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<regulation prefix="Regulation" num=".01" citation="COMAR 10.51.07.01" title_num="10" subtitle_num="51" chapter_num="07" heading="Sanctions — General.">
  <paragraph num="A.">
    <text>Authority and Types.</text>
    <paragraph num="(1)">
      <text>The Secretary may impose one or more principal or alternative sanctions if a forensic laboratory or the laboratory’s director or other employees fail to meet the standards of this subtitle and Health–General Article, Title 17, Subtitle 2A, Annotated Code of Maryland.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Principal Sanctions. The Secretary may impose the following principal sanctions:</text>
      <paragraph num="(a)">
        <text>Denial of a license;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Suspension of a license; or</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Revocation of a license.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>Alternative Sanctions. Instead of or in conjunction with withdrawing a principal sanction, the Secretary may impose one or more of the following alternative sanctions:</text>
      <paragraph num="(a)">
        <text>A directed plan of correction;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Limitation on forensic analyses; or</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Training and technical assistance.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Reasons for Imposition. The Secretary may impose on a forensic laboratory one or more sanctions if the Secretary finds:</text>
    <paragraph num="(1)">
      <text>A deficiency identified through:</text>
      <paragraph num="(a)">
        <text>An on-site audit; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>A review of materials submitted by a forensic laboratory that shows a problem with:</text>
        <paragraph num="(i)">
          <text>Application data;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Employee qualification materials; or</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Internal audits;</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Unsuccessful proficiency test performance;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Demonstrated incompetence, such as showing consistent or repetitive errors in:</text>
      <paragraph num="(a)">
        <text>Operating forensic laboratory equipment; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Performing a forensic analysis;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>False statements made on an application, allegation of compliance, or other form submitted to the Department;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Misrepresentation in obtaining a license or in operating a forensic laboratory;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Submission of a sample or specimen by a forensic laboratory inside the State to another laboratory that does not possess a license or a waiver as set forth in this subtitle; or</text>
    </paragraph>
    <paragraph num="(7)">
      <text>A violation of a law of the State pertaining to a forensic laboratory.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Factors Affecting Choice of Sanctions. The Secretary shall choose which sanctions to apply to a forensic laboratory based on, but not limited to, the following:</text>
    <paragraph num="(1)">
      <text>Whether a deficiency poses immediate jeopardy to public safety or individual rights;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The nature, incidence, severity, and duration of the deficiency;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Whether a deficiency has been identified repeatedly;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Whether the Department can determine the laboratory’s compliance due to inaccurate record keeping or the licensee’s lack of documentation or laboratory records, including those required for quality assurance and quality control;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Failure to make records available to the Department;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>The relationship of one deficiency or group of deficiencies to another deficiency;</text>
    </paragraph>
    <paragraph num="(7)">
      <text>The overall compliance history of a forensic laboratory, including but not limited to any period of noncompliance that occurred between the Secretary’s determinations of compliance;</text>
    </paragraph>
    <paragraph num="(8)">
      <text>The corrective and long-term compliance outcomes the Secretary intends to effect through application of the sanction; and</text>
    </paragraph>
    <paragraph num="(9)">
      <text>The progress a forensic laboratory has made toward regulatory compliance following a reasonable opportunity to correct a deficiency.</text>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>Improper Referral of Proficiency Testing Samples. If the Department determines that a forensic laboratory has intentionally referred a proficiency testing sample to another laboratory for analysis, the Secretary:</text>
    <paragraph num="(1)">
      <text>Shall revoke the forensic laboratory’s license for a period of 1 year; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>May also impose one or more alternative sanctions.</text>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>Owning and Operating Prohibition Following Revocation. A person who has owned, operated, or directed a forensic laboratory that has had the laboratory’s license revoked may not, within 1 year of the revocation, apply for a license for or own, operate, or direct a forensic laboratory.</text>
  </paragraph>
</regulation>