<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".11" citation="COMAR 10.51.05.11" title_num="10" subtitle_num="51" chapter_num="05" heading="Equipment Maintenance.">
  <paragraph num="A.">
    <text>General. The laboratory shall develop, establish, maintain, implement, and follow an equipment calibration and maintenance procedure and policy.</text>
  </paragraph>
  <paragraph num="B.">
    <text>A licensee shall ensure that equipment, before being placed into use, is calibrated or checked to establish that the equipment meets either the laboratory’s or manufacturer’s specifications, or both, as determined by the director.</text>
  </paragraph>
  <paragraph num="C.">
    <text>A licensee shall ensure that records are maintained on all items of equipment including at a minimum:</text>
    <paragraph num="(1)">
      <text>Identity of the item of equipment and the equipment’s ancillary parts;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Manufacturer’s name and serial number or other unique identifier;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Performance checks ensuring the equipment complies with the manufacturer’s specifications;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Current location, if applicable;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Manufacturer’s instructions or operating manual;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Dates and results of calibrations, adjustments, and service and date of next calibration;</text>
    </paragraph>
    <paragraph num="(7)">
      <text>Documentation of all maintenance performed, including date and signature of the individual performing the maintenance; and</text>
    </paragraph>
    <paragraph num="(8)">
      <text>Documentation of any damage, malfunction, modification, or repair to the equipment.</text>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>A licensee shall ensure that any equipment that gives questionable results or is not functioning properly is immediately taken out of use and the equipment:</text>
    <paragraph num="(1)">
      <text>Is clearly labeled as out of service;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Is examined and repaired or retired;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Is calibrated or shown to perform correctly before being put back into service; and</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Has forensic analysis results on previously examined evidence evaluated for accuracy back to the previous calibration.</text>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>A licensee shall ensure that the equipment, including both hardware and software, is safeguarded from adjustments that invalidate or alter calibrations or test examinations and analyses.</text>
  </paragraph>
  <paragraph num="F.">
    <text>A licensee shall ensure that operator’s manuals for all equipment and instruments are available to all examiners and analysts who use the equipment or instruments.</text>
  </paragraph>
</regulation>