BILL ANALYSIS                                                                                                                                                                                                    Ó






                             SENATE JUDICIARY COMMITTEE
                         Senator Hannah-Beth Jackson, Chair
                              2013-2014 Regular Session


          SB 1266 (Huff)
          As Amended April 21, 2014
          Hearing Date: April 29, 2014
          Fiscal: Yes
          Urgency: No
          RD


                                        SUBJECT
                                           
                      Pupil Health: Epinephrine Auto-Injectors

                                      DESCRIPTION  

          Existing law authorizes every public and private school to  
          voluntarily determine whether to make emergency epinephrine  
          available at its school and allows trained personnel to  
          volunteer to use epinephrine auto-injectors to provide emergency  
          medical aid to persons suffering from anaphylactic reaction, as  
          specified. 

          This bill would make the existing provisions mandatory by  
          requiring public schools to have a trained volunteer to  
          administer epinephrine auto-injectors in emergencies and would  
          require that each employee who volunteers is provided defense  
          and indemnification by the school district, county office of  
          education, or charter school for any and all civil liability, as  
          specified.  Additionally, the bill would: 
           mandate certain reporting by the school nurse or designated  
            employee, and by the school district, county office of  
            education, or charter school, after each school year; 
           add new training requirements;
           specify that the Superintendent must review the minimum  
            training standards for the administration of epinephrine  
            auto-injectors every five years; and  
           authorize funding, as specified. 

                                      BACKGROUND  

          An epinephrine auto-injector is a disposable medical drug  
          delivery device that delivers a single measured dose of  
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          epinephrine, most frequently for the treatment of acute allergic  
          reactions to avoid or treat the onset of anaphylactic shock.   
          Anaphylactic shock can quickly result in death if untreated.   
          Epinephrine auto-injectors can be obtained by prescription only,  
          and California law does not authorize non-physicians to  
          administer an epinephrine auto-injector to another person,  
          except in limited circumstances.   

          In recent years, California law has been amended to, among other  
          things, permit school districts or county offices of education  
          to provide emergency epinephrine auto-injectors to trained  
          personnel, and to permit trained personnel to utilize the  
          auto-injectors to provide emergency medical aid to persons  
          suffering from an anaphylactic reaction, as it is not uncommon  
          for children to come into contact with specific allergens (such  
          as bee stings) or accidentally ingest foods they are allergic to  
          at school.  (AB 559 (Wiggins, Ch. 458, Stats. 2001).)  

          This bill would require, as opposed to simply authorize, school  
          districts, county offices of education, and charter schools to  
          provide emergency epinephrine auto-injectors to trained  
          personnel who, consistent with existing law, may use the  
          auto-injectors to provide emergency medical aid to persons  
          suffering from anaphylactic reaction. Each public school would  
          be required to designate one or more school personnel on a  
          voluntary basis to receive the requisite training for these  
          purposes, while each private school would retain their current  
          authority to voluntarily determine whether or not to make  
          emergency epinephrine auto-injectors and trained personnel  
          available at its school.  This bill would also require that each  
          employee who volunteers be provided defense and indemnification  
          by the school district, county office of education, or charter  
          school for any and all civil liability, as specified. 

          This bill was previously heard by the Senate Education Committee  
          and the Senate Health Committee on April 2 and April 24, 2014,  
          respectively. 

                                CHANGES TO EXISTING LAW
           
           Existing law  , the Government Tort Claims Act, specifies rules of  
          civil liability that apply to public entities and public  
          employees in California.  (Gov. Code Sec. 810 et seq.)

           Existing law  , in relevant part, permits a school district or  
          county office of education to provide emergency epinephrine  
                                                                      



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          auto-injectors to trained personnel, and permits trained  
          personnel to utilize those epinephrine auto-injectors to provide  
          emergency medical aid to persons suffering from an anaphylactic  
          reaction.  Existing law prohibits any school district or county  
          office of education choosing to exercise this authority from  
          receiving funds specifically for these purposes.  (Ed. Code Sec.  
          49414(a).) 

           Existing law  , in relevant part, authorizes each public and  
          private elementary and secondary school in the state to  
          voluntarily determine, as specified, whether or not to make  
          emergency epinephrine auto-injectors and trained personnel  
          available at its school.  (Ed. Code Sec. 49414(c).)
           
          Existing law  permits each public and private school to designate  
          one or more personnel on a voluntary basis to receive initial  
          and annual refresher training, based on specified standards,  
          regarding the storage and emergency use of an epinephrine  
          auto-injector from the school nurse or other qualified person  
          designated by the school district physician, the medical  
          director of the local health department, or the local emergency  
          medical services director.  Existing law prohibits any school  
          choosing to exercise this authority from receiving state funds  
          for these purposes. (Ed. Code Sec. 49414(d).)

           Existing law  permits a school nurse, or if the school does not  
          have a school nurse, a person who has received training, as  
          specified, to do the following:
           obtain from the school district physician, the medical  
            director of the local health department, or the local  
            emergency medical services director a prescription for  
            epinephrine auto-injectors; and
           immediately administer an epinephrine auto-injector to a  
            person exhibiting potentially life-threatening symptoms of  
            anaphylaxis at school or a school activity when a physician is  
            not immediately available.  (Ed. Code Sec. 49414(f).)  

           Existing law  requires the Superintendent of Public Instruction  
          to establish minimum standards of training for the  
          administration of epinephrine auto-injectors that satisfy the  
          minimum statutory training requirements, as specified.  Existing  
          law requires that the Superintendent consult with specified  
          organizations and providers with expertise in administering  
          epinephrine auto-injectors and administering medication in a  
          school environment.  (Ed. Code Sec. 49414(e)(1).)   Existing law  
          also provides minimum training requirements and standards, as  
                                                                      



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          specified.  (Ed. Code Sec. 49414(e)(2).)

           Existing law  authorizes a school district, county office of  
          education, or charter school, in the absence of a credentialed  
          school nurse or other licensed nurse onsite at the school, to  
          participate in a program, as specified, to allow non-medical  
          school personnel to administer anti-seizure medication to a  
          pupil with epilepsy in an emergency, after receiving certain  
          training.  (Ed. Code Sec. 49414.7.) 

           Existing law  provides that if a school district, county office  
          of education, or charter school elects to participate pursuant  
          to this section, the school district, county office of  
          education, or charter school shall ensure that each employee who  
          volunteers will be provided defense and indemnification by the  
          school district, county office of education, or charter school  
          for any and all civil liability, in accordance with, but not  
          limited to, that provided under the Government Tort Claims Act.  
          This information shall be reduced to writing, provided to the  
          volunteer, and retained in the volunteer's personnel file.  (Ed.  
          Code Sec. 49414.7(i).) 

           This bill  would instead require school districts, county offices  
          of education, and charter schools to provide emergency  
          epinephrine auto-injectors to trained personnel.  Each public  
          school would be required to designate one or more personnel on a  
          voluntary basis to receive the required training, as specified,  
          and would be required to designate and have trained at least one  
          person for certain purposes.  Each private elementary and  
          secondary school in the state would retain the existing  
          authority to determine whether or not to make emergency  
          epinephrine auto-injectors available at its school.

           This bill  would require a school nurse, or if the school does  
          not have nurse or one is not onsite or available, a school  
          administrator or his or her designee who has received the  
          requisite training, to obtain from the local educational agency  
          physician or other specified persons a prescription for  
          epinephrine auto-injectors, and specify that the prescription  
          must at a minimum include one adult and one junior epinephrine  
          auto-injector.  This bill would also authorize the prescription  
          to be filled by local or mail order pharmacies or epinephrine  
          auto-injector manufacturers. 

           This bill  would require a school district, county office of  
          education, or charter school to ensure that each employee who  
                                                                      



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          volunteers under this bill is provided defense and  
          indemnification by the school district, county office of  
          education, or charter school for any and all civil liability, in  
          accordance with, but not limited to, that provided under the  
          Government Tort Claims Act. This bill would require this  
          information to be reduced to writing, provided to the volunteer,  
          and retained in the volunteer's personnel file.  

           This bill  would specify that the Superintendent must review the  
          minimum standards of training required for the administration of  
          epinephrine auto-injectors every five years.  This bill would  
          add to the existing training requirements that training shall  
          include instruction on how to determine whether to use an adult  
          or junior epinephrine auto-injector.  The bill would also  
          require that the training be consistent with specified  
          guidelines by the federal Centers for Disease Control. 

           This bill  would require that, no later than 30 days after the  
          last day of each school year, the school nurse or designated  
          employee shall report any incident of epinephrine auto-injector  
          use to the school district, county office of education, or  
          chartering authority on a form developed by the department.   
          This bill would require that the school district, county office  
          of education, or chartering authority report any incident of  
          epinephrine auto-injector use to the department on the form  
          developed by the department.  This bill would also require the  
          department to annually publish the results of the submitted  
          forms on its Internet Web site, without violating state and  
          federal privacy laws. 

           This bill  would authorize state funding for certain purposes for  
          which state funding was previously prohibited and would further  
          allow a public school to accept gifts, grants, and donations  
          from any source for the support of the public school carrying  
          out the provisions of this bill, including but not limited to,  
          the acceptance of epinephrine auto-injectors from a manufacturer  
          or wholesaler. 

           This bill  would make other related and technical changes. 

                                        COMMENT
           
          1.   Stated need for this bill  

          According to the author, 

                                                                      



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            Approximately 6 million children under the age of 18 suffer  
            from life threatening allergies.  That is one in every 13  
            children - or [two] in every classroom.  Approximately 25  
            percent of first time allergic reactions that require  
            epinephrine happen at school.  Because they have no knowledge  
            of this, they do not have the necessary lifesaving medication  
            on hand.  Also, children with known allergies are being sent  
            to school without epinephrine for several reasons including  
            cost, non-understanding of the severity of the allergy by  
            parents, the prohibitive nature of the school process for  
            leaving medication.  

            Anaphylaxis is a potentially lethal allergic reaction.  It can  
            happen when a person is stung by a bee, ingests food such as  
            shellfish or nuts, or maybe even just comes in contact with  
            something as simple as latex. Epinephrine is the first line of  
            treatment for someone who is experiencing anaphylaxis. It can  
            be easily administered and has very little side-effect.   
            Reactions can be so severe, even fatal, without prompt use of  
            epinephrine.  

            Current law requires prescription for epinephrine be made to a  
            specific student in order for the medication to be stored at  
            schools so it can be used in case of a anaphylactic reaction  
            during school hours.  Current California law also allows  
            schools to stock epinephrine, but has not required it.

            SB 1266 will require extra epinephrine injectors be prescribed  
            as a "standing order" so epinephrine can be on hand in all  
            public schools in the event of an severe allergic reaction.   
            SB 1266 will allow volunteers to be trained for identifying  
            anaphylaxis and administering the necessary medication,  
            epinephrine.  It will also provide defense and indemnification  
            for those volunteering to administer (this language came from  
            existing law as provided under [Ed. Code Sec.] 49414.7 (i)).
           
          The sponsor of this bill, Food Allergy Research & Education  
          (FARE), adds, "[e]pinephrine is the only medication that can  
          arrest the symptoms of a severe reaction."  FARE cites a study  
          in a medical journal (Pediatrics) that "showed that 24 percent  
          of epinephrine use in a school district was on those without a  
          previous diagnosis of food allergy.  Many children may not know  
          they are allergic and do not have prescribed epinephrine.   
          Precious minutes can be lost waiting for emergency responders.   
          There are no counter-indications to administering epinephrine,  
          but delaying its use may have catastrophic results."
                                                                      



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          2.   Indemnification and defense for volunteers
           
          All private and public schools in this state are authorized  
          under existing California law to voluntarily determine whether  
          or not to make epinephrine available at their schools.  This  
          bill would not modify this existing authorization for private  
          schools but would require all public schools to designate one or  
          more volunteer school personnel to train and use epinephrine  
          auto-injectors to provide emergency medical aid to persons  
          suffering from anaphylactic reaction, as specified.  

          As noted by the California School Nurses Organization, "[t]his  
          bill will serve to protect those children who are not known to  
          have allergies by providing a safety mechanism-the epinephrine  
          auto-injectors (epi-pens) which will protect them from any  
          severe reaction.  Many school children fall prey to undiagnosed  
          allergies and those with asthma or poorly controlled asthma are  
          at a higher risk of allergic reactions."

          Another supporter of the bill, the CA, Allergy Support &  
          Anaphylaxis Prevention argues that even though California law  
          authorizes school districts to have stock epinephrine in  
          schools, "very few have actually taken advantage of implementing  
          this."  

          As a practical matter, however, the success of this bill depends  
          on a teacher or other school employee volunteering to be  
          designated for this purpose.  Recognizing that employees may  
          hesitate to volunteer out of fear of personal liability, this  
          bill would require that a school district, county office of  
          education, or charter school ensure that each employee who  
          volunteers be provided defense and indemnification by the school  
          district, county office of education, or charter school for any  
          and all civil liability.  The bill would also require that this  
          information be reduced to writing, provided to the volunteer,  
          and retained in the volunteer's personnel file.

          Staff notes that this language is modeled upon an existing  
          provision of the Education Code which provides authorization for  
          schools to allow nonmedical employees to administer medical  
          assistance to pupils with epilepsy suffering from seizures.   
          (See Ed. Code Sec. 49414.7(i).)   The language would appear to  
          preserve any recourse that the students and their families might  
          have under existing law for injuries suffered as a result of the  
          administration of the epinephrine auto-injector, while still  
                                                                      



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          affording adequate protection from the costs of litigation and  
          any liability for damages thereof to volunteering employees who  
          attempt to render life-saving emergency care in accordance with  
          their training.  

          3.    Opposition concerns  

          Staff notes three organizations, the California Teachers  
          Association (CTA), California Federation of Teachers, and the  
          California School Employees Association (CSEA), that have  
          submitted letters of opposition to the prior versions of this  
          bill.  The CSEA took a position of oppose unless amended, and  
          specifically noted in their letter that their concerns regarding  
          liability protection would be addressed with the indemnification  
          language that the author subsequently amended into the bill.   
          Additionally, CSEA argued that the bill needed to (1) make clear  
          that the designated employees be volunteers, (2) clarify who  
          will be paying for the epinephrine auto-injectors, and (3)  
          include an appropriation or some funding mechanism to pay for  
          itself.  

          CTA's letter raised concerns that: (1) reactions to epinephrine  
          could go beyond the scope of training provided to school  
          personnel; (2) probationary or temporary and/or classified  
          employees could be "highly encouraged" to volunteer against  
          their will; and (3) this bill creates a "one size fits all  
          statute" by individuals without necessary medical and  
          pharmaceutical expertise to take into account potential  
          unintended consequences. 

          The California Federation of Teachers argued that a mandate  
          requiring all schools to have this device, where they are  
          already authorized to do so, is unnecessary and costly.  They  
          also had liability related concerns and argued that schools  
          should be employing a full time nurse to be responsible for  
          administering all medications to students that need it.  With  
          respect to the liability concerns, Committee staff notes that  
          the letter was submitted prior to the addition of the  
          indemnification and defense language to this bill.  Staff also  
          notes that significant amendments were taken in the Health  
          Committee, which appear to have addressed some of the other  
          non-liability related concerns. (See Comment 4 below.)

          4.    Author's amendments  

          This bill was approved by the Senate Health Committee on April  
                                                                      



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          24, 2014.  Due to procedural timing constraints, the author  
          committed to taking the following amendments in this Committee  
          to: 
           ensure that the required training includes standards and  
            procedures for the restocking of epinephrine auto-injectors;
           ensure that the required documentation include information as  
            to when the medication was restocked; 
           clarify that the school nurse or school administrator would be  
            responsible to be trained, obtain, and administer an  
            epinephrine auto-injector if no school personnel are willing  
            to volunteer; 
           clarify that if the school does not have a school nurse, or if  
            the school nurse is not onsite or available, a school  
            administrator is responsible for obtaining the requisite  
            epinephrine auto-injectors and strike any references to the  
            volunteering designee with respect to this particular  
            responsibility;
           ensure any references to designated employees also reflect  
            that the designee is a volunteer; and
           make other technical and clarifying changes. 


           Support  :  American Academy of Allergy, Asthma and Immunology  
          (AAAI); American Red Cross; Asthma and Allergy Foundation of  
          America (AAFA); Bay Area Allergy Advisory Board; Bay Area Food  
          Allergy 5k Walk/Run in Memory of BJ HOM; California Advocates  
          for people with Food Allergies (CAFA); California Allergy  
          Support & Anaphylaxis Prevention (CAASAP); California Chapter of  
          the American College of Emergency Physicians (California ACEP);  
          California Society of Allergy, Asthma and Immunology (CSAAI);  
          California School Nurses Organization (CSNO); Food Allergy and  
          Anaphylaxis Connection Team (FAACT); Food Allergy Support of  
          Sacramento (FASS); Kids with Food Allergies (KFA); Natalie  
          Giorgi Sunshine Foundation; Northern California Allergy & Asthma  
          Advocates (NCAAA);
          Nut Free Wok; Orange County Taxpayers Association; San Diego  
          Food Allergy Support Group; San Francisco Bay Area Food Allergy  
          Network; Sanofi; South Orange County Food Allergy Network; San  
          Clemente Food Allergy Support Group; Stanford Food Allergy &  
          Food Sensitivity Center Community Council; Sutter Medical Group;  
          numerous individuals

           Opposition  :  California Federation of Teachers; California  
          School Employees Association (oppose unless amended); California  
          Teachers Association

                                                                      



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                                        HISTORY
           
           Source  :  Food Allergy Research and Education 

           Related Pending Legislation  :  None Known

           Prior Legislation  :

          SB 669 (Huff, Ch. 725, Stats. 2013), among other things,  
          authorized a trained pre-hospital emergency medical care person,  
          first responder, or lay rescuer to obtain and use epinephrine  
          auto-injectors to render emergency care to another person,  
          pursuant to specified requirements, and granted them limited  
          liability, as specified.  

          SB 161 (Huff, Ch. 560, Stats. 2011) authorized a school  
          district, county office of education, or charter school to  
          participate in a program to provide nonmedical school employees  
          with voluntary emergency medical training to provide, in the  
          absence of a credentialed school nurse or other licensed nurse  
          onsite at the school or charter school, emergency medical  
                                                                      assistance to pupils with epilepsy suffering from seizures, in  
          accordance with specified guidelines.  SB 161 also provided each  
          employee who volunteers under the bill with defense and  
          indemnification by the school district, county office of  
          education, or charter school, for any and all civil liability,  
          as specified. 

          AB 559 (Wiggins, Ch. 458, Stats. 2001), See Background. 

          AB 1791 (Wiggins, 1999) was similar to AB 559, above, but was  
          ultimately vetoed by the Governor. 

           Prior Vote  :

          Senate Health Committee (Ayes 9, Noes 0)
          Senate Education Committee (Ayes 7, Noes 0)

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