<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".07" citation="COMAR 10.50.01.07" title_num="10" subtitle_num="50" chapter_num="01" heading="Accredited Tissue Bank and Accrediting Organization.">
  <paragraph num="A.">
    <text>Accredited Tissue Bank — Determination. The Secretary may accept as compliance with the inspection requirements of this chapter a tissue bank accredited by an organization approved by the Secretary, as set forth in §C of this regulation, if the OHCQ determines that the standards of the tissue bank accrediting organization are equivalent to those under this chapter.</text>
  </paragraph>
  <paragraph num="B.">
    <text>Accredited Tissue Bank — Requirements. In addition to meeting the requirements for accreditation, as set forth by a tissue bank's accrediting organization, an accredited tissue bank shall:</text>
    <paragraph num="(1)">
      <text>Obtain and maintain a valid permit issued by the Secretary; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Be subject to inspection by the OHCQ to:</text>
      <paragraph num="(a)">
        <text>Determine if the tissue bank is operating in a manner that does not constitute an imminent and serious risk to public health;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Investigate complaints;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Determine whether a permit holder is operating a tissue bank beyond the scope of the permit;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Validate findings of a tissue bank's accrediting organization; and</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Verify compliance with licensure requirements.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Accrediting Organization.</text>
    <paragraph num="(1)">
      <text>A private, nonprofit tissue-bank accrediting organization may inspect and accredit tissue banks in the State for the purpose of a State permit only after applying for and receiving approval of the OHCQ.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The OHCQ may approve a tissue bank accrediting organization based on a review of that organization, if the review includes (but need not be limited to) an evaluation of:</text>
      <paragraph num="(a)">
        <text>Accreditation policies and standards;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Copies of inspection forms and guidelines;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Inspection and deficiency writing policies;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Inspector qualifications; and</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Complaint investigation policies.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>In addition to other requirements set forth in this chapter, an accrediting organization shall provide to the OHCQ:</text>
      <paragraph num="(a)">
        <text>Annually, an updated list containing the names, addresses, and accreditation expiration dates of all tissue banks in the State accredited by the accrediting organization;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Within 30 days after conducting an inspection, a certified written or electronic copy of each inspection report covering each tissue bank applying for or maintaining accreditation in the State;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>At least 30 days before the effective date of the change, written notice of any proposed change to requirements for tissue bank accreditation;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Within 30 days after a tissue bank's accreditation expires, written or electronic notice if the tissue bank does not renew its accreditation;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Documentation of a complaint and complaint investigation; and</text>
      </paragraph>
      <paragraph num="(f)">
        <text>On request, a copy of:</text>
        <paragraph num="(i)">
          <text>Inspector qualifications; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Other information the Secretary may require relating to the regulation of a tissue bank.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>When the Secretary denies accreditation to a tissue-bank accrediting organization, the Secretary shall inform the accrediting agency in writing that it has an opportunity for a hearing under State Government Article, §10-226, Annotated Code of Maryland.</text>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>Change in Accreditation Status. Tissue banks shall report all changes in accreditation status to the OHCQ within seven calendar days of becoming aware of the change.</text>
  </paragraph>
</regulation>