BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                      



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          |SENATE RULES COMMITTEE            |                  AB 1382|
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                                 THIRD READING


          Bill No:  AB 1382
          Author:   Roger Hernández (D)
          Amended:  7/7/11 in Senate
          Vote:     21

           
           SENATE HEALTH COMMITTEE  :  8-0, 6/29/11
          AYES:  Hernandez, Strickland, Alquist, Anderson, Blakeslee, 
            De León, DeSaulnier, Wolk
          NO VOTE RECORDED:  Rubio

           SENATE APPROPRIATIONS COMMITTEE  :  9-0, 8/25/11
          AYES:  Kehoe, Walters, Alquist, Emmerson, Lieu, Pavley, 
            Price, Runner, Steinberg

           ASSEMBLY FLOOR  :  78-0, 5/19/11 (Consent) - See last page 
            for vote


           SUBJECT  :    HIV counselors

           SOURCE  :     Author


           DIGEST  :    This bill permits HIV counselors to perform skin 
          punctures for hepatitis C virus (HCV) tests, or combination 
          HIV/HCV test, under specified conditions.

           ANALYSIS  :    

           Existing federal law  :

          1. Establishes quality standards for all laboratory testing 
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             under the Clinical Laboratory Improvement Amendments 
             (CLIA) in 1988.  Classifies tests according to their 
             complexity.

          2. Waives certain tests from CLIA requirements when those 
             tests use direct, unprocessed specimens (such as whole 
             blood or oral fluid), can be easily performed with a 
             negligible chance of error, and can be performed by 
             persons without formal laboratory training outside of 
             traditional laboratories.

           Existing state law  :

          1. Requires that HIV counselors, who provide information 
             and resources about HIV testing, treatment, and 
             counseling, either be:

             A.    Trained by the California Department of Public 
                Health (CDPH) Office of AIDS (OA) and working in an 
                HIV counseling and testing (C&T) site funded by 
                CDPH.

             B.    Working in an HIV C&T site that uses HIV 
                counselors who are trained by CDPH/OA or its agents 
                and that complies with a quality assurance plan 
                approved by the local health department.

          2. Permits HIV counselors, meeting one of the 
             abovementioned criteria, to do the following:

             A.    Perform any CLIA-waived HIV test, provided the 
                test meets CLIA requirements and provided the 
                person meets the requirements for the performance 
                of waived laboratory testing.

             B.    Perform skin punctures to withdraw blood for an 
                HIV test, provided the counselor is authorized and 
                working under the direction of a licensed 
                physician and surgeon, and provided the counselor 
                has been trained in oral swab tests, skin puncture 
                tests, and universal infection control 
                precautions. 

          3. Allows HIV counselors to order and report test results 

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             to patients without authorization from a licensed health 
             care professional

          4. Requires that the patient be informed that the 
             preliminary result of the HIV test is indicative of the 
             likelihood of infection, and the results must be 
             confirmed with additional testing.

          5. Requires that patients with indeterminate or positive 
             test results be referred to an appropriate licensed 
             heath care provider. 

          6. Requires HIV counselors to receive specified training.  
             Prohibits HIV counselors from performing skin punctures 
             until training is complete, with specified exceptions.

          7. Clarifies that these provisions do not authorize HIV 
             counselors to act as phlebotomy technicians. 

          This bill permits HIV counselors who are authorized under 
          existing law to perform skin punctures to administer an HIV 
          test, to also perform skin punctures for HCV tests or 
          combination HIV/HCV tests.  

           Background
           
           HCV  .  HCV infection is the most common chronic blood borne 
          infection in the United States. Approximately 3.2 million 
          persons are chronically infected nationwide, and about 
          17,000 people are newly infected each year, according to 
          the Centers for Disease Control and Prevention (CDC).  HCV 
          is associated with an estimated 12,000 deaths annually.  
          Approximately 75 to 85 percent of people who become 
          infected with HCV will develop chronic infections.  In 
          California, HCV affects approximately 600,000 people, or 
          two percent of the state's population, according to 
          CDPH/OA.  Chronic HCV can have a wide range of outcomes, 
          most significant liver failure.  Symptoms associated with 
          HCV infection, including fatigue, abdominal bloating, 
          flu-like symptoms, and jaundice, are present in only 0 to 
          30 percent of cases; therefore, most infections go 
          undiagnosed until liver disease develops 20 to 30 years 
          later.


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           HCV and HIV  .  CDPH/OA estimates that 50 to 80 percent of 
          injection drug users (IDUs) who are HIV-

          positive are also infected with HCV.  Both HIV and HCV are 
          transmitted by exposure to infected blood, and both can be 
          prevented by decreasing exposure to infected blood, for 
          example by using new sterile syringes and not sharing 
          injection equipment.  Although HCV is not efficiently 
          transmitted sexually, persons at risk for infection through 
          injection drug use might seek care in facilities that treat 
          sexually transmitted diseases (STDs), HIV C&T facilities, 
          correctional facilities, drug treatment facilities, and 
          other public health settings where STD and HIV prevention 
          and control services are available. Unlike HIV, HCV can 
          potentially be cured by an infected individual's own immune 
          system or by medical treatment. HCV progresses more quickly 
          in people who are co-infected with HIV, and HCV treatment 
          is less successful in HIV-positive people than in 
          HIV-negative people.  
           
           C&T for HIV and HCV  .  According to CDPH/OA, offering HCV 
          testing in conjunction with HIV C&T has proven to be an 
          effective prevention strategy for identifying infected 
          individuals and providing referrals for treatment. Results 
          from an HCV C&T demonstration project in 2003 included the 
          following:

           HIV testing rates among IDUs nearly doubled when HIV C&T 
            was offered in conjunction with HCV C&T.

           HIV test disclosure return rates increased by 21 percent 
            among IDUs when individuals were able to receive both 
            their HCV and HIV test results.

           IDUs were more interested in their HCV status than their 
            HIV status.

          In January 2008, CDPH/OA integrated HCV testing into its 
          HIV C&T program as an optional service that local health 
          jurisdictions could provide to those at risk for HCV 
          infection. Currently, CDPH/OA HIV test counselors assist 
          the client with using a self-administered HCV antibody 
          fingerstick test. The current HCV testing technology 
          requires that the client return after two weeks to receive 

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          his or her test results.  

          CDPH/OA has also developed an online HCV training program 
          designed to provide information regarding HCV infection, 
          transmission, and screening, and to provide limited 
          information regarding clinical management and treatment for 
          people with HCV infection. The primary emphasis of the 
          training is on counseling people who are at risk or already 
          infected with HCV, and providing appropriate referrals. Of 
          the approximately 362 CDPH/OA HIV test counselors that are 
          currently certified, 121 have completed this online 
          training.

           HCV rapid test  .  On June 25, 2010, the U.S. Food and Drug 
          Administration announced approval of the first rapid blood 
          test for HCV antibodies for individuals age 15 and older.  
          The HCV rapid antibody test is used to test individuals who 
          are at risk for infection with HCV and people with signs or 
          symptoms of hepatitis, but is not approved for use in the 
          general population. HCV rapid test kits, also known as 
          one-step HCV tests, use a portable device and test strips 
          to detect HCV antibodies in samples from oral fluid, 
          fingerstick/venipuncture whole blood, or collected 
          serum/plasma.  Results are given in about 20 to 40 minutes 
          as either reactive or nonreactive. 

          With these HCV antibody test devices, if results are shown 
          as reactive, this could mean the person has a short-term 
          infection and will get better on their own, the person has 
          a long-term infection and is at risk for developing 
          cirrhosis or liver cancer later in life, the person was 
          infected in the past but is no longer infected, or that the 
          test produced a false positive result.  The only way that a 
          person with a positive test can know if he/she is currently 
          infected is to have a follow-up medical evaluation and 
          blood test under the administration of a physician. 

          Approval of this rapid test means that more patients can be 
          notified of their HCV exposure faster so that they can 
          consult with their physician for appropriate health 
          measures.  Rapid tests provided at the point-of-care can 
          also make HCV testing accessible in locations with limited 
          laboratory facilities and greatly reduce the number of 
          persons who do not return for their test results.

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           FISCAL EFFECT  :    Appropriation:  No   Fiscal Com.:  Yes   
          Local:  No

          According to the Senate Appropriations Committee:

                          Fiscal Impact (in thousands)

           Major Provisions                2011-12     2012-13    
           2013-14   Fund  

          Increased treatment of                       Unknown, 
          potentially significant                      General/
          Individuals with HIV                              Federal/
          And Hepatitis C                                   Local

           SUPPORT  :   (Verified  8/25/11)

          California Department of Public Health
          California Hepatitis Alliance
          Drug Policy Alliance
          Harm Reduction Coalition
          Los Angeles County Board of Supervisors


           ARGUMENTS IN SUPPORT  :    The County of Los Angeles believes 
          that allowing HIV counselors to also administer HCV or 
          HCV/HIV tests increases the availability of HCV screenings. 
           They believe early detection is important to increasing 
          the number of individuals who enter treatment, results in 
          better outcomes for patients, and reduces health care costs 
          for undetected HCV infections.  CDPH claims that allowing 
          HIV counselors to administer a rapid, oral HCV test would 
          help overcome key challenges they face by providing clients 
          with same-day results.  CDPH also believes AB 1382 would 
          increase the number of persons with HCV antibody who 
          receive counseling and referrals, decrease the risk of 
          additional infections, and allow HCV-infected clients to 
          access earlier care. 


           ASSEMBLY FLOOR  : 
          AYES: Achadjian, Allen, Ammiano, Atkins, Beall, Bill 
            Berryhill, Block, Blumenfield, Bonilla, Bradford, 

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            Brownley, Buchanan, Butler, Charles Calderon, Campos, 
            Carter, Cedillo, Chesbro, Conway, Cook, Davis, Dickinson, 
            Donnelly, Eng, Feuer, Fletcher, Fong, Fuentes, Furutani, 
            Beth Gaines, Galgiani, Garrick, Gatto, Gordon, Grove, 
            Hagman, Halderman, Hall, Harkey, Hayashi, Roger 
            Hernández, Hill, Huber, Hueso, Huffman, Jeffries, Jones, 
            Knight, Lara, Logue, Bonnie Lowenthal, Ma, Mansoor, 
            Mendoza, Miller, Mitchell, Monning, Morrell, Nestande, 
            Nielsen, Norby, Olsen, Pan, Perea, V. Manuel Pérez, 
            Portantino, Silva, Skinner, Smyth, Solorio, Swanson, 
            Torres, Valadao, Wagner, Wieckowski, Williams, Yamada, 
            John A. Pérez
          NO VOTE RECORDED: Alejo, Gorell


          CTW:do  8/29/11   Senate Floor Analyses 

                         SUPPORT/OPPOSITION:  SEE ABOVE

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