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<regulation prefix="Regulation" num=".05" citation="COMAR 10.51.07.05" title_num="10" subtitle_num="51" chapter_num="07" heading="Departmental Action — Reporting Erroneous Test Results.">
  <paragraph num="A.">
    <text>If the Department determines that a licensee has reported an erroneous test result that threatens the safety or rights of an individual, the Secretary may order the licensee, within a specified period of time, to:</text>
    <paragraph num="(1)">
      <text>Give prompt notice of the erroneous test result to:</text>
      <paragraph num="(a)">
        <text>The person who ordered the forensic analysis be performed;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Any other person to whom the forensic laboratory has previously sent a report that contained the erroneous test result;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>The Office of Public Defender or counsel of record; and</text>
      </paragraph>
      <paragraph num="(d)">
        <text>The State’s Attorney;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Provide corrected reports to the persons notified in §A(1) of this regulation;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Maintain a duplicate copy of both the original report and the corrected report;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Conduct a quality assessment of all phases of the testing or examination process to determine the cause of the erroneous forensic analysis test result;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Take the necessary remedial or corrective action to prevent recurrence of the problem; and</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Take any additional measures necessary to reduce or eliminate the threat to public safety or individual rights.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Civil Money Penalty for Failure to Comply with Order.</text>
    <paragraph num="(1)">
      <text>A forensic laboratory that fails to comply with an order issued by the Secretary under §A of this regulation is subject to a civil money penalty of up to $1,000 for each day of noncompliance, up to a maximum of $50,000.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The Secretary may impose the civil money penalty instead of, or in addition to, any other sanction imposed under this chapter.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Notice and Hearing.</text>
    <paragraph num="(1)">
      <text>Notice. Before the Secretary imposes a civil money penalty for noncompliance as provided in §B of this regulation, the Secretary shall give written notice to a licensee:</text>
      <paragraph num="(a)">
        <text>Of the intent to impose a civil money penalty; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>That the licensee has an opportunity for a hearing on the matter before the civil money penalty is imposed.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Content. The Secretary shall give written notice to the licensee of the:</text>
      <paragraph num="(a)">
        <text>Reason for the imposition of the civil money penalty;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Amount of the civil money penalty;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Effective date of the imposition of the civil money penalty;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Time allowed for the licensee to respond to the notice; and</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Authority for imposing the civil money penalty.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>Opportunity to Respond. During the time allowed and stated in the written notice from the Secretary, the licensee may submit to the Secretary written evidence or other information to support the position that the licensee has not violated the requirements of this subtitle or Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland.</text>
    </paragraph>
    <paragraph num="(4)">
      <text>To preserve the right to a hearing, the licensee shall request a hearing within 10 days of receipt of the notice of the Secretary’s intent to impose the civil money penalty.</text>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>Factors to Be Considered in the Assessment of Penalties. In cases in which the Secretary determines that the imposition of a civil money penalty is appropriate, the Secretary shall consider the following factors in determining the amount of the penalty:</text>
    <paragraph num="(1)">
      <text>The extent to which the licensee derived any financial or other benefit from reporting erroneous forensic analysis results;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The willfulness on the part of the licensee to violate this subtitle or Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>The extent of actual or potential harm caused by the reporting of erroneous forensic analysis results;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>The cost of investigating and prosecuting the case against the licensee;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>The licensee’s history of previous failure to meet the standards of this subtitle; and</text>
    </paragraph>
    <paragraph num="(6)">
      <text>The existence of mitigating factors.</text>
    </paragraph>
  </paragraph>
</regulation>