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<regulation prefix="Regulation" num=".05" citation="COMAR 10.51.05.05" title_num="10" subtitle_num="51" chapter_num="05" heading="Standard Operating Procedures Manual (SOPM).">
  <paragraph num="A.">
    <text>Policies and Procedures. A licensee shall ensure that all policies and procedures affecting the scope of activities performed in the laboratory are:</text>
    <paragraph num="(1)">
      <text>Documented; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Communicated to, understood by, available to, and implemented by employees performing the activities.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>A licensee shall ensure that:</text>
    <paragraph num="(1)">
      <text>Documents issued to employees are reviewed and approved for use by authorized employees before issue;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The current revision status and distribution of documents is established to preclude use of archived documents;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Authorized documents are available at all locations where casework is performed;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Archived documents are promptly removed from access or otherwise identified to ensure against unintended use;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Documents are uniquely identified, including date of issue or version, page numbering, total number of pages or a mark to signify the end of the document, and the issuing authority;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Changes to documents are approved by the same authority that issued the document and altered or new text is clearly identified; and</text>
    </paragraph>
    <paragraph num="(7)">
      <text>Documents in computerized systems have equivalent procedures.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>A licensee shall develop, establish, maintain, implement, and require that technical procedures meet the following:</text>
    <paragraph num="(1)">
      <text>The procedures included are:</text>
      <paragraph num="(a)">
        <text>Generally accepted in the appropriate forensic field or supported by data gathered and recorded in a scientific manner;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Available to all appropriate employees;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Able to produce valid and accurate results; and</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Reviewed annually by the director or the director’s designee and this review shall be documented;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>All procedures include, at a minimum:</text>
      <paragraph num="(a)">
        <text>Sample or specimen preparation, as needed for the method;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Required quality control, standard, and reference material;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Calibration requirements and instructions;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Interfering substances and potential sources of error;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Literature references;</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Special analytical and safety precautions;</text>
      </paragraph>
      <paragraph num="(g)">
        <text>Step-by-step instructions; and</text>
      </paragraph>
      <paragraph num="(h)">
        <text>Calculations, if required;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>The laboratory has a document control procedure to determine when the technical procedure has been discontinued or retired.</text>
    </paragraph>
    <paragraph num="(4)">
      <text>A laboratory procedure identifies which documents are to be maintained in the case file;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>All changes to a procedure are approved and signed by the director;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>The SOPM is available to all forensic analysts and examiners;</text>
    </paragraph>
    <paragraph num="(7)">
      <text>A departure from the SOPM is:</text>
      <paragraph num="(a)">
        <text>Approved by the laboratory director or qualified designee before implementation;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Scientifically validated before implementation;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Written; and</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Communicated to the quality assurance manager;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(8)">
      <text>The laboratory has a procedure for determining the reasons, criteria, or conditions for when a report is not produced;</text>
    </paragraph>
    <paragraph num="(9)">
      <text>The laboratory has a procedure or policy for technical review of reports that:</text>
      <paragraph num="(a)">
        <text>Defines criteria for the technical review, for example, number or percent of case reports reviewed or corrective action protocol if discrepancies are found;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Ensures that a review cannot be performed by the examiner or analyst who prepared the report; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Ensures that a technical review of a one-individual unit is performed at a review percentage determined by the laboratory director by an analyst or examiner of another licensed forensic laboratory, who is qualified within the same disciplines or subdisciplines; and</text>
      </paragraph>
    </paragraph>
    <paragraph num="(10)">
      <text>The laboratory has a procedure for administrative review that:</text>
      <paragraph num="(a)">
        <text>Requires that reviews be performed on all case reports;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Specifies who may perform the administrative review;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Clearly defines how the administrative review is documented; and</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Requires that reviews be performed before case reports are issued.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>A licensee shall ensure that the laboratory has a policy and procedure for the handling of written or oral complaints received from customers, laboratory employees, or other parties.</text>
  </paragraph>
  <paragraph num="E.">
    <text>Postmortem Forensic Toxicology. In addition to applicable sections of this regulation, a laboratory performing postmortem forensic toxicology shall have:</text>
    <paragraph num="(1)">
      <text>A record of sample signatures and initials of all employees handling specimens and performing analytical work; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>A procedure:</text>
      <paragraph num="(a)">
        <text>For periodically monitoring the purity of chemicals used as reference standards; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>That defines which postmortem forensic toxicology tests are to be performed on each type of case.</text>
      </paragraph>
    </paragraph>
  </paragraph>
</regulation>