New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter C - Access To Records › Part 52 - Tissue Banks And Nontransplant Anatomic Banks › Subpart 52-2 - Tissue Banks And Nontransplant Anatomic Banks-licensure › Section 52-2.9 - Required records

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
					 Complete and accurate records of tissue and nontransplant anatomic parts
					 released shall be kept by the tissue banks or nontransplant anatomic banks
					 distributing the tissue. Such records shall be open to inspection by the
					 department. For all donated tissue and nontransplant anatomic parts, the
					 donor's name, address, and any other information which would directly or
					 indirectly identify the donor shall not be disclosed or released by the bank to
					 any person or entity, except upon the written consent of the donor or the
					 person authorized by law to make the donation, or to authorized employees of
					 the department, or as permitted by law. The recipient's name, address, and any
					 other information which would directly or indirectly identify the recipient
					 shall not be disclosed or released by the tissue bank to any person or entity,
					 except upon the written consent of the recipient, or except to authorized
					 employees of the department. or as permitted by law.
(b) Complete and accurate records of tissue
					 and nontransplant anatomic parts released for transplantation, transfer,
					 artificial insemination, implantation, research and education shall be kept by
					 the tissue transplantation facility or insemination/implantation site. Such
					 records shall be open to inspection by the department and shall be kept for at
					 least seven years after transplantation or six months after the expiration date
					 of the tissue, whichever is longer. In cases of reproductive tissue
					 transfer/artificial insemination/implantation, records shall be kept for at
					 least seven years after the release of tissue not resulting in live births and
					 25 years for tissue resulting in live births. Nontransplant anatomic banks
					 shall retain records for five years after release of nontransplant anatomic
					 parts for research or education purposes. The recipient's name, address, and
					 any other information which would directly or indirectly identify the recipient
					 shall not be disclosed or released by the tissue transplantation facility or
					 insemination/implantation site to any person or entity, except upon the written
					 consent of the recipient, or except to authorized employees of the department,
					 or as permitted by law.
(c) The
					 following donation records shall be kept by each comprehensive tissue
					 procurement service:
(1) donor's full name,
					 address at time of donation, identification code, date of birth or age, and
					 date and time of death, if a cadaveric donor;
(2) documentation of evaluation of physical
					 condition, if a cadaveric donor;
(3) pertinent donor medical history,
					 including, but not limited to, autopsy reports, donation questionnaires, and
					 other donor solicitation materials;
(4) documentation of donor informed consent
					 or consent of the person authorized by law to consent to the donation, if
					 applicable, including such person's address, unless this record is retained by
					 a limited tissue procurement service;
(5) date and time of collection, and
					 description and quantity of tissue retrieved;
(6) any reported changes in donor health
					 status, if applicable;
(7) outcome
					 of transplantation, transfer, artificial insemination and implantation
					 procedures, if known, and any reports from facilities using the tissue, which
					 would affect the donor's acceptability;
(8) records specified in the Subpart specific
					 to each category of tissue; and
(9)
					 documentation of staff training, certification and continuing
					 education.