N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 52-4.3

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

Section 52-4.3 - Tissue procurement services

(a) A facility that engages in donor selection and solicitation, and retrieval of cardiovascular tissue shall be licensed by the department as a comprehensive tissue procurement service.

(b) A facility whose tissue acquisition activities are limited to donor selection and solicitation by its own staff shall be licensed by the department as a limited tissue procurement service.

(c) Comprehensive tissue procurement services retrieving cardiovascular tissue from cadaveric donors shall maintain written standard operating procedures that assure that the retrieval environment, including, but not limited to, walls, floors and permanent equipment, is suitable for retrieval and adequate to prepare an aseptic field. A working sink shall be available.

(d) Cardiovascular tissue retrieval shall be performed only by trained retrieval technicians under the supervision of the director of a licensed comprehensive tissue procurement service. The director of the licensed comprehensive tissue procurement service shall be responsible for developing policies, procedures and standards for the educational background, training, certification and continuing education of retrieval technicians. Documentation of compliance with this requirement and the standards developed shall be maintained.

N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 52-4.3