N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 52-11.4

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

Section 52-11.4 - Retrieval and acquisition of nontransplant anatomic parts

(a) The retrieval of nontransplant anatomic parts shall only be performed on:

(1) the premises of a general hospital;

(2) the premises of a whole body acquisition service licensed in accordance with this Subpart; or

(3) for nontransplant anatomic parts other than whole bodies and body segments, the premises of a comprehensive tissue procurement service licensed in accordance with Subpart 52-2 of this Part.

(b) No body, body segment, or other nontransplant anatomic part shall be retrieved, acquired, distributed, transported, or used for a purpose not authorized by Public Health Law section 4302. For the purposes of this Subpart, the term research as used in Public Health Law section 4302 shall be limited to research conducted in accordance with accepted research protocols designed to improve the public health, safety and welfare.

(c) Whole body acquisition services.

(1) A whole body acquisition service shall employ the following staff:

(i) a nontransplant anatomic bank director who holds a graduate degree in anatomy or the health sciences, or who has been serving as director of a nontransplant anatomic bank licensed by the department prior to the adoption of this provision;

(ii) an appropriately trained technician, morgue attendant, diener, or licensed funeral director responsible for the preparation, care and maintenance of whole bodies and body segments; and

(iii) at least one support staff person, other than the nontransplant anatomic bank director, but who may be the technician, morgue attendant, diener, or licensed funeral director, who shall be responsible for recordkeeping.

(2) Facilities requirements. A whole body acquisition service shall have a dedicated, secure and restricted space for preparation of whole bodies and body segments for research and/or education purposes. Access to such space shall be limited to individuals directly associated with receipt and preparation of whole bodies or body segments. Preparation and storage space shall include:

(i) a working sink and adequate counter space for preparation of whole bodies or body segments;

(ii) suitable space for storage of chemicals/materials used in preparation of whole bodies or body segments, as applicable;

(iii) counters, tables, and cabinetry built of material that may be easily disinfected and cleaned;

(iv) a refrigerated storage room, walk-in cooler, or cadaver drawer cooler, dedicated solely to storage of whole bodies or body segments. Such storage areas shall have lockable access doors, and alarms to signal intrusion or unacceptable temperature deviation;

(v) a U.S. Occupational Safety and Health Administration (OSHA)-approved device for handling, lifting, and internal transportation of whole bodies or body segments;

(vi) OSHA-approved eye wash stations;

(vii) if embalming is performed, a morgue compliant with Federal and State standards; and

(viii) if cremation is performed, a crematory compliant with Federal and State standards.

(3) Records. In addition to the records required in section 52-2.9(i) of this Part, a whole body acquisition service shall maintain complete and accurate records of all donations, including:

(i) identification of the whole body, and, in the case of a body segment, a description and source of the body segment;

(ii) documentation of unclaimed acquisitions, death certificates, and burial transit permits associated with receipt and use of whole bodies or body segments;

(iii) facilities/institutions to which the whole bodies or body segments are transferred, or documentation of any other disposition; and

(iv) a copy of any contract or letter of agreement between the whole body acquisition service and the whole body user, and documentation of the method of intended final disposition of the whole body or body segment.

(d) Transfer.

(1) Any transfer of whole bodies, body segments or other nontransplant anatomic parts shall be conducted in compliance with existing state standards for such transfer. The burial transit permit(s) issued by the registrar of vital statistics (in the case of a whole body transfer), or written documentation of the source and a description of the body segment(s) or anatomic parts, shall accompany whole bodies, body segments, or nontransplant anatomic parts.

(2) In the case of a whole body transfer, a copy of the properly executed burial transit permit shall be maintained by the whole body acquisition service.

N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 52-11.4