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<regulation prefix="Regulation" num=".07" citation="COMAR 10.51.06.07" title_num="10" subtitle_num="51" chapter_num="06" heading="Director — Specific Duties and Responsibilities.">
  <text>A forensic laboratory director shall:</text>
  <paragraph num="A.">
    <text>Be accessible to forensic laboratory employees to provide on-site, telephonic, or electronic consultation as needed;</text>
  </paragraph>
  <paragraph num="B.">
    <text>Ensure that:</text>
    <paragraph num="(1)">
      <text>Forensic testing and examination systems developed and used for each forensic analysis performed in the laboratory provide quality laboratory services for all aspects of test and examination performance including the pre-analytic, analytic, and post-analytic phases of the forensic analysis;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The physical plant and environmental conditions of the forensic laboratory are appropriate for the testing performed;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Forensic laboratory employees are provided a safe work environment and are protected from physical, chemical, and biological hazards;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>A forensic analysis method selected for use in the laboratory has the capability of providing an accurate and reliable result with known or defined uncertainty;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Verification procedures used are adequate to determine the accuracy, precision, uncertainty, and other pertinent performance characteristics of each forensic analysis method;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Forensic analysis employees perform the forensic analysis methods as required by the laboratory’s established procedures to assure accurate and reliable results;</text>
    </paragraph>
    <paragraph num="(7)">
      <text>The forensic laboratory participates in and uses a Department-approved proficiency testing provider as set forth in this subtitle, for each forensic analysis the laboratory performs or offers to perform;</text>
    </paragraph>
    <paragraph num="(8)">
      <text>Received proficiency test reports are reviewed by the appropriate forensic analysis employees to:</text>
      <paragraph num="(a)">
        <text>Evaluate the laboratory’s performance; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Identify any problems which require corrective action;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(9)">
      <text>A corrective action plan is followed when a proficiency test result is found to be unacceptable or unsatisfactory;</text>
    </paragraph>
    <paragraph num="(10)">
      <text>Quality control, quality assurance and assessment, and ethics and data integrity programs are established, maintained, and followed as set forth in this subtitle;</text>
    </paragraph>
    <paragraph num="(11)">
      <text>A case file is maintained for a minimum of 10 years after the case is received;</text>
    </paragraph>
    <paragraph num="(12)">
      <text>Acceptable levels of analytical performance for each forensic analysis are established and maintained;</text>
    </paragraph>
    <paragraph num="(13)">
      <text>Remedial actions are taken and documented if a deviation from the forensic laboratory’s established performance characteristics is identified;</text>
    </paragraph>
    <paragraph num="(14)">
      <text>Procedures and mechanisms are established, maintained, and followed to preserve evidentiary sample and specimen integrity and identity throughout the forensic analysis process;</text>
    </paragraph>
    <paragraph num="(15)">
      <text>Forensic test and examination results are reported only when the forensic analysis system is functioning properly;</text>
    </paragraph>
    <paragraph num="(16)">
      <text>Reports of forensic analysis results include pertinent information required for correct interpretation;</text>
    </paragraph>
    <paragraph num="(17)">
      <text>Consultation is available to the forensic laboratory’s clients on matters relating to the quality of the reported forensic analysis results and interpretation;</text>
    </paragraph>
    <paragraph num="(18)">
      <text>There is on-site supervision of forensic analyses and examinations being performed;</text>
    </paragraph>
    <paragraph num="(19)">
      <text>An employee has sufficient education and experience related to the forensic analyses and examinations being performed, has completed the training for the type and complexity of tests and examinations performed, and has demonstrated reliable test performance and examination operations to provide and report accurate results;</text>
    </paragraph>
    <paragraph num="(20)">
      <text>Before performing a forensic analysis on an evidentiary sample or specimen, an employee has demonstrated reliable and proficient analysis and the providing and reporting of accurate results;</text>
    </paragraph>
    <paragraph num="(21)">
      <text>Policies and procedures are established for monitoring the performance of employees who conduct pre-analytical, analytical, and post-analytical phases of the forensic analysis process to assure that:</text>
      <paragraph num="(a)">
        <text>Employees are competent and maintain competency to:</text>
        <paragraph num="(i)">
          <text>Process samples and specimens;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Perform forensic tests and examinations; and</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Report forensic analysis results promptly and proficiently; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>Employee needs for remedial training or continuing education to improve skills are identified, when necessary; and</text>
      </paragraph>
    </paragraph>
    <paragraph num="(22)">
      <text>A procedure manual is available to and followed by all employees responsible for any aspect of the forensic analysis process;</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Employ a sufficient number of forensic laboratory employees with the required education, experience, and training, and in accordance with the employee responsibilities set forth in this chapter to:</text>
    <paragraph num="(1)">
      <text>Provide consultation and court testimony;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Supervise the performance of forensic analyses;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Collect, process, and store evidentiary samples and specimens;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Perform forensic analysis procedures; and</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Report forensic analysis results promptly and proficiently;</text>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>Establish and specify, in writing, the duties and responsibilities of each:</text>
    <paragraph num="(1)">
      <text>Consultant;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Technical leader; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Individual engaged in the performance of the pre-analytic, analytic, and post-analytic phases of a forensic analysis;</text>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>Identify in the written duties and responsibilities required in §D of this regulation:</text>
    <paragraph num="(1)">
      <text>What forensic tests, examinations, and procedures each individual is authorized to perform;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The competencies required to perform each forensic test, examination, and procedure;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Whether supervision is required for specimen and sample processing, forensic analysis performance, or result reporting; and</text>
    </paragraph>
    <paragraph num="(4)">
      <text>If review by a technical leader or director is required before reporting a forensic analysis result; and</text>
    </paragraph>
  </paragraph>
  <paragraph num="F.">
    <text>Have the authority to initiate, suspend, and resume forensic analysis operations for:</text>
    <paragraph num="(1)">
      <text>The laboratory; or</text>
    </paragraph>
    <paragraph num="(2)">
      <text>An individual analyst or examiner.</text>
    </paragraph>
  </paragraph>
</regulation>