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
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          |Author:   |Gomez                                                 |
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          |Version:  |June 22, 2015                                         |
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          |Urgency:  |No                     |Fiscal:    |Yes              |
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          |Consultant|Sarah Huchel                                          |
          |:         |                                                      |
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                   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  







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               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.








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             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  








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               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  








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               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  








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               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  








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            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  








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            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  








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            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  








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            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.)








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            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


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