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<regulation prefix="Regulation" num=".02" citation="COMAR 10.18.08.02" title_num="10" subtitle_num="18" chapter_num="08" heading="Definitions.">
  <paragraph num="A.">
    <text>In this chapter, the following terms have the meanings indicated.</text>
  </paragraph>
  <paragraph num="B.">
    <text>Terms Defined.</text>
    <paragraph num="(1)">
      <text>“Acquired immunodeficiency syndrome (AIDS)” means the medical condition caused by the human immunodeficiency virus.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>“Anonymous” means that:</text>
      <paragraph num="(a)">
        <text>A patient’s name is not used for identification; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The patient can be identified only through use of an assigned code.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>“Applicant” means a community based organization or other similar agency that seeks approval to become a designated human immunodeficiency virus testing site.</text>
    </paragraph>
    <paragraph num="(4)">
      <text>“Appropriate entity” means the Maryland Department of Health or the Baltimore City Health Department, which designate HIV testing sites in the State per Regulations .03 and .04 of this chapter.</text>
    </paragraph>
    <paragraph num="(5)">
      <text>“Centers for Disease Control and Prevention (CDC)” means the federal Centers for Disease Control and Prevention of the federal Department of Health and Human Services.</text>
    </paragraph>
    <paragraph num="(6)">
      <text>“Confidential” means that a patient’s name is used as identification and that the patient’s medical records contain the patient’s name but are protected against disclosure as provided by statute.</text>
    </paragraph>
    <paragraph num="(7)">
      <text>“Counseling” means providing education to pregnant women on:</text>
      <paragraph num="(a)">
        <text>The effect of a positive HIV test result on the pregnant woman and fetus concerning the risk of transmission of HIV to the fetus; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Recognized methods of reducing the risk of transmission of HIV to the fetus during pregnancy.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(8)">
      <text>“Department” means the Maryland Department of Health.</text>
    </paragraph>
    <paragraph num="(9)">
      <text>“Designated anonymous testing site” means a human immunodeficiency virus testing site approved by the Department or the Baltimore City Health Department as a site where a patient may have an anonymous human immunodeficiency virus test using a code rather than a name for identification.</text>
    </paragraph>
    <paragraph num="(10)">
      <text>“Health care facility” means a facility or office where health or medical care is provided to patients by a health care provider including:</text>
      <paragraph num="(a)">
        <text>A hospital or related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>A freestanding medical facility as defined in Health-General Article, §19-3A-01, Annotated Code of Maryland;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>A health maintenance organization as defined in Health-General Article, §19-701, Annotated Code of Maryland;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>The Department of Public Safety and Correctional Services;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>A program approved by the Department to provide human immunodeficiency virus testing services, according to Regulations .03 and .04 of this chapter;</text>
      </paragraph>
      <paragraph num="(f)">
        <text>A facility operated by the Department or a local health officer; or</text>
      </paragraph>
      <paragraph num="(g)">
        <text>The office of a health care provider.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(11)">
      <text>“Health care provider” means a:</text>
      <paragraph num="(a)">
        <text>Physician;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Nurse;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Licensed direct-entry midwife; or</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Designee of a health care facility.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(12)">
      <text>“Human immunodeficiency virus (HIV)” means a virus that causes AIDS.</text>
    </paragraph>
    <paragraph num="(13)">
      <text>“Indeterminate HIV test result” means that a test did not establish either the presence or absence of HIV infection as defined by the CDC’s laboratory criteria.</text>
    </paragraph>
    <paragraph num="(14)">
      <text>“Informed consent” means the voluntary permission by the patient to be tested for HIV, after the patient receives pretest information as specified in Regulations .06 and .08 of this chapter.</text>
    </paragraph>
    <paragraph num="(15)">
      <text>“Institutional review board” means a group of individuals designated by an institution in compliance with 45 CFR 46, to review the use of human subjects in proposed research.</text>
    </paragraph>
    <paragraph num="(16)">
      <text>“Negative HIV test result” means the test result failed to document the presence of HIV as defined by the CDC’s laboratory criteria.</text>
    </paragraph>
    <paragraph num="(17)">
      <text>Nonclinical Settings.</text>
      <paragraph num="(a)">
        <text>“Nonclinical settings” means locations:</text>
        <paragraph num="(i)">
          <text>That are not health care settings;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Where medical or treatment services are not provided; and</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Where selected diagnostic services and selected prevention services may be provided.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>“Nonclinical settings” may include:</text>
        <paragraph num="(i)">
          <text>Community based organizations;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Outreach settings; or</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Mobile vans.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(18)">
      <text>Partner.</text>
      <paragraph num="(a)">
        <text>“Partner” means an individual with whom one has:</text>
        <paragraph num="(i)">
          <text>Had or will have, oral, anal, or vaginal sexual contact; or</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Shared hypodermic needles or other similar drug paraphernalia.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>“Partner” includes any individual who:</text>
        <paragraph num="(i)">
          <text>Is the marriage partner of an HIV-infected patient; or</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Has been the marriage partner of the HIV-infected patient at any time within the 10-year period before the diagnosis of HIV infection.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(19)">
      <text>“Patient” means any individual who has presented for an HIV test, whether or not the individual chooses to be tested for HIV.</text>
    </paragraph>
    <paragraph num="(20)">
      <text>“Positive HIV test result” means the test result has documented the presence of HIV as defined by the CDC’s laboratory criteria.</text>
    </paragraph>
    <paragraph num="(21)">
      <text>“Post-test information” means notifying a patient about HIV test results and providing a patient with other relevant information after an HIV test has been performed, as required by Regulations .09 and .10 of this chapter.</text>
    </paragraph>
    <paragraph num="(22)">
      <text>“Prenatal care” means obstetric and gynecologic services performed as part of a medical care program for a pregnant woman and her unborn child, and may include:</text>
      <paragraph num="(a)">
        <text>Screening;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Physical examination;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Laboratory and diagnostic testing procedures and interpretation; or</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Counseling.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(23)">
      <text>“Pretest information” means providing a patient with information before a specimen is tested for the presence of HIV infection, as required by Regulations .06 and .08 of this chapter.</text>
    </paragraph>
    <paragraph num="(24)">
      <text>“Research” means an investigation carried out according to a protocol approved by an institutional review board.</text>
    </paragraph>
    <paragraph num="(25)">
      <text>“Secretary” means the Secretary of Health.</text>
    </paragraph>
    <paragraph num="(26)">
      <text>“Seropositive” means that a positive HIV test result has been obtained from the test of a patient’s specimen.</text>
    </paragraph>
    <paragraph num="(27)">
      <text>“Specimen” means a sample of:</text>
      <paragraph num="(a)">
        <text>Blood;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Other body fluid; or</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Body tissue.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(28)">
      <text>“Surrogate consent” means consent given by an individual who is not the patient, as permitted under Health-General Article, §5-605, Annotated Code of Maryland, and other provisions of Maryland law.</text>
    </paragraph>
  </paragraph>
</regulation>