<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".02" citation="COMAR 10.51.05.02" title_num="10" subtitle_num="51" chapter_num="05" heading="Quality Assurance — Specific.">
  <paragraph num="A.">
    <text>Policies and Procedure.</text>
    <paragraph num="(1)">
      <text>A licensee shall develop, establish, maintain, implement, and follow quality assurance policies and procedures that ensure that the laboratory’s quality system is maintained.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>A licensee shall ensure that the laboratory has a clear procedure describing the process to uniquely identify evidence.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Chain of Custody. The licensee shall:</text>
      <paragraph num="(a)">
        <text>Maintain a record of chain of custody in written or electronic form in order to maintain accurate tracking of all evidence; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Document each transfer of evidence with the date of transfer and the signature of the person receiving the evidence at the time of transfer.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Identifying and Handling Evidence. A licensee shall:</text>
    <paragraph num="(1)">
      <text>Ensure that each item of evidence received by the forensic laboratory:</text>
      <paragraph num="(a)">
        <text>Is permanently marked and includes a unique identifier either on the:</text>
        <paragraph num="(i)">
          <text>Evidence itself; or</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Proximal container of the evidence; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>Has a documented record that includes the:</text>
        <paragraph num="(i)">
          <text>Identity of the evidence submitter;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Date the item of evidence was submitted; and</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Description of the item of evidence submitted;</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Establish and follow a procedure to identify evidence that cannot be marked or identified as set forth in §B(1) of this regulation;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Ensure all items produced during a forensic analysis or examination are:</text>
      <paragraph num="(a)">
        <text>Marked with a unique identifier that can be traced back to the original evidence;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Appropriately packaged;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Documented in case notes, reports, and the evidence tracking system; and</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Packed with the original evidence when applicable or a disposition will be noted;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>Ensure documentation of the date of receipt of each test item and evidence;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Establish, maintain, and follow a procedure to define proper packaging and sealing of evidence requiring that:</text>
      <paragraph num="(a)">
        <text>Evidentiary seals:</text>
        <paragraph num="(i)">
          <text>Are initialed or marked by the person sealing the evidence; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Prevent the evidence from being removed, lost, altered, or contaminated; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>Evidence is protected from:</text>
        <paragraph num="(i)">
          <text>Loss;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Cross-contamination; and</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Any harmful change; and</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(6)">
      <text>Consider evidence containers properly sealed only if:</text>
      <paragraph num="(a)">
        <text>The contents cannot readily escape; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Entering the container results in obvious damage or alteration to the container or the container’s seal.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Deficiencies, Errors, and Corrective Actions. A licensee shall have:</text>
    <paragraph num="(1)">
      <text>A procedure for corrective actions to be taken when a deficiency or error is identified with:</text>
      <paragraph num="(a)">
        <text>A forensic analysis procedure or method; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The casework or proficiency testing of a forensic analyst or examiner; and</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>The procedure and required documentation for the corrective actions include:</text>
      <paragraph num="(a)">
        <text>A determination of the cause of the deficiency or error;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>An evaluation of the deficiency or error to determine if the deficiency or error causes or has caused an adverse effect on the quality of a forensic analysis;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>An indication of the individual responsible for corrective action;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>A timeline of corrective action or actions; and</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Verification that the corrective action was:</text>
        <paragraph num="(i)">
          <text>Implemented; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Monitored for effectiveness in correcting the deficiency or error.</text>
        </paragraph>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>A licensee shall designate a quality assurance manager to oversee and ensure that the quality assurance program is implemented, maintained, and routinely evaluated.</text>
  </paragraph>
  <paragraph num="E.">
    <text>A licensee shall ensure that a change to an entry on an examination document, whether written or electronic, is:</text>
    <paragraph num="(1)">
      <text>Trackable to the person who made the change; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Not erased, hidden, obscured, disguised, or obliterated.</text>
    </paragraph>
  </paragraph>
  <paragraph num="F.">
    <text>A licensee shall establish and follow a procedure to document any:</text>
    <paragraph num="(1)">
      <text>Evidence discrepancies;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Compromise of evidence integrity; or</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Lost or misplaced evidence.</text>
    </paragraph>
  </paragraph>
  <paragraph num="G.">
    <text>A licensee shall document all quality assurance and quality control activities as set forth in this subtitle.</text>
  </paragraph>
  <paragraph num="H.">
    <text>A licensee shall establish a procedure to:</text>
    <paragraph num="(1)">
      <text>Investigate, resolve, and document a forensic analysis discrepancy; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Allow for a request and approval from the director or designee for a deviation from standard operating procedures.</text>
    </paragraph>
  </paragraph>
  <paragraph num="I.">
    <text>Public Record.</text>
    <paragraph num="(1)">
      <text>A licensee shall establish and follow a procedure to make discrepancy logs, contamination records, and test results available to the public within 30 days of a written request.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>A contamination record shall include the following information:</text>
      <paragraph num="(a)">
        <text>Unique case identifier;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Encoded sample identification;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Description of results; and</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Identifiers that led to an incident report.</text>
      </paragraph>
    </paragraph>
  </paragraph>
</regulation>