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 (more) SB 1266 (Huff) Page 2 of ? 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 SB 1266 (Huff) Page 3 of ? 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 SB 1266 (Huff) Page 4 of ? 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 SB 1266 (Huff) Page 5 of ? 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, SB 1266 (Huff) Page 6 of ? 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." SB 1266 (Huff) Page 7 of ? 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 SB 1266 (Huff) Page 8 of ? 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 SB 1266 (Huff) Page 9 of ? 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 SB 1266 (Huff) Page 10 of ? 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) **************