BILL ANALYSIS Ó AB 2179 Page 1 ASSEMBLY THIRD READING AB 2179 (Gipson) As Amended April 14, 2016 Majority vote ------------------------------------------------------------------ |Committee |Votes|Ayes |Noes | | | | | | | | | | | | | | | | |----------------+-----+----------------------+--------------------| |Business & |16-0 |Salas, Brough, Baker, | | |Professions | |Bloom, Campos, | | | | |Chávez, Dahle, Dodd, | | | | |Burke, Gatto, Gomez, | | | | |Holden, Jones, | | | | |Mullin, Ting, Wood | | | | | | | |----------------+-----+----------------------+--------------------| |Health |19-0 |Wood, Maienschein, | | | | |Bonilla, Burke, | | | | |Campos, Chiu, | | | | |Dababneh, Gomez, | | | | | | | | | | | | | | |Roger Hernández, | | | | |Lackey, Nazarian, | | | | |Olsen, Patterson, | | | | |Ridley-Thomas, | | | | |Rodriguez, Santiago, | | | | |Steinorth, Thurmond, | | AB 2179 Page 2 | | |Waldron | | | | | | | |----------------+-----+----------------------+--------------------| |Appropriations |20-0 |Gonzalez, Bigelow, | | | | |Bloom, Bonilla, | | | | |Bonta, Calderon, | | | | |Chang, Daly, Eggman, | | | | |Gallagher, Eduardo | | | | |Garcia, Roger | | | | |Hernández, Holden, | | | | |Jones, Obernolte, | | | | |Quirk, Santiago, | | | | |Wagner, Weber, Wood | | | | | | | | | | | | ------------------------------------------------------------------ SUMMARY: Authorizes a hepatitis C counselor, who meets specified training requirements and works in specified testing sites, to perform hepatitis C virus (HCV) tests classified as waived under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA). Specifically, this bill: 1)Authorizes a hepatitis C counselor to perform a HCV test that is classified as waived under CLIA if the following conditions exist: a) The performance of the HCV test meets the requirements of CLIA and California's clinical laboratory requirements; b) The counselor meets one of the following training and workplace requirements: i) Is trained by the California Department of Public Health's (CDPH's) Office of Aids (OA) and is working in a HIV counseling and testing site funded by the CDPH through a local health jurisdiction (LHJ), or its agents; or, AB 2179 Page 3 ii)Is working in a HIV counseling and testing site that meets both of the following criteria: (1)Utilizes HIV counseling staff trained by the OA or its agents to provide both HIV counseling and testing and hepatitis C counseling and testing; and, (2)Has a quality assurance plan approved by the local health department in the jurisdiction where the site is located and has HIV counseling and testing staff who comply with the quality assurance requirements as specified by the CDPH; or, iii)Is working at a site approved by the local health department to provide hepatitis C rapid testing and counseling, and has been trained using a curriculum approved by the local health department or the CDPH, which, at a minimum, provides training in universal precautions, safe working conditions, proper running and reading of hepatitis C rapid test kit technology, and providing accurate information to clients including the importance of confirmatory tests, linkages to medical care, and the prevention of hepatitis C transmission; c) The HCV test is performed under the overall operation and administration of a laboratory director. Defines, for purposes of this requirement, an HIV counselor who meets the specified requirements as "other health care personnel providing direct patient care" under California's clinical laboratory requirements; d) The patient is informed that the preliminary result of the test is indicative of the likelihood of HCV exposure and that the result must be confirmed by an additional, more specific test, or, if approved by the Center for Disease Control and Prevention (CDC) for that purpose, a second, different rapid HCV test; and, e) If performing a skin punctures for the purpose of AB 2179 Page 4 withdrawing blood for HCV testing, the counselor must meet the following additional requirements: i) Work under the direction of a licensed physician and surgeon; ii)Obtain specific authorization from a licensed physician and surgeon; and, iii)Be trained in rapid test proficiency either for skin puncture blood tests or oral swab tests in universal infection control precautions, consistent with best infection control practices established by the Division of Occupational Safety and Health (DOSH) in the Department of Industrial Relations (DIR) and the CDC. 2)Authorizes the counselor to order and report the results from the HCV tests performed to a patient without authorization from a licensed health care practitioner or the patient's authorized representative. 3)Requires the counselor to refer a patient who has an indeterminate or positive test result to a licensed health care practitioner whose scope of practice includes the authority to refer a patient for laboratory testing for further evaluation. 4)Provides that a hepatitis C counselor is not authorized to perform any other test unless that person meets the statutory and regulatory requirements for performing the other test, including those requiring certifications in phlebotomy. FISCAL EFFECT: According to the Assembly Appropriations Committee, uncertain, potential cost pressure to the CDPH. This bill does not place direct requirements on the department, but is intended to allow local health jurisdictions (LHJs) AB 2179 Page 5 flexibility to approve and implemented their own training programs. However, CDPH indicates cost pressure in the hundreds of thousands of dollars to promulgate and implement regulations, provide technical assistance, and review, approve, and potentially implement Hepatitis C counselor trainings. 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 California reduce the costs and procedural barriers for training non-medical personnel to perform rapid HCV tests in order that local health departments can respond in a manner that is safe and appropriate to the urgency of the epidemic. [This bill] will give local health departments greater flexibility to respond to HCV in their communities and reduce costs related to training non-medical personnel to administer the rapid test." Background. Hepatitis means inflammation of the liver. Hepatitis C is an infection of the liver caused by HCV, one of several contagious viruses that can cause hepatitis. HCV is spread by blood-to-blood contact and common ways people become infected are through needle sharing, inadequate sterilization of medical equipment, and unscreened blood transfusions. The CDC estimates that there are 3.5 million people in the US have chronic HCV infection. Between 1994 and 2011, the CDPH had received 501,664 newly reported chronic HCV cases in California. As a result, the World Health Organization, the CDC, and the CDPH suggest policies that promote prevention and education among high-risk populations. This bill seeks to do so by authorizing HCV counselors to perform a HCV screening test if it is classified as waived under CLIA. The author states that doing so will increase access to HCV counselors, who will AB 2179 Page 6 promote prevention by providing screening and education services at a community level. Federal and State Laboratory Requirements. Under the federal CLIA law, laboratories that perform tests on human specimens must be certified by the Centers for Medicare and Medicaid Services (CMS). The requirements for CLIA certification vary depending on the complexity of the laboratory tests performed. The three complexities are waived, moderate, and high complexity. In general, the more complicated the test, the more stringent the requirements under CLIA. Waived tests are simple, consumer-level tests with a low risk for an incorrect result. However, California law only allows specified personnel to perform waived tests on others. HIV and HCV Counselors. Existing law allows HIV counselors to perform HIV, HCV, and combination HIV/HCV tests as long as the tests are classified as waived under CLIA, the facility or clinic has obtained a certificate of waiver from CMS and CDPH approval, and the HIV counselor has attended a Counseling and Testing (C&T) training specific to each type of test. Currently, the OA either establishes or approves federally-funded HIV C&T training programs for a LHJ's HIV counselors. However, not all LHJs are able to access the trainings. Access to the trainings is determined by incidence of HIV, but some LHJs have a high incidence of HCV but not a high incidence of HIV. The LHJs that cannot meet the HIV thresholds must pay for the trainings. The sponsor notes that having to pay out of pocket for the C&T training means that if the LHJ does not have the funds or the offered training is full, its counselors will not be able to provide necessary HCV testing and screenings. This bill seeks to remedy this issue in two ways: 1) authorizing a LHJ to AB 2179 Page 7 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. Analysis Prepared by: Vincent Chee / B. & P. / (916) 319-3301 FN: 0003188