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<regulation prefix="Regulation" num=".13" citation="COMAR 26.08.05.13" title_num="26" subtitle_num="08" chapter_num="05" heading="Laboratory Certification Denial, Provisional Certification, and Revocation of Certification.">
  <paragraph num="A.">
    <text>Denial of Initial Certification.</text>
    <paragraph num="(1)">
      <text>The Department may deny initial certification to a water quality laboratory for any of the following reasons:</text>
      <paragraph num="(a)">
        <text>Failure to comply with the minimum standards and qualifications required by this chapter;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Failure to participate in or analyze proficiency test samples;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Submittal of another water quality laboratory’s results for proficiency tests;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Intentionally false statements made on the application forms or any document associated with the certification application;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Conviction of any violation of the laws of Maryland related to water quality;</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Fraudulently or deceptively obtaining or attempting to obtain a certification;</text>
      </paragraph>
      <paragraph num="(g)">
        <text>Failure to pay the prescribed certification fees; or</text>
      </paragraph>
      <paragraph num="(h)">
        <text>Failure to submit or complete acceptable corrective actions to an on-site evaluation.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>The denial of initial certification because a water quality laboratory does not satisfactorily meet certification criteria is not appealable.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Provisional Certification.</text>
    <paragraph num="(1)">
      <text>The Department may downgrade a certification of a water quality laboratory for any of the following reasons:</text>
      <paragraph num="(a)">
        <text>Violation of any provision of this chapter;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Failure to report compliance data in accordance with COMAR 26.04.01 to the public water system or the Department in a timely manner, thereby preventing compliance with federal or State regulations or endangering public health;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Failure to participate in or analyze proficiency test samples in a timely manner;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Failure to report a change in ownership, management, location of facilities, or name of a water quality laboratory within a period of 30 days after the change has occurred; or</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Failure to submit or complete acceptable corrective actions to an on-site evaluation.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Procedure for Downgrading Laboratory Status to Provisional.</text>
      <paragraph num="(a)">
        <text>If a laboratory is subject to downgrading on the basis of criteria in §B of this regulation, the Certification Authority shall notify the laboratory director or owner by certified mail of its intent to downgrade within 30 days from becoming aware of the situation warranting downgrading.</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The laboratory director shall send a written response to the Certification Authority within 30 days of receipt of the letter specifying what immediate corrective actions are being taken and any proposed corrective actions that need the concurrence of the Certification Authority.</text>
      </paragraph>
      <paragraph num="(c)">
        <text>The Certification Authority shall notify the laboratory in writing, by certified mail, within 14 days of receipt of the laboratory’s response whether the corrective action taken is adequate or if the laboratory is being downgraded to provisionally certified status.</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Provisionally certified status may not exceed 90 days.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>Testing Under Provisional Certification.</text>
      <paragraph num="(a)">
        <text>If the Certification Authority determines that the laboratory results are reliable, a provisionally certified laboratory may analyze drinking water samples for compliance purposes.</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The laboratory shall notify its clients of its downgraded status in writing on any report.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Revocation of Certification for the Water Quality Laboratory.</text>
    <paragraph num="(1)">
      <text>The Department may revoke certification to a water quality laboratory for one or more of the following reasons:</text>
      <paragraph num="(a)">
        <text>Failure to comply with the minimum standards and qualifications required by this chapter;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Failure to participate in or analyze proficiency test samples, or to obtain acceptable laboratory results of tests required on the samples annually;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Operation in such a manner as to endanger the public health or safety;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Intentionally false statements made on the application forms or any document associated with certification;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Fraudulence, deliberate falsification, or misrepresentation of federal and State laws when reporting test results;</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Conviction of any violation of the laws of Maryland related to water quality laboratories or public drinking water systems;</text>
      </paragraph>
      <paragraph num="(g)">
        <text>Documentation of repeated episodes of unethical conduct of water quality laboratory operation;</text>
      </paragraph>
      <paragraph num="(h)">
        <text>Failure to pay the prescribed fees associated with certification or renewal of certification;</text>
      </paragraph>
      <paragraph num="(i)">
        <text>Fraudulent or deceptive use of a certification;</text>
      </paragraph>
      <paragraph num="(j)">
        <text>Fraudulently or deceptively obtaining or attempting to obtain a certification;</text>
      </paragraph>
      <paragraph num="(k)">
        <text>Submittal of another water quality laboratory’s results for proficiency tests; or</text>
      </paragraph>
      <paragraph num="(l)">
        <text>Failure to implement corrective actions to an on-site evaluation.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Procedure for Revocation.</text>
      <paragraph num="(a)">
        <text>The Certification Authority shall notify the laboratory, by certified mail, of the intent to revoke certification. The notification shall state the reasons that the laboratory’s certification is being revoked and set forth corrective actions when applicable.</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The laboratory shall have 30 days from receipt of the notice of intent to revoke to submit documentation that shows the decision does not meet the criteria in this section. The documentation and a letter of explanation shall be sent by certified mail to the attention of the certification officer.</text>
      </paragraph>
      <paragraph num="(c)">
        <text>If the laboratory has not responded within 30 days of the notification of the intent to revoke the certification, the Certification Authority may issue a notice of revocation. A copy of the Department’s judicial review process shall be included with each notice of revocation.</text>
      </paragraph>
      <paragraph num="(d)">
        <text>If the laboratory provides documentation and an explanation within the required time, the Certification Authority shall review the submission and determine whether to proceed with revocation.</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Within 30 days of receipt of the laboratory’s submission, the Certification Authority shall notify the laboratory either that the documentation is satisfactory to address the reasons for revocation or that certification is revoked.</text>
      </paragraph>
      <paragraph num="(f)">
        <text>If the Certification Authority determines after review of the laboratory’s submission to revoke the certification, the revocation date may not be sooner than 30 days from the Certification Authority’s notification to the laboratory. A copy of the Department’s judicial review process shall be included with each notice of revocation.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>Upon revocation:</text>
      <paragraph num="(a)">
        <text>A water quality laboratory shall return its certificate and parameter list; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>A water quality laboratory may not analyze drinking water samples for compliance.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>Request for Reinstatement of Certification.</text>
    <paragraph num="(1)">
      <text>Revoked Certification. Through a written request, a laboratory may seek reinstatement of certification if a laboratory can demonstrate to the Certification Authority’s satisfaction that the deficiencies which resulted in revocation have been corrected. The Certification Authority may require an on-site evaluation, successful analysis of unknown samples, or other measures before determining that a laboratory’s certification should be reinstated.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Expired Certification. If a water quality laboratory demonstrates that it meets all renewal requirements, the Department may reinstate the certification of the water quality laboratory.</text>
    </paragraph>
  </paragraph>
</regulation>