FINDING OF EMERGENCY
Administration of Epilepsy Medication: Emergency Medical Assistance
The State Board of Education (SBE) finds that an emergency exists and that the emergency regulations adopted are necessary to avoid serious harm to the public peace, health, safety, or general welfare, especially for pupils attending public schools.
SPECIFIC FACTS DEMONSTRATING THE EXISTENCE OF AN EMERGENCY AND THE NEED FOR IMMEDIATE ACTION
More than 90,000 children in California have epilepsy, a common symptom of which is seizures. Many seizure patients, despite maintenance medication, experience breakthrough seizures. Up to 35% of patients on anti-seizure medications may not be adequately controlled. Between 50,000 and 200,000 generalized convulsive status epileptic seizures occur every year in the United States, with an overall mortality rate of 20%. Status seizures lasting more than one hour have a mortality rate of 32%, compared with 2.7% for seizures of shorter duration. California's nurse-to-student ratio is approximately 1:2,200. According to the California Basic Educational Data System, about one-half of school districts do not have a school nurse.
The legislature has determined that the health of students with epilepsy who suffer severe seizures at school is compromised without access to emergency medical assistance. SB 161 authorizes school districts, county offices of education, and charter schools, in the absence of a school nurse, to provide emergency medical assistance to such pupils through trained volunteer nonmedical school personnel. Any such emergency medical assistance must be provided in accordance with the guidelines encompassed in these regulations. Adopting these emergency regulations will allow school districts, county offices of education, and charter schools to provide emergency medical assistance, in the absence of a school nurse, to address this serous student health issue.
The emergency regulations clarify important points for persons affected by the statute, and in particular, students with epilepsy. For example, the statute is silent as to the definition of a school day within which an emergency anti-seizure medication may be administered. This silence, and the resulting lack of clarity on the part of educational agencies as to that issue, could have serious harmful effects on the health of students with epilepsy. Specifically, a student with epilepsy attending a before- or after-school program could be left, in the absence of a school nurse, without trained staff authorized to administer an emergency anti-seizure medication, thus seriously compromising his or her health. The emergency regulations, consistent with other provisions of Title 5 of the California Code of Regulations, clarify that the school day during which an emergency anti-seizure medication may be administered may include times such as before- and after-school programs. This clarity will ensure that educational agencies who participate in the program are prepared to meet the students’ health needs.
Also, the statute is silent as to the definition and content of supervision. This silence, and the resulting lack of clarity on the part of educational agencies as to that issue, could negatively affect educational agencies’ decisions as to whether to participate in the program. Specifically, an educational agency might assume that direct supervision is required and, due to the difficulty this may present in some schools, thereby choose not to participate in the program, leaving a student with epilepsy, in the absence of a school nurse, without trained staff authorized to administer an emergency anti-seizure medication, thus seriously compromising his or her health. The emergency regulations, consistent with other provisions of Title 5 of the California Code of Regulations, clarify that supervision of the trained volunteer does not necessarily require the immediate presence of the supervisor at all times. This clarity will ensure that educational agencies do not decline participation in the program because of lack of clarity as to what supervision will entail, and should ensure that more educational agencies participate in the program and address the students’ health needs.
FACTS EXPLAINING THE FAILURE TO ADDRESS THE SITUATION THROUGH NONEMERGENCY REGULATIONS
Senate Bill 161 was signed by the Governor on October 7, 2011 (Statutes of 2011, Chapter 560), became effective on January 1, 2012, and requires that guidelines on training and supervision of volunteer nonmedical personnel be posted by July 1, 2012. The CDE has been fulfilling its obligation under SB 161 to consult with the Department of Public Health (DPH) in the development of the guidelines, and has also sought the input of other interested organizations. Given that the SBE meets on a bimonthly basis, and is a public body that meets pursuant to the requirements of Bagley-Keene, it would be difficult, if not impossible, to promulgate regulations that would satisfy the July 1, 2012 date through the normal rulemaking process.
Following the signing of the bill on October 7, 2011, the dates of the next regularly scheduled SBE meetings were November 9-10, 2011, January 11-12, 2012, and March 7-8, 2012. The SBE’s policies and procedures require that items for Board meetings be presented two months in advance. Thus, by the time the bill was signed, the deadline for submitting items for the November, 2011 meeting had passed and there was only approximately one month remaining before the deadline for submitting items for the January, 2012 meeting. Given that the CDE was required to consult with DPH, and also sought the input of other interested organizations, in developing the regulations, it was not practical to submit regulations in time for the January, 2012 meeting. Accordingly, given the July 1, 2012 deadline, emergency regulations were prepared and submitted for the March, 2012 meeting.
REASON FOR DUPLICATION
Government Code section 11349 prohibits unnecessary duplication of state or federal statutes in regulation. In this case, duplication of certain state and federal statutes is necessary in the proposed emergency regulations in order to provide clarity to the reader and allow he or she to find all applicable references in one place [1 CCR § 12(b)(1)]. Because the regulations address training and supervision, it is necessary to duplicate portions of the statute relating to training and supervision in order to give proper context to the regulations.
AUTHORITY AND REFERENCE
Authority: Sections 33031 and 49414.7, Education Code. Reference: Section 49414.7, Education Code.
This emergency regulations package will implement the provisions of Education Code section 49414.7, which became effective January 1, 2012. The Legislature passed Senate Bill (SB) 161 and it was signed by the Governor on October 7, 2011 (Statutes of 2011, Chapter 560). SB 161 authorizes 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—and with a parent’s written authorization—emergency medical assistance to pupils with epilepsy suffering from seizures, in accordance with guidelines to be developed by the California Department of Education (CDE) in consultation with the State Department of Public Health. The CDE is required to post these guidelines on its Web site by July 1, 2012. These emergency regulations are being proposed because SB 161 states that the training must be “consistent” with the guidelines and that a nonmedical school employee who has completed the voluntary training and provides assistance “shall” provide assistance “using the guidelines.” Because the guidelines are to be rules of general application that implement SB 161, it is necessary to adopt them as regulations.
The legislature emphasized pupil safety concerns in passing SB 161, finding that “the safety and welfare of a pupil with epilepsy is compromised without immediate access to an emergency anti-seizure medication” and that “in the absence of a credentialed school nurse or other licensed nurse onsite at the school, it is in the best interest of the health and safety of children to allow trained school employees to administer an emergency anti-seizure medication to pupils in public schools.”
The Legislature relied on the American Academy of Pediatrics and the Epilepsy Foundation of America, both of which support training of school employees to administer an emergency anti-seizure medication and believe that an emergency anti-seizure medication may be safely and effectively administered by trained school employees. Diastat is a trademark administration system of diazepam (valium) and is currently the only FDA-approved, at-home medication for the treatment of acute repetitive seizures, or "cluster" seizures. Diastat, a rectally-administered gel, was specifically developed to be administered by people without medical training and is considered the fastest, safest and most effective way to treat epileptic seizures.
TECHNICAL, THEORETICAL, AND/OR EMPIRICAL STUDIES, REPORTS, OR DOCUMENTS
The SBE did not consider any technical, theoretical, empirical study, reports, or other documents in the drafting these regulations.
MANDATE ON LOCAL AGENCIES OR SCHOOL DISTRICTS
The proposed regulations do not impose a mandate on school districts, county offices of education, or charter schools because participation is voluntary.
The SBE has assessed the potential for significant adverse economic impact that might result from the proposed emergency regulatory action and it has been determined that:
- There will be no costs or savings to the State.
- There will be no non-discretionary costs or savings to local agencies.
- There will be no costs or savings on local agencies or school districts.
- There will be no costs or savings in federal funding to the State.
03-22-12 [California Department of Education]