BILL ANALYSIS                                                                                                                                                                                                    






                        SENATE HEALTH AND HUMAN SERVICES
                               COMMITTEE ANALYSIS
                        Senator Deborah V. Ortiz, Chair


          BILL NO:       AB 1369                                      
          A
          AUTHOR:        Pavley                                       
          B
          AMENDED:       June 12, 2003
          HEARING DATE:  June 18, 2003                                
          1
          FISCAL:        Judiciary / Appropriations                   
          3
                                                                      
          6
          CONSULTANT:                                                 
          9
          Vazquez / sl
                                        

                                     SUBJECT
                                         
             Residential care facilities for the elderly: automatic  
                            external defibrillators

                                     SUMMARY  

          This bill requires residential care facilities for the  
          elderly (RCFEs) with more than 60 beds to purchase  
          automatic external defibrillators (AEDs) and train their  
          staff in its use. 

                                     ABSTRACT  

          Existing law:
          1.Provides that the Department of Social Services is  
            responsible for issuing licenses to RCFEs.  No person may  
            operate or maintain an RCFE without a current valid  
            license or special permit.

          2.Defines RCFE as a housing arrangement chosen voluntarily  
            by persons 60 years of age or over, or their authorized  
            representative, where varying levels and intensities of  
            care and supervision, protective supervision, or personal  
            care are provided, based upon their varying needs.  "Care  
                                                         Continued---



          STAFF ANALYSIS OF ASSEMBLY BILL 1369 (Pavley)         Page  
          2


          
            and supervision" is defined to mean that the facility  
            assumes responsibility for, or provides ongoing  
            assistance with, activities of daily living without which  
            the resident's physical health, mental health, safety, or  
            welfare would be endangered.  Assistance includes  
            assistance with taking medications, money management, or  
            personal care.  

          3.Defines automatic external defibrillator as a  
            lightweight, portable device used to administer an  
            electric shock through the chest wall to the heart.   
            Built-in computers assess the patient's heart rhythm,  
            determine whether defibrillation is needed and if so,  
            administer the shock.  Audible and/or visual prompts  
            guide the use through the process.

          4.Provides protection from civil liability for good  
            samaritans who, in good faith and not for compensation,  
            render emergency care or treatment by the use of an AED  
            at the scene of an emergency.  Additionally, a person or  
            entity that provides cardiopulmonary resuscitation (CPR)  
            and AED training to a person who renders such emergency  
            care in good faith and not for compensation is also  
            immune from liability for any civil damages resulting  
            from any acts or omissions of the person rendering the  
            emergency care. 

          5.Authorizes, by regulation, but does not require, RCFEs to  
            maintain and operate an AED if all of the following  
            requirements are met:

                 The licensee notifies DSS in writing that an AED is  
               in the facility and will be used in accordance with  
               all applicable federal and state requirements.

                 The licensee maintains at the facility a training  
               manual from an American Heart Association or American  
               Red Cross-recognized AED training class, a copy of the  
               required physician's prescription for the AED, a log  
               of checks of operation of the AED, a copy of a valid  
               AED operator's certificate for any employees  
               authorized by the licensee to operate the AED, and a  
               log of quarterly proficiency demonstrations for each  
               holder of an AED operator's certificate.  

                                                         Continued---




          STAFF ANALYSIS OF ASSEMBLY BILL 1369 (Pavley)         Page  
          3


          
          1.Requires at least one employee per AED unit in the RCFE  
            to complete a training course in CPR and AED use that  
            complies with regulations adopted by the Emergency  
            Medical Services Authority (EMSA) and the standards of  
            the American Heart Association or the Red Cross.

          2.Requires the RCFE to have trained employees who should be  
            available to respond to an emergency that may involve the  
            use of an AED unit during normal operating hours. 

          3.Requires, by regulation, RCFEs operating AEDs to observe  
            a do-not-resuscitate (DNR) order, advance directives, and  
            requests to forego resuscitative measures.  

          4.Prohibits individuals who require health services for or  
            have a health condition including, but not limited to,  
            the following from being admitted into or retained in  
            RCFEs: stage 3 and 4 dermal ulcers, gastrostomy care, use  
            of liquid oxygen, naso-gastric tubes, staph infection or  
            other serious infection, tracheostomies, or those who  
            depend on other to perform all activities of daily living  
            for them.  Limits the types of health care assistance  
            that RCFEs may provide to:  administration of oxygen,  
            catheter care, colostomy/ileostomy care; contractures;  
            diabetes; enemas; incontinence; injection; intermittent  
            positive pressure breathing machine; stage 1 and 2 dermal  
            ulcers; and wound care.  The types of health care  
            assistance that may be provided for such conditions is  
            further regulated.

          This bill:
          1.Requires, commencing January 1, 2005, every RCFE with a  
            licensed bed capacity that exceeds 60 persons to  
            purchase, and train personnel in the use of, an AED  
            consistent with current state law, as outlined under (2)  
            and (3) below.  

          2.Provides that the training of RCFE personnel and use of  
            AEDs must meet any minimum standards established by EMSA.  
             

          3.Provides that all RCFEs must comply with all regulations  
            governing the placement of an AED, to ensure that the AED  
            is maintained and regularly tested according to operation  
            and maintenance guidelines, to ensure that the AED is  
                                                         Continued---




          STAFF ANALYSIS OF ASSEMBLY BILL 1369 (Pavley)         Page  
          4


          
            checked for readiness after each use or at least once  
            every 30 days, whichever is sooner, and to have a written  
            plan that describes the procedures to be followed in the  
            event of an emergency that may involve the use of an AED.  


          4.Stipulates that (a) an employee of an RCFE who uses an  
            AED to render emergency care or treatment, or (b) the  
            members of the board of directors of the facility may not  
            be held liable for civil damages resulting from acts or  
            omissions in rendering the emergency care or treatment of  
            a resident by use of an AED, except in the case of  
            personal injury or wrongful death that results from gross  
            negligence or willful or wanton misconduct.

          5.Clarifies that the requirement to render emergency  
            treatment by use of an AED does not authorize its use  
            contrary to a request to forego resuscitative measures,  
            an advance directive, or a DNR.  

          6.Provides that if a resident executes a request to forego  
            resuscitative measures, an advance directive, or a DNR,  
            the resident shall indicate separately, in writing, if he  
            or she does not want facility employees to use an AED if  
            he or she needs emergency care or treatment.  

                                  FISCAL IMPACT  

          According to the Assembly Committee on Appropriations, the  
          costs of the measure to RCFEs are unknown.  RCFEs are  
          privately funded, which makes estimation of the costs of  
          purchasing and training related to AEDs difficult to  
          determine.  AEDs cost between $1,500 and $3,000 each and  
          training by the American Red Cross is approximately $45 per  
          participant.  It is not known how many facilities covered  
          by this bill already have AEDs, however, it is expected  
          that approximately 600 RCFEs with 60 beds or more will  
          qualify for inclusion under this mandate.  

          Due to the fact that RCFEs are funded through monthly  
          private payments from individuals and because the  
          Department of Social Services (DSS) already has regulations  
          governing the use of AEDs in RCFE, this bill does not have  
          an impact on state or local government costs.

                                                         Continued---




          STAFF ANALYSIS OF ASSEMBLY BILL 1369 (Pavley)         Page  
          5


          
                            BACKGROUND AND DISCUSSION  

          Background 
          According to the author, "At least 450,000 cases of  
          unexpected cardiac arrest occur annually in the United  
          States, and the majority of these cases occur in places  
          other than hospitals.  Studies have shown that when  
          defibrillators are used immediately on cardiac arrest  
          victims, the survival rate is almost 100 percent.  But  
          because traditional emergency medical services take 8 to 15  
          minutes to respond, the overall survival rates for cardiac  
          arrest victims in most U.S. communities are only 5 to 10  
          percent."  The author further notes that despite the proven  
          success of quick defibrillation, and the availability of  
          AEDs that can be easily placed in a variety of locations  
          and used by non-medical personnel, facilities that house  
          and care for senior citizens oftentimes do not have AEDs on  
          the facilities' premises.  

          This bill mandates that large RCFEs with a bed capacity  
          exceeding 60 persons maintain and operate AEDs.  As part of  
          this requirement, training of personnel must be consistent  
          with any minimum standards established by EMSA.  RCFEs must  
          ensure that the AED is maintained and regularly tested,  
          periodically checked for readiness, and that records of  
          those checks are maintained.  Additionally, at least one  
          employee per AED unit in the RCFE is required to complete a  
          training course in CPR and AED use that complies with  
          regulations adopted by EMSA and the standards of the  
          American Heart Association or the Red Cross.  Furthermore,  
          the RCFE is required to have trained employees who should  
          be available to respond to an emergency that may involve  
          the use of an AED unit during normal operating hours. 

          The author states that AEDs should become increasingly  
          available in care facilities for the elderly, making RCFEs  
          an important starting point given the average age and  
          health status of seniors residing in these facilities.  The  
          American Heart Association reports that 84% of cardiac  
          arrest victims are age 65 or older.  If large facilities  
          that care for seniors were to have AEDs on site, seniors  
          would benefit from the availability of this technology.  

          Liability exemptions
          Although state regulations do permit RCFEs to maintain and  
                                                         Continued---




          STAFF ANALYSIS OF ASSEMBLY BILL 1369 (Pavley)         Page  
          6


          
          operate AEDs, it appears that few currently do so.  This  
          bill would turn the permissive regulation into a mandate  
          for the larger RCFEs.  In addition to imposing this  
          mandate, this bill extends the liability protections to  
          employees and members of boards of directors of facilities,  
          similar to that recently enacted in "good samaritan"  
          provisions that exist for those who render aid "in good  
          faith" and "not for compensation" (please see "Related  
          legislation" below).  The immunity from liability does not  
          exist to the extent that the injury or death that resulted  
          was due to gross negligence or willful or wanton  
          misconduct.  

          Anticipated costs to RCFEs
          According to the author, the approximate cost of an AED is  
          between $1,500 and $3,000.  Additionally, standard CPR  
          training by the American Red Cross, which includes training  
          on AED use, costs $45 per person.  The author comments that  
          this cost is negligible when compared with the cost the  
          state and the counties incur when having to care for  
          patients that sustain major medical injuries and  
          disabilities as a result of delayed resuscitation.  The  
          actual cost to the RCFE is unknown, depending on the number  
          of staff that must be trained and how often such training  
          must be readministered.  

          As noted above, this bill would require RCFEs to have  
          trained employees who should be available to respond to an  
          emergency that may involve the use of an AED unit during  
          normal operating hours.  The normal operating hours for  
          RCFEs are 24 hours a day.  This requirement likely means,  
          therefore, that there needs to be trained personnel  
          available on every shift, at least one per AED, who could  
          respond in case of an emergency.

          Honoring of DNRs
          The author has included language in the most recent  
          amendments intended to reconcile the use of AEDs and  
          existing DNRs and advance directives.  The bill now  
          requires that a separate, written "opt-out" form be used  
          for residents who have DNRs or other advance directives and  
          who do not wish for an AED to be used if emergency care or  
          treatment is needed.  

          Generally, a DNR order tells medical professionals not to  
                                                         Continued---




          STAFF ANALYSIS OF ASSEMBLY BILL 1369 (Pavley)         Page  
          7


          
          perform CPR.  This means that doctors, nurses, and  
          emergency medical personnel will not attempt emergency CPR  
          if the patient's breathing or heartbeat stops.  DNR orders  
          may be written for patients in a hospital, nursing home, or  
          residential facility, as well as for patients at home.   
          Hospital DNR orders tell the medical staff not to revive  
          the patient if cardiac arrest occurs.  If the patient is in  
          a nursing home or at home, the DNR order tells the staff  
          and emergency medical personnel not to perform emergency  
          resuscitation and not to transfer the patient to a hospital  
          for CPR. 

          Further conditions may be added governing the use of DNRs  
          and advance directives (e.g. effective if the patient is  
          terminally ill and the use of life-sustaining procedures  
          would serve only to artificially delay the moment of  
          death).  Advance health care directives may or may not  
          include provisions regarding defibrillation.  

          The opposition states that over 50% of residents in RCFEs  
          have DNRs in place, complicating administration of how DNR  
          and AED administration are reconciled.  

          Arguments in support 
          The American Red Cross of California states that AB 1369  
          would provide a vulnerable population with access to  
          easy-to-use, life-saving devices.  The California  
          Professional Firefighters agree, noting that AB 1369 would  
          enhance the likelihood of a cardiac arrest victim's  
          survival by making AEDs readily available.  MedTronic  
          Physio-Control, a leading maker of AEDs, also supports the  
          bill.  MedTronic notes that almost anyone can learn to  
          operate an AED with a few hours of training and that no  
          medical background is needed.  AEDs are designed to help  
          people with minimal training to safely use them in tense,  
          emergency situations.  They have numerous built-in  
          safeguards and are designed to deliver a shock only if the  
          AED detects that one is necessary.  MedTronic estimates  
          that approximately 27,000 Californians die from sudden  
          cardiac arrest each year.  Wide use of defibrillators could  
          save as many as 6,000 lives in California each year.  

          Arguments in opposition 
          The California Assisted Living Association (CALA) opposes  
          this legislation, stating that this mandate is  
                                                         Continued---




          STAFF ANALYSIS OF ASSEMBLY BILL 1369 (Pavley)         Page  
          8


          
          inappropriate in a setting where there is a concentration  
          of people who have indicated that they do not want to be  
          resuscitated.  "AB 1369 exposes RCFEs to additional  
          liability and will increase costs to residents?This  
          additional exposure will likely increase liability  
          insurance premiums, which have skyrocketed in the past two  
          years.  All of this impacts the affordability of assisted  
          living services."  CALA also argues that implementation in  
          their settings is complicated, and that the requirement for  
          AEDs in other settings was removed from the bill because  
          the potential limited benefit did not outweigh the  
          financial cost to the state, i.e. Medi-Cal reimbursement.   
          "Since RCFEs do not receive Medi-Cal funding, providers and  
          residents will bear the costs of this mandate." 

           Pilot project.   In addition, CALA have suggested that the  
          measure be narrowed to instead authorize a pilot project,  
          in which AED placement in a lower number of RCFEs could be  
          tested for implementation successes, challenges, and  
          questions.  The form and scope of a pilot has not been  
          developed.  

          Related legislation 
          SB 911 (Figueroa, Chapter 163, Statutes of 1999) provides  
          immunity from civil liability to individuals who in good  
          faith, and not for compensation, render emergency care or  
          treatment by the use of an AED at the scene of an  
          emergency.  Similarly, immunity is provided for the person  
          or entity who provides CPR and AED training to the  
          individual who rendered the emergency care, as well as the  
          person or entity who acquired the AED and a physician or  
          other person who is involved with the placement and  
          location of the AED.  The immunity does not attach for  
          damages resulting from the gross negligence or willful or  
          wanton misconduct of the person who renders emergency care.

          AB 2041 (Vargas, Chapter 718, Statutes of 2002) deletes the  
          requirement that a person administering an AED complete a  
          basic CPR or AED course in order to receive immunity.  The  
          bill would further provide immunity from civil liability to  
          a person or entity that acquires an AED for emergency use  
          and renders emergency care, if that person or entity is in  
          compliance with specified requirements.

          AB 1145 (Shirley Horton), currently under consideration by  
                                                         Continued---




          STAFF ANALYSIS OF ASSEMBLY BILL 1369 (Pavley)         Page  
          9


          
          the Senate Committee on Governmental Organization, would  
          require the Department of General Services to apply for  
          specified federal funds for the purchase of automated  
          external defibrillators to be located within state-owned  
          and leased buildings.  It would require the Department of  
          General Services, in consultation with the Emergency  
          Medical Services Authority, the American Red Cross, and the  
          American Heart Association to develop and adopt policies  
          and procedures relative to the placement and use of  
          automated external defibrillators in state-owned and leased  
          buildings and ensure that training is consistent with  
          specified requirements.

          Suggested amendments 
          CALA has proposed the following two amendments related to  
          the DNR provision (page 3, lines 21-25 of the June 12  
          amended version): 

          1.Additional language is needed to explicitly authorize  
            AED-trained RCFE personnel to withhold the use of an AED  
            notwithstanding any California law to the contrary with  
            respect to the honoring of DNR orders.  

          2.Provide an opt-out or waiver of AED use for patients who  
            have not completed an advance health care directive or  
            DNR order.  

          The author has agreed to take amendments to reach  
          clarification on these two points.  

          Pending amendments in Judiciary Committee
           Facility-wide liability.   The author intends to work with  
          the Judiciary Committee to further address the issue of  
          liability exemption in the bill, allowing for facility-wide  
          protection.  It is the author's intent to achieve an  
          agreement on amendments that provide for liability  
          exemption while retaining requirements for adequate  
          training of staff and oversight of implementation by RCFEs.  
           Amendments in this area will be deferred to the Judiciary  
          Committee.  

          Issues for consideration for the Committee
          The Committee may wish to consider the following issues  
          that have arisen in discussions with the author and  
          stakeholders on this measure:
                                                         Continued---




          STAFF ANALYSIS OF ASSEMBLY BILL 1369 (Pavley)         Page  
          10


          
           
          1.Details on implementation and need for regulations.  
            The author and Committee, with the input of stakeholders,  
            may wish to consider amendments that will assist in the  
            definition of implementation, such as providing that the  
            list of those patients who opt-out of AED use be posted  
            in the facility or perhaps packaged with the actual AED,  
            allowing for easier reference.  An additional provision  
            may also govern how DNR or advance directives that  
            include instructions that either permit or preclude the  
            use of an AED can be translated into a separate file for  
            easier reference and use by staff.  

            The process of presenting opt-out forms to residents  
            (e.g. at the time of signing an admission agreement) and  
            the regularity of updating them (e.g. on an annual or  
            biennial basis) can also be considered for further  
            development in the bill.  RCFEs currently maintain and  
            execute DNRs, therefore it may be worthy to consider a  
            like and parallel system to present, process, maintain,  
            update, and make known to staff the directive of a  
            patient in the use of AEDs.
             
            2.Changing effective date of mandate.   
            Currently in the bill, the mandate takes effect in  
            January 1, 2005, one year after enactment.  The author  
            may wish to adjust this or institute time periods for  
            phases of implementation in order to address the concern  
            that facilities will not have ample time to revise RCFE  
            policies and procedures in accordance with the act.  
           
          3.Using broader definition of "advance health care  
            directive."  
            DSS has suggested and the author may consider an  
            amendment to use the broader term of "advance health care  
            directive," which as a legal term, generally includes  
            DNRs, requests to forego certain measures, living wills,  
            and durable power of attorney.  The following amendment  
            will achieve this (starting at page 3, line 21): 
            "(2) If a resident executes an advance health care  
            directive, including, but not limited to, a request to  
            forego resuscitative measures, an advance directive, or a  
            do-not-resuscitate order?"


                                                         Continued---















                                  PRIOR ACTIONS

           Assembly Floor:          53 - 22  Pass
          Assembly Appropriations: 19 - 2    Do Pass
                                                                                      Assembly Human Services:   5 - 0    Do Pass As Amended

                                    POSITIONS  

          Support:       California Senior Legislature (Sponsor)
                         American Heart Association
                         American Red Cross of California
                         California Medical Association
                         California Professional Firefighters
                         Congress of California Seniors
                         Emergency Medical Services Administrator's  
          Association
                            of California
                         Federation of Retired Union Members of
                            Santa Clara and San Benito Counties
                         Medtronic Physio-Control
                         Three Individuals

          Oppose:   California Association of Homes and Services for  
          the Aging
                         California Assisted Living Association






                                   -- END --
          







                                                         Continued---