<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".06" citation="COMAR 10.51.05.06" title_num="10" subtitle_num="51" chapter_num="05" heading="Calibration — General.">
  <paragraph num="A.">
    <text>A licensee shall develop, establish, implement, maintain, and follow calibration procedures.</text>
    <paragraph num="(1)">
      <text>If computers or automated equipment are used for the processing, recording, reporting, storage, or retrieval of calibration data, the licensee shall ensure that:</text>
      <paragraph num="(a)">
        <text>Computer software is performance checked after updates occur or validated;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Procedures are established, maintained, and followed to protect and secure the data; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Computers and automated equipment are maintained to ensure proper functioning.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>A licensee shall ensure that:</text>
      <paragraph num="(a)">
        <text>Reference standards are calibrated by an entity that can provide traceability;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Measuring devices including rulers, weights, pipettes, balances, thermometers, and other devices that affect a forensic analysis result are calibrated against a reference standard traceable to the International System of Units, if available, as required by the manufacturer or forensic laboratory’s quality assurance program;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Calibration, if applicable, is performed:</text>
        <paragraph num="(i)">
          <text>Before initial use and before the recalibrated item is returned to service;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Following service or maintenance; and</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>At intervals specified by the manufacturer or more frequently as determined by the technical leader or quality assurance manager; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(d)">
        <text>All calibration activities are documented.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Postmortem Forensic Toxicology. In addition to applicable sections of this regulation, a laboratory performing postmortem forensic toxicology shall:</text>
    <paragraph num="(1)">
      <text>Include in the method calibration:</text>
      <paragraph num="(a)">
        <text>A sufficient number of calibrators and quality control samples in each batch that are consistent with the analysis being performed; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Analyses being performed on unusual specimens that:</text>
        <paragraph num="(i)">
          <text>Use appropriate matrix-matched calibrators, when possible; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Are prepared and tested concurrently with the specimen; and</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Have a policy that defines a specimen that has a unique matrix.</text>
    </paragraph>
  </paragraph>
</regulation>