BILL ANALYSIS                                                                                                                                                                                                    ”



                                                                    AB 2179


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          Date of Hearing:  April 12, 2016


                            ASSEMBLY COMMITTEE ON HEALTH


                                   Jim Wood, Chair


          AB 2179  
          (Gipson) - As Amended March 30, 2016


          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 (CLIA).  Specifically, this bill:  


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


             a)   To be trained by the Office of AIDS (OA) and working in  
               an human immunodeficiency virus (HIV) counseling and  
               testing site funded by the Department of Public Health  
               (DPH) through a local health jurisdiction, or its agents;
             b)   To be working in an HIV counseling and testing site that  
               meets both of the following criteria:


               i)     Utilizes HIV counselling staff that is trained by  
                 the OA or its agent to provide both HIV counseling and  
                 testing and hepatitis C counseling and testing; and,
               ii)    Has a quality assurance plan approved by the local  
                 health department in the jurisdiction where the site is  








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                 located and has HIV counseling and testing staff who  
                 comply with the quality assurance requirements as  
                 specified by DPH; or,


             c)   To be 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 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.


          2)Authorizes a hepatitis C counselor who meets the criteria in  
            1) above 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 CLIA and state law.
               ii)    Perform skin punctures for the purpose of  
                 withdrawing blood for HCV testing upon authorization from  
                 a licensed physician provided that the person meets both  
                 of the following requirements:


                  (1)       He or she works under the direction of a  
                    licensed physician; and,
                  (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  








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                    Centers for Disease Control and Prevention (CDC).


               iii)   The person performing the HCV tests meet the  
                 requirements for the performance of waived laboratory  
                 testing pursuant to existing state law as described in  
                 existing law in 2) below.  For purposes of these  
                 provisions a hepatitis C counsel is "other health care  
                 personnel provide direct patient care," per existing law.
               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 specific test, or, if approved by the  
                 CDC, a second, different rapid HCV test.


             b)   Order and report HCV test results 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 revaluations.


          3)Prohibits a hepatitis C counselor as defined in these  
            provisions from performing any other test unless they meet the  
            statutory and regulatory requirements for performing that  
            other test.


          4)Specifies that compliance with these provisions does not  
            fulfill any requirements for certification as a phlebotomy  
            technician or a limited phlebotomy technician.


          EXISTING FEDERAL LAW:










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          1)Defines "laboratory" or "clinical laboratory" 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 that laboratories 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 CLIA,  
            provided that the laboratory follows the manufacturer's  
            instructions. 


          3)Provides that a laboratory is eligible for a certificate of  
            waiver if the laboratory 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, 
             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:


          5)Provides for the licensure, registration, and regulation of  
            clinical laboratories and various clinical laboratory  
            personnel by DPH.










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          6)Prohibits a person from performing a clinical laboratory test  
            or examination classified as waived under CLIA unless the  
            clinical laboratory test or examination is performed under the  
            overall operation and administration of the laboratory  
            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 testing.


          7)Establishes the OA within DPH as the lead agency within the  
            state, responsible for coordinating state programs, services,  
            and activities relating to HIV, acquired immune deficiency  
            syndrome (AIDS), and AIDS related conditions (ARC). 
          8)Requires DPH to authorize the establishment of training  
            programs throughout the state for counselors for publicly  








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            funded HIV testing programs. 


          9)Authorizes an 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 laboratory 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  
                 meets both of the following criteria:
                  (1)Utilizes HIV counseling staff who are trained by the  
                    OA or its agents; or,
                  (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 DPH.
             c)   The HIV, HCV, or combination HIV/HCV test is performed  
               under the overall operation and administration of a  
               laboratory director.  Defines, for purposes of this  
               requirement, a HIV counselor who meets the specified  
               requirements as "other health care personnel providing  
               direct patient care" under the California clinical  
               laboratory requirements.
             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. 
             e)   If performing skin punctures for the purpose of  








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               withdrawing blood for HIV, HCV, or combination HIV/HCV  
               testing, the counselor must meet the following additional  
               requirements:
               i)     The counselor works under the direction of a  
                 licensed physician and surgeon.
               ii)The counselor has specific authorization from a licensed  
                 physician and surgeon.
               iii)The counselor has been 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.


          10)Authorizes the 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. 
          11)Requires that 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. 


          12)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.


          FISCAL EFFECT:  This bill has not been analyzed by a fiscal  
            committee.


          COMMENTS:  










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          1)PURPOSE OF THIS BILL.  According to the author, the unchecked  
            spread of HCV threatens the public health and economic welfare  
            of California. The author states that there are an estimated  
            750,000 Californians living with HCV, and most do not know it,  
            and between 2002 and 2011 there were over 400,000 hepatitis B  
            and HCV-related hospitalizations in California, costing $26  
            billion.  The author contends that the burden of HCV is  
            expected to grow, and early detection reduces the likelihood  
            of disease progression, reduces treatment costs, and prevents  
            new infections.  The author also states that community-based  
            programs are best positioned to serve low-income communities,  
            including the homeless, reaching those who are currently not  
            enrolled in Medi-Cal or other health insurance, or who are  
            disconnected from primary care services.  The author asserts  
            that it is necessary for 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.  The author states that 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.  The author concludes that the current statutory  
            requirement that a person must complete training in HIV test  
            counseling before receiving HCV test counseling, and that the  
            training must be approved by a state health official rather  
            than a county health official is outdated and a barrier to  
            cost-effective disease control and prevention.  



          2)BACKGROUND.  


             a)   HCV.  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 the HCV, which is spread  
               primarily through contact with the blood of an infected  








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               person. Hepatitis C can be either "acute" or "chronic."   
               Acute HCV infection is a short-term illness that occurs  
               within the first six months after someone is exposed to the  
               HCV.  For most people, acute infection leads to chronic  
               infection.  Chronic Hepatitis C virus infection is a  
               long-term illness that occurs when HCV remains in a  
               person's body. HCV infection can last a lifetime and lead  
               to serious liver problems, including cirrhosis (scarring of  
               the liver) or liver cancer.  According to the CDC, most  
               people become infected with HCV by sharing needles or other  
               equipment to inject drugs.

             The CDC estimates that there are 3.5 million people in the  
               U.S. who have chronic HCV infection. Between 1994 and 2011,  
               DPH had received 501,664 newly reported chronic HCV cases  
               in California.  As a result, the World Health Organization,  
               the CDC, and DPH 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 promote prevention by providing  
               screening and education services at a community level.



             b)   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.
                


               As defined by CLIA, waived tests are simple tests with a  








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               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.





               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.











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             c)   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  








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               incidence of HCV.  Currently, the counselors working in  
               LHJs outside of the CPA 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. 





          3)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  








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            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.
          4)PREVIOUS LEGISLATION.  


             a)   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.

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



             c)   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.



             d)   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.










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             e)   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. 



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


          5)DOUBLE REFERRAL.  This bill has been double referred.  It  
            passed the Assembly Committee on Business and Professions with  
            a vote of 16-0 on March 29, 2016.


          6)TECHNICAL AMENDMENTS.  This bill is attempting to improve  
            access to training for persons who are providing HCV screening  
            by creating HCV tester training programs at the local level,  
            similar to the HIV training program provided at the state  
            level.  In order to more closely align the training and  
            supervision requirements for persons performing HPV tests with  
            those for persons performing HIV tests, the bill should be  
            amended as follows:


             a)   Clarify that skin punctures are only allowed to be  
               performed for waived tests;


             b)   Require local testing sites to maintain copies of LHJ  
               approved training documents; and, 


             c)   Add language to the Business & Professions code to  








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               clarify that waived HCV tests do not have to be performed  
               in a clinical laboratory.


          7)POLICY COMMENT.  Given that DPH has extensive experience in  
            providing and approving training programs, as this bill moves  
            forward, the author should consider adding in language that  
            would require DPH and LHJs to consult on developing the HCV  
            training programs. 
          REGISTERED SUPPORT / OPPOSITION:




          Support



          Project Inform (sponsor)
          C.O.R.E. Medical Clinic, Inc.
          Desert AIDS Project
          Harm Reduction Coalition
          Mendocino County AIDs/Viral Hepatitis Network
          San Francisco Hepatitis C Task Force
          STOP Hepatitis Task-Force
          The Wall Las Memorias Project
          One individual
          Opposition



          None on file.


          Analysis Prepared by:Lara Flynn / HEALTH / (916) 319-2097












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