<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".16" citation="COMAR 30.08.06.16" title_num="30" subtitle_num="08" chapter_num="06" heading="Allograft Service.">
  <text>A burn center shall:</text>
  <paragraph num="A.">
    <text>Maintain a written policy stating:</text>
    <paragraph num="(1)">
      <text>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</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Compliance with U.S. Food and Drug Administration regulations published in 21 CFR Part 1270 Human Tissue Intended for Transplantation;</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>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</text>
  </paragraph>
  <paragraph num="C.">
    <text>Ensure that the operative notes and record support the documentation of all allograft transplants.</text>
  </paragraph>
</regulation>