BILL ANALYSIS Ó SB 289 Page 1 Date of Hearing: July 3, 2012 ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER PROTECTION Mary Hayashi, Chair SB 289 (Hernandez) - As Amended: June 19, 2012 SENATE VOTE : 36-2 SUBJECT : Clinical laboratory techniques: training and instruction. SUMMARY : Allows the Department of Public Health (DPH) to approve additional providers of clinical laboratory instruction. Specifically, this bill : 1)Allows DPH to approve any of the following to provide instruction in clinical laboratory technic which in DPH's judgment will adequately prepare individuals to meet the requirements for licensure or performance of duties under laws and DPH regulations governing clinical laboratory technology: a) A California licensed clinical laboratory; b) An accredited United States (U.S.) college or university; c) A U.S. military medical laboratory specialist program of at least 52 weeks in duration; or, d) A laboratory owned and operated by the U.S. government. 2)Prohibits a college or university holding valid accreditation by the National Accrediting Agency for Clinical Laboratory Sciences (NAACLS) that meets the requirements of 1), above, from being required to obtain separate approval for a clinical training site, provided that the clinical training site has obtained certification under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA), as specified. 3)Defines a clinical training site as any place, establishment, or institution used by a DPH-approved program for the training of clinical laboratory scientists (CLS) or limited CLS to conduct training or instruction of licensed trainees or phlebotomy students in clinical laboratory practice, SB 289 Page 2 techniques, theory or other training, as specified. 4)Revises and recasts existing definitions and makes other technical, non-substantive and clarifying changes. EXISTING LAW : 1)Provides for the licensure and regulation of clinical laboratories and their personnel by DPH under the Laboratory Field Services (LFS). 2)Authorizes DPH to approve schools seeking to provide instruction in clinical laboratory technic which in the judgment of DPH will provide instruction adequate to prepare individuals to meet the requirements for licensure or performance of duties, as specified. Requires DPH to establish by regulation the ratio of licensed clinical scientists to licensed trainees on the staff of the laboratory approved as a school and the minimum requirements for training in any specialty or in the entire field of clinical laboratory science or practice. 3)Authorizes DPH to approve schools that are accredited by NAACLS. 4)Provides that it is unlawful for any person to operate a school or conduct any course for the purpose of training or preparing persons to perform duties, as specified, without approval by DPH. 5)Establishes educational and examination requirements for a number of clinical lab personnel, including CLS and limited CLS licensees and trainees and a variety of CLS sub-specialties. 6)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. FISCAL EFFECT : Unknown SB 289 Page 3 COMMENTS : Purpose of this bill . According to the author, "In order to be trained as a CLS in California, the LFS has interpreted its regulations for the past 40 years to mean that the 50-week CLS training program be undertaken at a single site, usually a hospital or a biotech lab. A CLS training program is costly for the host institution, running anywhere from $55,000 to $110,000 a year per student. Thus, running a CLS training program can be quite prohibitive for an institution to undertake. "SB 289 would broaden the definition of an approved training site, and allow an institution of higher education to be an approved training entity for a CLS training program. Please note that the students would not train at the institution of higher education; rather, (the bill) would allow the institution to act as the central administrator by coordinating the 50-week program among different hospitals/labs. "Schools (that) offer CLS programs include California State University (CSU), San Francisco, CSU San Jose, CSU Dominguez Hills, CSU, Los Angeles, University of California, Irvine, and University of Southern California. Under SB 289, the program coordinators at these schools would be able to work with various hospitals and labs in the region to build a consortium of sites willing to train students for varying periods of time. This would allow various hospitals/labs to share in the cost of the program while not compromising quality or content, resulting in more entities willing to be a CLS training site." Background . A CLS is an integral part of health care delivery and conducts a wide range of diagnostic assessments, from blood tests to genetic testing, in order to assist physicians in diagnosing illness and determining treatment plans. According to the author, current regulations, promulgated in the 1970s, require DPH-approved CLS training sites or entities to be a laboratory where the clinical experience takes place. This law has been interpreted by DPH to preclude an institution of higher learning from being an approved training entity. This has limited CLS training capacity in California because it prevents many smaller labs and hospitals (such as rural hospitals) from participating in training. The California Hospital Association estimates that the lack of SB 289 Page 4 CLS is one of the top vacancy problems in the state for non-nursing health care professions. According to the U.S. Bureau of Labor Statistics, between now and 2018, California is projected to have 510 CLS openings annually due to growth and job separations. This number is particularly sobering when compared to the annual number of CLS graduates in the state (approximately 110 - 130). California clinical laboratories are subject to both federal and state oversight. Federal oversight is stipulated in CLIA, which is administered by the Centers for Medicare and Medicaid Services within the U.S. Department of Health and Human Services. CLIA regulates clinical labs based on the complexity of tests the lab offers. "Waived" tests are approved by the Food and Drug Administration (FDA) for home use, use simple and accurate methods that make the possibility of error negligible, or pose no significant risk of harm to the patient if incorrectly performed. Clinical labs performing only "waived" tests must register with the CLIA program, pay biennial certificate fees, allow inspections, and perform tests according to manufacturers' instructions. "Moderate" or "high" tests, which are more complex, may be performed by clinical labs that pay higher fees, undergo biennial inspections, and meet tougher standards for personnel, supervision, quality assurance and proficiency testing. DPH regulates about 19,000 clinical labs and their personnel statewide, monitors proficiency testing, investigates complaints, and sanctions labs that violate the law or regulations. In accordance with CLIA, DPH licenses or registers clinical labs according to the complexity of testing 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. DPH has authority to approve schools seeking to provide instruction in clinical laboratory techniques to meet CLS licensure requirements. According to regulations, any person operating a school or conducting any course for CLS must comply with DPH's personnel, equipment, quality of instruction, and scope of activities requirements. A training school can only SB 289 Page 5 accept a person licensed for training in clinical laboratory procedures if there are on active duty in the laboratory a minimum of two full-time actively employed persons who possess any of the following licenses: clinical laboratory technologist; clinical laboratory bioanalyst; physician and surgeon; or, an appropriate laboratory specialty. The ratio of clinical laboratory personnel to trainees is no less than 2:1. Regulations also specify the minimum requirements necessary for approval of a laboratory to employ clinical laboratory technologist trainees, including: necessary equipment, as specified; workload requirements; and, 52 weeks of practical training, including biochemistry, hematology, pre-transfusion procedures, urinalysis, bacteriology, serology, and parasitology. Colleges or universities accredited by the Western College Association or the Northwest Association of Secondary and Higher Schools or an essentially equivalent accrediting agency, as determined by DPH, that conduct CLS training courses must be approved by DPH. However, when training is carried out in cooperation with laboratories other than those of the institution, specific approval must be obtained from DPH. Regulations also specify the timeframes for DPH to approve training programs and to process applications for renewals. This bill specifies that a college or university accredited by NAACLS for clinical laboratory sciences is not required to obtain separate approval for a clinical training site, if the site is certified under CLIA. According to its Web site, NAACLS accredits and approves education programs in clinical laboratory sciences and related health care professions, including those that offer a clinical doctorate in clinical laboratory science, medical laboratory scientist, medical laboratory technician, histotechnologist, histotechnician, diagnostic molecular scientist, cytogenetic technologist, and pathologists' assistant. NAACLS also independently approves phlebotomist and clinical assistant educational programs. NAACLS is recognized by the Council for Higher Education Accreditation. Support . The Blood Centers of California writes, "As health care providers, we have been affected by the shortage of various licensed health care providers in California. We have particularly been hard hit by the shortage of CLS over the last five or more years. CLS hired by blood centers have to meet a higher standard because of the high complexity and sophisticated SB 289 Page 6 testing required to assure the safety of the blood supply. We can only employ the generalist CLS with additional blood banking training and/or the CLS with a specialty (limited) license in immunohematology and hematology. It also should be noted (that) blood centers cannot employ a CLS trainee; all potential CLS blood laboratory candidates must have a current CLS license in good standing. "To that end, three of our hospital blood centers have established clinical training programs to 'grow our own' by collaborating with university programs and local government programs. We are gradually increasing the numbers of candidates that meet the strong state and national requirements for blood banking. We believe an expansion of the facilities approved as clinical training sites is critical." Opposition . The California Association for Medical Laboratory Technology states, "This bill fails to recognize the strength of the state certifying programs, and that all the CLS training programs in California accredited by LFS should benefit from the proposed streamlining. "LFS has rigorous standards that meet or exceed the NAACLS. LFS state approved programs should not be discriminated against if they are not NAACLS approved. Therefore, we believe the bill should be amended to state that all state approved programs should be free to determine their CLS training sites without the duplicate paperwork that is currently required. We agree that steps should be taken to address the clinical laboratory shortage and also concur that the current system for clinical laboratory training is too cumbersome and would benefit from streamlining, but in a manner that is equally fair to both NAACLS approved and non-approved colleges and universities. Further, clinical laboratory training must be in LFS approved California licensed labs, whether NAACLS approved or not. The choice of the clinical training site should be up to the state approved program." Related legislation . AB 2214 (Monning) of 2012 requires, among other provisions, the California Workforce Investment Board, until January 1, 2019, to establish a special committee known as the Health Workforce Development Council to help expand the state's health workforce in order to provide access to quality health care for all Californians. This bill is pending in Senate Health Committee. SB 289 Page 7 SB 1481 (Negrete McLeod) of 2012 exempts community pharmacies performing only specified waived tests from state law governing the licensure and regulation of clinical laboratories. This bill is pending in Assembly Health Committee. Previous legislation . AB 761 (Roger Hernández) of 2011 allows optometrists to independently perform waived clinical laboratory tests if the results can be used within the optometrist's scope of practice, as specified. This bill was held in Assembly Business, Professions and Consumer Protection Committee. AB 1328 (Pan) of 2011 allows DPH to issue a CLS license to an applicant who completes at least two years of full-time employment as a CLS at a CLIA certified laboratory, who possesses a baccalaureate or an equivalent or higher degree from an accredited institution, and who passes a national examination approved by DPH, subject to the payment of a licensing fee. This bill was held in Assembly Business, Professions and Consumer Protection Committee. 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 requires clinical laboratories that perform tests 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 expands the duties that unlicensed personnel are authorized to perform in a clinical laboratory and revises the levels of supervision required when unlicensed personnel perform them. This bill was held in Assembly Business and Professions Committee. AB 1370 (Matthews) of 2005 includes a pharmacist within the definition of laboratory director if the clinical laboratory test or examination is a routine patient assessment procedure, as defined. This bill was held in Assembly Business and SB 289 Page 8 Professions Committee. AB 433 (Nava) of 2005 exempts physician office laboratories from licensure and regulatory requirements governing clinical laboratories and their personnel by DPH. This bill was held in Assembly Health Committee. SB 1174 (Polanco), Chapter 640, Statutes of 2001, exempts certified emergency medical technicians and licensed paramedics providing life support who perform only CLIA-waived blood glucose tests from state law governing the licensure and regulation of clinical laboratories, as specified. Double referred . This bill is double-referred to Assembly Health Committee. REGISTERED SUPPORT / OPPOSITION : Support Blood Centers of California Opposition California Association for Medical Laboratory Technology Analysis Prepared by : Angela Mapp / B.,P. & C.P. / (916) 319-3301