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<subtitle article="ghg" title_number="17" subtitle_number="2A" title_name="Laboratories" subtitle_name="Forensic Laboratories">
  <section article="ghg" article_name="Health - General" number="17-2A-01" title_number="17" title_name="Laboratories" subtitle_number="2A" subtitle_name="Forensic Laboratories">
    <level label="a">
      <text>In this subtitle the following words have the meanings indicated.</text>
    </level>
    <level label="b">
      <level label="1">
        <text>“Forensic analysis” means a medical, chemical,  toxicologic, firearms, or other expert examination or test  performed on physical evidence, including DNA evidence, for the  purpose of determining the connection of the evidence to a  criminal act.</text>
      </level>
      <level label="2">
        <text>“Forensic analysis” includes an examination or test  required by a law enforcement agency, prosecutor, criminal  suspect or defendant, or court.</text>
      </level>
      <level label="3">
        <text>“Forensic analysis” does not include:</text>
        <level label="i">
          <text>A test of a specimen of breath or blood to  determine alcohol concentration or controlled dangerous  substance content;</text>
        </level>
        <level label="ii">
          <text>Forensic information technology;</text>
        </level>
        <level label="iii">
          <text>A presumptive test performed at a crime scene;</text>
        </level>
        <level label="iv">
          <text>A presumptive test performed for the purpose  of determining compliance with a term or condition of community  supervision or parole and conducted by or under contract with a  county department of corrections or the State Department of  Public Safety and Correctional Services; or</text>
        </level>
        <level label="v">
          <text>An expert examination or test conducted  principally for the purpose of scientific research, medical  practice, civil or administrative litigation, or any other purpose  unrelated to determining the connection of physical evidence to a  criminal act.</text>
        </level>
      </level>
    </level>
    <level label="c">
      <text>“Forensic information technology” means digital or  electronic evidence that is stored or transmitted electronically.</text>
    </level>
    <level label="d">
      <level label="1">
        <text>“Forensic laboratory” means a facility, entity, or site that offers or performs forensic analysis.</text>
      </level>
      <level label="2">
        <text>“Forensic laboratory” includes a laboratory owned or operated by the State, a county or municipal corporation in the State, or another governmental entity.</text>
      </level>
      <level label="3">
        <text>“Forensic laboratory” does not include:</text>
        <level label="i">
          <text>A forensic laboratory operated by the federal  government; or</text>
        </level>
        <level label="ii">
          <text>A laboratory licensed or certified by the  Department of Agriculture.</text>
        </level>
      </level>
    </level>
    <level label="e">
      <text>“License” means a permit, letter of exception, certificate, or other document issued by the Secretary granting approval or authority to offer or perform forensic laboratory tests, examinations, or analyses in the State.</text>
    </level>
    <level label="f">
      <text>“Limited forensic analysis” means a forensic laboratory  test or analysis defined in regulations adopted by the Secretary.</text>
    </level>
    <level label="g">
      <text>“Physical evidence” means any object, thing, or substance  relating to a criminal act.</text>
    </level>
  </section>
  <section article="ghg" article_name="Health - General" number="17-2A-02" title_number="17" title_name="Laboratories" subtitle_number="2A" subtitle_name="Forensic Laboratories">
    <level label="a">
      <level label="1">
        <text>The Secretary shall adopt regulations that set standards and requirements for forensic laboratories.</text>
      </level>
      <level label="2">
        <text>The regulations shall contain the standards and requirements that the Secretary considers necessary to assure the citizens of the State that forensic laboratories provide safe, reliable, and accurate services.</text>
      </level>
      <level label="3">
        <text>The regulations shall:</text>
        <level label="i">
          <text>Require the director of a forensic laboratory to establish and administer an ongoing quality assurance program using standards acceptable to the Secretary;</text>
        </level>
        <level label="ii">
          <text>Require the director of a forensic laboratory to retain all case files for at least 10 years;</text>
        </level>
        <level label="iii">
          <text>Establish qualifications for the personnel of forensic laboratories;</text>
        </level>
        <level label="iv">
          <text>Establish procedures for verifying the background and education of the personnel of forensic laboratories; and</text>
        </level>
        <level label="v">
          <text>Establish any additional standards that the Secretary considers necessary to assure that forensic laboratories provide accurate and reliable services.</text>
        </level>
      </level>
    </level>
    <level label="b">
      <level label="1">
        <text>A forensic laboratory that examines or analyzes physical evidence shall demonstrate satisfactory performance in an approved proficiency testing program specifically related to the particular forensic analysis being  performed.</text>
      </level>
      <level label="2">
        <text>The Secretary shall adopt regulations for the forensic proficiency testing program that:</text>
        <level label="i">
          <text>Define satisfactory proficiency testing performance; and</text>
        </level>
        <level label="ii">
          <text>Set standards and requirements that a forensic proficiency testing program shall meet.</text>
        </level>
      </level>
      <level label="3">
        <text>The Department shall review a forensic laboratory’s proficiency testing program.</text>
      </level>
    </level>
    <level label="c">
      <text>To assure compliance with the standards and requirements under this subtitle, the Secretary shall conduct:</text>
      <level label="1">
        <text>An inspection of each forensic laboratory for which a license to operate is sought; and</text>
      </level>
      <level label="2">
        <text>An inspection of each forensic laboratory for which a license has been issued.</text>
      </level>
    </level>
    <level label="d">
      <text>To assure compliance with the standards and requirements under this subtitle, the Secretary may conduct:</text>
      <level label="1">
        <text>A complaint investigation; and</text>
      </level>
      <level label="2">
        <text>A validation survey of an accredited forensic laboratory.</text>
      </level>
    </level>
  </section>
  <section article="ghg" article_name="Health - General" number="17-2A-03" title_number="17" title_name="Laboratories" subtitle_number="2A" subtitle_name="Forensic Laboratories">
    <level label="a">
      <text>Forensic laboratory deficiency statements and plans of  correction are public documents.</text>
    </level>
    <level label="b">
      <text>A forensic laboratory shall make discrepancy logs,  contamination records, and test results  available to the public within 30 days of a written request.</text>
    </level>
    <level label="c">
      <text>Except as provided in subsection (a) of this section, the  proceedings, records, and files of an organization or State agency  responsible for assuring compliance with this subtitle shall be  confidential and not discoverable or admissible in evidence in a  civil or criminal action.</text>
    </level>
  </section>
  <section article="ghg" article_name="Health - General" number="17-2A-04" title_number="17" title_name="Laboratories" subtitle_number="2A" subtitle_name="Forensic Laboratories">
    <level label="a">
      <text>After December 31, 2011, a forensic laboratory shall hold a license  issued by the Secretary before the forensic laboratory may offer or perform  forensic analysis in the State.</text>
    </level>
    <level label="b">
      <text>The Secretary shall issue a letter of exception to a  laboratory that:</text>
      <level label="1">
        <text>Performs only limited forensic analysis; and</text>
      </level>
      <level label="2">
        <text>Meets the exception requirements in regulations  adopted by the Secretary.</text>
      </level>
    </level>
    <level label="c">
      <text>The Secretary may grant an out–of–state forensic  laboratory a waiver from the licensure requirements of this  subtitle with conditions.</text>
    </level>
  </section>
  <section article="ghg" article_name="Health - General" number="17-2A-05" title_number="17" title_name="Laboratories" subtitle_number="2A" subtitle_name="Forensic Laboratories">
    <text>To qualify for a license, an applicant shall provide evidence to satisfy the Secretary that the forensic laboratory and its personnel meet the standards and requirements of this subtitle.</text>
  </section>
  <section article="ghg" article_name="Health - General" number="17-2A-06" title_number="17" title_name="Laboratories" subtitle_number="2A" subtitle_name="Forensic Laboratories">
    <level label="a">
      <text>An applicant for a license shall submit an application to the Secretary on the form that the Secretary requires.</text>
    </level>
    <level label="b">
      <text>An application for a license to operate a forensic laboratory shall include:</text>
      <level label="1">
        <text>The name of the operator or owner;</text>
      </level>
      <level label="2">
        <text>The tests or examinations that the forensic laboratory would provide; and</text>
      </level>
      <level label="3">
        <text>Any other information that the Secretary requires.</text>
      </level>
    </level>
  </section>
  <section article="ghg" article_name="Health - General" number="17-2A-07" title_number="17" title_name="Laboratories" subtitle_number="2A" subtitle_name="Forensic Laboratories">
    <level label="a">
      <text>The Secretary shall issue a license to an applicant that meets the standards and requirements of this subtitle.</text>
    </level>
    <level label="b">
      <text>A forensic laboratory license shall include the name of the:</text>
      <level label="1">
        <text>Forensic laboratory;</text>
      </level>
      <level label="2">
        <text>Laboratory director; and</text>
      </level>
      <level label="3">
        <text>Operator or owner of the laboratory.</text>
      </level>
    </level>
    <level label="c">
      <text>A forensic laboratory license shall designate the tests, examinations, or analyses that may be offered or performed by the laboratory.</text>
    </level>
    <level label="d">
      <text>A forensic laboratory may not operate in a manner not designated by the license issued under this subtitle.</text>
    </level>
    <level label="e">
      <text>A forensic laboratory license issued by the Secretary under this subtitle is not transferable.</text>
    </level>
  </section>
  <section article="ghg" article_name="Health - General" number="17-2A-09" title_number="17" title_name="Laboratories" subtitle_number="2A" subtitle_name="Forensic Laboratories">
    <level label="a">
      <text>The Secretary may deny a license to an applicant or suspend, revoke, or limit a license or the authority of a licensee to offer or perform tests that a license sets forth, if the forensic laboratory or its director or other personnel fail to meet the standards and requirements of this subtitle.</text>
    </level>
    <level label="b">
      <level label="1">
        <text>If the Secretary finds that a forensic laboratory  licensed under this subtitle no longer meets the standards and  requirements of this subtitle, the Secretary may:</text>
        <level label="i">
          <text>Revoke the license of the forensic laboratory;  or</text>
        </level>
        <level label="ii">
          <text>Suspend the license of the forensic  laboratory.</text>
        </level>
      </level>
      <level label="2">
        <text>If a deficiency exists, the Secretary may:</text>
        <level label="i">
          <text>Impose a directed plan of correction;</text>
        </level>
        <level label="ii">
          <text>Regularly inspect the forensic laboratory to  assure compliance with the directed plan of correction; or</text>
        </level>
        <level label="iii">
          <text>Limit the testing authorized by the license.</text>
        </level>
      </level>
    </level>
    <level label="c">
      <text>If the Secretary finds that a forensic laboratory  provided erroneous or questionable test results, the Secretary  may order the laboratory to provide written notification to:</text>
      <level label="1">
        <text>The person or agency that ordered the tests;</text>
      </level>
      <level label="2">
        <text>The Office of the Public Defender or counsel of  record; and</text>
      </level>
      <level label="3">
        <text>The State’s Attorney.</text>
      </level>
    </level>
    <level label="d">
      <text>A State’s Attorney who receives notification from a  laboratory under subsection (c) of this section shall notify the  victim of the criminal act or the victim’s representative of the  erroneous or questionable test results.</text>
    </level>
    <level label="e">
      <text>A forensic laboratory that fails to comply with an order issued by the Secretary under subsection (c) of this section is subject to a civil penalty of up to $1,000 for each day of noncompliance after the deadline for compliance stated in the  Secretary’s order, not to exceed a maximum penalty of $50,000.</text>
    </level>
    <level label="f">
      <text>Except as otherwise provided in the Administrative Procedure Act, before the Secretary denies, suspends, or revokes a license, or imposes a civil penalty under this section, the Secretary shall give the applicant or licensee notice and an opportunity for a hearing.</text>
    </level>
  </section>
  <section article="ghg" article_name="Health - General" number="17-2A-10" title_number="17" title_name="Laboratories" subtitle_number="2A" subtitle_name="Forensic Laboratories">
    <level label="a">
      <text>In this section, “discriminate or retaliate” includes:</text>
      <level label="1">
        <text>Failing to promote an individual or to provide another employment–related benefit for which the individual would otherwise be eligible;</text>
      </level>
      <level label="2">
        <text>Making an adverse evaluation or decision in relation to accreditation, certification, credentialing, or licensing of the individual; or</text>
      </level>
      <level label="3">
        <text>Taking a personnel action that is adverse to the individual concerned.</text>
      </level>
    </level>
    <level label="b">
      <text>An employee who works in a forensic laboratory may disclose information to the Secretary that the employee believes evidences a violation of standards and requirements for forensic laboratories in the State.</text>
    </level>
    <level label="c">
      <text>A forensic laboratory may not discriminate or retaliate against an employee because the employee:</text>
      <level label="1">
        <text>Discloses information under subsection (b) of this section; or</text>
      </level>
      <level label="2">
        <text>Has agreed to cooperate with an investigation of the forensic laboratory.</text>
      </level>
    </level>
    <level label="d">
      <level label="1">
        <text>The Secretary shall develop, through regulation, a document that informs the employees of a forensic laboratory of the procedures to report instances of noncompliance or other violations of the standards and requirements for forensic  laboratories in the State.</text>
      </level>
      <level label="2">
        <text>The Secretary shall distribute the document developed under paragraph (1) of this subsection to forensic laboratories in the State.</text>
      </level>
    </level>
    <level label="e">
      <text>A forensic laboratory shall post the document developed under subsection (d) of this section in a conspicuous place.</text>
    </level>
    <level label="f">
      <text>An employee of a forensic laboratory who has been discriminated or retaliated against in violation of subsection (c) of this section may initiate an action and, on prevailing, shall be entitled to:</text>
      <level label="1">
        <text>Reinstatement;</text>
      </level>
      <level label="2">
        <text>Reimbursement for lost wages;</text>
      </level>
      <level label="3">
        <text>Work benefits lost as a result of the unlawful acts of the employing laboratory; and</text>
      </level>
      <level label="4">
        <text>Reasonable attorney’s fees and costs associated with pursuing the action.</text>
      </level>
    </level>
    <level label="g">
      <text>No action may be brought under this  subsection more than 2 years after the discrimination or retaliation that is the basis for the action.</text>
    </level>
  </section>
  <section article="ghg" article_name="Health - General" number="17-2A-11" title_number="17" title_name="Laboratories" subtitle_number="2A" subtitle_name="Forensic Laboratories">
    <level label="a">
      <text>A person that violates any provision of this subtitle is guilty of a misdemeanor and on conviction is subject to:</text>
      <level label="1">
        <text>A fine not exceeding $100 for the first offense; and</text>
      </level>
      <level label="2">
        <text>A fine not exceeding $500 for each subsequent conviction for a violation of the same provision.</text>
      </level>
    </level>
    <level label="b">
      <text>Each day on which a violation occurs is a separate violation under this section.</text>
    </level>
  </section>
  <section article="ghg" article_name="Health - General" number="17-2A-12" title_number="17" title_name="Laboratories" subtitle_number="2A" subtitle_name="Forensic Laboratories">
    <level label="a">
      <text>The Governor shall establish a Forensic Laboratory Advisory Committee to advise the Secretary on matters relating to the implementation of the provisions of this subtitle.</text>
    </level>
    <level label="b">
      <text>The Advisory Committee shall consist of the following 10 members:</text>
      <level label="1">
        <text>The Director of the Laboratories Administration in the Department, or the Director’s designee;</text>
      </level>
      <level label="2">
        <text>The Director of the Office of Health Care Quality in the Department, or the Director’s designee; and</text>
      </level>
      <level label="3">
        <text>The following members, appointed by the Governor:</text>
        <level label="i">
          <text>One from the American Society for Clinical Laboratory Science;</text>
        </level>
        <level label="ii">
          <text>One from the University of Maryland School of Medicine, Department of Medical Research and Technology;</text>
        </level>
        <level label="iii">
          <text>One from the American Association for Laboratory Accreditation;</text>
        </level>
        <level label="iv">
          <text>One from the American Academy of Forensic Sciences;</text>
        </level>
        <level label="v">
          <text>One from the ANSI–ASQ National Accreditation Board; and</text>
        </level>
        <level label="vi">
          <text>Three directors of forensic laboratories in the State, including:</text>
          <level label="1">
            <text>One from a forensic laboratory operated by the State;</text>
          </level>
          <level label="2">
            <text>One from a forensic laboratory operated by a county; and</text>
          </level>
          <level label="3">
            <text>One from a forensic laboratory operated by a municipal corporation.</text>
          </level>
        </level>
      </level>
    </level>
    <level label="c">
      <level label="1">
        <text>The term of an appointed member is 3 years.</text>
      </level>
      <level label="2">
        <text>The terms of appointed members are staggered as required by the terms provided for appointed members of the Advisory Committee on October 1, 2007.</text>
      </level>
    </level>
    <level label="d">
      <text>The Governor shall designate the chair of the Advisory Committee.</text>
    </level>
    <level label="e">
      <text>A majority of the members serving on the Advisory Committee represents a quorum to conduct business.</text>
    </level>
    <level label="f">
      <text>A member of the Advisory Committee may not receive compensation but is entitled to reimbursement for expenses under the Standard State Travel Regulations, as provided in the State budget.</text>
    </level>
    <level label="g">
      <text>The Department shall provide staff for the Advisory Committee.</text>
    </level>
  </section>
</subtitle>