BILL ANALYSIS Ó SENATE COMMITTEE ON BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT Senator Jerry Hill, Chair 2015 - 2016 Regular Bill No: AB 757 Hearing Date: June 29, 2015 ----------------------------------------------------------------- |Author: |Gomez | |----------+------------------------------------------------------| |Version: |June 22, 2015 | ----------------------------------------------------------------- ---------------------------------------------------------------- |Urgency: |No |Fiscal: |Yes | ---------------------------------------------------------------- ----------------------------------------------------------------- |Consultant|Sarah Huchel | |: | | ----------------------------------------------------------------- Subject: Healing arts: clinical laboratories. SUMMARY:1) 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. Existing state law: 1)Provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel, including cytotechnologists, by the California Department of Public Health (DPH). (Business and Professions Code (BPC) §§ 1200-1327) 2)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 (Gomez) Page 2 of ? 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 while providing prehospital medical care, 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, who provides direct patient care, if the person is performing the test as an adjunct to the provision of direct patient care by the person, is utilizing a point-of-care laboratory testing device at a site for which a laboratory license or registration has been issued, meets the minimum clinical laboratory education, training, and experience requirements set forth in regulations adopted by the department, and has demonstrated to the satisfaction of the laboratory director that he or she is competent in the operation of the point-of-care laboratory testing device for each analyte to be reported. 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, and shall do both of the following: i) Ensure that the person is performing test methods as required for accurate and reliable tests. ii) Have personal knowledge of the results of the clinical laboratory testing or examination performed by that person before the test results are reported from the laboratory. AB 757 (Gomez) Page 3 of ? aa) A pharmacist. (BPC § 1206.5) 3)Declares Legislative intent to sustain the integrity of California's laboratory standards, including its personnel standards, and that changes in technology to increase the efficiency of health care delivery be accommodated when the providers of laboratory services utilizing technology remain competent to provide accurate, reliable, and necessary test results. (Uncodified language from SB 113 (Maddy) Chapter 510, Statutes of 1995) 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) 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 licensed to practice medicine in the state in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or edical 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 (Laboratory Technician). d) Has earned a high school diploma or equivalent and documentation of training appropriate for the testing performed prior to analyzing patient specimens. Such AB 757 (Gomez) Page 4 of ? training must ensure that the individual has: i) Skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens. ii) Skills required for implementing all standard laboratory procedures. iii) Skills required for performing each test method and for proper instrument use. iv) Skills required for preventive maintenance, troubleshooting and calibration procedures related to each test performed. v) A working knowledge of reagent stability and storage. vi) The skills required to implement the quality control policies and procedures of the laboratory. vii) An awareness of the factors that influence test results; and, viii) The skills required to assess and verify the validity of patient test results through the evaluation of quality control sample values prior to reporting patient test results. (42 CFR § 493.1423) 4)Requires the laboratory director to be responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. Among other duties, the laboratory director is required to: a) Employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described in AB 757 (Gomez) Page 5 of ? this subpart; b) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. (42 CFR § 493.1407) 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 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 AB 757 (Gomez) Page 6 of ? 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. FISCAL EFFECT: This bill is keyed "fiscal" by the Legislative Counsel. According to the Assembly Appropriations Committee analysis dated May 13, 2015, this bill has a negligible state fiscal effect. COMMENTS: 1.Purpose. This measure is sponsored by Grifols, Inc., a company that, among other lines of business, owns and operates 147 plasma donor centers where plasma is collected to be used in the company's protein therapies. This bill would allow the company 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. According to the Author's office, "California law authorizes 17 different categories of health care personnel ([including] 'any person' in a doctor's office) to conduct the total protein refractometer test?. "AB 757 will authorize a fully-trained and fully-supervised employee, whose general training meets that required by federal standards, followed by specific training to operate a one-button, automated, total protein refractometer test in our AB 757 (Gomez) Page 7 of ? licensed plasma collection centers in California. The bill allows the highly qualified physicians, laboratory directors, and other health care professionals on-site to serve more plasma donors while continuing to supervise the operation of the simple, almost entirely automated, total protein refractometer test. "This would not only ensure efficiency and better service delivery at these licensed facilities, but would also allow highly qualified physicians and surgeons to serve more patients while continuing to supervise the administration of this simple, almost entirely automated total protein refractometer test analysis." 2.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 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. 3.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 AB 757 (Gomez) Page 8 of ? 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 intended users of digital refractometers are donation-center employees who have prior training in blood borne pathogens, also known as universal precautions; in the hands of these test operators, the total protein test by digital refractometer is a simple procedure?. "While older, analog refractometers require water calibration ? digital refractometers offer accurate, simple, electronic, water calibration at the push of a button. Digital refractometers are battery-operated, portable, and automatic and measure accurately, consistently from technician to technician, and electronically the same scale as analog refractometers. While older, analog refractometers require trained operators with experience and knowledge of proper use, simple operational software and interface-onscreen instructions guide technicians through digital-refractometer results." 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. 4.Related Legislation. AB 940 (Ridley-Thomas) of 2015 adds the specialty of reproductive biology and the subspecialty of biochemical genetics and makes conforming changes, removes the requirement that clinical laboratory co-directors substantially comply with federal CLIA requirements, and makes other technical and conforming changes. Status : This bill is scheduled to be heard in the Senate Committee on Business, Professions, and Economic Development on June 29, 2015. AB 599 (Bonilla) of 2015 expands the scope of practice for a licensed cytotechnologist by authorizing the performance of all tests and procedures pertaining to cytology under the supervision of a laboratory director. Status : This bill is currently in the Senate Committee on Appropriations. 5.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 AB 757 (Gomez) Page 9 of ? 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. However, California law does not authorize this simple, almost entirely automated test to be conducted by a highly trained and supervised employee at a licensed plasma donation center, unless they are covered by the current roster of license categories?. AB 757 (a) allows a specially trained employee, (b) in the unique and limited setting of a plasma donation facility, (c) to operate a virtually automated test with the push of one button, (d) under an array of supervisory, licensed health care personnel - including the responsible physician and surgeon and/or other licensed facility manager. 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. 6.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, "At issue are the safety of plasma donors and the competency of personnel who test them for donor eligibility. "AB 757 would allow lesser trained and educated persons than currently permitted by law to perform a total protein refractometer analysis, categorized as a moderately complex test by the FDA, in a licensed plasma collection facility. The primary function of the total protein analysis is to provide an accurate and precise value in order to ensure donor safety prior to donating plasma. An erroneously performed AB 757 (Gomez) Page 10 of ? analysis, like a false negative result, which allows the plasma center to proceed with the donation, could cause significant donor harm. As a result, the regulatory agencies have mandated that the individuals performing the total protein test must have demonstrated a higher level of education and training such as those individuals listed in BPC section 1206.5 (b)." "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 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. 7.Policy Consideration. Although TPRT is classified as a moderate complexity test under CLIA, the sponsors argue that advances in technology have made the digital refractometer, an instrument that performs the test, so simple that it should be considered "waived." Were it classified as such, the sponsors would have much more personnel latitude according to existing California law and likely would not need this bill. However, the FDA has not yet begun a reclassification process, though there is a pending request for it to do so. Uncodified language from the 1995 bill that incorporated CLIA into California law declared Legislative intent "to sustain the integrity of California's laboratory standards, including its personnel standards, and that [any] changes in technology to increase the efficiency of health care delivery be accommodated when the providers of laboratory services utilizing technology remain competent to provide accurate, reliable, and necessary test results," SB 113 (Maddy, Chapter 510, Statutes of 1995.) AB 757 (Gomez) Page 11 of ? This bill may be viewed as either a request to make an exception to California's higher standards for personnel performing moderate complexity tests or a premature move in advance of FDA reclassification to streamline operator requirements. The sponsors do not indicate a lack of sufficient personnel under current law, but rather express preference to better allocate skilled resources. SUPPORT AND OPPOSITION: Support: Grifols, Inc. (Sponsor) Blood Centers of California KEDPlasma LLC Octapharma Plasma, Inc. Plasma Protein Therapeutics Association Opposition: California Association for Medical Laboratory Technology California Society of Pathologists Engineers & Scientists of California, IFPTE Local 20 -- END --