BILL ANALYSIS Ó AB 2179 Page 1 Date of Hearing: March 29, 2016 ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS Rudy Salas, Chair AB 2179 (Gipson) - As Amended March 28, 2016 NOTE: This bill is double-referred, if passed by this Committee it will be referred to the Assembly Committee on Health. SUBJECT: Hepatitis C testing. 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). EXISTING FEDERAL LAW: 1)Requires that laboratories obtain a certificate, meet quality standards, and undergo inspections, among other things, before accepting materials derived from the human body. (CLIA, 42 USC §§ 263a - 263a-7) 2)Defines "laboratory" or "clinical laboratory" as a facility for the biological, microbiological, serological, chemical, immuno-hematological, hematological, biophysical, cytological, AB 2179 Page 2 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. (Title 42 United States Code (USC) § 263a(a)) 3)Exempts laboratories with a certificate of waiver from the CLIA, provided that the laboratory follows the manufacturer's instructions. (42 USC § 263a(d)(2)(C); Title 42 Code of Federal Regulations (CFR) § 493.15) 4)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. (42 USC § 263a(d)(3); 42 CFR § 493.15; 69 Federal Register (FR) 22849) 5)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. (45 USC § 263a(p)) EXISTING STATE LAW: 6)Provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by the California Department of Public Health (CDPH). (Business and Professions Code (BPC) §§ 1200-1327) AB 2179 Page 3 7)Defines "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(a)(5)) 8)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: (BPC § 1206.5) 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 CDPH. e) A licensed physician assistant. AB 2179 Page 4 f) A licensed nurse. g) A licensed vocational nurse. h) A certified perfusionist. 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. ee)Any other person performing nondiagnostic testing, as specified. 9)Establishes the Office of AIDS (OA) within the CDPH as the lead agency within the state, responsible for coordinating state programs, services, and activities relating to the human immunodeficiency virus (HIV), acquired immune deficiency syndrome (AIDS), and AIDS related conditions (ARC). (Health and Safety Code (HSC) § 131019) AB 2179 Page 5 10)Defines "human immunodeficiency virus" or "HIV" as the etiologic virus of AIDS. (HSC § 120775(b)) 11)Defines "HIV test" as any clinical test, laboratory or otherwise, used to identify HIV, a component of HIV, or antibodies or antigens to HIV. (HSC § 120775(c)) 12)Requires the CDPH to authorize the establishment of training programs throughout the state for counselors for publicly funded HIV testing programs. (HSC § 120871) 13)Authorizes 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: (HSC § 120917) a) The performance of the HIV, HCV, or combination HIV/HCV test meets the requirements of CLIA and the California clinical laboratory requirements (BPC §§ 1200 - 1327). 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 CDPH 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. (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 (Title 17 California Code of AB 2179 Page 6 Regulations (CCR) §1230). 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 (BPC § 1206.5). 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 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. AB 2179 Page 7 14)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. (HSC § 120917(a)(2)) 15)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. (HSC § 120917(a)(2)) 16)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: 17)Authorizes a hepatitis C counselor to perform a HCV test that is classified as waived under CLIA if the following conditions exist: a) The performance of the HCV test meets the requirements of CLIA and the California clinical laboratory requirements (BPC § 1200 - 1327). b) The counselor meets one of the following training and workplace requirements: i) Is trained by the OA and is working in a HIV counseling and testing site funded by the CDPH 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: AB 2179 Page 8 (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. (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 (17 CCR §1230). 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, a HIV counselor who meets the specified requirements as "other health care personnel providing direct patient care" under the California clinical laboratory requirements (BPC § 1206.5). 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 CDC for that purpose, a second, different rapid HCV test. e) If performing a skin punctures for the purpose of withdrawing blood for HCV testing, the counselor must meet the following additional requirements: AB 2179 Page 9 i) Work under the direction of a licensed physician and surgeon. ii)Obtain specific authorization from a licensed physician and surgeon. 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 DOSH in the DIR and the CDC. 18)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. 19)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. 20)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. FISCAL EFFECT: Unknown. This bill is keyed fiscal by the Legislative Counsel. COMMENTS: 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 AB 2179 Page 10 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 is a condition characterized by inflammation of the liver (CDC Hepatitis C Fact Sheet, 2015). Hepatitis C is an infection of the liver caused by HCV, one of several 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. Acute infections (short-term) are treatable with antiviral medications. However, the World Health Organization (WHO) notes that early detection can be difficult, medications can be costly, and there is currently no vaccine (WHO Hepatitis C Fact Sheet, 2015). Acute infections left untreated become chronic, and can result in liver disease, liver failure, and liver cancer. 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 (CDPH Chronic Hepatitis B and Hepatitis C Infections in California: Cases Newly Reported through 2011, November 2013). As a result, the WHO, 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 AB 2179 Page 11 increase access to HCV counselors, who will 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. 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. 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 AB 2179 Page 12 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 CDPH approval, and the HIV counselor has attended trainings specific to each type of test. Currently, the OA establishes or approves a 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 local health jurisdictions (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 (CDC PS12-1201 Comprehensive HIV Prevention Programs for Health Departments). 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. AB 2179 Page 13 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. Existing HCV Counselor Training Programs. Because counselors (and others) are prohibited from performing a HCV test classified as waived under CLIA, there is no existing standalone training program or provider. However, there is currently only one CLIA-waived HCV test, the OraQuick HCV Rapid Antibody Test. The OraQuick HCV Rapid test is manufactured by OraSure Technologies Inc. and is a qualitative immunoassay to detect antibodies to HCV in fingerstick whole blood and venipuncture whole blood specimens (see CLIA Currently Waived Analytes database under Hepatitis C, FDA premarket approval number (PMA) P080027). OraSure has stated that it is able to provide technical training and assistance in the use of its products, which include: 1)Dedicated account managers responsible for the Public Health and Hospital markets in California. 2)Live and webinar product training. 3)Quality Assurance Program development/support. 4)Technical assistance with test implementation. AB 2179 Page 14 5)Troubleshooting on product complaints in the field. 6)Marketing and PR support for special event days. 7)Free promotional support for organizations in the form of "palm cards." In addition to the technical device and fingerstick and venipuncture procedural trainings, non-CPA LHJs will also need to develop the public health and community health modules that are specific to HCV. The sponsor has stated that the process would be the same as when the HCV-specific module was developed for the OA's HIV training. Prior Related Legislation. AB 1382 (Roger Hernández), 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, as specified, 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 2179 Page 15 AB 1263 (Migden), Chapter 324, Statutes of 2001, among other things, authorized HIV counselors to perform HIV tests classified as waived under CLIA , as specified. AMENDMENT(S): The author should make the following technical amendments: 1)Page 2, line 2, strike "
A" and after "(a)" insert: Notwithstanding any other law, a 2)Page 2, line 8, strike " and, subject to subparagraph (B)," and insert: and 3)Page 2, line 17, strike: both4)Page 2, line 18, strike: and oral swab tests5)Page 3, lines 18-19, strike: This section does not certify a hepatitis C counselor as a phlebotomy technician or a limited phlebotomy technician.REGISTERED SUPPORT: Project Inform (sponsor) AB 2179 Page 16 Aids Community Research Consortium Asian Pacific Health Foundation California Hepatitis Alliance HIV Education and Prevention Project of Alameda REGISTERED OPPOSITION: None on file. Analysis Prepared by:Vincent Chee / B. & P. / (916) 319-3301