N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 52-5.5

Current through Register Vol. 46, No. 50, December 11, 2024

Section 52-5.5 - Retrieval of tissue

(a) Musculoskeletal tissue, including tissue for which assurance of sterility cannot be maintained, such as mandible, shall be retrieved using aseptic technique in an operating room or other aseptic premises approved by the tissue bank medical director.

(b) Retrieval of musculoskeletal tissue from cadaveric donors shall occur within a time limit after cessation of cardiac function specified in written policies approved by the medical director of the comprehensive tissue procurement service.

(c) Musculoskeletal tissue retrieved from cadaveric donors shall be transported to the tissue processing facility at a temperature of 10 degrees Celsius or lower.

(d) If an ante mortem blood sample is not available from a cadaveric donor, a post mortem sample of sufficient quantity to perform required laboratory testing shall be drawn via a cardiac insertion or from a large vein or artery.

(e) Tissue specimen containers and packaging materials shall be sterile and nontoxic.

(f) Each tissue and blood specimen container shall be labeled legibly at the time of retrieval with the tissue bank identification, and donor identification code or unique tissue identification number. The date, time and anatomic site of retrieval shall be recorded on accompanying documents.

(g) A segment or sample of musculoskeletal tissue that is not intended for viral inactivation shall be placed in a separate, appropriately labeled sterile container intended for culturing for aerobic and anaerobic contamination.

(h) Tissue and blood specimen containers shall be labeled so as to maintain musculoskeletal tissue identification throughout all phases of processing, storage and distribution, in a manner not subject to significant deterioration under conditions of transport and storage.

N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 52-5.5