Administrative Code

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Virginia Administrative Code
Title 12. Health
Agency 5. Department of Health
Chapter 410. Regulations for the Licensure of Hospitals in Virginia

12VAC5-410-220. Organ donation.

A. The hospital shall develop and implement a routine contact protocol for organ, tissue and eye donation in compliance with federal law and the regulations of the Centers for Medicare and Medicaid Services (CMS), particularly 42 CFR 482.45.

B. The protocol shall:

1. Ensure that the hospital collaborates with its designated organ procurement organization (OPO) to inform the family of each potential donor of the option of organ, tissue, and eye donation as well as the option to decline to donate;

2. Recite provisions of § 32.1-290.1 of the Code of Virginia specifying family members who are authorized to make an anatomical gift of all or part of the decedent's body for an authorized purpose and the order of priority of those family members who may make such gift; and

3. Include written procedures for organ, tissue, and eye donation. The procedures shall include:

a. Training of staff in organ, tissue, or eye donation;

b. A mechanism for informing the next of kin of the organ, tissue, and eye donation option;

c. Procedures to be employed when the hospital, consistent with the authority granted by § 32.1-292.1 of the Code of Virginia, deems it appropriate to conduct a reasonable search for a document of gift or other information identifying the bearer as a donor or as an individual who has refused to make an anatomical gift;

d. Provisions for the procurement and maintenance of donated organs, tissues, and eyes;

e. The name and telephone number of the local organ procurement agency, tissue or eye bank to be notified of potential donors; and

f. Documentation of the donation request in the patient's medical record.

C. The hospital shall have an agreement with an OPO certified by CMS:

1. To notify the OPO in a timely manner of all deaths or imminent deaths of patients in the hospital; and

2. Authorizing the OPO to determine the suitability of the decedent or patient for organ donation and the suitability for tissue and eye donation in the absence of a similar arrangement with any eye bank or tissue bank in Virginia certified by the Eye Bank Association of America or the American Association of Tissue Banks.

D. The hospital shall have an agreement with at least one tissue bank and at least one eye bank to cooperate in the retrieval, processing, preservation, storage, and distribution of tissues and eyes to ensure that all usable tissues and eyes are obtained from potential donors and to avoid interference with organ procurement.

E. The individual making contact with the family shall have completed a course in the methodology for approaching potential donor families and requesting organ or tissue donation that:

1. Is offered or approved by the OPO and designed in conjunction with the tissue and eye bank community; and

2. Encourages discretion and sensitivity according to the specific circumstances, views, and beliefs of the relevant family.

F. The hospital shall work cooperatively with its designated OPO in educating its staff on:

1. Donation issues;

2. The proper review of death records to improve identification of potential donors; and

3. The proper procedures for maintaining potential donors while necessary testing and placement of potential donated organs, tissues, and eyes take place.

G. The protocol shall be followed, without exception, unless the family of the relevant decedent or patient expresses opposition to organ donation, the chief administrative officer of the hospital or his designee knows of such opposition, and no donor card or other relevant document, such as an advance directive, can be found.

Statutory Authority

§§ 32.1-12 and 32.1-127 of the Code of Virginia.

Historical Notes

Derived from VR355-33-500 § 2.6, eff. July 28, 1993; amended, Virginia Register Volume 11, Issue 8, eff. April 1, 1995; Volume 17, Issue 1, eff. October 27, 2000; Volume 23, Issue 10, eff. March 1, 2007.

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