BILL ANALYSIS Ó AB 491 Page 1 CONCURRENCE IN SENATE AMENDMENTS AB 491 (Ma) As Amended August 30, 2012 2/3 vote. Urgency ----------------------------------------------------------------- |ASSEMBLY: | |(May 31, 2011) |SENATE: |29-3 |(August 31, | | | | | | |2012) | ----------------------------------------------------------------- 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). AB 491 Page 2 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. AB 491 Page 3 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 AB 491 Page 4 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. AB 491 Page 5 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, AB 491 Page 6 as amended in the Senate, is inconsistent with Assembly actions. Analysis Prepared by : Tanya Robinson-Taylor / HEALTH / (916) 319-2097 FN: 0005875