BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                AB 491
                                                                Page  1

        ( Without Reference to File)  

        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 30,    |
        |           |     |                |        |     |2012)          |
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                  (vote not relevant)


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        |COMMITTEE VOTE:  |10-1 |(August 31, 2012)   |RECOMMENDATION: |concur    |
        |                 |     |                    |                |          |
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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 








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             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).

        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 








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          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.  

        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 








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        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 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 








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        cardiac catheterization procedures per year, and that these new 
        facilities will allow it to serve patients in a more convenient and 
        accessible way.

        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.









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        This bill was substantially amended in the Senate and the 
        Assembly-approved version of this bill was deleted.  This bill, as 
        amended in the Senate, is inconsistent with Assembly actions.


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


        FN: 0005906