<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".03" citation="COMAR 10.06.01.03" title_num="10" subtitle_num="06" chapter_num="01" heading="Reportable Diseases, Conditions, Outbreaks, and Unusual Manifestations; Submitting Clinical Materials.">
  <paragraph num="A.">
    <text>A person, as set forth in Regulation .04 of this chapter, shall report the diseases or conditions listed in §C of this regulation, or any other condition as requested by the Secretary.</text>
  </paragraph>
  <paragraph num="B.">
    <text>Upon a positive laboratory finding for a disease or condition listed in §C of this regulation, or upon request of the Secretary, the director of a medical laboratory or a laboratory that possesses a biological agent as defined in COMAR 10.10.11.03B(8) shall:</text>
    <paragraph num="(1)">
      <text>Submit clinical material to the Department's public health laboratory; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Include information about the clinical material on a form provided by the Secretary.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>List of Reportable Diseases and Conditions.</text>
    <paragraph num="1.">
      <text>As required to report in Regulation .04A(1)—(3), (5), and (6) of this chapter.</text>
    </paragraph>
    <paragraph num="2.">
      <text>The time frame for reporting is specified in Regulation .04C of this chapter.</text>
    </paragraph>
    <paragraph num="3.">
      <text>Clinical material shall be submitted according to §B of this regulation.</text>
    </paragraph>
    <paragraph num="4.">
      <text>Any grouping or clustering of patients having similar disease, symptoms, or syndromes that may indicate the presence of a disease outbreak.</text>
    </paragraph>
    <paragraph num="5.">
      <text>Suspected hepatitis C as indicated by:</text>
      <paragraph num="(a)">
        <text>Any hepatitis C antibody results that are positive;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Any hepatitis C virus RNA results associated with the results in(a) of this footnote that are qualitative or quantitative, if the results are:</text>
        <paragraph num="(i)">
          <text>Positive; or</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Negative; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(c)">
        <text>Any hepatitis C virus RNA results associated with the results in(a) of this footnote if the hepatitis C virus is:</text>
        <paragraph num="(i)">
          <text>Detected; or</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Undetected.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="6.">
      <text>Acquired immunodeficiency syndrome (AIDS) and human immunodeficiency virus (HIV), including CD4+ lymphocyte count and viral load, are reportable under COMAR 10.18.</text>
    </paragraph>
    <paragraph num="7.">
      <text>Suspected syphilis as indicated by:</text>
      <paragraph num="(a)">
        <text>Any treponemal or non-treponemal results that are qualitative or quantitative, if the results are:</text>
        <paragraph num="(i)">
          <text>Positive;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Reactive; or</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Inconclusive; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>Any negative or non-reactive results associated with the positive, reactive, or inconclusive results in(a) of this footnote.</text>
      </paragraph>
    </paragraph>
    <paragraph num="8.">
      <text>Tuberculosis confirmed by culture and suspected tuberculosis as indicated by:</text>
      <paragraph num="(a)">
        <text>A laboratory confirmed acid-fast bacillus on smear;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>An abnormal chest radiograph suggestive of active tuberculosis;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>A laboratory confirmed biopsy report consistent with active tuberculosis; or</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Initiation of two or more anti-tuberculosis medications.</text>
      </paragraph>
    </paragraph>
    <paragraph num="9.">
      <text>Latent tuberculosis infection as indicated when:</text>
      <paragraph num="(a)">
        <text>There is a positive result on an Interferon Gamma Release Assay, Tuberculin Skin Test, or any other test indicating tuberculosis infection; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Active or suspected tuberculosis has been ruled out.</text>
      </paragraph>
    </paragraph>
    <paragraph num="10.">
      <text>Vibriosis, non-cholera, identified in any specimen taken from teeth, gingival tissues, or oral mucosa is not reportable.</text>
    </paragraph>
  </paragraph>
</regulation>