<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".08" citation="COMAR 10.18.08.08" title_num="10" subtitle_num="18" chapter_num="08" heading="Consent and Pretest Requirements for HIV Testing in Nonclinical Settings.">
  <paragraph num="A.">
    <text>For HIV tests administered in nonclinical settings, as permitted in Regulations .03 and .04 of this chapter, the individual administering the HIV test shall:</text>
    <paragraph num="(1)">
      <text>Utilize the HIV informed consent form approved by the Secretary to document the obtainment of informed consent;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Read and explain the HIV informed consent form, through an interpreter if necessary, to anyone who cannot read or understand the form’s contents; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Obtain voluntary written informed consent from the patient before an HIV test is performed on a specimen.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>A patient tested at a designated anonymous nonclinical test site, as permitted in Regulation .03 of this chapter, may indicate consent by placing their assigned code on the signature line of the form approved by the Secretary to indicate written informed consent.</text>
  </paragraph>
  <paragraph num="C.">
    <text>Pretest information shall be provided to the patient being tested before each specimen is tested.</text>
  </paragraph>
  <paragraph num="D.">
    <text>An individual providing pretest information shall:</text>
    <paragraph num="(1)">
      <text>Provide HIV-specific information:</text>
      <paragraph num="(a)">
        <text>Verbally;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>In writing;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Through video; or</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Through any combination of §D(1)(a)—(c) of this regulation based on the testing history and information needs of the patient;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Provide HIV information in a manner that protects the confidentiality of the patient;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Using layman’s terms, provide, at a minimum, the following information to the patient:</text>
      <paragraph num="(a)">
        <text>That the patient is being tested for HIV;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>That the patient has the right to:</text>
        <paragraph num="(i)">
          <text>Ask questions; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Decline the test without penalty;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(c)">
        <text>The primary modes of HIV transmission including:</text>
        <paragraph num="(i)">
          <text>Sexual contact without the use of condoms, other barriers, or other biomedical interventions;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Injection drug use; and</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Mother-to-child transmission;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(d)">
        <text>Counseling as defined in Regulation .02 of this chapter to pregnant women;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>That a negative test result means that:</text>
        <paragraph num="(i)">
          <text>A patient is not infected with HIV or that the test was unable to detect the presence of HIV because a patient is in the early stage of infection and has not yet developed detectable evidence of HIV infection; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>If the patient has had any potential recent exposures, that the patient should be retested within an appropriate time frame based on the type of testing used;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(f)">
        <text>That a positive test result means the patient:</text>
        <paragraph num="(i)">
          <text>Is infected with HIV;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Will be linked with medical treatment and other supportive services; and</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>May need a confirmatory test if the preliminary positive was based on an HIV rapid test; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(g)">
        <text>Inform the patient being tested at a designated anonymous HIV test site that an assigned code will be used instead of a name;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>Include an opportunity for the patient to:</text>
      <paragraph num="(a)">
        <text>Ask questions and receive answers about HIV infection and other topics described in this regulation; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Decline HIV testing; and</text>
      </paragraph>
    </paragraph>
    <paragraph num="(5)">
      <text>Make necessary accommodation with respect to language or disability to ensure that the patient understands the information presented.</text>
    </paragraph>
  </paragraph>
</regulation>