BILL ANALYSIS Ó ----------------------------------------------------------------- |SENATE RULES COMMITTEE | AB 757| |Office of Senate Floor Analyses | | |(916) 651-1520 Fax: (916) | | |327-4478 | | ----------------------------------------------------------------- THIRD READING Bill No: AB 757 Author: Gomez (D) Amended: 6/22/15 in Senate Vote: 21 SENATE BUS, PROF. & ECON. DEV. COMMITTEE: 8-0, 6/29/15 AYES: Hill, Bates, Block, Galgiani, Hernandez, Jackson, Mendoza, Wieckowski NO VOTE RECORDED: Berryhill SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8 ASSEMBLY FLOOR: 74-0, 5/22/15 (Consent) - See last page for vote SUBJECT: Healing arts: clinical laboratories SOURCE: Grifols, Inc. DIGEST: This bill makes an exception to California law to allow an individual who meets standards equivalent to federally requirements to perform a particular type of total protein refractometer test (TPRT) in a licensed plasma collection facility. ANALYSIS: Existing federal law: 1)Establishes conditions that laboratories must meet for certification to perform testing on human specimens under CLIA. (Title 42, Code of Federal Regulations (CFR) § 493.1) AB 757 Page 2 2)Classifies laboratory tests using three categories: "waived," "moderate complexity," or "high complexity." (42 CFR § 493.5) 3)Requires an individual performing moderate complexity testing to have a current license issued by the state in which the laboratory is located, if such licensing is required; and meets one of the following requirements: a) Is a physician or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution. b) Has earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution. c) Is a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist. d) Has earned a high school diploma or equivalent and documentation of training appropriate for the testing performed prior to analyzing patient specimens. (42 CFR § 493.1423) Existing state law: 1)Authorizes the following individuals to perform clinical laboratory tests or examinations classified as of moderate complexity under the Clinical Laboratory Improvement Amendments (CLIA) under the overall operation and administration of the laboratory director: a) A licensed physician and surgeon. b) A licensed podiatrist or a licensed dentist if the results of the tests can be lawfully utilized within his or her practice. c) A person licensed to engage in clinical laboratory AB 757 Page 3 practice or to direct a clinical laboratory. d) A licensed physician assistant if authorized by a supervising physician and surgeon. e) A licensed nurse. f) A perfusionist. g) A respiratory care practitioner. h) A person performing nuclear medicine technology. i) A person certified or licensed as an "Emergency Medical Technician II" or paramedic, a person licensed as a psychiatric technician, as a vocational nurse, or as a midwife, or certified as a nurse assistant or a home health aide, as specified. j) Any other person within a physician office laboratory if the test is performed under the supervision of the patient's physician and surgeon or podiatrist who shall be accessible to the laboratory to provide onsite, telephone, or electronic consultation as needed. aa) A pharmacist. (Business and Professions Code § 1206.5) This bill: 1)States the intent of the Legislature to enact legislation to identify who, and under which circumstances, may perform a TPRT test using an automatic, button-operated refractometer with a digital readout in a licensed plasma collection facility in California. 2)Authorizes a person who meets standards equivalent to the federal CLIA regulations for performing a moderate complexity test to perform a TPRT using an automatic, button-operated refractometer with a digital readout in a licensed plasma collection facility in California if all of the following conditions are met: a) He or she has earned a high school diploma or equivalent, as determined by the Centers for Medicare and AB 757 Page 4 Medicaid Services pursuant to CLIA. b) He or she performs the TPRT using an automatic, button-operated refractometer with a digital readout in a licensed plasma collection facility. c) His or her training in the proper procedure to be employed when performing a TPRT using an automatic, button-operated refractometer with a digital readout has been certified by a physician and surgeon licensed in this state or by a licensed clinical laboratory director who is in charge of the licensed plasma collection facility, or their certified, trained designate. The instructor shall document, and the plasma collection facility shall maintain the documentation of the individual's successful completion of training in the performance of the total protein refractometer test using an automatic, button-operated refractometer with a digital readout. d) He or she performs the TPRT using an automatic, button-operated refractometer with a digital readout under the direction and supervision of the physician and surgeon or licensed clinical laboratory director. e) He or she submits the test results to the physician and surgeon or licensed clinical laboratory director under whose direction and supervision he or she performed the test using an automatic, button-operated refractometer with a digital readout. 3)Sunsets the provisions of this bill on January 1, 2019. Background CLIA and California Law. The federal CLIA laws set the regulatory floor for laboratory testing; states are free to develop higher standards, and laboratories must follow whichever law is more stringent. According to the sponsor, California is one of 7 states that have developed more rigorous lab personnel requirements. California defers to CLIA in matters of determining test complexity, which dictates who and under what circumstances, may perform a test. The FDA categorizes diagnostic tests by their complexity-from AB 757 Page 5 the least to the most complex: waived tests, moderate complexity tests, and high complexity tests. Personnel authorized to perform the tests are required to have skill and training commensurate with the test level. Diagnostic tests are categorized as waived if they are simple to use and there is little chance the test will provide wrong information or cause harm if it is performed incorrectly. This bill would allow the source of this bill to employ a lesser skilled individual than is currently required under California law to perform TPRT, a test that screens potential plasma donors. This change would be an exception to state law, but consistent with federal law. Total Protein Refractometer Test (TPRT). As part of donor-screening and quality-assurance procedures, some plasma donation centers perform screening tests on-site, and these screening tests are considered "waived tests," with the exception of the TPRT. While some centers use older, analog refractometers to conduct the test, other centers use newer, digital refractometers, like the instrument described in this bill. FDA assigned TPRT to the moderate complexity category under CLIA, regardless of type. The Plasma Protein Therapeutics Association submitted to the FDA, in an effort to get this instrument reclassified, that the experiences of one of their member centers that use digital refractometers to perform TPRTs "demonstrate that the test is a simple procedure with little health impact." The request for FDA reclassification of TPRT is still pending, but the sponsors believe it will likely be completed by this bill's sunset date of 2019. FISCAL EFFECT: Appropriation: No Fiscal Com.:YesLocal: Yes SUPPORT: (Verified7/14/15) Grifols, Inc. (source) Blood Centers of California KEDPlasma LLC AB 757 Page 6 Octapharma Plasma, Inc. Plasma Protein Therapeutics Association OPPOSITION: (Verified7/14/15) California Association for Medical Laboratory Technology California Society of Pathologists Engineers & Scientists of California, IFPTE Local 20 ARGUMENTS IN SUPPORT: The sponsor, Grifols, Inc., writes, "Currently, the total protein refractometer test unit is categorized by federal CLIA as a 'moderate complexity test.' California law authorizes 17 different categories of health care personnel, subject to varying levels of independence or supervision, to conduct a moderate complexity test. This even includes 'any person' if supervised in a physician's office. In fact, a total protein refractometer test can be administered in the overwhelming majority of states by an employee trained to federal standards. ...The end goal of this measure is to help our California Department of Public Health-licensed plasma donation centers operate more efficiently by authorizing a properly-trained employ to perform this simple task as part of the donor intake process, without diverting other employees from their primary occupations." Plasma Protein Therapeutics Association, Blood Centers of California, KEDPlasma LLC and Octapharma Plasma are in support of this bill because it will help their operations, as well. ARGUMENTS IN OPPOSITION:The California Association for Medical Laboratory Technology, the professional association representing clinical laboratory scientists and other laboratory personnel in California, oppose AB 757, writing, "Plasma donors are paid. They can donate every two weeks if their total protein is at least 6 g/dL. Many plasma collection centers 'bleed' their donors down to 6 g/dL of protein regularly. If the protein refractometer test and/or calibration is done incorrectly and the protein read is higher than it actually is, there is a potential to over 'bleed' a donor causing donor harm, such as death from untreated low protein, immune deficiency, heart and respiratory problems, bruising, insufficient blood clotting, muscle wasting and reduced energy. In short, the current AB 757 Page 7 personnel standard needs to be maintained." The California Society of Pathologists and Engineers & Scientists of California, IFPTE Local 20 also express concern about patient safety and quality control with lesser-trained individuals. ASSEMBLY FLOOR: 74-0, 5/22/15 AYES: Achadjian, Travis Allen, Baker, Bigelow, Bloom, Bonilla, Bonta, Brough, Brown, Burke, Calderon, Campos, Chang, Chau, Chávez, Chiu, Chu, Cooley, Cooper, Dababneh, Dahle, Daly, Dodd, Eggman, Frazier, Beth Gaines, Gallagher, Cristina Garcia, Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez, Gordon, Gray, Grove, Hadley, Harper, Roger Hernández, Holden, Irwin, Jones-Sawyer, Kim, Lackey, Levine, Linder, Lopez, Low, Maienschein, Mathis, Mayes, McCarty, Medina, Melendez, Mullin, Nazarian, Obernolte, Patterson, Perea, Quirk, Rendon, Ridley-Thomas, Rodriguez, Salas, Santiago, Steinorth, Mark Stone, Thurmond, Ting, Wagner, Wilk, Williams, Wood, Atkins NO VOTE RECORDED: Alejo, Jones, O'Donnell, Olsen, Waldron, Weber Prepared by:Sarah Huchel / B., P. & E.D. / (916) 651-4104 7/14/15 19:27:51 **** END ****