reports they make pursuant to this rule according to the record retention schedule for the local health department. They shall give the information and reports to their successor.
16.4. Upon receipt of a reportable disease or condition report, a local health officer shall:
16.4.a. As circumstances require, investigate the source of the disease or condition, identify contacts, look for undetected and unreported cases, and implement the prevention and control methods specified by the protocols in the West Virginia Reportable Diseases Protocol Manual (available online at www.dide.wv.gov), or developed in consultation with the Commissioner;
16.4.b. Act in accordance with the protocols established by the Commissioner in the West Virginia Reportable Diseases Protocol Manual (available online at www.dide.wv.gov), or recommendations developed in consultation with the Commissioner;
16.4.c. Determine if required specimens have been collected and submitted; and if not, arrange for collection and submission of the necessary specimens to investigate the case, determine the source of the infection, and identify infection of contacts, as necessary. Local health officers shall submit specimens to the Bureau laboratory or other laboratory approved by the Commissioner;
16.4.d. Give the patient, those persons caring for the patient, household members, and other contacts instructions and advice necessary to prevent the spread of the disease or condition; and
16.4.e. Report any disease or condition listed in this rule to the Bureau within the time frame specified in each category.
16.5. If the report received is a death certificate listing a reportable disease or condition, the local health officer shall ascertain whether the disease or condition was reported according to the requirements of this rule prior to the individual's death. As with any other report, the local health officer shall investigate the source of the disease or condition, identify contacts, and look for undetected and unreported cases and implement prevention and control measures as circumstances require.
16.6. Whenever a local health officer knows of or suspects the existence of any reportable disease, outbreak or condition, and either no health care provider is in attendance, or the health care provider has failed or refused to comply with this rule, the local health officer shall investigate the alleged reportable disease, outbreak or condition. If the investigation establishes the existence of a reportable disease, outbreak or condition, the local health officer shall further investigate, manage, and report the disease or condition as required by this rule.
16.7. If the local health officer determines that a health care provider, health care facility, laboratory, or other individual named in this rule as responsible for reporting failed to report a reportable disease, outbreak or condition, the local health officer shall notify the responsible individual or facility and shall request an explanation for the failure to report the disease as required by this rule.
16.8. The local health officer shall report to the Commissioner the name and address of the health care provider, health care facility, laboratory, or other responsible individual named in this rule and his or her reason for failure to comply with the requirements of this rule.
W. Va. Code R. § 64-7-17 Management of Undiagnosed Diseases or Conditions Suggesting a Reportable Disease or Condition
When presenting symptoms of an undiagnosed disease or condition suggest a reportable disease, outbreak or condition, the local health officer may initiate and enforce control methods appropriate for the suggested reportable disease or condition until a definitive diagnosis is established. If the disease diagnosed does not require the control measures initiated, then these measures shall be terminated immediately.
W. Va. Code R. § 64-7-18 Disputed Diagnoses of Reportable Diseases or Conditions
When doubt exists as to the diagnosis of a submitted reportable disease or condition, the local health officer may enforce the protocol and methods of control established by the Commissioner for the suspected disease, outbreak or condition and shall simultaneously notify the Commissioner of the case. If the Commissioner judges it necessary, he or she shall consult or assist with any investigation needed to make a final decision.
W. Va. Code R. § 64-7-19 Designation of Diseases as Sexually Transmittable
As allowed under W. Va. Code §16-4-1 and for the purposes of treatment under W. Va. Code §16-4-10, the following diseases are designated as potentially sexually transmittable: chlamydia trachomatis, gonorrhea, herpes simplex virus type 2, syphilis (all stages), chancroid, lymphogranuloma venereum, human immunodeficiency virus, hepatitis B virus, and any other diseases the Commissioner determines sexually transmittable, by order filed with the Secretary of State. The Commissioner may, by order filed with the Secretary of State, also remove the designation of diseases he or she has, by order, previously designated.
W. Va. Code R. § 64-7-20 Confidentiality
20.1. Any epidemiologic information collected and maintained pursuant to this rule by local health officers or the Commissioner which identifies an individual or facility as having or suspected of having a reportable disease or condition, or as having been identified in an epidemiologic investigation is confidential and exempt from disclosure as provided in W. Va. Code §29B-1-1, et seq., the Freedom of Information Act. The same information is also confidential and exempt from disclosure pursuant to a subpoena, unless accompanied by a Court Order signed by a Judge.
20.2. In the case of an individual, the Commissioner or a local health officer may release confidential information identified in subsection 20.1. of this section to the following:
20.2.a. The patient;
20.2.b. The patient’s legal representative whose authority encompasses the authority to access the patient’s confidential information;
20.2.c. Individuals who maintain and operate the data and medical record systems used for the purposes of this rule, if the systems are protected from access by persons not otherwise authorized to receive the information;
20.2.d. The patient’s physician or other medical care provider when the request is for information concerning the patient’s medical records and is, in the determination of the Commissioner or the local health officer, to be used solely for the purpose of medical evaluation or treatment of the patient;
20.2.e. Any individual with the written consent of the patient and of all other individuals identified, if applicable, in the information requested;
20.2.f. Staff of a federal, State, or local health department or other agencies with the responsibility for the control and treatment of disease, to the extent necessary for the agency to enforce specific relevant provisions of federal, State and local law, rules and regulations concerning the control and treatment of disease;
20.2.g. Medical personnel caring for a potentially exposed individual to the extent necessary to protect the health or life of the exposed individual;
20.2.h. The manager or director of a licensed facility, restaurant, school or daycare where the case or suspected case resides, or is employed or in attendance, if determined absolutely necessary by the Commissioner for protection of the public’s health under the following provisions:
20.2.h.1. Disclosed information is limited to the name of the individual, the name of the disease, laboratory test results associated with the reportable disease and steps the manager or director shall take to assure protection of the health of the public; and
20.2.h.2. The personal identity of the employee shall be kept confidential by the manager or director to whom a disclosure was made; and
20.2.i. The persons to whom reports are required to be filed under W. Va. Code §49-6A-1, et seq., regarding children suspected to be abused or neglected is subject to the confidentiality protections of W. Va. Code §§16-4-10, 16-29-1 and 16-3C-3, or any other applicable confidentiality code section.
20.3. In the case of a licensed facility, the Commissioner or a local health officer may release confidential information to the public when there is a clear and convincing need to protect the public’s health as determined necessary by the Commissioner.
W. Va. Code R. § 64-7-21 Isolation, Quarantine and Placarding
21.1. The authority to implement and terminate quarantine or placarding to prevent spread of a communicable disease or to protect the public from other health hazards rests with the Commissioner. This authority extends to local health officers when they are following protocols established by the Commissioner for management of reportable diseases and conditions, or established following consultation with the Commissioner for these or other health risks.
21.2 When an individual or a group of individuals is suffering from a communicable disease for which isolation is required for the control of the disease, the local health officer may initiate and terminate the necessary isolation, unless the person is in a hospital, nursing home, or other institution. In these cases, the attending physician or other responsible health care provider within the institution shall assume responsibility for isolation and its termination.
21.3. No person shall interfere with or obstruct any local health officer in the posting of any placard used to prevent transmission of a communicable disease or exposure to another health hazard. In addition, no person shall conceal, mutilate or remove any placard, except by permission of the local health officer.
21.4. In the event a placard is concealed, mutilated or torn down, the occupant or, if there is no occupant, the owner of the premises where the placard was posted shall notify the local health officer of the fact immediately upon discovery.
W. Va. Code R. § 64-7-22 Exclusion from School Due to a Communicable Disease; Readmission
22.1. When a pupil or school personnel member suffers from a communicable disease potentially placing other students or school personnel at risk of disease, the individual may be excluded from school by the local health officer, the individual’s physician, or the school administrator acting in accordance with the Department of Education rule, “Communicable Disease Control Policy”, 126CSR51.
22.2. When a pupil or school personnel member has been excluded from school due to a communicable disease, the individual may return upon presentation of a certificate of health to school officials from a physician, local health officer or his or her authorized representative stating that the individual is no longer liable to transmit the disease to others. The return is subject to compliance with the Department of Education rule, “Communicable Disease Control Policy”, 126CSR51.
W. Va. Code R. § 64-7-23 Examination and Training of Food Service Workers
23.1. Food service management training or workers' training may be provided by the local health departments at the discretion of the local health officer.
23.2. Food service management training courses shall satisfy the local health officer that the training of management personnel will result in suitable training for the other food service workers within that particular food service establishment.
23.3. For the protection of the public, the local health officer may advise a medical examination of a food service worker by a physician approved by the local health officer. In addition, the local health officer may exclude the individual from specific work activities until the exam is completed and the individual no longer presents a threat to public health.
23.4. The local health officer may require any laboratory examinations necessary to detect any condition in the food service worker or in the food service facility in which the worker is working, whether or not for compensation, which might constitute a hazard to the public's health.
W. Va. Code R. § 64-7-24 Penalties
24.1. Any person who is subject to the provisions of this rule who fails to report a disease or condition as required by this rule or otherwise fails to act in accordance with this rule is guilty of a misdemeanor, and, upon conviction thereof, shall be fined not more than five hundred dollars ($500), as provided under W. Va. Code §16-1-18. Each violation is considered a separate offense.
24.2. Any local health officer who fails or neglects to appropriately investigate cases or suspected cases of reportable diseases or other public health threats reported to him or her by any physician, health care provider or other person, within a reasonable period of time after the receipt of the report, is guilty of neglect of duty and may, at the discretion of the Commissioner, be removed from office in accordance with W. Va. Code §§16-2-4 or 16-2A-8.
24.3. A local health officer who fails to make the immediate or weekly reports required by this rule in the manner specified by the Commissioner is guilty of neglect of duty and may at the discretion of the Commissioner, be removed from his or her office according to the provisions of W. Va. Code §16-2-12.
W. Va. Code R. § 64-7-25 Administrative Due Process
Those persons adversely affected by the enforcement of this rule desiring a contested case hearing to determine any rights, duties, interests or privileges shall do so in a manner prescribed in the Bureau procedural rule, Rules of Procedure for Contested Case Hearings and Declaratory Rulings, 64CSR1.
Series 09 Sewage Systems
W. Va. Code R. § 64-9-1 General
1.1. Scope. -- This legislative rule establishes minimum requirements for sewer systems, sewage treatment or disposal plants which serve public sewer systems, and the certification of sewage tank installers.
1.2. Authority. -- W. Va. Code '16-1-7.
1.3. Filing Date. -- March 30, 1998.
1.4. Effective Date. -- May 1, 1998.
1.5. This rule amends, retitles and reenacts Sewage System Rules, 64 CSR 9, effective May 12, 1983.
1.6. Application. -- This rule applies to all sewer systems in West Virginia; to sewage treatment or disposal plants which serve public sewer systems; and persons who engage in the business of installing, collecting, removing, transporting, or disposing of the contents of sewage tanks.
1.7. Enforcement. -- This rule is enforced by the director of the West Virginia division of health.
W. Va. Code R. § 64-9-2 Definitions
2.1. Acceptable Application. -- Completed forms, plans, specifications, fee, if required, and other data as specified by Sewage Treatment and Collection System Design Standards, 64 CSR 47.
2.2. Accessible. -- Sewers are considered accessible when a public sewer system is located adjacent to, or available by right-of-way, to a particular lot, and sewage can discharge thereto by gravity.
2.3. Approved. -- A procedure of operation or construction which is in accordance with design standards, specifications and instructions promulgated by the division of health.
2.4. Chief, Office of Water Resources. -- The chief of the office of water resources of the division of environmental protection.
2.5. Design Standards. -- Application procedures, design requirements, specifications and construction standards promulgated by the division of health.
2.6. Director. -- Director of the West Virginia division of health or his or her lawful designee.
2.7. Dwelling. -- A building, structure or place used or intended to be used for human occupancy as a single family or multi-family residence. The term "dwelling" includes, but is not limited to: house, housing, mobile homes, vacation homes and cabins.
2.8. Effluent. -- Liquid discharge from a sewage treatment or disposal system.
2.9. Establishment. -- Any building, structure or place used or intended to be used for multiple dwelling units, or for manufacturing, commercial, religious, institutional, educational or recreational purposes.
2.10. Individual Sewer System. -- A sewer system with a daily design flow not to exceed one thousand (1,000) gallons per day with subsurface discharge or not to exceed six hundred (600) gallons per day design flow with surface discharge. The system is owned by and maintenance is performed by a single entity.
2.11. Individual Sewer System Installer. -- Any person engaging in the construction, installation, modification, extension, alteration and location of an individual or an on-site sewer system, sewage tank, or an excreta disposal system.
2.12. Lot. -- A tract or parcel of land or part of a subdivision used as or intended to be used as a site for a dwelling or establishment.
2.13. Municipal Sewer System. -- A sewer system or a group of sewer systems which, as a whole, receives sewage from more than one (1) dwelling or establishment and is operated and maintained by an incorporated municipality, or public service district, or sanitary board.
2.14. Percolation Test. -- A method described in Sewage Treatment and Collection System Design Standards, 64 CSR 47, by which the soils in a particular area are evaluated for subsurface effluent disposal.
2.15. Permit. -- A written document issued by the director giving the holder permission to construct, install, extend, alter or operate an approved sewer system, or method of sewage disposal, or to collect, remove, transport or dispose of sewage.
2.16. Person. -- Individual, partnership, association, syndicate, company, firm, trust, corporation, government corporation, institution, department, division, bureau, agency, or any entity recognized by law.
2.17. Public Sewer System. -- A sewage collection system or systems with or without treatment facilities with a daily design flow exceeding one thousand (1,000) gallons per day with sub-surface discharge or exceeding six hundred (600) gallons per day with surface discharge serving one (1) or more dwellings or establishments. The system is owned by and maintenance is performed by a single entity. This definition includes municipal sewer systems.
2.18. Rock Strata -- A formation of indurated (hardened) material either above or below the ground surface that requires drilling, blasting or other methods of brute force for excavation.
2.19. Sewage. -- Any excreta or liquid waste containing animal or vegetable matter in suspension or solution including, but not limited to, waste from commodes, urinals, lavatories, bathtubs, laundry tubs, washing machines, drinking fountains, sinks, kitchen equipment, and other sanitary fixtures or facilities.
2.20. Sewer System. -- A sewer system, whether publicly or privately owned, which receives and treats sewage and provides for the disposal of effluent and sludge therefrom. This definition includes individual sewer systems and public sewer systems.
2.21. Sewage Tank. -- A water-tight receptacle designed and constructed to receive and retain sewage solids. Sewage tanks include, but are not limited to, septic tanks, aeration type sewage treatment systems, privy vaults, holding tanks or receptacles and self-contained excreta disposal facilities.
2.22. Sewage Tank Cleaner. -- Any person engaged in the collection, removal, transportation or disposal of sewage.
2.23. Standard Soil Absorption System -- A system designed to receive effluent from a septic tank to be disposed of at soil depths ranging from eighteen (18) to thirty-six (36) inches from the original ground surface.
2.24. Subdivision. -- A tract of land which has been divided into two (2) or more lots, tracts, parcels, plats, sites, areas, units, interests or other division for the purpose of dwelling or establishment development and including the division of land by deed, metes and bounds description, lease, map, plat or other instrument, or by act of construction.
2.25. Wastewater. -- Water containing human, animal, or domestic waste.
2.26. Water Well. -- Any excavation or penetration in the ground, whether drilled, bored, cored, driven or jetted that enters or passes through an aquifer for purposes that may include, but are not limited to: a water supply, exploration for water, dewatering or heat pump wells, except that this definition shall not include ground water monitoring activities and all activities for the exploration, development, production, storage, and recovery of coal, oil, and gas, and other mineral resources which are regulated under W. Va. Code ''22-1-1 et seq., 22A-1-1 et seq., or 22B-1-1 et seq..
W. Va. Code R. § 64-9-3 General Requirements
3.1. The owner or his or her authorized agent shall obtain a permit for a sewer system prior to the construction or installation of any dwelling or establishment which will require a sewer system. Where subsurface discharge systems are used, there shall be sufficient area to install the initial system and a suitable replacement area.
3.2. Every dwelling or establishment whether publicly or privately owned, where persons reside, assemble, or are employed, shall be provided with toilet facilities, and a sewer system approved by the director.
3.3. It is the duty of the owner of the dwelling or establishment to provide toilet facilities and a sewer system approved by the director.
3.4. When, upon investigation, the director finds a person is constructing, installing, extending, altering, maintaining or operating a toilet facility or sewer system which does not comply with applicable provisions of this rule, the person shall be notified of the fact in writing, and if said person shall fail to abate or correct the condition within a period of time not to exceed thirty (30) days after the receipt of the written notice, said person shall be guilty of a misdemeanor and, upon conviction thereof, shall be punished according to the penalty set forth.
3.5. All sewer systems shall be designed, constructed, installed, maintained and operated in such a manner that excreta or sewage contained therein or effluent discharged therefrom:
3.5.a. Not create a health hazard affecting the public; and
3.5.b. Shall not violate any federal, state or local laws, rules or regulations governing water pollution or sewage disposal.
3.6. The owner or operator of a sewer system to be abandoned shall abandon the system in the following manner:
3.6.a. The contents of the sewage tank shall be removed by a certified septic tank cleaner. The tank or excavation shall be filled to eliminate any physical hazard. If the tank is removed it shall be disposed of in a manner approved by the director. Sewage treatment lagoons (ponds) shall be abandoned in a manner approved by the director and the chief, office of water resources;
3.6.b. Any electrical service to the system shall be terminated, and electrical service boxes, switches, meters, and similar equipment, removed or rendered harmless;
3.6.c. Any water service to the system shall be disconnected; and
3.6.d. Any other potentially hazardous equipment associated with the system shall be removed or rendered harmless.
3.7. The owner and any person or persons installing or modifying a sewer system shall be jointly responsible for compliance with all applicable provisions of this rule.
3.8. Off-lot disposal of sewage or effluent requiring the use of or crossing of adjacent property shall require a recorded easement or authorization. This recorded document shall be binding to the heirs and assigns of the properties involved.
W. Va. Code R. § 64-9-4 Permits
4.1. In accordance with W. Va. Code '16-1-9, no sewer system shall be installed or established without first obtaining a written permit from the director.
4.2. Individual and public sewer systems shall be permitted and constructed only after an acceptable application for, and plans and specifications of, the proposed system, as prepared in accordance with Sewage Treatment and Collection System Design Standards, 64 CSR 47, have been reviewed and approved by the director. Where applicable, a discharge permit shall be obtained from the chief of the office of water resources in conformance with W. Va. Code '22-11-1 et seq. prior to construction.
4.3. An acceptable application to construct, install or modify an individual sewer system or a public sewer system shall be made in writing to the director. A permit to construct, install or modify shall be obtained prior to the construction or installation.
4.4. The director shall approve or deny any application for a permit to construct a public sewer system within a period of forty-five (45) working days from the date an application is received. The director shall approve or deny an application for an individual sewer system within a period of twenty-one (2l) working days from the date an application is received.
4.5. The director shall deny a permit if the information on the application form is incomplete, inaccurate, false, or misleading, or indicates the applicable provisions of this rule cannot be met.
4.6. A permit shall be suspended or revoked by the director for failure to comply with the provisions of the permit, improper construction or operation of the sewer system, where false or misleading information was utilized in obtaining the permit, where it is determined that the applicable provisions of this rule cannot be met, or for failure to comply with a lawful order of the director.
4.7. Any person whose application for a permit has been denied or whose permit has been suspended or revoked may request a hearing. A written request shall be made within thirty (30) days of the date of denial of the permit by the aggrieved party and a hearing date shall be established by the director within twenty (20) days of the director's receipt of the written request. The hearing shall be held by the director within a period of forty-five (45) days after receipt of the written request for the hearing.
4.8. A permittee who wishes to dispute the conditions and restrictions of the permit may request a hearing in order to appeal its provisions. A written request shall be made by the permittee within thirty (30) days of the date of issuance of the permit and a hearing date shall be established within twenty (20) days of the director's receipt of the written request. The hearing shall be held within a period of forty-five (45) days by the director after receipt of the written request for the hearing.
4.9. A permit for an individual sewer system or for a public sewer system on which construction has not begun within one (1) year from the date of issuance is invalid unless a request for a renewal is approved by the director.
4.10. Permits are not transferable or assignable and automatically become invalid upon a change in ownership, except when application for transfer or assignment is made to, and the transfer or assignment is approved by, the director. Permits shall be issued to the property owner.
4.11. A person engaging in the business of sewage tank cleaning shall receive a permit only after application has been made on a form prescribed by the director and the director has inspected, all sewage tank cleaning equipment, containers, or other devices used in the collection, removal, transportation or disposal of sewage tank contents to ascertain that the items are used, maintained and operated in compliance with all applicable provisions of this rule. The application shall include documentation that a disposal site approved by the department of environmental protection will be used for disposal of the sewage. A sewage tank cleaning permit shall expire one (1) year from the date of issuance, and the permit holder shall apply to the director for renewal of the permit prior to the expiration date. Notwithstanding any provision of the W. Va. Division of Health Legislative Rule, Fees for Permits, 64 CSR 30, any fee for authorizing an individual to engage in the business of sewage tank cleaning shall be prorated over a three-year period at $16 (sixteen dollars) per year.
4.12. When a sewage tank cleaning permit has been suspended or revoked, the person thereby affected shall immediately discontinue engaging in the business of collecting, "removing," transporting or disposing of the contents of sewage tanks.
W. Va. Code R. § 64-9-5 Construction and Installation Requirements
5.1. The construction and installation or modification of all sewer systems shall be in accordance with Sewage Treatment and Collection System Design Standards, 64 CSR 47, or otherwise approved plans and specifications for which a permit has been issued by the director. Design standards may be obtained from the division of health, its district offices or local health department offices: Provided, that the director shall issue a permit for the installation of a National Sanitation Foundation Class I home aeration unit to be installed on a single family dwelling unit when no other approved system can be installed.
5.2. Diversion drains, ditches and curtain drains shall be installed when storm water, surface or ground water will affect the satisfactory operation of a sewer system. No foundation drains or downspouts shall be connected to the sewer system.
5.3. Percolation tests and other tests, as may be required for installation of a sewer system, shall be performed by persons whose qualifications are acceptable to the director and the tests shall be conducted in accordance with Sewage Treatment and Collection System Design Standards, 64 CSR 47. The person conducting the tests shall certify the accuracy of the results of the tests and the information shall be submitted in a form acceptable to the director.
5.4. Subsurface absorption systems shall be constructed at the site where percolation and other tests have been performed. In the event the location of the subsurface absorption system must be changed, additional testing will be required at the proposed new location.
W. Va. Code R. § 64-9-6 Inspections
6.1. The director may make, as many inspections as are necessary during the construction, installation, modification, or operation of sewer systems to determine compliance with the applicable provisions of this rule.
6.2. The owner or occupant of a dwelling, establishment, or land where a sewer system is located shall provide the director access to all parts of the property for the purpose of making the inspection.
6.3. No sewer system shall be used or placed into operation until the system installation has been approved in writing by the director.
6.4. No part of any sewer system utilizing soil absorption disposal of effluent shall be covered until the system installation has been approved in writing by the director. Any part of the system that is covered prior to approval shall be uncovered upon oral or written order of the director.
6.5. In addition to making inspections or causing inspections to be made of a sewer system, the director may collect or cause to be collected samples of sewage and effluent from the system, or conduct or cause to be conducted, such tests as are necessary and proper to insure that the system is in compliance with all applicable provisions of this rule.
6.6. If the director finds that the construction, installation, extension, alteration, or operation of a sewer system is not in compliance with the applicable requirements of this rule, the director may issue an order for the corrections to be made. The order shall be issued in writing to the owner of the sewer system and the order shall be effective immediately.
W. Va. Code R. § 64-9-7 Maintenance and Operation of Sewer Systems, and Sewage Treatment or Sewage Disposal Systems
7.1. Upon written request by the director, the permit holder shall submit operational data such as influent, effluent, flow data, or any operational data necessary to ascertain compliance with this rule.
7.2. All mechanical sewer systems with surface discharge and all mechanical sewer systems where additional treatment is required for subsurface discharge shall have a perpetual maintenance program approved by the director.
7.3. Every sewage treatment or disposal plant serving a public sewer system shall be equipped with testing apparatus for making the physical, chemical, and bacteriological control tests which are considered necessary by the state division of health for the safe, proper, and efficient operation of the plant. The state division of health, upon written request, shall furnish a statement of the control tests necessary for a particular plant.
7.4. There shall be regularly made at each sewage treatment or disposal plant any physical, chemical, and bacteriological control tests which are considered necessary by the state division of health for the proper and safe operation of the plant. The frequency of making these physical, chemical, and bacteriological control tests shall be determined by the state division of health. The results of the control tests together with the record of sewage treatment or disposal plant operation shall be entered upon a permanent record form or ledger and maintained at the plant.
7.5. Each month, or as otherwise directed by the state division of health, the operator of the sewage treatment or disposal plant shall furnish a summary of operation and control data to the state division of health. The data shall be submitted on a standard form or another form acceptable to the state division of health.
7.6. The division of health, by specific written direction, may waive the submission of operating reports from sewage treatment or disposal plants serving five hundred (500) or less persons.
W. Va. Code R. § 64-9-8 Subdivisions
8.1. All subdivisions or housing developments originating after July 1, 1970, the effective date of the original regulations, shall be served by a method of sewage disposal approved by the director.
8.2. In the event individual sewer systems are proposed as the desired method of sewage disposal for a subdivision, the property owner shall obtain written approval from the director in compliance with the provisions of this rule;
W. Va. Code '16-1-7 and the procedures set forth in Sewage Treatment and Collection System Design Standards, 64 CSR 47. In addition, a permit for each individual sewer system within the subdivision shall be obtained in compliance with Section 4 of this rule.
8.3. The replatting of a prior recorded plat or of a subdivision which originated prior to July 1, 1970 is not exempt from the provisions of this rule. The prior platting of a portion of a larger tract prior to July 1, 1970, does not exempt the remainder of the tract from the provisions of this rule.
8.4. The division of land through public or private auction sale or through the terms of a will or court order constitutes a subdivision under the provisions of this rule. It is the responsibility of the owner of the land or the executor of the will to meet all requirements of this rule.
8.5. In instances where a lot was purchased or acquired for dwelling construction, and either its deed was recorded prior to July 1, 1970, or the lot was laid out, described and designated on a map of a subdivision, which map was recorded prior to July 1, 1970 and where a public water supply system is available, but a public sewer system is not available, no individual sewer system is permissible on any lot, site or area containing less than ten thousand (10,000) square feet.
8.6. In instances where a lot was purchased or acquired for dwelling construction, and, either its deed was recorded prior to July 1, 1970 or the lot was laid out, described and designated on a map of a subdivision, which map was recorded prior to July 1, 1970 and where neither a public sewer system nor a public water supply system is available, no individual sewer system is permissible on any lot, site or area containing less than twenty thousand (20,000) square feet.
8.7. The director may waive the square footage requirements stipulated in Subsections 8.5 or 8.6 of this rule if he or she has been petitioned and has ascertained through a hearing, an on-site inspection, percolation tests and other requirements of this rule that an individual sewer system can be expected to function satisfactorily on a lot, site, or area containing less than the minimum prescribed number of square feet.
8.8. All lots originating prior to May 12, 1983, where individual sewer systems are proposed, shall comply with Subsection 3.1 of this rule.
8.9. Where the use of on-site soil absorption systems is proposed, the procedures and requirements of Subdivisions 8.9.a through 8.9.g of this rule apply. The owner of the subdivision shall obtain written approval for the proposed subdivision from the division of health prior to initiation of construction.
8.9.a. All lots less than two (2) acres in total surface area or lots with an average frontage of less than one hundred and fifty (150) feet) shall contain a minimum on-site disposal area of ten thousand (10,000) square feet, which shall be set aside for the installation of standard soil absorption system(s). No development or structures are permissible on this on-site disposal area other than those comprising the individual sewer system(s). The layout of each reserve area shall be such that ten thousand (10,000) square feet is usable for the installation of standard soil absorption system(s). Where multiple reserve areas are used, each shall be three thousand (3,000) square feet or more in size.
8.9.b. Area consisting of land sloping in excess of twenty-five percent (25%), or land in an existing or proposed public road may not be utilized in establishing the minimum area for lots in accordance with the requirements of Subsection 8.9.a of this rule.
8.9.c. Area consisting of land containing rock strata or seasonal high water table within five (5) feet of the ground surface may not be utilized in establishing the minimum area for lots in accordance with the requirements of Subsection 8.9.a of this rule. Area consisting of land not in compliance with the minimum separation distances listed in Sewage Treatment and Collection System Design Standards, 64 CSR 47, may not be utilized in establishing the minimum area for lots in accordance with the requirements of Subsection 8.9.a of this rule.
8.9.d. Area consisting of land which has been determined through testing to have a percolation rate slower than ninety (90) minutes per inch shall not be utilized in establishing the minimum area for lots in accordance with the requirements of Subsection 8.9.a of this rule.
8.9.e. Area where routine seasonal flooding occurs may not be utilized in establishing the minimum area for lots in accordance with the requirements of Subsection 8.9.a of this rule unless approved by the director.
8.9.f. All lots two (2) acres and over shall contain a minimum on-site disposal area of ten thousand (10,000) square feet, which shall be set aside for the installation of standard or alternative soil absorption system(s). No development or structures are permissible on this on-site disposal area other than those comprising the individual sewer system(s). The layout of each reserve area shall be such that ten thousand (10,000) square feet is usable for the installation of standard or alternative soil absorption system(s). Where multiple reserve areas are used, such areas shall be three thousand (3,000) square feet or more in size.
8.9.g. Alternative systems which may be considered for new construction on lots two (2) acres and over include low pressure systems, mound systems, shallow and elevated soil absorption systems, experimental systems, and unique systems designed for specific situations.
W. Va. Code R. § 64-9-9 Correction of Health Hazards
9.1. To correct or abate public health hazards resulting from the malfunctioning of individual sewer systems, and public sewer systems which hazards are not correctable by methods set forth in Sewage Treatment and Collection System Design Standards, 64 CSR 47, the director may permit the installation of an experimental or nonstandard sewer system upon written petition for the system.
9.2. The petition shall request the director to authorize installation of the system desired and shall contain information as to the location, reasons why a conventional system cannot be installed, information concerning the malfunctioning system, and information concerning the system desired. The director may request additional information which may include a meeting with the petitioner.
9.3. If the director determines that a potential public health hazard exists, he or she may issue a written approval authorizing installation of the system desired. The written approval shall apply only to the petitioner and the facts presented at the meeting.
W. Va. Code R. § 64-9-10 Sewage Tank Cleaning
10.1. No person shall engage in the business of collecting, removing, transporting, or disposing of the contents of a sewage tank without first obtaining in the county in which the business is located a state-wide permit for the activity from the director, in accordance with Section 6 of this rule. Out of state sewage tank cleaners shall obtain the permit from the county where most of their business is located.
10.2. Equipment, containers or other devices used in the collection, removal, transportation or disposal of the contents of sewage tanks shall be in compliance with Sewage Treatment and Collection System Design Standards, 64 CSR 47.
10.3. The cleaning of sewage tanks by bailing or dipping and emptying the bailing or dipping container into a carrier tank is prohibited.
10.4. Precaution shall be taken by the sewage tank cleaner to prevent the leaking, spilling, or dripping of the sewage tank contents during collection, removal, transportation and disposal.
10.4.a. Any leakage, spillage, or drippings shall be cleaned up immediately.
10.4.b. Provisions shall be made by the sewage tank cleaner to carry chlorinated lime or similar satisfactory disinfectant for immediately treating the areas where leakage, spillage, or dripping has occurred.
10.5. The contents of sewage tanks shall not be transported in an open bed motor carrier vehicle, or any other type vehicle, unless said sewage contents are contained within approved portable receptacles.
10.6. All facilities used for the cleaning of sewage tank cleaning equipment shall, prior to use, be inspected and approved by the director.
10.7. The contents of sewage tanks shall be disposed of in a manner that will prevent the spread of disease and avoid nuisance conditions, and said contents shall be disposed of in accordance with Sewage Treatment and Collection System Design Standards, 64 CSR 47.
10.8. Special written permission from the director shall be obtained for any method of cleaning or disposal not specifically mentioned in Sewage Treatment and Collection System Design Standards, 64 CSR 47.
10.9. All sewage tank cleaners shall keep a written record of all jobs accomplished. The record shall be on a form prescribed by the director and submitted to the director quarterly.
W. Va. Code R. § 64-9-11 Individual Sewer Systems Installers Certification
11.1. Except as provided in Subsection 11.2 of this rule, all individual or on-site sewer system installers shall be certified by the director. An individual shall be a minimum of eighteen (18) years old to qualify for certification.
11.2. The director may grant a permit to an individual who installs, constructs, extends, alters his or her own sewer system if the individual passes an examination administered by the director which demonstrates knowledge of applicable rules.
11.3. Certification is not required of a driver delivering a part or parts of a system, a manufacturer who does not install a part or parts of a system or an employee of a contractor holding a certificate, provided, that the employee is under the direct on-site surveillance of a certified installer.
11.4. Certificates shall be issued to qualified installers of individual sewer systems in two classifications:
11.4.a. A class I certificate applies to the installation of standard soil absorption systems, soil absorption beds, holding tanks, effluent lift stations and grey water soil absorption systems.
11.4.b. A class II certificate applies to those systems covered by the class I certificate plus all alternative and other individual or on-site sewer systems as set forth in Sewage Treatment and Collection System Design Standards, 64 CSR 47.
11.5. An application for certification as an individual sewer system installer, or renewal of certification as an individual sewer system installer, shall be made in writing to the director on a form prescribed by the director.
11.6. The director may deny certification if the information on the application form is incomplete, inaccurate, false or misleading.
11.7. In addition to filing an application for certification as an individual sewer system installer, the applicant shall pass a written examination for each classification and shall be required to demonstrate that he or she possesses adequate knowledge and skill in making installations in accordance with Sewage Treatment and Collection System Design Standards, 64 CSR 47.
11.8. Written examinations shall be administered by the director at a site and on a date designated by the director. An applicant shall attain a passing grade of seventy percent (70%) to qualify for certification. Any applicant who has failed an examination shall wait thirty (30) days before re-examination.
11.9. Certification is not transferable or assignable and becomes invalid upon suspension or revocation.
11.10. Certification expires five (5) years from date of issuance and the certificate holder shall apply to the director for renewal of the certificate prior to the expiration date. Should the expiration date be exceeded by six (6) months, renewal cannot be issued. Renewal shall be based upon recommendation of the local health department in those counties knowledgeable of the individual=s work.
11.11. In the event any person certified is found to be violating any of the applicable requirements of this rule, his or her certification may be immediately suspended for a period of thirty (30) days by the director. Two separate violations shall be sufficient grounds for revocation of certification.
W. Va. Code R. § 64-9-12 Sewage Advisory Board
12.1. The director may establish an advisory board and designate the chairman of the board.
12.2. The advisory board membership shall consist of, but is not necessarily be limited to, the following members: two (2) representatives of the sewage industry; two (2) representatives of the division of health; one (1) representative of the division of environmental protection; and four (4) representatives of local health departments.
12.3. The duties of the advisory board shall be assigned by the director.
W. Va. Code R. § 64-9-13 Penalties
13.1. Any person who violates any provision of this rule is subject to the penalties provided in W. Va. Code '16-1-18.
13.2. Each day's failure to comply with any applicable provision of this rule constitutes a separate offense.
W. Va. Code R. § 64-9-14 Administrative Due Process
Those persons adversely affected by the enforcement of this rule desiring a contested case hearing to determine any rights, duties, interests or privileges shall do so in a manner prescribed in this rule and in the Rules of Procedure for Contested Case Hearings and Declaratory Rulings, 64 CSR 1.
The Department of Health and Human Resources (DHHR) was created by the Legislature's reorganization of the executive branch of State government in 1989. The Department of Health was renamed the Division of Health and made a part of the DHHR (W. Va. Code ' 5F-1-1 et seq.). Administratively within the DHHR the Bureau for Public Health through its Commissioner carries out the public health function of the Division of Health.
64CSR9
Series 10 Methods and Standards for Chemical Tests for Intoxication
W. Va. Code R. § 64-10-1 General
1.1. Scope. -- This legislative rule establishes the methods and standards relating to implied consent for chemical test for intoxication pursuant to appropriate articles of Chapter 17C of the West Virginia Code.
1.2. Authority. -- W. Va. Code §16-1-4 and §17C-5-8.
1.3. Filing Date. -- April 1, 2022.
1.4. Effective Date. -- April 1, 2022.
1.5. Sunset Provision. -- This rule shall terminate and have no further force or effect upon August 1, 2027.
W. Va. Code R. § 64-10-2 Application and Enforcement
2.1. Application. The provisions of this rule are applicable to all law enforcement agencies and personnel engaging in breath, blood, urine, alcohol and/or drug analysis in this state; and to those persons suspected of driving under the influence of alcohol or drugs, or both.
W. Va. Code R. § 64-10-3 Definitions
3.1. Agency means a law enforcement agency in the state engaging in breath, blood, and/or urine alcohol testing.
3.2. Alcohol means ethyl alcohol and may include methyl alcohol and isopropyl alcohol.
3.3. Alcohol breath analysis means chemical testing of a sample of a person's expired breath, using a breath test instrument designed for that purpose, in order to determine the concentration of alcohol in the person's blood.
3.4 Alveolar composition means deep lung air or end-expiratory breath.
3.5 Bureau means the West Virginia Bureau for Public Health.
3.6 Calibrating unit means a device designed to produce a predictable alcohol concentration reading on a breath alcohol test instrument.
3.7 Certified instrument operator means a person who has successfully completed a specialized training program and has been certified by the Bureau to perform breath alcohol testing using instruments approved for that purpose.
3.8 Chemical Test or Testing means an analysis performed on a biological material, including, but not limited to breath, blood, or urine, to determine the identity or concentration, or both, of particular constituents such as alcohol or controlled substances. Test procedures may rely on one or more physical or chemical properties of the constituents and use instrumental or chemical analysis techniques to accomplish the determination.
3.9 Commissioner means the commissioner of the West Virginia Bureau for Public Health or his or her lawful designee.
3.10 Dry gas standard means a sealed pressurized sample of gas that contains a predictable alcohol concentration that can be used to verify the accuracy of breath test instruments.
3.11 Evidential test sequence means one adequate blank analysis, one adequate reference standard analysis, one adequate blank analysis, one adequate breath sample analysis, one adequate blank analysis, a second adequate reference standard analysis, and one adequate blank analysis.
3.12 Instrument means an item or combination of items of equipment designed to make a measurement of alcohol concentration.
3.13 Instrument blank analysis means a test of an ambient air sample to ensure that the instrument produces a zero result.
3.14 Lot means an entire quantity batch of a reference standard.
3.15 Qualitative breath alcohol analysis means a test of a person’s breath, the results of which indicate the presence or absence of alcohol.
3.16 Quantitative breath alcohol analysis means a chemical test of a person’s breath that yields a specific result in grams of alcohol per 210 liters of breath.
3.17 Reference standard means an aqueous ethanol solution compounded for use in a calibrating unit which, when equilibrated with air yields a predictable alcohol concentration or a sealed pressurized sample of gas that contains a predictable alcohol concentration that can be used to inspect or verify the accuracy of breath test instruments.
3.18 Secondary breath analysis means an evidentiary chemical test of a person’s breath to determine the presence and/or concentration of alcohol.
3.19 Simulator Solution means an aqueous standard ethanol solution which, when equilibrated with air in a breath simulator instrument produces an air-alcohol mixture of a predictable concentration (i.e., 0.02-0.20 grams W/V) that can be used to inspect or verify the accuracy of breath test instruments.
3.20 Simulator Test means the testing of a sample of simulator solution vapor, using a breath test instrument in order to verify the accuracy of the breath test instrument.
3.21 W/V means weight divided by volume.
W. Va. Code R. § 64-10-4 Preliminary Breath Analysis; Designation of Testing Instrument; Compliance with Methods and Standards Required
4.1. Each law enforcement agency using a preliminary breath testing instrument shall designate the testing instrument for the purpose of administering a preliminary breath analysis pursuant to W. Va. Code §17C-5-5. The designation of the testing instrument shall be filed with the Bureau on a form provided by the Bureau available at https://dhhr.wv.gov/ols/regulatory/Documents/Designation%20of%20Instrument% 20Device%20for%20Preliminary%20Testing%2064-10.pdf.
4.2. Each law enforcement agency shall comply with the methods and the standards established by this rule.
4.3. The Bureau shall maintain a registry of approved testing instruments.
4.4. All instruments used for the purpose of preliminary alcohol breath analysis shall be approved in writing by the Commissioner.
4.5. Approvals and designations of preliminary breath testing instruments in effect at the time this rule becomes effective continue in effect.
W. Va. Code R. § 64-10-5 Breath Analysis; Preliminary Breath Test; Standards and Methods
5.1. The use of the approved instrument shall adhere to the manufacturer's specifications for operation and shall include any maintenance specified by the manufacturer.
5.2. The following general methods apply in extracting breath for preliminary breath analysis:
5.2.1. The preliminary alcohol breath analysis shall be administered after the law enforcement officer has a reasonable belief that the person has been driving while under the influence of alcohol. The law enforcement officer shall prohibit the person from drinking alcohol or smoking for at least fifteen minutes before conducting the test.
5.2.2. If the testing instrument requires contact with the mouth of the tested person, the law enforcement officer conducting the preliminary alcohol breath analysis shall use an individual disposable mouthpiece for each person tested.
5.2.3. The preliminary alcohol breath analysis may be administered by a law enforcement officer who is a certified instrument officer and who has additional training, theory, and practical exercise recommended by the manufacturer.
5.3. The results of a preliminary alcohol breath analysis shall be used for the purpose of guiding the officer in deciding whether an arrest should be made and to determine if alcohol is a contributing cause for impairment.
W. Va. Code R. § 64-10-6 Designation of Secondary Test; Compliance with Methods and Standards Required; Certification of Law Enforcement Officers Required
6.1. Each law enforcement agency shall designate a type of test, either breath or blood or urine for the purpose of administering a secondary alcohol breath analysis incidental to lawful arrest for the offense of driving a motor vehicle in this state while under the influence of alcohol. The designation of the alcohol breath analysis shall be filed with the Bureau on a form provided by the Bureau available at https://dhhr.wv.gov/ols/regulatory/Documents/Designation%20of%20Instrument%20Device%20for%20Secondary%20Testing%2064-10.pdf.
6.2. Each law enforcement agency shall comply with the methods and the standards established by this rule.
6.3. The Bureau shall maintain a registry of approved alcohol breath analysis instruments inclusive of methods and standards for the proper conduct of the alcohol breath analysis.
6.4. Secondary alcohol breath analysis designations in effect at the time this rule becomes effective shall continue in effect.
6.5. Each law enforcement officer administering a secondary alcohol breath analysis shall be a certified instrument operator.
6.6. The Bureau shall certify each operator properly trained in the procedures of operation and shall issue a certificate to each trained individual.
6.7. As a minimum training requirement each law enforcement officer shall complete the Basic Training Program for Breath Examiner Specialist Course as prescribed by the United States Department of Transportation or an equivalent course prior to certification. This course shall consist of classroom and laboratory training including review sessions and examinations.
6.8 Certifications of law enforcement officers in effect at the time this rule becomes effective continue in effect.
W. Va. Code R. § 64-10-7 Breath Analysis; Secondary Breath Test; Standards; Accuracy Inspection Tests; Methods
7.1. Instrument Standards - Instruments for breath alcohol analysis shall meet the following standards:
7.1.1. The designated instrument and any related accessories shall be capable of the collection and the analysis of breath specimens which approach alveolar composition;
7.1.2. The designated instrument shall be capable of analyzing a blank sample and of analyzing a suitable reference standard;
7.1.3. The designated instrument shall be capable of the analysis of a reference standard within accuracy and precision limits of plus or minus 0.01 grams percent W/V or higher;
7.1.4. The designated instrument shall be capable, in a controlled experiment, of alcohol breath analysis which results in a determination of a person's blood alcohol concentration which has a correlation with his or her actual blood alcohol concentration as measured on a blood sample taken at approximately the same time as the breath sample;
7.1.5. The instrument shall be capable of alcohol breath analysis which results in a concentration less than 0.01 grams of alcohol per 210 liters of breath when alcohol-free persons are tested; and
7.1.6. Any model of instrument used for the purpose of secondary breath analysis shall be approved in writing by the Bureau. The instrument shall meet or exceed the standards contained in this subsection.
7.2. Methods - The following general methods apply in extracting breath for secondary breath analysis:
7.2.1. The law enforcement officer shall keep the person being tested under constant observation for a period of twenty minutes before the test is administered to ensure that the person has nothing in his or her mouth at the time of the test and that he or she has had no food or drink or foreign matter in his or her mouth during the observation period.
7.2.2. The certified instrument officer conducting the alcohol breath analysis shall perform the evidential test sequence to ensure that the instrument is in proper working condition at the time the person’s alcohol breath analysis test is being conducted.
7.2.3. The alcohol breath analysis shall be administered by a certified instrument operator and in accordance with this rule.
7.2.4. The certified instrument operator conducting the secondary alcohol breath analysis shall use an individual disposable mouthpiece for each person tested.
W. Va. Code R. § 64-10-8 Blood Analysis; Standards and Methods
8.1. Methods of analyzing blood specimens for ethyl alcohol shall meet the following standards:
8.1.1. The method used shall be capable of separating and quantifying ethyl alcohol from the blood specimen;
8.1.2. The method used shall be capable of the analysis of a reference sample of known alcohol concentration within accuracy and precision limits of plus or minus 0.01 grams per cent W/V of the true value. These limits shall be applied to alcohol concentrations which are 0.01 grams per cent W/V or higher;
8.1.3. The method used shall be capable of blood alcohol analysis which results in a concentration less than 0.01 grams of alcohol per one hundred milliliters of blood when alcohol free persons are tested; and
8.1.4. The gas-chromatographic method meets the standards in this subsection for testing.
8.2. Blood for alcohol analysis shall be collected as follows:
8.2.1. The blood shall be drawn only by a licensed doctor of medicine or osteopathy, registered professional nurse, trained medical technician or any medical professional trained in phlebotomy;
8.2.2. Sterile hypodermic needles and syringes shall be used. Sterile disposable units are recommended;
8.2.3. The skin shall not be disinfected with ethyl alcohol. The use of non-alcoholic antiseptics, those which do not contain ethyl alcohol, including 1-1000 aqueous solution of mercuric chloride, aqueous benzalkonium chloride (zephiran), aqueous merthiolate, or other suitable aqueous disinfectants is acceptable;
8.2.4. The quantity of alcohol found in serum shall be divided by a factor of 1.16 to determine the quantity of alcohol in the blood; and
8.2.5. The container (tube or vial) shall be clean and dry, and have an inert, airtight stopper.
Series 100 Pulse Oximetry Newborn Testing
W. Va. Code R. § 64-100-1 General
1.1. Scope -- This rule which implements the Pulse Oximetry Newborn Testing Act requires testing and provides timing requirements for such testing. This rule should be read in conjunction with WV Code §16-44-1 and §16-44-2. The WV Code is available in public libraries and on the Legislature’s web page, http://www.legis.state.wv.us/.
1.2. Authority -- WV Code §§16-44-1 and 16-44-2.
1.3. Filing Date -- July 12, 2013.
1.4. Effective Date -- August 12, 2013.
W. Va. Code R. § 64-100-2 Application
2.1. Application -- This rule applies to all birthing facilities licensed by the Department of Health and Human Resources that provide birthing services and newborn care services.
W. Va. Code R. § 64-100-3 Definitions
3.1. Birthing Facility – An inpatient or ambulatory health care facility licensed by the Department of Health and Human Resources that provides birthing and newborn care services.
3.2. Commissioner – The Commissioner of the Bureau for Public Health or his or her authorized representative.
3.3. Congenital Heart Defects (CHD) - Structural abnormalities of the heart that are present at birth. Some critical congenital heart defects can cause severe and life-threatening symptoms which require intervention within the first days of life.
3.4. Pulse Oximetry Testing - A noninvasive test that estimates the percentage of hemoglobin in blood that is saturated with oxygen.
W. Va. Code R. § 64-100-4 Responsibilities of Birthing Facilities
4.1. A birthing facility shall cause to be performed a pulse oximetry screening on every newborn in its care.
4.2. The pulse oximetry screening shall be performed when the newborn is twenty-four to forty-eight hours of age, or as late as possible if the newborn is to be discharged from the facility before he or she is twenty-four hours of age.
4.3. The pulse oximetry screening results shall be recorded on the newborn’s Birth Score sheet or through an alternate means of data collection that has been approved by the Commissioner.
W. Va. Code R. § 64-100-5 Recommended Protocol for Pulse Oximetry Testing
5.1. The following are recommendations from the United States Secretary of Health and Human Services’ Advisory Committee on Heritable Disorders in Newborns and Children, the American Academy of Pediatrics, and the Centers for Disease Control and Prevention.
5.2. Pulse oximetry should be performed on the right hand and one foot. If the newborn’s oxygen saturation is > 95% in either extremity, with a < 3% difference between the two, he or she will be considered to have passed the screening test and no additional evaluation will be required unless signs or symptoms of CHD are present.
5.3. If the oxygen saturation is <95% in both the hand and foot or there is a >3% difference between the hand and foot on three measures, each separated by one hour, the newborn should be evaluated by his or her pediatrician and referred, if indicated, for an echocardiogram at an ultrasound facility that has experience in newborn cardiac echocardiograms. The echocardiogram shall be interpreted by a pediatric cardiologist who shall then make appropriate arrangements for follow-up when necessary.
5.4. A newborn with oxygen saturation that is <90% in either the hand or foot should be referred immediately for additional evaluation.
5.5. The pulse oximetry guidelines and supporting information may be found online at http:/www.wvdhhr.org/mcfh.
W. Va. Code R. § 64-100-6 Confidentiality
The pulse oximetry screening results recorded on the birth score sheet or other data reporting form are confidential and shall not be released or disclosed to anyone other than the child, his or her parents, guardian or representatives for any reason other than data analysis and planning purposes by public health officials.
W. Va. Code R. § 64-100-7 Administrative Due Process
Any persons adversely affected by the enforcement of this rule desiring a contested case hearing to determine any rights, duties, interests or privileges shall do so in a manner prescribed in the bureau for public health's rule, Rules of Procedure for Contested Case Hearings and Declaratory Rulings, 64CSR1.
64CSR100
Series 103 Expedited Partner Therapy
W. Va. Code R. § 64-103-1 General
1.1. Scope. -- This rule series designates certain diseases as sexually transmitted diseases for the purposes of treatment by expedited partner therapy.
1.2. Authority. -- W. Va. Code § 16-4F-5.
1.3. Filing Date. -- April 13, 2026.
1.4. Effective Date. -- July 1, 2026.
1.5. Sunset Provision. -- This rule shall terminate and have no further force or effect on August 1, 2032.
1.6. Applicability. – This rule series applies to a health care professional who makes clinical diagnosis of a sexually transmitted disease and who desires to provide expedited partner therapy for the treatment of the sexually transmitted disease.
1.7. Purpose -- This rule series is intended to implement the provisions of W. Va. Code §§16-4F-1 et seq. by designating certain diseases as sexually transmitted diseases which may be treated by expedited partner therapy.
W. Va. Code R. § 64-103-2 Definitions
2.1. “Expedited partner therapy” or “EPT” means prescribing, dispensing, furnishing or otherwise providing prescription antibiotic drugs by a health care professional to the sexual partner or partners of a person clinically diagnosed as infected with a sexually transmitted disease without physical examination of the partner or partners.
2.2. “Health care professional” means:
2.2.a. An allopathic physician licensed pursuant to W. Va. Code §§30-3-1 et seq.;
2.2.b. An osteopathic physician licensed pursuant to W. Va. Code §§30-14-1 et seq.;
2.2.c. A physician assistant licensed pursuant to W. Va. Code §30-3E-4;
2.2.d. An advanced practice registered nurse authorized with prescriptive authority pursuant to W. Va. Code §30-7-15a; or
2.2.e. A pharmacist licensed pursuant to W. Va. Code §§ 30-5-1 et seq.
W. Va. Code R. § 64-103-3 Designation of sexually transmitted diseases
Sexually transmitted diseases that may be treated by a health care professional with expedited partner therapy include the following clinically diagnosed sexually transmitted infections:
3.1. Chlamydia trichomatis (chlamydia);
3.2. Neisseria gonorrhea (gonorrhea);
3.3. Bacterial vaginosis; and
3.4. Trichomonas vaginalis.
Series 104 Certification of Opioid Overdose Prevention and Treatment Training Programs
W. Va. Code R. § 64-104-1 General
1.1. Scope. - This rule series establishes standards for certification and procedures for the approval of opioid overdose prevention and treatment training programs for initial responders.
1.2. Authority. - W. Va. Code §§ 16-1-4 & 16-46-6
1.3. Filing Date. -- April 28, 2016
1.4. Effective Date. -- July 1, 2016
1.5. Applicability. - This rule series applies to all persons and entities that intend to offer opioid overdose prevention and treatment programs for the purpose of training initial responders on the proper administration of an opioid antagonist in an emergency situation.
1.6. Purpose - This rule series is intended to implement standards for certification and approval of opioid overdose prevention and treatment training programs authorized by the Access to Opioid Antagonists Act (W.Va. Code §§ 16-46-1 et. seq.).
W. Va. Code R. § 64-104-2 Definitions
2.1. "Curriculum" means a detailed course outline, description, or syllabus submitted to the OEMS as part of the approval process by an association, educational institution, health care facility, or emergency medical services agency sponsoring a training program.
2.2. "Initial responder" means emergency medical service personnel, as defined by W. Va.
Code § 16-4c-3(g), including, but not limited to, a member of the West Virginia State Police, a sheriff, a deputy sheriff, a municipal police officer, a volunteer or paid firefighter and any other person acting under color of law who responds to emergencies.
2.3. "Office of Emergency Medical Services" or "OEMS" means the office under the Commissioner of the Bureau for Public Health pursuant to W. Va. Code §16-4C-4, mandated by the provisions of the "Access to Opioid Antagonists Act" to administer standards for certification and approval of opioid overdose prevention and treatment training programs authorized by the Act.
2.4. "Opiates" or "opioid drugs" means drugs that are members of the natural and synthetic opium family, including, but not limited to, heroin, morphine, codeine, methadone, oxycodone, hydrocodone, fentanyl and hydromorphone.
2.5. "Opioid antagonist" means a federal Food and Drug Administration-approved drug for the treatment of an opiate-related overdose, such as naloxone hydrochloride or other substance, that, when administered, negates or neutralizes, in whole or in part, the pharmacological effects of an opioid in the body.
2.6. "Opioid overdose prevention and treatment training program" or "training program" means any program operated or approved by the Office of Emergency Medical Services.
2.7. "Overdose" means an acute condition, including, but not limited to, life-threatening physical illness, coma, mania, hysteria or death, which is the result of the consumption or use of opioid drugs.
W. Va. Code R. § 64-104-3 Opioid overdose prevention and treatment training programs
3.1. Training programs must contribute directly to the professional competence, skills, and education of initial responders and must educate participants on the following;
3.1.a. The four risk factors for overdose;
3.1.b. Recognizing three signs of an overdose;
3.1.c. Ability to perform techniques to stimulate someone who appears to have overdosed;
3.1.d. Ability to correctly perform rescue breathing; and
3.1.e. Ability to correctly administer naloxone.
3.2. Instructors must demonstrate the necessary practical and academic skills to conduct the courses effectively and meet all standards specified by OEMS, including:
3.2.a. Have working knowledge of opioid drugs, risk factors for overdose, signs of an overdose, use of naloxone with respect to training and naloxone prescription and furnishing;
3.2.b. Be able to communicate with potential responders in an open, nonjudgmental manner using non-technical language;
3.2.c. Be familiar with and sensitive to the health and social experiences of substance users; and
3.2.d. Have mastery of the information and skills addressed in these guidelines, including naloxone administration and rescue breathing.
3.3. Training program materials shall be written and distributed to attendees at or before the time offered, whenever practical;
3.4. Training programs shall be presented in a suitable setting, including on-line or other distributive education methods, appropriate to the educational purpose of the specific course;
3.5. Individuals completing a training program must demonstrate at least the minimum acceptable proficiency in tasks or duties set forth in subsection 3.1. This minimum acceptable proficiency must be determined by the instructor for the course.
3.6. The training program instructor must document an individual's successful completion of the training program in a certificate or letter, the original of which must be given to the individual, containing the following information:
3.6.a. The individual's name;
3.6.b. The individual's date of birth;
3.6.c. The name of the individual's employer;
3.6.d. The date of successful completion of the course;
3.6.e. The course sponsor; and
3.6.f. The course instructor.
3.7. The information required by subsection 3.6. must also be submitted to the OEMS in form or letter signed by the administrator.
W. Va. Code R. § 64-104-4 Approval of Training Programs
4.1. Applications for Training Programs. Any association, educational institution, health care facility or emergency medical services agency may apply to the OEMS for approval to conduct a training program for initial responders.
4.2. Applications for approval of a training program must be made on a form provided by the OEMS, together with the curriculum for the course as defined in section 3. The application must include the following information:
4.2.a. The title of the course;
4.2.b. The sponsor's name;
4.2.c. The name(s) of the course instructor and the instructor is certified to provide training or has received instruction on the course curriculum;
4.2.d. The names and authors of all textbooks to be used, if any, including the publisher and edition, or if no textbook is to be used, a list of written materials to be used, including the source of such materials;
4.2.e. The specific objectives for the course;
4.2.f. Time to be spent on each of the components required by subsection 3.1;
4.2.g. The method(s) of instruction for each component listed in subsection 3.1 (for example, lecture, demonstration, simulation, slide presentation, etc.);
4.2.h. A description of the practical training to be provided for each component listed in subdivision 3.1.c., 3.1.d. and 3.1.e. ;
4.2.i. The reading assignment in the text or in other materials, if any, for each unit;
4.2.j. The evaluation method for each unit (for example, written examination, student presentation or demonstration, competency check-off, etc.);
4.2.k. An explanation of when students will be evaluated (for example, after each unit, comprehensively at the end of the course); and
4.2.1. An explanation of the grading system to be used for written examinations and proficiency evaluations.
4.3. The application and curriculum must be submitted to the OEMS at least 30 days prior to the date on which the course is to be given.
4.4. The application must be submitted by the administrator or operating officer for the entity conducting the course.
4.5. Only applications which are complete will be considered. In order to be considered complete, an application must include:
4.5.a. All of the information requested on the application;
4.5.b. A complete curriculum as defined in section 3; and
4.5.c. The signature of the administrator or operating officer of the entity making application.
4.6 An applicant may submit such additional documents or information as the applicant may consider relevant to the application and compliance with the provisions of this rule series.
4.7. In the event that an application is determined to be incomplete, the OEMS will notify the applicant within 30 days of the receipt of the application of the information necessary to complete the application and retain the application submitted pending receipt of the additional information.
4.8. Continuing Approval: Once an application for approval for a training program has been approved by the OEMS, re-approval is not required for each occasion on which the course is administered so long as the training program is not changed, or so long as the training programing requirements are not changed by law. If the training program, or any portion of a training program, is changed, reapplication must be made in accordance with subsection 4.2. In cases where only a portion of a course is changed, the applicant may submit documentation and information only as to the changes made, but must clearly indicate those portions that are unchanged by so stating on the application.
4.9. Applications to Conduct Approved Courses Developed by Others: Associations, educational institutions, health care facilities, emergency medical services agencies, may, with the consent of the developer(s), conduct training programs developed by others who have received approval from the OEMS. Such facilities must apply for approval in accordance with subsection 4.2, but need not submit curriculum materials required by section 3, except to the extent that the training program, will be varied in any manner from the approved training program. Applicants must indicate on the application the title of the approved training program to be used, name of the entity whose approved course will be used, and the date on which such course was approved.
4.10. Any changes in approved training program must be submitted to the OEMS for prior approval.
4.11. All training programs are subject to on-site periodic review by the OEMS. Sponsors of approved training programs must provide written notice to the OEMS of the date(s) and location that a basic course will be held at least five working days before each occasion on which an approved course is scheduled to begin.
4.12. The approved training program sponsor must maintain attendance records, including the name, address and telephone number of each participant, for such courses for a minimum of two years from the date of completion of each course.
4.13. Attendance records are subject to review by the OEMS upon request.
W. Va. Code R. § 64-104-5 Denial, Suspension, or Revocation of Approval
The OEMS may deny, suspend, or revoke approval of a training program for failure to meet the requirements of W.Va. Code §§ 16-46-1 et seq., as applicable, or the provisions of this
rule series. If the OEMS determines to deny, suspend, or revoke approval of a training program, the OEMS will send the applicant a notice identifying the reasons for the determination. The notice will be sent by either registered or certified mail. The denial, suspension, or revocation will become final 30 days after the mailing of the notice unless the applicant, within that 30-day period, gives written notice of a request for a hearing. Hearings will be conducted in accordance with the Administrative Procedure Act (W.Va. Code §§ 29A-5-1 et seq.), and the Bureau for Public Health
rule series, Rules of Procedure for Contested Case Hearings and Declaratory Rulings (64 CSR 1).
Series 108 Local Board of Health Plans of Combination Procedure
W. Va. Code R. § 64-108 Local Board of Health Plans of Combination Procedure
TITLE 64
PROCEDURAL RULE
BUREAU FOR PUBLIC HEALTH
SERIES 108
LOCAL BOARD OF HEALTH PLANS OF COMBINATION PROCEDURE
General.
Scope. This rule includes procedures for the approval by the commissioner of the Bureau for Public Health of applications by two or more appointing authorities who are seeking to combine local boards of health. This rule provides procedures for submission, evaluation and approval of local board of health plans of combination.
Authority. W.Va. Code §§16-2-5 & 8.
Filing Date – October 24, 2017.
Effective Date – November 25, 2017.
Applicability. This rule series applies to appointing authorities who desire to combine, establish, and maintain a combined local board of health.
Purpose. This procedure describes the manner of submission, evaluation and approval of plans of combination submitted by appointing authorities.
Definitions.
The following words and terms, when used in this rule, have the following meanings, unless the context clearly indicates otherwise:
“Applicants” means two or more appointing authorities seeking approval of a plan to combine local boards of heath.
“Appointing Authority” means the county commission(s) or the governing body, or both, of a municipality.
“Basic Public Health Services” means those services that are necessary to protect the health of the public and that a local board of health must provide. The three areas of basic public health services are communicable and reportable disease prevention and control, community health promotion, and environmental health protection.
“Commissioner” means the commissioner of the West Virginia Bureau for Public Health.
“Center for Local Health” or “CLH” means the unit within the Bureau for Public Health responsible for oversight of the combination program.
“Director” means the director of the Center for Local Health within the Bureau for Public Health.
“Combined Local Board of Health” means a board of health serving any two or more counties or any county or counties and one or more municipalities within or partially within the county or counties.
“Local Board of Health,” “local board,” or “board” means the board of health serving one or more counties or one or more municipalities or a combination thereof.
“Plan of Combination” or “Plan” means the document outlining the intent to combine local boards of health by two or more appointing authorities submitted to the commissioner for approval.
Application and Submission of Plans of Combination.
Appointing authorities for local boards of health may submit a plan of combination at any time.
Applications for combining local boards of health under this rule shall be made in the form and manner as the commissioner may prescribe. The application must include the following information:
Completed application on a form approved by the commissioner;
Justification for the combination;
A description of how basic public services will be maintained to prescribed standards throughout the combination process for all communities served;
A description of how basic public health services will be maintained to prescribed standards for all communities served once the combined board has been established;
A description of anticipated challenges and strategies to address the challenges;
A budget and budget narrative;
A list of the persons assisting in the transition to a combined board of health (including their names, titles, and organizational affiliation) and the available resources, in addition to a brief description of how they will be involved in the project. At a minimum, this must include:
Legal counsel;
Liability insurance;
Fiscal consultant;
Appointing authority; and Local board of health.
Plan (including goals, timeline(s), activities, responsibilities and milestones) that addresses the following:
Service Delivery;
Personnel;
Fiscal;
Legal; and Logistics.
Evidence of engagement with all local boards of health in counties contiguous to the counties proposing to combine, for the purpose of determining whether the local boards of health in the contiguous counties are willing to join the application;
Evidence of public engagement, specifically at least two public meetings during which the public is encouraged and permitted to address the proposed application; and Signed agreement identifying the number of combined local board of health members to be selected by each participating county or municipality (W. Va. Code §16-2-8).
The plan of combination must be signed by the officers of each appointing authority.
Applications may be found online at http://www.dhhr.wv.gov/localhealth/Pages/default.aspx or may be requested from the director by email at dhhrbphclh@wv.gov.
Only applications which are complete will be considered. To be considered complete, an application must include the information contained in subsection 3.2.
Applications may be submitted by one of the following methods:
Website http://www.dhhr.wv.gov/localhealth/Pages/default.aspx;
Email using the following address: dhhrbphclh@wv.gov;
Facsimile using the following fax number: (304) 558-1437; and U.S. Mail at the following address: West Virginia Center for Local Health, 350 Capitol Street, Room 515, Charleston, West Virginia 25301.
A determination on the plan of combination will be made within 30 days of receipt of a complete plan.
Application Review.
Upon receipt of the application, the director will review the application and supporting materials to ensure completeness.
Applications that are determined to be complete will be submitted to the commissioner for review. Applicants will be notified if an application is determined to be incomplete, along with a request to provide the incomplete information or documentation. An application that remains incomplete for 45 days will result in a denial of the application.
The commissioner will evaluate applications using the following criteria:
Degree to which the service area meets or exceeds the minimum and maximum efficiency scale of 100,000 to 500,000 populations. While a minimum population of 100,000 is not a requirement necessary for the approval of an application, plans of combination should strive to achieve a combined population base within the minimum and maximum efficiency scale of 100,000 to 500,000 population. The commissioner acknowledges that in many parts of the state a minimum efficiency of a service population of 100,000 is unachievable. The intent of this criteria is only to maximize the potential for achieving cost efficiency in service delivery, consistent performance of duties relating to basic public health services and other health services, and the enforcement of the laws of this state pertaining to public health;
Contiguous counties or municipalities, or both. Applicants seeking approval to combine must be contiguous. These criteria are intended to exploit the geographic proximity of local boards of health and transportation corridors, thus ensuring as much as possible a cultural fit, which in addition to other factors related to the contiguousness of the combining boards of health, strengthen the qualitative aspects of basic public health services;
Demonstrated commitment of appointing authorities. Signed resolutions of commitment to consolidate from each participating appointing authority (county commission or municipalities, or both) and formation of a mechanism or body to provide oversight of planning process;
Evidence of public engagement. Agendas and summary of public comments from public hearings;
Evidence of engagement with contiguous local boards of health. Proximity of jurisdictions within the proposed consolidation impacts to surrounding jurisdictions. Applications for combination must include contiguous counties and an assessment of interest to consolidate must be conducted with all surrounding jurisdictions. This criterion is intended to exploit the geographic proximity of local boards of health and transportation corridors, thus ensuring as much as possible a cultural fit, which in addition to other factors related to the contiguousness of the combining boards of health, strengthen the qualitative aspects of basic public health services; and Evidence of a comprehensive work plan. A comprehensive plan that guides the process of transitioning to and sustaining a combined board of health. The plan must demonstrate that the combination of the local boards of health will ensure the consistent performance of duties related to basic public health services and other health services and the enforcement of the laws of this state pertaining to public health.
Upon a review of the application and the supporting materials the commissioner may approve, disapprove, or approve the application with conditions.
Notices.
Successful applicants will receive a notice of approval letter, signed by commissioner, via e-mail.
The commissioner may conditionally approve an application contingent upon the successful completion phases of the work plan, and in addition to any other requirement imposed by law or determined by the commissioner to be reasonably necessary to fulfill the purposes of the plan, approval of the application may be subject to specific terms and conditions.
The final approval will not occur until the applicants demonstrate the likelihood of the plan’s success to the commissioner’s satisfaction, supported by such documentation as the commissioner may reasonably require.
The commissioner has the authority to make a final determination to approve a plan to combine local boards of health.
All plans to implement a combination of local boards of health must be completed within a reasonable period of time, to be determined by the commissioner.
Monitoring Implementation of the Plan.
The commissioner may monitor the implementation of the plan to ensure that the process of transitioning to a combined board of health is proceeding satisfactorily and that duties related to basic public health services, other health services, and the enforcement of the laws of this state pertaining to public health are consistently performed.
Appeals.
Applicants adversely affected by a determination of the commissioner pursuant to these rules may request a contested case hearing to determine any rights, duties, interests or privileges and shall do so in a manner prescribed in the Bureau for Public Health rule, Rules of Procedure for Contested Case Hearings and Declaratory Rulings, W.Va. Code §§ 64-1-1 et seq.
64CSR108
Series 109 Medical Cannabis Program - General Provisions
W. Va. Code R. § 64-109-1 General
1.1. Scope. This rule includes general provisions related to the permitting of medical cannabis organizations pursuant to the West Virginia Medical Cannabis Act (W. Va. Code §16A-1-1 et seq.)
1.2. Authority. W. Va. Code §16A-3-1(b).
1.3. Filing Date. May 8, 2025.
1.4. Effective Date. May 8, 2025.
1.5. Sunset Provision. This rule shall terminate and have no further force or effect on August 1, 2030.
1.6. Applicability. This rule applies to a person or entity that desires to hold a permit as a medical cannabis organization in this state.
W. Va. Code R. § 64-109-2 Definitions
2.1. “Act” means the West Virginia Medical Cannabis Act (W. Va. Code §16A-1-1 et seq.)
2.2. “Adverse event” means an injury resulting from the use of medical cannabis dispensed at a dispensary. An injury includes physical harm, mental harm, or loss of function.
2.3. “Adverse loss” means a loss, discrepancy in inventory, or diversion or theft of seeds, immature medical cannabis plants, medical cannabis plants, medical cannabis, funds, or other property of a medical cannabis organization.
2.4. “Advertising” means the publication, dissemination, solicitation, or circulation that is visual, oral, written, or electronic to induce directly or indirectly an individual to patronize a particular dispensary or to purchase particular medical cannabis.
2.5. “Applicant” means a person who wishes to submit or submits an application to the Bureau for a permit to operate as a grower/processor or dispensary, or both, under the Act and this rule.
2.6. “Bureau” means the West Virginia Bureau for Public Health within the West Virginia Department of Health.
2.7. "Cannabis" means all parts of the plant of the genus cannabis, whether growing or not, the seeds thereof, the resin extracted from any part of the plant, and every compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds, or its resin, including cannabis concentrate. "Cannabis" does not include industrial hemp, nor does it include fiber produced from the stalks, oil, or cake made from the seeds of the plant, sterilized seed of the plant which is incapable of germination, or the weight of any other ingredient combined with cannabis to prepare topical or oral administrations, food, drink, or other product.
2.8. “CBD” means Cannabidiol.
2.9. “Caregiver” means an individual designated by a patient or, if the patient is under 18 years of age, an individual authorized under W. Va. Code §16A-5-1 et seq. to deliver medical cannabis.
2.10. “Certified medical use” means the acquisition, possession, use, or transportation of medical cannabis by a patient, or the acquisition, possession, delivery, transportation, or administration of medical cannabis by a caregiver, for use as part of the treatment of the patient's serious medical condition, as authorized in a patient certification issued under the Act, including enabling the patient to tolerate treatment for the serious medical condition.
2.11. “Change in control” means the acquisition by a person or group of persons acting in concert of a controlling interest in an applicant or permittee either all at one time or over the span of a 12-consecutive-month period.
2.12. “Change in ownership” means the addition or removal of a principal, operator, or financial backer, or a change in control of a medical cannabis organization after the Bureau approves an initial permit application or a permit renewal application.
2.13. “Clinical Registrant” means an entity that:
2.13.1. Holds a permit as both a grower/processor and a dispensary; and
2.13.2. Has a contractual relationship with an academic clinical research center under which the academic clinical research center or its affiliate provides advice to the entity, regarding, among other areas, patient health and safety, medical applications and dispensing, and management of controlled substances.
2.14. “Controlled substance” means a drug, substance, or immediate precursor included in Schedules I through V of the West Virginia Uniform Controlled Substance Act (W. Va. Code §60A-2-1 et seq.).
2.15. “Controlling interest” means:
2.15.1. For a publicly traded company, voting rights that entitle a person to elect or appoint one or more of the members of the board of directors or other governing board, or the ownership or beneficial holding of five percent or more of the securities of the publicly traded company; or
2.15.2. For a privately held entity, the ownership of any security in the entity.
2.16. “Dispensary” means:
2.16.1. A person who holds a permit issued by the Bureau to dispense medical cannabis.
2.16.2. The term does not include a health care medical cannabis organization as defined by W. Va. Code §16A-13-1 et seq.
2.17. “Electronic tracking system” means an electronic seed-to-sale system prescribed by the Bureau that is implemented by:
2.17.1. A grower/processor to log, verify, and monitor the receipt, use, and sale of seeds, immature medical cannabis plants, or medical cannabis plants, the funds received by a grower/processor for the sale of medical cannabis to another medical cannabis organization, the disposal of medical cannabis waste, and the recall of defective medical cannabis;
2.17.2. A dispensary to log, verify, and monitor the receipt of medical cannabis product from a grower/processor, the verification of the validity of an identification card presented by a patient or caregiver, the dispensing of medical cannabis product to a patient or caregiver, the disposal of medical cannabis waste, and the recall of defective medical cannabis; and
2.17.3. An approved laboratory to log, verify, and monitor the receipt of samples and test samples for testing, the results of tests performed by the approved laboratory, and the disposal of tested and untested samples.
2.18. “Employee” means an individual who is hired for a wage, salary, fee, or payment to perform work for an applicant or permittee.
2.19. “Excipients” means solvents, chemicals, or materials reported by a medical cannabis organization and approved by the Bureau for use in the processing of medical cannabis.
2.20. “Facility” means a structure and other appurtenances or improvements where a medical cannabis organization grows and processes or dispenses medical cannabis.
2.21. “Family or household member” has the same meaning as it does in W. Va. Code §48-27-204.
2.22. “Financial backer” means an investor, mortgagee, bondholder, note holder, or other source of equity, capital, or other assets other than a financial institution.
2.23. "Financial institution" means:
2.23.1. Any bank or savings association;
2.23.2. A person who is an institution-affiliated party, as that term is defined in the Federal Deposit Insurance Act, 12 U.S.C. § 1813(u);
2.23.3. Any federal credit union or state-chartered credit union, including an institution-affiliated party of a credit union; and
2.23.4. Any benefit association, insurance company, safe deposit company, money-market mutual fund, or similar entity authorized to do business in this state.
2.24. “Form of medical cannabis” means the characteristics of the medical cannabis recommended or limited for a particular patient, including the method of consumption and any particular dosage, strain, variety, and quantity or percentage of medical cannabis, or particular active ingredient.
2.25. “Fund” means the Medical Cannabis Program Fund established in W. Va. Code §16A-9-2.
2.26. “Grower/processor means:
2.26.1. A person who holds a permit from the Bureau under the Act to grow or process medical cannabis.
2.26.2. The term does not include a health care medical cannabis organization as defined under W. Va. Code §16A-13-1 et seq.
2.27. “Health care medical cannabis organization” means a vertically integrated health system approved by the Bureau to dispense medical cannabis or grow and process medical cannabis, or both, in accordance with a research study under W. Va. Code §16A-13-1 et seq.
2.28. “Hydroponic nutrient solution” means a mixture of water, minerals, and essential nutrients without soil used to grow medical cannabis plants.
2.29. “Identification card” means a document issued under W. Va. Code §16A-5-1 that authorizes access to medical cannabis under the Act.
2.30. “Immature medical cannabis plant” means a nonflowering part of a medical cannabis plant that is no taller than eight inches and no wider than eight inches produced from a cutting, clipping, or seedling and that is in a growing/cultivating container that is no larger than two inches wide and two inches tall that is sealed on the sides and bottom.
2.31. “Immediate family” has the same meaning as it does in W. Va. Code §6B-1-3(f).
2.32. “Industrial hemp” means the plant Cannabis, sativa L., and any part of the plant, whether growing or not, containing no greater than one percent tetrahydrocannabinol.
2.33. “Initial permit application” means the document submitted to the Bureau by an applicant that, if approved, grants a permit to an applicant.
2.34. “Laboratory” means a place, establishment, or institution within the State of West Virginia that has been issued a certificate by the Bureau’s Office of Laboratory Services.
2.35. “Limited access area” means any area in a site or within a facility where:
2.35.1. Immature medical cannabis plants or seeds are stored, or medical cannabis plants are growing or being processed into medical cannabis;
2.35.2. Immature medical cannabis plants, medical cannabis plants, medical cannabis, or medical cannabis products are being loaded into or out of transport vehicles;
2.35.3. Medical cannabis is packaged for sale or stored;
2.35.4. Medical cannabis waste is processed, stored, or destroyed; and
2.35.5. Surveillance system devices are stored.
2.36. “Medical cannabis” means cannabis that is grown and sold pursuant to the provisions for certified medical use as set forth in the Act and in a form set forth in the provisions of 64CSR110-10 (Forms of medical cannabis).
2.37. “Medical cannabis container” means a sealed, traceable, food compliant, tamper resistant, tamper evident container used for the purpose of containment of packaged medical cannabis being transported from a grower/processor to a medical cannabis organization or a laboratory.
2.38. “Medical cannabis organization” means:
2.38.1. A dispensary or a grower/processor.
2.38.2. The term does not include a health care medical cannabis organization under sections W. Va. Code §16A-13-1 et seq. or a clinical registrant under W. Va. Code §16A-14-1 et seq.
2.39. “Medical cannabis plant” means a plant which is greater than eight vertical inches in height from where the base of the stalk emerges from the growth medium to the tallest point of the plant, or greater than eight horizontal inches in width from the end of one branch to the end of another branch.
2.40. “Medical cannabis program” means the program authorized under the Act and implemented by the Bureau.
2.41. “Medical cannabis waste” means:
2.41.1. Solid, liquid, semi-solid, or contained gaseous materials that are generated by a grower/processor or an approved laboratory.
2.41.2. The term includes:
2.41.2.a. Unused, surplus, returned, recalled, contaminated, or expired medical cannabis;
2.41.2.b. Any medical cannabis plant material that is not used in the growing, harvesting, or processing of medical cannabis, including flowers, stems, trim, leaves, seeds, dead medical cannabis plants, dead immature medical cannabis plants, unused medical cannabis plant parts, and unused immature medical cannabis plant parts or roots;
2.41.2.c. Spent hydroponic nutrient solution;
2.41.2.d. Unused containers for growing immature medical cannabis plants or medical cannabis plants or for use in the growing and processing of medical cannabis;
2.41.2.e. Unused fertilizers and pesticides;
2.41.2.f. Unused excipients; and
2.41.2.g. Wastewater.
2.42. “Municipality” means an incorporated city or town in this state.
2.43. “Nutrient” means the essential elements and compounds necessary for the growth, metabolism, and development of medical cannabis plants.
2.44. “Nutrient practice” means the use by a grower/processor of essential elements and compounds necessary for the growth, metabolism, and development of seeds, immature medical cannabis plants, or medical cannabis plants.
2.45. “Operational” means the time at which the Bureau determines that a medical cannabis organization is ready, willing, and able to properly carry on the activity for which a permit has been issued, including the implementation of an electronic tracking system.
2.46. “Operator” means an individual who directly oversees or manages the day-to-day business functions for an applicant or permittee and has the ability to direct employee activities onsite and offsite or within a facility for which a permit is sought or has been issued under this rule.
2.47. “Patient” means an individual who:
2.47.1. Has a serious medical condition;
2.47.2. Has met the requirements for certification under the Act; and
2.47.3. Is a resident of the State of West Virginia.
2.48. “Permit” means an authorization issued by the Bureau to an applicant to conduct activities authorized under the Act.
2.49. “Permittee” means a person who has been issued an authorization to operate as a medical cannabis organization under the Act and this rule.
2.50. “Person” means a natural person, corporation, foundation, organization, business trust, estate, limited liability company, licensed corporation, trust, partnership, limited liability partnership, association, or other form of legal business entity.
2.51. “Practitioner” means a physician who is registered with the Bureau under W. Va. Code §16A-4-1.
2.52. “Principal” means an officer, director, or person who directly or beneficially owns securities of an applicant or permittee, or a person who has a controlling interest in an applicant or permittee, or who has the ability to elect the majority of the board of directors of an applicant or permittee, or otherwise control an applicant or permittee, other than a financial institution.
2.53. “Publicly traded company” means a person other than an individual who:
2.53.1. Has a class or series of securities registered under the Securities Exchange Act of 1934 (15 U.S.C.A. §§ 78a—78pp) or on a foreign stock exchange determined by the Bureau to have similar listing and reporting requirements to exchanges that are regulated under the Securities Exchange Act of 1934;
2.53.2. Is a registered management company under the Investment Company Act of 1940 (15 U.S.C.A. §§ 80a-1—80a-64); or
2.53.3. Is subject to the reporting obligations imposed by section 15(d) of the Securities Exchange Act of 1934 (15 U.S.C.A. § 78o(d)), by reason of having filed a registration statement which has become effective under the Securities Act of 1933 (15 U.S.C.A. §§ 77a—77aa).
2.54. “Security” means the term as defined in W. Va. Code §32-4-401(n) of the Uniform Securities Act.
2.55. “Serious medical condition” means any of the following conditions:
2.55.1. Cancer;
2.55.2. Positive status for Human Immunodeficiency Virus or Acquired Immune Deficiency Syndrome;
2.55.3. Amyotrophic lateral sclerosis;
2.55.4. Parkinson's disease;
2.55.5. Multiple sclerosis;
2.55.6. Damage to the nervous tissue of the spinal cord with objective neurological indication of intractable spasticity;
2.55.7. Epilepsy;
2.55.8. Neuropathies;
2.55.9. Huntington's disease;
2.55.10. Crohn's disease;
2.55.11. Post-traumatic stress disorder;
2.55.12. Intractable seizures;
2.55.13. Sickle cell anemia;
2.55.14. Severe chronic or intractable pain of neuropathic origin or severe chronic or intractable pain; or
2.55.15. Terminally ill.
2.56. “Site” means the total area contained within the property line boundaries in which a facility is operated by a medical cannabis organization.
2.57. “Solid waste” means the term as defined in W. Va. Code §22-15-2 of the Solid Waste Management Act.
2.58. “Spent hydroponic nutrient solution” means hydroponic nutrient solution that has been used and can no longer serve the purpose for which it was produced.
2.59. “Terminally ill” means a medical prognosis of life expectancy of approximately one year or less if the illness runs its normal course.
2.60. “THC” means Tetrahydrocannabinol.
2.61. “Transport vehicle” means a vehicle that meets the requirements of the Act and is used to transport medical cannabis between medical cannabis organizations or between medical cannabis organizations and a laboratory.
2.62. “Unit” means the weight or volume of total usable medical cannabis in the finished product, calculated in metric units.
2.63. “Vaporization or nebulization” means the generation of medical cannabis in the form of vapor or fine spray for medicinal inhalation.
W. Va. Code R. § 64-109-3 Records subject to disclosure; confidentiality
3.1. The following records are public records and are subject to disclosure under the West Virginia Freedom of Information Act (W. Va. Code §29A-1-1 et seq.):
3.1.1. An application submitted under the Act, except to the extent that the application contains any of the information listed in subsection 3.2.;
3.1.2. The name, business address, and medical credentials of a practitioner; and
3.1.3. Information regarding penalties or other disciplinary actions taken against a permittee by the Bureau for a violation of the Act.
3.2. The following information is considered confidential, is not subject to the West Virginia Freedom of Information Act, and shall not otherwise be released to a person unless pursuant to court order:
3.2.1. Information in the possession of the Bureau or any of its contractors regarding a practitioner's registration information that is not listed as a public record under subsection 3.1;
3.2.2. The name or other personal identifying information of a patient or caregiver who applies for or is issued an identification card;
3.2.3. A patient certification issued by a practitioner;
3.2.4. Any information on an identification card;
3.2.5. Information provided by the West Virginia State Police regarding a caregiver, including criminal history record information, as set forth in section 7 (Background checks);
3.2.6. Information regarding a patient's serious medical condition.
3.2.7. Other information regarding a patient, caregiver, practitioner, or medical cannabis organization not included in subsection 3.1. that falls within an exception to the West Virginia Freedom of Information Act or is otherwise considered to be confidential proprietary information by other law.
3.2.8. Information regarding the physical features of, and security measures installed in, a facility; and
3.2.9. Information maintained in the electronic tracking system of a grower/processor and a dispensary.
3.3. An applicant must identify and mark confidential proprietary information as confidential proprietary information prior to submission to the Bureau.
W. Va. Code R. § 64-109-4 General requirements for application
4.1. The types of applications to be submitted to the Bureau under these rules include:
4.1.1. An initial permit application;
4.1.2. A permit renewal application;
4.1.3. An application for approval of a change in ownership of a medical cannabis organization authorized by a permit;
4.1.4. An application for approval of a change of location of a facility authorized by a permit;
4.1.5. An application for approval of alteration of a facility authorized by a permit; and
4.1.6. An application for an additional grower location.
4.2. By submitting an application to the Bureau, an applicant consents to any investigation of the applicant's ability to meet the requirements under the Act applicable to the application.
4.3. An application is not complete and shall be rejected by the Bureau unless:
4.3.1. The payment of the applicable application and permit fees in section 5 (Fees) are submitted with the application;
4.3.2. The applicant and its principals, and other persons affiliated with the applicant, are current in all tax obligations due and owing to the state. An applicant, as part of the application, must provide tax clearance certificates issued by the W. Va. State Tax Department and WorkForce West Virginia for the applicant and its principals and other affiliated persons verifying that the applicant does not have outstanding tax obligations to the state. The Bureau may consider the application to be complete if the applicant states on a form prescribed by the W. Va. State Tax Department and WorkForce West Virginia that tax clearance certificates have been requested at the time the application was submitted to the Bureau; and
4.3.3. All required information for each section of the application, including attachments and any supplemental information required by the Bureau, is submitted to the Bureau.
4.4. If an application is rejected by the Bureau, the applicant shall be notified by the Bureau and the initial permit fee shall be refunded.
4.5. An application submitted under these rules must contain the following statement signed by the applicant: “A false statement made in this application is punishable under the applicable provisions of W. Va. Code §61-3-37.”
W. Va. Code R. § 64-109-5 Fees
5.1. An applicant for an initial grower/processor permit or renewal permit must pay the following fees by certified check or money order to the Bureau:
5.1.1. Initial permit application fee. The initial permit application fee of $5,000 must be submitted with the initial permit application and is nonrefundable, except as provided in subsection 4.4 and subdivision 6.1.3.;
5.1.2. Initial permit fee. The initial permit fee of $50,000 must be submitted with the initial permit application and shall be refunded if the initial permit is not granted; and
5.1.3. Permit renewal fee. The permit renewal fee of $5,000 must be submitted with a renewal application and shall be refunded if the renewal permit is not granted.
5.2. An applicant for an initial dispensary permit or renewal permit must pay the following fees by certified check or money order to the Bureau:
5.2.1. Initial permit application fee. The initial permit application fee of $2,500 must be submitted with the initial permit application and is nonrefundable, except as otherwise provided in these rules;
5.2.2. Initial permit fee. The initial permit fee of $10,000 for each dispensary location must be submitted with the initial permit application and shall be refunded if the initial permit is not granted; and
5.2.3. Permit renewal fee. The permit renewal fee of $2,500 must be submitted with a renewal application and shall be refunded if the renewal permit is not granted.
5.3. A medical cannabis organization must pay a fee of $250 by certified check or money order to the Bureau with the submission of the following:
5.3.1. An application for approval of a change in ownership of a medical cannabis organization;
5.3.2. An application for approval of a change of location of a facility authorized by a permit; or
5.3.3. An application for approval of alteration of a facility authorized by a permit.
W. Va. Code R. § 64-109-6 Initial permit application
6.1. The Bureau shall publish in the State Register and on the Bureau’s website notice of initial permit application availability and the time frame during which initial permit applications will be accepted.
6.1.1. An applicant may only use the initial permit application form prescribed by the Bureau made available on its web site.
6.1.2. An applicant must submit an initial permit application to the Bureau in a manner prescribed by the initial permit application instructions.
6.1.3. An initial permit application received from an applicant after the time frame during which the Bureau is accepting applications shall be rejected by the Bureau and returned to the applicant without further consideration along with the return of fees submitted by the applicant with the application.
6.2. In addition to the requirements in section 4 (General requirements for application), the applicant must provide the Bureau with the following information in the initial permit application:
6.2.1. The legal name of the applicant;
6.2.2. Certified copies of the applicant's organizational documents, if applicable, and if the applicant was not organized in this state, evidence that it is authorized to conduct business in this state;
6.2.3. The physical address of the applicant's proposed site and facility, including the following, as applicable:
6.2.3.a. Evidence of the applicant's clear legal title to or option to purchase the proposed site and the facility;
6.2.3.b. A fully executed copy of the applicant's unexpired lease for the proposed site and facility that includes the consent by the property owner to the use by the applicant of that site and facility on the proposed site for, at a minimum, the term of the initial permit; or
6.2.3.c. Other evidence satisfactory to the Bureau that shows the applicant has the authority to use the proposed site and facility as a site and facility for, at a minimum, the term of the permit.
6.2.4. Evidence that the applicant is or will be in compliance with the zoning requirements of any municipality in which the applicant intends to operate.
6.2.5. The following apply to the proposed facility:
6.2.5.a. If the facility is in existence at the time the initial permit application is submitted to the Bureau, the applicant must submit plans and specifications drawn to scale for the interior of the facility.
6.2.5.b. If the facility is in existence at the time the initial permit application is submitted to the Bureau, and the applicant intends to make alterations to the facility, the applicant must submit renovation plans and specifications for the interior and exterior of the facility to be altered.
6.2.5.c. If the facility is not in existence at the time the initial permit application is submitted to the Bureau, the applicant must submit a plot plan that shows the proposed location of the facility and an architect's drawing of the facility, including a detailed drawing, to scale, of the interior of the facility.
6.2.6. The name, residential address, date of birth, title, and a curriculum vitae of each principal, operator, financial backer, and employee of the applicant, or of any person holding an interest in the applicant's proposed site or facility, including:
6.2.6.a. A verification of identity that is satisfactory to the Bureau;
6.2.6.b. Evidence of good moral character and reputation of each principal, operator, financial backer, or employee; and
6.2.6.c. A copy of a criminal history records check for each individual performed in accordance with section 7 (Background checks). This paragraph does not apply to an applicant who is an owner of securities in a publicly traded company if the Bureau determines that the owner of the securities is not substantially involved in the activities of the applicant.
6.2.6.d. An affidavit from each principal or operator of the applicant setting forth the following:
6.2.6.d.1. Any position of management or ownership held during the 10 years preceding the filing date of the initial permit application of a controlling interest in any other business in this state or any other jurisdiction involving the manufacturing or distribution of medical cannabis or a controlled substance; and
6.2.6.d.2. Whether the principal, operator, or financial backer has been convicted of a felony criminal offense.
6.2.7. If a principal, operator, or financial backer is a corporation or limited liability company:
6.2.7.a. The names, residential addresses, titles, and the curricula vitae of each principal of the corporation or limited liability company;
6.2.7.b. A certified copy of the filed articles of incorporation of the corporation or filed certificate of organization of the limited liability company; and
6.2.7.c. Unless the corporation or limited liability company is a publicly traded company, the names and mailing addresses of all persons owning securities in the corporation or membership interests in the limited liability company.
6.2.8. If a principal, operator, or financial backer is a general partnership, limited partnership, limited liability partnership, or limited liability limited partnership:
6.2.8.a. The names, residential addresses, titles, and the curricula vitae of each partner and general partner of a general partnership, limited partnership, limited liability partnership, or limited liability limited partnership, and if any of the partners is a corporation or a limited liability company, the names, residential addresses, titles, and short version of the curricula vitae of each principal of that corporation or limited liability company;
6.2.8.b. A certified copy of its filed certificate of limited partnership or other formation document, if applicable;
6.2.8.c. A certified copy of its partnership agreement; and
6.2.8.d. Unless the entity is a publicly traded company, the names, and mailing addresses of each of its partners.
6.2.9. Evidence that the applicant is responsible and capable of successfully establishing and operating a facility, including the following:
6.2.9.a. Demonstrated experience, if any, running a for-profit or nonprofit organization or other business within this state or any other jurisdiction, and the nature of the business conducted by the organization;
6.2.9.b. History relating to a similar license, permit, or other authorization in other jurisdictions, including provisional licenses, suspensions, revocations, or disciplinary actions, including civil monetary penalties or warnings;
6.2.9.c. History of response to sanctions, disciplinary actions, or civil monetary penalties imposed relating to any similar license, permit, or other authorization in another jurisdiction, and the plans of correction or other responses made to those actions;
6.2.9.d. Evidence that the applicant and its principals, and other persons affiliated with the applicant identified by the Bureau, is in compliance with all the laws of the state regarding the payment of state taxes as shown on the tax clearance certificates issued by the West Virginia State Tax Department and Workforce West Virginia under section 4;
6.2.9.e. Evidence of any felony criminal action under the laws of the state or any other state, the United States or a military, territorial, or tribal authority, against a principal, operator, financial backer, or employee, or which involved the possession, transportation, or sale of illegal drugs, or which related to the provision of cannabis for medical purposes, including any action against an organization providing cannabis for medical purposes in which those individuals either owned shares of stock or served as executives, and which resulted in a conviction, guilty plea, or plea of nolo contendere, or an admission of sufficient facts;
6.2.9.f. Evidence of any civil or administrative action under the laws of the state or any other state, the United States or a military, territorial, or tribal authority relating to a principal, operator, financial backer, or employee of the applicant's profession, or occupation or fraudulent practices, including fraudulent billing practices;
6.2.9.g. Evidence of any attempt by the applicant to obtain a registration, license, permit, or other authorization to operate a medical cannabis organization in any jurisdiction by fraud, misrepresentation, or the submission of false information; and
6.2.9.h. A statement that the applicant must provide evidence of workers' compensation insurance if the applicant is issued a permit and the facility is determined to be operational by the Bureau.
6.2.10. A description of the duties, responsibilities, and roles of each principal, operator, financial backer, and employee;
6.2.11. A timetable outlining the steps the applicant will take to become operational;
6.2.12. A summary of the intended plan of operation that describes, at a minimum, how the applicant's proposed business operations will comply with the Act and these rules relating to:
6.2.12.a. Security;
6.2.12.b. Employee qualifications and training;
6.2.12.c. Transportation of medical cannabis;
6.2.12.d. Storage of medical cannabis;
6.2.12.e. Labeling of medical cannabis;
6.2.12.f. Inventory management;
6.2.12.g. With respect to a grower/processor's facility, nutrient practice;
6.2.12.h. With respect to a grower/processor's facility, quality control and testing of medical cannabis for potential contamination;
6.2.12.i. Recordkeeping;
6.2.12.j. Preventing unlawful diversion of medical cannabis; and
6.2.12.k. With respect to a grower/processor's facility, growing of medical cannabis, including a detailed summary of policies and procedures for its growth.
6.2.13. The relevant financial information in section 25 (capital requirements);
6.2.14. Statements that:
6.2.14.a. The applicant and each principal, operator, financial backer, and employee are of good moral character;
6.2.14.b. The applicant possesses the ability to obtain in an expeditious manner the right to use the proposed site and facility, including equipment, to properly perform the activity described in the initial permit application;
6.2.14.c. The applicant can continuously maintain effective security, surveillance, and accounting control measures to prevent diversion, abuse, and other illegal conduct regarding medical cannabis plants and medical cannabis; and
6.2.14.d. The applicant can continuously comply with all applicable laws of the state, the Act, these rules, and the terms and conditions of the initial permit;
6.2.15. The applicant must provide the Bureau with releases sufficient to obtain information from a governmental agency, financial institutions, an employer, or any other person. Failure to provide these releases will result in the rejection of the initial permit application; and
6.2.16. Other information required by the Bureau.
6.3. If the Bureau determines that an initial permit application is complete but lacking sufficient information upon which to make a determination, the Bureau will notify the applicant in writing of the factors that require additional information and documentation. An applicant has 30 days from the mailing date of the notice to provide the requested information and documentation to the Bureau. An applicant's failure to provide the requested information to the Bureau by the deadline may be grounds for denial of the issuance of a permit.
6.4. At the discretion of the Bureau, the Bureau may extend the deadline in subsection 6.3 for up to an additional 15 days.
6.5. The Bureau may conduct an inspection to determine the appropriateness of a proposed site and facility, the applicant's operational status, the applicant's compliance with the laws and rules of the state, the municipality's zoning requirements relating to the applicant's proposed site and facility, if applicable, and its use as outlined in the permit application. The Bureau may do the following:
6.5.1. Interview principals, operators, financial backers, and employees, including physicians and pharmacists, engaged and to be engaged in the applicant's operations for the purpose of verifying the information contained in the initial permit application.
6.5.2. Inspect transport vehicles that are or will be utilized in the transportation of medical cannabis to a facility or a laboratory.
W. Va. Code R. § 64-109-7 Background checks
7.1. To provide the criminal history record check required under section 6 (Initial permit application), an applicant must submit fingerprints of its principals, financial backers, operators, and employees to the West Virginia State Police. The West Virginia State Police or its authorized agent must submit the fingerprints to the Federal Bureau of Investigation for the purpose of verifying the identity of the individuals whose fingerprints have been submitted and obtaining a current record of criminal arrests and convictions.
7.2. The Bureau may only use criminal history background check information obtained under this section to determine the character, fitness, and suitability to serve in the designated capacity of the principal, financial backer, operator, and employee.
7.3. This section does not apply to an owner of securities in a publicly traded company if the Bureau determines that the owner is not substantially involved in the activities of the medical cannabis organization.
7.4. A financial backer, principal, or employee may not hold a volunteer position, position for remuneration, or otherwise be affiliated with a medical cannabis organization or a clinical registrant if the individual has been convicted of a criminal offense relating to the sale or possession of illegal drugs, narcotics, or controlled substances.
W. Va. Code R. § 64-109-8 Review of initial permit applications
8.1. The Bureau will review initial permit applications submitted by applicants according to the criteria in W. Va. Code §16A-6-3(a) and this rule.
W. Va. Code R. § 64-109-9 Permit renewal applications
9.1. A medical cannabis organization wishing to renew its permit must submit to the Bureau a permit renewal application not more than six months, nor less than four months, prior to the current permit's expiration.
9.2. A medical cannabis organization must submit the applicable fee in section 5 (Fees) with the permit renewal application.
9.3. A medical cannabis organization must include the following in the permit renewal application:
9.3.1. Information regarding any charge, or any initiated, pending, or concluded investigation, during the period of the initial permit or prior renewal period, by any governmental, or administrative agency with respect to:
9.3.1.a. Any incident involving the theft, loss, or possible diversion of medical cannabis by the medical cannabis organization or from the medical cannabis organization's facility.
9.3.1.b. Compliance by the medical cannabis organization with the laws of the state with respect to any substance in the Uniform Controlled Substance Act (W. Va. Code §60A-4-401 et seq.)
9.3.1.c. Information concerning the medical cannabis organization's ability to carry on the activity for which the permit was issued, including medical cannabis product shortages or wait lists occurring during the 12-months prior to the date the renewal permit application was submitted.
9.3.1.d. The medical cannabis organization's history of compliance with the Act and the legislative rules promulgated pursuant to the Act.
9.4. If the Bureau determines that a permit renewal application is complete but lacking sufficient information upon which to make a determination, the Bureau will notify the medical cannabis organization in writing of the factors that require additional information and documentation. The medical cannabis organization will have 30 days from the mailing date of the notice to provide the requested information and documentation to the Bureau. A medical cannabis organization's failure to provide the requested information to the Bureau by the deadline may be grounds for denial of the permit renewal application.
9.5. The Bureau may conduct an onsite inspection of the medical cannabis organization's site and facility to determine an applicant's continuing compliance with the Act and the legislative rules promulgated pursuant to the Act.
W. Va. Code R. § 64-109-10 Denial of renewal of a permit
10.1. The Bureau will deny the renewal of a permit if the Bureau determines:
10.1.1. The medical cannabis organization has not or is unlikely to be able to continuously maintain effective control against diversion of medical cannabis at its facility.
10.1.2. The medical cannabis organization falsified any part of the permit renewal application or any other application submitted to the Bureau under this rule.
10.1.3. The medical cannabis organization is unlikely to comply with all state and local laws applicable to the activities in which it may engage under the permit, if renewed.
10.2. An existing permit is immediately invalid upon expiration if the medical cannabis organization has not filed a permit renewal application in accordance with section 9 (Permit renewal applications) and remitted the required fees in accordance with section 5 (Fees).
10.3. Except as provided in subsection 10.5, a medical cannabis organization may not operate if its permit is not renewed prior to expiration.
10.4. If the Bureau denies renewal of the permit or if the medical cannabis organization fails to submit a permit renewal application and permit renewal fee as required under section 5 (Fees) the medical cannabis organization must do the following upon the expiration of the permit:
10.4.1. Cease all operations authorized by the permit.
10.4.2. In the case of a grower/processor, dispose of any remaining medical cannabis, medical cannabis products, plant matter, seed, or any growing equipment as set forth in 64CSR110-22.
10.4.3. In the case of a dispensary, return the medical cannabis or medical cannabis products to the grower/processor where the medical cannabis and medical cannabis products originated.
10.5. If a medical cannabis organization submits a permit renewal application and permit renewal fee to the Bureau as required under section 5 (Fees), the Bureau may administratively extend the existing permit from the date the existing permit expires until the Bureau can complete its permit renewal application review.
W. Va. Code R. § 64-109-11 Duty to report
11.1. During the application process, or at any time during the permit period if a permit is issued, an applicant or permittee must notify the Bureau:
11.1.1. In writing of any change in facts or circumstances reflected in the initial permit application or any permit renewal application submitted to the Bureau, or any newly discovered or occurring fact or circumstance which would have been included in the application if known at the time the application was submitted.
11.1.2. In writing of any proposed modification of its plan of operation at least 30 days prior to the proposed modification.
11.1.3. Immediately upon becoming aware, and state and local law enforcement immediately upon becoming aware, of any adverse loss from the permittee's facility or any vehicle transporting medical cannabis to or from the permittee's facility.
11.2. If the change in information involves a change in control of the medical cannabis organization, the medical cannabis organization must surrender its existing permit to the Bureau, unless the medical cannabis organization submits an application for approval of a change in ownership of a medical cannabis organization in accordance with section 12 (Application for approval of a change in ownership of a medical cannabis organization).
11.3. If the change in information involves a change in any of the activities on the medical cannabis organization site, including any of the following, the medical cannabis organization must surrender its existing permit to the Bureau and take action as required under section 16 (Closure of a facility):
11.3.1. Discontinuance of operations.
11.3.2. Removal of all medical cannabis from the sites and locations by state or federal authority.
W. Va. Code R. § 64-109-12 Application for approval of a change in ownership of a medical cannabis organization
12.1. In the event of an impending change in ownership of a medical cannabis organization from the ownership listed in the initial permit application or a permit renewal application, the medical cannabis organization must submit an application for approval of a change in ownership, on a form prescribed by the Bureau, to the Bureau together with the fee required under section 5 (Fees).
12.2. The Bureau, in its sole discretion, may permit the medical cannabis organization to incorporate by reference all of the information in the medical cannabis organization’s initial permit application, and any previously submitted permit renewal application, into the application for approval of a change in ownership.
12.3. A medical cannabis organization’s application for approval of a change in ownership will not be considered complete by the Bureau until all portions of the application are completed and the appropriate application fee contained in section 6 is submitted. The Bureau may reject an incomplete application.
12.4. For each individual that is part of the proposed change in ownership, the medical cannabis organization must include all of the information required under section 6 (Initial permit application) for the individuals listed in those capacities in the medical cannabis organization’s initial permit application or any previously submitted permit renewal application.
12.5. If the Bureau determines that an application for approval of a change in ownership is lacking sufficient information upon which to make a determination, the Bureau will notify the medical cannabis organization in writing of the factors that require additional information and documentation. The medical cannabis organization has 30 days from the mailing date of the notice to provide the requested information and documentation to the Bureau. A medical cannabis organization’s failure to provide the required information and documentation to the Bureau by the deadline may be grounds for the denial of approval for the requested change in ownership.
12.6. A change in ownership of a medical cannabis organization that occurs without the Bureau’s prior written approval of the change as provided in this section is a violation of the Act and these rules.
W. Va. Code R. § 64-109-13 Application for approval of a change in location of a facility
13.1. A medical cannabis organization desiring to change the location of a site or facility authorized under a permit issued to the medical cannabis organization must submit an application for approval of a change in location to the Bureau together with the fee required by section 5 (Fees).
13.2. A change in location of a facility authorized by a permit may not occur until the Bureau approves the change, in writing.
13.3. The medical cannabis organization must submit an application for approval of a change in location on a form prescribed by the Bureau.
13.4. An application for approval of a change in location must include the reason for requesting the change and other information about the new location as the Bureau may require.
13.5. The Bureau will issue a new permit to the medical cannabis organization for the new location if the request is approved.
13.6. Within 180 days of the issuance by the Bureau of a new permit under subsection 13.5, the medical cannabis organization must change the location of its operation to the new location designated in the new permit. Simultaneously with the completion of the move, the medical cannabis organization must cease to operate at the former location and surrender its existing permit to the Bureau. The following conditions apply:
13.6.1. At no time may a medical cannabis organization operate or exercise any of the privileges granted under the permit in both locations;
13.6.2. At the discretion of the Bureau, the Bureau may extend the 180-day deadline for relocation for up to an additional 90 days; and
16.6.3. Once the new facility is determined to be operational by the Bureau, the medical cannabis organization may resume operations under the new permit at the new location.
W. Va. Code R. § 64-109-14 Application for approval of alteration of a facility
14.1. Except as provided in subsection 14.2, after the issuance of a permit, a medical cannabis organization may not make a physical change, alteration, or modification of the facility that materially or substantially alters the facility or its usage as described in the plot plans originally approved by the Bureau.
14.2. A medical cannabis organization wishing to make any of the following alterations to the facility for which its permit was issued must submit an application for approval of alteration of a facility, on a form prescribed by the Bureau, to the Bureau together with the fee required by section 5 (Fees):
14.2.1. An increase or decrease in the total square footage of the facility;
14.2.2. The sealing off, creation of, or relocation of a common entryway, doorway, passage, or other means of public ingress or egress when the common entryway, doorway, or passage alters or changes limited access areas;
14.2.3. Any of the following made to enhance activities authorized under the permit:
14.2.3.a. Additional electric fixtures or lighting equipment;
14.2.3.b. The lowering of a ceiling; and
14.2.3.c. Electrical modifications that require inspection by state or local governmental entity.
W. Va. Code R. § 64-109-15 Failure to be operational
15.1. No more than six months from the date of issuance of a permit, a medical cannabis organization must notify the Bureau, on a form prescribed by the Bureau, that it is operational.
15.2. After the Bureau receives the notification in subsection 15.1, the Bureau will inspect the facility to determine if the medical cannabis organization is operational to the satisfaction of the Bureau.
15.3. If the medical cannabis organization has not met the operational timetable in the initial permit application to the satisfaction of the Bureau at the time of the inspection conducted under subsection 15.2, the Bureau will notify the medical cannabis organization of the deficiencies. Within 30 days of receiving the Bureau's notice, the medical cannabis organization must submit to the Bureau for approval a plan of correction that sets forth the medical cannabis organization's timeline and a date certain for correcting the deficiencies, which may not extend beyond 90 days following the date the Bureau approves the plan of correction.
15.4. If the medical cannabis organization does not comply with its plan of correction as approved by the Bureau within 90 days following the Bureau's approval, the Bureau may revoke or suspend the medical cannabis organization's permit under section 20 (General penalties and sanctions).
W. Va. Code R. § 64-109-16 Closure of a facility
16.1. A medical cannabis organization must notify the Bureau in writing immediately, but in no event less than 60 days prior to the projected date of closure, upon making a determination that it intends to close its facility.
16.2. A medical cannabis organization may not accept or purchase seeds, immature medical cannabis plants, medical cannabis plants, medical cannabis, other plant matter, medical cannabis products, equipment, or medical devices or instruments as of the date of notice submitted pursuant to subsection 16.1.
16.3. The notice must be accompanied by the medical cannabis organization's written plan for closing the facility which must include the following information:
16.3.1. The projected date of closure.
16.3.2. How it intends to notify in writing, prior to the projected date for closure, any person to which the medical cannabis organization provides medical cannabis or medical cannabis services prior to closure.
16.3.3. How it intends to dispose of seeds, immature medical cannabis plants, medical cannabis plants, medical cannabis, medical cannabis products, or other plant matter projected to still be in the facility at the time of the projected closure in accordance with 64CSR110-22.
16.3.4. How it intends to dispose of equipment or medical devices or instruments used by the medical cannabis organization in its operations at the facility.
16.4. A medical cannabis organization may not remove or destroy any seeds, immature medical cannabis plants, medical cannabis plants, medical cannabis, other plant matter, medical cannabis products, equipment, or medical devices or instruments until the Bureau has approved its plan for closure submitted under subsection 16.3 and must comply with all requirements regarding disposal of medical cannabis 64CSR110-22 (Management and disposal of medical cannabis waste).
16.5. The Bureau may enter the site and facility and inspect the medical cannabis organization's vehicles following receipt of a medical cannabis organization's plan of closure to determine whether to approve the medical cannabis organization's closure plan.
16.6. If the Bureau approves the medical cannabis organization's plan to close the facility submitted under this section, the medical cannabis organization must surrender its permit to the Bureau on or before the date for closure provided in the plan.
W. Va. Code R. § 64-109-17 Insurance requirements
17.1. A medical cannabis organization must obtain and maintain an appropriate amount of insurance coverage that insures the site, facility, and equipment used in the operation of the facility. An adequate amount of comprehensive liability insurance covering the medical cannabis organization’s activities authorized by the permit must begin on the date the initial permit is issued by the Bureau and continuing for a long as the medical cannabis organization is operating under the permit.
17.2. A medical cannabis organization must obtain and maintain workers’ compensation insurance coverage for employees at the time the medical cannabis organization is determined to be operational by the Bureau.
W. Va. Code R. § 64-109-18 Inspection and investigation
18.1. The Bureau may conduct announced or unannounced inspections or investigations to determine the medical cannabis organization's compliance with its permit, the Act or the legislative rules promulgated pursuant to the Act.
18.2. An investigation or inspection may include:
18.2.1. Inspection of a medical cannabis organization's site, facility, vehicles, books, records, papers, documents, data, and other physical or electronic information.
18.2.2. Questioning of employees, principals, operators, and financial backers of the medical cannabis organization.
18.2.3. Inspection of a grower/processor facility's equipment, instruments, tools, and machinery that are used to grow, process, and package medical cannabis, including containers and labels.
18.3. The Bureau and its authorized agents will have free access to review and, if necessary, make copies of books, records, papers, documents, data, or other physical or electronic information that relates to the business of the medical cannabis organization, including financial data, sales data, shipping data, pricing data, and employee data.
18.4. Failure of a medical cannabis organization to provide the Bureau and its authorized agents immediate access to any part of a medical cannabis organization's site or facility, requested material, physical or electronic information, or individual as part of an inspection or investigation may result in the imposition of a civil monetary penalty, suspension, or revocation of its permit, or an immediate cessation of operations pursuant to a cease and desist order issued by the Bureau.
18.5. The Bureau and its authorized agents will have free access to any area within a site or facility that is being used to store medical cannabis for testing purposes and are permitted to collect test samples for testing at an approved laboratory.
W. Va. Code R. § 64-109-19 Reports
19.1. A medical cannabis organization must submit the following reports to the Bureau, on forms prescribed by the Bureau, at the end of the first 12-month period following the issuance of a permit, and at the end of each three-month period thereafter:
19.1.1. In the case of a grower/processor:
19.1.1.a. The amount of medical cannabis sold by the grower/processor during the period for which the report is being submitted.
19.1.1.b. The per-dose price of an amount of medical cannabis sold by the grower/processor to a medical cannabis organization in a unit of measurement as determined by the Bureau.
19.1.2. In the case of a dispensary:
19.1.2.a. The amount of medical cannabis purchased by the dispensary during the period for which the report is being submitted.
19.1.2.b. The per-dose price of medical cannabis purchased by a dispensary in a unit of measurement as determined by the Bureau.
19.1.2.c. The per-dose price of an amount of medical cannabis dispensed to a patient or caregiver by a dispensary and in a unit of measurement as determined by the Bureau.
19.2. The Bureau will aggregate the information in the reports submitted by medical cannabis organizations under subsection 19.1 and post the information on the Bureau's web site.
19.3. The Bureau may require ongoing reporting of operational and financial information in a form and manner prescribed by the Bureau.
19.4. The Bureau may require any reports necessary to carry out its responsibilities under the Act and the legislative rules promulgated pursuant to the Act.
W. Va. Code R. § 64-109-20 General penalties and sanctions
20.1. In addition to any other penalty imposed by law for violations of the Act or the legislative rules promulgated pursuant to the Act, the Bureau may take one or more of the following actions:
20.1.1. Suspend or revoke a permit if any of the following occur:
20.1.1.a. The medical cannabis organization fails to maintain effective control against diversion of medical cannabis from its facility or under its control;
20.1.1.b. The medical cannabis organization violates a provision of the Act or these rules, an order issued under the Act or the legislative rules promulgated pursuant to the Act;
20.1.1.c. The medical cannabis organization violates a provision of other state or local laws regarding the operation if its facility; or
20.1.1.d. The medical cannabis organization engages in conduct, or an event occurs, that would have disqualified the medical cannabis organization from being issued a permit or having its permit renewed.
20.1.2. Impose a civil penalty of not more than $10,000 for each violation and an additional penalty of not more than $1,000 for each day of the continuing violation. In determining the amount of each penalty, the Bureau will take the following into consideration:
20.1.2.a. The gravity of the violation.
20.1.2.b. The potential harm resulting from the violation to patients, caregivers, or the general public.
20.1.2.c. The willfulness of the violation.
20.1.2.d. Previous violations, if any, by the medical cannabis organization being assessed.
20.1.2.e. The economic benefit to the person being assessed for failing to comply with the requirements of the Act, the legislative rules promulgated pursuant to the Act, or an order issued under the Act or those rules.
20.1.3. Suspend or revoke a permit pending the outcome of a hearing if the Bureau determines that the health, safety, or welfare of the public, a patient, or a caregiver is at risk;
20.1.4. Order the restitution of funds or property unlawfully obtained or retained by a medical cannabis organization;
20.1.5. Issue a cease and desist order to immediately stop or restrict the operations of a medical cannabis organization conducted under a permit to protect the public’s health, safety, and welfare. The following apply:
20.1.5.a. An order may include a requirement that a medical cannabis organization cease or restrict some or all of its operations. In addition, the order may prohibit the use of some or all of the medical cannabis grown, processed, or to be sold by the medical cannabis organization;
20.1.5.b. An order may be issued by an authorized agent of the Bureau immediately upon the completion of an inspection or investigation if the agent observes or suspects an operational failure or determines that the conditions will likely create a diversion of medical cannabis, contamination of medical cannabis, or a risk to patients or the public; and
20.1.5.c. An order may include:
20.1.5.c.1. An immediate evacuation of the site and facility, and the sealing of the entrances to the facility;
20.1.5.c.2. A quarantine of some or all of the medical cannabis found at the facility; and
20.1.5.c.3. The suspension of the sale or shipment of some or all of the medical cannabis found at the facility.
20.1.6. Issue a written warning if the Bureau determines that either:
20.1.6.a. The public interest will be adequately served under the circumstances by the issuance of the warning; or
20.1.6.b. The violation does not threaten the safety or health of a patient, caregiver, or the general public, and the medical cannabis organization took immediate action to remedy the violation.
20.2. A person who aids, abets, counsels, induces, procures, or causes another person to violate the Act the legislative rules promulgated pursuant to the Act, or an order issued under the Act, or those rules, will also be subject to the civil penalties provided for under this section.
20.3. Before the Bureau may act under subsection 20.1 or 20.2, the Bureau will provide the medical cannabis organization or other person with written notice specifying the nature of the alleged violation or conduct.
20.4. Notwithstanding subsection 20.3, for violations of the Act or the legislative rules promulgated pursuant to the Act, the Bureau may require a medical cannabis organization to develop and adhere to a plan of correction approved by the Bureau. The Bureau will monitor compliance with the plan of correction. Failure to comply with the plan of correction may result in the Bureau’s taking action under applicable provisions of this section as it deems appropriate.
W. Va. Code R. § 64-109-21 Training
21.1. As required under the Act, the following individuals must complete a two-hour training course developed by the Bureau within the times specified:
21.1.1. Each principal of a medical cannabis organization, prior to starting initial operation of a facility.
21.1.2. Each employee of a medical cannabis organization who has direct contact with patients or caregivers or who physically handles medical cannabis, within 90 days after starting work at the facility.
21.2. The training course required under subsection 21.1 must provide the following information:
21.2.1. The provisions of the Act and legislative rules relevant to the responsibilities of principals and employees of grower/processors.
21.2.2. Proper handling of medical cannabis.
21.2.3. Proper recordkeeping.
21.2.4. How to prevent and detect the diversion of medical cannabis.
21.2.5. Best practice security procedures.
21.2.6. Best practice safety procedures, including responding to the following:
21.2.6.a. A medical emergency.
21.2.6.b. A fire.
21.2.6.c. A chemical spill.
21.2.6.d. A threatening event including:
21.2.6.d.1. An armed robbery.
21.2.6.d.2. A burglary.
21.2.6.d.3. A criminal incident.
21.3. A medical cannabis organization must retain the training attendance records of its principals and employees and make them available for inspection by the Bureau and its authorized agents upon request.
W. Va. Code R. § 64-109-22 Zoning
22.1. A grower/processor must meet the same municipal zoning and land use requirements as other manufacturing, processing, and production facilities that are located in the same zoning district.
22.2. A dispensary must meet the same municipal zoning and land use requirements as other commercial facilities that are located in the same zoning district.
W. Va. Code R. § 64-109-23 Advertising by a medical cannabis organization
23.1. In the advertising and marketing of medical cannabis, a medical cannabis organization must be consistent with the federal regulations governing prescription drug advertising and marketing in 21 C.F.R. § 202.1 (Prescription-drug advertisements).
23.2. Advertising Restrictions
23.2.1. Medical cannabis advertising may not:
23.2.1.a. Contain statements that are deceptive, false, or misleading;
23.2.1.b. Contain any content that can reasonably be considered to target individuals under the age of 21, including but not limited to images of minors, cartoons, toys, or similar images and items typically marketed towards minors, or references to products that are commonly associated with minors or marketed by minors;
23.2.1.c. Specifically encourages the transportation of medical cannabis items across state lines or otherwise encourages illegal activity;
23.2.1.d. Display consumption of medical cannabis items;
23.2.1.e. A medical cannabis organization may not make any deceptive, false, or misleading assertions or statements on any informational material, any sign, or any document provided to a consumer.
23.2.2. A medical cannabis organization must include the following statements on all print, billboard, television, radio, and internet advertising in font size legible to the viewer:
23.2.2.a. “Do not operate a vehicle or machinery under the influence of this drug."; and
23.2.2.b. “Keep out of the reach of children."
23.3. Advertising Media, Coupons, and Promotions.
23.3.1. Advertising through handbills that are passed out in public areas such as parking lots and publicly owned property is prohibited.
23.3.2. A medical cannabis organization may not utilize television, radio, billboards, print media, or internet advertising unless the medical cannabis organization has reliable evidence that no more than 30 percent of the audience for the program, publication, or internet web site in or on which the advertising is to air or appear is reasonably expected to be under the age of 21.
23.3.3. A medical cannabis organization that advertises via web page must utilize appropriate measures to ensure that individuals visiting the web page are over 21 years of age.
23.3.4. A medical cannabis organization may not engage in advertising via marketing directed towards location-based devices, including but not limited to cellular phones, unless the marketing is a mobile device application installed on the device by the owner of the device who is 21 years of age or older and includes a permanent and easy opt-out feature.
23.4. Removal of Objectionable and Non-Conforming Advertising.
23.4.1. A medical cannabis organization must remove any sign, display, or advertisement if the Bureau finds it violates these rules.
23.4.2. The Bureau will notify the medical cannabis organization and specify a reasonable time period for the medical cannabis organization to remove any sign, display, or advertisement that the Bureau finds objectionable.
23.5. Promotional, advertising, and marketing materials must be approved by the Bureau prior to their use.
23.6. This section does not apply to information provided by a grower/processor to a dispensary listing various medical cannabis items that the grower/processor is offering for sale to the dispensary.
W. Va. Code R. § 64-109-24 Technical advisories
24.1. The Bureau may issue technical advisories to assist permittees in complying with the Act and these rules. Technical advisories do not have the force of law or rule, but will provide guidance on the Bureau's interpretation of, and how a permittee may maintain compliance with, the Act and these rules. Notice of the availability of a technical advisory will be published in the State Register.
W. Va. Code R. § 64-109-25 Capital requirements
25.1. An applicant for a grower/processor permit must provide an affidavit that the applicant has at least $2,000,000 in capital, $500,000 of which must be on deposit with one or more financial institutions.
25.2. An applicant for a dispensary permit must provide an affidavit that the applicant has at least $150,000 on deposit with one or more financial institutions.
25.3. The affidavit must be in a form as prescribed by the Bureau.
25.4. An applicant must submit with the initial permit application a signed release allowing the Bureau to contact each financial institution listed in the application to verify the requirements of subsections 25.1 and 25.2.
W. Va. Code R. § 64-109-26 Administrative Due Process
26.1 Those persons adversely affected by the enforcement of this rule desiring a contested case hearing to determine any rights, duties, interests or privileges shall do so in accordance with 645CSR1, Rules of Procedure for Contested Case Hearings and Declaratory Rulings.
Series 110 Medical Cannabis Program - Grower/Processors
W. Va. Code R. § 64-110-1 General
1.1. Scope. This rule includes general provisions related to grower/processors pursuant to the West Virginia Medical Cannabis Act (W. Va. Code §16A-1-1 et seq.)
1.2. Authority. W. Va. Code §16A-3-1(b), §16A-7-3, and §16A-13-7.
1.3. Filing Date. May 8, 2025.
1.4. Effective Date. May 8, 2025.
1.5. Sunset Provision. This rule will terminate and have no further force or effect on August 1, 2030.
1.6. Applicability. This rule applies to a person or entity that desires to hold a permit as a medical cannabis organization in the state.
W. Va. Code R. § 64-110-2 Definitions
2.1. “Act” means the West Virginia Medical Cannabis Act (W. Va. Code §16A-1-1 et seq.)
2.2. “Adverse event” means an injury resulting from the use of medical cannabis dispensed at a dispensary. An injury includes physical harm, mental harm, or loss of function.
2.3. “Adverse loss” means a loss, discrepancy in inventory, or diversion or theft of seeds, immature medical cannabis plants, medical cannabis plants, medical cannabis, funds, or other property of a medical cannabis organization.
2.4. “Applicant” means a person who wishes to submit or submits an application to the Bureau for a permit to operate as a grower/processor or dispensary, or both, under the Act and this rule.
2.5. “Approved laboratory” means a laboratory that has applied for, and received, the approval of the Bureau to identify, collect, handle, and conduct tests on samples from a grower/processor and test samples from the Bureau used in the growing, processing, or dispensing of medical cannabis as required by the Act and this rule.
2.6. “Bureau” means the West Virginia Bureau for Public Health within the West Virginia Department of Health.
2.7. "Cannabis" means all parts of the plant of the genus cannabis, whether growing or not, the seeds thereof, the resin extracted from any part of the plant, and every compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds, or its resin, including cannabis concentrate. "Cannabis" does not include industrial hemp, nor does it include fiber produced from the stalks, oil, or cake made from the seeds of the plant, sterilized seed of the plant which is incapable of germination, or the weight of any other ingredient combined with cannabis to prepare topical or oral administrations, food, drink, or other product.
2.8. “CBD” means Cannabidiol.
2.9. “Caregiver” means the individual designated by a patient or, if the patient is under 18 years of age, and individual authorized under W. Va. Code §16A-5-1 et seq. to deliver medical cannabis.
2.10. “Certified medical use” means the acquisition, possession, use, or transportation of medical cannabis by a patient, or the acquisition, possession, delivery, transportation, or administration of medical cannabis by a caregiver, for use as part of the treatment of the patient's serious medical condition, as authorized in a patient certification issued under the Act, including enabling the patient to tolerate treatment for the serious medical condition.
2.11. “Clinical Registrant” means an entity that:
2.11.1. Holds a permit as both a grower/processor and a dispensary.
2.11.2. Has a contractual relationship with an academic clinical research center under which the academic clinical research center or its affiliate provides advice to the entity, regarding, among other areas, patient health and safety, medical applications and dispensing, and management of controlled substances.
2.12. “Controlled substance” means a drug, substance, or immediate precursor included in Schedules I though V of the Uniform Controlled Substance Act (W. Va. Code §60A-2-1 et seq.).
2.13. “Dispensary” means:
2.13.1. A person who holds a permit issued by the Bureau to dispense medical cannabis.
2.13.2. The term does not include a health care medical cannabis organization as defined by W. Va. Code §16A-13-1 et seq.
2.14. “Electronic tracking system” means an electronic seed-to-sale system prescribed by the Bureau that is implemented by:
2.14.1. A grower/processor to log, verify, and monitor the receipt, use, and sale of seeds, immature medical cannabis plants, or medical cannabis plants, the funds received by a grower/processor for the sale of medical cannabis to another medical cannabis organization, the disposal of medical cannabis waste, and the recall of defective medical cannabis;
2.14.2. A dispensary to log, verify, and monitor the receipt of medical cannabis product from a grower/processor, the verification of the validity of an identification card presented by a patient or caregiver, the dispensing of medical cannabis product to a patient or caregiver, the disposal of medical cannabis waste, and the recall of defective medical cannabis; and
2.14.3. An approved laboratory to log, verify, and monitor the receipt of samples and test samples for testing, the results of tests performed by the approved laboratory, and the disposal of tested and untested samples.
2.15. “Employee” means an individual who is hired for a wage, salary, fee, or payment to perform work for an applicant or permittee.
2.16. “Excipients” means solvents, chemicals, or materials reported by a medical cannabis organization and approved by the Bureau for use in the processing of medical cannabis.
2.17. “Facility” means a structure and other appurtenances or improvements where a medical cannabis organization grows and processes or dispenses medical cannabis.
2.18. “Financial backer” means an investor, mortgagee, bondholder, note holder, or other source of equity, capital, or other assets other than a financial institution.
2.19. “Form of medical cannabis” means the characteristics of the medical cannabis recommended or limited for a particular patient, including the method of consumption and any particular dosage, strain, variety, and quantity or percentage of medical cannabis, or particular active ingredient.
2.20. “Grower/processor” means:
2.20.1. A person who holds a permit from the Bureau under the Act to grow or process medical cannabis.
2.20.2. The term does not include a health care medical cannabis organization as defined under W. Va. Code §16A-13-1 et seq.
2.21. “Harvest batch” means a specifically identified quantity of medical cannabis plant that is uniform in strain, cultivated utilizing the same growing practices, harvested at the same time and at the same location, and cured under uniform conditions.
2.22. “Harvest lot” means a specifically identified quantity of medical cannabis plant taken from a harvest batch.
2.23. “Health care medical cannabis organization” means a vertically integrated health system approved by the Bureau to dispense medical cannabis or grow and process medical cannabis, or both, in accordance with a research study under W. Va. Code §16A-13-1 et seq.
2.24. “Hydroponic nutrient solution” means a mixture of water, minerals, and essential nutrients without soil used to grow medical cannabis plants.
2.25. “Identification card” means a document issued under W. Va. Code §16A-5-1 that authorizes access to medical cannabis under the Act.
2.26. “Immature medical cannabis plant” means a nonflowering part of a medical cannabis plant that is no taller than eight inches and no wider than eight inches produced from a cutting, clipping, or seedling and that is in a growing/cultivating container that is no larger than two inches wide and two inches tall that is sealed on the sides and bottom.
2.27. “Laboratory” means a place, establishment, or institution within the State of West Virginia that has been issued a certificate by the Bureau’s Office of Laboratory Services.
2.28. “Limited access area” means any area on a site or within a facility where:
2.28.1. Immature medical cannabis plants or seeds are stored, or medical cannabis plants are growing or being processed into medical cannabis;
2.28.2. Immature medical cannabis plants, medical cannabis plants, medical cannabis, or medical cannabis products are being loaded into or out of transport vehicles;
2.28.3. Medical cannabis is packaged for sale or stored;
2.28.4. Medical cannabis waste is processed, stored, or destroyed;
2.28.5. Surveillance system devices are stored.
2.29. “Medical cannabis” means cannabis that is grown and sold pursuant to the provisions for certified medical use as set forth in the Act and in a form set forth in the provisions 64CSR110-10 (Forms of medical cannabis).
2.30. “Medical cannabis container” means a sealed, traceable, food compliant, tamper resistant, tamper evident container used for the purpose of containment of packaged medical cannabis being transported from a grower/processor to a medical cannabis organization or a laboratory.
2.31. “Medical cannabis organization” means:
2.31.1. A dispensary or a grower/processor.
2.31.2. The term does not include a health care medical cannabis organization under sections W. Va. Code §16A-13-1 et seq. or a clinical registrant under W. Va. Code §16A-14-1 et seq.
2.32. “Medical cannabis plant” means a plant which is greater than eight vertical inches in height from where the base of the stalk emerges from the growth medium to the tallest point of the plant, or greater than eight horizontal inches in width from the end of one branch to the end of another branch.
2.33. “Medical cannabis program” means the program authorized under the Act and implemented by the Bureau.
2.34. “Medical cannabis waste” means:
2.34.1. Solid, liquid, semi-solid, or contained gaseous materials that are generated by a grower/processor or an approved laboratory.
2.34.2. The term includes:
2.34.2.a. Unused, surplus, returned, recalled, contaminated, or expired medical cannabis;
2.34.2.b. Any medical cannabis plant material that is not used in the growing, harvesting, or processing of medical cannabis, including flowers, stems, trim, leaves, seeds, dead medical cannabis plants, dead immature medical cannabis plants, unused medical cannabis plant parts, and unused immature medical cannabis plant parts or roots;
2.34.2.c. Spent hydroponic nutrient solution;
2.34.2.d. Unused containers for growing immature medical cannabis plants or medical cannabis plants or for use in the growing and processing of medical cannabis;
2.34.2.e. Unused fertilizers and pesticides;
2.34.2.f. Unused excipients; and
2.34.2.g. Wastewater.
2.35. “Municipality” means an incorporated city or town in this state.
2.36. “Nutrient” means the essential elements and compounds necessary for the growth, metabolism, and development of medical cannabis plants.
2.37. “Nutrient practice” means the use by a grower/processor of essential elements and compounds necessary for the growth, metabolism, and development of seeds, immature medical cannabis plants, or medical cannabis plants.
2.38. “Operational” means the time at which the Bureau determines that a medical cannabis organization is ready, willing, and able to properly carry on the activity for which a permit has been issued under this rule, including the implementation of an electronic tracking system.
2.39. “Operator” means an individual who directly oversees or manages the day-to-day business functions for an applicant or permittee and has the ability to direct employee activities onsite and offsite or within a facility for which a permit is sought or has been issued.
2.40. “Patient” means an individual who:
2.40.1. Has a serious medical condition;
2.40.2. Has met the requirements for certification under the Act; and
2.40.3. Is a resident of the State of West Virginia.
2.41. “Permit” means an authorization issued by the Bureau to an applicant to conduct activities authorized under the Act.
2.42. “Permittee” means a person who has been issued an authorization to operate as a medical cannabis organization under the Act and this rule.
2.43. “Person” means a natural person, corporation, foundation, organization, business trust, estate, limited liability company, licensed corporation, trust, partnership, limited liability partnership, association, or other form of legal business entity.
2.44. “Practitioner” means a physician who is registered with the Bureau under W. Va. Code §16A-4-1.
2.45. “Principal” means an officer, director, or person who directly or beneficially owns securities of an applicant or permittee, or a person who has a controlling interest in an applicant or permittee, or who has the ability to elect the majority of the board of directors of an applicant or permittee, or otherwise control an applicant or permittee, other than a financial institution.
2.46. “Processing” means the compounding or conversion of medical cannabis extract by a grower/processor into a medical cannabis product.
2.47. “Serious medical condition” means any of the following conditions:
2.47.1. Cancer;
2.47.2. Positive status for Human Immunodeficiency Virus or Acquired Immune Deficiency Syndrome;
2.47.3. Amyotrophic lateral sclerosis;
2.47.4. Parkinson's disease;
2.47.5. Multiple sclerosis;
2.47.6. Damage to the nervous tissue of the spinal cord with objective neurological indication of intractable spasticity;
2.47.7. Epilepsy;
2.47.8. Neuropathies;
2.47.9. Huntington's disease;
2.47.10. Crohn's disease;
2.47.11. Post-traumatic stress disorder;
2.47.12. Intractable seizures;
2.47.13. Sickle cell anemia;
2.47.14. Severe chronic or intractable pain of neuropathic origin, or severe chronic or intractable pain.; or
2.47.15. Terminally ill.
2.48. “Site” means the total area contained within the property line boundaries in which a facility is operated by a medical cannabis organization.
2.49. “Solid waste” means the term as defined in W. Va. Code §22-15-2 of the Solid Waste Management Act.
2.50. “Spent hydroponic nutrient solution” means hydroponic nutrient solution that has been used and can no longer serve the purpose for which it was produced.
2.51. “Terminally ill” means a medical prognosis of life expectancy of approximately one year or less if the illness runs its normal course.
2.52. “Sample” means medical cannabis collected by an employee of an approved laboratory from a grower/processor for testing by the laboratory.
2.53. “Test sample” means an amount of medical cannabis or an amount of soil, growing medium, water, or solvents used to grow or process medical cannabis, dust, or other particles obtained from the swab of a counter or equipment used in the growing or processing of medical cannabis, or other item used in the growing or processing of medical cannabis in a facility taken by an employee of an approved laboratory or an agent of the Bureau at the request of the Bureau from a grower/processor and provided to an approved laboratory for testing.
2.54. “THC” means Tetrahydrocannabinol.
2.55. “Transport vehicle” means a vehicle that meets the requirements of the Act and is used to transport medical cannabis between medical cannabis organizations or between medical cannabis organizations and a laboratory.
2.56. “Unit” means the weight or volume of total usable medical cannabis in the finished product, calculated in metric units.
W. Va. Code R. § 64-110-3 Growers/processors generally
3.1. The qualifications that a grower/processor must meet to receive a permit are continuing qualifications to maintain the permit.
3.2. In addition to any other requirements in the Act or this rule, a grower/processor must comply with the following:
3.2.1. A grower/processor may not engage in the business of growing, processing, possessing, selling, or offering to sell medical cannabis to another medical cannabis organization or to a clinical registrant within this state without first being issued a permit by the Bureau and without first being determined operational by the Bureau as required under 64CSR109-15 (Failure to be operational).
3.2.2. A grower/processor may not employ an individual at its facility who is under 18 years of age.
W. Va. Code R. § 64-110-4 Plans of operation
4.1. At the time the Bureau determines a grower/processor to be operational, the grower/processor must provide the Bureau with a full and complete plan of operation for review that includes the following:
4.1.1. Employment policies and procedures;
4.1.2. Security policies and protocols including:
4.1.2.a. Staff identification measures;
4.1.2.b. Monitoring of attendance of staff and visitors;
4.1.2.c. Alarm systems;
4.1.2.d. Video surveillance;
4.1.2.e. Monitoring and tracking inventory; and
4.1.2.f. Personal security.
4.1.3. A process for growing, receiving, processing, packaging, labeling, handling, tracking, transporting, storing, disposing, and recalling of medical cannabis and a process for handling, tracking, transporting, storing, and disposing of medical cannabis waste in accordance with applicable laws, rules, and regulations.
4.1.4. Workplace safety, including conducting necessary safety checks prior to starting the growing and processing of medical cannabis.
4.1.5. Contamination protocols.
4.1.6. Maintenance, cleaning, and sanitation of equipment in the facility or on the site, or both.
4.1.7. Maintenance and sanitation of the site or the facility, or both.
4.1.8. Proper handling and storage of any solvent, gas, or other chemical used in growing or processing medical cannabis in accordance with this rule and other applicable laws, rules, and regulations.
4.1.9. Quality control, including regulation of the amount of THC in each process lot, proper labeling, and minimization of medical cannabis contamination.
4.1.10. Inventory maintenance and reporting procedures.
4.1.11. The investigation of complaints and potential adverse events from other medical cannabis organizations, patients, caregivers, or practitioners regarding the operation of the grower/processor.
4.1.12. A recall plan meeting the requirements of section 23 (Complaints about or recall of medical cannabis).
4.2. A grower/processor must make the full and complete plan of operation available to the Bureau upon request and during any inspection of the site and facility.
W. Va. Code R. § 64-110-5 Grower/processor facilities
5.1. A grower/processor may only grow, store, harvest, or process medical cannabis in an indoor, enclosed, secure facility as approved by the Bureau.
5.2. The following areas of a facility must be clearly marked with proper signage:
5.2.1. Medical cannabis growing and processing areas. These areas must be easily observed by the Bureau and its authorized agents and by law enforcement.
5.2.2. Nongrowing and non-processing areas.
5.2.3. Limited access areas. All areas of ingress and egress to a limited access area must be clearly identified by the posting of a sign which must be not less than 12 inches wide and 12 inches long, composed of letters not less than one-half inch in height, which must state: “Do Not Enter—Limited Access Area—Access Limited to Authorized Personnel and Escorted Visitors.”
5.2.4. Areas that include business offices and reception rooms.
5.3. A facility must have an enclosed secure area out of public sight for the loading and unloading of medical cannabis into and from a transport vehicle.
W. Va. Code R. § 64-110-6 Start-up inventory
6.1. A grower/processor may obtain seeds or immature medical cannabis plants from outside of this state for the purpose of securing its start-up inventory. Seeds or immature medical cannabis plants obtained from outside this state must be obtained within 30 days from the date that the Bureau determines that the grower/processor is operational.
6.2. Except as provided by subsection 6.1, a grower/processor may not obtain medical cannabis seeds or plants from outside of this state at any time without first obtaining express, written permission from the Bureau.
6.3. A grower/processor must, within 24 hours of receipt, record in the electronic tracking system each seed and immature medical cannabis plant that enters the site during the 30-day period set forth in subsection 6.1.
6.4. After the 30-day period set forth in subsection 6.1, a grower/processor must only grow medical cannabis plants from seeds or immature medical cannabis plants located physically in its facility, or purchase seeds, immature medical cannabis plants, or medical cannabis plants from another grower/processor unless granted permission to obtain seeds or plants from outside the state as set forth in subsection 6.2.
W. Va. Code R. § 64-110-7 Visitor access to grower/processor facilities
7.1. A grower/processor facility may not be open to the general public. A grower/processor must require visitors, including vendors, contractors, and other individuals requiring access to the facility for purposes regarding the growing, processing, or testing of medical cannabis, to sign a visitor log and wear a visitor identification badge that is visible to others at all times while on the site and in the facility.
7.2. A grower/processor must require visitors to present valid government-issued identification that contains a photo to gain access to the site and facility.
7.3. No one under 18 years of age is permitted to enter a grower/processor site and facility.
7.4. A grower/processor must post a sign in a conspicuous location at each entrance of the site and facility that states: “THESE PREMISES ARE UNDER CONSTANT VIDEO SURVEILLANCE. NO ONE UNDER THE AGE OF 18 IS PERMITTED TO ENTER.”
7.5. A grower/processor must do all of the following when admitting a visitor to its site and facility:
7.5.1. Require the visitor to sign a visitor log upon entering and leaving the facility.
7.5.2. Check the visitor's government-issued identification to verify that the name on the identification provided matches the name in the visitor log. A photocopy of the identification must be retained with the log.
7.5.3. Issue a visitor identification badge with the visitor's name and company, if applicable, and a badge number.
7.5.4. Escort the visitor while the visitor remains in the facility or on the site.
7.5.5. Ensure that the visitor does not touch any medical cannabis plant or medical cannabis located in a limited access area.
7.6. The following apply to the visitor log required under subsections 7.1 and 7.5:
7.6.1. The grower/processor must maintain the log for four years and make the log available to the Bureau, law enforcement, and other federal or state government officials upon request, if necessary to perform the government officials' functions and duties.
7.6.2. The log must include the full name of each visitor, the visitor identification badge number, the time of arrival, the time of departure, and the purpose of the visit, including the areas of the site and the facility visited and the name of each employee visited.
7.7. This section does not limit the right of the Bureau or its authorized agents, or other federal or state government officials, from entering any area of a grower/processor site and facility, if necessary to perform the governmental officials' functions and duties.
7.8. A principal, financial backer, operator, or an employee of a grower/processor may not receive any type of consideration or compensation for allowing a visitor to enter a limited access area.
W. Va. Code R. § 64-110-8 Security and surveillance
8.1. A grower/processor must have security and surveillance systems, utilizing commercial-grade equipment, to prevent unauthorized entry and to prevent and detect an adverse loss. The security and surveillance systems must include the following:
8.1.1. A professionally monitored security alarm system that includes the following:
8.1.1.a. Coverage of all facility entrances and exits; rooms with exterior windows, exterior walls, and roof hatches or skylights; storage rooms, including those that contain medical cannabis and safes; and the perimeter of the facility;
8.1.1.b. A silent security alarm system signal, known as a duress alarm, generated by the entry of a designated code into an arming station to signal that the alarm user is being forced to turn off the system;
8.1.1.c. An audible security alarm system signal, known as a panic alarm, generated by the manual activation of a device intended to signal a life-threatening or emergency situation requiring law enforcement response;
8.1.1.d. A silent alarm signal, known as a holdup alarm, generated by the manual activation of a device intended to signal a robbery in progress;
8.1.1.e. An electrical, electronic, mechanical, or other device capable of being programmed to send a prerecorded voice message requesting dispatch, when activated, over a telephone line, radio, or other communication system to a law enforcement, public safety, or emergency services agency;
8.1.1.f. A failure notification system that provides an audible, text, or visual notification of any failure in the systems. The failure notification system must provide by telephone, e-mail, or text message an alert to a designated security person within the facility within five minutes after the failure;
8.1.1.g. Smoke and fire alarms
8.1.1.h. Auxiliary power sufficient to maintain operation of specified growing and processing areas identified in the grower/processor's plan of operation for at least 48 hours following a power outage;
8.1.1.i. The ability to ensure all access doors are not solely controlled by an electronic access panel to prevent locks from becoming released during a power outage; and
8.1.1.j. Motion detectors; and
8.1.2. A professionally monitored security and surveillance system that is operational 24 hours a day, seven days a week, and records all activity in images capable of clearly revealing facial detail. The security and surveillance system must include the following:
8.1.2.a. Fixed camera placement that allows for a clear image of all individuals and activities in and around the following:
8.1.2.a.1. All limited access areas;
8.1.2.a.2. A room or area containing a security and surveillance system storage device or equipment;
8.1.2.a.3. Entrances to and exits from the facility. Entrances and exits must be recorded from both indoor and outdoor vantage points;
8.1.2.a.4. Rooms with exterior windows, exterior walls, roof hatches or skylights, and storage rooms, including those that may contain medical cannabis and safes; and
8.1.2.a.5. Twenty feet from the exterior of the perimeter of the facility;
8.1.2.b. Auxiliary power sufficient to maintain operation for at least 48 hours following a power outage;
8.1.2.c. Ability to operate under the normal lighting conditions of each area under surveillance;
8.1.2.d. Ability to immediately produce a clear, color, still photograph in a digital format that meets the requirements of this subsection;
8.1.3. Ability to clearly and accurately display the date and time. The date and time must be synchronized and set correctly and may not significantly obscure the picture;
8.1.4. Ability to record all images captured by each surveillance camera in a format that may be easily accessed for a period not less than 180 days, unless otherwise required for investigative or litigation purposes as described in paragraph 8.2.6.b. The recordings must be kept:
8.1.4.a. At the facility:
8.1.4.a.1. In a locked cabinet, closet, or other secure place to protect it from tampering or theft; and
8.1.4.a.2. In a limited access area or other room to which access is limited to authorized individuals; or
8.1.4.b. At a secure location other than the location of the facility if approved by the Bureau; and
8.1.5. A security alarm system separate from the facility's primary security system covering the limited access area or other room where the recordings under subdivision 8.1.4. are stored. The separate security alarm system must meet the same requirements as the facility's primary security alarm system.
8.2. The following apply regarding the inspection, servicing, or alteration of, and the upgrade to, the site's and facility's security and surveillance systems:
8.2.1. The systems must be inspected, and all devices tested once every year by a qualified alarm system vendor and a qualified surveillance system vendor, as approved by the Bureau;
8.2.2. The grower/processor must conduct maintenance inspections once every month to ensure that any repairs, alterations, or upgrades to the security and surveillance systems are made for the proper operation of the systems;
8.2.3. The grower/processor must retain at the facility, for at least four years, records of all inspections, servicing, alterations, and upgrades performed on the systems and must make the records available to the Bureau and its authorized agents within two business days following a request;
8.2.4. In the event of a mechanical malfunction of the security or surveillance system that a grower/processor anticipates will exceed an eight-hour period, the grower/processor must notify the Bureau immediately and, with Bureau approval, provide alternative security measures that may include closure of the facility;
8.2.5. The grower/processor must designate an employee to continuously monitor the security and surveillance systems at the facility; and
8.2.6. The following apply regarding records retention:
8.2.6.a. Within two business days following a request, a grower/processor must provide screen captures of an unaltered copy of a video surveillance recording to the Bureau or its authorized agents, law enforcement, or other federal or state government officials, if necessary to perform the governmental officials' functions and duties; and
8.2.6.b. If a grower/processor has been notified in writing by the Bureau or its authorized agents, law enforcement, or other federal or state government officials of a pending criminal or administrative investigation for which a recording may contain relevant information, the grower/processor must retain an unaltered copy of the recording for two years or until the investigation or proceeding is closed or the entity conducting the investigation or proceeding notifies the grower/processor that it is not necessary to retain the recording, whichever is longer.
8.3. The grower/processor must install commercial-grade, nonresidential doors and door locks on each external door of the facility. Keys or key codes for all doors must remain in the possession of designated authorized individuals.
8.4. During all nonworking hours, all entrances to and exits from the site and facility must be securely locked.
8.5. The grower/processor must have an electronic back-up system for all electronic records.
8.6. The grower/processor must install lighting to ensure proper surveillance inside and outside of the facility.
8.7. A grower/processor must limit access to a room containing security and surveillance monitoring equipment to persons who are essential to maintaining security and surveillance operations; federal, state, and local law enforcement; security and surveillance system service employees; the Bureau or its authorized agents; and other persons with the prior written approval of the Bureau. The following apply:
8.7.1. A grower/processor must make available to the Bureau or the Bureau's authorized agents, upon request, a current list of authorized employees and service employees or contractors who have access to any security and surveillance areas; and
8.7.2. A grower/processor must keep security and surveillance rooms locked at all times and may not use these rooms for any other purpose or function.
W. Va. Code R. § 64-110-9 Requirements for growing and processing medical cannabis
9.1. A grower/processor must use only pesticides, fungicides, or herbicides that are approved by the United States Department of Agriculture for use on medical cannabis plants and listed in Appendix A (Acceptable pesticide active ingredients for use). The Bureau will periodically publish a notice in the State Register updating the list of pesticides, fungicides, or herbicides.
9.2. A grower/processor must use the pesticides, fungicides, or herbicides listed in Appendix A in a manner that is approved by the United States Department of Agriculture on the basis of federal law and regulations.
9.3. A grower/processor must maintain a log of all actions taken to detect pests or pathogens, and the measures taken for control.
9.4. A grower/processor must:
9.4.1. Use appropriate nutrient practices;
9.4.2. Use a fertilizer or hydroponic solution of a type, formulation, and at a rate to support healthy growth of plants; and
9.4.3. Maintain records of the type and amounts of fertilizer and any growth additives used.
9.5. A grower/processor must perform visual inspections of growing plants and harvested plant material to ensure there is no visible mold, mildew, pests, rot, or grey or black plant material that is greater than an acceptable level as determined by the Bureau.
9.6. A grower/processor may not add any additional active ingredients or materials to medical cannabis that alters the color, appearance, smell, taste, effect, or weight of the medical cannabis unless the grower/processor has first obtained the prior written approval of the Bureau. Excipients must be pharmaceutical grade, unless otherwise approved by the Bureau.
9.7. A grower/processor must have a separate and secure area for temporary storage of medical cannabis that is awaiting disposal by the grower/processor.
9.8. A grower/processor must only process the parts of the medical cannabis plant that:
9.8.1. Are free of seeds and stems;
9.8.2. Are free of dirt, sand, debris, or other foreign matter; and
9.8.3. Contain a level of mold, rot, or other fungus or bacterial diseases acceptable to the Bureau.
9.9. A grower/processor must process the medical cannabis plants in a safe and sanitary manner. The following apply:
9.9.1. Medical cannabis, raw material, and other product used in the processing of medical cannabis must be handled on food-grade stainless steel benches or tables;
9.9.2. Proper sanitation must be maintained; and
9.9.3. Proper rodent, bird, and pest exclusion practices must be employed.
9.10. A grower/processor must install a system to monitor, record, and regulate:
9.10.1. Temperature;
9.10.2. Humidity;
9.10.3. Ventilation;
9.10.4. Lighting; and
9.10.5. Water supply.
W. Va. Code R. § 64-110-10 Forms of medical cannabis
10.1. A grower/processor may only process medical cannabis for dispensing to a patient or caregiver in the following forms:
10.1.1. Pill;
10.1.2. Oil;
10.1.3. Topical forms, including gel, creams, and ointments;
10.1.4. A form medically appropriate for administration by vaporization or nebulization;
10.1.5. Liquid;
10.1.6. Dermal patch; or
10.1.7. Dry leaf or plant form.
10.2. A grower/processor may not manufacture, produce, or assemble any medical cannabis product, instrument, or device without prior written approval of the Bureau.
W. Va. Code R. § 64-110-11 Limit on medical cannabis processing
11.1. In the form intended to be sold to another medical cannabis organization, medical cannabis must have a specific concentration of total THC and total CBD and must have a consistent cannabinoid profile. The concentration of the following cannabinoids, at a minimum, must be reported to the Bureau by an approved laboratory and include the following on the label:
11.1.1. Tetrahydrocannabinol (THC);
11.1.2. Tetrahydrocannabinol acid (THCA);
11.1.3. Tetrahydrocannabivarin (THCV);
11.1.4. Cannabidiol (CBD);
11.1.5. Cannabinadiolic acid (CBDA);
11.1.6. Cannabidivarine (CBDV);
11.1.7. Cannabinol (CBN);
11.1.8. Cannabigerol (CBG);
11.1.9. Cannabichromene (CBC); and
11.1.10. Any other cannabinoid component at > 0.1percent.
11.2. Within the first six months after the Bureau determines the grower/processor to be operational, the grower/processor must provide the Bureau with a forecast of the amount of medical cannabis it projects it will produce and in what form. The grower/processor must notify the Bureau in writing immediately upon becoming aware of a potential increase or decrease in the forecasted amount occurring within any subsequent six-month period.
W. Va. Code R. § 64-110-12 Inventory data
12.1. A grower/processor must maintain the following inventory data in its electronic tracking system which must include an accounting of and an identifying tracking number for:
12.1.1. The number, weight, and type of seeds;
12.1.2. The number of immature medical cannabis plants;
12.1.3. The number of medical cannabis plants;
12.1.4. The number of medical cannabis products ready for sale; and
12.1.5. The number of damaged, defective, expired, or contaminated seeds, immature medical cannabis plants, medical cannabis plants, and medical cannabis products awaiting disposal.
12.2. A grower/processor must establish inventory controls and procedures to conduct inventory reviews and comprehensive inventories at its facility. The following apply:
12.2.1. Inventory reviews of medical cannabis plants in the process of growing, medical cannabis, and medical cannabis products that are being stored for future sale must be conducted monthly;
12.2.2. Comprehensive inventories of seeds, immature medical cannabis plants, medical cannabis plants, medical cannabis, and medical cannabis products must be conducted at least annually; and
12.3. A written or electronic record must be created and maintained of each inventory conducted under subsection 12.2. that includes the date of the inventory, a summary of the inventory findings, and the employee identification numbers and titles or positions of the individuals who conducted the inventory.
W. Va. Code R. § 64-110-13 Equipment, operation, and maintenance
13.1. A grower/processor facility must have a written process in place to maintain the sanitation and operation of equipment that comes into contact with medical cannabis to prevent contamination. The grower/processor must provide a copy of the written process to the Bureau upon request.
13.2. As part of the written process required under subsection 13.1., a grower/processor must:
13.2.1. Routinely calibrate, check, and inspect the following to ensure accuracy:
13.2.1.a. Automatic, mechanical, or electronic equipment;
13.2.1.b. Scales, balances, or other measurement devices used in the grower/processor’s operations; and
13.2.2. Maintain an accurate log recording the following:
13.2.2.a. Maintenance of equipment;
13.2.2.b. Cleaning of equipment; and
13.2.2.c. Calibration of equipment.
W. Va. Code R. § 64-110-14 Storage requirements
14.1. A grower/processor must have separate locked limited access areas for storage of seeds, immature medical cannabis plants, medical cannabis plants, and medical cannabis that are expired, damaged, deteriorated, mislabeled, contaminated, recalled, or whose containers or packaging have been opened or breached until the seeds, immature medical cannabis plants, medical cannabis plants, and medical cannabis are destroyed or otherwise disposed of as required under section 22 (Management and disposal of medical cannabis waste).
14.2. A grower/processor must maintain all storage areas in a clean and orderly condition and free from infestation by insects, rodents, birds, and pests.
W. Va. Code R. § 64-110-15 Sanitation and safety in a facility
15.1. A grower/processor must maintain its facility in a sanitary condition to limit the potential for contamination or adulteration of the medical cannabis grown and processed in the facility. The following apply:
15.1.1. Equipment and surfaces, including floors, counters, walls, and ceilings, must be cleaned and sanitized as frequently as necessary to protect against contamination, using a sanitizing agent registered by the United States Environmental Protection Agency, in accordance with the instructions printed on the label. Equipment and utensils must be so designed and of such material and workmanship as to be capable of being adequately cleaned.
15.1.2. Trash must be properly removed.
15.1.3. Floors, walls, and ceilings must be kept in good repair.
15.1.4. Equipment, counters, and surfaces for processing must be food grade quality and may not react adversely with any solvent being used.
15.1.5. Adequate protection against pests must be provided through the use of integrated pest management practices and techniques that identify and manage plant pathogens and pest problems, and the regular disposal of trash to prevent infestation.
15.1.6. Toxic cleaning compounds, sanitizing agents, solvents used in the growing and processing of medical cannabis, and pesticide chemicals must be labeled and stored in a manner that prevents contamination of seeds, immature medical cannabis plants, medical cannabis plants, and medical cannabis, and in a manner that otherwise complies with other applicable laws, rules, and regulations.
15.2. An employee must conform to sanitary practices while on duty, including the following:
15.2.1. Maintaining adequate personal hygiene;
15.2.2. Wearing proper clothing, including gloves; and
15.2.3. Washing hands thoroughly in an adequate hand-washing area before starting work and at any other time when hands may have become soiled or contaminated.
15.3. A grower/processor must provide its employees and visitors with adequate and convenient hand-washing facilities furnished with running water at a temperature suitable for sanitizing hands. The following apply:
15.3.1. Hand-washing facilities must be located in processing areas and where good sanitary practices require employees to wash and sanitize their hands; and
15.3.2. Effective nontoxic sanitizing cleansers and sanitary towel service or suitable drying devices must be provided.
15.4. A grower/processor must provide its employees and visitors with adequate, readily accessible lavatories that are maintained in a sanitary condition and in good repair.
15.5. A grower/processor must ensure that its facility is provided with a water supply sufficient for its operations, which must be derived from a source that is a public water system, or a nonpublic system that is capable of providing a safe, potable, and adequate supply of water to meet the operational needs of the facility.
15.6. A grower/processor must comply with all other applicable state and local building code requirements.
W. Va. Code R. § 64-110-16 Packaging and labeling of medical cannabis
16.1. A grower/processor must package and label at its facility each form of medical cannabis prepared for sale. The original seal of a package may not be broken, except for quality control testing at an approved laboratory, for adverse loss investigations conducted by the Bureau, or by a dispensary that purchased the medical cannabis.
16.2. A grower/processor must package the medical cannabis in a package that minimizes exposure to oxygen and that is:
16.2.1. Child-resistant;
16.2.2. Tamper-proof or tamper-evident;
16.2.3. Light-resistant and opaque; and
16.2.4. Resealable.
16.3. A grower/processor must identify each process lot of medical cannabis with a unique identifier.
16.4. A grower/processor must obtain the prior written approval of the Bureau of the content of any label to be affixed to a medical cannabis package. Each label must:
16.4.1. Be easily readable;
16.4.2. Be Made of weather-resistant and tamper-resistant materials;
16.4.3. Be conspicuously placed on the package;
16.4.4. Include the name, address, and permit number of the grower/processor;
16.4.5. List the form, quantity, and weight of medical cannabis included in the package;
16.4.6. List the number of individual doses contained within the package, and the species and percentage of THC and CBD;
16.4.7. Contain an identifier that is unique to a particular harvest batch of medical cannabis, including the number assigned to each harvest lot or process lot in the harvest batch;
16.4.8. Include the date the medical cannabis was packaged;
16.4.9. State the employee identification number of the employee preparing the package and packaging the medical cannabis;
16.4.10. State the employee identification number of the employee shipping the package, if different than the employee described in subdivision 16.4.9.;
16.4.11. Contain the name and address of the dispensary to which the package is to be sold;
16.4.12. List the date of expiration of the medical cannabis;
16.4.13. Include instructions for proper storage of the medical cannabis in the package;
16.4.14. Contain the following warning stating: “This product is for medicinal use only. Women should not consume during pregnancy or while breastfeeding except on the advice of the practitioner who issued the certification and, in the case of breastfeeding, the infant's pediatrician. This product might impair the ability to drive or operate heavy machinery. Keep out of reach of children.”;
16.4.15. Contain a warning that the medical cannabis must be kept in the original container in which it was dispensed; and
16.4.16. Contain a warning that unauthorized use is unlawful and will subject the purchaser to criminal penalties.
16.5. Labeling by a grower/processor of any medical cannabis may not bear:
16.5.1. Any resemblance to the trademarked, characteristic, or product-specialized packaging of any commercially available food or beverage product;
16.5.2. Any statement, artwork, or design that could reasonably lead an individual to believe that the package contains anything other than medical cannabis;
16.5.3. Any seal, flag, crest, coat of arms, or other insignia that could reasonably mislead an individual to believe that the product has been endorsed, manufactured, or approved for use by any state, county, or municipality or any agency thereof; or
16.5.4. Any cartoon, color scheme, image, graphic, or feature that might make the package attractive to children.
W. Va. Code R. § 64-110-17 Transportation of medical cannabis
17.1. A grower/processor may transport and deliver medical cannabis to a medical cannabis organization or an approved laboratory in this state in accordance with this section. The following apply:
17.1.1. A grower/processor may deliver medical cannabis to a medical cannabis organization or an approved laboratory only between 7:00 a.m. and 9:00 p.m.;
17.1.2. A grower/processor may contract with a third-party contractor for delivery so long as the contractor complies with this section;
17.1.3. A grower/processor may not transport medical cannabis to any location outside of this state; and
17.1.4. A grower/processor must use a global positioning system to ensure safe, efficient delivery of the medical cannabis to a medical cannabis organization or an approved laboratory.
17.2. Vehicles permitted to transport medical cannabis must:
17.2.1. Be equipped with a secure lockbox or locking cargo area;
17.2.2. Have no markings that would either identify or indicate that the vehicle is being used to transport medical cannabis;
17.2.3. Be capable of being temperature-controlled for perishable medical cannabis, as appropriate;
17.2.4. Display current state inspection stickers and maintain a current state vehicle registration; and
17.2.5. Be insured in an amount that is commercially reasonable and appropriate.
17.3. A transport vehicle must be staffed with a delivery team consisting of at least two individuals and comply with the following:
17.3.1. At least one delivery team member must remain with the vehicle at all times that the vehicle contains medical cannabis;
17.3.2. Each delivery team member must have access to a secure form of communication with the grower/processor, such as a cellular telephone, at all times that the vehicle contains medical cannabis;
17.3.3. Each delivery team member must carry an identification badge or card at all times and must, upon demand, produce it to the Bureau or its authorized agents, law enforcement, or other federal or state government officials, if necessary, to perform the government officials' functions and duties;
17.3.4. Each delivery team member must have a valid driver's license; and
17.3.5. While on duty, a delivery team member may not wear any clothing or symbols that may indicate ownership or possession of medical cannabis.
17.4. Medical cannabis stored inside the transport vehicle may not be visible from the outside of the transport vehicle.
17.5. Except as provided in subsection 17.8., a delivery team shall proceed in a transport vehicle from the facility, where the medical cannabis is loaded, directly to the medical cannabis organization or approved laboratory, where the medical cannabis is unloaded, without unnecessary delays. Notwithstanding the foregoing, a transport vehicle may make stops at multiple facilities or approved laboratories, as appropriate, to deliver medical cannabis.
17.6. A grower/processor must immediately report to the Bureau, either through a designated phone line established by the Bureau or by electronic communication with the Bureau in a manner prescribed by the Bureau, vehicle accidents, diversions, losses, or other reportable events that occur during transport of medical cannabis.
17.7. A grower/processor must notify the Bureau daily of its delivery schedule, including routes and delivery times, either through a designated phone line established by the Bureau or by electronic communication with the Bureau in a manner prescribed by the Bureau.
17.8. A transport vehicle is subject to inspection by the Bureau or its authorized agents, law enforcement, or other federal or state government officials if necessary, to perform the government officials' functions and duties. A transport vehicle may be stopped and inspected along its delivery route or at any medical cannabis organization or approved laboratory.
W. Va. Code R. § 64-110-18 Transport manifest
18.1. A grower/processor must generate a printed or electronic transport manifest that accompanies every transport vehicle and contains the following information:
18.1.1. The name, address, and permit number of the grower/processor and the name of and contact information for a representative of the grower/processor who has direct knowledge of the transport;
18.1.2. The name, address, and permit number of the medical cannabis organization or approved laboratory receiving the delivery and the name of and contact information for a representative of the medical cannabis organization or approved laboratory;
18.1.3. The quantity, by weight or unit, of each medical cannabis harvest batch, harvest lot, or process lot contained in the transport, along with the identification number for each batch or lot;
18.1.4. The date and approximate time of departure;
18.1.5. The date and approximate time of arrival;
18.1.6. The transport vehicle's make and model and license plate number; and
18.1.7. The identification number of each member of the delivery team accompanying the transport.
18.2. When a delivery team delivers medical cannabis to multiple medical cannabis organizations or approved laboratories, the transport manifest must correctly reflect the specific medical cannabis in transit. Each recipient must provide the grower/processor with a printed receipt for the medical cannabis received.
18.3. All medical cannabis being transported must be packaged in shipping containers and labeled in accordance with section 16 (Packaging and labeling of medical cannabis).
18.4. A grower/processor must provide a copy of the transport manifest to the recipient receiving the medical cannabis described in the transport manifest. To maintain confidentiality, a grower/processor may prepare separate manifests for each recipient.
18.5. A grower/processor must, if requested, provide a copy of the printed transport manifest, and any printed receipts for medical cannabis being transported, to the Bureau or its authorized agents, law enforcement, or other federal or state government officials, if necessary to perform the government officials' functions and duties.
W. Va. Code R. § 64-110-19 Transportation of seeds, immature medical cannabis plants, and medical cannabis plants
19.1. A grower/processor may transport seeds, immature medical cannabis plants, and medical cannabis plants within this state for the growing and processing of medical cannabis.
19.2. A grower/processor may not transport seeds, immature medical cannabis plants, or medical cannabis plants to a location outside of this state.
19.3. A grower/processor's authorization to transport seeds, immature medical cannabis plants, or medical cannabis plants are subject to the requirements of sections 17, 18, and 20 (Transportation of medical cannabis; Transport manifest; and Evidence of adverse loss during transport).
W. Va. Code R. § 64-110-20 Evidence of adverse loss during transport
20.1. If a grower/processor receiving a delivery of medical cannabis or medical cannabis products from a medical cannabis organization discovers a discrepancy in the transport manifest upon delivery, the grower/processor must refuse acceptance of the delivery and immediately report the discrepancy to the Bureau either through a designated phone line established by the Bureau or by electronic communication with the Bureau in a manner prescribed by the Bureau, and to the appropriate law enforcement authorities.
20.2. If a grower/processor discovers evidence of, or reasonably suspects, a theft, or diversion of medical cannabis or medical cannabis products during transport, the grower/processor must immediately report its findings or suspicions to the Bureau either through a designated phone line established by the Bureau or by electronic communication with the Bureau in a manner prescribed by the Bureau and to law enforcement.
20.3. If a grower/processor discovers a discrepancy in the transport manifest, the grower/processor must:
20.3.1. Conduct an investigation;
20.3.2. Amend the grower/processor's standard plan of operation, if necessary, to prevent future discrepancies between the quantity or description of inventory listed in the transport manifest and the quantity or description of inventory delivered; and
20.3.3. Submit a report of the investigation to the Bureau. The following apply:
20.3.3.a. A written preliminary report of the investigation must be submitted to the Bureau within seven days of discovering the discrepancy; and
20.3.3.b. A final written report of the investigation must be submitted to the Bureau within 30 days of discovering the discrepancy.
W. Va. Code R. § 64-110-21 Electronic tracking system
21.1. A grower/processor must use the electronic tracking system prescribed by the Bureau containing the requirements in W. Va. Code §16A-7-1. The Bureau will publish notice of the electronic tracking system to be utilized by a grower/processor in the State Register 60 days prior to the implementation date of the system.
W. Va. Code R. § 64-110-22 Management and disposal of medical cannabis waste
22.1. Medical cannabis waste generated by a grower/processor or an approved laboratory must be stored, collected, and transported in accordance with W. Va. Code §22-15-1 et seq. (Solid Waste Management Act), provided the medical cannabis waste is not hazardous.
22.2. The following types of medical cannabis waste must be rendered unusable and unrecognizable prior to being transported from a grower/processor or an approved laboratory:
22.2.1. Unused, surplus, returned, recalled, contaminated, or expired medical cannabis; and
22.2.2. Any medical cannabis plant material that is not used in the growing, harvesting, or processing of medical cannabis, including flowers, stems, trim, leaves, seeds, dead medical cannabis plants, dead immature medical cannabis plants, unused medical cannabis plant parts, and unused immature medical cannabis plant parts or roots.
22.3. Medical cannabis waste is unusable and unrecognizable if all components of the waste are indistinguishable and incapable of being ingested, inhaled, injected, swallowed, or otherwise used for certified medical use. Acceptable methods of rendering the waste unusable and unrecognizable include thermal treatment or melting; shredding, grinding, or tearing; and incorporating the medical cannabis waste with other municipal waste.
22.4. Unusable and unrecognizable medical cannabis waste identified in subsection 22.2. and other solid or semi-solid medical cannabis waste that is not hazardous must be disposed of at a permitted municipal waste landfill or processed at a permitted resource recovery facility or incinerator.
22.5. Wastewater or spent hydroponic nutrient solution generated or produced from the growing, harvesting, or processing of immature medical cannabis plants or medical cannabis plants must be managed in accordance with one of the following:
22.5.1. Discharged into a permitted sewage treatment system in accordance with local, federal, and state requirements, including the Water Pollution Control Act (W. Va. Code §22-11-1 et seq.);
22.5.2. Treated and discharged into waters of the state under a National Pollutant Discharge Elimination System permit or water quality management permit in accordance with local, federal, and state requirements, including the Water Pollution Control Act (W. Va. Code §22-11-1 et seq.); and
22.5.3. Disposed in a solid waste landfill if placed in a container that is less than one gallon in size.
22.6. Hazardous waste must be managed in accordance with federal and state law, rules, and regulations related to hazardous waste, including sections 3001—3024 of the Resource Conservation and Recovery Act of 1976 (42 U.S.C.A. §§ 6921—6939g), the Hazardous Waste Management Act (W. Va. Code §22-18-1 et seq.) and rules promulgated thereunder.
22.7. The type of medical cannabis waste identified in subdivision 22.2.2. may be composted and beneficially used at the grower/processor facility through a permit provided the requirements of 33CSR3 (Yard Waste Composting Rule) are satisfied, and the compost is beneficially used at the grower/processor facility as a soil substitute, soil conditioner, soil amendment, fertilizer, or mulch.
W. Va. Code R. § 64-110-23 Complaints about or recall of medical cannabis
23.1. A dispensary shall notify the Bureau and the grower/processor immediately upon becoming aware of any complaint made to the dispensary by a patient, caregiver, or practitioner who reports an adverse event from using medical cannabis purchased by the dispensary from the grower/processor. A grower/processor must investigate the report. The following apply:
23.1.1. A grower/processor must investigate a complaint to determine if a voluntary or mandatory recall of medical cannabis is necessary or if any further action is required; and
23.1.2. If a grower/processor determines that further action is not required, the grower/processor must notify the Bureau of its decision and, within 24 hours, submit a written report to the Bureau stating its rationale for not taking further action.
23.2. The following apply to voluntary recalls:
23.2.1. A grower/processor may voluntarily recall medical cannabis from the market at its discretion for reasons that do not pose a risk to public health and safety; and
23.2.2. If a grower/processor initiates a recall for a reason that does not pose a risk to public health and safety, the grower/processor must notify the Bureau at the time the grower/processor begins the recall.
23.3. The following apply to mandatory recalls:
23.3.1. If a grower/processor discovers that a condition relating to the medical cannabis grown or processed at its facility poses a risk to public health and safety, the grower/processor must:
23.3.1.a. Immediately notify the Bureau by phone; and
23.3.1.b. Secure, isolate, and prevent the distribution of the medical cannabis that may have been affected by the condition and remains in its possession. The grower/processor may not dispose of affected medical cannabis prior to notifying the Bureau and coordinating the disposal with the Bureau.
23.3.2. If a grower/processor fails to cooperate with the Bureau in a recall, or fails to immediately notify the Bureau of a need for a recall under subsection 23.1, the Bureau may issue a cease and desist order under 64CSR109-20 (General penalties and sanctions) and the grower/processor may be subject to any other penalties or sanctions provided for in the Act or this rule.
23.4. A grower/processor's recall plan must include the following:
23.4.1. Designation of one or more employees to serve as the recall coordinators. A recall coordinator must be responsible for, among other duties, accepting the recalled medical cannabis;
23.4.2. Procedures for identifying and isolating the affected medical cannabis to prevent or minimize its distribution to patients, caregivers, and other medical cannabis organizations and approved laboratories;
23.4.3. Procedures to retrieve and dispose of the affected medical cannabis; and
23.4.4. A communications plan to notify those affected by the recall, including:
23.4.4.a. The manner in which the grower/processor will notify other medical cannabis organizations or approved laboratories in possession of medical cannabis subject to the recall;
23.4.4.b. The use of press releases and other appropriate notifications to ensure that patients and caregivers are notified of the recall if the affected medical cannabis was dispensed to patients and caregivers;
23.4.5. Procedures for notifying the Bureau; and
23.4.6. Procedures for entering information relating to the recall into the grower/processor's electronic tracking system.
23.5. A grower/processor must follow the procedures outlined in its recall plan, unless the grower/processor obtains the prior written approval of the Bureau. The grower/processor must conduct recall procedures in a manner that maximizes the recall of affected medical cannabis and minimizes risks to public health and safety.
23.6. A grower/processor must coordinate the disposal of recalled medical cannabis with the Bureau. The Bureau or its authorized agents may oversee the disposal to ensure that the recalled medical cannabis is disposed of in a manner that will not pose a risk to public health and safety.
23.7. The grower/processor must enter information relevant to the recall into the electronic tracking system as part of the daily inventory, including:
23.7.1. The total amount of recalled medical cannabis, including types, forms, harvest batches, harvest lots, and process lots, if applicable;
23.7.2. The amount of recalled medical cannabis received by the grower/processor, including types, forms, harvest batches, harvest lots, and process lots, if applicable, by date and time;
23.7.3. The total amount of recalled medical cannabis returned to the grower/processor, including types, forms, harvest batches, harvest lots, and process lots, if applicable;
23.7.4. The names of the recall coordinators;
23.7.5. From whom the recalled medical cannabis was received;
23.7.6. The means of transport of the recalled medical cannabis;
23.7.7. The reason for the recall;
23.7.8. The number of recalled samples or test samples, types, forms, harvest batches, harvest lots, and process lots, if applicable, sent to approved laboratories, the names and addresses of the approved laboratories, the dates of testing, and the results by sample or test sample;
23.7.9. The manner of disposal of the recalled medical cannabis, including:
23.7.9.a. The name of the individual overseeing the disposal of the recalled medical cannabis;
23.7.9.b. The name of the disposal company, if applicable;
23.7.9.c. The method of disposal;
23.7.9.d. The date of disposal;
23.7.9.e. The amount disposed of by types, forms, harvest batches, harvest lots, and process lots, if applicable; and
23.7.10. Any other information required by the Bureau.
W. Va. Code R. § 64-110-24 Pesticides
24.1. The use of a pesticide by a grower/processor in the growing or processing of medical cannabis must be in accordance with the West Virginia Pesticide Control Act (W. Va. Code §19-16A-1 et seq.) and this rule.
24.2. The Bureau and the West Virginia Department of Agriculture will cooperate to inspect for and enforce the requirements of this section.
24.3. The following apply regarding recordkeeping requirements for pesticide applications:
24.3.1. The grower/processor shall maintain a record of each application of a pesticide. The record must include the following information:
24.3.1.a. The date of application. For a pesticide requiring a re-entry time, the date of application must include the hour completed;
24.3.1.b. The place of application, including the specific block, section, or immature medical cannabis plants or medical cannabis plants treated;
24.3.1.c. The size of the area treated;
24.3.1.d. The product name of every pesticide used;
24.3.1.e. The United States Environmental Protection Agency product registration number. This requirement is unnecessary for products exempted under section 25 of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.A. § 136w);
24.3.1.f. The total amount of every pesticide used in pounds, ounces, gallons, or liters applied to a treated area;
24.3.1.g. The dosage or rate of application of every pesticide used;
24.3.1.h. If applicable, the employee identification numbers of the individuals involved in making the pesticide and the permit or certification numbers of the individuals making or supervising the application; and
24.3.1.i. Copies of pesticide labels and Safety Data Sheets for the pesticides used at the facility.
24.3.2. A record required to be kept under this section must be completed within 24 hours of the completion of the application and maintained for at least four years. A record must be made immediately available to the Bureau or its authorized agents and medical personnel or first responders in an emergency. A record must be made available to the Bureau upon request.
24.4. For purposes of enforcement, the West Virginia Pesticide Control Act and 61CSR12A (Certified Pesticide Application Rule), 61CSR12G (General Groundwater Protection Rules for Pesticides), and 61CSR12H (Bulk Pesticide Operational Rules) are incorporated by reference and adopted as standards for use by the Bureau in enforcing this section.
24.5. A grower/processor must only use the pesticide active ingredients in Appendix A in the growing and processing of medical cannabis.
24.6. The following words and terms, when used in this section, have the following meanings, unless the context clearly indicates otherwise:
24.6.1. “Defoliant” means a substance or mixture of substances intended for causing the leaves or foliage to drop from a plant, with or without causing abscission.
24.6.2. “Desiccant” means a substance or mixture of substances intended for artificially accelerating the drying of plant tissue.
24.6.3. “Pesticide” means a substance or mixture of substances intended for preventing, destroying, repelling, or mitigating a pest, and a substance or mixture of substances intended for use as a plant regulator, defoliant, or desiccant.
24.6.4. “Plant regulator” means:
24.6.4.a. A substance or mixture of substances intended, through physiological action, for accelerating or retarding the rate of growth or rate of maturation, or for otherwise altering the behavior of plants or the produce thereof, but may not include substances to the extent that they are intended as plant nutrients, trace elements, nutritional chemicals, plant inoculants, and soil amendments.
24.6.4.b. The term does not include any of the nutrient mixtures or soil amendments commonly known as vitamin-hormone horticultural products, which are intended for improvement, maintenance, survival, health, and propagation of plants, and are not for pest destruction and are nontoxic, nonpoisonous in the undiluted packaged concentration.
W. Va. Code R. § 64-110-25 Treatment and quarantine orders
25.1. If a grower/processor fails or refuses to eradicate a plant pest that is found at its facility, the Bureau, in cooperation with the West Virginia Department of Agriculture, may issue and enforce a treatment order against the grower/processor, including an order to eradicate, for any immature medical cannabis plants or medical cannabis plants that may carry or harbor the plant pest. The order will be issued in writing and set forth the necessary treatment, control, or eradication measures required. If the grower/processor fails or refuses to comply with the order, the Bureau, acting in cooperation with the West Virginia Department of Agriculture, may carry out the control measures established in the treatment order with all expenses associated with the measures accruing to the grower/processor.
25.2. The West Virginia Department of Agriculture, acting with the cooperation of the Bureau, may establish a quarantine to prevent the dissemination of plant pests within this state or to prevent or delay the introduction of a plant pest into this state from any country, state, or territory. The following apply:
25.2.1. Upon finding a plant pest in a facility that has the potential to cause serious damage to other grower/processors or to agriculture in general, the geographic area in which the plant pest was found and any adjacent areas as the West Virginia Department of Agriculture deems necessary may be quarantined.
25.2.2. The quarantine order will establish conditions and restrictions determined by the West Virginia Department of Agriculture to be necessary to prevent or reduce the movement of the plant pest from the quarantined area. Vehicles or any means of conveyance suspected of carrying the plant pest may also be subject to quarantine and a treatment order under subsection 25.1. may be issued as necessary to eradicate the plant pest.
25.2.3. The quarantine order may regulate the planting, growing, or harvesting of any immature medical cannabis plants, or medical cannabis plants that serve as a host or reservoir for the plant pest within the quarantined area and may include prohibiting the processing of a specific harvest batch or harvest lot of medical cannabis within a specific geographic area or during a specified time period. An immature medical cannabis plant or medical cannabis plant suspected of harboring the plant pest may be ordered to be treated or destroyed.
W. Va. Code R. § 64-110-26 Administrative Due Process
26.1 Those persons adversely affected by the enforcement of this rule desiring a contested case hearing to determine any rights, duties, interests or privileges shall do so in accordance with 64CSR1, Rules of Procedure for Contested Case Hearings and Declaratory Rulings.
Appendix A. Acceptable Pesticide Active Ingredients for Use The following pesticides can be used legally in the growing and processing of medical cannabis and in accordance with the West Virginia Pesticide Control Act (W. Va. Code §19-16A-1 et seq.). Products containing the following active ingredients must also be labeled for use in greenhouses on food crops to qualify.
EPA Status Pesticide Type Comments Active Ingredient Castor Oil Castor Oil Cinnamon Cinnamon Oil Citric Acid Bactericide, Fungicide Clove Clove Oil Corn Oil Cottonseed Oil Garlic Insect Repellant Garlic Oil Geranoil Geranium Oil Lemon Grass Oil Peppermint Oil Peroxyaceitic Acid Potassium Sorbate Rosemary Rosemary Oil Fungicide, Insecticide, Miticide Sesame Oil Sodium Lauryl Sulfate Soybean Oil Thyme EPA Status Pesticide Type Comments Active Ingredients Fungicide, Insecticide, Miticide Thyme Oil White Pepper Azadirachtin Bacillus Amyloliquefaciens Strain D747 For use in protected growing environments only (for example, greenhouses)
Bacillus Pumilus Strain GHA 180 Bacillus Subtilis QST713 Strain Bacillus Thuringiensis SSP. Aizawai Canola Oil Insect Repellent Capsicum Oleoresin Extract Ground application only to nonblooming plants.
Chromobacterium Sub Strain PRAA4-1 Cells Clarified Hydrophobic Extract of Neem Oil Copper Octanoate PGR Cytokinin (Kinetin)
Diatomaceous Earth PGR Gibberellins (Gibberellic Acid)
PGR Harpin Alpha Beta Antimicrobial, Fungicide No foliar applications allowed.
Hydrogen Peroxide PGR Applications allowed in furrow at planting or in hydroponics only.
IBA (Indole-3Butyric Acid)
EPA Status Pesticide Type Comments Active Ingredient Insecticide, PGR Kaolin Mineral Oil Use only allowed prior to final transplant, unless grown in recirculating hydroponics systems.
Mono-Potassium and Di-Potassium Salts of Phosphorous Acid Monopotassium Phosphate Nematicide Myrothecium Verrucaria Neem Oil, Cold Pressed Use allowed prior to final transplant Potassium Laurate Potassium Salts of Fatty Acids Pyrethrins Molluscicide Sodium Ferric EDTA Trichoderma Asperellum Strain
Series 111 Medical Cannabis Program - Laboratories
W. Va. Code R. § 64-111-1 General
1.1. Scope. The provisions of this rule regulate the certification and operation of laboratories that provide testing services to medical cannabis organizations authorized by the West Virginia Medical Cannabis Act (W. Va. Code §16A-1-1 et seq.)
1.2. Authority. W. Va. Code §16A-3-1(b) and §16A-7-3.
1.3. Filing Date. May 8, 2025.
1.4. Effective Date. May 8, 2025.
1.5. Sunset Provision. This rule will terminate and have no further force or effect on August 1, 2030.
1.6. Applicability. This rule applies to a person or entity that holds or desires to hold a permit as a medical cannabis organization in the state.
W. Va. Code R. § 64-111-2 Definitions
2.1. “Act” means the West Virginia Medical Cannabis Act (W. Va. Code §16A-1-1 et seq.).
2.2. “Accreditation body” means an organization which:
2.2.1. Certifies the competency, expertise, and integrity of a laboratory and operates in conformance with the current version of International Organization Standard ISO/IEC 17011;
2.2.2. Determines a laboratory's compliance with and conformance to the relevant standards established by the International Organization for Standardization, including ISO/IEC 17025;
2.2.3. Is a signatory to the International Laboratory Accreditation Cooperation Mutual Recognition Arrangement for Testing; and
2.2.4. Is not affiliated with a laboratory applicant for which it has or will issue a certificate of accreditation.
2.3. “Approved laboratory” means a laboratory that has applied for, and received, the approval of the Bureau to identify, collect, handle, and conduct tests on samples from a grower/processor and test samples from the Bureau used in the growing, processing, or dispensing of medical cannabis as required by the Act and this rule.
2.4. “Bureau” means the West Virginia Bureau for Public Health within the West Virginia Department of Health.
2.5. “Certificate of accreditation” means a document issued by an accreditation body evidencing that a laboratory is in compliance with International Organization for Standardization Standard ISO/IEC 17025 and other requirements relevant to the operation of laboratories conducting tests on medical cannabis and other items used in the growing, processing, or dispensing of medical cannabis.
2.6. “Certificate of analysis” means a document that confirms that the test performed by an approved laboratory on a harvest batch, harvest lot, or process lot meets the testing requirements set forth by the Bureau.
2.7. “Chain of custody” means the written procedures used by employees of an approved laboratory to record the possession and transfer of samples and test samples from the time the samples and test samples are collected until the test of the sample or test sample is completed.
2.8. “Dispensary” means:
2.8.1. A person who holds a permit issued by the Bureau to dispense medical cannabis.
2.8.2. The term does not include a health care medical cannabis organization as defined under W. Va. Code §16A-13-1 et seq.
2.9. “Electronic tracking system” means an electronic seed-to-sale system prescribed by the Bureau that is implemented by:
2.9.1. A grower/processor to log, verify, and monitor the receipt, use, and sale of seeds, immature medical cannabis plants, or medical cannabis plants, the funds received by a grower/processor for the sale of medical cannabis to another medical cannabis organization, the disposal of medical cannabis waste, and the recall of defective medical cannabis.
2.9.2. A dispensary to log, verify, and monitor the receipt of medical cannabis product from a grower/processor, the verification of the validity of an identification card presented by a patient or caregiver, the dispensing of medical cannabis product to a patient or caregiver, the disposal of medical cannabis waste, and the recall of defective medical cannabis.
2.9.3. An approved laboratory to log, verify, and monitor the receipt of samples and test samples for testing, the results of tests performed by the approved laboratory, and the disposal of tested and untested samples.
2.10. “Grower/processor means:
2.10.1. A person who holds a permit from the Bureau under the Act to grow or process medical cannabis.
2.10.2. The term does not include a health care medical cannabis organization as defined under W. Va. Code §16A-13-1 et seq.
2.11. “Harvest batch” means a specifically identified quantity of medical cannabis plant that is uniform in strain, cultivated utilizing the same growing practices, harvested at the same time and at the same location, and cured under uniform conditions.
2.12. “Harvest lot” means a specifically identified quantity of medical cannabis plant taken from a harvest batch.
2.13. “Health care medical cannabis organization” means a vertically integrated health system approved by the Bureau to dispense medical cannabis or grow and process medical cannabis, or both, in accordance with a research study under W. Va. Code §16A-13-1 et seq.
2.14. “Laboratory applicant” means a laboratory that submits an application to the Bureau for approval to identify, collect, handle, and test medical cannabis and other items used by a medical cannabis organization in the growing, processing, or dispensing of medical cannabis as required under the Act and this rule for the Bureau or a grower/processor.
2.15. “Medical cannabis” means cannabis that is grown and sold pursuant to the provisions for certified medical use as set forth in the Act and in a form set forth in the provisions of 64CSR110, Medical Cannabis Program – Growers/Processors.
2.16. “Medical cannabis extract” means a substance obtained by separating cannabinoids from medical cannabis plants by a mechanical, chemical, or other process.
2.17. “Medical cannabis organization” means:
2.17.1. A dispensary or a grower/processor.
2.17.2. The term does not include a health care medical cannabis organization under W. Va. Code §16A-13-1 et seq. or a clinical registrant under W. Va. Code §16A-14-1 et seq.
2.18. “Medical cannabis product” means the final form and dosage of medical cannabis that is grown, processed, produced, sealed, labeled, and tested by a grower/processor and sold to a dispensary.
2.19. “Pharmacist” has the same meaning as the term does in W. Va. Code §30-5-1 et seq. (The Larry W. Border Pharmacy Practice Act).
2.20. “Physician” has the same meaning as the term does in W. Va. Code §30-3-1 et seq. (The West Virginia Medical Practice Act) and W. Va. Code §30-14-1 et seq. (Osteopathic Physicians and Surgeons).
2.21. “Process lot” means any amount of a medical cannabis product of the same type and processed using the same medical cannabis extract, standard operating procedures, and the same or combination of different harvest lots.
2.22. “Processing” means the compounding or conversion of medical cannabis extract by a grower/processor into a medical cannabis product.
2.23. “Sample” means medical cannabis collected by an employee of an approved laboratory from a grower/processor for testing by the laboratory.
2.24. “Test sample” means an amount of medical cannabis or an amount of soil, growing medium, water, or solvents used to grow or process medical cannabis, dust, or other particles obtained from the swab of a counter or equipment used in the growing or processing of medical cannabis, or other item used in the growing or processing of medical cannabis in a facility taken by an employee of an approved laboratory or an agent of the bureau at the request of the bureau from a grower/processor and provided to an approved laboratory for testing.
W. Va. Code R. § 64-111-3 Laboratories generally
3.1. A laboratory may not identify, collect, handle, or conduct tests on samples from a grower/processor or conduct tests on test samples for the Bureau unless the laboratory has been approved by the Bureau under section 4 of this rule and has entered into a written contract with the grower/processor under section 10 of this rule.
3.2. The Bureau will post on its web site a current list of approved laboratories.
3.3. An approved laboratory must employ at least one director to oversee and be responsible for the identification, collection, handling, and testing operations of the approved laboratory. A director must have earned, from a college or university accredited by a national or regional accrediting authority, at least one of the following:
3.3.1. A doctorate of science or an equivalent degree in chemistry, biology, or a subdiscipline of chemistry or biology;
3.3.2. A master's level degree in a chemical or biological science and a minimum of two years post graduate degree laboratory experience related to testing of medicinal or pharmaceutical products or other experience as approved by the Bureau; or
3.3.3. A bachelor's degree in a biological science and a minimum of four years post graduate degree laboratory experience related to testing of medicinal or pharmaceutical products or other experience as approved by the Bureau.
3.4. A principal or employee of a medical cannabis organization may not also own, be employed by, or affiliated with, an approved laboratory that has a contract with that medical cannabis organization.
3.5. An approval issued by the Bureau to a laboratory under this rule is valid for two years from the date of issuance and is valid only for the laboratory named and the location specified in the approval.
3.6. An approval issued by the Bureau to a laboratory under this rule is not transferable to any other person or any other location unless the laboratory obtains the prior written consent of the Bureau.
W. Va. Code R. § 64-111-4 Approval of laboratories
4.1. A laboratory intending to identify, collect, handle, and conduct tests on samples and test samples and other items used by a grower/processor in the growing and processing of medical cannabis as required under the Act and this rule must submit an application for approval to the Bureau on a form and in a manner prescribed by the Bureau, in addition to the prescribed fee. The application is available on the Bureau’s website.
4.2. An application submitted under this section must include the following information:
4.2.1. The name and address of the laboratory applicant or its authorized agent.
4.2.2. The name and address of the owner of the laboratory applicant, and, if applicable, the medical or pharmacy licensure information regarding the owner.
4.2.3. The name of the laboratory applicant's proposed director and technical personnel who are or will be employed by the laboratory at the location to be approved.
4.2.4. A copy of the laboratory applicant's most recent valid certificate of accreditation granted from an ILAC MRA recognized accreditation body.
4.2.5. Copies of the standard operating procedures and sampling procedures adopted by the laboratory applicant and approved by the accreditation body that issued the certificate of accreditation to the laboratory applicant.
4.2.6. A list of the specialized laboratory equipment utilized or to be utilized by the laboratory applicant in its testing operations, including the manufacturer's name and the serial and model number of the equipment, and other specifications as may be required by the Bureau.
4.2.7. A description of the accredited tests which are capable of being conducted by the laboratory applicant at the location to be approved.
4.2.8. A description of the laboratory applicant's quality assurance program, which must be in compliance with section 13 of this rule.
4.2.9. The procedures to be followed to establish chain of custody when collecting samples or test samples.
4.2.10. A copy of the evaluation process that the laboratory applicant uses or will use to monitor, evaluate, and document the competency of employees when testing samples and test samples and overseeing quality assurance controls.
4.2.11. Other information required by the Bureau.
4.3. By submitting an application for approval to the Bureau, a laboratory applicant consents to an investigation, to the extent deemed appropriate by the Bureau, of the laboratory applicant's ability to meet the requirements under the Act and this rule.
4.4. An application for approval submitted under this rule must include a statement that a false statement made in the application is punishable under the applicable provisions of W. Va. Code §61-3-37.
4.5. The Bureau may issue an approval under this rule if the Bureau determines that the laboratory applicant is financially and professionally suitable to conduct the testing required under the Act and this rule.
W. Va. Code R. § 64-111-5 Suspension or revocation of an approval issued to a laboratory
5.1. An approval issued by the Bureau under this rule may be suspended or revoked if the Bureau determines that the approved laboratory has engaged in unethical practices or has failed to do any of the following:
5.1.1. Maintain proper standards of accuracy.
5.1.2. Comply with the requirements of the Act or this rule applicable to the approved laboratory.
5.2. An approval issued by the Bureau under this rule may be revoked if the Bureau determines that the approved laboratory has engaged in any of the following conduct:
5.2.1. Dishonest reporting.
5.2.2. Repeated errors in conducting the required testing.
5.2.3. Allowing unauthorized individuals to perform testing or to sign reports.
5.2.4. Including false statements in the application for approval or renewal.
5.2.5. Advertising medical cannabis testing services to the general public.
5.2.6. Knowingly accepting a sample from an individual other than a grower/processor or a test sample from an individual other than the Bureau or an authorized agent of the Bureau.
5.2.7. Failing to maintain standard operating procedures approved by the accrediting body that issued the certificate of accreditation to the approved laboratory.
5.2.8. Failing to properly enter test results into the electronic tracking system.
5.2.9. Loss by the approved laboratory of its certificate of accreditation.
W. Va. Code R. § 64-111-6 Renewal of an approval issued to a laboratory
6.1. An approved laboratory intending to renew the approval issued to the laboratory under this rule must, not more than six months nor less than four months prior to the expiration of the approval, submit an application under section 4 of this rule and update all of the information required to be submitted with the application.
W. Va. Code R. § 64-111-7 Stability testing and retention of samples
7.1. A grower/processor must request that a sample be identified and collected by an approved laboratory from each harvest batch sufficient to perform stability testing at six-month intervals for a one-year period.
7.2. The stability test must be performed to ensure product potency and purity and provide support for expiration dating.
7.3. An approved laboratory must retain a sample from each harvest batch sufficient to provide for stability testing and properly store the sample for one year.
W. Va. Code R. § 64-111-8 Sampling procedures for testing
8.1. An approved laboratory must ensure that its employees prepare all samples in accordance with policies and procedures that include appropriate information necessary for identifying, collecting, and transporting samples in a manner that does not endanger the integrity of the samples for any testing required by this rule.
8.2. The sampling policies must at a minimum be:
8.2.1. Appropriate to the matrix being sampled.
8.2.2. In accordance with guidance provided by the Bureau.
8.3. The sampling procedures must include the following:
8.3.1. Surveying the conditions in which the sample is being stored.
8.3.2. Using appropriate sampling equipment and consistent procedures.
8.3.3. Selecting and removing equal portions for each sample.
8.3.4. Random or systematic taking of samples throughout the harvest batch or harvest lot.
8.3.5. Obtaining a minimum number of samples based on harvest batch or harvest lot size.
8.3.6. Checking all parts of the harvest batch when harvest lots are created from that harvest batch.
8.3.7. Recording on a form prescribed by the Bureau all observations and procedures used when collecting the sample.
8.3.8. Creating a unique sample identification number that will be linked to the harvest batch or harvest lot number assigned by the grower/processor in the electronic tracking system.
8.3.9. Entering all required information into the electronic tracking system.
W. Va. Code R. § 64-111-9 Selection protocols for samples
9.1. An employee of an approved laboratory may only enter a facility operated by a grower/processor for the purpose of identifying and collecting samples and must have access to limited access areas in the facility for these purposes.
9.2. An employee identifying and collecting samples under subsection 9.1. of this rule must follow the chain of custody procedures included in the approved laboratory's application and approved by the Bureau.
9.3. While at a facility operated by a grower/processor, an employee of an approved laboratory must identify and collect the following for testing:
9.3.1. Samples at the time of harvest.
9.3.2. Samples of medical cannabis product before being sold or provided to a dispensary.
9.3.3. Test samples at other times when requested by the Bureau.
W. Va. Code R. § 64-111-10 Testing requirements
10.1. Prior to conducting any testing of a sample at the request of a grower/processor, an approved laboratory must enter into a written contract with the grower/processor for testing services. The approved laboratory must provide a copy of the contract to the Bureau within two days following the Bureau's request.
10.2. A grower/processor must submit through the electronic tracking system a request to the approved laboratory with which it has a written contract under subsection 10.1. of this rule for each test to be conducted.
10.3. At a minimum, an approved laboratory must perform tests as prescribed by the Bureau on the following:
10.3.1. Samples from a harvest batch or harvest lot prior to being used to produce a medical cannabis product.
10.3.2. Samples from each process lot before the medical cannabis is sold or offered for sale to another medical cannabis organization.
10.4. The samples identified in subsection 10.3. of this rule must be tested, at a minimum, for the following:
10.4.1. Pesticides;
10.4.2. Solvents;
10.4.3. Water activity and moisture content;
10.4.4. THC and CBD concentration; and
10.4.5. Microbiological contaminants.
10.5. Sampling and testing under this rule must be conducted with a statistically significant number and size of samples and with methodologies acceptable to the Bureau to ensure that all harvest batches, harvest lots, and medical cannabis products are adequately tested for contaminants and that the cannabinoid profile is consistent throughout.
10.6. An approved laboratory may not test any samples when there is evidence of improper collection, improper preservation, apparent spoilage, excessive time lapse between collection of the sample and testing, or any other factor sufficient to render the findings of questionable validity.
10.7. An approved laboratory must enter into the electronic tracking system and, under 64CSR110-22 (Management and disposal of medical cannabis waste), properly dispose of all tested and untested samples and test samples.
W. Va. Code R. § 64-111-11 Standards for testing
11.1. An approved laboratory must follow the methodologies and parameters acceptable to the Bureau which are contained in the scope of the certificate of accreditation issued to the laboratory.
W. Va. Code R. § 64-111-12 Test results and reporting
12.1. Only the results of the following tests are in compliance with the testing requirements of this rule:
12.1.1. Tests conducted on harvest batch samples or harvest lot samples requested by a grower/processor under section 10 of this rule and identified and collected by an employee of an approved laboratory.
12.1.2. Tests conducted on process lot samples requested by a grower/processor under section 10 of this rule and identified and collected by either an employee of a grower/processor or an employee of an approved laboratory.
12.2. The test results for each sample must be entered into the electronic tracking system and must only be accessible to the grower/processor submitting the sample and to the Bureau.
12.3. If a sample fails any test required under section 10 of this rule, the following apply to the sample:
12.3.1. The approved laboratory that performed the initial test may re-test the sample upon a request from the grower/processor in accordance with subsection 12.4. of this rule.
13.3.2. If the sample passes the re-test, a second, confirmatory re-test must be performed using the same harvest batch, harvest lot, or process lot to confirm the passing test result.
12.3.3. If the Bureau does not agree to accept the results from the approved laboratory, the sample must be disposed of by the approved laboratory under 64CSR110-22 (Management and disposal of medical cannabis waste).
12.4. A grower/processor must notify the Bureau and the approved laboratory through the electronic tracking system of its intent to re-test the sample or test another sample from the same harvest batch, harvest lot, or process lot that failed a test.
12.5. An approved laboratory must issue to a grower/processor a certificate of analysis, including the supporting data, for each harvest batch, harvest lot, or process lot sample that was tested at the request of the grower/processor. The certificate of analysis must include:
12.5.1. Whether the chemical profile of the harvest batch, harvest lot, or process lot conforms to the chemical profile of the strain as determined by the Bureau for the following compounds:
12.5.1.a. Tetrahydrocannabinol (THC).
12.5.1.b. Tetrahydrocannabinol acid (THCA).
12.5.1.c. Tetrahydrocannabivarin (THCV).
12.5.1.d. Cannabidiol (CBD).
12.5.1.e. Cannabinadiolic acid (CBDA).
12.5.1.f. Cannabidivarine (CBDV).
12.5.1.g. Cannabinol (CBN).
12.5.1.h. Cannabigerol (CBG).
12.5.1.i. Cannabichromene (CBC).
12.5.1.j. Any other cannabinoid component at > 0.1percent.
12.5.2. That the presence of the following contaminants within the harvest batch, harvest lot, or process lot does not exceed the levels as determined by the Bureau for the following:
12.5.2.a. Heavy metals, mercury, lead, cadmium, or arsenic.
12.5.2.b. Foreign material such as hair, insects, or any similar or related adulterant.
12.5.2.c. Pesticide residue.
12.5.2.d. Any microbiological impurity, including:
12.5.2.d.1. Total aerobic microbial count.
12.5.2.d.2. Total yeast mold count.
12.5.2.d.3. P. aeruginosa.
12.5.2.d.4. Aspergillus spp.
12.5.2.d.5. S. aureus.
12.5.2.d.6. Aflatoxin B1, B2, G1 and G2.
12.5.2.d.7. Ochratoxin A.
12.5.2.d.8. E. coli.
12.5.2.d.9. Salmonella.
12.5.2.e. Whether the harvest batch, harvest lot, or process lot is within the specification for the strain for the characteristics of:
12.5.2.e.1. Odor.
12.5.2.e.2. Appearance.
12.5.2.e.3. Fineness.
12.5.2.e.4. Moisture content.
W. Va. Code R. § 64-111-13 Quality assurance program
13.1. An approved laboratory must establish and implement a quality assurance program to ensure that measurements are accurate, errors are controlled, and devices used for testing are routinely and properly calibrated.
13.2. The quality assurance program required under subsection 13.1. of this rule must include the following components:
13.2.1. An organizational chart that includes the testing responsibilities of each employee of the approved laboratory named in the chart.
13.2.2. A description of sampling procedures to be utilized.
13.2.3. Appropriate chain of custody protocols.
13.2.4. Analytical procedures.
13.2.5. Data reduction and validation procedures.
13.2.6. A plan for implementing corrective action, when necessary.
13.2.7. A requirement for the provision of quality assurance reports to management.
13.2.8. A description of the internal and external quality control systems.
W. Va. Code R. § 64-111-14 Transporting samples
14.1. An employee of an approved laboratory, grower/processor, or third-party contractor must follow the transportation requirements under 64CSR110-17 and 64CSR110-18 (Transportation of medical cannabis; and Transport manifest) when transporting a sample or test sample under this rule.
14.2. An employee of an approved laboratory, grower/processor, or third-party contractor who transports process lot samples from a grower/processor to an approved laboratory must:
14.2.1. Protect the physical integrity of the sample.
14.2.2. Keep the composition of the sample intact.
14.2.3. Protect the sample against factors that will interfere with the validity of testing results, including the factors of time, temperature, and other environmental factors that may work to jeopardize the integrity of the sample.
W. Va. Code R. § 64-111-15 Bureau request for testing
15.1. The Bureau may identify and collect a test sample from a grower/processor at any time and request an approved laboratory to conduct tests.
15.2. The approved laboratory must provide the Bureau with a written report of the test results from a test sample tested under subsection 15.1. of this rule within seven days of the collection of the test sample, or sooner if requested by the Bureau.
W. Va. Code R. § 64-111-16 Laboratory reporting
16.1. An approved laboratory must enter into the electronic tracking system the following information for each sample collected and each test conducted:
16.1.1. The unique sample identification number the approved laboratory assigns to the sample.
16.1.2. The name of the grower/processor that supplied the sample.
16.1.3. The employee identification number of the employee of the approved laboratory who identified and collected the sample at the request of the grower/processor.
16.1.4. The date and time the sample was collected from the grower/processor.
16.1.5. The date and time the sample was received by the approved laboratory.
16.1.6. The date the test was completed.
16.1.7. The condition of the sample when it was received by the approved laboratory.
16.1.8. A description of each test performed.
16.1.9. The results from the certificate of analysis issued under section 12 of this rule.
16.1.10. The date the testing results were provided to the grower/processor under section 12 of this rule or the Bureau under section 15 of this rule.
16.2. An approved laboratory must keep for four years a paper or electronic copy of the certificate of analysis performed on samples submitted by a grower/processor or test samples submitted by the Bureau. The laboratory must provide a copy of a certificate of analysis within two days of a request made by the Bureau.
W. Va. Code R. § 64-111-17 Advertising
17.1. An approved laboratory may not advertise, market, or otherwise promote its medical cannabis testing services to the general public. An approved laboratory may advertise, market, or otherwise promote its medical cannabis testing services to a grower/processor as provided in this section.
17.2. Advertising, marketing, and promotional materials proposed to be used by an approved laboratory under this section must be reviewed and approved by the Bureau prior to circulation or other use.
17.3. Personal solicitation by an employee, representative, or agent of an approved laboratory to a grower/processor is considered advertising, marketing, or otherwise promoting its medical cannabis testing services for the purposes of this section.
17.4. An approved laboratory may only advertise, market, or otherwise promote its medical cannabis testing services that are performed onsite at the location designated in the laboratory's application.
17.5. A sign installed at the location of an approved laboratory that is designed to identify the laboratory or access to the laboratory is permissible as long as the sign meets local zoning requirements and does not violate the provisions of this section.
W. Va. Code R. § 64-111-18 Ownership prohibition
18.1. The following individuals may not have a management or a direct or indirect financial or other ownership interest in an approved laboratory:
18.1.1. A principal, owner, financial backer, or employee of a medical cannabis organization.
18.1.2. A practitioner.
18.1.3. A physician or pharmacist who is currently employed by a medical cannabis organization.
18.1.4. Any other person, other than a patient, who may receive a direct or indirect financial benefit from the growing, processing, transporting, dispensing, or selling of medical cannabis.
W. Va. Code R. § 64-111-19 Administrative Due Process
19.1 Those persons adversely affected by the enforcement of this rule desiring a contested case hearing to determine any rights, duties, interests or privileges shall do so in accordance with 64CSR1, Rules of Procedure for Contested Case Hearings and Declaratory Rulings.
Series 112 Medical Cannabis Program - Dispensaries
W. Va. Code R. § 64-112-1 General
1.1. Scope. This rule includes general provisions related to dispensaries pursuant to the West Virginia Medical Cannabis Act (W. Va. Code §16A-1-1 et seq.)
1.2. Authority. W. Va. Code §16A-3-1(b) and §16A-7-3.
1.3. Filing Date. May 8, 2025.
1.4. Effective Date. May 8, 2025.
1.5. Sunset Provision. This rule will terminate and have no further force or effect on August 1, 2030.
1.6. Applicability. This rule applies to a person or entity that desires to hold a permit as a medical cannabis organization in the state.
W. Va. Code R. § 64-112-2 Definitions
2.1. “Act” means the West Virginia Medical Cannabis Act (W. Va. Code §16A-1-1 et seq.).
2.2. “Advertise” means the publication, dissemination, solicitation, or circulation that is visual, oral, written, or electronic to induce directly or indirectly an individual to patronize a particular dispensary or to purchase particular medical cannabis.
2.3. “Bureau” means the West Virginia Bureau for Public Health within the West Virginia Department of Health.
2.4. "Cannabis" means all parts of the plant of the genus cannabis, whether growing or not, the seeds thereof, the resin extracted from any part of the plant, and every compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds, or its resin, including cannabis concentrate. "Cannabis" does not include industrial hemp, nor does it include fiber produced from the stalks, oil, or cake made from the seeds of the plant, sterilized seed of the plant which is incapable of germination, or the weight of any other ingredient combined with cannabis to prepare topical or oral administrations, food, drink, or other product.
2.5. “CBD” means Cannabidiol.
2.6. “Caregiver” means the individual designated by a patient or, if the patient is under 18 years of age, an individual authorized under W. Va. Code §16A-5-1 et seq. to deliver medical cannabis.
2.7. “Device” means an object used, intended for use, or designed for use in preparing, storing, ingesting, inhaling, or otherwise introducing medical cannabis into the human body.
2.8. “Dispense” means the activity of lawfully providing to a patient or caregiver medical cannabis in a suitable container that is appropriately labeled for subsequent administration or use pursuant to a patient certification issued by a practitioner.
2.9. “Dispensary” means:
2.9.1. A person who holds a permit issued by the Bureau to dispense medical cannabis.
2.9.2. The term does not include a health care medical cannabis organization as defined by W. Va. Code §16A-13-1 et seq.
2.10. “Electronic tracking system” means an electronic seed-to-sale system prescribed by the Bureau that is implemented by:
2.10.1. A grower/processor to log, verify and monitor the receipt, use, and sale of seeds, immature medical cannabis plants, or medical cannabis plants, the funds received by a grower/processor for the sale of medical cannabis to another medical cannabis organization, the disposal of medical cannabis waste, and the recall of defective medical cannabis;
2.10.2. A dispensary to log, verify, and monitor the receipt of medical cannabis product from a grower/processor, the verification of the validity of an identification card presented by a patient or caregiver, the dispensing of medical cannabis product to a patient or caregiver, the disposal of medical cannabis waste, and the recall of defective medical cannabis; and
2.10.3. An approved laboratory to log, verify and monitor the receipt of samples and test samples for testing, the results of tests performed by the approved laboratory, and the disposal of tested and untested samples.
2.11. “Employee” means an individual who is hired for a wage, salary, fee, or payment to perform work for an applicant or permittee.
2.12. “Facility” means a structure and other appurtenances or improvements where a medical cannabis organization grows and processes or dispenses medical cannabis.
2.13. “Form of medical cannabis” means the characteristics of the medical cannabis recommended or limited for a particular patient, including the method of consumption and any particular dosage, strain, variety, and quantity or percentage of medical cannabis or particular active ingredient.
2.14. “Grower/processor means:
2.14.1. A person who holds a permit from the Bureau under the Act to grow or process medical cannabis.
2.14.2. The term does not include a health care medical cannabis organization as defined under W. Va. Code §16A-13-1 et seq.
2.15. “Health care medical cannabis organization” means a vertically integrated health system approved by the Bureau to dispense medical cannabis or grow and process medical cannabis, or both, in accordance with a research study under W. Va. Code §16A-13-1 et seq.
2.16. “Identification card” means a document issued under W. Va. Code §16A-5-1 that authorizes access to medical cannabis under the Act.
2.17. “Laboratory” means a place, establishment, or institution within the State of West Virginia that has been issued a certificate by the Bureau’s Office of Laboratory Services.
2.18. “Limited access area” means any area in a site or within a facility where:
2.18.1. Immature medical cannabis plants or seeds are stored, or medical cannabis plants are growing or being processed into medical cannabis;
2.18.2. Immature medical cannabis plants, medical cannabis plants, medical cannabis, or medical cannabis products are being loaded into or out of transport vehicles;
2.18.3. Medical cannabis is packaged for sale or stored;
2.18.4. Medical cannabis waste is processed, stored, or destroyed.
2.18.5. Surveillance system devices are stored.
2.19. “Medical cannabis” means cannabis that is grown and sold pursuant to the provisions for certified medical use as set forth in the Act and in a form set forth in the provisions of 64CSR110-10 (Forms of medical cannabis).
2.20. “Medical cannabis product” means the final form and dosage of medical cannabis that is grown, processed, produced, sealed, labeled, and tested by a grower/processor and sold to a dispensary.
2.21. “Medical cannabis organization” means:
2.21.1. A dispensary or a grower/processor.
2.21.2. The term does not include a health care medical cannabis organization under W. Va. Code §16A-13-1 et seq. or a clinical registrant under W. Va. Code §16A-14-1 et seq.
2.22. “Municipality” means an incorporated city or town in this state.
2.23. “Operational” means the time at which the Bureau determines that a dispensary is ready, willing, and able to properly carry on the activity for which a permit has been issued, including the implementation of an electronic tracking system.
2.24. “Operator” means an individual who directly oversees or manages the day-to-day business functions for an applicant or permittee and has the ability to direct employee activities onsite and offsite or within a facility for which a permit is issued.
2.25. “Patient” means an individual who:
2.25.1. Has a serious medical condition;
2.25.2. Has met the requirements for certification under the Act; and
2.25.3. Is a resident of the State of West Virginia.
2.26. “Permit” means an authorization issued by the Bureau to an applicant to conduct activities authorized under the Act.
2.27. “Person” means a natural person, corporation, foundation, organization, business trust, estate, limited liability company, licensed corporation, trust, partnership, limited liability partnership, association, or other form of legal business entity.
2.28. “Physician” means an individual currently licensed by this state to engage in the practice of medicine pursuant to the West Virginia Medical Practice Act (W. Va. Code §30-3-1 et seq.) and the Osteopathic Medical Practice Act (W. Va. Code §30-14-1 et seq.).
2.29. “Photocopy” means to copy printed material by a process in which an image is formed by the action of light, usually on an electrically charged surface, or the use any other electronic method to scan, create, and store records or documents.
2.30. “Practitioner” means a physician who is registered with the Bureau under W. Va. Code §16A-4-1.
2.31. “Serious medical condition” means any of the following conditions:
2.31.1. Cancer;
2.31.2. Positive status for Human Immunodeficiency Virus or Acquired Immune Deficiency Syndrome;
2.31.3. Amyotrophic lateral sclerosis;
2.31.4. Parkinson's disease;
2.31.5. Multiple sclerosis;
2.31.6. Damage to the nervous tissue of the spinal cord with objective neurological indication of intractable spasticity;
2.31.7. Epilepsy;
2.31.8. Neuropathies;
2.31.9. Huntington's disease;
2.31.10. Crohn's disease;
2.31.11. Post-traumatic stress disorder;
2.31.12. Intractable seizures;
2.31.13. Sickle cell anemia;
2.31.14. Severe chronic or intractable pain of neuropathic origin or severe chronic or intractable pain; or
2.31.15. Terminally ill.
2.32. “Site” means the total area contained within the property line boundaries in which a facility is operated by a dispensary.
2.33. “Terminally ill” means a medical prognosis of life expectancy of approximately one year or less if the illness runs its normal course.
2.34. “THC” means Tetrahydrocannabinol.
2.35. “Transport vehicle” means a vehicle that meets the requirements of the Act and is used to transport medical cannabis between medical cannabis organizations or between medical cannabis organizations and a laboratory.
2.36. “Unit” means the weight or volume of total usable medical cannabis in the finished product, calculated in metric units.
W. Va. Code R. § 64-112-3 Dispensaries generally
3.1. The qualifications that a dispensary must meet to receive a permit are continuing qualifications to maintain the permit.
3.2. In addition to any other requirements in the Act or this rule, a dispensary must comply with the following:
3.2.1. A dispensary may not engage in the business of possessing, dispensing, selling, or offering to dispense or sell medical cannabis to a patient or caregiver in this state without first being issued a permit by the Bureau and without first being determined operational by the Bureau as required under 64CSR109-15.
3.2.2. A dispensary may not employ an individual at its facility who is under 18 years of age.
3.2.3. A dispensary may not permit a patient to self-administer medical cannabis at the facility unless the patient is also an employee of the dispensary, and the dispensary permits self-administration of medical cannabis at the facility by the employees.
W. Va. Code R. § 64-112-4 Dispensing medical cannabis
4.1. A dispensary may only dispense medical cannabis to a patient or caregiver who presents a valid identification card to an employee at the facility who must verify the patient’s identity upon each visit/purchase.
4.2. Prior to dispensing medical cannabis to a patient or caregiver, the dispensary must:
4.2.1. Verify the validity of the patient or caregiver identification card using the electronic tracking system.
4.2.2. Review the information on the patient's most recent certification by using the electronic tracking system to access the Bureau's database. The following apply:
4.2.2.a. If a practitioner sets forth recommendations, requirements, or limitations as to the form or dosage of medical cannabis on the patient certification, the medical cannabis dispensed to a patient or a caregiver by a dispensary must conform to those recommendations, requirements, or limitations.
4.3. Prior to the completion of the transaction, the employee conducting the transaction at the dispensary must prepare a receipt of the transaction and file the receipt information with the Bureau utilizing the electronic tracking system. A dispensary must provide a copy of the receipt to the patient or the caregiver, unless the patient or the caregiver declines the receipt. The receipt must include the following information:
4.3.1. The name, address, and any permit number assigned to the dispensary by the Bureau.
4.3.2. The name and address of the patient and, if applicable, the patient's caregiver.
4.3.3. The date the medical cannabis was dispensed.
4.3.4. Any requirement or limitation noted by the practitioner on the patient's certification as to the form of medical cannabis that the patient should use.
4.3.5. The form and the quantity of medical cannabis dispensed.
4.4. Except as provided in W. Va. Code §16A-14-1 et seq., a dispensary must destroy any paper copy of the patient certification or delete any electronically recorded patient certification stored on the dispensary's network, server, or computer system as the result of a transaction after the receipt relating to that transaction has been filed under subsection 4.3.
W. Va. Code R. § 64-112-5 Limitations on dispensing
5.1. A dispensary may not dispense to a patient or caregiver:
5.1.1. A quantity of medical cannabis that is greater than the amount indicated on the patient's certification, if any.
5.1.2. A form or dosage of medical cannabis that is listed as a restriction or limitation on the patient certification.
5.1.3. A form of medical cannabis not permitted by the Act or this rule, unless otherwise provided in rules adopted by the Bureau under W. Va. Code §16A-11-2.
5.2. A dispensary may not dispense an amount of medical cannabis greater than a 30-day supply to a patient or caregiver until the patient has exhausted all but a seven-day supply provided pursuant to the certification currently on file with the bureau.
W. Va. Code R. § 64-112-6 Dispensary facilities
6.1. A dispensary may only dispense medical cannabis to a patient or caregiver in an indoor, enclosed, secure facility as approved by the Bureau.
6.2. A dispensary may not be located:
6.2.1. Within 1,000 feet of the property line of a public, private, or parochial school, or a day-care center;
6.2.2. At the same site used for growing and processing medical cannabis; or
6.2.3. In the same office space as a practitioner or other physician.
6.3. The Bureau may waive or amend the prohibition under subdivision 6.2.1., if it is shown by clear and convincing evidence that the waiver or amendment is necessary to provide patients with adequate access to medical cannabis. A waiver or amendment by the Bureau under this subsection may require additional security measures, changes to the physical plant of a facility, or other conditions necessary to protect individuals under 18 years of age and to prevent unauthorized access to medical cannabis.
6.4. No one under 18 years of age is permitted to enter a dispensary unless the individual is a patient or accompanied by a parent, guardian, or caregiver. If a dispensary facility is located adjacent to a commercial operation, the facility must provide additional means of security satisfactory to the Bureau to prevent individuals under 18 years of age from entering the facility from the commercial operation unless the individual is accompanied by an adult.
6.5. The following areas of a dispensary must be clearly marked with proper signage:
6.5.1. Limited access areas. All areas of ingress and egress to a limited access area must be clearly identified by the posting of a sign which must be not less than 12 inches wide and 12 inches long, composed of letters not less than one-half inch in height, which must state: “Do Not Enter—Limited Access Area. Access Limited to Authorized Personnel and Escorted Visitors.”
6.5.2. Areas that are open to patients and caregivers.
6.6. A dispensary must have an enclosed, secure area out of public sight for the loading and unloading of medical cannabis into and from a transport vehicle.
W. Va. Code R. § 64-112-7 Items and services provided at a dispensary
7.1. A dispensary must dispense the form of medical cannabis in accordance with section 4 of this rule.
7.2. A dispensary must purchase medical cannabis products only from a grower/processor.
7.3. A dispensary may sell, offer for sale, or provide at its facility, with the prior written approval of the Bureau, instruments, devices, and services related to the use of medical cannabis.
7.4. A dispensary may dispense a medical cannabis product so long as the dispensary purchases it from a grower/processor and the grower/processor obtained Bureau approval under 64CSR110-10 (Forms of medical cannabis).
7.5. A dispensary may not:
7.5.1. Advertise medical cannabis:
7.5.1.a. As a promotional item.
7.5.1.b. As part of a giveaway.
7.5.1.c. As part of a coupon program.
7.5.2. Provide medical cannabis at no cost or free.
7.5.3. Make the dispensing of medical cannabis to a patient or caregiver conditional upon:
7.5.3.a. The purchase of a medical device, instrument, or service provided at a dispensary facility.
7.5.3.b. The purchase of a medical device, instrument, or service provided at a location other than a dispensary facility.
7.5.4. Offer the delivery of or deliver medical cannabis to a patient or caregiver at the patient's or caregiver's home or any other location.
W. Va. Code R. § 64-112-8 Labels and safety inserts
8.1. Medical cannabis products dispensed by a dispensary must only be identified by the name of the grower/processor, the name of the dispensary, the form and species of medical cannabis, the percentage of THC and CBD contained in the medical cannabis product, and any other labeling required by the Bureau.
8.2. A dispensary must dispense medical cannabis to a patient or caregiver in a sealed and properly labeled package.
8.3. The dispensary must inspect the label to ensure that the label contains the following:
8.3.1. The information required to be included in the receipt in section 4 of this rule.
8.3.2. The packaging date.
8.3.3. A use by or expiration date.
8.3.4. The following warning stating: “This product is for medicinal use only. Women should not consume during pregnancy or while breastfeeding except on the advice of the practitioner who issued the certification and, in the case of breastfeeding, the infant's pediatrician. This product might impair the ability to drive or operate heavy machinery. Keep out of reach of children.”
8.3.5. The number of individual doses contained within the package and the species and percentage of THC and CBD.
8.3.6. A warning that the medical cannabis must be kept in the original container in which it was dispensed.
8.3.7. A warning that unauthorized use is unlawful and will subject the purchaser or user to criminal penalties.
8.3.8. Any other information required by the Bureau.
8.4. The dispensary must inspect the label to ensure that the label does not bear:
8.4.1. Any resemblance to the trademarked, characteristic, or product-specialized packaging of any commercially available food or beverage product.
8.4.2. Any statement, artwork, or design that could reasonably lead an individual to believe that the package contains anything other than medical cannabis.
8.4.3. Any seal, flag, crest, coat of arms, or other insignia that could reasonably mislead an individual to believe that the product has been endorsed, manufactured, or approved for use by any state, county, or municipality, or any agency thereof.
8.4.4. Any cartoon, color scheme, image, graphic, or feature that might make the package attractive to children.
8.5. When a dispensary dispenses medical cannabis to a patient or caregiver, the dispensary must also provide the patient or caregiver with a safety insert developed and approved by the Bureau that includes the following information:
8.5.1. The method or methods for administering individual doses of medical cannabis.
8.5.2. Any potential dangers stemming from the use of medical cannabis.
8.5.3. How to recognize what may be problematic usage of medical cannabis and how to obtain appropriate services or treatment for problematic usage.
8.5.4. The side effects and contraindications associated with medical cannabis, if any, which may cause harm to the patient.
8.5.5. How to prevent or deter the misuse of medical cannabis by an individual under 18 years of age or others.
8.5.6. Any other information determined by the Bureau to be relevant to enhance patient safety.
W. Va. Code R. § 64-112-9 Plans of operation
9.1. At the time the Bureau determines a dispensary to be operational, the dispensary must provide the Bureau with a full and complete plan of operation for review that includes the following:
9.1.1. Employment policies and procedures.
9.1.2. Security policies and protocols, including:
9.1.2.a. Staff identification measures.
9.1.2.b. Monitoring of attendance of staff and visitors.
9.1.2.c. Alarm systems.
9.1.2.d. Video surveillance.
9.1.2.e. Monitoring and tracking inventory.
9.1.2.f. Personnel security.
9.1.3. A process for receiving, packaging, labeling, handling, tracking, transporting, storing, disposing, returning, and recalling products containing medical cannabis in accordance with all applicable laws, rules, and regulations.
9.1.4. Workplace safety.
9.1.5. Maintenance, cleaning, and sanitation of the site or facility, or both.
9.1.6. Inventory maintenance and reporting procedures.
9.1.7. The investigation of complaints and potential adverse events from other medical cannabis organizations, patients, caregivers, or practitioners.
9.1.8. The use of the electronic tracking system prescribed by the Bureau.
9.2. A dispensary must make the full and complete plan of operation available to the Bureau upon request and during any inspection of the site and facility.
W. Va. Code R. § 64-112-10 Visitor access to dispensary facilities
10.1. A dispensary must post a sign in a conspicuous location at each entrance of the facility that reads: “THESE PREMISES ARE UNDER CONSTANT VIDEO SURVEILLANCE. NO ONE UNDER THE AGE OF 18 IS PERMITTED TO ENTER UNLESS THE INDIVIDUAL IS A PATIENT OR ACCOMPANIED BY A PARENT, GUARDIAN, OR CAREGIVER.”
10.2. Except as provided in subsection 10.3., only authorized employees of a dispensary may enter a limited access area.
10.3. A dispensary must require visitors, including vendors and contractors requiring access to a limited access area in the dispensary's facility, to present valid government-issued identification, sign a visitor log, and wear a visitor identification badge that is visible to others at all times while in a limited access area.
10.4. When admitting a visitor under subsection 10.3. to a limited access area, a dispensary must:
10.4.1. Require the visitor to sign a visitor log upon entering and leaving the limited access area;
10.4.2. Check the visitor's government-issued identification to verify that the name on the identification provided matches the name in the visitor log. A photocopy of the identification must be retained with the log;
10.4.3. Issue a visitor identification badge with the visitor's name and company, if applicable, and a badge number;
10.4.4. Escort the visitor while the visitor remains in a limited access area; and
10.4.5. Ensure that the visitor does not touch any medical cannabis located in a limited access area.
10.5. The following apply regarding the visitor log required under subsections 10.3. and 10.4.:
10.5.1. The dispensary must maintain the log for two years and make the log available to the Bureau, state, or local law enforcement and other state government officials upon request, if necessary, to perform the government officials’ functions and duties.
10.5.2. The log must include the full name of each visitor, the visitor identification badge number, the time of arrival, the time of departure, and the purpose of the visit, including the areas visited and the name of each employee visited.
10.6. This section does not limit the right of the Bureau or its authorized agents, or other federal, state, or local government officials, from entering any area of a dispensary, if necessary to perform the government officials' functions and duties.
10.7. A principal, financial backer, operator, or an employee of a dispensary may not receive any type of consideration or compensation for allowing a visitor to enter a limited access area.
W. Va. Code R. § 64-112-11 Security and surveillance
11.1. A dispensary must have security and surveillance systems, utilizing commercial-grade equipment, to prevent unauthorized entry, and to prevent and detect an adverse loss. The security and surveillance systems must include the following:
11.1.1. A professionally monitored security alarm system that includes the following:
11.1.1.a. Coverage of all facility entrances and exits; rooms with exterior windows, exterior walls, roof hatches, or skylights; storage rooms, including those that contain medical cannabis, and safes; and the perimeter of the facility.
11.1.1.b. A silent security alarm system signal, known as a duress alarm, generated by the entry of a designated code into an arming station in order to signal that the alarm user is being forced to turn off the system.
11.1.1.c. An audible security alarm system signal, known as a panic alarm, generated by the manual activation of a device intended to signal a life-threatening or emergency situation requiring law enforcement response.
11.1.1.d. A silent alarm signal, known as a holdup alarm, generated by the manual activation of a device intended to signal a robbery in progress.
11.1.1.e. An electrical, electronic, mechanical, or other device capable of being programmed to send a prerecorded voice message requesting dispatch, when activated, over a telephone line, radio, or other communication system to a law enforcement, public safety, or emergency services agency.
11.1.1.f. A failure notification system that provides an audible, text, or visual notification of any failure in the systems. The failure notification system must provide by telephone, e-mail, or text message an alert to a designated security person within the facility within five minutes after the failure.
11.1.1.g. Smoke and fire alarms.
11.1.1.h. Auxiliary power sufficient to maintain security and surveillance systems for at least 48 hours following a power outage.
11.1.1.i. The ability to ensure all access doors are not solely controlled by an electronic access panel to prevent locks from becoming released during a power outage.
11.1.1.j. Motion detectors.
11.1.2. A professionally monitored security and surveillance system that is operational 24 hours a day, seven days a week, and records all activity in images capable of clearly revealing facial detail. The security and surveillance system must include the following:
11.1.2.a. Fixed camera placement that allows for a clear image of all individuals and activities in and around the following:
11.1.2.a.1. Any area of the facility where medical cannabis is loaded or unloaded into or from transport vehicles.
11.1.2.a.2. Entrances to and exits from the facility. Entrances and exits must be recorded from both indoor and outdoor vantage points.
11.1.2.a.3. Rooms with exterior windows, exterior walls, roof hatches or skylights, and storage rooms, including those that may contain medical cannabis and safes.
11.1.2.a.4. Five feet from the exterior of the perimeter of the facility.
11.1.2.a.5. All limited access areas.
11.1.2.b. Auxiliary power sufficient to maintain security and surveillance systems for at least 48 hours following a power outage.
11.1.2.c. Ability to operate under the normal lighting conditions of each area under surveillance.
11.1.2.d. Ability to immediately produce a clear, color, still photograph in a digital format that meets the requirements of this subsection.
11.1.3. Ability to clearly and accurately display the date and time. The date and time must be synchronized and set correctly and may not significantly obscure the picture.
11.1.4. Ability to record all images captured by each surveillance camera in a format that may be easily accessed for a period not less than 180 days, unless otherwise required for investigative or litigation purposes as described in paragraph 11.2.5.b. The recordings must be kept:
11.1.4.a. At the facility:
11.1.4.a.1. In a locked cabinet, closet, or other secure place to protect it from tampering or theft; and
11.1.4.a.2. In a limited access area or other room to which access is limited to authorized individuals; or
11.1.4.b. At a secure location other than the location of the facility if approved by the Bureau.
11.1.5. A security alarm system separate from the facility's primary security system covering the limited access area or other room where the recordings under subdivision 12.1.4. are stored. The separate security alarm system must meet the same requirements as the facility's primary security alarm system.
11.2. The following apply regarding the inspection, servicing, or alteration of, and the upgrade to, the dispensary facility's security and surveillance systems:
11.2.1. The systems must be inspected, and all devices tested once every year by a qualified alarm system vendor and a qualified surveillance system vendor, as approved by the Bureau.
11.2.2. The dispensary must conduct maintenance inspections once every month to ensure that any repairs, alterations, or upgrades to the security and surveillance systems are made for the proper operation of the systems.
11.2.3. The dispensary must retain at the facility, for at least four years, records of all inspections, servicing, alterations, and upgrades performed on the systems and must make the records available to the Bureau and its authorized agents within two business days following a request.
11.2.4. In the event of a mechanical malfunction of the security or surveillance system that the dispensary anticipates will exceed a four-hour period, the dispensary must notify the Bureau immediately and, with Bureau approval, provide alternative security measures that may include closure of the facility.
11.2.5. The dispensary must designate an employee to continuously monitor the security and surveillance systems at the facility.
11.2.6. The following apply regarding records retention:
11.2.6.a. Within two business days following a request, a dispensary must provide screen captures of an unaltered copy of a video surveillance recording to the Bureau or its authorized agents, law enforcement, or other federal, state, or local government officials, if necessary to perform the government officials' functions and duties.
11.2.6.b. If a dispensary has been notified in writing by the Bureau or its authorized agents, law enforcement, or other federal, state, or local government officials of a pending criminal or administrative investigation for which a recording may contain relevant information, the dispensary must retain an unaltered copy of the recording for two years or until the investigation or proceeding is closed or the entity conducting the investigation or proceeding notifies the dispensary that it is not necessary to retain the recording, whichever is longer.
11.3. A dispensary must install commercial-grade, nonresidential doors and door locks on each external door of the facility. Keys or key codes for all doors must remain in the possession of designated authorized individuals.
11.4. During all nonworking hours, all entrances to and exits from the facility must be securely locked.
11.5. A dispensary must have an electronic back-up system for all electronic records.
11.6. A dispensary must install lighting to ensure proper surveillance inside and outside of the facility.
11.7. A dispensary must limit access to a room containing security and surveillance monitoring equipment to persons who are essential to maintaining security and surveillance operations; federal, state, and local law enforcement; security and surveillance system service employees; the Bureau or its authorized agents; and other persons with the prior written approval of the Bureau. The following apply:
11.7.1. A dispensary must make available to the Bureau or the Bureau’s authorized agents, upon request, a current list of authorized employees and service employees, or contractors, who have access to any security and surveillance areas.
11.7.2. A dispensary must keep security and surveillance rooms locked at all times and may not use these rooms for any other purpose or function.
W. Va. Code R. § 64-112-12 Inventory data
12.1. A dispensary must maintain the following inventory data in its electronic tracking system:
12.1.1. Medical cannabis received from a grower/processor.
12.1.2. Medical cannabis dispensed to a patient or caregiver.
12.1.3. Damaged, defective, expired, or contaminated medical cannabis awaiting return to a grower/processor or disposal.
12.2. A dispensary must establish inventory controls and procedures to conduct monthly inventory reviews and annual comprehensive inventories of medical cannabis at its facility.
12.3. A written record must be created and maintained of each inventory which includes the date of the inventory, a summary of the inventory findings, and the names, signatures, and titles or positions of the individuals who conducted the inventory.
W. Va. Code R. § 64-112-13 Storage requirements
13.1. A dispensary must have separate locked limited access areas for storage of medical cannabis that is expired, damaged, deteriorated, mislabeled, contaminated, recalled, or whose containers or packaging have been opened or breached until the medical cannabis is returned to a grower/processor, destroyed, or otherwise disposed of as required under 64CSR110-22 (Management and disposal of medical cannabis waste).
13.2. A dispensary must maintain all storage areas in a clean and orderly condition and free from infestation by insects, rodents, birds, and pests.
W. Va. Code R. § 64-112-14 Sanitation and safety in a facility
14.1. A dispensary must maintain its facility in a sanitary condition to limit the potential for contamination or adulteration of the medical cannabis stored in or dispensed at the facility. The following apply:
14.1.1. Trash must be properly removed.
14.1.2. Floors, walls, and ceilings must be kept in good repair.
14.1.3. Adequate protection against pests must be provided through the use of integrated pest management practices and techniques that identify and manage pest problems, and the regular disposal of trash to prevent infestation.
14.1.4. Toxic cleaning compounds, sanitizing agents, solvents, and pesticide chemicals must be labeled and stored in a manner that prevents contamination of medical cannabis and in a manner that otherwise complies with other applicable laws and rules.
14.2. An employee must conform to sanitary practices while on duty, including the following:
14.2.1. Maintaining adequate personal hygiene.
14.2.2. Washing hands thoroughly in an adequate hand-washing area before starting work and at any other time when hands may have become soiled or contaminated and at all times before dispensing medical cannabis to a patient or caregiver.
14.3. A dispensary must provide its employees and visitors with adequate and convenient hand-washing facilities furnished with running water at a temperature suitable for sanitizing hands. The following apply:
14.3.1. Hand-washing facilities must be located where good sanitary practices require employees to wash and sanitize their hands.
14.3.2. Effective nontoxic sanitizing cleansers and sanitary towel service or suitable hand drying devices must be provided.
14.4. A dispensary must provide its employees and visitors with adequate, readily accessible lavatories that are maintained in a sanitary condition and in good repair.
14.5. A dispensary must comply with all other applicable state and local building code requirements.
W. Va. Code R. § 64-112-15 Transportation of medical cannabis
15.1. A dispensary may transport and deliver medical cannabis to a medical cannabis organization in this state in accordance with this section. The following apply:
15.1.1. A dispensary may deliver medical cannabis to a medical cannabis organization only between 7:00 a.m. and 9:00 p.m. for the purposes of transferring medical cannabis among the permittee's dispensary locations and returning medical cannabis to a grower/processor.
15.1.2. A dispensary may contract with a third-party contractor for delivery so long as the contractor complies with this section.
15.1.3. A dispensary may not transport medical cannabis to any location outside of this state.
15.1.4. A dispensary must use a global positioning system to ensure safe, efficient delivery of the medical cannabis to a medical cannabis organization.
15.2. Vehicles permitted to transport medical cannabis must:
15.2.1. Be equipped with a secure lockbox or locking cargo area.
15.2.2. Have no markings that would either identify or indicate that the vehicle is being used to transport medical cannabis.
15.2.3. Be capable of being temperature-controlled for perishable medical cannabis, as appropriate.
15.2.4. Display current state inspection stickers and maintain a current state vehicle registration.
15.2.5. Be insured in an amount that is commercially reasonable and appropriate.
15.3. A transport vehicle must be staffed with a delivery team consisting of at least two individuals and comply with the following:
15.3.1. At least one delivery team member must remain with the vehicle at all times that the vehicle contains medical cannabis.
15.3.2. Each delivery team member must have access to a secure form of communication with the dispensary, such as a cellular telephone, at all times that the vehicle contains medical cannabis.
15.3.3. Each delivery team member must carry an identification badge or card at all times and must, upon demand, produce it to the Bureau or its authorized agents, law enforcement, or other federal or state government officials, if necessary to perform the government officials’ functions and duties.
15.3.4. Each delivery team member must have a valid driver's license.
15.3.5. While on duty, a delivery team member may not wear any clothing or symbols that may indicate ownership or possession of medical cannabis.
15.4. Medical cannabis stored inside the transport vehicle may not be visible from the outside of the transport vehicle.
15.5. Except as provided in subsection 15.8., a delivery team must proceed in a transport vehicle from the dispensary, where the medical cannabis is loaded, directly to the medical cannabis organization, where the medical cannabis is unloaded, without unnecessary delays. Notwithstanding the foregoing, a transport vehicle may make stops at multiple facilities, as appropriate, to deliver medical cannabis.
15.6. A dispensary must immediately report to the Bureau, either through a designated phone line established by the Bureau or by electronic communication with the Bureau in a manner prescribed by the Bureau, any vehicle accidents, diversions, losses, or other reportable events that occur during transport of medical cannabis.
15.7. A dispensary must notify the Bureau daily of its delivery schedule, including routes and delivery times, either through a designated phone line established by the Bureau or by electronic communication with the Bureau in a manner prescribed by the Bureau.
15.8. A transport vehicle is subject to inspection by the Bureau or its authorized agents, law enforcement, or other federal or state officials, if necessary to perform the government officials’ functions and duties. A transport vehicle may be stopped and inspected along its delivery route or at any medical cannabis organization.
W. Va. Code R. § 64-112-16 Transport manifest
16.1. A dispensary must generate a printed or electronic transport manifest that accompanies every transport vehicle and contains the following information:
16.1.1. The name, address, and permit number of the dispensary, and the name of and contact information for a representative of the dispensary who has direct knowledge of the transport.
16.1.2. The name, address, and permit number of the medical cannabis organization receiving the delivery, and the name of and contact information for a representative of the medical cannabis organization.
16.1.3. The quantity, by weight or unit, of each medical cannabis batch or lot contained in the transport, along with the identification number for each batch or lot.
16.1.4. The date and approximate time of departure.
16.1.5. The date and approximate time of arrival.
16.1.6. The transport vehicle's make and model and license plate number.
16.1.7. The identification number of each member of the delivery team accompanying the transport.
16.2. When a delivery team delivers medical cannabis to multiple medical cannabis organizations, the transport manifest must correctly reflect the specific medical cannabis in transit. Each recipient must provide the dispensary with a printed receipt for the medical cannabis received.
16.3. All medical cannabis being transported must be packaged in shipping containers and labeled in accordance with 64CSR110-16 (Packaging and labeling of medical cannabis) and section 8 of this rule.
16.4. A dispensary must provide a copy of the transport manifest to the recipient receiving the medical cannabis described in the transport manifest. To maintain confidentiality, a dispensary may prepare separate manifests for each recipient.
16.5. A dispensary must, if requested, provide a copy of the printed transport manifest, and any printed receipts for medical cannabis being transported, to the Bureau or its authorized agents, law enforcement, or other federal or state government officials, if necessary to perform the government officials' functions and duties.
W. Va. Code R. § 64-112-17 Evidence of adverse loss during transport
17.1. If a dispensary receiving a delivery of medical cannabis from a medical cannabis organization discovers a discrepancy in the transport manifest upon delivery, the dispensary must refuse acceptance of the delivery and immediately report the discrepancy to the Bureau either through a designated phone line established by the Bureau or by electronic communication with the Bureau in a manner prescribed by the Bureau, and to the appropriate law enforcement authorities.
17.2. If a dispensary discovers evidence of, or reasonably suspects, a theft or diversion of medical cannabis during transport, the dispensary must immediately report its findings or suspicions to the Bureau either through a designated phone line established by the Bureau or by electronic communication with the Bureau in a manner prescribed by the Bureau, and to law enforcement.
17.3. If a dispensary discovers a discrepancy in the transport manifest, the dispensary must:
17.3.1. Conduct an investigation.
17.3.2. Amend the dispensary's standard plan of operation, if necessary, to prevent future discrepancies between the quantity or description of inventory listed in the transport manifest and the quantity or description of inventory delivered.
17.3.3. Submit a report of the investigation to the Bureau. The following apply:
17.3.3.a. A written preliminary report of the investigation must be submitted to the Bureau within seven days of discovering the discrepancy.
17.3.3.b. A final written report of the investigation must be submitted to the Bureau within 30 days of discovering the discrepancy.
W. Va. Code R. § 64-112-18 Complaints about or recall of medical cannabis
18.1. A dispensary must notify the Bureau and the grower/processor immediately upon becoming aware of any complaint made to the dispensary by a patient, caregiver, or practitioner who reports an adverse event from using medical cannabis dispensed by the dispensary.
18.2. Upon notification by the grower/processor under 64CSR110-23 (Complaints about or recall of medical cannabis), the dispensary must cease dispensing the affected medical cannabis.
18.3. A dispensary must coordinate the return of the recalled medical cannabis with the grower/processor.
W. Va. Code R. § 64-112-19 Electronic tracking system
19.1. A dispensary must use the electronic tracking system prescribed by the Bureau containing the requirements in W. Va. Code §16A-7-1. The Bureau will publish notice of the electronic tracking system to be utilized by a dispensary in the State Register 60 days prior to the implementation date of the system.
W. Va. Code R. § 64-112-20 Application for additional dispensary locations
20.1. An applicant for a dispensary permit must include at least one specified dispensary facility location in its initial permit application and may file an application under this section for additional dispensary facility locations at a later date.
20.2. A dispensary must submit an application for additional dispensary locations on a form prescribed by the bureau.
20.3. A dispensary submitting an application for additional dispensary locations must include with the application the following fees:
20.3.1. An application fee of $2,500, which is nonrefundable.
20.3.2. A permit fee of $10,000 for each dispensary location being proposed. The permit fee must be submitted with the application for additional dispensary locations and will be refunded if the application is not granted.
20.4. A dispensary may not begin operations at an additional location until the bureau approves the application for additional dispensary locations, in writing, under this section.
20.5. A dispensary submitting an application for additional dispensary locations must follow the requirements in 64CSR109 and this rule.
W. Va. Code R. § 64-112-21 Administrative Due Process
21.1 Those persons adversely affected by the enforcement of this rule desiring a contested case hearing to determine any rights, duties, interests or privileges shall do so in accordance with the 64CSR1, Rules of Procedure for Contested Case Hearings and Declaratory Rulings.
Series 115 Diabetes Self-Management Education
W. Va. Code R. § 64-115-1 General
1.1. Scope -- This rule establishes the training requirements and procedures necessary for diabetes self-management education to be provided by properly trained health care practitioners in West Virginia.
1.2. Authority -- W. Va. Code §33-59-1(k) and §16-1-4.
1.3. Filing Date -- April 13, 2026.
1.4. Effective Date -- July 1, 2026.
1.5. Sunset Provision -- This rule shall terminate and have no further force or effect upon August 1, 2031.
W. Va. Code R. § 64-115-2 Definitions
2.1. Commissioner -- The commissioner of the Bureau for Public Health of the West Virginia Department of Health.
2.2. Diabetes self-management education -- A diabetes self-management program currently recognized by the commissioner to educate patients diagnosed with diabetes in order to self-manage their condition.
2.3. Health care practitioner -- "Health care practitioner" or "practitioner" means a physician, pharmacist, nurse, registered dietitian, certified diabetes care and education specialist, or other health care practitioner who is licensed to perform specified medical or ancillary services within the scope of his or her license.
W. Va. Code R. § 64-115-3 Diabetes Self-Management Education
3.1. Persons diagnosed with diabetes shall be provided the opportunity to receive diabetes self-management education in accordance with W. Va. Code §33-59-1.
3.2. Diabetes self-management education will be offered to persons diagnosed with diabetes as follows:
3.2.1. At diagnosis;
3.2.2. Annually and/or when not meeting treatment targets;
3.2.3. When complicating factors develop; and
3.2.4. When transitions in life and care occur.
3.3. Diabetes self-management education may be provided to a person diagnosed with diabetes individually or in a group as currently allowed by that educational program.
3.4. Diabetes self-management education shall be provided by a health care practitioner that has completed training as currently recognized by the sponsoring or accrediting institution of the educational program that is provided.
3.5. A current list of all diabetes self-management programs recognized by the commissioner shall be maintained by the Bureau for Public Health at https://dhhr.wv.gov/hpcd/FocusAreas/wvdiabetes/Pages/Diabetes-Prevention-and-Self-Management-Programs.aspx, which shall include the name of the diabetes self-management program, the sponsoring or accrediting institution, and contact information for the program.
3.5.1. Diabetes self-management programs may offer telehealth education when resources are limited, and may otherwise communicate by telephone when patients lack access to broadband internet.
3.5.2. Diabetes self-management programs shall recommend one or more methods for the measurement of patient success, which may be used by the referring provider to evaluate patient success.
3.6. The Bureau for Public Health shall review the list of diabetes self-management programs recognized by the commissioner at least annually.
Series 116 Distribution of Funds from Emergency Medical Services Salary Enhancement Fund
W. Va. Code R. § 64-116-1 General
1.1. Scope. -- This legislative rule establishes a formula for the Director to use in distributing funds from the Emergency Medical Services Salary Enhancement Fund.
1.2. Authority. -- W. Va. Code §16-4C-25.
1.3. Filing Date. -- March 28, 2024.
1.4. Effective Date. -- March 28, 2024.
1.5. Sunset Provision. -- This rule shall terminate and have no further force or effect on August 1, 2029.
W. Va. Code R. § 64-116-2 Application and Enforcement
2.1. Application. -- This rule applies to the distribution, by the Director, of funds from the Emergency Medical Services Salary Enhancement Fund.
2.2. Enforcement. -- This rule is enforced by the Director of the Office of Emergency Medical Services.
W. Va. Code R. § 64-116-3 Definitions
3.1. Active Emergency Medical Services Personnel -- An Advanced Emergency Medical Technician, Emergency Medical Technician, Emergency Medical Vehicle Operator, or Paramedic who is a paid employee of an ambulance transporting agency and participates in 10 or more 911 call responses in a 12-month period.
3.2. Ambulance Transporting Agency -- A person or entity licensed to provide emergency medical services dispatched through a 911 call center for the purpose of responding to a 911 call.
3.3. County Questionnaire -- Questionnaire supplied to each county annually by the Director to assist in the allocation of funds in accordance with this rule.
3.4. Crisis Response -- Funds designated for and distributed to counties for the sole purpose of providing care to emergency medical services personnel during a mental health crisis by a trained designee.
3.5. Crisis Response Team -- Designated group of personnel trained to provide care to emergency medical services personnel during a mental health crisis.
3.6. Director -- The Director of the Office of Emergency Medical Services, as created by W. Va. Code §16-4C-4, or his or her designee.
3.7. Emergency Medical Services Region -- A defined region of coordinated resources to provide emergency medical services within a geographic area available at https://www.wvoems.org/files/maps/medical-command-map.
3.8. Fiscal Year -- 12-month period beginning July 1 and ending June 30.
3.9. Post-Fund Distribution Assessment -- Form supplied to each county annually by the Director to assist in the assessment and accounting of funds distributed in accordance with this rule.
3.10. Primary Agency -- An ambulance transporting agency at which active emergency medical services personnel are employed for 51 percent or more of their working hours.
3.11. Salary Supplementation -- Funds designated for and distributed to counties for the sole purpose of supplementing the salaries of active emergency medical services personnel in accordance with State law and this rule.
W. Va. Code R. § 64-116-4 Formula; Allocation of Funds; Distribution
4.1. The Director shall distribute funds for salary supplementation and crisis response to counties as directed by the State Legislature, this rule, and State law.
4.2. The amount of funds for salary supplementation and crisis response available for distribution to counties by the formula established by subsection 4.4. of this rule is the balance of available funds in the Emergency Medical Services Salary Enhancement Fund as established in W. Va. Code §16-4C-25(a).
4.3. Each county shall complete and submit a County Questionnaire attached to this rule as APPENDIX A. The County Questionnaire shall be supplied by the Director on or before August 1 of each year and shall be submitted to the Office of Emergency Medical Services on or before September 1 of each year. The questionnaire shall be used in determining the allocations of funds according to the formula established by subsection 4.4. of this rule. Counties that do not submit a completed County Questionnaire will be given scores of 0.
4.4. The Director shall calculate the amount of funds for salary supplementation and crisis response to be distributed to counties according to the following formula:
4.4.1. Step 1 Crisis Response: 10 percent of the funds available for distribution shall be divided equally among each emergency medical services region, as defined by the Office of Emergency Medical Services, and shall be allocated solely to the enhancement of crisis response services within each region. Within each region, the funds allocated shall be divided among counties according to the number of members each county supports on a crisis response team, as outlined below. These crisis response funds shall be expended for no purpose other than ensuring crisis response teams receive uniform training and coordination through a statewide program to ensure continuity of crisis response services.
4.4.1.a. Crisis response teams:
4.4.1.a.1. Each emergency medical services region shall establish a crisis response team consisting of no less than 10 active members.
4.4.1.a.2. The county commissions comprising each emergency medical services region shall cooperate to recruit crisis response team members. Each county having one or more members serving on a crisis response team shall receive funding according to the formula set forth in subsection 4.4.1.
4.4.2. Step 2 Counties demonstrating the most need: Counties that share at least one border with a neighboring state are assigned a coefficient of 4. Super Rural counties are assigned a coefficient of 4. Rural counties are assigned a coefficient of 2. Urban counties are assigned a coefficient of 0. Rurality is determined by the level of rurality on 51 percent of the zip codes in each county established by the most recent rurality index published by the Centers for Medicare and Medicaid Services available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AmbulanceFeeSchedule.
4.4.3. Step 3 Existing levy for emergency medical services: Counties with an existing levy for emergency medical services or a special emergency ambulance service fee pursuant to W. Va. Code §7-15-17 are assigned a coefficient of 3.
4.4.4. Step 4 Maximum allowable rate on regular levies:
4.4.4.a. Counties that have reached the maximum allowable rate on all regular levies are assigned a coefficient of 2.
4.4.4.b. Counties that have reached the maximum allowable rate on one half of the regular levies are assigned a coefficient of 1.
4.4.5. Step 5 Additional qualifying factors:
4.4.5.a. Counties that report an emergency medical services personnel vacancy rate of more than 20 percent are assigned a coefficient of 2.
4.4.5.b. Counties that report an emergency medical services personnel vacancy rate of between 10 and 20 percent are assigned a coefficient of 1.
4.4.5.c. Counties that report an emergency medical services personnel annual salary differential of a minimum of 10 percent lower than any bordering county are assigned a coefficient of 1.
4.4.5.d. Counties that report one or more cities or municipalities with no projected budget surplus during a fiscal year are assigned a coefficient of 1.
4.4.6. Step 6 County distribution: County distribution is determined by:
4.4.6.a. Adding the coefficients from Steps 2 through 5 for each county;
4.4.6.b. Tier 1: 50 percent of the available funds shall be divided equally among those counties with a coefficient total of 12 or greater; Tier 2: 35 percent of the available funds shall be divided equally among those counties with a coefficient total of 6, 7, 8, 9, 10, or 11; Tier 3: 15 percent of the available funds shall be divided equally among those counties with a coefficient total of 5 or less.
4.4.6.b.1. If no counties fall within Tier 2, the available funds that would be allocated to Tier 2 counties shall be divided in half; one half shall be redistributed equally among those counties falling within Tier 1, and one half shall be redistributed equally among those counties falling within Tier 3.
4.4.6.b.2. If no counties fall within Tier 3, the available funds that would be allocated to Tier 3 counties shall be redistributed equally among those counties falling within Tier 1.
4.4.6.b.3. If five or fewer counties fall within Tier 1, those counties falling within Tier 1 shall be assigned to Tier 2 and the available funds that would be allocated to Tier 1 counties shall be divided in half; one half shall be redistributed equally among those counties falling within Tier 2, and one half shall be redistributed equally among those counties falling within Tier 3.
4.4.6.b.4. If five or fewer counties fall within Tier 2, those counties falling within Tier 2 shall be assigned to Tier 3 and the available funds that would be allocated to Tier 2 counties shall be divided in half; one half shall be redistributed equally among those counties falling within Tier 1, and one half shall be redistributed equally among those counties falling within Tier 3.
4.4.6.b.5. If five or fewer counties fall within Tier 3, those counties falling within Tier 3 shall be assigned to Tier 2 and the available funds that would be allocated to Tier 3 counties shall be divided in half; one half shall be redistributed equally among those counties falling within Tier 1, and one half shall be redistributed equally among those counties falling within Tier 2.
4.5. In performing the assessment described in subsection 4.4. of this rule, the Director shall use the most recent information available as provided by each county.
4.6. The Director shall complete the assessments described in subsection 4.4. of this rule as soon as possible but no later than September 15 of each year.
4.7. After completing the assessments described in subsection 4.4. of this rule, the Director shall inform each county in writing of its allocation as soon as possible, but no later than October 1 of each year.
4.8. The Director shall cause funds for salary supplementation and crisis response, together with the post-fund distribution assessment attached to this rule as APPENDIX B, to be distributed to counties according to standard State procedures as soon as possible, but no later than November 1 of each year.
4.9. Counties receiving funds in accordance with this rule that house more than one ambulance transporting agency shall distribute funds to those agencies using a percentage allocation based upon 911 call volume. There is a presumption that active emergency medical services personnel will receive salary supplementation funds from their primary agency.
4.10. Counties receiving funds in accordance with this rule shall complete and submit the post-fund distribution assessment to the Office of Emergency Medical Services on or before December 1 of each year. Counties that fail to distribute funds in accordance with this rule may be disqualified from receipt of salary supplementation funds during the following calendar year.
W. Va. Code R. § 64-116-5 Administrative Due Process
5.1. Any person adversely affected by the enforcement of this rule desiring a contested case hearing to determine any rights, duties, interests, or privileges shall do so in a manner prescribed in the Bureau for Public Health’s procedural rule, Rules of Procedure for Contested Case Hearings and Declaratory Rulings, 64CSR1.
APPENDIX A 64CSR116. County Questionnaire.
Responding County Name__________________________ Date Completed_______________
APPENDIX B 64CSR116. Post-Fund Distribution Assessment.
Responding County Name__________________________ Date Completed_______________ PLEASE PROVIDE THE FOLLOWING INFORMATION FOR EACH AGENCY IN YOUR COUNTY Agency Name__________________________________ Total funding allocated by the county commission to agency pursuant to 64CSR116_________________ Please attach as an addendum the following: Name, Provider Number, and amount of salary supplementation distributed to each emergency medical services provider at each agency in your county.
64CSR116
64CSR116
Of Contiguous Counties (include out-of-state) to you, list the starting annual salaries for EMS positions.
County Name EMVO Annual EMT Annual A-EMT Annual Paramedic S S S S County Demographics 2020 County Population_____________ County Fiscal Year Beginning Month___________ Current Population Estimate____________ Presence of EMS Specific Levy___Yes No If Yes, list the formal name of the EMS levy as listed on ballots____________________________________ If Yes, when was levy last renewed or enacted (if on first election cycle)______________ List your county’s overall levy rate verses the state maximum rate as a percentage_____% Are there cities, towns, or municipalities in the county who will have budget excesses this FY?Yes No Please include the most recent, voter approved levy order or special fee order as addendum Ambulance Response Information Total 911 request for ambulance service for last calendar year_______ Total number of WV Licensed Ambulance Transporting Agencies in county _____________ Total number of Active EMS Personnel_________________________ Total EMVO_____Total EMT Total Advanced- EMT Total Paramedic__________ Current New Hire Pay Rates (annual)
EMVO $__________ EMT$__________ Advanced-EMT$_________ Paramedic$____________ Are/Is the agency(ies) serving your county “short staffed” _____Yes _________No If yes, indicate the number of positions in each category that your county is short (Dedicated to 911 response only)
Total EMVO_____Total EMT Total Advanced- EMT Total Paramedic__________ Crisis Response Team Does your county have an organized Crisis Response Team specifically geared toward first responders including, but not limited to, EMS? Yes No If Yes, number of team members currently trained and deployable If No, Do you have plans to implement a Crisis Response Team? Yes No If Yes, Date team will be operational_ Team Liaison Name_____________________ Cell________ Please list each additional team members and their contact information individually as an addendum County Commission Signatures County Commission President County Commissioner County Commissioner County Commission Signatures County Commission President County Commissioner County Commissioner
Series 15 Cross-Connection Control and Backflow Prevention
W. Va. Code R. § 64-15-1 General
1.1. Scope. -- This legislative rule governs cross-connection control and backflow prevention for public water systems. This rule should be read in conjunction with W. Va. Code §16-1-9, §16-1-9a, §16-1-17, and §16-1-18.
1.2. Authority. -- W. Va. Code §16-1-4 and §16-1-9a.
1.3. Filing Date. -- March 27, 2024.
1.4. Effective Date. -- March 27, 2024.
1.5. Sunset Provision. -- This rule shall terminate and have no further force or effect on August 1, 2029.
W. Va. Code R. § 64-15-2 Application and Enforcement
2.1. Application. -- This legislative rule applies to any owner, operator, or customer of a public water system.
2.2. Enforcement. -- This rule is enforced by the Commissioner of the Bureau for Public Health.
W. Va. Code R. § 64-15-3 Definitions
3.1. Air Gap Separation. -- A physical separation between the free-flowing discharge end of a water supply pipe and the flood level rim of a vessel open to the atmosphere having a minimum unobstructed vertical distance between the supply pipe equal to twice its inside diameter or one inch, whichever is greater.
3.2. Approved. -- Accepted by the Commissioner as being suitable for the proposed use.
3.3. Approved Backflow Prevention Assembly. -- A double check valve assembly, reduced pressure backflow prevention assembly, other devices or methods approved by the Commissioner for preventing backflow.
3.4. Auxiliary Water Supply. -- Any water source or system available within the building or premises other than the community public water system including, but not limited to, individual wells, springs, and cisterns. A private water storage tank supplied by a community public water system is considered an auxiliary water supply unless its design meets the most current minimum design standards required for storage tanks for community public water systems, and the water contained in them is potable.
3.5. Backflow. -- The flow of water or other liquids, mixtures, or substances into the distributing pipes of a potable supply of water from any source or sources other than its intended source. Backsiphonage is one type of backflow.
3.6. Commissioner. -- The Commissioner of the Bureau for Public Health or his or her designee.
3.7. Cross-Connection. -- Any physical connection or arrangement between two otherwise separate systems or sources, one of which contains potable water and the other either water, steam, gas, or chemical of unknown or questionable safety whereby there may be a flow from one system or source to the other, the direction of flow depending on the pressure differential between the two systems.
3.8. Degree of Hazard. -- The potential risk to health and potential adverse effects upon the public water system based on the probability of backflow occurring and the type or nature of the contaminant.
3.9. Double Check Valve Assembly. -- An arrangement or device consisting of two single, independently acting watertight check valves with connections for testing the water-tightness of each check valve.
3.10. Flood Level Rim. -- The edge of the vessel or receptacle from which water overflows.
3.11. Health Hazard. -- Any condition, device, or practice that in the judgment of the Commissioner creates or may create a danger to the health and well-being of the water customer.
3.12. Interchangeable Connection. -- An arrangement or device that allows the alternate but not simultaneous use of two sources of water.
3.13. Low-Suction Pressure Cut-Off Controller. -- An arrangement or device designed to shut off a pump when the pressure at the suction side of the pump falls below a specified level.
3.14. Person. -- An individual, partnership, association, syndicate, company, firm, trust, corporation, government corporation, institution, department, division, bureau, agency, or any entity recognized by law.
3.15. Potable Water. -- Water free from impurities in amounts sufficient to cause disease or harmful physiological effects, with bacteriological, chemical, physical, and radiological quality conforming to applicable regulations and standards of the bureau for public health.
3.16. Public Water System (PWS). -- Any water supply or system that regularly supplies or offers to supply water for human consumption through pipes or other constructed conveyances, if serving at least an average of 25 individuals per day for at least 60 days per year, or which has at least 15 service connections, and shall include: (1) Any collection, treatment, storage, and distribution facilities under the control of the owner or operator of the system that are used primarily in connection with the system; and (2) Any collection or pretreatment storage facilities not under the control of the owner or operator of the PWS that are used primarily in connection with the system. A PWS does not include a system that meets all of the following conditions: (1) Consists only of distribution and storage facilities and does not have any collection and treatment facilities; (2) Obtains all of its water from, but is not owned or operated by, a PWS that otherwise meets the definition; (3) Does not sell water to any person; and (4) Is not a carrier conveying passengers in interstate commerce.
3.17. Reduced Pressure Backflow Prevention Assembly. -- A device containing a minimum of two independently acting check valves, an automatically operated pressure differential relief valve located between the two check valves and watertight valves located at each end of the assembly, with connections for testing the operation of the device.
3.18. Severe Health Hazard. -- A hazard to the health of the user that could reasonably be expected to result in significant morbidity or death.
3.19. Unprotected Cross-Connection -- Any cross-connection with no approved backflow prevention assembly, air gap separation, double check valve assembly, or reduced pressure backflow prevention assembly installed.
3.20. Water Customer. -- The owner or person in charge of any building or premises supplied by or in any manner connected to a community public water system.
3.21. Water Service Line. -- A pipe or water line, with or without a meter and valves, through which the water customer conveys the water from the public water system to the initial point of use.
W. Va. Code R. § 64-15-4 Cross-Connections
4.1. No person shall install or maintain an unprotected cross-connection in a public water system.
4.2. The public water system shall not install a water service connection to any premises where a violation of subsection 4.1 of this rule exists.
4.3. After giving written notice to the water customer with an opportunity for administrative due process, the public water system shall discontinue water service to any premises:
4.3.1. Where an unprotected cross-connection or unauthorized connection exists;
4.3.2. Where a required backflow prevention method has been removed or bypassed; or
4.3.3. When the public water system is denied entry to the water customer’s premises to confirm compliance with this rule.
4.4. When the public water system finds deficiencies in a water customer’s premises, as listed in subsection 4.3 of this section, the public water system shall;
4.4.1. Ensure that the public water system ceases water service to those premises until the deficiencies are corrected; and
4.4.2. Notifies the owner, person occupying, or in charge of the premises of the findings and orders that the cross-connection be removed or that an approved backflow prevention method be installed prior to water service resuming.
W. Va. Code R. § 64-15-5 When Protection Is Required
5.1. The Commissioner or his or her designee may determine, upon conducting a risk assessment, that any water supply system must be equipped with a backflow prevention assembly to protect the health and sanitation of water, whether publicly or privately owned: Provided, That water supply systems shall not require a backflow prevention assembly unless any of the following are met:
5.1.1. It cross-connects with a sprinkler or fire suppression system;
5.1.2. It cross-connects with an auxiliary water source or water well;
5.1.3. It cross-connects with any fluid storage tank, tub, pool, or cistern 85 gallons or larger with a public water inlet that can be below the water level;
5.1.4. It cross-connects with a boiler system;
5.1.5. It cross-connects with any land irrigation system; or
5.1.6. The property serviced by the public water supply is a funeral home or mortuary, restaurant, dry cleaner, medical facility, beauty and nail salon, car wash, multi-tenant retail space, commercial building three stories or taller, or commercial space with a dedicated fire service/sprinkler system, industrial facility, salvage and/or wastewater facility, food processing facility, recycling facility where cross-connected to the public water supply, correctional facility, or any other customer using chemicals harmful to human health that are cross-connected to the public water supply.
W. Va. Code R. § 64-15-6 Type of Protection and Circumstances When Protection Is Required
6.1. The type of protection required under this rule depends on the degree of hazard that exists or may exist, as determined by the Commissioner, or his or her designee, and shall involve the installation of:
6.1.1. An approved air gap separation when the Commissioner, or his or her designee, determines that contamination with substances could cause a severe health hazard;
6.1.2. An approved air gap separation or approved reduced pressure principle backflow prevention assembly when the Commissioner, or his or her designee, determines that contamination with substances could cause a health hazard; or
6.1.3. An approved double-check valve assembly, approved reduced pressure principle backflow prevention assembly, or an approved air gap separation when the Commissioner, or his or her designee, determines that contamination with substances could degrade the water quality of the public water system.
6.2. When the Commissioner, or his or her designee, does not approve any point of connection between a public water system and an auxiliary water supply, the water customer shall install an approved air gap separation or an approved interchangeable connection with a reduced backflow prevention assembly.
6.3. When a water customer installs a booster pump on the premises served by a public water system, or on the service line to the premises, the customer shall install a check valve on the discharge and a low-suction pressure cut-off controller designed to shut off the booster pump when the pressure in the service line on the suction side of the pump drops to 20 pounds per square inch gauge or less.
6.4. On premises where backflow prevention assemblies are required by this rule, and the public interest requires continuous uninterrupted service, the water customer shall install two approved backflow prevention assemblies in parallel and shall properly valve them to permit continuous operation, or service to the premises shall be from two separate water service lines each protected by an approved backflow prevention assembly.
6.5. Water customers that are open to the public shall be required to install internal backflow prevention methods as part of the public water system’s approved backflow prevention program in section 8 of this rule.
W. Va. Code R. § 64-15-7 Backflow Prevention Assemblies
7.1. The Commissioner, or his or her designee, shall approve installation of an approved backflow prevention assembly at a location and in a manner that best facilitates testing and servicing in accordance with the approved cross connection and backflow prevention program in section 8.2. of this rule.
7.2. The water customer shall purchase, install, maintain, and test any backflow prevention assembly according to this rule.
7.3. When any approved backflow prevention assembly is found to be defective, the water customer shall immediately notify the public water system of any defect and within 10 days shall repair, overhaul, replace, and test the assembly again at the water customer’s expense.
W. Va. Code R. § 64-15-8 Plans, Surveys, Investigations, and Testing
8.1. The water customer shall provide the public water system with all drawings, plans, specifications, and other data related to the backflow prevention assemblies so that the public water system can ensure the water customer’s compliance with this rule.
8.2. The public water system shall establish a cross-connection and backflow prevention program approved by the Commissioner.
8.3. The water customer shall furnish information on water use practices for facilities within the water customer’s premises, including plumbing diagrams, drawings, or plans, at the request of the public water system.
8.4. The water customer on any premises that under this rule requires the installation of backflow prevention assemblies is responsible for getting the assemblies inspected and for the cost of the required inspections.
8.4.1. The water customer shall ensure that a person certified by the Commissioner as a certified backflow assembly tester inspects and tests the backflow prevention assemblies upon installation and at least every 12 months after that; and
8.4.2. The certified backflow assembly tester shall provide records of all inspections and tests to the public water system within 15 days of the inspection or test.
8.5. The public water system shall maintain records of all inspections, surveys, tests, and corrective actions taken for a period of at least two years and provide the information to the Commissioner upon request.
8.6. The public water system shall request permission from a potential water customer to inspect the premises and dwellings formerly served by individual wells when the public water system believes unprotected cross-connections may exist. If the potential water customer does not allow the inspection, the refusal will be grounds not to supply water service.
8.7. No provisions of this rule shall relieve the water customer of the responsibility for conducting surveys of water use practices on his or her premises to determine whether there are actual or potential unprotected cross-connections.
8.8. Requirements of this rule shall be in accordance with all applicable guidelines contained in the West Virginia Bureau for Public Health Manual, EW-114, “Cross-Connection and Backflow Prevention Manual,” 2002.
W. Va. Code R. § 64-15-9 Enforcement
9.1. This rule is enforced under W. Va. Code §16-1-6, §16-1-9, §16-1-9a, §16-1-17, §16-1-18, and other applicable code provisions.
W. Va. Code R. § 64-15-10 Penalties
10.1. Any person who violates any provision of this rule or orders issued under this rule is subject to injunction, criminal prosecution, and criminal, civil, and administrative fines, all as provided in W. Va. Code §16-1-9, §16-1-9a, §16-1-17, and §16-1-18.
W. Va. Code R. § 64-15-11 Administrative Due Process
11.1. Those persons adversely affected by the enforcement of this rule may request a contested case hearing in accordance with the Bureau for Public Health procedural rule, Rules of Procedure for Contested Case Hearings and Declaratory Rulings, 64 CSR 1.
Series 16 Recreational Water Facilities
W. Va. Code R. § 64-16-1 General
1.1. Scope. -- This legislative rule establishes the minimum requirements for the design, construction, management and operation of recreational water facilities. The W. Va. Code is available in public libraries and on the Legislature’s web page, http://www.legis.state.wv.us/.
1.2. Authority. -- W. Va. Code §§16-1-4, 16-1-6 and 16-1-17.
1.3. Filing Date. -- April 18, 2007.
1.4. Effective Date. -- April 18, 2007.
1.5. Repeal and Replacement of Former Rules. -- This legislative rule repeals and replaces Division of Health rule 64CSR16, “Recreational Water Facilities”, effective July 1, 2002.
1.6. Applicability. -- This rule applies to the owners and operators of recreational water facilities.
1.7. Enforcement. -- This rule is enforced by the Commissioner of the Bureau for Public Health.
W. Va. Code R. § 64-16-2 Definitions
2.1. Available Qualified Water Facility Operator - a person who can be reached by telephone within thirty (30) minutes, and can be on site within sixty (60) minutes of notification, and visits the recreational water facility a minimum of one (1) time per week during the period of operation, as this term is used in section 9.1. of this rule.
2.2. Bathing Beach. -- An organized and controlled bathing place located on a natural stream, pond or lake, or on an artificial pond or lake which is formed by impounding a natural waterway.
2.3. Commissioner -- The Commissioner of the Bureau for Public Health or his or her designee.
2.4. Fecal Accident. -- The release of visible fecal matter into the water of a recreational water facility.
2.5. First Aid Kit. -- A packaged set of materials used for emergency treatment of injured or sick persons before professional medical care is available that includes a minimum of: adhesive compresses or band-aids of various sizes; adhesive tape; eye dressing pads (4" x 4" and 3" x 3"); gauze pads (4" x 4" and 3" x 3"); roller gauze (2", 3" and 4" widths); scissors; tweezers; triangular bandages; cold packs; personal protective equipment, including latex or other impermeable gloves; and resuscitation masks with one-way valves.
2.6. Operator. -- A person responsible for the operation of a recreational water facility.
2.7. Patron. -- A customer, client, or paying or non-paying guest at a recreational water facility.
2.8. Permit. -- A written document issued by the Commissioner giving a designated person permission to establish, construct, renovate, or operate a recreational water facility.
2.9. Person. -- An individual, city, town, partnership, association, company, corporation, government agency, institution, apartment, motel, country club, camp, or any other legal entity.
2.10. Private Residential Swimming Pool -- An indoor or outdoor structure, chamber, or tank containing a body of water for swimming, diving, or bathing located at a single residential dwelling that houses no more than three families and that is used exclusively by the residents and their non–paying guests.
2.11. Qualified Water Facility Operator. -- An individual who has passed a recognized Certified Pool Operator certification course, such as those offered by the National Spa and Pool Institute, the YMCA, or an equivalent course approved by the Commissioner. 2.11a. Recreational Water Facility. -- A body of water, under the control of a person, which has been modified, improved, constructed or installed for the purpose of public swimming or bathing. It includes, but is not limited to, bathing beaches; swimming, wading, and diving pools; water slides, spray pools, lazy rivers, and wave pools; spas, hot tubs, therapeutic pools, hydrotherapy pools, and whirlpools; facilities operated by communities, subdivisions, apartment complexes, condominiums, clubs, camps, schools, institutions, parks, mobile home parks, hotels, and similar recreational and public facilities. A recreational water facility does not include a private residential swimming pool as defined in this rule.
2.12. Shallow End. -- The part of a recreational water facility that has a depth of five (5) feet or less.
2.13. Spa. -- A unit designed for recreational use, including a hot tub, that is not drained, cleaned, or refilled for each user, and that may include hydrojet circulation, hot water, or air induction bubbles.
2.14. Swimming Pool. -- An artificial basin, chamber, or tank intended to be used for swimming, diving, therapy, competition, instruction, or recreational type bathing. The term does not include residential or individual therapeutic tubs or tanks.
2.15. Wading Pool. -- A small, shallow swimming pool not more than twenty-four (24) inches deep intended to be used for wading.
2.16. Wave Pool. -- A swimming pool designed for the purpose of producing wave action in the water.
W. Va. Code R. § 64-16-3 Construction Permit
3.1. A person shall not establish, construct or renovate a recreational water facility without first obtaining a construction permit from the Commissioner.
3.2. The applicant shall submit four (4) sets of completed applications, plans and specifications to the Commissioner for review and approval at least forty-five (45) days prior to the date on which he or she requests that the construction permit takes effect.
3.3. The applicant shall submit a written permit application on a form obtained from the Commissioner. The application, plans, and specifications shall include, but not be limited to:
3.3.a. Vicinity and site plans;
3.3.b. Detailed construction drawings;
3.3.c. Water source and treatment detail; and
3.3.d. Specifications for filtration, chlorination, testing equipment and other pertinent factors necessary for a complete operative system.
3.4. The Commissioner may suspend or revoke a construction permit if a person fails to comply with the provisions of the permit or this rule.
3.5. The Commissioner shall deny a construction permit if the information on the application form is incomplete, inaccurate, false or misleading, or indicates that the applicable provisions of this rule cannot be met.
3.6. A person whose application for a construction permit has been denied, or whose permit has been suspended or revoked, may submit a written petition to the Commissioner requesting a hearing on the matter, and the Commissioner shall grant a hearing on the matter within ten (10) days after he or she has received the petition.
3.7. The recreational water facility shall be constructed or renovated in accordance with the plans and specifications approved by the Commissioner, unless the Commissioner grants written approval for a deviation from the approved plans and specifications.
W. Va. Code R. § 64-16-4 Operating Permit
4.1. A person shall not in any manner conduct, control, manage, maintain, or operate a recreational water facility without obtaining an operating permit from the Commissioner.
4.2. The applicant shall submit to the Commissioner a written operating permit application on a form obtained from the Commissioner and signed by the applicant.
4.3. The applicant shall submit to the Commissioner an application for an operating permit at least fifteen (15) days before the operation of the recreational water facility is scheduled to begin.
4.4. The Commissioner shall deny a permit if the information on the application form is incomplete, inaccurate, false, or misleading, or indicates that the applicable provisions of this rule cannot be met.
4.5. A person shall comply with the applicable provisions of this rule in order to receive and retain an operating permit.
4.6. Recreational water facilities that are in operation on the date this rule becomes effective, and that meet all applicable prior rules, are eligible for a permit to operate. Construction, modification, installation, or renovations proposed for a recreational water facility after the effective date of this rule shall comply with all applicable provisions of this rule.
4.7. Permits are not transferable and become invalid immediately upon a change of ownership, suspension or revocation.
4.8. In the event of a proposed or an actual change in ownership of a recreational water facility, an applicant shall submit an application for an operating permit to the Commissioner at least fifteen (15) days prior to the date of the proposed or actual change.
4.9. The Commissioner may suspend or revoke a permit if he or she finds that the recreational water facility is in violation of this rule.
4.10. The Commissioner shall not reinstate an operating permit until he or she determines by an inspection that the recreational water facility is in compliance with all applicable provisions of this rule.
4.11. The operator shall prominently display the operational permit in a conspicuous place at the recreational water facility.
4.12. A person whose application for an operating permit has been denied, or whose permit has been suspended or revoked, may submit a written petition to the Commissioner requesting a hearing on the matter, and the Commissioner shall grant a hearing on the matter within ten (10) days after he or she has received the petition.
W. Va. Code R. § 64-16-5 Inspections, Closure Orders
5.1. The Commissioner shall inspect each recreational water facility not less than two (2) times per year.
5.2. The owner, operator, or person in charge of a recreational water facility shall provide the Commissioner immediate access to the premises for the purpose of inspection, and shall provide requested information for the inspection.
5.3. When the Commissioner inspects a facility and finds that the recreational water facility is not in compliance with any of the provisions of this rule, he or she shall provide the operator with a written inspection report noting the violations. The operator shall correct the violations within the time frame specified in the inspection report.
5.4. The Commissioner may order the immediate closure of a recreational water facility when he or she finds:
5.4.a. A condition at the recreational water facility that endangers the life, health, or safety of the patrons or employees;
5.4.b. Excessive turbidity as determined by a standard clarity sight disk; or
5.4.c. A disinfectant residual that is less than that permitted under the provisions in subdivisions 7.1.d. and 7.1.e. of this rule.
5.5. An issued closure order shall remain in effect until the Commissioner determines that necessary corrections have been made.
W. Va. Code R. § 64-16-6 Design, Construction
6.1. A recreational water facility that is designed, constructed, or renovated after the effective date of this rule shall comply with the National Spa and Pool Institute ANSI/NSPI-1 2003 Standard for Public Swimming Pools, ANSI/NSPI-2 1999 Standard for Public Spas, ANSI/IAF-9 2005 Standard for Public Water Parks and ANSI/APSP-7 2006 National Standard for Suction Entrapment Avoidance in Swimming Pools, Wading Pools, Spa, Hot Tubs, and Catch Basins. These standards are available through the internet at: http://www.nspi.org/home.
W. Va. Code R. § 64-16-7 Water Quality
7.1. Disinfection.
7.1.a. A recreational water facility, with the exception of bathing beaches, shall be disinfected continuously by the use of chemical feed equipment.
7.1.b. A recreational water facility may not use hand batch feeding of disinfecting chemicals except when performing super-chlorination or shocking.
7.1.c. Disinfecting materials and methods shall:
7.1.c.1. Be used only with the approval of the Commissioner.
7.1.c.2. Not create an undue safety hazard;
7.1.c.3. Be handled, stored, and used according to directions;
7.1.c.4. Be compatible for use with other chemicals commonly used in pool water treatment, or be clearly identified as having a use limitation;
7.1.c.5. Not impart toxic properties to the water when used according to directions; and
7.1.c.6. Provide an effective residual which can be easily and accurately measured by a field test procedure.
7.1.d. When chlorine is used as the disinfectant, the recreational water facility shall maintain a free chlorine residual of at least one (1) milligram per liter (mg/l) to a maximum of five (5) milligrams per liter (mg/l) throughout.
7.1.e. When bromine is used as the disinfectant, the recreational water facility shall maintain a residual of at least two (2) milligrams per liter (mg/l) to a maximum of five (5) milligrams per liter (mg/l) throughout.
7.1.f. Disinfecting materials or methods other than chlorine and bromine:
7.1.f.1. Shall be approved by the Commissioner prior to being used;
7.1.f.2. Shall be registered as a bactericidal agent by the U.S. Environmental Protection Agency; and
7.1.f.3. May be used if they provide a satisfactory residual which is easily measured and is as effective under conditions of use as the chlorine concentrations required in this rule.
7.1.g. When cyanuric acid is used as a stabilizer, it must be maintained at a level between ten (10) and one hundred (100) milligrams per liter (mg/l).
7.2. Chemical Requirements.
7.2.a. The water in a recreational water facility, except for bathing beaches, shall conform to the chemical limits specified in Division of Health rule, “Public Water Systems,” 64CSR3.
7.2.b. Bathing beach water shall conform to the standards prescribed for Category A in Appendix E of the Environmental Quality Board’s rule, “Requirements Governing Water Quality Standards,” 46CSR1.
7.3. Bacteriological Requirements.
7.3.a. The Commissioner shall collect a series of water samples for bacteriological analysis from each recreational water facility. A series shall consist of one (1) water sample each from the deep end, the shallow end, and the wading pool, if applicable, or two (2) water samples from different locations of a bathing beach.
7.3.b. Within thirty (30) days of the opening of seasonal recreational water facilities, the Commissioner shall collect not less than one (1) series of samples, and during the same season of operation, he or she shall collect not less than one (1) additional series of samples. For indoor recreational water facilities, the Commissioner shall collect not less than one (1) complete series of samples every six (6) months.
7.3.c. A laboratory approved by the Commissioner shall examine water samples after the residual disinfectant in the samples is deactivated.
7.3.d. The Commissioner shall collect water samples while the recreational water facility is in use.
7.3.e. If laboratory results of a water sample from a recreational water facility, except for bathing beaches, indicate the presence of coliform organisms:
7.3.e.1. The operator shall super-chlorinate the recreational water facility, and the water shall be retested immediately; and
7.3.e.2. The operator shall investigate the cause of the unsatisfactory sample and initiate, or cause to be initiated, corrective action.
7.3.f. If laboratory results of a water sample from a bathing beach indicate that e. coli exceeds two hundred thirty-five (235) per one hundred (100) milliliters in any single sample:
7.3.f.1. The bathing beach shall cease operation and the water shall be retested immediately;
7.3.f.2. The operator shall investigate the cause of the unsatisfactory sample and initiate, or cause to be initiated, corrective action.
7.4. pH and Alkalinity Control.
7.4.a. A recreational water facility, except for bathing beaches, shall maintain the pH of the water in an alkaline condition of not less than seven point two (7.2) nor greater than seven point eight (7.8) at any time the facility is in use.
7.4.b. A recreational water facility that is equipped with gaseous chlorination feeders shall provide a mechanical chemical feeder to continuously control the pH. Hand batch feeding of chemicals to control pH is prohibited.
7.4.c. A recreational water facility, except for bathing beaches, shall maintain the total alkalinity at a level between sixty (60) and one hundred eighty (180) milligrams per liter (mg/l) as calcium carbonate.
7.5. Water Clarity.
7.5.a. A recreational water facility, except for bathing beaches, shall maintain sufficient water clarity to allow the main drain or a six (6) inch black disk on the bottom of the deepest part of the recreational water facility to be readily visible when viewed from the recreational water facility deck.
7.5.b. The operator shall use Table 64-15 C at the end of this rule as a guideline to assist him or her in maintaining optimum water quality at the recreational water facility.
W. Va. Code R. § 64-16-8 Control Tests and Operation Records
8.1. Except for bathing beaches, recreational water facilities shall have available at all times approved testing equipment for determining pH, free chlorine, total chlorine, total alkalinity, and other tests required by the Commissioner.
8.2. Equipment used for testing free or total chlorine shall use the DPD (N, N-Diethyl-P-Phenylenediamine) method. Test strips or Oxidation Reduction Potential (ORP) may be used as a measuring parameter, but shall not be used when registering required readings on daily operational reports required by the Commissioner.
8.3. The operator shall maintain for a minimum of one (1) year written results of required tests, attendance data, number of hours of equipment operation, and any other information required by the Commissioner.
8.4. The operator shall submit on forms obtained from the Commissioner a weekly summary of operation and tests to the Commissioner.
8.5. Except for bathing beaches, the operator shall conduct tests to determine the pH and free chlorine residual of the water not less than twice daily, and record the results on the weekly summary required under subsection 8.4 of this section.
8.6. The operator shall properly maintain test kits in good condition. All test reagents must be replaced at the beginning of a new testing season for a seasonal facility, as required by the test kit manufacturer, and whenever any reagent is found to be defective, but in no case may a reagent be used over one (1) year from the date of purchase. Only those reagents manufactured for the test kit in use shall be used.
8.7. Except for bathing beaches, when a control test indicates that the free chlorine residual is less than one (1) milligram per liter (mg/l), the recreational water facility shall cease operations until the free chlorine level is one (1) milligram per liter (mg/l) or above.
8.8. Except for bathing beaches, when a control test indicates that the free bromine residual is less than two (2) milligrams per liter (mg/l), the recreational water facility shall cease operations until the free bromine level is two (2) milligrams per liter (mg/l) or above.
W. Va. Code R. § 64-16-9 Supervision of Patrons
9.1. Except for bathing beaches, a qualified water facility operator shall be available for consultation at all times the recreational water facility is open for use.
9.2. The operator shall have the authority to:
9.2.a. Exclude from the premises any patron who does not follow the safety and sanitation rules; and
9.2.b. Evacuate the facility as needed to protect the health and safety of the employees.
9.3. The operator shall supervise the patrons and enforce the following rules:
9.3.a. An individual shall not urinate, defecate, spit, spout water, or blow his or her nose in the water.
9.3.b. Patrons who have open sores, or an infectious disease that is transmissible by water may not use the recreational water facility.
9.3.c. Patrons and the apparel they wear in the water shall be visibly clean.
9.3.d. Children who are not toilet trained shall wear tight fitting plastic underwear that will prevent leakage, or use other appropriate apparel approved by the Commissioner.
9.3.e. Patrons under the influence of drugs or alcohol or exhibiting disruptive behavior are not permitted in the recreational water facility.
9.3.f. Except for service animals, animals shall not be allowed in the recreational water facility.
9.3.g. Food, drink, gum, and tobacco may be used only in designated and controlled areas.
9.3.h. Glass containers or other materials that might create hazardous conditions or interfere with efficient operation of the facility are not allowed.
9.3.i. Diving from the deck shall be permitted only in designated areas where the water is more than five (5) feet in depth.
9.4. The recreational water facility shall prominently post the rules applicable to patron behavior so as to be readily visible to the patrons.
W. Va. Code R. § 64-16-10 Safety Requirements
10.1. A recreational water facility shall have a Shepherd’s crook and reach pole available for use.
10.2. At recreational water facilities with lifeguards, the facility shall provide one (1) rescue tube for each lifeguard on duty that is readily accessible for emergency use.
10.3. At recreational water facilities without lifeguards, the facility shall provide a minimum of one (1) unit of life saving equipment available for patron use as approved by the Commissioner.
10.4. A recreational water facility shall maintain all equipment in good repair.
10.5. A recreational water facility shall be equipped with a readily available, fully stocked first aid kit according to the provisions in subsection 2.5 of this rule.
10.6. Operators shall not permit employees who have open sores or an infectious disease that is transmissible by water in the water or to serve as lifeguards.
10.7. Each lifeguard on duty shall have immediate access to personal protective equipment including, but not limited to, a resuscitation mask and latex or other impermeable gloves.
10.8. Except for spas, hot tubs, and whirlpools, if a recreational water facility requires an admission fee such as a gate receipt, annual pass, or membership dues, or is used by an organized camp or a child care center, the facility shall provide certified lifeguards on duty at all times the facility is open according to the following:
10.8.a. The number of lifeguards required shall be determined by the size of the recreational water facility and the number of patrons as described in Table 64-16 B at the end of this rule. The operator may request in writing from the Commissioner a variance in the number of lifeguards required.
10.8.b. A lifeguard shall have a current life guarding certificate from the American Red Cross, Ellis and Associates, the YMCA, or an equivalent organization approved by the Commissioner.
10.8.c. A lifeguard shall have a current cardiopulmonary resuscitation (CPR) certificate from the American Red Cross, the American Heart Association, the National Safety Council, or an equivalent organization approved by the Commissioner.
10.8.d. A lifeguard shall have a current first aid certificate, equal to or better than the American Red Cross Standard First Aid or National Safety Council First Aid Certification or an equivalent organization approved by the Commissioner.
10.8.e. Parents or accompanying adults shall not leave children unattended in a wading pool.
10.8.f. The employment of lifeguards is recommended, but not mandatory at:
10.8.f.1. Mobile home parks, travel trailer camps, hotels, motels, apartment complexes, condominiums or private residential communities that have recreational water facilities that are available for use only to the residents; or
10.8.f.2. Mobile home parks, travel trailer camps, hotels, motels, apartment complexes, condominiums or private residential communities that have recreational water facilities with a depth of five (5) feet or less.
10.8.g. If the facility employs no lifeguards, the management shall post a sign in a prominent location near the recreational water facility stating "Warning: No lifeguard on duty – All persons under the age of fourteen (14) must be accompanied by an adult”.
10.9. Each recreational water facility shall have a blood-borne pathogen plan based on the Occupational Safety and Health Administration’s standards.
10.10. Telephone service shall be available within one hundred (100) feet of the recreational water facility, and emergency phone numbers for rescue agencies shall be posted.
10.11. Each recreational water facility shall have a written emergency action plan that includes all life-threatening emergencies, non-life-threatening emergencies, chemical spills, and environmental emergencies.
10.12. The recreational water facility shall take appropriate measures to avoid entrapment of patrons on drains.
10.12.a. Pools with single suction outlets must meet National Spa and Pool Institute ANSI/NSPI-1 2003 Standard for Public Swimming Pools, public spa suction outlets must meet ANSI/NSPI-2 1999 Standard for Public Spas, and Public Water Park suction outlets must meet ANSI/IAF-9 2005 Standard for Public Water Parks and ANSI/APSP-7 2006 National Standards for Suction Entrapment Avoidance in Swimming Pools, Wading Pools, Spa, Hot Tubs, and Catch Basins. These standards are available through the internet at: http://www.nspi.org/home.
10.12.b. Spas constructed, installed, or modified after July 1, 2002 shall provide an emergency shut-off switch and an audible alarm placed within twenty (20) feet of the spa.
10.13. Recreational water facilities shall comply with applicable provisions of the State Fire Commission’s rule, “Fire Code,” 87CSR1.
10.14. The patron load shall be determined by the National Spa and Pool Institute ANSI/NSPI-1 2003 Standard for Public Swimming Pools or the most current design standard.
W. Va. Code R. § 64-16-11 Routine Maintenance and Operation
11.1. The following requirement applies to all recreational water facilities:
11.1.a. A recreational water facility shall keep deck areas, sidewalks and other areas around the recreational water facility and bath house clean.
11.2. The following requirements apply to all recreational water facilities except bathing beaches:
11.2.a. The operator shall remove visible debris from the bottom of the recreational water facility every twelve (12) hours or as often as necessary to maintain visibility and maximize safety.
11.2.b. The operator shall maintain the water surface of a recreational water facility free of visible scum and floating matter.
11.2.c. The operator shall drain the recreational water facility as necessary for inspection, cleaning, or repair.
11.2.d. The operator shall ensure that the recreational water facility operates the water treatment equipment twenty-four (24) hours per day.
11.3. A recreational water facility shall ensure that ventilation for indoor recreational water facilities meets ANSI/ASHRAE Standard 62.1-2004 Ventilation for Acceptable Indoor Air Quality or the most current design standard. This standard is available through the internet at: http://www.ashrae.org.
W. Va. Code R. § 64-16-12 Bathhouses, Concessions, and Other Appurtenant Facilities
12.1. A recreational water facility shall provide toilets, lavatories, showers and drinking fountains as required by the State Fire Commission rule, “State Building Code,” 87CSR4.
12.2. A recreational water facility shall keep bathhouses, clothing storage facilities, toilet facilities, shower facilities and other appurtenant facilities in good repair and in a clean, sanitary condition.
12.3. A recreational water facility shall ensure that a supply of toilet tissue is available at each toilet.
12.4. A recreational water facility shall provide hand cleanser and an approved hand drying device at each lavatory or group of adjacent lavatories.
12.5. A recreational water facility shall ensure that hot and cold running water is supplied from mixing faucets for showers and lavatories, or that tempered water is provided in lieu of hot and cold running water supplied from mixing faucets.
12.6. A recreational water facility that provides a concession stand shall operate the concession stand in accordance with Division of Health rule, “Food Establishments,” 64CSR17.
12.7. A recreational water facility shall provide a placard in the filter room that lists the water volume and gallons per minute of water needed for the pool’s turnover rate.
W. Va. Code R. § 64-16-13 Compliance
13.1. Except for bathing beaches, if any of the following events described in subdivisions 13.1.a through 13.1.i of this section occur while a recreational water facility is in use, the operator shall close the recreational water facility and take the corrective action specified in Table 64-16 A at the end of this rule before reopening the facility:
13.1.a. The free chlorine residual of water is less than one (1) milligram per liter (mg/l).
13.1.b. The pH of water is greater than seven point eight (7.8).
13.1.c. The pH of water is less than seven point two (7.2).
13.1.d. An inadequate number of lifeguards or lifesaving equipment is provided as required under this rule.
13.1.e. An accident occurs that causes a lifeguard to leave his or her station or results in the discharge of body fluids into the water.
13.1.f. The free bromine residual is less than two (2) milligrams per liter (mg/l).
13.1.g. A failure of the circulation pump or disinfectant feed equipment occurs.
13.1.h. A fecal accident occurs or blood or vomitus is released into the water.
13.2. Except for bathing beaches, the operator shall close only the affected area of the recreational water facility if the water clarity is not in compliance with subsection 7.5 of this rule.
13.3. At a bathing beach, if an inadequate number of lifeguards or lifesaving equipment is provided or an accident occurs that causes a lifeguard to leave his or her station, the operator shall close the bathing beach immediately and not reopen the facility until it is in compliance.
13.4. The operator shall maintain a written record of each event, including the date the event occurred, a description of the event, and the corrective action taken.
W. Va. Code R. § 64-16-14 Penalties
14.1. Any person who violates any provision of this rule or orders issued pursuant to this rule is subject to a fine of not more than five hundred dollars ($500), as provided under W. Va. Code §16-1-18.
W. Va. Code R. § 64-16-15 Administrative Due Process
15.1. Those persons adversely affected by the enforcement of this rule desiring a contested case hearing to determine any rights, duties, interests or privileges shall do so in a manner prescribed in the Division of Health’s rule, “Rules of Procedure for Contested Case Hearings and Declaratory Rulings, 64CSR1.”
Table 64-16 A - Closure RequirementsTable 64-16 A - Closure Requirements Closure Event Corrective Action Required A. Free Chlorine = less than 1.0 pm Close the facility. Determine the cause. Make repairs or corrections.
B. pH of water = greater than 7.8 Close the facility. Determine the cause. Make repairs or corrections.
C. pH of water = less than 7.2 Close the facility. Determine the cause. Make repairs or corrections.
D. Inadequate lifeguards or lifesaving equipment Close the facility until the required number of lifeguards and lifesaving equipment are provided.
E. Accident Resulting In:
Lifeguard leaving station OR Body fluids discharged into water Close facility until lifeguard returns to station.
Follow fecal accident cleanup procedures outlined below in item I if blood or feces are discharged into the water.
F. Water Clarity Unsatisfactory (Main drain or 6 inch black disk in the deepest water on the bottom of a pool or spa not visible from the adjacent deck)
Close the affected area until the main drain or a six (6) inch black disk in the deepest water on the bottom of a pool or spa is visible from the adjacent deck.
Determine cause. Make repairs or corrections.
G. Free bromine = less than 2.0 ppm Close the facility. Determine the cause. Make repairs or corrections.
H. Equipment Failure - Main pump, disinfectant feed equipment, or main drain covers.
Close the facility immediately upon main pump failure. Close the facility when disinfectant feed equipment fails and free chlorine falls below 1.0 ppm or free bromine falls below 2.0 ppm. Repair equipment. Test and balance chemical parameters prior to re-opening the recreational water facility. Close facility if main drain covers are missing, loose, or broken. Replace, secure, or repair as required.
I. Fecal Accident or Release of Blood or Vomitus into Water * Follow Cleanup Procedure A if:
A formed stool, visible blood, or vomit is discharged into the water.
Follow Cleanup Procedure B if:
A loose stool (e.g. diarrheal fecal accident) is discharged into the water.
Evacuate patrons from all water contaminated with fecal material. Do not let anyone back into the water until all decontamination procedures are completed.
Remove as much fecal material as possible using a net or scoop and dispose of in a sanitary manner. Clean and disinfect the net or scoop (e.g. after cleaning, leave the net or scoop immersed in the pool during disinfection). VACUUMING STOOL AND VOMITUS FROM THE WATER IS NOT RECOMMENDED.
Proceed to procedure A or B as required.
Cleanup Procedure A 1. Raise free chlorine to 2 ppm, adjust pH to between 7.2-7.5, and maintain for at least 25 minutes before letting anyone back into the water.
- Ensure that the filtration system is operating during this entire process.
Cleanup Procedure B 1. Raise chlorine to one of the following concentrations, maintain for the corresponding time, and adjust pH to between 7.2-7.5:
a. 5ppm free chlorine for 32 hours;
b. 10 ppm free chlorine for 16 hours;
c. 15 ppm free chlorine for 12 hours;
d. 20 ppm free chlorine for 8 hours.
-
Ensure that the filtration system is operating during the entire process.
-
Backwash the filter thoroughly or clean the filter media after maintaining the required free chlorine concentration and time.
-
Adjust free chlorine concentration to less than 5 ppm before letting anyone back into water.
Cleanup Procedures A & B Establish a fecal accident log. Document each fecal accident by recording date and time of event, note whether formed stool or diarrhea, and note the chlorine levels at the time or observation of the event. Before allowing anyone back into the water, record the pH , the procedures followed in response to the fecal accident (including the process used to increase chlorine levels if necessary), and the contact time. * Current CDC guidelines Table 64-16 B - Lifeguard Requirements Number of Patrons in Water Water Surface Area in Square Feet Up to 2000 2001-4000 4001-6000 6001-8000 8001-10,000 10,000 + 1-30 31-60 61-90 91-120 121-150 151 + Table 64-16 C - Water Quality Guidelines Table 64-16 C - Water Quality Guidelines A. Disinfectant Levels 1. Free chlorine
1.0
2.0 -3.0
5.0 Chlorine should be maintained at this level continuously. Super-chlorinate regularly. See B-1 below.
- Combined chlorine
0.5 Eliminated by super-chlorination.
If too high, you may have:
Sharp chlorinous odors Eye burn Algae growth Bacteria growth 3. Bromine
2.0 2.0-3.0
5.0 Consult health dept. officials before use.
B. Chemical Values 1. pH
7.2
7.5
7.8 Low chlorine efficiency Scale formation Increased chemical demand Cloudy water Eye discomfort Rapid dissipation of chlorine Eye discomfort Plaster/concrete etching Corrosion of metals 2. Total alkalinity as CaCO3 80-100 or 120 Increased scaling potential Cloudy water pH maintained too high Corrosion tendency pH bounce 3. Undissolved solids (Turbidity)
Chlorine level may be too low Filtration system may be inoperative May lead to drowning due to decreased visibility 4. Dissolved solids Chlorine may be less effective Salty taste Add fresh water to reduce solids Dull water Chemical balance difficult to maintain Scaling may occur Total alkalinity may be too low Aggressive water B. Chemical Values (cont’d)
- Hardness, as CaCO3 mg/l Scaling may occur Water has bad “feel”
Short filter runs Plaster or concrete etching Corrosion may occur 6. Copper
0.3 Staining may occur Water may discolor Chlorine dissipates rapidly Filter may plug May indicate pH too low Corrosion may occur 7. Iron
0.2 Staining may occur Waste may discolor Chlorine dissipates rapidly Filter may plug 8. Manganese
0.05 Staining may occur C. Biological Values 1. Algae Super-chlorinate or shock treat facility Supplement with brushing and vacuuming Maintain adequate free chlorine residual Use approved algaecide according to label direction 2. Bacteria Refer to 64CSR3 If bacteria count exceeds health dept. requirements:
Super-chlorinate recreational water facility Follow proper maintenance procedures Maintain proper free chlorine residual D. Stabilizer 1. Cyanuric acid 30-50 May exceed health department regulations Chlorine residual rapidly destroyed by sunlight NOTE Stabilizer is not needed for indoor facilities and should not be used in hot water facilities. Cyanuric acid may titrate as Alkalinity.
E. Algaecides 1. Quaternary Not permitted in public recreational water facilities.
E. Algaecides (cont’d)
- Copper based (nonchelated)
0.1
0.2
0.3 Ineffective against some algae.
Consult health dept. officials before using.
May contribute to staining.
- Copper based (chelated)
0.1
1.0
3.0 Ineffective against some algae.
Consult health dept. officials before using.
May contribute to staining.
- Silver based
0.5
1.5
3.0 Precipitates with cyanuric acid.
Ineffective against some algae.
Consult health dept. officials before use.
F. Remedial Practices 1. Super- Chlorination When Combined Chlorine is 0.2 mg/l (ppm) or more * As needed 2. Required superchlorination /shock chlorine 10* *10 times combined chlorine reading.
Must be done when the facility is not in use.
May reopen when free chlorine is below 5.0 ppm.
-
Floccing Not Recommended Consult health dept. officials before using.
-
Water Replacement - Hot water facility Change water and clean monthly as a minimum, more frequently when heavy use and chemical treatment difficulties are experienced.
G. Temperature 1. Water temperature - Hot water facility Patron preference 104EF Excessive fuel requirement Increased chlorine use Increased scaling potential Patron discomfort Health threat to those with high blood pressure TOO LOW - Patron discomfort 2. Water temp. - Artificially heated 75 EF 90 EF 3. Air temperature Indoor facilities Water temp. minus 2EF Water temp. plus 8 EF Excluding hot water facilities.
H. Water Clarity 1. Turbidity Must be able to see main drain or six inch black disk on bottom of deepest part from the sidewall.
Chlorine level may be too low Filtration level may be inoperative May lead to drowning due to decreased visibility 64CSR16 64CSR16
Series 17 Food Establishments
W. Va. Code R. § 64-17-1 General
1.1. Scope. -- This legislative rule establishes the minimum requirements for the design, construction, management and operation of food establishments.
1.2. Authority. -- W. Va. Code §16-1-4 and §16-6-2.
1.3. Filing Date. -- March 30, 2023.
1.4. Effective Date. -- April 1, 2023.
1.5. Sunset Provision. -- This rule shall terminate and have no further force or effect on August 1, 2028.
1.6. Applicability. -- This rule applies to the owners and operators of food establishments.
1.7. Enforcement. -- This rule is enforced by the Commissioner of the Bureau for Public Health.
W. Va. Code R. § 64-17-2 Definitions
2.1. Commissioner. -- Commissioner of the Bureau for Public Health or his or her lawful designee.
2.2. Family Child Care Facility. -- Any facility that is used to provide nonresidential child care services for compensation for seven to 12 children, including children who are living in the household, who are under six years of age. No more than four of the total number of children may be under 24 months of age. A facility may be in a provider’s residence or a separate building.
2.3. Family Child Care Home. -- A facility that is used to provide nonresidential child care services for compensation in a provider’s residence. The provider may care for four to six children at one time including children who are living in the household, who are under six years of age. No more than two of the total number of children may be under 24 months of age.
2.4 Retail Food Store - Any place, structure, premise, vehicle, or any part thereof in which food is sold retail, offered for retail sale, or served not to be consumed on the premises. The term "retail food store" does not include establishments that handle only prepacked, non-potentially hazardous foods; roadside markets that offer only fresh fruits or fresh vegetables; or the delicatessen operation of a retail food store.
W. Va. Code R. § 64-17-3 Incorporation by Reference of Federal Model Food Code
3.1. The Federal Food Code, also known as the 2013 Recommendations of the United States Public Health Service, Food and Drug Administration, (hereinafter referred to as the “Food Code”) published by the U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, is incorporated by reference with the following exceptions:
3.1.a. Chapter 1, the definition of “food establishment” in paragraph 1-201.10(B) shall not be used for the purposes of this rule. In lieu thereof, the term “food establishment” is defined in section 4 of this rule;
3.1.b. The following shall be added to paragraph 2-102.12(A), “within one (1) year of the effective date of this rule.”;
3.1.c. Chapter 2, paragraph 2-102.12(B) may not be used for the purposes of this rule. The following applies: “This section does not apply to: (1) retail food facilities where only commercially prepackaged food is handled and sold, and (2) temporary food establishments.”;
3.1.d. The following shall be added to Chapter 3, paragraph 3-501.16(A)(2) “Within five years of the effective date of this rule, the refrigeration equipment in a retail food store used to hold cut leafy greens shall be repaired, upgraded, or replaced to maintain the cut leafy greens at a temperature of 5 C, (41 F) or less, if not already capable of maintaining the required temperature.”;
3.1.e. Chapter 3, paragraph 3-501.16(B) may not be used for the purposes of this rule. The following applies: “Eggs that have not been treated to destroy all viable Salmonellae shall be stored in refrigerated equipment that maintains an ambient air temperature of 5 C (41 F) or less.”;
3.1.f. In Chapter 3, paragraph 3-603.11(A), the word “milk” shall be deleted;
3.1.g. In Chapter 3, subparagraph 3-603.11(C)(3) the following applies: “Consuming raw or undercooked meats, poultry, seafood, shellfish, or eggs may increase your risk of foodborne illness, especially for children, elderly, immunocompromised individuals, and persons with certain medical conditions.”;
3.1.h. Chapter 6, section 6-501.115 is not applicable if the following conditions are met:
3.1.h.1. The dog is prohibited from entering any areas where food is being prepared;
3.1.h.2. The dog owner will be asked to leave, if a dog creates a nuisance;
3.1.h.3. The establishment is licensed as a private club, restaurant, coffee shop, brew pub, or micro distillery;
3.1.h.4. The establishment has liability insurance for dog-related incidents;
3.1.h.5. Dog accidents are cleaned and sanitized. Dog waste stations are available. A written procedure shall be established and posted concerning dog accident cleanup; and
3.1.h.6. Signage is present indicating that the establishment is dog friendly.
3.1.i. Chapter 8, section 8-102.10 and section 8-304.10 shall not apply;
3.1.j. Chapter 8, section 8-201.11 shall include the following sentence after subsection C: “All required plans shall be submitted at least 45 days prior to the start of construction, conversion, or remodeling.”;
3.1.k. Chapter 8, section 8-405.11 shall be deleted in its entirety and in lieu thereof the following language shall be inserted: 8-405.11 Timely Correction.
(A) Except as specified in ¶ (B) of this section, a PERMIT HOLDER shall at the time of inspection correct a violation of a PRIORITY ITEM or PRIORITY FOUNDATION ITEM of this Code and implement corrective actions for a HACCP PLAN provision that is not in compliance with its CRITICAL LIMIT.Pf (B) Considering the nature of the potential HAZARD involved and the complexity of the corrective action needed, the REGULATORY AUTHORITY shall agree to or specify a time frame, not to exceed:
(1) 72 hours after the inspection, for the PERMIT HOLDER to correct violations of a PRIORITY ITEM; or (2) 10 calendar days after the inspection, for the PERMIT HOLDER to correct violations of a PRIORITY FOUNDATION ITEM or HACCP PLAN deviations.
3.1.l. Chapter 8, part 8-6, and subparts 8-905 through 8-913 of Annex 1 shall not apply; and
3.1.m. Annex 1, section 8-904.10, shall include the following additional provision:
The commissioner may also summarily suspend a permit to operate a food establishment if:
3.1.m.1. The food establishment has three or more immediately uncorrectable priority items in violation at the time of inspection; or
3.1.m.2. The permit holder has been determined by the commissioner to have obstructed or hindered the commissioner in the proper discharge of his or her duties; and
3.1.m.3. Enforcement shall be in accordance with W. Va. Code §16-1-1 et seq. and §16-6-1, et seq.
3.2. The commissioner shall use Annexes 2 through 7 of the Food Code in the interpretation and application of this rule.
3.3. The Food Code is available on the internet at: http://www.fda.gov or as posted by the United States Food and Drug Administration.
W. Va. Code R. § 64-17-4 West Virginia Definition of Food Establishment
4.1. Food establishment -- An operation that stores, prepares, packages, serves, vends, or otherwise provides food for human consumption:
4.1.a. Such as a restaurant; satellite or catered feeding location; catering operation if the operation provides food directly to a consumer or to a conveyance used to transport people; market; vending location; conveyance used to transport people; institution; or food bank; and
4.1.b. That relinquishes possession of food to a consumer directly, or indirectly through a delivery service such as home delivery of grocery orders or restaurant takeout orders, or delivery service that is provided by common carriers;
4.2 Food establishment includes:
4.2.a. An element of an operation such as transportation vehicle or a central preparation facility that supplies a vending location or satellite feeding location unless the vending or feeding location obtains a permit to operate in accordance with part 8-3 of the Food Code;
4.2.b. An operation that is conducted in a mobile, stationary, temporary, or permanent facility or location, where consumption is on or off the premises, and regardless of whether there is a charge for the food; and
4.2.c. An operation that offers cooking demonstrations or instruction, with or without student participation, and the food is then consumed on or off premises.
4.3. Food establishment does not include:
4.3.a. An establishment that offers only prepackaged foods that are not time/temperature control for safety food and does not provide reusable tableware to the consumer;
4.3.b. A produce stand that only offers whole, uncut fresh fruits and vegetables;
4.3.c. A food processing plant including those located on the premises of a food establishment;
4.3.d. A kitchen in a private home if:
4.3.d.1. The food prepared in a kitchen in a private home for sale or service at a function such as a religious or charitable organization’s bake sale that is not time/temperature control for safety food (formerly “potentially hazardous food”(PHF)); and
4.3.d.2. If the consumer is informed by a clearly visible placard at the sales or service location that the food is prepared in a kitchen that is not subject to regulation and inspection by the commissioner;
4.3.e. An area where food that is prepared as specified in subdivision 4.3.d. of this subsection is sold or offered for human consumption;
4.3.f. A kitchen in a family child care home; or
4.3.g. A private home that receives catered or home-delivered food.
W. Va. Code R. § 64-17-5 Modified Requirements for Specific Types of Food Establishments
5.1. A domestic-type kitchen with residential-style equipment is acceptable in the following types of food establishments:
5.1.a. A family child care facility;
5.1.b. A boarding house or a residential care facility, such as a personal care home, a residential board and care facility, a group home, a halfway house, or a work release center, with a maximum capacity of 12 occupants; and
5.1.c. A bed and breakfast inn that provides sleeping accommodations of six or fewer rooms, or that provides sleeping accommodations of more than six rooms if the entire inn or those rooms numbering above six are used on an aggregate of two weeks or less per year.
5.2. The food establishments identified in subdivisions 5.1.a., 5.1.b., and 5.1.c. of this section shall provide a sink in the kitchen with at least two compartments. Any mechanical warewashing machine used shall be capable of sanitizing. A separate lavatory located in the kitchen for hand washing is not required.
W. Va. Code R. § 64-17-6 Implementation
6.1. Food establishments in operation at the time this rule becomes effective, and meeting all prior applicable rules, are considered eligible for a permit to operate provided that any construction done after the effective date of this rule is in compliance with this rule.
6.2. New or extensively remodeled food establishments whose plans and specifications received written approval from the commissioner prior to the effective date of this rule are eligible for a permit to operate provided that the construction or remodeling is in compliance with the approved plans.
6.3. Upon implementing this rule, the commissioner shall provide training for local health department personnel.
W. Va. Code R. § 64-17-7 Food Establishment Advisory Board
7.1. The commissioner will maintain an advisory board and will serve as chairman.
7.2. The advisory board members shall include, but are not limited to, representatives of the Bureau for Public Health, local health departments, the retail food industry, restaurants, institutional food service providers, senior programs, convenience stores, and school lunch programs.
7.3. The duties of the board shall include, but are not limited to, developing recommendations on:
7.3.a. Training;
7.3.b. Standardization of local health department personnel and programs;
7.3.c. Interpretations of the provisions of this rule;
7.3.d. Requests for waivers and variances;
7.3.e. Responding to complaints; and
7.3.f. Revisions of the rule.
7.4. The board shall use Annexes 2 through 7 of the Food Code as guidelines in the performance of its duties.
W. Va. Code R. § 64-17-8 Fees
All the fees established in the Bureau for Public Health rules, “Fees for Permits,” 64 CSR 30 and “Fees for Service,” 64 CSR 51, for a food service establishment, mobile food unit, a temporary food establishment, a retail food store, a vending machine, and others are applicable to establishments governed by this rule.
W. Va. Code R. § 64-17-9 Hearings and Administrative Due Process
9.1. A permit applicant, a permit holder, an employee or other person may petition the commissioner in writing, as prescribed in the rule, “Rules of Procedure for Contested Case Hearings and Declaratory Rulings,” 64 CSR 1, for a contested case hearing when the Commissioner has:
9.1.a. Denied his or her application for a permit to operate;
9.1.b. Suspended or revoked his or her permit to operate;
9.1.c. Denied his or her request for a variance;
9.1.d. Issued a hold order;
9.1.e. Issued an employee restriction or exclusion order; or
9.1.f. Otherwise adversely affected the rights, duties, interests or privileges of the petitioner.
9.2. Within 10 days after receipt of the written petition, the commissioner shall grant or deny a hearing on the matter in accordance with the rule, “Rules of Procedure for Contested Case Hearings and Declaratory Rulings,” 64 CSR 1.
9.3. The filing of a petition for a hearing shall not stay or suspend the execution of the notice or order issued by the commissioner.
W. Va. Code R. § 64-17-10 Penalty for Violating Provisions of Rule
Violation of the provisions of this rule is a misdemeanor. The commissioner may take enforcement actions for violation in accordance with W. Va. Code §16-1-18, §16-6-23, and §16-6-24.
64CSR17
64CSR17
Series 18 General Sanitation
W. Va. Code R. § 64-18-1 General
1.1. Scope. B This rule establishes the minimum public health sanitation requirements governing all institutions and schools, care facilities, lodging facilities, recreational facilities, and public restrooms.
1.2. Authority. -- W. Va. Code 16-1-4.
1.3. Filing Date. -- July 12, 2013.
1.4. Effective Date. -- August 12, 2013.
1.5. Applicability. -- This rule applies to every person who in any manner establishes, conducts, controls, manages, maintains, or operates a facility included under the scope of this rule.
1.6. Enforcement. -- This rule is enforced by the commissioner of the bureau for public health.
W. Va. Code R. § 64-18-2 Definitions
2.1. Approved - A procedure of operation, installation or construction which is in accordance with the standards, specifications, and instructions established by the bureau for public health.
2.2. Bed and Breakfast Inn – An establishment providing lodging facilities in the form of sleeping accommodations and, at a minimum, a breakfast for a fee.
2.3. Campground - A tract of land established, maintained, and offered to the public for payment for the location or placement of two or more camping units.
2.4. Camping Unit - Any tent, camping vehicle, cabin, or similar vehicle or structure designed or intended to be used for camping purposes.
2.4.a. A “camping unit” means and includes, but is not limited to, tents, tent campers, fold down campers, pop up campers, travel trailers, camping vans, motor homes, pick up coach campers, or any other unit built or mounted on a vehicle or chassis and capable of being self-propelled or towed.
2.4.b. A “camping unit” shall not include any unit kept by its owner on land occupied by the owner in connection with his or her dwelling, or any unoccupied camping unit kept and stored at a location that has been reserved for storage within a campground.
2.5. Campsite - Any plot of land within a campground used or intended to be used for the location or placement of a camping unit.
2.6. Care Facilities – Include, but are not limited to, public or private halfway houses, adult day care facilities, residential care facilities (such as juvenile group homes and work release centers), and non-disaster shelters (such as homeless shelters and family violence protection shelters). The term does not include health care facilities licensed by the Office of Health Facilities Licensure and Certification in the Office of the Inspector General.
2.7. Commissioner – The commissioner of the bureau for public health or his or her lawful designee.
2.8. Construct - To install, establish, extend, alter or modify.
2.9. Health Officer - The commissioner of the bureau for public health who is also the State Health Officer or the executive officer of the local board of health or his or her lawful representative.
2.10. Hotel - Every building where food and lodging are furnished to guests and payment is required.
2.11. Institution - A public or private facility established by an organization or corporation for the purpose of providing higher education, care, training, rehabilitation or other similar services or functions. An “institution” includes public or private correctional facilities, colleges and universities, and primary and secondary educational facilities (pre-K through grade twelve).
2.12. Labor Camp - A labor camp includes any lumber, mining, agricultural, construction, or other industrial camp where ten or more persons are employed and housed in temporary quarters, such as cars, motor homes, camper vehicles, wagons, tents, cabins, buildings, or other similar enclosures.
2.13. Lodging Facilities – Include, but are not limited to, hotels, motels, labor camps and Bed and Breakfast Inns.
2.14. Mass Gathering - Any group of two hundred fifty (250) or more persons assembled together for a meeting, festival, social gathering, concert or other similar purpose. The term shall not include assembly in any permanent buildings or permanent structures designed, equipped and intended for use by large numbers of people. For the purposes of this subsection, Aequipped@ means supplied with adequate sanitary facilities for the intended use.
2.15. Motel - Every building constructed, designed, maintained, offered or used to furnish lodging to automobile transient guests or the traveling public. The term motel includes auto courts, motor courts, auto lodges, motor lodges, tourist cabins, tourist cottages and tourist courts.
2.16. Nuisance - An annoyance or anything which causes injury, inconvenience, damage, or which essentially interferes with the enjoyment of life or property, and includes, but is not limited to, inadequate or unsanitary sewage, water or plumbing facilities or other unsanitary conditions.
2.17. Occupant - A person utilizing a specific facility governed by this rule.
2.18. Operator - A person who has been granted a written permit, in accordance with this rule, to operate a facility governed by this rule.
2.19. Organized Camp - Any area, place, parcel or tract of land on which facilities are established or maintained to provide an outdoor group living experience for children or adults, or where one or more permanent or semi-permanent structures are established or maintained as living or sleeping quarters for children or adults, and operated for educational, social, recreational, religious instruction or activity, physical education or health, or vacation purposes either gratuitously or for compensation. This definition shall not be construed to include a hunting, fishing, or other camp privately owned and used exclusively for the personal pleasure of the owner.
2.20. Permit - A written document issued by the health officer giving a person permission to operate a specific facility governed by this rule.
2.21. Person - An individual, partnership, association, syndicate, company, firm, trust, corporation, institution, department, division, bureau, agency, or any entity recognized by law.
2.22. Primitive Camping – Campsites provide for temporary use by persons seeking a very basic outdoor experience, without amenities typically found in a campground. Camping sites for primitive camping are not provided with water under pressure or electrical service.
2.23. Public Restroom - A structure housing toilet, lavatory, or other such facilities intended for the unrestricted use by the public.
2.24. Recreational Facilities – Include, but are not limited to, campgrounds, parks, playgrounds, organized camps, fairs, festivals and mass gatherings.
2.25. School - A public or private organization that provides instruction for the teaching of children. The term includes early childhood / primary education centers, middle childhood / junior high education centers, adolescent / high school education centers and vocational education centers. The term does not include child care centers as defined in the bureau for public health rule, Child Care Centers, 64CSR21. Schools include public or private correctional facilities, colleges and universities and primary and secondary educational facilities (pre-K through grade twelve).
2.26. Service Animal - Any guide dog, signal dog, or other animal individually trained to provide assistance to an individual with a disability.
2.27. Sewer Connection - The connection consisting of all pipes, fittings, and appurtenances from the waste drain outlet of a facility to the inlet pipe of the corresponding sewer riser pipe of the sewer system serving a specific facility governed by this rule.
2.28. Sewer System - A system whether publicly or privately owned which receives and treats sewage and provides for the disposal of effluent and sludge from the system. Included in this definition are individual sewer systems and public sewer systems.
2.29. Waste Disposal Station - A facility used for disposing of excreta or sewage from a camping unit waste holding tank.
2.30. Wastewater - Water containing human, animal, or domestic waste.
2.31. Water Connection - The connection consisting of all pipes, fittings and appurtenances from the water connection inlet of a facility to the outlet pipe of the corresponding water riser pipe of the water distribution system serving a specific facility governed by this rule.
2.32. Water Supply System - A system of pipes, appurtenances and equipment for the collection, treatment, storage or distribution of water.
W. Va. Code R. § 64-18-3 Plan Review, Permits, Hearings, Notices and Orders
3.1. Plan Review
3.1.a. Except as provided in paragraph 3.1.a.1 of this section, whenever a facility governed under the scope of this rule is constructed or extensively remodeled and whenever an existing structure is converted to use as one of the facilities governed under this rule, the owner or operator shall submit plans and specifications for the construction, remodeling, or conversion to the health officer for review and approval at least forty-five (45) days before construction, remodeling, or conversion is begun.
3.1.a.1. This section does not apply to colleges and universities or to public restrooms unless the public restroom is included as part of a facility governed under this rule.
3.1.a.2. Once completed plans are received by the health officer, the health officer shall review the plans within a period of time not to exceed forty-five (45) days.
3.2. Permit to Operate
3.2.a. Except as provided in paragraph 3.2.a.1 of this subdivision, no person shall operate a facility governed by this rule who does not possess a valid permit issued to him or her by the health officer.
3.2.a.1. This provision shall not apply to colleges and universities or to the operation of a public restroom unless it is included as part of a facility governed under this rule.
3.2.b. The applicant shall submit a written application for a permit to operate a facility governed by this rule to the health officer on a form prescribed by the health officer and signed by the applicant or his or her authorized representative.
3.2.c. The applicant shall submit to the health officer an application for a permit at least fifteen (15) days before the actual or proposed operation of the facility is to be effected.
3.2.d. Prior to approving the application for a permit, the health officer shall inspect the proposed facility to determine compliance with this rule. Only persons who comply with the applicable provisions of this rule are entitled to a permit.
3.2.e. Facilities governed by this rule, in operation at the time this rule becomes effective, and meeting all applicable prior rules are eligible for a permit to operate, provided that the facility shall meet the applicable operational requirements of this rule, and, provided further, that any construction taking place after the effective date of this rule shall be in compliance with this rule and other applicable design standards and rules.
3.2.f. Permits are not transferable or assignable and automatically become invalid upon a change of ownership of the facility or upon suspension or revocation of the permit.
3.2.g. A permit to operate expires at midnight on the 30th day of June following the date of issuance.
3.2.h. The applicant shall submit to the health officer an application for the renewal of a permit at least fifteen (15) days prior to the expiration date of the existing permit.
3.2.i. In the event of an intended change or an actual change in ownership of a facility, an applicant shall submit an application for a permit to operate to the health officer at least 15 days before the proposed or actual change is affected.
3.2.j. The health officer may suspend or revoke a permit if he or she finds that the facility is being maintained or operated in violation of this rule.
3.2.k. The health officer may revoke a permit to operate for repeated or serious violations of any of the requirements of this rule or for interference with the health officer in the performance of his or her duties.
3.2.l. The health officer shall not reinstate a permit to operate until he or she determines by an inspection that the facility is in compliance with all applicable provisions of this rule and any orders, rules or instructions issued by the health officer.
3.2.m. The operator shall post the operational permit in a conspicuous place within the facility, and the permit shall be readily available to the health officer.
3.3. Hearings, Notices and Orders.
3.3.a. Whenever the health officer makes an inspection of a facility and discovers that any of the provisions of this rule have been violated, he or she shall notify the operator of the violations by means of an inspection report form or other written notice. The operator shall correct the violations within the time specified in the notice.
3.3.b. Whenever the health officer finds that any facility governed by this rule constitutes an imminent hazard to public health, he or she may, without notice or hearing, issue a written order to the operator or person in charge citing the existence of the condition and requiring action to be taken to remedy the condition, including the suspension of the permit to operate. Notwithstanding any other provision of this rule, the order is effective immediately.
3.3.b.1. Any person to whom the order is directed shall comply with the order immediately, but upon written petition to the health officer shall be afforded a hearing on the matter as set forth in subdivision 3.3.c. of this rule.
3.3.c. Any person whose application for a permit to operate a facility governed by this rule has been denied, or whose permit has been suspended or revoked, may submit a written petition to the health officer requesting a hearing on the matter. The health officer shall grant a hearing on the matter within ten (10) days after he or she has received the written petition.
3.3.d. The filing of a petition for a hearing on a permit denial, suspension, or revocation shall not stay or suspend the execution of the notice or order resulting in the permit denial, suspension, or revocation.
W. Va. Code R. § 64-18-4 Inspections
4.1. Except as specified in subdivisions 4.1.a and 4.1.b of this section, the health officer shall inspect a facility governed by this rule at least once a year.
4.1.a. Colleges and universities and public restrooms which are not part of a facility governed by this rule may be inspected on a complaint basis only.
4.1.b. Schools shall be inspected at least once every two years.
4.2. The health officer shall make additional inspections as necessary to determine satisfactory compliance with the provisions of this rule or any orders, notices, instructions or specifications issued pursuant to this rule.
4.3. The health officer shall discuss the inspection report with the person in charge at the time of inspection.
W. Va. Code R. § 64-18-5 Animals
5.1. A facility falling within the scope of this rule may keep or house domestic animals or pets under conditions conducive to proper sanitation and good health.
5.2. No live reptiles shall be kept or housed unless a written plan is provided and implemented for proper sanitary handling and hand washing.
5.3. No wild, dangerous or obviously ill animals are to be kept or fed in an area that would endanger inhabitants or patrons of the facility.
5.4. No dogs, cats or other domestic animals shall be permitted to run at large.
5.5. If the facility has dogs or cats, they must be immunized by a licensed veterinarian for any disease which can be transmitted to humans and for which there is a vaccine.
5.6. Animal quarters shall be kept in a clean condition at all times and located and maintained so as not to create a nuisance.
5.7. All manure shall be removed and sanitarily disposed of at a frequency necessary to minimize objectionable odors or insect and rodent breeding.
5.8. Drainage from stables, pens, coops or other animal quarters shall be disposed of in a manner to prevent contamination of any source of potable water, groundwater, or surface water.
5.9. The maximum number of animals in any facility shall be limited to the number that can be adequately housed, fed, and maintained.
5.10. Live animals, including birds and turtles, shall be excluded from food preparation, storage, and serving areas and in in-use dining areas. This exclusion does not apply to edible fish, crustacea, shellfish, or to fish in aquariums.
5.10.a. Service animals may be permitted in dining areas.
W. Va. Code R. § 64-18-6 Bedding and Sleeping Areas
6.1. All rooms or areas used for bedding and sleeping shall be kept clean and sanitary, maintained in a safe condition and in good repair.
6.2. Floors in sleeping quarters shall be easily cleanable, in good repair and located to prevent ground and surface water entry.
6.3. Tents used as permanent sleeping quarters shall be placed on platforms or floors elevated at least one foot above the ground surface. Concrete pads may be used in lieu of platforms on floors.
6.4. Single occupancy sleeping areas shall contain a minimum of seventy (70) square feet of floor space per person.
6.5. In multiple occupancy rooms or areas used for a combination of eating, sleeping or cooking, a minimum of fifty (50) square feet of floor space is required per occupant.
6.5.a. Any state prison, correctional facility, work release center or other facility for the housing of criminal offenders or detainees governed by this section, upon any inspection required by this rule, the facility may request an exemption from this subsection regarding square footage if the following conditions are met:
6.5.a.1. There is a conflict between the minimum square footage requirements of this subsection and the minimum square footage requirements established by the current applicable standards of the American Correctional Association (the “Standards”); and
6.5.a.2. The facility desiring the exemption provides the bureau for public health with a copy of the ACA Standards at the same time that it submits a written request for an exemption.
6.5.b. Upon satisfaction of the provisions of 6.5.a, of this subsection, the bureau may grant the request for exemption, in which case the square footage requirements of the American Correctional Association Standards shall govern. In all other respects, the requirements of this rule apply to these facilities or institutions.
6.6. Except for tents, no sleeping area shall have a ceiling height of less than seven (7) feet measured from the floor.
6.7. Sleeping areas shall be designed to provide a minimum of three feet between beds, both laterally and end to end. Beds shall be placed so that the heads of sleepers are at least six feet apart. These spacing requirements for beds do not apply to hotels, motels, or bed and breakfast inns.
6.8. When double-decker beds are used, there shall not be less than twenty-seven (27) inches between the lower mattress and the bottom of the upper bed and not less than twenty-seven (27) inches between the ceiling and the top mattress of the upper bed.
6.9. Triple decker beds are prohibited.
6.10. A bed and bedding shall be provided for each person.
6.11. Mats or cots used for short term napping shall be spaced two feet apart on all sides.
6.12. All articles of bedding and furniture shall be kept clean and in good repair.
6.13. All fabric mattresses shall be provided with mattress pads or mattress covers.
6.14. Linens shall be provided except in those facilities where the user is normally required to bring his or her own linens.
6.15. Linen, if provided, shall be changed at least once weekly or more often if needed, and clean linen provided.
6.16. A clean set of linen shall be provided for each succeeding occupant.
6.17. Storage area or areas shall be provided for the storage of excess clothing, luggage, or similar articles.
6.18. Sleeping areas in primitive or outpost camping or similar recreational activities are exempt from the requirements of this section.
W. Va. Code R. § 64-18-7 Communicable Disease
7.1. Good hygienic practices and disease control measures shall be employed to prevent the spread of communicable disease.
7.2. No staff member while affected with any disease in a communicable form, or while a carrier of a communicable disease, or while affected with boils, infected wounds, sores, or a respiratory infection shall work in any capacity in which there is likelihood of the staff member transmitting disease to other persons.
7.3. All staff members in care facilities, correctional facilities, schools, and similar facilities where a close staff/client relationship exists shall:
7.3.a. Wear clean outer garments and maintain a high degree of personal cleanliness;
7.3.b. Conform to good hygienic practices while on duty;
7.3.c. Thoroughly wash hands and the exposed portions of arms with soap and warm water before starting work, during work as often as necessary to keep them clean, and after smoking, eating, drinking or using the toilet; and
7.3.d. Not use tobacco in any form while performing duties. If not prohibited by law, the health officer may designate specific areas for tobacco use when the staff member is not engaged in the performance of his or her duties.
7.4. The operator shall maintain a register containing a record of all occupants.
7.4.a. The register shall be available to the health officer and shall be preserved for a minimum of twelve (12) months.
7.4.b. The register shall contain the name and address of the occupants and the dates of occupancy.
7.4.c. A register need not be maintained for mass gatherings, parks, playgrounds, and public restrooms.
W. Va. Code R. § 64-18-8 Garbage and Refuse
8.1. Storage, handling, collection, transportation and disposal of garbage and refuse shall be conducted to prevent odor, insect, rodent and other nuisance conditions.
8.2. All garbage and refuse shall be stored in approved water tight, vermin proof, and easily cleanable containers. There shall be a sufficient number of containers to hold all the garbage and refuse that accumulates.
8.3. Garbage and refuse containers shall be kept clean.
8.4. When not in continuous use, garbage and refuse containers shall be covered at all times except those containers used only for non-putrescible and non-infectious wastes.
8.5. Excluding mass gatherings, garbage and refuse containers, enclosures, dumpsters and compactor systems located outside shall be stored elevated or on metal racks or on a smooth surface of non-absorbent material such as concrete or asphalt that is kept clean and maintained in good repair.
8.6. Outside storage areas or enclosures shall be large enough to store the garbage and refuse containers that accumulate and shall be kept clean.
8.7. Garbage and refuse storage rooms and outside enclosures, if used, shall be constructed of easily cleanable, non-absorbent, washable materials, shall be kept clean, shall be insect and rodent proof, and shall be large enough to store the garbage and refuse containers that accumulate.
8.8. Garbage and refuse containers shall be readily accessible for use and servicing.
8.9. If garbage and refuse container cleaning operations are conducted outside, then a frost proof hose bib and sanitary waste drain shall be provided.
8.10. Disposal of garbage and refuse shall be in compliance with the applicable laws.
W. Va. Code R. § 64-18-9 Heating and Ventilation
9.1. Every indoor space intended for human occupancy shall be ventilated by natural or mechanical means. The minimum amount of outdoor air shall be five (5) cubic feet per minute per person.
9.2. All rooms shall have sufficient ventilation to keep them free of excessive heat, steam, condensation, vapors, obnoxious odors, smoke and fumes.
9.3. Ventilation systems, when vented to the outside, shall not create a nuisance or public health hazard.
9.4. Heating, ventilation and air-conditioning systems shall be in compliance with the requirements of the State Building Code.
9.5. Intake and exhaust air ducts shall be located and maintained to prevent the entrance of dust, dirt, and other contaminating materials.
9.6. For mechanical ventilation, indoor design temperature shall be sixty-eight (68) degrees Fahrenheit for heating and seventy-eight (78) degrees Fahrenheit for cooling.
9.7. If operated during the normal heating season, the facility shall be equipped with approved heating units sufficient to provide and maintain a temperature of sixty-eight (68) degrees Fahrenheit or greater in routinely occupied indoor areas unless the facility is intended or designed for low temperature operation.
9.8. Oil and gas fired heating devices shall be properly vented to the outside air or otherwise in compliance with the State Building Code.
9.9. Clothes dryer vent systems shall be independent of all other systems and shall convey the products of combustion and moisture to the outside.
W. Va. Code R. § 64-18-10 Housekeeping and Maintenance
10.1. The entire premises and its contents shall be maintained in good repair and in a clean and sanitary condition. Facilities and equipment shall be provided for this purpose.
10.2. Cleaning and sanitizing shall be conducted at a frequency necessary to maintain an environment conducive to the general safety, health and comfort of the users.
10.3. A written plan providing for a regular schedule of housekeeping tasks shall be provided and implemented for institutions, schools, care facilities, lodging facilities and organized camps.
W. Va. Code R. § 64-18-11 Laundry
11.1. Laundry, if done on the premises, shall be done in a separate area, room, or rooms designed for that particular purpose.
11.2. Soiled laundry shall be stored in non-absorbent, easily cleanable, covered containers or covered laundry bags intended for laundry storage.
11.3. Clean laundry shall be stored in such a manner so as not to become soiled or contaminated.
11.4. Soiled and clean laundry shall be handled, stored, processed and transported in such a manner as to prevent the spread of infection.
11.5. Laundry rooms and equipment shall be maintained in a clean and sanitary condition.
11.6. Chemicals and materials used in laundry operations shall be labeled, stored, handled, and used so as to provide maximum cleaning and disinfecting efficiency and prevent injury to the user.
11.7. All laundered articles shall be washed at a temperature which gives the best performance in relation to the types of soil, level of soil, fabric types and chemicals used. Manufacturers= instructions regarding time, temperature, mechanical agitation and chemical action should be followed in the washing process.
11.8. All laundered articles shall be rinsed to remove the cleaning agent.
11.9. After washing and rinsing, laundered articles must be either rinsed in a chemical sanitizing solution and air dried, or mechanically dried.
11.10. An individual laundering his or her own personal belongings is exempt from the requirements of subsections 11.7, 11.8, and 11.9 of this section provided that the handling, storage, processing and transporting of the individual's laundry does not contaminate surrounding areas or other laundry.
11.11. Laundry facilities shall be made available on a regular basis to occupants of labor camps.
W. Va. Code R. § 64-18-12 Lighting
12.1. Lighting levels shall be commensurate with the type of activity occurring within the area.
12.2. Light sources shall be installed or available to provide the following minimum foot candles of light:
12.2.a. Twenty (20) foot candles of light shall be provided in critical cleaning areas, including, but not limited to, food preparation areas, utensil washing areas, toilet and bathing facilities, and laundry areas. Dining areas shall not be considered critical cleaning areas;
12.2.b. Ten (10) foot candles of light shall be provided in normal cleaning areas, including, but not limited to, corridors, lobbies, janitor=s closets, storage areas, and lodging quarters;
12.2.c. One hundred (100) foot candles of light shall be provided in hazardous work areas, including, but not limited to, workshops and school laboratories; and
12.2.d. Forty (40) foot candles of light shall be provided in reading and activity areas, including, but not limited to, classrooms, day rooms, play rooms, and meeting rooms.
12.3. Lighting may be by either natural or artificial means or both.
12.4. All light bulbs and fluorescent tubes shall be protected by effective shields or the use of shatterproof bulbs over food preparation areas, showers, gymnasiums, and any other area where safety is a concern. These areas include the classrooms in primary and secondary schools.
12.5. Tamper proof light fixtures shall be provided in areas where a safety hazard may exist to the user or where abuse is likely.
12.6. Primitive camping areas are exempt from the requirements of this section.
W. Va. Code R. § 64-18-13 Noise
13.1. All facilities falling under the scope of this rule and constructed after the effective date of this rule shall incorporate reasonable acoustic planning into the facility design and site selection.
13.2. Acoustic planning for the construction of a facility shall take into consideration the effects of exposure to noise on the physical health, mental health, and comfort of the facility user within the context of the intended use of the facility.
13.3. The commissioner may develop, through interpretive rule, ranges of design goals for ambient sound levels in facilities covered under this rule and require estimated ambient sound levels in decibels to be shown in plans submitted for review.
W. Va. Code R. § 64-18-14 Plumbing
14.1. In the absence of applicable bureau for public health rules and design standards, water supply and wastewater systems and fixtures shall comply with the requirements of the State Building Code.
14.2. Any plumbing or drainage system under the jurisdiction of this rule shall be maintained in good repair and in a sanitary and serviceable condition by the owner or his agent.
14.3. Plumbing fixtures shall be installed in a manner to afford easy access for cleaning and shall not be located in such a manner as to interfere with the use or the normal operation of doors, windows or other exit openings.
14.3.a. Exposed utility service lines and pipes shall be installed in a way that does not obstruct or prevent cleaning of the floors, walls and ceilings.
14.3.b. Utility service lines and pipes shall not be unnecessarily exposed on floors, walls or ceilings.
14.4. Drainage system vent terminals shall extend to the outer air and be installed to minimize the possibilities of clogging and the return of foul air into the building or into adjoining structures.
14.5. Plumbing fixtures directly connected to a drainage system shall be equipped with a water-seal trap.
14.6. Plumbing fixtures shall have a smooth impervious surface and be constructed of materials especially suited to the use for which the fixture is intended.
14.7. A service or utility sink is required in all establishments where wet cleaning methods are used.
14.8. Plumbing fixtures shall be of appropriate design so that when installed and maintained back-siphonage, backflow, and cross connection potentials are eliminated.
W. Va. Code R. § 64-18-15 Safety
15.1. All premises and facilities available to public patronage, employment, confinement, or use shall be designed, maintained and operated to minimize safety hazards and promote an accident-free environment.
15.2. Adequate protection against all electrical hazards shall be provided.
15.3. The design, installation and maintenance of the facility shall comply with applicable State Fire Marshal's rules.
15.4. The design, maintenance and arrangement of facilities, including lighting, shall minimize hazards of falls, slipping and tripping.
15.5. A fence or barrier shall be provided around any outdoor playground or activity area located in an area where safety may be a concern and which is used by children or persons not capable of self-preservation.
15.6. Except for parks, playgrounds, and public restrooms, a first aid kit shall be provided.
W. Va. Code R. § 64-18-16 Sewage
16.1. Sewage and liquid waste disposal systems shall comply in full with the bureau for public health rule, Sewer Systems, Sewage Treatment Systems, and Sewage Tank Cleaners, 64CSR9.
16.2. Sewage and liquid waste disposal systems shall be kept in good repair and properly maintained and operated.
16.3. Liquid waste shall not be deposited on the ground in a manner that may create a nuisance.
16.4. Adequate access for approved cleaning vehicles and operations shall be provided to all self-contained privies and portable excreta disposal units.
W. Va. Code R. § 64-18-17 Size, Space
17.1. In campgrounds, one thousand two hundred (1200) square feet of space shall be provided for each campsite. The average campground density shall not exceed twenty-five (25) campsites per acre.
17.2. In campgrounds, camping units, including canopies and similar appurtenances, shall be separated from other camping units on adjacent campsites and all campground buildings and structures by a minimum distance of ten (10) feet.
17.3. There shall be at least ten (10) feet of space between a camping unit and any campground street, common parking area, or other common use areas and at least twenty (20) feet between a camping unit and a public road.
17.4. Campground areas used exclusively for backpack type of camping are exempted from subsections 17.2 and 17.3 of this section provided the use of these areas will not adversely affect public health.
17.5. For mass gatherings, at least twenty (20) square feet per person shall be provided at the site for day time assemblage, and at least forty (40) square feet per person shall be provided for overnight assemblage, exclusive of parking areas.
17.6. For mass gatherings, adequate parking space shall be provided for every four (4) persons with the density not to exceed one hundred (100) passenger cars or thirty (30) buses per usable acre.
17.7. School classrooms shall provide a minimum of twenty-eight (28) square feet of space per student.
17.8. Bedding and sleeping areas shall be sized according to section 6 of this rule.
W. Va. Code R. § 64-18-18 Storage
18.1. Appropriate storage facilities of cleanable construction shall be provided for, but not limited to, the following items: food; utensils; toys; work materials; cleaning supplies; clothing; linens; medicines; and toxic materials.
18.2. All storage facilities shall be maintained in a neat, orderly, and clean condition.
18.3. Only those articles necessary for the operation and maintenance of the facility shall be stored on the premises.
18.4. All items intended for human consumption or human contact shall be protected from contamination during storage.
18.5. Poisons and other potentially hazardous items shall be properly labeled and stored in locked storage spaces not used for any other purpose. Keys for the storage spaces shall be available only to authorized staff members.
W. Va. Code R. § 64-18-19 Structure, Materials, Construction and Repair
19.1. Every foundation, roof and exterior wall, door, skylight and window shall be reasonably weather-tight, watertight, and damp-free, and shall be kept in sound condition and good repair.
19.2. Floors, interior walls and ceilings shall be sound and in good repair.
19.3. Materials, adhesives and coverings used in interior areas shall be limited to a type that minimizes offensive or hazardous emissions to individuals who use or occupy the facility.
19.4. All exterior wood surfaces, other than decay resistant woods, shall be protected from the elements and decay by paint or other protective covering or treatment using nontoxic materials where accessible to children.
19.5. The interior finish of floors, walls, and ceilings shall be constructed of materials which are suitable for the intended use of the area and the frequency and type of cleaning methods necessary to maintain these finishes in a sanitary condition.
19.6. Floors, walls and ceilings in toilet rooms, food preparation areas, bathing facilities, and similar areas shall be easily cleanable, non-absorbent, and capable of withstanding routine wet cleaning methods. Other types of floor coverings may be permitted in areas where necessary for safety reasons, provided they do not interfere with floor cleaning.
19.7. Accessory structures present or provided shall be structurally sound and be maintained in good repair or they shall be removed from the premises.
19.7.a. The exterior of accessory structures shall be made weather-resistant through the use of decay-resistant materials or the use of paint or other preservatives.
19.8. Every foundation, roof, floor, exterior and interior wall, ceiling, inside and outside stair, every porch, and every appurtenance thereto, shall be safe to use and capable of supporting the loads that normal use may cause to be placed on them.
W. Va. Code R. § 64-18-20 Surroundings
All parts of property used in connection with the operation of the facility shall be kept neat, clean, adequately drained, free of litter and vermin harborage, and designed, located, maintained and operated so as not to endanger the public health or to create a nuisance or safety hazard.
W. Va. Code R. § 64-18-21 Toilet, Hand Washing and Bathing Facilities
21.1. Toilet, hand washing, and bathing facilities shall be provided in the number required in the State Building Code.
21.1.a. Labor camps and organized camps shall provide one water closet and one lavatory for each ten (10) occupants and one (1) bathtub or shower for each eight (8) occupants, or fraction thereof.
21.1.b. Parks and playgrounds shall provide at least one (1) water closet and one lavatory for each sex.
21.1.c. Campground comfort stations, if provided, shall provide for each twenty (20) campsites or fraction thereof one (1) water closet for males, two (2) water closets for females, one (1) lavatory for each sex, and one (1) bathtub or shower for each sex.
21.1.d. In mass gatherings, a ratio of one (1) water closet for each one hundred (100) persons shall be provided for the first one thousand (1000) persons, then an additional two (2) water closets per one thousand (1000) thereafter. When water under pressure is provided, one (1) lavatory for every two (2) water closets shall be provided.
21.1.e. Urinals may be substituted for up to fifty percent (50%) of the required number of water closets.
21.2. Toilet, hand washing and bathing facilities shall be designed, constructed, installed, maintained, and operated in a sanitary manner.
21.3. Rooms containing toilet facilities shall be vented to the outside air. Adequate ventilation or humidity control shall be provided as needed in shower rooms and other high humidity areas.
21.4. An adequate supply of toilet tissue shall be provided at each water closet.
21.5. All hand washing facilities shall be provided with hand cleansing soap or detergent, and sanitary towels or a hand drying device providing heated air, adjacent to each hand washing sink.
21.5.a. If disposable towels are used, easily cleanable waste receptacles shall be conveniently located near the hand washing facilities.
21.6. If bathing facilities are provided, occupants shall be provided with soap and clean washcloths and towels.
21.6.a. Occupants shall be provided with clean washcloths and towels at least once weekly or more often if needed.
21.6.b. Washcloths and towels shall be freshly laundered before being furnished to occupants.
21.7. Common use towels are prohibited.
21.8. The supplies required under subsection 21.6 of this rule are not required to be provided in those facilities where the user is normally required to bring his or her own soap, washcloths and towels.
21.9. Hand washing facilities, where provided, shall be in or immediately adjacent to the toilet facilities.
21.10. Toilet, hand washing, and bathing facilities shall meet the requirements of section 23 of this rule.
21.11. Any self-closing or metering faucet shall be designed to provide a flow of water for a minimum of fifteen seconds without the need to reactivate the faucet.
21.12. Except for privies, unless properly constructed privacy barriers are provided, toilet rooms shall be completely enclosed and shall have tight-fitting doors which shall be closed except during cleaning or maintenance.
21.13. Privies shall meet the requirements of section 16 of this rule.
21.14. Toilet rooms used by women shall have at least one covered waste receptacle for the disposal of sanitary napkins or other similar products.
21.15. In facilities which are mainly used by children, toilet and hand washing fixtures shall be sized so that they may be used by children without assistance, or step stools that are properly constructed for safety and ease of cleaning shall be provided.
21.16. In institutions, schools, and care facilities, a diaper changing area shall be established and used by staff members when they change the diapers and soiled underwear of individuals under their care. The changing area shall not be located in food preparation areas.
21.16.a. Hand washing facilities shall be readily accessible to the diaper changing area.
21.16.b. Diaper changing shall be done on a clean, safe, impervious, nonabsorbent surface which is used for no other purpose.
21.16.c. The individual=s perineal (urinary and anal) area shall be cleaned with disposable wipes.
21.16.d. After a staff member removes an individual=s soiled diaper or soiled underwear, and before the staff member puts a fresh diaper on the individual, the staff member shall wipe his or her own hands with a pre-moistened towelette or a damp paper towel.
21.16.e. Both the individual=s and the staff member=s hands shall be thoroughly washed after each diaper change. If disposable gloves are used, they shall be discarded immediately and hands washed.
21.16.f. Changing tables and surfaces shall be cleaned and disinfected after each use by cleaning to remove visible soil, followed by wiping with an approved disinfectant solution, whether or not disposable, nonabsorbent paper is used. If disposable paper is used, it shall be discarded immediately after each diapering.
21.16.g. Soiled cloth diapers and underwear shall be stored in nonabsorbent, easily cleanable, covered containers with plastic liners. The containers shall be emptied, cleaned and disinfected daily.
21.16.h. Soiled disposable diapers will be stored in conveniently located, washable, plastic lined, tightly covered waste containers. Each container shall be labeled and kept clean and free of buildup of soil and odor.
21.16.i. Toilet-training chairs, if used, shall be of easily cleanable construction, and after each use, shall be emptied into a toilet, and thoroughly cleaned and sanitized in a utility sink.
21.16.j. Hand washing sinks shall not be used for rinsing soiled diapers or clothing, or for cleaning toilet-training equipment.
W. Va. Code R. § 64-18-22 Vector Control
22.1. Effective measures shall be used to minimize the presence of rodents, flies, cockroaches, and other insects and vermin on the premises.
22.2. The premises shall be kept in such condition as to prevent the harborage or feeding of insects, rodents, and other vermin.
22.3. Applicable doors, windows and other exterior openings shall be effectively protected against the entrance of rodents, insects, and other vermin. These areas include, but are not limited to, food service areas, toilet facilities, and housing areas. This requirement does not apply to primitive camping, outpost camping or similar recreational activities.
22.4. Screening material shall not be less than sixteen (16) mesh to the inch.
22.5. Only those pesticides approved by the United States Environmental Protection Agency and the United States Department of Agriculture shall be used.
22.6. Poisonous or toxic materials shall not be used, stored or disposed of in a way that constitutes a hazard to employees or other persons, nor in a way other than in compliance with the manufacturer's specifications.
W. Va. Code R. § 64-18-23 Water Supply
23.1. An approved, adequate, easily accessible, potable water supply shall be provided. This provision may be waived by the health officer for campgrounds, campsites, mass gatherings, and similar areas where compliance is impractical.
23.2. Water supplies shall be installed, constructed, maintained, operated and monitored in compliance with bureau for public health rules, Public Water Systems, 64CSR3; Water Well Regulations, 64CSR19 and Cross-Connection Control and Backflow Prevention, 64CSR15.
23.3. Hot and cold running water shall be supplied through a mixing valve or combination faucet in all areas where food is prepared, at all hand washing and bathing facilities, and all other applicable areas. This provision may be waived by the health officer for campgrounds, campsites, mass gatherings, and similar areas where compliance is impractical.
23.3.a. Hot water means water heated to a temperature of not less than 110 degrees Fahrenheit.
23.3.b. Steam-mixing valves are prohibited.
23.3.c. Water temperatures for showers, bathing, or hand washing shall be thermostatically controlled to insure the safety of users.
23.4. Drinking fountains, if provided: shall be constructed of impervious material; shall have an angle-jet nozzle protected by a non-oxidizing mouth guard above the overflow rim of the bowl; shall be equipped with a pressure regulating valve; and shall be maintained in a sanitary manner.
23.4.a. Drinking fountain/lavatory combinations where the water fountain is part of the cold water faucet or is built into the sink=s basin are prohibited.
23.4.b. Drinking fountains, if provided, shall be at the ratio required in the State Building Code.
23.5. No dipping vessels or cups for common use are permitted.
23.6. Drinking cups shall be dispensed from an approved sanitary single service dispenser. This requirement does not preclude the use of properly washed and sanitized glasses.
23.7. Where portable drinking water containers or coolers are used, they shall be of easily cleanable construction, securely closed, and constructed and arranged so that water can only be withdrawn from the container by a water tap or faucet.
23.7.a. Pitchers, water jugs, or similar receptacles without water taps or faucets may be used if they are easily cleanable, of approved construction, and in good repair, and the water contained in them is protected against contamination.
23.7.b. All portable water containers shall be kept clean, sanitized between uses, and properly stored and handled.
23.8. All ice intended for human consumption or for food storage shall be obtained from a source approved by the health officer and shall be made, stored, transported, and handled under sanitary conditions.
23.8.a. Ice intended for self-service shall be dispensed from automatic self-service ice dispensing equipment.
23.9. The commissioner may permit the use of potable water transported in tanks to supplement the existing water supply or as the sole source of water supply.
23.9.a. Transported water shall be from an approved public water supply and maintained with at least one (1.0) mg per liter free chlorine residual or an equivalent strength of another disinfectant as approved by the health officer.
23.9.b. Equipment and procedures used to transport and dispense potable water shall be approved by the health officer.
W. Va. Code R. § 64-18-24 Penalty for Violating Provisions of Regulations
Any person violating any of the provisions of this rule, or orders issued pursuant to this rule, is punishable by a fine of not more than two hundred dollars ($200) or by imprisonment for not more than thirty (30) days, or both. Each day=s failure to comply with any applicable provision of this rule constitutes a separate offense.
W. Va. Code R. § 64-18-25 Administrative Due Process
Those persons adversely affected by the enforcement of this rule desiring a contested case hearing to determine any rights, duties, interests or privileges shall do so in a manner prescribed in the bureau for public health's rule, Rules of Procedure for Contested Case Hearings and Declaratory Rulings, 64CSR1.
64CSR18
Series 19 Water Well Regulations
W. Va. Code R. § 64-19-1 General
1.1. Scope. -- This legislative rule establishes the certification requirements for water well drillers; pump installers, and the issuance of permits for water wells. The purpose is to protect the public health, protect and prevent contamination in groundwater, and ensure fair and equitable rules for the construction of water wells and installing pumps and pumping equipment in the State of West Virginia.
1.2. Authority. -- W. Va. Code §§16-1-4, 16-1-6(n), 16-1-9, and 16-1-9a.
1.3. Filing Date. -- April 13, 2026.
1.4. Effective Date. -- July 1, 2026.
1.5. Sunset Provision. -- This rule shall terminate and have no further force or effect on August 1, 2028.
W. Va. Code R. § 64-19-2 Application and Enforcement
2.1. Application. -- This rule applies to all water well drillers and pump installers where the pump is situated in a water well or pulls water from a well.
2.2. Enforcement. -- This rule shall be enforced by the Commissioner.
W. Va. Code R. § 64-19-3 Definitions
3.1. Application. -- The Bureau’s standard forms for applying for well driller and pump installer certification, water well permit, or permit modification, including any additions, revisions, or modifications to the form.
3.2. Apprentice. -- A person working under the direction of a master or journeyman well driller or a pump installer.
3.3. Bureau. -- The Bureau for Public Health in the West Virginia Department of Health.
3.4. Casing. -- Pipe or tubing, constructed of specific materials with specified dimensions and weights, that is installed in a borehole during or after completion of the borehole to support the side of the hole and thereby prevent caving, to allow completion of the well, to prevent formation material from entering the well, and to prevent entry of undesirable water into the well.
3.5. Certified Well Driller. -- An individual granted a written certificate by the Commissioner to drill, construct, alter, or abandon water wells who meets the requirements of this rule.
3.6. Commercial Well -- A well that serves small businesses and facilities in which water is the prime ingredient of the service rendered.
3.7. Commissioner. -- The Commissioner of the West Virginia Bureau for Public Health or his or her designee.
3.8. Continuing Education Hour. -- One hour of participation in an organized continuing education experience under the direction of a sponsor approved by the Commissioner for renewal of a certification. One Continuing Education Hour is equal to one point.
3.9. Design Standards. -- Those specifications, drawings, and other details promulgated by the Commissioner to ensure proper location, design, construction, completion and abandonment of water wells and installation or removal of water pumps as referenced in the Bureau’s rules, Water Well Design Standards, 64CSR46, and Public Water System Design Standards, 64CSR77.
3.10. Dewatering Well. -- A well used to lower groundwater levels to allow for construction of footings, sewer lines, building foundations, dams, etc.
3.11. Hand Dug Well. -- A manually excavated well of a permanent nature installed for water supply.
3.12. Heat Pump or Geothermal Well. -- Any well constructed to use the heat exchange properties of either groundwater or of geologic material penetrated by the well.
3.13. Inactive Well. -- A well that is no longer actively used. It shall have a sanitary well cap and remain in a state of repair to prevent contamination from entering the well. It may be used in the future or be properly abandoned.
3.14. Industrial Well. -- A well used in industrial processing, fire protection, washing, packing, or manufacturing of a product excluding food and beverages, or similar non-potable uses.
3.15. Irrigation Well. -- A well used to provide water for plants, livestock, or other agricultural processes.
3.16. Journeyman Well Driller. -- A person certified by the Commissioner to practice well drilling under the general supervision of a master well driller.
3.17. Master Well Driller. -- A person certified by the Commissioner to practice well drilling including pump and pumping equipment installation, and removal, when maintenance or repair of a well is required.
3.18. Person. -- An individual, partnership, association, syndicate, company, firm, trust, corporation, government corporation, institution, department, division, bureau, agency, federal agency, or any other entity recognized by law.
3.19. Potable Water. -- Water free from impurities in amounts sufficient to cause disease or harmful physiological effects, with bacteriological, chemical, physical, and radiological quality conforming to applicable rules and standards of the Bureau for Public Health.
3.20. Potable Water Well. -- Any water well that provides potable water, other than a public water supply for human consumption.
3.21. Public Water System. -- Any water supply or system that regularly supplies or offers to supply water for human consumption through pipes or other constructed conveyances, if serving at least an average of 25 individuals per day for at least 60 days per year, or which has at least 15 service connections, and includes:
3.21.1. Any collection, treatment, storage, and distribution facilities under the control of the owner or operator of the system and used primarily in connection with the system; and
3.21.2. Any collection or pretreatment storage facilities not under such control which are used primarily in connection with the system.
3.21.3. A public water system does not include a system which meets all of the following conditions:
3.21.3.a. It consists only of distribution and storage facilities and does not have any collection and treatment facilities;
3.21.3.b. It obtains all of its water from, but is not owned or operated by a public water system that otherwise meets the definition;
3.21.3.c. It does not sell water to any person; and
3.21.3.d. It is not a carrier conveying passengers in interstate commerce.
3.22. Pump. -- Any mechanical equipment or device used to transfer water from a well.
3.23. Pump Installation Contractor. -- An entity that contracts or agrees to perform a service or function related to any portion of installing a pump or pumping equipment into a water well or public water supply in exchange for money or comparable compensation.
3.24. Pump Installer. -- Any person who engages for compensation in pump or pumping equipment installation, removal, alteration, or repair and who is certified by the Commissioner to practice pump and pumping equipment installation to withdraw water from a well.
3.25. Pumping Equipment. -- Equipment or related materials that are used or intended to assist withdrawing groundwater from a well, including seals and other safeguards to protect the water from contamination; associated fittings; intake and discharge piping; controls to provide sanitary water storage facilities; and deliver water to a distribution piping system.
3.26. Test Wells (Exploratory/ Observation). -- A well that is used to obtain information on groundwater quantity; quality; aquifer characteristics; and availability of production water supply for manufacturing, commercial, and industrial facilities.
3.27. Water Return Well. -- A well constructed for returning water that has passed through the heat pump system to the subsurface.
3.28. Water Well. -- Any excavation or penetration in the ground, whether drilled, bored, cored, driven, washed, jetted, hand dug, or otherwise constructed that enters or passes through an aquifer for purposes that may include, but are not limited to, a potable water supply, exploration for water, industrial, irrigation, commercial, dewatering, or geothermal heat pump wells, and water return wells. This definition shall not include ground water monitoring activities, and all activities for the exploration, development, production, storage, and recovery of coal, oil, and gas and other mineral resources regulated under Chapters 22, 22a, or 22b of the W. Va. Code.
3.29. Water Well Contractor. -- Any individual, partnership, syndicate, association, company, firm, trust, corporation, or any other entity that contracts to drill, construct, alter, or abandon water wells in the State of West Virginia.
3.30. Well Completion Report. -- A record, accurately kept at the time of drilling, showing the depth; thickness and character of the different strata penetrated; location of water-bearing strata; water level; depth; size, type, and amount of casing installed; location of the well; owner; driller; pump installer; date the well was completed; information on any permanent well pumping equipment installed by the well driller or pump installer; and any other information required by the Commissioner.
3.30.1. For geothermal and dewatering wells, one completion form, indicating well locations, is required for a system regardless of the number of wells.
3.30.2. If wells vary in depth or geology, a single representative geologic log for each type is required. Water bearing zones, any voids, and coal seams or voids, or both penetrated shall be documented on the geologic log indicating appropriate depths.
3.31. Well Driller. -- An individual who engages in water well drilling, construction, alteration, or abandonment, or who supervises these activities.
§4-19-4. Permits to Install.
4.1. No person shall drill, construct, alter, or abandon a water well unless the Commissioner, pursuant to this rule, has issued a valid permit, except where the emergency procedures set forth in subsection 4.3 of this rule apply.
4.2. A permit to drill, construct, alter, or abandon a water well shall be obtained jointly by the water well contractor and property owner. Application for the permit shall be made at least 15 calendar days prior to the actual well drilling, construction, alteration, or abandonment unless emergency conditions prevail as set forth in subsection 4.3 of this rule.
4.3. The following applies to emergency water well permits:
4.3.1. The Commissioner may issue an emergency water well permit to minimize actual or potential harm to human health, the environment, or property;
4.3.2. A certified well driller requesting an emergency permit under this section shall contact the Commissioner no later than the next business day after the emergency occurs. The certified well driller shall submit a completed water well permit application and a well completion report to the Commissioner within five calendar days after the initial contact is made; and
4.3.2.a. The application shall include a clear and concise factual description of the nature and scope of the emergency.
4.3.3. The Commissioner, upon issuance of an emergency permit, shall assign to the well driller an emergency permit number and specify the date of approval. The well driller shall make the approved permit available for any on-site inspection by authorized representatives.
4.4. Water wells shall be drilled, constructed, altered, or abandoned in accordance with the Bureau’s rules, Water Well Design Standards, 64CSR46, and Public Water Systems Design Standards, 64CSR77. These standards constitute the minimum standards for the drilling, construction, alteration, or abandonment of a water well, pump, and pumping equipment. Any plans approved by the Commissioner pursuant to this rule shall be in substantial compliance with this rule-mentioned standards. Where applicable, an underground injection control permit shall be obtained from the West Virginia Department of Environmental Protection (DEP) in compliance with DEP’s rule, Underground Injection Control, 47CSR13, prior to construction for a water well.
4.5. Application for a permit to construct, alter, and abandon water wells shall be made to the Commissioner on forms prescribed by the Commissioner. The master water well driller and property owner shall jointly sign this application. By signing the application, the property owner acknowledges that the information provided on the application is true; the property owner is responsible for informing the certified well driller of the location of any known existing or proposed on-site sewage systems and ensuring that these systems are in compliance with all applicable state rules.
4.6. In cases where a water well contractor is changed, the applicable permits shall be reissued to reflect these changes prior to construction. No additional permit fee is required.
4.7. In the event the permit application is denied, the Commissioner shall state, in writing, the one or more reasons for denial and furnish it to the applicant within 15 calendar days from receipt of the permit application.
4.8. A permit, unless revoked, is valid for a period of one year from the date of issuance. In the event the construction or alteration is not completed within that time, the Commissioner may extend the time limit upon written request by the permittee. If the water well is not constructed within the appropriate period, a new well permit shall be obtained from the Commissioner prior to the start of any well drilling activity pursuant to subsection 4.5 of this rule.
4.9. The Commissioner may revoke or deny a permit to install if the applicant or permittee fails to comply with the provisions of the permit, any applicable provision of the rules, or orders issued pursuant thereto. The revocation or denial shall be in writing and shall state the reasons for revocation or denial.
4.10. Any person whose application for a permit to construct a water well system has been revoked or denied, may, within 30 calendar days from receipt of the permit denial or revocation, request a hearing in accordance with section 14 of this rule.
4.11. The following activities may be conducted by a certified well driller without an individual permit issued by the Commissioner:
4.11.1. The repair of any well, including redevelopment, cleaning, or screen replacements, provided that this does not include deepening of the well; and
4.11.2. Acidizing a well.
4.12. The Commissioner may inspect the well site, well logging, grouting, and provide for taking of geologic or water samples, or both.
4.13. The Commissioner may charge a fee for each permitting service listed in Appendix A of this rule.
4.14. Upon issuance of a permit, the Commissioner shall provide the owner and contractor with information prepared by the Commissioner explaining the importance of water well sampling, the procedures for sampling, and how the water can be tested to assure a safe supply of water.
W. Va. Code R. § 64-19-5 Records of Completed Water Wells
5.1. Within 30 calendar days after the water well has been constructed, altered, or abandoned, the certified well driller shall submit a completion report to the Commissioner. The date of construction and time of completion is the date and time the rig is removed or pulled off the borehole or well. The certified well driller who actually performed the construction, alteration, or abandonment of the well or provided the on-site supervision of the well construction, alteration, or abandonment shall sign the completion report. A master well driller is required to sign the completion report when a journeyman well driller conducts the on-site supervision and drilling.
5.2. Completion reports shall be filed for pump installation. When the pumping equipment is installed after the record of completion has been submitted, the record shall be amended by the certified well driller or pump installer and resubmitted to the Commissioner within 30 calendar days of installation of the pumping equipment. The certified well driller or pump installer who actually performed the installation of the pump system shall sign the amended record of completion.
5.2.a. A completion report is not required for the repair of pumps or the replacement of pumps or pumping equipment if the depth of the setting and efficiency are not affected.
5.3. The contractor shall provide two copies of the completion report to the Commissioner and one copy of the completion report to the owner.
W. Va. Code R. § 64-19-6 General Provisions for well driller certifications of the proper class and pump installer certifications
6.1. No person shall drill, construct, alter, or abandon any water well without possessing a valid West Virginia certification of the proper class issued by the Commissioner and complying with the applicable sections of this rule.
6.2. No person shall install, repair, or replace a well pump or well pumping equipment or engage in that business without possessing a valid West Virginia certification of the proper class issued by the Commissioner and complying with applicable sections of this rule. A property owner may be allowed to install the pump system and sign the completion record if, prior to the installation, the property owner passes an examination administered by the Commissioner with a minimum score of 70 percent. This examination shall demonstrate the individual’s knowledge of the applicable rules.
6.3. Well drillers shall be classified into one of three classes: master well driller; journeyman well driller; or an apprentice well driller.
6.3.1. A certified master well driller, after meeting the requirements of subsection 9.2 of this rule, may:
6.3.1.a. Drill, construct, install, repair, replace, alter, or abandon water wells, including public water supply wells;
6.3.1.b. Install or replace well pumping equipment and appurtenances, storage tanks and connecting lines between a well and storage tank;
6.3.1.c. Perform yield and drawdown testing of wells and supervise journeymen well drillers and apprentices;
6.3.1.d. Sign permit applications and certify that a well has been drilled, constructed, installed, repaired, modified, altered, or abandoned in conformance with all applicable state and well drill and pump installation standards;
6.3.1.e. Qualify as a candidate to be appointed to the Advisory Board;
6.3.1.f. Supervise journeymen and apprentices; and
6.3.1.g. Perform field observations to verify qualifications of applicants for all certifications covered by this rule.
6.3.2. A certified journeymen well driller, after meeting all of the requirements of subsection 9.2 of this rule, may:
6.3.2.a. Drill, construct, install, repair, replace, alter, or abandon a well, except a public water system’s supply wells;
6.3.2.b. Install or replace well pumping equipment and appurtenances, storage tanks, and connecting lines between a well and storage tank;
6.3.2.c. Perform yield and drawdown testing of wells; and
6.3.2.d. Supervise apprentices.
6.3.3. An apprentice may perform well drilling as a well driller only under the immediate on-site supervision of a master or journeyman well driller.
6.3.4. A journeyman or master well driller shall be on-site in direct charge of drilling, constructing, altering, or abandoning a water well.
6.4. Pump installers shall be classified into two classes, as a certified pump installer or an apprentice.
6.4.1. A certified pump installer, after meeting the requirements of subsection 9.2 of this rule, may:
6.4.1.a. Install or replace well pumping equipment and appurtenances, pressure tanks, and connecting lines between a well and storage tank;
6.4.1.b. Qualify as a candidate for appointment to the Advisory Board; and
6.4.1.c. Perform yield and drawdown testing of wells.
6.4.2. An apprentice may perform pump installations, and replace appurtenances, pressure tanks, and connecting lines while under the immediate on-site supervision of a master or journeyman well driller, or pump installer.
6.5. A certified pump installer or water well driller shall have in her or his possession a valid certification for the proper class at all times during any operations.
6.6. A certified pump installer or water well driller may run power and control wiring from the disconnect box and breaker panel to water well equipment without obtaining an electrician’s license. A certification issued pursuant to this rule does not authorize the certificate holder to alter the existing electrical service to any building or structure or perform any other electrical work covered by any national, state, or local codes and ordinances, if the latter are more restrictive.
6.7. A certified or licensed plumber may provide plumbing services as a plumbing contractor to install pressure switches, pressure tanks, valves, and pipes without holding certifications from the Commissioner. The certified or licensed plumber shall not break the well seal or alter, cut, or drill into the casing for the purpose of performing repairs to the pumping equipment or appurtenances, unless he or she is certified as a pump installer or passes an examination administered by the Commissioner with a minimum score of 70 percent and completes two hours of continuing education related to pump installation each year as evidenced by submission of a certificate of continuing education completion. This subsection shall not apply to wells utilized by public water systems.
6.8. A certified or licensed electrician may perform electrical contracting, repair, or install pressure switches, control boxes, and other electrical components of the pumping equipment without holding certifications issued by the Commissioner. The electrician shall adhere to these rules for the installation and may not break the well seal or alter, cut, or drill into the casing, unless the certified or licensed electrician is certified as a pump installer.
W. Va. Code R. § 64-19-7 Application and Certification Examination Procedures and Fee Requirements
7.1. An applicant for a West Virginia master well drilling certification shall:
7.1.1. Submit an application on the forms prescribed by the Commissioner and provide evidence of the following:
7.1.1.a. The applicant shall demonstrate two years of relevant work experience with a minimum of 3,000 hours as a journeyman. To demonstrate relevant experience, the applicant shall specify the dates of employment, description of the work, and provide the name of the supervising certified well driller;
7.1.1.b. The applicant shall demonstrate that he or she has resolved any revocation or suspension of a previously issued well drilling certification or of any outstanding violation or fine pursuant to the rule;
7.1.1.c. The applicant shall obtain a minimum grade of 70 percent on each portion of the written examinations and perform a possible field test demonstrating the applicant’s expertise; and
7.1.1.d. The applicant shall be at least 18 years of age.
7.2. An applicant for a West Virginia journeyman well drilling certification shall:
7.2.1. Submit an application on the forms prescribed by the Commissioner and provide evidence of the following:
7.2.1.a. The applicant shall demonstrate relevant work experience of two years with a minimum of 3,000 hours as an apprentice under the supervision of a master or journeyman well driller. To demonstrate relevant experience, the applicant shall specify the dates of employment, description of the work, and provide the name of the supervising certified well driller;
7.2.1.b. The applicant shall obtain a minimum grade of 70 percent on each portion of the written examinations and a possible field test demonstrating the applicant’s expertise;
7.2.1.c. The applicant shall demonstrate he or she has resolved any revocation or suspension of a previously issued well drilling certification or of any outstanding violation or fine pursuant to the rule; and
7.2.1.d. The applicant shall be at least 18 years of age. Provided, That the Commissioner may waive the age requirement if requested to do so, in writing, by the applicant, to a minimum age of 16 and completion of the 10th grade. The minimum age requirements are verified each semester that the student is currently attending school and maintaining a 2.0 average on a 4.0 scale towards graduation requirements. Failure to meet this requirement is grounds for revocation of the certificate.
7.3. An applicant for a West Virginia pump installer certification shall:
7.3.1. Submit an application on the form prescribed by the Commissioner and provide evidence of the following:
7.3.1.a. The applicant shall demonstrate relevant work experience of two years’ experience with a minimum of 1,000 hours as an apprentice under the supervision of a pump installer or a master or journeyman well driller. To demonstrate relevant experience, the applicant shall specify the dates of employment, description of the work, and provide the name of the supervising certified well driller or pump installer;
7.3.1.b. The applicant shall obtain a minimum grade of 70 percent on each portion of the written examinations.
7.3.1.c. The applicant shall be at least 18 years of age. Provided, That, the Commissioner may waive the age requirement if requested to do so, in writing, by the applicant, to a minimum age of 16 and completion of the 10th grade. The minimum age requirements are verified each semester that the student is currently attending school and maintaining a 2.0 average on a 4.0 scale towards graduation requirements. Failure to meet this requirement is grounds for revocation of the certificate.
7.3.2. Pump installers actively engaged in pump installation on or before the effective date of this rule are exempt from the minimum experience and testing requirements. Pump installers seeking to qualify under this provision shall, within one year of the effective date of the rule, submit evidence on the prescribed forms, of 10 pump installations completed within the past two years.
7.4. The Commissioner shall review each application upon receipt of all the information required and either notify the applicant of any deficiencies or notify the applicant of her or his eligibility to take the appropriate examination.
7.5. The Commissioner shall notify, in writing, all applicants of the results of their examinations.
7.6. The Commissioner shall issue the appropriate certification to successful applicants upon receipt of full payment of the appropriate certification fee.
7.7. Certifications are not transferable or assignable and shall automatically become invalid upon suspension or revocation.
7.8. An individual working to obtain current West Virginia driller certification shall register with the Commissioner, on the prescribed forms, within 180 calendar days from the effective date of the rule. The applicant is eligible to become a master water well driller if he or she has two years of experience, obtain a minimum grade of 70 percent on each portion of one or more written examination for the certified master well driller and passes a possible field test demonstrating his or her expertise.
7.9. An individual who holds a legal certification or who has practiced well drilling in accordance with all laws and rules in a state that does not have comparable certification classes, the applicant shall have acquired the following experience:
7.9.1. For a master well driller - Six years of well drilling experience;
7.9.2. For a journeyman driller - Four years of well drilling experience; or
7.9.3. For a pump installer - Three years of pump installation experience; and
7.9.4. For all classes each individual shall have passed all written examination requirements and obtained a minimum grade of 70 percent on each portion of the written examination and any other requirements determined necessary by the Commissioner.
7.10. The Commissioner may review applications from individuals who hold a legal certification for well drilling in another state with comparable certification classes. The Commissioner may grant a comparable certification for the applicant if appropriate.
7.11. All certifications expire two years from the date of issuance and shall be renewed 30 days prior to expiration. The applicant shall submit a completed renewal on forms provided by the Commissioner. Applicants shall provide evidence of bonding and insurance as required by section 8 of this rule. Applicants shall supply evidence of continuing education requirements in accordance with section 9 of this rule for certification renewal.
7.11.1. A certificate holder who fails to renew his or her certification within six months following the expiration date of the certification shall not have the certification reinstated until he or she successfully passes the written examinations or field test prescribed by the Commissioner for applicants for a new certificate.
7.12. A certificate holder may place his or her certification on inactive status for a two-year period if the certificate holder has submitted an application for inactive status at least 60 days before the expiration date of the certificate. Before the Commissioner reactivates the certificate of an inactive-status certificate, that certificate holder shall satisfy any renewal requirements.
7.13. A certificate holder may obtain a duplicate certificate to replace a certificate that has been lost, destroyed, or mutilated if the certificate holder makes a written request to the Commissioner, stating the reason for the request.
7.14. The Commissioner may charge a fee for each certification service provided as listed in Appendix B of this rule.
W. Va. Code R. § 64-19-8 Bonding of Water Well and Pump Installation Contractors
8.1. Each water well and pump installation contractor shall have a current contractor’s bond payable to the Commissioner upon forfeiture and liability insurance coverage effective throughout West Virginia in a form determined by the Commissioner. The Commissioner shall determine the amount of the contractor’s bond, which may not exceed $5,000. Lack of a current contractor’s bond is considered sufficient grounds for denial of a water well or pump installation permit.
8.2. Forfeiture of the contractor’s bond is predicated upon a failure to drill, construct, repair, replace, alter, or abandon a well or upon installation of a pump in a water well in accordance with this rule and the Bureau’s rule, Water Well Design Standards, 64CSR46.
8.3. The surety shall have the option of forfeiting the contractor’s bond or completing the well in accordance with this rule and standards specified in subsection 8.2 of this rule. The Commissioner shall expend all proceeds from a forfeiture due to failure to alter or abandon the well in accordance with applicable rules and standards. The Commissioner shall retain and expend any excess funds collected for the purpose of altering or abandoning water wells in accordance with applicable rules and standards.
8.4. The surety shall have the option of canceling a contractor’s bond after providing notice to the Commissioner at least 30 days prior to cancellation.
8.5. In lieu of the bond required by subsection 8.1 of this rule, the Commissioner may accept an irrevocable letter of credit issued by a bank chartered by the State of West Virginia or a member bank of the federal reserve system. Confirmation of the irrevocable letter of credit shall be in writing and shall be signed by the issuing or confirming bank.
W. Va. Code R. § 64-19-9 Continuing Education Program and Requirements
9.1. The continuing education program shall be a formal offering of instruction or information to certificate holders and registrants for the purpose of maintaining, enhancing, and developing the skills necessary for the protection of groundwater and the health and general welfare of the citizens and to increase the competence of well drillers and pump installers.
9.2. A certified master well driller shall show proof of six hours of continuing education related to water well drilling every two years. Additionally, for a certified master well driller to install pumps, he or she shall show proof of four hours of continuing education related to pump installation every two years. A certified journeyman driller shall show proof of four hours of continuing education every two years. For a certified journeyman driller to install pumps, the journeyman driller shall show proof of two hours of continuing education related to pump installation every two years. A certified pump installer shall show proof of four hours of continuing education every two years to maintain the certification. Each certificate holder shall submit a copy of the certificates of completion as proof of meeting the continuing education requirements.
9.3. Only courses or programs designated or approved by the Commissioner are acceptable for continuing education.
9.4. To obtain pre-approval of a course the sponsor or attendee shall submit the following information to the Commissioner: a written course description, which includes the names and qualifications of the presenters; the time and location of the course; the proposed number of hours; and the program objectives.
9.5. Programs for continuing education units may be held in state or out of state. Approved topics include water wells or pump system technology, science, health, sound business practices, rule compliance, and industry requirements, including worker health and safety.
9.6. Program sponsors shall provide proof of attendance to attendees.
W. Va. Code R. § 64-19-10 Identification Numbers of Water Well Rigs and Well Head
10.1. All water well rigs shall be clearly marked with legible and plainly visible identification numbers at all times.
10.2. The identification number to be used on water well drilling rigs is the certification number of the water well driller at the well site who is responsible for the water well drilling operations.
10.3. Certification numbers shall be printed on each side of every water well drilling rig in numerals not less than two inches high in a color sufficiently different from the color of the vehicle or equipment so that the certification number is plainly legible.
10.4. Each well drilling contractor shall securely attach a metal tag or engraved well cap to the wellhead containing the following information: the contractor's name, address, and permit number; the depth of the well; and the date of construction or alteration.
W. Va. Code R. § 64-19-11 Advisory Board
11.1. The Commissioner may establish an advisory board and designate the chairman of the board.
11.2. The advisory board membership shall consist of, but not necessarily be limited to, the following members:
11.2.1. Three certified master well drillers;
11.2.1.a. These three members shall represent and have actual experience from the various geologic areas of the state and be familiar with the various appropriate drilling methods used in different regions of West Virginia.
11.2.2. One certified pump installer;
11.2.3. One employee of the West Virginia Bureau for Public Health;
11.2.4. One representative from a local health department;
11.2.5. One employee of the West Virginia Department of Environmental Protection;
11.2.6. One individual who is not employed by the state and who has no commercial or economic involvement in well drilling or pump installation;
11.2.7. One academic or technical expert who is either:
11.2.7.a. Employed by the West Virginia Geological Survey or the United States Geological Survey;
11.2.7.b. A professional hydrologist or hydrogeologist; or
11.2.7.c. A geology or hydrogeology professor from a college or university in West Virginia.
11.3. The Water Well Advisory Board has the following duties:
11.3.1. Recommend changes in the certification program as needed to the Commissioner;
11.3.2. Recommend written tests and field tests required for certification and assist in the preparation and administration of written tests, as appropriate;
11.3.3. Recommend continuing education classes and instructors; and
11.3.4. Perform other duties that may be assigned by the Commissioner.
W. Va. Code R. § 64-19-12 Inspections and Water Sampling
12.1. The Commissioner may make as many inspections as necessary, during the construction, installation, modification, or operation of a water well, pump, and pumping equipment to determine compliance with the applicable provisions of this rule and the Bureau’s rule, Water Well Design Standards, 64CSR46. An inspection may include, without limitation, water sampling for the detection of any contaminants, the documentation of a violation of construction standards, technical procedures, or any other requirements established under the rule. The owner or occupant of a dwelling, establishment, or land where a water well is located shall provide the Commissioner access for making the inspection. The Commissioner shall record the findings of inspections on forms prescribed for that purpose.
W. Va. Code R. § 64-19-13 Penalties, Suspension, and Revocation of Certifications
13.1. Persons who violate the provisions of this rule are subject to the civil and administrative penalties of W. Va. Code §6-1-9a and to potential civil or criminal penalties under W. Va. Code §16-1-9, §16-1-9a, and §16-1-18.
13.2. The Commissioner may suspend, revoke, or deny certification of a driller or pump installer if the information on the application form is incomplete, inaccurate, false, misleading, or indicates that the provisions of this rule cannot be met. The Commissioner may revoke or suspend the certification of a driller or pump installer who knowingly violates this rule.
13.3. When certification has been denied, suspended, or revoked, the person affected shall immediately discontinue the drilling, altering, constructing, and abandonment of water wells.
13.4. A denial, suspension, or revocation of certification shall be in writing from the Commissioner and shall state specific reasons for the denial, suspension, or revocation.
13.5. The Commissioner shall send a written notice of the suspension or revocation of a certification at least 10 calendar days prior to the actual revocation or suspension.
W. Va. Code R. § 64-19-14 Administrative Due Process
14.1. Administrative Due Process. -- Any person adversely affected by the enforcement of this rule desiring a contested case hearing to determine any rights, duties, interests, or privileges shall do so in the manner prescribed in the West Virginia Department of Health’s Procedural Rule, Rules of Procedure for Contested Case Hearings and Declaratory Rulings, 64CSR1.
Appendix A. Permitting Fees.
- Construction /Installation Permits A. Heat exchange wells: Permit Fee is determined by the ton rating of the heat pump machine. When more than one heat pump machine is hooked together, the cumulative total of the ton rating is used to determine the fee: One to fifty ton heat pump system $150; over fifty ton system $300.
Appendix B. Certification Fees.
- Master Well Driller: Initial and Renewal Fee for Certification - $300 2. Journeyman Well Driller: Initial and Renewal Fee for Certification - $200 3. Pump Installer: Initial and Renewal Fee for Certification - $300 4. Reactivation of Status Fee - $350 5. Examination Fee - $25 Duplicate Certificate - $2
Series 21 Child Care Centers
W. Va. Code R. § 64-21-1 General
1.1. Scope. -- This legislative rule establishes the environmental health requirements for the construction and operation of child care centers.
1.2. Authority. -- W. Va. Code '16-1-7.
1.3. Filing Date. -- June 16, 1997.
1.4. Effective Date. -- June 23, 1997.
1.5. Supersession of Former Rule. -- This rule repeals and replaces W. Va. Division of Health Legislative Rule, Child Care Centers, 64 CSR 21, effective March 15, 1974.
1.6. Applicability. -- This rule applies to the owners and operators of child care centers.
1.7. Enforcement. -- This rule is enforced by the director of the division of health.
W. Va. Code R. § 64-21-2 Definitions
2.1. Approved. -- A procedure of operation, installation or construction which is in accordance with the standards, specifications, and instructions established by the division of health.
2.2. Child Care Center. -- Any child care facility providing nonresidential child care for seven (7) or more children for all or part of a day. The term Achild care center@ includes: day care centers, family day care facilities, nursery schools, and preschools. AChild care center@ does not include:
2.2.a. A kindergarten, preschool or school education program operated by a public school, accredited by the state department of education;
2.2.b. An individual or facility which offers occasional, temporary care of children for brief periods while parents are shopping, engaging in recreational activities, attending religious services or engaging in other business or personal affairs;
2.2.c. Summer recreation camps operated for children attending sessions for periods not exceeding thirty (30) days;
2.2.d. Hospitals or other medical facilities which are primarily used for temporary residential care of children for treatment, convalescence or testing; or
2.2.e. Persons providing family day care solely for children related to them, including grandparents, aunts and uncles.
2.3. Day Care Center. -- A child care center which provides nonresidential child care for thirteen (13) or more children on a nonresidential basis.
2.4. Director. -- Director of the division of health or his or her lawful designee.
2.5. Disinfect. -- To eliminate virtually all germs from inanimate surfaces through the use of chemicals (e.g., products registered with the U.S. Environmental Protection Agency as Adisinfectants@) or heat. In the child care environment, a solution of one fourth (3) cup household liquid chlorine bleach added to one (1) gallon of tap water and prepared fresh daily is an effective disinfectant for environmental surfaces and other inanimate objects, if the surfaces have been cleaned.
2.6. Family Day Care Facility. -- A child care center which is used to provide nonresidential child care for seven (7) to twelve (12) children, including children who are living in the household who are less than six (6) years of age. No more than four (4) of the total number of children may be less than twenty-four (24) months of age.
2.7. Health Officer. -- The director of the division of health or the executive officer of the local board of health or his or her lawful representative.
2.8. Permit. -- A written document, issued by the division of health giving a designated person permission to operate, construct, extend, alter or modify a building or structure to be used, or being used, as a child care center.
2.9. Person. -- Individual, partnership, association, syndicate, company, firm, trust, corporation, government corporation, institution, department, division, bureau, agency or any entity recognized by law.
W. Va. Code R. § 64-21-3 Permits, Hearings, Notices, Orders
3.1. Construction and Modification.
3.1.a. Except for minor repairs, no person shall construct a building or structure to be used as a child care center, or extend, alter or modify any structure used or to be used as a child care center without first making written application to the division of health and receiving a permit for the child care center. A person shall not begin construction, extension, alteration, or modifications until the division has issued a permit for the construction.
3.1.b. The division shall not issue a permit for the construction, extension, alteration, or modification of a child care center until it receives an application for a construction permit and detailed plans and specifications of the child care center for review and approval.
3.1.c. The applicant shall submit a written permit application on a form prescribed by the division. The form shall be signed by the applicant or his or her authorized agent and shall contain all information requested by the division to enable it to determine if the child care center construction, extension, alteration, or modification is or will be in compliance with the applicable provisions of this rule.
3.1.d. When upon review of the plans, specifications, and application for a permit, the division of health is satisfied that the proposed construction, extension, alteration, or modification of the child care center is satisfactory, it shall issue a permit. If the construction, extension, alteration, or modification activities have not begun within six (6) months from the date of issuance of a permit, the permit automatically expires.
3.1.e. The application, plans, and specifications shall include, but not be limited to: a plot layout; floor plans; building specifications; type of material used; a list of food service equipment; the type of potable and waste water treatment systems; and the type of heating and ventilation systems.
3.1.f. The applicant shall submit plans, specifications, and an application for a permit at least forty-five (45) days prior to the date that construction, extension, alteration, or modification is to begin.
3.1.g. The division of health shall deny permission to construct, extend, alter, or modify the building or structure, if the information on the application, plans, specifications or supporting documentation is incomplete, inaccurate, false or misleading, or indicates that the applicable provisions of this rule cannot be met.
3.1.h. The child care center shall only be constructed, extended, altered or modified in accordance with the plans and specifications approved by the division of health. Prior to implementing a deviation from the approved plans and specifications, the applicant shall obtain written approval from the division.
3.2. Permit to Operate.
3.2.a. No person shall operate a child care center unless the person has in his or her possession a valid permit issued by the health officer to operate a specific child care center.
3.2.b. The applicant shall submit a written permit application to the health officer on a form prescribed by the division. The form shall be signed by the applicant or his or her authorized agent and shall contain all information requested by the division to enable it to determine if the child care center and its operation are in compliance with the applicable provisions of this rule.
3.2.c. The applicant shall submit an application for a permit at least fifteen (l5) days before the actual or proposed operation of the child care center is scheduled to begin.
3.2.d. The health officer shall deny a permit if the information on the application form is incomplete, inaccurate, false or misleading or indicates that the applicable provisions of this rule cannot be met.
3.2.e. Only persons who comply with the applicable provisions of this rule are entitled to retain a permit.
3.2.f. Child care centers in operation at the time this rule becomes effective, which meet all applicable prior rules, are eligible for a permit to operate. Any construction, extension, modification or alteration taking place after the effective date of this rule in child care centers permitted under this subdivision shall comply with all applicable provisions of this rule.
3.2.g. Child care centers put into operation after the effective date of this rule shall comply in full with all applicable provisions of this rule.
3.2.h. Permits are not transferable or assignable and automatically become invalid upon a change of ownership or upon suspension or revocation.
3.2.i. A permit to operate expires at midnight on the thirty first day of December following the date of issuance.
3.2.j. In the event of an intended change or actual change in ownership of a child care center, the applicant shall submit an application for a permit to operate at least fifteen (l5) days prior to the date of the proposed or actual change.
3.2.k. The health officer may be suspend or revoke a permit if he or she finds that the child care center is being maintained or operated in violation of this rule or any applicable law, rule or ordinance.
3.2.l. The health officer shall not reinstate a permit to operate until he or she determines by an inspection that the child care center is in compliance with all applicable provisions of this rule and any orders, rules or instructions issued by the health officer.
3.2.m. The operator shall post the operational permit in a conspicuous place within the child care center, and the permit shall be readily available to the health officer.
3.3. Hearings, Notices and Orders.
3.3.a. Any person whose application for the construction, extension, alteration, or modification of a child care center has been denied may petition and shall be granted a hearing on the matter within ten (l0) days after the health officer has received a written petition requesting a hearing.
3.3.b. Any person whose application for a permit to operate a child care center has been denied, or whose permit has been suspended or revoked may petition and shall be granted a hearing on the matter within ten (l0) days after the health officer has received written petition for the hearing.
3.3.c. When a health officer finds insanitary or other conditions which constitute an immediate substantial hazard to public health at a child care center, he or she may, without warning notice or a hearing, issue a written order to the operator. The order shall cite those conditions and shall specify the corrective action to be taken by the child care center and the time period in which the action shall be completed. When necessary, the order shall state that the permit to operate the child care center is immediately suspended.
W. Va. Code R. § 64-21-4 Inspections
4.1. The health officer shall inspect each child care center at least once each six (6) months. The health officer shall also make additional inspections needed to determine satisfactory compliance with the provisions of this rule and any orders, notices, instructions, or specifications issued pursuant to this rule.
4.2. The health officer may consider any consecutive violation of the same item or items of this rule as cause for the immediate suspension of a permit to operate.
4.3. The operator shall post a copy of the inspection report within the child care center.
4.4. The owner, operator or person in charge of a child care center, shall provide the health officer with free access to the entire premises for the purpose of inspection, and shall furnish all requested information to make the inspection complete.
W. Va. Code R. § 64-21-5 General Building Requirements
5.1. Location; Structure; Size.
5.1.a. Child care centers shall be located in a relatively noise and pollution free environment.
5.1.b. Child care center buildings or structures shall be of sound structure and maintained in good repair.
5.1.c. All painted surfaces shall be free of lead pigment and other toxic materials.
5.1.d. Usable floor space of thirty-five (35) square feet per child shall be provided and available for children=s activities, exclusive of halls, bathrooms, the kitchen, office space, or storage areas.
5.2. Floors; Walls; Ceilings.
5.2.a. Floors, walls and ceilings shall be of easily cleanable construction.
5.2.b. Toilet rooms and areas housing food service facilities shall have moisture-resistant, nonabsorbent floors.
5.2.c. Toilet rooms and areas housing food service facilities shall have water-resistant walls to a minimum level of four (4) feet above floor level.
5.2.d. Toilet rooms and areas housing food service facilities shall provide a coved juncture between the floor and wall.
5.2.e. Carpeting shall be securely attached or of a non-skid nature.
5.2.f. Carpeting shall not be used in toilet rooms or areas housing food service facilities.
5.2.f.1. In family day care facilities carpeting may be used in kitchen and dining areas if it is easily cleanable and kept clean and in good repair.
5.3. Heating; Ventilation.
5.3.a. All rooms shall have approved ventilation either by natural or mechanical means. Fans shall have shields with openings less than one-half inch or be out of the reach of children.
5.3.b. Child care centers shall be equipped with approved heating units sufficient to provide a temperature of at least sixty-eight degrees Fahrenheit (68F) at floor level in all rooms used by children.
5.3.c. Unguarded open-face heaters are prohibited.
5.3.d. Oil and gas fired heating devices shall be properly vented to the outside air.
5.3.e. Shielding or other effective means shall be used to protect the children from direct contact with radiators, registers, hot water pipes and similar hazards.
5.3.f. All rooms used by children shall have a thermometer which shall be located approximately thirty (30) inches above floor level. Thermostats are not acceptable in lieu of thermometers.
5.4. Insect and Rodent Control.
5.4.a. All buildings or structures shall be of rat-proof construction.
5.4.b. All doors opening to the outside shall be close-fitting. Screen doors or doors used in lieu of screen doors shall be self-closing.
5.4.c. All openings to the outer air shall be effectively protected against the entrance of insects.
5.4.d. The child care center shall be free of insects and rodents at all times.
5.4.e. Only those insecticides and rodenticides approved by the U. S. Environmental Protection Agency shall be used in child care centers.
5.5. Lighting.
5.5.a. Play and activity surfaces shall have a minimum of fifty (50) foot candles of illumination at floor level. All other areas shall have at least thirty (30) foot candles of illumination at floor level.
5.5.b. Lighting may be by either natural or artificial means or both.
5.5.c. All light bulbs and fluorescent tubes shall be protected by effective shields.
5.6. Plumbing.
5.6.a. All plumbing shall meet the requirements of local plumbing codes or ordinances, or in their absence, the state building code.
5.6.b. Cross-connections and potential back siphonage possibilities are prohibited.
5.7. Toilet, Lavatory, and Bathing Facilities.
5.7.a. Toilet rooms shall be provided and shall be easily accessible to children.
5.7.b. In day care centers, separate and private toilet facilities shall be provided for males and females who are six (6) years of age or older.
5.7.c. One (1) flush toilet and one (1) lavatory shall be provided for each fifteen (15) children or fraction thereof, excluding children in diapers who are not receiving toilet training.
5.7.d. In day care centers, a hand washing sink shall be located in the diaper changing area. In family day care facilities, a hand washing sink shall be readily accessible to the diaper changing area.
5.7.e. Toilet fixtures shall be sized so that they may be used by children without assistance, or step stools and/or modified toilet seats which are safely constructed and can be cleaned easily may be used in lieu of specially sized toilet fixtures.
5.7.f. Lavatories shall be provided in or immediately adjacent to all toilet rooms. Each lavatory shall have mixing faucets, or be provided with tempered water. All lavatories shall be provided with soap and single service sanitary towels.
5.7.g. Waste receptacles shall be provided adjacent to lavatories for used paper towels.
5.7.h. If provided, separate adult employee toilet rooms shall have a minimum of one (1) flush toilet. At least one (1) lavatory shall be located within or immediately adjacent to the toilet room.
5.7.i. Adult employee toilet rooms shall meet the requirements of subdivisions 5.7.f and 5.7.g of this rule.
5.7.j. All toilet rooms shall have a covered waste container.
5.7.k. If night-time care is provided, a bathtub or shower shall be provided as well as age-appropriate bathing facilities for children of toddler age or younger.
5.7.k.1. No child under age six (6) shall be left unsupervised while bathing.
5.7.k.2. Soap and clean, individual washcloths and towels shall be provided for each child.
5.7.k.3. Bathtubs and showers shall be equipped to prevent slipping.
W. Va. Code R. § 64-21-6 Activity Areas and Equipment
6.1. All activity equipment shall be free of safety hazards, shall be of smooth construction and, where applicable, easily cleanable. Activity equipment shall include, but not be limited to: toys, furnishings, tables, chairs, cots and similar equipment.
6.2. Usable outdoor play space of seventy-five (75) square feet per child shall be provided on the premises or within walking distance of the facility. Play times may be staggered, and space may be based on the number of children using the area at one (1) time.
6.2.a. Outdoor play spaces shall be well-drained and free of litter, solid waste and refuse, ditches, abandoned cars, used appliances, animal feces, toxic plants, or other conditions presenting a hazard.
6.2.b. Outdoor play spaces provided by day care centers shall be fenced or have natural barriers such as hedges or stationary walls at least three (3) feet high.
6.2.c. In family day care facilities, all areas accessible to the outdoor play area which are unsafe for children shall be fenced off or have natural barriers at least three (3) feet high to protect children. Unsafe areas may include, but are not limited to: steep grades; cliffs; open pits; swimming pools; high voltage boosters; propane gas tanks; streets; roads; driveways; railroad tracks; and parking lots.
6.2.d. Outdoor equipment used for climbing and similar play activities shall be installed to prevent tipping or collapse. Swings, slides, and climbing equipment shall not be placed over or immediately adjacent to concrete, asphalt, brick, or similar hard surfaces.
6.3. Sandboxes shall be covered when not in use.
6.4. Wading pools are prohibited unless they are an integral part of a swimming pool which complies with the division of health rule, Swimming Pool and Bathing Beach, 64 CSR 16.
W. Va. Code R. § 64-21-7 Animals
7.1. Animals are permitted on child care premises.
7.2. Animals and their quarters shall be kept in a clean condition at all times.
7.3. Wild, dangerous, aggressive or obviously ill animals are prohibited.
7.4. Aquariums shall be under the supervision of the child care staff, located in the activity areas and kept out of reach of children.
7.5. Dogs and cats shall be currently vaccinated against rabies, distemper, hepatitis, and leptospirosis.
7.6. In day care centers, the outdoor quartering areas of dogs and cats shall be completely separate from children's outdoor activity areas.
7.7. Indoor animal quarters and litter boxes shall not be located in food preparation, storage, or serving areas.
7.8. Live animals, including birds and turtles, shall be excluded from food preparation, storage and serving areas, and in-use dining areas. This exclusion does not apply to edible fish, crustacea, shellfish, or to fish in aquariums.
W. Va. Code R. § 64-21-8 Bedding and Sleeping Areas
8.1. The child care center shall provide each child who takes a nap with an individual bed, sturdy cot, crib, couch, baby bed, playpen, or mat. In family day care facilities, siblings may share double beds.
8.2. The child care center shall provide separate cribs for infants who are not yet able to climb. Cribs shall be spaced a minimum of twenty-four (24) inches apart on all sides. Bars on cribs shall be no farther apart than two and three-eights (2 d) inches, and crib sides shall be secure and high enough to prevent accidents.
8.3. The child care center shall provide individual sheets and covers for each child. Sheets and covers shall be laundered at least weekly or whenever soiled or prior to use by another child.
8.4. Mattresses, mats, cots, and other sleeping surfaces shall be water-proof or shall have a water-proof cover.
8.5. Stackable cribs are prohibited. The upper levels of double-deck beds shall not be used by children under nine (9) years of age.
W. Va. Code R. § 64-21-9 Diaper Changing and Toilet Training
9.1. Children shall be diapered or have soiled underwear changed in an established diaper changing area. The changing area shall not be located in food preparation areas.
9.2. Staff shall change children diapers or soiled underwear on a clean, safe, impervious, nonabsorbent surface which is used for no other purpose.
9.3. Staff shall clean the child=s perineal (urinary and anal) area with disposable wipes.
9.4. After removing a soiled diaper and before putting a fresh diaper on a child, staff members shall wipe their own hands with a pre-moistened towelette or a damp paper towel.
9.5. Both the child=s and the staff member=s hands shall be thoroughly washed after each diaper change. If disposable gloves are used, they must be discarded immediately and hands washed.
9.6. Changing tables and surfaces shall be cleaned and disinfected after each use by cleaning to remove visible soil, followed by wiping with an approved disinfectant solution, whether or not disposable, nonabsorbent paper is used. If disposable paper is used, it shall be discarded immediately after each diapering.
9.7. Soiled cloth diapers and/or soiled training pants shall be stored in a labeled container with a tight-fitting lid provided by a commercial diaper service or in a sealed plastic bag which is sent home with the child at the end of the day. If diapers are laundered by a commercial diaper service, the service shall be accredited by the Diaper Service Accreditation Council. Feces from soiled cloth diapers or training pants shall be disposed of by dumping in a toilet.
9.8. Soiled disposable diapers shall be stored in conveniently located, washable, plastic-lined, tightly covered waste containers. Each container shall be labeled and kept clean and free of buildup of soil and odor.
9.9. Toilet training chairs, if used, shall be of easily cleanable construction and after each use shall be emptied into a toilet, and thoroughly cleaned and sanitized in a utility sink.
9.10. Hand washing sinks shall not be used for rinsing soiled diapers or clothing or for cleaning toilet training equipment.
W. Va. Code R. § 64-21-10 Employee Health
10.1. All staff members shall wear clean outer garments, maintain a high degree of personal cleanliness, and conform to good hygienic practices while on duty.
10.2. Staff members shall not use tobacco in any form while engaged in any food service activities, feeding children or administering to the children's needs.
10.3. Smoking is prohibited in children's areas.
10.4. No staff member while affected with any disease in a communicable form, or while a carrier of such a disease, or while affected with boils, infected wounds, sores, or a respiratory infection shall work in any capacity in which there is a likelihood of the staff member transmitting the disease or condition to other persons. No person known or suspected of being affected with any such disease or condition shall be employed in any area or capacity in which there is a likelihood of the person transmitting the disease or condition to other persons. In family day care facilities, appropriate measures shall be taken to protect staff and children from the direct or indirect transmission of diseases from non-staff household members.
10.5. The staff shall employ universal precautions for protection from disease and infection.
10.5.a. Spills of body fluids, which include urine, feces, blood, saliva, nasal discharge, eye discharge, and injury or tissue discharges, shall be cleaned up immediately.
10.5.b. Surfaces soiled by spills of vomit, urine, feces, blood or blood-containing body fluids or by spills due to injury and tissue damage shall be cleaned and disinfected.
10.5.c. Persons cleaning contaminated areas shall avoid exposure of open skin sores or mucous membranes to blood or blood-containing body fluids.
10.5.d. Blood-contaminated material and diapers shall be disposed of in a plastic bag with a secure tie.
10.5.e. Mops shall be cleaned with a disinfectant solution.
W. Va. Code R. § 64-21-11 Food Service
11.1. Child care centers shall comply with the division of health=s rule, Food Service Sanitation Rules, 64 CSR 17, except as specified in Section 11.2 of this rule.
11.2. Family day care facilities may use an on-site kitchen which complies with the following requirements:
11.2.a. All food preparation, service and storage areas, and all equipment and utensils shall be kept clean and in good repair;
11.2.b. Food contact surfaces of equipment and utensils shall be non-toxic, easily cleanable, and cleaned and sanitized after each use;
11.2.c. Dish washing facilities shall be provided and methods used to effectively remove food soil and sanitize dishes, utensils and equipment. Except for fixed equipment and utensils too large to be cleaned in sink compartments, dishes, utensils and equipment shall be washed in a mechanical dishwasher capable of sanitizing, or washed in a hot detergent solution, rinsed free of detergent and abrasives, and sanitized by one (1) of the following methods:
11.2.c.1. Immersion for at least thirty (30) seconds in water at a temperature of one hundred seventy degrees Fahrenheit (170F);
11.2.c.2. Immersion for at least one (1) minute in water at a temperature of at least seventy-five degrees Fahrenheit (75F) and containing fifty (50) parts per million of available chlorine (approximately one (1) tablespoon liquid household bleach per gallon of water); or
11.2.c.3. Immersion in a clean solution containing any other approved chemical sanitizing agent;
11.2.d. Dishes, utensils and equipment shall be air dried;
11.2.e. Food shall be in sound condition, free from spoilage, filth or other contamination and shall be obtained from approved sources. Home-canned food is prohibited except for jams, jellies, preserves, apple butter, syrup and honey. Fluid milk and milk products shall be pasteurized and packaged in an approved milk processing plant;
11.2.f. Adequate refrigeration equipment shall be provided and used for perishable foods and shall be capable of maintaining food temperatures at forty-one degrees Fahrenheit (41F) or below;
11.2.g. Food shall be prepared in a sanitary manner and protected at all times from potential contamination, including dust, insects, rodents, unnecessary handling, coughs and sneezes, overhead leakage, and unclean equipment and utensils;
11.2.h. Potentially hazardous foods, such as beef, poultry, and eggs, shall be thoroughly cooked;
11.2.i. Prepared foods shall be served immediately, refrigerated, or held at one hundred forty degrees Fahrenheit (140F) or above;
11.2.j. Food service workers shall thoroughly wash their hands and the exposed portions of their arms with soap and warm water before starting to work, during work as often as is necessary to keep them clean, and after smoking, eating, drinking, or using the toilet; and
11.2.k. Food service workers shall employ good hygienic practices, shall wear clean clothing and hair restraints, and shall not use tobacco products in the food preparation and service areas.
11.3. When required by the local health department having jurisdiction over the county in which the center is located, all persons engaged in food service activities shall have valid food service workers= permits.
W. Va. Code R. § 64-21-12 Garbage and Refuse Disposal
12.1. All garbage and refuse shall be stored in approved watertight and vermin-proof containers.
12.2. When not in constant use, garbage and refuse containers shall be covered with tight-fitting lids.
12.3. Garbage and refuse shall be removed from the premises weekly, or more often, if necessary.
12.4. Except for family day care facilities, a concrete platform or a metal rack is required for outside storage of garbage and refuse containers.
12.5. Garbage and refuse containers shall be cleaned after each emptying.
12.6. If garbage and refuse container cleaning operations are conducted outside, then a frost-proof hose bibb shall be provided.
W. Va. Code R. § 64-21-13 Hand Washing
13.1. Staff members shall wash their hands thoroughly in an approved lavatory before starting work, after changing a diaper and otherwise as often as necessary to remove soil and prevent contamination. No staff member shall resume work after visiting the toilet room without first washing his or her hands.
13.2. Children=s hands shall be washed before and after eating meals and snacks, after handling pets or other animals, after visiting the toilet room, and before any food service activity, including setting the table.
W. Va. Code R. § 64-21-14 Housekeeping and Sanitation
14.1. All areas and equipment of the child care center shall be kept clean and in good repair and in a neat and orderly condition at all times. Indoor environmental surfaces associated with children=s activities, such as table tops, shall be cleaned and disinfected when they are soiled or at least once weekly.
14.2. Toys that are placed in children=s mouths or are otherwise contaminated by body secretions or excretions shall be set aside to be cleaned and disinfected before handling by another child. Machine-washable cloth toys can be used and shall be machine-washed when contaminated.
14.3. All frequently touched toys in rooms in which infants and toddlers are cared for shall be cleaned and disinfected daily. Toys in rooms in which older, non-diapered children are cared for shall be cleaned weekly and when soiled. The use of soft, non-washable toys for infants and toddlers shall be limited to personal use articles that are not shared between children.
14.4. Toilet rooms, flush toilets, toilet training equipment, and fixtures shall be cleaned and sanitized at least daily and when obviously soiled.
14.5. Rooms shall not be routinely cleaned while occupied by children.
W. Va. Code R. § 64-21-15 Laundry
15.1. In day care centers, laundry done on the premises may not be done in children=s activity areas or in food preparation, service or storage areas.
15.2. Soiled laundry shall be stored in nonabsorbent easily cleanable covered containers.
15.3. Soiled and clean laundry shall not be stored or placed in the same container or on a common table or shelf.
15.4. Clean laundry shall be stored in a manner to protect it from being soiled or contaminated prior to use.
15.5. Laundry shall either be mechanically washed and dried or mechanically washed, rinsed in a chemical sanitizing solution, and air-dried.
W. Va. Code R. § 64-21-16 Safety
16.1. All necessary precautions shall be taken to insure an accident-free environment for the children.
16.2. Children shall be supervised at all times in accordance with the applicable staff/child ratios set forth in the division of human services rules, Family Day Care Facilities, 78 CSR 18, and Day Care Centers, 78 CSR 1.
16.3. Stairways, walks, corridors and all other areas of the child care center shall be free of ice, snow, physical obstructions, or any other item which may be a safety hazard. Porches, balconies, decks, or platforms elevated more than three (3) feet above the ground shall be equipped with secure child-proof railings or barriers. Stairways shall be provided with railings and with barriers or safety gates at the top and bottom whenever infants, toddlers or preschool children are in care.
16.4. A first aid kit shall be provided on the premises and shall be readily available at all times. The minimum contents of the kit shall include, but not be limited to, band aids; thermometer; gauze; tape; scissors; tweezers; disposable, nonporous gloves; a first aid guide; and syrup of ipecac. Syrup of ipecac shall be used only with prior authorization from the parent and at the direction of a poison control center or the child=s physician. First aid supplies shall not be accessible to the children in care. Staff shall take a first aid kit on all trips away from the facility.
W. Va. Code R. § 64-21-17 Sewage System
17.1. Sewage and excreta disposal systems shall comply with the division of health=s rule, Sewage Systems, 64 CSR 9.
17.2. Sewage and excreta disposal systems shall be kept in good repair and properly maintained and operated.
W. Va. Code R. § 64-21-18 Storage
18.1. Approved storage facilities shall be provided for, but not limited to, the following items: food stuffs, utensils, toys, work materials, cleaning supplies, clothing, linens, medicines, toxic materials, and all items which may be hazardous to children.
18.2. Poisons and other potentially hazardous items shall be inaccessible to children and stored in their original containers.
W. Va. Code R. § 64-21-19 Water Supply
19.1. Potable water shall be provided from an approved source in sufficient quantity to meet the needs of the center.
19.1.a. If the center is served by a public water system, it shall be in compliance with the division of health=s rule, Public Water Systems, 64 CSR 3.
19.1.b. If the center is not served by a public water system, the water supply shall be approved by the health officer.
19.2. Hot and cold running water, with a minimum pressure of twenty pounds per square inch (20 p.s.i.), shall be provided in all areas where food is prepared, at utility sinks, lavatories, and at all hand washing, bathing, dish washing, and laundry facilities. Where the water will be in direct contact with children, the temperature shall not exceed one hundred twenty degrees Fahrenheit (120F).
19.3. Drinking fountains, if provided, shall be of the angle-jet type with a non-oxidizing mouth guard.
19.3.a. Drinking fountains shall be easily accessible to the children and the water pressure at the fountains shall be properly regulated.
19.3.b. Drinking fountains, if provided, shall be at the ratio of one (1) per each forty (40) children or fraction thereof.
19.3.c. Drinking cups shall be dispensed from an approved sanitary single service dispenser. This does not preclude the use of properly washed and sanitized glasses.
W. Va. Code R. § 64-21-20 Penalty for Violating Provisions of Regulations
20.1. Any person who violates any provision of this rule is guilty of a misdemeanor and shall upon conviction be punished by a fine of not more than two hundred dollars ($200) or by imprisonment for not more than thirty (30) days or both fine and imprisonment.
20.2. Each day's failure to comply with any applicable provision of this rule constitutes a separate offense.
W. Va. Code R. § 64-21-21 Administrative Due Process
Those persons adversely affected by the enforcement of this rule desiring a contested case hearing to determine any rights, duties, interests or privileges shall do so as prescribed in the division of health=s administrative rule, Rules of Procedure for Contested Case Hearings and Declaratory Rulings, 64CSR 1.
The Department of Health and Human Resources (DHHR) was created by the Legislature's reorganization of the executive branch of State government in 1989. The Department of Health was renamed the Division of Health and made a part of the DHHR (W. Va. Code ' 5F-1-1 et seq.). Administratively within the DHHR the Bureau for Public Health through its Commissioner carries out the public health function of the Division of Health.
The permit issued under this rule is one of several approvals required in order for a child care center (a day care center, a family day care facility, or other type of child care center) to obtain a license or certification to operate issued by the division of human services.
64CSR21
Series 23 Radiological Health Rule
W. Va. Code R. § 64-23-1 General
1.1. Scope. -- This legislative rule establish the requirements that shall be applied to the use of sources of ionizing radiation to reduce, to an acceptable level, the risk that any person is likely to be injured by such radiation. This legislative rule is intended to be consistent with the recognized beneficial uses of sources of ionizing radiation. This legislative rule provides for the registration and applicable safety requirements of all sources of ionizing radiation including naturally occurring radioactive materials, accelerator produced radioactive material, and radiation producing equipment. This rule should be read in conjunction with the provisions of W. Va. Code §16-1-7 et seq.
1.2. Authority. -- This legislative rule is issued under the authority of and are related to W. Va. Code §16-1-7 of 1931, as amended.
1.3. Filing Date. -- June 8, 2001.
1.4. Effective Date. -- July 1, 2001.
1.5. Repeal of Former Rule. -- This legislative rule repeals and replaces WV 64 CSR 23 “Radiological Health Rule and Related Documents Filed in the Secretary of State’s Office” filed January 12, 1979 and effective May 1, 1979.
1.6. Refiling Date. -- This legislative rule were refiled pursuant to W. Va. Code §29A-2-5 of 1931, as amended on the 30th day of December 1982, in the Secretary of State's office.
W. Va. Code R. § 64-23-2 Application, Enforcement
2.1. Application - Except as otherwise specifically provided, this rule applies to all persons in West Virginia who receive, possess, use, transfer, own or acquire any source of ionizing radiation, however, nothing in this rule shall apply, except the provision for registration, to any person to the extent such person is subject to regulation by the United States Nuclear Regulatory Commission. For the purpose of this rule, radiation machines and radioactive materials used by, or in the possession of, an employee within the scope of his duties shall be considered to be in the possession of the employer. The provisions of Section 6. of this rule shall not be interpreted as limiting the intentional exposure of patients to radiation for the purpose of diagnosis or therapy by doctors of the healing arts, duly registered by the State of West Virginia and engaged in the lawful practice of their profession or administered by other professional persons acting under the direct supervision of a registered practitioner.
2.2. Enforcement - The enforcement of this legislative rule is vested with the Director of the West Virginia Department of Health or his lawful designee.
W. Va. Code R. § 64-23-3 Definitions
As used in this rule, these terms have the definitions set forth below. Additional definitions used only in a certain part will be found in that part.
3.1. A1 - the maximum activity of special form radioactive material permitted in a Type A package.
3.2. A2 - the maximum activity of radioactive material, other than special form radioactive material, permitted in a Type A package. These values are either listed in Table 64-23 Ee of this rule, Table 64-23 Ee a, or may be derived in accordance with the procedure prescribed in Table
64-23 Ee of this rule.
3.3. Absorbed Dose - the energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the Gray (Gy) and the Rad.
3.4. Accelerator - any machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and of discharging the resultant particulate or other radiation into a medium at energies usually in excess of one (1) MeV. For purposes of this definition, particle accelerator is an equivalent.
3.5. Accelerator Produced Material - any material made radioactive by exposing it in a particle accelerator.
3.6. Activity - the rate of disintegration or transformation or decay of radioactive material. The units of activity are the Becquerel (Bq) and the Curie (Ci).
3.7. Adult - an individual eighteen (18) or more years of age.
3.8. Agency - the West Virginia division of health.
3.9. Airborne Radioactivity Area - a room, enclosure, or area in which airborne radioactive materials exist in concentrations:
3.9.a. In excess of the derived air concentrations (DACS) specified in Table 64-23 F, Table i of this rule; or
3.9.b. To such a degree that an individual present in the area without respiratory protective equipment could exceed, during the hours an individual is present in a week, an intake of six tenths (0.6) percent of the annual limit on intake (ALI) or twelve (12) DAC hours.
3.10. Airborne Radioactive Material - any airborne radioactive material dispersed in the air in the form of dusts, fumes, mists, vapors or gases.
3.11. As Low As Reasonably Achievable (ALARA) - making every reasonable effort to maintain exposures to radiation as far below the dose limits in this rule as is practical, consistent with the purpose for which the registered activity is undertaken, taking into account the state of technology, the economics of improvements in relation to state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to utilization of nuclear energy and registered sources of radiation in the public interest.
3.12. Background radiation - radiation from cosmic sources; naturally occurring radioactive materials, including radon, except as a decay product of source or special nuclear material, and including global fallout as it exists in the environment from the testing of nuclear explosive devices. Background radiation does not include sources of radiation from radioactive materials regulated by the agency.
3.13. Becquerel (Bq) - the SI unit of activity. One (1) Becquerel is equal to one (1) disintegration or transformation per second (DPS or TPS).
3.14. Bioassay - the determination of kinds, quantities or concentrations, and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body. For purposes of this rule, "radiobioassay" is an equivalent term.
3.15. Brachytherapy - a method of radiation therapy in which sealed sources are utilized to deliver a radiation dose at a distance of up to a few centimeters, by surface, intracavitary, or interstitial application.
3.16. Byproduct Material:
3.16.a. Any radioactive material, except special nuclear material, yielded in or made radioactive by exposure to the radiation incident to the process of producing or utilizing special nuclear material; and
3.16.b. The tailings or wastes produced by the extraction or concentration of uranium or thorium from ore processed primarily for its source material content, including discrete surface wastes resulting from uranium or thorium solution extraction processes. Underground ore bodies depleted by these solution extraction operations do not constitute "byproduct material" within this definition.
3.17. Calibration - the determination of (a) the response or reading of an instrument relative to a series of known radiation values over the range of the instrument, or (b) the strength of a source of radiation relative to a standard.
3.18. Collective Dose - the sum of the individual doses received in a given period of time by a specified population from exposure to a specified source of radiation.
3.19. Committed Dose Equivalent (HT,50) - the dose equivalent to organs or tissues of reference (T) that will be received from an intake of radioactive material by an individual during the fifty- (50) -year period following the intake.
3.20. Committed Effective Dose Equivalent (HE, 50) - the sum of the products of the weighting factors (wT) applicable to each of the body organs or tissues that are irradiated and the committed dose equivalent to each of these organs or tissues (HE,50 = wT HT,50).
3.21. Calendar Quarter - not less that twelve (12) consecutive weeks nor more than fourteen (14) consecutive weeks. The first calendar quarter of each year shall begin in January and subsequent calendar quarters shall be so arranged such that no day is included in more than one calendar quarter and no day in any one year is omitted from inclusion within a calendar quarter. No registrant shall change the method observed by him of determining calendar quarters for the purpose of this rule except at the beginning of the calendar year.
3.22. Curie - a unit of quantity of activity. One (1) Curie (Ci) is that quantity of radioactive material which decays at the rate of 3.7E+10 disintegrations or transformations per second (dps or tps).
3.23. Deep Dose Equivalent (Hd), which applies to external whole body exposure, is the dose equivalent at a tissue depth of one (1) centimeter (one thousand [1000] mg/cm2).
3.24. Depleted Uranium - the source material uranium in which the isotope uranium-235 is less than seven hundred eleven one thousandths (0.711) weight percent of the total uranium present. Depleted uranium does not include special nuclear material.
3.25. Dose - as used in this rule shall mean absorbed dose or dose equivalent as appropriate.
3.25.a. Absorbed Dose - is the energy imparted to matter by ionizing radiation per unit mass of irradiated material at the place of interest. The specific unit of absorbed dose is the rad.
3.25.b. Dose Equivalent - the product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the sievert (Sv) and Rem.
3.26. Dose Limits - the permissible upper bounds of radiation doses established in accordance with this rule. For purposes of this rule, "limits" is an equivalent term.
3.27. Effective Dose Equivalent (HE) - the sum of the products of the dose equivalent to each organ or tissue (HT) and the weighting factor (wT) applicable to each of the body organs or tissues that are irradiated (HE = wTHT).
3.28. Embryo or Fetus - the developing human organism from conception until the time of birth.
3.29. Entrance or Access Point - any opening through which an individual or extremity of an individual could gain access to radiation areas or to registered radioactive materials. This includes entry or exit portals of sufficient size to permit human entry, irrespective of their intended use.
3.30. Explosive Material - any chemical compound, mixture, or device which produces a substantial instantaneous release of gas and heat spontaneously or by contact with sparks or flame.
3.31. Exposure - the quotient of the dQ by dm where "dQ" is the absolute value of the total charge of the ions of one sign produced in air when all the electrons (negatrons and positrons) liberated by photons in a volume element of air having mass "dm" are completely stopped in air. The SI unit of exposure is the Coulomb per kilogram (C/kg). (The special unit of exposure is the Roentgen [R].)
3.32. Exposure Rate - the exposure per unit of time, such as R/min., mR/hr., etc.
3.33. Extremity - hand, elbow, arm below the elbow, foot, knee, and leg below the knee.
3.34. Eye Dose Equivalent - the external dose equivalent to the lens of the eye at a tissue depth of three tenths (0.3) centimeter (three hundred [300] mg/cm2).
3.35. Former Atomic Energy Commission or Nuclear Regulatory Commission Licensed Facilities - nuclear reactors, nuclear fuel reprocessing plants, uranium enrichment plants, or critical mass experimental facilities where Atomic Energy Commission or Nuclear Regulatory commission licenses have been terminated.
3.36. Generally Applicable Environmental Radiation Standards - standards issued by the Environmental Protection Agency under the authority of the Atomic Energy act of 1954, as amended, that impose limits on radiation exposures or levels, or concentrations or quantities of radioactive material, in the general environment outside the boundaries of locations under the control of persons possessing or using radioactive material.
3.37. Gray (Gy) - the SI unit of absorbed dose. One (1) Gray is equal to an absorbed dose of one (1) joule per kilogram (one hundred [100] Rad).
3.38. Half Life - the amount of time required for the activity of a specific radioactive material to reach one-half of its original activity.
3.39. Healing Arts - diagnostic or healing treatment of human and animal maladies including but not limited to the following which are duly registered by the State of West Virginia for the lawful practice of: medicine and its associated specialties, dentistry, veterinary medicine, osteopathy, chiropractic, and podiatry.
3.40. High Radiation Area - any area, accessible to individuals in which radiation levels could result in an individual receiving a dose equivalent in excess of one (1) mSv (one-tenth [0.1] Rem) in one (1) hour at thirty (30) centimeters from any source of radiation or from any surface that the radiation penetrates.
3.41. Human Use - the internal or external administration of radiation or radioactive materials to human beings.
3.42. Individual - any human being.
3.43. Individual Monitoring - the assessment of:
3.43.a. Dose equivalent (a) by the use of individual monitoring devices or (b) by the use of survey data; or
3.43.b. Committed effective dose equivalent (a) by bioassay or (b) by determination of the time-weighted air concentrations to which an individual has been exposed, that is, DAC-hours.
3.44. Individual Monitoring Devices - devices designed to be worn by a single individual for the assessment of dose equivalent. For purposes of this rule, "personnel dosimeter" and "dosimeter" are equivalent terms. Examples of individual monitoring devices are film badges, thermoluminescent dosimeters (TLDS), pocket ionization chambers, and personal air sampling devices.
3.45. Inspection - an official examination or observation including but not limited to tests, surveys, and monitoring to determine compliance with rules, regulations, orders, requirements and conditions of the agency.
3.46. Installation - the location where one or more sources of ionizing radiation are used, operated or stored.
3.47. Instrument Traceability (for ionizing radiation measurements) - the ability to show that an instrument has been calibrated at specified time intervals using a national standard or a transfer standard. If a transfer standard is used, the calibration must be at a laboratory accredited by a program which requires continuing participation in measurement quality assurance with the national institute of standards and technology or other equivalent national or international program.
3.48. Interlock - a device arranged or connected such that the occurrence of an event or condition is required before a second event or condition can occur or continue to occur.
3.49. Internal Dose - that portion of the dose equivalent received from radioactive material taken into the body.
3.50. Licensing State - any state with regulations equivalent to the suggested state regulations for control of radiation relating to, and an effective program for, the regulatory control of narm and which has been granted final designation by the Conference of Radiation Control Program Directors, Inc.
3.51. Limits - the permissible upper bounds of radiation doses established in accordance with this rule.
3.52. Lost or Missing Source of Radiation - registered source of radiation whose location is unknown. This definition includes, but is not limited to, radioactive material that has been shipped but has not reached its planned destination and whose location cannot be readily traced in the transportation system.
3.53. Major Processor - a user processing, handling, or manufacturing radioactive material exceeding Type A quantities as unsealed sources or material, or exceeding four (4) times Type B quantities as sealed sources, but does not include nuclear medicine programs, universities, industrial radiographers, or small industrial programs. Type A and B quantities are defined in Subsection 13.2. of this rule.
3.54. Member of the Public - an individual except when that individual is receiving an occupational dose.
3.55. Monitoring - the measurement of radiation, radioactive material concentrations, surface area activities or quantities of radioactive material and the use of the results of these measurements to evaluate potential exposures and doses. For purposes of this rule, "radiation monitoring" and "radiation protection monitoring" are equivalent terms.
3.56. NARM - any naturally occurring or accelerator-produced radioactive material. It does not include byproduct, source, or special nuclear material.
3.57. Natural Radioactivity - the radioactivity of naturally occurring nuclides.
3.58. Nuclear Regulatory Commission - the Nuclear Regulatory Commission or its duly authorized representatives.
3.59. Occupational Dose - the exposure of an individual to radiation (a) in a restricted area; or (b) in the course of employment in which the individual's duties involve exposure to radiation, provided, that occupational dose shall not be deemed to include any exposure of an individual to radiation for the purpose of diagnosis or therapy of such individual.
3.60. Package - the packaging together with its radioactive contents as presented for transport.
3.61. Particle Accelerator - any machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and of discharging the resultant particulate or other radiation into a medium at energies usually in excess of 1 MeV. For purposes of this definition, particle accelerator is an equivalent.
3.62. Person - any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, agency, political Subdivision of West Virginia, any other state or political Subdivision or agency thereof, and any legal successor, representative, agent or agency of the foregoing, other than the United States Nuclear Regulatory Commission, or any successor thereto, or other federal government agencies.
3.63. Personnel Monitoring Equipment - devices designed to be worn by a single individual for the assessment of dose equivalent. For purposes of this rule, "personnel dosimeter" and "dosimeter" are equivalent terms. Examples of individual monitoring devices are film badges, thermoluminescent dosimeters (TLDS), pocket ionization chambers, and personal air sampling devices.
3.64. Protective Apron - an apron made of radiation-attenuating materials used to reduce exposure to radiation.
3.65. Public Dose - the dose received by a member of the public from sources of radiation from registered operations. Public dose does not include occupational dose, or dose received from background radiation, or dose received as a patient from medical practices, or dose received from voluntary participation in medical research programs.
3.66. Pyrophoric Material - any liquid that ignites spontaneously in dry or moist air at or below 130 F (54.4 C) or any solid material, other than one classed as an explosive, which under normal conditions is liable to cause fires through friction, retained heat from manufacturing or processing, or which can be ignited readily and, when ignited, burns so vigorously and persistently as to create a serious transportation, handling, or disposal hazard. Included are spontaneously combustible and water-reactive materials.
3.67. Qualified Expert - an individual having the knowledge and training to measure ionizing radiation, to evaluate safety techniques, and to advise regarding radiation protection needs, for example, individuals certified in the appropriate field by the American Board of Radiology, or the American Board of Health Physics, or the American Board of Medical Physics, or those having equivalent qualifications. With reference to the calibration of radiation therapy equipment, an individual having, in addition to the above qualifications, training and experience in the clinical applications of radiation physics to radiation therapy, for example, individuals certified in Therapeutic Radiological Physics or X-ray and Radium Physics by the American Board of Radiology, or those having equivalent qualifications.]
3.68. Quality Factor (Q) - the modifying factor, listed in Tables 64-23 A and B, that is used to derive dose equivalent from absorbed dose.
3.69. Rad - the special unit of absorbed dose. One (1) rad is equal to an absorbed dose of one hundred (100) ergs per gram or one-one hundredth (0.01) joule per kilogram (0.01 Gy).
3.70. Radiation - ionizing radiation, i.e., gamma rays and x-rays, alpha and beta particles, high speed electrons, neutrons, and other nuclear particles capable of producing ion pairs. For purposes of this rule, ionizing radiation is an equivalent term. Radiation, as used in this rule, does not include nonionizing radiation, such as microwaves, radiowaves, visible, infrared, or ultraviolet light.
3.71. Radiation Area - any area, accessible to individuals, in which there exists radiation at such levels that a major portion of the body could receive in any one hour a dose in excess of five (5) milliRems, or in any five (5) consecutive days a dose of one hundred (100) milliRems.
3.72. Radiation Machine - any device capable of producing radiation except those which produce radiation only from radioactive material.
3.73. Radiation Safety Officer - one who has the knowledge and responsibility to apply appropriate radiation protection rules.
3.74. Radioactive Material - any material (solid, liquid, or gas) which emits ionizing radiation spontaneously.
3.75. Radioactivity - the disintegration of unstable atomic nuclei by the emission of radiation.
3.76. Radiobioassay - the determination of kinds, quantities or concentrations, and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body.
3.77. Registered Material - radioactive material received, possessed, used, transferred or disposed of under a registration issued by the agency.
3.78. Registrant - any person who is registered with the agency and is legally obligated to register with the agency pursuant to this rule.
3.79. Registration - the filling with the agency by a registrant of all registrable items in accordance with this rule.
3.80. Rem - the special unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem is equal to the absorbed dose in rad multiplied by the quality factor (one [1] Rem = one one-hundredth [0.01] Sv).
3.81. Research and Development - (a) theoretical analysis, exploration, or experimentation; or (b) the extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials, and processes. Research and development does not include the internal or external administration of radiation or radioactive material to human beings.
3.82. Restricted Area (controlled area) - any area access to which is controlled by the registrant for purposes of protection of individuals from exposure to radiation and radioactive material. Restricted areas shall not include any areas used for residential quarters, although a separate room or rooms in a residential building may be set apart as a restricted area.
3.83. Roentgen (R) - the special unit of exposure. One Roentgen equals 2.58 E 104 Coulombs/kilogram of air.
3.84. Sealed Source - radioactive material that is permanently bonded or fixed in a capsule or matrix designed to prevent release and dispersal of the radioactive material under the most severe conditions which are likely to be encountered in normal use and handling.
3.85. Shallow Dose Equivalent (Hs) - which applies to the external exposure of the skin or an extremity, means the dose equivalent at a tissue depth of seven one-thousandth (0.007) centimeter (seven [7] mg/cm2) averaged over an area of one (1) square centimeter.
3.86. SI - the abbreviation for the international system of units.
3.87. Sievert - the SI unit of any of the quantities expressed as dose equivalent. The dose equivalent in Sievert is equal to the absorbed dose in gray multiplied by the quality factor (one [1] Sv = one hundred [100] Rem).
3.88. Source Material - (a) uranium or thorium, or any combination thereof, in any physical or chemical form, or (b) ores which contain by weight one-twentieth (1/20) of one (1) percent (five one-hundredths [0.05] percent) or more of (i) uranium, (ii) thorium, or (iii) any combination thereof. Source material does not include special nuclear material.
3.89. Source Material Milling - any activity that results in the production of byproduct material as defined by definition (b) of byproduct material.
3.90. Source of Radiation - any radioactive material, or any device or equipment emitting or capable of producing radiation.
3.91. Source Traceability - the ability to show that a radioactive source has been calibrated either by the national standards laboratory of the national institute of standards and technology, or by a laboratory which participates in a continuing measurement quality assurance program with national institute of standards and technology or other equivalent national or international program.
3.92. Special Form Radioactive Material - radioactive material that satisfies the following conditions:
3.92.a. It is either a single solid piece or is contained in a sealed capsule that can be opened only by destroying the capsule;
3.92.b. The piece or capsule has at least one dimension not less than five (5) millimeters (two tenths (0.2) inch); and
3.92.c. It satisfies the test requirements specified by the Nuclear Regulatory Commission. A special form encapsulation designed in accordance with the Nuclear Regulatory Commission requirements in effect on June 30, 1983, and constructed prior to July 1, 1985, may continue to be used. A special form encapsulation either designed or constructed after June 30, 1985, must meet requirements of this definition applicable at the time of its design or construction.
3.93. Special Nuclear Materials:
3.93.a. Plutonium, Uranium-233, Uranium enriched in the isotope 233 or in the isotope 235, and any other material that the Nuclear Regulatory Commission, pursuant to the provisions of Section 51 of the atomic energy act of 1954, as amended, determines to be special nuclear material, but does not include source material; or
3.93.b. Any material artificially enriched by any of the foregoing but does not include source material.
3.94. Special Nuclear Material in Quantities not Sufficient to Form a Critical Mass - uranium enriched in the isotope U-235 in quantities not exceeding three hundred fifty (350) grams of contained U-235; Uranium-233 in quantities not exceeding two hundred (200) grams; plutonium in quantities not exceeding two hundred (200) grams; or any combination of them in accordance with the following formula: For each kind of special nuclear material, determine the ratio between the quantity of that special nuclear material and the quantity specified above for the same kind of special nuclear material. The sum of such ratios for all of the kinds of special nuclear material in combination shall not exceed one (1). For example, the following quantities in combination would not exceed the limitation and are within the formula:
3.95. Survey - the evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal, or presence of sources of radiation. When appropriate, such evaluation includes, but is not limited to, tests, physical examinations, and measurements of levels of radiation or concentrations of radioactive material present.
3.96. Test - the process of verifying compliance with an applicable regulation.
3.97. This rule - Sections 1., 2., 3., 4., 5., 6., 7., 8., 9., 10., 11., 12., 13., 14., 15. and 16. of the Radiological Health Rules and any subsequent changes or additions thereto.
3.98. Total Effective Dose Equivalent (TEDE) - the sum of the deep dose equivalent for external exposures and the committed effective dose equivalent for internal exposures.
3.99. Total Organ Dose Equivalent (TODE) - the sum of the deep dose equivalent and the committed dose equivalent to the organ receiving the highest dose as described in Paragraph 6.46.a.6. of this rule.
3.100. Traceable to a National Standard - the ability to show that an instrument or radioactive source has been calibrated by a laboratory which participates in a continuing measurement quality assurance program with National Institute of Standards or other equivalent national or international program.
3.101. Units of Exposure and Dose.
3.101.a. As used in this rule, the unit of exposure is the Coulomb per kilogram (C/kg) of air. One Roentgen is equal to 2.58E-4 Coulomb per kilogram of air.
3.101.b. As used in this rule, the units of dose are:
3.101.b.1. Gray (Gy) is the SI unit of absorbed dose. One Gray is equal to an absorbed dose of one (1) joule per kilogram (one hundred [100] rad).
3.101.b.2. Rad is the special unit of absorbed dose. One Rad is equal to an absorbed dose of one hundred (100) erg per gram or one one-hundredth (0.01) joule per kilogram (one one-hundredth [0.01] Gy).
3.101.b.3. Rem is the special unit of any of the quantities expressed as dose equivalent. The dose equivalent in Rem is equal to the absorbed dose in rad multiplied by the quality factor (one [1] Rem = one one-hundredth [0.01[ Sv).
3.101.b.4. Sievert is the SI unit of any of the quantities expressed as dose equivalent. The dose equivalent in Sievert is equal to the absorbed dose in gray multiplied by the quality factor (one [1] Sv = one hundred [100] Rem).
3.101.c. As used in this rule, the quality factors for converting absorbed dose to dose equivalent are shown in Table 64-23 A.
3.101.d. If it is more convenient to measure the neutron fluence rate than to determine the neutron dose equivalent rate in sievert per hour or rem per hour, as provided in Section 3.102.c., one one-hundredth (0.01) Sv (one [1] Rem) of neutron radiation of unknown energies may, for purposes of this rule, be assumed to result from a total fluence of twenty-five (25) million neutrons per square centimeter incident upon the body. If sufficient information exists to estimate the approximate energy distribution of the neutrons, the registrant may use the fluence rate per unit dose equivalent or the appropriate Q value from Table 64-23 B to convert a measured tissue dose in Gray or Rad to dose equivalent in Sievert or Rem.
3.102. Units of Activity. For purposes of this rule, activity is expressed in the SI unit of Becquerel (Bq) or in the special unit of Curie (Ci), or their multiples, or disintegrations or transformations per unit of time.
3.102.a. One (1) Becquerel (Bq) = one (1) disintegration or transformation per second (DPS or TPS).
3.102.b. One (1) Curie (Ci) = 3.7E+10 disintegrations or transformations per second (DPS or TPS) = 3.7E+10 Becquerel (Bq) = 2.22E+12 disintegrations or transformations per minute (DPM or TPM).
3.103. Unrefined and Unprocessed Ore - ore in its natural form prior to any processing, such as grinding, roasting, beneficiating, or refining.
3.104. Unrestricted Area - any area access to which is not controlled by the registrant for purposes of protection of individuals from exposure to radiation and radioactive material, and any area used for residential quarters.
3.105. Unrefined and Unprocessed Ore - ore in its natural form prior to any processing, such as grinding, roasting, beneficiating, or refining.
3.106. Waste - those low-level radioactive wastes that are acceptable for disposal in a land disposal facility. For the purposes of this definition, low-level waste has the same meaning as in the Low-Level Radioactive Waste Policy Act, P.L. 96-573, as amended by P.L. 99-240, effective January 15, 1986; that is, radioactive waste (a) not classified as high-level radioactive waste, spent nuclear fuel, or byproduct material as defined in Section 11e.(2). of the Atomic Energy Act (uranium or thorium tailings and waste) and (b) classified as low-level radioactive waste consistent with existing law and in accordance with (c) by the Nuclear Regulatory Commission.
3.107. Waste Handling Registrant - persons registered to receive and store radioactive wastes prior to disposal and persons registered to dispose of radioactive waste.
3.108. Week - seven (7) consecutive days starting on Sunday.
3.109. Whole Body - the whole body, for purposes of external exposure, head, trunk including male gonads, arms above the elbow, or legs above the knee.
3.110. Worker - an individual engaged in work under a registration issued by the agency and controlled by a registrant, but does not include the registrant.
3.111. Working Level (WL) - any combination of short-lived radon daughters in one (1) liter of air that will result in the ultimate emission of 1.3E+5 MeV of potential alpha particle energy. The short-lived radon daughters of Radon-222 are Polonium-218, Lead-214, Bismuth-214, and Polonium-214; and those of Radon-220 are Polonium-216, Lead-212, Bismuth-212, and Polonium-212.
3.112. Working Level Month (WLM) - an exposure to one (1) working level for one hundred seventy (170) hours -- two thousand (2,000) working hours per year divided by twelve (12) months per year is approximately equal to one hundred seventy (170) hours per month.
3.113. Year - the period of time beginning in January used to determine compliance with the provisions of this rule. The registrant may change the starting date of the year used to determine compliance by the registrant provided that the change is made at the beginning of the year and that no day is omitted or duplicated in consecutive years.
NOTE: Other terms not herein specifically defined shall be used in accordance with the definitions in the recommendations of the national council on radiation protection and measurements, or any successor thereto, as published in handbooks of the national bureau of standards or reports of the NCRP.
W. Va. Code R. § 64-23-4 Exemptions, Inspections, Tests, Violations, Impounding, Prohibitions and Communications
4.1. Exemptions - The agency may, upon application by any person or upon its own initiative, grant such exemptions or exceptions from the requirements of this rule as it determines are authorized by law and will not result in undue hazard to public health and safety or property.
4.1.a. Department of Energy contractors or subcontractor and Nuclear Regulatory Commission contractors or sub contractors of the following categories operating within this State are exempt from this rule to the extent that such contractor or subcontractor under his contract receives, possesses, uses, transfers, or acquires sources of radiation:
4.1.b. Prime contractors performing work for the department of energy at U.S. government-owned or -controlled sites, including the transportation of sources of radiation to or from such sites and the performance of contract services during temporary interruptions of such transportation;
4.1.c. Prime contractors of the Department of Energy performing research in, or development, manufacture, storage, testing, or transportation of, atomic weapons or components thereof;
4.1.d. Prime contractors of the department of energy using or operating nuclear reactors or other nuclear devices in a United States government-owned vehicle or vessel; and
4.1.e. Any other prime contractor or subcontractor of the Department of Energy or of the Nuclear Regulatory Commission when the State and the Nuclear Regulatory Commission jointly determine:
4.1.e.1. That the exemption of the prime contractor or subcontractor is authorized by law; and
4.1.e.2. That, under the terms of the contract or subcontract, there is adequate assurance that the work thereunder can be accomplished without undue risk to the public health and safety.
4.2. Records. Each registrant shall maintain records showing the receipt, transfer, and disposal of all sources of radiation. Additional record requirements are specified elsewhere in this rule.
4.3. Inspections
4.3.a. Each registrant shall afford the agency, at all reasonable times, opportunity to inspect sources of radiation and the premises and facilities wherein such sources of radiation are used or stored.
4.3.b. Each registrant shall make available to the agency for inspection, upon reasonable notice, records maintained pursuant to this rule.
4.4. Tests - Each registrant shall perform, upon instructions from the agency, or shall permit the agency to perform such reasonable tests as the agency deems appropriate or necessary including, but not limited to, tests of:
4.4.a. Sources of ionizing radiation;
4.4.b. Facilities wherein sources of radiation are used or stored;
4.4.c. Radiation detection and monitoring instruments; and
4.4.d. Other equipment and devices used in connection with utilization or storage of registered sources of radiation.
4.5. Additional Requirements - The agency may, by rule, regulation, or order, impose upon any registrant such requirements in addition to those established in this rule as it deems appropriate or necessary to minimize danger to public health and safety or property.
4.6. Violations - The Director shall, depending upon the severity of the violation and upon the degree of health hazard created, reprimand, or suspend or revoke the registration of any registerable facility, if the registrant:
4.6.a. Fraudulently or deceptively obtains or attempts to obtain a registration;
4.6.b. Fails at any time to comply with the requirements of Chapter 16, Article 1, Section 7. of the West Virginia Code of 1931, as amended;
4.6.c. Fails to comply with fee for service;
4.6.d. Knowingly falsifies or attempts to falsify documents related to registration;
4.6.e. The Director may impose a civil penalty of not less than two hundred fifty dollars ($250) and not more than five thousand ($5000) for each separate violation of this rule payable within thirty (30) days of receipt of the penalty notification.
4.6.f. The Director may, upon the finding of a violation, depending upon the severity of the violation and upon the degree of health hazard created, initiate an appropriate enforcement action which may include the issuance of a cease and desist order directing that all work be halted immediately. Posting the cease and desist order on work site constitutes notice of its contents to the owner and all persons working with radiation producing devices.
4.6.g. In any case where a person fails to halt work following the issuance of a cease and desist order by the Director, the violation is presumed to be willful and the person shall be assessed a civil penalty by the Director of not less than ten thousand dollars ($10,000) nor more than twenty-five thousand dollars ($25,000) for an initial violation and not less than twenty-five thousand ($25,000) nor more than fifty thousand ($50,000) for each subsequent violation payable within thirty (30) days of the receipt of the penalty notification.
4.7. Impounding - In the event that an emergency exists affecting the public health and safety, the agency has the authority to impound or order the impounding of sources of radiation possessed by persons who are not equipped to observe or fail to observe the provisions of this rule.
4.8. Prohibitions
4.8.a. A hand-held fluoroscopic screen shall not be used with x-ray equipment unless it has been listed in the Registry of Sealed Source and Devices or accepted for certification by the Food and Drug Administration, Center for Devices and Radiological Health.
4.8.b. Shoe-fitting fluoroscopic devices shall not be used or displayed.
4.8.c. Operation of a diagnostic x-ray system shall not be permitted without a current diagnostic x-ray certificate issued by the West Virginia Bureau for Public Health.
4.9. Interpretations - Except as specifically authorized by the agency in writing, no interpretation of this rule by an officer or employee of the agency other than a written interpretation by the legal counsel will be recognized to be binding upon the agency.
4.10. Communications - All communications and reports concerning this rule, and applications filed thereunder, should be addressed to the West Virginia Division of Health, Radiological Health Program, 815 Quarrier Street, Charleston, WV 25301.
W. Va. Code R. § 64-23-5 Registration
5.1. Purpose and Scope
5.1.a. This Section provides for the registration of sources of radiation and for the registration of persons providing radiation machine installation, servicing or services. The person having possession of any registrable item shall register such source of radiation with the agency in accordance with the requirements of this Section.
5.1.b. For the purpose of Section 5. of this rule, "facility" is the location at which one or more devices or sources are installed or located within one building, vehicle, or under one roof, and are under the same administrative control.
5.1.c. In addition to the requirements of this Section, all registrants are subject to the applicable provisions of other parts of this rule.
5.1.d. For the purpose of this rule, “storage” is a condition in which a device or source is not being used for an extended period of time, and has been made inoperable.
5.2. Exemptions
5.2.a. The following sources of radiation do not require registration:
5.2.a.1. Less than ten (10) times the quantities of any radioactive material possessed simultaneously, listed in Table 64-23 Y of this rule.
5.2.a.2. Natural radioactive materials of an equivalent specific radioactivity not exceeding that of natural potassium, (one one-hundred millionths [109] Curies/gm).
5.2.a.3. Time pieces, instruments, novelties, or devices containing self-luminous elements, except during manufacture or repair of the self-luminous elements themselves. Such time pieces, instruments, novelties, or devices shall not be exempt if they are stored, used, or handled in such quantity or fashion that an individual might receive a radiation dose exceeding the limits established in Subsection 6.5.
5.2.a.4. Domestic television receivers.
5.2.a.5. Electronic equipment that produces radiation incidental to its operation for other purposes is exempt from the registration and notification requirements of this part, providing dose equivalent rate averaged over an area of ten (10) square centimeters does not exceed five (5) Sv (five-tenths [0.5] mRem) per hour at five (5) cm from any accessible surface of such equipment. The production, testing, or factory servicing of such equipment shall not be exempt.
5.2.a.6. Radiation-producing machines while in transit or storage incident thereto.
5.2.b. Common and contract carriers operating within this state are exempt from registration requirements to the extent that they transport or store sources of radiation in the regular course of their carriage for another or storage incident thereto.
5.3. Application for Registration of Radiation Facilities
5.3.a. The person possessing each registrable item which has not already been registered, shall:
5.3.a.1. Apply for registration of such facility with the agency within thirty (30) days following the effective date of this rule or thereafter prior to the operation of a radiation facility.
5.3.a.2. Make application for registration on forms furnished by the agency and shall supply all the information required by the form and accompanying instructions.
5.3.a.3. Designate on the application form an individual to be responsible for radiation protection.
5.3.a.4. Prohibit any person from furnishing radiation machine servicing or services as described in Subdivision 5.5.d. to his radiation machine facility until such person provides evidence that he has been registered with the agency as a provider of services in accordance with Subsection 5.5.
5.4. Vendor Obligation
5.4.a. Each person who is engaged in the business of installing or offering to install radiation sources or is engaged in the business of furnishing or offering to furnish radiation source servicing or services in this state, shall apply for registration of such services with the agency within thirty (30) days prior to furnishing or offering to furnish any such services.
5.4.b. Any person who sells, leases, transfers, disposes, assembles, installs or lends radiation sources in this state shall notify the agency within fifteen (15) days after the end of each calendar quarter of:
5.4.b.1. The name and address of persons who have received these sources;
5.4.b.2. The manufacturer, model and serial number of each source transferred;
5.4.b.3. The date of transfer of each radiation source.
5.4.c. No person shall make, sell, lease, transfer, lend or install x-ray equipment or radioactive material sources or auxiliaries and supplies necessary for the safe operation of such equipment unless such supplies and equipment, when placed in operation and use, will meet the requirements of this rule.
5.5. Application for Registration of Servicing and Services.
5.5.a. Application for registration shall be completed on forms furnished by the agency and shall contain all information required by the agency as indicated on the forms and accompanying instructions.
5.5.b. Each person applying for registration under this Section shall specify:
5.5.b.1. That he has read and understands the requirements of this and other applicable Sections;
5.5.b.2. The services for which he is applying for registration;
5.5.b.3. The training and experience that qualify him to discharge the services for which he is applying for registration;
5.5.b.4. The type of measurement instruments to be used, frequency of calibration, and source of calibration; and
5.5.b.5. The type of personnel dosimeters supplied, frequency of reading, and replacement or exchange schedule.
5.5.c. For the purpose of Subsection 5.5. services may include but shall not be limited to:
5.5.c.1. Installation or servicing of radiation machines and associated radiation machine components;
5.5.c.2. Calibration of radiation machines or radiation measurement instruments or devices;
5.5.c.3. Radiation protection or health physics consultations or surveys; and
5.5.c.4. Personnel dosimetry services.
5.5.d. No individual shall perform services which are not specifically stated for that individual on the notice of registration issued by the agency.
5.6. Issuance of Notice of Registration.
5.6.a. Upon a determination that an applicant meets the requirements of the rules, the agency shall issue a notice of registration.
5.6.b. The agency may incorporate in the notice of registration at the time of issuance or thereafter by appropriate rule, regulation, or order, such additional requirements and conditions with respect to the registrant's receipt, possession, use, and transfer of radiation producing devices as it deems appropriate or necessary.
5.7. Expiration of Notice of Registration. Except as provided by Subdivision 5.8.a., each notice of registration shall expire at the end of the specified day in the month and year stated therein.
5.8. Renewal of Registration
5.8.a. The person possessing each registrable item shall renew such registration with the agency at a date to be specified by the agency not later than within six (6) months of the effective date of this rule and every three years thereafter.
5.9. Report of Changes
5.9.a. Except as provided in Subdivision 5.9.b. the registrant shall notify the agency in writing within ten (10) days after any change which renders the information on registration no longer accurate. In the case of disposition of radiation sources, such notification shall specify the recipient of these sources.
5.9.b. The registrant is not required to notify the agency of the use of radiation sources at a temporary location other than the designated storage location, provided the initial registration shows that their use at temporary locations is normal to the conduct of the registrant's operations.
5.10. Approval Not Implied
5.10.a. No person, in any advertisement, shall refer to the fact that a source of radiation is registered with the agency, and no person shall state or imply that any activity under such registration has been approved by the agency.
5.11. Reciprocal Recognition of Out-of-State Radiation Producing Devices.
5.11.a. Whenever any radiation producing device is to be brought into the state, for any temporary use, the person proposing to bring such device into the state shall give written notice to the agency at least two (2) working days before such device is to be used in the state. The notice shall include:
5.11.a.1. The type of radiation device;
5.11.a.2. The nature, duration, and scope of use;
5.11.a.3. The exact location or locations where the radiation producing device is to be used; and
5.11.a.4. States in which this device is registered or licensed.
5.11.b. If, for a specific case, the two (2) working-day period would impose an undue hardship on the person, upon application to the agency, permission to proceed sooner may be granted.
5.11.c. The person referred to in subdivision 5.11.a. shall:
5.11.c.1. Comply with all applicable rules of the agency;
5.11.c.2. Supply the agency with such other information as the agency may reasonably request; and
5.11.c.3. Not operate within the state on a temporary basis in excess of one hundred eighty (180) calendar days per year.
5.12. Radiation Protection Requirements
5.12.a. Registrants and persons subject to Subsection 5.11. shall comply with all applicable requirements of this rule, provided, however, that apart from registration, nothing in this rule shall apply to any person to the extent that such person is subject to regulation by the United States Nuclear Regulatory Commission and any legal successor thereof.
W. Va. Code R. § 64-23-6 Standards for Protection Against Radiation
6.1. Purpose and Scope
6.1.a. Except as specifically provided in other Sections of this rule, this Section applies to persons registered by the agency to receive, possess, use, transfer, or dispose of sources of radiation. The limits in this part do not apply to doses due to background radiation, to exposure of patients to radiation for the purpose of medical diagnosis or therapy, or to voluntary participation in medical research programs.
6.1.b. The requirements of this Section are designed to control the receipt, possession, use, transfer, and disposal of sources of radiation by any registrant so the total dose to an individual, including doses resulting from all sources of radiation other than background radiation, does not exceed the standards for protection against radiation prescribed in this Section. However, nothing in this Section shall be construed as limiting actions that may be necessary to protect health and safety in an emergency.
6.2. Definitions - As used in this Section, the following definitions apply:
6.2.a. Annual Limit On Intake (ALI) - the derived limit for the amount of radioactive material taken into the body of an adult worker by inhalation or ingestion in a year. ALI is the smaller value of intake of a given radionuclide in a year by the reference man that would result in a committed effective dose equivalent of five one-hundredths (0.05) Sv (five (5) Rem) or a committed dose equivalent of five- tenths (0.5) Sv (fifty (50) Rem) to any individual organ or tissue. ALI values for intake by ingestion and by inhalation of selected radionuclides are given in Table 64-23 F, Columns 1 and 2.
6.2.b. Class - a classification scheme for inhaled material according to its rate of clearance from the pulmonary region of the lung. Materials are classified as D, W, or Y, which applies to a range of clearance half-times: for Class D, days, of less than ten (10) days, for Class W, weeks, from ten (10) to one hundred (100) days , and for Class Y, years, of greater than one hundred (100) days. For purposes of this rule, "lung class" and "inhalation class" are equivalent terms.
6.2.c. Declared Pregnant Woman - a woman who has voluntarily informed her employer, in writing, of her pregnancy and the estimated date of conception.
6.2.d. Derived Air Concentration (DAC) - the concentration of a given radionuclide in air which, if breathed by the reference man for a working year of two thousand (2,000) hours under conditions of light work, results in an intake of one ALI. For purposes of this rule, the condition of light work is an inhalation rate of one and two-tenths (1.2) cubic meters of air per hour for two thousand (2,000) hours in a year. DAC values are given in Table 64-23 F, Table I, Column 3.
6.2.e. Derived Air Concentration-hour (DAC-hour) - the product of the concentration of radioactive material in air, expressed as a fraction or multiple of the derived air concentration for each radionuclide, and the time of exposure to that radionuclide, in hours. A registrant may take two thousand (2,000) DAC-hours to represent one ALI, equivalent to a committed effective dose equivalent of five one-hundredths (0.05) Sv (five [5] Rem).
6.2.f. Dosimetry Processor - an individual or an organization that processes and evaluates individual monitoring devices in order to determine the radiation dose delivered to the monitoring devices.
6.2.g. Inhalation Class - a classification scheme for inhaled material according to its rate of clearance from the pulmonary region of the lung. Materials are classified as D, W, or Y, which applies to a range of clearance half-times: for Class D, days, of less than ten (10) days, for Class W, weeks, from ten (10) to one hundred (100) days , and for Class Y, years, of greater than one hundred (100) days.
6.2.h. Lung Class - a classification scheme for inhaled material according to its rate of clearance from the pulmonary region of the lung. Materials are classified as D, W, or Y, which applies to a range of clearance half-times: for Class D, days, of less than ten (10) days, for Class W, weeks, from ten (10) to one hundred (100) days , and for Class Y, years, of greater than one hundred (100) days.
6.2.i. Nonstochastic Effect - a health effect, the severity of which varies with the dose and for which a threshold is believed to exist. Radiation-induced cataract formation is an example of a nonstochastic effect. For purposes of this rule, "deterministic effect" is an equivalent term.
6.2.j. Planned Special Exposure - an infrequent exposure to radiation, separate from and in addition to the annual occupational dose limits.
6.2.k. Quarter - a period of time equal to one-fourth of the year observed by the registrant, approximately thirteen (13) consecutive weeks, providing that the beginning of the first quarter in a year coincides with the starting date of the year and that no day is omitted or duplicated in consecutive quarters.
6.2.l. Reference Man - a hypothetical aggregation of human physical and physiological characteristics determined by international consensus. These characteristics may be used by researchers and public health employees to standardize results of experiments and to relate biological insult to a common base. A description of the reference man is contained in the International Commission on Radiological Protection Report, ICRP publication 23, "Report of the Task Group on Reference Man."
6.2.m. Respiratory Protective Equipment - an apparatus, such as a respirator, used to reduce an individual's intake of airborne radioactive materials.
6.2.n. Sanitary Sewerage - a system of public sewers for carrying off waste water and refuse, but excluding sewage treatment facilities, septic tanks, and leach fields owned or operated by the registrant.
6.2.o. Stochastic Effect - a health effect that occurs randomly and for which the probability of the effect occurring, rather than its severity, is assumed to be a linear function of dose without threshold. Hereditary effects and cancer incidence are examples of stochastic effects. For purposes of this rule, "probabilistic effect" is an equivalent term.
6.2.p. Very High Radiation Area - an area, accessible to individuals, in which radiation levels could result in an individual receiving an absorbed dose in excess of five (5) Gy (five hundred [500] Rad) in one (1) hour at one (1) meter from a source of radiation or from any surface that the radiation penetrates.1
6.2.q. Weighting Factor wT for An Organ or Tissue (T) - the proportion of the risk of stochastic effects resulting from irradiation of that organ or tissue to the total risk of stochastic effects when the whole body is irradiated uniformly. For calculating the effective dose equivalent, the values of wT are listed in Table 64-23 C.
6.3. Implementation
6.3.a. Any existing registration condition that is more restrictive than Section 6. remains in force until there is an amendment or renewal of the registration.
6.3.b. If a registration condition exempts a registrant from a provision of Section 6. in effect on or before July 1, 2001, it also exempts the registrant from the corresponding provision of Section 6.
6.3.c. If a registration condition cites provisions of Section 6. in effect prior to July 1, 2001, which do not correspond to any provisions of Section 6., the registration condition remains in force until there is an amendment or renewal of the registration that modifies or removes this condition.
6.4. Radiation Protection Programs.
6.4.a. Each registrant shall develop, document, and implement a radiation protection program sufficient to ensure compliance with the provisions of Section 6. See Subsection 6.41. for record keeping requirements relating to these programs.
6.4.b. The registrant shall use, to the extent practicable, procedures and engineering controls based upon sound radiation protection principles to achieve occupational doses and public doses that are as low as is reasonably achievable (ALARA).
6.4.c. The registrant shall, at intervals not to exceed twelve (12) months, review the radiation protection program content and implementation.
6.5. Occupational Dose Limits for Adults.
6.5.a. The registrant shall control the occupational dose to individual adults, except for planned special exposures pursuant to Subsection 6.10. to the following dose limits:
6.5.a.1. An annual limit, which is the more limiting of:
6.5.a.1.A. The total effective dose equivalent being equal to five one-hundredths (0.05) Sv (five [5] Rem); or
6.5.a.1.B. The sum of the deep dose equivalent and the committed dose equivalent to any individual organ or tissue other than the lens of the eye being equal to five-tenths (0.5) Sv (fifty [50] Rem).
6.5.a.2. The annual limits to the lens of the eye, to the skin, and to the extremities which are listed in Table 64-23 D.
6.5.a.2.A. An eye dose equivalent of fifteen one hundredths .15 Sv; and
6.5.a.2.B. A shallow dose equivalent of five-tenths (0.5) Sv (fifty [50] Rem) to the skin or to any extremity.
6.5.b. Doses received in excess of the annual limits, including doses received during accidents, emergencies, and planned special exposures, shall be subtracted from the limits for planned special exposures that the individual may receive during the current year and during the individual's lifetime. See Paragraphs 6.10.f.1. and 2.
6.5.c. The assigned deep dose equivalent and shallow dose equivalent shall be for the portion of the body receiving the highest exposure:
6.5.c.1. The deep dose equivalent, eye dose equivalent and shallow dose equivalent may be assessed from surveys or other radiation measurements for the purpose of demonstrating compliance with the occupational dose limits, if the individual monitoring device was not in the region of highest potential exposure, or the results of individual monitoring are unavailable; or
6.5.c.2. When a protective apron is worn while working with medical fluoroscopic equipment and monitoring is conducted as specified in Section 6.17.a.5., the effective dose equivalent for external radiation shall be determined as follows:
6.5.c.2.A. When only one individual monitoring device is used and it is located at the neck outside the protective apron, the reported deep dose equivalent shall be the effective dose equivalent for external radiation; or
6.5.c.2.B. When only one individual monitoring device is used and it is located at the neck outside the protective apron, and the reported dose exceeds twenty-five (25) percent of the limit specified in Subdivision 6.5.a., the reported deep dose equivalent value multiplied by three-tenths (0.3) shall be the effective dose equivalent for external radiation; or
6.5.c.2.C. When individual monitoring devices are worn, both under the protective apron at the waist and outside the protective apron at the neck, the effective dose equivalent for external radiation shall be assigned the value of the sum of the deep dose equivalent reported for the individual monitoring device located at the waist under the protective apron multiplied by one and five-tenths (1.5) and the deep dose equivalent reported for the individual monitoring device located at the neck outside the protective apron multiplied by four one-hundredths (0.04).
6.5.d. Derived air concentration (DAC) and annual limit on intake (ALI) values are specified in Table 64-23 F Table I and may be used to determine the individual's dose and to demonstrate compliance with the occupational dose limits. See Subsection 6.46.
6.5.e. Notwithstanding the annual dose limits, the or registrant shall limit the soluble uranium intake by an individual to ten (10) milligrams in a week in consideration of chemical toxicity (footnote c of Table 64-23 F).
6.5.f. The registrant shall reduce the dose that an individual may be allowed to receive in the current year by the amount of occupational dose received while employed by any other person during the current year (Subsection 6.9).
6.6. Compliance with Requirements for Summation of External and Internal Doses.
6.6.a. If the registrant is required to monitor pursuant to both Subdivisions 6.17.a. and b., the registrant shall demonstrate compliance with the dose limits by summing external and internal doses. If the registrant is required to monitor only pursuant to Subdivision 6.17.a. or only pursuant to Subdivision 6.17.b., then summation is not required to demonstrate compliance with the dose limits. The registrant may demonstrate compliance with the requirements for summation of external and internal doses pursuant to Subdivisions 6.6.b., c. and d. The dose equivalents for the lens of the eye, the skin, and the extremities are not included in the summation, but are subject to separate limits.
6.6.b. Intake by Inhalation. If the only intake of radionuclides is by inhalation, the total effective dose equivalent limit is not exceeded if the sum of the deep dose equivalent divided by the total effective dose equivalent limit, and one of the following, does not exceed unity:
6.6.b.1. The sum of the fractions of the inhalation ALI or each radionuclide; or
6.6.b.2. The total number of derived air concentration-hours (DAC-hours) for all radionuclides divided by two thousand (2,000); or
6.6.b.3. The sum of the calculated committed effective dose equivalents to all significantly irradiated organs or tissues (T) calculated from bioassay data using appropriate biological models and expressed as a fraction of the annual limit. For purposes of this requirement, an organ or tissue is deemed to be significantly irradiated if, for that organ or tissue, the product of the weighting factors, wT, and the committed dose equivalent, HT,50, per unit intake is greater than ten (10) percent of the maximum weighted value of HT,50, that is, wTHT,50, per unit intake for any organ or tissue.
6.6.c. Intake by Oral Ingestion. If the occupationally exposed individual receives an intake of radionuclides by oral ingestion greater than ten (10) percent of the applicable oral ALI, the registrant shall account for this intake and include it in demonstrating compliance with the limits.
6.6.d. Intake through Wounds or Absorption through Skin. The registrant shall evaluate and, to the extent practical, account for intakes through wounds or skin absorption. The intake through intact skin has been included in the calculation of DAC for Hydrogen-3 and does not need to be evaluated or accounted for pursuant to Subsection 6.6.d.
6.6.e. Orders Requiring Furnishing of Bioassay Services - Where necessary or desirable in order to aid in determining the extent of an individual's exposure to concentrations of radioactive material, the agency may incorporate registration provisions or issue an order requiring a registrant to make available to the individual appropriate bioassay services and to furnish a copy of the reports of such services to the agency.
6.7. Determination of External Dose from Airborne Radioactive Material.
6.7.a. Registrants shall, when determining the dose from airborne radioactive material, include the contribution to the deep dose equivalent, eye dose equivalent, and shallow dose equivalent from external exposure to the radioactive cloud. See Table 64-23-F, footnotes a and b.
6.7.b. Airborne radioactivity measurements and DAC values shall not be used as the primary means to assess the deep dose equivalent when the airborne radioactive material includes radionuclides other than noble gases or if the cloud of airborne radioactive material is not relatively uniform. The determination of the deep dose equivalent to an individual shall be based upon measurements using instruments or individual monitoring devices.
6.8. Determination of Internal Exposure.
6.8.a. For purposes of assessing dose used to determine compliance with occupational dose equivalent limits, the registrant shall, when required pursuant to Subsection 6.17., take suitable and timely measurements of:
6.8.a.1. Concentrations of radioactive materials in air in work areas; or
6.8.a.2. Quantities of radionuclides in the body; or
6.8.a.3. Quantities of radionuclides excreted from the body; or
6.8.a.4. Combinations of these measurements.
6.8.b. Unless respiratory protective equipment is used, as provided in Section 6.24., or the assessment of intake is based on bioassays, the registrant shall assume that an individual inhales radioactive material at the airborne concentration in which the individual is present.
6.8.c. When specific information on the physical and biochemical properties of the radionuclides taken into the body or the behavior of the material in an individual is known, the registrant may:
6.8.c.1. Use that information to calculate the committed effective dose equivalent, and, if used, the registrant shall document that information in the individual's record; and
6.8.c.2. Upon prior approval of the agency, adjust the DAC or ALI values to reflect the actual physical and chemical characteristics of airborne radioactive material, for example, aerosol size distribution or density; and
6.8.c.3. Separately assess the contribution of fractional intakes of Class D, W, or Y compounds of a given radionuclide to the committed effective dose equivalent. See Table 64-23 F.
6.8.d. If the registrant chooses to assess intakes of class y material using the measurements given in Paragraph 6.8.a.2. or 3., the registrant may delay the recording and reporting of the assessments for periods up to seven (7) months, unless otherwise required by Subsections 6.42. or 6.43. This delay permits the registrant to make additional measurements basic to the assessments.
6.8.e. If the identity and concentration of each radionuclide in a mixture are known, the fraction of the DAC applicable to the mixture for use in calculating DAC-hours shall be either:
6.8.e.1. The sum of the ratios of the concentration to the appropriate DAC value, that is, D, W, or Y, from Table 64-23 F for each radionuclide in the mixture; or
6.8.e.2. The ratio of the total concentration for all radionuclides in the mixture to the most restrictive DAC value for any radionuclide in the mixture.
6.8.f. If the identity of each radionuclide in a mixture is known, but the concentration of one or more of the radionuclides in the mixture is not known, the DAC for the mixture shall be the most restrictive DAC of any radionuclide in the mixture.
6.8.g. When a mixture of radionuclides in air exists, a registrant may disregard certain radionuclides in the mixture if:
6.8.g.1. The registrant uses the total activity of the mixture in demonstrating compliance with the dose limits in Subsection 6.5. and in complying with the monitoring requirements in Paragraph 6.17.b.; and
6.8.g.2. The concentration of any radionuclide disregarded is less than ten (10) percent of its DAC; and
6.8.g.3. The sum of these percentages for all of the radionuclides disregarded in the mixture does not exceed thirty (30) percent.
6.8.h. When determining the committed effective dose equivalent, the following information may be considered:
6.8.h.1. In order to calculate the committed effective dose equivalent, the registrant may assume that the inhalation of one ALI, or an exposure of two thousand (2,000) DAC-hours, results in a committed effective dose equivalent of five one-hundredths (0.05) Sv (five [5] Rem) for radionuclides that have their ALIs or DACS based on the committed effective dose equivalent;
6.8.h.2. For an ALI and the associated DAC determined by the nonstochastic organ dose limit of five tenths (0.5) Sv (fifty [50] Rem), the intake of radionuclides that would result in a committed effective dose equivalent of five one-hundredths (0.05) Sv (five [5] Rem), that is, the stochastic ALI, is listed in parentheses in Table I of Table 64-23 F. The registrant may, as a simplifying assumption, use the stochastic ALI to determine committed effective dose equivalent. However, if the registrant uses the stochastic ALI, the registrant shall also demonstrate that the limit in Subparagraph 6.5.a.1.B. is met.
6.9. Determination of Prior Occupational Dose.
6.9.a. For each individual who may enter the registrant's restricted area and is likely to receive, in a year, an occupational dose requiring monitoring pursuant to Subsection 6.17. the registrant shall:
6.9.a.1. Determine the occupational radiation dose received during the current year; and
6.9.a.2. Attempt to obtain the records of lifetime cumulative occupational radiation dose.
6.9.b. Prior to permitting an individual to participate in a planned special exposure, the registrant shall determine:
6.9.b.1. The internal and external doses from all previous planned special exposures; and
6.9.b.2. All doses in excess of the limits, including doses received during accidents and emergencies, received during the lifetime of the individual.
6.9.c. In complying with the requirements of Subdivision 6.9.a., a registrant may:
6.9.c.1. Accept, as a record of the occupational dose that the individual received during the current year, a written signed statement from the individual, or from the individual's most recent employer for work involving radiation exposure, that discloses the nature and the amount of any occupational dose that the individual received during the current year; and
6.9.c.2. Accept, as the record of lifetime cumulative radiation dose, an up-to-date Agency Form Y or equivalent, signed by the individual and countersigned by an appropriate official of the most recent employer for work involving radiation exposure, or the individual's current employer, if the individual is not employed by the registrant; and
6.9.c.3. Obtain reports of the individual's dose equivalent from the most recent employer for work involving radiation exposure, or the individual's current employer, if the individual is not employed by the registrant, by telephone, telegram, facsimile, or letter. The registrant shall request a written verification of the dose data if the authenticity of the transmitted report cannot be established.
6.9.d. The registrant shall record the exposure history, as required by Subdivision 6.9.a., on Agency Form Y, or other clear and legible record, of all the information required on that form. The form or record shall show each period in which the individual received occupational exposure to radiation or radioactive material and shall be signed by the individual who received the exposure. For each period for which the registrant obtains reports, the registrant shall use the dose shown in the report in preparing Agency Form Y or equivalent. For any period in which the registrant does not obtain a report, the registrant shall place a notation on Agency Form Y or equivalent indicating the periods of time for which data are not available.
6.9.e. Registrants are not required to partition historical dose between external dose equivalent and internal committed dose equivalent. Further, occupational exposure histories obtained and recorded on Agency Form Y or equivalent before July 1, 2001, might not have included effective dose equivalent, but may be used in the absence of specific information on the intake of radionuclides by the individual.
6.9.f. If the registrant is unable to obtain a complete record of an individual's current and previously accumulated occupational dose, the registrant shall assume:
6.9.f.1. In establishing administrative controls pursuant to Subdivision 6.5.f. for the current year, that the allowable dose limit for the individual is reduced by twelve and five tenths (12.5) mSv (one and twenty five one-hundredths [1.25] Rem) for each quarter for which records were unavailable and the individual was engaged in activities that could have resulted in occupational radiation exposure; and
6.9.f.2. That the individual is not available for planned special exposures.
6.9.g. The registrant shall retain the records on Agency Form Y or equivalent until the agency terminates each pertinent registration requiring this record. The registrant shall retain records used in preparing Agency Form Y or equivalent for three (3) years after the record is made.
6.10. Planned Special Exposures.
6.10.a. A registrant may authorize an adult worker to receive doses in addition to and accounted for separately from the doses received under the limits specified in Subsection 6.5. provided that each of the following conditions is satisfied:
6.10.b. The registrant authorizes a planned special exposure only in an exceptional situation when alternatives that might avoid the higher exposure are unavailable or impractical;
6.10.c. The registrant, and employer if the employer is not the registrant, specifically authorizes the planned special exposure, in writing, before the exposure occurs;
6.10.d. Before a planned special exposure, the registrant ensures that each individual involved is:
6.10.d.1. Informed of the purpose of the planned operation; and
6.10.d.2. Informed of the estimated doses and associated potential risks and specific radiation levels or other conditions that might be involved in performing the task; and
6.10.d.3. Instructed in the measures to be taken to keep the dose ALARA considering other risks that may be present;
6.10.e. Prior to permitting an individual to participate in a planned special exposure, the registrant ascertains prior doses as required by subdivision 6.9.b. during the lifetime of the individual for each individual involved;
6.10.f. Subject to Subdivision 6.5.b., the registrant shall not authorize a planned special exposure that would cause an individual to receive a dose from all planned special exposures and all doses in excess of the limits to exceed:
6.10.f.1. The numerical values of any of the dose limits in Subdivision 6.5.a. in any year; and
6.10.f.2. Five (5) times the annual dose limits in Subdivision 6.5.a. during the individual's lifetime;
6.10.g. The registrant maintains records of the conduct of a planned special exposure in accordance with Subsection 6.45. and submits a written report in accordance with Subsection 6.55.;
6.10.h. The registrant records the best estimate of the dose resulting from the planned special exposure in the individual's record and informs the individual, in writing, of the dose within thirty (30) days from the date of the planned special exposure. The dose from planned special exposures shall not be considered in controlling future occupational dose of the individual pursuant to Subdivision 6.5.a. but shall be included in evaluations required by Subdivisions 6.10.d. and e.
6.11. Occupational Dose Limits for Minors. The annual occupational dose limits for minors are ten (10) percent of the annual occupational dose limits specified for adult workers in Subsection 6.5.
6.12. Dose to an Embryo or Fetus.
6.12.a. The registrant shall ensure that the dose to an embryo or fetus during the entire pregnancy, due to occupational exposure of a declared pregnant woman, does not exceed five (5) mSv [five-tenths (0.5 Rem)]. See Subsection 6.46. for record keeping requirements.
6.12.b. The registrant shall make efforts to avoid substantial variation 2above a uniform monthly exposure rate to a declared pregnant woman so as to satisfy the limit in Subdivision 6.12.a.
6.12.c. The dose to an embryo or fetus shall be taken as the sum of:
6.12.c.1. The dose to the embryo or fetus from radionuclides in the embryo or fetus and radionuclides in the declared pregnant woman; and
6.12.c.2. The dose that is most representative of the dose to the embryo or fetus from external radiation, that is, in the mother's lower torso region.
6.12.c.2.A. If multiple measurements have not been made, assignment of the highest deep dose equivalent for the declared pregnant woman shall be the dose to the embryo or fetus, in accordance with Subdivision 6.9.c.; or
6.12.c.2.B. If multiple measurements have been made, assignment of the deep dose equivalent for the declared pregnant woman from the individual monitoring device which is most representative of the dose to the embryo or fetus shall be the dose to the embryo or fetus. Assignment of the highest deep dose equivalent for the declared pregnant woman to the embryo or fetus is not required unless that dose is also the most representative deep dose equivalent for the region of the embryo or fetus.
6.12.d. If by the time the woman declares pregnancy to the registrant, the dose to the embryo or fetus has exceeded four and five-tenths (4.5) mSv (forty-five one-hundredths [0.45 Rem]), the or registrant shall be deemed to be in compliance with Section 6.12.a. if the additional dose to the embryo or fetus does not exceed five-tenths (0.5) mSv (five one-hundredths [0.05] Rem) during the remainder of the pregnancy.
6.13. Dose Limits for Individual Members of the Public.
6.13.a. Each registrant shall conduct operations so that:
6.13.a.1. Except as provided in item 6.13.a.3., the total effective dose equivalent to individual members of the public from the registered operation does not exceed one (1) mSv (one-tenth [0.1] Rem) in a year, exclusive of the dose contribution from the registrant's disposal of radioactive material into sanitary sewerage in accordance with Subsection 6.35.; and
6.13.a.2. The dose in any unrestricted area from external sources does not exceed two one-hundredths (0.02) mSv (two one-thousandths [0.002] Rem) in any one hour; and
6.13.a.3. The total effective dose equivalent to individual members of the public from infrequent exposure to radiation from radiation machines does not exceed five (5) mSv (five-tenths [0.5] Rem).
6.13.b. If the registrant permits members of the public to have access to restricted areas, the limits for members of the public continue to apply to those individuals.
6.13.c. A registrant or an applicant for registration may apply for prior agency authorization to operate up to an annual dose limit for an individual member of the public of five (5) mSv (five-tenths [0.5] Rem). This application shall include the following information:
6.13.c.1. Demonstration of the need for and the expected duration of operations in excess of the limit in 6.13.a.; and
6.13.c.2. The registrant's program to assess and control dose within the five (5) mSv (five-tenths [0.5] Rem) annual limit; and
6.13.c.3. The procedures to be followed to maintain the dose ALARA.
6.13.d. In addition to the requirements of Section 6., a registrant subject to the provisions of the United States Environmental Protection Agency's generally applicable Environmental Radiation Standards in 40 CFR 190 shall comply with those standards.
6.13.e. The agency may impose additional restrictions on radiation levels in unrestricted areas and on the total quantity of radionuclides that a registrant may release in effluents in order to restrict the collective dose.
6.14. Compliance with Dose Limits for Individual Members of the Public.
6.14.a. The registrant shall make or cause to be made surveys of radiation levels in unrestricted areas and radioactive materials in effluents released to unrestricted areas to demonstrate compliance with the dose limits for individual members of the public in Subsection 6.13.
6.14.b. A registrant shall show compliance with the annual dose limit in Subsection 6.13. by:
6.14.b.1. Demonstrating by measurement or calculation that the total effective dose equivalent to the individual likely to receive the highest dose from the registered operation does not exceed the annual dose limit; or
6.14.b.2. Demonstrating that:
6.14.b.2.A. The annual average concentrations of radioactive material released in gaseous and liquid effluents at the boundary of the unrestricted area do not exceed the values specified in Table II of Table 64-23 F; and
6.14.b.2.B. If an individual were continuously present in an unrestricted area, the dose from external sources would not exceed two one-hundredths (0.02) mSv (two one-thousandths [0.002] Rem) in an hour and five-tenths (0.5) mSv (five one-hundredths [0.05] Rem) in a year.
6.14.c. Upon approval from the agency, the registrant may adjust the effluent concentration values in Table 64-23 F, or members of the public, to take into account the actual physical and chemical characteristics of the effluents, such as aerosol size distribution, solubility, density, radioactive decay equilibrium, and chemical form.
6.15. Testing for Leakage or Contamination of Sealed Sources.
6.15.a. The registrant in possession of any sealed source shall assure that:
6.15.a.1. Each sealed source, except as specified in Subdivision 6.15.b., is tested for leakage or contamination and the test results are received before the sealed source is put into use unless the registrant has a certificate from the transferor indicating that the sealed source was tested within six (6) months before transfer to the registrant monitoring device used for monitoring the dose to the whole body shall be worn at the unshielded location of the whole body likely to receive the highest exposure. When a protective apron is worn, the location of the individual monitoring device is typically at the neck (collar);
6.15.a.2. Each sealed source that is not designed to emit alpha particles is tested for leakage or contamination at intervals not to exceed 6 months or at alternative intervals approved by the agency, after evaluation of information specified by of this rule, an agreement state, a licensing state, or the Nuclear Regulatory Commission;
6.15.a.3. Each sealed source that is designed to emit alpha particles is tested for leakage or contamination at intervals not to exceed 3 months or at alternative intervals approved by the agency, after evaluation of information specified by this rule, an agreement state, a licensing state, or the Nuclear Regulatory Commission;
6.15.a.4. For each sealed source that is required to be tested for leakage or contamination, at any other time there is reason to suspect that the sealed source might have been damaged or might be leaking, the registrant shall assure that the sealed source is tested for leakage or contamination before further use;
6.15.a.5. Tests for leakage for all sealed sources, except brachytherapy sources manufactured to contain radium, shall be capable of detecting the presence of one hundred eighty-five (185) Bq (five one-thousandths [0.005] Ci) of radioactive material on a test sample. Test samples shall be taken from the sealed source or from the surfaces of the container in which the sealed source is stored or mounted on which one might expect contamination to accumulate. For a sealed source contained in a device, test samples are obtained when the source is in the "off" position;
6.15.a.6. The test for leakage for brachytherapy sources manufactured to contain radium shall be capable of detecting an absolute leakage rate of thirty-seven (37) Bq (one one-thousandths [0.001] Ci) of Radon-222 in a twenty-four 24 hour period when the collection efficiency for Radon-222 and its daughters has been determined with respect to collection method, volume and time;
6.15.a.7. Tests for contamination from radium daughters shall be taken on the interior surface of brachytherapy source storage containers and shall be capable of detecting the presence of one hundred eighty-five (185) Bq (five one-thousandths [0.005] Ci) of a radium daughter which has a half-life greater than four (4) days.
6.15.b. A registrant need not perform test for leakage or contamination on the following sealed sources:
6.15.b.1. Sealed sources containing only radioactive material with a half-life of less than thirty (30) days;
6.15.b.2. Sealed sources containing only radioactive material as a gas;
6.15.b.3. Sealed sources containing three and seven-tenth (3.7) MBq (one hundred [100] Ci) or less of beta or photon-emitting material or three hundred seventy (370) kBq (ten [10] Ci) or less of alpha-emitting material;
6.15.b.4. Sealed sources containing only hydrogen-3;
6.15.b.5. Seeds of Iridium-192 encased in nylon ribbon; and
6.15.b.6. Sealed sources, except teletherapy and brachytherapy sources, which are stored, not being used and identified as in storage. The registrant shall, however, test each such sealed source for leakage or contamination and receive the test results before any use or transfer unless it has been tested for leakage or contamination within six (6) months before the date of use or transfer.
6.15.c. Tests for leakage or contamination from sealed sources shall be performed by persons specifically authorized by the agency, an agreement state, a licensing state, or the Nuclear Regulatory Commission to perform such services.
6.15.d. Test results shall be kept in units of becquerel or microcurie and maintained for inspection by the agency. Records of test results for sealed sources shall be made pursuant to Subsection 6.43.
6.15.e. The following shall be considered evidence that a sealed source is leaking:
6.15.e.1. The presence of one hundred eighty-five (185) Bq (five one-thousandths [0.005] Ci) or more of removable contamination on any test sample;
6.15.e.2. Leakage of thirty-seven (37) Bq (one one-thousandth [0.001] Ci) of Radon-222 per twenty four (24) hours for brachytherapy sources manufactured to contain radium;
6.15.e.3. The presence of removable contamination resulting from the decay of one hundred eighty-five (185) Bq (five one-thousandths [0.005] Ci) or more of radium.
6.15.f. The registrant shall immediately withdraw a leaking sealed source from use and shall take action to prevent the spread of contamination. The leaking sealed source shall be repaired or disposed of in accordance with this Section.
6.15.g. Reports of test results for leaking or contaminated sealed sources shall be made pursuant to Subsection 6.58.
6.16. Surveys and Monitoring
6.16.a. Each registrant shall make, or cause to be made, surveys that:
6.16.a.1. Are necessary for the registrant to comply with Section 6.; and
6.16.a.2. Are necessary under the circumstances to evaluate:
6.16.a.2.A. Radiation levels; and
6.16.a.2.B. Concentrations or quantities of radioactive material; and
6.16.a.2.C. The potential radiological hazards that could be present.
6.16.b. The registrant shall ensure that instruments and equipment used for quantitative radiation measurements, for example, dose rate and effluent monitoring, are calibrated at intervals not to exceed twelve (12) months for the radiation measured, except when a more frequent interval is specified in another applicable Section of this rule.
6.16.c. All personnel dosimeters, except for direct and indirect reading pocket ionization chambers and those dosimeters used to measure the dose to any extremity, that require processing to determine the radiation dose and that are used by registrants to comply with Subsection 6.5., with other applicable provisions of this rule, or with conditions specified in a registration shall be processed and evaluated by a dosimetry processor:
6.16.c.1. Holding current personnel dosimetry accreditation from the national voluntary laboratory accreditation program of the national institute of standards and technology; and
6.16.c.2. Approved in this accreditation process for the type of radiation or radiations included in the national voluntary laboratory accreditation program that most closely approximates the type of radiation or radiations for which the individual wearing the dosimeter is monitored.
6.16.d. The registrant shall ensure that adequate precautions are taken to prevent a deceptive exposure of an individual monitoring device.
6.17. Conditions Requiring Individual Monitoring of External and Internal Occupational Dose.
6.17.a. Each registrant shall monitor exposures from sources of radiation at levels sufficient to demonstrate compliance with the occupational dose limits of Section 6. As a minimum:
6.17.a.1. Each registrant shall monitor occupational exposure to radiation and shall supply and require the use of individual monitoring devices by:
6.17.a.2. Adults likely to receive, in 1 year from sources external to the body, a dose in excess of 10 percent of the limits in Subdivision 6.5.a.;
6.17.a.3. Minors and declared pregnant women likely to receive, in 1 year from sources external to the body, a dose in excess of ten (10) percent of any of the applicable limits in Subsection 6.11. or Subsection 6.12.;
6.17.a.4. Individuals entering a high or very high radiation area; and
6.17.a.5. Individuals working with medical fluoroscopic equipment;
6.17.a.5.A. An individual monitoring device used for the dose to an embryo or fetus of a declared pregnant woman, pursuant to Subdivision 6.12.a., shall be located under the protective apron at the waist;
6.17.a.5.B. An individual monitoring device used for eye dose equivalent shall be located at the neck, or an unshielded location closer to the eye, outside the protective apron; and
6.17.a.5.C. When only 1 individual monitoring device is used to determine the effective dose equivalent for external radiation pursuant to Paragraph 6.5.c.2., it shall be located at the neck outside the protective apron. When a second individual monitoring device is used, for the same purpose, it shall be located under the protective apron at the waist. The second individual monitoring device is required for a declared pregnant woman.
6.17.b. Each registrant shall monitor, to determine compliance with Subsection 6.8., the occupational intake of radioactive material by and assess the committed effective dose equivalent to:
6.17.b.1. Adults likely to receive, in one (1) year, an intake in excess of ten (10) percent of the applicable ALI in Table I, Columns 1 and 2, of Table 64-23 F; and
6.17.b.2. Minors and declared pregnant women likely to receive, in one(1) year, a committed effective dose equivalent in excess of five tenths (0.5) mSv (five one-hundredths [0.05] Rem).
6.18. Location of Individual Monitoring Devices.
6.18.a. Each registrant shall ensure that individuals who are required to monitor occupational doses in accordance with Subdivision 6.17.a. wear individual monitoring devices as follows:
6.18.a.1. An individual monitoring device used for monitoring the dose to the whole body shall be worn at the unshielded location of the whole body likely to receive the highest exposure. When a protective apron is worn, the location of the individual monitoring device is typically at the neck (collar);
6.18.a.2. An individual monitoring device used for monitoring the dose to an embryo or fetus of a declared pregnant woman, pursuant to Subdivision 6.12.a., shall be located at the waist under any protective apron being worn by the woman;
6.18.a.3. An individual monitoring device used for monitoring the eye dose equivalent, to demonstrate compliance with Subparagraph 6.5.a.2.A., shall be located at the neck (collar), outside any protective apron being worn by the monitored individual, or at an unshielded location closer to the eye;
6.18.a.4. An individual monitoring device used for monitoring the dose to the extremities, to demonstrate compliance with Paragraph 6.5.a.2., shall be worn on the extremity likely to receive the highest exposure. Each individual monitoring device shall be oriented to measure the highest dose to the extremity being monitored;
6.18.a.5. An individual monitoring device used for monitoring the dose to an embryo or fetus of a declared pregnant woman, pursuant to Subdivision 6.12.a., shall be located at the waist under any protective apron being worn by the woman;
6.18.a.6. An individual monitoring device used for monitoring the eye dose equivalent, to demonstrate compliance with Subparagraph 6.5.a.2.A., shall be located at the neck (collar), outside any protective apron being worn by the monitored individual, or at an unshielded location closer to the eye;
6.18.a.7. An individual monitoring device used for monitoring the dose to the extremities, to demonstrate compliance with Subparagraph 6.5.a.2.B., shall be worn on the extremity likely to receive the highest exposure. Each individual monitoring device shall be oriented to measure the highest dose to the extremity being monitored.
6.19. Control of Access to High Radiation Areas.
6.19.a. The registrant shall ensure that each entrance or access point to a high radiation area has one or more of the following features:
6.19.a.1. A control device that, upon entry into the area, causes the level of radiation to be reduced below that level at which an individual might receive a deep dose equivalent of one (1) mSv (one-tenth [0.1] Rem) in one (1) hour at thirty (30) centimeters from the source of radiation or from any surface that the radiation penetrates; or
6.19.a.2. A control device that energizes a conspicuous visible or audible alarm signal so that the individual entering the high radiation area and the supervisor of the activity are made aware of the entry; or
6.19.a.3. Entryways that are locked, except during periods when access to the areas is required, with positive control over each individual entry.
6.19.b. In place of the controls required by Subdivision 6.19.a. for a high radiation area, the registrant may substitute continuous direct or electronic surveillance that is capable of preventing unauthorized entry.
6.19.c. The registrant may apply to the agency for approval of alternative methods for controlling access to high radiation areas.
6.19.d The registrant shall establish the controls required by Subdivisions 6.19.a. and c. in a way that does not prevent individuals from leaving a high radiation area.
6.19.e. The registrant is not required to control each entrance or access point to a room or other area that is a high radiation area solely because of the presence of radioactive materials prepared for transport and packaged and labeled in accordance with the rules of the Department of Transportation provided that:
6.19.e.1. The packages do not remain in the area longer than three (3) days; and
6.19.e.2. The dose rate at 1 meter from the external surface of any package does not exceed one tenth (0.1) mSv (one one-hundredth [0.01] Rem) per hour.
6.19.f. The registrant is not required to control entrance or access to rooms or other areas in hospitals solely because of the presence of patients containing radioactive material, provided that there are personnel in attendance who are taking the necessary precautions to prevent the exposure of individuals to radiation or radioactive material in excess of the established limits in Section 6. and to operate within the ALARA provisions of the registrant's radiation protection program.
6.19.g. The registrant is not required to control entrance or access to rooms or other areas containing sources of radiation capable of producing a high radiation area as described in Subsection 6.19. if the registrant has met all the specific requirements for access and control specified in other applicable Sections of this rule, such as, Section 7. for x-rays in the healing arts, Section 9. for industrial radiography, and Section 10. for particle accelerators.
6.20. Control of Access to Very High Radiation Areas.
6.20.a. In addition to the requirements in Subsection 6.19., the registrant shall institute measures to ensure that an individual is not able to gain unauthorized or inadvertent access to areas in which radiation levels could be encountered at five (5) Gy (five hundred [500] Rad) or more in one (1) hour at one (1) meter from a source of radiation or any surface through which the radiation penetrates. This requirement does not apply to rooms or areas in which diagnostic x-ray systems are the only source of radiation, or to non-self-shielded irradiators.
6.20.b. The registrant is not required to control entrance or access to rooms or other areas containing sources of radiation capable of producing a very high radiation area as described in Subdivision 6.20.a. if the registrant has met all the specific requirements for access and control specified in other applicable Sections of this rule, such as, Section 7. for x- rays in the healing arts, Section 9. for industrial radiography, and Section 10. for particle accelerators.
6.21. Control of Access to Very High Radiation Areas -- Irradiators.
6.21.a. Subsection 6.21. applies to registrants with sources of radiation in non-self-shielded irradiators. Subsection 6.21. does not apply to sources of radiation that are used in teletherapy, in industrial radiography, or in completely self-shielded irradiators in which the source of radiation is both stored and operated within the same shielding radiation barrier and, in the designed configuration of the irradiator, is always physically inaccessible to any individual and cannot create high levels of radiation in an area that is accessible to any individual.
6.21.b. Each area in which there may exist radiation levels in excess of five (5) Gy (five hundred [500] Rad) in one (1) hour at one (1) meter from a source of radiation that is used to irradiate materials shall meet the following requirements:
6.21.b.1. Each entrance or access point shall be equipped with entry control devices which:
6.21.b.1.A. Function automatically to prevent any individual from inadvertently entering a very high radiation area; and
6.21.b.1.B. Permit deliberate entry into the area only after a control device is actuated that causes the radiation level within the area, from the source of radiation, to be reduced below that at which it would be possible for an individual to receive a deep dose equivalent in excess of one (1) mSv (one tenth [0.1] Rem) in one (1) hour; and
6.21.b.1.C. Prevent operation of the source of radiation if it would produce radiation levels in the area that could result in a deep dose equivalent to an individual in excess of one (1) mSv (one tenth [0.1] Rem) in one (1) hour.
6.21.b.2. Additional control devices shall be provided so that, upon failure of the entry control devices to function as required by Paragraph 6.21.b.1.:
6.21.b.2.A. The radiation level within the area, from the source of radiation, is reduced below that at which it would be possible for an individual to receive a deep dose equivalent in excess of one (1) mSv (one tenth [0.1] Rem) in one (1) hour; and
6.21.b.2.B. Conspicuous visible and audible alarm signals are generated to make an individual attempting to enter the area aware of the hazard and at least one other authorized individual, who is physically present, familiar with the activity, and prepared to render or summon assistance, aware of the failure of the entry control devices.
6.21.b.3. The registrant shall provide control devices so that, upon failure or removal of physical radiation barriers other than the sealed source's shielded storage container:
6.21.b.3.A. The radiation level from the source of radiation is reduced below that at which it would be possible for an individual to receive a deep dose equivalent in excess of one (1) mSv (one tenth [0.1] Rem) in 1 hour; and
6.21.b.3.B. Conspicuous visible and audible alarm signals are generated to make potentially affected individuals aware of the hazard and the registrant or at least one other individual, who is familiar with the activity and prepared to render or summon assistance, aware of the failure or removal of the physical barrier.
6.21.b.4. When the shield for stored sealed sources is a liquid, the registrant shall provide means to monitor the integrity of the shield and to signal, automatically, loss of adequate shielding.
6.21.b.5. Physical radiation barriers that comprise permanent structural components, such as walls, that have no credible probability of failure or removal in ordinary circumstances need not meet the requirements of Paragraphs 6.21.b.3. and 4.
6.21.b.6. Each area shall be equipped with devices that will automatically generate conspicuous visible and audible alarm signals to alert personnel in the area before the source of radiation can be put into operation and in time for any individual in the area to operate a clearly identified control device, which must be installed in the area and which can prevent the source of radiation from being put into operation.
6.21.b.7. Each area shall be controlled by use of such administrative procedures and such devices as are necessary to ensure that the area is cleared of personnel prior to each use of the source of radiation.
6.21.b.8. Each area shall be checked by a radiation measurement to ensure that, prior to the first individual's entry into the area after any use of the source of radiation, the radiation level from the source of radiation in the area is below that at which it would be possible for an individual to receive a deep dose equivalent in excess of one (1) mSv (one tenth [0.1] Rem) in 1 hour.
6.21.b.9. The entry control devices required in Paragraph 6.21.b.1. shall be tested for proper functioning. See Subsection 6.42. for recordkeeping requirements.
6.21.b.9.A. Testing shall be conducted prior to initial operation with the source of radiation on any day, unless operations were continued uninterrupted from the previous day; and
6.21.b.9.B. Testing shall be conducted prior to resumption of operation of the source of radiation after any unintentional interruption; and
6.21.b.9.C. The registrant shall submit and adhere to a schedule for periodic tests of the entry control and warning systems.
6.21.b.10. The registrant shall not conduct operations, other than those necessary to place the source of radiation in safe condition or to effect repairs on controls, unless control devices are functioning properly.
6.21.b.11. Entry and exit portals that are used in transporting materials to and from the irradiation area, and that are not intended for use by individuals, shall be controlled by such devices and administrative procedures as are necessary to physically protect and warn against inadvertent entry by any individual through these portals. Exit portals for irradiated materials shall be equipped to detect and signal the presence of any loose radioactive material that is carried toward such an exit and automatically to prevent loose radioactive material from being carried out of the area.
6.21.c. Registrants, or applicants for registrations for sources of radiation within the purview of Subdivision 6.21.b. which will be used in a variety of positions or in locations, such as open fields or forests, that make it impracticable to comply with certain requirements of Subdivision 6.21.b., such as those for the automatic control of radiation levels, may apply to the agency for approval of alternative safety measures. Alternative safety measures shall provide personnel protection at least equivalent to those specified in Subdivision 6.21.b. At least one of the alternative measures shall include an entry-preventing interlock control based on a measurement of the radiation that ensures the absence of high radiation levels before an individual can gain access to the area where such sources of radiation are used.
6.21.d. The entry control devices required by Subdivisions 6.21.b. and c. shall be established in such a way that no individual will be prevented from leaving the area.
6.22. Use of Process or Other Engineering Controls. The registrant shall use, to the extent practicable, process or other engineering controls, such as, containment or ventilation, to control the concentrations of radioactive material in air.
6.23. Use of Other Controls. When it is not practicable to apply process or other engineering controls to control the concentrations of radioactive material in air to values below those that define an airborne radioactivity area, the registrant shall, consistent with maintaining the total effective dose equivalent ALARA, increase monitoring and limit intakes by one or more of the following means:
6.23.a. Control of access; or
6.23.b. Limitation of exposure times; or
6.23.c. Use of respiratory protection equipment; or
6.23.d. Other controls.
6.24. Use of Individual Respiratory Protection Equipment.
6.24.a. If the registrant uses respiratory protection equipment to limit intakes pursuant to Subsection 6.23:
6.24.a.1. Except as provided in Paragraph 6.24.a.2., the registrant shall use only respiratory protection equipment that is tested and certified or had certification extended by the National Institute for Occupational Safety and Health and the Mine Safety and Health Administration;
6.24.a.2. The registrant may use equipment that has not been tested or certified by the National Institute for Occupational Safety and Health and the Mine Safety and Health Administration has not had certification extended by the National Institute for Occupational Safety and Health and the Mine Safety and Health Administration, or for which there is no schedule for testing or certification, provided the registrant has submitted to the agency and the agency has approved an application for authorized use of that equipment, including a demonstration by testing, or a demonstration on the basis of test information, that the material and performance characteristics of the equipment are capable of providing the proposed degree of protection under anticipated conditions of use;
6.24.a.3. The registrant shall implement and maintain a respiratory protection program that includes:
6.24.a.3.A. Air sampling sufficient to identify the potential hazard, permit proper equipment selection, and estimate exposures; and
6.24.a.3.B. Surveys and bioassays, as appropriate, to evaluate actual intakes; and
6.24.a.3.C. Testing of respirators for operability immediately prior to each use; and
6.24.a.3.D. Written procedures regarding selection, fitting, issuance, maintenance, and testing of respirators, including testing for operability immediately prior to each use; supervision and training of personnel; monitoring, including air sampling and bioassays; and record keeping; and
6.24.a.3.E. Determination by a physician prior to initial fitting of respirators, and at least every twelve (12) months thereafter, that the individual user is physically able to use the respiratory protection equipment;
6.24.a.4. The registrant shall issue a written policy statement on respirator usage covering:
6.24.a.4.A. The use of process or other engineering controls, instead of respirators; and
6.24.a.4.B. The routine, nonroutine, and emergency use of respirators; and
6.24.a.4.C. The length of periods of respirator use and relief from respirator use;
6.24.a.5. The registrant shall advise each respirator user that the user may leave the area at any time for relief from respirator use in the event of equipment malfunction, physical or psychological distress, procedural or communication failure, significant deterioration of operating conditions, or any other conditions that might require such relief;
6.24.a.6. The registrant shall use respiratory protection equipment within the equipment manufacturer's expressed limitations for Type And mode of use and shall provide proper visual, communication, and other special capabilities, such as adequate skin protection, when needed.
6.24.b. When estimating exposure of individuals to airborne radioactive materials, the registrant may make allowance for respiratory protection equipment used to limit intakes pursuant to Subsection 6.23., provided that the following conditions, in addition to those in Subdivision 6.24.a., are satisfied:
6.24.b.1. The registrant selects respiratory protection equipment that provides a protection factor, specified in Table 64-23 E, greater than the multiple by which peak concentrations of airborne radioactive materials in the working area are expected to exceed the values specified in Table 64-23 F, Table I, column 3. However, if the selection of respiratory protection equipment with a protection factor greater than the peak concentration is inconsistent with the goal specified in Subsection 6.23. of keeping the total effective dose equivalent ALARA, the registrant may select respiratory protection equipment with a lower protection factor provided that such a selection would result in a total effective dose equivalent that is ALARA. The concentration of radioactive material in the air that is inhaled when respirators are worn may be initially estimated by dividing the average concentration in air, during each period of uninterrupted use, by the protection factor. If the exposure is later found to be greater than initially estimated, the corrected value shall be used; if the exposure is later found to be less than initially estimated, the corrected value may be used;
6.24.b.2. The registrant shall obtain authorization from the agency before assigning respiratory protection factors in excess of those specified in Table 64-23 E. The agency may authorize a registrant to use higher protection factors on receipt of an application that:
6.24.b.2.A. Describes the situation for which a need exists for higher protection factors; and
6.24.b.2.B. Demonstrates that the respiratory protection equipment provides these higher protection factors under the proposed conditions of use.
6.24.c. In an emergency, the registrant shall use as emergency equipment only respiratory protection equipment that has been specifically certified or had certification extended for emergency use by the National Institute for Occupational Safety and Health and the Mine Safety and Health Administration.
6.24.d. The registrant shall notify the agency in writing at least thirty (30) days before the date that respiratory protection equipment is first used pursuant to either Paragraph 6.24.a. or b.
6.25. Storage and Control of Registered Sources of Radiation.
6.25.a. The registrant shall secure registered radioactive material from unauthorized removal or access.
6.25.b. The registrant shall maintain constant surveillance, and use devices or administrative procedures to prevent unauthorized use of registered radioactive material that is in an unrestricted area and that is not in storage.
6.25.c. The registrant shall secure registered radiation machines from unauthorized removal.
6.25.d. The registrant shall use devices or administrative procedures to prevent unauthorized use of registered radiation machines.
6.25.e. Sources of radiation shall be secured against unauthorized removal from the place of storage and shall be provided with reasonable protection against loss, leakage, or dispersion be the effects of fire or water.
6.26. Caution Signs
6.26.a. Standard Radiation Symbol. Unless otherwise authorized by the agency, the symbol prescribed by Subsection 6.26. shall use the colors magenta, or purple, or black on yellow background. The symbol prescribed is the three-bladed design as follows:
- Cross-hatched area is to be magenta, or purple, or black, and 2. The background is to be yellow.
Radiation Symbol
6.26.b. Exception ot Color Requirements for Standard Radiation Symbol. Notwithstanding the requirements of Subdivision 6.26.a., registrants are authorized to label sources, source holders, or device components containing sources of radiation that are subjected to high temperatures, with conspicuously etched or stamped radiation caution symbols and without a color requirement.
6.26.c. Additional Information on Signs and Labels. In addition to the contents of signs and labels prescribed in Section 6., the registrant may provide, on or near the required signs and labels, additional information, as appropriate, to make individuals aware of potential radiation exposures and to minimize the exposures.
6.27. Posting Requirements.
6.27.a. Posting of Radiation Areas. The registrant shall post each radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, RADIATION AREA."
6.27.b. Posting of High Radiation Areas. The registrant shall post each high radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, HIGH RADIATION AREA" or "DANGER, HIGH RADIATION AREA."
6.27.c. Posting of Very High Radiation Areas. The registrant shall post each very high radiation area with a conspicuous sign or signs bearing the radiation symbol and words "GRAVE DANGER, VERY HIGH RADIATION AREA."
6.27.c.1. Each entrance or access point to a high radiation area shall be:
6.27.c.1.A. Equipped with a control device which shall cause the level of radiation to be reduced below that at which an individual might receive a dose of one hundred (100) milliRems in one (1) hour upon entry into the area; or
6.27.c.1.B. Equipped with a control device which shall energize a conspicuous visible or audible alarm signal in such a manner that the individual entering the high radiation area and the registrant or a supervisor of the activity are made aware of the entry; or
6.27.c.1.C. Maintained locked except during periods when access to the area is required, with positive control over each individual entry.
6.27.c.1.D. The controls required by Paragraph 6.27.c.1. shall be established in such a way that no individual will be prevented from leaving a high radiation area.
6.27.c.2. In the case of a high radiation area established for a period of thirty (30) days or less, direct surveillance to prevent unauthorized entry may be substituted for the controls required by Paragraph 6.21.b.1.
6.27.c.3. Any registrant may apply to the agency for approval of methods not included in Subdivisions 6.21.b. and c. for controlling access to high radiation areas. The agency will approve the proposed alternatives if the registrant demonstrates that the alternative methods of control will prevent unauthorized entry into a high radiation area, and that the requirement of Subdivision 6.21.b. is met.
6.27.d. Posting of Airborne Radioactivity Areas. The registrant shall post each airborne radioactivity area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, AIRBORNE RADIOACTIVITY AREA" or "DANGER, AIRBORNE RADIOACTIVITY AREA."
6.27.e. Posting of Areas or Rooms in Which Registered Material is Used or Stored. The registrant shall post each area or room in which there is used or stored an amount of registered material exceeding 10 times the quantity of such material specified in Table 64-23 G with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIALS" or "DANGER, RADIOACTIVE MATERIALS."
6.28. Exceptions to Posting Requirements.
6.28.a. A registrant is not required to post caution signs in areas or rooms containing sources of radiation for periods of less than 8 hours, if each of the following conditions is met:
6.28.a.1. The sources of radiation are constantly attended during these periods by an individual who takes the precautions necessary to prevent the exposure of individuals to sources of radiation in excess of the limits established in Section 6.; and
6.28.a.2. The area or room is subject to the registrant's control.
6.28.b. Rooms or other areas in hospitals that are occupied by patients are not required to be posted with caution signs pursuant to Subsection 6.27. provided that the requirements of Paragraphs 11.38.b.2. or 11.44.b.3. of this rule are met.
6.28.c. Rooms or other areas in hospitals that are occupied by patients are not required to be posted with caution signs, provided that:
6.28.c.1. A patient being treated with a permanent implant could be released from confinement pursuant to Subsection 11.26. of this rule; or
6.28.c.2. A patient being treated with a therapeutic radiopharmaceutical could be released from confinement pursuant to Subdivision 11.38.c. of this rule.
6.28.d. A room or area is not required to be posted with a caution sign because of the presence of a sealed source provided the radiation level at thirty (30) centimeters from the surface of the sealed source container or housing does not exceed five one-hundredths (0.05) mSv (five one-thousandths [0.005] Rem) per hour.
6.28.e. A room or area is not required to be posted with a caution sign because of the presence of radiation machines used solely for diagnosis in the healing arts.
6.29. Labeling Containers and Radiation Machines.
6.29.a. The registrant shall ensure that each container of registered material bears a durable, clearly visible label bearing the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL." The label shall also provide information, such as the radionuclides present, an estimate of the quantity of radioactivity, the date for which the activity is estimated, radiation levels, kinds of materials, and mass enrichment, to permit individuals handling or using the containers, or working in the vicinity of the containers, to take precautions to avoid or minimize exposures.
6.29.b. Each registrant shall, prior to removal or disposal of empty uncontaminated containers to unrestricted areas, remove or deface the radioactive material label or otherwise clearly indicate that the container no longer contains radioactive materials.
6.29.c. Each registrant shall ensure that each radiation machine is labeled in a conspicuous manner which cautions individuals that radiation is produced when it is energized.
6.30. Exemptions to Labeling Requirements.
6.30.a. A registrant is not required to label:
6.30.a.1. Containers holding registered material in quantities less than the quantities listed in Table 64-23 G ; or
6.30.a.2. Containers holding registered material in concentrations less than those specified in Table III of Table 64-23 F; or
6.30.a.3. Containers attended by an individual who takes the precautions necessary to prevent the exposure of individuals in excess of the limits established by Section 6.; or
6.30.a.4. Containers when they are in transport and packaged and labeled in accordance with the rules of the Department of Transportation3; or
6.30.a.5. Containers that are accessible only to individuals authorized to handle or use them, or to work in the vicinity of the containers, if the contents are identified to these individuals by a readily available written record. Examples of containers of this Type Are containers in locations such as water-filled canals, storage vaults, or hot cells. The record shall be retained as long as the containers are in use for the purpose indicated on the record; or
6.30.a.6. Installed manufacturing or process equipment, such as piping and tanks.
6.31. Procedures for Receiving and Opening Packages.
6.31.a. Each registrant who expects to receive a package containing quantities of radioactive material in excess of a Type A quantity, as defined in Section 14. and Table 64-23 Ee of this rule, shall make arrangements to receive:
6.31.a.1. The package when the carrier offers it for delivery; or
6.31.a.2. The notification of the arrival of the package at the carrier's terminal and to take possession of the package expeditiously.
6.31.b. Each registrant shall:
6.31.b.1. Monitor the external surfaces of a labeled4 package for radioactive contamination unless the package contains only radioactive material in the form of gas or in special form as defined in Section 3. of this rule; and
6.31.b.2. Monitor the external surfaces of a labeled package for radiation levels unless the package contains quantities of radioactive material that are less than or equal to the Type A quantity, as defined in Section 3. and Table Ee of this rule; and
6.31.b.3. Monitor all packages known to contain radioactive material for radioactive contamination and radiation levels if there is evidence of degradation of package integrity, such as packages that are crushed, wet, or damaged.
6.31.c. The registrant shall perform the monitoring required by Subdivision 6.31.b. as soon as practicable after receipt of the package, but not later than three (3) hours after the package is received at the registrant's facility if it is received during the registrant's normal working hours or if there is evidence of degradation of package integrity, such as a package that is crushed, wet, or damaged. If a package is received after working hours, and has no evidence of degradation of package integrity, the package shall be monitored no later than three (3) hours from the beginning of the next working day.
6.31.d. The registrant shall immediately notify the final delivery carrier and, by telephone and either telegram, or facsimile, the agency when:
6.31.d.1. Removable radioactive surface contamination exceeds the limits of Subdivision 14.14.h. of this rule; or
6.31.d.2. External radiation levels exceed the limits of Subdivisions 14.14.j. and k. of this rule.
6.31.e. Each registrant shall:
6.31.e.1. Establish, maintain, and retain written procedures for safely opening packages in which radioactive material is received; and
6.31.e.2. Ensure that the procedures are followed and that due consideration is given to special instructions for the type of package being opened.
6.31.f. Registrants transferring special form sources in vehicles owned or operated by the registrant to and from a work site are exempt from the contamination monitoring requirements of Subsection 6.31.b., but are not exempt from the monitoring requirement in Subdivision 6.31.b. for measuring radiation levels that ensures that the source is still properly lodged in its shield.
6.32. Waste Disposal
6.32.a. General Requirements - No registrant shall dispose of any registered radioactive material except:
6.32.a.1. By transfer to an authorized recipient as provided in Subsection 6.39. or in Section 11. of this rule or to the Department of Energy; or
6.32.a.2. By release in effulents within limits of Subsection 6.13.; or
6.32.a.3. As authorized pursuant to Subsection 6.33., Subsection 6.34., Subsection 6.35., or Subsection 6.36.; or
6.32.a.4. By decay in storage.
6.32.b. A person shall be specifically registered to receive waste containing registered material from other persons for:
6.32.b.1. Treatment prior to disposal; or
6.32.b.2. Treatment or disposal by incineration; or
6.32.b.3. Decay in storage; or
6.32.b.4. Disposal at a land disposal facility; or
6.32.b.5. Storage until transferred to a storage or disposal facility authorized to receive the waste.
6.33. Methods of Obtaining Approval of Proposed Disposal Procedures
6.33.a. Any registrant or applicant for registration may apply to the agency for approval of proposed procedures to dispose of radioactive material in a manner not otherwise authorized in this Section.
6.33.b. Each application shall include a description of the radioactive material, including the quantities and kinds of radioactive material and levels of radioactivity involved, and the proposed manner and conditions of disposal.
6.33.c. The application, where appropriate should also include an analysis and evaluation of pertinent information as to the nature of the environment, including topographical, geological, meteorological and hydrological characteristics; usage of ground and surface waters in the general area; the nature and location of other potentially affected facilities; and procedures to be observed to minimize the risk of unexpected or hazardous exposures.
6.33.d. The agency will not approve any application for a registration to receive radioactive material from other persons for disposal on land not owned by a state or the federal government.
6.34. Disposal by Release Into Sanitary Sewerage Systems
6.34.a. No registrant shall dispose of radioactive material into a sanitary sewerage system unless:
6.34.a.1. It is readily soluble or dispersible in water;
6.34.a.2. The quantity of any registered radioactive material released into the system by the registrant in any one day does not exceed the larger of the following:
6.34.a.3. The quantity of registered radioactive material that the registrant releases into the sewer in one (1) month divided by the average monthly volume of water released into the sewer by the registrant does not exceed the concentration listed in Table III of Table 64-23 F; and
6.34.a.4. If more than one radionuclide is released, the following conditions must also be satisfied:
6.34.a.4.A. The registrant shall determine the fraction of the limit in Table III of Table 64-23 F represented by discharges into sanitary sewerage by dividing the actual monthly average concentration of each radionuclide released by the registrant into the sewer by the concentration of that radionuclide listed in Table III of Table 64-23 F; and
6.34.a.4.B. The sum of the fractions for each radionuclide required by Section 6.34.a.iii. does not exceed unity; and
6.34.a.4.C. The total quantity of registered radioactive material that the registrant releases into the sanitary sewerage in a year does not exceed one hundred eighty five (185) GBq (five [5] Ci) of Hydrogen-3, thirty seven (37) GBq (one [1] Ci) of Carbon-14, and thirty seven (37) GBq (one [1] Ci) of all other radioactive materials combined.
6.34.b. Excreta from individuals undergoing medical diagnosis or therapy with radioactive material are not subject to the limitations contained in Subdivision 6.34.a.
6.35. Treatment or Disposal by Incineration. A registrant may treat or dispose of registered material by incineration only in the form and concentration specified in Subsection 6.36. or as specifically approved by the agency pursuant to Subsection 6.33.
6.36. Disposal of Specific Wastes.
6.36.a. A registrant may dispose of the following registered material as if it were not radioactive:
6.36.a.1. One and eighty five one-hundredths (1.85) kBq (five one-hundredths [0.05] Ci), or less, of Hydrogen-3 or Carbon-14 per gram of medium used for liquid scintillation counting; and
6.36.a.2. One and eighty five one-hundredths (1.85) kBq (five one-hundredths [0.05] Ci), or less, of Hydrogen-3 or Carbon-14 per gram of animal tissue, averaged over the weight of the entire animal.
6.36.b. A registrant shall not dispose of tissue pursuant to Paragraph 6.36.a.2. in a manner that would permit its use either as food for humans or as animal feed.
6.36.c. The registrant shall maintain records in accordance with Subsection 6.48.
6.37. Transfer of Material
6.37.a. No registrant shall transfer radioactive material except as authorized pursuant to this Section.
6.37.b. Any registrant may transfer radioactive material:
6.37.b.1. To the U.S. Nuclear Regulatory Commission;
6.37.b.2. To any person authorized to receive such material under terms of a general license or its equivalent, or a specific license or equivalent licensing document, issued by the U.S. Nuclear Regulatory Commission, or any agreement state, or to any person otherwise authorized to receive such material by the federal government or any agency thereof, or any agreement state; or,
6.37.b.3. As otherwise authorized by the agency in writing.
6.38. Transfer for Disposal and Manifests.
6.38.a. The requirements of Subsection 6.38. and Table 64-23 H are designed to control transfers of low-level radioactive waste intended for disposal at a licensed low-level radioactive waste disposal facility, establish a manifest tracking system, and supplement existing requirements concerning transfers and recordkeeping for those wastes.
6.38.b. Each shipment of radioactive waste designated for disposal at a licensed low-level radioactive waste disposal facility shall be accompanied by a shipment manifest as specified in Table 64-23 H i.
6.38.c. Each shipment manifest shall include a certification by the waste generator as specified in Table 64-23 H ii.
6.38.d. Each person involved in the transfer of waste for disposal or in the disposal of waste, including the waste generator, waste collector, waste processor, and disposal facility operator, shall comply with the requirements specified in Table 64-23 H iii.
6.39. Compliance with Environmental and Health Protection Rules.
6.39.a. Nothing in Subsections 6.32., 6.33., 6.34., 6.35., 6.36. or 6.37. relieves the registrant from complying with other applicable federal, state and local rules governing any other toxic or hazardous properties of materials that may be disposed of to Subsections 6.32., 6.33., 6.34., 6.35., 6.36. or 6.37.
6.40. Intrastate Transportation of Radioactive Material
6.40.a. The provisions of this part apply to transportation of radioactive material, or the delivery of radioactive material to a carrier for transportation, which is not subject to the rules and rules of the U.S. Department of Transportation, the U.S. Postal Service and other federal agencies.
6.40.b. No registrant shall transport any radioactive material outside of the confines of his plant or other authorized location of use, or deliver any radioactive material to a carrier for transportation, unless the registrant complies with all requirements, appropriate to the mode of transportation, relating to the packaging of the radioactive material, and to the marking and labeling of the package and transporting vehicle, of the rules and regulations, as amended of the U.S. Department of Transportation and other federal agencies regulating the transportation of radioactive material.
6.41. Records
6.41.a. Each registrant shall use SI units Becquerel, Gray, Sievert and Coulomb per kilogram, or the special units Curie, Rad, Rem and Roentgen, including multiples and subdivisions, and shall clearly indicate the units of all quantities on records required by Section 6.
6.41.b. The registrant shall make a clear distinction among the quantities entered on the records required by Section 6., such as, total effective dose equivalent, total organ dose equivalent, shallow dose equivalent, eye dose equivalent or committed effective dose equivalent.
6.41.c. Upon termination of employment of an individual, the individual or agency shall, upon request, be supplied with a summary statement of that individual's radiation dose. This record shall include statements of any circumstances wherein the dose to the employee from any source of radiation, exceeded those specified in this rule. Employee records must be kept available for inspection by the agency during the tenure of employment of an employee and for a period of five years thereafter.
6.41.d. Each registrant shall maintain records in the same units used in this rule, showing the results of surveys and calibrations required to comply with this rule and disposals made under Subsections 6.32. - 6.36. The registrant shall retain these records for three years after the record is made.
6.41.e. Records of individual exposure to radiation and to radioactive material which must be maintained pursuant to the provisions of Subsection 6.46. and records of bioassays, including results of whole body counting examinations, made pursuant to Subdivision 6.6.e. shall be preserved indefinitely or until the agency authorizes their disposal. (Records which must be maintained pursuant to this part may be maintained in the form of microfilms.)
6.41.f. An accurate accounting for all radioactive materials shall be maintained for a radiation installation. Such records shall show radioactive materials received, produced, transferred and disposed, the amounts and form of the radioactive materials, and such information as may be necessary to account for the difference between the amount of radioactive materials, received or produced and the amount on hand. Such records shall be retained for at least five years after the final disposition of any radioactive material.
6.41.g. Copies of all records required under this rule shall be transferred to the agency in the event of termination of the registrant's business operations and at such other times as the agency may direct.
6.42. Records of Surveys.
6.42.a. Each registrant shall maintain records showing the results of surveys and calibrations required by Subsections 6.16. and 6.31.b. The registrant shall retain these records for three (3) years after the record is made.
6.42.b. The registrant shall retain each of the following records until the agency terminates each pertinent registration requiring the record:
6.42.b.1. Records of the results of surveys to determine the dose from external sources of radiation used, in the absence of or in combination with individual monitoring data, in the assessment of individual dose equivalents; and
6.42.b.2. Records of the results of measurements and calculations used to determine individual intakes of radioactive material and used in the assessment of internal dose; and
6.42.b.3. Records showing the results of air sampling, surveys, and bioassays required pursuant to Subparagraphs 6.24.a.3.A. and B.; and
6.42.b.4. Records of the results of measurements and calculations used to evaluate the release of radioactive effluents to the environment.
6.42.c. Upon termination of the registration, the registrant shall permanently store records on Agency Form Y or equivalent, or shall make provision with the agency for transfer to the agency.
6.43. Records of Tests for Leakage or Contamination of Sealed Sources. Records of tests for leakage or contamination of sealed sources [required by Subsection 6.15.] shall be kept in units of becquerel or microcurie and maintained for inspection by the agency for five (5) years after the records are made.
6.44. Records of Prior Occupational Dose.
6.44.a. The registrant shall retain the records of prior occupational dose and exposure history as specified in Subsection 6.9. on agency form y or equivalent until the agency terminates each pertinent registration requiring this record. The registrant shall retain records used in preparing agency form y or equivalent for three (3) years after the record is made.
6.44.b. Upon termination of the registration, the registrant shall permanently store records on Agency Form Y or equivalent, or shall make provision with the agency for transfer to the agency.
6.45. Records of Planned Special Exposures.
6.45.a. For each use of the provisions of Subsection 6.10. for planned special exposures, the registrant shall maintain records that describe:
6.45.a.1. The exceptional circumstances requiring the use of a planned special exposure;
6.45.a.2. The name of the management official who authorized the planned special exposure and a copy of the signed authorization;
6.45.a.3. What actions were necessary;
6.45.a.4. Why the actions were necessary;
6.45.a.5. What precautions were taken to assure that doses were maintained ALARA;
6.45.a.6. What individual and collective doses were expected to result; and
6.45.a.7. The doses actually received in the planned special exposure.
6.45.b. The registrant shall retain the records until the agency terminates each pertinent registration requiring these records.
6.46. Records of Individual Monitoring Results.
6.46.a. Recordkeeping Requirement. Each registrant shall maintain records of doses received by all individuals for whom monitoring was required pursuant to Subsection 6.17., and records of doses received during planned special exposures, accidents, and emergency conditions. Assessments of dose equivalent and records made using units in effect before July 1, 2001. need not be changed. These records shall include, when applicable:
6.46.a.1. The deep dose equivalent to the whole body, eye dose equivalent, shallow dose equivalent to the skin, and shallow dose equivalent to the extremities; and
6.46.a.2. The estimated intake of radionuclides, see Subsection 6.6.;
6.46.a.3. The committed effective dose equivalent assigned to the intake of radionuclides;
6.46.a.4. The specific information used to calculate the committed effective dose equivalent pursuant to Subsection 6.8.c.;
6.46.a.5. The total effective dose equivalent when required by Subsection 6.6.; and
6.46.a.6. The total of the deep dose equivalent and the committed dose to the organ receiving the highest total dose.
6.46.b. Recordkeeping Frequency. The registrant shall make entries of the records specified in Subdivision 6.46.a. at intervals not to exceed one (1) year.
6.46.c. Recordkeeping Format. The registrant shall maintain the records specified in Subdivision 6.46.a. on Agency Form Z, in accordance with the instructions for Agency Form Z, or in clear and legible records containing all the information required by Agency Form Z.
6.46.d. The registrant shall maintain the records of dose to an embryo or fetus with the records of dose to the declared pregnant woman. The declaration of pregnancy, including the estimated date of conception, shall also be kept on file, but may be maintained separately from the dose records.
6.46.e. The registrant shall retain each required form or record until the agency terminates each pertinent registration requiring the record.
6.47. Records of Dose to Individual Members of the Public.
6.47.a. Each registrant shall maintain records sufficient to demonstrate compliance with the dose limit for individual members of the public. See Subsection 6.13.
6.47.b. The registrant shall retain the records required by Subdivision 6.47.a. until the agency terminates each pertinent registration requiring the record.
6.48. Records of Waste Disposal.
6.48.a. Each registrant shall maintain records of the disposal of registered materials made pursuant to Subsections 6.33., 6.34., 6.35. and 6.36., of this rule.
6.48.b. The registrant shall retain the records required by Subdivision 6.48.a. until the agency terminates each pertinent registration requiring the record.
6.49. Records of Testing Entry Control Devices for Very High Radiation Areas.
6.49.a. Each registrant shall maintain records of tests made pursuant to Paragraph 6.21.b.9. on entry control devices for very high radiation areas. These records must include the date, time, and results of each such test of function.
6.49.b. The registrant shall retain the records required by Subdivision 6.49.a. for three (3) years after the record is made.
6.50. Form of Records. Each record required by Section 6. shall be legible throughout the specified retention period. The record shall be the original or a reproduced copy or a microform, provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period or the record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records, such as letters, drawings, and specifications, shall include all pertinent information, such as stamps, initials, and signatures. The registrant shall maintain adequate safeguards against tampering with and loss of records.
6.51. Reports
6.51.a. Report to Employees and Others of Radiation Dosage - Each registrant, at the request of any individual employed or associated with him, shall advise such individual annually of the individual's exposure to radiation as shown in records maintained by the registrant pursuant to Subsection 6.46.
6.51.b. Report to Former Employees and Others of Exposure to Radiation
6.51.b.1. A registrant, at the request of any individual formerly employed or associated with him (i.e., student, craftsman, etc.) shall furnish to such individual a report of his exposure to radiation as shown in records maintained pursuant to Subsection 6.46. Such report shall be furnished within thirty (30) days from the time the request is made and shall cover each calendar quarter of the individual's employment or association involving exposure to radiation, or such lesser period as may be requested by the individual. The report shall also include the results of any calculations and analysis of radioactive material deposited in the body of the individual and made pursuant to the provisions of Subdivision 6.6.e. The report shall be in writing and contain the following statement:
"This report is furnished to you under the provisions of the West Virginia Bureau for Public Health’s rule entitled, Radiological Health Rules. You should preserve this report for future reference."
6.51.b.2. The individual's request should include appropriate identifying data, such as social security number and dates and locations of employment of association.
6.52. Reports of Stolen, Lost, or Missing Registered Sources of Radiation.
6.52.a. Telephone Reports. Each registrant shall report to the agency by telephone as follows:
6.52.a.1. Immediately after its occurrence becomes known to the registrant, stolen, lost, or missing registered radioactive material in an aggregate quantity equal to or greater than one thousand (1,000) times the quantity specified in Appendix C under such circumstances that it appears to the registrant that an exposure could result to individuals in unrestricted areas; or
6.52.a.2. Within thirty (30) days after its occurrence becomes known to the registrant, lost, stolen, or missing registered radioactive material in an aggregate quantity greater than ten (10) times the quantity specified in Table 64-23 G that is still missing;
6.52.a.3. Immediately after its occurrence becomes known to the registrant, a stolen, lost, or missing radiation machine.
6.52.b. Written Reports. Each registrant required to make a report pursuant to Subsection 6.51.a. shall, within thirty (30) days after making the telephone report, make a written report to the agency setting forth the following information:
6.52.b.1. A description of the registered source of radiation involved, including, for radioactive material, the kind, quantity, and chemical and physical form; and, for radiation machines, the manufacturer, model and serial number, Type And maximum energy of radiation emitted;
6.52.b.2. A description of the circumstances under which the loss or theft occurred;
6.52.b.3. A statement of disposition, or probable disposition, of the registered source of radiation involved;
6.52.b.4. Exposures of individuals to radiation, circumstances under which the exposures occurred, and the possible total effective dose equivalent to persons in unrestricted areas;
6.52.b.5. Actions that have been taken, or will be taken, to recover the source of radiation; and
6.52.b.6. Procedures or measures that have been, or will be, adopted to ensure against a recurrence of the loss or theft of registered sources of radiation.
6.52.c. Subsequent to filing the written report, the registrant shall also report additional substantive information on the loss or theft within thirty (30) days after the registrant learns of such information.
6.52.d. The registrant shall prepare any report filed with the agency pursuant to Subsection 6.51. so that names of individuals who may have received exposure to radiation are stated in a separate and detachable portion of the report.
6.53. Notification of Incidents
6.53.a. Immediate Notification- Each registrant shall immediately notify the agency by telephone or facsimile of any incident involving any sources of radiation possessed by him and which may have caused or threatens to cause an individual to receive:
6.53.a.1. A total effective dose equivalent exceeding twenty five one-hundredths (0.25) Sv (twenty five [25] Rem) or more; or
6.53.a.2. An eye dose equivalent exceeding seventy five one-hundredths (0.75) Sv (seventy-five [75]Rem) or more; or
6.53.a.3. A shallow dose equivalent to the skin or extremities or a total organ dose equivalent of two and five-tenths (2.5) Gy (two hundred fifty [250] Rad) or more; or
6.53.a.4. The release of radioactive material, inside or outside of a restricted area, so that, had an individual been present for twenty-four (24) hours, the individual could have received an intake five times the occupational ALI. This provision does not apply to locations where personnel are not normally stationed during routine operations, such as hot cells or process enclosures.
6.53.a.5. A loss of one working week or more of the operation of any facilities affected; or
6.53.a.6. Damage to property to property in excess of one hundred thousand dollars ($100,000).
6.53.b. Twenty-four (24) Hour Notification - Each registrant shall within twenty four (24) hours of discovery of the event, notify the agency by telephone or facsimile of any incident involving any sources of radiation possessed by him and which may have caused or threatens to cause an individual to receive, in a period of twenty four (24) hours:
6.53.b.1. A total dose equivalent exceeding five one-hundredths (0.05) Sv (five [5] Rem); or
6.53.b.2. An eye dose equivalent exceeding fifteen one-hundredths (0.15) Sv (fifteen [15] Rem); or
6.53.b.3. A shallow dose equivalent to the skin or extremities or a total organ dose equivalent exceeding five tenths (0.5) Sv (fifty [50] Rem); or
6.53.c. The release of radioactive material, inside or outside of a restricted area, so that, had an individual been present for twenty four (24) hours, the individual could have received an intake five times the occupational ALI. This provision does not apply to locations where personnel are not normally stationed during routine operations, such as hot-cells or process enclosures; or
6.53.d. A loss of one day or more on the operation of any facilities affected; or
6.53.e. Damage to property in excess of one thousand dollars ($1,000).
6.53.f. Any report filed with the agency pursuant to this part shall be prepared in such a manner that names of individuals who have received exposure to radiation will be stated in a separate part of the report.
6.53.g. Registrants shall make the reports required by Subdivisions 6.52.a and b. by initial contact by telephone to the agency and shall confirm the initial facsimile to the agency.
6.53.h. The registrant shall prepare each report filed with the agency pursuant to Subsection 6.52. so that names of individuals who have received exposure to sources of radiation are stated in a separate and detachable portion of the report.
6.53.i. The provisions of Subsection 6.52. do not apply to doses that result from planned special exposures, provided such doses are within the limits for planned special exposures and are reported pursuant to Subsection 6.54.
6.54. Reports of Exposures, Radiation Levels, and Concentrations of Radioactive Material Exceeding Limits.
6.54.a. In addition to any notification required by Subsection 6.52., each registrant shall make a report in writing within thirty (30) days to the agency after learning of any of the following occurrences:
6.54.a.1. Incidents for which notification is required by Subsection 6.52.;
6.54.a.2. Doses in excess of any of the following:
6.54.a.2.A. The occupational dose limits for adults in Subsection 6.5.;
6.54.a.2.B. The occupational dose limits for a minor in Subsection 6.11.;
6.54.a.2.C. The limits for an embryo or fetus of a declared pregnant woman in Subsection 6.12.;
6.54.a.2.D. The limits for an individual member of the public in Subsection 6.13.;or
6.54.a.2.E. Any applicable limit in the registration;
6.54.a.3. Levels of radiation or concentrations of radioactive material in:
6.54.a.3.A. A restricted area in excess of applicable limits in the registration;
6.54.a.3.B. An unrestricted area in excess of ten (10) times the applicable limit set forth in Section 6. or in the registration, whether or not involving exposure of any individual in excess of the limits in Subsection 6.13.;or
6.54.a.3.C. For registrants subject to the provisions of the Environmental Protection Agency's generally applicable Environmental Radiation Standards in 40 CFR 190, levels of radiation or releases of radioactive material in excess of those standards, or of registration conditions related to those standards.
6.54.b. In any case where a registrant is required pursuant to the provisions of this Section to report to the agency any exposure of an individual to radiation or concentrations of radioactive material, the registrant shall no later than the making of such report to the agency also notify such individual of the nature and extent of exposure. Such notice shall be in writing and shall contain the following statement:
"This report is furnished to you under the provisions of the West Virginia Bureau for Public Health rule entitled, Radiological Health Rules. You should preserve this report for future reference."
6.54.c. Contents of Reports.
6.54.c.1. Each report required by Subdivision 6.53.a. shall describe the extent of exposure of individuals to radiation and radioactive material, including, as appropriate:
6.54.c.1.A. Estimates of each individual's dose;
6.54.c.1.B. The levels of radiation and concentrations of radioactive material involved;
6.54.c.1.C. The cause of the elevated exposures, dose rates, or concentrations; and
6.54.c.1.E. Corrective steps taken or planned to ensure against a recurrence, including the schedule for achieving conformance with applicable limits, generally applicable environmental standards, and associated registration conditions.
6.54.d. Each report filed pursuant to Subdivision 6.53.a. shall include for each individual exposed the name, social security account number, and date of birth. With respect to the limit for the embryo or fetus in Subsection 6.12., the identifiers should be those of the declared pregnant woman. The report shall be prepared so that this information is stated in a separate and detachable portion of the report.
6.54.e. All registrants who make reports pursuant to Subdivision 6.53.a. shall submit the report in writing to the agency.
6.55. Reports of Planned Special Exposures. The registrant shall submit a written report to the agency within thirty (30) days following any planned special exposure conducted in accordance with Subsection 6.10., informing the agency that a planned special exposure was conducted and indicating the date the planned special exposure occurred and the information required by Subsection 6.38.
6.56. Reports of Individual Monitoring.
6.56.a. This Section applies to each person registered by the agency to:
6.56.a.1. Possess or use sources of radiation for purposes of industrial radiography pursuant to Sections 9. and 11. of this rule; or
6.56.a.2. Possess or use at any time, for processing or manufacturing for distribution pursuant to Sections 11. or 12. of this rule, radioactive material in quantities exceeding any one of the quantities listed in Table 64-23 D.
6.56.b Each registrant in a category listed in Subdivision 6.55.a. shall submit an annual report of the results of individual monitoring carried out by the registrant for each individual for whom monitoring was required by Subsection 6.17. during that year. The registrant may include additional data for individuals for whom monitoring was provided but not required. The registrant shall use Agency Form Z or equivalent or electronic media containing all the information required by Agency Form Z.
6.56.c. The registrant shall file the report required by Subsection 6.55., covering the preceding year, on or before April 30 of each year. The registrant shall submit the report to the agency.
6.57. Notifications and Reports to Individuals.
6.57.a. Requirements for notification and reports to individuals of exposure to radiation or radioactive material are specified in Subsection 13.4. of this rule.
6.57.b. When a registrant is required pursuant to Subsection 6.53. to report to the agency any exposure of an individual to radiation or radioactive material, the registrant shall also notify the individual. Such notice shall be transmitted at a time not later than the transmittal to the agency, and shall comply with the provisions of Subdivision 13.4.a. of this rule.
6.58. Reports of Leaking or Contaminated Sealed Sources. The registrant shall file a report within five (5) days with the agency if the test for leakage or contamination (required pursuant to Subsection 6.15.) indicates a sealed source is leaking or contaminated. The report shall include the equipment involved, the test results and the corrective action taken.
6.59. Vacating Premises
6.59.a. Each registrant shall, no less than thirty (30) days before vacating or relinquishing possession or control of premises in which radioactive material has been stored or used, notify the agency in writing of intent to vacate and afford the agency the opportunity to survey the premises for contamination. When deemed necessary by the agency the registrant shall decontaminate said premises in such a manner as the agency may authorize and shall not vacate or relinquish possession or control of said premises without written consent of the agency. Quantities to be used in decommissioning are listed in Table 64-23 L.
W. Va. Code R. § 64-23-7 Requirements for Radiation Usage in the Healing Arts
7.1. Scope - This Section establishes requirements for which a registrant is responsible, for use of x-ray equipment by or under the supervision of an individual authorized by and registered in accordance with West Virginia statutes to engage in the healing arts or veterinary medicine. The provisions of this Section are in addition to, and not in substitution for, other applicable provisions of this rule.
7.2. Definitions - As used in this Section, the following definitions apply:
7.2.1. Accessible Surface - the external surface of the enclosure or housing of the radiation producing machine as provided by the manufacturer.
7.2.2. Added Filtration - any filtration which is in addition to the inherent filtration.
7.2.3. Aluminum Equivalent - the thickness of aluminum (type one thousand one hundred [1100] alloy) affording the same attenuation, under specified conditions, as the material in question. (The nominal chemical composition of type one thousand one hundred [1100] aluminum alloy is ninety-nine [99.00] percent minimum aluminum, twelve one-hundredths [0.12] percent copper.)
7.2.4. Assembler - any person engaged in the business of assembling, replacing, or installing one or more components into an x-ray system or subsystem. The term includes the owner of an x-ray system or his or her employee or agent who assembles components into an x-ray system that is subsequently used to provide professional or commercial services.
7.2.5. Attenuation Block - a block or stack, having dimensions twenty (20) centimeters by twenty (20) centimeters by three and eight-tenths (3.8) centimeters, of type 1100 aluminum alloy or other materials having equivalent attenuation.
7.2.6. Automatic Exposure Control (AEC) - a device which automatically controls one or more technique factors in order to obtain at a preselected locations a required quantity of radiation (Includes devices such as phototimers and ion chambers).
7.2.7. Barrier - the material, excluding filters, placed in the useful and scattered beam, for protection purposes, to reduce the radiation exposure.
7.2.8. Beam Axis - a line from the source through the centers of the x-ray fields.
7.2.9. Beam-limiting device - a device which provides a means to restrict the dimensions of the x-ray field.
7.2.10. C-arm X-ray System - an x-ray system in which the image receptor and x-ray tube housing assembly are connected by a common mechanical support system in order to maintain a desired spatial relationship. This system is designed to allow a change in the projection of the beam through the patient without a change in the position of the patient.
7.2.11. Cephalometric Device - a device intended for the radiographic visualization and measurement of the dimensions of the human head.
7.2.12. Certified Components - components of x-ray systems which are subject to regulations promulgated under Public Law 90-602, the Radiation Control for Health and Safety Act of 1968, the Food and Drug Administration.
7.2.13. Certified System - any x-ray system which has one or more certified components.
7.2.14. Changeable Filters - any filter, exclusive of inherent filtration, which can be removed from the useful beam through any electronic, mechanical, or physical process.
7.2.15. Coefficient of Variation - the ratio of the standard deviation to the mean value of a set of observations. It is estimated using the following equation: {FUNC s} = Standard deviation of the observed values; {OVERLINE FUNC ALIGNC x} = Mean value of observations in sample; {FUNC x SUB i} = ith observation in sample; {FUNC n} = Number of observations in sample.
7.2.16. Collimator - a device or mechanism by which the x-ray beam is restricted in size.
7.2.17. Computed Tomography (CT) - the production of a tomogram by the acquisition and computer processing of x-ray transmission data.
7.2.18. Control Panel - that part of the x-ray control upon which are mounted the switches, knobs, pushbuttons, and other hardware necessary for manually setting the technique factors.
7.2.19. Cooling Curve - the graphical relationship between heat units stored and cooling time.
7.2.20. Dead-man Switch - a switch so constructed that circuit-closing contact can be maintained only be continuous pressure on the switch by the operator.
7.2.21. Detector - a device which in the presence of radiation provides a signal or other indication suitable for use in measuring one or more quantities of incident radiation.
7.2.22. Diagnostic-type Protective Tube Housing - an x-ray tube housing so constructed that the leakage radiation at a distance of one (1) meter from the target cannot exceed one hundred (100) milliroentgens in one (1) hour when the tube is operated at its maximum continuous rated current for the maximum rated tube potential.
7.2.23. Diagnostic Source Assembly - the tube housing assembly with a beam-limiting device attached.
7.2.24. Diagnostic X-ray System - an x-ray system designed for irradiation of any part of the human or animal body for the purpose of diagnosis or visualization.
7.2.25. Diagnostic X-ray Imaging System - an assemblage of components for the generation, emission and reception of x-rays and the transformation, storage and visual display of the resultant x-ray image.
7.2.26. Diaphragm - a device or mechanism by which the x-ray beam is restricted in size.
7.2.27. Direct Scattered Radiation - that scattered radiation which has been deviated in direction only by materials irradiated by the useful beam (See "Scattered Radiation").
7.2.28. Entrance Exposure Rate - the exposure free in air per unit time at the point where the center of the useful beam enters the patient.
7.2.29. Field Emission Equipment - equipment which uses an x-ray tube in which electron emission from the cathode is due solely to the action of an electric field.
7.2.30. Filter - the material placed in the useful beam to absorb preferentially selected radiations.
7.2.31. Fluoroscopic Imaging Assembly - a subsystem in which x-ray photons produce a visible image. It includes the image receptor or receptors such as the image intensifier and spot-film device, electrical interlocks, if any, and structural material providing linkage between the image receptor and diagnostic source assembly.
7.2.32. Focal Spot (Actual) - the area projected on the anode on the x-ray tube bombarded by electrons accelerated from the cathode and from which the useful beam originates.
7.2.33. General Purpose Radiographic X-ray System - any radiographic x-ray system which, by design, is not limited to radiographic examination of specific anatomical regions.
7.2.34. Gonadal Shield - a protective barrier for the testes or ovaries.
7.2.35. Half-value Layer (HVL) - the thickness of specified material which attenuates the beam of radiation to an extent such that the exposure rate is reduced to one-half of its original value. In this definition, the contribution of all scattered radiation, other than any which might be present initially in the beam concerned, is deemed to be excluded.
7.2.36. Healing Arts Screening - the testing of human beings using x-ray machines for the detection or evaluation of health indications when such tests are not specifically and individually ordered by a licensed practitioner of the healing arts legally authorized to prescribe such x-ray tests for the purpose of diagnosis or treatment.
7.2.37. Heat Unit - a unit of energy equal to the product of the peak kilovoltage, milliamperes, and seconds, i.e., kVp x mA x second.
7.2.38. Image Intensifier - a device, installed in its housing, which instantaneously converts an x-ray pattern into a corresponding light image of higher intensity.
7.2.39. Image Receptor - any device, such as a fluorescent screen or radiographic film, which transforms incident x-ray photons either into a visible image or into another form which can be made into a visible image by further transformations.
7.2.40. Image Receptor Support - for mammographic systems, that part of the system designed to support the image receptor during mammography.
7.2.41. Inherent Filtration - the filtration of the useful beam provided by the permanently installed components of the tube housing assembly.
7.2.42. Interlock - a device for precluding access to an area of radiation hazard either by preventing entry or by automatically removing the hazard.
7.2.43. Irradiation - the exposure of matter to ionizing radiation.
7.2.44. kV - kilovolts.
7.2.45. kVp - the maximum value of the potential difference across the x-ray tube during an exposure.
7.2.46. kWs - kilowatt second.
7.2.47. Lead Equivalent - the thickness of lead affording the same attenuation, under specified conditions, as the material in question.
7.2.48. Leakage Technique Factors - the technique factors associated with the diagnostic source assembly which are used in measuring leakage radiation. They are defined as follows:
7.2.48.a. For diagnostic source assemblies intended for capacitor energy storage equipment, the maximum-rated peak tube potential and the maximum-rated number of exposures in an hour for operation at the maximum-rated peak tube potential with the quantity of charge per exposure being ten (10) millicoulombs, i.e., ten (10) milliampere seconds, or the minimum obtainable from the unit, whichever is larger;
7.2.48.b. For diagnostic source assemblies intended for field emission equipment rated for pulsed operation, the maximum-rated peak tube potential and the maximum-rated number of x-ray pulses in an hour for operation at the maximum-rated peak tube potential;
7.2.48.c. For all other diagnostic source assemblies, the maximum-rated peak tube potential and the maximum-rated continuous tube current for the maximum-rated peak tube potential.
7.2.49. Light Field - that area of the intersection of the light beam from the beam-limiting device and one (1) of the set of planes parallel to and including the plane of the image receptor, whose perimeter is the locus of points at which the illumination is one-fourth (1/4) of the maximum in the intersection.
7.2.50. Line-voltage Regulation - the difference between the no-load and the load line potentials expressed as a percent of the load line potential. It is calculated using the following equation:
Percent line-voltage regulation = 100 (Vn-Vl)/Vl Vn = No-load line potential; and Vl = Load line potential.
7.2.51. mA - milliampere.
7.2.52. mAs - milliampere second.
7.2.53. Maximum Line Current - the root-mean-square current in the supply line of an x-ray machine operating at its maximum rating.
7.2.54. Mobile X-ray Equipment - x-ray equipment mounted on a permanent base with wheels or casters for moving while completely assembled.
7.2.55. Patient - an individual or animal subjected to healing arts examination, diagnosis, or treatment.
7.2.56. PBL - See Positive Beam Limitation.
7.2.57. Peak Tube Potential - the maximum value of the potential difference across the x-ray tube during an exposure.
7.2.58. Phantom - a volume of material behaving in a manner similar to tissue with respect to the attenuation and scattering of radiation. This requires that both the atomic number (Z) and the density of the material be similar to that of tissue.
7.2.59. PID - a device on dental x-ray equipment used to indicate the beam position and to establish a definite source-surface (skin) distance. It may or may not incorporate or serve as a beam-limiting device.
7.2.60. Portable X-ray Equipment - x-ray equipment designed to be hand-carried.
7.2.61. Position Indicating Device - a device on dental x-ray equipment used to indicate the beam position and to establish a definite source-surface (skin) distance. It may or may not incorporate or serve as a beam-limiting device.
7.2.62. Positive Beam Limitation - the automatic or semi-automatic adjustment of an x-ray beam to the size of the selected image receptor, whereby exposures cannot be made without such adjustment.
7.2.63. Primary Protective Barrier - the material, excluding filters, placed in the useful beam, for protection purposes, to reduce the radiation exposure.
7.2.64. Protective Apron - an apron made of radiation absorbing materials used to reduce radiation exposure.
7.2.65. Protective Glove - a glove made of radiation absorbing materials used to reduce radiation exposure.
7.2.66. Qualified Expert - an individual who has demonstrated to the satisfaction of the agency that he possesses the knowledge and training to measure ionizing radiation, to evaluate safety techniques, and to advise regarding radiation protective needs.
7.2.67. Radiation Detector - a device which in the presence of radiation provides a signal or other indication suitable for use in measuring one or more quantities of incident radiation.
7.2.68. Radiation Therapy Simulation System - a radiographic or fluoroscopic x-ray system intended for localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field.
7.2.69. Radiograph - an image receptor on which the image is created directly or indirectly by an x-ray pattern and results in a permanent record.
7.2.70. Radiographic Imaging System - any system whereby a permanent or semi-permanent image is recorded on an image receptor by the action of ionizing radiation.
7.2.71. Rating - the operating limits as specified by the component manufacturer.
7.2.72. Recording - producing a permanent form of an image resulting from x-ray photons.
7.2.73. Registrant as used in this Section - any person who owns or possesses and administratively controls and x-ray system which is used to deliberately expose humans or animals to the useful beam of the system and is required by the provisions of Sections 4. and 5. of this rule to register with this agency.
7.2.74. Scattered Radiation - radiation that, during passage through matter, has been deviated in direction.
7.2.75. Secondary Protective Barrier - a barrier sufficient to attenuate the stray radiation to the required degree.
7.2.76. Shutter - a device attached to the tube housing assembly which can intercept the entire cross Sectional area of the useful beam and which has a lead equivalency not less than that of the tube housing assembly.
7.2.77. Source-image Distance (SID) - the distance from the source to the center of the input surface of the image receptor.
7.2.78. Source - the focal spot of the x-ray tube.
7.2.79. Spot Film - a radiograph which is made during a fluoroscopic examination to permanently record conditions which exist during that fluoroscopic procedure.
7.2.80. Spot-film Device - a device intended to transport or position a radiographic image receptor between the x-ray source and fluoroscopic image receptor. It includes a device intended to hold a cassette over the input end of an image intensifier for the purpose of making a radiograph.
7.2.81. SSD - the distance between the source and the skin entrance plane of the patient.
7.2.82. Stationary X-ray Equipment - x-ray equipment which is installed in a fixed location.
7.2.83. Stray Radiation - the sum of leakage and scattered radiation.
7.2.84. Technique Factors - the following conditions of operation:
7.2.84.a. For capacitor energy storage equipment, peak tube potential in kV and quantity of charge in mAs;
7.2.84.b. For field emission equipment rated for pulsed operation, peak tube potential in kV, and number of x-ray pulses;
7.2.84.c. For CT x-ray systems designed for pulsed operation, peak tube potential in kV, scan time in seconds, and either tube current in mA, x-ray pulse width in seconds, and the number of x-ray pulses per scan, or the product of tube current, x-ray pulse width, and the number of x-ray pulses in mAs;
7.2.84.d. For CT x-ray systems not designed for pulsed operation, peak tube potential in kV, and either tube current in mA and scan time in seconds, or the product of tube current and exposure time in mAs and the scan time when the scan time and exposure time are equivalent; and
7.2.84.e. For all other equipment, peak tube potential in kV, and either tube current in mA and exposure time in seconds, or the product of tube current and exposure time in mAs.
7.2.85. Termination of Irradiation - the stopping of irradiation in a fashion which will not permit continuance of irradiation without the resetting of operating conditions at the control panel.
7.2.86. Therapeutic-type Tube Housing:
7.2.86.a. For x-ray therapy equipment not capable of operating at five hundred (500) kVp or above, the following definition applies: An x-ray tube housing so constructed that the leakage radiation averaged over any one hundred (100) cm² area at a distance of one meter from the source does not exceed one (1) Roentgen in an hour when the tube is operated at its maximum rated continuous current for the maximum rated tube potential.
7.2.86.b. For x-ray therapy equipment capable of operating at five hundred (500) kVp or above, the following definition applies: An x-ray tube housing so constructed that the leakage radiation averaged over any one hundred (100) cm² area at a distance of one meter from the source does not exceed one-tenth (0.1) percent of useful beam dose rate at one meter from the source for any of its operating conditions.
7.2.87. Tomogram - the depiction of the x-ray attenuation properties of a Section through the body.
7.2.88. Tube Housing Assembly - the tube housing with tube installed. It includes high-voltage or filament transformers and other appropriate elements when such are contained within the tube housing.
7.2.89. Tube Rating Chart - the set of curves which specify the rated limits of operation of the tube in terms of the technique factors.
7.2.90. Useful Beam - the radiation which passes through the tube housing port and the aperture of the beam-limiting device when the exposure switch or timer is activated.
7.2.91. Variable-aperture Beam-limiting Device - a beam-limiting device which has capacity for stepless adjustment of the x-ray field size at a given SID.
7.2.92. Visible Area - that portion of the input surface of the image receptor over which incident x-ray photons are producing a visible image.
7.2.93. X-ray Exposure Control - a device, switch, button or other similar means by which an operator initiates or terminates the radiation exposure. The x-ray exposure control may include such associated equipment as timers and back-up timers.
7.2.94. X-ray Equipment - an x-ray system, subsystem, or component thereof. Types of x-ray equipment are as follows:
7.2.94.a. Mobile X-ray Equipment - x-ray equipment mounted on a permanent base with wheels or casters for moving while completely assembled.
7.2.94.b. Portable X-ray Equipment - x-ray equipment designed to be hand-carried.
7.2.94.c. Stationary X-ray Equipment - x-ray equipment which is installed in a fixed location.
7.2.95. X-ray Field - that area of the intersection of the useful beam and any one of the set of planes parallel to and including the plane of the image receptor, whose perimeter is the locus of points at which the exposure rate is one-fourth of the maximum in the intersection.
7.2.96. X-ray High-voltage Generator - a device which transforms electrical energy from the potential supplied by the x-ray control to the tube operating potential. The device may also include means for transforming alternating current to direct current, filament transformers for the x-ray tubes, high-voltage switches, electrical protective devices, and other appropriate elements.
7.2.97. X-ray System - an assemblage of components for the controlled production of x-rays. It includes minimally an x-ray high-voltage generator, an x-ray control, a tube housing assembly, a beam-limiting device, and the necessary supporting structures. Additional components which function with the system are considered integral parts of the system.
7.2.98 . X-ray Table - a patient support device with its patient support structure (tabletop) interposed between the patient and the image receptor during radiography or fluoroscopy. This includes, but is not limited to, any stretcher equipped with a radiolucent panel and any Table equipped with a cassette tray (or bucky), cassette tunnel, image intensifier, or spot-film device beneath the Tabletop.
7.2.99. X-ray Tube - any electron tube which is designed for the conversion of electrical energy into x-ray energy.
7.3. Use of X-Ray Equipment in the Healing Arts and Administrative Requirements
7.3.a. Radiation Safety Requirements The registrant shall be responsible for directing the operation of the x-ray systems under his administrative control. The registrant or the registrant's agent shall assure that the requirements of this rule are met in the operation of the x-ray systems.
7.3.a.1. An x-ray system which does not meet the provisions of this rule shall not be operated for diagnostic purposes.
7.3.a.2. Individuals who will be operating the x-ray systems shall be adequately instructed in the safe operating procedures and be competent in the safe use of the equipment. See Table 64-23 P for a list of subject matters pertinent to this requirement. The agency may use interview, observation or testing to determine compliance.
7.3.a.3. A chart shall be provided in the vicinity of the diagnostic x-ray system's control panel which specifies, for all examinations performed with that system, the following information:
7.3.a.3.A. Patient's body part and anatomical size, or body part thickness, or age (for pediatrics), versus technique factors to be utilized;
7.3.a.3.B. Type and size of the film or film-screen combination to be used;
7.3.a.3.C. Type and focal distance of the grid to be used, if any;
7.3.a.3.D. Source to image receptor distance to be used (except for dental intra-oral radiography);
7.3.a.3.E. Type and location of placement of patient shielding (e.g., gonad, etc.) to be used; and
7.3.a.3.F. For mammography, indication of kVp or target or filter combination.
7.3.a.4. The registrant shall create and make available to x-ray operators written safety policies, including patient holding and any restrictions of the operating technique required for the safe operation of the particular x-ray system. The operator shall be able to demonstrate familiarity with these procedures.
7.3.a.5. Except for patients who cannot be moved out of the room, only the staff, ancillary personnel or other persons required for the medical procedure or training shall be in the room during the radiographic exposure. Other than the patient being examined:
7.3.a.5.A. All individuals shall be positioned such that no part of the body will be struck by the useful beam unless protected by not less than five-tenths (0.5) millimeter lead equivalent material;
7.3.a.5.B. The x-ray operator, other staff, ancillary personnel, and other persons required for the medical procedure shall be protected from the direct scatter radiation by protective aprons or whole body protective barriers of not less than twenty five one-hundredths (0.25) millimeter lead equivalent material;
7.3.a.5.C. Human patients who cannot be removed from the room shall be protected from the direct scatter radiation by whole body protective barriers of not less than twenty five one-hundredths (0.25) millimeter lead equivalent material or shall be so positioned that the nearest portion of the body is at least two (2) meters from both the tube head and the nearest edge of the image receptor.
7.3.a.6. Gonad shielding of not less than five-tenths (0.5) millimeter lead equivalent material shall be used for human patients, who have not passed the reproductive age, during radiographic procedures in which the gonads are in the useful beam, except for cases in which this would interfere with the diagnostic procedure.
7.3.a.7. Individuals shall not be exposed to the useful beam except for healing arts purposes and unless such exposure has been authorized by a licensed practitioner of the healing arts. This provision specifically prohibits deliberate exposure for the following purposes:
7.3.a.7.A. Exposure of an individual for training, demonstration, or other non-healing arts purposes; and
7.3.a.7.B. Exposure of an individual for the purpose of healing arts screening except as authorized by Paragraph 7.3.a.11.
7.3.a.8. When a patient or film must be provided with auxiliary support during a radiation exposure:
7.3.a.8.A. Mechanical holding devices shall be used when the technique permits. The written safety procedures, required by Paragraph 7.3.a.5., shall list individual projections where holding devices cannot be utilized;
7.3.a.8.B. Written safety procedures, as required by Paragraph 7.3.a.5., shall indicate the requirements for selecting a holder and the procedure the holder shall follow;
7.3.a.8.C. The human holder shall be instructed in personal radiation safety and protected as required by Paragraph 7.3.a.5.;
7.3.a.8.D. No individual shall be used routinely to hold film or patients;
7.3.a.8.E. In those cases where the patient must hold the film, except during intraoral examinations, any portion of the body other than the area of clinical interest struck by the useful beam shall be protected by not less than five-tenths (0.5) millimeter lead equivalent material; and
7.3.a.8.F. Each facility shall have leaded aprons and gloves available in sufficient numbers to provide protection to all personnel who are involved with x-ray operations and who are otherwise not shielded.
7.3.a.9. Procedures and auxiliary equipment designed to minimize patient and personnel exposure commensurate with the needed diagnostic information shall be utilized.
7.3.a.9.A. The speed of the screen and film combinations used shall be the fastest speed consistent with the diagnostic objective of the examinations. Film cassettes without intensifying screens shall not be used for any routine diagnostic radiological imaging, with the exception of veterinary radiography and standard film packets for intra-oral use in dental radiography.
7.3.a.9.B. The radiation exposure to the patient shall be the minimum exposure required to produce images of good diagnostic quality.
7.3.a.9.C. Portable or mobile x-ray equipment shall be used only for examinations where it is impractical to transfer the patients to a stationary x-ray installation.
7.3.a.9.D. X-ray systems subject to Subsection 7.8. shall not be utilized in procedures where the source to patient distance is less than thirty (30) centimeters, except for veterinary systems.
7.3.a.9.E. If grids are used between the patient and the image receptor to decrease scatter to the film and improve contrast, the grid shall:
7.3.a.9.E.1. Be positioned properly, i.e., tube side facing the right direction, and grid centered to the central ray;
7.3.a.9.E.2. If of the focused type, be of the proper focal distance for the SIDs being used.
7.3.a.10. All individuals who are associated with the operation of an x-ray system are subject to the requirements of Subsections 6.5., 6.9., 6.11. and 6.12.of this rule.
7.3.a.11. Healing Arts Screening. Any person proposing to conduct a healing arts program shall not initiate such a program without prior approval of the agency. When requesting such approval, that person shall submit the information outlined in Table 64-23 T. If any information submitted to the agency becomes invalid or outdated, the agency shall be immediately notified.
7.3.a.12. Information and Maintenance Record and Associated Information. The registrant shall maintain the following information for each x-ray system for inspection by the agency:
7.3.a.12.A. Model and serial numbers of all major components, and user's manuals for those components;
7.3.a.12.B. Tube rating charts and cooling curves;
7.3.a.12.C. Records of surveys, calibrations, maintenance, and modifications performed on the x-ray system or systems; and
7.3.a.12.D. A copy of all correspondence with this agency regarding that x-ray system.
7.3.a.13. X-Ray Utilization Log. Except for veterinary facilities, each facility shall maintain a record containing the patient's name, the type of examinations, and the dates the examinations were performed. When the patient or film must be provided with human auxiliary support, the name of the human holder shall be recorded.
7.3.b. X-Ray Film Processing Facilities and Practices.
7.3.b.1. Each installation using a radiographic x-ray system and using analog image receptors (e.g. radiographic film) shall have available suitable equipment for handling and processing radiographic film in accordance with the following provisions:
7.3.b.1.A. Manually developed film:
7.3.b.1.A.1. Processing tanks shall be constructed of mechanically rigid, corrosion resistant material; and
7.3.b.1.A.2. The temperature of solutions in the tanks shall be maintained within the range of sixty (60) oF to eighty (80) oF (sixteen [16] oC to twenty seven [27] oC). Film shall be developed in accordance with the time-temperature relationships recommended by the film manufacturer, or, in the absence of such recommendations, with the time-temperature chart in Table 64-23 M.
7.3.b.1.A.3. Devices shall be utilized which will indicate the actual temperature of the developer and signal the passage of a preset time appropriate to the developing time required.
7.3.b.1.B. Automatic processors and other closed processing systems:
7.3.b.1.B.1. Films shall be developed in accordance with the time-temperature relationships recommended by the film manufacturer; in the absence of such recommendations, the film shall be developed using Table 64-23 N.
7.3.b.1.B.2. The specified developer temperature and immersion time shall be posted in the darkroom or on the automatic processor.
7.3.b.1.B.3. Processing deviations from the requirements of Paragraph 7.3.b.1. shall be documented by the registrant in such manner that the requirements are shown to be met or exceeded (e.g., extended processing, and special rapid chemistry).
7.3.b.2. Other Requirements.
7.3.b.2.A. Pass boxes, if provided, shall be so constructed as to exclude light from the darkroom when cassettes are placed in or removed from the boxes, and shall incorporate adequate shielding from stray radiation to prevent exposure of undeveloped film.
7.3.b.2.B. The darkroom shall be light tight and use proper safelighting such that any film type in use exposed in a cassette to x-radiation sufficient to produce an optical density from one (1) to two (2) when processed shall not suffer an increase in density greater than one-tenth (0.1) (five one-hundredths [0.05] for mammography) when exposed in the darkroom for two (2) minutes with all safelights on. If used, daylight film handling boxes shall preclude fogging of the film.
7.3.b.2.C. Darkrooms typically used by more than one individual shall be provided a method to prevent accidental entry while undeveloped films are being handled or processed.
7.3.b.2.D. Film shall be stored in a cool, dry place and shall be protected from exposure to stray radiation. Film in open packages shall be stored in a light tight container.
7.3.b.2.E. Film cassettes and intensifying screens shall be inspected periodically and shall be cleaned and replaced as necessary to best assure radiographs of good diagnostic quality.
7.3.b.2.F. Outdated x-ray film shall not be used for diagnostic radiographs, unless the film has been stored in accordance with the manufacturer's recommendations and a sample of the film passes a sensitometric test for normal ranges of base plus fog and speed.
7.3.b.2.G. Film developing solutions shall be prepared in accordance with the directions given by the manufacturer, and shall be maintained in strength by replenishment or renewal so that full development is accomplished within the time specified by the manufacturer.
7.4. Shielding Plan Review.
7.4.a. Prior to construction, the floor plans, shielding specifications and equipment arrangement of all new installations, or modifications of existing installations, utilizing ionizing radiation machines shall be submitted to the agency for review and approval. The required information is denoted in Tables 64-23 Q and R.
7.4.b. The agency may require the applicant to utilize the services of a qualified expert to determine the shielding requirements prior to the plan review and approval.
7.4.c. The approval of such plans shall not preclude the requirement of additional modifications should a subsequent analysis of operating conditions indicate the possibility of an individual receiving a dose in excess of the limits prescribed in Subsections 6.5., 6.9. - 6.12., 6.13. and 6.14. of this rule.
7.4.d. After installation of a radiation machine, the registrant shall maintain for inspection by the agency:
7.4.d.1. The maximum rated technique factors of each machine;
7.4.d.2. A scale drawing of the room in which a stationary radiation machine system is located with such drawing indicating the use of areas adjacent to the room and an estimation of the extent of occupancy by an individual in such areas. In addition, the drawing shall include:
7.4.d.2.A. The results of a survey for radiation levels present at the operator's position and at pertinent points outside the room at specified test conditions; or
7.4.d.2.B. The Type And thickness of materials, or lead equivalency, of each protective barrier.
7.5. Prohibited Use - No registrant shall operate or permit the operation of x-ray equipment unless the equipment and installation meet the applicable requirements of this rule.
7.6. General Requirements for All Diagnostic X-Ray Systems. In addition to other requirements of this Section, all diagnostic x-ray systems shall meet the following requirements:
7.6.a. Warning Label. The control panel containing the main power switch shall bear the warning statement, legible and accessible to view: "WARNING: This x-ray unit may be dangerous to patient and operator unless safe exposure factors and operating instructions are observed."
7.6.b. Battery Charge Indicator. On battery-powered x-ray generators, visual means shall be provided on the control panel to indicate whether the battery is in a state of charge adequate for proper operation.
7.6.c. Leakage Radiation from the Diagnostic Source Assembly. The leakage radiation from the diagnostic source assembly measured at a distance of 1 meter in any direction from the source shall not exceed twenty five and eight-tenths (25.8) C/kg (one hundred [100 milliroentgens] in one (1) hour when the x-ray tube is operated at its leakage technique factors. Compliance shall be determined by measurements averaged over an area of one hundred (100) square centimeters with no linear dimension greater than twenty (20) centimeters.
7.6.d. Radiation from Components Other Than the Diagnostic Source Assembly. The radiation emitted by a component other than the diagnostic source assembly shall not exceed five-tenths (0.5) C/kg (two [2] milliroentgens) in one (1) hour at five (5) centimeters from any accessible surface of the component when it is operated in an assembled x-ray system under any conditions for which it was designed. Compliance shall be determined by measurements averaged over an area of one hundred (100) square centimeters with no linear dimension greater than twenty (20) centimeters.
7.6.e. Beam Quality.
7.6.e.1. Half-Value Layer.
7.6.e.1.A. The half-value layer of the useful beam for a given x-ray tube potential shall not be less than the values shown in Table 64-23 O. If it is necessary to determine such half-value layer at an x-ray tube potential which is not listed in Table I, linear interpolation or extrapolation may be made.
7.6.e.1.B. For capacitor energy storage equipment, compliance with the requirements of Paragraph 7.6.e.1. shall be determined with the system fully charged and a setting of ten (10) mAs for each exposure.
7.6.e.1.C. The required minimal half-value layer of the useful beam shall include the filtration contributed by all materials which are permanently between the source and the patient.
7.6.e.2. Filtration Controls. For x-ray systems which have variable kVp and variable filtration for the useful beam, a device shall link the kVp selector with the filter or filters and shall prevent an exposure unless the minimum amount of filtration necessary to produce the HVL required by Paragraph 7.6.e.1. is in the useful beam for the given kVp which has been selected.
7.6.f. Multiple Tubes. Where two or more radiographic tubes are controlled by one exposure switch, the tube or tubes which have been selected shall be clearly indicated prior to initiation of the exposure. This indication shall be both on the x-ray control panel and at or near the tube housing assembly which has been selected.
7.6.g. Mechanical Support of Tube Head. The tube housing assembly supports shall be adjusted such that the tube housing assembly will remain stable during an exposure unless tube housing movement is a designed function of the x-ray system.
7.6.h. Technique Indicators.
7.6.h.1. The technique factors to be used during an exposure shall be indicated before the exposure begins. If automatic exposure controls are used, the technique factors which are set prior to the exposure shall be indicated.
7.6.h.2. The requirement of Paragraph 7.6.h.1. may be met by permanent markings on equipment having fixed technique factors. Indication of technique factors shall be visible from the operator's position except in the case of spot films made by the fluoroscopist.
7.6.i. Maintaining Compliance. Diagnostic x-ray systems and their associated components used on humans and certified pursuant to the federal x-ray equipment performance standard (21 CFR Part 1020) shall be maintained in compliance with applicable requirements of that standard.
7.6.j. Locks. All position locking, holding, and centering devices on x-ray system components and systems shall function as intended.
7.7. Fluoroscopic X-Ray Systems. All fluoroscopic x-ray systems used shall be image intensified and meet the following requirements:
7.7.a. Limitation of Useful Beam.
7.7.a.1. Primary Barrier
7.7.a.1.A. The fluoroscopic imaging assembly shall be provided with a primary protective barrier which intercepts the entire cross Section of the useful beam at any SID.
7.7.a.1.B. The x-ray tube used for fluoroscopy shall not produce x-rays unless the barrier is in position to intercept the entire useful beam.
7.7.a.2. Fluoroscopic Beam Limitation.
7.7.a.2.A. For certified fluoroscopic systems with or without a spot film device, neither the length nor the width of the x-ray field in the plane of the image receptor shall exceed that of the visible area of the image receptor by more than three (3) percent of the SID. The sum of the excess length and the excess width shall be no greater than four (4) percent of the SID.
7.7.a.2.B. For uncertified fluoroscopic systems with a spot film device, the x-ray beam with the shutters fully opened (during fluoroscopy or spot filming) shall be no larger than the largest spot film size for which the device is designed. Measurements shall be made at the minimum SID available but at no less than twenty (20) centimeters Table top to the film plane distance.
7.7.a.2.C. For uncertified fluoroscopic systems without a spot film device, the requirements of Subparagraph 7.7.a.2.A. apply.
7.7.a.2.D. Other Requirements for Fluoroscopic Beam Limitation:
7.7.a.2.D.1. Means shall be provided to permit further limitation of the field. Beam-limiting devices manufactured after May 22, 1979, and incorporated in equipment with a variable SID or a visible area of greater than three hundred (300) square centimeters shall be provided with means for stepless adjustment of the x-ray field;
7.7.a.2.D.2. All equipment with a fixed SID and a visible area of three hundred (300) square centimeters or less shall be provided with either stepless adjustment of the x-ray field or with means to further limit the x-ray field size at the plane of the image receptor to one hundred twenty five (125) square centimeters or less;
7.7.a.2.D.3. If provided, stepless adjustment shall, at the greatest SID, provide continuous field sizes from the maximum attainable to a field size of five (5) centimeters by five (5) centimeters or less;
7.7.a.2.D.4. For equipment manufactured after February 25, 1978, when the angle between the image receptor and beam axis is variable, means shall be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor;
7.7.a.2.D.5. For non-circular x-ray fields used with circular image receptors, the error in alignment shall be determined along the length and width dimensions of the x-ray field which pass through the center of the visible area of the image receptor.
7.7.a.3. Spot-film Beam Limitation. Spot-film devices shall meet the following requirements:
7.7.a.3.A. Means shall be provided between the source and the patient for adjustment of the x-ray field size in the plane of the film to the size of that portion of the film which has been selected on the spot film selector. Such adjustment shall be automatically accomplished except when the x-ray field size in the plane of the film is smaller than that of the selected portion of the film. For spot film devices manufactured after June 21, 1979, if the x-ray field size is less than the size of the selected portion of the film, the means for adjustment of the field size shall be only at the operator's option;
7.7.a.3.B. Neither the length nor the width of the x-ray field in the plane of the image receptor shall differ from the corresponding dimensions of the selected portion of the image receptor by more than three (3) percent of the SID when adjusted for full coverage of the selected portion of the image receptor. The sum, without regard to sign, of the length and width differences shall not exceed four (4) percent of the SID;
7.7.a.3.C. It shall be possible to adjust the x-ray field size in the plane of the film to a size smaller than the selected portion of the film. The minimum field size at the greatest SID shall be equal to, or less than, five (5) centimeters by five (5) centimeters;
7.7.a.3.D. The center of the x-ray field in the plane of the film shall be aligned with the center of the selected portion of the film to within two (2) percent of the SID; and
7.7.a.3.E. On spot-film devices manufactured after February 25, 1978, if the angle between the plane of the image receptor and beam axis is variable, means shall be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor, and compliance shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor.
7.7.a.4. Override. If a means exists to override any of the automatic x-ray field size adjustments required in Paragraphs 7.7.a.2. and 3., that means:
7.7.a.4.A. Shall be designed for use only in the event of system failure;
7.7.a.4.B. Shall incorporate a signal visible at the fluoroscopist's position which will indicate whenever the automatic field size adjustment is overridden; and
7.7.a.4.C. Shall be clearly and durably labeled as follows:
FOR X-RAY FIELD
LIMITATION SYSTEM FAILURE
7.7.b. Activation of the Fluoroscopic Tube. X-ray production in the fluoroscopic mode shall be controlled by a device which requires continuous pressure by the fluoroscopist for the entire time of any exposure. When recording serial fluoroscopic images, the fluoroscopist shall be able to terminate the x-ray exposures at any time, but means may be provided to permit completion of any single exposure of the series in process.
7.7.c. Exposure Rate Limits.
7.7.c.1. Entrance Exposure Allowable Limits.
7.7.c.1.A. Fluoroscopic equipment which is provided with automatic exposure rate control shall not be operable at any combination of tube potential and current which will result in an exposure rate in excess of two and six-tenths (2.6) mC/kg (ten [10]Roentgens) per minute at the point where the center of the useful beam enters the patient, except:
7.7.c.1.A.1. During recording of fluoroscopic images; or
7.7.c.1.A.2. When an optional high level control is provided. When so provided, the equipment shall not be operable at any combination of tube potential and current which will result in an exposure rate in excess of one and three-tenths (1.3) mC/kg (five [5] Roentgens) per minute at the point where the center of the useful beam enters the patient unless the high level control is activated. Special means of activation of high level controls shall be required. The high level control shall only be operable when continuous manual activation is provided by the operator. A continuous signal audible to the fluoroscopist shall indicate that the high level control is being employed.
7.7.c.1.B. Fluoroscopic equipment which is not provided with automatic exposure rate control shall not be operable at any combination of tube potential and current which will result in an exposure rate in excess of one and three-tenths (1.3) mC/kg (five [5] Roentgens) per minute at the point where the center of the useful beam enters the patient, except:
7.7.c.1.B.1. During recording of fluoroscopic images; or
7.7.c.1.B.2. When an optional high level control is activated. Special means of activation of high level controls shall be required. The high level control shall only be operable when continuous manual activation is provided by the operator. A continuous signal audible to the fluoroscopist shall indicate that the high level control is being employed.
7.7.c.1.C. Compliance with the requirements of Subdivision 7.7.c. shall be determined as follows:
7.7.c.1.C.1. If the source is below the x-ray Table, the exposure rate shall be measured one (1) centimeter above the Tabletop or cradle;
7.7.c.1.C.2. If the source is above the x-ray Table, the exposure rate shall be measured at thirty (30) centimeters above the Tabletop with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement;
7.7.c.1.C.3. For a C-arm type of fluoroscope, the exposure rate shall be measured thirty (30) centimeters from the input surface of the fluoroscopic imaging assembly, with the source positioned at any available SID, provided that the end of the beam-limiting device or spacer is no closer than thirty (30) centimeters from the input surface of the fluoroscopic imaging assembly;
7.7.c.1.C.4. For a lateral type fluoroscope, the exposure rate shall be measured at a point fifteen (15) centimeters from the centerline of the x-ray Table and in the direction of the x-ray source with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement. If the Tabletop is movable, it shall be positioned as closely as possible to the lateral x-ray source, with the end of the beam-limiting device or spacer no closer than fifteen (15) centimeters to the centerline of the x-ray Table.
7.7.c.2. Periodic measurement of entrance exposure rate shall be performed by a qualified expert for both typical and maximum values as follows: 5
7.7.c.2.A. Such measurements shall be made annually or after any maintenance of the system which might affect the exposure rate;
7.7.c.2.B. Results of these measurements shall be posted where any fluoroscopist may have ready access to such results while using the fluoroscope and in the record required in Part 7.3.a.12. The measurement results shall be stated in coulombs per kilogram (Roentgens) per minute and include the technique factors used in determining such results. The name of the individual performing the measurements and the date the measurements were performed shall be included in the results;
7.7.c.2.C. Conditions of periodic measurement of typical entrance exposure rate are as follows:
7.7.c.2.C.1. The measurement shall be made under the conditions that satisfy the requirements of 7.7.c.2.C.2.;
7.7.c.2.C.2. The kVp, mA, and other selectable parameters shall be adjusted to those settings typical of clinical use on a twenty three (23) cm thick abdominal patient;
7.7.c.2.C.3. The x-ray system that incorporates automatic exposure rate control shall have sufficient attenuative material placed in the useful beam to produce a milliamperage or kilovoltage to satisfy the conditions of 7.7.c.2.C.2.;
7.7.c.2.D. Conditions of periodic measurement of maximum entrance exposure rate are as follows:
7.7.c.2.D.1. The measurement shall be made under the conditions that satisfy the requirements of 7.7.c.2.C.2.;
7.7.c.2.D.2. The kVp, mA or other selectable parameters shall be adjusted to those settings which give the maximum entrance exposure rate;
7.7.c.2.D.3. The x-ray systems that incorporates automatic exposure rate control shall have sufficient attentuative material placed in the useful beam to produce the maximum entrance exposure rate of the system.
7.7.d. Barrier Transmitted Radiation Rate Limits.
7.7.d.1. The exposure rate due to transmission through the primary protective barrier with the attenuation block in the useful beam, combined with radiation from the image intensifier, if provided, shall not exceed five-tenths (0.5) C/kg (two [2] milliroentgens) per hour at ten (10) centimeters from any accessible surface of the fluoroscopic imaging assembly beyond the plane of the image receptor for each mC/kg (Roentgen) per minute of entrance exposure rate.
7.7.d.2. Measuring Compliance of Barrier Transmission.
7.7.d.2.A. The exposure rate due to transmission through the primary protective barrier combined with radiation from the image intensifier shall be determined by measurements averaged over an area of one hundred (100) square centimeters with no linear dimension greater than twenty (20) centimeters.
7.7.d.2.B. If the source is below the Tabletop, the measurement shall be made with the input surface of the fluoroscopic imaging assembly positioned thirty (30) centimeters above the Tabletop.
7.7.d.2.C. If the source is above the Tabletop and the SID is variable, the measurement shall be made with the end of the beam-limiting device or spacer as close to the Tabletop as it can be placed, provided that it shall not be closer than thirty (30) centimeters.
7.7.d.2.E. Movable grids and compression devices shall be removed from the useful beam during the measurement.
7.7.e. Indication of Potential and Current. During fluoroscopy and cinefluorography the kV and the mA shall be continuously indicated.
7.7.f. Source-to-Skin Distance. The SSD shall not be less than:
7.7.f.1. Thirty-eight (38) centimeters on stationary fluoroscopic systems manufactured on or after August 1, 1974;
7.7.f.2. Thirty-five and five-tenths (35.5) centimeters on stationary fluoroscopic systems manufactured prior to August 1, 1974;
7.7.f.3. Thirty (30) centimeters on all mobile fluoroscopes; or
7.7.f.4. Twenty (20) centimeters for all mobile fluoroscopes when used for specific surgical applications.
7.7.g. Fluoroscopic Timer.
7.7.g.1. Means shall be provided to preset the cumulative on-time of the fluoroscopic x-ray tube. The maximum cumulative time of the timing device shall not exceed five (5) minutes without resetting.
7.7.g.2. A signal audible to the fluoroscopist shall indicate the completion of any preset cumulative on-time. Such signal shall continue to sound while x rays are produced until the timing device is reset.
7.7.h. Control of Scattered Radiation.
7.7.h.1. Fluoroscopic Table designs when combined with procedures utilized shall be such that no unprotected part of any staff or ancillary individual's body shall be exposed to unattenuated scattered radiation which originates from under the Table. The attenuation required shall be not less than twenty five one-hundredths (0.25) millimeter lead equivalent.
7.7.h.2. Equipment configuration when combined with procedures shall be such that no portion of any staff or ancillary individual's body, except the extremities, shall be exposed to the unattenuated scattered radiation emanating from above the Tabletop unless that individual:
7.7.h.2.A. Is at least one hundred twenty (120) centimeters from the center of the useful beam; or
7.7.h.2.B. The radiation has passed through not less than twenty five (0.25) millimeter lead equivalent material including, but not limited to, drapes, bucky-slot cover panel, or self-supporting curtains, in addition to any lead equivalency provided by the protective apron referred to in Paragraph 7.3.a.5.
7.7.h.3. The agency may grant exemptions to Subdivision 7.7.h.2. where a sterile field will not permit the use of the normal protective barriers. Where the use of prefitted sterilized covers for the barriers is practical, the agency shall not permit such exemption. See Table 64-23 S for a suggested list of fluoroscopic procedures where such exemptions will be automatically granted.
7.7.i. Spot Film Exposure Reproducibility. Fluoroscopic systems equipped with spot film (radiographic) mode shall meet the exposure reproducibility requirements of Subsection 7.8.d. when operating in the spot film mode.
7.7.j. Radiation Therapy Simulation Systems. Radiation therapy simulation systems shall be exempt from all the requirements of Subsection 7.7.c. In addition, these systems shall be exempt from:
7.7.j.1. The requirements of Subsections 7.7.a. and 7.7.d. provided such systems are designed and used in such a manner that no individual other than the patient is in the x-ray room during periods of time when the system is producing x-rays; and
7.7.j.2. The requirements of Subsection 7.7.g. if such systems are provided with a means of indicating the cumulative time that an individual patient has been exposed to x-rays. Procedures shall require in such cases that the timer be reset between examinations.
7.8. Radiographic Systems Other Than Fluoroscopic, Dental Intraoral, or Computed Tomography X-Ray Systems.
7.8.a. Beam Limitation, Except Mammographic Systems. The useful beam shall be limited to the area of clinical interest. This shall be deemed to have been met if a positive beam limiting device meeting manufacturer's specifications and the requirements of Paragraph 7.8.h.2. has been properly used or if evidence of collimation is shown on at least three sides or three corners of the film (for example, projections from the shutters of the collimator, cone cutting at the corners, or borders at the film's edge).
7.8.a.1. General Purpose Stationary and Mobile X-Ray Systems, Including Veterinary Systems (Other than Portable) Installed After the Effective Date of This rule.
7.8.a.1.A. Only x-ray systems provided with means for independent stepless adjustment of at least two dimensions of the x-ray field shall be used.
7.8.a.1.B. A method shall be provided for visually defining the perimeter of the x-ray field. The total misalignment of the edges of the visually defined field with the respective edges of the x-ray field along either the length or width of the visually defined field shall not exceed two (2) percent of the distance from the source to the center of the visually defined field when the surface upon which it appears is perpendicular to the axis of the x-ray beam.
7.8.a.1.C. The agency may grant an exemption on non-certified x-ray systems to Subparagraphs 7.8.a.1.A. and B. provided the registrant makes a written application for such exemption and in that application:
7.8.a.1.C.1. Demonstrates it is impractical to comply with Subparagraphs 7.8.a.1.A. and B.; and
7.8.a.1.C.2. The purpose of Subparagraphs 7.8.a.1.A. and B. will be met by other methods.
7.8.a.2. Additional Requirements for Stationary General Purpose X-Ray Systems. In addition to the requirements of Paragraph 7.8.a.1., stationary general purpose x-ray systems, both certified and noncertified, shall meet the following requirements:
7.8.a.2.A. A method shall be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor, to align the center of the x-ray field with respect to the center of the image receptor to within two (2) percent of the SID, and to indicate the SID to within two (2) percent;
7.8.a.2.B. The beam-limiting device shall indicate numerically the field size in the plane of the image receptor to which it is adjusted; and
7.8.a.2.C. Indication of field size dimensions and SIDs shall be specified in inches or centimeters, and shall be such that aperture adjustments result in x-ray field dimensions in the plane of the image receptor which correspond to those indicated by the beam-limiting device to within two (2) percent of the SID when the beam axis is indicated to be perpendicular to the plane of the image receptor.
7.8.a.3. X-Ray Systems Designed for One Image Receptor Size. Radiographic equipment designed for only one image receptor size at a fixed SID shall be provided with means to limit the field at the plane of the image receptor to dimensions no greater than those of the image receptor, and to align the center of the x-ray field with the center of the image receptor to within two (2) percent of the SID, or shall be provided with means to both size and align the x-ray field such that the x-ray field at the plane of the image receptor does not extend beyond any edge of the image receptor.
7.8.a.4. X-Ray Systems Other Than Those Described in Subparagraphs 7.8.a.1.A., B. and C. and Veterinary Systems Installed Prior to the Effective Date of This rule and all Portable Veterinary X-Ray Systems.
7.8.a.4.A. Means shall be provided to limit the x-ray field in the plane of the image receptor so that such field does not exceed each dimension of the image receptor by more than two (2) percent of the SID when the axis of the x-ray beam is perpendicular to the plane of the image receptor.
7.8.a.4.B. Means shall be provided to align the center of the x-ray field with the center of the image receptor to within two (2) percent of the SID, or means shall be provided to both size and align the x-ray field such that the x-ray field at the plane of the image receptor does not extend beyond any edge of the image receptor. Compliance shall be determined with the axis of the x-ray beam perpendicular to the plane of the image receptor.
7.8.a.4.C. Subparagraph 7.8.a.4.A and B. may be met with a system that meets the requirements for a general purpose x-ray system as specified in Paragraph 7.8.a.1. or, when alignment means are also provided, may be met with either:
7.8.a.4.C.1. An assortment of removable, fixed-aperture, beam-limiting devices sufficient to meet the requirement for each combination of image receptor size and SID for which the unit is designed with each such device having clear and permanent markings to indicate the image receptor size and SID for which it is designed; or
7.8.a.4.C.2. A beam-limiting device having multiple fixed apertures sufficient to meet the requirement for each combination of image receptor size and SID for which the unit is designed. Permanent, clearly legible markings shall indicate the image receptor size and SID for which each aperture is designed and shall indicate which aperture is in position for use.
7.8.b. Radiation Exposure Control.
7.8.b.1. Exposure Initiation. Means shall be provided to initiate the radiation exposure by a deliberate action on the part of the operator, such as the depression of a switch. Radiation exposure shall not be initiated without such an action. In addition, it shall not be possible to initiate an exposure when the timer is set to a "zero" or "off" position if either position is provided.
7.8.b.2. Exposure Indication. Means shall be provided for visual indication observable at or from the operator's protected position whenever x-rays are produced. In addition, a signal audible to the operator shall indicate that the exposure has terminated.
7.8.b.3. Exposure Termination. Means shall be provided to terminate the exposure at a preset time interval, preset product of current and time, a preset number of pulses, or a preset radiation exposure to the image receptor. Except for dental panoramic systems, termination of an exposure shall cause automatic resetting of the timer to its initial setting or to "zero."
7.8.b.3.A. Manual Exposure Control. An x-ray control shall be incorporated into each x-ray system such that an exposure can be terminated by the operator at any time except for:
7.8.b.3.A.1. Exposure of one-half (½) second or less; or
7.8.b.3.A.2. During serial radiography when means shall be provided to permit completion of any single exposure of the series in process.
7.8.b.3.B. Automatic Exposure Controls. When an automatic exposure control is provided:
7.8.b.3.B.1. Indication shall be made on the control panel when this mode of operation is selected;
7.8.b.3.B.2. If the x-ray tube potential is equal to or greater than fifty (50) kVp, the minimum exposure time for field emission equipment rated for pulsed operation shall be equal to or less than a time interval equivalent to two (2) pulses;
7.8.b.3.B.3. The minimum exposure time for all equipment other than that specified in Part 7.8.b.3.B.2. shall be equal to or less than one-sixtieth (1/60) second or a time interval required to deliver five (5) mAs, whichever is greater;
7.8.b.3.B.4. Either the product of peak x-ray tube potential, current, and exposure time shall be limited to not more than sixty (60) kWs per exposure, or the product of x-ray tube current and exposure time shall be limited to not more than six hundred (600) mAs per exposure except that, when the x-ray tube potential is less than fifty (50) kVp, the product of x-ray tube current and exposure time shall be limited to not more than two thousand (2000) mAs per exposure; and
7.8.b.3.B.5. A visible signal shall indicate when an exposure has been terminated at the limits required by Part 7.8.b.3.B.4., and manual resetting shall be required before further automatically timed exposures can be made.
7.8.b.4. Exposure Duration (Timer) Linearity. For systems having independent selection of exposure time settings, the average ratios (Xi) of exposure to the indicated timer setting, in units of C kg-1s-1 (mR/s), obtained at any two clinically used timer settings shall not differ by more than one-tenth (0.10) times their sum. This is written as:
(X1 - X2) 0.1 (X1 + X2) where X1 and X2 are the average C kg-1s-1 (mR/s) values.
7.8.b.5. Exposure Control Location. The x-ray exposure control shall be so placed that the operator can view the patient while making any exposure.
7.8.b.6. Operator Protection, Except Veterinary Systems.
7.8.b.6.A. Stationary Systems. Stationary x-ray systems shall be required to have the x-ray control permanently mounted in a protected area so that the operator is required to remain in that protected area during the entire exposure.
7.8.b.6.B. Mobile and Portable Systems. Mobile and portable x-ray systems which are:
7.8.b.6.B.1. Used continuously for greater than one week in the same location, i.e., a room or suite, shall meet the requirements of Subparagraph 7.8.b.6.A.;
7.8.b.6.B.2. Used for less than one week at the same location shall be provided with either a protective barrier at least two (2) meters six and one-half (six [6.5] feet) high for operator protection during exposures, or means shall be provided to allow the operator to be at least two and seven-tenths (2.7) meters (nine [9] feet) from the tube housing assembly during the exposure.
7.8.b.7. Operator Protection for Veterinary Systems. All stationary, mobile or portable x-ray systems used for veterinary work shall be provided with either a two (2) meter (six and one-half [6.5] feet) high protective barrier for operator protection during exposures, or shall be provided with means to allow the operator to be at least two and seven-tenths (2.7) meters (nine [9] feet) from the tube housing assembly during exposures.
7.8.c. Source-to-Skin Distance. All mobile or portable radiographic systems shall be provided with means to limit the source-to-skin distance to equal to or greater than thirty (30) centimeters, except for veterinary systems.
7.8.d. Exposure Reproducibility. When all technique factors are held constant, including control panel selections associated with automatic exposure control systems, the coefficient of variation of exposure for both manual and automatic exposure control systems shall not exceed five one-hundredths (0.05). This requirement applies to clinically used techniques.
7.8.e. Radiation from Capacitor Energy Storage Equipment in Standby Status. Radiation emitted from the x-ray tube when the system is fully charged and the exposure switch or timer is not activated shall not exceed a rate of five-tenths (0.5) C/kg (two [2] milliroentgens) per hour at five (5) centimeters from any accessible surface of the diagnostic source assembly, with the beam-limiting device fully open.
7.8.f. Accuracy. Deviation of measured technique factors from indicated values of kVp and exposure time shall not exceed the limits specified for that system by its manufacturer. In the absence of manufacturer's specifications, the deviation shall not exceed ten (10) percent of the indicated value for kVp and [20] percent for time.
7.8.g. mA/mAs Linearity. The following requirements apply when the equipment is operated on a power supply as specified by the manufacturer for any fixed x-ray tube potential within the range of forty (40) percent to one hundred (100) percent of the maximum rated:
7.8.g.1. Equipment Having Independent Selection of X-Ray Tube Current (mA). The average ratios (Xi) of exposure to the indicated milliampere-seconds product C kg-1 mAs-1 (or mR/mAs) obtained at any two consecutive tube current settings shall not differ by more than one-tenth (0.10) times their sum:
X1-X2 < 0.10 (X1+X2) where X1 and X2 are the average values obtained at each of two consecutive tube current settings, or at two settings differing by no more than a factor of two (2) where the tube current selection is continuous.
7.8.g.2. Equipment Having a Combined X-Ray Tube Current-Exposure Time Product (mAs) Selector, But Not a Separate Tube Current (mA) Selector. The average ratios (Xi) of exposure to the indicated milliampere-seconds product, in units of C kg-1 mAs-1 (or mR/mAs), obtained at any two consecutive mAs selector settings shall not differ by more than one-tenth (0.10) times their sum:
X1-X2 < 0.10 (X1 +X2) where X1 and X2 are the average values obtained at any two mAs selector settings, or at two settings differing by no more than a factor of two (2) where the mAs selector provides continuous selection.
7.8.g.3. Measuring Compliance. Determination of compliance shall be based on ten (10) exposures taken within a time period of one hour, at each of the two settings. These two settings may include any two focal spot sizes except where one is equal to or less than forty five one-hundredths (0.45) millimeters and the other is greater than forty five one-hundredths (0.45) millimeters. For purposes of this requirement, focal spot size is the nominal focal spot size specified by the x-ray tube manufacturer.
7.8.h. Additional Requirements Applicable to Certified Systems Only. Diagnostic x-ray systems incorporating one or more certified component or components shall be required to comply with the following additional require mentor requirements which relate to that certified component or components.
7.8.h.1. Beam Limitation for Stationary and Mobile General Purpose X-Ray Systems.
7.8.h.1.A. There shall be provided a means of stepless adjustment of the size of the x-ray field. The minimum field size at an SID of one hundred (100) centimeters shall be equal to or less than five (5) centimeters by five (5) centimeters.
7.8.h.1.B. When a light localizer is used to define the x-ray field, it shall provide an average illumination of not less than one hundred sixty (160) lux or fifteen (15) footcandles at one hundred (100) centimeters or at the maximum SID, whichever is less. The average illumination shall be based upon measurements made in the approximate center of each quadrant of the light field. Radiation therapy simulation systems manufactured on and after May 27, 1980, are exempt from this requirement.
7.8.h.1.C. The edge of the light field at one hundred (100) centimeters or at the maximum SID, whichever is less, shall have a contrast ratio, corrected for ambient lighting, of not less than four (4) in the case of beam-limiting devices designed for use on stationary equipment, and a contrast ratio of not less than three (3) in the case of beam-limiting devices designed for use on mobile equipment. The contrast ratio is defined as I1/I2 where I1 is the illumination three (3) millimeters from the edge of the light field toward the center of the field; and I2 is the illumination three (3) millimeters from the edge of the light field away from the center of the field. Compliance shall be determined with a measuring instrument aperture of one (1) millimeter in diameter.
7.8.h.2. Beam Limitation and Alignment on Stationary General Purpose X-Ray Systems Equipped with PBL. If PBL is being used, the following requirements shall be met:
7.8.h.2.A. PBL shall prevent the production of x-rays when:
7.8.h.2.A.1. Either the length or width of the x-ray field in the plane of the image receptor differs, except as permitted by Subparagraph 7.8.h.2.C., from the corresponding image receptor dimensions by more than three (3) percent of the SID; or
7.8.h.2.A.2. The sum of the length and width differences as stated in Part 7.8.h.2.A.1. without regard to sign exceeds four (4) percent of the SID;
7.8.h.2.B. Compliance with Subparagraph 7.8.h.2.A. shall be determined when the equipment indicates that the beam axis is perpendicular to the plane of the image receptor. Compliance shall be determined no sooner than five (5) seconds after insertion of the image receptor;
7.8.h.2.C. The PBL system shall be capable of operation, at the discretion of the operator, such that the size of the field may be made smaller than the size of the image receptor through stepless adjustment of the field size. The minimum field size at an SID of one hundred (100) centimeters shall be equal to or less than five (5) centimeters by five (5) centimeters;
7.8.h.2.D. The PBL system shall be designed such that if a change in image receptor does not cause an automatic return to PBL function as described in Subparagraph 7.8.h.2.A., then any change of image receptor size or SID must cause the automatic return.
7.8.h.3. Beam Limitation for Portable X-Ray Systems. Beam limitation for portable x-ray systems shall meet the beam limitation requirements of Paragraphs 7.8.a.1. or 7.8.h.2.
7.8.i. Tube Stands for Portable X-Ray Systems. A tube stand or other mechanical support shall be used for portable x-ray systems, so that the x-ray tube housing assembly need not be hand-held during exposures.
7.9. Intraoral Dental Radiographic Systems. In addition to the provisions of Subsections 7.3 and 7.4. the requirements of Subsection 7.9. apply to x-ray equipment and associated facilities used for dental radiography. Requirements for extraoral dental radiographic systems are covered in Subsection 7.8. Only systems meeting the requirements of Subsection 7.9. shall be used.
7.9.a. Source-to-Skin Distance (SSD). X-ray systems designed for use with an intraoral image receptor shall be provided with means to limit SSD, to not less than:
7.9.a.1. Eighteen (18) centimeters if operable above fifty (50) kVp; or
7.9.a.2. Ten (10) centimeters if operable at fifty (50) kVp only.
7.9.b. Beam Limitation. Radiographic systems designed for use with an intraoral image receptor shall be provided with means to limit the x-ray beam such that the beam at the minimum SSD shall be containable in a circle having a diameter of no more than seven (7) centimeters.
7.9.c. Radiation Exposure Control.
7.9.c.1. Exposure Initiation.
7.9.c.1.A. Means shall be provided to initiate the radiation exposure by a deliberate action on the part of the operator, such as the depression of a switch. Radiation exposure shall not be initiated without such an action; and
7.9.c.1.B. It shall not be possible to make an exposure when the timer is set to a "zero" or "off" position if either position is provided.
7.9.c.2. Exposure Indication. Means shall be provided for visual indication observable at or from the operator's protected position whenever x-rays are produced. In addition, a signal audible to the operator shall indicate that the exposure has terminated.
7.9.c.3. Exposure Termination.
7.9.c.3.A. Means shall be provided to terminate the exposure at a preset time interval, preset product of current and time, a preset number of pulses, or a preset radiation exposure to the image receptor.
7.9.c.3.B. An x-ray exposure control shall be incorporated into each x-ray system such that an exposure can be terminated by the operator at any time, except for exposures of one-half (½) second or less.
7.9.c.3.C. Termination of an exposure shall cause automatic resetting of the timer to its initial setting or to "zero."
7.9.c.4. Exposure Duration (Timer) Linearity. For systems having independent selection of exposure time settings, the average ratios (Xi) of exposure to the indicated timer setting, in units of C kg-1 s-1 (mR/s), obtained at any two clinically used timer settings shall not differ by more than one-tenth (0.10) times their sum. This is written as:
(X1 - X2) 0.1 (X1 + X2) where X1 and X2 are the average values.
7.9.c.5. Exposure Control Location and Operator Protection.
7.9.c.5.A. Stationary x-ray systems installed after the effective date of this rule shall be required to have the x-ray exposure control permanently mounted in a protected area, so that the operator is required to remain in that protected area during the entire exposure; and
7.9.c.5.B. Mobile and portable x-ray systems which are:
7.9.c.5.B.1. Used for greater than one week in the same location, i.e., a room or suite, shall meet the requirements of Subparagraph 7.9.c.5.a.;
7.9.c.5.B.2. Used for less than one week in the same location shall be provided with either a protective barrier at least two (2) meters (six and five-tenths [6.5] feet) high for operator protection, or means to allow the operator to be at least two and seven-tenths (2.7) meters (nine [9] feet) from the tube housing assembly while making exposures.
7.9.d. Reproducibility. When the equipment is operated on an adequate power supply as specified by the manufacturer, the estimated coefficient of variation of radiation exposures shall be no greater than five one-hundredths (0.05), for any specific combination of selected technique factors.
7.9.e. mA/mAs Linearity. The following requirements apply when the equipment is operated on a power supply as specified by the manufacturer for any fixed x-ray tube potential within the range of forty (40) percent to one hundred (100) percent of the maximum rated.
7.9.e.1. Equipment Having Independent Selection of X-Ray Tube Current (mA). The average ratios (Xi) of exposure to the indicated milliampere-seconds product, in units of C kg-1 mAs-1 (or mR/mAs), obtained at any two consecutive tube current settings shall not differ by more than one-tenth (0.10) times their sum:
X1 - X2 < 0.10 (X1+X2) where X1 and X2 are the average values obtained at each of two consecutive tube current settings, or at two settings differing by no more than a factor of two (2) where the tube current selection is continuous.
7.9.e.2. Equipment Having a Combined X-Ray Tube Current-Exposure Time Product (mAs) Selector, But Not a Separate Tube Current (mA) Selector. The average ratios (Xi) of exposure to the indicated milliampere-seconds product, in units of C kg-1 mAs-1 (or mR/mAs), obtained at any two consecutive mAs selector settings shall not differ by more than one-tenth (0.10) times their sum:
X1 - X2 < 0.10 (X1 +X2) where X1 and X2 are the average values obtained at any two mAs selector settings, or at two settings differing by no more than a factor of two (2) where the mAs selector provides continuous selection.
7.9.e.3. Measuring Compliance. Determination of compliance shall be based on ten (10) exposures taken within a time period of one hour, at each of the two settings. These two settings may include any two focal spot sizes except where one is equal to or less than forty five one-hundredths (0.45) millimeters and the other is greater than forty five 0ne-hundredths (0.45) millimeters. For purposes of this requirement, focal spot size is the nominal focal spot size specified by the x-ray tube manufacturer.
7.9.f. Accuracy. Deviation of technique factors from indicated values for kVp and exposure time (if time is independently selectable) shall not exceed the limits specified for that system by its manufacturer. In the absence of manufacturer's specifications the deviation shall not exceed ten (10) percent of the indicated value for kVp and twenty (20) percent for time.
7.9.g. kVp Limitations. Dental x-ray machines with a nominal fixed kVp of less than fifty (50) kVp shall not be used to make diagnostic dental radiographs of humans.
7.9.h. Administrative Controls.
7.9.h.1. Patient and film holding devices shall be used when the techniques permit.
7.9.h.2. The tube housing and PID shall not be hand-held during an exposure.
7.9.h.3. The x-ray system shall be operated in such a manner that the useful beam at the patient’s skin does not exceed the requirements of Paragraph 7.9.2.
7.9.h.4. Fluoroscopy without image intensification shall not be used in dental examinations.
7.9.h.5. The tube head shall remain stationary when placed in the exposure position.
7.10. Computed Tomography X-Ray Systems.
7.10.a. Definitions. In addition to the definitions provided in Section 3. and Subsection 7.2. of this rule, the following definitions shall be applicable to Subsection 7.10.:
7.10.a.1. Computed Tomography Dose Index - the integral from -7T to +7T of the dose profile along a line perpendicular to the tomographic plane divided by the product of the nominal tomographic Section thickness and the number of tomograms produced in a single scan, that is: z = Position along a line perpendicular to the tomographic plane;
D(z) = Dose at position z;
T = Nominal tomographic Section thickness; n = Number of tomograms produced in a single scan.
This definition assumes that the dose profile is centered around z=0 and that, for a multiple tomogram system, the scan increment between adjacent scans is nT.
7.10.a.2. Contrast Scale - the change in the linear attenuation coefficient per ctn relative to water, that is: mu SUB FUNC x = Linear attenuation coefficient of the material of interest; mu SUB FUNC w = Linear attenuation coefficient of water; { FUNC OVERLINE CTN } SUB FUNC x = of the material of interest; { FUNC OVERLINE CTN } SUB FUNC w = of water.
7.10.a.3. CS - Contrast Scale.
7.10.a.4. CT Conditions of Operation - all selectable parameters governing the operation of a CT x-ray system including, but not limited to, nominal tomographic Section thickness, filtration, and the technique factors as defined in Subsection 7.2.
7.10.a.5. CTDI - Computed Tomography Dose ID Index.
7.10.a.6. CT Gantry - the tube housing assemblies, beam-limiting devices, detectors, and the supporting structures and frames which hold these components.
7.10.a.7. CTN - CT Number.
7.10.a.8. CT Number - the number used to represent the x-ray attenuation associated with each elemental area of the CT image.
FUNC k = A constant, a normal value of one thousand (1,000) when the Houndsfield scale of ctn is used; mu SUB FUNC x = Linear attenuation coefficient of the material of interest; mu SUB FUNC w = Linear attenuation coefficient of water.
7.10.a.9. Dose Profile - the dose as a function of position along a line.
7.10.a.10. Elemental Area - he smallest area within a tomogram for which the x-ray attenuation properties of a body are depicted.
7.10.a.11. Multiple Tomogram System - a computed tomography x-ray system which obtains x-ray transmission data simultaneously during a single scan to produce more than one tomogram.
7.10.a.12. Noise - the standard deviation of the fluctuations in CTN expressed as a percentage of the attenuation coefficient of water. Its estimate (Sn) is calculated using the following expression:
FUNC OVERLINE { CS } = Linear attenuation coefficient of the material of interest. mu SUB FUNC w = Linear attenuation coefficient of water.
FUNC s = Standard deviation of the CTN of picture elements in a specified area of the CT image.
7.10.a.13. Nominal Tomographic Section Thickness - the full width at half-maximum of the sensitivity profile taken at the center of the cross-sectional volume over which x-ray transmission data are collected.
7.10.a.14. Picture Element - an elemental area of a tomogram.
7.10.a.15. Reference Plane - a plane which is displaced from and parallel to the tomographic plane.
7.10.a.16. Scan - the complete process of collecting x-ray transmission data for the production of a tomogram. Data can be collected simultaneously during a single scan for the production of one or more tomograms.
7.10.a.17. Scan Increment - the amount of relative displacement of the patient with respect to the CT x-ray system between successive scans measured along the direction of such displacement.
7.10.a.18. Scan Sequence - a pre-selected set of two or more scans performed consecutively under pre-selected CT conditions of operation.
7.10.a.19. Scan Time - the period of time between the beginning and end of x-ray transmission data accumulation for a single scan.
7.10.a.20. Single Tomogram System - a CT x-ray system which obtains x-ray transmission data during a scan to produce a single tomogram..
7.10.a.21. Tomographic Plane - that geometric plane which is identified as corresponding to the output tomogram.
7.10.a.22. Tomographic Section - the volume of an object whose x-ray attenuation properties are imaged in a tomogram.
7.10.b. Requirements for Equipment.
7.10.b.1. Termination of Exposure.
7.10.b.1.A. Means shall be provided to terminate the x-ray exposure automatically by either de-energizing the x-ray source or shuttering the x-ray beam in the event of equipment failure affecting data collection. Such termination shall occur within an interval that limits the total scan time to no more than one hundred ten (110) percent of its preset value through the use of either a backup timer or devices which monitor equipment function.
7.10.b.1.B. A visible signal shall indicate when the x-ray exposure has been terminated through the means required by Subparagraph 7.10.b.1.A.
7.10.b.1.C. The operator shall be able to terminate the x-ray exposure at any time during a scan, or series of scans under CT x-ray system control, of greater than one-half (½) second duration.
7.10.b.2. Tomographic Plane Indication and Alignment.
7.10.b.2.A. For any single tomogram system, means shall be provided to permit visual determination of the tomographic plane or a reference plane offset from the tomographic plane.
7.10.b.2.B. For any multiple tomogram system, means shall be provided to permit visual determination of the location of a reference plane. This reference plane can be offset from the location of the tomographic planes.
7.10.b.2.C. If a device using a light source is used to satisfy the requirements of Subparagraphs 7.10.b.2.A. or B., the light source shall provide illumination levels sufficient to permit visual determination of the location of the tomographic plane or reference plane under ambient light conditions of up to five hundred (500) lux.
7.10.b.3. Beam-On and Shutter Status Indicators and Control Switches.
7.10.b.3.A. The CT x-ray control and gantry shall provide visual indication whenever x-rays are produced and, if applicable, whether the shutter is open or closed.
7.10.b.3.B. Each emergency button or switch shall be clearly labeled as to its function.
7.10.b.4. Indication of CT Conditions of Operation. The CT x-ray system shall be designed such that the CT conditions of operation to be used during a scan or a scan sequence shall be indicated prior to the initiation of a scan or a scan sequence. On equipment having all or some of these conditions of operation at fixed values, this requirement may be met by permanent markings. Indication of CT conditions of operation shall be visible from any position from which scan initiation is possible.
7.10.b.5. Extraneous Radiation. When data are not being collected for image production, the radiation adjacent to the tube port shall not exceed that permitted by Subdivision 7.6.c.
7.10.b.6. Maximum Surface CTDI Identification. The angular position where the maximum surface CTDI occurs shall be identified to allow for reproducible positioning of a CT dosimetry phantom.
7.10.b.7. Additional Requirements Applicable to CT X-Ray Systems Containing a Gantry Manufactured After September 3, 1985.
7.10.b.7.A. The total error in the indicated location of the tomographic plane or reference plane shall not exceed five (5) millimeters.
7.10.b.7.B. If the x-ray production period is less than one-half second, the indication of x-ray production shall be accurate for at least one-half (1/2) second. Indicators at or near the gantry shall be discernible from any point external to the patient opening where insertion of the human body into the primary beam is possible.
7.10.b.7.C. The deviation of indicated scan increment versus actual increment shall not exceed plus or minus one (1) millimeter with any mass from zero (0) to one hundred (100) kilograms resting on the support device. The patient support device shall be incremented from a typical starting position to the maximum incremented distance or thirty (30) centimeters, whichever is less, and then returned to the starting position. Measurement of actual versus indicated scan increment may be taken anywhere along this travel.
7.10.b.7.D. Premature termination of the x-ray exposure by the operator shall necessitate resetting of the CT conditions of operation prior to the initiation of another scan.
7.10.c. Facility Design Requirements.
7.10.c.1. Aural Communication. Provision shall be made for two-way aural communication between the patient and the operator at the control panel.
7.10.c.2. Viewing Systems.
7.10.c.2.A. Windows, mirrors, closed-circuit television, or an equivalent shall be provided to permit continuous observation of the patient during irradiation and shall be so located that the operator can observe the patient from the control panel.
7.10.c.2.B. When the primary viewing system is by electronic means, an alternate viewing system (which may be electronic) shall be available for use in the event of failure of the primary viewing system.
7.10.d. Surveys, Calibrations, Spot Checks, and Operating Procedures.
7.10.d.1. Surveys.
7.10.d.1.A. All CT x-ray systems installed after July 1, 2000 and those systems not previously surveyed shall have a survey made by, or under the direction of, a qualified expert. In addition, such surveys shall be done after any change in the facility or equipment which might cause a significant increase in radiation hazard.
7.10.d.1.B. The registrant shall obtain a written report of the survey from the qualified expert, and a copy of the report shall be made available to the agency upon request.
7.10.d.2. Radiation Calibrations.
7.10.d.2.A. The calibration of the radiation output of the CT x-ray system shall be performed by, or under the direction of, a qualified expert who is physically present at the facility during such calibration.
7.10.d.2.B. The calibration of a CT x-ray system shall be performed at intervals specified by a qualified expert and after any change or replacement of components which, in the opinion of the qualified expert, could cause a change in the radiation output.
7.10.d.2.C. The calibration of the radiation output of a CT x-ray system shall be performed with a calibrated dosimetry system. The calibration of such system shall be traceable to a national standard. The dosimetry system shall have been calibrated within the preceding two (2) years.
7.10.d.2.D. CT dosimetry phantoms shall be used in determining the radiation output of a CT x-ray system. Such phantoms shall meet the following specifications and conditions of use:
7.10.d.2.D.1. CT dosimetry phantoms shall be right circular cylinders of polymethyl methacrylate of density one and nineteen one-hundredths (1.19) plus or minus one one-hundredth (0.01) grams per cubic centimeter. The phantoms shall be at least fourteen (14) centimeters in length and shall have diameters of thirty two (32.0) centimeters for testing CT x-ray systems designed to image any Section of the body and sixteen (16.0) centimeters for systems designed to image the head or for whole body scanners operated in the head scanning mode;
7.10.d.2.D.2. CT dosimetry phantoms shall provide means for the placement of a dosimeter or dosimeters along the axis of rotation and along a line parallel to the axis of rotation one (1.0) centimeter from the outer surface and within the phantom. Means for the placement of dosimeters or alignment devices at other locations may be provided;
7.10.d.2.D.3. Any effects on the doses measured due to the removal of phantom material to accommodate dosimeters shall be accounted for through appropriate corrections to the reported data or included in the statement of maximum deviation for the values obtained using the phantom;
7.10.d.2.D.4. All dose measurements shall be performed with the CT dosimetry phantom placed on the patient couch or support device without additional attenuation materials present.
7.10.d.2.E. The calibration shall be required for each type of head, body, or whole-body scan performed at the facility.
7.10.d.2.F. Calibration shall meet the following requirements:
7.10.d.2.F.1. The dose profile along the center axis of the CT dosimetry phantom for the minimum, maximum, and midrange values of the nominal tomographic Section thickness used by the registrant shall be measurable. Where less than three (3) nominal tomographic thicknesses can be selected, the dose profile determination shall be performed for each available nominal tomographic Section thickness;
7.10.d.2.F.2. The CTDI6 along the two axes specified in Part 7.10.d.2.D.2. shall be measured. The CT dosimetry phantom shall be oriented so that the measurement point one (1.0) centimeter from the outer surface and within the phantom is in the same angular position within the gantry as the point of maximum surface CTDI identified. The CT conditions of operation shall correspond to typical values used by the registrant;
7.10.d.2.F.3. The spot checks specified in Paragraph 7.10.d.3. shall be made.
7.10.d.2.G. Calibration procedures shall be in writing. Records of calibrations performed shall be maintained for inspection by the agency.
7.10.d.3. Spot Checks.
7.10.d.3.A. The spot-check procedures shall be in writing and shall have been developed by a qualified expert.
7.10.d.3.B. The spot-check procedures shall incorporate the use of a CT dosimetry phantom which has a capability of providing an indication of contrast scale, noise, nominal tomographic Section thickness, the resolution capability of the system for low and high contrast objects, and measuring the mean CTN for water or other reference material.
7.10.d.3.C. All spot checks shall be included in the calibration required by Paragraph 7.10.d.2. and at time intervals and under system conditions specified by a qualified expert.
7.10.d.3.D. Spot checks shall include acquisition of images obtained with the CT dosimetry phantoms using the same processing mode and CT conditions of operation as are used to perform calibrations required by Paragraph 7.11.d.2. The images shall be retained, until a new calibration is performed, in two forms as follows:
7.10.d.3.D.1. Photographic copies of the images obtained from the image display device; and
7.10.d.3.D.2. Images stored in digital form on a storage medium compatible with the CT x-ray system.
7.10.d.3.E. Written records of the spot checks performed shall be maintained for inspection by the agency.
7.10.d.4. Operating Procedures.
7.10.d.4.A. The CT x-ray system shall not be operated except by an individual who has been specifically trained in its operation.
7.10.d.4.B. Information shall be available at the control panel regarding the operation and calibration of the system. Such information shall include the following:
7.10.d.4.B.1. Dates of the latest calibration and spot checks and the location within the facility where the results of those tests may be obtained;
7.10.d.4.B.2. Instructions on the use of the CT dosimetry phantoms including a schedule of spot checks appropriate for the system, allowable variations for the indicated parameters, and the results of at least the most recent spot checks conducted on the system;
7.10.d.4.B.3. The distance in millimeters between the tomographic plane and the reference plane if a reference plane is utilized; and
7.10.d.4.B.4. A current technique chart available at the control panel which specifies for each routine examination the CT conditions of operation and the number of scans per examination.
7.10.d.4.C. If the calibration or spot check of the CT x-ray system identifies that a system operating parameter has exceeded a tolerance established by the qualified expert, use of the CT x-ray system on patients shall be limited to those uses permitted by established written instructions of the qualified expert.
7.11. Mammography.
7.11.a. Equipment Standards. Only x-ray systems meeting the following standards shall be used.
7.11.a.1. System Design. The x-ray system shall be specifically designed for mammography.
7.11.a.2. Image Receptor. The image receptor systems and their individual components shall be specifically designed for or appropriate for mammography. Each screen-film mammography system must have, at a minimum, both an eighteen (18) by twenty four (24) cm and twenty four (24) by thirty (30) cm image receptor and moving grids matched to each image receptor size provided with the system.
7.11.a.3. kVp/Target/Filter. The x-ray system shall have the capability of providing kVp/target/filter combinations compatible with the selected image receptor system.
7.11.a.4. Beam Quality.
7.11.a.4.A. When used with screen-film image receptors, and when the contribution to filtration made by the compression device is included, the useful beam shall have a half-value layer (HVL):
7.11.a.4.A.1. Between the values of: [(measured kVp)/100] and [(measured kVp)/100 + 0.1] millimeters aluminum for molybdenum targets;
7.11.a.4.A.2. At least the value of [(measured kVp)/100] millimeters aluminum for rhodium alloy targets.
7.11.a.4.B. For xeroradiography, the HVL of the useful beam with the compression device in place shall be at least one (1.0) and not greater than one and six-tenths (1.6) mm aluminum, measured at forty nine (49) kVp with a tungsten target tube.
7.11.a.5. Resolution. The combination of focal spot size, source-to-image receptor distance and magnification shall result in a resolution of at least twelve (12) line pairs per millimeter (cycles/mm) measured when a resolution pattern is positioned four and two-tenths (4.2) cm above all breast supports and when the resolution pattern is either perpendicular to or parallel with the chest wall edge of the image receptor support. The measurement shall be made with the kVp in the range of twenty five to thirty (25-30) and the mA shall be the highest available for the focal spot size selected.
7.11.a.6. Compression.
7.11.a.6.A. The x-ray system shall be capable of compressing the breast with a force of at least twenty five (25) pounds and shall be capable of maintaining this compression for at least three (3) minutes. The maximum force shall be no greater than forty (40) pounds.
7.11.a.6.B. The chest wall edge of the compression paddle shall extend beyond the chest wall edge of the image receptor by no more than two (2) percent of the source-to-image receptor distance with the compression paddle placed four and two-tenths (4.2) cm above the breast support device. With the compression paddle in this position, the chest wall edge of the compression paddle shall not be visible in the acquired image.
7.11.a.7. System capabilities. A mammographic x-ray system utilizing screen-film image receptors shall have:
7.11.a.7.A. The capability of using anti-scatter grids which are:
7.11.a.7.A.1. Integral to the x-ray system;
7.11.a.7.A.2. Available for all image receptor sizes used;
7.11.a.7.B. The capability of automatic exposure control, for systems installed after the effective date of this rule; and
7.11.a.7.C. The capability of displaying post-exposure mAs after an exposure made using an automatic exposure control device, for systems installed after the effective date of this rule.
7.11.a.8. Milliampere-Second Read-Out Accuracy. For those mammographic x-ray systems equipped with automatic exposure control and post-exposure mAs read-out, the indicated mAs read-out shall be within ± ten (10) percent of the actual mAs delivered.
7.11.a.9. Transmission. For x-ray systems manufactured after September 5, 1978, the transmission of the primary beam through any image receptor support provided with the system shall be limited such that the exposure five (5) centimeters from any accessible surface beyond the plane of the image receptor supporting device does not exceed twenty five and eight-tenths (25.8) nC/kg (one-tenth [0.1] milliroentgen) for each activation of the tube. Exposure shall be measured with the system operated at the minimum SID for which it is designed. Compliance shall be determined at the maximum rated peak tube potential for the system and at the maximum rated product of tube current and exposure time (mAs) for that peak tube potential. Compliance shall be determined by measurements averaged over an area of one hundred (100) square centimeters with no linear dimension greater than twenty (20) centimeters.
7.11.a.10. Collimation.
7.11.a10.A. The mammographic system shall be provided with means to limit the useful beam such that the x-ray field at the plane of the image receptor does not extend beyond any edge of the image receptor at any designated SID except the edge of the image receptor designed to be adjacent to the chest wall where the x-ray field may not extend beyond this edge by more than two (2) percent of the SID.
7.11.a.10.B. Means for visually defining the perimeter of the x-ray field shall be provided. The total misalignment of the edges of the visually defined field with the respective edges of the x-ray field along either the length or width of the visually defined field shall not exceed two (2) percent of the distance from the source to the center of the visually defined field when the surface upon which it appears is perpendicular to the axis of the x-ray beam.
7.11.a.11. Accuracy of kVp. Deviation of actual kVp from the indicated kVp shall not exceed the limits specified by the manufacturer of the x-ray system, or, the actual kVp shall be within ± two (2) kVp of the indicated kVp, whichever limit is more restrictive.
7.11.a.12. Automatic Exposure Control Performance. In addition to Subdivision 7.8.d., mammographic systems in the AEC mode shall be able to maintain constant film density to within an optical density of ± three-tenths (0.3) of the average optical density over the kVp range used clinically, using phantoms of BR-12 or other breast equivalent material thicknesses of two (2) centimeters to six (6) centimeters. If the facility has established a technique chart that utilizes varying technical factors for different breast thicknesses, those adjustments in technique may be used when performing this test.
7.11.a.13. Radiation Output Minimum. At twenty eight (28) kVp, with a focal spot meeting the requirements of Paragraph 7.11.a.5., the mammographic system shall be capable of sustaining a minimum output rate of one hundred thirty (130) C/kg/sec (five hundred [500] mR/sec) for at least three (3) seconds. This output shall be measured at a point four and two-tenths (4.2) centimeters from the surface of the breast support device when the SID is at its maximum and the effect of compression paddle attenuation is included.
7.11.a.14. Screen-film Contact. Cassettes shall not be used for mammography if poor contact of two or more large areas (> one [1] cm in diameter) or a Section longer than one [1] cm and >two (2) mm in width along the chest wall edge can be seen in a forty (40) mesh test.
7.11.a.15. Image quality. The mammographic x-ray imaging system shall be capable of providing an image of a seventy five one-hundredths (0.75) mm fiber, thirty two one-hundredths (0.32) mm speck group, and a seventy five one-hundredths (0.75) mm mass from the conference of Radiation Control Program directors next '92 phantom (or equivalent) on the standard mammographic image receptor system in use at a facility. Mammograms shall not be taken on patients if this minimum is not met. Any fibers, speck groups and masses larger than those specified shall also be imaged.
7.11.a.16. Dose. The mean glandular dose for one craniocaudal view, measured with the phantom referenced in Paragraph 7.11.a.15., based on exposure measured at the breast entrance location, and using dose conversion factors specified by the health care financing administration in their medicare mammography survey protocols, shall not exceed the following values:
7.11.a.16.A. One and five one-hundredths (1.5) mGy (one hundred fifty [150] millirads) for non-grid screen film systems;
7.11.a.16.B. Two and five one-hundredths (2.5) mGy (two hundred fifty [250] millirads) for screen-film systems with grid;
7.11.a.16.C. Four (4) mGy (four hundred [400] millirads) for xerography systems.
7.11.a.17. Technique Settings. The technique settings used for Paragraphs 7.11.a.15. and 16. shall be those used by the facility for its clinical images of a fifty (50) percent adipose, fifty (50) percent glandular, four and two one-hundredths (4.2) cm compressed breast.
7.11.b. Quality Assurance.
7.11.b.1. Quality Assurance Program Required. The registrant shall have a written, on-going equipment quality assurance program specific to mammographic imaging, covering all components of the diagnostic x-ray imaging system, to ensure consistently high-quality images with minimum patient exposure. Responsibilities under this requirement include providing qualified individuals who are to:
7.11.b.1.A. Conduct equipment performance monitoring functions;
7.11.b.1.B. Analyze the monitoring results to determine if there are problems requiring correction;
7.11.b.1.C. Carry out or arrange for the necessary corrective actions when results of quality control tests including those specified in Paragraph 7.11.b.3. indicate the need; and
7.11.b.1.D. Maintain records for a minimum of two years documenting that actions required under Subparagraph 7.11.b.1.A. - C. have been completed.
7.11.b.2. Quality Assurance Program Review. At intervals not to exceed twelve months, the registrant shall:
7.11.b.2.A. Have the annual quality control tests specified in 7.11.b.3. performed by a qualified individual (table 64-23 P) and obtain the results of those tests, incorporating them into the records specified in Subparagraph 7.11.b.1.D.; and
7.11.b.2.B. Conduct a review of the effectiveness of the quality assurance program required in Paragraph 7.11.b.1. and maintain a written report of such review. Records of annual reviews shall be maintained for a minimum of two (2) years and shall be available for agency review.
7.11.b.3. Equipment Quality Control Tests. The registrant shall ensure that the following quality control tests are performed when applicable equipment or components are initially installed, or replaced or serviced (if such servicing affects test results), and performed thereafter at least as often as the frequency specified. If such tests indicate the need for corrective action, based on limits defined here, or in Subdivision 7.11.a., patient mammography may not be performed until correction is accomplished.
7.11.b.3.A. Processor performance by sensitometric - daily, or day of use, prior to the first patient exposure. For any mammography registrant using film processors at multiple locations, such as a mobile service, each processor shall be subject to this requirement. Corrective action shall be taken when:
7.11.b.3.A.1. Deviations of ± fifteen one-hundredths (0.15) or more in optical density from established operating levels occur for readings of mid-density (MD) and density difference (DD) on the sensitometric control charts;
7.11.b.3.A.2. Base plus fog (B+F) exceeds the established operating level by more than three one-hundredths (0.03) in optical density.
7.11.b.3.B. Resolution - upon tube installation or replacement and every twelve (12) months.
7.11.b.3.C. Focal spot size - upon tube installation or tube replacement only.
7.11.b.3.D. Half-value layer - twelve (12) months.
7.11.b.3.E. kVp accuracy and reproducibility - twelve (12) months.
7.11.b.3.F. Output reproducibility, mA linearity, and mR/mAs - twelve (12) months.
7.11.b.3.G. Automatic exposure control reproducibility and performance (response to kVp and phantom thickness variations) - twelve (12) months.
7.11.b.3.H. Screen-film contact and screen artifact detection - six (6) months.
7.11.b.3.I. Compression device performance (releases, level of force, etc) - six (6) months.
7.11.b.3.J. Collimator alignment - twelve (12) months.
7.11.b.3.K. Primary or secondary barrier transmission - upon initial x-ray system installation and significant modification of the system or the facility.
7.11.b.3.L. Image quality (using a test "phantom," which simulates the composition of the breast and includes simulations of breast structures) - monthly for stationary systems, on each day of use for mobile systems, and upon significant service or modification of any mammographic system.
7.11.b.3.M. Densitometer accuracy check - every six (6) months.
7.11.b.3.N. If xeroradiography is used, the quality assurance procedures and frequencies recommended by the manufacturer shall be followed.
7.11.b.4. Additional Quality Control Requirements. The registrant shall perform the following observations and procedures according to the frequency noted and record the results. Corrections of problems noted shall be made and recorded. Records shall be maintained over the most recent two (2) year period.
7.11.b.4.A. Retake Analysis - Three (3) months, or every two hundred fifty (250) patients, whichever comes first.
7.11.b.4.B. Viewbox uniformity - Six (6) months.
7.11.b.4.C. Darkroom integrity (safelight condition, light leaks, etc.) - Six (6) months.
7.11.b.4.D. Screen cleaning - weekly.
7.11.c. Additional Facility Requirements.
7.11.c.1. Masks. Masks shall be provided on the viewboxes to block extraneous light from the viewer's eye when the illuminated surface of the viewbox is larger than the exposed area of the film.
7.11.c.2. Film Processing.
7.11.c.2.A. Film processors utilized for mammography shall be adjusted to and operated at the specifications recommended by the mammographic film manufacturer, or at other settings such that the sensitometric performance is at least equivalent.
7.11.c.2.B. Clinical films and phantom image quality films shall be processed within ten (10) hours of exposure.
7.11.c.3. Instruments and Devices. An image quality phantom, sensitometer, and a calibrated densitometer shall be available to each facility in order to comply with the quality control test frequencies specified in Paragraph 7.11.b.3.
7.11.c.4. Operator Qualifications. The operator of the x-ray machine shall be certified by the american registry of radiologic technologists or an equivalent state licensing body and shall have had specialized training in mammography.
7.11.c.5. Physician Qualifications. The physician interpreting the mammograms shall be certified by the American Board of Radiology, the American Osteopathic Board of Radiology, or board eligible, or equivalent, and shall have had specialized training in mammography and image interpretation.
7.11.c.6. Physicist Qualifications. The person performing evaluation of mammographic system performance in accordance with this rule shall be certified by the American Board of Radiology, the American Board of Medical Physics, or with academic and experience required for board certification, or equivalent, or recognized as competent by an appropriate state agency.
7.11.c.7. Image Retention. Clinical images shall be retained for a minimum of five (5) years.
7.11.c.8. Retake Rate. Corrective action shall be taken if the retake rate exceeds five (5) percent. The retake rate shall be calculated as [repeated + rejected films]/ total number of clinical films.
7.11.c.9. Darkroom Fog. Darkroom fog levels shall not exceed five one-hundredths (0.05) in optical density when sensitized mammographic film of the type used in the facility is exposed to darkroom conditions with safelight on for two (2) minutes. Film shall be sensitized by exposing it to sufficient light from an appropriate intensifying screen or sensitometer so that after processing an optical density of one and two-tenths to one and five-tenths (1.2 - 1.5) is achieved.
7.12. Therapeutic Radiation Machines
7.12.a. Purpose and Scope.
7.12.a.1. This Section establishes requirements, for which the registrant is responsible, for use of therapeutic radiation machines. The provisions of this Section are in addition to, and not in substitution for, other applicable provisions of this rule.
7.12.a.2. The use of therapeutic radiation machines shall be by, or under the supervision of, a licensed practitioner of the healing arts who meets the training and experience criteria established by Subdivision 12.3.c.
7.12.b. Definitions. As used in this Section, the following definitions apply:
7.12.b.1. Absorbed Dose (D) - the mean energy imparted by ionizing radiation to matter. Absorbed dose is determined as the quotient of dE by dM, where dE is the mean energy imparted by ionizing radiation to matter of mass dM.. The SI unit of absorbed dose is joule per kilogram and the special name of the unit of absorbed dose is the Gray (Gy). The previously used special unit of absorbed dose (rad) is being replaced by the gray.
7.12.b.2. Absorbed Dose Rate - absorbed dose per unit time, for machines with timers, or dose monitor unit per unit time for linear accelerators.
7.12.b.3. Accessible Surface - surface of equipment or of an equipment part that can be easily or accidentally touched by persons without the use of a tool.
7.12.b.4. Added Filtration - any filtration which is in addition to the inherent filtration.
7.12.b.5. Air Kerma (K) - the kinetic energy released in air by ionizing radiation. Kerma is determined as the quotient of dE by dM, where dE is the sum of the initial kinetic energies of all the charged ionizing particles liberated by uncharged ionizing particles in air of mass dM.. The SI unit of air kerma is joule per kilogram and the special name for the unit of kerma is the gray (Gy).
7.12.b.6. Barrier - a barrier of radiation absorbing materials used to reduce radiation exposure.
7.12.b.7. Beam Axis - the axis of rotation of the beam limiting device.
7.12.b.8. Beam-limiting Device - a field defining collimator, integral to the therapeutic radiation machine, which provides a means to restrict the dimensions of the useful beam.
7.12.b.9 Beam Monitoring System - a system designed and installed in the radiation head to detect and measure the radiation present in the useful beam.
7.12.b.10. Beam Scattering Foil - a thin piece of material (usually metallic) placed in the beam to scatter a beam of electrons in order to provide a more uniform electron distribution in the useful beam.
7.12.b.11. Bent Beam Linear Accelerator - a linear accelerator geometry in which the accelerated electron beam must change direction by passing through a bending magnet.
7.12.b.12. Changeable Filters - any filter, exclusive of inherent filtration, which can be removed from the useful beam through any electronic, mechanical, or physical process.
7.12.b.13. Contact Therapy System - a therapeutic radiation machine with a short target to skin distance (TSD), usually less than five (5) centimeters.
7.12.b.14. Detector - a device which, in the presence of radiation provides, by either direct or indirect means, a signal or other indication suitable for use in measuring one or more quantities of incident radiation.
7.12.b.15. Dose Monitor Unit (DMU) - a unit response from the beam monitoring system from which the absorbed dose can be calculated.
7.12.b.16. External Beam Radiation Therapy - therapeutic irradiation in which the source of radiation is at a distance from the body.
7.12.b.17. Field-flattening Filter - a filter used to homogenize the absorbed dose rate over the radiation field.
7.12.b.18. Filter - material placed in the useful beam to change beam quality in therapeutic radiation machines subject to Subdivision 7.12.f.
7.12.b.19. Gantry - that part of a radiation therapy system supporting and allowing movements of the radiation head about a center of rotation.
7.12.b.20. Gray (Gy) - the SI unit of absorbed dose, kerma, and specific energy imparted equal to 1 joule per kilogram. The previous unit of absorbed dose (rad) is being replaced by the Gray. (one [1] Gy=one hundred [100] rad).
7.12.b.21. Half-value Layer (HVL) - the thickness of a specified material which attenuates x-radiation or gamma radiation to an extent such that the air kerma rate, exposure rate or absorbed dose rate is reduced to one-half (½) of the value measured without the material at the same point.
7.12.b.22. Interlock - a device preventing the start or continued operation of equipment unless certain predetermined conditions prevail.
7.12.b.23. Interruption of Irradiation - the stopping of irradiation with the possibility of continuing irradiation without resetting of operating conditions at the control panel.
7.12.b.24. Irradiation - the exposure of a living being or matter to ionizing radiation.
7.12.b.25. Isocenter - the center of the sphere through which the useful beam axis passes while the gantry moves through its full range of motions.
7.12.b.26. Kilovolt (kV) [kilo electron volt (keV)] - the energy equal to that acquired by a particle with one electron charge in passing through a potential difference of one thousand volts in a vacuum. [Note: current convention is to use kV for photons and keV for electrons.]
7.12.b.27. Lead Equivalent - the thickness of the material in question affording the same attenuation, under specified conditions, as lead.
7.12.b.28. Leakage Radiation - radiation emanating from the radiation therapy system except for the useful beam.
7.12.b.29. Light Field - the area illuminated by light, simulating the radiation field.
7.12.b.30. mA - milliampere.
7.12.b.31. Megavolt (MV) [mega electron volt (MeV)] - the energy equal to that acquired by a particle with one electron charge in passing through a potential difference of one million volts in a vacuum. [Note: current convention is to use MV for photons and MeV for electrons.]
7.12.b.32. Monitor Unit (MU) -a unit response from the beam monitoring system from which the absorbed dose can be calculated.
7.12.b.31. Moving Beam Radiation Therapy - radiation therapy with any planned displacement of radiation field or patient relative to each other, or with any planned change of absorbed dose distribution. It includes arc, skip, conformal, intensity modulation and rotational therapy.
7.12.b.32. Nominal Treatment Distance:
7.12.b.32.A. For electron irradiation, the distance from the scattering foil, virtual source, or exit window of the electron beam to the entrance surface of the irradiated object along the central axis of the useful beam.
7.12.b.32.B. For x-ray irradiation, the virtual source or target to isocenter distance along the central axis of the useful beam. For non-isocentric equipment, this distance shall be that specified by the manufacturer.
7.12.b.33. Patient - an individual subjected to machine produced external beam radiation for the purposes of medical therapy.
7.12.b.34. Peak Tube Potential - the maximum value of the potential difference across the x-ray tube during an exposure.
7.12.b.35. Periodic Quality Assurance Check - a procedure which is performed to ensure that a previous calibration continues to be valid.
7.12.b.36. Phantom - an object behaving in essentially the same manner as tissue, with respect to absorption or scattering of the ionizing radiation in question.
7.12.b.37. Practical Range of Electrons - corresponds to classical electron range where the only remaining contribution to dose is from Bremsstrahlung X-rays. A further explanation may be found in "Clinical Electron Beam Dosimetry: Report of AAPM Radiation Therapy Committee Task Group 25" [Medical Physics 18(1): 73-109, Jan/Feb. 1991] and ICRU Report 35, "Radiation Dosimetry: Electron Beams with Energies Between 1 and 50 MeV", International Commission on Radiation Units and Measurements, September 15, 1984.
7.12.b.38. Primary Dose Monitoring System - a system which will monitor the useful beam during irradiation and which will terminate irradiation when a pre-selected number of dose monitor units have been delivered.
7.12.b.39. Primary Protective Barrier - the material, excluding filters, placed in the useful beam.
7.12.b.40. Protective Barrier - a barrier of radiation absorbing materials used to reduce radiation exposure.
7.12.b.41. Radiation Detector - a device which, in the presence of radiation provides, by either direct or indirect means, a signal or other indication suitable for use in measuring one or more quantities of incident radiation.
7.12.b.42. Radiation Field - the material which attenuates stray radiation.
7.12.b.43. Radiation Head - the structure from which the useful beam emerges.
7.12.b.44. Radiation Therapy Physicist - an individual qualified in accordance with Paragraph 7.12.c.4.
7.12.b.45. Redundant Beam Monitoring System - a combination of two dose monitoring systems in which each system is designed to terminate irradiation in accordance with a pre-selected number of dose monitor units.
7.12.b.46. Scattered Radiation - ionizing radiation emitted by interaction of ionizing radiation with matter, the interaction being accompanied by a change in direction of the radiation. Scattered primary radiation means that scattered radiation which has been deviated in direction only by materials irradiated by the useful beam.
7.12.b.47. Secondary Dose Monitoring System - a system which will terminate irradiation in the event of failure of the primary dose monitoring system.
7.12.b.48. Secondary Protective Barrier - the material which attenuates stray radiation.
7.12.b.49. Shadow Tray - a device attached to the radiation head to support auxiliary beam blocking material.
7.12.b.50. Shutter - a device attached to the tube housing assembly which can totally intercept the useful beam and which has a lead equivalency not less than that of the tube housing assembly.
7.12.b.51. Sievert (Sv) - the SI unit of dose equivalent. The unit of dose equivalent is the joule per kilogram. The previous unit of dose equivalent (Rem) is being replaced by the Sievert. (One [1] Sv=one hundred [100] Rem).
7.12.b.52. Simulator (Radiation Therapy Simulation System) - any x-ray system intended for localizing the volume to be exposed during radiation therapy and reproducing the position and size of the therapeutic irradiation field.
7.12.b.53. Source - the region or material from which the radiation emanates.
7.12.b.54. Source-skin Distance (SSD) - the distance measured along the beam axis from the center of the front surface of the x-ray target or electron virtual source to the surface of the irradiated object or patient.
7.12.b.55. Stationary beam radiation therapy - radiation therapy without displacement of one or more mechanical axes relative to the patient during irradiation.
7.12.b.56. Stray Radiation - the sum of leakage and scattered radiation.
7.12.b.57. Target - that part of an x-ray tube or accelerator onto which a beam of accelerated particles is directed to produce ionizing radiation or other particles.
7.12.b.58. Target-skin Distance (TSD) - the distance measured along the beam axis from the center of the front surface of the x-ray target or electron virtual source to the surface of the irradiated object or patient.
7.12.b.59. Tenth-value Layer (TVL) - s the thickness of a specified material which attenuates x-radiation or gamma radiation to an extent such that the air kerma rate, exposure rate, or absorbed dose rate is reduced to one-tenth (0.1) of the value measured without the material at the same point.
7.12.b.60. Termination of Irradiation - the stopping of irradiation in a fashion which will not permit continuance of irradiation without the resetting of operating conditions at the control panel.
7.12.b.61. Therapeutic Radiation Machine - x-ray or electron-producing equipment designed and used for external beam radiation therapy.
7.12.b.62. Tube - an x-ray tube, unless otherwise specified.
7.12.b.63. Tube Housing Assembly - the tube housing with tube installed. It includes high-voltage or filament transformers and other appropriate elements when such are contained within the tube housing.
7.12.b.64. Useful Beam - the radiation emanating from the tube housing port or the radiation head and passing through the aperture of the beam limiting device when the exposure controls are in a mode to cause the therapeutic radiation machine to produce radiation.
7.12.b.65. Virtual Source - a point from which radiation appears to originate.
7.12.b.66. Wedge Filter - a filter which effects continuous change in transmission over all or a part of the useful beam.
7.12.b.67. X-ray Tube - any electron tube which is designed to be used primarily for the production of x-rays.
7.12.c. General Administrative Requirements for Facilities Using Therapeutic Radiation Machines.
7.12.c.1. The registrant shall be responsible for directing the operation of the therapeutic radiation machines that have been registered with the agency. The registrant or the registrant's agent shall ensure that the requirements of Subsection 7.12. are met in the operation of the therapeutic radiation machines.
7.12.c.2. A therapeutic radiation machine that does not meet the provisions of this rule shall not be used for irradiation of patients.
7.12.c.3. The registrant for any therapeutic radiation machine subject to Subdivisions 7.12.f. or 7.12.g. shall require the radiation therapy physicist to:
7.12.c.3.A. Be registered with the agency, under the provisions of Section 2. of this rule, as a provider of radiation services in the area of calibration and compliance surveys of external beam radiation therapy units; and
7.12.c.3.B. Be certified by the American Board of Radiology in:
7.12.c.3.B.1. Therapeutic Radiological Physics; or
7.12.c.3.B.2. Roentgen-ray and Gamma-ray Physics; or
7.12.c.3.B.3. X-ray and Radium Physics; or
7.12.c.3.B.4. Radiological Physics; or
7.12.c.3.C. Be certified by the American Board of Medical Physics in Radiation Oncology Physics; or
7.12.c.3.D. Hold a master's or doctor's degree in physics, biophysics, radiological physics, or health physics, and have completed 1 year of full time training in therapeutic radiological physics and also 1 year of full time work experience under the supervision of a radiation therapy physicist at a medical institution. To meet this requirement, the individual shall have performed the tasks listed in 7.12.d.1., 7.12.f.16. or 7.12.g.20., and 7.12.f.17.or 7.12.g.21. under the supervision of a radiation therapy physicist during the year of work experience.
7.12.c.3.E. Notwithstanding the provisions of 7.12.c.3.C., certification pursuant 7.12.c.3.B. and 7.12.c.3.C. shall be required on or before December 31, 1999, for all persons currently qualifying as a radiation therapy physicist pursuant to 7.12.c.3.D.
7.12.c.4. Written safety procedures and rules shall be developed by a radiation therapy physicist and shall be available in the control area of a therapeutic radiation machine, including any restrictions required for the safe operation of the particular therapeutic radiation machine. The operator shall be able to demonstrate familiarity with this rule.
7.12.c.5. Individuals shall not be exposed to the useful beam except for medical therapy purposes and unless such exposure has been ordered in writing by a licensed practitioner of the healing arts who is specifically identified on the registration. This provision specifically prohibits deliberate exposure of an individual for training, demonstration or other non-healing-arts purposes.
7.12.c.6. Visiting Authorized User.
7.12.c.6.A. Notwithstanding the provisions of 7.12.c.5., a registrant may permit any physician to act as a visiting authorized user under the term of the registrant's registration for up to sixty (60) days per calendar year under the following conditions:
7.12.c.6.A.1. The visiting authorized user has the prior written permission of the registrant's management and, if the use occurs on behalf of an institution, the institution's radiation safety committee; and
7.12.c.6.A.2. The visiting authorized user meets the requirements established for authorized users in 7.12.c.3.B.; and
7.12.c.6.a.3. The registrant maintains copies of all records specified by 7.12.c.6. for five (5) years from the date of the last visit.
7.12.c.6.B. All individuals associated with the operation of a therapeutic radiation machine shall be instructed in and shall comply with the provisions of the registrant's quality management program. In addition to the requirements of Subsection 7.12, these individuals are also subject to the requirements of Subsection 6.5., Subsection 6.9. and Subsection 6.17. of this rule.
7.12.c.7. Information and Maintenance Record and Associated Information. The registrant shall maintain the following information in a separate file or package for each therapeutic radiation machine, for inspection by the agency:
7.12.c.7.A. Report of acceptance testing;
7.12.c.7.B. Records of all surveys, calibrations, and periodic quality assurance checks of the therapeutic radiation machine required by Subsection 7.12., as well as the names of persons who performed such activities;
7.12.c.7.C. Records of maintenance and modifications performed on the therapeutic radiation machine after July 1, 2001, as well as the names of persons who performed such services;
7.12.c.7.D. Signature of person authorizing the return of therapeutic radiation machine to clinical use after service, repair, or upgrade.
7.12.c.8. Records Retention. All records required by Subsection 7.12. shall be retained until disposal is authorized by the agency unless another retention period is specifically authorized in Subsection 7.12. All required records shall be retained in an active file from at least the time of generation until the next Agency inspection. Any required record generated prior to the last agency inspection may be microfilmed or otherwise archived as long as a complete copy of said record can be retrieved until such time as the agency authorizes final disposal.
7.12.d. General Technical Requirements for Facilities Using Therapeutic Radiation Machines.
7.12.d.1. Protection Surveys.
7.12.d.1.A. The registrant shall ensure that radiation protection surveys of all new facilities, and existing facilities not previously surveyed are performed with an operable radiation measurement survey instrument calibrated in accordance with 7.12.h. The radiation protection survey shall be performed by, or under the direction of, a radiation therapy physicist or a qualified expert and shall verify that, with the therapeutic radiation machine in a "BEAM-ON" condition, with the largest clinically available treatment field and with a scattering phantom in the useful beam of radiation:
7.12.d.1.A.1. Radiation levels in restricted areas are not likely to cause personnel exposures in excess of the limits specified in Subdivision 6.5.a. of this rule.; and
7.12.d.1.A.2. Radiation levels in unrestricted areas do not exceed the limits specified in Subdivisions 6.13.a. and 6.13.b. of this rule.
7.12.d.1.B. In addition to the requirements of Subparagraph 7.12.d.1.A., a radiation protection survey shall also be performed prior to any subsequent medical use and:
7.12.d.1.B.1. After making any change in the treatment room shielding;
7.12.d.1.B.2. After making any change in the location of the therapeutic radiation machine within the treatment room;
7.12.d.1.B.3. After relocating the therapeutic radiation machine; or
7.12.d.1.B.4. Before using the therapeutic radiation machine in a manner that could result in increased radiation levels in areas outside the external beam radiation therapy treatment room.
7.12.d.1.C. The survey record shall indicate all instances where the facility, in the opinion of the radiation therapy physicist or a qualified expert, is in violation of applicable rules. The survey record shall also include: the date of the measurements; the reason the survey is required; the manufacturer's name; model number and serial number of the therapeutic radiation machine; the instruments used to measure radiation levels; a plan of the areas surrounding the treatment room that were surveyed; the measured dose rate at several points in each area expressed in microsieverts or millirems per hour; the calculated maximum level of radiation over a period of one (1) week for each restricted and unrestricted area; and the signature of the individual responsible for conducting the survey;
7.12.d.1.D. If the results of the surveys required by 7.12.d.1.A. or 7.12.d.1.B. indicate any radiation levels in excess of the respective limit specified in Subparagraph 7.12.d.1.A., the registrant shall lock the control in the "OFF" position and not use the unit:
7.12.d.1.D.1. Except as may be necessary to repair, replace, or test the therapeutic radiation machine, the therapeutic radiation machine shielding, or the treatment room shielding; or
7.12.d.1.D.2. Until the registrant has received a specific exemption from the agency.
7.12.d.2. Modification of radiation therapy unit or room before beginning a treatment program. If the survey required by Paragraph 7.12.d.1. indicates that an individual in an unrestricted area may be exposed to levels of radiation greater than those permitted by Subdivisions 6.13.a. and 6.13.b. of this rule, before beginning the treatment program the registrant shall:
7.12.d.2.A. Either equip the unit with beam direction interlocks or add additional radiation shielding to ensure compliance with Subdivisions 6.13.a. and 6.13.b. of this rule;
7.12.d.2.B. Perform the survey required by Paragraph 7.12.d.1. again; and
7.12.d.2.C. Include in the report required by Paragraph 7.12.d.4. the results of the initial survey, a description of the modification made to comply with Subparagraph 7.12.d.2.A., and the results of the second survey; or
7.12.d.2.D. Request and receive a registration amendment under Subdivision 6.13.c. of this rule that authorizes radiation levels in unrestricted areas greater than those permitted by Subdivision 6.13.a and 6.13.b. of this rule.
7.12.d.3. Dosimetry Equipment.
7.12.d.3.A. The registrant shall have a calibrated dosimetry system available for use. The system shall have been calibrated by the National Institute for Standards and Technology (NIST) or by an American Association of Physicists in Medicine (AAPM) accredited dosimetry calibration laboratory (ADCL). The calibration shall have been performed within the previous twenty four (24) months and after any servicing that may have affected system calibration. An independent survey shall be conducted by a qualified expert or radiation therapy physicist other that the person performing the original survey prior to the equipment being used except as described in Subparagraph 7.12.d.1.D.
7.12.d.3.A.1. For beams with energies greater than one (1) MV (one [1] MeV), the dosimetry system shall have been calibrated for Cobalt-60;
7.12.d.3.A.2. For beams with energies equal to or less than one (1) MV (one [1] MeV), the dosimetry system shall have been calibrated at an energy (energy range) appropriate for the radiation being measured;
7.12.d.3.B. The registrant shall have available for use a dosimetry system for quality assurance check measurements. To meet this requirement, the system may be compared with a system that has been calibrated in accordance with Subparagraph 7.12.d.3.A. This comparison shall have been performed within the previous twelve (12) months and after each servicing that may have affected system calibration. The quality assurance check system may be the same system used to meet the requirement in 7.12.d.3.1.;
7.12.d.3.C. The registrant shall maintain a record of each dosimetry system calibration, intercomparison, and comparison for the duration of the registration. For each calibration, intercomparison, or comparison, the record shall include: the date; the model numbers and serial numbers of the instruments that were calibrated, inter-compared, or compared as required by 7.12.d.3.A. and 7.12.d.3.B.; the correction factors that were determined; the names of the individuals who performed the calibration, intercomparison, or comparison; and evidence that the intercomparison was performed by, or under the direct supervision and in the physical presence of, a radiation therapy physicist.
7.12.d.4. Reports of external beam radiation therapy surveys and measurements. The registrant for any therapeutic radiation machine subject to Subdivisions 7.12.f. or 7.12.g. shall furnish a copy of the records required in Paragraphs 7.12.d.1. and 7.12.d.2. to the agency within thirty (30) days following completion of the action that initiated the record requirement.
7.12.e. Quality Management Program. The facility shall implement a quality management program. The facility may use the quality management programs found in either Table 64-23 V or Table 64-23 W.
7.12.f. Therapeutic Radiation Machines of Less Than Five Hundred (500) kV.
7.12.f.1. Leakage Radiation. When the x-ray tube is operated at its maximum rated tube current for the maximum kV, the leakage air kerma rate shall not exceed the value specified at the distance specified for that classification of therapeutic radiation machine:
7.12.f.1.A. Five to Fifty (5 to 50) kV Systems. The leakage air kerma rate measured at any position 5 centimeters from the tube housing assembly shall not exceed one (1) mGy (one hundred [100] mRad) in any one hour.
7.12.f.1.B. Greater than fifty (>50) and less than five hundred (<500) kV Systems. The leakage air kerma rate measured at a distance of one (1) meter from the target in any direction shall not exceed one (1) cGy (one [1] Rad) in any one (1) hour. This air kerma rate measurement may be averaged over areas no larger than one hundred (100) square centimeters. In addition, the air kerma rate at a distance of five (5) centimeters from the surface of the tube housing assembly shall not exceed thirty (30) cGy (thirty [30] rad) per hour.
7.12.f.1.C. For each therapeutic radiation machine, the registrant shall determine, or obtain from the manufacturer, the leakage radiation existing at the positions specified in Subparagraph 7.12.f.1.A. and 7.12.f.1.B. for the specified operating conditions. Records on leakage radiation measurements shall be maintained at the installation for inspection by the agency.
7.12.f.2. Permanent beam limiting devices. Permanent diaphragms or cones used for limiting the useful beam shall provide at least the same degree of attenuation as required for the tube housing assembly.
7.12.f.3. Adjustable or Removable Beam Limiting Devices.
7.12.f.3.A. All adjustable or removable beam limiting devices, diaphragms, cones or blocks shall not transmit more than five (5) percent of the useful beam for the most penetrating beam used;
7.12.f.3.B. When adjustable beam limiting devices are used, the position and shape of the radiation field shall be indicated by a light beam.
7.12.f.4. Filter System. The filter system shall be so designed that:
7.12.f.4.A. Filters can not be accidentally displaced at any possible tube orientation;
7.12.f.4.B. For equipment installed after July 1, 2001, an interlock system prevents irradiation if the proper filter is not in place;
7.12.f.4.C. The air kerma rate escaping from the filter slot shall not exceed one (1) cGy (1 Rad) per hour at 1 meter under any operating conditions; and
7.12.f.4.D. Each filter shall be marked as to its material of construction and its thickness.
7.12.f.5. Tube Immobilization.
7.12.f.5.A. The x-ray tube shall be so mounted that it can not accidentally turn or slide with respect to the housing aperture; and
7.12.f.5.B. The tube housing assembly shall be capable of being immobilized for stationary portal treatments.
7.12.f.6. Source Marking. The tube housing assembly shall be so marked that it is possible to determine the location of the source to within five (5) millimeters, and such marking shall be readily accessible for use during calibration procedures.
7.12.f.7. Beam Block. Contact therapy tube housing assemblies shall have a removable shield of material, equivalent in attenuation to five-tenths (0.5) millimeters of lead at one hundred (100) kV, which can be positioned over the entire useful beam exit port during periods when the beam is not in use.
7.12.f.8. Timer. A suitable irradiation control device shall be provided to terminate the irradiation after a pre-set time interval.
7.12.f.8.A. A timer with a display shall be provided at the treatment control panel. The timer shall have a pre-set time selector and an elapsed time or time remaining indicator;
7.12.f.8.B. The timer shall be a cumulative timer that activates with an indication of "BEAM-ON" and retains its reading after irradiation is interrupted or terminated. After irradiation is terminated and before irradiation can be reinitiated, it shall be necessary to reset the elapsed time indicator;
7.12.f.8.C. The timer shall terminate irradiation when a pre-selected time has elapsed, if any dose monitoring system present has not previously terminated irradiation;
7.12.f.8.D. The timer shall permit accurate pre-setting and determination of exposure times as short as one (1) second;
7.12.f.8.E. The timer shall not permit an exposure if set at zero;
7.12.f.8.F. The timer shall not activate until the shutter is opened when irradiation is controlled by a shutter mechanism unless calibration includes a timer error correction to compensate for mechanical lag; and
7.12.f.8.G. Timer shall be accurate to within one (1) percent of the selected value or one (1) second, whichever is greater.
7.12.f.9. Control Panel Functions. The control panel, in addition to the displays required by other provisions in Subdivision 7.12.f., shall have:
7.12.f.9.A. An indication of whether electrical power is available at the control panel and if activation of the x-ray tube is possible;
7.12.f.9.B. An indication of whether x-rays are being produced;
7.12.f.9.C. A means for indicating x-ray tube potential and current;
7.12.f.9.D. The means for terminating an exposure at any time;
7.12.f.9.E. A locking device which will prevent unauthorized use of the therapeutic radiation machine; and
7.12.f.9.F. For therapeutic radiation machines manufactured after July 1, 2001, a positive display of specific filter or filters in the beam.
7.12.f.10. Multiple Tubes. When a control panel may energize more than one (1) x-ray tube:
7.12.f.10.A. It shall be possible to activate only one x-ray tube at any time;
7.12.f.10.B. There shall be an indication at the control panel identifying which x-ray tube is activated; and
7.12.f.10.C. There shall be an indication at the tube housing assembly when that tube is energized.
7.12.f.11. Target-to-Skin Distance (TSD). There shall be a means of determining the central axis TSD to within one (1) centimeter and of reproducing this measurement to within two (2) millimeters thereafter.
7.12.f.12. Shutters. Unless it is possible to bring the x-ray output to the prescribed exposure parameters within five (5) seconds after the x-ray "ON" switch is energized, the beam shall be attenuated by a shutter having a lead equivalency not less than that of the tube housing assembly. In addition, after the unit is at operating parameters, the shutter shall be controlled by the operator from the control panel. An indication of shutter position shall appear at the control panel.
7.12.f.13. Low Filtration X-ray Tubes. Each therapeutic radiation machine equipped with a beryllium or other low-filtration window shall be clearly labeled as such upon the tube housing assembly and shall be provided with a permanent warning device on the control panel that is activated when no additional filtration is present, to indicate that the dose rate is very high.
7.12.f.14. Facility design requirements for therapeutic radiation machines capable of operating in the range fifty (50) kV to five hundred (500) kV. In addition to shielding adequate to meet requirements of Subdivision 7.12.i., the treatment room shall meet the following design requirements:
7.12.f.14.A. Aural Communication. Provision shall be made for continuous two-way aural communication between the patient and the operator at the control panel;
7.12.f.14.B. Viewing Systems. Provision shall be made to permit continuous observation of the patient during irradiation and the viewing system shall be so located that the operator can observe the patient from the control panel. The therapeutic radiation machine shall not be used for patient irradiation unless at least one viewing system is operational.
7.12.f.15. Additional Requirements. Treatment rooms that contain a therapeutic radiation machine capable of operating above one hundred fifty (150) kV shall meet the following additional requirements:
7.12.f.15.A. All protective barriers shall be fixed except for entrance doors or beam interceptors;
7.12.f.15.B. The control panel shall be located outside the treatment room or in a totally enclosed booth, which has a ceiling, inside the room;
7.12.f.15.C. Interlocks shall be provided such that all entrance doors, including doors to any interior booths, shall be closed before treatment can be initiated or continued. If the radiation beam is interrupted by any door opening, it shall not be possible to restore the machine to operation without closing the door and reinitiating irradiation by manual action at the control panel; and
7.12.f.15.D. When any door referred to in Subparagraph 7.12.f.15.C. is opened while the x-ray tube is activated, the air kerma rate at a distance of one (1) meter from the source shall be reduced to less than one (1) mGy (one hundred [100] mRad) per hour.
7.12.f.16. Full Calibration Measurements.
7.12.f.16.A. Full calibration of a therapeutic radiation machine subject to Subdivision 7.12.f. shall be performed by, or under the direct supervision of, a radiation therapy physicist:
7.12.f.16.A.1. Before the first medical use following installation or reinstallation of the therapeutic radiation machine;
7.12.f.16.A.2. At intervals not exceeding one (1) year; and
7.12.f.16.A.3. Before medical use under the following conditions: 7.12.f.16.A.3.(a). When- ever quality assurance check measurements indicate that the radiation output differs by more than five (5) percent from the value obtained at the last full calibration and the difference cannot be reconciled; and 7.12.f.16.A.3.(b). Follow- ing any component replacement, major repair, or modification of components that could significantly affect the characteristics of the radiation beam.
7.12.f.16.A.4. Notwithstand- ing the requirements of Part 7.12.f.16.A.3.: 7.12.f.16.A.4.(a). Full calibration of therapeutic radiation machines with multi-energy capabilities is required only for those modes or energies that are not within their acceptable range; and 7.12.f.16.A.4.(b). If the repair, replacement or modification does not affect all energies, full calibration shall be performed on the affected energy that is in most frequent clinical use at the facility. The remaining energies may be validated with quality assurance check procedures against the criteria in subpart 7.12.f.16.A.3.(a).
7.12.f.16.B. To satisfy the requirement of Subparagraph 7.12.f.16.A., full calibration shall include all measurements recommended for annual calibration by NCRP Report 69, "Dosimetry of X-ray and Gamma Ray Beams for Radiation Therapy in the Energy Range 10 keV to 50 MeV" (1981).
7.12.f.16.C. The registrant shall maintain a record of each calibration for the duration of the registration. The record shall include: the date of the calibration; the manufacturer's name, model number, and serial number for both the therapeutic radiation machine and the x-ray tube; the model numbers and serial numbers of the instruments used to calibrate the therapeutic radiation machine; and the signature of the radiation therapy physicist responsible for performing the calibration.
7.12.f.17. Periodic Quality Assurance Checks.
7.12.f.17.A. Periodic quality assurance checks shall be performed on therapeutic radiation machines subject to Subdivision 7.12.f., which are capable of operation at greater than or equal to fifty (50) kV.
7.12.f.17.B. To satisfy the requirement of Subparagraph 7.12.f.17.A., quality assurance checks shall meet the following requirements:
7.12.f.17.B.1. The registrant shall perform quality assurance checks in accordance with written procedures established by the radiation therapy physicist.; and
7.12.f.17.B.2. The quality assurance check procedures shall specify the frequency at which tests or measurements are to be performed. The quality assurance check procedures shall specify that the quality assurance check shall be performed during the calibration specified in Subparagraph 7.12.f.16.A. The acceptable tolerance for each parameter measured in the quality assurance check, when compared to the value for that parameter determined in the calibration specified in Subparagraph 7.12.f.16.A., shall be stated.
7.12.f.17.C. The cause for a parameter exceeding a tolerance set by the radiation therapy physicist shall be investigated and corrected before the system is used for patient irradiation;
7.12.f.17.D. Whenever a quality assurance check indicates a significant change in the operating characteristics of a system, as specified in the radiation therapy physicist's quality assurance check procedures, the system shall be recalibrated as required in Subparagraph 7.12.f.16.A.;
7.12.f.17.E. The registrant shall use the dosimetry system described in Subparagraph 7.12.d.3.B. to make the quality assurance check required in Subparagraph 7.12.f.17.A.;
7.12.f.17.F. The registrant shall have the radiation therapy physicist review and sign the results of each radiation output quality assurance check within one (1) month of the date that the check was performed;
7.12.f.17.G. The registrant shall ensure that safety quality assurance checks of therapeutic radiation machines subject to Subdivision 7.12.f. are performed at intervals not to exceed one (1) month;
7.12.f.17.H. Notwithstanding the requirements of Subparagraphs 7.12.f.17.F. and Subparagraph 7.12.f.17.G., the registrant shall ensure that no therapeutic radiation machine is used to administer radiation to humans unless the quality assurance checks required by Subparagraphs 7.12.f.17.F. and Subparagraph 7.12.f.17.G. have been performed within the thirty (30) day period immediately prior to said administration;
7.12.f.17.I. To satisfy the requirement of Subparagraph 7.12.f.17.G., safety quality assurance checks shall ensure proper operation of:
7.12.f.17.I.1. Electrical interlocks at each external beam radiation therapy room entrance;
7.12.f.17.I.2. The "BEAM-ON" and termination switches;
7.12.f.17.I.3. Beam condition indicator lights on the access doors, control console, and in the radiation therapy room;
7.12.f.17.I.4. Viewing systems;
7.12.f.17.I.5. If applicable, electrically operated treatment room doors from inside and outside the treatment room.
7.12.f.17.J. The registrant shall maintain a record of each quality assurance check required by Subparagraph 7.12.f.17.A. and Subparagraph 7.12.f.17.g. for three (3) years. The record shall include: the date of the quality assurance check; the manufacturer's name, model number, and serial number of the therapeutic radiation machine; the manufacturer's name; model number and serial number for the instruments used to measure the radiation output of the therapeutic radiation machine; and the signature of the individual who performed the periodic quality assurance check.
7.12.f.18. Operating Procedures.
7.12.f.18.A. The therapeutic radiation machine shall not be used for irradiation of patients unless the requirements of Subparagraph 7.12.f.16. And Subparagraph 7.12.f.17. have been met;
7.12.f.18.B. Therapeutic radiation machines shall not be left unattended unless secured pursuant to Subparagraph 7.12.f.1.E.;
7.12.f.18.C. When a patient must be held in position for radiation therapy, mechanical supporting or restraining devices shall be used;
7.12.f.18.D. The tube housing assembly shall not be held by an individual during operation unless the assembly is designed to require such holding and the peak tube potential of the system does not exceed fifty (50) kV. In such cases, the holder shall wear protective gloves and apron of not less than five-tenths (0.5) millimeters lead equivalency at one hundred (100) kV;
7.12.f.18.E. A copy of the current operating and emergency procedures shall be maintained at the therapeutic radiation machine control console; and
7.12.f.18.F. No individual other than the patient shall be in the treatment room during exposures from therapeutic radiation machines operating above one hundred fifty (150) kV. At energies less than or equal to one hundred fifty (150) kV, any individual, other than the patient, in the treatment room shall be protected by a barrier sufficient to meet the requirements of Subsection 6.5 of this rule.
7.12.f.19. Possession of Survey Instruments. Each facility location authorized to use a therapeutic radiation machine in accordance with Subdivision 7.12.f. shall possess appropriately calibrated portable monitoring equipment. As a minimum, such equipment shall include a portable radiation measurement survey instrument capable of measuring dose rates over the range ten (10) Sv (one [1] mRem) per hour to ten (10) mSv (one thousand [1000] mRem) per hour. The survey instruments shall be operable and calibrated in accordance with Subdivision 7.12.h.
7.12.g. Therapeutic Radiation Machines - photon therapy systems (five hundred [500] kV and above) and electron therapy systems (five hundred [500] keV and above).
7.12.g.1. Possession of Survey Instruments. Each facility location authorized to use a therapeutic radiation machine in accordance with Subdivision 7.12.g. shall possess appropriately calibrated portable monitoring equipment. As a minimum, such equipment shall include a portable radiation measurement survey instrument capable of measuring dose rates over the range ten (10) Sv (one [1] mRem) per hour to ten (10) mSv (one thousand [1000] mRem) per hour. The survey instruments shall be operable and calibrated in accordance with Subsection 7.12.h.
7.12.g.2. Leakage Radiation Outside the Maximum Useful Beam in Photon and Electron Modes.
7.12.g.2.A. The absorbed dose due to leakage radiation (excluding neutrons) at any point outside the maximum sized useful beam, but within a circular plane of radius 2 meters which is perpendicular to and centered on the central axis of the useful beam at the nominal treatment distance (i.e. patient plane), shall not exceed a maximum of two-tenths (0.2) percent and an average of one-tenth (0.1) percent of the absorbed dose on the central axis of the beam at the nominal treatment distance. Measurements shall be averaged over an area not exceeding one hundred (100) square centimeters at a minimum of sixteen (16) points uniformly distributed in the plane;
7.12.g.2.B. Except for the area defined in Subparagraph 7.12.g.2.A., the absorbed dose due to leakage radiation (excluding neutrons) at one (1) meter from the electron path between the electron source and the target or electron window shall not exceed five-tenths (0.5) percent of the absorbed dose on the central axis of the beam at the nominal treatment distance. Measurements shall be averaged over an area not exceeding one hundred (100) square centimeters;
7.12.g.2.C. For equipment manufactured after July 1, 2001, the neutron absorbed dose outside the useful beam shall be in compliance with International Electrotechnical Commission (IEC) Document 601-2-1; and
7.12.g.2.D. For each therapeutic radiation machine, the registrant shall determine, or obtain from the manufacturer, the leakage radiation existing at the positions specified in Subparagraphs 7.12.g.2.A. through 7.12.g.2.C. for the specified operating conditions. Records on leakage radiation measurements shall be maintained at the installation for inspection by the agency.
7.12.g.3. Leakage Radiation Through Beam Limiting Devices.
7.12.g.3.A. Photon Radiation. All adjustable or interchangeable beam limiting devices shall attenuate the useful beam such that at the nominal treatment distance, the maximum absorbed dose anywhere in the area shielded by the beam limiting devices shall not exceed two (2) percent of the maximum absorbed dose on the central axis of the useful beam measured in a ten (10) centimeter by ten (10) centimeter radiation field;
7.12.g.3.B. Electron Radiation. All adjustable or interchangeable electron applicators shall attenuate the radiation, including but not limited to photon radiation generated by electrons incident on the beam limiting device and electron applicator and other parts of the radiation head, such that the absorbed dose in a plane perpendicular to the central axis of the useful beam at the nominal treatment distance shall not exceed:
7.12.g.3.B.1. A maximum of two (2) percent and average of five-tenths (0.5) percent of the absorbed dose on the central axis of the useful beam at the nominal treatment distance. This limit shall apply beyond a line seven (7) centimeters outside the periphery of the useful beam; and
7.12.g.3.B.2. A maximum of ten (10) percent of the absorbed dose on the central axis of the useful beam at the nominal treatment distance. This limit shall apply beyond a line two (2) centimeters outside the periphery of the useful beam..
7.12.g.3.C. Measurement of Leakage Radiation.
7.12.g.3.C.1. Photon Radiation. Measurements of leakage radiation through the beam limiting devices shall be made with the beam limiting devices closed and any residual aperture blocked by at least two (2) tenth value layers of suitable absorbing material. In the case of overlapping beam limiting devices, the leakage radiation through each set shall be measured independently at the depth of maximum dose. Measurements shall be made using a radiation detector of area not exceeding ten (10) square centimeters;
7.12.g.3.C.2. Electron Radiation. Measurements of leakage radiation through the electron applicators shall be made with the electron beam directed into the air and using a radiation detector of area up to but not exceeding one (1) square centimeter suitably protected against radiation which has been scattered from material beyond the radiation detector. Measurements shall be made using one (1) centimeter of water equivalent build up material.
7.12.g.4. Filters or Wedges.
7.12.g.4.A. Each wedge filter that is removable from the system shall be clearly marked with an identification number. For removable wedge filters, the nominal wedge angle shall appear on the wedge or wedge tray (if permanently mounted to the tray). If the wedge or wedge tray is significantly damaged, the wedge transmission factor shall be redetermined;
7.12.g.4.B. If the absorbed dose rate information required by Paragraph 7.12.g.1. relates exclusively to operation with a field flattening filter or beam scattering foil in place, such foil or filter shall be removable only by the use of tools;
7.12.g.4.C. For equipment manufactured after July 1, 2001 which utilizes wedge filters, interchangeable field flattening filters, or interchangeable beam scattering foils:
7.12.g.4.C.1. Irradiation shall not be possible until a selection of a filter or a positive selection to use "no filter" has been made at the treatment control panel, either manually or automatically;
7.12.g.4.C.2. An interlock system shall be provided to prevent irradiation if the filter selected is not in the correct position;
7.12.g.4.C.3. A display shall be provided at the treatment control panel showing the wedge filters, interchangeable field flattening filters, or interchangeable beam scattering foils in use; and
7.12.g.4.C.4. An interlock shall be provided to prevent irradiation if any filter or beam scattering foil selection operation carried out in the treatment room does not agree with the filter or beam scattering foil selection operation carried out at the treatment control panel.
7.12.g.5. Stray radiation in the useful beam. For equipment manufactured after July 1, 2001, the registrant shall determine during acceptance testing, or obtain from the manufacturer, data sufficient to ensure that x-ray stray radiation in the useful electron beam, absorbed dose at the surface during x-ray irradiation and stray neutron radiation in the useful x-ray beam are in compliance with International Electrotechnical Commission (IEC) Document 601-2-1 (most current revision).
7.12.g.6. Beam Monitors. All therapeutic radiation machines subject to Subdivision 7.12.g. shall be provided with redundant beam monitoring systems. The sensors for these systems shall be fixed in the useful beam during treatment to indicate the dose monitor unit rate.
7.12.g.6.A. Equipment manufactured after July 1, 2001 shall be provided with at least 2 independently powered integrating dose meters. Alternatively, common elements may be used if the production of radiation is terminated upon failure of any common element.
7.12.g.6.B. Equipment manufactured on or before July 1, 2001 shall be provided with at least one (1) radiation detector. This detector shall be incorporated into a useful beam monitoring system;
7.12.g.6.C. The detector and the system into which that detector is incorporated shall meet the following requirements:
7.12.g.6.C.1. Each detector shall be removable only with tools and, if movable, shall be interlocked to prevent incorrect positioning;
7.12.g.6.C.2. Each detector shall form part of a beam monitoring system from whose readings in dose monitor units the absorbed dose at a reference point can be calculated;
7.12.g.6.C.3. Each beam monitoring system shall be capable of independently monitoring, interrupting, and terminating irradiation; and
7.12.g.6.C.4. For equipment manufactured after July 1, 2001, the design of the beam monitoring systems shall ensure that the: 7.12.g.6.C.4.(a). Mal- functioning of one system shall not affect the correct functioning of the other systems; and 7.12.g.6.C.4.(b). Failure of either system shall terminate irradiation or prevent the initiation of radiation.
7.12.g.6.C.5. Each beam monitoring system shall have a legible display at the treatment control panel. For equipment manufactured after July 1, 2001, each display shall: 7.12.g.6.C.5.(a). Main- tain a reading until intentionally reset; 7.12.g.6.C.5.(b). Have only one scale and no electrical or mechanical scale multiplying factors; 7.12.g.6.C.5.(c). Utilize a design such that increasing dose is displayed by increasing numbers; and 7.12.g.6.C.5.(d). In the event of power failure, the beam monitoring information required in Part 7.12.g.5.E.3. displayed at the control panel at the time of failure shall be retrievable in at least one system for a twenty (20) minute period of time.
7.12.g.7. Beam Symmetry.
7.12.g.7.A. Bent-beam linear accelerators subject to 7.12.g. shall be provided with auxiliary devices to monitor beam symmetry;
7.12.g.7.B. The devices referenced in Subparagraph 7.12.g.7.A. shall be able to detect field asymmetry greater than ten (10) percent; and
7.12.g.7.C. The devices referenced in Subparagraph 7.12.g.7.A. shall be configured to terminate irradiation if the specifications in Subparagraph 7.12.g.7.B. can not be maintained.
7.12.g.8. Selection and Display of Dose Monitor Units.
7.12.g.8.A. Irradiation shall not be possible until a new selection of a number of dose monitor units has been made at the treatment control panel;
7.12.g.8.B. The pre-selected number of dose monitor units shall be displayed at the treatment control panel until reset manually for the next irradiation;
7.12.g.8.C. After termination of irradiation, it shall be necessary to reset the dosimeter display before subsequent treatment can be initiated; and
7.12.g.8.D. For equipment manufactured after July 1, 2001, after termination of irradiation, it shall be necessary for the operator to reset the pre-selected dose monitor units before irradiation can be initiated.
7.12.g.9. Air Kerma Rate or Absorbed Dose Rate. For equipment manufactured after July 1, 2001, a system shall be provided from whose readings the air kerma rate or absorbed dose rate at a reference point can be calculated. In addition:.
7.12.g.9.A. The dose monitor unit rate shall be displayed at the treatment control panel;
7.12.g.9.B. If the equipment can deliver under any conditions an air kerma rate or absorbed dose rate at the nominal treatment distance more than twice the maximum value specified by the manufacturer, a device shall be provided which terminates irradiation when the air kerma rate or absorbed dose rate exceeds a value twice the specified maximum. The dose rate at which the irradiation will be terminated shall be a record maintained by the registrant;
7.12.g.9.C. If the equipment can deliver under any fault condition or conditions an air kerma rate or absorbed dose rate at the nominal treatment distance more than ten (10) times the maximum value specified by the manufacturer, a device shall be provided to prevent the air kerma rate or absorbed dose rate anywhere in the radiation field from exceeding twice the specified maximum value and to terminate irradiation if the excess absorbed dose at the nominal treatment distance exceeds four (4) Gy (four hundred [400] Rad); and
7.12.g.9.D. For each therapeutic radiation machine, the registrant shall determine, or obtain from the manufacturer, the maximum values specified in 7.12.g.9.B. and 7.12.g.9.C. for the specified operating conditions. Records of these maximum values shall be maintained at the installation for inspection by the agency.
7.12.g.10. Termination of irradiation by the beam monitoring system or systems during stationary beam radiation therapy.
7.12.g.10.A. Each primary system shall terminate irradiation when the pre-selected number of dose monitor units has been detected by the system;
7.12.g.10.B. If the original design of the equipment included a secondary dose monitoring system, that system shall be capable of terminating irradiation when not more than fifteen (15) percent or forty (40) dose monitor units above the pre-selected number of dose monitor units set at the control panel has been detected by the secondary dose monitoring system; and
7.12.g.10.C. For equipment manufactured after July 1, 2001, an indicator on the control panel shall show which monitoring system has terminated irradiation.
7.12.g.11. Termination of Irradiation. It shall be possible to terminate irradiation and equipment movement or go from an interruption condition to termination condition at any time from the operator's position at the treatment control panel.
7.12.g.12. Interruption of Irradiation. If a therapeutic radiation machine has an interrupt mode, it shall be possible to interrupt irradiation and equipment movements at any time from the treatment control panel. Following an interruption it shall be possible to restart irradiation by operator action without any reselection of operating conditions. If any change is made of a pre-selected value during an interruption, irradiation and equipment movements shall be automatically terminated.
7.12.g.13. Timer. A suitable irradiation control device shall be provided to terminate the irradiation after a pre-set time interval.
7.12.g.13.A. A timer shall be provided which has a display at the treatment control panel. The timer shall have a pre-set time selector and an elapsed time indicator;
7.12.g.13.B. The timer shall be a cumulative timer that activates with an indication of "BEAM-ON" and retains its reading after irradiation is interrupted or terminated. After irradiation is terminated and before irradiation can be reinitiated, it shall be necessary to reset the elapsed time indicator;
7.12.g.13.C. The timer shall terminate irradiation when a pre-selected time has elapsed, if the dose monitoring systems have not previously terminated irradiation.
7.12.g.14. Selection of Radiation Type. Equipment capable of both x-ray therapy and electron therapy shall meet the following additional requirements:
7.12.g.14.A. Irradiation shall not be possible until a selection of radiation type (x-rays or electrons) has been made at the treatment control panel;
7.12.g.14.B. The radiation type selected shall be displayed at the treatment control panel before and during irradiation;
7.12.g.14.C. An interlock system shall be provided to ensure that the equipment can principally emit only the radiation type that has been selected;
7.12.g.14.D. An interlock system shall be provided to prevent irradiation with x-rays, except to obtain an image, when electron applicators are fitted;
7.12.g.14.E. An interlock system shall be provided to prevent irradiation with electrons when accessories specific for x-ray therapy are fitted; and
7.12.g.14.F. An interlock system shall be provided to prevent irradiation if any selected operations carried out in the treatment room do not agree with the selected operations carried out at the treatment control panel.
7.12.g.15. Selection of Energy. Equipment capable of generating radiation beams of different energies shall meet the following requirements:
7.12.g.15.A. Irradiation shall not be possible until a selection of energy has been made at the treatment control panel;
7.12.g.15.B. The nominal energy value selected shall be displayed at the treatment control panel until reset manually for the next irradiation. After termination of irradiation, it shall be necessary to reset the nominal energy value selected before subsequent treatment can be initiated;
7.12.g.15.C. Irradiation shall not be possible until the appropriate flattening filter or scattering foil for the selected energy is in its proper location; and
7.12.g.15.D. For equipment manufactured after July 1, 2001, the selection of energy shall be in compliance with International Electrotechnical Commission (IEC) Document 601-2-1.
7.12.g.16. Selection of Stationary Beam Radiation Therapy or Moving Beam Radiation Therapy. Therapeutic radiation machines capable of both stationary beam radiation therapy and moving beam radiation therapy shall meet the following requirements:
7.12.g.16.A. Irradiation shall not be possible until a selection of stationary beam radiation therapy or moving beam radiation therapy has been made at the treatment control panel;
7.12.g.16.B. The mode of operation shall be displayed at the treatment control panel;
7.12.g.16.C. An interlock system shall be provided to ensure that the equipment can operate only in the mode that has been selected;
7.12.g.16.D. An interlock system shall be provided to prevent irradiation if any selected parameter in the treatment room does not agree with the selected parameter at the treatment control panel;
7.12.g.16.E. Moving beam radiation therapy shall be controlled to obtain the selected relationships between incremental dose monitor units and incremental movement. For equipment manufactured after July 1, 2001:
7.12.g.16.E.1. An interlock system shall be provided to terminate irradiation if the number of dose monitor units delivered in any ten (10) degrees of rotation or one (1) cm of linear motion differs by more than twenty (20) percent from the selected value;
7.12.g.16.E.2. Where angle terminates the irradiation in moving beam radiation therapy, the dose monitor units delivered shall differ by less than five (5) percent from the dose monitor unit value selected;
7.12.g.16.E.3. An interlock shall be provided to prevent motion of more than five (5) degrees or one (1) cm beyond the selected limits during moving beam radiation therapy;
7.12.g.16.E.4. An interlock shall be provided to require that a selection of direction be made at the treatment control panel in all units which are capable of both clockwise and counter-clockwise moving beam radiation therapy.
7.12.g.16.E.5. Moving beam radiation therapy shall be controlled with both primary position sensors and secondary position sensors to obtain the selected relationships between incremental dose monitor units and incremental movement.
7.12.g.16.E.6. Where the beam monitor system terminates the irradiation in moving beam radiation therapy, the termination of irradiation shall be as required by Paragraph 7.12.g.10.; and
7.12.g.16.E.7. For equipment manufactured after July 1, 2001, an interlock system shall be provided to terminate irradiation if movement: 7.12.g.16.E.7.(a). Occurs during stationary beam radiation therapy; or 7.12.g.16.E.7.(b). Does not start or stops during moving beam radiation therapy unless such stoppage is a pre-planned function.
7.12.g.17. Facility Design Requirements for Therapeutic Radiation Machines Operating Above 500 kV. In addition to shielding adequate to meet requirements of 1.12.i., the following design requirements are made:
7.12.g.17.A. Protective Barriers. All protective barriers shall be fixed, except for access doors to the treatment room or movable beam interceptors;
7.12.g.17.B. Control Panel. In addition to other requirements specified in Subsection 7.12., the control panel shall also:
7.12.g.17.B.1. Be located outside the treatment room;
7.12.g.17.B.2. Provide an indication of whether electrical power is available at the control panel and if activation of the radiation is possible;
7.12.g.17.B.3. Provide an indication of whether radiation is being produced; and
7.12.g.17.B.4. Include an access control (locking) device that will prevent unauthorized use of the therapeutic radiation machine.
7.12.g.17.C. Viewing Systems. Windows, mirrors, closed-circuit television or an equivalent viewing system shall be provided to permit continuous observation of the patient following positioning and during irradiation and shall be so located that the operator may observe the patient from the treatment control panel. The therapeutic radiation machine shall not be used for patient irradiation unless at least one viewing system is operational;
7.12.g.17.D. Aural Communications. Provision shall be made for continuous two-way aural communication between the patient and the operator at the control panel. The therapeutic radiation machine shall not be used for irradiation of patients unless continuous two-way aural communication is possible;
7.12.g.17.E. Room Entrances. Treatment room entrances shall be provided with warning lights in a readily observable position near the outside of all access doors, which will indicate when the useful beam is "ON" and when it is "OFF";
7.12.g.17.F. Entrance Interlocks. Interlocks shall be provided such that all access controls are activated before treatment can be initiated or continued. If the radiation beam is interrupted by any access control, it shall not be possible to restore the machine to operation without resetting the access control and reinitiating irradiation by manual action at the control panel;
7.12.g.17.G. Beam Interceptor Interlocks. If the shielding material in any protective barrier requires the presence of a beam interceptor to ensure compliance with Subdivision 6.13.a. and Subsection 6.13.b. of this rule, interlocks shall be provided to prevent the production of radiation, unless the beam interceptor is in place, whenever the useful beam is directed at the designated barriers;
7.12.g.17.H. Emergency Cutoff Switches. At least 1 emergency power cutoff switch shall be located in the radiation therapy room and shall terminate all equipment electrical power including radiation and mechanical motion. This switch is in addition to the termination switch required by 7.12.g.11. All emergency power cutoff switches shall include a manual reset so that the therapeutic radiation machine cannot be restarted from the unit's control console without resetting the emergency cutoff switch;
7.12.g.17.I. Safety Interlocks. All safety interlocks shall be designed so that any defect or component failure in the safety interlock system prevents or terminates operation of the therapeutic radiation machine; and
7.12.g.17.J. Surveys for Residual Radiation. Surveys for residual activity shall be conducted on all therapeutic radiation machines capable of generating photon and electron energies above ten (10) MV prior to machining, removing, or working on therapeutic radiation machine components which may have become activated due to photo-neutron production.
7.12.g.18. Radiation Therapy Physicist Support.
7.12.g.18.A. The services of a radiation therapy physicist shall be required in facilities having therapeutic radiation machines with energies of five hundred (500) kV and above. The radiation therapy physicist shall be responsible for:
7.12.g.18.A.1. Full calibrations required by Paragraph 7.12.g.20. and protection surveys required by Paragraph 7.12.d.1.;
7.12.g.18.A.2. Supervision and review of dosimetry;
7.12.g.18.A.3. Beam data acquisition and transfer for computerized dosimetry, and supervision of its use;
7.12.g.18.A.4. Quality assurance, including quality assurance check review required by Subparagraph 7.12.g.21.E.
7.12.g.18.A.5. Consultation with the authorized user in treatment planning, as needed; and
7.12.g.18.A.6. Perform calculations/assessments regarding misadministrations.
7.12.g.18.B. If the radiation therapy physicist is not a full-time employee of the registrant, the operating procedures required by Subparagraph 7.12.g.24. shall also specifically address how the radiation therapy physicist is to be contacted for problems or emergencies, as well as the specific actions, if any, to be taken until the radiation therapy physicist can be contacted.
7.12.g.19. Operating Procedures.
7.12.g.19.A. No individual, other than the patient, shall be in the treatment room during treatment or during any irradiation for testing or calibration purposes;
7.12.g.19.B. Therapeutic radiation machines shall not be made available for medical use unless the requirements of 7.12.a.1., 7.12.g.20. and 7.12.21. have been met;
7.12.g.19.C. Therapeutic radiation machines, when not in operation, shall be secured to prevent unauthorized use;
7.12.g.19.D. When adjustable beam limiting devices are used, the position and shape of the radiation field shall be indicated by a light field.
7.12.g.19.E. If a patient must be held in position during treatment, mechanical supporting or restraining devices shall be used; and
7.12.g.19.F. A copy of the current operating and emergency procedures shall be maintained at the therapeutic radiation machine control console.
7.12.g.20. Acceptance testing, commissioning and full calibration measurements.
7.12.g.20.A. Acceptance testing, commissioning and full calibration of a therapeutic radiation machine subject to Subsection 7.12. shall be performed by, or under the direct supervision of, a radiation therapy physicist.
7.12.g.20.B. Acceptance testing and commissioning shall be performed in accordance with "AAPM Code of Practice for Radiotherapy Accelerators: Report of AAPM Radiation Therapy Task Group 45" and shall be conducted before the first medical use following installation or reinstallation of the therapeutic radiation machine.
7.12.g.20.C. Full calibration shall include measurement of all parameters required by Table II of "Comprehensive QA for Radiation Oncology: Report of AAPM Radiation Therapy Committee Task Group 40" and shall be performed in accordance with "AAPM Code of Practice for Radiotherapy Accelerators: Report of AAPM Radiation Therapy Task Group 45". Although it shall not be necessary to complete all elements of a full calibration at the same time, all parameters (for all energies) shall be completed at intervals not exceeding twelve (12) calendar months, unless a more frequent interval is required in Table ii.
7.12.g.20.D. The radiation therapy physicist shall perform all elements of a full calibration necessary to determine that all parameters are within acceptable limits:
7.12.g.20.D.1. Whenever quality assurance check measurements indicate that the radiation output differs by more than five (5) percent from the value obtained at the last full calibration and the difference cannot be reconciled. Therapeutic radiation machines with multi-energy or multi-mode capabilities shall only require measurements for those modes or energies that are not within their acceptable range; and
7.12.g.20.D.2. Following any component replacement, major repair, or modification of components that could significantly affect the characteristics of the radiation beam. If the repair, replacement or modification does not affect all modes or energies, measurements shall be performed on the effected mode or energy that is in most frequent clinical use at the facility. The remaining energies or modes may be validated with quality assurance check procedures against the criteria in 7.12.g.20.D.1.
7.12.g.20.E. The registrant shall maintain a record of each calibration in an auditable form for the duration of the registration. The record shall include: the date of the calibration; the manufacturer's name, model number and serial number for the therapeutic radiation machine; the model numbers and serial numbers of the instruments used to calibrate the therapeutic radiation machine; and the signature of the radiation therapy physicist responsible for performing the calibration.
7.12.g.21. Periodic Quality Assurance Checks.
7.12.g.21.A. Periodic quality assurance checks shall be performed on all therapeutic radiation machines subject to Subdivision 7.12. at intervals not to exceed those specified in "comprehensive qa for radiation oncology: report of AAPM radiation therapy committee task group 40";
7.12.g.21.B. To satisfy the requirement of Subparagraph 7.12.g.21.A., quality assurance checks shall include determination of central axis radiation output and a representative sampling of periodic quality assurance checks contained in "comprehensive qa for radiation oncology: report of AAPM radiation therapy committee task group 40". Representative sampling shall include all referenced periodic quality assurance checks in an interval not to exceed 12 consecutive calendar months;
7.12.g.21.C. The registrant shall use a dosimetry system that has been inter-compared within the previous 12 months with the dosimetry system described in Subparagraph 7.12.d.3.A. to make the periodic quality assurance checks required in Subparagraphs 7.12.g.21.B.;
7.12.g.21.D. The registrant shall perform periodic quality assurance checks required by Subparagraph 7.12.g.21.A. in accordance with procedures established by the radiation therapy physicist;
7.12.g.21.E. The registrant shall review the results of each periodic radiation output check according to the following procedures:
7.12.g.21.E.1. The authorized user and radiation therapy physicist shall be immediately notified if any parameter is not within its acceptable tolerance. The therapeutic radiation machine shall not be made available for subsequent medical use until the radiation therapy physicist has determined that all parameters are within their acceptable tolerances;
7.12.g.21.E.2. If all quality assurance check parameters appear to be within their acceptable range, the quality assurance check shall be reviewed and signed by either the authorized user or radiation therapy physicist within three (3) treatment days; and
7.12.g.21.E.3. The radiation therapy physicist shall review and sign the results of each radiation output quality assurance check at intervals not to exceed one (1) month.
7.12.g.21.F. Therapeutic radiation machines subject to Subsection 7.12. shall have safety quality assurance checks listed in "Comprehensive QA for Radiation Oncology: Report of AAPM Radiation Therapy Committee Task Group 40" performed at intervals not to exceed one (1) week;
7.12.g.21.G. To satisfy the requirement of Subparagraph 7.12.g.21.F., safety quality assurance checks shall ensure proper operation of:
7.12.g.21.G.1. Electrical interlocks at each external beam radiation therapy room entrance;
7.12.g.21.G.2. Proper operation of the "BEAM-ON", interrupt and termination switches;
7.12.g.21.G.3. Beam condition indicator lights on the access doors, control console, and in the radiation therapy room;
7.12.g.21.G.4. Viewing systems;
7.12.g.21.G.5. Electrically operated treatment room doors from inside and outside the treatment room;
7.12.g.21.G.6. At least one emergency power cutoff switch. If more than one emergency power cutoff switch is installed and not all switches are tested at once, each switch shall be tested on a rotating basis. Safety quality assurance checks of the emergency power cutoff switches may be conducted at the end of the treatment day in order to minimize possible stability problems with the therapeutic radiation machine.
7.12.g.21.H. The registrant shall promptly repair any system identified in Subparagraph 7.12.g.21.G. that is not operating properly; and
7.12.g.21.I. The registrant shall maintain a record of each quality assurance check required by Subparagraphs 7.12.g.21.A. and 7.21.g.21.G. for three (3) years. The record shall include: the date of the quality assurance check; the manufacturer's name, model number, and serial number of the therapeutic radiation machine; the manufacturer's name, model number and serial number for the instruments used to measure the radiation output of the therapeutic radiation machine; and the signature of the individual who performed the periodic quality assurance check.
7.12.h. Calibration of Survey Instruments.
7.12.h.1. The registrant shall ensure that the survey instruments used to show compliance with Subsection 7.12. have been calibrated before first use, at intervals not to exceed twelve (12) months, and following repair.
7.12.h.2. To satisfy the requirements of Paragraph 7.12.h.1., the registrant shall:
7.12.h.2.A. Calibrate all required scale readings up to ten (10) mSv (one thousand [1000] mRem) per hour with an appropriate radiation source that is traceable to the National Institute of Standards and Technology (NIST);
7.12.h.2.B. Calibrate at least two (2) points on each scale to be calibrated. These points should be at approximately one-third (1/3) and two-thirds (2/3) of full-scale; and
7.12.h.3. To satisfy the requirements of Paragraph 7.12.h.2., the registrant shall:
7.12.h.3.B. Consider a point as calibrated if the indicated dose rate differs from the calculated dose rate by not more than ten (10) percent; and
7.12.h.3.C. Consider a point as calibrated if the indicated dose rate differs from the calculated dose rate by not more than twenty (20) percent if a correction factor or graph is conspicuously attached to the instrument. 7.12.h..3.D. The registrant shall retain a record of each calibration required in Paragraph 7.12.h.1. for three (3) years. The record shall include:
7.12.h.3.D.1. A description of the calibration procedure; and
7.12.h.3.D.2. A description of the source used and the certified dose rates from the source, and the rates indicated by the instrument being calibrated, the correction factors deduced from the calibration data, the signature of the individual who performed the calibration, and the date of calibration.
7.12.h.3.E. The registrant may obtain the services of individuals registered by the agency, the US Nuclear Regulatory Commission, an agreement state, or a licensing state to perform calibrations of survey instruments. Records of calibrations that contain information required by Paragraph 7.12.h.4. shall be maintained by the registrant.
7.12.i. Shielding and Safety Design Requirements.
7.12.i.1. Each therapeutic radiation machine subject to Subdivision 7.12.g. or 7.12.h. shall be provided with such primary or secondary barriers as are necessary to ensure compliance with Subsections 6.5. and 6.13. of this rule.
7.12.i.2. Facility design information for all new installations of a therapeutic radiation machine or installations of a therapeutic radiation machine of higher energy into a room not previously approved for that energy shall be submitted for agency approval prior to actual installation of the therapeutic radiation machine. The minimum facility design information that must be submitted is contained in Table 64-23 U.
W. Va. Code R. § 64-23-8 Radiation Safety Requirements for Industrial Radiographic Operations
8.1. Purpose. The rules in this Section establish radiation safety requirements for using sources of radiation for industrial radiography. The requirements of this Section are in addition to, and not in substitution for, other applicable requirements of this rule.
8.2. Scope. The rules in this Section apply to all registrants who use sources of radiation for industrial radiography. Except for those rules of this Section clearly applicable only to sealed radioactive sources, both radiation machines and sealed radioactive sources are covered by this Section.
8.3 Definitions. As used in this Section, the following definitions apply:
8.3.1. Cabinet Radiography - industrial radiography conducted in an enclosure or cabinet shielded so that radiation levels at every location on the exterior meet the limitations specified in Subsection 6.5. of this rule.
8.3.2. Cabinet X-ray System - an x-ray system with the x-ray tube installed in an enclosure independent of existing architectural structures except the floor on which it may be placed. The cabinet x-ray system is intended to contain at least that portion of a material being irradiated, provide radiation attenuation, and exclude personnel from its interior during generation of radiation. Included are all x-ray systems designed primarily for the inspection of carry-on baggage at airline, railroad, and bus terminals, and in similar facilities. An x-ray tube used within a shielded part of a building, or x-ray equipment which may temporarily or occasionally incorporate portable shielding, is not considered a cabinet x-ray system.
8.3.3. Certified Cabinet X-ray System - an x-ray system which has been certified in accordance with 21 CFR 1010.2 as being manufactured and assembled pursuant to the provisions of 21 CFR 1020.40.
8.3.4. Collimator - a device used to limit the size, shape, and direction of the primary radiation beam.
8.3.5. Field Radiography - all industrial radiography other than cabinet radiography and shielded room radiography.
8.3.6. Industrial Radiography - the examination of the macroscopic structure of materials by nondestructive methods using sources of ionizing radiation to produce radiographic images.
8.3.7. Lixiscope - a portable light-intensified imaging device using a sealed source.
8.3.8. Permanent Radiographic Installation - an installation or structure designed or intended for radiography and in which radiography is regularly performed.
8.3.9 Personal Supervision - guidance and instruction provided to a radiographer trainee by a radiographer instructor who is present at the site, in visual contact with the trainee while the trainee is using sources of radiation, and in such proximity that immediate assistance can be given if required.
8.3.10. Radiographer - any individual who performs or personally supervises industrial radiographic operations and who is responsible to the registrant for assuring compliance with the requirements of this rule and all certificate of registration conditions.
8.3.11. Radiographer Instructor - any radiographer who has been authorized by the agency to provide on-the-job training to radiographer trainees in accordance with Paragraph 8.14.b.2.
8.3.12. Radiographer Trainee - any individual who, under the personal supervision of a radiographer instructor, uses sources of radiation, related handling tools, or radiation survey instruments during the course of his instruction.
8.3.13. Radiographic Exposure Device - any instrument containing a sealed source fastened or contained therein, in which the sealed source or shielding thereof may be moved, or otherwise changed, from a shielded to unshielded position for purposes of making a radiographic exposure.
8.3.14. Radiographic Personnel - any radiographer, radiographer instructor, or radiographer trainee.
8.3.15. Residential Location - any area where structures in which people lodge or live are located, and the grounds on which such structures are located including, but not limited to, houses, apartments, condominiums, and garages.
8.3.16. Shielded Position - the location within the radiographic exposure device or storage container which, by manufacturer's design, is the proper location for storage of the sealed source.
8.3.17. Shielded Room Radiography - industrial radiography which is conducted in an enclosed room, the interior of which is not occupied during radiographic operations, which is so shielded that every location on the exterior meets the limitations specified in Subsection 6.5. of this rule and the only access to which is through openings which are interlocked so that the radiation machine will not operate unless all openings are securely closed.
8.3.18. Source Changer - a device designed and used for replacement of sealed sources in radiographic exposure devices, including those source changers also used for transporting and storage of sealed sources.
8.3.19. Storage Area - any location, facility, or vehicle which is used to store, to transport, or to secure a radiographic exposure device, a storage container, or a sealed source when it is not in use and which is locked or has a physical barrier to prevent accidental exposure, tampering with, or unauthorized removal of the device, container, or source.
8.3.20. Storage Container - a device in which sealed sources are transported or stored.
8.3.21. Temporary Job Site - any location where industrial radiography is performed other than the location or locations listed in a specific registration or certificate of registration.
8.3.22. Transport Container - a package that is designed to provide radiation safety and security when sealed sources are transported and which meets all applicable requirements of the U.S. Department of Transportation.
8.4. Exemptions
8.4.a. Except for the requirements of Subdivision 8.22.b. and c., certified cabinet x-ray systems designed to exclude individuals from the interior of the cabinet are exempt from the requirements of this Section.
8.4.b. Industrial uses of lixiscopes are exempt from the requirements in this Section.
8.5. Limits on Radiation Levels for Radiography Exposure Devices and Storage Containers
8.5.a. Radiographic exposure devices measuring less than four (4) inches ten (10) cm from the sealed source storage position to any exterior surface of the device shall have no radiation level in excess of fifty (50) milliroentgens (one and twenty nine one hundred thousandths [1.29 x 10-5 ] C/kg) per hour at six (6) inches fifteen (15cm) from any exterior surface of the device. Radiographic exposure devices measuring a minimum of four (4) inches from the sealed source storage position to any exterior surface of the device, and all storage containers for sealed sources or outer containers for radiographic exposure devices, shall have no radiation level in excess of two hundred (200) milliroentgens per hour at any exterior surface, The radiation levels specified are with the sealed source in the shielded position.
8.5.b. Radiographic exposure devices measuring a minimum of four (4) inches ten (10) cm from the sealed source storage position to any exterior surface of the device, and all storage containers for sealed sources or outer containers for radiographic exposure devices, shall have no radiation level in excess of two hundred (200) milliroentgens (five and sixteen one hundred thousandths [5.16 x 10-5 ] C/kg) per hour at any exterior surface, and ten (10 ) milliroentgens (two and fifty eight one millionth [2.58 x 10-6] C/kg) per hour at thirty nine and four-tenths (39.4) inches (one [1] m) from any exterior surface. The radiation levels specified are with the sealed source in the shielded (i.e., "off") position.
8.6. Locking of Sources of Radiation - Each source of radiation shall be provided with a lock or outer lockable container designed to prevent unauthorized or accidental production of radiation or removal or exposure of a sealed source and shall be kept locked at all times except when under the direct surveillance of a radiographer or radiographer's assistant, or as may be otherwise authorized pursuant to Subdivision 8.18.a. Each storage container likewise shall be provided with a lock and kept locked when containing sealed sources except when the container is under the direct surveillance of a radiographer or radiographer's trainee.
8.6.a. Radiographic exposure devices, source changers, and storage containers, prior to being moved from one location to another and also prior to being secured at a given location, shall be locked and surveyed to assure that the sealed source is in the shielded position.
8.6.b. The sealed source shall be secured in its shielded position by locking the exposure device or securing the remote control each time the sealed source is returned to its shielded position. Then a survey shall be performed to determine that the sealed source is in the shielded position pursuant to Subdivision 8.19.b.
8.7. Storage Precautions
8.7.a. Locked radiographic exposure devices source changers, storage containers, and radiation machines shall be physically secured to prevent tampering or removal by unauthorized personnel.
8.7.b. Radiographic exposure devices, source changers, or transport containers that contain radioactive material shall not be stored in residential locations. This requirement does not apply to storage of radioactive material in a vehicle in transit for use at temporary job sites, if the registrant complies with Subdivision 8.7.c., and if the vehicle does not constitute a permanent storage location as described in 8.7.d.
8.7.c. If a vehicle is to be used for storage of radioactive material, a vehicle survey shall be performed after securing radioactive material in the vehicle and before transport to ensure that radiation levels do not exceed the limits specified in Subsection 6.5. of this rule at the exterior surface of the vehicle.
8.7.d. A storage or use location is permanent if radioactive material is stored at the location for more than ninety (90) days and any one or more of the following applies to the location:
8.7.d.1. Telephone service is established by the registrant;
8.7.d.2. Industrial radiographic services are advertised for or from the location;
8.7.d.3. Industrial radiographic operations are conducted at other sites due to arrangements made from the location.
8.8. Radiation Survey Instruments - The registrant shall maintain sufficient calibrated and operable radiation survey instruments to make physical radiation surveys as required by this Section and Section 12 of this rule. Instrumentation required by this Section shall have a range such that two (2) milliroentgens (five and sixteen billionths [5.16 x 10-7] C/kg) per hour through one (1) Roentgen (two and fifty-eight ten thousandths [2.58 x 10-4] C/kg) per hour can be measured.
8.8.a. The registrant shall maintain sufficient calibrated and operable radiation survey instruments to make physical radiation surveys as required by this Section and Subsection 6.5. of this rule. Instrumentation required by this Section shall have a range such that two (2) milliroentgens (five and sixteen billionths [5.16 x 10-7] C/kg) per hour through 1 Roentgen (two and fifty-eight ten thousandths [2.58 x 10-4 ] C/kg) per hour can be measured.
8.8.b. Each radiation survey instrument shall be calibrated:
8.8.b.1. At energies appropriate for use and at intervals not to exceed three (3) months and after each instrument servicing;
8.8.b.2. Such that accuracy within plus or minus twenty (20) percent can be demonstrated; and
8.8.b.3. At 2 points located approximately one-third (a) and two-thirds (b) of full-scale on each scale for linear scale instruments; at midrange of each decade, and at two (2) points of at least one (1) decade for logarithmic scale instruments; and at appropriate points for digital instruments.
8.8.c. Records of these calibrations shall be maintained for two (2) years after the calibration date for inspection by the agency.
8.8.d. Each radiation survey instrument shall be checked with a radiation source at the beginning of each day of use and at the beginning of each work shift to ensure it is operating properly.
8.9. Leak Testing, Repair, Tagging, Opening, Modification, and Replacement of Sealed Sources
8.9.a. The replacement of any sealed source fastened to or contained in a radiographic exposure device and leak testing, repair, tagging, opening, or any other modification of any sealed source shall be performed only by persons specifically authorized to do so by the agency, the U.S. Nuclear Regulatory Commission, or any agreement state.
8.9.b. Each sealed source shall be tested for leakage at intervals not to exceed six (6) months. In the absence of a certificate from a transferor that a test has been made within the six-month period prior to the transfer, the sealed source shall not be put into use until tested.
8.9.c. The leak test shall be capable of detecting the presence of five one-thousandths (0.005) microcurie (one hundred eighty five [185] Bq) of removable contamination on the sealed source. An acceptable leak test for sealed sources in the possession of a radiography registrant would be to test at the nearest accessible point to the sealed source storage position or other appropriate measuring point by a procedure to be approved by the agency. The applicant who desires to conduct his own leak test shall establish adequate procedures to be followed in leak testing sealed sources for possible leakage and contamination and shall submit to the agency a description of such procedures including:
8.9.c.1. Instrumentation to be used;
8.9.c.2. Method of performing tests, e.g., points on equipment to be smeared and methods of taking smear; and
8.9.c.3. Pertinent experience of the person who will perform the test.
8.9.d. Records of leak test results shall be kept in units of microcuries (Becquerels) and maintained for inspection by the agency.
8.9.e. Any test conducted pursuant to Subdivisions 8.9.b. and c. of this part which reveals the presence of five one-thousandths [0.005] microcurie (one hundred eighty five [185] Bq) or more of removable radioactive material shall be considered evidence that the sealed source is leaking. The registrant shall immediately withdraw such defective equipment from use and shall cause it to be decontaminated and repaired or to be disposed of, in accordance with rules of the agency. Within five (5) days after obtaining results of the test, the registrant shall file a report with the agency describing the equipment involved, the test results, and the corrective action taken.
8.9.f. Each radiographic exposure device shall have permanently attached to it a durable tag at least one (1) inch square bearing the prescribed radiation caution symbol in conventional colors, magenta or purple on a yellow background, and at least the instructions: "Danger--Radioactive Material--Do Not Handle-Notify Civil Authorities if Found."
8.10. Quarterly Inventory - Each registrant shall conduct a quarterly physical inventory to account for all sources of radiation received or possessed by him. The records of the inventories shall be maintained for two (2) years from the date of the inventory for inspection by the agency and shall include the quantities and kinds of radioactive material, the location of all sources of radiation, the date of the inventory, the name of the individual making the inventory, the manufacturer, the model and the serial number.
8.11. Utilization Logs - Each registrant shall maintain current logs, which shall be kept available for inspection by the agency for two (2) years from the date of the recorded event, showing for each source of radiation the following information:
8.11.a. A unique identification, such as a serial number, of each radiation machine, each radiographic exposure device in which a sealed source is located and each sealed source;
8.11.b. The identity of the radiographer to whom assigned;
8.11.c. Locations where used and date or dates each source of radiation was removed from storage and returned to storage; and
8.11.d. The voltage, current, and exposure time for each radiographic exposure employing a radiation machine.
8.12. Inspection and Maintenance
8.12.a. Each registrant shall ensure that checks for obvious defects in radiation machines, radiographic exposure devices, storage containers, and source changers are performed prior to each day or shift of use.
8.12.b. Each registrant shall conduct a program of at least quarterly inspection and maintenance of radiation machines, radiographic exposure devices, storage containers, and source changers to assure proper functioning of components important to safety. All appropriate parts shall be maintained in accordance with manufacturer's specifications. Records of inspection and maintenance shall be maintained for inspection by the agency for two (2) years from the date of the recorded event.
8.12.c. If any inspection conducted pursuant to Subdivisions 8.12.a or b. reveals damage to components critical to radiation safety, the device shall be removed from service and labeled as defective until repairs have been made.
8.13. Permanent Radiographic Installations. Permanent radiographic installations having high radiation area entrance controls of the type described in Subsection 6.19. of this rule shall also meet the following requirements:
8.13.a. Each entrance that is used for personnel access to the high radiation area shall have both visible and audible warning signals to warn of the presence of radiation. The visible signal shall be activated by radiation. The audible signal shall be activated when an attempt is made to enter the installation while the source is exposed.
8.13.b. The control device or alarm system shall be tested for proper operation at the beginning of each day of equipment use. If a control device or alarm system is operating improperly, it shall be immediately labeled as defective and repaired before industrial radiographic operations are resumed. Records of these tests shall be maintained for inspection by the agency for two (2) years from the date of the event.
8.14. Personal Radiation Safety Requirements for Radiographic Personnel
8.14.a. Training and Testing
8.14.a.1. No registrant shall permit any individual to act as a radiographer trainee unless such individual has received copies of, instructions in, and has demonstrated an understanding of:
8.14.a.1.A. The subjects outlined in Table 64-23 X;
8.14.a.1.B. The rules contained in this Section and the applicable Sections of 6,13 and 14 of this rule;
8.14.a.C. The appropriate registration or certificate of registration; and
8.14.a.D. The registrant's operating and emergency procedures.
8.14.b. No registrant shall permit any individual to act as a radiographer, as defined in this Section, until such individual:
8.14.b.1. Has met the requirements of Paragraph 8.14.a.1.;
8.14.b.2. Has provided the agency with documentation on agency form r or equivalent showing completion of at least thirty (30) days of on-the-job training by a radiographer instructor as a radiographer trainee following completion of the requirements of Paragraph 8.14.a.1.;
8.14.b.3. has demonstrated competence in the use of sources of radiation, radiographic exposure devices, related handling tools, and radiation survey instruments which may be employed in industrial radiographic assignments; and
8.14.b.4. has demonstrated an understanding of the instructions in Paragraph 8.14.a.1. by successful completion of a written test and a field examination on the subjects covered.
8.14.b.5 has successfully completed an examination administered by the agency or its agent.
8.14.c. Records of the above training, including copies of written tests and dates of oral tests and field examinations, shall be maintained by the registrant for inspection by the agency for three (3) years following termination of employment.
8.14.d. Each registrant shall conduct an internal audit program to ensure that the agency's radioactive material registration conditions and the registrant's operating and emergency procedures are followed by each radiographer. These internal audits shall be performed at least quarterly, and each radiographer shall be audited at least quarterly. Records of internal audits shall be maintained for inspection by the agency for two (2) years from the date of the audit.
8.15. Operating and Emergency Procedures - The registrant's operating and emergency procedures shall include instructions in at least the following:
8.15.a. The handling and use of sources of radiation to be employed such that no person is likely to be exposed to radiation doses in excess of the limits established in Section 6.;
8.15.b. Methods for controlling access to radiographic areas;
8.15.c. Methods and occasions for conducting radiation surveys;
8.15.d. Methods and occasions for locking and securing sources of radiation;
8.15.e. Personnel monitoring and the use of personnel monitoring equipment, including steps that must be taken immediately by radiography personnel in the event a pocket dosimeter is found to be off-scale;
8.15.f. Transportation to field locations, including packing of sources of radiation in the vehicles, posting of vehicles, and control of sources of radiation during transportation;
8.15.g. Minimizing exposure of persons in the event of an accident;
8.15.h. The procedure for notifying proper persons in the event of an accident; and
8.15.i. Maintenance of records.
8.15.j. The inspection and maintenance of radiographic exposure devices, source changers, storage containers, and radiation machines.
8.16. Personnel Monitoring Control
8.16.a. No registrant shall permit any person to act as a radiographer or as a radiographer's trainee unless, at all times during radiographic operations, each such person shall wear a film badge or thermoluminescent dosimeter (TLD) and a direct reading pocket dosimeter. Pocket dosimeters shall be capable of measuring exposures from zero (0) to at least two hundred (200) milliroentgens (five and sixteen one hundred thousandths [5.16 x 10-5] C/kg) and shall be recharged daily or at the start of each shift. Each film badge or TLD shall be assigned to and worn by only one person.
8.16.b. Pocket dosimeters shall be read and exposures recorded daily. A film badge or TLD shall be immediately processed if a pocket chamber or pocket dosimeter is discharged beyond its range.
8.16.c. Pocket dosimeters shall be checked for correct response to radiation at periods not to exceed one (1) year. Acceptable dosimeters shall read within plus or minus thirty (30) percent of the true radiation exposure. Records of this check shall be maintained for inspection by the agency for two (2) years from the date of the event.
8.16.d. If an individual's pocket dosimeter is discharged beyond its range, industrial radiographic operations by that individual shall cease and the individual's film badge or TLD shall be processed immediately. The individual shall not return to work with sources of radiation until a determination of the radiation exposure has been made.
8.16.e. Reports received from the film badge or TLD processor and records of daily pocket dosimeter readings shall be kept for inspection by the agency until the agency authorizes disposition.
8.16.f. If a film badge or TLD is lost or damaged, the worker shall cease work immediately until a replacement film badge or TLD is provided and the exposure is calculated for the time period from issuance to loss or damage of the film badge or TLD.
8.17. Supervision of Radiographer Trainee. Whenever a radiographer trainee uses radiographic exposure devices, sealed sources or related source handling tools, or conducts radiation surveys required by Subdivisions 8.19.b. and c. to determine that the sealed source has returned to the shielded position after an exposure, the radiographer trainee shall be under the personal supervision of a radiographer instructor.
8.18. Precautionary Procedures in Radiographic Operations
8.18.a. Security. During each radiographic operation, the radiographer, radiographer instructor or radiographer trainee shall maintain a direct surveillance of the operation to protect against unauthorized entry into a high radiation area, as defined in Section 6. of this rule, except:
8.18.a.1. Where the high radiation area is equipped with a control device or alarm system as described in Subsection 6.19. of this rule, or
8.18.a.2. Where the high radiation area is locked to protect against unauthorized or accidental entry.
8.18.b. Posting. Areas in which radiography is being performed shall be conspicuously posted as required by Subdivision 6.2. of this rule.
8.19. Radiation Surveys and Survey Records
8.19.a. No radiographic operation shall be conducted unless calibrated and operable radiation survey instrumentation, as described in Subsection 8.8., is available and used at each site where radiographic exposures are made.
8.19.b. A survey with a radiation survey instrument shall be made after each radiographic exposure to determine that the sealed source has been returned to its shielded position. The entire circumference of the radiographic exposure device shall be surveyed. If the radiographic exposure device has a source guide tube, the survey shall also include the entire length of the guide tube.
8.19.c. A survey shall be made of the storage area as defined in Subdivision 8.5.a. whenever a radiographic exposure device is being placed in storage.
8.19.d. A physical radiation survey, as specified in Subsection 8.6., shall be made to determine that each sealed source is in its shielded position prior to securing the radiographic exposure device, storage container, or source changer in a storage area as defined in Subdivision 8.5.a.
8.19.e. A physical radiation survey shall be made after each radiographic exposure using radiation machines to determine that the machine is "off".
8.19.f. Records shall be kept of the surveys required by Subdivisions 8.19.c and d. Such records shall be maintained for inspection by the agency for two (2) years after completion of the survey. If the survey was used to determine an individual's exposure, however, the records of the survey shall be maintained until the agency authorizes their disposition.
8.20. Documents and Records Required at Temporary Job sites. Each registrant conducting industrial radiography at a temporary jobsite shall have the following records available at that site for inspection by the agency:
8.20.a. Appropriate registration or certificate of registration or equivalent document;
8.20.b. Operating and emergency procedures;
8.20.c. Applicable rules;
8.20.d. Survey records required pursuant to Subsection 8.19. and area survey records required pursuant to Subdivision 6.15.a. of this rule for the period of operation at the site;
8.20.e. Daily pocket dosimeter records for the period of operation at the site; and
8.20.f. The latest instrument calibration and leak test records for specific devices and sealed sources in use at the site. Acceptable records include tags or labels which are affixed to the device or survey meter.
8.21. Specific Requirements for Radiographic Personnel Performing Industrial Radiography
8.21.a. At a jobsite, the following shall be supplied by the registrant:
8.21.a.1. At least one operable, calibrated survey instrument;
8.21.a.2. A current whole body personnel monitor (TLD or film badge) for each individual;
8.21.a.3. An operable, calibrated pocket dosimeter with a range of zero (0) to two hundred (200) milliroentgens (five and sixteen one hundred thousandths [5.16 x 10-5] C/kg) for each worker; and
8.21.a.4. The appropriate barrier ropes and signs.
8.21.b. Industrial radiographic operations shall not be performed if any of the items in Subdivision 8.20.a. are not available at the jobsite or are inoperable.
8.21.c. Each registrant shall provide as a minimum two (2) radiographic personnel when sources of radiation are used at temporary job sites. If one of the personnel is a radiographer trainee, the other shall be a radiographer instructor.
8.21.d. No individual other than a radiographer or a radiographer trainee who is under the personal supervision of a radiographer instructor shall manipulate controls or operate equipment used in industrial radiographic operations.
8.21.e. No individual shall act as a radiographer instructor unless such individual:
8.21.e.1. Has met the requirements of 8.14.a..;
8.21.e.2. Has 1 year of documented experience as a radiographer; and
8.21.e.3. Has been named as a radiographer instructor on the registration or registration certificate issued by the agency.
8.21.f. During an inspection by the agency, the agency inspector may terminate an operation if any of the items in Subdivision 8.21.a. are not available and operable or if the required number of radiographic personnel are not present. Operations shall not be resumed until such conditions are met.
8.22. Special Requirements and Exemptions for Cabinet Radiography
8.22.a. Systems for cabinet radiography designed to allow admittance of individuals shall:
8.22.a.1. Comply with all applicable requirements of this Section and Subsection 6.5. of this rule. If such a system is a certified cabinet x-ray system, it shall comply with all applicable requirements of this Section and 21 CFR 1020.40.
8.22.a.2. Be evaluated at intervals not to exceed 1 year to assure compliance with the applicable requirements as specified in Paragraph 8.21.a.1. Records of these evaluations shall be maintained for inspection by the agency for a period of two (2) years after the evaluation.
8.22.b. Certified cabinet x-ray systems designed to exclude individuals from the interior of the cabinet are exempt from the requirements of this Section except that:
8.22.b.1. Operating personnel must be provided with either a film badge or a thermoluminescent dosimeter, and reports of the results shall be maintained for inspection by the agency.
8.22.b.2. No registrant shall permit any individual to operate a cabinet x-ray system until such individual has received a copy of and instruction in the operating procedures for the unit and has demonstrated competence in its use. Records which demonstrate compliance with this Subparagraph shall be maintained for inspection by the agency until disposition is authorized by the agency.
8.22.b.3. Tests for proper operation of high radiation area control devices or alarm systems, where applicable, shall be conducted, recorded, and maintained in accordance with Subsection 8.13.
8.22.b.4. The registrant shall perform an evaluation, at intervals not to exceed one (1) year, to determine conformance with Subsection 6.5. of this rule. If such a system is a certified cabinet x-ray system, it shall be evaluated at intervals not to exceed one (1) year to determine conformance with 21 CFR 1020.40. Records of these evaluations shall be maintained for inspection by the agency for a period of two (2) years after the evaluation.
8.22.c. Certified cabinet x-ray systems shall be maintained in compliance with 21 CFR 1020.40 unless prior approval has been granted by the agency pursuant to Subsection 4.1. of this rule.
8.23. Prohibitions. Industrial radiography performed with a sealed source which is not fastened to or contained in a radiographic exposure device, known as fishpole radiography, is prohibited unless specifically authorized in a registration issued by the agency.
W. Va. Code R. § 64-23-9 Radiation Safety Requirements for Analytical X-Ray Equipment
9.1. Scope - This Section provides special requirements for analytical x-ray equipment. The requirements of this Section are in addition to, and not in substitution for applicable requirements in other Sections of this rule.
9.2. Definitions
9.2.1. Analytical X-ray Equipment - equipment used for x-ray diffraction of fluorescence analysis.
9.2.2. Analytical X-ray System - a group of components utilizing x-ray to determine the elemental composition or to examine the microstructure of materials.
9.2.3. Fail-safe Characteristics - a design feature which causes beam port shutters to close, or otherwise prevents emergency of the primary beam, upon the failure of a safety or warning device.
9.2.4. Local Components - part of an analytical x-ray system and includes areas that are struck by x-rays such as radiation source housings, port and shutter assemblies, collimators, sample holders, cameras, goniometers, detectors and shielding, but do not include power supplies, transformers, amplifiers, readout devices, and control panels.
9.2.5. Normal Operating Procedures - step-by-step instructions necessary to accomplish the analysis. These procedures shall include sample insertion and manipulation, equipment alignment, routine maintenance by the registrant, and data recording procedures which are related to radiation safety.
9.2.6. Open-beam Configuration - an analytical x-ray system in which an individual could accidently place some part of his body in the primary beam path during normal operation.
9.2.7. Primary Beam - radiation which passes through an aperture of the source housing by a direct path from the x-ray tube or a radioactive source located in the radiation source housing.
9.3. General Regulatory Provisions and Specific Requirements
9.3.a. Equipment Requirements
9.3.a.1. Safety Device - A device which prevents the entry of any portion of an individual's body into the primary x-ray beam path or which causes the beam to be shut off upon entry into its path shall be provided on all open-beam configurations. A registrant may apply to the agency for an exemption from the requirement of a safety device. Such application shall include:
9.3.a.1.A. A description of the various safety devices that have been evaluated;
9.3.a.1.B. The reason each of these devices cannot be used; and
9.3.a.1.C. A description of the alternative methods that will be employed to minimize the possibility of an accidental exposure, including procedures to assure that operators and others in the area will be informed of the absence of safety devices.
9.3.b. Warning Devices
9.3.b.1. Open-beam configurations shall be provided with a readily discernible indication of:
9.3.b.1.A. X-ray tube status (ON-OFF) located near the radiation source housing, if the primary beam is controlled in this manner; or
9.3.b.1.B. Shutter status (OPEN-CLOSED) located near each port on the radiation source housing, if the primary beam is controlled in this manner.
9.3.b.2. Warning devices shall be labeled so that their purpose is easily identified. On equipment installed after the effective date of this rule, warning devices shall have fail-safe characteristics.
9.3.c. Ports - Unused ports on radiation source housings shall be identified in the closed position in a manner which will prevent casual opening.
9.3.d. Labeling - All analytical x-ray equipment shall be labeled with a readily discernible sign or signs bearing the radiation symbol and the words:
9.3.d.1. "CAUTION - HIGH INTENSITY X-RAY BEAM," or words having a similar intent, on the x-ray housing; and
9.3.d.2. "CAUTION RADIATION - THIS EQUIPMENT PRODUCES RADIATION WHEN ENERGIZED," or words having a similar intent, near any switch that energizes an x-ray tube if the radiation source is an x-ray tube; or "CAUTION - RADIOACTIVE MATERIAL," or words having a similar intent, on the source housing if the radiation source is a radionuclide.
9.3.e. Shutters - On open-beam configurations installed after the effective date of this rule, each port on the radiation source housing shall be equipped with a shutter that cannot be opened unless a collimator or a coupling has been connected to the port.
9.3.f. Warning Lights
9.3.f.1. An easily visible warning light labeled with the words "X-RAY ON", or words having a similar intent, shall be located:
9.3.f.1.A. Near any switch that energizes an x-ray tube and shall be illuminated only when the tube is energized; or
9.3.f.1.B. In the case of a radioactive source, near any switch that opens a housing shutter, and shall be illuminated only when the shutter is open.
9.3.f.2. On equipment installed after the effective date of this rule, warning lights shall have fail-safe characteristics.
9.3.g. Radiation Source Housing - Each x-ray tube housing shall be so constructed that, with all shutters closed, the leakage radiation measured at a distance of five (5) cm from its surface is not capable of producing a dose in excess of two and five-tenths (2.5) mRem in one (1) hour at any specified tube rating.
9.3.h. Generator Cabinet - Each x-ray generator shall be supplied with a protective cabinet which limits leakage radiation measured at a distance of five (5) cm from its surface such that it is not capable of producing a dose in excess of twenty five one-hundredths (0.25) mRem in one (1) hour.
9.4. Area Requirements
9.4.a. Radiation Levels - The local components of an analytical x-ray system shall be located and arranged and shall include sufficient shielding or access control such that no radiation levels exist in any area surrounding the local component group which could result in a dose to an individual present therein in excess of the dose limits given in Subsection 6.5. of this rule. For systems utilizing x-ray tubes, these levels shall be met at any specified tube rating.
9.4.b. Surveys
9.4.b.1. Radiation surveys, as required by Subsection 6.5. of this rule, of all analytical x-ray systems sufficient to show compliance with Subdivision 9.4.a. shall be performed:
9.4.b.1.A. Upon installation of the equipment and at least once every twelve (12) months thereafter;
9.4.b.1.B. Following any change in the initial arrangement, number, or type of local components in the system;
9.4.b.1.C. Following any maintenance requiring the disassembly or removal of a local component in the system;
9.4.b.1.D. During the performance of maintenance and alignment procedures if the procedures require the presence of a primary x-ray beam when any local component in the system is disassembled or removed;
9.4.b.1.E. Any time a visual inspection of the local components in the system reveals an abnormal condition; and
9.4.b.1.F. Whenever personnel monitoring devices show a significant increase over the previous monitoring period or the readings are approaching the limits specified in Subsection 6.4. of this rule.
9.4.b.2. Radiation survey measurements shall not be required if a registrant can demonstrate compliance to the satisfaction of the agency with Subdivision 9.4.a. in some other manner.
9.4.c. Posting - Each area or room containing analytical x-ray equipment shall conspicuously posted with a sign or signs bearing the radiation symbol and the words "CAUTION - X-RAY EQUIPMENT" or words having a similar intent.
9.5. Operating Requirements
9.5.a. Procedures - Normal operating procedures shall be written and available to all analytical x-ray equipment workers. No person shall be permitted to operate analytical x-ray equipment in any manner other than that specified in the procedures unless such person has obtained written approval of the radiation safety officer.
9.5.b. Bypassing - No person shall bypass a safety device unless such person has obtained the approval of the radiation safety officer. Such approval shall be for a specified period of time. When a safety device has been bypassed, a readily discernible sign bearing the words "SAFETY DEVICE NOT WORKING," or words having a similar intent, shall be placed on the radiation source housing.
9.5.c. Repair or Modification of X-Ray Tube Systems. Except as specified in Subdivision 9.5.b., no operation involving removal of covers, shielding materials or tube housings or modifications to shutters, collimators, or beam stops shall be performed without ascertaining that the tube is off and will remain off until safe conditions have been restored. The main switch, rather than interlocks, shall be used for routine shutdown in preparation for repairs.
9.5.d. Radioactive Source Replacement, Testing, or Repair. Radioactive source housings shall be opened for source replacement, leak testing, or other maintenance or repair procedures only by individuals authorized to specifically conduct such procedures under a registration issued by the U.S. Nuclear Regulatory Commission (NRC), an agreement state, or a licensing state.
9.6. Personnel Requirements
9.6.a. Instruction - No person shall be permitted to operate or maintain analytical x-ray equipment unless such person has received instruction in and demonstrated competence as to:
9.6.a.1. Identification of radiation hazards associated with the use of the equipment;
9.6.a.2. Significance of the various radiation warning and safety devices incorporated into the equipment, or the reasons they have not been installed on certain pieces of equipment and the extra precautions required in such cases;
9.6.a.3. Proper operating procedures for the equipment;
9.6.a.4. Symptoms of an acute localized exposure; and
9.6.a.5. Proper procedures for reporting an actual or suspected exposure.
9.6.b. Personnel Monitoring
9.6.b.1. Finger or wrist dosimetric devices shall be provided to and shall be used by:
9.6.b.1.A. Analytical x-ray equipment workers using systems having an open-beam configuration and not equipped with a safety device; and
9.6.b.1.B. Personnel maintaining analytical x-ray equipment if the maintenance procedures require the presence of a primary x-ray beam when any local component in the analytical x-ray system is disassembled or removed.
9.6.b.2. Reported dose values shall not be used for the purpose of determining compliance with Subsection 6.4. of this rule unless evaluated by a qualified expert.
W. Va. Code R. § 64-23-10 Radiation Safety Requirements for Particle Accelerators
10.1. Purpose and Scope
10.1.a. This Section establishes procedures for the registration and use of particle accelerators.
10.1.b. In addition to the requirements of this Section, all registrants are subject to the requirements of Sections 1, 5, 6, 11 and 13 Subsections 13.5., 13.6. and 13.7. of this rule. Registrants engaged in industrial radiographic operations are subject to the requirements of Subsection 8.16. of this rule and registrants engaged in the healing arts are subject to the requirements of Sections 7. and 12. Subsection 11.7. and 11.8. of this rule. Registrants whose operations result in the production of radioactive material are subject to the requirements of Section 11. of this rule.
10.2. Registration Procedure
10.2.a. Registration Requirements - No person shall receive, possess, use, transfer, own or acquire a particle accelerator unless such is in compliance with the registration requirements in Section 5. of this rule.
10.3. General Requirements for the Use of Particle Accelerators. In addition to the requirements set forth in Sections 5. or 11. Subsection 3., a registration for the use of a particle accelerator will not be issued unless the agency determines that:
10.3.a. The applicant is qualified by reason of training and experience to use the accelerator in question for the purpose intended in accordance with this Section and Sections 6. and 13. of this rule in such a manner as to minimize danger to public health and safety or property;
10.3.b. The applicant's proposed equipment, facilities, and operating and emergency procedures are adequate to protect health and minimize danger to public health and safety or property;
10.3.c. The issuance of the registration will not be inimical to the health and safety of the public, and the applicant satisfies any applicable special requirement in Subsection 11.4. of this rule;
10.3.d. The applicant has appointed a radiation safety officer;
10.3.e. The applicant or his staff has substantial experience in the use of particle accelerators for the intended use;
10.3.f. The applicant has established a radiation safety committee to approve, in advance, proposals for use of particle accelerators, whenever deemed necessary by the agency; and
10.3.g. The applicant has an adequate training program for particle accelerator operators.
10.4. Human Use of Particle Accelerators. In addition to the requirements set forth in Section 5., a registration for use of a particle accelerator in the healing arts will be issued only if:
10.4.a. Whenever deemed necessary by the agency, the registrant has appointed a medical committee of at least three (3) members to evaluate all proposals for research, diagnostic, and therapeutic use of a particle accelerator. Membership of the committee shall include physicians expert in internal medicine, hematology, therapeutic radiology and a person experienced in depth dose calculations and protection against radiation;
10.4.b. The individuals designated on the application as the users have substantial training and experience in deep therapy techniques or in the use of particle accelerators to treat humans; and
10.4.c. The individual designated on the application as the user must be a physician.
10.5. Radiation Safety Requirements for the Use of Particle Accelerators
10.5.a. General Provisions
10.5.a.1. This Subsection establishes radiation safety requirements for the use of particle accelerators which are in addition to, and not in substitution for, other applicable provisions of this rule.
10.5.a.2. The registrant shall be responsible for assuring that all requirements of this Section are met.
10.6. Limitations
10.6.a. No registrant shall permit any person to act as a particle accelerator operator until such person:
10.6.a.1. Has been instructed in radiation safety and shall have demonstrated an understanding thereof:
10.6.a.2. Has received copies of and instruction in this part and the applicable requirements of Sections 6. and 13., pertinent registration conditions and the registrants's operating and emergency procedures, and
10.6.a.3. Has demonstrated competence to use the particle accelerator, related equipment, and survey instruments which will be employed in his assignment.
10.6.b. Either the radiation safety committee or the radiation safety officer shall have the authority to terminate the operations at a particle accelerator facility if such action is deemed necessary to protect health and minimize danger to public health and safety or property.
10.7. Shielding and Safety Design Requirements
10.7.a. A qualified expert specifically accepted by the agency shall be consulted in the design of the particle accelerator installation and called upon to perform a radiation survey when the accelerator is first capable of producing radiation.
10.7.b. Each particle accelerator installation shall be provided with such primary and or secondary barriers as are necessary to assure compliance with Subsections 6.2. and 6.3.
10.8. Particle Accelerator Controls and Interlock Systems
10.8.a. Instrumentation, readouts, and controls on the particle accelerator control console shall be clearly identified and easily discernible.
10.8.b. All entrances into a target room or other high radiation area shall be provided with interlocks that shut down the machine under conditions of barrier penetration.
10.8.c. When an interlock system has been tripped, it shall only be possible to resume operation of the accelerator by manually resetting controls at the position where the interlock has been tripped, and lastly at the main control console.
10.8.d. Each safety interlock shall be on a circuit which shall allow its operation independently of all other safety interlocks.
10.8.e. All safety interlocks shall be fail safe, i.e., designed so that any defect or component failure in the interlock system prevents operation of the accelerator.
10.8.f. A scram button or other emergency power cutoff switch shall be located and easily identifiable in all high radiation areas. Such a cutoff switch shall include a manual reset so that the accelerator cannot be restarted from the accelerator control console without resetting the cutoff switch.
10.9. Warning Devices
10.9.a. All locations designated as high radiation areas, and entrances to such locations shall be equipped with easily observable flashing or rotating warning lights that operate when, and only when, radiation is being produced.
10.9.b. Except in facilities designed for human exposure, each high radiation area shall have any audible warning device which shall be activated for fifteen (15) seconds prior to the possible creation of such high radiation area. Such warning device shall be clearly discernible in all high radiation areas and all radiation areas.
10.9.c. Barriers, temporary or otherwise, and pathways leading to high radiation areas shall be identified in accordance with Subsection 6.6.
10.10. Operating Procedures
10.10.a. Particle accelerators, when not in use, shall be secured to prevent unauthorized use.
10.10.b. Only a switch on the accelerator control console shall be routinely used to turn the accelerator beam on and off. The safety interlock system shall not be used to turn off the accelerator beam except in an emergency.
10.10.c. All safety and warning devices, including interlocks, shall be checked for proper operability at intervals not to exceed three (3) months. Results of such test shall be maintained for inspection by the agency at the accelerator facility.
10.10.d. Electrical circuit diagrams of the accelerator, and the associated interlock systems, shall be kept current and maintained for inspection by the agency and available to the operator at each accelerator facility.
10.10.e. If, for any reason, it is necessary to intentionally bypass a safety interlock or interlocks, such action shall be:
10.10.e.1. Authorized by the radiation safety committee and/or the radiation safety officer;
10.10.e.2. Recorded in a permanent log and a notice posted at the accelerator control console; and
10.10.e.3. Terminated as soon as possible.
10.10.f. A copy of the current operating and emergency procedures shall be maintained at the accelerator control panel.
10.11. Radiation Monitoring Requirements
10.11.a. There shall be available at each particle accelerator facility, appropriate portable monitoring equipment which is operable and has been calibrated for the appropriate radiations being produced at the facility. Such equipment shall be tested for proper operation daily and calibrated at intervals not to exceed one year, and after servicing and repair.
10.11.b. A radiation protection survey shall be performed and documented by a qualified expert specifically approved by the agency when changes have been made in shielding, operation, equipment, or occupancy of adjacent areas.
10.11.c. Radiation levels in all high radiation areas shall be continuously monitored. The monitoring devices shall be electrically independent of the accelerator control and interlock systems and capable of providing a remote and local readout with visual and/or audible alarms at both the control panel and at the entrance to high radiation areas, and other appropriate locations so that people entering or present become aware of the existence of the hazard.
10.11.d. All area monitors shall be calibrated quarterly.
10.11.e. Whenever applicable, periodic surveys shall be made to determine the amount of airborne particulate radioactivity present in areas of airborne hazards.
10.11.f. Whenever applicable, periodic smear surveys shall be made to determine the degree of contamination in target and other pertinent areas.
10.11.g. All area surveys shall be made in accordance with the written procedures established by a qualified expert or the radiation safety officer of the particulate accelerator facility.
10.11.h. Records of all radiation protection surveys, calibration results, instrumentation tests, and smear results shall be kept current and on file at each accelerator facility.
10.12. Ventilation Systems
10.12.a. Adequate ventilation shall be provided in areas where airborne radioactivity may be produced.
10.12.b. A registrant, as required by Subsection 6.6., shall not vent, release or otherwise discharge airborne radioactive material to an unrestricted area which exceeds the limits in Section 6., Table 64-23 E, Table II, except as authorized pursuant to Subsection 6.14. or Subdivision 6.6.b. For purposes of this Paragraph, concentrations may be averaged over a period not greater than one year. Every reasonable effort should be made to maintain releases of radioactive material to unrestricted areas as far below these limits as practicable.
W. Va. Code R. § 64-23-11 Registration of Radioactive Materials
11.1. Purpose and Scope
11.1.a. This Section, and Sections 13. and 15. of this rule, provide for the registration of radioactive material. No person shall receive, possess, use, transfer, own, or acquire radioactive material except as authorized pursuant to this Section and Sections 13. and 15. of this rule, or as otherwise provided in these Sections.
11.1.b. In addition to the requirements of this Section, all registrants are subject to the requirements of Sections 1., 6., 13. and 15. of this rule. Furthermore, registrants engaged in industrial radiographic operations are subject to the requirements of Section 8 of this rule, registrants using radionuclides in the healing arts are subject to the requirements of Section 12. of this rule, and registrants engaged in wireline and subsurface tracer studies are subject to the requirements of Section 15. of this rule.
11.2. Source Material
11.2.a. Any person is exempt from this Section to the extent that such person receives, possesses, uses, owns, or transfers source material in any chemical mixture, compound, solution, or alloy in which the source material is by weight less than one-twentieth (1/20) of one (1) percent (five one-hundredths [0.05] percent) of the mixture, compound, solution, or alloy.
11.2.b. Any person is exempt from this Section to the extent that such person receives, possesses, uses, or transfers unrefined and unprocessed ore containing source material; provided that, except as authorized in a specific registration, such person shall not refine or process such ore.
11.2.c. Any person is exempt from this Section to the extent that such person receives, possesses, uses, or transfers:
11.2.c.1. Any quantities of thorium contained in:
11.2.c.1.A. Incandescent gas mantles,
11.2.c.1.B. Vacuum tubes,
11.2.c.1.C. Welding rods,
11.2.c.1.D. Electric lamps for illuminating purposes provided that each lamp does not contain more than fifty (50) milligrams of thorium,
11.2.c.1.E. Germicidal lamps, sunlamps, and lamps for outdoor or industrial lighting provided that each lamp does not contain more than two (2) grams of thorium,
11.2.c.1.F. Rare earth metals and compounds, mixtures, and products containing not more than twenty five one-hundredths [0.25] percent by weight thorium, uranium, or any combination of these, or
11.2.c.1.G. Personnel neutron dosimeters, provided that each dosimeter does not contain more than fifty (50) milligrams of thorium;
11.2.c.2. Source material contained in the following products:
11.2.c.2.A. glazed ceramic Tableware, provided that the glaze contains not more than 20 percent by weight source material,
11.2.c.2.B. Glassware containing not more than ten (10) percent by weight source material, but not including commercially manufactured glass brick, pane glass, ceramic tile, or other glass or ceramic used in construction,
11.2.c.2.C. Glass enamel or glass enamel frit containing not more than ten (10) percent by weight source material imported or ordered for importation into the United States, or initially distributed by manufacturers in the United States, before July 25, 1983, or
11.2.c.2.D. Piezoelectric ceramic containing not more than two (2) percent by weight source material;
11.2.c.3. Photographic film, negatives, and prints containing uranium or thorium;
11.2.c.4. Any finished product or part fabricated of, or containing, tungsten-thorium or magnesium-thorium alloys, provided that the thorium content of the alloy does not exceed four (4) percent by weight and that this exemption shall not be deemed to authorize the chemical, physical, or metallurgical treatment or processing of any such product or part;
11.2.c.5. Uranium contained in counterweights installed in aircraft, rockets, projectiles, and missiles, or stored or handled in connection with installation or removal of such counterweights, provided that:
11.2.c.5.A. The counterweights are manufactured in accordance with a specific registration issued by the U.S. Nuclear Regulatory Commission (NRC), authorizing distribution by the registrant pursuant to 10 CFR Part 40,
11.2.c.5.B. Each counterweight has been impressed with the following legend clearly legible through any plating or other covering: "DEPLETED URANIUM",7
11.2.c.5.C. Each counterweight is durably and legibly labeled or marked with the identification of the manufacturer and the statement: "UNAUTHORIZED ALTERATIONS PROHIBITED",1/ and
11.2.c.5.D. This exemption shall not be deemed to authorize the chemical, physical, or metallurgical treatment or processing of any such counterweights other than repair or restoration of any plating or other covering;
11.2.c.6. Natural or depleted uranium metal used as shielding constituting part of any shipping container, provided that:
11.2.c.6.A. The shipping container is conspicuously and legibly impressed with the legend "CAUTION - RADIOACTIVE SHIELDING - URANIUM", and
11.2.c.6.B. The uranium metal is encased in mild steel or equally fire resistant metal of minimum wall thickness of one-eighth (c) inch (three and two-tenths [3.2] mm);
11.2.c.7. Thorium contained in finished optical lenses, provided that each lens does not contain more than thirty (30) percent by weight of thorium, and that this exemption shall not be deemed to authorize either:
11.2.c.7.A. The shaping, grinding, or polishing of such lens or manufacturing processes other than the assembly of such lens into optical systems and devices without any alteration of the lens, or
11.2.c.7.B. The receipt, possession, use, or transfer of thorium contained in contact lenses, or in spectacles, or in eyepieces in binoculars or other optical instruments;
11.2.c.8. Uranium contained in detector heads for use in fire detection units, provided that each detector head contains not more than five one-thousandths (0.005) microcurie of uranium; or
11.2.c.9. Thorium contained in any finished aircraft engine part containing nickel-thoria alloy, provided that:
11.2.c.9.A. The thorium is dispersed in the nickel-thoria alloy in the form of finely divided thoria (thorium dioxide), and
11.2.c.9.B. The thorium content in the nickel-thoria alloy does not exceed 4 percent by weight.
11.2.d. The exemptions in Subdivision 11.2.b. do not authorize the manufacture of any of the products described.
11.3. Radioactive Material Other Than Source Material
11.3.a. Exempt Concentrations
11.3.a.1. Except as provided in Paragraph 11.3.a.2., any person is exempt from this Section to the extent that such person receives, possesses, uses, transfers, owns or acquires products containing radioactive material introduced in concentrations not in excess of those listed in Table 64-23 Y.
11.3.a.2. No person may introduce radioactive material into a product or material knowing or having reason to believe that it will be transferred to persons exempt under Paragraph 11.3.a.1. or equivalent rules of the NRC, any agreement state or licensing state, except in accordance with a specific registration issued pursuant to Subdivision 11.17.a. or the general registrant provided in Subsection 11.28.
11.3.b. Exempt Quantities
11.3.b.1. Except as provided in Paragraphs 11.3.b.3. and 11.3.b.4., any person is exempt from this rule to the extent that such person receives, possesses, uses, transfers, owns, or acquires radioactive material in individual quantities each of which does not exceed the applicable quantity set forth in Table 64-23 Z.
11.3.b.2. Any person who possesses radioactive material received or acquired under the general registrant formerly provided in Subsection 11.7. is exempt from the requirements for a registrant set forth in this Section to the extent that such person possesses, uses, transfers or owns such radioactive material. Such exemption does not apply for Radium-226.
11.3.b.3. This Subdivision (11.3.b.) does not authorize the production, packaging or repackaging of radioactive material for purposes of commercial distribution, or the incorporation of radioactive material into products intended for commercial distribution.
11.3.b.4. No person may, for purposes of commercial distribution, transfer radioactive material in the individual quantities set forth in Table 64-3 Z, knowing or having reason to believe that such quantities of radioactive material will be transferred to persons exempt under Subdivision 11.3.b. or equivalent rules of the NRC, any agreement state or licensing state, except in accordance with a specific registrant issued by the NRC pursuant to Section 32.18 of 10 CFR Part 32 or by the agency pursuant to Subdivision 11.17.b. which registrant states that the radioactive material may be transferred by the registrant to persons exempt under Subdivision 11.3.b. or the equivalent rules of the NRC, an agreement state, or licensing state.8
11.3.c. Exempt Items
11.3.c.1. Certain Items Containing Radioactive Material. Except for persons who apply radioactive material to, or persons who incorporate radioactive material into the following products, any person is exempt from this rule to the extent that he receives, possesses, uses, transfers, owns, or acquires the following products:8
11.3.c.1.A. Timepieces or hands or dials containing not more than the following specified quantities of radioactive material and not exceeding the following specified radiation dose rate:
11.3.c.1.A.1. Twenty five (25) millicuries (nine hundred twenty five [925] MBq) of tritium per timepiece.
11.3.c.1.A.2. Five (5) millicuries (one hundred eighty five [185] MBq) of tritium per hand.
11.3.c.1.A.3. Fifteen (15) millicuries (fife hundred fifty five [555] MBq) of tritium per dial (bezels when used shall be considered as part of the dial).
11.3.c.1.A.4. One hundred (100) microcuries (three and seven-tenths [3.7] MBq) of promethium-147 per watch or two hundred (200) microcuries (seven and four-tenths [7.4] MBq) of promethium-147 per any other timepiece.
11.3.c.1.A.5. Twenty (20) microcuries (seventy four one-hundredths [0.74] MBq) of promethium-147 per watch hand or forty (40) microcuries (one and forty eight one-hundredths [1.48] MBq) of Promethium-147 per other timepiece hand.
11.3.c.1.A.6. Sixty (60) microcuries (two and twenty two one-hundredths [2.22] MBq) of promethium-147 per watch dial or one hundred twenty (120) microcuries (four and forty four one-hundredths [4.44] MBq) of Promethium-147 per other timepiece dial (bezels when used shall be considered as part of the dial).
11.3.c.1.A.7. The radiation dose rate from hands and dials containing promethium-147 will not exceed, when measured through fifty (50) milligrams per square centimeter of absorber: 11.3.c.1.A.7.(a) For wrist watches, one-tenth (0.1) millirad (one [1] Gy) per hour at ten (10) centimeters from any surface. 11.3.c.1.A.7.(b) For pocket watches, one-tenth (0.1) millirad (one [1] Gy) per hour at one (1) centimeter from any surface. 11.3.c.1.A.7.(c) For any other timepiece, 0.2 millirad (2 Gy) per hour at 10 centimeters from any surface.
11.3.c.1.A.8. One microcurie (37 kBq) of Radium-226 per timepiece in timepieces acquired prior to July 1, 2001..
11.3.c.1.A.9. Lock illuminators containing not more than fifteen (15) millicuries (five hundred fifty five [555] MBq) of tritium or not more than two (2) millicuries (seventy [74] MBq) of Promethium-147 installed in automobile locks. The radiation dose rate from each lock illuminator containing Promethium-147 will not exceed one (1) millirad (ten [10] Gy) per hour at one (1) centimeter from any surface when measured through fifty (50) milligrams per square centimeter of absorber.
11.3.c.1.B. Precision balances containing not more than one (1) millicurie (thirty seven (thirty seven [37] MBq) of tritium per balance or not more than five-tenths (0.5) millicurie (eighteen and five-tenths [18.5] MBq) of tritium per balance part.
11.3.c.1.C. Automobile shift quadrants containing not more than twenty five 25 millicuries (nine hundred twenty five [925] MBq) of tritium.
11.3.c.1.D. Marine compasses containing not more than seven hundred fifty (750) millicuries (twenty seven and eight-tenths [27.8] GBq) of tritium gas and other marine navigational instruments containing not more than two hundred fifty (250) millicuries (nine and twenty five one-hundredths [9.25] GBq) of tritium gas.
11.3.c.1.E. Thermostat dials and pointers containing not more than twenty five (25) millicuries (nine hundred twenty five [925] MBq) of tritium per thermostat.
11.3.c.1.F. Electron tubes; provided, that each tube does not contain more than one of the following specified quantities of radioactive material:
11.3.c.1.F.1. One hundred fifty (150) millicuries (five and fifty five one-hundredths [5.55] GBq) of tritium per microwave receiver protector tube or ten (10) millicuries (three hundred seventy [370] mBq) of tritium per any other electron tube.
11.3.c.1.F.2. One (1) microcurie (thirty seven [37] kBq) of Cobalt-60.
11.3.c.1.F.3. Five (5) microcuries (one hundred eighty five [185] kBq) of nickel-63.
11.3.c.1.F.4. Thirty (30) microcuries (one and eleven one-hundredths [1.11] MBq) of krypton-85.
11.3.c.1.F.5. Five (5) microcuries (one hundred eighty five [185] kBq) of cesium-137.
11.3.c.1.F.6. Thirty (30) microcuries (one and eleven one-hundredths [1.11] MBq) of promethium-147.
11.3.c.1.G. And provided further, that the radiation dose rate from each electron tube containing radioactive material will not exceed one (1) millirad (ten [10] Gy) per hour at one (1) centimeter from any surface when measured through seven (7) milligrams per square centimeter of absorber.
11.3.c.1.H. Ionizing radiation measuring instruments containing, for purposes of internal calibration or standardization, one or more sources of radioactive material, provided that:
11.3.c.1.H.1. Each source contains no more than one exempt quantity set forth in Table 64-23 Z, and
11.3.c.1.H.2. Each instrument contains no more than ten (10) exempt quantities. For purposes of this requirement, an instrument's sources may contain either one or different types of radionuclides and an individual exempt quantity may be composed of fractional parts of one or more of the exempt quantities in Table 64-23 Z, provided that the sum of such fractions shall not exceed unity.
11.3.c.1.H.3. For Americium-241, five one-hundredths (0.05) microcurie (one and eighty five one-hundredths [1.85] kBq) is considered an exempt quantity under Subdivision C.4c.i.(8).
11.3.c.1.I. Spark gap irradiators containing not more than 1 microcurie (37 kBq) of Cobalt-60 per spark gap irradiator for use in electrically ignited fuel oil burners having a firing rate of at least three (3) gallons (eleven and four-tenths [11.4] l) per hour.
11.3.c.2. Self-Luminous Products Containing Radioactive Material
11.3.c.2.A. Tritium, Krypton-85, or Promethium-147. Except for persons who manufacture, process, or produce self-luminous products containing tritium, Krypton-85, or Promethium-147, any person is exempt from this rule to the extent that such person receives, possesses, uses, transfers, owns, or acquires tritium, Krypton-85 or Promethium-147 in self-luminous products manufactured, processed, produced, imported, or transferred in accordance with a specific registrant issued by the NRC pursuant to Section 32.22 of 10 CFR Part 32, which registrant authorizes the transfer of the product to persons who are exempt from regulatory requirements. The exemption in Paragraph 11.3.c.2. does not apply to tritium, Krypton-85, or Promethium-147 used in products primarily for frivolous purposes or in toys or adornments.
11.3.c.2.B. Radium-226. Any person is exempt from this rule to the extent that such person receives, possesses, uses, transfers, or owns articles containing less than one-tenth (0.1) microcurie (3.7 kBq) of Radium-226 which were acquired prior to July 1, 2001.
11.3.c.3. Gas and Aerosol Detectors Containing Radioactive Material
11.3.c.3.A. Except for persons who manufacture, process, or produce gas and aerosol detectors containing radioactive material, any person is exempt from this rule to the extent that such person receives, possesses, uses, transfers, owns, or acquires radioactive material in gas and aerosol detectors designed to protect life or property from fires and airborne hazards provided that detectors containing radioactive material shall have been manufactured, imported, or transferred in accordance with a specific registrant issued by the NRC9equipment, device, commodity, or other product containing byproduct material whose subsequent possession, use, transfer, and disposal by all other persons are exempted from regulatory requirements may be obtained only from the NRC, Washington, D.C. 20555 pursuant to Section 32.26 of 10 CFR Part 32; or a licensing state pursuant to Subdivision 11.3.a.3.A., which authorizes the transfer of the detectors to persons who are exempt from regulatory requirements.
11.3.c.3.B. Gas and aerosol detectors previously manufactured and distributed to general registrants in accordance with a specific registrant issued by an agreement state shall be considered exempt under Subparagraph 11.3.c.3.A., provided that the device is labeled in accordance with the specific registrant authorizing distribution of the generally registered device, and provided further that they meet the requirements of Subdivision 11.17.c.
11.3.c.3.C. Gas and aerosol detectors containing NARM previously manufactured and distributed in accordance with a specific registrant issued by a licensing state shall be considered exempt under Subparagraph 11.3.c.3.A., provided that the device is labeled in accordance with the specific registrant authorizing distribution, and provided further that they meet the requirements of Subdivision 11.17.c.
11.3.c.4. Resins Containing Scandium-46 and Designed for Sand Consolidation in Oil Wells. Any person is exempt from this rule to the extent that such person receives, possesses, uses, transfers, owns or acquires synthetic plastic resins containing scandium-46 which are designed for sand consolidation in oil wells. Such resins shall have been manufactured or imported in accordance with a specific registrant issued by the NRC, or shall have been manufactured in accordance with the specifications contained in a specific registrant issued by the agency or any agreement state to the manufacturer of such resins pursuant to registration requirements equivalent to those in Sections 32.16 and 32.17 of 10 CFR Part 32 of the rules of the NRC. This exemption does not authorize the manufacture of any resins containing scandium-46.
11.4. Types of Registrants. Registrants for radioactive materials are of two types: general and specific.
11.4.a. General registrants provided in this Section are effective without the filing of applications with the agency or the issuance of registration documents to the particular persons, although the filing of a certificate with the agency may be required by the particular general registrant. The general registrant is subject to all other applicable portions of this rule and any limitations of the general registrant.
11.4.b. Specific registrants require the submission of an application to the agency and the issuance of a registration document by the agency. The registrant is subject to all applicable portions of this rule as well as any limitations specified in the registration document.
11.5. General Registrants - Source Material
11.5.a. A general registrant is hereby issued authorizing commercial and industrial firms, research, educational and medical institutions, and state and local government agencies to use and transfer not more than fifteen (15) pounds (six and eighty two one-hundredths [6.82] kg) of source material at any one time for research, development, educational, commercial, or operational purposes. A person authorized to use or transfer source material, pursuant to this general registrant, may not receive more than a total of one hundred fifty (150) pounds (sixty eight and two-tenths [68.2] kg) of source material in any one (1) calendar year.
11.5.b. Persons who receive, possess, use, or transfer source material pursuant to the general registrant issued in Subdivision 11.15.a. are exempt from the provisions of Sections 6. and 14. of this rule to the extent that such receipt, possession, use, or transfer is within the terms of such general registrant; provided, however, that this exemption shall not be deemed to apply to any such person who is also in possession of source material under a specific registrant issued pursuant to this Section.
11.5.c. Persons who receive, possess, use, or transfer source material pursuant to the general registrant in Subdivision 11.5.a. are prohibited from administering source material, or the radiation therefrom, either externally or internally, to human beings except as may be authorized by the agency in a specific registrant.
11.5.d. A general registrant is hereby issued authorizing the receipt of title to source material without regard to quantity. This general registrant does not authorize any person to receive, possess, use, or transfer source material.
11.6. Depleted Uranium in Industrial Products and Devices
11.6.a. A general registrant is hereby issued to receive, acquire, possess, use, or transfer, in accordance with the provisions of Subdivisions 11.6.b., c., d., and e., depleted uranium contained in industrial products or devices for the purpose of providing a concentrated mass in a small volume of the product or device.
11.6.b. The general registrant in Subdivision 11.6.a. applies only to industrial products or devices which have been manufactured either in accordance with a specific registrant issued to the manufacturer of the products or devices pursuant to Subdivision 11.17.1. or in accordance with a specific registration issued to the manufacturer by the NRC or an agreement state which authorizes manufacture of the products or devices for distribution to persons generally licensed by the NRC or an agreement state.
11.6.c. Persons who receive, acquire, possess, or use depleted uranium pursuant to the general registrant established by Subdivision 11.6.a. shall file Agency Form W "certificate - use of depleted uranium under general registrant", with the agency. The form shall be submitted within thirty (30) days after the first receipt or acquisition of such depleted uranium. The general registrant shall furnish on Agency Form W the following information and such other information as may be required by that form:
11.6.c.1. Name and address of the general registrant;
11.6.c.2. A statement that the general registrant has developed and will maintain procedures designed to establish physical control over the depleted uranium described in Subdivision 11.6.a. and designed to prevent transfer of such depleted uranium in any form, including metal scrap, to persons not authorized to receive the depleted uranium; and
11.6.c.2.A. Name and title, address, and telephone number of the individual duly authorized to act for and on behalf of the general registrant in supervising the procedures identified in Paragraph 11.6.c.2.
11.6.c.2.B. The general registrant possessing or using depleted uranium under the general registration established by Subdivision 11.6.a. shall report in writing to the agency any changes in information furnished by him in Agency Form W "Certificate - Use of Depleted Uranium Under General Registration". The report shall be submitted within thirty (30) days after the effective date of such change.
11.6.d. A person who receives, acquires, possesses, or uses depleted uranium pursuant to the general registration established by Subdivision 11.6.a.:
11.6.d.1. Shall not introduce such depleted uranium, in any form, into a chemical, physical, or metallurgical treatment or process, except a treatment or process for repair or restoration of any plating or other covering of the depleted uranium;
11.6.d.2. Shall not abandon such depleted uranium;
11.6.d.3. Shall transfer or dispose of such depleted uranium only by transfer in accordance with the provisions of Subsection 11.26. In the case where the transferee receives the depleted uranium pursuant to the general registration established by Subdivision 11.6.a., the transferor shall furnish the transferee a copy of this rule and a copy of Agency Form W. In the case where the transferee receives the depleted uranium pursuant to a general registration contained in the NRC's or agreement state's rule equivalent to Subdivision 11.6.a., the transferor shall furnish the transferee a copy of this rule and a copy of Agency Form W accompanied by a note explaining that use of the product or device is regulated by the NRC or agreement state under requirements substantially the same as those in this rule;
11.6.d.4. Within thirty (30) days of any transfer, shall report in writing to the agency the name and address of the person receiving the depleted uranium pursuant to such transfer; and
11.6.d.5. Shall not export such depleted uranium except in accordance with a license issued by the NRC pursuant to 10 CFR Part 110.
11.6.e. Any person receiving, acquiring, possessing, using, or transferring depleted uranium pursuant to the general registration established by Subdivision 11.6.a. is exempt from the requirements of Sections 6. and 14. of this rule with respect to the depleted uranium covered by that general registration.
11.7. General Registrations - Radioactive Material Other Than Source Material
11.7.a. Certain Devices and Equipment. A general registration is hereby issued to transfer, receive, acquire, own, possess, and use radioactive material incorporated in the following devices or equipment which have been manufactured, tested and labeled by the manufacturer in accordance with a specific registration issued to the manufacturer by the NRC for use pursuant to Section 31.3 of 10 CFR Part 31. This general registration is subject to the provisions of Subsections 4.3 through 4.7, Paragraph 11.3.a.2., Subsections 11.19., 11.26., 11.27. and Sections 6., 14. and 15. of this rule.
11.7.a.1. Static Elimination Device. Devices designed for use as static eliminators which contain, as a sealed source or sources, radioactive material consisting of a total of not more than five hundred (500) microcuries (eighteen and five-tenths [18.5] MBq) of Polonium-210 per device.
11.7.a.2. Ion Generating Tube. Devices designed for ionization of air which contain, as a sealed source or sources, radioactive material consisting of a total of not more than five hundred (500) microcuries (eighteen and five-tenths [18.5] MBq) of Polonium-210 per device or a total of not more than fifty (50) millicuries (one and eighty five one-hundredths [1.85] GBq) of hydrogen-3 (tritium) per device.
11.7.b. Certain Measuring, Gauging or Controlling Devices
11.7.b.1. A general registration is hereby issued to commercial and industrial firms and to research, educational and medical institutions, individuals in the conduct of their business, and state or local government agencies to own, receive, acquire, possess, use or transfer in accordance with the provisions of Paragraph 11.7.b.2., 3. and 4., radioactive material, excluding special nuclear material, contained in devices designed and manufactured for the purpose of detecting, measuring, gauging or controlling thickness, density, level, interface location, radiation, leakage, or qualitative or quantitative chemical composition, or for producing light or an ionized atmosphere.
11.7.b.2. The general registration in Paragraph 11.7.b.1. applies only to radioactive material contained in devices which have been manufactured and labeled in accordance with the specifications contained in a specific registration issued by the agency pursuant to Subdivision 11.17.d. or in accordance with the specifications contained in a specific registration issued by the NRC, an agreement state or a licensing state, which authorizes distribution of devices to persons generally licensed by the NRC, an agreement state or a licensing state.
11.7.b.3. Any person who owns, receives, acquires, possesses, uses, or transfers radioactive material in a device pursuant to the general registration in Paragraph 11.7.a.1. or 11.7.b.3.A. shall assure that all labels affixed to the device at the time of receipt, and bearing a statement that removal of the label is prohibited, are maintained thereon and shall comply with all instructions and precautions provided by such labels;
11.7.b.3.A. Shall assure that the device is tested for leakage of radioactive material and proper operation of the "on-off" mechanism and indicator, if any, at no longer than six (6) month intervals or at such other intervals as are specified in the label, however,
11.7.b.3.A.1. Devices containing only krypton need not be tested for leakage of radioactive material, and
11.7.b.3.A.2. Devices containing only tritium or not more than one hundred (100) microcuries (three and seven-tenths [3.7] MBq) of other beta or beta-gamma-emitting material or ten (10) microcuries (thirty seven one-hundredths [0.37] MBq) of alpha-emitting material and devices held in storage in the original shipping container prior to initial installation need not be tested for any purpose;
11.7.b.3.B. Shall assure that other testing, installation, servicing, and removal from installation involving the radioactive material, its shielding or containment, are performed:
11.7.b.3.B.1. In accordance with the instructions provided by the labels, or
11.7.b.3.B.2. By a person holding an applicable specific registration from the agency, the NRC, an agreement state or a licensing state to perform such activities;
11.7.b.3.C. Shall maintain records showing compliance with the requirements of Subparagraph 11.7.b.3.A. and B. The records shall show the results of tests. The records also shall show the dates of performance of, and the names of persons performing, testing, installation, servicing, and removal from installation concerning the radioactive material, its shielding or containment. Records of tests for leakage of radioactive material required by Subparagraph 11.7.b.3.A. shall be maintained for one (1) year after the next required leak test is performed or until the sealed source is transferred or disposed of. Records of tests of the "on-off" mechanism and indicator required by Subparagraph 11.7.b.3.A. shall be maintained for one (1) year after the next required test of the "on-off" mechanism and indicator is performed or until the sealed source is transferred or disposed of. Records which are required by Subparagraph 11.7.b.3.A. shall be maintained for a period of two (2) years from the date of the recorded event or until the device is transferred or disposed of;
11.7.b.3.D. Upon the occurrence of a failure of or damage to, or any indication of a possible failure of or damage to, the shielding of the radioactive material or the "on-off" mechanism or indicator, or upon the detection of five one-thousandths (0.005) microcurie (one hundred eighty five [185] Bq) or more removable radioactive material, shall immediately suspend operation of the device until it has been repaired by the manufacturer or other person holding an applicable specific registration from the agency, the NRC, an agreement state or a licensing state to repair such devices, or disposed of by transfer to a person authorized by an applicable specific registration to receive the radioactive material contained in the device and, within thirty (30) days, furnish to the agency a report containing a brief description of the event and the remedial action taken;
11.7.b.3.E. Shall not abandon the device containing radioactive material;
11.7.b.3.F. Except as provided in Subparagraph 11.7.b.3.G., shall transfer or dispose of the device containing radioactive material only by transfer to a specific registrant of the agency, the NRC, an agreement state or a licensing state whose specific registration authorizes him to receive the device and within thirty (30) days after transfer of a device to a specific registrant shall furnish to the agency a report containing identification of the device by manufacturer's name and model number and the name and address of the person receiving the device. No report is required if the device is transferred to the specific registrant in order to obtain a replacement device;
11.7.b.3.G. Shall transfer the device to another general registrant only:
11.7.b.3.G.1. Where the device remains in use at a particular location. In such case the transferor shall give the transferee a copy of this rule and any safety documents identified in the label on the device and within thirty (30) days of the transfer, report to the agency the manufacturer's name and model number of device transferred, the name and address of the transferee, and the name and position of an individual who may constitute a point of contact between the agency and the transferee; or
11.7.b.3.G.2. Where the device is held in storage in the original shipping container at its intended location of use prior to initial use by a general registration; and
11.7.b.3.H. Shall comply with the provisions of Sections 6.53. and 6.54. of this rule for reporting radiation incidents, theft, or loss of registered material, but shall be exempt from the other requirements of Sections 6. and 14. of this rule.
11.7.b.4. The general registration in Paragraph 11.7.b.1. does not authorize the manufacture of devices containing radioactive material.
11.7.b.5. The general registration provided in Paragraph 11.7.b.1. is subject to the provisions of Subsections 4.2 through 4.7., 11.19.,11.26.,11.27. and Section 15. of this rule.
11.8. Luminous Safety Devices for Aircraft
11.8.a. A general registration is hereby issued to own, receive, acquire, possess, and use tritium or Promethium-147 contained in luminous safety devices for use in aircraft, provided:
11.8.a.1. Each device contains not more than ten (10) curies (three hundred seventy [370] GBq) of tritium or three hundred 300 millicuries (eleven one-tenths [11.1] GBq) of promethium-147; and
11.8.a.2. Each device has been manufactured, assembled or imported in accordance with a specific license issued by the NRC, or each device has been manufactured or assembled in accordance with the specifications contained in a specific registration issued by the agency or any agreement state to the manufacturer or assembler of such device pursuant to registration requirements equivalent to those in Section 32.53 of 10 CFR Part 32.
11.8.b. Persons who own, receive, acquire, possess, or use luminous safety devices pursuant to the general registration in Subdivision 11.8.a. are exempt from the requirements of Sections 6. and 14. of this rule except that they shall comply with the provisions of Sections 6.53. and 6.54.
11.8.c. This general registration does not authorize the manufacture, assembly, or repair of luminous safety devices containing tritium or Promethium-147.
11.8.d. This general registration does not authorize the ownership, receipt, acquisition, possession or use of Promethium-147 contained in instrument dials.
11.8.e. This general registration is subject to the provisions of Subsections 4.3. through 4.7.,11.19., 11.26., 11.27., and Section 15. of this rule.
11.9. Ownership of Radioactive Material. A general registration is hereby issued to own radioactive material without regard to quantity. Notwithstanding any other provisions of this Section, this general registration does not authorize the manufacture, production, transfer, receipt, possession or use of radioactive material.
11.10. Calibration and Reference Sources
11.10.a. A general registration is hereby issued to those persons listed below to own, receive, acquire, possess, use, and transfer, in accordance with the provisions of Subdivisions 11.10.d. and e. and Americium-241 in the form of calibration or reference sources:
11.10.a.1. Any person who holds a specific registration issued by the agency which authorizes him to receive, possess, use, and transfer radioactive material; and
11.10.a.2. Any person who holds a specific registration issued by the NRC which authorizes him to receive, possess, use, and transfer special nuclear material.
11.10.b. A general registration is hereby issued to own, receive, possess, use, and transfer plutonium in the form of calibration or reference sources in accordance with the provisions of Subdivisions 11.10.d and 11.10.e. to any person who holds a specific registration issued by the agency which authorizes him to receive, possess, use, and transfer radioactive material.
11.10.c. A general registration is hereby issued to own, receive, possess, use, and transfer Radium-226 in the form of calibration or reference sources in accordance with the provisions of Subdivisions 11.10.d. and 11.10.e. to any person who holds a specific registration issued by the agency which authorizes him to receive, possess, use, and transfer radioactive material.
11.10.d. The general registrations in Subdivisions 11.10.a., 11.10.b. and 11.10.c. apply only to calibration or reference sources which have been manufactured in accordance with the specifications contained in a specific registration issued to the manufacturer or importer of the sources by the NRC pursuant to Section 32.57 of 10 CFR Part 32 or Section 70.39 of 10 CFR Part 70 or which have been manufactured in accordance with the specifications contained in a specific registration issued to the manufacturer by the agency, any agreement state or licensing state pursuant to registration requirements equivalent to those contained in Section 32.57 of 10 CFR Part 32 or Section 70.39 of 10 CFR Part 70.
11.10.e. The general registrations provided in Subdivisions 11.10.a., 11.10.b. and 11.10.c. are subject to the provisions of Subsections 4.3 through 4.7., 11.19., 11.26., 11.27., and Sections 6., 14., and 15. of this rule. In addition, persons who own, receive, acquire, possess, use, or transfer one or more calibration or reference sources pursuant to these general registrations:
11.10.e.1. Shall not possess at any one time, at any one location of storage or use, more than five (5) microcuries (one hundred eighty five [185] kBq) of Americium-241, five (5) microcuries (one hundred eighty five [185] kBq) of plutonium, five (5) microcuries (one hundred eighty five [185] kBq) of Radium-226 in such sources;
11.10.e.2. Shall not receive, possess, use, or transfer such source unless the source, or the storage container, bears a label which includes one of the following statements, as appropriate, or a substantially similar statement which contains the information called for in one of the following statements, as appropriate:
11.10.e.2.A. The receipt, possession, use and transfer of this source, Model ________, Serial No._____________, are subject to a general registration and the rules of the NRC or of a state with which the NRC has entered into an agreement for the exercise of regulatory authority. Do not remove this label.
CAUTION - RADIOACTIVE MATERIAL
THIS SOURCE CONTAINS (AMERICIUM-241).
(PLUTONIUM) DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE. _____________________________
Name of manufacturer or importer
11.10.e.2.B. The receipt, possession, use and transfer of this source, Mode ________, Serial No. ____________ , are subject to a general registration and the rules of a Licensing State. Do not remove this label.
CAUTION - RADIOACTIVE MATERIAL
THIS SOURCE CONTAINS RADIUM-226.
DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE. _____________________________
Name of manufacturer or importer
11.10.e.3. Shall not transfer, abandon, or dispose of such source except by transfer to a person authorized by a registration from the agency, the NRC, an agreement state or a licensing state to receive the source;
11.10.e.4. Shall store such source, except when the source is being used, in a closed container adequately designed and constructed to contain Americium-241, Plutonium, or Radium-226 which might otherwise escape during storage; and
11.10.e.5. Shall not use such source for any purpose other than the calibration of radiation detectors or the standardization of other sources.
11.10.f. These general registrations do not authorize the manufacture of calibration or reference sources containing Americium-241, Plutonium, or Radium-226.
11.11. General Registration for Use of Radioactive Material for Certain In Vitro Clinical or Laboratory Testing.
11.11.a. A general registration is hereby issued to any physician, veterinarian, clinical laboratory or hospital to receive, acquire, possess, transfer or use, for any of the following stated tests, in accordance with the provisions of Subdivisions 11.11.b., 11.11.c., 11.11.d., 11.11.e., and 11.11.f., the following radioactive materials in prepackaged units for use in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to human beings or animals:
11.11.a.1. Carbon-14, in units not exceeding ten (10) microcuries (three hundred seventy [370] kBq) each.
11.11.a.2. Cobalt-57, in units not exceeding ten (10) microcuries (three hundred seventy [370] kBq) each.
11.11.a.3. Hydrogen-3 (tritium), in units not exceeding fifty (50) microcuries (one and eighty five one-hundredths [1.85] MBq) each.
11.11.a.4. Iodine-125, in units not exceeding ten (10) microcuries (three hundred seventy [370] kBq) each.
11.11.a.5. Mock Iodine-125 reference or calibration sources, in units not exceeding five one-hundredths (0.05) microcurie (one and eighty five one-hundredths 1.85 kBq) of iodine-129 and five one-thousandths (0.005) microcurie (one and eighty five one-hundredths [1.85] Bq) of Americium-241 each.
11.11.a.6. Iodine-131, in units not exceeding ten (10) microcuries (three hundred seventy [370] kBq) each.
11.11.a.7. Iron-59, in units not exceeding twenty (20) microcuries (seven hundred forty [740] kBq) each.
11.11.a.8. Selenium-75, in units not exceeding ten (10) microcuries (three hundred seventy [370] kBq) each.
11.11.b. No person shall receive, acquire, possess, use or transfer radioactive material pursuant to the general registration established by Subdivision 11.11.a. until he has filed Agency Form F, "certificate - in vitro testing with radioactive material under general registration", with the agency and received from the agency a validated copy of Agency Form V with certification number assigned. The physician, veterinarian, clinical laboratory or hospital shall furnish on agency form v the following information and such other information as may be required by that form:
11.11.b.1. Name and address of the physician, veterinarian, clinical laboratory or hospital;
11.11.b.2. The location of use; and
11.11.b.3. A statement that the physician, veterinarian, clinical laboratory or hospital has appropriate radiation measuring instruments to carry out in vitro clinical or laboratory tests with radioactive material as authorized under the general registration in Subdivision 11.11.a. and that such tests will be performed only by personnel competent in the use of such instruments and in the handling of the radioactive material.
11.11.c. A person who receives, acquires, possesses or uses radioactive material pursuant to the general registration established by Subdivision 11.11.a. shall comply with the following:
11.11.c.1. The general registrant shall not possess at any one time, pursuant to the general registration in Subdivision 11.11.a., at any one location of storage or use, a total amount of Iodine-125, Iodine-131, Selenium-75, Iron-59, or Cobalt-57 in excess of two hundred (200) microcuries (seven and four-tenths [7.4] MBq).
11.11.c.2. The general registrant shall store the radioactive material, until used, in the original shipping container or in a container providing equivalent radiation protection.
11.11.c.3. The general registrant shall use the radioactive material only for the uses authorized by Subdivision 11.11.a.
11.11.c.4. The general registrant shall not transfer the radioactive material to a person who is not authorized to receive it pursuant to a registration issued by the agency, the NRC, any agreement state or licensing state, nor transfer the radioactive material in any manner other than in the unopened, labeled shipping container as received from the supplier.
11.11.c.5. The general registrant shall dispose of the mock Iodine-125 reference or calibration sources described in Paragraph 11.11.a.7. as required by Subsection 6.13. of this rule.
11.11.d. The general registrant shall not receive, acquire, possess, or use radioactive material pursuant to Subdivision 11.11.a.:
11.11.d.1. Except as prepackaged units which are labeled in accordance with the provisions of an applicable specific registration issued pursuant to Subdivision 11.17.g. or in accordance with the provisions of a specific registration issued by the NRC, any agreement state or licensing state which authorizes the manufacture and distribution of Iodine-125, Iodine-131, Carbon-14, Hydrogen-3 (tritium), Iron-59, Selenium-75, Cobalt-57, or mock Iodine-125 to persons generally registered under Subparagraph 11.3.3.c.A. or its equivalent, and
11.11.d.2. Unless one of the following statements, as appropriate, or a substantially similar statement which contains the information called for in one of the following statements, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure which accompanies the package:
11.11.d.2.A. This radioactive material shall be received, acquired, possessed, and used only by physicians, veterinarians, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the rules and a general registration of the NRC or of a state with which the commission has entered into an agreement for the exercise of regulatory authority. ____________________ Name of manufacturer
11.11.d.2.B. This radioactive material shall be received, acquired, possessed, and used only by physicians, veterinarians, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use and transfer are subject to the rules and a general registration of a licensing state. ____________________ Name of manufacturer
11.11.e. The physician, veterinarian, clinical laboratory or hospital possessing or using radioactive material under the general registration of Subdivision 11.11.a. shall report in writing to the agency, any changes in the information furnished by him in the "Certificate - In Vitro Testing With Radioactive Material Under General Registration", Agency Form V. The report shall be furnished within thirty (30) days after the effective date of such change.
11.11.f. Any person using radioactive material pursuant to the general registration of Subdivision 11.11.a. is exempt from the requirements of Sections 6. and 14. of this rule with respect to radioactive material covered by that general registration, except that such persons using the mock Iodine-125 described in Paragraph 11.11.a.7. shall comply with the provisions of Subsections 6.13., 6.53. and 6.54. of this rule.
11.12. Ice Detection Devices
11.12.a. A general registration is hereby issued to own, receive, acquire, possess, use, and transfer strontium-90 contained in ice detection devices, provided each device contains not more than fifty (50) microcuries (one and eighty five one-hundredths [1.85] MBq) of strontium-90 and each device has been manufactured or imported in accordance with a specific registration issued by the NRC or each device has been manufactured in accordance with the specifications contained in a specific registration issued by the agency or an agreement state to the manufacturer of such device pursuant to registration requirements equivalent to those in Section 32.61 of 10 CFR Part 32.
11.12.b. Persons who own, receive, acquire, possess, use, or transfer Strontium-90 contained in ice detection devices pursuant to the general registration in Subdivision 11.12.a.,
11.12.b.1. Shall, upon occurrence of visually observable damage, such as a bend or crack or discoloration from overheating to the device, discontinue use of the device until it has been inspected, tested for leakage and repaired by a person holding a specific registration from the NRC or an agreement state to manufacture or service such devices; or shall dispose of the device pursuant to the provisions of Subsection 6.13. of this rule;
11.12.b.2. Shall assure that all labels affixed to the device at the time of receipt, and which bear a statement which prohibits removal of the labels, are maintained thereon; and
11.12.b.3. Are exempt from the requirements of Sections 6. and 14. of this rule except that such persons shall comply with the provisions of Subsections 6.13., 6.53. and 6.54.
11.12.c. This general registration does not authorize the manufacture, assembly, disassembly or repair of strontium-90 in ice detection devices.
11.12.d. This general registration is subject to the provisions of Subsections 4.3 through 4.7., 11.19., 11.26., 11.27. and Section 15. of this rule.
11.13. Filing Application for Specific Registrations
11.13.a. Applications for specific registrations shall be filed on a form prescribed by the agency.
11.13.b. The agency may at any time after the filing of the original application, and before the expiration of the registration, require further statements in order to enable the agency to determine whether the application should be granted or denied or whether a registration should be modified or revoked.
11.13.c. Each application shall be signed by the applicant or registrant or a person duly authorized to act for and on his behalf.
11.13.d. An application for a registration may include a request for a registration authorizing one or more activities.
11.13.e. In his application, the applicant may incorporate by reference information contained in previous applications, statements, or reports filed with the agency provided such references are clear and specific.
11.13.f. Applications and documents submitted to the agency may be made available for public inspection except that the agency may withhold any document or part thereof from public inspection if disclosure of its content is not required in the public interest and would adversely affect the interest of a person concerned.
11.14. General Requirements for the Issuance of Specific Registrations. A registration application will be approved if the agency determines that:
11.14.a. The applicant is qualified by reason of training and experience to use the material in question for the purpose requested in accordance with this rule in such a manner as to minimize danger to public health and safety or property;
11.14.b. The applicant's proposed equipment, facilities, and procedures are adequate to minimize danger to public health and safety or property;
11.14.c. The issuance of the registration will not be inimical to the health and safety of the public; and
11.14.d. The applicant satisfies any applicable special requirements in Subsections 11.15., 11.17., Sections 8.,13. or 15. of this rule.
11.14.e. Environmental Report, Commencement of Construction. In the case of an application for a registration to receive and possess radioactive material for commercial waste disposal by land burial, or for the conduct of any other activity which the agency determines will significantly affect the quality of the environment, the agency, before commencement of construction of the plant or facility in which the activity will be conducted, has concluded, after weighing the environmental, economic, technical and other benefits against environmental costs and considering available alternatives, that the action called for is the issuance of the proposed registration, with any appropriate conditions to protect environmental values. Commencement of construction prior to such conclusion shall be grounds for denial of a registration to receive and possess radioactive material in such plant or facility. As used in this Paragraph the term "commencement of construction" is any clearing of land, excavation, or other substantial action that would adversely affect the environment of a site. The term does not mean site exploration, necessary roads for site exploration, borings to determine foundation conditions, or other preconstruction monitoring or testing to establish background information related to the suitability of the site or the protection of environmental values.
11.14.f. Financial Surety Arrangements for Site Reclamation
11.14.f.1. Financial surety arrangements for site reclamation which may consist of surety bonds, cash deposits, certificates of deposit, deposits of government securities, letters or lines of credit, or any combination of the above for the categories of registrations listed in Paragraph 11.14.f.4. shall be established to ensure the protection of the public health and safety in the event of abandonment, default, or other inability of the registrant to meet the requirements of the act and this rule.
11.14.f.1.A. The amount of funds to be ensured by such surety arrangements shall be based on agency-approved cost estimates.
11.14.f.1.B. Self insurance, or any arrangement which essentially constitutes self insurance, will not satisfy the surety requirement since this provides no additional assurance other than that which already exists through registration requirements.
11.14.f.2. The arrangements required in Subdivision 11.14.f.1. shall be established prior to issuance of the registration to assure that sufficient funds will be available to carry out the decontamination and decommissioning of the facility.
11.14.f.3. Amendments to registrations in effect on July 1, 2001. may be issued providing that the required surety arrangements are established within ninety (90) days .
11.14.f.4. The following specific registrations are required to make financial surety arrangements:
11.14.f.4.A. Major processors;
11.14.f.4.B. Waste handling registrants;
11.14.f.4.C. Former U.S. Atomic Energy Commission or NRC licensed facilities; and
11.14.f.4.D. All others except persons exempt pursuant to Paragraph 11.14.f.5.
11.14.f.5. The following persons are exempt from the requirements of 11.14.f.1.:
11.14.f.5.A. All state, local, or other government agencies, unless they are subject to Subparagraph 11.14.f.4.B.;
11.14.f.5.B. Persons authorized to possess no more than one thousand (1,000) times the quantity specified in Table 64-23 Z or combination of radioactive material listed therein as given in Table 64-23 Z, note 1;
11.14.f.5.C. Persons authorized to possess Hydrogen-3 contained as hydrogen gas in a sealed source; or
11.14.f.5.D. Persons authorized to possess radioactive noble gases in sealed sources with no radioactive daughter product with half-life greater than thirty (30) days.
11.15. Special Requirements for Issuance of Certain Specific Registrations for Radioactive Material
11.15.a. Use of Sealed Sources in Industrial Radiography. In addition to the requirements set forth in Subsection 11.14., a specific registration for use of sealed sources in industrial radiography will be issued if:
11.15.a.1. The applicant will have an adequate program for training radiographic personnel and submits to the agency a schedule or description of such program which specifies the:
11.15.a.1.A. Initial training,
11.15.a.1.B. Periodic training,
11.15.a.1.C. On-the-job training, and
11.15.a.1.D. Means to be used by the registrant to determine the radiographic personnel's knowledge and understanding of and ability to comply with agency rules and registration requirements, and the operating and emergency procedures of the applicant.
11.15.b. The applicant has established and submits to the agency satisfactory written operating and emergency procedures described in Subsection 8.15. of this rule;
11.15.c. The applicant will have an internal inspection system adequate to assure that this rule, registration provisions, and the applicant's operating and emergency procedures are followed by radiographic personnel; the inspection system shall include the performance of internal inspections at intervals not to exceed three (3) months and the retention of records of such inspections for two (2) years;
11.15.d. The applicant submits to the agency a description of the overall organizational structure pertaining to the industrial radiography program, including specified delegations of authority and responsibility for operation of the program;
11.15.e. The applicant who desires to conduct his own leak tests has established adequate procedures to be followed in testing sealed sources for possible leakage and contamination and submits to the agency a description of such procedures including:
11.15.e.1. Instrumentation to be used,
11.15.e.2. Method of performing tests, and
11.15.e.3. Pertinent experience of the individual who will perform the test; and
11.15.f. The registrant shall conduct a program for inspection and maintenance of radiographic exposure devices and storage containers to assure proper functioning of components important to safety.
11.16. Special Requirements for Specific Registrations of Broad Scope. This Section prescribes requirements for the issuance of specific registrations of broad scope for radioactive material and certain rules governing holders of such registrations.
11.16.a. The different types of broad scope registrations are set forth below:
11.16.a.1. A "Type A specific registration of broad scope" is a specific registration authorizing receipt, acquisition, ownership, possession, use and transfer of any chemical or physical form of the radioactive material specified in the registration, but not exceeding quantities specified in the registration, for any authorized purpose. The quantities specified are usually in the multicurie range.
11.16.a.2. A "Type B specific registration of broad scope" is a specific registration authorizing receipt, acquisition, ownership, possession, use and transfer of any chemical or physical form of radioactive material specified in Table 64-23 Aa, for any authorized purpose. The possession limit for a Type B registration of broad scope, if only one radionuclide is possessed thereunder, is the quantity specified for that radionuclide in Table 64-23 Aa, column I. If two or more radionuclides are possessed thereunder, the possession limit for each is determined as follows: For each radionuclide, determine the ratio of the quantity possessed to the applicable quantity specified in Table 64-23 Aa, Column I, for that radionuclide. The sum of the ratios for all radionuclides possessed under the registration shall not exceed unity.
11.16.a.3. A "Type C specific registration of broad scope" is a specific registration authorizing receipt, acquisition, ownership, possession, use, and transfer of any chemical or physical form of radioactive material specified in Table 64-23 Aa, for any authorized purpose. The possession limit for a Type C registration of broad scope, if only one radionuclide is possessed thereunder, is the quantity specified for that radionuclide in Table 64-23 Aa, column II. If two or more radionuclides are possessed thereunder, the possession limit is determined for each as follows: For each radionuclide, determine the ratio of the quantity possessed to the applicable quantity specified in Table 64-23 Aa, column ii, for that radionuclide. The sum of the ratios for all radionuclides possessed under the registration shall not exceed unity.
11.16.b. An application for a Type A specific registration of broad scope will be approved if:
11.16.b.1. The applicant satisfies the general requirements specified in Subsection 11.14.;
11.16.b.2. The applicant has engaged in a reasonable number of activities involving the use of radioactive material; and
11.16.b.3. The applicant has established administrative controls and provisions relating to organization and management, procedures, record keeping, material control and accounting, and management review that are necessary to assure safe operations, including:
11.16.b.3.A. The establishment of a radiation safety committee composed of such persons as a radiation safety officer, a representative of management, and persons trained and experienced in the safe use of radioactive material;
11.16.b.3.B. The appointment of a radiation safety officer who is qualified by training and experience in radiation protection, and who is available for advice and assistance on radiation safety matters; and
11.16.b.3.C. The establishment of appropriate administrative procedures to assure:
11.16.b.3.C.1. Control of procurement and use of radioactive material;
11.16.b.3.C.2. Completion of safety evaluations of proposed uses of radioactive material which take into consideration such matters as the adequacy of facilities and equipment, training and experience of the user, and the operating or handling procedures; and
11.16.b.3.C.3. Review, approval, and recording by the radiation safety committee of safety evaluations of proposed uses prepared in accordance with Part 11.16.b.3.C.2. prior to use of the radioactive material.
11.16.c. An application for a Type B specific registration of broad scope will be approved if:
11.16.c.1. The applicant satisfies the general requirements specified in Subsection 11.14.; and
11.16.c.2. The applicant has established administrative controls and provisions relating to organization and management, procedures, record keeping, material control and accounting, and management review that are necessary to assure safe operations, including:
11.16.c.2.A. The appointment of a radiation safety officer who is qualified by training and experience in radiation protection, and who is available for advice and assistance on radiation safety matters, and
11.16.c.2.B. The establishment of appropriate administrative procedures to assure,
11.16.c.2.B.1. Control of procurement and use of radioactive material,
11.16.c.2.B.2. Completion of safety evaluations of proposed uses of radioactive material which take into consideration such matters as the adequacy of facilities and equipment, training and experience of the user, and the operating or handling procedures, and
11.16.c.2.B.3. Review, approval, and recording by the radiation safety officer of safety evaluations of proposed uses prepared in accordance with Part 11.16.c.2.B.2. prior to use of the radioactive material.
11.16.d. An application for a type c specific registration of broad scope will be approved if:
11.16.d.1. The applicant satisfies the general requirements specified in Subsection 11.14.;
11.16.d.2. The applicant submits a statement that radioactive material will be used only by, or under the direct supervision of, individuals who have received:
11.16.d.2.A. A college degree at the bachelor level, or equivalent training and experience, in the physical or biological sciences or in engineering, and
11.16.d.2.B. At least forty (40) hours of training and experience in the safe handling of radioactive material, and in the characteristics of ionizing radiation, units of radiation dose and quantities, radiation detection instrumentation, and biological hazards of exposure to radiation appropriate to the type and forms of radioactive material to be used; and
11.16.d.3. The applicant has established administrative controls and provisions relating to procurement of radioactive material, procedures, record keeping, material control and accounting, and management review necessary to assure safe operations.
11.16.e. Specific registrations of broad scope are subject to the following conditions:
11.16.e.1. Unless specifically authorized, persons registered pursuant to Subsection 11.16. shall not:
11.16.e.1.A. Conduct tracer studies in the environment involving direct release of radioactive material;
11.16.e.1.B. Receive, acquire, own, possess, use, or transfer devices containing one hundred thousand (100,000) curies (three and seven-tenths (3.7) PBq) or more of radioactive material in sealed sources used for irradiation of materials;
11.16.e.1.C. Conduct activities for which a specific registration issued by the agency under Subsections 11.15., 11.17., or Section 12. of this rule is required; or
11.16.e.1.D. Add or cause the addition of radioactive material to any food, beverage, cosmetic, drug, or other product designed for ingestion or inhalation by, or application to, a human being.
11.16.e.2. Each Type A specific registration of broad scope issued under this Section shall be subject to the condition that radioactive material possessed under the registration may only be used by, or under the direct supervision of, individuals approved by the registrant's radiation safety committee.
11.16.e.3. Each Type B specific registration of broad scope issued under this Section shall be subject to the condition that radioactive material possessed under the registration may only be used by, or under the direct supervision of, individuals approved by the registrant's radiation safety officer.
11.16.e.4. Each type c specific registration of broad scope issued under this Section shall be subject to the condition that radioactive material possessed under the registration may only be used by, or under the direct supervision of, individuals who satisfy the requirements of Subdivision 11.16.d.
11.17. Special Requirements for a Specific Registration to Manufacture, Assemble, Repair, or Distribute Commodities, Products, or Devices Which Contain Radioactive Material
11.17.a. Registration of the Introduction of Radioactive Material into Products in Exempt Concentrations
11.17.a.1. In addition to the requirements set forth in Subsection 11.14., a specific registration authorizing the introduction of radioactive material into a product or material owned by or in the possession of the registrant or another to be transferred to persons exempt under Paragraph 11.3.a.1. will be issued if:
11.17.a.1.A. The applicant submits a description of the product or material into which the radioactive material will be introduced, intended use of the radioactive material and the product or material into which it is introduced, method of introduction, initial concentration of the radioactive material in the product or material, control methods to assure that no more than the specified concentration is introduced into the product or material, estimated time interval between introduction and transfer of the product or material, and estimated concentration of the radioactive material in the product or material at the time of transfer; and
11.17.a.1.B. The applicant provides reasonable assurance that the concentrations of radioactive material at the time of transfer will not exceed the concentrations in Table 64-23 Y, that reconcentration of the radioactive material in concentrations exceeding those in Table 64-23 Y is not likely, that use of lower concentrations is not feasible, and that the product or material is not likely to be incorporated in any food, beverage, cosmetic, drug or other commodity or product designed for ingestion or inhalation by, or application to, a human being.
11.17.a.1.C. Each person registered under Subdivision 11.17.a. shall file an annual report with the agency which shall identify the type and quantity of each product or material into which radioactive material has been introduced during the reporting period; name and address of the person who owned or possessed the product or material, into which radioactive material has been introduced, at the time of introduction; the type and quantity of radionuclide introduced into each such product or material; and the initial concentrations of the radionuclide in the product or material at time of transfer of the radioactive material by the registrant. If no transfers of radioactive material have been made pursuant to Subdivision 11.17.a. during the reporting period, the report shall so indicate. The report shall cover the year ending June 30, and shall be filed within thirty (30) days thereafter.
11.17.b. Registration of the Distribution of Radioactive Material in Exempt Quantities.
11.17.b.1. An application for a specific registration to distribute NARM to persons exempted from this rule pursuant to Subdivision 11.3.b. will be approved if:
11.17.b.1.A. The radioactive material is not contained in any food, beverage, cosmetic, drug, or other commodity designed for ingestion or inhalation by, or application to, a human being;
11.17.b.1.B. The radioactive material is in the form of processed chemical elements, compounds, or mixtures, tissue samples, bioassay samples, counting standards, plated or encapsulated sources, or similar substances, identified as radioactive and to be used for its radioactive properties, but is not incorporated into any manufactured or assembled commodity, product, or device intended for commercial distribution; and
11.17.b.1.C. The applicant submits copies of prototype labels and brochures and the agency approves such labels and brochures.
11.17.b.2. The registration issued under Paragraph 11.17.b.1. is subject to the following conditions:
11.17.b.2.A. No more than 10 exempt quantities shall be sold or transferred in any single transaction. However, an exempt quantity may be composed of fractional parts of one or more of the exempt quantity provided the sum of the fractions shall not exceed unity.
11.17.b.2.B. Each exempt quantity shall be separately and individually packaged. No more than 10 such packaged exempt quantities shall be contained in any outer package for transfer to persons exempt pursuant to Subdivision 11.3.b. The outer package shall be such that the dose rate at the external surface of the package does not exceed five-tenths (0.5) millirem (five [5] Sv) per hour.
11.17.b.2.C. The immediate container of each quantity or separately packaged fractional quantity of radioactive material shall bear a durable, legible label which:
11.17.b.2.C.1. Identifies the radionuclide and the quantity of radioactivity, and
11.17.b.2.C.2. Bears the words "radioactive material".
11.17.b.2.D. In addition to the labeling information required by Subparagraph 11.17.b.2.C., the label affixed to the immediate container, or an accompanying brochure, shall:
11.17.b.2.D.1. State that the contents are exempt from registration requirements,
11.17.b.2.D.2. Bear the words "radioactive material - not for human use - introduction into foods, beverages, cosmetics, drugs, or medicinals, or into products manufactured for commercial distribution is prohibited--exempt quantities should not be combined", and
11.17.b.2.D.3. Set forth appropriate additional radiation safety precautions and instructions relating to the handling, use, storage, and disposal of the radioactive material.
11.17.b.3. Each person registered under Subdivision 11.17.b. shall maintain records identifying, by name and address, each person to whom radioactive material is transferred for use under Subdivision 11.17.b. or the equivalent rules of a licensing state, and stating the kinds and quantities of radioactive material transferred. An annual summary report stating the total quantity of each radionuclide transferred under the specific registration shall be filed with the agency. Each report shall cover the year ending June 30, and shall be filed within thirty (30) days thereafter. If no transfers of radioactive material have been made pursuant to Subdivision 11.17.b. during the reporting period, the report shall so indicate.
11.17.c. Registration of the Incorporation of Naturally Occurring and Accelerator-Produced Radioactive Material into Gas and Aerosol Detectors. An application for a specific registration authorizing the incorporation of narm into gas and aerosol detectors to be distributed to persons exempt under Paragraph 11.3.c.3. will be approved if the application satisfies requirements equivalent to those contained in Section 32.26 of 10 CFR Part 32. The maximum quantity of radium-226 in each device shall not exceed one-tenth (0.1) microcurie (three and seven-tenths [3.7] kBq).
11.17.d. Registration of the Manufacture and Distribution of Devices to Persons Generally Registered Under Subdivision 11.7.b.
11.17.d.1. An application for a specific registration to manufacture or distribute devices containing radioactive material, excluding special nuclear material, to persons generally registered under Subdivision 11.7.b. or equivalent rules of the NRC, an agreement state, or a licensing state will be approved if:
11.17.d.1.A. The applicant satisfies the general requirements of Subsection 11.14.;
11.17.d.1.B. The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control, labels, proposed uses, installation, servicing, leak testing, operating and safety instructions, and potential hazards of the device to provide reasonable assurance that:
11.17.d.1.B.1. The device can be safely operated by persons not having training in radiological protection,
11.17.d.1.B.2. Under ordinary conditions of handling, storage, and use of the device, the radioactive material contained in the device will not be released or inadvertently removed from the device, and it is unlikely that any person will receive in any period of one (1) calendar quarter a dose in excess of ten (10) percent of the limits specified in Subsection 6.4.a. of this rule, and
11.17.d.1.B.3. Under accident conditions such as fire and explosion associated with handling, storage, and use of the device, it is unlikely that any person would receive an external radiation dose or dose commitment in excess of the organ doses listed in Table 64-23 Ll column III: and
11.17.d.1.C. Each device bears a durable, legible, clearly visible label or labels approved by the agency, which contain in a clearly identified and separate statement:
11.17.d.1.C.1. Instructions and precautions necessary to assure safe installation, operation, and servicing of the device; documents such as operating and service manuals may be identified in the label and used to provide this information,
11.17.d.1.C.2. The requirement, or lack of requirement, for leak testing, or for testing any "on-off" mechanism and indicator, including the maximum time interval for such testing, and the identification of radioactive material by isotope, quantity of radioactivity, and date of determination of the quantity, and
11.17.d.1.C.3. The information called for in one of the following statements, as appropriate, in the same or substantially similar form: 11.17.d.1.C.3.(a) The receipt, possession, use, and transfer of this device, Model___________, Serial No.____________10, are subject to a general registration or the equivalent and the rules of the NRC or a state with which the NRC has entered into an agreement for the exercise of regulatory authority. This label shall be maintained on the device in a legible condition. Removal of this label is prohibited.
CAUTION - RADIOACTIVE MATERIAL
Name of manufacturer or distributor 11.17.d.1.C.3.(b) The receipt, possession, use, and transfer of this device, Model__________, Serial No.___________4/, are subject to a general registration or the equivalent, and the rules of a licensing state. This label shall be maintained on the device in a legible condition. Removal of this label is prohibited.
CAUTION - RADIOACTIVE MATERIAL
Name of manufacturer or distributor
11.17.d.2. In the event the applicant desires that the device be required to be tested at intervals longer than 6 months, either for proper operation of the "on-off" mechanism and indicator, if any, or for leakage of radioactive material or for both, the applicant shall include in the application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the device or similar devices and by design features which have a significant bearing on the probability or consequences of leakage of radioactive material from the device or failure of the "on-off" mechanism and indicator. In determining the acceptable interval for the test for leakage of radioactive material, the agency will consider information which includes, but is not limited to:
11.17.d.2.A. Primary containment or source capsule;
11.17.d.2.B. Protection of primary containment;
11.17.d.2.C. Method of sealing containment;
11.17.d.2.D. Containment construction materials;
11.17.d.2.E. Form of contained radioactive material;
11.17.d.2.F. Maximum temperature withstood during prototype tests;
11.17.d.2.G. Maximum pressure withstood during prototype tests;
11.17.d.2.H. Maximum quantity of contained radioactive material;
11.17.d.2.I. Radiotoxicity of contained radioactive material; and
11.17.d.2.J. Operating experience with identical devices or similarly designed and constructed devices.
11.17.d.3. In the event the applicant desires that the general registration under Subdivision 11.7.b. , or under equivalent rules of the NRC, an agreement state, or a licensing state be authorized to install the device, collect the sample to be analyzed by a specific registration for leakage of radioactive material, service the device, test the "on-off" mechanism and indicator, or remove the device from installation, the applicant shall include in the application written instructions to be followed by the general registration, estimated calendar quarter doses associated with such activity or activities, and basis for such estimates. The submitted information shall demonstrate that performance of such activity or activities by an individual untrained in radiological protection, in addition to other handling, storage, and use of devices under the general registration, is unlikely to cause that individual to receive a calendar quarter dose in excess of ten (10) percent of the limits specified in Subsection 6.4. of this rule.
11.17.d.4. Each person registered under Subdivision 11.17.d. to distribute devices to generally registered persons shall:
11.17.d.4.A. Furnish a copy of the general registration contained in Subdivision 11.7.d. to each person to whom he directly or through an intermediate person transfers radioactive material in a device for use pursuant to the general registration contained in Subdivision 11.7.d.;
11.17.d.4.B. Furnish a copy of the general registration contained in the NRC's, agreement state's, or licensing state's rule equivalent to Subdivision 11.7.d., or alternatively, furnish a copy of the general registration contained in Subdivision 11.7.d. to each person to whom he directly or through an intermediate person transfers radioactive material in a device for use pursuant to the general registration of the NRC, the agreement state, or the licensing state. If a copy of the general registration in use of the device is regulated by the NRC, agreement state, or licensing state under requirements Subdivision 11.7.d. is furnished to such a person, it shall be accompanied by a note explaining that the substantially the same as those in Subdivision 11.7.d.;
11.17.d.4.C. Report to the agency all transfers of such devices to persons for use under the general registration in Subdivision 11.7.d. Such report shall identify each general registration by name and address, an individual by name and position who may constitute a point of contact between the agency and the general registration, the type and model number of device transferred, and the quantity and type of radioactive material contained in the device. If one or more intermediate persons will temporarily possess the device at the intended place of use prior to its possession by the user, the report shall include identification of each intermediate person by name, address, contact, and relationship to the intended user. If no transfers have been made to persons generally registered under Subdivision 11.7.d. during the reporting period, the report shall so indicate. The report shall cover each calendar quarter and shall be filed within thirty (30) days thereafter;
11.17.d.4.D. Furnish reports to other agencies.
11.17.d.4.D.1. Report to the NRC all transfers of such devices to persons for use under the NRC general registration in Section 31.5 of 10 CFR Part 31.
11.17.d.4.D.2. Report to the responsible State agency all transfers of devices manufactured and distributed pursuant to Subdivision 11.17.d. for use under a general registration in that state's rules equivalent to Subdivision 11.7.d.
11.17.d.4.D.3. Such reports shall identify each general registration by name and address, an individual by name and position who may constitute a point of contact between the agency and the general registration, the type and model of the device transferred, and the quantity and type of radioactive material contained in the device. If one or more intermediate persons will temporarily possess the device at the intended place of use prior to its possession by the user, the report shall include identification of each intermediate person by name, address, contact, and relationship to the intended user. The report shall be submitted within thirty (30) days after the end of each calendar quarter in which such a device is transferred to the generally registered person.
11.17.d.4.D.4. If no transfers have been made to NRC registrants during the reporting period, this information shall be reported to the NRC.
11.17.d.4.D.5. If no transfers have been made to general registrations within a particular state during the reporting period, this information shall be reported to the responsible state agency upon request of that agency; and
11.17.d.4.E. Keep records showing the name, address, and the point of contact for each general registration to whom he directly or through an intermediate person transfers radioactive material in devices for use pursuant to the general registration provided in Subdivision 11.7.b., or equivalent rules of the NRC, an agreement state, or a licensing state. The records shall show the date of each transfer, the radionuclide and the quantity of radioactivity in each device transferred, the identity of any intermediate person, and compliance with the report requirements of subpart 11.17.d.1.C.
11.17.e. Special Requirements for the Manufacture, Assembly, or Repair of Luminous Safety Devices for Use in Aircraft. An application for a specific registration to manufacture, assemble, or repair luminous safety devices containing tritium or Promethium-147 for use in aircraft, for distribution to persons generally registered under Subsection 11.8. will be approved if:
11.17.e.1. The applicant satisfies the general requirements specified in Subsection 11.14.; and
11.17.e.2. The applicant satisfies the requirements of Sections 32.53, 32.54, 32.55, 32.56, and 32.101 of 10 CFR Part 32, or their equivalent.
11.17.f. Special Requirements for Registration to Manufacture Calibration Sources Containing Americium-241, Plutonium or Radium-226 for Distribution to Persons Generally Registered Under Subsection 11.10. An application for a specific registration to manufacture calibration and reference sources containing Americium-241, plutonium or Radium-226 to persons generally registered under Subsection 11.10. will be approved if:
11.17.f.1. The applicant satisfies the general requirement of Subsection 11.14.; and
11.17.f.2. The applicant satisfies the requirements of Sections 32.57, 32.58, 32.59, and 32.102 of 10 CFR Part 32 and Section 70.39 of 10 CFR Part 70 or their equivalent.
11.17.g. Manufacture and Distribution of Radioactive Material for Certain In Vitro Clinical or Laboratory Testing Under General Registration. An application for a specific registration to manufacture or distribute radioactive material for use under the general registration of Subsection 11.11. will be approved if:
11.17.g.1. The applicant satisfies the general requirements specified in Subsection 11.14.
11.17.g.2. The radioactive material is to be prepared for distribution in prepackaged units of:
11.17.g.2.A. Carbon-14 in units not exceeding ten (10) microcuries (three hundred seventy [370] kBq) each.
11.17.g.2.B. Cobalt-57 in units not exceeding ten (10) microcuries (three hundred seventy [370] kBq) each.
11.17.g.2.C. Hydrogen-3 (tritium) in units not exceeding fifty (50) microcuries (one and eighty five one-hundredths [1.85] MBq) each.
11.17.g.2.D. Iodine-125 in units not exceeding ten (10) microcuries (three hundred seventy [370] kBq) each.
11.17.g.2.E. Mock iodine-125 in units not exceeding five one-hundredths (0.05) microcurie (one and eighty five one-hundredths [1.85] kBq) of iodine-129 and five one-thousandths (0.005) microcurie (one hundred eighty five one-hundredths [185] Bq) of americium-241 each.
11.17.g.2.F. Iodine-131 in units not exceeding ten (10) microcuries (three hundred seventy [370] kBq) each.
11.17.g.2.G. Iron-59 in units not exceeding twenty (20) microcuries (seven hundred forty [740] kBq) each.
11.17.g.2.H. Selenium-75 in units not exceeding ten (10) microcuries (three hundred seventy [370] kBq) each.
11.17.g.3. Each prepackaged unit bears a durable, clearly visible label:
11.17.g.3.A. Identifying the radioactive contents as to chemical form and radionuclide, and indicating that the amount of radioactivity does not exceed ten (10) microcuries (three hundred seventy [370] kBq) of Iodine-125, Iodine-131, Carbon-14, Cobalt-57, or Selenium-75; fifty (50) microcuries (one and eighty five one-hundredths [1.85] MBq) of Hydrogen-3 (tritium); twenty (20) microcuries (seven hundred forty [740] kBq) of Iron-59; or mock Iodine-125 in units not exceeding five one-hundredths (0.05) microcurie (one and eighty five one-hundredths [1.85] kBq) of Iodine-129 and five one-thousandths (0.005) microcurie (one hundred eighty five [185] Bq) of Americium-241 each; and
11.17.g.3.B. Displaying the radiation caution symbol described in Subsection 6.7. and the words, "CAUTION, RADIOACTIVE MATERIAL", and "Not for Internal or External Use in Humans or Animals".
11.17.g.4. One of the following statements, as appropriate, or a substantially similar statement which contains the information called for in one of the following statements, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure which accompanies the package:
11.17.g.4.A. This radioactive material may be received, acquired, possessed, and used only by physicians, veterinarians, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the rules and a general registration of the NRC or of a state with which the NRC has entered into an agreement for the exercise of regulatory authority. ______________________ Name of manufacturer
11.17.g.4.B. This radioactive material may be received, acquired, possessed, and used only by physicians, veterinarians, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the rules and a general registration of a licensing state. ______________________ Name of manufacturer
11.17.g.5. The label affixed to the unit, or the leaflet or brochure which accompanies the package, contains adequate information as to the precautions to be observed in handling and storing such radioactive material. In the case of the mock Iodine-125 reference or calibration source, the information accompanying the source must also contain directions to the registrant regarding the waste disposal requirements set out in Subsection 6.7. of this rule.
11.17.h. Registration of the Manufacture and Distribution of Ice Detection Devices. An application for a specific registration to manufacture and distribute ice detection devices to persons generally registered under Subsection 11.12. will be approved if:
11.17.h.1. The applicant satisfies the general requirements of Subsection 11.14.; and
11.17.h.2. The criteria of Sections 32.61, 32.62, and 32.103 of 10 CFR Part 32 are met.
11.17.i. Manufacture and Distribution of Radiopharmaceuticals Containing Radioactive Material for Medical Use Under Group Registrants. An application for a specific registration to manufacture and distribute radiopharmaceuticals containing radioactive material for use by persons registered pursuant to this Section for the uses listed in Subsections 11.30., 11.32., and 11.36. of this rule will be approved if:
11.17.i.1. The applicant satisfies the general requirements specified in Subsection 11.14. of this Section;
11.17.i.2. The applicant submits evidence that:
11.17.i.2.A. The radiopharmaceutical containing radioactive material will be manufactured, labeled, and packaged in accordance with the Federal Food, Drug and Cosmetic Act or the Public Health Service Act, such as a new drug application (NDA) approved by the Food and Drug Administration (FDA), or a "notice of claimed investigational exemption for a new drug" (IND) that has been accepted by the FDA, or
11.17.i.2.B. The manufacture and distribution of the radiopharmaceutical containing radioactive material is not subject to the Federal Food, Drug and Cosmetic Act and the Public Health Service Act;
11.17.i.3. The applicant submits information on the radionuclide, chemical and physical form, packaging including maximum activity per package, and shielding provided by the packaging of the radioactive material which is appropriate for safe handling and storage of radiopharmaceuticals by group registrations; and
11.17.i.3.A. The label affixed to each package of the radiopharmaceutical contains information on the radionuclide, quantity, and date of assay and the label affixed to each package, or the leaflet or brochure which accompanies each package, contains a statement that the radiopharmaceutical is registered by the agency for distribution to persons registered pursuant to this Section for the uses listed in 11.17.i.
11.17.i.3.B. The labels, leaflets, or brochures required by Paragraph 11.17.i.3.A. are in addition to the labeling required by the Food and Drug Administration (FDA) and they may be separate from or, with the approval of FDA, may be combined with the labeling required by FDA.
11.17.j. Manufacture and Distribution of Generators or Reagent Kits for Preparation of Radiopharmaceuticals Containing Radioactive Material.11 An application for a specific registration to manufacture and distribute generators or reagent kits containing radioactive material for preparation of radiopharmaceuticals by persons registered pursuant to this Section for the uses listed in Subsection 11.32. of this rule will be approved if:
11.17.j.1. The applicant satisfies the general requirements specified in Subsection 11.25.;
11.17.j.2. The applicant submits evidence that:
11.17.j.2.a. The generator or reagent kit is to be manufactured, labeled and packaged in accordance with the Federal Food, Drug and Cosmetic Act or the Public Health Service Act, such as a new drug application (NDA) approved by the Food and Drug Administration (FDA), or a "notice of claimed investigational exemption for a new drug" (IND) that has been accepted by the FDA, or
11.17.j.2.B. The manufacture and distribution of the generator or reagent kit are not subject to the Federal Food, Drug and Cosmetic Act and the Public Health Service Act;
11.17.j.3. The applicant submits information on the radionuclide, chemical and physical form, packaging including maximum activity per package, and shielding provided by the packaging of the radioactive material contained in the generator or reagent kit;
11.17.j.4. The label affixed to the generator or reagent kit contains information on the radionuclide, quantity, and date of assay; and
11.17.j.5. The label affixed to the generator or reagent kit, or the leaflet or brochure which accompanies the generator or reagent kit, contains:
11.17.j.5.A. Adequate information, from a radiation safety standpoint, on the procedures to be followed and the equipment and shielding to be used in eluting the generator or processing radioactive material with the reagent kit, and
11.17.j.5.B. A statement that this generator or reagent kit, as appropriate, is approved for use by persons registered by the agency pursuant to Subsection 11.32. of this rule or under equivalent licenses of the NRC, an agreement state, or a licensing state. The labels, leaflets, or brochures required by Subdivision 11.17.j. are in addition to the labeling required by the Food and Drug Administration (FDA) and they may be separate from or, with the approval of FDA, may be combined with the labeling required by FDA.
11.17.k. Manufacture and Distribution of Sources or Devices Containing Radioactive Material for Medical Use. An application for a specific registration to manufacture and distribute sources and devices containing radioactive material to persons registered pursuant to Section 12. for use as a calibration or reference source or for the uses listed in Subsections 12.40 and 12.42. of this rule will be approved if:
11.17.k.1. The applicant satisfies the general requirements in Subsection 11.14. of this Section;
11.17.k.2. The applicant submits sufficient information regarding each type of source or device pertinent to an evaluation of its radiation safety, including:
11.17.k.2.A. The radioactive material contained, its chemical and physical form, and amount,
11.17.k.2.B. Details of design and construction of the source or device,
11.17.k.2.C. Procedures for, and results of, prototype tests to demonstrate that the source or device will maintain its integrity under stresses likely to be encountered in normal use and accidents,
11.17.k.2.D. For devices containing radioactive material, the radiation profile of a prototype device,
11.17.k.2.E. Details of quality control procedures to assure that production sources and devices meet the standards of the design and prototype tests,
11.17.k.2.F. Procedures and standards for calibrating sources and devices,
11.17.k.2.G. Legend and methods for labeling sources and devices as to their radioactive content, and
11.17.k.2.H. Instructions for handling and storing the source or device from the radiation safety standpoint; these instructions are to be included on a durable label attached to the source or device or attached to a permanent storage container for the source or device; provided, that instructions which are too lengthy for such label may be summarized on the label and printed in detail on a brochure which is referenced on the label;
11.17.k.3. The label affixed to the source or device, or to the permanent storage container for the source or device, contains information on the radionuclide, quantity, and date of assay, and a statement that the source or device is registered by the agency for distribution to persons registered pursuant to Section 12. and Subsections 12.40. and 12.42. of this rule or under equivalent licenses of the NRC, an agreement state, or a licensing state, provided that such labeling for sources which do not require long term storage may be on a leaflet or brochure which accompanies the source;
11.17.k.4. In the event the applicant desires that the source or device be required to be tested for leakage of radioactive material at intervals longer than six (6) months, he shall include in his application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the source or device or similar sources or devices and by design features that have a significant bearing on the probability or consequences of leakage of radioactive material from the source; and
11.17.k.5. In determining the acceptable interval for test of leakage of radioactive material, the agency will consider information that includes, but is not limited to:
11.17.k.5.A. Primary containment or source capsule,
11.17.k.5.B. Protection of primary containment,
11.17.k.5.C. Method of sealing containment,
11.17.k.5.D. Containment construction materials,
11.17.k.5.E. Form of contained radioactive material,
11.17.k.5.F. Maximum temperature withstood during prototype tests,
11.17.k.5.G. Maximum pressure withstood during prototype tests,
11.17.k.5.H. Maximum quantity of contained radioactive material,
11.17.k.5.I. Radiotoxicity of contained radioactive material, and
11.17.k.5.J. Operating experience with identical sources or devices or similarly designed and constructed sources or devices.
11.17.l. Requirements for Registration to Manufacture and Distribute Industrial Products Containing Depleted Uranium for Mass-Volume Applications
11.17.l.1. An application for a specific registration to manufacture industrial products and devices containing depleted uranium for use pursuant to Subdivision 11.5.d. equivalent rules of the NRC or an agreement state will be approved if:
11.17.l.1.A. The applicant satisfies the general requirements specified in Subsection 11.14.;
11.17.l.1.B. The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control procedures, labeling or marking, proposed uses, and potential hazards of the industrial product or device to provide reasonable assurance that possession, use, or transfer of the depleted uranium in the product or device is not likely to cause any individual to receive in any period of one (1) calendar quarter a radiation dose in excess of ten (10) percent of the limits specified in Subsection 6.4. of this rule; and
11.17.l.1.C. The applicant submits sufficient information regarding the industrial product or device and the presence of depleted uranium for a mass-volume application in the product or device to provide reasonable assurance that unique benefits will accrue to the public because of the usefulness of the product or device.
11.17.l.2. In the case of an industrial product or device whose unique benefits are questionable, the agency will approve an application for a specific registration under Subdivision 11.17.l. only if the product or device is found to combine a high degree of utility and low probability of uncontrolled disposal and dispersal of significant quantities of depleted uranium into the environment.
11.17.l.3. The agency may deny any application for a specific registration under Subdivision 11.17.l. if the end uses of the industrial product or device cannot be reasonably foreseen.
11.17.l.4. Each person registered pursuant to Subdivision 11.17.l. shall:
11.17.l.4.A. Maintain the level of quality control required by the registration in the manufacture of the industrial product or device, and in the installation of the depleted uranium into the product or device;
11.17.l.4.B. Label or mark each unit to:
11.17.l.4.B.1. Identify the manufacturer of the product or device and the number of the registration under which the product or device was manufactured, the fact that the product or device contains depleted uranium, and the quantity of depleted uranium in each product or device; and
11.17.l.4.B.2. State that the receipt, possession, use, and transfer of the product or device are subject to a general registration or the equivalent and the rules of the NRC or an agreement state;
11.17.l.4.C. Assure that the depleted uranium before being installed in each product or device has been impressed with the following legend clearly legible through any plating or other covering: "depleted uranium";
11.17.l.4.C.1. Furnish a copy of the general registration contained in Subdivision 11.5.d. and a copy of Agency Form W to each person to whom he transfers depleted uranium in a product or device for use pursuant to the general registration contained in Subdivision 11.5.d., or
11.17.l.4.C.2. Furnish a copy of the general registration contained in the NRC's or agreement state's rule equivalent to Subdivision 11.5.d. and a copy of the NRC's or agreement state's certificate, or alternatively, furnish a copy of the general registration contained in Subdivision 11.5.d. and a copy of Agency Form W to each person to whom he transfers depleted uranium in a product or device for use pursuant to the general registration of the NRC or an agreement state, with a note explaining that use of the product or device is regulated by the NRC or an agreement state under requirements substantially the same as those in Subdivision 11.5.d.;
11.17.l.4.D. Report to the agency all transfers of industrial products or devices to persons for use under the general registration in Subdivision 11.5.d. Such report shall identify each general registration by name and address, an individual by name and position who may constitute a point of contact between the agency and the general registration, the type and model number of device transferred, and the quantity of depleted uranium contained in the product or device. The report shall be submitted within thirty (30) days after the end of each calendar quarter in which such a product or device is transferred to the generally registered person. If no transfers have been made to persons generally registered under Subdivision 11.5.d. during the reporting period, the report shall so indicate;
11.17.l.4.D.1. Report to the NRC all transfers of industrial products or devices to persons for use under the NRC general registration in Section 40.25 of 10 CFR Part 40,
11.17.l.4.D.2. Report to the responsible state agency all transfers of devices manufactured and distributed pursuant to Subdivision 11.17.l. for use under a general registration in that state's rules equivalent to Subdivision 11.5.d.,
11.17.l.4.D.3. Such report shall identify each general registration by name and address, an individual by name and position who may constitute a point of contact between the agency and the general registration, the type and model number of the device transferred, and the quantity of depleted uranium contained in the product or device. The report shall be submitted within thirty (30) days after the end of each calendar quarter in which such product or device is transferred to the generally registered person,
11.17.l.4.D.4. If no transfers have been made to NRC registrants during the reporting period, this information shall be reported to the NRC, and
11.17.l.4.D.5. If no transfers have been made to general registrations within a particular agreement state during the reporting period, this information shall be reported to the responsible agreement state agency upon the request of that agency; and
11.17.l.4.D.6. Keep records showing the name, address, and point of contact for each general registration to whom he transfers depleted uranium in industrial products or devices for use pursuant to the general registration provided in Subdivision 11.5.d. or equivalent rules of the NRC or an agreement state. The records shall be maintained for a period of two (2) years and shall show the date of each transfer, the quantity of depleted uranium in each product or device transferred, and compliance with the report requirements of this Section.
11.18. Issuance of Specific Registrations
11.18.a. Upon a determination that an application meets the requirements of this rule and the rules of the agency, the agency will issue a specific registration authorizing the proposed activity in such form and containing such conditions and limitations as it deems appropriate or necessary.
11.18.b. The agency may incorporate in any registration at the time of issuance, or thereafter by appropriate rule, or order, such additional requirements and conditions with respect to the registration's receipt, possession, use, and transfer of radioactive material subject to this Section as it deems appropriate or necessary in order to:
11.18.b.1. Minimize danger to public health and safety or property;
11.18.b.2. Require such reports and the keeping of such records, and to provide for such inspections of activities under the registration as may be appropriate or necessary; and
11.18.b.3. Prevent loss or theft of material subject to this Section.
11.19. Specific Terms and Conditions of Registrations
11.19.a. Each registration issued pursuant to this Section shall be subject to all the provisions of this rule, now or hereafter in effect, and to all rules, and orders of the agency.
11.19.b. No registration issued or granted under this Section and no right to possess or utilize radioactive material granted by any registration issued pursuant to this Section shall be transferred, assigned, or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of any registration to any person unless the agency shall, after securing full information find that the transfer is in accordance with the provisions of the act, now or hereafter in effect, and to all valid rules, and orders of the agency, and shall give its consent in writing.
11.19.c. Each person registered by the agency pursuant to this Section shall confine use and possession of the material registered to the locations and purposes authorized in the registration.
11.19.d. Each registrant shall notify the agency in writing when the registrant decides to permanently discontinue all activities involving materials authorized under the registration.
11.19.e. Each registrant shall notify the agency in writing immediately following the filing of a voluntary or involuntary petition for bankruptcy under any Chapter of Title 11 (bankruptcy) of the United States Code by or against:
11.19.e.1. The registrant;
11.19.e.2. An entity (as that term is defined in 11 U.S.C. 101(14)) controlling the registrant or listing the registration or registrant as property of the estate; or
11.19.e.3. An affiliate (as that term is defined in 11 U.S.C. 101(2)) of the registrant.
11.19.f. The notification specified in Subdivision 11.19.e. shall indicate the bankruptcy court in which the petition for bankruptcy was filed and the date of the filing of the petition.
11.20. Expiration and Termination of Registrations
11.20.a. Except as provided in Subdivision 11.21.b., each specific registration shall expire at the end of the specified day in the month and year stated therein.
11.20.b. Each registrant shall notify the agency immediately, in writing, and request termination of the registration when the registrant decides to terminate all activities involving radioactive material authorized under the registration. This notification and request for termination of the registration must include the reports and information specified in Paragraphs 11.20.d.4. and 5.
11.20.c. No less than thirty (30) days before the expiration date specified in the registration, the registrant shall either:
11.20.c.1. Submit an application for registration renewal under Subsection 11.21.; or
11.20.c.2. Notify the agency, in writing, if the registrant decides not to renew the registration.
11.20.d. If a registrant does not submit an application for registration renewal under Subsection 11.21., the registrant shall, on or before the expiration date specified in the registration:
11.20.d.1. Terminate use of radioactive material;
11.20.d.2. Remove radioactive contamination to the extent practicable;
11.20.d.3. Properly dispose of radioactive material;
11.20.d.4. Submit a completed agency form t; and
11.20.d.5. Submit a radiation survey report to confirm the absence of radioactive material or to establish the levels of residual radioactive contamination, unless the registrant demonstrates the absence of residual radioactive contamination in some other manner. The registrant shall, as appropriate:
11.20.d.5.A. Report levels of radiation in units of microrads per hour of beta and gamma radiation at 1 centimeter and gamma radiation at 1 meter from surfaces and report levels of radioactivity, including alpha, in units of transformations per minute (or microcuries) per one hundred (100) square centimeters removable and fixed on surfaces, microcuries per milliliter in water, and picocuries per gram in contaminated solids such as soils or concrete; and
11.20.d.5.B. Specify the instrumentation used and certify that each instrument was properly calibrated and tested.
11.20.d.6. If no residual radioactive contamination attributable to activities conducted under the registration is detected, the registrant shall submit a certification that no detectable radioactive contamination was found. The agency will notify the registrant, in writing, of the termination of the registration.
11.20.d.7. If detectable levels of residual radioactive contamination attributable to activities conducted under the registration are found, the registration continues in effect beyond the expiration date, if necessary, with respect to possession of residual radioactive material present as contamination until the agency notifies the registrant in writing that the registration is terminated. During this time the registrant is subject to the provisions of Subdivision 11.20.e.
11.20.d.8. In addition to the information submitted under Paragraphs 11.20.d.4. and 11.20.d.5., the registrant shall submit a plan for decontamination, if required, as regards residual radioactive contamination remaining at the time the registration expires.
11.20.e. Each registrant who possesses residual radioactive material under Paragraph 11.20.d.7., following the expiration date specified in the registration shall:
11.20.e.1. Limit actions involving radioactive material to those related to decontamination and other activities related to preparation for release for unrestricted use; and
11.20.e.2. Continue to control entry to restricted areas until they are suitable for release for unrestricted use and the agency notifies the registrant in writing that the registration is terminated.
11.21. Renewal of Registrations
11.21.a. Applications for renewal of specific registrations shall be filed in accordance with Subsection 11.13.
11.21.b. In any case in which a registrant, not less than thirty (30) days prior to expiration of his existing registration, has filed an application in proper form for renewal or for a new registration authorizing the same activities, such existing registration shall not expire until final action by the agency.
11.22. Amendment of Registrations at Request of Registrant. Applications for amendment of a registration shall be filed in accordance with Subsection 11.13. and shall specify the respects in which the registrant desires the registration to be amended and the grounds for such amendment.
11.23. Agency Action on Applications to Renew or Amend. In considering an application by a registrant to renew or amend the registration, the agency will apply the criteria set forth in Subsections 11.14., 11.15.,11.16.,and 11.17 and in Sections 8., 12. and 15. this rule, as applicable.
11.24. Persons Possessing a Registration for Source, Byproduct, or Special Nuclear Material in Quantities Not Sufficient to Form a Critical Mass on Effective Date of This rule. Any person who, on the effective date of this rule, possesses a general or specific registration for source, byproduct, or special nuclear material in quantities not sufficient to form a critical mass, issued by the NRC, shall be deemed to possess a like registration issued under this Section and this rule, such registration to expire either ninety (90) days after receipt from the agency of a notice of expiration of such registration, or on the date or expiration specified in the NRC registration, whichever is earlier.
11.25. Persons Possessing Naturally Occurring and Accelerator-Produced Radioactive Material (NARM) on Effective Date of This rule. Any person who, on the effective date of this rule, possesses narm for which a specific registration is required by this rule or this Section shall be deemed to possess such a registration issued under this rule and this Section. Such registration shall expire ninety (90) days after the effective date of this rule; provided, however, that if within the ninety (90) days the person possessing such material files an application in proper form for a registration, such existing registration shall not expire until the application has been finally determined by the agency.
11.26. Transfer of Material
11.26.a. No registrant shall transfer radioactive material except as authorized pursuant to Subsection 11.26.
11.26.b. Except as otherwise provided in his registration and subject to the provisions of Subdivisions 11.26.c. and 11.26.d., any registrant may transfer radioactive material:
11.26.b.1. To the agency;
11.26.b.2. To the U.S. department of energy;
11.26.b.3. To any person exempt from this rule to the extent permitted under such exemption;
11.26.b.4. To any person authorized to receive such material under terms of a general registration or its equivalent, or a specific registration or equivalent registration document, issued by the agency, the NRC, any agreement state or any licensing state, or to any person otherwise authorized to receive such material by the federal government or any agency thereof, the agency, an agreement state or a licensing state; or
11.26.b.5. As otherwise authorized by the agency in writing.
11.26.c. Before transferring radioactive material to a specific registration of the agency, the NRC, an agreement state or a licensing state, or to a general registration who is required to register with the agency, the NRC, an agreement state or a licensing state prior to receipt of the radioactive material, the registrant transferring the material shall verify that the transferee's registration authorizes the receipt of the type, form, and quantity of radioactive material to be transferred.
11.26.d. Any of the following methods for the verification required by Subdivision 11.26.c. is acceptable:
11.26.d.1. The transferor may possess and read a current copy of the transferee's specific registration or registration certificate.
11.26.d.2. The transferor may possess a written certification by the transferee that the transferee is authorized by registration or registration certificate to receive the type, form, and quantity of radioactive material to be transferred, specifying the registration or registration certificate number, issuing agency, and expiration date.
11.26.d.3. For emergency shipments, the transferor may accept oral certification by the transferee that the transferee is authorized by registration or registration certificate to receive the type, form, and quantity of radioactive material to be transferred, specifying the registration or registration certificate number, issuing agency, and expiration date; provided, that the oral certification is confirmed in writing within ten (10) days.
11.26.d.4. The transferor may obtain other information compiled by a reporting service from official records of the agency, the NRC, an agreement state, or a licensing state regarding the identity of registrants and the scope and expiration dates of licenses and registration.
11.26.d.5. When none of the methods of verification described in Paragraphs 11.26.d.1. through 4. are readily available or when a transferor desires to verify that information received by one of such methods is correct or up-to-date, the transferor may obtain and record confirmation from the agency, the NRC, or an agreement state, or a licensing state that the transferee is registered to receive the radioactive material.
11.26.e. Shipment and transport of radioactive material shall be in accordance with the provisions of Section 15. of this rule.
11.27. Modification and Revocation of Registrations
11.27.a. The terms and conditions of all registrations shall be subject to amendment, revision, or modification or the registration may be suspended or revoked by reason of amendments to this rule, or by reason of rules, rules, and orders issued by the agency.
11.27.b. Any registration may be revoked, suspended, or modified, in whole or in part, for any material false statement in the application or any statement of fact required under provisions of this rule, or because of conditions revealed by such application or statement of fact or any report, record, or inspection or other means which would warrant the agency to refuse to grant a registration on an original application, or for violation of, or failure to observe any of the terms and conditions of this rule, or of the registration, or of any rule, or order of the agency.
11.27.c. Except in cases of willfulness or those in which the public health, interest or safety requires otherwise, no registration shall be modified, suspended, or revoked unless, prior to the institution of proceedings therefor, facts or conduct which may warrant such action shall have been called to the attention of the registrant in writing and the registrant shall have been accorded an opportunity to demonstrate or achieve compliance with all lawful requirements.
11.28. Reciprocal Recognition of Registrations
11.28.a. Registrations of Byproduct, Source, and Special Nuclear Material in Quantities Not Sufficient to Form a Critical Mass
11.28.a.1. Subject to this rule, any person who holds a specific registration from the NRC or an agreement state, and issued by the agency having jurisdiction where the registrant maintains an office for directing the registered activity and at which radiation safety records are normally maintained, is hereby granted a general registration to conduct the activities authorized in such registration document within this state for a period not in excess of one hundred eighty (180) days in any calendar year provided that:
11.28.a.1.A. The registration document does not limit the activity authorized by such document to specified installations or locations;
11.28.a.1.B. The out-of-state registrant notifies the agency in writing at least three (3) days prior to engaging in such activity. Such notification shall indicate the location, period, and type of proposed possession and use within the state, and shall be accompanied by a copy of the pertinent registration document. If, for a specific case, the three (3) day period would impose an undue hardship on the out-of-state registrant, the registrant may, upon application to the agency, obtain permission to proceed sooner. The agency may waive the requirement for filing additional written notifications during the remainder of the calendar year following the receipt of the initial notification from a person engaging in activities under the general registration provided in Paragraph 11.28.a.1.;
11.28.a.1.C. The out-of-state registrant complies with all applicable rules of the agency and with all the terms and conditions of the registration document, except any such terms and conditions which may be inconsistent with applicable rules of the agency;
11.28.a.1.D. The out-of-state registrant supplies such other information as the agency may request; and
11.28.a.1.E. The out-of-state registrant shall not transfer or dispose of radioactive material possessed or used under the general registration provided in Paragraph 11.28.a.1. except by transfer to a person:
11.28.a.1.E.1. Specifically registered by the agency or by the NRC to receive such material, or
11.28.a.1.E.2. Exempt from the requirements for a registration for such material under Subdivision 11.3.a.
11.28.a.2. Notwithstanding the provisions of Paragraph 11.28.a.1., any person who holds a specific registration issued by the NRC or an agreement state authorizing the holder to manufacture, transfer, install, or service a device described in Paragraph 11.7.b.1. within areas subject to the jurisdiction of the registration body is hereby granted a general registration to install, transfer, demonstrate, or service such a device in this state provided that:
11.28.a.2.A. Such person shall file a report with the agency within thirty (30) days after the end of each calendar quarter in which any device is transferred to or installed in this state. Each such report shall identify each general registration to whom such device is transferred by name and address, the type of device transferred, and the quantity and type of radioactive material contained in the device;
11.28.a.2.B. The device has been manufactured, labeled, installed, and serviced in accordance with applicable provisions of the specific registration issued to such person by the NRC or an agreement state;
11.28.a.2.C. Such person shall assure that any labels required to be affixed to the device under rules of the authority which registered manufacture of the device bear a statement that "removal of this label is prohibited"; and
11.28.a.2.D. The holder of the specific registration shall furnish to each general registration to whom he transfers such device or on whose premises he installs such device a copy of the general registration contained in Subdivision 11.7.b. in equivalent rules of the agency having jurisdiction over the manufacture and distribution of the device.
11.28.a.3. The agency may withdraw, limit, or qualify its acceptance of any specific registration or equivalent registration document issued by the NRC or an agreement state, or any product distributed pursuant to such registration document, upon determining that such action is necessary in order to prevent undue hazard to public health and safety or property.
11.28.b. Registrations of Naturally Occurring and Accelerator-Produced Radioactive Material
11.28.b.1. Subject to this rule, any person who holds a specific registration from a licensing state, and issued by the agency having jurisdiction where the registrant maintains an office for directing the registered activity and at which radiation safety records are normally maintained, is hereby granted a general registration to conduct the activities authorized in such registration document within this state for a period not in excess of one hundred eighty (180) days in any calendar year provided that:
11.28.b.1.A. The registration document does not limit the activity authorized by such document to specified installations or locations;
11.28.b.1.B. The out-of-state registrant notifies the agency in writing at least three (3) days prior to engaging in such activity. Such notification shall indicate the location, period, and type of proposed possession and use within the state, and shall be accompanied by a copy of the pertinent registration document. If, for a specific case, the three (3) day period would impose an undue hardship on the out-of-state registrant, the registrant may, upon application to the agency, obtain permission to proceed sooner. The agency may waive the requirement for filing additional written notifications during the remainder of the calendar year following the receipt of the initial notification from a person engaging in activities under the general registration provided in Paragraph 11.28.b.1;
11.28.b.1.C. The out-of-state registrant complies with all applicable rules of the agency and with all the terms and conditions of the registration document, except any such terms and conditions which may be inconsistent with applicable rules of the agency;
11.28.b.1.D. The out-of-state registrant supplies such other information as the agency may request; and
11.28.b.1.E. The out-of-state registrant shall not transfer or dispose of radioactive material possessed or used under the general registration provided in 11.28.b.1. except by transfer to a person:
11.28.b.1.E.1. Specifically registered by the agency or by another licensing state to receive such material, or
11.28.b.1.E.2. Exempt from the requirements for a registration for such material under Subsection 11.3.
11.28.b.2. Notwithstanding the provisions of Paragraph 11.28.b.1., any person who holds a specific registration issued by a licensing state authorizing the holder to manufacture, transfer, install, or service a device described in Paragraph 11.7.b.1. within areas subject to the jurisdiction of the registration body is hereby granted a general registration to install, transfer, demonstrate or service such a device in this state provided that:
11.28.b.2.A. Such person shall file a report with the agency within thirty (30) days after the end of each calendar quarter in which any device is transferred to or installed in this state. Each such report shall identify each general registration to whom such device is transferred by name and address, the type of device transferred, and the quantity and type of radioactive material contained in the device;
11.28.b.2.B. The device has been manufactured, labeled, installed, and serviced in accordance with applicable provisions of the specific registration issued to such person by a licensing state;
11.28.b.2.C. Such person shall assure that any labels required to be affixed to the device under rules of the authority which registered manufacture of the device bear a statement that "removal of this label is prohibited"; and
11.28.b.2.D. The holder of the specific registration shall furnish to each general registration to whom he transfers such device or on whose premises he installs such device a copy of the general registration contained in Subdivision 11.7.b. or in equivalent rules of the agency having jurisdiction over the manufacture and distribution of the device.
11.28.b.3. The agency may withdraw, limit, or qualify its acceptance of any specific registration or equivalent registration document issued by a licensing state, or any product distributed pursuant to such registration document, upon determining that such action is necessary in order to prevent undue hazard to public health and safety or property.
W. Va. Code R. § 64-23-12 Use of Radionuclides in the Healing Arts
12.1. Scope. - The provisions of this Section apply to all registrants who use sealed sources in the healing arts and are in addition to, and not in substitution for, other applicable provisions of this rule.
12.2. Definitions. - As used in Section 12. the following definitions apply:
12.2.a. Address of Use - the building or buildings that are identified on the registration and where radioactive material may be produced, prepared, received, used, or stored.
12.2.b. Area of Use - a portion of a physical structure that has been set aside for the purpose of producing, preparing, receiving, using, or storing radioactive material.
12.2.c. Authorized User - a practitioner of the healing arts who is identified as an authorized user on an agency [or the Nuclear Regulatory Commission] registration or registration that authorizes the medical use of radioactive material.
12.2.d. Brachytherapy - a method of radiation therapy in which sealed sources are utilized to deliver a radiation dose at a distance of up to a few centimeters, by surface, intracavitary, or interstitial application.
12.2.e. Dedicated Check Source - a radioactive source that is used to assure the constant operation of a radiation detection or measurement device over several months or years. This source may also be used for other purposes.
12.2.f. Diagnostic Clinical Procedures Manual - a collection of written procedures that describes each method (and other instructions and precautions) by which the registrant performs diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration.
12.2.g. Medical Institution - an organization in which several medical disciplines are practiced.
12.2.h. Medical Use - the intentional internal or external administration of radioactive material, or the radiation therefrom, to humans in the practice of the healing arts.
12.2.i. Misadministration - the administration of:
12.2.i.1. A radiopharmaceutical dosage greater than one and eleven one-hundredths (1.11) megabecquerels (thirty [30] Ci) of either sodium iodide, I-125 or I-131:
12.2.i.1.A. Involving the wrong patient or wrong radiopharmaceutical; or
12.2.i.1.B. When both the administered dosage differs from the prescribed dosage by more than twenty (20) percent of the prescribed dosage and the difference between the administered dosage and prescribed dosage exceeds one and eleven one-hundredths (1.11) megabecquerels (thirty [30] Ci);
12.2.i.2. A therapeutic radiopharmaceutical dosage, other than sodium iodide, I-125 or I-131:
12.2.i.2.A. Involving the wrong patient, wrong radiopharmaceutical, or wrong route of administration; or
12.2.i.2.B. When the administered dosage differs from the prescribed dosage by more than twenty (20) percent of the prescribed dosage;
12.2.i.3. A gamma stereotactic radiosurgery radiation dose:
12.2.i.3.A. Involving the wrong patient or wrong treatment site; or
12.2.i.1.B. When the calculated total administered dose differs from the total prescribed dose by more than ten (10) percent of the total prescribed dose;
12.2.i.4. A teletherapy radiation dose:
12.2.i.4.A. Involving the wrong patient, wrong mode of treatment, or wrong treatment site; or
12.2.i.4.B. When the treatment consists of three (3) or fewer fractions and the calculated total administered dose differs from the total prescribed dose by more than ten (10) percent of the total prescribed dose; or
12.2.i.4.C. When the calculated weekly administered dose exceeds the weekly prescribed dose by thirty (30) percent or more of the weekly prescribed dose; or
12.2.i.4.D. When the calculated total administered dose differs from the total prescribed dose by more than twenty (20) percent of the total prescribed dose;
12.2.i.5. A brachytherapy radiation dose:
12.2.i.5.A. Involving the wrong patient, wrong radionuclide, or wrong treatment site (excluding, for permanent implants, seeds that were implanted in the correct site but migrated outside the treatment site); or
12.2.i.5.B. Involving a sealed source that is leaking; or
12.2.i.5.C. When, for a temporary implant, one or more sealed sources are not removed upon completion of the procedure; or
12.2.i.5.D. When the calculated administered dose differs from the prescribed dose by more than twenty (20) percent of the prescribed dose;
12.2.i.6. A diagnostic radiopharmaceutical dosage, other than quantities greater than one and eleven one-hundredths (1.11) megabecquerels (thirty [30] Ci) of either sodium iodide I-125 or I-131, both:
12.2.i.6.A. Involving the wrong patient, wrong radiopharmaceutical, wrong route of administration, or when the administered dosage differs from the prescribed dosage; and
12.2.i.6.B. When the dose to the patient exceeds fifty (50) millisieverts (five [5] rem) effective dose equivalent or five hundred (500) millisieverts (fifty [50] Rem) dose equivalent to any individual organ.
12.2.j. Mobile Nuclear Medicine Service - the transportation and medical use of radioactive material.
12.2.k. Output - the exposure rate, dose rate, or a quantity related in a known manner to these rates from a teletherapy unit for a specified set of exposure conditions.
12.2.l. Prescribed Dosage - the quantity of radiopharmaceutical activity as documented:
12.2.l.1. In a written directive; or
12.1.l.2. Either in the diagnostic clinical procedures manual or in any appropriate record in accordance with the directions of the authorized user for diagnostic procedures.
12.2.m. Prescribed Dose:
12.2.m.1. For gamma stereotactic radiosurgery, the total dose as documented in the written directive; or
12.2.m.2. For teletherapy, the total dose and dose per fraction as documented in the written directive; or
12.2.m.3. For brachytherapy, either the total source strength and exposure time, or the total dose, as documented in the written directive.
12.2.n. Recordable event - the administration of:
12.2.n.1. A radiopharmaceutical or radiation without a written directive where a written directive is required;
12.2.n.2. A radiopharmaceutical or radiation where a written directive is required without daily recording of each administered radiopharmaceutical dosage or radiation dose in the appropriate record;
12.2.n.3. A radiopharmaceutical dosage greater than one and eleven one-hundredths (1.11) megabecquerels (thirty [30] Ci) of sodium iodide I-125 or I-131 when both the administered dosage differs from the prescribed dosage by more than ten (10) percent of the prescribed dosage, and the difference between the administered dosage and the prescribed dosage exceeds five hundred fifty five (555) kilobecquerels (fifteen [15] Ci);
12.2.n.4. A therapeutic radiopharmaceutical dosage, other than sodium iodide I-125 or I-131, when the administered dosage differs from the prescribed dosage by more than ten (10) percent of the prescribed dosage;
12.2.n.5. A teletherapy radiation dose when the calculated weekly administered dose exceeds the weekly prescribed dose by fifteen (15) percent or more of the weekly prescribed dose; or
12.2.n.6. A brachytherapy radiation dose when the calculated administered dose differs from the prescribed dose by more than ten (10) percent of the prescribed dose.
12.2.o. Teletherapy - therapeutic irradiation in which the source of radiation is at a distance from the body.
12.2.p. Visiting Authorized User - an authorized user who is not identified on the registration of the registrant being visited.
12.2.q. Written Directive - an order in writing for a specific patient, dated and signed by an authorized user prior to the administration of a radiopharmaceutical or radiation, except as specified in 12.2.q.iv., containing the following information:
12.2.q.1. For any administration of quantities greater than one and eleven one-hundredths (1.11) megabecquerels (thirty [30] Ci) of sodium iodide I-125 or I-131: the radionuclide, and dosage; or
12.2.q.2. For a therapeutic administration of a radiopharmaceutical other than sodium iodide I-125 or I-131: the radiopharmaceutical, dosage, and route of administration; or
12.2.q.3. For gamma stereotactic radiosurgery: target coordinates, collimator size, plug pattern, and total dose; or
12.2.q.4. For teletherapy: the total dose, dose per fraction, treatment site, and overall treatment period; or
12.2.q.5. For high-dose-rate remote afterloading brachytherapy: the radionuclide, treatment site, and total dose; or
12.2.q.6. For all other brachytherapy,
12.2.q.6.A. Prior to implantation: the radionuclide, number of sources, and source strengths; and
12.2.q.6.B. After implantation but prior to completion of the procedure: the radionuclide, treatment site, and total source strength and exposure time (or, equivalently, the total dose).
12.3. Registration Required.
12.3.a. No person shall manufacture, produce, prepare, compound, acquire, receive, possess, use, or transfer radioactive material for medical use except in accordance with a registration issued pursuant to this rule.
12.3.b. Unless prohibited by registration condition, an individual may receive, possess, use, or transfer radioactive material in accordance with the rules in Section 11 under the supervision of an authorized user as provided in Subsection 11.10.
12.4. Registration Amendments. A registrant shall apply for and receive a registration amendment:
12.4.a. Before using radioactive material for a method or type of medical use not permitted by the registration issued under Section 11;
12.4.b. Before permitting anyone, except a visiting authorized user described in Section 11.11, to work as an authorized user under the registration;
12.4.c. Before changing a radiation safety officer or teletherapy physicist;
12.4.d. Before receiving radioactive material in excess of the amount authorized on the registration;
12.4.e. Before adding to or changing the areas of use or address or addresses of use identified in the application or on the registration; and
12.4.f. Before changing statements, representations, and procedures which are incorporated into the registration.
12.5. Notifications. A registrant shall notify the agency in writing within 30 days when an authorized user, radiation safety officer, or teletherapy physicist, permanently discontinues performance of duties under the registration.
12.6. ALARA Program
12.6.a. Each registrant shall develop and implement a written program to maintain radiation doses and releases of radioactive material in effluents to unrestricted areas as low as reasonably achievable (ALARA) as defined in Section 1. of this rule.
12.6.b. To satisfy the requirement of Subdivision 11.6.a.:
12.6.b.1. The management, radiation safety officer, and all authorized users shall participate in the establishment, implementation, and operation of the program as required by this rule or the radiation safety committee; or
12.6.b.2. For registrants that are not medical institutions, management and all authorized users shall participate in the program as required by the radiation safety officer.
12.6.c. The ALARA program shall include an annual review by the radiation safety committee for registrant s that are medical institutions, or management and the radiation safety officer for registrants that are not medical institutions, of summaries of the types and amounts of radioactive material used, occupational dose reports, and continuing education and training for all personnel who work with or in the vicinity of radioactive material. The purpose of the review is to ensure that individuals make every reasonable effort to maintain occupational doses, doses to the general public, and releases of radioactive material as low as reasonably achievable, taking into account the state of technology, and the cost of improvements in relation to benefits.
12.6.d. The registrant shall retain a current written description of the ALARA program for the duration of the registration. The written description shall include:
12.6.d.1. A commitment by management to keep occupational doses as low as reasonably achievable;
12.6.d.2. A requirement that the radiation safety officer brief management once each year on the radiation safety program;
12.6.d.3. Personnel exposure investigational levels as established in accordance with Paragraph 11.8.b.8. that, when exceeded, will initiate an investigation by the radiation safety officer of the cause of the exposure; and
12.6.d.4. Personnel exposure action levels that, when exceeded, will initiate a prompt investigation by the radiation safety officer of the cause of the exposure and a consideration of actions that might be taken to reduce the probability of recurrence.
12.7. Radiation Safety Officer.
12.7.a. A registrant shall appoint a radiation safety officer responsible for implementing the radiation safety program. The registrant, through the radiation safety officer, shall ensure that radiation safety activities are being performed in accordance with approved procedures and regulatory requirements in the daily operation of the registrant’s radioactive material program.
12.7.b. The Radiation Safety Officer shall:
12.7.b.1. Investigate overexposures, misadministrations, accidents, spills, losses, thefts, unauthorized receipts, uses, transfers, and disposals, and other deviations from approved radiation safety practice and implement corrective actions as necessary;
12.7.b.2. Implement written policy and procedures for:
12.7.b.2.A. Authorizing the purchase of radioactive material;
12.7.b.2.B. Receiving and opening packages of radioactive material;
12.7.b.2.C. Storing radioactive material;
12.7.b.2.D. Keeping an inventory record of radioactive material;
12.7.b.2.E. Using radioactive material safely;
12.7.b.2.F. Taking emergency action if control of radioactive material is lost;
12.7.b.2.G. Performing periodic radiation surveys;
12.7.b.2.H. Performing checks and calibrations of survey instruments and other safety equipment;
12.7.b.2.I. Disposing of radioactive material;
12.7.b.2.J. Training personnel who work in or frequent areas where radioactive material is used or stored; and
12.7.b.2.K. Keeping a copy of all records and reports required by the agency rules, a copy of this rule, a copy of each registration request and registration and amendments and the written policy and procedures required by the rules; and
12.7.c. For medical use not sited at a medical institution, approve or disapprove radiation safety program changes with the advice and consent of management prior to submittal to the agency for registration action; or
12.7.d. For medical use sited at a medical institution, assist the radiation safety committee in the performance of its duties.
12.8. Radiation Safety Committee. Each medical institution registrant shall establish a radiation safety committee to oversee the use of radioactive material.
12.8.a. The committee shall meet the following administrative requirements:
12.8.a.1. Membership must consist of at least three (3) individuals and shall include an authorized user of each type of use permitted by the registration, the radiation safety officer, a representative of the nursing service, and a representative of management who is neither an authorized user nor a radiation safety officer. Other members may be included as the registrant deems appropriate;
12.8.a.2. The committee shall meet at least once each calendar quarter;
12.8.a.3. To establish a quorum and to conduct business, one-half of the committee's membership shall be present, including the radiation safety officer and the management's representative;
12.8.a.4. The minutes of each radiation safety committee meeting shall include:
12.8.a.4.A. The date of the meeting;
12.8.a.4.B. Members present;
12.8.a.4.C. Members absent;
12.8.a.4.D. Summary of deliberations and discussions;
12.8.a.4.E. Recommended actions and the numerical results of all ballots;
12.8.a.4.F. Documentation of any reviews required in Subdivision 11.6.c. and 11.8.b.;
12.8.a.4.G. The committee shall provide each member with a copy of the meeting minutes, and retain one copy until the agency authorizes its disposition.
12.8.b. To oversee the use of registered material, the committee shall:
12.8.b.1. Be responsible for monitoring the institutional program to maintain occupational doses as low as reasonably achievable;
12.8.b.2. Review, on the basis of safety and with regard to the training and experience standards of Section 11, and approve or disapprove any individual who is to be listed as an authorized user, the radiation safety officer, or teletherapy physicist before submitting a registration application or request for amendment or renewal;
12.8.b.3. Review on the basis of safety and approve or disapprove each proposed method of use of radioactive material;
12.8.b.4. Review on the basis of safety, and approve with the advice and consent of the radiation safety officer and the management representative, or disapprove procedures and radiation safety program changes prior to submittal to the agency for registration action;
12.8.b.5. Review quarterly, with the assistance of the radiation safety officer, occupational radiation exposure records of all personnel working with radioactive material;
12.8.b.6. Review quarterly, with the assistance of the radiation safety officer, all incidents involving radioactive material with respect to cause and subsequent actions taken;
12.8.b.7. Review annually, with the assistance of the radiation safety officer, the radioactive material program; and
12.8.b.8. Establish a Table of investigational and action levels for occupational dose that, when exceeded, will initiate investigations and considerations of action by the radiation safety officer.
12.9. Statement of Authorities and Responsibilities.
12.9.a. A registrant shall provide sufficient authority and organizational freedom to the radiation safety officer and the radiation safety committee to:
12.9.a.1. Identify radiation safety problems;
12.9.a.2. Initiate, recommend, or provide solutions; and
12.9.a.3. Verify implementation of corrective actions.
12.9.b. A registrant shall establish in writing the authorities, duties, responsibilities, and radiation safety activities of the radiation safety officer and the radiation safety committee.
12.10. Supervision.
12.10.a. A registrant who permits the receipt, possession, production, preparation, compounding, use, or transfer of radioactive material by an individual under the supervision of an authorized user as allowed by Subsection 11.3. shall:
12.10.a.1. Instruct the supervised individual in the principles of radiation safety appropriate to that individual's use of radioactive material and in the registrant 's written quality management program;
12.10.a.2. Periodically review the supervised individual's use of radioactive material, the records kept to reflect this use, and provide reinstruction as needed;
12.10.a.3. Require an authorized user to be immediately available to communicate with the supervised individual; and
12.10.a.4. Require that only those individuals permitted under state and local rules and specifically trained, and designated by the authorized user, be permitted to administer radionuclides or radiation to patients.
12.10.b. A registrant shall require the supervised individual receiving, possessing, producing, preparing, compounding, using or transferring radioactive material under Subsection 11.3. to:
12.10.b.1. Follow the instructions of the supervising authorized user;
12.10.b.2. Follow the written radiation safety and quality management procedures established by the registrant; and
12.10.b.3. Comply with this rule conditions with respect to the use of radioactive material.
12.11. Visiting Authorized User.
12.11.a. A registrant may permit any visiting authorized user to use registered material for medical use under the terms of the registrant’s registration for sixty (60) days each year if:
12.11.a.1. The visiting authorized user has the prior written permission of the registrant’s management and, if the use occurs on behalf of an institution, the institution's radiation safety committee;
12.11.a.2. The registrant has a copy of an agency, agreement state, licensing state or the Nuclear Regulatory Commission registration that identifies the visiting authorized user by name as an authorized user for medical use; and
12.11.a.3. Only those procedures for which the visiting authorized user is specifically authorized by an agency, agreement state, licensing state or the Nuclear Regulatory Commission registration are performed by that individual.
12.11.b. A registrant need not apply for a registration amendment in order to permit a visiting authorized user to use registered material as described in Subdivision 11.11.a.
12.11.c. A registrant shall retain copies of the records specified in Subdivision 11.11.a. for 3 years from the date of the last visit.
12.12. Mobile Nuclear Medicine Service Administrative Requirements.
12.12.a. The agency shall register mobile nuclear medicine services or clients of such services. The mobile nuclear medicine service shall be registered if the service receives, uses or possesses radioactive material. The client of the mobile nuclear medicine service shall be registered if the client receives or possesses radioactive material to be used by a mobile nuclear medicine service.
12.12.b. Mobile nuclear medicine service registrations shall retain for the duration of service a letter signed by the management of each location where services are rendered that authorizes use of radioactive material. If the client is registered, the letter shall document procedures for notification, receipt, storage and documentation of transfer of radioactive material delivered to the client's location for use by the mobile nuclear medicine service.
12.12.c. A mobile nuclear medicine service shall not have radioactive material delivered directly from the manufacturer or the distributor to the client's address of use, unless the client has a registration. Radioactive material delivered to the client's address of use shall be received and handled in conformance with the client's registration.
12.12.d. A mobile nuclear medicine service shall inform a responsible individual, such as a representative of management in charge of the patient or the registered nurse in charge of the nursing unit, who is on site at each client's address of use at the time that radiopharmaceuticals are being administered.
12.13. Quality Management Program.
12.13.a. Each registrant shall establish and maintain a written quality management program to provide assurance that radioactive material or radiation therefrom will be administered as directed by the authorized user. The quality management program shall include written policies and procedures to meet the following specific objectives:
12.13.a.1. That, prior to administration, a written directive is prepared for:
12.13.a.1.A. Any teletherapy radiation dose;
12.13.a.1.B. Any gamma stereotactic radiosurgery radiation dose;
12.13.a.1.C. Any brachytherapy radiation dose;
12.13.a.1.D. Any administration of quantities greater than one and eleven one-hundredths (1.11) megabecquerels (thirty [30] Ci) of either sodium iodide I-125 or I-131; or
12.13.a.1.E. Any therapeutic administration of a radiopharmaceutical, other than sodium iodide I-125 or I-131;
(NOTE: If, because of the patient's condition, a delay in order to provide a written revision to an existing written directive would jeopardize the patient's health, an oral revision to an existing written directive will be acceptable, provided that the oral revision is documented immediately in the patient's record and a revised written directive is signed by the authorized user within forty eight (48) hours of the oral revision. Also, a written revision to an existing written directive may be made for any diagnostic or therapeutic procedure provided that the revision is dated and signed by an authorized user prior to the administration of the radiopharmaceutical dosage, the brachytherapy dose, the gamma stereotactic radiosurgery dose, the teletherapy dose, or the next teletherapy fractional dose. If, because of the emergent nature of the patient's condition, a delay in order to provide a written directive would jeopardize the patient's health, an oral directive will be acceptable, provided that the information contained in the oral directive is documented immediately in the patient's record and a written directive is prepared within twenty four (24) hours of the oral directive.)
12.13.a.2. That, prior to each administration, the patient's identity is verified by more than one method as the individual named in the written directive;
12.13.a.3. That final plans of treatment and related calculations for brachytherapy, teletherapy, and gamma stereotactic radiosurgery are in accordance with the respective written directives;
12.13.a.4. That each administration is in accordance with the written directive; and
12.13.a.5. That any unintended deviation from the written directive is identified and evaluated, and appropriate action is taken.
12.13.b. Each registrant shall:
12.13.b.1. Develop procedures for and conduct a review of the quality management program including, since the last review, an evaluation of a representative sample of patient administrations, all recordable events, and all misadministrations to verify compliance with all aspects of the quality management program; these reviews shall be conducted at intervals no greater than twelve (12) months;
12.13.b.2. Evaluate each of these reviews to determine the effectiveness of the quality management program and, if required, make modifications to meet the objectives of Subdivision 11.13.a.; and
12.13.b.3. Retain records of each review, including the evaluations and findings of the review, in an auditable form for three (3) years.
12.13.c. The registrant shall evaluate and respond to each recordable event, within thirty (30) days after discovery of the recordable event, by:
12.13.c.1. Assembling the relevant facts including the cause;
12.13.c.2. Identifying what, if any, corrective action is required to prevent recurrence; and
12.13.c.3. Retaining a record, in an auditable form, for 3 years, of the relevant facts and what corrective action, if any, was taken.
12.13.d. Each registrant shall retain:
12.13.d.1. Each written directive; and
12.13.d.2. A record of each administered radiation dose or radiopharmaceutical dosage where a written directive is required in Paragraph 11.13.a.1., in an auditable form, for three (3) years after the date of administration.
12.13.e. The registrant may make modifications to the quality management program to increase the program's efficiency provided the program's effectiveness is not decreased.
12.14. Records, Notifications, and Reports of Misadministrations.
12.14.a. For a misadministration:
12.14.a.1. The registrant shall notify the agency by telephone no later than twenty four (24) hours after discovery of the misadministration;
12.14.a.2. The registrant shall submit a written report to the agency within fifteen (15) days after discovery of the misadministration. The written report must include the registrant’s name; the prescribing physicians's name; a brief description of the event; why the event occurred; the effect on the patient; what improvements are needed to prevent recurrence; actions taken to prevent recurrence; whether the registrant notified the patient, or the patient's responsible relative or guardian (this person will be subsequently referred to as "the patient"), and if not, why not, and if the patient was notified, what information was provided to the patient. The report must not include the patient's name or other information that could lead to identification of the patient;
12.14.a.3. The registrant shall notify the referring physician and also notify the patient of the misadministration not later than 24 hours after its discovery, unless the referring physician personally informs the registrant either that he or she will inform the patient or that, based on medical judgement, telling the patient would be harmful. The registrant is not required to notify the patient without first consulting the referring physician. If the referring physician or patient cannot be reached within twenty four (24) hours, the registrant shall notify the patient as soon as possible thereafter. The registrant may not delay any appropriate medical care for the patient, including any necessary remedial care as a result of the misadministration, because of any delay in notification;
12.14.a.4. If the patient was notified, the registrant shall also furnish, within fifteen (15) days after discovery of the misadministration, a written report to the patient by sending either:
12.14.a.4.A. A copy of the report that was submitted to the agency; or
12.14.a.4.B. A brief description of both the event and the consequences, as they may affect the patient, provided a statement is included that the report submitted to the agency can be obtained from the registrant.
12.14.b. Each registrant shall retain a record of each misadministration for five (5) years. The record shall contain the names of all individuals involved (including the prescribing physician, allied health personnel, the patient, and the patient's referring physician), the patient's social security number or identification number if one has been assigned, a brief description of the misadministration, why it occurred, the effect on the patient, what improvements are needed to prevent recurrence, and the actions taken to prevent recurrence.
12.14.c. Aside from the notification requirement, nothing in Subdivisions 11.14.a. and 11.14.b. shall affect any rights or duties of registrant s and physicians in relation to each other, patients, or the patient's responsible relatives or guardians.
12.15. Suppliers. A registrant shall use for medical use only:
12.15.a. Radioactive material manufactured, produced, labeled, prepared, compounded, packaged, and distributed in accordance with a registration issued pursuant to this rule or the equivalent rules of an agreement state, a licensing state or the Nuclear Regulatory Commission; and
12.15.b. Reagent kits, radiopharmaceuticals, or radiobiologics that have been manufactured, labeled, packaged, and distributed in accordance with an approval issued by the food and drug administration; or
12.15.c. Radiopharmaceuticals compounded from a prescription in accordance with the rules of the State Board of Pharmacy.
12.15.d. Teletherapy and brachytherapy sources manufactured and distributed in accordance with a registration issued pursuant to this rule, or the equivalent rules of an agreement state, a licensing state, or the Nuclear Regulatory Commission.
12.16. Quality Control of Diagnostic Equipment. Each registrant shall establish written quality control procedures for all diagnostic equipment used for radionuclide studies. As a minimum, quality control procedures and frequencies shall be those recommended by equipment manufacturers or procedures which have been approved by the agency. The registrant shall conduct quality control procedures in accordance with written procedures.
12.17. Possession, Use, Calibration, and Check of Dose Calibrators.
12.17.a. A medical use registrant authorized to administer radiopharmaceuticals shall possess a dose calibrator and use it to measure the amount of activity administered to each patient. In the case where the ionization type dose calibrator cannot be used effectively to verify administered activity, the registrant shall use an alternative method. Any alternative method to the use of a dose calibrator shall be approved by the agency in writing. Any alternative method shall provide for acceptable verification of constancy, accuracy, linearity, and geometry dependence as applicable.
12.17.b. Each registrant shall establish written quality control procedures for all dose calibrators used for measuring the amount of activity administered to a patient. As a minimum, quality control procedures and frequencies shall be those recommended by the American National Standards Institute in ANSI N42.13-1986 or the registrant shall:
12.17.b.1. Check each dose calibrator for constancy with a dedicated check source at the beginning of each day of use. The check shall be done on a frequently used setting with a sealed source of not less than one and eighty vive one-hundredths (1.85) megabecquerels (fifty [50] Ci) of any photon-emitting radionuclide with a half-life greater than 90 days;
12.17.b.2. Test each dose calibrator for accuracy upon installation and at intervals not to exceed 12 months thereafter by assaying at least two (2) sealed sources containing different radionuclides with activities of at least one and eighty five one-hundredths (1.85) megabecquerels (fifty [50] Ci) each. The activity of one source shall be determined by the manufacturer to be within five (5) percent of the stated activity. All other sources used for this test shall be within ten (10) percent of the stated activity. All sources used to satisfy the accuracy test shall be calibration sources traceable to the national institute of standards and technology or other standards recognized as being equivalent by the national institute of standards and technology;
12.17.b.3. Test each dose calibrator for linearity upon installation and at intervals not to exceed three (3) months thereafter over the range of use between three hundred seventy (370) kilobecquerels (ten [10] Ci) and the highest dosage that will be assayed; and
12.17.b.4. Test each dose calibrator for geometry dependence upon installation over the range of volumes and volume configurations for which it will be used. The registrant shall keep a record of this test for the duration of the use of the dose calibrator.
12.17.c. A registrant shall mathematically correct dosage readings for any geometry or linearity error that exceeds ten (10) percent if the dosage is greater than three hundred seventy (370) kilobecquerels (ten [10] Ci) and shall repair or replace the dose calibrator if the accuracy or constancy error exceeds ten (10) percent.
12.17.d. A registrant shall also perform checks and tests required by Subdivision 11.17.b. following adjustment or repair of the dose calibrator.
12.17.e. A registrant shall retain a record of each check and test required by Subsection 11.17. or three (3) years. The records required by Subdivision 11.17.b. shall include:
12.17.e.1. For Paragraph 11.17.b.1., the model and serial number of the dose calibrator, the identity and calibrated activity of the radionuclide contained in the check source, the date of the check, the activity measured, the instrument settings, and the initials of the individual who performed the check;
12.17.e.2. For Paragraph 11.17.b.2., the model and serial number of the dose calibrator, the model and serial number of each source used and the identity of the radionuclide contained in the source and its activity, the date of the test, the results of the test, the instrument settings, and the signature of the individual who performed the test;
12.17.e.3. For Paragraph 11.17.b.3., the model and serial number of the dose calibrator, the calculated activities, the measured activities, the date of the test, and the signature of the individual who performed the test; and
12.17.e.4. For Paragraph 11.17.b.4., the model and serial number of the dose calibrator, the configuration and calibrated activity of the source measured, the activity of the source, the activity measured and the instrument setting for each volume measured, the date of the test, and the signature of the individual who performed the test.
12.18. Calibration and Check of Survey Instruments.
12.18.a. A registrant shall ensure that the survey instruments used to show compliance with Section 12. have been calibrated before first use, annually, and following repair.
12.18.b. To satisfy the requirements of Subdivision 11.18.a. registrant shall:
12.18.b.1. Calibrate all required scale readings up to ten (10) millisieverts (one thousand [1000] mRem) per hour with a radiation source;
12.18.b.2. For each scale that shall be calibrated, calibrate two (2) readings separated by at least fifty (50) percent of scale rating; and
12.18.b.3. Conspicuously note on the instrument the apparent dose rate from a dedicated check source as determined at the time of calibration, and the date of calibration.
12.18.c. To satisfy the requirements of Subdivision 11.18.b., the registrant shall consider a point as calibrated if the indicated exposure rate differs from the calculated exposure rate by not more than ten (10) percent; and consider a point as calibrated if the indicated exposure rate differs from the calculated exposure rate by not more than twenty (20) percent if a correction chart or graph is conspicuously attached to the instrument.
12.18.d. A registrant shall check each survey instrument for proper operation with the dedicated check source before each use. The registrant is not required to keep records of these checks.
12.18.e. The registrant shall retain a record of each calibration required in Subdivision 11.18.a. for three (3) years. The record shall include:
12.18.e.1. A description of the calibration procedure; and
12.18.e.2. A description of the source used and the certified dose rates from the source, and the rates indicated by the instrument being calibrated, the correction factors deduced from the calibration data, the signature of the individual who performed the calibration, and the date of calibration.
12.18.f. To meet the requirements of Subdivisions 11.18.a., b., and c., the registrant may obtain the services of individuals registered by the agency, the Nuclear Regulatory Commission, an agreement state, or a licensing state to perform calibrations of survey instruments. Records of calibrations which contain information required by Subdivision 11.18.e. shall be maintained by the registrant.
12.19. Assay of Radiopharmaceutical Dosages. A registrant shall:
12.19.a. Assay, [within 30 minutes] before medical use, the activity of each radiopharmaceutical dosage that contains more than three hundred seventy (370) kilobecquerels (ten [10] Ci) of a photon-emitting radionuclide;
12.19.b. Assay, before medical use, the activity of each radiopharmaceutical dosage emitting alpha and beta radiation or alpha or beta radiation as the radiation of principal interest, unless such radiopharmaceutical has been obtained:
12.19.b.1. In unit dose form, calibrated by the supplier for individual patients; and
12.19.b.2. From a supplier which participates in a measurement quality assurance program with the national institute of standards and technology, and which is designed to ensure that unit doses have a calibration traceable to a national standard;
12.19.c. Retain a record of the assays or calibrations required by Subdivision 11.19.a. and b., for three (3) years. To satisfy this requirement, the record shall contain the:
12.19.c.1. Radiopharmaceutical, or the radionuclide administered;
12.19.c.2. Patient's name, and identification number if one has been assigned;
12.19.c.3. Prescribed dosage and measured activity of the dosage at the time of assay, or a notation that the total activity was determined by a calibration traceable to a national standard;
12.19.c.4. Date and time of the assay or calibration and the date and time of the administration; and
12.19.c.5. Initials of the individual who performed the assay or documentation of the supplier's participation in the measurement quality assurance program specified in Subdivision 11.18.b.
12.20. Authorization for Calibration and Reference Sources. Any person authorized by Subsection 11.3. for medical use of radioactive material may receive, possess, and use the following radioactive material for check, calibration and reference use:
12.20.a. Sealed sources manufactured and distributed by persons specifically registered pursuant to Section 11. of this rule or equivalent provisions of the Nuclear Regulatory Commission, agreement state or licensing state and that do not exceed five hundred fifty five (555) megabecquerels (fifteen [15] mCi) each;
12.20.b. Any radioactive material [listed in Subsections 12.31. or 11.33.] with a half-life of one hundred (100) days or less in individual amounts not to exceed five hundred fifty five (555) megabecquerels (fifteen [15] mCi);
12.20.c. Any radioactive material [listed in Subsections 12.31. or 12.33.] with a half-life greater than one hundred (100) days in individual amounts not to exceed seven and four-tenths (7.4) megabecquerels (two hundred [200] Ci) each; and
12.20.d. Technetium-99m in individual amounts not to exceed one and eighty five one-hundredths (1.85) gigabecquerels (fifty [50] mCi).
12.21. Requirements for Possession of Sealed Sources and Brachytherapy Sources.
12.21.a. A registrant in possession of any sealed source or brachytherapy source shall follow the radiation safety and handling instructions supplied by the manufacturer or equivalent instructions approved by the agency and shall maintain the instructions for the duration of source use in a legible form convenient to users.
12.21.b. A registrant in possession of a sealed source shall assure that:
12.21.b.1. The source is tested for leakage before its first use unless the registrant has a certificate from the supplier indicating that the source was tested within six (6) months before transfer to the registrant; and
12.21.b.2. The source is tested for leakage at intervals not to exceed six (6) months or at intervals approved by the agency, another agreement state, a licensing state or the Nuclear Regulatory Commission.
12.21.c. To satisfy the leak test requirements of Subdivision 12.21.b., the registrant shall assure that:
12.21.c.1. Leak tests are capable of detecting the presence of one hundred eighty five (185) becquerels (five one-thousandths [0.005] Ci) of radioactive material on the test sample, or in the case of radium, the escape of radon at the rate of thirty seven (37) becquerels (one one-thousandth [0.001] Ci) per twenty four (24) hours;
12.21.c.2. Test samples are taken from the source or from the surfaces of the device in which the source is mounted or stored on which radioactive contamination might be expected to accumulate; and
12.21.c.3. Test samples are taken when the device containing the source is in the "off" position.
12.21.d. A registrant shall retain leak test records for 5 years. The records shall contain the model number, and serial number, if assigned, of each source tested, the identity of each source radionuclide and its estimated activity, the measured activity of each test sample expressed in becquerels (Ci), a description of the method used to measure each test sample, the date of the test, and the signature of the individual who performed the test.
12.21.e. If the leak test reveals the presence of one hundred eighty five (185) becquerels (five one-thousandths [0.005] Ci) or more of removable contamination, the registrant shall:
12.21.e.1. Immediately withdraw the sealed source from use and store, repair or dispose of it in accordance with the requirements of Section d of this rule; and
12.21.e.2. File a report with the agency within five (5) days of receiving the leak test results with the agency describing the equipment involved, the test results, and the action taken.
12.21.f. A registrant need not perform a leak test on the following sources:
12.21.f.1. Sources containing only radioactive material with a half-life of less than thirty (30) days;
12.21.f.2. Sources containing only radioactive material as a gas; and
12.21.f.3. Sources containing three and seven-tenths (3.7) megabecquerels (one hundred [100] Ci) or less of beta- or photon-emitting material or three hundred seventy (370) kilobecquerels (ten [10] Ci) or less of alpha-emitting material.
12.21.g. A registrant in possession of a sealed source or brachytherapy source shall conduct a physical inventory of all such sources at intervals not to exceed 3 months. The registrant shall retain each inventory record for five (5) years. The inventory records shall contain the model number of each source, and serial number if one has been assigned, the identity of each source radionuclide and its estimated activity, the location of each source, date of the inventory, and the signature of the individual who performed the inventory.
12.21.h. A registrant in possession of a sealed source or brachytherapy source shall survey with a radiation survey instrument at intervals not to exceed 3 months all areas where such sources are stored. This does not apply to teletherapy sources in teletherapy units or sealed sources in diagnostic devices.
12.21.i. A registrant shall retain a record of each survey required in Subdivision 12.21.h. for 3 years. The record shall include the date of the survey, a sketch of each area that was surveyed, the measured dose rate at several points in each area expressed in microsieverts (mRem) per hour, the model number and serial number of the survey instrument used to make the survey, and the signature of the individual who performed the survey.
12.22. Syringe Shields.
12.22.a. A registrant shall keep syringes that contain radioactive material to be administered in an appropriate radiation shield or shielded area.
12.22.b. A registrant shall require each individual who prepares or administers radiopharmaceuticals to use an appropriate syringe radiation shield unless the use of the shield is contraindicated for that patient.
12.23. Syringe Labels. Unless utilized immediately, a registrant shall conspicuously identify each syringe, or syringe radiation shield as to contents or intended patient.
12.24. Vial Shields. A registrant shall require each individual preparing or handling a vial that contains a radiopharmaceutical to keep the vial in a vial radiation shield.
12.25. Vial Shield Labels. A registrant shall conspicuously label each vial radiation shield that contains a vial of a radiopharmaceutical with the radiopharmaceutical name or its abbreviation.
12.26. Surveys for Ambient Radiation Dose Rate and Contamination.
12.26.a. A registrant shall survey with a radiation detection survey instrument at the end of each day of use all areas where radiopharmaceuticals are prepared for use or administered.
12.26.b. A registrant shall survey with a radiation detection survey instrument at least once each week all areas where radiopharmaceuticals or radioactive wastes are stored.
12.26.c. A registrant shall conduct the surveys required by Subdivision 12.26.a. and b. so as to able to measure dose rates as low as one (1) microsievert (one-tenth [0.1] mRem) per hour.
12.26.d. A registrant shall establish dose rate action levels for the surveys required by Subdivision 12.26.a. and b. and shall require that the individual performing the survey immediately notify the radiation safety officer if a dose rate exceeds an action level.
12.26.e. A registrant shall survey for removable contamination each day of use all areas where radiopharmaceuticals are prepared for use or administered and each week where radioactive materials are stored.
12.26.f. A registrant shall conduct the surveys required by Subdivision 12.26.e. so as to be able to detect contamination on each wipe sample of thirty three and three-tenths (33.3) becquerels (two thousand [2000] dpm).
12.26.g. A registrant shall establish removable contamination action levels for the surveys required by Subdivision 12.26.e. and shall require that the individual performing the survey immediately notify the radiation safety officer if contamination exceeds action levels.
12.26.h. A registrant shall retain a record of each survey required by Subdivision 12.26.a., b., and e. for three (3) years. The record must include the date of the survey, a sketch of each area surveyed, action levels established for each area, the measured dose rate at several points in each area expressed in microsieverts (mRem) per hour or the removable contamination in each area expressed in becquerels (dpm) per one hundred (100) square centimeters, the serial number and the model number of the instrument used to make the survey or analyze the samples, and the initials of the individual who performed the survey.
12.27. Release of Patients Containing Radiopharmaceuticals or Permanent Implants.
12.27.a. A registrant shall not authorize release from confinement for medical care any patient administered a radiopharmaceutical until either:
12.27.a.1. The dose rate from the patient is less than fifty (50) Sv (five [5] millirems) per hour at a distance of one (1) meter; or
12.27.a.2. The activity in the patient is less than one and eleven one-hundredths (1.11) GBq (thirty [30] millicuries).
12.27.b. A registrant shall not authorize release from confinement for medical care any patient administered a permanent implant until the dose rate from the patient is less than fifty (50) Sv (five [5] millirems) per hour at a distance of one (1) meter.
12.28. Mobile Nuclear Medicine Service Technical Requirements. A registrant providing mobile nuclear medicine service shall:
12.28.a. Transport to each address of use only syringes or vials containing prepared radiopharmaceuticals or radiopharmaceuticals that are intended for reconstitution of radiopharmaceutical kits;
12.28.b. Bring into each area of use all radioactive material to be used and, before leaving, remove all unused radioactive material and associated radioactive waste;
12.28.c. Secure or keep under constant surveillance and immediate control all radioactive material when in transit or at an area of use;
12.28.d. In addition to complying with Subsection 12.17. and 12.18., check survey instruments and dose calibrators for constancy and response, and check all other transported equipment for proper function before medical use at each area of use;
12.28.e. Carry a survey meter calibrated in accordance with Subsection 12.18. in each vehicle that is being used to transport radioactive material, and, before leaving a client area of use, survey all areas of radiopharmaceutical use with a radiation detection survey instrument, including a survey for removable contamination, to ensure that all radiopharmaceuticals and all associated radioactive waste have been removed;
12.28.f. Retain a record of each survey required by Subdivision 12.28.e. for 3 years. The record must include the date of the survey, a plan of each area that was surveyed, the measured dose rate at several points in each area of use expressed in microsieverts (mRem) per hour, the removable contamination in each area expressed in becquerels (dpm) per one hundred (100) square centimeters, the model and serial number of the instrument used to make the survey, and the initials of the individual who performed the survey; and
12.28.g. Use radioactive gases only in areas of use and under conditions which have been evaluated and approved by the agency for compliance with airborne release standards.
12.29. Storage of Volatiles and Gases.
12.29.a. A registrant shall store volatile radiopharmaceuticals and radioactive gases in the shippers' radiation shield and container.
12.29.b. A registrant shall store and use a multidose container in a properly functioning fume hood.
12.30. Decay-In-Storage.
12.30.a. Before disposal in ordinary trash, a registrant shall hold radioactive material for decay-in-storage and is exempt from the waste disposal requirements of section 6. of this rule if the registrant:
12.30.a.1. Holds radioactive material for decay a minimum of ten (10) half-lives;
12.30.a.2. Monitors radioactive material at the container surface before disposal as ordinary trash and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey instrument set on its most sensitive scale and with no interposed shielding;
12.30.a.3. Removes or obliterates all radiation labels; and
12.30.a.4. Separates and monitors each generator column individually with all radiation shielding removed to ensure that its contents have decayed to background radiation level before disposal.
12.30.b. For radioactive material disposed in accordance with Subdivision 12.30.a., the registrant shall retain a record of each disposal for three (3) years. The record must include the date of the disposal, the date on which the radioactive material was placed in storage, the radionuclides disposed, the model and serial number of the survey instrument used, the background dose rate, the radiation dose rate measured at the surface of each waste container, and the name of the individual who performed the disposal.
12.31. Use of Radiopharmaceuticals for Uptake, Dilution, or Excretion Studies.
12.31.a. A registrant may use any radioactive material in a radiopharmaceutical for a diagnostic use involving measurements of uptake, dilution, or excretion:
12.31.a.1. Which has been granted acceptance or approval by the Food and Drug Administration; or
12.31.a.2. Which is prepared and compounded in accordance with the rules of the State Board of Pharmacy.
12.32. Possession of Survey Instrument. A registrant authorized to use radioactive material for uptake, dilution, and excretion studies shall possess a portable radiation detection survey instrument capable of detecting dose rates over the range one (1) microsievert (one-tenth [0.1] mRem) per hour to five hundred (500) microsieverts (fifty [50] mRems) per hour. The instrument shall be operable and calibrated in accordance with Subsection 12.18.
12.33. Use of Radiopharmaceuticals, Generators, and Reagent Kits for Imaging and Localization Studies. A registrant may use any radioactive material in a diagnostic radiopharmaceutical (except aerosol or gaseous forms) or any generator or reagent kit for preparation and diagnostic use of a radiopharmaceutical containing radioactive material:
12.33.a. Which has been granted acceptance or approval by the Food and Drug Administration; or
12.33.b. Which has been prepared and compounded in accordance with the rules of the State Board of harmacy;
12.33.c. A registrant shall elute generators in compliance with Subsection 12.34.;
12.33.d. Provided the conditions of Subsection 12.35. are met, a registrant shall use radioactive aerosols or gases only if specific application is made to and approved by the agency.
12.34. Radionuclide Contaminants.
12.34.a. A registrant shall not administer a radiopharmaceutical containing:
12.34.a.1. More than fifteen one-hundredths (0.15) kilobecquerel of Molybdenum-99 per megabecquerel of Technetium-99m (fifteen one-hundredths [0.15] Ci of Mo-99 per mCi of Tc-99m);
12.34.a.2. More than two one-hundredths (0.02) kilobecquerel of Strontium-82 per megabecquerel of Rubidium-82 chloride injection (two one-hundredths (0.02) Ci of Sr-82 per mCi of Rb-82 chloride);
12.34.a.3. More than two-tenths (0.2) kilobecquerel of Strontium-85 per megabecquerel of Rubidium-82 chloride injection (two-tenths [(0.2] Ci of Sr-85 per mCi of Rb-82).
12.34.b. A registrant preparing radiopharmaceuticals from radionuclide generators shall measure the concentration of radionuclide contaminant in each eluate or extract, as appropriate for the generator system, to determine compliance with the limits specified in Subdivision 12.34.a.
12.34.c. A registrant who must measure radionuclide contaminant concentration shall retain a record of each measurement for three (3) years. The record shall include, for each elution or extraction tested, the measured activity of the radiopharmaceutical expressed in megabecquerels (mCi), the measured activity of contaminant expressed in kilobecquerels (Ci), the ratio of the measures expressed as kilobecquerels (Ci) of contaminant per megabecquerel (mCi) of radiopharmaceutical, the date of the test, and the initials of the individual who performed the test.
12.34.d. A registrant shall report immediately to the agency each occurrence of radionuclide contaminant concentration exceeding the limits specified in Subdivision 12.4.a.
12.35. Control of Aerosols and Gases.
12.35.a. A registrant who administers radioactive aerosols or gases shall do so with a system that will keep airborne concentrations within the limits prescribed in Section 6. of this rule.
12.35.b. The system shall either be directly vented to the atmosphere through an air exhaust or provide for collection and decay or disposal of the aerosol or gas in a shielded container.
12.35.c. A registrant shall only administer radioactive gases in rooms that are at negative pressure with respect to surrounding rooms.
12.35.d. Before receiving, using, or storing a radioactive gas, the registrant shall calculate the amount of time needed after a release to reduce the concentration in the area of use to the occupational limit listed in Table 64-23 F of this rule. The calculation shall be based on the highest activity of gas handled in a single container and the measured available air exhaust rate.
12.35.e. A registrant shall post the time calculated in Subdivision 12.35.d. at the area of use and require that, in case of a gas spill, individuals evacuate the room until the posted time has elapsed.
12.35.f. A registrant shall check the operation of collection systems monthly and measure the ventilation rates in areas of use at intervals not to exceed six (6) months. Records of these checks and measurements shall be maintained for three (3) years.
12.35.g. A copy of the calculations required in Subdivision 12.35.d. shall be recorded and retained for the duration of the registration.
12.36. Possession of Survey Instruments. A registrant authorized to use radioactive material for imaging and localization studies shall possess a portable radiation detection survey instrument capable of detecting dose rates over the range of one (1) microsievert (one-tenth [0.1] mRem) per hour to five hundred 500 microsieverts (fifty [50] mRems) per hour, and a portable radiation measurement survey instrument capable of measuring dose rates over the range ten (10) microsieverts (one [1] mRem) per hour to ten (10) millisieverts (one thousand [1000] mRems) per hour. The instruments shall be operable and calibrated in accordance with Subsection 12.18.
12.37. Use of Radiopharmaceuticals for Therapy. A registrant may use any radioactive material in a radiopharmaceutical and for a therapeutic use:
12.37.a. Which has been granted acceptance or approval by the Food and Drug Administration; or
12.37.b. Which has been prepared and compounded in accordance with the rules of the State Board of Pharmacy.
12.38. Safety Instruction.
12.38.a. A registrant shall provide oral and written radiation safety instruction for all personnel caring for patients undergoing radiopharmaceutical therapy. Refresher training shall be provided at intervals not to exceed one (1) year.
12.38.b. To satisfy Subdivision 12.38.a., the instruction shall describe the registrant 's procedures for:
12.38.b.1. Patient control;
12.38.b.2. Visitor control;
12.38.b.3. Contamination control;
12.38.b.4. Waste control;
12.38.b.5. Notification of the radiation safety officer or authorized user in case of the patient's death or medical emergency; and
12.38.b.6. Training for workers as required by Section 13. of this rule.
12.38.c. A registrant shall keep a record of individuals receiving instruction required by Subdivision 12.38.a., a description of the instruction, the date of instruction, and the name of the individual who gave the instruction. Such record shall be maintained for inspection by the agency for three (3) years.
12.39. Safety Precautions.
12.39.a. For each patient receiving radiopharmaceutical therapy and hospitalized for compliance with Subsection 12.27., a registrant shall:
12.39.a.1. Provide a private room with a private sanitary facility;
12.39.a.2. Post the patient's door with a "Caution: Radioactive Material" sign and note on the door or on the patient's chart where and how long visitors may stay in the patient's room;
12.39.a.3. Authorize visits by individuals under eighteen (18) years of age only on a case-by-case basis with the approval of the authorized user after consultation with the radiation safety officer;
12.39.a.4. Promptly after administration of the dosage, measure the dose rates in contiguous restricted and unrestricted areas with a radiation measurement survey instrument to demonstrate compliance with the requirements of Section d of this rule and retain for three (3) years a record of each survey that includes the time and date of the survey, a plan of the area or list of points surveyed, the measured dose rate at several points expressed in microsieverts (mRem) per hour, the instrument used to make the survey, and the initials of the individual who made the survey;
12.39.a.5. Either monitor material and items removed from the patient's room to determine that any contamination cannot be distinguished from the natural background radiation level with a radiation detection survey instrument set on its most sensitive scale and with no interposed shielding, or handle these materials and items as radioactive waste;
12.39.a.6. Instruct the patient and, where appropriate, the patient's family, orally and in writing concerning radiation safety precautions that will help to keep radiation dose to household members and the public as low as reasonably achievable before authorizing release of the patient;
12.39.a.7. Survey the patient's room and private sanitary facility for removable contamination with a radiation detection survey instrument before assigning another patient to the room. The room must not be reassigned until removable contamination is less than three and thirty three one-hundredths (3.33) becquerels (two hundred [200] dpm) per one hundred (100) square centimeters; and
12.39.a.8. Measure the thyroid burden of each individual who helped prepare or 0administer a dosage of I-131 within three (3) days after administering the dosage, and retain for the period required by Section 6. of this rule a record of each thyroid burden measurement, date of measurement, the name of the individual whose thyroid burden was measured, and the initials of the individual who made the measurements. Other procedures acceptable to the agency may be used for individuals who only prepare, but do not administer, doses of stabilized I-131.
12.39.b. For each non-hospitalized patient receiving radiopharmaceutical therapy, the registrant shall instruct the patient and, where appropriate, the patient's family, orally and in writing concerning radiation safety precautions that will help to keep radiation doses to the household members and the public as low as reasonably achievable.
12.39.c. The radiation safety officer or the authorized user shall be notified immediately if the hospitalized patient dies or has a medical emergency.
12.40. Possession of Survey Instruments. A registrant authorized to use radioactive material for radiopharmaceutical therapy shall possess a portable radiation detection survey instrument capable of detecting dose rates over the range one (1) microsievert (one-tenth [0.1] mRem) per hour to five hundred (500) microsieverts (fifty [50] mRems) per hour, and a portable radiation measurement survey instrument capable of measuring dose rates over the range ten (10) microsieverts (one [1] mRem) per hour to ten (10) millisieverts (one thousand [1000] mRems) per hour. The instruments shall be operable and calibrated in accordance with Subsection 12.18.
12.41. Use of Sealed Sources for Diagnosis. A registrant shall use the following sealed sources in accordance with the manufacturer's radiation safety and handling instructions:
12.41.a. Iodine-125 as a sealed source in a device for bone mineral analysis;
12.41.b. Americium-241 as a sealed source in a device for bone mineral analysis;
12.41.c. Gadolinium-153 as a sealed source in a device for bone mineral analysis or in a portable device for imaging; and
12.41.d. Iodine-125 as a sealed source in a portable device for imaging.
12.42. Availability of Survey Instrument. A registrant authorized to use radioactive material as a sealed source for diagnostic purposes shall have available for use a portable radiation detection survey instrument capable of detecting dose rates over the range one (1) microsievert (one-tenth [0.1] mRem) per hour to five hundred (500) microsieverts (fifty [50] mRems) per hour or a portable radiation measurement survey instrument capable of measuring dose rates over the range ten (10) microsieverts (one [1] mRem) per hour to ten (10) microsieverts (one thousand [1000] mRems) per hour. The instrument shall be operable and calibrated in accordance with Subsection 12.18.
12.43. Use of Sources for Brachytherapy. A registrant shall use the following sources in accordance with the manufacturer's radiation safety and handling instructions:
12.43.a. Cesium-137 as a sealed source in needles and applicator cells for topical, interstitial, and intracavitary treatment of cancer;
12.43.b. Cobalt-60 as a sealed source in needles and applicator cells for topical, interstitial, and intracavitary treatment of cancer;
12.43.c. Gold-198 as a sealed source in seeds for interstitial treatment of cancer;
12.43.d. Iodine-125 as a sealed source in seeds for interstitial treatment of cancer;
12.43.e. Iridium-192 as seeds encased in nylon ribbon for interstitial treatment of cancer;
12.43.f. Strontium-90 as a sealed source in an applicator for treatment of superficial eye conditions; and
12.43.g. Palladium-103 as a sealed source in seeds for the interstitial treatment of cancer.
12.44. Safety Instruction.
12.44.a. The registrant shall provide oral and written radiation safety instruction to all personnel caring for a patient receiving implant therapy. Refresher training shall be provided at intervals not to exceed one (1) year.
12.44.b. To satisfy Subdivision 12.44.a., the instruction shall describe:
12.44.b.1. Size and appearance of the brachytherapy sources;
12.44.b.2. Safe handling and shielding instructions in case of a dislodged source;
12.44.b.3. Procedures for patient control;
12.44.b.4. Procedures for visitor control;
12.44.b.5. Procedures for notification of the radiation safety officer or authorized user if the patient dies or has a medical emergency; and
12.44.b.6. Training for workers as required by Section 13. of this rule.
12.44.c. A registrant shall maintain a record of individuals receiving instruction required by Subdivision 12.44.a., a description of the instruction, the date of instruction, and the name of the individual who gave the instruction for three (3) years.
12.45. Safety Precautions.
12.45.a. For each patient receiving implant therapy a registrant shall:
12.45.a.1. Not place the patient in the same room with a patient who is not receiving radiation therapy unless the registrant can demonstrate compliance with the radiation dose limits for individual members of the public as specified in Section 6. of this rule at a distance of one (1) meter from the implant;
12.45.a.2. Post the patient's door with a "Caution: Radioactive Materials" sign and note on the door or the patient's chart where and how long visitors may stay in the patient's room;
12.45.a.3. Authorize visits by individuals under 18 years of age only on a case-by-case basis with the approval of the authorized user after consultation with the radiation safety officer;
12.45.a.4. Promptly after implanting the sources, survey the dose rates in contiguous restricted and unrestricted areas with a radiation measurement survey instrument to demonstrate compliance with Section 6 of this rule and retain for three (3) years a record of each survey that includes the time and date of the survey, a sketch of the area or list of points surveyed, the measured dose rate at several points expressed in microsieverts (mRems) per hour, the instrument used to make the survey, and the initials of the individual who made the survey; and
12.45.a.5. Before authorizing the release of a patient administered a permanent implant, instruct the patient, and where appropriate, the patient's family, orally and in writing concerning radiation safety precautions that will help keep the radiation dose to household members and the public as low as reasonably achievable.
12.45.b. The radiation safety officer or authorized user shall be notified immediately if the hospitalized patient dies or has a medical emergency.
12.46. Brachytherapy Sources Inventory.
12.46.a. Each time brachytherapy sources are returned to an area of storage from an area of use, the registrant shall immediately count or otherwise verify the number returned to ensure that all sources taken from the storage area have been returned.
12.46.b. A registrant shall make a record of brachytherapy source utilization which includes:
12.46.b.1. The names of the individuals permitted to handle the sources;
12.46.b.2. The number and activity of sources removed from storage, the room number of use and patient's name, the time and date they were removed from storage, the number and activity of sources in storage after the removal, and the initials of the individual who removed the sources from storage; and
12.46.b.3. The number and activity of sources returned to storage, the room number of use and patient's name, the time and date they were returned to storage, the number and activity of sources in storage after the return, and the initials of the individual who returned the sources to storage.
12.46.c. Immediately after implanting sources in a patient and immediately after removal of sources from a patient, the registrant shall make a radiation survey of the patient and the area of use to confirm that no sources have been misplaced. The registrant shall make a record of each survey.
12.46.d. A registrant shall maintain the records required in Subdivision 12.46.b. and c. for three (3) years.
12.47. Release of Patients Treated With Temporary Implants.
12.47.a. Immediately after removing the last temporary implant source from a patient, the registrant shall perform a radiation survey of the patient with a radiation detection survey instrument to confirm that all sources have been removed. The registrant shall not release from confinement for medical care a patient treated by temporary implant until all sources have been removed.
12.47.b. A registrant shall maintain a record of patient surveys which demonstrate compliance with Subdivision 12.47.a. for three (3) years. Each record shall include the date of the survey, the name of the patient, the dose rate from the patient expressed as microsieverts (mRems) per hour and measured within 1 meter from the patient, and the initials of the individual who made the survey.
12.48. Possession of Survey Instruments. A registrant authorized to use radioactive material for implant therapy shall possess a portable radiation detection survey instrument capable of detecting dose rates over the range one (1) microsievert (one-tenth [0.1] mRem) per hour to five hundred (500) microsieverts (fifty [50] mRems) per hour, and a portable radiation measurement survey instrument capable of measuring dose rates over the range ten (10) microsieverts (one [1] mRem) per hour to ten (10) millisieverts (one thousand [1000] mRems) per hour. The instruments shall be operable and calibrated in accordance with Subsection 12.18.
12.49. Use of a Sealed Source in a Teletherapy Unit. A registrant shall use Cobalt-60 or cesium-137 as a sealed source in a teletherapy unit for medical use in accordance with the manufacturer's radiation safety and operating instructions.
12.50. Maintenance and Repair Restrictions. Only a person specifically licensed by the Nuclear Regulatory Commission, or an agreement state to perform teletherapy unit maintenance and repair shall install, relocate, or remove a teletherapy sealed source or a teletherapy unit that contains a sealed source or maintain, adjust, or repair the source drawer, the shutter or other mechanism of a teletherapy unit that could expose the source, reduce the shielding around the source, or result in increased radiation levels.
12.51. Amendments. In addition to the requirements specified in Subsection 12.4, a registrant shall apply for and receive a registration amendment before:
12.51.a. Making any change in the treatment room shielding;
12.51.b. Making any change in the location of the teletherapy unit within the treatment room;
12.51.c. Using the teletherapy unit in a manner that could result in increased radiation levels in areas outside the teletherapy treatment room;
12.51.d. Relocating the teletherapy unit; or
12.51.e. Allowing an individual not listed on the registrant 's registration to perform the duties of the teletherapy physicist.
12.52. Safety Instruction.
12.52.a. A registrant shall conspicuously post written instructions at the teletherapy unit console. These instructions shall inform the operator of:
12.52.a.1. The procedure to be followed to ensure that only the patient is in the treatment room before turning the primary beam of radiation "on" to begin a treatment or after a door interlock interruption;
12.52.a.2. The procedure to be followed if the operator is unable to turn the primary beam of radiation "off" with controls outside the treatment room or any other abnormal operation occurs; and
12.52.a.3. The names and telephone numbers of the authorized users and radiation safety officer to be immediately contacted if the teletherapy unit or console operates abnormally.
12.52.b. A registrant shall provide instruction in the topics identified in Subdivision 12.52.a. to all individuals who operate a teletherapy unit and shall provide appropriate refresher training to individuals at intervals not to exceed one (1) year.
12.52.c. A registrant shall maintain a record of individuals receiving instruction required by 12.52.b., a description of the instruction, the date of instruction, and the name of the individual who gave the instruction for three (3) years.
12.53. Doors, Interlocks, and Warning Systems.
12.53.a. A registrant shall control access to the teletherapy room by a door at each entrance.
12.53.b. A registrant shall equip each entrance to the teletherapy room with an electrical interlock system that shall:
12.53.b.1. Prevent the operator from turning the primary beam of radiation "on" unless each treatment room entrance door is closed;
12.53.b.2. Turn the beam of radiation "off" immediately when an entrance door is opened; and
12.53.b.3. Prevent the primary beam of radiation from being turned "on" following an interlock interruption until all treatment room entrance doors are closed and the beam on-off control is reset at the console.
12.53.c. A registrant shall equip each entrance to the teletherapy room with a conspicuously visible beam condition indicator light.
12.54. Possession of Survey Instrument. A registrant authorized to use radioactive material in a teletherapy unit shall possess either a portable radiation detection survey instrument capable of detecting dose rates over the range one (1) microsievert (one-tenth [0.1] mRem) per hour to five hundred (500) microsieverts (fifty [50] mRems) per hour or a portable radiation measurement survey instrument capable of measuring dose rates over the range 10 microsieverts (1 mRem) per hour to ten (10) microsieverts (one thousand [1000] mRems) per hour. The instruments shall be operable and calibrated in accordance with Subsection 12.18.
12.55. Radiation Monitoring Device.
12.55.a. A registrant shall have in each teletherapy room a permanent radiation monitor capable of continuously monitoring beam status.
12.55.b. Each radiation monitor shall be capable of providing visible notice of a teletherapy unit malfunction that results in an exposed or partially exposed source. The visible indicator of high radiation levels shall be observable by an individual entering the teletherapy room.
12.55.c. Each radiation monitor shall be equipped with a backup power supply separate from the power supply to the teletherapy unit. This backup power supply may be a battery system.
12.55.d. A radiation monitor shall be checked with a dedicated check source for proper operation each day before the teletherapy unit is used for treatment of patients.
12.55.e. A registrant shall maintain a record of the check required by Subdivision 12.55.d. for 3 years. The record shall include the date of the check, notation that the monitor indicates when the source is exposed, and the initials of the individual who performed the check.
12.55.f. If a radiation monitor is inoperable, the registrant shall require any individual entering the teletherapy room to use a survey instrument or audible alarm personal dosimeter to monitor for any malfunction of the source exposure mechanism. The instrument or dosimeter shall be checked with a dedicated check source for proper operation at the beginning of each day of use. The registrant shall keep a record as described in Subdivision 12.55.e.
12.55.g. A registrant shall promptly repair or replace the radiation monitor if it is inoperable.
12.56. Viewing System. A registrant shall construct or equip each teletherapy room to permit continuous observation of the patient from the teletherapy unit console during irradiation.
12.57. Dosimetry Equipment.
12.57.a. A registrant shall have a calibrated dosimetry system available for use. To satisfy this requirement, one of the following two conditions shall be met:
12.57.a.1. The system shall have been calibrated by the national institute of standards and technology or by a calibration laboratory accredited by the American Association of Physicists in Medicine. The calibration shall have been performed within the previous two (2) years and after any servicing that may have affected system calibration; or
12.57.a.2. The system shall have been calibrated within the previous four (4) years; eighteen (18) to thirty (30) months after that calibration, the system shall have been intercompared at an intercomparison meeting with another dosimetry system that was calibrated within the past 24 months by the national institute of standards and technology or by a calibration laboratory accredited by the American Association of Physicists in Medicine. The intercomparison meeting shall be sanctioned by a calibration laboratory or radiologic physics center accredited by the American Association of Physicists in Medicine. The results of the intercomparison meeting must have indicated that the calibration factor of the registrant’s system had not changed by more than two (2) percent. The registrant shall not use the intercomparison result to change the calibration factor. When intercomparing dosimetry systems to be used for calibrating Cobalt-60 teletherapy units, the registrant shall use a teletherapy unit with a Cobalt-60 source. When intercomparing dosimetry systems to be used for calibrating Cesium-137 teletherapy units, the registrant shall use a teletherapy unit with a Cesium-137 source.
12.57.b. The registrant shall have available for use a dosimetry system for spot-check measurements. To meet this requirement, the system may be compared with a system that has been calibrated in accordance with Subdivision 12.57.a. This comparison shall have been performed within the previous year and after each servicing that may have affected system calibration. The spot-check system shall be the same system used to meet the requirement in Subdivision 12.57.a.
12.57.c. The registrant shall maintain a record of each calibration, intercomparison, and comparison for the duration of the registration. For each calibration, intercomparison, or comparison, the record shall include the date, the model numbers and serial numbers of the instruments that were calibrated, intercompared, or compared as required by Subdivision 12.57.a. and b., the correction factors that were determined, the names of the individuals who performed the calibration, intercomparison, or comparison, and evidence that the intercomparison meeting was sanctioned by a calibration laboratory or radiologic physics center accredited by the American Association of Physicists in Medicine.
12.58. Full Calibration Measurements.
12.58.a. A registrant authorized to use a teletherapy unit for medical use shall perform full calibration measurements on each teletherapy unit:
12.58.a.1. Before the first medical use of the unit;
12.58.a.2. Before medical use under the following conditions:
12.58.a.2.A. Whenever spot-check measurements indicate that the output differs by more than five (5) percent from the output obtained at the last full calibration corrected mathematically for radioactive decay;
12.58.a.2.B. Following replacement of the source or following reinstallation of the teletherapy unit in a new location; and
12.58.a.2.C. Following any repair of the teletherapy unit that includes removal of the source or major repair of the components associated with the source exposure assembly; and
12.58.a.3. At intervals not exceeding 1 year.
12.58.b. To satisfy the requirement of Subdivision 12.58.a., full calibration measurements shall include determination of:
12.58.b.1. The output within three (3) percent for the range of field sizes and for the distance or range of distances used for medical use;
12.58.b.2. The coincidence of the radiation field and the field indicated by the light beam localizing device;
12.58.b.3. The uniformity of the radiation field and its dependence on the orientation of the useful beam;
12.58.b.4. Timer accuracy, constancy, and linearity;
12.58.b.5. "On-off" error; and
12.58.b.6. The accuracy of all distance measuring and localization devices in medical use.
12.58.c. A registrant shall use the dosimetry system described in Subsection 12.57. to measure the output for 1 set of exposure conditions. The remaining radiation measurements required in Paragraph 12.58.b.1. may then be made using a dosimetry system that indicates relative dose rates.
12.58.d. A registrant shall make full calibration measurements required by Subdivision 12.58.a. in accordance with the measurements required for annual calibration by "Comprehensive QA for Radiation Oncology: Report of AAPM Radiation Therapy Committee Task Group 40," Medical Physics, vol. 21, no. 4, 1994, pp. 581-618.
12.58.e. A registrant shall correct mathematically the outputs determined in Paragraph 12.58.b.1. for physical decay for intervals not exceeding one (1) month for Cobalt-60 and intervals not exceeding six (6) months for cesium-137.
12.58.f. Full calibration measurements required by Subdivision 12.58.a. and physical decay corrections required by Subdivision 12.58.e. shall be performed by a teletherapy physicist named on the registrant’s registration or authorized by a registration issued by the Nuclear Regulatory Commission or an agreement state to perform such services.
12.58.g. A registrant shall maintain a record of each calibration for the duration of the registration. The record shall include the date of the calibration, the manufacturer's name, model number, and serial number for both the teletherapy unit and the source, the model numbers and serial numbers of the instruments used to calibrate the teletherapy unit, Tables that describe the output of the unit over the range of field sizes and for the range of distances used in radiation therapy, a determination of the coincidence of the radiation field and the field indicated by the light beam localizing device, the measured timer accuracy for a typical treatment time, the calculated "on-off" error, the estimated accuracy of each distance measuring or localization device, and the signature of the teletherapy physicist.
12.59. Periodic Spot Checks.
12.59.a. A registrant authorized to use teletherapy units for medical use shall perform output spot checks on each teletherapy unit at intervals not to exceed one (1) month.
12.59.b. To satisfy the requirement of Subdivision 12.59.a., spot checks shall include determination of:
12.59.b.1. Timer constancy and timer linearity over the range of use;
12.59.b.2. "On-off" error;
12.59.b.3. The coincidence of the radiation field and the field indicated by the light beam localizing device;
12.59.b.4. The accuracy of all distance measuring and localization devices used for medical use;
12.59.b.5. The output for 1 typical set of operating conditions; and
12.59.b.6. The difference between the measurement made in Paragraph 12.59.b.5. and the anticipated output, expressed as a percentage of the anticipated output (i.e., the value obtained at last full calibration corrected mathematically for physical decay).
12.59.c. A registrant shall use the dosimetry system described in Subsection 12.57. to make the spot check required in Paragraph 12.59.b.5.
12.59.d. A registrant shall perform spot checks required by Subdivision 12.59.a. in accordance with procedures established by the teletherapy physicist. The teletherapy physicist does not need to actually perform the output spot-check measurements.
12.59.e. A registrant shall have the teletherapy physicist review the results of each output spot check within fifteen (15) days. The teletherapy physicist shall promptly notify the registrant in writing of the results of each output spot check. The registrant shall keep a copy of each written notification for two (2) years.
12.59.f. A registrant authorized to use a teletherapy unit for medical use shall perform safety spot checks of each teletherapy facility at intervals not to exceed one (1) month.
12.59.g. To satisfy the requirement of Subsection 12.59.f., safety spot checks shall assure proper operation of:
12.59.g.1. Electrical interlocks at each teletherapy room entrance;
12.59.g.2. Electrical or mechanical stops installed for the purpose of limiting use of the primary beam of radiation restriction of source housing angulation or elevation, carriage or stand travel, and operation of the beam "on-off" mechanism;
12.59.g.3. Beam condition indicator lights on the teletherapy unit, on the control console, and in the facility;
12.59.g.4. Viewing systems;
12.59.g.5. Treatment room doors from inside and outside the treatment room; and
12.59.g.6. Electrically assisted treatment room doors with the teletherapy unit electrical power turned "off."
12.59.h. A registrant shall lock the control console in the "off" position if any door interlock malfunctions. No registrant shall use the unit until the interlock system is repaired unless specifically authorized by the agency.
12.59.i. A registrant shall promptly repair any system identified in Subdivision 12.59.g. that is not operating properly. The teletherapy unit shall not be used until all repairs are completed.
12.59.j. A registrant shall maintain a record of each spot check required by Subdivision 12.59.a. and f. for three (3) years. The record shall include the date of the spot check, the manufacturer's name, model number, and serial number for both the teletherapy unit, and source, the manufacturer's name, model number and serial number of the instrument used to measure the output of the teletherapy unit, the timer constancy and linearity, the calculated "on-off" error, a determination of the coincidence of the radiation field and the field indicated by the light beam localizing device, the timer constancy and linearity for a typical treatment time, the calculated "on-off" error, the estimated accuracy of each distance measuring or localization device, the difference between the anticipated output and the measured output, notations indicating the operability of each entrance door electrical interlock, each electrical or mechanical stop, each beam condition indicator light, the viewing system and doors, and the signature of the individual who performed the periodic spot check.
12.60. Radiation Surveys for Teletherapy Facilities.
12.60.a. Before medical use, after each installation of a teletherapy source, and after making any change for which an amendment is required by Subsection 12.51., the registrant shall perform radiation surveys with an operable radiation measurement survey instrument calibrated in accordance with Subsection 12.18. to verify that:
12.60.a.1. The maximum and average radiation levels at 1 meter from the teletherapy source with the source in the "off" position and the collimators set for a normal treatment field do not exceed one hundred (100) microsieverts (ten [10] mRems) per hour and twenty (20) microsieverts (two [2] mRems) per hour, respectively; and
12.60.a.2. With the teletherapy source in the "on" position with the largest clinically available treatment field and with a scattering phantom in the primary beam of radiation, that:
12.60.a.2.A. Radiation levels in restricted areas are not likely to cause personnel exposures in excess of the limits specified in Section 6. of this rule; and
12.60.a.2.B. Radiation levels in unrestricted areas do not exceed the limits specified in Section 6. of this rule.
12.60.b. If the results of the surveys required in Subdivision 12.60.a. indicate any radiation levels in excess of the respective limit specified in that Paragraph, the registrant shall lock the control in the "off" position and not use the unit:
12.60.b.1. Except as may be necessary to repair, replace, or test the teletherapy unit, the teletherapy unit shielding, or the treatment room shielding; or
12.60.b.2. Until the registrant has received a specific exemption from the agency.
12.60.c. A registrant shall maintain a record of the radiation measurements made following installation of a source for the duration of the registration. The record shall include the date of the measurements, the reason the survey is required, the manufacturer's name, model number and serial number of the teletherapy unit, the source, and the instrument used to measure radiation levels, each dose rate measured around the teletherapy source while in the "off" position and the average of all measurements, a plan of the areas surrounding the treatment room that were surveyed, the measured dose rate at several points in each area expressed in microsieverts (mRems) per hour, the calculated maximum level of radiation over a period of one (1) week for each restricted and unrestricted area, and the signature of the radiation safety officer.
12.61. Safety Spot Checks for Teletherapy Facilities.
12.61.a. A registrant shall promptly check all systems listed in Subdivision 12.59.g. for proper function after each installation of a teletherapy source and after making any change for which an amendment is required by Subsection 12.51.
12.61.b. If the results of the safety spot checks required in Subdivision 12.61.a. indicate the malfunction of any system specified in Subsection 12.59., the registrant shall lock the control console in the "off" position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.
12.61.c. A registrant shall maintain a record of the safety spot checks following installation of a source for three (3) years. The record shall include notations indicating the operability of each entrance door interlock, each electrical or mechanical stop, each beam condition indicator light, the viewing system, doors, and the signature of the radiation safety officer.
12.62. Modification of Teletherapy Unit or Room Before Beginning a Treatment Program. If the survey required by Subsection 12.60. indicates that an individual in an unrestricted area may be exposed to levels of radiation greater than those permitted by Section 6 of this rule, before beginning the treatment program the registrant shall:
12.62.a. Either equip the unit with stops or add additional radiation shielding to ensure compliance with Section 6. of this rule;
12.62.b. Perform the survey required by Subsection 12.60. again; and
12.62.c. Include in the report required by Subsection 12.63. the results of the initial survey, a description of the modification made to comply with Subdivision 12.62.a., and the results of the second survey; or
12.62.d. Request and receive a registration amendment under Section 6. of this rule that authorizes radiation levels in unrestricted areas greater than those permitted by Section 6. of this rule.
12.63. Reports of Teletherapy Surveys, Checks, Tests, and Measurements. A registrant shall furnish a copy of the records required in Subsections 12.60.,.12.61., and 12.62., and the output from the teletherapy source expressed as grays (Rads) per hour at 1 meter from the source as determined during the full calibration required in Subsection 12.58. to the agency within thirty (30) days following completion of the action that initiated the record requirement.
12.64. Five-Year Inspection.
12.64.a. A registrant shall have each teletherapy unit fully inspected and serviced during teletherapy source replacement or at intervals not to exceed five (5) years, whichever comes first, to assure proper functioning of the source exposure mechanism.
12.64.b. This inspection and servicing shall only be performed by persons specifically registered to do so by an agreement state, or the Nuclear Regulatory Commission.
12.64.c. A registrant shall maintain a record of the inspection and servicing for the duration of the registration. The record shall contain the inspector's name, the inspector's registration number, the date of inspection, the manufacturer's name and model number and serial number for both the teletherapy unit and source, a list of components inspected, a list of components serviced and the type of service, a list of components replaced, and the signature of the inspector.
12.65. Training Requirements for Radiation Safety Officers. Except as provided in Subsection 12.66., an individual fulfilling the responsibilities of the radiation safety officer as provided in Section 12.7. shall:
12.65.a. Be certified by the:
12.65.a.1. American Board of Health Physics in Comprehensive Health Physics; or
12.65.a.2. American Board of Radiology in Radiological Physics, Therapeutic Radiological Physics, or Medical Nuclear Physics; or
12.65.a.3. American Board of Nuclear Medicine; or
12.65.a.4. American Board of Science in Nuclear Medicine; or
12.65.a.5. Board of Pharmaceutical Specialties in Nuclear Pharmacy or Science; or
12.65.a.6. American Board of Medical Physics in Radiation Oncology Physics; or
12.65.a.7. Royal College of Physicians and Surgeons of Canada in Nuclear Medicine; or
12.65.a.8. American Osteopathic Board of Radiology; or
12.65.a.9. American Osteopathic Board of Nuclear Medicine; or
12.65.b. Have had two hundred (200) hours of classroom and laboratory training covering:
12.65.b.1. Radiation physics and instrumentation;
12.65.b.2. Radiation protection;
12.65.b.3. Mathematics pertaining to the use and measurement of radioactivity;
12.65.b.4. Radiation biology;
12.65.b.5. Radiopharmaceutical chemistry; and
12.65.b.6. Have had one (1) year of full-time experience in radiation safety at a medical institution under the supervision of the individual identified as the radiation safety officer on an agency, agreement state, licensing state, or the Nuclear Regulatory Commission registration or registration that authorizes the medical use of radioactive material; or
12.65.c. Be an authorized user for those radioactive material uses that come within the radiation safety officer's responsibilities.
12.66. Training for Experienced Radiation Safety Officer. An individual identified as a radiation safety officer on an agency, agreement state, licensing state, or Nuclear Regulatory Commission registration or registration on July 1, 2001 who oversees only the use of radioactive material for which the registrant was authorized on that date need not comply with the training requirements of Subsection 12.65.
12.67. Training for Uptake, Dilution, or Excretion Studies. Except as provided in Subsection 12.75. and 12.76., the registrant shall require the authorized user of a radiopharmaceutical listed in Subsection 12.31. to be a physician who:
12.67.a. Is certified in:
12.67.a.1. Nuclear medicine by the American Board of Nuclear Medicine; or
12.67.a.2. Diagnostic Radiology by the American Board of Radiology; or
12.67.a.3. Diagnostic radiology or radiology by the American Osteopathic Board of Radiology; or
12.67.a.4. Nuclear medicine by the American Osteopathic Board of Nuclear Medicine; or
12.67.a.5. Nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or
12.67.b. Has completed forty (40) hours of instruction in basic radionuclide handling techniques applicable to the use of prepared radiopharmaceuticals, and twenty (20) hours of supervised clinical experience.
12.67.b.1. To satisfy the basic instruction requirement, forty (40) hours of classroom and laboratory instruction shall include:
12.67.b.1.A. Radiation physics and instrumentation;
12.67.b.1.B. Radiation protection;
12.67.b.1.C. Mathematics pertaining to the use and measurement of radioactivity;
12.67.b.1.D. Radiation biology; and
12.67.b.1.E. Radiopharmaceutical chemistry.
12.67.b.2. To satisfy the requirement for twenty (20) hours of supervised clinical experience, training must be under the supervision of an authorized user at a medical institution and shall include:
12.67.b.2.A. Examining patients and reviewing their case histories to determine their suitability for radionuclide diagnosis, limitations, or contraindications;
12.67.b.2.B. Selecting the suitable radiopharmaceuticals and calculating and measuring the dosages;
12.67.b.2.C. Administering dosages to patients and using syringe radiation shields;
12.67.b.2.D. Collaborating with the authorized user in the interpretation of radionuclide test results; and
12.67.b.2.E. Patient followup; or
12.67.b.2.F. Has successfully completed a six-month training program in nuclear medicine as part of a training program that has been approved by the accreditation council for graduate medical education and that included classroom and laboratory training, work experience, and supervised clinical experience in all the topics identified in Subdivision 12.67.b.
12.68. Training for Imaging and Localization Studies. Except as provided in Subsection 12.75. or 12.76. the registrant shall require the authorized user of a radiopharmaceutical, generator, or reagent kit specified in Subsection 12.33. to be a physician who:
12.68.a. Is certified in:
12.68.a.1. Nuclear medicine by the American Board of Nuclear Medicine; or
12.68.a.2. Diagnostic radiology by the American Board of Radiology; or
12.68.a.3. Diagnostic radiology or radiology by the American Osteopathic Board of Radiology; or
12.68.a.4. Nuclear medicine by the American Osteopathic Board of Nuclear Medicine; or
12.68.a.5. Nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or
12.68.b. Has completed two hundred (200) hours of instruction in basic radionuclide handling techniques applicable to the use of prepared radiopharmaceuticals, generators, and reagent kits, 500 hours of supervised work experience, and five hundred (500) hours of supervised clinical experience.
12.68.b.1. To satisfy the basic instruction requirement, two hundred (200) hours of classroom and laboratory training shall include:
12.68.b.1.A. Radiation physics and instrumentation;
12.68.b.1.B. Radiation protection;
12.68.b.1.C. Mathematics pertaining to the use and measurement of radioactivity;
12.68.b.1.D. Radiopharmaceutical chemistry; and
12.68.b.1.E. Radiation biology.
12.68.b.2. To satisfy the requirement for five hundred (500) hours of supervised work experience, training shall be under the supervision of an authorized user at a medical institution and shall include:
12.68.b.2.A. Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
12.68.b.2.B. Calibrating dose calibrators and diagnostic instruments and performing checks for proper operation of survey meters;
12.68.b.2.C. Calculating and safely preparing patient dosages;
12.68.b.2.D. Using administrative controls to prevent the misadministration of radioactive material;
12.68.b.2.E. Using emergency procedures to contain spilled radioactive material safely and using proper decontamination procedures; and
12.68.b.2.F. Eluting Technetium-99m from generator systems, assaying and testing the eluate for molybdenum-99 and alumina contamination, and processing the eluate with reagent kits to prepare Technetium-99m labeled radiopharmaceuticals.
12.68.b.3. To satisfy the requirement for five hundred (500) hours of supervised clinical experience, training shall be under the supervision of an authorized user at a medical institution and shall include:
12.68.b.3.A. Examining patients and reviewing their case histories to determine their suitability for radionuclide diagnosis, limitations, or contraindications;
12.68.b.3.B. Selecting the suitable radiopharmaceuticals and calculating and measuring the dosages;
12.68.b.3.C. Administering dosages to patients and using syringe radiation shields;
12.68.b.3.D. Collaborating with the authorized user in the interpretation of radionuclide test results; and
12.68.b.3.E. Patient followup; or
12.68.c. Has successfully completed a six-month training program in nuclear medicine as part of a training program that has been approved by the accreditation council for graduate medical education and that included classroom and laboratory training, work experience, and supervised clinical experience in all the topics identified in Subdivision 12.68.b.
12.69. Training for Therapeutic Use of Radiopharmaceuticals. Except as provided in Subsection 12.75., the registrant shall require the authorized user of a radiopharmaceutical listed in Subsection 12.37. for therapy to be a physician who:
12.69.a. Is certified in:
12.69.a.1. Nuclear medicine by the American Board of Nuclear Medicine; or
12.69.a.2. Radiation oncology, therapeutic radiology, or radiology by the American Board of Radiology; or
12.69.a.3. Nuclear medicine or radiation oncology by the American Osteopathic Board of Radiology after 1984; or
12.69.a.4. Nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or
12.69.b. Has completed eighty (80) hours of instruction in basic radionuclide handling techniques applicable to the use of therapeutic radiopharmaceuticals, and has had supervised clinical experience.
12.69.b.1. To satisfy the requirement for instruction, eighty (80) hours of classroom and laboratory training shall include:
12.69.b.1.A. Radiation physics and instrumentation;
12.69.b.1.B. Radiation protection;
12.69.b.1.C. Mathematics pertaining to the use and measurement of radioactivity; and
12.69.b.1.D. Radiation biology;
12.69.b.2. To satisfy the requirement for supervised clinical experience, training shall be under the supervision of an authorized user at a medical institution and shall include:
12.69.b.2.A. Use of Iodine-131 for diagnosis of thyroid function and the treatment of hyperthyroidism or cardiac dysfunction in ten (10) individuals;
12.69.b.2.B. Use of soluble Phosphorus-32 for the treatment of ascites, polycythemia vera, leukemia, or bone metastases in three individuals;
12.69.b.2.C. Use of Iodine-131 for treatment of thyroid carcinoma in three (3) individuals;
12.69.b.2.D. Use of colloidal chromic Phosphorus-32 or of colloidal Gold-198 for intracavitary treatment of malignant effusions in three individuals; and
12.69.b.2.E. Use of strontium-89 as strontium chloride for the treatment of pain associated with bone metastases in three individuals.
12.70. Training for Therapeutic Use of Brachytherapy Sources. Except as provided in Subsection 12.75., the registrant shall require the authorized user using a brachytherapy source specified in Subsection 12.43. for therapy to be a physician who:
12.70.a. Is certified in:
12.70.a.1. Radiology, therapeutic radiology, or radiation oncology by the American Board of Radiology; or
12.70.a.2. Radiation oncology by the American Osteopathic Board of Radiology; or
12.70.a.3. Radiology, with a specialization in radiotherapy, as a British "Fellow of the Faculty of Radiology" or "Fellow of the Royal College of Radiology"; or
12.70.a.4. Therapeutic radiology by the canadian royal college of physicians and surgeons; or
12.70.b. Is in the active practice of therapeutic radiology, has completed two hundred (200) hours of instruction in basic radionuclide handling techniques applicable to the therapeutic use of brachytherapy sources and five hundred (500) hours of supervised work experience and a minimum of three (3) years of supervised clinical experience.
12.70.b.1. To satisfy the requirement for instruction, two hundred (200) hours of classroom and laboratory training shall include:
12.70.b.1.A. Radiation physics and instrumentation;
12.70.b.1.B. Radiation protection;
12.70.b.1.C. Mathematics pertaining to the use and measurement of radioactivity; and
12.70.b.1.D. Radiation biology.
12.70.b.2. To satisfy the requirement for five hundred (500) hours of supervised work experience, training shall be under the supervision of an authorized user at a medical institution and shall include:
12.70.b.2.A. Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
12.70.b.2.B. Checking survey meters for proper operation;
12.70.b.2.C. Preparing, implanting, and removing sealed sources;
12.70.b.2.D. Using administrative controls to prevent the misadministration of radioactive material; and
12.70.b.2.E. Using emergency procedures to control radioactive material.
12.70.b.3. To satisfy the requirement for a period of supervised clinical experience, training shall include one (1) year in a formal training program approved by the Residency Review Committee for Radiology of the Accreditation Council for Graduate Medical Education or the Committee on Postdoctoral Training of the American Osteopathic Association, and an additional two (2) years of clinical experience in therapeutic radiology under the supervision of an authorized user at a medical institution. The supervised clinical experience shall include:
12.70.b.3.A. Examining individuals and reviewing their case histories to determine their suitability for brachytherapy treatment, and any limitations or contraindications;
12.70.b.3.B. Selecting the proper brachytherapy sources, dose, and method of administration;
12.70.b.3.C. Calculating the dose; and
12.70.b.3.D. Post-administration followup and review of case histories in collaboration with the authorized user.
12.71. Training for Ophthalmic Use of Strontium-90. Except as provided in Subsection 12.75., the registrant shall require the authorized user using only Strontium-90 for ophthalmic radiotherapy to be a physician who:
12.71.a. Is certified in radiology, therapeutic radiology, or radiation oncology by the American Board of Radiology; or
12.71.b. Is in the active practice of therapeutic radiology or ophthalmology, and has completed twenty four (24) hours of instruction in basic radionuclide handling techniques applicable to the use of Strontium-90 for ophthalmic radiotherapy, and a period of supervised clinical training in ophthalmic radiotherapy.
12.71.b.1. To satisfy the requirement for instruction, the classroom and laboratory training shall include:
12.71.b.1.A. Radiation physics and instrumentation;
12.71.b.1.B. Radiation protection;
12.71.b.1.C. Mathematics pertaining to the use and measurement of radioactivity; and
12.71.b.1.D. Radiation biology.
12.71.b.2. To satisfy the requirement for a period of supervised clinical training in ophthalmic radiotherapy, training shall be under the supervision of an authorized user at a medical institution and shall include the use of strontium-90 for the ophthalmic treatment of five (5) individuals that includes:
12.71.b.2.A. Examination of each individual to be treated;
12.71.b.2.B. Calculation of the dose to be administered;
12.71.b.2.C. Administration of the dose; and
12.71.b.2.D. Followup and review of each individual's case history.
12.72. Training for Use of Sealed Sources for Diagnosis. Except as provided in Subsection 12.75., the registrant shall require the authorized user using a sealed source in a device specified in Subsection 12.41. to be a physician, dentist, or podiatrist who:
12.72.a. Is certified in:
12.72.a.1. Radiology, diagnostic radiology with special competence in nuclear radiology, therapeutic radiology, or radiation oncology by the American Board of Radiology; or
12.72.a.2. Nuclear medicine by the American Board of Nuclear Medicine; or
12.72.a.3. Diagnostic radiology or radiology by the American Osteopathic Board of Radiology; or
12.72.a.4. Nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or
12.72.b. Has completed eight (8) hours of classroom and laboratory instruction in basic radionuclide handling techniques specifically applicable to the use of the device.
12.72.b.1. To satisfy the requirement for instruction, the training shall include:
12.72.b.1.A. Radiation physics, mathematics pertaining to the use and measurement of radioactivity, and instrumentation;
12.72.b.1.B. Radiation biology; and
12.72.b.1.C. Radiation protection and training in the use of the device for the purposes authorized by the registration.
12.73. Training for Teletherapy. Except as provided in Subsection 12.75., the registrant shall require the authorized user of a sealed source specified in Subsection 12.49. in a teletherapy unit to be a physician who:
12.73.a. Is certified in:
12.73.a.1. Radiology, therapeutic radiology, or radiation oncology by the American Board of Radiology; or
12.73.a.2. Radiation oncology by the American Osteopathic Board of Radiology; or
12.73.a.3. Radiology, with specialization in radiotherapy, as a British "Fellow of the Faculty of Radiology" or "Fellow of the Royal College of Radiology"; or
12.73.a.4. Therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; or
12.73.b. Is in the active practice of therapeutic radiology, and has completed two hundred (200) hours of instruction in basic radionuclide techniques applicable to the use of a sealed source in a teletherapy unit, five hundred (500) hours of supervised work experience, and a minimum of three (3) years of supervised clinical experience.
12.73.b.1. To satisfy the requirement for instruction, the classroom and laboratory training shall include:
12.73.b.1.A. Radiation physics and instrumentation;
12.73.b.1.B. Radiation protection;
12.73.b.1.C. Mathematics pertaining to the use and measurement of radioactivity; and
12.73.b.1.D. Radiation biology.
12.73.b.2. To satisfy the requirement for five hundred (500) hours of supervised work experience, training shall be under the supervision of an authorized user at an institution and shall include:
12.73.b.2.A. Review of the full calibration measurements and periodic spot checks;
12.73.b.2.B. Preparing treatment plans and calculating treatment times;
12.73.b.2.C. Using administrative controls to prevent misadministrations;
12.73.b.2.D. Implementing emergency procedures to be followed in the event of the abnormal operation of a teletherapy unit or console; and
12.73.b.2.E. Checking and using survey meters.
12.73.b.3. To satisfy the requirement for a period of supervised clinical experience, training shall include 1 year in a formal training program approved by the residency review committee for radiology of the accreditation council for graduate medical education or the committee on postdoctoral training of the american osteopathic association and an additional two (2) years of clinical experience in therapeutic radiology under the supervision of an authorized user at a medical institution. The supervised clinical experience shall include:
12.73.b.3.A. Examining individuals and reviewing their case histories to determine their suitability for teletherapy treatment, and any limitations or contraindications;
12.73.b.3.B. Selecting the proper dose and how it is to be administered;
12.73.b.3.C. Calculating the teletherapy doses and collaborating with the authorized user in the review of patients' progress and consideration of the need to modify originally prescribed doses as warranted by patients' reaction to radiation; and
12.73.b.3.D. Post-administration followup and review of case histories.
12.74. Training for Teletherapy Physicist. The registrant shall require the teletherapy physicist to:
12.74.a. Be certified by the American Board of Radiology in:
12.74.a.1. Therapeutic radiological physics;
12.74.a.2. Roentgen-ray and gamma-ray physics;
12.74.a.3. X-ray and radium physics; or
12.74.a.4. Radiological physics; or
12.74.b. Be certified by the American Board of Medical Physics in Radiation Oncology Physics; or
12.74.c Hold a master's or doctor's degree in physics, biophysics, radiological physics, or health physics, and have completed 1 year of full time training in therapeutic radiological physics and also one (1) year of full time work experience under the supervision of a teletherapy physicist at a medical institution. To meet this requirement, the individual shall have performed the tasks listed in Subsection 12.21., 12.58., 12.59., and 12.60. under the supervision of a teletherapy physicist during the year of work experience.
12.75. Training for Experienced Authorized Users. Practitioners of the healing arts identified as authorized users for the human use of radioactive material on an agency, the Nuclear Regulatory Commission or agreement state or licensing state registration or registration on July 1, 2001 who perform only those methods of use for which they were authorized on that date need not comply with the training requirements of Subsections 12.65 through 12.77.
12.76. Physician Training in a Three-Month Program. A physician who, before July 1, 1984, began a three-month nuclear medicine training program approved by the accreditation council for graduate medical education and has successfully completed the program, is exempted from the requirements of Subsections 12.67 or 12.68.
12.77. Recentness of Training. The training and experience specified in Subsection 12.65.through 12.74. shall have been obtained within the five (5) years preceding the date of application or the individual shall have had continuing applicable experience since the required training and experience was completed.
W. Va. Code R. § 64-23-13 Notices, Instructions and Reports to Workers; Inspections
13.1. Purpose and Scope. This Section establishes requirements for notices, instructions and reports by registrants to individuals engaged in activities under a registration and options available to such individuals in connection with agency inspections of registrants to ascertain compliance with the provisions of the rules issued thereunder regarding radiological working conditions. The rules in this Section apply to all persons who receive, possess, use, own, or transfer sources of radiation registered with agency pursuant to Sections 5. and 11. of this rule.
13.2. Posting of Notices to Workers.
13.2.a. Each registrant shall post current copies of the following documents:
13.2.a.1. The rules in this Section and in Section 6. of this rule;
13.2.a.2. Certificate of registration, conditions or documents incorporated into the registration by reference and amendments thereto;
13.2.a.3. The operating procedures applicable to activities under the registration; and
13.2.a.4. Any notice of violation involving radiological working conditions, proposed imposition of civil penalty, or order issued pursuant to Section 1 of this rule, and any response from the registrant.
13.2.b. If posting of a document specified in Paragraph 13.11.a.1., 2., or 3. is not practicable, the registrant may post a notice which describes the document and states where it may be examined.
13.2.c. Agency Form X "notice to employees" shall be posted by each registrant as required by this rule.
13.2.d. Agency documents posted pursuant to Paragraph 13.11.a.4. shall be posted within five (5) working days after receipt of the documents from the agency; the registrant's response, if any, shall be posted within five (5) working days after dispatch from the registrant. Such documents shall remain posted for a minimum of five (5) working days or until action correcting the violation has been completed, whichever is later.
13.2.e. Documents, notices, or forms posted pursuant to Subsection 13.11. shall appear in a sufficient number of places to permit individuals engaged in work under the registration to observe them on the way to or from any particular work location to which the document applies, shall be conspicuous, and shall be replaced if defaced or altered.
13.3. Instructions to Workers.
13.3.a. All individuals likely to receive an occupational dose:
13.3.a.1. Shall be kept informed of the storage, transfer, or use of sources of radiation in the registrant's workplace;
13.3.a.2. Shall be instructed in the health protection problems associated with exposure to radiation or radioactive material to the individual and potential offspring, in precautions or procedures to minimize exposure, and in the purposes and functions of protective devices employed;
13.3.a.3. Shall be instructed in, and instructed to observe, to the extent within the worker's control, the applicable provisions of this rule for the protection of personnel from exposures to radiation or radioactive material;
13.3.a.4. Shall be instructed of their responsibility to report promptly to the registrant any condition which may constitute, lead to, or cause a violation of the act, this rule, or any unnecessary exposure to radiation or radioactive material;
13.3.a.5. Shall be instructed in the appropriate response to warnings made in the event of any unusual occurrence or malfunction that may involve exposure to radiation or radioactive material; and
13.3.a.6. Shall be advised as to the radiation exposure reports which workers shall be furnished pursuant to Subsection 13.13.
13.3.b. The extent of these instructions shall be commensurate with potential radiological health protection problems present in the workplace.
13.4. Notifications and Reports to Individuals.
13.4.a. Radiation exposure data for an individual and the results of any measurements, analyses, and calculations of radioactive material deposited or retained in the body of an individual shall be reported to the individual as specified in Subsection 13.13. The information reported shall include data and results obtained pursuant to this rule as shown in records maintained by the registrant pursuant to Subsection 6.46. of this rule. Each notification and report shall:
13.4.a.1. Be in writing;
13.4.a.2. Include appropriate identifying data such as the name of the registrant, the name of the individual, and the individual's identification number, preferably social security number;
13.4.a.3. Include the individual's exposure information; and
13.4.a.4. Contain the following statement: "This report is furnished to you under the provisions of Section 13. You should preserve this report for further reference."
13.4.b. Each registrant shall furnish to each worker annually a written report of the worker's dose as shown in records maintained by the registrant or registrant pursuant to Subsection 6.46. of this rule.
13.4.c. Each registrant shall furnish a written report of the worker's exposure to sources of radiation at the request of a worker formerly engaged in activities controlled by the registrant. The report shall include the dose record for each year the worker was required to be monitored pursuant to Subdivision 13.4.a. of this rule. Such report shall be furnished within thirty (30) days from the date of the request, or within thirty (30) days after the dose of the individual has been determined by the registrant, whichever is later. The report shall cover the period of time that the worker's activities involved exposure to sources of radiation and shall include the dates and locations of work under the registration in which the worker participated during this period.
13.4.d. When a registrant is required pursuant to Subsection 6.53., 6.54., or 6.55. of this rule to report to the agency any exposure of an individual to sources of radiation, the registrant shall also provide the individual a written report on the exposure data included therein. Such reports shall be transmitted at a time not later than the transmittal to the agency.
13.4.e. At the request of a worker who is terminating employment with the registrant in work involving exposure to radiation or radioactive material, during the current year, each registrant shall provide at termination to each such worker, or to the worker's designee, a written report regarding the radiation dose received by that worker from operations of the registrant during the current year or fraction thereof. If the most recent individual monitoring results are not available at that time, a written estimate of the dose shall be provided together with a clear indication that this is an estimate.
13.5. Presence of Representatives of Registrants and Workers During Inspection.
13.5.a. Each registrant shall afford to the agency at all reasonable times opportunity to inspect materials, machines, activities, facilities, premises, and records pursuant to this rule.
13.5.b. During an inspection, agency inspectors may consult privately with workers as specified in Subsection 13.15. The registrant may accompany agency inspectors during other phases of an inspection.
13.5.c. If, at the time of inspection, an individual has been authorized by the workers to represent them during agency inspections, the registrant shall notify the inspectors of such authorization and shall give the workers' representative an opportunity to accompany the inspectors during the inspection of physical working conditions.
13.5.d. Each workers' representative shall be routinely engaged in work under control of the registrant and shall have received instructions as specified in Subsection 13.12.
13.5.e. Different representatives of registrants and workers may accompany the inspectors during different phases of an inspection if there is no resulting interference with the conduct of the inspection. However, only one workers' representative at a time may accompany the inspectors.
13.5.f. With the approval of the registrant or registrant and the workers' representative, an individual who is not routinely engaged in work under control of the registrant, for example, a consultant to the registrant or to the workers' representative, shall be afforded the opportunity to accompany agency inspectors during the inspection of physical working conditions.
13.5.g. Notwithstanding the other provisions of Subsection 13.14., agency inspectors are authorized to refuse to permit accompaniment by any individual who deliberately interferes with a fair and orderly inspection. With regard to areas containing information classified by an agency of the U.S. government in the interest of national security, an individual who accompanies an inspector may have access to such information only if authorized to do so. With regard to any area containing proprietary information, the workers' representative for that area shall be an individual previously authorized by the registrant or registrant to enter that area.
13.6. Consultation With Workers During Inspections.
13.6.a. Agency inspectors may consult privately with workers concerning matters of occupational radiation protection and other matters related to applicable provisions of this rule to the extent the inspectors deem necessary for the conduct of an effective and thorough inspection.
13.6.b. During the course of an inspection, any worker may bring privately to the attention of the inspectors, either orally or in writing, any past or present condition which the worker has reason to believe may have contributed to or caused any violation of the this rule or any unnecessary exposure of an individual to sources of radiation under the registrant 's or registrant's control. Any such notice in writing shall comply with the requirements of Subdivision 13.6.a.
13.6.c. The provisions of Subdivision 13.15.b. shall not be interpreted as authorization to disregard instructions pursuant to Subsection 13.12.
13.7. Requests by Workers for Inspections.
13.7.a. Any worker or representative of workers believing that a violation of this rule exists or has occurred in work under a registration with regard to radiological working conditions in which the worker is engaged may request an inspection by giving notice of the alleged violation to the WV Radiation Control Program. Any such notice shall be in writing, shall set forth the specific grounds for the notice, and shall be signed by the worker or representative of the workers. A copy shall be provided to the registrant or registrant by the WV Radiation Control Program no later than at the time of inspection except that, upon the request of the worker giving such notice, such worker's name and the name of individuals referred to therein shall not appear in such copy or on any record published, released, or made available by the agency, except for good cause shown.
13.7.b. If, upon receipt of such notice, the WV Radiation Control Program determines that the complaint meets the requirements set forth in Subdivision 13.16.a., and that there are reasonable grounds to believe that the alleged violation exists or has occurred, an inspection shall be made as soon as practicable to determine if such alleged violation exists or has occurred. Inspections pursuant to Subsection 13.16. need not be limited to matters referred to in the complaint.
13.7.c. No registrant, or contractor or subcontractor of a registrant shall discharge or in any manner discriminate against any worker because such worker has filed any complaint or instituted or caused to be instituted any proceeding under this rule or has testified or is about to testify in any such proceeding or because of the exercise by such worker on behalf of such worker or others of any option afforded by this Section.
13.8. Inspections Not Warranted; Informal Review.
13.8.a. If the WV Radiation Control Program determines, with respect to a complaint under Subsection 13.16., that an inspection is not warranted because there are no reasonable grounds to believe that a violation exists or has occurred, the WV Radiation Control Program shall notify the complainant in writing of such determination. The complainant may obtain review of such determination by submitting a written statement of position with the WV Office of Environmental Health Services. Such agency will provide the registrant with a copy of such statement by certified mail, excluding, at the request of the complainant, the name of the complainant. The registrant may submit an opposing written statement of position with the WV Office of Environmental Health Services. Such agency will provide the complainant with a copy of such statement by certified mail.
13.8.b. Upon the request of the complainant, the WV Office of Environmental Health Services may hold an informal conference in which the complainant and the registrant may orally present their views. An informal conference may also be held at the request of the registrant or registrant, but disclosure of the identity of the complainant will be made only following receipt of written authorization from the complainant. After considering all written and oral views presented, the WV Office of Environmental Health Services shall affirm, modify, or reverse the determination of the WV Radiation Control Program and furnish the complainant and the registrant a written notification of the decision and the reason therefor.
13.8.c. If the WV Radiation Control Program determines that an inspection is not warranted because the requirements of Subdivision 13.16.a. have not been met, the complainant shall be notified in writing of such determination. Such determination shall be without prejudice to the filing of a new complaint meeting the requirements of Subdivision 13.16.a.
W. Va. Code R. § 64-23-14 Transportation of Radioactive Material
14.1. Purpose and Scope. The rules in this Section establish requirements for packaging, preparation for shipment, and transportation of radioactive material and apply to any person who transports radioactive material or delivers radioactive material to a carrier for transport.
14.2. Definitions. As used in this Section, the following definitions apply:
14.2.a. Carrier - a person engaged in the transportation of passengers or property by land or water as a common, contract, or private carrier, or by civil aircraft.
14.2.b. Closed Transport Vehicle - a transport vehicle equipped with a securely attached exterior enclosure that during normal transportation restricts the access of unauthorized persons to the cargo space containing the radioactive material. The enclosure may be either temporary or permanent but shall limit access from top, sides, and ends. In the case of packaged materials, it may be of the "see-through" type.
14.2.c. Exclusive use - the sole use of a conveyance by a single consignor and for which all initial, intermediate, and final loading and unloading are carried out in accordance with the direction of the consignor or consignee.12
14.2.d. Fissile material - any special nuclear material consisting of or containing one or more fissile radionuclides. Fissile radionuclides are Plutonium-238, Plutonium-239, Plutonium-241, Uranium-233, and Uranium-235. Neither natural nor depleted uranium is fissile material.13
14.2.d.1. Fissile Class I: A package which may be transported in unlimited numbers and in any arrangement, and which requires no nuclear criticality safety controls during transportation. A transport index is not assigned for purposes of nuclear criticality safety but may be required because of external radiation levels.
14.2.d.2. Fissile Class II: A package which may be transported together with other packages in any arrangement but, for criticality control, in numbers which do not exceed an aggregate transport index of fifty (50). These shipments require no other nuclear criticality safety control during transportation. Individual packages may have a transport index not less than one-tenth (0.1) and not more than ten (10).
14.2.e. Low specific activity material - any of the following:
14.2.e.1. Uranium or thorium ores and physical or chemical concentrates of those ores;
14.2.e.2. Unirradiated natural or depleted uranium or unirradiated natural thorium;
14.2.e.3. Tritium oxide in aqueous solutions provided the concentration does not exceed five (5.0) millicuries (one hundred eighty five [185] MBq) per milliliter;
14.2.e.4. Material in which the radioactivity is essentially uniformly distributed and in which the estimated average concentration per gram of contents does not exceed:
14.2.e.4.A. One ten-thousandth (0.0001) millicurie (three and seven-tenths [3.7] kBq) of radionuclides for which the A2 quantity in Table 64-23 Ee is not more than five one-hundredths (0.05) curie (one and eighty five one-hundredths [1.85] GBq);
14.2.e.4.B. One five-thousandth (0.005) millicurie (one hundred eighty five [185] kBq) of radionuclides for which the A2 quantity in Table 64-23 Ee is more than five one-hundredths (0.05) curie (one and eighty five one-thousandths [1.85] GBq) but not more than one (1) curie (thirty seven [37] GBq); or
14.2.e.4.C. Three-tenths (0.3) millicurie (eleven and one-tenth [11.1] MBq) of radionuclides for which the A2 quantity in Table 64-23 Ee is more than one (1) curie (thirty seven [37] GBq).
14.2.f. Objects of nonradioactive material externally contaminated with radioactive material, provided that the radioactive material is not readily dispersible, and the surface contamination, when averaged over an area of one (1) square meter, does not exceed one ten-thousandths (0.0001) millicurie per square centimeter (three and seven-tenths [3.7] kBq/cm2) of radionuclides for which the A2 quantity in Table 64-23 Ee not more than five one-hundredths (0.05) curie (one and eight five one-hundredths [1.85] GBq) or one one-thousandth (0.001) millicurie per square centimeter (thirty seven [37] kBq/cm2) for other radionuclides.
14.2.g. Normal Form Radioactive Material - radioactive material which has not been demonstrated to qualify as special form radioactive material.
14.2.h. Packaging - the assembly of components necessary to ensure compliance with the packaging requirements of this Section. It may consist of one or more receptacles, absorbent materials, spacing structures, thermal insulation, radiation shielding, and devices for cooling or absorbing mechanical shocks. The vehicle, tie-down system, and auxiliary equipment may be designated as part of the packaging.
14.2.i. Rules of the U.S. Department of Transportation - the rules in 49 CFR Parts 100-189.
14.2.j. Specific Activity - of a radionuclide is the radioactivity of a radionuclide per unit mass of that nuclide. The specific activity of a material in which the radionuclide is essentially uniformly distributed is the radioactivity per unit mass of the material.
14.2.k. Transport Index - the dimensionless number, rounded up to the first decimal place, placed on the label of a package to designate the degree of control to be exercised by the carrier during transportation. The transport index is the number expressing the maximum radiation level in millirem per hour at one (1) meter from the external surface of the package.
14.2.l. Type A Quantity - a quantity of radioactive material, the aggregate radioactivity of which does not exceed A1 for special form radioactive material or A2 for normal form radioactive material, where A1 and A2 are given in Table 64-23 Ee or may be determined by procedures described in Table 64-23 Ee.
14.2.m. Type B Package - a Type B packaging together with its radioactive contents.
14.2.n. Type B Packaging - a packaging designed to retain the integrity of containment and shielding when subjected to the normal conditions of transport and hypothetical accident test conditions set forth in 10 CFR Part 71.
14.2.o. Type B Quantity - a quantity of radioactive material greater than a Type A quantity.
14.3. Requirement for Registration. No person shall transport radioactive material or deliver radioactive material to a carrier for transport except as authorized in a general or specific registration issued by the agency or as exempted in Subsection 14.4.
14.4. Exemptions
14.4.a. Common and contract carriers, freight forwarders, and warehousemen which are subject to the requirements of the U.S. Department of Transportation (DOT) in 49 CFR 170 through 189 or the U.S. Postal Service in the Postal Service Manual (Domestic Mail Manual), Section 124.3 incorporated by reference, 39 CFR 111.11 (1974), and the U.S. Postal Service are exempt from the requirements of this Section to the extent that they transport or store radioactive material in the regular course of their carriage for others or storage incident thereto. Common and contract carriers who are not subject to the requirements of the DOT or U.S. Postal Service are subject to Subsection 14.3. and other applicable requirements of this rule.
14.4.b. Any registrant is exempt from the requirements of this Section to the extent that the registrant delivers to a carrier for transport a package containing radioactive material having a specific activity not greater than two one-thousandths (0.002) microcurie per gram (seventy four [74] Bq/gm).
14.4.c. With the exception of Subsections 14.5. and 14.16., a registrant is exempt from all requirements of this Section, with respect to shipment or carriage of the following:
14.4.c.1. A package containing no more than a Type A quantity of radioactive material if the package contains no fissile material; or
14.4.c.2. Packages transported between locations within the United States which contain only americium or plutonium in special form with an aggregate radioactivity not to exceed twenty (20) curies (seven hundred forty [740] GBq).
14.5. Transportation of Registered Material
14.5.a. Each registrant who transports registered material outside of the confines of the registrant’s plant or other place of use, or who delivers registered material to a carrier for transport, shall:
14.5.a.1. Comply with the applicable requirements, appropriate to the mode of transportation, of the regulations of DOT; and
14.5.a.2. Assure that any special instructions needed to safely open the package are sent to or have been made available to the consignee.
14.5.b. If, for any reason, the regulations of the DOT are not applicable to a shipment of registered material, the registrant shall conform to the standards and requirements of those regulations to the same extent as if the shipment was subject to the regulations.
14.6. General Registration for Carriers
14.6.a. A general registration is hereby issued to any common or contract carrier not exempt under Subsection 14.4. to receive, possess, transport, and store radioactive material in the regular course of their carriage for others or storage incident thereto, provided the transportation and storage is in accordance with the applicable requirements, appropriate to the mode of transport, of the DOT insofar as such requirements relate to the loading and storage of packages, placarding of the transporting vehicle, and incident reporting.14
14.6.b. A general registration is hereby issued to any private carrier to transport radioactive material, provided the transportation is in accordance with the applicable requirements, appropriate to the mode of transport, of the DOT insofar as such requirements relate to the loading and storage of packages, placarding of the transporting vehicle, and incident report.4
14.6.c. Persons who transport radioactive material pursuant to the general registration in Subdivision 14.6.a. or b. are exempt from the requirements of Sections 6. and 13. of this rule to the extent that they transport radioactive material.
14.7. General Registration: Approved Packages
14.7.a. A general registration is hereby issued to any registrant of the agency to transport, or to deliver to a carrier for transport, registered material in a package for which a registration, certificate of compliance, or other approval has been issued by the U.S. Nuclear Regulatory Commission.
14.7.b. This general registration applies only to a registrant who:
14.7.b.1. Has a copy of the specific registration, certificate of compliance, or other approval of the certificate of compliance, or other approval has been issued by the U.S. Nuclear Regulatory Commission.
14.7.b. This general registration applies only to a registrant who:
14.7.b.2. Complies with the terms and conditions of the rules, as applicable, and the applicable requirements of this Section;
14.7.b.3. Prior to the registrant's first use of the package, has registered with the NRC; and
14.7.b.4. Has a quality assurance program required by Subsection 14.20. and approved by
14.7.c. The general registration in Subdivision 14.7.a. applies only when the package approval authorizes use of the package under this general registration.
14.7.d. For previously approved Type B packages which are not designated as either B(U) or B(M) in the certificate of compliance, this general registration is subject to additional restrictions of Subsection 14.8.
14.8. General Registration: Previously Approved Type B Packages
14.8.a. A Type B package previously approved by the NRC, but not designated as B(U) or B(M) in the certificate of compliance, may be used under the general registration of Subsection 14.7. with the following additional limitations:
14.8.a.1. Fabrication of the packaging was satisfactorily completed before August 31, 1986, as demonstrated by application of its model number in accordance with NRC rules; and package issued by the U.S. Nuclear Regulatory Commission and has the drawings and other documents referenced in the approval relating to the use and maintenance of the packaging and to the actions to be taken prior to shipment;
14.8.a.2. The package may not be used for a shipment to a location outside the United States after August 31, 1986, except approved under special arrangement in accordance with 49 CFR 173.471.
14.9. General Registration: Specification Container
14.9.a. A general registration is issued to any registrant of the agency to transport, or to deliver to a carrier for transport, registered material in a specification container for a Type B quantity of radioactive material as specified in 49 CFR parts 173 and 178.
14.9.b. This general registration applies only to a registrant who has a quality assurance program required by Subsection 14.20. and approved by the agency.
14.9.c. This general registration applies only to a registrant who:
14.9.c.1. Has a copy of the specification; and
14.9.c.2. Complies with the terms and conditions of the specification and the applicable requirements of this Section.
14.9.d. The general registration in Subdivision 14.9.a. is subject to the limitation that the specification container may not be used for a shipment to a location outside the United States after August 31, 1986 except approved under special arrangements in accordance with 49 CFR 173.472.
14.10. General Registration: Type A, Fissile Class II Package
14.10.a. A general registration is hereby issued to any registrant to transport fissile material, or to deliver fissile material to a carrier for transport, if the material is shipped as a fissile Class II package.
14.10.b. This general registration applies only when a package contains no more than a Type A quantity of radioactive material, including only one of the following:
14.10.b.1. Up to 40 grams of Uranium-235; or
14.10.b.2. Up to 30 grams of Uranium-233; or
14.10.b.3. Up to 25 grams of the fissile radionuclides of plutonium, except that for encapsulated plutonium-beryllium neutron sources in special form, an A1 quantity of plutonium may be present; or
14.10.b.4. A combination of fissile radionuclides in which the sum of the ratios of the amount of each radionuclide to the corresponding maximum amounts in
14.10.c. Except as specified in Subdivision 13.10.d., this general registration applies only when a package containing more than fifteen (15) grams of fissile radionuclides is labeled with a transport index not less than the number given by the following equation:
Minimum Transport Index = (0.4x + 0.67y + z) (1 - 15) x+y+z where the package contains x grams of Uranium-235, y grams of Uranium-233, and z grams of the fissile radionuclides of plutonium.
14.10.d. For a package in which the only fissile material is in the form of encapsulated plutonium-beryllium neutron sources in special form, the transport index based on criticality considerations may be taken as twenty six one-thousandths (0.026) times the number of grams of the fissile radionuclides of plutonium in excess of fifteen (15) grams.
14.10.e. In all cases, the transport index must be rounded up to one decimal place and may not exceed ten (10.0).
14.11. General Registration: Restricted, Fissile Class II Package
14.11.a. A general registration is hereby issued to any registrant to transport fissile material, or to deliver fissile material to a carrier for transport, if the material is shipped as a fissile class II package.
14.11.b. This general registration applies only when all of the following requirements are met.
14.11.b.1. The package contains no more than a Type A quantity of radioactive material. 14.11b.2. Neither beryllium nor hydrogenous material enriched in deuterium is present.
14.11.b.3. The total mass of graphite present does not exceed one hundred fifty (150) times the total mass of Uranium-235 plus plutonium.
14.11.b.4. Substances having a higher hydrogen density than water are not present, except that polyethylene may be used for packing or wrapping.
14.11.b.5. Uranium-233 is not present, and the amount of plutonium does not exceed 1 percent of the amount of Uranium-235.
14.11.b.6. The amount of Uranium-235 is limited as follows:
14.11.b.6.A. If the fissile radionuclides are not uniformly distributed, the maximum amount of Uranium-235 per package may not exceed the value given in the Table 64-23 Bb.
14.11.b.6.B. If the fissile radionuclides are distributed uniformly, the maximum amount of Uranium-235 per package may not exceed the value given in the Table 64-23 Cc.
14.11.b.7. The transport index of each package based on criticality considerations is taken as 10 times the number of grams of Uranium-235 in the package divided by the maximum allowable number of grams per package in accordance with Tables 64-23 Bb and Cc as applicable.
14.12. Operating Controls and Procedures
14.12.a. Fissile material: assumptions as to unknown properties. When the isotopic abundance, mass, concentration, degree of irradiation, degree of moderation, or other pertinent property of fissile material in any package is not known, the registrant shall package the fissile material as if the unknown properties had credible values that would cause the maximum nuclear reactivity.
14.12.b. Preliminary Determinations. Prior to the first use of any packaging for the shipment of radioactive material:
14.12.b.1. The registrant shall ascertain that there are no defects which could significantly reduce the effectiveness of the packaging;
14.12.b.2. Where the maximum normal operating pressure will exceed thirty four and three-tenths (34.3) kilopascal (five [5] psi) gauge, the registrant shall test the containment system at an internal pressure at least fifty (50) percent higher than the maximum normal operating pressure to verify the capability of that system to maintain its structural integrity at that pressure;
14.12.b.3. The registrant shall determine that the packaging has been fabricated in accordance with the design approved by the NRC; and
14.12.b.4. The registrant shall conspicuously and durably mark the packaging with its model number, gross weight, and a package identification number assigned by the NRC.
14.13. Routine Determinations. Prior to each shipment of registered material, the registrant shall determine that:
14.13.a. The package is proper for the contents to be shipped;
14.13.b. The package is in unimpaired physical condition except for superficial defects such as marks or dents;
14.13.c. Each closure device of the packaging, including any required gasket, is properly installed and secured and free of defects;
14.13.d. Any system for containing liquid is adequately sealed and has adequate space or other specified provision for expansion of the liquid;
14.13.e. Any pressure relief device is operable and set in accordance with written procedures;
14.13.f. The package has been loaded and closed in accordance with written procedures;
14.13.g. Any structural part of the package which could be used to lift or tie down the package during transport is rendered inoperable for that purpose unless it satisfies design five (5) requirements specified by the NRC;
14.13.h. The level of removable radioactive contamination on the external surfaces of each package offered for shipment is as low as reasonably achievable. The level of removable radioactive contamination may be determined by wiping an area of three hundred (300) square centimeters of the surface concerned with an absorbent material, using moderate pressure, and measuring the activity on the wiping material. Sufficient measurements must be taken in the most appropriate locations to yield a representative assessment of the removable contamination levels. Except as provided in Subdivision 14.13.i., the amount of radioactivity measured on any single wiping material, when averaged over the surface wiped, must not exceed the limits given in Table 64-23 Dd at any time during transport. Other methods of assessment of equal or greater efficiency may be used. When other methods are used, the detection efficiency of the method used must be taken into account and in no case may the removable contamination on the external surfaces of the package exceed ten (10) times the limits listed in Table 64-23 Dd.
14.13.i. In the case of packages transported as exclusive use shipments by rail or highway only, the removable radioactive contamination at any time during transport must not exceed ten (10) times the levels prescribed in Subdivision 14.13.h. The levels at the beginning of transport must not exceed the levels in Subdivision 14.13.h.;
14.13.j. External radiation levels around the package and around the vehicle, if applicable, will not exceed two hundred (200) millirems per hour (two [2] mSv/h) at any point on the external surface of the package at any time during transportation. The transport index shall not exceed ten (10);
14.13.k. For a package transported in exclusive use by rail, highway or water, radiation levels external to the package may exceed the limits specified in Subsection 13.14.j. but shall not exceed any of the following:
14.13.k.1. Two hundred (200) millirems per hour (two [2] mSv/h) on the accessible external surface of the package unless the following conditions are met, in which case the limit is one thousand (1000) millirems per hour (ten [10] mSv/h);
14.13.k.1.A. The shipment is made in a closed transport vehicle,
14.13.k.1.B. Provisions are made to secure the package so that its position within the vehicle remains fixed during transportation, and
14.13.k.1.C. There are no loading or unloading operations between the beginning and end of the transportation.
14.13.k.2. Two hundred (200) millirems per hour (two [2] mSv/h) at any point on the outer surface of the vehicle, including the upper and lower surfaces, or, in the case of a flat-bed style vehicle, with a personnel barrier15, at any point on the vertical planes projected from the outer edges of the vehicle, on the upper surface of the load [or enclosure, if used], and on the lower external surface of the vehicle;
14.13.k.3. Ten (10) millirems per hour (one-tenth [0.1] mSv/h) at any point two (2) meters from the vertical planes represented by the outer lateral surfaces of the vehicle, or, in the case of a flat-bed style vehicle, at any point two (2) meters from the vertical planes projected from the outer edges of the vehicle; and
14.13.k.4. Two (2) millirems per hour (two one-hundredths [0.02 ]mSv/h) in any normally occupied positions of the vehicle, except that this provision does not apply to private motor carriers when persons occupying these positions are provided with special health supervision, personnel radiation exposure monitoring devices, and training in accordance with Subsection 13.12. of this rule.
14.13.l. A package must be prepared for transport so that in still air at one hundred (100) degrees Fahrenheit (thirty eight [38] degrees Celsius) and in the shade, no accessible surface of a package would have a temperature exceeding one hundred twenty two (122) degrees Fahrenheit (fifty [50] degrees Celsius) in a nonexclusive use shipment or one hundred eighty (180) degrees Fahrenheit (eighty two [82] degrees Celsius) in an exclusive use shipment. Accessible package surface temperatures shall not exceed these limits at any time during transportation.
14.14. Air Transport of Plutonium. Notwithstanding the provisions of any general registration and notwithstanding any exemptions stated directly in this Section or included indirectly by citation of the DOT regulations, as may be applicable, the registrant shall assure that plutonium in any form is not transported by air, or delivered to a carrier for air transport, unless:
14.14.a. The plutonium is contained in a medical device designed for individual human application; or
14.14.b. The plutonium is contained in a material in which the specific activity is not greater than two one-thousandths (0.002) microcuries per gram (seventy four [74] Bq/gm) of material and in which the radioactivity is essentially uniformly distributed; or
14.14.c. The plutonium is shipped in a single package containing no more than an A2 quantity of plutonium in any isotope or form and is shipped in accordance with Subsection 14.5.; or
14.14.d. The plutonium is shipped in a package specifically authorized for the shipment of plutonium by air in the certificate of compliance for that package issued by the NRC.
14.15. Shipment Records. Each registrant shall maintain for a period of two (2) years after shipment a record of each shipment of registered material not exempt under Subsection 14., showing, where applicable:
14.15.a. Identification of the packaging by model number;
14.15.b. Verification that there were no significant defects in the packaging, as shipped;
14.15.c. Volume and identification of coolant;
14.15.d. Type and quantity of registered material in each package, and the total quantity of each shipment;
14.15.e. Date of the shipment;
14.15.f. Name and address of the transferee;
14.15.g. Address to which the shipment was made; and
14.15.h. Results of the determinations required by Subsection 14.13.
14.16. Reports. The registrant or registrant shall report to the agency within thirty (30) days:
14.16.a. Any instance in which there is significant reduction in the effectiveness of any authorized packaging during use; and
14.16.b. Details of any defects with safety significance in the packaging after first use, with the means employed to repair the defects and prevent their recurrence.
14.17. Advance Notification of Transport of Nuclear Waste
14.17.a. Prior to the transport of any nuclear waste outside of the confines of the registrant’s facility or other place of use or storage, or prior to the delivery of any nuclear waste to a carrier for transport, each registrant shall provide advance notification of such transport to the governor, or governor's designee, of each state through which the waste will be transported.
14.17.b. Advance notification is required only when:
14.17.b.1. The nuclear waste is required to be in Type B packaging for transportation;
14.17.b.2. The nuclear waste is being transported to, through, or across state boundaries to a disposal site or to a collection point for transport to a disposal site; and
14.17.b.3. The quantity of registered material in a single package exceeds;
14.17.b.3.A. Five thousand (5,000) curies (one hundred eighty five [185] TBq) of special form radionuclides;
14.17.b.3.B. Five thousand (5,000) curies (one hundred eighty five [185] TBq) of uncompressed gases of argon-41, Krypton-85m, Krypton-87, Xenon-131m, or Xenon-135;
14.17.b.3.C. Fifty thousand (50,000) curies (one and eighty five [1.85] PBq) of argon-37, or of uncompressed gases of Krypton-85 or Xenon-133, or of Hydrogen-3 as a gas, as luminous paint, or absorbed on solid material;
14.17.b.3.D. Twenty (20) curies (seven hundred forty [740] GBq) of other non-special form radionuclides for which A2 is less than or equal to four (4) curies (one hundred forty eight [148] GBq); or
14.17.b.3.E. Two hundred (200) curies (seven and four-tenths [7.4] TBq) of other non-special form radionuclides for which A2 is greater than four (4) curies (one hundred forty eight [148] Gbq).
14.17.c. Each advance notification required by Subdivision 14.18.a. shall contain the following information:
14.17.c.1. The name, address, and telephone number of the shipper, carrier, and receiver of the shipment;
14.17.c.2. A description of the nuclear waste contained in the shipment as required by 49 CFR 172.202 and 172.203(d);
14.17.c.3. The point of origin of the shipment and the seven-day period during which departure of the shipment is estimated to occur;
14.17.c.4. The seven-day period during which arrival of the shipment at state boundaries is estimated to occur;
14.17.c.5. The destination of the shipment, and the seven-day period during which arrival of the shipment is estimated to occur; and
14.17.c.6. A point of contact with a telephone number for current shipment information.
14.17.d. The notification required by Subdivision 14.17.a. shall be made in writing to the office of each appropriate governor, or governor's designee, and to the agency. A notification delivered by mail must be postmarked at least seven days before the beginning of the seven-day period during which departure of the shipment is estimated to occur. A notification delivered by messenger must reach the office of the governor, or governor's designee, at least four days before the beginning of the seven-day period during which departure of the shipment is estimated to occur. A copy of the notification shall be retained by the registrant for one (1) year.
14.17.e. The registrant shall notify each appropriate governor, or governor's designee, and the agency of any changes to schedule information provided pursuant to Subdivision 14.18.a. Such notification shall be by telephone to a responsible individual in the office of the governor, or governor's designee, of the appropriate state or states. The registrant shall maintain for one (1) year a record of the name of the individual contacted.
14.17.f. Each registrant who cancels a nuclear waste shipment, for which advance notification has been sent, shall send a cancellation notice to the governor, or governor's designee, of each appropriate state and to the agency. A copy of the notice shall be retained by the registrant for one (1) year.
14.18. Quality Assurance Requirements
14.18.a. Each registrant shall establish, maintain, and execute a quality assurance program to verify by procedures such as checking, auditing, and inspection that deficiencies, deviations, and defective material and equipment relating to the shipment of packages containing radioactive material are promptly identified and corrected.
14.18.b. The registrant shall identify the material and components to be covered by the quality assurance program.
14.18.c. Each registrant shall document the quality assurance program by written procedures or instructions and shall carry out the program in accordance with those procedures throughout the period during which packaging is used.
14.18.d. Prior to the use of any package for the shipment of radioactive material, each registrant shall obtain approval by the agency of its quality assurance program.
14.18.e. The registrant shall maintain sufficient written records to demonstrate compliance with the quality assurance program. Records of quality assurance pertaining to the use of a package for shipment of radioactive material shall be maintained for a period of two years after shipment.
W. Va. Code R. § 64-23-15 Radiation Safety Requirements for Wireline Services Operations and Subsurface Tracer Studies
15.1. Purpose. The rules in this Section establish radiation safety requirements for using sources of radiation for wireline service operations including mineral-logging, radioactive markers, and subsurface tracer studies. The requirements of this Section are in addition to, and not in substitution for, the requirements of Sections 1., 5., 6., 11., and 13. of this rule.
15.2. Scope. The rules in this Section apply to all registrants who use sources of radiation for wireline service operations including mineral-logging, radioactive markers, or subsurface tracer studies.
15.3. Definitions. As used in this Section, the following definitions apply:
15.3.a. Field station - a facility where radioactive sources may be stored or used and from which equipment is dispatched to temporary Job sites.
15.3.b. Injection Tool - a device used for controlled subsurface injection of radioactive tracer material.
15.3.c. Logging assistant - any individual who, under the personal supervision of a logging supervisor, handles sealed sources or tracers that are not in logging tools or shipping containers or who performs surveys required by Subsection 15.20.
15.3.d. Logging Supervisor - the individual who uses sources of radiation or provides personal supervision of the utilization of sources of radiation at the well site.
15.3.e. Logging Tool - a device used subsurface to perform well-logging.
15.3.f. Mineral Logging - any logging performed for the purpose of mineral exploration other than oil or gas.
15.3.g. Personal Supervision - guidance and instruction by the supervisor who is physically present at the jobsite and watching the performance of the operation in such proximity that contact can be maintained and immediate assistance given as required.
15.3.h. Radioactive Marker - radioactive material placed subsurface or on a structure intended for subsurface use for the purpose of depth determination or direction orientation.
15.3.i. Source Holder - a housing or assembly into which a radioactive source is placed for the purpose of facilitating the handling and use of the source in well-logging operations.
15.3.j. Subsurface Tracer Study - the release of a substance tagged with radioactive material for the purpose of tracing the movement or position of the tagged substance in the well-bore or adjacent formation.
15.3.k. Temporary Jobsite - a location where radioactive materials are present for the purpose of performing wireline service operations or subsurface tracer studies.
15.3.l. Uranium Sinker Bar - a weight containing depleted uranium used to pull a logging tool down toward the bottom of a well.
15.3.m. Well-bore - a drilled hole in which wireline service operations or subsurface tracer studies are performed.
15.3.n. Well-logging - all operations involving the lowering and raising of measuring devices or tools which may contain sources of radiation into well-bores or cavities for the purpose of obtaining information about the well or adjacent formations.
15.3.o. Wireline - a cable containing one or more electrical conductors which is used to lower and raise logging tools in the well-bore.
15.3.p. Wireline Service Operation - any evaluation or mechanical service which is performed in the well-bore using devices on a wireline.
15.4. Prohibition. No registrant shall perform wireline service operations with a sealed source or sealed sources unless, prior to commencement of the operation, the registrant has a written agreement with the well-operator, well-owner, drilling contractor, or land owner that:
15.4.a. In the event a sealed source is lodged downhole, a reasonable effort at recovery will be made; and
15.4.b. In the event a decision is made to abandon the sealed source downhole, the requirements of Subdivision 15.23.c. shall be met.
15.5. Limits on Levels of Radiation. Sources of radiation shall be used, stored, and transported in such a manner that the transportation requirements of Section 15. and the dose limitation requirements of Section 6 of this rule are met.
15.6. Storage Precautions
15.6.a. Each source of radiation, except accelerators, shall be provided with a storage or transport container. The container shall be provided with a lock, or tamper seal for calibration sources, to prevent unauthorized removal of, or exposure to, the source of radiation.
15.6.b. Sources of radiation shall be stored in a manner which will minimize danger from explosion or fire.
15.7. Transport Precautions. Transport containers shall be physically secured to the transporting vehicle to prevent accidental loss, tampering, or unauthorized removal.
15.8. Radiation Survey Instruments
15.8.a. The registrant shall maintain sufficient calibrated and operable radiation survey instruments at each field station to make physical radiation surveys as required by this Section and Subsection 6.5 of this rule. Instrumentation shall be capable of measuring one-tenth (0.1) milliroentgen (twenty five and eight-tenths [25.8] nanocoulombs/kg) per hour through at least fifty (50) milliroentgens (twelve and nine-tenths [12.9] icrocoulombs/kg) per hour. Survey instruments acquired before July 1, 20016 and capable of measuring one-tenth (0.1) milliroentgen (twenty five and eight-tenths [25.8] nanocoulombs/kg) per hour through at least twenty (20) milliroentgens (five and sixteen one-hundredths [5.16] microcoulombs/kg) per hour also satisfies this requirement July 1, 2006.
15.8.b. Each radiation survey instrument shall be calibrated:
15.8.b.1. At intervals not to exceed six (6) months and after each instrument servicing;
15.8.b.2. For linear scale instruments, at two points located approximately one-third (a) and two-thirds (b) of full-scale on each scale; for logarithmic scale instruments, at midrange of each decade, and at two (2) points of at least one decade; and for digital instruments, at appropriate points; and
15.8.b.3. So that accuracy within twenty (20) percent of the true radiation level can be demonstrated on each scale.
15.8.c. Calibration records shall be maintained for a period of two (2) years for inspection by the agency.
15.9. Leak Testing of Sealed Sources
15.9.a. Requirements. Each registrant using sealed sources of radioactive material shall have the sources tested for leakage. Records of leak test results shall be kept in units of microcuries (Bq) and maintained for inspection by the agency for six (6) months after the next required leak test is performed or until transfer or disposal of the sealed source.
15.9.b. Method of Testing. Tests for leakage shall be performed only by persons specifically authorized to perform such tests by the agency, the U.S. Nuclear Regulatory Commission (NRC), an agreement state, or a licensing state. The test sample shall be taken from the surface of the source, source holder, or from the surface of the device in which the source is stored or mounted and on which one might expect contamination to accumulate. The test sample shall be analyzed for radioactive contamination, and the analysis shall be capable of detecting the presence of five one-thousandths (0.005) microcurie (one hundred eighty five [185] Bq) of radioactive material on the test sample.
15.9.c. Interval of Testing. Each sealed source of radioactive material shall be tested at intervals not to exceed six (6) months. In the absence of a certificate from a transferor indicating that a test has been made prior to the transfer, the sealed source shall not be put into use until tested. If, for any reason, it is suspected that a sealed source may be leaking, it shall be removed from service immediately and tested for leakage as soon as practical.
15.9.d. Leaking or Contaminated Sources. If the test reveals the presence of five one-thousandths (0.005) microcurie (one hundred eighty five (185) Bq) or more of leakage or contamination, the registrant shall immediately withdraw the source from use and shall cause it to be decontaminated, repaired, or disposed of in accordance with this rule. A report describing the equipment involved, the test results, and the corrective action taken shall be filed with the agency within five days of receiving the test results.
15.9.e. Exemptions. The following sources are exempted from the periodic leak test requirements of Subdivision 15.9.a. through d.:
15.9.e.1. Hydrogen-3 sources;
15.9.e.2. Sources of radioactive material with a half-life of thirty (30) days or less;
15.9.e.3. Sealed sources of radioactive material in gaseous form;
15.9.e.4. Sources of beta- or gamma-emitting radioactive material with an activity of one hundred (100) microcuries (three and seven-tenths [3.7] MBq) or less; and
15.9.e.5. Sources of alpha-emitting radioactive material with an activity of ten (10) microcuries (thirty seven one-hundredths [0.370] MBq) or less.
15.10. Quarterly Inventory. Each registrant shall conduct a quarterly physical inventory to account for all sources of radiation. Records of inventories shall be maintained for two years from the date of the inventory for inspection by the agency and shall include the quantities and kinds of sources of radiation, the location where sources of radiation are assigned, the date of the inventory, and the name of the individual conducting the inventory.
15.11. Utilization Records. Each registrant shall maintain current records, which shall be kept available for inspection by the agency for two years from the date of the recorded event, showing the following information for each source of radiation:
15.11.a. Make, model number, and a serial number or a description of each source of radiation used;
15.11.b. The identity of the well-logging supervisor or field unit to whom assigned;
15.11.c. Locations where used and dates of use; and
15.11.d. In the case of tracer materials and radioactive markers, the utilization record shall indicate the radionuclide and activity used in a particular well.
15.12. Design, Performance, and Certification Criteria for Sealed Sources Used in Downhole Operations
15.12.a. Each sealed source, except those containing radioactive material in gaseous form, used in downhole operations and manufactured after July 1, 2002 shall be certified by the manufacturer, or other testing organization acceptable to the agency, to meet the following minimum criteria:
15.12.a.1. Be of doubly encapsulated construction;
15.12.a.2. Contain radioactive material whose chemical and physical forms are as insoluble and non-dispersible as practical; and
15.12.a.3. Has been individually pressure tested to at least twenty four thousand six hundred fifty six (24,656) pounds per square inch absolute (one hundred seventy [170] MN/m2) without failure.
15.12.b. For sealed sources, except those containing radioactive material in gaseous form, acquired after July 1, 2002, in the absence of a certificate from a transferor certifying that an individual sealed source meets the requirements of Subsection 15.12., the sealed source shall not be put into use until such determinations and testing have been performed.
15.12.c. Each sealed source, except those containing radioactive material in gaseous form, used in downhole operations after [insert a date two (2) years after the effective date of this rule] shall be certified by the manufacturer, or other testing organization acceptable to the agency, as meeting the sealed source performance requirements for oil well-logging as contained in the American National Standard N43.6, "Classification of Sealed Radioactive Sources," (formerly N542, ANSI/NBS 126) in effect on July 1, 2001.
15.12.d. Certification documents shall be maintained for inspection by the agency for a period of two years after source disposal. If the source is abandoned downhole, the certification documents shall be maintained until the agency authorizes disposition.
15.13. Labeling
15.13.a. Each source, source holder, or logging tool containing radioactive material shall bear a durable, legible, and clearly visible marking or label, which has, as a minimum, the standard radiation caution symbol, without the conventional color requirement, and the following wording:
DANGER16
RADIOACTIVE
This labeling shall be on the smallest component transported as a separate piece of equipment.
15.13.b. Each transport container shall have permanently attached to it a durable, legible, and clearly visible label which has, as a minimum, the standard radiation caution symbol and the following wording:
DANGER17
RADIOACTIVE
NOTIFY CIVIL AUTHORITIES [OR NAME OF COMPANY]
15.14. Inspection and Maintenance
15.14.a. Each registrant shall conduct, at intervals not to exceed six months, a program of inspection and maintenance of source holders, logging tools, source handling tools, storage containers, transport containers, and injection tools to assure proper labeling and physical condition. Records of inspection and maintenance shall be maintained for a period of two years for inspection by the agency.
15.14.b. If any inspection conducted pursuant to Subdivision 15.14.a. reveals damage to labeling or components critical to radiation safety, the device shall be removed from service until repairs have been made.
15.14.c. If a sealed source is stuck in the source holder, the registrant shall not perform any operation, such as drilling, cutting, or chiseling, on the source holder unless the registrant is specifically approved by the NRC, an agreement state, or a licensing state to perform this operation.
15.14.d. The repair, opening, or modification of any sealed source shall be performed only by persons specifically authorized to do so by the agency, the NRC, an agreement state or a licensing state.
15.15. Training Requirements
15.15.a. No registrant shall permit any individual to act as a logging supervisor as defined in this Section until such individual has:
15.15.a.1. Received, in a course recognized by the agency, the NRC, an agreement state, or a licensing state, instruction in the subjects outlined in Table 64-23 Ff and demonstrated an understanding thereof;
15.15.a.2. Read and received instruction in the rules contained in this Section and the applicable Sections of Sections 1., 6. and 13. of this rule or their equivalent, conditions of appropriate certificate of registration, and the registrant's operating and emergency procedures, and demonstrated an understanding thereof; and
15.15.a.3. Demonstrated competence to use sources of radiation, related handling tools, and radiation survey instruments which will be used on the job.
15.15.b. No registrant shall permit any individual to assist in the handling of sources of radiation until such individual has:
15.15.b.1. Read or received instruction in the registrant's operating and emergency procedures and demonstrated an understanding thereof; and
15.15.b.2. Demonstrated competence to use, under the personal supervision of the logging supervisor, the sources of radiation, related handling tools, and radiation survey instruments which will be used on the job.
15.15.c. The registrant shall maintain employee training records for inspection by the agency for two years following termination of the individual's employment.
15.16. Operating and Emergency Procedures. The registrant's operating and emergency procedures shall include instructions in at least the following:
15.16.a. Handling and use of sources of radiation to be employed so that no individual is likely to be exposed to radiation doses in excess of the standards established in Section 6. of this rule;
15.16.b. Methods and occasions for conducting radiation surveys;
15.16.c. Methods and occasions for locking and securing sources of radiation;
15.16.d. Personnel monitoring and the use of personnel monitoring equipment;
15.16.e. Transportation to temporary Job sites and field stations, including the packaging and placing of sources of radiation in vehicles, placarding of vehicles, and securing sources of radiation during transportation;
15.16.f. Minimizing exposure of individuals in the event of an accident;
15.16.g. Procedure for notifying proper personnel in the event of an accident;
15.16.h. Maintenance of records;
15.16.i. Use, inspection and maintenance of source holders, logging tools, source handling tools, storage containers, transport containers, and injection tools;
15.16.j. Procedure to be followed in the event a sealed source is lodged downhole;
15.16.k. Procedures to be used for picking up, receiving, and opening packages containing radioactive material;
15.16.l. For the use of tracers, decontamination of the environment, equipment, and personnel;
15.16.m. Maintenance of records generated by logging personnel at temporary job sites;
15.16.n. Notifying proper persons in the event of an accident; and
15.16.o. Actions to be taken if a sealed source is ruptured, including actions to prevent the spread of contamination and minimize inhalation and ingestion of radioactive material and actions to obtain suitable radiation survey instruments as required by Subsection 15.8.
15.17. Personnel Monitoring
15.17.a. No registrant shall permit any individual to act as a logging supervisor or to assist in the handling of sources of radiation unless each such individual wears either a film badge or a thermoluminescent dosimeter (TLD). Each film badge or TLD shall be assigned to and worn by only one individual. Film badges must be replaced at least monthly and tlds replaced at least quarterly. After replacement, each film badge or TLD must be promptly processed.
15.17.b. Personnel monitoring records shall be maintained for inspection until the agency authorizes disposition.
15.18. Precautionary Procedures in Logging and Subsurface Tracer Studies
15.18.a. During each logging or tracer application, the logging supervisor or other designated employee shall maintain direct surveillance of the operation to protect against unauthorized or unnecessary entry into a restricted area, as defined in Section 1. of this rule.
15.18.b. The registrant shall provide and require the use of tools that will assure remote handling of sealed sources other than low-activity calibration sources.
15.18.c. Protective gloves and other appropriate protective clothing and equipment shall be used by all personnel handling radioactive tracer material. Precautions shall be taken to avoid ingestion or inhalation of radioactive material.
15.18.d. No registrant shall cause the injection of radioactive material into potable aquifers without prior written authorization from the agency.
15.19. Particle Accelerators. No registrant shall permit above-ground testing of particle accelerators, designed for use in well-logging, which results in the production of radiation, except in areas or facilities so controlled or shielded that the requirements of Subsections 6.4. and 6.5. of this rule, as applicable, are met.
15.20. Radiation Surveys
15.20.a. Radiation surveys or calculations shall be made and recorded for each area where radioactive materials are used and stored.
15.20.b. Radiation surveys shall be made and recorded for the radiation levels in occupied positions and on the exterior of each vehicle used to transport radioactive material. Such surveys shall include each source of radiation or combination of sources to be transported in the vehicle.
15.20.c. If the sealed source assembly is removed from the logging tool before departing the jobsite, the logging tool detector shall be energized, or a survey meter used, to assure that the logging tool is free of contamination.
15.20.d. Radiation surveys shall be made and recorded at the jobsite or well-head for each tracer operation, except those using Hydrogen-3, Carbon-14, and Sulfur-35. These surveys shall include measurements of radiation levels before and after the operation.
15.20.e. Records required pursuant to Subdivision 15.20.a. through d. shall include the dates, the identification of individuals making the survey, the identification of survey instruments used, and an exact description of the location of the survey. Records of these surveys shall be maintained for inspection by the agency for two years after completion of the survey.
15.21. Documents and Records Required at Field Stations. Each registrant shall maintain, for inspection by the agency, the following documents and records for the specific devices and sources used at the field station:
15.21.a. Appropriate registration, certificate of registration, or equivalent documents;
15.21.b. Operating and emergency procedures;
15.21.c. Applicable rules;
15.21.d. Records of the latest survey instrument calibrations pursuant to Subsection 15.8.;
15.21.e. Records of the latest leak test results pursuant to Subsection 15.9. ;
15.21.f. Records of quarterly inventories required pursuant to Subsection 15.10.;
15.21.g. Utilization records required pursuant to Subsection 15.11.;
15.21.h. Records of inspection and maintenance required pursuant to Subsection 15.14.;
15.21.i. Survey records required pursuant to Subsection 15.20.; and
15.21.j. Training records required pursuant to Subsection 15.15.
15.22. Documents and Records Required at Temporary Job sites. Each registrant conducting operations at a temporary jobsite shall have the following documents and records available at that site for inspection by the agency:
15.22.a. Operating and emergency procedures;
15.22.b. Survey records required pursuant to Subsection 15.20. for the period of operation at the site;
15.22.c. Evidence of current calibration for the radiation survey instruments in use at the site;
15.22.d. When operating in the state under reciprocity, a copy of the appropriate registration, certificate of registration, or equivalent document or documents; and
15.22.e. Shipping papers for the transportation of radioactive material.
15.23. Notification of Incidents, Abandonment, and Lost Sources
15.23.a. Notification of incidents and sources lost in other than downhole logging operations shall be made in accordance with appropriate provisions of Section 6. of this rule.
15.23.b. Whenever a sealed source or device containing radioactive material is lodged downhole, the registrant shall:
15.23.b.1. Monitor at the surface for the presence of radioactive contamination with a radiation survey instrument or logging tool during logging tool recovery operations; and
15.23.b.2. Notify the agency immediately by telephone and subsequently, within thirty (30) days, by confirmatory letter if the registrant knows or has reason to believe that a sealed source has been ruptured. This letter shall identify the well or other location, describe the magnitude and extent of the escape of radioactive material, assess the consequences of the rupture, and explain efforts planned or being taken to mitigate these consequences.
15.23.c. When it becomes apparent that efforts to recover the radioactive source will not be successful, the registrant shall:
15.23.c.1. Advise the well-operator of an appropriate method of abandonment, which shall include:
15.23.c.1.A. The immobilization and sealing in place of the radioactive source with a cement plug,
15.23.c.1.B. The setting of a whipstock or other deflection device, and
15.23.c.1.C. The mounting of a permanent identification plaque at the surface of the well, containing the appropriate information required by Subdivision 15.23.;
15.23.c.2. Notify the agency by telephone, giving the circumstances of the loss, and request approval of the proposed abandonment procedures; and
15.23.c.3. File a written report with the agency within thirty (30) days of the abandonment. The registrant shall send a copy of the report to the division of environmental protection that issued permits or otherwise approved of the drilling operation. The report shall contain the following information:
15.23.c.3.A. Date of occurrence;
15.23.c.3.B. A description of the well logging source involved, including the radionuclide and its quantity, chemical, and physical form;
15.23.c.3.C. Surface location and identification of the well;
15.23.c.3.D. Results of efforts to immobilize and seal the source in place;
15.23.c.3.E. A brief description of the attempted recovery effort;
15.23.c.3.F. Depth of the source;
15.23.c.3.G. Depth of the top of the cement plug;
15.23.c.3.H. Depth of the well;
15.23.c.3.I. Any other information, such as a warning statement, contained on the permanent identification plaque; and
15.23.c.3.J. The names of state agencies receiving a copy of this report.
15.23.d. Whenever a sealed source containing radioactive material is abandoned downhole, the registrant shall provide a permanent plaque18 for posting the well or well-bore. This plaque shall:
15.23.d.1. Be constructed of long-lasting material, such as stainless steel or monel; and
15.23.d.2. Contain the following information engraved on its face:
15.23.d.2.A. The word "CAUTION";
15.23.d.2.B. The radiation symbol without the conventional color requirement;
15.23.d.2.C. The date of abandonment;
15.23.d.2.D. The name of the well-operator or well-owner;
15.23.d.2.E. The well name and well identification number or numbers or other designation;
15.23.d.2.F. The sealed source or sources by radionuclide and activity;
15.23.d.2.G. The source depth and the depth to the top of the plug; and
15.23.d.2.H. An appropriate warning, depending on the specific circumstances of each abandonment.19
15.23.e. The registrant shall immediately notify the agency by telephone and subsequently by confirming letter if the registrant knows or has reason to believe that radioactive material has been lost in or to an underground potable aquifer. Such notice shall designate the well location and shall describe the magnitude and extent of loss of radioactive material, assess the consequences of such loss, and explain efforts planned or being taken to mitigate these consequences.
W. Va. Code R. § 64-23-16 Radiation Safety Requirements for Technologically Enhanced Radioactive Materials (TENORM)
16.1. Purpose. This Section establishes radiation protection standards for the possession, use, transfer, and disposal of technologically enhanced naturally occurring radioactive materials (TENORM).
16.2. Scope.
16.2.a. This rule apply to any person who receives, owns, possesses, uses, processes, transfers, distributes, or disposes of TENORM.
16.2.b. The rules in this Part address the introduction of TENORM into products in which neither the TENORM, nor the radiation emitted from the TENORM, is considered to be beneficial to the products.
16.2.c. The manufacture and distribution of products containing TENORM, in which the TENORM or its emitted radiation is considered to be a beneficial attribute, are registered under the provisions of Section 11. of this rule.
16.2.d. This Section does not apply to radionuclides for which NRC retains exclusive jurisdiction.
16.3. Definitions. As used in this Section, the following definitions apply:
16.3.a. Beneficial Attribute - the radioactivity of the product necessary to the use of the product.
16.3.b. Beneficial to the Product - the radioactivity of the product necessary to the use of the product.
16.3.c. General Environment - the total terrestrial, atmospheric, and aquatic environments outside the site boundary within which any activity, operation, or process authorized by a general or specific registration issued under this Section, is performed.
16.3.d. Institutional Controls: (1) Permanent markers placed at a disposal site, (2) public records and archives, (3) government ownership and rules regarding land or resource use, and (4) other methods of preserving knowledge about the location, design, and contents of a disposal system.
16.3.e. Product - something produced, made, manufactured, refined, or benefitted.
16.3.f. Reasonably Maximally Exposed Individual - a representative of a population who is exposed to TENORM at the maximum TENORM concentration measured in environmental media found at a site along with reasonable maximum case exposure assumptions. The exposure is determined by using maximum values for one or more of the most sensitive parameters affecting exposure, based on cautious but reasonable assumptions, while leaving the others at their mean value.
16.3.g. Technologically Enhanced Naturally Occurring Radioactive Material (TENORM) - naturally occurring radionuclides whose concentrations are increased by or as a result of past or present human practices. TENORM does not include background radiation or the natural radioactivity of rocks or soils. TENORM does not include uranium or thorium in "source material" as defined in the aea and US NRC regulations.
16.3.h. Transfer - the physical relocation of NORM containing materials not directly associated with commercial distribution within a business's operation or between general or specific registrants. This term does not include a change in legal title to NORM containing materials that does not involve physical movement of those materials.
16.3.i. Total Effective Dose Equivalent (TEDE) - the sum of the deep dose equivalent for external exposures and the committed effective dose equivalent for internal exposures.
16.4. Exemptions.
16.4.a. Persons who receive, own, possess, use, process, transfer, distribute, or dispose of TENORM are exempt from the requirements of this Section with respect to any combination of 226Ra and 228Ra if the materials contain, or are contaminated at, concentrations less than one hundred eighty five (185) bequerel per kilogram (five [5] pCi/gm) excluding natural background. This does not apply to consumer or retail products which are discussed in Subdivision 16.12.c. and Subsection 16.13. Using purposeful dilution to render TENORM waste exempt shall not be allowed without prior agency approval.
16.4.b. Persons who receive products or materials containing TENORM distributed in accordance with a specific registration issued by the agency pursuant to Subdivision 16.10.a., or to an equivalent registration issued by another licensing state, are exempt from this rule with regard to those products or materials.
16.4.c. The distribution, including custom blending, possession, and use of fertilizers containing TENORM, is exempt from the requirements of this Section.
16.4.d. TENORM waste regulated by CERCLA or RCRA (Resources Conservation and Recovery Act) are exempt from this Section.
16.4.e. The transportation and storage incident to transportation are governed by Sections 6. and 16. of this rule.
16.5. Standards for Radiation Protection for TENORM.
16.5.a. No person registered under Section 16.9. and 16.10. shall conduct operations, use, or transfer TENORM in a manner such that a member of the public will receive an annual total effective dose in excess of one (1) millisievert per year (one hundred [100] mRem/yr.) from all registered sources including TENORM.
16.5.b. Persons subject to a registration under this Section shall comply with radiation protection standards set out in Section 6. of this rule. . 16.5.c. Doses from indoor radon and its progeny shall not be included in total effective dose equivalent calculations.
16.5.d. No person shall release TENORM for unrestricted use in such a manner that the reasonably maximally exposed individual will receive an annual total effective dose equivalent from the released TENORM in excess of five-tenths (0.5) millisievert per year (fifty [50] mRem/yr.) excluding natural background.
16.6. Protection of Workers During Operations. Each person subject to a specific registration under this Section shall conduct operations in compliance with the standards for radiation protection set out in Sections 6. and 13. of this rule.
16.7. Release for Unrestricted Use. Each person subject to a registration under this Section shall:
16.7.a. Not transfer or release for unrestricted use facilities or equipment contaminated with TENORM in excess of levels in Table 64-23 Ii;
16.7.b. Not transfer or release for unrestricted use equipment contaminated with TENORM in excess of a surface gamma radiation level of < one hundred (100) microrems/hour including natural background; and
16.7.c. Not transfer land for unrestricted use where the concentration of 226Ra or 228Ra in soilaveraged over any one hundred (100) square meters exceeds the background level by more than one hundred eighty five (185) Bequerel per kilogram (five [5] pCi/gm), averaged over any fifteen (15) cm layer of soil below the surface, unless compliance with Subdivision 16.5.b. through d. can be demonstrated.
16.8. Disposal and Transfer of Waste for Disposal.
16.8.a. Each person subject to a registration under this rule shall manage and dispose of wastes containing TENORM:
16.8.a.1. By transfer of the wastes for disposal to a facility registration under requirements for uranium or thorium byproduct materials in either 40 CFR 192 or 10 CFR 40 Appendix A; or
16.8.a.2. By transfer of the wastes for disposal to a disposal facility licensed by the US Nuclear Regulatory Commission, an agreement state, or a licensing state; or
16.8.a.3. In accordance with alternate methods authorized by the agency upon application or upon the agency's initiative, consistent with Subsection 16.5. and where applicable the clean water act, safe drinking water act and other requirements of the US Environmental Protection Agency for disposal of such wastes.
16.8.b. Equipment contaminated with TENORM in excess of levels specified in Table Oo, which is to be disposed of as waste, shall be disposed of:
16.18.b.1. So as to prevent any reintroduction into commerce or unrestricted use; and
16.18.b.2. Within disposal areas specifically designed to meet the criteria of Subdivision 16.8.a.
16.8.c. Transfers of waste containing TENORM for disposal shall be made only to a person specifically authorized by the Nuclear Regulatory Commission, an agreement state or a licensing state, to receive such waste.
16.8.d. Records of disposal, including manifests, shall be maintained pursuant to the provisions of Section 6. of this rule.
16.9. General Registration
16.9.a. Subject to the requirements of Subsections 16.5. through 16.8. and Subdivision 16.10., a general registration is hereby issued to possess, own, use, transfer, distribute or dispose of TENORM without regard to quantity.
16.9.b. This general registration does not authorize the manufacturing of products containing TENORM in concentrations greater than those specified in Subsection 16.4. nor the receipt and disposal of wastes from other persons.
16.9.c. The decontamination of equipment, facilities, and land shall be preformed only by persons specifically registered by the agency or another licensing state to conduct such work. However, employees or contractors under control and supervision of a general registration can perform routine maintenance on equipment, facilities, and land owned or controlled by the general registration. Maintenance that provides a different pathway for exposure than is found in daily operations and that increases the potential for additional exposure is not considered routine.
16.9.d. Transfer of material or real property.
16.9.d.1. The transfer of TENORM not exempt from this rule from one general registrant to another general registrant is authorized if:
16.9.d.1.A. The equipment and facilities contaminated with TENORM are to be used by the recipient for the same purpose; or
16.9.d.1.B. The transfer of control or ownership of land contaminated with TENORM includes notice to owners of surface and mineral rights to indicate the presence of TENORM.
16.9.d.2. Transfers not made in accordance with Paragraph 16.9.d.1. require prior approval by the agency.
16.9.d.3. Transfers made under Paragraph 16.9.d.1. do not relieve the general registrant who makes the transfer from the responsibilities of assessing the extent of TENORM contamination or material present, informing the general registrant receiving the TENORM of these assessments, and maintaining records required by this rule.
16.9.d.4. A general registrant intending to transfer material or real property for unrestricted use shall document compliance with the requirements of Subsection 16.7. of this regulation. Records of such compliance shall be kept .
16.9.e. Distribution of TENORM products between general registrants. The distribution of TENORM products not exempt from this rule from one general registration to another general registrant is authorized provided the product is accompanied by labels or manifests which identify the type and amount of TENORM.
16.9.f. The Division of Health may, by written notice, require any person authorized by a general registration to apply for and obtain a specific registration. The notice shall state the reason or reasons for requiring a specific registration.
16.10. Specific Registration. Unless otherwise exempt, a specific registration is required to:
16.10.a. Manufacture and distribute any material or product containing TENORM unless authorized by Subdivision 16.9.e., exempted under the provisions of Subsection 16.4., or registered under the provisions of Section 6. of this rule;
16.10.b. Except as provided in Subdivision 16.9.c., decontaminate equipment or land not otherwise exempted under the provisions of Subsection 16.4. or facilities contaminated with TENORM in excess of the levels set forth in Subsection 16.7., as applicable; for purposes of this Subsection, the term "decontaminate" shall not include maintenance which incidentally results in removal of contamination;
16.10.d. Receive TENORM from other persons for disposal.
16.11. Filing Application for Specific Registration.
16.11.a. Applications for specific registration shall be filed in a manner and on a form prescribed by the agency.
16.11.b. The agency may at any time after the filing of the original application, and before the expiration of the registration, require further statements in order to enable the agency to determine whether the application should be granted or denied or whether a registration should be modified or revoked.
16.11.c. Each application shall be signed by the applicant or registrant or a person duly authorized to act for and on the registrant’s behalf.
16.11.d. An application for a registration may include a request for a registration authorizing one or more activities.
16.11.e. In an application, the applicant may incorporate by reference information contained in previous applications, statements, or reports filed with the agency provided such references are clear and specific.
16.11.f. Applications and documents submitted to the agency may be made available for public inspection.
16.12. Requirements for the Issuance of Specific Registrations.
16.12.a. A registration application will be approved if the agency determines that:
16.12.a.1. The applicant is qualified by reason of training and experience to use the TENORM in question for the purpose requested in accordance with this rule in such a manner as to protect the public health and safety or property;
16.12.a.2. The applicant's proposed equipment, facilities, and procedures are adequate to protect the public health and safety or property;
16.12.a.3. The issuance of the registrant will not be inimical to the health and safety of the public;
16.12.a.4. The applicant satisfied all applicable special requirements in this Section; and
16.12.a.5. The applicant has met the financial surety requirements of Subsection 16.23.
16.12.a.6. The applicant has adequately addressed the following items in the application:
16.12.a.6.A. Procedures and equipment for monitoring and protecting workers;
16.12.a.6.B. An evaluation of the radiation levels and concentrations of contamination expected during normal operations;
16.12.a.6.C. Operating and emergency procedures, including procedures for waste reduction and quality assurance of items released for unrestricted use; and
16.12.a.6.D. A method for managing the radioactive material removed from contaminated equipment and facilities.
16.12.b. An application for a specific registration to decontaminate equipment, land, or facilities contaminated with TENORM in excess of the levels set forth in Subdivisions 16.4.a., 16.7.b., or Table Oo, as applicable, and to dispose of the resulting waste will be approved if:
16.12.b.1. The applicant satisfies the general requirements specified in Subdivision 16.12.a.; and
16.12.b.2. The applicant has adequately addressed the following items in the application:
16.12.b.2.A. Procedures and equipment for monitoring and protection of workers;
16.12.b.2.B. An evaluation of the radiation levels and concentrations of contamination expected during normal operations;
16.12.b.2.C. Operating and emergency procedures, including procedures for waste reduction and quality assurance of items released for unrestricted use; and
16.12.b.2.D. Method of disposing of the TENORM removed from contaminated equipment, facilities, and land.
16.12.c. An application for a specific license to transfer materials or manufacture or distribute products containing TENORM to persons exempted from this rule pursuant to Subdivision 16.4.b. will be approved if:
16.12.c.1. The applicant satisfies the general requirements specified in Subdivision 16.22.a.;
16.12.c.2. The TENORM is not contained in any food, beverage, cosmetic, drug, or other commodity designed for ingestion or inhalation by, or application to, a human being; and
16.12.c.3. The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control procedures, labeling or marking, and conditions of handling, storage, use, and disposal of the TENORM material or product to demonstrate that the material or product will meet the safety criteria set forth in Subsection 16.13. The information shall include:
16.12.c.3.A. A description of the material or product and its intended use or uses;
16.12.c.3.B. The type, quantity, and concentration of TENORM in each material or product;
16.12.c.3.C. The chemical and physical form of the TENORM in the material or product, and changes in chemical and physical form that may occur during the useful life of the material or product;
16.12.c.3.D. An analysis of the solubility in water and body fluids of the TENORM in the material or product;
16.12.c.3.E. The details of manufacture and design of the material or product relating to containment and shielding of the TENORM and other safety features under normal and severe conditions of handling, storage, use, reuse, and disposal of the material or product;
16.12.c.3.F. The degree of access of human beings to the material or product during normal handling, use, and disposal;
16.12.c.3.G. The total quantity of TENORM expected to be distributed annually in the material or product;
16.12.c.3.H. The expected useful life of the material or product;
16.12.c.3.I. The proposed method of labeling or marking each unit of the material or product with identification of the manufacturer or initial transferor of the product and the radionuclides and quantity of TENORM in the material or product;
16.12.c.3.J. The procedures for prototype testing of the material or product to demonstrate the effectiveness of the containment, shielding, and other safety features under both normal and severe conditions of handling, storage, use, reuse, and disposal;
16.12.c.3.K. The results of the prototype testing of the material or product, including any change in the form of the TENORM contained in it, the extent to which the TENORM may be released to the environment, any change in radiation levels, and any other changes in safety features;
16.12.c.3.L. The estimated external radiation doses and dose commitments relevant to the safety criteria in Subsection 16.13. and the basis for such estimates;
16.12.c.3.M. A determination that the probabilities with respect to doses referred to in Subsection 16.13. meet the safety criteria;
16.12.c.3.N. The quality control procedures to be followed in the production of production lots of the material or product, and the quality control standards the material or product will be required to meet; and
16.12.c.3.O. Any additional information, including experimental studies and tests, required by the agency to facilitate a determination of the radiation safety of the material or product.
16.12.d. Notwithstanding the provisions of Subdivision 16.13.b., the agency may deny an application for a specific registration if the end uses of the product are frivolous or cannot be reasonably foreseen.
16.13. Safety Criteria for Products. An applicant for a registration under Subdivision 16.12.c. shall demonstrate that the product is designed and will be manufactured so that:
16.13.a. In normal use and disposal of a single exempt item, and in normal handling and storage of the quantities of exempt items likely to accumulate in one location during marketing, distribution, installation, and servicing of the product, it is unlikely that the TEDE in any one year, to a suitable sample of the group of individuals expected to be most highly exposed to radiation or radioactive material from the product will exceed the doses in Column I of 16.14.
16.13.b. In use and disposal of a single exempt item and in handling and storage of the quantities of exempt items likely to accumulate in one location during marketing, distribution, installation, and servicing of the product, the probability is low that the containment, shielding, or other safety features of the product would fail under such circumstances that a person would receive an external radiation dose or dose commitment in excess of the dose to the appropriate organ as specified in Column II of the Table in Subsection 16.14. and the probability is negligible that a person would receive an external radiation dose or dose commitment in excess of the dose to the appropriate organ as specified in Column III of the Table in Subsection 16.14.
16.13.c. It is unlikely that there will be a significant reduction in the effectiveness of the containment, shielding, or other safety features of the product from wear and abuse likely to occur in normal handling and use of the product during its useful life.
16.14. Table of Organ Doses.
16.15. Issuance of Specific Registrations.
16.15.a. Upon a determination that an application meets the requirements of this rule, the agency will issue a specific registration authorizing the proposed activity in such form and containing such conditions and limitations as it deems appropriate or necessary.
16.15.b. The agency may incorporate in any license at the time of issuance, or thereafter by amendment, such additional requirements and conditions with respect to the registrant’s receipt, possession, use, and transfer of TENORM subject to this Section as it deems appropriate or necessary in order to:
16.15.b.1. Protect public health and safety or property;
16.15.b.2. Require such reports and the keeping of such records, and to provide for such inspections of activities under the license as may be appropriate or necessary; and
16.15.b.3. Prevent loss, theft, or loss of control of TENORM subject to this Section.
16.16. Conditions of Specific Registration Issued Under Section 16.12.
16.16.a. General Terms and Conditions
16.16.a.1. Each registration issued pursuant to this Section shall be subject to all the provisions of this rule, now or hereafter in effect, and to all rules, and orders of the agency.
16.16.a.2. No registration issued or granted under this Section and no right to possess or utilize TENORM granted by any registration issued pursuant to this Section shall be transferred, assigned, or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of any registration to any person unless the agency shall, after securing full information, find that the transfer is in accordance with the provisions of this rule, and shall give its consent in writing.
16.16.a.3. Each person registered by the agency pursuant to this Section shall confine use and possession of the TENORM registered to the locations and purposes authorized in the registration.
16.16.a.4. Each person registered by the agency pursuant to this Section is subject to the general license provisions of Subsections 16.6, 16.7. and 16.8.
16.16.a.5. Each registrant shall:
16.16.a.5.A. Notify the agency, in writing, immediately following the filing of a voluntary or involuntary petition for bankruptcy under any Chapters of Title II (bankruptcy) of the United States Code (11 U.S.C.) by or against:
16.16.a.5.A.1. A registrant;
16.16.a.5.A.2. An entity controlling a registrant or listing the registration or registrant as property of the estate; or
16.16.a.5.A.3. An affiliate of the registrant.
16.16.a.5.B. Indicate in their Bankruptcy notification:
16.16.a.5.B.1. The bankruptcy court in which the petition for bankruptcy was filed; and
16.16.a.5.B.2. The date of the filing of the petition.
16.16.b. Quality Control, Labeling, and Reports of Transfer. Each person registered under Subdivision 16.12.c. shall:
16.16.b.1. Carry out adequate control procedures in the manufacture of the product to assure that each production lot meets the quality control standards approved by the agency;
16.16.b.2. Label or mark each unit so that the manufacturer, processor, producer, or initial transferor of the material or product and the TENORM in the product can be identified; and
16.16.b.3. Maintain records identifying, by name and address, each person to whom TENORM is transferred for use under Subdivision 16.4.b. or the equivalent regulations of a licensing state, and stating the kinds, quantities, and uses of TENORM transferred. An annual summary report stating the total quantity of each radionuclide transferred under the specific registration shall be filed with the agency. Each report shall cover the year ending December 31, and shall be filed within ninety (90) days thereafter. If no transfers of TENORM have been made pursuant to Subdivision 16.12.c. during the reporting period, the report shall so indicate.
16.17. Expiration and Termination of Specific Registrations.
16.17.a. Except as provided in Paragraph 16.17.d.6. and Subdivision 16.18.b., each specific registration shall expire at the end of the specified day in the month and year stated therein.
16.17.b. Each registrant shall notify the agency in writing and request termination of the registration when the registrant decides to terminate all activities involving TENORM authorized under the registration. This notification and request for termination of the registration must include the reports and information specified in Paragraph 16.17.d.6. The registrant is subject to the provisions of Subdivisions 16.17.d. and 16.17.e., as applicable.
16.17.c. No less than thirty (30) days before the expiration date specified in a specific registration, the registrant shall either:
16.17.c.1. Submit an application for registration renewal under Subsection 16.18.; or
16.17.c.2. Notify the agency in writing, under Subdivision 16.17.b., if the registrant decides to discontinue all activities involving TENORM.
16.17.d. If a registrant does not submit an application for registration renewal under Subsection 16.18., the registrant shall, on or before the expiration date specified in the registration:
16.17.d.1. Terminate use of TENORM;
16.17.d.2. Remove TENORM contamination consistent with the requirements of Subsection 16.7.;
16.17.d.3. Properly dispose of TENORM; and
16.17.d.4. Submit a report of disposal of TENORM and radiation surveys to confirm the absence of TENORM or to establish the levels of residual TENORM contamination. The registrant shall, as appropriate:
16.17.d.4.A. Report levels of radiation in units of microroentgens per hour of beta and gamma radiation at one (1) centimeter and gamma radiation at one meter from surfaces and report levels of radioactivity in units of disintegrations per minute (or microcuries) per one hundred (100) square centimeters removable and fixed on surfaces, microcuries or Becquerel per milliliter in water, and picocuries or Becquerels per gram in contaminated solids such as soils or concrete; and
16.17.d.4.B. Specify the instruments used and certify that each instrument is properly calibrated and tested.
16.17.d.5. If levels of residual activity are less than those established in Subsection 16.7., the registrant shall so certify. If the agency determines that this certification and the information submitted under Paragraph 16.17.d.4. is adequate and surveys confirm the findings, the agency will notify the registrant in writing that the registration is terminated.
16.17.d.6. If levels of residual TENORM are not in conformance with criteria established in Subsection 16.17., the registration continues in effect beyond the expiration date, if necessary, with respect to possession of residual TENORM until the agency notifies the registrant in writing that the registration is terminated. During this time, the registrant is subject to the provisions of Subdivision 16.17.e. In addition to the information submitted under Paragraph 17.17.d.4., the registrant shall submit a plan, if appropriate, for decontaminating the location or locations and disposing of the residual TENORM.
16.17.e. Each registrant who possesses residual TENORM under Paragraph 16.17.d.6., following the expiration date specified in the registration, shall:
16.17.e.1. Be limited to actions involving TENORM related to preparing the locations for release for unrestricted use; and
16.17.e.2. Continue to control entry to restricted areas until the locations are suitable for release for unrestricted use and the agency notifies the registrant in writing that the registration is terminated.
16.18. Renewal of Specific Registrations.
16.18.a. Applications for renewal of specific registrations shall be filed in accordance with Subsection 16.11.
16.18.b. In any case in which a registration, not less than thirty (30) days prior to expiration of an existing registration, has filed an application in proper form for renewal or for a new registration authorizing the same activities, such existing registration shall not expire until final action by the agency.
16.19. Amendment of Specific Registrations at Request of Registrant. Applications for amendment of a registration shall be filed in accordance with Subsection 16.11. and shall specify the respects in which the registrant desires the registration to be amended and the grounds for such amendment.
16.20. Agency Action on Applications to Renew and Amend Specific Registrations. In considering an application by a registrant to renew or amend the registration, the agency will apply the criteria set forth in Subsection 16.12.
16.21. Modification and Revocation of Specific Registrations.
16.21.a. The terms and conditions of all registrations shall be subject to amendment, revision, or modification or the registration may be suspended or revoked by reason of amendments to this rule, or by reason of rules, regulations, and orders issued by the agency.
16.21.b. Any registration may be revoked, suspended, or modified, in whole or in part, for any material false statement in the application or any statement of fact required under provisions of this rule, or because of conditions revealed by such application or statement of fact or any report, record, or inspection or other means which would warrant the agency to refuse to grant a registration on an original application, or for violation of, or failure to observe any of the terms and conditions of this rule, or of the registration, or of any rule, regulation, or order of the agency.
16.21.c. Except in cases of willfulness or those in which the public health, interest or safety requires otherwise, the agency shall not modify, suspend or revoke a registration prior to the institution of proceedings unless facts or conduct which may warrant such action shall have been called to the attention of the registrant in writing and the registrant shall have been accorded an opportunity to demonstrate or achieve compliance with all lawful requirements.
16.22. Reciprocal Recognition of Specific Registrations. Subject to this rule, any person who holds a specific registration from an agreement state or a licensing state, and issued by the agency having jurisdiction where the registrant maintains an office for directing the registered activity and at which radiation safety records are normally maintained, is hereby granted a general registration to conduct the activities authorized in such registering document within this state for a period not in excess of 180 days in any calendar year provided that:
16.22.a. The registering document does not limit the activity authorized by such document to specified installations or locations;
16.22.b. The out-of-state registrant notifies the agency in writing at least three (3) days prior to engaging in such activity. Such notification shall indicate the location, period, and type of proposed possession and use within the State, and shall be accompanied by a copy of the pertinent registering document. If, for a specific case, the three (3) day period would impose an undue hardship on the out-of-state registrant , the registrant may, upon application to the agency, obtain permission to proceed sooner. The agency may waive the requirement for filing additional written notifications during the remainder of the calendar year following the receipt of the initial notification from a person engaging in activities under the general registration provided in Subdivision 16.22.a.;
16.22.c. The out-of-state registrant complies with all applicable rules of the agency and with all the terms and conditions of the registering document, except any such terms and conditions which may be inconsistent with applicable rules of the agency;
16.22.d. The out-of-state registrant supplies such other information as the agency may request; and
16.22.e. The out-of-state registrant shall not transfer or dispose of TENORM possessed or used under the general registration provided in Subdivision 16.22.a. except by transfer to a person:
16.22.e.1. Specifically registered by the agency or by another licensing state to receive such TENORM; or
16.22.e.2. Exempt from the requirements for a registration for such TENORM under Section 16.4.
16.23. Financial Surety Arrangements. Pursuant to §64 CSR 23, each registrant or applicant for a registration under Subsection 16.12. shall post with the agency financial surety, or security, to ensure the protection of the public health and safety and the environment in the event of abandonment, default, or other inability or unwillingness of the registrant to meet the requirements of this rule. Financial surety arrangements shall:
16.23.a. Consist of cash deposits, certificates of deposit, government securities, irrevocable letters or lines of credit, or any combination of these;
16.23.b. Be in an amount sufficient to meet the applicant's or registrant’s obligations under the act and this rule and shall be based upon agency approved cost estimates;
16.23.c. Be established prior to issuance of the registration or the commencement of operations to assure that sufficient funds will be available to carry out the decontamination and decommissioning of the facility;
16.23.d. Be continuous for the duration of the registration and for a period coincident with the applicant or registrant responsibility under this rule;
16.23.e. Be available in West Virginia subject to judicial process and execution in the event required for the purposes set forth; and
16.23.f. Be established within ninety (90) days of July 1, 2001 for registrations in effect on that date.
TABLE 64-23 A
QUALITY FACTORS AND ABSORBED DOSE EQUIVALENCIES
Type of Radiation Quality Factor (Q)
Absorbed Dose Equal to a Unit Dose Equivalenta X, gamma, or beta radiation and high-speed electrons Alpha particles, multiple-charged particles, fission fragments and heavy particles of unknown charge
0.05 Neutrons of unknown energy
0.1 High-energy protons
0.1 a Absorbed Dose in Gray Equal to one (1) Sv or the Absorbed Dose in Rad Equal to one (1) Rem.
TABLE 64-23 B
MEAN QUALITY FACTORS, Q, AND FLUENCE PER UNIT DOSE
EQUIVALENT FOR MONOENERGETIC NEUTRONS
Neutron Energy (MeV)
Quality Factora (Q)
Fluence per Unit Dose Equivalentb (Neutrons cm-2 Rem -1)
Fluence per Unit Dose Equivalentb (Neutrons cm-2 Sv-1) thermal 2.5E-8 980E+6 980E+8 1E-7 980E+6 980E+8 1E-6 810E+6 810E+8 1E-5 810E+6 810E+8 1E-4 840E+6 840E+8 1E-3 980E+6 980E+8 1E-2
2.5 1010E+6
1010E+8
1E-1
7.5 170E+6
170E+8
5E-1
39E+6
39E+8
27E+6
27E+8
2.5 29E+6
29E+8
23E+6
23E+8
24E+6
24E+8
6.5 24E+6
24E+8
7.5 17E+6
17E+8
16E+6
16E+8
14E+6
14E+8
5.5 16E+6
16E+8
1E+2
20E+6
20E+8
2E+2
19E+6
19E+8
3E+2
16E+6
16E+8
4E+2
14E+6
14E+8 a Value of quality factor (Q) at the point where the dose equivalent is maximum in a thirty (30) centimeter diameter cylinder tissue-equivalent phantom. b Monoenergetic neutrons incident normally on a thirty (30) centimeter diameter cylinder tissue-equivalent phantom.
TABLE 64-23 C
Organ Dose Weighting Factors Organ or Tissue wT Gonads
0.25 Breast
0.15 Red bone marrow
0.12 Lung
0.12
0.03 Bone surfaces
0.03 Remainder 0.30a Whole Body 1.00b a Three one-hundredths (0.30) results from six one-hundredths (0.06) for each of five (5) "remainder" organs, excluding the skin and the lens of the eye, that receive the highest doses. b For the purpose of weighting the external whole body dose, for adding it to the internal dose, a single weighting factor, wT = one (1.0), has been specified. The use of other weighting factors for external exposure will be approved on a case-by-case basis until such time as specific guidance is issued.
TABLE 64-23 D
Radionuclide Activity Ci GBq Cesium-137 Cobalt-60 Gold-198 3,700 Iodine-131 Iridium-192 Krypton-85 1,000 37,000 Promethium-147 Technetium-99m 1,000 37,000 TABLE 64-23 E PROTECTION FACTORS FOR RESPIRATORS a Protection Factorsd Tested & Certified Equipment Descriptionb Modesc Particulates Particulates National Institute for only gases, Occupational Safety & vaporse Health & Mine Safety & Health Administration tests for permissibility I. AIR-PURIFYING RESPIRATORSf/ Facepiece, half-maskg NP 10 CFR 11, Facepiece, full NP 50 Subpart K.
Facepiece, half-mask PP 1000 full, or hood II. ATMOSPHERE-SUPPLYING RESPIRATORS 1. Air-line respirator Facepiece, half-mask CF 1000 Facepiece, half-mask D 5 Facepiece, full CF 2000 Facepiece, full D 5 30 CFR 11, Facepiece, full PD 2000 Subpart J.
Hood CF h/ Suit CF I j 2. Self-contained breathing apparatus (SCBA)
Facepiece, full D 50 Facepiece, full PD 10,000k 30 CFR 11, Facepiece, full 50 Subpart H.
Facepiece, full RP 5,000l III. COMBINATION RESPIRATORS Any combination of Protection factor air-purifying and For type and mode 30 CFR 11, atmosphere-supplying of operation as Sec. 11.63(b). respirators listed above Footnotes: a For use in the selection of respiratory protective equipment to be used only where the contaminants have been identified and the concentrations, or possible concentrations, are known. b Only for shaven faces and where nothing interferes with the seal of tight-fitting facepieces against the skin. Hoods and suits are excepted. c The mode symbols are defined as follows:
CF = continuous flow D = demand NP = negative pressure, that is, negative phase during inhalation PD = pressure demand, that is, always positive pressure PP = positive pressure RD = demand, recirculating or closed circuit RP = pressure demand, recirculating or closed circuit di. The protection factor is a measure of the degree of protection afforded by a respirator, defined as the ratio of the concentration of airborne radioactive material outside the respiratory protective equipment to that inside the equipment, usually inside the facepiece, under conditions of use. It is applied to the ambient airborne concentration to estimate the concentrations inhaled by the wearer according to the following formula:
Concentration inhaled = Ambient airborne concentration Protection factor ii. The protection factors apply:
(1) Only for individuals trained in using respirators and wearing properly fitted respirators that are used and maintained under supervision in a well-planned respiratory protective program.
(2) For air-purifying respirators only when high efficiency particulate filters, above ninety nine and ninety seven one-hundredths (99.97) percent removal efficiency by thermally generated three tenths (0.3) m dioctyl phthalate (DOP) test or equivalent, are used in atmospheres not deficient in oxygen and not containing radioactive gas or vapor respiratory hazards.
(3) No adjustment is to be made for the use of sorbents against radioactive material in the form of gases or vapors.
(4) For atmosphere-supplying respirators only when supplied with adequate respirable air. Respirable air shall be provided of the quality and quantity required in accordance with the National Institute for Occupational Safety and Health and the Mine Safety and Health Administration certification described in 30 CFR 11. Oxygen and air shall not be used in the same apparatus. e Excluding radioactive contaminants that present an absorption or submersion hazard. For tritium oxide, approximately one-third of the intake occurs by absorption through the skin so that an overall protection factor of less than two (2) is appropriate when atmosphere-supplying respirators are used to protect against tritium oxide. If the protection factor for respiratory protective equipment is five (5), the effective protection factor for tritium is about one and four tenths (1.4); with protection factors of ten (10), the effective factor for tritium oxide is about one and seven tenths (1.7); and with protection factors of one hundred (100) or more, the effective factor for tritium oxide is about one and nine tenths (1.9). Air-purifying respirators are not suitable for protection against tritium oxide. See also footnote I/ concerning supplied-air suits. f Canisters and cartridges shall not be used beyond service-life limitations. g Under-chin type only. This type of respirator is not satisfactory for use where it might be possible, such as, if an accident or emergency were to occur, for the ambient airborne concentrations to reach instantaneous values greater than ten (10) times the pertinent values in Table I, Column three (3) of Table 64-23 F. This type of respirator is not suitable for protection against plutonium or other high-toxicity materials. The mask is to be tested for fit prior to use, each time it is donned. h i. Equipment shall be operated in a manner that ensures that proper air flow-rates are maintained. A protection factor of no more than one thousand (1000) may be utilized for tested-and-certified supplied-air hoods when a minimum air flow of six (6) cubic feet per minute seventeen one-hundredths ([0.17] m3/min) is maintained and calibrated air line pressure gauges or flow measuring devices are used. A protection factor of up to tho thousand (2000) may be used for tested and certified hoods only when the air flow is maintained at the manufacturer's recommended maximum rate for the equipment, this rate is greater than six (6) cubic feet per minute seventeen one-hundredths ([0.17] m3/min) and calibrated air line pressure gauges or flow measuring devices are used.
ii. The design of the supplied-air hood or helmet, with a minimum flow of six (6) cubic feet per minute seventeen one-hundredths ([0.17] m3/min) of air, may determine its overall efficiency and the protection it provides. For example, some hoods aspirate contaminated air into the breathing zone when the wearer works with hands-over-head. This aspiration may be overcome if a short cape-like extension to the hood is worn under a coat or overalls. Other limitations specified by the approval agency shall be considered before using a hood in certain types of atmospheres. See footnote 1. i Appropriate protection factors shall be determined, taking into account the design of the suit and its permeability to the contaminant under conditions of use. There shall be a standby rescue person equipped with a respirator or other apparatus appropriate for the potential hazards and communications equipment whenever supplied-air suits are used. j No approval schedules are currently available for this equipment. Equipment is to be evaluated by testing or on the basis of reliable test information. k This type of respirator may provide greater protection and be used as an emergency device in unknown concentrations for protection against inhalation hazards. External radiation hazards and other limitations to permitted exposure, such as skin absorption, must be taken into account in such circumstances. l Quantitative fit testing shall be performed on each individual, and no more than two one-hundredths (0.02) percent leakage is allowed with this type of apparatus. Perceptible outward leakage of gas from this or any positive pressure self-contained breathing apparatus is unacceptable because service life will be reduced substantially. Special training in the use of this type of apparatus shall be provided to the wearer.
Note 1: Protection factors for respirators approved by the Bureau of Mines and the National Institute for Occupational Safety and Health, according to applicable approvals for respirators for type and mode of use to protect against airborne radionuclides, may be used to the extent that they do not exceed the protection factors listed in this table. The protection factors listed in this table may not be appropriate to circumstances where chemical or other respiratory hazards exist in addition to radioactive hazards. The selection and use of respirators for such circumstances should take into account applicable approvals of the Bureau of Mines and the National Institute for Occupational Safety and Health.
Note 2: Radioactive contaminants, for which the concentration values in Table I, Column three (3) of Table 64-23 F are based on internal dose due to inhalation, may present external exposure hazards at higher concentrations. Under these circumstances, limitations on occupancy may have to be governed by external dose limits.
TABLE 64-23 F
Annual Limits on Intake (Ali) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure; Effluent Concentrations; Concentrations for Release to Sanitary Sewerage Introduction For each radionuclide, table i indicates the chemical form which is to be used for selecting the appropriate ALI or DAC value. The ALIs and DACs for inhalation are given for an aerosol with an activity median aerodynamic diameter (AMAD) of one (1) μm, micron, and for three classes (D,W,U) of radioactive material, which refer to their retention (approximately days, weeks or years) in the pulmonary region of the lung. This classification applies to a range of clearance half-times for D if less than ten (10) days, for W from ten (10) to one hundred (100) days, and for Y greater than one hundred (100) days. The class (d, w, or y) given in the column headed "class" applies only to the inhalation ALIs and DACs given in Table I, Column 2 and 3. Table II provides concentration limits for airborne and liquid effluents released to the general environment. Table III provides concentration limits for discharges to sanitary sewerage.
Note: The values in Tables I, II, and III are presented in the computer "e" notation. In this notation a value of 6E-02 represents a value of 6 x 10-2 or 0.06, 6E+2 represents 6 x 1O2 or 600, and 6E+0 represents 6 x 100 or 6.
Table I "Occupational Values"
Note that the columns in Table I of this appendix captioned "oral ingestion ALI," "inhalation ALI," and "DAC," are applicable to occupational exposure to radioactive material.
The ALIs in this appendix are the annual intakes of given radionuclide by "reference man" which would result in either (1) a committed effective dose equivalent of five one-hundredths (0.05) Sv (five [5] Rem), stochastic ALI, or (2) a committed dose equivalent of five one-hundredths (0.5) Sv (fifty [50] Rem) to an organ or tissue, non-stochastic ALI. The stochastic ALIs were derived to result in a risk, due to irradiation of organs and tissues, comparable to the risk associated with deep dose equivalent to the whole body of five one-hundredths (0.05) Sv (five [5] Rem). The derivation includes multiplying the committed dose equivalent to an organ or tissue by a weighting factor, wT. This weighting factor is the proportion of the risk of stochastic effects resulting from irradiation of the organ or tissue, t, to the total risk of stochastic effects when the whole body is irradiated uniformly. The values of wT are listed under the definition of weighting factor in Subsection 2.0. The non-stochastic ALIs were derived to avoid non-stochastic effects, such as prompt damage to tissue or reduction in organ function.
A value of wT = is one-hundredths (0.06) is applicable to each of the five (5) organs or tissues in the "remainder" category receiving the highest dose equivalents, and the dose equivalents of all other remaining tissues may be disregarded. The following portions of the GI tract -- stomach, small intestine, upper large intestine, and lower large intestine -- are to be treated as four (4) separate organs.
Note that the dose equivalents for an extremity, skin and lens of the eye are not considered in computing the committed effective dose equivalent, but are subject to limits that must be met separately.
When an ALI is defined by the stochastic dose limit, this value alone is given. When an ALI is determined by the non-stochastic dose limit to an organ, the organ or tissue to which the limit applies is shown, and the ALI for the stochastic limit is shown in parentheses. Abbreviated organ or tissue designations are used:
LLI wall = lower large intestine wall;
St wall = stomach wall;
Blad wall = bladder wall; and Bone surf = bone surface.
The use of the ALIs listed first, the more limiting of the stochastic and non-stochastic ALIs, will ensure that non-stochastic effects are avoided and that the risk of stochastic effects is limited to an acceptably low value. If, in a particular situation involving a radionuclide for which the non-stochastic ALI is limiting, use of that non-stochastic ALI is considered unduly conservative, the registrant may use the stochastic ALI to determine the committed effective dose equivalent. However, the registrant shall also ensure that the five tenths (0.5) Sv (fifty [50] Rem) dose equivalent limit for any organ or tissue is not exceeded by the sum of the external deep dose equivalent plus the internal committed dose equivalent to that organ, not the effective dose. For the case where there is no external dose contribution, this would be demonstrated if the sum of the fractions of the nonstochastic ALIs (ALIns) that contribute to the committed dose equivalent to the organ receiving the highest dose does not exceed unity, that is, (intake (in Ci) of each radionuclide/ALIns) one (1.0). If there is an external deep dose equivalent contribution of Hd, then this sum must be less than one (1) - (Hd/50), instead of one (1.0).
Note that the dose equivalents for an extremity, skin, and lens of the eye are not considered in computing the committed effective dose equivalent, but are subject to limits that must be met separately.
The derived air concentration (DAC) values are derived limits intended to control chronic occupational exposures. The relationship between the DAC and the ALI is given by:
DAC = ALI(in μCi)/(two thousand [2000] hours per working year x sixty [60] minutes/hour x twenty thousand (2 x 104 ) ml per minute) =(ALI/two billion four hundred million [2.4 x 109])μCi/ml, where twenty thousand (2 x 104 ) ml is the volume of air breathed per minute at work by reference man under working conditions of light work.
The DAC values relate to one (1) of two (2) modes of exposure: either external submersion or the internal committed dose equivalents resulting from inhalation of radioactive materials. DACs based upon submersion are for immersion in a semi-infinite cloud of uniform concentration and apply to each radionuclide separately.
The ALI and DAC values include contributions to exposure by the single radionuclide named and any in-growth of daughter radionuclides produced in the body by decay of the parent. However, intakes that include both the parent and daughter radionuclides should be treated by the general method appropriate for mixtures.
The values of ALI and DAC do not apply directly when the individual both ingests and inhales a radionuclide, when the individual is exposed to a mixture of radionuclides by either inhalation or ingestion or both, or when the individual is exposed to both internal and external irradiation. See Subsection 6.6. When an individual is exposed to radioactive materials which fall under several of the translocation classifications of the same radionuclide, such as, class D, class W, or class Y, the exposure may be evaluated as if it were a mixture of different radionuclides.
It should be noted that the classification of a compound as class d, w or y is based on the chemical form of the compound and does not take into account the radiological half-life of different radionuclides. For this reason, values are given for class D, W and Y compounds, even for very short-lived radionuclides.
Table II "Effluent Concentrations"
The columns in Table II of this table captioned "effluents," "air" and "water" are applicable to the assessment and control of dose to the public, particularly in the implementation of the provisions of Subsection 6.14. The concentration values given in columns one (1) and two (2) of Table II are equivalent to the radionuclide concentrations which, if inhaled or ingested continuously over the course of a year, would produce a total effective dose equivalent of five tenths (0.5) mSv (five one-hundredths [0.05] Rem).
Consideration of non-stochastic limits has not been included in deriving the air and water effluent concentration limits because non-stochastic effects are presumed not to occur at or below the dose levels established for individual members of the public. For radionuclides, where the non-stochastic limit was governing in deriving the occupational DAC, the stochastic ALI was used in deriving the corresponding airborne effluent limit in Table II. For this reason, the DAC and airborne effluent limits are not always proportional as was the case in Table 64-23 E.
The air concentration values listed in Table II, Column 1 were derived by one of two methods. For those radionuclides for which the stochastic limit is governing, the occupational stochastic inhalation ALI was divided by two billion four hundred million (2.4 x 109) (ml), relating the inhalation ALI to the DAC, as explained above, and then divided by a factor of three hundred 300. The factor of three hundred 300 includes the following components: a factor of fifty (50) to relate the five one-hundredths (0.05) Sv (five [5] Rem) annual occupational dose limit to the ons (1) mSv (one tenth [0.1] Rem) limit for members of the public, a factor of three (3) to adjust for the difference in exposure time and the inhalation rate for a worker and that for members of the public; and a factor of two (2) to adjust the occupational values, derived for adults, so that they are applicable to other age groups.
For those radionuclides for which submersion, that is external dose, is limiting, the occupational DAC in Table I, Column 3 was divided by two hundred nineteen (219). The factor of two hundred nineteen (219) is composed of a factor of fifty (50), as described above, and a factor of four and thirty eight one-hundredths (4.38) relating occupational exposure for two thousand (2,000) hours per year to full-time exposure (eight thousand seven hundred sixty [8,760] hours per year). Note that an additional factor of tho (2) for age considerations is not warranted in the submersion case.
The water concentrations were derived by taking the most restrictive occupational stochastic oral ingestion ALI and dividing by seventy three million (7.3 x 107). The factor of seventy three million (7.3 x 107 ) (ml) includes the following components: the factors of fifty (50) and two (2) described above and a factor of seven hundred thirty thousand (7.3 x 105 ) (ml) which is the annual water intake of reference man.
Note 2 of this table provides groupings of radionuclides which are applicable to unknown mixtures of radionuclides. These groupings, including occupational inhalation ALIs and DACs, air and water effluent concentrations and releases to sewer, require demonstrating that the most limiting radionuclides in successive classes are absent. The limit for the unknown mixture is defined when the presence of one of the listed radionuclides cannot be definitely excluded as being present either from knowledge of the radionuclide composition of the source or from actual measurements.
Table III "Releases to Sewers"
The monthly average concentrations for release to sanitary sewerage are applicable to the provisions in Subsection 6.34. The concentration values were derived by taking the most restrictive occupational stochastic oral ingestion ALI and dividing by seven million three hundred thousand (7.3 x 106 ) (ml). The factor of seven million three hundred thousand (7.3 x 106 ) (ml) is composed of a factor of seven hundred thirty thousand (7.3 x 105 ) (ml), the annual water intake by reference man, and a factor of ten (10), such that the concentrations, if the sewage released by the registrant were the only source of water ingested by a reference man during a year, would result in a committed effective dose equivalent of five (5) mSv (five tenths 0.5 Rem).
List of Elements Atomic Atomic Name Symbol Number Name Symbol Number Actinium Ac 89 Aluminum A 13 Americium Am 95 Antimony Sb 51 Argon Ar 18 Arsenic As 33 Astatine At 85 Barium Ba 56 Berkelium Bk 97 Beryllium Be 4 Bismuth Bi 83 Bromine Br 35 Cadmium Cd 48 Calcium Ca 20 Californium Cf 98 Carbon C 6 Cerium C 58 Cesium C 55 Chlorine C 17 Chromium C 24 Cobalt C 27 Copper C 29 Curium C 96 Dysprosium D 66 Einsteinium E 99 Erbium E 68 Europium E 63 Fermium F 100 Fluorine F 9 Francium Fr 87 Gadolinium Gd 64 Gallium Ga 31 Germanium Ge 32 Gold Au 79 Hafnium Hf 72 Holmium Ho 67 Hydrogen H 1 Indium In 49 Iodine I 53 Iridium Ir 77 Iron Fe 26 Krypton Kr 36 Lanthanum La 57 Lead Pb 82 Lutetium Lu 71 Magnesium Mg 12 Manganese Mn 25 Mendelevium Md 101 Mercury Hg 80 Molybdenum Mo 42 Neodymium Nd 60 Neptunium Np 93 Nickel Ni 28 Niobium Nb 41 Osmium Os 76 Palladium Pd 46 Phosphorus P 15 Platinum Pt 78 Plutonium Pu 94 Polonium Po 84 Potassium K 19 Praseodymium Pr 59 Promethium Pm 61 Protactinium Pa 91 Radium Ra 88 Radon Rn 86 Rhenium Re 75 Rhodium Rh 45 Rubidium Rb 37 Ruthenium Ru 44 Samarium Sm 62 Scandium Sc 21 Selenium Se 34 Silicon Si 14 Silver Ag 47 Sodium Na 11 Strontium Sr 38 Sulfur S 16 Tantalum Ta 73 Technetium Tc 43 Tellurium Te 52 Terbium Tb 65 Thallium Tl 81 Thorium Th 90 Thulium Tm 69 Tin Sn 50 Titanium Ti 22 Tungsten W 74 Uranium U 92 Vanadium V 23 Xenon Xe 54 Ytterbium Yb 70 Yttrium Y 39 Zinc Zn 30 Zirconium Zr 40 Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml) 1 Hydrogen-3 Water, DAC includes skin absorption 8E+4 8E+4 2E-5 1E-7 1E-3 1E-2 Gas (HT or T2) Submersiona: Use above values as HT and T2 oxidize in air and in the body to HTO. 4 Beryllium-7 W, all compounds except 4E+4 2E+4 9E-6 3E-8 6E-4 6E-3 those given for Y Y, oxides, halides, and nitrates C 2E+4 8E-6 3E-8 C C 4 Beryllium-10 W, see 7Be 1E+3 2E+2 6E-8 2E-10 C C Y, see 7Be C 1E+1 6E-9 2E-11 C C 6 Carbon-11b/ Monoxide C 1E+6 5E-4 2E-6 C C Dioxide C 6E+5 3E-4 9E-7 C C Compounds 4E+5 4E+5 2E-4 6E-7 6E-3 6E-2 6 Carbon-14 Monoxide C 2E+6 7E-4 2E-6 C C Dioxide C 2E+5 9E-5 3E-7 C C Compounds 2E+3 2E+3 1E-6 3E-9 3E-5 3E-4 9 Fluorine-18b/ D, fluorides of H, Li, Na, K, Rb, Cs, and Fr 5E+4 7E+4 3E-5 1E-7 C C W, fluorides of Be, Mg, Ca, Sr, Ba, Ra, Al, Ga, In, Tl, As, Sb, Bi, Fe, Ru, Os, Co, Ni, Pd, Pt, Cu, Ag, Au, Zn, Cd, Hg, Sc, Y, Ti, Zr, V, Nb, Ta, Mn, Tc, and Re C 9E+4 4E-5 1E-7 C C Y, lanthanum fluoride C 8E+4 3E-5 1E-7 C C 11 Sodium-22 D, all compounds 4E+2 6E+2 3E-7 9E-10 6E-6 6E-5 Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml) 11 Sodium-24 D, all compounds 4E+3 5E+3 2E-6 7E-9 5E-5 5E-4 12 Magnesium-28 D, all compounds except those given for W 7E+2 2E+3 7E-7 2E-9 9E-6 9E-5 carbides, halides, and nitrates C 1E+3 5E-7 2E-9 C C 13 Aluminum-26 D, all compounds except those given for W 4E+2 6E+1 3E-8 9E-11 6E-6 6E-5 carbides, halides, and nitrates C 9E+1 4E-8 1E-10 C C 14 Silicon-31 D, all compounds except those given for W and Y 9E+3 3E+4 1E-5 4E-8 1E-4 1E-3 carbides, and nitrates C 3E+4 1E-5 5E-8 C C Y, aluminosilicate glass C 3E+4 1E-5 4E-8 C C 14 Silicon-32 D, see 31Si 2E+3 2E+2 1E-7 3E-10 C C W, see 31Si C 1E+2 5E-8 2E-10 C C Y, see 31Si C 5E+0 2E-9 7E-12 C C 15 Phosphorus-32 D, all compounds except phosphates given for W 6E+2 9E+2 4E-7 1E-9 9E-6 9E-5 W, phosphates of Zn2+, S3+, Mg2+, Fe3+, Bi3+, and lanthanides C 4E+2 2E-7 5E-10 C C 15 Phosphorus-33 D, see 32P 6E+3 8E+3 4E-6 1E-8 8E-5 8E-4 W, see 32P C 3E+3 1E-6 4E-9 C C 16 Sulfur-35 Vapor C 1E+4 6E-6 2E-8 C C D, sulfides and sulfates except those given for W 1E+4 2E+4 7E-6 2E-8 C C (8E+3) C C C 1E-4 1E-3 W, elemental sulfur, 6E+3 sulfides of Sr, Ba, Ge, Sn, Pb, As, Sb, Bi, Cu, Ag, Au, Zn, Cd, Hg, W, and Mo. Sulfates of Ca, Sr, Ba, Ra, As, Sb, and Bi C 2E+3 9E-7 3E-9 C C 17 Chlorine-36 D, chlorides of H, Li, Na, K, Rb, Cs, and Fr 2E+3 2E+3 1E-6 3E-9 2E-5 2E-4 W, chlorides of lanthanides, Be, Mg, Ca, Sr, Ba, Ra, Al, Ga, In, Tl, Ge, Sn, Pb, As, Sb, Bi, Fe, Ru, Os, Co, Rh, Ir, Ni, Pd, Pt, Cu, Ag, Au, Zn, Cd, Hg, Sc, Y, Ti, Zr, Hf, V, Nb, Ta, Cr, Mo, W, Mn, Tc, and Re C 2E+2 1E-7 3E-10 C C Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml)
Chlorine-38b/ D, see 36Cl 2E+4 4E+4 2E-5 6E-8 C (3E+4) C C C 3E-4 3E-3 W, see 36Cl C 5E+4 2E-5 6E-8 C C 17 Chlorine-39b/ D, see 36Cl 2E+4 5E+4 2E-5 7E-8 C C W, see 36Cl C 6E+4 2E-5 8E-8 C C 18 Argon-37 Submersiona C C 1E+0 6E-3 C C 18 Argon-39 Submersiona C C 2E-4 8E-7 C C 18 Argon-41 Submersiona C C 3E-6 1E-8 C C 19 Potassium-40 D, all compounds 3E+2 4E+2 2E-7 6E-10 4E-6 4E-5 19 Potassium-42 D, all compounds 5E+3 5E+3 2E-6 7E-9 6E-5 6E-4 19 Potassium-43 D, all compounds 6E+3 9E+3 4E-6 1E-8 9E-5 9E-4 19 Potassium-44b D, all compounds 2E+4 7E+4 3E-5 9E-8 C C 19 Potassium-45b D, all compounds 3E+4 1E+5 5E-5 2E-7 C C 20 Calcium-41 W, all compounds 3E+3 4E+3 2E-6 C C C (4E+3) (4E+3) C 5E-9 6E-5 6E-4 20 Calcium-45 W, all compounds 2E+3 8E+2 4E-7 1E-9 2E-5 2E-4 20 Calcium-47 W, all compounds 8E+2 9E+2 4E-7 1E-9 1E-5 1E-4 21 Scandium-43 Y, all compounds 7E+3 2E+4 9E-6 3E-8 1E-4 1E-3 21 Scandium-44m Y, all compounds 5E+2 7E+2 3E-7 1E-9 7E-6 7E-5 21 Scandium-44 Y, all compounds 4E+3 1E+4 5E-6 2E-8 5E-5 5E-4 21 Scandium-46 Y, all compounds 9E+2 2E+2 1E-7 3E-10 1E-5 1E-4 21 Scandium-47 Y, all compounds 2E+3 3E+3 1E-6 4E-9 C C 21 Scandium-48 Y, all compounds 8E+2 1E+3 6E-7 2E-9 1E-5 1E-4 21 Scandium-49b/ Y, all compounds 2E+4 5E+4 2E-5 8E-8 3E-4 3E-3 22 Titanium-44 D, all compounds except those given for W and Y 3E+2 1E+1 5E-9 2E-11 4E-6 4E-5 carbides, halides, and nitrates C 3E+1 1E-8 4E-11 C C Y, SrTi0 C 6E+0 2E-9 8E-12 C C Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml) 22 Titanium-45 D, see 44Ti 9E+3 3E+4 1E-5 3E-8 1E-4 1E-3 W, see 44Ti C 4E+4 1E-5 5E-8 C C Y, see 44Ti C 3E+4 1E-5 4E-8 C C 23 Vanadium-47b/ D, all compounds except those given for W 3E+4 8E+4 3E-5 1E-7 C C carbides, and halides C 1E+5 4E-5 1E-7 C C 23 Vanadium-48 D, see 47V 6E+2 1E+3 5E-7 2E-9 9E-6 9E-5 W, see 47V C 6E+2 3E-7 9E-10 C C 23 Vanadium-49 D, see 47V 7E+4 3E+4 1E-5 C C C (9E+4) (3E+4) C 5E-8 1E-3 1E-2 W, see 47V C 2E+4 8E-6 2E-8 C C 24 Chromium-48 D, all compounds except those given for W and Y 6E+3 1E+4 5E-6 2E-8 8E-5 8E-4 W, halides and nitrates C 7E+3 3E-6 1E-8 C C Y, oxides and hydroxides C 7E+3 3E-6 1E-8 C C 24 Chromium-49b/ D, see 48Cr 3E+4 8E+4 4E-5 1E-7 4E-4 4E-3 W, see 48Cr C 1E+5 4E-5 1E-7 C C Y, see 48Cr C 9E+4 4E-5 1E-7 C C 24 Chromium-51 D, see 48Cr 4E+4 5E+4 2E-5 6E-8 5E-4 5E-3 W, see 48Cr C 2E+4 1E-5 3E-8 C C Y, see 48Cr C 2E+4 8E-6 3E-8 C C 25 Manganese-51b/ D, all compounds except those given for W 2E+4 5E+4 2E-5 7E-8 3E-4 3E-3 halides, and nitrates C 6E+4 3E-5 8E-8 C C 25 Manganese-52mb D, see 51Mn 3E+4 9E+4 4E-5 1E-7 C C W, see 51Mn C 1E+5 4E-5 1E-7 C C 25 Manganese-52 D, see 51Mn 7E+2 1E+3 5E-7 2E-9 1E-5 1E-4 W, see 51Mn C 9E+2 4E-7 1E-9 C C 25 Manganese-53 D, see 51Mn 5E+4 1E+4 5E-6 C 7E-4 7E-3 C (2E+4) C 3E-8 C C W, see 51Mn C 1E+4 5E-6 2E-8 C C 25 Manganese-54 D, see 51Mn 2E+3 9E+2 4E-7 1E-9 3E-5 3E-4 W, see 51Mn C 8E+2 3E-7 1E-9 C C 25 Manganese-56 D, see 51Mn 5E+3 2E+4 6E-6 2E-8 7E-5 7E-4 W, see 51Mn C 2E+4 9E-6 3E-8 C C 26 Iron-52 D, all compounds except those given for W 9E+2 3E+3 1E-6 4E-9 1E-5 1E-4 and halides C 2E+3 1E-6 3E-9 C C 26 Iron-55 D, see 52Fe 9E+3 2E+3 8E-7 3E-9 1E-4 1E-3 W, see 52Fe C 4E+3 2E-6 6E-9 C C Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml) 26 Iron-59 D, see 52Fe 8E+2 3E+2 1E-7 5E-10 1E-5 1E-4 W, see 52Fe C 5E+2 2E-7 7E-10 C C 26 Iron-60 D, see 52Fe 3E+1 6E+0 3E-9 9E-12 4E-7 4E-6 W, see 52Fe C 2E+1 8E-9 3E-11 C C 27 Cobalt-55 W, all compounds except those given for Y 1E+3 3E+3 1E-6 4E-9 2E-5 2E-4 halides, and nitrates C 3E+3 1E-6 4E-9 C C 27 Cobalt-56 W, see 55Co 5E+2 3E+2 1E-7 4E-10 6E-6 6E-5 Y, see 55Co 4E+2 2E+2 8E-8 3E-10 C C 27 Cobalt-57 W, see 55Co 8E+3 3E+3 1E-6 4E-9 6E-5 6E-4 Y, see 55Co 4E+3 7E+2 3E-7 9E-10 C C 27 Cobalt-58m W, see 55Co 6E+4 9E+4 4E-5 1E-7 8E-4 8E-3 Y, see 55Co C 6E+4 3E-5 9E-8 C C 27 Cobalt-58 W, see 55Co 2E+3 1E+3 5E-7 2E-9 2E-5 2E-4 Y, see 55Co 1E+3 7E+2 3E-7 1E-9 C C 27 Cobalt-60mb W, see 55Co 1E+6 4E+6 2E-3 6E-6 C C (1E+6) C C C 2E-2 2E-1 Y, see 55Co C 3E+6 1E-3 4E-6 C C 27 Cobalt-60 W, see 55Co 5E+2 2E+2 7E-8 2E-10 3E-6 3E-5 Y, see 55Co 2E+2 3E+1 1E-8 5E-11 C C 27 Cobalt-61b/ W, see 55Co 2E+4 6E+4 3E-5 9E-8 3E-4 3E-3 Y, see 55Co 2E+4 6E+4 2E-5 8E-8 C C 27 Cobalt-62mb/ W, see 55Co 4E+4 2E+5 7E-5 2E-7 C C Y, see 55Co C 2E+5 6E-5 2E-7 C C 28 Nickel-56 D, all compounds except those given for W 1E+3 2E+3 8E-7 3E-9 2E-5 2E-4 and carbides C 1E+3 5E-7 2E-9 C C Vapor C 1E+3 5E-7 2E-9 C C 28 Nickel-57 D, see 56Ni 2E+3 5E+3 2E-6 7E-9 2E-5 2E-4 W, see 56Ni C 3E+3 1E-6 4E-9 C C Vapor C 6E+3 3E-6 9E-9 C C 28 Nickel-59 D, see 56Ni 2E+4 4E+3 2E-6 5E-9 3E-4 3E-3 W, see 56Ni C 7E+3 3E-6 1E-8 C C Vapor C 2E+3 8E-7 3E-9 C C 28 Nickel-63 D, see 56Ni 9E+3 2E+3 7E-7 2E-9 1E-4 1E-3 W, see 56Ni C 3E+3 1E-6 4E-9 C C Vapor C 8E+2 3E-7 1E-9 C C 28 Nickel-65 D, see 56Ni 8E+3 2E+4 1E-5 3E-8 1E-4 1E-3 W, see 56Ni C 3E+4 1E-5 4E-8 C C Vapor C 2E+4 7E-6 2E-8 C C Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml) 28 Nickel-66 D, see 56Ni 4E+2 2E+3 7E-7 2E-9 C C (5E+2) C C C 6E-6 6E-5 W, see 56Ni C 6E+2 3E-7 9E-10 C C Vapor C 3E+3 1E-6 4E-9 C C 29 Copper-60b/ D, all compounds except those given for W and Y 3E+4 9E+4 4E-5 1E-7 C C W, sulfides, halides, and nitrates C 1E+5 5E-5 2E-7 C C Y, oxides and hydroxides C 1E+5 4E-5 1E-7 C C 29 Copper-61 D, see 60Cu 1E+4 3E+4 1E-5 4E-8 2E-4 2E-3 W, see 60Cu C 4E+4 2E-5 6E-8 C C Y, see 60Cu C 4E+4 1E-5 5E-8 C C 29 Copper-64 D, see 60Cu 1E+4 3E+4 1E-5 4E-8 2E-4 2E-3 W, see 60Cu C 2E+4 1E-5 3E-8 C C Y, see 60Cu C 2E+4 9E-6 3E-8 C C 29 Copper-67 D, see 60Cu 5E+3 8E+3 3E-6 1E-8 6E-5 6E-4 W, see 60Cu C 5E+3 2E-6 7E-9 C C Y, see 60Cu C 5E+3 2E-6 6E-9 C C 30 Zinc-62 Y, all compounds 1E+3 3E+3 1E-6 4E-9 2E-5 2E-4 30 Zinc-63b/ Y, all compounds 2E+4 7E+4 3E-5 9E-8 C C (3E+4) C C C 3E-4 3E-3 30 Zinc-65 Y, all compounds 4E+2 3E+2 1E-7 4E-10 5E-6 5E-5 30 Zinc-69m Y, all compounds 4E+3 7E+3 3E-6 1E-8 6E-5 6E-4 30 Zinc-69b/ Y, all compounds 6E+4 1E+5 6E-5 2E-7 8E-4 8E-3 30 Zinc-71m Y, all compounds 6E+3 2E+4 7E-6 2E-8 8E-5 8E-4 30 Zinc-72 Y, all compounds 1E+3 1E+3 5E-7 2E-9 1E-5 1E-4 31 Gallium-65b D, all compounds except those given for W 5E+4 2E+5 7E-5 2E-7 C C (6E+4) C C C 9E-4 9E-3 carbides, halides, and nitrates C 2E+5 8E-5 3E-7 C C 31 Gallium-66 D, see 65Ga 1E+3 4E+3 1E-6 5E-9 1E-5 1E-4 W, see 65Ga C 3E+3 1E-6 4E-9 C C 31 Gallium-67 D, see 65Ga 7E+3 1E+4 6E-6 2E-8 1E-4 1E-3 W, see 65Ga C 1E+4 4E-6 1E-8 C C 31 Gallium-68b/ D, see 65Ga 2E+4 4E+4 2E-5 6E-8 2E-4 2E-3 W, see 65Ga C 5E+4 2E-5 7E-8 C C 31 Gallium-70b/ D, see 65Ga 5E+4 2E+5 7E-5 2E-7 C C W, see 65Ga C 2E+5 8E-5 3E-7 C C Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml) 31 Gallium-72 D, see 65Ga 1E+3 4E+3 1E-6 5E-9 2E-5 2E-4 W, see 65Ga C 3E+3 1E-6 4E-9 C C 31 Gallium-73 D, see 65Ga 5E+3 2E+4 6E-6 2E-8 7E-5 7E-4 W, see 65Ga C 2E+4 6E-6 2E-8 C C 32 Germanium-66 D, all compounds except those given for W 2E+4 3E+4 1E-5 4E-8 3E-4 3E-3 W, oxides, sulfides, and halides C 2E+4 8E-6 3E-8 C C 32 Germanium-67b/ D, see 66Ge 3E+4 9E+4 4E-5 1E-7 C C W, see 66Ge C 1E+5 4E-5 1E-7 C C 32 Germanium-68 D, see 66Ge 5E+3 4E+3 2E-6 5E-9 6E-5 6E-4 W, see 66Ge C 1E+2 4E-8 1E-10 C C 32 Germanium-69 D, see 66Ge 1E+4 2E+4 6E-6 2E-8 2E-4 2E-3 W, see 66Ge C 8E+3 3E-6 1E-8 C C 32 Germanium-71 D, see 66Ge 5E+5 4E+5 2E-4 6E-7 7E-3 7E-2 W, see 66Ge C 4E+4 2E-5 6E-8 C C 32 Germanium-75b D, see 66Ge 4E+4 8E+4 3E-5 1E-7 C C (7E+4) C C C 9E-4 9E-3 W, see 66Ge C 8E+4 4E-5 1E-7 C C 32 Germanium-77 D, see 66Ge 9E+3 1E+4 4E-6 1E-8 1E-4 1E-3 W, see 66Ge C 6E+3 2E-6 8E-9 C C 32 Germanium-78b/ D, see 66Ge 2E+4 2E+4 9E-6 3E-8 C C (2E+4) C C C 3E-4 3E-3 W, see 66Ge C 2E+4 9E-6 3E-8 C C 33 Arsenic-69b/ W, all compounds 3E+4 1E+5 5E-5 2E-7 C C 33 Arsenic-70b/ W, all compounds 1E+4 5E+4 2E-5 7E-8 2E-4 2E-3 33 Arsenic-71 W, all compounds 4E+3 5E+3 2E-6 6E-9 5E-5 5E-4 33 Arsenic-72 W, all compounds 9E+2 1E+3 6E-7 2E-9 1E-5 1E-4 33 Arsenic-73 W, all compounds 8E+3 2E+3 7E-7 2E-9 1E-4 1E-3 33 Arsenic-74 W, all compounds 1E+3 8E+2 3E-7 1E-9 2E-5 2E-4 33 Arsenic-76 W, all compounds 1E+3 1E+3 6E-7 2E-9 1E-5 1E-4 33 Arsenic-77 W, all compounds 4E+3 5E+3 2E-6 7E-9 C C (5E+3) C C C 6E-5 6E-4 33 Arsenic-78b/ W, all compounds 8E+3 2E+4 9E-6 3E-8 1E-4 1E-3 Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml) 34 Selenium-70b D, all compounds except those given for W 2E+4 4E+4 2E-5 5E-8 1E-4 1E-3 carbides, and elemental Se 1E+4 4E+4 2E-5 6E-8 C C 34 Selenium-73mb D, see 70Se 6E+4 2E+5 6E-5 2E-7 4E-4 4E-3 W, see 70Se 3E+4 1E+5 6E-5 2E-7 C C 34 Selenium-73 D, see 70Se 3E+3 1E+4 5E-6 2E-8 4E-5 4E-4 W, see 70Se C 2E+4 7E-6 2E-8 C C 34 Selenium-75 D, see 70Se 5E+2 7E+2 3E-7 1E-9 7E-6 7E-5 W, see 70Se C 6E+2 3E-7 8E-10 C C 34 Selenium-79 D, see 70Se 6E+2 8E+2 3E-7 1E-9 8E-6 8E-5 W, see 70Se C 6E+2 2E-7 8E-10 C C 34 Selenium-81mb/ D, see 70Se 4E+4 7E+4 3E-5 9E-8 3E-4 3E-3 W, see 70Se 2E+4 7E+4 3E-5 1E-7 C C 34 Selenium-81b/ D, see 70Se 6E+4 2E+5 9E-5 3E-7 C C (8E+4) C C C 1E-3 1E-2 W, see 70Se C 2E+5 1E-4 3E-7 C C 34 Selenium-83b/ D, see 70Se 4E+4 1E+5 5E-5 2E-7 4E-4 4E-3 W, see 70Se 3E+4 1E+5 5E-5 2E-7 C C 35 Bromine-74mb/ D, bromides of H, Li, Na, K, Rb, Cs, and Fr 1E+4 4E+4 2E-5 5E-8 C C (2E+4) C C C 3E-4 3E-3 W, bromides of lanthanides, Be, Mg, Ca, Sr, Ba, Ra, Al, Ga, In, Tl, Ge, Sn, Pb, As, Sb, Bi, Fe, Ru, Os, Co, Rh, Ir, Ni, Pd, Pt, Cu, Ag, Au, Zn, Cd, Hg, Sc, Y, Ti, Zr, Hf, V, Nb, Ta, Mn, Tc, and Re C 4E+4 2E-5 6E-8 C C 35 Bromine-74b D, see 74mBr 2E+4 7E+4 3E-5 1E-7 C C W, see 74mBr C 8E+4 4E-5 1E-7 C C 35 Bromine-75b/ D, see 74mBr 3E+4 5E+4 2E-5 7E-8 C C W, see 74mBr C 5E+4 2E-5 7E-8 C C 35 Bromine-76 D, see 74mBr 4E+3 5E+3 2E-6 7E-9 5E-5 5E-4 W, see 74mBr C 4E+3 2E-6 6E-9 C C 35 Bromine-77 D, see 74mBr 2E+4 2E+4 1E-5 3E-8 2E-4 2E-3 W, see 74mBr C 2E+4 8E-6 3E-8 C C 35 Bromine-80m D, see 74mBr 2E+4 2E+4 7E-6 2E-8 3E-4 3E-3 W, see 74mBr C 1E+4 6E-6 2E-8 C C Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml) 35 Bromine-80b/ D, see 74mBr 5E+4 2E+5 8E-5 3E-7 C C W, see 74mBr C 2E+5 9E-5 3E-7 C C 35 Bromine-82 D, see 74mBr 3E+3 4E+3 2E-6 6E-9 4E-5 4E-4 W, see 74mBr C 4E+3 2E-6 5E-9 C C 35 Bromine-83 D, see 74mBr 5E+4 6E+4 3E-5 9E-8 C C (7E+4) C C C 9E-4 9E-3 W, see 74mBr C 6E+4 3E-5 9E-8 C C 35 Bromine-84b/ D, see 74mBr 2E+4 6E+4 2E-5 8E-8 C C W, see 74mBr C 6E+4 3E-5 9E-8 C C 36 Krypton-74b/ Submersiona/ C C 3E-6 1E-8 C C 36 Krypton-76 Submersiona/ C C 9E-6 4E-8 C C 36 Krypton-77b Submersiona/ C C 4E-6 2E-8 C C 36 Krypton-79 Submersiona/ C C 2E-5 7E-8 C C 36 Krypton-81 Submersiona/ C C 7E-4 3E-6 C C 36 Krypton-83mb Submersiona/ C C 1E-2 5E-5 C C 36 Krypton-85m Submersiona/ C C 2E-5 1E-7 C C 36 Krypton-85 Submersiona/ C C 1E-4 7E-7 C C 36 Krypton-87b Submersiona/ C C 5E-6 2E-8 C C 36 Krypton-88 Submersiona/ C C 2E-6 9E-9 C C 37 Rubidium-79b D, all compounds 4E+4 1E+5 5E-5 2E-7 C C 37 Rubidium-81mb/ D, all compounds 2E+5 3E+5 1E-4 5E-7 C C (3E+5) C C C 4E-3 4E-2 37 Rubidium-81 D, all compounds 4E+4 5E+4 2E-5 7E-8 5E-4 5E-3 37 Rubidium-82m D, all compounds 1E+4 2E+4 7E-6 2E-8 2E-4 2E-3 37 Rubidium-83 D, all compounds 6E+2 1E+3 4E-7 1E-9 9E-6 9E-5 37 Rubidium-84 D, all compounds 5E+2 8E+2 3E-7 1E-9 7E-6 7E-5 37 Rubidium-86 D, all compounds 5E+2 8E+2 3E-7 1E-9 7E-6 7E-5 37 Rubidium-87 D, all compounds 1E+3 2E+3 6E-7 2E-9 1E-5 1E-4 37 Rubidium-88b/ D, all compounds 2E+4 6E+4 3E-5 9E-8 C C (3E+4) - C C 4E-4 4E-3 37 Rubidium-89b/ D, all compounds 4E+4 1E+5 6E-5 2E-7 C C (6E+4) - C C 9E-4 9E-3 Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml) 38 Strontium-80b/ D, all soluble compounds except SrTiO3 4E+3 1E+4 5E-6 2E-8 6E-5 6E-4 Y, all insoluble compounds and SrTi03 C 1E+4 5E-6 2E-8 C C 38 Strontium-81b D, see 80Sr 3E+4 8E+4 3E-5 1E-7 3E-4 3E-3 Y, see 80Sr 2E+4 8E+4 3E-5 1E-7 C C 38 Strontium-82 D, see 80Sr 3E+2 4E+2 2E-7 6E-10 C C (2E+2) C C C 3E-6 3E-5 Y, see 80Sr 2E+2 9E+1 4E-8 1E-10 C C 38 Strontium-83 D, see 80Sr 3E+3 7E+3 3E-6 1E-8 3E-5 3E-4 Y, see 80Sr 2E+3 4E+3 1E-6 5E-9 C C 38 Strontium-85mb/ D, see 80Sr 2E+5 6E+5 3E-4 9E-7 3E-3 3E-2 Y, see 80Sr C 8E+5 4E-4 1E-6 C C 38 Strontium-85 D, see 80Sr 3E+3 3E+3 1E-6 4E-9 4E-5 4E-4 Y, see 80Sr C 2E+3 6E-7 2E-9 C C 38 Strontium-87m D, see 80Sr 5E+4 1E+5 5E-5 2E-7 6E-4 6E-3 Y, see 80Sr 4E+4 2E+5 6E-5 2E-7 C C 38 Strontium-89 D, see 80Sr 6E+2 8E+2 4E-7 1E-9 C C Y, see 80Sr 5E+2 1E+2 6E-8 2E-10 C C 38 Strontium-90 D, see 80Sr 3E+1 2E+1 8E-9 C C C (4E+1) (2E+1) C 3E-11 5E-7 5E-6 Y, see 80Sr C 4E+0 2E-9 6E-12 C C 38 Strontium-91 D, see 80Sr 2E+3 6E+3 2E-6 8E-9 2E-5 2E-4 Y, see 80Sr C 4E+3 1E-6 5E-9 C C 38 Strontium-92 D, see 80Sr 3E+3 9E+3 4E-6 1E-8 4E-5 4E-4 Y, see 80Sr C 7E+3 3E-6 9E-9 C C 39 Yttrium-86mb/ W, all compounds except those given for Y 2E+4 6E+4 2E-5 8E-8 3E-4 3E-3 Y, oxides and hydroxides C 5E+4 2E-5 8E-8 C C 39 Yttrium-86 W, see 86mY 1E+3 3E+3 1E-6 5E-9 2E-5 2E-4 Y, see 86mY C 3E+3 1E-6 5E-9 C C 39 Yttrium-87 W, see 86mY 2E+3 3E+3 1E-6 5E-9 3E-5 3E-4 Y, see 86mY C 3E+3 1E-6 5E-9 C C 39 Yttrium-88 W, see 86mY 1E+3 3E+2 1E-7 3E-10 1E-5 1E-4 Y, see 86mY C 2E+2 1E-7 3E-10 C C 39 Yttrium-90m W, see 86mY 8E+3 1E+4 5E-6 2E-8 1E-4 1E-3 Y, see 86mY C 1E+4 5E-6 2E-8 C C 39 Yttrium-90 W, see 86mY 4E+2 7E+2 3E-7 9E-10 C C (5E+2) C C C 7E-6 7E-5 Y, see 86mY C 6E+2 3E-7 9E-10 C C 39 Yttrium-91mb W, see 86mY 1E+5 2E+5 1E-4 3E-7 2E-3 2E-2 Y, see 86mY C 2E+5 7E-5 2E-7 C C Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml) 39 Yttrium-91 W, see 86mY 5E+2 2E+2 7E-8 2E-10 C C Y, see 86mY C 1E+2 5E-8 2E-10 C C 39 Yttrium-92 W, see 86mY 3E+3 9E+3 4E-6 1E-8 4E-5 4E-4 Y, see 86mY C 8E+3 3E-6 1E-8 C C 39 Yttrium-93 W, see 86mY 1E+3 3E+3 1E-6 4E-9 2E-5 2E-4 Y, see 86mY C 2E+3 1E-6 3E-9 C C 39 Yttrium-94b/ W, see 86mY 2E+4 8E+4 3E-5 1E-7 C C Y, see 86mY C 8E+4 3E-5 1E-7 C C 39 Yttrium-95b/ W, see 86mY 4E+4 2E+5 6E-5 2E-7 C C Y, see 86mY C 1E+5 6E-5 2E-7 C C 40 Zirconium-86 D, all compounds except those given for W and Y 1E+3 4E+3 2E-6 6E-9 2E-5 2E-4 halides, and nitrates C 3E+3 1E-6 4E-9 C C Y, carbide C 2E+3 1E-6 3E-9 C C 40 Zirconium-88 D, see 86Zr 4E+3 2E+2 9E-8 3E-10 5E-5 5E-4 W, see 86Zr C 5E+2 2E-7 7E-10 C C Y, see 86Zr C 3E+2 1E-7 4E-10 C C 40 Zirconium-89 D, see 86Zr 2E+3 4E+3 1E-6 5E-9 2E-5 2E-4 W, see 86Zr C 2E+3 1E-6 3E-9 C C Y, see 86Zr C 2E+3 1E-6 3E-9 C C 40 Zirconium-93 D, see 86Zr 1E+3 6E+0 3E-9 C C C (3E+3) (2E+1) C 2E-11 4E-5 4E-4 W, see 86Zr C 2E+1 1E-8 C C C C (6E+1) C 9E-11 C C Y, see 86Zr C 6E+1 2E-8 C C C C (7E+1) C 9E-11 C C 40 Zirconium-95 D, see 86Zr 1E+3 1E+2 5E-8 C 2E-5 2E-4 C (3E+2) C 4E-10 C C W, see 86Zr C 4E+2 2E-7 5E-10 C C Y, see 86Zr C 3E+2 1E-7 4E-10 C C 40 Zirconium-97 D, see 86Zr 6E+2 2E+3 8E-7 3E-9 9E-6 9E-5 W, see 86Zr C 1E+3 6E-7 2E-9 C C Y, see 86Zr C 1E+3 5E-7 2E-9 C C 41 Niobium-88b W, all compounds except those given for Y 5E+4 2E+5 9E-5 3E-7 C C Y, oxides and hydroxides C 2E+5 9E-5 3E-7 C C 41 Niobium-89b W, see 88Nb 1E+4 4E+4 2E-5 6E-8 1E-4 1E-3 (66 min)
Y, see 88Nb C 4E+4 2E-5 5E-8 C C Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml) 41 Niobium-89 W, see 88Nb 5E+3 2E+4 8E-6 3E-8 7E-5 7E-4 (122 min)
Y, see 88Nb C 2E+4 6E-6 2E-8 C C 41 Niobium-90 W, see 88Nb 1E+3 3E+3 1E-6 4E-9 1E-5 1E-4 Y, see 88Nb C 2E+3 1E-6 3E-9 C C 41 Niobium-93m W, see 88Nb 9E+3 2E+3 8E-7 3E-9 C C (1E+4) C C C 2E-4 2E-3 Y, see 88Nb C 2E+2 7E-8 2E-10 C C 41 Niobium-94 W, see 88Nb 9E+2 2E+2 8E-8 3E-10 1E-5 1E-4 Y, see 88Nb C 2E+1 6E-9 2E-11 C C 41 Niobium-95m W, see 88Nb 2E+3 3E+3 1E-6 4E-9 C C Y, see 88Nb C 2E+3 9E-7 3E-9 C C 41 Niobium-95 W, see 88Nb 2E+3 1E+3 5E-7 2E-9 3E-5 3E-4 Y, see 88Nb C 1E+3 5E-7 2E-9 C C 41 Niobium-96 W, see 88Nb 1E+3 3E+3 1E-6 4E-9 2E-5 2E-4 Y, see 88Nb C 2E+3 1E-6 3E-9 C C 41 Niobium-97b/ W, see 88Nb 2E+4 8E+4 3E-5 1E-7 3E-4 3E-3 Y, see 88Nb C 7E+4 3E-5 1E-7 C C 41 Niobium-98b/ W, see 88Nb 1E+4 5E+4 2E-5 8E-8 2E-4 2E-3 Y, see 88Nb C 5E+4 2E-5 7E-8 C C 42 Molybdenum-90 D, all compounds except those given for Y 4E+3 7E+3 3E-6 1E-8 3E-5 3E-4 and MoS2 2E+3 5E+3 2E-6 6E-9 C C 42 Molybdenum-93m D, see 90Mo 9E+3 2E+4 7E-6 2E-8 6E-5 6E-4 Y, see 90Mo 4E+3 1E+4 6E-6 2E-8 C C 42 Molybdenum-93 D, see 90Mo 4E+3 5E+3 2E-6 8E-9 5E-5 5E-4 Y, see 90Mo 2E+4 2E+2 8E-8 2E-10 C C 42 Molybdenum-99 D, see 90Mo 2E+3 3E+3 1E-6 4E-9 C C Y, see 90Mo 1E+3 1E+3 6E-7 2E-9 C C 42 Molybdenum-101b D, see 90Mo 4E+4 1E+5 6E-5 2E-7 C C Y, see 90Mo C 1E+5 6E-5 2E-7 C C 43 Technetium-93mb D, all compounds except those given for W 7E+4 2E+5 6E-5 2E-7 1E-3 1E-2 halides, and nitrates C 3E+5 1E-4 4E-7 C C 43 Technetium-93 D, see 93mTc 3E+4 7E+4 3E-5 1E-7 4E-4 4E-3 W, see 93mTc C 1E+5 4E-5 1E-7 C C Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml) 43 Technetium-94mb D, see 93mTc 2E+4 4E+4 2E-5 6E-8 3E-4 3E-3 W, see 93mTc C 6E+4 2E-5 8E-8 C C 43 Technetium-94 D, see 93mTc 9E+3 2E+4 8E-6 3E-8 1E-4 1E-3 W, see 93mTc C 2E+4 1E-5 3E-8 C C 43 Technetium-95m D, see 93mTc 4E+3 5E+3 2E-6 8E-9 5E-5 5E-4 W, see 93mTc C 2E+3 8E-7 3E-9 C C 43 Technetium-95 D, see 93mTc 1E+4 2E+4 9E-6 3E-8 1E-4 1E-3 W, see 93mTc C 2E+4 8E-6 3E-8 C C 43 Technetium-96mb/ D, see 93mTc 2E+5 3E+5 1E-4 4E-7 2E-3 2E-2 W, see 93mTc C 2E+5 1E-4 3E-7 C C 43 Technetium-96 D, see 93mTc 2E+3 3E+3 1E-6 5E-9 3E-5 3E-4 W, see 93mTc C 2E+3 9E-7 3E-9 C C 43 Technetium-97m D, see 93mTc 5E+3 7E+3 3E-6 C 6E-5 6E-4 C (7E+3) C 1E-8 C C W, see 93mTc C 1E+3 5E-7 2E-9 C C 43 Technetium-97 D, see 93mTc 4E+4 5E+4 2E-5 7E-8 5E-4 5E-3 W, see 93mTc C 6E+3 2E-6 8E-9 C C 43 Technetium-98 D, see 93mTc 1E+3 2E+3 7E-7 2E-9 1E-5 1E-4 W, see 93mTc C 3E+2 1E-7 4E-10 C C 43 Technetium-99m D, see 93mTc 8E+4 2E+5 6E-5 2E-7 1E-3 1E-2 W, see 93mTc C 2E+5 1E-4 3E-7 C C 43 Technetium-99 D, see 93mTc 4E+3 5E+3 2E-6 C 6E-5 6E-4 C (6E+3) C 8E-9 C C W, see 93mTc C 7E+2 3E-7 9E-10 C C 43 Technetium-101b/ D, see 93mTc 9E+4 3E+5 1E-4 5E-7 C C (1E+5) C C C 2E-3 2E-2 W, see 93mTc C 4E+5 2E-4 5E-7 C C 43 Technetium-104b/ D, see 93mTc 2E+4 7E+4 3E-5 1E-7 C C W, see 93mTc C 9E+4 4E-5 1E-7 C C 44 Ruthenium-94b/ D, all compounds except those given for W and Y 2E+4 4E+4 2E-5 6E-8 2E-4 2E-3 W, halides C 6E+4 3E-5 9E-8 C C Y, oxides and hydroxides C 6E+4 2E-5 8E-8 C C 44 Ruthenium-97 D, see 94Ru 8E+3 2E+4 8E-6 3E-8 1E-4 1E-3 W, see 94Ru C 1E+4 5E-6 2E-8 C C Y, see 94Ru C 1E+4 5E-6 2E-8 C C 44 Ruthenium-103 D, see 94Ru 2E+3 2E+3 7E-7 2E-9 3E-5 3E-4 W, see 94Ru C 1E+3 4E-7 1E-9 C C Y, see 94Ru C 6E+2 3E-7 9E-10 C C 44 Ruthenium-105 D, see 94Ru 5E+3 1E+4 6E-6 2E-8 7E-5 7E-4 W, see 94Ru C 1E+4 6E-6 2E-8 C C Y, see 94Ru C 1E+4 5E-6 2E-8 C C Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml) 44 Ruthenium-106 D, see 94Ru 2E+2 9E+1 4E-8 1E-10 C C (2E+2) C C C 3E-6 3E-5 W, see 94Ru C 5E+1 2E-8 8E-11 C C Y, see 94Ru C 1E+1 5E-9 2E-11 C C 45 Rhodium-99m D, all compounds except those given for W and Y 2E+4 6E+4 2E-5 8E-8 2E-4 2E-3 W, halides C 8E+4 3E-5 1E-7 C C Y, oxides and hydroxides C 7E+4 3E-5 9E-8 C C 45 Rhodium-99 D, see 99mRh 2E+3 3E+3 1E-6 4E-9 3E-5 3E-4 W, see 99mRh C 2E+3 9E-7 3E-9 C C Y, see 99mRh C 2E+3 8E-7 3E-9 C C 45 Rhodium-100 D, see 99mRh 2E+3 5E+3 2E-6 7E-9 2E-5 2E-4 W, see 99mRh C 4E+3 2E-6 6E-9 C C Y, see 99mRh C 4E+3 2E-6 5E-9 C C 45 Rhodium-101m D, see 99mRh 6E+3 1E+4 5E-6 2E-8 8E-5 8E-4 W, see 99mRh C 8E+3 4E-6 1E-8 C C Y, see 99mRh C 8E+3 3E-6 1E-8 C C 45 Rhodium-101 D, see 99mRh 2E+3 5E+2 2E-7 7E-10 3E-5 3E-4 W, see 99mRh C 8E+2 3E-7 1E-9 C C Y, see 99mRh C 2E+2 6E-8 2E-10 C C 45 Rhodium-102m D, see 99mRh 1E+3 5E+2 2E-7 7E-10 C C W, see 99mRh C 4E+2 2E-7 5E-10 C C Y, see 99mRh C 1E+2 5E-8 2E-10 C C 45 Rhodium-102 D, see 99mRh 6E+2 9E+1 4E-8 1E-10 8E-6 8E-5 W, see 99mRh C 2E+2 7E-8 2E-10 C C Y, see 99mRh C 6E+1 2E-8 8E-11 C C 45 Rhodium-103mb D, see 99mRh 4E+5 1E+6 5E-4 2E-6 6E-3 6E-2 W, see 99mRh C 1E+6 5E-4 2E-6 C C Y, see 99mRh C 1E+6 5E-4 2E-6 C C 45 Rhodium-105 D, see 99mRh 4E+3 1E+4 5E-6 2E-8 C C (4E+3) C C C 5E-5 5E-4 W, see 99mRh C 6E+3 3E-6 9E-9 C C Y, see 99mRh C 6E+3 2E-6 8E-9 C C 45 Rhodium-106m D, see 99mRh 8E+3 3E+4 1E-5 4E-8 1E-4 1E-3 W, see 99mRh C 4E+4 2E-5 5E-8 C C Y, see 99mRh C 4E+4 1E-5 5E-8 C C 45 Rhodium-107b/ D, see 99mRh 7E+4 2E+5 1E-4 3E-7 C C W, see 99mRh C 3E+5 1E-4 4E-7 C C Y, see 99mRh C 3E+5 1E-4 3E-7 C C 46 Palladium-100 D, all compound44s except those given for W and4 Y 1E+3 1E+3 6E-7 2E-9 2E-5 2E-4 W, nitrates C 1E+3 5E-7 2E-9 C C Y, oxides and hydroxides C 1E+3 6E-7 2E-9 C C Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml) 46 Palladium-101 D, see 100Pd 1E+4 3E+4 1E-5 5E-8 2E-4 2E-3 W, see 100Pd C 3E+4 1E-5 5E-8 C C Y, see 100Pd C 3E+4 1E-5 4E-8 C C 46 Palladium-103 D, see 100Pd 6E+3 6E+3 3E-6 9E-9 C C (7E+3) C C C 1E-4 1E-3 W, see 100Pd C 4E+3 2E-6 6E-9 C C Y, see 100Pd C 4E+3 1E-6 5E-9 C C 46 Palladium-107 D, see 100Pd 3E+4 2E+4 9E-6 C C C LLI wall Kidneys (4E+4) (2E+4) C 3E-8 5E-4 5E-3 W, see 100Pd C 7E+3 3E-6 1E-8 C C Y, see 100Pd C 4E+2 2E-7 6E-10 C C 46 Palladium-109 D, see 100Pd 2E+3 6E+3 3E-6 9E-9 3E-5 3E-4 W, see 100Pd C 5E+3 2E-6 8E-9 C C Y, see 100Pd C 5E+3 2E-6 6E-9 C C 47 Silver-102b D, all compounds except those given for W and Y 5E+4 2E+5 8E-5 2E-7 C C (6E+4) C C C 9E-4 9E-3 W, nitrates and sulfides C 2E+5 9E-5 3E-7 C C Y, oxides and hydroxides C 2E+5 8E-5 3E-7 C C 47 Silver-103b D, see 102Ag 4E+4 1E+5 4E-5 1E-7 5E-4 5E-3 W, see 102Ag C 1E+5 5E-5 2E-7 C C Y, see 102Ag C 1E+5 5E-5 2E-7 C C 47 Silver-104mb D, see 102Ag 3E+4 9E+4 4E-5 1E-7 4E-4 4E-3 W, see 102Ag C 1E+5 5E-5 2E-7 C C Y, see 102Ag C 1E+5 5E-5 2E-7 C C 47 Silver-104b D, see 102Ag 2E+4 7E+4 3E-5 1E-7 3E-4 3E-3 W, see 102Ag C 1E+5 6E-5 2E-7 C C Y, see 102Ag C 1E+5 6E-5 2E-7 C C 47 Silver-105 D, see 102Ag 3E+3 1E+3 4E-7 1E-9 4E-5 4E-4 W, see 102Ag C 2E+3 7E-7 2E-9 C C Y, see 102Ag C 2E+3 7E-7 2E-9 C C 47 Silver-106m D, see 102Ag 8E+2 7E+2 3E-7 1E-9 1E-5 1E-4 W, see 102Ag C 9E+2 4E-7 1E-9 C C Y, see 102Ag C 9E+2 4E-7 1E-9 C C 47 Silver-106b D, see 102Ag 6E+4 2E+5 8E-5 3E-7 C C (6E+4) C C C 9E-4 9E-3 W, see 102Ag C 2E+5 9E-5 3E-7 C C Y, see 102Ag C 2E+5 8E-5 3E-7 C C 47 Silver-108m D, see 102Ag 6E+2 2E+2 8E-8 3E-10 9E-6 9E-5 W, see 102Ag C 3E+2 1E-7 4E-10 C C Y, see 102Ag C 2E+1 1E-8 3E-11 C C 47 Silver-110m D, see 102Ag 5E+2 1E+2 5E-8 2E-10 6E-6 6E-5 W, see 102Ag C 2E+2 8E-8 3E-10 C C Y, see 102Ag C 9E+1 4E-8 1E-10 C C Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml) 47 Silver-111 D, see 102Ag 9E+2 2E+3 6E-7 C C C LLI wall Liver (1E+3) (2E+3) C 2E-9 2E-5 2E-4 W, see 102Ag C 9E+2 4E-7 1E-9 C C Y, see 102Ag C 9E+2 4E-7 1E-9 C C 47 Silver-112 D, see 102Ag 3E+3 8E+3 3E-6 1E-8 4E-5 4E-4 W, see 102Ag C 1E+4 4E-6 1E-8 C C Y, see 102Ag C 9E+3 4E-6 1E-8 C C 47 Silver-115b/ D, see 102Ag 3E+4 9E+4 4E-5 1E-7 C C W, see 102Ag C 9E+4 4E-5 1E-7 C C Y, see 102Ag C 8E+4 3E-5 1E-7 C C 48 Cadmium-104b/ D, all compounds except those given for W and Y 2E+4 7E+4 3E-5 9E-8 3E-4 3E-3 W, sulfides, halides, and nitrates C 1E+5 5E-5 2E-7 C C Y, oxides and hydroxides C 1E+5 5E-5 2E-7 C C 48 Cadmium-107 D, see 104Cd 2E+4 5E+4 2E-5 8E-8 3E-4 3E-3 W, see 104Cd C 6E+4 2E-5 8E-8 C C Y, see 104Cd C 5E+4 2E-5 7E-8 C C 48 Cadmium-109 D, see 104Cd 3E+2 4E+1 1E-8 C C C Kidneys Kidneys (4E+2) (5E+1) C 7E-11 6E-6 6E-5 W, see 104Cd C 1E+2 5E-8 C C C Kidneys C (1E+2) C 2E-10 C C Y, see 104Cd C 1E+2 5E-8 2E-10 C C 48 Cadmium-113m D, see 104Cd 2E+1 2E+0 1E-9 C C C Kidneys Kidneys (4E+1) (4E+0) C 5E-12 5E-7 5E-6 W, see 104Cd C 8E+0 4E-9 C C C Kidneys C (1E+1) C 2E-11 C C Y, see 104Cd C 1E+1 5E-9 2E-11 C C 48 Cadmium-113 D, see 104Cd 2E+1 2E+0 9E-10 C C C Kidneys Kidneys (3E+1) (3E+0) C 5E-12 4E-7 4E-6 W, see 104Cd C 8E+0 3E-9 C C C Kidneys C (1E+1) C 2E-11 C C Y, see 104Cd C 1E+1 6E-9 2E-11 C C 48 Cadmium-115m D, see 104Cd 3E+2 5E+1 2E-8 C 4E-6 4E-5 Kidneys C (8E+1) C 1E-10 C C W, see 104Cd C 1E+2 5E-8 2E-10 C C Y, see 104Cd C 1E+2 6E-8 2E-10 C C 48 Cadmium-115 D, see 104Cd 9E+2 1E+3 6E-7 2E-9 C C (1E+3) C C C 1E-5 1E-4 W, see 104Cd C 1E+3 5E-7 2E-9 C C Y, see 104Cd C 1E+3 6E-7 2E-9 C C Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml) 48 Cadmium-117m D, see 104Cd 5E+3 1E+4 5E-6 2E-8 6E-5 6E-4 W, see 104Cd C 2E+4 7E-6 2E-8 C C Y, see 104Cd C 1E+4 6E-6 2E-8 C C 48 Cadmium-117 D, see 104Cd 5E+3 1E+4 5E-6 2E-8 6E-5 6E-4 W, see 104Cd C 2E+4 7E-6 2E-8 C C Y, see 104Cd C 1E+4 6E-6 2E-8 C C 49 Indium-109 D, all compounds except those given for W 2E+4 4E+4 2E-5 6E-8 3E-4 3E-3 halides, and nitrates C 6E+4 3E-5 9E-8 C C 49 Indium-110b D, see 109In 2E+4 4E+4 2E-5 6E-8 2E-4 2E-3 (69.1 min) W, see 109In C 6E+4 2E-5 8E-8 C C 49 Indium-110 D, see 109In 5E+3 2E+4 7E-6 2E-8 7E-5 7E-4 (4.9 h) W, see 109In C 2E+4 8E-6 3E-8 C C 49 Indium-111 D, see 109In 4E+3 6E+3 3E-6 9E-9 6E-5 6E-4 W, see 109In C 6E+3 3E-6 9E-9 C C 49 Indium-112b D, see 109In 2E+5 6E+5 3E-4 9E-7 2E-3 2E-2 W, see 109In C 7E+5 3E-4 1E-6 C C 49 Indium-113mb D, see 109In 5E+4 1E+5 6E-5 2E-7 7E-4 7E-3 W, see 109In C 2E+5 8E-5 3E-7 C C 49 Indium-114m D, see 109In 3E+2 6E+1 3E-8 9E-11 C C (4E+2) C C C 5E-6 5E-5 W, see 109In C 1E+2 4E-8 1E-10 C C 49 Indium-115m D, see 109In 1E+4 4E+4 2E-5 6E-8 2E-4 2E-3 W, see 109In C 5E+4 2E-5 7E-8 C C 49 Indium-115 D, see 109In 4E+1 1E+0 6E-10 2E-12 5E-7 5E-6 W, see 109In C 5E+0 2E-9 8E-12 C C 49 Indium-116mb D, see 109In 2E+4 8E+4 3E-5 1E-7 3E-4 3E-3 W, see 109In C 1E+5 5E-5 2E-7 C C 49 Indium-117mb D, see 109In 1E+4 3E+4 1E-5 5E-8 2E-4 2E-3 W, see 109In C 4E+4 2E-5 6E-8 C C 49 Indium-117b D, see 109In 6E+4 2E+5 7E-5 2E-7 8E-4 8E-3 W, see 109In C 2E+5 9E-5 3E-7 C C 49 Indium-119mb D, see 109In 4E+4 1E+5 5E-5 2E-7 C C W, see 109In C 1E+5 6E-5 2E-7 C C 50 Tin-110 D, all compounds except those given for W 4E+3 1E+4 5E-6 2E-8 5E-5 5E-4 W, sulfides, oxides, hydroxides, halides, nitrates, and stannic phosphate C 1E+4 5E-6 2E-8 C C 50 Tin-111b D, see 110Sn 7E+4 2E+5 9E-5 3E-7 1E-3 1E-2 W, see 110Sn C 3E+5 1E-4 4E-7 C C Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml) 50 Tin-113 D, see 110Sn 2E+3 1E+3 5E-7 2E-9 C C W, see 110Sn C 5E+2 2E-7 8E-10 C C 50 Tin-117m D, see 110Sn 2E+3 1E+3 5E-7 C C C (2E+3) (2E+3) C 3E-9 3E-5 3E-4 W, see 110Sn C 1E+3 6E-7 2E-9 C C 50 Tin-119m D, see 110Sn 3E+3 2E+3 1E-6 3E-9 C C (4E+3) C C C 6E-5 6E-4 W, see 110Sn C 1E+3 4E-7 1E-9 C C 50 Tin-121m D, see 110Sn 3E+3 9E+2 4E-7 1E-9 C C (4E+3) C C C 5E-5 5E-4 W, see 110Sn C 5E+2 2E-7 8E-10 C C 50 Tin-121 D, see 110Sn 6E+3 2E+4 6E-6 2E-8 C C (6E+3) C C C 8E-5 8E-4 W, see 110Sn C 1E+4 5E-6 2E-8 C C 50 Tin-123mb D, see 110Sn 5E+4 1E+5 5E-5 2E-7 7E-4 7E-3 W, see 110Sn C 1E+5 6E-5 2E-7 C C 50 Tin-123 D, see 110Sn 5E+2 6E+2 3E-7 9E-10 C C (6E+2) C C C 9E-6 9E-5 W, see 110Sn C 2E+2 7E-8 2E-10 C C 50 Tin-125 D, see 110Sn 4E+2 9E+2 4E-7 1E-9 C C (5E+2) C C C 6E-6 6E-5 W, see 110Sn C 4E+2 1E-7 5E-10 C C 50 Tin-126 D, see 110Sn 3E+2 6E+1 2E-8 8E-11 4E-6 4E-5 W, see 110Sn C 7E+1 3E-8 9E-11 C C 50 Tin-127 D, see 110Sn 7E+3 2E+4 8E-6 3E-8 9E-5 9E-4 W, see 110Sn C 2E+4 8E-6 3E-8 C C 50 Tin-128b D, see 110Sn 9E+3 3E+4 1E-5 4E-8 1E-4 1E-3 W, see 110Sn C 4E+4 1E-5 5E-8 C C 51 Antimony-115b D, all compounds except those given for W 8E+4 2E+5 1E-4 3E-7 1E-3 1E-2 halides, sulfides, sulfates, and nitrates C 3E+5 1E-4 4E-7 C C 51 Antimony-116mb D, see 115Sb 2E+4 7E+4 3E-5 1E-7 3E-4 3E-3 W, see 115Sb C 1E+5 6E-5 2E-7 C C 51 Antimony-116b D, see 115Sb 7E+4 3E+5 1E-4 4E-7 C C W, see 115Sb C 3E+5 1E-4 5E-7 C C 51 Antimony-117 D, see 115Sb 7E+4 2E+5 9E-5 3E-7 9E-4 9E-3 W, see 115Sb C 3E+5 1E-4 4E-7 C C Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml) 51 Antimony-118m D, see 115Sb 6E+3 2E+4 8E-6 3E-8 7E-5 7E-4 W, see 115Sb 5E+3 2E+4 9E-6 3E-8 C C 51 Antimony-119 D, see 115Sb 2E+4 5E+4 2E-5 6E-8 2E-4 2E-3 W, see 115Sb 2E+4 3E+4 1E-5 4E-8 C C 51 Antimony-120b/ D, see 115Sb 1E+5 4E+5 2E-4 6E-7 C C (16 min) St wall (2E+5) C C C 2E-3 2E-2 W, see 115Sb C 5E+5 2E-4 7E-7 C C 51 Antimony-120 D, see 115Sb 1E+3 2E+3 9E-7 3E-9 1E-5 1E-4 (5.76 d) W, see 115Sb 9E+2 1E+3 5E-7 2E-9 C C 51 Antimony-122 D, see 115Sb 8E+2 2E+3 1E-6 3E-9 C C (8E+2) C C C 1E-5 1E-4 W, see 115Sb 7E+2 1E+3 4E-7 2E-9 C C 51 Antimony-124mb D, see 115Sb 3E+5 8E+5 4E-4 1E-6 3E-3 3E-2 W, see 115Sb 2E+5 6E+5 2E-4 8E-7 C C 51 Antimony-124 D, see 115Sb 6E+2 9E+2 4E-7 1E-9 7E-6 7E-5 W, see 115Sb 5E+2 2E+2 1E-7 3E-10 C C 51 Antimony-125 D, see 115Sb 2E+3 2E+3 1E-6 3E-9 3E-5 3E-4 W, see 115Sb C 5E+2 2E-7 7E-10 C C 51 Antimony-126mb D, see 115Sb 5E+4 2E+5 8E-5 3E-7 C C (7E+4) C C C 9E-4 9E-3 W, see 115Sb C 2E+5 8E-5 3E-7 C C 51 Antimony-126 D, see 115Sb 6E+2 1E+3 5E-7 2E-9 7E-6 7E-5 W, see 115Sb 5E+2 5E+2 2E-7 7E-10 C C 51 Antimony-127 D, see 115Sb 8E+2 2E+3 9E-7 3E-9 C C (8E+2) C C C 1E-5 1E-4 W, see 115Sb 7E+2 9E+2 4E-7 1E-9 C C 51 Antimony-128b D, see 115Sb 8E+4 4E+5 2E-4 5E-7 C C (10.4 min) St wall (1E+5) C C C 1E-3 1E-2 W, see 115Sb C 4E+5 2E-4 6E-7 C C 51 Antimony-128 D, see 115Sb 1E+3 4E+3 2E-6 6E-9 2E-5 2E-4 (9.01 h) W, see 115Sb C 3E+3 1E-6 5E-9 C C 51 Antimony-129 D, see 115Sb 3E+3 9E+3 4E-6 1E-8 4E-5 4E-4 W, see 115Sb C 9E+3 4E-6 1E-8 C C 51 Antimony-130b D, see 115Sb 2E+4 6E+4 3E-5 9E-8 3E-4 3E-3 W, see 115Sb C 8E+4 3E-5 1E-7 C C 51 Antimony-131b D, see 115Sb 1E+4 2E+4 1E-5 C C C (2E+4) (4E+4) C 6E-8 2E-4 2E-3 W, see 115Sb C 2E+4 1E-5 C C C (4E+4) C 6E-8 C C Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml) 52 Tellurium-116 D, all compounds except those given for W 8E+3 2E+4 9E-6 3E-8 1E-4 1E-3 and nitrates C 3E+4 1E-5 4E-8 C C 52 Tellurium-121m D, see 116Te 5E+2 2E+2 8E-8 C C C (7E+2) (4E+2) C 5E-10 1E-5 1E-4 W, see 116Te C 4E+2 2E-7 6E-10 C C 52 Tellurium-121 D, see 116Te 3E+3 4E+3 2E-6 6E-9 4E-5 4E-4 W, see 116Te C 3E+3 1E-6 4E-9 C C 52 Tellurium-123m D, see 116Te 6E+2 2E+2 9E-8 C C C (1E+3) (5E+2) C 8E-10 1E-5 1E-4 W, see 116Te C 5E+2 2E-7 8E-10 C C 52 Tellurium-123 D, see 116Te 5E+2 2E+2 8E-8 C C C (1E+3) (5E+2) C 7E-10 2E-5 2E-4 W, see 116Te C 4E+2 2E-7 C C C C (1E+3) C 2E-9 C C 52 Tellurium-125m D, see 116Te 1E+3 4E+2 2E-7 C C C (1E+3) (1E+3) C 1E-9 2E-5 2E-4 W, see 116Te C 7E+2 3E-7 1E-9 C C 52 Tellurium-127m D, see 116Te 6E+2 3E+2 1E-7 C 9E-6 9E-5 C (4E+2) C 6E-10 C C W, see 116Te C 3E+2 1E-7 4E-10 C C 52 Tellurium-127 D, see 116Te 7E+3 2E+4 9E-6 3E-8 1E-4 1E-3 W, see 116Te C 2E+4 7E-6 2E-8 C C 52 Tellurium-129m D, see 116Te 5E+2 6E+2 3E-7 9E-10 7E-6 7E-5 W, see 116Te C 2E+2 1E-7 3E-10 C C 52 Tellurium-129b D, see 116Te 3E+4 6E+4 3E-5 9E-8 4E-4 4E-3 W, see 116Te C 7E+4 3E-5 1E-7 C C 52 Tellurium-131m D, see 116Te 3E+2 4E+2 2E-7 C C C (6E+2) (1E+3) C 2E-9 8E-6 8E-5 W, see 116Te C 4E+2 2E-7 C C C C (9E+2) C 1E-9 C C 52 Tellurium-131b/ D, see 116Te 3E+3 5E+3 2E-6 C C C (6E+3) (1E+4) C 2E-8 8E-5 8E-4 W, see 116Te C 5E+3 2E-6 C C C C (1E+4) C 2E-8 C C 52 Tellurium-132 D, see 116Te 2E+2 2E+2 9E-8 C C C (7E+2) (8E+2) C 1E-9 9E-6 9E-5 W, see 116Te C 2E+2 9E-8 C C C C (6E+2) C 9E-10 C C Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml) 52 Tellurium-133mb D, see 116Te 3E+3 5E+3 2E-6 C C C (6E+3) (1E+4) C 2E-8 9E-5 9E-4 W, see 116Te C 5E+3 2E-6 C C C C (1E+4) C 2E-8 C C 52 Tellurium-133b D, see 116Te 1E+4 2E+4 9E-6 C C C (3E+4) (6E+4) C 8E-8 4E-4 4E-3 W, see 116Te C 2E+4 9E-6 C C C C (6E+4) C 8E-8 C C 52 Tellurium-134b D, see 116Te 2E+4 2E+4 1E-5 C C C (2E+4) (5E+4) C 7E-8 3E-4 3E-3 W, see 116Te C 2E+4 1E-5 C C C C (5E+4) C 7E-8 C C 53 Iodine-120mb D, all compounds 1E+4 2E+4 9E-6 3E-8 C C (1E+4) C C C 2E-4 2E-3 53 Iodine-120b D, all compounds 4E+3 9E+3 4E-6 C C C (8E+3) (1E+4) C 2E-8 1E-4 1E-3 53 Iodine-121 D, all compounds 1E+4 2E+4 8E-6 C C C (3E+4) (5E+4) C 7E-8 4E-4 4E-3 53 Iodine-123 D, all compounds 3E+3 6E+3 3E-6 C C C (1E+4) (2E+4) C 2E-8 1E-4 1E-3 53 Iodine-124 D, all compounds 5E+1 8E+1 3E-8 C C C (2E+2) (3E+2) C 4E-10 2E-6 2E-5 53 Iodine-125 D, all compounds 4E+1 6E+1 3E-8 C C C (1E+2) (2E+2) C 3E-10 2E-6 2E-5 53 Iodine-126 D, all compounds 2E+1 4E+1 1E-8 C C C (7E+1) (1E+2) C 2E-10 1E-6 1E-5 53 Iodine-128b D, all compounds 4E+4 1E+5 5E-5 2E-7 C C 53 Iodine-129 D, all compounds 5E+0 9E+0 4E-9 C C C (2E+1) (3E+1) C 4E-11 2E-7 2E-6 53 Iodine-130 D, all compounds 4E+2 7E+2 3E-7 C C C (1E+3) (2E+3) C 3E-9 2E-5 2E-4 Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml) 53 Iodine-131 D, all compounds 3E+1 5E+1 2E-8 C C C (9E+1) (2E+2) C 2E-10 1E-6 1E-5 53 Iodine-132mb D, all compounds 4E+3 8E+3 4E-6 C C C (1E+4) (2E+4) C 3E-8 1E-4 1E-3 53 Iodine-132 D, all compounds 4E+3 8E+3 3E-6 C C C (9E+3) (1E+4) C 2E-8 1E-4 1E-3 53 Iodine-133 D, all compounds 1E+2 3E+2 1E-7 C C C (5E+2) (9E+2) C 1E-9 7E-6 7E-5 53 Iodine-134b D, all compounds 2E+4 5E+4 2E-5 6E-8 C C 53 Iodine-135 D, all compounds 8E+2 2E+3 7E-7 C C C (3E+3) (4E+3) C 6E-9 3E-5 3E-4 54 Xenon-120b Submersiona/ C C 1E-5 4E-8 C C 54 Xenon-121b Submersiona/ C C 2E-6 1E-8 C C 54 Xenon-122 Submersiona/ C C 7E-5 3E-7 C C 54 Xenon-123 Submersiona/ C C 6E-6 3E-8 C C 54 Xenon-125 Submersiona/ C C 2E-5 7E-8 C C 54 Xenon-127 Submersiona/ C C 1E-5 6E-8 C C 54 Xenon-129m Submersiona/ C C 2E-4 9E-7 C C 54 Xenon-131m Submersiona/ C C 4E-4 2E-6 C C 54 Xenon-133m Submersiona/ C C 1E-4 6E-7 C C 54 Xenon-133 Submersiona/ C C 1E-4 5E-7 C C 54 Xenon-135mb Submersiona/ C C 9E-6 4E-8 C C 54 Xenon-135 Submersiona/ C C 1E-5 7E-8 C C 54 Xenon-138b Submersiona/ C C 4E-6 2E-8 C C 55 Cesium-125b D, all compounds 5E+4 1E+5 6E-5 2E-7 C C 55 Cesium-127 D, all compounds 6E+4 9E+4 4E-5 1E-7 9E-4 9E-3 55 Cesium-129 D, all compounds 2E+4 3E+4 1E-5 5E-8 3E-4 3E-3 55 Cesium-130b D, all compounds 6E+4 2E+5 8E-5 3E-7 C C (1E+5) C C C 1E-3 1E-2 55 Cesium-131 D, all compounds 2E+4 3E+4 1E-5 4E-8 3E-4 3E-3 Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml) 55 Cesium-132 D, all compounds 3E+3 4E+3 2E-6 6E-9 4E-5 4E-4 55 Cesium-134m D, all compounds 1E+5 1E+5 6E-5 2E-7 C C (1E+5) C C C 2E-3 2E-2 55 Cesium-134 D, all compounds 7E+1 1E+2 4E-8 2E-10 9E-7 9E-6 55 Cesium-135mb D, all compounds 1E+5 2E+5 8E-5 3E-7 1E-3 1E-2 55 Cesium-135 D, all compounds 7E+2 1E+3 5E-7 2E-9 1E-5 1E-4 55 Cesium-136 D, all compounds 4E+2 7E+2 3E-7 9E-10 6E-6 6E-5 55 Cesium-137 D, all compounds 1E+2 2E+2 6E-8 2E-10 1E-6 1E-5 55 Cesium-138b D, all compounds 2E+4 6E+4 2E-5 8E-8 C C 56 Barium-126b D, all compounds 6E+3 2E+4 6E-6 2E-8 8E-5 8E-4 56 Barium-128 D, all compounds 5E+2 2E+3 7E-7 2E-9 7E-6 7E-5 56 Barium-131mb D, all compounds 4E+5 1E+6 6E-4 2E-6 C C (5E+5) C C C 7E-3 7E-2 56 Barium-131 D, all compounds 3E+3 8E+3 3E-6 1E-8 4E-5 4E-4 56 Barium-133m D, all compounds 2E+3 9E+3 4E-6 1E-8 C C 56 Barium-133 D, all compounds 2E+3 7E+2 3E-7 9E-10 2E-5 2E-4 56 Barium-135m D, all compounds 3E+3 1E+4 5E-6 2E-8 4E-5 4E-4 56 Barium-139b D, all compounds 1E+4 3E+4 1E-5 4E-8 2E-4 2E-3 56 Barium-140 D, all compounds 5E+2 1E+3 6E-7 2E-9 C C 56 Barium-141b D, all compounds 2E+4 7E+4 3E-5 1E-7 3E-4 3E-3 56 Barium-142b D, all compounds 5E+4 1E+5 6E-5 2E-7 7E-4 7E-3 57 Lanthanum-131b D, all compounds except those given for W 5E+4 1E+5 5E-5 2E-7 6E-4 6E-3 W, oxides and hydroxides C 2E+5 7E-5 2E-7 C C 57 Lanthanum-132 D, see 131La 3E+3 1E+4 4E-6 1E-8 4E-5 4E-4 W, see 131La C 1E+4 5E-6 2E-8 C C 57 Lanthanum-135 D, see 131La 4E+4 1E+5 4E-5 1E-7 5E-4 5E-3 W, see 131La C 9E+4 4E-5 1E-7 C C 57 Lanthanum-137 D, see 131La 1E+4 6E+1 3E-8 C 2E-4 2E-3 Liver C (7E+1) C 1E-10 C C W, see 131La C 3E+2 1E-7 C C C Liver C (3E+2) C 4E-10 C C Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml) 57 Lanthanum-138 D, see 131La 9E+2 4E+0 1E-9 5E-12 1E-5 1E-4 W, see 131La C 1E+1 6E-9 2E-11 C C 57 Lanthanum-140 D, see 131La 6E+2 1E+3 6E-7 2E-9 9E-6 9E-5 W, see 131La C 1E+3 5E-7 2E-9 C C 57 Lanthanum-141 D, see 131La 4E+3 9E+3 4E-6 1E-8 5E-5 5E-4 W, see 131La C 1E+4 5E-6 2E-8 C C 57 Lanthanum-142b/ D, see 131La 8E+3 2E+4 9E-6 3E-8 1E-4 1E-3 W, see 131La C 3E+4 1E-5 5E-8 C C 57 Lanthanum-143b/ D, see 131La 4E+4 1E+5 4E-5 1E-7 C C W, see 131La C 9E+4 4E-5 1E-7 C C 58 Cerium-134 W, all compounds except those given for Y 5E+2 7E+2 3E-7 1E-9 C C and fluorides C 7E+2 3E-7 9E-10 C C 58 Cerium-135 W, see 134Ce 2E+3 4E+3 2E-6 5E-9 2E-5 2E-4 Y, see 134Ce C 4E+3 1E-6 5E-9 C C 58 Cerium-137m W, see 134Ce 2E+3 4E+3 2E-6 6E-9 C C Y, see 134Ce C 4E+3 2E-6 5E-9 C C 58 Cerium-137 W, see 134Ce 5E+4 1E+5 6E-5 2E-7 7E-4 7E-3 Y, see 134Ce C 1E+5 5E-5 2E-7 C C 58 Cerium-139 W, see 134Ce 5E+3 8E+2 3E-7 1E-9 7E-5 7E-4 Y, see 134Ce C 7E+2 3E-7 9E-10 C C 58 Cerium-141 W, see 134Ce 2E+3 7E+2 3E-7 1E-9 C C Y, see 134Ce C 6E+2 2E-7 8E-10 C C 58 Cerium-143 W, see 134Ce 1E+3 2E+3 8E-7 3E-9 C C Y, see 134Ce C 2E+3 7E-7 2E-9 C C 58 Cerium-144 W, see 134Ce 2E+2 3E+1 1E-8 4E-11 C C (3E+2) C C C 3E-6 3E-5 Y, see 134Ce C 1E+1 6E-9 2E-11 C C 59 Praseodymium-136b W, all compounds except those given for Y 5E+4 2E+5 1E-4 3E-7 C C carbides, and fluorides C 2E+5 9E-5 3E-7 C C 59 Praseodymium-137b W, see 136Pr 4E+4 2E+5 6E-5 2E-7 5E-4 5E-3 Y, see 136Pr C 1E+5 6E-5 2E-7 C C 59 Praseodymium-138m W, see 136Pr 1E+4 5E+4 2E-5 8E-8 1E-4 1E-3 Y, see 136Pr C 4E+4 2E-5 6E-8 C C Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml) 59 Praseodymium-139 W, see 136Pr 4E+4 1E+5 5E-5 2E-7 6E-4 6E-3 Y, see 136Pr C 1E+5 5E-5 2E-7 C C 59 Praseodymium-142mb W, see 136Pr 8E+4 2E+5 7E-5 2E-7 1E-3 1E-2 Y, see 136Pr C 1E+5 6E-5 2E-7 C C 59 Praseodymium-142 W, see 136Pr 1E+3 2E+3 9E-7 3E-9 1E-5 1E-4 Y, see 136Pr C 2E+3 8E-7 3E-9 C C 59 Praseodymium-143 W, see 136Pr 9E+2 8E+2 3E-7 1E-9 C C Y, see 136Pr C 7E+2 3E-7 9E-10 C C 59 Praseodymium-144b W, see 136Pr 3E+4 1E+5 5E-5 2E-7 C C Y, see 136Pr C 1E+5 5E-5 2E-7 C C 59 Praseodymium-145 W, see 136Pr 3E+3 9E+3 4E-6 1E-8 4E-5 4E-4 Y, see 136Pr C 8E+3 3E-6 1E-8 C C 59 Praseodymium-147b W, see 136Pr 5E+4 2E+5 8E-5 3E-7 C C (8E+4) C C C 1E-3 1E-2 Y, see 136Pr C 2E+5 8E-5 3E-7 C C 60 Neodymium-136b/ W, all compounds except those given for Y 1E+4 6E+4 2E-5 8E-8 2E-4 2E-3 carbides, and fluorides C 5E+4 2E-5 8E-8 C C 60 Neodymium-138 W, see 136Nd 2E+3 6E+3 3E-6 9E-9 3E-5 3E-4 Y, see 136Nd C 5E+3 2E-6 7E-9 C C 60 Neodymium-139m W, see 136Nd 5E+3 2E+4 7E-6 2E-8 7E-5 7E-4 Y, see 136Nd C 1E+4 6E-6 2E-8 C C 60 Neodymium-139b W, see 136Nd 9E+4 3E+5 1E-4 5E-7 1E-3 1E-2 Y, see 136Nd C 3E+5 1E-4 4E-7 C C 60 Neodymium-141 W, see 136Nd 2E+5 7E+5 3E-4 1E-6 2E-3 2E-2 Y, see 136Nd C 6E+5 3E-4 9E-7 C C 60 Neodymium-147 W, see 136Nd 1E+3 9E+2 4E-7 1E-9 C C Y, see 136Nd C 8E+2 4E-7 1E-9 C C 60 Neodymium-149b W, see 136Nd 1E+4 3E+4 1E-5 4E-8 1E-4 1E-3 Y, see 136Nd C 2E+4 1E-5 3E-8 C C 60 Neodymium-151b W, see 136Nd 7E+4 2E+5 8E-5 3E-7 9E-4 9E-3 Y, see 136Nd C 2E+5 8E-5 3E-7 C C 61 Promethium-141b W, all compounds except those given for Y 5E+4 2E+5 8E-5 3E-7 C C carbides, and fluorides C 2E+5 7E-5 2E-7 C C 61 Promethium-143 W, see 141Pm 5E+3 6E+2 2E-7 8E-10 7E-5 7E-4 Y, see 141Pm C 7E+2 3E-7 1E-9 C C Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml) 61 Promethium-144 W, see 141Pm 1E+3 1E+2 5E-8 2E-10 2E-5 2E-4 Y, see 141Pm C 1E+2 5E-8 2E-10 C C 61 Promethium-145 W, see 141Pm 1E+4 2E+2 7E-8 C 1E-4 1E-3 C (2E+2) C 3E-10 C C Y, see 141Pm C 2E+2 8E-8 3E-10 C C 61 Promethium-146 W, see 141Pm 2E+3 5E+1 2E-8 7E-11 2E-5 2E-4 Y, see 141Pm C 4E+1 2E-8 6E-11 C C 61 Promethium-147 W, see 141Pm 4E+3 1E+2 5E-8 C C C (5E+3) (2E+2) C 3E-10 7E-5 7E-4 Y, see 141Pm C 1E+2 6E-8 2E-10 C C 61 Promethium-148m W, see 141Pm 7E+2 3E+2 1E-7 4E-10 1E-5 1E-4 Y, see 141Pm C 3E+2 1E-7 5E-10 C C 61 Promethium-148 W, see 141Pm 4E+2 5E+2 2E-7 8E-10 C C (5E+2) C C C 7E-6 7E-5 Y, see 141Pm C 5E+2 2E-7 7E-10 C C 61 Promethium-149 W, see 141Pm 1E+3 2E+3 8E-7 3E-9 C C Y, see 141Pm C 2E+3 8E-7 2E-9 C C 61 Promethium-150 W, see 141Pm 5E+3 2E+4 8E-6 3E-8 7E-5 7E-4 Y, see 141Pm C 2E+4 7E-6 2E-8 C C 61 Promethium-151 W, see 141Pm 2E+3 4E+3 1E-6 5E-9 2E-5 2E-4 Y, see 141Pm C 3E+3 1E-6 4E-9 C C 62 Samarium-141mb W, all compounds 3E+4 1E+5 4E-5 1E-7 4E-4 4E-3 62 Samarium-141b W, all compounds 5E+4 2E+5 8E-5 2E-7 C C 62 Samarium-142b W, all compounds 8E+3 3E+4 1E-5 4E-8 1E-4 1E-3 62 Samarium-145 W, all compounds 6E+3 5E+2 2E-7 7E-10 8E-5 8E-4 62 Samarium-146 W, all compounds 1E+1 4E-2 1E-11 C C C (3E+1) (6E-2) C 9E-14 3E-7 3E-6 62 Samarium-147 W, all compounds 2E+1 4E-2 2E-11 C C C (3E+1) (7E-2) C 1E-13 4E-7 4E-6 62 Samarium-151 W, all compounds 1E+4 1E+2 4E-8 C C C (1E+4) (2E+2) C 2E-10 2E-4 2E-3 62 Samarium-153 W, all compounds 2E+3 3E+3 1E-6 4E-9 C C 62 Samarium-155b W, all compounds 6E+4 2E+5 9E-5 3E-7 C C (8E+4) C C C 1E-3 1E-2 Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml) 62 Samarium-156 W, all compounds 5E+3 9E+3 4E-6 1E-8 7E-5 7E-4 63 Europium-145 W, all compounds 2E+3 2E+3 8E-7 3E-9 2E-5 2E-4 63 Europium-146 W, all compounds 1E+3 1E+3 5E-7 2E-9 1E-5 1E-4 63 Europium-147 W, all compounds 3E+3 2E+3 7E-7 2E-9 4E-5 4E-4 63 Europium-148 W, all compounds 1E+3 4E+2 1E-7 5E-10 1E-5 1E-4 63 Europium-149 W, all compounds 1E+4 3E+3 1E-6 4E-9 2E-4 2E-3 63 Europium-150 W, all compounds 3E+3 8E+3 4E-6 1E-8 4E-5 4E-4 (12.62 h) 63 Europium-150 W, all compounds 8E+2 2E+1 8E-9 3E-11 1E-5 1E-4 (34.2 y) 63 Europium-152m W, all compounds 3E+3 6E+3 3E-6 9E-9 4E-5 4E-4 63 Europium-152 W, all compounds 8E+2 2E+1 1E-8 3E-11 1E-5 1E-4 63 Europium-154 W, all compounds 5E+2 2E+1 8E-9 3E-11 7E-6 7E-5 63 Europium-155 W, all compounds 4E+3 9E+1 4E-8 C 5E-5 5E-4 C (1E+2) C 2E-10 C C 63 Europium-156 W, all compounds 6E+2 5E+2 2E-7 6E-10 8E-6 8E-5 63 Europium-157 W, all compounds 2E+3 5E+3 2E-6 7E-9 3E-5 3E-4 63 Europium-158b/ W, all compounds 2E+4 6E+4 2E-5 8E-8 3E-4 3E-3 64 Gadolinium-145b/ D, all compounds except those given for W 5E+4 2E+5 6E-5 2E-7 C C (5E+4) C C C 6E-4 6E-3 and fluorides C 2E+5 7E-5 2E-7 C C 64 Gadolinium-146 D, see 145Gd 1E+3 1E+2 5E-8 2E-10 2E-5 2E-4 W, see 145Gd C 3E+2 1E-7 4E-10 C C 64 Gadolinium-147 D, see 145Gd 2E+3 4E+3 2E-6 6E-9 3E-5 3E-4 W, see 145Gd C 4E+3 1E-6 5E-9 C C 64 Gadolinium-148 D, see 145Gd 1E+1 8E+3 3E-12 C C C (2E+1) (2E-2) C 2E-14 3E-7 3E-6 W, see 145Gd C 3E-2 1E-11 C C C C (6E-2) C 8E-14 C C 64 Gadolinium-149 D, see 145Gd 3E+3 2E+3 9E-7 3E-9 4E-5 4E-4 W, see 145Gd C 2E+3 1E-6 3E-9 C C 64 Gadolinium-151 D, see 145Gd 6E+3 4E+2 2E-7 C 9E-5 9E-4 C (6E+2) C 9E-10 C C W, see 145Gd C 1E+3 5E-7 2E-9 C C Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml) 64 Gadolinium-152 D, see 145Gd 2E+1 1E-2 4E-12 C C C (3E+1) (2E-2) C 3E-14 4E-7 4E-6 W, see 145Gd C 4E-2 2E-11 C C C C (8E-2) C 1E-13 C C 64 Gadolinium-153 D, see 145Gd 5E+3 1E+2 6E-8 C 6E-5 6E-4 C (2E+2) C 3E-10 C C W, see 145Gd C 6E+2 2E-7 8E-10 C C 64 Gadolinium-159 D, see 145Gd 3E+3 8E+3 3E-6 1E-8 4E-5 4E-4 W, see 145Gd C 6E+3 2E-6 8E-9 C C 65 Terbium-147b W, all compounds 9E+3 3E+4 1E-5 5E-8 1E-4 1E-3 65 Terbium-149 W, all compounds 5E+3 7E+2 3E-7 1E-9 7E-5 7E-4 65 Terbium-150 W, all compounds 5E+3 2E+4 9E-6 3E-8 7E-5 7E-4 65 Terbium-151 W, all compounds 4E+3 9E+3 4E-6 1E-8 5E-5 5E-4 65 Terbium-153 W, all compounds 5E+3 7E+3 3E-6 1E-8 7E-5 7E-4 65 Terbium-154 W, all compounds 2E+3 4E+3 2E-6 6E-9 2E-5 2E-4 65 Terbium-155 W, all compounds 6E+3 8E+3 3E-6 1E-8 8E-5 8E-4 65 Terbium-156m W, all compounds 2E+4 3E+4 1E-5 4E-8 2E-4 2E-3 (5.0 h) 65 Terbium-156m W, all compounds 7E+3 8E+3 3E-6 1E-8 1E-4 1E-3 (24.4 h) 65 Terbium-156 W, all compounds 1E+3 1E+3 6E-7 2E-9 1E-5 1E-4 65 Terbium-157 W, all compounds 5E+4 3E+2 1E-7 C C C (5E+4) (6E+2) C 8E-10 7E-4 7E-3 65 Terbium-158 W, all compounds 1E+3 2E+1 8E-9 3E-11 2E-5 2E-4 65 Terbium-160 W, all compounds 8E+2 2E+2 9E-8 3E-10 1E-5 1E-4 65 Terbium-161 W, all compounds 2E+3 2E+3 7E-7 2E-9 C C 66 Dysprosium-155 W, all compounds 9E+3 3E+4 1E-5 4E-8 1E-4 1E-3 66 Dysprosium-157 W, all compounds 2E+4 6E+4 3E-5 9E-8 3E-4 3E-3 66 Dysprosium-159 W, all compounds 1E+4 2E+3 1E-6 3E-9 2E-4 2E-3 66 Dysprosium-165 W, all compounds 1E+4 5E+4 2E-5 6E-8 2E-4 2E-3 66 Dysprosium-166 W, all compounds 6E+2 7E+2 3E-7 1E-9 C C (8E+2) C C C 1E-5 1E-4 67 Holmium-155b W, all compounds 4E+4 2E+5 6E-5 2E-7 6E-4 6E-3 Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml) 67 Holmium-157b W, all compounds 3E+5 1E+6 6E-4 2E-6 4E-3 4E-2 67 Holmium-159b W, all compounds 2E+5 1E+6 4E-4 1E-6 3E-3 3E-2 67 Holmium-161 W, all compounds 1E+5 4E+5 2E-4 6E-7 1E-3 1E-2 67 Holmium-162mb W, all compounds 5E+4 3E+5 1E-4 4E-7 7E-4 7E-3 67 Holmium-162b W, all compounds 5E+5 2E+6 1E-3 3E-6 C C (8E+5) C C C 1E-2 1E-1 67 Holmium-164mb/ W, all compounds 1E+5 3E+5 1E-4 4E-7 1E-3 1E-2 67 Holmium-164b/ W, all compounds 2E+5 6E+5 3E-4 9E-7 C C (2E+5) C C C 3E-3 3E-2 67 Holmium-166m W, all compounds 6E+2 7E+0 3E-9 9E-12 9E-6 9E-5 67 Holmium-166 W, all compounds 9E+2 2E+3 7E-7 2E-9 C C (9E+2) C C C 1E-5 1E-4 67 Holmium-167 W, all compounds 2E+4 6E+4 2E-5 8E-8 2E-4 2E-3 68 Erbium-161 W, all compounds 2E+4 6E+4 3E-5 9E-8 2E-4 2E-3 68 Erbium-165 W, all compounds 6E+4 2E+5 8E-5 3E-7 9E-4 9E-3 68 Erbium-169 W, all compounds 3E+3 3E+3 1E-6 4E-9 C C (4E+3) - C C 5E-5 5E-4 68 Erbium-171 W, all compounds 4E+3 1E+4 4E-6 1E-8 5E-5 5E-4 68 Erbium-172 W, all compounds 1E+3 1E+3 6E-7 2E-9 C C (1E+3) - C C 2E-5 2E-4 69 Thulium-162b W, all compounds 7E+4 3E+5 1E-4 4E-7 C C (7E+4) - C C 1E-3 1E-2 69 Thulium-166 W, all compounds 4E+3 1E+4 6E-6 2E-8 6E-5 6E-4 69 Thulium-167 W, all compounds 2E+3 2E+3 8E-7 3E-9 C C (2E+3) - C C 3E-5 3E-4 69 Thulium-170 W, all compounds 8E+2 2E+2 9E-8 3E-10 C C (1E+3) - C C 1E-5 1E-4 69 Thulium-171 W, all compounds 1E+4 3E+2 1E-7 C C C (1E+4) (6E+2) C 8E-10 2E-4 2E-3 69 Thulium-172 W, all compounds 7E+2 1E+3 5E-7 2E-9 C C (8E+2) - C C 1E-5 1E-4 69 Thulium-173 W, all compounds 4E+3 1E+4 5E-6 2E-8 6E-5 6E-4 Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml) 69 Thulium-175b W, all compounds 7E+4 3E+5 1E-4 4E-7 C C (9E+4) - C C 1E-3 1E-2 70 Ytterbium-162b W, all compounds except those given for Y 7E+4 3E+5 1E-4 4E-7 1E-3 1E-2 and fluorides C 3E+5 1E-4 4E-7 C C 70 Ytterbium-166 W, see 162Yb 1E+3 2E+3 8E-7 3E-9 2E-5 2E-4 Y, see 162Yb C 2E+3 8E-7 3E-9 C C 70 Ytterbium-167b W, see 162Yb 3E+5 8E+5 3E-4 1E-6 4E-3 4E-2 Y, see 162Yb C 7E+5 3E-4 1E-6 C C 70 Ytterbium-169 W, see 162Yb 2E+3 8E+2 4E-7 1E-9 2E-5 2E-4 Y, see 162Yb C 7E+2 3E-7 1E-9 C C 70 Ytterbium-175 W, see 162Yb 3E+3 4E+3 1E-6 5E-9 C C Y, see 162Yb C 3E+3 1E-6 5E-9 C C 70 Ytterbium-177b W, see 162Yb 2E+4 5E+4 2E-5 7E-8 2E-4 2E-3 Y, see 162Yb C 5E+4 2E-5 6E-8 C C 70 Ytterbium-178b W, see 162Yb 1E+4 4E+4 2E-5 6E-8 2E-4 2E-3 Y, see 162Yb C 4E+4 2E-5 5E-8 C C 71 Lutetium-169 W, all compounds except those given for Y 3E+3 4E+3 2E-6 6E-9 3E-5 3E-4 and fluorides C 4E+3 2E-6 6E-9 C C 71 Lutetium-170 W, see 169Lu 1E+3 2E+3 9E-7 3E-9 2E-5 2E-4 Y, see 169Lu C 2E+3 8E-7 3E-9 C C 71 Lutetium-171 W, see 169Lu 2E+3 2E+3 8E-7 3E-9 3E-5 3E-4 Y, see 169Lu C 2E+3 8E-7 3E-9 C C 71 Lutetium-172 W, see 169Lu 1E+3 1E+3 5E-7 2E-9 1E-5 1E-4 Y, see 169Lu C 1E+3 5E-7 2E-9 C C 71 Lutetium-173 W, see 169Lu 5E+3 3E+2 1E-7 C 7E-5 7E-4 C (5E+2) C 6E-10 C C Y, see 169Lu C 3E+2 1E-7 4E-10 C C 71 Lutetium-174m W, see 169Lu 2E+3 2E+2 1E-7 C C C (3E+3) (3E+2) C 5E-10 4E-5 4E-4 Y, see 169Lu C 2E+2 9E-8 3E-10 C C 71 Lutetium-174 W, see 169Lu 5E+3 1E+2 5E-8 C 7E-5 7E-4 C (2E+2) C 3E-10 C C Y, see 169Lu C 2E+2 6E-8 2E-10 C C 71 Lutetium-176m W, see 169Lu 8E+3 3E+4 1E-5 3E-8 1E-4 1E-3 Y, see 169Lu C 2E+4 9E-6 3E-8 C C Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml) 71 Lutetium-176 W, see 169Lu 7E+2 5E+0 2E-9 C 1E-5 1E-4 C (1E+1) C 2E-11 C C Y, see 169Lu C 8E+0 3E-9 1E-11 C C 71 Lutetium-177m W, see 169Lu 7E+2 1E+2 5E-8 C 1E-5 1E-4 C (1E+2) C 2E-10 C C Y, see 169Lu C 8E+1 3E-8 1E-10 C C 71 Lutetium-177 W, see 169Lu 2E+3 2E+3 9E-7 3E-9 C C Y, see 169Lu C 2E+3 9E-7 3E-9 C C 71 Lutetium-178mb W, see 169Lu 5E+4 2E+5 8E-5 3E-7 C C Y, see 169Lu C 2E+5 7E-5 2E-7 C C 71 Lutetium-178b W, see 169Lu 4E+4 1E+5 5E-5 2E-7 C C Y, see 169Lu C 1E+5 5E-5 2E-7 C C 71 Lutetium-179 W, see 169Lu 6E+3 2E+4 8E-6 3E-8 9E-5 9E-4 Y, see 169Lu C 2E+4 6E-6 3E-8 C C 72 Hafnium-170 D, all compounds except those given for W 3E+3 6E+3 2E-6 8E-9 4E-5 4E-4 carbides, and nitrates C 5E+3 2E-6 6E-9 C C 72 Hafnium-172 D, see 170Hf 1E+3 9E+0 4E-9 C 2E-5 2E-4 C (2E+1) C 3E-11 C C W, see 170Hf C 4E+1 2E-8 C C C C (6E+1) C 8E-11 C C 72 Hafnium-173 D, see 170Hf 5E+3 1E+4 5E-6 2E-8 7E-5 7E-4 W, see 170Hf C 1E+4 5E-6 2E-8 C C 72 Hafnium-175 D, see 170Hf 3E+3 9E+2 4E-7 C 4E-5 4E-4 C (1E+3) C 1E-9 C C W, see 170Hf C 1E+3 5E-7 2E-9 C C 72 Hafnium-177mb D, see 170Hf 2E+4 6E+4 2E-5 8E-8 3E-4 3E-3 W, see 170Hf C 9E+4 4E-5 1E-7 C C 72 Hafnium-178m D, see 170Hf 3E+2 1E+0 5E-10 C 3E-6 3E-5 C (2E+0) C 3E-12 C C W, see 170Hf C 5E+0 2E-9 C C C C (9E+0) C 1E-11 C C 72 Hafnium-179m D, see 170Hf 1E+3 3E+2 1E-7 C 1E-5 1E-4 C (6E+2) C 8E-10 C C W, see 170Hf C 6E+2 3E-7 8E-10 C C 72 Hafnium-180m D, see 170Hf 7E+3 2E+4 9E-6 3E-8 1E-4 1E-3 W, see 170Hf C 3E+4 1E-5 4E-8 C C Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml) 72 Hafnium-181 D, see 170Hf 1E+3 2E+2 7E-8 C 2E-5 2E-4 C (4E+2) C 6E-10 C C W, see 170Hf C 4E+2 2E-7 6E-10 C C 72 Hafnium-182mb D, see 170Hf 4E+4 9E+4 4E-5 1E-7 5E-4 5E-3 W, see 170Hf C 1E+5 6E-5 2E-7 C C 72 Hafnium-182 D, see 170Hf 2E+2 8E-1 3E-10 C C C (4E+2) (2E+0) C 2E-12 5E-6 5E-5 W, see 170Hf C 3E+0 1E-9 C C C C (7E+0) C 1E-11 C C 72 Hafnium-183b D, see 170Hf 2E+4 5E+4 2E-5 6E-8 3E-4 3E-3 W, see 170Hf C 6E+4 2E-5 8E-8 C C 72 Hafnium-184 D, see 170Hf 2E+3 8E+3 3E-6 1E-8 3E-5 3E-4 W, see 170Hf C 6E+3 3E-6 9E-9 C C 73 Tantalum-172b W, all compounds except those given for Y 4E+4 1E+5 5E-5 2E-7 5E-4 5E-3 Y, elemental Ta, oxides, hydroxides, halides, carbides, nitrates, and nitrides C 1E+5 4E-5 1E-7 C C 73 Tantalum-173 W, see 172Ta 7E+3 2E+4 8E-6 3E-8 9E-5 9E-4 Y, see 172Ta C 2E+4 7E-6 2E-8 C C 73 Tantalum-174b W, see 172Ta 3E+4 1E+5 4E-5 1E-7 4E-4 4E-3 Y, see 172Ta C 9E+4 4E-5 1E-7 C C 73 Tantalum-175 W, see 172Ta 6E+3 2E+4 7E-6 2E-8 8E-5 8E-4 Y, see 172Ta C 1E+4 6E-6 2E-8 C C 73 Tantalum-176 W, see 172Ta 4E+3 1E+4 5E-6 2E-8 5E-5 5E-4 Y, see 172Ta C 1E+4 5E-6 2E-8 C C 73 Tantalum-177 W, see 172Ta 1E+4 2E+4 8E-6 3E-8 2E-4 2E-3 Y, see 172Ta C 2E+4 7E-6 2E-8 C C 73 Tantalum-178 W, see 172Ta 2E+4 9E+4 4E-5 1E-7 2E-4 2E-3 Y, see 172Ta C 7E+4 3E-5 1E-7 C C 73 Tantalum-179 W, see 172Ta 2E+4 5E+3 2E-6 8E-9 3E-4 3E-3 Y, see 172Ta C 9E+2 4E-7 1E-9 C C 73 Tantalum-180m W, see 172Ta 2E+4 7E+4 3E-5 9E-8 3E-4 3E-3 Y, see 172Ta C 6E+4 2E-5 8E-8 C C 73 Tantalum-180 W, see 172Ta 1E+3 4E+2 2E-7 6E-10 2E-5 2E-4 Y, see 172Ta C 2E+1 1E-8 3E-11 C C 73 Tantalum-182mb W, see 172Ta 2E+5 5E+5 2E-4 8E-7 C C (2E+5) C C C 3E-3 3E-2 Y, see 172Ta C 4E+5 2E-4 6E-7 C C 73 Tantalum-182 W, see 172Ta 8E+2 3E+2 1E-7 5E-10 1E-5 1E-4 Y, see 172Ta C 1E+2 6E-8 2E-10 C C Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml) 73 Tantalum-183 W, see 172Ta 9E+2 1E+3 5E-7 2E-9 C C Y, see 172Ta C 1E+3 4E-7 1E-9 C C 73 Tantalum-184 W, see 172Ta 2E+3 5E+3 2E-6 8E-9 3E-5 3E-4 Y, see 172Ta C 5E+3 2E-6 7E-9 C C 73 Tantalum-185b W, see 172Ta 3E+4 7E+4 3E-5 1E-7 4E-4 4E-3 Y, see 172Ta C 6E+4 3E-5 9E-8 C C 73 Tantalum-186b W, see 172Ta 5E+4 2E+5 1E-4 3E-7 C C Y, see 172Ta C 2E+5 9E-5 3E-7 C C 74 Tungsten-176 D, all compounds 1E+4 5E+4 2E-5 7E-8 1E-4 1E-3 74 Tungsten-177 D, all compounds 2E+4 9E+4 4E-5 1E-7 3E-4 3E-3 74 Tungsten-178 D, all compounds 5E+3 2E+4 8E-6 3E-8 7E-5 7E-4 74 Tungsten-179b/ D, all compounds 5E+5 2E+6 7E-4 2E-6 7E-3 7E-2 74 Tungsten-181 D, all compounds 2E+4 3E+4 1E-5 5E-8 2E-4 2E-3 74 Tungsten-185 D, all compounds 2E+3 7E+3 3E-6 9E-9 C C 74 Tungsten-187 D, all compounds 2E+3 9E+3 4E-6 1E-8 3E-5 3E-4 74 Tungsten-188 D, all compounds 4E+2 1E+3 5E-7 2E-9 C C (5E+2) C C C 7E-6 7E-5 75 Rhenium-177b D, all compounds except those given for W 9E+4 3E+5 1E-4 4E-7 C C (1E+5) C C C 2E-3 2E-2 and nitrates C 4E+5 1E-4 5E-7 C C 75 Rhenium-178b D, see 177Re 7E+4 3E+5 1E-4 4E-7 C C (1E+5) C C C 1E-3 1E-2 W, see 177Re C 3E+5 1E-4 4E-7 C C 75 Rhenium-181 D, see 177Re 5E+3 9E+3 4E-6 1E-8 7E-5 7E-4 W, see 177Re C 9E+3 4E-6 1E-8 C C 75 Rhenium-182 D, see 177Re 7E+3 1E+4 5E-6 2E-8 9E-5 9E-4 (12.7 h) W, see 177Re C 2E+4 6E-6 2E-8 C C 75 Rhenium-182 D, see 177Re 1E+3 2E+3 1E-6 3E-9 2E-5 2E-4 (64.0 h) W, see 177Re C 2E+3 9E-7 3E-9 C C 75 Rhenium-184m D, see 177Re 2E+3 3E+3 1E-6 4E-9 3E-5 3E-4 W, see 177Re C 4E+2 2E-7 6E-10 C C 75 Rhenium-184 D, see 177Re 2E+3 4E+3 1E-6 5E-9 3E-5 3E-4 W, see 177Re C 1E+3 6E-7 2E-9 C C Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml) 75 Rhenium-186m D, see 177Re 1E+3 2E+3 7E-7 C C C St wall St wall (2E+3) (2E+3) C 3E-9 2E-5 2E-4 W, see 177Re C 2E+2 6E-8 2E-10 C C 75 Rhenium-186 D, see 177Re 2E+3 3E+3 1E-6 4E-9 3E-5 3E-4 W, see 177Re C 2E+3 7E-7 2E-9 C C 75 Rhenium-187 D, see 177Re 6E+5 8E+5 4E-4 C 8E-3 8E-2 C (9E+5) C 1E-6 C C W, see 177Re C 1E+5 4E-5 1E-7 C C 75 Rhenium-188mb/ D, see 177Re 8E+4 1E+5 6E-5 2E-7 1E-3 1E-2 W, see 177Re C 1E+5 6E-5 2E-7 C C 75 Rhenium-188 D, see 177Re 2E+3 3E+3 1E-6 4E-9 2E-5 2E-4 W, see 177Re C 3E+3 1E-6 4E-9 C C 75 Rhenium-189 D, see 177Re 3E+3 5E+3 2E-6 7E-9 4E-5 4E-4 W, see 177Re C 4E+3 2E-6 6E-9 C C 76 Osmium-180b D, all compounds except those given for W and Y 1E+5 4E+5 2E-4 5E-7 1E-3 1E-2 W, halides and nitrates C 5E+5 2E-4 7E-7 C C Y, oxides and hydroxides C 5E+5 2E-4 6E-7 C C 76 Osmium-181b D, see 180Os 1E+4 4E+4 2E-5 6E-8 2E-4 2E-3 W, see 180Os C 5E+4 2E-5 6E-8 C C Y, see 180Os C 4E+4 2E-5 6E-8 C C 76 Osmium-182 D, see 180Os 2E+3 6E+3 2E-6 8E-9 3E-5 3E-4 W, see 180Os C 4E+3 2E-6 6E-9 C C Y, see 180Os C 4E+3 2E-6 6E-9 C C 76 Osmium-185 D, see 180Os 2E+3 5E+2 2E-7 7E-10 3E-5 3E-4 W, see 180Os C 8E+2 3E-7 1E-9 C C Y, see 180Os C 8E+2 3E-7 1E-9 C C 76 Osmium-189m D, see 180Os 8E+4 2E+5 1E-4 3E-7 1E-3 1E-2 W, see 180Os C 2E+5 9E-5 3E-7 C C Y, see 180Os C 2E+5 7E-5 2E-7 C C 76 Osmium-191m D, see 180Os 1E+4 3E+4 1E-5 4E-8 2E-4 2E-3 W, see 180Os C 2E+4 8E-6 3E-8 C C Y, see 180Os C 2E+4 7E-6 2E-8 C C 76 Osmium-191 D, see 180Os 2E+3 2E+3 9E-7 3E-9 C C (3E+3) C C C 3E-5 3E-4 W, see 180Os C 2E+3 7E-7 2E-9 C C Y, see 180Os C 1E+3 6E-7 2E-9 C C 76 Osmium-193 D, see 180Os 2E+3 5E+3 2E-6 6E-9 C C (2E+3) C C C 2E-5 2E-4 W, see 180Os C 3E+3 1E-6 4E-9 C C Y, see 180Os C 3E+3 1E-6 4E-9 C C 76 Osmium-194 D, see 180Os 4E+2 4E+1 2E-8 6E-11 C C W, see 180Os C 6E+1 2E-8 8E-11 C C Y, see 180Os C 8E+0 3E-9 1E-11 C C Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml) 77 Iridium-182b D, all compounds except those given for W and Y 4E+4 1E+5 6E-5 2E-7 C C W, halides, nitrates, and metallic iridium C 2E+5 6E-5 2E-7 C C Y, oxides and hydroxides C 1E+5 5E-5 2E-7 C C 77 Iridium-184 D, see 182Ir 8E+3 2E+4 1E-5 3E-8 1E-4 1E-3 W, see 182Ir C 3E+4 1E-5 5E-8 C C Y, see 182Ir C 3E+4 1E-5 4E-8 C C 77 Iridium-185 D, see 182Ir 5E+3 1E+4 5E-6 2E-8 7E-5 7E-4 W, see 182Ir C 1E+4 5E-6 2E-8 C C Y, see 182Ir C 1E+4 4E-6 1E-8 C C 77 Iridium-186 D, see 182Ir 2E+3 8E+3 3E-6 1E-8 3E-5 3E-4 W, see 182Ir C 6E+3 3E-6 9E-9 C C Y, see 182Ir C 6E+3 2E-6 8E-9 C C 77 Iridium-187 D, see 182Ir 1E+4 3E+4 1E-5 5E-8 1E-4 1E-3 W, see 182Ir C 3E+4 1E-5 4E-8 C C Y, see 182Ir C 3E+4 1E-5 4E-8 C C 77 Iridium-188 D, see 182Ir 2E+3 5E+3 2E-6 6E-9 3E-5 3E-4 W, see 182Ir C 4E+3 1E-6 5E-9 C C Y, see 182Ir C 3E+3 1E-6 5E-9 C C 77 Iridium-189 D, see 182Ir 5E+3 5E+3 2E-6 7E-9 C C (5E+3) C C C 7E-5 7E-4 W, see 182Ir C 4E+3 2E-6 5E-9 C C Y, see 182Ir C 4E+3 1E-6 5E-9 C C 77 Iridium-190mb D, see 182Ir 2E+5 2E+5 8E-5 3E-7 2E-3 2E-2 W, see 182Ir C 2E+5 9E-5 3E-7 C C Y, see 182Ir C 2E+5 8E-5 3E-7 C C 77 Iridium-190 D, see 182Ir 1E+3 9E+2 4E-7 1E-9 1E-5 1E-4 W, see 182Ir C 1E+3 4E-7 1E-9 C C Y, see 182Ir C 9E+2 4E-7 1E-9 C C 77 Iridium-192m D, see 182Ir 3E+3 9E+1 4E-8 1E-10 4E-5 4E-4 W, see 182Ir C 2E+2 9E-8 3E-10 C C Y, see 182Ir C 2E+1 6E-9 2E-11 C C 77 Iridium-192 D, see 182Ir 9E+2 3E+2 1E-7 4E-10 1E-5 1E-4 W, see 182Ir C 4E+2 2E-7 6E-10 C C Y, see 182Ir C 2E+2 9E-8 3E-10 C C 77 Iridium-194m D, see 182Ir 6E+2 9E+1 4E-8 1E-10 9E-6 9E-5 W, see 182Ir C 2E+2 7E-8 2E-10 C C Y, see 182Ir C 1E+2 4E-8 1E-10 C C 77 Iridium-194 D, see 182Ir 1E+3 3E+3 1E-6 4E-9 1E-5 1E-4 W, see 182Ir C 2E+3 9E-7 3E-9 C C Y, see 182Ir C 2E+3 8E-7 3E-9 C C 77 Iridium-195m D, see 182Ir 8E+3 2E+4 1E-5 3E-8 1E-4 1E-3 W, see 182Ir C 3E+4 1E-5 4E-8 C C Y, see 182Ir C 2E+4 9E-6 3E-8 C C Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml) 77 Iridium-195 D, see 182Ir 1E+4 4E+4 2E-5 6E-8 2E-4 2E-3 W, see 182Ir C 5E+4 2E-5 7E-8 C C Y, see 182Ir C 4E+4 2E-5 6E-8 C C 78 Platinum-186 D, all compounds 1E+4 4E+4 2E-5 5E-8 2E-4 2E-3 78 Platinum-188 D, all compounds 2E+3 2E+3 7E-7 2E-9 2E-5 2E-4 78 Platinum-189 D, all compounds 1E+4 3E+4 1E-5 4E-8 1E-4 1E-3 78 Platinum-191 D, all compounds 4E+3 8E+3 4E-6 1E-8 5E-5 5E-4 78 Platinum-193m D, all compounds 3E+3 6E+3 3E-6 8E-9 C C (3E+4) C C C 4E-5 4E-4 78 Platinum-193 D, all compounds 4E+4 2E+4 1E-5 3E-8 C C (5E+4) C C C 6E-4 6E-3 78 Platinum-195m D, all compounds 2E+3 4E+3 2E-6 6E-9 C C 78 Platinum-197mb D, all compounds 2E+4 4E+4 2E-5 6E-8 2E-4 2E-3 78 Platinum-197 D, all compounds 3E+3 1E+4 4E-6 1E-8 4E-5 4E-4 78 Platinum-199b D, all compounds 5E+4 1E+5 6E-5 2E-7 7E-4 7E-3 78 Platinum-200 D, all compounds 1E+3 3E+3 1E-6 5E-9 2E-5 2E-4 79 Gold-193 D, all compounds except those given for W and Y 9E+3 3E+4 1E-5 4E-8 1E-4 1E-3 W, halides and nitrates C 2E+4 9E-6 3E-8 C C Y, oxides and hydroxides C 2E+4 8E-6 3E-8 C C 79 Gold-194 D, see 193Au 3E+3 8E+3 3E-6 1E-8 4E-5 4E-4 W, see 193Au C 5E+3 2E-6 8E-9 C C Y, see 193Au C 5E+3 2E-6 7E-9 C C 79 Gold-195 D, see 193Au 5E+3 1E+4 5E-6 2E-8 7E-5 7E-4 W, see 193Au C 1E+3 6E-7 2E-9 C C Y, see 193Au C 4E+2 2E-7 6E-10 C C 79 Gold-198m D, see 193Au 1E+3 3E+3 1E-6 4E-9 1E-5 1E-4 W, see 193Au C 1E+3 5E-7 2E-9 C C Y, see 193Au C 1E+3 5E-7 2E-9 C C 79 Gold-198 D, see 193Au 1E+3 4E+3 2E-6 5E-9 2E-5 2E-4 W, see 193Au C 2E+3 8E-7 3E-9 C C Y, see 193Au C 2E+3 7E-7 2E-9 C C 79 Gold-199 D, see 193Au 3E+3 9E+3 4E-6 1E-8 C C W, see 193Au C 4E+3 2E-6 6E-9 C C Y, see 193Au C 4E+3 2E-6 5E-9 C C 79 Gold-200m D, see 193Au 1E+3 4E+3 1E-6 5E-9 2E-5 2E-4 W, see 193Au C 3E+3 1E-6 4E-9 C C Y, see 193Au C 2E+4 1E-6 3E-9 C C Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml) 79 Gold-200b D, see 193Au 3E+4 6E+4 3E-5 9E-8 4E-4 4E-3 W, see 193Au C 8E+4 3E-5 1E-7 C C Y, see 193Au C 7E+4 3E-5 1E-7 C C 79 Gold-201b D, see 193Au 7E+4 2E+5 9E-5 3E-7 C C W, see 193Au C 2E+5 1E-4 3E-7 C C Y, see 193Au C 2E+5 9E-5 3E-7 C C 80 Mercury-193m Vapor C 8E+3 4E-6 1E-8 C C Organic D 4E+3 1E+4 5E-6 2E-8 6E-5 6E-4 D, sulfates 3E+3 9E+3 4E-6 1E-8 4E-5 4E-4 halides, nitrates, and sulfides C 8E+3 3E-6 1E-8 C C 80 Mercury-193 Vapor C 3E+4 1E-5 4E-8 C C Organic D 2E+4 6E+4 3E-5 9E-8 3E-4 3E-3 D, see 193mHg 2E+4 4E+4 2E-5 6E-8 2E-4 2E-3 W, see 193mHg C 4E+4 2E-5 6E-8 C C 80 Mercury-194 Vapor C 3E+1 1E-8 4E-11 C C Organic D 2E+1 3E+1 1E-8 4E-11 2E-7 2E-6 D, see 193mHg 8E+2 4E+1 2E-8 6E-11 1E-5 1E-4 W, see 193mHg C 1E+2 5E-8 2E-10 C C 80 Mercury-195m Vapor C 4E+3 2E-6 6E-9 C C Organic D 3E+3 6E+3 3E-6 8E-9 4E-5 4E-4 D, see 193mHg 2E+3 5E+3 2E-6 7E-9 3E-5 3E-4 W, see 193mHg C 4E+3 2E-6 5E-9 C C 80 Mercury-195 Vapor C 3E+4 1E-5 4E-8 C C Organic D 2E+4 5E+4 2E-5 6E-8 2E-4 2E-3 D, see 193mHg 1E+4 4E+4 1E-5 5E-8 2E-4 2E-3 W, see 193mHg C 3E+4 1E-5 5E-8 C C 80 Mercury-197m Vapor C 5E+3 2E-6 7E-9 C C Organic D 4E+3 9E+3 4E-6 1E-8 5E-5 5E-4 D, see 193mHg 3E+3 7E+3 3E-6 1E-8 4E-5 4E-4 W, see 193mHg C 5E+3 2E-6 7E-9 C C 80 Mercury-197 Vapor C 8E+3 4E-6 1E-8 C C Organic D 7E+3 1E+4 6E-6 2E-8 9E-5 9E-4 D, see 193mHg 6E+3 1E+4 5E-6 2E-8 8E-5 8E-4 W, see 193mHg C 9E+3 4E-6 1E-8 C C 80 Mercury-199mb Vapor C 8E+4 3E-5 1E-7 C C Organic D 6E+4 2E+5 7E-5 2E-7 C C (1E+5) C C C 1E-3 1E-2 D, see 193mHg 6E+4 1E+5 6E-5 2E-7 8E-4 8E-3 W, see 193mHg C 2E+5 7E-5 2E-7 C C 80 Mercury-203 Vapor C 8E+2 4E-7 1E-9 C C Organic D 5E+2 8E+2 3E-7 1E-9 7E-6 7E-5 D, see 193mHg 2E+3 1E+3 5E-7 2E-9 3E-5 3E-4 W, see 193mHg C 1E+3 5E-7 2E-9 C C 81 Thallium-194mb D, all compounds 5E+4 2E+5 6E-5 2E-7 C C Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml) 81 Thallium-194b D, all compounds 3E+5 6E+5 2E-4 8E-7 C C (3E+5) C C C 4E-3 4E-2 81 Thallium-195b D, all compounds 6E+4 1E+5 5E-5 2E-7 9E-4 9E-3 81 Thallium-197 D, all compounds 7E+4 1E+5 5E-5 2E-7 1E-3 1E-2 81 Thallium-198mb/ D, all compounds 3E+4 5E+4 2E-5 8E-8 4E-4 4E-3 81 Thallium-198 D, all compounds 2E+4 3E+4 1E-5 5E-8 3E-4 3E-3 81 Thallium-199 D, all compounds 6E+4 8E+4 4E-5 1E-7 9E-4 9E-3 81 Thallium-200 D, all compounds 8E+3 1E+4 5E-6 2E-8 1E-4 1E-3 81 Thallium-201 D, all compounds 2E+4 2E+4 9E-6 3E-8 2E-4 2E-3 81 Thallium-202 D, all compounds 4E+3 5E+3 2E-6 7E-9 5E-5 5E-4 81 Thallium-204 D, all compounds 2E+3 2E+3 9E-7 3E-9 2E-5 2E-4 82 Lead-195mb D, all compounds 6E+4 2E+5 8E-5 3E-7 8E-4 8E-3 82 Lead-198 D, all compounds 3E+4 6E+4 3E-5 9E-8 4E-4 4E-3 82 Lead-199b D, all compounds 2E+4 7E+4 3E-5 1E-7 3E-4 3E-3 82 Lead-200 D, all compounds 3E+3 6E+3 3E-6 9E-9 4E-5 4E-4 82 Lead-201 D, all compounds 7E+3 2E+4 8E-6 3E-8 1E-4 1E-3 82 Lead-202m D, all compounds 9E+3 3E+4 1E-5 4E-8 1E-4 1E-3 82 Lead-202 D, all compounds 1E+2 5E+1 2E-8 7E-11 2E-6 2E-5 82 Lead-203 D, all compounds 5E+3 9E+3 4E-6 1E-8 7E-5 7E-4 82 Lead-205 D, all compounds 4E+3 1E+3 6E-7 2E-9 5E-5 5E-4 82 Lead-209 D, all compounds 2E+4 6E+4 2E-5 8E-8 3E-4 3E-3 82 Lead-210 D, all compounds 6E-1 2E-1 1E-10 C C C (1E+0) (4E-1) C 6E-13 1E-8 1E-7 82 Lead-211b D, all compounds 1E+4 6E+2 3E-7 9E-10 2E-4 2E-3 82 Lead-212 D, all compounds 8E+1 3E+1 1E-8 5E-11 C C (1E+2) C C C 2E-6 2E-5 82 Lead-214b D, all compounds 9E+3 8E+2 3E-7 1E-9 1E-4 1E-3 83 Bismuth-200b D, nitrates 3E+4 8E+4 4E-5 1E-7 4E-4 4E-3 W, all other compounds C 1E+5 4E-5 1E-7 C C 83 Bismuth-201b/ D, see 200Bi 1E+4 3E+4 1E-5 4E-8 2E-4 2E-3 W, see 200Bi C 4E+4 2E-5 5E-8 C C 83 Bismuth-202b/ D, see 200Bi 1E+4 4E+4 2E-5 6E-8 2E-4 2E-3 W, see 200Bi C 8E+4 3E-5 1E-7 C C Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml) 83 Bismuth-203 D, see 200Bi 2E+3 7E+3 3E-6 9E-9 3E-5 3E-4 W, see 200Bi C 6E+3 3E-6 9E-9 C C 83 Bismuth-205 D, see 200Bi 1E+3 3E+3 1E-6 3E-9 2E-5 2E-4 W, see 200Bi C 1E+3 5E-7 2E-9 C C 83 Bismuth-206 D, see 200Bi 6E+2 1E+3 6E-7 2E-9 9E-6 9E-5 W, see 200Bi C 9E+2 4E-7 1E-9 C C 83 Bismuth-207 D, see 200Bi 1E+3 2E+3 7E-7 2E-9 1E-5 1E-4 W, see 200Bi C 4E+2 1E-7 5E-10 C C 83 Bismuth-210m D, see 200Bi 4E+1 5E+0 2E-9 C C C Kidneys Kidneys (6E+1) (6E+0) C 9E-12 8E-7 8E-6 W, see 200Bi C 7E-1 3E-10 9E-13 C C 83 Bismuth-210 D, see 200Bi 8E+2 2E+2 1E-7 C 1E-5 1E-4 C Kidneys C (4E+2) C 5E-10 C C W, see 200Bi C 3E+1 1E-8 4E-11 C C 83 Bismuth-212b D, see 200Bi 5E+3 2E+2 1E-7 3E-10 7E-5 7E-4 W, see 200Bi C 3E+2 1E-7 4E-10 C C 83 Bismuth-213b D, see 200Bi 7E+3 3E+2 1E-7 4E-10 1E-4 1E-3 W, see 200Bi C 4E+2 1E-7 5E-10 C C 83 Bismuth-214b D, see 200Bi 2E+4 8E+2 3E-7 1E-9 C C (2E+4) C C C 3E-4 3E-3 W, see 200Bi C 9E-2 4E-7 1E-9 C C 84 Polonium-203b D, all compounds except those given for W 3E+4 6E+4 3E-5 9E-8 3E-4 3E-3 and nitrates C 9E+4 4E-5 1E-7 C C 84 Polonium-205b D, see 203Po 2E+4 4E+4 2E-5 5E-8 3E-4 3E-3 W, see 203Po C 7E+4 3E-5 1E-7 C C 84 Polonium-207 D, see 203Po 8E+3 3E+4 1E-5 3E-8 1E-4 1E-3 W, see 203Po C 3E+4 1E-5 4E-8 C C 84 Polonium-210 D, see 203Po 3E+0 6E-1 3E-10 9E-13 4E-8 4E-7 W, see 203Po C 6E-1 3E-10 9E-13 C C 85 Astatine-207b D, halides 6E+3 3E+3 1E-6 4E-9 8E-5 8E-4 W C 2E+3 9E-7 3E-9 C C 85 Astatine-211 D, halides 1E+2 8E+1 3E-8 1E-10 2E-6 2E-5 W C 5E+1 2E-8 8E-11 C C 86 Radon-220 With daughters removed C 2E+4 7E-6 2E-8 C C With daughters present C 2E+1 9E-9 3E-11 C C (or 12 (or 1.0 WLM) WL) 86 Radon-222 With daughters removed C 1E+4 4E-6 1E-8 C C With daughters present C 1E+2 3E-8 1E-10 C C (or 4 (or 0.33 WLM) WL)
Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml) 87 Francium-222b/ D, all compounds 2E+3 5E+2 2E-7 6E-10 3E-5 3E-4 87 Francium-223b/ D, all compounds 6E+2 8E+2 3E-7 1E-9 8E-6 8E-5 88 Radium-223 W, all compounds 5E+0 7E-1 3E-10 9E-13 C C (9E+0) C C C 1E-7 1E-6 88 Radium-224 W, all compounds 8E+0 2E+0 7E-10 2E-12 C C (2E+1) C C C 2E-7 2E-6 88 Radium-225 W, all compounds 8E+0 7E-1 3E-10 9E-13 C C (2E+1) C C C 2E-7 2E-6 88 Radium-226 W, all compounds 2E+0 6E-1 3E-10 9E-13 C C (5E+0) C C C 6E-8 6E-7 88 Radium-227b W, all compounds 2E+4 1E+4 6E-6 C C C (2E+4) (2E+4) C 3E-8 3E-4 3E-3 88 Radium-228 W, all compounds 2E+0 1E+0 5E-10 2E-12 C C (4E+0) C C C 6E-8 6E-7 89 Actinium-224 D, all compounds except those given for W and Y 2E+3 3E+1 1E-8 C C C (2E+3) (4E+1) C 5E-11 3E-5 3E-4 W, halides and nitrates C 5E+1 2E-8 7E-11 C C Y, oxides and hydroxides C 5E+1 2E-8 6E-11 C C 89 Actinium-225 D, see 224Ac 5E+1 3E-1 1E-10 C C C (5E+1) (5E-1) C 7E-13 7E-7 7E-6 W, see 224Ac C 6E-1 3E-10 9E-13 C C Y, see 224Ac C 6E-1 3E-10 9E-13 C C 89 Actinium-226 D, see 224Ac 1E+2 3E+0 1E-9 C C C (1E+2) (4E+0) C 5E-12 2E-6 2E-5 W, see 224Ac C 5E+0 2E-9 7E-12 C C Y, see 224Ac C 5E+0 2E-9 6E-12 C C 89 Actinium-227 D, see 224Ac 2E-1 4E-4 2E-13 C C C (4E-1) (8E-4) C 1E-15 5E-9 5E-8 W, see 224Ac C 2E-3 7E-13 C C C C (3E-3) C 4E-15 C C Y, see 224Ac C 4E-3 2E-12 6E-15 C C 89 Actinium-228 D, see 224Ac 2E+3 9E+0 4E-9 C 3E-5 3E-4 C (2E+1) C 2E-11 C C W, see 224Ac C 4E+1 2E-8 C C C C (6E+1) C 8E-11 C C Y, see 224Ac C 4E+1 2E-8 6E-11 C C Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml) 90 Thorium-226b W, all compounds except those given for Y 5E+3 2E+2 6E-8 2E-10 C C (5E+3) C C C 7E-5 7E-4 Y, oxides and hydroxides C 1E+2 6E-8 2E-10 C C 90 Thorium-227 W, see 226Th 1E+2 3E-1 1E-10 5E-13 2E-6 2E-5 Y, see 226Th C 3E-1 1E-10 5E-13 C C 90 Thorium-228 W, see 226Th 6E+0 1E-2 4E-12 C C C (1E+1) (2E-2) C 3E-14 2E-7 2E-6 Y, see 226Th C 2E-2 7E-12 2E-14 C C 90 Thorium-229 W, see 226Th 6E-1 9E-4 4E-13 C C C (1E+0) (2E-3) C 3E-15 2E-8 2E-7 Y, see 226Th C 2E-3 1E-12 C C C C (3E-3) C 4E-15 C C 90 Thorium-230 W, see 226Th 4E+0 6E-3 3E-12 C C C (9E+0) (2E-2) C 2E-14 1E-7 1E-6 Y, see 226Th C 2E-2 6E-12 C C C C (2E-2) C 3E-14 C C 90 Thorium-231 W, see 226Th 4E+3 6E+3 3E-6 9E-9 5E-5 5E-4 Y, see 226Th C 6E+3 3E-6 9E-9 C C 90 Thorium-232 W, see 226Th 7E-1 1E-3 5E-13 C C C (2E+0) (3E-3) C 4E-15 3E-8 3E-7 Y, see 226Th C 3E-3 1E-12 C C C - (4E-3) C 6E-15 C C 90 Thorium-234 W, see 226Th 3E+2 2E+2 8E-8 3E-10 C C (4E+2) C C C 5E-6 5E-5 Y, see 226Th C 2E+2 6E-8 2E-10 C C 91 Protactinium-227b W, all compounds except those given for Y 4E+3 1E+2 5E-8 2E-10 5E-5 5E-4 Y, oxides and hydroxides C 1E+2 4E-8 1E-10 C C 91 Protactinium-228 W, see 227Pa 1E+3 1E+1 5E-9 C 2E-5 2E-4 C (2E+1) C 3E-11 C C Y, see 227Pa C 1E+1 5E-9 2E-11 C C 91 Protactinium-230 W, see 227Pa 6E+2 5E+0 2E-9 7E-12 C C (9E+2) C C C 1E-5 1E-4 Y, see 227Pa C 4E+0 1E-9 5E-12 C C 91 Protactinium-231 W, see 227Pa 2E-1 2E-3 6E-13 C C C (5E-1) (4E-3) C 6E-15 6E-9 6E-8 Y, see 227Pa C 4E-3 2E-12 C C C C (6E-3) C 8E-15 C C Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml) 91 Protactinium-232 W, see 227Pa 1E+3 2E+1 9E-9 C 2E-5 2E-4 C (6E+1) C 8E-11 C C Y, see 227Pa C 6E+1 2E-8 C C C C (7E+1) C 1E-10 C C 91 Protactinium-233 W, see 227Pa 1E+3 7E+2 3E-7 1E-9 C C (2E+3) C C C 2E-5 2E-4 Y, see 227Pa C 6E+2 2E-7 8E-10 C C 91 Protactinium-234 W, see 227Pa 2E+3 8E+3 3E-6 1E-8 3E-5 3E-4 Y, see 227Pa C 7E+3 3E-6 9E-9 C C 92 Uranium-230 D, UF6, UO2F2, UO2,(NO3)2 4E+0 4E-1 2E-10 C C C (6E+0) (6E-1) C 8E-13 8E-8 8E-7 W, UO3, UF4, UCl4 C 4E-1 1E-10 5E-13 C C Y, UO2, U3O8 C 3E-1 1E-10 4E-13 C C 92 Uranium-231 D, see 230U 5E+3 8E+3 3E-6 1E-8 C C (4E+3) C C C 6E-5 6E-4 W, see 230U C 6E+3 2E-6 8E-9 C C Y, see 230U C 5E+3 2E-6 6E-9 C C 92 Uranium-232 D, see 230U 2E+0 2E-1 9E-11 C C C (4E+0) (4E-1) C 6E-13 6E-8 6E-7 W, see 230U C 4E-1 2E-10 5E-13 C C Y, see 230U C 8E-3 3E-12 1E-14 C C 92 Uranium-233 D, see 230U 1E+1 1E+0 5E-10 C C C W, see 230U C 7E-1 3E-10 1E-12 C C Y, see 230U C 4E-2 2E-11 5E-14 C C 92 Uranium-234c D, see 230U 1E+1 1E+0 5E-10 C C C W, see 230U C 7E-1 3E-10 1E-12 C C Y, see 230U C 4E-2 2E-11 5E-14 C C 92 Uranium-235c/ D, see 230U 1E+1 1E+0 6E-10 C C C W, see 230U C 8E-1 3E-10 1E-12 C C Y, see 230U C 4E-2 2E-11 6E-14 C C 92 Uranium-236 D, see 230U 1E+1 1E+0 5E-10 C C C W, see 230U C 8E-1 3E-10 1E-12 C C Y, see 230U C 4E-2 2E-11 6E-14 C C 92 Uranium-237 D, see 230U 2E+3 3E+3 1E-6 4E-9 C C W, see 230U C 2E+3 7E-7 2E-9 C C Y, see 230U C 2E+3 6E-7 2E-9 C C Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml) 92 Uranium-238c D, see 230U 1E+1 1E+0 6E-10 C C C W, see 230U C 8E-1 3E-10 1E-12 C C Y, see 230U C 4E-2 2E-11 6E-14 C C 92 Uranium-239b D, see 230U 7E+4 2E+5 8E-5 3E-7 9E-4 9E-3 W, see 230U C 2E+5 7E-5 2E-7 C C Y, see 230U C 2E+5 6E-5 2E-7 C C 92 Uranium-240 D, see 230U 1E+3 4E+3 2E-6 5E-9 2E-5 2E-4 W, see 230U C 3E+3 1E-6 4E-9 C C Y, see 230U C 2E+3 1E-6 3E-9 C C 92 Uranium-naturalc D, see 230U 1E+1 1E+0 5E-10 C C C W, see 230U C 8E-1 3E-10 9E-13 C C Y, see 230U C 5E-2 2E-11 9E-14 C C 93 Neptunium-232b W, all compounds 1E+5 2E+3 7E-7 C 2E-3 2E-2 __ (5E+2) C 6E-9 - C 93 Neptunium-233b W, all compounds 8E+5 3E+6 1E-3 4E-6 1E-2 1E-1 93 Neptunium-234 W, all compounds 2E+3 3E+3 1E-6 4E-9 3E-5 3E-4 93 Neptunium-235 W, all compounds 2E+4 8E+2 3E-7 C C C (2E+4) (1E+3) C 2E-9 3E-4 3E-3 93 Neptunium-236 W, all compounds 3E+0 2E-2 9E-12 C C C (1.15E+5 y) Bone surf Bone surf (6E+0) (5E-2) C 8E-14 9E-8 9E-7 93 Neptunium-236 W, all compounds 3E+3 3E+1 1E-8 C C C (22.5 h) Bone surf Bone surf (4E+3) (7E+1) C 1E-10 5E-5 5E-4 93 Neptunium-237 W, all compounds 5E-1 4E-3 2E-12 C C C (1E+0) (1E-2) C 1E-14 2E-8 2E-7 93 Neptunium-238 W, all compounds 1E+3 6E+1 3E-8 C 2E-5 2E-4 __ (2E+2) C 2E-10 __ C 93 Neptunium-239 W, all compounds 2E+3 2E+3 9E-7 3E-9 C C (2E+3) C C C 2E-5 2E-4 93 Neptunium-240b W, all compounds 2E+4 8E+4 3E-5 1E-7 3E-4 3E-3 94 Plutonium-234 W, all compounds except PuO2 8E+3 2E+2 9E-8 3E-10 1E-4 1E-3 Y, PuO2 C 2E+2 8E-8 3E-10 C C 94 Plutonium-235b W, see 234Pu 9E+5 3E+6 1E-3 4E-6 1E-2 1E-1 Y, see 234Pu C 3E+6 1E-3 3E-6 C C Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml) 94 Plutonium-236 W, see 234Pu 2E+0 2E-2 8E-12 C C C (4E+0) (4E-2) C 5E-14 6E-8 6E-7 Y, see 234Pu C 4E-2 2E-11 6E-14 C C 94 Plutonium-237 W, see 234Pu 1E+4 3E+3 1E-6 5E-9 2E-4 2E-3 Y, see 234Pu C 3E+3 1E-6 4E-9 C C 94 Plutonium-238 W, see 234Pu 9E-1 7E-3 3E-12 C C C (2E+0) (1E-2) C 2E-14 2E-8 2E-7 Y, see 234Pu C 2E-2 8E-12 2E-14 C C 94 Plutonium-239 W, see 234Pu 8E-1 6E-3 3E-12 C C C Y, see 234Pu C 2E-2 7E-12 C C C C (2E-2) C 2E-14 C C 94 Plutonium-240 W, see 234Pu 8E-1 6E-3 3E-12 C C C Y, see 234Pu C 2E-2 7E-12 C C C C (2E-2) C 2E-14 C C 94 Plutonium-241 W, see 234Pu 4E+1 3E-1 1E-10 C C C (7E+1) (6E-1) C 8E-13 1E-6 1E-5 Y, see 234Pu C 8E-1 3E-10 C C C C (1E+0) C 1E-12 C C 94 Plutonium-242 W, see 234Pu 8E-1 7E-3 3E-12 C C C Y, see 234Pu C 2E-2 7E-12 C C C C (2E-2) C 2E-14 C C 94 Plutonium-243 W, see 234Pu 2E+4 4E+4 2E-5 5E-8 2E-4 2E-3 Y, see 234Pu C 4E+4 2E-5 5E-8 C C 94 Plutonium-244 W, see 234Pu 8E-1 7E-3 3E-12 C C C (2E+0) (1E-2) C 2E-14 2E-8 2E-7 Y, see 234Pu C 2E-2 7E-12 C C C C (2E-2) C 2E-14 C C 94 Plutonium-245 W, see 234Pu 2E+3 5E+3 2E-6 6E-9 3E-5 3E-4 Y, see 234Pu C 4E+3 2E-6 6E-9 C C 94 Plutonium-246 W, see 234Pu 4E+2 3E+2 1E-7 4E-10 C C (4E+2) C C C 6E-6 6E-5 Y, see 234Pu C 3E+2 1E-7 4E-10 C C 95 Americium-237b W, all compounds 8E+4 3E+5 1E-4 4E-7 1E-3 1E-2 95 Americium-238b W, all compounds 4E+4 3E+3 1E-6 C 5E-4 5E-3 C (6E+3) C 9E-9 C C Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml) 95 Americium-239 W, all compounds 5E+3 1E+4 5E-6 2E-8 7E-5 7E-4 95 Americium-240 W, all compounds 2E+3 3E+3 1E-6 4E-9 3E-5 3E-4 95 Americium-241 W, all compounds 8E-1 6E-3 3E-12 C C C 95 Americium-242m W, all compounds 8E-1 6E-3 3E-12 C C C 95 Americium-242 W, all compounds 4E+3 8E+1 4E-8 C 5E-5 5E-4 C (9E+1) C 1E-10 C C 95 Americium-243 W, all compounds 8E-1 6E-3 3E-12 C C C 95 Americium-244mb/ W, all compounds 6E+4 4E+3 2E-6 C C C St wall Bone surf (8E+4) (7E+3) C 1E-8 1E-3 1E-2 95 Americium-244 W, all compounds 3E+3 2E+2 8E-8 C 4E-5 4E-4 C (3E+2) C 4E-10 C C 95 Americium-245 W, all compounds 3E+4 8E+4 3E-5 1E-7 4E-4 4E-3 95 Americium-246mb W, all compounds 5E+4 2E+5 8E-5 3E-7 C C 95 Americium-246b W, all compounds 3E+4 1E+5 4E-5 1E-7 4E-4 4E-3 96 Curium-238 W, all compounds 2E+4 1E+3 5E-7 2E-9 2E-4 2E-3 96 Curium-240 W, all compounds 6E+1 6E-1 2E-10 C C C (8E+1) (6E-1) C 9E-13 1E-6 1E-5 96 Curium-241 W, all compounds 1E+3 3E+1 1E-8 C 2E-5 2E-4 C (4E+1) C 5E-11 C C 96 Curium-242 W, all compounds 3E+1 3E-1 1E-10 C C C (5E+1) (3E-1) C 4E-13 7E-7 7E-6 96 Curium-243 W, all compounds 1E+0 9E-3 4E-12 C C C (2E+0) (2E-2) C 2E-14 3E-8 3E-7 96 Curium-244 W, all compounds 1E+0 1E-2 5E-12 C C C (3E+0) (2E-2) C 3E-14 3E-8 3E-7 96 Curium-245 W, all compounds 7E-1 6E-3 3E-12 C C C Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml) 96 Curium-246 W, all compounds 7E-1 6E-3 3E-12 C C C 96 Curium-247 W, all compounds 8E-1 6E-3 3E-12 C C C 96 Curium-248 W, all compounds 2E-1 2E-3 7E-13 C C C (4E-1) (3E-3) C 4E-15 5E-9 5E-8 96 Curium-249b W, all compounds 5E+4 2E+4 7E-6 C 7E-4 7E-3 C (3E+4) C 4E-8 C C 96 Curium-250 W, all compounds 4E-2 3E-4 1E-13 C C C (6E-2) (5E-4) C 8E-16 9E-10 9E-9 97 Berkelium-245 W, all compounds 2E+3 1E+3 5E-7 2E-9 3E-5 3E-4 97 Berkelium-246 W, all compounds 3E+3 3E+3 1E-6 4E-9 4E-5 4E-4 97 Berkelium-247 W, all compounds 5E-1 4E-3 2E-12 C C C (1E+0) (9E-3) C 1E-14 2E-8 2E-7 97 Berkelium-249 W, all compounds 2E+2 2E+0 7E-10 C C C (5E+2) (4E+0) C 5E-12 6E-6 6E-5 97 Berkelium-250 W, all compounds 9E+3 3E+2 1E-7 C 1E-4 1E-3 C (7E+2) C 1E-9 C C 98 Californium-244b W, all compounds except those given for Y 3E+4 6E+2 2E-7 8E-10 C C Y, oxides and hydroxides C 6E+2 2E-7 8E-10 C C 98 Californium-246 W, see 244Cf 4E+2 9E+0 4E-9 1E-11 5E-6 5E-5 Y, see 244Cf C 9E+0 4E-9 1E-11 C C 98 Californium-248 W, see 244Cf 8E+0 6E-2 3E-11 C C C (2E+1) (1E-1) C 2E-13 2E-7 2E-6 Y, see 244Cf C 1E-1 4E-11 1E-13 C C 98 Californium-249 W, see 244Cf 5E-1 4E-3 2E-12 C C C (1E+0) (9E-3) C 1E-14 2E-8 2E-7 Y, see 244Cf C 1E-2 4E-12 C C C C (1E-2) C 2E-14 C C 98 Californium-250 W, see 244Cf 1E+0 9E-3 4E-12 C C C (2E+0) (2E-2) C 3E-14 3E-8 3E-7 Y, see 244Cf C 3E-2 1E-11 4E-14 C C Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml) 98 Californium-251 W, see 244Cf 5E-1 4E-3 2E-12 C C C (1E+0) (9E-3) C 1E-14 2E-8 2E-7 Y, see 244Cf C 1E-2 4E-12 C C C C (1E-2) C 2E-14 C C 98 Californium-252 W, see 244Cf 2E+0 2E-2 8E-12 C C C (5E+0) (4E-2) C 5E-14 7E-8 7E-7 Y, see 244Cf C 3E-2 1E-11 5E-14 C C 98 Californium-253 W, see 244Cf 2E+2 2E+0 8E-10 3E-12 C C (4E+2) C C C 5E-6 5E-5 Y, see 244Cf C 2E+0 7E-10 2E-12 C C 98 Californium-254 W, see 244Cf 2E+0 2E-2 9E-12 3E-14 3E-8 3E-7 Y, see 244Cf C 2E-2 7E-12 2E-14 C C 99 Einsteinium-250 W, all compounds 4E+4 5E+2 2E-7 C 6E-4 6E-3 C (1E+3) C 2E-9 C C 99 Einsteinium-251 W, all compounds 7E+3 9E+2 4E-7 C 1E-4 1E-3 C (1E+3) C 2E-9 C C 99 Einsteinium-253 W, all compounds 2E+2 1E+0 6E-10 2E-12 2E-6 2E-5 99 Einsteinium-254m W, all compounds 3E+2 1E+1 4E-9 1E-11 C C (3E+2) C C C 4E-6 4E-5 99 Einsteinium-254 W, all compounds 8E+0 7E-2 3E-11 C C C (2E+1) (1E-1) C 2E-13 2E-7 2E-6 100 Fermium-252 W, all compounds 5E+2 1E+1 5E-9 2E-11 6E-6 6E-5 100 Fermium-253 W, all compounds 1E+3 1E+1 4E-9 1E-11 1E-5 1E-4 100 Fermium-254 W, all compounds 3E+3 9E+1 4E-8 1E-10 4E-5 4E-4 100 Fermium-255 W, all compounds 5E+2 2E+1 9E-9 3E-11 7E-6 7E-5 100 Fermium-257 W, all compounds 2E+1 2E-1 7E-11 C C C (4E+1) (2E-1) C 3E-13 5E-7 5E-6 101 Mendelevium-257 W, all compounds 7E+3 8E+1 4E-8 C 1E-4 1E-3 C (9E+1) C 1E-10 C C 101 Mendelevium-258 W, all compounds 3E+1 2E-1 1E-10 C C C (5E+1) (3E-1) C 5E-13 6E-7 6E-6 - Any single radionuclide not listed above with decay mode other than alpha emission or spontaneous fission and with radioactive halflife less than 2 hours Submersiona/ C 2E+2 1E-7 1E-9 C C Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml)
- Any single radionuclide not listed above with decay mode other than alpha emission or spontaneous fission and with radioactive halflife greater than 2 hours . . . . C 2E-1 1E-10 1E-12 1E-8 1E-7 - Any single radionuclide not listed above that decays by alpha emission or spontaneous fission, or any mixture for which either the identity or the concentration of any radionuclide in the mixture is not known . . . . C 4E-4 2E-13 1E-15 2E-9 2E-8 Footnotes: a "Submersion" means that values given are for submersion in a hemispherical semi-infinite cloud of airborne material. b These radionuclides have radiological half-lives of less than 2 hours. The total effective dose equivalent received during operations with these radionuclides might include a significant contribution from external exposure. The DAC values for all radionuclides, other than those designated Class "Submersion," are based upon the committed effective dose equivalent due to the intake of the radionuclide into the body and do NOT include potentially significant contributions to dose equivalent from external exposures. The licensee may substitute 1E-7 μCi/ml for the listed DAC to account for the submersion dose prospectively, but should use individual monitoring devices or other radiation measuring instruments that measure external exposure to demonstrate compliance with the limits. (See subsection 6.7.) c For soluble mixtures of U-238, U-234, and U-235 in air, chemical toxicity may be the limiting factor (see subsection 6.5.e.). If the percent by weight (enrichment) of U-235 is not greater than 5, the concentration value for a 40-hour workweek is 0.2 milligrams uranium per cubic meter of air average. For any enrichment, the product of the average concentration and time of exposure during a 40-hour workweek shall not exceed 8E-3 (SA) μCi-hr/ml, where SA is the specific activity of the uranium inhaled. The specific activity for natural uranium is 6.77E-7 curies per gram U. The specific activity for other mixtures of U-238, U-235, and U-234, if not known, shall be:
SA = 3.6E-7 curies/gram U U-depleted SA = [0.4 + 0.38 (enrichment) + 0.0034 (enrichment)2] E-6, enrichment > 0.72 where enrichment is the percentage by weight of U-235, expressed as percent.
Note:
-
If the identity of each radionuclide in a mixture is known but the concentration of one or more of the radionuclides in the mixture is not known, the DAC for the mixture shall be the most restrictive DAC of any radionuclide in the mixture.
-
If the identity of each radionuclide in the mixture is not known, but it is known that certain radionuclides specified in this table are not present in the mixture, the inhalation ALI, DAC, and effluent and sewage concentrations for the mixture are the lowest values specified in this table for any radionuclide that is not known to be absent from the mixture; or Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml)
If it is known that Ac-227-D and Cm-250-W are not present C 7E-4 3E-13 C C C __ If, in addition, it is known that Ac-227-W,Y, Th-229-W,Y, Th-230-W, Th-232-W,Y, Pa-231-W,Y, Np-237-W, Pu-239-W, Pu-240-W, Pu-242-W, Am-241-W, Am-242m-W, Am-243-W, Cm-245-W, Cm-246-W, Cm-247-W, Cm-248-W, Bk-247-W, Cf-249-W, and Cf-251-W are not present C 7E-3 3E-12 C C C If, in addition, it is known that Sm-146-W, Sm-147-W, Gd-148-D,W, Gd-152-D,W, Th-228-W,Y, Th-230-Y, U-232-Y, U-233-Y, U-234-Y, U-235-Y, U-236-Y, U-238-Y, Np-236-W, Pu-236-W,Y, Pu-238-W,Y, Pu-239-Y, Pu-240-Y, Pu-242-Y, Pu-244-W,Y, Cm-243-W, Cm-244-W, Cf-248-W, Cf-249-Y, Cf-250-W,Y, Cf-251-Y, Cf-252-W,Y, and Cf-254-W,Y are not present C 7E-2 3E-11 C C C If, in addition, it is known that Pb-210-D, Bi-210m-W, Po-210-D,W, Ra-223-W, Ra-225-W, Ra-226-W, Ac-225-D,W,Y, Th-227-W,Y, U-230-D,W,Y, U-232-D,W, Pu-241-W, Cm-240-W, Cm-242-W, Cf-248-Y, Es-254-W, Fm-257-W, and Md-258-W are not present C 7E-1 3E-10 C C C If, in addition, it is known that Si-32-Y, Ti-44-Y, Fe-60-D, Sr-90-Y, Zr-93-D, Cd-113m-D, Cd-113-D, In-115-D,W, La-138-D, Lu-176-W, Hf-178m-D,W, Hf-182-D,W, Bi-210m-D, Ra-224-W, Ra-228-W, Ac-226-D,W,Y, Pa-230-W,Y, U-233-D,W, U-234-D,W, U-235-D,W, U-236-D,W, U-238-D,W, Pu-241-Y, Bk-249-W, Cf-253-W,Y, and Es-253-W are not present C 7E+0 3E-9 C C C If it is known that Ac-227-D,W,Y, Th-229-W,Y, Th-232-W,Y, Pa-231-W,Y, Cm-248-W, and Cm-250-W are not present C C C 1E-14 C C If, in addition, it is known that Sm-146-W, Gd-148-D,W, Gd-152-D, Th-228-W,Y, Th-230-W,Y, U-232-Y, U-233-Y, U-234-Y, U-235-Y, U-236-Y, U-238-Y, U-Nat-Y, Np-236-W, Np-237-W, Pu-236-W,Y, Pu-238-W,Y, Pu-239-W,Y, Pu-240-W,Y, Pu-242-W,Y, Pu-244-W,Y, Am-241-W, Am-242m-W, Am-243-W, Cm-243-W, Cm-244-W, Cm-245-W, Cm-246-W, Cm-247-W, Bk-247-W, Cf-249-W,Y, Cf-250-W,Y, Cf-251-W,Y, Cf-252-W,Y, and Cf-254-W,Y are not present C C C 1E-13 C C If, in addition, it is known that Sm-147-W, Gd-152-W, Pb-210-D, Bi-210m-W, Po-210-D,W, Ra-223-W, Ra-225-W, Ra-226-W, Ac-225-D,W,Y, Th-227-W,Y, U-230-D,W,Y, U-232-D,W, U-Nat-W, Pu-241-W, Cm-240-W, Cm-242-W, Cf-248-W,Y, Es-254-W, Fm-257-W, and Md-258-W are not present C C C 1E-12 C C Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure Col. 1 Col. 2 Col. 3 Col. 1 Col. 2 No. (μCi) (μCi) (μCi/ml) (μCi/ml) (μCi/ml) (μCi/ml)
If, in addition it is known that Fe-60, Sr-90, Cd-113m, Cd-113, In-115, I-129, Cs-134, Sm-145, Sm-147, Gd-148, Gd-152, Hg-194 (organic), Bi-210m, Ra-223, Ra-224, Ra-225, Ac-225, Th-228, Th-230, U-233, U-234, U-235, U-236, U-238, U-Nat, Cm-242, Cf-248, Es-254, Fm-257, and Md-258 are not present C C C C 1E-6 1E-5 3. If a mixture of radionuclides consists of uranium and its daughters in ore dust (10 μm AMAD particle distribution assumed) prior to chemical separation of the uranium from the ore, the following values may be used for the DAC of the mixture: 6E-11 μCi of gross alpha activity from Uuranium-238, Uuranium-234, Tthorium-230, and Rradium-226 per milliliter of air; 3E-11 μCi of natural uranium per milliliter of air; or 45 micrograms of natural uranium per cubic meter of air.
- If the identity and concentration of each radionuclide in a mixture are known, the limiting values should be derived as follows: determine, for each radionuclide in the mixture, the ratio between the concentration present in the mixture and the concentration otherwise established in table 64-23 F for the specific radionuclide when not in a mixture. The sum of such ratios for all of the radionuclides in the mixture may not exceed "1" (i.e., "unity").
Example: If radionuclides "A," "B," and "C" are present in concentrations CA, CB, and CC, and if the applicable DACs are DACA, DACB, and DACC, respectively, then the concentrations shall be limited so that the following relationship exists:
__ CA + CB + CC 1
DACA DACB DACC
TABLE 64-23 E
QUANTITIES OF REGISTERED MATERIAL REQUIRING LABELING
Hydrogen-3 1,000 Beryllium-7 1,000 Beryllium-10 1 Carbon-11 1,000 Carbon-14 1,000 Fluorine-18 1,000 Sodium-22 10 Sodium-24 100 Magnesium-28 100 Aluminum-26 10 Silicon-31 1,000 Silicon-32 1 Phosphorus-32 10 Phosphorus-33 100 Sulfur-35 100 Chlorine-36 10 Chlorine-38 1,000 Chlorine-39 1,000 Argon-39 1,000 Argon-41 1,000 Potassium-40 100 Potassium-42 1,000 Potassium-43 1,000 Potassium-44 1,000 Potassium-45 1,000 Calcium-41 100 Calcium-45 100 Calcium-47 100 Scandium-43 1,000 Scandium-44m 100 Scandium-44 100 Scandium-46 10 Scandium-47 100 Scandium-48 100 Scandium-49 1,000 Titanium-44 1 Titanium-45 1,000 Vanadium-47 1,000 Vanadium-48 100 Vanadium-49 1,000 Chromium-48 1,000 Chromium-49 1,000 Chromium-51 1,000 Manganese-51 1,000 Manganese-52m 1,000 Manganese-52 100 Manganese-53 1,000 Manganese-54 100 Manganese-56 1,000 Iron-52 100 Iron-55 100 Iron-59 10 Iron-60 1 Cobalt-55 100 Cobalt-56 10 Cobalt-57 100 Cobalt-58m 1,000 Cobalt-58 100 Cobalt-60m 1,000 Cobalt-60 1 Cobalt-61 1,000 Cobalt-62m 1,000 Nickel-56 100 Nickel-57 100 Nickel-59 100 Nickel-63 100 Nickel-65 1,000 Nickel-66 10 Copper-60 1,000 Copper-61 1,000 Copper-64 1,000 Copper-67 1,000 Zinc-62 100 Zinc-63 1,000 Zinc-65 10 Zinc-69m 100 Zinc-69 1,000 Zinc-71m 1,000 Zinc-72 100 Gallium-65 1,000 Gallium-66 100 Gallium-67 1,000 Gallium-68 1,000 Gallium-70 1,000 Gallium-72 100 Gallium-73 1,000 Germanium-66 1,000 Germanium-67 1,000 Germanium-68 10 Germanium-69 1,000 Germanium-71 1,000 Germanium-75 1,000 Germanium-77 1,000 Germanium-78 1,000 Arsenic-69 1,000 Arsenic-70 1,000 Arsenic-71 100 Arsenic-72 100 Arsenic-73 100 Arsenic-74 100 Arsenic-76 100 Arsenic-77 100 Arsenic-78 1,000 Selenium-70 1,000 Selenium-73m 1,000 Selenium-73 100 Selenium-75 100 Selenium-79 100 Selenium-81m 1,000 Selenium-81 1,000 Selenium-83 1,000 Bromine-74m 1,000 Bromine-74 1,000 Bromine-75 1,000 Bromine-76 100 Bromine-77 1,000 Bromine-80m 1,000 Bromine-80 1,000 Bromine-82 100 Bromine-83 1,000 Bromine-84 1,000 Krypton-74 1,000 Krypton-76 1,000 Krypton-77 1,000 Krypton-79 1,000 Krypton-81 1,000 Krypton-83m 1,000 Krypton-85m 1,000 Krypton-85 1,000 Krypton-87 1,000 Krypton-88 1,000 Rubidium-79 1,000 Rubidium-81m 1,000 Rubidium-81 1,000 Rubidium-82m 1,000 Rubidium-83 100 Rubidium-84 100 Rubidium-86 100 Rubidium-87 100 Rubidium-88 1,000 Rubidium-89 1,000 Strontium-80 100 Strontium-81 1,000 Strontium-83 100 Strontium-85m 1,000 Strontium-85 100 Strontium-87m 1,000 Strontium-89 10 Strontium-90 0.1 Strontium-91 100 Strontium-92 100 Yttrium-86m 1,000 Yttrium-86 100 Yttrium-87 100 Yttrium-88 10 Yttrium-90m 1,000 Yttrium-90 10 Yttrium-91m 1,000 Yttrium-91 10 Yttrium-92 100 Yttrium-93 100 Yttrium-94 1,000 Yttrium-95 1,000 Zirconium-86 100 Zirconium-88 10 Zirconium-89 100 Zirconium-93 1 Zirconium-95 10 Zirconium-97 100 Niobium-88 1,000 Niobium-89m (66 min) 1,000 Niobium-89 (122 min) 1,000 Niobium-90 100 Niobium-93m 10 Niobium-94 1 Niobium-95m 100 Niobium-95 100 Niobium-96 100 Niobium-97 1,000 Niobium-98 1,000 Molybdenum-90 100 Molybdenum-93m 100 Molybdenum-93 10 Molybdenum-99 100 Molybdenum-101 1,000 Technetium-93m 1,000 Technetium-93 1,000 Technetium-94m 1,000 Technetium-94 1,000 Technetium-96m 1,000 Technetium-96 100 Technetium-97m 100 Technetium-97 1,000 Technetium-98 10 Technetium-99m 1,000 Technetium-99 100 Technetium-101 1,000 Technetium-104 1,000 Ruthenium-94 1,000 Ruthenium-97 1,000 Ruthenium-103 100 Ruthenium-105 1,000 Ruthenium-106 1 Rhodium-99m 1,000 Rhodium-99 100 Rhodium-100 100 Rhodium-101m 1,000 Rhodium-101 10 Rhodium-102m 10 Rhodium-102 10 Rhodium-103m 1,000 Rhodium-105 100 Rhodium-106m 1,000 Rhodium-107 1,000 Palladium-100 100 Palladium-101 1,000 Palladium-103 100 Palladium-107 10 Palladium-109 100 Silver-102 1,000 Silver-103 1,000 Silver-104m 1,000 Silver-104 1,000 Silver-105 100 Silver-106m 100 Silver-106 1,000 Silver-108m 1 Silver-11Om 10 Silver-111 100 Silver-112 100 Silver-115 1,000 Cadmium-104 1,000 Cadmium-107 1,000 Cadmium-109 1 Cadmium-113m 0.1 Cadmium-113 100 Cadmium-115m 10 Cadmium-115 100 Cadmium-117m 1,000 Cadmium-117 1,000 Indium-109 1,000 Indium-110 (69.1 min) 1,000 Indium-11O (4.9 h) 1,000 Indium-111 100 Indium-112 1,000 Indium-113m 1,000 Indium-114m 10 Indium-115m 1,000 Indium-115 100 Indium-116m 1,000 Indium-117m 1,000 Indium-117 1,000 Indium-119m 1,000 Tin-110 100 Tin-111 1,000 Tin-113 100 Tin-117m 100 Tin-119m 100 Tin-121m 100 Tin-121 1,000 Tin-123m 1,000 Tin-123 10 Tin-125 10 Tin-126 10 Tin-127 1,000 Tin-128 1,000 Antimony-115 1,000 Antimony-116m 1,000 Antimony-116 1,000 Antimony-117 1,000 Antimony-118m 1,000 Antimony-119 1,000 Antimony-120 (16 min) 1,000 Antimony-120 (5.76 d) 100 Antimony-122 100 Antimony-124m 1,000 Antimony-124 10 Antimony-125 100 Antimony-126m 1,000 Antimony-126 100 Antimony-127 100 Antimony-128 (10.4 min) 1,000 Antimony-128 (9.O1 h) 100 Antimony-129 100 Antimony-130 1,000 Antimony-131 1,000 Tellurium-116 1,000 Tellurium-121m 10 Tellurium-121 100 Tellurium-123m 10 Tellurium-123 100 Tellurium-125m 10 Tellurium-127m 10 Tellurium-127 1,000 Tellurium-129m 10 Tellurium-129 1,000 Tellurium-131m 10 Tellurium-131 100 Tellurium-132 10 Tellurium-133m 100 Tellurium-133 1,000 Tellurium-134 1,000 Iodine-120m 1,000 Iodine-120 100 Iodine-121 1,000 Iodine-123 100 Iodine-124 10 Iodine-125 1 Iodine-126 1 Iodine-128 1,000 Iodine-129 1 Iodine-130 10 Iodine-131 1 Iodine-132m 100 Iodine-132 100 Iodine-133 10 Iodine-134 1,000 Iodine-135 100 Xenon-120 1,000 Xenon-121 1,000 Xenon-122 1,000 Xenon-123 1,000 Xenon-125 1,000 Xenon-127 1,000 Xenon-129m 1,000 Xenon-131m 1,000 Xenon-133m 1,000 Xenon-133 1,000 Xenon-135m 1,000 Xenon-135 1,000 Xenon-138 1,000 Cesium-125 1,000 Cesium-127 1,000 Cesium-129 1,000 Cesium-130 1,000 Cesium-131 1,000 Cesium-132 100 Cesium-134m 1,000 Cesium-134 10 Cesium-135m 1,000 Cesium-135 100 Cesium-136 10 Cesium-137 10 Cesium-138 1,000 Barium-126 1,000 Barium-128 100 Barium-131m 1,000 Barium-131 100 Barium-133m 100 Barium-133 100 Barium-135m 100 Barium-139 1,000 Barium-140 100 Barium-141 1,000 Barium-142 1,000 Lanthanum-131 1,000 Lanthanum-132 100 Lanthanum-135 1,000 Lanthanum-137 10 Lanthanum-138 100 Lanthanum-140 100 Lanthanum-141 100 Lanthanum-142 1,000 Lanthanum-143 1,000 Cerium-134 100 Cerium-135 100 Cerium-137m 100 Cerium-137 1,000 Cerium-139 100 Cerium-141 100 Cerium-143 100 Cerium-144 1 Praseodymium-136 1,000 Praseodymium-137 1,000 Praseodymium-138m 1,000 Praseodymium-139 1,000 Praseodymium-142m 1,000 Praseodymium-142 100 Praseodymium-143 100 Praseodymium-144 1,000 Praseodymium-145 100 Praseodymium-147 1,000 Neodymium-136 1,000 Neodymium-138 100 Neodymium-139m 1,000 Neodymium-139 1,000 Neodymium-141 1,000 Neodymium-147 100 Neodymium-149 1,000 Neodymium-151 1,000 Promethium-141 1,000 Promethium-143 100 Promethium-144 10 Promethium-145 10 Promethium-146 1 Promethium-147 10 Promethium-148m 10 Promethium-148 10 Promethium-149 100 Promethium-150 1,000 Promethium-151 100 Samarium-141m 1,000 Samarium-141 1,000 Samarium-142 1,000 Samarium-145 100 Samarium-146 1 Samarium-147 100 Samarium-151 10 Samarium-153 100 Samarium-155 1,000 Samarium-156 1,000 Europium-145 100 Europium-146 100 Europium-147 100 Europium-148 10 Europium-149 100 Europium-150 (12.62 h) 100 Europium-150 (34.2 y) 1 Europium-152m 100 Europium-152 1 Europium-154 1 Europium-155 10 Europium-156 100 Europium-157 100 Europium-158 1,000 Gadolinium-145 1,000 Gadolinium-146 10 Gadolinium-147 100 Gadolinium-148 0.001 Gadolinium-149 100 Gadolinium-151 10 Gadolinium-152 100 Gadolinium-153 10 Gadolinium-159 100 Terbium-147 1,000 Terbium-149 100 Terbium-150 1,000 Terbium-151 100 Terbium-153 1,000 Terbium-154 100 Terbium-155 1,000 Terbium-156m (5.O h) 1,000 Terbium-156m (24.4 h) 1,000 Terbium-156 100 Terbium-157 10 Terbium-158 1 Terbium-160 10 Terbium-161 100 Dysprosium-155 1,000 Dysprosium-157 1,000 Dysprosium-159 100 Dysprosium-165 1,000 Dysprosium-166 100 Holmium-155 1,000 Holmium-157 1,000 Holmium-159 1,000 Holmium-161 1,000 Holmium-162m 1,000 Holmium-162 1,000 Holmium-164m 1,000 Holmium-164 1,000 Holmium-166m 1 Holmium-166 100 Holmium-167 1,000 Erbium-161 1,000 Erbium-165 1,000 Erbium-169 100 Erbium-171 100 Erbium-172 100 Thulium-162 1,000 Thulium-166 100 Thulium-167 100 Thulium-170 10 Thulium-171 10 Thulium-172 100 Thulium-173 100 Thulium-175 1,000 Ytterbium-162 1,000 Ytterbium-166 100 Ytterbium-167 1,000 Ytterbium-169 100 Ytterbium-175 100 Ytterbium-177 1,000 Ytterbium-178 1,000 Lutetium-169 100 Lutetium-170 100 Lutetium-171 100 Lutetium-172 100 Lutetium-173 10 Lutetium-174m 10 Lutetium-174 10 Lutetium-176m 1,000 Lutetium-176 100 Lutetium-177m 10 Lutetium-177 100 Lutetium-178m 1,000 Lutetium-178 1,000 Lutetium-179 1,000 Hafnium-170 100 Hafnium-172 1 Hafnium-173 1,000 Hafnium-175 100 Hafnium-177m 1,000 Hafnium-178m 0.1 Hafnium-179m 10 Hafnium-180m 1,000 Hafnium-181 10 Hafnium-182m 1,000 Hafnium-182 0.1 Hafnium-183 1,000 Hafnium-184 100 Tantalum-172 1,000 Tantalum-173 1,000 Tantalum-174 1,000 Tantalum-175 1,000 Tantalum-176 100 Tantalum-177 1,000 Tantalum-178 1,000 Tantalum-179 100 Tantalum-180m 1,000 Tantalum-180 100 Tantalum-182m 1,000 Tantalum-182 10 Tantalum-183 100 Tantalum-184 100 Tantalum-185 1,000 Tantalum-186 1,000 Tungsten-176 1,000 Tungsten-177 1,000 Tungsten-178 1,000 Tungsten-179 1,000 Tungsten-181 1,000 Tungsten-185 100 Tungsten-187 100 Tungsten-188 10 Rhenium-177 1,000 Rhenium-178 1,000 Rhenium-181 1,000 Rhenium-182 (12.7 h) 1,000 Rhenium-182 (64.O h) 100 Rhenium-184m 10 Rhenium-184 100 Rhenium-186m 10 Rhenium-186 100 Rhenium-187 1,000 Rhenium-188m 1,000 Rhenium-188 100 Rhenium-189 100 Osmium-180 1,000 Osmium-181 1,000 Osmium-182 100 Osmium-185 100 Osmium-189m 1,000 Osmium-191m 1,000 Osmium-191 100 Osmium-193 100 Osmium-194 1 Iridium-182 1,000 Iridium-184 1,000 Iridium-185 1,000 Iridium-186 100 Iridium-187 1,000 Iridium-188 100 Iridium-189 100 Iridium-190m 1,000 Iridium-190 100 Iridium-192m (1.4 min) 10 Iridium-192 (73.8 d) 1 Iridium-194m 10 Iridium-194 100 Iridium-195m 1,000 Iridium-195 1,000 Platinum-186 1,000 Platinum-188 100 Platinum-189 1,000 Platinum-191 100 Platinum-193m 100 Platinum-193 1,000 Platinum-195m 100 Platinum-197m 1,000 Platinum-197 100 Platinum-199 1,000 Platinum-200 100 Gold-193 1,000 Gold-194 100 Gold-195 10 Gold-198m 100 Gold-198 100 Gold-199 100 Gold-200m 100 Gold-200 1,000 Gold-201 1,000 Mercury-193m 100 Mercury-193 1,000 Mercury-194 1 Mercury-195m 100 Mercury-195 1,000 Mercury-197m 100 Mercury-197 1,000 Mercury-199m 1,000 Mercury-203 100 Thallium-194m 1,000 Thallium-194 1,000 Thallium-195 1,000 Thallium-197 1,000 Thallium-198m 1,000 Thallium-198 1,000 Thallium-199 1,000 Thallium-201 1,000 Thallium-200 1,000 Thallium-202 100 Thallium-204 100 Lead-195m 1,000 Lead-198 1,000 Lead-199 1,000 Lead-200 100 Lead-201 1,000 Lead-202m 1,000 Lead-202 10 Lead-203 1,000 Lead-205 100 Lead-209 1,000 Lead-210 0.01 Lead-211 100 Lead-212 1 Lead-214 100 Bismuth-200 1,000 Bismuth-201 1,000 Bismuth-202 1,000 Bismuth-203 100 Bismuth-205 100 Bismuth-206 100 Bismuth-207 10 Bismuth-210m 0.1 Bismuth-210 1 Bismuth-212 10 Bismuth-213 10 Bismuth-214 100 Polonium-203 1,000 Polonium-205 1,000 Polonium-207 1,000 Polonium-210 0.1 Astatine-207 100 Astatine-211 10 Radon-220 1 Radon-222 1 Francium-222 100 Francium-223 100 Radium-223 0.1 Radium-224 0.1 Radium-225 0.1 Radium-226 0.1 Radium-227 1,000 Radium-228 0.1 Actinium-224 1 Actinium-225 0.01 Actinium-226 0.1 Actinium-227 0.001 Actinium-228 1 Thorium-226 10 Thorium-227 0.01 Thorium-228 0.001 Thorium-229 0.001 Thorium-230 0.001 Thorium-231 100 Thorium-232 100 Thorium-234 10 Thorium-natural 100 Protactinium-227 10 Protactinium-228 1 Protactinium-230 0.1 Protactinium-231 0.001 Protactinium-232 1 Protactinium-233 100 Protactinium-234 100 Uranium-230 0.01 Uranium-231 100 Uranium-232 0.001 Uranium-233 0.001 Uranium-234 0.001 Uranium-235 0.001 Uranium-236 0.001 Uranium-237 100 Uranium-238 100 Uranium-239 1,000 Uranium-240 100 Uranium-natural 100 Neptunium-232 100 Neptunium-233 1,000 Neptunium-234 100 Neptunium-235 100 Neptunium-236 (1.15E+5 y) 0.001 Neptunium-236 (22.5 h) 1 Neptunium-237 0.001 Neptunium-238 10 Neptunium-239 100 Neptunium-240 1,000 Plutonium-234 10 Plutonium-235 1,000 Plutonium-236 0.001 Plutonium-237 100 Plutonium-238 0.001 Plutonium-239 0.001 Plutonium-240 0.001 Plutonium-241 0.01 Plutonium-242 0.001 Plutonium-243 1,000 Plutonium-244 0.001 Plutonium-245 100 Americium-237 1,000 Americium-238 100 Americium-239 1,000 Americium-240 100 Americium-241 0.001 Americium-242m 0.001 Americium-242 10 Americium-243 0.001 Americium-244m 100 Americium-244 10 Americium-245 1,000 Americium-246m 1,000 Americium-246 1,000 Curium-238 100 Curium-240 0.1 Curium-241 1 Curium-242 0.01 Curium-243 0.001 Curium-244 0.001 Curium-245 0.001 Curium-246 0.001 Curium-247 0.001 Curium-248 0.001 Curium-249 1,000 Berkelium-245 100 Berkelium-246 100 Berkelium-247 0.001 Berkelium-249 0.1 Berkelium-250 10 Californium-244 100 Californium-246 1 Californium-248 0.01 Californium-249 0.001 Californium-250 0.001 Californium-251 0.001 Californium-252 0.001 Californium-253 0.1 Californium-254 0.001 Einsteinium-250 100 Einsteinium-251 100 Einsteinium-253 0.1 Einsteinium-254m 1 Einsteinium-254 0.01 Fermium-252 1 Fermium-253 1 Fermium-254 10 Fermium-255 1 Fermium-257 0.01 Mendelevium-257 10 Mendelevium-258 0.01 Any alpha-emitting radionuclide not listed above or mixtures of alpha emitters of unknown composition 0.001 Any radionuclide other than alphaemitting radionuclides not listed above, or mixtures of beta emitters of unknown composition 0.01 NOTE: For purposes of Subsections 6. 27.e., 6.30.a.1., and 6.53.a. where there is involved a combination of radionuclides in known amounts, the limit for the combination shall be derived as follows: determine, for each radionuclide in the combination, the ratio between the quantity present in the combination and the limit otherwise established for the specific radionuclide when not in combination. The sum of such ratios for all radionuclides in the combination may not exceed one"1" -- that is, unity. a The quantities listed above were derived by taking one tenth (1/10) of the most restrictive ALI listed in Table I, Columns 1 and 2, of Table 64-23 F, rounding to the nearest factor of ten (10), and constraining the values listed between thirty seven (37) Bq and thirty seven (37) MBq (one one-thousand [0.001] and one thousand [1,000] Ci). Values of three and seven one-hundredths (3.7) MBq (one hundred [100] Ci) have been assigned for radionuclides having a radioactive half-life in excess of E+9 years, except rhenium, thirty seven (37) MBq (one thousand [1,000] Ci), to take into account their low specific activity. b/ To convert Ci to kBq, multiply the Ci value by thirty seven (37).
TABLE 64-23 H
REQUIREMENTS FOR TRANSFER OF LOW-LEVEL RADIOACTIVE WASTE
FOR DISPOSAL AT LAND DISPOSAL FACILITIES AND MANIFESTS
Section I. - Manifest.
The shipment manifest shall contain the name, address, and telephone number of the person generating the waste. The manifest shall also include the name, address, and telephone number or the name and the environmental protection agency hazardous waste identification number of the person transporting the waste to the land disposal facility. The manifest shall also indicate: a physical description of the waste, the volume, radionuclide identity and quantity, the total radioactivity, and the principal chemical form. The solidification agent shall be specified. Waste containing more than one tenth (0.1) percent chelating agents by weight shall be identified and the weight percentage of the chelating agent estimated. Wastes classified as Class A, Class B, or Class C in Section I of Table 64-23 I shall be clearly identified as such in the manifest. The total quantity of the radionuclides Hydrogen-3, Carbon-14, Technetium-99, and Iodine-129 shall be shown. The manifest required by this paragraph may be shipping papers used to meet the Department of Transportation or the Environmental Protection Agency regulations or requirements of the receiver, provided all the required information is included. Copies of manifests required by this section may be legible carbon copies or legible photocopies.
Section II. - Certification.
The waste generator shall include in the shipment manifest a certification that the transported materials are properly classified, described, packaged, marked, and labeled and are in proper condition for transportation according to the applicable regulations of the department of transportation and the agency. An authorized representative of the waste generator shall sign and date the manifest.
Section III. - Control and Tracking.
a. Any radioactive waste generator who transfers radioactive waste to a land disposal facility or a registered waste collector shall comply with the requirements in (a)(1) through (8). Any radioactive waste generator who transfers waste to a registered waste processor who treats or repackages waste shall comply with the requirements of (a)(4) through (8). A registrant shall:
-
Prepare all wastes so that the waste is classified according to Section I of Table 64-23 I meets the waste characteristics requirements in Section II of Table 64-23 I;
-
Label each package of waste to identify whether it is class a waste, Class B waste, or Class C waste, in accordance with Section I of Table 64-23 I;
-
Conduct a quality control program to ensure compliance with Section I and II of Table 64-23 K; the program shall include management evaluation of audits;
-
Prepare shipping manifests to meet the requirements of Section I and II;
-
Forward a copy of the manifest to the intended recipient, at the time of shipment, or deliver to a collector at the time the waste is collected, obtaining acknowledgment of receipt in the form of a signed copy of the manifest or equivalent documentation from the collector;
-
Include one copy of the manifest with the shipment;
-
Retain a copy of the manifest and documentation of acknowledgment of receipt as the record of transfer of registered material as required by Section 11.26. of this rule; and 8. For any shipments or any portion of a shipment for which acknowledgment of receipt has not been received within the times set forth in this section, conduct an investigation in accordance with Section III.(e).
b. Any waste collector registrant who handles only prepackaged waste shall:
-
Acknowledge receipt of the waste from the generator within one (1) week of receipt by returning a signed copy of the manifest or equivalent documentation;
-
Prepare a new manifest to reflect consolidated shipments; the new manifest shall serve as a listing or index for the detailed generator manifests. Copies of the generator manifests shall be a part of the new manifest. The waste collector may prepare a new manifest without attaching the generator manifests, provided the new manifest contains for each package the information specified in Section I. The collector registrant shall certify that nothing has been done to the waste that would invalidate the generator's certification;
-
Forward a copy of the new manifest to the land disposal facility operator at the time of shipment;
-
Include the new manifest with the shipment to the disposal site;
-
Retain a copy of the manifest and documentation of acknowledgment of receipt as the record of transfer of registered material as required by Subsection 11.26. of this rule, and retain information from generator manifest until the registration is terminated and disposition is authorized by the agency; and 6. For any shipments or any portion of a shipment for which acknowledgment of receipt is not received within the times set forth in this section, conduct an investigation in accordance with Section III.(e).
c. Any registered waste processor who treats or repackages wastes shall:
-
Acknowledge receipt of the waste from the generator within one (1) week of receipt by returning a signed copy of the manifest or equivalent documentation;
-
Prepare a new manifest that meets the requirements of Section I and II. Preparation of the new manifest reflects that the processor is responsible for the waste;
-
Prepare all wastes so that the waste is classified according to Section I of Table 64-23 I and meets the waste characteristics requirements in Section II of Table 64-23 I;
-
Label each package of waste to identify whether it is Class A waste, Class B waste, or Class C waste, in accordance with Section I and III of Table 64-23 I;
-
Conduct a quality control program to ensure compliance with Section I and II of Table 64-23 I.. The program shall include management evaluation of audits;
-
Forward a copy of the new manifest to the disposal site operator or waste collector at the time of shipment, or deliver to a collector at the time the waste is collected, obtaining acknowledgment of receipt in the form of a signed copy of the manifest or equivalent documentation by the collector;
-
Include the new manifest with the shipment;
-
Retain copies of original manifests and new manifests and documentation of acknowledgment of receipt as the record of transfer of registered material required by Subsection 11.26. of this rule; and 9. For any shipment or portion of a shipment for which acknowledgment is not received within the times set forth in this section, conduct an investigation in accordance with Section III.(e).
d. The land disposal facility operator shall:
-
Acknowledge receipt of the waste within one (1) week of receipt by returning a signed copy of the manifest or equivalent documentation to the shipper. The shipper to be notified is the registrant who last possessed the waste and transferred the waste to the operator. The returned copy of the manifest or equivalent documentation shall indicate any discrepancies between materials listed on the manifest and materials received;
-
Maintain copies of all completed manifests or equivalent documentation until the agency authorizes their disposition; and 3. Notify the shipper, that is, the generator, the collector, or processor, and the agency when any shipment or portion of a shipment has not arrived within sixty (60) days after the advance manifest was received.
e. Any shipment or portion of a shipment for which acknowledgment is not received within the times set forth in this section shall:
- Be investigated by the shipper if the shipper has not received notification or receipt within twenty (20) days after transfer; and 2. Be traced and reported to whom. The investigation shall include tracing the shipment and filing a report with the agency. Each registrant who conducts a trace investigation shall file a written report with the agency within two (2) weeks of completion of the investigation.
TABLE 64-23 I
CLASSIFICATION AND CHARACTERISTICS OF LOW-LEVEL
RADIOACTIVE WASTE
Section i. - Classification of Radioactive Waste for Land Disposal.
a. Considerations. Determination of the classification of radioactive waste involves two considerations. First, consideration must be given to the concentration of long-lived radionuclides (and their shorter-lived precursors) whose potential hazard will persist long after such precautions as institutional controls, improved waste form, and deeper disposal have ceased to be effective. These precautions delay the time when long-lived radionuclides could cause exposures. In addition, the magnitude of the potential dose is limited by the concentration and availability of the radionuclide at the time of exposure. Second, consideration must be given to the concentration of shorter-lived radionuclides for which requirements on institutional controls, waste form, and disposal methods are effective.
b. Classes of waste.
-
Class A waste is waste that is usually segregated from other waste classes at the disposal site. The physical form and characteristics of class a waste must meet the minimum requirements set forth in Section II.(a). If Class a waste also meets the stability requirements set forth in Section II.(b), it is not necessary to segregate the waste for disposal.
-
Class B waste is waste that must meet more rigorous requirements on waste form to ensure stability after disposal. The physical form and characteristics of Class B waste must meet both the minimum and stability requirements set forth in Section II.
-
Class C waste is waste that not only must meet more rigorous requirements on waste form to ensure stability but also requires additional measures at the disposal facility to protect against inadvertent intrusion. The physical form and characteristics of Class C waste must meet both the minimum and stability requirements set forth in Section II.
c. Classification determined by long-lived radionuclides. If the radioactive waste contains only radionuclides listed in Table 64-23 J, classification shall be determined as follows:
-
If the concentration does not exceed one tenth (0.1) times the value in Table 64-23 J, the waste is Class A.
-
If the concentration exceeds one tenth (0.1) times the value in Table 64-23 J, but does not exceed the value in Table 64-23 J, the waste is Class C.
-
If the concentration exceeds the value in Table 64-23 J, the waste is not generally acceptable for land disposal.
-
For wastes containing mixtures of radionuclides listed in Table J, the total concentration shall be determined by the sum of fractions rule described in Section I.(g).
TABLE 64-23 J
Concentration Rationuclide Curie/CubicMeter Nano curie/Grab C-14 C-14 in activated metal No-59 in activated metal Nb-94 in activated metal
0.2 To-99 I-129
0.08 Alpha emitting transuranic radionuclides with half-life greater than five years Pu-241 3,500 Cm-242 20,000 Ra-226 a To convert the Ci/me values to gigabecquerel (GBq) per cubic meter, multiply the Ci/me value by thirty seven (37). b To convert the nCi/g values to becquerel (Bq) per gram, multiply the nCi/g value by thirty seven (37).
d. Classification determined by short-lived radionuclides. If the waste does not contain any of the radionuclides listed in Table 64-23 J, classification shall be determined based on the concentrations shown in Table 64-23 K. However, as specified in Section I.(f), if radioactive waste does not contain any nuclides listed in either Table 64-23 J or K, it is Class A.
-
If the concentration does not exceed the value in Column 1, the waste is Class A.
-
If the concentration exceeds the value in column 1 but does not exceed the value in Column 2, the waste is Class B.
-
If the concentration exceeds the value in Column 2 but does not exceed the value in Column 3, the waste is Class C.
-
If the concentration exceeds the value in Column 3, the waste is not generally acceptable for near-surface disposal.
-
For wastes containing mixtures of the radionuclides listed in Table M, the total concentration shall be determined by the sum of fractions rule described in Section I.(g).
TABLE 64-23 K
Radionuclide Concentration Curie/Cubic Metera Column 1 Column 2 Column 3 Total of all radionuclides with less than 5-year half-life 700 * * H-3 40 * * Co-60 700 * * No-63 3.5 70 700 No-63 in activated metal 35 700 7000 Sr-90 0.04 150 7000 Cs-137 1 44 4600 aAGENCY NOTE: To convert the Ci/meter3 value to gigabecquerel (GBq) per cubic meter, multiply the Ci/meter3 value by thirty seven (37). There are no limits established for these radionuclides in class b or c wastes. Practical considerations such as the effects of external radiation and internal heat generation on transportation, handling, and disposal will limit the concentrations for these wastes. These wastes shall be class b unless the concentrations of other radionuclides in table 64-23 K determine the waste to be class c independent of these radionuclides.
e. Classification determined by both long- and short-lived radionuclides. If the radioactive waste contains a mixture of radionuclides, some of which are listed in table 64-23 J and some of which are listed in table 64-23 K, classification shall be determined as follows:
-
If the concentration of a radionuclide listed in table 64-23 J is less than one tenth (0.1) times the value listed in table 64-23 J, the class shall be that determined by the concentration of radionuclides listed in table 64-23 K.
-
If the concentration of a radionuclide listed in table 64-23 J exceeds 0.1 times the value listed in table l, but does not exceed the value in table 64-23 J, the waste shall be class c, provided the concentration of radionuclides listed in table 64-23 K does not exceed the value shown in column 3 of table 64-23 K.
f. Classification of wastes with radionuclides other than those listed in tables 64-23 J and K. If the waste does not contain any radionuclides listed in either table 64-23 J or K, it is class a..
g. The sum of the fractions rule for mixtures of radionuclides. For determining classification for waste that contains a mixture of radionuclides, it is necessary to determine the sum of fractions by dividing each radionuclide's concentration by the appropriate limit and adding the resulting values. The appropriate limits must all be taken from the same column of the same table. The sum of the fractions for the column must be less than one (1.0) if the waste class is to be determined by that column. Example: A waste contains Sr-90 in a concentration of one and eighty five one-hundredths (1.85) TBq/me (fifty [50] Ci/me) and Cs-137 in a concentration of eight hundred fourteen (814) GBq/me (twenty two (22) Ci/me). Since the concentrations both exceed the values in Column 1, Table M, they must be compared to Column 2 values. For Sr-90 fraction, fifty one hundredths (50/150) = thirty three one-hundredths (0.33)., for Cs-137 fraction, twenty two forty four one-hundredths (22/44) = fife tenths (0.5); the sum of the fractions = eighty three one-hundredths (0.83). Since the sum is less than one (1.0), the waste is Class B.
h. Determination of concentrations in wastes. The concentration of a radionuclide may be determined by indirect methods such as use of scaling factors which relate the inferred concentration of one radionuclide to another that is measured, or radionuclide material accountability, if there is reasonable assurance that the indirect methods can be correlated with actual measurements. The concentration of a radionuclide may be averaged over the volume of the waste, or weight of the waste if the units are expressed as becquerel (nanocurie) per gram.
Section ii. - Radioactive Waste Characteristics.
a. The following are minimum requirements for all classes of waste and are intended to facilitate handling and provide protection of health and safety of personnel at the disposal site.
-
Wastes shall be packaged in conformance with the conditions of the registration issued to the site operator to which the waste will be shipped. Where the conditions of the site registration are more restrictive than the provisions of section 6., the site registration conditions shall govern.
-
Wastes shall not be packaged for disposal in cardboard or fiberboard boxes.
-
Liquid waste shall be packaged in sufficient absorbent material to absorb twice the volume of the liquid.
-
Solid waste containing liquid shall contain as little free-standing and non-corrosive liquid as is reasonably achievable, but in no case shall the liquid exceed one (1) percent of the volume.
-
Waste shall not be readily capable of detonation or of explosive decomposition or reaction at normal pressures and temperatures, or of explosive reaction with water.
-
Waste shall not contain, or be capable of generating, quantities of toxic gases, vapors, or fumes harmful to persons transporting, handling, or disposing of the waste. This does not apply to radioactive gaseous waste packaged in accordance with Section II.(a)(8).
-
Waste must not be pyrophoric. Pyrophoric materials contained in wastes shall be treated, prepared, and packaged to be nonflammable.c 8. Wastes in a gaseous form shall be packaged at an absolute pressure that does not exceed 1.5 atmospheres at twenty (20)C. Total activity shall not exceed three and seven tenths (3.7) TBq (one hundred [100] Ci) per container.
-
Wastes containing hazardous, biological, pathogenic, or infectious material shall be treated to reduce to the maximum extent practicable the potential hazard from the non-radiological materials.
b. The following requirements are intended to provide stability of the waste. Stability is intended to ensure that the waste does not degrade and affect overall stability of the site through slumping, collapse, or other failure of the disposal unit and thereby lead to water infiltration. Stability is also a factor in limiting exposure to an inadvertent intruder, since it provides a recognizable and nondispersible waste.
-
Waste shall have structural stability. A structurally stable waste form will generally maintain its physical dimensions and its form, under the expected disposal conditions such as weight of overburden and compaction equipment, the presence of moisture, and microbial activity, and internal factors such as radiation effects and chemical changes. Structural stability can be provided by the waste form itself, processing the waste to a stable form, or placing the waste in a disposal container or structure that provides stability after disposal.
-
Notwithstanding the provisions in Section II.(a)(3) and (4), liquid wastes, or wastes containing liquid, shall be converted into a form that contains as little free-standing and non-corrosive liquid as is reasonably achievable, but in no case shall the liquid exceed one (1) percent of the volume of the waste when the waste is in a disposal container designed to ensure stability, or five tenths (0.5) percent of the volume of the waste for waste processed to a stable form.
-
Void spaces within the waste and between the waste and its package shall be reduced to the extent practicable.
Section iii. - Labeling.
Each package of waste shall be clearly labeled to identify whether it is Class A, Class B, or Class C waste, in accordance with Section I.
TABLE 64-23 L
QUANTITIES FOR USE WITH DECOMMISSIONING
Material Microcuriea Material Microcuriea Americium-241 0.01 Antimony-122 100 Antimony-124 10 Antimony-125 10 Arsenic-73 100 Arsenic-74 10 Arsenic-76 10 Arsenic-77 100 Barium-131 10 Barium-133 10 Barium-140 10 Bismuth-210 1 Bromine-82 10 Cadmium-109 10 Cadmium-115m 10 Cadmium-115 100 Calcium-45 10 Calcium-47 10 Carbon-14 100 Cerium-141 100 Cerium-143 100 Cerium-144 1 Cesium-131 1,000 Cesium-134m 100 Cesium-134 1 Cesium-135 10 Cesium-136 10 Cesium-137 10 Chlorine-36 10 Chlorine-38 10 Chromium-51 1,000 Cobalt-58m 10 Cobalt-58 10 Cobalt-60 1 Copper-64 100 Dysprosium-165 10 Dysprosium-166 100 Erbium-169 100 Erbium-171 100 Europium-152 (9.2 h) 100 Europium-152 (13 yr) 1 Europium-154 1 Europium-155 10 Florine-18 1,000 Gadolinium-153 10 Gadolinium-159 100 Gallium-72 10 Germanium-71 0 Hafnium-181 10 Holmium-166 100 Hydrogen-3 1,000 Indium-113m 100 Indium-114m 10 Indium-115m 100 Indium-115 10 Iodine-125 1 Iodine-126 1 Iodine-129 0.1 Iodine-131 1 Iodine-132 10 Iodine-133 1 Iodine-134 10 Iodine-135 10 Iridium-192 10 Iridium-194 100 Iron-55 100 Iron-59 10 Krypton-85 100 Krypton-87 10 Lanthanum-140 10 Lutetium-177 100 Manganese-52 10 TABLE 64-23 L QUANTITIES FOR USE WITH DECOMMISSIONING Material Microcuriea Material Microcuriea Manganese-54 10 Manganese-56 10 Mercury-197m 100 Mercury-197 100 Mercury-203 10 Molybdenum-99 100 Neodymium-147 100 Neodymium-149 100 Nickel-59 100 Nickel-63 10 Nickel-65 100 Niobium-93m 10 Niobium-95 10 Niobium-97 10 Osmium-185 10 Osmium-191m 100 Osmium-191 100 Osmium-193 100 Palladium-103 100 Palladium-109 100 Phosphorus-32 10 Platinum-191 100 Platinum-193m 100 Platinum-193 100 Platinum-197m 100 Platinum-197 100 Plutonium-239 0.01 Polonium-210 0.1 Potassium-42 10 Praseodymium-142 100 Praseodymium-143 100 Promethium-147 10 Promethium-149 10 Radium-226 0.01 Rhenium-186 100 Rhenium-188 100 Rhodium-103m 100 Rhodium-105 100 Rubidium-86 10 Rubidium-87 10 Ruthenium-97 100 Ruthenium-103 10 Ruthenium-105 10 Ruthenium-106 1 Samarium-151 10 Samarium-153 100 Scandium-46 10 Scandium-47 100 Scandium-48 10 Selenium-75 10 Silicon-31 100 Silver-105 10 Silver-11Om 1 Silver-111 100 Sodium-22 1 Sodium-24 10 Strontium-85 10 Strontium-89 1 Strontium-90 0.1 Strontium-91 10 Strontium-92 10 Sulfur -35 100 Tantalum-182 10 Technetium-96 10 Technetium-97m 100 Technetium-97 100 Technetium-99m 100 Technetium-99 10 Tellurium-125m 10 Tellurium-127m 10 Tellurium-127 100 Tellurium-129m 10 Tellurium-129 100 Tellurium-131m 10 Tellurium-132 10 Terbium-160 10 TABLE 64-23 L QUANTITIES FOR USE WITH DECOMMISSIONING Material Microcuriea Material Microcuriea Thallium-200 100 Yttrium-90 10 Thallium-201 100 Yttrium-92 100 Thallium-202 100 Yttrium-93 100 Thallium-204 10 Zinc-65 10 Thorium (natural)aa 100 Zinc-69m 100 Thulium-170 10 Zinc-69 1,000 Thulium-171 10 Zirconium-93 10 Tin-113 10 Zirconium-95 10 Tin-125 10 Zirconium-97 10 Tungsten-181 10 Tungsten-185 10 Any alpha emitting Tungsten-187 100 radionuclide not listed Uranium (natural)aaa 100 above or mixtures of Uranium-233 0.01 alpha emitters of Uranium-234 0.01 unknown composition 0.01 Uranium-235 0.01 Vanadium-48 10 Any radionuclide other Xenon-131m 1,000 than alpha emitting Xenon-133 100 radionuclides, not Xenon-135 100 listed above or mixtures Ytterbium-175 100 of beta emitters of unknown composition 0.1 NOTE: Where there is involved a combination of isotopes in known amounts, the limit for the combination should be derived as follows: Determine, for each isotope in the combination, the ratio between the quantity present in the combination and the limit otherwise established for the specific isotope when not in combination. The sum of such ratios for all the isotopes in the combination may not exceed one (1) -- that is, unity.]
TABLE 64-23 M
Time-Temperature Chart Thermometer Reading (Degrees)
Minimum Developing Time (Minutes) oC oF
26.7
26.1
25.6
25.0
24.4
23.9
23.3
22.8
22.2
21.7
21.1
20.6
20.0
19.4
18.9
18.3
17.8
17.2
16.7
16.1
15.6 TABLE 64-23 N
Developer Temperature Minimum Immersion Timea/ oC oF Seconds
35.5
34.5
33.5
31.5
30.5
29.5 a/ Immersion time only, no crossover time included.
TABLE 64-23 O
Design Operating Range Measured Potential (kVp)
Half-Value Layer In mm Aluminum Dental Intra-Oral Manufactured Before Aug. 1, 1974 and On or After Dec. 1, 1980 All Other Diagnostic X-Ray Systems Below 51 N/A
0.3 N/A
0.4
0.5 51 to 70
1.2
1.3 Above 70
2.1
2.1
2.3
2.3
2.5
2.5
2.7
2.7
3.0
3.0
3.2
3.2
3.8
3.8
4.1
4.1 TABLE 64-23 P
DETERMINATION OF COMPETENCE
The following are areas in which the agency considers it important that an individual have expertise for the competent operation of x-ray equipment:
a. Familiarization with equipment 1. Identification of controls 2. Function of each control 3. How to use a technique chart b. Radiation Protection 1. Collimation 2. Filtration 3. Gonad shielding and other patient protection devices if used 4. Restriction of x-ray tube radiation to the image receptor 5. Personnel protection 6. Grids c. Film Processing 1. Film speed as related to patient exposure 2. Film processing parameters 3. Quality assurance program d. Emergency Procedures 1. Termination of exposure in event of automatic timing device failure e. Proper Use of Personnel Dosimetry, if Required f. Understanding Units of Radiation TABLE 64-23 Q INFORMATION ON RADIATION SHIELDING REQUIRED FOR PLAN REVIEWS In order for the agency to provide an evaluation, technical advice, and official approval on shielding requirements for a radiation installation, the following information must be submitted.
a. The plans showing, as a minimum, the following:
-
The normal location of the system's radiation port; the port's travel and traverse limits; general direction or directions of the useful beam; locations of any windows and doors or other openings; the location of the operator's booth; and the location of the control panel;
-
The structural composition and thickness or lead equivalent of all walls, doors, partitions, floor, and ceiling of the room or rooms concerned;
-
The dimensions of the room or rooms concerned;
-
The type of occupancy of all adjacent areas inclusive of space above and below the room or rooms concerned. If there is an exterior wall, show distance to the closest areas where it is likely that individuals may be present;
-
The make and model of the equipment, the maximum technique factors, and the energy waveform (single phase, three phase, etc.);
-
The type of examination or examinations or treatment or treatments which will be performed with the equipment.
b. Information on the anticipated workload of the system or systems in mA-minutes per week.
c. A report showing all basic assumptions used in the development of the shielding specifications.
TABLE 64-23 R
DESIGN REQUIREMENTS FOR AN OPERATOR'S BOOTH
a. Space Requirements:
-
The operator shall be allotted not less than seven tenths (0.70) m5 (seven and five tenths [7.5] square feet) of unobstructed floor space in the booth;
-
The operator's booth may be any geometric configuration with no dimension of less than six tenths (0.6) m (two [2] feet);
-
The space shall be allotted excluding any encumbrance by the x-ray control panel, such as overhang, cables, or other similar encroachments;
-
The booth shall be located or constructed such that unattenuated direct scatter radiation originating on the examination table or at the wall-mounted image receptor will not reach the operator's position in the booth.
b. Structural Requirements:
-
The booth walls shall be permanently fixed barriers of at least two (2) m (seven [7] feet) high;
-
When a door or movable panel is used as an integral part of the booth structure, it must have an interlock which will prevent an exposure when the door or panel is not closed;
-
Shielding shall be provided to meet the requirements of Section 6. of this rule.
c. Radiation Exposure Control Placement:
- The radiation exposure control for the system shall be fixed within the booth and:
A. Shall be at least one (1.0) m (forty [40] inches) from any point subject to direct scatter, leakage or primary beam radiation;
B. Shall allow the operator to use the majority of the available viewing windows.
d. Viewing System Requirements:
- Each booth shall have at least one viewing device which will:
A. Be so placed that the operator can view the patient during any exposure; and B. Be so placed that the operator can have full view of any occupant of the room and should be so placed that the operator can view any entry into the room. If any door which allows access to the room cannot be seen from the booth, then outside that door there shall be an "x-ray on" warning sign that will be lighted anytime the rotor of the x-ray tube is activated. Alternatively, an interlock shall be present such that exposures are prevented unless the door is closed.
- When the viewing system is a window, the following requirements also apply:
A. The window shall have a viewing area of at least 0.09 m5 (1 square foot);
B. Regardless of size or shape, at least nine one-hundredths (0.09) m5 (one (1) square foot) of the window area must be centered no less than six tenths (0.6) m (two [2] feet) from the open edge of the booth and no less than one and five tenths (1.5) m (five (5.0) feet) from the floor;
C. The window shall have at least the same lead equivalence as that required in the booth's wall in which it is mounted.
-
When the viewing system is by mirrors, the mirror or mirrors shall be so located as to accomplish the general requirements of Subsection 6.5.
-
When the viewing system is by electronic means:
A. The camera shall be so located as to accomplish the general requirements of subsection 6.5.; and B. There shall be an alternate viewing system as a backup for the primary system.
TABLE 64-23 S
EXEMPTIONS FROM SHIELDING
FOR CERTAIN FLUOROSCOPIC PROCEDURES
a. Angiograms b. Arthrograms c. Biliary drainage procedures d. Fluoroscopic biopsy procedures e. Myelograms f. Percutaneous cholangiograms g. Percutaneous nephrostomies h. Sinograms or fistulograms i. T-tube cholangiograms TABLE 64-23 T INFORMATION TO BE SUBMITTED BY PERSONS PROPOSING TO CONDUCT HEALING ARTS SCREENING Persons requesting that the agency approve a healing arts screening program shall submit the following information and evaluation:
a. Name and address of the applicant and, where applicable, the names and addresses of agents within this State;
b. Diseases or conditions for which the x-ray examinations are to be used in diagnoses;
c. A detailed description of the x-ray examinations proposed in the screening program;
d. Description of the population to be examined in the screening program, i.e., age, sex, physical condition, and other appropriate information;
e. An evaluation of any known alternate methods not involving ionizing radiation which could achieve the goals of the screening program and why these methods are not used instead of the x-ray examinations;
f. An evaluation by a qualified expert of the x-ray system or systems to be used in the screening program. The evaluation by the qualified expert shall show that such system or systems do satisfy all requirements of this rule. The evaluation shall include a measurement of patient exposures from the x-ray examinations to be performed;
g. A description of the diagnostic x-ray quality control program;
h. A copy of the technique chart for the x-ray examination procedures to be used;
i. The qualifications of each individual who will be operating the x-ray system or systems;
j. The qualifications of the individual who will be supervising the operators of the x-ray system or systems. The extent of supervision and the method of work performance evaluation shall be specified;
k. The name and address of the individual who will interpret the radiographs;
l. A description of the procedures to be used in advising the individuals screened and their private practitioners of the healing arts of the results of the screening procedure and any further medical needs indicated;
m. A description of the procedures for the retention or disposition of the radiographs and other records pertaining to the x-ray examinations;
n. An indication of the frequency of screening and the duration of the entire screening program.
TABLE 64-23 U
INFORMATION ON RADIATION SHIELDING REQUIRED FOR PLAN REVIEWS
a. All Therapeutic Radiation Machines.
-
Basic facility information including: name, telephone number and agency registration number of the individual responsible for preparation of the shielding plan; name and telephone number of the facility supervisor; and the street address [including room number] of the therapeutic radiation machine facility. The plan should also indicate whether this is a new structure or a modification to existing structures.
-
All wall, floor, and ceiling areas struck by the useful beam shall have primary barriers.
-
Secondary barriers shall be provided in all wall, floor, and ceiling areas not having primary barriers.
b. Therapeutic Radiation Machines up to one hundred fifty (150) Kv (photons only). In addition to the requirements listed in Section I above, therapeutic radiation machine facilities which produce only photons with a maximum energy less than or equal to one hundred fifty (150) Kv shall submit shielding plans which contain, as a minimum, the following additional information:
-
Equipment specifications, including the manufacturer and model number of the therapeutic radiation machine, as well as the maximum technique factors;
-
Maximum design workload for the facility including total weekly radiation output, [expressed in gray (Rad) or air kerma at 1 meter], total beam-on time per day or week, the average treatment time per patient, along with the anticipated number of patients to be treated per day or week;
-
A facility blueprint or drawing indicating: scale (twenty five one-hundredths [0.25] inch = one [1] foot is typical); direction of North; normal location of the therapeutic radiation machine's radiation ports; the port's travel and traverse limits; general directions of the useful beam; locations of any windows and doors; and the location of the therapeutic radiation machine control panel. If the control panel is located inside the therapeutic radiation machine treatment room, the location of the operator's booth shall be noted on the plan and the operator's station at the control panel shall be behind a protective barrier sufficient to ensure compliance with Subsection 6.5. of this rule;
-
The structural composition and thickness or lead or concrete equivalent of all walls, doors, partitions, floor, and ceiling of the rooms concerned;
-
The type of occupancy of all adjacent areas inclusive of space above and below the rooms concerned. If there is an exterior wall, show distance to the closest areas where it is likely that individuals may be present; and 6. At least one example calculation which shows the methodology used to determine the amount of shielding required for each physical condition i.e.: primary and secondary or leakage barriers, restricted and unrestricted areas, entry doors) and shielding material in the facility:
A. If commercial software is used to generate shielding requirements, please also identify the software used and the version or revision date.
B. If the software used to generate shielding requirements is not in the open literature, please also submit quality control sample calculations to verify the result obtained with the software.
c. Therapeutic Radiation Machines Over one hundred fifty (150) Kv.
In addition to the requirements listed in Section I above, therapeutic radiation machine facilities that produce photons with a maximum energy in excess of one hundred fifty (150) Kv or electrons shall submit shielding plans which contain, as a minimum, the following additional information:
a. Equipment specifications including the manufacturer and model number of the therapeutic radiation machine, and gray (Rad) at the isocenter and the energies and types of radiation produced (i.e.: photon, electron). The target to isocenter distance shall be specified;
b. Maximum design workload for the facility including total weekly radiation output (expressed in gray [Rad] at one [1] meter), total beam-on time per day or week, the average treatment time per patient, along with the anticipated number of patients to be treated per day or week;
c. Facility blueprint or drawing (including both floor plan and elevation views) indicating relative orientation of the therapeutic radiation machine, scale (twenty five one-hundredths [0.25] inch = one [1] foot is typical), types, thickness and minimum density of shielding materials, direction of North, the locations and size of all penetrations through each shielding barrier (ceiling, walls and floor), as well as details of the doors and maze;
d. The structural composition and thickness or concrete equivalent of all walls, doors, partitions, floor, and ceiling of the rooms concerned;
e. The type of occupancy of all adjacent areas inclusive of space above and below the rooms concerned. If there is an exterior wall, show distance to the closest areas where it is likely that individuals may be present;
f. Description of all assumptions that were in shielding calculations including, but not limited to, design energy (i.e.: room may be designed for six [6] MV unit although only a four [4] MV unit is currently proposed), work-load, presence of integral beam-stop in unit, occupancy and uses of adjacent areas, fraction of time that useful beam will intercept each permanent barrier (walls, floor and ceiling) and "allowed" radiation exposure in both restricted and unrestricted areas; and g. At least one example calculation which shows the methodology used to determine the amount of shielding required for each physical condition (i.e.: primary and secondary or leakage barriers, restricted and unrestricted areas, small angle scatter, entry doors and maze) and shielding material in the facility:
- If commercial software is used to generate shielding requirements, also identify the software used and the version or revision date; and 2. If the software used to generate shielding requirements is not in the open literature, also submit quality control sample calculations to verify the result obtained with the software.
h. Neutron Shielding In addition to the requirements listed in Section iii above, therapeutic radiation machine facilities that are capable of operating above ten (10) MV shall submit shielding plans which contain, as a minimum, the following additional information:
a. The structural composition, thickness, minimum density and location of all neutron shielding material;
b. Description of all assumptions that were used in neutron shielding calculations including, but not limited to, neutron spectra as a function of energy, neutron fluence rate, absorbed dose and dose equivalent (due to neutrons) in both restricted and unrestricted areas;
c. At least one example calculation which shows the methodology used to determine the amount of neutron shielding required for each physical condition (i.e.: restricted and unrestricted areas, entry doors and maze) and neutron shielding material utilized in the facility:
- If commercial software is used to generate shielding requirements, also identify the software used and the version or revision date; and 2. If the software used to generate shielding requirements is not in the open literature, also submit quality control sample calculations to verify the result obtained with the software.
d. The methods and instrumentation that will be used to verify the adequacy of all neutron shielding installed in the facility.
e. References 1. NCRP Report 49, "Structural Shielding Design and Evaluation for Medical Use of X-rays and Gamma Rays of Energies up to 10 MeV" (1976).
-
NCRP Report 51, "Radiation Protection Design Guidelines for 0.1-100 MeV Particle Accelerator Facilities" (1977).
-
NCRP Report 79, "Neutron Contamination from Medical Electron Accelerators" (1984).
TABLE 64-23 V
QUALITY MANAGEMENT PROGRAM
a. In addition to the definitions in Subdivision 7.12.b., the following definitions are applicable to a quality management program:
- Misadministration - the administration of an external beam radiation therapy dose:
A. Involving the wrong patient, wrong treatment modality, or wrong treatment site; or, B. When the treatment consists of three (3) or fewer fractions and the calculated total administered dose differs from the total prescribed dose by more than ten (10) percent of the total prescribed dose; or C. When the calculated weekly administered dose differs from the weekly prescribed dose by more than thirty (30) percent; or D. When the calculated total administered dose differs from the total prescribed dose by more than twenty (20) percent of the total prescribed dose;
-
Prescribed dose - the total dose and dose per fraction as documented in the written directive. The prescribed dose is an estimation from measured data from a specified therapeutic radiation machine using assumptions that are clinically acceptable for that treatment technique and historically consistent with the clinical calculations previously used for patients treated with the same clinical technique;
-
Recordable event - the administration of an external beam radiation therapy dose when the calculated weekly administered dose differs by fifteen (15) percent or more from the weekly prescribed dose;
-
Written directive - an order in writing for a specific patient, dated and signed by an authorized user prior to the administration of radiation, containing the following information: total dose, dose per fraction, treatment site and overall treatment period.
b. Scope and Applicability. Each applicant or registrant subject to Subdivision 7.12.f. or 7.12.g. shall establish and maintain a written quality management program to provide high confidence that radiation will be administered as directed by the authorized user. The quality management program shall include written policies and procedures to meet the following specific objectives:
- Prior to administration, a written directive is prepared for any external beam radiation therapy dose;
A. Notwithstanding Subparagraph b.i., a written revision to an existing written directive may be made provided that the revision is dated and signed by an authorized user prior to administration of the external beam radiation therapy dose or the next external beam radiation therapy fractional dose;
B. Notwithstanding Subparagraph b.i, if, because of the patient's condition, a delay in order to provide a written revision to an existing written directive would jeopardize the patient's health, an oral revision to an existing written directive shall be acceptable, provided that the oral revision is documented immediately in the patient's record and a revised written directive is signed by an authorized user within forty eight (48) hours of the oral revision;
C. Notwithstanding Subparagraph b.i., if, because of the emergent nature of the patient's condition, a delay in order to provide a written directive would jeopardize the patient's health, an oral directive shall be acceptable, provided that the information contained in the oral directive is documented immediately in the patient's record and a written directive is prepared and signed by an authorized user within twenty four (24) hours of the oral directive.
-
Prior to the administration of each course of radiation treatments, the patient's identity is verified, by more than one method, as the individual named in the written directive;
-
External beam radiation therapy final plans of treatment and related calculations are in accordance with the respective written directives;
-
Each administration is in accordance with the written directive; and 5. Any unintended deviation from the written directive is identified and evaluated, and appropriate action is taken.
c. Development of Quality Management Program.
-
Each application for registration subject to Subdivisions 7.12.f.g. or 7.12.g. shall include a quality management program that specifies staff, duties and responsibilities, and equipment and procedures as part of the application required by Section 5. of this rule. The registrant shall implement the program upon issuance of a registration by the agency;
-
Each existing registrant subject to Subdivisions 7.12.g. or 7.12.h. shall, within thirty (30) days of July 1, 2001, submit to the agency a written certification that a quality management program has been implemented.
d. As a part of the quality management program, the registrant shall:
-
Develop procedures for, and conduct a review of, the quality management program including, since the last review, an evaluation of a representative sample of patient administrations, all recordable events, and all misadministrations to verify compliance with all aspects of the quality management program;
-
Conduct these reviews at intervals not to exceed twelve (12) months;
-
Evaluate each of these reviews to determine the effectiveness of the quality management program and, if required, make modifications to meet the requirements of Subsection b.; and 4. Maintain records of each review, including the evaluations and findings of the review, in an auditable form, for three (3) years.
e. The registrant shall evaluate and respond, within thirty (30) days after discovery of the recordable event, to each recordable event by:
-
Assembling the relevant facts including the cause;
-
Identifying what, if any, corrective action is required to prevent recurrence; and 3. Retaining a record, in an auditable form, for three (3) years, of the relevant facts and what corrective action, if any, was taken.
f. The registrant shall retain:
- Each written directive; and 2. A record of each administered radiation dose, in an auditable form, for three (3) years after the date of administration.
g. The registrant may make modifications to the quality management program to increase the program's efficiency provided the program's effectiveness is not decreased.
h. The registrant shall evaluate each misadministration and shall take the following actions in response to a misadministration:
-
Notify the agency by telephone no later than the next calendar day after discovery of the misadministration;
-
Submit a written report to the agency within fifteen (15) days after discovery of the misadministration. The written report shall include: the registrant's name; the prescribing physician's name; a brief description of the event; why the event occurred; the effect on the patient; what improvements are needed to prevent recurrence; actions taken to prevent recurrence; whether the registrant notified the patient or the patient's responsible relative or guardian (this person will subsequently be referred to as "the patient"), and if not, why not, and if the patient was notified, what information was provided to the patient. The report shall not include the patient's name or other information that could lead to identification of the patient;
-
Notify the referring physician and also notify the patient of the misadministration no later than twenty four (24) hours after its discovery, unless the referring physician personally informs the registrant either that he or she will inform the patient or that, based on medical judgment, telling the patient would be harmful. The registrant is not required to notify the patient without first consulting with the referring physician. If the referring physician or patient cannot be reached within twenty four (24) hours, the registrant shall notify the patient as soon as possible. The registrant shall not delay any appropriate medical care for the patient, including any necessary remedial care as a result of the misadministration, because of any delay in notification;
-
Retain a record of each misadministration for five (5) years. The record shall contain the names of all individuals involved (including the prescribing physician, allied health personnel, the patient, and the patient's referring physician), the patient's social security number or identification number if one has been assigned, a brief description of the event, why it occurred, the effect on the patient, what improvements are needed to prevent recurrence, and the actions taken to prevent recurrence; and 5. If the patient was notified, furnish, within fifteen (15) days after discovery of the misadministration, a written report to the patient by sending either a copy of the report that was submitted to the agency, or a brief description of both the event and the consequences as they may effect the patient, provided a statement is included that the report submitted to the agency can be obtained from the registrant;
j. Aside from the notification requirement, nothing in Paragraph 7.12.e.8. affects any rights or duties of registrants and physicians in relation to each other, patients, or the patient's responsible relatives or guardians.
TABLE 64-23 W
ALTERNATIVE QUALITY MANAGEMENT PROGRAM
a. In addition to the definitions in Subdivision 7.12.b., the following definitions are applicable to a quality management program:
- Misadministration - the administration of an external beam radiation therapy dose:
A. Involving the wrong patient, wrong treatment modality, or wrong treatment site; or, B. When the treatment consists of three (3) or fewer fractions and the calculated total administered dose differs from the total prescribed dose by more than ten (10) percent of the total prescribed dose; or C. When the calculated weekly administered dose differs from the weekly prescribed dose by more than thirty (30) percent; or D. When the calculated total administered dose differs from the total prescribed dose by more than twenty (20) percent of the total prescribed dose;
-
Recordable event - the administration of an external beam radiation therapy dose when the calculated weekly administered dose differs by fifteen (15) percent or more from the weekly prescribed dose;
-
Written directive - an order in writing for a specific patient, dated and signed by an authorized user prior to the administration of radiation, containing the following information: total dose, dose per fraction, treatment site and overall treatment period.
b. Each registrant shall establish and maintain a written program to provide assurance that radiation is administered to humans as directed by the authorized user. The program shall include the following elements:
-
Procedure for preparing written directives for the administration of radiation, however, a written directive is not required when an authorized user personally administers a dosage provided the pertinent facts are documented as otherwise required;
-
Procedure for verifying by more than one method the identity of the individual to be administered radiation;
-
Procedure for updating the therapy operating and emergency procedures manual;
-
Procedure for verifying that final plans of treatment and related calculations for brachytherapy, teletherapy, and gamma stereotactic radiosurgery are in accordance with the respective written directives;
-
Procedures assuring that administration of radiation is carried out as specified in the written directive or the therapy operating and emergency procedures manual;
-
Procedures for identifying and evaluating unintended deviations from the written directive or the therapy operating and emergency procedures manual including taking appropriate action for recordable events and misadministrations;
c. Each registrant shall evaluate and respond to misadministrations.
d. Each registrant shall evaluate and respond to recordable events within thirty (30) days after discovery by assembling the relevant facts, identifying the cause of the recordable event, and taking appropriate action, if any is required, to prevent recurrence.
e. Each registrant shall conduct an annual evaluation of the human administration program including any recommendations for changes to be made as well as any modifications made since the last evaluation and, if required, revise procedures to assure that the radiation is administered as directed by the authorized user. Modifications made to the program shall not decrease the effectiveness of the program.
f. Each registrant shall retain, in auditable form, for three (3) years:
-
Each written directive;
-
A record of each administered radiation dose where a written directive is required;
-
A record of each annual review of the program including the evaluations and findings of the review;
-
A record of each recordable event, the relevant facts, and any corrective actions taken.
TABLE 64-23 X
SUBJECTS FOR INSTRUCTION OF RADIOGRAPHER TRAINEES
Training provided to qualify individuals as radiographer trainees in compliance with subdivision 8.14.a. shall be presented on a formal basis. The training shall include the following subjects:
a. Fundamentals of Radiation Safety 1. Characteristics of radiation 2. Units of radiation dose and quantity of radioactivity 3. Significance of radiation dose A. Radiation protection standards B. Biological effects of radiation C. Case histories of radiography accidents D. Levels of radiation from sources of radiation 4. Methods of controlling radiation dose A. Working time B. Working distances C. Shielding b. Radiation Detection Instrumentation to be Used 1. Use of radiation survey instruments A. Operation B. Calibration C. Limitations 2. Survey techniques 3. Use of personnel monitoring equipment A. Film badges B. Thermoluminescent dosimeters (TLD's)
C. Pocket dosimeters c. The Requirements of Pertinent Federal and State Rules d. The Registrant's Written Operating and Emergency Procedures e. Radiographic Equipment to be Used 1. Remote handling equipment 2. Operation and control of radiographic exposure devices and sealed sources, including pictures or models of source assemblies (pigtails)
- Storage and transport containers, source changers 4. Operation and control of x-ray equipment 5. Collimators Antimony (51) Sb-122 3X10-4 Sb-124 2X10-4 Sb-125 1X10-3 Argon (18) Ar-37 1X10-3 Ar-41 4X10-7 Arsenic (33) As-73 5X10-3 As-74 5X10-4 As-76 2X10-4 As-77 8X10-4 Barium (56) Ba-131 2X10-3 Ba-140 3X10-4 Beryllium (4) Be-7 2X10-2 Bismuth (83) Bi-206 4X10-4 Bromine (35) Br-82 4X10-7 3X10-3 Cadmium (48) Cd-109 2X10-3 Cd-115m 3X10-4 Cd-115 3X10-4 Calcium (20) Ca-45 9X10-5 Ca-47 5X10-4 Carbon (6) C-14 1X10-6 8X10-3 Cerium (58) Ce-141 9X10-4 Ce-143 4X10-4 Ce-144 1X10-4 Cesium (55) Cs-131 2X10-2 Cs-134m 6X10-2 Cs-134 9X10-5 Chlorine (17) Cl-38 9X10-7 4X10-3 Chromium (24) Cr-51 2X10-2 Cobalt (27) Co-57 5X10-3 Co-58 1X10-3 Co-60 5X10-4 Copper (29) Cu-64 3X10-3 Dysprosium (66) Dy-165 4X10-3 Dy-166 4X10-4 Erbium (68) Er-169 9X10-4 Er-171 1X10-3 Europium (63) Eu-152(9.2 h) 6X10-4 Eu-155 2X10-3 Fluorine (9) F-18 2X10-6 8X10-3 Gadolinium (64) Gd-153 2X10-3 Gd-159 8X10-4 Gallium (31) Ga-72 4X10-4 Germanium (32) Ge-71 2X10-2 Gold (79) Au-196 2X10-3 Au-198 5X10-4 Au-199 2X10-3 Hafnium (72) Hf-181 7X10-4 Hydrogen (1) H-3 5X10-6 3X10-2 Indium (49) In-113m 1X10-2 In-114m 2X10-4 Iodine (53) I-126 3X10-9 2X10-5 I-131 3X10-9 2X10-5 I-132 8X10-8 6X10-4 I-133 1X10-8 7X10-5 I-134 2X10-7 1X10-3 Iridium (77) Ir-190 2X10-3 Ir-192 4X10-4 Ir-194 3X10-4 Iron (26) Fe-55 8X10-3 Fe-59 6X10-4 Krypton (36) Kr-85m 1X10-6 Kr-85 3X10-6 Lanthanum (57) La-140 2X10-4 Lead (82) Pb-203 4X10-3 Lutetium (71) Lu-177 1X10-3 Manganese (25) Mn-52 3X10-4 Mn-54 1X10-3 Mn-56 1X10-3 Mercury (80) Hg-197m 2X10-3 Hg-197 3X10-3 Hg-203 2X10-4 Molybdenum (42) Mo-99 2X10-3 Neodymium (60) Nd-147 6X10-4 Nd-149 3X10-3 Nickel (28) Ni-65 1X10-3 Niobium (Columbium) (41) Nb-95 1X10-3 Nb-97 9X10-3 Osmium (76) Os-185 7X10-4 Os-191m 3X10-2 Os-191 2X10-3 Os-193 6X10-4 Palladium (46) Pd-103 3X10-3 Pd-109 9X10-4 Phosphorus (15) P-32 2X10-4 Platinum (78) Pt-191 1X10-3 Pt-193m 1X10-2 Pt-197m 1X10-2 Pt-197 1X10-3 Potassium (19) K-42 3X10-3 Praseodymium (59) Pr-142 3X10-4 Pr-143 5X10-4 Promethium (61) Pm-147 2X10-3 Pm-149 4X10-4 Rhenium (75) Re-183 6X10-3 Re-186 9X10-4 Selenium (34) Se-75 3X10-3 Silicon (14) Si-31 9X10-3 Silver (47) Ag-105 1X10-3 Ag-110m 3X10-4 Ag-111 4X10-4 Sodium (11) Na-24 2X10-3 Strontium (38) Sr-85 1X10-3 Sr-89 1X10-4 Sr-91 7X10-4 Sr-92 7X10-4 Sulfur (16) S-35 9X10-8 6X10-4 Tantalum (73) Ta-182 4X10-4 Technetium (43) Tc-96m 1X10-1 Tc-96 1X10-3 Tellurium (52) Te-125m 2X10-3 Te-127m 6X10-4 Te-127 3X10-3 Te-129m 3X10-4 Te-131m 6X10-4 Te-132 3X10-4 Terbium (65) Tb-160 4X10-4 Thallium (81) Tl-200 4X10-3 Tl-201 3X10-3 Tl-202 1X10-3 Tl-204 1X10-3 Thulium (69) Tm-170 5X10-4 Tm-171 5X10-3 Tin (50) Sn-113 9X10-4 Sn-125 2X10-4 Tungsten (Wolfram) (74) W-181 4X10-3 W-187 7X10-4 Vanadium (23) V-48 3X10-4 Xenon (54) Xe-131m 4X10-6 Xe-133 3X10-6 Xe-135 1X10-6 Ytterbium (70) Yb-175 1X10-3 Yttrium (39) Y-90 2X10-4 Y-91m 3X10-2 Y-91 3X10-4 Y-92 6X10-4 Y-93 3X10-4 Zinc (30) Zn-65 1X10-3 Zn-69m 7X10-4 Zn-69 2X10-2 Zirconium (40) Zr-95 6X10-4 Zr-97 2X10-4 Beta or gamma emitting radioactive material not listed above with half-life of less than three (3) years. 1X10-10 1X10-6 Note 1: Many radionuclides transform into other radionuclides. In expressing the concentrations in Table 64-23 E, the activity stated is that of the parent radionuclide and takes into account the radioactive decay products.
Note 2: For purposes of Subsection 11.3. where there is involved a combination of radionuclides, the limit for the combination should be derived as follows: Determine for each radionuclide in the product the ratio between the radioactivity concentration present in the product and the exempt radioactivity concentration established in Table 64-23 Y for the specific radionuclide when not in combination. The sum of such ratios may not exceed one (1).
Example:
Concentration of Radionuclide A in Product + Concentration of Radionuclide B in Product <1 Exempt concentration of Radionuclide A Exempt concentration of Radionuclide B Note 3: To convert μCi/ml to SI units of megabecquerels per liter multiply the above values by thirty seven (37).
Example: Zirconium (40) Zr-97 (two one-thousandths [2x10-4]μCi/ml multiplied by thirty seven (37) is equivalent to seventy four one-thousandths [74 x 10-4] Mbq/l).
TABLE 64-23 Z
EXEMPT QUANTITIES
Radioactive Material Microcuries Radioactive Material Microcuries Antimony-122 (Sb 122) 100 Antimony-124 (Sb 124) 10 Antimony-125 (Sb 125) 10 Arsenic-73 (As 73) 100 Arsenic-74 (As 74) 10 Arsenic-76 (As 76) 10 Arsenic-77 (As 77) 100 Barium-131 (Ba 131) 10 Barium-133 (Ba 133) 10 Barium-140 (Ba 140) 10 Bismuth-210 (Bi 210) 1 Bromine-82 (Br 82) 10 Cadmium-109 (Cd 109) 10 Cadmium-115m (Cd 115m) 10 Cadmium-115 (Cd 115) 100 Calcium-45 (Ca 45) 10 Calcium-47 (Ca 47) 10 Carbon-14 (C 14) 100 Cerium-141 (Ce 141) 100 Cerium-143 (Ce 143) 100 Cerium-144 (Ce 144) 1 Cesium-129 (Cs 129) 100 Cesium-131 (Cs 131) 1,000 Cesium-134m (Cs 134m) 100 Cesium-134 (Cs 134) 1 Cesium-135 (Cs 135) 10 Cesium-136 (Cs 136) 10 Cesium-137 (Cs 137) 10 Chlorine-36 (Cl 36) 10 Chlorine-38 (Cl 38) 10 Chromium-51 (Cr 51) 1,000 Cobalt-57 (Co 57) 100 Cobalt-58m (Co 58m) 10 Cobalt-58 (Co 58) 10 Cobalt-60 (Co 60) 1 Copper-64 (Cu 64) 100 Dysprosium-165 (Dy 165) 10 Dysprosium-166 (Dy 166) 100 Erbium-169 (Er 169) 100 Erbium-171 (Er 171) 100 TABLE 64-23 Z EXEMPT QUANTITIES Radioactive Material Microcuries Radioactive Material Microcuries Europium-152 (Eu 152)9.2h 100 Europium-152 (Eu 152)13 yr 1 Europium-154 (Eu 154) 1 Europium-155 (Eu 155) 10 Fluorine-18 (F 18) 1,000 Gadolinium-153 (Gd 153) 10 Gadolinium-159 (Gd 159) 100 Gallium-67 (Ga 67) 100 Gallium-72 (Ga 72) 10 Germanium-68 (Ge 68) 10 Germanium-71 (Ge 71) 100 Gold-195 (Au 195) 10 Gold-198 (Au 198) 100 Gold-199 (Au 199) 100 Hafnium-181 (Hf 181) 10 Holmium-166 (Ho 166) 100 Hydrogen-3 (H 3) 1,000 Indium-111 (In 111) 100 Indium-113m (In 113m) 100 Indium-114m (In 114m) 10 Indium-115m (In 115m) 100 Indium-115 (In 115) 10 Iodine-123 (I 123) 100 Iodine-125 (I 125) 1 Iodine-126 (I 126) 1 Iodine-129 (I 129) 0.1 Iodine-131 (I 131) 1 Iodine-132 (I 132) 10 Iodine-133 (I 133) 1 Iodine-134 (I 134) 10 Iodine-135 (I 135) 10 Iridium-192 (Ir 192) 10 Iridium-194 (Ir 194) 100 Iron-52 (Fe 52) 10 Iron-55 (Fe 55) 100 Iron-59 (Fe 59) 10 Krypton-85 (Kr 85) 100 Krypton-87 (Kr 87) 10 Lanthanum-140 (La 140) 10 Lutetium-177 (Lu 177) 100 Manganese-52 (Mn 52) 10 Manganese-54 (Mn 54) 10 Manganese-56 (Mn 56) 10 Mercury-197m (Hg 197m) 100 Mercury-197 (Hg 197) 100 Mercury-203 (Hg 203) 10 Molybdenum-99 (Mo 99) 100 Neodymium-147 (Nd 147) 100 Neodymium-149 (Nd 149) 100 Nickel-59 (Ni 59) 100 Nickel-63 (Ni 63) 10 Nickel-65 (Ni 65) 100 Niobium-93m (Nb 93m) 10 Niobium-95 (Nb 95) 10 Niobium-97 (Nb 97) 10 Osmium-185 (Os 185) 10 Osmium-191m (Os 191m) 100 Osmium-191 (Os 191) 100 Osmium-193 (Os 193) 100 Palladium-103 (Pd 103) 100 Palladium-109 (Pd 109) 100 Phosphorus-32 (P 32) 10 Platinum-191 (Pt 191) 100 Platinum-193m (Pt 193m) 100 Platinum-193 (Pt 193) 100 Platinum-197m (Pt 197m) 100 Platinum-197 (Pt 197) 100 Polonium-210 (Po 210) 0.1 Potassium-42 (K 42) 10 Potassium-43 (K 43) 10 Praseodymium-142 (Pr 142) 100 Praseodymium-143 (Pr 143) 100 Promethium-147 (Pm 147) 10 Promethium-149 (Pm 149) 10 Rhenium-186 (Re 186) 100 Rhenium-188 (Re 188) 100 Rhodium-103m (Rh 103m) 100 Rhodium-105 (Rh 105) 100 TABLE 64-23 Z EXEMPT QUANTITIES Radioactive Material Microcuries Radioactive Material Microcuries Rubidium-81 (Rb 81) 10 Rubidium-86 (Rb 86) 10 Rubidium-87 (Rb 87) 10 Ruthenium-97 (Ru 97) 100 Ruthenium-103 (Ru 103) 10 Ruthenium-105 (Ru 105) 10 Ruthenium-106 (Ru 106) 1 Samarium-151 (Sm 151) 10 Samarium-153 (Sm 153) 100 Scandium-46 (Sc 46) 10 Scandium-47 (Sc 47) 100 Scandium-48 (Sc 48) 10 Selenium-75 (Se 75) 10 Silicon-31 (Si 31) 100 Silver-105 (Ag 105) 10 Silver-110m (Ag 110m) 1 Silver-111 (Ag 111) 100 Sodium-22 (Na 22) 10 Sodium-24 (Na 24) 10 Strontium-85 (Sr 85) 10 Strontium-89 (Sr 89) 1 Strontium-90 (Sr 90) 0.1 Strontium-91 (Sr 91) 10 Strontium-92 (Sr 92) 10 Sulphur-35 (S 35) 100 Tantalum-182 (Ta 182) 10 Technetium-96 (Tc 96) 10 Technetium-97m (Tc 97m) 100 Technetium-97 (Tc 97) 100 Technetium-99m (Tc 99m) 100 Technetium-99 (Tc 99) 10 Tellurium-125m (Te 125m) 10 Tellurium-127m (Te 127m) 10 Tellurium-127 (Te 127) 100 Tellurium-129m (Te 129m) 10 Tellurium-129 (Te 129) 100 Tellurium-131m (Te 131m) 10 Tellurium-132 (Te 132) 10 Terbium-160 (Tb 160) 10 Thallium-200 (Tl 200) 100 Thallium-201 (Tl 201) 100 Thallium-202 (Tl 202) 100 Thallium-204 (Tl 204) 10 Thulium-170 (Tm 170) 10 Thulium-171 (Tm 171) 10 Tin-113 (Sn 113) 10 Tin-125 (Sn 125) 10 Tungsten-181 (W 181) 10 Tungsten-185 (W 185) 10 Tungsten-187 (W 187) 100 Vanadium-48 (V 48) 10 Xenon-131m (Xe 131m) 1,000 Xenon-133 (Xe 133) 100 Xenon-135 (Xe 135) 100 Ytterbium-175 (Yb 175) 100 Yttrium-87 (Y 87) 10 Yttrium-88 (Y 88) 10 Yttrium-90 (Y 90) 10 Yttrium-91 (Y 91) 10 Yttrium-92 (Y 92) 100 Yttrium-93 (Y 93) 100 Zinc-65 (Zn 65) 10 Zinc-69m (Zn 69m) 100 Zinc-69 (Zn 69) 1,000 Zirconium-93 (Zr 93) 10 Zirconium-95 (Zr 95) 10 Zirconium-97 (Zr 97) 10 Any radioactive material not listed above other than alpha-emitting radioactive material 0.1 TABLE 64-23 Z EXEMPT QUANTITIES Note 1: For purposes of Paragraph 11.14.e.2. where there is involved a combination of radionuclides, the limit for the combination should be derived as follows:
Determine the amount of each radionuclide possessed and one thousand (1,000) times the amount in Table 64-23 Z for each of those radionuclides when not in combination. The sum of the ratios of those quantities may not exceed one (1).
Example: Amt. of Radionuclide A possessed + Amt. of Radionuclide B possessed 1 1000 x Table 64-23 Z quantity 1000 x Table 64-23 Z quantity for Radionuclide A for Radionuclide B Note 2: To convert microcuries (μCi) to SI units of kilobecquerels (kBq), multiply the above values by \thirty seven (37).
Example: Zirconium-97 (ten [10] μCi multiplied by thirty seven [37] is equivalent to three hundred seventy [370] kBq).
Antimony-122 1 0.01 Antimony-124 1 0.01 Antimony-125 1 0.01 Arsenic-73 10 0.1 Arsenic-74 1 0.01 Arsenic-76 1 0.01 Arsenic-77 10 0.1 Barium-131 10 0.1 Barium-140 1 0.01 Beryllium-7 10 0.1 Bismuth-210 0.1 1.
Bromine-82 10 0.1 Cadmium-109 1 0.01 Cadmium-115m 1 0.01 Cadmium-115 10 0.1 Calcium-45 1 0.01 Calcium-47 10 0.1 Carbon-14 100 1.
Cerium-141 10 0.1 Cerium-143 10 0.1 Cerium-144 0.1 0.001 Cesium-131 100 1.
Cesium-134m 100 1.
Cesium-134 0.1 0.001 Cesium-135 1 0.01 Cesium-136 10 0.1 Cesium-137 0.1 0.001 Chlorine-36 1 0.01 Chlorine-38 100 1.
Chromium-51 100 1.
Cobalt-57 10 0.1 Cobalt-58m 100 1.
Cobalt-58 1 0.01 Cobalt-60 0.1 0.001 Copper-64 10 0.1 Dysprosium-165 100 1.
Dysprosium-166 10 0.1 Erbium-171 10 0.1 Europium-152 (9.2 h) 10 0.1 Europium-152 (13 y) 0.1 .001 Europium-154 0.1 0.001 Europium-155 1 0.01 Fluorine-18 100 1 Gadolinium-153 1 0.01 Gadolinium-159 10 0.1 Gallium-72 10 0.1 Germanium-71 100 1.
Gold-198 10 0.1 Gold-199 10 0.1 Hafnium-181 1 0.01 Holmium-166 10 0.1 Hydrogen-3 100 1.
Indium-113m 100 1.
Indium-114m 10 .01 Indium-115m 100 1.
Indium-115 1 0.01 Iodine-125 0.1 0.001 Iodine-126 0.1 0.001 Iodine-129 0.1 0.001 Iodine-131 0.1 0.001 Iodine-132 10 0.1 Iodine-133 1 0.01 Iodine-134 10 0.1 Iodine-135 1 0.01 Iridium-192 1 0.01 Iridium-194 10 0.1 Iron-55 10 0.1 Iron-59 1 0.01 Krypton-85 100 1.
Krypton-87 10 0.1 Lanthanum-140 1 0.01 Lutetium-177 10 0.1 Manganese-52 1 0.01 Manganese-54 1 0.01 Manganese-54 10 0.1 Mercury-197m 10 0.1 Mercury-197 10 0.1 Mercury-203 1 0.01 Molybdenum-99 10 0.1 Neodymium-147 10 0.1 Neodymium-149 10 0.1 Nickel-59 10 0.1 Nickel-63 10 0.01 Nickel-65 10 0.1 Niobium-93m 1 0.01 Niobium-95 1 0.01 Niobium-97 100 1.
Osmium-185 1 0.01 Osmium-191m 100 1.
Osmium-191 10 0.1 Osmium-193 10 0.1 Palladium-103 10 0.1 Palladium-109 10 0.1 Phosphorus-32 1 0.01 Platinum-191 10 0.1 Platinum-193m 100 1.
Platinum-193 10 0.1 Platinum-197m 100 1.
Platinum-197 10 0.1 Polonium-210 0.01 0.0001 Potassium-142 1 0.01 Praseodymium-142 10 0.1 Praseodymium-143 10 0.1 Promethium-147 1 0.01 Promethium-149 10 0.1 Radium-226 0.01 0.0001 Rhenium-186 10 0.1 Rhenium-188 10 0.1 Rhodium-103m 1,000 10.
Rhodium-105 10 0.1 Rubidium-86 1 0.01 Rubidium-87 1 0.01 Ruthenium-97 100 1.
Ruthenium-103 1 0.01 Ruthenium-105 10 0.1 Ruthenium-106 0.1 0.001 Samarium-151 1 0.01 Samarium-153 10 0.1 Scandium-46 1 0.01 Scandium-47 10 0.1 Scandium-48 1 0.01 Selenium-75 1 0.01 Silicon-31 10 0.1 Silver-105 1 0.01 Silver-110m 1 0.001 Silver-111 10 0.1 Sodium-22 0.1 0.001 Sodium-24 1 0.01 Strontium-85m 1,000 10.
Strontium-85 1 0.01 Strontium-89 10 .01 Strontium-90 0.01 0.001 Strontium-91 10 0.1 Strontium-92 10 0.1 Sulphur-35 10 0.1 Tantalum-182 1 0.01 Technetium-96 10 0.1 Technetium-97m 1 0.1 Technetium-97 10 0.1 Technetium-99m 100 1.
Technetium-99 1 0.01 Tellurium-125m 1 0.01 Tellurium-127m 1 0.01 Tellurium-127 10 0.1 Tellurium-129m 1 0.01 Tellurium-129 100 1.
Tellurium-131m 10 0.1 Tellurium-132 1 0.01 Terbium-160 1 0.01 Thallium-200 10 0.1 Thallium-201 10 0.1 Thallium-202 10 0.1 Thallium-204 1 0.01 Thulium-170 1 0.01 Thulium-171 1 0.01 Tin-113 1 0.01 Tin-125 1 0.01 Tungsten-181 1 0.01 Tungsten-185 1 0.01 Tungsten-187 10 0.1 Vanadium-48 1 0.01 Xenon-131m 1,000 10 Xenon-133 100 1.
Xenon-135 100 1.
Ytterbium-175 10 0.1 Yttrium-90 1 0.01 Yttrium-91 1 0.01 Yttrium-92 10 0.1 Yttrium-93 1 0.01 Zinc-65 1 0.01 Zinc-69m 10 0.1 Zinc-69 100 1.
Zirconium-93 1 0.01 Zirconium-95 1 0.01 Zirconium-97 1 0.01 Any radioactive material other than source material, special nuclear material, or alpha emitting radioactive material not listed above. 0.1 0.001 Note 1: To convert curies (Ci) to SI units of gigabecquerels (GBq), multiply the above values by thirty seven (37).
Example: Zirconium-97 (Col. II) (one one-hundredth [0.01] Ci multiplied by thirty seven [37] is equivalent to thirty seven one-thousandths [0.37] GBq).
TABLE 64-23 Bb Uranium enrichment in weight percent of Permissible maximum grams of Uranium-235 not exceeding Uranium-235 per package 24 40 20 42 15 45 11 48 10 51
9.5 52 9 54
8.5 55 8 57
7.5 59 7 60
6.5 62 6 65
5.5 68 5 72
4.5 76 4 80
3.5 88 3 100
2.5 120 2 164
1.5 272
1.35 320 1 680 *
0.92 1200 * TABLE 64-23 Cc Uranium enrichment in weight percent of Permissible maximum grams Uranium-235 not exceeding of Uranium-235 per package 4 84
3.5 92 3 112
2.5 148 2 240
1.5 560 * * Pursuant to the agency's agreement with the NRC, jurisdiction extends only to three hundred fifty (350) grams of uranium.
TABLE 64-23 Dd Removable External Radioactive Contamination Wipe Limits Maximum Permissible Limits Contaminant μCi/cm2* dpm/cm2 Beta-gamma emitting radionuclides; all radionuclides with half-lives less than ten days; natural uranium; natural thorium; Uranium-235;
Uranium-238; Thorium-232; Thorium-228 and Thorium-230 when contained in ores or physical concentrates ............. 10-5 22 All other alpha emitting radionuclides ...................................... 10-6 2.2 TABLE 64-23 Ee DETERMINATION OF A1 AND A2 a. Single Radionuclides 1. For a single radionuclide of known identity, the values of A1 and A2 are taken from table i if listed there. The values A1 and A2 in Table 64-23 Ee A are also applicable for the radionuclide contained in (α,n) or (γ,n) neutron sources.
- For any single radionuclide whose identity is known but which is not listed in Table 64-23 Ee A, the value of A1 and A2 are determined according to the following procedure:
A. If the radionuclide emits only one type of radiation, A1 is determined according to the following method. For radionuclides emitting different kinds of radiation, A1 is the most restrictive value of those determined for each kind of radiation. However, in either case, A1 is restricted to a maximum of one thousand (1000) curies (thirty seven [37] TBq). If a parent nuclide decays into a shorter lived daughter with a half-life not greater than ten (10) days, A1 is calculated for both the parent and the daughter, and the more limiting of the two values is assigned to the parent nuclide.
TABLE 64-23 Ee DETERMINATION OF A1 AND A2 B. For gamma emitters, A1 is determined by the expression:
A1 = Nine (9) curies Γ where Γ is the gamma-ray constant, corresponding to the dose in roentgens per curie-hour at one (1) meter, and the number nine (9) results from the choice of one (1) Rem per hour at a distance of three (3) meters as the reference dose-equivalent rate.
C. For x-ray emitters, A1 is determined by the atomic number of the nuclide: for Z 55, A1 = One thousand (1000) Ci (thirty seven [37] TBq); and for Z > 55, A1 = Two hundred (200) Ci (seven and four-tenths [7.4] TBq) where Z is the atomic number of the nuclide.
D. For beta emitters, A1 is determined by the maximum beta energy (Emax) according to Table 64-23 Ee B; and E. For alpha emitters, A1 is determined by the expression:
A1 = 1000 A3 where A3 is the value listed in Table 63-23 Ee C;
F. A2 is the more restrictive of the following two values:
-
The corresponding A1; and 2. The value A3 obtained from table 64-23 Ee C.
-
For any single radionuclide whose identity is unknown, the value of A1 is taken to be 2 Ci (74 GBq) and the value of A2 is taken to be 0.002 Ci (74 MBq). However, if the atomic number of the radionuclide is known to be less than 82, the value of A1 is taken to be 10 Ci (370 GBq) and the value of A2 is taken to be 0.4 Ci (14.8 GBq).
b. Mixtures of Radionuclides, Including Radioactive Decay Chains TABLE 64-23 Ee DETERMINATION OF A1 AND A2 1. For mixed fission products, the activity limit may be assumed if a detailed analysis of the mixture is not carried out, A1 = 10 Ci (370 GBq)
A2 = 0.4 Ci (14.8 GBq)
-
A single radioactive decay chain is considered to be a single radionuclide when the radionuclides are present in their naturally occurring proportions and no daughter nuclide has a half-life either longer than ten (10) days or longer than that of the parent nuclide. The activity to be taken into account and the A1 or A2 value from Table Ee A to be applied are those corresponding to the parent nuclide of that chain. When calculating A1 or A2 values, radiation emitted by daughters must be considered. However, in the case of radioactive decay chains in which any daughter nuclide has a half-life either longer than ten (10) days or greater than that of the parent nuclide, the parent and daughter nuclides are considered to be mixtures of different nuclides.
-
In the case of a mixture of different radionuclides, where the identity and activity of each radionuclide are known, the permissible activity of each radionuclide R1, R2 . . . Rn is such that F1 + F2 + . . . Fn is not greater than unity, where:
F1 = Total activity of R1 Ai(R1)
F2 = Total activity of R2 Ai(R2)
Fn = Total activity of Rn Ai(Rn) and Ai (R1, R2. .Rn) is the value of A1 or A2 as appropriate for the nuclide R1, R2. .Rn.
-
When the identity of each radionuclide is known but the individual activities of some of the radionuclides are not known, the formula given in Paragraph 3. is applied to establish the values of A1 or A2 as appropriate. All the radionuclides whose individual activities are not known (their total activity will, however, be known) are classed in a single group and the most restrictive value of A1 and A2 applicable to any one of them is used as the value of A1 or A2 in the denominator of the fraction.
-
Where the identity of each radionuclide is known but the individual activity of none of the radionuclides is known, the most restrictive value of A1 or A2 applicable to any one of the radionuclides present is adopted as the applicable value.
TABLE 64-23 Ee DETERMINATION OF A1 AND A2 6. When the identity of none of the nuclides is known, the value of A1 is taken to be two (2) Ci (seventy four [74] GBq) and the value of A2 is taken to be two one-thousandths (0.002) Ci (seventy four [74] MBq). However, if alpha emitters are known to be absent, the value of A2 is taken to be four tenths (0.4) Ci (fourteen and eight tenths [14.8] GBq).
Ac-227 Actinium (89) 1000 0.003 7.2 x 101 Ac-228 10 4 2.2 x 106 Ag-105 Silver (47) 40 40 3.1 x 104 Ag-110m 7 7 4.7 x 103 Ag-111 Silver (47) 100 20 1.6 x 105 Am-241 Americium (95) 8 0.008 3.2 Am-243 8 0.008 1.9 x 10-1 Ar-37 (compressed or 1000 1000 1.0 x 105 Argon uncompressed)* Ar-41 (uncompressed)* 20 2 4.3 x 107 Ar-41 (compressed)* 1 1 4.3 x 107 As-73 Arsenic (33) 1000 400 2.4 x 104 As-74 20 20 1.0 x 105 As-76 10 10 1.6 x 106 As-77 300 20 1.1 x 106 At-211 Astatine (85) 200 7 2.1 x 106 Au-193 Gold (79) 200 200 9.3 x 105 Au-196 30 30 1.2 x 105 Au-198 40 20 2.5 x 105 Au-199 200 25 2.1 x 105 Ba-131 Barium (56) 40 40 8.7 x 104 Ba-133 40 40 4.0 x 102 Ba-140 20 20 7.3 x 104 Be-7 Beryllium (4) 300 300 3.5 x 105 Bi-206 Bismuth (83) 5 5 9.9 x 104 Bi-207 Bismuth (83) 10 10 2.2 x 102 Bi-210 (RaE) 100 4 1.2 x 105 Bi-212 6 6 1.5 x 107 Bk-249 Berkelium (97) 1000 1 1.8 x 103 Br-77 Bromine (35) 70 25 7.1 x 105 Br-82 6 6 1.1 x 106 C-11 Carbon (6) 20 20 8.4 x 108 C-14 1000 60 4.6 Ca-45 Calcium (20) 1000 25 1.9 x 104 Ca-47 20 20 5.9 x 105 Cd-109 Cadmium (48) 1000 70 2.6 x 103 Cd-115m 30 30 2.6 x 104 Cd-115 80 20 5.1 x 105 Ce-139 Cerium (58) 100 100 6.5 x 103 Ce-141 300 25 2.8 x 104 Ce-143 60 20 6.6 x 105 Ce-144 10 7 3.2 x 103 Cf-249 Californium (98) 2 0.002 3.1 Cf-250 7 0.007 1.3 x 102 Cf-252 2 0.009 6.5 x 102 Cl-36 Chlorine (17) 300 10 3.2 x 10-2 Cl-38 10 10 1.3 x 108 Cm-242 Curium (96) 200 0.2 3.3 x 103 Cm-243 9 0.009 4.2 x 101 Cm-244 10 0.01 8.2 x 101 Cm-245 6 0.006 1.0 x 10-1 Cm-246 6 0.006 3.6 x 10-1 Co-56 Cobalt (27) 5 5 3.0 x 104 Co-57 90 90 8.5 x 103 Co-58m 1000 1000 5.9 x 106 Co-58 20 20 3.1 x 104 Co-60 7 7 1.1 x 103 Cr-51 Chromium (24) 600 600 9.2 x 104 Cs-129 Cesium (55) 40 40 7.6 x 105 Cs-131 1000 1000 1.0 x 105 Cs-134m 1000 10 7.4 x 106 Cs-134 10 10 1.2 x 103 Cs-135 1000 25 8.8 x 10-4 Cs-136 7 7 7.4 x 104 Cs-137 30 10 9.8 x 101 Cu-64 Copper (29) 80 25 3.8 x 106 Cu-67 200 25 7.9 x 105 Dy-165 Dysprosium (66) 100 20 8.2 x 106 Dy-166 1000 200 2.3 x 105 Er-169 Erbium (68) 1000 25 8.2 x 104 Er-171 50 20 2.4 x 106 Eu-152m Europium (63) 30 30 2.2 x 106 Eu-152 20 10 1.9 x 102 Eu-154 10 5 1.5 x 102 Eu-155 400 60 1.4 x 103 F-18 Fluorine (9) 20 20 9.3 x 107 Fe-55 1000 1000 2.2 x 103 Fe-59 10 10 4.9 x 104 Ga-67 Gallium (31) 100 100 6.0 x 105 Ga-68 20 20 4.0 x 107 Ga-72 7 7 3.1 x 106 Gd-153 Gadolinium (64) 200 100 3.6 x 103 Gd-159 300 20 1.1 x 106 Ge-68 Germanium (32) 20 10 7.0 x 103 Ge-71 1000 1000 1.6 x 105 H-3 Hydrogen (1) see T-Tritium Hf-181 Hafnium (72) 30 25 1.6 x 104 Hg-197m Mercury (80) 200 200 6.6 x 105 Hg-197 200 200 2.5 x 105 Hg-203 80 25 1.4 x 104 Ho-166 Holmium (67) 30 30 6.9 x 105 I-123 Iodine (53) 50 50 1.9 x 106 I-125 1000 70 1.7 x 104 I-126 40 10 7.8 x 104 I-129 1000 2 1 .6 x 10-4 I-131 40 10 1.2 x 105 I-132 7 7 1.1 x 107 I-133 30 10 1.1 x 106 I-134 8 8 2.7 x 107 I-135 10 10 3.5 x 106 In-111 Indium (49) 30 25 4.2 x 105 In-113m 60 60 1.6 x 107 In-114m 30 20 2.3 x 104 In-115m Indium (49) 100 20 6.1 x 106 Ir-190 Iridium (77) 10 10 6.2 x 104 Ir-192 20 10 9.1 x 103 Ir-194 10 10 8.5 x 105 K-42 Potassium (19) 10 10 6.0 x 106 K-43 20 10 3.3 x 106 Kr-85m (uncompressed)Krypton (36) 100 100 8.4 x 106 Kr-85m (compressed) 3 3 8.4 x 106 Kr-85 (uncompressed)* 1000 1000 4.0 x 102 Kr-85 (compressed)* 5 5 4.0 x 102 Kr-87 (uncompressed)* 20 20 2.8 x 107 Kr-87 (compressed)* 0.6 0.6 2.8 x 107 La-140 Lanthanum (57) 30 30 5.6 x 105 Lu-177 Lutetium (71) 300 25 1.1 x 105 MFP Mixed Fission 10 0.4 --------- Products Mg-28 Magnesium (12) 6 6 5.2 x 106 Mn-52 Manganese (25) 5 5 4.4 x 105 Mn-54 20 20 8.3 x 103 Mn-56 5 5 2.2 x 107 Mo-99 Molybdenum (42) 100 20 4.7 x 105 N-13 Nitrogen (7) 20 10 1.5 x 109 Na-22 Sodium (11) 8 8 6.3 x 103 Na-24 5 5 8.7 x 106 Nb-93m Niobium (41) 1000 200 1.1 x 103 Nb-95 20 20 3.9 x 104 Nb-97 20 20 2.6 x 107 Nd-147 Neodymium (60) 100 20 8.0 x 104 Nd-149 30 20 1.1 x 107 Ni-59 Nickel (28) 1000 900 8.1 x 10-2 Ni-63 1000 100 4.6 x 101 Ni-65 10 10 1.9 x 107 Np-237 Neptunium (93) 5 0.005 6.9 x 10-4 Np-239 200 25 2.3 x 105 Os-185 Osmium (76) 20 20 7.3 x 103 Os-191 600 200 4.6x 104 Os-191m 200 200 1.2 x 106 Os-193 100 20 5.3 x 105 P-32 Phosphorus (15) 30 30 2.9 x 105 Pa-230 Protactinium (91) 20 0.8 3.2 x 104 Pa-231 2 0.002 4.5 x 10-2 Pa-233 Protactinium (91) 100 100 2.1 x 104 Pb-201 Lead (82) 20 20 1.7 x 106 Pb-210 100 0.2 8.8 x 101 Pb-212 6 5 1.4 x 106 Pd-103 Palladium (46) 1000 700 7.5 x 104 Pd-109 100 20 2.1 x 106 Pm-147 Promethium (61) 1000 25 9.4 x 102 Pm-149 100 20 4.2 x 105 Po-210 Polonium (84) 200 0.2 4.5 x 103 Pr-142 Praseodymium (59) 10 10 1.2 x 104 Pr-143 300 20 6.6 x 104 Pt-191 Platinum (78) 100 100 2.3 x 105 Pt-193m 200 200 2.0 x 105 Pt-197m 300 20 1.2 x 107 Pt-197 300 20 8.8 x 105 Pu-238 Plutonium (94) 3 0.003 1.7 x 101 Pu-239 2 0.002 6.2 x 10-2 Pu-240 2 0.002 2.3 x 10-1 Pu-241 1000 0.1 1.1 x 102 Pu-242 3 0.003 3.9 x 10-3 Ra-223 Radium (88) 50 0.2 5.0 x 104 Ra-224 6 0.5 1.6 x 105 Ra-226 10 0.05 1.0 Ra-228 10 0.05 2.3 x 102 Rb-81 Rubidium (37) 30 24 8.2 x 106 Rb-86 30 30 8.1 x 104 Rb-87 Unlimited Unlimited 1.6 x 10-8 Rb (natural) Unlimited Unlimited 1.8 x 10-8 Re-186 Rhenium (75) 100 20 1.9 x 105 Re-187 Unlimited Unlimited 3.8 x 10-8 Re-188 10 10 1.0 x 106 Re (natural) Unlimited Unlimited 2.4 x 10-8 Rh-103m Rhodium (45) 1000 1000 3.2 x 107 Rh-105 200 25 8.2 x 105 Rn-222 Radon (86) 10 2 1.5 x 105 Ru-103 30 25 3.2 x 104 Ru-105 20 20 6.6 x 106 Ru-106 10 7 3.4 x 103 S-35 Sulphur (16) 1000 60 4.3 x 104 Sb-122 Antimony (51) 30 30 3.9 x 105 Sb-124 5 5 1.8 x 104 Sb-125 40 25 1.4 x 103 Sc-46 Scandium (21) 8 8 3.4 x 104 Sc-47 200 20 8.2 x 105 Sc-48 5 5 1.5 x 106 Se-75 Selenium (34) 40 40 1.4 x 104 Si-31 Silicon (14) 100 20 3.9 x 107 Sm-147 Samarium (62) Unlimited Unlimited 2.0 x 10-8 Sm-151 1000 90 2.6 x 101 Sm-153 300 20 4.4 x 105 Sn-113 Tin (50) 60 60 1.0 x 104 Sn-119m 100 100 4.4 x 103 Sn-125 10 10 1.1 x 105 Sr-85m Strontium (38) 80 80 3.2 x 107 Sr-85 30 30 2.4 x 104 Sr-87 50 50 1.2 x 107 Sr-89 100 10 2.9 x 104 Sr-90 10 0.4 1.5 x 102 Sr-91 10 10 3.6 x 106 Sr-92 Strontium (38) 10 10 1.3 x 107 T (uncompressed)* Tritium (1) 1000 1000 9.7 x 103 T (compressed)* 1000 1000 9.7 x 103 T (activated luminous paint) 1000 1000 9.7 x 103 T (adsorbed on solid carrier) 1000 1000 9.7 x 103 T (tritiated water) 1000 1000 9.7 x 103 T (other forms) 20 20 9.7 x 103 Ta-182 Tantalum (73) 20 20 6.2 x 103 Tb-160 Terbium (65) 20 10 1.1 x 104 Tc-96m Technetium (43) 1000 1000 3.8 x 107 Tc-96 6 6 3.2 x 105 Tc-97m 1000 200 1.5 x 104 Tc-97 1000 400 1.4 x 10-3 Tc-99m 100 100 5.2 x 106 Tc-99 1000 25 1.7 x 10-2 Te-125m Tellurium (52) 1000 100 1.8 x 104 Te-127m 300 20 4.0 x 104 Te-127 300 20 2.6 x 106 Te-129m 30 10 2.5 x 104 Te-129 100 20 2.0 x 107 Te-131m Tellurium (52) 10 10 8.0 x 105 Te-132 7 7 3.1 x 105 Th-227 Thorium (90) 200 0.2 3.2 x 104 Th-228 6 0.008 8.3 x 102 Th-230 3 0.003 1.9 x 10-2 Th-231 1000 25 5.3 x 105 Th-232 Unlimited Unlimited 1.1 x 10-7 Th-234 10 10 2.3 x 104 Th (natural) Unlimited Unlimited 2.2 x 10-7 Th (irradiated)** --- --- --- Tl-200 Thallium (81) 20 20 5.8 x 105 Tl-201 200 200 2.2 x 105 Tl-202 40 40 5.4 x 104 Tl-204 300 10 4.3 x 102 Tm-170 Thulium (69) 300 10 6.0 x 103 Tm-171 1000 100 1.1 x 103 U-230 Uranium (92) 100 0.1 2.7 x 104 U-232 30 0.03 2.1 x 101 U-233 100 0.1 9.5 x 10-3 U-234 100 0.1 6.2 x 10-3 U-235 Uranium (92) 100 0.2 2.1 x 10-6 U-236 200 0.2 6.3 x 10-5 U-238 Unlimited Unlimited 3.3 x 10-7 U (natural) Unlimited Unlimited (see Table 64-23 Ee D)
U (enriched) <20% Unlimited Unlimited (see Table
64-23 Ee D) 20% or greater 100 0.1 (see Table
64-23 Ee D)
U (depleted) Unlimited Unlimited (see Table
64-23 Ee D)
U (irradiated)*** --- --- --- V-48 Vanadium (23) 6 6 1.7 x 105 W-181 Tungsten (74) 200 100 5.0 x 103 W-185 1000 25 9.7 x 10-3 W-187 40 20 7.0 x 105 Xe-127 (uncompressed)* Xenon (54) 70 70 2.8 x 104 Xe-127 (compressed)* 5 5 2.8 x 104 Xe-131m (compressed)* 10 10 1.0 x 105 Xe-131m (uncompressed)* 100 100 1.0 x 105 Xe-133 (uncompressed)* 1000 1000 1.9 x 105 Xe-33 (compressed)* 5 5 1.9 x 105 Xe-135 (uncompressed)* 70 70 2.5 x 105 Xe-135 (compressed)* 2 2 2.5 x 105 Y-87 Yttrium (39) 20 20 4.5 x 101 Y-90 10 10 2.5 x 105 Y-91m 30 30 4.1 x 107 Y-91 30 30 2.5 x 104 Y-92 10 10 9.5 x 106 Y-93 10 10 3.2 x 106 Yb-19 Ytterbium (70) 80 80 2.3 x 105 Yb-175 400 25 1.8 x 105 Zn-65 Zinc (30) 30 30 8.0 x 103 Zn-69m 40 20 3.3 x 106 Zn-69 300 20 5.3 x 107 Zr-93 Zirconium (40) 1000 200 3.5 x 10-3 Zr-95 20 20 2.1 x 104 Zr-97 20 20 2.0 x 106 * For the purpose of Table Ee A, compressed gas means a gas at a pressure which exceeds the ambient atmospheric pressure at the location where the containment system was closed. ** The values of A1 and A2 must be calculated in accordance with the procedure specified in Table 64-23 Ee, Paragraph ii 3., taking into account the activity of the fission products and of the Uranium-233 in addition to that of the thorium. *** The values of A1 and A2 must be calculated in accordance with the procedure specified in Table 64-23 Ee, Paragraph ii 3., taking into account the activity of the fission products and plutonium isotopes in addition to that of the uranium.
TABLE 64-23 Ee B Relationship Between A1 and Emax for Beta Emitters Emax(MeV) A1(Ci) < 0.5 1000
0.5 - < 1.0 300
1.0 - < 1.5 100
1.5 - < 2.0 30 2.0 10 TABLE 64-23 Ee C Relationship Between A3 and the Atomic Number of the Radionuclide A3 Atomic Half-life less Half-life 1000 days Half-life greater Number than 1000 days to 106 years than 106 years 1 to 81 3 Ci 0.05 Ci 3 Ci 82 and above 0.002 Ci 0.002 Ci 3 Ci TABLE 64-23 Ee D Activity-Mass Relationships for Uranium/Thorium Thorium and Uranium Enrichment* Specific Activity wt % U-235 present Ci/g g/Ci
0.45 5.0 x 10-7 2.0 x 106
0.72 (natural) 7.06 x 10-7 1.42 x 106
1.0 7.6 x 10-7 1.3 x 106
1.5 1.0 x 10-6 1.0 x 106
5.0 2.7 x 10-6 3.7 x 105
10.0 4.8 x 10-6 2.1 x 105
20.0 1.0 x 10-5 1.0 x 105
35.0 2.0 x 10-5 5.0 x 104
50.0 2.5 x 10-5 4.0 x 104
90.0 5.8 x 10-5 1.7 x 104
93.0 7.0 x 10-5 1.4 x 104
95.0 9.1 x 10-5 1.1 x 104 Natural Thorium 2.2 x 10-7 4.6 x 106 TABLE 64-23 Ff SUBJECTS TO BE INCLUDED IN TRAINING COURSES FOR LOGGING SUPERVISORS a. Fundamentals of Radiation Safety 1. Characteristics of radiation 2. Units of radiation dose and quantity of radioactivity 3. Significance of radiation dose A. Radiation protection standards B. Biological effects of radiation dose 4. Levels of radiation from sources of radiation 5. Methods of minimizing radiation dose TABLE 64-23 Ff SUBJECTS TO BE INCLUDED IN TRAINING COURSES FOR LOGGING SUPERVISORS A. Working time B. Working distances C. Shielding 6. Radiation safety practices including prevention of contamination and methods of decontamination b. Radiation Detection Instrumentation to be Used 1. Use of radiation survey instruments 2. Operation 3. Calibration 4. Limitations 5. Survey techniques 6. Use of personnel monitoring equipment c. Equipment to be Used 1. Handling equipment 2. Sources of radiation 3. Storage and control of equipment 4. Operation and control of equipment d. The Requirements of Pertinent Federal and State Regulations e. The Registrant's Written Operating and Emergency Procedures f. The Registrant's Record Keeping Procedures TABLE 64-23 Gg EXAMPLE OF PLAQUE FOR IDENTIFYING WELLS CONTAINING SEALED SOURCES CONTAINING RADIOACTIVE MATERIAL ABANDONED DOWNHOLE If you desire a copy of the graphic, please contact:
West Virginia Radiological Health Program. 815 Quarrier Street Charleston, West Virginia 25301 (304) 558-3526 The size of the plaque should be convenient for use on active or inactive wells, e.g., a seven (7) inch square. Letter size of the word "CAUTION" should be approximately twice the letter size of the rest of the information, e.g., one half (2) inch and one quarter (3) inch letter size, respectively.
TABLE 64-23 Hh
Part of Body Column I* Dose Column II* Dose Column III* Dose Whole body; head and trunk; active blood-forming organs; gonads; or lens of eye
0.05 mSv (0.005 Rem) 5 mSv (0.5 Rem) 150 mSv (15 Rem )
Hands and forearms; feet and ankles; localized areas of skin averaged over areas no larger than 1 square centimeter
0.75 mSv (0.075 Rem) 75 mSv (7.5 Rem) 2000 mSv (200 Rem )
Other organs 0.15mSv (0.015 Rem) 15 mSv (1.5 Rem) 500 mSv (50 Rem) *Dose limit is the dose above background from the product.
TABLE 64-23 Ii ACCEPTABLE SURFACE CONTAMINATION1 LEVELS FOR TENORM AVERAGE2, 3, 6 MAXIMUM2, 4, 6 REMOVABLE2, 3, 5, 6 Alpha 5,000 dpm/100 cm2 15,000 dpm /100 cm2 1,000 dpm /100 cm2 Beta-gamma 5,000 dpm/100 cm2 15,000 dpm /100 cm2 1,000 dpm /100 cm2 1 Where surface contamination by both alpha and beta-gamma emitting nuclides exists, the limits established for alpha and beta-gamma emitting nuclides should apply independently. 2 As used in this table, dpm (disintegrations per minute) means the rate of emission by radioactive material as determined by correcting the counts per minute observed by an appropriate detector for background, efficiency, and geometric factors associated with the instrumentation. 3 Measurements of average contamination level should not be averaged over more than one (1) square meter. For objects of less surface area, the average should be derived for each object. 4 The maximum contamination level applies to an area of not more than one hundred (100) cm2. 5 The amount of removable radioactive material per one hundred (100) cm2 of surface area should be determined by wiping that area with dry filter or soft absorbent paper, applying moderate pressure, and assessing the amount of radioactive material on the wipe with an appropriate instrument of known efficiency. When removable contamination on objects of surface area A (where A is less than one hundred [100] sq. cm) is determined, the entire surface should be wiped and the contamination level multiplied by 100/A to convert to a Aper one hundred (100) sq cm@ basis. 6 The average and maximum radiation levels associated with surface contamination resulting from beta-gamma emitters should not exceed two tenths (0.2) mRad/hr (two [2] μGy/hr) at one (1) cm and one (1.0) mR/hr (ten [10] μGy/hr) at one (1) cm, respectively, measured through not more than seven (7) milligrams per square centimeter of total absorber. 1 At very high doses received at high dose rates, units of absorbed dose, gray and rad, are appropriate, rather than units of dose equivalent, Sievert and Rem. 2 Labeled means labeled with a Radioactive White I, Yellow II or Yellow III label as specified in Department of Transportation Regulations 49 CFR .403 and 172.436-440. 3 Labeling of packages containing radioactive materials is required by the Department of Transportation if the amount and type of radioactive material exceeds the limits for an excepted quantity or article as defined and limited by Department of Transportation regulations 49 CFR 173.403 (m) (w) and 173.421 - 424. 4 Labeled means labeled with a radioactive white I, yellow II or yellow III label as specified in Department of Transportation regulations 49 CFR 173.403 and 172.436 - 440. 5 Materials should be placed in the useful beam to protect the imaging system when conducting these periodic measurements. 6 For the purpose of determining the CTDI, the manufacturer's statement as to the nominal tomographic Section thickness for that particular system may be utilized. 7 The requirements specified in Subdivisions 11.2.c.2. and 3. need not be met by counterweights manufactured prior to December 31, 1969; provided, that such counterweights are impressed with the legend, "CAUTION - RADIOACTIVE MATERIAL - URANIUM", as previously required by the rules. 8 Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing byproduct material whose subsequent possession, use, transfer, and disposal by all other persons are exempted from regulatory requirements may be obtained only from the NRC, Washington, D.C. 20555 9 Authority to transfer possession or control by the manufacturer, processor, or producer of any 10 The model, serial number and name of the manufacturer or distributor may be omitted from this label provided the information is elsewhere specified in labeling affixed to the device. 11 Although the agency does not regulate the manufacture and distribution of reagent kits that do not contain radioactive material, it does regulate the use of such reagent kits for the preparation of radiopharmaceuticals containing radioactive material as part of its registration and rule of the users of radioactive material. Any manufacturer of reagent kits that do not contain radioactive material who desires to have his reagent kits approved by the agency for use by persons registered pursuant to Subsection 11.32. of this rule may submit the pertinent information specified in Subdivision 11.17.j. 12 The term “exclusive use” is used interchangeably with the terms “sole use” or “full load” or in other regulations, such as Title 49 of the Code of Federal Regulations. 13 Agency jurisdiction extends only to special nuclear material if quantities are not sufficient to form a critical mass as defined in §64-23-1. 14 Any notification of incidents referred to in those DOT requirements shall be filled with, or made to the agency. 15 A flat-bed style vehicle with a personnel barrier shall have radiation levels determined at vertical planes. If no personnel barrier, the package cannot exceed 200 millirems per hour (2 mSv/h) at the surface. 16 or CAUTION 17 or CAUTION 18 An example of the suggested plaque is shown in Table 64-23 Gg. 19 Appropriate warnings may include: (a) “Do not drill below plug-back depth”; (b) “do not enlarge casting”; or (c) “Do not re-enter the Hole”, followed by the words, “before contacting the WV Radiological Health Program”.
See explanation at the end of this listing. c See section 3.66 of these rules for definition of pyrophoric material. a To convert μCi to kBq, multiply the μCi value by 37. a To convert μCi to kBq, multiply the μCi value by 37. a To convert μCi to kBq, multiply the μCi value by 37. aa Based on alpha disintegration rate of Th-232, Th-230 and their daughter products. aaa Based on alpha disintegration rate of U-238, U-234, and U-235.
FUNC { 175~(grams~contained~U-235) } OVER 350~FUNC+~FUNC { 50~(grams~U-233) } OVER 200~FUNC+~FUNC { 50~(grams~Pu) } OVER 200~ =~1 OVERLINE FUNC {CTDI}~~=~~1 OVER {FUNC n~FUNC T}~ INT_{-7 FUNC T} SUP {+7 FUNC T} FUNC D(FUNC z)~ FUNC dz {OVERLINE FUNC CS}~~=~~{FUnc mu SUB x~-~ FUNC mu SUB w} OVER {{OVERLINE FUNC CTN}_FUNC x ~-~ {OVERLINE FUNC CTN}_FUNC w} {OVERLINE FUNC CTN}~~=~~{FUNC k~(FUnc mu SUB x~-~ FUNC mu SUB w)} OVER { mu_func w} FUNC S_FUNC n~~=~~{100 ~ CDOT ~ {OVERLINE FUNC CS} ~ CDOT ~ FUNC s} OVER { mu_func w}
Series 24 Newborn Hearing Screening
W. Va. Code R. § 64-24-1 General
1.1. Scope. -- This rule establishes a reasonable fee schedule, a cost-effective screening protocol, and reporting and referral requirements for the screening of newborn infants for hearing impairments, and becomes effective on July 1, 2001. This rule should be read in conjunction with W. Va. Code '16-22A-1 et seq. The W. Va. Code is available in public libraries and on the Legislature=s webpage, http://www.legis.state.wv.us/.
1.2. Authority. -- W. Va. Code '16-22A-2 and 16-1-7.
1.3. Filing Date. -- May 4, 2001.
1.4. Effective Date. -- July 1, 2001.
W. Va. Code R. § 64-24-2 Application and Enforcement
2.1. Application. -- This rule applies to all infants born in West Virginia and to the health care providers caring for infants at birth.
2.2. Enforcement. -- This rule is enforced by the director of the division of health.
W. Va. Code R. § 64-24-3 Definitions
3.1. ABR (Auditory Brainstem Response). - Newborn hearing screening equipment that provides information about the auditory pathway up to the brainstem.
3.2. Advisory Committee. -- The West Virginia Hearing Impairment Testing Advisory Committee created in W. Va. Code '16-22A-4 to advise the director regarding the protocol, validity, monitoring and cost of newborn hearing screening procedures required under W. Va. Code '16-22A-1 et seq.
3.3. Birth Score Developmental Risk Screen. -- Medical assessment conducted immediately after birth to identify newborns at greatest risk for poor health or infant mortality within the first year of life, under the provisions of W. Va. Code '16-22B-1 et seq.
3.4. Director. -- The director of the division of health or his or her lawful designee.
3.5. Division. -- The division of health.
3.6. DRG (Diagnosis Related Group). -- The payment code incorporating a group of inpatient hospital charges or costs.
3.7. Health Care Facility. -- Any licensed medical facility that offers birthing services.
3.8. Health Care Provider. -- A physician or licensed midwife present during or immediately after delivery.
3.9. Primary Care Provider. -- The physician, physician=s assistant, nurse, nurse practitioner or other licensed medical professional responsible for the infant=s health services after discharge from the health care facility.
3.10. OAE (Otoacoustic Emissions Test). -- A screen that provides data about hearing distortion to the cochlea.
W. Va. Code R. § 64-24-4 When Screening is Required
4.1. W. Va. Code '16-22A-1 et seq. requires that all infants born in a licensed health care facility be screened for hearing impairments except when there is no third-party payor for the screening and the parents refuse to have the screening performed, as in W. Va. Code '16-22A-3(c).
4.2. When the birth takes place in a licensed health care facility and there is a third-party payor, the health care provider present at the birth shall immediately perform or cause to be performed screening for hearing impairments.
4.3. When an infant is born in a nonlicensed facility, including a home, the health care provider shall inform the parents of the need to obtain the screening within the first month of the infant=s life.
W. Va. Code R. § 64-24-5 Screening Protocol
5.1. The health care provider shall perform, or cause to be performed, newborn hearing screening in both ears shortly after birth, using either the ABR and/or OAE screening equipment, following the equipment manufacturer=s guidelines.
5.2. The screening shall be performed by trained personnel, according to the American Academy of Pediatrics (AAP) standards.
5.3. The director, with concurrence of the advisory committee, may update or modify the screening procedures according to screening protocol, technology and current national standards.
5.4. If the health care provider is unable to screen the infant before discharge, the primary care provider is responsible for referring the infant for a non-hospital-administered hearing screening test.
5.5. If the infant does not pass the initial screening test, the health care provider shall perform a second screening test prior to the infant=s hospital discharge.
W. Va. Code R. § 64-24-6 Screening Fee Schedule
6.1. All licensed health care facilities shall charge a fee for the initial newborn hearing screening that will be applied to all payors at a rate not to exceed the rate established by the Medicaid DRG process.
6.2. For infants born in a nonlicensed health care facility, including a home, a health care provider shall charge a fee for an outpatient newborn hearing screen at a rate not to exceed the rate established by Medicaid.
6.3. The fee for newborn hearing screening may be reviewed annually.
W. Va. Code R. § 64-24-7 Screening Reporting and Referral
7.1. The health care provider shall record the hearing screening results in the infant=s medical record and on the Birth Score Developmental Risk Screen.
7.2. The health care provider shall report all screening results to the infant=s parents, legal guardian, and primary care provider prior to discharge.
7.3. When an infant is born in a non-licensed facility, including a home, the provisions of subsection 4.3 apply.
7.4. All birthing facilities are responsible for reporting screening results. They shall send hard copy data on in-patient screening results to the Birth Score Office, West Virginia University Department of Pediatrics, P.O. Box 9214, Morgantown, WV 26506-9214.
7.5. If an infant fails the initial and second screening test in one or both ears, the health care provider shall inform the infant=s parents, legal guardian, and primary care provider.
7.6. The primary care provider shall arrange for diagnostic testing with local audiological testing facility.
W. Va. Code R. § 64-24-8 Confidentiality
8.1. Any person who obtains confidential information while implementing W. Va. Code '16-22A-1et seq. may disclose it only to reporting sources, persons demonstrating a need that is essential to health related research or care of the infant, or as required by law.
8.2. Any person who obtains confidential information while implementing W.Va. Code '16-22A-1 et seq. shall provide a written statement of confidentiality stating that he or she fully understands the privacy of the information and will maintain it.
W. Va. Code R. § 64-24-9 Penalties
9.1. Any person who violates the provisions of W. Va. Code '16-22A-1 et seq. or this rule is subject to the penalties provided in W. Va. Code '16-1-18.
64CSR24
Series 25 Certification Of Backflow Prevention Assembly Testers
W. Va. Code R. § 64-25-1 General
1.1. Scope. -- This legislative rule governs the examination and certification of backflow prevention assembly testers. The W. Va. Code is available in public libraries and on the Legislature’s web page: http://www.legis.state.wv.us/.
1.2. Authority. -- W. Va. Code §§16-1-4, 16-1-9 and 16-1-9a.
1.3. Filing Date. -- April 29, 2004.
1.4. Effective Date. -- April 29, 2004.
W. Va. Code R. § 64-25-2 Application and Enforcement
2.1. Application. -- This rule applies to certified backflow prevention assembly testers as defined in Section 3 of this rule.
2.2. Enforcement. -- This rule is enforced by the Commissioner of the Bureau for Public Health or his or her designee.
W. Va. Code R. § 64-25-3 Definitions
3.1. Applicant. -- An individual who has applied for certification as a backflow prevention assembly tester.
3.2. Approved. -- Accepted by the Commissioner.
3.3. Backflow Prevention Assembly Tester Certification. -- a written document issued by the Commissioner certifying an individual as a tester for backflow prevention assemblies.
3.4. Certified Backflow Prevention Assembly Tester. -- An individual who meets all of the requirements under this rule to be certified to inspect and test backflow prevention assemblies or methods.
3.5. Commissioner. -- Commissioner of the West Virginia Bureau for Public Health or his or her designee.
W. Va. Code R. § 64-25-4 Qualifications for Certification
4.1. Applicants for certification as a backflow prevention assembly tester shall:
4.1.a. Be a minimum of eighteen (18) years of age;
4.1.b. Have either a high school diploma or general education diploma (GED); and
4.1.c. Either:
4.1.c.1. Complete and pass all parts of an approved forty (40) hour course of instruction in theory, design, performance, testing and maintenance of backflow prevention assemblies; or
4.1.c.2. Meet re-certification, reinstatement or reciprocity requirements as provided in sections 7 or 8 of this rule.
W. Va. Code R. § 64-25-5 Certification Application
5.1. Application.
5.1.a. An applicant for certification as a backflow prevention assembly tester shall submit an application (Form EW-75, available from the Bureau for Public Health), proof of education and proof of completing an approved course of instruction as identified in Section 4 of this rule.
5.1.b. Any applicant who commits fraud or misrepresentation on the application will be permanently disqualified from consideration.
W. Va. Code R. § 64-25-6 Certification Examinations
6.1. The Commissioner shall schedule the two part (written and performance) examination for those applicants who meet the requirements in Section 4 of this rule and shall notify the applicants at least fourteen (14) days before the scheduled examination date.
6.2. The examinations shall consist of a performance examination and a closed book written examination. Exceptions to the written part are:
6.2.a. An applicant may make written request to the director at least thirty (30) days before a scheduled examination date for an oral examination to be given instead of the written examination;
6.2.a.1. Before an oral examination will be given, an applicant shall obtain written approval from the Commissioner; and
6.2.a.2. The taking of an oral examination shall not affect the performance examination requirement.
6.2.b. All examinations shall be administered in English.
6.3. Examination grade.
6.3.a. An applicant’s certification status shall be determined by the examination grade.
6.3.b. To pass the examination, an applicant is required to make a minimum grade of seventy percent (70%) on the written examination, and must demonstrate competence to the Commissioner on the performance examination.
6.3.c. An applicant who does not receive a passing grade on the written or successfully complete the performance examination shall wait a minimum of sixty (60) days before applying for reexamination.
6.3.d. An applicant who fails an examination three (3) times shall wait a minimum of one (1) year before reexamination.
6.4. Ineligible Applicants:
6.4.a. The Commissioner shall declare the examination scores of any applicant who corrupts or attempts to corrupt the examination process invalid and shall declare the applicant ineligible for certification upon discovery of the applicant’s conduct.
6.4.b. Conduct resulting in invalidation of the examination includes:
6.4.b.1. Any action that violates the security of examination materials, such as removal of any examination materials from the examination room;
6.4.b.2. Communicating with any other examinee or permitting one’s answers to be copied by another examinee; or
6.4.b.3. Falsifying or misrepresenting information for admission to the examination, impersonating an examinee or having someone else take the licensing examination on one’s own behalf.
W. Va. Code R. § 64-25-7 Certification Expiration, Re-certification, Revocation and Reinstatement
7.1. Expiration. Backflow prevention assembly tester certifications expire three (3) years after the date of issue.
7.2. For re-certification:
7.2.a. Backflow prevention assembly testers shall submit a written application (Form EW-75, available from the Bureau for Public Health) to the Commissioner at least thirty (30) days before and no more than ninety (90) days prior to expiration of current certification and the application shall include documentation, satisfactory to the Commissioner, that the applicant has sufficient experience or has attended one or more approved continuing education courses for backflow prevention assembly testers during the past three (3) years.
7.2.b. Testers who fail to submit an application for re-certification or submit an incomplete application within the time period stated in Subdivision 7.2.a. of this rule shall retake and pass both the written and performance examinations in accordance with Section 6 of this rule before the applicant will be re-certified.
7.3. Revocation or suspension. The Commissioner may revoke or suspend the certificate of any person who fraudulently obtains certification, or is found to have committed neglect, incompetency or misconduct in the performance of his or her duties as a backflow prevention assembly tester, including non-compliance with this rule. Any person whose certificate is suspended must cease any inspection and testing of backflow prevention assemblies until their certification is reinstated.
7.4. Reinstatement. The Commissioner may reinstate any person whose certification has been revoked upon being presented with satisfactory evidence that all deficiencies leading to the revocation have been corrected.
W. Va. Code R. § 64-25-8 Reciprocity
8.1. The Commissioner may grant West Virginia certification to a backflow prevention assembly tester certified by another jurisdiction, if written proof is presented to the Commissioner that:
8.1.a. The applicant has successfully passed a certification examination at least equivalent to that required under this rule;
8.1.b. The applicant has successfully completed a course of instruction at least equivalent to that required under this rule; and
8.1.c. The applicant meets the educational and age requirements of this rule.
W. Va. Code R. § 64-25-9 Compliance and Penalties
9.1. A person subject to the provisions of this rule shall comply fully with them and shall not direct or assist another person to violate this rule.
9.2. A person who violates any provision of this rule is subject to the criminal penalties of West Virginia Code §16-1-18.
W. Va. Code R. § 64-25-10 Administrative Due Process
10.1. Those persons adversely affected by the enforcement of this rule may request a contested case hearing in accordance with the Division of Health rule, “Rules and Procedures for Contested Case Hearing and Declaratory Rulings,” 64CSR1.
64CSR25
64CSR25
Series 26 Procedures Pertaining to the Dangerousness Assessment Advisory Board
W. Va. Code R. § 64-26-1 General
1.1. Scope. -- This rule explains the responsibilities and administration of the Dangerousness Assessment Advisory Board.
1.2. Authority. -- W. Va. Code §27-6A-2(h) and §27-6A-13.
1.3. Filing Date. – March 30, 2023.
1.4. Effective Date. – April 1, 2023.
1.5. Sunset Provision. -- This rule shall terminate and have no further force or effect on August 1, 2028.
W. Va. Code R. § 64-26-2 Application and Enforcement
2.1. Application. -- This rule applies to the Dangerousness Assessment Advisory Board and the review and consideration of referrals from circuit courts to the board.
2.2. Enforcement. -- This rule is enforced by the Office of Health Facilities, Department of Health and Human Resources, in consultation with the chairperson of the board.
W. Va. Code R. § 64-26-3 Definitions
3.1. Administrator. -- The person selected by the chairperson of the board to oversee the administrative affairs of the board and to facilitate the operation of the board to promote the provision of objective expertise to circuit court judges.
3.2. Board. -- The Dangerousness Assessment Advisory Board created pursuant to W. Va. Code §27-6A-13 to provide opinion, guidance, and informed objective expertise to circuit courts as to the appropriate level of custody or supervision necessary to ensure that persons who have been judicially determined to be incompetent to stand trial and not restorable or not guilty by reason of mental illness are in the least restrictive environment available to protect the person, other persons and the public generally.
3.3. Case Referral. -- A written request by a circuit court judge by order or other writing that seeks opinion, guidance, or objective expertise from the board regarding the proposed placement plan or the proposed less restrictive placement of a forensic patient.
3.4. Chairperson -- The person nominated by the board at which a quorum is present and who is a board-certified forensic psychiatrist as defined by W. Va. Code §27-6A-13(a)(6) or a forensic psychologist as defined by W. Va. Code §27-6A-13(a)(7).
3.5. Evaluation. -- A forensic competency evaluation, forensic criminal responsibility evaluation, dangerousness risk assessment, or any forensic evaluation of a forensic patient.
3.6. Forensic Placement Audit. -- When considering case referrals or providing guidance otherwise requested by circuit court judges, the board may identify placement obstacles or barriers and develop one or more recommendations for review and consideration by the secretary, the court, or the Legislative Oversight Commission on Health and Human Resources Accountability to potentially redress such obstacles or barriers and to promote appropriate less restrictive placements.
3.7. Forensic Patient. -- A person who has been found incompetent to stand trial and not restorable or not guilty by reason of mental illness in accordance with W. Va. Code §27-6A-1 et seq. and who has been committed to or ordered to be placed at a mental health facility, jail, correctional facility, or other location. Forensic patients may also include juveniles subject to W. Va. Code §49-4-727 et al.
3.8. Medical Director. -- The chief medical officer of William R. Sharpe, Jr., Hospital as defined by W. Va. Code §27-1-13 who convenes a meeting of the board in accordance with W. Va. Code §27-6A-13(c).
3.9. Mental Health Facility. -- A mental health facility as defined by W. Va. Code §27-1-9.
3.10. Secretary. -- The secretary of the Department of Health and Human Resources.
W. Va. Code R. § 64-26-4 Severability
4.1. Severability. -- If any sections or subsections of this rule are determined to be invalid, it shall not be construed to invalidate any of the provisions not otherwise affected.
W. Va. Code R. § 64-26-5 Conduct of Dangerousness Assessment Advisory Board
5.1. Duties. The board shall review case referrals and other requests made to it and provide informed and objective recommendations regarding such case referrals or requests in accordance with W. Va. Code §27-6A-13(b). In its discretion, the board may perform a forensic placement audit in connection with any case referral to promote the purpose of the board and to promote appropriate placements in less restrictive settings.
5.2. Chairperson. The board shall elect a chairperson who shall preside at all regular or special meetings of the board. In the absence of the chairperson, the chairperson shall designate a board member to preside at any meeting of the board. The chairperson shall have the following specific duties: (a) call and conduct all board meetings; (b) participate in planning agendas for board meetings; (c) speak as the official representative of the board; (d) designate members of the board or the administrator to appear on the board’s behalf before the West Virginia Legislature or at other forums; and (e) supervise the duties of the administrator.
5.3. Administrator. The administrator will be the primary point of contact for board members on administrative matters and operations of the board.
5.4. Regular Meetings. The board shall convene at least once each month to review pending case referrals and make recommendations regarding case referrals. A quorum consists of six members, two of whom must meet the criteria of W. Va. Code §27-6A-13(a)(6) and §27-6A-13(a)(7). Meeting location will be determined by the administrator in consultation with the chairperson and can be conducted in person or electronically via visual communication. The administrator will prepare a meeting agenda in consultation with the medical director and the board chairperson, if applicable, and provide the agenda to board members at least five days prior to a regular meeting.
5.5. Special Meetings. A special meeting at which a quorum is present may be convened at the request of the medical director; the written request of at least four members of the board to the administrator; or at the administrator’s recommendation if a circuit court makes a case referral that requires consideration prior to the board’s next regular meeting. The administrator will prepare a meeting agenda in consultation with the medical director and the board chairperson, if applicable.
5.6. Records for Case Referrals. The board shall have access to all court records and mental health records available to the circuit court and all documents consulted by the medical director or the statewide forensic clinical director regarding the treatment and potential placement of the forensic patient for whom a case referral or other request is under consideration. At a minimum, the documents of the forensic patient shall include all dangerousness risk assessments; all psychological testing or assessments at current mental health facility; the conditional release plan; all notes from community integration if applicable; all behavior notes; medical provider notes for last 90 days; medication administration list for last 90 days; placement date list (pink/orange sheet) maintained by the mental health facility; psychiatric evaluation(s); data from the START; and relevant pleadings, e.g., criminal complaint. The Forensics Department at William R. Sharpe, Jr., Hospital shall make all such documents available to board members via a secure and encrypted website.
5.7. Recommendations in Response to Case Referrals. The board shall develop its recommendations based solely on the records available as defined in subsection 5.6. The board may not conduct any adversarial, contested, or evidentiary hearings in developing its recommendations. Any recommendation by the board requires the approval of at least five board members (two of whom must meet the criteria of W. Va. Code §27-6A-13(a)(6) and §27-6A-13(a)(7)) at which a quorum is present. Recommendations by the board in response to a case referral shall be communicated to the requesting circuit court via letter by the chairperson within 10 days after any regular meeting or special meeting at which the case referral was considered. The board shall provide responsive and objective guidance to a court’s inquiry based on available clinical information and records the board shall further provide any information or recommendations to the court that the board in its independent judgment deems appropriate to assist the court with matters including, but not limited to, treatment, placement, discharge, release, community outings, custody, supervision, and barriers or obstacles to treatment, placement, discharge, release, community outings, custody, and supervision of forensic patients.
5.8. Recusal. Any member of the board who within the prior two years has performed an evaluation of a forensic patient, received remuneration as a result of an evaluation of a forensic patient, or offered or provided supervisory review or approval of an evaluation of a forensic patient under the authority of his or her professional license shall be recused from any consideration of any case referral involving such forensic patient and shall not participate in any board proceedings or discussions related to any such case referral. Notwithstanding anything herein to the contrary, the board in consultation with the board’s counsel may determine that recusal is unnecessary based on the peculiar circumstances of the case referral, the disclosures of the board member, or the nature of the prior evaluation.
5.9. Mail. The Office of Health Facilities, West Virginia Department of Health and Human Resources, located at 100 Dee Drive, Charleston, West Virginia 25311, shall be responsible for the receipt of all correspondence and case referrals from the courts. The Office of Health Facilities shall provide copies of all correspondence and case referrals promptly to the chairperson and the administrator.
W. Va. Code R. § 64-26-6 Confidentiality
6.1. Subject to case referral recommendations required by section 5.7. of this rule, all proceedings and communications of the board and opinions expressed by members of the board and the administrator are confidential, not subject to subpoena, and not subject to public disclosure or dissemination. The provisions of W. Va. Code §6-9A-1 et seq. and W. Va. Code §29B-1-1 et seq. are inapplicable to the board and the board’s operations.
W. Va. Code R. § 64-26-7 Immunity
7.1. Members of the board shall be immune from suit and liability, either personally or in their official capacity, for any claim for damage to or loss of property or personal injury or other civil liability caused or arising out of any actual or alleged act, error, or omission that occurred within the scope of their duties or responsibilities on the board: Provided, That nothing in this subsection shall be construed to protect any person from suit or liability, or both, for any damage, loss, injury, or liability caused by the intentional or willful and wanton misconduct of that person or a board member who fails to recuse herself or himself from participating in any case referral as required by subsection 5.8.
W. Va. Code R. § 64-26-8 Compensation
8.1. Each board member whose regular salary is not paid by the State of West Virginia shall be paid the same compensation and expense reimbursement that is paid to members of the Legislature for their interim duties as recommended by the Citizens Legislative Compensation Commission and authorized by law for each day or portion thereof engaged in the discharge of official duties. Reimbursement for expenses shall not be made, except upon an itemized account, properly certified by the members of the board. All reimbursement for expenses shall be paid out of the State Treasury upon a requisition upon the State Auditor.
64CSR26
64CSR26
Series 27 Statewide Trauma and Emergency Care System
W. Va. Code R. § 64-27-1 General
1.1. Scope. -- This legislative rule establishes the standards, criteria, and methods for designating various health care facilities in the State of West Virginia as meeting specific levels of care capability as trauma and emergency care centers or facilities in order to identify those facilities best equipped and staffed to care for patients experiencing emergency injuries or illnesses. It also establishes the responsibilities, powers, and authority of certain trauma / emergency medical services committees or councils and establishes the organizational structure of a statewide trauma / emergency care system including medical review committees for system quality. This rule should be read in conjunction with W. Va. Code §16-4C-1 et seq. and §55-7B-9c.
1.2. Authority. -- W. Va. Code §16-1-4, §16-4C-23, and §55-7B-9c(k).
1.3. Filing Date. -- May 8, 2025.
1.4. Effective Date. -- July 1, 2025.
1.5. Sunset Provision. -- This rule shall terminate and have no further force or effect on August 1, 2030.
W. Va. Code R. § 64-27-2 Application and Enforcement
2.1. Application. -- This rule applies to all health care institutions, facilities, hospitals, clinics, agencies, corporations, partnerships, and governmental agencies engaged in the provision of emergency care to injured or ill patients in the state.
2.2. Enforcement. -- This rule is enforced by the Secretary of the Department of Health.
W. Va. Code R. § 64-27-3 Definitions
3.1. American College of Surgeons, Committee on Trauma Guidelines (ACS-COT) -- The guidelines published by the American College of Surgeons, Committee on Trauma, outlining the listing of resources for optimal care of the injured patient entitled “Resources for Optimal Care of the Injured Patient”.
3.2. Categorization Process -- The process through which the Office of Emergency Medical Services (OEMS) determines the level of care capability of emergency facilities in various categories of emergency care to assist medical command in determining the most appropriate facility to which an emergency patient should be transported.
3.3. Designated Facility -- A facility that has been officially designated as a West Virginia trauma center by the Department through the OEMS.
3.4. Designation -- An official notification by the Secretary to a particular health care facility indicating the level of trauma care capability determined through the verification process.
3.5. Emergency Medical Services (EMS) -- Emergency medical services as defined in W. Va. Code §16-4C-3(d).
3.6. Emergency Medical Services Advisory Council (EMSAC) -- The Emergency Medical Services Advisory Council created pursuant to W. Va. Code §16-4C-5.
3.7. Medical Policy and Care Committee (MPCC) -- The committees established by OEMS at the regional and state levels as outlined in “Emergency Medical Services”, 64CSR48, that serve as the primary advisory committees to the regional and state EMS medical director on all medical issues involving the EMS System.
3.8. Medical Review Committees (MRC) -- The committees established by OEMS at the local, regional, and state levels to provide medical peer review and quality assurance for the state trauma and emergency care system.
3.9. Office of Emergency Medical Services (OEMS) -- The Office of Emergency Medical Services within the Department.
3.10. OEMS Medical Direction System -- The system established within OEMS that has the primary responsibility for the establishment of the policies and procedures governing all aspects of the operation of the online and off-line medical direction for all EMS activities in West Virginia. This system includes, but is not limited to, state, regional, and agency medical directors, committees, and medical command centers.
3.11. Revocation of Designation -- The removal of designation from a health care facility requiring the complete re-application process before designation can be reinstated.
3.12. Secretary -- The Secretary of the West Virginia Department of Health.
3.13. State Trauma Advisory Council (STAC) -- The primary advisory council to the state EMS medical director and OEMS on all trauma- related matters.
3.14. State Trauma Registry -- The information system maintained by OEMS to collect and maintain the necessary trauma and emergency care information to assure system quality and accountability, as well as to provide data for use in system design and operations. This system includes, but is not limited to, the State Trauma Registry (STR), the State Medical Command Record (SMCR), and the EMS Patient Care Record (EPCR).
3.15. Suspension of Designation -- The temporary removal of designation from a health care facility pending further review and evaluation by the Commissioner.
W. Va. Code R. § 64-27-4 Powers of Designation and Categorization
4.1. The Department through OEMS has the power to designate healthcare facilities in the state that meet the criteria set forth in this rule. The Secretary shall provide a designation in writing to the health care facility upon determination that the standards and criteria for that designation have been met. Facilities designated as trauma centers shall enjoy all of the rights and privileges provided by the West Virginia Code and this rule including limits of liability pursuant to W. Va. Code §55-7B-9c.
4.2. An institution, health care facility, unit, center, or hospital shall not represent itself as a trauma center, unit, or facility until a designation level is assigned by the Secretary. Any public advertisement or claim of trauma care capability by a facility prior to receiving the appropriate designation may result in the initiation of civil proceedings against the institution or facility.
4.3. Any institution, health care facility, unit, center, or hospital that received designation as a trauma center from the Secretary is exempt from the antitrust laws of-this state pertaining to antitrust actions brought as a result of the designation by an individual, individuals, corporation, partnership, other health care institution, or governmental agency.
W. Va. Code R. § 64-27-5 Types of Designation
5.1. General. The Department shall use the following general categories when granting trauma center designation status to facilities:
5.1.1. Permanent, when a facility meets all the requirements as referenced in this rule. Permanent designation may be granted for a maximum of three years.
5.1.2. Provisional, when a facility substantially meets the requirements and has outlined in writing clear plans and progress toward full compliance with all requirements. Provisional designations may be granted for not less than six months nor longer than two years with a possible extension of six months.
5.1.3. Probational, when the Secretary determines that it is in the best interest of the public health and safety for a permanently designated facility to remain designated while identified non- compliance issues are being corrected. The facility shall provide written evidence of active progress in correction of non-compliance areas. Probational designation may be granted for not less than six months nor longer than two years, with a possible extension at the discretion of the Secretary.
5.1.4. Emergency, when the Secretary determines that it is in the best interest of public health and safety to temporarily designate a facility to meet a particular emergency need. Emergency designation shall not exceed six months, with a possible extension of six months at the discretion of the Secretary.
5.2. Levels. The standards and criteria for designation as a West Virginia trauma center are those standards outlined in “Resources for Optimal Care of the Injured Patient”, by the ACS-COT with variations as outlined in this subsection. The following levels of care designations will be used when granting trauma center designation status to facilities:
5.2.1. Level I. The facility meets, at a minimum, the ACS-COT standards for a level I center as determined by OEMS.
5.2.2. Level II. The facility meets, at a minimum, the ACS-COT standards for a level II center as determined by OEMS.
5.2.3. Level III. The facility meets, at a minimum, the ACS-COT standards for a level III center as determined by OEMS.
5.2.4. Level IV. The facility meets, at a minimum, the ACS-COT standards for a level IV center as determined by OEMS.
W. Va. Code R. § 64-27-6 Criteria for Designation
6.1. The standards and criteria for designation as a West Virginia trauma center are those standards outlined in “Resources for Optimal Care of the Injured Patient”, by the ACS-COT with specific modifications or additions set forth in Subsection 6.2 of this rule.
6.2. Facilities at all levels shall meet and maintain the following additional specific requirements in order to be designated and maintained as a West Virginia trauma center. The facilities shall:
6.2.1. Participate and submit information to the State Trauma Registry (STR);
6.2.2. Meet all benchmarks of timely submission of data and information into the STR as established by OEMS;
6.2.3. Actively participate in the state trauma and emergency care performance improvement and medical review process as outlined in section 10 of this rule;
6.2.4. Provide and maintain appropriate hardware and software. This includes internet access to the OEMS central site;
6.2.5. Actively participate and abide by medical command guidelines including adherence to all policies and procedures established which govern the statewide facility resource tracking mechanisms as established by the OEMS Medical Direction System;
6.2.6. Provide facility representatives to all required committees of the statewide trauma emergency care system as outlined by OEMS and assure that appropriate attendance is maintained;
6.2.7. Maintain compliance with state and federal laws, rules, and regulations concerning confidentiality of patient information and participation in the medical review process;
6.2.8. Maintain written trauma team policies and procedures, including activation guidelines and operational guidelines for all members of the trauma team including physicians, nurses, EMS personnel, and other ancillary staff. At no time may a trauma team member exceed the scope of practice established by his or her respective certifying or licensing authority; and
6.2.9. Participate and abide by all policies and procedures of the statewide trauma and emergency care system including the facility categorization guidelines in section 8 of this rule.
W. Va. Code R. § 64-27-7 Process of Designation
7.1. The chief executive officer of a facility seeking to apply for trauma center designation shall request in writing from the medical director of OEMS an application for initial provisional trauma center designation. The application and other required materials shall be completed and submitted to OEMS with the initial provisional non-refundable designation fee.
7.2. Site visits. The following two types of site visits are used in the designation process:
7.2.1. Consultation site visit. A consultation site visit shall be conducted early in the provisional designation process to identify areas of noncompliance and provide specific recommendations to assist facilities in fully meeting the designation requirements.
7.2.1.a. All facilities seeking designation as a level I, II, or III center shall obtain an official ACS-COT consultation site visit as outlined in Subdivision 7.3.3. of this rule, except as provided in Subdivision 7.3.8. of this rule. OEMS may waive this consultation site visit if the facility has undergone an official ACS-COT consultation site visit in the past year.
7.2.1.b. All facilities seeking designation as a level IV center shall obtain a consultation site visit by a site visit team as outlined in Subdivision 7.3.3. of this rule.
7.2.1.c. The team composition, format, and nature of a level IV consultation shall be determined by OEMS based on discussions and information from the specific facility as to the need for clarification of guidelines and degree of assistance needed to meet the standards and criteria of designation. In certain situations, the consultation may be done by telecommunications or other electronic or written means.
7.2.2. Verification site visit. A verification site visit shall be conducted during the provisional designation period or prior to re-certification of a permanently designated facility, in order to verify compliance with trauma center designation requirements.
7.2.2.a. All facilities seeking permanent designation as a level I, Il, or I center shall obtain an official ACS-COT verification site visit as outlined in Subdivision 7.4.2. of this rule, except as provided in Subdivision 7.3.8. of this rule.
7.2.2.b. All facilities seeking designation as a level IV center shall obtain a verification site visit by a site visit team as outlined in Subdivision 7.4.3. of this rule.
7.3. Initial Provisional Designation. -- Any facility seeking designation as a trauma center shall apply for initial provisional designation status as outlined in this rule. The Secretary may grant provisional status to facilities which meet or substantially meet the requirements as outlined in this rule and provide evidence of committed progress toward meeting all standards and criteria for permanent designation status. The process for obtaining provisional designation and required activities during the provisional designation are as follows:
7.3.1. Upon receiving a correctly completed application and other required materials, OEMS shall review and evaluate the information provided and make a preliminary assessment as to the facility's ability to meet the requirements of the designation level requested. If, in the opinion of OEMS, the facility appears to substantially meet the requirements and shows evidence of committed progress toward meeting all standards and criteria for permanent status, the facility will be notified in writing of the intent to-grant provisional designation status to the facility.
7.3.2. If OEMS determines that the facility does not have the ability to substantially meet the requirements for provisional designation at the requested level, OEMS shall deny the application and may recommend that the facility seek provisional designation at a different level and/or suggest to the facility additional modifications before re-applying for provisional designation status.
7.3.3. Upon receiving notification from OEMS of the intent to grant provisional status, the facility shall provide to OEMS evidence of the scheduling of a consultation site visit as outlined in Subsection 7.2. of this rule to occur within 90 days of-the notification except as outlined in Subsection 7.2.1.a. of this rule. The cost of the consultation site visit is at the facility's own expense.
7.3.4. After receiving written evidence from the facility of the scheduled consultation site visit, the Secretary shall grant the facility official provisional designation status. The provisional designation letter shall outline any known non-compliance areas discovered during the preliminary review conducted under Subdivision 7.3.1. of this rule. OEMS may establish specific time frames for correction of deficiencies or other activities, including expected progress toward complete compliance. Facilities shall respond to all inquiries and requirements as outlined by OEMS. Provisional status remains valid for no longer than two years, except as outlined in Subdivision 7.3.5. of this rule.
7.3.5. The Secretary may grant a facility a one-time only six month extension of provisional status, upon submission by the facility of a written request for extension, accompanied by a detailed explanation and plan of action to fulfill the requirements for permanent trauma center designation. If, at the end of the six month extension period, the facility has not been designated as a permanent trauma center, the provisional designation expires.
7.3.6. Facilities shall use the information provided in the consultation site visit report to assist in correction of noncompliance areas in preparation for the permanent verification site visit. Facilities shall send OEMS a written copy of the consultation report within 10 days of receipt of the report by the facility.
7.3.7. Provisionally designated facilities seeking permanent designation shall complete the permanent designation process as outlined in Subsection 7.4. of this rule, no sooner than six months nor longer than two years after the date of official provisional designation.
7.3.8. If a facility applying for initial provisional designation status has a valid ACS-COT verification certificate issued within the previous two years, OEMS may waive the requirement for a consultation site visit and grant the facility provisional designation status. The facility may then apply for permanent designation status by completing the permanent designation application and materials and paying the appropriate permanent designation fee. If after six months of provisional status the facility continues to meet or exceed all standards and criteria established in this rule, the Secretary may waive the requirement for a verification site visit and grant the facility permanent designation as outlined under the permanent designation guidelines in Subsection 7.4. of this rule.
7.4. Permanent designation. Provisional centers seeking permanent designation shall complete the following process during their provisional designation period no sooner than six months nor greater than two years after their official date of provisional designation:
7.4.1. All facilities seeking permanent designation shall complete and submit an official permanent designation application and other required materials to OEMS, along with the non-refundable permanent designation fee. This permanent designation application shall be submitted 90 days prior to expiration and prior to the scheduling of the verification site visit.
7.4.2. All facilities seeking permanent designation as a level I, II, or III center shall obtain an official ACS-COT verification site visit. This visit shall be conducted no later than two years after the granting of provisional designation, except as outlined in Subdivision 7.3.8. of this rule. The cost of the ACS-COT verification site visit is at the facility’s own expense.
7.4.3. All facilities seeking designation as a level IV center shall obtain a verification site visit by a site visit team. This visit shall be conducted no later than two years after the official provisional designation date. The verification site visit team shall be appointed by the state EMS medical director from a pool of names developed by the STAC. The site visit team shall consist of a minimum of two persons, one of which is a licensed physician who practices in emergency medicine or trauma surgery and one who is a registered nurse with trauma system care experience. The credentials of this pool shall be developed by the STAC.
7.4.4. Verification site visit reports shall be sent to the medical director of OEMS. The facilities shall ensure that ACS-COT site visit reports are received by OEMS within 10 days of receipt of the report by the facility. In extreme situations where a delay in receipt of a report is beyond the control of the facility, OEMS may accept the report if the circumstances for a reasonable delay are explained in writing. State site visit reports shall be sent by the site visit team to the medical director of OEMS in a timely manner.
7.4.5. OEMS shall use the information from the verification site visit report and other information, including activities during the facility's provisional status, to determine the permanent designation status of the facility. OEMS may take into account any special situations relating to the state system when rendering a final decision including, but not limited to: the need for trauma or emergency care in a particular geographic area; the number of facilities applying for designation within a particular locale or area; and resources available within a specific area. OEMS may require facilities to develop joint facility designation plans according to specific guidelines established by OEMS in situations where multiple facilities are seeking similar designation status in the same general location. Nothing in this rule shall be interpreted to require OEMS or the Secretary to designate or not designate a facility based solely on the recommendation of the verification site visit report.
7.4.6. OEMS may visit the facility or make further inquiries to confirm information in the application or site visit report in order to determine the final disposition of the facility.
7.5. Granting of designation.
7.5.1. The Secretary shall review the site visit report, application, and any additional materials and, within 30 days after receipt of the site visit report, shall determine the designation status of the facility.
7.5.2. The Secretary shall issue the official designation letter and certification to the facility.
7.6. Authority to inspect. Any facility designated or seeking designation may be inspected at any time by OEMS in order to determine compliance with the standards and criteria outlined in this rule.
7.6.1. Facilities shall make available any requested information and cooperate fully with OEMS during a compliance inspection. Failure to cooperate as determined by OEMS shall be grounds for immediate suspension of designation status pending further review and investigation.
7.6.2. If information obtained during an inspection visit indicates substantial non-compliance with standards or criteria, OEMS shall provide written notification to the facility of its intent to change the designation status of the facility. This written notification shall include detailed descriptions of the areas of non-compliance as well as the proposed action by OEMS concerning the designation status of the facility.
7.6.3. If the facility disagrees with the findings outlined in the notification referenced in Subdivision 7.6.2. of this rule, the facility may respond in writing to the state EMS medical director, within 10 working days, and present evidence as to why the facility is not subject to the proposed action. Specific steps proposed to correct the deficiencies shall also be included. The Secretary shall consider this information and make a decision within 30 days of receipt of the facility’s written response and shall send written notification to the facility of the decision regarding the request and the final status of the facility. If the Secretary’s decision is unfavorable, the facility may then request a contested case hearing pursuant to Section 1 of this rule.
7.6.4. If information is obtained by inspection or other means that OEMS concludes identifies a situation or condition at a facility that could pose an immediate threat to the public health or safety, the OEMS medical director may immediately suspend the designation status of a facility pending further review and evaluation by the Secretary.
7.7. Designation Fees. Pursuant to W. Va. Code §55-7b-9c(m)(2), OEMS may collect reasonable fees for designation of trauma centers.
7.7.1. Fees for designation:
7.7.1.a. Shall accompany the application for initial provisional designation, the application for permanent designation, and the application for re-certification of permanent designation;
7.7.1.b. Shall be the following: initial provisional designation fee per facility, $2000; permanent designation fee, $2000; level I, II, and III re- certification designation fee, $5000; and level IV re-certification designation fee, $2500; and
7.7.1.c. Are non-refundable and shall be deposited in accordance with W. Va. Code §16-4C- 6b and expended in accordance with the duties imposed in this rule.
7.8. Re-certification of Designation Status. Permanent designation status is valid for three years from the date identified in the official permanent designation letter from the Secretary.
7.8.1. Within the last year of certification, all level I, II, and I trauma facilities shall undergo an ACS-COT verification site visit and file the report of that visit with a re-certification application supplied by OEMS. The application and site visit report shall be submitted to OEMS with the appropriate non- refundable designation fee, no less than 90 days prior to the expiration of the designation certification of the facility.
7.8.2. Within the last year of certification, all level IV trauma facilities shall undergo a re- verification site visit by a site visit team. The facility shall schedule the visit with OEMS so as to ensure its completion no less than 90 days prior to the expiration of the designation certification of the facility. The re-certification application, materials, and appropriate non-refundable designation fee must be received by OEMS prior to scheduling of the site visit.
7.8.3. OEMS may grant an extension of the re-certification time limits of up to 120 days if the facility submits in writing clear and convincing evidence of extraordinary circumstances which prevent the completion of the re-certification process on schedule.
7.9. Probational Designation. The Secretary may place a permanently designated facility on probational status if it is determined to be in the best interest of the public health and safety for the facility to remain designated during the time it is in the process of correcting deficiencies identified by OEMS either during the re-certification process or during an inspection of the facility.
7.9.1. In the event that a facility is placed on probational status, OEMS shall provide written notification to the facility outlining the specific deficiencies requiring correction. OEMS may at its discretion establish time frames for correction of deficiencies or other activities.
7.9.2. If a facility does not meet the standards and criteria for permanent designation within a reasonable time, but not less than one year, the facility designation may continue on probation, be changed to provisional, be downgraded, or revoked.
7.9.3. A facility whose designation has been revoked may reapply for designation and complete all the requirements outlined in this rule. Facilities may not reapply sooner than one year after the date of official revocation.
7.10. Downgrading, Suspension, or Revocation of Designation. A facility's designation status may be downgraded, placed on probation, suspended, or revoked at any time by the Secretary for failure of the facility to substantially comply with any of the standards and criteria outlined in this rule. The Secretary may also downgrade, place on probation, suspend, or revoke the designation status of a facility any time continued designation poses a threat to the public health or safety, as determined by the Secretary.
7.10.1. In the event a facility's designation is downgraded, suspended, or revoked, OEMS shall provide written notification to the facility outlining the specific reasons for the action.
7.10.2. If a facility disagrees with the findings leading to the action taken under Subdivision 7.10.1. of this rule, it may respond as outlined in Subdivision 7.6.3. of this rule.
W. Va. Code R. § 64-27-8 Categorization of Facilities for Emergency Care Capabilities
8.1. Pursuant to W. Va. Code §16-4C-18, emergency medical services personnel under the direction of medical command shall determine the appropriate facility to which a patient shall be transported. In order to provide the necessary information to medical command, OEMS may develop and implement policies and procedures to categorize the emergency care capability of all facilities receiving emergency medical patients.
8.2. Specific Categories of Care. OEMS may require facilities applying for designation as a trauma center to provide additional information in order to determine the categorization of level of care capability of the facility in other areas of emergency care including, but not limited to, cardiac care, general emergency care, stroke and neurological conditions, pediatric emergencies, burns, psychiatric emergencies, respiratory conditions, poisoning and toxicology, and obstetrics and gynecology.
8.3. Guidelines for Categorization Process. Policies and procedures for the process, criteria for categories of care, and level of care capabilities shall be developed by the State MPCC, pursuant to “Emergency Medical Services”, 64CSR48.
8.3.1. OEMS may conduct a verification site visit to confirm the categorization information in order to determine the resources and level of care capability of a facility to assist medical command with appropriate facility destination decisions.
8.3.2. If a facility fails to cooperate and participate in the categorization process, the Secretary may revoke the facility’s trauma center designation. OEMS may enter the facility in order to accumulate necessary information to evaluate the facility's care capability.
8.3.3. Using the categorization information, the OEMS Medical Direction System shall develop triage policies and procedures for use by medical command in determining the most appropriate destination to which a patient should be transported.
8.3.4. Facilities shall notify the state EMS medical director in writing of any changes to the level of care within each category. OEMS may then obtain additional information or conduct a site visit to confirm the changes and notify the facility and medical command of any change in the categorization of a facility.
8.3.5. Facility categorization shall be updated during a facility's trauma designation re- certification process, or any time information is obtained by OEMS which may indicate a change in categorization is warranted.
W. Va. Code R. § 64-27-9 Trauma and Emergency Care System Organization and Operation
9.1. Pursuant to W. Va. Code §55-7B-9c, the organization and operation of the state trauma and emergency care system shall be integrated with the existing emergency medical services system.
9.2. The lead agency for the trauma and emergency care system is OEMS within the Department. As the lead agency for the system, OEMS shall develop and implement policies and procedures necessary to carry out the operation and management of the state trauma and emergency care system, including but not limited to: trauma center designation; facility categorization, system design, and operation; medical review and audit for performance improvement and quality assurance; and development and enforcement of triage, transfer, and emergency procedures guidelines.
9.3. The advisory councils for the trauma and emergency care system shall be the EMSAC and the STAC. Their duties are to advise OEMS and the Secretary in all matters relating to the trauma and emergency care system as follows:
9.3.1. The STAC members shall:
9.3.1.a. Include at a minimum: the Chair and Vice-chair of the West Virginia State Committee of the American College of Surgeons, Committee on Trauma (WV ACS-COT); the immediate past chair of the WV ACS-COT; the trauma medical director of-all designated level I, II, and III facilities; a physician from the West Virginia Chapter of-the American College of Emergency Physicians; a hospital administrator; an aeromedical medical director; a medical director and an additional representative of a level IV designated trauma center; a rural hospital representative; a registered nurse trauma program manager; a trauma registrar; a pediatric surgeon; a paramedic with trauma care experience; a consumer member from the general public; and other members as recommended by STAC and appointed by the state EMS medical director; and
9.3.1.b. Be appointed by the state EMS medical director from a list of potential appointees submitted by the STAC. The STAC shall solicit potential appointees from the various agencies or organizations who have representation on the STAC and then recommend appointments to the state EMS medical director from those names. A list of potential appointees for the hospital administrator and rural hospital representative may be submitted to the STAC by the West Virginia Hospital Association; and
9.3.1.c. Be appointed for a term of three years. Members may be reappointed if recommended by the STAC to the state EMS medical director;
9.3.2. The STAC shall:
9.3.2.a. Recommend procedures and guidelines for the formation and administration of a state trauma and emergency care system;
9.3.2.b. Recommend policies and procedures governing the evaluation, designation, and re- designation of state trauma centers;
9.3.2.c. Establish the credentials and serve as the central resource pool of individuals for appointment by the state EMS medical director to serve on site visit teams;
9.3.2.d. Recommend and evaluate data collection needs for quality improvement, medical review, and planning purposes for the system;
9.3.2.e. Serve as the main liaison for activities between the West Virginia Committee ACS-COT and OEMS;
9.3.2.f. Explore and seek additional funding sources to continue the development and maintenance of the state trauma and emergency care system;
9.3.2.g. Recommend policies and procedures necessary to carry out its duties; and
9.3.2.h. Undertake other duties as assigned by the OEMS director or medical director;
9.3.3. The council shall meet a minimum of twice a year.
9.4. Trauma and Emergency Care Regions. OEMS may establish policies and procedures governing the design, implementation, and operation of trauma and emergency care regions as part of the state trauma and emergency care system. The policies and procedures governing these regions shall include, but are not be limited, to: administration and support within the region; funding and operation; establishment of lead trauma hospitals; and coordination and development of funding mechanisms.
9.5. Medical Direction. The OEMS Medical Direction System shall provide medical direction for all aspects of the state trauma and emergency care system.
9.5.1. The state EMS medical director may appoint additional members to the State MPCC as may be necessary to assure proper input from specific specialists or agencies and to assure proper integration of the trauma and EMS system statewide, as required in W. Va. Code §55-7B-9c.
9.5.2. The OEMS medical direction system in conjunction with facilities supporting medical command and interested designated trauma centers shall establish a centralized resource center to coordinate and manage the resources necessary for efficient, effective, and accurate triage, transfer, and treatment of the seriously injured or ill patients in the state. The resource center shall at a minimum:
9.5.2.a. Monitor and manage a statewide tracking system of facility resources and diversion status to ensure proper patient triage and appropriate destination decisions;
9.5.2.b. Provide for the coordination of urgent and emergent inter-facility transfers of trauma and seriously ill patients within the system including aeromedical and critical care ground transport;
9.5.2.c. Coordinate the resources necessary for effective triage and transfer of injured or ill patients from the scene of an incident or from health care facilities throughout the state to the closest appropriate facility, based on established triage and transfer guidelines developed by the medical direction system;
9.5.2.d. Develop the capability to assist or provide online medical command to EMS field units as may be requested or required by OEMS medical direction system;
9.5.2.e. Assist in the collection and management of patient care information for purposes of public health operation and monitoring including the performance improvement and quality assurance medical review process as outlined section 10 of this rule;
9.5.2.f. Collaborate with health care providers, facilities, and other interested parties to identify and seek funding to support the medical command system and resource center components of the trauma and emergency care system; and
9.5.2.g. Develop policies and procedures necessary to carry out its duties.
9.5.3. The State MPCC shall develop and recommend written protocols specifying the standards for triage and emergency health care procedures for the trauma and emergency care system pursuant to W. Va. Code §55-7B-9c(g) and (h).
W. Va. Code R. § 64-27-10 Trauma and Emergency Care System Accountability
10.1. Policies and procedures. To ensure system accountability, OEMS shall develop policies and procedures governing the components necessary to collect and analyze information within the trauma and emergency care system including patient care information. These policies and procedures shall include guidelines for medical review and audit to assure system quality as required in W. Va. Code §55-7B- 90(k).
10.2. OEMS shall maintain a State Trauma Registry in order to provide the necessary information to assure system quality and accountability as well as to provide data for use in system design and operations.
10.2.1. The three major components of the system shall be the State Trauma Registry (STR), the State Medical Command Record (SCR), and the EMS Patient Care Record (EPCR). Other components may be added as needed to facilitate effective operation and management of the trauma and emergency care system.
10.2.2. All designated trauma centers, medical command centers, and licensed EMS agencies shall collect and provide information to the system as required in the policies and procedures governing the operation of the system.
10.2.3. OEMS shall ensure the security and confidentiality of protected information within the system according to state and federal guidelines. All designated trauma centers, medical command centers, and licensed EMS agencies and their personnel shall follow all policies and procedures governing the system including the confidentiality of the information submitted.
10.3. Medical Review and Quality Improvement. The medical review and quality improvement process for the trauma and emergency care system shall consist of medical review committees (MRC) at the local, regional, and state level. OEMS shall develop policies and procedures for the operation of these committees. Pursuant to WV Code §55-7B-9c these committees and the providers shall qualify for all the rights and protections established in WV Code §§30-3C-1 et seq.
10.3.1. Each designated trauma center and each licensed EMS agency shall develop a local MRC that follows guidelines established by OEMS.
10.3.2. The regional MRC shall consist of the following members:
10.3.2.a. The regional EMS medical director, who shall serve as the co-chair of the committee;
10.3.2.b. A trauma surgeon representative from each level I, II, and III designated trauma center within the region, one of which shall be elected by the regional MRC as the co-chair;
10.3.2.c. A physician representing all level IV designated trauma centers within the region. This physician will be appointed by the regional medical director from a list of nominees submitted by the centers;
10.3.2.d. Two EMS agency medical directors appointed by-the regional medical director;
10.3.2.e. Two paramedics from licensed EMS agencies within the region appointed by the regional medical director. The paramedics shall not be from the same agency as the medical directors on the committee; and
10.3.2.f. A registered nurse with trauma and emergency care experience appointed by the regional medical director.
10.3.3. The state MRC shall consist of the following members:
10.3.3.a. The state EMS medical director, who shall serve as the co-chair of the committee;
10.3.3.b. A trauma surgeon appointee from the membership of the STAC, who shall serve as the co-chair of the committee;
10.3.3.c. A regional medical director appointed by the state MPCC;
10.3.3.d. A practicing emergency physician appointed by the state EMS medical director;
10.3.3.e. A registered nurse with trauma and emergency care experience appointed by the STAC; and
10.3.3.f. A paramedic appointed by the state MPCC;
10.3.4. The MRC may make recommendations to OEMS or to the state and regional MPCC concerning disciplinary actions or system policy issues as outlined in MRC operational guidelines established by OEMS.
10.3.5. The chair of a MRC may, with the approval of the committee, temporarily appoint certain specialists to the committee as may be required to adequately and appropriately review a particular case. The temporary members shall follow all policies and procedures established by the committee and OEMS.
10.3.6. If a designated facility or a licensed EMS agency fails to participate and abide by the policies and procedures governing the operation of the MRC, the Secretary may suspend or revoke the designation status or license of the facility or EMS agency.
W. Va. Code R. § 64-27-11 Administrative Due Process
11.1. The provisions of W. Va. Code §16-4C-10 apply.
11.2. Those persons adversely affected by the enforcement of this rule desiring a contested case hearing to determine any rights, duties, interests, or privileges shall do so in a manner prescribed “Rules of Procedure for Contested Case Hearings and Declaratory Rulings,” 64CSR1.
Series 32 Vital Statistics
W. Va. Code R. § 64-32-1 General
1.1. Scope. -- This legislative rule complements W. Va. Code §16-5-1 et seq., the State Vital Statistics Law.
1.2. Authority. -- W. Va. Code §16-1-4 and §16-5-3.
1.3. Filing Date. -- May 8, 2025.
1.4. Effective Date. -- May 8, 2025.
1.5. Sunset Provision. -- This rule shall terminate and have no further force or effect on August 1, 2030.
W. Va. Code R. § 64-32-2 Duties of State Registrar
2.1. Media, Forms, Certificates, Electronic Data Files.
2.1.1. All forms, certificates, records, electronic data files, and reports used in the system of vital statistics are the property of the Bureau and shall be surrendered to the State Registrar upon demand. The forms prescribed and distributed by the State Registrar for reporting vital statistics shall be used only for official purposes. Only those forms furnished or approved by the State Registrar shall be used in the reporting of vital statistics or in making copies. Electronic data records will be accepted only when standards set by the State Registrar are met and with the prior approval of the State Registrar before transmission.
2.2. Requirements for Preparation of Certificates.
2.2.1. All forms, certificates, and reports relating to vital statistics shall be completed in digital form as approved by the State Registrar. In the event forms, certificates, or reports are unable to be completed digitally, they shall either be typewritten or printed legibly in black, unfading ink. All signatures required shall be entered in unfading ink or stored electronically. Unless otherwise directed by the State Registrar, a certificate is not complete and correct and acceptable for registration that:
2.2.1.a. Does not contain the certifier’s name typed or, in the event a certificate, form, or report is unable to be completed digitally, printed legibly under his or her signature;
2.2.1.b. Does not supply all items of information called for or satisfactorily account for their omission;
2.2.1.c. Contains alterations or erasures;
2.2.1.d. Does not contain an approved electronic signature or, in the event a certificate, form, or report is unable to be completed digitally, a handwritten signature;
2.2.1.e. Is marked “copy” or “duplicate”;
2.2.1.f. Is a carbon copy;
2.2.1.g. Is prepared on an improper form;
2.2.1.h. Contains improper or inconsistent data;
2.2.1.i. Contains items completed with pictographs or ideographs or writing that is not part of the standard 26-letter English alphabet or modifications thereof;
2.2.1.j. Contains given names or surnames written with symbols that have no phonetic standing on their own other than numerals used for generational identifiers or common punctuation such as hyphens for hyphenated names, apostrophes used as part of a given name or surname, commas to separate surnames from generational identifiers, and periods in generational identifiers or when an initial or abbreviation is used as part of a name;
2.2.1.k. Contains an indefinite cause of death which denotes only symptoms of disease or conditions resulting in disease; or
2.2.1.l. Is not prepared in conformity with rules or instructions issued by the State Registrar.
W. Va. Code R. § 64-32-3 Birth Registration for Out-of-Institution Birth Documentary Evidence
3.1. When a birth occurs in this State outside of a hospital or institution, and the birth certificate is filed before the first birthday, the State Registrar may require additional evidence in support of the facts of birth.
3.2. The State Registrar shall complete and file a certificate of birth upon presentation of the following evidence by the individual responsible for filing the certificate:
3.2.1. Evidence of pregnancy, such as, but not limited to:
3.2.1.a. A prenatal record;
3.2.1.b. A statement from a physician or other health care provider qualified to determine pregnancy;
3.2.1.c. A home visit by a public health nurse or other health care provider; or
3.2.1.d. Other evidence acceptable to the State Registrar;
3.2.2. Evidence that the infant was born alive, such as, but not limited to:
3.2.2.a. A statement from the physician or other health care provider who saw or examined the infant;
3.2.2.b. An observation of the infant during a home visit by a public health nurse; or
3.2.2.c. Other evidence acceptable to the State Registrar;
3.2.3. Evidence of the mother’s presence in West Virginia on the date of the birth, such as, but not limited to:
3.2.3.a. If the birth occurred in the mother’s residence;
3.2.3.a.1. A driver’s license, or a government-issued identification card, which includes the mother’s current residence on the face of the license or card;
3.2.3.a.2. A rent receipt that includes the mother’s name and address;
3.2.3.a.3. Any type of utility, telephone, or other bill that includes the mother’s name and address; or
3.2.3.a.4. Other evidence acceptable to the State Registrar; or
3.2.3.b. If the birth occurred outside of the mother’s place of residence, and the mother is a resident of West Virginia, the evidence shall consist of:
3.2.3.b.1. A notarized affidavit from the tenant of the premises where the birth occurred, that the mother was present at those premises at the time of the birth;
3.2.3.b.2. Evidence of the affiant’s residence similar to that required in subsection 3.2. of this section;
3.2.3.b.3. Evidence of the mother’s residence in the State similar to that required in subsection 3.2. of this section; or
3.2.3.b.4. Other evidence acceptable to the State Registrar; and
3.2.3.c. If the mother is not a resident of West Virginia, the evidence shall consist of clear and convincing evidence acceptable to the State Registrar.
W. Va. Code R. § 64-32-4 Infants of Unknown Parentage; Foundling Registration
4.1. The report for an infant of unknown parentage shall be registered on a current certificate of live birth and shall:
4.1.1. Have “foundling” plainly marked in the top margin of the certificate;
4.1.2. Show the required facts as determined by approximation and have parentage data left blank; and
4.1.3. Show the name and title of the custodian in lieu of the attendant.
4.2. When a report has been placed in a special file as provided by W. Va. Code §16-5-13(d), the State Registrar may inspect the information for purposes of properly administering the system of vital statistics.
4.3. A child relinquished pursuant to W. Va. Code §49-4-201, and whose birth is to be registered, shall be filed at the direction of the State Registrar.
W. Va. Code R. § 64-32-5 Delayed Registration of Birth
5.1. Delayed Certificate of Birth Form.
5.1.1. All certificates registered one year or more after the date of birth shall be registered on a delayed certificate of birth prescribed and furnished by the State Registrar.
5.2. Who May Request the Registration of a Delayed Certificate of Birth.
5.2.1. Any person born in this State whose birth is not recorded in this State, his or her parent or guardian, or any other person age 18 years or over acting for the registrant and having personal knowledge of the facts of birth may request registration of a delayed certificate of birth, subject to this rule and instructions issued by the State Registrar.
5.2.2. Each application for a delayed certificate of birth shall be signed and sworn to before an official authorized to administer oaths by the person whose birth is to be registered if that person is 18 years of age or over and is competent to sign and swear to the accuracy of the facts stated in the application; otherwise the application shall be signed and sworn to by one of the parents of the registrant, his or her guardian, or any other person age 18 years or over having personal knowledge of the facts of birth.
5.3. Facts to be Established for a Delayed Registration of Birth.
5.3.1. The minimum facts which shall be established by documentary evidence shall be the following:
5.3.1.a. The full name of the person at the time of birth;
5.3.1.b. The date of birth and state of birth;
5.3.1.c. The full maiden name of the mother; and
5.3.1.d. The full name of the father; except that if the mother was not married either at the time of conception or birth the name of the father shall not be entered on the delayed certificate except as provided in subsection 5.4. of this section.
5.4. Delayed Registration Following a Legal Change of Status.
5.4.1. The State Registrar may establish a new delayed certificate of birth reflecting changes when evidence is presented reflecting a legal change of status by adoption, legitimation, paternity determination, or acknowledgment of paternity.
5.4.2. The State Registrar shall place the existing certificate and the evidence upon which the new certificate was based in a special file. The file shall not be subject to inspection except upon order of a court of competent jurisdiction or by the State Registrar for purposes of properly administering the system of vital statistics.
5.5. Documentary Evidence -- Requirements.
5.5.1. To be acceptable for filing, the name of the registrant at the time of the birth and the date and place of birth entered on a delayed certificate of birth shall be supported by at least:
5.5.1.a. A hospital record created at the time of birth, or two pieces of acceptable documentary evidence, if the record is filed within 10 years after the date of birth; or
5.5.1.b. Three pieces of acceptable documentary evidence, if the record is filed 10 years or more after the date of birth.
5.5.2. Facts of parentage shall be supported by at least one document.
5.6. Documentary Evidence -- Acceptability.
5.6.1. The State Registrar shall determine the acceptability of all documentary evidence submitted.
5.6.1.a. Documents presented, including but not limited to census, hospital, church, and school records, shall be from independent sources and shall be in the form of the original record or a duly certified copy or a signed statement from the custodian of the record or document. Documents must have been established at least one year prior to the date of application.
5.6.1.a.1. Affidavits of personal knowledge are not acceptable as evidence to establish a delayed certificate of birth unless the registrant is at least 10 years of age and the affidavit is signed by one of the parents.
5.6.1.b. All documents submitted in evidence:
5.6.1.b.1. For persons age 10 years or over, except for affidavits of personal knowledge, must have been established at least 10 years prior to the date of application, or within three years of the date of birth; and
5.6.1.b.2. For persons under 10 years of age, must be dated at least one year prior to the date of application or within the first year of life.
5.7. Abstraction of Documentary Evidence.
5.7.1. The State Registrar shall abstract on the delayed certificate of birth a description of each document submitted to support the facts shown on the delayed birth certificate. This description shall include:
5.7.1.a. The title or description of the document;
5.7.1.b. The name and address of the custodian;
5.7.1.c. The date of the original filing of the document being abstracted; and
5.7.1.d. All birth facts required by subsection 5.3. of this section contained in each document accepted as evidence.
5.7.2. The State Registrar shall return all documents submitted in support of the delayed birth registration to the applicant after review except for an affidavit of personal knowledge if submitted as documentation.
5.8. Verification by the State Registrar.
5.8.1. The State Registrar shall verify:
5.8.1.a. That no prior birth certificate is on file for the person whose birth is to be recorded;
5.8.1.b. That he or she has reviewed the evidence submitted to establish the facts of birth; and
5.8.1.c. That the abstract of the evidence appearing on the delayed certificate of birth accurately reflects the nature and content of the document.
5.9. Dismissal After One Year.
5.9.1. The State Registrar may dismiss applications for delayed certificates which have not been completed within one year from the date of application. Upon dismissal, the State Registrar shall so advise the applicant and shall return all documents submitted in support of the registration.
W. Va. Code R. § 64-32-6 Certificates of Birth Following Adoption, Legitimation, Paternity Determination, and Paternity Acknowledgment
6.1. Legitimation.
6.1.1. The State Registrar shall prepare a new certificate of birth for a child born in West Virginia if the natural parents marry after the birth of the child and upon receipt of sworn acknowledgment of paternity and a certified copy of the parents’ marriage record. However, if another man is shown as the father on the original certificate of birth, the State Registrar may prepare a new certificate of birth only when a determination of paternity is made by a court of competent jurisdiction or following adoption.
6.2. Court Determination of Paternity.
6.2.1. The State Registrar shall prepare a new certificate of birth for a child born in West Virginia upon receipt of a certified copy of a court determination of paternity. If a new surname of the child is not decreed by the court, the parents or legal guardian may specify a new surname to be placed on the certificate of birth as long as the registrant is under eighteen years of age.
6.3. Acknowledgment of Paternity.
6.3.1. The State Registrar shall prepare a new certificate of birth for a child born out of wedlock in this State upon receipt of a sworn acknowledgment of paternity signed by both parents and a written request by both parents that the child’s surname remain the same or be changed on the certificate. However, if another man is shown as the father of the child on the original certificate, the State Registrar may prepare a new certificate only when a determination of paternity is made by a court of competent jurisdiction or following adoption.
6.4. In lieu of preparing a new birth certificate under the provisions of subsections 6.1, 6.2, and 6.3 of this section, the State Registrar may alter the original certificate provided that the fact of alteration is not obvious on the face of the certificate.
6.5. New Certificate.
6.5.1. The new certificate of birth prepared after adoption, legitimation, court determination of paternity, or acknowledgment of paternity shall be on the form in use at the time of its preparation and shall include the following items and any information necessary to complete the certificate:
6.5.1.a. The name of the child;
6.5.1.b. The date and city and/or county of birth as transcribed from the original certificate;
6.5.1.c. The names and personal particulars of the adoptive parents or of the natural parents, whichever is appropriate;
6.5.1.d. The name of the attendant;
6.5.1.e. The birth number assigned to the original birth certificate; and
6.5.1.f. The original filing date.
6.5.2. The State Registrar shall prescribe or approve forms for the submission of the information necessary to locate the existing certificate and to complete the new certificate.
6.6. Existing Certificate to Be Placed in a Special File.
6.6.1. After preparation of the new certificate, the State Registrar shall place the existing certificate and the evidence upon which the new certificate was based in a special file. The file shall not be subject to inspection except upon order of a court of competent jurisdiction or by the State Registrar for purposes of properly administering the system of vital statistics or as otherwise provided by the W. Va. Code or the Code of State Rules.
W. Va. Code R. § 64-32-7 Death Registration
7.1. Acceptance of Incomplete Death Certificate.
7.1.1. If all the information necessary to complete a death certificate is not available within the time prescribed for filing of the certificate, the funeral director or person acting in that capacity shall file the certificate with all information that is available and satisfactorily account for all the items that are omitted. In all cases the medical certification must be provided by the person responsible for the certification. If the cause of death is unknown or pending investigation, the cause of death shall be shown in those terms on the certificate. The person providing the medical certification of cause of death also shall authorize the final disposition of the body
7.1.2. The funeral director or person acting in that capacity shall file a supplemental report providing the personal information omitted from the original certificate with the State Registrar as soon as possible, but in all cases within 30 days of the date the death occurred.
7.1.3. The certifier responsible for providing the medical information shall file a supplemental report providing the medical information omitted from the original certificate with the State Registrar within 30 days of the date the death occurred. If extended time is needed to get information, the certifier shall notify the State Registrar. The State Registrar may provide for an extension not to exceed 60 days or as necessary in cases in which the certifier is a State Medical Examiner or his or her designee or the county medical examiner or county coroner.
7.1.4. The State Registrar may direct that a supplemental report be made a part of the existing death certificate. The reports shall be considered an amendment and the death certificate shall be marked “Amended.”
7.2. Hospital or Institution Shall Assist in Preparation of Certificate.
7.2.1. When a death occurs in a hospital or other institution and the death is not under the jurisdiction of the Chief Medical Examiner or his or her designee or the county medical examiner or county coroner, the person in charge of the institution, or his or her designated representative, shall initiate the preparation of the death certificate by:
7.2.1.a. Placing the full name of the decedent and the date, time, and place of death on the death certificate and obtaining from the attending physician placed in charge of the decedent’s care at the time of death or another certifier as specified in W. Va. Code §16-5-19(c)(1) the medical certification of the cause of death; or
7.2.1.b. If the attending physician placed in charge of the decedent’s care is not the pronouncing physician, placing the full name of the decedent and the date, time, and place of death on the death certificate, providing the name of the attending physician placed in charge of the decedent’s care to the funeral director or person acting in that capacity. The hospital or institution shall obtain the pronouncing physician’s or other pronouncing licensed health professional’s attestation when the attending physician placed in charge of the decedent’s care or another certifier as specified in W. Va. Code §16-5-19(c)(1) is absent; and
7.2.1.c. Presenting the partially completed death certificate to the funeral director or person acting in that capacity.
W. Va. Code R. § 64-32-8 Delayed Registration of Death
8.1. The registration of a death after the time prescribed by the W. Va. Code and the Code of State Rules shall be registered on the current certificate of death form or an alternate delayed certificate of death form in the manner prescribed in this subsection.
8.1.1. If the attending physician or another certifier as specified in W. Va. Code §16-5-19(c)(1) or the Chief Medical Examiner or his or her designee or the county medical examiner or the county coroner at the time of death and the attending funeral director or person who acted in that capacity are available to complete the certificate of death, it may be completed without additional evidence and filed with the State Registrar. For those certificates filed one year or more after the date of death, the attending physician or another certifier as specified in W. Va. Code §16-5-19(c)(1) or the State Medical Examiner or his or her designee or the county medical examiner or the county coroner and the funeral director or person who acted in that capacity shall state in accompanying affidavits that the information on the certificate is based on records kept in their files. Delayed registrations of death filed under this provision are to be filed on the current certificate of death form and are to be stamped “Delayed.”
8.1.2. In the absence of the attending physician or another certifier as specified in W. Va. Code §16-5-19(c)(1) or the Chief Medical Examiner or his or her designee or the county medical examiner or the county coroner and the funeral director or person who acted in that capacity, the certificate may be filed by the next of kin or spouse of the decedent and shall be accompanied by two documents which identify the decedent and his or her date and place of death. Delayed registrations of death filed under this provision are to be filed using a delayed certificate of death form provided by the State Registrar. A summary statement of the evidence submitted in support of the delayed registration shall be endorsed on the delayed certificate of death form.
8.2. In all cases, the State Registrar may require additional documentary evidence to prove the facts of death.
W. Va. Code R. § 64-32-9 Disposition of Reports of Fetal Death and Induced Termination of Pregnancy
9.1. Reports of induced termination of pregnancy are statistical reports only. The State Registrar may dispose of the reports when all statistical processing of the reports has been accomplished. However, the State Registrar may establish a file of the reports so they will be available for future statistical and research projects. The file shall be retained for as long as the State Registrar considers necessary and then he or she shall destroy it. The file may be maintained by photographic, electronic, or other means as determined by the State Registrar, in which case the original report from which the photographic, electronic, or other file was made shall be destroyed.
9.2. The provisions of this rule also apply to all records or reports of fetal death and are also applicable to filings of reports of induced termination of pregnancy filed prior to the adoption of this rule. Reports of fetal death filed prior to the adoption of this rule shall be retained indefinitely as the original files or photographic or electronic files.
W. Va. Code R. § 64-32-10 Authorization for Final Disposition
10.1. Removal of Body.
10.1.1. Before removing a dead body or fetus from the place of death, the funeral director or person acting in that capacity shall:
10.1.1.a. Obtain assurance from the attending physician or another certifier as specified in W. Va. Code §16-5-19(c)(1), the physician or other licensed health professional who pronounces death that the death is from natural causes and that the attending physician placed in charge of the decedent’s care or another certifier as specified in W. Va. Code §16-5-19(c)(1) will assume or has assumed responsibility for certifying to the cause of death or fetal death and receive permission to remove the body from the place of death; or
10.1.1.b. Notify the Chief Medical Examiner or his or her designee or the county medical examiner or the county coroner if the case comes within his or her jurisdiction and obtain authorization to remove the body.
10.2. Special Allowance for Hardship Cases.
10.2.1. In deaths that have been referred to the West Virginia Office of the Chief Medical Examiner, their coroner, or designee, and it has been determined that:
10.2.1.a. The death does not fall under the purview of the Office of the Chief Medical Examiner;
10.2.1.b. The attending physician or other medical certifier is unavailable to allow for removal and final disposition of the body within a time period to prevent an undue hardship to the family; and
10.2.1.c. With consent by the Office of the Chief Medical Examiner, their coroner, or designee, that separate authorization for removal of the body and the authorization for disposition signed by the attending physician or other medical certifier who is to certify to the cause of death is not necessary before removal and final disposition.
10.3. Authorization for Disinterment and Reinterment.
10.3.1. Upon receipt of a written application signed by the next of kin or spouse and the person who is in charge of a disinterment or upon receipt of an order of a court of competent jurisdiction which directs a disinterment, the State Registrar shall issue an authorization for the disinterment and reinterment of a dead body to a licensed funeral director.
10.3.2. Upon receipt of a court order or signed permission of the next of kin or spouse, the State Registrar may issue one authorization to a licensed funeral director to permit disinterment and reinterment of all remains in a mass disinterment provided that, insofar as possible, the remains of each body are identified and the place of disinterment and reinterment are specified. The authorization shall be permission for disinterment, transportation, and reinterment.
10.3.3. A dead body deposited in a receiving vault shall not be considered a disinterment when removed from the vault for disposition.
10.3.4. In all cases a court of competent jurisdiction must order disinterment and reinterment before issuance of authorization in which it is the intention that the disinterment of a dead body is to be performed and the casket is to be opened for any purpose, other than solely for removal of the remains for subsequent cremation authorized by a cremation permit issued by the Office of the Chief Medical Examiner.
W. Va. Code R. § 64-32-11 Registration of Marriage and Delayed Registration of Marriage
(Reserved for future use)
W. Va. Code R. § 64-32-12 Amendment of Vital Records
12.1. Amendment of Minor Errors on Birth Certificates During the First Year.
12.1.1. Amendment of obvious errors, transposition of letters in words of common knowledge, or omissions may be made by the State Registrar within the first year after the date of birth either upon his or her own observation or query or upon request of a person as defined in subsection 12.3 of this section. When the additions or minor amendments are made by the State Registrar, a notation as to the source of the information, together with the date the change was made and the initials of the authorized agent making the change shall be made on the certificate in such a way as not to become a part of any certified copy issued. The certificate shall not be marked “Amended.”
12.2. All Other Amendments.
12.2.1. Unless otherwise provided in this rule or in the W. Va. Code, all other amendments to vital records shall be supported by:
12.2.1.a. A notarized affidavit setting forth:
12.2.1.a.1. Information to identify the certificate;
12.2.1.a.2. The incorrect data as listed on the certificate;
12.2.1.a.3. The correct data as it should appear; and
12.2.1.b. One or more items of documentary evidence which support the alleged facts and were established at least five years prior to the date of application for amendment or within seven years of the date of the event.
12.2.2. The State Registrar shall evaluate the evidence submitted in support of any amendment, and when he or she finds reason to doubt its validity or adequacy, he or she may reject the amendment and advise the applicant of the reasons for this action.
12.2.3. The State Registrar may in all cases require additional documentation.
12.2.4. Any other amendment to vital records not specifically provided for in this rule or in the W. Va. Code or one which was previously rejected by the State Registrar shall be made in accordance with an Order from a court of competent jurisdiction.
12.3. Who May Apply.
12.3.1. One of the parents if the registrant is under 18 years of age, the guardian or legal representative working in behalf of the registrant, the registrant if he or she is age 18 years or over, or the individual responsible for filing the certificates may make application to amend a birth certificate. In all other cases, an amendment shall be made by court order.
12.3.2. The next of kin or spouse, the informant listed on the death certificate, or the funeral director or person acting in that capacity who submitted the death certificate may make application to amend a death certificate. The physician or the Chief Medical Examiner or his or her designee or the county medical examiner or the county coroner who certified to the cause of death are the only parties who may make application to amend the medical certification of the cause of death.
12.3.3. The county clerk in the county in which a marriage license was issued may accept applications for amendment of the facts of marriage. The application shall be made jointly by both parties to the marriage or by the survivor. In the event the marriage to which the application relates was terminated by divorce, dissolution of marriage, or annulment on or before the date of application for amendment, the applicant may request amendment only of those items on the certificate of marriage which relate to the applicant.
12.3.4. Either party to a terminated marriage may make application for amendment of matters contained in certificates of divorce, dissolution of marriage, or annulment which are not part of the decree or court order. The court that terminated a marriage may make application for amendment of matters contained in certificates of divorce, dissolution of marriage, or annulment which are part of the decree or court order.
12.3.5. Amendments to delayed certificates of birth other than the correction of minor errors or the establishment of paternity by affidavit of paternity, shall be made by court order.
12.4. Amendment of Registrant’s Given Names on Birth Certificates Within the First Year.
12.4.1. The parent or parents, if both are named on the birth certificate, or the guardian, person, or agency having legal custody of the registrant may, until the registrant’s first birthday, amend the given names by submission of a notarized affidavit.
12.4.2. After one year from the date of birth the provisions of subsection 12.2 of this section shall be followed to amend a given name if the name was entered incorrectly on the birth certificate. After one year a court of competent jurisdiction must submit a legal change of name order to change a given name.
12.5. Addition of Given Names on Birth Certificates.
12.5.1. For a child whose birth was recorded with no given names, the parent, or parents if both are named on the birth certificate, or the guardian, person, or agency having legal custody of the registrant may, until the registrant’s seventh birthday, submit a notarized affidavit to add the given names to the certificate of birth.
12.5.2. After seven years of age the provisions of subsection 12.2 of this rule shall be followed to add given names.
12.6. Amendment of Cause of Death.
12.6.1. The State Registrar may amend the cause of death only upon receipt of a signed statement or by an approved electronic notification by the physician or the Chief Medical Examiner or his or her designee or the county medical examiner or the county coroner who originally certified the cause of death. In the absence or inability of the physician or with his or her approval, the cause of death may be amended upon receipt of a signed statement or by an approved electronic notification from his or her associate physician, or the chief medical officer of the institution in which death occurred, or the Chief Medical Examiner or his or her designee, or the county medical examiner or the county coroner who assumes jurisdiction of the case provided that individual has access to the medical history of the case. The State Registrar may require documentary evidence to substantiate the requested amendment.
12.7. Amendment of the Same Item More than Once.
12.7.1. Once an amendment of an item is made on a vital record, except for causes or manners of death to be amended by the Chief Medical Examiner, or a clerical error on the part of the State Registrar, the State Registrar shall not amend that item again except upon receipt of a court order from a court of competent jurisdiction.
12.7.2. For purpose of accuracy only, the Chief Medical Examiner may at any time amend the cause and manner of death based on autopsy results, additional scientific study, or further inquiry or investigation for any death originally certified by the Chief Medical Examiner or his or her designee or the county medical examiner or the county coroner or for any death certified by another physician that the Chief Medical Examiner or his or her designee or the county medical examiner or the county coroner claims jurisdiction.
12.8. Methods of Amending Certificates.
12.8.1. The State Registrar may amend certificates of birth, death, marriage, divorce, dissolution of marriage, or annulment in the following manner:
12.8.1.a. Completing the item in any case where the item was left blank on the existing certificate.
12.8.1.b. Preparing a new certificate showing the correct information when the State Registrar determines that the nature of the amendment requires it.
12.8.1.b.1. The new certificate shall be prepared on the form used for registering current events at the time of the amendment. Except as provided elsewhere in this rule, the item number of the entry that was amended shall be identified on the new certificate.
12.8.1.b.2. In all cases, the new certificate shall show the date the amendment was made and be given the same State file number as the existing certificate. Signatures, if any, appearing on the existing certificate shall be typed on the new certificate.
12.8.1.c. Drawing a single line through the item to be amended and inserting the correct data immediately above or to the side of the item. The line drawn through the original entry shall not obliterate the entry.
12.8.1.d. In special circumstances, when determined necessary and proper by the State Registrar, completing a special form which shall include the incorrect information as it appears on the original certificate, the correct information as it should appear, an abstract of the documentation used to support the amendment and sufficient information about the registrant to link the special form to the original record. When a copy of the record is issued, a copy of the amendment shall be included or;
12.8.1.e. Amending a record maintained in an electronic file by changing the item or items to be amended. The date of amendment shall be made a part of the record and the original information shall also be retained.
12.9. Administrative Amendment.
12.9.1. Upon investigation of filed vital records incorporated into the holdings of the State Registrar or a local registrar or local custodian that were filed with incomplete or missing file dates or registrar’s signatures, the State Registrar shall, if possible by approximation or other means, make an administrative amendment to the record. The records shall be marked “Amended” and the date of the amendment shall be noted in administrative files indexed to the corrected record.
W. Va. Code R. § 64-32-13 Record Preservation
13.1. When an authorized reproduction of a vital record has been properly prepared by the State Registrar and when all steps have been taken to ensure the continued preservation of the information, the record from which the authorized reproduction was made may be disposed of by the State Registrar. However, the State Registrar may not dispose of the record until the quality of the authorized reproduction has been tested to ensure that acceptable certified copies can be issued and until a security copy of the document has been placed in a secure location removed from the building where the authorized reproduction is housed. The State Registrar shall maintain the security copy in such a manner to ensure that it can replace the authorized reproduction should the authorized reproduction be lost or destroyed.
13.2. The State Registrar shall offer the original documents from which the authorized reproductions are made to the section of Archives and History of the Division of Culture and History - hereinafter known as the “State Archives”. The State Archives may retain permanently the records provided if they adhere to the restrictions in the vital statistics law related to access to the records. If the State Archives does not wish to place the records in its files the State Registrar may destroy the documents in accordance with W. Va. Code and the rules of the State Archives. The destruction shall be by approved methods for disposition of confidential or sensitive documents.
W. Va. Code R. § 64-32-14 Disclosure and Protection of Integrity of Vital Records
14.1. The State Registrar, a local registrar, or any other custodian of vital records shall not permit inspection of, or disclose information contained in, vital statistics records, or copy or issue a copy of all or part of any vital statistics record unless he or she is satisfied that the applicant is authorized to obtain a copy or abstract of the record.
14.1.1. Unless access to vital records would jeopardize acceptance by any agency of the federal government as specified in regulations promulgated under the Intelligence Reform Act or other similar provisions of federal law, in addition to applicants specified in W. Va. Code §16-5-28(a), the following persons or entities are authorized to obtain a copy or abstract of a vital record:
14.1.1.a. A person or entity who can prove that they have a direct and tangible interest in the content of the record and that the information contained in the record is necessary for the determination of a personal or property right.
14.1.1.b. In the case of birth records, the registrant, a member of his or her immediate family, his or her guardian, or their respective authorized representatives.
14.1.1.c. In the case of a death record, any immediate family member, any surviving relative who has a direct or tangible interest in the record, or their authorized representative.
14.1.1.d. In the case of a fetal death record or report, a parent listed on the record or his or her authorized representative.
14.1.1.e. In the case of marriage and divorce records, the parties married, their adult children, adult grandchildren, and additional generations or their authorized representatives.
14.1.2. Family members doing genealogical research and genealogists representing a family member may obtain copies of records needed for their research. The registrant or relevant family members as defined in §16-5-28(a) of the W. Va. Code or the Code of State Rules promulgated shall submit appropriate authorization.
14.1.3. The term “authorized representative” includes an attorney, physician, funeral director, or other designated agent acting on behalf of the registrant or his or her family.
14.1.4. The term “immediate family” includes:
14.1.4.a. A mother or father;
14.1.4.b. A son or daughter;
14.1.4.c. A brother or sister;
14.1.4.d. A husband or wife;
14.1.4.e. A mother-in-law or father-in-law;
14.1.4.f. A son-in-law or daughter-in-law;
14.1.4.g. Grandparents, great-grandparents, and additional generations of the same family;
14.1.4.h. Grandchildren, great-grandchildren, and additional generations of the same family;
14.1.4.i. A stepmother or stepfather; and
14.1.4.j. A stepchild.
14.1.5. If the father’s name is not shown on the certificate of birth, he or his family members cannot obtain copies of the record without a court order, a court ordered determination of paternity naming him as the father, a completed notarized affidavit of paternity accepted for filing by the section of vital statistics, proof of marriage to the mother at the time of conception or birth of the child, or proof of adoption.
14.1.6. The natural parents of adopted children may not obtain copies or abstracts of the record unless the requesting natural parent retains legal rights as a parent after the adoption.
14.1.7. The State Registrar shall not provide listings of names or addresses from vital records to the general public for private use or distribution or commercial firms or agencies for commercial or business use.
14.2. All requests for disclosure of information contained in vital records or reports for research which identifies any person or institution shall be submitted in writing or by an approved electronic process to the State Registrar.
14.2.1. Each request shall contain:
14.2.1.a. The objectives of the research;
14.2.1.b. Peer review and approval of the research protocol for any contact of research subjects or their families;
14.2.1.c. Storage and security measures to be taken to assure confidentiality of identifying information, and provision for return or destruction of the information at the conclusion of the research;
14.2.1.d. A time frame for the research;
14.2.1.e. An acknowledgment and agreement that ownership of all information provided by the State Registrar remains exclusively in the Bureau and that use of the information by the researcher constitutes a license only for usage during the course of the research and creates no ownership rights by the researcher; and
14.2.1.f. An acknowledgment and agreement that release of identifying information contained in vital records or reports by the researcher to any other person or entity may be made only with prior written approval of the State Registrar.
14.2.2. The State Registrar shall review all requests to determine compliance with the following:
14.2.2.a. The request contains all required elements;
14.2.2.b. The request adequately justifies the need for the requested information;
14.2.2.c. The requested information can be provided within the time frame set forth in the request; and
14.2.2.d. The Bureau has adequate resources with which to comply with the request;
14.2.3. The State Registrar shall enter into research agreements for all approved research requests. Each research agreement shall specify exactly what information will be disclosed and shall prohibit release by the researcher of any information which may identify any person or institution. Additionally, each research agreement may provide that in the event of a breach of the agreement the principal investigators and collaborators shall be barred from participation in future research agreements and shall pay to the Bureau the sum of $5,000 per violation of the research agreement.
14.2.4. For all requests for disclosure of information contained in vital records or reports for research which do not contain identifiers but may identify any person or institution, the State Registrar shall obtain a signed agreement from the person or entity requesting the information which provides the following assurances:
14.2.4.a. The recipient will neither use nor permit others to use the information in any way except for statistics reporting and analysis;
14.2.4.b. The recipient will neither release nor permit other persons or entities to release the information or any part of the information to any person who is not a member of the organization without approval of the State Registrar;
14.2.4.c. The recipient will neither attempt to link nor permit others to attempt to link the data set with individual identifiable records from any other data set;
14.2.4.d. The recipient will neither use nor will allow anyone else to attempt to use the information to learn the identity of any person or institution included in the information provided; and
14.2.4.e. If the identity of any person or institution is discovered inadvertently, the recipient will not make use of this knowledge; will immediately notify the State Registrar; will safeguard or destroy information which led to the identification of the individual or institution as requested by the State Registrar; and will inform no one else of the discovery.
14.3. The State Registrar, a local registrar, or another custodian shall not issue a certified copy of a record until the applicant has provided sufficient information to locate the record. Whenever it is necessary to establish an applicant’s right to information from a vital record, the State Registrar, a local registrar, or another custodian may also require identification of the applicant or a sworn statement or other good and sufficient evidence of the applicant’s identity and his or her right to the information.
14.4. When 100 years have elapsed after the date of birth, or 50 years have elapsed after the date of death, fetal death, marriage or divorce, dissolution of marriage, or annulment, the records in the custody of the State Registrar, a local registrar or another custodian, unless otherwise prohibited by statute or rules promulgated, shall become available to any person upon submission of an application containing sufficient information to locate the record. For each copy issued or search of the files made, the State Registrar or local custodian shall collect the same fee charged for the issuance of certified copies or a search of the files for other records in his or her possession.
W. Va. Code R. § 64-32-15 Copies of Data from Vital Records
15.1. The State Registrar, local registrars, and other custodians authorized by the W. Va. Code to produce certified copies of vital records may produce certified copies by mechanical, electronic, or other reproductive processes.
15.2. Each certified copy issued shall be certified as a true copy by the officer in whose custody the record is entrusted and shall include the date issued, the name of the issuing officer, the State Registrar’s, local registrar’s, or another custodian’s signature or an authorized facsimile thereof, and the seal of the issuing office. In addition, all certified copies of a birth record shall include at a minimum the following information: a certificate or file number or other indexing reference, the given name or names, the surname, a generational identifier, if any, the date of birth, the state and city or county of birth, the sex, the name of the parents when known, and the date of filing. In addition, all certified copies of a death record shall include at a minimum the following information: the given names, the surnames, a generational identifier, if any, the date of death, the date of birth or age, the state and city or county of death, the sex, and the date of filing.
15.3. All certified copies shall include the minimum security features required for acceptance by federal agencies as specified in regulations promulgated under the Information Reform Act or similar federal statutes and shall include:
15.3.1. Sensitized security paper;
15.3.2. A background security design;
15.3.3. A copy void pantograph; and
15.3.4. Consecutive numbering;
15.4. To further enhance security, the State Registrar, local registrar, and other custodians may use other security features including, but not limited to, engraved borders, prismatic printing, erasable fluorescent background inks, nonoptical brightener paper, microline printing, complex colors, security threads or fibers, intaglio print, security laminates, and toner adhesion.
15.4.1. All paper to produce certified copies shall be obtained from a printing company with offices located within the United States or Canada and be printed within the United States or Canada.
15.5. Verification of the facts contained in a vital record may be furnished by the State Registrar to any federal, state, county, or municipal government agency or to any other agency representing the interest of the registrant. The verifications shall be on a form prescribed and furnished by the State Registrar or on a form furnished by the requesting agency and acceptable to the State Registrar; or the State Registrar may authorize the verification in other ways when it is in the best interests of his or her office.
W. Va. Code R. § 64-32-16 Fees
16.1. Unless specifically approved by the State Registrar or as otherwise provided by the W. Va. Code or the Code of State Rules, the State Registrar shall not issue a certified or uncertified copy of a vital record until the fee for the copy is received.
W. Va. Code R. § 64-32-17 Persons Required to Keep Records
17.1. Each funeral director shall keep a record containing, as a minimum, the following information about each dead body or fetus the funeral director handles:
17.1.1. The date, place, and time of receipt;
17.1.2. The date, place, and manner of disposition;
17.1.3. If the dead body or fetus is delivered to another funeral director, the date of the delivery and the name and address of the funeral director to whom it was delivered; and
17.1.4. The items required by the certificate of death for those deaths for which the funeral director was required to file the certificate.
W. Va. Code R. § 64-32-18 Matching of Birth and Death Certificates
18.1. When carrying out the birth and death matching program, the State Registrar shall establish written guidelines which provide the standards for determining a match does exist. These standards shall specify the information about the decedent which should be available and which should be compared to the information on the birth certificate before a match can be made. These items include as a minimum whenever possible: the name of the decedent; the name of the father and the maiden name of the mother; the date of birth or age of the decedent; the state of birth of the decedent; and the marital status of the decedent. The State Registrar shall not establish a match unless there is documented proof of the fact of death.
18.2. Once a match of a birth and a death is established, the State Registrar shall post the date of death, the state where the death occurred, and the death certificate number to the birth certificate or to an electronic record which identifies the birth certificate.
W. Va. Code R. § 64-32-19 Social Security Numbers to be Reported; No Good Cause for Refusal; Limitations on Use of Social Security Numbers
19.1. Persons or entities required under the W. Va. Code or the Code of State Rules to report social security numbers to the section of vital statistics shall do so.
19.2. Unless a social security number has not been assigned, or absent other provisions of federal regulations, the W. Va. Code or the Code of State Rules, there shall be no good cause for not furnishing a social security number.
19.3. Unless otherwise restricted by the W. Va. Code or the Code of State Rules, the State Registrar may use a social security number obtained from the filing of a vital record for all purposes approved by the Social Security Administration.
W. Va. Code R. § 64-32-20 Use of Names on Records
20.1. Birth Registration Generally.
20.1.1. Unless otherwise provided by the W. Va. Code or the Code of State Rules, birth certificates shall be filed by the State Registrar with the name of the registrant provided by the parents to the person or entity required to file the birth certificate unless:
20.1.1.a. The mother was an unemancipated minor, in which case the registrant’s surname may only be filed in the legal surname of the mother until paternity is established unless specifically allowed otherwise, in writing or by an approved electronic process, by the unemancipated minor’s mother’s parents or legal guardian or at the order of a court of competent jurisdiction; or
20.1.1.b. It is known the registrant will be placed for adoption in which case the certificate of birth shall be filed with the registrant’s surname as either the legal surname or the maiden surname of the mother, as she directs; or
20.1.1.c. A court order from a court of competent jurisdiction exists that orders another name be registered; or
20.1.1.d. The name provided contains commonly recognized profanity or is otherwise demeaning, in which case the State Registrar shall only register the birth in the requested name by order of a court of competent jurisdiction.
20.2. Only one generational identifier may be used after the surname. Generational identifiers may not take the form of commonly conferred academic honorifics such as, but not limited to MD, JD, DO, Esq., BA, BS, MA, MS, or PhD, or other designations not commonly used as generational identifiers.
W. Va. Code R. § 64-32-21 Administrative Due Process
21.1. Those persons adversely affected by the enforcement of this rule desiring a contested case hearing to determine any rights, duties, interests, or privileges shall do so in a manner prescribed in the Rules of Procedure for Contested Case Hearings and Declaratory Rulings, 64CSR1.
Series 40 Manufactured Home Communities
W. Va. Code R. § 64-40-1 General
1.1. Scope. -- This rule establishes the requirements governing the construction, installation and operation of manufactured home communities.
1.2. Authority. -- W. Va. Code §16-1-4.
1.3. Filing Date. -- May 2, 2012.
1.4. Effective Date. -- May 2, 2012.
W. Va. Code R. § 64-40-2 Application and Enforcement
2.1. Application. -- This rule applies to the owners and operators of manufactured home communities.
2.2. Enforcement. -- The enforcement of this rule is vested with the Commissioner of the West Virginia Bureau for Public Health or his or her lawful designee.
W. Va. Code R. § 64-40-3 Definitions
3.1. Approved. -- A procedure of operation, installation, or construction which is in accordance with the standards, specifications, and instructions established by the Commissioner.
3.2. Commissioner. -- The Commissioner of the West Virginia Bureau for Public Health or his or her designee.
3.3. Health officer. -- The state health officer or the executive officer of the local board of health or his or her duly authorized representative.
3.4. Management building. -- A building or structure used for supplying essential goods or services for the use of manufactured home community occupants.
3.5. Manufactured Home. -- A structure, transportable in one or more sections, which in the traveling mode is eight body feet or more in width or forty or more feet in length or, when erected on site, is three hundred twenty or more square feet. The structure is built on a permanent chassis and designed to be used as a dwelling with or without a permanent foundation when connected to the required utilities, including the plumbing, heating, air-conditioning and electrical systems contained in the structure. The term includes any structure which meets all the requirements of this definition, except the size requirements and with respect to which the manufacturer voluntarily files a certificate which complies with the applicable federal standards. Calculations used to determine the number of square feet in a structure will be based on the structure's exterior dimensions measured at the largest horizontal projections when erected on site.
3.6. Manufactured home community. -- Any individual site, area, tract or parcel of land upon which four or more manufactured homes used or occupied for dwelling purposes are parked either free of charge or for monetary consideration and shall include any roadway, building, structure, installation, enclosure, or vehicle used or intended for use as a part of the facilities of the manufactured home community. All existing mobile home parks which meet this definition shall be renamed as “manufactured home communities” by this rule. The Bureau for Public Health legislative rule, Fees for Permits, 64CSR30, establishes a permit fee for mobile home parks. The established fee applies to all manufactured home communities regulated by this rule.
3.7. Manufactured home site. -- A parcel of land for the accommodation of one manufactured home, its accessory building or structures, and accessory equipment for the exclusive use of the occupants.
3.8. Manufactured home stand. -- That part of a manufactured home site which has been reserved for the placement of the manufactured home, appurtenant structures or additions.
3.9. Occupant. -- A person using a manufactured home or a manufactured home community as a dwelling.
3.10. Operator. -- A person who is in charge of the operation of a manufactured home community, or who allows a lot, site, area, tract or parcel of land to be used for the parking or occupancy of four or more manufactured homes.
3.11. Permit. -- A written document issued by the health authority giving a person permission to construct, install, alter, remodel, extend or operate a specific manufactured home community.
3.12. Person. -- An individual, partnership, association, syndicate, company, firm, trust, corporation, government, corporation, institution, department, division, bureau, agency, or any entity recognized by law.
3.13. Potable water. -- Water free from impurities, in amounts sufficient to cause disease or harmful physiological effects. The potable water shall comply with bacteriological, chemical, physical and radiological quality standards established by the Commissioner.
3.14. Sewer connection. -- The connection consisting of all pipes, fittings, and appurtenances from the waste drain outlet of a manufactured home to the inlet pipe of the corresponding sewer riser pipe of the sewage collection system serving a manufactured home community.
3.15. Sewer riser pipe. -- The portion of the sewer system which extends vertically above the ground elevation and terminates at a designated point at each manufactured home site.
3.16. Sewage Collection System. -- The system of piping and appurtenances for the collection and transportation of sewage from the individual manufactured home units to either the designated sewage treatment plant or to approved off-site disposal. Piping within the collection system is referred to as sewer pipe.
3.17. Water connection. -- The connection consisting of all pipes, fittings, and appurtenances from the water connection inlet of a manufactured home to the outlet pipe of the corresponding water riser pipe of the water distribution system serving a manufactured home community.
3.18. Water riser pipe. -- That portion of the water supply system serving a manufactured home community and which extends vertically above the ground elevation and terminates at a designated point at each manufactured home site.
3.19. Water supply system. -- A system of pipes, appurtenances and equipment for the collection, treatment, storage, or distribution of the water from the source of supply to the ultimate consumer.
W. Va. Code R. § 64-40-4 Design, Construction, Installation, Maintenance, and Operation of Manufactured Home Communities
4.1. In addition to meeting all applicable provisions of this rule, all manufactured home communities constructed or installed after the effective date of this rule, shall be constructed or installed in accordance with the plans, specifications, and instructions issued by the Commissioner.
4.2. The design, construction, installation, maintenance, and operation of a manufactured home community shall comply with all applicable provisions of this rule.
W. Va. Code R. § 64-40-5 Permits and Notices
5.1. Construction and installation permits.
5.1.a. On and after the date this becomes effective, except for minor repair, a person shall not construct or install a manufactured home community, or any part thereof, in the State of West Virginia, unless he or she possesses a permit issued by the Commissioner in his or her name for that specific construction or installation. The terms construct and install shall be construed to mean and include the terms extend and alter.
5.1.b. A permit for the construction or installation of a manufactured home community shall not be issued until an application for a construction or installation permit and detailed plans and specifications of the manufactured home community construction or installation have been submitted to the Commissioner for review and approval. Said application, plans, and specifications shall be submitted to the Commissioner at least forty-five (45) days prior to the date on which the action by that agency is desired.
5.1.c. An application for a permit shall be made in writing and submitted to the Commissioner on a form prescribed by the Commissioner, signed by the applicant or his or her authorized agent, and shall contain any information requested by the Commissioner to determine if the manufactured home community construction or installation is in compliance with all applicable provisions of this rule.
5.1.d. When upon review of the plans, specifications, and application for a permit, the Commissioner is satisfied that the proposed design, construction or installation of the manufactured home community is satisfactory, he or she shall issue a permit to proceed with that action.
5.1.e. The Commissioner shall deny a permit if the information on the application form, plans or specifications is incomplete, inaccurate, false or misleading, or indicates that the application provisions of this rule cannot be met. A permit to construct shall be issued or denied within forty-five (45) days of receipt of the completed application. Reasons for denial shall be in writing.
5.1.f. Only a person who complies with all the applicable provisions of this rule is entitled to receive and retain a permit.
5.1.g. When a permit has been suspended or revoked, any construction or installation of the manufactured home community shall immediately cease.
5.1.h. Permits shall not be transferrable or assignable and automatically become invalid upon a change of ownership or upon suspension or revocation.
5.1.i. If the construction or installation activities have not commenced within two (2) years from the date of issuance of a permit, the permit automatically expires.
5.1.j. The manufactured home community shall be constructed or installed in accordance with the plans and specifications approved by the Commissioner. Any deviation from the approved original plans or specifications must be submitted in writing to the Commissioner for review, and written approval obtained before such changes are made. The Commissioner shall approve or deny requests for any deviation from plans to construct or install within forty-five (45) days of receipt of the revised application.
5.2. Permit to operate.
5.2.a. A person shall not in any manner directly or indirectly conduct, control, manage, maintain, or operate a manufactured home community in the state of West Virginia unless that person has a valid permit issued by the health officer to operate the specific manufactured home community.
5.2.b. An application for a permit to operate a manufactured home community shall be made in writing to the health officer on a form prescribed by the Commissioner. The applicant or his or her authorized agent shall sign the application. It shall contain any information requested by the health officer to enable him or her to determine that the facility and its operation is in compliance with the applicable provisions of this rule.
5.2.c. The application for a permit shall be made at least fifteen (15) days before the actual or proposed operation of the manufactured home community is to be effected.
5.2.d. The health officer shall deny a permit if the information on the application form is incomplete, inaccurate, false, or misleading, or indicates that the applicable provisions of this rule cannot be met.
5.2.e. Only persons who comply with the applicable provisions of this rule shall be entitled to receive and retain a permit.
5.2.f. Manufactured home communities in operation at the time this rule becomes effective, and meeting all applicable prior rules, are eligible for a permit to operate: Provided, that any construction or installation taking place after the effective date of this rule shall be in compliance with all applicable provisions of this rule.
5.2.g. Manufactured home communities put into operation after the date this rule becomes effective shall comply in full with all applicable provisions of this rule.
5.2.h. Permits are not transferable or assignable and shall automatically become invalid upon a change of ownership or upon suspension or revocation.
5.2.i. A permit to operate expires at midnight on the 31st day of December following the date of issuance.
5.2.j. Application for renewal of permit shall be made at least fifteen (15) days prior to expiration date of existing permit.
5.2.k. In the event of a change in ownership of a manufactured home community an application for a permit to operate shall be made to the health officer by the person concerned at least fifteen (15) days before the proposed or actual change is affected.
5.2.l. A permit may be suspended or revoked by the health officer if it is found that the manufactured home community is maintained or operated in violation of this rule, or any law, rule, or ordinance applicable thereto, or in violation of the conditions stated on the permit.
5.2.m. A permit to operate shall not be reinstated until an inspection by the health officer determines that the manufactured home community is in compliance with all applicable provisions of this rule or any orders, rules or instructions issued by the health officer.
5.3. Notices.
Notwithstanding the other provisions of this rule, whenever the health officer finds at a manufactured home community unsanitary conditions or other conditions that may constitute a potential hazard to public health, he or she may without warning, or hearing, issue a written notice to the operator, citing the conditions, specifying the corrective action to be taken, and the time period in which the action shall be taken. If an imminent health hazard exists, the notice shall state that the permit to operate is immediately suspended.
W. Va. Code R. § 64-40-6 Inspection
6.1. Each manufactured home community shall be inspected once a year. The health officer shall also make as many additional inspections of the manufactured home community as he or she considers necessary to determine satisfactory compliance with the provisions of this rule and any orders, notices, instructions, or specifications issued pursuant to this rule.
6.2. A copy of the inspection report shall be filed with the manufactured home community operator.
W. Va. Code R. § 64-40-7 Location, Space and Layout
7.1. General requirements.
7.1.a. Ground and paved surfaces in all parts of manufactured home communities shall be graded and equipped to drain all surface water in a safe and efficient manner.
7.1.b. The area of a manufactured home community shall be large enough to accommodate water supply systems and sewage treatment systems where applicable.
7.2. Space requirements.
7.2.a. Manufactured homes including their porches, canopies, and similar appurtenances, shall be separated from other manufactured homes and from other buildings and structures by the following spacing distances:
7.2.a.1. Ten (10) feet side to side;
7.2.a.2. Eight (8) feet end to side;
7.2.a.3. Six (6) feet end to end;
7.2.a.4. All accessory buildings or structures shall be located to meet the following spacing distances:
7.2.a.4.A. Three (3) feet from adjacent accessory building or structure, and
7.2.a.4.B. Five (5) feet from adjacent lot if constructed of combustible materials.
7.2.b. In no event shall any manufactured home site contain less than 3000 square feet or 4,500 square feet for double wide manufactured homes.
7.2.c. The owner of each manufactured home shall place a marker in a visible location on or near the manufactured home. The identification marker shall be clearly visible and at least four (4) inches in height.
7.2.d. An occupied manufactured home shall not be permitted in a manufactured home community, unless the manufactured home is situated on an approved manufactured home stand.
7.2.e. All manufactured homes shall be located at least fifteen (15) feet from any manufactured home community property boundary line abutting upon a public street or highway and at least ten (10) feet from other manufactured home community property boundary lines.
7.2.f. There shall be at least ten (10) feet of space between a manufactured home and any manufactured home community street, common parking area, or other common use areas.
7.3. Manufactured home stands. Manufactured home stands shall be maintained to prevent heaving, shifting, or uneven settling under the weight of the manufactured home due to frost action, drainage, vibration, or forces acting on the superstructure of the manufactured home.
7.4. Streets, roads and walkways. The manufactured home community operator shall maintain all streets, roads and walkways in good repair.
W. Va. Code R. § 64-40-8 Water Supply
8.1. General requirement.
8.1.a. All manufactured home communities shall be provided with an easily accessible, safe, supply of potable water, approved by the Commissioner.
8.1.b. All water supplies, water piping, fixtures or other equipment serving a manufactured home community shall be constructed, installed, maintained operated, and monitored in compliance with all applicable provisions of this rule and Bureau for Public Health legislative rules: Public Water Systems, 64CSR3; Water Well Regulations, 64CSR19; and Cross-Connection Control and Backflow Prevention Regulations, 64CSR15.
8.1.c. Drinking fountains, if provided, shall be constructed of easily cleanable impervious material, have an angle-jet nozzle protected by a nonoxidizing guard above the overflow rim of the bowl, be equipped with a pressure regulating device and shall be maintained in a sanitary manner.
8.2. Individual water riser pipes and water connections.
8.2.a. Each manufactured home site shall be served by a 3/4 inch in diameter or larger water riser pipe extending vertically at least four (4) inches above ground elevation.
8.2.b. Water riser pipe outlets shall be securely capped when a manufactured home does not occupy the manufactured home site.
W. Va. Code R. § 64-40-9 Sewage System
9.1. General requirements.
9.1.a. All manufactured home communities shall be served by a sewage collection and sewage treatment system that is in compliance with legislative rule, Sewer Systems, Sewage Treatment Systems and Sewage Tank Cleaners, 64CSR9.
9.1.b. All sewage collection or sewage treatment facilities shall be located, maintained, and operated in such a manner as to not create an insanitary condition or a nuisance to the manufactured home community occupants or to the owners or occupants of adjacent property.
9.1.c. All plumbing in the manufactured home community shall be in compliance with all applicable state and local plumbing laws, rules, ordinances and codes.
9.2. Individual sewer connections.
9.2.a. Each manufactured home site shall be provided with a sewer riser pipe having a minimum diameter of four (4) inches and extending at least four (4) inches above the ground.
9.2.b. The sewer riser pipe shall be located within the confines of the manufactured home site, and so located that the sewer connection to the manufactured home sewer outlet will approximate a vertical position.
9.2.c. The sewer riser pipe shall be at least ten (10) feet from the water riser pipe.
9.2.d. All materials used for sewer piping and sewer connections shall be durable, semi-rigid, corrosive resistant, and nonabsorbent. All joints shall be water tight.
9.2.e. Approved fittings shall be provided for the connection between the manufactured home community sewer riser pipe and the manufactured home sewer outlet, and shall be made water and odor tight by the use of approved reinforced, durable, impervious semi-rigid or flexible piping having smooth interior surfaces and not less than three (3) inches internal diameter.
9.2.f. The piping used for sewer connections shall be sealed to prevent odor and no longer than necessary to make the connection between the manufactured home sewer outlet and the manufactured home community sewer riser pipe.
9.2.g. Sewer riser pipes at unoccupied manufactured home sites shall be tightly plugged or capped in a manner that renders them water tight.
9.2.h. The manufactured home community operator shall keep all occupied manufactured homes properly connected to the sewer riser pipes while the manufactured homes are in the manufactured home community, and to see that all unoccupied manufactured home site sewer riser pipes are plugged or capped in an approved manner.
W. Va. Code R. § 64-40-10 Management Buildings and Other Community Service Facilities
10.1. Management buildings, if provided, shall include, but shall not be limited to the following community services as: management offices, repair shops, storage areas, and toilet, bathing, laundry, recreational and other auxiliary facilities supplying essential goods and services for the use of the manufactured home community occupants.
10.2. The Manufactured Home Community operator shall maintain all floors, walls, ceilings, and attached appurtenances and all fixtures and equipment clean and in good repair.
W. Va. Code R. § 64-40-11 Garbage and Refuse
11.1. The storage, collection, transportation, and/or disposal of garbage and refuse shall be conducted to prevent odor, rodents, insects and other nuisance conditions.
11.2. All garbage and refuse containers shall be covered when not in continuous use and maintained in a clean condition and in good repair.
11.3. A sufficient number and capacity of garbage and refuse containers shall be provided to residents to properly contain all waste.
11.4. If a central location is provided for garbage and refuse containers, the location shall be constructed of non-absorbent material, such as concrete or asphalt, shall be smooth, durable and sloped to drain and shall be of sufficient capacity to accommodate all containers.
11.5. All garbage and refuse shall be collected at an interval not to exceed seven (7) days.
11.6. Where approved municipal or private garbage and refuse disposal service is not available, the manufactured home community operator shall dispose of the garbage and refuse in accordance with applicable laws.
W. Va. Code R. § 64-40-12 Insect and Rodent Control
12.1. Grounds, common buildings, and structures shall be maintained free of insect breeding areas, rodent harborage, and infestation of insect or rodents of public health significance.
12.2. All exterior openings of management buildings or other applicable structures shall be effectively screened or insects and rodents excluded by other effective means.
W. Va. Code R. § 64-40-13 Fuel Supply and Storage
13.1. LPG systems (Liquefied Petroleum Gas) or fuel oil systems shall have at least one (1) approved, identified, and readily accessible means of shutting off the entire supply. Such means shall be located outside the manufactured home and shall be maintained in an effective operating condition.
13.2. LPG containers or fuel oil storage containers shall not be located within or beneath any manufactured home, building, or any other type of enclosed structure.
13.3. LPG containers or fuel oil storage containers shall not be located within 5 feet of a door way of a manufactured home, building, or similar structure.
W. Va. Code R. § 64-40-14 Registration of Occupants
14.1. Every manufactured home community operator shall maintain a record identifying manufactured homes and occupants permitted to use the manufactured home community.
14.2. The record of occupants shall be readily available to the health officer. The record shall be preserved for a period of one (1) year and shall contain the name, mailing address, and physical location of all manufactured home occupants.
W. Va. Code R. § 64-40-15 Supervision
15.1. The person to whom a permit to operate a manufactured home community is issued shall operate the manufactured home community in compliance with all applicable provisions of this rule, all other laws and regulations applicable thereto, and shall provide supervision to maintain the manufactured home community and its facilities and equipment in good repair and in a clean and sanitary condition.
15.2. A manufactured home shall not be occupied for dwelling purposes unless it is properly placed on an approved manufactured home site and is properly connected to water, sewage, and other essential utilities.
W. Va. Code R. § 64-40-16 Miscellaneous Requirements
16.1. The operator of a manufactured home community shall make available to the incoming occupants of the manufactured home community a copy of this rule to inform them of their duties and responsibilities under this rule.
16.2. The operator of the manufactured home community may adopt additional requirements of the manufactured home community occupants if the requirements are not in conflict with this rule.
16.3. Persons owning or in charge of a dog, cat or other pet animal shall comply with all applicable laws.
W. Va. Code R. § 64-40-17 Penalties
17.1. Any person who violates any provision of this rule shall be guilty of a misdemeanor and shall upon conviction be punished by a fine of not more than two hundred dollars ($200) or by imprisonment for not more than thirty (30) days or both fine and imprisonment.
17.2. Each day's failure to comply with any applicable provision of this rule shall constitutes a separate offense.
W. Va. Code R. § 64-40-18 Administrative Due Process
Those persons adversely affected by the enforcement of this rule desiring a contested case hearing to determine any rights, duties, interests or privileges shall do so in a manner prescribed in the West Virginia Bureau for Public Health’s Procedural Rule, Rules of Procedure for Contested Case Hearings and Declaratory Rulings, 64CSR1.
64CSR40
64CSR40
Series 42 Childhood Lead Screening
W. Va. Code R. § 64-42-1 General
1.1. Scope. -- This rule establishes and implements a statewide childhood lead poisoning screening and identification program.
1.2. Authority. -- W. Va. Code §16-1-4 and §16-35-4a.
1.3. Filing Date. -- April 4, 2022.
1.4. Effective Date. -- April 4, 2022.
1.5. Sunset. -- This rule shall terminate and have no further force or effect on August 1, 2027.
W. Va. Code R. § 64-42-2 Application and Enforcement
2.1. This rule applies to all physicians, hospitals, health care facilities, and health care providers who conduct or oversee medical examinations of children under the age of six years.
2.2. Enforcement -- This rule is enforced by the Commissioner of the Bureau for Public Health.
W. Va. Code R. § 64-42-3 Definitions
3.1. Bureau. -- The West Virginia Bureau for Public Health.
3.2. Commissioner. -- The Commissioner of the Bureau for Public Health.
3.3. Elevated Blood Lead Level. -- A concentration of lead in the blood stream as defined in U.S. Department of Health and Human Services, Centers for Disease Control and Prevention Advisory Committee on Childhood Lead Poisoning Prevention, Low Level Lead Exposure Harms Children: A Renewed Call for Primary Prevention (2012).
3.4. Health Care Provider. -- A physician, or his or her designee, at any medical facility, including but not limited to, private clinics, health departments, and hospitals.
3.5. Laboratory. -- A facility or place, however, named, for the biological, microbiological, serological, chemical, immuno-hematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of human beings and is participating in the CDC blood lead laboratory proficiency program.
3.6. Screening. -- The assessment of a child’s environment and social conditions to determine risk for lead poisoning.
3.7. Screening test. -- A procedure using a blood sample to detect lead poisoning levels.
W. Va. Code R. § 64-42-4 Protocol for Screening of Children
4.1. West Virginia health care providers shall conduct a screening test on all children before the age of six years for risk of elevated blood lead levels in accordance with the recommendations contained in: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention Advisory Committee on Childhood Lead Poisoning Prevention, Low Level Lead Exposure Harms Children: A Renewed Call for Primary Prevention (2012); Council on Environmental Health, Prevention of Childhood Lead Toxicity, Pediatrics, 138(a), e20161493 (2016).
4.1.1. All children shall receive a screening test at one year and again at two years of age, and children 36 to 72 months of age if they have not been screened previously; and
4.1.2. The screening tests shall be recorded in each child’s medical record at the health care provider’s office. The Office of Maternal, Child and Family Health shall ensure laboratory results received are incorporated in the Immunization Registry within the Lead Module provided by the Bureau for Public Health for health care provider reference. This information shall include the date of screening test, the child’s address, the location where the screening test was conducted, which screening test was used, and the physician’s name.
4.2. The protocol for confirmation of elevated blood lead levels shall be in accordance with the U.S. Department of Health and Human Services, Centers for Disease Control and Prevention Advisory Committee on Childhood Lead Poisoning Prevention, Low Level Lead Exposure Harms Children: A Renewed Call for Primary Prevention (2012).
W. Va. Code R. § 64-42-5 Follow-up Testing and Information
5.1. In addition to the follow-up testing prescribed in W. Va. Code §16-35-4a, when a child’s results are confirmed as an elevated blood lead level, the Bureau for Public Health shall advise pregnant women residing at the same address of the need to be tested as soon as possible.
5.2. The health care provider shall provide all information concerning a child’s blood-lead level to the legal parent or guardian and other agencies involved in lead poisoning testing.
5.3. The Bureau shall refer children with elevated blood-lead levels to the following services:
5.3.1. Children with confirmed blood lead levels of greater than or equal to five micrograms per deciliter shall be referred to appropriate programs based on age and concern offered by the Office of Maternal, Child and Family Health in the Bureau, within 10 days of confirmation;
5.3.2. Children with two consecutive blood lead levels of greater than or equal to eight micrograms per deciliter shall be referred to the Bureau for an environmental investigation of the home to identify potential sources of lead within two days of confirmation; and
5.3.3. All children with elevated blood lead levels of greater than or equal to five micrograms per deciliter shall have a follow-up blood lead level screening test within three months as set forth in the U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, Recommended Actions Based on Blood Lead Level (2018); Council on Environmental Health, Prevention of Childhood Lead Toxicity, Pediatrics, 138(1), e20161493 (2016); and American Academy of Pediatrics, Prevention of Childhood Lead Toxicity, Pediatrics, 145(6) (2020).
W. Va. Code R. § 64-42-6 Reporting Requirements
6.1. The Bureau shall review this program at least every three years and make available to all interested parties a summary of the quarterly testing results, beginning in July of the effective year of this rule.
W. Va. Code R. § 64-42-7 Samples Submitted to a Laboratory
7.1. The health care provider shall submit all blood samples to a laboratory for analysis. Capillary blood samples may be analyzed using an approved Clinical Laboratory Improvement Amendments waived lead testing point of care system.
7.2. When submitting blood samples, the health care provider shall include a laboratory requisition obtained from the Bureau that contains the child’s name, address, the county of residence, the name and address of the physician who completed the screening test, and other information requested on the form.
7.3. Laboratories processing blood lead samples for analysis shall electronically submit all required data to the Bureau within seven working days of analysis, or sooner if available in accordance with 64CSR7.
W. Va. Code R. § 64-42-8 Confidentiality
8.1. Records received and information assembled by the Bureau are confidential medical records and shall not be disclosed except as permitted by law.
8.2. Reports published using statistical compilations relating to childhood lead poisoning may not in any manner identify individual patients, individual addresses, or individual enforcement action, or be reported for such small geographic areas or other categories with few entries that a person could, with other publicly available information, reasonably be able to identify the patients.
W. Va. Code R. § 64-42-9 Enforcement Action
9.1. The Commissioner may investigate all suspected violations of this rule or of W. Va. Code §§16-35-1 et seq., and upon the finding of a violation in connection with this rule, the Commissioner shall initiate appropriate enforcement action.
W. Va. Code R. § 64-42-10 Penalties
10.1. Any person who violates the provisions of W. Va. Code §16-35-4a or this rule is subject to the penalties provided in W. Va. Code §16-1-17 and §16-35-13.
W. Va. Code R. § 64-42-11 Administrative Due Process
11.1. Those individuals adversely affected by the enforcement of this rule desiring a contested case hearing to determine any rights, duties, interests, or privileges shall do so in a manner prescribed in the Rules and Procedures for Contested Case Hearing and Declaratory Ruling, 64CSR1.
64CSR42
64CSR42
Series 43 Food Manufacturing Facilities
W. Va. Code R. § 64-43-1 General
1.1. Scope. -- This legislative rule establishes the minimum requirements for the design, construction, management, and operation of food manufacturing facilities.
1.2. Authority. -- W. Va. Code §16-1-4 and §16-7-1.
1.3. Filing Date. -- April 4, 2022.
1.4. Effective Date. -- May 31, 2022.
1.5. Sunset Provision. -- This rule shall terminate and have no further force or effect on upon August 1, 2027.
1.6. Applicability. -- This rule applies to the owners and operators of food manufacturing facilities engaged in wholesale operations. Food manufacturing facilities under the jurisdiction of the West Virginia Department of Agriculture are not subject to this rule.
1.7. Enforcement. -- This rule is enforced by the commissioner of the bureau for public health.
W. Va. Code R. § 64-43-2 Definitions
2.1. Acidified foods. -- Low-acid foods to which acid(s) or acid food(s) are added. These foods include, but are not limited to, beans, cucumbers, cabbage, artichokes, cauliflower, puddings, peppers, tropical fruits, and fish, singly or in any combination. They have a water activity (aw) greater than 0.85 and have a finished equilibrium pH of 4.6 or below. These foods may be called, or may purport to be, “pickles” or “pickled.'' Carbonated beverages, jams, jellies, preserves, acid foods (including such foods as standardized and non-standardized food dressings and condiment sauces) that contain small amounts of low-acid food(s) and have a resultant finished equilibrium pH that does not significantly differ from that of the predominant acid or acid food, foods that are stored, distributed, and retailed under refrigeration, and fermented are excluded.
2.2. Better process control school. -- A course recognized by the Food and Drug Administration (FDA) to meet the requirements of 21 CFR 113.10 and 21 CFR 114.10.
2.3. Commissioner. -- Commissioner of the bureau for public health or his or her designee.
2.4. Food Manufacturing Facility. -- Any person that manufactures, processes, or packs food for human consumption and conducts wholesale operations. This term does not include: farms, facilities regulated by legislative rule 64CSR17, “Food Establishments,” and facilities under the regulatory authority of the West Virginia department of agriculture.
2.5. Low-acid foods. -- Any foods, other than alcoholic beverages, with a finished equilibrium pH greater than 4.6 and a water activity (aw) greater than 0.85. Tomatoes and tomato products having a finished equilibrium pH less than 4.7 are not classed as low-acid foods.
2.6. Permit. -- A document issued by the commissioner to operate a food manufacturing facility.
2.7. Person. -- Individual, partnership, association, syndicate, company, firm, trust, corporation, government corporation, institution, department, division, bureau, agency, or any entity recognized by law.
2.8. Preventative controls qualified individual. -- An individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standard curriculum recognized as adequate by the food and drug administration or is otherwise qualified through job experience to develop and apply a food safety system.
2.9. Processing Authority. -- A person who has been recognized by the association of food and drug officials as having expert knowledge of thermal processing requirements for low-acid foods packaged in hermetically-sealed containers or has expert knowledge in the acidification and processing of acidified foods and is found in the food processing authorities directory at: https://www.afdo.org/directories/fpa/.
2.10. Very small business. -- A business (including any subsidiaries and affiliates) averaging less than $1,000,000 per year, adjusted for inflation, during the three-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed, or held without sale.
2.11. Wholesale. -- The sale or distribution of food to other business entities such as, but not limited to, retail stores, other food manufacturers, or food establishments.
W. Va. Code R. § 64-43-3 Incorporation by Reference of the Federal Code of Regulations
3.1. The following portions of Title 21 of the Code of Federal Regulations, as amended October 6, 2021, are incorporated by reference:
3.1.1. 21 CFR 117, current good manufacturing practice, hazard analysis, and risk based preventive controls for human food with the following exceptions:
3.1.1.a. 21 CFR 117.5;
3.1.1.b. 21 CFR 117.7;
3.1.1.c. 21 CFR 117.8; and
3.1.1.d. 21 CFR 117, Subparts C and G shall not apply to facilities defined as a very small business, which shall comply with the requirements set forth in 21 CFR 117, Subpart D.
3.1.2. 21 CFR 113, thermally processed low acid foods packaged in hermetically sealed containers; and
3.1.3. 21 CFR 114, acidified foods.
W. Va. Code R. § 64-43-4 General Requirements
4.1. Whenever a food manufacturing facility is constructed or altered and whenever an existing structure is converted to a food manufacturing facility, plans and specifications for such construction, altering, or conversion shall be submitted to the commissioner for review and approval at least 45 days prior to the date the person intends to engage in business.
4.2. Facilities shall not begin manufacturing, processing, or packing food for human consumption until the facility has obtained or completed:
4.2.1. A permit to operate from the commissioner, as required in section 5 of this rule;
4.2.2. Label approval for all products from the West Virginia Department of Agriculture, and which complies with food labelling requirements of 21 CFR 101 for products sold in interstate commerce; and
4.2.3. Registration with the FDA under the Public Health Security and Bio-Terrorism and Preparedness and Response Act of 2002. Exemptions shall be determined by the FDA.
4.3. Facilities shall also comply with requirements set forth in the Code of Federal Regulations incorporated by reference in section 3 of this rule regarding processing authority, better process control school, process control qualified individual training, and appropriate food safety training prior to manufacturing, processing, or packing food for human consumption.
4.4. All facilities governed by this rule shall maintain process records, have a written recall procedure, and flow charts of products. These documents shall be readily available to the commissioner.
4.5. If living or sleeping quarters are located on the premises, they shall be separated from rooms and areas used for food manufacturing facilities with complete partitioning and solid self-closing doors.
W. Va. Code R. § 64-43-5 Permits
5.1. No person shall operate a food manufacturing facility within the State of West Virginia who does not possess a valid permit issued by the commissioner.
5.2. An application for a permit to operate a food manufacturing facility shall be made in writing to the commissioner on a form prescribed by the commissioner.
5.3. A person shall apply for a permit at least 15 days before the date that the current permit expires or within 45 days of the date before the actual or proposed operation of the facility is to be affected.
5.4. Permits shall not be transferable and shall become invalid upon a change of ownership.
5.5. A permit to operate expires at midnight on the 30th day of June following the date of issuance.
5.6. The commissioner may, without warning, notice, or hearing suspend a permit to operate a food manufacturing facility if the permit holder:
5.6.1. Does not comply with the requirements of this rule or if the operation of the food manufacturing facility constitutes an imminent public health hazard; or
5.6.2. The permit holder has been determined by the commissioner to have obstructed or hindered the commissioner in the proper discharge of his or her duties.
5.7. Operational permits shall be posted within the food manufacturing facility and be readily available to the commissioner.
W. Va. Code R. § 64-43-6 Inspections
The commissioner shall conduct one or more preproduction inspections to verify that a food manufacturing facility is constructed and equipped in accordance with the plans and modifications as approved by the commissioner and shall otherwise conduct as many inspections as necessary to assure compliance with this rule.
W. Va. Code R. § 64-43-7 Implementation
7.1. Food manufacturing facilities in operation at the time this rule becomes effective, and meet Section 3 of this rule, are considered eligible for a permit to operate provided that any construction done after the effective date of this rule is in compliance with this rule.
7.2. New or extensively remodeled food manufacturing facilities whose plans and specifications received written approval from the commissioner prior to the effective date of this rule are eligible for a permit to operate provided that the construction or remodeling is in compliance with the approved plans.
W. Va. Code R. § 64-43-8 Fees
All facilities governed by this rule are subject to the appropriate fees established by 64CSR51.
W. Va. Code R. § 64-43-9 Administrative Due Process
Any person adversely affected by the enforcement of this rule desiring a contested case hearing to determine any rights, duties, interests, or privileges shall do so in the manner prescribed in 64CSR1.
W. Va. Code R. § 64-43-10 Penalty for Violating Provisions of Rule
Any persons violating the provisions of this rule or orders pursuant to this rule is subject to the penalties provided in W. Va. Code §16-1-18 and §16-7-4.
64CSR43
64CSR43
Series 45 Lead Abatement Licensing
W. Va. Code R. § 64-45-1 General
1.1. Scope. - This legislative rule establishes procedures and standards for the licensure and training of persons who engage in activities related to lead abatement and for the operation of lead abatement projects. This rule should be read in conjunction with the definitions and provisions of W. Va. Code §16-35-1 et seq. (Lead Abatement).
1.2. Authority -- W. Va. Code §16-1-4 and §16-35-4.
1.3. Filing Date. -- April 13, 2026.
1.4. Effective Date. -- July 1, 2026.
1.5. Sunset Provision. -- This rule shall terminate and have no further force or effect upon August 1, 2031.
W. Va. Code R. § 64-45-2 Application and Enforcement
2.1. Application. -- This rule applies to persons who conduct lead abatement projects in target housing or child-occupied facilities, and requires licensure of lead contractors, inspectors, risk assessors, workers, supervisors, and designers.
2.2. Enforcement. -- This rule shall be enforced by the commissioner of the West Virginia Bureau for Public Health.
W. Va. Code R. § 64-45-3 Definitions
3.1. Abatement. -- Any measure or set of measures designed to permanently eliminate lead-based paint hazards. Abatement includes, but is not limited to:
3.1.1. The removal of lead-based paint and lead-contaminated dust, the permanent containment or encapsulation of lead-based paint, the replacement of lead-painted surfaces or fixtures, and the removal or covering of lead-contaminated soil;
3.1.2. All preparation, cleanup, disposal, and post-abatement clearance testing activities associated with such measures;
3.1.3. Projects for which there is a written contract to permanently eliminate lead-based paint hazards from a dwelling unit or child-occupied building;
3.1.4. Projects involving the permanent elimination of lead-based paint or lead contaminated soil;
3.1.5. Projects involving the permanent elimination of lead-based paint hazards or lead contaminated soil that are conducted by persons who advertise or hold themselves out to conduct lead related activities; and
3.1.6. Projects involving the permanent elimination of lead-based paint hazards that are conducted in response to federal, state, or local abatement orders.
3.2. EPA. -- The United States Environmental Protection Agency.
3.3. HEPA. -- High efficiency particulate air.
3.4. Lead abatement contractor. -- A person engaged by oral or written contract to perform a lead abatement project.
3.5. Lead-based paint. -- Paint or other surfacing coatings that contain lead at or in excess of 5000 parts per million, or 0.5% by weight, or 1.0 mg/cm2.
3.6. Lead-contaminated dust. -- Surface dust containing lead at any reportable level per square foot for floors; at any reportable level per square foot for interior window sills; and at any reportable level per square foot for window troughs and exterior concrete or other rough surfaces.
3.7. Lead-contaminated soil. -- Soil containing lead at or in excess of 1200 parts per million, or 400 parts per million for bare, high-contact play areas.
3.8. Lead-contaminated waste. -- Any discarded materials with lead toxicity equal to or in excess of five parts per million as determined by the total characteristic leachate procedure (TCLP).
3.9. License. -- A document authorizing an individual to perform specific lead abatement activities.
3.10. Public building. -- Any building that is generally open to the public, including but not limited to, museums, airport terminals, hospitals, stores, restaurants, convention centers and other office buildings, corporate facilities, and government buildings that do not expressly prohibit access to the public.
3.11. Target Housing. -- Residential structures built prior to 1978 or residential structures that are confirmed by inspection to contain lead-based paint.
3.12. XRF analyzer. -- An instrument that determines lead concentration in milligrams per square centimeter (mg/cm5) using the principle of x-ray fluorescence (XRF).
W. Va. Code R. § 64-45-4 Initial and Renewal License
4.1. Initial license.
4.1.1. Applicants for licensure as a lead inspector, risk assessor, worker, supervisor, designer, or contractor shall submit to the commissioner an application which shall include:
4.1.1.a. Proof of passage of an applicable state accredited lead training course. A copy of the certificate indicating the date on which training was completed, the location at which training was conducted, the signature of the instructor, and examination score is required;
4.1.1.b. Proof of passage of an examination from a state accredited discipline examiner for the license discipline. A copy of the examination certificate indicating the applicant’s name, the date on which the examination took place, the location of the examination, the license discipline, and the score of the examination is required;
4.1.1.c. The applicant’s date of birth, social security number, current address, driver’s license number, and telephone phone number. Applicants shall be at least 18 years of age;
4.1.1.d. The signature of the applicant;
4.1.1.e. A history of all environmental enforcement actions taken against the applicant by any federal or state agency or court;
4.1.1.f. Attachment of all applicable license fees. A schedule of fees is set forth in Table A of this rule;
4.1.1.g. Evidence that an applicant for a lead supervisor license has one year of experience as a lead abatement worker, or at least two years of experience in a related field, such as lead, asbestos, or environmental remediation work, or the building trades;
4.1.1.h. Evidence that an applicant for a lead risk assessors license possesses a valid lead inspector’s license and one of the following:
4.1.1.h.1. A bachelor’s degree and one year of experience in a related field, such as lead, asbestos, environmental remediation work, or construction;
4.1.1.h.2. An associates degree and two-years of experience in a related field such as lead, asbestos, environmental remediation work, or construction;
4.1.1.h.3. A certification as an industrial hygienist, professional engineer, registered architect, registered sanitarian, or certification in a related engineering/ health/environmental field, such as safety professional, environmental scientist; or
4.1.1.h.4. A high-school diploma or equivalent, and at least three years of experience in a related field, such as lead, asbestos, environmental remediation work, or construction;
4.1.1.i. Evidence that an applicant for a project designer license:
4.1.1.i.1. Possesses a bachelor’s degree in engineering, architecture, or a related profession and one year of experience in building construction and design or a related field; or
4.1.1.i.2. Four years of experience in building construction and design or a related field; and
4.1.1.i.3. Proof of passage of a lead supervisor training course;
4.1.1.j. Evidence that an applicant for a contractor license has a licensed supervisor on staff.
4.1.2. Applicants and their employers or agents shall demonstrate to the satisfaction of the commissioner that the applicant is familiar with and capable of complying fully with all applicable requirements, procedures, and standards of the EPA, Occupational Safety and Health Administration (OSHA), and of the West Virginia Bureau for Public Health, the West Virginia Division of Natural Resources, the West Virginia Department of Commerce, the West Virginia Division of Labor, the West Virginia Air Quality Board, and the West Virginia Department of Environmental Protection covering any part of a lead abatement project. An applicant who has passed an applicable state accredited training course and passed an examination from a discipline examiner meets this requirement.
4.1.3. The commissioner may deny a license and retain the license fee if the applicant fails to satisfy the requirements of this section. A written notice of denial and an opportunity for reapplication shall be afforded to all applicants.
4.1.4. Licenses issued under this rule expire one year from the last day of the month in which they were issued.
4.2. Renewal application.
4.2.1. Prior to the expiration date shown on the license, each licensee who desires to retain a valid license shall submit a renewal application, appropriate refresher course certification, and all applicable fees. Licensees should apply for renewal no less than 10 days prior to the expiration of the license to avoid a temporary lapse of license. A schedule of license fees is set forth in Table A of this rule.
4.2.2. Applicants shall submit proof of passage of an applicable state accredited refresher course every third year from the date of the original training and certification.
W. Va. Code R. § 64-45-5 Licensed Lead Abatement Contractor Duties
5.1. A licensed lead abatement contractor shall:
5.1.1. Ensure that each contractor’s employees or agents who will come into contact with lead or who will be responsible for a lead abatement project are properly licensed;
5.1.2. Ensure that each lead abatement project is supervised by an on-site licensed lead supervisor;
5.1.3. Notify the Bureau for Public Health and all other entities as may be required by state or federal law at least 10 days prior to the commencement of each lead abatement project. Notification to the Bureau for Public Health shall be by certified mail or by hand-delivery to the Bureau for Public Health;
5.1.4. Ensure that a lead abatement project is designed by a licensed lead abatement designer;
5.1.5. Ensure that each lead abatement project meets the minimum clearance standards as set forth in section 11 of this rule;
5.1.6. Ensure proper disposal of lead contaminated waste in accordance with applicable federal, state, and local laws, rules, and regulations;
5.1.7. Keep a record of each lead abatement project. The records shall include:
5.1.7.a. The name, address, and lead abatement license number of the individual who supervised the lead abatement project and of each employee or agent who worked on the project;
5.1.7.b. The location and a description of the lead abatement project and the amount of lead material that was removed;
5.1.7.c. The starting and completion dates of each lead abatement project and a summary of the procedures that were used to comply with all federal and state standards;
5.1.7.d. The name and address of each disposal site where waste containing lead was deposited and the disposal site receipts. Contractors shall use disposal sites which are in conformance with applicable federal, state, and local laws and regulations; and
5.1.7.e. The clearance sample results or air monitoring results required by section 11 of this rule for each lead abatement project. The records shall include:
5.1.7.e.1. The name and signature of the lead inspector who collected the clearance samples;
5.1.7.e.2. Where the samples were collected;
5.1.7.e.3. The date of collection;
5.1.7.e.4. The name and address of all laboratories analyzing the samples;
5.1.7.e.5. The date of analysis;
5.1.7.e.6. The results of analysis;
5.1.7.e.7. The method of analysis;
5.1.7.e.8. The name and signature of the person performing the analysis; and
5.1.7.e.9. Certification that the laboratory is EPA certified to analyze lead samples.
5.2. The records required by this section shall be available to the Bureau for Public Health, Division of Natural Resources, Department of Environmental Protection, Division of Labor, and Air Quality Board upon request during normal business hours. Records for current projects shall be immediately available. For completed projects, the commissioner may afford the contractor a reasonable time to comply with the requests, depending upon the length of time since the project’s completion and whether or not the advance notice might adversely affect an investigation being conducted by any of the agencies. Records required by this section shall be kept for at least three years.
W. Va. Code R. § 64-45-6 Lead Inspector Duties
6.1. A licensed lead inspector shall:
6.1.1. Thoroughly inspect interior and exterior surfaces suspected of containing lead that may be affected by renovation or demolition and sample the materials for lead content or confirm lead content with an XRF analyzer.
6.1.2. Generate a written report that at a minimum:
6.1.2.a. Identifies by narrative any sampling location where the presence of lead containing material has been confirmed;
6.1.2.b. Details the location and amount of all materials that contain lead;
6.1.2.c. Lists analysis, XRF results, or both for all samples;
6.1.2.d. Includes drawings and narrative descriptions of locations of samples and/or XRF readings; and
6.1.2.e. Includes a statement that the inspection is not a risk assessment.
6.1.3. Adequately sample each area or room of an abatement project for clearance to verify that dust, soil, and waste material lead levels are below the contamination standards as defined in subsections 3.6, 3.7 and 3.8 of this rule.
W. Va. Code R. § 64-45-7 Lead Abatement Designer Duties
7.1. A licensed lead abatement designer shall generate a written report that provides:
7.1.1. A chronological time frame for each facet of the abatement activity;
7.1.2. The name and address of the building or structure where the lead abatement project is to occur;
7.1.3. The name, address, phone number, and lead abatement training certificates and licenses for the project designer;
7.1.4. A schematic floor plan showing the lead abatement project area, including a description of the characteristics of the material;
7.1.5. A statement identifying the abatement activity as repair, removal, encapsulation, or enclosure;
7.1.6. A schematic floor plan of the project area which shows the physical dimensions, entrance, exit, windows, decontamination unit, load-out area, emergency exits, placement of the HEPA exhaust air filtration units, if applicable, and any measuring devices, warning signs, and barrier tape;
7.1.7. The sampling protocol for project clearance for re-occupancy, including the number of samples, collection points, and the analytical method to be employed;
7.1.8. A schematic of the heating, ventilation, and air-conditioning system shut-offs; electrical power; water source; fire exits; fire extinguisher; fire alarm; telephone; tool and equipment room; supply box; project field office; bathrooms; and decontamination area;
7.1.9. A description of the work procedures to be used;
7.1.10. A description of the materials and tools to be used in the abatement project; and
7.1.11. An occupant protection plan in accordance with subsection 16.1 and 16.4 of this rule.
W. Va. Code R. § 64-45-8 Lead Risk Assessor Duties
8.1. A licensed lead abatement risk assessor shall generate a written risk assessment report that provides:
8.1.1. Background information regarding the age, condition, and physical characteristics of the structure and residential use patterns;
8.1.2. A schematic site plan showing each room within the structure, its use, and the location and condition of lead-based paint;
8.1.3. A copy of any previous test results or inspections regarding lead-based paint or other assessments for lead hazards;
8.1.4. An assessment of the potential routes of lead exposure for occupants or lead abatement professionals, which is based upon adequate dust, water, soil, and paint chip sampling; and
8.1.5. A detailed description of recommended control strategies for reducing lead-based paint hazards and justification for the strategy selected, the locations where the recommended actions should take place, and a suggested prioritization for taking each action based on the degree of the hazard.
8.2. The risk assessment shall be maintained by the risk assessor or his or her firm for a period of three years.
W. Va. Code R. § 64-45-9 Prohibited Lead Abatement Project Methods
9.1. The following lead abatement project methods are prohibited:
9.1.1. The use of open flame burning, torching, fossil fuel-powered heat plates, welding, cutting torches, and heat guns operating at temperatures greater than 1,100 degrees F as a means of lead-based paint removal;
9.1.2. Uncontained machine sanding or grinding;
9.1.3. Uncontained hydro-blasting and high-pressure water washing;
9.1.4. Uncontained abrasive blasting or sandblasting;
9.1.5. Chemical paint removers that contain methylene chloride; and
9.1.6. Dry scraping lead-based paint, except for areas around electrical outlets.
W. Va. Code R. § 64-45-10 Recommended Lead Abatement Project Methods
10.1. The following lead abatement project methods are recommended:
10.1.1. Electric-powered flameless heat guns operating below 1,100 degrees F, provided that proper respiratory protection is used;
10.1.2. Mechanical HEPA sanding, HEPA vacuum blasting, and HEPA vacuuming needle guns;
10.1.3. Wet scraping, provided that no electrical hazards are present while doing so;
10.1.4. The removal of building components to be stripped of lead-based paint off site: Provided, That dust generation during the removal and transportation of the building components is kept to a minimum;
10.1.5. Chemical removal methods which do not contain methylene chloride: Provided, That product material safety data sheet recommendations for safety and OSHA regulations are implemented;
10.1.6. The enclosure of building components that contain lead-based paint, provided that the enclosure material becomes a permanent part of the building structure and is properly sealed to ensure that lead dust is permanently contained;
10.1.7. Encapsulation of lead-based paint, provided that the encapsulating material becomes a permanent part of the building component and will be guaranteed by the lead abatement company and manufacturer from defect for a minimum of 20 years; and
10.1.8. Total removal of lead-contaminated soil or the covering of lead-contaminated areas with a suitable material that will limit exposure. For purposes of this subdivision, suitable material includes but is not limited to stone, pavement, gravel, or vegetative cover.
W. Va. Code R. § 64-45-11 Lead Abatement Project Clearance Levels and Minimum Sampling
11.1. A licensed lead inspector shall conduct a visual inspection at the conclusion of a lead abatement project and collect samples as set forth in Table D of this rule.
11.2. A lead abatement project shall be ready for occupation when the following clearance levels of lead are obtained:
11.2.1. Below five micrograms of lead per square foot for interior floors or other horizontal surfaces;
11.2.2. Below 40 micrograms of lead per square foot for interior window sills;
11.2.3. Below 100 micrograms of lead per square foot for window troughs and exterior concrete or other rough surfaces;
11.2.4. Below 400 parts per million for bare soil areas that are child play areas;
11.2.5. Below 1200 parts per million for residential bare soil areas; and
11.2.6. A total characteristic leachate procedure (TCLP) below five parts per million lead toxicity for discarded building materials.
11.3. The minimum numbers of samples to be obtained from a lead abatement project area are defined in Table D of this rule.
11.4. In addition to the required number of samples as defined in Table D of this rule, a licensed lead inspector will obtain one soil sample for each 400 square feet of bare soil area of a lead abatement project and one composite sample from homogeneous building materials that is representative of the waste stream.
W. Va. Code R. § 64-45-12 Exemption from Notification and Licensing
12.1. Exemptions from notification and licensure are provided in W. Va. Code §6-35-7.
W. Va. Code R. § 64-45-13 Notification of Elevated Blood Lead Levels
13.1. Any person, contractor, or laboratory shall notify the commissioner of any medically confirmed elevated blood-lead levels within 36 hours of discovery.
W. Va. Code R. § 64-45-14 Notification of Lead Abatement Projects
14.1. Each owner or other person responsible for the operation of a building, facility, residence, or structure where a lead abatement project is to occur shall notify the division 10 days prior to commencement of the project and pay the notification fee set forth in Table B of this rule.
W. Va. Code R. § 64-45-15 Accreditation or Reaccreditation of Lead Abatement Initial or Refresher Training Courses
15.1. Applicants for accreditation or reaccreditation as lead abatement training providers shall submit the following:
15.1.1. The name, address, and telephone number of the lead training provider;
15.1.2. A full description of the course curriculum;
15.1.3. A list of instructors, their resumes, and qualifications;
15.1.4. A copy of the course examination;
15.1.5. The annual lead training course accreditation fee set forth in Table C of this rule;
15.1.6. Any additional information required by W. Va. Code §16-35-10; and
15.1.7. All applications or certifications required by the commissioner.
15.2. Initial or refresher lead abatement training providers to be accredited or reaccredited by the Bureau for Public Health shall comply with subsections 16.1 and 16.4 of this rule including, but not limited to curriculum, length of training, record keeping, and training manager and instructor qualifications.
W. Va. Code R. § 64-45-16 Applicable Federal Standards
All individuals licensed under this rule shall comply with the following applicable federal standards, which are hereby incorporated in this rule by reference:
16.1. EPA: Lead; Requirements for Lead-Based Paint Activities in Target Housing and Child-Occupied Facilities: Final Rule. 40 CFR Part 745.227 (September 29, 2025);
16.2. OSHA: Lead Exposure in Construction; Final Rule. 29 CFR 1926.62 (September 26, 2025);
16.3. HUD: Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing (July 2012); and
16.4. EPA: Lead; Requirements for Lead-Based Paint Activities in Target Housing and Child-Occupied Facilities; Final Rule. 40 CFR Part 745.225 (b),(c),(d),(e),(f),(g),(h),(i) (September 29, 2025).
W. Va. Code R. § 64-45-17 Penalties
17.1. The commissioner may, depending upon the severity of the violation and upon the degree of health hazard created, suspend or revoke the license of a contractor, inspector, designer, risk assessor, supervisor, or worker if the licensee:
17.1.1. Fraudulently or deceptively obtains or attempts to obtain a license;
17.1.2. Fails at any time to meet the qualifications for license or fails to comply with the requirements of W. Va. Code §16-35-1 et seq. or this rule;
17.1.3. Knowingly falsifies or attempts to falsify documents related to a lead abatement project or license;
17.1.4. Fails to meet the applicable federal or state standard for lead abatement; or
17.1.5. Fails to remit an assessed civil penalty or fine.
17.2. The commissioner may suspend or revoke the accreditation or reaccreditation of an initial or refresher lead training provider if the training provider fails to meet the requirements of this rule as outlined in subsections 16.1 and 16.4.
17.3. The commissioner may investigate all alleged violations of this rule or of W. Va. Code §16-35-1 et seq. reported to the Bureau for Public Health. Upon the finding of a violation in connection with a lead abatement project the commissioner shall, depending upon the severity of the violation and upon the degree of health hazard created, initiate an appropriate enforcement action which may include the issuance of a cease and desist order directing that all work on the project be halted immediately. Posting of the cease and desist order on the project site constitutes notice of its contents to the property owner and all individuals working on the lead abatement project. Where practicable, however, the commissioner shall deliver a copy of the order by certified mail, return receipt requested, to the property owner and to the contractor.
17.4. Fines and penalties are as provided in W. Va. Code §16-35-13.
W. Va. Code R. § 64-45-18 Administrative Due Process
18.1. Those individuals adversely affected by the enforcement of this rule desiring a contested case hearing to determine any rights, duties, interests or privileges shall do so in a manner prescribed in the Bureau for Public Health’s legislative rule, Rules and Procedures for Contested Case Hearings and Declaratory Rulings, 64CSR1.
W. Va. Code R. § 64-45-19 Severability
19.1. Each of the hazard standards and clearance levels for lead in paint and dust promulgated by the United States Environmental Protection Agency under 40 C.F.R. part 745 (September 29, 2025); and adopted and incorporated by reference under subsections 16.1. and 16.4. are severable.
19.2. The safety and health regulations for construction promulgated by the United States Occupational Safety and Health Administration under 29 C.F.R. part 1926 (September 26, 2025) and adopted and incorporated by reference under subsection 16.2. are severable.
19.3. In the event any hazard standards and clearance levels for lead in paint and dust promulgated by the United States Environmental Protection Agency under 40 C.F.R. part 745 and adopted and incorporated by reference under subsections 16.1. and 16.4. is withdrawn by the EPA, is invalidated by a court of competent jurisdiction in a final action after the last appeal deadline, and/or is invalidated by an act of the United States Congress, such provision is severed from 64CSR45 after the effective date of the withdrawal or invalidation and is no longer adopted and incorporated by reference under subsections 16.1. and 16.4.
19.4. In the event any safety and health regulations for construction promulgated by the United States Occupational Safety and Health Administration under 29 C.F.R. part 1926 and adopted and incorporated by reference under subsection 16.2. is withdrawn by OSHA, is invalidated by a court of competent jurisdiction in a final action after the last appeal deadline, and/or is invalidated by an act of the United States Congress, such provision is severed from 64CSR45 after the effective date of the withdrawal or invalidation and is no longer adopted and incorporated by reference under subsection 16.2.
19.5. In the event any provision is severed in accordance with subsections 19.3. or 19.4., the commissioner shall file an emergency rule.
TABLE 65-45 A
LICENSE FEES
Type of License Fee Worker $100 Supervisor $150 Inspector $150 Risk Assessor $150 Project Designer $150 Contractor $400 TABLE 65-45 B NOTIFICATION FEE All Projects $60.00 TABLE 65-45 C ACCREDITATION FEES FOR LEAD TRAINING PROVIDERS Initial Accreditation $1,000.00 per Discipline (max. $3,000.00)
Annual Reaccreditation $500.00 per Discipline (max. $1,500.00)
TABLE 64-45 D
MINIMUM NUMBER AND LOCATION OF SINGLE-SURFACE DUST SAMPLES
Clearance Category Category Description Number and location of Single-Surface Wipe Samples in Each Area Number and Location of Composite Wipe Samples Interior treatments No containment within dwelling Two dust samples from at least four rooms in dwelling (treated or untreated): One interior window sill or window trough, alternating between rooms. One floor.
AND For common areas, one for every 2,000 ft of a common area room floor (if present)
Three composite samples for every batch of four rooms (whether treated or untreated): One floor composite. One interior window sill composite One window trough composite.
AND For common areas, one floor subsample for every 2,000 ft (if present); up to 8,000 ft can be sampled for every composite.
Interior treatments With containment (Plastic sheeting as airlock on doors between treated and untreated areas)
Same as Category 1 but only in every treated room (up to four rooms)
AND One floor sample outside the containment area but within 10 feet of the airlock to determine the effectiveness of the containment system. This extra single-surface sample is recommended in 20 percent of the treated dwellings in multifamily housing and all single-family homes. For common areas, one floor sample for every 2,000 ft and one floor sample outside containment.
Same as Category 1 but only in every treated room AND One floor sample outside the containment area but within 10 feet of the airlock to determine the effectiveness of the containment system. This extra single-surface sample is recommended in 20 percent of the treated dwellings in multifamily housing and all single-family homes. For common areas, one floor subsample for every 2,000 ft (up to 8,000 ft for each composite) and one floor sample outside containment.
Exterior treatments Two dust samples as follows: At least one dust sample on a horizontal surface in part of the outdoor living area (e.g., a porch floor or entryway). One window trough sample on each floor where exterior work was performed. An additional trough sample should be collected from a few lower floors to determine if troughs below the area were contaminated by the work above.
Two dust samples as follows: One composite on a horizontal surface in part of the outdoor living area (e.g., a porch floor or entryway). One window trough composite for every four floors where exterior work was performed, including lower floors where exterior work was not done, if present.
Routine maintenance work At least 1 floor dust sample for every 20 high-hazard jobs near the work area.
Same as single-surface sampling.
Soil treatment One dust sample from the entryway.
One dust sample from the entryway.
64CSR45
64CSR45 .A room includes a hallway or a stairway. If no window, just one floor sample must be collected. When a closet is treated, the room to which it is attached should be tested. A closet is not considered to be a separate room. If all rooms received similar treatments and cleaning, only four rooms need to be sampled for clearance purposes. More rooms may need to be sampled in larger dwellings. The room to be sampled should be selected based on where most of the dust-generating work was done or in the judgment of the clearance examiner.
Series 46 Water Well Design Standards
W. Va. Code R. § 64-46-1 General
1.1. Scope. -- This legislative rule establishes the design standards for the installation of water wells, pumps and pumping equipment to protect public health and groundwater aquifers from contamination and pollution.
1.2. Authority. -- W. Va. Code §§16-1-4, 16-1-6(n), 16-1-9 and 16-1-9a.
1.3. Filing Date. -- April 2, 2008.
1.4. Effective Date. -- April 2, 2008.
1.5. Repeal of Former Rule -- This rule repeals and replaces West Virginia Department of Health’s Interpretive Rule, Water Well Design Standards, 64CSR46, 1984.
W. Va. Code R. § 64-46-2 Application
2.1. This rule applies to all water wells, pumps and pumping equipment installations other than those used to supply public water systems. Water wells for public water systems shall be installed, altered, and deepened in accordance with the Department’s rule, Public Water System Design Standards, 64CSR 77.
W. Va. Code R. § 64-46-3 Definitions
3.1. Abandoned water well. -- A water well that is no longer in use or is declared to be abandoned by the owner. A water well is also abandoned if the Commissioner has determined that the well presents a threat to groundwater or public health.
3.2. Abandonment of a water well. -- The act of properly sealing a water well in accordance with applicable standards.
3.3.ANSI. -- American National Standards Institute. ANSI creates standards for many water well applications, especially materials and equipment.
3.4. Annular Space. -- The space between a borehole wall and a permanent casing or between a temporary casing and a permanent casing or both.
3.5. API. -- American Petroleum Institute. API has specifications for steel casing.
3.6. Aquifer. -- A geological formation, group of formations, or part of a formation that yields ground water to a well.
3.7. ASHRAE. -- American Society of Heating, Refrigeration and Air – Conditioning Engineers. ASHRAE applications mainly relate to geothermal systems.
3.8. ASTM. -- American Society for Testing Materials. ASTM develops standards nationally and internationally for a wide array of materials and processes.
3.9. AWWA. -- American Water Works Association. AWWA is a non-profit scientific and educational society dedicated to the improvement of drinking water quality and supply.
3.10. Barnyard. -- A fenced area for animals, which generally adjoins the barn on a farm. It applies to traffic alleys, holding pens, convalescent pens, maternity pens, calf pens and confined exercise yards.
3.11. Bedrock. -- Solid rock exposed at the surface or overlain by unconsolidated materials.
3.12. Bentonite. -- A plastic, colloidal clay derived from volcanic ash consisting of at least 85% montmorillonite, with an ability to absorb fresh water and swell in volume.
3.12.a. Bentonite granules. -- Commercially manufactured pure bentonite, without additives, with a diameter of 3/8 inch or less.
3.12.b. Bentonite pellets. -- Commercially manufactured tablets made by compressing pure bentonite, without additives, into forms with a diameter ranging from 1/4 to 1/2 of an inch.
3.12.c. Bentonite chips. -- Commercially processed angular fragments of pure bentonite, without additives. Size ranges from 3/8 to 3/4 of an inch.
3.13. Bureau. -- The Bureau for Public Health of the West Virginia Department of Health and Human Resources.
3.14. Casing. -- The pipe or tubing, constructed of specific materials with specified dimensions and weights, that is installed in a borehole during or after completion of the borehole to support the side of the hole and thereby prevent caving, to allow completion of the water well, to prevent formation material from entering the water well, and to prevent entry of undesirable water into the well.
3.15. Closed-Loop Heat Pump Well. -- A well in which fluid is circulated in a continuous unbroken pipe beneath the surface of the earth or in a medium where the system can obtain a sufficient cooling or heat exchange. Depths of installation vary and are dependent upon the type and size of the closed-loop system, the land area available, soils/formation, climate, and seasonal variation in ground temperature, etc.
3.16. Commissioner. -- The Commissioner of the West Virginia Bureau for Public Health or his or her designee.
3.17. Commercial Well. -- A well that serves small businesses and facilities in which water is the prime ingredient of the service rendered.
3.18. Confined Water Table. -- Groundwater confined by an impervious layer of rock or other material under sufficient pressure to raise the water level above the upper level of the saturated zone when penetrated by a well.
3.19. Confined Aquifer. -- An aquifer bounded above and below by beds of distinctly lower permeability than that of the aquifer itself containing groundwater under pressure greater than that of the atmosphere. The term is synonymous with the term “artesian aquifer”.
3.20. Contaminant. -- Any substances either manmade or natural, which are concentrated enough to degrade water quality to a degree making the water harmful to public health or to the environment.
3.21. Contamination. -- Any manmade, man-induced or natural alteration of the chemical, physical, or biological integrity of the ground water, resulting from activities regulated under the West Virginia Department of Environmental Protection’s rule, Groundwater Protection Regulations, 47CSR58. Any alteration in excess of existing ground water quality, unless that site has been granted a deviation or variance from existing quality as provided in the West Virginia Ground Water Protection Act, or is subject to an order, permit, or other regulatory action that requires restoration or maintenance of ground water quality at a different concentration or level.
3.22. Dewatering Well. -- A well used to lower groundwater levels to allow for construction of footings, sewer lines, building foundations, dams, etc.
3.23. Direct Exchange Well (DX) -- A small diameter bore hole constructed for the purpose of sinking or sourcing thermal energy between the direct exchange loop and the earth. The refrigerant circulates throughout the heat exchange loop.
3.24. Disinfection. -- The inactivation of pathogenic organisms in water by chemical oxidants or equivalent agents, ultraviolet light, ozonation, or other methods approved by the Commissioner.
3.25. Drive Shoe. -- A device fastened to the bottom of a length of casing to protect the casing during driving.
3.26. Feedlot. -- A lot or facility (other than an aquatic animal production facility) where the following conditions are met: 1. animals (other than aquatic animals) have been, are or will be stabled or confined and fed or maintained for a total of forty-five days or more in any twelve month period, and 2. crops, vegetation forage growth, or post-harvest residues are not sustained in the normal growing season over other portions of the lot or facility. Two or more animal feeding operations under common ownership shall be considered, for the purposes of this rule, to be a single feedlot if they adjoin each other or if they use a common area or system for the disposal of wastes.
3.27. Filter Pack. -- Sand, gravel, or both placed in direct contact with the well screen.
3.28. Grout or Grout Material. -- A stable and impervious bonding material, with minimum shrinkage, capable of producing a watertight seal to protect against contamination, approved by the Commissioner.
3.29. Grouting. -- The placement of grout into the annular space to seal the annular space, and prevent the infiltration or migration of surface water and contaminants into the ground water aquifer.
3.30. Hand Dug Well. -- A manually excavated well of permanent nature installed for water supply.
3.31. Heat Pump or Geothermal Well. -- Any well constructed to use the heat exchange properties of either groundwater or of geologic material penetrated by the well.
3.32. IGSHPA. -- International Ground Source Heat Pump Association. IGSHPA is a non-profit organization, established in 1987 to advance ground source heat pump technology and applications.
3.33. Inactive Well. -- A well that is no longer actively used. It shall have a sanitary well cap and remain in a state of repair to prevent contamination from entering the well. It may be used in the future or be properly abandoned.
3.34. Industrial Well. -- A well used in industrial processing, fire protection, washing, packing, or manufacturing of a product excluding food and beverages, or similar non-potable uses.
3.35. Installation. -- The installation, alteration or deepening of a water well, pump and pump equipment.
3.36. Irrigation Well. -- A well used to provide water for plants, livestock, or other agricultural processes.
3.37. Location. -- The designation of the well site by using longitude and latitude or other approved means.
3.38. NSF. -- The National Sanitation Foundation. The NSF assists in educational and research programs, and develops standards pertinent to the areas of environmental sanitation and health.
3.39. NSF Potable Water (PW). -- Product standards for pressure-rated potable water applications as required by ANSI/NSF Standard 14 and ANSI/NSF Standard 61 for health effects.
3.40. Neat Cement. -- A mixture of Portland cement (ASTM C-150) and water in the proportion of 5 to 6 gallons of clean potable water per bag (94 pounds or 1 cubic foot) of cement.
3.41. Open-Loop Heat Pump Supply Water Well. -- A well drilled to supply water for heat transfer. Water quality, quantity and disposal are primary concerns with open- loop systems.
3.42. Permanent Casing. -- A durable, impervious pipe placed or driven into the borehole and left in place to maintain the well opening.
3.43. Pitless Adapter. -- A device approved by the Commissioner for attachment to one (1) or more openings through a well casing and constructed to prevent the entry of contamination into the well. The adapter is used to transfer water from the well, decrease the probability of frozen water lines and provide access to the well and water system components within the well.
3.44. Pitless Well Cap. -- A sanitary device, approved by the Commissioner, that covers and encloses the upper termination of a pitless well unit or the well casing to prevent entry of contamination into the well.
3.45. Pitless Unit. -- A preassembled device approved by the Commissioner which extends from the upper end of a well casing to above grade, provided with an approved well cap, and constructed to prevent the entry of contamination into the well. The unit is used to conduct water from the well, prevent the water from freezing and provide access to the well and water system components within the well.
3.46. Potable Water. -- Water free from impurities in amounts sufficient to cause disease or harmful physiological effects, with bacteriological, chemical, physical and radiological quality conforming to applicable rules and standards of the Bureau for Public Health.
3.47. Potable Water Well. -- Any water well that provides potable water, other than a public water supply for human consumption.
3.48. PPI. -- Plastics Pipe Institute. Founded in 1950, The Plastics Pipe Institute Inc. (PPI) is the major trade association representing all segments of the plastics piping industry.
3.49. Pressure Tank. -- A closed water and air storage device that modulates the water supply system pressure and sometimes allows for expansion during temperature fluctuations in the water system.
3.50. Public Water System. -- A public water system is any water supply or system that regularly supplies or offers to supply water for human consumption through pipes or other constructed conveyances, if serving at least an average of twenty-five individuals per day for at least sixty days per year, or which has at least fifteen service connections, and shall include:
3.50.1 Any collection, treatment, storage, and distribution facilities under the control of the owner or operator of the system and used primarily in connection with the system; and
3.50.2 Any collection or pretreatment storage facilities not under such control which are used primarily in connection with the system.
3.50.3. A public water system does not include a system that meets all of the following conditions:
3.50.3.a. It consists only of distribution and storage facilities, and does not have any collection or treatment facilities;
3.50.3.b. It obtains all of its water from, but is not owned or operated by, a public water system that otherwise meets the definition;
3.50.2.c. It does not sell water to any person; and
3.50.3.d. It is not a carrier conveying passengers in interstate commerce.
3.51. Pump. -- Any mechanical equipment or device used to transfer water from a well.
3.52. Pumping Equipment. -- Equipment or related materials that are used or intended to assist withdrawing groundwater from a well, including seals and other safeguards to protect the water from contamination; associated fittings; intake and discharge piping; and controls to provide sanitary water storage facilities and deliver water to a distribution piping system.
3.53. Rapid Joint Assembly. -- A device intended to join two pieces of pipe without threads or glue and approved by the ASTM or NSF.
3.54. Standard Dimension Ratio (SDR). -- The quotient obtained when the outside diameter of thermoplastic well casing is divided by the wall thickness.
3.55. Standing Column Open-Loop Well. -- A vertical well filled with water, in which water is removed from and returned to the same well for heat exchange.
3.56. Temporary Casing. -- A durable pipe placed or driven into a borehole to maintain an open annular space around the permanent casing during construction of a well.
3.57. Test Wells (Exploratory/ Observation). -- A well that is used to obtain information on groundwater quantity; quality; aquifer characteristics; and availability of production water supply for manufacturing, commercial, and industrial facilities.
3.58. Tremie Pipe. -- A small diameter pipe, hose, or tubing used in the down hole placement of well construction grouting material.
3.59. Unconsolidated Formation. -- A sediment that is loosely arranged whose particles are not cemented together, occurring either at the surface or at depth.
3.60. Under-reaming. -- A process of drilling just below casing to allow casing to be set while drilling, especially in unconsolidated or unstable formations.
3.61. Under-reamer. -- A drill bit used for under-reaming.
3.62. Unweathered Bedrock. -- Bedrock that is competent, firmly consolidated, and unaltered by erosion or surficial weathering.
3.63. Vertical Closed Loop Heat Pump Well. -- A borehole essentially perpendicular to the horizon into which a closed-loop pipe is placed for heat transfer.
3.64. Water system. -- Includes any well and equipment for distribution, extending from and including the source of the water to the point of discharge from any pressure tank or other storage vessel to the point of discharge from the water pump where no pressure tank or other storage vessel is present.
3.65. Watertight. -- A condition that does not allow the entrance, passage or flow of water under normal operating conditions.
3.66. Water Return Well. -- A well constructed for returning water that has passed through the heat pump system to the subsurface.
3.67. Water Well. -- Any excavation or penetration in the ground, whether drilled, bored, cored, driven, washed, jetted, hand dug or otherwise constructed that enters or passes through an aquifer for purposes that may include, but are not limited to, a potable water supply, exploration for water, industrial, irrigation, commercial, dewatering, or geothermal heat pump wells, and water return wells. This definition shall not include ground water monitoring activities, and all activities for the exploration, development, production, storage and recovery of coal, oil and gas and other mineral resources regulated under Chapters 22, 22a, or 22b of the WV Code.
3.68. Well Cap. -- A casing seal, approved by the Commissioner, that covers and encloses the upper termination of the well casing above the pitless well adapter or unit to prevent entry of contamination into the well.
3.69. Well Liner. -- A casing placed inside the well, which may be required due to conditions encountered during and after drilling. A liner does not include casing that, once installed, requires the placement of grout to comply with construction standards of this rule.
3.70. WSC. -- Water System Council. WSC is the only national, non-profit organization solely focused on household wells and small, water well systems.
W. Va. Code R. § 64-46-4 Location
4.1. A water well shall be located at least ten (10) feet from a property line to allow access without encroaching on property owned by others.
4.2. A water well shall be located as far as possible from any existing or potential sources of contamination in accordance with the following:
4.2.a. The required minimum horizontal distance between a water well, other than a well serving a public water system, and a source or potential source of pollution or contamination is shown in Table 64-46 A of this rule.
4.3. The top of the well casing shall not extend or terminate in the basement of any building or in a pit, room, or other space below ground surface.
4.4. All water wells shall be located to be accessible for cleaning, treatment, repair, testing, abandonment, and other maintenance.
4.5. A well located in an area subject to seasonal flooding or surface water contamination, shall be constructed in such a manner that seasonal floodwater cannot enter the well.
W. Va. Code R. § 64-46-5 Materials
5.1. Water well casing shall be sized to allow for installation of equipment for producing water that is adequate for the intended use and to allow for the installation and the maintenance of the well, pumps and related pumping equipment. In casing selection, certified well drillers should give consideration to forces imposed during installation and other forces that can be expected after installation and the corrosiveness of the water with which it comes in contact.
5.1.a. Steel casing shall be new, meeting AWWA Standard A-100, ASTM, or API specifications for water well construction, with a minimum wall thickness of 0.188 inches if the nominal pipe size is up to ten (10) inches and have a minimum wall thickness of .375 inches if the nominal pipe size is greater than ten (10) through twenty (20) inches:
5.1.a.1. Steel casing shall be joined by welds, threads, threaded couplings, or any combination thereof; and
5.1.a.2. When steel casing is driven, a standard drive shoe shall be welded or threaded on the lower end of the casing. The drive shoe shall have a beveled and tempered cutting edge of metal forged, cast or fabricated for this purpose.
5.1.b. Well liners and temporary steel casing used for construction shall be capable of withstanding the structural load imposed during their installation and removal. Well liners and temporary steel casing shall be approved by the ANSI/NSF, AWWA, ASTM, or their equivalent for potable water use.
5.1.c. Plastic well casings, liners, rapid joint assembly couplings, and solvents shall be approved by the ANSI/NSF Standard 14 and 61 and meet ASTM Standard F480.
5.1.c.1. Temporary casing shall meet ANSI/NSF Standard 61.
5.1.c.2. Plastic well casing shall not be driven during installation.
5.1.c.3. Plastic well casing shall be installed in accordance with the manufacturer’s specifications and shall have an outside diameter and minimum wall thickness as specified in Table 64-46 B of this rule.
5.1.c.4. All plastic casing and liners shall have a wall thickness that shall be of adequate thickness to prevent collapse due to hydrostatic pressure or temperature effects.
5.1.c.5. Each section of casing and liner shall display the NSF seal.
5.2. Nonferrous casing material proposed as a well casing, shall be resistant to the corrosiveness of water and to the stresses to which it shall be subjected to during installation and grouting. Casing material shall comply with ANSI/NSF Standard 61, Water System Components - Health Effects.
5.3. Well screens shall be constructed of materials resistant to damage by the chemical action of groundwater or cleaning operations, have size of openings based on sieve analysis of formation or gravel pack materials; have sufficient length and diameter to provide adequate specific capacity; and low aperture entrance velocity.
5.3.a. Well screens other than those commercially manufactured shall be constructed by creating slots or openings in approved casing material.
5.3.b. Plastic well screens shall comply with the ANSI/NSF Standard 61 - Water System Components - Health Effects.
5.3.c. Well screens shall not interconnect aquifers or zones which have suspected or documented differences in water quality that could result in contamination of any aquifer or zone; or interconnect aquifers or zones with different static water levels that would result in depletion of water from any aquifer or zone, or significant loss of head in any aquifer or zone.
5.4. Filter packs shall be silica based sand or gravel. The sand or gravel used for filter packs shall be hard and durable and shall have an average specific gravity of not less than 2.50. The sand and gravel shall be visibly free of clay, dust, and micaceous and organic matter. Not more than 5% of the sand or gravel shall be soluble in a 10% hydrochloric acid solution. Uniformity coefficients for filter pack material shall range from 1 to 3. All filter pack material should be purchased from a supplier who has properly cleaned and bagged the material.
5.5. Grout shall be neat cement, bentonite with cement mixtures, or bentonite. Other materials require the written approval of the Commissioner. The neat cement, bentonite with cement mixtures, and bentonite shall be mixed according to the manufacturer’s specifications. No drilling muds shall be used for grouting. Cement grouts shall be allowed to cure according to the manufacturer’s specifications before well drilling, construction, or testing may be resumed.
5.6. Water used during the initial construction of a water well shall be obtained from a public water system, water well or protected spring box. If additional water is required to complete the construction of the well, the driller shall use water from the best available potable source near the drill site. In the event that water from a public water system, water well or protected spring box is not available, the driller may obtain water directly from a surface supply other than a farm pond, open ditch or waste lagoon.
5.6.a. All water from a public water system, well or spring box shall also be treated with enough liquid bleach or hypochlorite granules to retain a free chlorine residual of at least two parts per million (2 ppm).
5.6.b. All water from a surface source shall be dosed with a fifty parts per million (50 ppm) of chlorine, i.e., two (2) gallons of sodium hypochlorite (laundry bleach, approximately five percent (5%) available chlorine) per one thousand (1,000) gallons of drilling water.
5.6.c. Surface water sources shall be free of mud, algae and other visible contaminants.
5.7. Packers, shall be made of material that shall not impart taste, odor, toxic substance, or bacterial contamination to the well water. They are usually made of rubber or neoprene collar (boot). Lead packers shall not be used.
5.8. Any additive used in the drilling, development, or grouting of a water supply designed for that purpose shall meet ANSI/NSF Standard 61.
W. Va. Code R. § 64-46-6 Construction; general
6.1. The minimum protected depths of drilled wells shall provide watertight construction to the depth required by the Commissioner to: exclude contamination; seal off formations that are, or may be, contaminated or yield undesirable water; and provide a minimum casing length as follows:
6.1.a. Nineteen (19) feet of casing in unconsolidated water bearing formations below ground level plus at least one (1) foot above finished grade, resulting in a total of twenty (20) feet;
6.1.b. Nineteen (19) feet of casing in bedrock wells with a minimum of five (5) feet of casing installed into unweathered bedrock below ground level, plus at least one (1) foot above finished grade resulting in a total of twenty (20) feet; or
6.1.c. The Commissioner may require other minimum casing depths in special circumstances.
6.2. The minimum borehole diameter, at the top of the water well, shall be four (4) inches.
6.3. The full length of the well casing shall be fully grouted from the lower terminus up to the ground surface, except as noted in subdivisions 6.3.a through 6.3.c of this section.
6.3.a. When drilling through caves, mines, or other cavities, the lower portion of the casing shall be grouted in accordance with the method described in subdivision 6.4.d of this section and a packer or similar bridging device shall be used to permit grouting above the cavity.
6.3.b. In unconsolidated aquifers (i.e., sand and gravel) above bedrock, the permanent casing shall be grouted.
6.3.c. In cases where a pitless adaptor is to be installed, upward grouting may terminate at the pitless adaptor level to allow for the installation of a pitless adapter.
6.4. All water wells shall have an annular space seal between the casing and borehole that forms a seal to prevent the entrance of water from sources other than the aquifers selected. The borehole diameter shall be sufficient to allow placement of the material to fully enclose and entirely seal the pipe.
6.4.a. When grouting below the water level, grout material shall be installed by a positive placement method, such as pumping or forced injection by air or hydraulic pressure, placed from the bottom up. The annular space shall be a minimum of 1.5 inches completely around the casing for grout. Grout shall be injected in the annular space between the inner casing and either the outer casing or the borehole. In wells where the outer casing shall be left in place, a dry bentonite is used while driving the casing.
6.4.b. When grouting above the water level, grout material installed by a positive placement method, such as pumping or forced injection by air or hydraulic pressure, placed from the bottom up, is the preferred method for grouting. The annular space shall be a minimum of 1.5 inches completely around the casing. A gravity emplacement method may be used for grouting above the water level, not exceeding thirty (30) feet in depth.
6.4.c. When under-reaming is used to set permanent casing in unconsolidated materials, either a dry or wet bentonite grout shall be used at the ground surface while the casing is being installed. Upon termination of casing in unweathered bedrock and removal of the under-reamer, bentonite or neat cement shall be placed in the bottom of the casing by a positive displacement or gravity placement method before casing is set in bedrock.
6.4.d. If rapid loss of grout material occurs during emplacement, coarse fill material (e.g., sand, gravel, crushed stone or dry cement) may be used in the zones in which the loss is occurring. The remainder of the annular space shall be grouted as provided in this section.
6.4.e. When driving casing with a cable tool rig through unconsolidated alluvial formations, a cone shaped depression or temporary outer casing filled with bentonite grout shall be maintained around the outside of the casing. The bottom of the driven casing shall be equipped with a drive shoe.
6.4.f. If the annular space cannot be grouted in accordance with this section, alternative methods shall obtain the written approval of the Commissioner.
6.4.g. The annular space shall be grouted as soon as possible, but not later than seven (7) calendar days after the well drilling has been completed and the drill rig is removed from the drill site location of a well.
6.5. Every well shall be developed to remove the native silts and clays, drilling mud, or finer fraction of the gravel pack resulting from drilling operations.
6.6. During the progress of work, water wells shall be provided protection to prevent tampering with the well or entrance of foreign materials. Once well drilling is complete and prior to departure of the drilling equipment from the well site, a WSC approved vector proof cap shall be securely installed. The well cap shall provide for ventilation. Vents shall be part of the well cap or may be attached to the well cap. They shall be turned down and screened to prevent entry of vermin. Toxic or flammable gasses shall be vented from a well to the outside above roof level or a point where they shall not produce a hazard. Wells installed in flood prone areas shall be watertight to prevent intrusion of floodwaters.
6.7. Permanent casing for all groundwater sources shall project a minimum of twelve (12) inches above the ground surface upon completion.
6.8. Pitless units designed to replace a section of well casing shall meet the standards of the WSC and shall be factory fabricated from point of connection with the well casing to the unit cap or cover. The materials used shall be durable and approved by the WSC. The pitless unit shall:
6.8.a. form an unbroken extension of the well casing from the point of discharge to a point above ground level as specified for upper well terminals; and
6.8.b. be installed by a threaded connection or welded to the cutoff casing. A compression flange gasket is not allowed. The threaded or welded connection to the cutoff casing shall be watertight.
6.9. Commercially manufactured pitless adapters shall be connected to the well casing with clamps, compression nuts, or by welding and shall form a watertight seal. To assure a watertight seal between the pitless adapter and the well casing, care shall be used in cutting the hole in the well casing with a hole-cutting saw or other Commissioner approved methods. All burs from the cutting process shall be removed. Both the outside and the inside surfaces of well casing surrounding the hole shall be smoothed. Pitless adapters shall be installed according to manufacturer’s specifications and shall meet the standards of WSC.
6.9.a. Pitless adapters shall be constructed and installed to prevent the entrance of contaminants into the well or water supply through openings in the well casing.
6.9.b. The pitless adapter shall provide adequate clearance within the well to allow insertion and withdrawal of the pump and system components through the upper terminal of the well casing.
6.10. Pump installation contractors shall not cut off or penetrate well casing below ground level except to install a pitless adapter or a pitless unit. A certified pump installer may join casing in accordance with this rule after obtaining the proper permit.
6.11. Well houses, if constructed, shall not be built directly over a water well.
W. Va. Code R. § 64-46-7 Pump Installation
7.1. At all times during the pump installation, the certified pump installer or well driller or both shall provide protection to prevent tampering with the well or entrance of foreign materials. The approved well cap shall be re-installed immediately upon completion of the pump installation and prior to departure of the certified pump installer or well driller.
7.2. The pumping capacity of the pump installed in a well shall be consistent with the intended use of the ground water and with the yield characteristics of the well.
7.3. Submersible pumps shall have a minimum of two (2) check valves installed. Install a properly sized (based on discharge pipe diameter) check valve for the pump, plus one (1) on the outer casing on top of the well unless it interferes with the function of the system.
7.4. Jet pumps shall have a check valve installed on the discharge side of the pressure tank and all clamps used shall be stainless steel.
7.5. Piping for turbine pump installation:
7.5.a. steel column pipe for line shaft turbine pump wells shall be standard weight flanged or threaded steel pipe, or
7.5.b. a plastic column pipe may be used for turbine pump installation provided the pipe is designed and manufactured for that purpose.
7.6. Torque arresters and cable guards shall be used as required by the manufacturer’s specification.
7.7. Electrical wiring and equipment used in connection with the installation of a water pump shall meet and be installed in accordance with any national, state, or local codes and ordinances.
7.7.a. All splices in electrical wiring shall be watertight.
7.7.b. Electrical wiring from the wellhead to the house shall be in a conduit or be an approved underground cable.
7.8. Pump controls for water wells shall be installed in accordance with manufacturer’s recommendations and shall include a pressure relief valve. All conduits, valves, piping, other plumbing fixtures and fittings should be NSF approved and suitable for potable water used to convey water from a water well to any building or other outlet.
7.9. Water service pipe from the well to the point of entrance to a building shall comply with all applicable standards and carry the seal of the NSF-Potable Water (PW).
7.9.a. The materials from which water supply system pipe fittings are made shall be compatible with the type of piping materials used in the water supply system.
7.9.b. All materials used for water piping shall be suitable for use with the maximum temperature, pressure, and velocity that may be encountered in the installation, including temporary increases and surges.
7.9.c. Water service piping shall be installed below the anticipated frost line, with a minimum depth of two (2) feet.
7.10. All components of a pumping system shall be in compliance with NSF standard 61.
7.11. Pressure tanks and switches shall be located above ground. A pressure tank and switch may be buried, provided the tank and switch are designed for installation below ground.
7.12. Water filters and water treatment units that are installed to accommodate water quality problems, as determined by physical, chemical, or bacteriological evaluation or field-testing shall achieve the results specified by the manufacturer. During installation or repair of the treatment units the sanitation of the water supply shall be protected.
W. Va. Code R. § 64-46-8 Disinfection
8.1. New potable water wells and existing potable water wells being placed into service or that have been disrupted for service or repair, such as new pump installation or reinstallation of an existing pump shall be disinfected.
8.1.a. The following standard disinfection procedure shall be used:
8.1.a.1. Materials which may be used for disinfection are; calcium hypochlorite, sodium hypochlorite, or other materials approved by the Commissioner; and
8.1.a.2. Disinfectant shall be placed in the well in quantities that produce a minimum concentration of at least 50 mg/l or parts per million (ppm). The amount required to obtain this concentration shall depend on the casing diameter and the amount of water standing in the well. The solution shall remain in the well for a period of at least 12 hours.
8.2. When working with disinfectants in ventilated places, the powder or strong liquid should not come in contact with skin or clothing. Solutions are best handled in wood, plastic or crockery containers because metals are corroded by strong disinfectant solutions.
W. Va. Code R. § 64-46-9 Repair of Water Wells
9.1. All materials used in the replacement, alteration or repair of any water well shall meet or exceed the requirements for a new installation.
9.2. Repairs or retrofits or both to wells, with the top of the well casing terminating below ground shall include extending the well casing above land surface with like material coupled in accordance with section 5 of this rule.
W. Va. Code R. § 64-46-10 Heat Pump Construction
10.1. Design Methods and Compliance.
10.1.a. The manufacturer’s design procedure shall follow a recognized methodology as presented in the most recent editions of IGSHPA and ASHRAE.
10.1.b. The ground heat exchanger design shall be clearly documented in order to determine compliance with the heat pump manufacturer’s or utility’s specifications or both.
10.2. Location of Heat Pump Wells Criteria.
10.2.a. Heat pump closed-loop wells shall be located at least twenty-five (25) feet from sewage absorption systems and known sources of contamination.
10.2.b. A closed-loop shall be located twenty-five (25) feet from all water wells. An open-loop shall be one hundred (100) feet from all water wells.
10.3. Casing Material.
10.3.a. If permanent casing is needed in a heat pump well, it shall be new steel casing.
10.4. Heat Pump Loop Material.
10.4.a. All pipe and heat-fused materials shall be manufactured from a virgin polyethylene extrusion compound material in accordance with ASTM Standard D-2513, and located in accordance with subsections 4.1 and 4.2 of this rule. The pipe shall be manufactured to outside diameters and wall thickness as specified in ASTM Standard D-3035 or D-2447. Fittings shall be manufactured to diameters, wall thicknesses, and respective tolerances as specified in ASTM Standard D-2683 for socket fittings and ASTM Standard F-1055 for electrofusion fittings.
10.4.a.1. The material shall maintain a 1600 psi (110.316 bar) Hydrostatic Design Basis at 73.4ºF (23.5ºC) per ASTM Standard D-2837, and be listed in PPI TR4 as a PE3408 piping formulation. The material shall be a high density extrusion compound having a cell classification of PE345434, PE355434, or PE3455534 with a UV stabilizer of C, D, or E as specified in ASTM Standard D-3350 with the following exception: this material shall exhibit zero failures (F0) when tested for a minimum of 192 hours under ASTM Standard D-1693, condition C, as required in ASTM Standard D-3350.
10.4.a.2. Dimensions.
10.4.a.2.A. Pipe with a diameter of less than 1¼” (3.175cm) (nominal) shall be manufactured in accordance with ASTM D-3035 with a minimum (based on pressure rating) dimension ratio of 11.
10.4.a.2.B. Pipe manufactured with a diameter from 1¼”(3.175cm) (nominal) up to three (3) inches in diameter, shall be manufactured in accordance with ASTM D-3035 with a minimum (based on pressure rating) dimension ratio of 11.
10.4.a.2.C. Pipe 3” (7.62cm) (nominal) and larger shall be manufactured in accordance with ASTM D-3035, (with a minimum [based on pressure rating] dimension ratio of 17) or D-2447 (Schedule 40). Table 64-46 C of this rule indicates the Water Pressure Ratings at 73.4ºF (23.5ºC) for DR-PR PE 3408 Plastic Pipe.
10.4.a.3. Markings, defined by the appropriate ASTM pipe standard shall be permanently marked on the length of the pipe as required information.
10.4.a.4. The manufacturer shall supply a notarized document confirming compliance with these standards, called a Certification of Materials.
10.4.b. All pipe joints and fittings installed and buried shall be socket or butt thermally fused according to the pipe manufacturer’s specifications. Glued or clamped joints shall not be used below ground. Joints shall not leak after assembly. Pressure testing of the closed-loop heat pump system network shall be conducted prior to putting the system into operation.
10.4.b.1. Acceptable methods for joining buried pipe systems are:
10.4.b.1.A. a heat fusion process;
10.4.b.1.B. stab-type fittings, quality controlled to provide a leak-free union between pipe ends that are stronger than the pipe itself or;
10.4.b.1.C. polyethylene pipe heat fused by butt, socket, sidewall, or electrofusion in accordance with the pipe manufacturer’s procedures. The individual performing fusion shall possess a fusion technician certification from IGSHPA or the pipe manufacturer. The instructor shall be IGSHPA approved to conduct pipe fusion classes.
10.4.b.1.D. Fusion transition fittings shall have threads used to adapt to copper, or fusion transition fittings shall have threads or barbs used to adapt to high strength hose. Barbed fittings shall not be permitted to be connected directly to polyethylene pipe, with the exception of stab-type fittings as described in subparagraph 10.4.b.1.B of this section. All mechanical connections shall be accessible.
10.5. Heat transfer liquids shall be IGSHPA approved fluids.
10.6. The diameter of a heat pump well shall be sufficient to allow placement of grout. The minimum diameter shall be four (4) inches.
10.7. Heat Pump Vertical Closed-Loop Wells.
10.7.a. Approved Grout Materials.
10.7.a.1. Approved sealing and filling materials shall include high solids bentonite grout—20-30% solids by weight, bentonite pellets or chips, or approved high efficiency, thermally enhanced grouts designed for heat transfer in geothermal applications. All shall meet manufacturer’s specifications.
10.7.a.2. All materials placed in the borehole shall be uncontaminated. All sand and gravel placed in the borehole shall be silica based and inert, unless a material other than silica is used in an IGSHPA approved, commercially available product that meets all other requirements.
10.7.a.3. Drill cuttings shall not be placed in the borehole as fill material.
10.7.b. Grouting.
10.7.b.1. Grout the entire length of the borehole from bottom to top with bentonite or thermally enhanced grout specifically designed to facilitate heat transfer and provide low permeability.
10.7.b.2. Boreholes with temporary casing may be grouted during or before removal of casing depending on borehole stability.
10.7.b.3. Grouting shall be completed immediately after installing the geothermal loop when reasonable to do so.
10.7.b.4. Boreholes with permanent casing shall be grouted before the top of the casing is terminated below ground level.
10.7.b.5. Boreholes with no casing shall be looped and grouted immediately after drilling.
10.7.b.6. Boreholes drilled with a mud system in unconsolidated formations shall be looped and grouted immediately after drilling.
10.7.b.7. Slurry mixtures shall be installed by pumping through a tremie pipe using a positive placement technique.
10.7.b.8. When voids are encountered (i.e. mined coal seams or caves), the borehole shall be cased from below the void to the surface.
10.7.c. Flushing, Purging, Pressure, and Flow Testing.
10.7.c.1. Loops shall be pressure tested before installation.
10.7.c.2. Loops shall be pressure tested after installation and grouting.
10.7.c.3. All horizontal components of the ground heat exchanger shall be flushed, pressure tested, and flow tested prior to backfilling.
10.7.c.4. Heat exchangers shall be tested hydrostatically at 150% of the pipe design rating or 300% of the system operating pressure if this value is the smaller of the two.
10.7.c.5. No visible leaks shall occur within a thirty (30) minute period.
10.7.c.6. Soil thermal conductivity testing overseen by an IGSHPA certified designer or comparable certification, shall be required for all systems with 50 or more tons capacity. The thermal conductivity test shall be conducted for a minimum of 48 hours.
10.8. Heat Pump Open-Loop Requirements.
10.8.a. Open loop wells shall be constructed in the same manner and conform to the water well construction standards set forth in this rule. This applies to return wells, standing column wells and supply wells. DEP generally requires permits for injecting or returning water to the subsurface and for surface discharges. It is the homeowner’s responsibility to obtain any required permits.
10.8.b. Pump tests shall be required for all open loop wells. The pump test shall demonstrate the well’s ability to produce 150 percent of the anticipated demand by sustaining this level of volume for twenty-four (24) continuous hours of stabilized flow; recovering to pre-pump test levels within twelve hours.
10.9. Direct Exchange Wells.
10.9.a. Direct exchange wells shall be constructed in the same manner and conform to the construction standards set out in this rule.
10.9.b. The direct exchange loop shall be constructed of copper tubing or other material approved by the Commissioner. All joints in the direct exchange loop shall be soldered and not brazed. The solder used shall withstand stresses associated with the direct exchange process.
10.9.c. The thermal fluid or refrigerant used in the direct exchange well tubing shall be biodegradable and non-toxic.
10.9.d. All loops shall be at least ten (10) feet from underground utilities due to the potential for freezing as heat is removed from the ground for heating.
W. Va. Code R. § 64-46-11 Dewatering and Dug Wells Construction
11.1. Dewatering wells generally withdraw shallow ground water for construction purposes; grouting of the annular space may be minimized. Each dewatering well is unique. Submit plans to the Commissioner for approval. Dewatering wells shall be immediately sealed using methods described in section 12 of this rule after dewatering has ceased.
11.2. Every hand dug well shall have a continuous watertight lining of steel casing, concrete pipe, or other approved casing material, extending from above ground surface to a depth of at least ten (10) feet below the ground surface. When more than one formation bearing suitable water exists, the lower formation should be used. The lining in the producing zone shall readily admit water and shall be structurally sound to withstand external pressures. Each hand dug well is unique. Develop and submit plans to the Commissioner for approval.
11.2.a. The open space between the excavation and the installed lining shall be sealed with grout. If the first ten (10) feet of the casing is jointed, such as concrete, and would allow surface water to seep into cracks of casing, the grout shall continue from the ten (10) foot seal to ground level.
W. Va. Code R. § 64-46-12 Water Well Abandonment
12.1. When a water well is abandoned, the work shall be performed by a West Virginia Certified Water Well Driller.
12.2. All wells shall be completely filled with grout to prevent contamination from entering the subsurface water bearing formations and ground water mixing with one aquifer to another. Bentonite or cement grout shall be used for grouting material. If the well is so large that, the use of these materials is not practical, the Commissioner shall determine a proper plugging process. Methods and materials shall be selected only after careful consideration of casing material, casing condition, the diameter of the casing, the quality and quantity of the original grout seal, the depth of the well, well plumbness, the hydrogeologic setting, the level of contamination, and the zones where contamination occurs. All abandonment of a water well procedures shall prevent groundwater contamination.
12.3. Screens, casings, and liner pipes shall be pulled whenever possible to assure placement of an effective seal. The borehole shall be completely sealed in such a manner that the vertical movement of water within the annular space is effectively and permanently prevented. When the casing is removed and the borehole is unstable, grout shall be simultaneously emplaced as the casing is removed to prevent collapse of the borehole; however, if the casing is left in place, the borehole shall be completely grouted from the bottom to the top with approved grouting material to reduce the possibility of annular channeling.
12.4. All pumps, wiring, pipes, valves, accessories, and hardware that may interfere with abandonment of a water well operations shall be removed prior to abandonment of a water well.
12.5. Water wells in consolidated formations shall be completely filled with grout to prevent contaminating materials from entering the subsurface water bearing formations and ground water from one aquifer mixing with that of another aquifer.
12.6. Water wells in unconsolidated formations shall be sealed with bentonite, cement, or a bentonite-cement mixture from bottom to top.
12.7. For abandoned water wells that penetrate limestone or other creviced or channelized rock formations that show a loss of grout while filling; stone, pea gravel, or other approved bridging agents may be used to seal these zones.
12.8. Hand dug or bucket drilled water wells exceeding twenty-four (24) inches in diameter shall be abandoned by the same method and with the same grouting materials as used in unconsolidated formations.
12.9. Flowing artesian wells shall be abandoned with grout from the bottom of the well to the ground surface, using a tremie pipe and pump. The added slurry weight of the cement-based or bentonite materials shall be necessary to overcome the naturally occurring pressuring characteristic of artesian flowing wells. For a large artesian flowing well (pressure head), it may be necessary to control the head or flow while placing the sealing material with the use of an inflatable packer to stop or restrict the flow of water.
12.10. Boreholes drilled for any geothermal uses or for a potential system that are unused in the final system shall be abandoned in accordance with this section.
W. Va. Code R. § 64-46-13 Additional Requirements
13.1. All installations and operations shall meet or exceed relevant requirements of national, state, or local codes, whichever government body has jurisdiction.
13.2. The Commissioner shall specify construction requirements more stringent than those specified in this rule within specific areas of concern to protect the public health or prevent contamination of groundwater. The specific areas of concern recommendations shall be based on the assessment of the hydrologic condition and contaminant characteristics that may require more stringent design standards. Prior to requiring more stringent standards within a specific area of concern the Commissioner shall submit a report to the advisory board, established under the Bureau’s rule, Water Well Regulation, 64CSR19, section 11, for its review and recommendations.
13.3. When the strict application of any provision of this rule presents practical difficulties or unusual hardship, the Commissioner may grant a variance for that specific instance. Variance requests shall be made in writing to the Commissioner on forms prescribed by the Commissioner. The request shall include a thorough description of the site (lot size, the location of sewers, septic tanks, buildings, seepage fields, and other sources of contamination on the property and adjacent property with distances shown to the proposed well) and a brief summary of the provisions for which a variance is requested, and a complete justification as to why the variance is needed. The requestor shall include how the alternate standard protects the quality of groundwater and protects public health and safety. The request shall provide a description of site-specific geologic and soil conditions. The Commissioner shall not grant any variance unless the applicant demonstrates that there will be unusual and unnecessary hardship in complying with the rules; contamination of the water well will not occur as a result of construction and operation of the system; the health of persons using water from the private water system will not be endangered thereby; and no other technically feasible and economically reasonable means of obtaining water from the proposed type of water source exists. The Commissioner shall notify the applicant in writing within thirty (30) calendar days of its decision to either grant or deny the variance. In all cases, variances shall be approved in advance of the performance of the actual work.
13.3.a. After any variance is issued regarding the location of a well with respect to various contamination sources in Table 46-46 A of this rule, the Commissioner shall take two (2) water samples from the well and have them analyzed for Total coliform and E. coli at an approved laboratory. The Commissioner may require analysis for other water quality parameters that may exist in conjunction with the source of potential pollution as necessary to protect the health or safety of potential users. At the time the variance is approved, the Commissioner shall notify the owner as to what these parameters are. One (1) sample shall be taken within thirty (30) days and the second sample shall be taken within sixty (60) days, after completion of the well. After receiving the water analysis, the Commissioner shall determine if a water treatment unit shall be installed to accommodate any water quality problems as determined by the chemical and bacteriological testing.
13.3.b. Examples of location problems which could preclude compliance with this rule include the proposed location of a well being too close to septic tanks, buildings, sewer lines, or barnyards as indicated in Table 64-46 A of this rule.
13.3.c. Examples of public health and engineering principles that may be considered in issuing a variance are ground surface conditions, the depth of the water table, the location of sources of pollutants, the vulnerability of the aquifer to bacteria and other pollutants, and the geologic conditions at the site.
TABLE 64-46 A
Minimum Horizontal Distance Between a Groundwater Well and Source Source Minimum Distance Septic Tanks 50 feet (100 feet)* Sewage Treatment Facilities 200 feet Sewers and Drains (Watertight) 10 feet Drains (Non-watertight) 50 feet (100 feet)
Sewage Holding Tanks and Privies (Vault) 50 feet (100 feet)
Barnyard/Feeding and Watering Areas 100 feet Streams, Rivers, and Impoundments 25 feet Sewage Absorption Fields 100 feet Existing Building or Foundation 10 feet Storage or Preparation Area for Fertilizers and Pesticides 150 feet Buried Oil, Gasoline, Chemical Storage Tanks 50 feet (100 feet)
Cemetery 50 feet (100 feet) *Note: The distance noted in parenthesis is required when a water well is lower in elevation than the source of pollution or contamination referenced.
TABLE 64-46 B
Diameter and Wall Thickness of Plastic Well Casing and Liners Nominal Size O.D.* Class Minimum Wall Thickness 2”
2.375 .154 3”
3.500 .216 4”
4.500 SDR 17 .173 .214 .265 4 ½ ”
4.950 SDR 40
SDR 17 .190 .248 .291 5”
5.563 SDR 17 .265 .327 6”
6.625 SDR 17 .255 .280 .316 .390 6 ¼”
6.900 SDR 27.6 .329 .250 8”
8.625 .332 .410 10”
10.750 .413 .511 12”
12.750 SDR26** .490 .606 14”
14.000 .437 .667 16”
16.000 SDR 26 .500 .616
Note: Dimensions are in inches. * O. D. = outer (or outside) diameter ** = Used for liner only Liner Pipe Only for the 2”, 3” and 4” nominal pipe size.
All dimensions and weights are subject to normal manufacturing tolerances.
TABLE 64-46 C
Geothermal Water Pressure Ratings at 73.4ºF (23.5ºC) for DR-PR PE 3408 Plastic Pipe for Closed Loop Ground Heat Exchangers Dimension Ration of Pipe Pressure Rating (psi)
9.3
13.5
15.5 64CSR46
64CSR46
Series 47 Sewage Treatment and Collection System Design Standards
W. Va. Code R. § 64-47-1 General
1.1. Scope. -- This legislative rule establishes the design standards for sewage treatment or collection system construction and operation.
1.2. Authority. -- W. Va. Code §16-1-4 and §16-1-9.
1.3. Filing Date. -- May 9, 2025.
1.4. Effective Date. -- July 1, 2025.
1.5 Sunset Date. -- This rule shall terminate and have no further force or effect on August 1, 2030.
1.6. Applicability. -- This rule applies to any person involved in the construction or operation of sewage treatment or collection systems requiring approval by the Bureau for Public Health.
1.7. Enforcement. -- This rule is enforced by the Commissioner of the Bureau for Public Health or his or her designee.
W. Va. Code R. § 64-47-2 Definitions
2.1. Acceptable Application. -- The completed forms, plans, specifications, fee, if required, and other data as specified by this rule or by instructions issued by the commissioner of the Bureau for Public Health.
2.2. Accessible. -- When the location of a public sewer system is adjacent to, or available by right-of-way to, a particular lot, and sewage can discharge by gravity.
2.3. Approved. -- A procedure of operation or construction that is in accordance with design standards, specifications and instructions established by the Department.
2.4. BOD. -- Biochemical oxygen demand.
2.5. Bureau. -- The Bureau for Public Health.
2.6. Chief. -- The chief of the Office of Water Resources of the department of environmental protection, or his or her designee.
2.7. Commissioner. -- The Commissioner of the Bureau for Public Health, or his or her designee.
2.8. Department. -- The West Virginia Department of Health and Human Resources.
2.9. Design Standards. -- Application procedures, design requirements, specifications and construction standards promulgated by the Bureau for Public Health.
2.10. Effluent. -- Liquid discharge from a sewage treatment or disposal system.
2.11. Establishment. -- A building, structure or place used or intended to be used for multiple dwelling units, or for manufacturing, commercial, religious, institutional, educational or recreational purposes.
2.12. Individual Sewer System. -- A system with a daily design flow not to exceed one thousand (1,000) gallons per day with subsurface discharge or not to exceed six hundred (600) gallons per day design flow with surface discharge. A single entity owns and performs maintenance of the system.
2.13. Municipal Sewer System. -- A system or group of systems that receives sewage from more than one (1) dwelling or establishment that is operated and maintained by an incorporated municipality, public service district, or sanitary board.
2.14. Percolation Test. -- A method described in this rule for evaluating soils in a particular area for subsurface effluent disposal.
2.15. Permit. -- A written document issued by the Commissioner that gives permission to construct, install, extend, alter or operate an approved sewer system, use a method of sewage disposal, or to collect, remove, transport or dispose of sewage.
2.16. Person. -- Individual, partnership, association, syndicate, company, firm, trust, corporation, government corporation, institution, department, division, bureau, agency, or any other entity recognized by law.
2.17. Public Sewer System. -- A sewage collection system or systems, including municipal sewer systems. with or without treatment facilities, with a daily design flow greater than 1,000 gallons per day with subsurface discharge or greater than 600 gallons per day with surface discharge, serving one or more dwellings or establishments. A single entity owns and performs maintenance on the system.
2.18. Sewage. -- Excreta or liquid waste containing animal or vegetable matter in suspension or solution including, but not limited to, waste from commodes, urinals, lavatories, bathtubs, laundry tubs, washing machines, drinking fountains, sinks, kitchen equipment, and other sanitary fixtures or facilities.
2.19. Sewer System. -- A publicly or privately owned system that receives and treats sewage and provides for the disposal of effluent and sludge that comes from it. This definition includes individual sewer systems and public sewer systems.
2.20. Sewage Tank. -- A watertight receptacle designed and constructed to receive and retain sewage solids. Sewage tanks include, but are not limited to, septic tanks, aeration type sewage treatment systems, privy vaults, holding tanks or receptacles and self-contained excreta disposal facilities.
2.21. Sewage Tank Cleaner. -- A person engaged in the collection, removal, transportation or disposal of sewage.
2.22. Standard Soil Absorption System -- A system designed to receive effluent from a septic tank and dispose of it at depths ranging from 18 to 36 inches from the original ground surface.
2.23. Subdivision. -- The result of the division of a tract of land into two or more lots, tracts, parcels, plats, sites, areas, units, interests, or other division for the purpose of dwelling or establishment development and including the division of land by deed, metes and bounds description, lease, map, plat or other instrument, or by act of construction.
2.24. Wastewater. -- Water containing human, animal or domestic waste.
2.25. Water Well. -- Any excavation or penetration in the ground, that enters or passes through an aquifer for purposes that may include, but are not limited to, a water supply, exploration for water, dewatering, or heat pump wells. This definition does not include ground water monitoring activities and all activities for the exploration, development, production, storage and recovery of coal, oil, and gas and other mineral resources regulated under W. Va. Code §22-1-1 et seq., §22A-1-1 et seq., or §22B-1-1 et seq.
W. Va. Code R. § 64-47-3 Sewage Permit Applications
3.1. Application for Permits.
3.1.a. An applicant shall submit a completed application for a permit in accordance with “Sewage System Rules,” 64CSR9, this rule and the instructions of the Commissioner.
3.1.b. Several application packages are available for the various methods of sewage collection, treatment, disposal and types of facilities served. To determine which application package to request, an applicant shall refer to Table 64-47-A. at the end of this rule.
3.1.c. An applicant may obtain an application package from the environmental engineering division, Office of Environmental Health Services, Bureau for Public Health.
3.1.d. An applicant shall determine minimum design loadings for various types of sewage treatment facilities by referring to Table 64-47-B. at the end of this rule.
3.2. Revisions to Approved Plans and Specifications. The Commissioner shall approve in writing any deviations from approved plans or specifications affecting capacity, flow or operation of units before the applicant makes any changes. The applicant shall submit revised plans or specifications to the Commissioner well in advance of any change he or she is planning in construction work to give the Commissioner sufficient time for review and approval. Structural revisions or other minor changes during construction that do not affect capacities, flows or operation may be made without approval by the Commissioner. At the Commissioner’s request, the applicant shall submit final drawings to the bureau and the municipality at the completion of the work, clearly showing the completed alteration.
3.3. Operation During Construction. The applicant shall provide specifications to the Commissioner that details a program for keeping existing treatment plant units in operation during construction of plant additions. The applicant shall submit to the bureau and the chief the shutdown schedule agreed to by the bureau and the chief, should it be necessary to take plant units out of operation.
W. Va. Code R. § 64-47-4 Sewage Collection Systems
4.1. General.
4.1.a. Design. The design of new systems or extensions to existing systems shall carry sanitary sewage flows plus contain an allowance for non-excessive infiltration.
4.1.b. Modifications. Modifications to the design on existing systems shall be to carry sanitary sewage flows plus contain an allowance for non-excessive infiltration and inflow.
4.1.c. Overflows. The Commissioner shall review on a case-by-case basis, overflows from new interceptor sewers.
4.1.d. Combined Sewers. The Commissioner shall not approve new combined systems.
4.1.e. Design Factors. In determining the required capacities of sanitary sewers, an applicant shall consider the following factors:
4.1.e.1. Maximum hourly quantity of sewage;
4.1.e.2. Additional maximum wastewater flow from industrial plants; and
4.1.e.3. Groundwater infiltration.
4.1.f. Design Basis Per Capita Flow. To arrive at average dry weather flows from combined residential, commercial, and institutional sources, an applicant shall design a new system on the basis of one of the following two methods:
4.1.f.1. Using estimates based on a one-year record of a fully documented analysis of water use adjusted for consumption and losses; or
4.1.f.2. Using state developed per capita wastewater flows using 70 GPCD or existing water usage records for various sizes and types of municipalities.
4.2. Gravity.
4.2.a. Design Period. The maximum allowable design period for sewers is 50 years for the estimated tributary area. This rule shall allow phasing of collection system.
4.2.b. Infiltration Allowance and Industrial Flows. The Commissioner may add an infiltration allowance to the per capita design flows of 200 gallons per inch diameter per mile per day and a reasonable allowance for future industries to arrive at the average daily flow (ADF).
4.2.c. Peak Flows.
4.2.c.1. When flowing full, an applicant shall make sewer designs to carry a peak flow of:
4.2.c.1.A. Lateral Sewers - 4 x ADF; and
4.2.c.1.B. Trunk and Interceptor and Outfall Sewers - 2.5 x ADF.
4.2.d. When deviating from the above stated peak design flows, an applicant shall provide in the design engineering report a brief justification and description of the procedure he or she used for sewer design.
4.2.e. Calculation. An applicant shall present computations and other design data for proposed sewage collection and treatment facilities of greater than 100,000 gallons per day, in an appropriate form to the Commissioner. The computations shall include:
4.2.e.1. Average daily flow and peak daily flow at critical points such as the change in size of sewers; and
4.2.e.2. The velocity at minimum, average and peak flows in sewers, as required.
4.2.f. Minimum Size.
4.2.f.1. No gravity sewer shall be less than eight inches in diameter except for using six inch diameter sewer pipe for lateral sewers when:
4.2.f.1.A. No possibility of future extension exists; and
4.2.f.2.B. The sewer cannot service more than either 30 mobile homes or 23 residences.
4.2.f.2. There shall be no allowance for a four-inch sewer pipe for the gravity collection system.
4.2.g. Small Diameter-Gravity Sewers.
4.2.g.1. On a case-by-case basis the Commissioner may allow these sewers for sanitary sewage collection.
4.2.g.2. Pretreatment is a requirement prior to discharge into these small diameter-gravity sewers.
4.2.g.3. The minimum pipe size is four inches.
4.2.g.4. An applicant may use cleanouts instead of manholes and shall install them:
4.2.g.4.A. At all changes in direction; and
4.2.g.4.B. At all connections.
4.2.h. Cover. The minimum allowable earth cover on sewers is three feet unless otherwise approved by the Commissioner. Generally, sewers shall be sufficiently deep enough to drain basement fixtures, to protect the sewers from surface loadings and to prevent freezing.
4.2.i. Slope.
4.2.i.1. For new sewers, the design and construction shall be to give velocities, when flowing full, of not less than two feet per second based on Kutter's or Manning's formula using an "n" value of 0.013.
4.2.i.2. For existing sewers, the Commissioner recommends a value of "n" as 0.015 to determine existing capacities. The Commissioner shall grant permission to use other practical "n" values if he or she considers it justifiable on the basis of research or field data an applicant presents.
4.2.i.3. The Commissioner recommends slopes greater than the ones in Table 64-47-C. at the end of this rule that contains minimum required slopes.
4.2.i.4. Under special conditions, if detailed data given are justifiable, the Commissioner may grant an applicant permission to use slopes slightly less than those required for the two feet per second velocity when flowing full. When selecting decreased slopes, the engineer shall provide the Commissioner a report and the computations of the depth of flow in the pipes at minimum, average, and peak rates of flow. This rule recognizes that the decreased slopes may cause additional sewer maintenance.
4.2.i.5. Sewers shall lay in a straight line with uniform slope between manholes. Concrete anchors, or approved equal, shall anchor sewers laid on a 20% slope or greater and spaced as follows:
4.2.i.5.A. Not over 36 feet center to center on slopes between 20% to 35%.
4.2.i.5.B. Not over 24 feet center to center on slopes between 35% to 50%.
4.2.i.5.C. Not over 16 feet center to center on slopes 50% and over.
4.2.j. Alignment. Sewers 24 inches in diameter or less shall lay with straight alignment between manholes.
4.2.k. Increasing Size. When a sewer joins a larger one, the invert of the larger sewer shall be sufficiently lower to maintain the same energy gradient. An approximate method for securing these results is to place the 0.8 depth of both sewers at the same elevation.
4.2.l. High Velocity Protection. An applicant shall make special provisions to protect against displacement by erosion and shock when velocities are greater than 15 feet per second.
4.2.m. Materials. The material selected for the pipe shall be adaptable to local conditions, such as character of industrial wastes, possibility of septicity, soil characteristics, exceptionally heavy external loadings, abrasion, and similar problems.
4.2.n. Types of Gravity Pipe. Design of all sewers shall be to prevent damage from superimposed loads. Proper allowance for loads on the sewer shall be according to the width and depth of trench. Construction of gravity sewer lines shall be of clay, plastic, ductile iron, or concrete sewer pipe meeting the following minimum specifications:
4.2.n.1. House Connection to Collector Sewers:
Clay - ASTM C 700 Plastic - ASTM D 2729, D 2751, D 2836, D 2852 Ductile Iron - AWWA C-110, C-151, Cement lined Concrete - ASTM C 14
4.2.n.2. Collector and Interceptor Sewers:
Clay - ASTM C 700 - Joints meet the requirements of ASTM C 425. This rule does not permit seal joints or cement joints.
Plastic - ASTM D 3033, D 3034, F 789, A 2000 Composite - ASTM D 2680 Ductile Iron - AWWA C-110, C-151, Cement lined Concrete - ASTM C-76
4.2.o. Bedding. In accordance with ASCE Manual & Report on Engineering Practice No. 37, bedding shall be Class “A”, “B”, “C.” To provide the strength necessary for future soil and load conditions, the engineer shall determine the class of bedding.
4.2.p. Inverted Siphons. Inverted siphons shall have not less than two barrels, with a minimum pipe size of six inches, and be provided with necessary appurtenances for convenient flushing and maintenance. The manholes shall have adequate clearances for rodding; and in general, provide sufficient head and pipe sizes selected to secure velocities of at least three feet per second for average flows. Arrangement of the inlet and outlet details shall be to divert the normal flow to one barrel in order to take either barrel out of service for cleaning. Use of ductile iron pipe or equal is a requirement.
4.2.q. Stream Crossing. When sewers must cross under a stream or watercourse, there shall be a minimum separation of three feet between the stream bed and the top of the sewer pipe. However, the Commissioner may approve other methods provided there is equivalent protection and performance. Use of ductile iron pipe or equal is a requirement.
4.2.r. Aerial Sewers. Aerial sewers require the Commissioner’s prior approval.
4.2.s. Protection of Drinking Water Supplies.
4.2.s.1. Water Supply Interconnections. There shall be no physical connection between a public or private drinking water supply system and a sewer or appurtenance.
4.2.s.2. Relation to Public Water Systems. A general guideline is that gravity or pressure sanitary sewers, or both, shall be at least 10 feet horizontally from a drinking water supply.
4.2.s.3. Relation to Wells. No gravity or pressure sanitary sewer line shall be located within 50 feet of a public, private, or individual homeowner's drinking water well. However, if physical limitations prevent a 50-foot separation, the Commissioner may give written approval for variance from these requirements. Under no conditions shall the construction of any gravity or pressure sanitary sewer be closer than 10 feet to a private homeowner's well.
4.2.s.4. Relation to Water Lines.
4.2.s.4.A. Horizontal Separation. Gravity or pressure sanitary sewers shall be at a minimum of 10 feet horizontally away from any existing or proposed water lines. However, if maintaining the 10-foot horizontal separation is not possible, the construction of the sewer and testing shall be as prescribed in paragraph 4.2.s.5. of this rule. A sewer shall not be constructed closer than three feet edge to edge to a water line.
4.2.s.4.B. Vertical Separation. When a gravity or pressure sanitary sewer must cross water lines, its construction shall be at an elevation so that the top of the sewer line is a minimum of 18 inches beneath the bottom of the water main. However, if meeting the 18-inch vertical separation requirement is not possible, then the construction of the sewer and testing shall be as prescribed in paragraph 4.2.s.5. of this rule.
4.2.s.5. Special Construction Requirements.
4.2.s.5.A. Horizontal. In cases where water and gravity or pressure sanitary sewer lines must lay closer than 10 feet apart, the sewer line construction shall be a minimum of 18 inches lower than the water line and constructed of a pressure type pipe meeting requirements for water lines. The installation shall undergo hydraulic testing for a period of not less than 24 hours and considered satisfactory if leakage is not more than 0.25 gallons per inch diameter of pipe per joint. In lieu of hydraulic testing, the sewer line can be air tested. The placement of the water line shall be upon an undisturbed earth shelf or bench. Backfilling to create the bench is not permissible. Maintaining maximum possible horizontal distance between the lines is a requirement. Where meeting these conditions is not possible, an applicant shall obtain written approval for a variance from the Commissioner. When placement of the lines is within five feet of each other, each line shall have a metallic impregnated, permanent identification tape buried directly above it denoting "sewer line" or "potable water line."
4.2.s.5.B. Vertical. If maintaining a vertical clearance of 18 inches as specified in subparagraph 4.2.s.4.B. of this rule is not possible, the location of the gravity or pressure sanitary sewer shall be so that it crosses between joints of the water line. Also, construction of the sewer line shall be so that it crosses under the water line at mid joint. The construction of the sewer shall be of a pressure type pipe meeting the requirements for water lines at the crossing. This rule requires maintaining a minimum vertical clearance of six inches between the sewer and water lines. The construction of a gravity or pressure sanitary sewer line, or both, shall not be over the top of a water line. However, when meeting the standard vertical installation requirements is not possible, encase the sewer line so that the casing extends at least 10 feet on each side of the crossing. This rule requires maintaining a minimum vertical separation of 18 inches between the lines.
4.2.t. Sewer Riser Pipes.
4.2.t.1. All mobile home lots shall have a sewer riser pipe with a minimum diameter of four inches and extend at least four inches above the ground in a vertical position.
4.2.t.2. When not serving a mobile home, all sewer riser pipes shall be tightly capped or plugged to keep them watertight.
4.3. Manholes.
4.3.a. Location. Manholes shall be placed:
4.3.a.1. At the end of each sewer line;
4.3.a.2. At all changes in slope, size, or alignment;
4.3.a.3. At all intersections; and
4.3.a.4. At distances not greater than 400 feet for sewers 15 inches in diameter or less, and 500 feet for sewers 18 inches to 30 inches in diameter. The Commissioner may waive this requirement and permit greater spacing in larger sewers and in sewers carrying settled effluent.
4.3.a.5. This rule allows for the construction of cleanouts at the upper end of all lines. In some special conditions, cleanouts may replace manholes, but installation of them requires approval by the Commissioner prior to installation.
4.3.b. Materials. Manholes shall be pre-cast concrete, poured-in-place concrete, or concrete manhole block.
4.3.c. Drop Type. A sewer entering a manhole at an elevation of 24 inches or more above the manhole invert provides for outside drop pipe. The entire drop connection shall be encased in concrete. If an inside drop is necessary, the manhole and access provided for cleaning shall have a pipe fastened to it.
4.3.d. Diameter. The minimum base diameter of manholes shall be 48 inches. Larger diameters are preferable for large diameter sewers with a minimum opening of 24 inches.
4.3.e. Steps. There shall be a provision for non-corrosive steps embedded in the walls, offset and spaced 12 to 18 inches apart vertically.
4.3.f. Flow Channel. The inside base of the manhole shall be filled with concrete to form a bench sloping toward the flow channel. In addition, both the flow channel and the bench shall be troweled to a smooth surface.
4.3.g. Watertightness. Solid manhole covers are required where the manhole covers may flood by street runoff or high water.
4.3.g.1. Manholes of segmented block shall have waterproofing on the exterior with plaster coatings, supplemented by a bituminous waterproof coating;
4.3.g.2. Concrete manholes shall have waterproofing on the exterior where groundwater conditions are unfavorable; and
4.3.g.3. Pipe connections to manholes and joints on manholes shall be watertight.
4.4. Pumping Station.
4.4.a. General.
4.4.a.1. Flooding. The location of stations including electrical equipment shall be at an elevation not subject to the 100-year flood or otherwise have adequate protection against the 100-year flood.
4.4.a.2. Location.
4.4.a.2.A. Preferably, the location shall be off the right-of-way of streets and alleys and shall be a suitable structure;
4.4.a.2.B. The station shall be readily accessible, but be as far as possible from the nearest dwelling; and
4.4.a.2.C. Fencing shall be required to prevent entry of unauthorized persons unless the Commissioner gives prior approval for an alternative method.
4.4.a.3. Overflows. There shall be no overflows or bypasses from lift stations at new facilities.
4.4.a.4. Pumping Rates and Number of Pumping Units. All lift stations, each capable of providing the maximum design flow, shall have minimum dual pumps. The size of the pumping units shall be to provide the minimum cleaning velocity of two feet per second at the rated capacity, assuming a C=120 for plastic pipe and C=100 for all other pipe materials in the Hazed-Williams Formula.
4.4.a.5. Type. The Commissioner may approve the wet well or wet well/dry well type, or both.
4.4.b. Design.
4.4.b.1. Long Drive Shaft Pumps. A wet well installation achieved by mounting the pump in the wet well and connecting it by a drive shaft to the motor above the wet well shall not be approved.
4.4.b.2. Separation. There shall be complete separation of the wet well and dry well, including its superstructure.
4.4.b.3. Pump Removal. There shall be provisions to facilitate removing pumps and motors.
4.4.b.4. Access. Dry wells of pumping stations and wet wells containing either bar screens or mechanical equipment requiring inspection or maintenance shall have suitable and safe means of access.
4.4.b.5. Size. The effective capacity of the wet well shall provide a detention time not exceeding 30 minutes for the design average flow.
4.4.b.6. Floor Slope. The wet well floor shall have a minimum slope of one to one towards the hopper bottom. The horizontal area of the hopper bottom shall be no greater than necessary for proper installation and function of the inlet. Bottoms shall have a smooth finish.
4.4.b.7. Protection Against Clogging.
4.4.b.7.A. Readily accessible bar screens with clear openings not exceeding 2.5 inches, unless using pneumatic ejectors or installing special devices to protect the pumps from clogging or damage, may precede pumps handling raw sewage;
4.4.b.7.B. Where the size of the installation warrants, this rule recommends a mechanically cleaned bar screen with a grinder or comminution device;
4.4.b.7.C. There shall be convenient facilities for handling screenings where screens are located; and
4.4.b.7.D. It is preferable to use duplicate protection units of proper capacity for the larger or deeper sections.
4.4.b.8. Pump Openings.
4.4.b.8.A. Pumps shall be capable of passing 2.5-inch solids or be of the grinder pump type when used in residential developments of 500 persons or less;
4.4.b.8.B. Pumps for all other installations shall be capable of passing three-inch solids or be of the grinder pump type; and
4.4.b.8.C. Pumps shall be non-clog type pumps or ejectors.
4.4.b.9. Priming. The placing of the pump shall be so that under normal operating conditions it shall operate under a positive suction head, except as specified for suction lift pumps.
4.4.b.10. Electrical Equipment. Electrical systems and components such as motors, lights, cables, conduits, switch boxes, and control circuits, in enclosed or partially enclosed spaces, shall be of materials resistant to the environment when usage takes place.
4.4.b.11. Intake. Each pump shall have an individual intake. Wet well design shall be such as to avoid turbulence near the intake.
4.4.b.12. Dry Well Dewatering.
4.4.b.12.A. The dry wells shall have a separate pump in them to remove leakage or drainage with the discharge above the overflow level of the wet well;
4.4.b.12.B. A connection to pump suction may be used as an auxiliary feature;
4.4.b.12.C. Water ejectors connected to a drinking water supply shall not be approved; and
4.4.b.12.D. All floor and walkway surfaces shall have an adequate slope to a point of drainage.
4.4.b.13. Controls.
4.4.b.13.A. Control float cables’ location shall not be affected by the flows entering the wet well or by the suction of pumps;
4.4.b.13.B. Float tubes in dry wells shall extend high enough to prevent overflow;
4.4.b.13.C. A means to automatically alternate the pump in use shall be in place; and
4.4.b.13.D. Pump stations with motors or controls below grade shall have a secure external disconnect switch.
4.4.b.14. Valves and Piping.
4.4.b.14.A. Pumps shall have a full closing valve on the suction piping except on submersible and vacuum primed pumps;
4.4.b.14.B. The installation of a check valve followed by a gate valve on the discharge piping is required; and
4.4.b.14.C. The location of the valves shall not be in a wet well.
4.4.b.15. Ventilation. All dry well installations shall have mechanical ventilation.
4.4.b.15.A. Wet Wells. Ventilation shall be either continuous or intermittent.
4.4.b.15.A.1. If continuous, ventilation shall provide at least 12 complete air changes per hour; and
4.4.b.15.A.2. If intermittent, ventilation shall provide at least 30 complete air changes per hour.
4.4.b.15.B. Dry Wells. Ventilation shall be either continuous or intermittent.
4.4.b.15.B.1. If continuous, ventilation shall provide at least six complete air changes per hour; and
4.4.b.15.B.2. If intermit-tent, ventilation shall provide at least 30 complete air changes per hour.
4.4.b.16. Flow Measurement. There shall be the capability for placing suitable devices for measuring sewage flow at all pumping stations, and the devices shall be placed at critically located pumping stations.
4.4.b.17. Water Supply. There shall be no physical connection between any potable water supply and a sewage pumping station.
4.4.b.18. Alarm Systems. All pump station installations shall equip a high-water alarm light at the lift station.
4.4.b.19. Reliability. At the determination of the Commissioner, emergency power may be a requirement under specific circumstances, such as above water intakes, recreational waters, or other situations.
4.4.b.20. Portable Equipment. In some instances, portable equipment may furnish service to more than one pumping station. However, when using this equipment, it shall have the capability to operate between the wet well and the discharge side of the station. The station shall equip permanent fixtures that shall facilitate rapid and easy connection of lines.
4.4.b.21. Emergency Power Generation. All emergency power generation equipment, if required, shall include instructions indicating the essential need of routinely and regularly starting and running the units at full load.
4.4.c. Suction Lift Pumps.
4.4.c.1. Suction lift pumps shall be of the self-priming or vacuum priming type.
4.4.c.1.A. Self-priming Pumps. Self-priming pumps shall be capable of rapid priming and repriming at the "lead pump on" elevation. Accomplishing the self-priming and repriming shall be automatic under design operating conditions. Suction piping shall not exceed the size of the pump suction and shall not exceed 25 feet in total length. Priming lift at the "lead pump on" elevation shall include a safety factor of at least four feet from the maximum allowable priming lift for the specific equipment at design operating conditions. The combined total of dynamic suction lift at the "pump off" elevation and required net positive suction head at design operating conditions shall not exceed 22 feet.
4.4.c.1.B. Vacuum-priming Pump Stations. Vacuum-priming pump stations shall equip dual vacuum pumps capable of automatically and completely removing air from the suction lift pump. The vacuum pumps shall have adequate protection from damage due to sewage. The combined total of dynamic suction lift at the "pump off" elevation and required net positive suction head at design operating conditions shall not exceed 22 feet.
4.4.c.2. The net positive suction head and specific speed requirements as stated on the manufacturer's pump curve under the most severe operating conditions shall limit the capacity of a suction lift pump.
4.4.c.3. The location of the suction lift pumps shall not be within the wet well.
4.4.c.4. Access to the wet well shall not be through the dry well, and the dry well shall have a gas-tight seal when mounted directly above the wet well.
4.4.d. Submersible Pumps.
4.4.d.1. Pump Removal. Pumps shall be readily removable and replaceable without dewatering the wet well or disconnecting any piping in the wet well.
4.4.d.2. Hoist Provision. The Commissioner may require a submersible pumping facility to have a hoist for removing the pump from the wet well.
4.4.d.3. Electrical Control Location. The location of electrical controls shall be outside the wet well in a suitable housing for protection against weather and vandalism.
4.4.e. Pneumatic Ejectors.
4.4.e.1. Venting. This rule requires the venting of ejector pots to the atmosphere.
4.4.e.2. Duplicate Compressors. There shall be duplicate compressors and consideration shall be given to providing an air storage tank.
4.4.f. Force Mains.
4.4.f.1. Size. Minimum size of force mains to serve facilities having a population of 500 people or less shall be three inches for solids passing pumps. Minimum size of force mains serving populations of over 500 people, shall be four inches for solids passing pumps. Applicant may utilize smaller size force mains in conjunction with grinder pumps.
4.4.f.2. Air Relief Valve. Placement of air relief valves shall be at high points in the force mains.
4.4.f.3. Termination. The force mains shall enter the receiving manhole with its center-line horizontal and with an invert elevation that shall insure a smooth laminar flow transition to the gravity flow section, but in no case shall the force main enter the gravity sewer system at a point more than one foot above the flow line of the receiving manhole.
4.4.f.4. Materials of Construction. The construction of force mains shall be of plastic, ductile iron or cement lined steel pipe bearing the pressure class required by the total dynamic head.
4.4.f.5. Anchoring. Anchoring of the force mains shall be sufficient within the pump station and throughout the line length. The number of bends shall be as few as possible. There shall be thrust blocks, restrained joints, or tie rods where there is a need for restraint.
4.5. Vacuum Sewage Collection Systems.
4.5.a. Main Lines.
4.5.a.1. Materials.
4.5.a.1.A. PVC or ABS of schedule 40 DWV, Class 200, or SDR 21.
4.5.a.1.B. Joints may be either solvent welded, O-ring, or heat fusion joints, that have a specific design to seal against vacuum.
4.5.a.2. Piping.
4.5.a.2.a. Minimum diameter pipe size shall be three inches in the collection system.
4.5.a.2.B. There shall be cleanouts at a maximum of every 200 feet on straight runs and at changes in direction.
4.5.a.2.C. Frost depth or load condition shall dictate how deep to bury the line, but except as allowed on a case-by-case basis by the Commissioner, it shall be no less than three feet deep.
4.5.a.2.D. The system manufacturer shall certify all vacuum system designs.
4.5.a.2.E. The applicant shall utilize the manufacturer's recommendation for reform pockets and lifts.
4.5.a.2.F. Total available head loss from any input point should not exceed 18 feet of water. There shall be a reserve of five feet of water for valve operation.
4.5.a.2.G. Installation of the collection system shall meet the following tightness test specification, "the system shall be vacuumed to 24 inches of mercury vacuum pressure, allowed 15 minutes to stabilize, and thereafter shall not lose more than 1% vacuum pressure per hour over a minimum of a four-hour period." There shall be testing prior to the installation of valves.
4.5.b. House Connections.
4.5.b.1. Pneumatic or electric controllers shall actuate valves. This rule prohibits valve systems that are electrically controlled. Minimum valve size shall be three inches.
4.5.b.2. The location of the valve shall be outside the dwelling. The location of the pipe between the dwelling and valve shall be to provide 10 to 15 gallons storage, or the location of a 30-gallon tank shall be between the dwelling and the valve. This rule requires a permanent maintenance easement for the valve and its appurtenances.
4.5.b.3. Valve boxes shall have a solid bottom and be counter weighted to prevent flotation when located in an area subject to flooding or high ground water. The cover and valve box material shall be of adequate strength to withstand the expected maximum dynamic and static loading conditions. Venting valve boxes shall reduce condensation and shall be constructed of corrosion resistant material.
4.5.b.4. The vent system for the house shall have a diameter of three inches or greater to prevent evacuation of traps during vacuum valve operation. The vent pipe shall extend above the eaves of the house. The commissioner shall consider other methods for venting on a case-by-case basis.
4.5.b.5. Those systems using a pneumatic controller shall have adequate protection of the sensor controllers, and any portion of the controller apparatus vented to atmosphere shall have protection from flooding, screened from insect entry, and provided with rain covers.
4.5.c. Sewage Collection Tanks.
4.5.c.1. The sewage collection tanks shall be of either coated welded steel or fiber glass and shall be vacuum tight.
4.5.c.2. Each inlet to the tank shall have its own shut-off valve.
4.5.c.3. There shall be liquid level sensors installed to operate the discharge sewage pumps, the high-level alarm and to interrupt the electrical power to the vacuum pumps.
4.5.c.4. The size of the collection tank shall be to hold a maximum of 10 minutes design flow. The size of the collection tanks shall be at 1.5 x operating volume or a minimum of 400 gallons.
4.5.d. Vacuum Pumps.
4.5.d.1. There shall be vacuum reserve tanks installed in series between the sewage collection tank and the vacuum pumps.
4.5.d.2. This rule allows for the use of either liquid ring or sliding vane vacuum pumps as long as they are compatible with pumping moist air containing some sewer gases.
4.5.d.3. There shall be a check valve installed between the vacuum reservoir tank and the vacuum pumps.
4.5.d.4. There shall be dual vacuum pumps, each capable of handling the load, and emergency back-up power.
4.5.d.5. Venting the vacuum pump exhaust outside the building is a requirement. If there is a possibility of objectional odors due to proximity of inhabited dwellings, the evacuation line from the vacuum reserve shall have carbon absorption.
4.5.e. Sewage Pumps.
4.5.e.1. There shall be dual pumps, each capable of handling 2.5 times the average daily flow.
4.5.e.2. There shall be emergency back-up power to operate the entire system.
4.5.e.3. The sewage pumps shall be capable of meeting the NPSH requirements as dictated by the vacuum conditions in the sewage collection tanks.
4.5.e.4. There shall be shut-off valves so that each pump can be isolated for repairs.
4.5.e.5. The discharge piping shall incorporate a check valve/gate valve arrangement such as utilized in a conventional pump station.
4.5.e.6. High level alarms and loss of vacuum alarms shall be capable of transmitting to three or more responsible parties.
4.5.f. Design Requirements.
4.5.f.1. It is a requirement to submit hydraulic calculations for the vacuum mains and force mains with the application.
4.5.f.2. It is a requirement to submit plans and profiles of all mains. Profiles shall indicate depth to mains, and plans shall indicate all valves.
4.5.f.3. When these standards are not applicable, it is a requirement to follow the manufacturer’s recommendations.
4.5.g. Maintenance and Operation.
4.5.g.1. Factory trained maintenance personnel employed by the entity shall be available 24 hours per day.
4.5.g.2. An applicant shall keep an inventory of parts including spare valves, controllers, valve pits, and others.
4.5.g.3. This rule does not allow mixing of equipment such as different makes and models, for a specific project.
4.5.h. Miscellaneous.
4.5.h.1. Collection stations shall equip ventilators and heater dehumidifiers.
4.5.h.2. Branch lines shall have individual cut off valves to allow isolation of the line for repair. Main line sections shall have isolation valves no less than 2,000 feet apart.
4.5.h.3. Consideration to lessen the size of the treatment units in new systems that utilize water saving devices such as vacuum toilets, shall be based upon review and approval by the Commissioner.
4.5.h.4. Retaining spare controllers, valves, and sensors shall be on a basis of one per each 15 units installed.
4.5.h.5. House vent stacks shall be at least three inches in diameter. If necessary, there shall be an installation of a three- to four-inch stack on the gravity sewer lateral adjacent to the house wall.
4.5.i. Relation of vacuum lines to water lines shall be as for gravity lines. See paragraph 4.2.s.4. of this rule.
4.6. Pressure Sewage Collection System.
4.6.a. General.
4.6.a.1. Simplex units shall serve no more than three residences. Duplex units shall serve no more than 10 residences. Other multiple source applications require approval by the Commissioner. This rule requires spare pumps.
4.6.a.2. Types of Pressure Systems.
4.6.a.2.A. Grinder Pump Pressure System.
4.6.a.2.B. Septic Tank Effluent Pumping Pressure System.
4.6.a.3. Types of Pumps.
4.6.a.3.A. Submersible, Centrifugal Grinder Pumps. Pumps shall be readily removable and replaceable without dewatering the wet well.
4.6.a.3.B. Semi-Positive Displacement Grinder Pumps. Pumps shall be readily removable and replaceable without dewatering the wet well. There shall be pressure relief valves unless the Commissioner approves another means of pressure relief.
4.6.a.3.C. Non-Clog Submersible Centrifugal Effluent Pumps.
4.6.b. Design Requirements.
4.6.b.1. Hydraulic Calculations. Submitting calculations with the application is a requirement.
4.6.b.1.A. The determination of peak flows shall be from the manufacturers recommendations based upon the pumping equipment the system is using.
4.6.b.1.B. There shall be head losses due to valves and fittings.
4.6.b.1.C. For purposes of calculation, using a C=100 in the Hazen-Williams Formula for all pipe, except for using a C=120 for plastic pipe is a requirement.
4.6.b.1.D. Design velocity shall be in the range of two to five feet per second.
4.6.b.1.E. Computed design life of the pumps shall be on the basis of 10 years.
4.6.b.2. Plans. Submitting plans and profiles of all pressure mains is a requirement. Profiles shall indicate depth of pressure mains. The plans shall indicate all valves.
4.6.b.3. Design. The design shall be in accordance with the standards herewith stated, except when not covered by this standard, then following the manufacturer's recommendations is a requirement.
4.6.c. Pressure Mains.
4.6.c.1. Type. Minimum Pressure Rating - PVC SDR 21, Schedule 40, or PVC SDR 26 may be used.
4.6.c.2. Size. The minimum size service line from the grinder pump to the collection main shall be one and 1.25 inches.
4.6.c.3. Valves and Cleanouts.
4.6.c.3.A. Valving mains shall occur at junctions in order that segments of the system may be taken out of service for maintenance.
4.6.c.3.B. Cleanouts shall be at junctions so that lines may be cleaned.
4.6.c.3.C. The placement of cleanouts with valves shall be at every 400 to 600 feet on straight runs.
4.6.c.3.D. The location of cleanouts and valves shall be at changes in direction of the lines.
4.6.c.3.E. There shall be air release valves at high points in the line.
4.6.c.3.F. There shall be ball or gate valves with cleanouts at the ends of lines.
4.6.c.3.G. There shall be a method of providing continuity of service for main collector lines.
4.6.c.4. Thrust Blocks. There shall be concrete thrust blocks at changes in direction and at "T" junctions.
4.6.c.5. Flushing. This rule requires using one of the following methods:
4.6.c.5.A. Flush tanks of 1,000 gallons capacity with pumps at the ends of lines;
4.6.c.5.B. Water hydrants with backflow preventers at the end of lines, the backflow preventer shall be of the reduced pressure type and shall be non-removable; or
4.6.c.5.C. Water tank truck with pumps.
4.6.c.6. Relation to water lines shall be as for gravity lines. See paragraph 4.2.s.4. of this rule.
4.6.d. Grinder Pump Pressure System.
4.6.d.1. Location.
4.6.d.1.A. The location of the pump station shall be outside the residence or commercial building.
4.6.d.1.B. The location of the control box for a single residence unit shall be on the outside of the building, preferably with the pump station.
4.6.d.1.C. For duplex grinder pump stations, the location of the control box shall be with the pump station.
4.6.d.2. Electrical.
4.6.d.2.A. Control panels shall be of the NEMA type 3 or 4 enclosure.
4.6.d.2.B. The pump and float electrical controls shall have provisions for disconnection without entering the main control box.
4.6.d.3. Alarms.
4.6.d.3.A. When using a single unit grinder pump station, there shall be a high-water alarm light outside the residence.
4.6.d.3.B. When using a dual grinder pump station, there shall be an alarm light at the control box by the pump station.
4.6.d.4. Emergency Holding.
4.6.d.4.A. An existing septic tank may act an emergency holding tank.
4.6.d.4.B. In areas of frequent power outages of a duration of more than four hours each, the installation of emergency holding tanks of 200 gallons capacity is a requirement.
4.6.d.5. Sequence of Connections. The sequence of valves, pump, and other appurtenances from the residence to the collection force main shall be as follows: four-inch sewer line, gate valve, pump, check valve, gate valve, and connection line with 45-degree bend in the direction of flow.
4.6.d.6. Check and Gate Valves.
4.6.d.6.A. Check or gate valves shall be either plastic or bronze.
4.6.d.6.B. Check valves may be either swing check or ball type. If using swing type check valves, construction of a one- to two-foot horizontal run of straight pipe on the downstream side of the check valve is a requirement.
4.6.d.7. Level Controls. Level controls in the pump station shall be either mercury magnetic switches, mercury switches, or pressure switches.
4.6.e. Septic Tank Effluent Pressure Systems.
4.6.e.1. Location. Same as Submersible Pumps. See subdivision 4.4.d. of this rule.
4.6.e.2. Controls.
4.6.e.2.A. Control panels shall be NEMA type 3 or 4 enclosure.
4.6.e.2.B. The pump and float controls shall have provision for disconnection without entering the main control box.
4.6.e.3. Alarms. Same as Grinder Pump Pressure Systems. See paragraph 4.6.d.3. of this rule.
4.6.e.4. Sequence of Connections. The sequence of valves, pump, and other appurtenances from the residence to the collection force main shall be as follows: four-inch sewer line, septic tank, pumping chamber with pump, check valve, gate valve and connection to main collection line with 45- degree bend in direction of flow.
4.6.e.5. Check and Gate Valves. Same as paragraph 4.6.d.6. of this rule.
4.6.e.6. Level Controls. Same as paragraph 4.6.d.7. of this rule.
4.6.e.7. There shall be provisions for the treatment of septage at the plant. There shall be a provision for a septic tank pumping vehicle.
4.6.f. Maintenance and Operation.
4.6.f.1. In the interest of obtaining proper maintenance and operation on a pressure sewer system, the applicant shall be either:
4.6.f.1.A. Under the jurisdiction of a public entity;
4.6.f.1.B. Under the jurisdiction of a private company regulated by the public service commission; or
4.6.f.1.C. Under the jurisdiction of a property owners association.
4.6.f.2. Maintenance personnel employed by an entity operating a pressure system shall attend a factory training course on maintenance and operation of the proposed units.
4.6.f.3. For maintenance needs, this rule recommends a truck provided with a hoist.
4.6.f.4. This rule requires permanent maintenance easements if the location of the pumping equipment and other appurtenances is on private property.
4.6.f.5. An applicant shall keep spare parts, such as air relief valves, gate valves, and relay switches in inventory.
4.6.f.6. This rule does not allow mixing equipment (makes, models) for a specific project.
4.6.f.7. An applicant shall provide spare pumps in the initial design according to Table 64-47-D. at the end of this rule.
W. Va. Code R. § 64-47-5 Sewage Treatment Works
5.1. General.
5.1.a. The design of sewage treatment plants shall be to provide for an estimated population on July 1, 2042. The design of all treatment plants shall be so that their capacity can readily be increased except when circumstances preclude the probability of expansion.
5.1.b. Plant Location. A sewage treatment plant site shall be as far as practical from any present area being built-up or any area that shall probably be built up within a reasonable future period. There shall be a buffer zone as indicated in Table 64-47-E. at the end of this rule, from any surrounding occupied structure to any new plant site. These buffer zone requirements do not apply to existing treatment works that are being upgraded or expanded. The direction of prevailing winds shall be considered when selecting the plant site. The location of the plants operational units shall be at an elevation that is not subject to the 100-year flood or shall otherwise be adequately protected against 100-year flood damage. The plant shall remain fully operational during a 25-year flood. The plant shall be readily accessible in all seasons. The site shall be of sufficient size to accommodate expansion or addition of facilities to increase the degree of treatment.
5.1.b.1. The Commissioner may wave buffer zone requirements shown in Table 64-47-E. upon receipt of a written request by the applicant and a detailed review by the Commissioner to determine any public health impact. Health, safety, and nuisance considerations shall be the basis of establishing a buffer zone.
5.1.b.2. The distances set forth in Table 64-47-E. are distances to sewage treatment units such as aeration basins, clarifiers, sludge holding tanks, chlorination basins, chlorinator rooms, blower houses and other units as stated in Table 64-47-E. Other buildings that may be part of the plant but are only used for storage or as a laboratory and do not contain chlorine cylinders or blowers, shall not be considered a sewage treatment unit and shall not be subject to buffer zone requirements.
5.1.c. Quality of Effluent.
5.1.c.1. Surface Water Discharge. The stream standards and water quality criteria established by the water resources board and effluent limitations established by the division of water resources shall be the basis of the required degree of wastewater treatment. The Commissioner may establish more stringent requirements if the location of a public water supply intake, a recreational water use area, or an aquaculture is downstream from the discharge point.
5.1.c.2. Land Discharge. See subsection 5.19 of this rule.
5.1.c.3. New Processes, Methods and Equipment. The policy of the Commissioner is to encourage the development of new processes, methods, and equipment for sewage treatment. The Commissioner may require the following:
5.1.c.3.A. Monitoring observations, including test results and engineering evaluations, demonstrating the efficiency of these processes;
5.1.c.3.B. Detailed description of the test methods;
Testing, including appropriately composited samples, under various ranges of strength and flow rates, including daily variations, and waste temperatures over a sufficient length of time to demonstrate performance under climatic and other conditions that the system may encounter in the area of the proposed installations;
5.1.c.3.D. Testing and evaluations made under the supervision of a competent process engineer other than those employed by the manufacturer or developer; and
5.1.c.3.E. A performance bond.
5.1.d. Design.
5.1.d.1. Industrial Wastes. When treating industrial and institutional wastes in a sewage treatment works, the character of the wastes in the design of the plant shall be considered. In these cases, the Commissioner may require treatability studies on the composite wastewater prior to the plant design.
5.1.d.2. Hydraulic Loading. The design of treatment plant units shall be based on the average rate of sewage flow per 24 hours, except where there are notations of significant deviations from the normal daily flow pattern.
5.1.d.3. Existing Sewage Systems. When there are existing sewers, there shall be a determination as to the volume and strength of sewage flow. Obtaining these data shall be from actual flow measurements, preferably for both wet and dry weather periods. There shall be laboratory analysis made on flow proportional composite samples taken over 24-hour periods. The design of plans and specifications for sewage works to serve existing sewage systems shall be on the basis of characteristics and strength of sewage as shown by results of composite samples examined and gaugings of the present flow plus allowance for estimated increase in population. In addition, they shall include non-excessive infiltration/inflow.
5.1.d.4. New Sewage Systems. For the construction of new sewers, design plans for sewage treatment works shall be made on the basis of 70 gallons per capita per day or estimates based upon a minimum one year fully documented analysis of water use records adjusted for consumption and losses.
5.1.d.5. Organic Loading. Computation of the design organic loading shall be in the same manner used in determining design flow. Generally, computation of organic loading shall be at 0.17 pounds of five-day BOD per person per day. For package sewage treatment plants, recirculating sand filter systems, stabilization ponds, aerated ponds, and individual sewer systems, treating 50,000 G.P.D. or less, the organic loading design shall increase if proposing garbage grinders.
5.1.d.6. Conduits. The design of all piping and channels shall be to carry the maximum expected flows. The design of the incoming sewer shall be for free discharge. Filleting bottom corners of the channels is required. Eliminating pockets and corners where solids can accumulate is also required. There shall be suitable gates in channels to seal off unused sections that might accumulate solids. The use of shear gates or stop planks shall receive approval when using them in place of gate valves or sluice gates.
5.1.d.7. Arrangement of Units. Arrangement of component parts of the plant shall be for greatest operating convenience, flexibility, economy, and so as to facilitate installation of future units. There shall be multiple treatment units for plants greater than 100,000 gallons in size. There shall be a provision for appurtenances in such a manner that it is possible to temporarily take any unit of service. The remainder of the plant shall be operational with the unit or units out of service. In the case of oxidation ditches, if multiple rotors exist, the above requirements shall be met.
5.1.e. Miscellaneous.
5.1.e.1. Provisions for Taking Units Out of Service. Diversion piping and structures shall be properly located and arranged so that it is possible to independently remove either dual or multiple units of the plant from service for inspection, maintenance, and repairs.
5.1.e.2. Dewatering. There shall be means to dewater each unit. The possible need for hydrostatic pressure relief devices shall be considered.
5.1.e.3. Construction Materials. Because of the possible presence of hydrogen sulfide and other corrosive gases, greases, oils, and similar constituents frequently present in sewage, the materials selected for use in sewage treatment works shall be considered. This is particularly important in the selection of metals and paints. It is essential to avoid using dissimilar metals to minimize galvanic action. Cathodic protection is a requirement for all steel tanks.
5.1.e.4. Covering Units. The use of properly vented covers shall receive approval.
5.1.e.5. Painting. It is important to avoid the use of paints containing lead or mercury. In order to facilitate identification of piping, this rule suggests that the different lines be color-coded. The contents shall be stenciled on the piping in a contrasting color. The color scheme is only required for plants of over 100,000 gallons in size. For purposes of standardization, Table 64-47-F. at the end of this rule contains the recommended color scheme.
5.1.e.6. Operating Equipment. The specifications shall include a complete outfit of tools and accessories for the plant operator's use, such as squeegees, wrenches, valve keys, rakes, shovels, etc. A portable pump is recommended. There shall be readily accessible storage space and work bench facilities and consideration given to provision of a garage area that would also provide space for large equipment, maintenance, and repair.
5.1.e.7. Grading and Landscaping. There shall be concrete, asphalt or gravel walkways for access to all units. Where possible, it is important to avoid steep slopes to prevent erosion. Surface water shall not drain into any unit. There shall be particular care taken to protect trickling filter beds, sludge beds, and intermittent sand filters from surface water. There shall be a provision for landscaping, particularly when a plant location must be near residential areas.
5.1.f. Plant Outfalls.
5.1.f.1. Outlet. The outfall sewer, where practical, shall extend to the low water level of the receiving body of water in a manner to insure satisfactory dispersion of the effluent. It shall not have its outlet submerged and there must be provisions for taking samples of the effluent discharge. This rule permits the use of headwalls where adequate dispersion is obtained without carrying the outfall into the stream.
5.1.f.2. Design and Construction. The construction of the outfall sewer shall be as to protect it against the effects of flood water, ice, or other hazards as to reasonably insure its structural stability and freedom from stoppage.
5.1.g. Essential Facilities.
5.1.g.1. Emergency Power.
5.1.g.1.A. General. All sewage treatment facilities greater than 100,000 gallons in size that require electrical power, shall have an alternate source of electric power to allow continuity of operation during power failures, except as noted below. Methods of providing alternate sources include:
5.1.g.1.A.1. The connection of at least two independent public utility sources, such as substations. This rule recommends a power line from each substation, and it shall be a requirement unless the reviewing agency receives verifying documentation and approves that a duplicate line is not necessary to minimize water quality violations;
5.1.g.1.A.2. Portable or in-place internal combustion engine equipment that shall generate electrical or mechanical energy; and
5.1.g.1.A.3. Portable pumping equipment when only emergency pumping is required.
5.1.g.1.B. Power for Aeration. Standby generating capacity is not a requirement for aeration equipment used in the activated sludge process. When power outages of four hours or more are common, auxiliary power for minimum aeration of the activated sludge is a requirement. The reviewing authority may require full power generating capacity on certain critical stream segments.
5.1.g.1.C. Power for Disinfection. There shall be continuous disinfection, when required, during all power outages.
5.1.g.2. Electrical Equipment. The location of all electrical equipment such as motors and local controls, and electrical conduits shall either be at an elevation above the 100-year flood level or be of waterproof design. There shall be adequate protection for all outdoor equipment from the weather. Motors located indoors, and near liquid handling piping and equipment, shall be of splashproof design. All electrical wires in underground conduits or in conduits that can flood shall have water resistant insulation as identified in the National Electrical Code.
5.1.g.3. Water Supply.
5.1.g.3.A. General. There shall be an adequate supply of drinking water for use in the laboratory and general cleanliness around the plant. No piping or other connections shall exist in any part of the treatment works that, under any condition, might cause the contamination of a drinking water supply. There shall be an examination of the chemical quality for suitability for the intended use in heat exchangers, chlorinators, and other units.
5.1.g.3.B. Direct Connections. The drinking water supply line to each treatment plant shall have, as a minimum, an approved reduced pressure type backflow preventer. The installation of these devices shall be in a location to prevent flooding, corrosion and allow for adequate, quick service and periodic inspections. Installation in below-grade meter type vaults is not acceptable. All water supply take-off points shall follow the devices and, there shall be no allowance for extension of this line to serve the public.
5.1.g.3.C. Indirect Connection. When using a potable water supply for any purpose in a plant, there shall be provisions for a break tank, pressure pump, and pressure tank. Water shall discharge to the break tank through an air-gap at least six inches above the maximum flood line or the spill line of the tank, whichever is higher. There shall be a permanently posted sign at every hose bibb, faucet, or stop clock located on the water system beyond the break tank to indicate that the water is not safe for drinking.
5.1.g.3.D. Separate Drinking Water Supply. When it is not possible to provide drinking water from a public water supply, there shall be a separate well. Location, construction, and testing of the well shall comply with requirements of the Bureau. Requirements governing the use of the supply are those contained in subparagraphs 5.1.g.3.B. and 5.1.g.3.C. of this rule. Prior to construction, an applicant shall obtain approval of the supply from the Commissioner.
5.1.g.3.E. Separate Non-Drinking Water Supply. When there is a provision for a separate non-drinking water supply, there shall be posting of a permanent sign indicating the water is not safe for drinking to stop cocks, hose bibbs, and other water outlets.
5.1.g.4. Sanitary Facilities. All sewage treatment plants with laboratory facilities shall have a shower, toilet, and lavatory. There shall also be a provision for locker facilities.
5.1.g.5. Sewage Flow Measurement. There shall be facilities for measuring the volume of sewage flows at all treatment works greater than 100,000 gallons in size. All plants having a capacity of greater than 100,000 gallons per day shall equip indicating, recording, and totalizing equipment for effluent flow measurement.
5.1.g.6. Floor Slope. There shall be adequate floor surface slope to a point of drainage.
5.1.g.7. Stairways. The installation of stairways shall be with a slope of 30 to 35 degrees from the horizontal to facilitate carrying samples, tools, and other necessaries. All risers in a stairway should be of equal height. All stairways shall have handrails.
5.1.h. Safety. Following are the minimum requirements for all plants:
5.1.h.1. Enclosure of the wastewater treatment works with a minimum six feet high chain link fence with a locked entrance gate designed to discourage the entrance of unauthorized persons and animals. In lieu of a chain link fence, a barbed wire fence with a locked entrance gate can enclose natural systems, such as stabilization ponds, polishing ponds, and wetlands.
5.1.h.2. There shall be handrails, grating, and guardrails installed for safety when installed in open basins, screen channels, mechanical equipment, and other hazardous places. For all extended aeration plants of 50,000 gallons per day or less grating is a requirement.
5.1.h.3. Provision of first-aid equipment.
5.1.h.4. Posting of "No Smoking" signs in hazardous locations.
5.1.h.5. Provision of protective clothing and equipment such as SCBA’s, atmospheric testers and gloves.
5.1.h.6. Provision of portable blower and sufficient hose.
5.1.h.7. There shall be explosion proof electrical equipment and non-sparking tools in work areas where hazardous conditions may exist, such as digester vaults and other locations where potentially explosive atmospheres of flammable gas or vapor accumulate.
5.1.h.8. Proper grounding and insulation of all electrical wiring is a requirement. There shall be no part of the plant piping used for grounding.
5.1.h.9. There shall be a provision for portable lighting equipment.
5.1.h.10. All manhole steps shall have slip-proof rungs and the steps shall be of the railroad type that shall help prevent foot slippage off the ends of the rungs.
5.1.h.11. There shall be a provision for separate storage located remotely from the plant for flammable and hazardous material.
5.1.h.12. The location of heating devices with open flames shall be in separate rooms with outside entrances and at grade or above.
5.1.h.13. Installation of particular safety precautions for gas-collection piping is a requirement.
5.1.h.14. There shall be adequate ventilation.
5.1.h.15. Chlorinator rooms and chlorine storage areas shall have heat, light, and a ventilation fan that is capable of being turned on from outside the room. The room shall be at grade or above. There shall be a provision a viewing window from the plant interior; and
5.1.h.16. The treatment works shall comply with the provisions of the Occupational Safety and Health Act (OSHA).
5.1.i. Laboratory Space. All treatment works shall have facilities, either contractual or on-site, for making the necessary analytical determinations and operating control tests. When using an on-site laboratory, isolation shall be done to render the laboratory reasonably free from the adverse effects of noise, heat, vibration, and dust. Minimum laboratory space for facilities not performing BOD and suspended solids testing on-site shall be 100 square feet floor space with 35 square feet bench area. Facilities providing on-site BOD, suspended solids, and fecal coliform analysis shall provide a minimum of 400 square feet of floor space and 150 square feet of bench space. If more than two persons shall be working in the laboratory at any given time, there shall be a provision of 100 square feet of additional space for each additional person. Advanced wastewater treatment plants shall provide a minimum of 100 additional square feet of floor space with proportionate increase in bench space. Lists of laboratory equipment shall be compiled from USEPA approved latest edition of Standard Methods for the Examination of Water & Wastewater, by APHA - AWWA - WPCF.
5.1.j. Laboratory Equipment. All treatment works shall have laboratory equipment determined by the commissioner based upon type and complexity of the treatment process. However, all extended aeration treatment plants of 100,000 gallons per day or less shall have the following:
5.1.j.1. A test kit for pH and for chlorine residual. This test kit shall be of the comparator type as manufactured by Hach, Taylor, Hellige, or Wyandotte;
5.1.j.2. Two one-liter graduated beakers;
5.1.j.3. A secchi disk; and
5.1.j.4. A squeegee with proper length of handle, five-quart bucket and rubber gloves.
5.2. Screening Devices and Comminutors.
5.2.a. Bar Racks and Screens.
5.2.a.1. Either coarse bar racks or bar screens shall provide protection for pumps and other equipment. Coarse bar racks shall provide protection for comminutors.
5.2.a.2. Location.
5.2.a.2.A. Indoors. Screening devices, installed in a building where there is other equipment or offices located, should be accessible only through a separate outside entrance.
5.2.a.2.B. Outdoors. Screening devices installed outside shall have protection from freezing.
5.2.a.2.C. Access. Screening areas shall have stairway access, lighting and ventilation, and a convenient means for removing the screenings.
5.2.a.3. Design and Installation.
5.2.a.3.A. Bar Spacing. Clear openings between bars shall be no less than one inch for manually cleaned screens. Clear openings for mechanically cleaned screens may be as small as 0.5 inch. Maximum clear openings shall be 1.75 inches.
5.2.a.3.B. Slope. The placement of manually cleaned screens, except those for emergency use, shall be on a slope of 30 to 45 degrees from the horizontal.
5.2.a.3.C. Velocities. At normal operating flow conditions, approach velocities shall be no less than 1.25 feet per second, to prevent settling; and no greater than 3 feet per second through the bar screen to prevent forcing material through the openings.
5.2.a.3.D. Channels. For plants of greater than 100,000 gallons per day, there shall be a provision for dual channels and equipped with the necessary gates to isolate flow from any screening unit. There shall also be provisions to facilitate dewatering each unit. The shape of the channel preceding and following the screen shall be to eliminate stranding and settling of solids. Channels shall be three to six inches below the invert of the incoming sewer.
5.2.a.3.E. Mechanical Devices. A positive means of locking out each mechanical device shall be a provision.
5.2.a.4. Control Systems.
5.2.a.4.A. Timing Devices. All mechanical units without timing devices shall run continuously. All mechanical units operated by timing devices shall have auxiliary control that shall set the cleaning mechanism in operation at predetermined high-water elevations.
5.2.a.4.B. Electrical Fixtures and Controls. Electrical fixtures and controls in screening areas where explosive gases may accumulate shall meet the requirements of the National Electrical Code for Class 1, Group D, Division 1 locations.
5.2.a.4.C. Manual Override. A manual override shall supplement automatic controls.
5.2.a.5. Auxiliary Screens. When using mechanically operated screening or comminuting devices, there shall be a provision for auxiliary manually cleaned screens. Design shall include provisions for automatic diversion of the entire sewage flow through the auxiliary screens should the regular units fail.
5.2.a.6. Fine Screens. The use of fine screens in lieu of sedimentation is not permitted. In special cases, if demonstrated that the features peculiar to fine screens may be advantageous, the Bureau may approve the proposed installation on a case-by-case basis.
5.2.a.7. Disposal of Screenings. There shall be facilities for removal, handling, storage, and disposal of screenings in a sanitary manner. Manually cleaned screening facilities shall include an accessible platform from which the operator may rake screenings easily and safely. There shall be a provision for suitable drainage facilities for both the platform and storage areas. This rule prohibits grinding of screenings and return to the sewage flow. This rule prohibits open area disposal. The commissioner shall approve the manner in which applicant buries screens or if permitted, applicant may place them in a landfill.
5.2.b. Comminutors.
5.2.b.1. Location. The location may be a requirement at sewage treatment plants forty thousand (40,000) gallons or greater in size. The location of comminutors shall downstream of any grit removal equipment.
5.2.b.2. Size. The design of comminutors shall be to handle peak flow.
5.2.b.3. Installation. There shall be a bar screen bypass channel. The use of the bypass channel should be automatic at depths of flow exceeding the design capacity of the comminutor.
5.2.b.4. Servicing. There shall be a provision to facilitate servicing units in place and removing units from their location for servicing.
5.2.b.5. Macerators and Grinder Pumps. In lieu of comminutors, applicant may use macerators and grinder pumps or similar devices upon approval by the Commissioner.
5.3. Grit Removal.
5.3.a. General. There shall be grit removal facilities for all sewage treatment plants serving combined sewer systems. There shall be provision made for future installation of grit removal facilities for all plants of greater than 100,000 gallons in size serving new sanitary sewer systems. Grit removal facilities may be a requirement for new plants serving existing sewer systems. All sewage treatment plants having anaerobic digesters require grit removal.
5.3.b. Location. The location of grit removal facilities, except in unusual circumstances shall be ahead of pumps and comminuting devices, and coarse bar racks should be placed ahead of mechanically cleaned grit removal facilities.
5.3.c. Type and Number of Units. Grit removal facilities for plants treating wastes from combined sewers shall have at least two manually cleaned units or one mechanically cleaned unit and one manually cleaned unit. Facilities other than channel-types are desirable for plants 100,000 gallons or greater in size, if provided with flexible controls for agitation or air supply devices and with grit removal equipment.
5.3.d. Velocity-Controlled Grit Removal.
5.3.d.1. Inlet. Inlet turbulence shall be minimal.
5.3.d.2. Velocity and Detention. Design of channel-type chambers shall be to provide a velocity of one foot per second. The detention time shall be based on the size of particles (0.21 mm) to be removed. The design should take into consideration undesirable turbulence and velocities at inlets and outlets.
5.3.d.3. Grit Washing. The method of final grit disposal should determine the need for grit washing.
5.3.d.4. Drains. There shall be a provision for dewatering each unit.
5.3.d.5. Water. For clean up purposes, there shall be an adequate supply of water under pressure.
5.3.d.6. Grit Removal. Grit removal facilities located in deep pits shall have mechanical equipment for pumping or hoisting grit to ground level. The pits shall have a stairway, elevator or manlift, ventilation, and lighting, and have a means of drainage.
5.3.e. Aerated Grit Removal.
5.3.e.1. Air Diffusers. The location of air diffusers shall be on one side of the tank, two to three feet above the tank bottom.
5.3.e.2. Air Supply Rate. There shall be a detention time of three minutes.
5.3.e.3. Inlet and Outlet. Design of the aerated grit chamber shall be such as to prevent short circuiting at the inlet and outlet. The inlet to the chamber shall introduce the wastewater directly into the circulation pattern caused by the air diffusion. The outlet shall be at a right angle to the inlet and a baffle installed near the outlet.
5.3.e.4. Grit Removal. The aerated grit chambers shall have mechanical grit removal equipment.
5.3.f. Grit Handling. Grit handling areas should have impervious surfaces with drains. If transporting grit, the design of the conveying equipment should be to avoid loss of material and to provide protection from freezing.
5.3.g. Grit Disposal. The Commissioner shall approve in advance the manner in which an applicant buries grit or if permitted, applicant may place it in a landfill.
5.4. Pre-aeration.
5.4.a. General. Pre-aeration of sewage to reduce septicity may be a requirement in special cases.
5.5. Flow Equalization.
5.5.a. General. There shall be flow equalization when there are expectations of large daily variations in organic or hydraulic loadings.
5.5.b. Location. The location of equalization basins shall be downstream of pretreatment facilities such as bar screens, comminutors, and grit chambers.
5.5.c. Type. There may be a provision for flow equalization by using separate basins or on-line treatment units, such as aeration tanks. The design of equalization basins may be as either in-line or side-line units.
5.5.d. Design.
5.5.d.1. Mixing. Mixing requirements for normal raw domestic wastewaters shall range from 0.02 to 0.04 hp/1000 gallons of maximum storage volume.
5.5.d.2. Aeration. Maintaining a minimum of 1.0 mg/1 of dissolved oxygen in the mixing basin at all times is required. Air supply rates shall be a minimum of 1.25 cfm/1000 gallons of storage capacity.
5.5.d.3. Storage. There shall be sufficient storage to allow the sections of the plant that follow the storage to operate at or at less than their rated design capacity.
5.5.d.4. Detention/Equalization. Basins designed for a combination of storage of wet weather flows and equalization shall have compartments to allow utilization of a portion of the basins for dry weather flow equalization.
5.5.d.5. Flow Discharge Control. There shall be multiple pumping units capable of delivering the desired flow rate from the equalization basin with the largest pumping unit out of service. All pumps, ejectors and air lifts shall be easily removable.
5.5.d.6. Aeration Support. When pumps have floating surface aerators, there shall be provisions to protect the units when dewatering the tank.
5.5.d.7. Basin Cleaning. There shall be facilities to flush solids and grease accumulations from the basin walls.
5.5.d.8. Scum Control. For plants greater than 100,000 gallons in size there shall be a provision for a high-water-level takeoff for withdrawing floating material when using subsurface diffusers.
5.5.d.9. Controls. Controls shall be a provision for plants greater than 100,000 gallons per day. Inlets and outlets for all basin compartments shall suitably equip accessible external valves, stop plates, weirs, or other devices to permit flow control, level control, and the removal of an individual unit from service. Also, there shall be a provision for facilities to measure and indicate liquid levels and flow rates.
5.6. Settling.
5.6.a. Inlets. The design of inlets should be to dissipate the inlet velocity, to distribute the flow equally, and to prevent short-circuiting. The design of channels should be to maintain a velocity of at least one foot per second at one-half design flow. There shall be provisions for eliminating corner pockets and dead ends and use corner fillets or channeling where necessary. There shall be provisions for elimination or removal of floating materials in inlet structures having submerged ports.
5.6.b. Dimensions. The minimum length of flow from inlet to outlet shall be 10 feet unless special provisions are made to prevent short-circuiting. The liquid depth of mechanically cleaned settling tanks shall be as shallow as practicable, but not less than seven feet. Sidewater depth for final clarifiers for activated sludge shall not be less than 12 feet for plants greater than 100,000 gallons in size.
5.6.c. Scum Removal. There shall be effective scum collection and removal facilities, including baffling, ahead of the outlet weirs on all settling tanks. There may be provisions for discharge of scum with the sludge; other provisions may be necessary to dispose of floating materials that may adversely affect sludge handling and disposal.
5.6.d. Weirs. Overflow weirs shall be adjustable. Weir loadings shall not exceed ten thousand 10,000 gallons per day per linear foot for plants designed for average flows of 1.0 mgd or less. Weir loadings for plants designed for flows in excess of 1.0 mgd shall receive special consideration, but these loadings should not exceed 15,000 gallons per day per linear foot. If pumping is a requirement, pump capacity shall relate to tank design to avoid excessive weir loading.
5.6.e. Submerged Surfaces. The tops of beams and similar construction features submerged shall have a minimum slope of 1.4 vertical to 1 horizontal. The underside of these features shall have a slope of one to one to prevent the accumulation of scum or solids.
5.6.f. Multiple Units. Multiple units capable of independent operation shall exist at all plants having a capacity greater than 100,000 gallons per day.
5.6.g. Protective and Servicing Facilities. In plants greater than 100,000 gallons in size all settling tanks shall have a provision for easy access for maintenance, and protection of operators. These features include stairways, walkways, handrails, etc. If side walls extend some distance above the liquid level to provide flood protection for other purposes, there shall be convenient walkways to facilitate housekeeping and maintenance of weirs.
5.6.h. Surface Settling Rates.
5.6.h.1. Primary Settling Tanks. Surface settling rates for primary tanks shall not exceed 1,000 gallons per day per square foot at design flow or 1,500 gallons per day per square foot for peak hourly flows, whichever is larger, for plants having a design flow of 1.0 mgd or less. The Commissioner may permit higher surface settling rates for larger plants.
5.6.h.2. Intermediate Settling Tanks. Surface settling rates for intermediate settling tanks, when using following fixed film reactors, shall not exceed 1,500 gallons per day per square foot based on their design flow.
5.6.h.3. Final Settling Tanks. Surface settling rates for final settling tanks, based on maximum flow rates, shall be as follows:
5.6.h.3.A. Fixed Film Biological Reactors. Surface settling rates for settling tanks following trickling filters or rotating biological contactors shall not exceed 1,200 gallons per day per square foot based on peak hourly flow.
5.6.h.3.B. Activated Sludge. The hydraulic design of intermediate and final settling tanks following the activated sludge process shall be based upon the anticipated peak hourly rate for the area downstream of the inlet baffle. The hydraulic loadings shall not exceed: 1,200 gallons per day per square foot for conventional, step aeration, contact stabilization and the carbonaceous stage of separate-stage nitrification; 1,000 gallons per day per square foot for extended aeration; and 800 gallons per day per square foot for the separate nitrification stage. The solids loading, that includes the return activated sludge (RAS) concentration volume, for all activated sludge processes shall not exceed 50 pounds of solids per day per square foot at the peak rate. Package plants equal to or smaller than 5,000 gallons per day shall have a minimum of eight hours detention time in the clarifier and plants between five thousand 5,000 and 40,000 gallons per day shall have a minimum six-hours detention time in the clarifier, excluding the bottom 2/3 of the hopper.
5.6.i. Freeboard. The walls of settling tanks shall extend at least six inches above the surrounding ground surface and shall provide not less than 12 inches freeboard. Additional freeboard or the use of wind screens is recommended where larger settling tanks are subject to high velocity wind currents that would cause tank surface waves and inhibit effective scum removal.
5.6.j. Scum Removal. Effective scum collection and removal facilities, including baffling, shall exist for all settling tanks. The design shall recognize unusual characteristics of scum that may adversely affect pumping, piping, sludge handling and disposal. There may be provisions for the discharge of scum with the sludge; however, other special provisions for disposal may be necessary.
5.6.k. Sludge Removal. There shall be provisions to permit continuous sludge removal from settling tanks. Final clarifiers in activated sludge plants greater than 0.25 mgd shall have positive scraping devices except for in-basin clarifiers. Each sludge withdrawal line shall be at least four inches in diameter, if pumped, and, if gravity flow, at least six inches in diameter and individually valved. This does not apply to air lift methods of sludge removal rate. Head available for withdrawal of sludge shall be at least thirty 30 inches. There shall be adequate provisions for rodding or backflushing individual pipe runs. Piping shall also exist to return waste sludge to primary clarifiers.
5.6.l. Sludge Hopper. The minimum slope of the side walls shall be 1.7 vertical to 1 horizontal. Hopper wall surfaces shall be smooth with rounded corners to aid in sludge removal. Hopper bottoms shall have a maximum dimension of two feet.
5.7. Activated Sludge.
5.7.a. General. The use of activated sludge process, and its various modifications, shall be permitted where sewage is amenable to biological treatment.
5.7.b. Settling Tanks. The following requirement is in addition to those set forth in subsection 5.6 of this rule:
5.7.b.1. Bypass. When using a primary settling tank, there also shall be a provision for discharging raw sewage directly to the aeration tanks to facilitate plant start-up and operation during the initial stages of the plant design life.
5.7.c. Aeration.
5.7.c.1. Aeration Tanks.
5.7.c.1.A. General. There shall be multiple tanks capable of independent operation for all plants rated at greater than 100,000 gallons per day. The size of the aeration tank for any particular adaptation of the process shall be based on such factors as the size of the plant, degree of treatment desired, sludge age, mixed liquor suspended solids (MLSS) concentration, BOD loading and food to microorganism ratio (F/M). There shall be calculations submitted to justify the basis of the aeration tank capacity and process efficiency. When not submitting process design calculations, it is a requirement to use the aeration tank capacities and permissible loadings for the several adaptations of the processes shown in Table 64-47-G., found at the end of this rule. These values apply to plants receiving peak to average daily load ratios ranging from about 2-to-1 to 4-to-1. Thus, the Commissioner may consider the utilization of flow equalization facilities to reduce the daily peak organic load as justification to approve organic loading rates that exceed those specified in Table 64-47-G.
5.7.c.1.B. Arrangement of Aeration Tanks. The dimensions of each independent mixed liquor aeration tank shall be such as to maintain effective mixing and utilization of air. Liquid depths shall not be less than 10 feet for plants greater than 100,000 gallons per day. For very small tanks or tanks with special configuration, the shape of the tank and the installation of aeration equipment should provide for elimination of short-circuiting through the tank. Table 64-47-G. at the end of this rule contains Permissible Aeration Tank Capacities and Loadings.
5.7.c.2. Inlets and Outlets. Inlets and outlets for each aeration tank unit shall suitably equip valves, gates, stop plates, weirs, or other devices to permit control of the flow and to maintain reasonably constant liquid level. The hydraulic properties of the system shall permit any single aeration tank unit out of service to carry the maximum instantaneous hydraulic load.
5.7.c.3. Conduits. Design of channels and pipes carrying liquids with solids in suspension shall be to maintain self-cleaning velocities or shall agitate to keep the solids in suspension at all rates of flow within the design limits.
5.7.c.4. Measuring Devices. For plants designed for greater than 100,000 gallons per day, there shall be devices installed for indicating flow rates of influent sewage, return sludge and air to each aeration tank. For plants designed for greater than 1,000,000 gallons per day, there shall be devices installed for totalizing, indicating, and recording influent sewage and returned sludge to each aeration tank. Where the design provides for mixing all returned sludge with the raw sewage, or primary effluent, at one location, then measuring the mixed liquor flow rate to each aeration unit is a requirement.
5.7.c.5. Freeboard and Foam Control.
5.7.c.5.A. Aeration tanks shall have a freeboard of at least 18 inches.
5.7.c.5.B. Aeration tanks shall have foam control devises on all plants greater than 10,000 gallons in size. Suitable spray systems or other appropriate means is acceptable. The spray lines shall have provisions for draining to prevent damage by freezing.
5.7.d. Aeration Equipment.
5.7.d.1. General. Design of aeration equipment shall be to supply sufficient oxygen to maintain a minimum dissolved oxygen concentration of 2 mg/l throughout the mixed liquor at all times. Aeration equipment shall be capable of transferring 1.1 lbs. of oxygen per pound of peak BOD applied to the aeration tank with the exception of the extended aeration process for which the value shall be 1.8. There shall be calculations submitted to justify the oxygen requirements and the aeration equipment capacity for plants greater than 100,000 gallons in size.
5.7.d.2. Nitrification. In the case of nitrification, the oxygen requirement for oxidizing ammonia shall be added to the above requirement for carbonaceous BOD removal. Taking the nitrogen oxygen demand (NOD) as 4.6 times the daily peak TKN content of the influent is a requirement. In addition, there shall be consideration given to the oxygen demands due to recycle flows, heat treatment supernatant, vacuum filtrate, elutriates, and others due to high concentrations of BOD and TKN associated with the flows.
5.7.d.3. Controls. There shall be variable air controls to aeration basins. There may be time clocks, variable speed devices or variable depth weirs for the blowers or aerators used. All extended aeration plants shall have a 24-hour time clock graduated in 15-minute intervals.
5.7.d.4. Diffused Air Systems.
5.7.d.4.A. The design of aeration equipment shall be to provide oxygen requirements as set forth in Table 64-47-H. at the end of this rule.
5.7.d.4.B. The requirements above shall include air volume standards for channels, pumps or other air-use demands.
5.7.d.4.C. The specified capacity of blowers or air compressors, particularly centrifugal blowers, shall take into account that the air intake temperature may reach 40 degrees Celsius or 104 degrees Fahrenheit or higher and the pressure shall be less than atmospheric.
5.7.d.4.D. The blowers shall exist in multiple units, for plants of a capacity greater than 20,000 gallons per day in size, so arranged and in such capacities as to meet the maximum air demand with the single largest unit out of service. The design shall also provide for varying the volume of air delivered in proportion to the load demand of the plant.
5.7.d.4.E. The spacing of diffusers shall be in accordance with the oxygenation requirements through the length of the channel or tank and designed to facilitate adjustments of their spacing without major revision to air header piping. The arrangement of diffusers shall also permit their removal for inspection, maintenance, and replacement without dewatering the tank and without shutting off the air supply to other diffusers in the tank.
5.7.d.4.F. Individual assembly units of diffusers shall equip control valves, preferably with indicator markings for throttling or for complete shut-off. Diffusers in any single assembly shall have substantially uniform pressure loss.
5.7.d.4.G. There shall be air filters to prevent clogging of the diffuser system used and to protect the blowers.
5.7.d.5. Mechanical Aeration System.
5.7.d.5.A. The design of the mechanism and drive unit shall be for the expected conditions in the aeration tank in terms of the power performance. Certified testing shall verify mechanical aerator performance.
5.7.d.5.B. A mechanical aeration system shall also accomplish the following:
5.7.d.5.B.1. Maintain all biological solids in suspension.
5.7.d.5.B.2. Meet maximum oxygen demand and maintain process performance with the largest unit out of service. When system capacity is greater than 20,000 gallons per day and when proposing single unit installations, there shall be a provision for a spare aeration mechanism; and
5.7.d.5.B.3. Provide for varying the amount of oxygen transferred in proportion to the load demand on the plant.
5.7.e. Return Sludge Equipment.
5.7.e.1. Return Sludge Rate. The rate of sludge return shall vary by means of variable speed motors, drivers, air lifts or timers to pump sludge. The rate of sludge return expressed as a percentage of the average design flow of sewage shall generally be variable between the limits shown in Table 64-47-I at the end of this rule.
5.7.e.2. Return Sludge Pumps. If using motor driven return sludge pumps, the largest pump out of service shall obtain the maximum return sludge capacity. Pump suctions shall equip a positive head. Pumps shall have at least three-inch suction and discharge openings. If using air lifts for returning sludge from each settling tank hopper, a standby unit is not a requirement provided the design of the air lifts facilitate rapid and easy cleaning and removal and applicant is providing other standby measures. Air lifts shall be at least 2.5 inches in diameter.
5.7.e.3. Return Sludge Piping. Discharge piping shall be at least three inches in diameter and the design shall be to maintain a velocity of not less than two feet per second when return sludge facilities are operating at normal return sludge rates.
5.7.e.4. Waste Sludge Facilities. Waste sludge control facilities shall have a maximum capacity of not less than 25% of the average rate of sewage flow and function satisfactorily at rates of 0.5% of average sewage flow or a minimum of 10 gallons per minute, whichever is larger, for plants greater than 100,000 gallons per day in size. Aerated sludge holding tanks shall exist for all extended aeration plants up to 100,000 gallons per day in size. The design of sludge holding tanks shall be with a minimum capacity of 10% of the average daily design flow.
5.8. Trickling Filters.
5.8.a. Design. The design of filters shall be so as to provide the reduction in carbonaceous and nitrogenous oxygen demand required, and to properly condition the sewage for subsequent treatment processes. The hydraulic loading on standard rate trickling filters shall be between 2,000,000 and 4,000,000 gallons per acre per day with an organic loading equal to or less than 400 pounds of BOD5 per acre foot per day.
5.8.b. Dosing Equipment.
5.8.b.1. Distribution. The sewage distribution may be over the filter by rotary distributors or other suitable devices that permit reasonably uniform distribution to the surface area. At design average flow, the deviation from a calculated uniformly distributed volume per square foot of the filter surface shall not exceed plus or minus 10% at any point.
5.8.b.2. Dosing. Sewage application to the filters may be by siphons, pumps, or by gravity discharge preceding treatment units when suitable flow characteristics have been developed. Application of sewage shall be practically continuous. A piping system that permits recirculation shall be considered.
5.8.b.3. Hydraulics. There shall be careful calculation of all hydraulic factors involving proper distribution of sewage on the filters. For reaction type distributors, a minimum head of 25 inches between low water level in siphon chamber and center of arms is a requirement. There shall be surge relief to prevent damage to distributor seals, where pumping sewage directly to the distributors.
5.8.b.4. Clearance. There shall be a minimum clearance of six inches between media and distributor arms. This rule requires greater clearance where icing occurs.
5.8.c. Media.
5.8.c.1. Quality. The media may be crushed rock, slag, or plastic, or specially manufactured material. The media shall be durable, resistant to spalling or flaking and relatively insoluble in sewage. The top 18 inches shall have a loss by the 20-cycle, sodium sulfate soundness test of not more than 10%, as prescribed by ASCE Manual of Engineering Practice No. 13, "Filtering Materials for Sewage Treatment Plants." The balance to pass a 10-cycle test using the same criteria. Slag media shall be free from iron. Manufactured media shall be structurally stable and chemically and biologically inert.
5.8.c.2. Rock or slag filter media shall have a minimum depth of five feet above the underdrains. Manufactured filter media shall have a minimum depth of 10 feet to provide adequate contact time with the wastewater. Rock or slag filter media depths shall not exceed 10 feet and manufactured filter media depths shall not exceed 30 feet.
5.8.c.3. Size and Grading.
5.8.c.3.A. Rock, slag and similar media shall not contain more than 5% by weight of pieces whose longest dimension is three times the least dimension. They shall be free from thin elongated flat pieces, dust, clay, sand, or fine material and shall conform to the size and grading when mechanically graded over vibrating screens with square openings according to Table 64-47-J at the end of this rule.
5.8.c.3.B. Hand Picked Field Stone. The maximum dimensions of stone shall be five inches; and minimum dimensions of stone shall be three inches.
5.8.c.3.C. Manufactured Media. On a case-by-case basis, the Commissioner shall evaluate applications of manufactured media.
5.8.c.3.D. Handling and Placing of Media. Storage of material delivered to the filter site shall be on wood planks or other approved clean, hard surfaced areas. Rehandling of all material shall take place at the filter site and there shall be no dumping of material into the filter. Rescreening and forking crushed rock, slag, and similar media at the filter site to remove all fines is required. Placement of these material shall be by hand to a depth of 12 inches above the tile so as not to damage the underdrains. The engineer may place the remainder of the material. The engineer shall approve how applicant handles and places manufactured media. There shall be no trucks, tractors, or other heavy equipment driven over the filter during or after construction.
5.8.d. Underdrainage System.
5.8.d.1. Arrangement. Underdrains with semi-circular inverts shall exist and the underdrainage system shall cover the entire floor of the filter. Inlet openings into the underdrains shall have an unsubmerged gross combined area equal to at least 15% of surface area of the filter.
5.8.d.2. Slope. The underdrains shall have a minimum slope of 1%. The design of effluent channels shall be to produce a minimum velocity of two feet per second at average daily rate of application to the filter.
5.8.d.3. Flushing. There shall be a provision for flushing the underdrains. The use of a peripheral head channel with vertical vents is acceptable for flushing purposes. There shall be inspection facilities.
5.8.d.4. Ventilation. The design of the underdrainage system, effluent channels and effluent pipe shall be to permit free passage of air. The size of drains, channels, and pipe shall be such that not more than 50% of their cross-sectional area shall be submerged under the design hydraulic loading. There shall be a provision in the design of the effluent channels to allow the possibility of increased hydraulic loading.
5.8.e. Special Features.
5.8.e.1. Flooding. There shall be provisions in the design of filter structures so that they may flood.
5.8.e.2. Maintenance. The installation of all distribution devices, underdrains, channels, and pipes shall be so that an applicant may properly maintain, flush, or drain them.
5.8.e.3. Freeboard. There shall be a freeboard of four feet or more for tall, manufactured media filters to minimize windblown spray.
5.8.e.4. Flow Measurement. There shall be devices to permit measurement of flow to filter, including recirculated flows.
5.8.e.5. Recirculation. The merits of recirculation for various purposes; for example, to prevent drying of a standard rate filter between dosings shall be considered.
5.8.f. Two-Stage Filters. The use of two-stage filters when single stage filters may not accomplish the required removals shall be considered.
5.8.g. Efficiencies. Calculating and documenting expected efficiencies is required. The effect of climatic conditions on the overall filter performance shall be considered.
5.8.h. Rotary Distributor Seals. This rule does not permit the use of mercury seals. Ease of seal replacement shall be a consideration in design.
5.9. Rotating Biological Contactors (RBCs).
5.9.a. Winter Protection. Year-round operation requires covering of rotating contactors to protect the biological growth from cold temperatures and the excessive loss of heat from the wastewater with the resulting loss of performance. Construction of enclosures shall be of a suitable corrosion resistant material. Windows or simple louvered mechanisms shall be installed that can be opened in the summer and closed in the winter to provide ventilation. To minimize condensation, the enclosure shall have insulation or heat.
5.9.b. Required Pretreatment. Primary settling tanks equipped with scum and grease collecting devices shall precede RBCs. Bar screening or comminution are not suitable as the sole means of pretreatment.
5.9.c. Unit Sizing. Unit sizing shall be based on experience at similar full-scale installations or thoroughly documented pilot testing with the particular wastewater. In determining design loading rates, expressed in units of volume per day per unit area of media covered by biological growth, the following parameters shall be considered:
5.9.c.1. Design flow rate and influent waste strength;
5.9.c.2. Percentage of BOD to be removed;
5.9.c.3. Media arrangement, including number of stages and unit area in each stage;
5.9.c.4. Rotational velocity of the media;
5.9.c.5. Retention time within the tank containing the media;
5.9.c.6. Wastewater temperature;
5.9.c.7. Percentage of influent BOD that is soluble; and
5.9.c.8. In addition to the above parameters, loading rates for nitrification shall depend upon influent total Kjeldahl nitrogen (TKN), influent ammonia nitrogen concentration, pH, and the allowable effluent ammonia nitrogen concentration.
5.9.d. Design Safety Factor. Daily load variations affect effluent concentrations of ammonia nitrogen from the RBC process designed for nitrification. Therefore, it may be necessary to increase the design surface area proportional to the ammonia nitrogen daily peaking rates to meet effluent limitations. An alternative is to provide flow equalization sufficient to insure process performance within the required effluent limitations.
5.9.e. Air Driven Units. This rule does not permit air driven units.
5.10. Sequential Batch Reactor (SBR) and Intermittent Wastewater Treatment Systems.
5.10.a. Batch Reactor. Batch reactor and intermittent treatment technologies shall use an alternating multiple-tank system for new installations. Tank applications for renovating existing treatment works or for facilities with flows equal to or less than 50,000 gallons per day shall be considered on a case-by-case basis, by the Commissioner.
5.10.b. Aeration Devises. Blowers or other aeration devices shall exist in multiple units for treatment works that have a capacity of greater than 20,000 gallons per day. The arrangement and capacity of blowers or other aeration devices shall be as to meet the maximum air demand with the largest single unit out of service.
5.10.c. Diffusers. Individual assembly units of diffusers shall have control valves, preferably with indicator markings for throttling or for complete shutoff.
5.10.d. Design Loadings. Five-day biochemical oxygen demand loading and aeration requirements shall be no less than the requirements specified by the manufacturer for each particular proprietary sequencing batch reactor (SBR) process. An applicant shall obtain written concurrence with the proposed design and specifications for a particular installation from the manufacturer of a proprietary system or technology and shall provide it with the project plans. Generally, an applicant should use an average hydraulic detention time of 24 hours as a basis for design.
5.10.e. Operation. Each unit shall be capable of independent operation during low, average, peak, and storm flow.
5.10.f. Decanting. There shall be provisions to ensure that decanting cannot in any way occur during any phase of operation except at the end of the "settle" or the "idle" phase or period.
5.10.g. Pre-treatment. A mechanically cleaned bar screen having maximum clear openings between the bars of a half inch (closer spacings are encouraged) shall precede SBR treatment plants. Comminutors or other sewage grinders are not acceptable substitutes for this requirement.
5.10.h. Scum Removal. Each unit shall have a means of excluding scum and other floatables from entering the decanter.
5.10.i. Design Flow Rate. The design of downstream units and piping shall be based upon the decanter flow rate, not the design flow of the treatment facilities.
5.11. Recirculating Sand Filters (RSF). The design of RSF systems can be to treat flows as small as those generated by the individual home, up to any size for which engineering considerations and economics would indicate the RSF system to be the optimum choice, when comparing the RSF technology to other candidate technologies.
5.11.a. Design Considerations. All piping used in RSF systems shall comply with collection system piping standards. Appropriate cleanouts or access ports shall be available in all piping, to allow operator access for inspection and maintenance purposes.
5.11.b. General Description. The recirculating sand filter treatment system consists of a septic tank, or Imhoff tank, followed by a recirculation tank, and then an open sand filter. An applicant shall provide a pumping system with time clock control mechanisms to provide a recirculation rate that results in fresh liquid being dosed onto the surface of the sand filter. An applicant shall provide float controls to override the time clocks, if flows increase to the point where overflow is imminent, but the time clock is not yet ready to provide power to the pumps.
5.11.c. Septic Tank/Imhoff Tank Design. The design of septic tanks or Imhoff tanks are to be in accordance with established design standards.
5.11.d. Recirculation Tank. Septic tank or Imhoff tank effluents are directed, by gravity if possible, to a recirculation tank. Normally, the tank size is to be equal to the incoming 24-hour flow, assuming that the organic concentrations are within the range of normal domestic sewage i.e., 150 350 mg/l BOD5. The primary purpose of the recirculation tank is to receive underdrain flows from the sand filter(s), to mix with the septic tank or Imhoff tank effluent. This maintains a positive dissolved oxygen concentration in the recirculation tank, thus eliminating any septic odors from being released when dosing the filters. There shall be a provision for pumps in the recirculation tank to dose the filter(s) on an intermittent basis.
5.11.e. Dosing. A means of dosing the filters can be dosing troughs, spray nozzles, or a central splash pad in the middle of the filter, or a dosing grid system. This rule recommends spray nozzles to optimize distribution onto the filter. All exposed dosing lines shall be self draining to prevent freezing during cold weather periods.
5.11.e.1. Filter dosing normally lasts for several minutes each hour, or half-hour periods. Dosing less frequently than once every two hours is not a recommendation, although applicant may vary the dose interval and dose volume. Dosing shall not occur for more than 50% of a dosing cycle to allow aeration to occur between cycles. This rule recommends a recirculation ratio of at least 12-to-1 (i.e., recirculation ratio equals daily flow dosed onto the filter(s) divided by the average daily flow of sanitary wastes entering the treatment facility). Recirculation ratios up to 25-to-1 may be appropriate, depending on the nature of the wastes being treated.
5.11.e.2. The activation of the recirculation pump(s) shall be by means of a time clock with not greater than 15-minute increment settings. An applicant shall use a 96 pin, 24-hour clock, or another timer approved by the Commissioner.
5.11.e.3. A single recirculation pump is acceptable for a single-family home or smaller RSF system. An RSF system serving a greater design load than a single-family home shall have duplex pumps.
5.11.e.4. This rule recommends volumes equal to one to four inches of depth over the filter during each dosing cycle.
5.11.e.5. Piping between the recirculation tank and filters shall allow dosing of any filter by either duplex pump, via actuation of appropriate valves.
5.11.f. Electrical Controls. All electrical wiring shall be in compliance with the National Electrical Code. This rule recommends a control panel in a NEMA IV housing to preclude damage due to inclement weather conditions unless the location of the controls is inside a secure building.
5.11.f.1. There shall be high and low liquid level control switches (i.e., mercury float switches, or similar) installed in the recirculation tank. The high-level switch shall activate at least one pump by overriding the timer control. The low-level switch shall override the timer control to turn all pumps off. Placement of the high-level switch should be several inches above the normal operating level in the recirculation tank. Placement of the low-level switch should be several inches above the pump intake. Actuation of either the high- or low-level switches shall also cause activation of a visual or audible, or both, alarm indicator to notify the operator of a potential operational problem.
5.11.f.2. Removing pumps and electrical controls (i.e., high- and low-level switches, etc.) located in the recirculation tank, shall be easy via "quick disconnect" piping and electrical connections.
5.11.g. Discharge Valving. The dischargement of treated sewage is only from the filter underdrain piping. All underdrain piping is directed back into the recirculation tank. There shall be a floating ball valve installed inside the recirculation tank. At the maximum operating liquid level in the recirculation tank, the ball valve shall close, and filter effluents shall bypass the tank to disinfection. At lower operating liquid levels, filter effluents shall re-enter the recirculation tank for further treatment.
5.11.h. Filter. Except for a single-family home, all RSF systems shall include at least two filters, with filter alternation accomplished manually. The overall filter area shall be based on a design of ≤ four gallons per day per square foot, based on the average daily sewage flow entering the treatment facility.
5.11.h.1. The filter media shall be silica sand, Black Beauty, graded bottom ash from coal-fired power plants, or other media approved by the Commissioner. Filter media shall have a uniformity coefficient of ≤ 2.5 with an effective particle size of 0.5 to 1.5 mm.
5.11.h.2. The filter media depth shall be ≥ 24 inches, with three layers of support gravel in the underdrain. Support gravel layers shall be ≥ 3 inches for each layer, with support gravel sizes as follows: bottom layer, 1.5 inches to 0.75 inch; middle layer, 0.75 inch to 0.25 inch; top layer 0.25 inch to 0.125 inch.
5.11.h.3. This rule does not recommend the use of a filter fabric between the filter media and support gravel. A filter fabric placed on top of the filter media may reduce maintenance requirements.
5.11.h.4. Placement of perforated underdrain piping shall be at the bottom of the filter prior to placement of the gravel support material. Underdrain piping shall be ≥ 4 inches in diameter or sized based on system hydraulics. Underdrain piping shall lay on a 1% slope, at a spacing of no greater than 10 feet apart. The upper ends of all underdrain piping shall contain an elbow and non-perforated riser pipe that shall terminate halfway between the top of the filter media and the top of the filter sidewalls. The riser pipe shall be available for inspection and maintenance to the underdrain without necessitating excavation of the filter.
5.11.h.5. There shall be a filter sidewall freeboard of 12 inches above the filter media. Filter sidewalls and bottoms shall be impermeable. The slope of the filter bottoms shall be toward the perforated underdrain piping at a grade of one inch vertical to one foot horizontal.
5.11.h.6. Normal operation of a multiple filter RSF system would allow one or more filters to be "at rest" while the filter-in-use operates until "ponding" occurs; after that the applicant manually alternates the filter-in-use. If ponding of a filter does not occur within a one- to two-month period, this rule recommends manual alternation. After ponding occurs on a filter, there shall be an allowance for the filter to rest, the removal of clogging material from the top of the filter, raking the media, and then releveling it as necessary.
5.11.i. Disinfection. Disinfection of the RSF system effluent is required.
5.12. Constructed Wetlands Wastewater Treatment Systems.
5.12.a. The Commissioner shall review constructed wetlands wastewater treatment systems on a case-by-case basis. Recommended design shall be on the basis of the latest edition of the Tennessee Valley Authority's "General Design, Construction, and Operation Guidelines Constructed Wetlands Wastewater Treatment Systems for Small Users Including Individual Residences." Other acceptable designs are the USEPA and NASA wetlands designs.
5.13. Other Biological & Mechanical Systems.
5.13.a. New Biological & Mechanical Treatment Schemes. New biological and mechanical treatment schemes with promising applicability in wastewater treatment may be considered if the applicant provides the required engineering data for new process evaluation in accordance with paragraph 5.1.c.3. of this rule.
5.14. Sewage Stabilization Ponds, Anaerobic Lagoons, and Aerated Lagoons. This rule does permit the use of stabilization ponds, anaerobic lagoons, and aerated lagoons for treatment of raw sewage, primary sewage effluent or secondary sewage effluent.
5.14.a. Stabilization Ponds.
5.14.a.1. Sizing. Stabilization ponds shall have a minimum capacity of 65,000 gallons.
5.14.a.2. Wind Sweep. The location of stabilization ponds shall be to permit an unobstructed wind sweep across the ponds.
5.14.a.3. Water Supply. The location of stabilization ponds shall be a minimum of 300 feet from public water supplies using wells or springs. Maintaining a minimum distance of 600 feet if the public water supply well is down gradient from or lower in elevation than the bottom of the sewage pond is required.
5.14.a.4. Geology and Soils. An applicant shall obtain borings to determine surface and subsurface characteristics of the pond site for all ponds greater than 2.5 acres in size or where required by the commissioner. The soil conservation service, the U.S. Department of Agriculture, requires a soil report for all pond sites.
5.14.a.5. Pond Shape. The shape of all ponds should be such as to produce a uniform perimeter with no coves, islands or peninsulas permitted. Corners of ponds are required to be round. The most desirable shape of ponds is round, square, or rectangular with the length not exceeding three times the width.
5.14.a.6. Design.
5.14.a.6.A. Loading. The design of stabilization ponds shall be on the basis 34 pounds per day of five-day BOD per acre.
5.14.a.6.B. Ponds in Series. If one or more ponds are added in series with the primary pond, the primary pond shall have a minimum volume of 65,000 gallons.
5.14.a.6.C. Depth. Liquid depth of ponds shall be no less than 3.5 feet or greater than five feet. There shall be a three-foot minimum freeboard.
5.14.a.7. Influent Lines.
5.14.a.7.A. Location of Discharge. Influent lines shall extend 10 feet beyond the maximum pond depth and in no case, more than one-fourth the length of the primary stabilization pond. Ponds following the primary pond or secondary treatment facilities in multiple unit systems shall be edge discharging.
5.14.a.7.B. Gravity. Influent lines from gravity collection systems shall discharge at a point 12 to 18 inches above the pond surface.
5.14.a.7.C. Pressure. Pressure influent lines may discharge either above the pond surface or at a point one foot above the pond bottom. When discharging below the pond surface, the end of the pressure line shall rest upon a concrete apron of two square feet minimum size.
5.14.a.7.D. Pipe Support. Piers or other open structures shall support influent lines. This rule does not permit dikes for pipe support.
5.14.a.8. Pond Details.
5.14.a.8.A. Embankments. The construction of embankments shall be of compacted impervious materials with a minimum top width of eight feet. This rule requires the removal of all vegetation from the area upon which the embankment is to be placed.
5.14.a.8.B. Slope. Embankment slopes shall not be steeper than two feet horizontal to one foot vertical. Minimum slopes shall not be flatter than four feet horizontal to one foot vertical.
5.14.a.8.C. Pond Bottom. Pond bottoms shall be level and cleared of all vegetation and debris.
5.14.a.8.D. Watertightness. If soil characteristics are such that seepage shall take place, ponds shall be watertight through use of a pond liner of man-made materials with a minimum thickness of 60 mil required, or clay or through use of a soil additive, approved by the Commissioner.
5.14.a.9. Effluent Lines.
5.14.a.9.A. Discharge. The design of the effluent line shall be to discharge from a point 18 inches below the surface of the pond. There may be a provision to vent the effluent line to prevent siphoning. The effluent line shall discharge on a concrete slab or rip-rap apron. The placement of effluent lines shall be at the furthest point from the influent line discharge.
5.14.a.9.B. Discharge Structure. For ponds greater than 2.5 acres in size, there shall be discharge structures capable of variable depth control. Depth shall be adjustable between 3.5 and five feet in increments of 0.5 foot or less. Spacing of withdrawal points shall be from 18 inches below the surface to 12 inches above the pond bottom discharge structures. Placement of these structures shall be at a point farthest from the influent line discharge and be readily accessible from the embankment.
5.14.a.9.C. Recirculation. Recirculation should be a consideration for multiple pond facilities. When proposing recirculation, thereby reducing pond size, applicant shall submit calculations justifying the proposed reduction to the commissioner for approval.
5.14.a.10. Drain Lines. This rule does not permit drain lines.
5.14.a.11. Miscellaneous.
5.14.a.11.A. Surface Runoff. There shall be a provision to divert storm and surface water around stabilization ponds.
5.14.a.11.B. Fencing. Enclosing ponds with a stock-tight fence a minimum of six feet in height with a locked entrance gate is a requirement.
5.14.a.11.C. Signs. There shall be several signs stating the nature of the facility installed on the fence.
5.14.a.11.D. Prefilling. This rule requires prefilling stabilization ponds with water to a minimum depth of two feet prior to use.
5.14.a.11.E. Access Road. There shall be an all-weather access road to the pond site.
5.14.b. Anaerobic Lagoons.
5.14.b.1. General. Anaerobic lagoons shall generally be used for animal waste treatment.
5.14.b.2. Location. The location of anaerobic lagoons shall be a minimum of 1,500 feet from the nearest occupied structure.
5.14.b.3. Water Supply. Distance from a drinking water supply shall comply with paragraph 5.14.a.3. of this rule.
5.14.b.4. Geology and Soils. These shall comply with paragraph 5.14.a.4. of this rule.
5.14.b.5. Lagoon Shape. This shall comply with paragraph 5.14.a.5. of this rule.
5.14.b.6. Design. Design shall comply with the Waste Treatment Lagoon Code 359, published October 2017 by the USDA Natural Resources Conservation Service.
5.14.c. Aerated Lagoons.
5.14.c.1. General. Aerated lagoon sewage treatment facility shall consist of the following:
5.14.c.1.A. Pretreatment;
5.14.c.1.B. Aeration basin;
5.14.c.1.C. Settling basin, if required; and
5.14.c.1.D. Supplementary treatment, if required.
5.14.c.2. Water Supply. Distance from a drinking water supply shall comply with paragraph 5.14.a.3. of this rule.
5.14.c.3. Geology and Soils. These shall comply with paragraph 5.14.a.4. of this rule.
5.14.c.4. Shape. The shape shall comply with paragraph 5.14.a.5. of this rule.
5.14.c.5. Design.
5.14.c.5.A. Method. The design of aeration basins is normally based upon the aerated lagoon theory using a Ke of 0.5 (at 20 degrees C). Formulas to be used are: t = % removal/ (100-% removed) KT = days detention where: KT = 0.5 (1.075)T-20 T = average year-round air temperature at the site in degrees C.
The dissolved oxygen level should be a minimum of 2 ppm and assumed that ratio of oxygen transfer should be at (0.9). The oxygen requirement should be based upon the removal of 1.5 pounds/pound of BOD5.
5.14.c.5.B. Depth. The aeration basin shall be of a depth ranging from six to 15 feet. Supplying air to the aeration basin shall be by means of surface aerators or subsurface air diffusers. A 96-pin time clock shall operate each surface aerator. The design of basins shall be to distribute oxygen throughout, but not to keep solids in suspension.
5.14.c.5.C. Settling. A settling pond shall follow the aeration basin. The size of the settling pond shall be based upon BOD5 remaining after aeration at the loading rate of 34 pounds of BOD5 per surface acre per day.
5.14.c.6. Lagoon Details. Lagoon shape, dikes, embankments, construction, and effluent lines shall comply with paragraph 5.14.b.6. of this rule.
5.15. Disinfection.
5.15.a. General. There shall be adequate disinfection of all sewage treatment plant effluents prior to discharge. All wastewater treatment works using gas chlorination shall have a Chlorine Institute chlorine repair kit.
5.15.b. Chlorination.
5.15.b.1. Chlorine Terminology. The word "chlorine" whenever used in this section refers to dry chlorine unless otherwise indicated.
5.15.c. Equipment.
5.15.c.1. Feed Equipment Type. This rule generally prefers solution-feed vacuum-type chlorinators for plants greater than 100,000 gallons per day in size. There shall be consideration given to the use of hypochlorite solution feeders of the positive displacement type. For plants of 100,000 gallons per day or less in size, using tablet type chlorinators shall receive approval.
5.15.c.2. Feed Equipment Capacity. Chlorinator capacities required may vary, depending on the use and point of application of the chlorine. For disinfection, the capacity shall be such to produce a residual of 0.5 ppm maximum in the final effluent at peak flow rates.
5.15.c.3. Chlorination Equipment and Spare Parts. It is a requirement to maintain an inventory of parts subject to wear and breakage at all times. This rule requires dual chlorinators for plants over 100,000 gallons per day in size. Each chlorinator shall be able to provide the required chlorination at peak flow rates. If the discharge is within a five-mile distance up-stream from a public water supply, chlorination of the sewage effluent shall be a requirement unless a written waiver is granted by the Commissioner.
5.15.c.3.A. Water Supply. A supply of water shall be available for operating the chlorinators. When a booster pump is required, there shall be duplicate pumping equipment. When a connection is made from the domestic water supplies, there shall be a provision for equipment for backflow prevention. There shall be pressure gauges on chlorinator water supply lines.
5.15.c.3.B. Measurement Equipment. There shall be equipment for measuring the amount of chlorine use.
5.15.c.4. Evaporators. When manifolding of several cylinders is required to feed sufficient chlorine, there shall be consideration given to the installation of evaporators.
5.15.c.5. Leak Detection and Controls. A bottle of ammonium hydroxide solution shall be available for detecting chlorine leaks. Also, there shall be consideration given to the provision of caustic soda solution reaction tanks for absorbing the contents of leaking one-ton cylinders where the cylinders are in use. There shall be installation of automatic leak detectors wherever using gas chlorination.
5.15.d. Piping and Connections.
5.16.d.1. General. Piping systems shall be well supported, adequately sloped to allow drainage and protection from mechanical damage. Due to changes in temperature, there shall be allowance for pipe expansion.
5.15.d.2. Condensation. When a vaporizer does not provide adequate superheat, a pressure reducing valve shall be used to prevent condensation.
5.15.d.3. The arrangement of chlorine solution piping shall be such that any or all chlorinators may pre-chlorinate and post-chlorinate.
5.15.e. Housing.
5.15.e.1. Building. The design and construction of any building to house chlorine equipment or containers shall be to protect all elements of the chlorine system from fire hazards. If storing or processing flammable materials in the same building with chlorination equipment other than that using hypochlorite solutions, there shall be a fire wall erected to separate the two areas.
5.15.e.1.A. If gas chlorination equipment and chlorine cylinders are to be in a building used for other purposes, a gas-tight partition shall separate this room from any other portion of the building. Doors to this room shall equip panic hardware and applicant shall install a chlorine detector/alert system. The rooms shall be at ground level and shall permit easy access to all equipment. Storage area shall be separated from the feed area. This rule does not permit a basement.
5.15.e.1.B. There shall be a means of exit to the outside of the building from each separate room or building in which applicant is storing, handling, or using chlorine, other than hypochlorite.
5.15.e.1.C. There shall be installation of a clear glass, gas-tight window in an exterior door or interior wall of the chlorinator room to permit viewing of the chlorinator without entering the room.
5.15.e.2. Heat. There shall be chlorinator rooms with a means of heating and maintaining a temperature of at least 60 degrees Fahrenheit. The room shall also have protection from excess heat.
5.15.e.3. Ventilation. There shall be installation of forced, mechanical ventilation that provides one complete air change per minute in all chlorine feed rooms and rooms where storing chlorine cylinders. The entrance to the air exhaust duct from the room shall be near the floor and the location of the point of discharge shall be so as not to contaminate the air inlets to any building or inhabited areas. The location of air inlets shall be so as to provide cross ventilation with air and at such a temperature that shall not adversely affect the chlorination equipment. The vent hose shall run without traps from the chlorinator and shall discharge to the outside atmosphere above grade.
5.15.e.4. Electrical Controls. The controls for the fans and lights shall be such that they shall automatically operate when the door is opened and manually operated from the outside without opening the door.
5.15.e.5. Respiratory Protection. Respiratory air-pac protection equipment, meeting the requirements of the National Institute for Occupational Safety and Health (NIOSH), shall be available where the handling of chlorine gas takes place, and stored at a convenient location, but not inside any room when using or storing chlorine. There shall be instructions posted for using the equipment. The units shall use compressed air, have at least a 30-minute capacity, and be compatible with the units used by the fire department responsible for the plant. This rule requires a minimum of two air-pacs.
5.15.f. Application of Chlorine.
5.15.f.1. Mixing with Flow. There shall be provisions to ensure uniform mixing of the chlorine solution with the wastewater flow near the point of application.
5.15.f.2. Contact Period. There shall be a minimum contact period of 40 minutes at average daily flow or 15 minutes at maximum daily flow. Additional contact time may be a requirement if the discharge point is in proximity to a water supply intake, recreational area, or some other similar area.
5.15.f.3. Contact Tank. Design of chlorine contact tanks shall be to minimize "short-circuiting" of flow. There shall be over and under, or end-around, baffling provided. This rule requires air lift sludge returns from the contact tank for all extended aeration sewage treatment plants unless preceded by a filter or polishing pond. This rule requires multiple units for plants over 100,000 gallons in size.
5.15.g. De-chlorination. The removal of all or part of the chlorine residual may be a requirement prior to final discharge, to meet the adopted stream standards or other requirements for particular streams.
5.15.g.1. Other Methods. The Commissioner shall evaluate the use of other methods for disinfection on a case-by-case basis. As a minimum, there shall be an investigation when intending to use other disinfection methods.
5.15.g.2. Minimum effluent conditions, such as clarity, soluble organics and pH are required for adequate disinfection.
5.15.g.3. Methods for dispersion and mixing with the waste stream are required.
5.15.g.4. Other factors, including but not limited to, equipment reliability, safety and application rates are required for varying waste flows.
5.15.g.5. Refer to paragraph 5.1.c.3. of this rule.
5.15.h. Evaluation of Effectiveness.
5.15.h.1. Sampling. There shall be facilities included for securing a sample prior to discharge to determine the effectiveness of the disinfection method.
5.15.h.2. Residual Chlorine Testing and Control. When using chlorine for disinfection, there shall be equipment for measuring chlorine residual. When the discharge occurs in critical areas, the installation of facilities for continuous automatic chlorine residual analysis, recording and proportioning systems may be a requirement.
5.16. Supplementary Treatment.
5.16.a. General. Supplementary treatment shall be a requirement when health considerations or waste load allocations and effluent limitations require treatment more stringent than secondary.
5.16.b. Alternating Surface Sand Filters.
5.16.b.1. General. Normally, an applicant shall use alternating surface sand filters for plants of 100,000 gallons per day or less in size. The commissioner may permit alternating surface sand filters for plants of over 100,000 gallons per day in size on a case-by-case basis. No individual surface sand filter shall exceed 500 square feet.
5.16.b.2. Filter Rate. The design of an alternating sand filter shall be for a filter rate of not more than 20 gallons per square foot per day.
5.16.b.3. Application. The effluent application shall be with either a pump or siphon chamber designed to dose all sections of the filter equally with three to four inches of liquid in 20 minutes or, where elevation differences permit, the Commissioner may permit gravity application of effluent to the filter if the distribution of the effluent is uniform.
5.16.b.4. Location. The location of alternating surface sand filters shall not be within 100 feet of the nearest occupied residence or habitation. The commissioner may waive this distance requirement in the event applicant obtains a release from the neighboring property owner or owners.
5.16.b.5. Media. The sand used in alternating surface sand filters shall be coarse, clean sand of uniform size. Effective size of 0.5 to 1.5 mm in diameter with a uniformity coefficient of no greater than 3.0 and less than 1% fines passing a 100 sieve. The Commissioner may waive this requirement if finding the media is to perform in an adequate manner.
5.16.b.6. Construction. The side walls, dividing partitions and bottom of the sand filters shall be impermeable. General construction shall be as shown in the Portfolio of Drawings.
5.16.b.7. Disinfection. This rule requires disinfection after the filters and before discharge to a stream.
5.16.c. High-Rate Effluent Filtration.
5.16.c.1. General. High-rate filters may be either gravity or pressure.
5.16.c.1.A. Pressure. This rule limits the use of pressure high-rate filters to plants of greater than 100,000 gallons per day in size.
5.16.c.2. Filtration Rates. Allowable rates for gravity filters shall not be greater than one gallon per minute per square foot per day. Filtration rates for pressure filters shall not be greater than five gallons per minute per square foot per day. Rates are based upon the maximum flow rate applied.
5.16.c.3. Number of Units. There shall be total filter area in two or more units, and calculation of the filtration rate shall be on the total available filter area with one unit out of service, for plants of 40,001 gallons per day or more in size.
5.16.c.4. Backwash. Backwash shall include either or both air scouring and positive surface wash. There shall be a provision for using filtered effluent for backwash and waste filter backwash water. It shall return to the head of the plant.
5.16.c.4.A. Backwash Water Storage. Total backwash water storage capacity required shall equal or exceed one complete backwash cycle.
5.16.c.4.B. Backwash Rate. The backwash rate shall not exceed 20 gallons per minute per square foot with a minimum backwash period of 10 minutes.
5.16.c.4.C. Pumps. An applicant shall size and interconnect pumps for backwashing filter units to provide the required rate to any filter with the largest pump out of service.
5.16.c.5. Proprietary Equipment. Where proposing proprietary filtration equipment not conforming to the preceding requirements, an applicant shall provide data that supports the capability of the equipment to meet effluent requirements under design conditions. The Commissioner shall consider the equipment on a case-by-case basis.
5.16.c.6. Equipment Serving Plants with Design Flows of 40,000 Gallons Per Day or Less. When proposing filtration equipment serving plants with design flows of 40,000 gallons per day or less not conforming to the preceding requirements, an applicant shall provide data that supports the capability of the equipment to meet effluent requirements under design conditions. The Commissioner shall consider the equipment on a case-by-case basis.
5.16.d. TKN Removal.
5.16.d.1. General. Consideration shall be given to TKN removal when the total Kjeldahl nitrogen limit as stated in the discharge load allocation is less than 18 mg/l.
5.16.d.2. Methods. Methods used to achieve TKN removal may include, but not be limited to: additional aeration in extended aeration plants; separate stage nitrification; break-point chlorination; nitrification column; and alternating surface sand filters.
5.16.e. Microscreening.
5.16.e.1. General. An applicant may use microscreening units following a biological treatment process for the removal of residual suspended solids.
5.16.e.2. Materials. Microscreen shall be either a specially woven polyester or stainless steel with aperture size of 20 to 30 microns.
5.16.e.3. Design. The hydraulic loading shall not be greater than 10 gallons per minute per square foot of submerged drum surface. Maximum head loss shall be 12 to 18 inches. There shall be an overflow weir to bypass part of the flow when head exceeds six to eight inches. It is recommended that drums be not less than 10 feet in diameter.
5.16.e.4. Backwash. Application of continuous pressurized (60 psig) backwash shall be at a minimum rate of eight gallons per minute per square foot of screen. There shall be dual backwash pumps, with each pump being capable of supplying 100% of the required flow. Backwash water shall return to the head of the plant at a rate not to exceed 15% of the average daily design flow.
5.16.e.5. Reliability. There shall be dual microscreen units with each unit being capable of providing 100% of the design microscreen capacity. There shall be automatic drum speed controls with provision for manual override for each screen. It is a requirement to enclose all units in a heated and ventilated structure.
5.16.f. Polishing Ponds.
5.16.f.1. General. The design of polishing ponds shall be in accordance with Section 5.14.b. of this rule. Polishing ponds shall have a capacity of at least 65,000 gallons or capacity for a detention time of 10 days plant design flow, whichever is greater.
5.16.f.2. Distance Requirements. The location of polishing ponds shall be at least 100 feet from the nearest occupied structure.
5.16.g. Post Aeration. Meeting a discharge load allocation of 6.0 milligrams per liter dissolved oxygen shall be by means of one of the following:
5.16.g.1. Post aeration tank with air added by diffusion or mechanical means;
5.16.g.2. Cascade aeration; or
5.16.g.3. Polishing ponds shall provide the dissolved oxygen requirements.
5.17. Sludge Handling and Disposal.
5.17.a. Anaerobic Sludge Digestion.
5.17.a.1. Multiple Units. This rule recommends multiple tanks. When using a single digestion tank, there shall be an alternate method of sludge processing or emergency storage to maintain continuity of service.
5.17.a.2. Depth. For those units proposed to serve as supernatant separation tanks, the depth shall be sufficient to allow for the formation of a reasonable depth of supernatant liquor. This rule recommends a minimum sidewater depth of 10 feet.
5.17.a.3. Maintenance Provisions. To facilitate draining, cleaning, and maintenance, the following features are desirable:
5.17.a.3.A. Slope. The tank bottom should slope to drain toward the withdrawal pipe. For tanks equipped with a suction mechanism for withdrawal of sludge, this rule recommends a bottom slope not less than 1:12. When the sludge removal is to be by gravity alone, this rule recommends 1:4 slope.
5.17.a.3.B. Access Manholes. In addition to the gas dome, there shall be at least two 36-inch diameter access manholes in the top of the tank. There shall be stairways to reach the access manholes. There shall be a separate sidewall manhole. The opening should be large enough to permit the use of mechanical equipment to remove grit and sand.
5.17.a.3.C. Safety. There shall be non-sparking tools, safety lights, rubber-soled shoes, safety harness, gas detectors for inflammable and toxic gases and at least two self-contained breathing units for emergency use.
5.17.a.4. Sludge Inlets and Outlets.
5.17.a.4.A. Recirculation. There shall be multiple recirculation withdrawal and return points, unless incorporating mixing facilities within the digester. The return shall discharge above the liquid level and the location shall be near the center of the tank.
5.17.a.4.B. Raw Sludge Discharge. Raw sludge discharge to the digester shall be through the sludge heater and recirculation return piping, or directly to the tank if there are internal mixing facilities.
5.17.a.4.C. Withdrawal. Sludge withdrawal to disposal shall be from the bottom of the tank. This pipe shall interconnect with the recirculation piping.
5.17.a.5. Tank Capacity. The determination of the total digestion tank capacity shall be by rational calculations based upon such factors as volume of sludge added, its percent solids and character, the temperature to maintain in the digesters, the degree or extent of mixing to obtain and the degree of volatile solids reduction required. An applicant shall submit calculations to the Commissioner, to justify the basis of design. When the calculations are not based on the above factors, the minimum combined digestion tank capacity design shall be based on: the assumption that a raw sludge evolves from ordinary domestic wastewater, that a maintained digestion temperature is to be in the range of 90 degrees Fahrenheit to 100 degrees Fahrenheit or (32 degrees Celsius and 38 degrees Celsius), that the digested sludge shall maintain 40% to 50% volatile matter, and that there shall be frequent removal of the digested sludge from the system.
5.17.a.5.A. Completely-Mixed Systems. Completely-mixed systems shall provide for effective mixing. Loading the system may be at a rate up to 80 pounds of volatile solids per 1,000 cubic feet of volume per day in the active digestion units. When there are no grit removal facilities, reducing the digester volume due to grit accumulation shall be considered.
5.17.a.5.B. Moderately-Mixed Systems. For digestion systems where accomplishing mixing is only by circulating sludge through an external heat exchanger, loading the system may be at a rate up to 40 pounds of volatile solids per 1,000 cubic feet of volume per day in the active digestion units. Modification to this loading may be upward or downward depending upon the degree of mixing provided.
5.17.a.6. Gas Collection, Piping, and Appurtenances.
5.17.a.6.A. General. The design of all portions of the gas system, including the space above the tank liquor, the storage facilities, and the piping, shall be so that under all normal operating conditions, including sludge withdrawal, the gas shall be maintained under positive pressure. All enclosed areas where any gas leakage might occur shall have adequate ventilation.
5.17.a.6.B. Safety. When producing gas all safety facilities shall be used. There shall be pressure and vacuum relief valves and flame traps, along with automatic safety shutoff valves. This rule does not permit water seal equipment. Housing gas safety equipment and gas compressors shall be in a separate room with an exterior entrance.
5.17.a.6.C. Gas Piping and Condensate. Gas piping shall be of adequate diameter and shall slope to condensate traps at low points. This rule does not permit the use of float-controlled condensate traps.
5.17.a.6.D. Gas Utilization Equipment. The location of gas-fired boilers for heating digesters shall be in a separate room not connected to the digester gallery.
5.17.a.6.E. Electrical Fixtures. Electrical fixtures and controls in places enclosing anaerobic digestion appurtenances, when the tanks and piping normally contain hazardous gases, shall comply with the National Electrical Code for Class 1, Group D, Division 2 locations. An applicant shall isolate digester galleries from normal operating areas to avoid an extension of the hazardous location.
5.17.a.6.F. Waste Gas. Waste gas burners shall be readily accessible and located at least 25 feet away from any plant structure if placed at ground level or located on the roof of the control building if sufficiently removed from the tank. All waste gas burners shall equip an automatic ignition, such as a pilot light or a device using a photoelectrical cell sensor. The use of natural or propane gas to ensure reliability of the pilot light shall be considered. Discharging the gas to the atmosphere through a return-bend screened vent terminating at least 10 feet above the ground surface, provided that the assembly incorporates a flame trap, may be permissible in remote locations.
5.17.a.6.G. Ventilation. Any underground enclosures connecting with digestion tanks, or containing sludge, gas piping or equipment shall be equipped with forced ventilation. The piping gallery for digesters shall not connect to other passages. If self-closing doors are used at connecting passageways and tunnels to minimize the spread of gas, they shall be tightly fitting.
5.17.a.6.H. Meter. There shall be a gas meter with a bypass to meter total gas production.
5.17.a.7. Digester Heating.
5.17.a.7.A. Insulation. Wherever possible, the construction of tanks shall be above ground water level and suitably insulated to minimize heat loss.
5.17.a.7.B. Heating Facilities. Sludge may be heated by circulating it through external heaters or using heating units located inside the digestion tank.
5.17.a.7.B.1. The design of piping for external heating shall be to provide for the preheating of feed sludge before introduction to the digesters. There shall be provisions in the layout of the piping and valving to facilitate cleaning of these lines. The sizing of heat exchanger sludge piping should be for heat transfer requirements.
5.17.a.7.B.2. Other Heating Methods. The Commissioner shall consider other types of heating facilities on their own merits.
5.17.a.7.C. Heating Capacity. There shall be heating capacity sufficient to consistently maintain the design sludge temperature. When using a digester tank gas for sludge heating, an auxiliary fuel supply is required.
5.17.a.7.D. Hot Water Internal Heating Controls.
5.17.a.7.D.1. There shall be an automatic mixing valve to temper the boiler water with return water so that the inlet water to the heat jacket can be held below a temperature at which caking shall be accentuated. In addition, there shall be manual control provided by bypass valves.
5.17.a.7.D.2. The boiler shall equip automatic controls to maintain the boiler temperature at approximately 180 degrees Fahrenheit to shut off the main gas supply in the event of pilot burner or electrical failure, low boiler water level, or excessive temperature.
5.17.a.7.D.3. There shall be thermometers to show temperatures of the sludge, hot water feed, hot water return, and boiler water.
5.17.a.8. Supernatant Withdrawal.
5.17.a.8.A. Piping Size. Supernatant piping shall not be less than six inches in diameter.
5.17.a.8.B. Withdrawal.
5.17.a.8.B.1. Arrangement of piping shall be so that withdrawal can be made from three or more levels in the digester. There shall be a positive unvalved vented overflow.
5.17.a.8.B.2. If providing a supernatant selector, provisions shall be made for at least one other drawoff level located in the supernatant zone of the tank in addition to the unvalved emergency supernatant drawoff pipe. There shall be high pressure backwash facilities.
5.17.a.8.C. Sampling. There shall be provisions for sampling at each supernatant drawoff level. Sampling pipes shall be at least 1.5 inches in diameter and shall terminate at a suitably-sized sampling sink or basin.
5.17.a.8.D. Alternate Supernatant Disposal. An applicant shall give consideration to supernatant conditioning, when appropriate, in relation to its effect on plant performance and effluent quality.
5.17.b. Aerobic Sludge Digestion.
5.17.b.1. General. Using aerobic digestion may stabilize secondary sludge. There shall be digestion in single or multiple tanks, designed to provide effective air mixing, reduction of the organic matter, supernatant separation, and sludge concentration under controlled conditions.
5.17.b.2. Digestion Tanks. This rule recommends multiple tanks. An applicant may use a single sludge digestion tank in the cases of small treatment plants, when making provisions for sludge handling, or when a single unit shall not adversely affect normal plant operations.
5.17.b.3. Mixing and Air Requirements. Design of aerobic sludge digestion tanks shall be for effective mixing by aeration equipment. There shall be sufficient air to keep the solids in suspension and maintain dissolved oxygen between one and two milligrams per liter. There shall be a minimum mixing and oxygen requirement of 30 cfm per 1,000 cubic feet of tank volume with the largest blower out of service. If using diffusers, the non-clog type is a requirement, and their design shall be to permit continuity of service. If using mechanical aerators, there shall be a minimum of 1.0 horsepower per 1,000 cubic feet. This rule discourages the use of mechanical equipment in areas where freezing temperatures are typical.
5.17.b.4. Tank Capacity. The determination of tank capacities shall be based on rational calculations, including such factors as quantity of sludge produced, sludge characteristics, time of aeration, and sludge temperature.
5.17.b.4.A. Volatile Solids Loading. The volatile suspended solids loading shall not exceed 100 pounds per 1,000 cubic feet of volume per day in the digestion units. Lower loading rates may be necessary depending on temperature, type of sludge, and other factors.
5.17.b.4.B. Solids Retention Time. Required minimum solids retention time for stabilization of biological sludges varies depending on type of sludge. Normally, there shall be a minimum of 15 days retention for waste activated sludge and 20 days for combination of primary and waste activated sludge, or primary sludge alone. In areas where sludge temperature is lower than 50 degrees Fahrenheit, additional detention time shall be considered.
5.17.b.5. Supernatant Separation. There shall be facilities for separation and withdrawal of supernatant and for collection and removal of scum and grease.
5.17.b.6. Sludge Thickening. Prior to placement on sludge drying beds, all sludge produced by the activated sludge process shall condition to a minimum solids content of 2% by weight.
5.17.c. Sludge Pumps and Piping.
5.17.c.1. Sludge Pumps.
5.17.c.1.A. Duplicate Units. There shall be duplicate units.
5.17.c.1.B. Type. There shall be plunger pumps, screw feed pumps, recessed impeller type centrifugal pumps, progressive cavity pumps, or other types of pumps capable of solids handling for handling raw sludge.
5.17.c.1.C. Minimum Head. There shall be a minimum positive head of 24 inches at the suction side of centrifugal-type pumps and that minimum is desirable for all types of sludge pumps. Maximum suction lifts shall not exceed 10 feet for plunger pumps.
5.17.c.1.D. Sampling Facilities. Unless sludge sampling valves are installed at the sludge pumps, the size of valve and piping shall be at least 1.5 inches.
5.17.c.2. Sludge Piping.
5.17.c.2.A. Size and Head. Sludge withdrawal piping shall have a minimum diameter of six 6 inches for gravity withdrawal and three inches for pump suction and discharge lines. When withdrawal is by gravity, the available head on the discharge pipe shall be adequate to provide at least 3.0 feet per second velocity.
5.17.c.2.B. Slope. Gravity piping shall be laid on uniform grade and alignment. The slope of gravity discharge piping shall not be less than 3%. There shall be provisions for cleaning, draining and flushing discharge lines.
5.17.c.2.C. Supports. The corrosion resistance and continuing stability of supporting systems located inside the digestion tank shall receive special consideration.
5.17.d. Sludge Dewatering.
5.17.d.1. Sludge Drying Beds. Estimating the sizing of the drying bed shall be on the basis of four-square foot capita when the drying bed is the primary method of dewatering, and one square foot capita if using it as a back-up dewatering unit. Under no circumstances shall surface water enter the bed areas.
5.17.d.2. Design.
5.17.d.2.A. Gravel. An applicant shall grade the lower course of gravel around the underdrains, and it shall be 12 inches in depth, extending at least six inches above the top of the underdrains. It is desirable to place this in two or more layers. The top layer of at least three inches shall consist of gravel one eighth 0.125 inch to 0.25 inch in size.
5.17.d.2.B. Sand. The top course shall consist of six to nine inches of clean washed coarse sand with an effective size of 0.3 to 0.6 mm in diameter with a uniformity coefficient of no greater than 4.0 and less than 1% fines passing number 100 sieve. The Commissioner may waive this requirement if this media performs adequately. The finished sand surface shall be level.
5.17.d.2.C. Underdrains. Underdrains shall be at least four inches in diameter and the spacing of them shall be not more than 20 feet apart.
5.17.d.2.D. Partially Paved Type. The design of the partially paved drying bed shall be with consideration for space requirement to operate mechanical equipment for removing the dried sludge.
5.17.d.2.E. Walls. Walls shall be watertight and extend 15 to 18 inches above and at least six inches below the surface. There shall be curbing of outer walls to prevent soil from washing onto the beds.
5.17.d.2.F. Sludge Removal. There shall be not less than two beds and their arrangement shall be to facilitate sludge removal. There shall be concrete truck tracks for all percolation-type sludge beds.
5.17.d.2.G. Sludge Influent. The sludge pipe to the drying beds shall terminate at least 12 inches above the surface and be arranged so that it shall drain. There shall be concrete splash plates for percolation-type beds at sludge discharge points.
5.17.d.2.H. Protective Enclosure. A protective enclosure shall be considered if winter operation is required.
5.17.d.3. Mechanical Dewatering Facilities. There shall be a provision to maintain continuity of service so that an applicant may dewater sludge without accumulation beyond storage capacity. The number of vacuum filters, vacuum beds, centrifuges, filter presses, belt filters, and other mechanical dewatering facilities shall be sufficient to dewater the sludge produced with the largest unit out of service. Unless other standby facilities are available, there shall be adequate storage facilities. The storage capacity shall be sufficient to handle at least a three-month sludge production.
5.17.d.3.A. Auxiliary Facilities for Vacuum Filters. There shall be back-up vacuum pumps and filtrate pumps. It is permissible to have an uninstalled back-up vacuum pump or filtrate pump for every three or less vacuum filters, provided that the removal or replacement of the installed unit requires little effort.
5.17.d.3.B. Ventilation. There shall be facilities for ventilation of dewatering area. The condition of the exhaust air shall be to avoid odor nuisance.
5.17.d.3.C. Chemical Handling Enclosures. There shall be lime-mixing facilities of lime dust.
5.17.d.4. Drainage and Filtrate Disposal. Drainage from beds or filtrate from dewatering units shall return to the sewage treatment process at appropriate points.
5.17.d.5. Other Dewatering Facilities. If proposing to dewater or dispose of sludge by other methods, a detailed description of the process and design data shall accompany the plans.
5.18. Sewage Sludge, Disposal Methods. When considering sewage sludge disposal methods, such as incineration and landfill, an applicant shall follow appropriate requirements of the solid waste regulations.
5.19. Land Application of Sewage Effluent.
5.19.a. General. Land application shall not be considered as a treatment process, but only a means of disposing of sewage effluent that received secondary treatment. For public health reasons, this rule shall not permit land disposal of effluent that received primary treatment.
5.19.b. Preliminary Considerations.
5.19.b.1. Land application installations are normally used where the waste contains pollutants that can successfully be removed through distribution to the soil mantle. Removal of these pollutants may be through organic decomposition in the vegetation-soil complex and by absorptive, physical, and chemical reactions with earth materials. Preliminary considerations of a site for land application shall be the compatibility of the waste with the organic and earth materials and the percolation rates and exchange capacity of the soils. The land application of wastewater shall eventually recharge the local groundwater. Therefore, the quality, direction and rate of movement, and local use of the groundwater, present and potential, are prime considerations in evaluating a proposed site.
5.19.b.2. It is essential to maintain an aerated zone of at least five feet and preferably more, to provide good vegetation growth conditions and removal of nutrients. A groundwater mound shall develop below a disposal site after it is in use. The major factors in design of ground disposal fields are topography, soils, geology, hydrology, weather, agriculture practice, adjacent land use and equipment selection and installation.
5.19.c. Site Plan and Report. The following shall be considerations and included in a site plan and report:
5.19.c.1. Location Maps. USGS topographic map of the area, a 7.5-minute series where published, showing the location of the total property and proposed land application site; and West Virginia Division of Highways County Maps showing location of the total property.
5.19.c.2. Plan. A topographic map of the entire property at a workable scale showing all buildings, land application area, area of possible expansion, roads, direction of groundwater flow, active and abandoned wells, public water supplies, groundwater monitoring wells, streams, wooded areas, fences or other barriers, visible geologic formations such as sinkholes and rock outcrops, ponds, and all structures, wells, and ponds on adjacent property within 2,000 feet of the boundaries of proposed disposal area.
5.19.c.3. Soil Map. A soil map shall be furnished showing soil types within the land application site. An applicant may incorporate this information on the plan.
5.19.c.4. Report.
5.19.c.4.A. Geology of Site. This includes formations, rock types, degree of weathering of bedrock, local bedrock structure, character and thickness of surficial deposits, solution openings and sinkholes or limestone areas.
5.19.c.4.B. Hydrology of Site. This means the depth to seasonal high-water table and test well data including chemical and bacterial analysis for groundwater quality and depth of well.
5.19.c.4.C. Soils at Site. Cation exchange capacity of the soils, soil types and characteristics, detailed chemical analysis of the soils and thickness of the soils.
5.19.c.4.D. Climatological Data at Site. This includes daily rainfall and daily temperature.
5.19.c.4.E. Agricultural Practices at Site. This includes the present and intended soil-crop management practices, kinds of crops to be grown, harvesting frequency and ultimate use of crop.
5.19.c.4.F. Effluent Characteristics. This is the detailed chemical analysis of effluent to dispose.
5.19.c.4.G. Rate and Frequency of Application. This includes all calculations relating to nitrogen, cadmium and heavy metals and calculations for winter storage.
5.19.c.4.H. Management Practices. These include types of equipment for transport and application; supervision of site; contracts, land easements, land leases, land purchases, monitoring procedures, and emergency procedures in the event of plant or equipment breakdown.
5.19.d. Design.
5.19.d.1. Effluent Requirements. Secondary treatment shall be a requirement (30 mg/1 of BOD5 and 30 mg/1 of suspended solids). Disinfection shall be a requirement with disinfection occurring after secondary treatment.
5.19.d.2. Holding Pond. There shall be a minimum 90-day storage to store all flow during periods when disposal cannot occur. All storage shall be above a fixed water level to prevent complete draining of the pond. A two-foot residual water depth is a requirement to prevent growth of vegetation.
5.19.d.3. Application Rates. The maximum application rates in terms of depth of effluent are: 0.25 inch per hour; 0.5 inch per day; 2 inches per week. The above are maximum rates and lower application rates may be necessary in some areas due to soil characteristics.
5.19.d.4. Slopes. There shall be a limit on cultivated fields to 4% or less. The limit of slope on sodded fields shall be to 8% or less. The limit on forested slopes shall be 8% for year-round operation but for seasonal operation 14% slopes may be acceptable.
5.19.d.5. Runoff. The design of the system shall be to prevent surface runoff from entering or leaving the project site.
5.19.d.6. Fencing. A fence at least six feet high or a locked entrance gate shall enclose the irrigated area to keep out children and domestic animals.
5.19.d.7. Warning Signs. Appropriate signs shall be posted along the fence around the project boundaries to designate the nature of the facility and advise against trespassing.
5.19.e. Spray Irrigation.
5.19.e.1. Piping to Sprinklers. The arrangement of the piping shall be to allow the irrigation pattern to be varied easily. For a permanent system, facilities shall be designed to allow complete drainage of the pipes to prevent pollution and freezing, and to provide an even distribution over the entire field.
5.19.e.2. Pump Station. There shall be duplicate pumps for delivery to the spray field, with the capacity of each pump sized to handle maximum rate of flow, plus an allowance to deplete stored volumes. The pump station shall have a metering device that shall show the total flow and rates to the irrigation field. The top of the disinfection facility and the wet well of the pumping station shall be at least as high as the maximum holding pond surface elevation, to prevent flooding of the units when the spray irrigation equipment is not in operation. A control valve between the holding pond and the spray irrigation pump station is required.
5.19.e.3. Buffer Zone. Sprinklers shall be located to give a non-irrigated buffer zone around the irrigated area, and the design of the buffer zone shall consider wind transport of the wastewaters. A fence shall be placed at least 50 feet beyond the normal projected spray area. A minimum of 350 feet from the fence of the enclosed irrigated area to the property lines of adjacent areas or highways is required, unless there are:
5.19.e.3.A. Low sprays to reduce wind transport of the effluent; or
5.19.e.3.B. Physical buffers, such as trees, along with low sprays.
5.19.f. Ridge and Furrow.
5.19.f.1. Slopes. The construction of furrows may be down slope on sites up to 1%. The construction of furrows shall be at right angles to the slope on sites up to 8%.
5.19.f.2. Construction. Furrows shall be no more than 1,000 feet in length and spaced from 20 to 40 inches apart.
5.19.g. Overland Flow.
5.19.g.1. Slopes. Slopes shall range from 2% to 8%. Lengths of slopes shall range from 150 to 300 feet.
5.19.g.2. Construction. Slopes may be flooded, or application made by gated pipe or spray.
5.19.h. Monitoring and Reporting. A minimum of one drilled groundwater monitoring well shall be in each dominant direction of groundwater movement, and between the project site and public well(s) or high-capacity private wells, there shall be a provision for sampling at the surface of the water table and at five feet below the water table at each monitoring site. The Commissioner shall approve the location and construction of the monitoring well(s) before construction. These may include one or more of the test wells where appropriate. If crops are used for animal or human consumption, analysis of the crop shall be required at harvest. The Commissioner shall determine frequency of reporting on a case-by-case basis, based on site characteristics.
W. Va. Code R. § 64-47-6 Individual Sewage Systems
6.1. General. The design standards apply to the site requirements, design, construction, and maintenance of individual sewage treatment systems including septic tank soil absorption systems with standard soil absorption fields; serial distribution soil absorption fields; soil absorption beds; shallow soil absorption fields; mound systems; home aeration units; effluent disposal ponds; composting toilets; grey water disposal systems; holding tanks; privies; recycle systems; and any other systems that provide waste treatment and disposal for individual dwellings and commercial establishments.
6.1.a. When applying for approval for systems using soil absorption or on-site effluent disposal, an applicant shall submit to the Commissioner one copy of the completed application, the design data sheet, and the plan.
6.1.b. When applying for approval for systems using other methods of effluent disposal, an applicant shall submit to the Commissioner four copies of the completed application, the design data sheet, and the plan.
6.2. General Site Requirements.
6.2.a. The location of an individual sewage system shall not be in a poorly drained or filled area, or in any area where seasonal flooding occurs, without the prior written approval of the Commissioner. There may be exceptions if the construction of the fill area has been in accordance with directions of the Commissioner, or if an applicant provided evidence to the Commissioner that the fill area is suitable and of acceptable composition.
6.2.b. No part of an individual sewage system location shall be within 10 feet of a building, foundation, or property line.
6.2.c. No part of an individual sewage system location shall be within 25 feet of a public water supply line, or within 10 feet of a private water supply line.
6.2.d. The Commissioner shall determine the distance between a septic tank, home aeration unit, vault privy, or other sewage tank, and a public water system well or water supply.
6.2.e. The location of a septic tank, home aeration unit, vault privy, or other sewage tank shall be at least 50 feet from a private water well or groundwater supply.
6.2.f. The location of absorption fields, serial distribution systems, absorption beds, mound systems, and other soil absorption systems shall comply with the distances contained in Table 64-47-K at the end of this rule.
6.2.g. Roof drains, foundation drains, sump pumps, surface drains, or similar drains shall not connect to an individual sewage system.
6.2.h. The location of a septic tank or other treatment unit or disposal field shall not be under area to be paved, parking lots, driving surfaces, or any type of structure.
6.2.i. There shall be a minimum of three feet between any portion of a standard soil absorption system and seasonal groundwater bedrock, and any other impermeable layer.
6.2.j. There shall be no standard septic tank soil absorption system installed in soils where percolation test results show an average percolation time of less than five minutes per inch.
6.3. Site Evaluation.
6.3.a. The evaluation of a site for the installation of a soil absorption system, including absorption fields, serial systems, absorption beds, and others, shall include but not be limited to, percolation test results and evaluation of soils in a six-foot excavation. Percolation tests shall be performed according to the following:
6.3.a.1. A minimum of four test holes shall be placed at equal distances over the entire absorption field site. If the results of the tests are reasonably close, it shall be considered an average test result. If the tests results show extreme variations, it may be considered necessary to relocate the field in a more suitable area;
6.3.a.2. Holes shall be bored to the depth of the proposed soil absorption field from six to eight inches in diameter at the site where the installation of the soil-absorption field is to take place;
6.3.a.3. The bottom and sides of the hole shall be scratched with a sharp pointed instrument or wire brush to remove any smeared soil surfaces that interfere with the absorption of water into the soil;
6.3.a.4. The loose dirt shall be removed from the bottom of the test holes and two inches of gravel shall be placed into the holes to prevent sealing;
6.3.a.5. A nail or a marked measuring device shall be placed in the wall of each hole exactly six inches above the level of the gravel;
6.3.a.6. The test hole shall be completely filled with water to ground level and maintained to a depth of at least 12 inches for a minimum period of four hours before beginning the percolation rate measurement.
6.3.b. Percolation Rate Measurement. After completing the requirements in paragraphs 6.3.a.1. through 6.3.a.6., the water depth shall be adjusted in the holes to the six- inch level. Determine how many minutes it takes for all of the water to absorb into the soil. The resulting time in minutes, divided by six, shall be the rate of fall or absorption per inch.
6.3.b.1. The average rate of fall for all test holes shall be determined by adding the rate of fall for each test hole together and dividing by the number of test holes. This figure is the average rate of fall per inch. See Table 64-47-L at the end of this rule.
6.3.b.2. If desired, an applicant may use an alternate test, if approved by the local health department.
6.3.b.3. Observation Hole. A hole shall be excavated six feet deep in the center of the proposed soil absorption system area to evaluate the soil depth to bedrock and the seasonal water table. If slopes at the proposed site exceed 15%, the excavated observation hole shall be placed at the location of the lowest proposed trench of the system. Additional observation holes may be required when there are extreme variations in soil or geology in the test area.
6.3.b.4. Six feet deep slit trenches of a specified length may be required in limestone geology to determine depth to bedrock.
6.4. Septic Tanks.
6.4.a. Liquid capacities for tanks serving single-family dwellings shall be in accordance with the following:
6.4.a.1. For four or fewer bedrooms, the minimum tank capacity shall be 1,000 gallons; and
6.4.a.2. For each additional bedroom, the minimum tank capacity shall be 250 gallons per bedroom.
6.4.b. When using a dual compartment tank or dual tanks, the volume ratio of the first compartment or tank to the second compartment or tank shall approximate 2-to-1. In a dual compartment tank, the connection between compartments shall be an elbow with a minimum diameter of four inches, placed so that the invert at the partition is approximately 16 inches below the liquid level.
6.4.c. The construction of septic tanks may be of reinforced concrete, fiberglass or other watertight and durable materials approved by the Commissioner. All tanks shall meet the general requirements of subdivision 6.4.g. of this rule, regardless of construction material. Septic tank construction shall comply with the following:
6.4.c.1. Precast Concrete Septic Tanks. Concrete used shall consist of at least six bags of cement per yard of concrete mix or the equivalent, with a minimum compressive strength of 4,000 pounds per square inch based on a 28-day compression test. Reinforcement shall be at least six inches by six inches mesh number 10 welded wire fabric or the equivalent. Aggregate used in the concrete shall be no larger than one inch in size. There shall be vibrated concrete to minimize honey-combing. The sidewalls of the tanks shall be at least 2.5 inches in thickness. The top and bottom shall have a minimum thickness of four inches.
6.4.d. The manufacturers of concrete septic tanks shall obtain approval from the Commissioner for the construction of and compliance with the Design Standards.
6.4.e. Metal Septic Tanks. Metal septic tanks shall not be approved due to their potential to leak into ground water.
6.4.f. Plastic and Fiberglass Tanks. The Commissioner shall approve plastic and fiberglass tanks.
6.4.g. General requirements for tanks shall be as follows:
6.4.g.1. The invert of the inlet pipe shall be a minimum of two inches above the invert of the outlet pipe.
6.4.g.2. Inlets and outlets shall be a minimum of four inches in diameter and equipped with a flexible watertight seal.
6.4.g.3. The inlet shall equip a cast-in-place or inserted baffle or a sanitary tee. The inlet baffle or sanitary tee shall extend to a minimum depth of six inches, but to no more than 20% of the liquid depth.
6.4.g.4. The outlet shall equip a cast-in-place or inserted baffle or sanitary tee. The effluent baffle shall extend to at least 35% of the liquid depth, but to no more than 40% of the liquid depth.
6.4.g.5. The top of the inlet and outlet baffles or tees shall extend at least six inches above the flow line.
6.4.g.6. Minimum liquid depth shall be 30 inches.
6.4.g.7. There shall be a minimum of nine inches clearance above the liquid level.
6.4.g.8. The top of the tank, above the outlet, shall have embossing, imprinting, stenciling or other form of marking in an indelible and legible manner with the manufacturer's name, the liquid capacity and date of manufacture.
6.4.g.9. Access. There shall be adequate access to each compartment of the tank for inspection and cleaning. Both the inlet and outlet devices shall be accessible. When installing a septic tank at a depth greater than 12 inches below grade, it shall be required to install an extended manhole riser to within 12 inches of final grade.
6.4.g.10. All septic tanks shall have a four-inch gas tight inspection port that extends to the surface of the ground to measure sludge and scum accumulations.
6.5. The Standard Soil Absorption System.
6.5.a. The pipe for gravity distribution systems shall have a minimum diameter of four inches. Pressure distribution systems may use smaller size pipe.
6.5.b. Pipe used in the construction of soil absorption fields shall conform to the ASTM Standards for wastewater piping. This includes, but is not limited to:
6.5.c. Plastic pipe ASTM - D 2729, D 2852, D 3350, D 2751, D 2836, D 3033, D 3034, D 3298, F 789.
6.5.d. The septic tank inlet and outlet piping shall be schedule 40 or the equivalent. This pipe shall span the tank hole excavation and rest on a minimum of two feet of undisturbed soil.
6.5.e. Perforated pipe used in the construction of soil absorption systems shall have a minimum of two rows of downward facing holes approximately 90 degrees apart.
6.5.f. Aggregate used in the construction of a soil absorption field shall be washed gravel, crushed stone, or slag, 0.5 to 2.5 inches in size, with a hardness of three on the Mohs scale of hardness. The field test for hardness is that the aggregate shall scratch a copper penny without leaving a residue.
6.5.g. The installation of gravel-less soil absorption systems shall be in accordance with manufacturers’ specifications as approved by the Commissioner.
6.5.h. The construction of the standard soil absorption field with either level or sloping topography shall be in accordance with the following specifications:
6.5.h.1. The trenches shall be one to three feet wide with a maximum depth of 36 inches and a minimum depth of 18 inches.
6.5.h.2. If distribution lines of greater than 100 feet are necessary, the connection of the inlet line shall be so that the lengths on either side of the connection shall not exceed 100 feet each. Absorption fields dosed by a pump or dosing siphon may utilize trenches of greater length, if reviewed and approved by the Commissioner.
6.5.h.3. There shall be a minimum of six inches of aggregate placed in the bottom of the trench beneath the pipe, and a minimum of two inches placed above the pipe.
6.5.h.4. The construction of the bottom of each trench and its distribution line shall be level. The construction of trenches shall be consistent with the topography and in such a manner so as to minimize the compaction or smearing of the sides and bottoms. Construction of the trenches shall not take place if the soil is so wet that it forms a "wire" instead of breaking apart when rolled between the hands. Construction shall not take place during rain or inclement weather that may interfere with or preclude correct construction procedures.
6.5.h.5. The surface of the aggregate shall have a cover of a minimum of three inches of straw or hay, or one layer of untreated building paper or filter fabric prior to backfilling.
6.5.h.6. There shall be a minimum of six feet of undisturbed earth between the sidewalls of each trench. Additional separation may be a requirement in areas of severe topography and poor soil characteristics to avoid interaction between the trenches.
6.5.h.7. The design of soil absorption fields constructed in flat areas shall be to provide a closed continuous system or closed-circuit design.
6.5.h.8. Performing the backfilling of the absorption field shall be in such a manner as to minimize compaction. There shall be a mound of backfill over the system to allow for settling and to promote run-off from the system. There shall be no grading to the absorption field construction area after backfilling. There shall be no backfilling if the ground is frozen.
6.5.h.9. The sewer line from the structure to the septic tank shall lay on a grade of not less than 0.125 of an inch per foot (1%).
6.5.h.10. The installation of the absorption field shall be so that the invert of the absorption field piping is a minimum of eight inches lower than the invert of the sewage tank outlet.
6.5.h.11. The construction of the standard soil absorption field in areas of sloping topography shall be in accordance with the following specifications:
6.5.h.11.A. Soil absorption fields constructed on sloping ground shall use a serial distribution system. This rule recommends the use of drop boxes;
6.5.h.11.B. The construction of soil absorption systems shall not be on ground with a slope in excess of 25%;
6.5.h.11.C. The bottom of each trench and its distribution line shall be level;
6.5.h.11.D. There shall be a minimum of six inches of ground cover over the gravel fill in each trench; and
6.5.h.11.E. The absorption trenches shall follow the approximate ground surface contours to minimize variation in trench depth.
6.5.h.12. Adjacent trenches shall connect with a relief line, cross over, or drop box arrangement in such a manner that each trench is completely filled with septic tank effluent to the full depth of the gravel before effluent flows to succeeding trenches. The construction of the relief line, cross-over, or drop box arrangement shall incorporate the following requirements:
6.5.h.12.A. The relief line or crossover shall be a solid four-inch sewer line with tight joints and with direct connection to the distribution lines or a drop box installation.
6.5.h.12.B. The construction of relief lines, cross-overs, and drop boxes shall not be in any location or manner where they shall be subject to damage during or following construction. An applicant shall mark the location of these relief lines, cross-overs, or drop boxes prior to backfilling to avoid damage from heavy equipment. The line shall rest on undisturbed earth with care given to carefully tamping the backfill.
6.5.h.12.C. The trench for the relief pipe or cross-over shall be no deeper than the top of the gravel of the trenches being connected. The line shall rest on undisturbed earth with care given to carefully tamping the backfill. An applicant shall exercise care in construction of the relief or cross-over line to ensure that an undisturbed block of earth remains between the trenches.
6.5.h.12.D. The invert of the overflow pipe in the first relief or cross-over line should be at least two inches lower than the invert of the septic tank outlet.
6.5.i. When servicing a structure other than a single-family dwelling, there shall be a reservation of land for the construction of two standard soil-absorptions fields, each of adequate size to serve the proposed structure.
6.5.j. If the soil absorption field is greater than 1,500 square feet in area, a siphon chamber or pump chamber may be required by the Commissioner to ensure even distribution of effluent.
6.5.k. Absorption fields over 3,000 square feet in total area shall include some form of dosing.
6.5.l. When a total field area over 5,000 square feet is necessary, the field shall be split into two or more fields of approximately equal size.
6.6. Absorption Beds.
6.6.a. The construction of absorption beds shall only be when topography or space limitations prevent installation of a standard absorption field.
6.6.b. The size of absorption beds shall be to provide an area 30% greater than that calculated for a standard absorption field to make up for sidewall loss.
6.6.c. The installation of the piping distribution network within the bed shall be in such a manner that the location of the pipes are 18 to 36 inches from the sides of the bed with a minimum of three feet between pipes and a maximum of six feet between pipes in a continuous or closed-circuit design. Construction of the bed shall be in accordance with the general design and construction requirements of the standard absorption field.
6.6.d. Maximum depth of an absorption bed shall be 36 inches, minimum depth shall be 18 inches.
6.7. Dual Soil Absorption Fields.
6.7.a. Use of dual absorption fields may receive approval if percolation rates are between 60 minutes and 90 minutes per inch.
6.7.b. Area reserved for absorption shall provide sufficient area for the replacement of dual soil absorption fields.
6.7.c. Construction of the dual absorption fields shall be in accordance with the dosing requirements of the standard soil absorption system, with a junction box or valving arrangement to provide for alternation of the fields. The size of each of the fields shall be in accordance with the percolation test results. Both fields shall be of the maximum sizing required for a 60 minutes per inch rate.
6.8. Shallow and Elevated Soil Absorption Systems.
6.8.a. Due to the shallowness of many West Virginia soils, a soil absorption system shall often have to be shallow, or the elevation shall be above the original ground surface to maintain the minimum distance above the seasonal high-water table, rock table, or impermeable soil layer. The construction of a shallow or elevated system is permissible where there is a suitable layer of soil, sufficient room, and the natural slope is not excessive. Shallow and elevated soil absorption systems presently approved for use are shallow fields, shallow beds, elevated fields, and unique systems designed for specific situations. Shallow systems are similar to the standard absorption field and they may receive consideration for new residences.
6.8.b. Use of shallow and elevated systems using gravity distribution may receive approval under conditions where pervious rock table, an impermeable layer of any type, or seasonal water table is less than 4.5 feet of the ground surface, on either level topography or sites of up to approximately 15% slope. When additional treatment precedes shallow or elevated fields, or designed as low-pressure distribution systems, the Commissioner may waive the separation distance to an impermeable layer, or seasonal water table from three feet to two feet. Due to a potential for groundwater contamination, the depth to pervious rock table shall not be less than three feet from any portion of the soil absorption system. Slope limitations of 15 % do not apply to low pressure systems.
6.9. Shallow Field.
6.9.a. The construction of shallow systems shall in general be in accordance with the procedures and requirements for standard absorption fields. However, the depth of the trenches in natural ground may vary from 12 to 18 inches. The space between trenches may vary from six to 12 feet, and the depth of cover material may vary from six to 12 inches, depending on the trench depth.
6.9.b. There shall be cover material placed prior to the construction of the trench system.
6.9.c. Topography of the site may be level, less than 3% slope, or up to 15% slope if using a serial-type distribution system.
6.9.d. The percolation rate for design considerations shall be the rate recorded for the natural soil at installation depth.
6.9.e. Elevated Systems are systems installed at a depth of six inches into the original ground and have a portion of the gravel or distribution piping in select fill above the original ground. All applicable provisions of subsection 6.2 of this rule apply to elevated systems.
6.10. Individual Sewage Systems with Surface Water Discharge.
6.10.a. Individual systems with surface water discharge may receive consideration for approval under the following conditions:
6.10.a.1. To correct existing failures when other means of treatment and disposal have proven ineffective; and
6.10.a.2. On lots greater than two acres in size that cannot qualify for standard or shallow soil absorption systems. All mechanical systems with surface water discharge shall have a perpetual maintenance agreement as approved by the Commissioner.
6.11. Individual Home Aeration Units.
6.11.a. Individual home aeration units shall be used only when there is a provision for additional treatment, such as soil absorption or other means of effluent disposal approved by the Commissioner. The Commissioner may require ownership, operation, and maintenance of a home aeration unit to be under the control of a public or private utility regulated by the Public Service Commission.
6.11.b. Individual home aeration units shall bear the NSF seal demonstrating conformance with NSF Standard 40 or another recognized testing agency approved by the Commissioner.
6.11.c. Individual home aeration units may receive approval providing an applicant meets the following criteria:
6.11.c.1. Shall have a perpetual maintenance agreement approved by the Commissioner;
6.11.c.2. May use Class I NSF plants or equivalent where there is surface water discharge; and
6.11.c.3. May use Class II NSF plants or equivalent where there is a provision for additional treatment.
6.12. Intermittent Surface Sand Filters.
6.12.a. Effluent from a home aeration unit may discharge to intermittent surface sand filters.
6.12.b. Effluent from a surface sand filter may discharge to a stream after disinfection in accordance with the regulations and requirements pertaining to surface discharge of wastewater.
6.12.c. The design of intermittent surface sand filters preceded by a home aeration unit shall be on a filtration rate of 10 gallons per day per square foot. There shall be two filters of design size to provide for alternation of operation.
6.12.d. Intermittent surface sand filters serving individual sewage systems shall have an insulated cover.
6.12.e. The intermittent surface sand filter shall receive dosing by either a pump or sewage siphon.
6.13. Composting Toilets.
6.13.a. Utilization of composting toilets may be only in conjunction with an approved grey water treatment and disposal system.
6.13.b. The design and construction of a composting toilet shall meet the requirements of NSF Standard 41.
6.14. Incinerating and Chemical Toilets.
6.14.a. Use of incinerating and chemical toilets may be only in conjunction with an approved grey water disposal system.
6.14.b. The design, construction, and application of incinerating or chemical toilets shall receive approval by the Commissioner. The use of chemical or incinerating toilets may receive approval by the Commissioner in emergency situations, temporary usage situations, or for recreational residences, or isolated residences.
6.15. Grey Water Disposal Systems.
6.15.a. Those houses served by a grey water disposal system shall have a house sewer of not more than two inches in diameter.
6.15.b. Houses served by grey water disposal systems shall not have garbage disposal units connected to the grey water disposal system.
6.15.c. Manufactured grey water disposal systems shall receive approval by the Commissioner.
6.15.d. Non-commercial grey water disposal systems shall consist of the following:
6.15.d.1. A soil absorption field designed on the basis of a 30 percent reduction in water usage, and constructed in accordance with the design requirements for the standard soil absorption fields; and
6.15.d.2. A septic tank sized according to the following:
6.15.d.2.A. For four or fewer bedrooms, the minimum tank capacity shall be 1,000 gallons; and
6.15.d.2.B. For each additional bedroom, the minimum tank capacity shall be 250 gallons per bedroom.
6.16. Privies.
6.16.a. Every privy shall equip:
6.16.a.1. An earthen bottom pit or a watertight vault or other watertight receptacle with walls extending at least six inches above ground level.
6.16.a.2. A crowned curb constructed of compacted earth or other suitable material, at least six inches thick, extending from the top of the walls of the pit, vault, or receptacle, in all directions over the surface of the ground for a distance of 18 inches.
6.16.a.3. A riser that is fly tight when not in use.
6.16.a.4. There shall be an enclosed superstructure constructed with a vent pipe extending from the pit, vault, or receptacle to a point at least 24 inches above the roof of the of the superstructure or through the wall of the superstructure. The vent shall have a screen to prevent the entrance of flies and other insects.
6.16.a.5. Privy pits may have an earthen bottom if:
6.16.a.5.A. The location of the privy is below and 100 feet or more from a groundwater supply or individual well, and its location is so that the disposal of any leaching from there is in a manner that does not create a nuisance or insanitary condition.
6.16.a.5.B. The pit is four feet or less in depth and determined by the excavation of a seven-foot hole that rock or water table does not exist within three feet of the bottom of the pit.
6.16.a.6. There shall be no privy located within 20 feet of any dwelling, roadside cut, stream, establishment, or within 10 feet of any property line.
6.16.a.7. The construction and design of the privy superstructure, vault, pit, or other type receptacle shall be such as to prevent access to the vault or receptacle and the contents thereof, by flies, rats, and wild or domestic animals.
6.16.a.8. Privy vaults, pits or receptacles shall have the contents removed as often as necessary to prevent creating a nuisance or unsanitary condition.
6.16.a.9. There shall be an approved grey water disposal system installed to serve those residences with indoor plumbing or running water for sinks and showers. For those residences without indoor plumbing, there shall be a shallow leach trench installed for disposal of grey water as approved by the Commissioner.
6.17. Recirculating Toilets.
6.17.a. Recirculating toilets and the piping for the toilets shall be separate from and not connected to the potable water system of any residence or other structure under any circumstances. There shall be color coded pipe used to facilitate inspection and maintenance of the installations.
6.17.b. Recirculating toilets shall:
6.17.b.1. Be installed and operated in accordance with the manufacturer's instructions; and
6.17.b.2. Be approved by the Commissioner before installation.
6.18. Self-Contained Excreta Disposal Systems.
6.18.a. The design of self-contained excreta disposal systems shall be so as to prevent flies, rats, and wild or domestic animals from having access to the contents thereof.
6.18.b. The construction of all fixtures, tanks, or receptacles shall be of impervious, easily cleanable material.
6.18.c. Tanks and receptacles shall:
6.18.c.1. Be watertight and vented to the outside air;
6.18.c.2. Be constantly supplied with sufficient amounts of an approved chemical agent to process and deodorize the contents thereof; and
6.18.c.3. Have the contents removed and the tank or receptacle thoroughly cleaned as often as necessary to prevent creating a nuisance, or an unsanitary condition.
6.19. Sewage Holding Tanks.
6.19.a. The approval of sewage holding tanks shall only be for new construction after a contract awarded for the development of a public or private sewage collection system or treatment facility, or both, to serve the proposed new construction.
6.19.b. A holding tank shall be watertight and constructed of the same materials and by the same procedures as a watertight septic tank.
6.19.c. The liquid capacity of the holding tank shall be sufficient to contain a one-week design flow from the facility it is to service.
6.19.d. The location of holding tanks shall be in an area readily accessible for pumping under all weather conditions and where accidental spillage during pumping presents the least hazard to public health.
6.19.e. The location of holding tanks shall be in accordance with the distance requirements established for septic tanks in subsection 6.2 of this rule.
6.19.f. Construction and installation of the holding tank shall provide adequate access to the tank for pumping, cleaning and maintenance through manhole and cleanouts.
6.19.g. A holding tank installation shall equip an audiovisual high-level alarm when the tank is approximately two-thirds full and shall require pumping shortly. The location of the alarm shall be inside the facility served.
6.19.h. A contract with a licensed sewage tank cleaner with a valid permit for pumping and maintenance of the tank on a regular schedule shall be required.
6.19.i. A letter from a wastewater treatment plant owner accepting the pumpings shall be a requirement. This facility shall be approved by the Commissioner. There shall be an examination of the receiving wastewater treatment plant to ensure there shall be adequate treatment, and there shall be no effect on the normal operation of the wastewater treatment plant.
6.19.j. When it is necessary to protect the public health, the Commissioner reserves the right to require additional assurances before approving holding tanks.
6.20. Alternative and Experimental Sewer Systems.
6.20.a. The construction of alternative and experimental sewer systems may be where there is a suitable layer of soil, sufficient area and the natural slope is not excessive.
6.20.b. Alternative soil absorption systems presently approved for use are shallow fields, soil absorption mounds, shallow beds, low pressure pipe systems, elevated fields, evapotranspiration systems and unique systems designed for specific situations.
6.20.c. Alternative soil absorption systems may receive consideration for new construction on lots two acres and over providing soil and site limitations can be met.
6.21. Effluent Pumping for Individual Sewer Systems.
6.21.a. Pump type shall be non-clog submersible centrifugal effluent pumps or progressing cavity positive displacement pumps.
6.21.b. Pumps shall be readily removable and replaceable without dewatering the wet well.
6.21.c. The pump size should be to dose a soil absorption system two to four times a day. The recommended dosing cycle is twice a day; however, the dose shall be no more than 75% of the distribution pipe volume for all soil absorption systems using four-inch pipe.
6.21.d. The location of the pump shall be six to eight inches off the tank bottom to provide additional volume for sludge settlement.
6.21.e. The location of relays and electrical plug-ins or sockets shall not be inside the wet well or access manhole. The location of the devices must be above-ground in a weatherproof box or in the residence.
6.21.f. There shall be a high-water alarm placed within the residence.
6.21.g. Pipe used for the distribution system, the force main, shall be PVC SDR 21, PVC SDR 26, or Schedule 40, 1.25 to two-inch diameter.
6.21.h. All parts of the distribution system, the manifold, and laterals, shall slope slightly toward the inlet to avoid freezing and ponding of water in the system between dosing.
6.21.i. The installation of piping shall be below the frost line.
6.21.j. The wet well shall be watertight and constructed of materials that will not corrode.
6.21.k. The wet well shall have an access manhole of 24 inches or greater in diameter. The installation of the manhole shall be level with or above the ground surface and the cover secured.
6.21.l. The size of a wet well shall be to provide adequate volume not only for one day reserve capacity, but also for single dose capacity plus additional capacity to maintain minimum depth for operation.
6.21.m. The wet well tank shall be set lower than the septic tank to provide usage of maximum capacity of the wet well.
W. Va. Code R. § 64-47-7 Sewage Tank Cleaning
7.1. General.
7.1.a. Necessary hand tools such as picks and shovels, and other items such as sand and cement for repairing concrete sewage tanks shall be carried on the sewage cleaning vehicle.
7.1.b. All portable receptacles used for transporting the contents of sewage tanks shall be of approved construction, metal or equivalent, easily cleanable, good repair, equipped with tightfitting lids, and shall be cleaned, deodorized and disinfected daily or more often, if needed.
7.2. Motor Vehicle and Chassis.
7.2.a. The motor vehicle and its chassis shall be of sufficient capacity to haul all equipment necessary for the transporting, pumping, filling, emptying, and cleaning of sewage tanks.
7.2.b. Sewage tank cleaning motor vehicles may be of one unit or of the tractor-trailer type, but regardless of the type, the motor vehicles shall be in compliance with all applicable provisions of this rule.
7.2.c. All vehicles used in these operations shall carry in a conspicuous place the name and address of the firm or operator under which business is conducted. All lettering shall be at least two inches in height.
7.3. Carrier Tank.
7.3.a. The carrier tank shall be fully enclosed, leakproof, fly-proof, and operated in such manner as to prevent spillage during the collection, removal, transportation, and disposal of the sewage tank contents.
7.3.b. The carrier tank shall be of heavy gauge metal, preferably 10 to 12 gauge or equivalent, to withstand the treatment to which it will be subjected.
7.3.c. The carrier tank shall have a capacity of at least 750 gallons, but preferably 1,000 gallons, to readily hold the accumulation of the average size sewage tank serving a one-family dwelling.
7.3.d. The capacity of the carrier tank, in gallons, shall be conspicuously painted on the side of said tank.
7.3.e. The carrier tank shall be constructed so as to permit proper cleaning of the interior and exterior of it.
7.3.f. The exterior of the carrier tank shall be painted, and the tank and appurtenances kept clean and in a state of good repair.
7.3.g. The carrier tank shall be conspicuously and permanently labeled near the outlet valve in letters at least two inches high, “FOR SEWAGE ONLY,” and the carrier tank shall not be used for any other purpose.
7.3.h. The health department permit number for the sewage tank cleaner shall be prominently displayed on the carrier tank.
7.3.i. The carrier tank shall have a manhole in the top to provide for easy access to the tank interior for flushing and cleaning purposes. The manhole may be in combination with, or separate from, the filling connection.
7.3.j. The carrier tank shall have an outlet valve located so that the entire contents of the tank can be drained.
7.3.j.1. The outlet valve opening shall be at least three inches in diameter and shall have a non-leaking, non-clog type valve for draining the tank;
7.3.j.2. The outlet valve shall be adapted for a standard hose connection to the pump for recirculating the contents of the tank if required prior to emptying or for pumping to the disposal site if gravity draining is not feasible;
7.3.j.3. In pumping from the carrier tank, an air inlet is recommended to prevent collapsing the tank; and
7.3.j.4. The outlet valve shall be capped when not in actual use to prevent leaking or spilling of the tank contents. Caps shall be secured by chain to outlet valve or tank.
7.3.k. Facilities shall be available for the flushing, cleaning, and deodorizing of sewage tanks, carrier tanks, and sewage tank cleaning implements or equipment according to the following:
7.3.k.1. A direct connection to a water distribution system for the flushing or cleaning action shall only be used when the water distribution system is protected by one or more approved and properly located back-siphonage prevention devices.
7.3.k.2. Wastes resulting from the flushing or cleaning operation shall be disposed of in accordance with 64CSR9.10, Sewer Systems, Sewage Treatment Systems and Sewage Tank Cleaners, and 33CSR2.3 Sewage Sludge Management.
7.3.k.3. Odor controlling substances may be left in the sewage tank, carrier tank or other sewage tank cleaning implement or equipment, but in no case shall these substances be used in lieu of proper cleaning.
7.4. Pumps and Hoses.
7.4.a. All pumps used for sewage tank cleaning purposes shall be of the non-clog, self-priming type and shall be capable of handling the contents of sewage tanks.
7.4.b. The use of potable water under pressure to prime pumps or to operate aspirators is prohibited.
7.4.c. Pumps and pump bases shall be of such construction that they can be easily handled and used for purpose intended.
7.4.d. Hoses shall be of sufficient length for recirculating the contents of the sewage tank or carrier tank and to reach the point of discharge at the disposal site readily.
7.4.e. Hoses shall be flexible and constructed so that they can be readily cleaned.
7.4.f. Hoses shall be kept clean and in a good state of repair.
7.4.g. Hoses shall be used and stored in such manner as to prevent leaking, spilling, and dripping of any sewage tank contents.
7.4.h. When not in actual use hoses shall be tightly capped.
W. Va. Code R. § 64-47-8 Septage Treatment and Disposal
8.1. Public Sewage Treatment Plant.
8.1.a. If permission is granted to the septage hauler for disposal of septage, the owner and operator of the public sewage treatment plant shall grant permission in writing.
8.1.b. The disposal of septage shall not be in a public sewage treatment plant treating less than 100,000 gallons per day, unless providing pre-treatment.
8.2. Lagoons.
8.2.a. The soil conditions shall be such that a minimum of four feet of soil exists between the bottom of the lagoon and the high groundwater table and rock table for permeable soils and a minimum of two feet of soil exists between the bottom of the lagoon and the high groundwater table and rock table for impermeable clay soils.
8.2.b. The lagoon site shall be free of rock outcroppings and shall be out of the 25-year flood plain.
8.2.c. All surface water shall be diverted from the lagoon and there is to be no discharge from the lagoon.
8.2.d. Maximum depth of the lagoon shall be no greater than six feet with one foot freeboard.
8.2.e. Inside and outside slopes shall be no greater than three to one unless proposing some type of side reinforcement, for example: rip-rap.
8.2.f. A six-foot high fence with a locked entrance gate shall enclose the lagoon or made inaccessible to the public through location or other means.
8.2.g. The location of the lagoon shall not be within 1,000 feet of any existing occupied buildings.
8.2.h. Disposal lagoons require placement of septage in small incremental lifts six to 12 inches and sequential loading of another lagoon or lagoons for optimum drying. Therefore, this rule requires a minimum of two lagoons.
8.2.i. Two feet of soil shall be placed as a final cover when septage fills the lagoon, and it is no longer usable.
8.2.j. If re-using the lagoon is an option, it is required to retain the septage for a minimum of 90 days after discharging the last load.
8.2.k. After the minimum 90-day storage in the lagoons, an applicant may land dispose the septage either by landfilling or land spreading.
8.2.l. There shall be immediate covering of lagoon contents after landfilling or land spreading.
8.2.m. Land spreading of lagoon contents on fields used for growing crops for human or animal consumption is generally not recommended due to the potentially highly infectious nature of the waste. However, fields used for land spreading may be useful for animal forage crops provided the fields are fallow for a minimum of six months after the last application and prior to the first plantings of the forage crops.
8.3. Lime Stabilization.
8.3.a. The addition of lime in sufficient quantities shall stabilize septage and destroy pathogenic organisms. There is no destruction of organic matter or solids reduction during the lime stabilization process.
8.3.b. The mixing together of the septage and lime shall take place until reaching a pH greater than 12.
8.3.c. The mixture shall maintain a pH greater than 12 for a minimum of two hours.
8.3.d. Achieving the mixing process shall be through diffused air mixing or by mechanical mixers.
8.3.e. When land disposing the mixture, an applicant shall follow the requirements outlined in 33CSR2, Sewage Sludge Management.
8.4. Other Methods.
8.4.a. Other methods of septage treatment and disposal are composting, pressure chlorination, electron treatment, incineration, and conventional waste treatment. The Commissioner shall review these methods of septage treatment and disposal on a case-by-case basis.
W. Va. Code R. § 64-47-9 Animal Waste Handling Facilities
9.1. General. The design and construction of animal waste handling facilities shall be in accordance with the current issue of the U.S. Department of Agriculture Soil Conservation Service, Agriculture Waste Management Field Manual.
W. Va. Code R. § 64-47-10 Grease Traps
10.1. There shall be grease traps for all restaurants and similar establishments where a large quantity of grease and fats in liquid wastes will occur.
10.2. The location of the external grease trap shall be within 30 feet from the fixtures served. If meeting this distance requirement is not possible and thus, external grease traps are not possible due to existing conditions or physical limitations, the Commissioner may allow internal grease traps.
10.3. Only those plumbing fixtures into which the grease and fats are discharging shall connect to the grease trap.
10.4. The external grease trap shall be a minimum 150 gallons capacity. Larger grease traps may be a requirement depending upon the loading.
10.5. The external grease trap shall be in an easily accessible place outside the building served.
10.6. Grease traps with manhole covers shall be designed to withstand expected loads and prevent access by children.
10.7. The manhole cover shall be secured by a bolt or locking mechanism and be constructed of round cast iron or similar construction with sufficient weight to prevent unauthorized access.
10.8. The Commissioner may specify either method of limiting access to the manhole, if the method conforms to subsection 10.7 of this section and prevents unauthorized access.
10.9. A hotel or restaurant shall ensure that a grease trap manhole is closed and secured or locked, if applicable, at all times, except when accessed for pumping or maintenance.
W. Va. Code R. § 64-47-11 Administrative Due Process
Those persons adversely affected by the enforcement of this rule desiring a contested case hearing to determine any rights, duties, interests, or privileges shall do so in a manner prescribed in the Rules of Procedure for Contested Case Hearings and Declaratory Rulings, 64 CSR 1.
W. Va. Code R. § 64-47-12 Enforcement
This rule is enforced under W. Va. Code §16-1-6, §16-1-9, §16-1-17, §16-1-18 and other applicable code provisions.
TABLE 16-47-A.- APPLICATION PACKAGES
Package Type of System A Collection System Only B Collection and Treatment System (100,000 gallons per day or less)
C Collection and Treatment System (100,000 gallons per day or greater)
D Individual on-site Sewage Collection and Treatment System E Subdivision Using Individual Sewage Disposal Systems F Mobile Home Parks TABLE 64-47-B.- MINIMUM DESIGN LOADINGS FOR SEWAGE TREATMENT FACILITIES Facility Description Unit Sewage Design Flow (gpd)
Unit Five-Day BOD (lbs/day)
Airports Each employee Each passenger .05 Assembly halls Per seat Bowling alleys (no food service)
Per alley Per alley with bar .13 **Brewery Per seat manufacture and sampling only Per seat with ABCA License for onsite consumption by the glass1 Churches Per member with kitchen Per member without kitchen **Cidery Per seat manufacture and sampling only Per seat with ABCA License for onsite consumption by the glass1 Clinics Per staff Per patient Country clubs Per member (non-resident)
Per member (resident) .05 **Distillery Per seat manufacture and sampling only Per seat with ABCA License for onsite consumption by the glass1 Domestic sewage Residences (per resident -a-)
New collection system Summer cottages, etc., per resident Apartment houses—one bedroom —two —three .17* .34 .51 .60 Factories (per worker)
Heavy with café and shower Light with café Light with shower Light Hospitals Each patient (bedside)
Each resident staff Each non-resident staff .34 Hotels, boarding houses (Exclusive of restaurants, bars) per guest .15 Industrial park (sanitary waste only)
Per developable acre .84 Institutions Per resident Laundry (coin operated)
Per machine
1.34 Labor camps Per person Mine bath houses Per worker Mobile homes Per mobile home .68 Motels (exclusive or restaurant or bar)
Per unit .15 Nursing and rest homes Per resident Per resident staff .26 Offices and warehouses Per workers, no food service Add for food service, per worker Recreation Parks, picnic areas, and beach areas Campground, per person Amphitheater, per person Historical site, per person Lodges, per person Park residences, per person Park washhouse, per person .05 .05 Restaurants 24-hour service, per seat Ordinary, not 24-hour service, per seat Curb service (drive-in), per car space Fast food (single service), per seat .10 .06 Schools Elementary, each staff or student High school, each staff or student Boarding school Service stations Ordinary, not 24-hour service 24-hour service .80
1.60 Shopping mall per l00 sq. ft.
Shopping center Based on individual store occupancy Swimming pools Per swimmer Add for shower facilities, per swimmer Taverns and bars, little or no food service Per seat Theaters Drive-in, per car space Movie, per seat .008 .004 Travel Trailer Park (b)
No water to site, per person Water to site, per person .075 .10 **Winery Per seat manufacture and sampling only Per seat with ABCA License allowing on site consumption by the glass 1 Disco/Dance Halls, per seat Beauty parlors/barber shops Per chair Per operator .50 Dentist Per chair Per staff .10 Doctor Per patient Per staff (a) Assume four persons per residence (b) Assume three persons per travel trailer site *See subsections 5.1.d.3., 5.1.d.4., 5.1.d.5. ** A calculation should be based upon an average of winter (November – March) usage and summer (April – October) usage 1 Requirement of the ABCA License is that there must be food offered for sale onsite by the facility or an outside food or mobile food vendor (NOTE 1: These factors do not apply to the design of municipal sewage systems. Refer to subsection 6.1. for design loadings for municipal sewage systems.)
(NOTE 2: If proposed facilities are not listed in the table above, and average daily water usage data is available, a peaking factor of 2.5 shall be required.)
(NOTE 3: Five-Day BOD, BOD5 or BOD5 is the scientific method used to accurately measure dissolved oxygen consumption, by comparison of dissolved oxygen in a sample at the beginning and at the end of a five-day period.)
TABLE 64-47-C.- MINIMUM SLOPES FOR SANITARY SEWERS
Sewer Size Minimum Slope in feet per 100 feet 6"
0.62 8"
0.40 10"
0.28 12"
0.22 14"
0.17 15"
0.15 16"
0.14 18"
0.12 21"
0.10 24"
0.08 27" and larger
0.07 TABLE 64-47-D.- SPARE PUMPS FOR PRESSURE SEWER SYSTEMS
Installed Units Spare Units 1 to 10 11 to 20 21 to 30 31 to 40 41 to 50 51 to 75 76 to 100 101 to 150 151 to 200 201 to 300 301 to 400 401 to 500 501 - up As approved by the Commissioner TABLE 64-47-E.- BUFFER ZONE REQUIREMENTS FOR SEWAGE TREATMENT WORKS Treatment Facilities Buffer Zone Requirements (feet)
Sewage Treatments Plants: 40,000 GPD or less 40,001 - 100,000 GPD greater than 100,000 GPD Other Treatment Facilities:
Polishing ponds Package sand filters Alternating surface sand filters TKN removal equipment Aerated lagoons Constructed wetlands Recirculating sand filter systems Stabilization ponds Trickling filters Land treatment systems These requirements DO NOT APPLY to existing treatment works that are being upgraded or expanded.
TABLE 64-47-F.- WASTEWATER TREATMENT PLANT LINE COLOR CODE
Type of Line Color Sludge line Brown Gas line Orange Potable water line Blue Chlorine line Yellow Sewage line Gray Compressed air line Green Water lines for heating digesters or buildings Blue with 6-inch red bands spaced 30 inches apart TABLE 64-47-G.- PERMISSIBLE AERATION TANK CAPACITIES AND LOADINGS Process Aeration Tank Organic Loading--lb.BOD5***/day per 1000 cu. ft.
F/M Ratio lb.BOD5***/day per lb.MLVSS MLSS* mg/litter Conventional step aeration complete mix 0.2-0.5 1000-3000 Contact stabilization 50** 0.2-0.6 1000-3000 Extended aeration 3000-5000 oxidation ditch 0.05-0.1 *MLSS values are dependent upon the surface area provided for sedimentation and the rate of sludge return as well as the aeration process. **Total aeration capacity, includes both contact and reaeration capacities. Normally the contact zone equals 30 to 35% of the total aeration capacity. ***BOD5 or BOD5 is the scientific method used to accurately measure dissolved oxygen consumption, by comparison of dissolved oxygen in a sample at the beginning and at the end of a five-day period.
TABLE 64-47-H.- WASTEWATER TREATMENT PLANT MINIMUM AIR REQUIREMENTS
Process Cubic Feet of Air Available Per lb. of BOD5* Loan in Aeration Tank Conventional Step aeration Contact stabilization Modified or "High-Rate" 400 to 1500 (depending on BOD5* removal expected)
Extended aeration *BOD5 is the scientific method used to accurately measure dissolved oxygen consumption, by comparison of dissolved oxygen in a sample at the beginning and at the end of a five-day period.
TABLE 64-47-I.- RETURN SLUDGE RATE
Minimum Maximum Standard rate Carbonaceous state of separate stage nitrification Step aeration Contact stabilization Extended aeration Nitrification stage of separate stage nitrification TABLE 64-47-J.- MEDIA SIZE/GRADING Passing 4½-inch screen 100% by weight Retained on 3-inch screen 95-100% by weight Passing 2-inch screen 0-2% by weight Passing 1-inch screen 0-1% by weight TABLE 64-47-K.- MINIMUM HORIZONTAL SEPARATION DISTANCES BETWEEN SOIL ABSORPTION SYSTEMS AND NATURAL AND MANMADE FEATURES Distance Feature 10 feet Foundation drain upslope from disposal area. 20 feet Stream banks and open drainage features, whether manmade or natural. 20 feet Manmade cuts in soil and curtain drains. 20 feet Foundation drains downslope from disposal area. 50 feet Manmade cuts that intersect rock or shale. 100 feet Water supply springs and water supply wells. 50 feet Water supply cistern TABLE 64-47-L.- STANDARD SEPTIC TANK SOIL ABSORPTION SYSTEM SIZING FOR SINGLE-FAMILY DWELLINGS Percolation Test Results (Average Time in Minutes Required for Water to Fall One Inch)
Minimum Area of Soil Absorption System (Square Feet per Bedroom)
Less than 5 minutes Consult with local health department 5 - 30 minutes 31 - 60 minutes over 60 minutes Consult with local health department TABLE 64-47-M.- SINGLE ABSORPTION SYSTEM SIZING FOR ESTABLISHMENT OTHER THAN SINGLE-FAMILY DWELLING Percolation Test Results Square Feet Per 1000 Gallons Sewage Per Day Less than 5 minutes Consult with your local health department 5 - 10 minutes 11 - 30 minutes 31 - 45 minutes 46 - 60 minutes over 60 minutes Consult with your local health department
Series 48 Emergency Medical Services
W. Va. Code R. § 64-48-1 General
1.1. Scope. -- This rule is intended to ensure adequate provision of emergency medical services to the residents of West Virginia and to meet the purposes set out in W. Va. Code §16-4C-2 to provide clear direction to emergency medical services (EMS) personnel and agencies in West Virginia.
1.2. Authority. -- W. Va. Code §16-1-4, §16-4C-6, §16-4C-14, and §16-4C-23.
1.3. Filing Date. -- April 13, 2026.
1.4. Effective Date. -- July 1, 2026.
1.5. Sunset Provision. -- This rule shall terminate and have no further force or effect August 1, 2031.
1.6. Applicability. -- The provisions of this rule are not intended to limit the scope of practice of any person who is a licensed health care provider under other pertinent provisions of West Virginia law and who is acting within the scope of his or her license. This rule applies to all persons or entities defined in W. Va. Code §16-4C-14 and §16-4C-3 and to all other persons or entities engaging in the provision of EMS in West Virginia.
1.7. Enforcement. -- This rule is enforced by the Secretary of the Department of Health.
W. Va. Code R. § 64-48-2 Definitions
2.1. Advanced Emergency Medical Technician (AEMT) -- A person licensed as an Advanced Emergency Medical Technician.
2.2. Advanced Life Support (ALS) -- A level of EMS which includes, but is not limited to, the assessment, treatment, and transportation of sick and injured persons, invasive and non-invasive medical procedures, the administration of medications and BLS procedures as approved for the appropriate level of licensure by the OEMS Medical Direction System.
2.3. Air Ambulance -- An aircraft configured and medically equipped to transport patients by air. The patient care compartment of air medical ambulances shall be staffed by a licensed medical crew meeting the requirements of this rule.
2.4. Agency Medical Director -- A West Virginia licensed physician who meets the requirements of subdivision 9.1.1. of this rule, and accepts responsibility for providing medical oversight, medical performance review, and extending privilege to practice to a licensed EMS agency and its personnel under the guidelines established by OEMS.
2.5. Basic Life Support (BLS) -- A level of EMS which includes, but is not limited to, assessment, treatment, and transportation of sick and injured persons, including medical procedures, the administration of limited medications, basic life-saving procedures, and continuous medical supervision as approved for the appropriate level of licensure by the OEMS Medical Direction System.
2.6. Certification -- The process by which a person acquires a license as an EMS personnel for a level in which he or she is not currently certified in this state.
2.7. Certification Transfer -- The issuance of licensure through reciprocity, legal recognition, or equivalency based on prior training, certification, or licensure in another state, commonwealth, territory, or the United States military.
2.8. Communications Center -- A facility that receives calls for emergency assistance and dispatches the appropriate responders to EMS incidents for a particular geographic area. These facilities include, but are not limited to 9-1-1 centers, stand-alone dispatch centers, and other public safety answering points.
2.9. Community Paramedic -- A person licensed as a Community Paramedic.
2.10. Community Paramedicine -- A type of non-emergent ALS service where direct care is provided without transport.
2.11. CPR – Cardio-Pulmonary Resuscitation.
2.12. Criminal history background check -- A report from a criminal history record system maintained by federal or state governmental agencies that is based on fingerprint identification.
2.13. Critical Care Transport -- A level of sophisticated, specialized medical care and transportation requiring specifically trained, skilled, and equipped personnel operating under guidelines established by the OEMS Medical Direction System.
2.14. Data System -- An electronic system designated by OEMS for the collection, storage, and retrieval of all information relating to the provision of EMS including, but not limited to, electronic patient care records, emergency medical services toolkits, medical command data, and other specialized data collections.
2.15. Director of the Office of Emergency Medical Services, OEMS Director, or Director -- The Director of OEMS within the Department of Health.
2.16. Disaster -- A natural or man-made occurrence which creates need for the provision of EMS which exceeds the capacity of prompt provision of care or transportation by the EMS providers in the immediate area of the occurrence.
2.17. Emergency Medical Dispatcher (EMD) -- A person licensed as an Emergency Medical Dispatcher.
2.18. Emergency Medical Responder (EMR) -- A person licensed as an Emergency Medical Responder.
2.19. Emergency Medical Service Agency or EMS agency – A person or entity licensed to provide EMS.
2.20. Emergency Medical Services Vehicle (EMS vehicle) -- EMS transportation vehicles including: ambulances, air ambulances, and other patient transportation vehicles, and non-transporting, medically equipped vehicles operated by licensed EMS agencies as described in this rule. EMS vehicles include any private or publicly owned vehicle or craft intended to provide on-scene EMS or patient transportation.
2.21. Emergency Medical Technician (EMT) -- A person licensed as an Emergency Medical Technician.
2.22. Emergency Medical Vehicle Operator (EMVO) -- A person licensed as an Emergency Medical Vehicle Operator.
2.23. Incident -- An event which generates a request to provide EMS assessment, treatment, or transportation by EMS agencies and personnel. Incidents include, but are not limited to 9-1-1 response, non-emergency transportation, inter-facility transport, patient refusals of care, no care needed or provided, and standby in support of other emergency responses or emergency events.
2.24. Inspector -- A person authorized by OEMS to inspect EMS agencies, vehicles, training institutions, or other facilities as necessary.
2.25. Investigator -- A person authorized by OEMS to conduct investigations on behalf of the Secretary.
2.26. Local System -- A coordinated arrangement of resources organized to provide emergency ambulance service within a defined geographical area. The systems are provided under the authority of either a county commission, statutory ambulance authority, or other legislatively established entity charged with the responsibility for providing the service.
2.27. Medical Command Center -- A designated facility staffed by paramedic communications specialists, operating under medical supervision, who provide online advice and direction to EMS personnel for specific EMS incidents regarding treatment, triage, and destination decisions under the guidelines of the EMS Medical Direction System.
2.28. Medical Command Physician (MCP) -- A West Virginia licensed physician operating as part of a medical command center who provides online medical direction to EMS personnel using patient care treatment, triage, and transportation protocols and guidelines approved by OEMS. The MCP has ultimate authority and responsibility for patient care activities provided on a specific EMS incident.
2.29. Medical Direction System -- The aggregate medical resources responsible for the establishment of policies and procedures governing all aspects of the operation of the online and offline medical direction for all EMS activities in West Virginia.
2.30. Medical Facility -- Any hospital, medical clinic, physician’s office, or other similar facility, licensed or certified by the appropriate state agency, at which medical care and treatment is available.
2.31. Medical Policy and Care Committee (MPCC) -- The MPCC is composed of each regional medical director and may include physicians representing specialty areas such as pediatrics, trauma, cardiology, and others as necessary. The committee serves as the primary policy making body and advisory body to the State Medical Director concerning medical issues involving the OEMS system. The committee shall meet at least biannually, or more frequently as necessary.
2.32. Mobile Critical Care Nurse (MCCN) -- A person possessing a valid, unrestricted Registered Nurse license in West Virginia who meets OEMS requirements for paramedic certification, who has completed additional state-approved education, and meets other requirements to provide Critical Care Transport.
2.33. Mobile Critical Care Paramedic (MCCP) -- A person licensed as a paramedic who has completed additional state-approved education and meets other requirements to provide Critical Care Transport.
2.34. NEMSIS – The National Emergency Medical System Information System.
2.35. Non-Public EMS Response Entity -- A licensed EMS agency which provides EMS to a specific population and geographic area, including, but not limited to, industrial sites and military operations. The service is not accessible by or available to the general public.
2.36. OEMS -- The Office of Emergency Medical Services as created by statute in W. Va. Code §16-4C-4.
2.37. Official Representative -- An individual assigned by the licensed EMS agency with signature authority to represent the licensed EMS agency.
2.38. Offline Medical Direction -- The component of medical oversight provided to EMS personnel and agencies including, but not limited to, medical treatment protocols and guidelines, triage protocols, destination protocols, policies and procedures, determination of EMS personnel scopes of practice, privilege to practice, medical command center operation, and other issues of a medical nature.
2.39. Online Medical Direction -- The medical direction given by personnel at an approved Medical Command Center to EMS personnel at the time of an EMS incident, by voice or other means, as established by OEMS protocols and guidelines.
2.40. Paramedic -- A person licensed as a Paramedic.
2.41. PCR – Patient Care Reports.
2.42. Patient Transportation -- Movement or transfer of a patient from any location to another by an EMS vehicle licensed by OEMS.
2.43. Pilot-in-Command -- A person who possesses appropriate Federal Aviation Administration credentials and who, pursuant to this rule, is responsible for the operation of an air ambulance.
2.44. Preliminary criminal history background check -- A report from a criminal history record system maintained by federal or state governmental agencies, the source of which is approved by the Secretary, that is based on a method of positive identification other than fingerprint identification.
2.45. Primary patient caregiver -- A person licensed pursuant to this rule who has primary authority and responsibility for the care of patients with respect to the provision of EMS on a particular EMS incident.
2.46. Privilege to practice -- Authority to perform those skills and procedures defined within the scope of practice established by the OEMS Medical Direction System for a particular level of licensure granted by the agency medical director with concurrence of the State Medical Director.
2.47. Protocol -- A document developed and approved by the MPCC that describes the diagnostic procedures, treatment procedures, medication administration, and patient care practices that shall be completed by EMS personnel within their scope of practice based upon the assessment of a patient, and the scope of practice of the primary patient caregiver.
2.48. Rapid response -- A form of EMS designed to provide an initial response service to improve EMS incident response time and patient outcome. Rapid response services shall be coordinated as part of a local EMS System or licensed EMS agency. Rapid response EMS personnel operating under the OEMS Medical Direction System, provide on-scene assessment, intervention, and treatment without patient transportation.
2.49. Recertification -- The process by which EMS personnel renew an EMS certificate for which they are or were licensed in this state.
2.50. Regional EMS Medical Director -- A West Virginia licensed physician, recommended by a regional EMS Board of Directors and by the State Medical Director, appointed by the Secretary to oversee medical aspects of EMS within a particular geographic region of the state.
2.51. Scene Flight -- Any aeromedical flight that is not an interfacility transport.
2.52. SMPMT – Specialized multi-patient medical transport.
2.53. State Medical Director -- A West Virginia licensed physician, board certified in emergency medicine, with substantial experience in emergency medicine, appointed by the Secretary, to oversee all medical aspects of the OEMS.
W. Va. Code R. § 64-48-3 Systems and Operations
3.1. Local Systems -- County commissions are encouraged to establish local systems consistent with the duty contained in W. Va. Code §7-15-1, et seq., which:
3.1.1. Define a geographical service area; and
3.1.2. Establish the minimum level of service required within the service area and ensures the established level of care is available to all citizens within that service area 24 hours per day and 365 days per year.
3.1.3. Development of a plan describing how the local system will address:
3.1.3.a. The dispatch, coordination and oversight of all agencies and personnel operating within the Local System;
3.1.3.b. The provision of sufficient numbers of permitted and staffed ambulances to provide emergency ambulance coverage to the service area 24-hours per day;
3.1.3.c. The establishment, monitoring, and reporting of system response time standards;
3.1.3.d. Integration with other county emergency management entities in the county’s all-hazard disaster plan; and
3.1.3.e. The establishment of a communication system that provides for:
3.1.3.e.1. Public access using the telephone number 9-1-1 within the public telephone network as the primary method to request assistance;
3.1.3.e.2. An emergency communications system operated by public safety telecommunicators with training in the management of calls for emergency medical assistance available 24-hours per day;
3.1.3.e.3. Dispatch of the most appropriate EMS agency or EMS vehicle to any request for assistance in accordance with a written plan for management and deployment of resources, including requests for mutual aid; and
3.1.3.e.4. Two-way voice communications from within the defined service area to the emergency communications center or Public Safety Answering Point (PSAP).
3.1.4. County commission statutory ambulance authorities or other statutory entities charged with the responsibility for providing the service should designate those transporting and non-transporting EMS agencies which are affiliated with the local system.
3.1.4.a. It is not necessary to designate air ambulance agencies and non-public response agencies.
3.1.4.b. Affiliation should be evidenced by a contract, franchise agreement, or other written documentation.
3.1.5. Local systems should designate an official contact person to be the primary contact for OEMS in all matters relating to the local system.
3.2. Data System.
3.2.1. OEMS shall participate in the NEMSIS electronic data collection project. All data collection systems shall be certified NEMSIS compliant for all state required data elements. OEMS shall maintain a list of collection programs approved for use in the state. Additionally, state approved collection programs shall be certified NEMSIS compliant for each EMS agency.
3.2.2. EMS agencies shall collect, maintain, and report accurate patient data for all incidents. Agencies shall complete a PCR for all incidents. PCRs shall be completed and submitted to the state data system following the conclusion of providing services to a patient, in accordance with policies and guidelines established by OEMS.
3.2.3. When an ambulance transports a patient to a medical facility’s emergency room or department, at a minimum a patient handoff report, as specified by OEMS, shall be provided to the facility prior to departing. Within 72 hours of the conclusion of providing services to a patient, the EMS agency shall make a copy of the complete PCR available to the receiving facility, either electronically or written, which shall serve as the official record of the incident.
3.3. Air Ambulance Flight Data.
3.3.1. Dispatch of the appropriate air ambulance to a scene flight shall be based upon the closest distance to the scene as determined by the distance measured in aeronautical miles. In order to maintain licensure as an air ambulance agency, each air ambulance agency must provide the tracker identification associated with each air ambulance operating in the state to all communications centers for the purpose of dispatching the appropriate air ambulance.
3.3.2. OEMS shall have the right to inspect any flight data system maintained by an air ambulance agency containing data related to aeromedical flights occurring within the state and may, at its option, purchase and maintain a state-based flight data system.
3.3.3. Unauthorized alteration of scene flight data by any air ambulance agency or communications center shall constitute a violation of this rule.
W. Va. Code R. § 64-48-4 Agencies
4.1. The Secretary shall evaluate EMS agencies according to this rule.
4.2. Responsibility. -- EMS agencies are responsible for ensuring that vehicles operated and maintained by the agency and personnel associated with the agency comply with this rule at all times.
4.3. License Required. -- A person or entity may not establish or operate and maintain or advertise any service or organization as an EMS agency without a valid OEMS license.
4.4. Display of License. -- The license shall be displayed publicly in the headquarters of the agency.
4.5. Licensed Service Types. -- EMS licenses shall be issued for one or more of the following services:
4.5.1. Rapid response -- BLS;
4.5.2. Rapid response -- ALS;
4.5.3. BLS;
4.5.4. Community paramedicine;
4.5.5. ALS;
4.5.6. Critical care transport;
4.5.7. Rotary wing transport;
4.5.8. Fixed wing transport;
4.5.9. Specialized multi-patient medical transport. This type of service may not be licensed unless the EMS agency provides at least BLS service; and
4.5.10. Fire Department Rapid Response. -- This applies only to fire departments certified by the West Virginia State Fire Commission.
4.5.10.a. A fire department rapid response service that charges a fee for its medical services or transports patients is subject to all licensure requirements and applicable standards of this rule, including the payment of fees.
4.5.10.b. A fire department rapid response service that does not charge a fee for its medical services or transport of patients shall obtain one of the following:
4.5.10.b.1. A license subject to all requirements and applicable standards of this rule, including full inspection and payment of fees; or
4.5.10.b.2. A license subject to requirements and applicable standards of this rule as outlined in subsection 4.10. of this rule.
4.5.10.c. A fire department rapid response service certified by the West Virginia State Fire Commission is not subject to licensure as described in this rule if it only provides BLS services pursuant to an agreement with an EMS agency that addresses medical direction, training, quality assurance, and liability insurance.
4.6. Advertising. -- EMS agencies shall not advertise, in print, electronic, or other media for public consumption, any service for which they are not licensed. Aeromedical agencies may not solicit direct flight requests for service from the general public. Agencies may advertise for personnel or other community-oriented activities.
4.7. Application.
4.7.1. The EMS agency shall submit an application to OEMS for a license, in a format specified by the Secretary, prior to agency inspection.
4.7.2. Any EMS agency seeking to make changes in the level of service, service area, station locations, or number of vehicles shall submit an application in a format specified by the Secretary, prior to making the change.
4.7.3. Management of an EMS agency includes those serving as Official Representative, Medical Director, or Training Officer. Any changes to management require a revised application to be submitted within 10 days of the change.
4.8. Verification. -- The Secretary may use any lawful investigatory means necessary to verify information contained in an application.
4.9. License Issuance. -- The Secretary shall determine whether an applicant is issued a license based upon: the applicant’s previous record of performance in the provision of a similar service; the resources available to the applicant for the provision of services; an objective measurement of the applicant’s compliance with requirements and standards of this rule; and evidence of the applicant’s current compliance with all state, local, and federal obligations, including, but not limited to, taxes and worker’s compensation obligations.
4.10. Inspection. -- The Secretary may inspect all places of operation of an EMS agency or proposed EMS agency, at any time, for compliance with this rule.
4.10.1. The inspection is in addition to other federal, state, or local inspections required by law.
4.10.2. The inspection will include all places of operations and all records of the EMS agency or proposed EMS agency.
4.10.3. The Secretary may inspect, but not copy or maintain, records of a protected status.
4.10.4. Fire department rapid response agency inspection:
4.10.4.a. The official representative of the agency, as indicated on the application, shall verify the applicant’s compliance with the requirements of this rule and sign and attest to compliance before a notary public.
4.10.4.b. The Secretary may inspect all places of operation of an existing or proposed fire department rapid response service for compliance with this rule. The inspection is in addition to other federal, state, or local inspections required by law. The Secretary may inspect, but not copy or maintain, records of a protected status.
4.10.4.c. Inspections shall be conducted at no cost to the applicant.
4.11. Place of Operations. -- EMS agencies shall comply with the following requirements pertaining to all places of operations:
4.11.1. Storage. -- The EMS agency shall provide adequate and clean storage spaces in an enclosed area for equipment and supplies. These storage spaces must be constructed to permit thorough cleaning;
4.11.2. Supplies. -- The EMS agency shall maintain medical supplies required for all the classes of vehicles operated by the agency;
4.11.3. Sanitary Requirements. -- All areas used for storage of equipment and supplies must be kept neat, clean, and sanitary. Plastic bags or enclosed containers shall be provided for soiled supplies;
4.11.4. Living Quarters. -- If crews are required to work 24-hour or greater-length shifts, appropriate quarters shall be provided. These quarters shall meet standards established by W. Va. Code §21-3-1, Safety and Welfare of Employees, and others established by the Secretary; and
4.11.5. Medical Waste. -- All forms of medical waste must be stored and disposed of according to W. Va. Code §20-5J-1, et seq. and Department of Health Legislative Rule, “Infectious Medical Waste,” 64CSR56.
4.12. Operational Policies and Procedures. -- EMS agencies shall maintain current written operational policies and procedures which are subject to inspection by the Secretary. Required policies and procedures include, but are not limited to, operation and maintenance of services; equipment and facilities management; health and safety practices for personnel; patient safety; a medication management plan compliant with federal and state requirements; infection control practices; anti-harassment; vehicle operations; and personnel management. Additional aeromedical agency requirements include: a contemporaneous flight following plan used in all phases of flight operations; a notification policy for requesting agencies and facilities which includes estimated time of arrival, any changes in time or flight status; a routinely drilled post accident/incident plan; a policy to reduce “helicopter shopping” including appropriate pre-flight screening and cooperation with other aeromedical providers; and a customer education program addressing patient preparation, landing zone management, and customer safety around the aircraft and equipment.
4.13. Records. -- EMS agencies are responsible for the preparation and maintenance of records. All records are subject to inspection by the Secretary. Records must be stored in a manner as to provide reasonable safety from water and fire damage and from disclosure to persons other than those authorized by law. Secure storage must be provided for all medical records. EMS agencies shall comply with data collection and reporting requirements in subsection 3.2. of this rule. The EMS agency shall prepare and maintain for a period of not less than seven years the following records:
4.13.1. Personnel records documenting training, qualifications, and licensure for positions held; and
4.13.2. Records for each EMS vehicle including vehicle registration records, records of safety inspections, repair, and crash incident reports as specified by the Secretary;
4.14. Insurance. -- Each EMS agency shall have in effect, maintain, and furnish proof of errors and omissions insurance as required by W. Va. Code §16-4C-16, and current insurance policies for all EMS vehicles operated by the agency.
4.15. Non-Discrimination. -- EMS agencies shall maintain a written policy to prohibit the refusal of emergency response, treatment, and transportation of patients to the nearest appropriate facility on incidents with potentially critical illness or injury, regardless of the patient’s age, gender, ethnicity, or ability to pay for services.
4.16. Public Access. -- An EMS agency shall provide a publicly listed telephone number to receive requests for service from the general public within its regular operating area.
4.16.1. The primary emergency number shall be 9-1-1.
4.16.2. Secondary telephone numbers may be provided for the provision of non-emergency services.
4.16.3. An EMS agency that, according to written policy, does not respond to calls from the general public and responds only to calls from a defined, closed population, such as the population of an institution, an industrial plant, facility, or a university, is not required to provide a publicly listed telephone number. These agencies shall provide a telephone number that is known to the defined population served and is answered during all periods when that population may require service.
4.17. Availability. -- EMS agencies shall ensure that service for which they are licensed is available to the public or population served within their regular operating area on a 24-hour continuous basis either by providing the service themselves or by written agreement with another licensed EMS agency.
4.18. Communications. -- Communication systems must comply with state and federal rules, regulations, policies, and protocols.
4.19. Performance Improvement. -- EMS agencies shall comply with the minimum performance improvement program established by the Secretary.
4.20. Standards. -- In addition to the requirements set forth in this rule, the Secretary will score the EMS agency or proposed EMS agency according to the standards contained in subsections 4.21. through 4.31. Certain standards, as determined by the Secretary, may not apply to an EMS agency depending on the type of service provided or population served.
4.21. Level of Service. -- EMS agencies that have been licensed by the Secretary are subject to a rating system based upon the following evaluations and point scores:
4.21.1. ALS staffed and equipped EMS vehicles are dispatched on all emergency requests for service, or a community paramedic dispatch program or, a tiered response is dispatched based on criteria from an OEMS recognized Emergency Medical Dispatch program: 15 points.
4.21.2. ALS services are available only on a part-time basis: 10 points.
4.21.3. BLS services only are available: five points.
4.22. Medical Accountability.
4.22.1. Offline Medical Direction.
4.22.1.a. The agency medical director(s) has a written contract with the EMS agency outlining duties and responsibilities and is actively involved with the agency through direct participation in activities, including, but not limited to, oversight of training, skills maintenance, and recertification as established by OEMS and the MPCC; clinical performance evaluation, and the performance improvement process as evidenced by documented participation in quarterly, or more frequent, meetings with agency officials and personnel: 10 points; or
4.22.1.b. The medical director(s) has a written contract with the EMS agency outlining duties and responsibilities with minimal evidence of active involvement with the agency: five points.
4.22.2. Performance Improvement. -- The EMS agency demonstrates commitment to performance improvement as evidenced by activities substantially exceeding state minimum requirements described in subsection 4.19. of this rule: 15 points.
4.23. Rapid Response.
4.23.1. The EMS agency has a rapid response program which routinely places trained and equipped personnel on the scene of potential life-threatening emergencies prior to the arrival of an ambulance, in accordance with policies and guidelines established by OEMS: five points; or
4.23.2. The EMS agency has formalized rapid response capabilities provided irregularly or is not available in all parts of the service area: two points.
4.24. Public Education and Information.
4.24.1. The EMS agency has community presence which is documented through provision of public education and community service programs for the covered population. The EMS agency offers the activities quarterly, or more often, and actively participates with outside organizations and groups: five points; or
4.24.2. The EMS agency provides limited or intermittent education or service programs within the community: one point.
4.25. Disaster Capability.
4.25.1. Disaster Plan. The EMS agency has a current, written all-hazards plan for disaster response which is integrated with adjacent providers and emergency management officials. The plan is compliant with current federal and state emergency planning and operational standards: five points.
4.25.2. Disaster Drills. The EMS agency conducts, or participates in, disaster drills with adjacent EMS agencies, other emergency response entities, and county emergency management agencies at least annually: five points.
4.26. Mutual Aid.
4.26.1. The EMS agency maintains current written mutual aid agreements addressing all aspects of reciprocal service provision with all adjacent EMS agencies or operates under written mutual aid guidelines established by the Local System: five points.
4.26.2. The EMS agency has limited-scope mutual aid agreements or does not have them with all adjacent EMS agencies: one point.
4.27. Personnel.
4.27.1. Job Descriptions. -- The EMS agency maintains current written job descriptions for all positions within the agency: three points.
4.27.2. Recruitment. -- The EMS agency uses a formal, documented recruitment program to actively recruit new personnel: three points.
4.27.3. Personnel Screening. -- The EMS agency screens and selects applicants with a formal, documented, objective process: three points.
4.27.4. Orientation. -- The EMS agency uses a formal orientation process with documented completion of specific stated objectives. Documentation of completion is maintained in each personnel file: three points.
4.27.5. Retention. -- The EMS agency uses a formal, documented retention program to aid in retention of qualified personnel: three points.
4.28. Education and Training.
4.28.1. Personnel Education.
4.28.1.a. The EMS agency provides education for all personnel levels within the agency. Educational offerings exceed minimum recertification requirements and include at least one program leading to original certification: 15 points;
4.28.1.b. The EMS agency provides, in-house or makes available, training activities meeting all minimum recertification requirements for all personnel levels within the agency: 10 points; or
4.28.1.c. The EMS agency provides some in-house training activities meeting some recertification requirements for personnel: five points.
4.28.2. Training Officer’s Program. The EMS agency participates fully in the state-approved training officers’ program with a qualified designated agency training officer and offers in-house continuing education programs a minimum of two times per year: 10 points.
4.29. Financial. -- The following shall be prepared according to generally accepted accounting practices:
4.29.1. Budget. -- The EMS agency has an approved, written operating and capital expenditures budget which includes projected income and expenses, actual income and expenses, and an accounting of budget variances. Budget reports are provided quarterly, at a minimum, to the agency’s governing body or ownership, management personnel, and other significant stakeholders: five points.
4.29.2. Financial Stability. -- The EMS agency is financially viable as evidenced by:
4.29.1.a. A full financial audit or quarterly articulated financial statements provided by an independent accounting firm during the license period: 10 points;
4.29.1.b. A financial review conducted by an independent entity within the license period: five points; and
4.29.1.c. Interim articulated financial statements: two points.
4.29.2. Financial Responsibility. -- The EMS agency has formally designated individuals with financial responsibility. Individuals with financial responsibility shall be appropriately insured or bonded: five points.
4.30. Facilities and Equipment.
4.30.1. Facilities Maintenance Program. -- The EMS agency uses a documented, comprehensive program of routine inspection and preventive maintenance for all agency facilities: five points.
4.30.2. Vehicle Maintenance Program. -- The EMS agency uses a documented, comprehensive program of routine inspection and preventive maintenance performed by qualified personnel for all EMS vehicles: five points.
4.30.3. Medical Equipment. -- The EMS agency uses a documented, comprehensive program of routine inspection and preventive maintenance performed by qualified personnel for all medical equipment: five points.
4.31. Accountability and Stability.
4.31.1. Government Support and Recognition.
4.31.1.a. The responsible county commission statutory ambulance authority or other statutory entity charged with the responsibility for providing the service formally recognizes the agency as part of the Local System and provides sufficient resources to support agency operations: five points; or
4.31.1.b. The agency is formally recognized by the responsible county commission, statutory ambulance authority, or other statutory entity charged with the responsibility for providing the service as part of the Local System but receives minimal support: two points.
4.31.2. Organization and Management:
4.31.2.a. The agency is formally and legally organized with clear lines of managerial authority and responsibility as evidenced by an agency charter or articles of incorporation, current written by-laws, current registration with the Secretary of State, current organizational charts, policies, etc.: five points.
4.31.2.b. Management Education -- EMS agency management personnel have documented education in EMS management practices and procedures. Continuing education in management practice is required and participation of current management personnel is documented: five points.
4.32. The Secretary may issue a license according to W. Va. Code §16-4C-6a, provided the information contained in the application is complete and correct, and the applicant is determined eligible for licensure by the Secretary in accordance with this rule.
4.33. The Secretary will notify the EMS agency in writing of the findings of the inspection and, if the inspection is approved, issue an EMS agency license within 60 days of receipt of application and completion of agency and vehicle inspections.
4.34. An EMS agency license will include the following information:
4.34.1. The name and address of the EMS agency;
4.34.2. The name of the official representative of the EMS agency;
4.34.3. All levels of service for which the agency is licensed; and
4.34.4. The issue and expiration dates of the license.
4.35. The standards ratings and renewal periods are determined as follows:
4.35.1. “A” rating -- a score of 90 percent or higher of applicable points. A four-year license shall be issued.
4.35.2. “B” rating -- a score of between 80 percent and 89 percent of applicable points. A three- year license may be issued.
4.35.3. “C” rating -- a score of between 70 percent and 79 percent of applicable points. A two-year license may be issued.
4.35.4. “F” rating -- a score of less than 70 percent of applicable points. No license shall be issued.
4.35.5. “Provisional” rating -- a score of greater than 70 percent of applicable points earned by a new agency. A six- month license may be issued; and
4.35.6. Extension of license -- The Secretary may extend, as necessary, an agency license for a period of not greater than six months from the date of expiration.
4.36. Review of Preliminary Agency Inspection Findings.
4.36.1. When a preliminary inspection report is completed, the OEMS inspector and the agency official representative will meet to discuss the findings. The agency official representative must either concur with the findings or present documentation or facts disputing any portion of the preliminary inspection report.
4.36.2. In the case of disputed findings the OEMS inspector may concur with the information provided and revise the findings appropriately or refer the preliminary inspection report, along with all documentation presented by the official representative, to the Director of OEMS for review.
4.36.2.a. The Director may either uphold the inspector’s findings or modify the findings based on the facts presented.
4.36.2.b. The Director will communicate his or her action to the agency principal official within 10 days of receiving the preliminary inspection report and associated documentation.
4.37. Plan of Improvement.
4.37.1. An EMS agency may submit a plan of improvement to improve the rating upon receipt of a final license inspection report.
4.37.2. A plan of improvement shall only be applicable to the standards section of a final license inspection report.
4.37.3. The agency has 10 working days from receipt of the final license inspection report to notify OEMS of intent to submit a plan of improvement.
4.37.4. The proposed plan of improvement will be submitted within 15 days of initial notification.
4.37.5. Plans of improvement must include:
4.37.5.a. Standards to be addressed;
4.37.5.b. Specific improvement strategies to be implemented;
4.37.5.c. The desired outcome of the proposed improvements; and
4.37.5.d. A proposed implementation period.
4.37.6. The Secretary has 10 working days to approve or reject the plan.
4.37.7. The Secretary must specify the areas of the plan he or she rejected.
4.37.8. In the event the plan is rejected, the agency may submit a revised plan within 10 working days of receipt of notice of the plan’s rejection.
4.37.9. Once an improvement plan is approved, the agency will complete the proposed improvements within the agency’s specified implementation period.
4.37.10. Upon completion of the improvement period, OEMS will re-inspect the specific standards proposed for improvement.
4.37.11. If, as a result of re-inspection, standards ratings improve, the Secretary will issue a new license reflecting the change.
4.37.12. If, as a result of re-inspection, there is no improvement, the original license rating will stand without opportunity for further review until the next inspection period.
4.38. Alternative Licensing Method.
4.38.1. In lieu of the requirements set forth in this section, the Secretary may recognize an agency evaluation by a nationally recognized EMS agency accrediting body as meeting state licensing requirements; Provided: That the nationally recognized EMS agency meets or exceeds state requirements, as determined by the Secretary;
4.38.2. An OEMS inspector will accompany accreditation officials during the site visit to the EMS agency;
4.38.3. The accrediting body will provide a copy of the findings of the accreditation site visit directly to OEMS; and
4.38.4. Agencies seeking alternative licensing are subject to the fees set forth in subsection 4.39. of this rule.
4.39. Agency Fees. -- Non-refundable fees for agency license and vehicle permits are due upon receipt of the invoice. Fees are:
4.39.1. Original agency license application, $500.
4.39.2. Renewal fee for each agency licensing period, $300, except that no additional fee shall be charged to provisional licensees.
4.39.3. Yearly EMS vehicle permit, $200 per vehicle. Non-transporting vehicles are exempt from this fee.
4.39.4. Agency license modification, including revision based upon a plan of improvement, $100. A change of official representative, medical director, training officer, postal address, or other contact information is exempt from this fee.
4.39.5. Fees must be paid to the West Virginia Department of Health in a manner specified by the Secretary.
W. Va. Code R. § 64-48-5 Vehicles
5.1. General Requirements.
5.1.1. Unless specified differently herein, ground ambulances must meet applicable U.S. Government Services Agency or subsequent federally approved specifications at the time of the vehicle’s manufacture.
5.1.2. Each EMS vehicle must be maintained in good repair and operating condition and shall have a current state inspection if required by the state issuing the vehicle license.
5.1.3. EMS vehicles may not be maintained or operated except by a licensed EMS agency. United States government EMS vehicles are exempt from this requirement.
5.1.4. The EMS agency may exercise emergency operating privileges, including the use of audible and visible emergency warning devices, only during response to the location of an emergency call, while at the location, and during transportation of a patient. Operation of these devices must be in compliance with W. Va. Code §17C-2-5.
5.1.5. All operators of ground EMS vehicles shall meet the requirements of paragraphs 6.7.1.i, 6.7.1.j., and 6.7.1.k. of this rule, in addition to minimum standards established for the individual’s level of licensure.
5.1.6. Sanitation. -- The following requirements for sanitary conditions apply to all EMS vehicles:
5.1.6.a. The interior of EMS vehicles, including all storage areas, linens, equipment, and supplies must be clean and sanitary;
5.1.6.b. Freshly laundered linen or disposable sheets and pillow cases must be used during the transporting of patients and shall be changed after each use;
5.1.6.c. Pillows and mattresses used in EMS vehicles must be clean and in good repair;
5.1.6.d. Plastic bags, covered containers, or compartments must be used for the storage of soiled supplies and used disposable items. Biohazard bags clearly marked with the biohazard symbol shall be used for infectious waste;
5.1.6.e. Exterior surfaces must be clean;
5.1.6.f. Blankets used in EMS vehicles must be clean and replaced after use;
5.1.6.g. Single use devices or supplies must be stored in a sterile manner and appropriately disposed of after use. Reusable items must be sterilized in accordance with current medical practices;
5.1.6.h. Waterless antibacterial hand cleaner must be available on each EMS vehicle;
5.1.6.i. A bleach or disinfectant solution, approved by the United States Centers for Disease Control, must be available on EMS vehicles for cleaning purposes;
5.1.6.j. A disposal container for used sharp items must be available on each EMS vehicle; and
5.1.6.k. The EMS agency shall ensure that, when EMS vehicles are used to transport a patient with an infectious disease, all interior contact surfaces must be cleaned and disinfected prior to being occupied by another patient.
5.1.7. Equipment and Supplies. -- The EMS agency shall ensure that each EMS vehicle has all required equipment and supplies necessary for the level of service being provided while en route to an incident, at the scene, and during transport of a patient.
5.1.7.a. The EMS agency shall ensure that vehicle equipment is maintained in good working operation at all times.
5.1.7.b. The EMS agency shall ensure that supplies are restocked as necessary to maintain the minimum requirements during each response.
5.1.8. The operator’s compartment must accommodate safe operation of the EMS vehicle.
5.1.9. Safety belts must be available and operational for all seat positions in EMS vehicles; no shoulder harness-type restraints are allowed on side-facing seat positions.
5.1.10. All EMS vehicles must have a lockable storage compartment for medications in accordance with federal Drug Enforcement Administration regulations.
5.1.11. Exterior Vehicle Marking Requirements:
5.1.11.a. All ground ambulances purchased on or after July 1, 2018, shall be consistent with 2017 reflective marking standards published by the Commission on Accreditation of Ambulance Services (CAAS).
5.1.11.b. An EMS vehicle may only be lettered with the terms “Paramedic,” “Advanced Life Support,” “Critical Care Transport,” or similar service-level designations when the vehicle is licensed by OEMS for that level of service.
5.1.11.c. The public access emergency telephone number 9-1-1 must be displayed on the ambulance. SMPMT and non-public access EMS vehicles may display a different number.
5.1.11.d. Emergency warning lights must be visible from all four sides of the vehicle.
5.1.11.e. One or more audible warning devices must be installed to provide adequate audible warning.
5.1.11.f. All EMS vehicles must have communications equipment which provides voice communication between the vehicle and its dispatch center, other EMS vehicles of the same EMS agency, and medical command. Communication equipment must be operational and compatible with the EMS communication system and comply with state and federal rules, regulations, policies, and protocols.
5.1.12. Inspection. -- All EMS vehicles are subject to inspection by the Secretary for compliance with this rule at any time and without prior notification. This inspection is in addition to other inspections required for EMS vehicles by federal, state, or local law, rules, and regulations.
5.2. Non-Transporting EMS Vehicles.
5.2.1. The EMS agency may use non-transporting EMS vehicles intended for the immediate movement of personnel and equipment to the location of an incident. Personally owned vehicles (POVs) may be used for similar purposes and are exempt from this rule, provided that they are authorized by the official representative of the licensed EMS agency. POVs and their operators are subject to requirements of the Division of Motor Vehicles and OEMS Emergency Vehicle Permit program.
5.2.2. Non-transporting EMS vehicles may not be used for the transportation of patients, except in the case of a disaster.
5.3. Transporting EMS Vehicles, excluding SMPMT vehicles, must meet the following requirements:
5.3.1. Transporting EMS vehicles are used for the delivery of basic or advanced life support or critical care transport. The equipment, supplies, and staffing required are dependent upon the level of service being provided on a particular incident as specified in the Medical Direction System’s policy, protocols, and scope of practice. Transporting EMS vehicles may be used to deliver services at the level at which they are certified or below. Transporting EMS vehicles may not deliver services at levels exceeding that at which they are certified.
5.3.2. Staffing is dependent upon the level of service being provided on a particular incident as specified in the Medical Direction system’s policy, protocols, and scope of practice and appropriate staff shall be onboard at all times during patient treatment and transport:
5.3.2.a. BLS -- at a minimum a licensed EMVO and EMT;
5.3.2.b. ALS -- at a minimum a licensed EMVO and AEMT or Paramedic, provided that individual protocols may specify alternative staffing as specified by the OEMS Medical Direction System.
5.3.2.c. Critical care transport -- at a minimum a licensed EMVO and two MCCPs, or one MCCP and one MCCN as required by treatment guidelines and policies specific to the individual patient’s care requirements as specified by the OEMS Medical Direction System. Hospital-based specialty medical personnel may replace one of the licensed personnel for the purpose of providing a higher level of care required by a particular patient.
5.3.2.d. The minimum equipment and supplies required are dependent upon the level of service being provided on a particular incident as specified in OEMS’s policy, protocols, and scope of practice and shall be onboard at the time of response and during patient treatment and transport.
5.4. Air Ambulance. -- There shall be two categories, one for rotary wing aircraft and one for fixed wing aircraft. All EMS agencies engaging in air ambulance service under this rule shall operate in accordance with Federal Aviation Administration rules, 14 CFR Part 135.
5.4.1. Rotary Winged Aircraft.
5.4.1.a. A rotary winged aircraft is intended for response to the location of an EMS incident or for inter-facility transportation of patients.
5.4.1.b. The aircraft patient compartment must accommodate at least two medical personnel who must have access to the patient’s head and upper body from a seat-belted position while in flight and at least one stretcher patient; and:
5.4.1.b.1. Provide necessary space to ensure that the patient’s airway is maintained and to provide adequate ventilator support from a secured, seat-belted position of medical personnel; and
5.4.1.b.2. Be configured to allow medical personnel to have full-body patient view and access, and access to equipment and supplies to initiate basic, advanced, and critical care life support emergency procedures while in flight.
5.4.1.c. The cockpit must be configured so that flight controls and pilot communications equipment are protected from intended or accidental interference by the patient or medical equipment and supplies.
5.4.1.d. Door openings must accommodate the loading of a stretcher without compromising the stability of the patient or the functioning of monitoring systems, intravenous lines, and manual or mechanical ventilation;
5.4.1.e. A visible warning device may be installed on the underside of the aircraft to provide adequate day and night emergency warning. An audible warning device may be installed to provide adequate emergency warning and external voice communications;
5.4.1.f. Patient area lighting may not interfere with the safe operation of the aircraft; and
5.4.1.g. The aircraft must have communications equipment which provides voice communications between the aircraft and its base of operation, between the aircraft and other EMS aircraft of the same EMS agency for which this requirement applies and between the aircraft and a Medical Command Center. The communications equipment must be operational and compatible with the communications system and comply with state and federal rules, regulations, policies, and protocols.
5.5. An EMS Agency may use rotary winged aircraft for the delivery of critical care transport. The equipment, supplies, and staffing required are dependent upon the level of service being provided on a particular incident as specified in the Medical Direction System’s policy, protocols, guidelines, and scope of practice.
5.5.1. Staffing requirements are determined by the level of service being provided on a particular incident as specified in the Medical Direction System’s policy, protocols, and scope of practice. The following must be onboard at all times during patient treatment and transport:
5.5.1.a. Critical care transport -- a minimum of a pilot-in-command and one MCCP and one MCCN. Hospital-based specialty medical personnel may replace one of the licensed EMS personnel for the purposes of providing a higher level of care required by a particular patient;
5.5.1.b. The minimum equipment and supplies as defined by OEMS policy are determined by the level of service being provided on a particular incident and must be onboard at the time of response and during patient treatment and transport.
5.5.2. Fixed Wing Aircraft.
5.5.2.a. A fixed wing aircraft is primarily intended for extended air transport between medical facilities within the state or across state boundaries.
5.5.2.b. The aircraft patient compartment must accommodate at least two medical personnel who must have access to the patient’s head and upper body from a seat-belted position while in flight and at least one stretcher patient and:
5.5.2.b.1. Provide necessary space to ensure that the patient’s airway is maintained and to provide adequate ventilator support from a secured, seat-belted position of medical personnel.
5.5.2.b.2. Be configured to allow medical personnel to have full-body patient view and access, and access to equipment and supplies to initiate basic, advanced, and critical care life support emergency procedures.
5.5.2.c. The cockpit must be configured so that flight controls and pilot communications equipment are protected from intended or accidental interference by the patient or medical equipment and supplies.
5.5.2.d. Door openings must accommodate the loading of a stretcher without compromising the stability of the patient or the functioning of monitoring systems, intravenous lines, and manual or mechanical ventilation.
5.5.2.e. Patient area lighting may not interfere with the safe operation of the aircraft.
5.5.2.f. All aircraft must have communications equipment which provides voice communications between the aircraft and its base of operation and voice communications between the aircraft and other aircraft of the same EMS agency for which this requirement applies and between the aircraft and its Medical Command Center. The communications equipment must be operational and compatible with the communications system and comply with state and federal rules, regulations, policies, and protocols.
5.5.2.g. Staffing is determined by the level of service being provided on a particular incident as specified by Medical Direction System’s policy, protocols, and scope of practice and appropriate staff shall be onboard at all times during patient treatment and transport:
5.5.2.g.1. BLS. -- a minimum of a pilot-in-command and an EMT;
5.5.2.g.2. ALS. -- a minimum of a pilot-in-command and Paramedic, provided that individual protocols may specify alternative staffing as specified by the OEMS Medical Direction System;
5.5.2.g.3. Critical care transport. -- a minimum of a pilot-in-command and two MCCPs, or one MCCP and one MCCN based on treatment guidelines and policies as specified by the OEMS Medical Direction System. Hospital-based specialty medical personnel may replace one of the licensed EMS personnel for the purpose of providing a higher level of care required by a particular patient.
5.5.2.g.4. The minimum equipment and supplies as defined by OEMS policy are determined by the level of service being provided on a particular incident and must be onboard at the time of response and during patient treatment and transport.
5.6. SMPMT vehicles:
5.6.1. A SMPMT vehicle is used to transport patients, with a medical history and no apparent immediate need for any level of medical supervision, to and from scheduled medical appointments.
5.6.2. SMPMT vehicles must be maintained in good repair and operating condition and have a current state inspection, if required by the state issuing the vehicle license.
5.6.3. The interior of SMPMT vehicles, including all storage areas, equipment, and supplies must be clean and sanitary;
5.6.4. Safety belts must be available and operational for all seat positions in SMPMT vehicles.
5.6.5. SMPMT vehicles shall not be equipped with any form of stretcher.
5.6.6. An EMS agency may not use a SMPMT vehicle for delivery of basic or advanced life support, except in the case of a disaster.
5.6.7. SMPMT vehicle specifications include the following:
5.6.7.a. The vehicle may be a commercial passenger van or specially modified passenger van. Passenger sedans, limousines, recreational vehicles, and sport utility vehicles with fewer than three passenger doors and a wheelbase of less than 100 inches are not permitted.
5.6.7.b. The name of the agency must appear on both sides and the back of the vehicle in four inch minimum-height letters. Clearly readable logos or emblems are acceptable.
5.6.7.c. A contact phone number, other than 9-1-1, may appear on the vehicle.
5.6.7.d. Neither the word ambulance nor other emergency designation must appear on the vehicle; Provided: That such appearing as part of the name of the agency shall be exempt.
5.6.7.e. A Star of Life is not permitted on the vehicle.
5.6.8. Equipment and supplies for SMPMT vehicles include:
5.6.8.a. Communications equipment which provides voice communications between the vehicle and its dispatch center; and
5.6.8.b. The minimum equipment and supplies required are as specified in OEMS’s policy.
5.6.9. All SMPMT vehicles must be inspected by OEMS.
5.6.10. SMPMT vehicles must be staffed with one person who shall be licensed, at a minimum, as an EMVO pursuant to subsection 6.7. of this rule.
W. Va. Code R. § 64-48-6 Personnel
6.1. Minimum Eligibility Requirements. -- An applicant for certification, and a license holder, shall:
6.1.1. Be at least 18 years of age. EMRs and EMTs must be at least 16 years of age or older. Persons under 18 years of age may not serve as primary patient care attendant or driver of any EMS vehicle;
6.1.2. Be neat and clean in appearance;
6.1.3. Possess the ability to speak, read, comprehend, and write the English language;
6.1.4. Possess the physical and mental abilities to independently perform all relevant EMS skills including, but not limited to, performing physical assessments, providing appropriate patient care, calculating medication dosages, communicating effectively, and documenting patient care activities;
6.1.5. Possess the manual dexterity and fine motor skills required to perform all patient care functions;
6.1.6. Possess the ability to bend, stoop, crawl, and walk on uneven surfaces; and
6.1.7. Meet minimum vision requirements to operate a motor vehicle in this state.
6.2. Standards of Conduct.
6.2.1. Licensed personnel shall comply with all applicable rules, policies, and procedures implemented by OEMS.
6.2.2. Licensed personnel shall comply with all federal, state, and local laws.
6.2.3. Licensed personnel may not be impaired by legal or illegal drugs or intoxicating substances while on duty, when responding to or operating at incidents, and when engaged in any patient care activities.
6.2.4. Licensed personnel may not misrepresent themselves as authorized to perform a level of care for which they are not currently licensed or authorized nor provide that care. However, students currently enrolled in an approved education program when properly authorized and supervised may provide care for which they are trained.
6.2.5. Licensed personnel may not obtain, aid, or encourage another person or entity to obtain agency licensure, vehicle permits, licensure, certification, endorsement, or designation through fraud, deceit, forgery, or other misrepresentation or falsification of information.
6.2.6. Licensed personnel may not make false statements or misrepresentations, file false credentials, or conceal or omit information from OEMS regarding an application for agency licensure, vehicle permitting, licensure, certification, endorsement, or investigation.
6.2.7. Licensed personnel may not alter or change the appearance or wording of any license, permit, certificate, endorsement, designation, patient care record, or other official documents for the purpose of fraud, deceit, forgery, or other deliberate misrepresentation or falsification of information.
6.2.8. Licensed personnel may not possess, remove, use, or administer any controlled substances, medications, medication delivery devices, or other regulated medical devices from any EMS agency, EMS vehicle, health care facility, academic institution, or other location without documented authorization.
6.2.9. Licensed personnel may not discriminate in the provision of EMS based on race, gender, religion, age, national origin, medical condition, or any other reason prohibited by law.
6.2.10. Licensed personnel may not engage in illegal harassment of patients or coworkers.
6.2.11. Licensed personnel may not disclose medical information regarding any patient without that patient’s consent, except that information required for continuation of treatment, for payment purposes or operations, including quality review investigations and training, or by mandate of a legally issued subpoena or lawful court order.
6.2.12. Licensed personnel shall disclose illegal, unethical acts and conduct of EMS personnel or agencies to OEMS.
6.2.13. Licensed personnel shall possess state issued credentials while on duty, when responding to or operating at EMS incidents, and when engaged in any patient care activities.
6.2.14. Licensed personnel shall report to OEMS and to their affiliated EMS agencies within 10 days any arrest, indictment, misdemeanor or felony conviction, or revocation, suspension, or other disciplinary sanction of a certificate or other privilege to practice any health care profession or occupation in any state or exclusion from federal reimbursement programs.
6.3. Certification Requirements. -- In addition to the requirements of subsection 6.1. of this rule, an applicant for an EMD, EMR, EMT, AEMT, or Paramedic, license shall:
6.3.1. Apply in a format prescribed by the Secretary;
6.3.2. Submit the appropriate fees as described in subsections 6.8. and 6.9. of this rule;
6.3.3. Continuously meet all requirements for EMS personnel as described in this rule;
6.3.4. Disclose any limitations or exclusions by an EMS agency, State Medical Director, or any other health care profession certification or licensing authority in any state. The limitations or exclusions may be considered by the Secretary prior to issuance of licensure in West Virginia;
6.3.5. Possess valid CPR certification prescribed by the Secretary;
6.3.6. Submit to a criminal history check and the results of the criminal background check do not indicate that the applicant:
6.3.6.a. Demonstrates an inability or unwillingness to comply with state laws, rules, procedures, etc.; or
6.3.6.b. Poses a threat to public safety, health, or welfare.
6.3.7. Successfully complete an education program appropriate for the level of licensure as prescribed by the Secretary;
6.3.8. Successfully complete a cognitive and skills examination appropriate for the level of licensure as prescribed by the Secretary; and
6.3.9. Meet other requirements established by the Secretary.
6.4. Recertification Requirements. -- An applicant for an EMD, EMR, EMT, AEMT, or Paramedic, license renewal shall:
6.4.1. Apply for recertification during the last year of his or her license period, but no later than 90 days prior to the end of the applicant’s license period;
6.4.2. Apply in a format prescribed by the Secretary;
6.4.3. Submit the appropriate fees as described in subsections 6.8. and 6.9. of this rule;
6.4.4. Continuously meet all requirements for personnel as described in this rule;
6.4.5. Disclose any limitations or exclusions by an EMS agency, State Medical Director, or any other health care profession certification or licensing authority in any state. The limitations or exclusions may be considered by the Secretary prior to issuance of license renewal in West Virginia;
6.4.6. Possess valid a CPR certification prescribed by the Secretary;
6.4.7. Complete refresher and continuing medical education prescribed by the Secretary appropriate for the level of licensure;
6.4.8. Demonstrate continued competency via one of the following methods:
6.4.8.a. The applicant shall maintain continuous National Registry certification, or
6.4.8.b. Successfully complete any NREMT cognitive and skills examinations prescribed by the Secretary appropriate for the level of licensure; and
6.4.9. Meet other requirements established by the Secretary.
6.5. Credential Transfer Requirements -- The Secretary may grant licensure, including a temporary license pursuant to subsection 6.13. of this rule, to an individual certified as an EMD, EMR, EMT, AEMT, Paramedic, or equivalent levels, in another U. S. state or territory provided that the individual:
6.5.1. Meets all requirements for the licensure level for which he or she is applying as described in this rule including the submission of the appropriate fee as provided in subsection 6.8. of this rule;
6.5.2. Demonstrates current equivalent education and certification or licensure in another U.S. state or territory, the U.S. military, or a federal agency;
6.5.3. Submits to a criminal history background check and the results of the criminal background check do not indicate that the applicant:
6.5.3.a. Demonstrates an inability or unwillingness to comply with state laws, rules, procedures, etc.; or
6.5.3.b. Poses a threat to public safety, health, or welfare.
6.5.4. Demonstrates competency via one of the following methods:
6.5.4.a. The applicant possesses current National Registry certification at the appropriate level;
6.5.4.b. Previous National Registry certification at the appropriate level with continuous, current, state certification or license with 120 days or more remaining; or
6.5.4.c. Possess a valid state certification or license with 120 days or more remaining, provided that the applicant may be required to successfully complete state cognitive and skills examinations prescribed by the Secretary.
6.5.5. Completes training and education, including West Virginia protocols and scope of practice, at the appropriate level within 120 days;
6.5.6. Meets other requirements established by the Secretary; and
6.5.7. Discloses any limitations or exclusions by an EMS agency, State Medical Director, or any other health care profession certification or licensing authority in any state. The limitations or exclusions may be considered by the Director or Secretary prior to issuance of licensure.
6.6. Certification Period. -- Licensure as an EMD, EMVO, EMR, EMT, AEMT, or Paramedic is valid for a period of two years with expiration dates determined by the Secretary.
6.7. EMVO.
6.7.1. Licensure Requirements. -- The applicant shall:
6.7.1.a. Apply in a format prescribed by the Secretary;
6.7.1.b. Submit the appropriate fees as described in subsection 6.8. of this rule;
6.7.1.c. Be 18 years of age or older;
6.7.1.d. Possess a valid CPR certification prescribed by the Secretary;
6.7.1.e. Successfully complete hazardous materials awareness training meeting Department of Labor, Occupational Safety and Health Administration (OSHA) 1910.120 requirements or greater;
6.7.1.f. Successfully complete first aid training meeting United States Department of Labor, OSHA 1910.266, appendix B, requirements or greater;
6.7.1.g. Submit to a criminal history background check and the results of the criminal background check do not indicate that the applicant:
6.7.1.g.1. Demonstrates an inability or unwillingness to comply with state laws, rules, procedures, etc.; or
6.7.1.g.2. Poses a threat to public safety, health, or welfare.
6.7.1.h. Disclose any limitations or exclusions by an EMS agency, State Medical Director, or any other health care profession certification or licensing authority in any state. The limitations or exclusions may be considered by the Secretary prior to issuance of license credentials;
6.7.1.i. Possess and maintain a valid driver’s license;
6.7.1.j. Not have been convicted of driving under the influence of alcohol or drugs, reckless driving, or other vehicular violation causing bodily injury or death within the two years prior to submitting an application; and
6.7.1.k. Successfully complete an emergency vehicle operator course approved by the Secretary.
6.7.2. Recertification requirements. -- The applicant shall:
6.7.2.a. Apply in a format prescribed by the Secretary;
6.7.2.b. Submit the appropriate fees as described in subsection 6.8. of this rule;
6.7.2.c. Possess valid CPR certification prescribed by the Secretary;
6.7.2.d. Successfully complete hazardous materials awareness training meeting U.S. Department of Labor OSHA 1910.120 requirements or greater;
6.7.2.e. Possess valid first aid certification meeting U.S. Department of Labor OSHA 1910.266, appendix B requirements or greater; and
6.7.2.f. Possess and maintain a valid driver’s license.
6.8. Fees. An applicant for EMVO, EMR, EMT, Paramedic, to be deposited in the Emergency Medical Services Agency Licensure Fund, established by the provisions of W. Va. Code §16-4C-6b, shall pay the following non-refundable certification fees:
6.8.1. Initial certification via National Registry or state examination: $37.50;
6.8.2. Recertification via National Registry maintenance or state process: $18.75;
6.8.3. Legal recognition: $100;
6.8.4. Reinstatement:
6.8.4.a. License expired beyond two years: $100;
6.8.4.b. License suspended or otherwise expired as a result of actions taken per subsection 7.5. of this rule: $100.
6.8.5. National Criminal Background Check: $47.50.
6.9. Fees for EMD applicants:
6.9.1. Initial application: $25.
6.9.2. Recertification: $25.
6.10. Fee for license modification: $10.
6.11. Card or license replacement: $5.
6.12. Late (within 90 days of expiration date) recertification application: additional $25.
6.13. Temporary Licensure.
6.13.1. Upon application for licensure pursuant to subsection 6.5. of this rule, the Secretary may issue a temporary EMS personnel license to an applicant, with or without examination, who submits to a preliminary criminal history background check and the results of the preliminary criminal background check do not indicate that the applicant:
6.13.1.a. Demonstrates an inability or unwillingness to comply with state laws, rules, procedures, etc.; or
6.13.1.b. Poses a threat to public safety, health, or welfare, when he or she finds that issuance to be in the public interest.
6.13.2. Unless suspended or revoked, a temporary license shall be valid initially for a period not exceeding 120 days and may not be renewed unless the Secretary finds the renewal to be in the public interest.
6.14. AEMT Certification. In the event that the National Registry of Emergency Medical Technicians ceases to recertify individuals with an AEMT certification, the Secretary will either:
6.14.1. Terminate the AEMT certification. Provided: That persons who are certified as an AEMT at the time of the termination of the AEMT certification may continue to provide services pursuant to their certification until the expiration of their certification; or
6.14.2. Establish state certification standards to replace the National EMS Certification.
W. Va. Code R. § 64-48-7 Investigative/Disciplinary
7.1. The Secretary may initiate investigations on his or her own motion, and upon the written complaint of any person, cause investigations to be conducted to determine if disciplinary action is called for, and impose the sanctions upon EMS personnel as described in W. Va. Code §16-4C-9. Reasons for such actions include, but are not limited to:
7.1.1. Failure to comply with any requirements of subsections 6.1. or 6.2. of this rule;
7.1.2. Incompetent practice while providing EMS;
7.1.3. Abuse or abandonment of a patient;
7.1.4. Willful preparation or filing of false medical reports or records, or the inducement of other persons to do so;
7.1.5. Destruction of medical records required to be maintained;
7.1.6. Failure to comply with patient care reporting requirements established by the Secretary;
7.1.7. A willful or consistent pattern of failure to complete details on a patient’s medical record;
7.1.8. Having a license, certification, or other authorization to practice a health care profession or occupation revoked, suspended, or subjected to disciplinary sanction;
7.1.9. Improper disclosure of confidential patient information;
7.1.10. Violating a duty imposed by W. Va. Code §16-4C-1 et seq., this rule, or an order of the Secretary previously entered in a disciplinary proceeding; or
7.1.11. Other reasons determined by the Secretary which may pose a threat to the health and safety of the public or expose the public to risk or loss of life or property.
7.2. The Secretary may initiate complaints and investigations and impose the sanctions upon EMS agencies described in W. Va. Code §16-4C-9. Reasons for such actions include, but are not limited to:
7.2.1. Failure to comply with any requirements of section 4 of this rule;
7.2.2. Operating EMS vehicles which fail to comply with section 5 of this rule;
7.2.3. Failure to comply with all applicable rules, policies, and procedures of OEMS;
7.2.4. Disclosure of medical or other information, if prohibited by federal or state law;
7.2.5. Preparation or filing of false medical reports or records, or the inducement of other persons to do so;
7.2.6. Failure to disclose illegal, unethical acts and conduct of EMS personnel or agencies to OEMS;
7.2.7. Failure to report to OEMS, within 10 days, any known arrest, indictment, misdemeanor, or felony conviction, or revocation, suspension, or other disciplinary sanction of a certificate or other authorization to practice any health care profession or occupation in any state for all EMS personnel affiliated with the agency;
7.2.8. Destruction of medical records required to be maintained;
7.2.9. Refusal to render emergency medical care because of a patient’s race, gender, creed, national origin, age, disability, medical problem, or financial inability to pay;
7.2.10. Violating a duty imposed by W. Va. Code §16-4C-1 et seq., this rule, or an order of the Secretary previously entered in a disciplinary proceeding; or
7.2.11. Other reasons determined by the Secretary which may pose a threat to the health and safety of the public or exposes the public to risk or loss.
7.3. Investigation. -- The Secretary will conduct an investigation with the intent to obtain appropriate resolution of a complaint.
7.3.1. OEMS may conduct investigations in conjunction with licensed agencies or law enforcement personnel as well as conduct separate and distinct investigations.
7.3.2. OEMS will investigate any and all matters within its jurisdiction, in accordance with established investigative protocols.
7.3.3. If it is determined that OEMS does not have jurisdiction over an investigative matter, OEMS may refer the complaint to another agency or organization having jurisdiction.
7.3.4. Initiation of an OEMS investigation does not release an EMS agency or other responsible entity from performing an internal investigation or imposing sanctions.
7.4. A person who files false or slanderous allegations against EMS personnel is subject to penalties for civil as well as criminal false reporting.
7.5. Disciplinary and Corrective Action. -- The Secretary may impose disciplinary or corrective measures in this rule upon EMS agencies and EMS personnel for non-compliance with this rule. Disciplinary options may include, but are not limited to, one or more of the following:
7.5.1. Administrative penalties of up to $5,000 per violation;
7.5.2. Denial of licensure;
7.5.3. Written reprimand;
7.5.4. Limitation on the license holder’s authorization to practice;
7.5.5. Limitation of the EMS agency’s license to provide service;
7.5.6. Required refresher courses or other education at the individual’s expense;
7.5.7. A consent agreement;
7.5.8. Probation;
7.5.9. Suspension;
7.5.10. Revocation; and
7.5.11. Mandatory participation and successful completion of a detoxification or rehabilitation program at the individual’s expense.
7.6. The factors which may be considered by the Secretary when determining the appropriate disciplinary action include, but are not limited to:
7.6.1. The nature and severity of the actions under consideration;
7.6.2. Any actual or potential harm to the public or public trust;
7.6.3. Any actual or potential harm to a patient;
7.6.4. The individual’s prior disciplinary record;
7.6.5. Prior remediation;
7.6.6. The number or variety of the actions under consideration;
7.6.7. Any aggravating evidence;
7.6.8. Any mitigating evidence;
7.6.9. Any discipline imposed by OEMS or the State Medical Director, if any, for the same occurrence; and
7.6.10. In cases of criminal conviction or arrest, compliance with the terms of the sentence or court ordered conditions.
7.7. Administrative Penalties. -- OEMS may impose an administrative penalty of up to $5,000 per violation on any licensee or certificate holder found by the preponderance of the evidence to have committed any of the infractions described by this rule.
7.7.1. In assessing penalties, OEMS will give due consideration to the appropriateness of the penalty with respect to factors that include the gravity of the violation, the good faith of the licensee or certificate holder, the history of previous violations, and the totality of the discipline to be imposed.
7.7.2. Penalties shall be paid in a manner prescribed by the Secretary within 60 days of receipt of notice of a penalty.
7.8. The procedures for hearings, rights of appeal, and judicial review apply as set forth in W. Va. Code §16-4C-10.
7.8.1. It is the intention of this rule to safeguard the residents of West Virginia by preventing any person who may be unfit or unqualified from engaging in EMS and to safeguard the interests of EMS personnel by affording them due process of law and an opportunity for fair notice and a meaningful hearing.
7.9. Confidentiality of Proceedings.
7.9.1. Any action taken by the Secretary prior to the completion of administrative remedies and procedures established by W. Va. Code §16-4C-10 and §29A-5-1 et seq. will remain confidential to the greatest extent consistent with the public good and state law.
7.9.2. The Secretary will communicate proposed action prior to the completion of the administrative remedies and procedures only to the affected individual, his or her EMS agency, the agency’s medical director, and the regional medical director of the region affected.
7.10. Filing Papers.
7.10.1. Written communications concerning proceedings under this rule must be filed with the Secretary by mailing the communications to OEMS, and the Secretary will consider the postmark on the communications to be the filing date of the communications.
7.10.2. The Secretary will furnish copies of the written communications to the affected individual, his or her EMS agency’s official representative, the agency’s medical director, and the regional medical director for the region affected, and a notation shall be endorsed on the communications showing those persons who have been furnished copies.
7.11. Emergency Suspension. -- The Secretary or Director may issue an emergency suspension order to any licensee or certificate holder if there is probable cause that the conduct or continued service or practice of any licensee or certificate holder may create danger to public health or safety.
7.11.1. An emergency suspension is effective immediately without a hearing or prior notice to the license or certificate holder. Notice to the license or certificate holder will be presumed established on the date that a copy of the signed emergency suspension order is sent to the licensee or certificate holder via U.S. certified mail, return receipt requested, at the address shown in the current records of OEMS or via personal service.
7.11.2. The Secretary will send a copy of the emergency suspension order to the licensee’s or certificate holder’s EMS agency’s official representative and medical director and may send the order to other parties whose legitimate interests may be at risk;
7.11.3. Written request for a hearing must be received within 10 days of the notification of suspension order. The written request shall specify the grounds for the appeal;
7.11.4. Upon receipt of the written request, OEMS will respond to the request for a hearing within 10 days;
7.11.5. Appeals are governed by W. Va. Code §29A-5-1 et seq.
W. Va. Code R. § 64-48-8 Education
8.1. Endorsement of Sponsors of Continuing Education. -- The Secretary may grant endorsement to an applicant as a continuing education sponsor provided that the applicant meets the following requirements:
8.1.1. Entities and institutions must apply in a format prescribed by the Secretary;
8.1.2. Continuing education programs must contribute directly to the professional competence, skills, and education of EMS personnel;
8.1.3. Lead instructors must possess the necessary practical and academic skills to conduct the courses effectively and meet all standards specified by OEMS;
8.1.4. Visiting instructors shall possess the necessary practical and academic skills to present specific content effectively;
8.1.5. Continuing education program materials must be written and distributed to attendees at or before the time offered, whenever practical;
8.1.6. Continuing education programs must be presented in a suitable manner appropriate to the educational purpose of the specific course, which may include asynchronous learning resources such as online or web-based instruction: Provided: That, OEMS may, by policy, place restrictions on the total number of hours of continuing education that may be obtained by asynchronous learning;
8.1.7. Continuing education programs must be submitted and approved in a manner and time frame specified by OEMS;
8.1.8. If the continuing education sponsor is a licensed EMS agency, the agency shall be in compliance with the OEMS standards for Agency Training Officer Programs. The Agency Training Officer Program must have at a minimum:
8.1.8.a. An Agency Training Coordinator -- Must meet the standards and policies set forth by OEMS; or
8.1.8.b. An Agency Training Officer -- Must meet the standards and policies set forth by OEMS.
8.1.9. Endorsement of the continuing education sponsor is effective for five calendar years unless the program’s endorsement is revoked under subsection 8.5. of this rule.
8.2. BLS Training Institutes. -- A BLS training institute must be a secondary or post-secondary institution, or a consortium of secondary or post-secondary institutions or other entities determined by OEMS to be qualified to deliver EMS education. To qualify for endorsement as a BLS training institute, the entity shall comply with the following:
8.2.1. Criteria. -- The institute shall demonstrate the ability to conduct one or more of the following training programs:
8.2.1.a. An EMT original course compliant with Department of Transportation (DOT) National EMS Education Standards or standards approved by OEMS;
8.2.1.b. An EMT Refresher course compliant with DOT National EMS Education Standards or standards approved by OEMS;
8.2.1.c. An EMR course compliant with DOT National EMS Education Standards or standards approved by OEMS;
8.2.1.d. An EMR refresher course compliant with DOT National EMS Education Standards or standards approved by OEMS; or
8.2.1.e. An EMD course compliant with DOT National Education Standards or standards approved by OEMS.
8.2.2. Personnel.
8.2.2.a. Medical Director. -- The institute shall have a medical director who is a physician licensed in the state of West Virginia. The medical director must be experienced in emergency medical care and will assist with:
8.2.2.a.1. Practical skills development and testing;
8.2.2.a.2. Recruitment, selection, and orientation of the training institute’s faculty;
8.2.2.a.3. Providing medical advice and assistance to the training institute’s faculty and students; and
8.2.2.a.4. Provide medical oversight for student clinical practice.
8.2.2.b. Administrative Director. -- A BLS training institute shall have an administrative director who has experience in educational administration. Responsibilities of the administrative director include:
8.2.2.b.1. Application processing and oversight of the student selection process;
8.2.2.b.2. Class scheduling and the assignment of instructors;
8.2.2.b.3. The provision and maintenance of required training equipment;
8.2.2.b.4. Requesting written and practical examinations;
8.2.2.b.5. The maintenance and submission of student records in a manner specified by OEMS;
8.2.2.b.6. The selection and supervision of qualified instructors and skills evaluators;
8.2.2.b.7. Management of the EMS budget for the institute; and
8.2.2.b.8. Administering the grievance procedure as outlined in paragraph 8.2.4.c. of this rule.
8.2.2.c. Lead Instructor. -- A BLS training institute shall designate a lead instructor for each educational program conducted by the training institute. Lead instructors must possess the necessary practical and academic skills to conduct programs effectively and comply with all instructor standards specified by OEMS. The lead instructor is responsible for the management and supervision of specific BLS educational programs offered by the training institute.
8.2.2.d. Visiting Instructors. -- A BLS training institute may use the services of adjunct faculty for specific portions of an educational program. The faculty must have expertise in a particular area and are not required to be certified EMS personnel or have specific EMS experience. A visiting instructor is not eligible to be a lead instructor.
8.2.2.e. BLS Practical Skills Evaluator. -- Must meet the standards and policies set forth by OEMS;
8.2.3. Facilities and Equipment. -- The institute shall maintain, or by agreement have available, facilities necessary for the provision of BLS training courses. The facilities shall include classrooms and space for equipment storage and shall be a suitable setting devoted to the educational purpose of the course. The institute shall provide and maintain the essential equipment and supplies to provide all approved programs of instruction as determined by OEMS.
8.2.4. Operating Procedures.
8.2.4.a. The institute shall develop and implement an anti-discrimination policy with respect to student selection and faculty recruitment.
8.2.4.b. The institute shall maintain records on each enrolled student that include class performance, practical and written examination results, and reports made concerning the progress of the student during the training program.
8.2.4.c. The institute shall provide a mechanism by which students may appeal decisions made by the institute regarding dismissal or other disciplinary action.
8.2.4.d. The institute shall provide students with a clear description of the program and its content including learning goals, course objectives, and competencies to be attained.
8.2.4.e. The institute shall submit documentation of all educational programs in a manner specified by OEMS;
8.2.5. Liability. -- The institute shall provide evidence of professional liability and errors and omissions insurance in the amount of $1,000,000 for all training programs offered by the institute; and
8.2.6. The endorsement of the BLS Training Institute is effective for five calendar years unless the program’s endorsement is revoked under subsection 8.5. of this rule.
8.3. ALS Training Institutes. -- An ALS training institute must be a post-secondary institution, or a consortium of post-secondary institutions and other entities determined by OEMS to be qualified to deliver EMS education. To qualify for endorsement as an ALS training institute, the entity shall comply with the following:
8.3.1. Training Programs. -- The institute shall evidence the ability to conduct one or more of the following training programs:
8.3.1.a. A paramedic course compliant with DOT National EMS Education Standards or standards approved by OEMS;
8.3.1.b. A paramedic refresher course compliant with DOT National EMS Education Standards or standards approved by OEMS;
8.3.1.c. An AEMT course, compliant with DOT National EMS Education Standards or standards approved by OEMS; or
8.3.1.d. An AEMT refresher course, compliant with DOT National EMS Education Standards or standards approved by OEMS.
8.3.2. Clinical Agreements. -- The ALS training institute shall maintain appropriate clinical agreements with hospitals and ALS prehospital care agencies for the provision of student clinical experiences.
8.3.3. Personnel.
8.3.3.a. Medical Director. -- An institute shall have a medical director who is a physician licensed in the state of West Virginia. The medical director must be experienced in emergency medical care and shall assist with:
8.3.3.a.1. Practical skills development and testing;
8.3.3.a.2. Recruitment, selection, and orientation of training institute faculty;
8.3.3.a.3. Providing medical advice and assistance to training institute faculty and students;
8.3.3.a.4. Providing medical oversight for student clinical practice;
8.3.3.a.5. Identifying and approving facilities and ALS services where students can fulfill clinical and field internship requirements; and
8.3.3.a.6. Identifying and approving individuals to serve as field and clinical preceptors for supervising and evaluating student performance when fulfilling clinical and field internship requirements.
8.3.3.b. Program Director. -- The program director must have a Bachelor’s Degree in a related field and at least three years of experience in education administration and three years of experience in ALS patient care. The responsibilities of the program director include:
8.3.3.b.1. Application processing and oversight of the student selection process;
8.3.3.b.2. Class scheduling and the assignment of instructors;
8.3.3.b.3. Provision and maintenance of required training equipment;
8.3.3.b.4. Requesting written and practical examinations;
8.3.3.b.5. Maintenance and submission of student records in a manner specified by OEMS;
8.3.3.b.6. Selecting and supervising qualified course coordinators, instructors, and skills evaluators;
8.3.3.b.7. Managing the EMS education budget for the institute; and
8.3.3.b.8. Administering a grievance procedure as outlined in paragraph 8.2.4.c. of this rule.
8.3.3.c. Lead Instructor. -- The ALS training institute shall designate a lead instructor for each course of instruction conducted by the training institute. A lead instructor must possess the necessary practical and academic skills to conduct programs effectively and comply with all instructor standards specified by OEMS. Specific duties of the lead instructor also include:
8.3.3.c.1. Scheduling and supervising course instructors;
8.3.3.c.2. Scheduling and supervising student clinical activities and field internships;
8.3.3.c.3. Maintenance and submission of student records in a manner specified by OEMS;
8.3.3.c.4. Providing counseling services for students; and
8.3.3.c.5. Development of course syllabi and instructional resources.
8.3.3.d. Clinical Preceptors. -- The ALS training institute shall ensure the availability of qualified clinical preceptors for each clinical rotation. The clinical preceptor is responsible for the supervision and evaluation of students while fulfilling clinical requirements in an approved facility.
8.3.3.e. Field Preceptors. -- The ALS training institute shall ensure the availability of qualified field preceptors for each student. The field preceptor is responsible for the supervision and evaluation of students while fulfilling field internships with an approved ALS service.
8.3.3.f. Visiting Instructors. -- An ALS training institute may use adjunct faculty for specific portions of an educational program. The faculty must have expertise in a particular area and are not required to be certified personnel or have specific EMS experience. A visiting instructor is not eligible to be lead instructor.
8.3.3.g. ALS Practical Skills Evaluator. -- Must meet the standards and policies set forth by OEMS;
8.3.4. Facilities and Equipment. -- The institute shall maintain, or by agreement have available, facilities necessary for the provision of ALS training courses. The facilities must include classrooms and space for equipment storage, and be a suitable setting devoted to the educational purpose of the course. The institute shall provide and maintain the essential equipment and supplies to provide all approved programs of instruction as determined by OEMS;
8.3.5. Operating Procedures.
8.3.5.a. The institute shall develop and implement an anti-discrimination policy with respect to student selection and faculty recruitment.
8.3.5.b. The institute shall maintain records on each enrolled student including class performance, practical and written examination results, and reports made concerning the progress of the student during the training program.
8.3.5.c. The institute shall provide a mechanism by which students may appeal decisions made by the institute regarding dismissal or any other disciplinary action.
8.3.5.d. The institute shall provide students with a clear description of the program and its content, including learning goals, course objectives, and competencies to be attained.
8.3.5.e. The institute shall submit documentation of all education programs in a manner specified by OEMS.
8.3.6. Liability. -- The institute shall provide evidence of professional liability and errors and omissions insurance in the amount of $1,000,000 for all training programs offered by the institute.
8.3.7. Endorsement of the ALS Training Institute is effective for five calendar years unless the program endorsement has been revoked under subsection 8.5. of this rule.
8.3.8. Alternative Recognition Method.
8.3.8.a. In lieu of the standards prescribed in subdivisions 8.3.1 through 8.3.7. of this section, OEMS may endorse any institute that is accredited by a nationally recognized accrediting agency for EMS educational programs, provided that the standards used by that agency meet or exceed state endorsement standards. In addition, the following conditions apply:
8.3.8.a.1. An OEMS official shall accompany national accrediting agency officials during site visits to the ALS Training Institute; and
8.3.8.a.2. The accrediting agency shall forward a copy of the findings of the site visit directly to OEMS.
8.4. Critical Care Training (CCT) Institutes. -- A CCT training institute must be a post-secondary institution, or a consortium of post-secondary institutions and other entities determined to be qualified by OEMS to deliver EMS education. To qualify for endorsement as a CCT training institute, the entity shall comply with the following:
8.4.1. Training Programs. -- The institute shall demonstrate the ability to conduct the following training programs approved by the Secretary:
8.4.1.a. A CCT course compliant with OEMS Standards; and
8.4.1.b. A CCT refresher course compliant with OEMS Standards;
8.4.2. The CCT training institute shall maintain appropriate clinical agreements with hospitals and ALS prehospital care agencies for the provision of student clinical experiences.
8.4.3. Personnel.
8.4.3.a. Medical Director. -- An institute shall have a medical director who is a physician licensed in the state of West Virginia. The medical director must be experienced in critical care medicine. The responsibilities of the medical director include:
8.4.3.a.1. Assuring that the course content is in compliance with standards set by OEMS;
8.4.3.a.2. Assisting with the recruitment, selection, and orientation of the training institute’s faculty;
8.4.3.a.3. Providing technical advice and assistance to the training institute’s faculty and students;
8.4.3.a.4. Approving the content of written and practical skills and participating in the final skills evaluation;
8.4.3.a.5. Identifying and approving facilities and CCT services where students can fulfill clinical and field internship requirements; and
8.4.3.a.6. Identifying and approving individuals to serve as qualified field and clinical preceptors.
8.4.3.b. Lead Instructor. -- The CCT training institute shall designate a lead instructor for each educational program conducted by the training institute. A lead instructor must possess the necessary practical and academic skills to conduct programs effectively and comply with all instructor standards specified by OEMS. The lead instructor is responsible for the management and supervision of specific CCT educational programs offered by the training institute. The duties of the lead instructor include:
8.4.3.b.1. Application processing and oversight of the student selection process;
8.4.3.b.2. Class scheduling and the assignment of instructors;
8.4.3.b.3. Providing and maintaining required training equipment;
8.4.3.b.4. Requesting written and practical examinations;
8.4.3.b.5. Maintaining and submitting of student records in a manner specified by OEMS; and
8.4.3.b.6. Selecting and supervising qualified instructors and skills evaluators.
8.4.3.c. Clinical Preceptors. -- The CCT training institute shall ensure the availability of qualified clinical preceptors for each clinical rotation. The clinical preceptor is responsible for the supervision and evaluation of students while fulfilling clinical requirements in an approved facility.
8.4.3.d. Field Preceptors. -- The CCT training institute shall ensure the availability of qualified field preceptors for each student. The field preceptor is responsible for the supervision and evaluation of students while fulfilling field internships with an approved CCT service.
8.4.3.e. Visiting Instructor. -- A CCT training institute may use adjunct faculty for specific portions of an educational program. The faculty must have expertise in a particular area and are not required to be certified EMS personnel or have specific EMS experience. A visiting instructor is not eligible to be the lead instructor.
8.4.3.f. CCT Practical Skills Evaluator. -- Must meet the standards and policies as set forth by OEMS;
8.4.4. Facilities and Equipment. -- The institute shall maintain, or by agreement have available, facilities necessary for the provision of CCT training courses. The facilities must include classrooms and space for equipment storage and shall be a suitable setting devoted to the educational purpose of the course. The institute shall provide and maintain the essential equipment and supplies to provide all approved programs of instruction as determined by OEMS;
8.4.5. Operating Procedures.
8.4.5.a. The institute shall develop and implement an anti-discrimination policy with respect to student selection and faculty recruitment.
8.4.5.b. Records must be maintained on each enrolled student which includes class performance, practical and written examination results, and reports made concerning the progress of the student during the training program.
8.4.5.c. The institute shall provide a mechanism by which students may appeal decisions made by the institute regarding dismissal or any other disciplinary action.
8.4.5.d. Students must be provided with a clear description of the program and its content, including learning goals, course objectives, and competencies to be attained.
8.4.5.e. The institute shall submit documentation of all educational programs in a manner specified by OEMS;
8.4.6. Liability. -- The institute shall provide evidence of professional liability and errors and omissions insurance in the amount of $1,000,000 for all training programs offered by the institute.
8.4.7. The endorsement of the CCT Training Institute is effective for five calendar years unless the program’s endorsement is revoked under subsection 8.5. of this rule.
8.5. Renewal, Suspension, or Revocation of Endorsement.
8.5.1. Renewal: At least 90 days prior to the expiration of the program’s endorsement the institute must reapply for endorsement in a format prescribed by the Secretary. The Secretary may renew the sponsor’s endorsement if the sponsor meets the following requirements:
8.5.1.a. The sponsor has offered, within the five-year endorsement period, at least:
8.5.1.a.1. Sponsors of Continuing Education -- Ten approved educational courses; or
8.5.1.a.2. Providers of Original Certification Education (BLS, ALS & CCT) -- Three approved educational courses with a cumulative 60 percent completion rate for initially enrolled students; and,
8.5.1.b. The program has maintained continual compliance with all requirements of this rule appropriate for the educational programs it provides.
8.5.2. The Secretary may suspend or revoke the endorsement of a training institute for one or more of the following:
8.5.2.a. Failure to maintain compliance with all criteria, standards, and policies set forth by OEMS;
8.5.2.b. Absence of completed programs or student enrollment in programs for two consecutive years. This absence will result in automatic revocation of program endorsement;
8.5.2.c. Failure to meet performance measures as established by OEMS;
8.5.2.d. Evidence of falsification of any program activity or student record;
8.5.2.e. Loss of independent program accreditation status, if applicable; or
8.5.2.f. Any other reasons determined by the Secretary which may pose a threat to the health and safety of the public or exposes the public to risk or loss of life or property.
8.5.3. The Secretary will give written notice to the institute’s administrative director 30 days prior to withdrawing endorsement. The notice will identify specific reasons for withdrawal of endorsement.
8.5.4. The institute has 15 days to respond to the notice. The Secretary will determine whether to verify or reconsider the withdrawal.
W. Va. Code R. § 64-48-9 Medical Direction
9.1. Offline Medical Direction.
9.1.1. State Medical Director. -- The State Medical Director must be a physician appointed by the Secretary to be in charge of overseeing the medical aspects of the West Virginia EMS system.
9.1.1.a. The State Medical Director must have:
9.1.1.a.1. A valid, unrestricted license to practice medicine in the State of West Virginia;
9.1.1.a.2. Experience in emergency management of acutely ill or injured patients;
9.1.1.a.3. Experience in online medical direction of EMS personnel;
9.1.1.a.4. Experience in the education of EMS personnel;
9.1.1.a.5. Experience in the medical audit, review, and critique of EMS personnel and agencies;
9.1.1.a.6. Board certification in emergency medicine; and
9.1.1.a.7. Experience in medical administration and management.
9.1.1.b. The State Medical Director shall:
9.1.1.b.1. Act as the primary medical authority on all medical issues pertaining to the statewide EMS system;
9.1.1.b.2. Chair the MPCC;
9.1.1.b.3. Review and recommend to the Secretary the appointment of all regional EMS Medical Directors;
9.1.1.b.4. Establish and review all system-wide medical protocols and policies in consultation with the state MPCC;
9.1.1.b.5. Designate all regional medical command centers;
9.1.1.b.6. Consult with the Secretary, as requested, concerning revocations of EMS personnel licensure;
9.1.1.b.7. Assist OEMS in establishing certification, recertification, and continuing education requirements for EMS personnel;
9.1.1.b.8. Review and recommend the designation of specialty care centers to the Secretary;
9.1.1.b.9. Maintain liaisons with the members of the Legislature on medical issues related to EMS;
9.1.1.b.10. Review state procedures, plans, and processes for compliance with current standards of emergency medical care;
9.1.1.b.11. Appoint physician specialists and other appropriate medical personnel to the MPCC;
9.1.1.b.12. Delegate portions of his or her authority to other qualified physicians; and
9.1.1.b.13. Perform other duties assigned by the Secretary.
9.1.1.c. The State Medical Director has the following authority:
9.1.1.c.1. To make the final decision on all matters of a medical nature related to OEMS;
9.1.1.c.2. To restrict privileges of EMS personnel at any time in order to assure quality patient care;
9.1.1.c.3. To establish medical policies and procedures to carry out the activities outlined in this rule; and
9.1.1.c.4. Any other authority designated by the Secretary.
9.1.2. MPCC. -- The MPCC is composed of each regional medical director and may include physicians representing specialty areas such as pediatrics, trauma, cardiology, and others as necessary. The committee serves as the primary policy making body and advisory body to the State Medical Director concerning medical issues involving the EMS system. The committee shall meet at least annually, or more frequently as necessary.
9.1.2.a. The MPCC shall:
9.1.2.a.1. Create, review, and approve treatment, triage, and transportation protocols used within the state EMS system;
9.1.2.a.2. Determine medications, equipment, and procedures used within OEMS;
9.1.2.a.3. Establish scopes of practice for all certified EMS personnel;
9.1.2.a.4. Act on and advise the State Medical Director on emergency health related issues;
9.1.2.a.5. Establish policies and procedures governing categorization of individual facility medical capabilities in order to determine the appropriateness of transport to that facility;
9.1.2.a.6. Implement procedures necessary to carry out its duties; and
9.1.2.a.7. Perform other duties assigned by the State Medical Director or the Secretary.
9.1.2.b. Whenever any changes in protocol, medication and procedure, scope of practice, or policy and procedure as authorized in paragraph 9.1.2.a. are proposed, a notice of the proposal will be electronically mailed to each EMS Agency and the full text of proposed changes in protocol, medication and procedure, scope of practice, or policy and procedure, will be published on the OEMS website. Notice of the proposed changes in protocol, medication and procedure, scope of practice, or policy and procedure as authorized in paragraph 9.1.2.a., is subject to a 30-day public comment period prior to their being effective. However, the MPCC may waive the public comment period when it finds that exigent circumstances exist and that the proposed changes in protocol, medication and procedure, scope of practice, or policy and procedure must be implemented immediately to ensure patient safety.
9.1.3. Regional Medical Director. -- The regional medical director must be a physician, recommended by the regional board of directors, and appointed by the Secretary in consultation with the State Medical Director to oversee medical aspects of a regional EMS system.
9.1.3.a. The regional medical director must have:
9.1.3.a.1. A valid, unrestricted license to practice medicine in the State of West Virginia;
9.1.3.a.2. Experience in emergency management of acutely ill or injured patients;
9.1.3.a.3. Experience in online medical direction of EMS personnel;
9.1.3.a.4. Experience in the education of personnel;
9.1.3.a.5. Experience in the medical audit, review, and critique of personnel and agencies; and
9.1.3.a.6. Board certification in emergency medicine. This requirement may be waived by the State Medical Director.
9.1.3.b. The Regional EMS Medical Director shall:
9.1.3.b.1. Serve as the medical liaison with the Medical Director;
9.1.3.b.2. Serve as a member of the MPCC;
9.1.3.b.3. Serve as the primary medical authority on medical issues of the regional EMS system;
9.1.3.b.4. Review the appointments of all Agency Medical Directors;
9.1.3.b.5. Implement and monitor a regional performance improvement program;
9.1.3.b.6. Educate, train, and monitor the medical command physicians who operate in the regional command centers;
9.1.3.b.7. Serve as medical director of the regional medical command center;
9.1.3.b.8. Establish and review protocols in conjunction with the MPCC;
9.1.3.b.9. Serve as medical liaison to the regional EMS board of directors;
9.1.3.b.10. Assist OEMS in ensuring that personnel in the regional EMS system comply with certification, recertification, credentialing, and continuing education requirements established by OEMS;
9.1.3.b.11. Recommend to OEMS disciplinary actions involving personnel;
9.1.3.b.12. Delegate portions of his or her authority to other qualified physicians as needed, with the approval of the State Medical Director;
9.1.3.b.13. Review plans, procedures, and processes within the region for compliance with current standards of emergency care; and
9.1.3.b.14. Meet with the Agency Medical Directors within the region, at least annually, or when necessary to disseminate information regarding activities of OEMS.
9.1.3.c. Authority. -- The Regional EMS Medical Director may restrict privileges of any prehospital personnel within the region at any time in order to assure quality patient care. This may be accomplished in conjunction with the agency Medical Director. This restriction of privileges must be according to guidelines established by OEMS.
9.1.4. Agency Medical Director. -- The agency medical director, by written agreement with the Agency, and concurrence of the Regional EMS Medical Director and State Medical Director, oversees medical aspects of an EMS agency or local EMS system and extends or restricts the privilege to practice to personnel associated with the agency.
9.1.4.a. Qualifications. -- The Agency Medical Director must possess:
9.1.4.a.1. A valid, unrestricted license to practice medicine in the State of West Virginia;
9.1.4.a.2. Experience in prehospital and emergency department management of acutely ill or injured patients;
9.1.4.a.3. The Agency Medical Director must have the following qualifications unless they are waived by the Regional Medical Director:
9.1.4.a.3.A. Experience in online medical direction of EMS personnel;
9.1.4.a.3.B. Experience in the education of EMS personnel;
9.1.4.a.3.C. Experience in the medical audit, review, and critique of EMS personnel and agencies; and
9.1.4.a.3.D. Board certification in emergency medicine; Provided: That this requirement may be waived by the Regional Medical Director.
9.1.4.b. Responsibilities. -- The Agency Medical Director shall:
9.1.4.b.1. Provide advice and guidance on all aspects of the medical care provided by the agency or county;
9.1.4.b.2. Be the physician on whose authority all medical care is administered by agency or county EMS personnel;
9.1.4.b.3. Grant, restrict, or deny privileges for EMS personnel practice within the agency or county;
9.1.4.b.4. Oversee the medical review of patient care provided by the agency or county;
9.1.4.b.5. Meet with the Regional Medical Director annually; and
9.1.4.b.6. Perform other duties assigned by the Regional Medical Director or the Secretary.
9.1.4.c. Authority. -- The Agency Medical Director may restrict privileges of EMS personnel affiliated with the agency or county at any time in order to assure quality patient care. This restriction of privileges must be according to guidelines established by OEMS.
9.2. Online Medical Direction.
9.2.1. Regional Medical Command Centers are centers designated by the MPCC and OEMS with advice of the respective Regional EMS Board of Directors to serve as the regional medical command center for all online medical control of EMS personnel operating in a particular region.
9.2.1.a. Requirements/Designation. -- Regional medical command centers shall:
9.2.1.a.1. Be equipped with appropriate communication equipment, as specified by OEMS, to communicate with EMS vehicles and personnel and interface with the OEMS communications system;
9.2.1.a.2. Meet all requirements listed in this rule;
9.2.1.a.3. Agree to abide by all policies and procedures contained in the state or regional communications systems plan as established by OEMS; and
9.2.1.a.4. Agree to abide by medical treatment protocols or guidelines, triage and destination protocols or guidelines, and other policies and procedures approved by the OEMS Medical Direction System.
9.2.1.b. Staffing. -- The Regional Command Center must be staffed 24-hours per day, 365- days per year by paramedic communication specialists and shall have ready access to medical command physicians at all times.
9.2.1.c. Responsibilities. -- The regional medical command facility shall:
9.2.1.c.1. Serve as the authoritative medical command center for its primary designated area, but with the possibility of an expanded coverage area in the event of a disaster or the inoperability of other medical command centers;
9.2.1.c.2. Control and facilitate all communications of a medical nature for the EMS agencies and personnel operating in its region including ground and aeromedical EMS vehicles;
9.2.1.c.3. Serve as the final decision maker regarding the provision of patient care for all prehospital EMS incidents within the region, including, but not limited to, interpretation and authorization of patient treatment, facility destination or diversion protocols, and guidelines;
9.2.1.c.4. Assist EMS agencies and personnel with medical direction for inter-facility transfer patient care, as needed;
9.2.1.c.5. Follow all procedures and guidelines governing delivery of medical command and direction of units as established by OEMS including, but not limited to, data collection and quality assurance;
9.2.1.c.6. Maintain a record keeping system as outlined by OEMS guidelines and make those records available to state or regional Medical Directors, or OEMS investigators, for review as requested;
9.2.1.c.7. Perform other duties assigned by regional or state medical directors; and
9.2.1.c.8. Provide online medical command to EMS personnel passing through the region who require medical direction.
9.2.1.d. Authority. -- The regional medical command center may implement procedures necessary to carry out its duties outlined in this rule and OEMS guidelines.
9.2.1.e. Alternative Facilities. -- Regions may elect to have alternate command facilities in the event of equipment malfunction or when the primary center cannot be contacted for any reason. These backup facilities must be approved by the State Medical Director and included in the regional communication plan. In the event none of the command facilities can be reached, then the receiving hospital may provide medical command as needed to EMS personnel.
W. Va. Code R. § 64-48-10 EMS Personnel in Emergency Departments
10.1. EMS personnel employed by a hospital may, in the event of a life- threatening emergency, perform their full scope of practice as outlined by the MPCC, within the hospital under the direct supervision of the attending physician.
10.2. In all other situations, EMS personnel may only perform those services outlined in the written policy and procedures established by the local facility as outlined in subsection 10.3.
10.3. Any hospital using or employing EMS personnel to provide services within the hospital emergency room or department shall develop and implement written policies and procedures governing these activities. These policies and procedures shall:
10.3.1. Include the roles, responsibilities, and specific tasks or procedures which may be performed by EMS personnel;
10.3.2. Be developed jointly by the director of nursing of the emergency room and the medical director of the emergency room or department;
10.3.3. Allow for the direct supervision of the EMS personnel by a registered professional nurse and comply with all supervision guidelines established by the Board of Registered Professional Nurses;
10.3.4. Comply with the training requirements established by OEMS;
10.3.5. Contain specific procedures governing medical review and quality improvement of services provided by EMS personnel in the hospital setting and shall include the mechanisms for identification, correction, training, and disciplinary functions associated with these activities; and
10.3.6. Be approved by the Joint Care Committee as established in subsection 10.7. of this rule.
10.4. EMS personnel may not exceed the scope of practice established by the MPCC for the individual’s licensure level.
10.5. EMS personnel must maintain active EMS licensure and meet all requirements contained in section 6 of this rule.
10.6. The medical facility shall maintain training records and in-service records of the EMS personnel in its employment and make the records available for inspection by OEMS and the Board of Examiners for Registered Professional Nurses.
10.7. The State Medical Director or designee and the President of the Board of Examiners for Registered Professional Nurses or his or her designee shall establish a Joint Care Committee for the purpose of establishing minimum guidelines for the policies and procedures to be used by the local facilities concerning the functioning of EMS personnel in the emergency room setting. These guidelines may include a list of specific procedures and activities performed by EMS personnel in the emergency room setting and shall also contain the definition of a life-threatening emergency.
W. Va. Code R. § 64-48-11 Administrative Due Process
11.1. Any person adversely affected by the enforcement of this rule desiring a contested case hearing to determine any rights, duties, interests or privileges must do so in a manner prescribed in “Rules of Procedure for Contested Case Hearings and Declaratory Rulings,” 64CSR1.
Series 49 Drinking Water Treatment Revolving Fund
W. Va. Code R. § 64-49-1 General
1.1. Scope. -- The 1996 Safe Drinking Water Act Amendments authorized a drinking water treatment revolving fund program. The federal government will provide most of the initial funding to start the West Virginia drinking water treatment revolving fund program. This program allows the State to provide financial assistance to public water systems to finance the cost of infrastructure improvements needed to comply with the requirements of the federal Safe Drinking Water Act. The fund will be administered by the water development authority. This rule establishes State-level procedures, standards for project eligibility, and gives direction to the State water development authority.
1.2. Authority. -- W. Va. Code '16-13C-2(b).
1.3. Filing Date. -- April 6, 1998.
1.4. Effective Date. -- June 1, 1998.
1.5. Administration. -- This rule is administered by the division of health of the department of health and human resources.
W. Va. Code R. § 64-49-2 Definitions
2.1. Capacity Development. -- The technical, managerial and financial capability of a public water system.
2.2. Capitalization Grant. -- The assistance agreement by which the U. S. Environmental Protection Agency obligates to award funds allotted to a State for purposes of capitalizing the State=s revolving fund and funds for other purposes authorized in Section 1452 of the safe drinking water act.
2.3. Community Water System. -- A public water system which serves at least fifteen (15) service connections used by year-round residents or regularly serves at least twenty-five (25) year-round residents.
2.4. Compliance. -- Compliance with State and Federal laws, rules and regulations applicable to public water systems.
2.5. Cross Cutter Authorities. -- Federal laws and authorities that apply by their own terms to projects or activities receiving federal assistance.
2.6. Disadvantaged Community. -- The service area of a public water system that meets the affordability criteria established in the annual intended use plan after public review and comment by the division and as approved by the U. S. Environmental Protection Agency.
2.7. Division of Health. -- The division of health of the department of health and human resources.
2.8. Drinking Water Treatment Revolving Fund. -- The fund established by W. Va. Code '16-13C-3(a) to be used for financial assistance to the public water systems for eligible project costs.
2.9. Intended Use Plan. -- A document prepared by the division each year which identifies the intended uses of the funds in the drinking water treatment revolving fund.
2.10. Public Water System. -- Any water system or supply which regularly supplies or offers to supply, piped water to the public for human consumption, if serving at least an average of twenty-five (25) individuals per day for at least sixty (60) days per year, or which has at least fifteen (15) service connections and includes:
(1) Any collection, treatment, storage, and distribution facilities under the control of the owner or operator of the system and used primarily in connection with the system, and (2) Any collection or pretreatment storage facilities not under such control which are used primarily in connection with the system.
A public water system does not include a system which meets all of the following conditions:
(1) which consists only of distribution and storage facilities (and does not have any collection and treatment facilities);
(2) which obtains all of its water from, but is not owned or operated by a public water system which otherwise meets the definition;
(3) which does not sell water to any person; and (4) which is not a carrier conveying passengers in interstate commerce.
2.11. Project Priority List. -- The list of projects that are to be funded which is published in the intended use plan.
2.12. Safe Drinking Water Act. -- The federal statute commonly known as the ASafe Drinking Water Act@, 42 U.S.C. 300f et seq., as enacted, amended, and as may be subsequently amended.
2.13. Set-Aside. -- Moneys from the capitalization grant to be used for non-project activities specific to the Safe Drinking Water Act.
2.14. Small System. -- A drinking water system serving ten thousand (10,000) or fewer persons.
2.15. Water Development Authority. -- The water development authority provided for in W. Va. Code '22C-1-4.
W. Va. Code R. § 64-49-3 Procedure
3.1. The division will receive capitalization grants from the U. S. Environmental Protection Agency for the purpose of establishing a drinking water treatment revolving fund construction fund to assist public water systems to finance the cost of infrastructure needed to comply with the Safe Drinking Water Act and to fund non-project activities defined in Section 4 of this rule.
3.2. The division shall develop an annual intended use plan for each year that the drinking water treatment revolving fund program is in place.
3.2.a. The intended use plan shall contain the proposed set-aside amounts for non-project activities that the division intends to use. The set-aside accounts are described in Section 4 of this rule.
3.2.b. The intended use plan shall contain a priority list of eligible projects per Section 5 of this rule that the State intends to fund during the fiscal year covered. The priority ranking procedure is described in Section 6 of this rule. This list shall contain at a minimum, the public water system, population served, water supply, project description, project type, estimated project cost, project priority and the expected financial terms. The financial administration is described in Section 7 of this rule.
3.2.c. The division shall also maintain a comprehensive priority list of anticipated future projects as described in Section 6 of this rule. This list shall contain the projects, the estimated priority and the expected funding schedule for each.
3.2.d. The intended use plan shall include a discussion of the financial status of the drinking water treatment revolving fund. This discussion shall include the total amount of moneys in the fund from all sources, the types of projects to be funded, the general types and terms of financial assistance to be provided, the amounts for non-project activities and the amounts used for disadvantaged communities. The procedure for disadvantaged communities is described in Section 8 of this rule and shall be included in the annual intended use plan.
3.3. The division shall submit a capitalization grant application to the U. S. Environmental Protection Agency annually during the years that capitalization grants are available for the federal drinking water treatment revolving fund program.
3.4. After the division receives U. S. Environmental Protection Agency approval of the capitalization grant application which includes the annual intended use plan, financial assistance may be made to public water systems by the water development authority as specified in Section 7 of this rule and W. Va. Code '16-13C-1 et seq.
3.5. The applicant=s procedures and requirements for drinking water treatment revolving fund assistance are described in Section 9 of this rule.
3.6. The division shall submit a biennial report to the U. S. Environmental Protection Agency regional administrator discussing the State=s activities which receive funding from the federal capitalization grant.
W. Va. Code R. § 64-49-4 Fund Establishment
4.1. Establishment of the Fund. -- The water development authority shall establish a permanent and perpetual fund to be known as the West Virginia drinking water treatment revolving fund. The fund shall be kept separate and apart from all other funds or programs of the water development authority and the division.
4.2. Establishment of Set Aside Accounts. -- There are four (4) allowable set-asides from the capitalization grant, as described in subdivisions 4.2.a through 4.2.d of this rule.
4.2.a. Program Oversight (Administration of the Fund). -- An amount up to four percent (4%) of the capitalization grant may be used for to finance the cost to the division or its agents of administering the program.
4.2.b. Technical Assistance. -- Two percent (2%) of the federal capitalization grants shall be utilized to provide technical assistance services for small systems to assist those systems in maintaining compliance with the federal safe drinking water act. The technical assistance services for small systems shall be contracted by the division to non-profit organizations that:
4.2.b.1. Have a membership that represents at least twenty-five percent (25%) of the small systems of this State; and
4.2.b.2. Have at least five (5) years of experience in providing on-site technical assistance to small systems.
4.2.c. Local Assistance. -- An amount up to fifteen percent (15%) of the capitalization grant may be used for local assistance such as, but not limited to: delineation and assessment of source water protection areas, loans for source water protection programs and well-head protection programs and capacity development assistance. Contractual services may be funded from this account for these services. No more than ten percent (10%) may be used for any one (1) activity.
4.2.d. State Activities. -- An amount up to ten percent (10%) of the capitalization grant may be used for State activities such as, but not limited to: the public water supply supervision program, source water protection, capacity development, and operator certification.
4.3. Sources of Money for the Drinking Water Treatment Revolving Fund. -- The drinking water treatment revolving fund is comprised of moneys appropriated by the legislature, moneys allocated to the State by the federal government for the purposes of establishing the drinking water treatment revolving fund, all receipts from loans made from the drinking water treatment revolving fund, all income from investment of moneys held in the drinking water treatment revolving fund, and all other sums designated for deposits to the drinking water treatment revolving fund from any source, public or private.
4.4. Use of Moneys in the Drinking Water Treatment Revolving Fund. -- Moneys in the drinking water treatment revolving fund are to be used solely to make loans and to make other allowable financial assistance to eligible projects for public water systems, as described in the Safe Drinking Water Act and in W. Va. Code '16-3C-1 et seq. Each loan shall be in an amount that covers those costs of a project for which funds are sought by the applicant from the water development authority.
4.5. Investment of Moneys in the Drinking Water Treatment Revolving Fund. -- The water development authority is permitted to invest the moneys in the drinking water treatment revolving fund that are not needed for immediate disbursement or use in obligations or securities that are lawful investments for public funds of the State.
4.6. Disbursement of Moneys from the Drinking Water Treatment Revolving Fund. -- Moneys are to be disbursed from the drinking water treatment revolving fund only upon written authorization from the director of the water development authority or his or her designee.
W. Va. Code R. § 64-49-5 Project and System Eligibility
5.1. Both community and non-community non-transient public water systems are eligible for drinking water treatment revolving fund funding, with the following exceptions:
5.1.a. For-profit non-community non-transient water systems; and
5.1.b. Federally owned public water systems.
5.2. The eligible system shall not be significantly out of compliance with any national or State drinking water rules, regulations or variances unless the division determines that the proposed project will enable it to come into compliance. The system shall provide assurances to the division that the proposed project will enable the system to attain compliance.
5.3. Subdivisions 5.3.a through 5.3.g list examples of some of the types of projects that may be funded by the drinking water treatment revolving fund. The examples listed are not to be construed as an exhaustive or limiting list of potentially eligible projects.
5.3.a. Examples of eligible public health and compliance projects are projects to:
5.3.a.1. Facilitate compliance;
5.3.a.2. Further health protection objectives;
5.3.a.3. Address exceedances of action levels and maximum contaminant levels (MCL=s) specified in the Division of Health Legislative Rule, Public Water Systems, 64 CSR 3;
5.3.a.4. Prevent future violations; and
5.3.a.5. Maintain compliance.
5.3.b. Examples of eligible restructuring projects are projects to:
5.3.b.1. Upgrade or replace infrastructure to continue to provide the public with safe drinking water;
5.3.b.2. Replace aging infrastructure, including, but not limited projects to:
5.3.b.2.A. Rehabilitate or develop water sources to replace contaminated sources;
5.3.b.2.B. Install or upgrade treatment facilities, if the installation or upgrading will improve the quality of drinking water to comply with federal primary or secondary drinking water standards as adopted in the Division of Health Legislative Rule, Public Water Systems, 64 CSR 3;
5.3.b.2.C. Install or upgrade storage facilities to prevent microbiological contaminants from entering the water system; and
5.3.b.2.D. Install or replace transmission and distribution pipes to prevent contamination caused by leaks or breaks in the pipe, or improve water pressure to safe levels.
5.3.c. Projects to consolidate water supplies are eligible when:
5.3.c.1. Individual homes or public water systems have an inadequate quantity of water;
5.3.c.2. A water supply is contaminated; or
5.3.c.2.A. The system is unable to maintain compliance for financial or managerial reasons.
5.3.d. The purchase of a portion of another system=s capacity is eligible for a loan, if the system to be purchased is a small system which is part of a consolidation plan to bring the system into compliance, and it is the most cost-effective solution for that small system, when considering the buy-in and user fees.
5.3.e. The costs of project planning, design and other related costs are eligible for drinking water treatment revolving fund funding. Funding of the design of a project does not guarantee funding of the project construction. The design loan assistance amounts shall be described in the annual intended use plan.
5.3.f. Costs of preparing environmental assessment reports (Section 11 of this rule) may be included as part of costs of planning the project and are eligible costs from the drinking water treatment revolving fund. The cost for the State to review the environmental assessments is not eligible under the drinking water treatment revolving fund and is considered administrative costs.
5.3.g. Land is an eligible cost only if it is integral to a project that is needed to meet or maintain compliance and further public protection. In this instance, land that is integral to a project is only the land needed to locate eligible treatment or distribution projects.
5.4. The following projects and activities are not eligible for drinking water treatment revolving fund assistance:
5.4.a. Dams or rehabilitation of dams;
5.4.b. Water rights, except if the water rights are owned by a system that is being purchased through consolidation as part of a capacity development strategy;
5.4.c. Reservoirs, except for finished water reservoirs that are part of the treatment process and are located on the property where the treatment facility is located;
5.4.d. Laboratory fees for monitoring;
5.4.e. Operation and maintenance expenses;
5.4.f. Projects needed mainly for fire protection;
5.4.g. Projects for systems in significant non-compliance, unless funding will ensure compliance; and
5.4.h. Projects primarily intended to serve future growth.
5.5. Projects which are designed solely for growth are not eligible for drinking water treatment revolving fund assistance, although reasonable growth may be part of an eligible project.
5.6. Current and future monitoring, operation and maintenance expenditures are not eligible for drinking water treatment revolving fund assistance.
W. Va. Code R. § 64-49-6 Priority Ranking Procedure
6.1. The division shall develop an annual intended use plan indicating how the drinking water treatment revolving fund will be used. The division shall give the highest priority to projects that:
6.1.a. Address the most serious health risks;
6.1.b. Are necessary to achieve compliance; and
6.1.c. Assist those systems most in need on a per household basis.
6.2. The intended use plan shall include criteria for bypass procedures which identify the conditions which would allow a project to be bypassed and the way in which the division will identify projects to receive the bypassed funds.
6.3. The intended use plan shall undergo public review and shall be submitted to the U. S. Environmental Protection Agency for approval.
W. Va. Code R. § 64-49-7 Financial Administration
7.1. Evidence and Security for Loans. -- Each loan shall be evidenced by revenue bonds or notes or other debt instruments issued by the applicant and purchased by the water development authority, at par or at a discount to reflect the costs of the water development authority and the division incurred to the financing, in whole or in part, of the costs of a project, and shall be secured by a pledge of the fees, charges, and all other revenues of the project to be constructed, in whole or in part, with the proceeds of the loan and any other collateral as may be required by the water development authority. The water development authority may require a water customer survey or user agreements to ensure that the proposed new customers will connect to the system.
7.2. Applications for Loans. -- A public water system that has water development authority under applicable law to undertake a project and has been approved as an eligible recipient by the division may apply for a loan. An eligible recipient desiring a loan shall make a separate application to the water development authority, on the forms prescribed by the director of the water development authority, for each project for which a loan is desired. Following approval by the water development authority and the division and when moneys are available for loan the water development authority and the division shall provide the public water system with a commitment letter setting forth the terms of the loan.
7.3. Determination of Eligible Recipients. -- Public water systems projected to be able to qualify for drinking water treatment revolving fund financial assistance shall be identified in the annual intended use plan as described in Section 3 of this rule. Only those projects on the State project priority list for the current fiscal year shall be considered by the water development authority for financial assistance from the drinking water treatment revolving fund.
7.4. Loan Agreements. -- Prior to providing a loan to an eligible recipient, the water development authority shall execute and enter into a loan agreement with the applicant which shall be binding under the laws of the State and which shall contain such provisions as may be required by the water development authority and the division under the Safe Drinking Water Act including:
7.4.a. The cost of the project, the amount of the loan and the security therefor, which may include in addition to a pledge of fees, charges and other revenues from the project after a reasonable allowance for operation, maintenance, renewal and replacement expenses, and a reasonable reserve fund;
7.4.b. A deed of trust or other appropriate security instrument creating a lien on such project: Provided, That the annual repayment of principal and payment of interest begins not later than one (1) year after the project completion and that the final payment shall not exceed twenty (20) years from said completion date except as provided in Section 8 of this rule;
7.4.c. The specific purposes for which the proceeds of the loan shall be expended, the procedures as to the disbursement of the loan proceeds including an estimated monthly draw schedule, and the duties and obligations imposed upon the applicant in regard to the acquisition or construction of the project;
7.4.d. If notes or other interim obligations are being issued by the applicant, the agreement of the applicant to issue the revenue bonds and take such other actions as are required of the applicant under the loan agreement;
7.4.e. The agreement of the applicant to accept the water development authority=s remedies in the event of any default under the loan; and
7.4.f. The agreement of the applicant to comply with all applicable federal and State statutes, rules and regulations, the applicable requirements of all federal cross cutting authorities, and all applicable local ordinances pertinent to the financing, acquisition, construction, operation, maintenance, and use of the project.
7.5. Payment of Principal and Interest on Loans. -- Payments of the principal or any interest on a loan shall be made by the applicant in accordance with the provisions of the loan agreement.
7.6. Computation of Interest on Loans. -- Each loan shall bear interest from the date of the delivery of the bonds or notes of the applicant evidencing the loan to the applicant at a rate or rates per annum, either fixed or variable, as determined by the water development authority and the division provided that said rate or rates shall be made at or below market rate as stated in the Safe Drinking Water Act (1452(f)(1)(A) and further provided that, pursuant to the provisions of the loan agreement, the interest rate or rates shall reflect the costs of the water development authority incurred in issuing its obligations, if any, and other costs related to the making of the loan.
7.7. Fees and Charges. -- In addition to payments of principal and interest on a loan, each applicant shall agree in the loan agreement to pay fees and charges to the water development authority equal to the applicant=s share of the administrative expenses of the water development authority relating to the loan program. Such fees shall be specifically identified in the loan agreement. These revenues shall be deposited and maintained in an account separate from the drinking water treatment revolving fund construction fund.
7.8. Loans Conditioned Upon Availability of Moneys in the Drinking Water Treatment Revolving Fund. -- The obligation of the water development authority to make any loan shall be conditioned upon the availability of the moneys in the drinking water treatment revolving fund in such amounts and on such terms and conditions as, in the sole judgement of the water development authority, shall enable it to make loans.
7.9. Disbursement of Loan Moneys.
7.9.a. The water development authority shall disburse to each recipient the amount certified to the water development authority as costs incurred for the project. The certification shall be made in the form prescribed by the water development authority and shall be accompanied by a written approval from the division. The director of the water development authority or his or her authorized representative shall then provide written authorization for the disbursement of the approved dollar amount to the recipient.
7.9.b. Each recipient shall comply with all terms and conditions of both the loan agreement and the resolution or ordinance authorizing the issuances of revenue bonds or notes or other debt instruments evidencing the loan.
7.10. Audit Requirements.
7.10.a. The programmatic set-aside accounts shall be audited annually in accordance with federal and State requirements, and shall use generally accepted government accounting standards.
7.10.b. The drinking water treatment revolving fund construction funds shall be audited annually with separate opinion as required by the federal government generally and as required specifically by the Safe Drinking Water Act. The audit shall be in accordance with generally accepted government accounting standards. The annual audit of the drinking water treatment revolving fund shall include an audit of the fund=s financial statements and an opinion on the financial statements and additional reports on internal controls and compliance with all federal laws and regulations.
W. Va. Code R. § 64-49-8 Disadvantaged Communities
8.1. Thirty percent (30%) of the federal capitalization grant shall be dedicated to the funding of projects for disadvantaged communities.
8.2. The subsidy options for assistance to disadvantaged communities shall be described in the annual intended use plan. Options include the following:
8.2.a. Principal forgiveness or other incentive agreed upon between the borrower and the division within the U. S. Environmental Protection Agency guidelines; and
8.2.b. Extended loan terms. The normal loan from the drinking water treatment revolving fund is twenty (20) years, but in the case of a system defined as a disadvantaged community the State may provide extended loan terms, up to thirty (30) years. The loan terms may not exceed the expected design life of the project.
W. Va. Code R. § 64-49-9 Application Procedures and Requirements
9.1. Pre-application Process.
9.1.a. The applicant shall complete and submit to the division a preliminary application package obtained from the division.
9.1.b. The application shall provide documentation that the project has been approved by the West Virginia infrastructure and jobs development council.
9.2. Pre-Bid Process.
9.2.a. The applicant shall obtain written permission from the division to bid the project. The project may be bypassed from the project priority list if the project is bid prior to receiving approval. The applicant shall meet the uniform bidding procedures of the West Virginia infrastructure and jobs development council.
9.2.b. The following documents, where applicable, shall be submitted to the division prior to bidding the project:
9.2.b.1. Updated project costs and financing plan;
9.2.b.2. A copy of the engineering agreement and the public service commission order which approved such agreement;
9.2.b.3. The public service commission=s schedule for the certificate of convenience and necessity application;
9.2.b.4. Copies of applicable permits from the division;
9.2.b.5. Evidence of other applicable permits including, but not limited to: permits from the division of environmental protection; the division of highways; and the U. S. Corps of Engineers;
9.2.b.6. Bid documents and proposed bid advertisement;
9.2.b.7. Evidence that eighty percent (80%) of all necessary easements and rights-of-way have been obtained and a list of all titles that need to be acquired with an attorney=s list of exceptions;
9.2.b.8. The project administration agreement; and
9.2.b.9.A. If the project will serve two (2) or more entities, an agreement between the entities; or
9.2.b.9.B. If the project will serve a municipality, evidence of adoption of a rate ordinance.
9.3. Pre-Loan Closing Requirements. -- Before loan closing the applicant shall submit the following documents to the division:
9.3.a. A final order from the public service commission which approves the construction and financing of the project;
9.3.b. Evidence that all applicable permits have been obtained;
9.3.c. A set of project plans prepared by a registered professional engineer;
9.3.d. An affidavit of publication of advertisement for bids;
9.3.e. A set of bid documents if changed since the previous submittal;
9.3.f. Bid tabulation certified by a registered professional engineer, indication of which bid was selected, and if the lowest bidder was not selected, an statement prepared by an attorney describing why the lowest bidder was not selected;
9.3.g. A statement by a registered professional engineer that the chosen bidder received any and all addenda to the original bid documents;
9.3.h. A statement by a registered professional engineer that the bid documents reflect the project as approved by the division, that the chosen bid includes every construction item necessary to complete the project and that the uniform bidding procedures were followed;
9.3.i. A title opinion signed by an attorney, which identifies the project and contracts and which indicates that one hundred percent (100%) of the necessary titles, easements and rights-of-way have been obtained or that the governmental agency has received rights-of-entry for the same;
9.3.j. Copies of invoices to be paid at closing;
9.3.k. Payment instructions for funds to be received at closing and on a monthly draw basis thereafter;
9.3.l. All necessary ordinances or resolutions in a form and substance satisfactory to the water development authority and assurance that the applicant has taken or will take all measures required by law to enable it to enter into a loan agreement and to issue its revenue bonds or notes for purchase by the water development authority;
9.3.m. An acceptable schedule for project initiation and completion;
9.3.n. Agreement that the applicant will follow all applicable procurement procedures set forth by State laws and rules;
9.3.o. Documentation that the applicant has obtained approval of user charges necessary to finance the project;
9.3.p. Documentation that the applicant has the financial, managerial and technical capability to complete the project;
9.3.q. Documentation that an environmental review per section 11 of this rule has been completed; and
9.3.r. Documentation that all federal cross-cutters have been addressed in project planning and assurances that the applicant will comply with applicable cross-cutters during project construction.
9.4. Construction and Post Construction.
9.4.a. The system shall follow all applicable procurement procedures set forth by the West Virginia Code.
9.4.b. The recipient shall establish and maintain a financial management system to account for all the costs incurred related to the project. The financial management system shall assure that generally accepted accounting principles and practices are consistently applied in all financial matters related to the project. Financial management shall include the following:
9.4.b.1. The establishment of appropriate controls over project funds, property, and other assets;
9.4.b.2. The maintenance of ledgers containing accurate, current and complete records of all financial actions related to the project;
9.4.b.3. The maintenance of records that identify the source and amount of all moneys used for the project and document how such moneys were used;
9.4.b.4. The maintenance of records that allow a comparison of actual project costs with budgeted costs; and
9.4.b.5. The establishment of procedures that assure a timely resolution of audit findings and recommendations.
9.5. In maintaining the accounting system, the recipient shall:
9.5.a. Establish a separate account for the project;
9.5.b. Record all transactions in ledgers;
9.5.c. Record all transactions in a timely manner;
9.5.d. Designate one (1) person who is responsible for project operations to account for all project funds;
9.5.e. Prepare and submit to the division monthly reports of the financial status of the project; and
9.5.f. Prepare and submit to the division an annual budget for the project.
9.6. The recipient shall maintain records for each loan received that include:
9.6.a. Loan application and loan approval documents;
9.6.b. All contracts and sub-agreements related to the project;
9.6.c. All documents related to the financial management;
9.6.d. All documents requiring action by the State;
9.6.e. Documentation of compliance with applicable federal and State laws, rules, and regulations;
9.6.f. Documentation of moneys received and expended; and
9.6.g. A statement by a registered professional engineer that the as-built project is in accordance with the plans and specifications approved by the division and that the as-built project is in proper working condition.
9.7. All records maintained shall be made available for inspection by the director upon request.
9.8. Prior written approval from the division shall be obtained for any change orders to the construction contract.
9.9. Explanation of any project budget item overrun shall be submitted with that month=s funds draw request.
W. Va. Code R. § 64-49-10 Capacity Development
The division shall, by August, 2000, establish a capacity development strategy to define systems and assist systems in developing and maintaining technical, financial and management capability. The strategy shall be designed to ensure that all new community water systems and non-community non-transient water systems demonstrate technical, managerial and financial capability needed to comply with applicable federal and State laws, rules and regulations for drinking water.
W. Va. Code R. § 64-49-11 Environmental Review
11.1. An environmental review shall be completed for each project that receives funds from the drinking water treatment revolving fund. Any adverse environmental impacts that may occur on a project, as determined by the director, shall be mitigated by the local entity.
11.2. The director hereby adopts and incorporates by reference the provisions contained in 40 CFR Part 6 subpart E and related subparts as applicable to drinking water systems.
11.3. The costs of preparing the environmental assessment reports may be included as part of costs of planning the project and are eligible for drinking water treatment revolving fund assistance. The cost for the State to review the environmental assessments are not eligible from the drinking water treatment revolving fund and are considered administrative costs. Environmental reviews required by other funding agencies participating in the funding of the project may fulfill the requirements for environmental review. The applicant shall obtain written approval from the division.
W. Va. Code R. § 64-49-12 Records
The division shall maintain files for each drinking water treatment revolving fund project.
W. Va. Code R. § 64-49-13 Administrative Due Process
Those persons adversely affected by the enforcement of this rule desiring a contested case hearing to determine any rights, duties, interests or privileges shall do so in a manner prescribed in W. Va. Division of Health Administrative Rules, Rules and Procedures for Contested Case Hearings and Declaratory Rulings, 64 CSR 1.
The Department of Health and Human Resources (DHHR) was created by the Legislature's reorganization of the executive branch of State government in 1989. The Department of Public Health was renamed the Division of Health and made a part of the DHHR (W. Va. Code ' 5F-1-1 et seq.). Administratively within the DHHR the Bureau for Public Health through its Commissioner carries out the public health function of the Division of Health.
See footnote 1.
64CSR49
Series 51 Fees for Services
W. Va. Code R. § 64-51-1 General
1.1. Scope. -- This rule establishes reasonable fees for services provided by the Bureau for Public Health. This legislative rule does not supersede other rules which establish fees for services not addressed in this rule.
1.2. Authority. -- W. Va. Code §16-1-4.
1.3. Filing Date. -- April 13, 2026.
1.4. Effective Date. -- July 1, 2026.
1.5. Sunset Provision. -- This rule shall terminate and have no further force or effect on August 1, 2031.
W. Va. Code R. § 64-51-2 Application and Enforcement
2.1. Application. -- This rule applies to persons receiving services from the Bureau for Public Health.
2.2. Enforcement. -- This rule is enforced by the Commissioner of the West Virginia Bureau for Public Health or his or her lawful designee.
W. Va. Code R. § 64-51-3 Definitions
3.1. Adoption -- The judicial act of creating the relationship of parent and child where it did not exist previously.
3.2. Ambulatory Surgical Facility (ASP) -- A facility which provides surgical treatment to patients not requiring hospitalization. This definition does not include the legally authorized practice of surgery by any one or more persons in the private office of any health care provider.
3.3. Asbestos -- The asbestiform varieties of serpentinite (chrysotile), riebeckite (crocidolite), cummingtonite-grunerite, anthophyllite, and actinolite-tremolite, which contains more than one percent asbestos by weight.
3.4. Asbestos Abatement -- Procedures to control fiber release from asbestos-containing materials. These procedures include removal, encapsulation, enclosure, repair, demolition, renovation, and similar activities.
3.5. Assisted Living Residence -- Any living facility, residence, or place of accommodation, however named, available for four or more residents, in this state which is advertised, offered, maintained, or operated by the ownership or management, whether for a consideration or not, for the express or implied purpose of having personal assistance or supervision, or both, provided to any residents therein who are dependent upon the services of others by reason of physical or mental impairment and who may also require nursing care at a level that is not greater than limited and intermittent nursing care. This term replaces the two terms “Personal Care Home” and “Residential Board and Care Home” previously used in this rule.
3.6. Basic Public Health Services -- Those services that are necessary to protect the health of the public. The three areas of basic public health services are communicable and reportable disease prevention and control, community health promotion, and environmental health protection.
3.7. Behavioral Health Center -- An organization that provides behavioral health services, including all of its locations.
3.8. Behavioral Health Services -- An inpatient, residential, or outpatient service for the care and treatment of persons with mental illness, developmental disabilities, or substance abuse.
3.9. Birthing Center -- A type of facility, which is a building, house, or the equivalent organized to provide facilities and staff to support a birthing service for pregnant women.
3.10. Bottled Water -- Any natural or artificial mineral, spring, well, distilled, or other water bottled or containerized for use primarily as drinking water.
3.11. Business (or Individual) Providing Vendor Services -- Any person proposing to offer or providing services to Registrants in the Radiological Health Program as described in the bureau’s legislative rule, Radiological Health, 64CSR23, subsections 5.4. and 5.5.
3.12. Certificate of Birth (Birth Certificate) -- The government’s permanent legal record of the fact of birth of an individual. Information contained within the document is considered to be prima facie evidence of the fact of birth.
3.13 Certificate of Death (Death Certificate) -- The government’s permanent legal record of the fact of death of an individual. Information contained within the document is considered to be prima facie evidence of the fact of death.
3.14 Certified Copy -- A reproduction or abstracted document that is officially endorsed by the custodian of the original document to be an authentic reproduction or abstraction of the original document.
3.15. Commissioner -- The Commissioner of the West Virginia Bureau for Public Health.
3.16. Decommissioning -- Removal of any source of radioactive material as described in the bureau’s legislative rule, Radiological Health, 64CSR23, subsection 6.59, subdivisions 11.14.f. or 16.23.c. with a dedicated purpose of vacating premises, amendment, or cancellation of a registration for possession or storage of radioactive material.
3.17. Delayed Certificate of Birth (Delayed Birth Certificate) -- A certificate of birth filed more than one year after the date of birth. Information contained within the document is abstracted from other sources and is not considered to be prima facie evidence of the fact of birth.
3.18. Dental Intraoral Machine -- A radiation machine with one or more x-ray tubes used for human intraoral diagnostic imaging, as described in the bureau’s legislative rule, Radiological Health, 64CSR23, subsection 7.9.
3.19. Dental Panoramic Machine -- Any rotational orthodontic extraoral radiographic device for dental diagnostic imaging.
3.20. Dental Radiation Machine (Other) -- Any radiographic device for dental diagnostic imaging, which is not dental intraoral or dental panoramic, such as cephalometric and extraoral tomography with one or more x-ray tubes.
3.21. Drinking Water -- Water free from biological, chemical, physical, and radiological contaminants which cause disease or harmful physiological effects.
3.22. Emergency Services Consultation -- A consultation for radiological health services performed per request for regulatory assistance in the event of an emergency or crisis condition involving a source of radiation. Consultation includes the following per event: investigation, travel time, and assessment of incidents or accidents for compliance with the Bureau’s rule, Radiological Health Rules, 64CSR23, involving unusual events such as exposure to ionizing radiation to workers or the public, contamination of persons or the environment, and release, damage, theft, or loss of radioactive material.
3.23. End Stage Renal Disease (ESRD) Facility -- A facility which is approved to furnish at least one specific ESRD service, e.g., that stage of renal impairment that appears irreversible and permanent and requires a regular course of dialysis or kidney transplantation to maintain life.
3.24. Food Manufacturing Facility -- Any entity that manufactures, processes, or packs food for human consumption and conducts wholesale operations. This term does not include farms, facilities regulated by the bureau’s legislative rule, Food Establishments, 64CSR17, or facilities under the regulatory authority of the West Virginia Department of Agriculture.
3.25. Generator -- A person whose activity results in the production of low-level radioactive waste requiring long-term storage and disposal.
3.26. Hospice -- A hospice as defined in W. Va. Code §16B-8-2(b).
3.27. Hospital -- A hospital as defined in W. Va. Code §16B-3-1.
3.28. Industrial Radiographic Machine -- A radiation machine used for all industrial radiography, other than cabinet radiography and shielded room radiography and other non-diagnostic or non-therapeutic purposes, such as x-ray devices used to examine the macroscopic structure of materials by nondestructive methods using sources of ionizing radiation or to produce radiographic images, as defined in the bureau’s legislative rule, Radiological Health, 64CSR23, subdivisions 8.3.5. and 8.3.6.
3.29. Industrial Cabinet X-Ray System -- A machine used for industrial radiography conducted in an enclosure or shielded cabinet, such as x-ray devices used primarily for the inspection of carry-on baggage at airline, railroad, and bus terminals, and in similar facilities, as defined in the bureau’s legislative rule, Radiological Health, 64CSR23, subdivisions 8.3.1. or 8.3.2.
3.30. Industrial High Energy Machine -- A radiation producing device such as a particle accelerator or cyclotron, and pulse x-ray machine used for nondestructive testing or other radiation producing devices used for irradiation of materials with energies greater than 250 kilovolts.
3.31. Industrial Radiation Machine (Other) -- A radiation machine used for non-human purposes other than those described in this section as: Industrial Radiographic Machine, Industrial Cabinet X-Ray System, or Industrial High Energy Machine.
3.32. Innovative/Alternative Type Sewage System -- A method of sewage disposal for a single-family dwelling or establishment for which design standards have been prepared and listed in the bureau’s legislative rule, Sewage Treatment and Collection System Design Standards, 64CSR47, as an innovative or alternative system.
3.33. Legitimation -- Legal process by which the state of legitimacy is conferred to a child whose parents were not married at the time of the child’s birth but who subsequently marry each other.
3.34. Low-Level Radioactive Waste -- Radioactive waste that:
3.34.1. Is not classified as high-level radioactive waste, spent nuclear fuel, or byproduct material as defined in Section 11.e(2) of the Atomic Energy Act of 1954 (uranium or thorium tailings and waste); and
3.34.2. Is classified as low-level radioactive waste consistent with existing federal law in accordance with the U.S. Nuclear Regulatory Commission rules, as defined in the bureau’s legislative rule, Radiological Health, 64CSR23, subsection 3.106., and the Low-level Radioactive Waste Policy Act, Public Law 96-573, as amended by Public Law 99-240, effective January 16, 1986.
3.35. Medical Adult Day Care Center -- An ambulatory health facility which provides an organized day program of therapeutic, social, and health maintenance and restorative services and whose general goal is to provide an alternative to twenty-four-hour long term institutional care to elderly or disabled adults who are in need of these services by virtue of physical and/or mental impairment.
3.36. Medical Diagnostic Machine -- A radiographic imaging system with one or more x-ray tubes used for human diagnostic imaging as defined in the bureau’s legislative rule, Radiological Health, 64CSR23, subsection 3.72. and subdivision 7.2.70., including mobile or fixed radiography, fluoroscopy, computerized tomography, bone density, podiatry, chiropractic, or other diagnostic x-ray devices.
3.37. Medical Therapeutic Machine -- A machine designed and used for external beam radiation therapy producing x-rays or electrons, as defined in the bureau’s legislative rule, Radiological Health, 64CSR23, paragraph 7.12.b.61. or particle accelerators used for human therapy as described in 64CSR23, subsection 3.4.
3.38. Municipal Sewer System -- A system or group of systems as a whole which receives sewage from more than one dwelling or establishment and is operated and maintained by an incorporated municipality, or public service district or sanitary board.
3.39. Nursing Home -- A nursing home as defined in W. Va. Code §16B-4-2.
3.40. Paternity Acknowledgement (Declaration of Paternity Affidavit) -- A legal instrument executed by an unmarried mother (or in some instances a married mother) and a putative father in which both acknowledge paternity of their child.
3.41. Permit -- As used in this rule, a written document issued by the Commissioner giving a designated person permission to:
3.41.1. Construct, operate, alter, or renovate a specific public water system, or bottled water production facility;
3.41.2. Construct, install, extend, alter, or operate an approved sewer system or method of sewage disposal, or to collect, remove, transport, or dispose of sewage;
3.41.3. Construct, alter, or renovate a recreational water facility or to operate the facility;
3.41.4. Construct, alter, operate, or renovate a food manufacturing facility;
3.41.5. Operate a food establishment at state facilities; or
3.41.6. Operate a state institution or state operated school, excluding colleges and universities.
3.42. Person -- An individual, partnership, association, syndicate, company, firm, trust, corporation, government corporation, institution, department, division, bureau, agency, federal agency, or any other entity recognized by law.
3.43. Presumptive Death Certificate -- A certificate of death prepared at the order of a county commission (or other appointed legal entities in other states) under the direction of W. Va. Code §44-9-1, et seq. which provides for the filing of a death certificate of someone presumed and declared dead by the commission.
3.44. Professional Health Services -- A health service delivered by a member of a commonly recognized public health care or allied profession including, but not limited to, physician, dentist, nurse, sanitarian, physical therapist, social worker, physician assistant, nurse practitioner, certified nurse midwife, dietitian, speech therapist, occupational therapist, hearing therapist, or individual with a graduate or undergraduate degree in a profession recognized by third party payors as eligible for reimbursement for services performed.
3.45. Public Sewer System -- A sewage collection system or systems with or without treatment facilities that service more than one dwelling or establishment. Ownership of the system is held by, and maintenance performed by, a single entity. This definition includes municipal sewer systems.
3.46. Public Water System -- A public water system as set forth in W. Va. Code §16-1-9a(a).
3.46.1. Community Water System -- A public water system which serves at least 15 service connections used by year-round residents or regularly serves at least 25 year-round residents.
3.46.2. Non-Community Non-Transient Water System -- Any public water system that is not a community water system and that regularly serves at least 25 of the same persons over six months per year.
3.46.2.a. Service Connection Equivalent -- The average number of individuals served by a non-community non-transient public water supply system divided by 2.4.
3.47. Radiation Machine Facility -- Any fixed or mobile facility with one or more radiation machines. (Radiation machines having one or more x-ray tubes.)
3.48. Radiation Producing Device -- A device or source of radiation as defined by the bureau’s legislative rule, Radiological Health, 64CSR23, subsection 3.72. (Radiation machines having one or more x-ray tubes.)
3.49. Radioactive Material.
3.49.1. Byproduct Radioactive Material [as in 64CSR23, subsection 3.16.] -- Accelerator produced material [as in 64CSR23, subsection 3.5.] or TENORM [as in 64CSR23, subdivision 16.3.g.], or
3.49.2. Non-byproduct Radioactive Material -- Any radioactive material, other than defined as byproduct material in the bureau’s legislative rule, Radiological Health, 64CSR23, subsection 3.16., which is TENORM or accelerator produced.
3.50. Radioactive Material Inspection -- Inspection of all activities associated with radioactive material registration.
3.51. Radioactive Material Facility Close-out Survey -- A confirmatory survey to assay for levels of radioactive contamination.
3.52. Reciprocity -- Reciprocal recognition for out-of-state registration or license to use a radiation-producing device or radioactive material within the State, as defined in the bureau’s legislative rule, Radiological Health, 64CSR23, subsections 5.11., 11.28., and 16.22.
3.53. Recreational Water Facility -- Any natural or artificial body or basin of water which is modified, improved, constructed, or installed for the purpose of public swimming or bathing under the control of any person.
3.54. Registration -- Registration of any radiation producing device or radioactive material used within the state, as defined in the bureau’s legislative rule, Radiological Health, 64CSR23, subsection 3.79. and section 5.
3.55. Residential Care Community -- A residential care community as defined in W. Va. Code §16B-9-2.
3.56. School Radon Testing -- The testing of radon levels in public school buildings in all major student-occupied areas at or below grade level in accordance with the Air Quality in New Schools Act, W. Va. Code §18-9E-3(b).
3.57. Sewage -- Any excreta or liquid waste containing animal, vegetable, or mineral matter in suspension of solution including, but not limited to, waste from water closets, urinals, lavatories, bathtubs, laundry tubs, washing machines, drinking fountains, sinks, kitchen equipment, and other sanitary fixtures or facilities.
3.58. Sewage Holding Tank -- A watertight receptacle designed and constructed to receive and retain untreated or partially treated sewage on a temporary basis. This does not include septic tanks, portable toilets, or privies.
3.59. Sewage System Installer Certification -- A process by which a person who installs individual on-site sewer systems becomes certified to perform such function under the provisions of the bureau’s legislative rule, Sewer Systems, Sewage Treatment Systems, and Sewage Tank Cleaners 64CSR9.
3.60. Shielding Plan -- Facility design or modification from a qualified expert of calculated barrier thickness and physical protection from sources of radiation for any fixed or mobile radiation machine, as described in the bureau’s legislative rule, Radiological Health, 64CSR23, subsection 7.4.
3.61. Sliding Fee Scale -- A charge for service that uses a scale or standard of cost, wages, fees, or the like that varies according to other factors such as cost of living, level of income, or prices.
3.62. Specimen Collection Kit -- A prepackaged group of items used for the acquisition and processing of material to be sent for analytical testing.
3.63. State Facilities -- Any of a number of state-owned and operated health care facilities including, but not limited to, state hospitals, behavioral health facilities, and other similar facilities. This term does not include colleges and universities.
3.64. State Institutions -- Any of a number of state-owned and operated residential or non-residential institutions including, but not limited to, juvenile detention centers, regional jails, correctional facilities, and state operated schools. This term does not include colleges and universities.
3.65. State Operated School -- Any of a number of state-owned and operated schools including, but not limited to, the School for the Deaf and Blind in Romney and the Barboursville School. This term does not include state colleges and universities.
3.66. Technologically Enhanced Naturally Occurring Radioactive Materials (TENORM) -- Naturally occurring radionuclides whose concentrations are increased by or as a result of past or present human practices.
3.67. Water Well -- Any excavation or penetration in the ground, whether drilled, bored, cored, driven, or jetted that enters or passes through an aquifer for purposes that may include, but are not limited to: a water supply, exploration for water, dewatering, or heat pump wells, except that this definition does not include groundwater monitoring activities and all activities for the exploration, development, production, storage, and recovery of coal, oil, and gas, and other mineral resources which are regulated under W. Va. Code, Chapters 22, 22A, or 22B.
3.68. Veterinary Machine -- Any radiation machine with at least one x-ray tube used by a licensed practitioner of veterinary medicine for diagnostic purposes on non-human subjects.
3.69. X-Ray Public Health Screening Application -- An application which is submitted for agency approval to conduct healing art screening as defined in the bureau’s legislative rule, Radiological Health, 64CSR23, paragraph 7.3.a.11., using diagnostic radiation machines within the state.
W. Va. Code R. § 64-51-4 Fees Generally
4.1. Authority to Assess and Collect Fees -- The Commissioner of the Bureau for Public Health may assess and collect fees for the provision of services. Except as specified in subsections 4.2. and 5.2. of this rule, the Commissioner may require payment of fees in advance for services. Where the Commissioner has staffed and equipped offices of the Bureau for Public Health to provide the services it is required to perform, the Commissioner may make efficient use of those resources by providing other public health services at reasonable fees established by the Commissioner.
4.2. Exemption from Fees Generally -- No individual may be denied health care services because of the inability of the individual to pay for services when services are provided to similarly situated individuals who have the ability to pay for them.
4.3. Fees for Copies of Public Records -- Copies of public records which may be disclosed shall be furnished at a charge of 50 cents per page on 8 ½” x 11” or 8 ½” x 14” paper. Copies of documents produced on larger paper may be furnished at actual cost, which includes, but is not limited to, materials, operator’s time, and transportation and delivery charges. Copying fees may be required to be paid for before issuance of the copies.
4.4. Fee for Location Information -- When the service provided is location information of licensees, permit holders, or other persons, the fee shall be at the rate of 25 cents per location.
W. Va. Code R. § 64-51-5 Laboratory Service Fees
5.1. Laboratory Services for Which a Fee May be Charged -- Except as provided in subsection 5.2. of this rule, the Commissioner may charge a fee for each test or group of tests, including specimen collection kits, as listed in Appendix A of this rule. The laboratory may charge for bacteriological and chemical analyses of environmental water samples, clinical specimens, and for the certification of laboratories to conduct drinking water tests.
5.2. Exemption from Laboratory Fees -- Fees shall not be charged when:
5.2.1. Laboratory tests are authorized by the Commissioner as part of an epidemiological investigation, or the charging of the fee would significantly and adversely affect the public health;
5.2.2. Tests on second or additional specimens are required by the Commissioner because of the inability to make or complete a test, or because the testing operation or procedure is unsatisfactory for any reason;
5.2.3. Specimens are determined to be unsatisfactory for testing at the time of submission; or
5.2.4. The exemption from fees provision of subsection 4.2. of this rule applies.
W. Va. Code R. § 64-51-6 Environmental Health Fees
6.1. The Commissioner may charge a fee for each environmental health service listed in Appendix B of this rule.
W. Va. Code R. § 64-51-7 Health Facility Fees
7.1. The Department may charge a fee for each service provided to health facilities listed in Appendix C of this rule. The Office of Health Facility Licensure and Certification is under the auspices of the Office of the Inspector General (OIG). When a new rule is promulgated to replace this one with respect to Health Facility Licensure and Certification, the facility definitions in section 3 of this rule and the fee provisions in Appendix C of this rule, will be repealed.
W. Va. Code R. § 64-51-8 Health Statistics Center Fees
8.1. The Commissioner may charge a fee for each service provided as listed in Appendix D of this rule: Provided that the state registrar may furnish services to state agencies and to organized charities, free of charge, when the services are required before presenting claims to the federal government, or to the state for public assistance, and; provided further, that the state registrar shall make an accurate record of all services provided for the above purposes.
W. Va. Code R. § 64-51-9 Administrative Due Process
9.1. Those persons adversely affected by the enforcement of this rule desiring a contested case hearing to determine any rights, duties, interests, or privileges shall do so in a manner prescribed in the Rules of Procedure for Contested Case Hearings and Declaratory Rulings, 64CSR1.
Appendix A 64CSR51. Laboratory Service Fees.
Fees for Environmental Chemistry Laboratory Services Inorganic Chemicals/Miscellaneous Tests Metals Analyses for each metal:
Analyses may include but are not limited to, arsenic, barium, beryllium, cadmium, thallium, chromium, nickel, lead, antimony, manganese, selenium, silver, sodium, aluminum, zinc, and copper.
Metals Regulatory Package - (Parameters divided into EPA regulated groups)
Analyses may include, but are not limited to, antimony, arsenic, barium, beryllium, cadmium, chromium, mercury, nickel, thallium, selenium, and sodium. $60 Metals Secondary Package - (Parameters divided into EPA regulated groups)
Analyses may include, but are not limited to, aluminum, iron, magnesium, manganese, silver, and zinc $45 Metals Lead and Copper - (20% discount when ordered together as a package) $32 Mercury by cold vapor $25 Analytes by ion chromatography (IC)
Analyses for each anion: Analyses may include, but are not limited to, fluoride, chloride, chlorite, chlorate, sulfate, nitrate, nitrite, ortho-phosphate, bromide, and bromate.
Anions Package (a) (Instrument is capable of performing all tests within a single run) Analyses may include, but are not limited to, fluoride, chloride, nitrate, nitrite, ortho-phosphate, and sulfate.
Analytes by ion selective electrode Analyses may include, but are not limited to, fluoride and pH.
Miscellaneous Individual Tests Alkalinity (Total) As CaC03 Calcium by Titration Calcium Hardness Chloramines Chlorine, Free Chlorine, Total Conductivity Dissolved Solids, Total $13 Hardness, Total $10 Hydrogen Sulfide $10 Magnesium by Titration Foaming Agents Nitrate Nitrate + Nitrite Orthophosphate Phosphate, Total $16 Silica Turbidity (NTU)
Cyanide $25 Nitrite Wet Chemistry Package Analyses may include, but are not limited to, alkalinity, calcium, calcium hardness, pH, total dissolved solids, and total hardness.
Inorganic non-Routine Analysis Organic Compounds (Fees Include Sample Preparation)
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EPA Regulated Volatile Compounds (VOCs) $125 2. EPA Unregulated Contaminants per Method Group (Description is applicable to the EPA unregulated contaminant monitoring rule which is categorized by contaminants in a method group - http://water.epa.gov/lawsregs/rulesregs/sdwa/ucmr/ucmr3/methods.cfm)
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EPA Regulated Synthetic Organic Compounds (SOCs):
Organohalide and Polychlorinated Biphenyl Packages $185 Pesticides Package (a)
Analyses may include, but are not limited to, Endrin, Lindane, Heptachlor, Heptachlor epoxide, Methoxychlor, Hexachlorobenzene, and Hexachlorocyclopentadiene Pesticides Package (b)
Analyses may include, but are not limited to, Chlordane, Simazine, and Toxaphene Pesticides Package (c)
Analyses may include, but are not limited to, PCB (Aroclor) 1016, 1221, 1232, 1242, 1248, 1254, and 1260 Nitrogen-Phosphorous Pesticide Package Analyses may include, but are not limited to, Alachlor, Atrazine, and Simazine Carbamate Pesticides Package Analyses may include, but are not limited to, Aldicarb, Aldicarb Sulfone, Aldicarb Sulfoxide, Carbofuran, and Oxamyl (Vydate)
Diquat Endothall Glyphosate Esters Package Analyses may include, but are not limited to, Di (2-ethylhexyl) Adipate and Di (2-ethylhexyl) Phthalate Benzo (a) pyrene Herbicides Package Analyses may include, but are not limited to, 2,4-D, 2,4,5 - TP (Silvex), Pentachlorophenol, Dinoseb, Dalapon, and Picloram $175 1,2-Dibromoethane (EDB) and 1,2-Dibromo-3-Chloropropane (DBCP)
- Disinfection By Products Trihalomethanes (THMs) Package Analyses may include, but are not limited to, Bromoform, Chloroform, Bromodichloromethane, and Chlorodibromomethane Haloacetic Acids (HAAs) Package Analyses may include, but are not limited to, Bromoacetic Acid, Chloroacetic Acid, Dibromoacetic Acid, Dichloroacetic Acid, and Trichloroacetic Acid $190 Trihalomethanes and Haloacetic Acids Package $184 DBP Anions Package Analyses may include, but are not limited to, bromate, bromide, chlorate, and chlorite.
EPA Regulated Organics Package, includes Pesticides, PCBs, Carbamates, Diquat, Endothall, and Glyphosate $845 Other Organic Tests: * Raw and/or Finished *Total Organic Carbon (TOC) $40 b. *Specific Ultraviolet Absorption (SUVA)
Organic non-Routine Analysis Harmful Algae Bloom (HAB)
a. Screening analyses for each individual toxin: Analyses may include, but are not limited to, Microcystin, Cylindrospermopsin, Anatoxin-a, Saxitoxin, and b-Methylamino-L-alanine. $65 b. Confirmation of each individual toxin: Analyses may include, but are not limited to, Microcystin, Cylindrospermopsin, Anatoxin-a, Saxitoxin, and b-Methylamino-L-alanine. $65 Fees for Environmental Microbiology Laboratory Service Coliform Test $18 Container Rinse Test Heterotrophic Plate Count $18 D. Legionella $36 3. Sample Processing Fee Standard $5 Special handling and packaging (A sample processing fee will be charged for each sample submitted to the OLS for testing with the exception of samples for Fluoride.)
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Fee for Chain of Custody 5. Fees for Certification of Laboratories to Conduct Drinking Water Tests: Certification to perform laboratory testing on water to meet state and Environmental Protection Agency requirements under the Safe Drinking Water Act. * Chemical Testing:
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Inorganic Tests Trihalomethanes and Volatile Organic Compounds and Haloacetic Acids Herbicides Pesticides and Synthetic Organic Chemicals All Other Organic Tests Microbiological Testing New lab application fee (nonrefundable)
Issuance of an updated certificate (for dropped, added, or change of status)
Fee for follow-up on-site audit *Laboratories located outside the borders of West Virginia will be assessed the certification fee for the tests approved and shall pay all reasonable expenses required for an on-site inspection.
- Fees for Specimen Collection Kits:
Blood Lead 7. The State Hygienic Laboratory may enter into contractual agreements for providing services at a negotiated rate for testing specimens in the conduct of Public Health Investigations, Public Health Interventions, and Public Health Risk Assessments.
- In order to maintain preparedness and assess threats the Lab may charge for testing related to terrorism.
Bioterrorism A reasonable fee established by the Commissioner may be charged in the testing of specimens for the detection of the presence of agents of bioterrorism. Testing may include, but is not limited to, the detection of biological agents causing anthrax, plague, tularemia, botulism, brucellosis, Q fever, or any other suspected agent.
Chemical Terrorism The Commissioner may charge a reasonable fee, based upon an itemization of costs, for the testing of specimens for detection of the presence of agents of chemical terrorism. Testing may include, but is not limited to, the detection of chemical agents such as ricin, cyanide, or any other suspected agent.
- Fees for Diagnostic Immunology Syphilis tests $21.91 Rubella antibody $14.39 HIV Screening – Serum (screening and confirmation if necessary) $46.49 Hepatitis A IgM Test $11.26 Hepatitis B Screen with reflex testing $44.89 Hepatitis SAB (Post Vaccine) $10.74 Hepatitis C Antibody Screen $29.76 Hepatitis C Confirmation NAA Test $15.49 Respiratory panel $567.18 Gastrointestinal panel $567.18 QuantiFERON $84.35 GeneXpert for TB $47.76 Whole Genome Sequencing $125 Chlamydia/Gonorrhea NAA Test $70.18 Rabies SARS Covid-19 NAA Test $51.31 M. genitalium NAA Test $35.09 Trichomoniasis NAA Test $35.09
Appendix B 64CSR51. Environmental Health Services Fees.
- Water Systems, Sewage Systems and Recreational Water Facilities Construction/Installation Permits and License Public Water System Project Public Sewer System or Facility Project Public Swimming Pool/Recreational Water Facility Project Sewage Holding Tank $1000 On-Site Innovative/Alternative Type Sewage System a. Correcting Failure b. New Construction 6. Sewage System Installer Certification and Renewal B. Water Well Permits (New Construction) Public Water System 2. Bottled Drinking Water/Water Vending Machine Permits A. Distributors, Annually B. Producers and Distributors, Annually, Facility Size (based on Gross Sales) $0 to $7,499 $35 $7,500 to $14,999 $15,000 to $24,999 $25,000 to $49,999 $50,000 to $99,999 $100,000 to $499,999 $500,000 to $999,999 $1,000,000 to $4,999,999 $600 $5,000,000 to $9,999,999 $700 $10,000,000 to $24,999,999 $800 $25,000,000 to $49,999,999 $900 Greater than $50,000,000 3. Radiological Registration A. Business (or Individual) Providing Vendor Services B. Radioactive Material C. Radiation Machine Facility (initial or renewal)
D. Reciprocity E. X-ray Public Health Screening Application 4. Radiological Inspection A. Decommissioning B Dental Intraoral Machine per Tube $80 C. Dental Panoramic Machine per Tube $80 D. Dental (Other than intraoral or panoramic) per Tube E. Emergency Services Consultation $100 per hour F. Industrial Cabinet X-ray System per Tube G. Industrial High Energy Machine per Tube $120 H. Industrial Radiographic Machine per Tube I. Industrial Radiation Machine (Other) per Tube J. Medical Diagnostic Machine per Tube K. Medical Therapeutic Machine per Tube L. Radiation Machine per Tube (Other than Diagnostic or Therapeutic Machines, used for research or other purposes)
M. Radioactive Material Facility Close-out Survey $120 N. Radioactive Material Inspection $170 O. Shielding Plan Review P. Veterinary Machine per Tube 5. Asbestos Abatement A. Training Accreditation 1. Course Approval Per discipline/maximum $1,000/$3,000 2. Review Course Approval B. Notification – Inspection of Projects 1. Class I: 10-100 linear ft. or 50-200 sq. ft.
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Class II: more than 100 and less than or equal to 1000 linear ft. or more than 200 and less than or equal to 2000 sq. ft.
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Class III: greater than 1000 linear ft. or greater than 2000 sq. ft. $700 4. Class IV: Annual Industrial Facility $2,000 6. Annual Low-Level Radioactive Waste Generator or Storage Fee $12,500 7. TENORM Processing and Storage A. Registration 1. Initial Plan Review $5,000 2. Approved Plan Revision $2,500 3. Registration $3,000 4. Proof of Financial Surety Minimum of $1,000,000 8. School Radon Testing A. Test fee per sampling point $17.50 B. Bureau staff time per hour $25 9. Food Manufacturing Facility Permit (Annual, Expires 6-30)
Facility Size (measured in Gross Sales)
A. $0 to $7,499.99 $35 B. $7,500 to $14,999.99 C. $15,000 to $24,999.99 D. $25,000 to $49,999.99 E. $50,000 to $99,999.99 F. $100,000 to $499,999.99 G. $500,000 to $999,999.99 H. $1,000,000 to $4,999,999.99 $600 I. $5,000,000 to $9,999,999.99 $700 J. $10,000,000 to $$24,999,999.99 $800 K. $25,000,000 to $49,999,999.99 $900 L. Greater than $50,000,000 10. Food Manufacturing Plan Review Fee A. New or Remodeled Facility Size 1-4 B. New or Remodeled Facility Size 5-8 C. New or Remodeled Facility Size 9-12 11. Food Establishment Permits at State Facilities (Annual, Expires 6-30)
A. Seating Capacity 1. 0-20 seats 2. 21-50 seats 3. 51-80 seats 4. 81 and over seats 11. State Institution Permits (Annual, Expires 6-30)
A. Juvenile Detention Centers, by capacity 1. 0-25 2. 26-50 3. 51-75 4. 76 and over $125 B. Juvenile Correctional Centers 1. 0-25 2. 26-50 $75 3. 51-75 4. 76 and over $125 C. Correctional Center and/or Jail (Regional) by capacity 1. 0-200 201-400 3. 401-600 4. 601 and over D. Work Camp by capacity 1. 0-50 2. 51-100 11. State Operated Schools (Does not include Colleges and Universities)
Appendix C 64CSR51. Health Facility Fees.
- Site Inspections for New Construction or Major Renovation Hospitals $475 Ambulatory Surgical Facility Nursing Homes $475 Assisted Living Residence Residential Care Community Behavioral Health Center Locations Medical Adult Day Care Centers 2. Architect's Review of Plans Hospitals New Hospitals and Major Additions $850 Ambulatory Surgical Centers Nursing Homes New Home and Major Additions $750 Assisted Living Residence - 17 beds and larger New Home and Major Additions Assisted Living Residences 4 - 16 beds New Homes and Major Additions Residential Care Community Behavioral Health Center Group Homes End Stage Renal Disease (ESRD)
Hospice New Hospice and Major Additions Birthing Center Overtime Review Requested by Facility (per hour)
Medical Adult Day Care 3. Building Inspection of New Projects Prior to Opening Hospitals New Hospitals and Major Additions $850 Ambulatory Surgical Facility Nursing Homes New Home and Major Additions $750 Behavioral Health Center Group Homes End Stage Renal Disease (ESRD)
Hospice New Hospice and Major Additions $650 Birthing Center Medical Adult Day Care Centers Assisted Living Residences
Appendix D 64CSR51. Health Statistics Center Fees.
- Fees for services:
A. Preparation of a new certificate of birth due to adoption or legitimation. This does not include one certified copy.
No Charge B. Amendment of a certificate following a legal name change by court order. This does not include one certified copy. $10 C. Amendment of a certificate subsequent to acceptance of a child support enforcement order or a court ordered determination of paternity. This does not include a certified copy.
No Charge D. Amendment of a birth certificate after acceptance of a paternity acknowledgment. This does not include a certified copy.
No charge within 1 year of birth $10 after the 1st year E. Preparing and filing a delayed certificate of birth or death. This does not include one certified copy.
F. Additional handling charge for non-routine, expedited service and all special delivery, priority, or express mail that requires special attention. Express shipping charges extra at cost. $5 for regular mail $10 for next day service G. Preparing and filing a presumptive death certificate. This does not include one certified copy.
No Charge H. Amending a birth or death certificate. This does not include one certified copy.
No charge within one year of event $10 after the 1st year of event I. Manually preparing an abstracted document from the original on file for certification, upon demand by the customer. This does not include a certified copy of the abstracted certificate. $10 K. A fee may be charged for special services not specified in this Appendix. The fee shall be the actual cost for providing the service as determined by the State Registrar.
L. The State Registrar may waive a fee for service for good cause, including requests from legitimate charities and those on behalf of indigent persons.
Series 56 Infectious Medical Waste
W. Va. Code R. § 64-56-1 General
1.1. Scope. This legislative rule establishes requirements regarding the generation, handling, storage, transportation, treatment and disposal of infectious medical waste.
1.2. Authority. -- W. Va. Code §§ 16-1-4, 20-5J-6(a) and 22-18-7(d). Related - W. Va. Code §§ 20-5J-1, et. seq., 20-5K-1, et. seq., and 22-18-1, et. seq.
1.3. Filing Date. -- April 28, 2016
1.4. Effective Date.
July 1, 2016
W. Va. Code R. § 64-56-2 Applicability; Exemptions; Enforcement
2.1. Applicability.
This rule applies to: any person who generates, handles, stores, transports, treats or disposes of infectious medical waste, or who proposes to do so, except as specified in Section 2.2. of this rule.
2.2. Exemptions.
2.2.a. Individual households in which infectious medical waste is generated by a member of the household during self health care or by the provision of health care services within the residence shall be exempt from the requirements of this rule, except that the householder shall place sharps in a container with a high degree of puncture resistance prior to discarding them.
2.2.b. Ambulance or rescue services shall be exempt from the requirements of this rule, except that all infectious medical waste generated in an ambulance or rescue vehicle shall be packaged as required by Section 6.2 of this rule and delivered to a permitted infectious medical waste management facility.
2.3. Enforcement. This rule is enforced by the Secretary of the Department of Health and Human Resources.
W. Va. Code R. § 64-56-3 Definitions
3.1. Animal Carcasses, Body Parts, Bedding and Related Wastes. -- Any animal carcasses, body parts, and bedding of animals that are known to have been exposed to infectious agents during research, production of biologicals, testing of pharmaceuticals, or for any other reason.
3.2. Blood and Blood Products. -- Liquid waste human blood and blood products in a freeflowing or unabsorbed state.
3.3. Commercial Infectious Medical Waste Management Facility. -- Any infectious medical waste management facility at which thirty-five per cent (35%) or more by weight of the total infectious medical waste stored, treated, or disposed of by said facility in any calendar year is generated off-site.
3.4. Cultures and Stocks of Microorganisms and Biologicals. -- Discarded cultures, stocks, specimens, vaccines and associated items likely to have been contaminated by an infectious agent, discarded etiologic agents, and wastes from the production of biologicals and antibiotics likely to have been contaminated by an infectious agent.
3.5. Disposal. -- The discharge, deposit, injection, dumping, spilling, leaking or placing of any infectious medical waste into or on any land or water so that such infectious medical waste, or any constituent thereof, may be emitted into the air, discharged into any waters, including groundwater, or otherwise enter into the environment. (See Section 5.7 of this rule.)
3.6. Generator. -- Any person whose act or process produces infectious medical waste.
3.7. Hazardous Waste .-- Waste as defined in W.Va. Code § 22-18-3(6) and Hazardous Waste Management System Rule (33 CSR 20).
3.8. Hospital. -- An institution which is primarily engaged in providing to patients in the institution, by or under the supervision of physicians, diagnostic and therapeutic services for medical diagnosis, treatment and care of injured, disabled or sick persons or services for the rehabilitation of injured, disabled or sick persons. This term also includes psychiatric and tuberculosis hospitals.
3.9. Infectious Agent. -- Any organism such as a virus or bacteria that is in such quantity that it is capable of being communicated by invasion of and multiplication in body tissues and capable of causing disease or adverse health impact in humans.
3.10. Infectious Medical Waste. --
3.10.a. Infectious medical waste is medical waste which is capable of producing an infectious disease. Medical waste shall be considered capable of producing an infectious disease if it has been, or is likely to have been, contaminated by an organism likely to be pathogenic to healthy humans, if such organism is not routinely and freely available in the community, and such organism has a significant probability of being present in sufficient quantities and with sufficient virulence to transmit disease.
3.10.b. For the purposes of this rule, infectious medical waste includes the following materials:
3.10.b.1. Cultures and stock of microorganisms and biologicals;
3.10.b.2. Blood and blood products;
3.10.b.3. Pathological wastes;
3.10.b.4. Sharps;
3.10.b.5. Animal carcasses, body parts, bedding and related wastes;
3.10.b.6. Isolation wastes;
3.10.b.7. Any residue or contaminated soil, water, or other debris resulting from the cleanup of a spill of any infectious medical waste; and
3.10.b.8. Waste contaminated by or mixed with infectious medical waste.
3.10.c. For the purposes of this rule, infectious medical waste does not include the following materials:
3.10.c.1. Human remains and body parts being used or examined for medical purposes which are under the control of a licensed physician or dentist and are not abandoned materials;
3.10.c.2. Human remains lawfully interred in a cemetery or in preparation by a licensed mortician for interment or cremation;
3.10.c.3. Used personal hygiene products, such as diapers, facial tissues and sanitary napkins;
3.10.c.4. Gauze and dressing material, containing small amounts of blood or other body secretions with no free flowing or unabsorbed liquid;
3.10.c.5. Hair, nails, and extracted teeth;
3.10.c.6. Waste generated by veterinary hospitals, except for waste meeting the criteria found in Sections 3.10.b.1, 3.10.b.4, or 3.10.b.5 of this rule; and
3.10.c.7. Medical tubing and devices with a signed and dated certification by the facility which states: "I hereby certify under penalty of law that this waste has not been contaminated with infectious medical waste, as defined in Infectious Medical Waste, 64CSR56."
3.10.d. Infectious medical waste contaminated with radioactive waste is considered to be radioactive waste and is subject to State and federal law and regulation as radioactive waste.
3.10.e. Infectious medical waste:
3.10.e.1. Which demonstrates the characteristics of ignitability, corrosivity, reactivity, or toxicity as defined in 40 C.F.R. Part 261, Subpart C, or which is contaminated with RCRA hazardous waste listed in 40 CFR Part 261, Subpart D is considered to be hazardous waste and is subject to regulation under State and federal hazardous waste. W. Va. Code § 22-18-1, et seq., W.
Va. Code R. §§ 33-20-1, et seq., and 45-25-1, et seq., and 40 C.F.R. Parts 260 - 279.
3.10.e.2. Which is contaminated with a hazardous waste listed in 40 C.F.R. Part 261, Subpart D that is listed solely because it exhibits one or more characteristics of ignitability, corrosivity, or reactivity as defined under 40 C.F.R. Part 261 Subpart C, is not a hazardous waste if the waste no longer exhibits any characteristic of hazardous waste identified in that subpart.
3.11. Infectious Medical Waste Management Facility. -- An infectious medical waste facility which generates, handles, processes, stores, treats or disposes of infectious medical waste, including all land and structures, other appurtenances, and improvements thereon, used for infectious medical waste.
3.12. Isolation Wastes. -- Wastes generated from the care of a patient who has or is suspected of having any disease listed as Class IV in "Classification of Etiologic Agents on the Basis of Hazard," published by the United States Centers for Disease Control.
3.13. Manifest or Shipping Document. -- The written or electronic documents used for identifying the quantity, composition, and the origin, routing, and destination of infectious medical waste during its transportation from the point of generation to the point of off-site treatment or disposal.
3.14. Medical Waste. -- Infectious and noninfectious solid waste generated in the course of the diagnosis, treatment or immunization of human beings or animals, or in research pertaining thereto, or in the production or testing of biologicals. The term "medical waste" does not include low-level radioactive waste, any hazardous waste identified or listed under Subtitle C of the federal Resource Conservation and Recovery Act of 1976, 42 U.S.C. § 6921 et seq., as amended, or any household waste as defined in the regulations promulgated pursuant to Subtitle C of that Act.
3.15. Non-commercial Infectious Medical Waste Management Facility. -- Any infectious medical waste facility at which less than thirty-five per cent (35%) by weight of the total infectious medical waste stored, treated or disposed of by said facility in any calendar year is generated off-site.
3.16. Noninfectious Medical Waste. -- Any medical waste not capable of producing an infectious disease or infectious medical waste which has been rendered noninfectious. Noninfectious medical waste is considered solid waste for purposes of this rule.
3.17. Off-Site. -- A facility or area for the collection, storage, transfer, processing, treatment, or disposal of infectious medical waste which is not on the generator's site, or a facility or area that receives infectious medical waste for storage or treatment that has not been generated on-site at that facility or area.
3.18. On-Site. -- The same or geographically contiguous property which may be divided by a public or private right-of-way, provided the entrance and exit between the properties is at a crossroads intersection, and access is by crossing, as opposed to going along, the right-of-way. Noncontiguous properties owned by the same person but connected by a right-of-way controlled by said person and to which the public does not have access, is also considered on-site property. Hospitals with more than one (1) facility located in the same county shall be considered one (1) site.
3.19. Pathological Waste. -- Human pathological wastes, including tissues, organs, body parts, and containers of body fluids, exclusive of those fixed in formaldehyde or another fixative.
3.20. Person. -- Individual, partnership, corporation, society, association, government body or other legal entity.
3.21. Secretary. -- The Secretary of the Department of Health and Human Resources or his or her designee.
3.22. Sharps. -- Discarded articles that may cause punctures or cuts and that have been used in animal or human patient care or treatment, or in pharmacies or medical, research or industrial laboratories, including, but not limited to, hypodermic needles, syringes with attached needles, scalpel blades, lancets and broken glassware.
3.23. Small Quantity Generator. -- Any generator of infectious medical waste who generates fifty (50) pounds or less during a one (1) month period.
3.24. Storage. -- The containment of infectious medical waste on a temporary basis. Storage shall not constitute disposal of the waste. The containment of infectious medical waste during offsite transport is considered to be a form of storage.
3.25. Subtitle C. -- Subtitle C of the federal Resource Conservation and Recovery Act of 1976, 42 U.S.C. § 6921 et seq., as amended.
3.26. Transport. -- The movement of infectious medical waste from one location to another, except for on-site movement of infectious medical waste.
3.27. Transporter. -- A person engaged in the off-site transportation of infectious medical waste.
3.28.Transport Vehicle. -- A motor vehicle, aircraft, boat, barge or rail car used for the transportation of cargo by any mode. Each cargo-carrying body shall be considered a separate transport vehicle.
3.29. Treatment. -- Any method, technique or process, including neutralization, designed to change the physical, chemical or biological character or composition of any infectious medical waste so as to render such waste noninfectious.
3.30. "Waste" -- Any garbage, refuse, sludge from a waste treatment plant, water supply treatment plant or air pollution control facility and other discarded material including solid liquid, semisolid or contained gaseous material resulting from industrial, commercial, mining and agricultural operations and from community activities, but does not include solid or dissolved material in domestic sewage, or solid or dissolved materials in irrigation return flows or industrial discharges which are point sources subject to permits under Section 402 of the federal Water Pollution Control Act, as amended, or source, special nuclear or by-product material as defined by the federal Atomic Energy Act of 1954, as amended.
W. Va. Code R. § 64-56-4 Permit Application and Approval Procedures for Non-Commercial Infectious Medical Waste Management Facilities
4.1. This section applies only to non-commercial infectious medical waste facilities. No person may own, construct, modify or operate an infectious medical waste management facility, nor shall any person store, transport, treat or dispose of any infectious medical waste without first obtaining a permit from the Secretary, unless exempted by Sections 2.1., 2.2. or 4.17. of this rule.
4.2. No person shall begin physical construction of a new non-commercial infectious medical waste management facility without having received a permit.
4.3. The owner of a non-commercial infectious medical waste management facility shall be responsible for insuring that the facility has a permit.
4.4. The owner of an infectious medical waste facility shall provide public notice of intent to apply for a permit.
4.4.a. Public notice shall be given by any method reasonably calculated to give actual notice of the action in question to the persons potentially affected by it, including press releases or any other forum or medium to elicit public participation.
4.5. The applicant for a permit for a non-commercial infectious medical waste facility shall maintain a public participation file. This file shall contain a summary of all comments and responses received during the pre-application public notification phase by the facility. This file shall be submitted to the Secretary by the applicant with the application.
4.6. An application for a permit shall be submitted to the Secretary on forms prescribed by the Secretary and shall include the following:
4.6.a. The name, mailing address, and location of the facility, using latitude and longitude to the nearest second, for which the application is submitted;
4.6.b. The name, mailing and email addresses and telephone numbers of the owner of the facility;
4.6.c. The name, mailing and email addresses and telephone numbers of the manager of the facility, if different from the owner;
4.6.d. A copy of the proposed infectious medical waste management plan as required by
Section 5 of this rule;
4.6.e. A copy of the public participation file; and
4.6.f. Information needed to demonstrate that the facility will be operated in compliance with this rule.
4.7. For new non-commercial infectious medical waste management facilities, the application shall be accompanied by a copy of a topographic map or equivalent showing the facility and the area one thousand (1,000) feet around the facility site with the following information included:
4.7.a. The map scale and date;
4.7.b. Land uses (e.g. any established zoning for residential, commercial, agricultural, recreational, industrial or other designated uses);
4.7.c. The orientation of the map (north arrow);
4.7.d. The legal boundaries of the facility with the latitude and longitude to the nearest second for the site;
4.7.e. Access control (fences, gates); and
4.7.f. Buildings to be used for treatment, storage, and disposal operations and other structures (e.g. recreation areas, run-off control systems, access and internal roads, storm, sanitary, and process sewerage systems, loading and unloading areas, fire control facilities).
4.8. The Secretary shall not begin the evaluation of a permit before receiving a complete application, as determined by the Secretary. Within thirty (30) days of the Secretary's receipt of a permit application, the completeness of the application shall be judged independently of the status of any other permit application or permit for the same facility or activity.
4.9. The Secretary shall not issue a permit before receiving a complete application.
4.10. The Secretary shall have the authority to request supplemental information needed to demonstrate that the facility will be operated in compliance with this rule.
4.11. When the Secretary determines an application for a new non-commercial infectious medical waste facility or a major change to an existing facility to be complete, he or she shall instruct the applicant or permittee to give public notice.
4.11.a. Public comment shall be conducted in accordance with the following guidelines:
4.11.a.1. Public notice shall be given by publishing the public notice as a Class II legal advertisement in a qualified newspaper, as defined in W. Va. Code § 59-3-1, serving the county where the facility will be located. That legal advertisement shall also be placed in newspapers of adjacent counties when a proposed facility is within two (2) miles of a county line. The cost of the publication will be the responsibility of the applicant who shall send a certification of publication to the Secretary within twenty (20) days after publication; and any other method reasonably calculated to give actual notice of the action in question to the persons potentially affected by it, including press releases or any other forum or medium to elicit public participation.
4.11.a.2. All public notices issued shall contain the following information:
4.11.a.2.A. The name and mailing and email addresses of the office processing the permit action for which notice is being given;
4.11.a.2.B. The name and mailing and email addresses of the permittee or permit applicant, and if different, of the facility or activity regulated by the permit;
4.11.a.2.C. A description of the activities covered in the application, including the type of technology that will be used to treat infectious medical waste, the types, amounts, and origins of infectious medical waste to be handled, site improvements, and infectious medical waste handling methods;
4.11.a.2.D. The name, mailing and email addresses, and telephone numbers of a person from whom interested persons may obtain further information;
4.11.a.2.E. A general description of the location of the proposed permit area including streams;
4.11.a.2.F. A clear and accurate location map. A map of a scale and detail found in the West Virginia official state highway map is the minimum standard for acceptance. The map size shall be at a minimum two (2) inches by two (2) inches. Longitude and latitude lines and a north arrow shall be indicated on the map, and such lines will cross at or near the center of the proposed permit area;
4.11.a.2.G. A reference to the date of previous public notices relating to the permit;
4.11.a.2.H. That any interested person may submit a written comment on the application, and that such comments shall include a concise statement of the nature of the issues raised;
4.11.a.2.I. That any interested person may submit a written request for a public hearing, and that such request shall include a concise statement of the nature of the issues raised; and
4.11.a.2.J. That the Secretary shall conduct a public hearing within forty-five (45) days in the county where the proposed facility is to be located whenever he or she receives a request.
4.11.a.3. The availability of the application shall include, but not be limited to, copies placed at the courthouse of the county in which the facility is to be located, the city or town hall of any municipal government within two (2) miles of the proposed location of the facility, and the primary public library in the county.
4.11.a.4. Copies of the application shall be available from the Secretary.
4.11.b. If any data, information or arguments submitted during the public comment period raise substantial new questions concerning the proposed major change or new facility, the Secretary shall:
4.11.b.1. Request additional information from the applicant; and
4.11.d.1.A. Reopen or extend the public comment period for thirty (30) days to give interested persons an opportunity to comment on the information or argument submitted; or
4.11.d.1.B. Require a public hearing.
4.11.c. In the event a public hearing is held:
4.11.c.1. Public notice of the hearing shall be given by the Secretary at least thirty (30) days before the hearing;
4.11.c.2. A transcript of the hearing shall be available to the public from the Secretary;
4.11.c.3. At the hearing, any person may make oral comments and submit written statements and data concerning the proposed major changes or new facility. Reasonable limits may be set on the time allowed for oral statements, and the written statements shall be submitted to the Secretary no later than ten (10) days after the close of the hearing; and
4.11.c.4. The Secretary shall act on the permit application within thirty (30) days after the date for the submission of written statements to the Secretary.
4.11.d. In the event a public comment period is held, the Secretary shall act on the permit application within thirty (30) days after the close of the comment period.
4.12. Permits shall be renewed annually prior to expiration. An application for permit renewal shall be submitted thirty (30) days prior to the expiration date of the previous permit. A late fee of 25% for all expired permits listed in this rule will be applied to the permit fee schedule. Payment must be received within 15 days of the expiration date to avoid the late fee assessment.
4.13. An application for an original or renewal permit shall be accompanied by a non-refundable permit fee according to the schedule shown in Table 64-56A found at the end of this rule.
4.14. A permit shall be issued if the facility is, or in the case of a projected facility, is planned to be, in compliance with the applicable provisions of this rule and has submitted the permit fee.
4.15. The Secretary may refuse to grant or renew a permit if an applicant or permittee has attempted to obtain a permit by means of fraud, deceit or material misrepresentation or public comment reveals a situation which would endanger public health.
4.16. A permittee shall submit an application for approval of a major change in the permittee's infectious medical waste management plan before implementing the change. Minor changes in the infectious medical waste plan may be made without notifying the Secretary and shall be included in the next application for permit renewal. All major changes shall be approved prior to implementation: Provided, That, no prior approval is necessary in the case of a hospital which may in an emergency make an immediate change in its plan necessary to protect the safety and care of patients, employees or the public. In such an event, the hospital shall notify the Secretary immediately followed by written notification within fifteen (15) days. An application for approval of any change in the plan which is beyond the control of the permittee shall be submitted within fifteen (15) days of its occurrence. A major change consists of any of the following:
4.16.a. Installing a new unit for the treatment of infectious medical waste or replacing existing units not including improvements, as determined by the Secretary, or repairs to existing units;
4.16.b. Changing the location of treatment; or
4.16.c. Permanently increasing the volume of infectious medical waste by at least twenty percent (20%), if the amount of the increase is fifty (50) pounds or more.
4.17. Small quantity generators who generate infectious medical waste in the provision of health care services in their own office are not required to obtain a permit. Small quantity generators shall keep their infectious medical waste management plan on file and shall make a copy available to the Secretary on request.
4.18. Permits issued by the Secretary for a non-commercial infectious waste facility are not transferable or assignable and shall automatically become invalid upon a change of ownership or upon suspension or revocation. An existing large quantity generator that changes ownership, however, may continue to operate under the previous owner's permit conditions until such time as the Secretary can process the new permit application required by this section, provided the new owner sends the Secretary a letter in which the new owner:
4.18.a. Advise the Secretary of any change of ownership including any management changes; and
4.18.b. Agree to be bound by the conditions and policies established in the infectious medical waste management plan for that facility by the previous owner until such time as a new management plan can be approved by the Secretary.
W. Va. Code R. § 64-56-5 Infectious Medical Waste Management Plan
5.1. All infectious medical waste management facilities shall develop an infectious medical waste management plan.
5.2. The infectious medical waste management plan shall set forth policies and procedures for managing infectious medical waste which are consistent with this rule and shall include, at a minimum, the following:
5.2.a. A projection of the weight of the infectious medical waste which will be generated monthly;
5.2.b. A description of infectious and noninfectious medical waste handling, storage, separation and volume-reduction procedures;
5.2.c. The methods which will be used to treat the infectious medical waste;
5.2.d. Transportation method;
5.2.e. Manifest systems or shipping documents and labeling;
5.2.f. Disposal methods consistent with Section 10.4 of this rule;
5.2.g. The name, mailing and email addresses, and telephone numbers and public service commission or other permit or license number of any infectious medical waste transporter, if applicable;
5.2.h. Training procedures, including an outline of training programs, and procedures for the certification of personnel involved in the treatment of infectious medical waste;
5.2.i. The name, mailing and email addresses, and telephone numbers of the person responsible for infectious medical waste management at the generator or the facility, and the name, mailing and email addresses, and telephone numbers of an alternate person to contact in the event the manager is not available;
5.2.j. Policies requiring that no infectious medical waste will be knowingly transported or knowingly received by the generator or facility without being packaged and labeled in accordance with this rule;
5.2.k. Contingency plans for effective action to minimize damage from any interruption in treatment, storage or disposal of infectious medical waste;
5.2.1. A description of the procedures used to:
5.2.1.1. Prevent hazards in loading and unloading operations;
5.2.1.2. Prevent run-off from infectious medical waste handling areas to other areas of the facility or environment;
5.2.1.3. Prevent contamination of water supplies;
5.2.1.4. Mitigate effects of equipment failure and power outages;
5.2.1.5. Prevent exposure of personnel to infectious medical waste; and
5.2.1.6. Address spill prevention and spill mitigation procedures;
5.2.1.6.a Include procedure for use of personal protective equipment(PPE); and
5.2.1.6.b. Include contents of the required spill kit, set forth in section 7 of this rule.
5.2.m. Procedures for continuity of operations during a change of ownership;
5.2.n. Any other information pertinent to the evaluation of compliance with this rule.
5.3. Infectious medical waste management facilities which are willing to accept infectious medical waste generated off-site for treatment shall also include the following in their infectious medical waste management plan:
5.3.a. Procedures for receiving off-site infectious medical waste which are consistent with this rule;
5.3.b. A statement as to whether the facility plans to receive from off-site more than thirtyfive (35) percent by weight of the total amount of infectious medical waste at the facility;
5.3.c. A statement that the facility will not knowingly accept any infectious medical waste which is not properly packaged and labeled in accordance with Section 6 of this rule;
5.3.d. Procedures for keeping records in accordance with Section 13 of this rule;
5.3.e. Procedures for returning manifests or other shipping documents to the generator after treatment of the infectious medical waste;
5.3.f. Procedures for reporting to the Secretary as required by this rule; and
5.3.g. Procedures to be followed for closure of the facility including, but not limited to, notification of all facilities using the treatment service thirty (30) days prior to closure.
5.4.The infectious medical waste management plan shall comply with this rule.
5.5. Infectious medical waste management facilities shall operate in compliance with their infectious medical waste management plan as approved by the Secretary.
5.6. Disposal of untreated infectious medical waste in this State is prohibited.
W. Va. Code R. § 64-56-6 Packaging and Labeling
6.1. General.
6.1.a. The generator of infectious medical waste shall be responsible for ensuring that the packaging and labeling of infectious medical waste is in compliance with this rule and any other applicable state or federal laws or regulations.
6.1.b. Contractors or other agents may provide services to the generator, including packaging and labeling of infectious medical waste: Provided, however, that no contract or other relationship shall relieve the generator of the responsibility for packaging and labeling the infectious medical waste as required by this rule. Nothing in this section shall be construed to prevent or limit any cause of action by a generator against any other party for any reasons for which the law gives a remedy.
6.1.c. No person shall knowingly accept for transportation, storage, treatment or disposal any infectious medical waste that is not packaged and labeled in accordance with this rule. Contractors or other agents may package or repackage infectious medical waste to comply with this rule, if the packaging or repackaging is performed prior to transportation off-site or storage on-site. Proper repackaging of infectious medical waste that has spilled during transportation is required prior to further transportation.
6.2. Packaging.
6.2.a. All infectious medical waste shall be packaged as required by this rule prior to storage, treatment, or transport.
6.2.b. Infectious medical waste shall be contained and sealed on-site in leak-proof plastic bags as required by 49CFR173.197. Free liquids shall be contained in break-resistant, tightly stoppered containers. Heavier materials shall be supported in double-walled corrugated fiberboard boxes or equivalent rigid containers.
6.2.c. Sharps shall be collected at the point of generation in rigid, leak-proof and puncture-resistant containers clearly marked as infectious medical waste. Containers shall be compatible with selected treatment processes to preclude contact with waste materials, and sealed before handling. Sharps containers shall not be completely filled.
6.2.c.1. If the sharps are to be stored or treated off-site, the containers shall be placed inside a plastic bag as specified in Section 6.2.b of this rule. Prior to storage, the plastic bags shall be bound at the gathered open end with tape or another closing device that prevents leakage of liquids. Transporters utilizing properly constructed transport carts for large sharps containers which secure the containers are exempt from this requirement.
6.2.c.2. Sharps which are rendered noninfectious and encapsulated in a solid state on-site may be discarded as solid waste. The encapsulated container shall be labeled in accordance with Section 6.3.b of this rule.
6.2.d. Bags containing infectious medical waste at facilities where on-site treatment will occur shall be red in color except that infectious medical waste that is to be steam treated shall be contained in orange bags and marked with autoclave tape or other heat-activated ink which will indicate whether or not the appropriate temperature, as required by this rule, has been reached. Both red and orange bags shall be imprinted with the international biohazard symbol and the words "infectious medical waste" or "biomedical waste" or "biohazard" or "regulated medical waste".
Waste contained in red bags shall be considered infectious medical waste and managed as infectious medical waste. Waste contained in orange bags shall be managed as infectious medical waste prior to steam treatment and as solid waste after steam treatment. This waste shall not be removed from the orange bags and shall not be enclosed in bags of different colors.
6.2.e. Bags containing infectious medical waste which is to be transported off-site for treatment shall be red in color and shall be imprinted with the international biohazard symbol and the words "infectious medical waste" or "biomedical waste" or "biohazard" or "regulated medical waste.
Waste contained in red bags shall be considered infectious medical waste and managed as infectious medical waste. In addition to other packaging, all infectious medical waste which is to be transported off-site shall also be packaged in double-wall corrugated fiberboard boxes or equivalent rigid containers. The boxes or containers shall be leak-resistant and lined with a tear-resistant leak-proof plastic bag.
6.2.f. Reusable containers shall be leak-proof and, shall have tight-fitting covers, and shall be kept clean and in good repair. Reusable containers shall be thoroughly washed and disinfected.
Disposable liners, bags or other devices shall be removed and handled as infectious medical waste.
Red bags may not be enclosed in bags of different colors.
6.2.g. Disinfection of the container shall be accomplished by one of the following methods:
6.2.g.1. Immersion in hot water at a temperature of at least one hundred and eighty degrees Fahrenheit(180 ºF) for a minimum of thirty (30) seconds;
6.2.g.2. Exposure to a chemical sanitizer by immersion in one of the following for a minimum of thirty (30) seconds: hypochlorite solution of one hundred parts per million (100 ppm) available chlorine; iodoform solution of twenty-five parts per million (25 ppm) available iodine; or quaternary ammonium solution of two hundred parts per million (200 ppm) active agent per manufacturer's instructions; or
6.2.g.3. Swabbing or rinsing the container with a chemical sanitizer double the strength specified in Section 6.2.g.2 of this rule or a chemical with equivalent sanitizing capabilities.
6.2.h. Employers shall direct employees packaging infectious medical waste to use personnel protection equipment and shall provide training in its use.
6.3. Labeling Requirements.
6.3.a. Infectious medical waste to be transported off-site shall be labeled prior to being stored on-site or transported off-site. The label shall be securely attached to the outer layer of packaging and shall be clearly legible. Permanent ink shall be used to complete the information on the label and, if handwritten, the label shall be at least three (3) inches by five (5) inches in size. The following information shall be included on the label:
6.3.a.1. The name, address, business telephone numbers of the generator;
6.3.a.2. The name, address, business telephone numbers of all transporters; and
6.3.a.3. The date on which the infectious medical waste was packaged.
6.3.b. Recognizable treated noninfectious medical waste shall be labeled prior to being transported off-site. Treated medical waste that will pass through a screen with a one-half inch (1/2) grid shall be considered not recognizable. The label shall meet the requirements in Section 6.3.a of this rule for infectious medical waste. The following information shall be included on the label:
6.3.b.1. The name, address and business telephone numbers of the generator;
6.3.b.2. The name, address, and business telephone numbers of the facility at which the waste was rendered noninfectious;
6.3.b.3. The weight of the treated noninfectious medical waste and the method of treatment; and
6.3.b.4. A signed and dated certification by the facility where the waste was rendered noninfectious which states: "I hereby certify under penalty of law that this waste has been rendered noninfectious in accordance with procedures required by Infectious Medical Waste Rule, 64CSR56."
6.4. Facilities that render infectious medical waste non-infectious within their facility, may manifest the entire load of treated waste in lieu of individual bag labeling. The facility shall apply to the Secretary for a waiver with rationale supporting the request. Once approved, the changes and procedures shall be reflected in the Infectious Medical Waste Management Plan.
Commercial treatment facilities are exempt from this requirement. Facilities currently in operation at the effective date of this rule that render infectious medical waste non-infectious within their facility are not required to apply for a waiver.
W. Va. Code R. § 64-56-7 Management of Spills of Infectious Medical Waste
7.1. All infectious medical waste management facilities shall provide a spill kit for management of spills of infectious medical waste.
7.2. Large Quantity Generators of infectious medical waste shall keep a spill containment and cleanup kit within the vicinity of any area where infectious medical waste is managed on a bulk storage basis. The location of the kit shall provide for rapid and efficient cleanup of spills anywhere within the area.
7.2.a. The kit shall contain an amount of absorbent material sufficient to have a rated capacity of one (1) gallon of liquid for every cubic foot of infectious medical waste that is normally managed in the area for which the kit is provided or of ten (10) gallons, whichever is less.
7.2.b. The kit shall contain one (1) gallon of hospital grade disinfectant in and a sprayer capable of dispersing its charge in a mist or in a stream at a distance. The disinfectant shall be hospital-grade and effective against mycobacteria.
7.2.c. The kit shall contain enough red plastic bags to enclose one hundred and fifty percent (150%) of the maximum quantity stored. The bags shall meet the requirements in 6.2 of this rule and shall be accompanied by sealing tape or devices and labels or tags. These bags shall be large enough to enclose any box or other container normally used for infectious medical waste management by that facility.
7.2.d. The kit shall contain two (2) new sets of overalls, gloves, boots, caps, and devices to protect the eyes and respiratory tract, and tape for sealing wrists and ankles. The overalls, boots and caps shall be oversized or fitted to the infectious medical waste workers or transporters, and shall be made of materials impermeable to liquids. Boots may be of thick rubber and gloves shall be of heavy neoprene or equivalent material. Boots, gloves and breathing devices may be reused if disinfected between uses.
7.2.e. The kit shall contain an adequate first aid kit and an adequate amount of boundary marking tape.
7.3 Small Quantity Generators of infectious medical waste shall keep a spill containment and cleanup kit within the vicinity of any area where infectious medical waste is managed . The location of the kit shall provide for rapid and efficient cleanup of spills anywhere within the area.
7.3.a. The kit shall contain, at a minimum the following:
7.3.a.1. Two (2) red plastic bags that meet the requirements in 6.2 of this rule;
7.3.a.2. One (1) pair of gloves impervious to moisture;
7.3.a.3. One (1) face mask (surgical type or equivalent);
7.3.a.4. One (1) pair of goggles or equivalent eye protection;
7.3.a.5. Absorbent material capable of absorbing one-half (1/2) gallon of liquid;
7.3.a.6. Spray can of disinfectant effective against tuberculosis/mycobacterium; and
7.3.a.7. A disposable dust pan and broom for sweeping up sharps.
7.3.b. The above items shall be stored in a heavy container with a tight fitting lid, appropriately labeled, and which can be used to contain wastes generated after a clean-up.
7.4. All vehicles transporting infectious medical waste shall carry a spill containment kit in the vehicle whenever infectious medical waste is conveyed. The kit shall contain at a minimum the following:
7.4.a. An adequate amount of absorbent material;
7.4.b. One (1) gallon of hospital grade disinfectant in a sprayer capable of dispersing its charge in a mist or in a stream at a distance. The disinfectant shall be hospital-grade and effective against mycobacteria;
7.4.c. Fifty (50) red plastic bags that meet the requirements in 6.2. of this rule. The bags shall be accompanied by seals and appropriate labels, and shall be large enough to over-pack any container normally transported in the vehicle;
7.4.d. Two (2) new sets of overalls, gloves, boots, caps, face mask, goggles or equivalent eye protection and tape for sealing wrists and ankles. The overalls, boots and caps shall be oversized or fitted to the infectious medical waste workers or transporters, and shall be made of materials impermeable to liquids. Boots may be of thick rubber and gloves shall be of heavy neoprene or equivalent material. Boots, gloves and breathing devices may be reused if disinfected between uses; and
7.4.e. A first aid kit, boundary marking tape and other appropriate safety equipment.
7.5. Immediately following a spill of infectious medical waste or its discovery, all individuals present shall leave the area until any aerosol settles.
7.6. The following procedures for cleaning up a spill shall be implemented:
7.6.a. Put on cleanup outfits as described in Section 7.1.4 of this rule and secure the spill area from entry by unauthorized persons;
7.6.b. Spray all broken containers of infectious medical waste with disinfectant; 7.6c. Place broken containers and spillage into red bags;
7.6.d. Disinfect and take other steps necessary to clean up the area;
7.6.e. Clean and disinfect non-disposable items and clothing;
7.6.f. Remove cleanup outfits and place disposable items in a red bag; and
7.6.g. Take prompt steps to initiate procedures for the replenishment of the containment and cleanup kit.
7.7. When a spill involves a single container of infectious medical waste with a weight of less than fifty (50) lbs. and a volume of spilled liquid of less than one (1) quart, the individual responsible for the cleanup may elect to use dress and procedures other than those required by Section 7.1.d of this rule. Any proposed alternate procedures for small quantity spills shall be specified in the infectious medical waste management plan and shall provide protection to the health of workers and the public equivalent to that provided by the procedures specified in Section 7.2 of this rule.
W. Va. Code R. § 64-56-8 Storage of Infectious Medical Waste
8.1. This section is applicable to the storage of infectious medical waste at any time after packaging (sealing) for transport, including time spent during transportation and at all treatment and disposal sites or facilities.
8.2. Infectious medical waste other than sharps shall not be stored for more than thirty (30) days prior to transportation to an infectious medical waste management facility, even if refrigerated:
Provided, that the total amount of storage time, including transportation to an infectious medical waste management facility, shall not exceed forty-five (45) days. Facilities that treat infectious medical waste on-site shall not store the infectious medical waste more than thirty (30) days.
8.3. Infectious medical waste shall be stored in a specifically designated area located at or near the treatment site, or at the pickup point if it is to be transported off-site for treatment.
8.4. The manner of storage shall maintain the integrity of the containers; prevent the leakage of waste from the container; provide protection from water, rain and wind, and maintain the waste in a non-putrescent state.
8.5. All storage areas shall be constructed of materials which are durable, easily cleanable, impermeable to liquids, and affords protection from animals and does not provide a breeding place or a food source for insects or rodents.
8.6. Carpets and floor coverings with open seams in which water may be entrapped shall not be used in storage areas. All floor drains shall discharge directly to a sanitary sewage disposal system which is in compliance with Sewage System Rules, 64CSR9 or other containment system which prevents any spilled materials from reaching the environment.
8.7. All storage areas shall be kept clean and in good repair.
8.8. All storage areas shall have access control that limits access to those persons specifically designated to manage infectious medical waste. The areas shall be posted prominently with the international biohazard symbol and with warning signs located adjacent to the exterior of entry doors, gates or lids which indicate the use of the area for storage of infectious medical waste and that entry to unauthorized persons is denied.
8.9. Infectious medical waste shall not be placed in chutes at any time.
8.10. Compaction of infectious medical waste or subjecting infectious medical waste to mechanical action is prohibited unless as a part of a specific treatment process approved by the Secretary.
W. Va. Code R. § 64-56-9 Transportation
9.1. This section applies to all transportation of infectious medical waste over roads or highways within West Virginia, regardless of point of origin or intended disposal, except as specified in Sections 9.2 and 9.3 of this rule.
9.2. A small quantity generator may transport his or her infectious medical waste to a permitted infectious medical waste management facility, or may arrange for transport by his or her employee as follows:
9.2.a. An employee who transports the infectious medical waste shall be trained in the proper handling of infectious medical waste as required by this rule; and
9.2.b. The infectious medical waste shall be delivered within forty-five (45) days of its generation, or
9.2.c. Via the U.S. postal service or other commercial delivery services, if the requirements set by that agency are met.
9.3. A generator that transfers infectious medical waste on- site shall be exempt from Sections 9.9, 9.10, 9.11 and 9.12 of this rule: Provided, that:
9.3.a. On-site transfer of infectious medical waste is covered in the infectious medical waste management plan; and
9.3.b. No off-site infectious medical waste is knowingly and routinely accepted for on-site transfer.
9.4. No person shall knowingly receive for transportation any infectious medical waste that is not packaged and labeled in accordance with Section 6 of this rule.
9.5. A transporter shall deliver infectious medical waste in West Virginia only to a permitted infectious medical waste management facility. Transporters of infectious medical waste out of state shall transport it to a facility permitted by the receiving jurisdiction.
9.6. All vehicles transporting infectious medical waste shall be prominently identified while transporting the infectious medical waste with the following, except for vehicles used as specified in Sections 9.2 and 9.3 of this rule:
9.6.a. The international biohazard symbol;
9.6.b. The words "infectious medical waste", or "biomedical waste", or "biohazard" or "regulated medical waste";
9.6.c. The number of the transporter's permit issued by the Secretary; and
9.6.d. If applicable, a placard in accordance with United States Department of Transportation requirements. Removable signs are acceptable.
9.7. Vehicles that transport infectious medical waste:
9.7.a. Shall include a cargo-carrying portion that shall be closed and secured except when loading or unloading infectious medical waste to prevent unauthorized access and exposure to wind and precipitation;
9.7.b. Shall be designed and constructed so as to minimize any spillage;
9.7.c. Shall be cleaned and disinfected following leakage or spills as provided in Section
6.2.g.3 of this rule;
9.7.d. Shall be cleaned and disinfected prior to using the conveyance for any other purpose as provided in Section 6.2.g.3 of this rule; and
9.7.e. Shall not be used to transport food, foodstuffs, food additives, food containers or any substances to be ingested by people or animals or applied to food or feed simultaneously with the transport of infectious medical waste.
9.7.f. Separate, removable cargo-carrying containers are acceptable and if used, Sections
9.7.a through 9.7.e of this rule shall apply to the containers in lieu of the entire vehicle.
9.8. All vehicles transporting infectious medical waste shall carry a spill containment and cleanup kit as required by Section 7 of this rule in the vehicle whenever infectious medical waste is conveyed. Spills of infectious medical waste during transportation shall be managed as required by Sections 7.5 and 7.6 of this rule. Any spill of fifty (50) pounds or more shall be reported as soon as possible to the employer and the Secretary. Direct physical contact of the transport vehicle or equipment with infectious medical waste shall be considered and managed as a spill.
9.9. No person shall transport infectious medical waste in West Virginia for another who does not possess a permit issued by the Secretary, and, if applicable, valid authority issued by the public service commission. Permits issued by the Secretary shall not be transferable or assignable and shall automatically become invalid upon a change of ownership or upon suspension or revocation.
9.10. An application for a permit to transport infectious medical waste shall be made in writing to the Secretary on a form prescribed by the Secretary. The application form shall be signed by the applicant or his or her authorized representative. The application shall contain at a minimum the following:
9.10.a. The applicant's name;
9.10.b. The business and email addresses and telephone numbers of the applicant, including both headquarters and local office;
9.10.c. The number of vehicles being permitted to transport infectious medical waste within West Virginia;
9.10.d A description of the vehicles being permitted;
9.10.e. The name of any person or firm other than reported in Section 9.10. of this rule that is associated with the applicant or any other name under which that person or firm does business;
9.10.f. The name of any other person or firm using any of the same vehicles and operators;
9.10.g. The name and telephone numbers of a person who may be contacted in the event of an accident or spill;
9.10.h. Verification that the applicant has established a program of and is providing training for employees involved in the transportation of infectious medical waste as required by this rule; and
9.10.i. Designation of the treatment facilities to be used.
9.11. The application shall be accompanied by a fee per transport vehicle according to the fee schedule shown in Table 64-56A found at the end of this rule. An application for renewal shall be submitted with the fee thirty (30) days prior to the expiration date of an existing permit.
9.12. Once the application has been approved by the Secretary, and upon verification that the applicant has been duly authorized by the public service commission, if applicable, a permit for the number of vehicles on the application shall be issued to the applicant. All transport vehicles shall display the decal provided by the public service commission as required by the commission. The original permit issued by the Secretary shall be kept in the transport vehicle at all times.
9.13. Permits for transport vehicles issued after the effective date of this rule will expire at midnight on the 31st day of December following the date of issuance.
9.14. Upon request, the transporter shall provide the Secretary with information needed for the investigation of the handling of particular infectious medical waste including, but not limited to, the names, addresses and telephone numbers of transporters from or to whom the transporter has received or transferred infectious medical waste and infectious medical waste management facilities and generators with which the transporter has a contract or agreement for services.
9.15. All infectious medical waste transport vehicles shall be subject to inspection by the Secretary without prior notice to evaluate compliance with this rule.
W. Va. Code R. § 64-56-10 Methods of Treatment
10.1. General.
10.1.a. All infectious medical waste shall be treated by one of the following methods:
10.1.a.1. Incineration as described in Section 10.2 of this rule;
10.1.a.2. Steam treatment as described in Section 10.3 of this rule;
10.1.a.3. Discharge to a sanitary sewer as described in Section 10.4 of this rule; or
10.1.a.4. Any other alternative method approved in writing and permitted by the Secretary according to the provisions of Section 10.5 of this rule.
10.1.b. The residue or ash remaining after the treatment of infectious medical waste in accordance with this rule becomes noninfectious medical waste and may be disposed of in the same manner as ash from solid waste incineration and as provided in subdivision 10.2.e. of this rule.
10.2. Incineration.
10.2.a. All owners and operators of infectious medical waste incinerators are required to comply with applicable State laws and with rules of the West Virginia Department of Environmental Protection's Division of Air Quality.
10.2.b. Whenever infectious medical waste is introduced into an incinerator, all the waste shall be subjected to a burn temperature of not less than one thousand four hundred degrees Fahrenheit (1400 °F) for a period not less than one (1) hour. Gases generated by the combustion shall be subjected to a temperature of not less than one thousand eight hundred degrees Fahrenheit (1800 °F) for a period of one (1) second or more.
10.2.c. An incinerator used for treatment of infectious medical waste shall have interlocks or other process control devices to prevent feeding of the incinerator until the conditions specified in
Section 10.2.b of this rule can be achieved. In the event low temperatures occur, facilities shall have automatic auxiliary burners which are capable, excluding the heat content of the waste, of independently maintaining the secondary chamber temperature at the minimum of one thousand eight hundred degrees Fahrenheit (1800 ºF).
10.2.d. There shall be continuous monitoring and recording of primary and secondary chamber temperatures. Monitoring data shall be maintained for a period of three (3) years.
10.2.e. All combustible waste shall be converted by the incineration process into ash that is not recognizably in its pre-incineration form. Incinerator ash shall be tested at least quarterly, using a commingled random sample, for total organic carbon content, and annually for lead, mercury, cadmium, and other heavy metals. A maximum of five percent (5%) fixed carbon shall be permitted (minimum ninety-five percent (95%) burnout).
10.2.f. All individuals who operate infectious medical waste incinerators shall be registered with the Secretary. The Secretary shall issue a registration number to individuals who complete a course of study approved by the Secretary; obtain a passing score on a written examination; and pay the fee shown in Table 64-56A found at the end of this rule.
10.3. Steam Treatment.
10.3.a. A steam treatment process for infectious medical waste shall at all times maintain:
10.3.a.1. A temperature of not less than two hundred and fifty degrees Fahrenheit (250 "F) for ninety (90) minutes at fifteen (15) pounds per square inch of gauge pressure; or
10.3.a.2. A temperature of two hundred and seventy-two degrees Fahrenheit (272 ºF) for forty-five (45) minutes at twenty-seven (27) pounds per square inch; or
10.3.a.3. A temperature of two hundred and fifty degrees Fahrenheit (250 °F) for twentyeight (28) minutes at eighty (80) pounds per square inch; or
10.3.a.4. A temperature of two hundred and seventy degrees Fahrenheit (270 °F) for sixteen (16) minutes at eighty (80) pounds per square inch; or
10.3.a.5. A temperature of two hundred and seventy degrees Fahrenheit (270 ºF) for thirty (30) minutes at thirty-two (32) pounds per square inch; or
10.3.a.6. Other combinations of operational temperatures, pressure and time approved by the Secretary. Other combinations may be approved if the installed equipment has been proved to achieve a reliable kill of all infectious microorganisms in infectious medical waste at design capacity.
Complete and thorough testing of such other combinations of temperature and pressure shall be fully documented, including tests of the capacity to kill Bacillus stearothermophilus. Longer steam treatment times are required when a load contains a large quantity of liquid.
10.3.b. Each package of infectious medical waste to be treated on-site with steam shall have a tape attached that will indicate if the steam treatment temperature has been reached. The infectious medical waste shall not be considered satisfactorily treated if the indicator does not indicate that the treatment temperature was reached during the process. Each package shall also be labeled according to the requirements of Section 6.3.b or comply with Section 6.4 of this rule after treatment if recognizable.
10.3.c. Steam treatment units shall be evaluated under full loading for effectiveness with spores of Bacillus stearothermophilus no less than once per every forty (40) hours of operation.
10.3.d. A log shall be kept at each steam treatment unit that is complete for the preceding three (3) year period. The log shall record:
10.3.d.1. The date, time and operator of each usage;
10.3.d.2. The type and approximate amount of waste treated;
10.3.d.3. The post-treatment reading of the temperature sensitive tape (on-site treatment only);
10.3.d.4. The dates and results of calibration; and
10.3.d.5. The results of the testing required by Section 10.3.c of this rule.
10.3.e. Where multiple steam treatment units are used, a working log can be maintained at each unit and such logs periodically consolidated at a central location. The consolidated logs shall be retained for three (3) years and be available for review.
10.4. Sanitary Sewer.
Liquid infectious medical waste may be discharged to a sanitary sewer through a drainage fixture of a size and type adequate to discharge the waste in a sanitary manner to a sewer system approved by the Secretary according to Sewage System Rules, 64CSR9. The use of a grinder to reduce infectious solid matter to a size or consistency which can be discharged to a sewer is prohibited.
10.5. Alternative Methods.
10.5.a. The Secretary may approve an alternative method of treatment not described in this
rule if the Secretary determines that the proposed process will render infectious medical waste noninfectious and will provide protection to the health and safety of the public and workers at least the equivalent to the methods found at Sections 10.2, 10.3 or 10.4 of this rule.
10.5.b. The Secretary may issue provisional approval to any alternate method until an appropriate trial period can validate performance. Alternate methods employing disinfection must have the disinfectant registered for that purpose in accordance with the federal Insecticide, Fungicide, and Rodenticide Act as amended. If the process fails to provide adequate treatment when operated according to manufacturer's instructions, the provisional approval shall be revoked.
10.5.c. In addition to complying with other sections of this rule, an application for approval of an alternate method shall include:
10.5.c.1. A listing of the classes and amounts of infectious medical waste the method could be employed to treat;
10.5.c.2. A copy of the detailed plans for the device used in the method;
10.5.c.3. A written summary of the proper operation of the method and device;
10.5.c.4. A copy of the operation and maintenance manual for the process or device;
10.5.c.5. Copies of approval and denial letters from other states where the process has been evaluated; and
10.5.c.6. A copy of an evaluation report provided by a testing laboratory independent of the applicant using a testing protocol approved by the Secretary confirming the efficacy of the treatment process and that the process does not produce a hazardous waste, discharge or air emission.
10.5.d. To evaluate alternative treatment technologies, the Secretary shall use the procedures outlined in the following referenced manual that is incorporated in this rule: State and Territorial Association on Alternate Treatment Technologies, Technical Assistance Manual: State Regulatory Oversight of Medical Waste Treatment Technologies.
10.5.e. A non-refundable alternative technology evaluation fee shall be submitted with the application in accordance with Table 64-56A at the end of this rule.
W. Va. Code R. § 64-56-11 Commercial Infectious Medical Waste Management Facilities
11.1. This section of this rule applies only to commercial infectious medical waste management facilities.
11.2. A commercial infectious medical waste management facility may not utilize incineration technology in any form, including the manufacture or burning of refuse-derived fuel in any form.
11.3. A commercial infectious medical waste management facility shall have effective controls for the management of infectious medical waste to ensure the protection of public health, safety, welfare and the environment.
11.4. The Secretary shall conduct an investigation of the infectious medical waste stream in the region affected by the proposed facility and determine that programs have been established to minimize and reduce the infectious medical waste stream the facility will serve prior to issuing a permit. The Secretary may issue a permit only if he or she makes a specific finding that as to the medical waste stream the proposed facility will be consistent with the legislative findings and
purpose stated in W. Va. Code § 20-5J-2.
11.5. No person may establish, construct, operate, maintain, or allow the use of property for a commercial infectious medical waste management facility within:
11.5.a. The one-hundred (100) year flood plain;
11.5.b. Five hundred (500) feet of a dwelling, measured from the edge of the boundary of the facility, unless written permission is received from the owner of the dwelling;
11.5.c. An area where the Secretary has determined, after consultation with relevant state and federal agencies, that the facility will be in violation of applicable state or federal laws or regulations concerning:
11.5.c.1. Wetlands;
11.5.c.2. Any endangered or threatened species of animal or plant;
11.5.c.3. Surface water;
11.5.c.4. Groundwater quality; or
11.5.c.5. The emission of any air contaminant.
11.6. A proposed infectious medical waste management facility shall provide evidence of financial capability suitable to the scope of the facility to the Secretary.
11.6.a. Prior to the issuance of a permit to operate a commercial infectious medical waste treatment facility, the intended operator shall obtain a performance bond payable to the Secretary in an amount established by the Secretary equal to the projected cost of operating the facility for sixty (60) days at full capacity.
11.6.a.1. The performance bond shall be paid to the Secretary upon:
11.6.a.1.a. Closure of the facility, including voluntary closure and closure as a result of permit revocation or suspension, unless thirty (30) days before closure the operator has notified the Secretary of closure and before closure has provided the Secretary with certified mail receipts of its mailing of notices of closure to all its customers thirty (30) days before closure: Provided, That a performance bond payment made under this subparagraph shall be returned by the Secretary upon verification that the operator provided the notices as required; or
11.6.a.1.b. Improper closure of the facility requiring corrective expenditures by the Secretary.
11.6.a.2. A bond payment may be used by the Secretary to correct an improper closure and to continue operation of a facility until its customers can be properly notified of the pending closure.
11.7. No person may own, construct, modify or operate a commercial infectious medical waste facility, nor may any person store, transport, treat or dispose of any infectious medical waste without first obtaining a permit from the Secretary.
11.8. The owner of an infectious medical waste facility is responsible for insuring that the facility has a permit.
11.9. Pre-siting Notices.
11.9.a. In order to obtain approval to locate a commercial infectious medical waste facility, an applicant shall, in accordance with W. Va. Code § 20-5K-3, Procedure for Public Participation, file a pre-siting notice with the Secretary, the department of environmental protection and the county commission or commissions and the local solid waste authority or authorities of the county or counties in which the facility is to be located. Such notice shall be available for public review, and shall include:
11.9.a.1. A description of the location at which the proposed facility may be sited;
11.9.a.2. Information concerning the anticipated size of the proposed facility;
11.9.a.3. An estimate of the volume, type, and origin of the infectious medical waste to be handled at the proposed facility;
11.9.a.4. A United States Geological Survey (USGS) topographic map showing the location and anticipated boundaries of each site being considered for the proposed facility;
11.9.a.5. A description of the technology that is to be used in the treatment of infectious medical waste;
11.9.a.6. The name, address, telephone numbers and e-mail-address of the owner or applicant of the proposed facility;
11.9.a.7. The name, address, telephone numbers and e-mail address of the operator of the proposed facility, if different from the owner or applicant; and
11.9.a.8. Other information that the Secretary may require.
11.10. Permit Application Requirements. An application for a permit shall be submitted to the Secretary on forms prescribed by the Secretary, and unless otherwise specified in this rule, shall include the following:
11.10.a. The name, mailing address, and location of the facility for which the application is submitted;
11.10.b. The name, address, telephone number and e-mail address of the owner of the facility, and if the owner is an individual or a partnership;
11.10.c. The name, address, telephone number and e-mail address of the manager of the facility, if different from the owner; and if the manager is an individual or partnership different from the owner;
11.10.d. A proposed infectious medical waste management plan as required by Section 5 of this rule. The infectious medical waste management plan shall be incorporated into the permit as
part of the permit conditions;
11.10.e. A description of the legal documents upon which the applicant bases his or her legal right to enter and conduct operations on the facility permit area and whether that right is the subject of pending court litigation;
11.10.f. All application documents related to engineering and design plans and specifications as compiled, signed, and sealed by a professional engineer who is registered to practice in West Virginia;
11.10.g. Appropriate legible exhibits, including maps, figures, photographs, and tables, of appropriate scale to show all required details necessary to clarify information or conclusions;
11.10.h. Documentation of arrangements for permitted facilities to receive all treated waste and wastewater;
11.10.i. A treatment technology plan in accordance with the provisions of Section 10.3 through 10.5 of this rule;
11.10.j. Financial assurance in the form of a collateral bond, an escrow account or a letter of credit equal to the proposed cost of the project;
11.10.k. A proposed design and a general discussion of the proposed operating procedures;
11.10.1. A notarized signature of the owner or principal officer verifying that the information contained in the application is true and correct to the best of that individual's knowledge and belief;
11.10.m. A review of land use zoning in the area with particular attention given to areas where zoning variances will be required, where agricultural impact statements may be required, or where flood plain, river corridors, or wetlands are designated;
11.10.n. A description of the present land use within two (2) miles of the permit area. The description shall include, but not be limited to:
11.10.n.1. Impacts upon transportation facilities;
11.10.n.2. Impacts upon public and private water supplies;
11.10.n.3. Impact upon land use patterns;
11.10.n.4. Impacts upon agricultural, commercial and residential real estate values;
11.10.n.5. Impacts upon wildlife;
11.10.n.6. Impacts upon endangered or threatened species of animals or plants;
11.10.n.7. Impacts upon aesthetics;
11.10.n.8. Impacts upon socioeconomic conditions;
11.10.n.9. Impacts to water resources;
11.10.n.10. Impacts on sewage collection and treatment systems;
11.10.n.11. Impacts on local emergency response crews and firefighters;
11.10.n.12. Impacts upon known recreational, historical, archaeological, or environmentally unique areas; and
11.10.n.13. Other impacts as determined by the Secretary;
11.10.o. A large-scale map with a minimum scale of one (1) inch equal to two hundred (200) feet and a maximum contour interval of ten (10) feet, or a 7.5 minute topographic map, showing the location of all of the following that occur either within the site boundaries or within two thousand five hundred (2,500) feet of the site:
11.10.0.1. Water supply wells;
11.10.0.2. Springs;
11.10.0.3. Wetlands (e.g., swamps, bogs, marshes);
11.10.0.4. Streams and drainages;
11.10.0.5. Public water supplies;
11.10.0.6. Other bodies of water;
11.10.0.7. Underground or surface mines;
11.10.0.8. Water quality monitoring points;
11.10.0.9. Occupied dwellings;
11.10.0.10. Roads;
11.10.0.11. Public buildings;
11.10.0.12. Sinkholes;
11.10.0.13. Property boundaries, including site property;
11.10.0.14. Current owners of record both surface and subsurface;
11.10.0.15. Easements or rights-of-way; and
11.10.0.16. One hundred (100) year flood plain boundary;
11.10.p. A description of present and proposed transportation routes and access roads, including any weight restrictions;
11.10.q. A description of buildings, treatment units, roads, and other structures to be constructed in conjunction with the facility, including the size of the construction and the number of miles of road to be constructed;
11.10.r. A description of emissions and discharges, such as dust, odors, gases, leachate, surface water runoff and collected groundwater associated with facility preparation, construction, operation and during and after closure of the facility;
11.10.s. A copy of any building permits required; and
11.10.t. A non-refundable application fee according to the schedule shown in Table 64-56A at the end of this rule.
11.11. Modifications.
11.11.a. When a permit is modified, only the conditions subject to modification are reopened. All other conditions of the permit remain in effect for the duration of the permit.
11.11.b. The Secretary may require additional information and, in the case of a major modification, may require submission of a new permit application.
11.11.c. Minor Modifications.
11.11.c.1. Modifications, except for major modifications as listed in this section, in the infectious medical waste plan may be made without notifying the Secretary and shall be included in the next application for permit renewal.
11.11.c.2. Permits may be modified by the Secretary at any time except for major modifications as listed in this section. Minor modifications do not require the completion of the public notice procedures.
11.11.d. Major Modifications.
A permittee shall submit an application for approval of a major modification before implementing the change. All major modifications shall be approved prior to implementation and require the opportunity for a public hearing as required by this rule unless an emergency is declared by the Secretary. For the purpose of this section a major modification means:
11.11.d.1. The capacity of the commercial infectious medical waste facility will be increased over the permitted capacity by more than ten percent (10%);
11.11.d.2. The performance or operation of the surface water control system will be significantly affected;
11.11.d.3. A decrease in the quality or quantity of data from any environmental monitoring system will occur;
11.11.d.4. The amount or type of financial assurance will change;
11.11.d.5. The facility boundary will be significantly changed;
11.11.d.6. Authorization is being sought to construct an additional structure used to increase the capacity of the facility;
11.11.d.7. Different permitted facilities are being considered to receive treated waste or wastewater;
11.11.d.8. Installing a new unit for the treatment of infectious medical waste or replacing existing treatment units not to include repair or improvements to existing units;
11.11.d.9. Changing the location of treatment;
11.11.d.10. Any other action that the Secretary determines may present substantial endangerment to public health, safety or the environment; or
11.11.d.11. Other similar modifications as determined by the Secretary.
11.11.e. Major modifications to an initial application for a new commercial infectious medical waste facility require the applicant to undergo a new pre-siting process as described in Sections 11.9. through 11.12 of this rule.
11.11.f. Permit renewals that contain major modifications shall be treated as major modifications.
11.12. Permit Suspension or Revocation.
11.12.a. Suspension. A commercial infectious medical waste facility permit may be suspended by order of the Secretary for any of the following reasons:
11.12.a.1. Violation of or failure to adhere to, W. Va. Code § 20-5J-1 et seq., this rule, the terms and conditions of the permit, or any order of the Secretary issued thereunder;
11.12.a.2. Interference with a representative of the Secretary in the performance of his or her duties; or
11.12.a.3. Discovery of failure in the application or during the permit issuance process to fully disclose all significant facts or the permittee's misrepresentation of any significant fact at any time.
11.12.b. Revocation. A commercial infectious medical waste facility permit may be revoked by order of the Secretary for any of the following reasons:
11.12.b.1. An attempt by an applicant or permittee to obtain or renew a permit by means of fraud, deceit or material misrepresentation;
11.12.b.2. Any deficiency at the facility constituting an imminent pollution, health, or safety hazard;
11.12.b.3. Persistent violation of W.Va. Code § 20-5J-1 et seq., this rule, permit terms and conditions, or orders issued by the Secretary under that Code Article or this rule;
11.12.b.4. Discovery of failure in the application, or during the permit issuance process, to fully disclose all significant facts or the permittee's misrepresentation of any significant fact at any time;
11.12.b.5. Failure to maintain proper bonding; if for any reason a permittee fails to maintain proper bonding, the Secretary shall issue a cease and desist order and revoke the permit and the permittee shall become fully liable for the amount of the bond; or
11.12.b.6. Any cause which would require disqualification pursuant to this rule from receiving a permit upon original application.
11.12.c. Effect of Permit Suspension or Revocation.
11.12.c.1. Suspension. All infectious medical waste processing, treatment, storing or transfer activities and the receipt of any infectious medical waste at the facility shall cease immediately upon receipt of an order of suspension. Activities at the facility may recommence only after expiration of the order of suspension or upon revocation of that order by the issuing authority.
11.12.c.2. Revocation. All infectious medical waste processing, treatment, storing or transfer activities and the receipt of any infectious medical waste at the facility shall cease immediately upon receipt of an order of revocation. The facility owner shall submit either an application for a permit to close the facility or an application for a new commercial infectious medical waste facility permit within the time specified in the order of revocation.
11.12.c.3. Environmental Monitoring and Control. Environmental monitoring and control activities specified in an order of suspension or revocation shall continue at the commercial infectious medical waste facility for the duration of such order or until the authority that issued that order approves the cessation of such activities.
11.13. Transfer of Facility.
Permits issued by the Secretary are not transferable or assignable and shall automatically become invalid upon a change of ownership or upon suspension or revocation. An existing commercial facility that changes ownership may, however, continue to operate under the previous owners permit conditions until such time as the Secretary can process the new permit application required by this section, provided the new owner sends the Secretary a letter in which the new owner:
11.13.a. Advises the Secretary of such change of ownership including any management changes; and
11.13.b. Agrees to be bound by the conditions and policies established in the infectious medical waste management plan for that facility by the previous owner until such time as a new management plan can be approved by the Secretary.
11.14. Application Review. Within thirty (30) days of receipt of a permit application, compliance schedule, closure plan, or major modification application, the Secretary shall determine whether such application, schedule, or plan is complete and shall notify the applicant of his or her determination in writing. If the Secretary determines that such application, schedule, plan or modification is not complete, the notification shall advise the applicant of the deficiencies that require remedy.
11.14.a. The Secretary may not begin the evaluation of a permit before receiving a complete application, including any supplemental information requested.
11.14.b. The Secretary may not issue a permit before receiving a complete application.
11.14.c. The Secretary shall request formal comments from the county commission of the county in which the facility is proposed to be located and from any municipal government within two (2) miles of the proposed location, with any negative response to such application from any commission or municipal government to be considered by the Secretary and specific findings made as to the concerns raised by such responses.
11.15. Public Participation.
11.15.a. When the Secretary determines an application for a new facility to be complete, he or she shall conduct a public hearing in the county where the proposed facility is to be located.
11.15.b. When the Secretary determines an application for a major modification to be complete, he or she shall instruct the applicant or permittee to give public notice. The Secretary shall conduct a public hearing in the county where the proposed facility is to be located whenever he or she receives a request.
11.15.c. Public hearings shall be conducted in accordance with the following guidelines:
11.15.c.1. Public notice of a public hearing shall be given at least thirty (30) days before the hearing. Public comment will be accepted during those thirty (30) days.
11.15.c.2. Public notice shall be given by the applicant publishing the public notice as a Class II legal advertisement in a qualified newspaper, as defined in W. Va. Code § 59-3-1, serving the county where the facility will be located. The Secretary shall also require that legal advertisement be placed in newspapers of adjacent counties when a proposed facility is within two (2) miles of a county line. The cost of the publication will be the responsibility of the applicant who shall send a certification of publication to the Secretary within twenty (20) days after publication; and any other method reasonably calculated to give actual notice of the action in question to the persons potentially affected by it, including press releases or any other forum or medium to elicit public participation.
11.15.d. All public notices issued shall contain the following information:
11.15.d.1. The name and address of the office processing the permit action for which notice is being given;
11.15.d.2. The name, address and email address of the permittee or permit applicant, and if different, of the facility or activity regulated by the permit;
11.15.d.3. A description of the activities covered in the application, including the type of commercial infectious medical waste facility, the types, amounts, and origins of infectious medical wastes to be handled, site improvements, and infectious medical waste handling methods;
11.15.d.4. The name, address, telephone numbers and email address of a person from whom interested persons may obtain further information, including copies of the application;
11.15.d.5. A brief description of the comment procedures and the date, time and place of the hearing, and other procedures by which the public may participate in the final permit decision;
11.15.d.6. A general description of the location of proposed permit area including streams;
11.15.d.7. A clear and accurate location map. A map of a scale and detail found in the West Virginia official state highway map is the minimum standard for acceptance. The map size shall be at a minimum two (2) inches by two (2) inches. Longitude and latitude lines and a north arrow shall be indicated on the map, and such lines will cross at or near the center of the proposed permit area;
11.15.d.8. A reference to the date of previous public notices relating to the permit;
11.15.d.9. For major modifications, the public notice shall state:
11.15.d.9.A. That any interested person may submit written comment on the application, and that such comments shall include a concise statement of the nature of the issues raised;
11.15.d.9.B. That any interested person may request a public hearing, and that such request shall include a concise statement of the nature of the issues raised; and
11.15.d.9.C. That the Secretary shall conduct a public hearing in the county where the proposed facility is to be located whenever he or she receives a request.
11.15.e. The availability of the application shall include, but not be limited to, copies placed at the courthouse of the county in which the facility is to be located, the city or town hall of any municipal government within two (2) miles of the proposed location of the facility and all public libraries in the county;
11.15.f. Copies of the application shall be available from the Secretary.
11.15.g. An official transcript of the hearing shall be available to the public from the Secretary.
11.15.h. Any person may submit oral or written statements and data concerning the proposed facility. Reasonable limits may be set on the time allowed for oral statements, and the written statements shall be submitted no later than ten (10) days after the close of public hearings.
11.15.i. If any data, information or arguments submitted during the public comment period raise substantial new questions concerning the proposed facility, the Secretary shall:
11.15.j.1. Reopen or extend the public comment period to give interested persons an opportunity to comment on the information or argument submitted; or
11.15.j.2. Require an additional public hearing.
11.15.k. The applicant for a permit for a commercial infectious medical waste management facility shall maintain a public participation file. This file shall contain all the written comments received during the public comment period, copies of minutes of all meetings held by the applicant and a copy of the applicants written response to all written comment letters received during the written response period. This file shall be submitted to the Secretary by the applicant at the end of the comment period.
11.15.1. Based on comments received at the public hearing or upon written recommendations received, the Secretary may within thirty (30) days after the close of the public comment period, require the person who submitted the application to furnish additional information regarding the impact the siting of the proposed facility may have upon wetlands, endangered or threatened species of plants and animals, surface waters, underground waters, air quality, and other matters as determined by the comments received.
11.16. Permit Decision and Effective Date of Permit.
11.16.a. Within thirty (30) days of the close of the public comment period on an application for a new facility, or major modification of an existing permit, the Secretary shall respond in writing to the comments received.
11.16.b. After comments have been responded to, the Secretary shall issue a final permit decision. The Secretary shall provide written notification of his or her decision to the applicant and to each person who has submitted written comments or requested notice of the final permit decision.
For the purposes of this section, a "final permit decision" means the final decision of the Secretary to grant, deny, revoke and reissue, or terminate a permit.
11.16.c. In the case of an application for a new facility, the Secretary shall grant or deny the application as filed and as made available to the public pursuant to the provisions of this section. The Secretary shall provide the reasons therefor in his or her written notification to the applicant. This notification shall also include reference to the procedures for appealing the final permit decision.
11.16.d. The Secretary may refuse to grant a permit for any of the following reasons:
11.16.d.1. If an applicant or permittee has attempted to obtain or renew a permit by means of fraud, deceit or material misrepresentation;
11.16.d.2. Discovery of failure in the application or during the permit issuance process to fully disclose all significant facts or the permittee's misrepresentation of any significant fact at any time; or
11.16.d.3. The Secretary determines, based on comments and recommendations received, that the facility is incompatible with existing or proposed land use patterns, including, but not limited to: transportation facilities; public water supplies; water resources; agricultural, commercial and residential real estate values; aesthetics; socioeconomic conditions generally; or if it endangers public health, safety or well-being.
11.16.e. A final permit decision shall become effective not less than thirty (30) days after the date of notice of the decision, unless an earlier date is requested by the applicant and agreed upon by the Secretary.
11.17. A retailer of sharps to be used by individuals in their own medical treatment may establish a small commercial infectious medical waste management facility to be used solely for the treatment of sharps sold by and returned to the retailer for treatment. Such small commercial infectious medical waste management facility shall apply for and obtain a permit according to the provisions of
Section 4 of this rule. In addition to the requirements of Section 4, the application shall include a letter describing the location and estimated volume of sharps to be treated and a certified letter from an approved solid waste disposal facility agreeing to accept the treated waste. Such small commercial infectious medical waste management facility shall comply with Sections 6 and 10 of this rule, and may be exempted by the Secretary from the requirements of Sections 11.9 through 11.17 of this rule.
W. Va. Code R. § 64-56-12 Requirements Related to Manifests or Shipping Documents
12.1. Except as specified in Section 12.10.of this rule, the generator of infectious medical waste that is to be transported off-site for storage or treatment shall initiate a multi-part manifest or shipping document which is available from or approved by the Secretary.
12.1.a. If a multi-part written manifest or shipping document is utilized, copy three (3) shall be retained by the generator after acceptance by the transporter. Copy two (2) shall be retained by the transporter after acceptance by the treatment facility. Copy one (1) shall be retained by the treatment facility. The treatment facility shall forward the original to the generator as required by Section 12.8 of this rule.
12.1.b. If an electronic manifest or shipping document is utilized, the transporter shall provide the generator with a printed service receipt acknowledging that the transporter has accepted the waste from the generator and the date of acceptance. The transporter shall retain an identical printed service receipt throughout transport. Within fifty (50) days after the date the medical waste was accepted by the transporter, an electronic service receipt shall be made available to the generator. If the generator does not obtain access to an electronic service receipt within fifty (50) days after the date the medical waste was accepted by the transporter, the generator shall report this fact to the Secretary.
12.2. If the generator does not receive the completed manifest or shipping document from the treatment facility within fifty (50) days after the date the medical waste was accepted by the transporter, the generator shall report this fact to the Secretary.
12.3. A transporter who commingles loads shall initiate a new manifest or shipping document.
12.4. A transporter shall not accept infectious medical waste from a generator unless the waste is accompanied by a manifest or shipping document with the generator portion signed by the generator.
12.5. A transporter shall in the presence of the generator or, in the event of multiple transporters, in the presence of the previous transporter, sign the transporter portion of the manifest or shipping document and provide the generator or previous transporter with a signed copy of the manifest or shipping document.
12.6. An infectious medical waste management facility shall not accept more than fifty (50) pounds of infectious medical waste from a generator per month or any quantity of infectious medical waste from a transporter unless it is accompanied by a properly completed manifest or shipping document.
12.7. If a multi-part written manifest or shipping document is utilized, an infectious medical waste management facility shall, in the presence of the generator or transporter, complete the appropriate transport or storage, treatment or disposal facility portion of the manifest or shipping document, including a handwritten acceptance signature and date of acceptance, and immediately give a signed copy to the generator or transporter, with any discrepancies in information noted on the manifest or shipping document copy.
12.8. If a multi-part written manifest or shipping document is utilized, the infectious medical waste treatment facility shall record on the manifest or shipping document the date on which the shipment was received and accepted by the facility.
12.9. The infectious medical waste treatment facility shall keep one (1) copy of the completed manifest or shipping document as part of the facility operating record and, if a multi-part written manifest or shipping document is utilized, shall forward the original to the generator within seven (7) days after treatment.
12.10. Small quantity generators who elect to transport their own infectious medical waste are not required to use a manifest or shipping document, but shall meet the requirements in section 12.11 of this rule.
12.11. In instances when an infectious medical waste management facility accepts less than fifty (50) pounds of infectious medical waste from a small quantity generator, the facility shall maintain a log of such receipts which includes, at a minimum, the following:
12.11.a. The name and address of the generator;
12.11.b. The weight of the waste received;
12.11.c. The date of receipt of the waste; and
12.11.d. The signature of the person receiving the waste.
12.12. Manifests or shipping documents and logs shall be retained by all parties for a period of not less than three (3) years. The period of retention of records is extended automatically during the course of any unresolved enforcement action regarding the regulated activity or as requested by the Secretary. These records shall be available for inspection by the Secretary upon request.
12.13. Nothing in this rule shall prevent any hospital or other facility which receives infectious medical waste from any small quantity generator, including any ambulance company, from requiring a completed manifest or shipping document as more fully described in Sections 12.1 through 12.6 of this rule.
W. Va. Code R. § 64-56-13 Record Keeping and Reporting
13.1. All pertinent records required by this rule shall be retained for a period of not less than three (3) years.
13.2. The period of retention established in Section 13.1 of this rule shall extend automatically during the course of any unresolved enforcement action regarding the regulated activity or as requested by the Secretary.
13.3. All records shall be made available for inspection and or duplication by the Secretary or his or her duly authorized representative upon request.
13.4. All generators, except small quantity generators and those listed in Section 2 of this rule, commercial storage and transfer facilities and treatment facilities shall submit a report annually covering the preceding calendar year to the Secretary in a format specified by the Secretary by the twentieth (20th) day of January and additional reports at such times the Secretary judges necessary setting out the quantity of waste generated during a particular time period and the disposition of the infectious medical waste. Transporters shall submit these reports on a quarterly basis. A late fee of $25.00 or 10% of the permit fee, which is ever greater, will be assessed to those facilities that fail to submit a required annual report on or before the twentieth (20th) day of January of each year.
W. Va. Code R. § 64-56-14 Inspections; Right of Entry; Sampling; Reports and Analyses; Subpoenas
Inspections and other monitoring activities are required to be conducted according to the provisions of W. Va. Code §§ 22-18-13 and 20-5J-7 which are outlined in this section.
14.1. Upon the presentation of proper credentials and at reasonable times, the Secretary has the
authority to enter any building, property, premises, place, vehicle or permitted facility where infectious medical waste is or has been generated, handled, treated, stored, transported or disposed of for the purpose of promptly investigating any person's compliance with the provisions of relevant State law, this rule or permits issued under this rule.
14.2. The Secretary is required to make periodic inspections of every permitted facility as necessary to effectively implement and enforce the requirements of relevant State law, this rule or permits issued in accordance with this rule. After an inspection is made, a report is to be prepared and filed with the Secretary. A copy of the inspection report is required to be promptly furnished to the person in charge of the building, property, premises, place, vehicle or facility. All inspection reports are available to the public in accordance with the provisions of W. Va. Code § 29B-1-1 et seq.
14.3. Whenever the Secretary has cause to believe that any person is in violation of any provision of relevant State law, this rule, any condition of a permit issued by the Secretary, or any order issued under this rule, he or she is required to immediately order an inspection of the building, property, premises, place, vehicle or permitted facility at which the alleged violation is occurring.
14.4. Upon presentation of proper credentials and at reasonable times, the Secretary has the
authority to enter any establishment, building, property, premises, vehicle or other place maintained by any person where infectious medical waste is being or has been generated, transported, stored, treated or disposed of to inspect and take samples of wastes and the contents of any containers or labeling for such wastes. A receipt describing such samples, and, if requested, a portion of such sample equal in volume or weight to the portion retained is to be given to the owner, operator or agent in charge prior to the sample being taken from the premises. The Secretary is required to provide a copy of any analysis to the owner, operator or agent in charge promptly.
14.5. Upon presentation of proper credentials and at reasonable times, the Secretary is to be given access to all records relating to the generation, transportation, storage, treatment or disposal of infectious medical waste in the possession of any person who generates, stores, treats, transports, disposes of, or otherwise handles or has handled such waste. The Secretary is to be furnished with copies of all such records or given the records for the purpose of making copies. If the Secretary, upon inspection, investigation or through other means, observes or learns of a violation or probable violation of relevant State law or this rule, he or she is authorized to issue subpoenas and subpoenas duces tecum and to order the attendance and testimony of witnesses and to compel the production of any books, papers, documents, manifests and other physical evidence pertinent to such investigation or inspection.
W. Va. Code R. § 64-56-15 Enforcement Orders; Related Hearings; Permit Reinstatement
Enforcement orders and related hearings are required to be conducted according to the provisions of W. Va. Code §§ 22-18-15, 20-5J-8 and 29A-5-1 et. seq. as outlined in Sections 15.1 and 15.2 of this rule.
15.1. If the Secretary, upon inspection, investigation or through other means observes, discovers or learns of a violation of the provisions of this rule or relevant State law or of any order or permit issued under this rule or such law by the Secretary, he or she may:
15.1.a. Issue an order stating with reasonable specificity the nature of the violation and requiring compliance immediately or within a specified time. An order under this section includes, but is not limited to, any or all of the following: orders suspending, modifying or revoking permits, orders requiring a person to take remedial action, or cease and desist orders;
15.1.b. Seek an injunction in accordance with W.Va. Code § 20-5J-9(b);
15.1.c. Institute a civil action in accordance with W. Va. Code § 20-5J-9(a); or
15.1.d. Request the attorney general or the prosecuting attorney of the county in which the alleged violation occurred to bring a criminal action in accordance with W. Va. Code § 22-18-16.
15.2. Any person issued a cease and desist order may file a notice of request for reconsideration with the Secretary not more than seven (7) days from the issuance of such order and shall have a hearing before the Secretary contesting the terms and conditions of such order within ten (10) days of the filing of such notice of a request for reconsideration. The hearing is conducted as required by State law and Section 19 of this rule. The filing of a notice of request for reconsideration shall not stay or suspend the execution or enforcement of such cease and desist order.
15.3. Any person whose permit issued under this rule has been suspended or revoked may, at any time, make application for reinstatement of the permit. After receipt of a written request, including a signed statement by the applicant that in his or her opinion the conditions causing the suspension of the permit have been corrected, the Secretary shall make an inspection or investigation of the applicant's operation. If the applicant complies with the provisions of this rule, the permit shall be reinstated.
15.4. The Secretary may suspend or revoke a permit if the permit has been obtained by means of fraud, deceit or material misrepresentation.
W. Va. Code R. § 64-56-16 Criminal Penalties
In addition to any civil penalties that may be assessed pursuant to section 17, violations of this
rule may be subject to criminal penalties pursuant to the provisions of W. Va. Code § 22-18-16.
W. Va. Code R. § 64-56-17 Civil Penalties
In addition to any criminal penalties for violations of this rule as provided in section 16, violations of this rule may also be subject to civil penalties pursuant to the provisions of W. Va. Code §§ 22-18-17 and 20-5J-9.
W. Va. Code R. § 64-56-18 Imminent and Substantial Hazards; Orders; Penalties; Hearings
18.1. Notwithstanding any provision of this rule to the contrary, the Secretary, upon receipt of information, or upon observation or discovery that the handling, storage, transportation, treatment or disposal of any infectious medical waste may present an imminent and substantial endangerment to public health, safety or the environment, has the authority to:
18.1.a. Request the attorney general or the appropriate prosecuting attorney to commence an action in the circuit court of the county in which the hazardous condition exists to immediately restrain any person contributing to such handling, storage, transportation, treatment or disposal to stop such handling, storage, transportation, treatment or disposal or to take such other action as may be necessary; or
18.1.b. Take other action under this section including, but not limited to issuing such orders as may be necessary to protect public health and the environment.
18.2. Any person who willfully violates, or fails or refuses to comply with, any order of the Secretary under Section 18.1 of this rule may, in an action brought in the appropriate circuit court to enforce such orders, be fined not more than five thousand dollars ($5,000) for each day in which such violation occurs or such failure to comply continues.
W. Va. Code R. § 64-56-19 Administrative Due Process
Except for an civil administrative penalty assessed pursuant to W. Va. Code § 22-18-17, persons adversely affected by the enforcement of this rule who desire a contested case hearing to determine any rights, duties, interests or privileges, must do so in a manner prescribed in Rules of Procedure for Contested Case Hearings and Declaratory Rulings, 64CSR1.
TABLE 64-56A ANNUAL INFECTIOUS MEDICAL WASTE MANAGEMENT FACILITY PERMIT AND OPERATOR REGISTRATION FEES
Type of Facility Fee A. Hospitals (Non-Commercial Treatment Facilities) 1 to 50 Beds $ 500.00 51 to 149 Beds 1,750.00 150 or More Beds 2,500.00 B. Commercial Infectious Medical Waste Management Facility 5,000.00 Small Commercial Infectious Medical Waste Management Facility for Sharps Only (As provided for in Section 11.19 of this rule)
150.00 C. Transportation Vehicles (Each)
D. Commercial Storage and Transfer Facility.
E. Other (Generating more than 50 pounds per month)
- Health Care Professionals 2. Independent Dialysis Centers 3. Independent Laboratories 4. Independent Rural Clinics 5. Nursing Homes 6. Other Long Term Care Facilities 7. Outpatient Surgery Centers F. Incinerator Operator Registration
25.00 G. Alternative treatment evaluation fee
500.00
Series 57 Clinical Laboratory Practitioner Licensure
W. Va. Code R. § 64-57-1 General
1.1. Scope. -- This legislative rule sets forth standards and procedures for the licensing of clinical laboratory practitioners and establishes penalties for the use of unlicensed persons to perform the work of clinical laboratory practitioners by healthcare facilities.
1.2. Authority. -- W. Va. Code §16-1-4, §16-1-11, and §16-5J-10.
1.3. Filing Date. -- April 13, 2026.
1.4. Effective Date. -- July 1, 2026.
1.5 Sunset Provision. -- This rule shall terminate and have no further force or effect on August 1, 2031.
1.6. Applicability. -- Except as otherwise provided in this rule, this rule applies to:
1.6.1. Clinical laboratory practitioners who perform moderate or high complexity clinical laboratory tests as categorized pursuant to the criteria established in 42 CFR 493.17 of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and
1.6.2. Clinical laboratory consultants, directors, supervisors, or testing personnel not otherwise excluded in subsection 1.6.3. who perform moderate or high complexity testing or manipulate and report data obtained from laboratories in West Virginia.
1.6.3. This rule does not apply to:
1.6.3.a. Any individual who performs only laboratory tests categorized as waived under the criteria set forth in 42 CFR 493.15 and approved by the FDA pursuant to 42 U.S.C. §263a for use in a waived setting;
1.6.3.b. Any physician, dentist, nurse practitioner, nurse midwife, or physician assistant, licensed within this state who performs only provider-performed microscopy procedures within the scope of his or her professional license and training pursuant to 42 CFR 493.19;
1.6.3.c. Any respiratory care provider licensed within the state who performs moderate complexity blood gas and/or hemoximetry testing within the scope of his or her professional license and training as follows:
1.6.3.c.1. Blood gases are limited to pH, pCO2, pO2, and sO2;
1.6.3.c.2. Oximetry is limited to total hemoglobin, hemoglobin fractions, and hematocrit;
1.6.3.c.3. Potassium, chloride, sodium, ionized calcium, glucose, and lactate; and
1.6.3.c.4. Calculations derived from the listed tests may be reported.
1.6.3.d. An individual who performs laboratory tests only on himself or herself or members of his or her family;
1.6.3.e. An individual employed as a clinical laboratory practitioner in an agency or organization exempt from licensure or CLIA certification in accordance with 42 CFR 493.3;
1.6.3.f. A medical doctor, doctor of osteopathy, or doctor of podiatry licensed to practice medicine, osteopathy, or podiatry in West Virginia;
1.6.3.g. A doctor of philosophy performing laboratory testing within the scope of his or her degree and board certification;
1.6.3.h. A clinical laboratory consultant, director, or supervisor who is not otherwise subject to one of the exceptions set forth in subsection 1.6.3. and does not perform moderate to high complexity testing or manipulate and report data obtained from laboratories in the state; and
1.6.3.i. An individual who strictly performs specimen collection, preparation, or processing but does not perform tests. These procedures may include, but are not limited to, accessioning aliquoting specimens into secondary containers and embedding, cutting, and staining paraffin block samples.
1.6.4. Laboratories that employ exempt testing personnel are directly responsible for verifying that the individual’s education, certification, and experience meet the minimum CLIA requirements for testing personnel set forth in 42 CFR 493.1423 and 42 CFR 493.1489, and maintaining documentation for inspection purposes. Laboratories must also maintain qualification documents for licensed individuals for inspection purposes.
1.6.5. A pharmacist with a PharmD licensed to practice in West Virginia practicing within the scope of their professional license.
1.7. Prohibition -- No person may perform any duty of a licensed clinical laboratory practitioner in the state, except where exempted in subsection 1.6.3., unless he or she is licensed by the Secretary as a clinical laboratory practitioner.
1.8. Enforcement. -- This rule is enforced by the Secretary of the West Virginia Department of Health.
W. Va. Code R. § 64-57-2 Definitions
2.1. Certifying agency -- Certifying agency means one of the following institutions:
2.1.1. American Society for Clinical Pathology (ASCP);
2.1.2. American Medical Technologists (AMT);
2.1.3. American Association of Bioanalysts (AAB);
2.1.4. American Board of Bioanalysts (ABB);
2.1.5. American Board of Clinical Chemistry (ABCC);
2.1.6. American Board of Forensic Toxicology (ABFT);
2.1.7. American Board of Medical Genetics and Genomics (ABMGG);
2.1.8. American Board of Medical Laboratory Immunology (ABMLI);
2.1.9. American Board of Medical Microbiology (ABMM);
2.1.10. American College of Histocompatibility and Immunogenetics (ACHI); and
2.1.11. National Registry of Certified Chemists (NRCC).
2.2. CLIA. -- Clinical Laboratory Improvement Amendments of 1988, Section 353 of the Public Health Service Act, 42 CFR Part 493.
2.3. Clinical Laboratory. -- A facility certified by CLIA to perform clinical testing for the purpose of determining, measuring, or otherwise describing the presence or absence of various substances or organisms in the body for the diagnosis, prevention or treatment of any disease, or the impairment of, or the assessment of the health of human beings.
2.4. Clinical Laboratory Consultant. -- A person who meets the qualifications for:
2.4.1. Moderate complexity testing technical consultant found at 42 CFR 493.1411;
2.4.2. Moderate complexity testing clinical consultant found at 42 CFR 493.1417; or
2.4.3. High complexity testing clinical consultant found at 42 CFR 493.1455.
2.5. Clinical Laboratory Director. -- A person who:
2.5.1. Provides overall management and direction of a clinical laboratory; and
2.5.2. Meets the qualifications for:
2.5.2.a. Moderate complexity testing laboratory director found at 42 CFR 493.1405; or
2.5.2.b. High complexity testing laboratory director found at 42 CFR 493.1443.
2.6. Clinical Laboratory Practitioner. -- Includes high complexity testing personnel, point of care technicians, cytotechnologists, histologists, pathologist assistants, and trainees.
2.7. Clinical Laboratory Supervisor. -- A person who meets the qualifications for:
2.7.1. A high complexity testing technical supervisor found at 42 CFR 493.1449;
2.7.2. A high complexity testing general supervisor found at 42 CFR 493.1461; or
2.7.3. A high complexity testing cytology general supervisor found at 42 CFR 493.1469.
2.8. Commission on Accreditation of Allied Health Programs (CAAHEP) -- The accrediting organization for cytology educational programs, recognized by the Council for Higher Education Accreditation.
2.9. Cytotechnologist (CT). -- A laboratory practitioner meeting CLIA requirements set forth in 42 CFR 493.1483 who performs the responsibilities set forth in 42 CFR 493.1485, which include examining and interpreting cytology slide preparations under the supervision of a cytology technical or general supervisor and documenting the number of slides reviewed and hours spent examining slides in each 24-hour period.
2.10. Department. -- The West Virginia Department of Health.
2.11. Grossing. -- The pathological inspection, description, measurement, sectioning, and evaluation of human tissue specimens.
2.12. High Complexity Testing Personnel (HCTP). – A laboratory practitioner meeting CLIA requirements set forth in 42 CFR 493.1489 who performs the responsibilities set forth in 42 CFR 493.1495, which include a broad range of high complexity tests and other tasks requiring the exercise of judgment and responsibility, commensurate with the individual’s education, training, or experience in a clinical laboratory.
2.13. Histologist (H) -- A laboratory practitioner with the education, skills, and training to perform high complexity pathology specimen grossing, inking, and mapping, and associated special staining procedures or tissue analysis under the direct supervision of a pathologist or pathologist assistant.
2.14. Laboratory Test. -- The clinical examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of human beings.
2.15. National Accrediting Agency for Clinical Laboratory Science (NAACLS) -- The accrediting organization for laboratory science-related educational programs, recognized by the Council for Higher Education Accreditation.
2.16 Pathologist Assistant (PA) -- A practitioner with advanced education and training who performs a variety of pathology tests, including comprehensive macroscopic examination and evaluation (grossing) of surgical pathological specimens, under the supervision of a pathologist.
2.17. Point of Care Technician (POCT). -- A laboratory practitioner meeting CLIA requirements set forth in 42 CFR 493.1423 to perform moderate complexity tests commensurate with the individual’s education, training or experience, and technical abilities set forth in 42 CFR 493.1425 in a clinical laboratory under the supervision of a clinical laboratory director, consultant, or supervisor. Supervision shall be available at all times when testing is being performed.
2.18. Trainee (T) -- An individual who has obtained appropriate education to perform high-complexity laboratory testing but lacks the required certification and/or experience for a regular HCTP license. Trainees may only perform tests under the personal supervision of a clinical laboratory director, consultant, or supervisor. Supervision must be available at all times when testing is being performed.
W. Va. Code R. § 64-57-3 Incorporation by Reference
3.1. The following provisions of 42 CFR Part 493, laboratory requirements November 28, 2024 are hereby incorporated by reference:
3.1.1. 42 CFR 493.3;
3.1.2. 42 CFR 493.17;
3.1.3. 42 CFR 493.19;
3.1.4. 42 CFR 493.1405;
3.1.5. 42 CFR 493.1411;
3.1.6. 42 CFR 493.1417;
3.1.7. 42 CFR 493.1423;
3.1.8. 42 CFR 493.1425;
3.1.9. 42 CFR 493.1443;
3.1.10. 42 CFR 493.1449;
3.1.11. 42 CFR 493.1455;
3.1.12. 42 CFR 493.1461;
3.1.13. 42 CFR 493.1469;
3.1.14. 42 CFR 493.1483;
3.1.15. 42 CFR 493.1485;
3.1.16. 42 CFR 493.1489 ; and
3.1.17. 42 CFR 493.1495.
W. Va. Code R. § 64-57-4 Limitation
4.1. A license shall only be issued to an individual currently residing in the United States unless he or she can provide documentation of sponsorship and a valid contract to perform laboratory testing at a facility in the state. Licenses will be issues directly to the sponsoring agency or employer.
4.2. Students in a clinical laboratory training program must obtain a T license before beginning clinical rotations within the State.
4.3. Individuals may not obtain clinical training, perform laboratory tests, or report results until the appropriate license is obtained.
W. Va. Code R. § 64-57-5 Documentation, Qualifications, Renewal, License Duration, and Fees
5.1. General. -- Applicants for licensure under this rule shall submit an application form available online at https://dhhr.wv.gov/ols/regulatory/Pages/Licensure.aspx and the following materials:
5.1.1. Initial applications shall include documentation of the applicant’s credentials applicable to the license type as outlined in this section.
5.1.1.a. All initial applications shall be accompanied by documentation of education obtained. If the relevant education was obtained in a post-secondary setting, a transcript is required.
5.1.1.a.1. If the relevant education was obtained outside of the United States, the applicant shall provide documentation that each course and degree was verified for equivalency by a foreign equivalency evaluation service.
5.1.1.b. Documentation of training and experience received shall be provided by the method determined by the Secretary at the time of application.
5.1.1.c. All documentation relating to education, training, and experience shall identify the applicant and the issuing entity.
5.1.2. The annual license fee of $25 per person as authorized by W. Va. Code §16-5J-10 and any other special circumstance fees as required by subsection 5.10.
5.2. Upon initial application for a HCTP license, the applicant shall provide documentation to establish that he or she qualifies via one of the following routes:
5.2.1. Has earned an associates, bachelors, masters, or doctoral degree, or completed post-baccalaureate training in laboratory technology/science at a National Accrediting Agency for Clinical Laboratory Science (NAACLS) accredited program, or has earned a bachelors, masters, or doctoral degree, or equivalent as defined by CLIA, in a chemical or biological science from an accredited institution; and
5.2.1.a. Has obtained certification from a certifying agency identified in subsection 2.1 of this rule; or
5.2.1.b. Has obtained at least one year of documented training and/or experience in a laboratory certified by CLIA to perform high complexity testing that provided the skills necessary to accurately perform testing. A minimum of three months of training or experience must have been obtained within each specialty or subspecialty of testing performed. Training in each specialty may be obtained simultaneously or consecutively.
5.2.2. Has successfully completed 60 semester hours of academic credit at an accredited institution which includes, at a minimum, either 24 semester hours of medical laboratory technology/medical laboratory science courses or six semester hours of chemistry, six semester hours of biology, and 12 additional semester hours of chemistry, biology, or medical laboratory technology/medical laboratory science, in any combination; and
5.2.3. Has obtained at least one year of documented training and/or experience in a laboratory certified by CLIA to perform high complexity testing that provided the skills necessary to accurately perform testing. A minimum of three months of training and/or experience must have been obtained within each specialty or subspecialty of testing performed. Training in each specialty may be obtained simultaneously or consecutively; or
5.2.4. Has successfully completed an official United States military medical laboratory procedures training course at least 50 weeks in duration and has enlisted in the military as a Medical Laboratory Specialist (Laboratory Technician).
5.3. Upon initial application for a CT license, the applicant must provide documentation to establish that he or she qualifies via one of the following routes:
5.3.1. Has graduated from a school of cytotechnology accredited by the CAAHEP; or
5.3.2. Has obtained certification as a CT from a certifying agency identified in subsection 2.1. of this rule.
5.4. Upon initial application for a PA license, the applicant shall provide documentation to establish that he or she has graduated from a NAACLS accredited pathologist assistant program and obtained certification as a pathologist’s assistant from a certifying agency identified in subsection 2.1 of this rule.
5.5. Upon initial application for an H license, the applicant shall provide documentation to establish that he or she qualifies via the following route:
5.5.1. Meets the education requirements set forth in subsection 5.2.1. or subsection 5.2.2. of this rule, at a minimum; and
5.5.1.a. Obtained certification as a histotechnologist or histotechnician from a certifying agency identified in subsection 2.1. of this rule; or
5.5.1.b. Has at least one year of pertinent full-time experience or training in the gross examination of human tissue specimens performed under the supervision of a pathologist.
5.6. Upon initial application for a POCT license, the applicant shall provide documentation to establish that he or she qualifies via the following route:
5.6.1. Has at least a high school diploma or equivalent approved by the state department of education,
5.6.2. Is employed or offered employment in a clinical laboratory certified by CLIA to perform moderate or high-complexity testing; and
5.6.3. Has written verification from the laboratory director or designee that the applicant will receive training designed to provide the skills required by CLIA with respect to the specific moderate complexity tests he or she will perform.
5.6.4. In the event that a POCT licensee performs tests in addition to those that he or she was initially trained to perform, the employer shall provide documentation of the relevant additional training.
5.7. Upon initial application for a T license, the applicant shall provide documentation to establish that he or she qualifies via one of the following routes:
5.7.1. Is employed or offered employment in a clinical laboratory certified by CLIA to perform high complexity testing; and
5.7.2. Meets one or more of the education requirements set forth in subsections 5.2.1. or 5.2.2. of this rule; and
5.7.3. Has not met the certification or training requirements listed in subsections 5.2.3., 5.4., and 5.5.1.b. of this rule; or
5.7.4. Is a student attending a NAACLS-accredited laboratory training program.
5.7.5. A T license may be renewed no more than twice and shall be issued at the discretion of the Secretary. A person may not be licensed as a trainee for more than three years.
5.8. An applicant for renewal of either a current or an expired license shall submit a renewal application, licensure fee of $25, and documentation of at least 10 hours of continuing education commensurate with the level of complexity of testing the individual performs, completed following the issuance of the most recent license. Acceptable continuing educational activities may include, but are not limited to, laboratory seminars, workshops, related college coursework, employer or vendor-provided in-service training, and credit-awarding continuing education courses.
5.8.1. The following activities are not accepted for continuing education:
5.8.1.a. Time spent conducting laboratory inspections as part of a survey team; and
5.8.1.b. Performance of proficiency testing unless continuing education credits are issued by the accrediting organization or proficiency testing provider.
5.9. Duration of License. -- A clinical laboratory practitioner license expires one year after the date it was issued. In the case of a license which has lapsed or been inactive for five years the individual shall comply with the requirements for issuance of an initial license as described in subsection 5.1. of this rule.
5.10. Additional fees are charged for the following:
5.10.1. A mandatory late fee of $10 for renewal applications that are submitted after the application due date.
5.10.2. An optional fee of $10 to print and mail a replacement license.
5.10.3. A mandatory fee of $20 for reinstatement of a lapsed license.
5.10.4. Any fees required for the use of online licensing systems including, but not limited to, convenience fees, transaction fees, and payment processing fees, as set by and paid to the software vendor or financial institution.
5.10.5. An optional “emergency” issuance fee of $35 to process an application or other request within three business days.
5.10.6 A penalty of $100 is assessed to any testing personnel identified as not having a valid license during a laboratory inspection, which is a violation of CLIA personnel requirements under 42 CFR 493.1423(a) and 493.1489(a). The penalty must be paid before a license can be issued or renewed.
5.10.7. A fee of $10 for official licensure source verification.
5.10.8. A fee of $35 for payments returned due to non-sufficient funds.
W. Va. Code R. § 64-57-6 Reciprocity
6.1. The Secretary may issue a clinical laboratory practitioner license to a person who holds a license or certification from another jurisdiction that has licensure and certification requirements at least as stringent as the requirements of this rule. Applicants for reciprocity shall submit with their initial application the license application fee, all required documentation, and a statement from their licensing or certifying jurisdiction that they are in good standing.
W. Va. Code R. § 64-57-7 Limitations on License and Use of Titles by Healthcare Facilities
7.1. Licensure as a clinical laboratory practitioner does not authorize the person to perform laboratory tests until the CLIA laboratory director has determined that the person is qualified by education, training, or experience required by 42 CFR 493.1423, 42 CFR493.1483, or 42 CFR 493.1489 to perform such tests.
7.2. Healthcare facilities may not use the terms cytotechnologist, point of care technician, high complexity testing personnel or abbreviations thereof, to refer to a person who is not licensed as a clinical laboratory practitioner. A facility is not prohibited from using the designations, variations, or abbreviations of medical laboratory technician, medical technologist, medical laboratory scientist, pathologist assistant, or histologist to describe, classify, and compensate its employees if the individual holds a valid HCTP license. Each facility is responsible for determining its personnel qualifications, which must be at least as stringent as federal CLIA requirements and this rule.
W. Va. Code R. § 64-57-8 Revocation and Non-issuance of Clinical Laboratory Practitioner Licenses
8.1. A clinical laboratory practitioner license shall not be issued or may be revoked if the applicant for or holder thereof:
8.1.1. Has misrepresented material facts in an application or has assisted another person in doing so;
8.1.2. Does not meet the requirements for licensure; or
8.1.3. Has been found to have intentionally falsified laboratory results or to have engaged in negligent laboratory practices.
8.2. The Secretary may consider reinstatement of a revoked license if the applicant can provide documentation of meeting the requirements of this rule: Provided, That no reinstatement is available for a license revoked pursuant to subsections 8.1.1. and 8.1.3.
W. Va. Code R. § 64-57-9 Hearings
9.1. A request for a hearing may be made to the secretary by an applicant for a clinical laboratory practitioner license, by a holder thereof, or by a healthcare facility. The request shall specify the grounds relied upon as a basis for the relief requested.
9.2. Hearings shall be conducted in accordance with the provisions of W. Va. Code § 29A-5-1 et seq., and Bureau’s Rules of Procedure for Contested Case Hearings and Declaratory Rulings, 64CSR1.
64CSR57
64CSR57
Series 59 Patient Rights at State-Operated Mental Health Facilities
W. Va. Code R. § 64-59-1 General
1.1. Scope. -- This legislative rule establishes the rights of patients of state-operated mental health facilities.
1.2. Authority. -- W. Va. Code §27-5-9(g).
1.3. Filing Date. -- April 8, 2026.
1.4. Effective Date. -- April 8, 2026.
1.5. Sunset Provision. -- This rule shall terminate and have no further force or effect on August 1, 2031.
1.6. Construction. -- This rule shall be liberally construed to effectuate the rehabilitative goals of Chapter 27 of the West Virginia Code, consistent with the protection of patient rights and dignity.
W. Va. Code R. § 64-59-2 Application and Enforcement
2.1. Application. -- This rule applies to state-operated mental health facilities that are licensed to provide inpatient psychiatric services.
2.2. Enforcement. -- This rule is enforced internally by the Secretary of the Department of Health Facilities or his or her designee, or externally by individual action.
W. Va. Code R. § 64-59-3 Definitions
3.1. Administrator. -- The chief executive officer of the mental health facility.
3.2. Chemical Restraint. – A drug or medication that is not used as a standard treatment for the patient’s medical or psychiatric condition or that is used solely as a means of coercion, discipline, convenience, or retaliation, and that results in restricting the patient’s freedom of movement.
3.3. Clinical/Medical director or chief medical officer. -- The person who has the responsibility for decisions involving clinical and medical treatment of patients in a mental health facility in accordance with W. Va. Code §27-1-7.
3.4. C.F.R. – References to the Code of Federal Regulations herein, and subsections thereto, refer to regulations in effect as follows:
3.4.1. 42 C.F.R. § 482.13, effective November 29, 2019;
3.4.2. 42 C.F.R. § 482.24, effective June 30, 2020;
3.4.3. 42 C.F.R. § 482.28, effective July 11, 2014;
3.4.4. 42 C.F.R. § 482.41, effective July 5, 2016;
3.4.5. 42 C.F.R. § 482.42, effective November 1, 2024;
3.4.6. 42 C.F.R. § 482.61, effective June 30, 2020; and
3.4.7. 42 C.F.R. § 482.62, effective October 26, 2007.
3.5. Facility. -- A state-operated mental health facility that treats patients as defined herein.
3.6. FDA Food Code. – The Federal Food Code, also known as the 2017 Recommendations of the United States Public Health Service, Food and Drug Administration, is published by the U.S. Food and Drug Administration. The FDA Food Code is accessible at https://www.fda.gov/food/fda-food-code/food-code-reference-system.
3.7. Individualized Treatment Plan (ITP). -- A treatment plan to promote the discharge of a patient that is prepared and maintained in accordance with 42 C.F.R. § 482.61.
3.8. Legal Representative. --
3.8.1. A conservator, temporary conservator or limited conservator appointed pursuant to the West Virginia Guardianship and Conservatorship Act, W. Va. Code, §44A-1-1 et seq., within the limits set by the order;
3.8.2. A guardian, temporary guardian or limited guardian appointed pursuant to the West Virginia Guardianship and Conservatorship Act, W. Va. Code, §44-1-1 et seq., within the limits set by the order;
3.8.3. An individual appointed as committee or guardian prior to June 9, 1994, within the limits set by the appointing order and W. Va. Code §44A-1-2(d);
3.8.4. A person having a medical power of attorney pursuant to the West Virginia Medical Power of Attorney Act, W. Va. Code §16-30-1 et seq., within the limits set by the law and the appointment;
3.8.5. A representative payee under the U.S. Social Security Act, Title 42 US Code § 301 et seq., within the limits of the payee's legal authority;
3.8.6. A surrogate decision-maker appointed pursuant to the West Virginia Health Care Surrogate Act, W. Va. Code §16-30-1 et seq., or the West Virginia Do Not Resuscitate Act, §16-30C-1 et seq., within the limits set by the appointment;
3.8.7. An individual having a durable power of attorney pursuant to W. Va. Code §39B-1-101 et seq., or a power of attorney under common law, within the limits of the appointment; or
3.8.8. An individual lawfully appointed in a similar or like relationship of responsibility for a patient under the laws of this state, or another state or legal jurisdiction, within the limits of the applicable statute and appointing authority;
3.8.9. If a legal representative has been appointed for or designated by any patient as having the authority to exercise on behalf of the patient one or more of the patient’s rights under this rule, the facility shall permit the individual's legal representative to act on behalf of the individual and to exercise the authority to the extent granted to the legal representative in the order or other document naming the legal representative or pursuant to the statute authorizing the legal representative and to the extent that the legal representative's acts are not hostile or adverse to the best interests of the patient. A legal representative may authorize the use of medications recommended or suggested by the Clinical/medical director. This provision does not relieve the facility of the responsibility of informing the individual patient as required by this rule, to the extent that the individual is capable of understanding the matter, nor does it in any way deprive the patient of his or her legal rights granted under this rule or state or federal law or rules and regulations. If the patient has a legal representative, the name, address and telephone number of the legal representative shall be recorded in the patient’s financial and clinical records, as applicable, along with the nature and scope of the authority granted to the legal representative by order, appointment or law. The facility shall also maintain a copy of the document documenting or designating the legal representative. The facility administrator and staff should note that the various types of legal representatives do not necessarily have the lawful authority to act on behalf of the resident in all matters which may require action by a legal representative. For example, a conservator may have responsibility for financial affairs, but not personal affairs, such as medical care.
3.9. Mechanical Restraints. -- Restraining devices of any type or form in accordance with 42 C.F.R. § 482.13(e). Restraining devices used solely as a means of coercion, discipline, convenience, or retaliation are prohibited.
3.10. Mental Health Facility. -- A state-operated psychiatric hospital that is accredited by The Joint Commission and licensed in accordance with W.Va. C.S.R. §64-12-1 et seq.
3.11. Neglect. -- Actions of omission or commission within the meaning of W. Va. Code §9-6-1(4), that violate 42 C.F.R § 482.13, or that constitute a breach of the applicable standard of care, including the failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness.
3.12. Patient. -- Any individual receiving treatment or services in or from a mental health facility who has been committed to the facility in accordance with W. Va. Code §27-5-1 et seq., or W. Va. Code §27-6A-1 et seq., or both.
3.13. Physical Abuse. -- Actions of omission or commission within the meaning of W. Va. Code §9-6-1(3), that violate 42 C.F.R. § 482.13, or that constitute a breach of the applicable standard of care. Physical abuse includes, but is not limited to, the infliction or threat to inflict physical pain or injury on, or the imprisonment of any patient, including pain associated with mental abuse, verbal abuse, sexual abuse, involuntary seclusion or any physical or chemical restraint not required to treat the patient’s clinical symptoms, regardless of the patient’s ability to understand or recognize the abuse or the willful infliction of injury, unreasonable confinement, intimidation, or punishment, with resulting physical harm, pain, or mental anguish, including staff neglect or indifference to infliction of injury or intimidation of one patient by another.
3.14. Seclusion. -- Actions or conduct defined by 42 C.F.R. § 482.13. Seclusion used solely as a means of coercion, discipline, convenience, or retaliation is prohibited.
3.15. Secretary. -- The Secretary of the West Virginia Department of Health Facilities.
3.16. Sexual Harassment. -- Physical advances or, nonverbal conduct that is sexual in nature that is either: (1) unwelcome, offensive, or creates a hostile environment, when the staff member is aware or has been informed that his or her conduct falls into one of these categories; or (2) is sufficiently severe or intense to be abusive to a reasonable person in the particular context.
3.17. State Operations Manual. – The State Operations Manual Appendix A – Survey Protocol, Regulations and Interpretive Guidelines for Hospitals published by the Centers for Medicare and Medicaid Services, Rev. 220, 04-19-24. The State Operations Manual is accessible at https://www.cms.gov.
3.18. Verbal Abuse. -- Conduct that violates 42 C.F.R. § 482.13 or that constitutes a breach of the applicable standard of care. Verbal abuse includes, but is not limited to, the use of oral, written or gestured language or tone that is disparaging, frightening, humiliating, and/or derogatory to patients or their families, or within their hearing distance, regardless of their age, ability to comprehend, or disability.
W. Va. Code R. § 64-59-4 Adoption of Other Standards
Notwithstanding anything herein to the contrary, the relevant portions of Conditions of Participation for Hospitals, 42 CFR Part 482, Subparts A through E; the State Operations Manual; and the accreditation standards for hospitals of the Joint Commission shall control: Provided, That to the extent there is a conflict between the federal regulations or the accreditation standards and the standards specified in this rule, the more stringent standard applies, except that, if there is a conflict between a standard set forth in this rule and a federal standard required for purposes of certification for participation in Medicare or Medicaid, or a standard or requirement for purposes of accreditation by the Joint Commission, the relevant federal standard or accreditation standard or requirement shall supersede any provision in this rule.
W. Va. Code R. § 64-59-5 Patients’ Rights Generally
5.1. Persons with behavioral health problems are more likely to have their human and civil rights denied because of their condition. Consequently, special attention and effort are required to assure that these human and civil rights are exercised and protected in all behavioral health services.
5.2. No Discrimination. All mental health facilities shall make available all services to persons in need without discrimination because of race, creed, color, sex, age, national origin, marital status, lack of wealth, disability, or duration of residence.
5.3. Civil Rights of Patients. Every patient served by any facility operated by the Department shall be permitted to exercise all of his or her civil rights, including but not limited to: civil service status and appointment; the right to register and vote at elections; the right to acquire and dispose of property; the right to execute instruments or rights relating to the granting, forfeiture or denial of a license, permit, privilege or benefit pursuant to any law; the right to enter into contractual relationships, to marry or to obtain a divorce; or the right to hold a professional, occupational or vehicle operator's licenses, unless he or she has been appointed a legal representative and the court has made a specific finding that the patient is incompetent to exercise the specific right or category of rights.
5.4. Responsibility of Administrator. It is the responsibility of the mental health facility's administrator to assure that each patient is informed of his or her rights and to make all necessary arrangements to allow the patient to exercise his or her rights.
5.5. Patients’ Rights in A Facility or Group Setting Generally. Patients shall be housed with other patients of similar age and activity levels when space permits and the treatment team determines that such placement is appropriate.
5.6. Right to Least Restrictive Residential Setting. The patient has the right to access treatment in the least restrictive setting that provides the most appropriate level of care. The goal of treatment for a patient shall be to address needs so as to permit the patient to be in the least restrictive setting.
5.7. Right of Privacy. A patient has a right to as much privacy as the area in which he or she is residing will allow, and the right to move about freely unless his or her safety is threatened or otherwise clinically contraindicated.
5.8. No Deprivation of Rights as Punishment. No patient can be deprived of a right provided by law or regulation as punishment. No patient may be deprived of a right unless otherwise clinically indicated and, if so, then only for so long as is necessary to permit correction of the situation, behavior, or clinical needs of the patient.
5.9. Every patient, upon his or her admission to a mental health facility, and at any later time upon request, shall be given a summary of the rights afforded by this rule and as required by 42 C.F.R. § 482.13. A copy of this rule shall be posted in a prominent public place in each facility. Further, the administrator or his or her designee shall confer periodically with the patient advocates and collaboratively develop a brief summary of patient rights for distribution to patients.
W. Va. Code R. § 64-59-6 Patients’ Right to Treatment
6.1. General. All patients of mental health facilities have a right to treatment in the least restrictive setting in an outpatient community-based program to the extent resources and programs are available, and are further entitled to reasonable and available care and treatment that will promote the discharge of patients to the least restrictive setting. Treatment shall be provided in accordance with the relevant parts of 42 C.F.R. § 482 and the State Operations Manual.
6.2. Prohibition on Admission for Confinement. No individual shall be admitted to or detained in a mental health facility for the sole purpose of confinement except as otherwise permitted by law.
6.3. Trained and Competent Personnel. All care and treatment must be provided by qualified personnel and staff in accordance with 42 C.F.R. § 482.62.
6.4. Periodic Psychiatric Evaluation. Unless the patient’s clinical condition requires otherwise, every patient of a mental health facility has the right to a psychiatric evaluation consistent with the applicable standard of care no less frequently than once every three months: Provided, That the initial psychiatric evaluation of each patient admitted to a mental health facility shall be conducted within 60 hours of the patient’s admission in accordance with 42 C.F.R. § 482.61(b).
6.5. Appropriate Treatment, Program Plan, Treatment Planning, and Discharge Planning Based on Examination and Diagnosis. Every patient of a mental health facility has a right to treatment based on appropriate examination and diagnosis by a staff member operating within the scope of his or her professional license. All evaluations, program plans, initial treatment plans, master treatment plan, treatment, clinical care, development of assessment and diagnostic data, recordation of clinical progress, and discharge planning shall be done in accordance with 42 C.F.R. § 482; the State Operations Manual; and consistent with the applicable standard of care.
6.6. Accepted Standards. All care and treatment provided to each patient shall be provided in accordance with the applicable standard of care. Any care or treatment that deviates from the applicable standard of care or is inconsistent with 42 C.F.R. § 482 shall be specifically noted in the patient’s medical record.
W. Va. Code R. § 64-59-7 Medical and Dental Care, Other Therapies, and Informed Consent
7.1. Physical Examination. All patients in a mental health facility shall have a physical health examination at least every six months and shall receive treatment and care for physical illness consistent with the standard of care.
7.2. Freedom from Unnecessary Medication. All patients of mental health facilities have a right to be free of non-standard of care or non-FDA approved medication unless otherwise clinically indicated.
7.3. Limits on Use of Medication. A medication shall not be used as punishment, for the convenience of staff, or as a substitute for a program of treatment, or in quantities that interfere with the patient’s treatment program: Provided, That nothing in this rule prohibits the use of medication that is clinically indicated and prescribed consistent with the applicable standard of care to manage the patient as clinically necessary or to promote the discharge of the patient, or both.
7.4. Medication Explained to Patient. The use of medication shall be fully explained to patients, and documentation of these explanations made part of the treatment team member's documentation and progress notes.
7.5. Dental Care. Dental care including screening and treatment shall be provided for any patient with a length of stay greater than six months in a state hospital, and when identified as a need by the patient’s treatment team.
7.6. Speech Pathology, Audiology, Language Therapy. Speech, language and audiology screening, evaluation and therapy services shall be conducted and provided by qualified clinicians when clinically indicated for a patient.
7.7. Physical and Occupational Therapy. Physical and occupational therapy screening, evaluation and therapy services shall be conducted and provided by qualified clinicians when clinically indicated for a patient.
7.8. Voluntary Patients and Non-Committed Patients’ Consent to Treatment. No treatment may be given to any voluntary patient who has not been formally committed by final proceedings pursuant to W. Va. Code §27-5-4, §27-6A-2(b) or §27-6A-3 without his or her written consent. The consents shall be obtained as a part of the admission package. If no informed consent is documented in the chart, the physician or person prescribing treatment shall provide such information to the patient before treatment is begun.
7.9. Consent to Treatment When Admitted for Examination. Except with respect to psychiatric emergencies, an individual has a right to refuse treatment. Individuals are sometimes admitted to a mental health facility under "custody for examination" procedures in which treatment could be provided to the individuals with minimal risk, but the individuals, due to their mental condition, do not refuse treatment but also are not able to give informed consent to the treatment. In some instances, conditions exist which, if not treated, reasonably can be expected to cause permanent damage or severe pain. Treatment provided under such circumstances shall be done only if consistent with the applicable standard of care and the needs of the patient.
7.9.1. There is no statutory authority to provide treatment prior to actual commitment in the absence of informed consent. The procedures outlined in this rule are provided for use only when: (1) treatment is not refused; (2) no informed consent is forthcoming; (3) the risk of harm from failure to treat is demonstrably greater than the risks from treatment; and (4) the individual is unable to make any judgment to consent or refuse treatment.
7.9.2. When an individual is admitted to a mental health facility under "custody for examination," the individual shall be evaluated without the use of medication. If, as the result of the examination, it is determined that the individual does exhibits signs and symptoms of psychiatric or other illnesses for which a recognized, commonly accepted course of treatment can be prescribed, the staff performing the evaluation shall follow the following procedures:
7.9.2.a. Determine whether the individual is clinically competent to understand the nature and purpose of the proposed treatment, as well as its prospective benefits and possible side effects. Both the examining physician and the patient advocate, at a minimum, shall agree to the individual's competence.
7.9.2.b. If the individual is determined to be able to make an informed decision relative to treatment, the proposed treatment shall be explained in detail and written consent to treatment shall be requested. Individuals shall be asked to sign consent to treatment unless the individual has been determined to lack capacity. Treatment may be initiated if the individual gives consent, but a refusal to consent shall be honored and no treatment shall thereafter be forced upon the individual prior to receiving a written commitment order from the circuit court pursuant to a commitment hearing.
7.9.2.c. If it is determined that the individual is not capable of giving informed consent to treatment, the physician shall determine whether there is a significant likelihood that the symptoms for which the treatment is proposed are likely to become either more severe or long-lasting or both if treatment is withheld, and whether the proposed treatment is likely to produce side effects which may be harmful to the individual. Proposed treatments shall be those which are commonly accepted and recognized as appropriate for the condition being treated. In every instance, the more conservative of the available treatment options shall be chosen.
7.9.2.d. If the physician determines that there is risk of serious deterioration in the absence of treatment and that the proposed treatment carries relatively little risk to the patient, the physician shall present to the clinical/medical director the facts upon which these conclusions were based.
7.9.2.e. If the clinical/medical director agrees with the recommendations, an independent evaluation by another physician qualified in psychiatry or other appropriate medical specialty shall be provided.
7.9.2.f. All steps in this procedure, as well as all the facts on which treatment decisions are based, shall be documented in the medical record, and signed by the attending physician consistent with the applicable standard of care.
The procedures outlined in this section are not intended to apply to those individuals who are in need of life-saving medication for chronic medical conditions (such as diabetes, heart disease), who have been taking the medications prior to admission, and who are not actively refusing to continue the medication, notwithstanding that they may not currently be able to give consent.
7.10. Informed Consent. Consent is not valid unless it is informed consent. To ensure informed consent, the admitting physician shall explain and discuss the following with each patient:
7.10.1. The nature of the patient’s mental condition;
7.10.2. The reasons for taking any proposed medication, including the likelihood of the patient’s condition improving or not improving without the proposed medication;
7.10.3. That consent, once given, may be withdrawn at any time by stating the intention to any member of the treating staff;
7.10.4. The reasonable alternative treatments available, if any;
7.10.5. The type, range of frequency and amount, including the use of PRN (as needed) orders, the method (oral or injection) of administration, and the duration of taking the proposed medication;
7.10.6. The probable side effects to the proposed medication known to occur commonly, and any particular side effects likely to occur with the particular patient;
7.10.7. Possible additional side effects of the proposed medications which may occur to patients taking the medication beyond three months. The patient shall be advised that the side effects may include persistent involuntary movement of the face or mouth and might at times include similar movement of the hands and feet, and that these symptoms of tardive dyskinesia are potentially irreversible and may appear after medication has been discontinued; and
7.10.8. His or her rights under this rule.
7.10.9. This explanation and discussion shall be documented and signed by physician and patient.
7.11. Requirement for Consent. Antipsychotic medication may be administered to an adult patient only after the patient has given informed, voluntary consent in writing, except as provided in the procedures set forth in this subsection or as required by the applicable standard of care.
7.11.1. Consent shall be considered to be informed only after the patient has been provided with the information specified in subsection 7.10 of this rule by the physician prescribing the medication.
7.11.2. The patient shall be asked to sign the consent form utilized in obtaining informed consent from voluntary patients, and this signed consent form shall be included in the legal section of his or her chart. In the event that the patient has been shown the form and communicates consent but does not wish to sign the written consent form, it is sufficient for the physician to place the unsigned form in the patient’s record together with the notation that while the patient understands the nature and effect of antipsychotic medication and consents to the administration of the medication, the patient does not want to sign a written consent form.
7.11.3. Consent is effective for the duration of the patient’s stay in the facility unless it is revoked by the patient.
7.12. Revocation of Consent. A patient who has consented to medication may refuse a specific medication at any time, by stating or writing that he or she does not wish to take the medication. Medication may not then be given to the patient, orally or by injection, except as authorized in a psychiatric emergency, or as determined as appropriate under section 8.5, et seq below and documented in the patient’s record. A revocation of consent shall be documented on the consent form by the treating physician and renders the previously given consent void.
W. Va. Code R. § 64-59-8 Right to Refuse Treatment
8.1. General. As a participant in the program planning process, the patient has the right to exercise a voice in his or her program plan and to object to or refuse aspects of the plan.
8.2. Use of Internal Discussion, Negotiation and Grievance Procedure. The patient’s right to object to or refuse treatment is recognized as legitimate and shall be responded to in accordance with the provisions of the patient grievance procedure if informal discussion and negotiation do not resolve differences.
8.3. Alternatives Offered and Provided. The treatment team for any patient who has refused psychotropic medications or other recommended therapy shall meet and work to ensure that an agreed-upon effective alternative treatment is offered and provided if the patient consents.
8.4. Oral Refusal Overrides Prior Written Consent. An individual patient’s oral refusal to accept medication or other treatment always overrides prior written consent except in emergency situations as defined in this rule or as required by the applicable standard of care.
8.5. Last Resort Procedure When Patient Refuses Treatment. In those instances when an involuntarily committed patient rejects any proposed treatment and all attempts at negotiating an acceptable alternative have failed, then the most conservative, least intrusive treatment approach that is acceptable under the applicable standard of care for the diagnosed condition and which produces minimal potential side effects may be imposed over the objections of the patient if all the following conditions are documented in the patient’s medical record:
8.5.1. The patient’s refusal is a product of his or her illness;
8.5.2. The proposed treatment is recognized as appropriate, effective and within accepted standards of practice;
8.5.3. The proposed treatment is approved by the clinical/medical director;
8.5.4. The opinion of a second qualified practitioner concurs with the proposed treatment; and
8.5.5. The patient advocate is provided an opportunity to raise legitimate concerns on the part of the patient.
W. Va. Code R. § 64-59-9 Research and Experimental Treatment
All research, studies, and investigations conducted in mental health facilities to which this rule is applicable, which use facility staff, records or patients shall be approved in writing in advance by the Department of Health Facilities and the Institutional Review Board. This advance approval is required whether the research, study or investigation is conducted by Department of Health Facilities staff or by others. The federal regulations Protection of Human Subjects, 45 C.F.R. Part 46, are hereby adopted by reference, and all research, studies, or investigations conducted in mental health facilities shall comply with this rule.
W. Va. Code R. § 64-59-10 Seclusion and Restraints
10.1. General. Patients have the right to freedom from seclusion or mechanical restraints unless otherwise clinically indicated and consistent with the applicable standard of care as provided herein. Seclusion and restraint shall only be used when there is imminent danger that the patient will injure himself or herself or others and when all other less restrictive measures have been exhausted or no less restrictive measures are reasonably available. Seclusion or mechanical restraints that are used solely as a means of coercion, discipline, convenience, or retaliation are prohibited.
The use of restraint or seclusion shall only be administered in accordance with the order of a physician or psychiatrist or, in their absence, an advanced nurse practitioner or physician’s assistant responsible for the care of the patient. A registered nurse who is trained in crisis intervention may initiate the emergency application of restraint or seclusion prior to obtaining such an order: Provided, That the emergency application of restraints or seclusion requires that the registered nurse obtain an order forthwith after the restraint or seclusion has been applied. Under no circumstance may orders for the use of restraint or seclusion ever be written or provided as a standing order or on an as needed basis.
10.2. Seclusion and Restraint. Seclusion of any patient or mechanical restraints for any patient, or both, may be administered only as expressly permitted by 42 C.F.R. § 482.13(e). The use, time period for use, and documentation of the use of seclusion or mechanical restraints, or both, in the patient’s medical record shall be done in accordance with 42 C.F.R. § 482 and the State Operations Manual: Provided, That seclusion or mechanical restraints for developmentally disabled patients are prohibited and only the “time out” procedure developed specifically for each such patient in his or treatment plan and in accordance with applicable law may be used for a developmentally disabled patient.
All personnel at a mental health facility who administer or assist in the administration of seclusion or the use of mechanical restraints shall undergo training as required by 42 C.F.R. § 482.13(f) and shall further complete subsequent periodic training no less frequently than annually regarding the use of seclusion and or mechanical restraints.
10.3. Time. The time spent in seclusion shall be the shortest time required for the patient to regain his or her self-control.
10.4. Seclusion Inappropriate for Suicidal Patients. Seclusion shall not be used for a patient who is actively suicidal or for a patient for whom constant observation has been ordered. If the physician determines that seclusion is necessary, the need for such seclusion shall be documented in the patient’s medical record and one-on-one observation of the patient shall be required.
10.5. Items Entitled During Seclusion. A patient who is placed in seclusion is entitled to clothing, a bed, a mattress, bedding, reading matter, stationery, and similar items. Only when it is determined that a specific item may be harmful to the patient may the item be withheld. The order for seclusion shall specify those items which are to be removed and the reasons for their removal.
10.6. Supervision of Seclusion Room. Any room used for seclusion shall be in an area that permits constant supervision by staff by direct observation, video observation, or both.
10.7. Seclusion Room Supervision. The registered nurse in charge of the unit or shift is responsible for assuring that the following seclusion room checks, and procedures are carried out:
10.7.1. Each patient in seclusion shall be checked no less frequently than every five minutes and as required by 42 C.F.R. § 482.13. The seclusion room "check sheet" shall be updated to assure the presence and safety of the patient in the seclusion room;
10.7.2. The patient shall have access to fluids and to the toilet hourly. Meals shall be delivered at regular meal times. Compliance with these requirements shall be documented on the check sheet; and
10.7.3. The case manager, when available, or the registered nurse in charge of the unit or shift shall talk directly with the secluded patient and assess the need for continued seclusion at least once every hour.
10.8. Supervision of Mechanical Restraints. Supervision of patients in mechanical restraints shall be on a one-to-one basis for the duration of the time the restraints are in place. The procedure for the application of mechanical restraints shall be followed to assure that no restraint is applied in a manner as to produce physical pain or damage to the patient. Opportunity for motion and exercise shall be provided for a period of not less than 10 minutes during each two hours in which restraint is employed.
10.9. Handcuffs Unacceptable. Handcuffs are not considered an acceptable form of restraint for patients and shall not be used for that purpose.
10.10. Continued Hourly Assessment. The case manager, when available, or the registered nurse in charge of the unit or shift shall talk directly with the restrained patient and assess the need for continued restraint at least once every hour.
10.11. Punishment or Convenience. Mechanical Restraints shall not be used as punishment or for the convenience of staff.
10.12. Limitation on Use of Chemical Restraint. Drugs or medications shall not be used as punishment, for the convenience of staff, as a substitute for adequate staffing, or as a substitute for a treatment plan. Drugs and medication may only be administered pursuant to informed consent in the absence of a psychiatric emergency or pursuant to 8.5, et seq of this rule.
10.13. Copies. All documentation related to the seclusion or restraint of a patient shall be done in accordance with the applicable standard of care, 42 C.F.R. § 482.13, and the State Operations Manual.
10.14. Trial Release Procedure for Seclusion and Restraint. Seclusion and restraint are intended to provide external controls for the protection of the patient or to prevent the patient from injuring others. Continued use of the controls beyond the time when they are clinically indicated is inappropriate. It is the responsibility of the nurse on duty to assure that the seclusion or restraint measures are stopped when the behavior of the patient makes their continued use unnecessary and to further inform the ordering physician promptly of events that support the cessation of seclusion or restraints.
W. Va. Code R. § 64-59-11 Confidentiality and Records
11.1. Confidential Information
11.1.1. Communications and information obtained in the course of treatment or evaluation of any patient is considered to be confidential information in accordance with 42 C.F.R. § 482.13, including: the fact that a person is or has been a patient; information transmitted by a patient or his or her family for purposes relating to diagnosis or treatment; information transmitted by persons participating in the accomplishment of the objectives of diagnosis or treatment; all diagnoses or opinions formed regarding a patient’s physical, mental or emotional condition; any advice, instructions or prescriptions issued in the course of diagnosis or treatment; and any record or characterization of these matters. Confidential information does not include information which does not identify a patient, information from which a person acquainted with a patient would not recognize the patient, and encoded information from which there is no possible means to identify a patient.
11.1.2. In order to protect the patient from demeaning remarks about his or her condition, medical and behavioral health care professionals, staff and other employees shall not discuss a patient’s assessment, diagnosis, treatment, or any other aspects of his or her condition among themselves unless this discussion directly relates to the patient’s treatment.
11.2. Disclosure of Confidential Information
11.2.1. Confidential information may be disclosed:
11.2.1.a. In a proceeding under W. Va. Code §27-5-4 to disclose the results of an involuntary examination made pursuant to W. Va. Code §27-5-2 or §27-5-3;
11.2.1.b. In a proceeding under W. Va. Code §27-6A-1 et seq. to disclose the results of an involuntary examination made pursuant thereto;
11.2.1.c. Pursuant to an order of any court based upon a finding that the information is sufficiently relevant to a proceeding before the court to outweigh the importance of maintaining the confidentiality established by this section. Once a subpoena is received it is the duty of the custodian of the records to request a determination from the court having jurisdiction to make this finding before the records are provided;
11.2.1.d. To protect against a clear and substantial danger of imminent injury by a patient to himself or herself another; and
11.2.1.e. For treatment or internal review purposes, to staff of the mental health facility where the patient is being cared for or to other health professionals involved in treatment of the patient.
11.2.2. Patients shall be informed upon the commencement of any contact with medical or behavioral health professionals that their rights to confidentiality are limited in the ways set forth in this rule.
11.3. Authorization for Disclosure
11.3.1. All consents for the transmission or disclosure of confidential information shall be in writing and signed by the patient or by his or her legal guardian as required by applicable law. Every person signing an authorization shall be given a copy.
11.3.2. Every person requesting an authorization shall inform the patient or authorized representative that refusal to give an authorization will in no way jeopardize his or her right to obtain present or future treatment except where and to the extent disclosure is necessary for treatment of the patient or for the substantiation of a claim for payment from a person other than the patient.
11.4. Clinical Records
11.4.1. A clinical record shall be maintained at a mental health facility for each patient treated by the facility. The record shall contain all matters relating to the admission, legal status, treatment of the patient and all pertinent documents relating to the patient, including detailed results of: (1) periodic examinations; (2) individualized treatment programs, including the written, dated, individualized plan of care stating the specific outcome of treatment goals and the progress made towards realizing those goals, and dated notations of any change of outcome, treatment goals or plan of care; (3) evaluations and re-evaluations; (4) orders for treatment; and (5) orders for application of mechanical or chemical restraints or seclusion.
11.4.2. Records. A facility shall maintain a written patient record on each patient, which shall include the following:
11.4.2.a. All information contained in the pre-admission data package, the post-admission data base, and the discharge records, plus the patient’s sex, race, ethnic origin, next of kin, and type and place of employment;
11.4.2.b. A description of the patient’s physical and mental status at the time of admission, a record of each physical examination, psychological report, or any other evaluations, including all those required by this rule, reports of laboratory, roentgenographic, or other diagnostic procedures, and reports of medical and surgical services when performed;
11.4.2.c. Physical and emotional diagnoses that have been made using a recognized diagnostic system;
11.4.2.d. A copy of the patient’s individualized treatment plan and any modifications and evaluations of the plan, with an appropriate summary to guide direct care staff in implementing the plan;
11.4.2.e. The findings made in periodic review of the patient’s response to his or her individualized treatment plan, with directions as to modifications, prepared by a professional involved in the patient’s treatment program;
11.4.2.f. A copy of the post-institutionalization plan and any modifications to the plan, a summary of the steps that have been taken to implement that plan, and all social service reports;
11.4.2.g. A medication history and status, as required by this rule;
11.4.2.h. A signed order by authorized personnel for every occasion on which seclusion, mechanical restraints, or chemical restraints were used;
11.4.2.i. A description of any extraordinary incident or accident involving the patient, to be entered by a staff member noting personal knowledge of the incident or accident or other source of information, including all reports of investigations of mistreatment, as required by this rule;
11.4.2.j. Documentation of the consent of the patient or an appropriate legal representative for admission or treatment;
11.4.2.k. Correspondence concerning the patient’s treatment signed and dated;
11.4.2.l. Documentation of the patient’s and, as appropriate, family members' involvement in the patient’s individualized treatment plan;
11.4.2.m. A summary of the extent and nature of any work activities and the effect of the activity upon the patient’s progress;
11.4.2.n. A discharge summary, which shall be entered in the patient’s record within a reasonable period of time, not to exceed 30 days, following discharge; and
11.4.2.o. A plan for aftercare.
11.4.3. If for any reason a patient’s rights are restricted as permitted within this rule, the restriction, the time limits of the restriction, the reason for the restriction and any other information relevant for the restriction shall be made a part of the patient’s fiscal or clinical record, as applicable. The entry of the restriction in the record shall be signed by the patient’s treating physician.
11.4.4. Each patient’s records shall be readily accessible to all professional staff. Appropriate records shall be maintained on a unit, and direct care staff involved with a particular patient shall have access to those portions of a patient’s records relevant to treatment.
11.4.5. The Health Information Management Department (Medical Records) shall maintain, control, and supervise the patient records, and is responsible for maintaining their quality in accordance with 42 C.F.R. § 482.24 and the State Operations Manual.
11.5. Disclosure of Records.
11.5.1. Records shall only be disclosed:
11.5.1.a. Upon written consent of the patient pursuant to subsection 11.3 of this rule to any person or entity;
11.5.1.b. Upon the grounds set forth in subsection 11.2 of this rule;
11.5.1.c. To the attorney of the patient whether in conjunction with pending proceedings. In the interests of economy, the patient’s attorney may be requested, but not required, to review the record to determine what portions of the record he or she wishes to have copied. If the attorney does not agree to the request, however, the entire record shall be provided. The facility is entitled to charge for the actual cost of copying any voluminous documents required where the patient has funds to pay;
11.5.1.d. To providers of health, social, or welfare services involved in caring for or rehabilitating the patient. The information shall be kept confidential and used solely for the benefit of the patient. No written consent is necessary for employees of the department, comprehensive behavioral health centers serving the patient, or advocates under contract with the department; or
11.5.1.e. With the consent of the patient or a person authorized to act for the patient, and the consent of the Secretary of the Department of Health Facilities, to:
11.5.1.e.1. Persons or agencies that require the information in order to provide continuing service to the patient; and
11.5.1.e.2. Insurers or other third-party payers, only information as is necessary to permit payment.
11.5.2. There is an obligation on the part of the facility staff to assure that a patient is provided access to the record in a clinically responsible manner. For those patients currently in treatment who ask to see records, a qualified clinical staff member should review the record with the patient providing interpretation and clarification as may be needed to assure that the patient has an accurate understanding of the content. Copies of any part of the record may be provided to the patient if requested and if, in the judgment of the interdisciplinary team and the physician, it would not be clinically inadvisable. Any discussion with the patient regarding the clinical record shall be documented in the record. When a former patient demands access to records, the same process shall be followed as described in this subdivision. If the request is made by mail and the patient indicates an inability to visit the facility for records review, arrangements shall be made through the behavioral health center serving the county of the patient’s residence for review of the record with a clinical staff member of the behavioral health center, following the process outlined in this subsection.
W. Va. Code R. § 64-59-12 Right to Unrestricted Communication
12.1. Generally. Every patient has the right to unimpeded and private communication with whomever the patient chooses by mail, telephone, visits, or otherwise, except as specified in this rule.
12.2. Written Correspondence.
12.2.1. Every patient is entitled to communicate by sealed mail, or otherwise, with any persons, including official agencies inside, or outside, the facility. This right may not be denied, restricted, or infringed in any manner, except as specified in subsection 12.4 of this rule.
12.2.2. The mental health facility shall provide a return address to patients that does not identify the institution. Unless the patient requests that the return address be withheld, it is the responsibility of the mental health facility to ensure that the name and return address are inscribed legibly on all outgoing patient mail without identification of the institutional nature of the facility.
12.2.3. Written correspondence shall not be opened or read by staff. Mail returned by recipients to a patient marked "REFUSED" shall be returned, unopened, to the patient.
12.2.4. Indigent patients shall be provided letter writing materials, including stamps.
12.2.5. There shall be no delay in transmission of outgoing or incoming mail.
12.3. Telephone.
12.3.1. Patients shall have the unimpeded and uncensored right to access to a telephone for the purpose of calling whomever they wish, except as specified in subsection 12.4 of this rule or as otherwise clinically contraindicated. If it is necessary for a patient to be accompanied to the telephone by a staff member, or the assistance of a staff member is needed in making a call, the necessary arrangements shall be made by the staff and the confidentiality of the patient’s conversation shall be fully protected by the staff member assisting the patient.
12.3.2. Patients shall have reasonable access to a telephone for calls on the patient’s unit. Phones shall be available for patients to receive regular incoming calls.
12.3.3. Phone areas shall afford reasonable privacy and comfort.
12.4. Restrictions. Any deviation from the telephone and mail rights afforded by subsections 12.2 and 12.3 of this rule can only be authorized by the interdisciplinary team or the physician for a time specified by the team or as otherwise clinically indicated. A complete report relative to the restriction of telephone or mail rights and the reasons therefor shall be made a part of the patient’s medical record, signed and dated by the patient’s attending physician, and reflected in the patient’s nursing care plan. Restrictions of mail and telephone rights shall expire in three days unless reviewed.
12.5. Visitors.
12.5.1. Every patient has the unimpeded right to refuse or receive (during all reasonable hours) visitors as permitted by 42 C.F.R. § 482.13(h), except as specified in subdivision 12.5.2 of this rule or as otherwise clinically contraindicated. Visitation shall accommodate the working schedules of visitors. The mental health facility shall provide privacy for these visits. Visitors may take patients off grounds as approved by the patient’s treatment team.
12.5.2. The right to visitation can only be limited by the treatment team, for critical clinical reasons. A complete report relative to the restriction of visitation rights and the reasons for the restriction shall be made a part of the patient’s medical record, signed and dated by the patient’s attending physician, and reflected in the patient’s nursing care plan. The restriction expires in three days unless reviewed.
12.5.3. All visits shall be contact visits and facilities shall be provided for privacy with no monitoring of conversations.
W. Va. Code R. § 64-59-13 Personal Clothing and Possessions
13.1. Every patient is entitled to possess and wear his or her own personal clothing, dentures, eyeglasses, hearing aid, and orthopedic appliances, unless the treatment team determines that said appliance or item poses a safety risk or is otherwise deemed inappropriate for the care setting.
13.2. Every patient is entitled to constant access to personal possessions such as diaries, Bibles, or other books, not withheld for safekeeping by the mental health facility or the patient’s family.
13.3. The patient’s attending physician or behavioral health care professional shall justify, in writing in the patient’s medical or behavioral health care record the withholding of personal clothing, or other possessions such as those listed in subsections 13.1 and 13.2 of this rule. The statement shall be dated, signed, and reviewed monthly, showing dates and signatures of the reviews, and shall show that possession of the personal effects would be harmful to the patient or others.
W. Va. Code R. § 64-59-14 Outdoor Exercise and Other Recreational Programming
14.1. Outdoor Exercise. Every patient in an inpatient or residential facility has the right to the opportunity for a minimum of one hour of outdoor access and exercise on a daily basis seven days per week except as otherwise clinically contraindicated. This shall be scheduled and afforded at the time during the day when the weather and temperature are most appropriate, depending on the season.
14.2. Outdoor activity and exercise shall be a part of every patient's treatment plan.
14.3. Activity and Recreational Programs
14.3.1. Individual programs shall provide a balance of active and passive activities, as well as opportunities for daily exercise and outdoor activities to the extent that the patient is clinically and medically able to participate.
14.3.2. While individual activities are scheduled to meet specific therapeutic goals, each patient should have an opportunity to participate in social recreation programs of choice.
14.3.3. Social activities should be planned at several levels: (1) small, unit group activities such as games, music and exercises; (2) individual activities such as magazines, puzzles, books and drawing materials; (3) larger off-unit programs such as dances, walks and sports; and (4) community-based activities utilizing existing community resources such as movies, sightseeing, entertainment, sports, bowling, camping, hiking, picnics, etc.
14.4. Community Integration. Unless specifically contraindicated by a patient’s interdisciplinary program plan or physician, each patient, other than acute psychiatric and out-of-contact geriatric patients, shall be provided the opportunity to engage in the following activities as determined by the patient’s treatment team in its clinical discretion and in the patient’s best interests, which may include, but is not limited to the following:
14.4.1. Shop in the community;
14.4.2. Eat in a public place in the community;
14.4.3. Participate in a major recreational activity in the community;
14.4.4. Attend a public event in the community;
14.4.5. Worship in the community on a regular basis; and
14.4.6. Visit the local public library on a regular basis.
14.5. Interdisciplinary Treatment Plan.
14.5.1. Activity staff shall serve as members of each patient’s interdisciplinary team when appropriate. Activity staff are responsible for a recreational and activity assessment for each patient. The recreational and activity assessment shall indicate the level of appropriate recreational and social activities for the patient, the patient’s areas of strengths, and the limitations of the patient. Based on the assessment, the activity staff shall work with the patient and other members of the interdisciplinary team to develop a recreational and activity program that meets the identified needs of each patient. Activity staff shall provide ongoing documentation of the patient’s response to the implementation of the program.
14.5.2. Implementation of community integration as described in subdivision 14.3.3 of this rule and participation in recreational activities as described in subdivision 14.3.2 of this rule shall be documented in each patient’s record.
W. Va. Code R. § 64-59-15 Physical Environment
15.1. Mental Health Facilities Generally
15.1.1. Facilities shall provide an environment that complies with 42 C.F.R. § 482.41 and respects the human dignity of the patients. The grounds of the facilities shall have adequate space for the facility to carry out its stated goals. All facilities shall be accessible to individuals with a disability.
15.1.2. Behavioral health facilities shall provide facilities which afford patients privacy, dignity, comfort, safety, and sanitation.
15.1.3. There shall be appropriate and sufficient lighting in each facility, and whenever possible and consistent with the safety of patients, the lighting shall be controlled by patients.
15.1.4. Whenever possible, the environment shall provide views of the outdoors.
15.1.5. All rooms shall provide adequate ventilation and comfortable temperatures. Direct outside air ventilation shall be provided to each patient’s room unless otherwise contraindicated. Ventilation shall be sufficient to remove all undesirable odors.
15.1.6. Every room shall be kept clean, odorless, and insect free.
15.1.7. Areas with the following characteristics shall be available to meet the needs of patients:
15.1.7.a. Areas that accommodate a full range of social activities, from two person conversations to group activities;
15.1.7.b. Attractively furnished areas with a supply of comfortable chairs adequate to meet patient requests and needs for seating, and areas in which a patient can be alone, when appropriate; and
15.1.7.c. Attractively furnished areas for private conversations with other patients, family, or friends.
15.1.8. Inpatient life shall be structured so that it is possible for patients to wear and use glasses, hearing aids, crutches, braces, rolling walkers, and similar aids in their units and rooms.
15.1.9. The use and location of noise-producing equipment and appliances, such as televisions, radios, and other electronic devices shall not interfere with other therapeutic activities.
15.1.10. A place and equipment shall be provided for table games and individual hobbies. Equipment and games shall be stored on shelves that are accessible to patients as appropriate. An adequate budget for the materials and equipment shall be maintained so that items which are lost, broken, or stolen can be replaced.
15.1.11. Unless contraindicated by the ITP, male and female patients may be housed on the same inpatient units and in a manner that allows interaction and as closely resembles noninstitutional living as possible.
15.1.12. Facilities that routinely serve non-ambulatory patients or medically fragile patients shall also comply with the following requirements:
15.1.12.a. Beds shall be placed so that patients are not exposed to temperatures outside of normal comfort range; and
15.1.12.b. The facility shall establish a program for identifying, investigating, preventing, and controlling infections; monitoring the health status of employees; and providing aseptic procedures and isolation techniques.
15.2. Bedrooms in Inpatient Facilities.
15.2.1. Each facility shall provide furnishings and equipment which are clean and in good condition, and appropriate to the age and physical conditions of the patients. Every patient shall be provided with a normalized, comfortable, and attractive living space.
15.2.2. An individual bed shall be provided for each patient.
15.2.3. No person shall be housed in a bedroom with more than one other person. Sleeping areas shall be assigned based on the patient’s need for group support, privacy, and independence.
15.2.4. All bedrooms shall have outside windows, be above ground level, and provide adequate space for patient privacy.
15.2.5. Ample closet and drawer space shall be provided for storing clothes, personal hygiene articles, and other personal property or property provided for patients’ use.
15.2.6. Bathrooms and bedrooms shall have doors or other barriers suitable to provide privacy.
15.2.7. All mattresses shall be fire and urine resistant and without appreciable sag. All reasonable requests by patients for new mattresses shall be honored.
15.2.8. Blankets with holes or stains shall be cleaned and repaired or replaced.
15.2.9. Patients shall be allowed to keep and display personal belongings and to add personal touches to the decoration of their rooms unless otherwise contraindicated.
15.2.10. Articles for grooming and personal hygiene shall be readily available in a space reserved near the patient’s sleeping area.
15.2.11. Patients shall have ready access to the grounds and to their bedrooms unless contraindicated by their ITP or attending physician.
15.2.12. All windows in bedrooms shall have curtains or blinds and all beds shall have bedspreads.
15.3. Bathrooms, etc. in Inpatient Facilities.
15.3.1. The facility shall have toilets, water fountains, bathing and hand washing facilities which are accessible, private, and easily usable, including special equipment for persons with disabilities. All toilets shall have toilet seats, or be of a construction with an integrated seating surface, and all toilet stalls shall have doors or other barriers to promote privacy.
15.3.2. There shall be easily accessible and adequate toilet paper, bath towels, soap, linen, bedding, etc. Clean towels and bed linens shall be provided at least twice weekly.
15.3.3. All sinks, showers, and bathtubs used by patients shall dispense reasonably temperate water and be provided with reasonably temperate water at all times except as required for repair or maintenance. All showers shall have doors or curtains and all bathtubs shall be screened for privacy.
15.4. Other Areas
15.4.1. Bathrooms are to be cleaned as often as necessary every day, and bathtubs shall be cleaned after the bath of each patient. The smell of harsh disinfectants shall be eliminated.
15.4.2. There shall be separate clean and dirty linen storage areas.
15.4.3. Patients’ personal laundry shall be done at least two times per week. Patients’ rooms and common areas shall be thoroughly cleaned at least two times per week.
15.4.4. Living areas shall have comfortable chairs appropriate for patients in numbers sufficient to seat every patient desiring to sit in a chair unless otherwise contraindicated.
15.4.5. Adequate lighting will be provided in every living area.
15.4.6. Clocks and calendars shall be provided in at least major use areas.
15.4.7. Mirrors shall be placed at reasonable heights in appropriate places to aid in patients’ grooming.
15.4.8. Books, magazines, and arts and crafts materials shall be available in accordance with patients’ backgrounds and needs. An adequate library shall be maintained at each facility.
15.4.9. Living, program, and working areas shall be quiet, appropriately designed, and conducive to programs. Acoustical ceiling tiles shall be installed wherever noise levels remain high.
W. Va. Code R. § 64-59-16 Food
16.1. Meals Generally. Food and dietetic services shall comply with 42 C.F.R. §§ 482.28, 482.41, and 482.42; the State Operations Manual; and the FDA Food Code.
W. Va. Code R. § 64-59-17 Patients’ Labor, Earnings and Funds
17.1. Patient Labor Generally
17.1.1. No patient may be required to perform labor which involves the operation and maintenance of the mental health facility. Privileges or release from the facility shall not be conditional upon the performance of labor governed by this rule.
17.1.2. Patients may voluntarily engage in labor which involves the operation and maintenance of the mental health facility if the labor is compensated in accordance with the requirements of relevant state and federal law and regulations.
17.1.2.a. Patients who are employed to perform work of economic benefit to the facility shall be paid wages which are commensurate with those paid workers with no disability for essentially the same type, quality, and quantity of work.
17.1.2.b. The facility shall maintain for each patient who is employed by the facility, and have available for inspection, records of: the prevailing wages paid workers with no disability in similar jobs; production standards for average workers with no disability performing similar jobs; and the productivity of each patient. These records shall be reviewed at least quarterly.
17.1.2.c. Patients may not be regularly involved in the care, feeding, clothing, training, or supervision of other patients.
17.2. Vocational Training. Patients may be required to perform vocational training tasks which do not involve the operation and maintenance of the facility, so long as an assignment:
17.2.1. Lasts no longer than four months;
17.2.2. Is an integrated part of the patient’s interdisciplinary program plan;
17.2.3. Has been approved as a program activity by the professional responsible for the vocational training program;
17.2.4. Is supervised by a staff member.
17.3. Personal Housekeeping. Patients may be required to perform personal housekeeping tasks, such as making their bed, tidying their room, doing their laundry, etc.
17.4. Work Training or Industrial Therapy Program.
17.4.1. Before a patient begins any work training or industrial therapy program, there shall be a written plan outlining goals, activities, and job responsibilities within the program.
17.4.1.a. Work Activity Center. The entire facility, or any part thereof, may be designated a work activities center if no patient participating in work activities is capable of more than 25 percent of the productivity of workers with no disability performing the same or comparable type work. Every patient involved in the program shall be evaluated in terms of his or her level of productivity, and the evaluation shall be reviewed and documented no less than every three months. An exception may be made when an individual patient is unable to meet the productivity level of the rest of the group. For these patients, minimum wages below those paid to other workers may be permitted.
17.4.1.b. Sheltered Workshops. Approval for a sheltered workshop may be obtained for a specific workshop program. Sheltered workshops operated by a facility are required to be in compliance with applicable state and federal laws, rules, and regulations.
17.4.1.c. Training and Evaluation Program. A certificate can be obtained for programs which provide competent instruction and supervision and are designed to determine a working patient’s potential and to teach adjustment to a work environment or the skills related to one or more types of work. The duration of the evaluation and training shall depend upon the total facts of the situation, but in no case shall exceed 12 months. Time spent in an employment relationship in the institution, prior to the effective date of participation in the training program shall be counted in determining the duration of the work evaluation and training. It is not permissible to place a patient who has been involved in any work situation within the facility for more than 12 months in a work and training evaluation program without pay.
17.5. Access to Personal Funds.
17.5.1. There shall be procedures, in writing, to ensure a patient’s reasonable access to his or her personal funds.
17.5.2. Patients not adjudicated incompetent shall have access to their funds whenever and in any amount they wish unless their use of funds proves detrimental to their course of treatment. In these cases, the patient’s treatment team shall document in the patient’s medical record the withholding of funds for a limited period of time.
17.5.3. Patients adjudicated incompetent and appointed a conservator or other with financial authority shall have the same access to their funds as set forth in subdivision 17.5.2 of this rule, subject to reasonable limitations by their conservator. In these cases, the patient’s medical record shall document the withholding of the patient’s funds or the limitations set for the patient’s access to his or her funds.
17.5.4. A patient or relative may be required to pay for care and treatment in a mental health facility according to the ability to pay; however, no patient shall be denied treatment because they are not able to pay.
17.6. Notification. All patients assigned to a work situation shall be informed of the rights provided by this rule. The information shall be provided as follows:
17.6.1. The patient workers and their responsible relative or legal representative may be notified in writing of these rights;
17.6.2. Written notification of rights under this rule shall be posted in every living unit; and
17.6.3. Efforts shall be made to notify all patients orally by group meeting or other direct oral notice.
W. Va. Code R. § 64-59-18 Employee Responsibilities
18.1. Duty of All Employees. Every employee has the responsibility to ensure that all rights afforded to patients by applicable state and federal laws, rules, and regulations, including this rule, are protected and afforded to patients.
18.2. Abuse and Neglect. No employee shall verbally or physically abuse or neglect any patient.
18.3. Sexual Harassment. Employees shall not engage in sexual harassment of patients.
18.4. Mandatory reporting. Every employee has a duty to report any incident of actual or suspected abuse or neglect to the administrator and to adult protective services workers.
18.5. Training of Employees. The administrator has the duty to train and educate all new employees and all current employees on a periodic and consistent basis on the content of this rule so that all employees are thoroughly familiar with it.
18.6. Staff shall be aware of W. Va. Code §27-12-3 which reads as follows: "If any person shall entice any patient from any state hospital who has been legally committed thereto, or attempt to do so; or shall counsel, cause, influence or assist, or attempt to do so, any such patient to escape or attempt to escape therefrom or harbor or conceal any such patient who has escaped therefrom; or shall, without the permission of the superintendent of any such hospital, give or sell to any such patient, whether on the premises thereof or elsewhere, any money, firearms, drugs, cigarettes, tobacco, or any other article whatsoever; or shall receive from the hands of any such patient anything of value, whether belonging to the state or not; or shall cause or influence or attempt to cause or influence any such patient to violate any rule or to rebel against the government or discipline of such hospital; or shall tease, pester, annoy, or molest any such patient, he shall be guilty of a misdemeanor, and, on conviction thereof, shall be fined not less than $10 nor more than $100, or imprisoned not exceeding six months, or, in the discretion of the court, both fined and imprisoned. If any person shall aid or abet the commission of any of the foregoing offenses, or aid or abet an attempt to commit the same, he shall be guilty of the same as if he were the principal, and be punished as above provided. In the trial of an indictment for committing any of the above-named offenses, the accused may be found guilty of an attempt to commit the same, or of aiding or abetting another in committing or in an attempt to commit the same. If any person, not her husband, shall have sexual intercourse with any female patient who is a patient of any of said state hospitals, he shall be guilty of a felony, and, on conviction thereof, shall be confined in the penitentiary not less than 10 nor more than 15 years; and if such female patient be under 16 years of age, he shall be imprisoned not less than 10 nor more than 20 years."
W. Va. Code R. § 64-59-19 Juveniles
No person under 18 years of age shall be admitted to a mental health facility as defined herein.
W. Va. Code R. § 64-59-20 Patient Advocacy and Grievance Procedure
20.1. Patient Advocacy. There shall be persons designated as patient or resident advocates who are independent of the facility management in every mental health facility.
20.2. Right to File A Grievance. A grievance may be initiated by a patient or patient advocate, a member of a patient’s family, a facility employee or other individual on behalf of any patient of a mental health facility: Provided, That the patient advocate must comply with 42 C.F.R. § 482.13(a)(2) for filing a grievance and the prompt resolution of grievances. A grievance may involve any aspect of a patient’s care, treatment, housing, services, accommodations, etc. and is not restricted to alleged violations of a patient’s rights or abuse of the patient.
20.2.1. Filing of A Grievance. A grievance may be registered by a patient or someone on behalf of the patient, orally or in writing, to any facility staff member or to the patient advocate.
20.2.2. Oral Grievance. When a grievance is orally registered by a patient to a staff member or a patient advocate, the staff member or the patient advocate shall promptly assist the patient in reducing the grievance to writing on the standard grievance form.
20.2.3. A supply of grievance forms shall always be maintained in the administrative offices and on all units or offices of the facility for continuous access by patients. Each facility shall make patients aware of their rights and ensure access to this grievance procedure.
20.2.4. Filing the Grievance. All grievances shall be reduced to writing as specified in subdivision 20.2.2 of this rule and promptly delivered by the staff to the facility administrator or the administrator's designee and the patient advocate.
20.2.5. Response of The Administrator. The administrator or his or her designee, after reviewing the grievance, shall respond to the complaining party by the next work day following receipt of the grievance, unless the grievance involves abuse or neglect, in which case the grievance shall be referred to a patient advocate for investigation within one hour of receipt by the administrator or his or her designee if the advocate was not involved in the preparation of the abuse or neglect grievance. In that case, the grievance shall be answered the next work day following receipt of the report of the patient advocate.
20.2.6. The response by the administrator or his or her designee shall be in writing on the grievance form and a copy of the response shall be delivered to the complainant and the patient advocate. The hospital is responsible for keeping an accurate record of all grievances, of actions taken, and their resolution.
20.2.7. The facility shall seek to resolve grievances as expeditiously as possible either by providing the relief requested or utilizing internal administrative mechanisms, treatment teams, etc. Living units operated by the facility shall have mechanisms in place to facilitate communication and resolution of problems such as environmental problems and interpersonal conflicts experienced by patients.
20.2.8. Action on Grievances. The administrator shall promptly initiate appropriate action to correct meritorious grievances.
20.2.9. Abuse/Neglect Investigation. All grievances of abuse or neglect, or both, shall be investigated by the facility patient advocate or an outside advocate as appropriate. Upon receipt of an abuse/neglect grievance, the advocate shall immediately interview the patient and review the situation. Within the next eight regular working hours, the advocate shall make a written report to the facility administrator. As part of the investigative process the advocate shall have access to all staff members, pertinent records and documents and shall interview witnesses and take statements as appropriate. The advocate shall not have access to employee personnel records; all investigations shall be based on evidence related to the grievance under investigation only.
20.2.10. Reporting Abuse or Neglect, or both. W. Va. Code §9-6-9, the West Virginia Adult Protective Services Act, requires that any and all behavioral health professionals shall immediately report all actual or suspected cases of abuse or neglect of incapacitated adults to the Department of Human Services local adult protective services office. If the report is made by telephone, adult protective services requires a written report from the individual reporting the incident within 48 hours.
20.2.11. When a facility employee or the patient advocate becomes aware or is notified of a grievance of abuse or neglect, he or she shall immediately notify the advocate, the local adult protective services agency directly or by phone, his or her supervisor, and the administrator, and document the incident. Initiation of this procedure in no way abrogates the duty of the facility to respond to the grievance filed in the manner set forth in this rule.
20.2.12. Initiating an Appeal of a Grievance Determination. In the event that the complaining party is not satisfied with the determination by the administrator, the complaining party may appeal the determination by submitting a copy of the original grievance form and determination to the Office of the Mental Health Ombudsman.
20.2.13. No Waiver. Nothing in this rule is intended to serve as a precondition to or supplant any other remedial initiatives that a patient may wish to pursue relative to a claim. Nothing in this rule nor any action by the administrator interferes with or supplants a state employee's rights pursuant to W. Va. Code §6C-2-1 et seq., or application of the grievance procedure for state employees, nor should it be considered to change or waive the employee grievance timelines for filing a grievance.
20.2.14. Confidentiality/Protection. Procedures and investigations conducted under this rule shall be conducted with due regard for the confidentiality, rights, and dignity of all parties. The facility may not discharge or in any manner discriminate against any patient, employee, or other party because of involvement in the grievance or appeal process.
20.2.15. Responsibilities of Parties. The responsibilities of the parties are set forth below:
20.2.15.a. Employees shall be aware of patient rights, know the facility's procedures for reporting and filing grievances, report infractions of patient rights, assist patients to access the facility advocate, to resolve grievances and assist in investigations of infractions of patient rights.
20.2.15.b. Patient advocates shall assist patients in registering and filing grievances, acknowledge grievances, conduct investigations of grievances, notify the administrator of results of grievance investigations, assure that abuse/neglect grievances have been reported to Adult Protective Services, educate staff regarding patient rights and maintain accurate documentation of all grievances and investigations.
20.2.15.c. The administrator and his or her designates shall file responses within established time frames, assure patient protection by appropriate staff disciplinary actions, to deal promptly and effectively with acts of discrimination or reprisal against staff or patients regarding patient rights and supporting staff development efforts toward educating all staff regarding patient rights.
20.2.15.d. Staff Development Officers shall assure that all staff are made aware of patient rights, facility procedures for reporting and resolving grievances, grievance procedures, personnel policies regarding reporting of violations of patient rights, staff grievance procedures and facility policies to protect staff from harassment and retaliation and threats for reporting rights violations.
W. Va. Code R. § 64-59-21 Severability
The provisions of this rule are severable. If any portion of this rule is held invalid, the remaining provisions remain in effect.
64CSR59
Series 61 Public Water Systems Capacity Development
W. Va. Code R. § 64-61-1 General
1.1. Scope. -- This legislative rule establishes state standards and procedures and adopts national safe drinking water standards for capacity development. The 1996 Safe Drinking Water Act amendments require states to ensure that all new community water systems and new nontransient noncommunity water systems demonstrate technical, managerial, and financial capacity to be able to comply with national drinking water regulations. Further, the Safe Drinking Water Act (SDWA) amendments require states to develop a strategy to address the capacity of all public water systems to include:
1.1.a. Determining which public water systems need help and in what order of priority;
1.1.b. Describing enhancers and inhibitors of developing capacity;
1.1.c. Determining a plan of action to help systems in need comply with the SDWA;
1.1.d. Establishing a baseline and measuring program; and
1.1.e. Identifying, in as much as possible, all persons who are interested in or involved with capacity development.
1.2. Authority. -- W. Va. Code ''16-13C-2(b) and 16-1-7.
1.3. Filing Date. -- April 14, 1999.
1.4. Effective Date. -- May 14, 1999.
1.5. Administration. -- This rule is administered by the division of health of the department of health and human resources.
1.6. References.
1.6.a. W. Va. Code '16-1-9a.
1.6.b. West Virginia Division of Health, Public Water Systems, 64CSR3.
1.6.c. West Virginia Division of Health, Drinking Water Treatment Revolving Fund, 64CSR49.
1.6.d. West Virginia Division of Health, Public Water Supply Operator Regulations, 64CSR4.
1.6.e. West Virginia Division of Health, Water Well Regulations, 64CSR19.
1.6.f. West Virginia Division of Health, Water Well Design Standards, 64CSR46.
1.6.g. West Virginia Division of Health, Intended Use Plan for the West Virginia Drinking Water Treatment Revolving Fund.
1.6.h. West Virginia Division of Health, Design Standards for Public Water Supply System, 64CSR42.
1.6.i. West Virginia Division of Health, Mobile Home Parks, 64CSR40.
1.6.j. West Virginia Public Service Commission, Rules and Regulations for the Government of Water Utilities, 150CSR7.
1.6.k. West Virginia Division of Health, Design, Information, and Procedural Manual for Mobile Home Parks, 64CSR41.
W. Va. Code R. § 64-61-2 Application and Enforcement
2.1. Application - This rule applies to all community water systems and nontransient noncommunity water systems as defined in Section 3 of this rule. This rule does not apply to private water wells. This rule does not require consumers serviced by private water wells to abandon their wells nor to connect to any new or existing public water system or community water system as defined in Section 3 of this rule.
2.2. Enforcement - This rule is enforced by the director of the division of health.
W. Va. Code R. § 64-61-3 Definitions
3.1. Capacity -- Capacity refers to a water system=s ability to consistently provide safe drinking water for its customers. A water system must have the technical abilities, managerial skills, and financial resources to meet state and federal drinking water regulations.
3.2. Capacity development -- A program and a tool which helps to ensure all community public water systems and nontransient noncommunity water systems demonstrate the technical, managerial, and financial capacity to comply with Safe Drinking Water Act requirements and to benefit their customers.
3.3. Community water system -- A public water system which serves at least fifteen (15) service connections used by year-round residents or regularly serves at least twenty-five (25) year-round residents.
3.4. Director -- The director of the division of health or his or her designees from the division who are charged with enforcement of this rule.
3.5. Existing public water system -- Any community water system or nontransient noncommunity water system which came into existence prior to October 1, 1999.
3.6. Financial capacity -- The financial resources of the water system, including but not limited to the revenue sufficiency, credit worthiness, and fiscal controls.
3.7. Managerial capacity -- The management structure of the water system, including but not limited to ownership accountability, staffing, organization, and effective external linkages.
3.8. New public water system -- Any community or nontransient noncommunity water system which comes into existence on or after October 1, 1999.
3.9. Noncommunity water system -- Any public water system that is not a community water system.
3.10. Nontransient noncommunity water system -- A public water system that is not a community water system and that regularly serves the same twenty-five (25) or more persons over six (6) months per year.
3.11. Person -- An individual, partnership, association, syndicate, company, firm, trust, corporation, county or municipal government, public or private institution, department, division, bureau, agency, federal agency, or any other entity recognized by law.
3.12. Public water system -- A system which provides water to the public for human consumption through pipes or other constructed conveyances, if the system has at least fifteen (15) service connections or regularly serves at least twenty-five (25) individuals.
3.12.a. Public water system includes:
3.12.a.1. Any collection, treatment, storage, and distribution facilities under the control of the operator of a system and used primarily in connection with the system; and
3.12.a.2. Any collection or pretreatment storage facilities not under the control of the operator of the system which are used primarily in connection with the system.
3.12.b. A public water system does not include a system which meets all of the following conditions:
3.12.b.1. It consists only of distribution and storage facilities and does not have any collection and treatment facilities;
3.12.b.2. It obtains all of its water from, but is not owned or operated by, a public water system which otherwise meets the definition;
3.12.b.3. It does not sell water to any person; and
3.12.b.4. It is not a carrier conveying passengers in interstate commerce.
3.13. Safe Drinking Water Act B A federal statute commonly known as the ASafe Drinking Water Act@ - 42 USC 300f et seq.
3.14. Sanitary Survey -- An on-site review of the water source, facilities, equipment, operation and maintenance of a public water system for the purpose of evaluating the adequacy of the source, design, facilities, equipment, operation and maintenance for producing and distributing drinking water, as described in the federal regulations adopted in this rule.
3.15. Technical capacity -- The physical infrastructure of the water system, including but not limited to the source water adequacy, the infrastructure adequacy (including wells, source water intakes, or both, treatment, storage, and distribution), and the ability of system personnel to implement the requisite technical knowledge.
W. Va. Code R. § 64-61-4 Capacity Development of New Public Water Systems
4.1. A person shall obtain a permit from the director before constructing or awarding a contract to construct a public water system. A person shall obtain approval in writing from the director before establishing a public water system, and the system shall be installed or established in accordance with the plans, specifications and instructions issued by, or approved in writing by, the director.
4.2. A person seeking a permit to construct shall submit to the director an application in accordance with the rule referenced in subdivision 1.6.b. of this rule. The application shall include an engineering report which provides a detailed discussion of the proposed system=s capacity to operate, with an emphasis on financial capacity. The engineer, owner, or both shall provide proof to the director that the owner has the technical, managerial, and financial capacity to operate and maintain the new system. The director shall consult with the public service commission and the water development authority, as well as other affiliated agencies as necessary, concerning the financial and managerial capacity.
4.3. A permit to construct may be revoked by the director for failure of the public water system to comply with this rule.
4.4. The public water system shall be constructed in accordance with the plans and specifications approved by the director in accordance with the rule referenced in subdivision 1.6.h. of this rule.
4.5. The director may issue an order requiring a change in the source of the water supply for the system or in the manner of collection, treatment, storage, or distribution facilities of the system before delivery to the consumer, as may be necessary to safeguard the public health.
4.6. A new public water system shall not commence operation without written approval to proceed from the director.
W. Va. Code R. § 64-61-5 Capacity Development of Existing Public Water Systems
5.1. The director may develop a program for the issuing of a permit to operate a public water system. The director may revoke a permit for failure of the permittee to comply with the requirements of this rule or the requirements of the rule Division of Health, Public Water Systems, 64CSR3. The director shall not issue a permit until he or she has reasonable assurance that the system has achieved or is actively pursuing the technical, managerial, and financial capacity needed to operate in accordance with this rule.
5.2. The capacity of a system shall be assessed using the following indicators:
5.2.a. Compliance data;
5.2.b. Construction permits;
5.2.c. Sanitary surveys;
5.2.d. Annual reports;
5.2.e. Water system plans or business plans;
5.2.f. Compliance reports;
5.2.g. Self-assessment/peer reviews;
5.2.h. Regional plans;
5.2.i. Criteria used by lenders;
5.2.j. Financial viability assessment methods;
5.2.k. Operator certification;
5.2.l. Financial and managerial training;
5.2.m. Permit application data;
5.2.n. Capital improvement plans;
5.2.o. Comprehensive performance evaluation;
5.2.p. Consumer complaint records;
5.2.q. State-wide studies of water quality or quantity;
5.2.r. State revolving fund loan application;
5.2.s. Budgeting worksheets;
5.2.t. Annual financial reports;
5.2.u. Source water assessment programs;
5.2.v. Water conservation plans;
5.2.w. Emergency response plans;
5.2.x. Certificates of convenience and necessity (CCN);
5.2.y. Review of audit reports;
5.2.z. Bond issue reviews;
5.2.aa. Rate reviews and approvals;
5.2.bb. Credit rating services;
5.2.cc. Financial assurance mechanisms;
5.2.dd. Consumer confidence reports; and
5.2.ee. Interviews with personnel familiar with the system.
5.3. A prospective new owner of a public water system shall submit to the director a written application to transfer the permit. The application shall be submitted at least fifteen (15) calendar days before the proposed change of ownership.
5.4. A public water system shall conspicuously post at its treatment plant a copy of the current permit to operate. The original shall be kept on file and available to the director upon request.
W. Va. Code R. § 64-61-6 Inspections and Sanitary Surveys of Public Water Systems
6.1. Public water systems shall be inspected as scheduled by the director, and sanitary surveys shall be conducted by the director.
6.2. Surveys will be performed with in-depth emphasis on capacity development. As a minimum, inspectors shall evaluate the following:
6.2.a. The reliability of the system=s overall infrastructure, including source water protection, treatment, distribution system, and storage;
6.2.b. The treatment process schematic diagrams and determination of the appropriateness of the treatments given the sources used and raw water quality;
6.2.c. The distribution system maps and plan, including operation and maintenance schedules and procedures;
6.2.d. Pump operating condition, including the presence of reserve pumps;
6.2.e. The technical competence of the system operator;
6.2.f. Overall management and operations of the system;
6.2.g. Safety practices; and
6.2.h. Records and record keeping.
W. Va. Code R. § 64-61-7 Penalties
7.1. Penalties are as provided in W. Va. Code '16-1-18. In addition, the director may seek injunctive relief in the circuit court of the county in which all or part of the public water system is situated for threatened or continuing violations.
W. Va. Code R. § 64-61-8 Administrative Due Process
8.1. Those persons adversely affected by the enforcement of this rule desiring a contested case hearing to determine any rights, duties, interests, or privileges shall do so in a manner prescribed in the rule, Division of Health, Rules of Procedure for Contested Case Hearings and Declaratory Rulings, 64CSR1.
The department of health and human resources (DHHR) was created by the Legislature=s reorganization of the executive branch of state government in 1989. The department of health was renamed the division of health and made a part of the DHHR (W. Va. Code ' 5F-1-1 et seq.). Administratively, within the DHHR, the bureau for public health through its commissioner carries out the public health function of the division of health.
64CSR61
Series 63 Asbestos Abatement Licensing Rule
W. Va. Code R. § 64-63-1 General
1.1. Scope. -- This legislative rule establishes procedures and standards for the licensure and training of persons who engage in activities related to asbestos abatement and the operation of asbestos abatement projects; it also identifies the responsibilities of owners of buildings or other man-made structures where asbestos abatement projects are being conducted.
1.2. Authority. -- W. Va. Code '16-32-3.
1.3. Filing Date. -- April 3, 1998.
1.4. Effective Date. -- May 4, 1998.
1.5. Repeal of Former Rule. -- This rule repeals and replaces West Virginia Division of Health Administrative Rules, 64 CSR 63, Asbestos Abatement Licensing Rule, 1990.
1.6. Application. -- This rule applies to: all owners of buildings and other man-made structures; all persons who conduct asbestos abatement projects; all asbestos analytical laboratories; all persons who perform the work of asbestos clearance air monitors, contractors, inspectors, management planners, project designers, supervisors, workers; and all resilient floor covering workers: Provided, That any individual, corporation, partnership, sole proprietorship, firm, enterprise, franchise, association or any business entity which contracts to remove resilient floor covering materials in single-family dwellings is not required to be licensed as an asbestos contractor.
1.7. Enforcement. -- This rule is enforced by the director of the division of health.
W. Va. Code R. § 64-63-2 Definitions
2.1. AIHA. -- American Industrial Hygiene Association.
2.2. Asbestos. -- The asbestiform varieties of chrysotile (serpentine), crocidolite (riebeckite), amosite (cummingtonite-grunerite), anthophyllite, tremolite, and actinolite.
2.3. Asbestos Abatement. -- Procedures to control fiber release from asbestos-containing materials.
2.4. Asbestos Abatement Project . -- An activity involving the repair, removal, enclosure, or encapsulation of asbestos-containing material: Provided, That the removal of less than three (3) square feet or three (3) linear feet of asbestos-containing materials required in the performance of a maintenance activity not intended solely as asbestos abatement is not considered to be an asbestos abatement project.
2.5. Asbestos Abatement Project Designer (or Asbestos Project Designer). -- A person who specifies engineering methods and work practices to be used during asbestos abatement projects.
2.6. Asbestos Abatement Supervisor (or Asbestos Supervisor). -- A person responsible for the direction of asbestos abatement projects.
2.7. Asbestos Analytical Laboratory. -- A facility, company, or place at which asbestos bulk samples or asbestos air samples are analyzed.
2.8. Asbestos Clearance Air Monitor. -- A person who performs air monitoring to confirm clearance levels to establish that an area is safe for reoccupancy after an asbestos abatement project.
2.9. Asbestos-Containing Material. -- Any material or product which contains more than one (1) percent asbestos by weight.
2.10. Asbestos Contractor. -- A person who enters into a contract for an asbestos abatement project.
2.11. Asbestos Inspector. -- A person employed to inspect for the presence of asbestos-containing materials, evaluate the condition of the materials and collect samples for asbestos content confirmation.
2.12. Asbestos Management Planner. -- A person employed to interpret survey results, assess hazards, evaluate and select control options or develop an operation and maintenance plan.
2.13. Asbestos Worker. -- A person who works on an asbestos abatement project.
2.14. Building or Other Man-Made Structure. -- A building or a part of a building, or a group of buildings on the same premises, or any other type of man-made construction, such as a pipe line, barn, shed, trailer, or any appurtenance to a building or other man-made structure.
2.15. Bulk Sample. -- A sample of any material, other than air samples, collected from an existing structure or appurtenance for the purpose of analysis to ascertain whether such material contains asbestos.
2.16. Clearance Air Monitoring. -- Air monitoring performed after the completion of any asbestos abatement project and prior to the reoccupation of the contained work area by the public and conducted for the purpose of protecting the public from health hazards associated with exposure to asbestos fibers.
2.17. Contained Work Area. -- Designated rooms, spaces, or other areas where asbestos abatement activities are being performed, including decontamination structures.
2.18. Director. -- The director of the division of health of the department of health and human resources or his or her designee.
2.19. Division. -- The division of health of the department of health and human resources.
2.20. Encapsulate. -- The application of any material onto any asbestos-containing material to bridge or penetrate the material to prevent fiber release.
2.21. Enclosure. -- The permanent confinement of friable asbestos-containing materials with an airtight barrier in an area not used or designed as an air plenum.
2.22. EPA. -- The United States Environmental Protection Agency.
2.23. Friable. -- Material which is capable of being crumbled, pulverized, or reduced to powder by hand pressure or which under normal use or maintenance emits or can be expected to emit asbestos fibers into the air, including material normally considered non-friable, which has been or may be rendered friable by the forces acting on the material in the course of demolition or renovation operations.
2.24. HEPA (high efficiency particulate air) Filtering System. -- A filtering system capable of trapping and retaining at least ninety-nine and ninety-seven one hundredths percent (99.97%) of all monodispersed particles three tenths (0.3) micrometers in diameter or larger.
2.25. NVLAP. -- National Voluntary Laboratory Accreditation Program.
2.26. OSHA. -- The United States Department of Labor Occupational Safety and Health Administration.
2.27. PCM (phase contrast microscopy). -- A technique used for counting fibers in air samples which does not distinguish fiber types.
2.28. PLM (polarized light microscopy). -- A technique used to identify, quantify, and report asbestos content in bulk samples.
2.29. Person. -- A corporation, partnership, sole proprietorship, firm, enterprise, franchise, association or any individual or entity.
2.30. Reoccupancy. -- Reoccupancy by individuals of a room, space, or other area in which an asbestos abatement project has been completed.
2.31. Repair. -- Returning damaged asbestos-containing material to an undamaged condition so as to prevent asbestos fiber release.
2.32. Resilient Floor Covering. -- Floor tile, sheet vinyl, and associated adhesives which contain more than one (1) percent asbestos by weight.
2.33. Resilient Floor Covering Worker. -- A person who is employed to remove resilient floor covering in single-family dwellings.
2.34. School. -- Any building or man-made structure used for grades kindergarten through twelve (12).
2.35. TEM (transmission electron microscopy). -- A technique which may be used for identifying asbestos structures or fibers in samples.
W. Va. Code R. § 64-63-3 License Required, Procedures, Application, Qualifications
3.1. No person shall perform the work of an asbestos analytical laboratory, clearance air monitor, contractor, inspector, management planner, project designer, supervisor, or worker, or of a resilient floor covering worker without possessing a valid license issued under this rule.
3.2. Individual persons shall be at least eighteen (18) years of age to be licensed under this rule.
3.3. A license expires one (1) year from the last day of the month in which it is issued.
3.4. The director may refuse to issue a license and retain the license fee if the applicant fails to satisfy the requirements of this rule.
3.5. The director may refuse to issue a contractor=s license if he or she finds that the applicant has knowingly falsified or attempted to falsify documents related to an asbestos abatement project or license.
3.6. The director shall provide a written notice of denial and an opportunity for reapplication to all applicants.
3.7. All applicable licensure fees set forth in Table 64-63A found at the end of this rule shall be enclosed with a license application.
3.8. The applicant, or, for a contractor or a laboratory, an authorized agent or officer shall sign the application.
3.9. License applications shall include the following:
3.9.a. A history of all asbestos enforcement actions taken against the applicant by any federal or state agency or court in the two-year period immediately preceding the date of the application;
3.9.b. For an individual person, the applicant's date of birth;
3.9.c. For licensure as a contractor, the number of a current supervisor=s license for the contractor, or the number of a current supervisor=s license for one (1) of the contractor=s employees;
3.9.d. For licensure of an individual person as an asbestos clearance air monitor, inspector, management planner, project designer, supervisor, or worker, or as a resilient floor covering worker, a current certificate of training for the category of license sought;
3.9.e. For licensure of an asbestos analytical laboratory to analyze bulk samples for asbestos, proof of NVLAP accreditation or successful completion of the two (2) most recent rounds of the AIHA bulk asbestos quality assurance program;
3.9.f. For licensure of an asbestos analytical laboratory to analyze air samples for asbestos by PCM, proof of AIHA accreditation or of successful completion of two (2) rounds of the AIHA proficiency analytical testing program (PAT) to analyze air samples;
3.9.g. For licensure of an asbestos analytical laboratory to analyze air samples for asbestos by TEM, proof of accreditation by NVLAP for analysis of air samples by TEM;
3.9.h. For licensure of an asbestos management planner, the number of his or her asbestos inspector's license; and
3.9.i. Any other information relevant to asbestos abatement licensure requested by the director.
3.10. An individual person who is licensed as an asbestos management planner is also required to be licensed as an asbestos inspector.
3.11. A contractor or at least one (1) of the contractor's employees is also required to be licensed as an asbestos supervisor.
W. Va. Code R. § 64-63-4 Licensed Contractor Duties
4.1. Licensed asbestos contractors shall:
4.1.a. Ensure that each of the contractor's employees or agents who will come into contact with asbestos or who will be responsible for an asbestos abatement project is properly licensed;
4.1.b. Ensure that each asbestos abatement project is supervised on-site by a licensed asbestos supervisor;
4.1.c. Not begin an asbestos abatement without written documentation that all the requirements for notification and fees set forth in Section 10 of this rule have been met;
4.1.d. Not participate in an asbestos abatement project not designed by a licensed asbestos project designer;
4.1.e. Ensure that each asbestos abatement project takes place in a contained work area, where required by 29 CFR ' 1926.1101 or, where feasible, as determined by a licensed asbestos project designer;
4.1.f. Ensure that each contained work area is under a negative-pressure, HEPA-filtered exhaust system and meets the minimum clearance standard set forth in Section 6 of this rule before allowing reoccupancy;
4.1.g. Ensure that the asbestos clearance air monitor is provided with an accurate and precise written description of the location of any asbestos abatement project prior to the collection of any air samples;
4.1.h. Ensure that each contained work area is visually inspected prior to the clearance monitoring air to determine whether the asbestos abatement project has been properly completed;
4.1.i. Remove exterior asbestos-containing sidings, cementeous materials, and roofing materials intact with minimal breakage during an asbestos abatement project;
4.1.j. Not construct a mobile contained work area to remove large amounts of asbestos-containing materials to circumvent the minimum clearance standards set forth in this rule;
4.1.k. Use disposal sites which are in conformance with applicable federal, state and local laws, rules, and regulations;
4.1.l. Prepare a record of each asbestos abatement project as required by Sections 4.2 and 4.3 of this rule, and make the record available to the department, the division of environmental protection, and the division of labor of the bureau of commerce upon request; and
4.1.m. Keep the records required by Section 4.1.l of this rule at least thirty (30) years.
4.2. The record of each asbestos abatement project shall include:
4.2.a. The name, address and asbestos license number of all individuals who worked on the asbestos abatement project;
4.2.b. The location and a description of the asbestos abatement project, including the amount of asbestos material that was removed;
4.2.c. The starting and completion dates of each asbestos abatement project and a summary of the procedures that were used to comply with all federal and State standards;
4.2.d. The name and address of each site where waste containing asbestos was deposited, and the disposal site receipts; and
4.2.e. The results of the clearance air monitoring required by this rule for each contained work area within the asbestos abatement project.
4.3. Records of clearance air monitoring results shall include at a minimum the following:
4.3.a. The name and signature of any individual who collected the air samples required by this rule;
4.3.b. The locations where the samples were collected;
4.3.c. The date of collection;
4.3.d. The name and address of the laboratory which analyzed the samples;
4.3.e. The date of the analysis;
4.3.f. The results of the analysis;
4.3.g. The method of analysis;
4.3.h. The name and signature of the individual who performed the analysis; and
4.3.i. Proof that the laboratory meets the applicable requirements of this rule.
4.4. The contractor shall make the records required by this rule available to the director, upon request. Records for current projects shall be immediately available. For completed projects, the director may afford the contractor a reasonable time to comply with the requests, depending upon the length of time since the project's completion and whether or not the advance notice might adversely affect an investigation being conducted by any State agency.
W. Va. Code R. § 64-63-5 Clearance Air Monitor Duties
5.1. Prior to clearing the contained area of an asbestos abatement project for reoccupancy, a clearance air monitor shall:
5.1.a. Conduct a visual inspection of the contained work area to confirm removal of asbestos-containing materials and for cleanliness prior to taking samples;
5.1.b. Ensure that all sampling equipment is functional and calibrated in accordance with manufacturers specifications, and that a written record of the calibration is maintained;
5.1.c. Ensure that air monitoring incorporates aggressive sampling condition activity to dislodge any remaining dust by sweeping all floors, walls, and ceilings with a leaf blower with a minimum of one (1) horsepower prior to sampling; and by operating one (1) operating stationary twenty inch (20") fan directed at the ceiling for every ten thousand (10,000) cubic feet or fraction thereof in the contained area during sampling;
5.1.d. Ensure that the recommended air volume is drawn on each sampling cassette as prescribed by the analytical method;
5.1.e. Ensure that asbestos abatement projects which take place in schools are completed in compliance with 40 CFR Part 763, Subpart E, Asbestos-Containing Material in Schools;
5.1.f. Ensure that the minimum number of air samples set forth in Table 64-63B found at the end of this rule are collected in non-school asbestos abatement projects; and
5.1.g. Generate a written report to confirm or deny clearance of the contained work areas of an asbestos abatement project at the conclusion of the project.
5.2. The report required by Section 5.1.g of this rule shall include at a minimum the following:
5.2.a. The name and signature of any individual who collected any air sample required by this rule;
5.2.b. The locations indicated by drawings and a sample log where samples were collected;
5.2.c. The date of collection;
5.2.d. The name and address of the laboratory which analyzed the samples;
5.2.e. The date of the analysis;
5.2.f. The results of the analysis;
5.2.g. The method of analysis;
5.2.h. The name and signature of the individual performing the analysis;
5.2.i. Proof that the laboratory meets the applicable requirements of this rule; and
5.2.j. Either a statement clearing the contained work areas for reoccupancy, or a statement denying clearance of the contained work areas, which shall contain an explanation for denying clearance.
W. Va. Code R. § 64-63-6 Minimum Air Clearance Standards
6.1. A contained work area in a school shall be cleared for reoccupancy in accordance with 40 CFR Part 763, Subpart E, Asbestos-Containing Materials in Schools.
6.2. A contained work area in a building or other man-made structure which is not a school may be cleared for reoccupancy when the number of samples required by Section 5.1.f of this rule are taken, and the samples meet the following standards:
6.2.a. 0.01 f/cc (asbestos fibers per cubic centimeter) for each sample analyzed by PCM; or
6.2.b. 0.02 s/cc (asbestos structures per cubic centimeter) for each sample analyzed by TEM.
6.3. Clearance air monitoring is not required for a contained work area in a building or other man-made structure, if the building or other man-made structure is scheduled for immediate demolition.
6.4. When the ambient asbestos fiber or structure level in the air in a contained work area in a building or other man-made structure which is not a school exceeds the minimum clearance standards established in Section 6.2.a or 6.2.b of this rule, the clearance level may, with the prior approval of the director, be based on the level of asbestos fiber or structures in the air outside the contained work area. The samples of air used to determine the asbestos fiber and structure levels in the air inside and outside of the contained work area shall be taken at the same time. The number of samples collected inside and the number collected outside shall each be equal to the number of samples specified in Section 5.1.f of this rule.
W. Va. Code R. § 64-63-7 Asbestos Inspector Duties
Licensed asbestos inspectors shall:
7.1. Thoroughly inspect interior and exterior materials suspected of containing asbestos which may be affected by the renovation or demolition, and sample the material for testing, unless it is assumed to contain asbestos;
7.2. For all asbestos abatement projects, follow the inspection and sampling procedures contained in 40 CFR Part 763, Subpart E, Asbestos-Containing Materials in Schools, to identify interior and exterior materials suspected of containing asbestos; and
7.3. Generate a written report which at a minimum:
7.3.a. Identifies by narrative any sampling locations where the presence of asbestos-containing material has been confirmed;
7.3.b. Details the location and amount of all materials suspected of or assumed to contain asbestos;
7.3.c. Lists analysis results for all samples taken of materials suspected to contain asbestos; and
7.3.d. Includes drawings or narrative descriptions of the locations where bulk samples of materials suspected of containing asbestos were obtained.
W. Va. Code R. § 64-63-8 Asbestos Project Designer Duties
Licensed asbestos project designers shall generate a written project design that provides:
8.1. A chronological time frame for each facet of the abatement activity;
8.2. The name and address of the building or other man-made structure where each asbestos abatement project is to occur;
8.3. The name, address, phone number, and copies of the asbestos-abatement training certificates and licenses of the project designer;
8.4. A schematic floor plan showing the asbestos abatement project area, including a description of the characteristics of the material;
8.5. A statement identifying the abatement activity as repair, removal, encapsulation, or enclosure;
8.6. A schematic floor plan of the containment area which shows the physical dimensions, entrance, exit, windows, decontamination unit, load-out area, emergency exits, placement of the HEPA exhaust air filtration units, any measuring devices, warning signs, and barrier tape;
8.7. The specifications for:
8.7.a. The construction of and the amounts of materials needed to build the project containment area structure, which shall be separated from the uncontaminated environment by polyethylene sheeting or other materials used in conjunction with the existing floors, ceilings, and walls of the structure;
8.7.b. The number and capacity of HEPA exhaust air filtration units and backups;
8.7.c. Air monitoring of personnel; and
8.7.d. Clearance of the contained work area for reoccupancy, including the number of sample collection points and the analytical method to be employed;
8.8. A schematic location and the specifications for the heating, ventilation and air-conditioning system shut-offs, electrical power, water source, fire exits, fire extinguisher, fire alarm, telephone, tool and equipment room, supply box, air monitoring station, project field office, and bathrooms;
8.9. A description of the work procedures to be used; and
8.10. A description of the materials and tools to be used in the abatement project.
W. Va. Code R. § 64-63-9 Training Accreditation
9.1. The director has the authority to accredit asbestos abatement courses provided within West Virginia. In approving asbestos abatement training courses, the director shall rely on the standards for training courses found at 40 CFR Part 763, Subpart E, Appendix C, Model Accreditation Plan, and these standards are hereby adopted by reference.
9.2. Persons wishing asbestos abatement training course accreditation shall submit an application on forms approved by the Director, together with the fee required by W. Va. Division of Health Administrative Rules, 64 CSR 51, Fees for Services.
W. Va. Code R. § 64-63-10 Responsibilities of Owners
10.1. Except as stated in Sections 10.3 and 10.4 of this rule, the owner of a building or other man-made structure shall ensure that:
10.1.a. Each building or other man-made structure he or she owns is inspected for the presence of asbestos by a licensed asbestos inspector prior to any renovation or demolition activities;
10.1.b. Each asbestos abatement project in the building or other man-made structure is designed by a licensed asbestos abatement designer;
10.1.c. The division is notified at least ten (10) working days prior to commencement of each asbestos abatement project and that the notification fees specified in W. Va. Division of Health Administrative Rules, 64 CSR 51, Fees for Services, are submitted with the notification: Provided, That in an emergency resulting from a sudden unexpected event which is not a planned renovation or demolition, the notification and fees shall be submitted to the division as soon as possible after the emergency, but no later than the next working day following the emergency;
10.1.d. Any other applicable West Virginia and federal notification requirements for asbestos abatement projects are carried out; and
10.1.e. The asbestos clearance air monitor is provided with an accurate and precise written description of the asbestos abatement project prior to the collection of air samples used to determine compliance with clearance standards.
10.2. The owner of a building or other man-made structure may delegate, in writing, the responsibilities for compliance with this section to a person who is responsible for the operation of the building, and may delegate the responsibilities for compliance with State and federal notification requirements for asbestos abatement projects to the person who contracts for the projects.
10.3. For asbestos abatement projects involving less than one hundred sixty (160) square feet or two hundred sixty (260) linear feet of asbestos-containing material in buildings or other man-made structures which are not used as schools, notification may consist of a weekly summary in lieu of separate notifications for each project. The notification fees specified in W. Va. Division of Health Administrative Rules, 64 CSR 51, Fees for Services shall be submitted with the weekly summary.
10.4. The removal of resilient floor covering materials in single-family dwellings is exempt from the notification and fee requirements of this rule.
W. Va. Code R. § 64-63-11 Applicable Federal Standards
All persons licensed under this rule shall comply with the applicable portions of the following federal standards which were in effect as of August 19, 1996 which are hereby incorporated by reference:
11.1. 40 CFR Part 763, Subparts E, Asbestos-Containing Materials in Schools; F, Friable Asbestos-Containing Materials In Schools; and G, Asbestos Abatement Projects;
11.2. 40 CFR Part 61, Subpart M, National Emission Standards for Hazardous Air Pollutants;
11.3. 29 CFR, Part 1926, Safety and Health Regulations for Construction, Subpart D, Occupational Health and Environmental Controls ' 1926.1101, Asbestos; and
11.4. 15 U.S.C. 2646, Toxic Substances Control Act, Section 206.
W. Va. Code R. § 64-63-12 Inspections
The director has the right to enter any asbestos abatement project and to conduct inspections to determine compliance with this rule.
W. Va. Code R. § 64-63-13 Penalties
13.1. The director shall, depending upon the severity of the violation and upon the degree of health hazard created, reprimand, or suspend or revoke the license of an asbestos analytical laboratory, clearance air monitor, contractor, inspector, management planner, project designer, supervisor, worker, or a resilient floor covering worker, if the licensee:
13.1.a. Fraudulently or deceptively obtains or attempts to obtain a license;
13.1.b. Fails at any time to meet the qualifications for a license or to comply with the requirements of W. Va. Code '16-32-1 et seq. or this rule; or
13.1.c. Knowingly falsifies or attempts to falsify documents related to an asbestos abatement project or license.
13.2. The director may impose a civil penalty of not less than two hundred fifty dollars ($250) and not more than five thousand dollars ($5,000) for each separate violation of this rule payable within thirty (30) days of receipt of the penalty notification.
13.3. The director shall investigate all alleged violations of this rule or of W. Va. Code '16-32-1 et seq. reported to the division. Upon the finding of a violation in connection with any asbestos abatement project the director shall, depending upon the severity of the violation and upon the degree of health hazard created, initiate an appropriate enforcement action which may include the issuance of a cease and desist order directing that all work on the project be halted immediately. Posting of the cease and desist order on the project site constitutes notice of its contents to the property owner and all persons working on the asbestos abatement project. Where practicable, however, the director shall deliver a copy of the order by certified mail, return receipt requested, to the property owner and to the contractor.
13.4. In any case where a person fails to halt work following the issuance of a cease and desist order by the director, the violation is presumed to be willful and the person shall be assessed a civil penalty by the director of not less than ten thousand dollars ($10,000) nor more than twenty-five thousand dollars ($25,000) for an initial violation and not less than twenty-five thousand dollars ($25,000) nor more than fifty thousand dollars ($50,000) for each subsequent violation payable within thirty (30) days of receipt of the penalty notification.
13.5. Any person who violates any provision of this rule or of the W. Va. Code ' 16-32-1 et seq. is guilty of a misdemeanor.
W. Va. Code R. § 64-63-14 Administrative Due Process
Those persons adversely affected by the enforcement of this rule desiring a contested case hearing to determine any rights, duties, interests or privileges shall do so in a manner prescribed in W. Va. Division of Health Administrative Rules, Rules and Procedures for Contested Case Hearings and Declaratory Rulings, 64 CSR 1.
Table 64-63A. Licensure Fee Schedule.
Type of License Fee Asbestos Worker Asbestos Inspector Asbestos Project Designer Asbestos Supervisor Asbestos Management Planner Asbestos Clearance Air Monitor Asbestos Contractor Asbestos Analytical Laboratory Air Sample Analysis Only Bulk Sample Analysis Only Bulk and Air Sample Analysis Resilient Floor Covering Worker $ 50 Table 64-63B. Minimum Number of Air Samples for Non-School Asbestos Abatement Projects.
Size of Contained Work Area Minimum Number of Samples 49 ft2 50 - 160 ft2 161 - 2,500 ft2 2,501 - 5,000 ft2 5,001 - 10,000 ft2 >10,000 ft2 Calculate* *Five (5) samples plus one (1) additional sample for each additional 5,000 square feet.
The Department of Health and Human Resources (DHHR) was created by the Legislature's reorganization of the executive branch of State government in 1989, and the Department of Health was renamed the Division of Health and made a part of the DHHR (W. Va. Code '5F-1-1 et seq.). Administratively within the DHHR the Bureau for Public Health through its Commissioner carries out the public health function of the Division of Health.
See footnote #1.
64CSR63
Series 64 Aids-Related Medical Testing and Confidentiality
W. Va. Code R. § 64-64-1 General
1.1. Scope -- This legislative rule establishes specific standards and procedures concerning AIDSrelated medical testing; record confidentiality and disclosure; consent for testing by a legal representative; exclusion from schools; reporting requirements for physicians, laboratories and other health care providers; the approval of laboratories for HIV testing; and other matters pertinent and necessary for the implementation of the AIDS-Related Medical Testing and Records Confidentiality Act, W. Va. Code § 16-3C-1, et seq.
This rule supplements the AIDS-Related Medical Testing and Records Confidentiality Act, W. Va.
Code § 16-3C-1 et seq., and should be read in conjunction with the Act.
1.2. Authority -- W. Va. Code §§16-1-4, 16-1-11(a), 16-3C-8, and 16-5J-3.
1.3. Filing Date -- April 28, 2016
1.4. Effective Date -- July 1, 2016
W. Va. Code R. § 64-64-2 Application and Enforcement
2.1. Application -- This rule applies to:
2.1.a. Health facilities;
2.1.b. Health care providers;
2.1.c. Funeral service providers and personnel;
2.1.d. Schools;
2.1.e. Persons with access to or in charge of medical records or other sources of information regarding AIDS-related testing information;
2.1.f. Laboratories seeking approval to conduct AIDS-related tests to be used in this State;
2.1.g. Health care providers or emergency responders and their employers;
2.1.h. Spouses, sexual contacts and intravenous (IV) drug contacts who may be at risk of having acquired the HIV infection as a result of the possible exchange of body fluids; and
2.1.i. Law enforcement, prosecuting attorneys and judicial officers involved with charging and adjudicating persons for sexual offenses as set forth in W. Va. Code § 16-3C-2(f)(2).
2.2. Enforcement -- This rule is enforced by the Commissioner of the Bureau for Public Health or his or her lawful designee.
W. Va. Code R. § 64-64-3 Definitions
The following definitions of terms are in addition to those in W. Va. Code § 16-3C-1.
3.1. Anonymous HIV Testing -- HIV testing performed on a voluntary patient by a health care provider with no knowledge of the person's identity.
3.2. Body Fluids -- Substances that have been implicated in the transmission of HIV that include:
3.2.a. Blood, semen, vaginal secretions or other body fluids contaminated with visible blood; and
3.2.b. Cerebrospinal, oral, synovial, pleural, peritoneal, pericardial, and amniotic fluids, which have an undetermined risk for transmitting HIV.
3.3. Bureau -- The Bureau for Public Health in the Department of Health and Human Resources.
3.4. CLIA-88 -- Clinical Laboratory Improvement Amendments of 1988 (Public Law 100-578) to
Section 353 of the Public Health Service Act (Title 42 U.S.C. § 263a).
3.5. Commissioner - The Commissioner of the Bureau for Public Health.
3.6. Confidential HIV Testing -- HIV testing performed by a health care provider identifying the patient by name. The use of test results is limited by law.
3.7. Contact -- When used as a noun, a sexual or needle-sharing partner.
3.8. Convicted -- Pleas of guilty and pleas of nolo contendere accepted by the court having jurisdiction of the criminal prosecution, a finding of guilty following a jury trial to a court, and a juvenile delinquent or status offender as defined in W. Va. Code § 49-1-202.
3.9. Funeral Director. -- Any person engaged, or holding himself or herself out as engaged, in the business of funeral directing as defined in W. Va. Code §§ 30-6-3(0) and (p), and who uses in connection with his or her name or business the words or terms "funeral director," "undertaker," "mortician," or any other word, term, or title to imply or designate himself or herself as a funeral director, undertaker, or mortician.
3.10. Funeral Establishment -- A licensed place of business devoted to: the care, preparation and arrangements for the transporting, embalming, funeral, burial or other disposition of a deceased. A funeral establishment includes a licensed crematory.
3.11. HIV-Infected Person -- A person who has been diagnosed with AIDS or who has a positive confirmatory test for HIV.
3.12. Legal Representative -- A person from whom substituted consent may be obtained as provided for in W. Va. Code § 16-3C-4 for HIV-related testing or for the authorization of the release of test results.
3.13. Physician -- A person licensed under W. Va. Code § 30-3-1, et seq., to practice medicine.
3.14. Post-Exposure Care -- Care including an initial HIV test following exposure and United States Centers for Disease Control and Prevention (CDC) currently recommended follow-up HIV testing, counseling, medical evaluation and provision for post-exposure prophylactic treatment.
3.15. Source Patient -- Any person whose body fluids have been the source of a significant exposure to a health care provider or emergency responder or other person.
W. Va. Code R. § 64-64-4 Testing
4.1. Consent.
4.1.a. All health-care providers shall recommend HIV-related testing as part of a routine screening for treatable conditions and as a part of routine prenatal and perinatal care. The HIV-related testing provided for in W. Va. Code §§ 16-3C-2(a) through (d) may also be requested by a health care provider acting within the scope of his or her professional license.
4.1.b. The provisions of W. Va. Code §§ 16-3C-2(b) through (d) shall also be followed when a patient, without a request from a physician, dentist, other health care provider acting within the scope of his or her professional practice, or the Bureau, voluntarily seeks an HIV test from any physician, dentist, other health care provider, or from the Bureau.
4.1.b.1. Patients shall be informed either orally or in writing that HIV-related testing is performed as a part of routine care, that HIV-related testing is voluntary and that the patient may decline HIV-related testing (opt-out); or
4.1.b.2. Patients shall be informed that his or her general consent for medical care includes consent for HIV-related testing.
4.1.c. Nothing in this rule shall be construed to provide grounds for any physician, dentist, other health care provider or the Commissioner to refuse to treat a patient, nor shall the testing provisions of this rule be used by health care providers to screen patients.
4.1.d. HIV screening for pregnant women and their infants.
4.1.d.1. Health care providers shall notify a pregnant patient that HIV screening is recommended and that she will be tested for HIV as part of the routine panel of prenatal tests, unless she declines through the mechanism of opting out.
4.1.d.2. HIV testing of pregnant women should be voluntary and free from coercion. No woman shall be tested without her knowledge, unless in accordance with subdivision 4.2.c. of this
section.
4.1.d.3. Pregnant women shall receive oral or written information that includes an explanation of HIV infection, a description of interventions that can reduce HIV transmission from mother to infant, and the meanings of positive and negative test results and she shall be offered an opportunity to ask questions and to decline testing.
4.1.d.4. It is recommended that health care providers test women as early as possible during each pregnancy. Women who decline the test early in prenatal care may be encouraged to be tested at subsequent visits.
4.1.d.5. A second HIV test during the third trimester, preferably prior to the 36th week of gestation, is cost-effective even in areas of low HIV prevalence and may be considered for all pregnant women. A second HIV test during the third trimester is also recommended for women who meet one or more of the following criteria:
4.1.d.5.A. The woman received health care in facilities in which prenatal screening identifies at least one HIV-infected pregnant woman per 1,000 women screened;
4.1.d.5.B. The woman is known to be at high risk for acquiring HIV, for example, injection- drug users and their sexual partners, women who exchange sex for money or drugs, women who are sex partners of HIV-infected persons and women who have had a new or more than one sex partner during the pregnancy; or
4.1.d.5.C. A woman who has signs or symptoms consistent with acute HIV infection.
4.1.e. The bureau may charge the reasonable cost for HIV laboratory analysis done at the state hygienic laboratory. The cost of the test may not be passed through to the patient by a public health department.
4.2. Consent Not Required.
4.2.a. Consent for testing is not required and the provisions of W. Va. Code § 16-3C-2(b) and Subsection 4.1. of this rule does not apply for the performance of an HIV test:
4.2.a.1. On a human body part as provided in W. Va. Code § 16-3C-2(e)(1). HIV testing shall be required of the donor and recipient of the human body part.
4.2.a.1.A. All confidentiality restrictions contained in Section 8 of this rule and in W. Va.
Code § 16-3C-3 apply to information obtained through the testing of human body parts, tissue, blood, blood products, or semen;
4.2.a.1.B. Consent for HIV-related testing is required for donors of routine blood transfusions, and the provisions of W. Va. Code § 16-3C-2(e)(1) do not apply to those transfusions;
4.2.a.2. In documented bona fide medical emergencies as provided for in W. Va. Code §16- 3C-2(e)(2) and as determined by a treating physician taking into account the nature and extent of the exposure to another person, whether the source patient's blood is to be obtained or is already available:
Provided, That:
4.2.a.2.A. The source patient is unable or unwilling to grant or withhold consent, and if the source patient is unable to grant or withhold consent, substituted consent is not obtained after a reasonable attempt is made to obtain consent from a legal representative of the source patient in accordance with W. Va. Code § 16-3C-4. For the purposes of this section a reasonable attempt includes but is not limited to: a telephone call or personal contact;
4.2.a.2.B. The test results are necessary for medical diagnostic purposes to provide appropriate emergency care or treatment, and the HIV testing for a source patient is conducted only after a health care provider, as qualified in Subsection 7.1 of this rule, documents in the medical record of a health care provider or emergency responder or another person who has come into contact with a source patient that there has been a significant exposure of the emergency responder or person and that in the medical judgment of that health care provider the results are medically necessary to determine the course of treatment for the exposed emergency responder or person; and
4.2.a.2.B.1. A reasonable attempt is made to contact the source patient, or the source patient's legal representative if the source patient is unable to grant or withhold consent, to inform him or her that the test will be performed using a pseudonym;
4.2.a.2.B.2. The test results are offered to the source patient, and any refusal of acceptance is documented only in the medical record of the exposed health care provider or emergency responder or other exposed person;
4.2.a.2.B.3. None of the activities set forth in this subsection are documented in the source patient's medical record. The health care facility and the health care provider or emergency responder shall maintain confidentiality. If any improper disclosure occurs, the source patient may invoke the remedies and penalties of W. Va. Code § 16-3C-5; and
4.2.a.3. For the purpose of research in accordance with W. Va. Code § 16-3C-2(e)(3).
4.2.b. For a test performed under the authority of W. Va. Code § 16-3C-2(f)(9), the Commissioner may, at his or her discretion, release the test result to the physician or other health care provider who requested the test: Provided, That the provisions of Section 8 of this rule and W. Va. Code
§ 16-3C-3 regarding confidentiality and disclosure apply. The Commissioner may establish a list of health care providers who are approved to authorize HIV testing in emergency medical aid circumstances.
4.2.c. If the pregnant woman's HIV status is unknown at the time she presents for delivery, an HIV test shall be offered and if she refuses the test, the infant may be tested and the mother shall be informed of the testing and the results.
4.2.c.1. The rapid testing of newborns is recommended as soon as possible after birth so antiretroviral prophylaxis can be offered to HIV-exposed infants when the woman's HIV status is unknown postpartum. The woman shall be informed that identifying HIV antibodies in the newborn indicates that the woman is infected.
4.2.c.2. For infants whose HIV exposure status is unknown and who are in foster care, the person legally authorized to provide consent shall be informed that HIV testing is recommended for infants whose biologic mothers have not been tested.
4.3. Mandated HIV Testing.
4.3.a. The testing of a person charged with or convicted of a sex-related offense as specified in W. Va. Code § 16-3C-2(f) does not require consent of that person and is under the direction of the magistrate or circuit court as specified in this subsection. Counseling may be offered.
4.3.b. The magistrate or circuit court having jurisdiction of the initial stages of the criminal prosecution or juvenile delinquency proceeding shall order that an HIV-related test be performed on any person charged with a sexual offense. The testing shall occur as follows:
4.3.b.1. A court shall order a defendant or juvenile charged with an offense set forth in W.
Va. Code § 16-3C-2(f)(2), to undergo a test for HIV not later than 48 hours after the date on which the initial appearance is made.
4.3.b.1.A. The court shall require the defendant or juvenile respondent to submit to the testing not later than forty-eight hours after the issuance of the order described in paragraph 4.3.b.1 of this subsection, unless good cause for delay is shown upon a request for a hearing: Provided, That no such delay shall cause the HIV-related testing to be administered later than forty-eight hours after the filing of any indictment or information regarding an adult defendant or the filing of a petition regarding a juvenile respondent.
4.3.b.1.B. The prosecuting attorney may, upon the request of the victim or the victim's parent or legal guardian, and with notice to the defendant or juvenile respondent, apply to the court for an order directing that an appropriate human immunodeficiency virus (HIV) test or other STD test, be performed on a defendant charged with or a juvenile subject to a petition involving the offenses of prostitution, sexual abuse, sexual assault or incest.
4.3.b.2. As soon as practical, test results shall be provided to the magistrate court clerk in the county where the defendant or juvenile respondent is charged. If the criminal matter or juvenile delinquency proceeding is then pending before the circuit court, the magistrate clerk shall immediately forward the test results to the circuit clerk. The clerk shall also promptly provide a copy of the test results to: 1) the prosecuting attorney, who shall inform the victim, or parent or legal guardian of the victim; and 2) counsel for the defendant or juvenile respondent.
4.3.b.3. The court may, at any time during which the charge or juvenile petition is pending, order that the defendant or juvenile submit to one or more appropriate tests to determine if he or she is infected with any sexually transmitted disease.
4.3.b.4. The court may also order follow-up tests for HIV as may be medically necessary or appropriate. The results of any such follow-up tests shall be provided as soon as possible in accordance with paragraph 4.3.b.3. of this subdivision.
4.3.b.5. The costs of testing may be charged to the defendant or juvenile respondent, or to that person's medical insurance provider, unless determined unable to pay by the court having jurisdiction over the matter. If the defendant or juvenile is unable to pay, the cost of laboratory testing for HIV may be borne by the bureau or the local health department.
4.3.b.5.A. The commissioner designates and authorizes all health care providers operating in regional jails, correctional or juvenile facilities to administer HIV tests, either by taking blood or oral specimens, and transmitting those specimens to the Office of Laboratory Services in accordance with instructions set forth at: http://www.wvdhhr.org/labservices/labs/HIV/index.cfm.
4.3.b.5.B. Laboratory testing done on specimens sent to the Office of Laboratory Services by health care providers for regional jails, correctional or juvenile facilities shall be performed at no cost to the jails, facilities or health care providers.
4.3.b.6. HIV testing may be performed either by an oral test or by drawing blood and the test shall be done either at the correctional facility where the defendant or juvenile respondent is housed, or at the local health department in the individual's county of residence, or at an alternative health care facility designated in the order.
4.3.c. The Commissioner shall request access to all convicted sex offenders who test HIV positive for the purposes of contact notification consultation under the direction of the Commissioner.
Contact notification information obtained from the convicted sex offender is protected information and shall be used by the Commissioner solely for referring individuals with a potential HIV exposure to HIV counseling and testing sources.
4.3.d. A person convicted or a juvenile adjudicated of the offenses described in this subsection may be required to undergo HIV-related testing and counseling immediately upon conviction or adjudication: Provided, That if the person convicted or adjudicated has been tested in accordance with the provisions of subdivision 4.3.b.of this subsection, that person need not be retested.
4.3.e. The HIV-related test result obtained from the convicted or adjudicated person is to be transmitted to the court and to the victim or the parent or legal guardian of the victim and after the convicted or adjudicated person is sentenced or disposition ordered for the adjudicated juvenile, the result of the HIV test shall be made part of the court record. If the convicted or adjudicated person is placed in the custody of the Division of Corrections or Regional Jail and Correctional Facility Authority, or if the adjudicated juvenile is placed in the custody of the Division of Juvenile Services or other out-of-home placement, the court shall transmit a copy of the convicted or adjudicated person's HIV-related test results to the appropriate custodial agency. The HIV-related test results shall be closed and confidential and disclosed by the court and the bureau only in accordance with the provisions of this subsection and
section three of this article.
W. Va. Code R. § 64-64-5 Cease and Desist Orders
5.1. A cease and desist order issued under the authority of W. Va. Code § 16-3C-2(f)(4) shall be in writing, and shall set forth the name of the person to be restricted, and the initial period of time during which the order remains effective, the terms of the restrictions and other conditions that are warranted to protect the public health.
5.2. If any person violates a cease and desist order issued pursuant to this rule and W. Va. Code § 16- 3C-2(f)(5) and the person is a danger to the health of others, the Commissioner shall apply to the circuit court of Kanawha County to enforce the cease and desist order by imposing any restrictions upon the person that are necessary to prevent the specific conduct which endangers the health of others, including pre-trial detention or incarceration.
W. Va. Code R. § 64-64-6 Charting Information
A health care provider shall enter the confirmed positive results of an HIV-related test in each patient's chart or in the patient's electronic health record through the Health Information Exchange (HIE).
W. Va. Code R. § 64-64-7 Post-Exposure Care and Treatment
7.1. A health facility shall have access to a knowledgeable trained health care provider to assess the HIV exposure risk of health care providers, emergency responders or other persons during all working hours, including nights and weekends. The assessment of HIV exposure risk and initiation of basic postexposure care regimen requires knowledge or experience in clinical epidemiology, infection control, occupational health, or the clinical treatment of HIV. Consultation with subject matter experts on the facility's currently accepted practice, when prescribing post-exposure prophylaxis, is strongly encouraged.
7.2. A health facility shall have a written post-exposure HIV management plan patterned after current recommendations of the United States Centers for Disease Control and Prevention (CDC).
7.3. A laboratory shall not determine a test result to be positive, and a health care provider shall not reveal a positive test result to any person, without conducting corroborating or confirmatory testing.
However, a laboratory may release preliminary test results to the health care provider assessing the significant exposure for the purposes of determining post-exposure management of the health care provider, emergency responder or other person.
7.4. Health care providers shall report all confirmed positive test results to the Bureau in compliance with Section 12 of this rule.
7.5. The employer of a health care provider or emergency responder who was exposed while performing a duty of his or her employment shall bear the costs of HIV tests of blood or oral samples of the source patient and the health care provider or emergency responder, unless a workers' compensation or other benefit program affords coverage for the testing. For a health care provider or emergency responder who tested negative for HIV antibodies immediately following the exposure, the employer shall also bear the costs of the CDC's recommended initial prophylactic treatment and additional HIV testing at three and six months after exposure, unless a workers' compensation or other job-related employee benefit program affords coverage for the treatment and testing.
7.6. Relative to the management of source patient medical information, the health care provider or emergency responder reporting a significant exposure is subject to the requirements of the disclosure statement contained in W. Va. Code §16-3C-3(c) and to the remedies and penalties specified in W. Va.
Code §16-3C-5.
W. Va. Code R. § 64-64-8 Confidentiality and Disclosure
8.1. The victims or alleged victims of sexual crimes are eligible for HIV counseling and testing at public health HIV testing sites in West Virginia. The provisions of this rule and W. Va. Code § 16-3C-1 et seq. regarding voluntary testing apply to testing and counseling of these persons. All victim testing information is subject to the confidentiality requirements of this rule and W. Va. Code § 16-3C-1 et seq. for voluntary testing.
8.2. An agent or employee of a health facility or health care provider has a need to know HIV test results under the provisions of W. Va. Code § 16-3C-3(a)(4) when the information is medically necessary to protect the individual from a significant risk of transmission or will have an impact on the treatment modality.
8.3. HIV test results may be disclosed to health care providers, emergency responders or others who have been subject to a significant exposure during the course of medical practice or in the performance of professional duties. The health care provider or emergency responder is subject to the requirements of the disclosure statement contained in W. Va. Code § 16-3C-3(c) and to the remedies and penalties provided in W. Va. Code § 16-5C-5.
8.4. Solely for the purpose of prompt and accurate evaluation and payment of medical or related claims HIV test results may be disclosed to claims management personnel employed by or associated with an insurer, health care service contractor, health maintenance organization, self-funded health plan, state-administered health care claims payer or any other payer of health care claims. Information released under this subsection is confidential and shall not be released or made available to persons who are not involved in handling or determining medical claims payment.
8.5. HIV test results may be disclosed to facilitate health information exchanges and to legally authorized public health authorities.
8.6. HIV test results may be disclosed to persons allowed access to the record by a court order issued in accordance with the provisions of W. Va. Code § 16-3C-3(11).
W. Va. Code R. § 64-64-9 Contact and Partner Notification
9.1. Notification made by the Commissioner under W. Va. Code § 16-3C-3(d) shall include an explanation of exposure to HIV, HIV prevention messages and information on accessibility to HIV counseling and testing services to the contact with a reported HIV exposure. The confidentiality rules that apply to the names of HIV-infected persons shall apply to the names of their contacts.
9.2. In contact notification situations, the Bureau recommends that a private health care provider refer contact notification activities to the Bureau rather than attempt notification itself. The Bureau has an established program for notifying partners of persons with infectious conditions; including but not limited to the Internet Partner Services Protocol available at: http://www.dhhr.wv.gov/oeps/std-hiv-hep.
W. Va. Code R. § 64-64-10 Consent by Legal Representative
10.1. Substituted consent for HIV-related testing or for the authorization of the release of test results shall be obtained in accordance with W. Va. Code § 16-3C-4 and this rule.
10.2. Minors shall be treated as established under W. Va. Code § 16-4-10.
W. Va. Code R. § 64-64-11 School Exclusion
School exclusions shall be in accordance with W.Va. Code §16-3C-6. If the student is under the jurisdiction of a protection or advocacy agency, a representative from that agency may be included in consultation. The provisions of this rule and of W.Va. Code §16-3C-1, et seq. regarding the confidentiality and the release of information are applicable in the school setting.
W. Va. Code R. § 64-64-12 Requirement for All Health Care Providers to Report Positive Tests for the Human Immunodeficiency Virus
12.1. In accordance with the Bureau for Public Health's rule, Reportable Diseases, Events and Conditions, 64CSR7, all health care providers in West Virginia who perform, or cause to have performed, serologic or other tests for HIV shall report all HIV infection associated with laboratory tests that are positive or results, including but not limited to all values of CD4 count and any results from a viral load that are either indicative of or a progression toward the HIV infection to the Commissioner on forms provided by the Commissioner or via electronic reporting (http://www.dhhr.wv.gov/oeps/std-hivhep/disease_reporting/Pages/default.aspx) to include:
12.1.a. All positive (reactive) laboratory test results; and
12.1.b. All clinical status data.
12.2. A health care provider report shall include:
12.2.a. The name and full address of the laboratory;
12.2.b. The name of the tests performed, the date each test was performed and the results of the tests;
12.2.c. The legibly printed or typed name and location of the health care provider reporting the positive HIV laboratory results;
12.2.d. The name of the confidentially-tested individual;
12.2.e. The patient's demographic information including the patient's age, sex, race and address, unless the patient requests anonymous reporting;
12.2.f. Social and risk factor information of the patient relative to HIV infection; and
12.2.g. Other information concerning HIV infection judged necessary by the Commissioner.
12.3. A confirmed positive report of HIV shall be submitted within seven days of the receipt of the test results.
12.4. Health care providers performing anonymous HIV testing on patients shall use confidential reporting of HIV infection for patients revealing his or her identity in HIV infection consultation. If a patient who has been tested anonymously, either makes his or her identity known to the health care provider or rescinds the request for anonymity, the health care provider shall report the name to the Commissioner.
12.5. The Commissioner shall work with a patient's health care provider in any follow-up of reported positive laboratory tests or HIV infection.
12.6. A Health care provider who provides HIV care to patients on the basis of a medical or a selfreferral shall submit an HIV infection report form to the Bureau.
12.7. The reports of all HIV infection submitted in compliance with this rule are protected and are exempt from public disclosure under the exemption for medical records contained in W. Va. Code §29B- 1-1 et seq., the Freedom of Information Act: Provided, That the reports are subject to the provisions of W. Va. Code §16-3C-1 et seq. This information in the reports shall not be used, except as necessary, to enforce State public health laws and rules and to analyze the magnitude of HIV infection in this State for assisting in the development of adequate safeguards against its spread.
W. Va. Code R. § 64-64-13 Requirement for Laboratories to Report Positive Tests for the Human Immunodeficiency Virus
13.1. All laboratories conducting HIV testing in West Virginia or providing HIV testing results for use in this State shall make a report on the first and fifteenth days of each month of all laboratory tests, including but not limited to all values of CD4 count and any results from a viral load that are positive or results that are indicative of the HIV infection to the Commissioner on forms provided by the Commissioner (http://www.dhhr.wv.gov/oeps/std-hiv-hep/disease_reporting/Pages/default.aspx) or by electronic transmittal for that purpose to include:
13.1.a. All CLIA certified tests that are intended to diagnose or document HIV infection, including, but not limited to, viral load, P24 antigen and western blot tests and;
13.1.b. All values of CD4 count and any results from a viral load.
13.2. These reports shall include:
13.2.a. The name and full address of the laboratory;
13.2.b. The name of the test, the date performed, and the result;
13.2.c. The name and location of the health care provider who submitted the specimen;
13.2.d. The name of the patient;
13.2.e. Other information concerning HIV infection management and control judged necessary by the Commissioner; and
13.2.f. The signature of the supervisor of the laboratory.
13.3. The laboratory shall submit the results of the laboratory reports related to subsections 13.1.a and
13.1.b of this rule on the first and fifteenth days of each month.
13.4. If no reportable tests are performed during a reporting period, a statement to this effect shall be submitted by the supervisor of the laboratory.
13.5. The Commissioner shall work with a patient's health care provider in any follow-up of the reports of confirmed positive laboratory tests.
13.6. The reports of all positive tests submitted in compliance with this rule are protected and are exempt from public disclosure under the exemption for medical records contained in W. Va. Code §29B- 1-1 et seq., the Freedom of Information Act: Provided, That the reports are subject to the provisions of W. Va. Code §16-3C-1 et seq. The information in the reports shall not be used except as is necessary to enforce State public health laws and rules and to analyze the magnitude of HIV infection in the State for assisting in the development of adequate safeguards against its spread.
W. Va. Code R. § 64-64-14 Quality Assessment of Laboratories Conducting HIV Tests
14.1. Laboratories Required to be Approved.
14.1.a. All laboratories conducting HIV testing in this State or providing HIV testing results for use in this State shall be approved by the Bureau.
14.1.b. A laboratory located in West Virginia and seeking approval shall:
14.1.b.1. Show that it complies with the applicable requirements of W. Va. Code §16-3C-1, et seq. and this rule;
14.1.b.2. Complete application forms when seeking initial approval or when there is a change in director, owner, location or testing method;
14.1.b.3. Be certified to perform waived or non-waived (moderate or high) complexity HIV testing following at a minimum the test categorization requirements in accordance with the provisions of the federal regulations promulgated pursuant to the Clinical Laboratory Improvement Amendment (CLIA-1988) 42 CFR Part 493, as revised October 1, 2006; and
14.1.b.4. Pay a fee of thirty dollars annually for each laboratory providing HIV testing located in West Virginia.
14.1.c. A laboratory located outside of West Virginia conducting HIV testing on West Virginia patients is eligible for approval only if it is approved for non-waived (moderate or high complexity) laboratory testing by the federal government regulations promulgated pursuant to CLIA-88 as revised October 1, 2006 and/or Centers for Medicare and Medicaid Services (CMS) approved accreditation agency. The laboratory shall complete an application and submit a forty dollar fee when seeking initial approval. Each out-of-state laboratory shall also submit an annual renewal fee of forty dollars to the Office of Laboratory Services.
14.2. Laboratory Director and Personnel Qualifications.
14.2.a. The laboratory director and personnel shall at a minimum meet the qualifications set forth by the federal government pursuant to CLIA for certification of laboratories 42 CFR Part 493, Laboratory Requirements, as amended in the October 1, 2006, edition of the Federal Register (60 FR 20035), are hereby incorporated by reference.
14.2.b. The person specified as the laboratory director on the CMS issued CLIA certificate is ultimately responsible for the reliability of HIV testing. The laboratory director shall be a licensed medical professional acting within the scope of his or her license.
14.2.c. For waived HIV testing methods only, while there are no formal educational requirements for testing personnel, the director shall assure the testing personnel are properly trained and competent.
14.3. Quality Assessment Standards.
A laboratory requesting approval shall demonstrate that a quality assessment program acceptable to the Bureau is in effect for verification and assessment of accuracy, measurement, precision, and detection of laboratory errors. This demonstration shall be evidenced, when applicable, in part by:
14.3.a. The selection of test methods appropriate to the needs of persons served by the laboratory;
14.3.b. The use of quality controls and calibrating standards;
14.3.c. The recording of the acceptable limits and the results of controls and calibrating standards;
14.3.d. The recording of quality assessment activities; including, but not limited to, calibration, quality control, corrective action, preventative maintenance and patient test management;
14.3.e. The labeling and dating of all reagents, solutions, standards, and quality control materials;
14.3.f. Following HIV test method manufacturer requirements approved by the Federal Food and Drug Administration (FDA); and
14.3.g. Maintaining a site specific manual containing all procedures and policies currently in use, which shall include action to be taken when control results are outside the acceptable limits and the procedure for reporting positive HIV test results to the Bureau along with protocols for reporting HIV testing to the Bureau.
14.4. Proficiency Testing, Personnel Competency Assessment.
Laboratories shall participate in a CLIA approved HIV proficiency testing survey or an alternative HIV testing personnel competency assessment program approved by the Bureau and in accordance with CLIA-88 Proficiency testing requirement by test complexity. The assessment shall be conducted biannually and satisfactory performance by the laboratory is mandatory. The laboratory shall forward proficiency testing survey results to the Bureau.
14.5. On-site Inspection.
The Commissioner or his or her designee may conduct an on-site inspection or a paper or electronic survey to determine compliance with this rule initially prior to approval, and thereafter as frequently as the Commissioner considers necessary to insure compliance with this subsection. The Bureau has the right of entry upon proper identification at times judged necessary during operating hours in order to conduct the inspections.
14.6. Certificate of Approval; Revocation.
14.6.a. The Commissioner shall issue certificates of approval for a laboratory to perform HIV testing upon initial approval and on an annual basis thereafter pursuant to the conditions listed in this rule.
Certificates issued shall contain the name and location of the laboratory, a laboratory code number, the name of the laboratory director and the date of expiration of the certificate.
14.6.b. Laboratories shall notify the Bureau when there is a change in ownership, laboratory director, testing method or location of the testing laboratory. In the case of mobile laboratory programs, the certificate shall be issued to the mobile laboratory's home-based address.
14.6.c. The Commissioner may revoke or suspend a laboratory's approval if the laboratory:
14.6.c.1. Performs unsatisfactorily in on-site inspections;
14.6.c.2. Fails to comply with this rule and all applicable provisions of W.Va. Code §16-3C- 1, et seq .;
14.6.c.3. Fails to report positive test results to the Bureau in accordance with W.Va. Code
§16-3C-8B and this rule; or
14.6.c.4. Closes.
W. Va. Code R. § 64-64-15 Administrative Due Process
Those persons adversely affected by the enforcement of this rule desiring a contested case hearing to determine any rights, duties, interests or privileges shall do so in a manner prescribed in the Bureau for Public Health rule, Rules of Procedure for Contested Case Hearings and Declaratory Rulings, 64 CSR 1.
Series 68 Cancer Registry
W. Va. Code R. § 64-68-1 General
1.1. Scope. -- This legislative rule establishes standards and procedures for reporting cancer cases to the West Virginia Cancer Registry, maintaining the confidentiality of information in its cancer registry and disclosing information from the cancer registry.
1.2. Authority. -- W. Va. Code §§16-1-4, 16-1-11(a) and 16-5A-2a(e).
1.3. Filing Date. -- April 11 , 2014.
1.4. Effective Date. -- May 11, 2014.
W. Va. Code R. § 64-68-2 Application and Enforcement
2.1. Application. -- This rule applies to health care providers, health care facilities and persons with access to or in charge of medical records or other sources of cancer-related information.
2.2. Enforcement. -- This rule is enforced by the commissioner of the bureau for public health.
W. Va. Code R. § 64-68-3 Definitions
3.1. Abstract -- A summary of information relating to the diagnosis and course of disease of an individual case of cancer.
3.2. Bureau – The bureau for public health in the department of health and human resources.
3.3. Cancer -- A cellular tumor, the natural course of which is fatal and usually associated with the formation of secondary tumors.
3.4. Cancer Registry -- A registry maintained for the collection of information concerning newly diagnosed cancer cases.
3.5. Commissioner -- The commissioner of the bureau for public health in the department of health and human resources or his or her designee.
3.6. Confidential Information -- Information which identifies individual cancer patients, health care facilities or health care providers.
3.7. Data linkages – The service that the Bureau provides to cancer researchers or other qualified individuals or healthcare facilities that involves the linkage of an external data file to individual level data maintained in the West Virginia Cancer Registry.
3.8. Diagnosis -- The determination of the nature of a case of disease.
3.9. Health Care Facility -- Any hospital, nursing home, clinic, cancer treatment center, laboratory, or any other facility or institution which provides health care or diagnostic services to individuals.
3.10. Health Care Provider -- Any physician, dentist, nurse, or other individual who provides to individuals medical, dental, nursing, or other health care services of any kind.
3.11. Hospital -- An entity subject to licensure as a hospital under WV Code §16-5B-1.
3.12. Person -- An individual, partnership, corporation or other legal entity.
3.13. Reportable Cancer Case -- Any case of cancer diagnosed after December 31, 1992, where the primary tumor is determined to be malignant or carcinoma in situ, with the exception of basal cell or squamous cell carcinomas of the skin and carcinoma in situ of the cervix.
3.14. Reporting Source -- A health care facility or provider which diagnoses or provides treatment for cancer.
3.15. West Virginia Cancer Registry -- The office within the bureau for public health which collects and maintains information on cancer cases.
W. Va. Code R. § 64-68-4 Reporting
4.1. All reporting sources shall provide the West Virginia Cancer Registry with the following patient-related information on all reportable cancer cases to the extent that the information would be routinely available at a particular type of reporting source:
4.1.a. The last name, first name, and middle initial;
4.1.b. Social security number;
4.1.c. Sex;
4.1.d. Birth date;
4.1.e. Maiden name;
4.1.f. Race/ethnicity;
4.1.g. Physical address at the time of diagnosis, including street, city, county and zip code, state and country or the mailing address at the time of diagnosis if physical address is unavailable;
4.1.h. Date of diagnosis;
4.1.i. A description of the cancer, including site, type, and any other information needed to describe the case clearly;
4.1.j. Stage of disease at diagnosis using:
4.1.j.1. Surveillance, Epidemiology, and End Results (SEER) system;
4.1.j.2. American Joint Committee on Cancer (AJCC) system if maintained by the reporting source; and
4.1.j.3. Collaborative Stage Data Collection System.
4.1.k. The treatment of the cancer and the patient’s medical status;
4.1.l. Date of death, if the patient has died;
4.1.m. Cause of death;
4.1.n. Usual occupation;
4.1.o. Usual industry of employment;
4.1.p. Name of patient’s health insurance provider;
4.1.q. Marital status;
4.1.r. Other information relevant for the identification of hazards to the public, i.e., the presence of factors placing the patient at risk for development of cancer. Risk factor information includes, but is not limited to: tobacco use, familial history of cancer and alcohol use; and
4.1.s. Other data elements required by the Centers for Disease Control and Prevention (CDC) National Program of Cancer Registries (NPCR).
4.2. Each cancer case report shall also include:
4.2.a. The name of the reporting source;
4.2.b. The name of the diagnosing physician and treating physician; and
4.2.c. Sufficient narrative to determine the accuracy of coding and information.
4.3. Features of Health care facility reporting.
4.3.a. Any health care facility diagnosing or treating cancer patients within the state of West Virginia shall submit the required information on all reportable cases of cancer served by that facility to the West Virginia Cancer Registry within six months of diagnosis.
4.3.b. Reports shall be submitted monthly via electronic information transfer or paper copy of case abstracts, in a manner or on forms acceptable to the West Virginia Cancer Registry.
4.3.c. If the health care facility fails to report in a format prescribed by the commissioner, authorized West Virginia Cancer Registry personnel may enter the health care facility, access the information and report it in the appropriate format. In these cases the bureau for public health shall assess the health care facility a service fee for accessing and reporting the information. In accordance with WV Code §16-1-11(a) and this rule, the fee collected shall be deposited into the health services fund. The fee shall be based upon the fair market value of the services. The health care facility shall pay the bureau within sixty days of assessment of the fee.
4.4. Health care facilities shall provide authorized West Virginia Cancer Registry personnel access to all medical records which would identify cases of cancer or establish characteristics of cancer to collect the required information on reportable cases of cancer for the purposes of assuring the accuracy and completeness of reported data. Registry staff shall schedule access at reasonable times convenient to the health care facility and registry staff. The West Virginia Cancer Registry staff shall notify the health care facility a minimum of thirty days in advance of its need to access medical records to allow for the health care facility to prepare records for review.
4.5. The West Virginia Cancer Registry shall collect standardized data usable for research purposes.
W. Va. Code R. § 64-68-5 Confidentiality; Disclosure
5.1. No person who obtains information protected by the provisions of WV Code §16-5A-2a and this rule may disclose confidential information to any other person except in strict compliance with WV Code §16-5A-2a and this rule.
5.2. Any person who obtains information protected by the provisions of WV Code §16-5A-2a and this rule shall sign a statement that he or she fully understands and will maintain the confidentiality of the information.
5.3. The West Virginia Cancer Registry may release information which identifies a specific patient to the reporting source which originally reported the cancer case.
5.4. The West Virginia Cancer Registry may release information which identifies a specific patient whose address at the time of diagnosis was outside West Virginia to the central cancer registry in the state where the patient resides. The West Virginia Cancer Registry shall release the information only to central cancer registries in states which have confidentiality standards equivalent to those of West Virginia and which establish reciprocal reporting with West Virginia. The West Virginia Cancer Registry shall have a written agreement with other state cancer registries to which it releases information which specifically addresses provisions for maintaining confidentiality.
5.5. The West Virginia Cancer Registry may release case data to cancer researchers for the purposes of cancer prevention, control and research.
5.5.a. Identifying data may be released for research purposes provided:
5.5.a.1. The researcher supplies the West Virginia Cancer Registry with written consent of the patient, physician, health care provider or personal representative of a deceased case, whichever is appropriate; and
5.5.a.2. The researcher assures that the data received from the West Virginia Cancer Registry will be maintained by the researcher with the same level of confidentiality as that maintained by the West Virginia Cancer Registry.
5.5.b. In accordance with the provisions of the Legislative rule on Reportable Diseases, Events and Conditions, 64CSR7, the West Virginia Cancer Registry may contact individual patients who have cancer and are in the West Virginia Cancer Registry for the purpose of patient recruitment for a research study.
5.5.c. The West Virginia Cancer Registry may provide data linkages to appropriate researchers or institutions to allow for the meaningful use of cancer registry data for a fee. The fee shall be eight hundred dollars ($800.00) per linkage and a fifty dollar ($50.00) per hour assessment for the bureau employee staff time associated with completing the data linkage. The fee shall be assessed and collected by the Office of Epidemiology and Prevention Services of the bureau and shall be deposited into the health services fund.
W. Va. Code R. § 64-68-6 Violations and Sanctions
Failure to comply with this rule as required subjects a person to the criminal penalties prescribed in WV Code §16-1-18.
W. Va. Code R. § 64-68-7 Administrative Due Process
Those persons adversely affected by the enforcement of this rule desiring a contested case hearing to determine any rights, duties, interests or privileges shall do so in a manner prescribed in the bureau for public health Rules of Procedure for Contested Case Hearings and Declaratory Rulings, 64CSR1.
64CSR68
64CSR68
Series 69 Breast And Cervical Cancer Diagnostic And Treatment Fund
W. Va. Code R. § 64-69-1 General
1.1. Scope. -- This rule establishes the procedures and the process for providing financial assistance to medically and financially eligible patients for certain diagnostic and treatment services for breast cancer, cervical cancer or precancerous cervical lesions. Funds appropriated by the Legislature, any funds allocated by the federal government, and any other sums designated for deposit in the fund from any other public or private source for medical assistance are to be distributed from the breast and cervical cancer diagnostic and treatment fund established by the State Legislature. In selecting services to be covered, the advisory committee has attempted to maximize the coverage of early diagnostic and treatments procedures in order to maximize the efficient use of funds. The advisory committee believes that in many instances if more extensive procedures are needed in later stages of diagnosis and treatment, patients are likely to qualify for coverage under Medicaid.
1.2. Authority. -- W. Va. Code '16-33-8.
1.3. Filing Date. -- April 3, 1998.
1.4. Effective Date. -- May 4, 1998.
1.5. Applicability. -- This rule applies to providers of, applicants for, and recipients of breast and cervical cancer diagnostic and treatment services.
1.6. Enforcement. -- This rule is administered by the office of maternal and child health within the bureau of public health of the department of health and human resources.
W. Va. Code R. § 64-69-2 Definitions
2.1. Advisory Committee. -- The medical advisory committee to the breast and cervical cancer detection and education program coalition.
2.2. Approved Procedure. -- A medical procedure that has been selected by the medical advisory committee to be paid for by the fund.
2.3. Bureau. -- The state bureau for public health of the department of health and human resources.
2.4. Federal Poverty Level. -- The prevailing national poverty income guidelines established by the federal government and published in the Federal Register.
2.5. Fund. -- The breast and cervical cancer diagnostic and treatment fund.
2.6. Provider. -- A physician, hospital or laboratory currently licensed and operating or practicing in this state.
W. Va. Code R. § 64-69-3 Confidentiality
3.1. No person who obtains information protected by the provisions of W. Va. Code '16-5A-2a and this rule may disclose confidential information to any other person except in strict compliance with W. Va. Code '16-5A-2a, this rule and any other applicable federal or state law, rule or regulation.
3.2. Any person who obtains information protected by the provisions of W. Va.Code Code '16-5A-2a and this rule shall sign a statement that he or she fully understands those provisions and will maintain the confidentiality of the information.
W. Va. Code R. § 64-69-4 Eligibility
4.1. To be eligible financially for services under the fund, a patient=s income shall be at or below two hundred percent (200%) of the federal poverty level. No patient who is covered by medical insurance, Medicaid or Medicare is financially eligible for participation in the fund.
4.2. To be eligible medically for diagnostic services under the fund, a patient shall have a condition strongly suspicious of cancer which requires diagnostic services to confirm the preliminary diagnosis. The bureau shall authorize only those services determined by the advisory committee as established in this rule to be medically necessary to confirm a preliminary diagnosis.
4.3. To be eligible medically for treatment services under the fund, the patient shall have a positive pathology report.
W. Va. Code R. § 64-69-5 Procedures Covered
5.1. Breast cancer related procedures covered by the fund include, but are not limited to:
5.1.a. Breast biopsy-needle core;
5.1.b. Breast biopsy-incisional;
5.1.c. Breast biopsy-excisional;
5.1.d. Breast biopsy-identified by radiological marker;
5.1.d.1. Each additional lesion;
5.1.e. Pre-op placement of needle localization wire;
5.1.f. Breast biopsy-stereotactic localization;
5.1.g. Needle localization-radiologic supervision/interpretation;
5.1.h. Radiological examination, surgical specimen;
5.1.i. Ultrasound guided biopsy;
5.1.j. Lab-needle biopsy;
5.1.k. Lab-surgical pathology breast tissue biopsy;
5.1.l. Stereotactic biopsy supplies;
5.1.m. Follow-up after procedure-outpatient;
5.1.n. Follow-up consultation-post-op outpatient; and
5.1.o. General anesthesia.
5.2. Cervical cancer related procedures covered by the fund include, but are not limited to:
5.2.a. Loop electrode excision procedure;
5.2.b. Biopsy or local excision of lesion;
5.2.c. Endocervical curettage;
5.2.d. Cryocautery of the cervix;
5.2.e. Laser surgery of the cervix;
5.2.f. Conization of the cervix;
5.2.g. Dilation and curettage-diagnostic and/or therapeutic;
5.2.h. Lab-cervical biopsy;
5.2.i. Follow-up after procedure-outpatient; and
5.2.j. General anesthesia.
W. Va. Code R. § 64-69-6 Review and Authorization
6.1. The medical advisory committee shall entrust the day to day review and authorization for payment as authorized by this rule to the director of the breast and cervical cancer screening program of the office of office of maternal and child health within the bureau.
W. Va. Code R. § 64-69-7 Application and Process
7.1. The provider shall apply for and receive reimbursement from the fund on behalf of the patient. The provider shall:
7.1.a. Refer to the list of covered procedures set forth in Section 5 of this rule, and may, if needed, consult with the director of the breast and cervical cancer screening program to determine if the procedure to be performed is covered;
7.1.b. Complete the fund application form approved by and available from the division and submit it to the director of the breast and cervical cancer screening program for approval, except as specified in subsection 7.2 of this rule;
7.1.c. Provide the services; and
7.1.d. Submit an invoice to the director of the breast and cervical cancer screening program listing procedures and CPT codes, accompanied by a pathology report when appropriate, within ninety (90) days of the date the service was provided.
7.2. The provider shall complete only the medical eligibility section of the application for patients who have already been screened and determined to meet the financial eligibility criteria through the breast and cervical cancer screening program.
7.3. The division shall use the current rate established by Medicare to determine the amount of payment.
7.4. Providers performing procedures to be covered by the fund shall accept the Medicare-determined payment amount as full payment.
W. Va. Code R. § 64-69-8 Administrative Due Process
Those persons adversely affected by the enforcement of this rule desiring a contested case hearing to determine any rights, duties, interests or privileges shall do so as prescribed in the division of health=s administrative rule, Rules of Procedure for Contested Case Hearings and Declaratory Rulings, 64 CSR 1.
The Department of Health and Human Resources (DHHR) was created by the Legislature's reorganization of the executive branch of State government in 1989. The Department of Public Health was renamed the Division of Health and made a part of the DHHR (W. Va. Code ' 5F-1-1 et seq.). Administratively within the DHHR the Bureau for Public Health through its Commissioner carries out the public health function of the Division of Health.
64CSR69
Series 70 Primary Care Support Program
W. Va. Code R. § 64-70-1 General
1.1. Scope. This rule establishes processes for the administration of the primary care support program created within the Bureau for Public Health.
1.2. Authority. -- W. Va. Code §16-2H-2(d).
1.3. Filing Date. -- May 8, 2025.
1.4. Effective Date. -- May 8, 2025.
1.5. Sunset Provision. -- This rule shall terminate and have no further force and effect on August 1, 2030.
W. Va. Code R. § 64-70-2 Definitions
2.1. “Bureau for Medical Services” or “BMS” means the division within the West Virginia Department of Human Services that is responsible for administration of the Medicaid program in West Virginia.
2.2. “Bureau for Public Health” or “BPH” means the division within the West Virginia Department of Health that carries out public health functions.
2.3. “Director” means the commissioner of BPH or his or her lawful designee.
2.4. “Community-Based Board of Directors” means a board of directors composed of members who reside within the service area of the primary care center under consideration.
2.5. “Federally Qualified Health Center (FQHC)” means an entity that meets the United States Health Care Financing Administration definition of a federally qualified health center promulgated at 42 CFR § 405.2401.
2.6. “Federally Qualified Health Center Look-alike” or “Look-alike” means a public or not-for-profit health center that meets the eligibility requirements to receive a federal public health services grant under the “Public Health Services Act,” 42 U.S.C. 254b, but does not receive grant funding.
2.7. “Nonprofit” means an entity registered with the Secretary of State as a nonprofit organization and is recognized as such for tax purposes or having filed an application for such designation.
2.8. “Primary Care Center” means an organization which has as its purpose the delivery of primary care services.
2.9. “Primary Care Service” means a health care service, including medical care, that emphasizes first-contact patient care and assumes overall and ongoing responsibility for the patient in both health maintenance and treatment of illness. Primary care involves a unique interaction between the patient and primary care physician or a multi-disciplinary team under the supervision of a physician or both. The appropriate use of referrals and community resources is an important part of effective primary care. The care is generally provided by a physician but may be provided by other members of a multi-disciplinary team such as registered nurses, nurse practitioners, physician assistants, and nurse-midwives. The purpose of this interaction is to achieve comprehensive coordination of health care including educational, behavioral, biological, and social aspects of care. It is a patient care-oriented approach which emphasizes the continuity of care over the full spectrum of health services. It begins with patient assessment, wellness, and prevention through medical management, lifestyle modification, and health education. The primary care provider is the patient’s advocate through the complex system of health care delivery.
2.10. “Program” means the Primary Care Support Program within BPH.
2.11. “Related Organization” means any organization, whether publicly owned, nonprofit tax-exempt, or for profit, related to a primary care center through common membership, governing bodies, trustees, officers, stock ownership, family members, partners, or limited partners, or a subsidiary, foundation, related corporation, joint venture, or other similar organization, if such similar organization controls or is controlled by the primary care center through contracts, or other legal documents that allow the organization the authority to direct any of the primary care center’s activities, management, or policies. A subsidiary, foundation, related corporation, joint venture, or other similar organization shall also be considered a "related organization" in the following situations:
2.11.1. The subsidiary, foundation, related corporation, joint venture, or other similar organization has solicited funds in the name of the primary care center with the express or implied approval of the primary care center, and any portion of the funds were intended by the contributor, or otherwise required to be used, for the benefit of the primary care center;
2.11.2. The primary care center has transferred or may transfer resources to the subsidiary, foundation, related corporation, joint venture, or other similar organization;
2.11.3. The subsidiary, foundation, related corporation, joint venture, or other similar organization has transferred or may transfer resources to the primary care center, or any of the primary care center’s resources are held for the benefit of the subsidiary, foundation, related corporation, joint venture, or other similar organization;
2.11.4. The primary care center has assigned certain of its functions to the subsidiary, foundation, related corporation, joint venture, or other similar organization, that is operating primarily for the benefit of the primary care center;
2.11.5. The subsidiary, foundation, related corporation, joint venture, or other similar organization is wholly owned or was created by the primary care center, and the primary care center receives any of the profits of the subsidiary, foundation, related corporation, joint venture, or other similar organization; or
2.11.6. The primary care center is wholly owned or was created by the foundation, related corporation, joint venture, or other similar organization, and the foundation, related corporation, joint venture, or other similar organization receives any of the revenues of the primary care center.
2.12. “Rural Health Clinic” or “RHC” means a facility that:
2.12.1. Has been determined by the Secretary of the United States Department of Health and Human Services to meet the requirements of section 1861(aa)(2) of the United States Social Security Act, Title 42 U.S.C. § 1395x(aa)(2), and for certification for participation in Medicare; and
2.12.2. Has filed an agreement with the Secretary of the United States Department of Health and Human Services in order to provide rural health clinic services under Medicare. (See 42 CFR Part 405, Subpart X and 42 CFR Part 491 for additional information.)
2.13. “Secretary” means the Secretary of the Department of Health.
2.14. “Sliding Fee Scale” means a set of varying amounts (percentages of a maximum fee) to be charged for services to individuals receiving varying levels of income.
2.15. “Uncompensated Primary Care Costs” means a primary care center’s financial deficit created when the primary care center’s revenues do not offset expenses incurred in rendering primary care services.
W. Va. Code R. § 64-70-3 Primary Care Support Appropriation
3.1. Upon the enactment and approval of an annual state budget that includes an appropriation dedicated to “primary care support,” the Secretary shall designate a portion of such fund for transfer to the BMS medical services fund for use in the state Medicaid program; such amount so designated shall be in an amount that the Secretary, in his or her discretion and based on an assessment of the state’s overall primary care needs, determines would be best dedicated to provide additional funding.
3.2. The portion of the annual appropriation remaining in the primary care support fund after the transfer to the BMS medical services fund in accordance with subsection 3.1 of this rule shall be disbursed by the director in accordance with the provisions of this rule, and may be expended to support activities related to rural and primary care and include, but not limited to, the following: Offset of costs of uncompensated care provided by primary care centers; technical support to and educational collaboration with the primary care centers; required cost-sharing and matching of key federal grants; and personnel and related administrative costs incurred by BPH in its operation of the program.
W. Va. Code R. § 64-70-4 Application Procedures
4.1. Applications for grants to offset the cost of providing uncompensated primary care services shall be submitted by May 1 of each year, unless another date is announced by the director, and shall be on forms approved by the director. The director may request appropriate documentation or clarification of the application from the applicant.
W. Va. Code R. § 64-70-5 Eligibility
5.1. In order to be eligible for a grant, an entity shall provide evidence that it:
5.1.1. Has been in existence for a period of at least two years or has requested certificate of need review at least two years prior to the date of the application;
5.1.2. Is incorporated under the laws of West Virginia as a private nonprofit corporation;
5.1.3. Has a community-based board of directors;
5.1.4. If it derives revenues, at least 80 percent of the revenues, excluding those funds from charitable foundations and state and federal grants, are derived from the provision of primary care services;
5.1.5. Provides full disclosure regarding all related organizations and their financial relationship to the primary care center;
5.1.6. Provides primary care services to all patients regardless of the patients’ ability to pay; and
5.1.7. Uses generally accepted accounting principles.
W. Va. Code R. § 64-70-6 Application Reviews and Grant Awards
6.1. Review of grant applications to offset costs of uncompensated care consists of the analysis and evaluation of the following information:
6.1.1. The organization’s most recent audit as described in section 7 of this rule;
6.1.2. A 12-month period summary of revenues and expenses;
6.1.3. Projected grant year revenues and expenses;
6.1.4. Number of actual and projected patients and patient encounters;
6.1.5. Actual and projected collections;
6.1.6. Services provided;
6.1.7. Indebtedness;
6.1.8. Notice of federal grant awards;
6.1.9. Verification of quality assurance;
6.1.10. Evidence of historical receipt of funds as of July 1, 2019; and
6.1.11. Any other information judged necessary by the director to evaluate the organization’s need for state funding.
6.2. The director shall base awards of grant funds on the grant application review and the availability of funds.
6.3. The grantee shall use grant funds only to support the delivery of uncompensated health care services.
6.4. The grantee shall not divert grant funds to any related or other organization.
6.5. The applicant will be notified in writing within 30 days of approval or denial of the grant. Approval or disapproval will be determined by the director, after recommendations have been made by the program staff.
6.6. The director may deny or revoke a grant, or take other available actions, if an applicant, a grantee, or an officer or principal owner of the applicant or grantee has been determined by an appropriate administrative agency or court to be in violation of any applicable federal, state, or local law, rule, or ordinance related to the provision of primary care services by the applicant or grantee.
W. Va. Code R. § 64-70-7 Audits
7.1. A primary care center that has received a grant under this rule shall arrange to have an audit of its total entity for its annual fiscal period in accordance with 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles and Audit Requirements for Federal Awards and in accordance with W. Va. Code §12-4-14. The primary care center shall furnish the director with two copies of the audit report within 120 days of the end of the primary care center’s annual fiscal (audit) period. All questioned or disallowed costs identified in the audit that cannot be resolved to the director’s, and if applicable, the appropriate federal granting agency’s satisfaction shall be returned to the director no later than 180 days following the audit period. The primary care center shall retain audit work papers for a minimum of three years from the date of the audit report and shall make the audit work papers available upon request to the director as well as the appropriate federal granting agency.
7.2. In carrying out the requirements of section 7.1 of this rule, the primary care center shall not use the firm that prepares the organization’s financial statements to conduct the annual independent audit. A grantee may request an exemption from the audit requirement from the director. The request shall be written and shall include justification for the exemption. The director may, at his or her discretion, grant the exemption.
W. Va. Code R. § 64-70-8 Administrative Due Process
Those persons adversely affected by the enforcement of this rule desiring a contested case hearing to determine any rights, duties, interests, or privileges shall do so in a manner prescribed in the “Rules of Procedure for Contested Case Hearings and Declaratory Rulings,” 64CSR1.
64CSR70
Series 72 Interstate Compact On Mental Health
W. Va. Code R. § 64-72-1 General
1.1. Scope. -- This legislative rule contains requirements for the proper and expeditious transfer of committed persons between West Virginia and other party states to the interstate compact on mental health. This rule should be read in conjunction with the provisions and definitions in the interstate compact on mental health appearing in W. Va. Code '27-14-1 et seq.
1.2. Authority. -- W. Va. Code '27-14-2.
1.3. Filing Date. -- April 29, 1999.
1.4. Effective Date. -- July 1, 1999.
1.5. Construction. -- This rule shall be liberally construed to effectuate the compact goals of chapter 27 of the W. Va. Code.
W. Va. Code R. § 64-72-2 Application and Enforcement
2.1. Application - This rule applies to the duties and authority of the compact administrator.
2.2. Enforcement - This rule is enforced internally by the secretary of the department of health and human resources or his or her designee.
W. Va. Code R. § 64-72-3 Definitions
3.1. Compact - The interstate compact on mental health appearing in W. Va. Code '27-14-1 et seq. that provides for the proper and expeditious transfer from one state to another of persons who have been committed with mental deficiency or mental illness.
3.2. Compact administrator - The secretary of the department of health and human resources or his or her designee.
3.3. Dangerous or potentially dangerous patient - A person who has escaped from an institution in another state and poses a threat to society by his or her escape.
W. Va. Code R. § 64-72-4 Compact Administrator; Powers and Duties
4.1. The compact administrator shall administer the compact in accordance with W. Va. Code '27-14-1 et seq. and shall be the general coordinator of activities under the compact. The compact administrator shall receive copies of all reports, correspondence, and other documents relating to any patient processed under the compact by this state either in the capacity of sending or receiving state.
4.2. The compact administrator, subject to the approval of the state auditor, may make or arrange for any payments necessary to discharge any financial obligations imposed upon this state by the compact or by any supplementary agreement entered into under the compact.
4.3. The compact administrator is not obligated to receive any patient from another party to the compact.
4.4. The compact administrator shall determine the place most suitable for the patient and may review at any time the placement and make changes in accordance with the best interests of the patient and the state.
4.5. The compact administrator is the only person authorized to issue an order requesting the detention of a dangerous or potentially dangerous patient who has escaped from an institution in another state.
4.5.a. Immediately upon learning that a dangerous or potentially dangerous escaped patient may be in West Virginia, the compact administrator may detain him or her through the issuance of a detention order.
4.5.b. Once identification has been made of an escaped patient, the compact administrator shall arrange to immediately return that individual to the state where he or she escaped. If the escaped patient cannot be immediately returned to the state where he or she escaped, the escaped patient shall be detained at an institution or a secure setting designated by the compact administrator until transfer is possible.
W. Va. Code R. § 64-72-5 Due Process
5.1. When issuing a detention order, the compact administrator shall substantially recite the facts necessary to the validity of the order.
5.2. Before a patient is returned to the state where he or she escaped, the compact administrator shall assure that the patient is informed: of the reason for his or her detention; of his or her right to a hearing to determine identification; and, if the patient decides to challenge the identification, of his or her right to have the representation of counsel provided at state expense.
64CSR72
Series 73 Basic Public Health Service Standards for Local Boards of Health
W. Va. Code R. § 64-73-1 General
1.1 Scope. -- This legislative rule establishes standards for the provision of basic public health services by local boards of health. This legislative rule also establishes a formula for use in distributing State funds to support local boards of health.
1.2 Authority. -- W. Va. Code §16-1-6(b)(9).
1.3. Filing Date. -- April 13, 2026.
1.4. Effective Date. -- July 10, 2026.
1.5. Sunset Provision. -- This rule shall terminate and have no further force or effect on August 1, 2031.
W. Va. Code R. § 64-73-2 Application and Enforcement
2.1. Application -- This rule applies to local boards of health.
2.2. Enforcement -- This rule is enforced by the State Health Officer and the Center for Local Public Health housed within the Bureau for Public Health as set forth in W. Va. Code §16-1-6 (b).
W. Va. Code R. § 64-73-3 Definitions
3.1. Base amount -- The amount of floor funding provided to each county up to the amount required to pay the costs of four full time staff persons, including a nurse, a sanitarian, an administrator and a clerical worker using statewide average salaries for each position plus 30 percent for benefits and 20 percent for overhead.
3.2. Bureau -- Bureau for Public Health in the Department of Health.
3.3. Commissioner -- The Commissioner of the Bureau or his or her designee.
3.4. Consolidation -- A formal combining of two or more local health departments and the combining of their boards of health.
3.5. Department -- The state department of health.
3.6. Fiscal Year -- The 12-month period beginning the first day of July and ending the 30th day of the following June.
3.7. Immediate Jeopardy -- A situation in which entity noncompliance has placed the health and safety of those in its care at risk for serious injury, serious harm, serious impairment, or death.
3.8. Interventions -- The number of interventions per thousand in the county exceeding the average number of total interventions in the state, which may include, but shall not be limited to, total patient encounters, environmental inspections, permits issued and other appropriate quantifiable public health services performed by local health departments.
3.9. Local Board of Health or Board -- A board of health serving one or more counties, one or more municipalities, or a combination thereof.
3.10. Local Health Department -- The staff of the local board of health.
3.11. Local Health Officer -- A physician with a current license to practice medicine in West Virginia or a licensed advanced practice registered nurse who has the ability to independently practice who shall supervise and direct the activities of the local health department services, employees, and facilities who is appointed by the local board of health.
3.12. Need factor -- The relative importance expressed as a mathematical value for each of five health measurement factors described in subsection 8.3. of this rule used to allocate state funds in a fair and equitable manner among local health departments.
3.13. Plan of Correction -- A written description of the actions the local board of health intends to take to correct and prevent the reoccurrence of violations of a rule or policy identified by the Center for Local Public Health during a performance review.
3.14. Population -- The population of a county as determined by the Population Estimates Program of the United States Census Bureau data (www.census.gov).
3.15. Population density -- A calculation derived from the population data and the land area retrieved from the United States Census Bureau.
3.16. Poverty level -- The last full year of data per county as reported in the Small Area Income and Poverty Estimates for West Virginia counties.
3.17. State Aid Funds -- Funds appropriated annually by the legislature to provide financial aid to local boards of health.
W. Va. Code R. § 64-73-4 Operation
4.1 The Bureau shall distribute and monitor state aid funds to the Local Boards of Health in accordance with W. Va. Code §16-1-4, W. Va. Code §16-1-6(b), and this rule.
4.2. Contracts, memoranda, or other forms of agreement between a board and other parties to support the provision of basic public health services shall be in writing unless resources need to be deployed to respond to an imminent and urgent public health threat, and in that case, within 45 days.
4.3. The board shall ensure that any additional non-basic public health services, including primary care and other health services, that are initiated or implemented are well coordinated with basic public health services and are supported by plans that include sources of funding other than state aid.
4.4. The board shall ensure adequate staff to carry out basic public health services and appoint a local health officer and administrator to oversee and maintain continuity of staff to support the provision of basic public health services and daily operations.
4.5. The board shall have liability insurance at least equivalent to that available to local boards through the Board of Risk and Insurance Management, which includes all staff, board members, and contracted services.
4.6. Patient or client care protocols, including standing orders and medical directives, shall be approved annually by the local health officer and available within the local health department.
4.7 The board shall maintain records of necessary licensure, certifications, and/or registration for personnel.
W. Va. Code R. § 64-73-5 Basic public health services standards
5.1. The board shall provide the following basic public health services:
5.1.1. Community health promotion services standards.
5.1.1.a. The board shall target outreach to create and maintain relationships with diverse partners, which may include but is not limited to, health-related and community-based organizations, community groups representing populations experiencing health inequity, private businesses, health care organizations, and government leaders;
5.1.1.b. At least every five years, the board shall conduct or participate in an evaluation of the health needs of the community it serves using generally accepted needs assessment techniques and publicly report the results;
5.1.1.c. Every five years, in collaboration with community partners identified in paragraph 5.1.1.a., the board shall initiate or participate in the mobilization of the community to identify and report publicly the health priorities arising from the health assessment, including the analysis of health disparities and social determinants of health; and
5.1.1.d. The board shall establish an annual plan to address the priority health needs that define a role for the local health department in the programmatic or policy activities.
5.1.2. Communicable and reportable disease services standards.
5.1.2.a. The board shall report, investigate, and control certain diseases and conditions, unusual health events, and clusters or outbreaks of disease through compliance with the requirements of 64CSR7, Reportable Diseases, Events and Conditions and shall provide the following additional services:
5.1.2. a.1. Identify and maintain a current directory of local jurisdiction reporting sources;
5.1.2.a.2. Ensure reporting sources are provided with a 24-hour emergency contact number for reporting disease conditions, unusual health events, and outbreaks of disease;
5.1.2.a.3. Report and investigate within the timeframes for each respective condition in accordance with 64CSR7 and submit for review infectious disease case reports within one month of notification to the Bureau;
5.1.2.a.4. Complete and submit all required outbreak reports to the Bureau within three months of the outbreak closing;
5.1.2.a.5. Ensure appropriate staff maintain entry and access to training resources for the statewide disease surveillance system for investigation of reportable diseases and conditions, as well as ensure staff who leave the local health department are deprovisioned;
5.1.2.a.6. Maintain unexpired laboratory specimen collection supplies to meet routine surveillance and outbreak needs of clinical and environmental specimens for reportable conditions;
5.1.2.a.7. Develop and maintain means to communicate health advisories sent by the Bureau among public health partners in local jurisdictions;
5.1.2.a.8. Assist in the recruitment of an influenza sentinel provider;
5.1.2.a.9. Assure HIV education, counseling, and testing, including anonymous testing, is available for at-risk county residents;
5.1.2.a.10. Provide HIV risk assessment and counseling for clinic populations (e.g., family planning, tuberculosis, sexually transmitted disease);
5.1.2.a.11. Assure that clinical sexually transmitted infections and tuberculosis services such as screening, diagnosis, and treatment, are readily available to all county residents; and
5.1.2.a.12. Implement a mechanism to educate private health care providers on reporting and management of sexually transmitted infections.
5.1.2.b. The board shall investigate and control tuberculosis through compliance with the requirements of 64CSR76, Tuberculosis Testing, Control, Treatment and Commitment, and ensure following additional services:
5.1.2.b.1. Designate a nurse to manage all tuberculosis cases;
5.1.2.b.2. Initiate an epidemiological investigation within three days of notification of active disease or notification that any child has a positive tuberculin skin test reaction, regardless of whether active disease is present;
5.1.2.b.3. Offer screening and necessary follow-up examination to all close contacts of infectious tuberculosis cases;
5.1.2.b.4. Collect appropriate specimens for submission to the Office of Laboratory Services on the initial isolate from all the tuberculosis cases reported in the county, including those diagnosed by private providers;
5.1.2.b.5. Offer recommended tuberculosis preventative therapy to all infected contacts as indicated;
5.1.2.b.6. Assure that healthcare professionals seeing tuberculosis patients have current treatment guidelines and set up coordination between the private provider and the state tuberculosis control program for all active tuberculosis cases.
5.1.2.b.7. Provide directly observed therapy (DOT) for all active tuberculosis cases and provide DOT for latent tuberculosis cases as directed by the state tuberculosis control program; and
5.1.2.b.8. Offer screening services for tuberculosis infections to residents who fall into high-risk groups. Institutions are responsible for their own screening programs.
5.1.3. Environmental health protection standards.
5.1.3.a. The local board shall promote a safe and healthy environment, and maintenance of clean and safe air, water, food, and facilities through a program of routine public health environmental education and control;
5.1.3.b. The board shall administer public health sanitation rules as specified by the State Health Officer with regard to:
5.1.3.b.1. Public drinking water sanitation, W. Va. Code §16-2-11(a)(1)(B);
5.1.3.b.2. Sewer Systems, Sewage Treatment Systems, and Sewage Tank Cleaners, 64CSR9 and Sewage Treatment and Collection System Design Standards, 64CSR47;
5.1.3.b.3. Food Establishments, 64CSR17;
5.1.3.b.4. Child Care Centers, 64CSR21;
5.1.3.b.5. Recreational Water Facilities, 64CSR16;
5.1.3.b.6. General Sanitation, 64CSR18;
5.1.3.b.7. Water Well Regulations, 64CSR19, and Water Well Design Standards, 64CSR46;
5.1.3.b.8. Manufactured Home Communities, 64CSR40;
5.1.3.b.9. Body Piercing Studio Business, 64CSR80;
5.1.3.b.10. Tattoo studio business sanitation, W. Va. Code §16-38-2;
5.1.3.b.11. Nuisances affecting public health, W. Va. Code §16-3-6;
5.1.3.b.12. Local disaster sanitation; and
5.1.3.b.13 Environmental health investigation related to disease control.
5.1.3.c. The board shall report environmental health data electronically in a format or system specified by the Bureau available at https://oehs.wvdhhr.org/phs/public-health-sanitation/.
5.1.4. Immunization services standards.
5.1.4.a. The board of health shall implement a program of immunizations according to the Standards for Pediatric Immunization Practices, as published by the U. S. Centers for Disease Control and Prevention (CDC) found at https://www.cdc.gov/mmwr/pdf/rr/rr4205.pdf and in accordance with the West Virginia Vaccines for Children Program guidelines found at https://oeps.wv.gov/immunizations/Pages/vfc_manual.aspx.
5.1.4.b. The board shall ensure all federally funded or federally supplied vaccines, adult or pediatric, are administered in accordance with guidelines established by the Department of Health Division of Immunization Services Program Guidelines (See https://oeps.wv.gov/immunizations/Pages/default.aspx#provider).
5.1.4.c. All vaccine adverse events should be reported to the Vaccine Adverse Event Reporting System (VAERS) and the West Virginia Poison Control Center.
5.1.5. Threat preparedness standards.
5.1.5.a. The board of health shall implement and maintain a threat preparedness program that ensures the delivery of core public health activities during local or statewide public health emergency response events, or both, and includes the following:
5.1.5.a.1. Maintain a public health all-hazards emergency operations plan that is updated and renewed annually;
5.1.5.a.2. Ensure a continuity of operations plan is in place and can be implemented, including a plan of succession, that is reviewed and updated annually;
5.1.5.a.3. Maintain and implement a process for urgent 24-hour communications with response partners; and
5.1.5.a.4. Conduct operations in accordance with applicable federal incident command principles (See https://training.fema.gov/emiweb/is/icsresource/assets/ics%20review%20document.pdf), including conducting and participating in exercises and the use of “after action reports” (See https://www.fema.gov/sites/default/files/2020-04/Homeland-Security-Exercise-and-Evaluation-Program-Doctrine-2020-Revision-2-2-25.pdf).
W. Va. Code R. § 64-73-6 Reports and Records
6.1. The board shall, in a timely manner, submit written reports and records in compliance with applicable state and federal rules and regulations.
6.2. The board shall develop a data retention policy for medical records, laboratory results, and case reports.
W. Va. Code R. § 64-73-7 Performance-based evaluation
7.1. The Center for Local Public Health shall:
7.1.1. Develop and facilitate bi-directional relationships with local health departments. This bi directional relationship shall include the following objectives:
7.1.1.a. Establish, review, and revise the instrument used to evaluate the provision of basic public health services annually and in accordance with the provisions of this rule;
7.1.1.b. Develop, maintain, and update a tool for conducting an annual assessment and an annual inventory of local public health services.
7.1.1.b.1. The Center for Local Public Health shall perform an annual assessment and inventory of local public health services, or upon complaint or for good cause, of all local health department basic public health services programs and records for conformance with this rule.
7.1.1.b 2. The Center for Local Public Health shall provide a draft report of the findings to the State Health Officer and the local board of health within 15 business days of completion of the review.
7.1.1.b 3. Within 15 business days of receipt of the report, the local board of health shall submit a written plan of correction to the State Health Officer and the appointing authority for the local board of health addressing all deficiencies that are violations of this rule. The plan of correction shall specify:
7.1.1.b.3.A. Any action taken or procedures proposed to correct the deficiencies and prevent their recurrence;
7.1.1.b.3.B. The date of completion of each action taken or to be taken; and
7.1.1.b.3.C. The signature of the local health officer, or his or her designee, or other executive officer of the local board of health.
7.1.1.b.4. The local board of health shall immediately correct all violations that result in immediate jeopardy to the health or safety of any individual.
7.1.1.b.5. The proposed plan of correction shall be approved, modified, or rejected by the State Health Officer within 15 business days. The State Health Officer shall state the reason for modification or rejection of a proposed plan of correction.
7.1.1.b.6. The local board of health shall submit a revised plan of correction to the State Health Officer and the appointing authority for the local board of health within 15 business days of receipt of a rejection by the State Health Officer. The revised plan of correction shall be approved, modified, or rejected by the State Health Officer within 15 business days.
7.1.1.b.7. Informal Dispute Resolution.
7.1.1.b.7.A. Documentation for an informal dispute resolution shall be submitted with, but separate from, the plan of correction for existing deficiencies.
7.1.1.b.7.B. The request for an informal dispute resolution shall be submitted at the time the plan of correction is submitted for existing deficiencies.
7.1.1.b.7.C. The Commissioner shall write a policy and procedures addressing the manner in which an informal dispute resolution shall be conducted.
7.1.1.b.7.D. All written communications during an informal dispute resolution are, and shall remain, confidential.
7.1.1.c. Maintain at least quarterly training curriculum for local boards of health and local health department staff.
7.2. The board shall perform an annual self-assessment, in response to the annual assessment performed by the Center for Local Health, on a form or system provided by the State Health Officer, of all basic public health services to ensure compliance with applicable statutes and rules.
7.3. The board shall design and implement a plan to address areas where compliance with the standards outlined in this Rule are not met.
W. Va. Code R. § 64-73-8 Membership and duties of the West Virginia Public Health Advisory Committee
8.1. The West Virginia Public Health Advisory Committee shall be comprised of the following nine members, appointed by the Commissioner as follows:
8.1.1. The West Virginia Association of Local Health Departments shall submit to the Commissioner a list of up to eight names, which are to include administrators and health officers, of which five in total shall be appointed.
8.1.2. The County Commissioner’s Association of West Virginia and the West Virginia Association of Counties shall each submit to the Commissioner a list of five names\, of which three in total will be selected.
8.1.3 The President of the WVALHD.
8.2. The members of the Committee shall vote on a Chairperson for the Advisory Committee who shall serve a two-year term and be responsible for submitting all meeting notes to the Bureau.
8.3. Committee members shall serve two-year terms, not to exceed four consecutive terms.
8.4. The Committee shall:
8.4.1. Act in an advisory capacity to the Commissioner.
8.4.2. Collaborate with the Bureau to design and develop tools for assessment of local health board performance.
8.4.3. Provide input on training for local health and state appointees as determined by the Commissioner.
8.4.4. Hold no less than six meetings per year.
W. Va. Code R. § 64-73-9 Formula; Allocation of Funds
9.1. The Commissioner, in consultation with the State Health Officer, shall distribute State funds for basic public health services to local boards of health as directed by the State Legislature, this rule and State law.
9.2. The amount of State funds for basic public health services available for distribution to local boards of health by the formula established by subsection 9.3. of this rule is the amount of funds appropriated by the Legislature for this purpose: Provided, that prior to applying the formula, the Commissioner, in consultation with the State Health Officer, may withhold no more than two percent of the funds, as shown in the appropriate line item in the State budget, for use in emergencies according to the provisions of section 10 of this rule: and, provided, however, that prior to applying the formula, the Commissioner, in consultation with the State Health Officer, shall subtract no more than 4.7 percent of the total funds appropriated by the Legislature to be retained by the Bureau for state support of local boards of health and for the provision of basic public health services.
9.3. The Commissioner, in consultation with the State Health Officer, shall calculate the amount of State funds for basic public health services funds to be distributed to each local board of health according to the following formula:
9.3.1. Step 1: Base Amount: The determination of the base amount of funds per county shall be calculated as follows:
9.3.1.a. 22 percent of the amount of state funds for basic public health services available for distribution to local boards of health;
9.3.1.b. Divide the base amount calculation by 55 to determine the base amount for each county; and
9.3.1.c. The base amount shall not exceed the amount needed to pay for four full time staff; a nurse, a sanitarian, an administrator and a clerical worker, using statewide average salaries for each position, plus 30 percent for benefits and 20 percent for overhead.
9.3.2. Step 2 Poverty: The “need factor” is the percentage of individuals in the county living below the level of income established by the federal government as being in poverty. Poverty is assigned a weight of 40 percent.
9.3.2.a. Coefficients are the percentage of individuals living below the poverty line:
9.3.2.a.1. Less than 110 percent = 0.00;
9.3.2.a.2. 111 – 120 percent = 0.05;
9.3.2.a.3. 121 – 130 percent = 0.10;
9.3.2.a.4. Above 130 percent = 0.15.
9.3.3. Step 3 Health Status: The “need factor” is years of potential life lost in the county. Health status is assigned a weight of 20 percent.
9.3.3.a. Coefficients are the percentage years of potential life lost exceed the state average:
9.3.3.a.1. Less than 110 percent = 0.00;
9.3.3.a.2. 111-120 percent = 0.05;
9.3.3.a.3. 121- 130 percent = 0.10;
9.3.3.a.4. Above 130 percent = 0.15.
9.3.4. Step 4 Population Density: The “need factor” is density of individuals living in the county less than the state average. Population density is assigned a weight of 15 percent.
9.3.4.a. Coefficients are the population density percentage below the state average:
9.3.4.a.1. Less than 77.0 percent = 0.15;
9.3.4.a.2. 77.1 – 82.4 percent = 0.10;
9.3.4.a.3. 82.5 – 90.0 percent = 0.05;
9.3.4.a.4. Above 90.0 percent = 0.00.
9.3.5. Step 5 Interventions: The “need factor” is the number of interventions per thousand in the county exceeding the average number of total interventions in the state. Interventions are assigned a weight of 15 percent.
9.3.5.a. Coefficients are the percentage above the state average:
9.3.5.a.1. Less than 110 percent = 0.00;
9.3.5.a.2. 111- 120 percent = 0.05;
9.3.5.a.3. 121 – 130 percent = 0.10;
9.3.5.a.4. Above 130 percent = 0.15.
9.3.6. Step 6 Consolidation: While not a “need factor” this coefficient is included to encourage counties to merge in the provision of local public health services. The indicator is the number of counties served by the local board of health. Consolidation is assigned a weight of 10 percent;
9.3.6.a. Coefficient is the number of counties in the district served by the local board of health:
9.3.6.a.1. One County = 0.00;
9.3.6.a.2. Two to four counties = 0.15;
9.3.6.a.3. Five or more counties = 0.20.
9.3.7. Step 7: Weighted population calculation: The weighted population for each local board of health is determined by:
9.3.7.a. Multiplying each coefficient from steps 2 through 6 by the factor weight for that coefficient;
9.3.7.b. Adding the results for each calculation in paragraph 9.3.7.a. of this subdivision to the number one;
9.3.7.c. Multiply the number of people in the county by the result of paragraph 9.3.7.b. of this subdivision to obtain the weighted population of the county.
9.3.8. Step 8: Per Capita Distribution: Per capita distribution is determined by;
9.3.8.a. Subtracting the total base amount allocation from the funds available for distribution;
9.3.8.b. Then dividing the weighted population of each county into the amount remaining to determine the per capita distribution for each local board of health.
9.3.9. Step 9: Performance-based Standards Withholding: Withholding of funding for basic public health services shall be based upon noncompliance with performance-based standards.
9.3.9.a. The Commissioner, in consultation with the State Health Officer, shall assign each local board of health a coefficient of 0-5 based upon an analysis of each local health department’s annual assessment performed by the Center for Local Health.
9.3.9.a.1. Local boards of health whose annual assessment indicates that compliance with all five public health services standards has been met shall be assigned a coefficient of 5.
9.3.9.a.2. Local boards of health whose annual assessment indicates that compliance with four out of five public health services standards has been met shall be assigned a coefficient of 4.
9.3.9.a.3. Local boards of health whose annual assessment indicates that compliance with three out of five public health services standards has been met shall be assigned a coefficient of 3.
9.3.9.a.4. Local boards of health whose annual assessment indicates that compliance with two out of five public health services standards has been met shall be assigned a coefficient of 2.
9.3.9.a.5. Local boards of health whose annual assessment indicates that compliance with one out of five public health services standards has been met shall be assigned a coefficient of 1.
9.3.9.a.6. Local boards of health whose annual assessment indicates that compliance with none of the five public health services standards has been met shall be assigned a coefficient of 0.
9.3.9.a.7. Tier 1: Local boards of health with an assigned coefficient of 5 shall receive no withholding of funding; Tier 2: Local boards of health with an assigned coefficient of 3 or 4 shall have 10 percent of the total funds eligible for distribution to those local boards of health withheld; Tier 3: Local boards of health with an assigned coefficient of 0, 1, or 2 shall have 25 percent of the total funds eligible for distribution to those local boards of health withheld.
9.3.9.a.8. Local boards of health that have had a percentage of funding withheld based upon the results of their annual self-assessment shall be eligible for reevaluation no later than May 1 of the current fiscal year in accordance with an approved written plan of correction. Local boards of health that successfully correct all identified deficiencies shall be reassigned a coefficient of 5 and shall receive the remaining balance of eligible funding; local boards of health with an initial coefficient assignment of 0, 1, or 2 that, as a result of implementation of an approved written plan of correction, successfully comply with either three or four out of five public health services standards shall be reassigned a coefficient of either 3 or 4, respectively, and shall receive an additional 15 percent of the total funds eligible for distribution. Withheld funds that remain undistributed shall revert to the emergency fund established in subsection 8.2. of this rule.
9.4. In performing the calculations described in subsection 9.3. of this rule, the Commissioner, in consultation with the State Health Officer, shall use the most recent federal, state, and county population data available.
9.5. The Commissioner, in consultation with the State Health Officer, shall complete the calculations as soon as possible, but not more than two weeks after the budget has passed and the legislative budget instructions are approved.
9.6. After completing the calculations described in subsection 9.3. of this rule, the Commissioner and State Health Officer shall inform local boards of health in writing of their allocation as quickly as possible, but in any case not more than four weeks after the budget has passed and the legislative budget instructions are approved.
9.7. The Commissioner shall cause State funds for basic public health services to be distributed to eligible local boards of health according to standard State procedures beginning the first day of July of the fiscal year for which the funds have been appropriated or as soon as possible after the budget has passed and the legislative budget instructions are approved.
W. Va. Code R. § 64-73-10 Emergency Fund; Establishment; Administration
10.1. The Commissioner, in consultation with the State Health Officer, shall use the emergency fund referenced in subsection 9.2. of this rule to assist local boards of health in need of funds to meet unanticipated financial emergencies. The Commissioner, in consultation with the State Health Officer, may develop an application form for one or more local boards of health to use to apply for emergency funds.
10.2. Funds not obligated for emergency use by the fifteenth day of May shall be distributed by the Commissioner to local boards of health according to the provisions of subsection 9.3. of this rule.
W. Va. Code R. § 64-73-11 Penalties
11.1. In the event that the State Health Officer determines that a local board of health is not in compliance with this rule and upon written notice to the local board of health, the Commissioner, in consultation with the State Health Officer, may withhold state aid funds until such time as the board submits an acceptable plan to correct deficiencies that is approved by the State Health Officer, the board of health and the appointing authority. If such withholding of funds would impair the provision of public health service(s) for a county or service area, the State Health Officer shall arrange for those service(s) to be provided to the county or service area.
W. Va. Code R. § 64-73-12 Administrative Due Process
12.1. Those local boards of health adversely affected by the enforcement of this rule who desire a contested case hearing to determine any rights, duties, interests, or privileges, shall do so in a manner prescribed in 64CSR1, Rules of Procedure for Contested Case Hearings and Declaratory Rulings.
Series 74 Behavioral Health Consumer Rights
W. Va. Code R. § 64-74-1 General
1.1. Scope. -- This legislative rule establishes personal rights of individuals with behavioral health needs.
1.2. Authority. -- W. Va. Code ' 27-5-9(g).
1.3. Filing Date. -- April 13, 2000.
1.4. Effective Date. -- July 1, 2000.
1.5. Construction. -- This rule shall be liberally construed to effectuate the rehabilitative goals of Chapter 27 of the West Virginia Code, consistent with the protection of consumer rights and dignity.
1.6. Applicability. -- This rule applies to individuals with behavioral health needs.
W. Va. Code R. § 64-74-2 Definitions
2.1. Abuse. B
2.1.a. Physical Abuse. -- Any act or failure to act by an employee of a behavioral health service that was knowingly, recklessly, or intentionally performed, or that was failed to be performed, and that caused, or may have caused, injury or death to an individual, including, but not limited to:
2.1.a.1. The rape or sexual assault of an individual;
2.1.a.2. The striking of an individual;
2.1.a.3. The use of excessive force when placing an individual in bodily restraints; and
2.1.a.4. The use of physical or chemical restraints that is not in compliance with federal or State law.
2.1.b. Verbal Abuse. -- Means any use of oral, written ore gestured language by which abuse occurs. This includes demeaning and derogatory terms to describe persons with disabilities. Verbal abuse includes, but is not limited to:
2.1.b.1. Yelling or using demeaning, derogatory, vulgar, profane or threatening language;
2.1.b.2. Threatening tones in speaking;
2.1.b.3. Teasing, pestering, molesting, deriding, harassing, mimicking or humiliating a consumer in any way; or
2.1.b.4. Making sexual innuendo.
2.2. Advance Psychiatric Directive. -- Any instruction written and signed by a consumer, describing preferences in health care written when the consumer is competent and psychiatrically stable and implemented when the consumer is not able to make informed decisions in the absence of an advance psychiatric directive.
2.3. Behavioral Health. -- Mental health, developmental disabilities, or substance abuse.
2.4. Behavioral Health Service. -- An inpatient, residential or outpatient service for the care and treatment of individuals with mental illness, developmental disabilities or substance abuse.
2.5. Consumer. B An individual receiving treatment or services in or from a behavioral health service.
2.6. Individualized Program Plan (IPP). -- A master behavioral health treatment plan which is a written, individualized plan specifically tailored to individual needs, including a complete, thorough review of the consumer=s strengths, weaknesses, response to initial interventions and prognosis for resolution of acute symptoms, and other components as indicated in this rule.
2.7. Legal Representative. B A person or agency with legal authority to exercise some degree of control over a consumer=s affairs; namely, one of the following that is the most appropriate to the decision to be made:
2.7.a. A conservator, temporary conservator or limited conservator appointed pursuant to the West Virginia Legal Guardianship and Conservatorship Act, W. Va. Code '44A-1-1 et seq., within the limits set by the order;
2.7.b. A guardian, temporary guardian or limited guardian appointed pursuant to the West Virginia Guardianship and Conservatorship Act, W. Va. Code '44A-1-1 et seq., within the limits set by the order;
2.7.c. An individual appointed as committee or guardian prior to June 9, 1994, within the limits set by the appointing order and W. Va. Code '44A-1-2(d);
2.7.d. A person having a medical power of attorney pursuant to the West Virginia Medical Power of Attorney Act, W. Va. Code '16-30A-1 et seq., within the limits set by the law and the appointment;
2.7.e. A representative payee under the U.S. Social Security Act, Title 42 US Code '301 et seq., within the limits of the payee's legal authority;
2.7.f. A surrogate decision-maker appointed pursuant to the West Virginia Health Care Surrogate Act, W. Va. Code '16-30B-1 et seq., or the West Virginia Do Not Resuscitate Act, '16-30C-1 et seq., within the limits set by the appointment;
2.7.g. An individual having a durable power of attorney pursuant to W. Va. Code '39-4-1, or a power of attorney under common law, within the limits of the appointment;
2.7.h. An individual identified pursuant to W. Va. Code '16-3C-4 to grant consent for HIV-related testing and for the authorization of the release of test results;
2.7.i. A parent or guardian of a minor; or
2.7.j. An individual lawfully appointed in a similar or like relationship of responsibility for a consumer under the laws of this State, or another legal jurisdiction, within the limits of the applicable law.
2.8. Mechanical Supports. -- Devices used to support an individual=s proper body position or alignment.
2.9. Neglect. -- A negligent act or a pattern of actions or events that caused or may have caused injury or death to a consumer, or that placed a consumer at risk of injury or death, that was committed by an individual responsible for providing services in a behavioral health service. Neglect includes, but is not limited to:
2.9.a. A pattern of failure to establish or carry out a consumer=s individualized program plan or treatment plan that placed or may have placed a consumer at risk of injury of death;
2.9.b. A pattern of failure to provide adequate nutrition, clothing, or health care;
2.9.c. Failure to provide a safe environment; and
2.9.d. Failure to maintain sufficient, appropriately trained staff.
2.10. Restraint. B A temporary behavior control intervention.
2.10.a. Chemical Restraint. -- The use of medication as a behavior control mechanism to substitute for seclusion or other restraint.
2.10.b. Physical Restraint. -- Any manual method or physical or mechanical device that the individual cannot remove easily, and that restricts the free movement of, normal functioning of, or normal access to a portion or portions of a consumer=s body. Examples of manual methods include therapeutic or basket holds and prone or supine containment. Examples of mechanical devices include arm splints, posey mittens, helmets and straight jackets. Excluded are physical guidance, prompting techniques of brief duration, and mechanical supports.
2.11. Seclusion. -- The placement of a consumer alone in a room or enclosed space with closed doors that a consumer cannot open from inside.
2.12. Secretary. -- The Secretary of the West Virginia Department of Health and Human Resources or his or her designee.
2.13. Treatment Plan. -- Means a written design based on the assessment of a consumer=s needs and strengths that identifies problems, sets client-centered goals and objectives and describes all services, programs and activities currently required to support the achievement of the goals and objectives.
W. Va. Code R. § 64-74-3 Applicability to Other Standards
When an individual receives care or treatment from a behavioral health service, state and federal requirements, accreditation standards applicable to the behavioral health service and the standards set forth in this rule apply. If there is a conflict between those requirements, accreditation standards and the standards specified in this rule, the more stringent standard applies, unless the federal standard must be met for the purposes of Medicare or Medicaid participation, then the federal standard prevails. Behavioral health service providers accredited by a national accreditation agency are deemed to be in compliance with this rule.
W. Va. Code R. § 64-74-4 General Rights
4.1. A consumer with behavioral health needs has the following general rights:
4.1.a. The right not to be discriminated against because of the receipt of behavioral health services.
4.1.b. The right to exercise his or her civil rights, except as abrogated by court order or for the reasons provided in this rule;
4.1.c. The right to be informed of these rules and, if an inpatient in a behavioral health service, the right to be given a copy of them;
4.1.d. The right of a consumer, who resides in congregate living arranged for by a behavioral health service provider, to be housed with other consumers of similar age and need unless otherwise specified in the consumer=s individualized program plan or treatment plan;
4.1.e. The right to privacy and the right to move about freely, unless his or her safety or the safety of others is threatened;
4.1.f. The right not to be deprived of any right as punishment or for clinical reasons, except when an incident occurs related to the exercise of a right, the right may be deprived for clinical reasons, but only for as long as is necessary to permit correction of a situation; and
4.1.g. The right of a consumer receiving care and treatment to receive it in accordance with accepted behavioral health and medical practice standards.
W. Va. Code R. § 64-74-5 Advance Psychiatric Directive Right
5.1. A consumer with psychiatric or mental health needs has a right to an advance psychiatric directive prepared at a time when the individual has not been adjudged to be incompetent. Any advance psychiatric directive written and signed by a consumer may be withdrawn at any time verbally or in writing.
5.2. A consumer has the right to be informed by a behavioral health service of the availability and applicability of an advance psychiatric directive and to receive education and assistance from the behavioral health service in preparing such a document.
5.3. A consumer has the right to refuse to create an advance psychiatric directive.
5.4. A consumer with an advance psychiatric directive has the right to have it entered into his or her clinical record at the behavioral health service at which he or she is receiving or may receive care or treatment;
5.5. An advance psychiatric directive shall be honored unless:
5.5.a. It is withdrawn verbally or in writing by a consumer;
5.5.b. The behavioral health service lacks sufficient resources;
5.5.c. A professional staff member of the behavioral health service believes that the directive would endanger the consumer=s life or be dangerous to others.
5.6. A consumer has the right to be informed of the behavioral health service=s reason for not honoring his or her advance psychiatric directive.
5.7. Nothing in this section should be interpreted to prevent any individual with behavioral health needs from entering into an advance directive related to preferences in health care or conduct of business.
W. Va. Code R. § 64-74-6 Informed Consent Right
6.1. In order for a consumer to give informed consent for care or treatment, a behavioral health service shall inform him or her of the following:
6.1.a. The rights provided under this rule;
6.1.b. The nature of his or her condition and the treatment proposed;
6.1.c. Any reasonable alternative treatments available;
6.1.d. That consent for any part of treatment may be withdrawn at any time in writing or verbally to a member of the treatment staff. Revocation of consent shall be documented on the consent form, and further treatment shall not be provided except as authorized in an emergency;
6.1.e. The reason for taking a proposed medication, including the likelihood of the consumer's condition improving or not improving without the proposed medication;
6.1.f. The type, dosage, including the use of PRN (as needed) orders, the method of administration (oral or injection), and the duration of taking the proposed medication; and
6.1.g. The common side effects, any side effects probable with the particular consumer, and additional side effects that may occur when taking the proposed medication longer than three (3) months.
6.2. In the absence of written consent, if treatment is provided to a consumer, he or she has the right to documentation of the precipitating causes for providing the treatment.
6.3. The procedures outlined in this section shall not apply to those individuals who:
6.3.a. Need life-saving medication for chronic medical conditions, such as diabetes or heart disease; or
6.3.b. Have been taking medications prior to admission and have not refused to continue the medication, even though they may not be able to give informed consent.
W. Va. Code R. § 64-74-7 Right to Treatment
7.1. A consumer has the right to treatment in the least restrictive setting possible.
7.2. A consumer has the right to treatment that is provided humanely in an environment that affords them full protection of their rights.
7.3. A consumer has the right to treatment by trained and competent personnel capable of implementing the consumer=s individualized program plan or treatment plan.
7.4. A consumer has the right to periodic evaluations related to his or her needs no less frequently than every one hundred eighty (180) days while an active consumer of a behavioral health service.
7.5. A consumer has the right to treatment based on diagnosis and assessment of their needs.
7.6. A consumer has the right to treatment based on a treatment plan that identifies immediate needs and interventions and responsibility for implementing the plan.
7.7. A consumer has the right to have treatment plans updated every ninety (90) days or as his or her needs change.
7.8. A consumer has the right to participate in the development of his or her individualized program plan or treatment plan and any revisions.
7.9. A consumer has the right to have a copy of his or her individualized program plan or treatment plan.
7.10. A consumer has the right to have present at any treatment planning or discharge planning meeting representatives of all disciplines providing treatment to the consumer and any other individual, including the consumer=s case manager and family members.
7.11. A consumer has the right to have recorded all treatments administered.
7.12. A consumer who resides in an inpatient behavioral health service for more than fourteen (14) days has the right to outdoor exercise and activity programming conforming with the Division of Health rule, ABehavioral Health Client Rights,@ 64CSR59, ''14.1-14.3.
W. Va. Code R. § 64-74-8 Right to Refuse Treatment
8.1. As a participant in the program planning process, a consumer has the right to object to or refuse any aspect of the individualized program plan or treatment plan.
8.2. If informal discussion and negotiation do not resolve differences, a consumer's right to object to or refuse treatment shall be recognized as legitimate, and shall be responded to in accordance with the provisions of the behavioral health service=s consumer grievance procedure.
8.3. A consumer who has refused psychotropic medications or other recommended therapy has the right to have an agreed-upon effective alternative treatment offered, and it shall be provided if the consumer consents and if within the scope of the behavioral health service=s practice.
8.4. A consumer has the right to orally refuse medication or other treatment that overrides prior written consent, except in emergency situations in which it is documented that the absence of medication or other treatment would be harmful to the consumer or others.
W. Va. Code R. § 64-74-9 Right to Refuse Research and Experimental Treatment
9.1. A consumer has the right to refuse to participate in or be subjected to research or experimental treatment. Participation by a consumer shall require voluntary, informed and written consent, and an opportunity for consultation with independent specialists and with his or her legal representative.
W. Va. Code R. § 64-74-10 Rights Regarding Seclusion and Restraints
10.1. A consumer has the right to freedom from seclusion and restraints unless the restraints are documented as clinically necessary and all other less restrictive measures have been exhausted.
10.2. A consumer with a single diagnosis of mental retardation or another developmental disability has the right not to be secluded or restrained, but time-out procedures may be used when they have been developed specifically for the consumer and described in the consumer=s treatment plan.
10.3. A consumer has the right to not have seclusion used as punishment. Seclusion may be used only as an emergency measure to control imminent destructive behavior that is a threat to a consumer or to others.
10.4. A consumer has the right to not have physical restraints used as punishment or as a convenience of staff.
10.5. A consumer has the right for drugs or medications to not be used as punishment, as a convenience of staff, as a substitute for adequate staffing, or as a substitute for an individualized program plan or treatment plan.
W. Va. Code R. § 64-74-11 Right of Confidentiality
11.1. A consumer has the right to have all information about his or her diagnosis and treatment kept confidential.
11.1.a. Confidential information includes, but is not limited to:
11.1.a.1. Information obtained during diagnosis or treatment, including the fact that an individual is or has been a consumer;
11.1.a.2. Information provided by a consumer or his or her family for purposes related to diagnosis or treatment;
11.1.a.3. Information provided by the treatment staff;
11.1.a.4. Diagnoses, opinions or remarks made by treatment staff that relate to a consumer=s treatment;
11.1.a.5. Advice, instructions, or prescriptions issued in the course of diagnosis or treatment; and
11.1.a.6. Any record of a consumer=s treatment.
11.1.b. Confidential information does not include: information which does not identify a consumer; information from which a person acquainted with a consumer would not recognize the consumer; and encoded information from which there is no possible means to identify a consumer.
11.2. A consumer has the right to have information relating to his or her treatment disclosed only:
11.2.a. In a proceeding under W. Va. Code '27-5-4 to disclose the results of an involuntary examination made pursuant to W. Va. Code ''27-5-2 or -3;
11.2.b. In a proceeding under W. Va. Code '27-6A-1 e seq. to disclose the results of an involuntary examination made pursuant to those provisions;
11.2.c. Pursuant to a court order;
11.2.d. To the attorney of the consumer, whether or not in connection with pending judicial proceedings;
11.2.e. To agencies requiring information necessary to make payments to or on behalf of the consumer pursuant to contract or in accordance with law, provided that only such information shall be released to third-party payers as is required to certify that covered services have been provided;
11.2.f. To protect against a clear and substantial danger of imminent injury by a consumer to self or another; and
11.2.g. For internal review purposes of the behavioral health service, to the treatment staff, to other health professionals involved in a consumer=s treatment, on the consumer=s request to anyone designated, or in compliance with applicable federal law, within the meaning of W. Va. Code '27-5-9(e) and/or '27-5-9(3)(i).
11.3. A consumer has the right to be informed about the limits of confidentiality in this rule.
11.4. Consent for Disclosure.
11.4.a. A consent for the disclosure of confidential information shall be in writing and signed by the consumer, or by his or her legal representative. A consumer who signs a consent has the right to a copy of the consent.
11.4.b. A consumer shall not be denied treatment on the basis of refusing to provide consent to disclose confidential information, except when and to the extent disclosure is necessary for treatment, or for the substantiation of a claim for payment for treatment from a source other than the consumer.
W. Va. Code R. § 64-74-12 Right to Unrestricted Communication
12.1. A consumer has the right to unimpeded and private communication by any means with whomever a consumer chooses, except as specified in this rule.
12.2. A consumer=s right to communication, except for that with his or her legal representative, may be restricted or denied if authorized by the treatment staff or the attending physician for a specified time not to exceed thirty (30) days, after which time the restriction may be reviewed and reinstated.
W. Va. Code R. § 64-74-13 Rights Regarding Labor, Earnings, and Funds
13.1. A consumer has the right not to be required to perform uncompensated labor that involves the operation and maintenance of a behavioral health service, but may voluntarily perform it with compensation in accordance with the requirements of relevant State and federal requirements.
13.2. A consumer shall not suffer consequences for refusing to perform uncompensated labor for a behavioral health service.
13.3. A consumer may perform vocational training tasks that do not involve the operation and maintenance of the behavioral health service when the assignment:
13.3.a. Is an integrated part of a consumer=s individualized program plan or treatment plan;
13.3.b. Has been approved as a program activity by the treatment staff; and
13.3.c. Is supervised by a staff member.
13.4. A consumer has unlimited access to his or her funds except as provided by West Virginia law, or by regulations promulgated by the Social Security Administration.
W. Va. Code R. § 64-74-14 Juveniles= Additional Rights
14.1. A consumer under the age of eighteen (18) has the right to be housed separately from emancipated consumers over the age of eighteen (18).
14.2. A consumer under the age of eighteen (18) has the right to an education.
14.3. A consumer under the age of eighteen (18) has the right to appropriate contact and communication with his or her family members and legal representative.
14.4. A consumer under the age of eighteen (18) has the right to be informed about behavior expectations for the protection of others.
14.5. All other rights under this rule apply to consumers under the age of eighteen (18).
W. Va. Code R. § 64-74-15 Right of Advocacy and Grievance Procedure
15.1. A consumer has the right to be informed of and receive a written copy of the behavioral health service grievance procedure.
15.2. A consumer, or another person acting on a consumer=s behalf, has the right to file a grievance with the behavioral health service concerning any alleged violation of the rights afforded by this rule.
15.3. A consumer has the right to discuss a grievance with their professional behavioral health care provider or with an advocate of his or her choosing.
15.4. A consumer has the right to receive a reasonable and timely written decision from the behavioral health service.
15.5. A consumer may, after receipt of the decision or lack of a timely decision on his or her grievance, request a hearing by the Secretary or bring action in circuit court against the behavioral health service.
15.6. A consumer has the right to withdraw his or her grievance at any time.
15.7. The final order by the Secretary after a hearing shall be binding upon the parties, unless appealed in accordance with W. Va. Code ''29A-5 and -6.
15.8. A consumer has the right to pursue other relief even if he or she does not file a grievance.
15.9. A consumer has the right to report any reasonable suspicion of abuse or neglect to civil and criminal authorities in accordance with the applicable adult protective services act (W. Va. Code '9-6-1 et seq.) or child protective services act (W. Va. Code '49-6A-1 et seq.), in addition to usingthe grievance procedure of the behavioral health service.
Behavioral health services should note that the various types of legal representatives do not necessarily have the lawful authority to act on behalf of the resident in all matters that shall require action by a legal representative. For example, a conservator has responsibility for financial affairs, but not personal affairs, such as medical care.
64CSR74
Series 76 Tuberculosis Testing, Control, Treatment and Commitment
W. Va. Code R. § 64-76-1 General
1.1. Scope. -- This legislative rule establishes specific standards and procedures concerning selective testing for tuberculosis of school children and school personnel; tuberculosis (TB) control in state institutions including reporting of admissions, forms for committing patients, maintenance of patients; standards concerning registration of cases by the Department of Health and Human Resources;
Bureau for Public Health procedures when a patient is a health menace to others; and procedures for immediate involuntary commitment. This rule should be read in conjunction with W.Va. Code §16-3D-1, et seq.
1.2. Authority. -- W.Va. Code §16-3D-9.
1.3. Filing Date. -- April 28, 2016
1.4. Effective Date. -- July 1, 2016
W. Va. Code R. § 64-76-2 Application and Enforcement
2.1. Application -- This rule applies to public health officers, health care providers and facilities, mental health officials and facilities and magistrate and circuit court officials.
2.2. Enforcement -- This rule is enforced by the Commissioner of the Bureau for Public Health or his or her lawful designee and the circuit or magistrate court system.
W. Va. Code R. § 64-76-3 Definitions
3.1. "Bureau" means the Bureau for Public Health.
3.2. "Case" means an occurrence of disease in human or animal which meets a specific case definition listed in the West Virginia Reportable Diseases Protocol Manual or a case definition approved by the Commissioner.
3.3. "Commissioner" means the Commissioner of the Bureau for Public Health.
3.4. "Commit" or "commitment" means to place officially in confinement or custody, as in official confinement in a prison, mental hospital or institution.
3.5. "Confirmed" means a case that meets the clinical case definition or is laboratory confirmed.
3.6. "Contact" means a person who has been exposed to M. tuberculosis infection by sharing air space with a person with infectious tuberculosis.
3.7. "Contact Investigation" means procedures that occur when a case of infectious tuberculosis is identified, including finding contacts exposed to the case, testing and evaluation of contacts to identify Latent Tuberculosis Infection (LTBI) or tuberculosis disease and treatment of these contacts, as indicated.
3.8. "Department" means the Department of Health and Human Resources.
3.9. "Division" means the Division of Tuberculosis Elimination.
3.10. "Diagnosis of tuberculosis" means a determination of tuberculosis based on:
3.10.a. Laboratory criteria for diagnosis:
3.10.a.1. Isolation of M.tuberculosis from a clinical specimen;
3.10.a.2. Demonstration of M.tuberculosis from a clinical specimen by nucleic acid amplification test; or
3.10.a.3. Demonstration of acid-fast bacilli in a clinical specimen when a culture has not been or cannot be obtained.
3.10.b. Clinical case definition:
3.10.b.1. A positive tuberculin skin or another recognized test for tuberculosis infection;
3.10.b.2. Other signs and symptoms compatible with tuberculosis (e.g. an abnormal, unstable [i.e. worsening or improving] chest radiograph, or clinical evidence of current disease);
3.10.b.3. Treatment with two or more anti-tuberculosis drugs; and
3.10.b.4. A completed diagnostic evaluation.
3.11. "Directly Observed Therapy" or "DOT" means an adherence-enhancing strategy in which a health-care worker or other trained person watches a patient swallow each dose of medication and is accountable to the public health system. DOT is the standard method of care for all patients with tuberculosis disease and is an option for patients under treatment for latent infection.
3.12. "Health care provider" means any physician, dentist, nurse, paramedic, psychologist or other person providing medical, dental, nursing, psychological or other health care services of any kind.
3.13. "Health menace" means a patient who has tuberculosis in an infectious state, is at risk of becoming infectious, or is at risk for drug-resistant tuberculosis as determined by the Commissioner or his or her designee, and is unable or unwilling to conduct himself or herself in such a manner as not to expose others to his or her disease or fails to cooperate in his or her standard tuberculosis treatment.
3.14. "Institution" means a hospital, nursing home, clinic or correctional facility responsible for the care and treatment of a patient with tuberculosis.
3.15. "Isolation" means the separation of infected persons or animals from other persons or animals, under the necessary time frame and conditions to prevent the direct or indirect transmission of the infectious agent from the infected persons or animals to other persons or animals who are susceptible or who may spread the disease to others.
3.16. "Laboratory" means any licensed facility or place, however named, for the biologic, microbiologic, serologic, virologic, chemical, hematologic, immuno-hematologic, biophysical, cytologic, pathologic, genetic, molecular or other examination of materials for the purpose of providing medical or epidemiologic assessment of the health of human beings. The term "laboratory" includes both public and private laboratories, free-standing laboratories and hospital laboratories.
3.17. "Medical Evaluation" means an examination to diagnose tuberculosis disease or Latent Tuberculosis Infection (LTBI), to select treatment, and to assess the patient's response to therapy. A medical evaluation may include a medical history and tuberculosis symptom screen, a clinical or physical examination, screening and diagnostic tests (for example: Tuberculin Tests, chest radiographs, bacteriologic examination, and human immunodeficiency virus (HIV) testing), counseling, and treatment referrals.
3.18. "Medical Information" means data or other information regarding the history, examination, radiologic or laboratory findings, diagnosis, treatment, or other clinical care for a person examined or treated for a suspected or actual disease.
3.19. "Non-adherent" means a patient afflicted with tuberculosis who has demonstrated an inability or an unwillingness to adhere to a prescribed treatment regimen, or fails to cooperate in his or her treatment regimen.
3.20. "OLS" means the Office of Laboratory Services in the Bureau.
3.21. "Patient" means any individual confirmed or suspected of having tuberculosis.
3.22. "Physician" means an individual licensed to practice medicine by either the Board of Medicine or the Board of Osteopathy.
3.23. "Reporting source" means an institution or provider which diagnoses or provides treatment for tuberculosis.
3.24. "School children" or "student" means all children under the age of 25 who attend schools in West Virginia including colleges and universities.
3.25. "Tuberculosis" or "TB" means a communicable disease caused by the bacteria, Mycobacterium tuberculosis, which is demonstrated by clinical, bacteriological, radiographic or epidemiological evidence.
3.26. "Tuberculosis test" means a medically valid and recognized procedure for testing an individual for the presence of a tuberculosis infection.
3.27. "WVEDSS" means the West Virginia Electronic Disease Surveillance System, an electronic data system for reporting and tracking cases and outbreaks of infectious diseases with simultaneous reporting of the disease to the Bureau and local health departments.
W. Va. Code R. § 64-76-4 Report of Admissions, Registration by Bureau for Public Health
4.1. Any institution admitting a patient diagnosed with or suspected of having tuberculosis, shall report that admission within ten days to the Division.
4.2. The institution shall make available to the Bureau any patient-related records, reports, and other data pertaining to confirmed and suspected tuberculosis patients, required to: confirm the diagnosis; monitor treatment; follow up on contacts; provide tuberculosis surveillance in the community; or to initiate actions to protect others in the community from risk of disease.
4.3. The institution shall report the death, discharge, and transfer of any patient with tuberculosis to the Division.
4.4. The Division will maintain a current registry of all verified cases of tuberculosis.
4.5. The Bureau or its designee may release tuberculosis related information regarding a patient for the following purposes:
4.5.a. To allow for the diagnosis, treatment and monitoring care by the original reporting source and other health providers in charge of the patient's care or in charge of the patient's contact's care;
4.5.b. To identify a specific patient to the Division of STD, HIV, Hepatitis in the Bureau to compare registries to assist in case finding, and patient care; and
4.5.c. To allow for the diagnosis, treatment and monitoring of care by tuberculosis control programs in other states for the patient who has relocated to another state and for the patient's contacts who live in another state who are under a health care provider's care.
W. Va. Code R. § 64-76-5 Selective Testing of School Children and School Personnel
5.1 Students who are identified with, or are suspected of, active tuberculosis will be temporarily removed from school while their case is reviewed and evaluated by their personal physician and the local health officer. Student may only return to school after their personal physician and the local health officer, in consultation with the Commissioner, make a finding that it is safe and appropriate for the student to do so.
5.2 School personnel who are identified with, or suspected of, active tuberculosis will be placed on temporary suspension from their employment until the local health officer, in consultation with the Commissioner, makes a finding that it is safe and appropriate, for the employee to return to work.
5.3. The Commissioner may require selective testing of students and school personnel for tuberculosis:
5.3.a. When the student or school personnel have traveled to a TB endemic country;
5.3.b. When the student or school personnel have signs and symptoms indicative of TB;
5.3.c. As part of a contact investigation; or
5.3.d. At any time there is reason to suspect an exposure to TB has occurred.
W. Va. Code R. § 64-76-6 Forms for Admitting and Committing Patients; Other Records
6.1. Protocols for appropriate state institution admissions are available from the Division at:
Division of Tuberculosis Elimination WVDHHR/BPH/OEPS 350 Capitol St. Room 125, Charleston, WV 25301 or online at: http://www.dhhr.wv.gov/oeps/tuberculosis/Pages/default.aspx
6.2. Application forms for the voluntary admission of a patient to an institution for the care and treatment of tuberculosis are available from the Bureau and the institution. The patient's attending physician shall submit the forms and any medical reports, such as X-ray and sputum reports to the local health department. The local health department shall then submit forms to the Division for review and approval.
6.3. For involuntary and immediate involuntary commitment of a patient to an institution equipped for the care and treatment of tuberculosis, the Commissioner, or the local health officer as the Commissioner's designee, or another designee of the Commissioner will sign a completed form, and submit the form to the prosecuting attorney for petition to the circuit court, or magistrate court in the circuit judge's absence.
6.4. The institution shall keep a case record for each patient. If the patient is transferred, the institution shall forward a copy of the patient's record to the institution to which the patient is being transferred. If the patient is discharged, the institution shall forward a copy of the patient's record to the local health department.
W. Va. Code R. § 64-76-7 Active Disease and Latent TB Infection Reporting
7.1. Every health care provider, public health officer and every chief medical officer having charge of any hospital, clinic or other similar public or private institution in the State, shall immediately telephone the local health department and report the name, age, sex, race, home address and type of disease of any person with a diagnosis of, or who is suspected of having, tuberculosis. Reporting forms for persons with latent tuberculosis infection and for persons with active tuberculosis disease are available from the Bureau's tuberculosis control program at: Division of Tuberculosis Elimination, WVDHHR/BPH/OEPS, 350 Capitol Street, Room 125, Charleston, WV 25301 or online at: http://www.dhhr.wv.gov/oeps/tuberculosis/Pages/default.aspx
7.2. The health care provider reporting under subsection 7.1. of this section shall also submit a written report on forms made available by the Bureau to the local health department in the patient's county of residence within twenty four (24) hours of a diagnosis of tuberculosis or upon suspicion that a person has tuberculosis.
7.3. The health care provider shall submit updates of patient's progress or lack of progress, including, but not limited to, the latest bacteriology results of cultures, any development of drug resistance, the most recent chest x-ray results, clinical symptoms and treatment to the local health department.
7.4. The health care provider shall report any screening of contacts, with the names and addresses and results of the screening tests of the contacts, to the local health department. Also, the health care provider shall report to the local health department the names of contacts of cases that did not return for follow up for necessary interventions.
7.4.a. The local health officer in the patient's county of residence shall meet with the contact to determine why the contact has not returned for follow up.
7.4.b. The local health officer may request an opportunity to perform a medical evaluation on the contact.
7.5. The local health department shall report all information received under this section to the Bureau.
W. Va. Code R. § 64-76-8 Procedure When Patient Is a Health Menace to Others
8.1. A health care provider shall consider a patient non-adherent if the patient is unable or unwilling to report for medical examinations or is unable or unwilling to adhere to prescribed treatment, such as refusing to take medications or showing other evidence of not taking medications as prescribed, e.g., failure to cooperate with DOT, an incorrect pill count, or a urine test showing no evidence of drug metabolites.
8.2. Any health care provider who is aware of a non-adherent tuberculosis patient shall contact the local health officer for necessary interventions. The local health officer:
8.2.a. Shall meet with the patient to determine why the patient is non-adherent to therapy;
8.2.b. May request an opportunity to examine the non-adherent patient;
8.2.c. May offer the non-adherent patient a course of treatment;
8.2.d. May prescribe DOT for the non-adherent patient; and
8.2.e. May institute proceedings for involuntary commitment or emergency involuntary commitment of the non-adherent patient, if, in the judgment of the health officer, the measures are necessary to protect the public health and safety.
8.3. A patient with tuberculosis will be isolated while he or she is in a communicable stage. The patient will be restricted to his or her isolation room or primary residence until he or she is no longer infectious. The health care provider shall advise immunocompromised individuals and guardians of children of the need for them to be removed from the household, if the patient stays there while infectious.
8.4. Patients unable to adhere to therapy or isolate themselves from others, may voluntarily admit themselves to an institution equipped for the care and treatment of tuberculosis. The local health department shall assist with the admission by following protocols available at Division.
8.5. A patient who has tuberculosis demonstrated by clinical, bacteriological, radiographic or epidemiological evidence will be considered a health menace and considered for commitment to an institution equipped for the care and treatment of tuberculosis if the patient:
8.5.a. Had previous treatment for tuberculosis but failed to complete therapy for reasons unrelated to access to treatment or medication;
8.5.b. Failed to adhere to present prescribed therapy;
8.5.c. Risks infecting others because of inadequate environmental conditions for proper isolation;
8.5.d. Has laboratory tests or a history of nonadherence to anti-tuberculosis medication which indicate possible infection with drug-resistant mycobacterium tuberculosis; or
8.5.e. Has an initial infection with multidrug resistant TB (MDRTB) or extensively drug resistant TB (XDRTB).
8.6. When the local health officer determines that commitment is necessary to protect the health of the public, the local health officer, through the prosecuting attorney, shall petition the circuit court in the county where the patient is a resident for a hearing before the circuit judge to obtain an order to commit the patient to an institution equipped for the care and treatment of persons with tuberculosis. The local health officer shall personally serve notice upon the patient seven days prior to the date of the scheduled hearing.
8.7. The patient has a right to be present at the hearing and has the right to present evidence, confront witnesses and evidence against him or her, and examine testimony offered. The patient should wear a surgical mask or cover their mouth with tissue to contain possible cough secretions and reduce the risk of transmitting the disease.
8.8. The hearing should be conducted in a well-ventilated room.
8.9. If probable cause is found, the patient will be immediately committed to an institution equipped and maintained for the care and treatment of patients afflicted with tuberculosis.
8.10. If the patient being committed has a history of alcohol or other drug abuse, he or she will be committed to an institution equipped for the care and treatment of emotional health for assessment and if needed for complete detoxification, prior to commitment to an institution equipped for the care and treatment of tuberculosis.
8.11. A patient with confirmed or suspected active tuberculosis should be transported with a surgical mask covering his or her nose and mouth. The windows of the vehicle should be kept open and the heating and air-conditioning system should be set on a non-recirculating cycle. Because engineering controls cannot be ensured, personnel transporting the patient should wear respiratory protection meeting current United States Centers for Disease Control and Prevention guidelines.
8.12. Every patient committed to an institution shall observe all the rules of the institution. The patient may be placed apart from others and restrained from leaving the institution as long as he or she continues to be afflicted with tuberculosis and remains a health menace.
8.13. Nothing in this rule may be construed to prohibit any patient committed to any institution from applying to the West Virginia Supreme Court of Appeals for a review of the evidence on which the commitment was made. Nothing in this rule may be construed or operate to empower or authorize the Bureau, the Department or an authorized designee thereof or the chief medical officer of the institution, or their representatives, to restrict in any manner the individual's right to select any method of tuberculosis treatment offered by the institution.
W. Va. Code R. § 64-76-9 Procedures for Immediate Involuntary Commitment
9.1. When a patient has been determined by the Commissioner or by the local health officer as the Commissioner's designee, or by another designee of the Commissioner, to meet the criteria set forth in
section 8 of this rule for commitment to an institution, but also has demonstrated uncooperative and irresponsible behavior with regard to isolation or safety measures and presents a health threat to others, the Commissioner will consider him or her for immediate commitment to an institution equipped for the care and treatment of tuberculosis.
9.2. The Commissioner, or his or her designee, will complete an application for hearing and deliver it to the prosecuting attorney, of the county in which the patient resides, for petitioning the circuit court, or in the judge's absence, for petitioning the magistrate court. The application will contain facts which establish reasons for the commitment.
9.3. If in the absence of the circuit judge, the magistrate finds that immediate detention is necessary, the magistrate may issue an order for the patient to be temporarily detained in isolation for up to twenty-four (24) hours until an application can be presented to the circuit court, or if requested by the patient or his or her counsel, temporary detention may be extended up to an additional forty-eight (48) hours.
9.4. The patient must be detained in a room separate from others with separate ventilation, such as a hospital isolation negative air flow room, a jail where no other inmates are housed at the time or a motel room with separate air conditioning to the outside. The patient must wear a surgical mask or cover his or her mouth with tissues to contain cough secretions to reduce any transmission. The patient should wear a surgical mask or cover their mouth with tissue at all times when out of the isolation room.
Persons in contact with the patient should wear respiratory protection as stated in subsection 8.11. of this
rule.
9.5. Proceedings will be instituted for involuntary commitment as provided in section 8 of this rule.
W. Va. Code R. § 64-76-10 Transportation of Persons
Local Health Departments are responsible for coordinating the transportation of persons with tuberculosis to the appropriate hospital or institution.
W. Va. Code R. § 64-76-11 Administrative Due Process
Any person adversely affected by the enforcement of this rule desiring a contested case hearing to determine any rights, duties, interests or privileges must do so in the manner prescribed in the Bureau procedural rule, Rules for Contested Case Hearings and Declaratory Rulings, 64CSR1.
Series 77 Public Water Systems Design Standards
W. Va. Code R. § 64-77-1 General
1.1. Scope. -- The State of West Virginia provides for the regulation of public water supplies to promote and protect the public health by having the public served safe and potable water. The West Virginia Department of Health and Human Resources, Bureau for Public Health is empowered to adopt rules to implement the intent of the law.
1.1.a. This rule has been prepared to assist professional engineers responsible for the design and construction of public water supply systems. The design of these facilities shall not be limited by minimum requirements, but shall meet the needs of the particular situation. Nothing in this rule shall be construed as preventing the consulting engineer from recommending, or the West Virginia Department of Health and Human Resources (DHHR), Bureau for Public Health, from approving, more effective treatment where local conditions dictate such action.
1.1.b. The West Virginia DHHR, Bureau for Public Health (hereinafter BPH), requires that the applicant or the applicant’s engineer submit reliable engineering data and a report if new or innovative technology is proposed. The BPH may permit an experimental installation. The BPH shall require the experimental installation to be replaced by a conventional installation, if the experimental installation fails to produce satisfactory results, as determined by the BPH.
The Recommended Standards for Water Works, 2007 Edition of the Great Lakes - Upper Mississippi River Boards of State Sanitary Engineers were used as a guide for this rule.
1.2. Authority. -- W. Va. Code §§16-1-4, 16-1-9, and 16-1-9a.
1.3. Filing Date. -- May 2, 2012.
1.4. Effective Date. -- May 2, 2012.
W. Va. Code R. § 64-77-2 Definitions
2.1. AIA. -- American Insurance Association, 1130 Connecticut Ave. N.W., Ste. 1000, Washington, DC 20036, (202) 828-7100.
2.2. ANSI. -- American National Standard Institute, 11 W. 42nd St. 13th Floor, New York, NY 10036, (212) 642-4900.
2.3. API. -- American Petroleum Institute, 1220 L. St. N.W., Washington, D.C. 20005, (202) 682-8000.
2.4. ASTM. -- American Society for Testing and Materials, 1916 Race St., Philadelphia, PA 19103-11878, (215) 299-5400.
2.5. AWWA. -- American Water Works Association, 6666 West Quincy Ave., Denver, CO 80235, (303) 794-7711.
2.6. BPH. -- Bureau for Public Health in the WV Department of Health and Human Resources.
2.7. Chlorine Institute, Inc. -- a trade association of companies that are involved in the safe production, distribution and use of chlorine products. Their address is 2001 L Street, N.W., Suite 506, Washington, D.C. 20036.
2.8. Community Water System. -- A public water system that pipes water for human consumption to at least 15 service connections used by year-round residents, or one that regularly serves at least 25 year-round residents (e.g., municipality, subdivision, manufactured home community).
2.9. CT. -- C, residual disinfectant (mg/l) x T, contact time (min).
2.10. ISO. -- Insurance Service Office, 7 World Trade Center New York, NY 10048, (212) 898-6000.
2.11. MF. -- Membrane filter.
2.12. MPN. -- Most probable number.
2.13. NEC. -- National Electric Code, Quincy, MA 02269.
2.14. NGWA. -- National Ground Water Association, 601 Dempsey Road, Westerville, OH 43081-9895, (800) 551-7379.
2.15. NIOSH. -- National Institute for Occupational Safety and Health, Appalachian Laboratory for Occupational Safety and Health, 944 Chestnut Ridge Road, Morgantown, WV 26505, (304) 291-4126.
2.16. Non-Community Non Transient Water System. -- A public water system that serves at least 25 of the same persons over six months per year (e.g., schools, factories, industrial parks, office buildings).
2.17. NSF. -- National Sanitary Foundation, 3475 Plymouth Rd., P.O. Box 130140, Ann Arbor, MI 48113-0140, (313) 922-6222.
2.18. NTU. -- Nephelometric turbidity units.
2.19. NWSC. -- National Water Systems Council, 600 S. Federal St., Ste. 400. Chicago, IL 60605, (312) 922-6222.
2.20. PVC. -- Polyvinyl chloride.
2.21. Standard Methods for the Examination of Water and Wastewater. -- A joint publication of the American Public Health Association, the AWWA and the Water Pollution Control Association.
2.22. Transient Water System. -- A public water system that serves at least 25 people (not the same people) at least 60 days a year (e.g., highway rest stops, motels, restaurants, parks).
2.23. WSC. -- Water Systems Council, 600 S. Federal St., Ste. 400, Chicago, IL 60605, (312) 922-6222.
2.24. WVDEP. -- West Virginia Department of Environmental Protection, 601 57th Street SE, Charleston, WV 25304, (304) 926-0499.
W. Va. Code R. § 64-77-3 Submission of Plans
3.1. General. -- The applicant or the applicant’s engineer shall submit all reports, final plans and specifications, in the time frame noted in the Bureau for Public Health rule, Public Water System, 64CFR3, prior to the date on which action by the BPH is desired. For public water system wells, if emergency conditions prohibit meeting the permit application requirements, the applicant, the applicant’s engineer, or the West Virginia Certified Water Well Driller that drilled the well shall notify the BPH by facsimile, email or telephone within five (5) calendar days after the emergency well is drilled. Emergency conditions exist when public water systems experience source water outages, low source water quantity due to drought or source water failure to produce enough water for daily demands, or existing source water sudden contamination by a regulated contaminant in which the maximum contaminant level is exceeded. For emergency wells, the applicant or the applicant’s engineer shall submit the permit application within thirty (30) calendar days after the well is drilled. Emergency wells shall meet all of the requirements of this rule and shall be drilled by a West Virginia Certified Water Well Driller. Permits for construction, for waste discharges, for stream crossings, etc., may be required from other federal, state or local agencies. Preliminary plans and the engineer's report shall be submitted for review prior to the preparation of final plans. The BPH shall issue a permit to construct only after review and approval of submitted final, complete detailed applications, plans and specifications.
3.1.a. The applicant shall submit four (4) complete sets of documents for a formal review by the BPH. The documents shall include but not be limited to: application forms; a summary of the basis of design; operation requirements, where applicable; general layout; detailed plans; and specifications.
3.1.b. All installation and operations shall meet or exceed the relevant requirements of the national, state, local or trades’ good practices, regulations and codes, whichever has jurisdiction.
3.2. Engineer's Report. -- The engineer's report for public water systems improvements shall, where pertinent, present the following information:
3.2.a. General information, including a description of the existing public water systems and wastewater facilities; identification of the municipality or area served; and the name and mailing address of the owner or official custodian;
3.2.b. The extent of the public water system, including a description of the nature and extent of the area to be served; provisions for extending the public water system to include additional service areas; and an appraisal of the future requirements for service, including existing and potential industrial, commercial, institutional and other water supply needs;
3.2.c. List the alternate plans where two (2) or more solutions exist for providing public water supply facilities, each of which is feasible and practicable and give reasons for selecting the one (1) recommended, including financial considerations, operational considerations and a comparison of the minimum classifications of the public water system operators required for operation of each alternative facility;
3.2.d. Soil, groundwater conditions, and foundation problems, including a description of: the character of the soil through which water mains are to be laid; foundation conditions prevailing at sites of proposed structures and the approximate elevation of groundwater in relation to subsurface structures;
3.2.e. Water use data, including a description of the customer and population trends as indicated by available records, and the estimated population that will be served by the proposed water supply system or expanded system 20 years in the future in five year intervals or over the useful life of critical structures/equipment. Water use data shall also include present water consumption and the projected average and maximum daily demands, including fire flow demand; present and estimated yields of the sources of supply; unusual occurrences, and unaccounted for water;
3.2.f. Water distribution shall have average, minimum and maximum pressures with and without fire flow at the beginning of the system, at the ends of the system and intermediate points throughout the system. Include supporting data used as basis for design;
3.2.g. Flow requirements, including hydraulic analyses based on flow demands and pressure requirements; and fire flows, when fire protection is provided, which meet the recommendations of the ISO or other similar agency for the service area involved;
3.2.h. Describe the existing wastewater system with special reference to its relationship to existing or proposed public water system structures that may affect the location and operation of the public water system, or that may affect the quality of the supply;
3.2.i. Describe the proposed source or sources of water supply to be developed, the reasons for their selection, and provide the following information:
3.2.i.1. Surface water sources, including hydrological data, stream flow and weather records; safe yield, including all factors that may affect it; and maximum flood flow, together with approval for safety features of the spillway and dam from the appropriate reviewing authority. Include a description of the watershed, noting any existing or potential sources of contamination (such as highways, railroads, chemical facilities, etc.) that may affect water quality, and data on the quality of the raw water with special reference to fluctuations in quality, changing meteorological conditions, regulated contaminant levels, etc.;
3.2.i.2. Groundwater sources, including sites considered; advantages of the site selected; elevations with respect to surroundings; probable character of formations through which the source is to be developed, and geologic conditions affecting the site, such as anticipated interference between proposed and existing wells;
3.2.i.3. A summary of source exploration, test well depth and the method of construction; placement of liners or screen; test pumping rates and their duration; water levels and specific yield; and water quality;
3.2.i.4. Sources of possible contamination such as sewers and sewerage facilities, highways, railroads, landfills, outcroppings of consolidated water-bearing formations, chemical facilities, waste disposal wells, agriculture uses, etc.; and
3.2.i.5. A description and plat of the system's wellhead protection area and plan;
3.2.j. Summarize and establish the adequacy of proposed treatment processes and unit parameters for the treatment of the specific water under consideration. Alternative methods of water treatment and chemical use shall be considered as a means of reducing waste handling and disposal problems. Bench scale test, pilot studies, or demonstrations may be required to establish adequacy for some water quality standards;
3.2.k. Discuss the various aspects of waste disposal from the water treatment plant, including volume, proposed treatment and points of discharge. If discharging to a sanitary sewerage system, verify that the system, including any lift stations, is capable of handling the flow to the sewage treatment works and that the treatment works is capable and will accept the additional loading;
3.2.l. Provide supporting data justifying the use of automatic equipment, including the servicing and operator training to be provided. Manual override shall be provided for any automatic controls.
3.2.m. Give personnel information including the required number of plant operators and relief plant operators, distribution system maintenance personnel, meter readers, and clerical personnel needed to provide adequate coverage;
3.2.n. Project sites, including the discussion of the various sites considered and advantages of the recommended ones; the proximity of residences, industries, and other establishments, and any potential sources of pollution that may influence the quality of the supply or interfere with effective operation of the public water system, such as sewage absorption systems, septic tanks, privies, cesspools, sink holes, sanitary landfills, refuse and garbage dumps, etc.;
3.2.o. Financing, including estimated cost of integral parts of the system; detailed estimated annual cost of operation; and proposed methods to finance both capital charges and operating expenses; and
3.2.p. Summarize planning for future needs and services.
3.3. Plans. -- Plans for public water system improvements shall, where pertinent, provide the following:
3.3.a. A general layout which shall include: a suitable title; the name of the municipality, other entity or person responsible for the water system; the area or institution to be served; the scale; the north point; datums used; boundaries of the municipality or area to be served; date, name and address of the designing engineer; the imprint of the professional engineer's seal or the conformance with engineering registration requirements of West Virginia; 22" X 34" legible prints suitable for reproduction; the location and size of existing and proposed water mains; and the location and nature of existing public water system structures and appurtenances affecting the proposed improvements, noted on one sheet;
3.3.b. Detailed plans which shall include:
3.3.b.1. Stream crossings, providing profiles with elevations of the stream bed and the normal and extreme high and low water levels;
3.3.b.2. Profiles having a horizontal scale of not more than one hundred (100) feet to the inch and a vertical scale of not more than ten (10) feet to the inch, with both scales clearly indicated. Profiles are not required for water main construction; however, critical elevations (high points, low points, water tanks, booster stations, etc.) are required;
3.3.b.3. The location and size of the property to be used for the groundwater development with respect to known references such as roads, streams, section lines, or streets;
3.3.b.4. The topography and arrangement of present or planned wells or structures, with contour intervals not greater than two (2) feet;
3.3.b.5. Elevations of the one hundred (100) year flood level, the floor of the structure, upper terminal of protective casings and outside surrounding grade, using United States Coast and Geodetic Survey, United States Geological Survey or equivalent elevations where applicable as reference;
3.3.b.6. Plat and profile drawings of well construction, showing the estimated diameter and depth of drill holes, casing and liner diameters and depths, grouting depths, elevations and designation of geological formations, water levels and other details to describe the proposed well completely;
3.3.b.7. The location of all existing and potential sources of pollution that may affect the water source or underground treated water storage facilities;
3.3.b.8. The size, length and materials of proposed water mains. The location of existing or proposed streets, water sources, ponds, lakes, storm drains, sanitary sewers, house sewers, septic tanks, disposal fields and cesspools;
3.3.b.9. Schematic flow diagrams and hydraulic profiles showing the flow through various plant units;
3.3.b.10. Piping in sufficient detail to show flow through the plant, including waste lines;
3.3.b.11. The locations of all chemical storage areas, feeding equipment and points of chemical application;
3.3.b.l2. All appurtenances, specific structures, equipment, water treatment plant waste disposal units and points of discharge having any relationship to the plans for water mains and public water system structures;
3.3.b.13. The locations of sanitary or other facilities, such as lavatories, showers, toilets and lockers, when applicable or required by the BPH;
3.3.b.14. The locations, dimensions, and elevations of all proposed plant facilities;
3.3.b.15. The locations of all sampling taps; and
3.3.b.16. An adequate description of any features not otherwise covered by the specifications;
3.3.c. Plan sheet sizes are to be a minimum twenty-two inches by thirty-four inches (22” X 34”). The base mapping for water line construction shall accurately reflect the current surface features along the proposed water line routing; and
3.3.d. Aerial photo-enlargement plans which may be used for water line construction provided the enlargement is done utilizing electronic media (for archival purposes).
3.4. Specifications. -- The applicant or the applicant’s engineer shall supply complete, detailed technical specifications for the proposed project, including: pipe, valves and other building materials; a program for keeping existing public water system facilities in operation during construction of additional facilities so as to minimize interruption of service; laboratory facilities and equipment; the number and design of chemical feeding equipment; and materials or proprietary equipment for sanitary or other facilities including any necessary backflow or backsiphonage protection.
3.5. Design Criteria. -- The applicant or the applicant’s engineer shall submit a summary of the complete design criteria for the proposed project, containing but not limited to the following: the long-term dependable yield of the source of supply; the reservoir surface area, volume and a volume-versus-depth curve, if applicable. The summary shall include the area of watershed, if applicable; the estimated average and maximum day water demands for the design period; number of proposed services; fire-fighting requirements; flash mix, flocculation and settling basin capacities; retention times; unit loadings; the filter area, proposed filtration rate, and filter media; the backwash rate; feeder capacities and ranges, and disinfection facilities and CT calculations, where applicable. The summary shall include special facilities such as aerators, corrosion control, softeners, fluoridation, iron and manganese removal, taste and odor control. Summary shall include design calculations, including head loss, distribution system analysis and pressures at all high and low points under all flow conditions (normal flow, maximum design flow and normal flow with fire flow).
3.6. Revisions to Approved Plans. -- The applicant or the applicant’s engineer shall obtain approval from the BPH before deviating from approved plans or specifications. Revised plans or specifications shall be submitted in time to permit the review and approval of the plans or specifications before any construction work, which will be affected by the changes, is begun.
3.7. Additional Information Required. -- The BPH may require additional information from the applicant that is not part of the construction drawings, such as proprietary technical data, copies of deeds, copies of contracts, etc.
W. Va. Code R. § 64-77-4 General Design Considerations
4.1. General. -- The design of a public water system or treatment process encompasses a broad area and thus, is dependent upon the type of system or process involved.
4.2. Design Basis. -- The system including the water source, treatment facilities, operation and distribution system shall be designed for maximum day demand at the design year.
4.3. Plant Layout. -- The public water systems’ engineer of the plant shall consider: functional aspects of the plant layout, including provisions for future plant expansion; provisions for expansion of the plant waste treatment and disposal facilities, including filter backwash effluent; access roads; site grading; site drainage; walks; driveways; and chemical delivery and storage.
4.4. Building Layout. -- The designer of the building shall provide for: adequate ventilation, lighting, heating and drainage; dehumidification equipment, if necessary; accessibility of equipment for operation, servicing, and removal; flexibility of operation; operator safety; and convenience of operation. The design of the building shall also provide for chemical storage and feed equipment in a separate room to reduce hazards and dust problems.
4.5. Location of Structures. -- The applicant or the applicant’s engineer shall consult the West Virginia Department of Environmental Protection (WVDEP) regarding any structure that is located in such a way that normal or flood stream flows may be impeded. Where practical, all structures shall be located above the one hundred (100) year flood elevation or have adequate protection against one hundred year floods. The U.S. Army Corps of Engineers may require permits.
4.6. Electrical Controls. -- Main switch gear electrical controls shall be located above grade, in areas not subject to flooding.
4.7. Standby Power. -- Standby power may be required by the BPH so that water may be treated or pumped, or both, to the distribution system during power outages to meet the average day demand.
4.8. Shop Space and Storage. -- Adequate facilities shall be included for shop space and storage consistent with the designed facilities.
4.9. Laboratory Facilities. -- Each public water system shall have its own equipment and facilities for routine laboratory testing to ensure proper operation. Laboratory equipment selection shall be based on the characteristics of the raw water source and the complexity of the treatment process involved. Laboratory test kits that simplify procedures for making one or more tests may be acceptable. Necessary laboratory tests shall be performed by an operator or chemist qualified to perform the tests. Analyses conducted to determine compliance with drinking water regulations shall be performed in a laboratory certified by the United States Environmental Protection Agency or the West Virginia Office of Laboratory Services and shall be performed in accordance with Standard Methods for the Examination of Water and Wastewater or alternative methods approved by the BPH. Persons designing and equipping laboratory facilities shall confer with the BPH before beginning the preparation of plans or the purchase of equipment. Methods for verifying adequate quality assurances and for routine calibration of equipment shall be provided.
4.9.a. Laboratory testing equipment. -- At a minimum, the following laboratory equipment shall be provided:
4.9.a.1. Surface water supplies shall have a nephelometric turbidimeter meeting the requirements of “Standard Methods for the Examination of Water and Wastewater”;
4.9.a.2. Each surface water treatment plant utilizing flocculation and sedimentation, including those which lime softens, shall have a pH meter, jar test equipment and titration equipment for both hardness and alkalinity;
4.9.a.3. Each community and non-community, non-transient public water system ion-exchange softening plant, and lime softening plant treating only groundwater shall have a pH meter and titration equipment for both hardness and alkalinity;
4.9.a.4. Each green sand filter using potassium permanganate iron removal plant shall have test equipment capable of accurately measuring iron to a minimum of 0.1 milligrams per liter. Each green sand filter using potassium permanganate manganese removal plant shall have test equipment capable of accurately measuring manganese to a minimum of 0.05 milligrams per liter;
4.9.a.5. Public water systems shall have test equipment for determining both free and total chlorine residual by the Standard Methods for the Examination of Water and Wastewater publication;
4.9.a.6. Public water systems that fluoridate shall have test equipment for determining fluoride by the “Standard Methods for the Examination of Water and Wastewater” publication; and
4.9.a.7. Public water systems that feed poly and/or orthophosphates shall have test equipment capable of accurately measuring phosphates from 0.1 to twenty (20) milligrams per liter.
4.9.b. Physical facilities. -- Sufficient bench space, adequate ventilation, adequate lighting, storage room, laboratory sink, and auxiliary facilities shall be provided. Air conditioning may be necessary.
4.10. Monitoring Equipment. -- Water treatment plants designed to serve three thousand three hundred (3,300) people or more shall be provided with continuous monitoring equipment (including recorders) to monitor water being discharged to the distribution system as follows:
4.10.a. Plants treating surface water and plants using lime for softening shall have the capability to monitor and record free chlorine residual and shall consider having the capacity to monitor and record turbidity; and
4.10.b. Plants treating ground water using iron removal or ion exchange softening shall have the capability to monitor and record free chlorine residual.
4.11. Sample Taps. -- Sample taps shall be provided so that water samples can be obtained from each raw water source and from appropriate locations in each process unit of the treatment system. Taps shall be consistent with sampling needs and shall not be of the petcock type. Taps used for obtaining samples for bacteriological analysis shall be of the smooth-nosed type without an interior or exterior aerator, or other type of appurtenance.
4.12. Facility Water Supply. -- The facility water supply service line and the plant finished water sample tap shall be supplied from a source of finished water at a point where all chemicals have been thoroughly mixed, and the required disinfectant contact time has been achieved. There shall be no cross-connections between the facility water supply service line and any piping, troughs, tanks or other treatment units containing wastewater, treatment chemicals or raw or partially treated water.
4.13. Wall Castings. -- Consideration shall be given to providing extra wall castings built into the structure to facilitate future uses whenever pipes pass through walls of concrete structures.
4.14. Meters. -- All community and non-community, non-transient public water systems water plants shall have a means of metering the raw, finished, washwater, any blended water of different quality and plant use water.
4.15. Piping Color Code. -- To facilitate identification of piping in plants and pumping stations it is recommended that the color scheme in Table 64-77A of this rule be used. In situations where two (2) colors do not have sufficient contrast to easily differentiate between them, a six inch (6”) band of contrasting color shall be on one of the pipes at approximately thirty inch (30”) intervals. The name of the liquid or gas shall also be on the pipe. In some cases it may be advantageous to provide arrows indicating the direction of flow.
4.16. Disinfection. -- All wells, pipes, tanks, and equipment that can convey or store potable water shall be disinfected in accordance with current AWWA procedures. Plans or specifications shall outline the procedure and include the disinfectant dosage, contact time, and method of testing the results of the procedure.
4.17. Operation and Maintenance Manual. -- An operation and maintenance manual including a parts list, parts order form, operator safety procedures and operational trouble-shooting section shall be supplied to the water works as part of any proprietary unit installed in the facility.
4.18. Operator Instruction. -- Provisions shall be made for operator instruction at the start-up of a plant or pumping station following the manufacturers’ representatives trouble-shooting.
4.19. Paints, Coatings, Sealers and Liners. - Paints, coatings, sealers and liners that contact raw, partially treated or potable water and are used in pipes, tanks or equipment that can transport or store water shall have third party certification of compliance with ANSI\NSF Standard 61: Drinking Water System Components - Health Effects.
4.20. Safety. -- Consideration must be given to the safety of water plant personnel and visitors. The design must comply with all applicable safety codes and regulations that may include the Uniform Building Code, Uniform Fire Code, National Fire Protection Association Standards, International Building Code, International Plumbing Code, International Mechanical Code, International Fire Code and state and federal OSHA standards. Examples of some items to be considered include noise arresters, noise protection, confined space entry, protective equipment and clothing, gas masks, safety showers and eye washes, handrails and guards, warning signs, smoke detectors, toxic gas detectors and fire extinguishers.
4.21. Security. -- Appropriate measures to help ensure the security of water system facilities shall be incorporated. Such measures, at a minimum, shall include means to lock all exterior doorways, windows, gates and other entrances to source, treatment, booster stations, valve vaults, meter vaults and water storage facilities. Other measures may include fencing, signage, closed circuit monitoring, real-time water quality monitoring, and intrusion alarms. At a minimum, all finished water storage tanks are to be enclosed by a minimum six feet high chain link fence with a locking gate and the fence is to be located such that maintenance vehicles can maneuver between the tank and fencing.
4.22. Flood Protection. -- Other than surface water intakes, all public water system facilities and water treatment plant access roads shall be protected to at least the one hundred (100) year flood elevation.
4.23. Other Considerations. -- Consideration shall be given to the design requirements of other federal, state and local regulatory agencies for items such as safety requirements, special designs for the disabled, plumbing and electrical codes, construction in the flood plain, etc. Reviews of the design documents (plans and specifications) may be required by local building code officials, prior to construction.
W. Va. Code R. § 64-77-5 Source development
5.1. General. -- In selecting the source of water to be developed, the public water system’s engineer shall prove to the satisfaction of the BPH that an adequate quantity of water will be available, and that the water that is to be delivered to the consumers will meet the current requirements of the rule of the Bureau for Public Health, Public Water Systems, 64CSR3, with respect to microbiological, physical, chemical and radiological qualities. Each water system shall take its raw water from the best available source that is economically reasonable and technically possible.
5.2. Surface Water System. -- A surface water source includes all tributary streams and drainage basins, natural lakes, artificial reservoirs or impoundments above the point of water system intake and ground water under the direct influence of surface water. A source water protection plan shall be adopted by the public water system for the continued protection of the watershed from potential sources of contamination.
5.2.a. Quantity. -- The quantity of water at the source: shall be adequate to meet the maximum projected water demand of the service area as shown by calculations based on a one in fifty year drought or the extreme drought of record; shall provide a reasonable surplus for anticipated growth; shall be adequate to compensate for all losses such as silting, evaporation, seepage, etc.; shall be adequate to provide ample water for other legal users of the source; and shall provide minimum six (6) months storage based on average daily demand for all drainage basins, natural lakes and artificial reservoirs or impoundments.
5.2.b. Quality. -- A sanitary survey and study shall be made of the factors, both natural and man- made, that may affect the quality of the surface water. This survey and study shall include, but not be limited to: determining possible future uses of impoundments or reservoirs; determining the degree of control of watershed by the owner; assessing the degree of hazard to the supply by accidental spillage of materials that may be toxic, harmful or detrimental to treatment processes; obtaining samples over a sufficient period of time to assess the microbiological, physical, chemical and radiological characteristics of the water; assessing the capability of the proposed treatment process to reduce contaminants to applicable standards; and consideration of currents, wind and ice conditions, and the effect of confluent streams.
5.2.c. Minimum Treatment. -- The design of the water treatment plant shall consider the worst conditions that may exist during the life of the facility. The minimum treatment required shall be determined by the BPH. Filtration preceded by pretreatment approved by the BPH shall be provided for all surface waters.
5.2.d. Structures.
5.2.d.1. Design of intake structures shall provide for: withdrawal of water from more than one level if quality varies with depth; separate facilities for release of less desirable water held in storage; where frazil ice may be a problem, holding the velocity of flow into the intake structure to a minimum, generally not to exceed 0.5 feet per second; inspection manholes every one thousand (1000) feet for pipe sizes large enough to permit visual inspection; periodic cleaning of the inlet line; and adequate protection against rupture by dragging anchors, ice, etc. Ports shall be located above the bottom of the stream, lake or impoundment, but at sufficient depth to be kept submerged at low water levels. Where shore wells are not provided, a diversion device shall be capable of keeping large quantities of fish or debris from entering an intake structure and of controlling zebra mussels where applicable.
5.2.d.2. Raw Water pumping wells shall: have electrical controls located above grade and above the one hundred (100) year flood elevation; be accessible; be designed against flotation; be equipped with removable or traveling screens before the pump suction well; provide for introduction of a disinfectant or other chemicals in the raw water transmission main if necessary for quality control; have intake valves and provisions for backflushing or cleaning by a mechanical device and testing for leaks, where practical; have provisions for withstanding surges where necessary and include provisions for adequate ventilation for maintenance personnel.
5.2.d.3. An off-stream reservoir is a facility where water is pumped during periods of good quality and high stream flow for future release to treatment facilities. These off-stream reservoirs shall be constructed to assure that: water quality is protected by controlling runoff into the reservoir; dikes are structurally sound and protected against wave action and erosion; intake structures and devices meet requirements of this section; point of influent flow is separated from the point of withdrawal; and separate pipes are provided for influent to and effluent from the reservoir.
5.2.e. Impoundments and reservoirs.
5.2.e.1. Site preparation shall provide, where applicable: for the removal of brush and trees to high water elevation; for protection from floods during construction; for the abandonment of all water wells that will be inundated, in accordance with requirements of the BPH; and for the abandonment of all oil and gas wells in accordance with WVDEP oil and gas regulations.
5.2.e.2. Construction may require: approval from the WVDEP of the safety features for stability and spillway design; a permit from the WVDEP for controlling stream flow or installing a structure on the bed of a stream or interstate waterway; a withdrawal permit; and a U.S. Army Corps of Engineers permit.
5.3. Groundwater System. -- A groundwater source includes all water obtained from drilled, bored or driven wells, infiltration lines, springs and approved mines.
5.3.a. Quantity.
5.3.a.1. Source Capacity. -- The total developed groundwater source capacity shall equal or exceed the design maximum daily demand. For systems serving five hundred (500) people or more, source capacity shall equal or exceed the design average daily demand with the largest producing well out of service.
5.3.a.2. Number of Sources. -- All community groundwater systems serving five hundred (500) or more people, shall provide a minimum of two (2) good sources of water with sufficient capacity so that with the largest producing source out of service the remaining source or sources can produce sufficient quantity to produce average daily demands.
5.3.a.3. All public water systems shall provide standby power if the system is treating greater than or equal to three (3) million gallons per day.
5.3.a.3.A. To ensure continuous service when the primary power has been interrupted, a power supply shall be provided through connection to at least two (2) independent public power sources, or portable or in-place auxiliary power.
5.3.a.3.B. When automatic pre-lubrication of pump bearings is necessary, and an auxiliary power supply is provided, the pre-lubrication line shall be provided with a valved bypass around the automatic control, or the automatic control shall be wired to the emergency power source.
5.3.b. Quality.
5.3.b.1. Microbiological Quality. -- Public water systems shall provide for disinfection of every new, modified or reconditioned groundwater source prior to use in accordance with AWWA Standard C655. Public water systems shall submit, after disinfection, in accordance with AWWA Standard C654, one (1) or more special purpose water samples to a State certified water quality laboratory for microbiological analysis with results reported to the BPH prior to placing the well into service. The BPH shall require the public water system to take samples to determine if a new groundwater source is under the direct influence of surface water, for all new groundwater sources (wells, springs, mines, etc.). The BPH shall establish the sampling parameters and make the determination. The sampling must be completed within one (1) year after the groundwater sources is in service.
5.3.b.2. Physical and Chemical Quality. -- Public water systems shall have every new groundwater source examined for all regulated primary and secondary contaminants by tests of a representative sample in a State certified water quality laboratory for drinking water, with the results reported to the BPH. Samples shall be collected at or near the conclusion of the test pumping procedure and examined as soon as practical. Field determinations of physical and chemical constituents or special sampling procedures may be required by the BPH.
5.3.c. Location.
5.3.c.1. Public water systems or their engineer shall consult with the BPH prior to design and construction regarding a proposed well location as it relates to required separation between existing and potential sources of contamination and groundwater development. The public water systems or their engineer shall provide a location map, a site map and an inventory of potential contamination activity sources within a two thousand (2000) foot radius of the proposed well location for community and non-community, non-transient public water systems and five hundred (500) foot radius of the proposed well location for transient public water systems. Under no circumstances shall the water well be located closer to sources of microbiological pollution or contamination than as provided in Table 64-77B of this rule.
5.3.c.2. Continued Protection. -- Public water systems shall provide continued protection of the well site from potential sources of contamination through the development of a wellhead protection program as approved by the BPH. Fencing of the site may be required by the BPH.
5.3.d. Testing and Records.
5.3.d.1. The public water system engineer or a West Virginia Certified Water Well Driller shall perform yield and drawdown tests on every production well after construction or subsequent treatment and prior to placement of the permanent pump; have the test methods clearly indicated in the project specifications; have a test pump capacity, at maximum anticipated drawdown, at least 1.5 times the quantity anticipated, and provide for continuous pumping for at least twenty-four (24) hours or until stabilized drawdown has continued for at least six (6) hours when test pumped at 1.5 times the design pumping rate for community and non-transient non-community public water supplies; and provide for continuous pumping for at least eight (8) hours for transient non-community public water supplies.
5.3.d.2. The public water system engineer or a West Virginia Certified Water Well Driller shall provide the following data to the BPH: test pump capacity-head characteristics; static water level; the depth of test pump setting; the time of starting, ending each test cycle and the zone of influence of the well or wells.
5.3.d.3. The public water system engineer or a West Virginia Certified Water Well Driller shall provide recordings and graphic evaluation of the following at one hour intervals or less as may be required by the BPH: pumping rate, pumping water level, drawdown, and water recovery rate and levels. The non-community transient water systems are not required to provide the graphic evaluation of pump test data.
5.3.d.4. The public water system engineer or a West Virginia Certified Water Well Driller shall provide an accurate geographical location such as latitude and longitude or GIS coordinates; determine the geological data from samples collected at five (5) foot intervals and at each pronounced change in formation; record the information and provide a report to the BPH; and be supplemented with information on accurate records of drill hole diameters and depths, assembled order of size and length of casing and liners, grouting depths, formations penetrated, water levels and location of any blast charges.
5.3.e. General Well Construction.
5.3.e.1. Wells shall be covered while unattended during construction. Drilling fluids and additives shall not impart any toxic substances to the water or promote bacterial contamination and shall have third party certification of conformance with ANSI/NSF Standard 60, Drinking Water Treatment Chemicals - Health Effects.
5.3.e.2. Minimum Protected Depths.
5.3.e.2.A. Minimum protected depths of drilled wells shall provide watertight construction to the depth required by the BPH to: exclude contamination; seal off formations that are, or may be, contaminated or yield undesirable water; and provide a minimum casing length as follows:
5.3.e.2.A.1. Ten (10) feet of casing in unconsolidated water bearing formations for wells that are thirty (30) feet deep or less if approved by the BPH;
5.3.e.2.A.2. Twenty (20) feet of casing in unconsolidated water bearing formations for wells that are deeper than thirty (30) feet; or
5.3.e.2.A.3. A minimum of twenty (20) feet of casing in bedrock wells with a minimum of five (5) feet of casing installed into unweathered bedrock. Unweathered bedrock is bedrock that is competent, hard, firmly-consolidated and unaltered by erosion or surficial weathering.
5.3.e.2.B. Other minimum protective depths of casing may be allowed upon the written approval of the BPH in special circumstances (i.e., the well supplies a surface water treatment plant).
5.3.e.3. Temporary Steel Casing. -- Temporary steel casing used for construction shall be capable of withstanding the structural load imposed during its installation and removal.
5.3.e.4. Permanent Steel Casing. -- Permanent steel casing pipe shall: be new steel casing pipe meeting AWWA Standard A-100, ASTM or API specifications for water well construction; have the minimum weights and thickness indicated in Table 64-77D of this rule; have additional thickness and weight if minimum thickness is not considered sufficient to assure the reasonable life expectancy of a well; be capable of withstanding forces to which it is subjected; be equipped with a commercial heat treated tempered drive shoe when driven; have full circumferential welds or threaded coupling joints for twelve (12) inch or less diameter wells. Wells with diameters larger than twelve (12) inch can use non-commercial materials for the drive shoes when driven and shall have full circumferential welds or threaded coupling joints;
5.3.e.5. Nonferrous Casing Materials. -- Nonferrous material proposed as a well casing: shall be resistant to the corrosiveness of the water and to the stresses to which it will be subjected during installation, grouting and operation; and shall comply with ANSI/NSF Standard 61, Water System Components - Health Effects.
5.3.e.6. Plastic Well Casing. -- Plastic well casings, liners, spline-lock mechanical joining systems, couplings and solvents shall be approved by the NSF Standard 14 and 61 and meet ASTM F 480. Temporary casing shall meet NSF Standard 61. Plastic well casing shall not be driven during the installation. Plastic well casing shall be installed in accordance with the manufacturer’s specifications. Evidence of compliance is the display of the NSF seal on each section of casing and liner. All plastic casing and liners shall have a wall thickness that will be of adequate thickness to prevent collapse due to hydrostatic pressure or temperature effects. The minimum wall thickness for plastic well casing shall have a standard dimension ratio (SDR) of 21 or heavier as governed by the ASTM F 480 standards. Plastic well liners shall meet a minimum SDR of 26.
5.3.e.7. Packers. -- Packers shall be of material that will not impart taste, odor, toxic substance or bacterial contamination to the well water. Lead packers are prohibited.
5.3.e.8. Screens. -- Screens shall: be constructed of materials resistant to damage by chemical action of groundwater or cleaning operations and have size of openings based on sieve analysis of formation or gravel pack materials; and have sufficient length and diameter to provide adequate specific capacity and low aperture entrance velocity. Usually the entrance velocity shall not exceed 0.1 feet per second. Screens shall be installed so that the pumping water level remains above the screen under all operating conditions. Where applicable, screens shall be designed and installed to permit removal or replacement without adversely affecting watertight construction of the well and be provided with a bottom plate or washdown bottom fitting of the same material as the screen. Only commercially manufactured screens designed for the intended purpose are permitted. Plastic well screens shall comply with the ANSI/NSF Standard 61 - Water System Components - Health Effects.
5.3.e.9. Grouting requirements.
5.3.e.9.A. The full length of the well casing shall be fully grouted from the lower terminus up to the ground surface, except as noted in parts 5.3.e.9.A.1 through 5.3.e.9.A.3 of this subparagraph.
5.3.e.9.A.1. When drilling through caves, mines or other cavities, the lower portion of the casing shall be grouted in accordance with a method described in this section and a packer or similar bridging device may be used to permit grouting from the top of the cavity.
5.3.e.9.A.2. In unconsolidated aquifers (i.e., sand and gravel) above bedrock, the permanent casing shall be grouted.
5.3.e.9.A.3. In cases where a pitless adaptor is to be installed, upward grouting may terminate at the level of the pitless adapter.
5.3.e.9.B. Grout shall be neat cement, bentonite and cement mixtures, or bentonite. Other materials require the written approval of the BPH. The neat cement, bentonite and cement mixtures, and bentonite shall be mixed according to the manufacturer’s specifications. Drilling muds shall not be used for grouting. Water used shall be fresh (not saline) and uncontaminated. A neat cement grout shall consist of cement and water with not more than six (6) gallons of water per ninety-four (94) pound sack of cement.
5.3.e.9.C. All public water system water wells shall be installed with an annular space seal between the casing and borehole, that hardens or forms a seal to prevent the entrance of water from sources other than the aquifers selected.
5.3.e.9.C.1. When grouting below the water level, grout shall be installed by a positive displacement method, placed from the bottom up. Grout material shall be placed by a positive displacement such as pumping or forced injection by air or hydraulic pressure. Grout shall be injected in the annular space between the inner casing and either the outer casing or the borehole. In wells where the outer casing is left in place, a dry bentonite shall be used while driving the casing.
5.3.e.9.C.2. When grouting above the water level, the annular space shall be a minimum of one and a half (1.5) inches for grout and a positive displacement method, placed from the bottom up, is the preferred method for grouting. The gravity placement method may be used for grouting not to exceed thirty (30) feet. Bentonite chips, pellets or granules with a diameter of three-eighths of an inch (3/8) or less, or neat cement shall either be poured freely down the borehole or added through a tremie pipe to seal the annular space. As the bentonite material is poured into the hole, bridging may occur. A tamper or a weighted line may be necessary to tamp the bentonite material into place.
5.3.e.9.C.3. When underreaming is used to set permanent casing in unconsolidated materials, either a dry or wet bentonite slurry shall be used at the ground surface while the casing is being installed. Upon termination of casing in unweathered bedrock and removal of the underreamer, bentonite or neat cement shall be placed in the bottom of the casing by a positive displacement or gravity placement method before casing is set in bedrock. All other methods require the written approval of the BPH.
5.3.e.9.C.4. If rapid loss of grout material occurs during emplacement, coarse fill material (e.g., sand, gravel, crushed stone or dry cement) may be used in the zones in which the loss is occurring. The remainder of the annular space shall be grouted as provided in this section.
5.3.e.9.C.5. If the annular space cannot be grouted in accordance with this section, alternative methods subject to prior written approval by the BPH may be considered.
5.3.e.10. Upper Terminal Well Construction. -- Permanent casing for all groundwater sources shall project at least twelve (12) inches above the pumphouse floor or at least twelve (12) inches above the final ground surface. Where a well house is constructed, the floor surface shall be at least six (6) inches above the final ground elevation. Sites subject to flooding shall be provided with an earth mound to raise the pumphouse floor to an elevation at least two (2) feet above the highest known flood elevation, or other suitable protection as determined by the BPH. The top of the well casing at sites subject to flooding shall terminate at least three (3) feet above the one hundred (100) year flood level or the highest known flood elevation, whichever is higher, or as the BPH directs. If the three (3) feet above the one hundred (100) year flood elevation or the highest known flood elevation requirement is not practical, the well shall be protected from flood waters entering the well and contaminating the aquifer.
5.3.e.11. Development. -- Every well shall be developed to remove the native silts and clays, drilling mud or finer fraction of the gravel pack. Development shall continue until the maximum specific capacity is obtained from the completed well. Where chemical conditioning is required, the specifications shall include provisions for the method, equipment, chemicals, testing for residual chemicals, and disposal of waste and inhibitors. Where blasting procedures may be used, the specifications shall include the provisions for blasting and cleaning. Special attention shall be given to assure that the grouting and casing are not damaged by the blasting.
5.3.e.12. Capping Requirements. -- All caps shall be Water Systems Council approved. All caps in the 100 year flood plain shall be water tight. All caps above the 100 year flood plain shall, as a minimum, be vector (insects, rodents, snakes, etc.) proof. At all times during the progress of work, the West Virginia Certified Water Well Driller shall provide protection to prevent tampering with the well or entrance of foreign materials.
5.3.e.13. Well Abandonment. -- When a public water system water well is to be abandoned, the work is to be performed by a West Virginia Certified Water Well Driller. The preferred method of abandonment involves casing removal. The borehole shall be completely sealed to reduce concern about channeling in the annular space or inadequate seals between casing and grout. When the casing is removed and the borehole is unstable, grout shall be simultaneously emplaced as the casing is "pulled" to prevent collapse of the borehole and an inadequate seal; however, if the casing is left in place, the casing shall be completely pressure grouted to reduce the possibility of annular channeling. All pumps, wiring, pipes, valves, accessories and hardware shall be removed prior to abandonment. The requirements herein pertain to wells and test holes in consolidated and unconsolidated formations. Each well abandonment shall be considered as an individual problem. Methods and materials are to be selected only after careful consideration of casing material, casing condition, the diameter of the casing, quality and quantity of the original grout seal, the depth of the well, well plumbness, hydrogeologic setting, level of contamination and the zones where contamination occurs. All abandonment procedures shall prohibit groundwater contamination.
5.3.e.13.A. All wells to be abandoned shall be completely filled. The public water system’s engineer or a West Virginia Certified Water Well Driller shall provide procedures and quantities of material used for water well abandonment to the BPH within thirty (30) days after abandonment.
5.3.e.13.B. Wells in Unconsolidated Formations. -- In water-bearing formations consisting of coarse gravel, and when producing wells are located nearby, care shall be taken to select sealing materials that will not affect the producing wells. Concrete may be used if the producing wells can be shut down for a sufficient time to allow the concrete to set. Clean, disinfected sand or gravel may also be used as fill material at the water-bearing formation elevations. The remainder of the well, especially the upper portion, shall be filled with clay, concrete, grout, or neat cement to exclude surface water. The latter method, using clay as the upper sealing material, is especially applicable to abandoned wells with a diameter greater than ten (10) inches. In gravel-packed gravel-envelope, or other wells in which coarse material has been added around the inner casing to within twenty (20) to thirty (30) feet of the surface, sealing outside the casing is very important. Sometimes this sealing may require removal of the gravel or perforation of the casing.
5.3.e.13.C. Wells in Creviced Formations. -- Abandoned wells that penetrate limestone or other creviced or channelized rock formations shall be filled with concrete, grout or neat cement to insure permanence of the seal. The use of clay or sand is not desirable because fine-grained fill material may be displaced by the flow of water through crevices of channels. Alternating layers of coarse stone and concrete may be used for fill material through the water producing horizon if limited vertical movement of water in the formation will not affect the quality or quantity in producing wells. Only concrete, neat cement or grout shall be used in this type of well. The portion of the well between a point ten (10) to twenty (20) feet below and a point ten (10) to twenty (20) feet above the creviced formation shall be sealed and a plug of sealing material formed above the creviced formation.
5.3.f. Source Types and Construction Methods. -- Special Conditions.
5.3.f.1. Radial Water Collector. -- Locations of all caisson construction joints and porthole assemblies shall be indicated. The caisson wall shall be reinforced to withstand the forces to which it will be subjected. Radial collectors shall be in areas and at depths approved by the BPH. Provisions shall be made to assure that radial collectors are horizontal. The top of the caisson shall be covered with a watertight floor or be above the 100 year flood elevation. All openings in the floor shall be curbed and protected from the entrance of foreign material. Commercially available watertight wall sleeves shall be used if the pump discharge piping is placed through the caisson walls.
5.3.f.2. Infiltration Lines. -- Infiltration lines may be considered only where geological conditions preclude the possibility of developing an acceptable drilled well. The area around infiltration lines shall be under the control of the water purveyor for a distance acceptable to or required by the BPH. Flow in the lines shall be by gravity to the collecting well.
5.3.f.3. Naturally Flowing Wells. -- Flow from naturally flowing wells shall be controlled. Permanent casing and grout shall be provided. If erosion of the confining bed appears likely, special protective construction may be required by the BPH.
5.3.f.4. Springs and Mine Openings. -- Springs and mine openings, when used as a source point, shall be protected from the entry of surface water and foreign objects and shall be housed in a permanent structure.
5.3.g. Well Pumps, Discharge Piping and Appurtenances.
5.3.g.1. Line shaft pumps. -- Wells equipped with line shaft pumps shall: have the pump structure firmly connected to the casing or have the casing inserted into a recess extending at least one-half (2) inch into the pump base; have the pump foundation and base designed to prevent water from coming into contact with the joint.
5.3.g.2. Submersible pumps. -- Where a submersible pump is used, the top of the casing shall be effectively sealed against the entrance of water under all conditions of vibration or movement of conductors or cables, and the electrical cable shall be firmly attached to the riser pipe at intervals of twenty (20) feet or less.
5.3.g.3. Discharge piping. -- The discharge piping shall: be designed so that the friction loss will be low; have control valves and appurtenances located above the pumphouse floor when an above-ground discharge is provided; be protected against the entrance of contamination; and be equipped with a check valve, a shutoff valve, a pressure gauge, a means of measuring flow, and a smooth nosed sampling tap located at a point where positive pressure is maintained. Where applicable, discharge piping shall be equipped with an air release-vacuum relief valve located upstream from the check valve, with exhaust/relief piping terminating in a down-turned position at least eighteen (18) inches above the floor and covered with a twenty-four (24) mesh corrosion resistant screen. Discharge piping: shall be valved to permit test pumping and control of each well; shall have all exposed piping, valves and appurtenances protected against physical damage and freezing; shall be properly anchored to prevent movement; and shall be protected against a surge or water hammer. The discharge piping shall be provided with a means of pumping the discharge directly to waste but shall not be directly connected to a sewer.
5.3.g.4. Pitless Well Units. -- The BPH shall be contacted by the public water system or its engineer for approval of specific applications of pitless units. Pitless units shall: be threaded or welded to the well casing; be of watertight construction throughout; be of materials and weight at least equivalent and compatible to the casing; have field connection to the lateral discharge from the pitless unit of threaded, flanged or mechanical joint connection; terminate at least twelve (12) inches above final ground elevation or three (3) feet above the one hundred (100) year flood level or as the BPH directs. If the three (3) feet above the one hundred (100) year flood elevation requirement is not practical, the well shall be protected from flood waters entering the well and contaminating the aquifer. The pitless unit installation shall consist of either a pitless well unit or pitless well adapter and well cap. The pitless unit shall be approved by the NWSC, NGWA or equivalent. If a field weld connection is made, the pitless well unit shall be specifically approved by the manufacturer for such welding. The only field welding permitted is that required to attach the pitless well unit and appurtenances to the casing.
5.3.g.4.A. The design of the pitless unit shall make provisions for: access to disinfect the well; a properly constructed casing vent meeting the requirements specified in this rule; facilities to measure water levels in the well; a cover at the upper terminus of the well that will prevent contamination; a contamination-proof entrance connection for electrical cable; and an inside diameter as great as that of the well casing, up to and including casing diameters of twelve (12) inches, to facilitate work and repair on the well, pump, or well screen. If the three (3) feet above the one hundred (100) year flood elevation requirement is not practical, the well shall be protected from flood waters entering the well and contaminating the aquifer.
5.3.g.5. Casing Vent. -- The public water system or a West Virginia Certified Water Well Driller shall make provisions for venting the well casing to the atmosphere. The pipe connecting the casing to the vent shall be of adequate size to provide rapid venting of the casing. For installations in the 100 year flood plain, refer to paragraph 5.3.e.12 of this rule.
5.3.g.6. Water level measurement. -- The public water system or a West Virginia Certified Water Well Driller shall make provisions for periodic measurement of water levels in the completed well for community and non-community, non-transient public water systems. Where pneumatic water level measuring equipment is used, the measurement shall be made using corrosion resistant materials attached firmly to the drop pipe or pump column and in such a manner as to prevent entrance of foreign materials.
5.3.g.7. Observation wells shall: be constructed in accordance with the requirements for permanent wells if they are to remain in service after completion of a water supply well; and be protected at the upper terminus to preclude entrance of foreign materials.
W. Va. Code R. § 64-77-6 Treatment (General and Clarification)
6.1. General. -- The design of treatment processes and devices shall depend on evaluation of the nature and quality of the particular water to be treated, seasonal variations, the desired quality of the finished water and the mode of operation planned. All treatment processes with only one (1) unit shall be capable of meeting the projected maximum daily demand in eight (8) hours of operation or less to provide "down time" for repairs and maintenance.
6.2. Clarification. -- Clarification is generally considered to consist of any process or combination of processes which reduce the concentration of suspended matter in drinking water prior to filtration. Plants designed for processing surface water shall: provide a minimum of two (2) units each for rapid mix, flocculation and sedimentation; permit operation of the units either in series or parallel where softening is performed and shall permit series or parallel operation where plain clarification is performed; be constructed to permit units to be taken out of service without disrupting operation; be constructed with drains or pumps sized to allow dewatering in a reasonable period of time; provide multiple-stage treatment facilities when required by the BPH; be started manually following a shutdown; and minimize hydraulic head losses between units to allow future changes in processes without the need for repumping. For ground water systems under the direct influence of surface water, the requirements in this subsection may be modified by the BPH, depending on the raw water quality characteristics.
6.2.a. Presedimintation. -- Surface waters containing high turbidity may require pretreatment, usually sedimentation either with or without addition of coagulation chemicals. Presedimentation basins shall have hopper bottoms or be equipped with continuous mechanical sludge removal apparatuses, have provisions for dewatering, provide for incoming water to be dispersed across the full width of the line of travel, prevent short-circuiting, provide for bypassing the presedimentation basins, and have a minimum two (2) hour detention.
6.2.b. Coagulation. -- Is a process using coagulant chemicals and mixing by which colloidal and suspended material are destabilized and agglomerated into settleable or filterable flocs, or both. The engineer shall submit the design basis for the velocity gradient (G value) selected, considering the chemicals to be added, water temperature, color and other related water quality parameters. For surface water plants using direct or conventional filtration, the use of a primary coagulant is required at all times.
6.2.b.1. Equipment. -- Basins shall be equipped with devices capable of providing adequate mixing for all treatment flow rates. Static mixing may be considered where the flow is relatively constant and will be high enough to maintain the necessary turbulence for complete chemical reactions. The coagulation and flocculation basins shall be as close together as possible.
6.2.b.2. Mixing. -- The detention period shall not be more than thirty seconds with mixing equipment capable of imparting a minimum velocity gradient (G) of at least 750 fps/ft. The design engineer shall determine the appropriate G value and detention time through jar testing.
6.2.c. Flocculation. -- Flocculation shall mean a process to enhance agglomeration or collection of smaller floc particles into larger, more easily settleable or filterable particles through gentle stirring by hydraulic or mechanical means.
6.2.c.1. Basin design. -- Inlet and outlet design shall minimize short-circuiting and destruction of floc. Series compartments are recommended to further minimize short-circuiting and to provide decreasing mixing energy with time. Basins shall be designed so that individual basins may be isolated without disrupting plant operation. A drain and/or pumps, or both, shall be provided to handle dewatering and sludge removal.
6.2.c.2. Detention. -- The detention time for floc formation should be at least 30 minutes with consideration to using tapered (i.e., diminishing velocity gradient) flocculation. The flow-though velocity shall be not less than 0.5 or greater than 1.5 feet per minute.
6.2.c.3. Equipment. -- Agitators shall be driven by variable speed drives with the peripheral speed of paddles ranging from 0.5 to three (3.0) feet per second. External, non-submerged motors are recommended.
6.2.c.4. Piping. -- Flocculation and sedimentation basins shall be as close together as possible. The velocity of flocculated water through pipes or conduits to settling basins shall be not less than 0.5 or greater than 1.5 feet per second. Allowances shall be made to minimize turbulence at bends, elevation drops and changes in direction.
6.2.c.5. Other Designs. -- The BPH may allow baffling to be used for flocculation in small plants if the design would permit the velocities and flows noted above to be maintained.
6.2.c.6. Superstructure. -- The BPH may require a superstructure over the flocculation basins.
6.2.d. Sedimentation. -- Sedimentation shall follow flocculation. The detention time for effective clarification is dependent upon a number of factors related to basin design and the nature of the raw water. The following criteria apply to conventional gravity sedimentation units:
6.2.d.1. Detention time. -- A minimum of four (4) hours of settling time shall be provided. This may be reduced to two (2) hours for lime-soda softening facilities treating only groundwater. Reduced sedimentation time may also be approved by the BPH when equivalent effective settling is demonstrated (i.e., tube settlers, lamella plates, etc.) but shall never be less than two (2) hours.
6.2.d.2. Inlet devices. -- Inlets shall be designed to distribute the water equally and at uniform velocities. Open ports, submerged ports, and similar entrance arrangements are required. A baffle shall be constructed across the basin close to the inlet end and shall project several feet below the water surface to dissipate inlet velocities and provide uniform flows across the basin;
6.2.d.3. Outlet devices. -- Outlet weirs or submerged orifices shall be designed to maintain velocities suitable for settling in the basin and to minimize short-circuiting. The use of submerged orifices is recommended in order to provide a volume above the orifices for storage when there are fluctuations in flow;
6.2.d.4. Overflow rate. -- The rate of flow over the outlet weir shall not exceed twenty thousand (20,000) gallons per day per foot of the outlet launder. Where submerged orifices are used as an alternate for overflow weirs, they shall be not lower than three (3) feet below the flow line. The entrance velocity through the submerged orifices shall not exceed 0.5 feet per second;
6.2.d.5. Velocity. -- The velocity through settling basins shall not exceed 0.5 feet per minute. The basins shall be designed to minimize short-circuiting. Fixed or adjustable baffles shall be provided as necessary to achieve the maximum potential for clarification;
6.2.d.6. Overflow. -- An overflow weir or pipe shall be installed that will establish the maximum water level desired on top of the filters. It shall discharge by gravity with a free fall at a location where the discharge will be noted;
6.2.d.7. Superstructure. -- The BPH may require a public water system to build a superstructure over the sedimentation basins. The BPH may allow a cover in lieu of a superstructure, if there is no mechanical equipment in the basins and if provisions are included for adequate monitoring under all expected weather conditions;
6.2.d.8. Sludge collection. -- Shall be designed to ensure the collection of sludge from throughout the basin;
6.2.d.9. Drainage. -- Basins shall be provided with a means for dewatering. Basin bottoms shall slope toward the drain not less than one (1) foot in twelve (12) feet where mechanical sludge collection equipment is not required;
6.2.d.10. Flushing lines. -- Flushing lines or hydrants shall be provided and shall be equipped with backflow prevention devices acceptable to the BPH;
6.2.d.11. Safety. -- Permanent ladders or handholds shall be provided on the inside walls of basins. Guard rails shall be included;
6.2.d.12. Sludge removal. -- Sludge removal design shall provide that sludge pipes shall be not less than three (3) inches in diameter and so arranged as to facilitate cleaning. The entrance to sludge withdrawal piping shall prevent clogging. Valves shall be located outside the tank for accessibility. The operator shall be able to observe and sample sludge being withdrawn from the unit; and
6.2.d.13. Sludge disposal. -- Facilities shall be provided for the proper disposal of sludge.
6.2.e. Solids contact unit. -- Combined softening and clarification units are generally acceptable in situations where water characteristics, especially temperature, do not fluctuate rapidly, flow rates are uniform and operation is continuous. The BPH shall give specific approval to the public water system engineer before these units are considered as clarifiers without softening. The public water system engineer shall design clarifiers for the maximum uniform rate and shall be adjustable to changes in flow that are less than the design rate and for changes in water characteristics. The BPH requires a minimum of two (2) units for surface water treatment.
6.2.e.1. Installation of equipment. -- A representative of the manufacturer shall supervise the installation of mechanical equipment, trouble-shooting, problem solving times and start-up and initial operation.
6.2.e.2. Operating equipment. -- The following shall be provided for plant operation: a complete outfit of tools and accessories; trouble shooting and problem solving manuals; necessary laboratory equipment; and adequate piping with suitable sampling taps located to permit the collection of samples of water from critical portions of the units.
6.2.e.3. Chemical feed. -- Chemicals shall be applied at such points and by such means as to insure satisfactory mixing of the chemicals with the water.
6.2.e.4. Mixing. -- The BPH may require a rapid mix device or chamber ahead of solids contact units to assure proper mixing of the chemicals applied. Mixing devices employed shall be constructed to provide mixing of the raw water with previously formed sludge particles, and prevent deposition of solids in the mixing zone.
6.2.e.5. Flocculation. -- Flocculation equipment shall: be adjustable (speed or pitch, or both); provide for coagulation in a separate chamber or baffled zone within the unit; and provide the flocculation and mixing period to be not less than thirty (30) minutes.
6.2.e.6. Sludge concentrators. -- The equipment shall provide either internal or external concentrators in order to obtain a concentrated sludge with a minimum of waste water. Large basins shall have at least two (2) sumps for collecting sludge with one (1) sump located in the central flocculation zone.
6.2.e.7. Sludge removal. -- Sludge removal design shall provide that sludge pipes shall be not less than three (3) inches in diameter and so arranged as to facilitate cleaning. Entrance to sludge withdrawal piping shall prevent clogging. Valves shall be located outside the tank for accessibility. The design shall permit the operator to observe and sample sludge being withdrawn from the unit.
6.2.e.8. Cross-connections. -- Blow-off outlets and drains shall terminate and discharge at places satisfactory to the BPH. Cross-connection control shall be included for the potable water lines used to backflush sludge lines.
6.2.e.9. Detention period. -- The detention time shall be based on the raw water characteristics and other local conditions that effect the operation of the unit. Based on design flow rates, the detention time shall be two (2) to four (4) hours for suspended solids contact clarifiers and softeners treating surface water and one (1) to two (2) hours for the suspended solids contact softeners treating only groundwater.
6.2.e.10. Suspended slurry concentrate. -- Softening units shall be designed so that continuous slurry concentrates of one per cent (1%) or more, by weight, can be satisfactorily maintained.
6.2.e.11. Water losses. -- Units shall be provided with suitable controls for sludge withdrawal. Total water losses shall not exceed five percent (5%) for clarifiers and three percent (3%) for softening units. The solids concentration of sludge bed to waste shall be three percent (3%) by weight for clarifiers and five percent (5%) by weight for softeners.
6.2.e.12. Weirs or orifices. -- The units shall be equipped with either overflow weirs or orifices constructed so that water at the surface of the unit does not travel more than ten (10) feet horizontally to the collection trough. Weirs shall be adjustable and at least equivalent in length to the perimeter of the tank. Weir loading shall not exceed ten (10) gallons per minute per foot of weir length for units used for clarifiers and twenty (20) gallons per minute per foot of weir length for units used for softeners. Where orifices are used, the loading rates per foot of launder rates shall be equivalent to weir loadings. Either weirs or orifices shall produce uniform rising rates over the entire area of the tank.
6.2.e.13. Upflow rates. -- The BPH shall receive supporting data from the public water system’s engineer to justify rates exceeding the following: one (1) gallon per minute per square foot of area at the sludge separation line for units used for clarifiers; and 1.75 gallons per minute per square foot of area at the slurry separation line; for units used for softeners.
6.2.f. Tube or plate settlers. -- Commercial settler units consisting of variously shaped tubes or plates that are installed in multiple layers and at an angle to the flow may be used for sedimentation following flocculation.
6.2.f.1. General criteria.
6.2.f.1.A. Inlet and outlet considerations. -- The inlets and outlets shall be designed to maintain velocities suitable for settling in the basin and to minimize maldistribution acoss the units.
6.2.f.1.B. Drainage. -- Drain piping from the settler units shall be sized to facilitate a quick flush of the settler units and to prevent flooding other portions of the plant.
6.2.f.1.C. Protection from freezing. -- Although most units are located within a plant, outdoor installations shall provide sufficient freeboard above the top of settlers to prevent freezing in the units. A cover or enclosure is strongly recommended.
6.2.f.1.D. Application rate for tube settlers. -- A maximum rate of two (2) gallons per square foot per minute of cross-sectional area is required, unless higher rates are successfully shown through pilot plant or in-plant demonstration studies.
6.2.f.1.E. Application rate for plates. -- A maximum forward design flow through the inclined plate settler is 0.5 gallons per minute per square foot based on eighty percent (80%) of the projected horizontal plate area.
6.2.f.1.F. Flushing lines. -- Flushing lines shall be provided to facilitate maintenance and shall be properly protected against backflow or back siphonage.
6.2.f.1.G. Placement. -- Modules should be placed in zones of stable hydraulic conditions and in areas nearest effluent launders for basins not completely covered by modules.
6.2.f.1.H. Inlets and Outlets. -- Inlets and outlets shall conform to paragraphs 6.2.d.2 and 6.2.d.3.
6.2.f.1.I. Support. -- The support system must be able to carry the weight of the modules when the basin is drained plus any additional weight to support maintenance.
6.2.f.1.J. Cleaning. -- Provisions shall be made to allow the water level to be dropped, and a water or an air jet system for cleaning the modules.
6.2.g. High Rate Clarification Processes. -- The BPH may approve high rate clarification processes upon demonstration of full scale operation with similar raw water quality conditions. Reductions in detention times and/or increases in weir loading rates shall be justified. Examples of such processes may include dissolved air flotation, ballasted flocculation, contact flocculation/clarification, and helical upflow.
6.3. Filtration. -- Acceptable filters that may be considered are rapid rate gravity filters, rapid rate pressure filters, diatomaceous earth filtration, slow sand filtration, direct filtration, deep bed rapid rate gravity filters, membrane filtration, bag and cartridge filters. The application of any type of filter shall be supported by water quality data representing a reasonable period of time to characterize the variations in water quality. Pilot treatment studies may be required to demonstrate the applicability of the method of filtration proposed.
6.3.a. Rapid rate gravity filters.
6.3.a.1. Pretreatment. -- The use of rapid rate gravity filters shall require pretreatment.
6.3.a.2. Rate of filtration. -- The BPH shall determine the rate of filtration through consideration of such factors as raw water quality, the degree of pretreatment provided, filter media, water quality control parameters, the competency of operation personnel, and other pertinent factors. The maximum rate shall be two (2) gallons per minute per square foot of filter area for sand media, four (4) gallons per minute per square foot of filter area for dual media, and six (6) gallons per minute per square foot of filter for mixed media. In any case, the filter rate shall be proposed and justified by the designing engineer to the satisfaction of the BPH prior to the preparation of final plans and specifications.
6.3.a.3. Number. -- At least two (2) filter units are required. Where only two (2) units are provided, each shall be capable of meeting the plant design capacity (normally the projected maximum daily demand) at the approved filtration rate. Where more than two (2) filter units are provided, the filters shall be capable of meeting the plant design capacity at the approved filtration rate with one (1) filter removed from service. Where declining rate filtration is provided, the variable aspect of filtration rates and the number of filters shall be considered when determining the design capacity for the filters.
6.3.a.4. Structural details and hydraulics. -- The filter structure shall be designed to provide for: vertical walls within the filter; no protrusion of the filter walls into the filter media; covering by superstructure; head room to permit normal inspection and operation; minimum depth of filter box of eight and one half (8½) feet; minimum water depth over the surface of the filter media of three (3) feet; trapped effluent to prevent backflow of air to the bottom of the filters; prevention of floor drainage to the filter with a minimum four (4) inch curb around the filter; prevention of flooding by providing overflow; maximum velocity of treated water in pipe and conduits to filters of two (2) feet per second; cleanouts and straight alignment for influent pipes or conduits where solids loading is heavy, or following lime-soda softening; washwater drain capacity to carry maximum flow; walkways around filters, to be not less than twenty-four (24) inches wide; safety handrails or walls around filter areas adjacent to normal walkways; and construction to prevent cross connections and common walls between potable and non-potable water.
6.3.a.5. Washwater troughs. -- Washwater troughs shall be constructed to have: the bottom elevation above the maximum level of expanded media during washing, a two-inch freeboard at the maximum rate of wash; the top edge level and all at the same elevation; spacing so that each trough serves the same number of square feet of filter area; and maximum horizontal travel of suspended particles to reach the trough not to exceed three (3) feet.
6.3.a.6. Filter. -- The media shall be clean silica sand or other natural or synthetic media free from detrimental chemical or bacterial contaminants. The filter shall be constructed to provide the following characteristics: a total depth of not less than twenty-four (24) inches and generally not more than thirty (30) inches; and a minimum of twelve (12) inches of media with an effective size range no greater than 0.45 mm to 0.55 mm, and uniformity coefficient of the smallest material not greater than 1.65.
6.3.a.7. Types of filter media.
6.3.a.7.A. Anthracite. -- Filter anthracite shall consist of hard, durable anthracite coal particles of various sizes. Blending of non-anthracite material is not acceptable. Anthracite shall have: an effective size of 0.45 mm to 0.55 mm with uniformity coefficient not greater than 1.65 when used alone; an effective size of 0.8 mm to 1.2 mm with a uniformity coefficient not greater than 1.85 when used as a cap; specific gravity of 1.4, acid solubility less than five (5) percent, a Mho’s scale of hardness greater than 2.7 and an effective maximum size of 0.8 mm for anthracite used as a single media on potable groundwater for iron and manganese removal only (effective sizes greater than 0.8 mm may be approved by the BPH based upon on-site pilot plant studies).
6.3.a.7.B. Sand. -- Sand shall be clean silica sand and have an effective size of 0.45 mm to 0.55 mm, a specific gravity greater than 2.5, an acid solubility less than 5 percent and a uniformity coefficient of not greater than 1.65.
6.3.a.7.C. Granular activated carbon (GAC). -- Granular activated carbon media may be considered. The design shall include the following: the media shall meet the basic specifications for filter media as given in this section except that larger size media may be allowed by the BPH where full scale tests have demonstrated that treatment goals can be met under all conditions; there shall be provisions for a free chlorine residual and adequate contact time in the water following the filters and prior to distribution; there shall be means for periodic treatment of filter material for control of bacterial and other growth; and provisions shall be made for frequent replacement or regeneration if GAC is used for filtration.
6.3.a.7.D. High Density Sand. -- High density sand shall consist of hard durable, and dense grain garnet, ilmente, hematite, magnetite, or associated minerals of those ores that resists degradation during handling and use. The high density sand shall contain at least ninety-five (95) percent of the associated material with a specific gravity of 3.8 or higher, have a uniformity coefficient of not greater than 1.65 and have an acid solubility less than five (5) percent.
6.3.a.7.E. Other Media. -- The BPH shall consider other media based on experimental data and operating experience.
6.3.a.7.F. Torpedo sand. -- A three (3) inch layer of torpedo sand shall be used as a supporting media for filter sand, and shall have an effective size of 0.8 mm to 2.0 mm and a uniformity coefficient not greater than 1.7.
6.3.a.7.G. Gravel. -- Gravel, when used as the supporting media, shall consist of a cleaned and washed hard, durable, rounded silica particles and shall not include flat or elongated particles. The coarsest gravel shall be approximately two (2) inches in size when the gravel rests directly on the strainer system and shall extend above the top of the perforated laterals. Not less than four (4) layers of gravel shall be provided in accordance with the size and depth distribution when used with perforated laterals, as illustrated in Table 64-77C of this rule. Reduction of gravel depths or other size gradations may be considered upon justification to the BPH when proprietary filter bottoms are specified or for slow sand filtration.
6.3.a.8. Filter bottoms and strainer systems. -- Departures from the standards under this rule may be acceptable for high rate filters and proprietary bottoms. Porous plate bottoms shall not be used where iron or manganese may clog them or with waters softened by lime. The design of manifold-type collection systems shall minimize loss of head in the manifold and laterals and assure even distribution of washwater and even rate of filtration over the entire area of the filter. The ratio of the area of the final openings of the strainer systems to the area of the filter shall be about 0.003. The total cross-sectional area of the laterals shall be about twice the total area of the final openings. The cross-sectional area of the manifold shall be one and one-half (1½) to two (2) times the total area of the laterals. Lateral perforations without strainers shall be directed downward.
6.3.a.9. Surface wash or subsurface wash. -- Surface or subsurface wash facilities are required except for filters used exclusively for iron, radionuclides, arsenic or manganese removal, and may be accomplished by a system of fixed nozzles or a revolving-type apparatus. All devices shall be designed with the provision for water pressures of at least forty-five (45) pounds per square inch and a properly installed vacuum breaker or other device approved by the BPH to prevent back siphonage if connected to the filtered or finished water system. The rate of flow shall be two (2) gallons per minute per square foot of filter area with fixed nozzles or 0.5 gallons per minute per square foot with revolving arms. Air wash can be considered based on experimental data and operating experiences.
6.3.a.10. Air scouring. -- Air scouring can be considered in place of surface wash. Air flow for air scouring the filter shall be three (3) to five (5) standard cubic feet per minute per square foot of filter area when the air is introduced in the underdrain; a lower air rate shall be used when the air scour distribution system is placed above the underdrains. A method for avoiding excessive loss of the filter media during backwashing shall be provided. Air scouring shall be followed by a fluidization wash sufficient to re-stratify the media. Air shall be free from contamination. Air scour distribution systems shall be placed below the media and supporting bed interface; if placed at the interface the air scour nozzles shall be designed to prevent media from clogging the nozzles or entering the air distribution system. Piping for the air distribution system shall not be flexible hose that will collapse when not under air pressure and shall not be a relatively soft material that may erode at the orifice opening with the passage of air at high velocity. Air delivery piping shall not pass down through the filter media nor shall there be any arrangement in the filter design that would allow short circuiting between the applied unfiltered water and the filtered water. Consideration shall be given to maintenance and replacement of air delivery piping. The backwash delivery system shall be capable of fifteen (15) gallons per minute per square foot of filter surface area; however, when air scouring is provided the backwash rate shall be variable and shall not exceed eight (8) gallons per minute per square foot unless operating experience shows that a higher rate is necessary to remove scoured particles from filter surfaces, and the filter underdrains shall be designed to accommodate air scour piping when the piping is installed in the underdrain.
6.3.a.11. Appurtenances. -- The following shall be provided for every filter: influent and effluent sampling taps; loss of head gauge; rate of flow controls; and an indicating rate-of-flow meter. A modified rate controller that limits the rate of filtration to a maximum rate may be used; Provided, that, equipment that simply maintains a constant water level on the filters is not acceptable unless the rate of flow onto the filter is properly controlled. A pump or a flow meter in each filter effluent line may be used as the limiting device for the rate of filtration only after consultation with the BPH. Provisions shall be made for filtering to waste (rewash) with appropriate measures for cross connection prevention. For surface water systems or groundwater under the direct influence of surface water systems with three (3) or more filters, on-line turbidimeters shall be installed on the effluent line from each filter. All turbidimeters shall report to a recorder that is designed and operated to allow the operator to accurately determine the turbidity at least once every 15 minutes. Turbidimeters on individual filters shall be designed to accurately measure low-range turbidities and have an alarm that sounds when the effluent level exceeds 0.3 NTU. It is recommended the following be provided for every filter: wall sleeves providing access to the filter interior at several locations for sampling or pressure sensing; a flow rate controller capable of providing gradual rate increases when placing the filters back into operation and a pressure hose and storage rack at the operating floor for washing filter walls.
6.3.a.12. Backwash. -- Provisions shall be made for washing filters with a minimum rate of fifteen (15) gallons per minute per square foot, consistent with water temperatures and specific gravity of the filter media. A rate of twenty (20) gallons per minute per square foot or a rate necessary to provide for a fifty percent (50%) expansion of the filter bed is recommended. A reduced rate of ten (10) gallons per minute per square foot may be acceptable for full depth anthracite or granular activated carbon filters. Filtered water shall be provided at the required rate by washwater tanks, a washwater pump, or from the high service main. Washwater pumps shall be in duplicate unless an alternate means of obtaining washwater is available. Washwater pumps shall run a minimum fifteen (15) minutes for the wash of one (1) filter at the design rate of wash. A washwater regulator or valve on the main washwater line shall be provided to obtain the desired rate of filter wash with the washwater valves on the individual filters open wide. A rate-of-flow indicator, preferably with a totalizer, on the main washwater line, shall be located so that it can be easily read by the operator during the washwater process. The design shall prevent rapid changes in backwash water flow. Backwash shall be operator initiated. Automated systems shall be operator adjustable.
6.3.a.13. Miscellaneous. -- Roof drains shall not discharge into the filters or basins and conduits preceding the filters.
6.3.b. Rapid rate pressure filters. -- The normal use of rapid rate pressure filters is for iron and manganese removal and may be used for surface supplies classified as groundwater under direct influence where turbidity is less than or equal to ten (10) NTU. Pressure filters shall not be used in the filtration of other surface supplies or following lime-soda softening.
6.3.b.1. General. -- Minimum criteria relative to rate of filtration, structural details, hydraulics, filter media, etc., provided for rapid rate gravity filters also apply to pressure filters where appropriate.
6.3.b.2. Rate of filtration. -- The rate shall not exceed three gallons per minute per square foot of filter area except where in-plant testing, as approved by the BPH, has demonstrated satisfactory results at higher rates.
6.3.b.3. Details of design. -- The filters shall be designed to provide for: loss of head gauges on the inlet and outlet pipes of each filter; an easily readable meter or flow indicator on each battery of filters (a flow indicator is recommended for each filtering unit); filtration and backwashing of each filter individually with an arrangement of piping as simple as possible to accomplish these purposes; minimum side wall shell height of five (5) feet (a corresponding reduction in side wall height is acceptable where proprietary bottoms permit reduction of the gravel depth); the top of the washwater collectors to be at least eighteen (18) inches above the surface of the media; the underdrain system to efficiently collect the filtered water and to uniformly distribute the backwash water at a rate not less than fifteen (15) gallons per minute per square foot of filter area; backwash flow indicators and controls that are easily readable while operating the control valves; an air release valve on the highest point of each filter; an accessible manhole of adequate size to facilitate inspection and repairs for filters thirty-six (36) inches in diameter; there are sufficient handholds for filters less than thirty-six (36) inches in diameter; manholes should be at least twenty-four (24) inches in diameter where feasible; and means to observe the wastewater during backwashing, and construction to prevent cross-connection.
6.3.c. Diatomaceous earth filtration. -- The use of diatomaceous earth filters may be considered for application to surface waters with low turbidity and low bacterial contamination.
6.3.c.1. Conditions of use. -- Diatomaceous earth filters are expressly excluded from considerations for the following conditions: bacteria removal; color removal; turbidity removal where either the quantity of turbidity is high or the turbidity exhibits poor filterability characteristics; and filtration of waters with high algae counts.
6.3.c.2. Pilot plant study. -- Installation of a diatomaceous earth filtration system shall be preceded by a pilot plant study on the water to be treated. Conditions of the study such as duration, filter rates, head loss accumulation, slurry feed rates, turbidity removal, bacteria removal, etc., shall be approved by the BPH prior to the study. Satisfactory pilot plant results shall be obtained prior to preparation of final construction plans and specifications. The pilot plant study shall demonstrate the ability of the system to meet applicable drinking water standards at all times.
6.3.c.3. Types of filters. -- Pressure or vacuum diatomaceous earth filtration units may be considered for approval; however, the BPH prefers the vacuum type for its ability to accommodate a design that permits observation of the filter surfaces to determine proper cleaning, damage to a filter element, and adequate coating over the entire filter area.
6.3.c.4. Treated water storage. -- Treated water storage capacity in excess of normal requirements shall be provided: to allow operation of the filters at a uniform rate during all conditions of system demand at or below the approved filtration rate; and to guarantee continuity of service during adverse raw water conditions without by-passing the system.
6.3.c.5. Number of units. -- See subdivision 6.3.b. "Rapid Rate Gravity Filters."
6.3.c.6. Pre-coat. -- When pre-coating is accomplished with a filter-to-waste system, 0.15 to 0.2 pounds per square foot of filter area is recommended.
6.3.c.6.A. Application. -- A uniform pre-coat shall be applied hydraulically to each septum by introducing a slurry to the tank influent line and employing a filter-to-waste or recirculation system.
6.3.c.6.B. Quantity. -- Diatomaceous earth in the amount of two tenths (0.2) pounds per square foot of filter area or an amount sufficient to apply a one-eighths (1/8) inch coating shall be used with recirculation.
6.3.c.7. Body feed. -- A body feed system to apply additional amounts of diatomaceous earth slurry during the filter run is required to avoid short filter runs or excessive head losses. Rate of body feed is dependent on raw water quality and characteristics and shall be determined in the pilot plant study. Operation and maintenance can be simplified by providing accessibility to the feed system and slurry lines. Continuous mixing of the body feed slurry is required.
6.3.c.8. Filtration.
6.3.c.8.A. Rate of filtration. -- The recommended nominal rate is one (1.0) gallon per minute per square foot of filter area with a recommended maximum of one and a half (1.5) gallons per minute per square foot. The filtration rate shall be controlled by a positive means.
6.3.c.8.B. Head loss. -- The head loss shall not exceed thirty (30) pounds per square inch for pressure diatomaceous earth filters, or a vacuum of fifteen (15) inches of mercury for a vacuum system.
6.3.c.8.C. Recirculation. -- A recirculation or holding pump shall be employed to maintain differential pressure across the filter when the unit is not in operation in order to prevent the filter cake from dropping off the filter elements. A minimum recirculation rate of one tenth (0.1) gallon per minute per square foot of filter area shall be provided.
6.3.c.8.D. Septum or filter element. -- the filter elements shall be structurally capable of withstanding maximum pressure and velocity variations during filtration and backwash cycles, and shall be spaced such that no less than one (1) inch is provided between elements or between any element and a wall.
6.3.c.8.E. Inlet design. -- The filter influent shall be designed to prevent scour of the diatomaceous earth from the filter element.
6.3.c.9. Backwash. -- A satisfactory method to thoroughly remove and dispose of spent filter cake shall be provided.
6.3.c.10. Appurtenances. -- The following shall be provided for every filter: sampling taps for raw and filtered water; a loss of head or differential pressure gauge; a rate-of-flow indicator, preferably with a totalizer; evaluation of the need for body feed, recirculation and any other pumps; provisions for filtering to waste with appropriate measures for backflow prevention; and a throttling valve used to reduce rates below normal during adverse raw water conditions. Recommend a pressure hose and storage rack at the operating floor for washing the filter; a throttling valve used to reduce rates below normal during adverse raw water conditions; a flow rate controller capable of providing gradual rate increases when placing the filters back into operation; and a continuous monitoring turbidimeter with recorder on each filter effluent for plants treating surface water.
6.3.d. Slow rate gravity filters. -- The use of slow rate gravity filters shall require prior engineering studies to demonstrate the adequacy and suitability of this method of filtration for the specific raw water supply.
6.3.d.1. Quality of raw water. -- Slow rate gravity filtration shall be limited to waters having maximum turbidities of ten (10) NTU and maximum color of fifteen (15) units; this turbidity shall not be attributable to colloidal clay. Raw water quality data shall include examinations for algae to determine the nature and extent of algae growths and their potential adverse affect on filter operation.
6.3.d.2. Number. -- At least two (2) units shall be provided. Where only two (2) units are provided, each shall be capable of meeting the plant design capacity (normally the projected maximum daily demand) at the approved filtration rate. Where more than two (2) filter units are provided, the filters shall be capable of meeting the plant design capacity at the approved filtration rate with one (1) filter removed from service.
6.3.d.3. Structural details and hydraulics. -- Slow rate gravity filters shall be designed to provide: a cover; headroom to permit normal movement by operation personnel for scraping and sand removal operations; adequate hatches and access ports for handling of sand and for ventilation; protection from freezing and an overflow at the maximum filter water level.
6.3.d.4. Rates of filtration. -- The permissible rates of filtration shall be determined by the quality of the raw water and shall be on the basis of experimental data derived from the water to be treated. The nominal rate may be forty-five (45) to one hundred fifty (150) gallons per day per square foot of sand area; higher rates are acceptable when demonstrated to the satisfaction of the BPH.
6.3.d.5. Underdrains. -- Each filter unit shall be equipped with a main drain and an adequate number of lateral underdrains to collect the filtered water. The underdrains shall be spaced so that the maximum velocity of the water flow in the underdrain does not exceed 0.75 feet per second. The maximum spacing of laterals shall not exceed three (3) feet if pipe laterals are used.
6.3.d.6. Filtering material. -- Filter sand shall be placed on graded gravel layers for a minimum depth of thirty (30) inches. The effective size shall be between 0.15 mm and 0.30 mm. The BPH may require a pilot study if larger sand is proposed. The uniformity coefficient shall not exceed 2.5. The sand shall be clean and free from foreign matter. The sand shall be rebedded when scraping has reduced the bed depth to no less than nineteen (19) inches. Where sand is to be reused in order to provide biological seeding and shortening of the ripening process, rebedding shall utilize a “throw over” technique whereby new sand is placed on the support gravel and existing sand is replaced on top of the new sand.
6.3.d.7. Filter gravel. -- The supporting gravel shall conform to the size and depth distribution provided for rapid rate gravity filters.
6.3.d.8. Depth of water on filter beds. -- The design shall provide a depth of at least three (3) to six (6) feet of water over the sand. Influent water shall not scour the sand surface.
6.3.d.9. Control appurtenances. -- Each filter shall be equipped with: influent and effluent sampling taps; an indicating rate-of-flow meter (A modified rate controller that limits the rate of filtration to a maximum rate may be used, but equipment that simply maintains a constant water level on the filters is not acceptable unless the rate of flow onto the filter is properly controlled); a loss of head gauge or other means to measure head loss; an orifice, Venturi meter, or other suitable means of discharge measurement installed on each filter to control the rate of filtration; and an effluent pipe designed to maintain the water level above the top of the filter sand.
6.3.d.10. Ripening. -- Slow sand filters shall be operated to waste after scraping or rebedding during ripening period until the filter effluent turbidity falls to consistently below the regulated drinking water standard established for the system.
6.3.e. Direct filtration. -- Direct filtration, as used herein, refers to the filtration of a surface water or groundwater determined to be under the direct influence of surface water following chemical coagulation and possibly flocculation without prior settling. The nature of the treatment process shall depend upon the raw water quality. In-plant demonstration studies may be appropriate where conventional treatment plants are converted to direct filtration. Where direct filtration is proposed, an engineering report shall be submitted prior to conducting the pilot plant or in-plant demonstration studies.
6.3.e.1. Engineering report. -- The engineering report shall include a historical summary of operating conditions and of meteorological conditions and of raw water quality with special reference to fluctuations in quality and possible sources of contamination. The following raw water parameters shall be evaluated in the report: color; turbidity; bacterial concentration; microscopic biological organisms; temperature; total solids; general inorganic chemical characteristics; and additional parameters as required by the BPH. The report shall also include a description of methods and work to be done during a pilot plant study or, where appropriate, an in-plant demonstration study.
6.3.e.2. Pilot plant studies. -- The BPH may, after approval of the engineering report, require a pilot study or in-plant demonstration study by the public water system or their engineer. The study shall be conducted over a sufficient time to treat all expected raw water conditions throughout the year. The study shall emphasize, but not be limited to, the following items: chemical mixing conditions including shear gradients and detention periods; chemical feed rates; use of various coagulants and coagulant aids; flocculation conditions; filtration rates; filter gradation; types of media and depth of media; filter breakthrough conditions; and the adverse impact of recycling backwash water due to microorganisms, solids, algae, trihalomethane formation and other similar problems; length of filter runs; length of backwash cycles; quantities and make-up of the wastewater. The public water system or their engineer, prior to the initiation of design plans and specifications, shall submit a final report including the engineer's design recommendations to the BPH. The pilot plant filter shall be of a similar type and operated in the same manner as proposed for full scale operation. The pilot study shall demonstrate the minimum contact time necessary for optimum filtration for each coagulant proposed.
6.3.e.3. Pretreatment. -- The final coagulation and flocculation basin design should be based upon the pilot plant or in-plant demonstration studies augmented with applicable portions of subdivision 6.2.b. “Coagulation” and subdivision 6.2.c. “Flocculation.”
6.3.e.4. Filtration. -- Filters shall be rapid rate gravity filters with dual or mixed media. The final filter design shall be based on the pilot plant or in-plant demonstration studies and all portions of subdivision 6.3.a. “Rapid Rate Gravity Filters.” Pressure filters or single media sand filters shall not be used.
6.3.e.5. Appurtenances. -- Every filter shall have an influent and effluent sampling taps, an indicating loss of head gauge and an indicating rate-of-flow meter. A modified rate controller which limits the rate of filtration to a maximum rate may be used but the equipment that simply maintains a constant water level on the filters is not acceptable unless the rate of flow onto the filter is properly controlled; and provisions for filtering to waste with appropriate measures for cross connection control. For systems with three or more filters, on-line turbidimeters shall be installed on the effluent line from each filter. All turbidimeters shall consistently determine and indicate turbidity in NTUs. Each turbidimeter shall report to a recorder that is designed and operated to allow the operator to accurately determine the turbidity at least once every fifteen (15) minutes. Turbidimeters on individual filters should be designed to accurately measure low-range turbidities and have an alarm that sounds when the effluent level exceeds 0.3 NTUs. It is recommended that every filter have wall sleeves providing access to the filter interior at several locations for sampling or pressure sensing; a pressure hose and storage rack at the operating floor for washing filter walls; and a flow rate controller capable of providing gradual rate increases when placing the filters back into operation.
6.3.e.6. Site requirements. -- The plant and its design and land ownership surrounding the plant shall allow for modifications of the plant.
6.3.f. Deep bed rapid rate gravity filters. -- Deep bed rapid rate gravity filters, as used herein, generally refers to rapid rate gravity filters with filter material depths equal to or greater than forty-eight (48) inches. Filter media sizes are typically larger than those required in conventional rapid rate gravity sand filters. Deep bed rapid rate filters may be considered based upon pilot studies approved by the BPH and shall comply with all applicable portions of subdivision 6.3.a. of this section.
6.3.g. Biologically active filters. -- Biologically active filtration, as used herein, refers to the filtration of a surface water (or a ground water with iron, manganese or significant natural organic material) which includes the establishment and maintenance of biological activity within the filtration media. Objectives of biologically active filtration may include control of disinfection byproduct precursors, increased disinfection stability, reduction of substrates for microbial regrowth, breakdown of small quantities of synthetic organic chemicals, reduction of ammonia-nitrogen, and oxidation of iron and manganese. Biological activity can have an adverse impact on turbidity, particle and microbial pathogen removal, disinfection practices; head loss development; filter run times and distribution system corrosion. Design and operation should ensure that aerobic conditions are maintained at all times. Biologically active filtration often includes the use of ozone as a pre-oxidant/disinfectant which breaks down natural organic materials into biodegradable organic matter and granular activated carbon filter media which may promote denser biofilms.
6.3.g.1. Pilot study. -- Biologically active filters may be considered based on pilot studies approved by the BPH. The study objectives must be clearly defined and must ensure the microbial quality of the filtered water under all anticipated conditions of operation. The pilot study shall be greater than three (3) months. The pilot study shall establish empty bed contact time, biomass loading, and/or other parameters necessary for successful operation as required by the BPH. The final filter design shall be based on the pilot study studies and shall comply with all applicable portions of subdivision 6.3.a. of this section.
6.3.h. Membrane Filtration Systems. -- Membrane filtration systems, as used herein, generally refer to a complete and fully functional treatment system employing the use of a selective, physical barrier, consisting of thin sheets or hollow fibers of polymeric and/or inorganic materials, for the removal of suspended and/or dissolved solids from the source water. Such systems are often comprised of several sub-systems, or components, including: Membrane modules or cassettes; the membrane filtration skids, basins, or arrays; backwash sub-systems for frequent removal of suspended solids; chemical clean-in-place sub-systems to maintain the membrane performance and treatment capacity; air compressors and air blowers for control, maintenance, and integrity testing of the membrane system components; pumps; valves; piping; and related motor and supervisory controls necessary to operate and monitor membrane filtration performance. Membrane filtration systems require consideration for prescreening, pre-treatment, post-treatment, and residuals handling to properly maintain long-term performance.
6.3.h.1. Applicability. -- Membrane filtration systems can be identified within four (4) categories, including microfiltration (MF), ultrafiltration (UF), nanofiltration (NF), and reverse osmosis (RO). These categories of membranes shall be used in the following three (3) types of membrane filtration systems; Provided, that the membranes may be used in other systems with the approval of BPH.
6.3.h.1.A. Low Pressure Membrane Filtration Systems. -- Microfiltration and ultrafiltration are specifically used for the removal of suspended solids, including pathogens [e.g., protozoa, bacteria, and viruses, particulate matter, and natural organic matter (NOM)] depending on the membrane material’s effective pore size. These types of systems are recognized as a treatment technique for the removal of Giardia, Cryptosporidium, and other pathogens from surface water sources and groundwater sources under the influence of surface water.
6.3.h.1.B. High Pressure Membrane Filtration Systems. -- Reverse osmosis and nanofiltration are specifically used for the removal of dissolved solids, including monovalent (e.g., sodium and chloride) and divalent (e.g., calcium and manganese) ions, depending on the membrane material’s diffusive properties. These types of systems are recognized as a Best Available Technology (BAT) for the removal of inorganic constituents, e.g. radium and nitrates, from groundwater sources.
6.3.h.1.C. Alternative Membrane Filtration Systems. -- Membrane filtration systems can be configured in various ways to target specific treatment objectives. For example, integrated membrane filtration systems can use a combination of both low and high pressure membrane filtration systems. Electrodialysis reversal (EDR) systems employ electrical charges placed on either side of the membrane filter material to promote ion specific removal through high pressure membrane filtration systems.
6.3.h.2. Design Considerations. -- When considering the use of membrane filtration technologies, the BPH shall be contacted prior to the development of an Engineer’s Report (subsection 3.2) to establish additional requirements necessary for approval, as identified in subdivision 3.2.j of this rule. Design criteria for the proposed membrane filtration system should consist, at a minimum, of data related to gross and net flux (gallons per day per square foot of active membrane area), range of backwash frequencies, backwash duration and rates, range of membrane system recovery as a percentage of production vs. feed water, membrane system area, membrane system configuration, clean-in-place frequencies and solutions, transmembrane pressure operating range, number of skids/basins/arrays, residuals quantity and quality, and related design parameters. To demonstrate treatment efficacy, approval of the Engineer’s Report may be based on the following items:
6.3.h.2.A. Effective Removal Credit. -- The BPH shall make a determination based on the effective log removal value (LRV) credit given for pathogens based on treatment objectives and type of membrane system. Data demonstrating membrane system LRV credit shall be provided to the BPH, including, but not limited to, standard calculations, integrity testing procedures, and actual test data demonstrating performance based on applicable ASTM, AWWA, and other standards.
6.3.h.2.B. Water Quality. -- Water quality can have a measureable and potentially deleterious impact on membrane system performance, impacting the membrane system feasibility and life cycle cost. Therefore, a review of source water quality data, including range of turbidity, pH, alkalinity, hardness, total and dissolved inorganics, total and dissolved organic carbon, water temperature, color, seasonal variations, microbial and algal activity, in addition to other physical parameters should be conducted. Anticipated feed water quality goals, based on the amount and type of pretreatment, shall be evaluated to compare the amount of membrane area and transmembrane pressure required to operate at design flows with seasonal fluctuations in water quality. In anticipation of extreme conditions (e.g., failure of pretreatment, high turbidity, cold temperature, high algal counts, and high organic carbon concentrations), data should be evaluated and summarized, demonstrating how water quality and membrane filtration system capacity can be maintained during and after these extreme conditions. If source water quality is unknown or insufficiently demonstrated, the BPH may require additional water quality sampling for specific constituents, specified frequency, and duration of time to understand potential variations in water quality.
6.3.h.2.C. Redundancy. -- The amount of membrane surface area in operation at any given time shall be sufficient to maintain the rated design capacity, with a portion of the total membrane surface out of service, to maintain redundant systems. A redundant membrane filtration system design should be based on a minimum N-1 installation, where N is the total number of membrane system skids, basins or arrays that are supplied for the specific project, and N-1 is the total of membrane system skids, basins or arrays supplied minus one skid, basin or array out-of-service. Under N-1 operation, consideration shall be given to N being sufficient, such that clean-in-place, integrity, and backwash procedures can be performed with a reasonable impact on design capacity and operations. Additional redundancy shall be provided for critical membrane filtration system components including, but not limited to, valves, sensors, computers and related control systems, compressed air systems, certain pumps and other identified system components.
6.3.h.2.D. Long Term Fouling Allowance. -- Membrane materials are susceptible to declining permeability, or decrease in the amount of water produced for the same transmembrane pressure, because of long term fouling. While water conditions vary, the design should consider space within each skid, basin or array to increase the total membrane surface area to at least one hundred ten percent (110%) of the installed design membrane filtration surface area, without the need to construct additional infrastructure. The reserved unused space shall be provided with false modules or cassettes to maintain uniform conditions within membrane skid, basin or array.
6.3.h.3.E. Membrane Integrity. -- Based on the LRV credit established by the BPH, low pressure membrane systems shall be equipped with an automated membrane integrity test procedure that measures and calculates the effective LRV value of the membrane material on a daily basis. Integrity testing shall be based on the pressure decay test procedure established in ASTM D6908 – Integrity Testing of Water Filtration Membrane Systems or other approved method. When theta (θ) is less than 1, as indicated within the ASTM D908 standard, procedures and data shall be provided on how the membrane material surface wetting angle should be verified to calculate the effective LRV. Concentration of suspended solids within each skid, basin, or array during normal operation may also contribute to the LRV calculation. The membrane filtration system shall be provided with a method for detecting broken or comprised membrane modules, cassettes, and related appurtenances, including equipment and materials necessary to restore membrane system integrity.
6.3.h.3.F. Pretreatment. -- Membrane filtration system designs rely on an understanding of acceptable feedwater characteristics. The performance of the pretreatment process must be coordinated with the membrane system design. Without suitable pretreatment or acceptable feed water quality, membrane life is often shortened due to irreversible fouling or by more frequent, oxidant based clean-in-place procedures to maintain system capacity. At a minimum, the following pretreatment considerations shall be included:
6.3.h.3.F.1. Surface water systems. -- The following pretreatment systems shall be provided for low pressure membrane filtration systems including chemical coagulant and related storage and feed systems, disinfection, clarification consisting of: rapid mix; a combination of flocculation and a four (4) hour retention time based sedimentation basins (the BPH may allow a two (2) hour retention time if the raw water source is a reservoir with a minimum of six (6) months storage and a plate/tube settler is used in the sedimentation basins); or a four (4) hour retention time based solid contact units (the BPH may allow a 2 hour retention time if the raw water source is a reservoir with a minimum of six (6) months storage); and prescreening to protect the membrane filtration from exposure to environmental debris, e.g. leaves, dust, and biota. Four (4) hour retention time shall be based on design flows higher than the production capacity of the membrane filtration system to account for total of production water, backwash water, and clean-in-place make up water, sediment or sludge removal, and other water demand requirements of the planned facility.
6.3.h.3.F.2. Groundwater and groundwater under the influence of surface water based systems. -- The following pretreatment systems shall be provided for high pressure membrane filtration systems for the removal of suspended solids, e.g. cartridge filters or low pressure membrane filtration systems, stabilization of the feed water to prevent scale formation, microbial control, and pH adjustment. Additional consideration shall be given for disinfection, aeration, and ion specific pretreatment depending on treatment objectives. For low pressure membrane filtration systems, pretreatment should minimally consist of at least disinfection to prevent microbial growth and oxidation techniques specific for iron and manganese removal. For both types of systems, additional pretreatment or other treatment techniques may be required based on conditions after well development and operation have been verified because of varying well borehole conditions, e.g. sand production and drawdown characteristics, geological strata, and water quality.
6.3.h.3.G. Pilot studies. -- The BPH requires the development of a pilot system test protocol for evaluation of the proposed treatment process using membrane filtration. The pilot system test protocol shall adequately describe the proposed pilot system setup, sampling frequencies and location, system monitoring and controls, integrity testing procedures, treatment goals and objectives, quality control, and operating conditions, consistent with the planned operation of the full scale membrane filtration system and overall treatment process. Following approval of the pilot system test protocol by the BPH, the pilot study or in-plant demonstration shall be conducted by the public water system and/or their engineer. The pilot study should be conducted over a sufficient time (recommended 6 months to 12 months) to treat anticipated water quality conditions throughout the year for surface water systems, but shall not be less than six (6) weeks. Groundwater systems shall provide a pilot study of at least six (6) weeks, based on anticipated use, e.g., if the well is planned to operate eight (8) hours every day with sixteen (16) hours of recovery, the pilot should be run for a similar twenty-four (24) hour operating condition for up to a total of forty five (45) operational days. The pilot system study should target a range of operating and feed water quality and quantity conditions that could be expected during operation of the planned full scale system. For disposal or treatment of the membrane filtration system reject, concentrate, backwash, and/or spent clean-in-place solutions, additional bench or pilot scale studies may be required to demonstrate the quantity and quality of discharge for the assessment of disposal costs, waste treatment controls, and ability to meet permit requirements established by the BPH and other agencies.
6.3.h.3.H. Total Life Cycle Cost. -- Full scale membrane filtration systems are associated with quantifiable costs for purchase, operation, and maintenance. Where possible, the evaluation and comparison of multiple membrane filtration systems shall be based on similar design parameters and treatment objectives. Capital costs should consider the equipment, appurtenances, infrastructure, and special services required for design, installation, startup, training, and post-startup assistance. Operational costs related to power consumption, chemical use, membrane replacement, maintenance replacement, residuals handling and disposal, and facility operations should also be identified and evaluated. The Engineering Report should be used to establish how operational costs are calculated based on planned production, transmembrane pressure, clean-in-place types and frequencies, membrane life, maintenance reserve, and facility operations. Conservative membrane replacement costs require specific attention to useful life and distribution of payments, and may be supported by operational data from other similar facilities. Pilot study data may be used to verify total life cycle costs prior to construction of full scale facilities.
6.3.h.3.I. Cross-connection Control. -- Membrane skids, basins, or arrays shall be equipped with positive controls to prevent cross-connection of chemical clean-in-place and waste solutions with the treated water supplying the public water system. Methods incorporating block-and-bleed systems and air gaps are preferred for chemical clean-in-place solution piping. Following chemical clean-in-place procedures, rinsing procedures should be considered to reduce the impact of residual chemical clean-in-place solutions on finished water quality.
6.3.h.3.J. NSF Applicability. -- Oils, greases, lubricants and in-situ clean-in-place chemicals in contact with the process water should be NSF/ANSI Standard 60 certified or of suitable food grade quality (FDA). Where applicable, membrane system components and materials in contact with the process water shall be NSF/ANSI Standard 61 certified.
6.4. Disinfection. -- Chlorine is the preferred disinfecting agent. Disinfection may be accomplished with gas and liquid chlorine, calcium or sodium hypochlorites, chlorine dioxide, ozone or ultraviolet light. Other disinfecting agents may be considered, providing reliable application equipment is available and testing procedures for a residual are recognized in "Standard Methods for the Examination of Water and Wastewater," latest edition. Continuous disinfection is required for all public water systems. Since disinfection agents other than chlorine usually demonstrate shortcomings when applied to a public water system, proposals for use of disinfecting agents in combination with chlorine or other than chlorine require approval by the BPH prior to preparation of final plans and specifications.
6.4.a. Chlorination equipment.
6.4.a.1. Type. -- Solution-feed, gas chlorinators or hypochlorite feeders of the positive displacement type shall be provided.
6.4.a.2. Capacity. -- The chlorinator capacity shall be such that a free chlorine residual of at least two (2) milligrams per liter can be maintained in the water to meet the CT for surface water and ground water when maximum flow rate coincides with anticipated maximum chlorine demand, maximum pH and minimum temperatures. The equipment shall be of such design that it operates accurately over the desired feeding range.
6.4.a.3. Standby equipment. -- Standby equipment of sufficient capacity shall be available to replace the largest unit. Spare parts shall be made available to replace parts subject to wear and breakage. If there is a large difference in feed rates between routine and emergency dosages, a gas metering tube shall be provided for each dose range to ensure accurate control of the chlorine feed. ` 6.4.a.4. Automatic switchover. -- Automatic switchover of chlorine cylinders shall be provided, where necessary, to assure continuous disinfection.
6.4.a.5. Automatic proportioning. -- Automatic proportioning chlorinators are required where the rate of flow or chlorine demand is not reasonably constant.
6.4.a.6. Eductor. -- Each eductor shall be selected for the point of application with particular attention given to the quantity of chlorine to be added, the maximum injector water flow, the total discharge back pressure, the injector operating pressure, and the size of the chlorine solution line. Gauges for measuring water pressure and vacuum at the inlet and outlet of each eductor shall be provided.
6.4.a.7. Injector/diffuser. -- The chlorine solution injector/diffuser shall be compatible with the point of application to provide a rapid and thorough mix with all the water being treated. The center of a pipeline is the preferred application point.
6.4.b. Contact time and point of application.
6.4.b.1. Due consideration shall be given to the contact time of the chlorine in water with relation to pH, ammonia, taste-producing substances, temperature, bacterial quality, disinfection byproduct formation potential and other pertinent factors. The disinfectant shall be applied at a point that provides adequate contact time. All basins used for disinfection shall be designed to minimize short circuiting. Additional baffling can be added to new or existing basins to minimize short circuiting and increase contact time.
6.4.b.2. At plants treating surface water, provisions shall be made for applying disinfectant to the raw water, settled water, filtered water, and water entering the distribution system. The contact time as required shall be provided after filtration.
6.4.b.3. As a minimum, at plants treating groundwater, provisions shall be made for applying the disinfectant to the detention basin inlet and water entering the distribution system.
6.4.b.4. The minimum contact time for surface water sources and ground water sources shall be determined by "CT Calculations.” Details for calculating "CT" values are contained in the West Virginia Bureau for Public Health’s rule, Public Water Systems, 64CSR3. If primary disinfection is accomplished using ozone or some other chemical that does not provide a residual disinfectant, then chlorine shall be added to provide a residual disinfectant as provided in subdivision 6.4.c.
6.4.c. Residual chlorine. -- Minimum total chlorine residual at all points in a water distribution system shall be two tenths (0.2) milligrams per liter. Higher residuals may be required depending on pH, temperature and other characteristics of the water. Booster chlorination may be required to maintain proper residuals.
6.4.d. Testing equipment. -- Chlorine residual test equipment recognized in the latest edition of the Standard Methods for the Examination of Water and Wastewater publication, shall be provided and shall be capable of measuring residuals as contained in the West Virginia Bureau for Public Health’s legislative rule, Public Water Systems, 64CSR3. Automatic chlorine residual recorders shall be provided where the chlorine demand varies appreciably over a short period of time. All surface water treatment plants designed to serve three thousand three hundred (3,300) people or more shall be equipped with recording chlorine analyzers and continuous recorders monitoring water entering the distribution system.
6.4.e. Chlorinator piping.
6.4.e.1. Cross-connection protection. -- The chlorinator water supply piping shall be designed to prevent contamination of the treated water supply by sources of questionable quality. At all facilities treating surface water, pre- and post-chlorination systems shall be independent to prevent possible siphoning of partially treated water into the clear well. The water supply to each eductor shall have a separate shut-off valve. No master shut-off valve is allowed.
6.4.e.2. Pipe material. -- The pipes carrying elemental liquid or dry gaseous chlorine under pressure shall be Schedule Eighty (80) seamless steel tubing or other materials recommended by the Chlorine Institute, Inc. (never use poly vinyl chloride, PVC). Rubber, PVC, polyethylene, or other materials recommended by the Chlorine Institute, Inc. shall be used for chlorine solution piping and fittings. Nylon products are not acceptable for any part of the chlorine solution piping system.
6.4.f. Housing. -- Adequate housing must be provided for the chlorination equipment and for storing the chlorine.
6.4.g. Ozone.
6.4.g.1. Design considerations. -- Ozone systems are generally used for the purpose of disinfection, oxidation and microflocculation. When applied, all of these reactions may occur but typically only one is the primary purpose for its use. The other reactions would become secondary benefits of the installation. Effective disinfection occurs as demonstrated by the fact that the “CT” values for ozone, for inactivation of viruses and Giardia cysts, are considerably lower than the “CT” values for other disinfectants. In addition, recent research indicates that ozone can be an effective disinfectant for the inactivation of cryptosporidium. Microflocculation and enhanced filterability has been demonstrated for many water supplies but has not occurred in all waters. Oxidation of organic compounds such as color, taste and odor, and detergents and inorganic compounds such as iron, manganese, heavy metals and hydrogen sulfide has been documented. The effectiveness of oxidation has been varied, depending on pH, alkalinity of the water. These parameters affect the formation of highly reactive hydroxyl radicals, or, conversely the scavenging of this oxidant. High levels of hydroxyl radicals cause lower levels of residual ozone. Depending on the desired oxidation reaction, it may be necessary to maximize ozone residuals or maximize hydroxyl radical formation. For disinfection, residual ozone is necessary for development of “CT”. As a minimum, bench scale studies shall be conducted to determine minimum and maximum ozone dosages for disinfection “CT” compliance and oxidation reactions. More involved pilot studies shall be conducted when necessary to document benefits and disinfectant by-product (DBP) precursor removal effectiveness. Consideration shall be given to multiple points of ozone addition. Pilot studies shall be conducted for all surface waters. Extreme care must be taken during bench and pilot scale studies to ensure acute results: particularly sensitive measurements for gas flow rate, water flow rate, and ozone concentration. Following the use of ozone, the application of a disinfectant which maintains a measurable residual is required throughout the distribution system. Because of the sophisticated nature of the ozone process, the public water system managers must make a commitment to obtaining qualified operators that are trained in the ozone process prior to the startup of an ozone process. The production of ozone is an energy intensive process: substantial economics in electrical usage, reduction in equipment size, and waste heat removal requirements can be obtained using oxygen enriched air or 100% oxygen as feed, and by operating at increased electrical frequency. The use of ozone may result in increases in biologically available organics content of the treated water. Consideration of biologically active filtration may be required to stabilize some treated waters. Ozone use may also lead to increased chlorinated byproduct levels if the water is not stabilized and free chlorine is used for distribution protection.
6.4.g.2. Feed gas preparation.
6.4.g.2.A. General. -- Feed gas can be air, oxygen enriched air or high purity oxygen. Sources of high purity oxygen include purchased liquid oxygen; on-site generation using cryogenic air separation; or temperature, pressure or vacuum swing (absorptive separation) technology. For high purity oxygen-fed systems, dryers typically are not required. Air handling equipment on conventional low pressure feed systems shall consist of an air compressor, water/air separator, refrigerant dryer, heat reactivated desiccant dryer, and particulate filters, Provided, that some “package” ozonation systems for small plants may work effectively operating at high pressure without the refriderant dryer and with a “heat-less” desiccant dryer and may not be required to have those elements. In all cases the design engineer shall ensure that the maximum dew point of -76ºF (-60°C) is not exceeded at any time.
6.4.g.2.B. Air compressor. -- Air compressors shall be of the liquid-ring or rotary lobe, oil-less positive displacement type for smaller systems or dry rotary screw compressors for larger systems. The air compressors shall have the capacity to simultaneously provide for maximum ozone demand, provide the air flow required for purging the desiccant dryers (where required) and allow for standby capacity. Air feed for the compressor shall be drawn from a point protected from rain, condensation, mist, fog and contaminated air sources to minimize moisture and hydrocarbon content of the air supply. A compressed air after-cooler and/or entrainment separator with automatic drain shall be provided to the dryers to reduce the water vapor. A back-up air compressor shall be provided so that the ozone generation is not interrupted in the event of a break-down.
6.4.g.2.C. Air drying. -- Dry, dust-free and oil-free feed gas shall be provided to the ozone generator. Dry gas is essential to prevent formation of nitric acid, to increase the efficiency of ozone generation and to prevent damage to the generator dielectrics. Sufficient drying to a maximum dew point of -76ºF (-60ºC) shall be provided at the end of the drying cycle. Drying for high pressure systems may be accomplished using heatless desiccant dryers only. For low pressure systems, a refrigeration air dryer I series with heat-reactivated desiccant dryers shall be used. A refrigeration dryer capable of reducing inlet air temperature to 40ºF (4ºC) shall be provided for low pressure air preparation systems. The dryer may be of the compressed refrigerant type or chiller water type. For heat-reactivated desiccant dryers, the unit shall contain two desiccant filled towers complete with pressure relief valves, two four-way valves and a heater. In addition, external type dryers shall have a cooler unit and blowers. The size of the unit shall be such that the specified dew point is achieved during a minimum absorption cycle time of sixteen (16) hours while operating at the maximum expected moisture loading conditions. Multiple air dryers shall be provided so that the ozone generation is not interrupted in the event of a breakdown. Each dryer shall be capable of venting “dry” gas to the atmosphere, prior to the ozone generator, to allow start-up when other dryers are “on-line”.
6.4.g.2.D. Air filters. -- Air filters shall be provided on the suction side of the air compressors, between the air compressors and the dryers and between the dryers and the ozone generators. The filter before the desiccant dryers shall be of the coalescing type and be capable of removing aerosol and particulates larger than three tenths (0.3) microns in diameter. The filter after the desiccant dryer shall be of the particulate type and be capable of removing all particulates greater than one tenths (0.1) microns in diameter, or smaller if specified by the generator manufacturer.
6.4.g.2.E. Preparation piping. -- Piping in the air preparation system may be common grade steel, seamless copper, stainless steel or galvanized steel. The piping shall be designed to withstand the maximum pressures in the air preparation system.
6.4.g.3. Ozone Generator.
6.4.g.3.A. Capacity. -- The production rating of the ozone generators shall be stated in pounds per day and kilowatt hours per pound at a maximum cooling water temperature and maximum ozone concentration. The design shall ensure that the minimum concentration of ozone in the generator exit gas is not less than one (1%) percent by weight. Generators shall be sized to have sufficient reserve capacity so that the system does not operate at peak capacity for extended periods of time, which can result in premature breakdown of the dielectrics. The production rate of ozone generators may decrease as the temperature of the coolant increases. If there is to be a variation in the supply temperature of the coolant throughout the year, then the pertinent data shall be used to determine production changes due to the temperature change of the supplied coolant. The design shall ensure that the generators can produce the required ozone at maximum coolant temperature. Ozone backup equipment must be provided.
6.4.g.3.B. Cooling. -- Adequate cooling shall be provided. The required water flow to an ozone generator varies with the ozone production. Normally unit design provides a maximum cooling water temperature rise of 5ºF (2.8ºC). The cooling water shall be properly treated to minimize corrosion, scaling and microbiological fouling of the water side of the tubes. A closed loop cooling water system is often used to insure proper water conditions are maintained. Where cooling water is treated cross connection control shall be provided to prevent contamination of the potable water supply.
6.4.g.3.C. Materials. -- To prevent corrosion, the ozone generator shell and tubes shall be constructed of Type 316L stainless steel.
6.4.g.4. Ozone Contactors. -- The selection of design of the contactor and method of ozone application depends on the purpose for which the ozone is being used.
6.4.g.4.A. Bubble diffusers. -- Where disinfection is the primary application a minimum of two contact chambers each equipped with baffles to prevent short circuiting and induce countercurrent flow shall be provided. Ozone shall be applied using porous-tube or dome diffusers. The minimum contact time shall be ten (10) minutes. A shorter contact time may be approved by the BPH if justified by appropriate design and “CT” considerations. For ozone applications in which precipitates are formed, such as with iron and manganese removal, porous diffusers should be used with caution. Where taste and odor control is of concern, multiple application points and contactors shall be considered. Contactors should be separate closed vessels that have no common walls with adjacent rooms. The contactor must be kept under negative pressure and sufficient monitors shall be provided to protect worker safety. The contactor shall be placed where the entire roof is exposed to the open atmosphere. Large contact vessels shall be constructed of reinforced concrete. All reinforcement bars shall be covered with a minimum of one and one half (1.5) inches of concrete. Smaller contact vessels can be made of stainless steel, fiberglass or other material which is stable in the presence of residual ozone and ozone in the gas phase above the water level. When necessary a system shall be provided between the contactor and the off-gas destruct unit to remove froth from the air and return the other tot the contactor or other location acceptable to the BPH. If foaming is expected to be excessive, then a potable water spray system shall be placed in the contactor head space. All openings into the contactor for pipe connections, hatchways, etc. shall be properly sealed using welds or ozone resistant gaskets such as Teflon or Hypalon. Multiple sampling ports shall be provided to enable sampling of each compartment’s effluent water and to confirm “CT” calculations. A pressure/vacuum relief valve shall be provided in the contactor and piped to a location where there will be no damage to the destruction unit. The diffusion system should work on a countercurrent basis such that ozone is fed at the bottom of the vessel and water is fed at the top of the vessel. The depth of water in bubble diffuser contactors should be a minimum of eighteen (18) feet. The contactor should also have a minimum of three (3) feet of freeboard to allow for foaming. All contactors shall have provisions for cleaning, maintenance and drainage of the contactor. Each contactor compartment shall be equipped with an access hatchway. Aeration diffusers shall be fully serviceable by either cleaning or replacement.
6.4.g.4.B. Other contactors. -- Other contactors, such as venture or aspirating turbine mixer contactor, may be approved by the BPH provided adequate ozone transfer is achieved and the required contact times and residuals can be met and verified.
6.4.g.5. Ozone Destruction Unit. -- A system for treating the final off-gas from each contactor shall be provided in order to meet safety and air quality standards. Acceptable systems include thermal destruction and thermal/catalytic destruction units. To reduce the risk of fires, the use of units that operate at lower temperatures is encouraged, especially where high purity oxygen is the feed gas. The maximum allowable ozone concentration in the discharge is 0.1 ppm by volume. At least two (2) units shall be provided that are each capable of handling the entire gas flow. Exhaust blowers shall be provided in order to draw off-gas from the contactor into the destruct unit. Catalysts shall be protected from froth, moisture and other impurities which may harm the catalysts. The catalysts and heating elements shall be located where they can easily be reached for maintenance.
6.4.g.6. Piping Materials. -- Only low carbon 304L or 316L stainless steel shall be used for ozone service with 316L the preferred.
6.4.g.7. Joints and Connections. -- Connections on piping used for ozone service shall be welded where possible. Connections with meters, valves, or other equipment are to be made with flanged joints with ozone resistant gaskets, such as Teflon or Hypalon. Screwed fittings shall not be used because of their tendency to leak. A positive closing plug or butterfly valve plus a leak-proof check valve shall be provided in the piping between the generator and the contactor to prevent moisture reaching the generator.
6.4.g.8. Instrumentation. -- Pressure gauges shall be provided at the discharge from the air compressor, at the inlet to the refrigeration dryers, at the inlet and outlet of the desiccant dryers, at the inlet to the ozone generators and contactors and at the inlet to the ozone destruction unit. Electric power meters shall be provided for measuring the electric power supplied to the ozone generators. Each generator shall have a trip that shuts down the generator when the wattage exceeds a certain preset level. Dew point monitors shall be provided for measuring the moisture of the feed gas from the desiccant dryers. Because it is critical to maintain the specified dew point, it is recommended that continuous recording charts be used for dew point monitoring which allows for proper adjustment of the dryer cycle. Where there is potential for moisture entering the ozone generator during shutdown, post generator dew point monitors shall be used. Air flow meters shall be provided for measuring air flow from the desiccant dryers to each of other ozone generators, air flow to each contactor and purge air flow to the desiccant dryers. Temperature gauges shall be provided for the inlet and outlet of the ozone cooling water and the inlet and outlet of the ozone generator feed gas, and if necessary, for the inlet and outlet of the ozone power supply cooling water. Water flow meters shall be installed to monitor the flow of cooling water to the ozone generators and, if necessary, to the ozone power supply. Ozone monitors shall be installed to measure ozone concentration in both the feed-gas and off gas from the contactor and in the off-gas from the destruct unit. For disinfection systems, monitors shall also be provided for monitoring ozone residuals in the water. The number and location of ozone residual monitors shall be such that the amount of time that the water is in contact with the ozone residual can be determined. A minimum of one (1) ambient ozone monitor shall be installed in the vicinity of the contactor and a minimum of one (1) shall be installed in the vicinity of the generator. Ozone monitors shall also be installed in any areas where ozone may accumulate.
6.4.g.9. Alarms. -- The following alarm/shutdown systems shall be considered at each installation: Dew point shutdown/alarm - this system should shut down the generator in the event the system dew point exceeds -76°F(-60ºC). Ozone generator cooling water flow shutdown/alarm - this system shall shutdown the generator in the event that cooling water flows decrease to the point that generator damage could occur. Ozone power supply cooling water flow shutdown/alarm - this system shall shutdown the power supply in the event that cooling water flow decreases to the point that damage could occur to the power supply. Ozone generator cooling water temperature shutdown/alarm - this system shall shutdown the generator if either the inlet or outlet cooling water exceeds a certain preset temperature. Ozone power supply water temperature shutdown/alarm - this system shall shutdown the power supply if either the inlet or outlet cooling water exceeds a certain preset temperature. Ozone generator inlet feed-gas temperature shutdown/alarm - this system shall shutdown the generator if the feed-gas temperature is above a preset value. Ambient ozone concentration shutdown/alarm - the alarm shall sound when ozone level in the ambient air exceeds 0.1 ppm or a lower value chosen by the water supplier and ozone generator shutdown shall occur when ambient ozone levels exceed 0.3 ppm (or a lower level) in either the vicinity of the ozone generator or the contactor. Ozone destruct temperature alarm - this alarm shall sound when temperature exceeds a preset value.
6.4.g.10. Safety. -- The maximum allowable ozone concentration in the air to which workers may be exposed shall not exceed 0.1 ppm (by volume). Noise levels resulting from the operating equipment of the ozonation system shall be controlled to within acceptable limits by special room construction and equipment isolation. High voltage and high frequency electrical equipment shall meet current electrical and fire codes. Emergency exhaust fans shall be provided in rooms containing the ozone generators to remove ozone gas if leakage occurs. A portable purge air blower shall be provided that removes residual ozone in the contactor prior to entry for repair or maintenance. A sign shall be posted indicating “No smoking, oxygen in use” at all entrances to the treatment plant. In addition, no flammable or combustible materials shall be stored within the oxygen generator areas.
6.4.g.11. Construction considerations. -- Prior to connecting the piping from the desiccant dryers to the ozone generators the air compressors shall be used to blow the dust out of the desiccant. The contactor shall be tested for leakage after sealing the exterior and this can be done by pressurizing the contactor and checking for pressure losses. Connections on the ozone service line shall be tested for leakage using the soap-test method.
6.4.h. Chlorine Dioxide. -- May be considered as a primary and residual disinfectant, a pre-oxidant to control taste and odors, to oxidize iron and manganese, and to control hydrogen sulfide and phenolic compounds. It has been shown to be a strong disinfectant which does not form THMs or HAAs. When choosing chlorine dioxide, consideration must be given to formation of the regulated byproducts, chlorite and chlorate.
6.4.h.1. Chlorine dioxide generators. -- Chlorine dioxide generation equipment shall be factory assembled pre-engineered units with a minimum efficiency of 95 percent (95%). The excess free chlorine shall not exceed three percent (3%) of the theoretical stoichiometric concentration required.
6.4.h.2. Feed and storage facilities. -- Chlorine gas and sodium chlorite feed and storage facilities shall comply with subsection 7.0.
6.4.h.3. Other design requirements. -- The design shall comply with all applicable portions of subdivisions 6.4.a, 6.4.b, 6.4.d and 6.4.e of this section. The minimum residual disinfectant shall be established by the BPH.
6.4.h.4. Public notification. -- Notification of a change in disinfection practices and the schedule for the changes shall be made known to the public; particularly to hospitals, kidney dialysis facilities and fish breeders, as chlorine dioxide and its byproducts may have similar effects as chloramines.
6.4.i. Ultraviolet light. -- The United States Environmental Protection Agency (EPA) has promulgated the Long Term 2 Enhanced Surface Water Treatment Rule (LT2ESWTR) to further reduce microbial contamination of drinking water. The rule requires additional treatment for some public water supplies based on their source water Cryptosporidium concentrations and current treatment practices. Ultraviolet light (UV) disinfection is one option public water supplies have to comply with the additional treatment requirements. The EPA has released a document entitled Ultraviolet Disinfection Guidance Manual for the Final Long Term 2 Enhanced Surface Water Treatment Rule. This guidance manual may be used as the basis for the validation, design and operation of all UV systems used for public water systems and for the development of the recommended standards for those systems. Supplemental disinfection for additional virus inactivation and to provide a residual in the water distribution system is required by the BPH.
6.4.i.1. Criteria for UV Water Treatment Devices. -- UV water treatment devices must be validated by a third-party entity in accordance with the USEPA Ultraviolet Light Disinfection Guidance Manual (USEPA UVDGM), the German Association of Gas and Water (UVGW), the Austrian Standards Institute (ONORM), the National Water Research Institute/American Water Works Association Research Foundation (NWR/AwwaRF), the Class A criteria under ANSI/NSF Standard 55- Ultraviolet Microbiological Water Treatment Systems; or other standards approved by the BPH. The validation must demonstrate that the unit is capable of providing a UV light dose of 40 millijoules per square centimeter (mJ/cm2) throughout the reactor based on water quality, specifically transmittance of the dose through the treated water. Higher dosages may be required depending on application, e.g., type of pathogen inactivation and water quality conditions. In addition to the requirements cited in the USEPA UVDGM each UV water treatment device shall meet the following: 1) The UV assemblies shall be accessible for visual observation, cleaning and replacement of the lamp, lamp jackets and sensor window/lens. A wiper assembly or chemical-in-place system should be installed to allow in-situ cleaning of lamp jackets. Adequate controls shall be in place to prevent contamination of potable water with cleaning chemicals. 2) An automatic shutdown valve shall be installed in the water supply line ahead of the UV treatment system that is activated whenever the water treatment system losses power or is tripped by a monitoring devise when the dosage is below the validated operating design dose. When power is not being supplied to the UV unit the valve shall be in a closed (fail-safe) position. 3) The UV housing shall be stainless steel 304 or 316L. 4) A flow or time delay mechanism shall be provided to permit sufficient time for UV lamp warm-up before water flows from the unit upon startup. 5) A sufficient number (required number plus one) of parallel UV treatment systems shall be provided to assure a continuous water supply when one unit is out of service unless other disinfection can be provided when the unit is out of service.
6.4.i.2. Record keeping and access. -- A record shall be kept of the dates of lamp replacement and cleaning, a record of when the device was shut down and the reason for the shutdown. The BPH shall have access to the UV water treatment system and records.
6.4.j. Other disinfecting agents. -- Proposals for use of disinfecting agents other than those listed must be pre-approved by the BPH, prior to preparation of the final plans and specifications.
6.5. Softening. -- The softening process selected shall be based upon the mineral qualities of the raw water and the desired finished water quality in conjunction with requirements for disposal of sludge or brine waste, cost of plant, cost of chemicals and plant location. Applicability of the process chosen shall be demonstrated.
6.5.a. Lime or lime-soda process. -- Design standards for rapid mix, flocculation and sedimentation are in "Clarification," subsection 6.2. of this rule. Additional consideration shall be given to the following process elements.
6.5.a.1. Hydraulics. -- When split treatment is used, the bypass line shall be sized to carry total plant flow, and an accurate means of measuring and splitting the flow shall be provided.
6.5.a.2. Aeration. -- Determinations shall be made for the carbon dioxide content of the raw water. When concentrations exceed ten (10) milligrams per liter, the economics of removal by aeration as opposed to removal with lime shall be considered if it has been determined that dissolved oxygen in the finished water will not cause corrosion problems in the distribution system.
6.5.a.3. Chemical feed point. -- Lime shall be fed directly into the rapid mix basin.
6.5.a.4. Rapid mix. -- Rapid mix basins shall provide not more than thirty (30) seconds detention time with adequate velocity gradients to keep the lime particles dispersed.
6.5.a.5. Stabilization. -- Equipment for stabilization of water softened by the lime or lime-soda process is required.
6.5.a.6. Sludge collection. -- Mechanical sludge removal equipment shall be provided in the sedimentation basin. Sludge recycling to the rapid mix shall be provided not to exceed a rate of ten percent (10%) of the incoming flow.
6.5.a.7. Sludge disposal. - Provisions shall be included in the water treatment plant design for proper disposal of softening sludge.
6.5.a.8. Disinfection. -- The use of excess lime is not an acceptable substitute for disinfection.
6.5.a.9. Plant start-up. -- The plant processes shall be manually started following shut-down.
6.5.b. Cation exchange process. -- Alternative methods of hardness reduction shall be investigated when the sodium content and dissolved solids concentration is of concern.
6.5.b.1. Pre-treatment requirements. -- Iron, manganese, or a combination of the two, shall not exceed 0.3 milligrams per liter in the water as applied to the ion exchange resin. Pre-treatment is required when the content of iron, manganese, or a combination of the two (2), is one (1) milligram per liter or more. Waters having five (5) units or more turbidity shall not be applied directly to the cation exchange softener.
6.5.b.2. Design. -- The units may be of pressure or gravity type, of either an upflow or downflow design. Automatic regeneration based on volume of water softened shall be used unless manual regeneration is justified and is approved by the BPH. A manual override shall be provided on all automatic controls.
6.5.b.3. Exchange capacity. -- The design capacity for hardness removal shall not exceed twenty thousand (20,000) grains per cubic foot when resin is regenerated with 0.3 pounds of salt per kilogram of hardness removed.
6.5.b.4. Depth of resin. -- The depth of the exchange resin shall not be less than three (3) feet.
6.5.b.5. Flow rates. -- The rate of softening shall not exceed seven (7) gallons per minute per square foot of bed area, and the backwash rate shall be six (6) to eight (8) gallons per minute per square foot of bed area. Rate-of-flow controllers or the equivalent shall be installed for the rate of softening.
6.5.b.6. Freeboard. -- The freeboard will depend upon the specific gravity of the resin and the direction of water flow. Generally, the washwater collector shall be twenty-four (24) inches above the top of the resin on downflow units.
6.5.b.7. Underdrains and supporting gravel. -- The bottoms, strainer systems and support for the exchange resin shall conform to criteria provided for rapid rate gravity filters.
6.5.b.8. Brine distribution. -- Facilities shall be included for even distribution of the brine over the entire surface of both upflow and downflow units.
6.5.b.9. Cross-connection control. -- Backwash, rinse and air relief discharge pipes shall be installed in such a manner as to prevent any possibility of back-siphonage.
6.5.b.10. Bypass piping and equipment. -- A bypass shall be provided around softening units to produce a blended water of desirable hardness. Totalizing meters shall be installed on the bypass line and on each softener unit. The bypass line shall have a shutoff valve and should have an automatic proportioning or regulating device. In some installations, it may be necessary to treat the bypassed water to obtain acceptable levels of iron and/or manganese in the finished water.
6.5.b.11. Additional limitations. -- Silica gel resins shall not be used for waters having a pH above 8.4 or containing less than six (6) milligrams per liter silica and shall not be used when iron is present. When the applied water contains a chlorine residual, the cation exchange resin shall be a type that is not damaged by residual chlorine. Phenolic resin shall not be used.
6.5.b.12. Sampling taps. -- Smooth-nose sampling taps shall be provided for the collection of representative samples. The taps shall be located to provide for sampling of the softener influent, effluent and blended water. The sampling taps for the blended water shall be at least twenty (20) feet downstream from the point of blending. Petcocks are not acceptable as sampling taps. Sampling taps shall be provided on the brine tank discharge piping.
6.5.b.13. Brine and salt storage tanks.
6.5.b.13.A. Salt dissolving or brine tanks and wet salt storage tanks shall be covered and shall be corrosion-resistant.
6.5.b.13.B. The make-up water inlet shall be protected from back-siphonage. Water for filling the tank shall be distributed over the entire surface by pipes above the maximum brine level in the tank. The tanks shall be provided with an automatic declining level control system on the make-up water line.
6.5.b.13.C. Wet salt storage basins shall be equipped with manholes or hatchways for access and for direct dumping of salt from truck or rail car. Openings shall be provided with raised curbs and watertight covers having overlapping edges similar to those required for finished water reservoirs. Each cover shall be hinged on one side, and shall have locking device.
6.5.b.13.D. Overflows, where provided, shall be protected with corrosion resistant screens and shall terminate with either a turned down bend having a proper free fall discharge or a self-closing flap valve.
6.5.b.13.E. Two (2) wet salt storage tanks or compartments designed to operate independently shall be provided.
6.5.b.13.F. The salt shall be supported on graduated layers of gravel placed over a brine collection system.
6.5.b.13.G. The public water system engineer may consider alternative designs that are conducive to frequent cleaning of the wet salt storage tank.
6.5.b.14. Salt and brine storage capacity. -- Reserve salt and brine storage capacity for at least thirty (30) days of operation shall be available.
6.5.b.15. Brine pump or eductor. -- An eductor may be used to transfer brine from the brine tank to the softeners. If a pump is used, a brine measuring tank or means of metering shall be provided to obtain proper dilution.
6.5.b.16. Stabilization. -- Stabilization for corrosion control shall be provided. An alkali feeder shall be provided except when exempted by the BPH.
6.5.b.17. Waste disposal. -- Suitable disposal shall be provided for brine waste. Where the volume of spent brine is reduced, consideration may be given to using a part of the spent brine for a subsequent regeneration.
6.5.b.18. Construction materials. -- Pipes and contact materials shall be resistant to the aggressiveness of salt. Plastic and red brass are acceptable piping materials. Steel and concrete shall be coated with a non-leaching protective coating that is compatible with salt and brine.
6.5.b.19. Housing. -- Bagged salt and dry bulk salt storage shall be enclosed and separated from other operating areas in order to prevent damage to equipment.
6.6. Aeration. -- Aeration may be used to help remove offensive tastes and odors due to dissolved gases from decomposing organic matter, to reduce or remove objectionable amounts of carbon dioxide, hydrogen sulfide, etc., and to introduce oxygen to assist in iron or manganese removal, or both. The packed tower aeration process is an aeration process applicable to removal of volatile organic contaminants.
6.6.a. Natural draft aeration. -- The design shall provide: perforations in the distribution pan three-sixteenths (3/16) to one-half (½) inches in diameter, spaced one (1) to three (3) inches on centers to maintain a six (6) inch water depth, and eight (8) to ten (10) inches of inert media, such as coke or limestone that will not disintegrate due to freezing cycles; distribution of water uniformly over the top tray and discharge through a series of three (3) or more trays with separation of trays not less than twelve (12) inches; loading at a rate of one (1) to five (5) gallons per minute for each square foot of total tray area; trays with slotted, heavy wire [one half (½) inch openings] mesh or perforated bottoms and construction of durable material resistant to aggressiveness of the water and dissolved gases; protection from loss of spray water by wind carriage by enclosure with louvers sloped to the inside at an angle of approximately forty-five (45) degrees; protection from insects by twenty-four (24) mesh screen; and provisions for continuous disinfection feed shall be provided after aeration.
6.6.b. Forced or induced draft aeration. -- Forced or induced draft aeration devices shall be designed to: include a blower with a weatherproof motor in a tight housing and screened enclosure and ensure adequate counter current of air through the enclosed aerator column; exhaust air directly to the outside atmosphere; include a down-turned and twenty-four (24)-mesh screened air outlet and inlet; ensure that air introduced in the column is as free from obnoxious fumes, dust, and dirt as possible; be such that sections of the aerator can be easily reached or removed for maintenance of the interior or installed in a separate aerator room; provide loading at a rate of one (1) to five (5) gallons per minute for each square foot of total tray area; ensure that the water outlet is adequately sealed to prevent unwarranted loss of air; discharge though a series of five or more trays with separation of trays not less than six (6) inches; provide distribution of water uniformly over the top tray; be of durable material resistant to the aggressiveness of the water and dissolved gases; provide for continuous disinfection feed after aeration.
6.6.c. Spray aeration. -- The design shall provide a hydraulic head of between five (5) and twenty five (25) feet; nozzles, with the size, number, and spacing of the nozzles being dependent on the flow rate, space and amount of head available; nozzle diameter in the range of one (1) to one and a half (1.5) inches to minimize clogging; an enclosed basin to contain the spray with any openings for ventilation, etc. being protected by a twenty-four (24)-mesh screen; and for continuous disinfection feed after aeration.
6.6.d. Pressure aeration. -- Pressure aeration may be used for oxidation purposes only if the pilot plant study indicates the method is applicable; it is not acceptable for removal of dissolved gases. Filters following pressure aeration shall have adequate exhaust devices for the release of air. Pressure aeration devices shall be designed to give a thorough mixing of compressed air with the water being treated and provide screened and filtered air, free of obnoxious fumes, dust, dirt and other contaminants.
6.6.e. Packed Tower Aeration. -- Packed tower aeration (PTA) that is also known as air stripping involves passing water down through a column of packing material while pumping air counter-currently up through the packing. PTA is used for the removal of volatile organic chemicals, trihalomethanes, carbon dioxide, and radon. Generally, PTA is feasible for compounds with a Henry's Constant greater than one hundred (100) (expressed in atm mol/mol - at twelve (12) degrees C), but not normally feasible for removing compounds with a Henry's Constant less than ten (10). For values between ten (10) and one hundred (100), PTA may be feasible but shall be extensively evaluated using pilot studies. The Public Water Systems’ engineer shall discuss values for Henry's Constant with the BPH prior to final design.
6.6.e.1. Process Design.
6.6.e.1.A. Process design methods for PTA involve the determination of Henry's Constant for the contaminant, the mass transfer coefficient, air pressure drop and stripping factor. The Public Water Systems’ engineer shall provide justification to the BPH for the design parameters selected (i.e., height and diameter of the unit, air to water ratio, packing depth, surface loading rate, etc.). Pilot plant testing shall be provided. The pilot test shall evaluate a variety of loading rates and air to water ratios at the peak contaminant concentration. The public water systems’ engineer shall give special consideration to removal efficiencies when multiple contaminations occur. Where there is considerable past performance data on the contaminant to be treated and there is a concentration level similar to previous projects, the BPH may approve the process design based on use of appropriate calculations without pilot testing. The Public Water Systems’ engineer shall discuss proposals of this type with the BPH prior to submission of any permit applications.
6.6.e.1.B. The tower shall be designed to reduce contaminants to below the maximum contaminant level (MCL) and to the lowest practical level.
6.6.e.1.C. The ratio of the column diameter to packing shall be at least seven (7) to one (1) for the pilot unit and at least ten (10) to one (1) for the full scale tower. The type and size of the packing used in the full scale unit shall be the same as that used in the pilot work.
6.6.e.1.D. The minimum volumetric air to water ratio at peak water flow shall be twenty-five (25) to one (1). The maximum air to water ratio for which credit will be given is eighty (80) to one (1).
6.6.e.1.E. The design shall consider potential fouling problems from calcium carbonate, manganese and iron precipitation and from bacterial growth. It may be necessary to provide pretreatment. Disinfection capability shall be provided prior to and after PTA.
6.6.e.1.F. The effects of temperature shall be considered since a drop in water temperature can result in a drop in contaminant removal efficiency.
6.6.e.2. Materials of Construction. -- The tower may be constructed of stainless steel, concrete, aluminum, fiberglass or plastic. Uncoated carbon steel is not recommended because of corrosion. Towers constructed of light-weight materials shall be provided with adequate support to prevent damage from wind. Packing materials shall be resistant to the aggressiveness of the water, dissolved gases and cleaning materials and shall be suitable for contact with potable water.
6.6.e.3. Water Flow System. -- Water shall be distributed uniformly at the top of the tower using spray nozzles or orifice-type distributor trays that prevent short circuiting. A mist eliminator shall be provided above the water distributor system. A side wiper redistribution ring shall be provided at least every ten (10) feet to prevent water channeling along the tower wall and short circuiting. Smooth nosed sample taps shall be provided in the influent and effluent piping. The effluent sump, if provided, shall have easy access for cleaning purposes and be equipped with a drain valve. The drain shall not be connected directly to any storm or sanitary sewer. A blow-off line shall be provided in the effluent piping to allow for discharge of water and chemicals used to clean the tower. The design shall prevent freezing of the influent riser and effluent piping when the unit is not operating. If piping is buried, it shall be maintained under positive pressure. The water flow to each tower shall be metered. An overflow line shall be provided that discharges twelve (12) to fourteen (14) inches above a splash pad or drainage inlet. Proper drainage shall be provided to prevent flooding of the area.
6.6.e.4. Air Flow System. -- The air inlet to the blower and tower discharge vent shall be protected with a non-corrodible twenty-four (24) mesh downturned screen to prevent contamination from extraneous matter. The air inlet shall be in a protected location. An air flow meter shall be provided on the influent air line or an alternative method to determine the air flow shall be provided. A backup motor for the air blower shall be readily available.
6.6.e.5. Other Features that Shall Be Provided. -- The following shall be provided: a sufficient number of access ports with a minimum diameter of twenty-four (24) inches to facilitate inspection, media replacement, media cleaning and maintenance of the interior; a method of cleaning the packing material when iron, manganese, or calcium carbonate fouling may occur; tower effluent collection and pumping wells constructed to clearwell standards; provisions for extending the tower height; a BPH approved alternative supply during periods of maintenance and operation interruptions; no bypass unless specifically approved by the BPH; disinfection application points both ahead of and after the tower to control biological growth; disinfection and adequate contact time after the water has passed through the tower and prior to the distribution system; adequate packing support to allow free flow of water and to prevent deformation with deep packing heights; adequate foundation to support the tower and lateral support to prevent overturning due to wind loading; fencing and locking gate to prevent vandalism; an access ladder with safety cage for inspection of the aerator including the exhaust port and de-mister; and electrical interconnection to allow simultaneous operation and disconnect of the blower, disinfectant feeder and well pump.
6.6.e.6. Environmental Factors. -- The applicant shall contact the appropriate air quality office to determine if permits are required under the Clean Air Act. Noise control facilities shall be provided on PTA systems located in residential areas.
6.6.f. Other methods of aeration. -- Other methods of aeration may be used if applicable to the treatment needs. These methods include but are not restricted to spraying, diffused air, cascades and mechanical aeration. The treatment process shall be designed to meet the particular needs of the water to be treated and is subject to the approval of the BPH.
6.6.g. Protection of aerators. -- All aerators except those discharging to lime softening or clarification plants shall be protected from contamination by birds, insects, wind borne debris, rainfall and water draining off the exterior of the aerator.
6.6.h. Bypass. -- A bypass shall be provided for all aeration units except those installed to comply with maximum contaminant levels.
6.6.i. Corrosion control. -- The aggressiveness of the water after aeration shall be determined and corrected by additional treatment, if necessary.
6.6.j. Quality control. -- Equipment shall be provided to test for dissolved oxygen, pH and temperature to determine proper functioning of the aeration device. Equipment to test for iron, manganese and carbon dioxide should also be considered.
6.6.k. Redundancy. -- Redundant equipment shall be provided for units to comply with the Safe Drinking Water Act primary contaminants, unless otherwise approved by the BPH.
6.7. Iron and Manganese Control. -- Iron and manganese control, as used in this subsection, refers solely to treatment processes designed specifically for this purpose. The treatment process used depends upon the character of the raw water. The selection of one (1) or more treatment processes shall meet specific local conditions as determined by engineering investigations, including chemical analyses of representative samples of water to be treated, and receive the approval of the BPH. It may be necessary to operate a pilot plant in order to gather all information pertinent to the design. Consideration shall be given to adjusting the pH of the raw water to optimize the chemical reaction. Testing equipment and sampling taps shall be provided.
6.7.a. Removal by oxidation, detention and filtration.
6.7.a.1. Oxidation. -- Oxidation may be by aeration or by chemical oxidation with chlorine, potassium permanganate, sodium permanganate, ozone or chlorine dioxide.
6.7.a.2. Detention.
6.7.a.2.A. Reaction. -- A minimum detention time of thirty (30) minutes shall be provided following aeration to insure that the oxidation reactions are as complete as possible. This minimum detention may be omitted only where a pilot plant study indicates no need for detention. The detention basin shall be designed as a holding tank with no provisions for sludge collection but with sufficient baffling to prevent short circuiting.
6.7.a.2.B. Sedimentation. -- Sedimentation basins shall be provided when treating water with high iron or manganese content, or where chemical coagulation is used to reduce the load on the filters. Provisions for sludge removal shall be made.
6.7.b. Removal by the lime-soda softening process, as in subdivision 6.5.a. of this rule.
6.7.c. Removal by manganese greensand filtration. -- This process consists of a continuous or batch feed of potassium permanganate to the influent of a manganese coated media filter. Provisions shall be made to apply the permanganate as far ahead of the filter as practical and to a point immediately before the filter. Other oxidizing agents or processes such as chlorination or aeration may be used prior to the permanganate feed to reduce the cost of the chemical. An anthracite media cap of at least six inches shall be provided over manganese greensand. The normal filtration rate is three (3) gallons per minute per square foot or not to exceed the rate specified by manufacturer. The normal wash rate is eight (8) to ten (10) gallons per minute per square foot for manganese greensand and fifteen (15) to twenty (20) gallons per minute with manganese coated media. Air washing shall be provided. Smooth nosed sample taps shall be provided for the raw water, immediately ahead of filtration, at the filter effluent and at points between the anthracite media and the manganese coated media. Recommend potassium permanganate feed system have a means of automatic shut-off if overfeed occurs.
6.7.d. Removal by ion exchange. -- The ion exchange process of iron and manganese removal shall not be used for water containing more than three tenths (0.3) milligrams per liter of iron, manganese or a combination thereof. This process is not acceptable where either the raw water or wash water contains dissolved oxygen.
6.7.e. Sequestration by polyphosphates. -- The sequestration by polyphosphates process shall not be used when iron, manganese or a combination thereof exceeds one (1) milligram per liter (mg/l). The total phosphate applied shall not exceed ten (10) mg/l as PO4. Where phosphate treatment is used, satisfactory chlorine residuals shall be maintained in the distribution system. Stock phosphate solution must be kept covered and disinfected by carrying approximately ten (10) mg/l free chlorine residual unless the phosphate is not able to support bacterial growth and the phosphate is being fed from the covered shipping container. Phosphate solutions having a pH of two (2.0) or less may be exempt from this requirement by the BPH. Feeding equipment shall conform to the requirements of "Chemical Application," in subdivision 7.1.b. of this rule. Polyphosphates shall not be applied ahead of iron and manganese removal treatment. The point of application shall be prior to any aeration, oxidation or disinfection if no iron or manganese removal treatment is provided. The phosphate feed point shall be located as far ahead of the oxidant feed point as possible. Phosphate chemicals shall meet AWWA Standards and conform to ANSI/NSF Standard 60: Drinking Water Treatment Chemicals - Health Effects.
6.7.f. Sequestration by sodium silicates. -- Sodium silicate sequestration of iron and manganese is appropriate only for groundwater supplies prior to air contact. On-site pilot tests are required to determine the suitability of sodium silicate for the particular water and the minimum feed needed. Rapid oxidation of the metal ions such as by chlorine or chlorine dioxide shall accompany or closely precede the sodium silicate addition. Injection of sodium silicate more than fifteen (15) seconds after oxidation may cause a detectable loss of chemical efficiency. Dilution of feed solutions much below five per cent (5%) silica as silica dioxide shall also be avoided for the same reason. Sodium silicate addition is applicable to waters containing up to two (2) mg/l of iron, manganese or a combination thereof. Chlorine residuals shall be maintained throughout the distribution system to prevent biological breakdown of the sequestered iron. The amount of silicate added shall be limited to twenty (20) mg/l as silica dioxide, but the amount added and naturally occurring silicate shall not exceed sixty (60) mg/l as silica dioxide. Feeding equipment shall conform to the requirements of "Chemical Application," in section 7 of this rule. Sodium silicate shall not be applied ahead of iron or manganese removal treatment. Liquid sodium silicate shall meet AWWA Standard B404 and shall conform to ANSI/NSF Standard 60: Drinking Water Treatment Chemicals - Health Effects.
6.7.g. Sampling taps. -- Smooth-nosed sampling taps shall be provided for control purposes. Taps shall be located on each raw water source, each treatment unit influent and each treatment unit effluent.
6.7.h. Testing equipment shall be provided for all plants. The equipment shall have the capacity to accurately measure the iron content to a minimum of 0.1 milligrams per liter and the manganese content to a minimum of 0.05 milligrams per liter. Where polyphosphate sequestration is practiced, appropriate phosphate testing equipment shall be provided.
6.8. Fluoridation. -- Sodium fluoride, sodium silicofluoride and hydrofluosilicic acid shall conform to the applicable AWWA standards and shall conform to ANSI/NSF Standard 60: Drinking Water Treatment Chemicals - Health Effects. Other fluoride compounds that may be available shall be approved by the BPH. The proposed method of fluoride feed shall be approved by the BPH prior to preparation of final plans and specifications.
6.8.a. Fluoride compound storage. -- Fluoride chemicals shall be isolated from other chemicals to prevent contamination. Compounds shall be stored in covered or unopened shipping containers and shall be stored inside a building. Storage of hydrofluosilicic acid shall be in sealed carboys unless the treatment plant is designed with bulk storage tanks. While being used, the unsealed storage units for hydrofluosilicic acid shall be vented to the atmosphere at a point outside any building. Bags, fiber drums and deldrums shall be stored on pallets.
6.8.b. Chemical feed equipment and methods. -- In addition to the requirements in "Chemical Application," in section 7 of this rule, fluoride feed equipment shall meet the following requirements: scales, loss-of-weight recorders or liquid level indicators, as appropriate, accurate to within five percent (5%) of the average daily change in reading shall be provided for chemical feeds; feeders shall be accurate to within five percent (5%) of any desired feed rate; the fluoride compound shall be fed by a fluoride saturator, volumetric, gravimetric, or hydrofluosilicic acid fifteen (15) gallon carboy or fifty-five (55) gallon drum only (solution tanks are not permitted, exclusive of saturators); fluoride compound shall be added last, either directly into the clearwell or into the plant discharge line; the point of application for hydrofluosilicic acid or sodium fluoride, if into a horizontal pipe, shall be forty-five (45) degrees from the bottom of the pipe with the injector protruding into the pipe one-third (1/3) of the pipe diameter; a fluoride solution shall be applied by a positive displacement pump having a stroke rate not less than twenty (20) strokes per minute; anti-siphon devices shall be provided for all fluoride lines and dilution water lines; a device to measure the flow of water to be treated is required; water used for sodium fluoride saturated solution shall be softened if hardness exceeds seventy-five (75) mg/l as calcium carbonate; fluoride solutions shall not be injected to a point of negative pressure; the electrical outlet used for the fluoride feed pump shall have a nonstandard receptacle, unless it would void the pump warranty, and shall be interconnected with the well or high service pump; and saturators shall be of the upflow type and be provided with a meter and backflow protection on the makeup water line. Consideration shall be given to providing a separate room for florosilicic acid storage and feed.
6.8.c. Secondary controls. -- Secondary control systems for fluoride chemical feed devices may be required by the BPH as a means of reducing the possibility for overfeed; these may include flow or pressure switches, break boxes or other devices.
6.8.d. Protective equipment. -- Protective equipment as recommended by the compound manufacturer shall be provided for operators handling fluoride compounds. Deluge showers and eye wash devices shall be provided at all fluorosilicic acid installations.
6.8.e. Dust control. -- Provision shall be made for the transfer of dry fluoride compounds from shipping containers to storage bins or hoppers in such a way as to minimize the quantity of fluoride dust that may enter the room in which the equipment is installed. The enclosure shall be provided with an exhaust fan and dust filter that place the hopper under a negative pressure. Air exhausted from fluoride handling equipment shall discharge through a dust filter to the atmosphere outside of the building. Provision shall be made for disposing of empty bags, drums or barrels in a manner that minimizes exposure to fluoride dusts. A floor drain shall be provided to facilitate the hosing of floors.
6.8.f. Testing equipment. -- Equipment shall be provided for measuring the quantity of fluoride in the water. The equipment is subject to the approval of the BPH.
6.9. Stabilization. -- Water that is unstable due either to natural causes or to subsequent treatment shall be stabilized.
6.9.a. Carbon dioxide addition. -- Recarbonation basin design shall provide a total detention time of twenty (20) minutes. Two compartments, with a depth that provides a diffuser submergence of not less than 7.5 feet nor greater submergence than recommended by the manufacturer are required. One compartment shall be a mixing compartment having a detention time of at least three minutes and the second compartment shall be a reaction compartment. The practice of on-site generation of carbon dioxide is discouraged. Where liquid carbon dioxide is used, adequate precautions shall be taken to prevent carbon dioxide from entering the plant from the recarbonation process. Consideration should be given to the installation of a carbon dioxide alarm system with light and audio warning, especially in low areas. Recarbonation tanks shall be located outside or be sealed and vented to the outside with adequate seals and adequate urge flow of air to ensure worker safety. Provisions shall be made for draining the carbonation basin and removing sludge.
6.9.b. Acid addition. -- Feed equipment shall conform to "Chemical Application" subdivision 7.1.b. Adequate precautions shall be taken for operator safety, such as not adding water to the concentrated acid.
6.9.c. Phosphates. -- The feeding of phosphates may be applicable for sequestering calcium, corrosion control, and in conjunction with alkali feed following ion exchange softening. Feed equipment shall conform to "Chemical Application," subdivision 7.1.b of this rule. Phosphate shall meet AWWA standards and shall conform to ANSI/NSF Standard 60: Drinking Water Treatment Chemicals - Health Effects. Stock phosphate solution shall be kept covered and disinfected by carrying approximately ten (10) milligrams per liter free chlorine residual unless the phosphate is not able to support bacterial growth and the phosphate is being fed from the covered shipping container. Phosphate solutions having a pH of two (2) or less may be exempted from this requirement by the BPH. Satisfactory chlorine residuals shall be maintained in the distribution system when phosphates are used.
6.9.d. "Split treatment". -- Under some conditions, a lime-softening water treatment plant may be designed using "split treatment" in which raw water is blended with lime-softened water to partially stabilize the water prior to secondary clarification and filtration. Treatment plants designed to utilize "split treatment" shall also contain facilities for further stabilization by other methods.
6.9.e. Alkali feed. -- Water with low alkalinity or pH should be treated with an alkali chemical.
6.9.f. Carbon dioxide reduction by aeration. -- The carbon dioxide content of an aggressive water may be reduced by aeration.
6.9.g. Other treatment. -- Other treatment for controlling corrosive waters by the use of calcium hydroxide, sodium silicate and sodium bicarbonate may be used where necessary. Any proprietary compound shall receive the specific approval of the BPH before use.
6.9.h. Water unstable due to biochemical action in distribution system. -- Unstable water resulting from the bacterial decomposition of organic matter in water (especially in dead end mains), the biochemical action within tubercles, and the reduction of sulfates to sulfides shall be prevented by the maintenance of a free and/or combined chlorine residual throughout the distribution system.
6.9.i. Control. -- Laboratory equipment shall be provided for determining the effectiveness of stabilization treatment.
6.10. Taste and Odor Control. -- Provision shall be made for the control of taste and odor at all surface water treatment plants. Chemicals shall be added sufficiently ahead of other treatment processes to assure adequate contact time for effective and economical use of the chemicals. Where severe taste and odor problems are encountered, in-plant or pilot plant, or both, studies are required.
6.10.a. Flexibility. -- Plants treating water that is known to have taste and odor problems shall be provided with equipment that makes several of the control processes available so that the operator has flexibility in operation.
6.10.b. Chlorination. -- Chlorination can be used for the removal of some objectionable odors. Adequate contact time shall be provided to complete the chemical reactions involved. Excessive potential disinfection byproduct production shall be investigated by adequate bench-scale testing prior to the design.
6.10.c. Chlorine dioxide. -- Chlorine dioxide has been generally recognized as a treatment for tastes caused by industrial wastes, such as phenols. Chlorine dioxide may be used in the treatment of any taste and odor that is treatable by an oxidizing compound. Provisions shall be made for proper storing and handling of the sodium chlorite, so as to eliminate any danger of explosion.
6.10.d. Powdered activated carbon. -- Powdered activated carbon shall be added as early as possible in the treatment process to provide maximum contact time. Flexibility to allow the addition of carbon at several points is preferred. Activated carbon shall not be applied near the point of chlorine application or any other oxidant. The carbon can be added as a pre-mixed slurry or by means of a dry-feed machine as long as the carbon is properly wetted. Continuous agitation or re-suspension equipment is necessary to keep the carbon from depositing in the slurry storage tank. Provision shall be made for adequate dust control. The required rate of feed of carbon in a water treatment plant depends upon the tastes and odors involved, but provision shall be made for adding from 0.1 milligrams per liter to at least forty (40) milligrams per liter. Powdered activated carbon shall be handled as a potentially combustible material. It shall be stored in a building or compartment as nearly fireproof as possible. Other chemicals shall not be stored in the same compartment. A separate room shall be provided for carbon feed installations. Carbon feeder rooms shall be equipped with explosion-proof electrical outlets, lights and motors.
6.10.e. Granular activated carbon. -- Replacement of anthracite with GAC may be considered as a control measure for geosmin and methyl isoborneol (MIB) taste and odors from algae blooms. Demonstration studies may be required by the BPH.
6.10.f. Copper sulfate and other copper compounds. -- Continuous or periodic treatment of water with copper compounds to kill algae or other growths shall be controlled to prevent copper in excess of one (1) milligram per liter as copper in the plant effluent or distribution system. Care shall be taken to assure an even distribution within the treatment area.
6.10.g. Aeration. -- See "Aeration," subsection 6.6 of this rule.
6.10.h. Potassium permanganate. -- Application of potassium permanganate may be considered, providing the treatment shall be designed so that the products of the reaction are not visible in the finished water.
6.10.i. Ozone. -- Ozonation may be used as a means of taste and odor control. Adequate contact time shall be provided to complete the chemical reactions involved. Ozone is generally more desirable for treating water with high threshold odors.
6.10.j. Other methods. -- The decision to use any other methods of taste and odor control shall be made only after careful laboratory or pilot plant, or both, tests and in consultation with the BPH.
6.11. Microscreening. -- A microscreen is a mechanical supplement of treatment capable of removing suspended matter from the water by straining. It may be used to reduce nuisance organisms and organic loadings. It shall not be used in place of filtration, when filtration is necessary to provide satisfactory water nor used in place of coagulation in the preparation of water for filtration.
6.11.a. Design. -- Design shall give due consideration to: the nature of the suspended matter to be removed corrosiveness of the water, the effect of chlorination, when required as pre-treatment; the duplication of units for continuous operation during equipment maintenance: and automated backflushing operation when used in conjunction with microfiltration treatment. Design shall provide a durable, corrosion-resistant screen, by-pass arrangements, protection against back-siphonage when potable water is used for washing, and proper disposal of wash waters.
6.12. Waste Handling and Disposal. -- Provisions shall be made for proper disposal of water treatment plant waste such as sanitary waste, laboratory waste, clarification sludge, softening sludge, iron sludge, filter backwash water, and brines. All waste discharges are governed by West Virginia Department of Environmental Protection (WVDEP) requirements. The requirements under this rule shall be considered minimum requirements as WVDEP may have more stringent requirements. In locating waste disposal facilities, due consideration shall be given to preventing potential contamination of the water supply. Alternative methods of water treatment and chemical use shall be considered as a means of reducing waste volumes and the associated handling and disposal problems.
6.12.a. Sanitary waste. -- The sanitary waste from water treatment plants, pumping stations, and other waterworks installations shall receive treatment. Waste from these facilities shall be discharged directly to a sanitary sewer system, when available and feasible, to an adequate on-site waste treatment facility approved by the County Health Department or to a treatment system approved by the BPH.
6.12.b. Brine waste. -- Waste from ion exchange plants, demineralization plants, or other plants that produce a brine, may be disposed of by controlled discharge to a stream if adequate dilution is available. Surface water quality requirements of the WVDEP control the rate of discharge. Except when discharging to large waterways, a holding tank of sufficient size shall be provided to allow the brine to be discharged over a twenty-four (24) hour period. Where discharging to a sanitary sewer, a holding tank may be required to prevent the overloading of the sewer or interfering with the waste treatment processes. The effect of brine discharge to sewage lagoons may depend on the rate of evaporation from lagoons.
6.12.c. Precipitative softening sludge. -- Sludge from plants using precipitative softening water varies in quantity and in chemical characteristics depending on the softening process and the chemical characteristics of the water being softened. Recent studies show that the quantity of sludge produced is much larger than indicated by stoichiometric calculations. Methods of treatment and disposal are as follows:
6.12.c.1. Lagoons. -- Temporary lagoons that are cleaned periodically shall be designed on the basis of 0.7 acres per million gallons per day per one hundred (100) milligrams per liter of hardness removed based on usable lagoon depth of five feet. This shall provide about 2 years storage. At least two (2) but preferably more lagoons shall be provided in order to give flexibility in operation. An acceptable means of final sludge disposal shall be provided. Provisions shall be made for convenient cleaning. Permanent lagoons shall have a volume of at least four (4) times that for temporary lagoons. The design of both temporary lagoons and permanent lagoons shall provide for: locations free from flooding; when necessary, dikes, deflecting gutters or other means of diverting surface water so that it does not flow into the lagoons; a minimum usable depth of five (5) feet; adequate freeboard of at least two (2) feet; an adjustable decanting device; an effluent sampling point; safety provisions; and parallel operation.
6.12.c.2. Land Application. -- The application of liquid lime sludge or dewatered sludge to farm land shall be considered as a method of ultimate disposal. Approval from the WVDEP shall be obtained.
6.12.c.3. Sanitary Sewers. -- Discharge of lime sludge to sanitary sewers is only permitted when the sewerage system has the capability to adequately handle the lime sludge.
6.12.c.4. Mixing. -- Mixing of lime sludge with activated sludge waste may be considered as a means of co-disposal.
6.12.c.5. Landfills. -- Disposal at a landfill may be done as either a solid or liquid if the landfill can accept such waste, depending on WVDEP requirements.
6.12.c.6. Mechanical Dewatering. -- Mechanical dewatering of sludge may be considered. Pilot studies on a particular plant waste are recommended. The BPH may require operational data from similar water treatment facilities treating similar raw water and require performance guaranteed specifications for the mechanical equipment.
6.12.c.7. Calcination. -- Calcination of sludge may be considered. Pilot studies on a particular plant waste are recommended. The BPH may require operational data from similar water treatment facilities treating similar raw water and require performance guaranteed specifications for the mechanical equipment.
6.12.c.8. Drying Beds. -- Lime sludge drying beds are not recommended.
6.12.d. Alum sludge. -- Lagooning may be used as a method of handling alum sludge. Lagoon size may be calculated using total chemicals used plus a factor for turbidity. Mechanical concentration may be considered. A pilot plant study is required before the design of a mechanical dewatering installation. Freezing changes the nature of alum sludge so that it can be used for fill. Acid treatment of sludge for alum recovery may be a possible alternative. Alum sludge may be discharged to a sanitary sewer; however, initiation of this practice depends on obtaining approval from the owner of the sewerage system as well as from the BPH before final designs are made. Lagoons shall be designed to produce an effluent satisfactory to the WVDEP and shall provide for: locations free from flooding; where necessary, dikes, deflecting gutters or other means of diverting surface water so that it does not flow into the lagoon; a minimum usable depth of five feet; freeboard of at least two (2) feet; an adjustable decanting device; an effluent sampling point; safety provisions; and a minimum two (2) cells, each with appropriate inlet/outlet structures to facilitate independent filling/dewatering operations. Mechanical dewatering shall be preceded by sludge concentration and chemical pre-treatment. Alum sludge may be disposed of by land application with approval from the WVDEP.
6.12.e. "Red water" waste. -- Waste filter wash water from iron and manganese removal plants can be disposed of as follows:
6.12.e.1. Sand filters. -- Sand filters shall have the following features:
6.12.e.1.A. Total filter area, regardless of the volume of water to be handled, shall be no less than one hundred (100) square feet. Unless the filter is small enough to be cleaned and returned to service in one (1) day, two (2) or more cells are required;
6.12.e.1.B. The "red water" filter shall have sufficient capacity to contain, above the level of the sand, the entire volume of wash water produced by washing all of the production filters in the plant, unless the production filters are washed on a rotating schedule and the flow through the production filters is regulated by true rate of flow controllers. Then sufficient volume shall be provided to properly dispose of the wash water involved;
6.12.e.1.C. Sufficient filter surface area shall be provided so that, during any one (1) filtration cycle, no more than two (2) feet of backwash water may accumulate over the sand surface;
6.12.e.1.D. The filter shall not be subject to flooding by surface runoff or flood waters. Finished grade elevation shall be established to facilitate maintenance, cleaning and removal of surface sand as required. Flash boards or other non-watertight devices shall not be used in the construction of filter side walls;
6.12.e.1.E. The filter media shall consist of a minimum of twelve (12) inches of sand, three (3) to four (4) inches of supporting small gravel or torpedo sand and nine (9) inches of gravel in graded layers. All sand and gravel shall be washed to remove fines;
6.12.e.1.F. Filter sand shall have an effective size of 0.3 to 0.5 mm and a uniformity coefficient not to exceed 3.5. The use of larger sized sands shall be justified by the designing engineer to the satisfaction of the BPH;
6.12.e.1.G. The filter shall be provided with an adequate under-drainage collection system to permit satisfactory discharge of filtrate;
6.12.e.1.H. Provision shall be made for the sampling of the filter effluent;
6.12.e.1.I. Overflow devices from "red water" filters shall not be permitted;
6.12.e.1.J. Where freezing is a problem, provisions shall be made for covering the filters during the winter months; and
6.12.e.1.K. "Red water" filters shall comply with the common wall provisions that pertain to the possibility of contamination of finished water with unsafe water. The BPH shall be contacted for approval of any arrangement where a separate structure is not provided.
6.12.e.2. Lagoons. -- Lagoons shall have the following features: be designed with volume ten (10) times the total quantity of wash water discharged during any twenty-four (24) hour period; a minimum usable depth of three (3) feet, length four (4) times width, and the width at least three (3) times the depth, as measured at the operating water level; an outlet at the end opposite the inlet; a weir overflow device at the outlet end with weir length equal to or greater than depth; and velocity dissipated at the inlet end.
6.12.e.3. Discharge to community sanitary sewer. -- "Red water" may be discharged to a community sewer; however, approval of this method depends on obtaining approval from the owner of the sewerage system as well as from the BPH before final designs are made. A holding tank is recommended to prevent overloading the sewers. Design shall prevent cross connections and there shall be no common walls between potable and non-potable water.
6.12.e.4. Recycling "Red Water" waste. -- Recycling of supernatant or filtrate from "red water" waste treatment facilities to the head end of an iron removal plant is not allowed except as approved by the BPH.
6.12.e.5. Discharge to surface water. -- Plants shall have a permit from the WVDEP for disposal of backwash water into surface water.
6.12.f. Waste filter wash water. -- Waste filter wash water from surface water treatment or lime softening plants shall have suspended solids reduced to a level acceptable to the WVDEP before being discharged. Many plants have constructed holding facilities and return this water to the inlet end of the plant. The holding facility shall be of such a size that it contains the anticipated volume of waste wash water produced by the plant when operating at design capacity. A plant that has two (2) filters shall have a holding facility that contains the total waste wash from both filters calculated by using a fifteen (15) minute wash at twenty (20) gallons per minute per square foot. In plants with more filters, the size of the holding facilities depends on the anticipated hours of operation. It is required that waste filter wash water be returned at a rate of less than ten percent (10%) of the raw water influent rate. Filter backwash water shall not be recycled when the raw water contains excessive algae, when finished water taste and odor problems are encountered, or when disinfection byproduct levels in the distribution system may exceed allowable levels. Particular attention must be given to the presence of protozoans such as Giardia and Cryptosporidium concentrating in the waste water stream. Water utilities may need to treat filter waste water prior to recycling to reduce pathogen population and improve coagulation or avoid reclaiming filter wash water given the increased risk to treated water quality.
6.12.g. Radioactive materials. -- Radioactive materials include, but are not limited to, granulated activated carbon (GAC); ion-exchange regeneration waste from radium removal; and manganese greensand backwash solids from manganese removal systems, precipitative softening sludge, and reverse osmosis concentrates where radiological constituents are present. The buildup of radioactive decay products of radon shall be considered, and adequate shielding and safeguards shall be provided for operators and visitors. These materials may require disposal as radioactive waste in accordance with Nuclear Regulatory Commission regulations. Approval shall be obtained from the WVDEP prior to disposal of radioactive materials.
6.12.h. Arsenic waste residuals. -- Arsenic-bearing wastes from an arsenic treatment facility may be considered hazardous. Under the Resource Conservation and Recovery Act (RCRA), a residual from an arsenic water treatment facility is defined as being hazardous waste if it exhibits a Toxicity Characteristic Leaching Procedure (TCLP) result of 5.0 mg/l. Approval shall be obtained from the WVDEP prior to disposal of arsenic waste residuals.
W. Va. Code R. § 64-77-7 Chemical Application
7.1. General. -- No chemicals shall be applied to treat drinking waters unless specifically approved by the BPH.
7.1.a. Plans and specifications. -- Plans and specifications shall be submitted to the BPH for review and approval and shall include: descriptions of feed equipment, including maximum and minimum feed ranges; the location of feeders, piping layout and points of application; storage and handling facilities; specifications for chemicals to be used; operating and control procedures including proposed application rates; the descriptions of testing equipment and procedures; system including all tanks with capacities, (with drains, overflows, and vents), feeders, transfer pumps, connecting piping, valves, points of application, backflow prevention devices, air gaps, secondary containment and safety eye washes and showers.
7.1.b. Chemical application. -- Chemicals shall be applied to the water at such points and by such means as to assure maximum efficiency of treatment, assure maximum safety to consumers, provide maximum safety to operators, assure satisfactory mixing of the chemicals with the water, provide maximum flexibility of operation through various points of application, when appropriate, and prevent backflow or back-siphonage between multiple points of feed through common manifolds.
7.1.c. General equipment design. -- General equipment design shall be such that: feeders are able to supply, at all times, the necessary amounts of chemicals at an accurate rate, throughout the range of feed; chemical-contact materials and surfaces are resistant to the aggressiveness of the chemical solution; corrosive chemicals are introduced in such a manner as to minimize potential for corrosion; chemicals that are incompatible are not stored or handled together; all chemicals are conducted from the feeder to the point of application in separate conduits; chemical feeders are as near as practical to the feed point; chemical feeders and pumps operate at no lower than twenty per cent (20%) of the feed range unless two (2) fully independent adjustment mechanisms such as pump pulse rate and stroke length are fitted when the pump shall operate at no lower than ten (10) percent of the rated maximum; and chemicals are fed by gravity where practical.
7.1.d. Chemical information. -- For each chemical the information shall include: specifications for the chemical to be used; purpose of the chemical; proposed minimum non-zero, average and maximum dosages, solution strength or purity (as applicable), and specific gravity or bulk density; and method for independent calculation of amount fed daily.
7.2. Feed Equipment.
7.2.a. Number of feeders. -- Where chemical feed is necessary for the protection of the supply, such as chlorination, coagulation or other essential processes, the standby unit or a combination of units of sufficient capacity shall be available to replace the largest unit when it is out of service. The standby unit or a combination of units of sufficient capacity shall be available to replace the largest unit during shut-downs. A separate feeder shall be used for each chemical applied. Spare parts shall be available for all equipment to replace parts that are subject to wear and damage.
7.2.b. Control. -- Feeders may be manually or automatically controlled, with automatic controls designed to allow override by manual controls. Process shall be manually started following shutdown, unless otherwise approved by the BPH. At automatically operated facilities, chemical feeders shall be electrically interconnected with the well or service pump. Chemical feed rates shall be proportional to the flow stream being dosed. A means to measure the flow stream shall be provided in order to determine chemical feed rates. Provisions shall be made for measuring the quantities of chemicals used. Automatic chemical dose or residual analyzers may be approved by the BPH for use and shall provide alarms for critical values and recording charts.
7.2.b.1. Weighing scales. -- Weighing scales shall be provided for weighing cylinders at all plants utilizing chlorine gas; shall be required for fluoride solution fed from supply drums or carboys; should provide for volumetric dry chemical feeders; shall be capable of providing reasonable precision in relation to average daily dose. Where conditions warrant, for example with rapidly fluctuating intake turbidity, coagulant and coagulant aid addition may be made according to turbidity, streaming current or other sensed parameter.
7.2.c. Dry chemical feeders. -- Dry chemical feeders shall measure chemicals volumetrically or gravimetrically, provide adequate solution/slurry water and agitation of the chemical at the point of placing solution/slurry, completely enclose chemicals to prevent emission of dust to the operating room.
7.2.d. Positive displacement solution pumps. -- Positive displacement type solution feed pumps shall: be used to feed liquid chemicals but shall not be used to feed chemical slurries; be capable of operating at the required maximum rate against the maximum head conditions found at the point of injection; be provided with calibration tubes or mass flow monitors which allow for direct physical measurement of actual feed rates; and have a pressure relief valve on the pump discharge line.
7.2.e. Liquid chemical feeders. -- Siphon control -- Liquid chemical feeders shall be such that chemical solutions cannot be siphoned into the water supply by assuring discharge at a point of positive pressure or by providing vacuum relief, a suitable air gap, or anti-sipon device, or other suitable means or combinations as necessary.
7.2.f. Cross-connection control. -- Cross-connection control shall be provided to assure that the service water lines discharging to liquid storage tanks are properly protected from backflow as required by the BPH. Design shall prevent chemical solutions or slurries from being siphoned through solution feeders into the water supply, and no direct connection shall exist between any sewer and a drain or overflow from the feeder, solution chamber or tank by providing that all drains terminate at least six (6) inches or two (2) pipe diameters, whichever is greater, above the overflow rim of a receiving sump, conduit or waste receptacle.
7.2.g. Chemical feed equipment location. -- Chemical feed equipment shall: be located in a separate room to reduce hazards and dust problems; be conveniently located near points of application to minimize length of feed lines; be readily accessible for servicing, repair, and observation of operation including cleanouts; be located such that the flow to the rapid mix is by gravity, except in case of in-line static mixers; be located with protective curbing so that chemicals from equipment failure, spillage or accidental drainage shall not enter the water in conduits, treatment or storage basins; and have floor drains to facilitate area cleaning.
7.2.h. In-Plant water supply. -- The in-plant water supply shall be: only from a safe, source approved by the BPH, ample in quantity and adequate in pressure; provided with means for measurement when preparing specific solution concentrations by dilution; properly treated for hardness, when necessary; and properly protected against backflow as approved by the BPH.
7.2.i. Storage of chemicals. -- Space shall be provided for at least thirty (30) days of chemical supply, the convenient and efficient handling of chemicals, dry storage conditions, and a minimum storage volume of 1½ truckloads where purchase is by truckload lots. Storage tanks and pipelines for liquid chemicals shall be specific to the chemicals and not for alternates. Where possible, connectors for each liquid chemical shall be different and distinctly marked. Chemicals shall be stored in covered or unopened shipping containers, unless the chemical is transferred into a storage unit approved by the BPH. Liquid chemical storage tanks shall have a liquid level indicator, have an overflow and a receiving basin or drain capable of containing accidental spills or overflows, provide for sufficient containment volume to prevent accidental discharge in the event of failure of the largest tank.
7.2.j. Bulk liquid storage tanks. -- A means shall be provided in a solution tank to maintain a uniform strength of solution. Continuous agitation shall be provided to maintain slurries in suspension. A means to assure continuity of chemical supply while servicing a liquid storage tank shall be provided. Means shall be provided to measure the liquid level in the tank. Liquid storage tanks shall be kept covered. Large liquid storage tanks with access openings shall have the openings curbed and fitted with overhanging covers. Subsurface locations for solution tanks shall be free from sources of possible contamination and assure positive drainage for groundwater, accumulated water, chemical spills and overflows. Overflow pipes, when provided, shall be turned downward, with the end screened, have a free fall discharge, and be located where noticeable. Liquid storage tanks shall be vented, but not through vents in common with day tanks. Acid storage tanks shall be vented to the outside atmosphere. Each tank shall be provided with a valved drain and be protected against cross-connections. Liquid storage tanks shall be located with protective curbing so that chemicals from equipment failure, spillage or accidental drainage shall not enter the water in conduits, treatment or storage basins. Secondary containment volumes shall be able to hold the volume of the largest storage tank. Piping shall be designed to minimize or contain chemical spills in the event of pipe ruptures.
7.2.k. Day tanks. -- Day tanks shall be provided where bulk storage of liquid chemical is provided, however, the BPH may allow chemicals to be fed directly from shipping containers no larger than fifty-five (55) gallons. Day tanks shall meet all the requirements of bulk liquid storage tanks, except that shipping containers do not require overflow pipes and drains. Day tanks shall hold no more than a thirty (30) hour supply, but no less than a one (1) day of operation supply at design flow. Day tanks shall be scale-mounted or have a calibrated gauge painted or mounted on the side if liquid level can be observed in a gauge tube, manometer or through translucent sidewalls of the tank. In opaque tanks, a gauge rod extending above a reference point at the top of the tank, attached to a float, may be used. Except for fluosilicic acid, hand pumps may be provided for transfer from a shipping container. A tip rack may be used to permit withdrawal into a bucket from a spigot. Where motor-driven transfer pumps are provided, a liquid level limit switch shall be provided. A means which is consistent with the nature of the chemical solution shall be provided to maintain uniform chemical strength in a day tank. Continuous agitation shall be provided to maintain chemical slurries in suspension. Tanks and tank refilling line entry points shall be clearly labeled with the name of the chemical contained. Filling of day tanks shall not be automated, unless authorized by the BPH.
7.2.l. Feed lines. -- Feed lines: shall be as short as possible, and of durable, corrosion-resistant material, easily accessible throughout the entire length, protected against freezing, and readily cleaned; shall slope upward from the chemical source to the feeder when conveying gases; shall be designed consistent with scale-forming or solids depositing properties of the water, chemical, solution or mixtures conveyed; and shall be color coded and labeled.
7.2.m. Handling. -- Carts, elevators and other appropriate means shall be provided for lifting chemical containers to minimize excessive lifting by operators. Provisions shall be made for disposing of empty bags, drums or barrels by an approved procedure that minimizes exposure to dusts. Provision shall be made for the proper transfer of dry chemicals from shipping containers to storage bins or hoppers in such a way as to minimize the quantity of dust that may enter the room in which the equipment is installed. Control shall be provided by use of vacuum pneumatic equipment or closed conveyor systems; facilities for emptying shipping containers in special enclosures; or for exhaust fans and dust filters that put the hoppers or bins under negative pressure. Provision shall be made for measuring quantities of chemicals used to prepare feed solutions.
7.2.n. Housing. -- Floor surfaces shall be smooth and impervious, slip-proof and well drained. Vents from feeders, storage facilities and equipment exhaust shall discharge to the outside atmosphere above grade and remote from air intakes and doors.
7.3. Chemicals.
7.3.a. Shipping containers. -- Chemical shipping containers shall be fully labeled to include the chemical’s name, purity and concentration and supplier name and address.
7.3.b. Specifications. -- Chemicals shall meet AWWA specifications and shall conform to ANSI/NSF Standard 60: Drinking Water Treatment Chemicals - Health Effects where applicable.
7.3.c. Assay. -- Provisions may be required for the assay of chemicals delivered.
7.4. Operator Safety.
7.4.a. Ventilation. -- Special provisions shall be made for ventilation of chlorine feed and storage rooms.
7.4.b. Respiratory protection equipment. -- Respiratory protection equipment, meeting the requirements of the National Institute for Occupational Safety and Health (NIOSH), shall be available where chlorine gas is handled and shall be stored at a convenient location but not inside any room where chlorine is used or stored. The units shall use compressed air, have at least a thirty (30) minute capacity and be compatible with or exactly the same as units used by the fire department responsible for the plant.
7.4.c. Chlorine leak detection. -- A bottle of ammonium hydroxide, fifty-six percent (56%) ammonia solution, shall be available for chlorine leak detection. Where ton containers are used, a leak repair kit approved by the Chlorine Institute shall be provided. Where pressurized chlorine gas is present, continuous chlorine leak detection equipment is required and shall be equipped with both an audible alarm and a warning light.
7.4.d. Protective equipment. -- The public water system shall provide each operator at least one (1) pair of rubber gloves, a dust respirator of a type meeting NIOSH requirements for toxic dusts, an apron or other protective clothing and goggles or face mask. A deluge shower and eye-washing device shall be installed where strong acids and alkalis are used or stored. A water holding tank that allows water to come to room temperature shall be installed in the water line feeding the deluge shower and eye-washing device. Other methods of water tempering may be considered on an individual basis. Other protective equipment shall be provided as necessary.
7.5. Specific Chemicals.
7.5.a. Chlorine gas. -- Chlorine gas feed and storage shall be enclosed, sealed and separated from other operating areas. The chlorine room shall be provided with a shatter resistant inspection window installed in an interior wall, constructed in such a manner that all openings between the chlorine room and the remainder of the plant are sealed and provided with doors equipped with panic hardware assuring a ready means of exit and opening outward only to the building exterior.
7.5.a.1. Full and empty cylinders of chlorine gas shall be isolated from operating areas, restrained in position to prevent upset, stored in rooms separate from ammonia storage and stored in areas not in direct sunlight or exposed to excessive heat.
7.5.a.2. Where chlorine gas is used, adequate housing shall be provided for the chlorination equipment and for storing chlorine. The room shall be constructed to provide the following: a ventilating fan designed specifically to handle chlorine gas with a capacity that provides one complete air change per minute when the room is occupied; the ventilating fan shall take suction near the floor as far as practical from the door and air inlet, with the point of discharge located so as not to contaminate air inlets or entrance doors to any rooms or structures; air inlets shall be through corrosion resistant louvers near the ceiling; and louvers for chlorine room air intake and exhaust shall facilitate airtight closure. Separate switches for the fan and lights shall be located outside of the chlorine room and at the inspection window. Outside switches shall be protected from vandalism. A signal light indicating fan operation shall be provided at each entrance when the fan can be controlled from more than one point. Vents from feeders and storage shall discharge to the outside atmosphere, above grade. The room location shall be on the prevailing downwind side of the building away from entrances, windows, louvers, walkways, etc. Floor drains are discouraged. Where provided, the floor drains shall discharge to the outside of the building and shall not be connected to other internal or external drainage systems. Where located near residential or developed areas and deemed necessary by the BPH, provision shall be made to chemically neutralize chlorine gas before discharge from the water treatment plant building into the environment. Such equipment shall be designed as part of the chlorine gas storage and feed areas to automatically engage in the event of any measured chlorine release. The equipment shall be sized to treat the entire contents of the largest storage container on site.
7.5.a.3. Chlorinator rooms shall be heated to sixty (60) degrees F and be protected from excessive heat. Cylinders and gas lines shall be protected from temperatures above that of the feed equipment.
7.5.a.4. Pressurized chlorine feed lines shall not carry chlorine gas beyond the chlorinator room.
7.5.b. Acids and caustics. -- Acids and caustics shall be kept in closed corrosion-resistant shipping containers or bulk liquid storage tanks with the contents identified by signs or placards. Acids and caustics shall not be handled in open vessels but shall be pumped in undiluted form from original containers through suitable hose to the point of treatment or to a covered day tank.
7.5.c. Sodium chlorite for chlorine dioxide generation. -- Proposals for the storage and use of sodium chlorite shall be approved by the BPH prior to the preparation of final plans and specifications. Provisions shall be made for proper storage and handling of sodium chlorite to eliminate any danger of fire or explosion associated with its powerful oxidizing nature.
7.5.c.1. Storage. -- Sodium chlorite shall be stored by itself in a separate room and preferably shall be stored in an outside building detached from the water treatment facility. It shall be stored away from organic materials that would react violently with sodium chlorite. The storage structures shall be constructed of noncombustible materials. If the storage structure is located in an area where a fire may occur, water shall be available to keep the sodium chlorite area cool enough to prevent decomposition from heat and the resultant explosive conditions.
7.5.c.2. Handling. -- Care shall be taken to prevent spillage. An emergency plan of operation shall be available for the clean-up of any spillage. Storage drums shall be thoroughly flushed prior to being recycled or disposed.
7.5.c.3. Feeders. -- Positive displacement feeders shall be provided. Tubing for conveying sodium chlorite or chlorine dioxide solutions shall be Type 1 PVC, polyethylene or materials recommended by the manufacturer. Chemical feeders may be installed in gas chlorine rooms if sufficient space is provided for facilities meeting the chlorine room requirements. Feed lines shall be installed in a manner to prevent formation of gas pockets and shall terminate at a point of positive pressure. Check valves shall be provided to prevent the backflow of chlorine into the sodium chlorite line.
7.5.d. Sodium Hypochlorite. -- Storage and handling procedures shall be arranged to minimize the slow natural decomposition process of sodium hypochlorite either by contamination or by exposure to more extreme storage conditions. In addition, feed rates shall be regularly adjusted to compensate for this progressive loss in chlorine content.
7.5.d.1. Storage. -- Sodium hypochlorite shall be stored in the original container or in sodium hypochlorite compatible bulk liquid storage tanks. Storage containers or tanks shall be located out of sunlight in a cool area and shall be vented to the outside of the building. Whenever feasible, stored sodium hypochlorite shall be pumped undiluted to the point of addition. Where dilution is unavoidable, deionized or softened water should be used. Storage areas, tanks, and pipe work shall be designed to avoid the possibility of uncontrolled discharges and a sufficient amount of appropriately selected spill absorbent shall be stored on-site.
7.5.d.2. Feeders. -- Positive displacement pumps with sodium hypochlorite compatible materials for wetted surfaces shall be used. To avoid air locking in smaller installations, small diameter suction lines shall be used with foot valves and degassing pump heads. In larger installations flooded suction shall be used with pipe work arranged to ease escape of gas bubbles. Calibration tubes or mass flow monitors which allow for direct physical checking of actual feed rates shall be provided. Injectors shall be made removable for regular cleaning where hard water is to be treated.
7.5.e. Ammonia. -- Ammonia for chloramines formation may be added to water either as a water solution of ammonium sulfate, or as aqua ammonia, or as anhydrous ammonia (purified 100% ammonia in liquid or gaseous form).
7.5.e.1. Ammonium sulfate. -- A water solution is made by the addition of ammonium sulfate solid to water with agitation. The tank and dosing equipment contact surfaces shall be made of corrosion resistant non-metallic materials. Provisions shall be made for removal of the agitator after dissolving the solid. The tank shall be fitted with an air-tight lid and vented outdoors. The application point shall be at the center of treated water flow at a location where there is high velocity movement.
7.5.e.2. Aqua ammonia (ammonium hydroxide). -- Aqua ammonia feed pumps and storage shall be enclosed and separated from other operating areas. The aqua ammonia room shall be equipped as per a chlorine gas room with the following changes: Corrosion resistant, closed, unpressurized tank shall be used for bulk liquid storage and day tanks, vented through inert liquid traps to a high point outside; an incompatible connector or lockout provisions shall be provided to prevent accidental addition of other chemicals to the bulk liquid storage tank(s); the bulk liquid storage tank(s) shall be designed to avoid conditions where temperature increases cause the ammonia vapor pressure over the aqua ammonia to exceed atmospheric pressure by refrigeration or other means of external cooling, or by dilution and mixing of the contents with water without opening the bulk liquid storage tank; an exhaust fan shall be installed to withdraw air from high points in the room and makeup air shall be allowed to enter at a low point; the aqua ammonia shall be conveyed directly from a day tank to the treated water stream injector without the use of a carrier water stream unless the carrier stream is softened; the application point shall be placed in a region of rapid, preferably turbulent, water flow; provisions shall be made for easy access for removal of calcium scale deposits from the injector; and provisions of a modestly-sized scrubber capable of handling occasional minor emissions should be considered.
7.5.e.3. Anhydrous ammonia. -- Anhydrous ammonia is readily available as a pure liquefied gas under moderate pressure in cylinders or as a cryogenic liquid boiling at -15 Celsius at atmospheric pressure. The liquid causes severe burns on skin contact. Anhydrous ammonia and storage feed systems (including heaters where required) shall be enclosed and separated from other work areas and constructed of corrosion resistant materials. Pressurized ammonia feed lines shall be restricted to the ammonia room. An emergency air exhaust system with an elevated intake shall be provided in the ammonia storage room. Leak detection systems shall be provided in all areas through which ammonia is piped. Special vacuum breaker/regulator provisions must be made to avoid potentially violent results of backflow of water into cylinders or storage tanks. Carrier water systems of soft or pre-softened water may be used to transport ammonia to the application point and to assist in mixing. The ammonia injector should use a vacuum eductor or consist of a perforated tube fitted with a closely fitting flexible rubber tubing seal punctured with a number of small slits to delay fouling by lime or other scale deposits. Provisions shall be made for periodic removal of lime or other scale deposits from injectors and carrier piping. Consideration shall be given to the provision of an emergency gas scrubber capable of absorbing the entire contents of the largest anhydrous ammonia storage unit whenever there is a risk to the public as a result of potential ammonia leaks.
7.5.f. Potassium permanganate. -- A source of heated water should be available for dissolving potassium permanganate and mechanical mixers shall be provided.
7.5.g. Fluoride – At least two (2) diaphragm operated anti-siphon devices shall be provided on all fluoride saturator or fluosilicic acid feed systems with one (1) diaphragm operated anti-siphon device to be located on the discharge side of the feed pump and one (1) to be located at the point of application. A physical break box is required in high hazard situations where the application point is substantially lower than the metering pump. In this situation, either a dual head feed pump or two (2) separate pumps are required and the anti-siphon device at the discharge side of the pump may be omitted. The point of application shall enter into the lower half of the pipe, preferably at a forty-five (45) degree angle from the bottom of the pipe and shall protrude into the pipe one third of the pipe diameter.
7.6. Other chemical feed system or treatment methodologies may be installed in accordance with manufacturers and industry recommendations if approved by the BPH.
W. Va. Code R. § 64-77-8 Pumping Facilities
8.1. General. -- Pumping facilities shall be designed to maintain the sanitary quality of pumped water. Subsurface pits or pump rooms and inaccessible installations shall be avoided. No pumping station shall be subject to flooding.
8.2. Location. -- The pumping station shall be located so that the proposed site meets the requirements for sanitary protection of water quality, hydraulics of the system and protection against interruption of service by fire, flood or any other hazard.
8.2.a. Site protection. -- The pumping station shall be: elevated to a minimum of three (3) feet above the one hundred (100) year flood elevation, or three (3) feet above the highest recorded flood elevation, whichever is higher, or protected to such elevations; readily accessible at all times unless permitted to be out of service for the period of inaccessibility; graded around the station so as to drain surface water away from the station; protected to prevent vandalism and entrance by animals or unauthorized persons. The pump station shall be located within a secure area such as a locked building or fenced area; and labeled such that the pumps and valves in the station are tagged to correspond to the maintenance record and for proper identification.
8.3. Pumping Stations.
8.3.a. Both raw and finished water pumping stations: shall have adequate space for the installation of additional units, if needed, and for the safe servicing of all equipment; be of durable construction, fire and weather resistant and with outward-opening doors; have a floor elevation of at least six (6) inches above finished grade; have underground structure waterproofed; have all floors drained in such a manner that the quality of the potable water is not endangered; have floors slope to a suitable drain; provide a suitable outlet for drainage from pump glands without discharging onto the floor; provide sampling taps, suction and discharge pressure gauges with stop cocks; and provide metering facilities.
8.3.b. Suction well. -- Suction wells shall be watertight, have floors sloped to permit removal of water and entrained solids, be covered or otherwise protected against contamination and have two pumping compartments or other means to allow the suction well to be taken out of service for inspection, maintenance or repair.
8.3.c. Equipment servicing. -- Pump stations shall be provided with: crane-ways, hoist beams, eye bolts, or other adequate facilities for servicing or removal of pumps, motors or other heavy equipment; openings in floors, roofs or wherever else needed for removal of heavy or bulky equipment; and a convenient tool board, or other facilities as needed, for proper maintenance of the equipment.
8.3.d. Stairways and ladders shall: be provided between all floors and in pits or compartments that are entered; and have handrails on both sides, and treads of non-slip material. Stairs are preferred in areas where there is frequent traffic or where supplies are transported by hand. They shall have risers not exceeding nine (9) inches and treads wide enough for safety.
8.3.e. Heating. -- Provisions shall be made for adequate heating for the comfort of the operator and the safe and efficient operation of the equipment. In pump houses not occupied by personnel, only enough heat need be provided to prevent freezing of equipment or treatment process.
8.3.f. Ventilation. -- Ventilation shall conform to existing local and state codes. Adequate ventilation shall be provided for all pumping stations. Forced ventilation of at least six (6) changes of air per hour shall be provided for all rooms, compartments, pits and other enclosures below the ground floor and any area where an unsafe atmosphere may develop or where excessive heat may be built up.
8.3.g. Dehumidification. -- In areas where excess moisture could cause hazards to safety or damage to equipment, means for dehumidification shall be provided.
8.3.h. Lighting. -- Pump stations shall be adequately lighted throughout. All electrical work shall conform to the requirements of the NEC and the relevant state and local codes.
8.3.i. Sanitary and other conveniences. -- All pumping stations that are manned for extended periods shall be provided with potable water, lavatory and toilet facilities. Plumbing shall be installed so as to prevent contamination of a public water supply.
8.4. Ground Water Pump Stations. -- Where pumping facilities are used, wells and springs shall be vented by properly hooded and screened pipe extending at least twelve (12) inches above the pump station floor or ground surface. Where necessary, provision shall be made for lubricating the pump from a point at least six (6) inches above the top of the well cover, by means that prevents contamination of the water supply.
8.4.a. Driven or Drilled Wells. -- Pumping stations located over driven or drilled wells shall: have riser pipe or casing extending at least six (6) inches, and preferably twelve (12) inches, above the floor, and equipped with a flange or suitable stuffing box; have riser pipe or casing firmly connected to the pump structure or have casing inserted into a recess extending at least one (1) inch into the base of the pump, if a watertight connection is not provided; have the base of the pump not less than six (6) inches above the pump room floor; and have the pump foundation and base designed to prevent water from coming into contact with the joint.
8.4.b. Submersible Pumps. -- Where a submersible pump is used, the top of the casing shall be equipped with pitless adaptors or vents, or both, approved by the NSF or WSC with an approved cap to effectively seal against entrance of water under all conditions of vibration or movements of conductors or cables.
8.4.c. Discharge Piping. -- Discharge piping shall be provided with means to pump to waste but shall not be directly connected to a sewer. The discharge line shall have control valves located above the pump floor, be protected against freezing, be valved to permit testing and control of each well, have watertight joints, and have all exposed valves protected.
8.5. Pumps.
8.5.a. At least two pumping units shall be provided. With any pump out of service, the remaining pump or pumps shall be capable of providing the maximum daily pumping demand of the system. The pumping units shall: have ample capacity to supply the peak demand against the required distribution system pressure without dangerous overloading; be driven by prime movers able to meet the maximum horsepower condition of the pumps; be provided with readily available spare parts and tools; be served by control equipment that has proper heater and overload protection for air temperature encountered; and be able to pump the maximum pumping demand of the system.
8.5.b. Suction lift. -- Suction lift shall be avoided, if possible, and be within manufacturers specifications, preferably less than fifteen (15) feet. If suction lift is necessary, provision shall be made for priming the pumps.
8.5.c. Priming. -- Priming water shall not be of lesser sanitary quality than that of the water being pumped. Means shall be provided to prevent backpressure or backsiphonage backflow. When an air-operated ejector is used, the screened intake shall draw clean air from a point at least ten (10) feet above the ground or other source of possible contamination unless the air is filtered by an apparatus approved by the BPH. Vacuum priming may be used.
8.6. Booster Pumps.
8.6.a. Booster pump stations shall be constructed in accordance with "Pumping Stations," in subsection 8.3 of this section, and shall contain sampling taps and sufficient room for booster chlorination facilities.
8.6.b. Booster pumps shall be located or controlled so that they do not produce negative pressure in their suction lines. Pumps installed in the distribution system shall maintain inlet pressure as required in Subdivision 10.2.b under all operating conditions. Pumps taking suction from storage tanks shall be provided adequate net positive suction head. Automatic shutoff or low pressure controller shall maintain at least 20 psi in the suction line under all operating conditions, unless otherwise approved by the BPH. Pumps taking suction from ground storage tanks shall be equipped with automatic shutoffs or low pressure controllers as required by the pump manufacturer. Automatic or remote control devices shall have a range between the start and cutoff pressure that prevents excessive cycling. A bypass shall be available.
8.6.c. Duplicate pumps. -- Each booster pumping station shall contain not less than two (2) pumps with capacities such that peak demand can be satisfied with the largest pump out of service.
8.6.d. Metering. -- All booster pumping stations shall be fitted with a flow rate indicating and totalizer meter.
8.6.e. In-line booster pumps. -- In-line booster pumps shall be accessible for servicing and repairs.
8.6.f. Individual home booster pumps. -- Individual home booster pumps shall not be allowed for any individual service from the public water supply main where residual pressures are less than five (5) pounds per square inch under any flow conditions. Where used, backflow prevention, approved by the BPH, consisting of at least a double check valve assembly shall be provided by the customer to protect the public water supply.
8.7. Automatic and Remote Controlled Stations. -- All automatic stations shall be provided with automatic signaling apparatus that reports when the station is out of service. All remote controlled stations shall be electrically operated and controlled and shall have signaling apparatus of proven performance. Installation of electrical equipment shall conform with the applicable state and local electrical codes and the National Electrical Code.
8.8. Appurtenances.
8.8.a. Valves. -- Each pump shall have an isolation valve on the intake and discharge side of the pump to permit satisfactory operation, maintenance and repair of the equipment. If foot valves are necessary, they shall have a net valve area of at least two and a half (2½) times the area of the suction pipe, and they shall be screened. Each pump shall have a positive-acting check valve on the discharge side between the pump and the shut-off valve. Surge relief valves or slow acting check valves shall be designed to minimize hydraulic transients.
8.8.b. Piping. -- In general, piping shall: be designed so that the friction losses are minimized and not be subject to contamination; have watertight joints; be protected against a surge or water hammer; be such that each pump has an individual suction line or lines are so manifolded that they insure similar hydraulic and operating conditions,
8.8.c. Gauges and meters. -- Each pump shall have a pressure gauge on its discharge line, shall have a compound gauge on its suction line, shall have recording meters and gauges in the larger stations (250 gallons per minute or larger) and shall have a means for measuring the discharge. The station shall have indicating, totalizing and recording metering of the total water pumped.
8.8.d. Water seals. -- Water seals shall not be supplied with water of a lesser sanitary quality than that of the water being pumped. Where pumps are sealed with potable water and are pumping water of less sanitary quality the seal shall be provided with either an approved reduced pressure backflow assembly or a break tank open to atmospheric pressure and have an air gap of at least six (6) inches or two (2) pipe diameters, whichever is greater, between the feeder line and the spill line of the tank.
8.8.e. Controls. -- Pumps, their motors and accessories, shall be controlled in such a manner that they operate at rated capacity without dangerous overload. Where two (2) or more pumps are installed for redundancy, provision shall be made for alternation. Provision shall be made to prevent energizing the motor in the event of a backspin cycle. Electrical controls shall be installed in accordance with NEC requirements. Equipment shall be provided, or other arrangements shall be made, to prevent surge pressures from activating controls that switch on pumps or activate other equipment outside the normal design cycle of operation.
8.8.f. Standby power. -- To ensure continuous service when the primary power had been interrupted, a power supply shall be provided from at least two (2) independent sources or a standby or an auxiliary source shall be provided. If standby power is provided by on-site generators or engines, the fuel storage and fuel line shall be designed to protect the water supply from contamination.
8.8.g. Water pre-lubrication. -- When automatic pre-lubrication of pump bearings is necessary and an auxiliary direct drive power supply is provided, the pre-lubrication line shall be provided with a valved bypass around the automatic control so that the bearings can, if necessary, be lubricated manually before the pump is started or the pre-lubrication controls shall be wired to the auxiliary power supply.
8.8.h. Oil or grease lubrication. -- All lubricants which come into contact with the potable water shall be certified for conformance to ANSI/NSF Standard 60.
W. Va. Code R. § 64-77-9 Finished Water Storage
9.1. General. -- The materials and designs used for finished water storage structures shall provide stability and durability as well as protect the quality of the stored water. Steel structures shall follow the current AWWA standards concerning steel tanks, standpipes, reservoirs, and elevated tanks wherever they are applicable. Other materials of construction are acceptable when properly designed to meet the requirements of this section.
9.1.a. Sizing. -- Storage facilities shall have sufficient capacity, as determined from engineering studies, to meet domestic, commercial and industrial demands, and where fire protection is provided, fire flow demands.
9.1.a.1. Fire flow requirements established by the ISO shall be satisfied where fire protection is provided.
9.1.a.2. The minimum storage capacity (or equivalent capacity) for systems providing fire protection shall be equal to twice the average daily demand of one hundred fifty (150) gallons per customer per day plus fire flow unless it can be demonstrated that the supply capacity of the system is sufficient to warrant less. This requirement may be reduced when the source and treatment facilities have sufficient capacity with standby power to supplement peak demands of the system.
9.1.a.3. A recommended storage capacity for community and non-community, non-transient public water systems not providing fire protection shall be equal to twice the average daily demand of one hundred fifty (150) gallons per customer per day.
9.1.b. Location of ground-level reservoirs. -- The bottom of reservoirs and standpipes shall be placed at the normal ground surface and shall be above the one hundred (100) year flood level. When the bottom is below normal ground surface, it shall be placed above the groundwater table. At least fifty per cent (50%) of the water depth of the reservoir may be above grade. Sewers, drains, standing water, and similar sources of possible contamination shall be kept at least fifty (50) feet from the reservoir. A water main pipe, pressure tested in place to fifty (50) pounds per square inch without leakage, may be located from twenty (20) to fifty (50) feet from a sewer, but under no circumstances shall it be located within twenty (20) feet of a sewer.
The top of a partially buried storage structure shall be at least two (2) feet above normal ground surface. Clearwells constructed under filters may be excepted from this requirement when the design provides adequate protection from contamination.
9.1.c. Protection. -- All finished water storage structures shall have suitable watertight roofs and screened vents that exclude birds, animals, insects, and excessive dust. The installation of appurtenances, such as antenna, shall be done in a manner that ensures no damage to the tank, coatings or water quality.
9.1.d. Protection from trespassers. -- Fencing, locks on access manholes, and other necessary precautions shall be provided to prevent trespassing, vandalism and sabotage, including the installation of high strength locks or lock covers to prevent direct cutting of a lock, if possible.
9.1.e. Drains. -- No drain on a water storage structure may have a direct connection to a sewer or storm drain. The design shall allow draining the storage facility for cleaning or maintenance without causing loss of pressure in the distribution system.
9.1.f. Overflow. -- All water storage structures shall be provided with an overflow that is brought down to an elevation between twelve (12) and twenty-four (24) inches above the ground surface and that discharges over a drainage inlet structure or a splash plate. No overflow may be connected directly to a sewer or a storm drain. All overflow pipes shall be located so that any discharge is visible.
9.1.f.1. When an internal overflow pipe is used on elevated tanks, it shall be located in the access tube. For vertical drops on other types of storage facilities, the overflow pipe shall be located on the outside of the structure.
9.1.f.2. The overflow of a ground-level structure shall open downward and be screened with twenty-four (24) mesh non-corrodible screen installed within the pipe at a location least susceptible to damage by vandalism.
9.1.f.3. The overflow pipe shall be of sufficient diameter to permit waste of water in excess of the filling rate.
9.1.g. Access. -- Finished water storage structures shall be designed with reasonably convenient access to the interior for cleaning and maintenance. Manholes above the water line: shall be framed at least four (4) inches, and preferably (6) six inches, above the surface of the roof at the opening; on ground-level structures, shall be elevated twenty-four (24) to thirty-six (36) inches above the top or covering sod; shall be fitted with a solid watertight cover that overlaps the framed opening and extends down around the frame at least two (2) inches; shall be hinged at one (1) side; and shall have a locking device.
9.1.h. Vents. -- Finished water storage structures shall be vented. Overflows shall not be considered as vents. Open construction between the sidewall and roof is not permissible. Vents shall prevent the entrance of surface water and rainwater and shall exclude birds, animals and insects, as much as this function can be made compatible with effective venting. For elevated tanks and standpipes, four (4) mesh non-corrodible screen may be used. On ground-level structures, standpipes shall terminate in an inverted U construction with the opening twenty-four (24) to thirty-six (36) inches above the roof or sod and be covered with twenty-four (24) mesh non-corrodible screen installed within the pipe at a location least susceptible to vandalism.
9.1.i. Roof and sidewall. -- The roof and sidewalls of all structures shall be watertight with no openings except properly constructed vents, manholes, overflows, risers, drains, pump mountings, control ports and piping for inflow and outflow.
9.1.i.1. Any pipes running through the roof or sidewall of a finished water storage structure shall be welded, or properly gasketed in metal tanks. In concrete tanks, these pipes shall be connected to standard wall castings that were poured in place during the forming of the concrete. These wall castings shall have seepage rings imbedded in the concrete.
9.1.i.2. Openings in a storage structure roof or top, designed to accommodate control apparatus or pump columns, shall be curbed and sleeved with proper additional shielding to prevent the access of surface or floor drainage water into the structure.
9.1.i.3. Valves and controls shall be located outside the storage structure so that the valve stems and similar projections do not pass through the roof or top of the reservoir.
9.1.i.4. The roof of concrete reservoirs with an earthen cover shall be sloped to facilitate drainage. Consideration shall be given to installation of an impermeable membrane roof covering.
9.1.i.5. Locks shall be provided on valve vaults where applicable.
9.1.j. Drainage of roof. -- The roof of the storage structure shall be well drained. Downspout pipes shall not enter or pass through the reservoir. Parapets, or similar construction that would tend to hold water and snow on the roof, shall not be approved by the BPH unless adequate waterproofing and drainage are provided.
9.1.k. Safety. -- The safety of employees shall be considered in the design of the storage structure. As a minimum, employee safety matters shall conform to pertinent laws and rules.
9.1.k.1. Ladders, ladder guards, balcony railings, and safely located entrance hatches shall be provided where applicable. Elevated tanks with riser pipes more than eight inches in diameter shall have protective bars over the riser openings inside the tank. Railings or handholds shall be provided on elevated tanks where persons transfer from the access tube to the water compartment. Confined space entry requirements shall be considered.
9.1.l. Freezing. -- All finished water storage structures and their appurtenances, especially the riser pipes, overflows, and vents, shall be designed to prevent freezing that interferes with proper functioning. Equipment used for freeze protection that comes into contact with the potable water shall meet ANSI/NSF Standard 61 or be approved by the BPH. If a water circulation system is used, it is recommended that the circulation pipe be located separately from the riser pipe.
9.1.m. Internal catwalk. -- Every catwalk over finished water in a storage structure shall have a solid floor with raised edges designed so that shoe scrapings and dirt do not fall into the water.
9.1.n. Silt stop. -- The discharge pipes from all reservoirs shall be located in a manner that prevents the flow of sediment into the distribution system. Removable silt stops shall be provided.
9.1.o. Grading. -- The area surrounding a ground-level structure shall be graded in a manner that prevents surface water from standing within fifty (50) feet.
9.1.p. Painting and cathodic protection. -- Proper protection shall be given to metal surfaces by paints or other protective coatings, by cathodic protective devices, or by both. Paint systems shall be certified to conform to ANSI/NSF Standard 61: Drinking Water System Components - Health Effects. Interior paint shall be properly applied and cured. After curing, the coating shall not transfer any substance to the water that is toxic or cause tastes or odors. Prior to placing in service, an analysis for volatile organic compounds is advisable to establish that the coating is properly cured. Consideration shall be given to 100% solids coatings. Wax coatings for the tank interior shall not be used on new tanks. Recoating with a wax system is not allowed. Old wax coating shall be completely removed before using another coating. Cathodic protection shall be installed on below grade steel reservoirs and shall be designed and installed by competent technical personnel; a maintenance contract shall be provided.
9.1.q. Disinfection. -- Finished water storage structures shall be disinfected in accordance with current AWWA Standard C652. Two (2) or more successive sets of samples, taken at twenty-four (24) hour intervals, shall be microbiologically satisfactory before the facility is placed into operation. Disposal of heavily chlorinated water from the tank disinfection process shall be in accordance with the requirements of the WVDEP. The disinfection procedure (AWWA C652 chlorination method 3, subsection 4.3.) that allows use of the chlorinated water held in the storage tank for disinfection purposes is not recommended. When that procedure is used, it is recommended that the initial heavily chlorinated water be properly disposed in order to prevent the release of water that may contain various chlorinated organic compounds into the distribution system.
9.1.r. Provisions of Sampling. -- Smooth-nosed sampling taps shall be provided to facilitate collection of water samples for both bacteriologic and chemical analysis. The sampling tap(s) shall be easily accessible.
9.2. Plant Storage. -- The applicable design standards for finished water storage shall be followed for plant storage.
9.2.a. Filter Washwater tanks. -- Filter washwater tanks shall be sized, in conjunction with available pump units and finished water storage, to provide the backwash water required. Consideration shall be given to the backwashing of several filters in rapid succession.
9.2.b. Clearwell. -- Clearwell storage shall be sized, in conjunction with distribution system storage, to relieve the filters from having to follow fluctuations in water use and meet peak demands, including filter backwash water. When finished water storage is used to provide contact time for chlorine, special attention shall be given to size and baffling. To ensure adequate chlorine contact time in accordance with the West Virginia Bureau for Public Health rule, Public Water Systems, 64CSR3, sizing of the clearwell shall include extra volume to accommodate depletion of storage during the nighttime for intermittently operated filtration plants with automatic high service pumping from the clearwell during non-treatment hours. An overflow and vent shall be provided. A minimum of two (2) clearwell compartments shall be provided.
9.2.c. Adjacent compartments. -- Finished water shall not be stored or conveyed in a compartment adjacent to untreated or partially treated water when the two compartments are separated by a single wall.
9.2.d. Other treatment plant storage tanks. -- Receiving basins, detention basins, backwash reclaim tanks and pump wet wells for finished water shall be designed as finished water storage structures.
9.3. Hydropneumatic Tanks. -- Hydropneumatic (pressure) tanks serving community and non-community, non-transient public water systems, when provided as the only storage facility, are acceptable only in very small service areas. Systems serving more than 150 living units shall have ground or elevated storage. Hydropneumatic tank storage is not permitted for fire protection purposes. Pressure tanks shall meet ASME code requirements or an equivalent requirement of state or local laws and rules of construction and installation of unfired pressure vessels. Non-ASME, factory-built hydropneumatic tanks may be allowed if approved by the BPH.
9.3.a. Location. -- The tank shall be located above normal ground surface and be completely housed.
9.3.b. Sizing. -- The capacity of the pumps in a hydropneumatic system shall be at least ten (10) times the average daily consumption rate. The gross volume of the hydropneumatic tank, in gallons, shall be at least ten (10) times the capacity of the largest pump, rated in gallons per minute. For example, a two hundred fifty (250) gallon per minute pump shall have a two thousand five hundred (2,500) gallon pressure tank, unless other measures, such as variable speed drives in conjunction with the pump motors are provided to meet the maximum demand. Sizing of hydropneumatic storage tanks shall consider the need for chlorine detention time, as applicable, independent of the storage requirements. If hydropneumatic tanks are considered for chlorine contact, separate inlet and outlet connectors at top and bottom of the tank are required.
9.3.c. Piping. -- The hydropneumatic tank shall have bypass piping to permit operation of the system while it is being repaired or painted.
9.3.d. Appurtenances. -- Each hydropneumatic tank shall have an access manhole, a drain and control equipment consisting of pressure gauge, water sight glass, automatic or manual air blow-off, a means for adding air, and pressure operated start-stop controls for the pumps. A pressure relief valve shall be installed and be capable of handling the full pumpage rate of flow at the pressure vessel design limit. Where practical the access manhole shall be twenty-four (24) inches in diameter.
9.3.e. Coatings. -- The interior coating of all tanks shall meet ANSI/NSF Standard 61: Drinking Water System Components - Health Effects.
9.4. Distribution Storage. -- The applicable design standards of subsection 9.1. of this rule shall be followed for distribution system storage. The minimum storage capacity (or equivalent capacity) for systems providing fire protection shall be equal to twice the average daily demand of one hundred fifty (150) gallons per customer per day plus fire flow unless it can be demonstrated that the supply capacity of the system is sufficient to warrant less. All tanks shall be controlled to provide an adequate turn-over of at least twenty percent (20%) of the total volume each twenty-four (24) hour period. The BPH may allow a variance to the minimum twenty percent (20%) turn-over requirement, if adequate justification is provided such as no distribution water quality violations, booster chlorination, etc. This may require a main line altitude valve or externally controlled valves.
9.4.a. Pressures. -- The maximum variation between high and low levels in standpipes or elevated storage structures providing pressure to a distribution system shall not exceed thirty (30) feet (thirteen (13) pounds per square inch). The minimum pressure in the distribution system shall be thirty (30) pounds per square inch under static conditions and twenty (20) pounds per square inch under all flow conditions. The normal working pressures of the distribution mains shall be designed based upon the pipe manufacturer’s recommendations and the applicable AWWA standards for the type of pipe. Pressure regulating/pressure reducing valves shall be used to protect the distribution mains from excessive pressures. When static pressures in the distribution mains exceed one hundred thirty five (135) pounds per square inch, the utility shall have the option of installing pressure reducing valves on service lines or requiring (or recommending) the customer install and maintain a pressure reducing valve on the customer’s service line.
9.4.b. Drainage. -- Storage structures that provide pressure directly to the distribution system shall be designed so they can be isolated from the distribution system and drained for cleaning or maintenance without necessitating loss of pressure in the distribution system. The drain shall discharge to the ground surface with no direct connection to a sewer or storm drain.
9.4.c. Level controls. -- Commercially available control systems shall be provided to maintain levels in distribution system storage structures for community and non-community, non-transient public water systems. Level indicating devices shall be provided at a central location. Pumps shall be controlled from tank levels with the signal transmitted by telemetering equipment when any appreciable head loss occurs in the distribution system between the source and the storage structure. Altitude valves or equivalent controls may be required for additional structures on the system. Overflow and low-level warnings or alarms shall be located at places in the community where they are under responsible surveillance twenty-four (24) hours a day.
W. Va. Code R. § 64-77-10 Distribution Systems
10.1. Materials.
10.1.a. Standards and materials selection. -- Pipe, fittings, valves and fire hydrants shall conform to ASTM, AWWA standards, meet ANSI/NSF Standard 61: Drinking Water System Components - Health Effects and shall be acceptable to the BPH. In the absence of these standards, materials meeting applicable product standards and acceptable to the BPH may be selected. Special attention shall be given to selecting pipe materials that protect against both internal and external pipe corrosion. Pipes and pipe fittings containing more than eight percent (8%) lead shall not be used. All products shall comply with ANSI/NSF Standard 61: Drinking Water System Components - Health Effects.
10.1.b. Permeation of system by organic compounds. -- Where distribution systems are installed in areas of groundwater contaminated by organic compounds: pipe and joint materials that are not subject to permeation of the organic compounds shall be used; and non-permeable materials shall be used for all portions of the system including water main, service connections and hydrant leads.
10.1.c. Used materials. -- Water mains that have been used previously for conveying potable water may be reused provided they meet the standards contained in this rule.
10.1.d. Joints. -- Packing and jointing materials used in the joints of pipe shall meet the standards of the AWWA, ANSI/NSF Standard 61 and the BPH. Pipe having mechanical joints or slip-on joints with rubber gaskets is preferred. Lead-tip gaskets shall not be used. Repairs to lead-joint pipe shall be made using alternative methods. Manufacturer approved transition joints shall be used between dissimilar piping materials.
10.2. Water Main Design.
10.2.a. All distribution systems shall be designed to provide a residential peak demand flow (not including fire flows) in accordance with Table 64-77E of this rule.
10.2.b. Pressure. -- All water mains, including those not designed to provide fire protection, shall be sized after a hydraulic analysis based on peak flow demands and pressure requirements. The system shall be designed to maintain a minimum pressure of twenty (20) pounds per square inch at ground level at all points in the distribution system under all conditions of flow and thirty (30) pounds per square inch under static conditions. The normal working pressure in the distribution system shall be designed based upon the pipe manufacturer’s recommendations and the applicable AWWA standards for the type of pipe.
10.2.c. Surge Pressures. -- All water mains shall be designed to provide adequate strength to withstand water surge pressure. Table 64-77F of this rule lists the minimum acceptable pressure surge for PVC for each foot per second velocity of water. Design shall allow for at least five (5) feet per second instantaneous flow velocity change or higher if conditions warrant.
10.2.d. Diameter. -- The minimum size of a water main for providing fire protection and serving fire hydrants shall be of six (6) inch diameter. Larger size mains are required if necessary to allow the withdrawal of the required fire flow while maintaining the minimum residual pressures.
10.2.e. Fire protection. -- When fire protection is to be provided, the recommended system design shall be such that fire flows and facilities are in accordance with the requirements of the ISO. Under no circumstances shall fire flows be less than two hundred fifty (250) gallons per minute.
10.2.f. Small mains. -- Any departure from minimum six (6) inch diameter requirements shall be justified by hydraulic analysis and future water use, and can be considered only in special circumstances; however, no mains less than two (2) inches are permitted.
10.2.g. Hydrants. -- Water mains not designed to carry fire-flows shall not have fire hydrants connected to them.
10.2.h. Dead ends. -- In order to provide increased reliability of service and reduce head loss, dead ends shall be minimized by making appropriate tie-ins whenever practical. Where dead-end mains occur, they shall be provided with a fire hydrant if flow and pressure are sufficient, or with a flushing hydrant or blow-off, approved by the BPH, for flushing purposes. Flushing devices shall be sized to provide flows that give a velocity of at least two and a half (2.5) feet per second in the water main being flushed. No flushing devices shall be directly connected to any sewer.
10.3. Valves. -- A sufficient number of valves shall be provided on water mains so that inconvenience and sanitary hazards are minimized during repairs. Valves shall be located at not more than five hundred (500) foot intervals in commercial districts and at not more than one block or eight hundred (800) foot intervals in other districts. Where systems serve widely scattered customers and where future development is not expected, the valve spacing shall not exceed two thousand five hundred (2,500) feet.
10.4. Hydrants.
10.4.a. Location and spacing. -- Hydrants shall be provided at each street intersection and at intermediate points between intersections as recommended by the ISO. Generally, hydrant spacing may range from three hundred fifty (350) to one thousand (1000) feet depending on the area being served.
10.4.b. Valves and nozzles. -- Fire hydrants shall have a bottom valve size of at least five (5”) inches, one four and one half (4½”) inch pumper nozzle and two (2) two and a half (2½”) inch nozzles.
10.4.c. Hydrant leads. -- The hydrant lead shall be a minimum of six (6) inches in diameter. Auxiliary valves shall be installed in all hydrant leads.
10.4.d. Drainage. -- Hydrant drains shall be provided with a gravel pocket, or a dry well shall be provided unless the natural soils provide adequate drainage. Hydrant drains shall not be connected to or located within ten (10) feet of sanitary sewers or storm drains.
10.4.e. Draining type frost proof yard hydrants are not permitted.
10.5. Air Relief Valves, Valve, Meter and Blow-off Chambers.
10.5.a. Air relief valves. -- At high points in water mains where air can accumulate, provisions shall be made to remove the air by means of hydrants or air relief valves. Automatic air relief valves shall not be used in situations where flooding of the manhole or chamber may occur.
10.5.b. Air relief valve piping. -- The open end of an air relief pipe from automatic valves shall be provided with a screened, downward-facing elbow. The pipe from a manually operated valve shall be extended to the top of the pit. Use of manual air relief valves is recommended wherever possible.
10.5.c. Chamber drainage. -- Chambers, pits or manholes containing valves, blow-offs, meters or other such appurtenances to a distribution system shall not be connected directly to any storm drain or sanitary sewer nor shall blow-offs or air relief valves be connected directly to any sewer. These chambers or pits shall be drained to the surface of the ground where they are not subject to flooding by surface water or to absorption pits underground.
10.6. Installation of Mains.
10.6.a. Standards. -- Specifications shall incorporate the provisions of the AWWA standards and manufacturer's recommended installation procedures.
10.6.b. Bedding. -- A continuous and uniform bedding shall be provided in the trench for all buried pipe. Backfill material shall be tamped in layers around the pipe and to a sufficient height above the pipe to adequately support and protect the pipe. Stones found in the trench shall be removed for a depth of at least six (6) inches below the bottom of the pipe.
10.6.c. Cover. -- All water mains shall be covered with sufficient earth or other insulation to prevent freezing. All distribution mains shall be provided with a minimum of thirty-six (36) inches of earth covering; forty-two (42) inches are recommended. All mains of less than eight (8) inches in diameter within five (5) feet of a heavily traveled highway shall be provided with at least forty-two (42) inches of cover.
10.6.d. Blocking. -- All tees, bends, plugs and hydrants shall be provided with reaction blocking, tie rods or joints designed to prevent movement.
10.6.e. Pressure and leakage testing. -- All types of installed pipe shall be pressure tested and leakage tested in accordance with AWWA Standard C600.
10.6.f. Disinfection. -- All new, cleaned or repaired water mains shall be disinfected in accordance with AWWA Standard C651. The specifications shall include microbiological testing of all water mains. Microbiological sampling shall be collected by a BPH certified public water system operator or other individual authorized by the BPH.
10.6.g. All non-metallic mains shall be provided with tracer wire or metallic tape.
10.6.h. Anchoring of fusible pipe. -- Additional restraint may be necessary on fusible pipe at the connection to appurtenances or transitions to different pipe materials to prevent separation of joints. The restraint may be provided in the form of an anchor ring encased in concrete or other methods as approved by the BPH.
10.6.i. External corrosion. -- If soils are found to be aggressive, necessary action to protect the water main shall be taken, such as by encasement of the water main in polyethylene, provision of cathodic protection (in very severe instances), or using corrosion resistant water main materials.
10.7. Separation of Water Mains, Sanitary Sewers and Storm Sewers.
10.7.a. General. -- The following factors shall be considered in providing adequate separation: materials and type of joints for water and sewer pipes; soil conditions; service and branch connections into the water main and sewer line compensating variations in the horizontal and vertical separations; space for repair and alterations of water and sewer pipes and off-setting of pipes around manholes.
10.7.b. Parallel installation. -- Water mains shall be laid at least ten (10) feet horizontally from any existing or proposed sewer. The distance shall be measured edge to edge.
10.7.c. Crossings. -- Water mains shall cross above sewers and shall be laid to provide a minimum vertical distance of eighteen (18) inches between the bottom of the water main and the top of the sewer. At crossings, one full length (20 feet) of water pipe shall be located so both joints will be as far from the sewer as possible. Special structural support for the water and sewer pipes may be required.
10.7.d. Force mains. -- There shall be at least a ten (10) foot horizontal separation between water mains and sanitary sewer force mains. There shall be an eighteen (18) inch vertical separation at crossings as required.
10.7.e. Exception. -- The BPH may approve a variance from the above requirements when it determines that compliance with the specified separation distances cannot be practically achieved.
10.7.f. Sewer manholes. -- No water pipe shall pass through or come in contact with any part of a sewer manhole.
10.7.g. Separation of water mains from other sources of contamination. -- Design engineers shall exercise caution when locating water mains at or near certain sites such as sewage treatment plants or industrial complexes. Individual septic tanks shall be located and avoided. The engineer shall contact the BPH to establish specific design requirements for locating water mains near any source of contamination.
10.8. Surface Water Crossings. -- The BPH shall be consulted before final plans are prepared.
10.8.a. Above-water crossings. -- An above-water crossing pipe shall be adequately supported and anchored, be protected from vandalism, damage and freezing and be accessible for repair or replacement.
10.8.b. Underwater crossings. -- A minimum cover of three (3) feet shall be provided over the pipe unless otherwise approved by the BPH. When crossing water courses that are greater than fifteen (15) feet in width, the following shall be provided: the pipe shall be of special construction, having flexible watertight joints; valves shall be provided at both ends of water crossings so that the section can be isolated for testing or repair; the valves shall be easily accessible, and not subject to flooding; and permanent taps shall be made on each side of the valve to allow insertion of a small meter to determine leakage and for sampling purposes.
10.9. Cross-connections and Interconnections.
10.9.a. Cross-connections. -- There shall be no connection between the distribution system and any pipes, pumps, hydrants, or tanks whereby unsafe water or other contaminating materials may be discharged or drawn into the system. Each water utility shall have a program conforming to the BPH requirements to detect and eliminate cross connections.
10.9.b. Cooling water. -- Neither steam condensate nor cooling water from engine jackets or other heat exchange devices shall be returned to the potable water supply.
10.9.c. Interconnections. -- The approval of the BPH shall be obtained for interconnections between approved public water systems.
10.10. Water Services and Plumbing.
10.10.a. Plumbing. -- Water services and plumbing shall conform to relevant local and state plumbing codes or to the applicable National Plumbing Code. Solders and flux containing more than two tenths percent (0.2%) lead and pipe and pipe fittings containing more than eight percent (8%) lead shall not be used. The public water system is not responsible for an individual customer’s private plumbing.
10.10.b. Booster pumps. -- Individual booster pumps are not allowed for any individual service from the public water supply mains where residual pressures are less than five (5) pounds per square inch under all flow conditions. Where used, backflow prevention, approved by the BPH, consisting of at least a double check valve assembly shall be provided by the customer to protect the public water supply.
10.11. Service Meters. -- Each service connection shall be individually metered.
10.12. Water Loading Stations. -- Water loading stations present special problems since the fill line may be used for filling both potable water vessels and other tanks or contaminated vessels. To prevent contamination of both the public supply and potable water vessels being filled, the following principles shall be met in the design of water loading stations: there shall be a double check valve assembly approved by the BPH and installed to prevent backflow to the public water supply; the piping arrangement shall prevent contaminant being transferred from a hauling vessel to another. Hoses shall not be contaminated by contact with the ground and shall be capped when not in use. Water meters shall be provided.
W. Va. Code R. § 64-77-11 Enforcement Penalties
Violators of this rule are subject to the civil and administrative penalties of W. Va. Code §§16-1-9a(d)(2) and (3) and the criminal penalties of W. Va. Code §§16-1-9, 16-1-9a(d)(1) and 16-1-18.
W. Va. Code R. § 64-77-12 Administrative Due Process
Those persons aggrieved by the administrative enforcement of this rule may request a contested case hearing in accordance with the Bureau for Public Health procedural rule, "Rules and Procedures for Contested Case Hearings and Declaratory Rulings," 64CSR1.
TABLE 64-77A
Water Treatment Plant Pipe Color Code Requirements Water Lines Raw Olive Green Settled or Clarified Aqua Finished or Potable Dark Blue Chemical Lines Alum or Primary Coagulant Orange Ammonia White Carbon Slurry Black Caustic Yellow with Green Band Chlorine (Gas or Solution) Yellow Fluoride Light Blue with Red Band Lime Slurry Light Green Ozone Yellow with Orange Band Phosphate Compounds Light Green with Red Band Polymers or Coagulant Aids Orange with Green Band Potassium Permanganate Violet Soda Ash Light Green with Orange Band Sulfuric Acid Yellow with Red Band Sulfur Dioxide Light Green with Yellow Band Waste Lines Backwash Waste Light Brown Sludge Dark Brown Sewer (Sanitary or Other) Dark Gray Other Compressed Air Dark Green Gas Red Other Lines Light Gray TABLE 64-77B Minimum Horizontal Distance Between a New Public Water System Groundwater Well and a Potential Contamination Source Source Minimum Distance Septic Tanks 50 feet (100 feet)
Sewage Treatment Facilities 200 feet Sewers and Drains (Watertight) 10 feet Sewers and Drains (Non watertight) 50 feet (100 feet)
Sewage Holding Tanks and Privies (Vault) 50 feet (100 feet)
Barnyard/Feeding and Watering Areas 100 feet Streams, Rivers and Impoundments 25 feet Sewage Absorption Fields 100 feet Note that the distance noted in parenthesis shall be required when a water well is lower in elevation than the source of pollution or contamination referenced.
Note that the sewer and drain materials shall be of potable water main standards and installed and hydrostatically tested as approved by the commissioner.
TABLE 64-77 C
Rapid Rate Gravity Filters Size and Depth of Gravel Supporting Media Size Depth 2 1/2 to 1/2 inches 5 to 8 inches 1 1/2 to 3/4 inches 3 to 5 inches 3/4 to 1/2 inches 3 to 5 inches 1/2 to 3/16 inches 2 to 3 inches 3/16 to 3/32 inches 2 to 3 inches TABLE 64-77D Groundwater Well Steel Pipe Casing Requirements * SIZE DIAMETER (inches)
THICKNESS
(inches)
WEIGHT PER FOOT
(pounds)
EXTERNAL
INTERNAL
PLAIN ENDS
(calculated)
WITH THREADS
AND COUPLINGS
(nominal)
6 ID.
6.625
6.065
0.280
18.97
19.18
8.625
7.981
0.322
28.55
29.35
10.750
10.020
0.365
40.48
41.85
12.750
12.000
49.56
51.15 14 OD.
14.000
13.250
54.57
57.00
16.000
15.250
62.58
18.000
17.250
70.59
20.000
19.250
78.60
22.000
21.000
114.81
24.000
23.000
125.49
26.000
25.000
136.17
28.000
27.000
146.85
30.000
29.000
157.53
32.000
31.000
168.21
34.000
33.000
178.89
36.000
35.000
189.57 *Abstracted from AWWA Standard for Deep Wells, AWWA A100.
TABLE 64-77E
Estimated Peak Design Flows Per Home For Water Distribution Systems No. of Homes Peak Design Flow gpm No. of Homes Peak Design Flow gpm More than 400 homes, use 0.5 gallons per minute per home.
Note: Commercial, industrial, or other high-user customers are not covered in this table and shall be included in the design of the distribution system.
TABLE 64-77F
DESIGN TABLE FOR PVC PIPE
PRESSURE SURGE vs. DIMENSION RATIO [In response to 1 foot per second instantaneous flow velocity change]
Dimension Ratio Pressure Surge, psi (kPa)
13.5
20.2 (139)
19.8 (139)
17.9 (123)
17.4 (120)
16.0 (110)
14.7 (101)
14.4 (99)
32.5
12.8 (88)
11.4 (79)
Series 78 Radon Licensure
W. Va. Code R. § 64-78-1 General
1.1. Scope. -- This legislative rule establishes procedures and standards for the licensure and training of persons engaged in activities related to radon measurement or mitigation. This rule should be read in conjunction with the definitions and provisions of W. Va. Code '16-34-1 et seq. (Licensure of Radon Mitigators, Testers, Contractors and Laboratories).
1.2. Authority. -- W. Va. Code ''16-34-6 and 16-1-7.
1.3. Filing Date. -- April 29, 1999.
1.4. Effective Date. -- July 1, 1999.
W. Va. Code R. § 64-78-2 Application and Enforcement
2.1. Application - This rule applies to radon mitigators, radon testers, radon contractors, radon training facilities and radon laboratories.
2.2. Enforcement - The enforcement of this legislative rule is vested with the director of the Division of Health.
W. Va. Code R. § 64-78-3 Definitions
3.1. EPA - The United States Environmental Protection Agency.
W. Va. Code R. § 64-78-4 General Prohibitions
4.1. In addition to the prohibitions in W. Va. Code '16-34-3(a), no training shall be conducted without a valid radon training license.
4.2. Subsection 4.1 of this section does not apply to the individuals or entities described in W. Va. Code '16-34-3(b) or any of the following:
4.2.a. The regulation of construction practices; and
4.2.b. The regulation of retail sales of radon test kits for the use by individuals to conduct their own radon testing in buildings owned or leased by them.
W. Va. Code R. § 64-78-5 Application for Licensure as a Radon Mitigation Contractor, Radon Tester, Mitigation Specialist, Radon Laboratory, Radon Testing or Radon Training Facility
5.1. To apply for a license as a radon mitigation contractor, the applicant shall submit to the director an application provided by the director which shall include the following:
5.1.a. The name and business address of the applicant;
5.1.b. The name of the chief executive officer, partners or the sole proprietor of the business;
5.1.c. The names of employees directly involved in radon testing or mitigation and the following:
5.1.c.1. Documentation that each applicant or employee has successfully completed the training approved by the director. The documentation shall include the course title, course sponsor, names of course instructors, date and place of course; and
5.1.c.2. Documentation that the applicant has passed the examination recommended by the United States Environmental Protection Agency;
5.1.d. A description of any of the following matters to which the applicant or a person involved with the applicant on a radon project was a party:
5.1.d.1. Any radon mitigation or radon testing projects which were terminated prior to completion;
5.1.d.2. Any penalties, citations, administrative orders or actions pertaining to radon mitigation or radon testing; or
5.1.d.3. Any lawsuits pertaining to radon mitigation or radon testing. Copies of initial pleadings and final orders shall be attached to the application;
5.1.e. A description of the basic quality assurance and quality control procedures that will be utilized by the applicant for each type of measurement device used;
5.1.f. A description of the radiological safety plan designed to track employee radon exposure and keep it as low as reasonably achievable;
5.1.g. A description by type, manufacture and model number of all instruments to be used in radon measurements. If the applicant intends to use devices requiring non-portable equipment for analysis, the applicant shall list the name and address of the radon laboratory providing the analysis and its issued license number; and
5.1.h. A description of the method of instrument calibrations.
5.2. To apply for a license as a radon tester, the applicant shall:
5.2.a. Submit to the director an application on a form prescribed and provided by the director, which shall include the information required by paragraphs 5.1.a. and 5.1.e. to 5.1.h. of this section.
5.2.b. Provide documentation that the applicant has successfully completed the training required by paragraph 5.1.c.1. of this section; and
5.2.c. Provide documentation that the applicant has passed the examination required by paragraph 5.1.c.2. of this section.
5.3. To apply for a license as a radon mitigation specialist, the applicant shall:
5.3.a. Submit to the director an application on a form prescribed and provided by the director, which shall include information required by subdivisions 5.1.a. and 5.1.e. to 5.1.h. of this section;
5.3.b. Provide documentation that the applicant has successfully completed the training required by paragraph 5.1.c.1. of this section; and
5.3.c. Provide documentation that the applicant has passed the examination required by paragraph 5.1.c.2. of this section.
5.4. To apply for a license as a radon laboratory, the applicant shall:
5.4.a. Submit to the director an application on a form prescribed and provided by the director, which shall include the information required by subdivisions 5.1.a. and 5.1.e. to 5.1.h. of this section; and
5.4.b. Provide documentation that the applicant is on the United States Environmental Protection Agency's proficiency list or its equivalent.
5.5. To apply for a license to train radon testers and radon mitigators the applicant shall provide evidence that the training center has been approved to conduct radon testing or radon mitigation training by the United States Environmental Protection Agency.
5.6. An individual, business entity or government entity may hold more than one license. An applicant shall submit a separate application and pay a separate fee with each application, except a holder of a radon mitigation specialist license who is a business owner eligible for a radon mitigation contractor license under the provisions of W. Va. Code '16-34-5(c) is not required to pay the fee for the radon mitigation contractor license.
5.7. An application for licensure shall be accompanied by a nonrefundable check or money order.
W. Va. Code R. § 64-78-6 License Renewal
6.1. Each license issued under this rule is nontransferable and shall expire one year from the last day of the month in which it is issued. A license may be renewed by the director if an applicant applying for renewal:
6.1.a. Submits an application for renewal, including the licensee's number and appropriate information as required under subsections 5.1 to 5.5. of this rule; and
6.1.b. Submits the application for renewal no less than thirty (30) days before the expiration of the existing license.
6.2. An application for licensure renewal shall be accompanied by a nonrefundable check or money order.
6.3. The director shall issue a license after receiving the appropriate fee and the information requested in the application.
W. Va. Code R. § 64-78-7 Licensee Requirements
7.1. Licensed radon testers shall:
7.1.a. Operate in strict accordance with licensure requirements;
7.1.b. Obtain, in writing, from the director, approval for any change which would render the information submitted to obtain the original license inaccurate; and
7.1.c. Use only the services of a radon laboratory licensed by the director to analyze samples for the presence and concentration of radon.
7.2. Licensed mitigation specialists shall:
7.2.a. Operate in strict accordance with licensure requirements;
7.2.b. Afford the director the opportunity to inspect any radon mitigation project;
7.2.c. Maintain records of each radon mitigation project that the specialist has supervised or performed and make these records available to the director upon request. These records are maintained for a minimum of three (3) years and include the following:
7.2.c.1. The name and license number of the individual who supervised the radon mitigation;
7.2.c.2. The names and license numbers of all radon testers and mitigation specialists involved in the project;
7.2.c.3. The location and description of the project;
7.2.c.4. The radon measurements including the screening measurements, follow-up measurements and the post-mitigation measurements;
7.2.c.5. The start and completion dates of the project; and
7.2.c.6. A summary of the basic procedures that were used to reduce radon concentrations;
7.2.d. Report to the director once every three months the requirements of paragraphs 7.2.c.1. through 7.2.c.6. of this section.
7.3. Licensed radon mitigation contractors shall:
7.3.a. Comply with the requirements of subdivisions 7.1.a, 7.1.b. and
7.2.b. of this section;
7.3.b. Provide adequate equipment for worker protection to keep exposures to radon as low as reasonably achievable; and
7.3.c. Ensure that all radon testers, radon mitigators and radon laboratories involved in a project have a valid West Virginia license.
7.4. Licensed radon laboratories shall:
7.4.a. Report all State radon test results in picocuries per liter (pCi/l) to the director on a three(3)-month basis by city, street, and zip code; and
7.4.b. Maintain radon test results for a minimum of three years.
7.5. Holders of a radon training course license shall:
7.5.a. Comply with provisions of subdivision 7.1.b. of this section;
7.5.b. Issue a certificate of completion to each individual who successfully completes the courses; and
7.5.c. Submit to the director a list of all individuals who successfully complete the course.
W. Va. Code R. § 64-78-8 Special License Requirements
8.1. Special licensure requirements are as provided in W. Va. Code '16-34-4.
W. Va. Code R. § 64-78-9 Record Keeping and Confidentiality
9.1. The director shall maintain a list of all licensed radon testers, mitigation specialists, mitigation contractors, radon training facilities, and radon laboratories licensed by the state. On request, the director shall provide a copy of all or part of the list to any individual, business entity or government entity in accordance with the Division of Health=s Fees for Services rule, 64CSR51.
W. Va. Code R. § 64-78-10 Applications from Out of State Practitioners
Any individual, business entity or government entity that holds a valid license issued by another jurisdiction with requirements for practice as a radon tester, mitigation specialist or mitigation contractor as rigorous as those imposed by West Virginia, may apply for a license as a radon tester, mitigation specialist or mitigation contractor by providing the proper supporting documentation and paying the appropriate fee.
W. Va. Code R. § 64-78-11 Records Review
All licensees shall afford the director, at all reasonable times, the opportunity to examine records which are required to be maintained by the provisions of this rule.
W. Va. Code R. § 64-78-12 Reprimands, Suspensions or Revocation of Licenses, Orders, Hearings
12.1. W. Va. Code '16-34-13 governs reprimands, suspensions or revocations of licenses, orders and hearings.
12.2. Those persons adversely affected by the enforcement of this rule desiring a contested case hearing to determine any rights, duties, interests or privileges shall do so in a manner prescribed in the Division of Health=s rule, Rules and Procedures for Contested Hearings and Declaratory Rulings, 64 CSR 1.
W. Va. Code R. § 64-78-13 Penalties
13.1. W. Va. Code '16-34-14 governs penalties.
TABLE 64-78 A
LICENSURE FEE SCHEDULE
Type of License Fee Radon Contractor License for Renewal $ 100 Radon Mitigation Specialist License Or Renewal Fee 100 Radon Testers License or Renewal Fee 50 Radon Laboratory License or Renewal Fee 100 Radon Training Facility License or Renewal Fee 50 64CSR78
Series 80 Body Piercing Studio Business
W. Va. Code R. § 64-80-1 General
1.1. Scope. -- This legislative rule establishes requirements regarding the business of body piercing. This rule should be read in conjunction with the provisions of W. Va. Code '16-37-1 et seq.
1.2. Authority. -- W. Va. Code ''16-37-4 and 16-1-4.
1.3. Filing Date. -- May 4, 2001.
1.4. Effective Date. -- July 1, 2001.
1.5. Applicability. -- This rule applies to any person who engages in the business of body piercing, or who proposes to do so, except:
1.5.a. Health care providers licensed under Chapter Thirty (30) of the W. Va. Code; and
1.5.b. Persons who use a mechanized, pre-sterilized ear-piercing system that penetrates the outer perimeter or lobe of the ear.
1.6. Enforcement. -- This rule is enforced by the Director of the Division of Health.
W. Va. Code R. § 64-80-2 Definitions
2.1. Approved. -- A procedure of operation, installation or construction which is in accordance with the standards, specifications, and instructions established by the Division of Health.
2.2. Bloodborne Pathogens. -- Pathogenic microorganisms that are present in human blood and can cause disease in humans. These pathogens include, but are not limited to, hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV).
2.3. Blood Exposure Incident. -- Piercing the skin through such events as needle sticks, cuts, and abrasions from material contaminated with blood from a client, or eye, mouth, other mucous membrane, or non-intact skin contact with blood or blood-contaminated material from a client.
2.4. Contaminated. -- The presence or reasonably anticipated presence of blood, body fluids or other potentially infectious materials in or on the surface of an item.
2.5. Contaminated Waste. -- Material used in body piercing that requires disposal.
2.6. Director. B The Director of the Division of Health or his or her designee.
2.7. Exposure Control Plan. -- A written plan of procedures for those who perform body piercing in a facility on how to implement the requirements of this rule, and that eliminates or minimizes employee and client exposure to bloodborne pathogens and other communicable diseases.
2.8. Facility. B A room, shop, space or vehicle where body piercing is performed.
2.9. Instrument. -- Body piercing equipment that includes, but is not limited to needles, needle bars, needle tubes, forceps, hemostats, tweezers, pliers, or other implements used to pierce, or be inserted into any part of the human body for the intended purpose of making a permanent hole. The equipment also includes studs, hoops, rings, and other decorative jewelry, materials or apparatuses inserted into any part of the body for the intended purpose of placement in a hole resulting from piercing.
2.10. Minor. -- Any person under the age of 18 (eighteen) years.
2.11. Owner. -- A person that owns, controls or has custody of a place of business where body piercing is performed.
2.12. Permanent Hole. -- A hole produced by piercing or puncturing any part of the body with instruments intended to leave an opening in body tissue into which an appropriate device may be inserted. A permanent hole would include any body part newly pierced which is undergoing a healing process and any piercing whether removal of a device from the perforation would result in healing of the tissue or not.
2.13. Permit. -- A written document issued by the Director giving a person permission to operate a body piercing studio business.
2.14. Piercing Device. -- A device used for the creation of an opening in the human body for the purpose of inserting jewelry or other decoration.
2.15. Piercing Gun. -- A handheld tool used exclusively for piercing the ear, into which single use pre-sterilized studs and clutches are placed and inserted into the ear by hand squeezed or spring loaded action to create a permanent hole. The tool shall be made of plastic, stainless steel or other material that allows disinfection.
2.16. Procedure Area. -- The immediate area where instruments and supplies are placed during a procedure.
2.17. Purchased pre-sterilized. -- Instruments that are sold individually packaged and sterilized. Each package shall have an auditable sterilization lot number from a sterilization facility.
2.18. Sanitization. -- The effective bactericidal and virucidal treatment of clean equipment surfaces by a process that has been approved by the Director as being effective in destroying pathogens and different than sterilization.
2.19. Single Use. -- Products, instruments or items that are used one (1) time on one (1) client and then properly disposed of in accordance with the Division of Health rule, Infectious Medical Waste,@ 64CSR56.
2.20. Sterilization. -- The destruction of all living organisms including spores.
2.21. Workstation. -- An area such as a separate room or a screened area, that is set up to perform body piercing to insure privacy when performing nipple, genital or other discretionary piercing.
W. Va. Code R. § 64-80-3 Plan Review, Permits, Hearings, Notices and Orders, and Certificate of Registration
3.1. Plan Review.
3.1.a. When a Body Piercing Studio Business opens or is extensively remodeled, and when an existing structure is converted to use as a Body Piercing Studio Business, the owner or operator shall submit plans and specifications for the construction, remodeling, or conversion of the business to the Director for review and approval at least forty-five (45) days before beginning the construction, remodeling or conversion..
3.1.b. Once the completed plans are received by the Director, the Director shall review them within forty-five (45) days.
3.2. Permit to operate.
3.2.a. On or after July 1, 2001, no person shall operate a Body Piercing Studio Business who does not possess a valid permit issued to him or her by the Director.
3.2.b. To apply for a permit to operate a Body Piercing Studio Business, a person shall submit a completed, written application along with a non-refundable fee of two hundred dollars ($200.00) to the Director on a form obtained from the Director.
3.2.c. The applicant shall submit to the Director an application for a permit at least fifteen (15) days before the beginning of operations.
3.2.d. Prior to approving the application for a permit, the Director shall inspect the proposed facility to determine compliance with this rule. The Director shall issue a permit only to persons who comply with the applicable provisions of this rule.
3.2.e. A Body Piercing Studio Business in operation at the time this rule becomes effective shall meet all applicable requirements of this rule.
3.2.f. Permits are not transferable or assignable and automatically become invalid upon a change of ownership of the facility, or upon suspension or revocation of the permit.
3.2.g. A permit to operate expires at midnight on the thirtieth (30th) day of June following the date of issuance.
3.2.h. The permittee shall submit to the Director an application for the renewal of a permit at least fifteen (15) days prior to the expiration date of the existing permit.
3.2.i. In the event of a change in ownership of a facility, the new operator shall submit an application for a permit to operate to the Director at least fifteen (15) days before the change is effected.
3.2.j. The Director may suspend or revoke a permit if he or she finds that the facility is being maintained or operated in violation of this rule.
3.2.k. The Director may revoke a permit to operate for repeated or serious violations of any of the requirements of this rule or for interference with the Director in the performance of his or her duties.
3.2.l. The Director shall not reinstate a permit to operate until he or she determines by an inspection that the facility is in compliance with all applicable provisions of this rule and any orders, rules or instructions issued by the Director.
3.2.m. The operator shall post in a conspicuous place within the facility, the operational permit required under Subdivision 3.2.a. of this rule and the health department public notice attached to this rule, and the permit shall be readily available to the Director.
3.2.n. The operator shall post the operational permit required under Subdivision 3.2.a. of this rule beside the health department public notice attached to this rule in a conspicuous location visible to the public.
3.3. Hearings, Notices and Orders.
3.3.a. When the Director makes an inspection of a facility and discovers that any of the provisions of this rule have been violated, he or she shall notify the operator of the violations by means of an inspection report form or other written notice. The operator shall correct the violations within the time specified in the notice.
3.3.b. When the Director finds that any facility governed by this rule constitutes an imminent hazard to public health, he or she may, without notice or hearing, issue a written order to the operator or person in charge citing the existence of the condition and action to be taken to remedy the condition, including the immediate suspension of the permit to operate.
3.3.b.1. Any person to whom the order is directed shall comply with the order immediately, but upon written petition to the Director shall be afforded a hearing on the matter as set forth in subdivision 3.3.c. of this rule.
3.3.c. A person whose application for a permit to operate a facility governed by this rule has been denied, or whose permit has been suspended or revoked, may submit a written petition to the Director requesting a hearing on the matter in a manner prescribed in Rules of Procedure for Contested Case Hearings and Declaratory Rulings, 64 CSR 1. The Director shall grant a hearing on the matter within ten (10) days after he or she has received the written petition.
3.3.d. The filing of a petition for a hearing on a permit denial, suspension, or revocation shall not stay or suspend the execution of the notice or order resulting in the permit denial, suspension, or revocation.
3.4. Body Piercing Certificate of Registration.
3.4.a. All persons who perform or intend to perform body piercing shall hold a valid Body Piercing Certificate of Registration before performing any body piercing.
3.4.b. A Certificate of Registration is valid for one (1) year, shall be prominently displayed and visible to the public at the technician=s workstation and in every shop where the technician practices, and is not transferrable.
3.4.c. Certificate of Registration Requirements and Procedures.
3.4.c.1. The applicant for a Certificate of Registration shall be at least eighteen (18) years of age when he or she applies, and shall:
3.4.c.1.a. Submit a written request for a Certificate of Registration to the Bureau for Public Health, Office of Environmental Health Services, Charleston, WV 25301, and pay the Bureau the required fee of one hundred dollars ($100.00);
3.4.c.1.b. Obtain a copy of this rule and sign a written statement agreeing to comply with its provisions;
3.4.c.1.c. Provide the names and business addresses of all facilities at which the applicant shall perform any activity under this rule;
3.4.c.1.d. Provide written documentation that he or she has received exposure control training under the requirements in 64CSR29 '9; and
3.4.c.1.e. Provide written documentation of the applicant=s Hepatitis B Vaccination status in one of the following forms:
3.4.c.1.e.1. A certificate of a completed vaccination;
3.4.c.1.e.2. Laboratory evidence of immunity; or
3.4.c.1.e.3. A copy of a certificate of vaccination declination for Hepatitis B Vaccination that shall be kept on file in the body piercing studio business and made available during inspections.
3.4.d. Certificate of Registration Suspension. If the Director finds any unsafe practices or unsanitary conditions in the body piercing studio business licensed under this rule that constitute an imminent danger to the public health, the Director may:
3.4.d.1. Immediately suspend the technician=s Certificate of Registration and all body piercing procedures done in that body piercing studio;
3.4.d.2. Serve an order upon the technician, owner or manager citing the unsafe practices and conditions found, and specifying the corrective action to be taken within fifteen (15) days; or
3.4.d.3. Suspend the Certificate of Registration if the violations are not corrected within fifteen (15) days. The person to whom the order is issued may send a written request to the Director for a review of the violation report, and the review shall be held within fifteen (15) days.
3.4.e. Certificate of Registration Revocation. The Director may be revoke the Certificate of Registration at any time after due process.
W. Va. Code R. § 64-80-4 Inspections
4.1. The Director is charged with the enforcement of all provisions of this rule. The Director may enter, inspect, impound, copy records, and secure any samples, photographs, or other evidence from any body piercing shop, or any facility suspected of being a body piercing shop, for the purpose of enforcing this rule.
4.2. The Director shall inspect a facility governed by this rule at least once a year.
4.3. The Director shall also make additional inspections as necessary to determine satisfactory compliance with the provisions of this rule or any orders, notices, instructions or specifications issued pursuant to this rule.
4.4. The Director shall discuss the inspection report with the person in charge of the facility at the time of inspection.
4.5. Facility Owner Responsibilities.
4.5.a. The facility owner or operator of any body piercing facility shall:
4.5.a.1. Allow the Director or his or her designee to enter any body piercing shop within his or her jurisdiction during business hours to inspect the facility, and make as many additional inspections as are necessary for the enforcement of this rule;
4.5.a.2. Be responsible for all facility technicians complying with all health, safety, sanitation and sterilization rules and standards of the Director;
4.5.a.3. Maintain a list of technicians providing services at the facility for review by the Director during inspections; and
4.5.a.4. Develop and ensure compliance with the Exposure Control Plan as specified in Section 13 of this rule. A copy of the plan shall be available at all times for use and inspection.
W. Va. Code R. § 64-80-5 Facility Requirements
5.1. All floors, walls and ceilings shall be made of smooth nonabsorbent and nonporous material that are easily cleanable. Concrete blocks or other masonry used in wall construction shall be covered or made smooth and sealed for a washable surface.
5.2. Adequate toilet facilities shall be provided in accordance with the specifications of the BOCA National Plumbing Code as specified by the West Virginia State Fire Commission. A hand sink shall be located inside the restroom facility and shall be supplied with liquid hand cleanser and single use paper towels or any other approved hand-drying device.
5.3. The premises shall be constructed and maintained in a state of good repair at all times to prevent insect and rodent infestation.
5.4. Body piercing activities shall be separated from any other activities by a solid wall.
5.5. The establishment shall be well ventilated and be provided with an artificial light source equivalent to at least twenty (20) foot-candles.
5.6. At least fifty (50) foot-candles of artificial light shall be provided at the level where the body piercing procedure is being performed.
5.7. All surfaces, including but not limited to, counters, tables, equipment, chairs, recliners, shelving, cabinets in the service areas and cleaning room shall be made of smooth, non-absorbent, non-porous materials to allow for easy cleaning.
5.8. Hand sinks with hot and cold running water operated by wrist or knee action shall be located in each work area. If there are two (2) or more work stations within a room, all may share the hand sink. A work station in a separate room shall include a hand sink.
5.9. The cleaning room or area shall have a separate sink reserved for instrument clean up activities only.
5.10. The water supply shall be from an approved source.
5.11. Sewage including liquid wastes shall be disposed of in a public sewer or, in the absence of a public sewer, in a manner approved by the Director.
W. Va. Code R. § 64-80-6 Temporary and Mobile Facilities
6.1. Temporary facilities include those for educational or convention purposes. To the extent possible, they shall meet the facility requirements in Section 10 of this rule. At a minimum, they shall include:
6.1.a. Temporary handwash facilities and hand sanitizer located within each work or demonstration area. A temporary handwash facility shall consist of liquid hand cleanser, single-use paper towels and warm potable water dispensed from an insulated container with a spigot that is raised a minimum of twenty-five (25) inches off the floor. Wastewater shall be collected in a bucket placed on the floor under the spigot. Warm potable water shall be replenished and wastewater removed as necessary;
6.1.b. At least fifty (50) foot-candles of light at the level where the procedure is being performed;
6.1.c. A separate cleaning and sterilization area for use by the participants that supplies an adequate number of sinks and Director approved sterilization units for cleaning and sterilizing equipment to be used during the event; and
6.1.d. Sterilization units approved by the Director that are used, cleaned and maintained according to manufacturer's instructions. All sterilization units used at the event shall have certification of a negative spore test on the sterilizer within the last thirty (30) days.
6.2. Mobile units or vehicles shall comply with the following requirements:
6.2.a. The mobile vehicle shall be equipped with a sink for the exclusive use of the technicians for hand washing and preparing customers. An adequate supply of potable water shall be maintained at all times that the mobile shop is open for business;
6.2.b. All liquid wastes shall be stored in an adequate storage tank with a capacity at least fifty percent (50%) greater than the capacity of the on-board potable water. Liquid wastes shall be disposed of at any approved trailer wastewater disposal site;
6.2.c. If there is not an on-board rest room, the mobile vehicle shall be operated within two hundred (200) feet of a public restroom; and
6.2.d. All procedures shall be performed inside the mobile vehicle.
W. Va. Code R. § 64-80-7 Housekeeping Standards
7.1. All body piercing studio businesses shall meet the following criteria:
7.1.a. All areas shall be kept neat, clean and in good repair;
7.1.b. All surfaces and equipment (chairs, work stations, counters, client recliners or dispensers) in the procedure area shall be made of smooth, non absorbent, non-porous material that can withstand repeated disinfection;
7.1.c. An Environmental Protection Agency (EPA) registered disinfectant or germicide (iodophor, phenolic, or alcohol containing germicide, or a 1:100 dilution of 5.25% household bleach and water which equals two (2) tablespoons of bleach in one (1) quart of water) shall be used after cleaning to disinfect any surface contaminated with blood or body fluids;
7.1.d. All facilities shall have the waiting area separated from the workstations and the cleaning room or area. A public restroom shall be available to clients during all business hours;
7.1.e. The cleaning room or area shall be set up in a manner to provide distinct, separate areas for cleaning equipment, and for the handling and storage of sterilized equipment. The cleaning area sink shall be reserved for instrument cleaning only and shall not be used as a janitorial sink;
7.1.f. Large capacity ultrasonic cleaning units shall be clearly labeled biohazardous and placed away from the sterilizer and workstations. All ultrasonic cleaners shall be cleaned and maintained according to manufacturer's specifications;
7.1.g. Adequate foot-operated receptacles shall be provided in each workstation for disposal of trash and debris;
7.1.h. Each work station shall have a Director approved sharps container that is rigid, puncture proof, leak proof and red in color for disposal of sharp objects that come into contact with blood or body fluids;
7.1.i. The procedure area and client chair or table shall be wiped down with an EPA registered disinfectant or germicide using a single-use paper towel before and after serving each client;
7.1.j. All germicides and disinfectants must be used according to manufacturer's recommendations;
7.1.k. All chemicals shall be properly labeled and stored; and
7.1.l. Pets or other animals are not be permitted in the facility. Trained guide or assistance animals for the disabled and fish in aquariums in the waiting area are permitted in the facility.
W. Va. Code R. § 64-80-8 Exposure Control Plan
8.1. The owner of every body piercing studio business shall establish a written Exposure Control Plan which applies to all technicians within a facility, and describes how the applicable requirements of this rule shall be implemented. This plan shall be made available to the Director during any inspection. The Exposure Control Plan shall contain at least the method of implementation for each of the following applicable sections of this rule:
8.1.a. Section 13. Clients;
8.1.b. Section 5. Facility Requirements;
8.1.c. Section 7. Housekeeping Standards;
8.1.d. Section 10. Approved Sterilization Equipment and Monitoring Methods;
8.1.e. Section 11. Instrument Sterilization and Set-Up;
8.1.f. Section 12. Contaminated Wastes; and
8.1.g. Section 14. Body Piercing.
W. Va. Code R. § 64-80-9 Exposure Control Training Requirements
9.1. All technicians shall receive exposure control training.
9.2. All technicians shall complete the exposure control training within one (1) year of the effective date of this rule and shall update the training at least every three (3) years thereafter. The technicians shall complete additional training when changes such as modification of procedures or institution of new procedures affect the technician=s or client's exposure. The additional training may be limited to addressing the new exposures created.
9.3. The trainees shall use material appropriate in content and vocabulary to their educational and language level.
9.4. The training program shall contain, at a minimum, the following elements:
9.4.a. An accessible copy of the this and any other applicable rules and an explanation of their contents;
9.4.b. A general explanation of the epidemiology and symptoms of bloodborne diseases and any other exposures appropriate for the practice of the technician;
9.4.c. An explanation of the modes of transmission of bloodborne pathogens and other communicable diseases appropriate for the technician;
9.4.d. An explanation of the appropriate methods for recognizing tasks and other activities that may involve exposure to blood for either the technician, the client, or both;
9.4.e. An explanation of the use and limitations of methods that will prevent or reduce exposure to both the technician and the client;
9.4.f. Information on the types, proper use, and removal, of gloves and proper hand washing techniques;
9.4.g. Information on hepatitis B vaccine, including information on its efficacy, safety, method of administration, and the benefits of being vaccinated;
9.4.h. An explanation of what constitutes a blood exposure incident, the risk of disease transmission following a blood exposure incident, and the options for post-exposure evaluation and follow-up if an exposure incident occurs, specific to each bloodborne pathogen; and
9.4.i. An opportunity for interactive questions and answers with the person conducting the training session.
9.5. The person conducting the training shall be knowledgeable in the subject matter covered by the training program as it relates to the workplace that the training will address.
9.6. The following courses are considered adequate training for obtaining a Body Piercer Certificate of Registration:
9.6.a. The American Red Cross course on Preventing Disease Transmission;
9.6.b. The OSHA course on Bloodborne Pathogen Training; and
9.6.c. Equivalent training provided by professional body art organizations or equipment manufacturers.
W. Va. Code R. § 64-80-10 Approved Sterilization Equipment and Monitoring Methods
10.1. The operator shall ensure that the instruments used in body piercing are properly cleaned and packaged in sterilizer bags with a color change indicator and then sterilized in a sterilizer that:
10.1.a. Is sold as sterilizing equipment for medical instruments;
10.1.b. Has been approved by the Department;
10.1.c. Is used, cleaned and maintained to manufacturer's specifications; and
10.1.d. Is tested at least monthly (unless otherwise specified by the manufacturer) by using a commercial biological monitoring system, utilizing Bacillus stearothermophilus spores, to assure that all microorganisms, including spores, have been destroyed. The operator shall maintain biological indicator test results for a period of three (3) years and make them available for inspection at all times.
W. Va. Code R. § 64-80-11 Instrument Sterilization and Set-Up
11.1. Contaminated non-disposable equipment including needles, needle bars, needle tubes, needle caps, body piercing tubes or other instruments that are contaminated shall be immersed in liquid in the cleaning area or room until cleaned and sterilized.
11.2. Before being sterilized, all instruments shall be thoroughly cleaned in an ultrasonic cleaner following the manufacturer's instructions.
11.3. After cleaning, non-disposable instruments shall be packaged into procedure set-ups with color change indicators or packaged individually in peel-packs with color change indicators. All packages shall be dated and initialed by the preparer. If a sterilized package has been breached or allowed to get wet, the instruments shall be re-packaged and re-sterilized before use.
11.4. After sterilization, the instruments shall be stored in a dry, clean cabinet or other tightly covered container reserved for storage of sterile instruments.
11.5. The facility shall retain the records of sterilization procedures for a minimum of the last three (3) years.
11.6. Wearing new clean disposable examination gloves, the technician shall use the proper technique to assemble, without contamination, all instruments and supplies to be used in the procedure. All sterilized instruments shall remain in sterile packages until opened in front of the client. If a glove is pierced, torn or contaminated by contact with any non-clean surface, the technician shall properly remove and discard both gloves. The technician shall discard the gloves after the completion of each procedure on an individual client, and shall wash his or her hands prior to donning the next pair of gloves. Under no circumstances shall a single pair of gloves be used on more than one (1) person. The use of disposable examination gloves does not preclude or substitute for hand washing procedures as a part of a good personal hygiene program.
W. Va. Code R. § 64-80-12 Contaminated Wastes
12.1. Contaminated wastes generated by a body piercing studio business shall be managed in accordance with the Division of Health rule, Infectious Medical Waste,@ 64CSR56.
W. Va. Code R. § 64-80-13 Clients
13.1. A person under the age of eighteen (18) years may receive body piercing provided he or she is accompanied by his or her parent or guardian. The parent or guardian shall have valid picture identification. Nipple and genital piercing is prohibited on minors regardless of parental consent. Persons eighteen (18) years or older may receive body piercing without parental consent.
13.2. A technician shall not perform body piercing on skin surfaces which have sunburn, rash, pimples, infection, open lesions, or manifest any evidence of unhealthful conditions.
13.3. A technician shall not perform body piercing on any person who is impaired by drugs or alcohol at the time of the intended piercing.
W. Va. Code R. § 64-80-14 Body Piercing Procedures
14.1. Before beginning any body piercing procedure, the technician shall discuss the risks and responsibilities required in the particular piercing with the client, The client shall fill out and sign a client information form and the consent form for body piercing. One copy of each form shall be retained by the facility and the other copy shall be given to the client. The technician shall also explain aftercare instructions and have the client initial the consent form to indicate that he or she has received written aftercare instructions.
14.2. The technician shall not smoke, eat or drink at the work station or cleaning room during or between procedures. The client may consume a pre-packaged beverage or snack.
14.3. The technician shall thoroughly wash his or her hands and forearms with soap and warm water before and after serving each client, to prevent cross contamination and/or transmission of body fluids, infection or exposure to service related chemicals or wastes. Following a thorough washing, the technician shall dry his or her hands using clean, single use paper towels.
14.4. The technician shall wear new clean disposable examination gloves for every client during the procedure. If a glove is pierced, torn or contaminated by coming into contact with any other person or non-clean surface, the technician shall properly remove and discard both gloves.
14.5. The technician shall use freshly laundered linens or new disposable dental bibs or drapes for each client. All drapes, dental bibs, and linens shall be stored in a closed cabinet or container. The technician shall place used disposable items into a closed container that is lined with a plastic bag for disposal at the end of the day, and place used linens into a laundry hamper lined with a plastic bag.
14.6. All body piercing needles shall be single use, sterilized disposable piercing needles slightly larger or of the same gauge as the jewelry or ornaments to be inserted, and disposed of immediately after use in a sharps container.
14.7. All instruments, as defined in Section 2 of this rule, shall be properly cleaned and sterilized in individual bags with color indicator strips. The person preparing the instruments shall date and initial each bag. The Director shall approve the sterilizers used.
14.8. All non-sterilizable implements such as calipers shall be nonporous and the technician shall disinfect them after each use with an appropriate disinfectant.
14.9. A technician shall use only pre-sterilized jewelry or ornaments in new or good condition for piercing. He or she shall not use ear studs or other jewelry designed for ears or specific parts. in other parts of the body.
14.10. The technician shall only use jewelry made of implant grade, ASTM and ISO 5832-1 implant grade stainless steel, solid 14K through 24K gold, niobium, titanium, platinum or other materials approved by the Director, in newly pierced skin.
14.11. Immediately, before the procedure is begun, the technician shall wipe down the procedure area with an EPA registered germicide or disinfectant, or a solution of two (2) tablespoons of five and one quarter percent (5 1/4 %) available chlorine bleach in one (1) quart of water and the procedure area covered with an uncontaminated paper towel or tray cover, and then arrange on the paper all instruments and supplies needed for the procedure.
14.12. Before piercing, the technician shall wash the immediate and surrounding area of the skin which is to be pierced with an EPA-approved antiseptic solution applied with a clean, single-use paper product. If shaving is necessary, the technician shall use one (1) time each disposable razors, or safety razors with single-service blades and discard them after each use; he or she shall sterilize the reusable holder in an autoclave after each use. Following the shaving, the technician shall wash the skin and surrounding area with an EPA-approved antiseptic solution applied with a clean single-use paper product.
14.13. Upon completion of the piercing, the technician shall review verbally with the client the printed instructions on the care of the body opening created by the piercing. Aftercare instructions shall specify:
14.13.a. Care specific to the site of the piercing;
14.13.b. Information regarding tightness to prevent accidental ingestion or imbedding of certain jewelry if appropriate;
14.13.c. Restrictions;
14.13.d. Signs and symptoms of infection; and
14.13.e. Instructions to consult a physician if infection occurs.
W. Va. Code R. § 64-80-15 Records
15.1. Every Body Piercing Studio Business shall keep a record of all body piercing procedures performed for a period of three (3) years. The record shall include:
15.1.a. The client=s name;
15.1.b. The client=s date of birth;
15.1.c. The client=s address;
15.1.d. The date of the procedure;
15.1.e. The type and location of each procedure performed;
15.1.f. The name of the technician who performed each procedure;
15.1.g. The signature of the client; and
15.1.h. In the case of a minor, the proof of parental or guardian presence and written consent.
15.2. The body piercing studio business shall maintain signed copies of the client Release Form and Aftercare Form. These forms shall provide:
15.2.a. Verification that the client was given written and oral notification of the risks associated with body piercing; and
15.2.b. Verification that the client was given written and oral instructions on post piercing skin care.
15.3. All records shall be available for inspection by the Director.
'16-29-16. Violations and Penalties.
16.1. The penalty for violation of the provisions of this rule are established in W. Va. Code '16-37-5.
W. Va. Code R. § 64-80-17 Administrative Due Process
17.1. Those persons adversely affected by the enforcement of this rule desiring a contested case hearing to determine any rights, duties, interests or privileges may do so in accordance with the Division of Health rule, ARules of Procedure for Contested Case Hearings and Declaratory Rulings,@ 64CSR1.
Public Notice 64-80A Public Notice Body Piercing Disclosure Statement ( THE WEST VIRGINIA BUREAU FOR PUBLIC HEALTH AND YOUR LOCAL HEALTH DEPARTMENT DO NOT ENDORSE OR RECOMMEND BODY PIERCING IN ANY FORM.
( HEALTH DEPARTMENT PERMITS SIGNIFY SANITATION OF EQUIPMENT AND THE UTILIZATION OF PROPER PROCEDURES ONLY.
As with any invasive procedure, body piercing may involve possible health risks. Body piercing could result in:
Pain, bleeding, swelling, infection, scarring of the pierced area and nerve damage.
The Piercing Technician should:
Properly cleanse the piercing site before piercing;
Use sterilized equipment;
Use sterile piercing techniques; and Inform the client of proper aftercare of the pierced area.
For complaints or comments please contact the Bureau for Public Health at (304) 558-2981, your local health department, or mail comments to 1 Davis Square, Suite 200, Charleston, WV 25301-1798.
The Department of Health and Human Resources (DHHR) was created by the Legislature's reorganization of the executive branch of State government in 1989. The Department of Health was renamed the Division of Health and made a part of the DHHR (W. Va. Code ' 5F-1-1 et seq.). Administratively within the DHHR the Bureau for Public Health through its Commissioner carries out the public health function of the Division of Health.
64CSR80
Series 81 Birth Defects Information System
W. Va. Code R. § 64-81-1 General
1.1. Scope. -- This rule establishes and implements a statewide birth defects information system for the collection and reporting of congenital anomalies and abnormal conditions. This rule should be read in conjunction with W. Va. Code §§16-1-18 and 16-40-1 et seq. The W. Va. Code is available in public libraries and on the Legislature’s web page, http://www.legis.state.wv.us/.
1.2. Authority. -- W.Va. Code §§16-1-4 and 16-40-7.
1.3. Filing Date. -- April 29, 2004.
1.4. Effective Date. -- April 29, 2004.
W. Va. Code R. § 64-81-2 Application and Enforcement
2.1. Application. -- This rule applies to all infants born in West Virginia and to the health care providers caring for children at birth and up to the age of six (6) that are diagnosed with a congenital anomaly or abnormal condition based upon national standards.
2.2. Enforcement. -- This rule is enforced by the commissioner of the bureau for public health.
W. Va. Code R. § 64-81-3 Definitions
3.1. Advisory Council. -- The committee appointed pursuant to W. Va. Code §16-40-6 to advise on the establishment and implementation of the birth defects information system.
3.2. Birth Defects Information System -- The data base that contains individual case demographic and diagnostic information maintained by the Office of Maternal, Child and Family Health within the Bureau for Public Health.
3.3. Congenital Anomaly and Abnormal Condition. -- An abnormality of the body’s structure or inherent function present at birth, whether the abnormality is detected at the time of delivery or becomes apparent at a later date.
3.4. Freestanding Birthing Center. -- A health care facility in which births routinely occur, that is not licensed under W. Va. Code §§16-5B-1 et seq.
3.5. Health Care Providers. -- A physician, or his or her designee, at any medical facility including, but not limited to private clinics, health departments and hospitals.
3.6. Hospital. -- A facility licensed as a hospital pursuant to W. Va. Code §§16-5B-1 et seq. and Welch Emergency Hospital.
3.7. Nurse-Midwife. -- An individual authorized under W. Va. Code §30-15 to practice nurse-midwifery.
W. Va. Code R. § 64-81-4 Reporting Requirements
4.1. Each physician, nurse-midwife, hospital and freestanding birthing center shall provide information to the birth defects information system on all patients up to the age of six (6) that have been diagnosed with a congenital anomaly or abnormal condition.
4.1.a. The commissioner may not require the reporting of personal identifying information or enter into the system any personal identifying information regarding congenital anomalies or abnormal conditions of a child whose parent or legal guardian objects on the basis of religious beliefs according to W. Va. Code §16-40-2.
4.2. The information shall be provided on forms obtained from the Office of Maternal, Child and Family Health in the Bureau.
4.3. Cases to be included in the information system shall consist of the International Classification of Diseases (ICD) diagnoses. After the information is submitted, the advisory council shall recommend the following types of cases that are reportable to the information system based on national standards.
ICD CODE
DIAGNOSIS
All Congenital Anomalies (740-759) (Reports would include 4th and 5th digit attachments, i.e. 740.0 or 743.30)
Anencephalus and similar anomalies Spina Bifida Other congenital anomalies of nervous system Congenital anomalies of eye Congenital anomalies of ear, face and neck Bulbus cordis anomalies and anomalies of cardiac septal closure Other congenital anomalies of heart Other congenital anomalies of circulatory system Congenital anomalies of respiratory system Cleft palate and cleft lip Other congenital anomalies of upper alimentary tract Other congenital anomalies of digestive system Congenital anomalies of genital organs Congenital anomalies of urinary system Certain congenital musculoskeletal deformities Other congenital anomalies of limbs Other congenital musculoskeletal anomalies Congenital anomalies of the integument Chromosomal anomalies Other and unspecified congenital anomalies Specified Conditions in the Perinatal Period (760-763) (including 4th and 5th digit attachments, i.e., 765.2 or 765.20)
760.71 Fetal Alcohol Syndrome Slow fetal growth and fetal malnutrition Disorders relating to short gestation and low birthweight Disorders relating to long gestation and high birthweight
4.4. If a child’s parent or legal guardian wants information concerning the child removed from the birth defects information system for religious reasons:
4.4.a. The commissioner shall remove all identifying information from the record, but leave the case in the system for reporting purposes; and
4.4.b. A form for the parent or legal guardian to complete for the removal of the child’s identifying information shall be mailed to all birthing facilities and made available upon request at the Bureau for Public Health office and on the Bureau’s web page: http://www.wvdhhr.org/.
W. Va. Code R. § 64-81-5 Confidentiality
5.1. Only those persons employed by the Bureau for Public health dealing specifically with the birth defects registry shall have access to the database. All others requesting data from the registry shall complete a request form detailing what information is requested and how it shall be used. The person requesting the information then shall be given compiled data with no identifying information attached.
5.2. Anyone who obtains confidential information while implementing W. Va. Code §§16-40-1 et seq. may disclose it only to reporting sources, persons demonstrating a need that is essential to health related research or care of persons with congenital anomalies and abnormal conditions, or as required or permitted by law.
5.3. Anyone who obtains confidential information while implementing W. Va. Code §§16-40-1 et seq. shall provide a written statement to the commissioner that he or she fully understands the confidentiality of the information and will maintain it.
5.4. The commissioner may publish reports with statistical data relating to birth defects and other adverse birth outcomes that do not in any manner identify individual patients or individual sources of information are permissible, provided that the data is not for such small geographic areas or in categories with few entries that together with other publicly available information, the patients could be identified.
W. Va. Code R. § 64-81-6 Penalties
6.1. Anyone who violates the provisions of W. Va. Code §§16-40-1 et seq. or this rule is subject to the penalties in W. Va. Code §§16-1-17 and -18.
Series 82 Needlestick Injury Prevention
W. Va. Code R. § 64-82-1 General
1.1. Scope -- This legislative rule establishes specific standards and procedures concerning needlestick injury prevention; creates a needlestick injury prevention program in hospitals, nursing homes, public health departments and home health agencies, including those staffed by public employees; makes compliance with rules a condition of licensure; establishes requirements for facilities to use needleless systems; relates to keeping sharps injury logs; requires the maintainment of a list of existing needleless systems; sets forth exceptions to requirements; and other matters pertinent and necessary for the implementation of the Needlestick Injury Prevention Program, W. Va. Code '16-36-1 et seq. This rule supplements the Needlestick Injury Prevention Program, W. Va. Code '16-36-1 et seq., and should be read in conjunction with the Act.
1.2. Authority. -- W. Va. Code '16-36-2.
1.3. Filing Date. -- May 10, 2001.
1.4. Effective Date. -- July 1, 2001.
W. Va. Code R. § 64-82-2 Application and Enforcement
2.1. Application -- This rules applies to:
2.1.a. Every hospital licensed under the provisions of W. Va. Code '16-5B-1 et seq.;
2.1.b. Every nursing home licensed under the provisions of W. Va. Code '16-5C-1 et seq.
2.1.c. Every local health department;
2.1.d. Every home health agency certified by the office of health facility licensure and certification;
2.1.e. All hospitals and nursing homes operated by the state or any agency of the state; and
2.1.f. All hospitals, nursing homes, local health departments and home health agencies which are staffed in whole or in part by public employees.
2.2. Enforcement -- This rule is enforced by the director of the division of health or his or her lawful designee.
W. Va. Code R. § 64-82-3 Definitions
3.1. Annual Report. -- A quality improvement report, submitted to the director on a yearly basis, including a summary of trends in needlestick injuries and suggestions as to whether or how protective mechanisms or work practice control could be utilized to prevent the injuries.
3.2. Contaminated. -- The presence or the reasonably anticipated presence of blood or other potentially infectious materials on a surface or in or on an item.
3.3. Engineered Sharps Injury Protection.
3.3.a. A physical attribute built into a needle device used for withdrawing body fluids, accessing a vein or artery, or administering medications or other fluids, which effectively reduces the risk of an exposure incident by a mechanism such as barrier creation, blunting, encapsulation, withdrawal or other effective mechanisms; or
3.3.b. A physical attribute built into any other type of needle device, or into a non-needle sharp, which effectively reduces the risk of an exposure incident.
3.4. Engineering Controls. -- Sharps prevention technology including, but not limited to, systems not using needles and needles with engineered sharps injury protection that isolate or remove the bloodborne pathogens hazard from the workplace.
3.5. Exposure incident. -- A specific eye, mouth, or other mucous membrane, non-intact skin, or parenteral contact with blood or other potentially infectious materials that results from the performance of an employee=s duties.
3.6. HBV. -- Hepatitis B virus.
3.7. HCV. -- Hepatitis C virus.
3.8. HIV. -- Human immunodeficiency virus.
3.9. Occupational Exposure. -- Reasonably anticipated skin, eye, mucous membrane, or parenteral contact with blood or other potentially infectious materials that may result from the performance of an employee=s duties.
3.10. Protective Equipment. -- Specialized clothing or equipment worn by an employee for protection against a hazard. General work clothes (e.g., uniforms, pants, shirts, or blouses) not intended to function as protection against a hazard are not considered to be protective equipment.
3.11. Quarterly Report. -- A quarterly supplement to the annual report, reported to the director, containing the specific information of each exposure incident as set forth in section five of this rule and a cover sheet with patterns of needlestick and sharps injuries that the facility has identified.
3.12. Sharps. -- Any object used or encountered by a health care worker that can be reasonably anticipated to penetrate the skin or any other part of the body, and to result in an exposure incident, including, but not limited to, hollow-bore needles or sharp instruments, including, but not limited to, needles, lancets, and scalpels.
W. Va. Code R. § 64-82-4 Use of Needleless Systems or Other Engineering Controls
4.1. Facilities shall use needleless systems for:
4.1.a. Withdrawal of body fluids after initial venous or arterial access is established;
4.1.b. Administration of medications or fluids; and
4.1.c. Any other procedure involving the potential for an exposure incident for which a needleless system or other engineering control is available as an alternative to the use of needle devices.
4.1.d. Facilities are not required to use a needleless system, provided, that the requirements of the Occupational Exposure to Bloodborne Pathogens; Needlesticks and Other Sharps Injuries; Final Rule, 29CFR Part 1910, www.osha-slc.gov/needlesticks/index.html, attached hereto as appendix 1 are met;
4.1.d.1. In cases where the facility can demonstrate circumstances in which the technology does not promote employee or patient safety or interferes with a medical procedure;
4.1.d.2. In circumstances where the technology is medically contraindicated or where the facility demonstrates by means of objective product evaluation criteria that the use of the technology is not more effective than alternative measures used by the facility to prevent exposure incidents;
4.1.d.3. In cases where the employer shows that no needleless systems or engineered sharps injury protection devices are available in the marketplace for a medical procedure because of limits in supply or in technology;
4.1.d.4. In circumstances in which the employer shows that sufficient information is not available on safety performance of needleless systems or sharps devices with engineered protection available in the marketplace and the employer is actively evaluating the devices;
4.1.d.5. In circumstances in which health care employees involved in patient=s care determine, in the reasonable exercise of their clinical judgement, that use of the engineering control will jeopardize the patient=s safety or the success of a medical nursing procedure involving the patient.
4.2. If needleless systems are not used, needles with engineered sharps injury protection shall be used for:
4.2.a. Withdrawal of body fluids;
4.2.b. Accessing a vein or artery;
4.2.c. Administration of medications or fluids; and
4.2.d. Any other procedure involving the potential for an exposure incident for which a needle device with engineered sharps injury protection is available.
4.3. If sharps other than needle devices are used, these items shall include engineered sharps injury protection.
W. Va. Code R. § 64-82-5 Sharps Injury Log
5.1. A facility shall record information concerning exposure incidents in a sharps injury log, to be kept within the facility, which shall include:
5.1.a. The date and time of the exposure incident;
5.1.b. The type and brand of sharp involved in the incident if known; and
5.1.c. A complete description of the exposure incident including the following information:
5.1.c.1. The job classification of the exposed worker;
5.1.c.2. The department or work area where the exposure incident occurred;
5.1.c.3. The procedure or task that the exposed worker was performing at the time of the incident;
5.1.c.4. How the incident occurred;
5.1.c.5. The body part involved in the exposure incident;
5.1.c.6. If the sharp had engineered sharps injury protection, whether the protective mechanism was activated and whether the injury occurred before the protective mechanism was activated, during activation of the mechanism, or after activation of the mechanism, if applicable; and,
5.1.c.7. Any suggestions by the injured employee as to whether or how protective mechanisms or work practice control could be utilized to prevent the injuries.
5.2. The sharps injury log shall not contain any personal identifiers, including, but not limited to, the injured employee=s name, age, date of birth, social security number, or address.
5.3. Recording; Reporting.
5.3.a. The facility shall record the exposure incident on the log within six (6) working days of the date the incident is reported to the employer.
5.3.b. The facility shall prepare an annual report of needlestick injuries within the facility, to be reported to the director, including a quality improvement report based on the data from the quarterly reports. The quality improvement report shall include a summary of trends in needlestick injuries and suggestions as to whether or how protective mechanisms or work practice control could be used to prevent these injuries.
5.3.c. Facilities shall supplement the annual report with quarterly reports to be submitted to the director within thirty days (30) of the close of each quarter. The quarterly reports shall contain the specific information of each exposure incident as set forth in section five of this rule and any patterns of needlestick and sharps injuries that the facility has identified.
5.3.d. The reports required by this rule may be made electronically in a manner approved by the director, or in a form stipulated by the director.
W. Va. Code R. § 64-82-6 List of Needleless Systems and Needles with Engineered Injury Protections
6.1. The division of health shall maintain a list of existing needleless systems and needle and sharps with engineered injury protection. The director shall make the list available to assist employers in complying with the requirements of the standards adopted under W. Va. Code '16-36-1 et seq. and this rule. The division of health shall review and update the list annually.
6.2. The list may be developed from existing sources of information, including but not limited to, the federal Food and Drug Administration, the federal Centers for Disease Control, the National Institute of Occupational Safety and Health, the United States Department of Veterans Affairs and product usage experience of hospitals.
6.3. Characteristics of needles and sharps with engineered injury protection shall include but not be limited to:
6.3.a. Devices that provide a barrier between the hands and the sharp after use;
6.3.b. Devices that allow or require the health care employees= hands to remain behind the sharp at all times;
6.3.c. An engineering control mechanism that is an integral part of the device and does not need to be added for use;
6.3.d. Devices that are simple and self evident to operate and require little or no training for effective use;
6.3.e. An engineering control mechanism that either requires no activation by the user, or has a safety feature can be engaged with a single-handed technique and allows the worker=s hands to remain behind the exposed sharp;
6.3.f. A device that enables the user to easily tell whether the safety feature is activated;
6.3.g. Devices that perform reliably;
6.3.h. Devices that are easy to use and practical;
6.3.i. Devices that are safe and effective for patient care; and
6.3.j. An engineering control mechanism that is integrated with the sharp after use and remains in effect after disposal to protect health care employees.
W. Va. Code R. § 64-82-7 Training
7.1. Facilities shall provide a training program to all health care employees who are at risk for occupational exposure which they shall participate in during working hours at no cost to the health care employees.
7.2. The person conducting the training shall be knowledgeable in the subject matter covered by the elements contained in the training program as it relates to the workplace that the training will address.
7.3. The training shall take place at the time of implementation of a new device and during initial hire orientation of all applicable employees.
7.4. The needlestick injury prevention advisory committee shall set forth specific guidelines and recommendations for the specific areas that the training shall cover.
7.5. The facility shall maintain records of the training of health care employees for three (3) years from the date on which the training occurred or according to facility policy whichever is more stringent.
W. Va. Code R. § 64-82-8 Vaccinations
8.1. The employer shall ensure that all health care employees who have declined to accept hepatitis B vaccination be offered a hepatitis vaccination series annually thereafter.
8.2. If a routine booster dose of hepatitis B or other vaccines for HCV or HIV are recommended by the U.S. Public Health Service at a future date, the employer shall make the booster dose or vaccination series available to the health care employee at no cost.
W. Va. Code R. § 64-82-9 Protective Equipment
9.1. All health care employees shall use appropriate protective equipment when occupational exposure can be reasonably anticipated.
9.2. Facilities shall provide appropriate protective equipment to their health care employees at no cost.
W. Va. Code R. § 64-82-10 Placement of Sharps Containers
10.1. Sharps disposable containers should be strategically located and placed so as to be easily visible and to avoid overfilling; they should be within easy horizontal reach of the user. Systems should have secure locking and enable easy replacement. When containers are fixed to a wall, the vertical height should allow the worker to view the opening or access to the container.
10.2. The division of health, shall as part of its review of sharps injury logs, determine whether injuries have occurred due to a lack of sharps containers. The division will report any noncompliance with the sharps containers requirement to the Office of Health Facilities Certification and Licensure.
W. Va. Code R. § 64-82-11 Confidentiality; Disclosure
11.1. No person who obtains information under W. Va. Code '16-36-1 et seq. and this rule may disclose information to any other person except for the fulfillment of purposes consistent with W. Va. Code '16-36-1 et seq. and this rule.
11.2. Any person who obtains information protected by the provisions of W. Va. Code '16-36-1 et seq. and this rule shall sign a statement that he or she fully understands and will maintain the confidentiality of the information.
11.3. The reports of all needlestick injuries submitted in compliance with this rule are protected and are exempt from public disclosure under the exemption for medical records contained in W. Va. Code '29B-1-1 et seq., the Freedom of Information Act: Provided, That the reports are subject to the provisions of W. Va. Code '16-3C-1 et seq. This information shall not be used except as is necessary to enforce State public health laws and rules and to analyze the magnitude of needlestick injuries in the State for assisting in the development of adequate safeguards against their occurrence.
W. Va. Code R. § 64-82-12 Distribution of Rule
The division and health care professional licensing boards and agencies may distribute this rule to any facility that has a duty under this rule.
W. Va. Code R. § 64-82-13 Violations and Sanctions
13.1. Facilities shall comply with the requirements of the standards adopted under W. Va. Code '16-1-18 and this rule as a condition for licensure, certification, and permission to operate.
13.2. The director may revoke or suspend a facility=s licence, certificate, or permission to operate when the facility fails to comply with this rule and all applicable provisions in W. Va. Code '16-36-1.
W. Va. Code R. § 64-82-14 Administrative Due Process
Those person adversely affected by the enforcement of this rule desiring a contested case hearing to determine any rights, duties, interests, or privileges shall do so in a manner prescribed in the division of health Rules of Procedure for Contested Case Hearings and Declaratory Rulings, 64 CSR 1.
64CSR82
Series 83 Birth Score Program
W. Va. Code R. § 64-83-1 General
1.1 Scope. -- This rule establishes the Birth Score Program to identify newborn infants at risk for postneonatal mortality, debilitating conditions and developmental delays. This rule should be read in conjunction with W. Va. Code '16-22B-1 et seq. The W. Va. Code is available in public libraries and on the Legislature=s web page, http://www.legis.state.wv.us/.
1.2. Authority. -- W. Va. Code ''16-22B-4 and 16-1-4.
1.3. Filing Date. -- April 17, 2002.
1.4. Effective Date. -- July 1, 2002.
W. Va. Code R. § 64-83-2 Application and Enforcement
2.1. Application. B This rule applies to any newborn infant born in West Virginia, to the health care provider attending the newborn infant at birth, birthing hospitals and facilities, the West Virginia University Birth Score Office, and primary care providers.
2.2. Enforcement. B This rule is enforced by the Commissioner of the Bureau for Public Health.
W. Va. Code R. § 64-83-3 Definitions
3.1. Birth Score Program. B A system established by the Bureau for Public Health and administered by the West Virginia University Department of Pediatrics for assessing newborn infants shortly after birth.
3.2. Birth Score Developmental Risk Screen. - A medical assessment conducted immediately after birth to identify newborn infants at greatest risk within the first year of life for postneonatal mortality, debilitating conditions, and developmental delays.
3.3. Commissioner. B The Commissioner of the Bureau for Public Health or his or her lawful designee.
3.4. Early Discharge. - Birth admissions lasting twenty-four (24) hours or less.
3.5. Health Care Facility. - Any licensed medical facility that offers birthing services.
3.6. Health Care Provider. B A physician or licensed midwife present during or immediately after delivery of the newborn infant.
3.7. High Birth Score. - A total birth score indicating a newborn infant to be at high risk for post- neonatal mortality, debilitating conditions or developmental delays.
3.8. Low Birth Score. - A total birth score indicting a newborn infant to be at low risk for post- neonatal mortality, debilitating conditions or developmental delays.
3.9. Primary Care Provider (PCP). - A physician, physician=s assistant, nurse, nurse practitioner or other licensed medical professional responsible for the infant=s health services after discharge from the health care facility.
3.10. Total Birth Score. - The sum of the numerical scores of the criteria on the Birth Score Developmental Risk Screen.
3.11. Well Child Visits. - A comprehensive preventive evaluation of an infant=s health status to assure the child is meeting physical and developmental milestones according to current national American Academy of Pediatrics standards.
W. Va. Code R. § 64-83-4 Purpose and Goals
4.1. The Birth Score Program shall identify newborn infants at greatest risk for:
4.1.a. Death between one (1) month and one (1) year of age;
4.1.b. Debilitating conditions; and
4.1.c. Developmental delays.
4.2. The Birth Score Program shall link newborn infants identified as high risk with primary care providers and available medical and social services.
W. Va. Code R. § 64-83-5 Protocol, Reporting and Referral
5.1. The health care provider shall, except when the parent or guardian objects on grounds of religious belief, determine the total birth score on every newborn shortly after delivery when the birth occurs in a hospital or other licensed health facility. If the birth occurs at a nonlicensed facility, the infant=s primary physician shall determine the birth score within ten (10) days after birth.
5.2. The health care provider or the infant=s primary physician shall record or cause to be recorded in the newborn infant=s medical record and on the Birth Score Developmental Risk Screen, the newborn infant=s total birth score.
5.3. When a health care provider or the infant=s primary physician determines a total birth score on an infant, they shall:
5.3.a. Inform the parents or guardians of the birth score findings upon completion of the scoring; and
5.3.b. Provide the parents or guardian with a copy of the Birth Score Developmental Risk Screen.
5.4. When a health care provider determines a high birth score on a newborn infant, the health care provider shall link with the infant=s established local primary care provider for recommended schedule of well child visits at two (2), four (4), eight (8), twelve (12), sixteen (16) and twenty-four (24) weeks of age.
5.5. When the newborn infant does not have a primary care provider, the health care facility shall refer the infant=s parent or guardian to a list of local primary care providers who perform well child visits.
5.6. The health care provider or primary physician shall send a written copy of the screening results within ten (10) days of the newborn=s birth date to the Birth Score Office, West Virginia University Department of Pediatrics, P.O. Box 9214, Morgantown, WV 26506-9214.
5.7. The Birth Score Office shall collect developmental risk /newborn hearing screening data and make referrals to educational, medical, and social support services.
W. Va. Code R. § 64-83-6 Program Monitoring
6.1. The Bureau for Public Health shall:
6.1.a. For each health care facility, keep on file at the Office of Maternal, Child and Family Health a written copy of the procedures that apply to the Birth Score, the Developmental Risk and the Newborn Hearing Screening programs, and the policies regarding early discharge; and
6.1.b. Monitor compliance with the Birth Score Program, taking into account early discharge trends, and shall take corrective action in accordance with the policies and procedures already established in the health care facilities.
W. Va. Code R. § 64-83-7 Confidentiality
7.1. Any person who obtains confidential information while implementing W. Va. Code '16-22B-1 et seq. and this rule may disclose it only to reporting sources, persons demonstrating a need essential to health related research or care of the newborn infant, or as required by law.
7.2. Any person who obtains confidential information while implementing W. Va. Code '16-22B-1 et seq. and this rule shall provide a written statement of confidentiality stating that he or she fully understands the privacy of the information and shall maintain it.
W. Va. Code R. § 64-83-8 Penalties
8.1. Any person who violates the provisions of W. Va. Code '16-22B-1 et seq. or this rule is subject to the penalties provided in W. Va. Code '16-1-18.
W. Va. Code R. § 64-83-9 Administrative Due Process
9.1. Those persons aggrieved by the enforcement of this rule may make a written request for a contested case hearing in accordance with the Division of Health rule, ARules of Procedure for Contested Case Hearing and Declaratory Rulings,@ 64CSR1.
64CSR83
Series 84 Medical Examiner Requirements for Postmortem Inquiries
W. Va. Code R. § 64-84-1 General
1.1. Scope. -- This rule regulates the conduct of medico-legal investigation into the cause of death; sets procedures for postmortem examination of deceased persons and the examination of substances collected as part of that process, to determine the cause and manner of death; sets forth requirements for the training and certification of county medical examiners and coroners; and allows fees to be assessed for services provided to certain private parties by the Office of the Chief Medical Examiner (OCME). This rule should be read in conjunction with W. Va. Code §61-12-3 et seq., §16-19-1 et seq. and §18B-4-8.
1.2. Authority. -- W. Va. Code §61-12-3(f) and §61-12-16.
1.3. Filing Date. -- March 28, 2024.
1.4. Effective Date. -- March 28, 2024.
1.5. Sunset Provision. -- This rule shall terminate and have no further force or effect on August 1, 2029.
W. Va. Code R. § 64-84-2 Application and Enforcement
2.1. This rule applies to the OCME, county medical examiners (CoME), and county coroners (CoCo).
W. Va. Code R. § 64-84-3 Definitions
3.1. American Board of Medico-legal Death Investigators (ABMDI) -- A professional association that provides training and certification in the field of medico-legal death investigation, provides accreditation to other medico-legal death investigation training programs that meet requirements set by the ABMDI, and establishes professional standards of practice for that discipline.
3.2. Assistant County Medical Examiner (ACoME) -- A physician, registered nurse, paramedic, emergency medical technician, or physician’s assistant, who is medically trained and currently certified or licensed, unrestricted, in the State of West Virginia, who is in good standing, and who is appointed by the Chief Medical Examiner (CME) to provide medico-legal death investigation services under direction and supervision of the CME or designee, in accordance with standards of practice as set forth in this rule and the West Virginia Handbook for Performance of Death Investigation and Certification.
3.3. Certification of Death -- The scientific, investigative, and legal processes used by the CME or Deputy Chief Medical Examiner (DCME) to establish conclusions regarding the cause and manner of certain deaths pursuant to the requirements of W. Va. Code §61-12-3 et seq. and §16-5-1, et seq., in particular but not limited to W. Va. Code §16-5-19, §16-5-20, and §16-5-21 related to Vital Records.
3.4. Chief Administrator -- Office Director of the OCME who manages the day-to-day operations of the OCME and is responsible for everything non-medical that occurs under the umbrella of the OCME.
3.5. Chief Medical Examiner (CME) -- A physician licensed to practice medicine or osteopathic medicine in the State of West Virginia, who is a diplomat of the American Board of Pathology in forensic pathology, or equivalent, and who has experience in forensic medicine. The CME shall be appointed by the Commissioner of the Bureau for Public Health.
3.6. Clinical Specialist -- A practitioner of a medical discipline recognized by the American Boards of Medicine Specialties.
3.7. Commissioner -- The Commissioner of the West Virginia Bureau for Public Health or his or her successor as defined by the W. Va. Code.
3.8. County Coroner (CoCo) -- A person who is in good standing, who is trained and certified in the practice of medico-legal death investigation in a manner pursuant to this rule, who is appointed by a county commission, and works under the direction and supervision of the CME or designee.
3.9. County Medical Examiner (CoME) -- A physician, registered nurse, paramedic, emergency medical technician, or physician’s assistant, who is medically trained and currently certified or licensed, unrestricted, in the State of West Virginia, who is in good standing, who is trained and certified in the practice of medico-legal death investigation in a manner pursuant to this rule, and who is appointed by the CME and works under the direction and supervision of the CME or designee.
3.10. Deputy Chief Medical Examiner (DCME) -- A qualified forensic pathologist appointed by the CME as his or her designee to perform all duties specific to, and required for certification of death, for the State of West Virginia as contemplated by W. Va. Code §61-12-3, et seq. This person may be referred to simply as the CME’s designee or as a DCME.
3.11. Forensic Autopsy -- A postmortem forensic examination of a body that may encompass varying levels of surgical exploration and the study and analysis of the body tissues and fluids, according to W. Va. Code and the rules of the OCME.
3.12. Forensic Postmortem Examination -- Any examination of the human body performed after death that is authorized by W. Va. Code §61-12-10.
3.13. Forensic Specialist -- A practitioner of any forensic science or discipline, employing practices and methodologies recognized by the American Academy of Forensic Sciences or equivalent.
3.14 Medico-legal Death Investigation -- The discipline of obtaining information by investigation into the deaths of persons pursuant to W. Va. Code §61-12-8.
3.15. OCME -- Office of the Chief Medical Examiner.
3.16. Organ Procurement Organization -- Eye bank, organ procurement organization, or tissue bank.
3.17. Prosector -- CME or DCME who conducts the autopsy.
3.18. Qualified Forensic Pathologist -- A physician who holds board certification or board eligibility in forensic pathology or has completed an American Board of Pathology or equivalent fellowship in forensic pathology.
3.19. Secretary -- The Secretary of the Department of Health.
3.20. Unclaimed Decedent -- A deceased person who has been positively identified by a recognized forensic identification method and whose remains are in the custody of the OCME only due to the fact that no legal next of kin willing to accept custody in order to make arrangements for final disposition has been identified by the OCME or any other government entity for a minimum period of 30 days after their identification.
3.21. Unidentified Decedent -- a deceased person or a portion of a deceased person who has not been positively identified by a recognized forensic identification method and whose remains are in the custody of the OCME. The OCME at some point assumed jurisdiction and custody of the unidentified decedent under the authority granted in W. Va. Code §61-12-10(a) and sections 6 and 8 of this rule to perform a medico-legal death investigation.
W. Va. Code R. § 64-84-4 Training, Certification, and Standards of Practice of CoME and CoCo
4.1. A CoME:
4.1.1. Shall be trained and certified in the practice of medico-legal death investigation prior to his or her appointment;
4.1.1.a. In order to qualify a person shall complete and pass a course of medico-legal death investigation training accredited by the ABMDI or equivalent which shall include an examination of competency;
4.1.1.b. Any person who holds a prior CoME appointment which has expired may recertify by successful completion of the examination for certification within one year of the expiration;
4.1.1.c. A person who fails the examination for certification shall complete a second accredited training program that satisfies the requirements of this subdivision before taking the examination again;
4.1.2. Shall be certified in the practice of medico-legal death investigation if he or she passes an examination for certification in the practice of medico-legal death investigation administered by the OCME, or as part of any medico-legal training program accredited by the ABMDI or equivalent;
4.1.3. Shall meet the standards of practice as stipulated in the 2007 Edition of the West Virginia Handbook for Performance of Death Investigation and Certification.
4.1.3.a. Noncompliance with the standards of practice as outlined in the 2007 Edition of the West Virginia Handbook for the Performance of Death Investigation and Certification may result in corrective notice, up to and including the suspension of appointment and discontinuation of service as a CoME in the following manner:
4.1.3.a.1. The first identified occurrence of noncompliance with the standards of practice as outlined in the 2007 Edition of the West Virginia Handbook for the Performance of Death Investigation and Certification shall result in a written corrective notice. Evidence of continued noncompliance with the same or similar performance-related issues shall result in a second written corrective notice;
4.1.3.a.2. If a person receives two written corrective notices within one year, that person shall be subject to suspension of appointment and discontinuation of services as a CoME for a period of time to be determined by the CME.
4.1.3.b. A CoME may appeal the suspension of appointment and discontinuation of services to the Commissioner or his or her designee in writing within five days of the suspension.
4.2. A CoCo:
4.2.1. Shall be trained and certified in the practice of medico-legal death investigation prior to his or her appointment by the county commission.
4.2.2. Shall meet the same requirements as a CoME for training, certification, and standards of practice, as described in subsection 4.1. of this section, and subject to discontinuation of service under certain circumstances at the discretion of the CME.
4.3. The OCME shall offer a training course that meets the requirements in this rule at least once each year and shall assess a reasonable fee, established by the CME, to cover the cost of the training.
4.4. Certification in the practice of medico-legal death investigation provided by the State of West Virginia to CoME, ACoME, and CoCo expires after three years and requires recertification as described in paragraph 4.1.1.b. of this section.
4.5. The OCME shall establish a call-out schedule for CoME, ACoME, and CoCo based on certification, appointment, and demonstration of competency by continued successful adherence to performance guidelines established in the 2007 Edition of the West Virginia Handbook for the Performance for Death Investigation and Certification. A hotline number shall be distributed to all county dispatch centers for the purpose of death reporting.
W. Va. Code R. § 64-84-5 Authority of the CoME, ACoME, and CoCo When Investigating a Death
5.1. Subject to the supervision of the CME, the CoME, ACoME, and CoCo shall perform all duties related to medico-legal investigations of death, and provide findings so that the CME or DCME may determine the cause and manner of death and formulate related conclusions as a result.
5.2. When the CoME, ACoME, or CoCo investigates a death where the circumstances fall under criminal investigation:
5.2.1. The CoME, ACoME, or CoCo shall perform all duties related to medico-legal death investigation under the direction of the CME, or his or her designee, and also subject to the direction of the county prosecutor and the principal investigative agency of the jurisdiction;
5.2.2. When entering a scene of death, the CoME, ACoME, or CoCo shall also be under the direction of any agency responsible for the death scene safety or security including, but not limited to, a police agency or the State Fire Marshal, as described by W. Va. Code; and
5.2.3. If any directions given to the CoME, ACoME, or CoCo under subdivisions 5.2.1. or 5.2.2. of this subsection conflict with the provision in subsection 5.1. of this section, the CoME, ACoME, or CoCo shall immediately notify the CME, or his or her designee.
5.3. When the CoME, ACoME, or CoCo, in the performance of other medical duties attends a patient to provide treatment or resuscitation and the person dies, the CoME, ACoME, or CoCo upon pronouncement of death, is specifically prohibited from performing his or her duties as a CoME, ACoME, or CoCo to assist in establishing cause and manner of death or formulate related conclusions, opinions, or testimony in judicial proceedings, except by specific exception at the discretion of the CME.
W. Va. Code R. § 64-84-6 Death Circumstances That Require Medico-legal Death Investigation
6.1. The CoME, ACoME, and CoCo, under authority and supervision of the OCME, shall investigate the circumstances of a death when:
6.1.1. A person dies without benefit of having a pre-existing patient relationship to a treating physician, also referred to as an “unattended death” in W. Va. Code §61-12-8;
6.1.2. A person who is in apparent good health and dies suddenly when there is no history or other reliable evidence of serious natural disease, or other circumstance, so as to be able to reasonably assume death due to natural causes;
6.1.3. Any death of an inmate in a public institution such as a jail dies while in the institution, or while in police custody, during police intervention, during court-ordered hospitalization, or when the death is believed to be due to, or in association with, failure to receive code mandated public services provided by county, state, or federal social service agencies;
6.1.4. A person dies due to, or in association with, environmental conditions suspected to pose a hazard to public health or safety;
6.1.5. A person dies due to, or in association with, violence, suspected violence, or by any suspected external cause, regardless of the interval between the injury and death; or
6.1.6. A person dies under any suspicious conditions, or in any unusual or unnatural manner.
W. Va. Code R. § 64-84-7 Responsibilities of the CoME, ACoME, and CoCo
7.1. The CoME, ACoME, or CoCo shall be available at all scheduled times to perform the duties and responsibilities outlined in this rule and in accordance with the standards of practice as set forth in the 2007 Edition of the West Virginia Handbook for the Performance of Death Investigation and Certification, pursuant to W. Va. Code §61-12- 7(b) and §61-12-14, except where he or she notifies the OCME otherwise in a timely fashion.
7.2. When a CoME, ACoME, or CoCo is notified that a death has occurred, he or she:
7.2.1. May decline to take charge of the body, after initial investigation of the circumstances of death and consultation with the CME or his or her designee;
7.2.2. May take charge of the body and all personal effects and objects that lie close to the body and may be useful in determining the cause or manner of death after consultation with the CME or his or her designee; and
7.2.3. May go to where the body lies at the time of notification or may authorize removal of the body after consultation with the CME or his or her designee and pursuant to the guidelines established in the 2007 Edition of the West Virginia Handbook for the Performance of Death Investigation and Certification to an appropriate place for pronouncement, viewing, and certification of death.
7.3. When a CoME, ACoME, or CoCo takes charge of a body, he or she shall:
7.3.1. Cause to make secure all personal effects or items associated with the body of the deceased; and
7.3.2. Assume full responsibility for the properly inventoried personal effects and their condition until transfer of the items to: an appropriate investigative agency, an authorized funeral agency, or to another entity as directed by the OCME; and in each instance he or she shall list all transferred items on prescribed OCME forms.
W. Va. Code R. § 64-84-8 Pronouncement, Investigation, and Certification of Deaths
8.1. Pronouncement.
8.1.1. A CoME, ACoME, or CoCo may pronounce death when at least one of the following conditions exists:
8.1.1.a. There is a cessation of resuscitative attempts by medical personnel;
8.1.1.b. Medical personnel elect not to initiate resuscitative efforts;
8.1.1.c. Body changes indicating a prolonged postmortem interval; or
8.1.1.d. The injuries present are incompatible with life.
8.1.2. If the CoME, ACoME, or CoCo is unable to pronounce death due to the absence of conditions set forth in subdivision 8.1.1. of this subsection, he or she shall immediately notify medical rescue personnel.
8.1.3. The CoME, ACoME, or CoCo shall record the date and time of the death pronouncement on a form prescribed by the OCME.
8.2. Investigation.
8.2.1. Upon notification of a death under circumstances as listed in section 6 of this rule, when a body has not been removed from the place of death, the CoME, ACoME, or CoCo shall initiate travel to the place of death within one hour or as soon as possible after notification of the death, when:
8.2.1.a. Natural death cannot be assumed on the basis of initial death investigation findings, as provided by police or rescue personnel at the scene, or by any credible report;
8.2.1.b. The CoME, ACoME, or CoCo considers his or her travel to the death scene for the purpose of performing medico-legal death investigation to be in the public interest; or
8.2.1.c. When requested by the OCME, pursuant to section 11 of this rule.
8.2.2. When there is a criminal investigation of the death, the CoME, ACoME, or CoCo shall obtain authorization from the investigating agency holding jurisdiction, or county prosecutor, before entering the scene of death or before performing any examination of the body while at the scene of death.
8.2.3. When entering a scene of death for the purpose of performing medico-legal death investigation, examining a deceased person at the scene of death, the CoME, ACoME, or CoCo shall:
8.2.3.a. Be accompanied by police or any person representing the investigating agency while at the scene of death, at all times;
8.2.3.b. Examine the body at the scene of death to pronounce death if not already pronounced, identify the deceased, record visible postmortem changes, identify and evaluate circumstances useful to determination of cause, manner, time, and location of a death, request photographic documentation of the scene by law enforcement as deemed appropriate, and document the findings; and
8.2.3.c. Record all details of the examination including the time and date of the examination, the identity and official capacity of the accompanying person present during the examination, and all findings from the examination, on the appropriate form provided by the OCME.
8.2.4. When the CoME, ACoME, or CoCo performs a complete external examination of the body, he or she shall:
8.2.4.a. Conduct an external examination of the body only in a location appropriate to the required confidentiality and dignity to be accorded the decedent, such as a local hospital, funeral home, or other similar facility;
8.2.4.b. Be accompanied by a witness authorized to otherwise be present at the facility, such as a funeral director, a person designated by the funeral director, or hospital staff personnel, at all times when performing the examination; and
8.2.4.c. Record all details of the examination including the date and time of the examination, the identity and official capacity of the witness present during the examination, and all findings from the examination, on the appropriate form provided by the OCME;
8.2.5. When investigating a death under the CME’s jurisdiction, the CoME, ACoME, or CoCo shall establish proof of identity of the deceased person.
8.2.6. The OCME, CoME, ACoME, or CoCo may identify the deceased by:
8.2.6.a. A visual examination of the body by a family member or other person at the scene of death who knew the deceased, provided that facial features are sufficiently preserved to reflect the appearance of the deceased in life;
8.2.6.b. By verbal confirmation of visual identification by a family member or other person at the scene of death who knew the deceased, provided that the decedent’s facial features or other unique identifying characteristics, such as tattoos, piercings, etc., are sufficiently preserved;
8.2.6.c. Comparing the body with a photographic identification such as a driver’s license, provided that facial features are sufficiently preserved to reflect the appearance of the deceased in life. When a driver’s license or other photo identification card has been used to verify identification, it, or a duplicate of it, shall be retained in the permanent case file; or
8.2.6.d. Obtaining the assistance of a law enforcement entity with the capacity to digitally capture and compare fingerprints utilizing a remote device to be employed at the death location or location at which the decedent is being inspected.
8.2.7. If a CoME, ACoME, or CoCo cannot identify the deceased by any means as listed in subdivision 8.2.6. of this subsection he or she shall immediately notify the OCME that the decedent is currently unidentifiable.
8.2.8. The CME or his or her designee holding appointment as DCME, in order to identify a decedent, may utilize:
8.2.8.a. Additional visual identification by persons acquainted with the deceased;
8.2.8.b. Dental x-rays or charts;
8.2.8.c. Comparison of postmortem x-rays with ante-mortem radiology imaging;
8.2.8.d. Tattoos, scars, and other unique physical characteristics;
8.2.8.e. Congenital or acquired malformations or anthropomorphic features;
8.2.8.f. Features documented by medical records;
8.2.8.g. Biologic methods of identification or fingerprints;
8.2.8.h. Photography;
8.2.8.i. Personal effects;
8.2.8.j. Circumstances of inclusion or exclusion; and
8.2.8.k. Serialized prosthetics, implants, or medical devices properly recorded in antemortem medical records by the surgeon or medical provider that implanted the prosthetic or medical device.
8.2.9. The OCME and the CoME, ACoME, or CoCo may obtain and review medical records of a person suspected to be deceased for the purposes of identification of a body; or when review of medical records of a deceased person might help determine the cause or manner of death, or answer any material question during an investigation of a death, the CoME, ACoME, or CoCo shall obtain the medical records under the authority of the CME and shall review them for accurate certification of death.
8.2.9.a. Original medical records may not be incorporated into the medical examiner’s file.
8.2.9.b. Copies of these records may become part of the medical examiner’s file at the discretion of the prosector, and as part of the file, may not be released upon any request or subpoena and shall be maintained in a manner identifying them as non-disclosable except as permitted by W. Va. Code §61-12-3, et seq.
8.2.9.c. Copies of medical records that are obtained under this rule, when not maintained in the final medical examiner file, at the discretion of the OCME prosector, shall be returned to the original institution or destroyed at the time of case closure.
8.2.10. The OCME shall radiologically or photographically document dentition or other potentially distinguishing morphologic characteristics, obtain copies of potentially useful ante-mortem imaging, and medical records when available, and archive the information at the OCME. If identification of the body is established through these records, they shall become part of the OCME case file.
8.2.11. When human remains cannot be positively identified, the OCME shall:
8.2.11.a. Mark them “Unidentified” and, if possible, designate them by any of the following categories that apply: White, Black, Asian, Native American, Adult, Child, Infant, Male, or Female; and assign a unique identifying number to the decedent to be known as a “Doe Number” that is generated by the OCME and properly recorded as a permanent part of the case file.
8.2.11.b. Ensure the timely submission of required and available characteristics of the unidentified body to the appropriate registrar established by National Crime Information Center and other nationally recognized unidentified person’s database(s);
8.2.11.c. Take fingerprints, when possible, and keep them on file;
8.2.11.d. Authorize final disposition of unidentified remains to be embalmed, frozen, interred or otherwise disposed, after completion of the final death certificate, in a manner set forth in the W. Va. Code and the appropriate section(s) of this legislative rule; and
8.2.11.e. The CME or his or her designee is authorized to sign a death certificate bearing the designation “unidentified person” indicating that all applicable methods for establishing identity were attempted by the OCME, were unsuccessful, and without expectation of being able to establish identity of the decedent by any known means in the foreseeable future.
8.3. Certification of Death.
8.3.1. After the CoME, ACoME, or CoCo has identified the deceased person, he or she shall enter the deceased person’s name in the appropriate sections of all prescribed OCME forms.
8.3.2. After a CoME, ACoME, or CoCo has identified a deceased person by visual examination at the scene of death, he or she shall document the identification on a form provided by the OCME, affix a toe tag provided by the OCME or other identification tag securely to the body or an article of clothing worn by the decedent placed within the sealed body bag, and if the identification is from a photographic document, submit the photographic document with the investigative report.
8.3.3. If a CoME, ACoME, or CoCo is unavailable to perform medico-legal death investigation, the OCME shall direct investigating law enforcement or rescue or body transport personnel at the death scene to complete and securely affix an identification tag attesting to the identity of the body, in a manner pursuant to this rule.
W. Va. Code R. § 64-84-9 Obtaining Blood, Body Fluids, and Tissue Material for Examination
9.1. A CoME, ACoME, or CoCo in providing assistance with determining cause and manner of death, and when responsible for examination of a body, shall obtain peripheral blood by percutaneous route and urine and vitreous fluid samples, if available, from the deceased person.
9.2. The CoME, ACoME, or CoCo shall collect other fluid and tissue from the body of the decedent only upon specific instruction from the CME or his or her designee, a DCME:
9.2.1. Shall obtain body fluid samples obtained during hospitalization, and submit them for toxicologic analysis;
9.2.2. Shall document collection of body fluid samples obtained during hospitalization on the appropriate OCME form, and shall ensure that the samples are properly labeled and delivered to the OCME in a timely and secure fashion;
9.2.3. Shall obtain tissue specimens for examination, only when specifically directed to do so by the OCME;
9.2.4. Shall use sample containers provided by the OCME which are properly and clearly marked;
9.2.5. Shall seal the sample containers securely;
9.2.6. Shall complete and attach the appropriate forms provided by the OCME;
9.2.7. Shall deliver the sample containers and the forms to the OCME in person, by mail, or by a bonded carrier or by any courier authorized by the OCME, within 24 hours of specimen collection;
9.2.8. Shall handle all biologic materials or any item possibly soiled with biologic materials in a manner consistent with strict infectious disease precautions;
9.2.9. Shall not withdraw blood or other body tissues or fluids when it is determined that transport of the body to the OCME for further postmortem examination is necessary; and
9.2.10. Shall notify the OCME immediately if unable to withdraw sufficient volume of peripheral blood sample as outlined in the 2007 edition of the West Virginia Handbook for Performance of Death Investigation and Certification.
W. Va. Code R. § 64-84-10 Transport of the Body
10.1. The CoME, ACoME, or CoCo shall obtain telephone authorization from the OCME Forensic Investigations Unit (FIU) to arrange for removal of the body to an appropriate place for complete external examination and subsequent certification of death.
10.2. The CoME, ACoME, or CoCo shall arrange for transport of the deceased from the place of death to a funeral home or local hospital morgue under the provisions of this section, for the purpose of performing further examination of the body, according to the following requirements:
10.2.1. The body shall be transported in a timely manner and under appropriate and reasonable conditions;
10.2.2. The body shall be enclosed in a clean, moisture-impervious body bag;
10.2.3. The identity of the body shall be documented by form provided by the OCME affixed securely to the body and the corresponding case number labeled securely on the body bag;
10.2.4. Transportation of remains shall be by an approved transportation company as outlined in subsection 10.4. of this section, using a funeral or ambulance vehicle, or other conveyance as authorized by the OCME; and
10.2.5. The OCME investigation report and any other records obtained by the CoME, ACoME, or CoCo detailing the findings from the examination at the scene of death shall accompany the body or shall be delivered to the OCME in a secure and timely fashion so as to be available to the prosector prior to performing the autopsy.
10.3. In the event that a security tab must be removed from a sealed body pouch, the CoME, ACoME, CoCo, or any person requesting to remove the security tab shall first contact the OCME for approval to remove the security tab. The appropriate form provided by the OCME shall be used by the individual removing the security tab to document the removal of the original security tab and replacement with a second security tab.
10.4. Transport companies used for the purpose of transporting bodies for the OCME shall have a Decedent Transportation Agreement Contract approved and on file with the Bureau for Public Health Central Finance office. Vendors must meet the terms and conditions set forth in the contract, which include but are not limited to, providing their staff with OSHA and blood-borne pathogen training by a licensed funeral director or the OCME and providing documentation of the training upon OCME request. Any drivers used by the transport company shall have a valid W. Va. Driver’s license with no points on record and no criminal record. The transport company shall be insured and bonded for at least $2,000,000 through a Professional Mortuary Insurance policy.
10.4.1. Transport companies used for the purpose of transporting bodies for the OCME shall:
10.4.1.a. Provide appropriate vehicles for the purposes of transporting human remains;
10.4.1.b. Provide vehicles of adequate size and spacing;
10.4.1.c. Not transport such number of cases which exceed vehicle design capacity;
10.4.1.d. Provide vehicles designed so that human remains are not visible during transport by tinting, curtains, shades, or other means;
10.4.1.e. Provide vehicles that are kept clean and maintained in good working condition;
10.4.1.f. Provide vehicles that have effective interior cooling capacity in all climate conditions;
10.4.1.g. Maintain a valid and current W. Va. business license; and
10.4.1.h. Remain in good standing with Workers’ Unemployment Compensation and all state and local taxes.
W. Va. Code R. § 64-84-11 Circumstances Requiring Immediate Consultation with the OCME
11.1. Immediately following initial notification of a death, the CoME, ACoME, or CoCo shall notify the OCME by telephone prior to performing any medico-legal death investigation.
11.2. Immediate notification is also required when a CoME, ACoME, or CoCo is in receipt, at any point in an investigation, of a request from any investigating agency or other authority that the CoME, ACoME, or CoCo perceives may, in any way, constitute a violation of W. Va. Code §61-12-3 et seq., or any provisions of this rule.
11.3. Immediate notification to the OCME is also required under the following determined death circumstances:
11.3.1. Homicides or deaths reported as suspicious for homicide;
11.3.2. Deaths of children younger than 18 years old, except those due to a car accident or when expected, due to known disease;
11.3.3. Multiple fatality events that cause three or more deaths;
11.3.4. Deaths occurring during incarceration, or associated with police action or intervention;
11.3.5. Fire-related deaths;
11.3.6. Deaths associated with a prolonged postmortem interval involving decomposed or skeletonized bodies;
11.3.7. Where remains are not able to be identified;
11.3.8. Cases that are likely to be declined medico-legal jurisdiction; or
11.3.9. When authorization for cremation requested of a CoME, ACoME, or CoCo, as described further in this rule, shall be refused, pending further investigation.
11.4. When a physician, dentist, podiatrist, or nurse practitioner who also serves in the capacity of CoME, ACoME, or CoCo recognizes that his or her patient’s death falls under medical examiner jurisdiction, he or she may not perform medico-legal investigation into the death but shall immediately notify the OCME of the death.
11.5. When a CoME, ACoME, or CoCo has in his or her capacity as a physician, paramedic, or emergency medical technician attempted resuscitation of a deceased person whose death requires medico-legal investigation, he or she may not perform medico-legal investigation into the death but shall immediately notify the OCME of the death.
W. Va. Code R. § 64-84-12 Documentation of Findings Obtained by Medico-legal Death Investigation by the CoME, ACoME, or CoCo
12.1. The CoME, ACoME, or CoCo who investigates the circumstances of a death shall record findings by using OCME reporting forms.
12.2. In cases of declined medical examiner jurisdiction, the CoME, ACoME, or CoCo shall record findings of initial investigation and the status of declined jurisdiction using OCME forms and submit the original forms to the OCME within seven business days of death notification.
12.3. The CoME, ACoME, or CoCo shall complete all pertinent OCME investigative forms as fully as possible, using currently available information.
12.4. If a death requires examination at the OCME, the CoME, ACoME, or CoCo shall submit a copy of the appropriate investigative reporting form with the case or deliver it to the OCME in a secure and timely fashion, so as to be available prior to the autopsy. If a facsimile of the investigation report is initially submitted to the OCME, the CoME, ACoME, or CoCo shall ensure that the original copy of the investigation report is provided to the OCME within seven business days of the death notification; and
12.5. In exigent or emergency situations where the Electronic Death Reporting System (DAVE) is unavailable for an extended period of time and the death is certified by the CoME, ACoME, or CoCo, he or she shall submit the original copy of the completed investigative report, and the completed W. Va. death certificate, in accordance with W. Va. Code §16-5-1, et seq. or a photocopy of the completed death certificate to the OCME within seven business days of the death. Upon receipt at the OCME of the completed original OCME investigation form and death certificate, and, if applicable, the corresponding toxicology fluid samples, the CoME, ACoME, or CoCo shall be paid a reasonable fee, as established by the CME.
12.6. In all cases, the CoME, ACoME, or CoCo shall retain a copy of the OCME investigation report in files kept for that purpose. Upon receipt of payment, these records shall be destroyed as indicated in subdivision 12.6.1. of this subsection.
12.6.1. All obsolete records or third-party records obtained for the purposes of the medico-legal death investigation shall be destroyed.
12.6.2. All OCME records in custody of the CoME, ACoME, or CoCo shall be maintained in accordance with confidentiality, security, and other conditions and restrictions regarding custody and release in this rule and shall be promptly conveyed to OCME upon their request.
12.6.3. At the expiration of the term of service, termination, or resignation of any CoME, ACoME, or CoCo all records shall be returned to OCME.
12.7. All work product created under this rule shall become part of the OCME case file.
W. Va. Code R. § 64-84-13 Authorization for Cremation by OCME, CoME, ACoME, or CoCo
13.1. All requests to cremate a decedent, where the death was pronounced in West Virginia or the cremation will be physically executed within the state and another state or jurisdiction has not issued an authorization to cremate, must be authorized by the OCME, or by the CoME, ACoME, or CoCo, in the DAVE system except when a decedent has donated his or her body to science as set forth in W. Va. Code §61-12-9(d) and in such instance no request to cremate is required to be requested. Before authorizing the cremation of human remains, the OCME, CoME, ACoME, or CoCo shall:
13.1.1. Review the completed death certificate in the DAVE system or a photocopy or facsimile copy of it provided by the funeral director or crematorium in an exigent or emergency situation;
13.1.2. Ascertain that West Virginia death certificate items as set forth in this subdivision are fully and correctly completed as follows:
13.1.2.a. The OCME, CoME, ACoME, or CoCo shall ensure that the name of the deceased is entered correctly;
13.1.2.b. Items referring to the “date of death,” “time of death,” “date pronounced,” “cause,” and “manner of death” sections are fully completed, and a specific and competent cause of death and appropriate manner of death are listed. Only a medical examiner may determine a manner that is anything other than natural. As such, any death certificate with a manner designated other than natural must be certified by a medical examiner. If certified by any other provider, the death must be immediately referred to the OCME for review;
13.1.2.c. Appropriate referral of the death to the “medical examiner/coroner” has been made in cases whose death circumstances fall under section 6 of this rule, by notation in the “was case referred to the medical examiner/coroner” location on the death certificate; and
13.1.2.d. The portions of the death certificate identifying the title and name of the “certifier,” his or her signature, and the “date signed” are completely and correctly filled out.
13.2. If any death certificate item listed in subdivision 13.1.2. of this section is incomplete, or the cause of death statement is not valid or is incomplete, or the certification is not lawful, the CoME, ACoME, or CoCo shall refuse authorization for cremation; any CoME, ACoME, or CoCo refusing cremation authorization under this rule shall immediately refer the case to the OCME.
13.3. The CoME, ACoME, CoCo, or OCME may examine the remains presented for cremation directly, in a timely fashion, to ascertain that the appearance of the body is consistent with the cause of death as stated by the death certificate or to confirm the identity of the deceased.
13.4. When a CoME, ACoME, CoCo, or the OCME has refused authorization to cremate under this section, it is unlawful for any person to solicit authorization for the cremation from any other CoME or CoCo.
13.5. This section applies only to remains of persons whose deaths have been pronounced within the State of West Virginia or for remains of persons whose deaths have been pronounced in another state and does not have a prior authorization for cremation issued by the state or jurisdiction in which the death occurred.
13.6. The CoME, ACoME, CoCo, or OCME shall receive a reasonable fee, to be established by the Chief Medical Examiner. This fee shall be assessed to the requesting funeral agency or crematory for investigation into the circumstances of any death for the purposes of authorization for cremation, as described in this rule.
13.7. The OCME, CoME, ACoME, or CoCo shall document his or her review of the death certificate and certify that there are no defects or omissions to the death certificate that would require further investigation into the circumstances of death, or further examination of the body, by signed authorization of a form provided by the OCME for this purpose. The original OCME form shall be attached as a part of the death certificate file in the DAVE system, or in the case of an exigent or emergency situation requiring paper processing, a copy of the paper form shall be surrendered to the requesting funeral director or crematory, and the OCME, CoME, ACoME, or CoCo shall keep one copy for his or her records pursuant to subsection 12.6 of this rule. In situations where a paper process is utilized, the CoME, ACoME, or CoCo shall submit a second copy to the OCME.
13.8. The CME or his or her designee may authorize cremation, on behalf of the OCME. Upon authorization, the requesting funeral director or crematory shall pay the OCME the current fee as established for the CoME, ACoME, or CoCo under subsection 13.6. of this section.
W. Va. Code R. § 64-84-14 Death Certificate
14.1. The OCME shall complete and certify the death certificate in the DAVE system for all deaths for which OCME jurisdiction has been established in accordance with W. Va. Code §61-12-10 and this legislative rule. Under exigent or emergency circumstances, a CoME, ACoME, or CoCo may complete and certify a paper death certificate utilizing the Cause and Manner of death determined subject to the supervision of the CME. Such exigent or emergency circumstances shall be approved in advance and with the consultation of the Vital Registration Office. Circumstances where a paper death certificate is authorized and utilized must follow the requirements outlined within this legislative rule according to the following:
14.1.1. Only the CME or his or her designee holding appointment as DCME may rule a cause or manner of death as undetermined; paper death certificates completed in the field under exigent or emergency circumstances do not qualify for an “undetermined” manner of death to be assigned;
14.1.2. Regarding a death investigated by the OCME, only the CME or his or her designee holding appointment as DCME may list as “pending” the cause or manner of death for an otherwise completed death certificate when knowledge of the circumstances of death necessary for accurate death certification is lacking, but reasonably anticipated, either through further testing or investigation. Paper death certificates completed in the field under exigent or emergency circumstances do not qualify for a Pending cause or Pending manner to be assigned;
14.1.3. Completion of a death certificate by listing a specific cause or manner of death, previously listed as pending, by the prosector requires the concurring opinion of the CME or his or her designated reviewing DCME, by review of case findings and circumstances, documented by submission to the Vital Registration Office of an appropriate amendment in the DAVE system, or in exigent or emergency circumstances by submission of a paper OCME death certificate completion form bearing the signatures of both the prosector and reviewing DCME. Upon receiving the information required for accurate death certification, the CME or his or her designee holding appointment as DCME shall complete the appropriate electronic or paper process to finalize a pending death certificate;
14.1.4. The CME, or his or her designee, with the assistance of a CoME, ACoME, or CoCo when needed, shall investigate any death where the corresponding death certificate is improperly filled out, invalid, or completed in any manner which is unauthorized by State or Federal law, and may amend the death certificate in conformity to State and Federal law and this rule by following the appropriate electronic or paper process as outlined herein;
14.1.5. The CME, DCME, or designated forensic pathologist holding appointment as DCME shall make all amendments and corrections to already signed and filed death certificates using the appropriate electronic or paper process, approved by the State Registrar, provided for that purpose;
14.1.6. The CME or DCME may amend any section of the death certificate that pertains to the cause, manner, date, or time of death of any previously certified death, when the OCME has made an investigation into the death, as required under W. Va. Code §61-12-8 or under this rule, when the amendment will correct an inaccuracy, except where proscribed by W. Va. Code and this rule by following the appropriate electronic or paper process; and
14.1.7. No human remains which have been subject to a forensic postmortem examination pursuant to W. Va. Code §61-12-8 and §61-12-10 shall be considered to be released from legal control of the medical examiner without a death certificate that is signed and completed in the DAVE system by the CME or his or her designee, or in an exigent or emergency circumstance by the CME or his or her designee, CoME, ACoME, or CoCo on a paper death certificate.
14.1.8. The prosector will complete his or her portion of the death certificate and submit the document to the authorized licensed funeral director through the DAVE system or on paper in exigent or emergency situations. The State Registrar of Vital Statistics is the custodian of the official death certificate. All other references to the completion of the death certificate made in this rule apply to the prosector, CoME, ACoME, or CoCo portion of the death certificate only.
W. Va. Code R. § 64-84-15 Completion of Death Certificates by the CoME, ACoME, and CoCo
15.1. When the CoME, ACoME, or CoCo completes the paper death certificate in exigent or emergency situations, it means that an investigation into the circumstances of the death and, when applicable, performance of a complete external examination of the body have been performed, and that the CoME, ACoME, or CoCo:
15.1.1. Has established the identity of the deceased;
15.1.2. Has reasonably identified the place of death, and place of injury, if applicable;
15.1.3. Has consulted the CME or his or her designee and received directions regarding how to list the cause and manner of death on the associated paper death certificate; and
15.1.4. Has reasonably established the time and date of death, and the underlying injury subject to the supervision of the CME, if applicable.
W. Va. Code R. § 64-84-16 Performance of the Forensic Autopsy
16.1. The CME or his or her designee holding appointment as DCME, may allow an autopsy to be performed in the case of deaths occurring under circumstances when an examination is considered necessary to:
16.1.1. Establish a cause or manner of death;
16.1.2. Establish or confirm identification of the deceased;
16.1.3. Identify, recover, and preserve forensic evidence;
16.1.4. Obtain required samples for toxicologic, microscopic, or other analysis, for purposes described in this section;
16.1.5. Discover or provide interpretation and correlation of facts and circumstances of the death related to public health or safety;
16.1.6. Provide a report of death investigation, postmortem examination, and toxicology test findings for law enforcement;
16.1.7. Answer any other material questions that might apply to the death, that pertain to the public health or safety; or to any anticipated criminal prosecution;
16.2. A forensic autopsy may include, except as noted in subsection 16.4. of this section:
16.2.1. Examination of the cranial cavity and contents;
16.2.2. Examination of the thoracic and abdominal cavities and their contents; and
16.2.3. Surgical exploration of other parts of the body as considered necessary by the prosector;
16.3. The autopsy shall be conducted in such a way to minimize hazards to the persons performing or attending the autopsy, by ensuring that universal precautions are continuously applied.
16.4. When a forensic autopsy is performed, such examination may be limited to whatever extent described by protocol established by the CME.
16.5. Any DCME may authorize a forensic postmortem examination of the body, subject to direction of the CME.
16.6. The prosecuting attorney of any county in which the death or the event contributing to, or causing death, occurred or the judge of the circuit or any court of record having criminal jurisdiction in the county in which the death or the event contributing to or causing death occurred, may request the performance of a forensic autopsy or other forensic post mortem examination of the body by the OCME. In the case of deaths that result from a suspected criminal act occurring in W. Va., but which are pronounced in another state, all costs accruing from performance of autopsy shall be borne by the requesting county authority or court.
16.7. When any person opposes an autopsy, the CME or his or her designee holding appointment as DCME shall give due consideration to the objections. The final decision as to the performance or extent of a forensic postmortem examination is at the discretion of the CME or his or her designee, subject to W. Va. Code §61-12-3, et seq.
16.8. The CME or his or her designee holding appointment as DCME, may employ or consult any forensic or clinical specialist, subject to the approval of the CME, in order to investigate the cause or circumstances of a death, except when the forensic or clinical specialist:
16.8.1. Has resigned previous membership in the American Academy of Forensic Sciences or equivalent for a pending disciplinary matter;
16.8.2. Has applied to the American Academy of Forensic Sciences or equivalent for provisional membership and has been denied; or
16.8.3. Has had a previous membership revoked by disciplinary action by the American Academy of Forensic Sciences or equivalent; or
16.8.4. Has had his or her professional license restricted or revoked by any licensing Board.
16.9. Any information discovered in subdivisions 16.8.1., 16.8.2., or 16.8.3. of this section shall become part of the OCME case file, releasable under W. Va. Code §61-12-10(b), §61-12-10(c), §61-12-10(d), §61-12-10(e), and §61-12-10(g).
16.10. The prosector, in the course of performing autopsies, shall complete and sign all autopsy reports pursuant to OCME policy, with the CME having the authority to sign for the prosector in absentia when necessary.
W. Va. Code R. § 64-84-17 Specimens Collected and Tested
17.1. The CME or his or her designee holding appointment as DCME:
17.1.1. May collect any biologic materials from deceased persons and hold them for the performance of toxicologic or other analyses to determine any fact or circumstance relevant to a medico-legal death investigation, conforming to restrictions named in W. Va. Code §61-12-10(f) and this rule;
17.1.2. Has final authority for disposition of the tissues and fluids except when the materials constitute a predominant amount of the collected deceased remains, in which case the materials shall be considered to constitute the human body, subject to release to the next of kin, administrator or executor of the estate where one exists, or to their designee, as described further in separate provisions of this rule; and
17.1.3. Shall authorize testing of blood and other appropriate specimens collected for both alcohol and drugs by drug screening, in conformity with Forensic Toxicology Laboratory Guidelines, promulgated by the American Academy of Forensic Sciences or equivalent, and pursuant to W. Va. Code §61-12-10 and §17C-5B-1.
17.2 Compliance with toxicologic testing to Forensic Toxicology Laboratory Guidelines, promulgated by the American Academy of Forensic Sciences, 2006, is the responsibility of the Chief Toxicologist, under direction of the CME. The OCME:
17.2.1. May collect and hold for study any non-biologic materials or personal items taken from a body during a postmortem examination to answer any question of forensic significance. The CME or his or her designee shall notify in writing the next of kin, administrator or executor of the estate of the deceased, or their designee, if items were taken, in advance of any anticipated release of custody by the OCME of personal property retained. The next of kin, administrator or executor of the estate of the deceased, or their designee, must contact the OCME in writing within 30 days of receipt of notice to inform the OCME of their intent to receive the personal property, or the property may be disposed of at the discretion of the OCME;
17.2.2. Shall collect and deliver any material or personal items possessing, or thought to possess, forensic significance to the law enforcement agency of jurisdiction, recording the transfer on specific forms designated by the OCME;
17.2.3. May perform, or cause to have performed, any ancillary test or procedure including, but not limited to, X-ray or photographic imaging, obtaining fingerprints, anthropological studies, neuropathological studies, forensic odontology review, or DNA analysis when the procedure or test may render findings of forensic significance; and
17.2.4. May consult, query, or otherwise employ any forensic specialist in order to provide ancillary testing, or other forensic expertise considered necessary for determination, interpretation, or correlation of any fact or circumstance of death thought to have forensic significance, except where the forensic specialist:
17.2.4.a. Has resigned previous membership in the American Academy of Forensic Sciences or equivalent for a pending disciplinary matter;
17.2.4.b. Has applied to the American Academy of Forensic Sciences or equivalent for provisional membership and has been denied;
17.2.4.c. Has had a previous membership revoked by disciplinary action by the American Academy of Forensic Sciences or equivalent; or
17.2.4.d. Has had his or her professional license restricted or revoked by any licensing Board.
W. Va. Code R. § 64-84-18 Release of Information
18.1. Autopsy and investigation findings, results of ancillary studies performed by or at the request of the OCME, and all case file documents created by the process of death investigation by this office are confidential records and information, disclosed only as specified under W. Va. Code §61-12-8, §61-12-10, §61-12-13, and §61-12A-3. The OCME does not create nor release any preliminary reports. Release of information may only be accomplished upon closure of the case. In the case of deaths investigated by the OCME, medical, corrective, other therapeutic, investigative, and incarceration records of the deceased obtained at OCME’s request pursuant to W. Va. Code §61-12-8(a), are confidential and are not releasable by the medical examiner upon any request or subpoena.
18.2. With the exception of any medical, corrective, or other therapeutic, investigative, and incarceration records of the deceased obtained by the investigation at OCME’s request pursuant to W.Va. Code §61-12-8(a) the OCME shall release records and information obtained by the OCME investigation to the next of kin, the executor or administrator of the estate, or to any designee specified by the next of kin or executor or administrator of the estate, upon their written request, except when the circumstances of death are the subject of a criminal investigation or criminal proceeding, in which case the same records and information pertaining to the investigation into the death by the OCME shall be released only to the principal investigating agency, the prosecuting attorney holding jurisdiction for the death, or to their designee unless the release is authorized by order of the court of record having criminal jurisdiction.
18.3. At the direction of the Commissioner, the CME may release autopsy or toxicology reports to governmental agencies when the CME or OCME Chief Administrator finds it to be in the public interest, except when the circumstances of death are the subject of a criminal investigation or criminal proceeding in accordance with W. Va. Code §61-12-10(d).
18.4. The Chief Administrator of the OCME is the designated records custodian of the OCME, and as such, has the responsibility for the review, approval and fulfillment, or denial of requests for release of information. These responsibilities are carried out in consultation with bureau, department, and state level legal counsel whenever necessary.
W. Va. Code R. § 64-84-19 Autopsy Reports
19.1. The autopsy report shall comprise the document titled “Report of Death Investigation and Post-mortem Examination Findings,” together with all reports of ancillary tests requested by the prosector. The autopsy report shall include at least the following items:
19.1.1. The name of the deceased and the method of identification;
19.1.2. The condition of the body as received, including the state of preservation of the body and the development of postmortem changes; the deceased’s clothing as well as its condition and significant defects;
19.1.3. Body development, and the height and weight of the deceased;
19.1.4. A description of body surface features, such as scars and tattoos;
19.1.5. A description of medical treatment and any postmortem organ or tissue donation, and associated effects;
19.1.6. A report of injury and manifestations thereof;
19.1.7. A report of findings on internal examination (if performed), including organ weight, if possible, and appearance, and any abnormalities present, including natural disease, malformation or injury, and their effects;
19.1.8. A report of the microscopic examination, if performed;
19.1.9. A list of retained materials taken from the body during autopsy;
19.1.10. A list of other ancillary studies performed during, or as part of the autopsy, such as toxicology; photography, including, but not limited to photography of identifying features or significant injuries; or X-ray imaging, and their results;
19.1.11. A statement of determination of the cause and manner of death based on autopsy findings, review of pertinent medical and investigative records, and investigation findings, noting both areas of correlation and conflict of autopsy findings with reported circumstances of death; and
19.1.12. The date, place, and time of the autopsy; the identity of the prosector; his or her signature, and the date he or she signed it.
19.2. The autopsy report shall not include copies of any medical, corrective, or other therapeutic, investigative and incarceration records of the deceased obtained by the investigation at OCME request pursuant to W. Va. Code §61-12-8(a).
19.3. The original autopsy report, or any other original or irreplaceable element as determined by the CME pertaining to the OCME case files, may not be released from the OCME custody. When, upon request, copies of autopsy reports are released, pursuant to W. Va. Code §61-12-10, to the prosecuting attorney or to the court of record having criminal jurisdiction over the death, by mail or by other established courier, including electronically, such copies of the autopsy report shall be released with a notarized statement attesting that it is a true and accurate copy of the original record.
19.4. Pursuant to W. Va. Code §61-12-10(e) and §49-2-803, in the case of the death of any unemancipated person under the age of 18, whose death cannot be wholly attributed to natural disease, or where there is suspicion of significant neglect or maltreatment of the decedent, immediate notification of the death and known death circumstances shall be made to Child Protective Services (CPS) of the county of decedent residence, using a form provided by the OCME.
19.5. A reasonable fee may be charged by the OCME for providing autopsy reports.
19.5.1. Fees payable under this section shall be deposited in the health services fund to be used to support the purposes of the OCME.
W. Va. Code R. § 64-84-20 Human Remains and Personal Property
20.1. The OCME shall release human remains from medical examiner custody to a licensed funeral home or as otherwise permitted by law when designated by the next of kin or administrator or executor of the estate only when accompanied by a working copy of the death certificate that is completed and certified by the prosector or delegate in the DAVE system, or in exigent or emergency situations a paper death certificate certified by the OCME, CoME, ACoME, or CoCo.
20.2. The licensed funeral home shall provide written authorization to receive the remains of the deceased by signing a form provided by the OCME.
20.3. The OCME may release custody of remains to an organ procurement organization or its designee only upon receipt of verbal or written authorization by the organ procurement organization or a copy of the prior written authorization for such release provided by the decedent, or by the next of kin, or the executor or administrator of the estate if there be an estate that the decedent or legal next of kin has approved or authorized organ/tissue/cornea recovery. The OCME shall authorize the presence of assigned representatives of an organ procurement organization approved by the OCME to be present to perform duties in the facility including accessing electronic medical records necessary to identify and evaluate potential donor eligibility, as well as obtain authorization in order to facilitate the efficient and economical recovery of anatomical gifts for donation. This authorization and release of custody of the body to the organ procurement organization by the OCME does not constitute a release of medical examiner case jurisdiction by the OCME. The organ procurement organization which accepts custody of a decedent’s remains whose death falls under OCME jurisdiction assumes all responsibility and accrued liability for any change in the condition of those remains while in their possession.
20.4. When the OCME has taken charge of a body, all personal property belonging to and associated with the body:
20.4.1. May be taken into the custody of the OCME;
20.4.2. Shall be described and listed on forms prescribed by the OCME for that purpose; and
20.4.3. Shall be released to the principal investigating agency, upon its request, or in the absence of such a request, when the personal property has no forensic significance, it may be released to the executor or administrator of the deceased’s estate or to the next of kin, or their designee by release to the funeral home/crematorium/transport agency authorized by the next of kin to accept custody of the decedent upon release of custody from the OCME. The OCME shall document the release of the personal property on forms provided by the OCME.
20.5. Upon the OCME transfer of the remains and personal property of the decedent, the transferee assumes full responsibility for decedent remains and personal property.
20.6. In the absence of an identified next of kin, executor or administrator of decedent’s estate, or when the remains or personal property are determined to have further forensic significance, the remains may not be released from the custody of the OCME without authorization by the CME or his or her designee.
20.7. Whenever human remains are received into, or released from, the custody of the OCME, they shall be enclosed in a clean, moisture impervious body bag, with the deceased’s name and the OCME case number clearly labeled on both a body tag reliably affixed to the body and on the body bag.
W. Va. Code R. § 64-84-21 Release of Biological Materials from OCME Custody
21.1. The OCME shall release biological materials, including tissues and body fluids, only to a certified and accredited laboratory upon a written request that is accompanied by a signed authorization from:
21.1.1. The next of kin, the executor or administrator of the estate, or any designee specified by the next of kin or executor or administrator of the estate;
21.1.2. The county health officer, public health laboratory, or the Commissioner/State Health Officer;
21.1.3. Parties in litigation before a court of record to whom the cause of death is a material issue; or
21.1.4. Court order from a court of competent jurisdiction in a civil or family law matter.
21.2. The OCME shall refer requests for testing of biological materials taken at the time of postmortem examination on behalf of persons who may have had an infectious disease exposure as a result of contact with a body under the OCME’s custody, to his or her county health officer, who may request release of a sample.
21.3. When the OCME is notified by a county health officer that a significant infectious disease exposure has occurred as the result of contact with a body under the OCME’s custody, the OCME shall transfer a sufficient sample of blood or other useful biologic material pertaining to the case to the State public health laboratory for appropriate testing. The State public health laboratory is responsible for release of all test results pursuant to applicable State law.
21.4. Before the OCME can comply with a request under subsection 21.1. of this section to release biological materials to a requesting party from a case that is part of a criminal investigation or criminal proceeding, the OCME shall require an order of the court of record having criminal jurisdiction.
21.5. When the CME determines that a biological or other material sample from a case that is part of a criminal investigation or criminal proceeding has irreplaceable forensic value, the OCME may withhold it from an otherwise lawful request for release under this rule unless:
21.5.1. Requested by the prosecuting attorney holding jurisdiction; or
21.5.2. A court of record orders the OCME to release the samples.
21.6. The person or agency requesting biological material release and analysis shall prepay all costs associated with shipping, subsequent analysis, and return of the samples to the OCME, prior to release of the materials.
21.7. The OCME shall only allow shipment of the biological materials directly to the recipient laboratory by courier or other bonded service acceptable to the OCME. Upon the OCME transfer of any biologic materials sample under this rule, the transferee assumes full responsibility for maintaining the forensic integrity and initial conditions of such materials, and for any risks associated with shipping and subsequent analysis.
21.8. The OCME shall handle requests for release of microscopic slides according to the following provisions:
21.8.1. Original slides shall be maintained in the custody of the OCME. Copies of slides will be sent only to a licensed physician or laboratory only after all requirements outlined herein have been satisfied and the case has been closed by the prosector;
21.8.2. When the OCME provides slides by any request, all slides shall be returned to the OCME after examination. Upon the OCME transfer of histology slides under this rule, the transferee assumes full responsibility for maintaining the forensic integrity of such materials, and for return of all materials in original condition and in a timely manner.
21.8.3. When the OCME provides duplicate histologic slides cut from original tissue blocks, the OCME may charge a reasonable fee per slide, to the requesting person or entity, to be deposited in the health services fund to be used to support the purposes of the OCME.
21.8.4. The release to an appropriate entity as described in this rule shall be made upon written request by the next of kin or executor or administrator of the estate, or by their designee.
21.8.5. If a West Virginia court of jurisdiction directs the OCME to release specimens to a party, that party is responsible for all costs incurred by release and transmittal of named materials to that party; and
21.8.6. At the request of an officer of the court engaged in a civil legal matter, except where there is also an ongoing criminal litigation or investigation related to the case associated with the glass slides, the criminal process holds precedence over the civil matter. In that case, authorization for release of the slides must be received from a court of jurisdiction.
21.9. Before the OCME releases histologic samples pertaining to a criminal investigation or proceeding, the request must come from either the prosecuting attorney or other parties in the same criminal court proceeding with a court order.
21.10. When the CME determines that a histologic sample possesses irreplaceable forensic value and is not able to be duplicated, the OCME may withhold it from an otherwise lawful request for release under this rule unless:
21.10.1. Requested by the prosecuting attorney holding jurisdiction; or
21.10.2. A court of record orders the OCME to release the samples.
21.11. All costs and fees associated with the duplication of histologic material, slide preparation, and shipment, including via bonded courier, first class mail, or other delivery service, when chargeable under this rule, shall be paid by the requesting party.
W. Va. Code R. § 64-84-22 Retention of Biological Samples
22.1. The OCME shall retain and archive:
22.1.1. Solid tissue and body fluid samples taken at autopsy for at least one year, and then may retain them or dispose of them at the OCME’s discretion, except:
22.1.1.a. All solid tissue and body fluid specimens associated with homicide cases shall be retained for at least five years, after which the OCME may appropriately dispose of the specimens, except when retention is requested by the court of jurisdiction; and
22.1.1.b. Specimens may be archived for specified additional periods of time by request of the CME or DCME;
22.1.2. Histologic tissue blocks for at least 10 years, and then may retain them or dispose of them at the OCME’s discretion;
22.1.3. Histologic tissue mounted on glass slides for at least 25 years, and then may retain or dispose of them at the OCME’s discretion; and
22.1.4. Dried blood sample cards for at least 50 years, and then may retain them or dispose of them at the OCME’s discretion.
W. Va. Code R. § 64-84-23 Maintenance of Case Files
23.1. The OCME shall maintain complete and thorough files for all cases which it investigates for a period of at least 50 years.
23.2. The OCME shall retain direct custody and control of all original case files contents, shall maintain them in an orderly, secure, and systematic fashion at all times, except when the original records are requested by subpoena for delivery to a court of law for evidentiary purposes. When such original documents are required, the CME or designee shall hand-deliver those documents to the court for inspection along with appropriately attested copies. The original documents shall be returned to the OCME by the CME or designee while leaving the copies for inclusion for evidentiary purposes.
23.3. The OCME shall utilize numbered standard forms, approved by the CME and bearing the dates of any subsequent revision.
23.4. The case files of the OCME shall be considered confidential medical records. The OCME shall release information obtained from the investigation, autopsy, or other examination of the body, or from any ancillary test or procedure performed by, or at the request of the OCME, in accordance with the provisions of subsection 18.1 of this rule.
23.5. The OCME shall maintain autopsy case files for at least 50 years, except when autopsy reports, reports of ancillary studies results, and photographic evidence are archived electronically, in which case the original materials may be destroyed. All obsolete or discarded records shall be destroyed. Any medical or other therapeutic record contained within OCME case files, that were obtained from another agency or institution or other source, pursuant to W. Va. Code §61-12-8(a) may, at the discretion of the CME or DCME, be destroyed at case closure.
23.6. The OCME shall maintain X-rays obtained at an autopsy or copies of X-rays obtained by records request, for at least 10 years, at the OCME’s discretion, or the images may be archived electronically to become part of the case file.
W. Va. Code R. § 64-84-24 Fee Paid to CoME, ACoME, and CoCo by the OCME for Performance of Duties Described By This Rule
24.1. Pursuant to W. Va. Code §61-12-7(b) and §61-12-8(c), and this rule, the OCME shall pay a reasonable fee, established by the CME, and published by the OCME Chief Administrator, to the CoME, ACoME, or CoCo for performance of all duties described by this rule, except as further described in subsection 13.6. of this rule.
W. Va. Code R. § 64-84-25 Fees for OCME Facility Use
25.1. The OCME shall charge a reasonable fee to non-governmental entities approved to use the OCME facility, at the discretion of the CME or OCME Chief Administrator, to cover:
25.1.1. The cost to use the facility; and
25.1.2. The regular rate of pay for the staff supervisor required to be present while the facility is in use or the overtime rate of pay for the staff supervisor required to be present if the facility is in use after the OCME’s usual business hours, as well as additional personnel work time otherwise needed to allow non-OCME facility use.
25.2. Fees payable under this section shall be deposited in the health services fund to be used to support the purposes of the OCME.
W. Va. Code R. § 64-84-26 Charging Certain Fees for Providing Testimony or Production of Opinions
26.1. Under authority of W. Va. Code §16-1-11 and this rule, the OCME shall charge reasonable fees for the provision of testimony or for production of opinions provided by OCME employees, arising from his or her professional OCME-related activities, and for other enumerated services performed by the OCME as follows:
26.1.1. Providing testimony or production of opinions in a civil matter, when neither the State of West Virginia nor any public entity created under the laws of the State of West Virginia, is a party;
26.1.2. Providing testimony or production of opinions for a criminal proceeding arising outside the State of West Virginia;
26.2. The fees charged under subsection 28.1. of this section shall be according to a reasonable fee schedule and agreement, established by the OCME Chief Administrator and approved by the CME.
26.2.1. The fee schedule agreement is attached to this rule as APPENDIX A.
26.3. The fees charged shall be for any OCME employee for time spent in case preparation and for presentation of testimony or any production of opinion, including time spent and expenses incurred in travel and in waiting to provide these services.
26.4. All fees payable under this rule shall be deposited in the health services fund to be used to support the purposes of the OCME.
W. Va. Code R. § 64-84-27 Administrative Due Process
27.1. Those persons adversely affected by the enforcement of this rule may request a contested case hearing in accordance with the Rules and Procedures for Contested Case Hearings and Declaratory Rulings, 64CSR1.
W. Va. Code R. § 64-84-28 Penalties
28.1. The provisions of this rule are subject to enforcement in accordance with W. Va. Code §16-1-17, §16-1-18, and other applicable code sections.
APPENDIX A
STATE OF WEST VIRGINIA
DEPARTMENT OF HEALTH
OFFICE OF THE CHIEF MEDICAL EXAMINER
AGREEMENT FOR PAYMENT OF FEES FOR SERVICES
INVOICE
TO: DATE: RE:
Fees authorized by law; W. Va. Code §16-1-11, Fees for Services, 64CSR51, and Medical Examiner Requirements for Postmortem Inquiries, 64CSR84 ___ Staff/M.D./PH.D. Testimony (or deposition) out of the office: $_____________ Minimum fee of $1,000 (for up to 2 hours), and $500 per each additional hour, or fraction thereof.
Other Staff: $300/hour (64CSR84, §28).* ____ Staff/M.D./Ph.D. Deposition, in office: $500 per hour, or fraction thereof (64CSR84, §28). $_____________ ____ Consultation in office: $400/hour, or fraction thereof (64CSR84, §28).* ____ Use of autopsy suite: $1,000/hour or fraction thereof (64CSR84, §27).* $_____________ ____ Use of OCME Office for deposition: $300/hour or fraction thereof (64CSR84, §27).* $_____________ ____ Cremation Permits: $50 per case (W. Va. Code §61-12-9 and 64CSR84, §13.8).* $_____________ ____ Histology Services: microscopic slide re-cuts: $50 per slide (64CSR84, §21.8.c). $_____________ ____ Copying x-rays: $50/film (64CSR51, §§4.3 & 4.4). $_____________ ____ Photocopying, duplication, etc.: $0.50/page (64CSR51, §§4.3 & 4.4). $_____________ ____ Post-mortem Examination Reports to Family: a report of autopsy or external examination and toxicology report (64CSR84, §19.5) will be sent to authorized family member for a fee of $15, $_____________ upon written request. ____ Post-mortem Examination Reports (Notarized): $300 per case (64CSR84, §19.5) $_____________ (Report of autopsy or external examination and toxicology report) ____ Photograph copying: $2.00 per photograph or $30 per CD (64CSR51, §§4.3 & 4.4). $_____________ ____ Civil Request: Viewing of OCME material: $100/hour, or fraction thereof (64CSR84, §27) $_____________ Autopsy Wet Tissue Specimen and Body Fluid Storage: The OCME stores samples for 1 year $_____________ at no cost. Longer storage beyond 1 year may be requested for a fee of $500 every 3 months, requiring a letter of request (64CSR84, §27); Requestor must submit timely written request and the additional fee payment for each quarter year of additional storage desired or the specimen(s) will be discarded. ____ Medico-legal Investigation Training Course: $$ Varies per course. Registration per attendee based $_____________ on location and associated services required; $50 processing fee for regular registration cancellation; late cancellation (within two weeks of conference) - 50% of registration will be withheld; and for cancellation during or after conference - registration payment is non-refundable.
CRM/05/20/13 Total Due: $_____________ ________________________________________________________________________________________________ Office of the Chief Medical Examiner 619 Virginia Street, W.
Charleston, WV 25302 Phone (304) 558-6920 FAX (304) 558-8492 Authorization:
The Office of the Chief Medical Examiner has established fees for a number of services provided by this Office in accordance with our authority under W. Va. Code §16-1-11 and §61-12-3 et seq. as well as two Bureau for Public Health legislative rules: Medical Examiner Requirements for Postmortem Inquiries, 64CSR84, and Fees for Services, 64CSR51. The service(s) you have requested are subject to these fees.
Payment:
Please do not send cash. Please make check payable to the Office of the Chief Medical Examiner and mail to 619 Virginia Street, W., Charleston, W. VA. 25302. Please record the name of the decedent on your check. Please note that the OCME reserves the right to require expected fee payment prior to performing requested services. Cancellations should be made within 48 hours or the fee will be non-refundable.
Payment must be received before services will be rendered (excluding * services).
Rendered Services:
For services rendered before payment is received the below authorization must be signed:
I hereby agree to pay the Office of the Chief Medical Examiner as invoiced for the abovementioned service. Invoice to be prepared upon completion of services.
Authorized Signature: _____________________________________________________ Title of Person Signing: ___________________________________________________ Date: _________________________________________________________________ _____________ Office of the Chief Medical Examiner 619 Virginia Street, W.
Charleston, W. VA. 25302 Phone (304) 558-6920 FAX (304) 558-8492
Series 86 Surrogates For Incapacitated Persons In Health Care Facilities Operated By The Department Of Health And Human Resources
W. Va. Code R. § 64-86-1 General
1.1. Scope. -- This legislative rule designates individuals and entities who are authorized to act as surrogates for incapacitated persons in the Department’s health care facilities. This rule should be read in conjunction with W. Va. Code §16-30-8 and the definitions in W. Va. Code §16-30-3. The W. Va. Code is available in public libraries and on the Legislature’s web page: http://www.legis.state.wv.us/.
1.2. Authority. -- W. Va. Code §16-30-8(a)(7).
1.3. Filing Date. -- April 4, 2003.
1.4. Effective Date. -- July 1, 2003.
W. Va. Code R. § 64-86-2 Application and Enforcement Section
2.1. Application. -- This rule applies to incapacitated persons who are in need of surrogates and who are patients in the Department’s health care facilities; Department designated surrogates; health care facilities; health care providers; and individuals and entities who are prohibited from serving as surrogates.
2.2. Enforcement. -- This rule is enforced by the Commissioner of the Bureau for Public Health or his or her designee.
W. Va. Code R. § 64-86-3 Definitions
3.1. The definitions in W. Va. Code §16-30-3 apply to this rule.
3.2. Department. -- The West Virginia Department of Health and Human Resources.
W. Va. Code R. § 64-86-4 Designation of Individuals and Entities
4.1. The following are designated as individuals and entities that may be selected in accordance with W. Va. Code §16-30-8(a)(7) as surrogates for patients in the Department’s health care facilities:
4.1.a. Any organization authorized under state or federal laws, or under contract with the Department, to advocate for individuals in the Department’s health care facilities;
4.1.b. Any organization authorized under federal or state laws, or under contract with the Department, to provide surrogacy, guardianship or conservator services for persons in the Department’s health care facilities; and
4.1.c. Any Department employee not otherwise precluded from serving as a surrogate by the provisions of W. Va. Code §16-30-8(i).
64CSR86
64CSR86
Series 89 Uniform Credentialing Of Health Care Practitioners
W. Va. Code R. § 64-89-1 General
1.1. Scope. -- This rule establishes requirements relating to the use of uniform credentialing and recredentialing forms in this State. The W. Va. Code is available in public libraries and on the Legislature’s web page, http://www.legis.state.wv.us/.
1.2. Authority. -- W. Va. Code §§16-1A-2 et seq., 16-1-4 and 33-2-10.
1.3. Filing Date. -- April 22, 2005.
1.4. Effective Date. -- April 22, 2005.
1.5. This is a joint rule of the Department of Health and Human Resources and the West Virginia Insurance Commission.
W. Va. Code R. § 64-89-2 Application
2.1. Except as otherwise provided, this rule applies to all hospitals, insurers, managed care organizations, third party administrators, other health care entities that credential health care practitioners in this state and all health care practitioners designated by the secretary and commissioner.
W. Va. Code R. § 64-89-3 Definitions
3.1. “Commissioner” means the commissioner of insurance.
3.2. “Committee” means the uniform credentialing advisory committee established pursuant to W. Va. Code §16-1A-3.
3.3. “Credentialing” means the process of assessing and validating the qualifications of a health care practitioner, including but not limited to, an evaluation of licensure status, education, training, experience, competence and professional judgment.
3.4. “Health Care Entity” means any of the following that require the submission of credentials data:
3.4.a. A clinic or other health care facility or organization licensed or certified to provide medical or health care services in this state;
3.4.b. A hospital;
3.4.c. A managed care organization;
3.4.d. A third party administrator;
3.4.e. An insurer;
3.4.f. A certified verification organization or any other entity to whom the duties of credentialing or recredentialing have been delegated by another health care entity; and
3.4.g. Any other organization that contracts with health care practitioners for health care services and, in the course of its operations, requires practitioners to provide credentialing information.
3.5. “Health Care Practitioner” means a health care provider who is licensed, certified, or otherwise authorized to provide health care services, as designated by the secretary and commissioner to be subject to the uniform credentialing and recredentialing forms.
3.6. “Recredentialing” means the process by which a hospital, insurer, managed care organization, third party administrator or other health care entity ensures that a health care practitioner who is currently credentialed continues to meet the health care entity’s credentialing criteria.
3.7. “Secretary” means the secretary of the department of health and human resources.
3.8. “Uniform Credentialing Form” means the form developed by the committee to collect the credentials data commonly requested by health care entities for purposes of credentialing.
3.9. “Uniform Recredentialing Form” means the form developed by the committee to collect the credentials data commonly requested by health care entities for purposes of recredentialing.
W. Va. Code R. § 64-89-4 Mandatory Use of Uniform Credentialing Form and Uniform Recredentialing Form
4.1. Beginning July 1, 2003, all health care entities shall use the uniform credentialing form developed by the committee for credentialing health care practitioners and the uniform recredentialing form developed by the committee for recredentialing health care practitioners.
No health care entity may require any health care practitioner credentialed by that health care entity prior to July 1, 2003 to reapply using these forms until the date on which the health care practitioner would otherwise be required to reapply or provide updated credentialing information.
4.2. The health care practitioners who are required to use the uniform credentialing and uniform recredentialing forms are those designated by the secretary and commissioner.
4.3. Once the health care practitioner has completed the uniform credentialing and/or uniform recredentialing forms, he or she may duplicate the forms as necessary for submission to multiple health care entities. The forms shall be accompanied by the following:
4.3.a. An affirmation or attestation page that bears an original signature and date and that verifies the accuracy of the information on the form as of the date it is signed; and
4.3.b. An original signed authorization to release information to the health care entity relating to the professional qualifications, ethical standing, competence, and mental and physical health of the health care practitioner.
4.4. A health care entity may request information in addition to the information provided in the uniform credentialing or uniform recredentialing forms. A request for additional information may not require repetition of the information required in, or substitute another form for, the uniform credentialing or uniform recredentialing forms. Additional information shall be requested by the health care entity on supplemental sheets attached to the uniform forms.
4.5. When the uniform credentialing form or uniform recredentialing form is amended as provided in Section 5 of this rule, all health care entities shall use the amended uniform forms to credential or recredential health care practitioners.
W. Va. Code R. § 64-89-5 Amendment of Uniform Credentialing and Uniform Recredentialing Forms
5.1. The secretary and the commissioner shall reconvene the committee at least annually to review and recommend any necessary amendments to the uniform credentialing form, the uniform recredentialing form or the list of health care practitioners who must use the uniform forms.
5.2. The secretary and the commissioner may, upon recommendation by the committee, jointly propose amendments to the uniform credentialing form, the uniform recredentialing form or the list of health care practitioners.
W. Va. Code R. § 64-89-6 Confidentiality of Credentialing and Recredentialing Data
6.1. Any credentials data collected or obtained by a health care entity during the credentialing or recredentialing process shall constitute confidential peer review information, as provided by W. Va. Code §30-3C-3, and shall not be disclosed by the health care entity except as provided by law.
W. Va. Code R. § 64-89-7 Delegation of Credentialing or Recredentialing Activities
7.1. Nothing in this rule may be construed to prohibit a health care entity from delegating credentialing or recredentialing activities to another entity, such as a certified verification organization, as long as the entity to whom the activities have been delegated follows the requirements of this rule.
W. Va. Code R. § 64-89-8 Violation
8.1. Complaints and allegations of violations of this rule may be filed with either the secretary or the commissioner. If the agency to whom the complaint is addressed determines it to be more appropriate for the other agency to process it, then the secretary or the commissioner may refer it to the other agency for processing.
8.2. Notwithstanding any penalty provisions set forth in W. Va. Code §§16-1-18 or 33-3-11, any health care entity that violates the provisions of this rule is subject to the following:
8.2.a. An award of actual damages established by the health care practitioner, payable to that health care practitioner; and/or
8.2.b. An administrative penalty, payable to the either the Department of Health and Human Resources or the Commissioner, whichever receives the complaint or pursues the action, but not both, in an amount of not less than five hundred (500) dollars and not more than five thousand (5,000) dollars.
64CSR89
64CSR89
Series 89A Forms Applicable To The Uniform Credentialing Of Health Care Practioners
W. Va. Code R. § 64-89A-1 General
1.1. Scope. -- This procedural rule, a joint rule of the Department of Health and Human Resources and the West Virginia Insurance Commission, amends the uniform application forms required to be used for credentialing and recredentialing health care practitioners, and incorporates into this procedural rule those uniform application forms and the list of health care practitioners who must use the forms.
1.2. Authority. -- W. Va. Code §§16-1A-2, 16-1A-3(c), 16-1-4 and 33-2-10.
1.3. Filing Date. -- September 27, 2004.
1.4. Effective Date. -- October 28, 2004.
1.5. This is a joint rule of the Department of Health and Human Resources and the West Virginia Insurance Commission.
W. Va. Code R. § 64-89A-2 Applicability
2.1. Except as otherwise provided, this rule applies to all hospitals, insurers, managed care organizations, third party administrators, or other health care entities that credential health care practitioners in this state and all health care practitioners listed in Appendix C of this rule. This procedural rule shall be read in pari materia with the rule entitled uniform credentialing of health care practitioners (64CSR89, §1, et seq.), which is a joint legislative rule promulgated by the Insurance Commissioner and the Secretary of the Department of Health and Human Resources pursuant to authority granted by the legislature in W. Va. Code §16-1A-2. All of the provisions provided in 64CSR89, §1, et seq., are equally applicable to this procedural rule. W. Va. Code §16-1A-3(c) authorizes the Insurance Commissioner and the Secretary of the Department of Health and Human Resources to amend the uniform application forms and list of health care practitioners who must use the forms by procedural, rather than legislative, rule. This procedural rule amends the uniform forms required to be used for credentialing and recredentialing health care practitioners, and incorporates the uniform forms as well as the list of health care practitioners who must use the forms into this procedural rule. Upon the effective date of this procedural rule, the forms and lists attached to this procedural rule as Appendix A, Appendix B, and Appendix C, will apply to the credentialing and recredentialing of health care practitioners in this state.
Please complete each section thoroughly.
Attach additional sheets where necessary.
(Indicate clearly the practitioner name and section on each attachment)
Type or print clearly in black ink.
Sign and date the application Practitioner’s Name Social Security Number Date of Birth Credentialing Entity Name YOU MUST INCLUDE THE FOLLOWING WITH THIS COMPLETED APPLICATION (Use this checklist as a guide)
Copy of ALL current State License(s): For purposes of this application, State License shall include licensure from all 50 states, the District of Columbia, and U.S. Territories.
Copy of current DEA Registration (if applicable)
Copy of current State Controlled Dangerous Substance (CDS) Certificate (if applicable)
Copy of current professional liability insurance policy face sheet, showing expiration dates, limits, and Practitioner’s name Copy of Board Certification Certificate(s) (if applicable), or other National Certification Certificates Copy of certificate(s) or letter(s) certifying formal post-graduate training Copy of Curriculum Vitae/Resume (Include work history)
(Not accepted as a substitute for completion of application.)
Copy of ECFMG Certificate (if applicable)
Copy of W-9 for verification of each tax identification number used (required for payers only)
Copy of Visa or work permit (if not a U.S. citizen)
Copies of CME/CEU session certificates (if required by Credentialing Entity)
Signature requirements per each entity Professional Peer References (if required by Credentialing Entity)
CREDENTIALING ENTITIES MAY SUPPLEMENT THIS CHECKLIST OF REQUIRED ITEMS AS NEEDED TO MEET CREDENTIALING REQUIREMENTS 12/02; 3/03; 11/03; 1/04; 5/04 Confidential and Privileged Peer Review Pursuant to WV Code 30-3C-1 et.seq* Responses must be legible. Any response, which cannot be completed in the space provided, may be included on supplementary sheets of paper and attached. DO NOT LEAVE ANY FIELDS BLANK. If an item is not applicable, indicate N/A. Please note you will be held responsible for all information or omissions in this application, regardless of whether such statements were prepared by you, an employee, agent or representative. For time gaps greater than three (3) months provide information in Section 11. After completion of the application, you may photocopy and then submit with a signed attestation to each entity to which you wish to apply.
Misrepresentation of any statements and information provided by you in support of this application shall be considered fraudulent and may result in denial or revocation of appointment. (If more space is needed, please supply the information on a separate sheet and attach.)
- Applicant Information Last Name (as shown on state license)
First Name Middle Name Maiden Name Suffix (e.g., Jr., Sr., etc.)
Degree (e.g., MD, DO, DDS, DPM, PA-C, RN)
Gender Birth Date Birthplace Male Female Other Name(s) Also Known By Name(s)
Date Name Used Area(s) of Specialty (please be specific and list any primary focus)
Specialty:
Sub-specialty:
Citzenship Are you a US Citizen?
Please provide the following information if you are not a US Citizen:
If no, what is your citizenship?
If no, what is status of your Visa?
If no, do you hold a permanent work permit?
Type of Visa:
Expiration of Visa:
Social Security # National Provider ID# (if available)
ECFMG# (if applicable, attach copy)
ECFMG Certificate Date Current Home Address Home Telephone Is this # Unlisted?
Home Fax Language(s) Spoken (Other than English)
- Office Practice Information If you have more than one office site or more than one billing address or entity, please make a photocopy of this section before completing it and provide information for each site or billing entity (i.e., multiple tax identifiers), as needed. Indicate below whether the office is the primary or an additional site. (Note: Only one primary site should be designated.)
Primary Office Site #1 Additional Office Site # Group/Practice Name Type of Practice [ ] [ ] [ ] [ ]
Individual Partnership Group Corporation Hospital Based Teaching or Research Other (specify):
Address (Building, Street, Suite #)
County Answering Service/After-Hours Number Alternate Telephone Number Cell Phone Number Beeper/Pager Number E-Mail Address Long Range Beeper Number Medicare Number UPIN Number Medicaid Number Are you currently accepting new patients?
Have you closed your practice to any plans or programs?
By referral only If Yes, please list Handicap Accessible?
Public Transit Available?
Does the office have other services available for disabled?
(TTY, ASI, Mental/physical impairments, etc.)
If yes, list below what services are available Office Manager’s Name Nurse Manager’s Name Credentialing Contact Phone# Office Hours Check if not applicable Check if practitioner is not available to see patient during hours indicated Monday Tuesday Wednesday Thursday Friday Saturday Sunday Services Provided (Please check below if these services are available)
Lab Services On-Site Reference Lab Name:
CLIA Number and Type of Certification:
Radiology Services EKG Sigmoidoscopy Audiology Services Treadmill Other (Please list):
List any special diagnostic or treatment procedures performed in your office:
Patient Population Do you limit the age of patients you treat?
If yes, what ages do you treat?
Minimum:
Maximum:
Remittance/Billing Information (NOTE: Must match box 33 on HCFA/CMS 1500)
Are all services payable to one practice or group name/address?
Group/Practice Name (Check Payable to):
Address (Building, Street, Suite #)
Billing Office Phone Number Billing Manager’s Name Tax ID Number (must watch W-9)
Name affiliated with Tax ID Number (must watch W-9)
Business Interests Do you or your business entity own, operate, have an interest in, or participate in any medical enterprise or business?
If yes, provide details on separate sheet Do you have a financial relationship with a hospital, clinical lab, nursing home, pharmacy, radiology lab, emergency room, or any other medical related organization?
If yes, provide details on separate sheet Practice Classification Primary Care Physician (Family Practioners, Internists, or Pediatricians who deliver primary health care services)
Specialist Physician (Physicians other than primary care physicians in their designated clinical practice)
Allied Health Professional (Licensed, certified, or registered non-physician Practitioners of direct patient care services)
Dual Role (Serve as both a Primary Care Physician as well as a Specialist)
Directory Listing Should this office be listed in the directory?
Should this office receive correspondence?
Please indicate, in preference order, how you wish to be listed in the directory.
Primary Specialty:
Secondary Specialty:
After-Hours Coverage Do you provide 24-hour coverage?
Describe Coverage Do you have an answering service/machine?
Is your answering service/machine available at all times when you are not in the office?
List below other after-hours arrangements or special instructions to patients for after-hours care needs:
Back-up Coverage (Please list the name, specialty, and phone number of partner(s) or associate(s) or physician(s) covering your practice in your absence.)
Name Specialty Partner, Associate, or Covering Phone Number Admitting Service Do you admit patients to the hospital under your own service?
If no, to whom do you admit?
Practitioner Extenders Please check any of the following practitioner extender types and list individual names who you either employ or utilize for direct patient care.
Physician’s Assistant:
Nurse Practitioner:
Nurse Midwife:
Other (specify):
Workers’ Compensation Information Do you accept Workers’ Compensation Patients?
If yes, please provide the following information:
a. Are staff trained in identification and care of patients with work-related illness/injury and provide care/services with an active return to work philosophy?
b. Modified or alternative duty is actively evaluated for each Workers’ Compensation claimant.
c. Office will accommodate urgent walk-ins (or non-urgent appointments within 48 hours) to treat injured or ill workers and facilitate their return to work, if possible.
d. Staff are available and willing to provide compensation representatives information regarding a claimant’s care.
- Medical/Professional Education:
(Attach copy of diploma. If international graduate, submit ECFMG Certificate.) If additional space is needed, please photocopy this page and attach. All time gaps greater than three (3) months must be accounted for in Section 11.
Name of School Degree Received Dates of Attendance (List Mo/Yr)
Phone # (if known)
Graduation Date Name of School Degree Received Dates of Attendance (List Mo/Yr)
Graduation Date 4. Professional Training - Internship/Residency/Fellowship/Preceptorship/Other List all, completed or not. (Attach copies of all program certificates.) All time gaps greater than three (3) months must be accounted for in Section 11.
Training Institution Program Internship Fellowship Other:
Residency Preceptorship Type of Training/Specialty Dates of Training (Mo/Yr)
Was program successfully completed?
If no, explain Your Program Director’s Name Current Program Director’s Name (if known)
Training Institution Program Internship Fellowship Other:
Residency Preceptorship Type of Training/Specialty Dates of Training (Mo/Yr)
Was program successfully completed?
If no, explain Your Program Director’s Name Current Program Director’s Name (if known)
Training Institution Program Internship Fellowship Other:
Residency Preceptorship Type of Training/Specialty Dates of Training (Mo/Yr)
Was program successfully completed?
If no, explain Your Program Director’s Name Current Program Director’s Name (if known)
Training Institution Program Internship Fellowship Other:
Residency Preceptorship Type of Training/Specialty Dates of Training (Mo/Yr)
Was program successfully completed?
If no, explain:
Your Program Director’s Name Current Program Director’s Name (if known)
- State License(s): List all current and past professional licenses (Submit copy of current licenses)
License # Issue Date States (Please check)
Is/was license restricted?
Reason License is/was Inactive or Restricted Does the scope of your practice require the supervision of another practitioner?
If Yes, please list name of each supervising practitioner:
Practitioner Name:
- Certifications/Registrations [ ] .
Check here if entire section is not applicable to applicant Federal DEA Certificate [ ] Not applicable (Submit copy of current DEA Certificate)
Certificate # Unlimited?
If no, explain:
State DEA or CDS Certificate(s) [ ] Not applicable (Submit copy of current State Controlled Dangerous Substance Certificates, if applicable)
Certificate # Unlimited?
If no, explain:
Other Certificate(s)/Formal Training (Please check below if currently certified. Submit copy[s])
Basic Life Support (BLS)
Advanced Cardiac Life Support (ACLS)
Pediatric Advanced Life Support (PALS)
Advanced Trauma Life Support (ATLS)
Neonatal Advanced Life Support (NALS)
Anesthesia Permit Health Care Practitioner (Core C)
Neonatal Resuscitation Program (NRP)
Therapeutics Classification Number (Optometrists only)
Other (please list below or on a separate sheet and include descriptions):
- Specialty Board Certification: Submit copies of board certifications and/or qualification confirmation letter.
Are you board certified?
(If yes, list below)
Certifying Board Name & Specialty Initial Certification Most Recent Recertification Date Next Expiration If not certified, are you qualified to sit for the examination?
If not certified, please indicate your status in the certifying process:
Failed to pass specialty board examination How many times have you taken the exam but failed to pass?
Last date(s) exam was taken:
Date(s) board examination was taken/retaken and date board exam is scheduled, if applicable:
Date(s) taken/retaken Date scheduled, if applicable Not eligible to take specialty boards Not planning to take specialty boards Admissible with exam pending 8. Professional Peer References Please list three (3) professional peer references who have personal knowledge of your current clinical abilities, ethical character, health status, and ability to work cooperatively with others, and who will provide specific written comments on these and other relevant matters upon request. References will be evaluated according to the extent of their direct clinical observation of your work and other knowledge of you. These individuals must have acquired the requisite knowledge through observation of your professional practice over a reasonable period of time. At least one reference must be from the same specialty area, not formerly, currently or about to become associated with you in practice. At least one must be from an individual who has had organizational responsibility in a medical setting (e.g., Department Chair, Medical Director). If your training was completed within the past three (3) years, you may list your Program Director(s) as a professional reference. If you have been out of training for more than three (3) years, it is important to name individuals who are more currently familiar with your professional practice. The individuals should not be related to you by family or financial association.
Reference Name 1 Title Relationship:
(instructor, department chair, chief of staff, colleague, etc.)
Reference Name 2 Title Relationship:
(instructor, department chair, chief of staff, colleague, etc.)
Reference Name 3 Title Relationship:
(instructor, department chair, chief of staff, colleague, etc.)
- Hospital/Health Care Entity Affiliations (list current affiliation first)
List ALL health care facilities at which you currently have, or have had, privileges. Explain gaps greater than three (3) months in Section 11.
Name of current Primary Hospital Affiliation Type of Hospital/Health Care Entity (e.g., Hospital, Nursing Home, etc.)
- Additional Affiliations:
(Photocopy this page for additional affiliations)
- Work History/Experience:
List in chronological order (beginning with current) all current and previous professional work history including Military Service. You must explain gaps greater than three (3) months in Section 11. (If additional space is needed, please photocopy this page and attach.)
JobTitle or Type of Work Performed Phone Number 11. Time Gaps Provide information for all time frames of three (3) months or more that are not covered in Medical/Professional Education, Professional Training, Hospital/Health Care Entity Affiliations, or Work History/Experience sections (such as extended travel, maternity leave, relocation, etc.).
Check here if entire section is not applicable to applicant
Section Dates Explanation Medical/Professional Education Professional Training Hospital/Health Care Entity Affiliations Work History/Experience 12. Continuing Education Requirements A. Have you completed the continuing education hours as required by your State Licensing Board during the past two (2) years OR the required CME/CEU hours (if applicable) from the State licensing board in which you are currently practicing?
B. Attach certificates as noted on Page 1 for the CME/CEU sessions you have completed in last two (2) years (if required by Credentialing Entity).
- Professional Associations/Organizations List the associations/organizations related to your profession in which you are a member. Please include dates of affiliations. Include faculty appointments.
Check here if not applicable 14. Professional Liability Insurance Coverage:
Submit a copy of your current professional liability insurance coverage face sheet showing coverage in your practice specialty. Please list current and previous insurance carriers for the last ten (10) years in chronological order beginning with most current. (If additional space is needed, please photocopy this page and attach.)
Current Insurance Carrier Effective Date Termination Date million/occurrencemillion/aggregate Second Current Insurance Carrier Effective Date Termination Date million/occurrencemillion/aggregate Previous Current Insurance Carrier Effective Date Termination Date million/occurrencemillion/aggregate Previous Current Insurance Carrier Effective Date Termination Date million/occurrencemillion/aggregate 15. Professional Liability Insurance Coverage Disclosure:
If the answer to any of these questions is yes, please provide a full explanation of the details of each and every matter on the attached Professional Liability Information Addendum. The explanation must include the name of the court in which the suit was filed, the caption and docket number of the case, and the name and address of the attorney defending you, and all other relevant details. Include suits in which a judgment or settlement was made against a professional corporation of which you are/were a member, shareholder or employee in any matter in which you were involved in the patient’s care.
A. Has your professional liability insurance coverage every been terminated by action of the insurance company?
B. Have you ever been denied professional liability insurance coverage?
C. Has any (current or previous) professional liability insurance carrier excluded any specific procedures or specific area of practice (e.g., obstetrics, surgery, etc.) from your coverage?
D. During the time of your professional practice, have you had any professional liability claims, suits, settlements, or judgments filed against you or are any currently pending?
E. Have any restrictions ever been placed on your professional liability insurance coverage?
F. Have you ever practiced without professional liability coverage?
G. Are there any incidents for which you have been contacted by an attorney regarding potential professional liability (e.g., settlement requests, writ of summons, etc.)?
Professional Liability Information Addendum (Photocopy this form for each case/action)
Please supply the following and sign and date this form:
Information for each professional liability action you have had taken against you, including those pending.
Information for each settlement, or decision for the plaintiff that has ever occurred on our behalf.
Practitioner Signature and Date All information is held in strict confidence and used for credentialing and recredentialing purposes only. Failure to supply sufficient details may prevent your application from being approved. In addition to completion of this form, practitioner may also submit any additional supporting documentation.
Check here if entire section is not applicable to applicant (and sign below even if no suits or settlements).
Check here if no professional liability actions/claims filed (and sign below even if no suits or settlements).
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Case Number 2. Carrier Name 3. Name of Plaintiff 4. Date of Incident 5. Date Filed 6. Date Closed 7. What was/is your status in the case?
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What is the status of the case?
Primary Defendant Co-Defendant Other, please explain:
Dropped Settled Out of Court Under Appeal Found for Defendant Pending Dismissed Without Payment Found for Plaintiff 9. Amount of Any Settlement or Award?
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Date of any Settlement or Award Please explain the following in detail. (If an item does not apply please check “N/A”)
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What was the alleged harm to the patient?
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What were you alleged to have done incorrectly or failed to do?
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Describe the patient’s illness and related effects of the alleged harm.
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Describe any other details you believe are pertinent to the case.
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Identify any other parties named in the suit.
Practitioner Signature (REQUIRED)
Date (REQUIRED)
- Practice Disclosure Information If the answer to any question below is yes, please provide a full explanation of the details on a separate sheet and attach.
A. Have any investigations been initiated or are any pending against you by any state licensure board, registration board, or regulatory agency?
B. Has your license to practice in any state ever been voluntarily or involuntarily relinquished, restricted, denied, reduced, limited, suspended, placed on probation, revoked, or subject to any disciplinary action including reprimand?
C. Have you ever been suspended, sanctioned, or otherwise restricted from participating or been the subject of an investigation in any private, federal, or state health insurance program (e.g., Medicare, Medicaid)?
D. Has your narcotics (DEA) registration certificate (federal or state) ever been voluntarily or involuntarily relinquished, limited, suspended, not renewed, placed on probation, revoked, or challenged?
E. Have you ever been convicted of or plead no contest to any criminal (felony or misdemeanor) charges including a drug or alcohol-related offense or motor vehicle offenses, but not including minor traffic or parking violations? Are any such proceedings currently pending?
F. Have you ever had an academic appointment denied, limited, revoked, suspended, reduced, placed on probation, not renewed, or other adverse action taken?
G. Have you ever been refused membership on the medical or allied health staff of any hospital or institution or been denied advancement in staff status?
H. Have your employment, medical staff status, appointment, reappointment, or clinical privileges, or scope of practice ever been voluntarily or involuntarily suspended, restricted, reduced, revoked, denied, relinquished, not been renewed or subjected to probationary conditions or limited at any hospital, managed care organization or other health care entity?
I. Have you ever been denied membership or renewal, or been reprimanded, censured, suspended, revoked, placed on probation, or otherwise sanctioned by any health care organization, including but not limited to, hospitals, HMOs, PPOs, IPAs, PHOs, professional associations, or societies, professional standards review organization or peer review organizations, or any other health care facilities, based on professional competence?
J. Have you every withdrawn your application for appointment, reappointment or request for clinical privileges or resigned from the medical or allied health staff of a hospital, managed care organization, or other health care entity while under investigation or before a decision about your appointment or reappointment or clinical privileges was rendered by the governing board of any hospital, managed care organization or any other health care entity?
K. Have you ever been allowed to resign your position or voluntarily relinquish specific clinical privileges rather than face any charge or investigation on the part of the medical staff of a hospital, managed care organization, or other health care entity?
L. Are there currently pending adverse actions on your employment, medical staff appointment, reappointment, clinical privileges or scope of practice at any hospital, managed care organization, or other health care entity?
M. Has any investigation (other than normal performance improvement reviews) involving your clinical practice, competence or professional conduct ever been initiated by any hospital, managed care organization, governmental agency, other health care entity, or branch of the armed forces?
N. Has your request for any specific clinical privileges or scope of practice ever been denied (as a result of disciplinary action) or granted with stated limitations or conditions (aside from ordinary initial probationary requirements of proctorship)? Are such proceedings currently pending?
O. Do you have any knowledge of any civil actions pending against you by any hospital, law enforcement agency, professional group or society?
P. Have you had any charges of unprofessional conduct brought against you?
Q. Have you had any charges of fraud brought against you?
R. Have you received any confirmed Quality Citations from a Peer Review Organization (PRO) in the last two (2) years? If you answered yes, on a separate sheet, indicate the address of the PRO that cited you, the circumstances of the citation and the number of points you were fined.
Health Status Note: Your application will be processed in the usual manner regardless of how you answer questions A and B. If you have answered “No” to question A or B, please explain completely on a separate sheet. If you are found to be qualified, a representative will contact you to determine what accommodations are necessary and feasible to allow you to practice safely.
A. Are you physically and mentally able to perform all the essential functions or services necessary to exercise the privileges or services applied for with or without a reasonable accommodation?
B. Are you able to perform these functions without significant risk of injury to yourself or others?
C. Do you illegally use drugs?
Have you used illegal drugs within the last two years?
D. Do you currently take any medications that may affect your ability to perform the clinical privileges or scope of practice requested competently and safely?
Health Care Entity:
WEST VIRGINIA PRACTITIONER
ATTESTATION/AUTHORIZATION AND RELEASE OF INFORMATION
By submitting this attestation/authorization and release of information form in conjunction with the West Virginia Credentialing Form (WVCF) and/or the West Virginia Practitioner Attestation/Authorization, I understand and agree as follows:
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I understand and acknowledge that, as an applicant for medical staff membership and/or participating status with the Health Care Entity indicated on the WVCF for initial credentialing or recredentialing, I have the burden of producing adequate information for proper evaluation of my competence, character, ethics, mental and physical health status, and/or other qualifications.
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I further understand and acknowledge that the Health Care Entity or designated Agent will investigate the information in this application. By submitting this application, I agree to such investigation and to the disciplinary reporting and information exchange activities of the Health Care Entity as part of the verification and credentialing process.
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I authorize all individuals, institutions, and entities or organizations with which I am currently or have been associated and all professional liability insurers with which I have had or currently have professional liability insurance, who may have information bearing on my professional qualifications, ethical standing, competence, and mental and physical health status to release the aforementioned information to the designated Health Care Entity(ies), their staffs and agents.
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I consent to the inspection of records and documents that may be material to an evaluation of qualifications and my ability to carry out the requested clinical privileges or provide services I request. I authorize each and every individual and organization in custody of such records and documents to permit such inspection and copying. I am willing to make myself available for interviews if required or requested.
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I attest to the accuracy and completeness of the information provided. I understand and agree that any misstatements in or omissions from the WVCF Attestation/Authorization and attachments hereto may constitute cause for denial of the application or summary dismissal or termination of membership/clinical privileges/participation agreement.
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I agree to exhaust all available procedures and remedies as outlined by in the bylaws, rules, regulations, and policies, and/or contractual agreements of the Health Care Entity(ies) where I have membership and/or clinical privileges/participation.
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I understand that completion and submission of the WVCF Attestation/Authorization and Release of Information does not automatically grant me membership or clinical privileges/participating status with the Health Care Entity(ies) indicated on the WVCF or Attestation/Authorization.
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I further acknowledge that I have read and understand the foregoing Attestation/Authorization and Release of Information. A photocopy of this Attestation/Authorization and Release of Information shall be as effective as the original, and authorization constitutes my written authorization and request to communicate any relevant information and to release any and all supportive documentation regarding this application/attestation/authorization.
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I release from liability any and all individuals and organizations who provide information to the credentialing entity in good faith and without malice concerning my professional qualifications and competence, and the credentialing entity, from liability for their acts performed and statements made relating but not limited to verifying, evaluating and acting upon my credentials and qualifications.
Print Name Here:
Signature: Date Note: Through above signature, I hereby affirm that contents are current, accurate and complete as of the signature date.
Modification to the wording or format of the WVCF/Attestation/Authorization and Release of Information may invalidate an application.
Credentialing Entity may supplement additional Attestation/Authorization/Release of Information through an additional release document as required by the entity.
The Entities will treat this application and any information secured in connection therewith in strict confidence in accordance with the Entities’ policies and/or Medical Staff Bylaws and preserve with all reasonable safeguards the privacy of the Applicant.
ADDENDUM
VERIFICATION OF PROFESSIONAL LIABILITY
I, the undersigned, authorize my CURRENT professional liability insurance carrier, (Enter Current Professional Liability Insurance Carrier Name)
(Enter Street Address (City) (State & Zip) to send verification of my professional liability coverage, to include dates of coverage, amounts of coverage, and any limitations in coverage, to is to hereinafter be a Certificate Holder and is to be notified of the amount of my coverage and any future changes in my insurance status, to include all information regarding claims history (but not necessarily limited to judgments entered, claims settled, cases and lawsuits pending), and any restriction regarding specific privileges which may be excluded from coverage.
I will notify of any changes in Professional Liability carriers so that another Verification of Professional Liability form can be completed.
Practitioner’s Signature Date Printed Name (Instructions: Please complete, sign, date and return to entity named above with your initial application.)
Please complete each section thoroughly. Information submitted on the application should be representative of activity/information that occurred or changed on or after the Date of Last Credentialing listed below.
Attach additional sheets where necessary.
(Indicate clearly the practitioner name and section on each attachment)
Type or print clearly in black ink.
Sign and date the application.
Date of Last Credentialing (may be obtained from Entity if not provided)
Practitioner’s Name Social Security Number Date of Birth Credentialing Entity Name YOU MUST INCLUDE THE FOLLOWING WITH THIS COMPLETED APPLICATION (Use this checklist as a guide)
Copy of current State License(s) For purposes of this application, State License shall include licensure from all 50 states, the District of Columbia, and U.S. Territories.
Copy of current DEA Registration (if applicable)
Copy of current State Controlled Dangerous Substance (CDS) Certificate (if applicable)
Copy of current professional liability insurance policy face sheet, showing expiration dates, limits, and practitioner’s name Copy of Board Certification Certificate(s) (if applicable), or other National Certification Certificates (if changed since date of last credentialing)
Copies of CME/CEU session certificates (if required by Credentialing Entity)
Signature requirements per each entity Professional Peer References (if required by Credentialing Entity)
CREDENTIALING ENTITIES MAY SUPPLEMENT THIS CHECKLIST OF REQUIRED ITEMS AS NEEDED TO MEET CREDENTIALING REQUIREMENTS.
Responses must be legible. Any responses, which cannot be completed in the space provided, may be included on supplementary sheets of paper and attached. DO NOT LEAVE ANY FIELDS BLANK. If an item is not applicable, indicate N/A. Please note you will be held responsible for all information or omissions in this application, regardless of whether such statements were prepared by you, an employee, agent or representative. For time gaps greater than three (3) months provide information in Section 11. After completion of the application, you may photocopy and then submit with a signed attestation to each entity to which you wish to apply.
Misrepresentation of any statements and information provided by you in support of this application shall be considered fraudulent and may result in denial or revocation of appointment. (If more space is needed, please supply the information on a separate sheet and attach.)
- Applicant Information (Entire section must be completed)
Last Name (as shown on state license)
First Name Middle Name Maiden Name Suffix (e.g., Jr., Sr., etc.)
Degree (e.g., MD, DO, DDS, DPM, PA-C, RN)
Other Name(s) Also Known By Name(s)
Date Name Used Area(s) of Specialty (please be specific and list any primary focus)
Specialty:
Sub-specialty:
Current Home Address Home Telephone Is this # unlisted?
Home Fax If citizenship status or VISA status has changed, please indicate below and attach an explanation as well as pertinent documentation.
Citizenship/VISA status has changed.
Language(s) Spoken (other than English 2. Office Practice Information: (Complete only for information changed since last date of credentialing)
Check if entire section unchanged since last date of credentialing If you have more than one office site or more than one billing address or entity, please make a photocopy of this section before completing it and provide information for each site or billing entity (i.e., multiple tax identifiers), as needed. Indicate below whether the office is the primary or an additional site. (NOTE: Only one primary site should be designated.)
Primary Office Site #1 Additional Office Site #2 Group/Practice Name Type of Practice [ ] [ ] [ ]
Individual Partnership Group Corporation Hospital Based Teaching or Research Other (specify):
Address (Building, Street, Suite #)
County Answering Service/After-Hours Number Alternate Telephone Number Cell Phone Number Beeper/Pager Number E-Mail Address Long Range Beeper Number Medicare Number UPIN Number Medicaid Number Are you currently accepting new patients?
Have you closed your practice to any plans or programs?
By referral only Handicap Accessible?
Public Transit Available?
Does the office have other services available for disabled? (TTY, ASI, Mental/physical impairments, etc.)
If yes, list below what services are available Office Manager's Name Nurse Manager's Name Credentialing Contact Office Hours Check if not applicable Check if practitioner is not available to see patient during hours indicated Monday Tuesday Wednesday Thursday Friday Saturday Sunday Services Provided (Please check below if these services are available)
Lab Services On-Site Reference Lab Name:
CLIA Number and Type of Certification:
Radiology Services EKG Sigmoidoscopy Audiology Services Treadmill Other (Please list):
List any special diagnostic or treatment procedures performed in your office: 12/02; 3/03; 11/03; 1/04; 5/04 Confidential and Privileged Peer Review Pursuant to WV Code 30-3C-1 et.seq Page 3 State of West Virginia Recredentialing Form: Misrepresentation of any statements and information provided by you in support of this application shall be considered fraudulent and may result in denial or revocation of appointment. (If more space is needed, please supply the information in a separate sheet and attach.)
Patient Population Do you limit the age of patients you treat?
If yes, what ages do you treat?
Minimum:
Maximum:
Remittance/Billing Information (NOTE: Must match box 33 on HCFA/CMS 1500)
Are all services payable to one practice or group name/address?
Group/Practice Name (Check Payable To):
Address (Building, Street, Suite #)
Billing Office Phone Number Billing Manager’s Name Tax ID Number (must match W-9)
Name affiliated with Tax ID Number (must match W-9)
Business Interests Do you or your business entity own, operate, have an interest in, or participate in any medical enterprise or business?
If yes, provide details on separate sheet.
Do you have a financial relationship with a hospital, clinical lab, nursing home, pharmacy, radiology lab, emergency room, or any other medical related organization?
If yes, provide details on separate sheet.
Practice Classification Primary Care Physician (Family Practitioners, Internists, or Pediatricians who deliver primary health care services)
Specialist Physician (Physicians other than primary care physicians in their designated clinical practice)
Allied Health Professional (Licensed, certified, or registered non-physician practitioners of direct patient care services)
Dual Role (Serve as both a Primary Care Physician as well as a Specialist)
Directory Listing Should this office be listed in the directory?
Should this office receive correspondence?
Please indicate, in preference order, how you wish to be listed in the directory.
Primary Specialty:
Secondary Specialty:
After-Hours Coverage Do you provide 24-hour coverage?
Describe Coverage Do you have an answering service/machine?
Is your answering service/machine available at all times when you are not in the office?
List below other after-hours arrangements or special instructions to patients for after-hours care needs:
Back-up Coverage (Please list the name, specialty, and phone number of partner(s) or associate(s) or physician(s) covering your practice in your absence.)
Name Specialty Partner, Associate, Or Covering Phone Number Admitting Service Do you admit patients to the hospital under your own service?
If no, to whom do you admit?
Practitioner Extenders Please check any of the following practitioner extender types and list individual names who you either employ or utilize for direct patient care.
Physician’s Assistant:
Nurse Practitioner :
Nurse Midwife:
Other (specify):
Workers’ Compensation Information Do you accept Workers’ Compensation Patients?
If yes, please provide the following information:
a. Are staff trained in identification and care of patients with work-related illness/injury and provide care/services with an active return to work philosophy?
b. Modified or alternative duty is actively evaluated for each Workers’ Compensation claimant.
c. Office will accommodate urgent walk-ins (or non-urgent appointments within 48 hours) to treat injured or ill workers and facilitate their return to work, if possible.
d. Staff are available and willing to provide compensation representatives information regarding a claimant’s care.
NOTE: Section 3 (Medical/Professional Education) and Section 4 (Professional Training) have been intentionally omitted. If additional formal education/training has been obtained since the date of last credentialing, please complete Sections 3 and 4 from the Credentialing application as appropriate and attach.
- Medical/Professional Education:
Please provide the following information for your medical school of graduation.
Name of School Degree Received Dates of Attendance (List Mo/Yr)
Phone # (if known)
Graduation Date NOTE: The remainder of Section 3 (Medical/Professional Education) and Section 4 (Professional Training) have been intentionally omitted. If additional formal education/training has been obtained since the date of last credentialing, please complete Sections 3 and 4 from the Credentialing application as appropriate and attach.
- State License(s): List all current professional licenses (Submit copy of current licenses)
License # Issue Date Status (Please check)
Is/was license restricted?
Reason License is/was Inactive or Restricted Does the scope of your practice require the supervision of another practitioner?
If Yes, please list name of each supervising practitioner:
Practitioner Name:
- Certifications/Registrations Check here if entire section is not applicable to applicant or if no changes since last credentialing date.
Not applicable Federal DEA Certificate (Submit copy of current DEA Certificate)
Certificate # Unlimited?
If no, explain:
Not applicable State DEA or CDS Certificate(s)
(Submit copy of current State Controlled Dangerous Substance Certificates, if Applicable)
Certificate # Unlimited?
If no, explain :
Other Certificate(s)/Formal Training (Please check below if currently certified. Submit copy(s))
Basic Life Support (BLS Advanced Cardiac Life Support (ACLS)
Pediatric Advanced Life Support (PALS)
Advanced Trauma Life Support (ATLS)
Neonatal Advanced Life Support (NALS)
Anesthesia Permit Health Care Practitioner (Core C)
Neonatal Resuscitation Program (NRP Therapeutics Classification Number (Optometrists only)
Other (please list below or on a separate sheet and include descriptions):
- Specialty Board Certification: Complete for information changed SINCE DATE OF LAST CREDENTIALING. Submit copies of board certifications and/or qualification confirmation letter.
Check here if entire section is not applicable to applicant or if no changes since last credentialing date.
Are you board certified?
(If yes, list below)
Certifying Board Name & Specialty Initial Certification Most Recent Recertification Date Next Expiration If not certified, are you qualified to sit for the examination?
If not certified, please indicate your status in the certifying process:
Failed to pass specialty board examination ! How many times have you taken the exam but failed to pass? ! Last date(s) exam was taken:
Date(s) board examination was taken/retaken and date board exam is scheduled, if applicable: ! Date(s) taken/retaken: ! Date scheduled, if applicable:
Not eligible to take specialty boards Not planning to take specialty boards Admissible with exam pending NOTE: Section 8 (Professional Peer References) has been intentionally omitted; however, may be required by specific entity in which case Section 8 from Credentialing application may be required as indicated on Page 1.
- Hospital/Health Care Entity Affiliations:
List ALL health care facilities at which you currently have privileges or have had privileges SINCE DATE OF LAST CREDENTIALING. Explain gaps greater than three (3) months during the period in Section 11.
Name of Current Primary Hospital Affiliation Admits/Month If yes, explain If yes, explain Admits/Month If yes, explain 9. Additional Affiliations:
(Photocopy this page for additional affiliations)
Admits/Month Admits/Month 10. Work History/Experience:
List in Chronological order (beginning with current) all current and previous professional work history SINCE THE LAST CREDENTIALING DATE, including Military Service. You must explain gaps greater than three (3) months in Section 11. (If additional space is needed, please photocopy this page and attach.)
- Time Gaps Provide information for all time frames of three (3) months or more SINCE LAST CREDENTIALING DATE that are not covered in Hospital/Facility Affiliations and/or Work History/Experience sections (such as extended travel, maternity leave, relocation, etc.).
Section Dates Explanation Hospital/Health Care Entity Affiliations Work History/Experience 12. Continuing Education Requirements A. Have you completed the continuing education hours as required b your State Licensing Board during the past two (2) years OR the required CME/CEU hours (if applicable) from the State licensing board in which you are currently practicing?
B. Attach certificates as noted on Page 1 for the CME/CEU sessions you completed in the last two (2) years (if required by Credentialing entity).
- Professional Associations/Organizations (optional for recredentialing)
List the associations/organizations related to your profession in which you are a member. Please include dates of affiliations. Include faculty appointments.
Check here if not applicable 14. Professional Liability Insurance Coverage:
Submit a copy of your current professional liability insurance coverage face sheet showing coverage in your practice specialty. Please list current and previous insurance carriers SINCE THE LAST CREDENTIALING DATE beginning with most current. (If additional space is needed, please photocopy this page and attach.)
Current Insurance Carrier Coverage Effective Date Coverage Termination Date $ million/occurrence $ million/aggregate Previous Insurance Carrier Coverage Effective Date Coverage Termination Date $ million/occurrence $ million/aggregate Previous Insurance Carrier Coverage Effective Date Coverage Termination Date $ million/occurrence $ million/aggregate Previous Insurance Carrier Coverage Effective Date Coverage Termination Date $ million/occurrence $ million/aggregate 15. Professional Liability Insurance Coverage Disclosure: (Respond only for actions since date of last credentialing.)
If the answer to any of these questions is Yes, please provide a full explanation of the details of each and every matter on the attached Professional Liability Information Addendum. The explanation must include the name of the court in which the suit was filed, the caption and docket number of the case, and the name and address of the attorney defending you, and all other relevant details. Include suits in which a judgment or settlement was made against a professional corporation of which you are/were a member, shareholder, or employee in any matter in which you were involved in the patient’s care.
A. Has your professional liability insurance coverage ever been terminated by action of the insurance company?
B. Have you ever been denied professional liability insurance coverage?
C. Has any (current or previous) professional liability insurance carrier excluded any specific procedures or specific area of practice (e.g., obstetrics, surgery, etc.) from your coverage?
D. During the time of your professional practice, have you had any professional liability claims, suits, settlements, or judgements filed against you or are any currently pending?
E. Have any restrictions ever been placed on your professional liability insurance coverage?
F. Have you ever practiced without professional liability coverage?
G. Are there any incidents for which you have been contacted by an attorney regarding potential professional liability (e.g., settlement requests, writ of summons, etc.)?
Professional Liability Information Addendum (Photocopy this form for each case/action)
Please supply the following and sign and date this form:
Information for each professional liability action you have had taken against you, with any actions or change of status SINCE LAST DATE OF CREDENTIALING, including those pending.
Information for each settlement, or decision for the plaintiff that has occurred on your behalf SINCE LAST DATE OF CREDENTIALING.
Practitioner Signature and Date All information is held in strict confidence and used for credentialing and recredentialing purposes only. Failure to supply sufficient details may prevent your application from being approved. In addition to completion of this form, practitioner may also submit any additional supporting documentation.
Check here if entire section is not applicable to applicant (and sign below even if no suits or settlements).
Check here if no professional liability actions/claims filed (and sign below even if no suits or settlements).
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Case Number 2. Carrier Name 3. Name of Plaintiff 4. Date of Incident 5. Date Filed 6. Date Closed 7. What was/is your status in the case?
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What is the status of the case?
Primary Defendant Co-Defendant Other, please explain:
Dropped Pending Settled Out of Court Found for Defendant Dismissed Without Payment Found for Plaintiff Under Appeal 9. Amount of any Settlement or Award?
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Date of any Settlement or Award Please explain the following in detail. (If an item does not apply please check “N/A”)
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What was the alleged harm to the patient?
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What were you alleged to have done incorrectly or failed to do?
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Describe the patient’s illness and related effects of the alleged harm.
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Describe any other details you believe are pertinent to the case.
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Identify any other parties named in the suit.
Practitioner Signature (REQUIRED)
Date (REQUIRED)
- Practice Disclosure Information: (Complete based upon activity SINCE LAST DATE OF CREDENTIALING If the answer to any question below is yes since your last recredentialing date, please provide a full explanation of the details on a separate sheet and attach.
A. Have any investigations been initiated or any pending against you by any state licensure board, registration board, or regulatory agency?
B. Has your license to practice in any state ever been voluntarily or involuntarily relinquished, restricted, denied, reduced, limited, suspended, placed on probation, revoked, or subject to any disciplinary action including reprimand?
C. Have you ever been suspended, sanctioned, or otherwise restricted from participating or been the subject of an investigation in any private, federal, or state health insurance program (e.g., Medicare, Medicaid)?
D. Has your narcotics (DEA) registration certificate (federal or state) ever been voluntarily or involuntarily relinquished, limited, suspended, not renewed, placed on probation, revoked, or challenged?
E. Have you ever been convicted of or plead no contest to any criminal (felony or misdemeanor) charges including a drug or alcohol-related offense or motor vehicle offenses, but not including minor traffic or parking violations? Are any such proceedings currently pending?
F. Have you ever had an academic appointment denied, limited, revoked, suspended, reduced, placed on probation, not renewed, or other adverse action taken?
G. Have you ever been refused membership on the medical or allied health staff of any hospital or institution or been denied advancement in staff status?
H. Has your employment, medical staff status, appointment, reappointment, or clinical privileges, or scope of practice ever been voluntarily or involuntarily suspended, restricted, reduced, revoked, denied, relinquished, not been renewed or subjected to probationary conditions or limited at any hospital, managed care organization or other health care entity?
I. Have you ever been denied membership or renewal, or been reprimanded, censured, suspended, revoked, placed on probation, or otherwise sanctioned by any health care organization, including but not limited to, hospitals, HMOs, PPOs, IPAs, PHOs, professional associations or societies, professional standards review organization or peer review organizations, or any other health care facilities based on professional competence?
J. Have you ever withdrawn your application for appointment, reappointment or request for clinical privileges or resigned from the medical or allied health staff of a hospital, managed care organization, or other health care entity while under investigation or before a decision about your appointment or reappointment or clinical privileges was rendered by the governing board of any hospital, managed care organization or any other health care entity?
K. Have you ever been allowed to resign your position or voluntarily relinquish specific clinical privilege rather than face any charge or investigation on the part of the medical staff of a hospital, managed care organization, or other health care entity?
L. Are there currently pending adverse actions on your employment, medical staff appointment, reappointment, clinical privileges or scope of practice at any hospital, managed care organization, or other health care entity?
M. Has any investigation (other than normal performance improvement reviews) involving your clinical practice, competence or professional conduct ever been initiated by an hospital, managed care organization, governmental agency, other health care entity, or branch of the armed forces?
N. Has your request for any specific clinical privileges or scope of practice ever been denied (as a result of disciplinary action) or granted with stated limitations or conditions (aside from ordinary initial probationary requirements of proctorship)? Are such proceedings currently pending?
O. Do you have any knowledge of any civil actions pending against you by any hospital, law enforcement agency, professional group or society?
P. Have you had any charges of unprofessional conduct brought against you?
Q. Have you had any charges of fraud brought against you?
R. Have you received any confirmed Quality Citations from a Peer Review Organization (PRO) in the last two (2) years? If you answered yes, on a separate sheet, indicate the address of the PRO that cited you, the circumstances of the citation and the number of points you were fined.
Health Status Note: Your application will be processed in the usual manner regardless of how you answer questions A and B. If you have answered “No” to question A or B, please explain completely on a separate sheet. If you are found to be qualified, a representative will contact you to determine what accommodations are necessary and feasible to allow you to practice safely.
A. Are you physically and mentally able to perform all the essential functions or services necessary to exercise the privileges or services applied for with or without a reasonable accommodation?
B. Are you able to perform these functions without significant risk of injury to yourself or others C. Do you illegally use drugs?
Have you used illegal drugs within the last two years?
D. Do you currently take any medications that may affect your ability to perform the clinical privileges or scope of practice requested competently and safely?
Health Care Entity WEST VIRGINIA PRACTITIONER ATTESTATION/AUTHORIZATION AND RELEASE OF INFORMATION By submitting this attestation/authorization and release of information form in conjunction with the West Virginia Recredentialing Form (WVRF) and/or the West Virginia Practitioner Attestation/Authorization, I understand and agree as follows:
I understand and acknowledge that, as an applicant for medical staff membership and/or participating status with the Health Care Entity indicated on the WVRF for initial credentialing or recredentialing, I have the burden of producing adequate information for proper evaluation of my competence, character, ethics, mental and physical health status, and/or other qualifications.
I further understand and acknowledge that the Health Care Entity or designated Agent will investigate the information in this application. By submitting this application, I agree to such investigation and to the disciplinary reporting and information exchange activities of the Health Care Entity as part of the verification and credentialing process.
I authorize all individuals, institutions, and entities or organizations with which I am currently or have been associated and all professional liability insurers with which I have had or currently have professional liability insurance, who may have information bearing on my professional qualifications, ethical standing, competence, and mental and physical health status to release the aforementioned information to the designated Health Care Entity(ies), their staffs and agents.
I consent to the inspection of records and documents that may be material to an evaluation of qualifications and my ability to carry out the requested clinical privileges or provide services I request. I authorize each and every individual and organization in custody of such records and documents to permit such inspection and copying. I am willing to make myself available for interviews if required or requested.
I attest to the accuracy and completeness of the information provided. I understand and agree that any misstatements in or omissions from the WVRF Attestation/Authorization and attachments hereto may constitute cause for denial of the application or summary dismissal or termination of membership/clinical privileges/participation agreement.
I agree to exhaust all available procedures and remedies as outlined by in the bylaws, rules, regulations, and policies, and/or contractual agreements of the Health Care Entity(ies) where I have membership and/or clinical privileges/participation.
I understand that completion and submission of the WVRF Attestation/Authorization and Release of Information does not automatically grant me membership or clinical privileges/participating status with the Health Care Entity(ies) indicated on the WVRF or Attestation/Authorization.
I further acknowledge that I have read and understand the foregoing Attestation/Authorization and Release of Information. A photocopy of this Attestation/Authorization and Release of Information shall be as effective as the original, and authorization constitutes my written authorization and request to communicate any relevant information and to release any and all supportive documentation regarding this application/attestation/authorization.
- I release from liability any and all individuals and organizations who provide information to the credentialing entity in good faith and without malice concerning my professional qualifications and competence, and the credentialing entity, from liability for their acts performed and statements made relating but not limited to verifying, evaluating and acting upon my credentials and qualifications.
Print Name Here Signature: Date:
Note: Through above signature, I hereby affirm that contents are current, accurate and complete as of the signature date.
Modification to the wording or format of the WVRF/Attestation/Authorization and Release of Information may invalidate an application.
Credentialing Entity may supplement additional Attestation/Authorization/Release of Information through an additional release document as required by the entity.
The Entities will treat this application and any information secured in connection therewith in strict confidence in accordance with the Entities’ policies and/or Medical Staff Bylaws and preserve with all reasonable safeguards the privacy of the Applicant.
ADDENDUM
VERIFICATION OF PROFESSIONAL LIABILITY
I, the undersigned, authorize my CURRENT professional liability insurance carrier, (Enter Current Professional Liability Insurance Carrier Name)
(Enter Street Address) (City) (State & Zip) to send verification of my professional liability coverage, to include dates of coverage, amounts of coverage, and any limitations in coverage, to . is to hereinafter be a Certificate Holder and is to be notified of the amount of my coverage and any future changes in my insurance status, to include all information regarding claims history (but not necessarily limited to judgments entered, claims settled, cases and lawsuits pending) and any restriction regarding specific privileges which may be excluded from coverage.
I will notify of any changes in Professional Liability carriers so that another Verification of Professional Liability form can be completed.
Practitioner’s Signature Date Printed Name (Instructions: Please complete, sign, date and return to entity named above with your initial application.)
APPENDIX C
LIST OF PRACTITIONERS WHO SHALL USE THE UNIFORM FORMS
Acupuncturists Audiologists Chiropractors Dental Assistants Dental Hygienists Dentists Dieticians (RD)
Emergency Medical Technicians (EMT) including but not limited to Basic, Cardiac/Critical, Intermediate and Paramedic Homeopaths Licensed Practical Nurses and Licensed Vocational Nurses (LVN)
Licensed Professional Counselors (including but not limited to alcohol, substance abuse and family/marriage counselors)
Mental Health Counselors Massage Therapists Naturopaths Nuclear Medicine Technologists Nurse Anesthetists (CRNA)
Nurse Midwives (CNM)
Nurse Practitioners (NP)
Nutritionists Occupational Therapists Optometrists Orthotics/Prosthetics Fitters Pharmacists and Nuclear Pharmacists Physical and Rehabilitation Therapists Physicians Assistants, Allopathic and Osteopathic Physicians, Residents and Interns, Allopathic and Osteopathic Podiatrists Psychologists, Clinical Radiation Therapy Technologists Radiologic Technologists Registered Nurses (RN)
Respiratory Therapists Respiratory Therapy Technicians Social Workers, Clinical Speech/Language Pathologists
APPENDIX C
List of Practitioners Who Shall Use the Uniform Forms Acupuncturists Audiologists Chiropractors Dental Assistants Dental Hygienists Dentists Dieticians (RD)
Emergency Medical Technicians (EMT) including but not limited to Basic, Cardiac/Critical, Intermediate and Paramedic Homeopaths Licensed Practical Nurses and Licensed Vocational Nurses (LVN)
Licensed Professional Counselors (including but not limited to alcohol, substance abuse and family/marriage counselors)
Mental Health Counselors Message Therapists Naturopaths Nuclear Medicine Technologists Nurse Anesthetists (CRNA)
Nurse Midwives (CNM)
Nurse Practitioners (NP)
Nutritionists Occupational Therapists Optometrists Orthotics/Prosthetics Fitters Pharmacists and Nuclear Pharmacists Physical and Rehabilitation Therapists Physicians Assistants, Allopathic and Osteopathic Physicians, Residents and Interns, Allopathic and Osteopathic Podiatrists Psychologists , Clinical Radiation Therapy Technologists Radiologic Technologists Registered Nurses (RN)
Respiratory Therapists Respiratory Therapy Technicians Social Workers, Clinical Speech/Language Pathologists State of West Virginia Credentialing Form: Misrepresentation of any statements and information provided by you in support of this application shall be considered fraudulent and may result in denial or revocation of appointment. (If more space is needed, please supply the information on a separate sheet and attach.
State of West Virginia Credentialing Form: Misrepresentation of any statements and information provided by you in support of this application shall be considered fraudulent and may result in denial or revocation of appointment. (If more space is needed, please supply the information on a separate sheet and attach.
State of West Virginia Credentialing Form: Misrepresentation of any statements and information provided by you in support of this application shall be considered fraudulent and may result in denial or revocation of appointment. (If more space is needed, please supply the information on a separate sheet and attach.
State of West Virginia Credentialing Form: Misrepresentation of any statements and information provided by you in support of this application shall be considered fraudulent and may result in denial or revocation of appointment. (If more space is needed, please supply the information on a separate sheet and attach.
State of West Virginia Recredentialing Form: Misrepresentation of any statements and information provided by you in support of this application shall be considered fraudulent and may result in denial or revocation of appointment. (If more space is needed, please supply the information in a separate sheet and attach.)
State of West Virginia Recredentialing Form: Misrepresentation of any statements and information provided by you in support of this application shall be considered fraudulent and may result in denial or revocation of appointment. (If more space is needed, please supply the information in a separate sheet and attach.)
State of West Virginia Recredentialing Form: Misrepresentation of any statements and information provided by you in support of this application shall be considered fraudulent and may result in denial or revocation of appointment. (If more space is needed, please supply the information in a separate sheet and attach.)
State of West Virginia Recredentialing Form: Misrepresentation of any statements and information provided by you in support of this application shall be considered fraudulent and may result in denial or revocation of appointment. (If more space is needed, please supply the information in a separate sheet and attach.)
State of West Virginia Recredentialing Form: Misrepresentation of any statements and information provided by you in support of this application shall be considered fraudulent and may result in denial or revocation of appointment. (If more space is needed, please supply the information in a separate sheet and attach.)
State of West Virginia Recredentialing Form: Misrepresentation of any statements and information provided by you in support of this application shall be considered fraudulent and may result in denial or revocation of appointment. (If more space is needed, please supply the information in a separate sheet and attach.)
Series 90 Regulation of Opioid Treatment Programs
W. Va. Code R. § 64-90 Regulation of Opioid Treatment Programs
64CSR90
TITLE 64
LEGISLATIVE RULE
DIVISION OF HEALTH
DEPARTMENT OF HEALTH AND HUMAN RESOURCES
SERIES 90
REPEALED. Effective August 12, 2013.
Series 91 Newborn Screening System
W. Va. Code R. § 64-91-1 General
1.1. Scope. -- This rule directs the Bureau for Public Health, in cooperation with other state agencies and attending physicians, to provide medical, dietary, and related assistance to children determined to be afflicted with any disease specified in W. Va. Code §16-22-3, and certain other diseases specified by the Bureau for Public Health. The rule provides for a means of payment for the required screenings, and any further referral or treatment services considered necessary by the Bureau for Public Health to implement the provisions of the statute on newborn screening. This rule should be read in conjunction with W. Va. Code §16-22-3 and §16-22A-1 et seq. and the rule on Newborn Hearing Screening, 64CSR24. The W. Va. Code is available in public libraries and on the Legislature’s website, http://wvlegislature.gov/
1.2. Authority. -- W. Va. Code §16-1-4, §16-22-3 and §16-22A-3.
1.3. Filing Date. -- May 1, 2024.
1.4. Effective Date. -- May 1, 2024.
1.5. Sunset Provision. -- This rule shall terminate and have no further force or effect on August 1, 2029.
1.6. The fee for a newborn screening system kit established in section 6 of this rule supersedes the amount in the Bureau for Public Health’s “Fees for Services” rule, 64CSR51, Appendix A.
W. Va. Code R. § 64-91-2 Application and Enforcement
2.1. Application. -- This rule applies to all infants born in West Virginia and to the hospital or birthing facility in which an infant is born, the parents or legal guardians, the physician attending a newborn child, or any person attending a newborn child not under the care of a physician and the director of the state laboratory performing mandatory newborn screening tests.
2.2. Enforcement. -- This rule is enforced by the Commissioner of the Bureau for Public Health.
W. Va. Code R. § 64-91-3 Definitions
3.1. Birthing Facility. -- Any licensed medical facility that offers birthing services.
3.2. Bureau. -- The Bureau for Public Health in the West Virginia Department of Health and Human Resources. The bureau is the agency responsible for administering the Newborn Screening System.
3.3. Commissioner -- The Commissioner of the Bureau for Public Health or his or her designee.
3.4. Newborn Screening. -- The statutorily mandated screening of newborns by hospitals, birthing facilities, physicians or others.
3.5. Newborn Screening System. -- The coordinated effort by the bureau and West Virginia physicians who deliver and care for children, to ensure that each newborn child is screened for metabolic disorders before discharge from birthing facilities. Infants identified with a disorder must receive continuing care and treatment provided through a collaborative effort between the primary physician, medical specialist, the bureau, and community support services.
3.6. Office of Maternal, Child and Family Health. -- The office in the bureau that provides coordination and leadership in working with public and private community partners and families to assure the availability and use of health care for all mothers, infants and children including children with special health care needs.
3.7. Primary Care Provider. -- The physician, physician’s assistant, nurse, nurse practitioner or other licensed medical professional responsible for the infant’s health services during and/or after discharge from the birthing facility.
3.8. State Laboratory. -- The Department of Health and Human Resources, Bureau for Public Health’s Office of Laboratory Services, that supplies newborn screening services to all birthing facilities in the state.
W. Va. Code R. § 64-91-4 When Screening is Required
4.1. W. Va. Code §16-22-3 requires that all infants born in the state be screened for detection and control of diseases in newborn children as listed in section 5.
4.2. When the birth takes place in a licensed birthing facility the primary care provider must perform or cause to be performed newborn screening as listed in section 5 within 48 hours of birth, or before discharge from the birthing facility, whichever comes first.
4.3. If an infant is born in a non-hospital or non-birthing facility, including a home, the person in attendance at the birth must perform or cause to be performed the newborn screening as listed in section 5 within 48 hours of the birth.
4.4. If a specimen is unacceptable or a positive screen result occurs, the primary care provider must perform or cause to be performed a second screen.
W. Va. Code R. § 64-91-5 Complete list of diseases and conditions
5.1. Every infant born in West Virginia must be screened for the diseases and conditions contained in this section.
5.2. Adrenoleukodystrophy
5.3. Argininosuccinic acidemia, ASA;
5.4. Beta-ketothiolase deficiency, BKT;
5.5. Biotinidase deficiency, BIOT;
5.6. Carnitine uptake defect, CUD;
5.7. Citrullinemia, CIT;
5.8. Congenital adrenal hyperplasia, CAH;
5.9. Cystic fibrosis, CF;
5.10 Galactosemia, GALT;
5.11. Glutaric acidemia type I, GAI;
5.12. Hearing deficiency, HEAR;
5.13. Hemoglobinopathies; including:
5.13.a. Hemoglobin S/Beta-thalassemia, Hb S/Th;
5.13.b. Sickle cell anemia, Hb SS;
5.13.c. Sickle C disease, Hb S/C;
5.14. Homocystinuria, HCY;
5.15. 3-Hydroxy-3-methylglutaric aciduria, HMG;
5.16. Hypothyroidism, CH;
5.17. Isovaleric acidemia, IVA;
5.18. Long-chain hydroxyacyl-CoA dehydrogenase deficiency, LCHAD;
5.19. Maple syrup urine disease, MSUD;
5.20. Medium-chain acyl-CoA dehydrogenase deficiency, MCAD;
5.21. 3-Methylcrotonyl-CoA carboxylase deficiency, 3MCC;
5.22. Methylmalonic acidemia - Cbl A and Cbl B forms, Cbl A,B;
5.23. Methylmalonic acidemia-mutase deficiency form, MUT;
5.24. Multiple carboxylase deficiency, MCD;
5.25. Phenylketonuria, PKU;
5.26. Propionic acidemia, PROP;
5.27. Trifunctional protein deficiency, TFP;
5.28. Tyrosinemia type I, TYRI;
5.29. Very long-chain acyl-CoA dehydrogenase deficiency, VLCAD;
5.30. Lysosomal Storage Disorders;
5.31. X-Linked Adrenoleukodystrophy, X-ALD; and
5.32. Spinal Muscular Atrophy, SMA.
W. Va. Code R. § 64-91-6 Screening Protocol
6.1. The primary care provider must perform, or cause to be performed, newborn screening listed in section 5 shortly after birth and before discharge from the birthing facility and send the specimen to the state laboratory to perform the tests.
6.2. The screening must be performed by trained personnel, according to the Clinical Laboratory Improvement Amendments (CLIA) standards as recommended by the American Academy of Pediatrics.
6.3. The Commissioner may update or modify the screening procedures according to screening protocol, technology, and current national standards.
6.4. If the primary care provider is unable to screen or cause to have screened the infant before discharge, then the primary care provider must refer the infant for an outpatient newborn screening.
6.5. For infants born in a non-hospital or non- birthing facility, including a home, the primary care provider must order an outpatient newborn screen.
6.6. A specimen must be collected on collection kits obtained through the state laboratory.
6.7. A specimen must be submitted to the state laboratory within 24 hours of collection through the U.S. mail or have the specimen ready for pick-up by courier service at a designated time and location.
W. Va. Code R. § 64-91-7 Screening Fee Schedule
7.1. The bureau may bill the birthing facility or individual attending the birth for services provided for each newborn screen consistent with prevailing health insurance reimbursement rates for newborn screening to cover the administrative, laboratory, and follow-up costs associated with the performance of screening tests required by this rule.
7.2. No newborn may be denied testing required by this rule because of inability of the newborn’s parents or legal guardian to pay the prescribed fee.
7.3. The bureau will periodically review the newborn screening program to determine the efficacy and cost-effectiveness of the program and determine whether adjustments to the program are necessary to protect the health and welfare of this state’s newborns, and to maximize the number of newborn screenings that may be conducted with the funding available for the screenings.
7.4. The bureau shall prepare an annual report to be submitted to the legislature, and to be made available to any interested party, that will include actual expenses incurred and revenue generated by the newborn screening system each year.
W. Va. Code R. § 64-91-8 Screening Reporting and Assistance to Afflicted Children
8.1. The birthing facility must record or cause to be recorded the newborn screening results in the infant’s medical record.
8.2. Positive results on any screen specified in section 5, or any other diseases specified by the bureau, must be promptly reported to the bureau and the primary care provider by the director of the state laboratory performing the test.
8.3. The primary care provider must report all newborn screening results to the infant’s parents or legal guardian.
8.4. Assistance with referrals must be offered by the bureau in cooperation with other state agencies to children determined to be afflicted with any disease specified in section 5 for medical and dietary needs.
8.5. When an infant is born in a non-hospital or non-birthing facility, including a home, the provisions of subsection 4.3. apply.
W. Va. Code R. § 64-91-9 Confidentiality
9.1. Confidential information obtained while performing the required screenings may only be disclosed to:
9.1.a. Reporting sources;
9.1.b. Persons demonstrating a need essential to health-related research or care of the infant; or
9.1.c. As required by law.
9.2. Prior to receipt of confidential information, the requestor must agree to maintain the confidentiality and privacy of the information as required by law.
Series 92 Clandestine Drug Laboratory Remediation
W. Va. Code R. § 64-92-1 General
1.1. Scope. -- This legislative rule establishes procedures and standards for the licensure and training of persons who engage in activities related to the remediation of clandestine drug laboratories; it also identifies the responsibilities of residential property owners and law enforcement with regard to the identification and remediation of clandestine drug laboratories.
1.2. Authority. -- W. Va. Code §16-1-4 and §60A-11-3.
1.3. Filing Date. – April 4, 2022.
1.4. Effective Date. – May 1, 2022.
1.5. Sunset Provision. -- This rule shall terminate and have no further force or effect upon August 1, 2027.
1.6. Application. -- This rule applies to all owners of residential properties which have been used as clandestine drug laboratories; all persons who perform the work of clandestine drug laboratory remediation including: technicians, contractors, training providers, and law enforcement investigating clandestine drug laboratories.
1.7. Enforcement. -- This rule is enforced by the commissioner.
W. Va. Code R. § 64-92-2 Definitions
2.1. “AIHA” means the American Industrial Hygiene Association.
2.2. “Applicant” means any person who is applying for a license to perform the work of clandestine drug laboratory remediation, including technicians, contractors, and training providers.
2.3. “Clandestine drug laboratory” means the area or areas where controlled substances, or their immediate precursors, have been, or were attempted to be, manufactured, processed, cooked, disposed of or stored and all proximate areas that are likely to be contaminated as a result of such manufacturing, processing, cooking, disposing, or storing.
2.4. “Clandestine drug laboratory remediation contractor” means a person who enters into a contract for a clandestine drug laboratory remediation project.
2.5. “Clandestine drug laboratory remediation technician” means a person who works on clandestine drug laboratory remediation projects, specifies work practices to be used, conducts sampling, and is certified and licensed.
2.6. “Commissioner” means the commissioner of the West Virginia bureau for public health or his or her designee.
2.7. “Composite Sample” means the use of multiple discrete or individual samples as a single sample, results are calculated by dividing the laboratory result by the total area sampled.
2.8. “Controlled substance” means the same as the term defined in W. Va. Code §60A-1-101, as a drug, substance, or immediate precursor in schedules I through V of W. Va. Code §60A-2-201, et seq.
2.9. “Department” means the West Virginia department of health and human resources.
2.10. “Discrete Sample” means the use of individual 100 square centimeters (cm2) samples taken at individual, specific and discrete locations.
2.11. “EPA” means the United States environmental protection agency.
2.12. “Immediate precursor” means a substance which the West Virginia board of pharmacy has found to be, and by rule designates as being, the principal compound commonly used or produced primarily for use and which is an immediate chemical intermediary used or likely to be used in manufacture of a controlled substance, the control of which is necessary to prevent, curtail or limit manufacture.
2.13. “Law-enforcement agency” means the West Virginia State Police or any other policing agency of the state or of any political subdivision of the state.
2.14. “OSHA” means the United States department of labor occupational safety and health administration.
2.15. “Person” means a corporation, partnership, sole proprietorship, firm, enterprise, franchise, association or any individual or entity.
2.16. “Plan Review” means the clandestine drug laboratory preliminary remediation plan review form available online at https://www.wvdhhr.org/rtia/pdf/Preliminary%20Remediation%20Plan%20Checklist%20(1).pdf.
2.17. “Remediation” means the act of rendering safe and usable for the purposes for which it is intended, residential property, as defined in subsection 2.18 of this section, or any structure appurtenant to the residential property, or other structure on the residential property that has been used for the manufacture or consumption of methamphetamines, or other illicit drug products.
2.18. “Residential property” means any building or structure to be primarily occupied by people, either as a dwelling or as a business, including, but not limited to, a storage facility, a mobile home, manufactured home or recreational vehicle, hotel or motel that may be sold, leased, or rented for any length of time.
2.19. “Residential property owner” means the person holding record title to residential property as the term is defined in subsection 2.18 of this section.
2.20. “Wipe sample” means a sample collected by wiping a 100 square centimeter (cm2) area in accordance with accredited laboratory standard operating procedures.
W. Va. Code R. § 64-92-3 License Required, Procedures, Application, and Qualifications
3.1. No person shall perform the work of a clandestine drug laboratory remediation technician or contractor without possessing a valid license issued under this rule.
3.2. Persons applying for a license shall be at least 18 years of age to be licensed under this rule.
3.3. A license expires either one year or two years from the last day of the month in which it is issued at the option of the applicant.
3.4. The commissioner may refuse to issue a license and retain the license fee if the applicant fails to satisfy the requirements of this rule.
3.5. The commissioner may refuse to issue a contractor’s license if he or she finds that the applicant has knowingly falsified or attempted to falsify documents related to any project or license within the purview of the department.
3.6. The commissioner shall provide a written notice of denial and an opportunity for reapplication to all applicants.
3.7. Applicable licensure fees, set forth in Table 64-92A of this rule, shall be enclosed with each license application. If the applicant chooses to apply for a two-year license, the amount of the fee to be enclosed with the license application must two times the amount set forth in in Table 64-92A of this rule.
3.8. The applicant, contractor, or an authorized agent or officer of the applicant or contractor shall sign the application.
3.9. License applications shall include the following:
3.9.1. For licensure as a contractor, the license number of a current certified clandestine drug laboratory remediation technician employed by the contractor;
3.9.2. For licensure of a clandestine drug laboratory remediation technician, applicant’s date of birth, a current certificate of training from a West Virginia licensed clandestine drug laboratory remediation training provider and proof of current OSHA 40-hour hazardous material training;
3.9.3. An applicant for a clandestine drug laboratory remediation technician license is subject to a criminal background check; and
3.9.4. Any other information relevant to clandestine drug laboratory remediation licensure requested by the Commissioner.
W. Va. Code R. § 64-92-4 Licensed Contractor Duties
4.1. Licensed clandestine drug laboratory remediation contractors shall:
4.1.1. Ensure that each of the contractor’s employees or agents who will be involved with a clandestine drug laboratory remediation project is properly licensed;
4.1.2. Not begin a clandestine drug laboratory remediation project until a preliminary remediation plan is submitted to and a notice to proceed is issued by the department;
4.1.3. Ensure that all work practices are in compliance with this rule, applicable OSHA requirements and all other applicable local, state, and federal requirements;
4.1.4. Use waste-disposal dumpsters, disposal sites, and methods which are in conformance with applicable federal, state, and local laws, rules, and regulations;
4.1.5. Have third-party final clearance sampling performed upon completion of remediation project;
4.1.6. Submit a final remediation report for each remediation project to the department within 10 days of receipt of final third-party analytical test results;
4.1.7. Supervise demolition of residential properties by licensed and certified contractors; and
4.1.8. Submit all analytical test results to the commissioner.
W. Va. Code R. § 64-92-5 Licensed Technician Duties
5.1. Licensed technicians shall:
5.1.1. Perform wipe sampling and initial assessment in accordance with this rule;
5.1.2. Submit initial assessment report to the clandestine drug laboratory remediation program; and
5.1.3. Perform final clearance sampling for remediation projects, which shall be by composite sampling, per room remediated and include a total of at least a discrete sample from each of a floor, wall, ceiling, and HVAC unit, vent, and return and be of an area at least 300 cm², but not more than a total area of 400 cm².
5.2. Any personal property not able to be effectively remediated due to porous surfaces such as carpeting, mattresses, clothing, or furniture, shall be disposed of in accordance with applicable federal, state, and local law. Any furniture and other personal items that were decontaminated shall be left inside residential property and discretely sampled separately.
5.3. Perform testing of the interior of vehicles suspected of contamination from a clandestine drug laboratory. Vehicle interior testing shall be a composite of four discrete samples, at least two of which shall be taken as close as possible to the ventilation system. Any vehicle remediation shall include the ventilation system.
W. Va. Code R. § 64-92-6 Responsibilities of Law Enforcement Agencies
6.1. The law enforcement agency responsible for the identification of a clandestine drug laboratory shall:
6.1.1. Notify the residential property owner within 24 hours of the identification;
6.1.2. Notify real property occupants of regulations pertaining to securing and vacating property;
6.1.3. Secure from public access the clandestine drug laboratory, any controlled substances, and immediate precursors;
6.1.4. If probable cause exists, impound vehicles that contain clandestine drug laboratories and, or equipment, precursors, etc. as defined under section 2 and to the extent practical, maintain vehicle secured and unoccupied until testing is completed by licensed Clandestine Drug Laboratory Remediation Technician and either the initial or post-remediation analytical test results are at or below 1.0 µg of methamphetamine residue per 100 square centimeters (1.0 µg /100 cm²) or the vehicle is demolished;
6.1.5. Notify the department within 24 hours of the identification of a clandestine drug laboratory, and provide name and mailing address of property owner and physical location of the clandestine drug laboratory;
6.1.6. Within 48 hours, provide the department with a legible manifest of all chemical substances removed from the identified clandestine drug laboratory on a form prescribed by the department for that purpose available online at https://www.wvdhhr.org/rtia/pdf/Law%20Enforcement%20Notification%20Form.pdf; and
6.1.7. Provide the commissioner with any other requested information.
W. Va. Code R. § 64-92-7 Responsibilities of Residential Property Owners
7.1. A residential property owner who has been notified by a law enforcement agency or becomes aware of a clandestine drug laboratory on his or her property shall:
7.1.1. Ensure the residential property remains unoccupied and secured until analytical test results indicate a level of contamination at or below 1.0 µg /100 cm2, a certificate of remediation completion is issued for the property by the department, or the property is properly demolished in compliance with 64CSR63 if applicable;
7.1.2. Within 60 days of notice of the existence of a clandestine drug laboratory, test, commence remediation, or demolish the residential property in accordance with this rule and any other applicable law;
7.1.3. In the case of a hotel, motel, or multi-unit building, all units or areas immediately adjacent to a unit or area within the hotel, motel, or multi-unit building that contained a clandestine drug laboratory and that is under the control of the residential property owner must be secured, vacated and tested in accordance with this rule, unless, however, a fire break wall separates adjoining units in a multi-unit building, the commissioner may determine to allow adjoining units to remain occupied pending testing and remediation;
7.1.4. When analytical testing shows a level of contamination of greater than 1.0 µg /100 cm2, contract within 60 days a licensed clandestine drug lab remediation contractor to either remediate or demolish the residential property in accordance with this rule; and
7.1.5. Conduct additional testing in accordance with the provisions of this rule as required by the commissioner.
7.2. A residential property owner may delegate, in writing, the responsibilities for compliance with this section to a person who is responsible for the operation of the residential property or to the person who contracts for the remediation or demolition and/or disposal of the property.
7.3. A residential property owner and any agent thereof shall disclose information regarding the identification of a clandestine drug laboratory on the residential property to any potential purchaser or occupant, including the location of the clandestine drug laboratory, remediation plans, related enforcement actions, and the issuance of any certificate of remediation completion by the department.
W. Va. Code R. § 64-92-8 Decontamination Levels
8.1. The post remediation, re-occupancy decontamination level for residential property where a clandestine drug laboratory has been identified is: 1.0 µg /100 cm² of area sampled by a licensed clandestine drug laboratory remediation technician.
8.2. The commissioner may request sampling for additional chemicals if the manifest of chemicals removed from the property indicates a need for further sampling.
8.3. All analytical laboratories used to analyze samples taken to comply with this rule shall be AIHA or EPA certified.
W. Va. Code R. § 64-92-9 Initial Assessment Report
9.1. An initial assessment report shall be submitted to the commissioner within 10 days of receipt of the initial analytical results and shall, at a minimum, contain the following:
9.1.1. An initial assessment, conducted by a licensed clandestine drug laboratory remediation technician, containing the following:
9.1.2.a. The name, signature, and license number of person who conducted the site assessment;
9.1.2.b. The date of initial assessment;
9.1.2.c. The physical address and legal description of property;
9.1.2.d. The name and address of property owner;
9.1.2.e. A physical description of the property, including GPS coordinates when practicable;
9.1.2.f. The age of property;
9.1.2.g. A source of potable water;
9.1.2.h. The status of utility connections;
9.1.2.i. A description of the heating, cooling, and ventilation systems;
9.1.2.j. If suspected asbestos containing materials are present, the absence or presence of asbestos verified by a licensed and certified asbestos inspector prior to any remediation, demolition, or disposal activities, and a copy of the asbestos inspection report shall be provided to the commissioner;
9.1.2.k. A general listing of items to be removed from the residential property for disposal;
9.1.2.l. Items requiring special handling for disposal; and
9.1.2.m. Any obvious safety hazards.
9.1.3. A legible site drawing of the property indicating:
9.1.3.a. A floor plan for each structure to be remediated;
9.1.3.b. The location of areas suggestive of contamination;
9.1.3.c. The location of any septic systems and water wells;
9.1.3.d. The distance to the nearest occupied dwelling;
9.1.3.e. The location of all out buildings;
9.1.3.f. The location of any distressed vegetation or dumping areas; and
9.1.4. Analytical sample results for all samples taken, including one blank per 10 samples taken, cross-referenced to the site drawing and to a photograph of each sample location; and
9.1.5. A quality control plan for sample collection including a sampling protocol.
9.2. Initial assessment reports shall contain any other information requested by the commissioner.
W. Va. Code R. § 64-92-10 Preliminary Remediation Plan
10.1. The preliminary remediation plan shall be submitted to the commissioner and include the following:
10.1.1. A general listing of items to be removed from the residential property for disposal;
10.1.2. The methods used to wash hard surfaces;
10.1.3. The sequence of work activities;
10.1.4. Items requiring special handling for disposal;
10.1.5. An asbestos project design, prepared by a licensed asbestos project designer if asbestos containing materials are to be disturbed;
10.1.6. Any obvious safety hazards;
10.1.7. The methods used to handle cleaning effluents generated during remediation;
10.1.8. The beginning and ending dates of the remediation project, which may be modified only upon approval by the commissioner;
10.1.9. The identification of all methamphetamine remediation contractors and technicians engaged for the project;
10.1.10. The identification of any subcontractors to be used for any part of the remediation project; and
10.1.11. The identification of any waste disposal sites to be used.
10.2. Following review and approval of the preliminary remediation plan, the Commissioner shall issue a notice to proceed for the remediation project.
10.3. All applicable fees set forth in Table 64-92A of this rule shall be enclosed with a preliminary remediation plan.
W. Va. Code R. § 64-92-11 Final Remediation Report
11.1. A final remediation report shall be submitted to the commissioner within 10 business days of completion of remediation of residential property as documented on the Plan Review, and shall, at a minimum, contain the following:
11.1.1. The name, signature, copies of licenses (for all technicians involved), copies of training certificates (for all technicians involved) and license number of person who prepared the report;
11.1.2. The physical address of the property;
11.1.3. A summary of any work performed which deviated from or was not discussed in the approved preliminary remediation plan;
11.1.4. Documented use of waste-disposal dumpsters at all remediation projects; the use of trailers, truck beds and/or box trucks will be considered a violation of this rule;
11.1.5. Copies of waste manifests for all materials removed from the property, including a complete list with serial numbers (when applicable) of all items removed and disposed of from residential property;
11.1.6. Copies of clearance air monitoring sample results from a licensed asbestos clearance air monitor if asbestos containing materials were disturbed;
11.1.7. Copies of asbestos certificates for all asbestos contractors, workers, supervisors, and designers that performed any asbestos remediation;
11.1.8. Submission of final clearance analytical sample results by a third-party licensed technician, including the following:
11.1.8.a. Approved laboratory sample results with analysis for all samples collected, quality control plan for sampling of site, description of analytical methods used, and laboratory quality assurance and quality control plan;
11.1.8.b. A legible site drawing showing the location of all samples taken;
11.1.8.c. A photograph of each sample location cross-referenced to the laboratory results as identified on the site drawing, including a description of exact sample location with written and graphic description of sample locations;
11.1.9. A photograph of each room post decontamination;
11.1.10. A photograph of each item destroyed or rendered unusable on site;
11.1.11. Chain of custody forms with signatures for all samples collected;
11.1.12. A copy of the final remediation report checklist (available online at https://www.wvdhhr.org/rtia/pdf/Final%20Remediation%20Report%20Checklist(1).pdf) identifying the report page location for each required report component, along with a signed statement that all remediation work was performed in accordance with the provisions of this rule; and
11.1.13. Any other information requested by the commissioner.
11.2. If the submitted final remediation report is acceptable upon review, the commissioner shall issue a certificate of remediation completion within 20 business days of receipt of the report.
W. Va. Code R. § 64-92-12 Training Accreditation
12.1. The commissioner may accredit clandestine drug laboratory remediation courses provided to persons applying for licensure as a remediation technician in West Virginia.
12.2. Persons seeking clandestine drug laboratory remediation training course accreditation shall submit an application on forms approved by the commissioner (available online at https://www.wvdhhr.org/rtia/pdf/Training%20Provider%20Application%20Form.pdf) together with the fee set forth in Table 64-92A of this rule.
12.3. West Virginia accredited clandestine drug laboratory remediation initial training courses shall be a minimum of 16 hours in duration and shall include, at a minimum, the following:
12.3.1. Clandestine drug manufacturing methods;
12.3.2. The health effects and routes of chemical exposure;
12.3.3. Recognition of safety hazards;
12.3.4. Review of applicable OSHA requirements including:
12.3.4.a. The hazard communication program;
12.3.4.b. Blood borne pathogens;
12.3.4.c. Personal protective equipment; and
12.3.4.d. Confined space entry.
12.3.5. Sample collection and sampling protocol;
12.3.6. Hazardous and non-hazardous waste disposal;
12.3.7. Preliminary remediation plan preparation;
12.3.8. Final remediation report preparation;
12.3.9. Items requiring disposal;
12.3.10. Cleaning procedures for all surfaces;
12.3.11. Prevention of mold growth during and following remediation;
12.3.12. A review of this rule;
12.3.13. A review of 64CSR63;
12.3.14. Evaluation of heating, venting and air conditioning systems;
12.3.15. Legal liabilities; and
12.3.16. Types of insurance.
12.4. West Virginia accredited clandestine drug laboratory remediation refresher training courses shall be a minimum of four hours in duration and shall include, at a minimum, the following:
12.4.1. An overview of the initial training course curriculum;
12.4.2. A review of any recent changes in clandestine drug manufacturing procedures and in remediation technology; and
12.4.3. A review of any recent changes in state and federal regulatory requirements.
12.5. Training providers shall verify that each training class participant has successfully completed an initial training course within the previous year or has completed a refresher training course in the previous year and has had no lapse in certification since completing the initial training course.
12.6. All training course participants shall be provided with a manual of course materials.
12.7. All training course participants must take a 50 multiple choice questions examination and receive a minimum score of 80 percent for passage.
12.8. All training course participants who pass the examination shall be given a certificate containing the following:
12.8.1. The name of the person being certified;
12.8.2. A statement indicating that the person is certified as a clandestine drug laboratory remediation technician;
12.8.3. The name of the training provider business;
12.8.4. The dates of the training course;
12.8.5. The issue date of the certificate;
12.8.6. The expiration date of the certificate. All certificates expire one year from the date of issue; and
12.8.7. The typed name and signature of the lead course instructor.
12.9. Training providers accepted under this rule, shall notify the commissioner in writing 15 days prior to commencement of any training course.
12.10. The commissioner may audit any training courses conducted by any training provider accredited under this rule.
12.11. An accreditation expires one year from the last day of the month in which it was issued.
12.12. Initial training courses and refresher courses must be taught independently of each other.
W. Va. Code R. § 64-92-13 Inspections
The commissioner has the right to enter any clandestine drug laboratory remediation project and to conduct inspections to determine compliance with this rule.
W. Va. Code R. § 64-92-14 Penalties and enforcement
14.1. The commissioner may, depending upon the severity of the violation and upon the degree of health hazard created, suspend, or revoke the license of a clandestine drug laboratory remediation technician or contractor if the licensee:
14.1.1. Fraudulently or deceptively obtains or attempts to obtain a license;
14.1.2. Fails at any time to meet the qualifications for a license or to comply with the requirements of W. Va. Code §60A-11-1, et seq. or this rule;
14.1.3. Knowingly falsifies or attempts to falsify documents related to a clandestine drug laboratory remediation project or license; or
14.1.4. Fails to meet the applicable federal or state standard for remediation.
14.2. The Commissioner may investigate any suspected violations of this rule or of W. Va. Code §60A-11-1, et seq. All property owners of reported clandestine drug laboratories may be issued a compliance order. Upon the finding of a violation in connection with a clandestine drug laboratory property or remediation project the commissioner shall, depending upon the severity of the violation and upon the degree of health hazard created, initiate an appropriate enforcement action which may include the issuance of a cease and desist order directing that all work on the project be halted immediately. Posting of the cease and desist order on the project site constitutes notice of its contents to the property owner and all individuals working on the remediation project. Where practical, the commissioner shall deliver a copy of the order by certified mail, return receipt requested, to the property owner and to the contactor.
14.3. The commissioner may request the assistance of a law enforcement agency, county prosecutor office, or local health department in order to protect public health and safety and to prevent exposure to dangerous conditions in any residential property where a potential clandestine drug laboratory has been identified and prior to being properly remediated and certified as habitable by the commissioner.
14.4. The commissioner or his or her designee may post approved hazard signage on properties upon notification of the identification of a potential clandestine drug lab site and shall remain posted until such time as the property tests below levels allowed by this rule.
W. Va. Code R. § 64-92-15 Receipt and disbursement of license fees
Fees collected pursuant to this rule shall be deposited in accordance with the provisions of W. Va. Code §16-1-10, §16-1-11, and §16-1-12, to be used by the commissioner for purposes related to the implementation of this rule.
W. Va. Code R. § 64-92-16 Administrative due process
Those individuals adversely affected by the enforcement of this rule desiring a contested case hearing to determine any rights, duties, interests, or privileges shall do so in the manner prescribed by the Rules and Procedures for Contested Case Hearings and Declaratory Rulings, 64CSR1.
Table 64-92A Fee Schedule Clandestine Drug Laboratory Remediation Technician License $100 Clandestine Drug Laboratory Remediation Contractor License $300 Clandestine Drug Laboratory Preliminary Remediation Plan Review $100 Clandestine Drug Laboratory Remediation Training Provider Initial Accreditation $1,000 Clandestine Drug Laboratory Remediation Training Provider Annual Reaccreditation $500 64CSR92 64CSR92
Series 94 West Virginia Alzheimers Disease Registry
W. Va. Code R. § 64-94-1 General
1.1. Scope -- This procedural rule sets forth and establishes procedures governing the West Virginia Alzheimer’s Disease Registry as a central information database for policy and planning relative to Alzheimer's disease and related disorders, pursuant to the provisions of the West Virginia Administrative Procedures Act, 29A-3-1 et. seq.
1.2. Authority. -- W. Va. Code §16-5R-7.
1.3. Filing Date. -- November 27, 2007.
1.4. Effective Date.-- December 27, 2007.
1.5. Applicability. -- This rule applies to all hospitals, physicians, health care providers, health care facilities, Alzheimer’s disease/dementia special care units and programs, clinics or other similar units diagnosing or providing treatment or care for individuals who are diagnosed by a physician to have Alzheimer’s disease or a related disorder. These facilities include, but are not limited to, adult day care facilities, assisted living residences, behavioral health centers, nursing homes, and residential care communities.
1.6. Purpose. -- The West Virginia Alzheimer’s Disease Registry will provide a database to evaluate the incidence and prevalence of Alzheimer's disease and related disorders in West Virginia. It will provide information for policy planning purposes and provide non-identifying data to support research on Alzheimer's disease and related disorders.
W. Va. Code R. § 64-94-2 Definitions
2.1. Adult Day Care Facility - Any facility licensed as a medical adult day care center under WV Division of Health Legislative Rule, Medical Adult Day Care Center licensure, 64 CSR 2 or any day care program maintained and operated by a nursing home, hospital or other licensed health care facility.
2.2. Alzheimer’s Disease - A progressive, neurodegenerative disease leading to loss of mental functions such as memory and learning characterized by a loss of function and death of nerve cells in several areas of the brain. This disease is considered to be one of the most common forms of dementia.
2.3. Alzheimer’s Disease/Dementia Special Care Units and Programs - Any facility licensed as an Alzheimer’s Disease/Dementia special care unit or program under WV Division of Health Legislative Rule, Medical Adult Day Care Center licensure, 64 CSR 85 or any Alzheimer’s Disease/Dementia special care unit or program maintained and operated by a nursing home, hospital or other licensed health care facility.
2.4. Assisted Living Residence - Any facility licensed as an assisted living residence under WV Division of Health Legislative Rule, Assisted Living Residence licensure, 64 CSR 14.
2.5. Behavioral Health Centers - Any facility licensed as a behavioral health center under WV Division of Health Legislative Rule, Behavioral Health Center licensure, 64 CSR 11.
2.6. Dementia - A deterioration of intellectual function and other cognitive skills, leading to a decline in the ability to perform activities of daily living.
2.7. Director - The Director of the West Virginia Alzheimer’s Disease Registry or his or her designee.
2.8. Health care facility - Any hospital, nursing home, clinic, behavioral health center, adult medical day care facility, or other facility that provides health care or diagnostic services to individuals whether public or private.
2.9. Health care provider - Any physician, nurse, or other individual who provides medical, psychiatric, nursing, or other health care services of any kind to individuals.
2.10. Hospital - A facility licensed as a hospital under WV Division of Health Legislative Rule, Hospital Licensure, 64 CSR 12.
2.11. Medical Information - Data or other information regarding the history, examination, radiological or laboratory findings, diagnosis, treatment, or other clinical care for a person examined or treated for a suspected or actual illness.
2.12. Nursing Home - Any facility licensed as a nursing home under WV Legislative Rule, Nursing Home Licensure, 64 CSR 13, or any extended care facility operated in conjunction with a hospital.
2.13. Related Disorders - Dementias associated with vascular disease, mixed dementia and other medical conditions such as Parkinson’s disease and Huntington’s disease. These dementias also include senile dementia, presenile dementia, multi-infarct dementia, vascular dementia, alcoholic dementia, dementia with Lewy bodies, Creutzfeldt-Jakob disease, frontotemporal dementia, and medical diagnoses with dementia.
2.14. Residential Care Community - Any facility licensed as a residential care community under WV Division of Health Legislative Rule, Residential Care Community licensure, 64 CSR 75.
2.15. Registry - West Virginia Alzheimer’s Disease Registry is a central information database concerning Alzheimer’s disease and related disorders maintained by West Virginia University.
2.16. Board of Governors - West Virginia University Board of Governors.
W. Va. Code R. § 64-94-3 Purpose: Required Reporting of Alzheimer’s disease and related disorders
3.1. The Board of Governors shall establish the Registry and delegate to the Vice-President for Health Sciences at West Virginia University or their designee the responsibility for developing specific protocols for the reporting of Alzheimer’s disease and related disorders to the Registry. The protocols shall include any information to be reported under this rule and any additional relevant information determined to be necessary for adequate reporting. All protocols must be approved by the West Virginia University Institutional Review Board.
3.2. The reports required by this rule shall be reported electronically or in paper format on forms available from or provided by the Registry.
W. Va. Code R. § 64-94-4 Registry Contents
4.1. Information to be reported. Reports from health care providers and facilities, as defined in section 2 of this rule shall include the individual’s:
4.1.a. Last name, first name and middle initial;
4.1.b. Birth date;
4.1.c. Gender;
4.1.d. Last four digits of the Social security number;
4.1.e. Maiden name( if female);
4.1.f. Race/ethnicity;
4.1.g. Address, including street, city, county, and zip code;
4.1.h. Contact information including secondary contacts;
4.1.i. Brief medical history;
4.1.j. History of Alzheimer’s disease and related disorders;
4.1.k. Physician’s name;
4.1.l. Physician’s contact information including address, phone, fax numbers, or email; and
4.1.m. Other information considered relevant for policy and planning relative to Alzheimer's disease and related disorders.
4.2. Content and design of forms. The content and design of all forms for the Registry shall be consistent with the minimum information necessary to maintain the registry, pursuant to the provisions of W. Va. Code 16-5R-7(a).
4.3. Content and design of reports. The content and design of all reports for the Registry shall provide the most relevant and complete summary statistics and information required to advise policy development, pursuant to the provisions of W. Va. Code §16-5R-7(c).
W. Va. Code R. § 64-94-5 Standard Operating Procedures
5.1. All aspects of data collection, management, and maintenance shall be governed by written standard operating procedures developed by the Registry.
W. Va. Code R. § 64-94-6 Data Management
6.1. Registry data shall be managed in compliance with standard data management procedures.
W. Va. Code R. § 64-94-7 Regulatory Compliance
7.1. The Registry shall comply with all applicable Department of Health and Human Resources requirements and rules.
W. Va. Code R. § 64-94-8 Persons and Facilities, Required to Report
8.1. Health care Providers and Facilities. All health care providers and facilities, as defined in section 2 of this rule, that diagnose Alzheimer’s disease or a related disorder or provide treatment or care for an individual who is diagnosed by a physician to have Alzheimer’s disease or a related disorder shall provide a report of each case of the disease or condition as required by this rule.
W. Va. Code R. § 64-94-9 Distribution of Rule
9.1. The Registry shall distribute this rule to licensed health care providers or facilities, as defined in section 2 of this rule, which have a duty to report pursuant to the provisions of this rule. Local health departments may copy and distribute this rule to local health care providers or facilities, as defined in section 2 of this rule, at no cost. The rule shall also be available online from the Registry at www.WVADR.hsc.wvu.edu.
W. Va. Code R. § 64-94-10 Confidential Information, Utilization of Information, and Permitted Disclosures of Information
10.1. Confidential Information: Any information collected and maintained pursuant to this rule by the Registry which identifies an individual as having Alzheimer’s disease or a related disorder is “confidential information” and exempt from disclosure to third parties, pursuant to the provisions of all applicable state and federal laws, unless the disclosure is permitted pursuant to the provisions of subsection 10.3 of this section.
10.2. Use of non-identifying information:
10.2.1. The Registry may disclose non-identifying information for research purposes only.
10.3. Permitted Disclosures of Confidential Information:
10.3.1. Registry may release “confidential information” to the following:
10.3.1.a. The individual diagnosed with Alzheimer’s disease or a related disorder;
10.3.1.b. The individual’s representative, who has the legal authority to access the individual’s confidential information by virtue of a lawful written authorization or legal instrument or by virtue of an order from a court of competent jurisdiction;
10.3.1.c. A physician or other health care provider, if the request for confidential information is for the purpose of a medical evaluation or treatment of the individual;
10.3.1.d. Any individual or entity which provides the Registry with a lawful written authorization for the disclosure of confidential information from the individual diagnosed with Alzheimer’s disease or related disorder or that individual’s representative; or
10.3.1.e. Any individual or entity which provides the Registry with an order from a court of competent jurisdiction ordering the disclosure of confidential information.
10.4. In order to ensure patient confidentiality, patients will be assigned a unique identifying number. All patient information shall be stored as identified information and information with identification removed in two linked datasets on a secure, encrypted, password-protected database server. The Director of the Registry and his or her designee shall have the only means of linking the identified information and the information with identification removed.
W. Va. Code R. § 64-94-11 Communication
11.1. Communication by the Registry with individuals, individual’s representatives, and health care providers or facilities, as defined in section 2 of this rule, shall be made directly via U.S. mail, telephone, or e-mail to notify individuals and individuals’ representatives about inclusion in the Registry and, if requested, to advise about research opportunities and to convey disease-related information.
W. Va. Code R. § 64-94-12 Registry Director
12.1. The Board of Governors shall delegate to the President of West Virginia University or his or her designee the responsibility for appointment of the Director of the Registry.
W. Va. Code R. § 64-94-13 Registry Advisory Board
13.1. The Board of Governors shall delegate to the President of West Virginia University or his or her designee the responsibility for the appointment of an Advisory Board to the Registry.
13.1.1. The Advisory Board shall make recommendations to the Director about the implementation, coordination and oversight of the Registry.
13.1.2. The Advisory Board shall be comprised of, but not limited to, representatives from The Blanchette Rockefeller Neurosciences Institute, The Institute on Aging, West Virginia University, Marshall University, West Virginia Department of Health and Human Resources, and representatives of public and private entities and organizations and other individuals involved in Alzheimer’s disease and related disorders. These shall include, but not be limited to, the Alzheimer’s Association, West Virginia chapter, West Virginia State Medical Association, West Virginia Health Care Association, AARP (American Association of Retired Persons) West Virginia, West Virginia chapter of the National Association of Social Workers and other stakeholders as well as members of the community including a caregiver of a person with Alzheimer’s disease or a related disorder.
64CSR94
64CSR94
Series 95 Immunization Requirements and Recommendations for Children Attending School and Enrolled in State-Regulated Child Care
W. Va. Code R. § 64-95-1 General
1.1. Scope. -- This rule establishes dosages and interval schedules for vaccines mandated by law for admission to a public, private, or parochial school in this state, or a state-regulated child care center. Additionally, the rule includes additional recommendations for immunizations to promote public health. Finally, this rule establishes the process for requesting a medical exemption from compulsory immunizations required of children attending a public, private, or parochial school in this state, or a state-regulated child care center.
1.2. Authority. -- Generally, the Secretary of the Department of Health and Human Resources is authorized to “adopt rules . . . to obstruct and prevent the introduction or spread of . . . communicable or infectious diseases into or within the state, and the [State Health Officer] shall have the power to enforce these regulations . . .” W. Va. Code §16-3-1. The Commissioner is authorized to require additional immunizations for public health purposes. W. Va. Code §5-16-9(i). Furthermore, the Secretary of the Department of Health and Human Resources is generally authorized to propose legislative rules necessary and proper to effectuate the purposes of Chapter 16. W. Va. Code §16-1-4.
More specifically, a child may not be admitted or received in any of the schools of the state or a state-regulated child care center until he or she has been appropriately immunized against chickenpox, hepatitis-b, measles, meningitis, mumps, diphtheria, polio, rubella, tetanus and whooping cough or produces a certificate from the Commissioner granting the child or person, an exemption from the compulsory immunization requirements. W. Va. Code §16-3-4(c). Although, state law provides for the immunizations required of children attending the schools of the state or state-regulated child care centers, W. Va. Code §16-3-4, does not include specific guidance regarding the manner in which compulsory immunization must be administered.
The Commissioner has the authority to provide information or guidance to the public regarding the agency’s interpretations, policy or opinions upon the law enforced or administered by the Commissioner. W. Va. Code §29A-1-2. This rule is not intended to be determinative of any issue affecting constitutional, statutory or common law rights, privileges or interests. Instead, the rule will provide the public with information and clearly define the requirements and recommendations for immunizations for all children enrolled in a public, private, or parochial school in this state, or a state-regulated child care center.
1.3. Filing Date. -- August 3, 2015.
1.4. Effective Date. -- September 3, 2015.
1.5. Summary. -- The Bureau for Public Health is promulgating this interpretive rule to set forth the Bureau’s interpretation of the provisions of W. Va. Code §16-3-4, which provides that “[n]o child or person may be admitted or received in any of the schools of the state or a state-regulated child care center until he or she has been immunized against chickenpox, hepatitis-b, measles, meningitis, mumps, diphtheria, polio, rubella, tetanus and whooping cough or produces a certificate from the Commissioner granting the child or person an exemption from the compulsory immunization requirements of this section.” The Bureau interprets the provisions of W. Va. Code §16-3-4, to incorporate the most current recommendations issued by the U.S. Department of Health and Human Services, Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP), the American Academy of Family Physicians (AAFP) and the Centers for Disease Control and Prevention (CDC).
1.6. Applicability -- This rule applies to all children enrolled in a public, private, or parochial school in this state, or a state-regulated child care center.
1.7. Purpose -- The purpose of this rule is to clearly define the requirements and recommendations for immunizations for all children enrolled in a public, private, or parochial school in this state, or a state-regulated child care center. Additionally, the rule series establishes the procedure for granting, renewing, conditioning, denying, suspending or revoking a request for a medical exemption from the compulsory immunization requirements of W. Va. Code §16-3-4.
1.8. Background -- The Legislature has granted the Commissioner/State Health Officer extensive powers to protect the public health, i.e., restricting the liberty of persons through measures such as quarantine, enter upon and inspecting private property, asserting authority of any epidemic or endemic conditions, compelling physical examinations and compelling vaccination. Indeed, W. Va. Code §16-3-1, provides, “the state board of health [now the Secretary] may adopt rules and regulations to obstruct and prevent the introduction or spread of smallpox or other communicable or infectious diseases into or within the State[.]”
The Legislature has declared as the public policy of this State:
1.8.1. That early immunization for preventable diseases represents one of the most cost-effective means of disease prevention.
1.8.2. the savings which can be realized from immunization, compared to the cost of health care necessary to treat the illness and lost productivity, are substantial. Immunization of children at an early age serves as a preventative measure both in time and money and is essential to maintain our children's health and well-being.
1.8.3. the costs of childhood immunizations should not be allowed to preclude the benefits available from a comprehensive, medically supervised child immunization service.
1.8.4. the federal government has established goals that require ninety percent of all children to be immunized by age two and provided funding to allow uninsured children to meet this goal. W. Va. Code §16-3-5(a)
Consistent with this expressed public policy, the Legislature has mandated compulsory immunization for all children enrolled in a public, private, or parochial school in this state, or a state-regulated child care center. W. Va. Code §16-3-4. However, the legislature only mandated particular immunizations without providing any further guidance. This rule is intended to provide specific guidance with regard to dosage and interval schedules based upon the most current recommendations issued by the U.S. Department of Health and Human Services, Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP), the American Academy of Family Physicians (AAFP) and the Centers for Disease Control and Prevention (CDC).
Optimal response to a vaccine depends on multiple factors, including the type of vaccine, age of the recipient, and immune status of the recipient. Recommendations for the age at which vaccines are administered are influenced by age-specific risks for disease, age-specific risks for complications, age-specific responses to vaccination, and potential interference with the immune response by passively transferred maternal antibodies. Vaccines are recommended for members of the youngest age group at risk for experiencing the disease for which efficacy and safety have been demonstrated.
Certain products, including inactivated vaccines, toxoids, recombinant subunit vaccines, polysaccharide conjugate vaccines, and live vaccines, require ≥2 doses to elicit an adequate antibody response. Tetanus and diphtheria toxoids require booster doses to maintain protective antibody concentrations. Unconjugated polysaccharide vaccines do not induce T-cell memory, and additional doses (although they elicit the same or a lower antibody concentration) might increase the level of protection. Conjugation with a protein carrier improves the effectiveness of polysaccharide vaccines by inducing T-lymphocyte–dependent immunologic function. Many vaccines that stimulate both cell-mediated immunity and neutralizing antibodies (e.g., live, attenuated virusvaccines) usually can induce prolonged immunity, even if antibody titers decline over time. Subsequent exposure to such viruses usually results in a rapid anamnestic antibody response without viremia.
Approximately 90%–95% of recipients of a single dose of certain live vaccines administered by injection at the recommended age (i.e., measles, rubella, and yellow fever vaccines) develop protective antibodies, generally within 14 days of the dose. For varicella and mumps vaccines, 80%–85% of vaccinees are protected after a single dose. However, because a limited proportion (5%–15%) of measles, mumps, and rubella (MMR) or varicella vaccinees fail to respond to 1 dose, a second dose is recommended to provide another opportunity to develop immunity. Of those who do not respond to the first dose of MMR or varicella vaccine, 97%–99% respond to a second dose.
The recommended immunization schedule for Persons Aged 0 Through 18 Years childhood immunization is the schedule jointly approved by the Advisory Committee on Immunization Practices, the American Academy of Pediatrics, and the American Academy of Family Physicians. This schedule is issued annually and can be found at http://www.cdc.gov/vaccines.
1.9. Revising immunization requirements. -- Upon a finding of the existence of an emergency that may adversely affect the public health and safety, the Commissioner may modify the immunization requirements of this rule, to remove, modify or add a vaccine, in accordance with the requirements of the State Administrative Procedures Act (W. Va. Code §§29A-3-1 et. seq.).
W. Va. Code R. § 64-95-2 Definitions
2.1. “Bureau” means the Bureau for Public Health in the Department of Health and Human Resources.
2.2. “Child” or “Children” means any person between the ages of birth and eighteen years or up to twenty-one years of age when that person is attending school.
2.3. “Commissioner” means the Commissioner of the Bureau for Public Health, or his or her designee.
2.4. “Contraindication” means a medical condition which renders an immunization improper for a particular individual. Contraindications for each vaccine are found in statements written and published by the Advisory Committee on Immunization Practices (ACIP) as Recommendations of the Immunization Practices Advisory Committee and in Vaccine Information Statements (VIS) from the Centers for Disease Control and Prevention (CDC). The recommendations of the ACIP and VIS regarding contraindications can be found at http://www.cdc.gov/vaccines.
2.5. “Delinquent” means lacking age appropriate immunization(s) which are required to have been completed prior to school entry.
2.6. “Exemption” means an exemption for the compulsory immunization requirements of W. Va. Code §16-3-4 and 64 C.S.R. 95.
2.7. “Immunization Officer” means the physician appointed and employed by the Commissioner to make a determination on an application for an exemption to the compulsory immunization requirements of W. Va. Code §16-3-4, on a statewide basis.
2.8. “Local Health Officer” means the physician who supervises and directs the medical activities of a local health department and is appointed by the local board of health with approval from the Commissioner.
2.9. “Physician” means the child’s personal licensed physician.
2.10. “Precaution” means a condition defined under the current standards of immunization practice that might increase the chance or severity of an adverse vaccine reaction or compromise the ability of the vaccine to produce immunity.
2.11. “State Health Officer” means the person appointed to serve as Commissioner and State Health Officer of the Bureau.
2.12. “Student” means any child who enters into a school building housing kindergarten through twelfth grade to attend classes or programs or to participate in extracurricular activities taking place in a school building, on school grounds or at a place where the school conducts extracurricular activities and includes children entering for preschool programs as well as children in grades kindergarten through twelfth grade and children who transfer into a West Virginia School from another state or who transfer from being home schooled or from a private or alternative school.
W. Va. Code R. § 64-95-3 Interpretive Rule
As it is the intent of W. Va.Code §16-3-4, to provide for the compulsory immunization of all children enrolled in a public, private, or parochial school in this state, or a state-regulated child care center, and as it is consistent with the Commissioner’s authority to (1) enforce the public health laws of this State; and (2) require additional immunizations for public health purposes, the Bureau for Public Health interprets W. Va.Code §16-3-4, to include:
3.1. Dosage and interval schedules based upon the most current recommendations issued by the U.S. Department of Health and Human Services, Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP), the American Academy of Family Physicians (AAFP) and the Centers for Disease Control and Prevention (CDC), for the following immunizations:
3.1.a. Diphtheria – the specific dosage and interval schedules are contained in section 4;
3.1.b. Hepatitis B – the specific dosage and interval schedules are contained in section 5;
3.1.c. Mumps – the specific dosage and interval schedules are contained in section 7;
3.1.d. Pertussis (Whooping Cough) – the specific dosage and interval schedules are contained in section 4;
3.1.e. Poliomyeltis (Polio) – the specific dosage and interval schedules are contained in section 8;
3.1.f. Rubella– the specific dosage and interval schedules are contained in section 9 of this rule;
3.1.g. Rubeola (Measles) – the specific dosage and interval schedules are contained in section 6;
3.1.h. Tetanus– the specific dosage and interval schedules are contained in section 4;
3.1.i. Varicella (Chickenpox) – the specific dosage and interval schedules are contained in section 10; and
3.1.j. Meningococcal (meningitis) – the specific dosage and interval schedules are contained in section 11;
3.2. Dosage and interval schedules based upon the most current recommendations issued by the U.S. Department of Health and Human Services, Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP), the American Academy of Family Physicians (AAFP) and the Centers for Disease Control and Prevention (CDC), for children entering state-regulated child care centers as contained in section 12;
3.3. Recommended, but not required, vaccines for children as contained in section 13;
3.4. Criteria for determining compliance with compulsory immunization requirements of W. Va.Code §16-3-4, as contained in section 14;
3.5. Methods for documenting proof of immunity as contained in section 15;
3.6. Determining eligibility for a medical exemption from the compulsory immunization requirements of W. Va.Code §16-3-4, as contained in section 16; and
3.7. The process for requesting a medical exemption from the compulsory immunization requirements of W. Va.Code §16-3-4, and process for making a determination as to whether a there is sufficient medical evidence that an immunization is contraindicated or there exists a specific precaution to a particular vaccine, as contained in section 17;
W. Va. Code R. § 64-95-4 Dosage and Interval Schedule for Diphtheria, Pertussis And Tetanus Vaccines
4.1. Prior to being admitted to school, a child must show proof that he or she has received a minimum of four doses of Diphtheria, Tetanus, Acellular Pertussis (DTaP) vaccine, with the fourth dose having been received on or after the child’s fourth birthday and prior to school entry.
4.2. The interval between the third and fourth dose shall be at least six (6) months.
4.3. A fifth dose of DTaP between the ages of 4 and 6 is only necessary if the fourth dose was given either before the child’s fourth birthday or if the interval between the third and fourth doses was less than six months.
4.4. A child between the ages of 11 and 12 must receive one dose of Tetanus, Diphtheria and acellular Pertussis vaccine (Tdap). Tdap can be administered regardless of the interval since the last tetanus and diphtheria toxoid containing vaccine (Td). This includes a child/student transferring into school or newly joining school who has not had the DTaP or Tdap prior. Inadvertent doses of Tdap given between the ages of 7 and 10 do not count as the 11-12 year old dose except as provided in subsection 4.6.
4.5. A student who becomes pregnant may receive one dose of Tdap during the pregnancy (preferred during 27-36 weeks gestation) regardless of the number of years since a prior Tdap or Td vaccination.
4.6. A student aged 7 – 10 years old who is not fully immunized with the childhood DTaP vaccine series must receive the Tdap vaccine as the first dose in the catch-up series and if additional doses are needed, the student should receive the Td vaccine. A child who receives the Tdap vaccine, is specifically excluded from the requirements of subsection 4.4.
W. Va. Code R. § 64-95-5 Dosage and Interval Schedule for Hepatitis B Vaccine
5.1. Prior to entering school, a child must show proof that he or she has received at least three doses of HEPATITIS B vaccine with at least one dose having been given on or after six months of age. The first and second dose must be at least four (4) weeks apart. The second and third doses should be separated by at least eight (8) weeks. Additionally, the third dose should be at least sixteen (16) weeks after the first dose.
5.2. An unvaccinated student must complete a three (3) dose series. However, a two (2) dose series (with doses separated by a minimum of four (4) months) using the adult formulation Recombivax HB which is licensed for children aged 11 -15 years, is an acceptable alternative to the three dose requirement.
5.3. Occurrence of prior disease may be used as evidence of immunity.
5.4. A student may attend school and participate in extracurricular activities after he or she has received the first of the series of Hepatitis B vaccinations. The series must be completed within seven (7) months of the date of entry or the student will be excluded from school and all extracurricular activities until the student completes the Hepatitis B series. It is the responsibility of the student and his or her parents or legal guardians to ensure the timely completion of the Hepatitis B series and submit the acceptable proof to the school authorities.
W. Va. Code R. § 64-95-6 Dosage and Interval Schedule for Rubeola (Measles) Vaccine
6.1. Prior to entering school, a child must show proof that he or she has received two doses of Rubeola (Measles) vaccine, the first dose on or after the first birthday and the second dose no less than four (4) weeks after the first dose. Alternatively, immunity may be proven through laboratory testing. Results of laboratory that prove immunity must be presented to the Local Health Officer for review and approval before the child may be admitted to school.
6.2. Occurrence of prior disease may be used as evidence of immunity.
W. Va. Code R. § 64-95-7 Dosage and Interval Schedule for Mumps Vaccine
7.1. Prior to entering school, a child must show proof that he or she has received at least two doses of Mumps vaccine, the first dose on or after the first birthday and the second dose no less than four (4) weeks after the first dose. Alternately, immunity may be shown through laboratory testing. Results of laboratory that prove immunity must be presented to the Local Health Officer for review and approval before the child may be admitted to school.
7.2. Occurrence of prior disease may be used as evidence of immunity.
W. Va. Code R. § 64-95-8 Dosage and Interval Schedule for the Polio (IPV) Vaccine
8.1. Four doses of trivalent inactivated polio vaccine (IPV) are recommended for routine immunization of all children with the fourth dose given on or after the child’s fourth birthday and at least a six (6) month interval from the third dose. Prior being admitted to school, a child must show proof that he or she has received a minimum of three doses of IPV with the last dose given on or after the child’s fourth birthday and at least six months after the second dose.
8.2. A child who has not received the recommended doses of IPV should receive a minimum of three doses, with four (4) weeks between dose one and two, and six (6) months between doses two and three. Additionally, dose three must be received on or after the child’s fourth birthday.
8.3. A student may attend school and participate in extracurricular activities after he or she has received the first of the series of IPV vaccinations. The series must be completed within seven (7) months of the date of entry or the student will be removed from school and all extracurricular activities until the IPV series is complete. It is the responsibility of the student and his or her parents or legal guardians to ensure the timely completion of the IPV series and submit the acceptable proof to the school authorities.
8.4. In the alternative, a child who has had three or more doses of an oral, live attenuated version of the Polio Vaccine (OPV), or a combination of OPV and IPV, the last dose of which was given on or after the child’s fourth birthday with at least a six (6) month separation between the second and third dose, are in compliance with this section. Otherwise, subsection 8.2., applies but doses of OPV may be substituted in the record for IPV.
W. Va. Code R. § 64-95-9 Dosage and Interval Schedule for the Rubella Vaccine
9.1. Prior to entering school, a child must show proof that he or she has received at least two doses of Rubella vaccine, the first dose on or after the first birthday and the second dose no less than one month after the first dose. Alternately, immunity may be proven through laboratory testing. Results of laboratory testing that prove immunity must be presented to the Local Health Officer for review and approval before the child may be admitted to school.
9.2. Occurrence of prior disease may be used as evidence of immunity.
W. Va. Code R. § 64-95-10 Dosage and Interval Schedule for the Varicella (Chickenpox) Vaccine
10.1. Prior to a child age 4 to 12 years entering school, he or she must show proof of having received two doses of Varicella (Chickenpox) vaccine, the first dose on or after the first birthday and the second dose no less than three month after the first.
10.2. A child age 13 years and older who is without proof of immunity, must receive two doses of the Varicella vaccine with at least 4 weeks between shots.
10.3. A student who has received only one dose of the Varicella vaccine is required to obtain a second dose. For a child between the ages of 4 to 12 years, the second dose must be given at least 28 days after the first dose.
10.4. Alternately, immunity may be shown through the written or verbal statement of a parent or legal guardian attesting to the fact of their child’s history of chickenpox accompanied by laboratory testing showing immunity, if requested.
10.5. A student may attend school and participate in extracurricular activities after he or she has received the first of the series of Varicella vaccinations. The series must be completed within three (3) months of the date of entry for a child between ages 4 to 12 years and within one (1) month for a child 13 or older, or the student must be removed from school and all extracurricular activities until such time as the Varicella series is complete or laboratory evidence of immunity is supplied. It is the responsibility of the student and his or her parents or legal guardian to ensure the timely completion of the Varicella series or laboratory testing and submit acceptable proof to the school authorities.
W. Va. Code R. § 64-95-11 Dosage and Interval Schedule for the Meningococcal (MCV4) Vaccine
11.1. A student ages 11 or 12 must show proof of Meningococcal vaccination prior to entry into the 7th grade. Students will require a booster shot at age 16 or older, and will need to show proof of the MCV4 booster prior to entry into the 12th grade.
11.2. A student who is newly entering the school system at age 13, 14 or 15, and who has not been previously vaccinated with MCV4 must receive the MCV4 vaccination and must also show proof of a booster shot on or after age 16 and prior to entry into the 12th grade.
11.3. A student who is newly entering the school system at age 16 or older and who has not been previously vaccinated with MCV4 must receive a MCV4 vaccination and will not be required to show proof of a booster prior to entry into the 12th grade.
W. Va. Code R. § 64-95-12 Applicability of Dosage and Interval Schedules to Pre-School Students
The dosage and interval schedules contained in sections 4 through 11 apply to children entering a state-regulated child care center and preschool children who enter a school building housing other children in grades kindergarten through twelfth, to the extent that they are age appropriate in accordance with those immunization schedules.
W. Va. Code R. § 64-95-13 Recommended Vaccinations
The following vaccines are recommended, but not required, for all children attending a public, private, or parochial school in this state, or a state-regulated child care center:
13.1. Influenza Vaccine.
13.1.a. A child aged six months or older should be vaccinated annually against influenza. Children from six to twenty-three months are at substantially increased risk for influenza-related hospitalizations and children ages twenty-four to fifty-nine months are at increased risk for influenza-related clinic and emergency room visits. Children and school personnel with certain medical conditions and school personnel who are older are at increased risks of influenza complications and death.
13.1.b. An annual flu vaccine is recommended in accordance with annually released U.S. Department of Health and Human Services, Advisory Committee on Immunization Practices recommendations.
13.2. Human Papillomavirus Vaccine - HPV Vaccine. Most human papillomavirus (HPV) infections are inapparent clinically. However, HPVs can cause benign though disfiguring epithelial proliferation of the skin and mucous membranes and are associated with several cancers. The HPV vaccines are the only available vaccine that protects against certain cancers. The American Academy of Pediatrics recommends that routine vaccination of females with the HPV2 or HPV4 starting at age 11 or 12, though the vaccine has been approved starting at age 9. The vaccine is a three dose series with a minimum of one month between doses one (1) and two (2) and dose three (3) given six months after dose one (1). The vaccine for females is approved from age 9 to 26. The vaccine is also recommended for males from age 13 to 26 with the same dosing schedule. HPV4 is the only HPV vaccine approved for males.
13.3. Other Vaccinations. Other vaccines recommended for various high risk populations in the school setting may be found on the immunization schedules jointly approved by the Advisory Committee on Immunization Practices, the American Academy of Pediatrics, and the American Academy of Family Physicians at www.cdc.gov by searching under “Immunization Schedules”.
W. Va. Code R. § 64-95-14 Compliance with the Law
14.1. A child is considered to be in compliance with the law requiring compulsory immunizations and this rule, when the child has a complete certificate of immunization or similar medical record of immunizations, or when immunization is contraindicated or there exists a specific precaution to a particular vaccine.
14.2. If a child has been granted an exemption from receiving one or more vaccinations, the certificate of immunization must indicate the vaccine(s) for which the child is exempted, the reason for the exemption, and whether or not the reason for the exemption is permanent or temporary. If the exemption is temporary, it must be re-evaluated annually unless a longer period of time is indicated by the child’s treating physician. A temporary exemption may not exceed a period of 24 months before re-evaluation.
14.3. A student who does not have a completed certificate of immunization or other similar medical record of immunizations must show proof that he or she has received at least one dose of each of the required vaccines in order to be provisionally enrolled in school.
14.3.a. Provisional enrollment may continue for the time medically necessary to complete the missing vaccinations.
14.3.b. At no time should the provisional enrollment period exceed 8 months from school entry, the time medically necessary to complete all required childhood vaccine series under the standard catch up schedule.
14.3.c. After attending school for the provisional enrollment time period, all provisionally enrolled students must show proof to the school that they have completed all of the required immunizations or laboratory evidence of immunity.
14.4. A child who is delinquent for any required vaccination, or who has exceeded the provisional enrollment period, will be considered not to be in compliance with the law and this rule, and will be suspended from attending school until the appropriate vaccine(s) or laboratory evidence is received and the records are amended.
W. Va. Code R. § 64-95-15 Proof of Immunity
15.1. Proof that a child has received the immunizations required by law, in the correct number and spacing of doses, shall be recorded on a completed document, such as a certificate of immunization, for all students.
15.2. A Certificate of Immunization form has been developed by the West Virginia Department of Health and Human Resources, Bureau for Public Health, Immunization Program. This form is available to appropriate health care providers electronically through participation in the West Virginia Statewide Immunization Information System (WVSIIS) - -http://www.dhhr.wv.gov/oeps/immunization/providers/Pages/WVSIIS.aspx. The form is also available from:
ATTN: WVSIIS
Bureau for Public Health Immunization Program 350 Capitol Street, Room 125 Charleston, WV 25301
15.3. The documentary evidence of immunizations must contain the day, month and year of each vaccine received by the child or sufficient information of the time interval between doses to enable verification that the minimum intervals required or suggested by this rule have been observed.
15.4. Proof of prior measles, mumps, rubella, varicella or hepatitis B disease being used in lieu of vaccination, requires a document signed by a physician indicating, at a minimum, the name of the patient, the date of the illness and laboratory evidence of immunity in the form of titers for measles, mumps and rubella and a Hepatitis B panel for Hepatitis B. If the historical disease diagnosis is in question, current laboratory evidence of immunity may be required.
W. Va. Code R. § 64-95-16 Eligibility for a Medical Exemption
The Immunization Officer must determine that the child, on whose behalf his or her physician has made a request for an exemption, is eligible for and issue an exemption, upon sufficient medical evidence that an immunization is contraindicated or there exists a specific precaution to a particular vaccine.
W. Va. Code R. § 64-95-17 Eligibility Process
17.1. Request. A physician must complete a “Request for Medical Exemption from Compulsory Immunization” form available at the Department of Health and Human Resources Medical Exemption Resource Center website. The form may be accessed at the following link: http://www.dhhr.wv.gov/oeps/immunization/requirements/Documents/WV_Med_Exempt_Request_Form%20_11.20.13.pdf. The application must include:
17.1.a. The name of the child for whom the request is made;
17.1.b. The date of birth of child for whom the request is made;
17.1.c. The name of the school the child attends and the county where the school is located;
17.1.d. The name(s) of the child’s parent or guardian;
17.1.e. The address of the child’s parent or guardian;
17.1.f. The name, address and telephone number of the physician making the request;
17.1.g. The specific vaccine or vaccines for which an exemption is requested;
17.1.h. An explanation of the medical contraindication or precaution relied upon to make the request;
17.1.i. Whether the request is for a permanent or temporary exemption;
17.1.j. Certification by the physician that the physical condition of the child is such that immunization is contraindicated or there exists a specific precaution to a particular vaccine. This certification must be supported by medical signs and laboratory findings; and
17.1.k. If a temporary exemption is indicated, the physician’s opinion as to the date or period of time after which the exemption should be reevaluated.
17.2. Evidence. In general, the physician, on behalf of the child, has the burden of proving that an exemption is necessary. This means that the physician must furnish medical and other evidence that the Immunization Officer can use to reach conclusions about the need for an exemption.
17.2.a. Evidence is anything the physician submits to the Immunization Officer or that the Immunization Officer obtains that relates to the request for an exemption. This includes, but is not limited to:
17.2.a.1. Objective medical evidence, that is, medical signs and laboratory results; and
17.2.a.2. Other evidence from medical sources, such as medical history, opinions, and statements about treatment the child has received.
17.2.b. Physician’s responsibility.
17.2.b.1. The physician must provide medical evidence showing that an exemption is necessary. The Immunization Officer will make reasonable efforts to notify the physician of any deficiencies in the request but it remains the responsibility of the physician to assure that the request is complete; and
17.2.b.2. The physician must inform the child’s parent or guardian of the process for obtaining an exemption and the status of the request.
17.2.c. Immunization Officer’s responsibility. Before making a determination as to whether an exemption should be granted, the Immunization Officer will review the evidence obtained from the physician. The Immunization Officer will make every reasonable effort to obtain relevant medical evidence from the physician.
17.2.d. Every reasonable effort means that the Immunization Officer will make an initial request for evidence from the physician and, at any time between 10 and 20 calendar days after the initial request, if the evidence has not been received, the Immunization Officer will make one follow-up request to obtain the medical evidence necessary to make a determination. The physician will have a minimum of 10 calendar days from the date of the follow-up request to reply, unless the Immunization Officer’s experience with that physician indicates that a longer period is advisable in a particular case.
17.3. Preliminary Exemption. The Immunization Officer may grant a child a preliminary exemption if it appears that there is a substantial likelihood that the child will be eligible for a medical exemption, but that the medical evidence sufficient to support a medical exemption cannot be timely developed through no fault of the physician.
17.3.a. How a preliminary exemption is obtained. A preliminary exemption may be requested by a physician or may be granted without a request, by the Immunization Officer if the Immunization Officer finds that the medical evidence is insufficient to make a determination.
17.3.b. Findings necessary for preliminary exemption. In order to grant an applicant a preliminary exemption, the Immunization Officer must find that:
17.3.b.1. Sufficient medical evidence is not available;
17.3.b.2. Additional relevant medical evidence is obtainable;
17.3.b.3. Additional effort must be made to obtain relevant medical evidence;
17.3.b.4. It is not the fault of the physician that sufficient medical evidence is not available;
17.3.b.5. Because of the delay in obtaining relevant medical evidence, the child will miss a significant number of educational days if the preliminary exemption is not granted;
17.3.b.6. It is likely that little or no harm will result to the public if the preliminary exemption is granted; and
17.3.b.7. There is a substantial likelihood that the child will be eligible for an exemption once the relevant medical evidence is obtained.
17.3.c. Duration of a preliminary exemption. If a preliminary exemption is granted by the Immunization Officer, the preliminary exemption will remain in effect until the Immunization Officer makes a determination on the application for an exemption.
17.4. Determination of Eligibility. The Immunization Officer must determine eligibility for an exemption in accordance with the eligibility standard specified in section 16 and grant the certificate of exemption to any applicant determined eligible.
17.4.a. After the Immunization Officer reviews all of the evidence relevant to the application, including medical opinions, the Immunization Officer will make findings about what the evidence shows. In some situations, the Immunization Officer may not be able to make these findings because the evidence in the case record is insufficient or inconsistent. Evidence will be considered to be insufficient when it does not contain all the information needed to make a determination or decision. Evidence is considered to be inconsistent when it conflicts with other evidence, contains an internal conflict, is ambiguous, or when the medical evidence does not appear to be based on medically acceptable clinical or laboratory diagnostic techniques. If the evidence in the record is insufficient or inconsistent, the Immunization Officer may need to take additional actions, as explained in subdivisions c. and d. of this subsection.
17.4.b. If all of the evidence received by the Immunization Officer, including all medical opinion(s), is consistent and there is sufficient evidence for a determination of whether to grant an exemption, the Immunization Officer will make a determination or decision based on that evidence.
17.4.c. If any of the evidence in the record, including any medical opinion(s), is inconsistent, the Immunization Officer will weigh the relevant evidence and see whether a determination can be made based on the evidence obtained.
17.4.d. If the evidence is consistent, but the Immunization Officer has insufficient evidence to determine whether an exemption may be granted, or if after weighing the evidence the Immunization Officer determines that a conclusion cannot be reached about whether an exemption should be granted, the Immunization Officer will determine the best way to resolve the inconsistency or insufficiency. The action(s) taken by the Immunization Officer will depend on the nature of the inconsistency or insufficiency. The Immunization Officer will try to resolve the inconsistency or insufficiency by taking any one or more of the actions listed in paragraphs 17.4.d.1, 17.4.d.2, and 17.4.d.3. The Immunization Officer might not take all of the actions listed below. The Immunization Officer may also grant the applicant a preliminary exemption as described in subsection 17.3 until sufficient medical evidence is obtained. The Immunization Officer will consider any additional evidence received together with the evidence already obtained.
17.4.d.1. The Immunization Officer may re-contact the physician. If the Immunization Officer obtains medical evidence over the telephone, the telephone report will be sent to the Physician for review, signature, and return;
17.4.d.2. The Immunization Officer may request additional existing records; or
17.4.d.3. The Immunization Officer may request that the physician seek the opinion of a specialist.
17.4.e. When there are inconsistencies in the evidence that the Immunization Officer cannot resolve or when, despite efforts to obtain additional evidence, the evidence is insufficient to determine whether an exemption should be granted, the Immunization Officer will make a determination or decision based on the evidence available.
17.4.f. The Immunization Officer will make the determination or decision based upon the most recent guidance from the Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP) with respect to medical contraindications or precautions for each vaccine.
17.5. Time Standards. A determination on an application for an exemption will be made within 20 days of receipt of a complete request for an exemption. A request that remains incomplete for 45 days will result in the denial of the request.
17.6. Notice of the Immunization Officer’s Decision. The Immunization Officer will mail a written notice of the determination to the physician and the child’s parent or guardian, at their last known address. The written notice will explain in simple and clear language the Immunization Officer’s decision and the reasons for and the effect of the determination. If the Immunization Officer’s determination is in whole or in part unfavorable, the written notice also will contain in understandable language a statement of the case setting forth the evidence on which the determination is based. The notice also will inform the child’s parent or guardian of the right to request a review of the Immunization Officer’s decision by the State Health Officer.
17.7. Documenting Exemptions. The Immunization Officer will ensure that that any exemption granted by the Immunization Officer is entered into the West Virginia Statewide Immunization Information System, Medical Exemption Module.
17.8. Review by the State Health Officer. If the Immunization Officer’s determination is in whole or in part unfavorable, the child’s parent or guardian may request a review of the Immunization Officer’s decision by the State Health Officer.
17.8.a. How to request a review by the State Health Officer. A child’s parent or guardian may request a review of the Immunization Officer’s determination by filing a written request. A request form is available at the West Virginia Division of Immunization Services (DIS) website at the following link: http://www.dhhr.wv.gov/oeps/immunization/Documents/Request%20for%20Appeal-ME-2013.pdf. The request should include:
17.8.a.1. The name and age of the child for whom the exemption is requested;
17.8.a.2. The name and address of the child’s parent or guardian;
17.8.a.3. The reasons you disagree with the previous determination or decision; and
17.8.a.4. A statement of additional evidence to be submitted and the date you will submit it.
17.8.b. When and where to file. The request must be filed with the State Health Officer by U.S. Mail at 305 Capitol Street, Room 702, Charleston, West Virginia 25301; or email at VaccineExemption@wv.gov; or facsimile at 304-558-8736, within 30 days after the date the child’s parent or guardian receives notice of the Immunization Officer’s decision (or within the extended time period if an extension is granted as provided in paragraph 17.8.c.).
17.8.c. Extension of time to request a review. If the child’s parent or guardian fails to request a review within 30 days after the date the child’s parent or guardian receives notice of the Immunization Officer’s determination or decision, the child’s parent or guardian may ask for more time to make their request. The request for an extension of time must be in writing and it must give the reasons why the request for a review was not filed within the stated time period. A request for an extension may be filed by U.S. Mail, facsimile or email as provided by subdivision 17.8.b. If the child’s parent or guardian shows that there is good cause for missing the deadline, the time period will be extended to permit the filing of a request for a review. In determining whether the applicant has shown good cause for missing a deadline to request for review the following will be considered:
17.8.c.1. What circumstances kept the child’s parent or guardian from making the request on time;
17.8.c.2. Whether an action of the Bureau misled you; and
17.8.c.3. Whether the child’s parent or guardian has any physical, mental, educational, or linguistic limitations (including any lack of facility with the English language) which prevented the child’s parent or guardian from filing a timely request or from understanding or knowing about the need to file a timely request for review.
17.8.d. Review procedures. If a request for a review is made, the child’s parent or guardian will be given an opportunity to present any additional written evidence to the State Health Officer. The State Health Officer will then make a decision based on all of this evidence.
17.8.e. Review determination. After the child’s parent or guardian requests a review of the determination of the Immunization Officer, the State Health Officer will review the evidence that the Immunization Officer considered in making the initial determination and any other evidence the State Health Officer receives. The State Health Officer may request additional information of the child’s parent or guardian or the physician to complete the review and provide a decision. The State Health Officer will make a determination based on the preponderance of the evidence.
17.8.f. Time Standards. A determination on a request for a review of the Immunization Officer’s determination will be made within 30 days of receipt of the request for review or, in the event the State Health Officer requests additional information from the child’s parent or guardian or the physician, 30 days from the receipt of the requested information. Failure of the child’s parent or guardian to submit requested information within 45 days of the receipt of the State Health Officer’s request will result in the State Health Officer making a determination based on the evidence available.
17.8.g. Effect of the State Health Officer’s review of the Immunization Officer’s determination. The State Health Officer’s review is binding unless the child’s parent or guardian requests a hearing with 45 days of the receipt of the State Health Officer’s notice of review, as required by the Rules for Contested Case Hearings and Declaratory Rulings, 64 CSR 1.
17.8.h. Notice of the State Health Officer’s Review. The State Health Officer will mail a written notice of the Review of the Immunization Officer’s determination to the applicant at their last known address. The State Health Officer will state the specific reasons for the determination and tell the child’s parent or guardian of the right to a hearing.
64CSR95
64CSR95
Series 97 Maternal Risk Screening
W. Va. Code R. § 64-97-1 General
1.1. Scope. -- This rule further implements the Uniform Maternal Screening Act by setting forth responsibilities of the advisory council created in the Act; developing and establishing the requirement for health care practitioners to use a uniform maternal risk screening tool; and providing for the confidentiality of the tool.
1.2. Authority. -- W. Va. Code §16-1-4 and §16-4E-4.
1.3. Filing Date. -- April 4, 2022.
1.4. Effective Date. -- April 4, 2022.
1.5. Sunset. -- This rule shall terminate and have no further force or effect on August 1, 2027.
W. Va. Code R. § 64-97-2 Application
2.1. Application. -- This rule applies to all health care providers offering maternity services.
2.2. Enforcement. -- This rule is enforced by the Office of Maternal, Child and Family Health in the Bureau for Public Health.
W. Va. Code R. § 64-97-3 Definitions
3.1. Maternal Risk Screening -- Screening conducted by physicians, midwives, and other qualified health care practitioners to discover at-risk and high-risk pregnancies.
3.2. Maternal Risk Screening Advisory Council -- A multidisciplinary group of professionals including representatives from public health and the medical community, all with an interest in improving pregnancy outcomes.
W. Va. Code R. § 64-97-4 Responsibilities of Maternal Risk Screening Advisory Council
4.1. The Maternal Risk Screening Advisory Council shall exercise the following responsibilities:
4.1.1. Meet at least annually;
4.1.2. Offer expert advice to the Office of Maternal, Child and Family Health to gain a better understanding of at-risk and high-risk conditions that are most frequently observed and to develop methodology to address these concerns;
4.1.3. Develop and facilitate ongoing examination of a uniform maternal risk screening tool to identify risk conditions that contribute to adverse pregnancy outcomes and review the tool at least annually to offer suggested revisions based upon current medical knowledge;
4.1.4. Develop, in conjunction with the Office of Maternal, Child and Family Health, a statistical matrix to measure incidence of high-risk and at-risk pregnancies for planning purposes by public health officials; and
4.1.5. Develop methods to collect evidence-based data reported to the Office of Maternal, Child and Family Health needed to track at-risk and high-risk women.
W. Va. Code R. § 64-97-5 Applicability of the Screening Tool
5.1. The maternal risk screening tool, developed by the advisory council, may be found online at https://www.wvdhhr.org/mcfh/. All health care providers offering maternity services shall be required to use this maternal risk screening tool in their initial examination of all pregnant women.
5.2. The health care provider shall notify the woman of any high-risk condition which has been identified along with any appropriate referral.
5.3. The health care provider shall report the maternal risk screening tool results to the Bureau for Public Health, Office of Maternal, Child and Family Health by secure data entry into the web-based application for that purpose, or via FAX (304) 957-0176.
W. Va. Code R. § 64-97-6 Confidentiality
6.1. The uniform maternal risk screening tool shall be confidential and shall not be released or disclosed to anyone for any reason other than data analysis of high-risk and at-risk pregnancies and for planning purposes by public health officials: Provided, That Medicaid or CHIP members’ data from the screening tool may be provided to the Department of Health and Human Resources’ Bureau for Medical Services, which may provide the information to the patient’s contracted managed care organizations to facilitate the timely initiation of case management for at-risk and high-risk pregnancies. The Bureau for Medical Services and its contracted managed care organizations shall conform to all applicable laws and current industry standards governing confidentiality, including the establishment of appropriate administrative, technical, and physical safeguards to protect the confidentiality of the data and to prevent unauthorized use or access to it.
6.2. Proceedings, records, and opinions of the advisory council are confidential and are not subject to discovery, subpoena, or introduction into evidence in any civil or criminal proceeding. Nothing in this subsection is to be construed to limit or restrict the right to discover or use in any civil or criminal proceeding anything that is available from another source and entirely independent of the proceedings of the advisory council.
6.3. Members of the advisory council may not be questioned in any civil or criminal proceeding regarding information presented in or opinions formed as a result of a meeting of the council. Nothing in this subsection may be construed to prevent a member of the advisory council from testifying to information obtained independently of the council or which is public information.
64CSR97
64CSR97
Series 99 Requirements For Licensure Of Nonprofit Corporations For Conservator Service
W. Va. Code R. § 64-99-1 General
1.1. Scope. -- This legislative rule establishes general standards and procedures for the licensure of nonprofit corporations to serve as conservator, limited conservator and temporary conservator of persons declared by circuit courts to be protected persons. This rule is intended to protect and promote the rights and interests of protected persons of all ages for whom corporations are appointed to serve in a conservatorship capacity.
1.2. Authority. -- W. Va. Code §44A-1-8.
1.3. Filing Date. -- May 10, 2011.
1.4. Effective Date. -- May 10, 2011.
W. Va. Code R. § 64-99-2 Application and Enforcement
2.1. Application. -- This legislative rule applies to any nonprofit corporation seeking appointment as conservator, limited conservator or temporary conservator for protected person.
2.2. Enforcement. -- This legislative rule shall be enforced by the Secretary of Health and Human Resources.
W. Va. Code R. § 64-99-3 Definitions
3.1. Words used in this rule have the same meaning as set forth by definition in W. Va. Code §44A-1-4, except insofar as a different meaning is set forth by definition in this section.
3.2. Board of Directors -- Those persons who are vested with the management of the affairs of the corporation, by whatever name they may be called.
3.3. Bylaws -- The code of rules adopted for the regulation or management of the affairs of the corporation irrespective of the name or names by which the rules are called.
3.4. Corporation -- Nonprofit corporations only, which may be taken within context to refer to the corporation as a whole or its members, directors, officers and employees.
3.5. Department -- The West Virginia Department of Health and Human Resources.
3.6. Director -- A member of the board of directors of the Corporation.
3.7. Employee -- Includes officers but not directors of the Corporation. A director may accept duties which make him or her an employee.
3.8. Family -- One or more persons related to the protected person by blood or by marriage, who maintain contact with and interest in the protected person.
3.9. License -- A document issued by the Secretary which constitutes the approval for appointment to serve as conservator, limited conservator and temporary conservator.
3.10. Licensee -- A corporation duly licensed by the Secretary to serve as conservator for individuals who are designated protected persons.
3.11. Member -- A person having membership in the nonprofit corporation in accordance with the provisions of its articles of incorporation or bylaws.
3.12. Secretary -- The Secretary of the Department of Health and Human Resources.
W. Va. Code R. § 64-99-4 State Administrative Procedures
4.1. General Licensure Provisions.
4.1.a. A corporation may not be appointed to serve as conservator, limited conservator or standby conservator for a protected person unless the corporation first obtains a license.
4.1.b. A license is valid only for the corporation named in the license and is not transferable or assignable.
4.1.c. A licensed corporation shall notify the Secretary ninety days in advance of any pending merger or consolidation with another corporation, submitting with the notification a copy of the plan for merger or consolidation.
4.1.d. In the event that the surviving or the new corporation proposes to continue as conservator, limited conservator or standby conservator to any of the protected persons of the licensed corporation, the incorporators of the proposed corporation shall prepare an application as for an initial license, supplying relevant information or documentation of intent where official documents are unavailable. The official documents, such as a copy of the corporation charter shall be filed with Secretary immediately upon receipt. The new or surviving corporation, shall upon the granting of the new license, file notice with the circuit clerk of the continuation of all existing conservatorships, limited conservatorships and temporary conservatorships.
4.1.e. In the event that the new corporation does not propose, is not granted a license, or is not approved by the circuit court to continue as conservator, limited conservator or temporary conservator, the licensed corporation shall dissolve itself from its conservatorships according to law, this rule and the procedures of the corporation as approved by the Secretary.
4.1.f. A corporation shall notify the Secretary in advance of any proposed amendment to its articles of incorporation, requesting a decision from the Secretary as to whether the proposed amendment will affect the status of its license. In the event that the proposed amendment will adversely affect the status of the license, the corporation shall either: (a) abandon the proposed amendment and any proposals for associated activity; or (b) if the amendment is adopted, dissolve itself from its conservatorships according to law, this rule and the procedures of the corporation as approved by the Secretary.
4.1.g. The corporation shall notify the Secretary of any changes in the ownership and management of the corporation specified in Subdivision 4.2.c of this rule within thirty days following the change.
4.1.h. A corporation shall surrender an expired or otherwise invalid license shall be surrendered to the director on written demand.
4.1.i. A license shall state the name of the nonprofit corporation, the type of license, the date of issue, and the date of expiration of the license.
4.2. Initial License.
4.2.a. An applicant shall submit an application to the Secretary on forms provided by the Secretary not less than thirty days and not more than ninety days prior to the date proposed for commencement of operation. A nonrefundable fee of $100.00 shall be submitted with the application.
4.2.b. Information required for the initial license and any renewal may include affirmative evidence of ability to comply with this rule and with any other requirement of law, and shall include, at the lease, information showing that the corporation:
4.2.b.1. Has sufficient fiscal and administrative resources to perform the fiduciary duties and make the reports and accounting required by Chapter 44A of the West Virginia Code;
4.2.b.2. Will respect and maintain the dignity and privacy of the protected person;
4.2.b.3. Will protect and advocate the legal human rights of the protected person;
4.2.b.4. Will assure that the protected person is receiving appropriate education, vocational, residential and medical services in the setting least restrictive of the individual’s personal liberty;
4.2.b.5. Will encourage the protected person to participate to the maximum extent of his or her abilities in all decisions affecting him or her and to act in his or her own behalf on all matters in which he or she is able to do so;
4.2.b.6. Does not provide education, vocation, residential or medical services to the protected person; and
4.2.b.7. Has written provisions in effect for the distribution of assets and for the appointment of temporary conservators for any protected persons it serves in the event the corporation ceases to be licensed by the Department or otherwise becomes unable to serve.
4.2.c. The applicant shall submit the following information pertaining to ownership and management of the corporation to the Secretary: (a) the names, addresses and place of employment of all officers and directors of the corporation; (b) the name and address of the individual to receive notices and orders; (c) the address of the principal office of the corporation; (d) the names and addresses of all other offices or locations of the corporation where activities related to the conservatorship services are performed; and (e) the name and address of any parent or subsidiary corporation and the names and addresses of its officers and directors.
4.2.d. The application shall include a copy of: (a) the articles of incorporation filed with the West Virginia Secretary of State; (b) a copy of the corporate charter issued by the Secretary of State; (c) the ruling or determination of the federal government regarding the corporation’s status as a tax-exempt nonprofit corporation under federal income tax statutes and regulations; and (d) the letter of approval for nonprofit status under the tax laws of West Virginia issued by the State Tax Commissioner.
4.2.e. The Secretary shall issue an initial license if he or she finds that: (a) the corporation is in conformance with or, in the case of proposed activities, supplies satisfactory evidence of ability and intent to conform to this rule and with applicable law and (b) has submitted a complete application and the application fee. Within sixty days of the issuance of an initial license the applicant shall provide proof of liability insurance to the Secretary and the proof shall be maintained in the records of the Secretary relating to that license.
4.2.f. The Secretary shall issue an initial license, which shall be valid for a term of two years from the date of issuance, subject to the conditions and penalties specified in this rule.
4.3. Renewal License.
4.3.a. An applicant for a renewal license shall submit an application to the Secretary on forms provided by the Secretary not less than thirty days and not more than sixty days prior to the expiration date of the current license. A nonrefundable fee of one hundred dollars shall be included with the application.
4.3.b. The Secretary shall issue a renewal license when he or she finds that: (a) the corporation is in compliance with the provisions of this rule and with applicable law and (b) the corporation has submitted a complete application and the renewal license fee.
4.3.c. The Secretary shall issue a renewal license, which shall be valid for a term of two years from the date of issuance, subject to the conditions and penalties specified in this rule.
4.4. Provisional License.
4.4.a. If the Secretary finds that a corporation applying for a renewal license is not in compliance with the requirements of this rule, he or she may issue a provisional license.
4.4.b. A provisional license may be issued only when the corporation has demonstrated improvement in deficiencies and the potential for compliance within the term for which the provisional license is issued.
4.4.c. The term of a provisional license is at the discretion of the Secretary, but in no case may be longer than twelve months.
4.4.d. A provisional license may not be renewed.
4.5. Inspections.
4.5.a. The Secretary shall conduct at least one on-site survey of the corporation and its activities biennially. The surveys shall include one or more of the locations from which the corporation provides services. Surveys shall include inspections of individual protected person conservatorship and financial records and corporation records required by law and this rule. Surveys may include visits and interviews with clients, employees, contractors for services and other persons as relevant. In the event that materials of record qualify as privileged attorney-client information, the corporation shall make available to the Secretary for inspection that information of record not related to the matter under attorney-client privilege.
4.5.b. The Secretary shall send a report of any initial or renewal license inspection of the corporation within fifteen working days of the completion of the inspection.
4.6. Complaint Investigation.
4.6.a. Any person may register a complaint with the Secretary alleging violation of applicable laws or rules by the corporation. A complaint shall state the substance of the complaint and the corporation by name.
4.6.b. The Secretary shall conduct an investigation of the complaint and shall prepare a report of his or her investigation.
4.6.c. Within ten working days after the completion of its investigation, the Secretary shall notify the corporation and the circuit court which appointed the conservator of the complaint, the results of its investigation and any corrective action required to be taken by the corporation.
4.7. Plans of Correction.
4.7.a. A corporation found on the basis of inspection or other investigation to have deficiencies in compliance with this rule shall develop a plan for correction of the deficiencies and shall submit the plan to the Secretary within thirty days of receipt of the report of the inspection or other investigation.
4.7.b. The plan of correction shall specify:
4.7.b.1. The deficiencies to be corrected;
4.7.b.2. Action taken or proposed to correct the deficiencies and procedures proposed to prevent their recurrence;
4.7.b.3. The time within which the deficiencies will be corrected. That time shall be the shortest possible time within which a corporation may reasonably be expected to correct the deficiencies.
4.7.c. The Secretary shall approve, modify or reject in whole or in part the plan of correction in writing within ten working days of receipt.
4.7.d. In accepting, modifying or rejecting the plan for correction, the Secretary shall consider:
4.7.d.1. The adequacy of the actions and procedures taken or proposed to correct the deficiencies;
4.7.d.2. The seriousness of the deficiencies;
4.7.d.3. The number of protected persons affected;
4.7.d.4. The time proposed for effectuating the correction; and
4.7.d.5. Any other relevant factors.
4.7.e. The Secretary shall specifically state the reasons for modifying or rejecting a proposed plan of correction.
4.7.f. When the Secretary rejects a plan of correction, a reasonable time for submission of a revised plan shall be allowed: Provided, that the Secretary may require an immediate correction of deficiencies that present a danger of immediate risk of loss to the estate of a protected person.
4.7.g. The Secretary shall conduct any reasonable and necessary procedures to ensure the correction of any deficiencies identified during a routine licensure inspection or any other investigation.
4.8. Secretary Reports and Records.
4.8.a. A report of any inspection or investigation made by the Secretary shall be in writing and shall be on file with the Secretary.
4.8.b. Reports of the Secretary of any inspection or investigation shall, when appropriate, specify the nature of any deficiency in compliance with this rule or law and specifically indicate the rule or law violated.
4.8.c. The Secretary shall make available for public inspection the following:
4.8.c.1. Applications and exhibits;
4.8.c.2. Inspection reports;
4.8.c.3. Reports of any other investigations;
4.8.c.4. Any records of hearings, decisions and declaratory rulings; and
4.8.c.5. Any responses of the corporation requested to be made part of the public record.
4.8.d. The Secretary shall provide copies of materials available for public information at a nominal cost upon written request.
4.8.e. The Secretary shall treat a report of inspection of a corporation as public information from the time a written plan of correction is submitted.
4.8.f. If the corporation does not submit a written plan of correction within the time specified by the Secretary or this rule, reports pertaining to the corporation shall be made public at the expiration of the specified time.
4.8.g. Before releasing a report or record considered public information, the Secretary shall delete any confidential information regarding a protected person which could reasonably permit identification of the protected person.
4.8.h. The Secretary shall delete from complaints made available to the public under this section any information required to be held confidential under this rule or state or federal law.
W. Va. Code R. § 64-99-5 General Organization and Management
5.1. The corporation shall have a valid West Virginia charter to conduct business as a nonprofit corporation.
5.2. A major purpose of the corporation shall be to aid and assist and to promote the rights and well-being of protected persons. The corporation may have purposes other than the provision of conservatorship services as specified in this rule: Provided, that the purposes shall not conflict with the corporation’s responsibilities as conservator, limited conservator or temporary conservator.
5.3. Except as provided in this rule, a corporation licensed under this rule, and any officer, agent, director, servant or any employee of the corporation shall not do business with or in any way profit, either directly or indirectly, from the estate or income of any protected person for whom the corporation serves as conservator, limited conservator, or temporary conservator.
5.4. Each director, officer, agent and employee of the corporation shall file with the Secretary an annual written statement under oath regarding conflict of interest under this rule in a format specified by the Secretary.
5.5. A corporation licensed under this rule shall not provide educational, vocational, residential or medical services to its protected persons or to other protected persons.
5.6. The corporation shall have a duly constituted board of directors and officers as prescribed by law.
5.7. The corporation shall have bylaws in accordance with the state laws and this rule which shall provide for at least the following:
5.7.a. Specification of the powers and duties of the board of directors, the officers and the committees;
5.7.b. The number and length of term of the members of the board of directors and of the officers;
5.7.c. The qualifications and the method of selection of the members of the board of directors;
5.7.d. The frequency of board and of corporation meetings;
5.7.e. The classes of members and their voting privileges;
5.7.f. An annual audit by an accredited auditor; and
5.7.g. An annual report of all activities of the corporation.
5.8. The corporation shall have written policies and procedures consistent with this rule which shall include at a minimum:
5.8.a. The distribution of the assets of protected persons in the event the corporation ceases to be licensed by the Secretary or otherwise becomes unavailable to act as conservator;
5.8.b. The nomination of and the application to the circuit court for the appointment of a temporary conservator in the event the corporation ceases to be licensed by the Secretary or otherwise becomes unable to act as conservator; and
5.8.c. Other policies and procedures required by this rule.
5.9. The corporation shall have an executive director who:
5.9.a. Is responsible for the operation and the administration of the corporation on a day-to-day basis;
5.9.b. Is supervised and evaluated by the board of directors of the corporation; and
5.9.c. Is responsible for the supervision and evaluation of staff.
5.10. The corporation shall not discriminate in any matter of employment on the basis of race, color, national origin, ancestry, religion, physical handicap or sex and shall abide by all provisions of applicable local, state and federal law and rules and regulations regarding employment.
5.11. The corporation shall not discriminate among protected persons or refuse to accept as protected persons any individual on grounds of race, color, religion, national origin, sex or financial resources: Provided, the protected persons resources meet the requirements of W. Va. Code §44A-1-8.
5.12. The corporation shall maintain the confidentiality of all protected persons-identifiable records in its custody or accessible to the corporation in the performance of its duties as conservator, limited conservator or temporary conservator and shall comply with all state and federal laws regarding the confidentiality of financial records, health records or other records.
5.13. The corporation shall maintain separate financial records for each protected person for whom it serves as conservator and shall comply with all state and federal law regarding administration of the estate of the protected person.
5.14. The corporation shall develop and implement necessary and appropriate employee procedures and sanctions and office procedures to protect the confidentiality of the records of protected persons and to effectuate the release of the records to proper interested parties.
5.15. Where state law or this rule requires the provision of services by the corporation in the financial affairs of a protected person, the corporation may, unless specified otherwise by this rule, contract for or accept as a donation the services to be provided: Provided, that the contractor and the donor agree to comply with the provisions of this rule and relevant state and federal law and rules and regulations and agree to undergo survey and inspection procedures regarding compliance with this rule. When services are to be donated or provided on a volunteer basis there shall be a written specification of the extent and the nature of services to be provided and activities to be performed by the donor or volunteer. In the event that such services are performed by entities other than the corporation, the corporation shall be held responsible for the adequacy and effectiveness of those services.
5.16. The corporation shall have on file all orders, authorizations and directions of the circuit court regarding the protected person.
5.17. The corporation shall not exceed the authority of any of the orders, authorizations or directions of the circuit court.
5.18. The corporation shall carry liability and other insurance to protect the corporation from foreseeable liabilities arising from the performance of its conservatorship duties and responsibilities. The insurance shall be adequate in amount and coverage to protect all of the estates managed by the corporation against accidental loss. The corporation shall also procure vehicular and property insurance on property owned by the protected person as appropriate.
5.19. The corporation shall retain legal counsel to assist in making arrangement for and in performing its conservatorship duties and responsibilities.
5.20. The license shall be displayed in a conspicuous and public place in plain view of all protected persons, clients, and visitors to the office of the corporation and a copy of the license shall be displayed in like manner in every office and location of the corporation.
W. Va. Code R. § 64-99-6 Fiduciary Responsibilities and Rights
6.1. The corporation shall provide evidence that it has sufficient fiscal and administrative resources to perform its fiduciary duties and to make the fiduciary accountings and reports required by law and this rule. An independent certified public accountant shall audit the corporation at least annually. The audit shall be sent to the Secretary within one week of receipt by the corporation. The evidence shall be submitted with its initial and each renewal application and shall, at a minimum include:
6.1.a. A report of the corporation which shall include a complete statement of all assts, liabilities, income and expenses of the corporation for the period covered;
6.1.b. A record of insurance;
6.1.c. A statistical summary of reports and records submitted to the circuit court, the number and type of reports required and the employees available to effectuate these reports; and
6.1.d. A statistical summary report of any other activities effectuating the provisions of law and this rule concerning estate management and the securing of financial support for the protected person.
6.2. The corporation may make arrangement for part of all of the activities required to be performed in the management of a protected person’s financial affairs to be executed by other lawful entities: Provided, that the corporation shall provide written evidence that it has reviewed and approved the activities of the entities for compliance with the requirements of relevant law and this rule at least annually. The arrangements shall comply with the provisions of Subsection 5.17 of this rule.
6.3. A blanket insurance certificate encompassing some or all of the estates of protected persons of the corporation is acceptable for the purposes of this rule: Provided, that the blanket certificate is ruled acceptable by the circuit court making the appointment of the corporation as conservator, limited conservator or temporary conservator.
6.4. The corporation shall manage the income, property and any assets of each protected person for the benefit of the protected person and shall retain evidence that any expenditures of income from the estate of the protected person for which it has lawful authority are used for the benefit of the protected person.
6.5. The corporation shall implement procedures to facilitate that any protected person receives maximum support for his or her needs by:
6.5.a. Annually reviewing the status of the protected person’s eligibility for any public support programs; and
6.5.b. Intervening as needed to ensure that any financial or other support continues.
6.6. The corporation shall maintain current detailed individual financial accounts and records for each protected person. Each account shall be maintained as separate account and the funds of the protected person may not be comingled with any other funds. The corporation shall show on the accounts payments and compensation for services performed for the protected person by it and for all other services received by the protected person. The corporation shall provide a statement of the protected person’s account at least monthly and upon request to the protected person or the protected person’s guardian or attorney in fact if a guardian or attorney in fact has been appointed.
6.7. The corporation shall have on file all financial reports submitted to the circuit court.
6.8. The Secretary may require the certification of specified reports and accounts of protected persons and of the corporation by the corporation’s auditor or by an independent accountant.
6.9. Any corporation licensed under this rule and serving as conservator, limited conservator, or temporary conservator shall be entitled to reasonable compensation as provided by law for services provided as conservator.
W. Va. Code R. § 64-99-7 Management of Conservatorship of the Protected Person
7.1. Services Generally.
7.1.a. The corporation shall maintain an effective and direct role in the execution of its conservatorship responsibilities. To this end, the corporation shall through its membership, employees, officers and directors be directly responsible for certain requirements specified in this rule. The corporation may effectuate other responsibilities as specified in Subsection 5.15. of this rule.
7.1.b. A protected person shall receive services according to his or her needs, characteristics, and capabilities.
7.1.c. The corporation shall have documented regular contact with the protected person as frequently as indicated by the needs, characteristics, capabilities, living circumstances and any other pertinent conditions of the protected person and as feasible to the fiscal resources of the protected person and the corporation: Provided, that there shall be no less than one person-to-person contact between the corporation membership or staff and the protected person per year.
7.1.d. The corporation shall encourage protected persons to participate to the maximum of their abilities in all decisions affecting them.
7.2. Staffing.
7.2.a. The corporation shall designate a specific representative for each protected person of the corporation. This responsibility may not be satisfied through contract or arrangement with another entity.
7.2.b. The representative shall be responsible for maintaining continuity of the corporation’s relationship to the protected person and shall be personally familiar with the protected person and his or her circumstances.
7.2.c. Conservator representatives shall be qualified for their jobs by virtue of training, experience or a combination of both. The corporation shall develop detailed statements of the experience and training requirements for conservator representatives. The corporation may provide or arrange for training, where needed, to supplement deficiencies in the representative’s capabilities to perform the job. The representative shall be given supervision or consultation by an individual who is appropriately qualified until training is sufficient.
7.2.d. The corporation shall maintain an employee training program which shall provide at a minimum:
7.2.d.1. Orientation and training for new employees and volunteers to acquaint them with the philosophy, organization, programs, practices and goals of the corporation;
7.2.d.2. Orientation to talking competently with protected persons for purposes of a routine contact basis.
7.2.d.3. Additional initial and continued training needed specific to the duties, the responsibilities and the competency of the employee; and
7.2.d.4. Training in management of accounts, property and financial assets.
7.3. Protection and Advocacy.
7.3.a. The corporation shall define procedures for the procuring or provision of legal counsel to represent the interests of the protected person and shall procure legal counsel when it is in the best interests of the protected person. Any person providing legal services to the corporation shall not be eligible to act as legal counsel for the protected person.
7.3.b. The corporation shall inform the protected person regarding the procedures for terminating or changing the type of conservatorship or the conservator.
7.3.c. The corporation shall assure that those persons who provide services to the protected person respect the rights and dignity of the protected person.
7.3.d. The corporation shall not perform any conservatorship function for any individual in the absence of lawful proceedings appointing the corporation as conservator, limited conservator or temporary conservator.
7.3.e. The corporation may advise and assist families in implementing procedures to initiate conservatorship.
7.3.f. Each corporation shall establish a conservatorship review committee to:
7.3.f.1. Review and otherwise pass upon all applications for conservatorship;
7.3.f.2. Oversee the administration of accepted conservatorships;
7.3.f.3. Review each case on a periodic basis to determine that conservatorship is in the best interest of each client and, if not, to petition for termination of the conservatorship; and
7.3.f.4. Contact information for the protected person’s next of kin.
W. Va. Code R. § 64-99-8 Conservatorship Records and Reporting
8.1. The corporation shall maintain a conservatorship record for each protected person for whom it has responsibility for full or limited conservatorship of the person. The conservatorship record shall document all information and activities pertinent to the conservatorship and as required by law and this rule.
8.2. The conservatorship record shall contain at a minimum the following information concerning the protected person:
8.2.a. A summary of all orders and directions of the circuit court concerning the protected person and the conservatorship;
8.2.b. A record of services provided by the corporation staff;
8.2.c. A summary report of any services provided under contract;
8.2.d. Evaluations of services provided to the protected person;
8.2.e. Copies of any reports provided to the circuit court;
8.2.f. A record of any other activities undertaken on behalf of the protected person; and
8.2.g. An annual summary report regarding the estate of the protected person reflecting all financial transactions that have affected the estate, and an evaluation and description of the assets of the estate.
8.4. The corporation shall maintain on file a current summary list of the names and addresses of all protected persons for whom it is acting as conservator.
8.5. With any renewal application the corporation shall provide the Secretary a statistical summary report to include the number of protected persons, the type of conservatorships, the ages of protected persons, the number of visits, emergency contacts, services provided and any other information reasonably required by the Secretary in a format designated by the Secretary.
W. Va. Code R. § 64-99-9 Penalties
9.1. The Secretary may suspend or revoke a license if it finds that: (a) the corporation is in substantial violation of this rule; (b) the corporation charges fees in excess of those authorized by the circuit court or the fiduciary commissioner; (c) the corporation is found by due process of law to be in violation of the provisions of Chapters 31, 44, or 27 of the Code of West Virginia of 1931, as amended; or (d) the corporation has violated any state or federal law or has in any way violated its fiduciary duty to the protected person.
9.2. The Secretary may refuse to grant a license or may revoke a license if it determines that there has been subterfuge or other dishonest action in applying for an initial or a renewal license.
W. Va. Code R. § 64-99-10 Administrative Due Process
Those persons adversely affected by the enforcement of this legislative rule desiring a contested case hearing to determine any rights, duties, interests or privileges shall do so in a manner prescribed in W. Va. C.S.R. §16-1-1 et seq.
64CSR99
64CSR99
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