BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                  AB 491
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          CONCURRENCE IN SENATE AMENDMENTS
          AB 491 (Ma)
          As Amended August 30, 2012
          2/3 vote. Urgency
           
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          |ASSEMBLY:  |     |(May 31, 2011)  |SENATE: |29-3 |(August 31,    |
          |           |     |                |        |     |2012)          |
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           Original Committee Reference:    HEALTH  

           SUMMARY  :  Authorizes two general acute care hospitals to provide 
          cardiac catheterization services in a connected outpatient 
          facility.  

           The Senate amendments :  

          1)Permit, beginning on March 1, 2013, no more than two general 
            acute care hospitals that have applied for program flexibility 
            on or before July 1, 2012, to expand cardiac catheterization 
            laboratory services and utilize cardiac catheterization space 
            outside an acute care general hospital if the following 
            conditions are met:

             a)   The expanded cardiac catheterization laboratory space is 
               located in the building so that the space is connected to 
               the general acute care hospital by an enclosed all-weather 
               passageway that is accessible by staff and patients who are 
               accompanied by staff;

             b)   The service performs cardiac catheterization services on 
               no more than 25% of the general acute care hospital's 
               inpatients who need cardiac catheterizations; and,

             c)   The service complies with the same policies and 
               procedures approved by hospital medical staff for cardiac 
               catheterization laboratories that are located within the 
               general acute care hospital, and the same standards and 
               regulations prescribed by the Department of Public Health 
               (DPH), for cardiac catheterization laboratories located 
               inside general acute care hospitals.  Those standards 
               include appropriate nurse-to-patient ratios, and all 
               standards and regulations prescribed by Office of Statewide 
               Health Planning and Development (OSHPD).








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          2)Require emergency regulations permitting a general acute care 
            hospital to operate expanded cardiac catheterization 
            laboratory services to be adopted by DPH and OSHPD by February 
            28, 2013.

          3)Require, by March 1, 2014, DPH and OSHPD to promulgate formal 
            regulations that provide adequate protection to patient health 
            and safety. 

          4)Require cardiac catheterization laboratory services to be 
            reviewed by OSHPD for compliance with the OSHPD-3 requirements 
            of the most recent version of the California Building 
            Standards Code.

          5)Add and urgency clause requiring the provisions of this bill 
            to go into immediate effect.

           
          EXISTING LAW  :  

          1)Licenses and regulates general acute care hospitals by DPH.

          2)Permits a general acute care hospital to be approved to offer 
            special services, in addition to the basic services offered 
            under their license, including cardiac surgery and cardiac 
            catheterization laboratory services.

          3)Requires a cardiac catheterization laboratory service to be 
            located in a general acute care hospital that is either 
            licensed to perform cardiovascular procedures requiring 
            extracorporeal coronary artery bypass, or have a licensed 
            intensive care service and coronary care service and maintain 
            a written agreement for the transfer of patients to a general 
            acute care hospital that is licensed for cardiac surgery.

          4)Prohibits, except as specified, cardiac catheterizations from 
            being performed outside of a general acute care hospital or a 
            multispecialty clinic, as defined.

          5)Establishes the Alfred E. Alquist Hospital Facilities Seismic 
            Safety Act of 1983 (Seismic Safety Act), which establishes 
            requirements for health care facilities under the jurisdiction 
            of OSHPD.  









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          6)Exempts from the definition of "hospital building," for 
            purposes of the Seismic Safety Act, any building where 
            outpatient clinical services of licensed health facility are 
            provided.  Specifies that if any one or more outpatient 
            clinical services in the building provides services to 
            inpatients, the building shall not be included as a "hospital 
            building" if those services provided to inpatients represent 
            no more than 25% of the total outpatient services provided at 
            the building.

          7)Permits DPH to license a freestanding cardiac catheterization 
            laboratory that was part of a Health Care Pilot Project 
            testing the feasibility of performing diagnostic 
            catheterization procedures in a freestanding laboratory.  
            Subjects these freestanding cardiac catheterization 
            laboratories to the DPH regulations governing cardiac 
            catheterization laboratories operating in hospitals without 
            facilities for cardiac surgery. 

           AS PASSED BY THE ASSEMBLY  , this bill revised existing law that 
          sets forth requirements for medical providers in clinical 
          settings, at the time a test for Human immunodeficiency virus 
          (HIV) is administered, to include HIV counselors in nonclinical 
          settings, to require informed consent, as specified, and to 
          specify information that must be shared.

           FISCAL EFFECT  :  According to the Senate Appropriations 
          Committee, this bill will result in the following fiscal impact:

          1)One-time costs up to $150,000 to the Hospital Building Fund 
            for OSHPD to adopt regulations.

          2)One-time costs up to $150,000 to the Licensing and 
            Certification Program Fund for DPH to adopt regulations.
           COMMENTS  :  According to the American College of Cardiology (ACC) 
          and the American Heart Association (AHA), during the past four 
          decades an evolution in cardiac catheterization has taken place. 
           The ACC and AHA indicate that the role of the cardiac 
          catheterization laboratory has progressed from study of cardiac 
          function and anatomy for purposes of diagnosis to evaluation of 
          candidates for surgery and finally to providing catheter-based, 
          nonsurgical interventional treatment.  According to the National 
          Heart Lung and Blood Institute, cardiac catheterization is a 
          common procedure used to diagnose and treat a wide variety of 
          heart problems in adults and children.  During a cardiac 








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          catheterization, the cardiologist inserts a small, hollow tube 
          (catheter), into an artery or vein, and then guides it into the 
          heart using an X-ray.  The cardiologist injects contrast (X-ray 
          dye) through the catheter to outline the arteries and to show 
          any blockages or a narrowing that may exist.  A cardiac 
          catheterization laboratory is equipped with digital imaging 
          equipment and computers for fluoroscopy and cineangiogram 
          (movies of the heart) that allow for precise quantitative 
          evaluation of heart problems. 

          Existing law specifies that a cardiac catheterization laboratory 
          must be located in a general acute care hospital.  OSHPD 
          administrative regulations specify that cardiac catheterization 
          laboratories located within a general acute care hospital must 
          be in a building built to the OSHPD-1 building standards.  
          OSHPD-1 buildings must comply with the Seismic Safety Act and 
          fall under the auspices of OSHPD.

          The building adjacent to the hospital where cardiac 
          catheterization services will be provided, as proposed by this 
          bill, would be built to the OSHPD-3 standards.  OSHPD-3 
          buildings are built to the same structural requirements of any 
          commercial building.  They are not under the jurisdiction of 
          OSHPD but, instead, are under the jurisdiction of the local 
          building department.  OSHPD-3 buildings are also exempt from the 
          Seismic Safety Act.
          
           The provisions in this bill would apply to two general acute 
          hospitals, Cedars-Sinai Medical Center (Cedars) and Scripps 
          Health (Scripps).  Cedars states that it is constructing a new 
          800,000 square foot building on the campus called the Advanced 
          Health Science Pavilion (AHSP).  Cedars states that the AHSP 
          will primarily house outpatient services and advanced clinical 
          research activities.  According to Cedars, one full floor will 
          be devoted to outpatient surgery, including surgery and 
          interventional radiology suites, and two cardiac catheterization 
          laboratories.  Cedars states that the AHSP is immediately 
          adjacent to the seismically compliant main hospital building and 
          will be connected to the hospital at the fifth floor surgery 
          level by a fully approved and enclosed OSHPD Level 1 bridge.  
          Cedars states that it is one of the largest cardiac care 
          providers in California, providing 5,000 cardiac catheterization 
          procedures per year, and that these new facilities will allow it 
          to serve patients in a more convenient and accessible way.









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          Scripps Health indicates that it is in the planning stages of 
          building a Scripps Clinic Medical Office Building (MOB) that 
          would offer cardiac catheterization services.  The MOB would be 
          located in a building that is adjacent to the Scripps Prebys 
          Cardiovascular Institute currently under construction; both 
          which will be located on the campus of Scripps Memorial 
          Hospital.

          The California Hospital Association (CHA) writes in support of 
          this bill that with the passage of the federal Patient 
          Protection and Affordable Care Act, California will see an 
          increase in patients seeking access and care in a health system 
          that is already challenged with limited resources and capacity.  
          According to CHA, in order to provide increased services to 
          these newly covered patients, California hospitals will need to 
          utilize all resources available in order to treat patients in a 
          timely efficient manner.  CHA maintains that OSHPD currently 
          allows up to 25% of procedures on inpatients to be performed in 
          an outpatient setting, and that this legislation is necessary to 
          conform DPH authority that currently restricts inpatient cardiac 
          catheterization services to an acute care setting. According to 
          CHA, this bill would allow no more than 25% of cardiac 
          catheterization laboratory inpatient services to be performed in 
          an appropriately equipped and staff outpatient setting.  CHA 
          notes that should an emergency arise that requires cardiac 
          surgery service support, this bill requires the outpatient 
          cardiac catheterization space to be located in a building 
          connected by an enclosed all-weather patient passageway to a 
          general acute care hospital.

          The California Nurses Association (CNA) writes that they are 
          strongly opposed to this bill.  CNA asserts that there is no 
          real urgency to this measure and they are opposed to the end of 
          session "gut and amend" which circumvents the full vetting of a 
          legislative session.  CNA argues that this bill skirts the 
          seismic requirements and the existing hospital regulations for 
          cardiac catheterization laboratories by being licensed under 
          OSHPD-3 building standards as opposed to OSHPD-1 building 
          standards.  CNA also states that they are opposed to the use of 
          the emergency regulation process for the adoption of regulations 
          for such high risk procedures and that the emergency regulation 
          process denies DPH the benefit of consumer input.

          This bill was substantially amended in the Senate and the 
          Assembly-approved version of this bill was deleted.  This bill, 








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          as amended in the Senate, is inconsistent with Assembly actions.


           Analysis Prepared by  :   Tanya Robinson-Taylor / HEALTH / (916) 
          319-2097


          FN: 0005875