BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                  SB 100
                                                                  Page  1

          Date of Hearing:   August 17, 2011

                        ASSEMBLY COMMITTEE ON APPROPRIATIONS
                                Felipe Fuentes, Chair

                     SB 100 (Price) - As Amended:  July 12, 2011 

          Policy Committee:                             Business and 
          Professions  Vote:                            9-0

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

           SUMMARY  

          This bill increases oversight of outpatient settings by the 
          Medical Board of California (Board), the Department of Public 
          Health, and the bodies that accredit outpatient settings.  
          Specifically, this bill:

          1)Requires the Board to adopt regulations governing physician 
            availability in settings using laser or intense pulse light 
            devices (so-called "medical spa" treatments), adopt standards 
            governing in vitro fertilization in outpatient settings, and 
            make publicly available specified information regarding 
            accreditation of outpatient settings on its web site. 

          2)Authorizes the Board to specify procedures that should be 
            provided in accredited facilities.

          3)Defines additional standards for outpatient settings, 
            including adoption of protocols for urgent care situations and 
            reporting of adverse events to the Department of Public 
            Health.

          4)Requires accrediting agencies to perform a variety of 
            activities that increase oversight of outpatient settings, 
            including complaint investigation, investigation of the prior 
            history of the setting and its licensees, communication to the 
            Board about accreditation status and the results of 
            inspections.

          5)Defines processes and protocols that accrediting agencies and 
            outpatient settings must use when outpatient settings do not 
            comply with accreditation standards, including corrective 








                                                                  SB 100
                                                                  Page  2

            action plans, reprimands, and public posting of information.

          6)Includes clinics that provide in vitro fertilization in the 
            definition of "outpatient setting."

           FISCAL EFFECT  

          1)The requirement to provide data via a publicly accessible 
            website will result in one-time workload cost pressure in the 
            range of $50,000.  The actual cost pressure may be more or 
            less depending on the complexity of the website development 
            and initial data entry needs.

          2)The bill's other requirements, as well as ongoing maintenance 
            of the website, will result in minor and absorbable costs. 



           COMMENTS  

           1)Rationale  . According to the author, this bill provides for 
            greater oversight and regulation of outpatient settings, 
            including "medical spa" facilities and in vitro fertilization 
            clinics, and ensures that quality of care standards are in 
            place at these clinics and checked by the appropriate 
            accrediting agency.  The author indicates that this bill 
            increases consumer protections and increases consumer 
            awareness to protect individuals from unscrupulous providers.

           2)Background  .  Outpatient medical care is generally performed in 
            either clinics licensed by DPH, or in outpatient settings that 
            are not licensed by the state but operate under an individual 
            licensed by the Medical Board of California (Board).  In 
            addition to operating under a Board licensee, outpatient 
            settings that perform procedures using a specified level of 
            anesthesia must be accredited by one of four private 
            accrediting agencies approved by the Board. 

            In recent years, there has been a significant increase in the 
            volume of elective cosmetic surgeries performed in these 
            outpatient settings, and there is evidence of consumer harm 
            associated with this increase.   The well-publicized death of 
            musician Kanye West's mother Donda West in 2007 following a 
            cosmetic procedure in an outpatient setting raised the public 
            profile of these procedures and their safety risks.








                                                                  SB 100
                                                                  Page  3


            Additionally, new technology used in cosmetic procedures is 
            rapidly being introduced, causing concern that there is little 
            oversight over these newer procedures that could pose safety 
            risks to the public.  Many of these new technologies do not 
            require the level of anesthesia that would trigger an 
            accreditation requirement.  Finally, there is concern that 
            even accredited facilities do not have adequate patient 
            protections in place.  By requiring certain patient safety 
            protocols, increased oversight by accrediting agencies, and 
            increased communication between these agencies and the Board, 
            this bill seeks to increase consumer protection for procedures 
            performed in an outpatient setting without requiring more 
            stringent facility licensure.

           3)Prior Legislation  . 

             a)   SB 1150 (Negrete McLeod)  in 2010 contained a number 
               similar provisions to this bill as well as some provisions 
               not in this bill, including a provision regarding 
               professional designation health care practitioner 
               advertising. SB 1150 was held on the suspense file of this 
               committee.
                
             b)   SB 674 (Negrete McLeod) in 2009 was similar to SB 1150.  
               SB 674 was vetoed due to concerns about reliance on 
               external accreditation agencies.  Neither SB 1150 nor SB 
               100 modifies the role of accreditation agencies.
           

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