BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                  SB 161
                                                                  Page  1

          Date of Hearing:   June 28, 2011

              ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER 
                                     PROTECTION
                                 Mary Hayashi, Chair
                      SB 161 (Huff) - As Amended:  May 31, 2011

           SENATE VOTE  :   32-4
           
          SUBJECT  :   Schools: emergency medical assistance: administration 
          of epilepsy medication.

           SUMMARY  :   Allows school districts to train school employees who 
          volunteer to administer anti-seizure medication to students with 
          epilepsy.  Specifically,  this bill  :

          1)Provides that, in the absence of a credentialed school nurse 
            or other licensed nurse onsite at the school, a school 
            district may provide school employees with voluntary emergency 
            medical training to provide emergency medical assistance to 
            students with epilepsy suffering from seizures. 

          2)Requires a school employee with the training specified above 
            to provide emergency medical assistance using a training plan 
            approved on the California Department of Education's (CDE) 
            internet website, as specified, and performance instructions 
            set forth by the student's licensed health care provider.  A 
            school employee who does not volunteer or who has not been 
            trained pursuant to this bill's provisions shall not be 
            required to provide emergency medical assistance pursuant to 
            this bill.

          3)Allows the parent or guardian of a student with epilepsy, who 
            has been prescribed an emergency anti-seizure medication by 
            his or her health care provider, to request that a school have 
            one or more of its employees receive training pursuant to this 
            bill in the administration of an emergency anti-seizure 
            medication in the event that the student suffers a seizure 
            when a nurse is not available.  Upon such a request, the 
            school must: 

             a)   Notify the parent or guardian that his or her child may 
               qualify for services or accommodations under a Section 504 
               plan, pursuant to Section 504 of the federal Rehabilitation 
               Act of 1973 (Section 504); 








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             b)   Assist the parent or guardian with the exploration of 
               that option; and,

             c)   Encourage the parent or guardian to adopt that option if 
               it is determined that the child is eligible.

          4)Allows a school to ask the parent or guardian to sign a notice 
            verifying that the parent or guardian was given information 
            about Section 504, and that the parent or guardian understands 
            that it is his or her right to request a Section 504 plan at 
            any time.

          5)Allows a school to create an individualized health plan, 
            seizure action plan, or other appropriate health plan designed 
            to acknowledge and prepare for the child's health care needs 
            in school, if the parent or guardian does not choose to have 
            the student assessed for a Section 504 plan.  The plan may 
            include the involvement of trained volunteer school employees 
            or a licensed vocational nurse.

          6)Requires a school that elects to train employees pursuant to 
            this bill to ensure that:

             a)   A volunteer receives training from a licensed health 
               care professional regarding the administration of an 
               emergency anti-seizure medication.  A staff member who has 
               completed training shall, if he or she has not administered 
               an emergency anti-seizure medication within the prior two 
               years and there is a student enrolled in the school who may 
               need the administration of an anti-seizure medication, 
               attend a new training program to retain the ability to 
               administer an emergency anti-seizure medication;

             b)   Any agreement by an employee to administer an emergency 
               anti-seizure medication is voluntary, and an employee of 
               the school or school district shall not directly or 
               indirectly use or attempt to use his or her authority or 
               influence for the purpose of intimidating, threatening, 
               coercing, or attempting to intimidate, threaten, or coerce 
               any staff member who does not choose to volunteer, 
               including, but not limited to, direct contact with the 
               employee; and,

             c)   Any employee who volunteers pursuant to this section may 








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               rescind his or her offer to administer an emergency 
               anti-seizure medication up to three days after the 
               completion of the training. After that time, a volunteer 
               may rescind his or her offer to administer an emergency 
               anti-seizure medication with a two-week notice, or until a 
               new individual health plan or Section 504 plan has been 
               developed for an affected student, whichever is less.

          7)Requires a school that elects to train employees pursuant to 
            this bill to solicit volunteers exclusively via an electronic 
            notice to all staff that states the following information in 
            bold print:

             a)   A description of the volunteer request, stating that the 
               request is for volunteers to administer an emergency 
               anti-seizure medication to a student experiencing a severe 
               epileptic seizure, in the absence of a school nurse, and 
               that this emergency anti-seizure medication is a Food and 
               Drug Administration (FDA)-approved, pre-dosed, rectally 
               administered gel that reduces the severity of epileptic 
               seizures;

             b)   A description of the training that the volunteer will 
               receive, as specified;

             c)   A description of the voluntary nature of the volunteer 
               program, as specified; and,

             d)   The volunteer rescission timelines, as specified.

          8)Specifies that an employee who volunteers pursuant to this 
            bill shall not be required to administer an emergency 
            anti-seizure medication until completion of the training 
            program adopted by the school and documentation of completion 
            is recorded in his or her personnel file.

          9)Requires a school that elects to participate pursuant to this 
            bill to ensure that each volunteer will be provided defense 
            and indemnification by the school, in accordance with current 
            law governing claims and actions against public employees. 
            This information shall be reduced to writing, provided to the 
            volunteer, and retained in the volunteer's personnel file.

          10)Requires a school, if there are no volunteers, to re-notify a 
            student's parent or guardian of the option to be assessed for 








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            services and accommodations guaranteed under Section 504.

          11)Requires a school that elects to participate pursuant to this 
            bill to have a school plan in place that includes all of the 
            following:

             a)   Identification of existing licensed staff within the 
               district or region who could be trained in the 
               administration of an emergency anti-seizure medication and 
               could be available to respond to an emergency need to 
               administer an emergency anti-seizure medication. The school 
               shall consult with the school district or county office of 
               education to obtain this information;

             b)   Identification of students who may require the 
               administration of an emergency anti-seizure medication;

             c)   Written authorization from the parent or guardian for a 
               nonmedical school employee to administer an emergency 
               anti-seizure medication;

             d)   The requirement that the parent or guardian notify the 
               school if the student has had an emergency anti-seizure 
               medication administered within the past four hours on a 
               school day;

             e)   Notification of the parent or guardian that an emergency 
               anti-seizure medication has been administered; and,

             f)   A written statement from the student's health care 
               practitioner that includes specified information, including 
               (among other things) dosage, seizure symptoms, when to 
               administer medication, adverse reactions, a protocol for 
               observing the student after a seizure, and a requirement 
               that the student's parent and guardian and the school nurse 
               must be contacted following a seizure to continue the 
               observation protocol.

          12)Requires a school that elects to allow volunteers to 
            administer an emergency anti-seizure medication to compensate 
            a volunteer when the administration of an emergency 
            anti-seizure medication and subsequent monitoring of a student 
            requires a volunteer to work beyond his or her normally 
            scheduled hours.









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          13)Requires the State Department of Public Health (DPH), in 
            consultation with CDE, to develop guidelines for the training 
            and supervision of school employees in providing emergency 
            medical assistance to students with epilepsy suffering from 
            seizures.  The guidelines may be developed in cooperation with 
            interested organizations.  Upon development of the guidelines, 
            CDE shall approve the guidelines for distribution and make 
            those guidelines available upon request.

          14)Requires CDE to include on its internet web site a 
            clearinghouse for best practices in training non-medical 
            personnel to administer an emergency anti-seizure medication 
            to students.  Training established pursuant to this 
            requirement shall include, but not be limited to:

             a)   Recognition and treatment of different types of 
               seizures;

             b)   Administration of an emergency anti-seizure medication;

             c)   Basic emergency follow-up procedures, including, but not 
               limited to, calling the emergency 911 telephone number and 
               contacting the student's parent or guardian; and,

             d)   Techniques and procedures to ensure student privacy.

          15)Requires any written materials used in the training specified 
            in 14), above, to be retained by the school.

          16)Requires training established pursuant to 14), above, to be 
            conducted by one or more of the following:

             a)   A physician and surgeon;

             b)   A physician assistant;

             c)   A credentialed school nurse;

             d)   A registered nurse; or,

             e)   A certificated public health nurse.

          17)Provides that training provided in accordance with the 
            manufacturer's instructions, the student's health care 
            provider's instructions, and guidelines established pursuant 








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            to this bill shall be deemed adequate training for purposes of 
            this bill.

          18)Requires a school employee to notify the credentialed school 
            nurse assigned to the school district if he or she administers 
            an emergency anti-seizure medication pursuant to this bill.  
            If a credentialed school nurse is not assigned to the school 
            district, the school employee shall notify the superintendent 
            of the school district, or his or her designee.

          19)Requires a school to retain all records relating to the 
            administration of an emergency anti-seizure medication while a 
            student is under the supervision of school staff.

          20)Requires the student's parent or guardian to provide all 
            materials necessary to administer an emergency anti-seizure 
            medication, including the statement from the student's health 
            practitioner, as specified.  A school shall not be responsible 
            for providing any of the necessary materials.

          21)Provides the following definitions:

             a)   An "emergency anti-seizure medication" means diazepam 
               rectal gel and emergency medications approved by the FDA 
               for patients with epilepsy for the management of seizures 
               by persons without the medical credentials listed in 16), 
               above; and,

             b)   "Emergency medical assistance" means the administration 
               of an emergency anti-seizure medication to a student 
               suffering from an epileptic seizure.

          22)Specifies findings and declarations.

          23)Sunsets January 1, 2017.

           EXISTING LAW  

          1)Pursuant to the Americans with Disabilities Act (ADA) of 1990, 
            prohibits discrimination on the basis of disability by 
            employers, public accommodations, state and local governments, 
            public and private transportation, and in telecommunications.

          2)Pursuant to the Individuals with Disabilities Education Act 
            (IDEA), governs Individualized Educational Programs (IEPs) and 








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            the special education process.  IDEA guarantees children with 
            disabilities a free appropriate public education (FAPE) in the 
            least restrictive environment (LRE).

          3)Pursuant to Section 504, provides federal financial assistance 
            to state and local education agencies to guarantee special 
            education and related services to eligible children with 
            disabilities. 

          4)Requires school districts to provide FAPE to each qualified 
            person with a disability who is in the school district's 
            jurisdiction, regardless of the nature or severity of the 
            person's disability, which includes reasonable accommodations 
            required for the management of chronic medical conditions. 

          5)Requires the governing board of any school district to give 
            diligent care to the health and physical development of 
            students, which may include employing properly certified 
            persons.  

          6)Provides that each student who is required to take medication 
            prescribed by a physician may be assisted by the school nurse 
            or other designated school personnel if the school district 
            receives a written statement from the physician detailing the 
            method, amount, and time schedules by which the medication is 
            to be taken, and a written statement from the parent or 
            guardian of the student indicating the desire that the school 
            district assist the student in the matters set forth in the 
            physician's statement.

          7)Provides that no school district, officer of any school 
            district, school principal, physician, or hospital treating a 
            student shall be held liable for the reasonable treatment of a 
            child without the consent of a parent or guardian when the 
            child is ill or injured during regular school hours, requires 
            reasonable medical treatment, and the parent or guardian 
            cannot be reached, unless the parent or guardian has 
            previously filed with the school district a written objection 
            to any medical treatment other than first aid.

          8)Authorizes non-medical school personnel to administer the 
            following medication to a student in an emergency, after 
            receiving specified training:

             a)   Emergency epinephrine auto-injectors.  A prescription 








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                                                                  Page  8

               for an auto-injector for a specific student is not 
               required; the prescription is for the school.  

             b)   Glucagon may be administered to students with diabetes 
               suffering from severe hypoglycemia in the absence of a 
               credentialed school nurse or other licensed nurse onsite at 
               the school.

          9)Authorizes non-medical school personnel to assist or 
            administer medication to a student on a routine, non-emergency 
            basis as follows:

             a)   Assisting in the administration of prescribed 
               medication, or in the self-administration of prescription 
               auto-injectable epinephrine.  

             b)   Assisting in administration of prescribed medication or 
               in the self-administration of prescription inhaled asthma 
               medication. 

             c)   Assisting if the health care provider gives a written 
               statement with specific information, such as the medication 
               the student is to take, the dosage, and the period of time 
               during which the medication is to be taken, and if the 
               parent provides a written statement initiating a request to 
               have the medication administered or otherwise assisted in 
               the administration of the medication.  

          10)Establishes the scope of practice for nursing through the 
            Nursing Practice Act (NPA), which includes the administration 
            of medication, and prohibits any person from engaging in the 
            practice of nursing without a license.

          11)Licenses and regulates the practice of nursing by the Board 
            of Registered Nursing (BRN).

           FISCAL EFFECT  :   Unknown

           COMMENTS  :   

           Purpose of this bill  .  According to the author's office, "Some 
          children with epilepsy are susceptible to prolonged seizures and 
          require access to a lifesaving emergency medication?For over ten 
          years it was common in California schools to have Registered 
          Nurses, or where unavailable, trained non-medical personnel 








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          (teachers, aides, office staff) to administer doctor prescribed 
          Diastat in an emergency situation to a student when suffering a 
          severe, possibly life threatening, seizure.  In October 2009, 
          however, a nursing education consultant to the BRN advised that 
          there is no provision in the NPA for unlicensed school personnel 
          to administer Diastat.  The consultant then concluded that 
          absent an authorizing statute, school nurses cannot train or 
          supervise unlicensed personnel to administer Diastat.  

          "As a consequence of the letter, nurses are refusing to train 
          school personnel, and schools are reluctant to have staff, even 
          those already trained, administer Diastat.  Some schools are 
          telling parents they must be available to come to the school to 
          administer Diastat (the drug must be administered in about five 
          minutes) or are calling 911 in an emergency.  Either of these 
          solutions results in delays in treatment that places the child 
          in danger of serious injury, or worse."

           Background  .  Epilepsy is a chronic neurological condition in 
          which the individual is susceptible to seizures, which can range 
          from a brief disruption of senses, muscle spasms, or odd 
          sensations to periods of unconsciousness and convulsions.  There 
          is no known cure for epilepsy.

          Epilepsy is a complex condition and there are many types of 
          seizures associated with epilepsy.  The type of seizure a person 
          has depends on a variety of factors, such as the part of the 
          brain affected and the underlying cause of the seizure.  The 
          type of medicine individuals with epilepsy take depends on the 
          type of seizures. 

          Nearly three million people in the U.S. have some form of 
          epilepsy, with about 200,000 new cases of seizure disorders and 
          epilepsy diagnosed each year.  According to the Epilepsy 
          Foundation, as many as 325,000 school-age children ages five 
          through 14 have epilepsy.  Epilepsy affects more than 90,000 
          children in California.  

          Diastat, a trademark administration system of diazepam, was 
          first approved for use in the United States by the FDA in 1997 
          as a treatment for breakthrough seizures in adults and children 
          two years old and older.  It is the only FDA-approved, at-home 
          medication for the treatment of acute repetitive seizures, or 
          "cluster" seizures.  Diastat was specifically developed to be 
          administered by people without medical training and is 








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          considered the fastest, safest and most effective way to treat 
          epileptic seizures.  Dosages are determined on an individual 
          basis, depending upon the condition to be treated, the severity 
          of symptoms, the body weight of the patient, and any comorbidity 
          conditions the patient may have.  

          Diastat is intended to be kept handy so that a caregiver can 
          attempt to stop seizures by administering the drug relatively 
          quickly.  Diastat is a gel formulation of diazepam (valium) that 
          is administered rectally.  The delivery system includes a 
          plastic applicator with a flexible, molded tip and is provided 
          in fixed unit-doses of five, 10, 15 and 20 mg.  A pharmacist 
          dials the syringe to the physician's prescribed dosage before it 
          is dispensed to the patient.  

          Most seizure patients, no matter how well-managed through 
          maintenance medication, will likely experience breakthrough 
          seizures throughout their lifetime.  As many as 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. 

          There are numerous children with special medical needs in 
          California's classrooms.  California's nurse-to-student ratio is 
          approximately 1:2,200.  According to the California Basic 
          Educational Data System (CBEDS), about one-half of school 
          districts do not have a school nurse.  

          Two federal anti-discrimination statutes, Section 504 and Title 
          II of the ADA, establish rights for eligible students in 
          California's public schools.  They serve to protect students 
          from discrimination based upon their disability.  In general, a 
          student will be determined to have a disability under Section 
          504 if he/she has a mental or physical impairment that 
          substantially limits one or more major life activities, such as 
          eating, breathing, caring for oneself, performing manual tasks, 
          hearing, speaking, walking, and learning. 

          Section 504 requires school districts to provide FAPE to each 
          qualified student, regardless of the nature or severity of the 
          disability.  An appropriate education may consist of education 
          in regular classes, education in regular classes with the use of 








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          related aids and services, or special education and related 
          services in separate classrooms for all or portions of the 
          school day. 

          A 504 plan differs from an individualized education program 
          (IEP).  An IEP provides for specialized instruction, while a 504 
          plan provides for accommodation due to a physical or mental 
          impairment that does not require specialized instruction.  
                              
          The NPA specifies that medication administration is a nursing 
          function that cannot be performed by unlicensed personnel unless 
          expressly authorized by statute.  Current law authorizes 
          non-medical school personnel to administer emergency epinephrine 
          auto-injectors in an emergency after receiving specified 
          training (Education Code, Section 49414).  Current law also 
          allows Glucagon to be administered to students with diabetes 
          suffering from severe hypoglycemia in the absence of a 
          credentialed school nurse or other licensed nurse onsite at the 
          school (Education Code, Section 49414.5).

          The BRN issued a legal opinion in March 2010 on the 
          administration of Diastat to students by unlicensed school 
          personnel, stating, "The NPA does not permit unlicensed school 
          personnel to administer Diastat to a student undergoing an 
          epileptic seizure.  Diastat is a medication and its 
          administration constitutes the practice of nursing.  A school 
          district's use of unlicensed school personnel to administer 
          Diastat to fulfill its duty to provide medical services to 
          students undergoing seizure is not exempt from the NPA.

          "The NPA does not permit a nurse to train unlicensed school 
          personnel knowing that the purpose for the training is to enable 
          the trainees to administer Diastat to a student, and the 
          unlicensed person actually administers Diastat in violation of 
          the NPA.  Such conduct may subject the nurse to discipline for 
          aiding and abetting the unlicensed practice of nursing.

          "The NPA does not permit a nurse to establish and supervise a 
          program where unlicensed school personnel administer Diastat to 
          students during the school day.  Such conduct may subject the 
          nurse to discipline for being a departure from the standards of 
          competent performance established in (the California Code of 
          Regulations) in that he or she would be delegating a health care 
          task to a person who is not legally able to perform that task."









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           Support  .  Epilepsy California states, "(We have) received 
          numerous complaints from parents, teachers, school nurses and 
          medical providers regarding children being denied access to 
          Diastat in the school setting.  A student suffering from 
          prolonged seizures that is prescribed and yet denied access to 
          this emergency rescue medication risks permanent brain damage or 
          death.  Unfortunately, simply calling 911 is not an appropriate 
          response as there is no guarantee that an ambulance will arrive 
          to the school within the critical first five minutes of the 
          onset of the seizure.  After five minutes, seizures are life 
          threatening.

          "The FDA approved Diastat with the intended purpose of 
          non-medical personnel (such as parents and teachers) to be able 
          to safely administer the medicine.  After all, seizures are 
          unpredictable and can happen anywhere.  This medicine is 
          portable and able to be administered in virtually every setting. 
           Knowledgeable and informed medical professionals testify to the 
          efficacy and safety of this medication, even when administered 
          by non-medical personnel.  There is no basis to the argument 
          that Diastat is unsafe.  However, prolonged seizures are 
          deadly."

           Opposition  .  The California Teachers Association writes, "Our 
          members representing educators, school nurses, and classified 
          employees all believe that protecting the rights, safety and 
          health of students and all school personnel is paramount and SB 
          161 misses the mark on several levels including not identifying 
          the source of funding involved in the 'emergency medical 
          training;' failure to recognize there are multiple types of 
          epileptic seizures, does not address maintaining the privacy and 
          dignity of the student experiencing a seizure, the liability 
          issues if the medication is not administered properly, and the 
          time necessary to stay with the student suffering the seizure to 
          observe them for side effects.

          "The administration of Diastat must be conducted in a safe and 
          private manner by trained medical personnel who understand the 
          numerous issues associated with administering medications.  We 
          believe the implementation of SB 161 would lead to, rather than 
          prevent, dangerous outcomes for students."

           Related legislation  .  SB 65 (Strickland) authorizes any student 
          who has been diagnosed with cystic fibrosis and is required to 
          take, during the regular school day, medication prescribed for 








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          him or her by a physician or surgeon, to be assisted by the 
          school nurse or other designated school personnel, or may carry 
          and self-administer prescription pancreatic enzymes if the 
          school district receives specified written statements.  SB 65 is 
          pending in Senate Education Committee.

           Previous legislation  .

          SB 1051 (Huff) of 2010 authorizes a school district, until 
          January 1, 2016, to provide non-licensed school employees with 
          voluntary training for the provision of emergency medical 
          assistance to a pupil suffering from an epileptic seizure, in 
          the absence of licensed personnel.  This bill was held in Senate 
          Appropriations.

          AB 1802 (Hall) of 2010 permits a parent or guardian to designate 
          a school employee to administer insulin during school, as 
          specified.  This bill was held in Assembly Business, 
          Professions, and Consumer Protection Committee. 

          SB 1200 (Leno) of 2010 requires the Department of Managed Health 
          Care and the Insurance Commissioner to develop regulations to 
          ensure timeliness of care for school age children who must 
          receive medically necessary services during school hours.  This 
          bill was held in Assembly Appropriations Committee. 

          AB 2454 (Torlakson) of 2010 requires the governing board of a 
          school district to employ at least one school nurse, registered 
          nurse, or licensed vocational nurse for every 750 students, and 
          requires registered nurses and licensed vocational nurses to 
          provide health care services to students under the supervision 
          of a school nurse.  This bill was held in Assembly 
          Appropriations Committee.

          AB 1430 (Swanson) of 2009 requires any necessary medication to 
          be administered to a student by a licensed health care 
          professional operating within the scope of his or her practice.  
          This bill was held in Assembly Business and Professions 
          Committee.

          AB 426 (Hall) of 2009 requires the CDE, in consultation with 
          specified entities, to recommend to the Legislature ways to 
          address specific health-related needs of students on school 
          campuses.  This bill was held in Assembly Education Committee.









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          AB 942 (Leno), Chapter 684, Statutes of 2003, authorizes each 
          school district to provide voluntary emergency medical training 
          to school personnel to administer emergency medical assistance 
          to students with diabetes suffering from severe hypoglycemia, as 
          specified. 

          AB 559 (Wiggins), Chapter 458, Statutes of 2001, authorizes a 
          school district or county office of education to provide 
          emergency epinephrine auto-injectors to trained personnel, and 
          authorizes the trained personnel to utilize those epinephrine 
          auto-injectors to provide emergency medical aid to persons 
          suffering from an anaphylactic reaction.

           REGISTERED SUPPORT / OPPOSITION  :

           Support 
           
          Orange County Department of Education (sponsor)
          American Academy of Pediatrics, California District
          California Association of Physician Groups
          California Association of School Business Officials
          California Association of Suburban School Districts
          California County Superintendents Educational Services 
          Association
          California Medical Association
          California School Boards Association
          Children's Specialty Care Coalition
          Democrats for Education Reform
          Developmental Disabilities Area Board 10
          Disability Rights California
          Epilepsy California
          Epilepsy Foundation
          Health Officers Association of California
          Humboldt County Office of Education
          Kern County Superintendent of Schools
          Los Angeles County Board of Supervisors
          Los Angeles County Office of Education
          Los Angeles Unified School District
          Orange Unified School District
          Riverside County School Superintendents' Association
          Riverside Unified School District
          Saddleback Valley Unified School District
          San Bernardino County District Advocates for Better Schools
          San Francisco Unified School District
          Small School Districts' Association








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          Torrance Unified School District
          Numerous individuals

          Opposition 
           
          American Federation of State, County and Municipal Employees
          American Nurses Association-California
          California Association for Nurse Practitioners
          California Federation of Teachers
          California Labor Federation
          California Nurses Association
          California School Employees Association, AFL-CIO
          California School Nurses Organization
          California Teachers Association
          Laborers International Union of North America, Local 777
          SEIU California
          Service Employees International Union-Nurses Alliance of 
          California
          United Nurses Association of CA-Union of Health Care 
          Professionals
          United Teachers Los Angeles
          Numerous individuals

           Analysis Prepared by  :    Angela Mapp / B.,P. & C.P. / (916) 
          319-3301