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<regulation prefix="Regulation" num=".01" citation="COMAR 10.51.05.01" title_num="10" subtitle_num="51" chapter_num="05" heading="Quality Assurance — General.">
  <text>To obtain or maintain a permit to operate a forensic laboratory, a person or licensee shall ensure that the forensic laboratory:</text>
  <paragraph num="A.">
    <text>Establishes and follows policies and procedures for a comprehensive quality assurance program designed to monitor and evaluate the ongoing and overall quality and safety of the total examination and forensic analysis process;</text>
  </paragraph>
  <paragraph num="B.">
    <text>Maintains a quality assurance program that:</text>
    <paragraph num="(1)">
      <text>Continually evaluates the effectiveness of the laboratory’s policies and procedures;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Routinely revises policies and procedures based on the results of ongoing evaluation;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Identifies and corrects problems;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Assures:</text>
      <paragraph num="(a)">
        <text>Accurate, complete, and reliable reporting of results of examinations and analyses;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Technical procedures are validated and are accepted practice in the forensic discipline; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Adequate and competent employees;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(5)">
      <text>Requires documentation of all quality assurance and quality control activities; and</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Includes policies and procedures for:</text>
      <paragraph num="(a)">
        <text>Handling and preservation of evidence;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Calibration and maintenance of equipment;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Handling, maintaining, and securing laboratory records including case records and reports;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Evaluation and approval of employees;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Laboratory security;</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Identifying and implementing corrective actions;</text>
      </paragraph>
      <paragraph num="(g)">
        <text>Documenting and investigating complaints;</text>
      </paragraph>
      <paragraph num="(h)">
        <text>The operation of individual characteristic databases, where appropriate; and</text>
      </paragraph>
      <paragraph num="(i)">
        <text>Data integrity and ethics;</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Develops and maintains:</text>
    <paragraph num="(1)">
      <text>An organizational chart of all employees;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Job requirements and a job description for each contractor; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Employee records that include, but are not limited to:</text>
      <paragraph num="(a)">
        <text>Job requirements and a job description for each employee;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Educational background and qualifications;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Curriculum vitae;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Court testimony evaluations and a record that the evaluations are reviewed with each examiner and analyst;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Documentation of successful completion of a training program set forth by the laboratory, including competency testing;</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Authorization to perform independent casework; and</text>
      </paragraph>
      <paragraph num="(g)">
        <text>Performance evaluations;</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>Establishes and maintains a forensic laboratory safety program;</text>
  </paragraph>
  <paragraph num="E.">
    <text>Employs appropriately trained employees and possesses equipment to conduct the scope of forensic services offered;</text>
  </paragraph>
  <paragraph num="F.">
    <text>Maintains reference literature in physical or electronic form that covers all disciplines and subdisciplines for which services are offered;</text>
  </paragraph>
  <paragraph num="G.">
    <text>Designates an individual as the quality assurance manager;</text>
  </paragraph>
  <paragraph num="H.">
    <text>Defines and maintains a document retention policy;</text>
  </paragraph>
  <paragraph num="I.">
    <text>Maintains a facility that is designed to ensure the integrity of the forensic analyses and the evidence;</text>
  </paragraph>
  <paragraph num="J.">
    <text>Conducts:</text>
    <paragraph num="(1)">
      <text>Administrative review of all cases and reports before issuing a report; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Technical review, of no less than 5 percent of cases as determined by the laboratory director or designee, to ensure conclusions and supporting data are within the constraints of scientific knowledge; and</text>
    </paragraph>
  </paragraph>
  <paragraph num="K.">
    <text>Establishes a mechanism to address unresolved discrepant conclusions between an analyst and the technical reviewer.</text>
  </paragraph>
</regulation>