BILL ANALYSIS                                                                                                                                                                                                    Ó



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          CONCURRENCE IN SENATE AMENDMENTS


          AB  
          614 (Brown)


          As Amended  June 2, 2015


          Majority vote


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          Original Committee Reference:  HEALTH


          SUMMARY:  Authorizes the California Department of Public Health  
          (DPH) to use a streamlined administrative process to update  
          regulatory references to health care standards of practice  
          adopted by a state or national association when outdated  
          standards are referenced in the California Code of Regulations  
          (CCR).


          The Senate amendments update the definition of eating disorders  
          to reference the Diagnostic and Statistical Manual of Mental  
          Disorders, as published by the American Psychiatric Association.


          EXISTING LAW:  Establishes DPH to license health facilities and  
          requires DPH to adopt, amend or repeal, as specified, any  
          reasonable rules and regulations as may be necessary or proper  
          to carry out the exercise of its power.  Establishes, under the  
          Administrative Procedures Act (APA), a process for adopting,  








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          amending, or repealing regulations.


          FISCAL EFFECT:  According to the Senate Appropriations  
          Committee, pursuant to Senate Rule 28.8, negligible state costs.


          COMMENTS:  According to the author, this bill will eliminate the  
          need to revise regulations simply to update references to the  
          most recent standards of practice when applicable.  The author  
          states that this will result in an efficient and cost effective  
          method for ensuring that health facilities and DPH are  
          referencing standards and providing care that is consistent with  
          the most current nationally recognized professional standards,  
          improving the quality of patient care provided in licensed  
          health facilities.


          The regulatory process, governed by the APA and enforced by the  
          Office of Administrative Law (OAL) is designed to provide the  
          public with a meaningful opportunity to participate in the  
          adoption of regulations or rules that have the force of law and  
          to ensure the creation of an adequate record for the public,  
          OAL, and judicial review.


          Generally, there are two types of rulemaking procedures that a  
          state agency can pursue: regular or emergency.  The regular  
          rulemaking process requires that a state agency meet certain  
          public hearing and notice requirements.  The emergency  
          rulemaking process has different requirements, which generally  
          include a brief public notice period, a finding of emergency, a  
          brief public comment period, review by OAL and an OAL decision.   
          For the regular rulemaking process, once a state agency decides  
          to conduct a rulemaking action, it develops four documents  
          required during the preliminary stage:  1) the proposed text; 2)  
          the Initial Statement of Reasons; 3) the Fiscal Impact  
          Statement; and, 4) the Notice of Proposed Regulatory Action  
          (notice).


          The APA requires at a minimum a 45-day opportunity to comment to  








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          the agency, in writing, on the proposed regulation.  An agency  
          has the option as to whether it will hold a public hearing on a  
          proposed rulemaking action.  However, if an agency does not  
          schedule a public hearing, any interested person can submit a  
          written request within a specified timeframe requesting one to  
          be held, and the agency must then give notice and hold a public  
          hearing.


          A rulemaking agency must summarize and respond on the record to  
          timely comments that are directed at the proposal or at the  
          procedures followed by the agency during the regulatory action.   
          With each comment, the agency must either:  1) explain how it  
          has amended the proposal to accommodate the comment; or, 2)  
          explain the reasons for making no change to the proposal.  The  
          summary and response to comments is included as part of the  
          rulemaking file in the Final Statement of Reasons.


          According to DPH, their experience is that a relatively simple  
          regulation packet could move through the process in as few as 15  
          months to 18 months, regulations pertaining to more complicated  
          subject matter can sometimes take several years, depending on  
          the volume of public comments.


          Nationally recognized professional organizations use industry  
          expertise, information gathered through research, patient  
          outcomes, and best practices to develop standards that are  
          accepted in various medical professions for providing the  
          highest quality of care possible.  For example, the American  
          Academy of Pediatrics publishes a wide variety of clinical  
          practice guidelines on a range of subjects including:  The  
          Diagnosis, Management, and Prevention of Bronchiolitis,  
          Management of Newly Diagnosed Type 2 Diabetes Mellitus in  
          Children and Adolescents, and Treatment of the School-Aged Child  
          With Attention-Deficit/Hyperactivity Disorder, to name a few.


          There are approximately 30 references to outdated standards of  
          practice in CCR Title 22 (which apply to various health  
          facilities, including clinics, and general acute care  








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          hospitals), some of which are referenced in more than one place,  
          and dating as far back as 1961.  The American Dietetic  
          Association standards of practice referenced for educational  
          programs for dietetic service staff in general acute care  
          hospitals were adopted in June 1974.  DPH is currently in the  
          process of updating Title 22.  Some of the regulatory packets  
          could be completed later this year, other more complex packets  
          will take several years to complete, and due to the volume  
          (Title 22 effects up to 30 different types of health facilities)  
          DPH estimates that the entire update will not be complete until  
          sometime in 2025.  Currently, health facilities affected by  
          regulations which reference outdated standards of practice are  
          requesting program flexibility from DPH to allow them to operate  
          using more current medical standards.


          DPH is the sponsor of this bill and notes they are the  
          enforcement and regulatory agency for approximately 30 different  
          types of health care facilities and clinics, and they have a  
          backlog of regulations that are subject to the APA.  DPH  
          contends that in order to remain compliant with up-to-date  
          clinical practices instead of being errantly held to antiquated  
          practices in state regulations, facilities must request program  
          flexibility from DPH, and this additional step creates hurdles  
          for health facilities and clinics.  DPH concludes that this bill  
          will eliminate the need to revise regulations simply to update  
          references to the most recent standards of practice.


          There is no known opposition to this bill.


          Analysis Prepared by:                                             
                          Lara Flynn / HEALTH / (916) 319-2097  FN:  
          0001201















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