<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".03" citation="COMAR 10.51.02.03" title_num="10" subtitle_num="51" chapter_num="02" heading="Audits.">
  <paragraph num="A.">
    <text>General.</text>
    <paragraph num="(1)">
      <text>A licensee shall allow an on-site audit by the Department and, when applicable, by the forensic laboratory’s accreditation organization, at any time during the forensic laboratory’s normal hours of operation, to evaluate the forensic laboratory’s compliance with the applicable requirements, conditions, and standards of this subtitle.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>An audit may include but is not limited to observation and examination of:</text>
      <paragraph num="(a)">
        <text>Laboratory facilities;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Equipment;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Quality assurance and quality control program records;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Operating procedures;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Employees;</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Employee records;</text>
      </paragraph>
      <paragraph num="(g)">
        <text>Proficiency testing;</text>
      </paragraph>
      <paragraph num="(h)">
        <text>Forensic analysis reports; and</text>
      </paragraph>
      <paragraph num="(i)">
        <text>Other records and files pertinent to this subtitle.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>Forensic laboratory employees shall make data and records accessible during an on-site audit.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Permitted Forensic Laboratory. A licensee operating a forensic laboratory under a permit shall:</text>
    <paragraph num="(1)">
      <text>Be subject to routine audits conducted by the Department;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Undergo a routine audit within 6 months after the forensic laboratory:</text>
      <paragraph num="(a)">
        <text>Begins operating;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Undergoes a change in ownership; or</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Has had a principal or alternative sanction imposed; and</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>Undergo a routine triennial audit after meeting the audit requirements set forth in §B(2) of this regulation.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Accredited Forensic Laboratory. An accredited forensic laboratory is:</text>
    <paragraph num="(1)">
      <text>Not subject to routine audits conducted by the Department as set forth in §B of this regulation if the accredited forensic laboratory is undergoing routine on-site assessment conducted by an accreditation organization approved by the Secretary, except as provided in §C(2) of this regulation; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Subject to audits conducted by the Department to:</text>
      <paragraph num="(a)">
        <text>Investigate a complaint;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Determine regulatory compliance with any quality requirement;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Follow up on any serious problem identified by an accreditation organization; or</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Validate an accreditation organization’s assessment of a forensic laboratory.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>Public Record.</text>
    <paragraph num="(1)">
      <text>A forensic laboratory shall make discrepancy logs, contamination records, test results, and final inspection reports, including deficiency statements and plans of correction, available to the public within 30 business days of a written request for these public documents.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Except as identified in this section or as otherwise provided by law, the proceedings, records, and files of an organization or State agency responsible for assuring compliance with this subtitle shall be confidential and may not be discoverable or admissible as evidence in a civil or criminal action.</text>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>Internal Audits.</text>
    <paragraph num="(1)">
      <text>A forensic laboratory shall conduct and document an annual audit of the overall operations of the forensic laboratory and generate a written audit report that identifies the finding and the corrective action taken to address the noncompliance.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The forensic laboratory shall:</text>
      <paragraph num="(a)">
        <text>Report the audit documentation to the Department within 4 months of the audit date;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Make the audit documentation available on-site for inspection by the Department or its designee;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Conduct an audit in each discipline in which the laboratory performs forensic analyses, using the quality assurance program policies, procedures, and protocols currently in use during the auditing cycle; and</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Conduct a comprehensive evaluation of the overall quality assurance program that includes both administrative and technical services.</text>
      </paragraph>
    </paragraph>
  </paragraph>
</regulation>