Md. Code Regs. 30.08.06.16

Current through Register Vol. 51, No. 25, December 13, 2024

Section 30.08.06.16 - Allograft Service

A burn center shall:

A. Maintain a written policy stating:

(1) That allograft tissues are to be obtained only from those tissues banks that adhere to the standards of the American Association of Tissue Banks, if applicable; and

(2) Compliance with U.S. Food and Drug Administration regulations published in 21 CFR Part 1270 Human Tissue Intended for Transplantation;

B. Develop and implement policies and procedures related to obtaining, storing, and handling of homograft and heterograft skin, if the use of biological membranes is a component of care provided by the burn center in compliance with the Joint Commission standards; and

C. Ensure that the operative notes and record support the documentation of all allograft transplants.

Md. Code Regs. 30.08.06.16

Regulation .16 adopted effective 47:5 Md. R. 313, eff. 7/1/2020