BILL ANALYSIS Ó AB 1215 Page 1 Date of Hearing: April 16, 2013 ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER PROTECTION Richard S. Gordon, Chair AB 1215 (Hagman and Holden) - As Amended: April 9, 2013 SUBJECT : Clinical laboratories. SUMMARY : Redefines the term "laboratory director" to allow a licensed clinical laboratory scientist (CLS) to operate as the director of a clinical laboratory when performing simple tests exempted from the federal Clinical Laboratory Improvements Amendments (CLIA) of 1988. EXISTING STATE LAW : 1)Provides for the licensure and regulation of clinical laboratories and their personnel by the California Department of Public Health, and requires clinical laboratories to be operated under the supervision of a laboratory director, as specified. (Business and Professions Code [BPC] Section 1260 et seq.; California Code of Regulations, Title 17, Division 1, Chapter 2) 2)Prohibits the performance of a clinical laboratory test or examination classified as waived under the federal CLIA of 1988 unless the test or examination is performed under the overall operation and administration of a laboratory director, as defined, and is performed by specified persons, including certain health care personnel. (BPC 1209) 3)Defines the following terms: a) "Clinical laboratory scientist" shall mean any person other than a licensed clinical laboratory bioanalyst or trainee who is licensed to engage in clinical laboratory practice under the supervision of a laboratory director. A licensed CLS may perform clinical laboratory tests or examinations classified as of high complexity under CLIA and the duties and responsibilities of a technical consultant, clinical consultant, technical supervisor, and general supervisor, as specified under CLIA, in the specialties of histocompatibility, microbiology, diagnostic immunology, chemistry, hematology, immunohematology, AB 1215 Page 2 genetics, or other specialty or subspecialty specified by regulation adopted by the department. A licensed CLS may perform any clinical laboratory test or examination classified as waived or of moderate complexity under CLIA; (BPC 1204) and, b) "Laboratory director" shall mean any person who is a duly licensed physician and surgeon, or, only for purposes of a clinical laboratory test or examination classified as waived, is a duly licensed naturopathic doctor, or is licensed to direct a clinical laboratory and who substantially meets the laboratory director qualifications under CLIA for the type and complexity of tests being offered by the laboratory. (BPC 1209) EXISTING FEDERAL LAW : 1)Establishes CLIA under federal law, which regulates clinical laboratories that perform tests on human specimens and sets standards for facility administration, personnel qualifications and quality control. These standards apply to all settings, including commercial, hospital or physician office laboratories. (Title 42 of the Code of Federal Regulations [CFR], Part 493) 2)Defines CLIA waived tests as simple laboratory examinations and procedures that are approved by the Food and Drug Administration (FDA) for home use, employ methodologies that are simple and accurate as to render the likelihood of erroneous results negligible, or pose no reasonable risk of harm to the patient if the test is performed incorrectly. (42 CFR 493) FISCAL EFFECT : None. This bill is keyed non-fiscal by the Legislative Counsel. COMMENTS : 1)Purpose of this bill . This bill would allow CLSs to operate as laboratory directors overseeing clinical laboratories performing less complex CLIA-waived tests, thereby expanding the pool of individuals qualified to fill such positions. As federal law already authorizes CLSs to become laboratory directors but California does not, AB 1215 would conform state law to federal law. This bill is sponsored by the California AB 1215 Page 3 Association of Medical Laboratory Technology and multiple labor organizations. 2)Author's statement . According to the author's office, "Current law prohibits the performance of a clinical laboratory test or examination classified as waived by the CLIA, unless the test or examination is performed under the overall operation and administration of a laboratory director. Securing a laboratory director in California is a complex and expensive task that precludes other healthcare providers from being able to provide waived testing services to their patients. In recent years, bills have passed expanding who can be a laboratory director, but the most highly trained people, who actually work in the laboratories, cannot." 3)Clinical laboratory oversight . California clinical laboratories are subject to both federal and state oversight. The federal CLIA regulates clinical labs based on the complexity (low, moderate or high) of the tests offered. Congress passed CLIA in 1988, which established quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed. State oversight of clinical labs is administered by the California Department of Public Health's (DPH's) Laboratory Field Services (LFS), which regulates about 19,000 clinical labs and their personnel statewide, monitors proficiency testing, investigates complaints, and sanctions labs that violate the law or regulations. LFS provides licensing, registration, and certification services for clinical laboratory facilities, blood banks, tissue banks and the testing personnel who perform professional pre-analytical, analytical, and post analytical testing services for these facilities. In conformity with CLIA, DPH licenses or registers clinical labs according to the complexity of the tests they perform. Labs must be licensed for moderately or highly complex procedures, and registered for low complexity. About 3,000 clinical labs are licensed for moderate and/or high complexity testing. The remaining are registered labs performing waived tests and/or provider-performed microscopy. This bill deals specifically with tests that are 'waived', or AB 1215 Page 4 exempt from regulatory oversight, because they are approved by the FDA for home use, utilize simple and accurate methods that make the possibility of error negligible, or pose no significant risk of harm to the patient if incorrectly performed. Any person can purchase these tests from pharmacies, drugstores, supermarkets, or retail stores and conveniently perform the test at home. Examples of these tests include: dipstick or tablet reagent urinalysis, stool sampling, ovulation tests, urine pregnancy tests, and certain tests of a small amount of blood obtained by skin prick or blood draw. 4)Clinical laboratory director requirements and duties . A laboratory director must be a licensed physician and surgeon or meet other licensure requirements, and is responsible for overseeing the overall operation and administration of the laboratory. Under federal CLIA, CLSs can be waived laboratory directors. Under state law, for the purposes of waived tests, a laboratory director can also include a licensed naturopathic doctor, an optometrist or a person licensed to direct a clinical laboratory and who substantially meets the laboratory director qualifications under CLIA for the type and complexity of tests being offered by the laboratory. In recent years, state legislation has expanded the definition of who can become a lab director for waived labs (naturopaths, optometrists, and pharmacists), and this bill would add a CLS to that list. A laboratory director of a clinical laboratory performing waived tests is responsible for the overall operation and administration of the waived laboratory, including: ensuring that testing personnel are competent to perform test procedures; recording and reporting test results promptly, accurately, and proficiently; and assuring compliance with the applicable regulations relating to the state laboratory law and the federal CLIA. While the laboratory director may delegate such duties to persons who meet appropriate qualifications, the laboratory director is responsible for ensuring that all assigned duties and testing are properly performed. The lab director would also be accessible to the laboratory to provide onsite, telephone, or electronic consultation as needed. 5)Clinical Laboratory Scientist . A CLS holds, at the minimum, a bachelors of science degree with specific coursework in AB 1215 Page 5 laboratory disciplines such as hematology, medical microbiology, clinical chemistry, immunology, immunohematology, statistics, mathematics, quality assurance, instrumentation, and/or laboratory administration. In addition, CLSs must complete 52 weeks of clinical laboratory training in a DPH-approved laboratory and pass an approved licensure examination. A CLS may perform all three levels of CLIA tests - waived, moderate, and high complexity testing, including analyzing body fluids, cells, and tissue samples. Some of a CLS's duties include supervising unlicensed staff, phlebotomists, and medical laboratory technicians, managing daily activities and directing quality assurance, finances, and technological improvements in the laboratory. 6)Effects of this bill . By including CLSs in the definition of a "laboratory director," this bill would effectively allow CLSs to independently perform waived tests without supervision by another lab director. This would also allow a CLS who wishes to work part-time to operate a clinical laboratory performing CLIA-waived tests. CLSs are already licensed to perform the highest category of tests and are specifically trained in laboratory science and can ensure that tests are being performed properly and specimen procurement and handling are in accordance with protocols. Therefore, CLSs are presumably capable of performing the duties of a waived laboratory director, and may allow healthcare providers to hire CLSs more affordably than a physician or surgeon. 7)Arguments in Support . According to the lead sponsor, the California Association for Medical Laboratory Technology, "This bill permits licensed CLSs to serve as laboratory directors for waived laboratories, ensuring that the very individuals educated to do so function at the level of their training and license. "Federal law requires a clinical laboratory test to be performed under the overall supervision of a laboratory director. Federal law also allows CLSs to be directors of a waived laboratory. However, California law permits only physicians, surgeons, naturopaths, and to a more limited extent, optometrists and pharmacists, to be a director of a waived laboratory. It seems appropriate and in the public interest [that] the very profession training in clinical AB 1215 Page 6 laboratory science should service in this capacity [as a director of a waived laboratory] in California." 8)Related Legislation . AB 399 (Fox) of 2013 would authorize the DPH to establish application and license renewal fees for new license categories that exceed the costs for implementation. This bill is pending in the Assembly Business, Professions and Consumer Protection Committee. AB 830 (Holden) of 2013 would require DPH to promulgate regulations by January 1, 2015, requiring any facility operating a clinical laboratory to provide specified training to CLSs, medical laboratory technicians, and any individuals who are charged with direct and responsible supervision of either a CLS or a medical laboratory technician This bill is pending in Assembly Business, Professions and Consumer Protection Committee. 9)Previous Legislation . AB 761 (Hernández), Chapter 714, Statutes of 2012, allows optometrists to independently perform waived clinical laboratory tests necessary for the diagnosis of conditions and diseases of the eye. SB 1246 (Negrete McLeod), Chapter 523, Statutes of 2010, includes naturopathic doctors in the list of health care practitioners who can perform a clinical laboratory test or examination classified as waived under CLIA, and designates naturopathic doctors as clinical laboratory directors for CLIA-waived tests only. AB 1442 (Feuer) of 2007 would have required clinical laboratories that perform tests to screen for human immunodeficiency virus that are classified as waived under CLIA to enroll in a proficiency testing program and to obtain the appropriate license or registration from DPH, as specified. This bill was held on the Assembly Floor. AB 185 (Dymally) of 2007 would have expanded the duties that unlicensed personnel are authorized to perform in a clinical laboratory and would have revised the level of supervision required when unlicensed personnel perform them. AB 185 was held in Assembly Business and Professions Committee. AB 1370 (Matthews) of 2005 would have included a pharmacist within the definition of laboratory director if the clinical AB 1215 Page 7 laboratory test or examination is a routine patient assessment procedure, as defined. AB 1370 was held in Assembly Business and Professions Committee. AB 433 (Nava) of 2005 would have exempted physician office laboratories from licensure and regulatory requirements governing clinical laboratories and their personnel by the Department of Health Services. AB 433 was held in Assembly Health Committee. 10)Double-referral . This bill is double-referred, and if passed by this committee will be referred to the Assembly Health Committee. REGISTERED SUPPORT / OPPOSITION : Support California Association of Medical Laboratory Technology (sponsor) Engineers and Scientists of California, Local 20 of the International Federation of Professional and Technical Engineers (sponsor) United Nurses Associations of California/Union of Health Care Professionals (sponsor) Western States Council of the United Food & Commercial Workers (sponsor) Blood Centers of California California Society of Pathologists Opposition None on file. Analysis Prepared by : Joanna Gin / B.,P. & C.P. / (916) 319-3301