BILL ANALYSIS                                                                                                                                                                                                    ”



           SENATE COMMITTEE ON HEALTH
                          Senator Ed Hernandez, O.D., Chair

          BILL NO:                    AB 2179             
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          |AUTHOR:        |Gipson                                         |
          |---------------+-----------------------------------------------|
          |VERSION:       |June 22, 2016                                  |
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          |HEARING DATE:  | June 29, 2016 |               |               |
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          |CONSULTANT:    |Melanie Moreno                                 |
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           SUBJECT :  Hepatitis C testing

           SUMMARY  :  Authorizes a hepatitis C counselor who meets specific  
          requirements to perform any hepatitis C virus (HCV) test that is  
          classified as waived under the federal Clinical Laboratory  
          Improvement Act.
          
          Existing federal law:
          1)Defines "laboratory" or "clinical laboratory" (lab or clinical  
            lab) as a facility for the biological, microbiological,  
            serological, chemical, immuno-hematological, hematological,  
            biophysical, cytological, pathological, or other examination  
            of materials derived from the human body for the purpose of  
            providing information for the diagnosis, prevention, or  
            treatment of disease or impairment or health assessment of  
            human beings.  

          2)Requires labs to obtain a certificate, meet quality standards,  
            and undergo inspections, among other things, before accepting  
            materials derived from the human body.  Exempts laboratories  
            with a certificate of waiver from the Clinical Laboratory  
            Improvement Amendments (CLIA), provided that the laboratory  
            follows the manufacturer's instructions. 

          3)Provides that a lab is eligible for a certificate of waiver if  
            it only performs "waived tests," which are simple examinations  
            and procedures that: 

                  a)        Have been approved by the Food and Drug  
                    Administration (FDA) for home use;
                  b)        The FDA has determined are so simple and  
                    accurate that there is a negligible chance of  
                    erroneous results; or, 







          AB 2179 (Gipson)                                   Page 2 of ?
          
          
                  c)        Pose no unreasonable risk of harm to the  
                    patient if performed incorrectly.  

          4)Authorizes a state to enact and enforce laws relating to CLIA  
            to the extent that the state laws are not inconsistent with  
            the CLIA laws and regulations.  
            
          Existing state law:
          1)Provides for the licensure, registration, and regulation of  
            clinical labs and various clinical lab personnel by the  
            Department of Public Health (DPH).

          2)Prohibits a person from performing a clinical lab test or  
            examination classified as waived under CLIA unless the  
            clinical lab test or examination is performed under the  
            overall operation and administration of the lab director, as  
            specified, and the test is performed by one the following  
            persons if within the person's scope of practice:  

                  a)        A licensed physician and surgeon holding a  
                    M.D. or D.O. degree;
                  b)        A licensed podiatrist, a licensed dentist, or  
                    a licensed naturopathic doctor;
                  c)        A person licensed in California to engage in  
                    clinical laboratory practice or to direct a clinical  
                    laboratory;
                  d)        A person authorized by a local health  
                    laboratory to perform tests pursuant to a certificate  
                    issued by the DPH;
                  e)        A licensed physician assistant;
                  f)        A licensed nurse;
                  g)        A licensed vocational nurse;
                  h)        A certified perfusionist (a specialized  
                    healthcare professional who uses the heart-lung  
                    machine during cardiac surgery and other surgeries  
                    that require cardiopulmonary bypass to manage the  
                    patient's physiological status);
                  i)        A licensed respiratory care practitioner;
                  j)        A medical assistant;
                  aa)       A pharmacist;
                  bb)       A naturopathic assistant;
                  cc)       A licensed optometrist;
                  dd)       Other health care personnel providing direct  
                    patient care; or, 
                  ee)       Any other person performing non-diagnostic  








          AB 2179 (Gipson)                                   Page 3 of ?
          
          
                    testing.

          3)Establishes the Office of AIDS (OA) within DPH as the lead  
            agency within the state, responsible for coordinating state  
            programs, services, and activities relating to HIV/AIDS, and  
            AIDS-related conditions (ARC). 

          4)Requires DPH to authorize the establishment of training  
            programs throughout the state for counselors for publicly  
            funded HIV testing programs. 

          5)Permits a HIV counselor to perform a HIV, HCV, or combination  
            HIV/HCV test that is classified as waived under CLIA if the  
            following conditions exist:  

                  a)        The performance of the HIV, HCV, or  
                    combination HIV/HCV test meets the requirements of  
                    CLIA and the California clinical lab requirements.
                  b)        The HIV counselor meets one of the following  
                    criteria:

                     i.          Is trained by the OA and working in a HIV  
                      counseling and testing site funded by the DPH  
                      through a local health jurisdiction, or its agents;
                     ii.    Is working in a HIV counseling and testing  
                      site that utilizes HIV counseling staff who are  
                      trained by the OA or its agents; or, 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 DPH.

                  c)        The HIV, HCV, or combination HIV/HCV test is  
                    performed under the overall operation and  
                    administration of a lab director;  
                  d)        The patient is informed that the preliminary  
                    result of the test is indicative of the likelihood of  
                    HIV infection or HCV exposure and that the result must  
                    be confirmed by an additional more specific test, or,  
                    if approved by the federal Centers for Disease Control  
                    and Prevention (CDC) for that purpose, a second  
                    different rapid HIV, HCV, or combination HIV/HCV test;  
                    and, 
                  e)        If performing skin punctures for the purpose  








          AB 2179 (Gipson)                                   Page 4 of ?
          
          
                    of withdrawing blood for HIV, HCV, or combination  
                    HIV/HCV testing, the counselor must:

                        i.             Work under the direction of a  
                         licensed physician and surgeon;
                        ii.            Have specific authorization from a  
                         licensed physician and surgeon; and,
                        iii.           Be trained in both rapid HIV, HCV,  
                         or combination HIV/HCV test proficiency for skin  
                         puncture blood tests and oral swab tests and 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.
             6)   Permits a HIV counselor to order and report the results  
               from the HIV, HCV, or combination HIV/HCV test to a patient  
               without authorization from a licensed health care  
               professional or the patient's authorized representative. 

             7)   Requires patients with indeterminate or positive results  
               from the HIV, HCV, or combination HIV/HCV test be referred  
               to a licensed health care provider whose scope of practice  
               includes the authority to refer patients for laboratory  
               testing for further evaluation. 

             8)   Provides that a HIV counselor is not authorized to  
               perform any other test unless that person meets the  
               statutory and regulatory requirements for performing the  
               other test.
          
          This bill:
          1)Requires HCV counselors to meet one of the following criteria:

                  a)        Be trained by the OA and work in a HIV  
                    counseling and testing site funded by DPH through a  
                    LHJ, or its agents.
                  b)        Work in a HIV counseling and testing site  
                    that:
                  c)        Utilize HIV counseling staff who are trained  
                    by OA or its agents to provide both HIV counseling and  
                    testing and hepatitis C counseling and testing;
                  d)        Have and retain a quality assurance plan  
                    approved by the local health department (LHD) in the  
                    jurisdiction where the site is located and have HIV  








          AB 2179 (Gipson)                                   Page 5 of ?
          
          
                    counseling and testing staff who comply with the  
                    quality assurance requirements as specified by DPH;  
                    and,
                  e)        Work at a site approved by the LHD to provide  
                    HCV rapid testing and counseling, and has been trained  
                    using a curriculum approved by the LHD, and retained  
                    by the site, or approved by DPH, which, at a minimum,  
                    provides training in universal precautions, safe  
                    working conditions, proper running and reading of HCV  
                    rapid test kit technology, and providing accurate  
                    information to clients including the importance of  
                    confirmatory tests, linkages to medical care, and the  
                    prevention of HCV transmission.

          2)Permits HCV counselors who meet these requirements to:

                  a)        Perform any HCV test that is classified as  
                    waived under CLIA if:

                        i.             The performance of the HCV test  
                         meets the requirements of CLIA and state law.
                        ii.            In the case of performing skin  
                         punctures for the purpose of withdrawing blood  
                         for waived HCV testing, specific authorization  
                         from a licensed physician is obtained and the  
                         person:

                            1)                  Works under the direction  
                              of a licensed physician and surgeon.
                            2)                  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 CDC.
                        iii.           The person performing the HCV test  
                         meets the requirements for the performance of  
                         waived laboratory testing pursuant to existing  
                         state law 2) above.
                        iv.            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  








          AB 2179 (Gipson)                                   Page 6 of ?
          
          
                         specific test, or, if approved by the CDC for  
                         that purpose, a second, different rapid HCV test.  

                  b)        Order and report HCV test results from tests  
                    to patients without authorization from a licensed  
                    health care practitioner or his or her authorized  
                    representative. Requires a patient who has an  
                    indeterminate or positive test result to be referred  
                    to a licensed health care practitioner whose scope of  
                    practice includes the authority to refer a patient for  
                    laboratory testing for further evaluation.

          3)Prohibits a HIV counselor who meets the requirements of this  
            bill with respect to performing any CLIA-waived HCV from  
            performing any other test unless that person meets the  
            statutory and regulatory requirements for performing that  
            other test.

          4)Specifies that compliance with this bill does not fulfill any  
            requirements for certification as a phlebotomy technician or a  
            limited phlebotomy technician, unless the HCV counselor has  
            otherwise satisfied the certification requirements imposed  
            pursuant to existing state law.

           FISCAL  
          EFFECT  :  According to the Assembly Appropriations Committee,  
          uncertain, potential cost pressure to the DPH.  This bill does  
          not place direct requirements on the department, but is intended  
          to allow local health jurisdictions (LHJs) flexibility to  
          approve and implemented their own training programs.  However,  
          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.    

           PRIOR  
          VOTES  :  
          
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          |Assembly Floor:                     |80 - 0                      |
          |------------------------------------+----------------------------|
          |Assembly Appropriations Committee:  |20 - 0                      |
          |------------------------------------+----------------------------|
          |Assembly Business and Professions   |16 - 0                      |
          |Committee:                          |                            |








          AB 2179 (Gipson)                                   Page 7 of ?
          
          
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           COMMENTS  :
          1)Author's statement.  According to the author, the hepatitis C  
            virus (HCV) is a communicable disease that is spread by  
            blood-to-blood contact. If untreated, HCV can lead to liver  
            cancer, liver disease, cirrhosis, and death. Early detection  
            reduces the likelihood of disease progression, reduces costs  
            of treatment, and prevents new infections in the community. 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. AB 2179 would allow local health jurisdictions  
            (LHJs) as well as CDPH, 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 federal Clinical Laboratory Improvement  
            Amendments of 1988 (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.
            
            Background.  According to DPH, hepatitis C is a liver disease  
            caused by HCV and usually spread through blood. People can  
            become infected through sharing needles, needle-stick injuries  
            in health care settings, or being born to a mother who has  
            hepatitis C. Less commonly, a person can also get HCV  
            infection through sharing personal care items that may have  
            come in contact with another person's blood (like razors or  
            toothbrushes), or having sexual contact with a person infected  
            with the virus. Hepatitis C can be either "acute" or  
            "chronic," and can range in severity from a mild illness  
            lasting a few weeks to a lifelong illness. According to the  
            CDC, millions of Americans have hepatitis C, but most don't  
            know it, because people often have no symptoms and can live  
            with an infection for decades without SB 1303 | Page 3 feeling  
            sick. About 80 percent who have HCV infection develop a  
            chronic, or lifelong, infection. Hepatitis C is a leading  
            cause of liver cancer and the leading cause of liver  
            transplants. According to data from 1999 to 2008, about  
            three-fourths of U.S. patients with HCV infection were born  
            between 1945 and 1965. The most important risk factor for HCV  








          AB 2179 (Gipson)                                   Page 8 of ?
          
          
            infection is past or current IDU, with most studies reporting  
            a prevalence of 50 percent or more. The incidence of HCV  
            infection was more than 200,000 cases per year in the 1980s  
            but decreased to 25,000 cases per year by 2001. According to  
            the CDC, there were an estimated 16,000 new cases of HCV  
            infection in 2009 and an estimated 15,000 deaths in 2007. 

            USPSTF recommendations.  Released in June 2013, the USPSTF  
            recommendations for HCV infection screening apply to all  
            asymptomatic adults without known liver disease or functional  
            abnormalities. Persons born between 1945 and 1965 are more  
            likely to be diagnosed with HCV infection, possibly because  
            they received blood transfusions before the introduction of  
            screening in 1992 or have a history of other risk factors for  
            exposure decades earlier. The recommendations state that a  
            risk-based approach may miss detection of a substantial  
            proportion of HCV-infected persons in the birth cohort because  
            of a lack of patient disclosure or knowledge about prior risk  
            status. As a result, one-time screening for HCV infection in  
            the birth cohort may identify infected patients at earlier  
            stages of disease who could benefit from treatment before  
            developing complications from liver damage. 


            Federal and state lab requirements.  Under the federal CLIA  
            law, labs 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.
             
            As defined by CLIA, waived tests are simple tests with a low  
            risk for an incorrect result.  Waived tests include tests  
            listed in the CLIA regulations, tests cleared by the FDA for  
            home use, and tests approved for waiver by the FDA using the  
            CLIA criteria.  In order for the FDA to approve a test device  
            as waived, the manufacturer must show that the test is  
            accurate and consistent when performed by untrained  
            individuals.  This includes performing studies conducted using  
            participants without laboratory training, no prior experience  
            of the test, and no verbal instruction.  The study  
            participants must be able to generate accurate results using  
            only the product label and included instructions.








          AB 2179 (Gipson)                                   Page 9 of ?
          
          

            Because waived tests are essentially consumer-level products,  
            facilities that use only waived tests are eligible for a  
            certificate of waiver.  Those with a certificate of waiver are  
            not subject to the CLIA requirements as long as the tests are  
            performed according to the manufacturer's instructions.   
            However, CLIA still requires that all laboratories meet  
            individual state personnel license requirements. 
            Under California law, all laboratory tests classified under  
            CLIA must be performed by personnel specified in statute under  
            the overall operation and administration of a laboratory  
            director, with limited exceptions. As of 2014, California is  
            one of 15 other states that regulate laboratories in addition  
            to the CLIA standards.

            HIV and HCV counselors.  Existing law allows HIV counselors to  
            perform a HIV, HCV, and combination HIV/HCV test as long as it  
            is classified as waived under CLIA, the facility or clinic has  
            obtained a certificate of waiver from CMS and DPH approval,  
            and the HIV counselor has attended trainings specific to each  
            type of test.  Currently, the OA establishes or approves a  
            local health jurisdiction's (LHJ's) HIV Counseling and Testing  
            (C&T) 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 OA's Integrated HIV Surveillance, Prevention,  
            and Care Plan (Integrated Plan), budget cuts during fiscal  
            year 2009-10 reduced the OA's funding for many 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 C&T training as a part of the CDC's program, but  
            the remaining LHJs must pay for the C&T training out of their  
            own funds and spaces within the C&T trainings are limited.  

            The sponsor notes that having to pay out of pocket for the C&T  
            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  








          AB 2179 (Gipson)                                   Page 10 of ?
          
          
            cannot attend the HCV C&T training without attending the HIV  
            C&T 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 this issue in two ways: 1) authorizing a  
            LHJ to 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  
            program. 

            Double referral. This bill was heard in the Senate Business  
                                                                      and Professions Committee on June 21, 2016, and passed with a  
            9-0 vote.

            Previous legislation. AB 761(Roger HernŠndez, Chapter 714,  
            Statutes of 2012), provides that a laboratory director may  
            include a licensed optometrist and authorizes an optometrist  
            to perform certain clinical laboratory tests or examinations  
            classified as waived under CLIA.

            SB 1481(Negrete McLeod Chapter 874, Statutes of 2012), allows  
            pharmacists to perform specific CLIA waived tests without the  
            supervision of a laboratory director. 

            AB 1382 (Roger HernŠndez, Chapter 643, Statutes of 2011),  
            authorized HIV test counselors to perform HCV or combined  
            HIV/HCV tests in addition to HIV tests.

            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  
            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. 









          AB 2179 (Gipson)                                   Page 11 of ?
          
          

            Support.  Project Inform is the sponsor of this bill and  
            states current state law allows non-medical personnel to  
            administer HCV rapid tests in compliance with CLIA standards,  
            but only if personnel are working at a DPH-OA funded site, or  
            authorized by a LHJ; have been trained to administer an 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.  The sponsor notes this bill will  
            give local governments greater flexibility and reduce costs  
            related to training non-medical personnel to administer the  
            rapid test to screen for HCV in community settings by allowing  
            LHJs as well as DPH to certify training standards for HCV  
            rapid test counselors.



            Mendocino County AIDs/Viral Hepatitis Network (MCAVNH)  
            supports this bill stating that they are the only HIV/IDS/HCV  
            service-oriented, community based harm reduction organization  
            in all of Mendocino County.  MCAVNH notes that they have  
            adapted their services to assist those with multiple co-morbid  
            conditions, and within Mendocino County persons who inject  
            drugs have a projected HCV positive rate of 85%, and that  
            early detection reduces the likelihood of disease progression,  
            reduces costs of treatment, and prevents new infections in the  
            community.  MCAVNH concludes that 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.
            SUPPORT AND OPPOSITION  :
              Support:Project Inform (sponsor)
                    Access Support Network
                    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
                    C.O.R.E. Medical Clinic, Inc.
                    Desert AIDS Project
                    Drug Policy Alliance
                    Harm Reduction Coalition








          AB 2179 (Gipson)                                   Page 12 of ?
          
          
                    Health Officers Association of California
                    HIV Education and Prevention Project of Alameda County
                    Mendocino County AIDS/Viral Hepatitis Network
                    San Francisco Hepatitis C Task Force
                    S.T.O.P. Hepatitis Task Force
                    Wall Las Memorias Project
          
          Oppose:   None received

          
                                      -- END --