Approved HIV Tests and Testing Procedures

Section 697 Section 697.100  Approved HIV Tests and Testing Procedures a)         Any person, laboratory, blood bank, hospital or other entity that conducts laboratory tests to detect the presence of HIV infection shall use an approved HIV test as defined in this Part. (See Section 697.20.) 1)         Supplemental testing shall be completed before HIV test results are released to the health care professional or other individuals authorized to receive the results as described and limited in Section 697.140, except in the following situations: A)        When immediate medical treatment is necessary to prevent further transmission of HIV to a newborn infant in labor, delivery and postpartum settings.  For the purposes of this subsection (a)(1), immediate medical treatment, for a newborn infant, means upon delivery or within 48 hours after the infant's birth .  (Section 10 of the Perinatal HIV Prevention Act)  Treatment shall be conducted as provided by the Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States (see Section 697.30); B)        In instances of occupational exposure, as provided by Section 697.140(a)(8) and (9); or C)        At the time of testing, provided that the subject of the test or the subject's legally authorized representative has received pre-test information, has been informed of his/her right to refuse testing, and has provided consent to be tested and to receive a preliminary test result in accordance with Sections 697.110 and 697.120, except in the case of a newborn infant as provided in the Perinatal HIV Prevention Act. 2)         Before testing is conducted under subsection (a)(1)(A) or (B) (C), the subject of the test or the subject's legally authorized representative shall receive pre-test information and shall have provided specific written or verbal informed consent to be tested and to receive a preliminary test result in accordance with Sections 697.110 and 697.120, except in the case of a newborn infant as provided in the Perinatal HIV Prevention Act. The provision of pre-test information and informed consent shall be documented in the patient's medical record or as part of the consent form for medical care or HIV testing completed by the patient. 3)         In the exceptions described in subsection (a)(1)(A) or (B) , a preliminary test result may be released to persons specified in Section 697.140(a)(1), (2), (3), (8), or (9). 4)         Any release of preliminary positive results from HIV tests shall include a disclaimer that an HIV infection has not been diagnosed and cannot be diagnosed without supplemental testing. b)         HIV testing shall be a routine part of general medical care, as recommended by the United States Centers for Disease Control and Prevention, Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings. c)         The Department will conduct training, technical assistance, and outreach activities, as needed, to encourage routine opt-out HIV testing in health care settings.