N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 52-6.5

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

Section 52-6.5 - Retrieval of tissue

(a) Skin shall be retrieved using aseptic technique in an operating room or other aseptic premises approved by the tissue bank medical director. In all cases, a vigorous surgical scrub and disinfectant solution nontoxic to epithelial cells shall be used in preparing the donation site for skin retrieval in accordance with standard operating room practice.

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

(d) Skin specimen containers and packaging materials shall be sterile and nontoxic.

(e) Each skin 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.

(f) Fresh-cut skin shall be maintained in a sterile, isotonic solution or other nutrient medium during the skin removal procedure, and transported to the tissue processing facility at the completion of the procedure.

(g) Skin samples for testing for microbial contamination shall be recovered from each anatomical site and placed in a separate, appropriately labeled container.

(h) Skin and blood specimen containers shall be labeled so as to maintain 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 §§ 52-6.5