Regulation .16 Allograft Service.
Regulation .16 Allograft Service.LinkCopy Citation
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.