BILL ANALYSIS                                                                                                                                                                                                    Ó



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          Date of Hearing:  April 14, 2015


                   ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS


                                Susan Bonilla, Chair


          AB 599  
          (Bonilla) - As Amended April 6, 2015


          SUBJECT:  Clinical laboratories:  cytotechnologists.


          SUMMARY:  Authorizes a licensed cytotechnologist to perform all  
          tests and procedures pertaining to cytology.


          EXISTING LAW


          Federal Clinical Laboratory Improvement Amendments of 1988  
          (CLIA)


          1)Establishes the federal program for certification and  
            oversight of clinical laboratories under the Centers for  
            Medicaid and Medicare Services (CMS). (United States Code,  
            Title 42, § 263a)


          2)Establishes the conditions that laboratories must meet for  
            certification to perform testing on human specimens under  
            CLIA. (Code of Federal Regulations (CFR), Title 42, § 493.1)


          3)Requires that laboratories certify that each person examining  








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            cytology slide preparations meet either of the following  
            requirements: (42 CFR § 493.1483)


             a)   Be a doctor of medicine or a doctor of osteopathy  
               licensed to practice medicine or osteopathy in the state in  
               which the laboratory is located; and,


               i)     Meet one of the following requirements:


                  (1)       Be certified in anatomic pathology by the  
                    American Board of Pathology or the American  
                    Osteopathic Board of Pathology or possess  
                    qualifications that are equivalent to those required  
                    for such certification; or,


                  (2)       Be certified by the American Society of  
                    Cytology to practice cytopathology or possess  
                    qualifications that are equivalent to those required  
                    for such certification. 


             b)   Possess a current license as a cytotechnologist issued  
               by the state in which the laboratory is located, if such  
               licensing is required; and,


               i)     Meet one of the following requirements:


                  (1)       Have graduated from a school of cytotechnology  
                    accredited by the Committee on Allied Health Education  
                    and Accreditation or other organization approved by  
                    the U.S. Department of Health and Human Services  
                    (HHS); or,









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                  (2)       Be certified in cytotechnology by a certifying  
                    agency approved by HHS.


          4)Requires that all cytology slide preparations be evaluated on  
            the premises of a laboratory certified to conduct testing in  
            the subspecialty of cytology and requires the laboratories to  
            establish written policies and procedures for staining, error  
            controls, workload limits, slide retention, automated and  
            semi-automated screening devices, and documentation. (42 CFR §  
            493.1274)


          5)Requires the laboratory to require a cytotechnologist to  
            document: (42 CFR § 493.1485)


             a)   The slide interpretation results of each gynecologic and  
               nongynecologic cytology case he or she examined or reviewed  
               (as specified in § 493.1274(c));


             b)   For each 24-hour period, the total number of slides  
               examined or reviewed in the laboratory as well as the total  
               number of slides examined or reviewed in any other  
               laboratory or for any other employer; and,


             c)   The number of hours spent examining slides in each  
               24-hour period. 


          California Business and Professions Code (BPC)


          1)Provides for the licensure, registration, and regulation of  
            clinical laboratories and various clinical laboratory  
            personnel, including cytotechnologists, by the California  








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            Department of Public Health (CDPH). (BPC § 1200-1327)


          2)Defines "diagnostic cytology" as a subspecialty under the  
            specialty of pathology. (BPC § 1206(a)(18)


          3)Defines "cytological slides" as cellular materials submitted  
            for preliminary cytologic examination. (BPC § 1211.5)


          4)Prohibits a person from performing examinations of cytological  
            slides unless they have either a cytotechnologist license  
            issued by the CDPH or a valid physician's and surgeon's  
            certificate. (BPC § 1270)


          5)Establishes a workload limit on the number of gynecological  
            slides a cytotechnologist can examine in a specific period of  
            time. (BPC § 1271)


          6)Requires the CDPH to establish standards for the evaluation of  
            cytological slides and for reporting the adequacy of  
            cytological slides. (BPC § 1272.4)


          THIS BILL


          1)Authorizes a licensed cytotechnologist to perform all tests  
            and procedures pertaining to cytology.


          2)Provides examples of tests and procedures pertaining to  
            cytology, including: 


             a)   Microscopic and nonmicroscopic methodologies; and, 








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             b)   Tests and procedures that use molecular or genetic  
               methodologies that are performed on cytologic specimens  
               related to infectious disease or cancer diagnoses.


          3)Makes other technical, nonsubstantive changes. 


          FISCAL EFFECT:  Unknown. This bill is keyed fiscal by the  
          Legislative Counsel.


          COMMENTS


          1)Purpose. This bill is sponsored by the  California Society of  
            Pathologists  and the  California Association of  
            Cytotechnologists.  According to the author, this bill,  
            "ensures that California law is updated as technology  
            advances.  More importantly, it ensures that we keep  
            high-paying jobs here, in California.  We train  
            cytotechnologists but cannot keep them in the state because of  
            our restricted statutory structure.  In addition, labs send  
            samples out of state to be analyzed because they cannot find  
            enough cytotechnologists." 


            "AB 599 ameliorates this situation and keeps jobs in  
            California, removes an incentive to send tissue samples out of  
            state, and ensures that we have the workforce needed to fill  
            laboratory need in California."


          2)Background.  A cytotechnologist is a type of laboratory  
            technician that performs tests specific to the field of  
            cytology.  According the National Institutes of Health (NIH),  
            cytology is the analysis of cells collected from a part of the  








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            body under a microscope. 


            Cytological tests are used to determine what the cells look  
            like and whether they are abnormal.  Abnormal cells are  
            indicators of cancer and precancerous changes.  The tests may  
            also be used to look for viral infections in cells.  A  
            cytological test differs from a biopsy in that only cells are  
            examined, not pieces of tissue.


            Common cytological tests are performed using cells shed from  
            the lining of an organ into a cavity where they can be removed  
            by noninvasive means (exfoliative and aspirative cytology),  
            such as:


             a)   Papanicolaou test (Pap test) - a test for cervical  
               cancer, where cells scraped from the opening of the cervix  
               are examined under a microscope.


             b)   Cytology exam of pleural fluid - a test to detect cancer  
               cells and certain other cells in the pleural space, the  
               area that surrounds the lungs.  A fluid sample is collected  
               from the pleural space and is examined under a microscope.


             c)   Cytology exam of urine - a test used to detect cancer  
               and other diseases of the urinary tract. A urine sample is  
               collected examined under a microscope.


             d)   Cytology exam of sputum - a test used to detect  
               respiratory diseases, including cancer.  A sputum sample  
               (mucus) is collected and examined under a microscope. 


            For those tests, the examining physician, physician assistant,  








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            or nurse practitioner will collect the sample.  Usually, the  
            sample will then be sent to a laboratory where a  
            cytotechnologist will perform a preliminary examination of the  
            sample.  If the cytotechnologist finds an abnormality, a  
            pathologist will perform a final review.  The pathologist  
            reports the final diagnosis back to the examining physician. 


            Non-microscopic Tests.  Under current state law, licensed  
            cytotechnologists are limited to the examination of cells  
            using a microscope, such as the tests noted above.  However,  
            the sponsors note that advances in medicine and laboratory  
            technology have resulted in new techniques that are not  
            limited to a microscope.  Because the new techniques are not  
            limited to microscopes or slides, cytotechnologists are not  
            able to perform them. 


            For instance, historically, the standard of care for the  
            screening of cervical cancer has been the Pap test.  However,  
            an emerging standard for women age 30-65 is "co-testing"-a Pap  
            test in conjunction with a human papillomavirus (HPV) DNA test  
            (Cervical Cancer: Screening Recommendations, U.S. Preventive  
            Services Task Services (USPSTF)).  During a co-test, the Pap  
            test and the HPV test are performed on the same sample.  The  
            USPSTF, along with the American Cancer Society (ACS), has  
            established the co-testing standard due to the high  
            correlation between HPV infection and cervical cancer. 


            In California, cytotechnologists have always been able to  
            examine samples for Pap tests. However, some of the techniques  
            used to test for HPV involve molecular and genetic tests that  
            are not considered examinations of cytological slides as  
            defined under the law.  For instance, one common technique  
            involves the use of a polymerase chain reaction assay (PCR).   
            The PCR is a molecular test performed with a PCR machine, not  
            a microscope.









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            There are also lesser used genetic tests, like the in situ  
            hybridization (ISH) tests.  For example, the fluorescent in  
            situ hybridization (FISH) test is used to detect chromosomal  
            or DNA abnormalities using a specialized microscope.  While it  
            does involve microscopes, they use special preparations of  
            cells to look at the DNA within the cells. 


            The law, as currently written, does not allow  
            cytotechnologists to perform PCR or ISH tests. If one of the  
            tests needs to be performed, the sample would need to be sent  
            to another department in the laboratory.  However,  
            cytotechnologists are often trained in the areas of molecular  
            biology and cellular genetics.  For instance, the CDPH  
            requires cytotechnologists to pass the American Society of  
            Clinical Pathologists (ASCP) cytotechnologist exam (or an  
            equivalent).  The ASCP exam tests the preparation, theory, and  
            application of, among other things, molecular testing  
            (including HPV) and FISH tests. 


            Therefore, the author and the sponsors note that the situation  
            incentivizes cytotechnologists to leave the state.  This bill  
            proposes to fix this issue by expanding the scope of practice  
            of a licensed cytotechnologist to include all tests and  
            procedures pertaining to cytology.  This will allow a  
            cytotechnologist to perform the co-testing on a single sample,  
            without having to send it out.


            Federal Law and Other States.  Under federal law, CLIA  
            regulates laboratories and requires that laboratories apply  
            for certification with CMS.  CLIA certification requires  
            laboratories to certify the qualifications of the personnel it  
            uses, including cytotechnologists. However, it does not  
            license the cytotechnologists individually or provide  
            individual standards.  Therefore, it is up to the individual  
            states to decide the composition of the actual licensing  








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            schemes.  In states that do not have their own regulations,  
            the laboratories determine the tests a cytotechnologist  
            performs (subject to the CLIA procedural and qualification  
            requirements). 


            California is currently the only state that limits the tests a  
            cytotechnologist can provide.  At least five other states that  
            provide for the regulation of cytotechnologists appear to  
            permit cytotechnologists to perform the tests noted above,  
            including: Florida, New York, Tennessee, Louisiana, and  
            Nevada. 


          3)Current Related Legislation.  AB 940 (Ridley-Thomas) of the  
            current legislative session, would add two new license  
            categories, reproductive biology and biochemical genetics,  
            permit clinical laboratory co-directors substantially comply  
            with CLIA requirements, and makes other sustentative and  
            nonsubstantive changes.  STATUS: This bill is pending in the  
            Assembly Committee on Business and Professions.


            AB 757 (Gomez)  This bill would authorize a medical assistant,  
            as defined, who meets specified criteria to perform a total  
            protein refractometer test analysis in a licensed plasma  
            collection facility in this state.  STATUS: This bill is  
            pending in the Assembly Committee on Business and Professions.


          4)Previous Related Legislation.  AB 1215 (Gomez), Chapter 199,  
            Statutes of 2013, expanded the definition of "laboratory  
            director" for purposes of a clinical laboratory test or  
            examination classified as waived to include a duly licensed  
            clinical laboratory scientist and a duly licensed limited  
            clinical laboratory scientist. 


            AB 1328 (Pan) of 2011 would have authorized the CDPH to issue  








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            a clinical laboratory scientist's license to an applicant who  
            completes at least 2 years of full-time employment as a  
            clinical laboratory scientist 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 the department, subject to  
            the payment of the requisite licensing fee.  NOTE: This bill  
            failed passage in the Senate Committee on Business,  
            Professions and Economic Development.


            AB 1370 (Matthews) of 2005 would have included a pharmacist  
            within the definition of laboratory director if the clinical  
            laboratory test or examination is a routine patient assessment  
            procedure, as defined.  NOTE: This bill died pursuant to Art.  
            IV, Sec. 10(c) of the Constitution. 


          ARGUMENTS IN SUPPORT 


          The  California Association of Cytotechnologists  (co-sponsor),  
          the  California Society of Pathologists  (co-sponsor), and other  
          supporters write in support of this bill.  They all generally  
          agree that: 1) cytotechnologists should be able to perform  
          cytological tests that are not limited to a microscope; 2) the  
          fact that California is behind the other states on this issue  
          contributes to the cytotechnologist workforce shortage; and 3)  
          it makes sense to allow a cytotechnologist to perform both a Pap  
          test and HPV test on a single cytological sample. 


          ARGUMENTS IN OPPOSITION


          None on file.


          IMPLEMENTATION ISSUES








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          1)BPC § 1271 places workload limits on the gynecological slides  
            a cytotechnologist can examine.  The new techniques permitted  
            under this bill, unless they involve a gynecological slide,  
            will not be subject to this restriction.


          REGISTERED SUPPORT / OPPOSITION:




          Support


          California Association of Cytotechnologists (co-sponsor)


          California Society of Pathologists (co-sponsor)


          American Society for Clinical Pathology


          American Society of Cytopathology


          California Clinical Laboratory Association


          California Hospital Association


          2 physicians


          1 cytotechnologist









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          Opposition


          None on File.




          Analysis Prepared by:Vincent Chee / B. & P. / (916) 319-3301