BILL NUMBER: AB 1263 CHAPTERED 09/24/01 CHAPTER 324 FILED WITH SECRETARY OF STATE SEPTEMBER 24, 2001 APPROVED BY GOVERNOR SEPTEMBER 23, 2001 PASSED THE ASSEMBLY AUGUST 30, 2001 PASSED THE SENATE AUGUST 27, 2001 AMENDED IN SENATE AUGUST 22, 2001 AMENDED IN SENATE JULY 12, 2001 AMENDED IN ASSEMBLY MAY 15, 2001 AMENDED IN ASSEMBLY MAY 3, 2001 INTRODUCED BY Assembly Member Migden FEBRUARY 23, 2001 An act to add Section 120917 to the Health and Safety Code, relating to health care. LEGISLATIVE COUNSEL'S DIGEST AB 1263, Migden. AIDS: HIV: rapid testing programs. Existing law makes provision for various programs relating to treatment of persons with the human immunodeficiency virus (HIV) and the acquired immune deficiency syndrome (AIDS). This bill would authorize the State Department of Health Services to participate in a rapid immunodeficiency virus test research program conducted with the federal Centers for Disease Control and Prevention, involving innovative HIV testing and counseling programs. The bill would additionally authorize the department to implement a rapid HIV test program in testing sites designated by the department, using specified tests, and in accordance with specified criteria. THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS: SECTION 1. The Legislature finds and declares as follows: (a) Approximately 25 million persons each year in the United States are tested for antibody to human immunodeficiency virus (HIV). (b) Publicly funded counseling and testing programs conduct approximately 2.5 million of these tests each year. (c) Standard HIV testing protocols typically involve a pretest risk assessment counseling session, during which a blood or oral specimen is obtained and sent to a laboratory for laboratory testing. A posttest appointment is scheduled for one to two weeks after the initial counseling session when the test results are disclosed to the patient. (d) Annually, 25 percent of persons testing HIV positive, and 33 percent of persons testing HIV negative at publicly funded clinics did not return for their test results. (e) Using a rapid test for detecting antibody to HIV (rapid HIV test) to provide results on the day of testing can increase the number of persons who learn their HIV status and also reduce the field efforts necessary to locate and counsel HIV-positive persons who do not return. (f) A rapid HIV test is a screening test that produces results quickly enough to allow for same-day results to be given to the patient. The use of a rapid HIV test with same-day results for HIV screening in clinical-care settings can substantially improve the delivery of counseling and testing program services. Informing patients of their HIV-negative status is beneficial, because they can receive counseling to modify behavior to reduce the future risk of contracting HIV and learn their HIV status in a single visit. In addition, providing positive results also increases the number of infected persons who ultimately learn their infection status and can be referred for medical treatment and additional prevention services. (g) Decisions about whether to use rapid HIV tests should be based on a combination of prevalence of HIV in the community and return rates for test results. For example, in settings of high prevalence where a low percentage of persons return for their results, use of rapid HIV tests will be most beneficial. SEC. 2. Section 120917 is added to the Health and Safety Code, to read: 120917. (a) The department, through its Office of AIDS and the authorized agents of the office, may participate in a rapid human immunodeficiency virus test research program conducted with the federal Centers for Disease Control and Prevention, involving innovative HIV testing and counseling programs. Under the rapid HIV test research program, as authorized by this section, the department may do the following: (1) Perform and report clinical test results using a rapid HIV test for diagnosis, prior to test approval by the federal Food and Drug Administration (FDA). However, test performance and reporting shall only be done to the extent allowed under that device's investigational approval by the FDA and pursuant to a California Health and Human Services Agency Institutional Review Board-approved research protocol. (2) Use a second independent HIV test to confirm initially reactive test results to the extent allowed under the investigational approval by the FDA. All rapid tests shall be confirmed using technology approved by the federal Food and Drug Administration. If the results from this confirmatory testing differ from the results of the rapid test, the subject shall be notified. No subject shall participate in the research protocol who does not provide appropriate contact information. (b) An HIV counselor who is trained by the Office of AIDS and working in an HIV counseling and testing site funded by the department through a local health jurisdiction, or its agents, may do all of the following: (1) Perform any HIV test that is classified as waived under the federal Clinical Laboratory Improvement Act (CLIA; 42 U.S.C. Sec. 263a and following) if all of the following conditions exist: (A) The performance of the HIV test meets the requirements of CLIA and Chapter 3 (commencing with Section 1200) of Division 2 of the Business and Professions Code. (B) The person performing the HIV test meets the requirements for the performance of waived laboratory testing pursuant to subdivision (a) of Section 1206.5 of the Business and Professions Code. For purposes of this subdivision and subdivision (a) of Section 1206.5 of the Business and Professions Code, an HIV counselor trained by the Office of AIDS shall be "other health care personnel providing direct patient care" as referred to in paragraph (12) of subdivision (a) of Section 1206.5 of the Business and Professions Code. (C) Prior to informing a patient of a test result indicative of HIV infection that was performed pursuant to this paragraph, a second independent HIV test is performed to confirm initially reactive test results. Nothing in this subdivision shall be construed to allow an HIV counselor trained by the Office of AIDS to perform any HIV test that is not classified as waived under the CLIA. (2) Notwithstanding Sections 1246.5 and 2053 of the Business and Professions Code, order and report HIV test results from tests performed pursuant to paragraph (1) to patients without authorization from a licensed health care professional or his or her authorized representative. Patients with indeterminate or positive test results from tests performed pursuant to paragraph (1) shall be referred to a licensed health care provider whose scope of practice includes the authority to refer patients for laboratory testing for further evaluation.