BILL ANALYSIS                                                                                                                                                                                                    Ó






                             SENATE COMMITTEE ON HEALTH
                          Senator Ed Hernandez, O.D., Chair

          BILL NO:       AB 491
          AUTHOR:        Ma
          AMENDED:       August 24, 2012
          HEARING DATE:  August 29, 2012
          CONSULTANT:    Marchand

           SUBJECT  :  Health facilities.
           
          SUMMARY  :  Deletes a requirement that cardiac catheterization 
          laboratory services be located in a hospital, as long as the 
          laboratory space is connected to the general acute care hospital 
          by an enclosed all-weather passageway, performs no more than 25 
          percent of its procedures on hospital inpatients, and meets 
          other specified requirements.

          Existing law:
          1.Licenses and regulates general acute care hospitals by the 
            Department of Public Health (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 the Office of Statewide Health Planning and Development 
            (OSHPD).  

          6.Exempts from the definition of "hospital building," for 
                                                         Continued---



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            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 percent 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. 
          
          This bill:
          1.Deletes the requirement that a cardiac catheterization 
            laboratory service be located in a general acute care 
            hospital.

          2.Permits cardiac catheterization laboratory services, beginning 
            on March 1, 2013, to be expanded by a general acute care 
            hospital to include cardiac catheterization space that is in 
            conformance with applicable building code standards, including 
            those promulgated by OSHPD, as long as all of the following 
            occur:
                  a.        The expanded laboratory space is located in 
                    the building so that the space is connected by an 
                    enclosed all-weather passageway that is accessible by 
                    staff and patients who are accompanied by staff;
                  b.        The service performs no more than 25 percent 
                    of its procedures on hospital inpatients; and,
                  c.        The service complies with all policies and 
                    procedures approved by hospital medical staff, and all 
                    standards and regulations prescribed by DPH, including 
                    applicable nurse-to-patient ratios, and with all 
                    standards and regulations prescribed by OSHPD.  

          3.Requires emergency regulations permitting a general acute care 
            hospital to operate a cardiac catheterization laboratory 
            service to be adopted by DPH and OSHPD by February 28, 2013.

          4.Requires cardiac catheterization laboratory services to be 




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            reviewed by OSHPD for compliance with the OSHPD 3 requirements 
            of the most recent version of the California Building 
            Standards Code.

           FISCAL EFFECT  :  Unknown.

           PRIOR VOTES  :  Prior votes not relevant. 

           COMMENTS  :  
           1.Author's statement.  With the passage of the Affordable Care 
            Act, California will see an increase in patients seeking 
            access and care in a health system with limited resources and 
            already at capacity.  There is also a national trend toward 
            wellness and early intervention by treating problems before 
            they require hospitalization. This is good not only for 
            patients but also for managing the overall cost of healthcare. 
            In order to provide increased services to these newly covered 
            patients, plus those seeking earlier intervention, California 
            hospitals will need to utilize all resources available in 
            order to treat patients in a timely manner.

            Cardiac services are in great demand and hospitals can better 
            serve some of these patients in an outpatient setting. Under 
            current law, DPH has no authority to allow cardiac 
            catheterization services to be performed in an outpatient 
            setting. This bill seeks to resolve this dilemma by amending 
            the law to allow qualified hospitals to perform cardiac 
            catheterization services in an outpatient setting. This bill 
            will allow no more than 25 percent of cardiac catheterization 
            laboratory inpatient services to be performed in an 
            appropriately equipped and staffed outpatient setting. Should 
            an emergency arise that requires cardiac surgery service 
            support, the bill requires the outpatient cardiac 
            catheterization space be located in a building connected by an 
            enclosed all weather passageway to a general acute care 
            hospital. The cardiac catheterization physician will determine 
            which patients will be treated in the outpatient cardiac 
            catheterization laboratory setting based on the type of 
            procedure and condition of the patient. In order to improve 
            access to health care for patients requiring cardiac 
            catheterization services at the earliest possible time.
            
          2.Coronary catheterization?  According to the National Heart 
            Lung and Blood Institute, cardiac catheterization is a medical 
            procedure used to diagnose and treat some heart conditions. A 




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            long, thin, flexible tube called a catheter is put into a 
            blood vessel in the arm, groin (upper thigh), or neck and 
            threaded to the heart. Through the catheter, doctors can do 
            diagnostic tests and treatments on the heart. A special type 
            of dye can be put in the catheter to facilitate x-ray pictures 
            of the heart and coronary arteries, called a coronary 
            angiography. Physicians can also treat cardiac heart disease 
            during catheterization using a procedure called angioplasty, 
            where a catheter with a balloon at its tip is threaded to the 
            blocked coronary artery. Once in place, the balloon is 
            inflated, pushing the plaque against the artery wall to create 
            a wider path for blood to flow to the heart. Sometimes a small 
            mesh tube, called a stent, is placed in the artery during 
            angioplasty to support the inner artery wall.

          3.Related legislation.  SB 276 (Corbett), pending in Assembly 
            Rules Committee, requires DPH to promulgate regulations 
            regarding the type of medical procedures that can be performed 
            in the cardiac catheterization laboratory of a hospital that 
            also has on-site cardiac surgery services, and permits 
            hospitals to perform certain specified procedures until such 
            regulations are adopted.  

          4.Support.  This bill is sponsored by the California Hospital 
            Association (CHA), which states that with the passage of the 
            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 states that OSHPD currently 
            allows up to 25 percent 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 percent 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.

          Cedars-Sinai Medical Center (Cedars) states in support that it 




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            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.
          
          5.Opposition.  The California Nurses Association (CNA) opposes 
            this bill, stating that it is an end-of-session "gut and 
            amend" that would completely alter the settings in which 
            cardiovascular procedures are performed in California and 
            would significantly and negatively impact patient care in 
            California. CNA states that this bill would take 
            catheterization laboratories into an outpatient clinic-like 
            setting where hospital inpatients would have cardiac 
            catheterization procedures performed in buildings that skirt 
            seismic requirements by being licensed under clinic building 
            standards rather than standards and regulations for hospitals. 
            CNA also opposes the use of the emergency regulations, which 
            are required to be adopted by February of 2013, to implement 
            this change in the provision of cardiac catheterization 
            services. Rapidly implementing regulations would deny DPH the 
            immediate benefit of public input into a significant change in 
            the manner in which care is provided to consumers. If these 
            proposed changes have any merit, they need to be considered 
            during the regular full session to allow the public and 
            Legislature more time to consider this major change in the 
            provision of high risk health care services.

          This bill is also opposed by the United Nurses Associations of 
            California/Union of Health Care Professionals (UNAC/UHCP), 
            stating that it is their view that conducting cardiac 
            catheterization procedures on an outpatient basis, even on the 
            campus of a hospital, is unsafe.  UNAC/UHCP states that if 
            something goes wrong during the procedure, the patient will 
            need care within seconds or minutes, minutes that do not allow 




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            a patient to be transported from an outpatient facility to an 
            inpatient facility. The hospital campuses where such 
            procedures might be conducted are generally very large 
            physical plants where a patient could be literally a block or 
            more from the inpatient facility.
          
          6.Drafting errors.

               a.     Incorrect nurse staffing ratio reference. The 
                 provision of this bill requiring the cardiac 
                 catheterization laboratory service to comply with 
                 applicable nurse-to-patient ratios incorrectly cites the 
                 nurse staffing ratios for long-term care facilities, 
                 rather than for hospitals. The author is proposing 
                 amendments to correct this statutory cross-reference. 
                 Specifically, the amendments would do the following: On 
                 page 4, line 23, strike "1276.5" and insert "1276.4".

               b.     A catheterization laboratory licensed to perform 
                 cardiac surgery? The provision of this bill deleting the 
                 requirement that a catheterization laboratory be located 
                 in a general acute care hospital also changed other 
                 wording in a way that requires the cardiac 
                 catheterization laboratory  itself  to either be licensed 
                 to perform cardiac surgery or have a licensed intensive 
                 care unit and a written transfer agreement to another 
                 hospital with cardiac surgery services. The statute 
                 should continue to require the  hospital  to either be 
                 licensed to perform cardiac surgery or have a written 
                 agreement for transfer to another hospital, not the 
                 laboratory.  The author may wish to consider an amendment 
                 to address this error. 
          
           SUPPORT AND OPPOSITION  :
          Support:  California Hospital Association (sponsor)
                    Association of California Healthcare Districts
                    Cedars-Sinai Medical Center
                    Scripps Health

          Oppose:   California Nurses Association
          United Nurses Associations of California/Union of Health Care 
                    Professionals

                                      -- END --
          





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