BILL ANALYSIS                                                                                                                                                                                                    Ó

                                                                    AB 2179

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          2179 (Gipson)

          As Amended  April 14, 2016

          Majority vote

          |Committee       |Votes|Ayes                  |Noes                |
          |                |     |                      |                    |
          |                |     |                      |                    |
          |                |     |                      |                    |
          |Business &      |16-0 |Salas, Brough, Baker, |                    |
          |Professions     |     |Bloom, Campos,        |                    |
          |                |     |Chávez, Dahle, Dodd,  |                    |
          |                |     |Burke, Gatto, Gomez,  |                    |
          |                |     |Holden, Jones,        |                    |
          |                |     |Mullin, Ting, Wood    |                    |
          |                |     |                      |                    |
          |Health          |19-0 |Wood, Maienschein,    |                    |
          |                |     |Bonilla, Burke,       |                    |
          |                |     |Campos, Chiu,         |                    |
          |                |     |Dababneh, Gomez,      |                    |
          |                |     |                      |                    |
          |                |     |                      |                    |
          |                |     |Roger Hernández,      |                    |
          |                |     |Lackey, Nazarian,     |                    |
          |                |     |Olsen, Patterson,     |                    |
          |                |     |Ridley-Thomas,        |                    |
          |                |     |Rodriguez, Santiago,  |                    |
          |                |     |Steinorth, Thurmond,  |                    |


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          |                |     |Waldron               |                    |
          |                |     |                      |                    |
          |Appropriations  |20-0 |Gonzalez, Bigelow,    |                    |
          |                |     |Bloom, Bonilla,       |                    |
          |                |     |Bonta, Calderon,      |                    |
          |                |     |Chang, Daly, Eggman,  |                    |
          |                |     |Gallagher, Eduardo    |                    |
          |                |     |Garcia, Roger         |                    |
          |                |     |Hernández, Holden,    |                    |
          |                |     |Jones, Obernolte,     |                    |
          |                |     |Quirk, Santiago,      |                    |
          |                |     |Wagner, Weber, Wood   |                    |
          |                |     |                      |                    |
          |                |     |                      |                    |

          SUMMARY:  Authorizes a hepatitis C counselor, who meets  
          specified training requirements and works in specified testing  
          sites, to perform hepatitis C virus (HCV) tests classified as  
          waived under the federal Clinical Laboratory Improvement  
          Amendments of 1988 (CLIA).  Specifically, this bill:

          1)Authorizes a hepatitis C counselor to perform a HCV test that  
            is classified as waived under CLIA if the following conditions  
             a)   The performance of the HCV test meets the requirements  
               of CLIA and California's clinical laboratory requirements;
             b)   The counselor meets one of the following training and  
               workplace requirements:

               i)     Is trained by the California Department of Public  
                 Health's (CDPH's) Office of Aids (OA) and is working in a  
                 HIV counseling and testing site funded by the CDPH  
                 through a local health jurisdiction (LHJ), or its agents;  


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               ii)Is working in a HIV counseling and testing site that  
                 meets both of the following criteria:

                  (1)Utilizes HIV counseling staff trained by the OA or  
                    its agents to provide both HIV counseling and testing  
                    and hepatitis C counseling and testing; and,
                  (2)Has a quality assurance plan approved by the local  
                    health department in the jurisdiction where the site  
                    is located and has HIV counseling and testing staff  
                    who comply with the quality assurance requirements as  
                    specified by the CDPH; or, 

               iii)Is working at a site approved by the local health  
                 department to provide hepatitis C rapid testing and  
                 counseling, and has been trained using a curriculum  
                 approved by the local health department or the CDPH,  
                 which, at a minimum, provides training in universal  
                 precautions, safe working conditions, proper running and  
                 reading of hepatitis C rapid test kit technology, and  
                 providing accurate information to clients including the  
                 importance of confirmatory tests, linkages to medical  
                 care, and the prevention of hepatitis C transmission; 
             c)   The HCV test is performed under the overall operation  
               and administration of a laboratory director.  Defines, for  
               purposes of this requirement, an HIV counselor who meets  
               the specified requirements as "other health care personnel  
               providing direct patient care" under California's clinical  
               laboratory requirements;
             d)   The patient is informed that the preliminary result of  
               the test is indicative of the likelihood of HCV exposure  
               and that the result must be confirmed by an additional,  
               more specific test, or, if approved by the Center for  
               Disease Control and Prevention (CDC) for that purpose, a  
               second, different rapid HCV test; and,

             e)   If performing a skin punctures for the purpose of  


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               withdrawing blood for HCV testing, the counselor must meet  
               the following additional requirements:

               i)     Work under the direction of a licensed physician and  
               ii)Obtain specific authorization from a licensed physician  
                 and surgeon; and, 

               iii)Be trained in rapid test proficiency either for skin  
                 puncture blood tests or oral swab tests in universal  
                 infection control precautions, consistent with best  
                 infection control practices established by the Division  
                 of Occupational Safety and Health (DOSH) in the  
                 Department of Industrial Relations (DIR) and the CDC.

          2)Authorizes the counselor to order and report the results from  
            the HCV tests performed to a patient without authorization  
            from a licensed health care practitioner or the patient's  
            authorized representative.  
          3)Requires the counselor to refer a patient who has an  
            indeterminate or positive test result to a licensed health  
            care practitioner whose scope of practice includes the  
            authority to refer a patient for laboratory testing for  
            further evaluation.

          4)Provides that a hepatitis C counselor is not authorized to  
            perform any other test unless that person meets the statutory  
            and regulatory requirements for performing the other test,  
            including those requiring certifications in phlebotomy.

          FISCAL EFFECT:  According to the Assembly Appropriations  
          Committee, uncertain, potential cost pressure to the CDPH.  This  
          bill does not place direct requirements on the department, but  
          is intended to allow local health jurisdictions (LHJs)  


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          flexibility to approve and implemented their own training  
          programs.  However, CDPH indicates cost pressure in the hundreds  
          of thousands of dollars to promulgate and implement regulations,  
          provide technical assistance, and review, approve, and  
          potentially implement Hepatitis C counselor trainings.    


          Purpose.  This bill is sponsored by Project Inform.  According  
          to the author, "The unchecked spread of HCV threatens the public  
          health and economic welfare of California.  It is necessary that  
          California reduce the costs and procedural barriers for training  
          non-medical personnel to perform rapid HCV tests in order that  
          local health departments can respond in a manner that is safe  
          and appropriate to the urgency of the epidemic.  [This bill]  
          will give local health departments greater flexibility to  
          respond to HCV in their communities and reduce costs related to  
          training non-medical personnel to administer the rapid test."

          Background.  Hepatitis means inflammation of the liver.   
          Hepatitis C is an infection of the liver caused by HCV, one of  
          several contagious viruses that can cause hepatitis.  HCV is  
          spread by blood-to-blood contact and common ways people become  
          infected are through needle sharing, inadequate sterilization of  
          medical equipment, and unscreened blood transfusions.

          The CDC estimates that there are 3.5 million people in the US  
          have chronic HCV infection. Between 1994 and 2011, the CDPH had  
          received 501,664 newly reported chronic HCV cases in California.  
           As a result, the World Health Organization, the CDC, and the  
          CDPH suggest policies that promote prevention and education  
          among high-risk populations.  This bill seeks to do so by  
          authorizing HCV counselors to perform a HCV screening test if it  
          is classified as waived under CLIA.  The author states that  
          doing so will increase access to HCV counselors, who will  


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          promote prevention by providing screening and education services  
          at a community level.

          Federal and State Laboratory Requirements.  Under the federal  
          CLIA law, laboratories that perform tests on human specimens  
          must be certified by the Centers for Medicare and Medicaid  
          Services (CMS).  The requirements for CLIA certification vary  
          depending on the complexity of the laboratory tests performed.   
          The three complexities are waived, moderate, and high  
          complexity.  In general, the more complicated the test, the more  
          stringent the requirements under CLIA.  Waived tests are simple,  
          consumer-level tests with a low risk for an incorrect result.   
          However, California law only allows specified personnel to  
          perform waived tests on others.

          HIV and HCV Counselors.  Existing law allows HIV counselors to  
          perform HIV, HCV, and combination HIV/HCV tests as long as the  
          tests are classified as waived under CLIA, the facility or  
          clinic has obtained a certificate of waiver from CMS and CDPH  
          approval, and the HIV counselor has attended a Counseling and  
          Testing (C&T) training specific to each type of test.  

          Currently, the OA either establishes or approves  
          federally-funded HIV C&T training programs for a LHJ's HIV  
          counselors.  However, not all LHJs are able to access the  
          trainings.  Access to the trainings is determined by incidence  
          of HIV, but some LHJs have a high incidence of HCV but not a  
          high incidence of HIV.  The LHJs that cannot meet the HIV  
          thresholds must pay for the trainings. 

          The sponsor notes that having to pay out of pocket for the C&T  
          training means that if the LHJ does not have the funds or the  
          offered training is full, its counselors will not be able to  
          provide necessary HCV testing and screenings.  This bill seeks  
          to remedy this issue in two ways:  1) authorizing a LHJ to  


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          approve a HCV C&T training program and 2) authorizing a HCV  
          counselor who works at a testing site approved by the LHJ to  
          perform a CLIA-waived HCV test after attending the training  

          Analysis Prepared by:                                             
                          Vincent Chee / B. & P. / (916) 319-3301  FN: