BILL ANALYSIS Ó SB 289 Page 1 Date of Hearing: July 3, 2012 ASSEMBLY COMMITTEE ON HEALTH William W. Monning, Chair SB 289 (Ed Hernandez) - As Amended: June 19, 2012 SENATE VOTE : Not relevant. SUBJECT : Clinical laboratory techniques: training and instruction. SUMMARY : Authorizes the Department of Public Health (DPH) to approve a clinical training site seeking to provide instruction in clinical laboratory techniques which in the judgment of DPH will provide adequate instruction to prepare individuals to meet the requirements for licensure or performance of duties, as specified. Specifically, this bill : 1)Revises which clinical training sites DPH is authorized to approve to provide instruction in clinical laboratory techniques 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, to include any of the following: a) A California licensed clinical laboratory; b) An accredited college or university in the United States of America (U.S.); c) A U.S. military medical laboratory specialist program of at least 52 weeks duration; and, d) A laboratory owned and operated by the U.S. government. 2)Exempts 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, techniques, theory, or other training, as specified. SB 289 Page 2 4)Revises and recasts existing definitions and makes other technical, non-substantive and clarifying changes. EXISTING LAW : 1)Establishes within DPH the Laboratory Field Services which provides for licensing and registration services for clinical laboratories and clinical laboratory licensees, as specified. 2)Authorizes DPH to approve schools seeking to provide instruction in clinical laboratory technique 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 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. Requires that applications for approval be made on forms provided by DPH. 3)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 first having secured the approval of the DPH. 4)Establishes in federal law, CLIA, which regulates laboratories when performing testing on human specimens, and includes laboratory standards for proficiency testing, facility administration, personnel qualifications, and quality control. Applies standards to all settings, including commercial, hospital, or physician office laboratories. FISCAL EFFECT : This bill, as currently amended, has not been analyzed by a fiscal committee. COMMENTS : 1)PURPOSE OF THIS BILL . According to the author, the California Hospital Association estimates that the lack of clinical laboratory scientists is one of the top vacancy problems in SB 289 Page 3 the State for non-nursing health care professions. A CLS is an integral part of health care delivery, conducting 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 U.S. Bureau of Labor and Statistics, between now and 2018 California is projected to have 510 CLS openings annually due to growth and job separations. Stakeholders argue that a key obstacle to increasing the supply of CLS in the State is the insufficient number and maldistribution of approved clinical training sites. 2)BACKGROUND . a) Approval of Clinical Laboratory Training Programs . DPH is granted the authority to approve schools seeking to provide instruction in clinical laboratory technique to meet 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 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 licensees: clinical laboratory technologist; clinical laboratory bioanalyst; physician and surgeon; or, appropriate laboratory specialty. The ratio of clinical laboratory personnel to trainees is no less than 2:1. Regulations also specify minimum requirements for approval of a laboratory to employ clinical laboratory technologist trainees, including: necessary equipment; workload requirements; and, 52 weeks of practical training in the areas of biochemistry, hematology, pretransfusion 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, conducting courses for the training of CLS also required to be approved by DPH. According to DPH, it has approved 92 CLS programs in California, over 100 phlebotomy training programs, and 10 medical laboratory technician programs. b) Shortage of CLS . According to the Center for the Health SB 289 Page 4 Professions report entitled "California's Health Care Workforce: Readiness for the ACA Era," California's employment of CLS has been stagnant since 2001, while national CLS employment has grown 15%. California's per capita supply of CLS is much lower than the nation's; 35 CLS per 100,000 population in California compared to 54.4 per 100,000 in the US overall. From 1980 to 2005, the number of CLS licensure candidates dropped from 2,515 to 724. The report also states that California's hospitals are concerned about the supply of clinical lab professionals, as vacancies in these areas have a significant impact on care delivery and hospital efficiency. According to a California Hospital Association (CHA) policy paper, current law that was adopted in the 1970s requires hospital laboratories to be individually approved by DPH to train CLS students for licensure. This approval is in addition to required federal certification under CLIA that ensures the accuracy and reliability of all laboratory testing. This state approval requirement, the paper points out prevents educational programs from using a training consortium that allows federally certified laboratories to come together to provide a portion of the required clinical training to students. This has limited CLS training program capacity because it prevents many smaller laboratories from participating in training. Smaller labs, especially in rural areas, may be inclined to train CLS students, but do not have the resources to take on the obligations of being an approved training entity. c) National Accrediting Agency for Clinical Laboratory Sciences . This bill specifies that a college or university that holds valid accreditation by NAACLS for clinical laboratory sciences will not be required to obtain separate approval for a clinical training site provided that the site has a certification under CLIA. According to its website, NAACLS accredits and approves education programs in clinical laboratory sciences and related health care professions. According to DPH, NAACLS standards are less rigorous than training required under existing regulations, including: i) CLS programs approved in California require one year SB 289 Page 5 of practical training. NAACLS does not specify the length of the program and currently some NAACLS CLS training programs are as short as 16 weeks; ii) CLS programs approved in California require a specified number of weeks in each major area of the clinical laboratory. NAACLS programs for CLS do not specify the period of time spent in each area of the clinical laboratory; iii) Current regulations specify a ratio of licensed personnel to trainee of 2:1. NAACLS does not have a specified ratio; iv) Existing regulations specify a minimum number of California licensed persons on duty in the laboratory. NAACLS does not specify that California licensed persons must be on duty in the laboratory; v) California regulations specify that the teaching staff must have qualifications considered equivalent to minimum for California licensure. NAACLS specifies that they possess nationally recognized certification. vi) NAACLS does not specify that the program director must be licensed in California by DPH, only that he or she possess a specific degree and hold nationally recognized certification (not defined) as a medical laboratory scientist/medical technologist. vii) Existing regulations specify that DPH approves the clinical training conducted in conjunction with a college program. This bill allows NAACLS to approve the clinical program. 3)SUPPORT . The California Hospital Association states that giving DPH the authority to approve CLS training programs that use the consortium model will allow multiple hospitals to work together to provide portions of clinical experience, thereby sharing the responsibility and significant costs of training. The Blood Centers of California believes that an expansion of the facilities approved as clinical training sites is critical. 4)OPPOSE UNLESS AMENDED . The California Association for Medical Laboratory Technology (NAML) states that DPH has rigorous SB 289 Page 6 standards that meet or exceed NAACLS and state approved programs should not be discriminated against if they are not NAACLS approved. NAML states that this bill should be amended to indicate that all state approved programs should be free to determine their CLS training sites. 5)RELATED LEGISLATION . AB 2214 (Monning), among other provisions, requires clinical laboratory licensees, as specified, to report practice status to DPH upon issuance and renewal of license. AB 2214 is pending in the Senate Appropriations Committee. 6)DOUBLE REFERRAL . This bill is double referred and is scheduled to be heard in the Assembly Business, Professions & Consumer Protection Committee on July 3, 2012. 7)AUTHOR'S AMENDMENTS . In an effort to address concerns raised by Committee staff and the opposition, the author has agreed to amend this bill to delete the provisions relating to NAACLS accreditation on page 8, lines 11 - 17. REGISTERED SUPPORT / OPPOSITION : Support Blood Centers of California California Hospital Association California Society of Pathologists Sharp HealthCare Oppose Unless Amended California Association for Medical Laboratory Technology Analysis Prepared by : Rosielyn Pulmano / HEALTH / (916) 319-2097