<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".02" citation="COMAR 10.51.02.02" title_num="10" subtitle_num="51" chapter_num="02" heading="Accredited Forensic Laboratory and Accrediting Organization.">
  <paragraph num="A.">
    <text>Accredited Forensic Laboratory — Determination. The Secretary shall accept as meeting the audit requirements of this subtitle a forensic laboratory accredited by an organization approved by the Secretary, as set forth in §C of this regulation, if the Department determines that the standards of the forensic laboratory’s accreditation organization are equivalent to those under this subtitle.</text>
  </paragraph>
  <paragraph num="B.">
    <text>Accredited Forensic Laboratory — Requirements. In addition to meeting the requirements for obtaining and maintaining a certificate of accreditation, as set forth by the forensic laboratory’s accrediting organization, an accredited forensic laboratory shall:</text>
    <paragraph num="(1)">
      <text>Obtain and maintain a valid license issued by the Department; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Be subject to audit by the Department as set forth in COMAR 10.51.02.03.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Accreditation Organization.</text>
    <paragraph num="(1)">
      <text>A private, nonprofit forensic laboratory accreditation organization may inspect and accredit forensic laboratories in the State for the purpose of State licensure only after applying for and receiving approval of the Department, as the Secretary’s designee.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The Department shall base approval of a forensic laboratory accreditation organization on a review of information provided by that organization, including but not limited to:</text>
      <paragraph num="(a)">
        <text>Data collection and data sharing and reporting policies;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Accreditation policies, procedures, and standards;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Assessment forms and guidelines;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Assessment and deficiency writing policies and procedures;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Assessor and technical expert qualifications;</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Complaint investigation policies and procedures;</text>
      </paragraph>
      <paragraph num="(g)">
        <text>Proficiency test monitoring policies and procedures; and</text>
      </paragraph>
      <paragraph num="(h)">
        <text>Procedures the accreditation organization will follow when notifying the Department that the accreditation organization:</text>
        <paragraph num="(i)">
          <text>Is denying, withdrawing, suspending, revoking, or otherwise limiting a forensic laboratory’s accreditation;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Finds serious jeopardy to individual rights or identifies a hazard to public safety;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Accredits a new forensic laboratory;</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Imposes an adverse or corrective action on a forensic laboratory; or</text>
        </paragraph>
        <paragraph num="(v)">
          <text>Is initiating a complaint investigation.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>In addition to requirements set forth elsewhere in this subtitle, an accreditation organization shall:</text>
      <paragraph num="(a)">
        <text>Provide to the Department:</text>
        <paragraph num="(i)">
          <text>Annually, an updated list containing the names, addresses, and accreditation expiration dates of forensic laboratories in the State that are accredited by the organization;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Within 30 days after conducting an assessment, a certified written or electronic copy of each assessment report covering each forensic laboratory applying for or maintaining accreditation in the State;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Written notice of any proposed change to requirements for forensic laboratory accreditation, at least 30 days before the effective date of the change;</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Within 10 days after a forensic laboratory’s certificate of accreditation expires, written or electronic notice when the forensic laboratory does not renew an accreditation certificate; and</text>
        </paragraph>
        <paragraph num="(v)">
          <text>Within 24 hours after taking an action, telephonic or electronic notice when an accredited forensic laboratory’s certificate of accreditation is suspended, revoked, surrendered, or otherwise limited;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>Evaluate compliance, when applicable, with State regulations pertaining to:</text>
        <paragraph num="(i)">
          <text>Forensic analyses;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Reporting of forensic analysis results as required by law or regulation; and</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Proficiency testing;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(c)">
        <text>Evaluate compliance with State regulations by:</text>
        <paragraph num="(i)">
          <text>Incorporating an evaluation of compliance with State regulatory requirements into the accreditation organization’s own assessment process; or</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Demonstrating that the accreditation organization’s existing assessment process adequately evaluates compliance with State regulations; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(d)">
        <text>On request, provide to the Department a copy of:</text>
        <paragraph num="(i)">
          <text>A complaint investigation;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Assessor qualifications;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>A change in a forensic laboratory’s forensic disciplines or subdisciplines; or</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Other information the Department may require relating to approval of a forensic laboratory accreditation organization.</text>
        </paragraph>
      </paragraph>
    </paragraph>
  </paragraph>
</regulation>