N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 52-3.3

Current through Register Vol. 46, No. 45, November 2, 2024

Section 52-3.3 - Qualifications of donors

(a) A comprehensive or limited tissue procurement service shall obtain a signed informed consent from the living donor of tissue for clinical use.

(b) For potential cadaveric donors who have not left a signed, witnessed organ/tissue donor card (see section 4303 of the Public Health Law) or a will, the procurement service shall obtain informed consent to an anatomical gift from the next of kin or guardian of the decedent, as required by section 405.25 of this Title, before retrieving tissue. Informed consent forms shall clearly specify the tissues and/or nontransplant anatomic parts to be retrieved. Consent obtained by telephone shall be recorded or documented in writing by the tissue procurement service requesting the donation.

(c) The acceptability of a cadaveric donation shall be determined by medical history information obtained from medical records, attending physicians on other health care professionals, and from interviewing a family member and/or other person close to the decedent. In the event that no family member or other person close to the decedent is available, eye tissue may be accepted, providing that the final tissue container or accompanying paperwork is clearly labeled to alert the transplanting surgeon that such interview was not conducted. An evaluation of the donor's condition shall be made by a qualified tissue retrieval team member, including an examination for signs of injected drug use, infection, or trauma at the site of donation that may affect the quality of the donated tissue.

(d) The acceptability of a donation from a living donor shall be determined by a physical examination of and health history interview with the donor.

(e) A trained, qualified supervisor shall determine whether a donor is suitable for tissue retrieval on the day of the retrieval, according to criteria developed by the medical director in consultation with the medical advisory committee. The medical director, as defined in Subpart 52-1 of this Part, shall be responsible for determining whether:

(1) the living donor and his/her donated tissue are acceptable, prior to the retrieval of the tissue, according to criteria developed by the medical director in consultation with the medical advisory committee; and

(2) the cadaveric donor and his/her donated tissue are acceptable, prior to the release of tissue, according to criteria developed by the medical director in consultation with the medical advisory committee.

N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 52-3.3