Chapter 475. Regulations Implementing the Virginia 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:
"Anatomical gift" or "organ donation" means a donation of 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.
"Decedent" means a deceased individual 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 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 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.
"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 whose body or part is the subject of an anatomical gift.
"Eye bank" means 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 a court 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.
"Organ procurement organization" means 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, an eye, or tissue of a human being. The term does not include the whole body.
"Procurement" means the recovery of any donated part by a licensed physician or a technician who is qualified in accordance with § 32.1-291.14 of the Code of Virginia.
"Registry" means the Virginia Donor Registry, which shall be 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.
"Tissue bank" means 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.
"VTC" means the Virginia Transplant Council.
Statutory Authority
§ 32.1-292.2 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 18, Issue 12, eff. March 27, 2002; amended, Virginia Register Volume 31, Issue 22, eff. July 31, 2015.
12VAC5-475-20. (Repealed.)
Historical Notes
Derived from Virginia Register Volume 18, Issue 12, eff. March 27, 2002; repealed, Virginia Register Volume 31, Issue 22, eff. July 31, 2015.
12VAC5-475-30. Administration.
A. The VTC, as authorized by the board pursuant to § 32.1-292.2 D 2 of the Code of Virginia, 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.
B. All persons responsible for the administration of the 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.
Statutory Authority
§ 32.1-292.2 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 18, Issue 12, eff. March 27, 2002; amended, Virginia Register Volume 31, Issue 22, eff. July 31, 2015.
12VAC5-475-40. (Repealed.)
Historical Notes
Derived from Virginia Register Volume 18, Issue 12, eff. March 27, 2002; repealed, Virginia Register Volume 31, Issue 22, eff. July 31, 2015.
Part II
Registry Information
12VAC5-475-50. Registry membership.
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 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 interagency agreement, the Department of Motor Vehicles will assist the department by electronically providing this information to the registry on a regular basis as agreed upon by the Department of Motor Vehicles and the VTC. 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.
Statutory Authority
§ 32.1-292.2 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 18, Issue 12, eff. March 27, 2002; amended, Virginia Register Volume 31, Issue 22, eff. July 31, 2015.
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), 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, address, and unique identification number of the donor's parent or legal guardian shall be recorded.
Statutory Authority
§ 32.1-292.2 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 18, Issue 12, eff. March 27, 2002; amended, Virginia Register Volume 31, Issue 22, eff. July 31, 2015.
12VAC5-475-70. Removal from the registry.
A. A person who has joined the registry may amend his anatomical gift or revoke the anatomical gift by filing an appropriate form with the VTC in accordance with the Revised Uniform Anatomical Gift Act (§ 32.1-291.1 et seq. of the Code of Virginia) or subsection 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 Division of Vital Records and Health Statistics.
Statutory Authority
§ 32.1-292.2 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 18, Issue 12, eff. March 27, 2002; amended, Virginia Register Volume 31, Issue 22, eff. July 31, 2015.
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.
Statutory Authority
§ 32.1-292.2 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 31, Issue 22, eff. July 31, 2015.
12VAC5-475-80. Use.
The designees of 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 website.
Once entry to the registry has been established, the designees shall enter the decedent's full name, date of birth, driver's license number, 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 document of gift as part of the donor record maintained by the organ procurement organization, eye bank, and tissue bank.
If the decedent is not in the registry, the designees shall exit the registry.
Statutory Authority
§ 32.1-292.2 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 18, Issue 12, eff. March 27, 2002; amended, Virginia Register Volume 31, Issue 22, eff. July 31, 2015.
12VAC5-475-90. Dissemination.
The organ procurement organizations, eye banks, and tissue banks with authorized access to the registry may disclose the contents of the decedent's 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, the 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 made an anatomical gift in accordance with 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, or an advance directive executed pursuant to the Health Care Decisions Act (§ 54.1-2981 et seq. of the Code of Virginia).
Statutory Authority
§ 32.1-292.2 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 18, Issue 12, eff. March 27, 2002; amended, Virginia Register Volume 31, Issue 22, eff. July 31, 2015.
Forms (12VAC5-475)