BILL ANALYSIS                                                                                                                                                                                                    



          SENATE COMMITTEE ON
          BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT
                              Senator Jerry Hill, Chair
                                2015 - 2016  Regular 

          Bill No:            AB 2179         Hearing Date:    June 20,  
          2016
           ----------------------------------------------------------------- 
          |Author:   |Gipson                                                |
          |----------+------------------------------------------------------|
          |Version:  |April 14, 2016                                        |
           ----------------------------------------------------------------- 
           ---------------------------------------------------------------- 
          |Urgency:  |No                     |Fiscal:    |Yes              |
           ---------------------------------------------------------------- 
           ----------------------------------------------------------------- 
          |Consultant|Sarah Huchel                                          |
          |:         |                                                      |
           ----------------------------------------------------------------- 
          
                            Subject:  Hepatitis C testing


          SUMMARY:  Authorizes a hepatitis C counselor to perform any hepatitis C  
          virus (HCV) test that is classified as waived under the federal  
          Clinical Laboratory Improvement Act (CLIA), as specified.

          Existing state law:
          
          1)Provides for the licensure, registration, and regulation of  
            clinical laboratories and various clinical laboratory  
            personnel, including cytotechnologists, by the California  
            Department of Public Health (DPH).  (Business and Professions  
            Code (BPC)  1200-1327)

         1)Defines a "clinical laboratory test or examination" as the  
            detection, identification, measurement, evaluation,  
            correlation, monitoring, and reporting of any particular  
            analyte, entity, or substance within a biological specimen for  
            the purpose of obtaining scientific data which may be used as  
            an aid to ascertain the presence, progress, and source of a  
            disease or physiological condition in a human being, or used  
            as an aid in the prevention, prognosis, monitoring, or  
            treatment of a physiological or pathological condition in a  
            human being, or for the performance of nondiagnostic tests for  
            assessing the health of an individual.  (BPC  1206)

         2)Requires an individual who draws blood to be certified by the  
            DPH as a certified phlebotomy technician.  (BPC  1246)







          AB 2179 (Gipson)                                        Page 2  
          of ?
          
          

         3)Allows any person to request, and any licensed clinical  
            laboratory or public health laboratory to perform, the  
            following laboratory tests if the test is waived under CLIA  
            and the laboratory has registered with the DPH: pregnancy,  
            glucose level, cholesterol, occult blood, and any other test  
            for which there is a test for a particular analyte approved by  
            the federal Food and Drug Administration (FDA) for sale to the  
            public without a prescription in the form of an  
            over-the-counter test kit. A test approved only as an  
            over-the-counter collection device may not be conducted  
            pursuant to this section. (BPC  1246.5)

         4)Authorizes an HIV counselor who meets specified requirements to  
            perform any HIV, HCV, or combination HIV/HCV test that is  
            classified as waived under CLIA as specified, and is  
            authorized to perform skin punctures for the purpose of  
            withdrawing blood for a test without being certified as a  
            phlebotomy technician or a limited phlebotomy technician.  
            (Health & Safety Code  120917)


         5)Defines a "local health jurisdiction" (LHJ) as a county health  
            department or combined health department in the case of  
            counties acting jointly or city health department, as  
            specified. (HSC  124030)


          Existing federal law:

          1)Establishes conditions that laboratories must meet for  
            certification to perform testing on human specimens under  
            CLIA.  (Title 42, Code of Federal Regulations (CFR)  493.1)  

          2)Classifies laboratory tests using three categories: "waived,"  
            "moderate complexity," or "high complexity."  (42 CFR  493.5)

          3)Requires tests for certificate of waiver to be simple  
            laboratory examinations and procedures which:

             a)   Are cleared by FDA for home use; 

             b)   Employ methodologies that are so simple and accurate as  
               to render the likelihood of erroneous results negligible;  








          AB 2179 (Gipson)                                        Page 3  
          of ?
          
          
               or 

             c)   Pose no reasonable risk of harm to the patient if the  
               test is performed incorrectly. (42 CFR  493.15)

          This bill:

         1)Authorizes a hepatitis C counselor to perform a HCV test under  
            the overall operation and administration of a laboratory  
            director, as specified.

         2)Requires a hepatitis C counselor to meet one of the following  
            criteria:

             a)   Is trained by the Office of AIDS and working in an HIV  
               counseling and testing site funded by the DPH through a  
               LHJ, or its agents.

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

               i)     Utilizes HIV counseling staff who are trained by the  
                 Office of AIDS or its agents to provide both HIV  
                 counseling and testing and hepatitis C counseling and  
                 testing.

               ii)         Has and retains 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 DPH.

             c)   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, and retained by  
               the site, or approved by the DPH, 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.









          AB 2179 (Gipson)                                        Page 4  
          of ?
          
          
         3)Authorizes a hepatitis C counselor to do all of the following:

             a)   Perform any HCV test that is classified as waived under  
               CLIA if all of the following conditions exist:

               i)     The performance of the HCV test meets the  
                 requirements of state and federal law regarding clinical  
                 labs.  

               ii)         Perform skin punctures for the purpose of  
                 withdrawing blood for waived HCV testing without a  
                 certificate as a certified phlebotomy technician, upon  
                 specific authorization from a licensed physician and  
                 surgeon, provided that the person meets both of the  
                 following requirements:

                  (1)            He or she works under the direction of a  
                    licensed physician and surgeon.

                  (2)            He or she has been trained in rapid test  
                    proficiency for skin puncture blood tests and in  
                    universal infection control precautions, consistent  
                    with best infection control practices established by  
                    the Division of Occupational Safety and Health in the  
                    Department of Industrial Relations and the federal  
                    Centers for Disease Control and Prevention (CDC).

               iii)        The person performing the HCV test meets the  
                 requirements for the performance of waived laboratory  
                 testing, as specified. 

               iv)         The patient is informed that the preliminary  
                 result of the HCV 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  
                 federal CDC for that purpose, a second, different rapid  
                 HCV test. This does not allow a hepatitis C counselor to  
                 perform any HCV test that is not classified as waived  
                 under CLIA.
          
             b)   Order and report HCV test results to patients without  
               authorization from a licensed health care practitioner or  
               his or her authorized representative.  A patient who has an  
               indeterminate or positive test result shall be referred to  








          AB 2179 (Gipson)                                        Page 5  
          of ?
          
          
               a licensed health care practitioner whose scope of practice  
               includes the authority to refer a patient for laboratory  
               testing for further evaluation.

         4)Prohibits a hepatitis C counselor who meets the requirements of  
            this section from performing any other test unless that person  
            meets the statutory and regulatory requirements for performing  
            that other test.

         5)States that compliance with bill does not fulfill any  
            requirements for certification as a phlebotomy technician or a  
            limited phlebotomy technician, unless the hepatitis C  
            counselor has otherwise satisfied the certification  
            requirements.
          
          
          FISCAL  
          EFFECT:  This bill is keyed "fiscal" by the Legislative Counsel.   
          According to the Assembly Committee on Appropriations analysis  
          dated April 27, 2016, this bill has uncertain, potential cost  
          pressures to the DPH.  The analysis notes that this bill does  
          not place direct requirements on the department, but is intended  
          to allow LHJs flexibility to approve and implemented their own  
          training programs.  According to the analysis, DPH 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.

          
          COMMENTS:
          
          1. Purpose.  This bill is sponsored by  Project Inform  .   
             According to the Author's office, 
             "AB 2179 would allow LHJs as well as DPH, to certify training  
             standards for hepatitis C test counselors to administer  
             low-risk, easy-to-use, finger-stick rapid tests that meet the  
             standards for "waiver" under the CLIA. The bill would remove  
             the prerequisite that personnel be trained to administer an  
             HIV rapid test before be trained to administer the hepatitis  
             C rapid test.  Only persons working in sites authorized by  
             LHJs to offer HCV rapid testing would be allowed to  
             administer CLIA-compliant tests.









          AB 2179 (Gipson)                                        Page 6  
          of ?
          
          
             "The California Hepatitis Alliance did a series of interviews  
             with community based programs in California in 2015 and 2016  
             and identified significant barriers to screening at-risk  
             population, even when local resources existed to provide the  
             tests. Even if tests were available and staff was available -  
             either the training was not available or was too distant or  
             too expensive for small community-based programs to access.

             "Current state statute mandates that a person must complete  
             an HIV rapid test counseling training as a prerequisite, even  
             if the local conditions call for deployment of HCV screening.  


             "The State Office of AIDS currently pays contractors to  
             provide HIV and HCV rapid test training, but only offers it  
             to persons from 18 local health jurisdictions that have been  
             prioritized due to high rates of HIV. The prioritization is  
             based on HIV rates, not HCV rates, which is very high in many  
             rural counties.  40 other counties (total of 60 LHJs) may ask  
             for a seat in the trainings, but are wait-listed to see if  
             there will be any availability.

             "The trainings generally take place in San Francisco and Los  
             Angeles, far from programs.  A small community based program,  
             with very tight budgets, assumes the high cost of travel,  
             accommodations, and the loss of staff for 4 days to complete  
             a training that, if the law were changed, could be provided  
             locally in half the time.

             "AB 2179 will trust local health officers and local health  
             departments to certify a training for a test has been judged  
             by the federal government to be easy-to-use, and very  
             low-risk."  

          2. CLIA waived tests.  Federal law, CLIA, establishes conditions  
             that laboratories must meet for certification to perform  
             testing on human specimens.  This law classifies laboratory  
             tests and establishes corresponding regulatory parameters  
             using three categories: "waived," "moderate complexity," and  
             "high complexity."  "Waived" tests constitute the lowest  
             category, and may be granted for those exams and procedures  
             which are cleared by the FDA for home use; employ  
             methodologies that are so simple and accurate as to render  
             the likelihood of erroneous results negligible; or pose no  








          AB 2179 (Gipson)                                        Page 7  
          of ?
          
          
             reasonable risk of harm to the patient if the test is  
             performed incorrectly. 
             
             This bill establishes criteria under which a hepatitis  
             counselor may perform a waived HCV test after training, using  
             a curriculum approved by the local health department, or the  
             DPH, 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.    
          
          3. Hepatitis C.  Hepatitis C is a contagious liver disease that  
             ranges in severity from a mild illness lasting a few weeks to  
             a serious, lifelong illness that attacks the liver.  It  
             results from infection with HCV, which is spread primarily  
             through contact with the blood of an infected person.  While  
             infection rates are high among baby boomers who were exposed  
             to the virus prior to effective blood screenings, most  
             individuals become infected currently by sharing injection  
             equipment.  
             
             Hepatitis C's effects can be mitigated through early  
             detection and treatment, which can also reduce new  
             infections.  This is especially important in California, as  
             the CDC reports that between 2009 and 2013, reported rates of  
             acute hepatitis C increased by 100 percent in this state. 

          4. HIV Counselors.  Existing law allows HIV counselors to  
             perform HIV, HCV, and combination HIV/HCV tests that are  
             classified, as waived under CLIA, if the facility or clinic  
             has obtained a certificate of waiver from Center for Medicaid  
             Services and DPH approval, and the HIV counselor has attended  
             trainings specific to each type of test.  Currently, the  
             Office of AIDS (OA) establishes or approves a LHJ's HIV  
             Counseling and Testing training programs, which are conducted  
             by community-based, non-profit HIV organizations for HIV  
             testing.  However, not all LHJs are able to access the  
             trainings.    

             According to the Office of AIDS Integrated HIV Surveillance,  
             Prevention, and Care Plan (Integrated Plan), budget cuts  
             during fiscal year 2009-10 reduced the OA's funding for many  








          AB 2179 (Gipson)                                        Page 8  
          of ?
          
          
             of its AIDS programs.  Since 2012, the majority of the OA's  
             HIV prevention activities have been funded solely through a  
             five-year funding opportunity from the CDC.  The program  
             established three funding areas in California:  the Los  
             Angeles and San Francisco Metropolitan Statistical Areas  
             (which receive funds directly from the CDC), and the  
             California Project Area (CPA).  The CPA includes a limited  
             number of LHJs that have demonstrated a high incidence of  
             HIV.  LHJs within the CPA receive the Counseling and Testing  
             training as a part of the CDC's program, but the remaining  
             LHJs must pay for the Counseling and Testing training out of  
             their own funds, and spaces within the C&T trainings are  
             limited.

             AB 2179's sponsor and supporters note that having to pay out  
             of pocket for the Counseling and Testing training burdens the  
             LHJs that have not met the HIV-incidence thresholds but may  
             still have a high incidence of HCV.  Currently, the  
             counselors working in LHJs outside of the CPA cannot attend  
             the HCV Counseling and Testing training without attending the  
             HIV Counseling and Testing training.  If the LHJ does not  
             have the funds or the offered training is full, the counselor  
             will be unable to provide HCV testing and screening at the  
             testing site.  This bill seeks to remedy by authorizing a LHJ  
             to approve an independent HCV Counseling and Testing training  
             program and authorizing a hepatitis C counselor who works at  
             a testing site approved by the LHJ to perform a CLIA-waived  
             HCV test after attending the training program.  

          5. Prior Related Legislation.   AB 1382  (R. Hernandez, Chapter  
             643, Statutes of 2011) authorized HCV training for HIV test  
             counselors. 

              AB 221  (Portantino, Chapter 421, Statutes of 2009) among  
             other things, removed the HIV counselor training equivalency  
             credit towards a limited phlebotomy technician certification  
             and instead exempted an HIV counselor who works under a  
             licensed physician and surgeon, and who is trained in rapid  
             HIV test proficiency and universal infection control  
             precautions, from the requirement that he or she hold a valid  
             certification as a phlebotomist technician.  

              AB 685  (Leno, Chapter 2, Statutes of 2004) provided that HIV  
             counselors that completed HIV counselor training were deemed  








          AB 2179 (Gipson)                                        Page 9  
          of ?
          
          
             to have met the requirements for certification as a limited  
             phlebotomy technician.   

              AB 1263  (Migden, Chapter 324, Statutes of 2001) among other  
             things, authorized HIV counselors to perform HIV tests  
             classified as waived under CLIA.

          6. Arguments in Support.   Project Inform  writes, "California  
             must 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.     
             Current state law allows non-medical personnel to administer  
             HCV rapid tests in compliance with federal standards under  
             CLIA, but only if personnel are working at a DPH Office of  
             AIDS (OA)-funded site, or authorized by a local health  
             jurisdiction (LHJ); have been trained in HIV testing and  
             counseling using a DPH-OA approved curriculum; and have  
             completed an additional HCV test counseling and testing  
             module approved by DPH-OA. 

             "AB 2179 would allow LHJs, as well as DPH, to certify  
             training standards for HCV rapid test counselors, and remove  
             the prerequisite that personnel be trained to administer an  
             HIV rapid test before learning to administer the HCV rapid  
             test. Further, only those persons working in sites authorized  
             by LHJs to offer HCV rapid testing would be allowed to  
             administer CLIA-compliant tests."

              Access Support Network  writes that they were recently able to  
             train 16 local individuals to become HIV/HCV Test Counselors.  
              "The training was a four day training that came at a cost of  
             nearly $40,000 to our agency.  We were fortunate to have one  
             time funding to facilitate this training, but, not normally  
             being funded by the State Office of AIDS HIV testing, this  
             training will not be available again for our agency.  A more  
             simplified training for HCV test counselors is greatly  
             needed."

              Mendocino County AIDS/Viral Hepatitis Network (MCAVHN)  writes  
             that they are the "only HIV/AIDS/HCV service-oriented,  
             community based harm reduction organization in all of  
             Mendocino County?. MCAVHN began outreach efforts in the  
             mid-nineties, notably building bridges within the  








          AB 2179 (Gipson)                                        Page 10  
          of ?
          
          
             Native-American communities who were significantly  
             under-represented.  Our services have adapted to assist those  
             with multiple co-morbid conditions, and within Mendocino  
             County our persons who inject drugs have a projected HCV+  
             rate of 85%.  We are the only community-based organization  
             delivering HCV testing to persons within our syringe exchange  
             services delivery, both in-house and in the field, and have  
             just been informed that we can no longer provide this service  
             due to the conditions of the SAPTBG funding stream, which for  
             the past two years has been our only source of funding for  
             this testing....

             "AB 2179 would allow LHJs to certify training standards for  
             HCV rapid test counselors and remove the prerequisite that  
             personnel be trained to administer an HIV rapid test before  
             learning to administer the HCV rapid test.  Further, only  
             those persons working in sites authorized by LHJs to offer  
             HCV rapid testing would be allowed to administer  
             CLIA-compliant tests.  These trainings need to be available  
             and low-cost so that communities can deliver these services  
             even in resource-poor, rural areas."

          7. Technical Amendment.  The following are suggested technical  
             amendments to strike code that was amended by the inclusion  
             of text explicitly authorizing a hepatitis C counselor to  
             perform a HCV test under the overall operation and  
             administration of a laboratory director, as specified.

             On page 7, line 36, delete everything after "Code."

             On page 7, delete lines 37-39.

             On page 8, delete lines 1-2

          
           NOTE  :  Double-referral to Senate Committee on Health , second.
          

          SUPPORT AND OPPOSITION:
          
           Support:  

          Project Inform (Sponsor)
          Access Support Network








          AB 2179 (Gipson)                                        Page 11  
          of ?
          
          
          AIDS Community Research Consortium
          Asian Pacific Health Foundation
          Bay Area Black Nurses Association
          California Black Health Network
          California Chronic Care Coalition
          California Hepatitis Alliance
                                                                                     California Life Sciences Association
          Comprehensive Opiate Recovery Experience Medical Clinic, Inc. 
          Desert AIDS Project
          Drug Policy Alliance
          Harm Reduction Coalition
          Health Officers Association of California
          HIV Education and Prevention Project of Alameda County
          Mendocino County AIDs/Viral Hepatitis Network
          Sacramento Area Task Force for the Outreach and Prevention of  
          Hepatitis
          San Francisco Hepatitis C Task Force
          The Wall Las Memorias Project
          One individual

           Opposition:  

          None on file as of June 14, 2016.

                                      -- END --