<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".03" citation="COMAR 10.51.05.03" title_num="10" subtitle_num="51" chapter_num="05" heading="Quality Assurance — Specific for Postmortem Forensic Toxicology.">
  <paragraph num="A.">
    <text>In addition to any applicable requirement in this chapter, a forensic laboratory performing postmortem forensic toxicology shall establish a:</text>
    <paragraph num="(1)">
      <text>Procedure for responding to requests for the laboratory’s information and documentation; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Policy for:</text>
      <paragraph num="(a)">
        <text>Retention and release of laboratory information;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Addressing the confidentiality of laboratory data; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Identifying:</text>
        <paragraph num="(i)">
          <text>The extent to which interpretations may be provided with test results; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Who is authorized to provide interpretations.</text>
        </paragraph>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Specimen Collection and Handling.</text>
    <paragraph num="(1)">
      <text>A laboratory director shall develop and provide, to all agencies or parties that submit or request postmortem toxicology analyses, instructions that include the specific requirements for the:</text>
      <paragraph num="(a)">
        <text>Type and minimum amount of specimen needed to perform the:</text>
        <paragraph num="(i)">
          <text>Requested analysis; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Subsequent interpretations;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>Type and size of specimen container;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Type and amount of preservative to be added to biological fluids, when applicable;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Labeling of each individual specimen container;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Packaging and transport of a specimen;</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Submission of relevant medical history on decedents who may carry a highly infectious disease, such as tuberculosis, hepatitis, or human immunodeficiency virus (HIV);</text>
      </paragraph>
      <paragraph num="(g)">
        <text>Labeling of each specimen as to type and source, if applicable; and</text>
      </paragraph>
      <paragraph num="(h)">
        <text>Proper sealing of containers to prevent:</text>
        <paragraph num="(i)">
          <text>Leakage of the specimen container; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Cross-contamination between specimens.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>A licensee shall ensure that a specimen submitted for postmortem toxicology testing includes documentation that provides pertinent case information, including the:</text>
      <paragraph num="(a)">
        <text>Name of decedent;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Date of specimen collection; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Pertinent history of the case.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>For a specimen received for postmortem toxicology testing, a laboratory shall maintain a written or electronic record documenting the:</text>
      <paragraph num="(a)">
        <text>Condition of the specimen;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Handwritten initials or electronic signature of the individual who received the specimen;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Date the specimen was received;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Name of the decedent;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Unique identifier assigned to the specimen;</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Specimen type;</text>
      </paragraph>
      <paragraph num="(g)">
        <text>Date the specimen was collected; and</text>
      </paragraph>
      <paragraph num="(h)">
        <text>Identification of the individual who collected the specimen.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>A licensee shall develop and follow a policy for the retention, release, and disposal of specimens submitted for postmortem toxicology testing.</text>
    </paragraph>
  </paragraph>
</regulation>