BILL ANALYSIS                                                                                                                                                                                                    Ó







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        |Hearing Date:June 11, 2012         |Bill No:AB                         |
        |                                   |761                                |
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                      SENATE COMMITTEE ON BUSINESS, PROFESSIONS 
                               AND ECONOMIC DEVELOPMENT
                          Senator Curren D. Price, Jr., Chair
                                           

                        Bill No: AB 761 Author: Roger Hernandez
                         As Amended: June 4, 2012 Fiscal: Yes

        
        SUBJECT:   Optometrists. 
        
        SUMMARY:  Provides that a laboratory director may include a licensed 
        optometrist and authorizes an optometrist to perform certain clinical 
        laboratory tests or examinations classified as waived under the 
        Clinical Laboratory Improvement Act (CLIA). 

        Existing law:
        
        1) Provides for the licensure and regulation of optometrists by the 
           Board of Optometry (Board).  (BPC § 3010)

        2) Requires certification by the Board for a licensed optometrist to 
           use therapeutic pharmaceutical agents.  (BPC § 3041.3) 

        3) Authorizes a licensed optometrist certified to use therapeutic 
           pharmaceutical agents to diagnose and treat specific conditions.  
           (BPC § 3041(a)(5); § 3041(b)(2)(c) et seq)

        4) Provides for the licensure and regulation of clinical laboratories 
           and personnel by the California Department of Public Health (DPH).  
           (Division 2, Chapter 3, Articles 4-7, Section 1260 et seq. of the 
           Business and Professions Code (BPC); California Code of Regulations 
           (CCR) Title 17, Division 1, Chapter 2.  Often referred to as the 
           "CLIA Law.")

        5) Prohibits the performance of a clinical laboratory test or 
           examination classified as waived under the federal CLIA of 1988 
           unless the test or examination is performed under the overall 
           operation and administration of a laboratory director, as defined, 





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           and is performed by specified persons, including certain health 
           care personnel.  

        This bill:

        1. Expands the category of persons who may perform CLIA waived tests 
           to include licensed optometrists if the results of the tests can be 
           lawfully utilized within their practice.

        2. Provides that a laboratory director may include a licensed 
           optometrist serving as the director of a laboratory which only 
           performs specified CLIA waived tests including the Rapid Pathogen 
           Screening (RPS) Adeno Detector and Tear Osmolarity Test (TOT). 

        3. Authorizes a licensed optometrist certified to use therapeutic 
           pharmaceutical agents to additionally perform specified CLIA waived 
           tests and examinations that are necessary for the diagnosis of 
           conditions and diseases of the eye or ocular adnexa defined as the 
           adjacent structures of the eye including the extraocular muscles 
           and the eyelids, eyelashes, eyebrows and the conjunctiva. 

        FISCAL EFFECT:  According to the Assembly Appropriation Committee 
        analysis dated January 19, 2012, this bill results in additional 
        fee-supported workload at the Department of Public Health in the range 
        of $150,000 annually. 

        COMMENTS:
        
        1. Purpose.  The  California Optometric Association  is the sponsor of 
           the bill.  According to the Author, optometrist may order 
           diagnostic tests from a lab.  The problem is that the patient and 
           doctor must wait for the test results, which can unnecessarily 
           delay appropriate diagnosis and treatment.  Additionally, the 
           patient is often inconvenienced by having to go to a separate 
           location to get a test done that can be sold over the counter.  

        2. Background.   Federal Clinical Laboratory Improvement Amendments of 
           1988 (CLIA).   CLIA law specified that laboratory requirements be 
           based on the complexity of the test performed.  It also established 
           provisions for categorizing a test as waived.  Tests may be waived 
           from regulatory oversight if they meet certain requirements 
           established by the statute.  On February 28, 1992, regulations were 
           published to implement CLIA. 

            Federal Definition of CLIA Waived Tests.   According to Federal 
           Regulation 493.15, CLIA-waived tests are test systems that are 





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           simple laboratory examinations and procedures which are cleared by 
           FDA for home use, employ methodologies that are so simple and 
           accurate as to render the likelihood of erroneous results 
           negligible or pose no reasonable risk of harm to the patient if the 
           test is performed incorrectly.

            California Clinical Laboratory Personnel Requirements.   All persons 
           performing, supervising, consulting on, or directing clinical 
           laboratory tests or examinations in California must meet the 
           requirements outlined in the Business and Professions Code 
           irrespective of whether the clinical laboratory is operated under a 
           CLIA certificate or under a state license or registration.  (CCR 
           Title 17 § 1039.2 (a))

           Currently, optometrists are certified to perform a number of 
           procedures, such as blood draws for patients suspected of having 
           diabetes, suture removal with prior approval of the treating 
           physician and use of an epinephrine auto-injector to counteract 
           anaphylactic reaction. 

            Center for Medicaid Services  (CMS).  The CMS issued a memo in 
           September of 2006 to provide clarification regarding optometrists 
           serving as laboratory directors of moderate complexity testing 
           under CLIA.  The memo states, "The Doctor of Optometry (OD) degree 
           is suitable to meet the personnel qualifications for laboratory 
           director of moderate complexity testing provided the testing is 
           limited to tests related to the medical specialty of optometry."  
           This bill would allow optometrists to administer tests of simple 
           complexity including the RPS Adeno Detector and TOT. 

            RPS Adeno Detector.   The RPS Adeno Detector quickly detects the 
           presence of adenovirus in the tear fluid.  Adenoviral 
           conjunctivitis, such as "pink eye," represents the most common 
           external ocular infection.  This in-office test allows for the 
           rapid detection of Adenoviral antigens directly from human eye 
           fluid on the lower conjunctiva.  RPS Adeno Detector kits do not 
           require additional equipment to administer or interpret. Results 
           are achieved in 
           10 minutes allowing the optometrist to provide a diagnosis and 
           implement a treatment plan before patients leave the office.
            
           TOT.  Dry eye disease is a common condition in which the eye does 
           not produce enough tears to keep the surface of the eye 
           sufficiently lubricated.  The TOT, produced by TearLab Corporation, 
           requires less than 50 nanoliters of tear fluid in order to measure 
           tear osmolarity or fluid of the eye. The TOT can produce a sample 





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           and test result in less than 30 seconds.  
            
        3. Current Related Legislation.  SB 1481  (Negrete McLeod, 2012).  
           Exempts a community pharmacy, which solely provides CLIA-waived 
           tests, from the clinical laboratory regulations requiring that the 
           pharmacy hire a laboratory director who is a licensed physician.  
           Requires that the CLIA-waived test be administered by a pharmacist 
           in the course of performing routine patient assessment procedures.  
           Requires the pharmacy to obtain a Certificate of Waiver from the 
           DPH and comply with all CLIA requirements.  Exempts a pharmacist 
           from state laboratory licensing requirements if the pharmacist only 
           performs CLIA-waived tests.    This measure is currently awaiting a 
           hearing in Assembly Business, Professions and Consumer Protection 
           Committee.

        4. Prior Related Legislation.  SB 1246  (Negrete McLeod, Chapter 523, 
           Statutes of 2010) expanded the category of persons who may perform 
           clinical laboratory tests or examinations that are classified as 
           waived to include licensed naturopathic doctors if the results of 
           the tests can be lawfully utilized within their practice, and 
           expanded the definition of laboratory director to include 
           naturopathic doctors, as specified, for purposes of waived 
           examinations.
           
            SB 1174  (Polanco, Chapter 640, Statutes of 2001) exempted those 
           certified emergency medical technicians and licensed paramedics, 
           providing basic life support services or advanced  life support 
           services, who perform only blood  glucose tests that are classified 
           as waived clinical laboratory  tests under the federal CLIA of 
           1988, from the laws regulating clinical laboratories.  Required the 
           provider of those services to obtain a valid Certificate of Waiver 
           and comply with all other requirements for the performance of 
           waived clinical laboratory tests under applicable federal 
           regulations.

            SB 585  (Chesbro, Chapter 70, Statutes of 1999) permitted a 
           certified nurse midwife, a licensed nurse practitioner, a licensed 
           physician assistant acting under the supervision of a licensed 
           physician, or a licensed dentist to perform clinical laboratory 
           examinations classified as provider-performed microscopy under the 
           federal CLIA of 1988.

            SB 366  (Maddy, Chapter 1141, Statutes of 1994) extended the 
           exemption from state clinical laboratory laws to facilities owned 
           and operated by a partnership or professional corporation of five 
           or fewer physicians and surgeons or podiatrists.  The exemption 





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           applies only if the clinical laboratory tests or examinations are 
           performed for the patients of the physician, podiatrist, 
           partnership or professional corporation.  This law repealed the 
           exemption upon U.S. Department of Health and Human Services 
           recognition of California's conformity with the requirements of 
           federal CLIA of 1988.
        5. Arguments in Support.  The  Sponsor  asserts that the bill will allow 
           optometrists to provide better care to their patients.  Currently, 
           patient safety is compromised because optometrists cannot legally 
           perform these tests during an office visit.   For example, the RPS 
           Adeno Detector can diagnose viral conjunctivitis while the patient 
           is still in the office, which allows the doctor to make an accurate 
           diagnosis and limit spread of disease while simultaneously reducing 
           ocular antibiotic resistance. 

            The American Federation of State, County and Municipal Employees  
           and the  United Nurses Associations of California/Union of Health 
           Care Professionals  also support the bill stating that the current 
           practice of sending tests to a laboratory unnecessarily delays 
           appropriate diagnosis and treatment. 

           The  California Board of Optometry  notes that optometrists can 
           already perform waived tests in a lab under the supervision of a 
           laboratory director.  This bill will improve patient care and 
           public health by allowing optometrists to perform tests 
           independently. 

            TearLab Corporation  indicates that the bill will have a direct 
           impact on the optometrists and their patients who depend on their 
           product to diagnose and manage dry eye disease.  Specifically, the 
           measurement of tear fluid osmolarity for the diagnosis of dry eye 
           disease has been well vetted in peer reviewed clinical studies for 
           over 30 years.  They also indicate that the TOT can only be 
           performed at the doctor's office, as tear fluid is a fragile sample 
           with insufficient volume to allow for collection and transfer to a 
           reference laboratory for analysis. 

        
        SUPPORT AND OPPOSITION:
        
         Support:  

        California Optometric Association (Sponsor)
        American Federation of State, County and Municipal Employees
        California Board of Optometry
        TearLab Corporation





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        United Nurses Associations of California/Union of Health Care 
        Professionals

         Opposition:  

        None received as of June 4, 2012. 



        Consultant:Le Ondra Clark