Title: Section 52-4.13 - Tissue storage facilities

Effective Date

11/01/2000

52-4.13 Tissue storage facilities.

(a) A facility which stores cardiovascular tissue shall be licensed by the department as a tissue storage facility. The cardiovascular tissue bank shall keep the department fully informed of the number and type of tissue storage facilities operating under its direction.

(b) All cardiovascular tissue shall be stored and monitored in accordance with the provisions of sections 52-4.8, and 52-4.9(b), (c) and (d) of this Subpart.

(c) Temperature records or liquid nitrogen level records shall be available for inspection by the department for the entire period of cardiovascular tissue storage and for one (1) year afterwards.

(d) Cardiovascular tissue products shall be distributed in accordance with the requirements of this Part, and all records related to the inspection, distribution and transport of tissues shall be open to inspection by the department and shall be kept for at least seven (7) years or six (6) months after the expiration date of the tissue, whichever is the longer time.

Volume

VOLUME A-1 (Title 10)

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