12VAC5-475 Regulations Implementing the Virginia Organ and Tissue Donor Registry

REGULATIONS

Vol. 30 Iss. 8 - December 16, 2013

TITLE 12. HEALTH

STATE BOARD OF HEALTH

Chapter 475

Proposed Regulation

Title of Regulation: 12VAC5-475. Regulations Implementing the Virginia Organ and Tissue Donor Registry (amending 12VAC5-475-10, 12VAC5-475-30, 12VAC5-475-50 through 12VAC5-475-90; adding 12VAC5-475-75; repealing 12VAC5-475-20, 12VAC5-475-40).

Statutory Authority: § 32.1-292.2 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: February 14, 2014.

Agency Contact: Janice Hicks, Department of Health, 109 Governor Street, Richmond, VA 23219, telephone [phone], FAX (804) 864-7670, or email [e-mail].

Basis: Section 32.1-292.2 of the Code of Virginia requires the State Board of Health, in consultation with the Virginia Transplant Council, to promulgate regulations necessary to create, compile, maintain, modify as necessary, and administer the Virginia Donor Registry.

Purpose: Several aspects of the regulations regarding the Virginia Donor Registry need updating and clarifying. The current regulations were the first promulgated under statutory authority granted by the 2000 Session of the Virginia General Assembly and have been in effect since March 27, 2002, without amendment. The board has concluded that amendments to the regulations are necessary to provide clarity, improve efficiency and effectiveness, and bring the regulations in line with current practice. The proposed amendments will assist in ensuring the public health, safety, and welfare of the citizens of the Commonwealth by (i) making it simpler for individuals to become organ donors, thereby increasing the number of donors and (ii) allowing the Virginia Transplant Council to collect and report accurate statistics on organ donation to the Department of Health.

Substance: The proposed amendments include:

1. Changing the references from the Virginia Organ and Tissue Donor Registry to the Virginia Donor Registry.

2. Replacing references to §§ 32.1-289 and 32.1-290 of the Code of Virginia, which were repealed by the 2007 General Assembly, with references to the Revised Uniform Anatomical Gift Act (§ 32.1-291.1 et seq. of the Code of Virginia).

3. Updating definitions for consistency with the Revised Uniform Anatomical Gift Act.

4. Amending the definition of "document of gift" to reference the donor registration form available on the DonateLifeVirginia.org website, and amending the definition of "registry" to clarify that the Virginia Transplant Council is responsible for creating, compiling, maintaining, and modifying the Virginia Donor Registry.

5. Adding a definition for "designee," which is used throughout the regulation to refer to a person who is designated to use the Virginia Donor Registry for certain limited purposes.

6. Adding DonateLifeVirginia.org to the definition section to identify the official website that provides information on organ and tissue donation and provides a registration form to indicate a willingness to donate.

7. Clarifying data requirements that the Virginia Transplant Council shall maintain and annually report to the State Board of Health.

8. Providing that persons may indicate their willingness to donate by completing the Donor Registration Form available on the DonateLifeVirginia.org website and eliminating the necessity for the Virginia Transplant Council to contact persons who identify their willingness to be a donor through the Department of Motor Vehicles to complete a registration form.

Issues: There are no disadvantages to the public. The identification of the DonateLifeVirginia.org website as an available resource on organ and tissue donation and the ability to complete an online registration to indicate a willingness to donate are advantages for the public.

There are no disadvantages to the agency or the Commonwealth. An advantage to both the State Board of Health and the Virginia Transplant Council is that the amended regulations will provide greater clarification of the information that the council must annually report to the board.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Board of Health (Board) proposes to update and clarify the current Regulations Implementing the Virginia Organ and Tissue Donor Registry. The proposed amendments include changing the references to the Virginia Organ and Tissue Donor Registry to the "Virginia Donor Registry" as determined by the 2006 amendments to §§ 32.1-292.2 and 32.1-297.1 of the Code of Virginia and to replace references to §§ 32.1-289 et seq. and 32.1-290, which were repealed by the 2007 General Assembly, with references to the Revised Uniform Anatomical Gift Act (§ 32.1-291.1 et seq.). Also the Board proposes to make definitions consistent with the Revised Uniform Anatomical Gift Act (§ 32.1-291.1 et seq.), to delete definitions no longer required or used in the text, and to amend or add definitions to include donor registration processes available on the DonateLifeVirginia.org website and clarify other functions and entities. Further the Board proposes to specify the data that are maintained and annually reported to the Board, to specify that designees may assist individuals to complete a signed application and that people may indicate their willingness to donate through a donor registration process or mail-in form available on the DonateLifeVirginia.org website.

Result of Analysis. The benefits likely exceed the costs for all proposed changes.

Estimated Economic Impact. None of the proposed amendments change requirements in practice. Thus, the proposed amendments have no impact beyond improving clarity.

Businesses and Entities Affected. These regulations affect the four organ procurement organizations, two eye banks, four tissue recovery agencies and hospitals in the commonwealth, as well as associated medical staff, potential donors and transplant recipients.

Localities Particularly Affected. There are no localities that bear any identified disproportionate material impact from these amended regulations.

Projected Impact on Employment. The proposed amendments do not affect employment.

Effects on the Use and Value of Private Property. The proposed amendments do not significantly affect the value and use of private property.

Small Businesses: Costs and Other Effects. The proposed amendments do not produce costs for small businesses.

Small Businesses: Alternative Method that Minimizes Adverse Impact. The proposed amendments do not adversely affect small businesses.

Real Estate Development Costs. The proposed amendments do not affect real estate development costs.

Legal Mandate. The Department of Planning and Budget (DPB) has analyzed the economic impact of this proposed regulation in accordance with § 2.2-4007.04 of the Administrative Process Act and Executive Order Number 14 (10). Section 2.2-4007.04 requires that such economic impact analyses include, but need not be limited to, the projected number of businesses or other entities to whom the regulation would apply, the identity of any localities and types of businesses or other entities particularly affected, the projected number of persons and employment positions to be affected, the projected costs to affected businesses or entities to implement or comply with the regulation, and the impact on the use and value of private property. Further, if the proposed regulation has adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include (i) an identification and estimate of the number of small businesses subject to the regulation; (ii) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the regulation, including the type of professional skills necessary for preparing required reports and other documents; (iii) a statement of the probable effect of the regulation on affected small businesses; and (iv) a description of any less intrusive or less costly alternative methods of achieving the purpose of the regulation. The analysis presented above represents DPB's best estimate of these economic impacts.

Agency's Response to Economic Impact Analysis: The Virginia Department of Health concurs with the findings of the economic impact analysis.

Summary:

The proposed amendments (i) change references to the Virginia Organ and Tissue Donor Registry to the Virginia Donor Registry to conform to 2006 amendments to §§ 32.1-292.2 and 32.1-297.1 of the Code of Virginia and replace references repealed by the 2007 Session of the General Assembly with references to the Revised Uniform Anatomical Gift Act (§ 32.1-291.1 et seq. of the Code of Virginia); (ii) remove unnecessary definitions and modify definitions for consistency with the Revised Uniform Anatomical Gift Act and to include donor registration processes available on the DonateLifeVirginia.org website; (iii) specify the data that are maintained and annually reported to the State Board of Health; (iv) specify that designees may assist individuals in completing a signed application; and (v) specify that a willingness to donate may be indicated through a donor registration process or mail-in form available on the DonateLifeVirginia.org website.

CHAPTER 475
REGULATIONS IMPLEMENTING THE VIRGINIA ORGAN AND TISSUE DONOR REGISTRY

Part I
Definitions and General Information

12VAC5-475-10. Definitions.

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

"Agent" means an adult appointed by the declarant under an advance directive, executed or made in accordance with the provisions of § 54.1-2983 of the Code of Virginia, to make health care decisions for him, including decisions relating to visitation, provided the advance directive makes express provisions for visitation and subject to physician orders and policies of the institution to which the declarant is admitted. The declarant may also appoint an adult to make, after the declarant's death, an anatomical gift of all or any part of his body pursuant to Article 2 (§ 32.1-289 et seq.) of Chapter 8 of Title 32.1 of the Code of Virginia.

"Anatomical gift" or "organ donation" means a donation of organs, tissues, or eyes or all or any part of a human body to take effect upon or after death all or part of a human body to take effect after the donor's death for the purpose of transplantation, therapy, research, or education.

"Board" means the State Board of Health.

"Commissioner" means the State Health Commissioner or his duly designated officer or agent.

"Decedent" means a deceased individual and includes a stillborn infant or fetus whose body or part is or may be the source of an anatomical gift. The term includes a stillborn infant and, subject to restrictions imposed by law other than the restrictions imposed by the Revised Uniform Anatomical Gift Act (§ 32.1-291.1 et seq. of the Code of Virginia), a fetus.

"Department" means the State Virginia Department of Health.

"Designee" means a person designated by an organ procurement organization, eye bank, or tissue bank to identify and determine the suitability of a potential donor.

"Document of gift" means a donor card, a statement attached to or imprinted on a motor vehicle driver's or chauffeur's license or the record of the individual's motor vehicle driver's or chauffeur's license, a will, an advance directive, or other writing used to make an organ donation or an anatomical gift or other record used to make an anatomical gift. The term includes a statement or symbol made pursuant to § 46.2-342 G of the Code of Virginia on a driver's license, an identification card, or a donor registry. "Document of gift" also includes a record of the donor's gift stored in a registry.

"DonateLifeVirginia.org" means the official Virginia website that provides information on organ and tissue donation and provides a registration form for registrants to make an anatomical gift in accordance with the Revised Uniform Anatomical Gift Act (§ 32.1-291.1 et seq. of the Code of Virginia).

"Donor" means an individual who makes a donation of organs, tissues, or eyes or an anatomical gift of all of his body whose body or part is the subject of an anatomical gift.

"Disseminate" means to release, transfer, or otherwise communicate information orally, in writing, or by electronic means.

"Eye bank" means an agency a person that is licensed, accredited, or regulated under federal or state law to engage in the recovery, screening, testing, processing, storage, or distribution of human eyes or portions of human eyes and that is a member of the Virginia Transplant Council, accredited by the Eye Bank Association of America or the American Association of Tissue Banks and operating in the Commonwealth of Virginia.

"Guardian" means a person appointed by the a court who is responsible for the personal affairs of an incapacitated person, including responsibility for making decisions regarding the person's support, care, health, safety, habilitation, education, and therapeutic treatment, and, if not inconsistent with an order of commitment, residence. Where the context plainly indicates, the term includes a "limited guardian" or a "temporary guardian." The term includes a local or regional program designated by the Department for the Aging as a public guardian pursuant to Article 2 (§ 2.2-711 et seq.) of Chapter 7 of Title 2.2 of the Code of Virginia to make decisions regarding the support, care, education, health, or welfare of an individual. The term does not include a guardian ad litem, except when the guardian ad litem is authorized by a court to consent to donation.

"Informed consent" means the knowing and voluntary agreement, obtained without undue influence or any use of force, fraud, deceit, duress, or other form of constraint or coercion, of a person who is capable of exercising free power of choice.

"Organ procurement organization" means an agency certified by the United States Health Care Financing Administration a person designated by the Secretary of the U.S. Department of Health and Human Services as an organ procurement organization that is also a member of the Virginia Transplant Council.

"Part" means an organ, tissue, eye, bone, artery, blood, fluid or other portion of a human body an eye, or tissue of a human being. The term does not include the whole body.

"Personal information" means all information that describes, locates or indexes anything about an individual, as defined in § 2.2-3801 of the Code of Virginia.

"Procurement" means the recovery of any donated part by a licensed physician licensed, accredited, or approved under the laws of any state or a technician who is qualified in accordance with § 32.1-291.14 of the Code of Virginia.

"Registry" means the Organ and Tissue Virginia Donor Registry for the Commonwealth, which shall be administered by the Department of Health created, compiled, operated, maintained, and modified as necessary by the Virginia Transplant Council in accordance with § 32.1-292.2 of the Code of Virginia. The registry shall maintain and update, as needed, the pertinent information on all Virginians who have indicated a willingness to donate.

"Tissue bank" means an agency a person that is licensed, accredited, or regulated under federal or state law to engage in the recovery, screening, testing, processing, storage, or distribution of tissue, and that is a member of the Virginia Transplant Council, accredited by the American Association of Tissue Banks, and operating in the Commonwealth of Virginia.

"UNOS" means the United Network for Organ Sharing.

"VTC" means the Virginia Transplant Council, a program within the Virginia Department of Health that exists to promote and coordinate educational and information activities as related to the organ, tissue, and eye donation process and transplantation in the Commonwealth of Virginia.

12VAC5-475-20. Purpose. (Repealed.)

These regulations are designed to accomplish the tasks listed in § 32.1-292.2 C 1 and 2 of the Code of Virginia by establishing procedures for the administration of the registry.

12VAC5-475-30. Administration.

A. The board has the responsibility for promulgating regulations, in consultation with the VTC, pertaining to the administration of the organ and tissue donor registry.

B. The commissioner is the executive officer for the State Board of Health with the authority of the board when it is not in session, subject to the rules and regulations of and review by the board.

C. A. The VTC, as delegated authorized by the board pursuant to § 32.1-292.2 D 2 of the Code of Virginia, is responsible for analyzing shall analyze registry data under research protocols directed toward determination and identification of means to promote and increase organ, eye, and tissue donation within the Commonwealth.

D. Confidentiality. B. All persons responsible for the administration of the organ and tissue donor registry Virginia Donor Registry shall ensure that the registry and all information therein shall be confidential in accordance with §§ 32.1-127.1:03 and 32.1-292.2 B of the Code of Virginia and other applicable state and federal law.

C. The VTC shall maintain and report annually the following information to the board: (i) the number of unique individuals registered in the registry; (ii) the number of recovered organ donors; (iii) the number or recovered organ donors who were identified through the registry; (iv) the number of recovered tissue donors; (v) the number of recovered tissue donors who were identified through the registry; (vi) the number of recovered eye/cornea donors; and (vii) the number of recovered eye/cornea donors identified through the registry. This report shall be made on or before September 30 of each year and contain information pertaining to the previous fiscal year.

12VAC5-475-40. Access. (Repealed.)

The registry and all information therein shall be accessible 24 hours a day and only to the department and the specific designees of accredited organ procurement organizations, eye banks and tissue banks operating in or serving Virginia and which are members of the VTC, for the purpose of identifying a potential donor according to the provisions of §§ 32.1-127.1 and 32.1-292.2, and subsection F of § 46.2-342.

The name of such designees shall be provided to the VTC. All other persons or entities shall be prohibited from having access to the registry. If at any time the designee is unable to carry out his responsibilities with respect to the registry, a replacement shall be selected and the VTC shall be notified of such replacement.

All accredited organ procurement organizations, eye banks, and tissue banks with authorized access to the registry shall be required to report annually to the VTC the following outcome data: (i) the number of times the registry is accessed; (ii) the number of times access to the registry results in an unsuccessful search (i.e., the individual is not a member of the registry); (iii) the number of times an organ, tissue or eye procurement proceeds solely from accessing the registry; (iv) the number of times the next of kin's consent is obtained in addition to a successful search of the registry; (v) the number of times donation of organs, tissue, or eyes occurred as a result of alternative donation designation documentation; and (vi) the number of times the next of kin's consent is obtained without accessing the registry.

Part II
Registry Information

12VAC5-475-50. Registry membership.

Those persons 18 years and older who have indicated a willingness to donate in accordance with § 32.1-290 of the Code of Virginia and have completed the required registration form (VTC-1) shall be recorded in the registry. Persons under the age of 18 may enter the registry upon completion of the registration form and only with the written consent of his parent or legal guardian. No person may enter another person in the registry. The registry shall record anatomical gifts made in accordance with the Revised Uniform Anatomical Gift Act (§ 32.1-291.1 et seq. of the Code of Virginia). Designees may assist individuals to complete a signed donor registration form.

Those persons who have indicated a willingness to donate designated an anatomical gift on their driver's license or personal identification card as authorized by the Department of Motor Vehicles will be automatically entered into the registry. Through inter-agency interagency agreement, the Department of Motor Vehicles will assist the department by electronically providing this information to the registry on a daily regular basis as agreed upon by the Department of Motor Vehicles and the VTC. The VTC shall contact any such self-identified persons by United States mail regarding notification of membership to the registry and request the completion of the registration form (VTC-1). Persons who make an anatomical gift by completing the donor registration form available on the DonateLifeVirginia.org website will also be automatically entered into the registry.

12VAC5-475-60. Data to be recorded.

The following information shall be recorded in the registry: the donor's full name, address (including county or independent city of residence with zip code), telephone number, date of birth, age, sex, race, and driver's license number or unique identification number. If the donor is under the age of 18, the name, telephone number, address, and unique identification number of the donor's parent or legal guardian shall be recorded.

Information shall be recorded by completing the Virginia Organ and Tissue Donor Registry Form (VTC-1).

12VAC5-475-70. Removal from the registry.

A. A person who has joined the registry may have his name removed amend his anatomical gift or revoke the anatomical gift by filing an appropriate form (VTC-0) with the VTC or in accordance with subsections E and F of § 32.1-290 the Revised Uniform Anatomical Gift Act (§ 32.1-291.1 et seq. of the Code of Virginia) or subsection G I of § 46.2-342 of the Code of Virginia.

B. Persons who revoke an anatomical gift shall be automatically removed from the registry by the VTC.

C. Persons can revoke an anatomical gift by completing any of the following actions:

1. Notifying the VTC in writing using an appropriate form provided by the VTC, which shall result in being removed from the registry upon receipt of notification by the VTC;

2. Completing the form available on the DonateLifeVirginia.org website, which shall result in immediate removal from the registry by the VTC; or

3. Not renewing an anatomical gift when renewing or replacing a driver's license or personal identification card at the Department of Motor Vehicles, which will result in being removed from the registry within 24 hours of receipt of notification to the VTC from the Department of Motor Vehicles.

D. The name of a person entered in the registry who has died shall be removed from the registry within 90 days of notification of death by the Virginia Office Division of Vital Records and Health Statistics.

Part III
Access, Use, and Dissemination of Registry Information

12VAC5-475-75. Access.

A. Except as otherwise provided by law, no person shall have access to the registry except as provided in this section.

B. Designees shall have access to the registry for the purpose of creating, amending, or revoking the registrant's anatomical gift.

C. The registry and all information therein shall be accessible 24 hours a day and only to specific designees of organ procurement organizations, eye banks, and tissue banks for the purpose of identifying a potential donor according to the provisions of §§ 32.1-127 and 32.1-292.2 of the Code of Virginia. The name of such designees shall be provided to the VTC. If at any time the designee is unable to carry out his responsibilities with respect to the registry, a replacement shall be selected and the VTC shall be notified of such replacement.

D. Persons who require access to the registry for operational and maintenance purposes shall have access to the registry upon receipt from VTC of appropriate access privileges.

E. The department shall be provided access to the registry for the purpose of exercising responsibility for oversight of VTC activities. The department shall not have access to personal information of registrants unless such access is required for the department's oversight responsibilities.

Part III
Use and Dissemination of Registry Information

12VAC5-475-80. Use.

The designees of accredited organ procurement organizations, eye banks, and tissue banks and all other persons with authorized access to the registry shall have an organizational or individual pass code, or both, assigned by the VTC to gain entry to the registry via the VTC website.

Once entry to the registry has been established, the designees shall enter the decedent's full name, the decedent's date of birth, the decedent's driver's license number, the decedent's unique identification number, or any combination thereof, to verify whether the decedent made a donor designation in the registry. Once the decedent's donor designation has been verified, the designees shall include the intent to donate document of gift as part of the donor record maintained by the accredited organ procurement organization, eye bank, and tissue bank.

If the decedent is not in the registry, the designees shall exit the registry. Designees shall not perform a search of the registry on any other person other than the decedent.

12VAC5-475-90. Dissemination.

The accredited organ procurement organizations, eye banks, and tissue banks with authorized access to the registry may disclose the contents of the decedent's documented donation designation document of gift to the decedent's next of kin, the nearest available relative, a member of the decedent's household, an individual with an affinity relationship, and the primary treating physician decedent's physicians, and any other person or entity specified in §§ 32.1-291.9 and 32.1-291.11 of the Code of Virginia, in order to demonstrate that the decedent's wish to donate decedent made an anatomical gift in accordance with §§ 32.1-290 the Revised Uniform Anatomical Gift Act (§ 32.1-291.1 et seq. of the Code of Virginia), § 46.2-342 of the Code of Virginia, 54.1-2984, and 54.1-2986 or an advance directive executed pursuant to the Health Care Decisions Act (§ 54.1-2981 et seq. of the Code of Virginia).

The VTC may disclose to the DMV the donor designation on those persons who are recorded in the registry in order that the driver's record accurately reflect those persons' wishes to donate pursuant to subsections E and F of § 46.2-342 of the Code of Virginia.

NOTICE: The following forms used in administering the regulation were filed by the agency. The forms are not being published; however, online users of this issue of the Virginia Register of Regulations may click on the name of a form with a hyperlink to access it. The forms are also available from the agency contact or may be viewed at the Office of the Registrar of Regulations, General Assembly Building, 2nd Floor, Richmond, Virginia 23219.

FORMS (12VAC5-475)

Virginia Organ and Tissue Donor Registry Removal Form, VTC-0 (eff. 7/00).

Virginia Organ and Tissue Donor Registry Form, VTC-1 (eff. 7/00).

Registry Removal Form, Donate Life Virginia (undated)

VA.R. Doc. No. R08-1335; Filed November 26, 2013, 10:09 a.m.