BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                  SB 1481
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          Date of Hearing:   August 16, 2012

                        ASSEMBLY COMMITTEE ON APPROPRIATIONS
                                  Mike Gatto, Chair

               SB 1481 (Negrete McLeod) - As Amended:  August 7, 2012 

          Policy Committee:                             HealthVote:16-0
                       Business and Professions         Vote: 9-0

          Urgency:     No                   State Mandated Local Program: 
          No     Reimbursable:              No

           SUMMARY  

          As proposed to be amended, this bill exempts from existing 
          clinical laboratory requirements and regulations community 
          pharmacies that provide simple blood glucose, hemoglobin A1c, or 
          cholesterol tests, as specified, if the pharmacy obtains a 
          registration from the Department of Public Health (DPH) and 
          other requirements are met.  

           FISCAL EFFECT  

          1)Assuming 20% of pharmacies register as clinical labs: 

             a)   This bill would result in additional fee-supported 
               workload at the DPH of $50,000 annually. 
             b)   Revenue of $120,000 would be generated by existing fees. 
                

          1)Regardless of the final number of pharmacies that register as 
            clinical laboratories, additional fee revenue will be adequate 
            to fund additional workload. Revenues will accrue to the 
            Clinical Laboratory Improvement Fund and be used to fund 
            oversight of the individuals performing laboratory tests.

           COMMENTS  

           1)Rationale  . This bill would allow pharmacists to perform 
            specific over-the-counter laboratory tests, such as glucose 
            level or cholesterol tests, without the need to hire a 
            laboratory director.  This bill would allow pharmacists to 
            perform only specific tests that are already recognized by the 
            law as safe to be performed with little or no oversight.  The 








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            author contends this bill will result in easier access to 
            safe, simple, and economical tests, especially for low income 
            individuals, less crowding in physicians' offices, and an 
            improved ability of pharmacists to provide meaningful feedback 
            to their patients when providing drug consultations required 
            by law.

            The California Pharmacists Association is the sponsor of this 
          bill.

           2)CLIA-Waived Tests  . Under CLIA, the federal Food and Drug 
            Administration (FDA) categorizes laboratory tests based on the 
            complexity of the test performed.  Tests may be assigned to 
            one of three categories: high-complexity, moderate-complexity, 
            or waived from regulatory oversight. Waived tests are defined 
            in federal regulation as simple laboratory examinations and 
            procedures that are cleared by the 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.  This legislation would allow 
            pharmacists to perform three types of CLIA-waived tests.  
            Under current law, with certain exceptions, these tests can 
            only be performed under the oversight of a qualified 
            laboratory director.

           3)Regulation of Clinical Laboratories  . Under current law, an 
            individual performing CLIA-waived clinical laboratory tests is 
            considered a clinical laboratory. Clinical laboratories that 
            perform only CLIA-waived tests are required to register with 
            the Laboratory Field Services unit within CDPH, and pay a 
            $100-per-year fee.  The department's oversight workload 
            consists of reviewing registration applications and ensuring 
            that appropriate personnel are performing allowable types of 
            tests.

           4)Proposed amendments  (a) remove the provision making an 
            registration an biennial requirement for pharmacies (thereby 
            conforming to existing law making registration an annual 
            requirement), and (b) make technical, clarifying, and 
            chaptering changes.


           Analysis Prepared by  :    Lisa Murawski / APPR. / (916) 319-2081 









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