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<regulation prefix="Regulation" num=".10" citation="COMAR 26.08.05.10" title_num="26" subtitle_num="08" chapter_num="05" heading="Laboratory Quality Assurance Program.">
  <paragraph num="A.">
    <text>Quality Assurance Manual.</text>
    <paragraph num="(1)">
      <text>Each certified water quality laboratory shall establish a quality assurance program consistent with U.S. Environmental Protection Agency Laboratory Certification Manual criteria or with TNI standards, if applicable.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>A water quality laboratory’s Quality Assurance Manual shall include a description of its quality assurance program.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>The quality assurance officer for a laboratory is responsible for maintaining the quality assurance manual.</text>
    </paragraph>
    <paragraph num="(4)">
      <text>A water quality laboratory shall submit its Quality Assurance Manual for review to the Department as part of the initial certification application.</text>
    </paragraph>
    <paragraph num="(5)">
      <text>A water quality laboratory shall submit in writing any revisions to a Quality Assurance Manual if there is a change in laboratory operations or if the Quality Assurance Manual is requested by the Department.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>An acceptable quality assurance program shall include the following:</text>
    <paragraph num="(1)">
      <text>A preventive maintenance program that ensures proper functioning of all instruments and equipment;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Regular operational checks and calibrations to assure proper operation and standardization of equipment, instruments, and reagents;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Routine testing of standard reference samples and other quality control materials. Quality control checks on reagents and media utilized in the performance of tests;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Maintenance of quality control records, which will support the reliability of all procedures performed and which shall be kept on file and readily available for a period of 5 years;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Satisfactory participation in a proficiency test program administered under NELAP or a TNI approved accredited proficiency test body, to be performed for every method and parameter requested for certification; and</text>
    </paragraph>
    <paragraph num="(6)">
      <text>The analysis of proficiency testing samples at a frequency necessary to evaluate the performance of any certified water quality laboratory.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>The water quality laboratory supervisor shall assure that a copy of the results of the proficiency testing analyses are forwarded directly to the Department from the approved proficiency test provider within 30 days of receipt.</text>
  </paragraph>
  <paragraph num="D.">
    <text>Proficiency Testing Evaluation.</text>
    <paragraph num="(1)">
      <text>If there is not a valid proficiency test for each parameter and test method combination for the review period, the Department shall downgrade the laboratory’s certification to a provisional status for the parameter and test method.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Provisional certification for a parameter and test method is valid for 90 days.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>If the laboratory does not submit passing proficiency test results within the review period, the Department may revoke or deny certification for the parameter or test method that does not have a valid proficiency test report.</text>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>Test results may not be reported on samples when quality control samples included in the analysis are found to be outside acceptable analytical limits. The entire batch of samples in the test run shall be retested and analytical data may not be reported unless quality control samples for the test run are within acceptable limits.</text>
  </paragraph>
  <paragraph num="F.">
    <text>The supervisor shall certify that each test or analysis is accurate and valid and that the test or analysis was performed in accordance with approved EPA methods for drinking water.</text>
  </paragraph>
</regulation>