<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".01" citation="COMAR 10.18.02.01" title_num="10" subtitle_num="18" chapter_num="02" heading="Scope.">
  <paragraph num="A.">
    <text>This chapter establishes the requirements for:</text>
    <paragraph num="(1)">
      <text>Physician reporting of a:</text>
      <paragraph num="(a)">
        <text>Case of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS); and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Birth of an infant whose mother has tested positive for HIV;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Institution reporting of a case of HIV or AIDS;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Laboratory reporting of a test result for:</text>
      <paragraph num="(a)">
        <text>HIV detection;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>HIV viral load;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>CD4+ cell count or percentage; or</text>
      </paragraph>
      <paragraph num="(d)">
        <text>HIV genotype sequence; and</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>Follow-up of:</text>
      <paragraph num="(a)">
        <text>A physician's report of HIV or AIDS;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>A physician's report of an infant whose mother has tested positive for HIV;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>An institution's report of HIV or AIDS; and</text>
      </paragraph>
      <paragraph num="(d)">
        <text>A laboratory’s report of a test result for:</text>
        <paragraph num="(i)">
          <text>HIV detection;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>HIV viral load;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>CD4+ cell count or percentage; or</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>HIV genotype sequence infection or CD4+ count.</text>
        </paragraph>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Except as noted in §C of this regulation, this chapter applies to all instances of laboratory testing of specimens from a human body for:</text>
    <paragraph num="(1)">
      <text>HIV detection;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>HIV viral load;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>CD4+ cell count or percentage; or</text>
    </paragraph>
    <paragraph num="(4)">
      <text>HIV genotype sequence.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>This chapter does not apply if the specimen from a human body is:</text>
    <paragraph num="(1)">
      <text>Not tested for:</text>
      <paragraph num="(a)">
        <text>HIV detection;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>HIV viral load;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>CD4+ cell count or percentage; or</text>
      </paragraph>
      <paragraph num="(d)">
        <text>HIV genotype sequence;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Tested for HIV detection solely for the purpose of determining the suitability of the source individual as a prospective donor of blood, semen, or tissue;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Taken from a patient at a designated anonymous HIV test site solely for the purpose of performing an anonymous HIV test;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Tested for HIV detection as part of research conducted by an institution within Maryland under the following conditions:</text>
      <paragraph num="(a)">
        <text>All personal identifiers are removed from the specimen before testing;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The specimen cannot be linked to the individual from whom the specimen was taken;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>The result cannot be linked to the individual from whom the specimen was taken; and</text>
      </paragraph>
      <paragraph num="(d)">
        <text>The research protocol has been approved by an institutional review board;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(5)">
      <text>Tested for HIV detection as part of research conducted under a research protocol approved by an institutional review board of an institution located outside of Maryland;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Taken from a patient known to reside outside of the United States; or</text>
    </paragraph>
    <paragraph num="(7)">
      <text>Tested for HIV detection as part of a research project that has been approved under Regulation .02 of this chapter for an exemption.</text>
    </paragraph>
  </paragraph>
</regulation>